FDA Calendar

Updated daily, the FDA calendar gives you insight into FDA actions on companies and upcoming actions the FDA is expected to take. Benzinga's FDA calendar shows historical FDA data, upcoming dates that companies will be impacted by the FDA and ranges of dates.

Exact Dates

Estimated Dates

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REGNSNYSNYNFRegeneron Pharmaceuticals Inc
Sanofi SA
Libtayo (cemiplimab)
Advanced Cervical Cancer
05/01/2025
9:35 AM
New Data

Regeneron Pharmaceuticals, Inc. announced new and updated data from its oncology and hematology portfolio will be shared at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 to June 3 in Chicago, IL.

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SRNESorrento Therapeutics Inc
SP-102 (SEMDEXA)
Sciatica Pain Management
05/01/2025
9:18 AM
Presentation

Scilex Holding Company announced an upcoming presentation of post-hoc analysis of the C.L.E.A.R. trial (Corticosteroid Lumbar Epidural Analgesia in Radiculopathy) interpreting clinical meaningfulness of safety and efficacy of SP-102 (SEMDEXA™) for the treatment of lumbosacral radicular pain (LRP) at the 27th Annual Meeting of American Society of Interventional Pain Physicians (ASIPP), May 15-17, 2025 in Orlando, FL.

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BCDABioCardia Inc
CardiAMP HF
For Ischemic Heart Failure
Phase 305/01/2025
9:11 AM
Enrollment Update

BioCardia, Inc. announced the first patient enrolled in the Phase III randomized procedure placebo-controlled double-blind CardiAMP HF II clinical trial of the Company's lead autologous cell therapy program for the treatment of heart failure at BayCare Morton Plant Hospital in Clearwater, Florida.

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REGNSNYSNYNFRegeneron Pharmaceuticals Inc
Sanofi SA
Dupixent (dupilumab)
Moderate-to-severe asthma
05/01/2025
9:09 AM
Abstract

Regeneron Pharmaceuticals, Inc. announced 24 abstracts on Dupixent® (dupilumab) clinical data and real-world analyses in respiratory diseases will be presented at the American Thoracic Society (ATS) International Conference 2025 being held from May 18 to 21 in San Francisco, California.

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LYELLyell Immunopharma, Inc.
IMPT-314
For the treatment of B-cell Lymphoma
Phase 1/205/01/2025
9:04 AM
Abstract

Lyell Immunopharma, Inc. announced that an abstract highlighting new clinical data from the Phase 1/2 trial of LYL314 (formerly IMPT-314) in large B-cell lymphoma will be presented as an oral presentation at the International Conference on Malignant Lymphoma (ICML) 2025 taking place in Lugano, Switzerland June 17-21, 2025.

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TTX-MC138
In Patients with Advanced Solid Tumors
05/01/2025
8:46 AM
Dose Update

EXCLUSIVE: TransCode Therapeutics Tells Benzinga 'A total of 13 patients treated with four escalating doses of TTX-MC138'

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ADILAdial Pharmaceuticals Inc
AD04
Alcohol Use Disorder (AUD)
05/01/2025
8:10 AM
Provided Update

EXCLUSIVE: Adial Pharmaceuticals Tells Benzinga 'New patent covers a treatment method for a broad spectrum of alcohol-related disorders, including additional conditions associated with alcohol use'

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ADILAdial Pharmaceuticals Inc
AD04
Alcohol Use Disorder (AUD)
05/01/2025
8:09 AM
Provided Update

EXCLUSIVE: Adial Pharmaceuticals Tells Benzinga Co. Expands Intellectual Property Portfolio With New US Patent Granted For Genetic-Based Treatment Of Alcohol And Opioid Use Disorders

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ATXSAstria Therapeutics, Inc.
Navenibart
For the Treatment of Hereditary Angioedema
Phase 1a05/01/2025
8:08 AM
Results

Astria Therapeutics, Inc. announced that results from a Phase 1a trial in healthy subjects supporting navenibart's potential to provide long-acting, safe, and effective attack prevention for hereditary angioedema (HAE) with dosing every 3 and 6 months have been published in the Annals of Allergy, Asthma & Immunology.

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FDMT4D Molecular Therapeutics Inc
4D-150
Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
Regenerative Medicine Advanced Therapy (RMAT) Designation05/01/2025
8:06 AM
Designation Grant

4D Molecular Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to 4D-150 for the treatment of diabetic macular edema (DME).

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EWEdwards Lifesciences Corp
SAPIEN
For Ultra transcatheter heart valve
05/01/2025
8:02 AM
FDA approved

Edwards Lifesciences announced today that the U.S. Food and Drug Administration (FDA) has approved its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for severe aortic stenosis (AS) patients without symptoms, marking the first FDA approval for TAVR in asymptomatic patients.

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OK-101
Treatment of Dry Eye Disease
Fast Track Designation05/01/2025
7:41 AM
Designation Grant

OKYO Pharma Limited announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to urcosimod for the treatment of neuropathic corneal pain (NCP).

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AVXLAnavex Life Sciences Corp
ANAVEX®3-71
For the treatment of neurodegenerative and neurodevelopmental disorders
Phase 205/01/2025
7:38 AM
Enrollment Update

Anavex Life Sciences Corp announced the successful completion of enrollment in its Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia (ANAVEX3-71-SZ-001, NCT06245213).

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BPMCBlueprint Medicines Corp
Avapritinib
For Indolent Systemic Mastocytosis
05/01/2025
7:21 AM
Provided Update

Blueprint Medicines Corporation provided corporate updates.

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BPTHBio-Path Holdings Inc
BP1001
For the treatment of acute myeloid leukemia (AML).
05/01/2025
7:19 AM
Provided Update

Bio-Path Holdings, Inc today reported the achievement of a third milestone from recent preclinical studies of BP1001-A that provide additional support for its potential as a treatment for obesity.

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PRTCPTCHFPureTech Health PLC
LYT-100
Idiopathic Pulmonary Fibrosis
05/01/2025
7:14 AM
Late Breaking Presentation

PureTech Health plc announced that the Company will deliver a late-breaking oral presentation at the upcoming American Thoracic Society (ATS) International Conference, taking place in San Francisco, California, from May 16-21, 2025.

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ALRNAileron Therapeutics Inc
LTI-03
In Idiopathic Pulmonary Fibrosis
05/01/2025
7:12 AM
Provided Update

Rein Therapeutics announced a collaboration for the integration of Qureight's deep-learning platform into Rein's planned Phase 2 trial of its lead asset LTI-03, a novel, multi-pathway, Caveolin-1-related peptide, for the treatment of idiopathic pulmonary fibrosis (IPF).

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What is an FDA Calendar?

Biotech investing is risk-fraught, as stocks are at the mercy of several catalysts – most of which are make-or-break events, aka binary events. A prudent investment strategy is to make informed decisions, being in the know of when to expect these events, how these events will pan out and the potential stock reaction in the run-up to the event and post the event.

Benzinga’s FDA calendar is a meaningfully designed, user friendly, dynamically updated and simplistic investment tool that is a ‘must-have’ for those looking to make money from the volatility that is typic of trading in biotech stocks.

The calendar lists down all key catalysts that can materially impact stocks, including:

  • PDUFA dates, or in other words FDA decision dates
  • Filing schedules for regulatory applications such as new drug application, or NDA, supplemental NDA, Biologic License Application, or BLA, supplemental BLA, Premarket Approval Application, or Premarket Notification 510(k), etc
  • FDA decisions (approvals/complete response letter/delay)
  • According to special statuses for treatment options, including orphan drug designation, rare disease designation, accelerated approval, priority review etc.
  • FDA’s Advisory Committee, or Adcom, meetings
  • Review meetings with FDA (pre-investigational new drug application meetings, end-of-phase meetings, Type A, Type B and Type C meetings)
  • Decisions by overseas regulatory agencies
  • Clinical data readouts
  • Presentation of data at various scientific conferences.

The calendar allows data screening, based on company names or tickers, events, date-wise or based on a date range. They are designed to serve as a ‘one-stop shop’ for data needs of investors, both existing and potential, to capitalize on the opportunities these catalysts throw up or cut the losses from an adverse development. 

What is a Catalyst?

A catalyst is any event/development that has the potential to swing the stock, usually in an appreciable way, in either direction, depending on how it materializes. 

Biotech Stock Movers

Regulatory actions and clinical readouts are stock-moving catalysts. The magnitude of the impact is usually disproportionate. Most clinical-stage biotechs, or companies which are yet to commercialize a product, do not generate revenues. The exceptions are those which may have out-licensed therapies-in-development to another company and as a result generate revenues in the form of licensing revenues. So, it will be years of investment (time money and efforts) into drug development, which usually takes about 10-15 years, on the promise of generating future returns.

A promising outcome in a particular stage of drug development is perceived by the market as an incremental step in bringing the company closer to that distant goal of marketing a potential blockbuster drug that could fetch it billions in revenues. This explains the huge positive move in a stock when a company reports a positive clinical readout.

Similarly, an unfavorable or a partially successful outcome could suggest all the investment the company may have made in the investigational therapy could go down the drain. Quite appropriately, investors punish the stock by selling it in droves.

PDUFA and Adcom events are binary events that have two outcomes, triggering moves in stock depending on which outcome materializes.

Stock Movers

Gainers

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Loser

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Frequently Asked Questions

Q

What is an FDA PDUFA date?

A

Prescription Drug User Fee Act date, in short, PDUFA date, refers to the date/period by which the FDA is mandated to give its verdict on the regulatory application filed by the sponsor company. The verdict can be an ‘approved’ decision, or a ‘complete response letter’ or a delay due to reasons specific to the company or extraneous to the company.

PDUFA was passed in the U.S. in 1992, which allows the FDA to collect fees from the sponsor company to fund the review process.

A CRL is issued by the FDA when it deems that the regulatory application is not complete in its current form. The deficiencies usually that lead to rejection could be the need for additional clinical studies to establish the efficacy and/or safety of the treatment option, problems with chemistry, manufacturing and controls, etc.

A delay in the review period may stem from the FDA needs additional time to review any additional data/information that may have been tabled subsequent to the submission of the regulatory application or the FDA’s inability to complete site inspections where the drug ingredients are being made etc.

The FDA may mention a specific date or a period (say Q1, Q2, Q3, Q4, first-half, second-half, the name of the month) as the timeline by which a decision will be given. If the FDA does not mention any timeline, the company may roughly calculate a timeline based on the data of filing the regulatory application. If the company doesn’t provide a timeline either, it is left to the investors to do the calculations.

Q

How long does an FDA approval take?

A

A regulatory application (NDA, sNDA, BLA, sBLA, etc.) is usually accepted for standard review or priority review. A standard review will mean the FDA has to hand out its verdict within 10 months of filing the application. The review window for a priority review gets shortened to six months.

Once a company files for a regulatory application, the FDA takes up to 60 days to respond with an ‘accepted for review’ or ‘refuse-to-file’ decision.

Q

How do you find FDA approvals?

A

A Catalysts Calendar is one way of tracking all the decisions in a single place. Usually, the FDA puts out a release and/or communicates to the company, which in turn will issue a press release.