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...
WALTHAM, Mass. and BOULDER, Colo., March 16, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined...
Bezuclastinib mean TSS reduction deepens to –32.0 points at 48 weeks of treatment with further improvement shown across all measured symptoms 99% of patients achieve >50% reduction in serum tryptase...
SUMMIT NDA for bezuclastinib in patients with NonAdvSM submitted in December 2025; APEX NDA submission for bezuclastinib in patients with AdvSM on track for 1H 2026 PEAK NDA initiated for bezuclastinib...
WALTHAM, Mass. and BOULDER, Colo., Feb. 10, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined...
- Cogent will submit the PEAK New Drug Application (NDA) under previously announced RTOR designation; on track to complete NDA submission in April 2026 WALTHAM, Mass. and BOULDER, Colo., Jan....
- PEAK trial first ever study to demonstrate statistical significance over an active comparator in GIST patients, with bezuclastinib plus sunitinib combination demonstrating mPFS of 16.5 months and ORR...
New Drug Application (NDA) for NonAdvSM submitted in December 2025, NDA submission for AdvSM on track for 1H 2026 NDA submission for GIST on track for April 2026; bezuclastinib has the potential to...
WALTHAM, Mass. and BOULDER, Colo., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined...
WALTHAM, Mass. and BOULDER, Colo., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined...