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 participate in a fireside chat at the Guggenheim Healthcare Innovation Conference on November 10, 2026. The Boston session begins at 7:30 a.m. ET, with a live webcast and a replay available through the company’s website.
Separately, on October 26, 2026, the compensation committee approved inducement awards for six new employees: options to purchase 22,000 shares and 16,500 restricted stock units. Both awards vest over four years, subject to continued employment. The options have a 10-year term and an exercise price equal to the stock’s closing price on the grant date.
Cogent Biosciences (COGT) reported FDA acceptance of its New Drug Application for bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM), with a PDUFA target action date of June 29, 2027.
The FDA indicated there is currently no plan to hold an advisory committee meeting and has not identified potential review issues. The NDA is supported by the pivotal APEX trial, in which bezuclastinib showed a 65% overall response rate by mIWG-MRT-ECNM criteria, including 57% of patients achieving CR, CRh or PR, and an 81% response rate by pure pathological response criteria as of March 31, 2026. Twelve‑month progression‑free survival was 79% and twelve‑month overall survival was 87%, with median PFS and OS not yet mature.
Additional NDAs for bezuclastinib in NonAdvSM and GIST remain under FDA review with PDUFA dates of December 30, 2026 and November 30, 2026, respectively. Cogent also detailed active U.S. expanded access programs for SM and GIST and disclosed option grants for 39,300 shares and 33,600 RSUs to nine new employees under its 2020 Inducement Plan.
Cogent Biosciences (Nasdaq: COGT) reported Q2 2026 results and business updates, highlighting three New Drug Applications for bezuclastinib in GIST and systemic mastocytosis, with FDA priority reviews in GIST and PDUFA dates of November 30 and December 30, 2026 for GIST and NonAdvSM, respectively, and an AdvSM NDA submitted June 30.
The Phase 3 PEAK trial in imatinib-resistant/intolerant GIST showed a 50% reduction in risk of progression or death (HR 0.50) and mPFS of 16.5 vs 9.2 months for sunitinib, plus higher ORR (46% vs 26%). The APEX AdvSM trial reported 65% ORR among 68 evaluable patients. Cash, equivalents and marketable securities were $792.3 million at June 30, 2026, with pro forma cash of $865.9 million including $73.6 million ATM proceeds, funding operations into late 2028. Q2 R&D expenses were $70.8 million, G&A $31.8 million, and net loss $96.4 million.
Cogent Biosciences (Nasdaq: COGT) submitted a New Drug Application to the FDA for bezuclastinib in advanced systemic mastocytosis (AdvSM), supported by the pivotal APEX trial.
APEX showed a 65% ORR by mIWG criteria and 81% ORR by PPR, durable PFS/OS, strong biomarker reductions, and a generally well-tolerated safety profile. Cogent also highlighted active expanded access programs and small inducement equity grants to new employees.
Cogent Biosciences (Nasdaq: COGT) reported preclinical data for its novel JAK2 V617F mutant-selective inhibitor CGT1145 at the 2026 EHA Congress. The candidate showed >100x selectivity over JAK2 wild-type and JAK1/3 isoforms, with high oral bioavailability, low clearance across species, and an IND filing planned in 2026.
Cogent Biosciences (Nasdaq: COGT) reported detailed data from the pivotal APEX trial of bezuclastinib in advanced systemic mastocytosis (AdvSM) at EHA 2026.
Bezuclastinib showed a 65% ORR per mIWG criteria, 81% ORR per PPR criteria, strong mast cell burden reductions, durable PFS/OS, and a generally favorable safety profile. An APEX NDA filing is planned for June 2026.
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.