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) will present new data at the European Hematology Association (EHA) 2026 Congress in Stockholm, June 11-14, 2026.
Highlights include a pivotal APEX trial oral presentation in Advanced Systemic Mastocytosis, an AdvSM poster, and a preclinical JAK2 V617F poster on CGT1145.
Cogent Biosciences (Nasdaq: COGT) provided a business update and reported Q1 2026 results. Key items: bezuclastinib NDAs under FDA review, Phase 3 PEAK pivotal GIST data selected for oral presentation at ASCO May 30, 2026, FDA set a PDUFA date of Dec 30, 2026 for NonAdvSM, and cash, cash equivalents and marketable securities of $866.4 million expected to fund operations into 2028.
Q1 results: R&D $75.4M, G&A $28.2M, net loss $97.4M. Pipeline and IND/Phase 1 plans continue through 2026.
Cogent Biosciences (Nasdaq: COGT) announced that positive Phase 3 PEAK trial results for bezuclastinib plus sunitinib in prior‑imatinib GIST will be presented orally at the 2026 ASCO Annual Meeting in Chicago on May 30, 2026.
Top‑line results were reported in November 2025 and an NDA was submitted under the RTOR program in March 2026. Cogent plans to initiate a Phase 2 trial this quarter for first‑line exon 9 GIST patients naive or recently started on imatinib.
Cogent Biosciences (Nasdaq: COGT) will present preclinical data at the AACR Annual Meeting 2026 in San Diego, April 17–22.
Key posters: CGT1263 (pan-KRAS(ON)) shows >500x selectivity for KRAS vs HRAS/NRAS, sustained pERK inhibition, robust antitumor activity and limited skin suppression; an IND submission is expected later this year. CGT4255 (EGFR-sparing ErbB2) shows >100-fold EGFR selectivity, best-in-class CNS penetration potential, activity against key HER2 mutations, and preclinical synergy with HER2 ADCs; Phase 1 is ongoing.
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.