BEGIN:VCALENDAR VERSION:2.0 PRODID:-//pdufa.bio//catalyst calendar//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:pdufa.bio FDA catalysts X-WR-CALDESC:FDA PDUFA dates, advisory committees and clinical readouts. En tries spanning several days are estimates known only to that month or quar ter. REFRESH-INTERVAL;VALUE=DURATION:PT12H X-PUBLISHED-TTL:PT12H BEGIN:VEVENT UID:readout_agio_2026-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260601 DTEND;VALUE=DATE:20260701 SUMMARY:~AGIO Readout: Mitapivat DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T07055243 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/AGIO TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ardx_2026-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260601 DTEND;VALUE=DATE:20260701 SUMMARY:~ARDX Readout: Tenapanor DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06810167 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_bmy_2026-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260601 DTEND;VALUE=DATE:20260701 SUMMARY:~BMY Readout: Nivolumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/BMY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_celc_2026-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260601 DTEND;VALUE=DATE:20260701 SUMMARY:~CELC Readout: Gedatolisib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/CELC TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_clls_2026-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260601 DTEND;VALUE=DATE:20260701 SUMMARY:~CLLS Readout: UCART22 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT04150497 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/ticker/CLLS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cmps_2026-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260601 DTEND;VALUE=DATE:20260701 SUMMARY:~CMPS Readout: COMP360 psilocybin DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: CNS . Status: Estimated. Primary source: https://clinicaltrials.gov/study/NCT0 6247839 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_jazz_2026-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260601 DTEND;VALUE=DATE:20260701 SUMMARY:~JAZZ Readout: Zanidatamab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/JAZZ TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_legn_2026-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260601 DTEND;VALUE=DATE:20260701 SUMMARY:~LEGN Readout: LCAR-B38M CAR-T Cell DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06395870 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_olma_2026-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260601 DTEND;VALUE=DATE:20260701 SUMMARY:~OLMA Readout: Palazestrant DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT06016738 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ptct_2026-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260601 DTEND;VALUE=DATE:20260701 SUMMARY:~PTCT Readout: PTC923 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05166161 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/PTCT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tlx_2026-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260601 DTEND;VALUE=DATE:20260701 SUMMARY:~TLX Readout: 177Lu-TLX591 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/TLX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_trvi_2026-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260601 DTEND;VALUE=DATE:20260701 SUMMARY:~TRVI Readout: Nalbuphine ER Tablets DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T07036029 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_wve_2026-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260601 DTEND;VALUE=DATE:20260701 SUMMARY:~WVE Readout: WVE-210201 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Rar e disease. Status: Estimated. Primary source: https://clinicaltrials.gov/s tudy/NCT04906460 Source: pdufa.bio. Informational only\, not investment ad vice. URL:https://www.pdufa.bio/ticker/WVE TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_gsk_2026-06-18@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260618 DTEND;VALUE=DATE:20260619 SUMMARY:GSK PDUFA: Tebipenem HBr (SPR994) - (PIVOT-PO) DESCRIPTION:Confirmed date. Status: Decided. Outcome: Approved. Across 1\,8 27 FDA decisions since 2020\, the median peak run-up from T-120 was 17.8% and the median move from T-120 to the day before the decision was 1.8%. Pa st behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/GSK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_spro_2026-06-18@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260618 DTEND;VALUE=DATE:20260619 SUMMARY:SPRO PDUFA: Tebipenem HBr (SPR994) - (PIVOT-PO) DESCRIPTION:Confirmed date. Status: Decided. Outcome: Approved. Across 1\,8 27 FDA decisions since 2020\, the median peak run-up from T-120 was 17.8% and the median move from T-120 to the day before the decision was 1.8%. Pa st behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/SPRO TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_achv_2026-06-20@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260620 DTEND;VALUE=DATE:20260621 SUMMARY:ACHV PDUFA: Cytisinicline - (ORCA-3) DESCRIPTION:Confirmed date. Status: Decided. Outcome: CRL. Across 1\,827 FD A decisions since 2020\, the median peak run-up from T-120 was 17.8% and t he median move from T-120 to the day before the decision was 1.8%. Past be haviour\, not a forecast. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/ACHV TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_arqt_2026-06-29@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260629 DTEND;VALUE=DATE:20260630 SUMMARY:ARQT PDUFA: ZORYVE (roflumilast) Cream 0.3% DESCRIPTION:Confirmed date. Status: Decided. Outcome: Approved. Across 1\,8 27 FDA decisions since 2020\, the median peak run-up from T-120 was 17.8% and the median move from T-120 to the day before the decision was 1.8%. Pa st behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/ARQT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_lnth_2026-06-29@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260629 DTEND;VALUE=DATE:20260630 SUMMARY:LNTH PDUFA: LNTH-2501 (Gallium-68 edotreotide) DESCRIPTION:Confirmed date. Status: Decided. Outcome: CRL. Across 1\,827 FD A decisions since 2020\, the median peak run-up from T-120 was 17.8% and t he median move from T-120 to the day before the decision was 1.8%. Past be haviour\, not a forecast. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/LNTH TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_uncy_2026-06-29@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260629 DTEND;VALUE=DATE:20260630 SUMMARY:UNCY PDUFA: Oxylanthanum Carbonate (OLC) DESCRIPTION:Confirmed date. Status: Decided. Outcome: CRL. Across 1\,827 FD A decisions since 2020\, the median peak run-up from T-120 was 17.8% and t he median move from T-120 to the day before the decision was 1.8%. Past be haviour\, not a forecast. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/UNCY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_azn_2026-06-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260630 DTEND;VALUE=DATE:20260701 SUMMARY:AZN PDUFA: Truqap - (CAPItello-281) DESCRIPTION:Confirmed date. Status: Decided. Outcome: Approved. Across 1\,8 27 FDA decisions since 2020\, the median peak run-up from T-120 was 17.8% and the median move from T-120 to the day before the decision was 1.8%. Pa st behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/AZN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_ions_2026-06-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260630 DTEND;VALUE=DATE:20260701 SUMMARY:IONS PDUFA: Olezarsen - (CORE) DESCRIPTION:Confirmed date. Status: Decided. Outcome: Approved. Across 1\,8 27 FDA decisions since 2020\, the median peak run-up from T-120 was 17.8% and the median move from T-120 to the day before the decision was 1.8%. Pa st behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/IONS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_vrdn_2026-06-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260630 DTEND;VALUE=DATE:20260701 SUMMARY:VRDN PDUFA: Veligrotug (VRDN-001) - (THRIVE-2) DESCRIPTION:Confirmed date. Status: Decided. Outcome: Approved. Across 1\,8 27 FDA decisions since 2020\, the median peak run-up from T-120 was 17.8% and the median move from T-120 to the day before the decision was 1.8%. Pa st behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/VRDN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_vera_2026-07-07@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260707 DTEND;VALUE=DATE:20260708 SUMMARY:VERA PDUFA: Atacicept - (ORIGIN 3) DESCRIPTION:Confirmed date. Status: Decided. Outcome: Approved. Across 1\,8 27 FDA decisions since 2020\, the median peak run-up from T-120 was 17.8% and the median move from T-120 to the day before the decision was 1.8%. Pa st behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/VERA TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_akba_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~AKBA Readout: Vadadustat DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Rar e disease. Status: Estimated. Primary source: https://clinicaltrials.gov/s tudy/NCT07086755 Source: pdufa.bio. Informational only\, not investment ad vice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_amgn_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~AMGN Readout: Tezepelumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05583227 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/AMGN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_anip_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~ANIP Readout: Yutiq DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05486468 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/ANIP TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ardx_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~ARDX Readout: Tenapanor DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Rar e disease. Status: Estimated. Primary source: https://clinicaltrials.gov/s tudy/NCT06553547 Source: pdufa.bio. Informational only\, not investment ad vice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_axsm_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~AXSM Readout: AXS-14 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: CNS . Status: Estimated. Primary source: https://clinicaltrials.gov/study/NCT0 7523048 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/AXSM TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_calc_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~CALC Readout: CM4620 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Nep hrology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06374797 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cers_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~CERS Readout: S-303 Treated Red Blood Cells DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T03037164 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_crdf_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~CRDF Readout: Onvansertib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT06736717 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_dwtx_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~DWTX Readout: Halneuron DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: CNS . Status: Estimated. Primary source: https://clinicaltrials.gov/study/NCT0 6848348 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_elvn_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~ELVN Readout: ELVN-002 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05650879 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_exel_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~EXEL Readout: Cabozantinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/EXEL TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_howl_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~HOWL Readout: WTX-330 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05479812 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ilmn_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~ILMN Readout: 18F-MFBG DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: CNS . Status: Estimated. Primary source: https://clinicaltrials.gov/study/NCT0 4724369 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_iova_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~IOVA Readout: Lifileucel plus Pembrolizumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06566092 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_jazz_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~JAZZ Readout: Lurbinectedin DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/JAZZ TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ltrn_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~LTRN Readout: Tavocept(BNP7787) in combination with cisplatin DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05933265 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/LTRN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_lxrx_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~LXRX Readout: Sotagliflozin DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Car diovascular. Status: Estimated. Primary source: https://clinicaltrials.gov /study/NCT06481891 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_rare_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~RARE Readout: GTX-102 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Rar e disease. Status: Estimated. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/RARE TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_sion_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~SION Readout: SION-719 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T07108153 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_smmt_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~SMMT Readout: Ivonescimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/SMMT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_sngx_2026-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20260801 SUMMARY:~SNGX Readout: Hypericin DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06470451 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_mrk_2026-07-16@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260716 DTEND;VALUE=DATE:20260717 SUMMARY:MRK PDUFA: Lipfendra (enlicitide decanoate) DESCRIPTION:Confirmed date. Area: Cardiovascular. Status: Decided. Outcome: Approved. Across 1\,827 FDA decisions since 2020\, the median peak run-up from T-120 was 17.8% and the median move from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Primary source: https ://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-pcs k9-inhibitor-lower-ldl-cholesterol-adults-high-cholesterol Source: pdufa.b io. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/MRK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_celc_2026-07-17@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260717 DTEND;VALUE=DATE:20260718 SUMMARY:CELC PDUFA: Gedatolisib with Fulvestrant - (VIKTORIA-1) DESCRIPTION:Confirmed date. Status: Decided. Outcome: Approved. Across 1\,8 27 FDA decisions since 2020\, the median peak run-up from T-120 was 17.8% and the median move from T-120 to the day before the decision was 1.8%. Pa st behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/CELC TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_otsky_2026-07-24@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260724 DTEND;VALUE=DATE:20260725 SUMMARY:OTSKY PDUFA: Centanafadine DESCRIPTION:Confirmed date. Area: CNS/Neurology. Status: Decided. Outcome: Approved. Across 1\,827 FDA decisions since 2020\, the median peak run-up from T-120 was 17.8% and the median move from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Inf ormational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/OTSKY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_mnkd_2026-07-26@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260726 DTEND;VALUE=DATE:20260727 SUMMARY:MNKD PDUFA: FUROSCIX ReadyFlow Autoinjector (SCP-111) DESCRIPTION:Confirmed date. Status: Decided. Outcome: Approved. Across 1\,8 27 FDA decisions since 2020\, the median peak run-up from T-120 was 17.8% and the median move from T-120 to the day before the decision was 1.8%. Pa st behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/MNKD TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:adcomm_capr_2026-07-29@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260729 DTEND;VALUE=DATE:20260730 SUMMARY:CAPR AdComm: Deramiocel (CTGTAC) — DMD DESCRIPTION:Confirmed date. Area: Rare disease. Status: Held. Outcome: 3-9 against. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/adcomm/CAPR-2026-07-29 TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_otlk_2026-07-29@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260729 DTEND;VALUE=DATE:20260730 SUMMARY:OTLK PDUFA: bevacizumab DESCRIPTION:Confirmed date. Status: Decided. Outcome: Approved. Across 1\,8 27 FDA decisions since 2020\, the median peak run-up from T-120 was 17.8% and the median move from T-120 to the day before the decision was 1.8%. Pa st behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/OTLK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:adcomm_repl_2026-07-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260730 DTEND;VALUE=DATE:20260731 SUMMARY:REPL AdComm: RP1 (CTGTAC) — Melanoma DESCRIPTION:Confirmed date. Area: Oncology. Status: Held. Outcome: 10-3 fav orable. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/adcomm/REPL-2026-07-30 TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_vtrs_2026-07-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260730 DTEND;VALUE=DATE:20260731 SUMMARY:VTRS PDUFA: MR-100A-01(Low dose estrogen weekly patch (150 mcg nore lgestromin and 17.5 mcg ethinyl estradiol)) DESCRIPTION:Confirmed date. Status: Decided. Outcome: Approved. Across 1\,8 27 FDA decisions since 2020\, the median peak run-up from T-120 was 17.8% and the median move from T-120 to the day before the decision was 1.8%. Pa st behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/VTRS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_repl_2026-08-02@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260802 DTEND;VALUE=DATE:20260803 SUMMARY:REPL PDUFA: RP1 (vusolimogene oderparepvec) + nivolumab DESCRIPTION:Confirmed date. Area: Oncology. Status: Upcoming. Across 1\,827 FDA decisions since 2020\, the median peak run-up from T-120 was 17.8% an d the median move from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Primary source: https://www.sec.gov/Archives/ edgar/data/0001737953/000110465926088857/tm2621708d1_ex99-1.htm Source: pd ufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/REPL TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_mrna_2026-08-05@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260805 DTEND;VALUE=DATE:20260806 SUMMARY:MRNA PDUFA: mRNA-1010 - (P304) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/MRNA TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_lnth_2026-08-13@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260813 DTEND;VALUE=DATE:20260814 SUMMARY:LNTH PDUFA: MK-6240 DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/LNTH TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_acrs_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~ACRS Readout: A-101 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT07011706 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_akba_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~AKBA Readout: Vadadustat DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Nep hrology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06901505 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_bivi_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~BIVI Readout: NE3107 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06847191 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_bmrn_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~BMRN Readout: Vosoritide DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06455059 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/BMRN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_clrb_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~CLRB Readout: NOV-002 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T03478462 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_eypt_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~EYPT Readout: EYP-1901 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oph thalmology. Status: Estimated. Primary source: https://clinicaltrials.gov/ study/NCT06668064 Source: pdufa.bio. Informational only\, not investment a dvice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_grfs_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~GRFS Readout: ALPHA-1 MP DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T01983241 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_incy_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~INCY Readout: Ruxolitinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06548360 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/INCY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ivvd_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~IVVD Readout: VYD2311 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T07298434 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_jspr_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~JSPR Readout: Briquilimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06736262 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/JSPR TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_kpti_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~KPTI Readout: Selinexor DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05611931 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_kytx_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~KYTX Readout: Standard of Care Treatment DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT05938725 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mane_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~MANE Readout: VDPHL01 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06527365 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mrk_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~MRK Readout: Ensifentrine DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/MRK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_nvo_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~NVO Readout: Semaglutide DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/NVO TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tmo_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~TMO Readout: MK-7240 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06052059 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_vstm_2026-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~VSTM Readout: avutometinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05669482 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/VSTM TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_bmy_2026-08-17@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260817 DTEND;VALUE=DATE:20260818 SUMMARY:BMY PDUFA: iberdomide\, daratumumab\, and dexamethasone vs. daratum umab\, bortezomib\, and dexamethasone - (EXCALIBER RRMM) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/BMY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_capr_2026-08-22@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260822 DTEND;VALUE=DATE:20260823 SUMMARY:CAPR PDUFA: Deramiocel (CAP-1002) - (HOPE-2) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/CAPR TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_rare_2026-08-23@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260823 DTEND;VALUE=DATE:20260824 SUMMARY:RARE PDUFA: DTX401 AAV gene therapy (pariglasgene brecaparvovec) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/RARE TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_jazz_2026-08-25@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260825 DTEND;VALUE=DATE:20260826 SUMMARY:JAZZ PDUFA: Ziihera (zanidatamab-hrii) - (HERIZON-GEA-01) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/JAZZ TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_zyme_2026-08-25@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260825 DTEND;VALUE=DATE:20260826 SUMMARY:ZYME PDUFA: Ziihera (zanidatamab-hrii) - (HERIZON-GEA-01) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/ZYME TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_gild_2026-08-27@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260827 DTEND;VALUE=DATE:20260828 SUMMARY:GILD PDUFA: Bictegravir and Lenacapavir - (ARTISTRY-2) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/GILD TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:conference_esc_2026-08-28@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260828 DTEND;VALUE=DATE:20260829 SUMMARY:ESC Conference: European Society of Cardiology Congress DESCRIPTION:Confirmed date. Area: Cardiology. Status: Scheduled. Source: pd ufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/conference/ESC TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_alzn_2026-08-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~ALZN Readout: AL001 readout DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Status: G uided. Primary source: https://www.sec.gov/Archives/edgar/data/0001677077/ 000121465926008832/az72426110k.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mplt_2026-08-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~MPLT Readout: ML-007C readout DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Status: G uided. Primary source: https://www.sec.gov/Archives/edgar/data/0001770069/ 000119312526224067/mplt-ex99_1.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_regn_2026-08-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260831 DTEND;VALUE=DATE:20260901 SUMMARY:REGN PDUFA: Garetosmab - (OPTIMA) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/REGN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tenx_2026-08-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~TENX Readout: LEVEL-2 readout DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Status: G uided. Primary source: https://www.sec.gov/Archives/edgar/data/0000034956/ 000119312526327455/tennx-20260630.htm Source: pdufa.bio. Informational onl y\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tyra_2026-08-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260801 DTEND;VALUE=DATE:20260901 SUMMARY:~TYRA Readout: SURF303 readout DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Status: G uided. Primary source: https://www.sec.gov/Archives/edgar/data/0001863127/ 000119312526220638/tyra-ex99_1.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_tlx_2026-09-11@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260911 DTEND;VALUE=DATE:20260912 SUMMARY:TLX PDUFA: TLX101-Px DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/TLX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:conference_wclc_2026-09-12@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260912 DTEND;VALUE=DATE:20260913 SUMMARY:WCLC Conference: IASLC World Conference on Lung Cancer DESCRIPTION:Confirmed date. Area: Oncology - lung. Status: Scheduled. Sourc e: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/conference/WCLC TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_agmb_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~AGMB Readout: AGMB-129 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT05843578 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_alec_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~ALEC Readout: AL001 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: CNS . Status: Estimated. Primary source: https://clinicaltrials.gov/study/NCT0 6079190 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_apge_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~APGE Readout: APG777 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06920901 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ardx_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~ARDX Readout: Tenapanor DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Rar e disease. Status: Estimated. Primary source: https://clinicaltrials.gov/s tudy/NCT05643534 Source: pdufa.bio. Informational only\, not investment ad vice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_arqt_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~ARQT Readout: Topical Roflumilast DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/ARQT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_arvn_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~ARVN Readout: ARV-471 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05548127 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/ticker/ARVN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_avir_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~AVIR Readout: Bemnifosbuvir-Ruzasvir DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Inf ectious. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06868264 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_bhvn_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~BHVN Readout: Taldefgrobep Alfa DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Met abolic. Status: Estimated. Primary source: https://clinicaltrials.gov/stud y/NCT07281495 Source: pdufa.bio. Informational only\, not investment advic e. URL:https://www.pdufa.bio/ticker/BHVN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_biib_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~BIIB Readout: Litifilimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/BIIB TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_bmy_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~BMY Readout: Bevacizumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/BMY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cccc_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~CCCC Readout: Cemsidomide DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT04756726 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cgem_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~CGEM Readout: CLN-081 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06381141 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/ticker/CGEM TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cort_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~CORT Readout: Relacorilant DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Inf ectious. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06108219 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/ticker/CORT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_exel_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~EXEL Readout: Cabozantinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/EXEL TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_gild_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~GILD Readout: Sacituzumab Govitecan DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/GILD TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ibrx_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~IBRX Readout: ALT-803 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT02138734 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/ticker/IBRX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ilmn_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~ILMN Readout: 18F-MFBG DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: CNS . Status: Estimated. Primary source: https://clinicaltrials.gov/study/NCT0 7176286 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_immp_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~IMMP Readout: eftilagimod alfa DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T03252938 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_kpti_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~KPTI Readout: Selinexor DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT04562870 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mltx_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~MLTX Readout: Sonelokimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06768671 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mrk_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~MRK Readout: Pembrolizumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/MRK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_sln_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~SLN Readout: SLN124 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05499013 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_supn_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~SUPN Readout: SPN-812 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T02736656 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/SUPN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_vera_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~VERA Readout: Atacicept DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Nep hrology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/VERA TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_vnda_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~VNDA Readout: VSJ-110 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oph thalmology. Status: Estimated. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/VNDA TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_wve_2026-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~WVE Readout: WVE-210201 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06405633 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/WVE TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_nuvl_2026-09-18@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260918 DTEND;VALUE=DATE:20260919 SUMMARY:NUVL PDUFA: Zidesamtinib (NVL-520) - (ARROS-1) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/NUVL TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_rare_2026-09-19@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260919 DTEND;VALUE=DATE:20260920 SUMMARY:RARE PDUFA: UX111 - (ABO-102) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/RARE TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_ions_2026-09-22@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260922 DTEND;VALUE=DATE:20260923 SUMMARY:IONS PDUFA: Zilganersen (ION373) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/IONS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_incy_2026-09-26@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260926 DTEND;VALUE=DATE:20260927 SUMMARY:INCY PDUFA: zilurgisertib DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/INCY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_mirm_2026-09-26@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260926 DTEND;VALUE=DATE:20260927 SUMMARY:MIRM PDUFA: zilurgisertib DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Primary source: https://www.sec.gov/Archives/edgar/data/17594 25/000175942526000036/mirm-20260506xexx991.htm Source: pdufa.bio. Informat ional only\, not investment advice. URL:https://www.pdufa.bio/ticker/MIRM TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_bfri_2026-09-28@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260928 DTEND;VALUE=DATE:20260929 SUMMARY:BFRI PDUFA: Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/BFRI TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:conference_easd_2026-09-28@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260928 DTEND;VALUE=DATE:20260929 SUMMARY:EASD Conference: Eur. Assoc. for the Study of Diabetes DESCRIPTION:Confirmed date. Area: Diabetes / metabolic. Status: Scheduled. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/conference/EASD TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_aard_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~AARD Readout: ARD-101 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001774857/000119312526047757/ck0001774857-ex99_ 2.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_abcl_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~ABCL Readout: ABCL635 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001703057/000170305726000027/a2026q1fybusinessu pdatem.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_alms_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~ALMS Readout: anifrolumab readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001847367/000110465926078507/tm2619143d1_ex99-1 .htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_bolt_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~BOLT Readout: BDC-4182 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001641281/000119312526104102/bolt-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_bsem_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~BSEM Readout: Clinical readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Estimated. Source: pdufa.bio. Informat ional only\, not investment advice. URL:https://www.pdufa.bio/ticker/BSEM TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_dftx_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~DFTX Readout: DT120 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001813814/000110465926077349/tm2618395-2_424b5. htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_evmn_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~EVMN Readout: EVO756 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0002044725/000119312526286918/evmn-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_gpcr_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~GPCR Readout: ACCG-2671 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001888886/000110465926057226/tm2613721d1_ex99-1 .htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_immx_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~IMMX Readout: NXC-201 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001873835/000149315226013663/form8-k.htm Source : pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/IMMX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_iron_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~IRON Readout: DISC-3405 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001816736/000119312526325031/iron-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/IRON TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_kod_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~KOD Readout: KSI-501 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001468748/000119312526211811/kod-ex99_1.htm Sou rce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mbrx_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~MBRX Readout: Annamycin readout DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Status: G uided. Primary source: https://www.sec.gov/Archives/edgar/data/0001659617/ 000143774926025167/ex_995334.htm Source: pdufa.bio. Informational only\, n ot investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mnkd_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~MNKD Readout: MNKD-201 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0000899460/000119312526208910/mnkd-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/MNKD TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_msle_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~MSLE Readout: Clinical readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Estimated. Source: pdufa.bio. Informat ional only\, not investment advice. URL:https://www.pdufa.bio/ticker/MSLE TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ocgn_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~OCGN Readout: OCU400 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001372299/000110465926054866/tm2613474d1_ex99-1 .htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_pfe_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260930 DTEND;VALUE=DATE:20261001 SUMMARY:PFE PDUFA: Brepocitinib (VALOR) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/PFE TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_phvs_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~PHVS Readout: deucrictibant readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001830487/000119312526266666/phvs-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/PHVS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_pmn_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~PMN Readout: PMN310 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001374339/000110465926058967/pmn-20260512xex99d 1.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ppbt_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~PPBT Readout: IM1305 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001614744/000121390026031366/ea028235901ex99-1. htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_ptgx_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260930 DTEND;VALUE=DATE:20261001 SUMMARY:PTGX PDUFA: Rusfertide - (REVIVE) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/PTGX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_roiv_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260930 DTEND;VALUE=DATE:20261001 SUMMARY:ROIV PDUFA: Brepocitinib - (VALOR) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/ROIV TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_roiv_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260901 DTEND;VALUE=DATE:20261001 SUMMARY:~ROIV Readout: brepocitinib readout DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Status: G uided. Primary source: https://www.sec.gov/Archives/edgar/data/0001635088/ 000163508826000061/roiv-20260331.htm Source: pdufa.bio. Informational only \, not investment advice. URL:https://www.pdufa.bio/ticker/ROIV TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_scyx_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~SCYX Readout: SCY-247 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001178253/000117825326000011/scyx-ex10_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_sttk_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~STTK Readout: SL-846 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001680367/000119312526263831/d120796dex993.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_syre_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~SYRE Readout: SPY001 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001636282/000163628226000051/spyre-20260331xexx 991.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_tak_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260930 DTEND;VALUE=DATE:20261001 SUMMARY:TAK PDUFA: Oveporexton (TAK-861-2001) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/TAK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tecx_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~TECX Readout: TX2100 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001681087/000119312526212069/tecx-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_vktx_vanquish2_2026q3@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~VKTX Readout: VANQUISH-2 Phase 3 (VK2735) topline DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Area: Metabolic. Status: Guided. Source: pdufa .bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/vktx TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_vtgn_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~VTGN Readout: fasedienol readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001411685/000162828026043232/vtgn-20260615xex99 1.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_whwk_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~WHWK Readout: HWK-007 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001422142/000119312526210615/whwk-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_xene_2026-09-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20260701 DTEND;VALUE=DATE:20261001 SUMMARY:~XENE Readout: XEN1701 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001582313/000119312526211843/xene-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_mrk_2026-10-10@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261010 DTEND;VALUE=DATE:20261011 SUMMARY:MRK PDUFA: Ifinatamab deruxtecan (I-DXd) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/MRK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_abos_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~ABOS Readout: sabirnetug DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: CNS . Status: Estimated. Primary source: https://clinicaltrials.gov/study/NCT0 6335173 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_annx_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~ANNX Readout: Tanruprubart DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06510816 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_biib_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~BIIB Readout: Litifilimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/BIIB TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cldx_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~CLDX Readout: Barzolvolimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06455202 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/CLDX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cslly_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~CSLLY Readout: Recombinant Single-Chain Factor Viii DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06738485 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/CSLLY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_eypt_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~EYPT Readout: EYP-1901 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oph thalmology. Status: Estimated. Primary source: https://clinicaltrials.gov/ study/NCT06683742 Source: pdufa.bio. Informational only\, not investment a dvice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_huma_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~HUMA Readout: Human Acellular Vessel DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05908084 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_immp_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~IMMP Readout: eftilagimod alfa DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05747794 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_imvt_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~IMVT Readout: IMVT-1402 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06980805 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_inbx_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~INBX Readout: INBRX-106 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T04198766 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/INBX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_incy_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~INCY Readout: Povorcitinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06516952 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/INCY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_jspr_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~JSPR Readout: Briquilimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06162728 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/JSPR TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mrk_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~MRK Readout: Pembrolizumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/MRK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ogn_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~OGN Readout: 150μg CFA (Elonva®) at stimulation day (SD) 1 an DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT05172726 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/ticker/OGN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_pfe_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~PFE Readout: Palbociclib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/PFE TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_rcus_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~RCUS Readout: Zimberelimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT04791839 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_rytm_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~RYTM Readout: Setmelanotide DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Rar e disease. Status: Estimated. Primary source: https://clinicaltrials.gov/s tudy/NCT06772597 Source: pdufa.bio. Informational only\, not investment ad vice. URL:https://www.pdufa.bio/ticker/RYTM TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_sldb_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~SLDB Readout: SGT-003 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Rar e disease. Status: Estimated. Primary source: https://clinicaltrials.gov/s tudy/NCT03368742 Source: pdufa.bio. Informational only\, not investment ad vice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_sny_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~SNY Readout: Venglustat DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T02843035 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/SNY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_srpt_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~SRPT Readout: Eteplirsen DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Rar e disease. Status: Estimated. Primary source: https://clinicaltrials.gov/s tudy/NCT03992430 Source: pdufa.bio. Informational only\, not investment ad vice. URL:https://www.pdufa.bio/ticker/SRPT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_vtrs_2026-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261101 SUMMARY:~VTRS Readout: Cenerimod DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/VTRS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_vtrs_2026-10-17@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261017 DTEND;VALUE=DATE:20261018 SUMMARY:VTRS PDUFA: MR-141 DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/VTRS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:conference_asn_2026-10-21@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261021 DTEND;VALUE=DATE:20261022 SUMMARY:ASN Conference: ASN Kidney Week DESCRIPTION:Confirmed date. Area: Nephrology. Status: Scheduled. Source: pd ufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/conference/ASN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:conference_ectrims_2026-10-21@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261021 DTEND;VALUE=DATE:20261022 SUMMARY:ECTRIMS Conference: Joint ACTRIMS-ECTRIMS (MS Toronto) DESCRIPTION:Confirmed date. Area: Neuro - MS. Status: Scheduled. Source: pd ufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/conference/ECTRIMS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:conference_idweek_2026-10-21@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261021 DTEND;VALUE=DATE:20261022 SUMMARY:IDWEEK Conference: IDSA/SHEA/HIVMA IDWeek DESCRIPTION:Confirmed date. Area: Infectious disease. Status: Scheduled. So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/conference/IDWeek TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:conference_esmo_2026-10-23@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261023 DTEND;VALUE=DATE:20261024 SUMMARY:ESMO Conference: Eur. Society for Medical Oncology Congress DESCRIPTION:Confirmed date. Area: Oncology. Status: Scheduled. Source: pduf a.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/conference/ESMO TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_phar_2026-10-24@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261024 DTEND;VALUE=DATE:20261025 SUMMARY:PHAR PDUFA: Leniolisib DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/PHAR TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_gsk_2026-10-26@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261026 DTEND;VALUE=DATE:20261027 SUMMARY:GSK PDUFA: Bepirovirsen - (B-Well) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/GSK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_ino_2026-10-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261030 DTEND;VALUE=DATE:20261031 SUMMARY:INO PDUFA: INO-3107 DNA immunotherapy DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/INO TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_agio_2026-11-01@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261102 SUMMARY:AGIO PDUFA: Mitapivat (PYRUKYND) - (RISE UP) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/AGIO TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:conference_sitc_2026-11-04@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261104 DTEND;VALUE=DATE:20261105 SUMMARY:SITC Conference: Society for Immunotherapy of Cancer DESCRIPTION:Confirmed date. Area: Immuno-oncology. Status: Scheduled. Sourc e: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/conference/SITC TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:conference_aasld_2026-11-05@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261105 DTEND;VALUE=DATE:20261106 SUMMARY:AASLD Conference: AASLD The Liver Meeting DESCRIPTION:Confirmed date. Area: Hepatology / MASH. Status: Scheduled. Sou rce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/conference/AASLD TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:conference_acr_2026-11-06@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261106 DTEND;VALUE=DATE:20261107 SUMMARY:ACR Conference: ACR Convergence DESCRIPTION:Confirmed date. Area: Rheumatology. Status: Scheduled. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/conference/ACR TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_btai_2026-11-14@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261114 DTEND;VALUE=DATE:20261115 SUMMARY:BTAI PDUFA: IGALMI (dexmedetomidine sublingual film) - (SERENITY At -Home) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/BTAI TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_cytk_2026-11-14@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261114 DTEND;VALUE=DATE:20261115 SUMMARY:CYTK PDUFA: Aficamten - (MAPLE-HCM) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/CYTK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_smmt_2026-11-14@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261114 DTEND;VALUE=DATE:20261115 SUMMARY:SMMT PDUFA: Ivonescimab DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/SMMT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_apge_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~APGE Readout: APG777 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06395948 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_atos_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~ATOS Readout: Z-Endoxifen DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05607004 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_bysi_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~BYSI Readout: Docetaxel + Plinabulin DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT05130827 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cgem_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~CGEM Readout: CLN-081 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05879744 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/CGEM TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_crdf_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~CRDF Readout: Onvansertib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT06106308 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_eltx_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~ELTX Readout: ELI-002 7P DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05726864 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_eras_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~ERAS Readout: Naporafenib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T04866134 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_gild_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~GILD Readout: Sacituzumab Govitecan DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/GILD TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_imux_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~IMUX Readout: IMU-838 tablets DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05134441 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_iova_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~IOVA Readout: Lifileucel plus Pembrolizumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05640193 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_onc_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~ONC Readout: BGB-11417 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/ONC TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_phar_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~PHAR Readout: Leniolisib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/PHAR TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_sny_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~SNY Readout: Rilzabrutinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T07216079 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/SNY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tlx_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~TLX Readout: 177Lu-TLX591 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/TLX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_vir_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~VIR Readout: Bulevirtide DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Inf ectious. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT07142811 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_vxrt_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~VXRT Readout: VXA-COV2-3.3 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06672055 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_zura_2026-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261101 DTEND;VALUE=DATE:20261201 SUMMARY:~ZURA Readout: Tibulizumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06993610 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:conference_ctad_2026-11-16@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261116 DTEND;VALUE=DATE:20261117 SUMMARY:CTAD Conference: Clinical Trials on Alzheimer's Disease DESCRIPTION:Confirmed date. Area: Neuro - Alzheimer's. Status: Scheduled. S ource: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/conference/CTAD TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_svra_2026-11-22@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261122 DTEND;VALUE=DATE:20261123 SUMMARY:SVRA PDUFA: MOLBREEVI (molgramostim inhalation) - (IMPALA-2) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/SVRA TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_bbio_2026-11-27@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261127 DTEND;VALUE=DATE:20261128 SUMMARY:BBIO PDUFA: BBP-418 (ribitol) - (FORTIFY) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/BBIO TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_nuvl_2026-11-27@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261127 DTEND;VALUE=DATE:20261128 SUMMARY:NUVL PDUFA: Neladalkib (NVL-655) - (ALKOVE-1) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/NUVL TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_bayry_2026-11-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261130 DTEND;VALUE=DATE:20261201 SUMMARY:BAYRY PDUFA: Sevabertinib (BAY 2927088) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/BAYRY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_cogt_2026-11-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261130 DTEND;VALUE=DATE:20261201 SUMMARY:COGT PDUFA: Bezuclastinib + sunitinib - (PEAK) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/COGT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_regn_2026-11-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261130 DTEND;VALUE=DATE:20261201 SUMMARY:REGN PDUFA: Cemdisiran + pozelimab (C5 combo) - (NIMBLE) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/REGN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_rhhby_2026-11-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261130 DTEND;VALUE=DATE:20261201 SUMMARY:RHHBY PDUFA: Giredestrant (lidERA) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/RHHBY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_vrtx_2026-11-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261130 DTEND;VALUE=DATE:20261201 SUMMARY:VRTX PDUFA: Povetacicept (ALPN-303) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/VRTX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_exel_2026-12-03@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261203 DTEND;VALUE=DATE:20261204 SUMMARY:EXEL PDUFA: Zanzalintinib (XL092) + atezolizumab - (STELLAR-303) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/EXEL TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:conference_aes_2026-12-04@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261204 DTEND;VALUE=DATE:20261205 SUMMARY:AES Conference: American Epilepsy Society Annual Meeting DESCRIPTION:Confirmed date. Area: Neuro - epilepsy. Status: Scheduled. Sour ce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/conference/AES TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:conference_sabcs_2026-12-08@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261208 DTEND;VALUE=DATE:20261209 SUMMARY:SABCS Conference: San Antonio Breast Cancer Symposium DESCRIPTION:Confirmed date. Area: Oncology - breast. Status: Scheduled. Sou rce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/conference/SABCS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:conference_ash_2026-12-12@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261212 DTEND;VALUE=DATE:20261213 SUMMARY:ASH Conference: American Society of Hematology DESCRIPTION:Confirmed date. Area: Hematology / onc. Status: Scheduled. Sour ce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/conference/ASH TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_vnda_2026-12-12@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261212 DTEND;VALUE=DATE:20261213 SUMMARY:VNDA PDUFA: Imsidolimab DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/VNDA TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_actu_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~ACTU Readout: Losartan DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05077800 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_adct_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~ADCT Readout: Loncastuximab Tesirine DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05971251 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/ticker/ADCT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_agen_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~AGEN Readout: Balstilimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05205330 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_apge_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~APGE Readout: APG777 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT07027527 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_arvn_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~ARVN Readout: ARV-471 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05909397 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/ticker/ARVN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_avir_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~AVIR Readout: Bemnifosbuvir-Ruzasvir DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Inf ectious. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT07037277 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_bcda_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~BCDA Readout: Autologous cell therapy DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Car diovascular. Status: Estimated. Primary source: https://clinicaltrials.gov /study/NCT05925608 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_beam_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~BEAM Readout: BEAM-302 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT05885464 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_biib_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~BIIB Readout: Felzartamab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/BIIB TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_bmy_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~BMY Readout: Nivolumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/BMY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cnta_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~CNTA Readout: cleminorexton DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06752668 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/CNTA TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cort_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~CORT Readout: Relacorilant DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Rar e disease. Status: Estimated. Primary source: https://clinicaltrials.gov/s tudy/NCT03604198 Source: pdufa.bio. Informational only\, not investment ad vice. URL:https://www.pdufa.bio/ticker/CORT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_crdf_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~CRDF Readout: Onvansertib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05383196 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_exel_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~EXEL Readout: Cabozantinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/EXEL TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_goss_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~GOSS Readout: Seralutinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Car diovascular. Status: Estimated. Primary source: https://clinicaltrials.gov /study/NCT06274801 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ino_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~INO Readout: VGX-3100 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/INO TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_insm_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~INSM Readout: Treprostinil Palmitil Inhalation Powder DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Car diovascular. Status: Estimated. Primary source: https://clinicaltrials.gov /study/NCT05649748 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/INSM TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ions_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~IONS Readout: Donidalorsen DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/IONS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ixhl_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~IXHL Readout: IHL-42X Low Dose DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06146101 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_jazz_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~JAZZ Readout: CPX-351 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/JAZZ TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_kpti_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~KPTI Readout: Rituximab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT04442022 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_lxeo_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~LXEO Readout: LX1001 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Car diovascular. Status: Estimated. Primary source: https://clinicaltrials.gov /study/NCT06109181 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mane_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~MANE Readout: VDPHL01 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06972264 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mdgl_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~MDGL Readout: Resmetirom DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05500222 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mnov_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~MNOV Readout: MN-166 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Met abolic. Status: Estimated. Primary source: https://clinicaltrials.gov/stud y/NCT05464784 Source: pdufa.bio. Informational only\, not investment advic e. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mrk_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~MRK Readout: Pembrolizumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/MRK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_nvo_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~NVO Readout: Semaglutide DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/NVO TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_onc_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~ONC Readout: Zanubrutinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/ONC TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_pbyi_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~PBYI Readout: neratinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT03377387 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_pfe_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~PFE Readout: Elranatamab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/PFE TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_phat_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~PHAT Readout: Vonoprazan DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06851559 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_rnac_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~RNAC Readout: Decartes-08 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06038474 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_smmt_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~SMMT Readout: Ivonescimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/SMMT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_sny_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~SNY Readout: Rilzabrutinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06500702 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/SNY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_supn_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~SUPN Readout: BIS-001 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T03474770 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/SUPN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_traw_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~TRAW Readout: rigosertib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Inf ectious. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT07371650 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/ticker/TRAW TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_vir_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~VIR Readout: Tobevibart DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Inf ectious. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06903338 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_vnda_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~VNDA Readout: VQW-765 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/VNDA TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_xncr_2026-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~XNCR Readout: XMAB20717 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05297903 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/ticker/XNCR TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_rhhby_2026-12-18@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261218 DTEND;VALUE=DATE:20261219 SUMMARY:RHHBY PDUFA: Giredestrant (+ everolimus) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/RHHBY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_mlys_2026-12-22@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261222 DTEND;VALUE=DATE:20261223 SUMMARY:MLYS PDUFA: lorundrostat Dose 1 DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/MLYS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_prax_2026-12-27@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261227 DTEND;VALUE=DATE:20261228 SUMMARY:PRAX PDUFA: Relutrigine (PRAX-562) - (EMBOLD) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/PRAX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_cogt_2026-12-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261230 DTEND;VALUE=DATE:20261231 SUMMARY:COGT PDUFA: Bezuclastinib (CGT9486) - (SUMMIT) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/COGT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_abbv_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261231 DTEND;VALUE=DATE:20270101 SUMMARY:ABBV PDUFA: Tavapadon (TEMPO) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/ABBV TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_alny_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~ALNY Readout: elebsiran readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001178670/000162828026007497/alny-20251231.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/ALNY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_atai_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~ATAI Readout: VLS-01 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0002081043/000114036126020708/ef20072731_ex99-1. htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_azn_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261231 DTEND;VALUE=DATE:20270101 SUMMARY:AZN PDUFA: Ultomiris (ravulizumab) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/AZN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_bayry_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261231 DTEND;VALUE=DATE:20270101 SUMMARY:BAYRY PDUFA: KERENDIA (finerenone) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/BAYRY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_bmea_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~BMEA Readout: BMF-650 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001840439/000119312526217037/bmea-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_canf_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~CANF Readout: Clinical readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Estimated. Source: pdufa.bio. Informat ional only\, not investment advice. URL:https://www.pdufa.bio/ticker/CANF TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cmpx_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~CMPX Readout: CTX-10726 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001738021/000117184326003005/exh_991.htm Source : pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/CMPX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cris_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20270101 SUMMARY:~CRIS Readout: NCT07271667 readout DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Status: G uided. Primary source: https://www.sec.gov/Archives/edgar/data/0001108205/ 000110820526000061/cris-20260331.htm Source: pdufa.bio. Informational only \, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_enta_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~ENTA Readout: EDP-978 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001177648/000119312526294828/d17914d424b5.htm S ource: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/ENTA TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ewtx_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~EWTX Readout: Clinical readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Estimated. Source: pdufa.bio. Informat ional only\, not investment advice. URL:https://www.pdufa.bio/ticker/EWTX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_guts_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~GUTS Readout: Clinical readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Estimated. Source: pdufa.bio. Informat ional only\, not investment advice. URL:https://www.pdufa.bio/ticker/GUTS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_help_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~HELP Readout: HLP003 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001833141/000106299326003976/exhibit99-1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ipsc_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~IPSC Readout: CNTY-813 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001850119/000110465926071383/tm2617028d1_ex99-1 .htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_kynb_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~KYNB Readout: FG-3246 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0000921299/000119312526219374/kynb-20260331.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_lona_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~LONA Readout: ATH-1105 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001620463/000119312526211867/lona-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mirm_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~MIRM Readout: AZURE-1 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001759425/000175942526000036/mirm-20260506xexx9 91.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/MIRM TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mtva_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~MTVA Readout: DA-1726 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001638287/000110465926041784/mtva-20260410xex99 d1.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_nvo_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261231 DTEND;VALUE=DATE:20270101 SUMMARY:NVO PDUFA: CagriSema (AM833) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/NVO TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_pcvx_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~PCVX Readout: OPUS-1 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001649094/000164909426000015/pcvx-20260506xexx9 91.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_rapp_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~RAPP Readout: RAP-219 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0002012593/000119312526210324/rapp-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_rgnx_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~RGNX Readout: RGX-314 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001590877/000119312526286825/rgnx-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/RGNX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_skye_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~SKYE Readout: nimacimab readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001516551/000162828026033417/skye-20260331.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_slgl_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~SLGL Readout: SGT-610 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001684693/000117891326002963/exhibit_99-1.htm S ource: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_sls_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~SLS Readout: SLS009 (tambiciclib) Phase 2 AML readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001390478/000139047826000009/sls-202605128xkexh ibit991.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/SLS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_sls_regal_2026q4@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~SLS Readout: REGAL Phase 3 (galinpepimut-S) topline\, event-driven DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Area: Oncology. Status: Guided. Source: pdufa. bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/sls TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_sndx_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~SNDX Readout: SNDX-62122 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001395937/000119312526302608/sndx-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/SNDX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_trax_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~TRAX Readout: ANB033 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0002091349/000119312526224124/trax-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ttrx_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~TTRX Readout: GX-03 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0002023016/000121390026081996/ea029941301ex99-1. htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_zbio_2026-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20270101 SUMMARY:~ZBIO Readout: ZB021 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001953926/000110465926059700/tm2614295d1_ex99-1 .htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_nuvb_2027-01-04@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270104 DTEND;VALUE=DATE:20270105 SUMMARY:NUVB PDUFA: IBTROZI (taletrectinib) sNDA DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/NUVB TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_ibrx_2027-01-06@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270106 DTEND;VALUE=DATE:20270107 SUMMARY:IBRX PDUFA: ANKTIVA (N-803) + BCG DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/IBRX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_aplm_2027-01-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270201 SUMMARY:~APLM Readout: Uproleselan DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT04743505 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_bmy_2027-01-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270201 SUMMARY:~BMY Readout: Nivolumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/BMY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cadl_2027-01-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270201 SUMMARY:~CADL Readout: Aglatimagene Besadenovec DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T03152318 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_elvn_2027-01-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270201 SUMMARY:~ELVN Readout: ELVN-002 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT06328738 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_exel_2027-01-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270201 SUMMARY:~EXEL Readout: Cabozantinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/EXEL TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_gild_2027-01-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270201 SUMMARY:~GILD Readout: MK-3475 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/GILD TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_idya_2027-01-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270201 SUMMARY:~IDYA Readout: Darovasertib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05987332 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_nuvl_2027-01-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270201 SUMMARY:~NUVL Readout: Neladalkib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/NUVL TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_rare_2027-01-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270201 SUMMARY:~RARE Readout: Setrusumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/RARE TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_regn_2027-01-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270201 SUMMARY:~REGN Readout: Odronextamab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/REGN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_siga_2027-01-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270201 SUMMARY:~SIGA Readout: Tecovirimat Oral Capsule DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T04957485 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_prax_2027-01-29@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270129 DTEND;VALUE=DATE:20270130 SUMMARY:PRAX PDUFA: ulixacaltamide DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/PRAX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_gild_2027-02-02@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270202 DTEND;VALUE=DATE:20270203 SUMMARY:GILD PDUFA: Yeztugo (lenacapavir) once-weekly oral DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/GILD TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_azn_2027-02-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270201 DTEND;VALUE=DATE:20270301 SUMMARY:~AZN Readout: R-Chop DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/AZN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_kytx_2027-02-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270201 DTEND;VALUE=DATE:20270301 SUMMARY:~KYTX Readout: Standard of Care Treatment DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06152172 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mltx_2027-02-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270201 DTEND;VALUE=DATE:20270301 SUMMARY:~MLTX Readout: Sonelokimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06641076 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mrk_2027-02-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270201 DTEND;VALUE=DATE:20270301 SUMMARY:~MRK Readout: Pembrolizumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/MRK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_arqt_2027-02-23@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270223 DTEND;VALUE=DATE:20270224 SUMMARY:ARQT PDUFA: ZORYVE (roflumilast) cream 0.05% DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/ARQT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_cgem_2027-02-27@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270227 DTEND;VALUE=DATE:20270228 SUMMARY:CGEM PDUFA: CLN-081 DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/CGEM TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_agio_2027-03-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270301 DTEND;VALUE=DATE:20270401 SUMMARY:~AGIO Readout: Mitapivat DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T04278781 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/AGIO TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cldx_2027-03-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270301 DTEND;VALUE=DATE:20270401 SUMMARY:~CLDX Readout: Barzolvolimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T03688178 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/CLDX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cogt_2027-03-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270301 DTEND;VALUE=DATE:20270401 SUMMARY:~COGT Readout: CGT9486 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Inf ectious. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/COGT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_dnli_2027-03-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270301 DTEND;VALUE=DATE:20270401 SUMMARY:~DNLI Readout: BIIB122 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: CNS . Status: Estimated. Primary source: https://clinicaltrials.gov/study/NCT0 6602193 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/DNLI TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_gild_2027-03-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270301 DTEND;VALUE=DATE:20270401 SUMMARY:~GILD Readout: Sacituzumab Govitecan DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/GILD TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ions_2027-03-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270301 DTEND;VALUE=DATE:20270401 SUMMARY:~IONS Readout: Olezarsen DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/IONS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ipha_2027-03-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270301 DTEND;VALUE=DATE:20270401 SUMMARY:~IPHA Readout: Monalizumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05143970 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mdgl_2027-03-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270301 DTEND;VALUE=DATE:20270401 SUMMARY:~MDGL Readout: Resmetirom DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T04951219 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_nuvb_2027-03-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270301 DTEND;VALUE=DATE:20270401 SUMMARY:~NUVB Readout: safusidenib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06334432 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/NUVB TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_onc_2027-03-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270301 DTEND;VALUE=DATE:20270401 SUMMARY:~ONC Readout: Zanubrutinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/ONC TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tsha_2027-03-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270301 DTEND;VALUE=DATE:20270401 SUMMARY:~TSHA Readout: TSHA-101 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T04798235 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_akts_2027-03-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270401 SUMMARY:~AKTS Readout: AKY-1189 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0002035832/000119312526216716/ck0002035832-ex99_ 1.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_crbp_2027-03-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270401 SUMMARY:~CRBP Readout: CRB-701 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001595097/000119312526219707/crbp-20260331.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_nmra_2027-03-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270401 SUMMARY:~NMRA Readout: NMRA-511 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001885522/000119312526210310/nmra-ex99_1.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ocul_2027-03-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270401 SUMMARY:~OCUL Readout: HELIOS-3 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001393434/000110465926055256/ocul-20260331x10q. htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_qncx_2027-03-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270401 SUMMARY:~QNCX Readout: LAM-001 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001662774/000119312526324786/d163930dex994.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_inbx_2027-04-14@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270414 DTEND;VALUE=DATE:20270415 SUMMARY:INBX PDUFA: INBRX-106 DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/INBX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_aim_2027-04-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270501 SUMMARY:~AIM Readout: Ampligen DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T03899987 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cgtx_2027-04-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270501 SUMMARY:~CGTX Readout: Dextromethorphan-Bupropion DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: CNS . Status: Estimated. Primary source: https://clinicaltrials.gov/study/NCT0 5531656 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cldx_2027-04-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270501 SUMMARY:~CLDX Readout: Barzolvolimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05349890 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/CLDX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_idya_2027-04-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270501 SUMMARY:~IDYA Readout: Darovasertib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05907954 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_iova_2027-04-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270501 SUMMARY:~IOVA Readout: Lifileucel plus Pembrolizumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T03449108 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_kpti_2027-04-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270501 SUMMARY:~KPTI Readout: Selinexor DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT02343042 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_kytx_2027-04-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270501 SUMMARY:~KYTX Readout: Standard of Care Treatment DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06384976 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mnov_2027-04-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270501 SUMMARY:~MNOV Readout: MN-166 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T04057898 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_nbtx_2027-04-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270501 SUMMARY:~NBTX Readout: NBTXR3 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T03589339 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_nvs_2027-04-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270501 SUMMARY:~NVS Readout: Iptacopan DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/NVS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_regn_2027-04-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270501 SUMMARY:~REGN Readout: Cemiplimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/REGN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_smmt_2027-04-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270501 SUMMARY:~SMMT Readout: Ivonescimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/SMMT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tlx_2027-04-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270501 SUMMARY:~TLX Readout: 177Lu-TLX591 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/TLX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_phvs_2027-04-23@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270423 DTEND;VALUE=DATE:20270424 SUMMARY:PHVS PDUFA: Deucrictibant IR - (RAPIDe-3) DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/pdufa/PHVS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_axsm_2027-05-01@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270501 DTEND;VALUE=DATE:20270502 SUMMARY:AXSM PDUFA: AXS-12 DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Primary source: https://www.sec.gov/Archives/edgar/data/15794 28/000119312526304039/axsm-ex99_1.htm Source: pdufa.bio. Informational onl y\, not investment advice. URL:https://www.pdufa.bio/ticker/AXSM TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:pdufa_bbio_2027-05-08@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270508 DTEND;VALUE=DATE:20270509 SUMMARY:BBIO PDUFA: Encaleret DESCRIPTION:Confirmed date. Status: Upcoming. Across 1\,827 FDA decisions s ince 2020\, the median peak run-up from T-120 was 17.8% and the median mov e from T-120 to the day before the decision was 1.8%. Past behaviour\, not a forecast. Primary source: https://www.sec.gov/Archives/edgar/data/17438 81/000114036126029291/ef20078442_ex99-1.htm Source: pdufa.bio. Information al only\, not investment advice. URL:https://www.pdufa.bio/ticker/BBIO TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_biib_2027-05-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270501 DTEND;VALUE=DATE:20270601 SUMMARY:~BIIB Readout: Felzartamab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Nep hrology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/BIIB TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_fdmt_2027-05-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270501 DTEND;VALUE=DATE:20270601 SUMMARY:~FDMT Readout: 4D-150 IVT DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T04483440 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mbx_2027-05-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270501 DTEND;VALUE=DATE:20270601 SUMMARY:~MBX Readout: MBX 2109 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06531941 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_regn_2027-05-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270501 DTEND;VALUE=DATE:20270601 SUMMARY:~REGN Readout: Cemiplimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/REGN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tngx_2027-05-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270501 DTEND;VALUE=DATE:20270601 SUMMARY:~TNGX Readout: S095035 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06188702 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_vygr_2027-05-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270501 DTEND;VALUE=DATE:20270601 SUMMARY:~VYGR Readout: VY7523 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: CNS . Status: Estimated. Primary source: https://clinicaltrials.gov/study/NCT0 6874621 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_avln_2027-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270601 DTEND;VALUE=DATE:20270701 SUMMARY:~AVLN Readout: AP01 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06329401 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_blte_2027-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270601 DTEND;VALUE=DATE:20270701 SUMMARY:~BLTE Readout: Tinlarebant DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05949593 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_fdmt_2027-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270601 DTEND;VALUE=DATE:20270701 SUMMARY:~FDMT Readout: 4D-150 IVT DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oph thalmology. Status: Estimated. Primary source: https://clinicaltrials.gov/ study/NCT06864988 Source: pdufa.bio. Informational only\, not investment a dvice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_fth_2027-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270601 DTEND;VALUE=DATE:20270701 SUMMARY:~FTH Readout: SNS-101 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05864144 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_immp_2027-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270601 DTEND;VALUE=DATE:20270701 SUMMARY:~IMMP Readout: eftilagimod alfa DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT06726265 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_indp_2027-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270601 DTEND;VALUE=DATE:20270701 SUMMARY:~INDP Readout: Decoy20 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05651022 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ions_2027-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270601 DTEND;VALUE=DATE:20270701 SUMMARY:~IONS Readout: Olezarsen DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Rar e disease. Status: Estimated. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/IONS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_jazz_2027-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270601 DTEND;VALUE=DATE:20270701 SUMMARY:~JAZZ Readout: CPX-351 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Hem atology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/JAZZ TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_kymr_2027-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270601 DTEND;VALUE=DATE:20270701 SUMMARY:~KYMR Readout: KT-621 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT07217015 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_kytx_2027-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270601 DTEND;VALUE=DATE:20270701 SUMMARY:~KYTX Readout: Standard of Care Treatment DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06475495 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_lnth_2027-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270601 DTEND;VALUE=DATE:20270701 SUMMARY:~LNTH Readout: PI-2620 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: CNS . Status: Estimated. Source: pdufa.bio. Informational only\, not investmen t advice. URL:https://www.pdufa.bio/pdufa/LNTH TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_nvs_2027-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270601 DTEND;VALUE=DATE:20270701 SUMMARY:~NVS Readout: Remibrutinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/NVS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_smmt_2027-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270601 DTEND;VALUE=DATE:20270701 SUMMARY:~SMMT Readout: Ivonescimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/SMMT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_svra_2027-06-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270601 DTEND;VALUE=DATE:20270701 SUMMARY:~SVRA Readout: Molgramostim DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/SVRA TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_prok_2027-06-30@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270701 SUMMARY:~PROK Readout: REGEN-006 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001850270/000119312526225848/prok-ex99_2.htm So urce: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_amgn_2027-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270701 DTEND;VALUE=DATE:20270801 SUMMARY:~AMGN Readout: ABP 938 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oph thalmology. Status: Estimated. Primary source: https://clinicaltrials.gov/ study/NCT07614776 Source: pdufa.bio. Informational only\, not investment a dvice. URL:https://www.pdufa.bio/ticker/AMGN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_btai_2027-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270701 DTEND;VALUE=DATE:20270801 SUMMARY:~BTAI Readout: Sublingual film containing dexmedetomidine DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: CNS . Status: Estimated. Source: pdufa.bio. Informational only\, not investmen t advice. URL:https://www.pdufa.bio/pdufa/BTAI TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_meso_2027-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270701 DTEND;VALUE=DATE:20270801 SUMMARY:~MESO Readout: Rexlemestrocel-L DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06325566 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_oncy_2027-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270701 DTEND;VALUE=DATE:20270801 SUMMARY:~ONCY Readout: REOLYSIN DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT07280377 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/ticker/ONCY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tlx_2027-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270701 DTEND;VALUE=DATE:20270801 SUMMARY:~TLX Readout: 177Lu-TLX591 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/TLX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_vktx_2027-07-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270701 DTEND;VALUE=DATE:20270801 SUMMARY:~VKTX Readout: VK2735 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Met abolic. Status: Estimated. Primary source: https://clinicaltrials.gov/stud y/NCT07104500 Source: pdufa.bio. Informational only\, not investment advic e. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_artv_2027-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270801 DTEND;VALUE=DATE:20270901 SUMMARY:~ARTV Readout: AB-101 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06265220 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_asnd_2027-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270801 DTEND;VALUE=DATE:20270901 SUMMARY:~ASND Readout: TransCon CNP DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05081609 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/ASND TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ions_2027-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270801 DTEND;VALUE=DATE:20270901 SUMMARY:~IONS Readout: ION582 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Rar e disease. Status: Estimated. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/IONS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_nvcr_2027-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270801 DTEND;VALUE=DATE:20270901 SUMMARY:~NVCR Readout: Temozolomide DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05764954 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/NVCR TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_rare_2027-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270801 DTEND;VALUE=DATE:20270901 SUMMARY:~RARE Readout: Triheptanoin DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/RARE TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_smmt_2027-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270801 DTEND;VALUE=DATE:20270901 SUMMARY:~SMMT Readout: Ivonescimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/SMMT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tlx_2027-08-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270801 DTEND;VALUE=DATE:20270901 SUMMARY:~TLX Readout: 177Lu-TLX591 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/TLX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_agen_2027-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20271001 SUMMARY:~AGEN Readout: Botensilimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05608044 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_bhvn_2027-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20271001 SUMMARY:~BHVN Readout: BHV-1300 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06980649 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/BHVN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_chrs_2027-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20271001 SUMMARY:~CHRS Readout: CHS-1420 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Inf ectious. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06679985 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/ticker/CHRS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cnta_2027-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20271001 SUMMARY:~CNTA Readout: cleminorexton DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T07598708 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/CNTA TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_cstl_2027-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20271001 SUMMARY:~CSTL Readout: FCX-007 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06892639 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_huma_2027-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20271001 SUMMARY:~HUMA Readout: Human Acellular Vessel DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T03005418 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_imvt_2027-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20271001 SUMMARY:~IMVT Readout: IMVT-1402 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT06754462 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_incy_2027-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20271001 SUMMARY:~INCY Readout: Corticosteroids DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06585774 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/INCY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_iva_2027-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20271001 SUMMARY:~IVA Readout: IVA337 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Inf ectious. Status: Estimated. Primary source: https://clinicaltrials.gov/stu dy/NCT04849728 Source: pdufa.bio. Informational only\, not investment advi ce. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_maia_2027-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20271001 SUMMARY:~MAIA Readout: 6-Thio-2'-Deoxyguanosine DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05208944 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_smmt_2027-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20271001 SUMMARY:~SMMT Readout: Ivonescimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/SMMT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tlsi_2027-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20271001 SUMMARY:~TLSI Readout: Pembrolizumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05607953 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_upb_2027-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20271001 SUMMARY:~UPB Readout: Verekitug DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06966479 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_vnda_2027-09-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20271001 SUMMARY:~VNDA Readout: Tradipitant DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/VNDA TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_lly_2027-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271001 DTEND;VALUE=DATE:20271101 SUMMARY:~LLY Readout: Tirzepatide DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Met abolic. Status: Estimated. Source: pdufa.bio. Informational only\, not inv estment advice. URL:https://www.pdufa.bio/pdufa/LLY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mrk_2027-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271001 DTEND;VALUE=DATE:20271101 SUMMARY:~MRK Readout: MK-8527 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Inf ectious. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/MRK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ogn_2027-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271001 DTEND;VALUE=DATE:20271101 SUMMARY:~OGN Readout: 150μg CFA (Elonva®) at stimulation day (SD) 1 an DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05504720 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/OGN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_onc_2027-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271001 DTEND;VALUE=DATE:20271101 SUMMARY:~ONC Readout: Zanubrutinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Nep hrology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/ONC TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tars_2027-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271001 DTEND;VALUE=DATE:20271101 SUMMARY:~TARS Readout: TP-03 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T07562087 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tlx_2027-10-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271001 DTEND;VALUE=DATE:20271101 SUMMARY:~TLX Readout: 177Lu-TLX591 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/TLX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_arvn_2027-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271101 DTEND;VALUE=DATE:20271201 SUMMARY:~ARVN Readout: ARV-471 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T07023731 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/ARVN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_crnx_2027-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271101 DTEND;VALUE=DATE:20271201 SUMMARY:~CRNX Readout: Atumelnant DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06712823 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/CRNX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_mygn_2027-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271101 DTEND;VALUE=DATE:20271201 SUMMARY:~MYGN Readout: Niraparib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T05642780 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_onc_2027-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271101 DTEND;VALUE=DATE:20271201 SUMMARY:~ONC Readout: BGB-3111 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/ONC TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_regn_2027-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271101 DTEND;VALUE=DATE:20271201 SUMMARY:~REGN Readout: Cemdisiran DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oph thalmology. Status: Estimated. Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/pdufa/REGN TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_vera_2027-11-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271101 DTEND;VALUE=DATE:20271201 SUMMARY:~VERA Readout: Atacicept DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/VERA TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_adag_2027-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271201 DTEND;VALUE=DATE:20280101 SUMMARY:~ADAG Readout: ADG106 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05275777 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_anvs_2027-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271201 DTEND;VALUE=DATE:20280101 SUMMARY:~ANVS Readout: buntanetap/posiphen DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: CNS . Status: Estimated. Primary source: https://clinicaltrials.gov/study/NCT0 6709014 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_goss_2027-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271201 DTEND;VALUE=DATE:20280101 SUMMARY:~GOSS Readout: Seralutinib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Car diovascular. Status: Estimated. Primary source: https://clinicaltrials.gov /study/NCT04816604 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_ints_2027-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271201 DTEND;VALUE=DATE:20280101 SUMMARY:~INTS Readout: INT230-6 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Primary source: https://clinicaltrials.gov/study/NC T06263231 Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/ticker/INTS TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_legn_2027-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271201 DTEND;VALUE=DATE:20280101 SUMMARY:~LEGN Readout: LCAR-B38M CAR-T Cell DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Primary source: https://clinicaltrials.gov/study /NCT05539430 Source: pdufa.bio. Informational only\, not investment advice . URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_lly_2027-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271201 DTEND;VALUE=DATE:20280101 SUMMARY:~LLY Readout: Mirikizumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Imm unology. Status: Estimated. Source: pdufa.bio. Informational only\, not in vestment advice. URL:https://www.pdufa.bio/pdufa/LLY TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_nuvl_2027-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271201 DTEND;VALUE=DATE:20280101 SUMMARY:~NUVL Readout: Neladalkib DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/NUVL TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_otlk_2027-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271201 DTEND;VALUE=DATE:20280101 SUMMARY:~OTLK Readout: bevacizumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oph thalmology. Status: Estimated. Primary source: https://clinicaltrials.gov/ study/NCT05112861 Source: pdufa.bio. Informational only\, not investment a dvice. URL:https://www.pdufa.bio/ticker/OTLK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_rare_2027-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271201 DTEND;VALUE=DATE:20280101 SUMMARY:~RARE Readout: Triheptanoin DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/RARE TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_smmt_2027-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271201 DTEND;VALUE=DATE:20280101 SUMMARY:~SMMT Readout: Ivonescimab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/SMMT TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tak_2027-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271201 DTEND;VALUE=DATE:20280101 SUMMARY:~TAK Readout: Tislelizumab DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Oth er. Status: Estimated. Source: pdufa.bio. Informational only\, not investm ent advice. URL:https://www.pdufa.bio/pdufa/TAK TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_tlx_2027-12-15@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271201 DTEND;VALUE=DATE:20280101 SUMMARY:~TLX Readout: 177Lu-TLX591 DESCRIPTION:Company guidance or FDA action window is known to the month onl y\; this entry spans the whole month rather than claiming a day. Area: Onc ology. Status: Estimated. Source: pdufa.bio. Informational only\, not inve stment advice. URL:https://www.pdufa.bio/pdufa/TLX TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:readout_klrs_2027-12-31@pdufa.bio DTSTAMP:20260804T033748Z DTSTART;VALUE=DATE:20271001 DTEND;VALUE=DATE:20280101 SUMMARY:~KLRS Readout: TH103 readout DESCRIPTION:Guidance is to the quarter only\; this entry spans the quarter rather than claiming a day. Status: Guided. Primary source: https://www.se c.gov/Archives/edgar/data/0001754068/000119312526306737/d125006dex992.htm Source: pdufa.bio. Informational only\, not investment advice. URL:https://www.pdufa.bio/readouts TRANSP:TRANSPARENT END:VEVENT END:VCALENDAR