213
Total Catalysts
4
PDUFA Dates
90
Trial Results
160
Companies
Week 1Sep 7 - Sep 13(40 catalysts)
- Sep 2026~NVOCagriSema (Cagrilintide B and Semaglutide I) Phase 3 Est. Readout
- Sep 8INBXPhase 2 — INBRX-106
- Sep 8TEVJFTEVJF — Stock Offering (424B5)
- Sep 8ROIVPhase 2 — mosliciguat
- Sep 9KNSAConference
- Sep 9ANIXConference
- Sep 9JAZZConference
- Sep 9NNOXNNOX Earnings Report
- Sep 9ETONConference
- Sep 9RNTXConference
- Sep 9TYRATYRA-300 Phase 2 Est. Readout
- Sep 9ANIXANIX Earnings Report
- Sep 9IMUXConference
- Sep 9RGENConference
- Sep 9MRKAcquisition
- Sep 9CMPSData Readout - COMP360
- Sep 9SCNISCNI Earnings Report
- Sep 9REGNREGN ALERT: Hagens Berman Alerts Regeneron Pharmaceuticals, Inc. (REGN) Investors to Pending Securities Fraud Class Action Amid Disclosures About Key Trial's Protocol and Ultimate Failure
- Sep 9TYRAData Readout — Dabogratinib
- Sep 10ENGNENGN Earnings Report
- Sep 10NHPAPNational M&A / Acquisition
- Sep 10KMTSKMTS Earnings Report
- Sep 2026~IRONDISC-3405 Phase 2 Est. Readout
- Sep 10TEVAStock Offering — $4.9 billion
- Sep 2026~PHM.MCPlitidepsin 1.5 mg/day Phase 2 Est. Readout
- Sep 2026~SNYItepekimab (SAR440340) Phase 3 Est. Readout
- Sep 10YARWStock Offering
- Sep 11KRSAKorsana Reports Financial Results
- Sep 11RHHBYAcquisition — Verona Pharma ($1.1B)
- Sep 2026~TXMDBrepocitinib PO QD Phase 3 Est. Readout
- Sep 11ADCTConference
- Sep 2026~PCYCIbrutinib Phase 2 Est. Readout
- Sep 13EIKNConference
- Sep 2026~GILDSacituzumab Govitecan-hziy Phase 3 Est. Readout
- Sep 13GEHCAcquisition ($1B)
- Sep 13BTAIAcquisition — Teva Pharmaceutical Industries ($125M)
- Sep 13TEVAAcquisition — BioXcel ($125M)
Week 2Sep 14 - Sep 20(79 catalysts)
- Sep 14FVNNUII M&A / Acquisition
- Sep 14RNXTConference — RenovoCath®
- Sep 14KMTSKESTRA Reports Financial Results
- Sep 14BIVIBIVI — Stock Offering (424B5)
- Sep 14SPTXSPTX Earnings Report
- Sep 14DMAARDrugs M&A / Acquisition
- Sep 14TYRAStock Offering — $400 Million
- Sep 2026~SNYFitusiran Phase 3 Est. Readout
- Sep 14CRBPData Readout — CRB-913
- Sep 14ELTXConference
- Sep 14BNRBNR Earnings Report
- Sep 2026~HPHA.DEnilotinib Phase 2 Est. Readout
- Sep 2026~SUPNSPN-812 Phase 3 Est. Readout
- Sep 2026~GALDYnemolizumab Phase 2 Est. Readout
- Sep 2026~NVSEFTOUR006 - 20 MG Phase 2 Est. Readout
- Sep 2026~ARQTTopical roflumilast 0.3% foam Phase 2 Est. Readout
- Sep 2026~CYTKCK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg) Phase 2 Est. Readout
- Sep 2026~TXMDDPI-386 Nasal Gel Phase 2 Est. Readout
- Sep 2026~HLUYYLu AG13909 Phase 2 Est. Readout
- Sep 2026~BGNESX-682 Phase 2 Est. Readout
- Sep 2026~TEVJFTEV-53408 Phase 2 Est. Readout
- Sep 2026~GTHXTrilaciclib Phase 2 Est. Readout
- Sep 2026~BAYRYBAY2599023 (DTX201) Phase 2 Est. Readout
- Sep 2026~SKBBYPRT-064040 nasal spray Phase 2 Est. Readout
- Sep 2026~SVASinovac PCV24 Phase 2 Est. Readout
- Sep 2026~WVEWVE-006 Phase 2 Est. Readout
- Sep 2026~GNMSFVincristine Phase 2 Est. Readout
- Sep 2026~LLYLY3650150 Phase 3 Est. Readout
- Sep 2026~ITCILumateperone Phase 3 Est. Readout
- Sep 2026~VNDATrichostatin A Phase 2 Est. Readout
- Sep 2026~VERAAtacicept Phase 2 Est. Readout
- Sep 2026~SLNSLN124 Phase 2 Est. Readout
- Sep 2026~GILDTAF Phase 2 Est. Readout
- Sep 2026~ALKSOlanzapine Phase 3 Est. Readout
- Sep 2026~PFEMET233 and MET097 Phase 2 Est. Readout
- Sep 2026~IRONDISC-1459 Phase 3 Est. Readout
- Sep 2026~ARGXIVIG (Intravenous Immunoglobulin) Phase 3 Est. Readout
- Sep 2026~ABBVAdalimumab Phase 3 Est. Readout
- Sep 2026~MRKCarboplatin Phase 3 Est. Readout
- Sep 2026~MGNXlorigerlimab Phase 2 Est. Readout
- Sep 2026~TEVATEV-53408 Phase 2 Est. Readout
- Sep 2026~MRKPembrolizumab Phase 2 Est. Readout
- Sep 2026~NAMSObicetrapib 10mg Phase 2 Est. Readout
- Sep 2026~MAZEMZE829 Phase 2 Est. Readout
- Sep 2026~PCSAPCS6422 and capecitabine Phase 2 Est. Readout
- Sep 2026~EWTXSevasemten 10 mg Phase 2 Est. Readout
- Sep 2026~BNN.DENabiximols Phase 2 Est. Readout
- Sep 2026~ORICORIC-114 Phase 2 Est. Readout
- Sep 2026~AZNCFTezepelumab Phase 2 Est. Readout
- Sep 15PCSAAcquisition ($200M)
- Sep 15ABBVConference
- Sep 15HSCSHeartSciences Reports Financial Results
- Sep 2026~AVIRBemnifosbuvir-Ruzasvir (BEM/RZR) Phase 3 Est. Readout
- Sep 15CGTXConference — zervimesine
- Sep 2026~BHVNTaldefgrobep Alfa Phase 2 Est. Readout
- Sep 15AMGNConference
- Sep 16ODTXODTX Earnings Report
- Sep 16NNDMNNDM Earnings Report
- Sep 16HALOStock Offering — $1.05 billion
- Sep 16GILDAcquisition
- Sep 16NVSAcquisition ($125M)
- Sep 16ASMBConference
- Sep 16MNKDAcquisition
- Sep 17POAIAxe M&A / Acquisition
- Sep 2026~VRTXBiological/Vaccine Phase 3 Est. Readout
- Sep 2026~RHHBYOcrelizumab Test Formulation Phase 2 Est. Readout
- Sep 17IPHAIPHA Earnings Report
- Sep 17CLDWWCLDWW — Stock Offering (424B5)
- Sep 18NVOAcquisition
- Sep 2026~MRKNemtabrutinib Phase 2 Est. Readout
- Sep 2026~BAYRYemodepside Phase 2 Est. Readout
- Sep 18BLSMBlossomHill Reports Financial Results
- Sep 18NSRXNSRX — Stock Offering (424B5)
- Sep 20CGENPhase 1 — MAIA-Ovarian
Week 3Sep 21 - Sep 27(44 catalysts)
- Sep 21ABVXABVX Earnings Report
- Sep 21PTCTAcquisition — Sangamo Therapeutics, Inc.
- Sep 21TLPPFAcquisition
- Sep 21HYFTHYFT Earnings Report
- Sep 2026~BEIGFSonrotoclax Phase 2 Est. Readout
- Sep 22JNJAcquisition — Intra-Cellular Therapies ($14.6B)
- Sep 22LNTHAcquisition
- Sep 22NKGNConference — troculeucel
- Sep 22ITCIAcquisition — Johnson & Johnson ($14.6B)
- Sep 22BMEAStock Offering
- Sep 22AYTUAYTU Reports Financial Results
- Sep 22BKHABlack Corporate Update
- Sep 2026~MRNAmRNA-1403 Phase 2 Est. Readout
- Sep 23KLTOKLTO — Stock Offering (424B5)
- Sep 23GBIOConference
- Sep 2026~AZNCFAcalabrutinib Phase 2 Est. Readout
- Sep 2026~PFEPF-07220060 Phase 3 Est. Readout
- Sep 2026~PFEPF-07220060 Phase 2 Est. Readout
- Sep 23TECHAcquisition — Merck KGaA
- Sep 23MKKGYAcquisition — Bio-Techne Corporation
- Sep 24RZLTRezolute, Reports Financial Results
- Sep 2026~NVSEFYTB323 Phase 2 Est. Readout
- Sep 2026~IVBXFIBI362 Phase 2 Est. Readout
- Sep 24JAGXJAGX — Stock Offering (424B5)
- Sep 24MRKAcquisition ($1.3B)
- Sep 24MOLNData Readout
- Sep 24VKTXStock Offering
- Sep 24LLYAcquisition ($3.25B)
- Sep 24BDMDBDMD — Stock Offering (424B5)
- Sep 24BKHABlack M&A / Acquisition
- Sep 2026~LITSLITS Earnings Report
- Sep 25HMDCFAcquisition — GlaxoSmithKline
- Sep 25GSKAcquisition ($750M)
- Sep 25IVAIVA Earnings Report
- Sep 25LEGNData Readout - Carvykti
- Sep 25CLDWWCalidi Corporate Update
- Sep 25INBPINC Reports Financial Results
- Sep 2026~AZNCFZibotentan/Dapagliflozin Phase 2 Est. Readout
- Sep 26CADLConference — Aglatimagene Besadenovec
Week 4Sep 28 - Oct 4(50 catalysts)
Past
Regulatory Decision - daraxonrasib
daraxonrasibPhase 3
NSCLC (Non-small Cell Lung Cancer)
Sep 30AI-detected
✓PositiveSource- Sep 2026~OCGNOCU410ST Phase 3 Est. Readout
- Sep 28BNTCBNTC Earnings Report
- Sep 28ADXNADXN Earnings Report
- Sep 2026~PBMPBM Earnings Report
- Sep 28AZTRAZTR — Stock Offering (424B5)
- Sep 2026~INCYINCB099280 Phase 2 Est. Readout
- Sep 28KODKSI-101 Phase 3 Est. Readout
- Sep 28CSTLData Readout - TissueCypher® Barrett's Esophagus Test
- Sep 2026~MLTXSonelokimab Phase 3 Est. Readout
- Sep 2026~SHPHSHPH Earnings Report
- Sep 29NVOData Readout - Ozempic
- Sep 29LIMNLiminatus Corporate Update
- Sep 29LXEOAcquisition
- Sep 2026~NAIINAII Earnings Report
- Sep 2026~SNYAmlitelimab Phase 2 Est. Readout
- Sep 29BYSIBYSI — Stock Offering (424B5)
- Sep 2026~NBPNBP Earnings Report
- Sep 2026~HLUYYLu AG13909 Phase 2 Est. Readout
- Sep 2026~RHHBYCrizotinib Phase 3 Est. Readout
- Sep 2026~CGTXgolexanolone Phase 2 Est. Readout
- Sep 2026~HNSA.STGNT0003 Phase 2 Est. Readout
- Sep 2026~AMGNPegaspargase Phase 3 Est. Readout
- Sep 2026~RYTMSetmelanotide Phase 3 Est. Readout
- Sep 2026~NVSIptacopan (LNP023) Phase 2 Est. Readout
- Sep 30VNRXTrial Start - DETECSEPS
- Sep 2026~AZNCFRosuvastatin Phase 2 Est. Readout
- Sep 30CALCCALC — Stock Offering (424B5)
- Sep 30AZNAcquisition ($2B)
- Sep 30IVVDPhase 3 — VYD2311
- Sep 2026~RPTXRP-3500 Phase 2 Est. Readout
- Sep 30TLSAPhase 2 — intranasal foralumab
- Sep 2026~BEIGFOxaliplatin Phase 3 Est. Readout
- Sep 2026~MRTXAdagrasib oral dose of 400 mg twice daily tablets Phase 2 Est. Readout
- Sep 2026~HGZDYIBI112 Phase 3 Est. Readout
- Sep 2026~DSKYFIfinatamab deruxtecan Phase 2 Est. Readout
- Sep 30SYREData Readout
- Sep 2026~TPTXOral repotrectinib (TPX-0005) Phase 2 Est. Readout
- Sep 2026~HNPHYTopotecan Phase 3 Est. Readout
- Sep 30ZEALData Readout - petrelintide
- Sep 2026~AZNCFDurvalumab Phase 3 Est. Readout
- Sep 30CRBPPhase 1 — CRB-913
- Sep 2026~QUREAMT-162 Phase 2 Est. Readout
- Sep 2026~DSKYFDato-DXd Phase 3 Est. Readout
- Sep 2026~RZLTRZLT Earnings Report
- Sep 2026~PTNPTN Earnings Report
- Sep 2026~CLGNCLGN Earnings Report
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About PDUFA Dates in September 2026
This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for September 2026. 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.