09:12 AM EDT, 08/13/2026 (MT Newswires) -- Sagimet Biosciences ( SGMT ) said Thursday the US Food and Drug Administration cleared its investigational new drug application and issued a "Study May Proceed" letter for a Phase 3 trial of denifanstat in adolescents and adults with moderate to severe acne.

The trial is expected to enroll about 800 US patients, including 450 adolescents, and is on track to begin in H2, with dosing expected to start this year, the company said.

The 12-week randomized, double-blind period will be followed by a 40-week open-label extension to evaluate long-term safety, it added.

Sagimet Biosciences ( SGMT ) shares were up 1.5% in premarket activity.