08:30 AM EDT, 07/07/2025 (MT Newswires) -- Cogent Biosciences ( COGT ) said Monday that a trial evaluating bezuclastinib in patients with non-advanced systemic mastocytosis achieved statistical significance across all primary and key secondary endpoints.

Patients treated with bezuclastinib showed a superior mean change in total symptom score of -24.3 points versus -15.4 points for placebo at 24 weeks, the company said.

The majority of treatment emergent adverse events were of low grade, the company said.

Cogent said it is on track to submit its first new drug application to the US Food and Drug Administration for bezuclastinib in non-advanced systemic mastocytosis by the end of 2025.

Cogent shares were up 16% in recent premarket activity.