Sagimet Biosciences(SGMT)
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Wall Street Analysts Predict a 437.05% Upside in Sagimet Biosciences Inc. (SGMT): Here's What You Should Know
ZACKS· 2025-06-09 15:01
Core Viewpoint - Sagimet Biosciences Inc. (SGMT) shares have increased by 70.6% in the past four weeks, closing at $5.56, with a mean price target of $29.86 indicating a potential upside of 437.1% according to Wall Street analysts [1] Group 1: Price Targets and Analyst Estimates - The mean estimate consists of seven short-term price targets with a standard deviation of $20.44, indicating variability among analysts; the lowest estimate suggests a 10.1% decline, while the highest predicts a surge of 1105% to $67 [2] - Analysts' consensus on price targets is often questioned, as they may not accurately reflect the stock's future price movements [3][7] - A low standard deviation in price targets suggests a high degree of agreement among analysts regarding the stock's price direction, which can serve as a starting point for further research [9] Group 2: Earnings Estimates and Market Sentiment - Analysts are optimistic about SGMT's earnings prospects, as indicated by a strong agreement in revising EPS estimates higher, which correlates with potential stock price increases [11] - The Zacks Consensus Estimate for the current year has risen by 26.4% over the past month, with four estimates increasing and no negative revisions [12] - SGMT holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, suggesting a strong potential upside [13]
Sagimet Biosciences to Host Virtual KOL Event, “A New Mechanism of Action in Treating Acne: Update on Positive Phase 3 Denifanstat Trial for the Treatment of Moderate to Severe Acne” on June 16, 2025
Globenewswire· 2025-06-09 11:00
Core Insights - Sagimet Biosciences Inc. is hosting a virtual key opinion leader event on June 16, 2025, to discuss the efficacy and tolerability results of denifanstat for treating moderate to severe acne vulgaris in China [1][2] - Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor that met all primary and secondary endpoints in a Phase 3 clinical trial, demonstrating its potential as a novel treatment for acne, which affects over 50 million people in the U.S. annually [3][7] - The company has initiated a Phase 1 first-in-human study for its second oral FASN inhibitor, TVB-3567, aimed at treating acne in the U.S. [3][6] Company Overview - Sagimet is a clinical-stage biopharmaceutical company focused on developing FASN inhibitors to target metabolic and fibrotic diseases caused by excessive palmitate production [6] - The lead drug candidate, denifanstat, has received Breakthrough Therapy designation from the FDA for treating non-cirrhotic metabolic dysfunction associated steatohepatitis (MASH) with moderate to advanced liver fibrosis [6] - The company successfully completed a Phase 2b clinical trial of denifanstat in MASH, achieving positive results [6] Industry Context - The U.S. acne market includes over 50 million individuals, with 5.1 million patients treated by dermatologists annually [7] - Acne management often requires chronic treatment, as there is currently no cure, and adherence to topical therapies is lower compared to oral medications, with 30% to 40% of patients not adhering to topical treatments [7]
Sagimet Biosciences:萨吉梅特生物科学公司(SGMT):与Ascletis合作的3期试验证实denifanstat在痤疮治疗中的疗效-20250605
Goldman Sachs· 2025-06-05 05:45
Investment Rating - The report designates Sagimet Biosciences (SGMT) as an Early-Stage Biotech with a focus on denifanstat for acne treatment [10]. Core Insights - Positive topline results from a Phase 3 trial of denifanstat in moderate to severe acne were announced, showing statistically significant improvements over placebo on all primary endpoints [1][2]. - The trial involved 480 patients and demonstrated a treatment success rate of 33.2% for denifanstat compared to 14.6% for placebo, with significant reductions in total and inflammatory lesion counts [7][8]. - The favorable safety profile of denifanstat was noted, with comparable rates of treatment-related adverse events (TRAEs) between denifanstat and placebo [5][6]. Summary by Sections Trial Results - The Phase 3 trial was randomized, double-blind, and placebo-controlled, evaluating denifanstat's efficacy and safety over a 12-week period [2]. - Key primary endpoints included the percentage of patients achieving treatment success, percentage reduction in total lesion count, and percentage reduction in inflammatory lesion count [3][5]. - Denifanstat achieved a 57.4% reduction in total lesion count and a 63.5% reduction in inflammatory lesion count compared to 35.4% and 43.2% for placebo, respectively [7]. Regulatory and Financial Implications - Ascletis plans to submit for regulatory approval in China imminently, which could lead to milestone payments of up to $122 million for SGMT [1][8]. - SGMT retains rights to denifanstat outside of China, allowing for potential development in the U.S. market, although regulatory pathways remain uncertain [8][9]. Future Development - The data from the trial supports SGMT's internal efforts with its next-generation FASN inhibitor, TVB-3567, which is currently in a Phase 1 trial for moderate to severe acne [9]. - The U.S. acne market is estimated to have a patient population of approximately 50 million, with SGMT expressing enthusiasm for the potential of TVB-3567 [9].
Sagimet: Positive China Partner Acne Vulgaris Data Bodes Well For TVB-3567
Seeking Alpha· 2025-06-04 17:45
Group 1 - The article is authored by Terry Chrisomalis, who operates the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace, offering a two-week free trial for new subscribers [1] - Biotech Analysis Central includes a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and various analysis and news reports to assist healthcare investors [2] - The service is priced at $49 per month, with a yearly plan available at a discounted rate of $399, reflecting a 33.50% discount [1] Group 2 - The article does not provide any specific investment recommendations or advice regarding the suitability of investments for particular investors [4] - The author has no current stock or derivative positions in any mentioned companies and does not plan to initiate any within the next 72 hours [3] - The views expressed in the article may not represent those of Seeking Alpha as a whole, as the platform includes contributions from various authors, both professional and individual investors [4]
Sagimet Biosciences Announces Positive Phase 3 Results for Denifanstat for the Treatment of Moderate-to-Severe Acne from Partner Ascletis
GlobeNewswire News Room· 2025-06-04 09:00
Core Insights - Sagimet Biosciences Inc. reported that denifanstat met all primary and secondary endpoints in a Phase 3 clinical trial for moderate to severe acne vulgaris conducted by Ascletis in China [3][9] - Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor, with plans for further development in the U.S. for acne treatment [3][9] - The Phase 3 trial demonstrated significant efficacy, with denifanstat showing a treatment success rate of 33.2% compared to 14.6% for placebo [8] Company Overview - Sagimet is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways [10] - The lead drug candidate, denifanstat, is also being developed for metabolic dysfunction associated with steatohepatitis (MASH) and has received Breakthrough Therapy designation from the FDA [10] - 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. [3][10] Clinical Trial Details - The Phase 3 trial was a randomized, double-blind, placebo-controlled study involving 480 patients, with a treatment duration of 12 weeks [5][7] - Primary endpoints included treatment success defined by Investigator's Global Assessment (IGA) score, total lesion count, and inflammatory lesion count [7][8] - Denifanstat demonstrated a 57.4% reduction in total lesion count compared to a 35.4% reduction in the placebo group [8] Efficacy Results - Denifanstat achieved a significant percentage change in inflammatory lesion count of -63.5% versus -43.2% for placebo, with a p-value of <0.0001 [8] - The absolute change in total lesion count was -58.3 for denifanstat compared to -36.2 for placebo, indicating a strong therapeutic effect [8] - The treatment was generally well-tolerated, with no serious adverse events reported [8][9] Market Context - Acne affects over 640 million people globally, with more than 50 million in the U.S. alone, highlighting a significant market opportunity for effective treatments [4][11] - Current acne treatments often have limited efficacy or potential side effects, making the development of new therapeutic approaches critical [4][11]
Sagimet Biosciences (SGMT) Update / Briefing Transcript
2025-05-29 18:00
Summary of Sagimet Biosciences Post EASL Key Opinion Leader Call Company Overview - **Company**: Sagimet Biosciences - **Lead Asset**: Denifenstat, a once-daily oral small molecule targeting fatty acid synthase (FASN) inhibition, primarily focused on treating non-alcoholic steatohepatitis (NASH) and other conditions like acne and certain solid tumors [7][11] Industry Context - **NASH Market**: The NASH market is projected to double in size over the next two decades, with an expected prevalence of at least 3.5 million patients in the U.S. alone [11] - **Combination Therapy**: The company is exploring a combination therapy of Denifenstat and Resmidoram, which is anticipated to improve outcomes for severe NASH patients [8][11] Key Clinical Data - **Phase 2b FASTINate-two Trial**: - Focused on severe NASH patients, showing significant improvements in liver histology and fibrosis. - Primary endpoint: 38% response rate in the Denifenstat group versus 16% in placebo for a two-point improvement in NAFLD activity score without worsening fibrosis [24] - Secondary endpoint: 41% one-stage improvement in fibrosis without worsening NASH in the Denifenstat group versus 18% in placebo [26] - Adverse events were generally well tolerated, with no significant liver injury signals [22] Development Plans - **Future Studies**: - A Phase 1 pharmacokinetic (PK) study of the Denifenstat and Resmidoram combination is planned for the second half of 2025, with top-line data expected in early 2026 [8][46] - A Phase 2 trial targeting F4 NASH patients is anticipated to follow, focusing on liver biopsy as a primary endpoint [47] Mechanism of Action - **Denifenstat**: Inhibits de novo lipogenesis, reducing hepatic steatosis and inflammation, and potentially lowering the risk of hepatocellular carcinoma [15][41] - **Combination Rationale**: The combination of Denifenstat and Resmidoram is hypothesized to have a synergistic effect, enhancing both DNL inhibition and mitochondrial beta-oxidation [40][42] Regulatory Considerations - **Combination Approval Pathway**: The regulatory pathway for the fixed-dose combination is independent of the monotherapy approval, allowing for simultaneous development [88] Market Potential - **Patient Population**: The focus is on advanced NASH patients, particularly those with stage 3 and 4 fibrosis, who are currently underserved by existing treatments [11][41] - **Patent Strategy**: A patent application for the Denifenstat and Resmidoram combination has been filed, potentially extending market exclusivity until 2048 [50] Additional Insights - **Adverse Events**: Hair thinning was noted as a treatment-related adverse event, with a 7% discontinuation rate due to this issue [22] - **Biomarker Development**: Non-invasive biomarkers such as MRI PDFF and ALT/AST slopes will be utilized to assess treatment response in future trials [59] Conclusion Sagimet Biosciences is positioned to make significant advancements in the treatment of NASH through its innovative Denifenstat and Resmidoram combination therapy, with promising clinical data and a clear regulatory strategy. The company aims to address a large and growing patient population with unmet medical needs in the NASH market.
Sagimet Biosciences to Host Virtual KOL Event, “Evaluating the Synergistic Potential of a Combination of Denifanstat and Resmetirom for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)” on May 29, 2025
Globenewswire· 2025-05-22 12:00
Core Viewpoint - Sagimet Biosciences Inc. is advancing its clinical-stage biopharmaceutical development, focusing on novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) through a combination therapy approach involving denifanstat and resmetirom [1][2][3] Company Overview - Sagimet Biosciences is a clinical-stage biopharmaceutical company developing fatty acid synthase (FASN) inhibitors targeting metabolic and fibrotic pathways [6][7] - The lead product candidate, denifanstat, is an oral, once-daily selective FASN inhibitor aimed at treating MASH, which has received Breakthrough Therapy designation from the FDA for non-cirrhotic MASH with moderate to advanced liver fibrosis [7] Upcoming Event - A virtual key opinion leader (KOL) event is scheduled for May 29, 2025, featuring Dr. Rohit Loomba, who will discuss the potential of combining denifanstat with resmetirom for treating advanced MASH [1][2] - The event will include an overview of the planned Phase 1 pharmacokinetic clinical trial for the combination therapy and a live Q&A session [3][4] Clinical Development - The development program builds on positive results from the Phase 2b FASCINATE-2 clinical trial of denifanstat in MASH F2-F3 patients, particularly those at the advanced F3 stage [2][3] - Preclinical data indicate a synergistic effect of combining a FASN inhibitor with resmetirom on liver disease markers, showing improved NAS and hepatic collagen content compared to single agents [3] Disease Context - MASH is a severe liver disease affecting over 115 million people globally, with limited treatment options available [8] - The renaming of non-alcoholic fatty liver disease (NAFLD) to MASH aims to provide a more affirmative diagnosis and reduce stigma associated with the disease [8]
Sagimet Biosciences(SGMT) - 2025 Q1 - Quarterly Results
2025-05-08 10:05
Exhibit 99.2 Targeting Metabolic Dysfunction with Novel Therapies to Treat M ASH, Acne & Cancer May 2025 Forward-Looking Statements and Disclaimer This presentation contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Reform Act of 1995. All statements contained in this document, other than statements of historical facts or statements that relate to pre: conditions, including but not limited to, statements regarding possible or assumed fu ...
Sagimet Biosciences(SGMT) - 2025 Q1 - Quarterly Report
2025-05-08 10:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41742 Sagimet Biosciences Inc. (Exact name of registrant as specified in its charter) (State or other jurisdi ...
Sagimet Biosciences Reports First Quarter 2025 Financial Results and Provides Corporate Updates
GlobeNewswire News Room· 2025-05-08 10:00
Core Viewpoint - Sagimet Biosciences Inc. is advancing its clinical-stage biopharmaceutical development, particularly focusing on denifanstat for treating metabolic dysfunction associated steatohepatitis (MASH), with promising results from recent clinical trials and plans for further studies [2][5]. Clinical Development - The Phase 2b FASCINATE-2 trial of denifanstat in MASH patients showed successful results, especially in F3 stage patients [2]. - Denifanstat demonstrated similar pharmacokinetic characteristics and tolerability in a Phase 1 trial for patients with and without hepatic impairment [2]. - A Phase 1 clinical trial to evaluate the combination of denifanstat and resmetirom is anticipated to start in the second half of 2025, with results expected in the first half of 2026 [3][12]. Preclinical Data - Preclinical data presented at EASL 2024 indicated that the combination of a FASN inhibitor (TVB-3664) and resmetirom significantly improved liver disease markers, achieving an 80% improvement in NAS compared to 33% and 25% improvements from monotherapies [3][6]. Financial Results - For the quarter ended March 31, 2025, Sagimet reported a net loss of $18.2 million, compared to a net loss of $6.6 million for the same period in 2024 [8][16]. - Research and development expenses increased to $15.3 million from $5.3 million year-over-year, while general and administrative expenses rose to $4.5 million from $3.5 million [12][16]. - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $144.6 million [12][17]. Corporate Updates - The company successfully completed end-of-Phase 2 interactions with the FDA in October 2024, paving the way for Phase 3 trials in MASH [5]. - Leadership changes include George Kemble transitioning to non-executive Chair of the Board and the appointment of Beth Seidenberg as Lead Independent Director [5]. Industry Context - MASH is a severe liver disease affecting over 115 million people globally, with limited treatment options available [10]. - The renaming of NAFLD to MASLD and NASH to MASH aims to reduce stigma and improve diagnosis [10].