COGT News & Events

Cogent Biosciences announced that the FDA has accepted its new drug application, or NDA, for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors, or GIST, who have received prior treatment with imatinib. The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act target action date of November 30. In addition, the FDA communicated that at this time, there is no plan to hold an advisory committee, nor have they identified any potential review issues.

Cogent Biosciences announced that preclinical data from the Company's KRAS and ErbB2 pipeline programs will be presented during poster sessions at the American Association for Cancer Research, AACR, Annual Meeting 2026 taking place in April 17-22 in San Diego, CA. Title: Characterization of CGT1263, a KRAS inhibitor clinical candidate with selectivity for mutant KRAS over HRAS and NRAS. preclinical poster highlights Cogent's internally developed pan-KRAS(ON) inhibitor with greater than500x selectivity for KRAS over HRAS and NRAS. Overall, these findings suggest CGT1263 could provide an advantage for patients, enabling higher dosing designed to elicit a more profound molecular response. Investigational New Drug enabling studies are ongoing with an IND submission expected later this year. Title: Preclinical characterization of CGT4255, an EGFR sparing, pan-mutant HER2 clinical development candidate with potential best-in-class brain penetration. Cogent's EGFR-sparing, brain-penetrant ErbB2 inhibitor includes potent coverage of key mutations inadequately addressed by currently approved therapies. Activating mutations in the ErbB2 gene have been identified in multiple cancers and demonstrate a tumorigenic role similar to that of ErbB2 amplification.

Cogent Biosciences announced the completion of the submission of its new drug application to the FDA for bezuclastinib in patients with Gastrointestinal Stromal Tumors who have received prior treatment with imatinib. Based on the positive results from the PEAK trial, the bezuclastinib NDA was submitted under the FDA's Real-Time Oncology Review program, which is intended to enable a more streamlined review process. Bezuclastinib was also granted Breakthrough Therapy Designation as a treatment for GIST earlier this year.