Sagimet's License Partner Ascletis Announced Acceptance of New Drug Application for Denifanstat for the Treatment of Moderate to Severe Acne by China's National Medical Products Administration

SAN MATEO, Calif., Dec. 10, 2025 (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 December 10 statement that China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for denifanstat for the treatment of moderate to severe acne. Sagimet has granted an exclusive license to denifanstat for China to Ascletis Bioscience Co. Ltd. (Ascletis), of which Ascletis Pharma Inc. is the parent company.

GlobeNewsWire • Dec 10, 2025

Ascletis Announces China National Medical Products Administration Acceptance of New Drug Application for Denifanstat (ASC40), a First-in-Class FASN Inhibitor for Acne Treatment

-Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo in a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial. HONG KONG , Dec. 10, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor for the treatment of moderate-to-severe acne vulgaris, has been accepted by the China National Medical Products Administration (NMPA).

PRNewsWire • Dec 10, 2025

Sagimet Biosciences Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

SAN MATEO, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that, in connection with the hiring of three employees, the Compensation Committee of Sagimet's Board of Directors approved inducement grants of 42,800 stock options in aggregate to purchase shares of the Company's Series A common stock as determined based on the Black Scholes value on December 9, 2025, to be granted on December 9, 2025 to the three newly-hired employees.

GlobeNewsWire • Dec 9, 2025

Sagimet Biosciences to Participate in the 8th Annual Evercore ISI Healthcare Conference

SAN MATEO, Calif., Nov. 20, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that management will participate in the 8th Annual Evercore ISI Healthcare Conference on Tuesday, December 2, 2025, in Coral Gables, Florida, with a fireside chat at 12:55pm ET (link here).

GlobeNewsWire • Nov 20, 2025

Sagimet Biosciences Advances Denifanstat: Q3 Earnings And Upcoming Catalysts

Sagimet Biosciences reported a Q3 GAAP EPS loss of -$0.40, missing estimates, but maintains strong momentum with Denifanstat's clinical progress. SGMT's cash position remains robust at $125.5 million, supporting clinical milestones into 2026 despite ongoing R&D-driven losses and disciplined operating spend. Denifanstat advances in Phase 1 combination studies for MASH and acne, with key data readouts expected in 2026 to drive further stock upside.

Seeking Alpha • Nov 18, 2025

Sagimet Biosciences Presents Two Denifanstat Posters at AASLD—The Liver Meeting® 2025

A secondary analysis of FASCINATE-2 Phase 2 trial demonstrated denifanstat improved fibrosis, inflammation and steatosis in advanced qF4 MASH patients as measured by artificial intelligence (AI) digital pathology In a second poster, spatial computational histology relying on baseline fibrosis features was used to predict response to denifanstat SAN MATEO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced the presentation of two posters at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting® 2025, taking place November 7-11, 2025 in Washington, DC: A Poster of Distinction titled “Denifanstat elicited a significant ≥2-stage improvement in fibrosis in F3 MASH patients, and improved liver fibrosis and biomarkers in qFibrosis stage 4 MASH patients: secondary analysis of phase 2b FASCINATE-2 trial” was presented by Rohit Loomba, M.D.

GlobeNewsWire • Nov 10, 2025

Denifanstat Achieved All Endpoints in the Treatment of Moderate to Severe Acne in Phase 3 Clinical Trial in Acne in China: A Presentation at the 2025 Fall Clinical Dermatology Conference

Denifanstat met all primary and secondary endpoints versus placebo and was generally well tolerated in a Phase 3 clinical trial in acne in China conducted by license partner Ascletis Ascletis announced completion of its pre-NDA consultation with China's NMPA and its plans to submit an NDA for denifanstat in China SAN MATEO, Calif., Oct. 24, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported that data from a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris conducted by Sagimet's license partner for China, Ascletis Bioscience Co. Ltd.

GlobeNewsWire • Oct 24, 2025

All You Need to Know About Sagimet Biosciences Inc. (SGMT) Rating Upgrade to Strong Buy

Sagimet Biosciences Inc. (SGMT) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #1 (Strong Buy).

Zacks Investment Research • Oct 15, 2025

Ascletis Completes Denifanstat (ASC40) Pre-NDA Consultation with China National Medical Products Administration

- Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo in a Phase III randomized, double-blind, placebo-controlled, multicenter clinical trial. HONG KONG , Oct. 14, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that it recently completed the pre-New Drug Application (NDA) consultation with China National Medical Products Administration (NMPA) for denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris and plans to submit an NDA soon.

PRNewsWire • Oct 14, 2025

Sagimet Biosciences Announces Participation in Three Upcoming Investor Conferences

SAN MATEO, Calif., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that management will participate in three upcoming investor conferences.

GlobeNewsWire • Oct 14, 2025