Cogent Biosciences Inc.

7 days ago · globenewswire.com

NDA supported by positive results from the APEX pivotal trial demonstrating clinically meaningful responses and evidence of disease modification in patients with AdvSM

26 days ago · seekingalpha.com

Cogent Biosciences is positioned to commercialize bezuclastinib across three indications, leveraging a single precision molecule for multi-market entry. Positive pivotal data in GIST, NonAdvSM, and AdvSM underpin three NDAs, with regulatory decisions expected between late 2026 and early 2027. COGT's commercial infrastructure and $865.9M liquidity provide a runway through 2028, supporting launch and early commercialization activities.

1 month ago · zacks.com

Cogent Biosciences (COGT) witnesses a hammer chart pattern, indicating support found by the stock after losing some value lately. This coupled with an upward trend in earnings estimate revisions could mean a trend reversal for the stock in the near term.

1 month ago · globenewswire.com

On track for potential approval of bezuclastinib for GIST patients (PDUFA November 30) and NonAdvSM patients (PDUFA December 30) later this year; AdvSM New Drug Application submitted to FDA on June 30  Completed onboarding of expert cross-functional Cogent customer-facing team, including all field-based commercial and medical team members Strong pro forma cash balance of $865.9 million, sufficient to fund operations into late 2028 WALTHAM, Mass. and BOULDER, Colo.

3 months ago · globenewswire.com

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

3 months ago · globenewswire.com

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

3 months ago · globenewswire.com

-- 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 –

4 months ago · globenewswire.com

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

4 months ago · globenewswire.com

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.

5 months ago · globenewswire.com

- 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.