Upcoming FDA Events & PDUFA Dates

Country USA (NYSE & NASDAQ)

• USA (NYSE & NASDAQ)
• USA (All Exchanges)
• Canada
• United Kingdom

Market Cap All MarketCaps

• Mega Cap (More Than $200B)
• Large Cap ($10B-$200B)
• Mid Cap ($2B-$10B)
• Small Cap ($300M-$2B)
• Micro Cap ($50M-$300M)
• Nano Cap (Under $50M)

MarketRank™ evaluates a company based on dividend strength, earnings, valuation, analysts forecasts, and more.
Available with a MarketBeat All Access Subscription

MarketRank™Upgrade to All Access to use the All Ranks Filter

Media sentiment refers to the percentage of positive news stories versus negative news stories a company has received in the past week.
Available with a MarketBeat All Access Subscription

Media SentimentUpgrade to All Access to use the All Sentiments Filter

Analyst consensus is the average investment recommendation among Wall Street research analysts.
Available with a MarketBeat All Access Subscription

Analyst ConsensusUpgrade to All Access to use the All Ratings Filter

Publicly Traded Companies All Companies Include

Export

Main Company	Current Price	Target Date	Drug	Status	Event
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
RARE Ultragenyx Pharmaceutical	$14.40 +0.6%	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
IONS Ionis Pharmaceuticals	$55.65 -0.7%	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
ALMS Alumis	$9.90 +1.0%	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
SLN Silence Therapeutics	$13.31 -1.8%	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
ROIV Roivant Sciences	$40.94 -2.1%	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
IMMX Immix Biopharma	$12.70 +3.2%	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
QURE uniQure	$44.47 -3.3%	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
ALLR Allarity Therapeutics	$1.25 -1.0%	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
STOK Stoke Therapeutics	$29.34 -1.9%	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
MRK Merck & Co., Inc.	$144.68 -1.9%	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
SVRA Savara	$5.32 -1.7%	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
CAPR Capricor Therapeutics	$8.30 -3.9%	November 22, 2026	Deramiocel For the Treatment of Duchenne Muscular Dystrophy	BLA	8/24/2026 - PDUFA Date Capricor Therapeutics announced that the U.S. Food and Drug Administration (FDA) has extended the Pr… Full Summary
BBIO BridgeBio Pharma	$72.50 -4.7%	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
COGT Cogent Biosciences	$34.08 -0.3%	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
COGT Cogent Biosciences	$34.08 -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
ANNX Annexon	$4.14 -5.3%	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
ANNX Annexon	$4.14 -5.3%	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
KNSA Kiniksa Pharmaceuticals International	$76.48 -2.6%	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
RNA Avidity Biosciences	$10.35 -1.5%	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
RGNX REGENXBIO	$8.56 -1.9%	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
ACET Adicet Bio	$9.53 -0.1%	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
VRCA Verrica Pharmaceuticals	$4.95 -2.2%	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
MIRM Mirum Pharmaceuticals	$100.61 +2.3%	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
ACRS Aclaris Therapeutics	$5.51 -0.9%	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
ENTA Enanta Pharmaceuticals	$12.70 -4.1%	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
BBIO BridgeBio Pharma	$72.50 -4.7%	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
ADCT ADC Therapeutics	$1.11 -9.4%	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
PFE Pfizer	$27.63 -0.5%	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
NAMS NewAmsterdam Pharma	$21.86 -4.1%	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
EYPT Eyepoint Pharmaceuticals	$4.25 -2.1%	Q4 2026	DURAVYU In patients with non-proliferative diabetic retinopathy (NPDR).		8/17/2026 - Top-line data EyePoint, Inc. announced that the Topline data from LUCIA, the second pivotal Phase 3 clinical trial… Full Summary
ACET Adicet Bio	$9.53 -0.1%	Q4 2026	ADI-212 treatment of patients with metastatic castration-resistant prostate cancer	Phase 1	8/27/2026 - Initiation Adicet Bio, Inc. announced that The Company plans to initiate Phase 1 enrollment in patients with m… Full Summary
COCP Cocrystal Pharma	$1.23 -0.8%	LATE 2026	CDI-988 For Pandemic Norovirus and Coronavirus		9/9/2026 - Results Cocrystal Pharma, Inc announced that the Preliminary efficacy results expected in late 2026 or ea… Full Summary
PRLD Prelude Therapeutics	$4.67 -8.3%	Q4 2026	PRT13722 Oral KAT6A Selective Degrader		9/10/2026 - Enrollment Update Prelude Therapeutics Incorporated announced that the Company expects to begin enrolling patients in… Full Summary
CAMP CAMP4 Therapeutics	$4.34 +0.2%	Q4 2026	CMP-002 treat a broad range of genetic diseases		9/10/2026 - Clinical Trial CAMP4 Therapeutics Corporation announced that the Company anticipates initiation of the clinical tr… Full Summary
NUVB Nuvation Bio	$6.30 -3.4%	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
BLTE Belite Bio	$175.07 -4.4%	February 12, 2027	Tinlarebant In Stargardt Disease		8/11/2026 - PDUFA Date Belite Bio, Inc announced that The FDA has set a Prescription Drug User Fee Act (PDUFA) date of Feb… Full Summary
CGEM Cullinan Therapeutics	$21.00 -1.5%	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
BMRN BioMarin Pharmaceutical	$65.51 +1.7%	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
NTLA Intellia Therapeutics	$11.93 -2.3%	March 10, 2027	onvo-z hereditary angioedema	BLA	9/8/2026 - PDUFA Date Intellia Therapeutics, announced that the PDUFA target action date of March 10, 2027 Full Summary
MRK Merck & Co., Inc.	$144.68 -1.9%	March 22, 2027	ENFLONSIA™ In Infants Born During or Entering Their First RSV Season	sBLA	8/6/2026 - PDUFA Date Merck announced that The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, dat… Full Summary
PMVP PMV Pharmaceuticals	$1.44 +4.7%	Q1 2027	rezatapopt in patients with advanced solid tumors	NDA	10/24/2025 - NDA Filing PMV Pharmaceuticals, announced that Full Summary
STOK Stoke Therapeutics	$29.34 -1.9%	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
ABEO Abeona Therapeutics	$5.48 -5.4%	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
TEVA Teva Pharmaceutical Industries	$36.34 -1.4%	Q1 2027	Ecopipam To Treat Pediatric Patients With Tourette Syndrome	NDA	8/19/2026 - PDUFA Date Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd announced that the U.S.… Full Summary
DYN Dyne Therapeutics	$18.42 -4.0%	Q1 2027	DYNE-101 Designed to enable targeted muscle tissue delivery with the goal of reducing toxic DMPK RNA in the nucleus		9/8/2026 - Top-line data Dyne Therapeutics, Inc. announced that the Topline data from the ACHIEVE REC are on track for Q1 20… Full Summary
PHVS Pharvaris	$37.51 -0.6%	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
ORGO Organogenesis	$1.53 -2.5%	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
AXSM Axsome Therapeutics	$211.12 +0.2%	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
BBIO BridgeBio Pharma	$72.50 -4.7%	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
BMY Bristol Myers Squibb	$63.76 -1.0%	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
NBTX Nanobiotix	$37.60 +2.6%	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
KOD Kodiak Sciences	$32.87 -2.7%	Q2 2027	KSI-101 in patients with MESI		8/6/2026 - Top-line data Kodiak Sciences Inc. announced that the topline clinical data release anticipated in 2Q 2027 Full Summary
EYPT Eyepoint Pharmaceuticals	$4.25 -2.1%	H1 2027	DURAVYU In patients with non-proliferative diabetic retinopathy (NPDR).		8/17/2026 - NDA submission EyePoint, Inc. announced that the potential FDA New Drug Application submission planned for 1H 2027 Full Summary
VOR Vor Biopharma	$22.34 -3.9%	H1 2027	telitacicept Sjögren's Disease		9/8/2026 - Top-line results Vor Bio announced Topline results from the 24-week primary endpoint remain expected in the first ha… Full Summary
OPTH Optimi Health	$4.50 +3.4%	H1 2027	psilocybin-assisted therapy for Major Depressive Disorder		9/10/2026 - Trial Initiation Optimi Health Corp announced that the trial is planned to be initiated in the first half of 2027 Full Summary
LBRX LB Pharmaceuticals	$46.25 -3.0%	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 Aura Biosciences	$6.99 -2.9%	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
IONS Ionis Pharmaceuticals	$55.65 -0.7%	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
EYPT Eyepoint Pharmaceuticals	$4.25 -2.1%	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
OPTH Optimi Health	$4.50 +3.4%	LATE 2027	psilocybin-assisted therapy for Major Depressive Disorder		9/10/2026 - Dose Update Optimi Health Corp. announced that the dosing expected to be complete by the end of 2027. Full Summary

More FDA Event Resources from MarketBeat

FDA Event Stage Terminology & Abbreviation Guide

• 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

Sign in to your free account to enjoy these benefits

• In-depth profiles and analysis for 20,000 public companies.
• Real-time analyst ratings, insider transactions, earnings data, and more.
• Our daily ratings and market update email newsletter.

Sign in to your free account to enjoy all that MarketBeat has to offer.

• Sign In
• Create Account

Your Email Address:

Email Address Required

Your Password:

Password Required

Log In Email Me a Login Link

---

or

Sign in with Facebook Sign in with Google

Forgot your password?

Your Email Address:

Please enter your email address.

Please enter a valid email address

Choose a Password:

Please enter your password.

Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character.

Create My Account (Free)

---

or

Sign in with Facebook Sign in with Google

By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.