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Upcoming FDA Events & PDUFA Dates

MarketBeat's Upcoming FDA Events calendar tracks future PDUFA target dates and scheduled FDA decision deadlines for publicly traded biotech and pharmaceutical companies. Use this calendar to identify potential catalysts before they happen — including upcoming NDA and BLA review deadlines, advisory committee meetings, and expected regulatory milestones.

Each entry includes the target action date and current stock price so you can research potential trades ahead of major FDA decisions.

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Main Company Current Price Target Date Drug Status Event
Replimune Group, Inc. stock logo
REPL
Replimune Group
$11.20
+107.0%
August 2, 2026 RP1 (vusolimogene oderparepvec) In Advanced Melanoma BLA 6/26/2026 - Provided Update Replimune Group, Inc. announced that The FDA considers this a complete, class 1 response with a goa…
Full Summary
Lantheus Holdings, Inc. stock logo
LNTH
Lantheus
$99.64
-1.3%
August 13, 2026 MK-6240 PET Imaging Agent Targeting Tau in Alzheimer's Disease
NDA
10/28/2025 - PDUFA Date Lantheus Holdings, Inc. announced that The FDA has set a Prescription Drug User Fee Act (PDUFA) tar…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$130.49
+0.5%
August 17, 2026 KEYTRUDA QLEX™ Injection for Subcutaneous Use in Adults Across Most Solid Tumor Indications for KEYTRUDA® (pembrolizumab) supplemental New Drug Application (sNDA) Priority Review 4/20/2026 - PDUFA Date Merck announced that The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date o…
Full Summary
Savara Inc. stock logo
SVRA
Savara
$5.46
-1.4%
August 22, 2026 MOLBREEVI Treatment for aPAP. BLA 2/20/2026 - PDUFA Date Savara Inc announced that The FDA granted Priority Review with a PDUFA action date of August 22, 202…
Full Summary
Jazz Pharmaceuticals PLC stock logo
JAZZ
Jazz Pharmaceuticals
$252.86
-2.1%
August 25, 2026 Ziihera For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC) supplemental New Drug Application (sNDA) 4/27/2026 - PDUFA Date Jazz Pharmaceuticals plc announced that The FDA has set a PDUFA target action date of August 25, 20…
Full Summary
Gilead Sciences, Inc. stock logo
GILD
Gilead Sciences
$130.21
-0.8%
August 27, 2026 BIC/LEN treatment of HIV
NDA
4/29/2026 - PDUFA Date Gilead Sciences, Inc announced that The FDA has granted priority review of the application and assi…
Full Summary
Nuvalent, Inc. stock logo
NUVL
Nuvalent
$123.96
September 18, 2026 zidesamtinib ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib
NDA
11/19/2025 - PDUFA Date Nuvalent, Inc. announced that FDA assigns PDUFA target action date of September 18, 2026
Full Summary
Ultragenyx Pharmaceutical Inc. stock logo
RARE
Ultragenyx Pharmaceutical
$24.91
-4.3%
September 19, 2026 UX111 For Sanfilippo syndrome type A (MPS IIIA) BLA 4/2/2026 - PDUFA Date Ultragenyx Pharmaceutical announced that The FDA set a Prescription Drug User Fee Act (PDUFA) action…
Full Summary
Ionis Pharmaceuticals, Inc. stock logo
IONS
Ionis Pharmaceuticals
$51.77
-2.8%
September 22, 2026 Zilganersen for the treatment of children and adults Alexander disease (AxD). NDA Priority Review 3/23/2026 - PDUFA Date Ionis Pharmaceuticals, Inc announced that The FDA has set a Prescription Drug User Fee Act (PDUFA) …
Full Summary
Alumis Inc. stock logo
ALMS
Alumis
$28.25
-2.4%
Q3 2026 ESK-001 In Moderate-to-Severe Plaque Psoriasis 7/24/2025 - Topline Readout Alumis Inc. announced that Topline Readout Expected in Q3 2026
Full Summary
Silence Therapeutics PLC Sponsored ADR stock logo
SLN
Silence Therapeutics
$10.49
-9.7%
Q3 2026 divesiran In patients with polycythemia vera
Phase 2
10/23/2025 - Top-line results Silence Therapeutics plc announced that Initial topline results from the SANRECO Phase 2 study are …
Full Summary
Roivant Sciences Ltd. stock logo
ROIV
Roivant Sciences
$33.91
-1.8%
Q3 2026 Brepocitinib Systemic Lupus Erythematosus
NDA
3/3/2026 - PDUFA Date Priovant Therapeutics announced that The FDA has assigned a Prescription Drug User Fee Act (PDUFA) …
Full Summary
Immix Biopharma, Inc. stock logo
IMMX
Immix Biopharma
$8.32
-2.7%
Q3 2026 NXC-201 NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis. 3/30/2026 - Top-line results Immix Biopharma, Inc. announced that NEXICART-2 enrollment is complete, meeting Company guidance, w…
Full Summary
uniQure N.V. stock logo
QURE
uniQure
$43.63
+3.4%
Q3 2026 AMT-130 Huntington's Disease 4/30/2026 - Provided Update uniQure N.V. announced the Company held a Pre-Submission Meeting with the United Kingdom's (UK) Med…
Full Summary
Allarity Therapeutics, Inc. stock logo
ALLR
Allarity Therapeutics
$1.21
-1.6%
Q3 2026 Stenoparib For ovarian cancer (AOC) 5/5/2026 - Provided Update Allarity Therapeutics, Inc. announced that its active pharmaceutical ingredient (API) manufacturing …
Full Summary
Stoke Therapeutics, Inc. stock logo
STOK
Stoke Therapeutics
$28.86
-3.9%
Q3 2026 zorevunersen For the treatment of Dravet syndrome with a confirmed mutation,
Phase 3
6/30/2026 - Data readout Stoke Therapeutics, Inc announced that Phase 3 data readout is anticipated in the third quarter of …
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$130.49
+0.5%
October 10, 2026 I-DXd In patients with pretreated extensive-stage small cell lung cancer (ES-SCLC). BLA 4/13/2026 - PDUFA Date Daiichi Sankyo and Merck announced that The Prescription Drug User Fee Act (PDUFA) date, the FDA …
Full Summary
Savara Inc. stock logo
SVRA
Savara
$5.46
-1.4%
November 22, 2026 Molgramostim (IMPALA-2) Autoimmune Pulmonary Alveolar Proteinosis (aPAP) 4/15/2026 - PDUFA Date Savara Inc. announced Prescription Drug User Fee Act (PDUFA) Target Action Date Extended by Three Mo…
Full Summary
BridgeBio Pharma, Inc. stock logo
BBIO
BridgeBio Pharma
$80.09
-2.5%
November 27, 2026 BBP-418 Limb Girdle Muscular Dystrophy Type 2i (LGMD2i) 5/27/2026 - PDUFA Date BridgeBio Announces that The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target actio…
Full Summary
Cogent Biosciences, Inc. stock logo
COGT
Cogent Biosciences
$38.93
-5.9%
November 30, 2026 bezuclastinib In patients with non-advanced systemic mastocytosis
NDA
5/28/2026 - PDUFA Date Cogent Biosciences, Inc announced The FDA has granted the application Priority Review and assigned …
Full Summary
Cogent Biosciences, Inc. stock logo
COGT
Cogent Biosciences
$38.93
-5.9%
December 30, 2026 bezuclastinib In patients with non-advanced systemic mastocytosis
NDA
3/16/2026 - PDUFA Date Cogent Biosciences, Inc announced that the Prescription Drug User Fee Act (PDUFA) target action date…
Full Summary
Annexon, Inc. stock logo
ANNX
Annexon
$5.09
-3.4%
H2 2026 ANX007 Geographic Atrophy 9/9/2024 - Data Annexon, Inc. announced that ARCHER II Phase 3 Pivotal Program in GA Underway with Data Expected Se…
Full Summary
Annexon, Inc. stock logo
ANNX
Annexon
$5.09
-3.4%
H2 2026 ANX007 Geographic Atrophy
Phase 3
12/5/2024 - Provided Update Annexon, Inc. Pivotal Phase 3 ARCHER II in GA Actively Enrolling with Data Expected Second Half 2026
Full Summary
Kiniksa Pharmaceuticals International, plc stock logo
KNSA
Kiniksa Pharmaceuticals International
$74.34
-4.9%
H2 2026 KPL-387 In recurrent pericarditis
Phase 2
6/5/2025 - Data Kiniksa Pharmaceuticals International announced that Phase 2 data expected in 2H 2026
Full Summary
Avidity Biosciences, Inc. stock logo
RNA
Avidity Biosciences
$11.35
-1.0%
H2 2026 Delpacibart Braxlosiran In People Living with Facioscapulohumeral Muscular Dystrophy BLA 6/9/2025 - BLA Filing Avidity Biosciences, Inc. announced that Planning accelerated approval BLA submission in H2 2026
Full Summary
REGENXBIO Inc. stock logo
RGNX
REGENXBIO
$9.69
-4.2%
Q4 2026 surabgene lomparvovec for Wet AMD 10/6/2025 - Top-line data REGENXBIO Inc. announced that Topline pivotal data expected in Q4 2026
Full Summary
Adicet Bio, Inc. stock logo
ACET
Adicet Bio
$9.11
+0.6%
H2 2026 ADI-001 B cell non-Hodgkin's lymphoma (NHL)
Phase 1
10/16/2025 - Preclinical Data Adicet Bio, Inc. announced that Preliminary clinical data from the Phase 1 trial expected in 2H/2026
Full Summary
Verrica Pharmaceuticals Inc. stock logo
VRCA
Verrica Pharmaceuticals
$5.22
-0.8%
Q4 2026 YCANTH™ (cantharidin) For molluscum contagiosum, which is primarily a pediatric disease. 10/20/2025 - Provided Update Verrica is initiating activities to support this regulatory submission, which could be filed as earl…
Full Summary
Mirum Pharmaceuticals, Inc. stock logo
MIRM
Mirum Pharmaceuticals
$105.95
-5.9%
Q4 2026 Maralixibat Alagille Syndrome 3/16/2026 - Top-line data Mirum Pharmaceuticals, Inc. announced that the Topline data expected in Q4 2026
Full Summary
Aclaris Therapeutics, Inc. stock logo
ACRS
Aclaris Therapeutics
$5.20
-2.3%
Q4 2026 ATI-045 In Atopic Dermatitis (AD) 3/18/2026 - Top-line results Aclaris Therapeutics, Inc. announced that the Top line results are expected in the fourth quarter o…
Full Summary
Enanta Pharmaceuticals, Inc. stock logo
ENTA
Enanta Pharmaceuticals
$12.60
-3.1%
Q4 2026 EDP-978 Treatment of Urticaria 4/13/2026 - Top-line data Enanta Pharmaceuticals, Inc announced that the Topline Data Expected in Q4 2026
Full Summary
BridgeBio Pharma, Inc. stock logo
BBIO
BridgeBio Pharma
$80.09
-2.5%
H2 2026 BBO-11818 Potent panKRAS Inhibitor 4/20/2026 - Clinical Data BridgeBio Oncology Therapeutics, Inc. announced that the Updated Phase 1 clinical data are expected …
Full Summary
ADC Therapeutics SA stock logo
ADCT
ADC Therapeutics
$1.05
-5.4%
Q4 2026 ZYNLONTA In patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). 6/30/2026 - Data ADC Therapeutics SA announced that the Full data expected in fourth quarter of 2026
Full Summary
Pfizer Inc. stock logo
PFE
Pfizer
$25.10
+0.8%
Q4 2026 TALZENNA Oral inhibitor of poly ADP-ribose polymerase supplemental New Drug Application (sNDA) Priority Review 7/22/2026 - PDUFA Date Pfizer Inc announced that the FDA has set a Prescription Drug User Fee Act (PDUFA) action date in …
Full Summary
NewAmsterdam Pharma Company N.V. stock logo
NAMS
NewAmsterdam Pharma
$27.79
-2.4%
H2 2026 Obicetrapib CETP inhibitor 7/24/2026 - Provided Update NewAmsterdam Pharma Company N.V announced that the European Commission decision expected in 2H26
Full Summary
Nuvation Bio Inc. stock logo
NUVB
Nuvation Bio
$6.33
-5.6%
January 4, 2027 IBTROZI In Advanced ROS1-Positive Non-Small Cell Lung Cancer supplemental New Drug Application (sNDA) 5/6/2026 - PDUFA Date Nuvation Bio Inc announced today that the U.S. Food and Drug Administration (FDA) has accepted a sup…
Full Summary
Cullinan Therapeutics, Inc. stock logo
CGEM
Cullinan Therapeutics
$16.50
-5.8%
February 27, 2027 zipalertinib For patients with heavily pre-treated EGFR ex20ins mutation NSCLC
NDA
4/28/2026 - PDUFA Date Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, announced that The…
Full Summary
BioMarin Pharmaceutical Inc. stock logo
BMRN
BioMarin Pharmaceutical
$60.02
-0.9%
February 28, 2027 vosoritide Children with achondroplasia supplemental New Drug Application (sNDA) 7/13/2026 - PDUFA Date BioMarin Pharmaceutical Inc. announced that The FDA has set a Prescription Drug User Fee Act (PDUFA…
Full Summary
PMV Pharmaceuticals, Inc. stock logo
PMVP
PMV Pharmaceuticals
$1.11
-1.8%
Q1 2027 rezatapopt in patients with advanced solid tumors
NDA
10/24/2025 - NDA Filing PMV Pharmaceuticals, announced that
Full Summary
Stoke Therapeutics, Inc. stock logo
STOK
Stoke Therapeutics
$28.86
-3.9%
Q1 2027 zorevunersen For the treatment of Dravet syndrome with a confirmed mutation, 6/30/2026 - rolling submission Stoke Therapeutics, Inc to initiate a rolling New Drug Application (NDA) submission to the U.S. Food…
Full Summary
Abeona Therapeutics Inc. stock logo
ABEO
Abeona Therapeutics
$6.42
-0.8%
Q1 2027 PMN310 PMN310 is a novel monoclonal antibody 7/28/2026 - Top-line results ProMIS Neurosciences Inc. announced that 12-month topline results expected in Q1 2027
Full Summary
Pharvaris N.V. stock logo
PHVS
Pharvaris
$32.62
-3.7%
April 23, 2027 Deucrictibant For bradykinin-B2-receptor 7/6/2026 - PDUFA Date Pharvaris announced that The FDA has set a Prescription Drug User Fee Act (PDUFA) target action dat…
Full Summary
Organogenesis stock logo
ORGO
Organogenesis
$2.37
-3.3%
April 27, 2027 ReNu for Knee Osteoarthritis 7/6/2026 - PDUFA Date Organogenesis Holdings Inc. announced that the FDA has set a Prescription Drug User Fee Act (PDUFA) …
Full Summary
Axsome Therapeutics, Inc. stock logo
AXSM
Axsome Therapeutics
$217.99
-7.1%
May 1, 2027 AXS-12 Narcolepsy 7/15/2026 - PDUFA Date Axsome Therapeutics, Inc. announced that the FDA sets PDUFA target action date of May 1, 2027
Full Summary
BridgeBio Pharma, Inc. stock logo
BBIO
BridgeBio Pharma
$80.09
-2.5%
May 8, 2027 Encaleret Autosomal Dominant Hypocalcemia Type 1 (ADH1)
NDA
7/22/2026 - PDUFA Date BridgeBio Pharma, Inc. announced that The FDA has assigned a Prescription Drug User Fee Act (PDUFA) …
Full Summary
Bristol Myers Squibb Company stock logo
BMY
Bristol Myers Squibb
$65.44
+0.9%
May 13, 2027 MeziKd Relapsed or Refractory Multiple Myeloma
NDA
7/13/2026 - PDUFA Date Bristol Myers Squibb announced that The U.S. FDA has assigned a target action date of May 13, 2027
Full Summary
Nanobiotix S.A. - Sponsored ADR stock logo
NBTX
Nanobiotix
$38.38
-4.4%
H1 2027 NANORAY-312 head and neck squamous cell cancers. 10/24/2025 - Interim Data Nanobiotix estimates that NANORAY-312 interim data will be analyzed and reported, after both the req…
Full Summary
LB Pharmaceuticals Inc stock logo
LBRX
LB Pharmaceuticals
$40.08
-2.0%
H2 2027 LB-102 In Patients With Bipolar Depression 3/25/2026 - Top-line data LB Pharmaceuticals Inc announced that the Topline data expected in 2H 2027
Full Summary
Aura Biosciences, Inc. stock logo
AURA
Aura Biosciences
$7.01
-1.4%
H2 2027 Belzupacap Sarotalocan (AU-011) Non-Muscle Invasive Bladder Cancer (NMIBC) 6/1/2026 - Top-line data Aura Biosciences Announced that the Topline data for the 15-month primary endpoint are anticipated…
Full Summary
Ionis Pharmaceuticals, Inc. stock logo
IONS
Ionis Pharmaceuticals
$51.77
-2.8%
H2 2027 ION582 Angelman syndrome 7/6/2026 - Top-line data Ionis Pharmaceuticals, Inc announced Topline data from REVEAL anticipated in 2H 2027 -
Full Summary
Eyepoint Pharmaceuticals, Inc. stock logo
EYPT
Eyepoint Pharmaceuticals
$12.25
-4.7%
Q4 2027 DURAVYU In patients with non-proliferative diabetic retinopathy (NPDR). 7/30/2026 - Top-line data EyePoint, Inc. announced that Topline data for both DME trials are anticipated in the fourth quart…
Full Summary

Frequently Asked Questions

The PDUFA date (Prescription Drug User Fee Act) is the FDA’s target deadline to approve or reject a New Drug Application (NDA) or Biologics License Application (BLA). These are major catalysts for biotech stocks, as a decision often triggers significant price movement.

A grant refers to an award of a designation (i.e., RMAT), while a target date usually refers to a PDUFA date (the FDA’s deadline to act on an NDA or BLA).

A submission occurs when a company files an NDA, BLA or supplemental application. If the FDA accepts the application, it enters review and may receive a PDUFA target date. Approval means the FDA has authorized the drug or new indication for marketing. An accepted application or scheduled target date does not guarantee approval.

This calendar includes announced PDUFA target dates, expected FDA decision dates, anticipated NDA and BLA filings, advisory committee meetings, clinical trial data readouts and other scheduled regulatory milestones reported by publicly traded biotechnology and pharmaceutical companies.

No. Some events have exact dates announced by the FDA or the company, while others are company estimates expressed as a month, quarter or half-year. Estimated dates may change as clinical trials, submissions and regulatory reviews progress.

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process