Cogent Biosciences Announces Planned 2025 Milestones for Bezuclastinib and Emerging Portfolio of Selective and Potent Targeted Therapeutics

Core Insights - Cogent Biosciences anticipates 2025 to be a transformational year, with plans to report top-line results from three registration-directed studies of bezuclastinib and submit its first New Drug Application (NDA) by the end of the year [2][9] Milestones for 2025 - The company plans to report top-line results from the SUMMIT trial for Non-Advanced Systemic Mastocytosis (NonAdvSM) in July 2025 [8][9] - Top-line results from the pivotal Phase 3 PEAK trial for gastrointestinal stromal tumors (GIST) are expected by the end of 2025 [4][9] - The APEX trial for Advanced Systemic Mastocytosis (AdvSM) will report results in the second half of 2025 [9] - An Expanded Access Program (EAP) for bezuclastinib will be initiated in Q1 2025 for eligible SM and GIST patients [5] Pipeline Development - The ongoing Phase 1 trial of CGT4859, a selective FGFR2 inhibitor, aims to explore safety and tolerability in patients with FGFR mutations [6] - The company plans to submit IND applications for CGT4255, a selective ErbB2 inhibitor, and CGT6737, a potent allosteric inhibitor of PI3Kα, during 2025 [7][10] Financial Position - Cogent Biosciences has a strong balance sheet, positioning the company well for its transition into a commercial-stage entity [2]