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All 208 biotech and pharma companies covered by pdufa.bio, with each company's next FDA catalyst and the number of FDA decisions we hold on record for it. Every calendar date and outcome on this site is sourced to a primary FDA, SEC or company filing. Free, no login.

Companies tracked
208
With an upcoming catalyst
87
With decision history
194
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A

AAPG1 decision on recordABBVAbbViePDUFA 2026-12-31 · Tavapadon (TEMPO) · 13 decisions on recordABEO2 decisions on recordACAD1 decision on recordACHVAchieve Life Sciences Inc.2 decisions on recordADCTReadout 2026-12-15 · Loncastuximab Tesirine · 1 decision on recordADMA1 decision on recordAGIOAgios PharmaceuticalsPDUFA 2026-11-01 · Mitapivat (PYRUKYND) - (RISE UP) · 2 decisions on recordALC1 decision on recordALDX2 decisions on recordALLO1 decision on recordALNY2 decisions on recordALPMY3 decisions on recordALVO2 decisions on recordALXO2 decisions on recordAMGNReadout 2027-07-15 · ABP 938 · 5 decisions on recordAMPH3 decisions on recordAMRN1 decision on recordAMRX11 decisions on recordANABno catalyst on recordANIK1 decision on recordANIP3 decisions on recordANTE1 decision on recordAPLS1 decision on recordAPTO1 decision on recordAQST1 decision on recordARGX2 decisions on recordARQTArcutis Biotherapeutics Inc.Readout 2026-09-15 · Topical Roflumilast · 4 decisions on recordARVNReadout 2026-09-15 · ARV-471 · 1 decision on recordARWR1 decision on recordASNDReadout 2027-08-15 · TransCon CNP · 3 decisions on recordATRA2 decisions on recordAURA1 decision on recordAUTL1 decision on recordAVBP1 decision on recordAXGN1 decision on recordAXSMAxsome Therapeutics, Inc.PDUFA 2027-05-01 · AXS-12 · 3 decisions on recordAZNAstraZeneca PLCPDUFA 2026-12-31 · Ultomiris (ravulizumab) · 16 decisions on record

B

BAYRYBayerPDUFA 2026-11-30 · Sevabertinib (BAY 2927088) · 3 decisions on recordBBIOBridgeBio PharmaPDUFA 2026-11-27 · BBP-418 (ribitol) - (FORTIFY)BCAB1 decision on recordBCRX1 decision on recordBCTX1 decision on recordBFRIBiofrontera Inc.PDUFA 2026-09-28 · Ameluz (aminolevulinic acid hydrochloridBHVNReadout 2026-09-15 · Taldefgrobep Alfa · 1 decision on recordBIIBReadout 2026-09-15 · Litifilimab · 5 decisions on recordBMRNReadout 2026-08-15 · Vosoritide · 1 decision on recordBMYBristol-Myers Squibb CompanyPDUFA 2026-08-17 · iberdomide, daratumumab, and dexamethaso · 9 decisions on recordBNTX1 decision on recordBTAIBioXcel TherapeuticsPDUFA 2026-11-14 · IGALMI (dexmedetomidine sublingual film)

C

CAPRCapricor Therapeutics Inc.PDUFA 2026-08-22 · Deramiocel (CAP-1002) - (HOPE-2) · 1 decision on recordCASI1 decision on recordCELCCelcuity Inc.1 decision on recordCGEMCullinan Therapeutics, Inc.Readout 2026-09-15 · CLN-081 · 1 decision on recordCGON1 decision on recordCHRSReadout 2027-09-15 · CHS-1420 · 1 decision on recordCING2 decisions on recordCLDI1 decision on recordCLDXReadout 2026-10-15 · Barzolvolimab · 1 decision on recordCLLS2 decisions on recordCMND1 decision on recordCMPXReadout 2026-12-15 · CTX-009 · 1 decision on recordCNTAReadout 2026-12-15 · cleminorexton · 1 decision on recordCOCP1 decision on recordCOGTCogent BiosciencesPDUFA 2026-11-30 · Bezuclastinib + sunitinib - (PEAK)CORTCORCEPT THERAPEUTICS INCReadout 2026-09-15 · Relacorilant · 2 decisions on recordCRNXReadout 2027-11-15 · Atumelnant · 1 decision on recordCRSP1 decision on recordCSLLYReadout 2026-10-15 · Recombinant Single-Chain Factor Viii · 1 decision on recordCUE1 decision on recordCYTKCYTOKINETICS INCPDUFA 2026-11-14 · Aficamten - (MAPLE-HCM) · 2 decisions on record

D

DNLIReadout 2027-03-15 · BIIB122 · 1 decision on recordDSNKY3 decisions on record

E

EBS2 decisions on recordENGN1 decision on recordENTA1 decision on recordEQ2 decisions on recordESLA1 decision on recordETON2 decisions on recordEXELExelixisReadout 2026-09-15 · Cabozantinib · 2 decisions on record

F

FBIO2 decisions on record

G

GHRS1 decision on recordGILDGilead Sciences Inc.PDUFA 2026-08-27 · Bictegravir and Lenacapavir - (ARTISTRY- · 5 decisions on recordGKOS2 decisions on recordGLPG2 decisions on recordGLSI2 decisions on recordGMAB4 decisions on recordGRCE1 decision on recordGSKGSK plc American Depositary Shares (Each repPDUFA 2026-10-26 · Bepirovirsen - (B-Well) · 10 decisions on record

H

HALO2 decisions on recordHOTH1 decision on recordHRMY2 decisions on record

I

IBRXImmunityBio, Inc.Readout 2026-09-15 · ALT-803 · 4 decisions on recordIMMX2 decisions on recordINBXInhibrx Biosciences, Inc.Readout 2026-10-15 · INBRX-106 · 1 decision on recordINCYINCYTE CORPReadout 2026-08-15 · Ruxolitinib · 7 decisions on recordINDV1 decision on recordINOInovio PharmaceuticalsPDUFA 2026-10-30 · INO-3107 DNA immunotherapyINSMReadout 2026-12-15 · Treprostinil Palmitil Inhalation Powder · 1 decision on recordINTE1 decision on recordINTSReadout 2027-12-15 · INT230-6 · 1 decision on recordINVA2 decisions on recordIONI1 decision on recordIONSIonis Pharmaceuticals Inc.PDUFA 2026-09-22 · Zilganersen (ION373) · 4 decisions on recordIPSEY1 decision on recordIRDno catalyst on recordIRONReadout 2026-09-15 · DISC-1459 · 3 decisions on recordIRWD2 decisions on record

J

JAGX1 decision on recordJANX1 decision on recordJAZZJazz Pharmaceuticals plcPDUFA 2026-08-25 · Ziihera (zanidatamab-hrii) - (HERIZON-GE · 2 decisions on recordJNJ17 decisions on recordJSPRReadout 2026-08-15 · Briquilimab · 3 decisions on record

K

KALV1 decision on recordKRYS1 decision on recordKURA1 decision on recordKZIA2 decisions on record

L

LENZ1 decision on recordLEXX1 decision on recordLGND3 decisions on recordLLYReadout 2027-10-15 · Tirzepatide · 6 decisions on recordLNTHLantheus Holdings Inc.PDUFA 2026-08-13 · MK-6240 · 3 decisions on recordLQDA1 decision on recordLSTA1 decision on recordLTRN1 decision on recordLYEL2 decisions on record

M

MGNX1 decision on recordMIRMMirum Pharmaceuticals, Inc.Readout 2026-08-15 · Brelovitug · 2 decisions on recordMIST2 decisions on recordMLYSMineralys Therapeutics, Inc.PDUFA 2026-12-22 · lorundrostat Dose 1MNKDMannKind CorporationReadout 2027-03-15 · Afrezza · 2 decisions on recordMRKMerck & Co.Readout 2026-08-15 · Ensifentrine · 15 decisions on recordMRKR1 decision on recordMRNAModerna Inc.PDUFA 2026-08-05 · mRNA-1010 - (P304) · 3 decisions on record

N

NRIX2 decisions on recordNUVBNuvation Bio Inc.PDUFA 2027-01-04 · IBTROZI (taletrectinib) sNDA · 1 decision on recordNUVLNuvalent Inc.PDUFA 2026-09-18 · Zidesamtinib (NVL-520) - (ARROS-1)NVAX2 decisions on recordNVCRReadout 2027-08-15 · Temozolomide · 1 decision on recordNVONovo NordiskReadout 2026-08-15 · Semaglutide · 7 decisions on recordNVSReadout 2027-04-15 · Iptacopan · 8 decisions on record

O

OGEN1 decision on recordOGNReadout 2026-10-15 · 150μg CFA (Elonva®) at stimulation day ( · 1 decision on recordOMER1 decision on recordONCReadout 2026-11-15 · BGB-11417 · 2 decisions on recordONCYReadout 2027-07-15 · REOLYSIN · 1 decision on recordOTLKOutlook Therapeutics, Inc.Readout 2027-12-15 · bevacizumab · 5 decisions on record

P

PBM1 decision on recordPFERoivant/PriovantPDUFA 2026-09-30 · Brepocitinib (VALOR) · 9 decisions on recordPGEN2 decisions on recordPHARPharming Group N.V.PDUFA 2026-10-24 · Leniolisib · 1 decision on recordPHIO4 decisions on recordPHRRF1 decision on recordPHVSPharvaris N.V.Readout 2026-08-15 · deucrictibantPLRX1 decision on recordPRAXPraxis Precision Medicines Inc.PDUFA 2026-12-27 · Relutrigine (PRAX-562) - (EMBOLD)PRTA1 decision on recordPRTC1 decision on recordPTCT2 decisions on recordPTGXProtagonist Therapeutics Inc.PDUFA 2026-09-30 · Rusfertide - (REVIVE) · 1 decision on record

R

RAREUltragenyx Pharmaceutical Inc.PDUFA 2026-08-23 · DTX401 AAV gene therapy (pariglasgene br · 1 decision on recordRCKT1 decision on recordREGNRegeneron Pharmaceuticals Inc.PDUFA 2026-08-31 · Garetosmab - (OPTIMA) · 13 decisions on recordREPLReplimune Group, Inc.PDUFA 2026-08-02 · RP1 (vusolimogene oderparepvec) + nivolu · 2 decisions on recordRGNXReadout 2026-08-15 · Ranibizumab · 2 decisions on recordRHHBYRoche/GenentechPDUFA 2026-11-30 · Giredestrant (lidERA) · 10 decisions on recordRNAZ2 decisions on recordROIVRoivant Sciences Ltd.PDUFA 2026-09-30 · Brepocitinib - (VALOR)RPRX1 decision on recordRYTMReadout 2026-10-15 · Setmelanotide · 1 decision on record

S

SLNO1 decision on recordSLS1 decision on recordSMMTSummit Therapeutics Inc.PDUFA 2026-11-14 · IvonescimabSNDXReadout 2026-09-15 · Revumenib · 2 decisions on recordSNSE1 decision on recordSNYReadout 2026-10-15 · Venglustat · 7 decisions on recordSPROSpero Therapeutics Inc.1 decision on recordSPRY2 decisions on recordSRPTReadout 2026-10-15 · Eteplirsen · 1 decision on recordSRRK1 decision on recordSUPNReadout 2026-09-15 · SPN-812 · 1 decision on recordSVRASavaraPDUFA 2026-11-22 · MOLBREEVI (molgramostim inhalation) - (I · 1 decision on recordSWTX1 decision on record

T

TAKTakeda Pharmaceutical Company Limited AmericPDUFA 2026-09-30 · Oveporexton (TAK-861-2001) · 2 decisions on recordTARA2 decisions on recordTEVA5 decisions on recordTLXTelix Pharmaceuticals LimitedPDUFA 2026-09-11 · TLX101-Px · 2 decisions on recordTNXP1 decision on recordTRAWReadout 2026-12-15 · rigosertib · 1 decision on recordTURN1 decision on recordTVTX2 decisions on record

U

UNCYUnicycive Therapeutics Inc.3 decisions on recordURGN2 decisions on record

V

VALN1 decision on recordVERAVera Therapeutics Inc.Readout 2026-09-15 · Atacicept · 1 decision on recordVNDAVanda Pharmaceuticals Inc.Readout 2026-09-15 · VSJ-110 · 3 decisions on recordVRDNViridian Therapeutics Inc.1 decision on recordVRTXVertexPDUFA 2026-11-30 · Povetacicept (ALPN-303) · 1 decision on recordVSTMReadout 2026-08-15 · avutometinib · 1 decision on recordVTRSViatris Inc.Readout 2026-10-15 · Cenerimod · 1 decision on record

W

WVEReadout 2026-09-15 · WVE-210201 · 1 decision on record

X

XERS1 decision on recordXNCRReadout 2026-12-15 · XMAB20717 · 1 decision on recordXOMA1 decision on recordXRTX1 decision on record

Z

ZLAB1 decision on recordZVRA1 decision on recordZYMEZymeworks Inc.PDUFA 2026-08-25 · Ziihera (zanidatamab-hrii) - (HERIZON-GE

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