FDA Calendar 2026

This calendar covers four event types: PDUFA dates (FDA decision deadlines for drug approvals), Phase 3 clinical trial readouts, Phase 2 clinical trial readouts, and FDA Advisory Committee (AdCom) meetings. Together these represent every major regulatory catalyst that moves biotech stock prices.

A New Drug Application (NDA) is filed for small-molecule drugs — chemically synthesized compounds like pills and tablets. A Biologics License Application (BLA) is filed for biologic products — large, complex molecules made from living cells, including monoclonal antibodies, gene therapies, and vaccines. Both go through the same PDUFA review timeline, but biologics face additional manufacturing scrutiny.

An Advisory Committee meeting is a public hearing where an independent panel of outside experts reviews clinical trial data and votes on whether a drug should be approved. While the FDA is not bound by the vote, it follows AdCom recommendations roughly 75-80% of the time. A favorable AdCom vote often triggers a significant stock rally before the final PDUFA decision.

Phase 2 and Phase 3 readout dates are estimated from ClinicalTrials.gov primary completion dates, company earnings call guidance, and press releases. When the exact date is unknown, we show a quarter (Q1, Q2) or half-year (H1, H2) estimate. Dates can shift if enrollment is slow or the trial design changes.

On or before the PDUFA date, the FDA issues one of three decisions: Approval (the drug can be marketed), a Complete Response Letter (CRL) requesting additional data or changes, or in rare cases, a delayed action. An approval typically triggers a 20-50% stock jump for small-cap biotechs. A CRL often causes a 40-80% decline. The company can then address the FDA's concerns and resubmit, resetting the PDUFA clock.