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Sagimet Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Updates

Completed Phase 1 pharmacokinetic (PK) clinical trial of denifanstat and resmetirom combination Phase 2 trial of denifanstat/resmetirom combination in F4 MASH patients planned to initiate in 2H 2026 Secured global, exclusive license to TAPI's innovative forms of resmetirom active pharmaceutical ingredients (API) First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing Positive topline results in open-label Phase 3 trial evaluating the long-term safety of denifanstat in patients with moderate to severe acne in China reported by Ascletis China's National Medical Products Administration (NMPA) accepted Ascletis' New Drug Application (NDA) for denifanstat for the treatment of moderate to severe acne SAN MATEO, Calif., March 11, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided recent corporate updates.

Sagimet Announces Positive 52-Week Data from License Partner Ascletis' Open-Label Phase 3 Clinical Trial Evaluating the Long-Term Safety of ASC40 (Denifanstat) Tablets in Patients with Moderate to Severe Acne

SAN MATEO, Calif., Feb. 02, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that Ascletis Pharma Inc. issued a press release on January 29th reporting positive topline results in the open-label Phase 3 trial evaluating the long-term safety of ASC40 (denifanstat) tablets in patients with moderate to severe acne.

Ascletis Announces Positive Topline Results from Its Phase III Open-Label Study of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne

-  Denifanstat (ASC40), a once-daily oral fatty acid synthase (FASN) inhibitor, demonstrated favorable safety and tolerability in a Phase III open-label study -  The exceptional efficacy of denifanstat (ASC40) observed in the Company's previously reported placebo-controlled Phase III trial coupled with a favorable safety profile in two Phase III trials provide a potential major break-through for the treatment of acne -  New Drug Application for denifanstat (ASC40) for acne was recently accepted by the China National Medical Products Administration HONG KONG, Jan. 29, 2026 /PRNewswire/ --  Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announced positive topline results from the Phase III open-label study (NCT06248008) evaluating denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor, in patients with moderate-to-severe acne vulgaris. This recently completed second Phase III study was an open-label, multicenter study in China designed to evaluate the long-term safety of denifanstat (ASC40) in 240 patients with moderate to severe acne vulgaris.

Biotech Veteran and Virologist Joins CancerVax as Senior Scientific Advisor

Dr. George Kemble, former AstraZeneca executive, to advise the Company on immunological and viral strategies for its novel cancer treatment platform Dr. George Kemble, former AstraZeneca executive, to advise the Company on immunological and viral strategies for its novel cancer treatment platform