COGT PDUFA decision: Monday, November 30, 2026

…oved hematologic tolerability.   Anticipated Upcoming Milestones • Potential FDA approval of bezuclastinib in GIST – PDUFA date of November 30, 2026 • Potential FDA approval of bezuclastinib in NonAdvSM – PDUFA date of December 30, 2026 • Submit Investigation

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.