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Biotech catalyst screener
Every FDA catalyst in one filterable view, PDUFA decisions, clinical-trial readouts, medical conferences, and FDA advisory committee meetings. Filter by ticker, event type, therapeutic area, and date.
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Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.
© 2026 pdufa.bio. All rights reserved.
| Ticker | Date | Type | Drug | Area |
|---|---|---|---|---|
| REPL | 2026-08-02 | PDUFA | RP1 (vusolimogene oderparepvec) + nivolumab | Oncology |
| MRNA | 2026-08-05 | PDUFA | mRNA-1010 - (P304) | |
| LNTH | 2026-08-13 | PDUFA | MK-6240 | |
| BMRN | 2026-08-15 (est.) | Readout | Vosoritide | Other |
| INCY | 2026-08-15 (est.) | Readout | Ruxolitinib | Other |
| JSPR | 2026-08-15 (est.) | Readout | Briquilimab | Other |
| MIRM | 2026-08-15 (est.) | Readout | Brelovitug | Infectious |
| MRK | 2026-08-15 (est.) | Readout | Ensifentrine | Other |
| NVO | 2026-08-15 (est.) | Readout | Semaglutide | Other |
| PHVS | 2026-08-15 (est.) | Readout | deucrictibant | Other |
| RGNX | 2026-08-15 (est.) | Readout | Ranibizumab | Ophthalmology |
| VSTM | 2026-08-15 (est.) | Readout | avutometinib | Other |
| BMY | 2026-08-17 | PDUFA | iberdomide, daratumumab, and dexamethasone vs. darat | |
| CAPR | 2026-08-22 | PDUFA | Deramiocel (CAP-1002) - (HOPE-2) | |
| RARE | 2026-08-23 | PDUFA | DTX401 AAV gene therapy (pariglasgene brecaparvovec) | |
| JAZZ | 2026-08-25 | PDUFA | Ziihera (zanidatamab-hrii) - (HERIZON-GEA-01) | |
| ZYME | 2026-08-25 | PDUFA | Ziihera (zanidatamab-hrii) - (HERIZON-GEA-01) | |
| GILD | 2026-08-27 | PDUFA | Bictegravir and Lenacapavir - (ARTISTRY-2) | |
| REGN | 2026-08-31 | PDUFA | Garetosmab - (OPTIMA) | |
| TLX | 2026-09-11 | PDUFA | TLX101-Px | |
| ARQT | 2026-09-15 (est.) | Readout | Topical Roflumilast | Other |
| ARVN | 2026-09-15 (est.) | Readout | ARV-471 | Oncology |
| BHVN | 2026-09-15 (est.) | Readout | Taldefgrobep Alfa | Metabolic |
| BIIB | 2026-09-15 (est.) | Readout | Litifilimab | Immunology |
| BMY | 2026-09-15 (est.) | Readout | Bevacizumab | Other |
| CGEM | 2026-09-15 (est.) | Readout | CLN-081 | Hematology |
| CORT | 2026-09-15 (est.) | Readout | Relacorilant | Infectious |
| EXEL | 2026-09-15 (est.) | Readout | Cabozantinib | Other |
| GILD | 2026-09-15 (est.) | Readout | Sacituzumab Govitecan | Oncology |
| IBRX | 2026-09-15 (est.) | Readout | ALT-803 | Oncology |
| IRON | 2026-09-15 (est.) | Readout | DISC-1459 | Other |
| MRK | 2026-09-15 (est.) | Readout | Pembrolizumab | Oncology |
| SNDX | 2026-09-15 (est.) | Readout | Revumenib | Other |
| SUPN | 2026-09-15 (est.) | Readout | SPN-812 | Other |
| VERA | 2026-09-15 (est.) | Readout | Atacicept | Nephrology |
| VNDA | 2026-09-15 (est.) | Readout | VSJ-110 | Ophthalmology |
| WVE | 2026-09-15 (est.) | Readout | WVE-210201 | Other |
| NUVL | 2026-09-18 | PDUFA | Zidesamtinib (NVL-520) - (ARROS-1) | |
| RARE | 2026-09-19 | PDUFA | UX111 - (ABO-102) | |
| IONS | 2026-09-22 | PDUFA | Zilganersen (ION373) | |
| INCY | 2026-09-26 | PDUFA | zilurgisertib | |
| MIRM | 2026-09-26 | PDUFA | zilurgisertib | |
| BFRI | 2026-09-28 | PDUFA | Ameluz (aminolevulinic acid hydrochloride) topical g | |
| PFE | 2026-09-30 | PDUFA | Brepocitinib (VALOR) | |
| PTGX | 2026-09-30 | PDUFA | Rusfertide - (REVIVE) | |
| ROIV | 2026-09-30 | PDUFA | Brepocitinib - (VALOR) | |
| TAK | 2026-09-30 | PDUFA | Oveporexton (TAK-861-2001) | |
| MRK | 2026-10-10 | PDUFA | Ifinatamab deruxtecan (I-DXd) | |
| BIIB | 2026-10-15 (est.) | Readout | Litifilimab | Immunology |
| CLDX | 2026-10-15 (est.) | Readout | Barzolvolimab | Other |
| CSLLY | 2026-10-15 (est.) | Readout | Recombinant Single-Chain Factor Viii | Other |
| INBX | 2026-10-15 (est.) | Readout | INBRX-106 | Other |
| INCY | 2026-10-15 (est.) | Readout | Povorcitinib | Other |
| JSPR | 2026-10-15 (est.) | Readout | Briquilimab | Other |
| MIRM | 2026-10-15 (est.) | Readout | Maralixibat | Other |
| MRK | 2026-10-15 (est.) | Readout | Pembrolizumab | Oncology |
| OGN | 2026-10-15 (est.) | Readout | 150μg CFA (Elonva®) at stimulation day (SD) 1 an | Immunology |
| PFE | 2026-10-15 (est.) | Readout | Palbociclib | Other |
| RYTM | 2026-10-15 (est.) | Readout | Setmelanotide | Rare disease |
| SNY | 2026-10-15 (est.) | Readout | Venglustat | Other |
| SRPT | 2026-10-15 (est.) | Readout | Eteplirsen | Rare disease |
| VTRS | 2026-10-15 (est.) | Readout | Cenerimod | Immunology |
| VTRS | 2026-10-17 | PDUFA | MR-141 | |
| PHAR | 2026-10-24 | PDUFA | Leniolisib | |
| GSK | 2026-10-26 | PDUFA | Bepirovirsen - (B-Well) | |
| INO | 2026-10-30 | PDUFA | INO-3107 DNA immunotherapy | |
| AGIO | 2026-11-01 | PDUFA | Mitapivat (PYRUKYND) - (RISE UP) | |
| BTAI | 2026-11-14 | PDUFA | IGALMI (dexmedetomidine sublingual film) - (SERENITY | |
| CYTK | 2026-11-14 | PDUFA | Aficamten - (MAPLE-HCM) | |
| SMMT | 2026-11-14 | PDUFA | Ivonescimab | |
| CGEM | 2026-11-15 (est.) | Readout | CLN-081 | Other |
| GILD | 2026-11-15 (est.) | Readout | Sacituzumab Govitecan | Other |
| ONC | 2026-11-15 (est.) | Readout | BGB-11417 | Hematology |
| PHAR | 2026-11-15 (est.) | Readout | Leniolisib | Other |
| SNY | 2026-11-15 (est.) | Readout | Rilzabrutinib | Other |
| TLX | 2026-11-15 (est.) | Readout | 177Lu-TLX591 | Other |
| SVRA | 2026-11-22 | PDUFA | MOLBREEVI (molgramostim inhalation) - (IMPALA-2) | |
| BBIO | 2026-11-27 | PDUFA | BBP-418 (ribitol) - (FORTIFY) | |
| NUVL | 2026-11-27 | PDUFA | Neladalkib (NVL-655) - (ALKOVE-1) | |
| BAYRY | 2026-11-30 | PDUFA | Sevabertinib (BAY 2927088) | |
| COGT | 2026-11-30 | PDUFA | Bezuclastinib + sunitinib - (PEAK) | |
| REGN | 2026-11-30 | PDUFA | Cemdisiran + pozelimab (C5 combo) - (NIMBLE) | |
| RHHBY | 2026-11-30 | PDUFA | Giredestrant (lidERA) | |
| VRTX | 2026-11-30 | PDUFA | Povetacicept (ALPN-303) | |
| EXEL | 2026-12-03 | PDUFA | Zanzalintinib (XL092) + atezolizumab - (STELLAR-303) | |
| VNDA | 2026-12-12 | PDUFA | Imsidolimab | |
| ADCT | 2026-12-15 (est.) | Readout | Loncastuximab Tesirine | Oncology |
| ARVN | 2026-12-15 (est.) | Readout | ARV-471 | Oncology |
| BIIB | 2026-12-15 (est.) | Readout | Felzartamab | Other |
| BMY | 2026-12-15 (est.) | Readout | Nivolumab | Oncology |
| CMPX | 2026-12-15 (est.) | Readout | CTX-009 | Oncology |
| CNTA | 2026-12-15 (est.) | Readout | cleminorexton | Other |
| CORT | 2026-12-15 (est.) | Readout | Relacorilant | Rare disease |
| EXEL | 2026-12-15 (est.) | Readout | Cabozantinib | Other |
| INO | 2026-12-15 (est.) | Readout | VGX-3100 | Other |
| INSM | 2026-12-15 (est.) | Readout | Treprostinil Palmitil Inhalation Powder | Cardiovascular |
| IONS | 2026-12-15 (est.) | Readout | Donidalorsen | Other |
| JAZZ | 2026-12-15 (est.) | Readout | CPX-351 | Hematology |
| MRK | 2026-12-15 (est.) | Readout | Pembrolizumab | Oncology |
| NVO | 2026-12-15 (est.) | Readout | Semaglutide | Other |
| ONC | 2026-12-15 (est.) | Readout | Zanubrutinib | Other |
| PFE | 2026-12-15 (est.) | Readout | Elranatamab | Hematology |
| RGNX | 2026-12-15 (est.) | Readout | Ranibizumab | Other |
| SMMT | 2026-12-15 (est.) | Readout | Ivonescimab | Oncology |
| SNDX | 2026-12-15 (est.) | Readout | Revumenib | Hematology |
| SNY | 2026-12-15 (est.) | Readout | Rilzabrutinib | Other |
| SUPN | 2026-12-15 (est.) | Readout | BIS-001 | Other |
| TRAW | 2026-12-15 (est.) | Readout | rigosertib | Infectious |
| VNDA | 2026-12-15 (est.) | Readout | VQW-765 | Other |
| XNCR | 2026-12-15 (est.) | Readout | XMAB20717 | Oncology |
| RHHBY | 2026-12-18 | PDUFA | Giredestrant (+ everolimus) | |
| MLYS | 2026-12-22 | PDUFA | lorundrostat Dose 1 | |
| PRAX | 2026-12-27 | PDUFA | Relutrigine (PRAX-562) - (EMBOLD) | |
| COGT | 2026-12-30 | PDUFA | Bezuclastinib (CGT9486) - (SUMMIT) | |
| ABBV | 2026-12-31 | PDUFA | Tavapadon (TEMPO) | |
| AZN | 2026-12-31 | PDUFA | Ultomiris (ravulizumab) | |
| BAYRY | 2026-12-31 | PDUFA | KERENDIA (finerenone) | |
| NVO | 2026-12-31 | PDUFA | CagriSema (AM833) | |
| NUVB | 2027-01-04 | PDUFA | IBTROZI (taletrectinib) sNDA | |
| IBRX | 2027-01-06 | PDUFA | ANKTIVA (N-803) + BCG |