30 December 2025 - Cogent Biosciences today announced it has submitted its new drug application to the US FDA for bezuclastinib in non-advanced systemic mastocytosis. 

The submission is based on positive clinical data from the SUMMIT pivotal trial and follows the breakthrough therapy designation for bezuclastinib in patients with systemic mastocytosis and patients with non-advanced systemic mastocytosis who have received prior avapritinib.

Read Cogent Biosciences press release