Sagimet Biosciences will present research on denifanstat and AI-based digital pathology at the MASH Drug Development Summit.
Quiver AI Summary
Sagimet Biosciences Inc. announced its participation in the 9th Annual MASH Drug Development Summit, where it will give two oral presentations and engage in a drug development panel from September 29 to October 1, 2025, in Boston, MA. The presentations will focus on the combination treatment of the FASN inhibitor denifanstat and AI-based digital pathology for evaluating anti-fibrotic effects in metabolic dysfunction-associated steatohepatitis (MASH) patients. Specific topics include the efficacy of denifanstat combined with GLP-1 treatments and its application in patients with advanced fibrosis, emphasizing its potential for long-term clinical benefits. Sagimet's lead candidate, denifanstat, has received Breakthrough Therapy designation from the FDA and is advancing toward further clinical development, alongside another candidate, TVB-3567, aimed at treating acne. MASH, affecting over 115 million people worldwide, has been newly named to reflect a more affirmative diagnosis for liver disease related to fat buildup.
Potential Positives
- Sagimet Biosciences will give two significant oral presentations at a key drug development summit, highlighting its role in advancing research on metabolic dysfunction-associated steatohepatitis (MASH) therapies.
- The company’s lead drug candidate, denifanstat, has received Breakthrough Therapy designation from the FDA, indicating its potential to effectively treat MASH with moderate to advanced liver fibrosis.
- Recent completion of the Phase 2b clinical trial (FASCINATE-2) for denifanstat showed positive results, reinforcing confidence in the therapeutic's efficacy.
- Sagimet has initiated a Phase 1 clinical trial for a second oral FASN inhibitor, TVB-3567, indicating its commitment to expanding its pipeline in innovative therapeutic areas.
Potential Negatives
- The press release contains a heavy emphasis on forward-looking statements, which highlights the uncertainty and risks associated with the company's future performance and clinical developments.
- Details regarding the success of the Phase 2b trial of denifanstat are presented, but there is no information on the subsequent steps or potential hurdles, raising concerns about the drug’s path forward.
- There is an implicit acknowledgment of significant risks in the company's clinical development and regulatory processes, which could affect investor confidence.
FAQ
What is Sagimet Biosciences presenting at the MASH Summit?
Sagimet will give two oral presentations on FASN inhibitors and AI-based digital pathology for MASH therapy development.
When is the MASH Drug Development Summit taking place?
The 9th Annual MASH Drug Development Summit will be held from September 29 to October 1, 2025.
Who are the presenters from Sagimet Biosciences?
Marie O’Farrell, Ph.D., and Wen-Wei Tsai, Ph.D., are the presenters representing Sagimet at the summit.
What is denifanstat's role in MASH treatment?
Denifanstat is a selective FASN inhibitor targeting metabolic dysfunction associated with steatohepatitis in MASH patients.
What is the significance of the name change for liver diseases?
The name changes aim to reduce stigma and provide a clearer diagnosis for liver diseases associated with fat buildup.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$SGMT Insider Trading Activity
$SGMT insiders have traded $SGMT stock on the open market 3 times in the past 6 months. Of those trades, 0 have been purchases and 3 have been sales.
Here’s a breakdown of recent trading of $SGMT stock by insiders over the last 6 months:
- DAVID HAPPEL (President & CEO) sold 65,478 shares for an estimated $598,115
- ELIZABETH ROZEK (General Counsel and CCO) sold 10,780 shares for an estimated $98,470
- EDUARDO BRUNO MARTINS (Chief Medical Officer) sold 8,277 shares for an estimated $75,607
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$SGMT Hedge Fund Activity
We have seen 34 institutional investors add shares of $SGMT stock to their portfolio, and 47 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- WOODLINE PARTNERS LP added 2,552,536 shares (+inf%) to their portfolio in Q2 2025, for an estimated $19,450,324
- NEA MANAGEMENT COMPANY, LLC removed 2,000,275 shares (-100.0%) from their portfolio in Q1 2025, for an estimated $6,520,896
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$SGMT Analyst Ratings
Wall Street analysts have issued reports on $SGMT in the last several months. We have seen 4 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- Wedbush issued a "Outperform" rating on 08/11/2025
- HC Wainwright & Co. issued a "Buy" rating on 08/07/2025
- Canaccord Genuity issued a "Buy" rating on 07/24/2025
- Jones Trading issued a "Buy" rating on 06/06/2025
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$SGMT Price Targets
Multiple analysts have issued price targets for $SGMT recently. We have seen 4 analysts offer price targets for $SGMT in the last 6 months, with a median target of $28.0.
Here are some recent targets:
- Yun Zhong from Wedbush set a target price of $28.0 on 08/11/2025
- Brandon Folkes from HC Wainwright & Co. set a target price of $29.0 on 08/07/2025
- Edward Nash from Canaccord Genuity set a target price of $28.0 on 07/24/2025
- Debanjana Chatterjee from Jones Trading set a target price of $27.0 on 06/06/2025
Full Release
SAN MATEO, Calif., Sept. 10, 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 will give two oral presentations and participate in a drug development panel at the 9 th Annual MASH Drug Development Summit taking place September 29-October 1, 2025 in Boston, MA. The two presentations will cover combination treatment with a FASN inhibitor, and AI-based digital pathology to evaluate denifanstat anti-fibrotic effect in MASH patients respectively.
Presentation Title: | Highlighting Mechanism of Action of FASN Inhibitor Denifanstat in MASH |
Presenter: | Marie O’Farrell, Ph.D., Senior Vice President of Research and Development, Sagimet Biosciences |
Session: | Revolutionizing MASH Therapy Development by Harnessing Biomarkers & Innovative Trial Designs to Accelerate Progress Towards Effective Combination & Sequential Therapies |
Date and time: | Monday, September 29, 2025, 2.45pm ET |
Key Highlights: | This presentation will focus on reviewing the preclinical activity of a FASN inhibitor combined with semaglutide or resmetirom and will highlight the efficacy of denifanstat when added to background GLP1 treatment in the Phase 2b FASCINATE-2 study. Dr. O’Farrell will also cover the planned Phase 1 PK study of denifanstat and resmetirom. |
Panel Discussion: | Designing Therapies with Novel Mechanisms & Predictive Biomarkers to Holistically Improve Treatment for Better Patient Outcomes |
Presenter: | Marie O’Farrell, Ph.D., Senior Vice President of Research and Development, Sagimet Biosciences |
Session: | Revolutionizing MASH Therapy Development by Harnessing Biomarkers & Innovative Trial Designs to Accelerate Progress Towards Effective Combination & Sequential Therapies |
Date and time: | Monday, September 29, 2025, 3.15pm ET |
Presentation Title: | Utilizing AI-Based Digital Pathology to Evaluate Denifanstat’s Anti-Fibrotic Effect in MASH Patients with Advanced Fibrosis |
Presenter: | Wen-Wei Tsai, Ph.D., Senior Director R&D, Translational Sciences, Sagimet Biosciences |
Session: | Revolutionizing MASH Diagnosis Using Non-Invasive Biomarkers to Enhance Precision for Earlier Detection to Improve Patient Outcomes |
Date and time: | Tuesday, September 30, 2025, 12.45pm ET |
Key Highlights: | This presentation will discuss the mechanism of action for denifanstat and its robust anti-fibrotic effect in MASH patients with F3 fibrosis as well as the application of digital pathology techniques to assess this anti-fibrotic effect. Dr. Tsai will also discuss the use of zonal analysis to explore denifanstat’s potential to offer long-term clinical benefit. |
About Sagimet Biosciences
Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction associated steatohepatitis (MASH). FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been successfully completed, supporting the advancement of denifanstat into further development. Sagimet has recently initiated a Phase 1 first-in-human clinical trial with a second oral FASN inhibitor drug candidate, TVB-3567, that is planned to be developed for acne in the U.S. For additional information about Sagimet, please visit www.sagimet.com .
About MASH
Metabolic-dysfunction associated steatohepatitis (MASH) is a progressive and severe liver disease which is estimated to impact more than 115 million people worldwide, for which there are few approved treatments. In 2023, global liver disease medical societies and patient groups formalized the decision to rename non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD) and nonalcoholic steatohepatitis (NASH) to MASH. Additionally, an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. The goal of the name change was to establish an affirmative, non-stigmatizing name and diagnosis.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding: the expected timing of the presentation of data from ongoing clinical trials, Sagimet’s clinical development plans and related anticipated development milestones, Sagimet’s cash and financial resources and expected cash runway. These statements involve known and unknown risks, uncertainties and other important factors that may cause Sagimet’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, these statements can be identified by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions.
The forward-looking statements in this press release are only predictions. Sagimet has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that Sagimet believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Sagimet’s control, including, among others: the clinical development and therapeutic potential of denifanstat, TVB-3567 or any other drug candidates Sagimet may develop; Sagimet’s ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines; Sagimet’s relationship with Ascletis, and the success of its development efforts for denifanstat; the accuracy of Sagimet’s estimates regarding its capital requirements; and Sagimet’s ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of Sagimet’s most recent filings with the Securities and Exchange Commission and available at www.sec.gov . You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in these forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, Sagimet operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Sagimet may face. Except as required by applicable law, Sagimet does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Contact:
Joyce Allaire
LifeSci Advisors
[email protected]