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Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited positive data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 800+ patients in single agent and combination dosing. Cogent has multiple NDAs pending review with the FDA, and pending regulatory approval, the company expects to launch bezuclastinib commercially in the United States in the second half of 2026.
Cogent Biosciences Announces Oral Presentation of Positive Phase 3 PEAK Trial in Gastrointestinal Stromal Tumors (GIST) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
WALTHAM, Mass. and BOULDER, Colo., April 21, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the results from the Phase 3 PEAK trial have been selected for
Cogent Biosciences Announces Poster Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2026
– Updated presentation on Cogent’s potent pan-KRAS(ON) inhibitor, CGT1263, showcasing its selectivity profile which could lead to reduction in skin toxicity associated with multi-RAS inhibitors – Updated presentation on Cogent’s brain penetrant ErbB2 inhibitor, CGT4255, with evidence of synergistic
Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)
Bezuclastinib NDA submitted under the FDA’s RTOR program based on positive results from Phase 3 PEAK trial; bezuclastinib previously granted Breakthrough Therapy Designation in GIST Bezuclastinib combination demonstrated 16.5 month mPFS and 46% ORR in imatinib-resistant GIST patients, dramatically
Cogent Biosciences Announces FDA Acceptance of New Drug Application for Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM)
NDA based on positive clinical results from the SUMMIT pivotal trial in which bezuclastinib demonstrated clear clinical benefit across all symptom domains WALTHAM, Mass. and BOULDER, Colo., March 16, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused

