Sagimet Biosciences Doses First Patient In AURORA, Pivotal U.S. Phase 3 Clinical Trial Of Denifanstat In Adults With Moderate To Severe Acne

• With first patient dosed in AURORA Phase 3 clinical trial, Sagimet advances denifanstat's U.S. registrational program, building on positive Phase 3 clinical results in China from license partner Ascletis
• Pivotal trial designed to enroll approximately 800 U.S. patients, including 450 adolescents aged 12 and older
• If approved, denifanstat has the potential to address a significant unmet need among approximately 10 million Americans with moderate to severe acne
   

FOSTER CITY, Calif., Oct. 22, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (NASDAQ:SGMT), a clinical-stage biopharmaceutical company developing inhibitors of fatty acid synthase (FASN), a key lipid synthesis regulator, for acne, today announced that the first patient has been dosed in AURORA, its pivotal U.S. Phase 3 clinical trial of denifanstat in adults and adolescents aged 12 years and older with moderate to severe acne. AURORA is intended to support a potential U.S. New Drug Application (NDA) submission. The trial builds on positive Phase 3 clinical results and subsequent 52-week open-label extension data generated by Sagimet’s license partner Ascletis BioScience Co. Ltd. (Ascletis) in China. Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 in China where it holds an exclusive license to denifanstat, and by Sagimet in the rest of the world.