Sagimet Biosciences Inc. Stock Price, News & Analysis

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.

Sagimet Biosciences (NASDAQ: SGMT) has received IND clearance for TVB-3567, its second fatty acid synthase (FASN) inhibitor, targeting acne treatment. The company plans to initiate a first-in-human Phase 1 clinical trial in 2025.

TVB-3567 is a potent and selective small molecule FASN inhibitor designed to treat acne by targeting sebum production. The planned Phase 1 trial will be a randomized double-blind placebo-controlled study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants with or without acne.

The development builds on promising data from their denifanstat program, which showed favorable sebum lipid composition changes in Phase 1 and significant decreases in acne lesions in a Phase 2 trial conducted by license partner Ascletis BioScience in China. With over 50 million people suffering from acne in the US, FASN inhibition represents a significant commercial opportunity, as it targets the production of approximately 80% of sebum lipids.

Sagimet Biosciences (Nasdaq: SGMT), a clinical-stage biopharmaceutical company, has announced an oral presentation on denifanstat’s effect on triglycerides and LDL-cholesterol in advanced fibrosis patients. This presentation will be delivered at the MASH Pathogenesis and Therapeutic Approaches Keystone Symposium, held from February 23-26, 2025, in Banff, Canada.

The presentation will feature lipidomic data from a post-hoc analysis of the Phase 2b FASCINATE-2 trial of denifanstat in MASH (Metabolic Associated Steatohepatitis). The title of the presentation is: Denifanstat, a Fatty Acid Synthase Inhibitor, Increased Circulating Polyunsaturated Triglycerides and Decreased LDL-Cholesterol in MASH Patients with Advanced Fibrosis in a Post-Hoc Analysis of FASCINATE-2 Study. It will be presented by Wen-Wei Tsai, Ph.D., Senior Director R&D, Translational Sciences, during the Symposia Spotlight: Emerging Mechanisms session on Wednesday, February 26, 2025, at 3:00 PM MST, at the Fairmont Banff Springs, Banff, AB, Canada.

Sagimet Biosciences (Nasdaq: SGMT) announced an upcoming oral presentation at the 9th Annual MASH-TAG Conference in Park City, Utah, from January 9-11, 2025. The presentation, scheduled for January 10 at 6:10 PM MST, will focus on fatty acid synthase (FASN) inhibitors and specifically highlight the differentiated mechanism of action of denifanstat and its anti-fibrotic effects observed in the Phase 2b FASCINATE-2 study in F2/F3 MASH patients.

Dr. Marie O'Farrell, SVP of Research and Development at Sagimet, will present during Session 4: The Promise of New Pharmacological Agents + Pathophysiology. Denifanstat, Sagimet's lead drug candidate, is an oral, once-daily FASN inhibitor that has received FDA Breakthrough Therapy designation for treating non-cirrhotic MASH with moderate to advanced liver fibrosis. Following successful Phase 2b results and FDA end-of-Phase 2 interactions, the drug is advancing to Phase 3 development.

Sagimet Biosciences (Nasdaq: SGMT) announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The clinical-stage biopharmaceutical company, which develops therapeutics for metabolic and fibrotic pathways, will present on Tuesday, December 3, 2024 at 10 a.m. EST in New York City. A webcast will be accessible through Sagimet's website, with replay available for 90 days after the event.