Cogent Biosciences, Inc. COGT

Cogent Biosciences has delivered very strong share price gains over the past five years, so the obvious question for you now is whether that move is backed up by what sits on its balance sheet. After a powerful run and fresh regulatory progress, investors are increasingly asking how today’s valuation stacks up against the company’s book value. Over the past 5 years the stock is up about 2.7x. This puts real pressure on the question of whether the current price is still in line with what its...

Cogent Biosciences (COGT) just received U.S. Food and Drug Administration acceptance of its New Drug Application for bezuclastinib in Advanced Systemic Mastocytosis, with no advisory committee planned and no review issues flagged. Despite the FDA momentum, Cogent Biosciences shares have eased recently, with the 30 day share price return down 13.3% and the 90 day share price return down 17.4%. However, the 1 year total shareholder return of 137.1% suggests earlier optimism around its broader...

Cogent Biosciences recently announced that the FDA has accepted its New Drug Application for bezuclastinib in Advanced Systemic Mastocytosis, set a PDUFA action date of June 29, 2027, and indicated no current plans for an advisory committee or identified review issues. The filing builds on pivotal APEX trial data showing clinically meaningful responses and durable clinical activity in Advanced Systemic Mastocytosis, while parallel NDA reviews in NonAdvanced SM and GIST point to a broader...

NDA supported by positive results from the APEX pivotal trial demonstrating clinically meaningful responses and evidence of disease modification in patients with AdvSM PDUFA target action date set for June 29, 2027 WALTHAM, Mass. and BOULDER, Colo., Sept. 15, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has accep

Cogent Biosciences Inc. (NASDAQ:COGT) is one of the 10 affordable biotech stocks to buy right now. On June 30, Cogent Bioscience Inc. (NASDAQ:COGT) disclosed that it filed a New Drug Application for bezuclastinib, a drug for the treatment of Advanced Systemic Mastocytosis. The application to the U.S. FDA is backed by encouraging clinical results from […]

Executives Set to Attend to Explore AI, Regulatory Shifts at Boston's Flagship MedTech GatheringBOSTON, July 06, 2026 (GLOBE NEWSWIRE) -- MEDevice Boston returns August 26–27, 2026 to the Thomas M. Menino Convention & Exhibition Center, connecting industry professionals with over 170 exhibitors to accelerate FDA-cleared medical device innovations. This year’s event features expanded programming and innovation-focused experiences designed to connect the industry's brightest minds. Registration is

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 APEX NDA is third submission for bezuclastinib in six months; PEAK and SUMMIT reviews ongoing and on track for anticipated Q4 2026 approval WALTHAM, Mass. and BOULDER, Colo., June 30, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology co

Cogent Biosciences, Inc. (NASDAQ:COGT) is one of the most promising healthcare stocks according to Wall Street analysts. On June 12, Cogent Biosciences, Inc. (NASDAQ:COGT) presented early-stage preclinical data for its experimental drug CGT1145 at the European Hematology Association Congress in Stockholm, Sweden. The company presented the drug candidate as a potentially more precise and better-tolerated […]

Cogent Biosciences (COGT) Bezuclastinib showed "rapid and deep" clinical benefit and met primary and

- JAK2 V671F poster presentation showcases potential best-in-class properties, including improved selectivity compared with currently approved JAK inhibitors - - Selective JAK V617F inhibitor, CGT1145, on track for IND in 2026 - WALTHAM, Mass. and BOULDER, Colo., June 12, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced preclinical data from its novel, potential be

-- 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 demonstrated a powerful effect on mast cell burden with 91% of patients achieving ≥50% reduction in variant allele frequency and 89% of patients achieving ≥50% reduction in bone marrow mast cells or clearance of aggregates – -- Bezuclastinib continues to demonstrate a favorable safet

Cogent Biosciences recently reported detailed primary analysis data from its PEAK Phase 3 trial, showing that bezuclastinib plus sunitinib significantly improved progression-free survival and objective response rates versus sunitinib alone in previously imatinib-treated GIST patients, with a safety profile consistent with known sunitinib risks. The combination has received FDA Priority Review with a November 30, 2026 PDUFA date, and Cogent has already launched new first-line GIST studies and...

Is COGT a good stock to buy? We came across a bullish thesis on Cogent Biosciences, Inc. on X.com by @seedy19tron. In this article, we will summarize the bulls’ thesis on COGT. Cogent Biosciences, Inc.’s share was trading at $34.81 as of June 1st. Cogent Biosciences (COGT) is a clinical-stage oncology company focused on KIT mutation-driven diseases, […]

This clinical-stage biotech develops precision genetic medicines for neurological and hepatic disorders via its PRISM platform.

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<0.0001) for bezuclastinib combination compared to sunitinib alone Bezuclastinib combination provides clear PFS benefit regardless of primary or secondary KIT mutations Mean duration of treatment estimated at 21.4 months for patients receiving bezuclastinib combination Bezuclastinib c

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 Bezuclastinib combination is first treatment ever to demonstrate statistically significant advantage against an active comparator in GIST patients; median PFS of 16.5 months versus 9.2 months (HR=0.50, CI: 0.39-0.65, p<0.0001) for bezuclastinib combination compared to sunitinib alone Full results