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SAN MATEO, Calif. - Sagimet Biosciences Inc. (NASDAQ:SGMT), a clinical-stage biopharmaceutical company with a market capitalization of $238 million and shares trading near $7.33, announced Friday that its fatty acid synthase (FASN) inhibitor denifanstat met all primary and secondary endpoints in a Phase 3 clinical trial for moderate to severe acne vulgaris conducted by its Chinese license partner Ascletis. The company’s stock has shown remarkable momentum, delivering a 136% return over the past six months, according to InvestingPro data.
The randomized, double-blind, placebo-controlled trial enrolled 480 patients in China who received either denifanstat 50mg or placebo once daily for 12 weeks. Treatment success rates with denifanstat were more than double those of placebo, with significant reductions in both inflammatory and non-inflammatory lesions.
Following these results, Ascletis completed pre-New Drug Application consultation with China’s National Medical Products Administration and plans to submit an NDA soon.
Data from the trial will be presented at the 2025 Fall Clinical Dermatology Conference taking place October 24-26 in Las Vegas, Nevada.
"Denifanstat’s Phase 3 results in acne demonstrate FASN inhibition’s potential as a novel mechanism of action for the treatment of acne," said David Happel, Chief Executive Officer of Sagimet, in the press release.
Denifanstat is being developed by Ascletis as ASC40 for acne in China and by Sagimet for metabolic dysfunction-associated steatohepatitis (MASH) in other markets. The drug has received Breakthrough Therapy designation from the FDA for treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis.
Sagimet recently initiated a Phase 1 trial of denifanstat in combination with resmetirom for MASH patients. The company has also begun a Phase 1 first-in-human trial with a second FASN inhibitor, TVB-3567, which it plans to develop for acne in the U.S.
According to the company, acne affects more than 50 million people annually in the U.S., with 5.1 million patients treated by dermatologists each year. With Sagimet’s next earnings report due on November 12, 2025, investors seeking deeper insights into the company’s financial health and growth prospects can access comprehensive analysis through InvestingPro, which offers exclusive ProTips and detailed financial metrics for over 1,400 US stocks.
In other recent news, Sagimet Biosciences Inc. announced that its fatty acid synthase inhibitor, denifanstat, successfully met all primary and secondary endpoints in a Phase 3 clinical trial for moderate to severe acne vulgaris in China. This trial, conducted by license partner Ascletis Bioscience, involved 480 patients and showed significant improvements in treatment success rate and lesion reduction. Additionally, Sagimet Biosciences has entered into a $75 million at-the-market sales agreement with Leerink Partners, allowing the sale of its Series A common stock. In a strategic move, the company has appointed KPMG LLP as its new independent auditor, replacing Deloitte & Touche LLP. Meanwhile, Clear Street has initiated a Buy rating on Sagimet Biosciences, with a price target of $29.00, highlighting the potential of denifanstat. Wedbush has also initiated coverage with an Outperform rating and a $28.00 price target, noting the company’s focus on treating conditions like metabolic dysfunction-associated steatohepatitis and acne. These developments reflect ongoing confidence in Sagimet Biosciences’ strategic and clinical direction.
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