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12 FDA decisions (PDUFA target action dates) fall in May 2027: 8 with a confirmed day, 1 already decided. Next: AMT-191 (QURE) on May 1. Each row shows the drug, company, indication, status and how firm the date is.
| Date | Company | Drug | Indication | Event | Status | Date | Track |
|---|---|---|---|---|---|---|---|
| May 1 | QURE | AMT-191 | Fabry Disease | PDUFA | Pending | Confirmed · source | |
| May 1 | AXSM | AXS-12 (reboxetine) | Narcolepsy | PDUFA | Pending | Confirmed · source | |
| May 8 | BBIO | Encaleret | autosomal dominant hypocalcemia type 1 (ADH1) | PDUFA | Pending | Confirmed · source | |
| ~May | RGNX | Regenxbio gene therapy (unnamed) | Duchenne muscular dystrophy | PDUFA | Pending | AI-detected · source | |
| May 13 | BMY | mezigdomide | relapsed or refractory multiple myeloma (RRMM), in combination with carfilzomib and dexamethasone (MeziKd) | PDUFA | Pending | Confirmed · source | |
| ~May | REPL | RP1 | advanced melanoma | PDUFA | Pending | AI-detected · source | |
| May 27 | ZBIO | Obexelimab | IgG4-RD accepted by FDA; PDUFA target action date of May 27 | PDUFA | Pending | Confirmed · source | |
| May 27 | RPRX | tislelizumab | pediatric Tourette syndrome and granted the application Priority Review with a PDUFA date late in the first quarter of 2027 | PDUFA | Pending | Confirmed · source | |
| ~May | RHHBY | Fenebrutinib | relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) | PDUFA | Pending | Estimated · source | |
| May 28 | ETON | — | — | PDUFA | Pending | AI-detected · source | |
| ~May | BMY | Camzyos | symptomatic oHCM in adolescents aged 12 to under 18 years | PDUFA | Approved | AI-detected · source | |
| May 30 | BMRN | — | — | PDUFA | Pending | AI-detected · source |
106
Total Catalysts
12
PDUFA Dates
90
Trial Results
61
Companies
Week 1Apr 26 - May 2(13 catalysts)
- Q2 2027~QNVSAsciminib Phase 2 Est. Readout
- May 2027~DSKYFQuizartinib Phase 2 Est. Readout
- May 2027~CMPSCTX-009 Phase 2 Est. Readout
- May 2027~BAYRYRegorafenib (CT) Phase 2 Est. Readout
- May 2027~GILDSacituzumab Govitecan Phase 2 Est. Readout
- May 2027~DSKYF89Zr-Patritumab deruxtecan Phase 2 Est. Readout
- Q2 2027~QTXMDALT-100 mAb Phase 2 Est. Readout
- Q2 2027~QPFE15-valent pneumococcal conjugate vaccine (PCV15) Phase 2 Est. Readout
- Q2 2027~QPFEAbrocitinib Phase 3 Est. Readout
Week 2May 3 - May 9(14 catalysts)
- May 2027~DSKYFTrastuzumab deruxtecan Phase 3 Est. Readout
- Q2 2027~QAZNPertuzumab Phase 3 Est. Readout
- Q2 2027~QAZNFluorouracil (5-FU) Phase 2 Est. Readout
- Q2 2027~QAMGNBisphosphonate Phase 3 Est. Readout
- Q2 2027~QDSKYFTrastuzumab deruxtecan Phase 2 Est. Readout (DG-03)
- May 2027~AMGNRomosozumab Phase 3 Est. Readout
- May 5VCREOther - buloxibutid
- Q2 2027~QUCBJYRozanolixizumab Phase 3 Est. Readout (cosMOG)
- Q2 2027~QSNYFrexalimab Phase 3 Est. Readout (FREXALT)
- Q2 2027~QIVBXFIBI362 Phase 3 Est. Readout
- Q2 2027~QRYTMRM-718 Phase 2 Est. Readout
Week 3May 10 - May 16(39 catalysts)
- Q2 2027~QNVSInclisiran Sodium Phase 3 Est. Readout (VICTORION-2P)
- Q2 2027~QREGNUbamatamab Phase 2 Est. Readout
- Q2 2027~QRHHBYBaloxavir Marboxil Phase 3 Est. Readout (Pebblestone)
- Q2 2027~QUCBJYZilucoplan Phase 3 Est. Readout (ziMyG)
- Q2 2027~QNVOCagrilintide Phase 3 Est. Readout (RENEW 2)
- May 2027~LLYLY4005130 Phase 2 Est. Readout
- May 2027~ABBVLutikizumab Phase 2 Est. Readout (EMBARK)
- May 2027~BNTXPM8002 Phase 2 Est. Readout
- May 2027~IBRXN-803 Phase 2 Est. Readout
- May 2027~IRONDISC-0974 Phase 2 Est. Readout
- May 2027~LLYMirikizumab Phase 2 Est. Readout (TOPAZ-UC)
- May 2027~BOLTBDC-4182 Phase 2 Est. Readout
- May 2027~KLRARibupatide Phase 2 Est. Readout
- May 2027~ZURATibulizumab Phase 2 Est. Readout
- May 2027~ALKSALKS 2680 Dose 3 Phase 3 Est. Readout
- May 2027~JHPCYPaclitaxel Injection Phase 3 Est. Readout
- May 2027~VXRTVXA-CoV2-3.1 Phase 2 Est. Readout
- May 2027~VTRSTransdermal system containing progestin Phase 3 Est. Readout
- May 2027~TXMDLeriglitazone Phase 3 Est. Readout
- May 2027~ALPMYEnzalutamide Phase 2 Est. Readout
- May 2027~AMGNCarfilzomib Phase 2 Est. Readout
- May 2027~GILDSacituzumab Govitecan-hziy Phase 2 Est. Readout (ASCENT-J02)
- May 2027~OTSKFIRL757 Phase 2 Est. Readout (LIFT-PD)
- May 2027~OTSKFDelamanid Phase 2 Est. Readout (DRAMATIC)
- May 2027~ABBVUpadacitinib Oral Product Phase 3 Est. Readout (RESCUE UC)
- Q2 2027~QREGNCemiplimab Phase 2 Est. Readout
- May 2027~SKBBYSKB264 Phase 3 Est. Readout
- May 2027~EXELCabozantinib Phase 2 Est. Readout (Cyto-KIK)
- May 2027~JHPCYSHR-A1811 Phase 3 Est. Readout
- May 2027~ADPTVenetoclax with anti CD20 monoclonal antibody Phase 2 Est. Readout
- May 2027~VCREBuloxibutid Phase 2 Est. Readout (ASPIRE)
- May 2027~ABBVUbrogepant Phase 3 Est. Readout (Ubro Peds)
- May 2027~OTSKFDelamanid Phase 2 Est. Readout
- May 2027~LLYLY3650150 Phase 3 Est. Readout
- May 2027~IMVTIMVT-1402 Phase 2 Est. Readout
- May 2027~XENEAzetukalner Phase 3 Est. Readout (X-NOVA3)
- May 2027~ALKSALKS 2680 Dose 1 Phase 3 Est. Readout (Brilliance NT1)
- Q2 2027~QNVOCDR132L Phase 2 Est. Readout (8282-Reduced)
Week 4May 17 - May 23(11 catalysts)
- Q2 2027~QNVSGIA632 Phase 2 Est. Readout
- Q2 2027~QUCBJYGalvokimig Phase 2 Est. Readout
- Q2 2027~QSNYPCV21 vaccine Phase 3 Est. Readout
- Q2 2027~QSNYPentavalent Meningococcal ABCYW vaccine Phase 2 Est. Readout
- Q2 2027~QREGNREGN7508 Phase 3 Est. Readout (ROXI-ASPEN)
- Q2 2027~QAMGNTarlatamab Phase 2 Est. Readout
- Q2 2027~QNVOCagrilintide Phase 3 Est. Readout (RENEW 4)
- Q2 2027~QSNYSAR402663 Phase 2 Est. Readout
- Q2 2027~QTAKZasocitinib Phase 3 Est. Readout
- Q2 2027~QMRKNemtabrutinib Phase 3 Est. Readout
- Q2 2027~QBIIBBIIB017 (peginterferon beta-1a) Phase 3 Est. Readout
Week 5May 24 - May 30(21 catalysts)
- Q2 2027~QALM.MCLAD191 Phase 2 Est. Readout
- Q2 2027~QTVRDTTI-101 Phase 2 Est. Readout
- Q2 2027~QNVSARV-766 Part A&B Phase 2 Est. Readout
- Q2 2027~QIBRXCD19 t-haNK- IV Administration Phase 2 Est. Readout
- Q2 2027~QOTSKFCentanafadine XR Phase 3 Est. Readout
- Q2 2027~QMRKpembrolizumab Phase 3 Est. Readout
- Q2 2027~QAZNDanicopan Phase 3 Est. Readout
- Q2 2027~QAZNAZD5305 Phase 2 Est. Readout
- Q2 2027~QALNYALN-4324 Phase 2 Est. Readout
- Q2 2027~QSWTXNirogacestat oral tablet Phase 2 Est. Readout
- Q2 2027~QJHPCYKN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection) Phase 2 Est. Readout
- Q2 2027~QHNPHYHS-10542 Phase 2 Est. Readout
- Q2 2027~QWXINWRD08 administered by electroporation Phase 2 Est. Readout
- Q2 2027~QACRVACR-368 Phase 2 Est. Readout
Week 6May 31 - Jun 6(8 catalysts)
- Q2 2027~QVRTXSuzetrigine Phase 3 Est. Readout
- Q2 2027~QANNXTanruprubart Phase 3 Est. Readout
- Q2 2027~QCGTXCT1812 Phase 2 Est. Readout
- Q2 2027~QRHHBYCalciumfolinat Phase 2 Est. Readout
- Q2 2027~QLLYAbemaciclib Phase 2 Est. Readout (UPLIFT)
- Q2 2027~QPFEBinimetinib Phase 2 Est. Readout
- Q2 2027~QRVMDRMC-6236 Phase 2 Est. Readout
- Q2 2027~QBIIBFelzartamab Phase 3 Est. Readout (PREVAIL)
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PDUFA dates May 2027: questions
- How many FDA decisions (PDUFA dates) are in May 2027?
- 12 PDUFA dates fall in May 2027: 8 with a confirmed day, 1 already decided. Updated November 6, 2026.
- What is the next FDA decision in May 2027?
- AMT-191 from uniQure N.V. (QURE), PDUFA target date May 1, for Fabry Disease.
- 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 May 2027
This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for May 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.