Every major biotech catalyst from April through June 2026 — PDUFA dates, FDA Advisory Committee meetings, Phase 3 trial readouts, and conference schedules. All entries auto-generated from the live catalyst database and refreshed every Monday.
Q2 2026 (April–June) is one of the busiest FDA decision quarters of the year. PDUFA dates mark the FDA's self-imposed deadline to approve or reject a New Drug Application (NDA) or Biologics License Application (BLA). Missing a key catalyst date can mean missing a 40–200% move in a single session — in either direction.
This calendar aggregates every tracked catalyst across PDUFA decisions, Advisory Committee votes, Phase 3 trial data readouts, and major biotech conferences. Probability of Approval (PoA) scores use FDA historical approval rates by application type and designation. The database updates every Monday so this page reflects the latest data.
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Each row in the table represents a binary event — a date when a drug could be approved, rejected, or delayed. For biotech investors, these dates are the highest-volatility moments in a stock's lifecycle.
FDA's self-imposed target date to approve or issue a Complete Response Letter (CRL). The highest-stakes binary event for most small-cap biotechs.
Advisory Committee panel votes on whether a drug should be approved. The FDA follows AdCom recommendations the majority of the time.
Phase 3 trial data releases. Positive data can trigger NDA filing; failure can be catastrophic for single-asset biotechs. PoA scores for trials use Phase 3 historical success rates (~58%).
Historical Probability of Approval — an evidence-based base rate, not a prediction. NDA standard = 85%, NDA priority = 90%, orphan = 93%. A prior CRL reduces PoA by ~28%.
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Understanding what these dates mean is step one. Trading them profitably — position sizing for binary events, options strategies around IV crush, reading AdCom signals — is a different skill.
How to Trade PDUFA Dates: Strategy Guide →Don't Miss a Q2 Catalyst
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