FDA Calendar 2025

A PDUFA (Prescription Drug User Fee Act) date is the FDA's deadline to make a decision on a drug application. It matters because biotech stocks can move 30-100%+ on FDA decisions. PDUFA dates create binary events where approval can double a stock, while rejection (Complete Response Letter) can cause 50%+ declines. Investors closely track these dates for trading opportunities and risk management.

You can track FDA approval dates through FDA.gov's official calendar, company investor relations pages, clinical trial databases (ClinicalTrials.gov), biotech news sites (FierceBiotech, Endpoints News), and specialized services like our FDA Calendar above. Companies typically announce PDUFA dates in press releases when they file their NDA/BLA applications.

By the PDUFA date, the FDA must issue one of three responses: 1) Approval - the drug can be marketed, 2) Complete Response Letter (CRL) - rejection requiring additional data, clinical trials, or manufacturing changes, or 3) Extension - FDA requests more time for review (rare). The FDA typically announces decisions on or before the PDUFA date, often during trading hours.

A Complete Response Letter (CRL) is an FDA rejection of a drug application. The letter outlines deficiencies that must be addressed before approval - this could include additional clinical trials, manufacturing changes, labeling updates, or safety concerns. CRLs typically cause 30-70% stock declines. Companies can resubmit after addressing FDA concerns, creating new PDUFA dates 6-12 months later.

This depends on your risk tolerance. Buying before offers higher upside (50-100%+) but risks major losses on rejection. Buying after positive decisions offers lower upside (10-30%) but confirms the drug works. Conservative investors buy post-approval, while aggressive traders position before catalysts. Consider using options for defined-risk binary bets, and never risk more than 5% of your portfolio on a single PDUFA event.

Key FDA designations that accelerate approval include: Priority Review (6 months vs 10 months standard), Breakthrough Therapy (intensive FDA guidance, rolling review), Fast Track (rolling review, earlier FDA interactions), and Accelerated Approval (based on surrogate endpoints). These designations indicate FDA urgency and often increase approval probability. Stocks typically rally 15-40% on receiving these designations.

FDA Advisory Committee recommendations are highly predictive. Historically, drugs with positive AdCom votes (majority favor approval) receive FDA approval 85%+ of the time. However, the FDA is not bound by AdCom recommendations. Negative AdCom votes are strongly predictive of rejection. AdCom meetings typically occur 2-3 months before PDUFA dates and can cause 20-50% stock movements.

NDA (New Drug Application) is for small molecule drugs - traditional pills and tablets made through chemical synthesis. BLA (Biologics License Application) is for biologics - larger, complex molecules derived from living cells, including antibodies, vaccines, and cell therapies. The review process is similar, but biologics face additional manufacturing complexity. Both have PDUFA dates and similar approval timelines.