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Cogent Biosciences is a 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 advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has already exhibited promising early clinical activity and safety in a Phase 1/2 trial in patients with advanced GIST and also has the potential to fill an unmet need for patients living with Systemic Mastocytosis.
Cogent Biosciences Announces Phase 3 PEAK Trial in Patients with Gastrointestinal Stromal Tumors (GIST) Has Completed Enrollment and Advanced Past Interim Futility Analysis
413 patients enrolled in PEAK Phase 3 GIST trial, exceeding enrollment target; top-line results expected by end of 2025 PEAK interim futility analysis completed with no changes to study Registration-directed SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) now on track to complete
Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2024 Financial Results
SUMMIT, PEAK and APEX registration-directed clinical trial enrollment remains on track; topline results expected from all three studies in 2025 Ended 2Q 2024 with $390 million, sufficient to fund operations into 2027 WALTHAM, Mass. and BOULDER, Colo., Aug.
Cogent Biosciences Announces Positive FDA Meeting and Alignment on MS2D2, a Novel Patient Reported Outcome Measure for the SUMMIT Trial
Enrollment in SUMMIT Part 2 remains on track for completion in Q2 2025 with top-line results expected by end of 2025 WALTHAM, Mass. and BOULDER, Colo., June 27, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for
Cogent Biosciences Announces Additional Clinical Data from Part 1 of its Ongoing SUMMIT Trial Evaluating Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM)
Patients treated with 100 mg bezuclastinib showed substantial reduction in their most severe symptoms and mast cell reactions Reductions were shown in all individual MS2D2 symptoms across domains and objective reduction in skin lesions corresponding with symptomatic improvement WALTHAM, Mass.