Welcome to our dedicated page for Cogent Biosciences news (Ticker: COGT), a resource for investors and traders seeking the latest updates and insights on Cogent Biosciences stock.
Cogent Biosciences develops precision therapies for genetically defined diseases, with recurring updates centered on bezuclastinib and KIT-driven disorders including Systemic Mastocytosis and Gastrointestinal Stromal Tumors (GIST). News commonly covers bezuclastinib clinical data from the SUMMIT and PEAK programs, U.S. FDA New Drug Application activity, medical-meeting presentations and related business updates.
Company announcements also describe preclinical oncology programs such as CGT1263, a KRAS inhibitor candidate, and CGT4255, a brain-penetrant ErbB2/HER2 inhibitor candidate. Financial-result releases and capital updates address cash resources, at-the-market equity activity and Nasdaq inducement equity awards.
Cogent Biosciences (Nasdaq: COGT) reported Q4 and full-year 2025 results and a business update on Feb 17, 2026. Key regulatory milestones: SUMMIT NDA for bezuclastinib in NonAdvSM submitted, PEAK NDA for second-line GIST under RTOR initiated, and APEX NDA for AdvSM on track for 1H 2026.
Clinical highlights include PEAK mPFS 16.5 vs 9.2 months (HR=0.50; p<0.0001) and APEX objective response rates of 57% (mIWG) and 80% (PPR). Cash, cash equivalents and marketable securities were $900.8 million at year‑end, positioned to fund operations into 2028.
Cogent Biosciences (Nasdaq: COGT) announced multiple posters presenting bezuclastinib SUMMIT trial data in nonadvanced systemic mastocytosis at the 2026 AAAAI Annual Meeting in Philadelphia, Feb 27–Mar 2, 2026.
Posters are scheduled Feb 28, 2026, 9:45–10:45am ET in Convention Center, Ground Level, Hall A, covering expanded results, biomarkers, symptom burden, patient experience, subgroup analyses, and correlations with objective measures. The company disclosed it submitted an NDA for bezuclastinib in NonAdvSM in Dec 2025 and holds Breakthrough Therapy Designation.
Cogent Biosciences (Nasdaq: COGT) announced that the FDA granted Breakthrough Therapy Designation for bezuclastinib combined with sunitinib for patients with GIST after prior imatinib. The designation is based on PEAK trial results showing a 50% reduction in risk of progression or death (HR 0.50, 95% CI 0.39–0.65) and mPFS of 16.5 months vs. 9.2 months for sunitinib alone. The combination showed no new safety risks versus known sunitinib profile. Cogent is on track to complete its PEAK NDA submission under RTOR in April 2026, plans a PEAK full-data presentation in H1 2026, and expects a mid-2026 Phase 2 trial for first-line exon 9 GIST patients.
Cogent Biosciences (Nasdaq: COGT) announced FDA agreement to accept its NDA for bezuclastinib + sunitinib for imatinib‑resistant GIST under the Real‑Time Oncology Review (RTOR) program. The Phase 3 PEAK trial showed a 50% reduction in risk of progression or death (HR 0.50, 95% CI 0.39–0.65), mPFS 16.5 months vs 9.2 months, and ORR 46% vs 26% versus sunitinib. Cogent will initiate RTOR immediately and expects to complete the NDA submission in April 2026. Full PEAK results will be presented in H1 2026 and a Phase 2 first‑line exon 9 trial is planned for mid‑2026.
Cogent Biosciences (NASDAQ: COGT) outlined key 2026 commercial and clinical milestones for bezuclastinib and its precision therapies pipeline.
Planned regulatory and clinical milestones include NDA acceptance for NonAdvSM by end-February 2026, an NDA submission for GIST in April 2026, an NDA submission for AdvSM in 1H 2026, and presentations of pivotal trial data (SUMMIT, PEAK, APEX) at major medical meetings in 1H 2026. The company targets a commercial launch of bezuclastinib in 2H 2026 if approved. Pipeline actions include IND submissions in 2026 for a pan-KRAS(ON) inhibitor and a selective JAK2 V617F inhibitor. Cogent reported a cash balance of ~ $900 million entering 2026 and noted active expanded access programs and a new SVP, Sales hire.
Cogent Biosciences (Nasdaq: COGT) announced that Andrew Robbins, President and CEO, will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on January 13, 2026 at 8:15 a.m. PT / 11:15 a.m. ET.
A live webcast will be available on the company’s Investors & Media page at investors.cogentbio.com, with a replay posted approximately two hours after the event and archived for up to 30 days.
Cogent Biosciences (Nasdaq: COGT) submitted a New Drug Application (NDA) to the FDA on Dec. 30, 2025 for bezuclastinib in NonAdvanced Systemic Mastocytosis based on positive SUMMIT pivotal-trial data.
The filing follows an FDA Breakthrough Therapy designation (Oct 2025) and 48-week SUMMIT results showing statistical significance across all primary and key secondary endpoints, symptom improvements across 11 reported domains, correlated reductions in serum tryptase, and a favorable safety/tolerability profile. Cogent plans two additional NDA submissions for bezuclastinib in GIST and Advanced SM in the first half of 2026 based on PEAK and APEX trial data.
Cogent Biosciences (NASDAQ: COGT) reported positive top-line results from the APEX Part 2 trial of bezuclastinib in advanced systemic mastocytosis (AdvSM) on Dec 8, 2025. Key outcomes: 57% ORR per mIWG criteria and 80% ORR per PPR; 89% of patients achieved ≥50% reductions in bone marrow mast cells and in serum tryptase; 91% achieved ≥50% reduction in KIT D816V VAF (n=43). Median time to response was 2.0 months; median duration of response is not yet mature. Safety: no discontinuations due to treatment-related adverse events and 14.8% required dose reductions. Cogent expects an NDA submission in 1H 2026 and will present detailed data in 1H 2026.
Cogent Biosciences (NASDAQ: COGT) reported full Part 2 SUMMIT results for bezuclastinib in nonadvanced systemic mastocytosis (NonAdvSM) presented at ASH on December 6, 2025. Data show clinically meaningful, statistically significant symptomatic and objective improvements at 24 weeks with continued deepening at 48 weeks.
Key facts: 65.4% achieved ≥30% TSS reduction at 24 weeks, 87.4% had ≥50% serum tryptase reduction at week 24, and 48-week follow-up showed 56.4% achieving ≥50% TSS reduction. Breakthrough Therapy designation was granted in October 2025 and an NDA is on track for December 2025 submission.
Cogent Biosciences (Nasdaq: COGT) will participate in the Jefferies Global Healthcare Conference in London on Wednesday, November 19, 2025 at 11:30 a.m. GMT (6:30 a.m. ET).
A live webcast will be available on Cogent’s Investors & Media page at investors.cogentbio.com, with a replay posted approximately two hours after the event and archived for up to 30 days.