Sagimet Biosciences Inc. develops clinical-stage fatty acid synthase (FASN) inhibitors for diseases tied to dysfunctional metabolic and fibrotic pathways. Company news centers on denifanstat, an oral FASN inhibitor studied in metabolic dysfunction-associated steatohepatitis (MASH) and moderate to severe acne, and TVB-3567, a second oral FASN inhibitor for acne.
Recurring updates include clinical and preclinical data presentations, FASCINATE-2 analyses, regulatory and license-partner developments, financial results, capital-structure disclosures, executive leadership changes, inducement grants, shareholder matters, and investor conference participation.
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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