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PDUFA Dates August 2027: 3 FDA Decisions

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 →

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

FDA decisions in August 2027
DateCompanyDrugIndicationEventStatusDateTrack
~AugustJHPCYHS-20093 for Injectionphosphate binderPDUFAPendingEstimated · source
~AugustCADLaglatimagene besadenovecprostate cancerPDUFAPendingAI-detected · source
~AugustUTHRRalinepagPulmonary Arterial HypertensionPDUFAPendingEstimated · source
108
Total Catalysts
3
PDUFA Dates
104
Trial Results
73
Companies

Week 1Jul 26 - Aug 1(4 catalysts)

  • Q3 2027~QTOVXVCN-01 oncolytic adenovirus (zabilugene almadenorepvec) Phase 2 Est. Readout (VIRAGE2)
  • Q3 2027~QSOBI.STEmapalumab Phase 2 Est. Readout
  • Q3 2027~QMRKpembrolizumab Phase 2 Est. Readout
  • Q3 2027~QIVBXFTafolecimab Phase 2 Est. Readout (STAR-SCLC)

Week 2Aug 2 - Aug 8(7 catalysts)

JHPCYPDUFA
Aug '27

FDA PDUFA Date AP301

HS-20093 for InjectionPhase 2

phosphate binder

Aug 2027~
00%
Source
CADLPDUFA
Aug '27

FDA PDUFA Date

aglatimagene besadenovecPhase 3

prostate cancer

Aug 2027~
00%
Source
  • Q3 2027~QAZNOsimertinib Phase 3 Est. Readout (ADAURA2)
  • Q3 2027~QPFEElranatamab Phase 3 Est. Readout
  • Q3 2027~QPFEPF-08653945 Phase 2 Est. Readout (SOLIS-1)
  • Q3 2027~QBIIBTofersen Phase 3 Est. Readout (ATLAS)
  • Q3 2027~QSGIOYS-606001 Phase 2 Est. Readout

Week 3Aug 9 - Aug 15(56 catalysts)

  • Q3 2027~QALNYALN-APP Phase 2 Est. Readout (cAPPricorn-1)
  • Q3 2027~QAZNAcalabrutinib Phase 2 Est. Readout
  • Q3 2027~QREGNALN-PNP Phase 2 Est. Readout
  • Q3 2027~QNVSBION-1301 Phase 3 Est. Readout
  • Q3 2027~QHLUYYLu AG13909 Phase 2 Est. Readout (BalanCeD)
  • Q3 2027~QMRKISL Phase 2 Est. Readout
  • Q3 2027~QACRVACR-2316 Phase 2 Est. Readout
  • Q3 2027~QBNTXDB-1305/BNT325 Phase 2 Est. Readout
  • Aug 2027~GILDGS-3242 Phase 2 Est. Readout
  • Aug 2027~ABBVRisankizumab Phase 3 Est. Readout (REVAMP)
  • Aug 2027~INCYItacitinib Phase 2 Est. Readout (ABNL-MARRO)
  • Aug 2027~IONSION582 Phase 3 Est. Readout
  • Aug 2027~GILDGS-3242 Tablet Phase 2 Est. Readout
  • Aug 2027~GSKNiraparib Phase 2 Est. Readout
  • Aug 2027~PVLAPTX-022 Phase 2 Est. Readout (LOTU)
  • Aug 2027~KRROKRRO-121 Phase 2 Est. Readout (ANCHOR)
  • Aug 2027~GTHXTrilaciclib Phase 2 Est. Readout (ToPCourT)
  • Aug 2027~REGNCemiplimab Phase 2 Est. Readout (TRIPL)
  • Aug 2027~BIIBPegcetacoplan Phase 3 Est. Readout
  • Aug 2027~COAGHMB-001 Phase 2 Est. Readout
  • Aug 2027~ABBVVenetoclax Phase 3 Est. Readout
  • Aug 2027~ABBVRisankizumab Phase 3 Est. Readout
  • Aug 2027~SUPNSPN-817 Phase 2 Est. Readout
  • Aug 2027~ABBVTelisotuzumab Adizutecan Phase 3 Est. Readout
  • Aug 2027~IMCRTebentafusp-Tebn Phase 2 Est. Readout
  • Aug 2027~ESALYLenvatinib + Letrozole Phase 2 Est. Readout
  • Aug 2027~LNTHLNTH2403 Phase 1 dose Phase 2 Est. Readout
  • Aug 2027~DCPHInlexisertib Phase 2 Est. Readout
  • Aug 2027~REGNFianlimab Phase 2 Est. Readout
  • Aug 2027~SGMTDenifanstat Phase 3 Est. Readout
  • Aug 2027~AAPGLisaftoclax (APG-2575) Phase 3 Est. Readout
  • Aug 2027~BHVNBHV-8000 Phase 3 Est. Readout
  • Aug 2027~ZLABZL-1310 Phase 2 Est. Readout
  • Aug 2027~RARETriheptanoin Phase 3 Est. Readout
  • Aug 2027~OTSKFEB-1020 (Centanafadine) low dose Phase 3 Est. Readout
  • Aug 2027~VRTXCRN09682 Phase 2 Est. Readout
  • Aug 2027~VRTXPaltusotine Phase 3 Est. Readout
  • Aug 2027~NBIXNBI-1117570 Phase 2 Est. Readout
  • Aug 2027~PRLDPRT3789 Phase 2 Est. Readout
  • Aug 2027~DFTXMM402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA)) Phase 2 Est. Readout
  • Aug 2027~IPN.PANanoliposomal irinotecan Phase 2 Est. Readout
  • Aug 2027~BNTXDB-1303/BNT323 Phase 2 Est. Readout
  • Aug 2027~OCUPPhentolamine Ophthalmic Phase 3 Est. Readout (LYNX-3)
  • Aug 2027~TVTXPegtibatinase Phase 3 Est. Readout (HARMONY)
  • Aug 2027~JNJTeclistamab Phase 2 Est. Readout
  • Aug 2027~CLYMBudoprutug Phase 2 Est. Readout
  • Aug 2027~ASNDTransCon IL-2 β/γ Phase 2 Est. Readout (IL Believe)
  • Aug 2027~DFTXDT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA)) Phase 2 Est. Readout
  • Aug 2027~KPRXKIO-301 Phase 2 Est. Readout (ABACUS-2)
  • Aug 2027~IONSobudanersen Phase 3 Est. Readout
  • Aug 2027~CLLSUCART20x22 Phase 2 Est. Readout (NatHaLi-01)
  • Aug 2027~LPCNLPCN 1154A Phase 3 Est. Readout (BLOOM)
  • Aug 2027~AVEOFiclatuzumab Phase 3 Est. Readout (FIERCE-HN)
  • Aug 2027~ACADACP-211 Phase 2 Est. Readout (NORLIGHT)
  • Aug 2027~TRVINAL ER Phase 3 Est. Readout (OCEAN-2)
  • Aug 2027~LLYOrforglipron Phase 3 Est. Readout

Week 4Aug 16 - Aug 22(12 catalysts)

UTHRPDUFA
Aug '27

FDA PDUFA Date Ralinepag

RalinepagPhase 3

Pulmonary Arterial Hypertension

Aug 2027~
00%
Source
  • Q3 2027~QVSTMAvutometinib Phase 2 Est. Readout
  • Q3 2027~QREGNALN-CIDEB Phase 2 Est. Readout
  • Q3 2027~QJNJAmivantamab Phase 2 Est. Readout (PALOMA-2)
  • Q3 2027~QBMYBMS-986489 (BMS-986012+Nivolumab) Phase 3 Est. Readout
  • Q3 2027~QIPN.PACorabotase Phase 2 Est. Readout (LANTIC)
  • Q3 2027~QIPN.PACorabotase Phase 2 Est. Readout
  • Q3 2027~QIPSEYDysport Phase 2 Est. Readout (LANTIC)
  • Q3 2027~QTXMDEtavopivat Phase 2 Est. Readout
  • Q3 2027~QAMGNMaridebart cafraglutide Phase 3 Est. Readout (MARITIME-OSA-1)
  • Q3 2027~QARWRzodasiran Injection Phase 3 Est. Readout
  • Q3 2027~QMRKCetuximab/avelumab Phase 2 Est. Readout (AVEC-119)

Week 5Aug 23 - Aug 29(7 catalysts)

  • Q3 2027~QAZNRavulizumab Phase 3 Est. Readout
  • Q3 2027~QSNYVaxneuvance vaccine Phase 3 Est. Readout
  • Q3 2027~QAMGNMaridebart cafraglutide Phase 2 Est. Readout
  • Q3 2027~QGSKBLU-5937 Phase 3 Est. Readout (CALM-2)
  • Q3 2027~QNVOEtavopivat Phase 3 Est. Readout (Hibiscus 2)
  • Aug 27TEVArasagiline mesylate Patent Expiration
  • Q3 2027~QINCYTafasitamab Phase 2 Est. Readout

Week 6Aug 30 - Sep 5(22 catalysts)

  • Q3 2027~QSKBBYEnvafolimab Phase 2 Est. Readout
  • Q3 2027~QONCYPelareorep Phase 2 Est. Readout
  • Q3 2027~QAMGNMaridebart cafraglutide Phase 3 Est. Readout (MARITIME-OSA-2)
  • Q3 2027~QMRNAmRNA-3927 Phase 2 Est. Readout
  • Q3 2027~QCMPSCTX-009 Phase 3 Est. Readout
  • Q3 2027~QALNYALN-4324 Phase 2 Est. Readout
  • Q3 2027~QRIGLOlutasidenib Phase 2 Est. Readout
  • Q3 2027~QRHHBYObinutuzumab Phase 3 Est. Readout (GLOBRYTE)
  • Q3 2027~QGMABEpcoritamab Phase 2 Est. Readout
  • Q3 2027~QREGNLinvoseltamab Phase 2 Est. Readout (IMMUNOPLANT)
  • Q3 2027~QSNYBelumosudil mesylate Phase 2 Est. Readout
  • Q3 2027~QRHHBYZN-A-1041 Phase 2 Est. Readout
  • Q3 2027~QABBVIbrutinib Phase 2 Est. Readout
  • Q3 2027~QAZNAZD6793 Phase 2 Est. Readout (PRESTO)
  • Q3 2027~QBNTXGotistobart Phase 3 Est. Readout (PRESERVE-003)
  • Q3 2027~QCRDFOnvansertib Phase 2 Est. Readout
  • Q3 2027~QAMGNTarlatamab Phase 2 Est. Readout
  • Q3 2027~QSKBBYSKB571 for injection Phase 2 Est. Readout
  • Q3 2027~QJHPCYHS-10365 capsules Phase 2 Est. Readout
  • Q3 2027~QIARTBioDFence G3 Placental Tissue Membrane Phase 2 Est. Readout (HAMMER)
  • Q3 2027~QMRKRecombinant Vesicular Stomatitis Vaccine for Ebola (rVSV∆G-ZEBOV-GP) Phase 2 Est. Readout
  • Q3 2027~QMIRMBrelovitug (BJT-778) Phase 3 Est. Readout
July 2027Full CalendarSeptember 2027

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PDUFA dates August 2027: questions

How many FDA decisions (PDUFA dates) are in August 2027?
3 PDUFA dates fall in August 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 August 2027

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