CGEM PDUFA decision: Saturday, February 27, 2027

…pproval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027. Cullinan Therapeutics is eligible to receive $30 million and $100 million in milestone payments upon second-line and first-line U.

Dates are sourced from official registries and filings and can change — estimated dates (marked ~) slip routinely. This page updates automatically when the source registry moves the date. Research information only, not investment advice.