Sagimet Biosciences (SGMT) Stock News

Sagimet Biosciences (Nasdaq: SGMT) announced positive Phase 3 trial results for denifanstat in treating moderate to severe acne, to be presented at the EADV Congress 2025. The trial, conducted by partner Ascletis in China, met all primary and secondary endpoints with 480 patients receiving either denifanstat 50mg or placebo daily for 12 weeks.

Key results include an 18.6% placebo-adjusted increase in treatment success rate, 22.0% reduction in total lesions, and 20.2% reduction in inflammatory lesions. Additionally, Sagimet has initiated a Phase 1 trial for TVB-3567, a second FASN inhibitor, for acne treatment.

Sagimet Biosciences (Nasdaq: SGMT) announced its participation in the 9th Annual MASH Drug Development Summit from September 29-October 1, 2025, in Boston. The company will deliver two oral presentations and participate in a panel discussion focused on their FASN inhibitor denifanstat.

Dr. Marie O'Farrell will present findings on denifanstat's mechanism of action in MASH, including combination treatments with semaglutide and resmetirom, highlighting results from the Phase 2b FASCINATE-2 study. Dr. Wen-Wei Tsai will discuss the application of AI-based digital pathology in evaluating denifanstat's anti-fibrotic effects in MASH patients with F3 fibrosis.

Sagimet Biosciences (Nasdaq: SGMT), a clinical-stage biopharmaceutical company focused on developing therapeutics for metabolic and fibrotic pathways, has announced its participation in two upcoming investor conferences in September 2025.

The company will present at the Cantor Global Healthcare Conference on September 3, featuring a fireside chat at 1:35 p.m. ET, and the H.C. Wainwright 27th Annual Global Investment Conference on September 9. A webcast of the Cantor presentation will be available on Sagimet's website for 90 days after the event.

Sagimet Biosciences (NASDAQ:SGMT) reported significant progress in Q2 2025, highlighted by positive Phase 3 trial results for denifanstat in acne treatment through its partner Ascletis in China. The trial met all primary endpoints, showing 33.2% treatment success vs. 14.6% for placebo.

The company initiated a Phase 1 trial for TVB-3567, another FASN inhibitor for acne treatment in the U.S. Additionally, Sagimet plans to start a Phase 1 trial evaluating denifanstat combined with resmetirom for MASH treatment in 2H 2025. As of June 30, 2025, the company reported $135.5 million in cash and equivalents, with a net loss of $10.4 million for Q2 2025.

Sagimet Biosciences (Nasdaq: SGMT), a clinical-stage biopharmaceutical company focused on developing novel therapeutics for metabolic and fibrotic pathways, will participate in the Canaccord Genuity 45th Annual Growth Conference.

The company's management will engage in a fireside chat on August 13, 2025, at 2 p.m. EDT in Boston, MA. Investors can access the webcast through Sagimet's website, with a replay available for 90 days after the event.

Sagimet Biosciences (NASDAQ: SGMT) announced a virtual KOL event scheduled for June 16, 2025, featuring Dr. Neal Bhatia to discuss positive Phase 3 trial results of denifanstat for moderate to severe acne treatment. The study, conducted by license partner Ascletis in China, met all primary and secondary endpoints versus placebo with good tolerability. Denifanstat, a once-daily oral FASN inhibitor, represents a novel treatment approach for acne, which affects over 50 million Americans annually. The company will also discuss their Phase 1 trial of TVB-3567, their second oral FASN inhibitor candidate for acne treatment in the U.S. The event will include a Q&A session, with a replay available on Sagimet's website for 90 days.

Sagimet Biosciences (NASDAQ: SGMT) announced positive Phase 3 trial results for denifanstat (ASC40) in treating moderate-to-severe acne, conducted by partner Ascletis in China. The trial met all primary and secondary endpoints, with denifanstat showing significant improvements over placebo. The drug achieved 33.2% treatment success rate versus 14.6% for placebo, and demonstrated substantial reductions in total lesion count (-57.4% vs -35.4%), inflammatory lesions (-63.5% vs -43.2%), and non-inflammatory lesions (-51.9% vs -28.9%). The oral FASN inhibitor was well-tolerated with mild to moderate side effects, primarily dry skin (6.3%) and dry eye (5.9%). Ascletis plans to submit for approval in China. Additionally, Sagimet has initiated a Phase 1 trial for TVB-3567, a second FASN inhibitor, for acne treatment in the US market.

Ascletis announces successful Phase III trial results for Denifanstat (ASC40), a first-in-class oral FASN inhibitor for acne treatment. The trial met all endpoints with 33.2% treatment success vs 14.6% for placebo. Denifanstat showed superior efficacy compared to FDA-approved treatments: 98% more effective than sarecycline, 178% more effective than doxycycline, and 60% more effective than clascoterone cream in placebo-adjusted treatment success. The drug demonstrated significant reductions in total lesion count (57.4%), inflammatory lesions (63.5%), and non-inflammatory lesions (51.9%). With a favorable safety profile and only mild to moderate adverse events, Denifanstat's unique mechanism directly targets sebum overproduction, a root cause of acne. The once-daily oral treatment offers potential advantages over topical treatments, which suffer from 30-40% non-adherence rates.

Sagimet Biosciences (NASDAQ: SGMT) announced a virtual KOL event scheduled for May 29, 2025, focusing on the potential combination therapy of denifanstat and resmetirom for treating advanced Metabolic Dysfunction-Associated Steatohepatitis (MASH). The event will feature Dr. Rohit Loomba from UC San Diego and company management discussing the planned Phase 1 pharmacokinetic trial of this combination.

The development strategy builds on successful Phase 2b FASCINATE-2 trial results of denifanstat in MASH F2-F3 patients and preclinical data showing synergistic effects when combining FASN inhibitors with resmetirom. Preclinical studies presented at EASL 2024 demonstrated that the combination improved liver disease markers more effectively than single agents, including better NAS scores and hepatic collagen content improvements.

Denifanstat, Sagimet's lead candidate, is an oral, daily FASN inhibitor that may complement resmetirom's fat oxidizer properties in treating MASH patients.