Posted by Michael Wonder on 16 Mar 2026
Cogent Biosciences announces FDA acceptance of new drug application for bezuclastinib in patients with non-advanced systemic mastocytosis
16 March 2026 - NDA based on positive clinical results from the SUMMIT pivotal trial in which bezuclastinib demonstrated clear clinical benefit across all symptom domains.
Cogent Biosciences today announced that the US FDA has accepted its new drug application for bezuclastinib in patients with non-advanced systemic mastocytosis and assigned a PDUFA target action date of 30 December 2026. In addition, the FDA communicated that at this time, there is no plan to hold an advisory committee, nor have they identified any potential review issues.
