20 October 2025 - Detailed results from bezuclastinib’s positive SUMMIT trial evaluating bezuclastinib in patients with non-advanced systemic mastocytosis planned for presentation at upcoming scientific conference this year.

Cogent Biosciences today announced that the US FDA has granted breakthrough therapy designation for bezuclastinib in non-advanced systemic mastocytosis patients previously treated with avapritinib as well as in patients with smoldering systemic mastocytosis; populations with no currently approved standard of care.

Read Cogent Biosciences press release