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Sagimet Biosciences Inc. (NASDAQ: SGMT) is a clinical-stage biopharmaceutical company advancing novel therapies targeting metabolic and fibrotic diseases through selective FASN inhibition. This page provides investors and industry stakeholders with timely updates on clinical trials, regulatory milestones, and strategic developments related to its lead candidate denifanstat and broader pipeline.
Access centralized, verified information on Sagimet’s progress in addressing metabolic dysfunction-associated steatohepatitis (MASH) and other conditions driven by abnormal lipid synthesis. Key updates include trial results, partnership announcements, and scientific advancements, all curated to support informed decision-making.
Explore press releases covering critical topics such as Phase 2b FASCINATE-2 trial outcomes, licensing agreements, and research innovations. Content is rigorously vetted to ensure accuracy and relevance for both professional analysts and engaged public audiences.
Bookmark this page for streamlined access to Sagimet’s latest developments in FASN inhibitor research. Check back regularly for authoritative updates on one of biopharma’s most promising approaches to metabolic disease treatment.
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.
Sagimet Biosciences presented Phase 2b data for denifanstat, its fatty acid synthase (FASN) inhibitor, at AASLD 2024. The FASCINATE-2 trial showed significant improvement in liver fibrosis in high-risk MASH patients, particularly in the F3 population where 49% of denifanstat-treated patients showed improvement versus 13% for placebo. AI-based digital pathology confirmed denifanstat's strong anti-fibrotic activity, especially in portal and peri-portal regions. Preclinical data also demonstrated FASN inhibitor's potential in reducing atherosclerosis, cholesterol, and inflammatory markers, suggesting broader cardiometabolic benefits.
Sagimet Biosciences (SGMT) reported Q3 2024 financial results and corporate updates. Key highlights include FDA's Breakthrough Therapy designation for denifanstat in MASH treatment, publication of Phase 2b FASCINATE-2 study results in The Lancet, and successful completion of end-of-Phase 2 FDA interactions. The company plans to initiate Phase 3 program by end of 2024. Financial position shows $170.0 million in cash and equivalents as of September 30, 2024, with runway through 2025. Q3 net loss was $14.6 million, with R&D expenses at $12.7 million and G&A expenses at $4.2 million.
Ascletis Pharma has completed enrollment of 480 patients in its Phase III clinical trial of ASC40 (denifanstat), a once-daily oral tablet for treating moderate to severe acne. The randomized, double-blind, placebo-controlled trial began on January 24, 2024, with patients divided equally between treatment and placebo groups. The study will evaluate 50 mg ASC40 over 12 weeks, with topline results expected in Q2 2025.
ASC40 is a first-in-class FASN inhibitor that works by inhibiting facial sebum production and reducing inflammation. The Phase II trial previously met primary and secondary endpoints with 19.4% of patients achieving treatment success versus 5.1% for placebo.
Sagimet Biosciences (Nasdaq: SGMT) has announced its participation in the UBS Global Healthcare Conference. The clinical-stage biopharmaceutical company, which focuses on developing therapeutics for metabolic and fibrotic pathways, will engage in a fireside chat on Wednesday, November 13, 2024, at 5 p.m. PST in Rancho Palos Verdes, California.
The event will be accessible via webcast through Sagimet's website in the Investors & Media section, with replay availability for 90 days after the live presentation.
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