Sagimet Biosciences Inc. (NASDAQ:SGMT) surged 30% on Monday after unveiling plans to launch a Phase 3 clinical trial of denifanstat for moderate to severe acne in the U.S. during the second half of 2026.
The clinical-stage biopharmaceutical company said it is advancing denifanstat into the U.S. acne market, supported by recently reported positive Phase 3 data from China. The upcoming trial will depend on Investigational New Drug clearance, with the company aiming to submit its IND application by mid-2026.
Denifanstat Targets Key Drivers of Acne
Sagimet explained that denifanstat works by inhibiting fatty acid synthase, helping to lower sebum production while also addressing localized inflammation associated with acne vulgaris. The condition impacts roughly 10 million people annually in the U.S.
If approved, the company said denifanstat would be a once-daily oral therapy and the first new oral acne treatment in more than four decades.
Positive China Trial Data Supports U.S. Strategy
In January 2026, Sagimet’s partner Ascletis Bioscience Co. Ltd. reported encouraging topline results from an open-label Phase 3 study conducted in China. The trial evaluated long-term safety of a 50 mg once-daily dose of denifanstat in 240 patients with moderate to severe acne.
The treatment was generally well tolerated, with participants demonstrating improvements across all measured efficacy endpoints over a 52-week period.
Pipeline Priorities and Capital Strategy
Sagimet also indicated it is placing greater emphasis on its dermatology portfolio when allocating capital, while seeking non-dilutive funding avenues for its MASH program. Meanwhile, its first-in-human Phase 1 trial of FASN inhibitor TVB-3567 remains underway, and a Phase 2 study in moderate to severe acne is planned for the latter half of 2026.
Separately, the company disclosed the pricing of an underwritten offering of 29,166,700 shares of Series A common stock at $6.00 per share. The transaction is expected to generate gross proceeds of approximately $175.0 million before expenses.
More about Sagimet Biosciences Inc.
Sagimet Biosciences Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting fatty acid synthase (FASN) to treat metabolic and dermatological diseases.