09:08 AM EST, 01/26/2026 (MT Newswires) -- Cogent Biosciences ( COGT ) said Monday that the US Food and Drug Administration has granted breakthrough therapy designation for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors or GIST.

The designation is based on the company's Peak trial that demonstrated a "substantial and highly statistically significant clinical benefit" on the primary endpoint of progression-free survival, Cogent Biosciences ( COGT ) said.

The biotechnology firm said it plans to present full results from the Peak trial at a major medical meeting during H1 of 2026.

The company further expects to initiate a phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon nine mutations, Cogent Biosciences ( COGT ) said.

A breakthrough therapy designation is intended to expedite the review of medicines that treat a serious or life-threatening condition and have demonstrated potential clinical evidence showing "substantial improvement" over available therapies.

Shares of the company were up over 3% in recent Monday premarket activity.