2026 Biotech Catalyst Calendar: 1 Sourced Events

A biotech catalyst is a known event — like an FDA decision (PDUFA date), a clinical trial readout, an advisory committee meeting, or a major conference presentation — that can move a drug company’s stock price sharply up or down. Catalysts resolve uncertainty about a drug’s commercial future, which is why biotech stocks routinely move 20-60% on catalyst days.

A PDUFA (Prescription Drug User Fee Act) date is the calendar deadline by which the FDA has committed to making an approval decision on a new drug application. The outcome is binary: the FDA either approves the drug or issues a Complete Response Letter (CRL) explaining why it was not approved. PDUFA dates are typically 10 months after submission, or 6 months for Priority Review drugs.

Each calendar is held to a 45-day review window and shows its own age at the top of the page, so you never have to guess how current it is. Readout entries are matched against ClinicalTrials.gov before publication; FDA decision dates publish only when we have found the company filing that states the date. We do not refresh daily, and we no longer claim to.

Yes. Every calendar, every readout entry, and every plain-English summary is free. A paid Premium tier unlocks real-time alerts, the advanced biotech screener, and unlimited use of the Trial Translator tool. Note that we withhold FDA decision dates we cannot trace to the filing that states them, so this calendar is deliberately shorter than others.

Other calendars list dates. ClinicalInvestor adds AI-generated, plain-English explanations of what each catalyst means for investors, what to expect from the readout, historical context, and a significance score (must-watch, important, notable). It is built for retail biotech investors who want context, not just a list.