How many FDA decisions (PDUFA dates) are in September 2027?

2 PDUFA dates fall in September 2027: 0 with a confirmed day. Updated 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.

August 2027

PDUFA Dates September 2027: 2 FDA Decisions

Updated November 6, 2026

October 2027

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 →

2 FDA decisions (PDUFA target action dates) fall in September 2027: 0 with a confirmed day. Each row shows the drug, company, indication, status and how firm the date is.

FDA decisions in September 2027
Date	Company	Drug	Indication	Event	Status	Date	Track
~September	HCM	ORPATHYS plus TAGRISSO	MET-driven EGFR-mutated lung cancer	PDUFA	Pending	AI-detected · source
~September	ATRA	Ebvallo	posttransplant complication	PDUFA	Pending	AI-detected · source

112

Total Catalysts

PDUFA Dates

110

Trial Results

Companies

Week 1Aug 30 - Sep 5(10 catalysts)

Q3 2027~QIPN.PANALIRIFOX Phase 2 Est. ReadoutPhase 2
Q3 2027~QNVOCagrilintide Phase 3 Est. Readout (REDEFINE 3)Phase 3
Q3 2027~QEXELCabozantinib Phase 2 Est. ReadoutPhase 2
Q3 2027~QBNN.DEINS-GSH Phase 2 Est. Readout (NOSE-PD)Phase 2
Q3 2027~QAZNDato-DXd Phase 3 Est. ReadoutPhase 3
Q3 2027~QDSKYFDato-DXd Phase 3 Est. ReadoutPhase 3
Q3 2027~QAZNFulvestrant injection Phase 2 Est. ReadoutPhase 2
Q3 2027~QDSKYFHER3-DXd Phase 2 Est. ReadoutPhase 2
Q3 2027~QNVSAsciminib Pediatric formulation group Phase 2 Est. ReadoutPhase 2
Q3 2027~QNVONNC0662-0419 Phase 2 Est. ReadoutPhase 2

Week 2Sep 6 - Sep 12(4 catalysts)

Q3 2027~QBIIBBIIB091 Phase 2 Est. ReadoutPhase 2
Q3 2027~QNVSPKN605 Phase 2 Est. ReadoutPhase 2
Q3 2027~QNVSOral dabrafenib and trametinib Phase 2 Est. ReadoutPhase 2
Q3 2027~QSNYPCV21 vaccine Phase 3 Est. ReadoutPhase 3

Week 3Sep 13 - Sep 19(57 catalysts)

Q3 2027~QSNYBelumosudil Phase 2 Est. ReadoutPhase 2
Q3 2027~QTAKVedolizumab IV Phase 3 Est. ReadoutPhase 3
Q3 2027~QSVAInactivated Hepatitis A Vaccine (Human Diploid Cell) Phase 3 Est. ReadoutPhase 3
Sep 2027~MCUJFPyridoxal Phosphate Phase 3 Est. Readout (MEND-PNPO)Phase 3
Sep 2027~ABBVIbrutinib Phase 3 Est. Readout (CLL17)Phase 3
Sep 2027~ALPMYASP3082 Phase 2 Est. Readout (UNLOCK ASP3082)Phase 2
Sep 2027~IONSION775 Phase 2 Est. ReadoutPhase 2
Sep 2027~LLYOrforglipron Phase 3 Est. ReadoutPhase 3
Sep 2027~ABBVIcalcaprant Phase 2 Est. ReadoutPhase 2
Sep 2027~IOVAIOV-4001 Phase 2 Est. ReadoutPhase 2
Sep 2027~LLYRetatrutide Phase 3 Est. ReadoutPhase 3
Sep 2027~IONSION440 Phase 2 Est. ReadoutPhase 2
Sep 2027~ABBVArmour Thyroid Phase 3 Est. ReadoutPhase 3
Sep 2027~ABBVLutikizumab Phase 2 Est. ReadoutPhase 2
Sep 2027~JHPCYHRS-4508 tablet Phase 2 Est. ReadoutPhase 2
Sep 2027~DFTXDT120 Phase 3 Est. ReadoutPhase 3
Sep 2027~CHRSCasdozokitug Phase 2 Est. ReadoutPhase 2
Sep 2027~BTMDIMA402 (Phase Ia) Phase 2 Est. ReadoutPhase 2
Sep 2027~XFORMavorixafor Phase 3 Est. ReadoutPhase 3
Sep 2027~REGNFianlimab Phase 2 Est. ReadoutPhase 2
Sep 2027~ANROALTO-100 Phase 2 Est. ReadoutPhase 2
Sep 2027~ABBVUpadacitinib Phase 3 Est. ReadoutPhase 3
Sep 2027~SKBBYSKB264 Phase 2 Est. ReadoutPhase 2
Sep 2027~AZNDurvalumab Phase 2 Est. ReadoutPhase 2
Sep 2027~AMGNBlinatumomab Phase 3 Est. Readout (Interfant-21)Phase 3
Sep 2027~DSKYFPatritumab deruxtecan Phase 2 Est. Readout (ICARUSBREAST02)Phase 2
Sep 2027~GMABRina-S Phase 3 Est. Readout (RAINFOL-02)Phase 3
Q3 2027~QTEVATEV-56286 Phase 2 Est. Readout (TOPAS-MSA)Phase 2
Sep 2027~KYTXKYV-101 Phase 3 Est. ReadoutPhase 3
Sep 2027~AGENBotensilimab Phase 2 Est. ReadoutPhase 2
Sep 2027~GMABEpcoritamab Phase 2 Est. Readout (EPCORE™ NHL-3)Phase 2
Sep 2027~IMVTIMVT-1402 Phase 2 Est. ReadoutPhase 2
Sep 2027~AZNOlaparib Phase 2 Est. Readout (DRUP)Phase 2
Sep 2027~PSNLAZD2936 Phase 2 Est. Readout (MERIDIAN)Phase 2
Sep 2027~CLYMBudoprutug Phase 2 Est. ReadoutPhase 2
Sep 2027~ASNDNavepegritide Phase 2 Est. Readout (teACH)Phase 2
Sep 2027~BMYIpilimumab Phase 2 Est. ReadoutPhase 2
Sep 2027~WVEWVE-006 Phase 2 Est. ReadoutPhase 2
Sep 2027~ARGXempasiprubart Phase 3 Est. Readout (emvigorate)Phase 3
Sep 2027~ARGXEfgartigimod PH20 SC Phase 3 Est. Readout (ADAPT Jr SC)Phase 3
Sep 2027~LLYEloralintide Phase 2 Est. ReadoutPhase 2
Sep 2027~CLVSTrastuzumab and Pertuzumab (combination treatment) Phase 2 Est. Readout (DRUP)Phase 2
Sep 2027~IMTXIMA402 Phase 2 Est. ReadoutPhase 2
Sep 2027~RHHBYErlotinib Phase 2 Est. Readout (DRUP)Phase 2
Sep 2027~UPBVerekitug Phase 2 Est. ReadoutPhase 2
Sep 2027~IPN.PAPanitumumab Phase 2 Est. Readout (DRUP)Phase 2
Sep 2027~TRVINAL ER Phase 2 Est. Readout (LAKE)Phase 2
Sep 2027~CORTRelacorilant Phase 2 Est. ReadoutPhase 2
Sep 2027~CYTKOmecamtiv Mecarbil (OM) Phase 3 Est. Readout (COMET-HF)Phase 3
Sep 2027~LLYLY3537031 Phase 2 Est. Readout (RENEW-IBS-D)Phase 2
Sep 2027~IVBXFIBI351 combined with cetuximab β Phase 2 Est. ReadoutPhase 2
Sep 2027~CSTLD-Fi Phase 3 Est. ReadoutPhase 3
Sep 2027~ALPMYLeuprorelin Acetate Phase 3 Est. ReadoutPhase 3
Sep 2027~OTSKFOPC-34712FUM/Brexpiprazole fumarate Phase 3 Est. ReadoutPhase 3
Sep 2027~PSNLElacestrant Phase 2 Est. ReadoutPhase 2
Sep 2027~AMGNbemarituzumab, paclitaxel, ramucirumab Phase 2 Est. ReadoutPhase 2
Q3 2027~QMRKNemtabrutinib Phase 2 Est. ReadoutPhase 2

Week 4Sep 20 - Sep 26(12 catalysts)

HCM$2.5BPDUFA

Sep '27

FDA PDUFA Date ORPATHYS plus TAGRISSO (standard review)

ORPATHYS plus TAGRISSONDA

MET-driven EGFR-mutated lung cancer

Sep 2027~AI-detected

00%

Source

ATRA$86MPDUFA

Sep '27

FDA PDUFA Date Ebvallo

EbvalloNDA

posttransplant complication

Sep 2027~AI-detected

00%

Source

Q3 2027~QSKBBYA166 Phase 2 Est. ReadoutPhase 2
Q3 2027~QNVSianalumab s.c. q4w Phase 3 Est. ReadoutPhase 3
Q3 2027~QSNYSAR445399 Phase 2 Est. Readout (CLAROS)Phase 2
Q3 2027~QRHHBYHuman Coagulation Factor VIII Phase 3 Est. Readout (ZEBRHA 1)Phase 3
Q3 2027~QINCYINCA000585 Phase 2 Est. ReadoutPhase 2
Q3 2027~QAMGNTarlatamab Phase 3 Est. Readout (DeLLphi-315)Phase 3
Q3 2027~QMRKGranulocyte Colony-Stimulating Factor (G-CSF) Phase 3 Est. ReadoutPhase 3
Q3 2027~QVRNANebulized Ensifentrine Phase 2 Est. ReadoutPhase 2
Q3 2027~QTAKVedolizumab IV Phase 3 Est. ReadoutPhase 3
Q3 2027~QBIIBNusinersen Phase 3 Est. Readout (ASCEND)Phase 3

Week 5Sep 27 - Oct 3(29 catalysts)

Q3 2027~QINCYINCA034176 Phase 3 Est. Readout (AXemplify-357)Phase 3
Q3 2027~QREGNcemiplimab Phase 3 Est. ReadoutPhase 3
Q3 2027~QPFEibuzatrelvir Phase 3 Est. ReadoutPhase 3
Q3 2027~QMRKBomedemstat Phase 3 Est. ReadoutPhase 3
Q3 2027~QJNJNipocalimab Phase 3 Est. Readout (EPIC)Phase 3
Q3 2027~QAZNAZD8205 Phase 2 Est. ReadoutPhase 2
Q3 2027~QACXPIbezapolstat Phase 2 Est. ReadoutPhase 2
Q3 2027~QAZNEtoposide with Carboplatin or Cisplatin Phase 2 Est. ReadoutPhase 2
Q3 2027~QMRKATG-022 Phase 2 Est. ReadoutPhase 2
Q3 2027~QGMABEpcoritamab Phase 2 Est. Readout (EPCORE™ NHL-2)Phase 2
Q3 2027~QJHPCYTaxane Chemotherapy Phase 2 Est. ReadoutPhase 2
Q3 2027~QLLYcleminorexton Phase 3 Est. ReadoutPhase 3
Q3 2027~QDSKYFValemetostat Phase 2 Est. ReadoutPhase 2
Q3 2027~QALTPemvidutide Phase 2 Est. ReadoutPhase 2
Q3 2027~QAZNNeoantigen DNA vaccine Phase 2 Est. ReadoutPhase 2
Q3 2027~QVRTXELX/TEZ/IVA Phase 3 Est. ReadoutPhase 3
Q3 2027~QAZNOsimertinib Phase 2 Est. ReadoutPhase 2
Q3 2027~QINCYRuxolitinib Phase 2 Est. ReadoutPhase 2
Q3 2027~QMAIA6-Thio-2'-Deoxyguanosine Phase 2 Est. ReadoutPhase 2
Q3 2027~QAZNSaruparib Phase 3 Est. ReadoutPhase 3
Q3 2027~QMRKhMG Phase 3 Est. ReadoutPhase 3
Q3 2027~QMKKGYCetrorelix acetate Phase 3 Est. ReadoutPhase 3
Q3 2027~QGRFSAlpha-1 Phase 3 Est. Readout (SWIFT-SC)Phase 3
Q3 2027~QSNYAmlitelimab Phase 3 Est. Readout (AQUA)Phase 3
Q3 2027~QABBVrituximab, ifosfamide, carboplatin, and etoposide phosphate Phase 2 Est. Readout (EPCORE™ NHL-2)Phase 2
Q3 2027~QBIOI-B.STBI-1206 Phase 2 Est. ReadoutPhase 2
Q3 2027~QVNDATradipitant Phase 3 Est. ReadoutPhase 3
Q3 2027~QRNTXLTI-03 Phase 2 Est. ReadoutPhase 2
Q3 2027~QAZNSaruparib Phase 2 Est. ReadoutPhase 2

August 2027 Full Calendar October 2027

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PDUFA dates September 2027: questions

How many FDA decisions (PDUFA dates) are in September 2027?: 2 PDUFA dates fall in September 2027: 0 with a confirmed day. Updated 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 September 2027

This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for September 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.