globenewswire.com · 30 jun

Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM)

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

seekingalpha.com · 14 jun

Cogent Biosciences: A Pre-Commercial Biotech With Commercial-Stage Leverage

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.

globenewswire.com · 12 jun

Cogent Biosciences Announces Preclinical Data from Novel JAK2 V617F Inhibitor at the 2026 European Hematology Association (EHA) Congress

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

globenewswire.com · 12 jun

Cogent Biosciences Announces Detailed Data from APEX Pivotal Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis at the 2026 European Hematology Association (EHA) Congress

-- 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 · 30 may

Cogent Biosciences Announces Detailed Clinical Data from PEAK Phase 3 Trial with Bezuclastinib in Combination with Sunitinib in Gastrointestinal Stromal Tumors (GIST) at 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

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 · 30 may

Cogent Biosciences Announces Detailed Clinical Data from PEAK Phase 3 Trial with Bezuclastinib in Combination with Sunitinib in Gastrointestinal Stromal Tumors (GIST) at 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

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 · 28 may

Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST

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 · 27 may

Cogent Biosciences Announces Participation in the 2026 Jefferies Global Healthcare Conference

WALTHAM, Mass. and BOULDER, Colo.