PDUFA dates and FDA catalyst events
BiotechSign tracks 57 upcoming PDUFA (Prescription Drug User Fee Act) target action dates for FDA decisions on new drug applications. PDUFA dates represent the FDA's deadline to act on an NDA (New Drug Application) or BLA (Biologics License Application) submission. These dates are among the most significant binary catalysts in biotech investing — an approval or rejection can move a stock 50% or more in a single session. This calendar is updated daily from FDA and SEC sources.
Not financial advice. PDUFA dates involve binary FDA outcomes that can result in total loss of investment. Biotech stocks carry extreme risk. Always conduct your own due diligence and consult a qualified financial advisor. Source: BiotechSigns (biotechsign.com).
PDUFA stands for the Prescription Drug User Fee Act. A PDUFA date is the FDA's self-imposed deadline to complete its review of a New Drug Application (NDA) or Biologics License Application (BLA). Under PDUFA, the FDA commits to a 10-month standard review or 6-month Priority Review action date from the date of filing acceptance. The FDA meets its PDUFA deadline roughly 90% of the time.
The FDA issues a Complete Response Letter (CRL) if it cannot approve the drug, or an approval letter granting marketing authorization. The agency may also approve with labeling restrictions, a Risk Evaluation and Mitigation Strategy (REMS), or request additional post-marketing studies. The PDUFA date is the last possible action date — the FDA can and often does act earlier.
Once the FDA accepts a drug application for filing, it sets the PDUFA date at 10 months from the 60-day filing acceptance date (or 6 months for Priority Review). Companies disclose PDUFA dates in SEC filings and press releases. The FDA publishes its own PDUFA calendar. BiotechSign aggregates these from public sources and updates them daily.
An Advisory Committee (ADCOM) is an independent expert panel the FDA convenes to publicly review an application and provide a non-binding vote. Not every drug gets an ADCOM — the FDA requests one when it wants outside perspective on complex risk-benefit questions. ADCOM meetings typically occur 1–3 months before the PDUFA date. The FDA does not always follow the ADCOM vote but historically approves drugs with positive votes at a high rate.
Yes. The FDA can extend its review by three months if it issues a Complete Response Letter for a major deficiency, or if the sponsor submits a major amendment during the review window. Companies must disclose PDUFA date changes in SEC filings. BiotechSign updates dates when new disclosures are detected.
BiotechSign pulls PDUFA dates from SEC filings (8-Ks, 10-Qs, press releases), the FDA's published PDUFA calendar, and ClinicalTrials.gov. Dates are mapped to publicly traded tickers and updated daily. Use the watchlist filter above to focus on tickers you track.
Not financial advice. Data by Guerilla Finance Inc. for informational purposes only. Always conduct your own due diligence.