PDUFA Calendar 2026: FDA Drug Approval Dates

The 2026 FDA calendar features some of the most anticipated drug approvals in recent years, from Eli Lilly's oral GLP-1 receptor agonist orforglipron to breakthrough gene therapies and first-in-class mechanisms. This page tracks every confirmed PDUFA target action date for 2026, scored by the ODIN v2.1 probability engine.

A PDUFA date (Prescription Drug User Fee Act date) is the FDA's deadline to make a regulatory decision on a new drug application. These binary events routinely cause 20–70% stock moves in biotech equities, making them critical catalysts for event-driven investors.

Key 2026 PDUFA Dates

DateTickerDrugIndicationTAODIN
2026-02-25OTSKFINQOVI + VenetoclaxAcute Myeloid LeukemiaOncologyBasic
2026-02-28REGNDupixentAllergic Fungal RhinosinusitisImmunologyBasic
2026-02-28ASNDNavepegritideAnemia of CKDHematologyBasic
2026-03-06BMYDeucravacitinibUlcerative ColitisImmunologyPro
2026-03-20RYTMImcivreeHypothalamic ObesityEndocrinologyPro
2026-03-24GSKLinerixibatCholestatic Pruritus (PBC)HepatologyPro
2026-03-25LLYOrforglipronType 2 DiabetesEndocrinologyPro
2026-03-28RCKTKresladiDanon DiseaseGene TherapyPro
2026-03-29LNTHGa68-edotreotideGEP-NETs ImagingOncologyPro
2026-04-05DNLITividenofusp alfaMPS-IIIA (Sanfilippo)Rare DiseasePro
2026-05-15TVTXPivlicaftor PotentiatorCystic FibrosisPulmonologyPro
2026-06-20ACLXCytisiniclineSmoking CessationCNSPro
2026-07-01KURATipifarnibHRAS-Mutant HNSCCOncologyPro
2026-07-07VERAAtaciceptIgA NephropathyNephrologyPro

Data updated daily. Free users see ODIN tier assignments. Upgrade to Pro for full probability scores. See data sources →

Why 2026 Matters for Biotech Investors

2026 is shaping up as a landmark year for FDA approvals. The pipeline includes several potential blockbusters: orforglipron could become the first oral GLP-1 for diabetes (a market projected at $100B+), multiple gene therapies are approaching approval, and several oncology breakthroughs are in late-stage review. The patent cliff hitting Big Pharma is driving aggressive M&A activity around catalyst-stage biotechs.

How to Use This Calendar

The interactive calendar below lets you filter PDUFA dates by therapeutic area, ODIN tier, and catalyst type. Each catalyst shows the ODIN v2.1 approval probability score, which uses 45 featureed signals trained on 2,210 historical FDA decisions. Learn more about how ODIN works or explore the verified track record.

For trading strategies around these dates, see the PDUFA Runup Strategy — a validated framework for capturing pre-catalyst appreciation. Browse the biotech glossary if you encounter unfamiliar terms.

Frequently Asked Questions

What are the biggest PDUFA dates in 2026?

Key dates include Eli Lilly's orforglipron (March 25), Regeneron's Dupixent for AFRS (February 28), GSK's linerixibat (March 24), and pivlicaftor for CF (May 15). These are scored TIER_1 by ODIN.

How many PDUFA dates are scheduled for 2026?

Approximately 25-30 confirmed dates as of February 2026, with more expected as new NDAs/BLAs are accepted.

How does ODIN score 2026 catalysts?

ODIN v2.1 uses 45 featureed signals across regulatory designations, manufacturing risk, therapeutic area history, and sponsor track record. Learn more →

Where can I track PDUFA dates for free?

PDUFA.bio offers a free tier with all dates, tier assignments, and basic info. Pro subscribers get full scores, alerts, and exports. See pricing →

What are the biggest PDUFA dates in Q1 2026?

Q1 2026 highlights include REGN Dupixent for allergic fungal rhinosinusitis (Feb 28), LLY orforglipron oral GLP-1 for diabetes (Mar 25), GSK linerixibat for cholestatic pruritus (Mar 24), and LNTH Ga68-edotreotide for neuroendocrine tumor imaging (Mar 29). See the full Q1 oncology PDUFA breakdown →

Which PDUFA stocks have the highest approval odds?

ODIN TIER_1 catalysts have historically shown a 93.6% approval rate. In 2026, several upcoming PDUFAs are scored TIER_1 including large-cap sBLA expansions and drugs with Breakthrough Therapy or Priority Review designations. See ODIN's verified track record →

How often does the FDA miss PDUFA dates?

The FDA meets its PDUFA target action date over 90% of the time and frequently acts early. For example, VNDA's Bysanti was approved on Feb 20, 2026 — one day before its Feb 21 PDUFA date. Early action typically signals a clean review with no outstanding issues.

Important: PDUFA.BIO is not the FDA. ODIN scores are ML model outputs, not financial advice. All investing carries risk. Read full disclaimer →

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FDA PDUFA Calendar 2026 — Biotech Catalyst Dates

Complete calendar of upcoming FDA PDUFA dates, Phase 2/3 clinical trial readouts, and biotech earnings. Click any event for ODIN AI approval scoring. Tracking 50 PDUFAs, 186 readouts, and 27 earnings.

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FDA catalyst intelligence powered by the ODIN v1108 scoring engine. Trained on 2,200+ PDUFA decisions & 2,000+ phase readouts (2015–2026).

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PDUFA.BIO is the data-driven FDA PDUFA calendar and biotech catalyst calendar built for quantitative investors. Track upcoming PDUFA dates for 2026, FDA drug approval action dates, and biotech earnings dates in a unified, filterable calendar. Learn what a PDUFA date is and how the ODIN AI scoring engine generates FDA approval probability scores. Use the biotech catalyst screener to filter by ticker, therapeutic area, and ODIN tier. Explore the PDUFA runup strategy and verify ODIN's accuracy on the verified track record page. Browse our biotech glossary and catalyst research hub.

DISCLAIMER: PDUFA.BIO is not affiliated with, endorsed by, or connected to the U.S. Food & Drug Administration (FDA) or any government agency. The name "PDUFA" refers to the Prescription Drug User Fee Act and is used descriptively. This site does not provide financial, investment, legal, or medical advice. PDUFA.BIO is not a registered investment advisor, broker-dealer, or financial planner. Probability scores are generated by machine-learning models based on historical data and publicly available information. These scores are statistical estimates, not predictions or guarantees of FDA action or securities performance. Past approval rates do not guarantee future results.

RISK WARNING: Investing in biotechnology and pharmaceutical securities involves substantial risk, including the risk of total loss of capital. Binary catalyst events (such as PDUFA dates) can result in extreme price volatility. You should not invest money you cannot afford to lose. Always consult with a qualified financial advisor before making investment decisions. PDUFA.BIO, its operators, contributors, and affiliates accept no responsibility or liability for any losses arising from use of this site.

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PDUFA Calendar 2026 — Track all upcoming FDA PDUFA dates and biotech catalysts in one place. Learn what a PDUFA date is, explore the ODIN scoring engine, and verify predictions on the track record. Browse the biotech glossary and research hub.