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 detailed PEAK Phase 3 data for bezuclastinib + sunitinib in imatinib-resistant or intolerant GIST at ASCO 2026. The combination achieved median PFS of 16.5 vs 9.2 months (HR=0.50, p<0.0001) and ORR of 46% vs 26% versus sunitinib alone, with benefit across KIT mutation subgroups and mean treatment duration of 21.4 months. Safety was generally consistent with sunitinib, though Grade 3+ ALT/AST increases were more frequent. The FDA granted Priority Review with a PDUFA date of November 30, 2026. Cogent also opened a 40-patient first-line exon 9 cohort and maintains U.S. expanded access programs.
Cogent Biosciences (Nasdaq: COGT) announced FDA acceptance of its NDA for bezuclastinib plus sunitinib in imatinib-treated GIST, with Priority Review and a PDUFA target date of November 30, 2026. The Phase 3 PEAK trial showed improved median PFS and higher ORR versus sunitinib alone, with a generally manageable safety profile and active U.S. expanded access programs.
Cogent Biosciences (Nasdaq: COGT) will participate in the Jefferies Global Healthcare Conference in New York on June 3, 2026 at 11:05 a.m. ET. A live webcast and 30‑day replay will be available on the company’s investor website.
The company also granted inducement equity awards under its 2020 Inducement Plan to six new employees on May 26, 2026. Awards total 25,500 stock options and 18,700 RSUs, with 4‑year vesting schedules, in line with Nasdaq Listing Rule 5635(c)(4).
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.