PDUFA Dates November 2026

A PDUFA date is the FDA’s target deadline to complete its review of a drug application under the Prescription Drug User Fee Act. Approval, a Complete Response Letter, or a delay on this date is one of the largest single-day catalysts a biotech stock has. Dates below are extracted from company 8-K filings and official notices, with the source linked on every event.

• PDUFA decision AGIO Agios Pharmaceuticals, Inc. PDUFA target action date: Agios Pharmaceuticals, Inc. 2026-11-01
• PDUFA decision BBIO BridgeBio Pharma, Inc. PDUFA target action date: BridgeBio Pharma, Inc. 2026-11-27
• PDUFA decision RPRX Royalty Pharma plc PDUFA target action date: Royalty Pharma plc 2026-11-27
• PDUFA decision COGT Cogent Biosciences, Inc. PDUFA target action date: Cogent Biosciences, Inc. 2026-11-30
• PDUFA decision VRTX Vertex Pharmaceuticals Incorporated PDUFA target action date: Vertex Pharmaceuticals Incorporated 2026-11-30