Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)
Cogent Biosciences announced that the FDA has accepted its New Drug Application for bezuclastinib in patients with advanced systemic mastocytosis (AdvSM). The application is supported by positive results from the APEX pivotal trial, which demonstrated clinically meaningful responses and evidence of disease modification.
Why it matters — FDA acceptance of the NDA moves bezuclastinib, a key pipeline candidate, one step closer to potential regulatory approval in AdvSM.