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PDUFA Dates June 2027: 5 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 →

5 FDA decisions (PDUFA target action dates) fall in June 2027: 2 with a confirmed day. Next: UGN-103 (URGN) on Jun 14. Each row shows the drug, company, indication, status and how firm the date is.

FDA decisions in June 2027
DateCompanyDrugIndicationEventStatusDateTrack
~JuneOCULAxpaxliwet age-related macular degeneration (wet AMD)PDUFAPendingAI-detected · source
Jun 14URGNUGN-103recurrent low-grade intermediate-risk non–muscle invasive bladder cancerPDUFAPendingConfirmed · source
Jun 15MRKsac-TMTEndometrial cancer in adult patients previously treated with platinum-containing chemotherapy and a PD-1/PD-L1 inhibitorPDUFAPendingConfirmed · source
~JuneJHPCYSumecigrel CapsuleantiplateletPDUFAPendingAI-detected · source
~JuneQUREifezuntirgene inilparvovecHuntington's diseasePDUFAPendingAI-detected · source
156
Total Catalysts
5
PDUFA Dates
148
Trial Results
92
Companies

Week 1May 31 - Jun 6(12 catalysts)

  • Q2 2027~QINCYRuxolitinib Phase 2 Est. Readout (MAGIC V)
  • Q2 2027~QAAPGAPG-115 Phase 2 Est. Readout
  • Q2 2027~QEIKNIMP1734 Phase 2 Est. Readout
  • Q2 2027~QRIGLOlutasidenib Phase 2 Est. Readout
  • Q2 2027~QJHPCYApatinib and Adebrelimab in Combination With chemotherapy Phase 2 Est. Readout (ACADEMY)
  • Q2 2027~QINCYRetifanlimab Phase 2 Est. Readout
  • Q2 2027~QAGENBotensilimab Phase 2 Est. Readout (RECTIFY-1)
  • Q2 2027~QNVSPelabresib Phase 3 Est. Readout
  • Q2 2027~QSNYDupilumab Phase 3 Est. Readout
  • Q2 2027~QGSKMomelotinib Phase 2 Est. Readout
  • Q2 2027~QAZNElecoglipron Phase 3 Est. Readout
  • Q2 2027~QCRSPCTX001 Phase 3 Est. Readout

Week 2Jun 7 - Jun 13(11 catalysts)

OCULPDUFA
Jun '27

FDA PDUFA Date Axpaxli

AxpaxliNDA

wet age-related macular degeneration (wet AMD)

Jun 2027~
00%
Source
  • Q2 2027~QHELPCYB003 Phase 3 Est. Readout (EMBRACE)
  • Q2 2027~QESALYLenvatinib Phase 3 Est. Readout
  • Q2 2027~QAZNTozorakimab Phase 2 Est. Readout (Umbriel)
  • Q2 2027~QSNYPCV21 vaccine Phase 3 Est. Readout
  • Q2 2027~QRHHBYFenebrutinib Phase 2 Est. Readout
  • Q2 2027~QTAKVedolizumab Phase 3 Est. Readout
  • Q2 2027~QNVOCagriSema Phase 3 Est. Readout
  • Q2 2027~QVRTXCTX001 Phase 3 Est. Readout
  • Q2 2027~QMRKPembrolizumab Phase 2 Est. Readout
  • Q2 2027~QDSKYFI-DXd Phase 2 Est. Readout

Week 3Jun 14 - Jun 20(69 catalysts)

URGNPDUFA
8mo

FDA PDUFA Date UGN-103

UGN-103Phase 3

recurrent low-grade intermediate-risk non–muscle invasive bladder cancer

Jun 14
00%
Source
UGN-103 FDA decision page →
MRKPDUFA
8mo

FDA PDUFA Date sac-TMT (sacituzumab tirumotecan) (standard)

sac-TMTPhase 3

Endometrial cancer in adult patients previously treated with platinum-containing chemotherapy and a PD-1/PD-L1 inhibitor

Jun 15
00%
SEC
sac-TMT FDA decision page →
  • Q2 2027~QNVOSemaglutide Phase 2 Est. Readout
  • Jun 2027~ZYMEFutibatinib Phase 3 Est. Readout (SAFIR-ABC10)
  • Jun 2027~FDMT4D-710 Phase 2 Est. Readout (CF)
  • Jun 2027~CRVSSoquelitinib Phase 2 Est. Readout (SIERRA1)
  • Jun 2027~MOLN4D-150 IVT (3E10 vg/eye) Phase 3 Est. Readout
  • Jun 2027~KYTXKYV101 Phase 2 Est. Readout (COMPARE)
  • Jun 2027~JHPCYHRS-4642+AG Phase 2 Est. Readout
  • Jun 2027~IPH.PAIPH5201 + durvalumab + standard chemotherapy Phase 2 Est. Readout
  • Jun 2027~GILDSingle dose liposomal Amphotericin and Fluconazole Phase 3 Est. Readout (ACACIA)
  • Jun 2027~SYRESPY001 Phase 2 Est. Readout (SKYLINE-UC)
  • Jun 2027~KPTISelinexor Phase 2 Est. Readout (SENTRY-2)
  • Jun 2027~ORKAORKA-001 Phase 2 Est. Readout (EVERLAST-B)
  • Jun 2027~MANEVDPHL01 QD Phase 3 Est. Readout
  • Jun 2027~AVLNAP01 Phase 2 Est. Readout
  • Jun 2027~SPRYepinephrine Phase 2 Est. Readout
  • Jun 2027~VSTMpanitumumab Phase 2 Est. Readout (TARGET-D 203)
  • Jun 2027~ABBVUpadacitinib Phase 3 Est. Readout
  • Jun 2027~IONSOlezarsen Phase 3 Est. Readout
  • Jun 2027~AKBAPraliciguat Phase 2 Est. Readout
  • Jun 2027~ARWRARO-MAPT-SC Phase 2 Est. Readout
  • Jun 2027~GILDSacituzumab govitecan-hziy (SG) Phase 3 Est. Readout
  • Jun 2027~JHPCYHRS-4642+AG +Adebrelimab Phase 2 Est. Readout
  • Q2 2027~Q4519.TDONQ52 Phase 2 Est. Readout
  • Jun 2027~SNYZ-1018 Phase 2 Est. Readout
  • Jun 2027~HUMAAcellular Tissue Engineered Vessel (ATEV) Phase 3 Est. Readout
  • Jun 2027~INKTagenT-797 Phase 2 Est. Readout
  • Jun 2027~RHHBYMosunetuzumab Phase 2 Est. Readout
  • Jun 2027~JHPCYPyrotinib Phase 3 Est. Readout
  • Jun 2027~JHPCYHRS-4642 Phase 2 Est. Readout
  • Jun 2027~RHHBYIpatasertib Phase 2 Est. Readout
  • Jun 2027~MRKPembrolizumab Phase 2 Est. Readout
  • Jun 2027~ABBVVenetoclax Phase 2 Est. Readout
  • Jun 2027~ALPMYenfortumab vedotin Phase 2 Est. Readout (PlugIN)
  • Jun 2027~BMYKRAS vaccine Phase 2 Est. Readout (DARANIVOVAX)
  • Jun 2027~RVMDRMC-6236 Phase 2 Est. Readout
  • Q2 2027~QMRKTulisokibart Phase 2 Est. Readout
  • Jun 2027~AZNOsimertinib & febuxostat Phase 2 Est. Readout
  • Jun 2027~INBXINBRX-106 Phase 2 Est. Readout
  • Jun 2027~BMYIpilimumab Phase 2 Est. Readout
  • Jun 2027~JAZZCPX-351 Phase 3 Est. Readout
  • Jun 2027~LLYLY4395089 Phase 2 Est. Readout
  • Jun 2027~TNGXTNG462 Phase 2 Est. Readout
  • Jun 2027~SVRAMolgramostim Phase 3 Est. Readout
  • Jun 2027~PFEEnfortumab vedotin Phase 2 Est. Readout
  • Jun 2027~SNDXEntinostat Phase 2 Est. Readout
  • Jun 2027~TXMDVeverimer Phase 3 Est. Readout
  • Jun 2027~BMEAicovamenib Phase 2 Est. Readout
  • Jun 2027~BNTXBNT327 Dose Level 1 (DL1) Phase 2 Est. Readout
  • Jun 2027~GMABVincristine Phase 3 Est. Readout (EPCORE DLBCL-2)
  • Jun 2027~VSTMVS-7375 Phase 2 Est. Readout
  • Jun 2027~BAYRYDarolutamide Phase 2 Est. Readout (PARIS-BIO)
  • Jun 2027~BMYAdministration of BMS-986368 Phase 2 Est. Readout (STIPS)
  • Jun 2027~PHVSDeucrictibant Phase 3 Est. Readout (CREAATE)
  • Jun 2027~RXRXREC-4881 Phase 2 Est. Readout (TUPELO)
  • Jun 2027~ARCTARCT-032 Phase 2 Est. Readout (LunairCF)
  • Jun 2027~IMRXIMM-1-104 Monotherapy (Treatment Group A) Phase 2 Est. Readout
  • Jun 2027~KYMRKT-621 Phase 2 Est. Readout (BROADEN2)
  • Jun 2027~BNTXBNT166a Phase 2 Est. Readout
  • Jun 2027~SKBBYTest product HY0001a for injection Phase 2 Est. Readout
  • Jun 2027~INCYINCMGA00012 Phase 2 Est. Readout
  • Jun 2027~AKBAPraliciguat (Part A) Phase 2 Est. Readout
  • Jun 2027~ARGXEfgartigimod Alfa Phase 2 Est. Readout (PET-AON)
  • Jun 2027~ALKSALKS 2680 Dose 1 Phase 3 Est. Readout
  • Jun 2027~IMMPeftilagimod alfa Phase 3 Est. Readout
  • Q2 2027~QREGNMibavademab Phase 3 Est. Readout
  • Q2 2027~QAZNPlacebo Phase 3 Est. Readout
  • Q2 2027~QTXMDCT3001 Phase 2 Est. Readout

Week 4Jun 21 - Jun 27(10 catalysts)

JHPCYPDUFA
Jun '27

FDA PDUFA Date Sumecigrel Capsule

Sumecigrel CapsuleNDA

antiplatelet

Jun 2027~
00%
Source
  • Q2 2027~QSNYShort-Acting Beta Agonists (SABA) Phase 2 Est. Readout (AIRLYMPUS)
  • Q2 2027~QITCILumateperone high dose Phase 3 Est. Readout
  • Q2 2027~QITCILumateperone low dose Phase 3 Est. Readout
  • Q2 2027~QNVSAlpelisib Phase 2 Est. Readout (EPIK-P3)
  • Q2 2027~QPFEVaccine Candidate #1 Phase 2 Est. Readout
  • Q2 2027~QBPMCAvapritinib Phase 2 Est. Readout
  • Q2 2027~QALM.MCLAD603 Phase 2 Est. Readout
  • Q2 2027~QMRKSuvorexant Phase 3 Est. Readout
  • Q2 2027~QBIIBAPL-3007, pegcetacoplan (APL-2) Phase 2 Est. Readout

Week 5Jun 28 - Jul 4(54 catalysts)

QUREPDUFA
Jun '27

FDA PDUFA Date ifezuntirgene inilparvovec (priority review)

ifezuntirgene inilparvovecNDA

Huntington's disease

Jun 2027~
00%
Source
  • Q2 2027~QIDRS.SWACT-777991 Phase 2 Est. Readout
  • Q2 2027~QSNYIsatuximab Phase 2 Est. Readout
  • Q2 2027~QGSKGSK4524101 Phase 2 Est. Readout
  • Q2 2027~QIMNNIMNN-001 Phase 2 Est. Readout (MRD)
  • Q2 2027~QREGNCemiplimab Phase 2 Est. Readout (MINIMA)
  • Q2 2027~QAZNAZD8421 Phase 2 Est. Readout (CYCAD-1)
  • Q2 2027~QONCTacabrutideg Phase 2 Est. Readout
  • Q2 2027~QRHHBYRanibizumab Phase 3 Est. Readout (HUTONG)
  • Q2 2027~QJHPCYSHR-A1811 Phase 3 Est. Readout
  • Q2 2027~QRHHBYAstegolimab Phase 3 Est. Readout
  • Q2 2027~QIVBXFIBI343 Phase 3 Est. Readout
  • Jun 30LBRXPhase 3 — LB-102
  • Q2 2027~QBMYNivolumab Phase 2 Est. Readout
  • Q2 2027~QSKBBYTagitanlimab Phase 2 Est. Readout
  • Jun 30PHVSPhase 3 — deucrictibant XR
  • Q2 2027~QJHPCYJSKN016 Phase 2 Est. Readout
  • Q2 2027~QAAPGolverembatinib Phase 3 Est. Readout
  • Q2 2027~QRIGLOlutasidenib Phase 2 Est. Readout
  • Q2 2027~QELOXExaluren Phase 2 Est. Readout
  • Q2 2027~QBGNEGemcitabine Hydrochloride Phase 3 Est. Readout
  • Q2 2027~QMIRMBulevirtide and Brelovitug Phase 3 Est. Readout
  • Jun 30TSHAData Readout — REVEAL
  • Jun 30NTLAPhase 3 — lonvo-z
  • Q2 2027~QRHHBYAtezolizumab Phase 3 Est. Readout
  • Q2 2027~QALPMYzolbetuximab Phase 2 Est. Readout
  • Q2 2027~QAZNAcalabrutinib Phase 2 Est. Readout
  • Q2 2027~QAMGNEtelcalcetide Phase 3 Est. Readout
  • Jun 30LNAIPartnership
  • Q2 2027~QJHPCYRamucirumab/Paclitaxel/Docetaxel/Irinotecan Phase 3 Est. Readout
  • Q2 2027~QINDPDecoy20 Phase 2 Est. Readout
  • Q2 2027~QRHHBYRO7247669 Phase 2 Est. Readout
  • Q2 2027~QNVSRapcabtagene autoleucel single agent Phase 2 Est. Readout
  • Q2 2027~QRHHBYPertuzumab Phase 2 Est. Readout
  • Q2 2027~QTEVADeutetrabenazine Phase 3 Est. Readout
  • Q2 2027~QTXMDNVG-2089 Phase 2 Est. Readout
  • Jun 2027~BCAXTrial Start
  • Jun 2027~CLRBPhase 3 Results
  • Q2 2027~QSKBBYSKB571 for injection Phase 2 Est. Readout
  • Q2 2027~QRHHBYVenetoclax Phase 2 Est. Readout
  • Q2 2027~QAZNAZD9793 Intravenous (IV) monotherapy Phase 2 Est. Readout
  • Q2 2027~QRHHBYEntrectinib Phase 2 Est. Readout (STARTRK-NG)
  • Q2 2027~QAMGNSotorasib Phase 3 Est. Readout
  • Q2 2027~QALNYALN-6400 Phase 2 Est. Readout (HMBeacon)
  • Q2 2027~QRHHBYAlectinib Phase 3 Est. Readout (B-FAST)
  • Q2 2027~QAZNFOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan) Phase 2 Est. Readout (CANTOR)
  • Q2 2027~QBLTETinlarebant Phase 3 Est. Readout (PHOENIX)
  • Q2 2027~QNUOXNanO2TM Phase 2 Est. Readout (RESTORE)
  • Q2 2027~QINCYPemigatinib Phase 2 Est. Readout (AcSé PEMI)
  • Q2 2027~QBGNETislelizumab Phase 3 Est. Readout
  • Q2 2027~QAAPGolverembatinib Phase 3 Est. Readout (POLARIS-2)
  • Q2 2027~QMIRMBrelovitug Phase 3 Est. Readout
  • Q2 2027~QADAGADG126 Phase 2 Est. Readout
  • Q2 2027~QBGNEBGB-16673 Phase 2 Est. Readout
May 2027Full CalendarJuly 2027

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PDUFA dates June 2027: questions

How many FDA decisions (PDUFA dates) are in June 2027?
5 PDUFA dates fall in June 2027: 2 with a confirmed day. Updated November 6, 2026.
What is the next FDA decision in June 2027?
UGN-103 from UroGen Pharma Ltd. (URGN), PDUFA target date Jun 14, for recurrent low-grade intermediate-risk non–muscle invasive bladder cancer.
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 June 2027

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