Biotech Catalyst Types | PDUFA, Clinical Trials, FDA Decisions | CatalystAlert

Understanding Biotech Catalyst Types

Biotech catalysts are key events that can significantly impact a company's stock price. CatalystAlert tracks multiple types of catalysts to help investors stay informed about upcoming opportunities and risks in the biotechnology sector.

PDUFA Dates

PDUFA (Prescription Drug User Fee Act) dates are FDA target action dates for drug approval decisions. These are among the most important catalysts for biotech investors as they represent binary events with significant stock price implications.

Clinical Trial Results

Phase 1, 2, and 3 clinical trial results provide critical data on drug safety and efficacy. Phase 3 readouts are particularly significant as they often determine whether a drug will be submitted for FDA approval.

FDA Advisory Committee (AdCom) Meetings

AdCom meetings bring together external experts to review drug applications and provide recommendations to the FDA. While not binding, AdCom votes are often followed by the FDA and can signal approval or rejection.