09:11 AM EST, 11/10/2025 (MT Newswires) -- Cogent Biosciences ( COGT ) said Monday that a phase 3 trial evaluating a combination of bezuclastinib and sunitinib in patients with imatinib-resistant or intolerant gastrointestinal stromal tumors, or GIST, showed higher progression free survival and objective response rates compared with sunitinib monotherapy.

The biotech firm said the combination achieved a median progression free survival of 16.5 months, compared with sunitinib monotherapy's progression free survival of 9.2 months. The combination achieved a 46% objective response rate, compared with 26% for the sunitinib monotherapy, the company added.

Cogent said it expects to file a new drug application with the US Food and Drug Administration for bezuclastinib in GIST in H1 of 2026.

Shares of Cogent climbed more than 120% pre-bell Monday.