Cogent Biosciences Announces FDA Acceptance of New Drug Application for Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM)

Core Insights - The FDA has accepted Cogent Biosciences' New Drug Application (NDA) for bezuclastinib for patients with NonAdvanced Systemic Mastocytosis (NonAdvSM), with a target action date of December 30, 2026 [1] - The SUMMIT trial demonstrated significant clinical benefits of bezuclastinib across all symptom domains, indicating potential for sustained improvement over time [2] - The NDA submission for bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST) is on track for April 2026, and it has received Breakthrough Therapy Designation [3] Company Overview - Cogent Biosciences is focused on developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [4] - The company is also developing a portfolio of targeted therapies for serious, genetically driven diseases, including mutations in ErbB2, PI3Kα, KRAS, and JAK2 [4]