Home/Pipeline/Bezuclastinib

Bezuclastinib

NonAdvanced Systemic Mastocytosis (NonAdvSM)

NDA SubmittedFDA accepted NDA with PDUFA date Dec 30, 2026

Key Facts

Indication
NonAdvanced Systemic Mastocytosis (NonAdvSM)
Phase
NDA Submitted
Status
FDA accepted NDA with PDUFA date Dec 30, 2026
Company

About Cogent Biosciences

Cogent Biosciences is advancing a pipeline of precision therapies targeting genetically driven diseases, with its lead program bezuclastinib having an FDA New Drug Application accepted with a PDUFA target action date of December 30, 2026. The company operates a discovery organization in Boulder, Colorado, and is led by experienced pharmaceutical executives with expertise in oncology and hematology. Cogent's strategy focuses on improving upon existing drugs with limitations and creating breakthroughs for diseases where adequate solutions are lacking.

View full company profile

About Cogent Biosciences

Cogent Biosciences is advancing a pipeline of precision therapies targeting genetically driven diseases, with its lead program bezuclastinib having an FDA New Drug Application accepted with a PDUFA target action date of December 30, 2026. The company operates a discovery organization in Boulder, Colorado, and is led by experienced pharmaceutical executives with expertise in oncology and hematology. Cogent's strategy focuses on improving upon existing drugs with limitations and creating breakthroughs for diseases where adequate solutions are lacking.

View full company profile

About Cogent Biosciences

Cogent Biosciences is advancing a pipeline of precision therapies targeting genetically driven diseases, with its lead program bezuclastinib having an FDA New Drug Application accepted with a PDUFA target action date of December 30, 2026. The company operates a discovery organization in Boulder, Colorado, and is led by experienced pharmaceutical executives with expertise in oncology and hematology. Cogent's strategy focuses on improving upon existing drugs with limitations and creating breakthroughs for diseases where adequate solutions are lacking.

View full company profile