Cogent Biosciences

COGT

Market cap $5.91B

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

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

WALTHAM, Mass. and BOULDER, Colo.

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.

- 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.

WALTHAM, Mass. and BOULDER, Colo.

– 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

Cogent Biosciences, Inc. maintains a Buy rating as bezuclastinib demonstrates blockbuster potential in GIST and systemic mastocytosis (SM) indications. Bezuclastinib nearly doubled median PFS in 2L GIST (PEAK trial), supporting a high peak market share assumption despite competitive pressures. COGT's sum-of-the-parts valuation yields a fair value of $26.54/share, with current cash reserves likely sufficient to reach commercial launch, though dilution risk remains.

WALTHAM, Mass. and BOULDER, Colo., April 01, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the completion of the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. Based on the positive results from the PEAK trial, the bezuclastinib NDA was submitted under the FDA's Real-Time Oncology Review (RTOR) program, which is intended to enable a more streamlined review process. Bezuclastinib was also granted Breakthrough Therapy Designation as a treatment for GIST earlier this year.

UBS analysts have outlined a set of high-conviction healthcare ideas where they believed the market was underappreciating earnings durability and the scale of upcoming catalysts, focusing on stocks backed by differentiated views and proprietary insights. In biotechnology, they identified Cogent Biosciences (NASDAQ:COGT) as their top pick, arguing the company offered scarcity value as a SMID-cap advancing two late-stage, potentially blockbuster assets.