Sagimet Biosciences Inc. (NASDAQ:SGMT) saw its shares climb 30% on Monday after the clinical-stage biopharmaceutical company said it intends to start a Phase 3 study of denifanstat for moderate to severe acne in the U.S. in the second half of 2026.
The company said it will move forward with denifanstat for the U.S. market based on recent successful Phase 3 outcomes in China. The planned U.S. study is contingent on Investigational New Drug - IND - clearance; Sagimet expects to file an IND application in mid-2026.
Denifanstat is designed to inhibit fatty acid synthase, a mechanism aimed at lowering sebum production and addressing local inflammation in moderate to severe acne vulgaris. Sagimet noted the condition affects roughly 10 million people in the U.S. each year. If approved, denifanstat would be administered as a once-daily oral medication and would represent the first innovative oral acne treatment in more than 40 years.
In January 2026, Sagimet’s licensing partner Ascletis Bioscience Co. Ltd. reported positive topline findings from an open-label Phase 3 trial in China. That trial evaluated the long-term safety of 50 mg of denifanstat taken once daily in 240 patients with moderate to severe acne. According to the company, the drug was generally well tolerated and participants showed improvements across all measured efficacy endpoints at 52 weeks.
Alongside development updates, Sagimet said it is prioritizing its dermatology franchise when allocating capital and will seek non-dilutive funding options for its MASH program. The company also provided an update on another FASN inhibitor in its pipeline: a first-in-human Phase 1 clinical trial of TVB-3567 is underway, with a Phase 2 study in moderate to severe acne patients planned for the second half of 2026.
Separately, Sagimet announced the pricing of an underwritten offering of 29,166,700 shares of its Series A common stock at $6.00 per share. The offering is expected to generate approximately $175.0 million in gross proceeds before expenses.
Summary
Sagimet plans a U.S. Phase 3 trial of denifanstat in H2 2026, subject to IND clearance planned for mid-2026, following positive Phase 3 topline results reported in China. The company emphasized dermatology as a capital priority, is pursuing non-dilutive funding for its MASH program, and disclosed an underwritten equity offering expected to raise about $175.0 million before expenses. A separate FASN inhibitor, TVB-3567, is in Phase 1 with Phase 2 planned for H2 2026.
Key points
- Sagimet shares rose 30% on the announcement of a planned U.S. Phase 3 trial for denifanstat in H2 2026, subject to IND clearance.
- Positive topline results from an open-label Phase 3 study in China showed denifanstat at 50 mg once daily was generally well tolerated and produced improvements on all efficacy endpoints at 52 weeks in 240 patients.
- Company priorities include directing capital to its dermatology franchise, seeking non-dilutive funding for the MASH program, and proceeding with clinical development of TVB-3567.
Risks and uncertainties
- Initiation of the planned U.S. Phase 3 trial is contingent on IND clearance - the outcome and timing of that regulatory step are not guaranteed and will affect the program timeline.
- The company is pursuing non-dilutive funding for the MASH program, but the availability and terms of such funding are uncertain and could influence capital resources and allocation decisions.
- Success in China does not ensure identical outcomes in the U.S. program; future trial results, tolerability, and efficacy in the U.S. population remain to be determined.