COGT News & Events

Cogent Biosciences announced it has submitted its new drug application, or NDA, to the FDA for bezuclastinib in Advanced Systemic Mastocytosis. The submission is based on clinical data from the APEX pivotal trial.

Cogent Biosciences announced detailed clinical data from the primary analysis of the PEAK Phase 3 trial of bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors, GIST, who have received prior treatment with imatinib. The presentation titled Primary Results of the Phase 3 Peak Study of Bezuclastinib + Sunitinib vs Sunitinib Monotherapy in Advanced Gastrointestinal Stromal Tumors will be presented. Key highlights: Bezuclastinib combination is first treatment ever to demonstrate statistically significant advantage against active comparator in GIST patients; median PFS of 16.5 months versus 9.2 months for bezuclastinib combination compared to sunitinib alone; Bezuclastinib combination provides clear PFS benefit regardless of primary or secondary KIT mutations; Mean duration of treatment estimated at 21.4 months for patients receiving bezuclastinib combination; Bezuclastinib combination well tolerated with no unique risks observed with the combination when compared to the known safety profile of sunitinib; Priority Review granted following FDA acceptance of NDA for bezuclastinib combination in GIST patients who previously received imatinib; PDUFA date scheduled for November 30, 2026

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.