Sagimet Biosciences Doses First Patient in Phase 3 Denifanstat Acne Trial

Sagimet Biosciences (SGMT) said the first patient has been dosed in AURORA, its pivotal U.S. Phase 3 trial of denifanstat for moderate to severe acne in patients aged 12 and older. The study is designed to support a potential U.S. New Drug Application. The trial expects to enroll about 800 patients, including roughly 450 adolescents aged 12 to 17. Participants will receive denifanstat 50 mg once daily or placebo for 12 weeks, followed by a 40-week open-label extension for eligible patients. The program follows positive Phase 3 results from partner Ascletis' study in China, where the drug met all primary and secondary endpoints over 12 weeks, with extension data showing improvements at 52 weeks. Sagimet expects topline AURORA results in the second half of 2027. SGMT traded at $9.75, down 2.40%.