Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

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

GlobeNewsWire • Sep 15, 2026

Cogent Biosciences: 3 NDAs Create A Time-To-Market Moat

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.

Seeking Alpha • Aug 27, 2026

Cogent Biosciences (COGT) May Find a Bottom Soon, Here's Why You Should Buy the Stock Now

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.

Zacks Investment Research • Aug 13, 2026

Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2026 Financial Results

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.

GlobeNewsWire • Aug 10, 2026

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

GlobeNewsWire • Jun 30, 2026

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.

Seeking Alpha • Jun 14, 2026

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 • Jun 12, 2026

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 • Jun 12, 2026

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 • May 30, 2026

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 • May 28, 2026