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Sagimet Biosciences Inc. (Nasdaq: SGMT) is a clinical-stage biopharmaceutical company committed to discovering and developing novel therapeutics targeting dysfunctional metabolic pathways. The company's lead drug candidate, denifanstat, is an innovative, oral, once-daily pill that selectively inhibits fatty acid synthase (FASN). This inhibitor is specifically designed for the treatment of nonalcoholic steatohepatitis (NASH), a severe and progressive liver disease.
Denifanstat has recently achieved significant milestones. The FASCINATE-2 Phase 2b clinical trial demonstrated statistically significant improvements in primary and multiple secondary endpoints at week 52 in 168 NASH patients with stage 2 or 3 fibrosis. The results showed that denifanstat was generally well-tolerated, with the majority of adverse events being mild to moderate. Importantly, no treatment-related serious adverse events were observed.
Under an exclusive license agreement, Gannex Pharma Co., Ltd., a wholly-owned subsidiary of Ascletis Pharma Inc., holds the rights to develop, manufacture, and commercialize denifanstat (referred to as ASC40) in Greater China.
Founded in 2019, Gannex focuses on the R&D and commercialization of novel drugs for NASH, with three clinical stage candidates targeting different pathways—FASN, THRβ, and FXR. Ascletis Pharma Inc., listed on the Hong Kong Stock Exchange, leads the global effort in viral diseases, NASH, and oncology, with several advanced drug candidates in its pipeline.
Sagimet's commitment to addressing unmet medical needs in metabolic dysfunction has placed it at the forefront of NASH treatment innovation. The company's current projects and partnerships highlight its potential for significant impact in the biopharmaceutical industry.
Sagimet Biosciences Inc. (Nasdaq: SGMT) announced an upcoming oral presentation at the 8th Annual MASH Drug Development Summit in Boston, scheduled for September 24-26, 2024. The presentation, titled "Demonstrating denifanstat's differentiated approach in MASH with mechanistic and clinical data showing direct anti-fibrotic activity," will be given by Dr. Marie O'Farrell, Senior Vice President of Research and Development at Sagimet.
The presentation will highlight denifanstat's anti-fibrotic activity in metabolic dysfunction-associated steatohepatitis (MASH). It is part of the session "Showcasing Antifibrotic Progress, Past Learnings & Innovations to Supercharge MASH Drug Development" and is scheduled for Thursday, September 26, 2024, from 4:15 to 4:45 PM ET.
Sagimet Biosciences (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing fatty acid synthase (FASN) inhibitors, announced its participation in two upcoming investor conferences. The company will engage in fireside chats at:
- The H.C. Wainwright 26th Annual Global Investment Conference on September 10, 2024, at 11:00 a.m. ET in New York
- The 2024 Cantor Global Healthcare Conference on September 17, 2024, at 9:10 a.m. ET in New York
Webcasts of both events will be available on Sagimet's website, with replays accessible for 90 days after the live events. These conferences provide Sagimet an opportunity to showcase its progress in developing novel therapies targeting dysfunctional metabolic and fibrotic pathways.
Sagimet Biosciences (Nasdaq: SGMT) reported Q2 2024 financial results and corporate updates. Key highlights include:
1. Presentation of denifanstat Phase 2b FASCINATE-2 52-week data at EASL Congress, showing significant fibrosis reduction in advanced F2 and F3 patients.
2. Preparations for Phase 3 clinical development of denifanstat in MASH patients in H2 2024.
3. Appointment of two biotech industry leaders to the Board of Directors.
4. Cash position of $188.5 million as of June 30, 2024, expected to fund operations through 2025.
5. Q2 2024 financial results: R&D expense $6.3 million, G&A expense $4.3 million, net loss $8.1 million.
Sagimet Biosciences Inc. (Nasdaq: SGMT) has appointed Anne Phillips and Jennifer Jarrett to its Board of Directors, effective August 1, 2024. This strategic move comes as Sagimet prepares to initiate Phase 3 clinical development of denifanstat in MASH this year. Dr. Phillips brings over 25 years of pharmaceutical industry experience, including regulatory affairs expertise from her tenure at Novo Nordisk. Ms. Jarrett contributes significant financial and operational experience from her roles at Arcus Biosciences and Uber. Both appointees express enthusiasm for Sagimet's potential, particularly regarding denifanstat's unique fat synthesis inhibition mechanism for addressing MASH. These additions aim to strengthen Sagimet's leadership as it advances its pipeline of FASN-directed therapeutics.
Sagimet Biosciences, a clinical-stage biopharmaceutical company, announced a conference call and webcast on June 13, 2024, at 9:30 AM PT / 12:30 PM ET to discuss data from their Phase 2b FASCINATE-2 clinical trial.
The trial evaluates denifanstat, an oral, once-daily FASN inhibitor, in metabolic dysfunction-associated steatohepatitis (MASH) patients. Dr. Rohit Loomba will present the data, which was recently shared at the EASL Congress in Milan, Italy.
Participants can join the live event via webcast or dial-in using provided numbers. A chat-based Q&A session will follow the presentation.
Sagimet Biosciences presented promising data from the Phase 2b FASCINATE-2 clinical trial of denifanstat at EASL 2024. Denifanstat significantly improved liver fibrosis and MASH resolution in patients with metabolic dysfunction-associated steatohepatitis (MASH), achieving primary and secondary endpoints.
Key results: 38% of denifanstat patients had a ≥2-point reduction in NAS without worsening fibrosis, compared to 16% for placebo. For fibrosis improvement by ≥1 stage without worsening MASH, results were 30% for denifanstat vs 14% for placebo. Denifanstat was well tolerated with no serious adverse events.
Based on these findings, Sagimet plans to initiate a Phase 3 registrational program for denifanstat in MASH with fibrosis in the latter half of 2024.
Sagimet Biosciences (Nasdaq: SGMT), a clinical-stage biopharmaceutical company, will host a virtual investor and analyst day on May 23, 2024, at 1:00 PM ET.
The event will feature Dr. Scott Friedman from Icahn School of Medicine at Mount Sinai, who will discuss the unmet needs and treatment landscape for patients with metabolic dysfunction-associated steatohepatitis (MASH). Additionally, the event will cover topline data from Sagimet's FASCINATE-2 Phase 2b clinical trial for its lead drug candidate, denifanstat, an oral FASN inhibitor. A live Q&A session will follow the presentation.
Sagimet Biosciences (Nasdaq: SGMT) reported its Q1 2024 financial results, highlighting significant progress in the development of denifanstat for metabolic dysfunction-associated steatohepatitis (MASH). The company announced positive results from the Phase 2b FASCINATE-2 trial, meeting primary efficacy endpoints and demonstrating significant fibrosis reduction. Full trial results will be presented at the EASL Congress in June 2024. Sagimet plans a Phase 3 trial following an FDA meeting in Q2 2024. The company raised $104.7 million from a public offering and holds $193.7 million in cash as of March 31, 2024, ensuring a cash runway through 2025. Research and development expenses increased to $5.3 million, while net losses remained consistent at $6.6 million year-over-year.
Sagimet Biosciences Inc. announced the oral presentation of denifanstat Phase 2b FASCINATE-2 study data at the EASL International Liver Congress 2024. The study demonstrated significant fibrosis improvement and MASH resolution in patients with F2 or F3 fibrosis.
Sagimet Biosciences Inc. announced the appointment of Thierry Chauche as Chief Financial Officer. Chauche brings over 20 years of financial and biopharma experience to the role. The company granted him an inducement stock option worth $2 million. Additionally, Sagimet approved inducement grants of stock options for four other newly-hired employees.
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