Cogent Biosciences Files New Drug Application To FDA For Bezuclastinib In Advanced Systemic Mastocytosis

Cogent Biosciences, Inc. (Nasdaq: COGT ), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in Advanced Systemic Mastocytosis (AdvSM). The submission is based on positive clinical data from the APEX pivotal trial.