On August 13, 2026, Sagimet Biosciences Inc. announced that the U.S. Food and Drug Administration cleared its Investigational New Drug application and issued a "Study May Proceed" letter for the Phase 3 clinical trial of denifanstat in moderate to severe acne. This regulatory milestone allows the company to initiate pivotal testing for its fatty acid synthase inhibitor candidate. Sagimet Biosciences Inc. operates in the biotechnology industry, focusing on the development of small molecule therapeutics.