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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
Cingulate Inc. stock logo
CING
Cingulate
$4.39
-10.8%
May 31, 2026 CTx-1301 Attention Deficit/Hyperactivity Disorder (ADHD)
NDA
10/14/2025 - PDUFA Date Cingulate Inc. announced that The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target …
Full Summary
Arvinas, Inc. stock logo
ARVN
Arvinas
$9.42
-4.6%
June 5, 2026 Vepdegestrant For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
NDA
8/8/2025 - PDUFA Date Arvinas, Inc. announced that The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action d…
Full Summary
Allogene Therapeutics, Inc. stock logo
ALLO
Allogene Therapeutics
$2.14
-8.2%
H1 2026 Cemacabtagene Ansegedleucel For Patients with Large B-Cell Lymphoma (LBCL) Likely to Relapse 6/20/2024 - Enrollment Update Allogene Therapeutics Inc announced that ALPHA3 Expected to Complete Enrollment in 1H 2026
Full Summary
Akero Therapeutics, Inc. stock logo
AKRO
Akero Therapeutics
$54.65
+0.2%
H1 2026 Efruxifermin Non-alcoholic steatohepatitis (NASH) 1/13/2025 - Data Akero Therapeutics, Inc announced that Data from SYNCHRONY Real-World study anticipated in the first…
Full Summary
Kymera Therapeutics, Inc. stock logo
KYMR
Kymera Therapeutics
$84.50
-1.3%
H1 2026 KT-474 Hidradenitis Suppurativa or Atopic Dermatitis (AD)
Phase 2b
1/14/2025 - Provided Update Kymera Therapeutics announced that KT-474/SAR444656 (IRAK4) Phase 2b dose-ranging studies in hidrade…
Full Summary
X4 Pharmaceuticals, Inc. stock logo
XFOR
X4 Pharmaceuticals
$4.00
-5.4%
H1 2026 Mavorixafor In people diagnosed with idiopathic, cyclic, or congenital neutropenia. MAA 1/24/2025 - Provided Update X4 Pharmaceuticals announced that Decision on MAA expected in 1H 2026
Full Summary
MediWound Ltd. stock logo
MDWD
MediWound
$16.80
+3.4%
H1 2026 EscharEx Chronic Wounds 2/12/2025 - Provided Update MediWound Ltd announced that Interim analysis planned after 65% of patients complete treatment, expe…
Full Summary
Q32 Bio Inc. stock logo
QTTB
Q32 Bio
$6.25
+5.2%
H1 2026 Bempikibart For Severe Alopecia Areata 4/16/2025 - Data readout Q32 Bio Inc. announced that SIGNAL-AA Part B topline data readout on-track for 1H'26 --
Full Summary
Briacell Therap stock logo
BCTX
Briacell Therap
$4.05
-3.1%
H1 2026 Bria-IMT Metastatic breast cancer (breast cancer that has spread beyond the breast)
Phase 3
4/22/2025 - Top-line data BriaCell anticipates top line data as early as H1-2026.
Full Summary
Zymeworks Inc. stock logo
ZYME
Zymeworks
$23.96
-2.5%
H1 2026 ZW209 For small cell lung cancer
IND
4/25/2025 - IND Filing Zymeworks announced that Novel T cell engager ZW209 demonstrates durable activity in small cell lung…
Full Summary
Connect Biopharma Holdings Limited Sponsored ADR stock logo
CNTB
Connect Biopharma
$2.48
+1.2%
H1 2026 Rademikibart For Moderate-To-Severe Atopic Dermatitis 5/14/2025 - Top-line data Connect Biopharma Holdings Limited Expect to report topline data from the Seabreeze STAT COPD study …
Full Summary
Monte Rosa Therapeutics, Inc. stock logo
GLUE
Monte Rosa Therapeutics
$18.68
-1.5%
H1 2026 MRT-8102 For the treatment of inflammatory diseases
Phase 1
6/10/2025 - Results Monte Rosa Therapeutics, Inc. announced that MRT-8102 Phase 1 clinical results, including data on s…
Full Summary
Lipocine Inc. stock logo
LPCN
Lipocine
$2.33
+0.4%
Q2 2026 LPCN 1154 Postpartum depression (PPD)
Phase 3
6/26/2025 - Top-line results Lipocine Inc announced that Phase 3 Top Line Results Expected Q2 2026
Full Summary
Cassava Sciences, Inc. stock logo
FLNA
Cassava Sciences
$1.24
+0.8%
H1 2026 Simufilam Alzheimer's Disease 8/4/2025 - Clinical Study Cassava Sciences, Inc. announced that First clinical study for simufilam in TSC-related epilepsy ex…
Full Summary
Intellia Therapeutics, Inc. stock logo
NTLA
Intellia Therapeutics
$13.09
-8.3%
H1 2026 onvo-z hereditary angioedema 9/18/2025 - Top-line data Intellia Therapeutics, announced that Topline data are expected in the first half of 2026.
Full Summary
CorMedix Inc stock logo
CRMD
CorMedix
$7.93
+5.7%
Q2 2026 REZZAYO in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT). 9/29/2025 - Top-line results CorMedix Inc. announced that Topline Results from ReSPECT Study Expected in 2Q 2026
Full Summary
Lipocine Inc. stock logo
LPCN
Lipocine
$2.33
+0.4%
Q2 2026 LPCN 1154 Postpartum depression (PPD) 9/30/2025 - Top-line results Lipocine Inc announced that The study is progressing on track with one-third of planned patients ra…
Full Summary
REGENXBIO Inc. stock logo
RGNX
REGENXBIO
$6.24
-37.8%
Q2 2026 RGX-202 Duchenne Muscular Dystrophy 10/30/2025 - Top-line data REGENXBIO Inc. announced that Topline pivotal data now expected in early Q2 2026
Full Summary
REGENXBIO Inc. stock logo
RGNX
REGENXBIO
$6.24
-37.8%
H1 2026 RGX-202 Duchenne Muscular Dystrophy BLA 10/30/2025 - BLA Filing REGENXBIO Inc. announced that BLA submission in mid-2026
Full Summary
Lipocine Inc. stock logo
LPCN
Lipocine
$2.33
+0.4%
Q2 2026 LPCN 1154 Postpartum depression (PPD) 11/18/2025 - Top-line results Lipocine Inc announced that Topline results are on track for the second quarter of 2026
Full Summary
Rapport Therapeutics, Inc. stock logo
RAPP
Rapport Therapeutics
$37.95
-0.3%
Q2 2026 RAP-219 For CNS Disorders
Phase 3
1/7/2026 - Study Initiation Rapport Therapeutics, Inc announced plans to initiate its Phase 3 program for RAP-219 in FOS in th…
Full Summary
Sarepta Therapeutics, Inc. stock logo
SRPT
Sarepta Therapeutics
$18.68
-0.8%
Q2 2026 SRP-1005-101 Treatment for Huntington's Disease 1/7/2026 - Provided Update Sarepta Therapeutics, Inc announced that Pending approval, Sarepta expects to initiate this first-i…
Full Summary
Scienture Holdings, Inc. stock logo
SCNX
Scienture
$0.41
+0.5%
Q2 2026 Arbli for hypertension 2/3/2026 - Provided Update SCIENTURE HOLDINGS, INC provided a commercial update on ARBLI™ (losartan potassium) oral suspension,…
Full Summary
scPharmaceuticals, Inc. stock logo
SCPH
scPharmaceuticals
$5.67
July 26, 2026 FUROSCIX Decompensated heart failure supplemental New Drug Application (sNDA) 12/1/2025 - PDUFA Date MannKind Corporation The application has been assigned a Prescription Drug User Fee Act (PDUFA) targ…
Full Summary
Lantheus Holdings, Inc. stock logo
LNTH
Lantheus
$96.67
+0.2%
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.
$113.21
-0.2%
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
$5.27
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
$231.05
-0.6%
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
$132.06
-0.7%
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
$104.41
-0.8%
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
$25.80
-2.5%
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
$75.68
-2.5%
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
$24.63
-0.9%
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
$7.13
+2.1%
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
$29.50
+1.0%
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
$10.10
-3.7%
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
$27.75
-4.9%
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
$1.51
-1.9%
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
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$113.21
-0.2%
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
$5.27
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
Cogent Biosciences, Inc. stock logo
COGT
Cogent Biosciences
$34.19
-0.3%
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
$5.37
-1.5%
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
$5.37
-1.5%
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
$58.54
-1.0%
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
REGENXBIO Inc. stock logo
RGNX
REGENXBIO
$6.24
-37.8%
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
$8.41
+4.2%
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
$6.95
-5.7%
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
$111.39
+2.0%
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
$4.80
-5.7%
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
$13.81
-1.6%
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
$69.66
+1.5%
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
Nuvation Bio Inc. stock logo
NUVB
Nuvation Bio
$4.71
-1.6%
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
$16.15
-1.1%
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
PMV Pharmaceuticals, Inc. stock logo
PMVP
PMV Pharmaceuticals
$1.33
+3.1%
Q1 2027 rezatapopt in patients with advanced solid tumors
NDA
10/24/2025 - NDA Filing PMV Pharmaceuticals, announced that
Full Summary
Nanobiotix S.A. - Sponsored ADR stock logo
NBTX
Nanobiotix
$55.07
+5.8%
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
$31.41
-2.8%
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

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