{"entity":{"id":"cogent-biosciences","kind":"company","name":"Cogent Biosciences","aka":[],"tldr":"Cogent Biosciences makes bezuclastinib, a pill that blocks a mutated protein called KIT. It has positive late-stage results in a rare gut tumour called GIST and in systemic mastocytosis, a disease of overactive immune cells, and US decisions on approval are due in November and December 2026.","summary":"Cogent Biosciences is a Waltham, Massachusetts and Boulder, Colorado company developing precision therapies for genetically defined diseases. Its lead candidate, bezuclastinib, is a selective tyrosine kinase inhibitor of KIT D816V and other KIT mutations. In November 2025 it reported positive top-line SUMMIT results in non-advanced systemic mastocytosis (FDA Breakthrough Therapy designation). In the phase 3 PEAK trial in second-line gastrointestinal stromal tumours (GIST), bezuclastinib plus sunitinib gave a median progression-free survival, assessed by blinded independent central review, of 16.5 months against 9.2 months for sunitinib alone (hazard ratio 0.50), a result the company describes as highly statistically significant. By August 2026 the FDA had accepted the GIST application with priority review and a decision date of 30 November 2026, set a decision date of 30 December 2026 for non-advanced systemic mastocytosis, and received a third application, for advanced systemic mastocytosis, submitted on 30 June 2026. Preclinical programmes include a JAK2 V617F mutant-selective inhibitor, a pan-KRAS(ON/OFF) inhibitor, and selective ErbB2 (HER2), PI3K-alpha and FGFR2 inhibitors. Cogent (formerly Unum Therapeutics) trades on Nasdaq as COGT and reported a pro forma cash balance of 865.9 million US dollars in August 2026.","asOf":"2026-10-29","links":[{"label":"Official website","url":"https://www.cogentbio.com/"},{"label":"Q2 2026 results, PEAK data and FDA decision dates (SEC exhibit)","url":"https://www.sec.gov/Archives/edgar/data/1622229/000119312526341315/cogt-ex99_1.htm"},{"label":"Pipeline and publications","url":"https://www.cogentbio.com/pipeline-publications/"},{"label":"Q3 2025 results and business update (SEC exhibit)","url":"https://www.sec.gov/Archives/edgar/data/1622229/000119312525261797/cogt-ex99_1.htm"},{"label":"December 2020 public offering 8-K (SEC)","url":"https://www.sec.gov/Archives/edgar/data/1622229/000119312520308501/d72504d8k.htm"}],"tags":[],"related":[],"cancers":["sarcoma"],"sections":["targeted-therapy"],"technologies":["kinase-inhibitors"],"targets":["kit","her2","kras","pik3ca","fgfr2"],"drugs":["bezuclastinib","cgt4859"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct05186753","nct04996875","nct06777316"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["PEAK figures (data cut-off 30 September 2025), the decision dates and the June 2026 filing come from Cogent's second-quarter 2026 results release of 10 August 2026. No approval had been reported in the company's SEC filings up to 29 October 2026; whether the FDA has acted since was not checked. Cogent's SEC filings from January 2025 to October 2026 show no acquisition or merger. APEX results in advanced systemic mastocytosis were not read."],"hq":"Waltham, MA","country":"US","companyType":"biotech","website":"https://www.cogentbio.com/","ticker":"COGT","stage":"public","investors":[],"funding":[]},"route":"/companies/cogent-biosciences/","neighbours":{"cancer":[{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"}],"section":[{"id":"targeted-therapy","kind":"section","name":"Targeted Therapy","route":"/fronts/targeted-therapy/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"fgfr2","kind":"target","name":"FGFR2","route":"/targets/fgfr2/"},{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"},{"id":"kit","kind":"target","name":"KIT","route":"/targets/kit/"},{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"},{"id":"pik3ca","kind":"target","name":"PIK3CA / PI3K-alpha","route":"/targets/pik3ca/"}],"drug":[{"id":"bezuclastinib","kind":"drug","name":"Bezuclastinib","route":"/drugs/bezuclastinib/"},{"id":"cgt4859","kind":"drug","name":"CGT4859","route":"/drugs/cgt4859/"}],"trial":[{"id":"nct04996875","kind":"trial","name":"(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis","route":"/trials/nct04996875/"},{"id":"nct05208047","kind":"trial","name":"(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors","route":"/trials/nct05208047/"},{"id":"nct05186753","kind":"trial","name":"(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis","route":"/trials/nct05186753/"},{"id":"nct06777316","kind":"trial","name":"A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors","route":"/trials/nct06777316/"}]}}