Ascletis Announces China National Medical Products Administration Acceptance of New Drug Application for Denifanstat (ASC40), a First-in-Class FASN Inhibitor for Acne Treatment
Sagimet Biosciences Inc. - Series A (SGMT)
Company Research
Source: PR Newswire
-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)."Acceptance of this NDA is an important milestone in our efforts to provide a potentially groundbreaking therapeutic approach for the treatment of moderate-to-severe acne," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "We are excited denifanstat (ASC40) is only one step away from the commercialization."Ascletis has comple
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News
- 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 [Yahoo! Finance]Yahoo! Finance
- 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 AdministrationGlobeNewswire
- Ascletis Announces China National Medical Products Administration Acceptance of New Drug Application for Denifanstat (ASC40), a First-in-Class FASN Inhibitor for Acne TreatmentPR Newswire
- Sagimet Biosciences Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) [Yahoo! Finance]Yahoo! Finance
- Sagimet Biosciences Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
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- 11/14/25 - Form SCHEDULE
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