Denifanstat met all primary and secondary endpoints versus placebo and was generally well tolerated in a Phase 3 clinical trial in acne in China conducted by license partner Ascletis Ascletis announced completion of its pre-NDA consultation with China’s NMPA and its plans to submit an NDA for denifanstat in China SAN MATEO, Calif., Oct. 24, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metab ...

Summary of Sagimet Biosciences Conference Call Company Overview - **Sagimet Biosciences** is a clinical-stage biopharmaceutical company focused on developing novel fatty acid synthase (FASN) inhibitors targeting metabolic and inflammatory diseases, particularly MASH (metabolic dysfunction-associated steatotic liver disease) and acne [2][3] Core Scientific Focus - The primary drug in development is **Denifanstat**, which inhibits overactive FASN, a key enzyme in lipid synthesis implicated in various diseases [2][3] - Denifanstat targets fat accumulation, inflammation, and fibrosis, addressing root causes common to MASH and other conditions [6][8] Clinical Development and Results - **FASCINATE-2 Study**: A phase 2b clinical trial showed Denifanstat met primary and secondary endpoints, demonstrating statistically significant improvements in fibrosis in severe MASH patients [3][12] - In F3 patients, there was a 36% improvement in fibrosis over placebo for one-stage improvement and a 30% improvement for two-stage [12] - **Combination Therapy**: A phase 1 PK study combining Denifanstat with Resmetirom has been initiated, expecting top-line results in the first half of next year [4] - **Acne Program**: A phase 3 trial in China for moderate to severe acne met all primary and secondary endpoints, with plans for submission to NMPA [4][28] Mechanism of Action - Denifanstat uniquely inhibits FASN, directly affecting stellate cells and reducing fibrosis, unlike other metabolic drugs that act indirectly [6][8][13] - The drug is a once-daily oral treatment, providing a differentiated approach in managing MASH and acne [6][8] Digital Pathology and AI Integration - The use of **AI-based digital pathology** enhances the quantification of fibrosis and fat deposition, providing more precise assessments than traditional methods [16][17] - Digital pathology is expected to play a significant role in regulatory frameworks for MASH endpoints, with FDA showing interest in non-invasive measures [19][20] Market Opportunity - The acne market is seen as underdeveloped, with Denifanstat offering a new mechanism of action that could significantly impact treatment options for moderate to severe acne patients [30][31] - Approximately 50 million Americans suffer from acne, with 20% classified as moderate to severe, presenting a substantial market opportunity [31] Conclusion - Sagimet Biosciences is positioned to make significant advancements in treating metabolic and inflammatory diseases through its innovative FASN inhibitors, with promising clinical data and a strong market potential in both MASH and acne [2][3][28]

Sagimet Biosciences Inc. (SGMT) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #1 (Strong Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following ...

SAN MATEO, Calif., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that management will participate in three upcoming investor conferences. H.C. Wainwright Liver Disease Virtual Conference on October 21-22, 2025, with a fireside chat available starting October 21 at 7am ET (link here).Guggenheim 2nd Annual Healthcare Innovation ...

Since my previous coverage on Sagimet Biosciences Inc (NASDAQ: SGMT ), the stock has traded a bit sideways, down just 2% over the past month. However, last month we got some very nice updates from management onI hold a Master’s degree in Cell Biology and began my career working for several years as a lab technician in a drug discovery clinic, where I gained extensive hands-on experience in cell culture, assay development, and therapeutic research. That scientific foundation gave me an appreciation for the r ...

SAN MATEO, Calif., Oct. 07, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that analyses of the Phase 2b FASCINATE-2 study showing that denifanstat elicited fibrosis improvement in patients with advanced fibrosis will be presented at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting® 2025, taking place November ...

Dosing has successfully commenced with healthy volunteersPrimary endpoints for the Phase 1 trial include safety, tolerability, and pharmacokinetic (PK) profile of the combinationTopline data are anticipated in the first half of 2026 SAN MATEO, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that the Company has dosed the ...

Company Overview - Sagimet Biosciences Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways [3] - The company is developing fatty acid synthase (FASN) inhibitors, with its lead drug candidate, denifanstat, being an oral, once-daily pill for treating metabolic dysfunction associated steatohepatitis (MASH) [3] - Denifanstat has received Breakthrough Therapy designation from the FDA for treating non-cirrhotic MASH with moderate to advanced liver fibrosis [3] Clinical Trials and Developments - The FASCINATE-2 Phase 2b clinical trial of denifanstat in MASH has been successfully completed with positive results [3] - Sagimet has initiated a Phase 1 first-in-human clinical trial for a second oral FASN inhibitor, TVB-3567, which is planned for acne treatment in the U.S. [3] Upcoming Events - Sagimet will participate in a drug development panel at Fierce Biotech Week from October 7-9, 2025, in Boston, MA [1] - The panel titled "How Biotechs are Leveraging Artificial Intelligence (AI)/Machine Learning (ML) to Drive Efficiency and ROI" will feature Dr. Marie O'Farrell, Senior Vice President of Research and Development at Sagimet [2] - The discussion will focus on the application of AI in drug development, particularly how Sagimet employs AI-based digital pathology platforms to enhance clinical trials for MASH [2]

Core Insights - Sagimet Biosciences has reported that its lead drug candidate, denifanstat, has successfully met all primary and secondary endpoints in a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris [2][3][4] Group 1: Clinical Trial Results - The Phase 3 clinical trial was a randomized, double-blind, placebo-controlled study involving 480 patients in China, assessing denifanstat at a dosage of 50 mg once daily for 12 weeks [3] - Denifanstat achieved an 18.6% placebo-adjusted increase in treatment success rate, a 22.0% placebo-adjusted reduction in total lesions, and a 20.2% placebo-adjusted reduction in inflammatory lesions [4] - The drug was generally well tolerated among participants [3][4] Group 2: Company Developments - Sagimet has initiated a Phase 1 first-in-human clinical trial for a second FASN inhibitor, TVB-3567, aimed at treating acne in the U.S. [5][7] - Denifanstat is also being developed for metabolic dysfunction associated steatohepatitis (MASH) and has received Breakthrough Therapy designation from the FDA for this indication [6] Group 3: Market Context - Acne affects over 50 million people annually in the U.S., with a significant market opportunity due to the chronic nature of the condition and the need for ongoing management [5][8] - The U.S. acne market includes approximately 5.1 million patients treated by dermatologists each year, highlighting the demand for innovative treatment options [8]

Core Viewpoint - Sagimet Biosciences Inc. (SGMT) has experienced significant selling pressure, resulting in a 15.8% decline over the past four weeks, but analysts anticipate improved earnings in the near future [1] Group 1: Technical Analysis - The Relative Strength Index (RSI) for SGMT is currently at 27.37, indicating that the stock is oversold and may be poised for a rebound as selling pressure exhausts [5] - RSI is a momentum oscillator that helps identify overbought or oversold conditions, with readings below 30 typically indicating an oversold status [2][3] Group 2: Fundamental Indicators - There has been a strong consensus among sell-side analysts to raise earnings estimates for SGMT, leading to an 8% increase in the consensus EPS estimate over the last 30 days, which often correlates with price appreciation [7] - SGMT holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, suggesting a potential turnaround [8]