COGT - Cogent Biosciences, Inc.
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
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.
- JAK2 V671F poster presentation showcases potential best-in-class properties, including improved selectivity compared with currently approved JAK inhibitors -
-- 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 –
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.
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.
Cogent Biosciences (NASDAQ: COGT - Get Free Report) and GT Biopharma (NASDAQ: GTBP - Get Free Report) are both medical companies, but which is the superior stock? We will compare the two companies based on the strength of their dividends, earnings, risk, valuation, analyst recommendations, profitability and institutional ownership. Analyst Ratings This is a breakdown of recent
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.
RTW Investments added 4,124,755 Cogent Biosciences shares in the fourth quarter; the estimated trade size was $115.95 million. Meanwhile, the quarter-end stake value increased by $219.88 million, reflecting both trading and price appreciation.
Kynam Capital sold 1,720,949 shares of Cogent Biosciences in the fourth quarter; the estimated transaction value was $48.38 million. Meanwhile, the position's quarter-end value changed by $105.74 million, reflecting both trading and share price movements.
Boone Capital Management sold 945,042 shares of Cogent Biosciences in the fourth quarter. As a result, the quarter-end position value decreased by $13.57 million.
Cogent Biosciences jumps after FDA accepts bezuclastinib NDA for treating non-advanced SM, with a decision due by Dec. 30, 2026.