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Cogent Biosciences Announces Planned 2025 Milestones for Bezuclastinib and Emerging Portfolio of Selective and Potent Targeted Therapeutics
• Plan to report top-line results from registration-directed SUMMIT trial in NonAdvSM patients in July 2025 • Plan to report top-line results from pivotal
About this update from Cogent Biosciences, Inc.
[{"type":"text","content":"• Plan to report top-line results from registration-directed SUMMIT trial in NonAdvSM patients in July 2025 • Plan to report top-line results from pivotal PEAK Phase 3 trial in 2nd-line GIST patients by end of 2025 • Plan to report top-line results from registration-directed APEX trial in AdvSM patients in 2H 2025 • Company to present at J.P. Morgan 43rd annual healthcare conference tomorrow, Tuesday, January 14 at 7:30 a.m. PT /10:30 a.m. ET WALTHAM, Mass. and BOULDER, Colo., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today highlighted the company’s key 2025 milestones ahead of its presentation at J.P. Morgan’s 43rd annual healthcare conference. “2025 will be a transformational year at Cogent Biosciences,” said Andrew Robbins, President and Chief Executive Officer. “During the year, we plan to report top-line results from all three registration-directed bezuclastinib studies, and if successful, move forward with our first New Drug Application (NDA) submission by the end of 2025. With both SUMMIT and PEAK enrollment finishing several months ahead of schedule, we are confident that physicians and patients are highly aware of bezuclastinib’s potential and are also eagerly awaiting these clinical trial results. We believe bezuclastinib could change the lives of thousands of patients fighting SM and GIST and has the potential to be the first potent, CNS-sparing, selective KIT mutant inhibitor. In addition, we continue to advance our pipeline of novel small molecule programs, including an ongoing Phase 1 study of our novel FGFR2 inhibitor, CGT4859, and plan to file INDs for both our ErbB2 and PI3Kα programs during the year. With a strong balance sheet, we are well positioned to prepare Cogent for our evolution into a commercial-stage company.” In 2025, the Company plans to achieve the following milestones: Bezuclastinib – Systemic Mastocytosis (SM) Report top-line results in July 2025 from the SUMMIT trial. SUMMIT is a registration-directed, global, randomized, placebo-controlled trial of bezuclastinib in patients with Non-Advanced Systemic Mastocytosis (NonAdvSM).Report top-line results during the second half of 2025 from the APEX trial. APEX is a registration-directed, global, open-label trial of bezuc...