Biotech Catalyst Calendar FAQ
What is a PDUFA date?
A PDUFA date is the FDA’s target deadline — set under the Prescription Drug User Fee Act — to complete its review of a New Drug Application or Biologics License Application. On or before this date the FDA typically approves the drug, issues a Complete Response Letter, or extends the review. Because the outcome is binary and scheduled, PDUFA dates are among the largest catalysts in biotech.
What is an FDA Advisory Committee (AdComm) meeting?
An AdComm is a public meeting where outside experts review a drug’s evidence and vote on whether its benefits outweigh its risks. The FDA is not bound by the vote but usually follows it, so the meeting — announced in the Federal Register — often moves the stock more than the approval decision itself.
What is a CHMP opinion?
The CHMP is the EMA committee that reviews new medicines for the EU. At its monthly meetings it adopts positive or negative opinions; a positive opinion is normally followed by a European Commission marketing authorisation within about 67 days. CHMP outcomes are the EU’s closest equivalent to a PDUFA decision.
What is a trial readout / primary completion date?
The primary completion date is when the last patient finishes the final visit for a trial’s primary endpoint, as registered on ClinicalTrials.gov. Top-line results usually follow weeks to months later. Registry dates are estimates until marked actual — companies revise them routinely.
Why do catalyst dates change?
Estimated dates slip constantly: trials enroll slower than planned, the FDA extends reviews (often after major amendments), and companies re-guide. That is why this calendar shows each date’s source and confidence, marks estimates with ~, and flags events whose registry date has moved — a changed date is information, not noise.
What is a Complete Response Letter (CRL)?
A CRL is the FDA’s formal rejection-for-now: the application cannot be approved in its present form. The letter states deficiencies; companies typically disclose it in an 8-K. Resubmissions restart a 2- or 6-month review clock.
Are these dates really free?
Yes. Catalyst dates on these pages are never paywalled and always cite a primary source. Paid tiers add tooling on top — Impact Forecasts, date-slip alerts, calendar sync and analytics — not access to the dates themselves.
Where does the data come from?
US events come from SEC 8-K filings, Federal Register notices and ClinicalTrials.gov; EU events from EMA CHMP agendas/highlights and the CTIS trial registry; earnings from a market-data feed. Every event links its source, and ingestion runs daily.
Every date on this page is free — forever.
A free account adds the interactive calendar with US/EU filters and watchlists. Investor (€19/mo) adds Impact Forecasts on each event, date-slip tracking and calendar sync (Google/Apple/Outlook). Pro adds the full analytics stack.