Sagimet Biosciences Inc. (NASDAQ:SGMT) saw its stock soar 20% after unveiling encouraging Phase 3 trial results for its acne treatment candidate, denifanstat. The trial, conducted in China by its partner Ascletis Bioscience Co. Ltd., achieved all primary and secondary endpoints, boosting market confidence in the company’s innovative dermatology pipeline.
Denifanstat, a once-daily oral inhibitor of fatty acid synthase (FASN), demonstrated strong efficacy in patients with moderate to severe acne vulgaris. The 480-participant study showed meaningful reductions in both total and inflammatory lesion counts compared to placebo, with treatment success rates notably higher than those in the control group.
The findings highlight the clinical promise of targeting FASN as a novel approach to treating acne, a global condition affecting more than 640 million people. Sagimet CEO David Happel called the results a “significant milestone,” emphasizing that the company’s FASN-targeting platform could reshape how persistent skin conditions like acne are treated.
Dermatology expert Dr. Neal Bhatia noted that innovation in acne therapy has been relatively stagnant for decades. “Denifanstat offers a differentiated mechanism of action that addresses core pathways in acne pathogenesis,” he said, describing the treatment as a potential breakthrough for patients who’ve had limited options.
The therapy also appeared safe and well-tolerated. Most reported side effects – like dry skin and dry eyes – were mild and occurred at rates similar to those seen in the placebo group. No serious treatment-related adverse events were observed.
Following the positive outcome, Ascletis plans to submit a regulatory filing to China’s National Medical Products Administration. Meanwhile, Sagimet is moving ahead with a Phase 1 trial in the U.S. for TVB-3567, another FASN inhibitor aimed at treating acne in the American market.
Analyst Thomas Smith of Leerink Partners reiterated an Outperform rating and a $26 price target for the stock, citing the latest data as a validation of Sagimet’s FASN-inhibition strategy. “The trial results significantly strengthen the safety and efficacy profile of denifanstat and reinforce Sagimet’s potential in both acne and NASH markets,” he noted.
With strong data backing its lead candidate and further trials underway, Sagimet appears well-positioned to become a key player in dermatology and metabolic disease therapeutics.