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Cogent Biosciences Announces Anticipated 2026 Commercial and Clinical Milestones for Bezuclastinib and Precision Therapies Portfolio
New Drug Application (NDA) for NonAdvSM submitted in December 2025, NDA submission for AdvSM on track for 1H 2026NDA submission for GIST on track for April
About this update from Cogent Biosciences, Inc.
[{"type":"text","content":"New Drug Application (NDA) for NonAdvSM submitted in December 2025, NDA submission for AdvSM on track for 1H 2026NDA submission for GIST on track for April 2026; bezuclastinib has the potential to be the first new therapy for second-line GIST in over 20 yearsClinical data presentations from all three pivotal trials, PEAK, SUMMIT and APEX, expected at major medical meetings in 1H 2026Investigational New Drug (IND) applications expected in 2026 for potentially best-in-class pan-KRAS(ON) and selective JAK2 V617F inhibitorsStrong financial position with ~$900 million cash to begin 2026, sufficient to fund commercial launches and operations well into 2028Company to present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026 at 8:15 am PT/11:15 am ET WALTHAM, Mass. and BOULDER, Colo., Jan. 12, 2026 (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 2026 milestones ahead of its presentation at J.P. Morgan’s 44th annual healthcare conference. “2025 was marked by exceptional progress at Cogent Biosciences,” said Andrew Robbins, President and Chief Executive Officer. “We reported positive results from all three pivotal trials of bezuclastinib in patients with GIST and Systemic Mastocytosis, submitted our first NDA for bezuclastinib in patients with NonAdvSM based on the strength of the SUMMIT data, and put ourselves in a very strong financial position entering the new year. During 2026, we will transform Cogent into a fully integrated commercial stage company with plans to launch bezuclastinib in the second half of the year. In addition, we are investing for the future and plan to submit INDs in 2026 for both our pan-KRAS inhibitor and recently announced JAK2 V617F inhibitor. Our plans are supported by a highly experienced team with proven launch experience backed by a strong balance sheet. We are poised for success and extremely excited about the meaningful impact we can have for patients.” In 2026, Cogent plans to achieve the following milestones: Bezuclastinib Acceptance of the New Drug Application (NDA) for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM) by the end of February 2026Submit an NDA in April 2026 for bezuclastinib in patients with advan...