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, Inc. (Nasdaq: COGT) generates frequent news flow as a biotechnology company developing precision therapies for genetically defined diseases. Its updates often center on the clinical and regulatory progress of bezuclastinib, a selective tyrosine kinase inhibitor designed to inhibit KIT D816V and other KIT exon 17 mutations associated with systemic mastocytosis and advanced gastrointestinal stromal tumors (GIST).
News for COGT commonly includes clinical trial milestones from the pivotal SUMMIT, APEX and PEAK studies. SUMMIT evaluates bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM), APEX in Advanced Systemic Mastocytosis (AdvSM), and PEAK in imatinib-resistant or intolerant GIST in combination with sunitinib. Press releases have highlighted positive top-line results, detailed efficacy and safety data, and plans for New Drug Application (NDA) submissions to the U.S. Food and Drug Administration.
Investors and followers of COGT can also expect regulatory and designation announcements, such as Breakthrough Therapy Designation for bezuclastinib in specific NonAdvSM populations, as well as updates on Expanded Access Programs for eligible GIST and SM patients. Financial and corporate news appears regularly, including equity and convertible note offerings, cash runway commentary, and participation in major healthcare investor conferences like the J.P. Morgan Healthcare Conference and the Jefferies Global Healthcare Conference.
In addition, Cogent issues news on its early-stage pipeline, including a selective and potent FGFR2/3 inhibitor in Phase 1/2 and discovery programs targeting ErbB2, PI3Kα, KRAS and JAK2. For readers tracking COGT, this news page provides an organized view of trial readouts, regulatory plans, financing events and scientific presentations that shape the company’s development trajectory. Bookmark this feed to monitor Cogent’s ongoing disclosures about its precision oncology and hematology programs.
Cogent Biosciences (Nasdaq: COGT) submitted an NDA to the FDA on April 1, 2026 for bezuclastinib in imatinib‑resistant GIST under the FDA’s RTOR program and with prior Breakthrough Therapy designation.
Pivotal Phase 3 PEAK data showed a 50% reduction in risk (HR 0.50, 95% CI 0.39–0.65), median PFS 16.5 vs. 9.2 months, and ORR 46% vs. 26% versus sunitinib; overall survival remains immature.
Cogent Biosciences (NASDAQ: COGT) announced FDA acceptance of its New Drug Application for bezuclastinib in NonAdvanced Systemic Mastocytosis with a PDUFA target action date of December 30, 2026. The FDA indicated no planned advisory committee and identified no review issues.
Cogent cited positive, highly statistically significant SUMMIT pivotal trial results through 48 weeks showing sustained symptomatic improvement, favorable safety for chronic use, evidence of disease modification, and benefit in high‑need populations. Separate NDA submissions for bezuclastinib in GIST (RTOR; Breakthrough Therapy Designation) and AdvSM remain on track for April 2026 and H1 2026, respectively.
Cogent Biosciences (Nasdaq: COGT) reported additional SUMMIT trial data for bezuclastinib in NonAdvanced systemic mastocytosis showing durable, deepening benefit through 48 weeks. Key results: mean Total Symptom Score (TSS) change of -32.0 (56% improvement), 99% achieved ≥50% serum tryptase reduction and 83.3% normalization, and clinically meaningful BMD gains at week 24.
The company also disclosed inducement equity grants totaling 24,000 stock options and 21,000 RSUs dated Feb 25, 2026.
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.