Item 8.01 Other Events. On August 13, 2026, Sagimet Biosciences Inc. (the “Company”) announced that the U.S. Food and Drug Administration cleared the Investigational New Drug application and issued a “Study May Proceed” letter for the Company’s Phase 3 clinical trial of fatty acid synthase inhibitor denifanstat in moderate to severe acne.
Filed Aug 13, 2026Accepted Aug 13, 2026, 7:05 AM EDTCIK 1400118Accession 0001193125-26-347854
Sagimet is a clinical-stage biopharmaceutical company developing novel FASN inhibitors designed to target dysfunctional metabolic and fibrotic pathways in conditions resulting from the overproduction of the fatty acid, palmitate. FASN is a regulator of lipid synthesis, a key pathway implicated in multiple diseases, such as acne, MASH and certain FASN-dependent tumor types. For additional information about Sagimet, please visit www.sagimet.com.
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Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
On August 13, 2026, Sagimet Biosciences Inc. (the “Company”) announced that the U.S. Food and Drug Administration cleared the Investigational New Drug application and issued a “Study May Proceed” letter for the Company’s Phase 3 clinical trial of fatty acid synthase inhibitor denifanstat in moderate to severe acne.