Submission based on results of APEX pivotal trial which demonstrated bezuclastinib objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria with a well-tolerated safety profile for AdvSM patients

globenewswire.com - 2026-06-30 08:00:00

Cogent Biosciences is positioned to build a niche KIT-mutant franchise, leveraging bezuclastinib across three pivotal indications with strong clinical data. COGT holds $866.4 million in cash, supporting operations through 2028 and enabling launches in systemic mastocytosis and GIST, mitigating near-term financing risk. Bezuclastinib has demonstrated robust efficacy in nonadvanced and advanced systemic mastocytosis and second-line GIST, with three regulatory filings and positive pivotal trial results.

seekingalpha.com - 2026-06-14 09:13:38

-  JAK2 V671F poster presentation showcases potential best-in-class properties, including improved selectivity compared with currently approved JAK inhibitors -

globenewswire.com - 2026-06-12 08:01:00

-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an updated objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria –

globenewswire.com - 2026-06-12 08:00:00

Bezuclastinib combination is first treatment ever to demonstrate statistically significant advantage against active comparator in GIST patients; median PFS of 16. 5 months versus 9. 2 months (HR=0. 50, CI: 0. 39-0.

globenewswire.com - 2026-05-30 08:00:00

Bezuclastinib combination is first treatment ever to demonstrate statistically significant advantage against active comparator in GIST patients; median PFS of 16.5 months versus 9.2 months (HR=0.50, CI: 0.39-0.65, p

globenewswire.com - 2026-05-30 08:00:00

NDA acceptance with Priority Review builds upon previous assignment of Breakthrough Therapy Designation and Real-Time Oncology Review following Phase 3 PEAK results; PDUFA date set for November 30, 2026

globenewswire.com - 2026-05-28 08:00:00

WALTHAM, Mass. and BOULDER, Colo.

globenewswire.com - 2026-05-27 08:00:00

WALTHAM, Mass. and BOULDER, Colo., May 12, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced two presentations from the company's Advanced Systemic Mastocytosis (AdvSM) program, including an oral presentation highlighting the results of the APEX trial, as well as a poster presentation from its emerging JAK2 V617F program at the European Hematology Association (EHA) Congress being held in Stockholm, Sweden, June 11-14, 2026.

globenewswire.com - 2026-05-12 09:30:00

- Planning for dual launches of bezuclastinib in Systemic Mastocytosis and Gastrointestinal Stromal Tumors (GIST) - Pivotal data from Phase 3 PEAK trial in GIST patients selected for oral presentation at 2026 ASCO annual meeting  - Ended 1Q 2026 with $866.4 million in cash, sufficient to fund operations into 2028 WALTHAM, Mass. and BOULDER, Colo.

globenewswire.com - 2026-05-05 08:00:00

WALTHAM, Mass. and BOULDER, Colo.

globenewswire.com - 2026-04-21 08:00:00

– 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

globenewswire.com - 2026-04-17 08:00:00