Sagimet Biosciences Inc. Stock Price, News & Analysis

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.

Sagimet Biosciences (NASDAQ: SGMT) reported Q1 2025 financial results and provided corporate updates. The company plans to initiate a Phase 1 clinical trial in 2H 2025 to evaluate the combination of denifanstat and resmetirom, with data expected in 1H 2026. Pre-clinical data presented at EASL 2024 showed synergistic effects of combining FASN inhibitor with resmetirom, demonstrating 80% improvement in histological improvement compared to 33% and 25% for individual therapies. The company completed End-of-Phase 2 FDA interactions for denifanstat in MASH but requires additional funding before initiating Phase 3 trials. Financial highlights include cash position of $144.6 million, R&D expenses of $15.3 million, and a net loss of $18.2 million for Q1 2025.

Sagimet Biosciences (Nasdaq: SGMT) has announced three poster presentations featuring additional analyses from the Phase 2b FASCINATE-2 study of denifanstat in MASH at the upcoming EASL Congress 2025 in Amsterdam.

The presentations include: 1) An assessment of the MASH Resolution Index (MR-I) as a non-invasive biomarker for detecting MASH resolution, 2) Analysis of denifanstat's effect on bile acid levels and their correlation with histological improvements, and 3) Evaluation of denifanstat's antifibrotic effects using qFibrosis-based collagen features in high-risk patients.

All presentations will take place at the RAI Convention Centre, with two sessions scheduled for May 7 and one for May 10, 2025. Dr. Rohit Loomba from UC San Diego will present two posters, while Dr. Mary E. Rinella from University of Chicago will present the third.

Denifanstat, Sagimet's lead drug candidate, has received FDA Breakthrough Therapy designation for treating non-cirrhotic MASH with moderate to advanced liver fibrosis and is advancing to Phase 3 development.

Sagimet Biosciences (SGMT) reported its full year 2024 financial results and corporate updates. The company achieved significant milestones, including the initiation of its Phase 3 denifanstat program for MASH treatment, with patient screening expected in 1H 2025. The FDA granted Breakthrough Therapy designation for denifanstat following successful Phase 2b FASCINATE-2 results.

Key financial highlights:

• Cash position of $158.7 million as of December 31, 2024
• R&D expenses increased to $38.4 million in 2024 from $19.8 million in 2023
• Net loss widened to $45.6 million in 2024 from $27.9 million in 2023

The company received IND clearance for TVB-3567, a second FASN inhibitor for acne treatment. The Phase 3 program includes two trials: FASCINATE-3 for F2/F3 MASH patients and FASCINIT for MASLD/MASH patients, with a minimum of 1,800 patients expected to receive denifanstat.