Cogent Biosciences Files New Drug Application To FDA For Bezuclastinib In Patients With Gastrointestinal Stromal Tumors

Cogent Biosciences, Inc. (Nasdaq: COGT) has submitted a New Drug Application (NDA) to the FDA for bezuclastinib, targeting patients with Gastrointestinal Stromal Tumors (GIST) who have previously been treated with imatinib. This submission follows positive results from the PEAK trial and utilizes the FDA's Real-Time Oncology Review program for expedited evaluation. Additionally, bezuclastinib received Breakthrough Therapy Designation earlier this year.