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PDUFA Dates October 2027

Updated November 6, 2026

These dates are public. The filterable calendar, alerts, exports and AI research are in the app — free account: the next 7 days and 3 companies you track. Plans →

No PDUFA date is tracked for October 2027 yet. Each row shows the drug, company, indication, status and how firm the date is.

105
Total Catalysts
0
PDUFA Dates
105
Trial Results
61
Companies

Week 1Sep 27 - Oct 3(16 catalysts)

  • Q4 2027~QAZNGC012F (AZD0120) Phase 2 Est. Readout
  • Q4 2027~QDSKYFTrastuzumab Deruxtecan Phase 3 Est. Readout
  • Q4 2027~QAZNTremelimumab Phase 2 Est. Readout
  • Q4 2027~QNMADLB-100 Phase 2 Est. Readout
  • Q4 2027~QNVSDYP688 Phase 2 Est. Readout
  • Q4 2027~QAZNOsimertinib Phase 2 Est. Readout (OSTARA)
  • Q4 2027~QDSKYFTrastuzumab deruxtecan Phase 2 Est. Readout (ANISE)
  • Q4 2027~QRHHBYGlofitamab Phase 3 Est. Readout
  • Q4 2027~QPFEibuzatrelvir Phase 3 Est. Readout
  • Q4 2027~QBNN.DEMethylphenidate (MPH) Phase 2 Est. Readout (PRIME)
  • Q4 2027~QAZNAZD0120 Phase 2 Est. Readout (DURGA-1)
  • Q4 2027~QBAYRYGnRH Agonist Phase 2 Est. Readout
  • Q4 2027~QAZNAmivantamab Phase 2 Est. Readout
  • Q4 2027~QTXMDRhu-pGSN Phase 2 Est. Readout
  • Q4 2027~QAZNDatopotamab deruxtecan (Dato-DXd) Phase 2 Est. Readout
  • Q4 2027~QMRKPembrolizumab Phase 2 Est. Readout

Week 2Oct 4 - Oct 10(4 catalysts)

  • Q4 2027~QNVOUBT251 Phase 2 Est. Readout
  • Q4 2027~QNVOSemaglutide Phase 2 Est. Readout
  • Q4 2027~QBNN.DENabiximols Phase 2 Est. Readout (ARISTOCRAT)
  • Q4 2027~QARGXEmpasiprubart IV Phase 3 Est. Readout (emnergize)

Week 3Oct 11 - Oct 17(47 catalysts)

  • Q4 2027~QAZNTarperprumig Phase 2 Est. Readout
  • Q4 2027~QABBVVenetoclax Phase 2 Est. Readout
  • Q4 2027~QAZNALXN2030 Phase 2 Est. Readout (CONCORD)
  • Q4 2027~QMRKMK-7262 Phase 2 Est. Readout
  • Q4 2027~QPFEPF-08653944 Phase 3 Est. Readout
  • Q4 2027~QSNYSAR446597 Phase 2 Est. Readout
  • Q4 2027~QITCIITI-1284 Phase 2 Est. Readout
  • Oct 2027~PHARKL1333 Phase 2 Est. Readout (FALCON)
  • Q4 2027~QIPN.PAIV ICT01 Phase 2 Est. Readout (EVICTION)
  • Oct 2027~JHPCYSHR-A1811 Injection Phase 3 Est. Readout
  • Oct 2027~ABBVVenetoclax Phase 2 Est. Readout
  • Oct 2027~SNYcarmustine, etoposide, cytarabine, melphalan Phase 2 Est. Readout
  • Oct 2027~BMYNivolumab Phase 2 Est. Readout
  • Oct 2027~RHHBYAtezolizumab Phase 2 Est. Readout (CAPTIV-8)
  • Oct 2027~JHPCYHRS-4508+ Capecitabine Phase 2 Est. Readout
  • Oct 2027~TXMDvoretigene neparvovec-rzyl Phase 2 Est. Readout
  • Oct 2027~IBOSenaparib Phase 2 Est. Readout
  • Oct 2027~MIRMMRM-3379 Phase 2 Est. Readout
  • Oct 2027~EVMNEVO756, Dose 1 Phase 2 Est. Readout
  • Oct 2027~OPKCTAP101 Phase 2 Est. Readout
  • Oct 2027~ALPMYEnzalutamide Phase 2 Est. Readout
  • Oct 2027~SYRESPY072 Phase 2 Est. Readout
  • Oct 2027~UPBVerekitug Phase 2 Est. Readout
  • Q4 2027~QAZNPuxitatug Samrotecan Phase 3 Est. Readout
  • Oct 2027~ORKAORKA-002 Phase 2 Est. Readout
  • Oct 2027~TARSTP-05 (lotilaner) Low Dose Phase 2 Est. Readout
  • Oct 2027~ICLRSP-420 Phase 2 Est. Readout
  • Oct 2027~CORTMifepristone Phase 2 Est. Readout
  • Oct 2027~LLYTirzepatide Phase 3 Est. Readout
  • Oct 2027~AGENEvofosfamide Phase 2 Est. Readout
  • Oct 2027~RHHBYDendritic cell vaccination Phase 2 Est. Readout
  • Oct 2027~ARGXEmpasiprubart IV Phase 2 Est. Readout (ADAPT Forward2)
  • Oct 2027~ONCZanubrutinib Phase 3 Est. Readout (ALMOND)
  • Oct 2027~GMABEpcoritamab Phase 2 Est. Readout
  • Oct 2027~NBIXNBI-1117568 Phase 3 Est. Readout
  • Oct 2027~EYPTEYP-1901 Phase 3 Est. Readout (DME)
  • Oct 2027~LLYImlunestrant Phase 3 Est. Readout (EMBER-4)
  • Oct 2027~ARGXefgartigimod PH20 SC Phase 3 Est. Readout (ADVANCE SC+)
  • Oct 2027~GLUEOral MRT-2359 Phase 2 Est. Readout (MODeFIRe-1)
  • Oct 2027~CLYMbudoprutug Phase 2 Est. Readout (PrisMN)
  • Oct 2027~PALIPALI-2108 Phase 2 Est. Readout (ASCENTRA-UC)
  • Q4 2027~QARWRARO-INHBE Phase 2 Est. Readout
  • Oct 2027~ICLRPRX-102 Phase 3 Est. Readout (RISE)
  • Oct 2027~UPR.IRNanvuranlat Phase 3 Est. Readout (Beacon-BTC)
  • Oct 2027~VERUEnobosarm Phase 2 Est. Readout (PLATEAU)
  • Oct 2027~DSKYFEnhertu Phase 2 Est. Readout (CaRPET)
  • Q4 2027~QIMCRBrenetafusp Phase 3 Est. Readout (PRISM-MEL-301)

Week 4Oct 18 - Oct 24(9 catalysts)

  • Q4 2027~QNVSIptacopan Phase 3 Est. Readout
  • Q4 2027~QPFEPF-08634404 Phase 2 Est. Readout
  • Q4 2027~QMRKMK-8527 Phase 3 Est. Readout
  • Q4 2027~QBHCplecanatide Phase 2 Est. Readout (Trulance)
  • Q4 2027~QNVSCTL019 Phase 2 Est. Readout
  • Q4 2027~QPHATVonoprazan Phase 3 Est. Readout
  • Q4 2027~QAMGNAMG 510 Phase 2 Est. Readout
  • Q4 2027~QMRKpembrolizumab Phase 2 Est. Readout
  • Q4 2027~QSNYPCV21 vaccine Phase 3 Est. Readout

Week 5Oct 25 - Oct 31(29 catalysts)

  • Q4 2027~QPFEDisitamab vedotin Phase 2 Est. Readout
  • Q4 2027~QMRKMK-8690 Phase 2 Est. Readout
  • Q4 2027~QTAKRusfertide Phase 2 Est. Readout
  • Q4 2027~QSNYDupilumab Phase 3 Est. Readout
  • Q4 2027~QMRKpembrolizumab Phase 3 Est. Readout
  • Q4 2027~QGALDYNemolizumab Phase 3 Est. Readout
  • Q4 2027~QBAYRYSevabertinib Phase 3 Est. Readout (SOHO-02)
  • Q4 2027~QGSKDepemokimab Phase 3 Est. Readout (DESTINY)
  • Q4 2027~QSOPHAlleance® Phase 3 Est. Readout
  • Q4 2027~QTAKIxazomib Phase 2 Est. Readout
  • Q4 2027~QVECTApraglutide Phase 3 Est. Readout (STARS extend)
  • Q4 2027~QJHPCYSHR3680 Phase 3 Est. Readout
  • Q4 2027~QPBYIAlisertib Phase 2 Est. Readout (ALISCA-Lung1)
  • Q4 2027~QALPMYRoxadustat Phase 3 Est. Readout
  • Q4 2027~QTLX177Lu girentuximab Phase 2 Est. Readout
  • Q4 2027~QONCSubcutaneous Tislelizumab Phase 3 Est. Readout
  • Q4 2027~QBLCORifaximin SSD IR Phase 2 Est. Readout (RIDE)
  • Q4 2027~QPFEBrentuximab vedotin Phase 2 Est. Readout
  • Q4 2027~QACADPimavanserin Tartrate Phase 2 Est. Readout
  • Q4 2027~QBIIBTyruko Injectable Product Phase 2 Est. Readout (AttackMS)
  • Q4 2027~QIPSEYIPN10200 Phase 2 Est. Readout (MERANTI)
  • Q4 2027~QINCYRuxolitinib Phase 2 Est. Readout
  • Q4 2027~QALPMYMethylprednisolone Phase 2 Est. Readout
  • Q4 2027~QIVBXFIBI362 Phase 3 Est. Readout
  • Q4 2027~QAMGNPanitumumab Phase 2 Est. Readout
  • Q4 2027~QLXRXSotagliflozin Phase 2 Est. Readout (SOPHIST)
  • Q4 2027~QINCYAxatilimab Phase 2 Est. Readout
  • Q4 2027~QBGNEidarubicin/daunorubicin Phase 2 Est. Readout
  • Q4 2027~QIPN.PACorabotase Phase 2 Est. Readout (MERANTI)
September 2027Full CalendarNovember 2027

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PDUFA dates October 2027: questions

How many FDA decisions (PDUFA dates) are in October 2027?
No PDUFA date is tracked for October 2027 as of November 6, 2026.
What is a PDUFA date?
The FDA's target date to complete its review of a new drug (NDA) or biologic (BLA) application. On or before it, the FDA approves the application, issues a complete response letter (CRL), or extends the review.

About PDUFA Dates in October 2027

This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for October 2027. PDUFA dates represent FDA's target action dates for reviewing new drug applications (NDAs) and biologics license applications (BLAs).

Biotech investors and traders closely monitor these dates as FDA decisions can significantly impact stock prices. Our calendar includes PDUFA dates, clinical trial results, advisory committee meetings, and other regulatory milestones.

Learn more about PDUFA dates or view the full biotech catalyst calendar.