08:54 AM EDT, 04/01/2026 (MT Newswires) -- Cogent Biosciences ( COGT ) said Wednesday it submitted a new drug application to the US Food and Drug Administration for bezuclastinib to treat gastrointestinal stromal tumors in patients previously treated with imatinib.

The application was submitted under the FDA's Real-Time Oncology Review program based on positive results from a phase 3 trial, the company said.

Cogent Biosciences ( COGT ) said the bezuclastinib and sunitinib combination demonstrated a median progression-free survival of 16.5 months compared with 9.2 months for sunitinib monotherapy, and reduced the risk of disease progression or death by 50%.

The company said it expects to present full phase 3 trial results in H1 and plans to initiate a phase 2 study of the combination in first-line gastrointestinal stromal tumor patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib.