PDUFA dates and AdCom meetings, tightly curated.
Upcoming FDA decisions for the most-watched names. We deliberately keep the list focused on dates that move stocks meaningfully — for full pipeline coverage, paid services like BiopharmCatalyst go deeper.
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What is a PDUFA date?
The Prescription Drug User Fee Act sets the deadline by which the FDA must complete its review of a New Drug Application. When a company submits a drug for approval, FDA assigns a PDUFA date — typically 6 months out for priority review or 10 months for standard review. The agency either approves, issues a Complete Response Letter (effectively a denial with feedback), or extends the date.
Stocks routinely move 20–60% on PDUFA outcomes. The dates are knowable in advance because companies disclose them in 10-Q filings and press releases.
What is an AdCom?
Advisory Committee meetings. FDA convenes external panels of clinicians and statisticians to review controversial or first-in-class drug applications. The committee votes on safety and efficacy questions, and FDA usually (though not always) follows the recommendation. AdCom days regularly produce 30%+ stock moves on the underlying.
Not all drug applications go through AdCom — only ~10% do, typically when there's clinical controversy or a novel mechanism.
Sourcing
Manually curated from company 10-Q filings, press releases, and FDA briefing documents. We focus on the 20–30 most-watched names where a date can move the stock by 10%+. Entries older than one week are auto-filtered out. The list updates whenever new dates surface.
The FDA does not publish a clean machine-readable PDUFA calendar. AdCom dates are public on FDA.gov; that auto-scrape is in the v1.4 backlog.
How to use this
- Hedge known events. If you hold a name with an upcoming binary event, the date here flags when implied volatility will collapse and how exposed you are.
- Spot crowded trades. Multiple PDUFA dates clustered in a quarter often mark sentiment peaks. The calendar makes the cluster visible.
- Plan around AdComs specifically. AdCom days have higher upside-and-downside variance than PDUFAs because the panel discussion is itself news.
Dates are best-known estimates and can be extended, withdrawn, or accelerated by FDA without notice. Always verify with the company's most recent SEC filings before trading.