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Madrigal Pharmaceuticals to Release Second-Quarter 2025 Financial Results and Host Webcast on August 5, 2025
Globenewswire· 2025-07-25 12:00
Core Viewpoint - Madrigal Pharmaceuticals, Inc. is set to release its second-quarter 2025 financial results on August 5, 2025, before the U.S. financial markets open [1] Company Overview - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [3] - The company's primary medication, Rezdiffra (resmetirom), is a once-daily oral THR-β agonist targeting the underlying causes of MASH and is the first FDA-approved treatment for MASH with moderate to advanced fibrosis [3] - An ongoing Phase 3 outcomes trial is assessing Rezdiffra for treating compensated MASH cirrhosis [3] Investor Relations - Following the financial results announcement, Madrigal's management will host a live webcast at 8 a.m. Eastern Time to discuss the financial and operational results [2] - The webcast will be accessible via the Investor Relations section of the Madrigal Pharmaceuticals website, with a recommendation for participants to register at least 15 minutes prior to the event [2]
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]
89bio Reports First Quarter 2025 Financial Results and Corporate Updates
Globenewswire· 2025-05-01 20:05
Core Insights - 89bio, Inc. is advancing its clinical-stage biopharmaceutical development, focusing on therapies for liver and cardiometabolic diseases, particularly targeting metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG) [11] Clinical Trials - The Phase 3 ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis trials are designed to support accelerated approval for treating patients with MASH, with topline data expected in 1H 2027 and 2028, respectively [1][5] - The ENTRUST trial for SHTG has been fully enrolled, with topline data anticipated in 1Q 2026 [1][5] - Pegozafermin has been recognized in a meta-analysis as one of the most effective agents for fibrosis improvement and MASH resolution, highlighting its potential in the market [2] Financial Position - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling approximately $638.8 million, an increase from $439.9 million at the end of 2024 [7][15] - The company completed a follow-on equity offering in 1Q 2025, generating gross proceeds of $287.5 million [4] - A $150 million credit facility with K2 HealthVentures has been established, with $35 million drawn down [4] Expenses and Losses - Research and development expenses for Q1 2025 were $64.4 million, up from $47.4 million in Q1 2024, primarily due to increased clinical development costs [8] - General and administrative expenses rose to $11.5 million in Q1 2025 from $9.8 million in Q1 2024, driven by higher personnel-related costs [9] - The net loss for Q1 2025 was reported at $71.3 million, compared to a net loss of $51.7 million in Q1 2024, attributed to higher R&D and G&A expenses [10]
Sagimet Biosciences Announces Upcoming Presentations at EASL Congress 2025
Newsfilter· 2025-04-23 12:00
Core Viewpoint - Sagimet Biosciences Inc. is advancing its clinical-stage drug denifanstat for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), with new data presentations scheduled at the EASL Congress 2025 [1][6]. Group 1: EASL Presentation Details - Three poster presentations will feature analyses from the Phase 2b FASCINATE-2 study of denifanstat, focusing on its efficacy in treating MASH [1]. - The first presentation will assess the MASH Resolution Index (MR-I) as a non-invasive biomarker for predicting histological response to denifanstat, indicating its potential to identify non-responders [2]. - The second presentation highlights the correlation between reduced plasma glycine- and taurine-conjugated bile acids and histological improvements in MASH patients treated with denifanstat [3]. - The third presentation discusses denifanstat's antifibrotic effects on collagen features linked to major adverse liver outcomes in high-risk patients [4]. Group 2: Company Overview - Sagimet is focused on developing fatty acid synthase (FASN) inhibitors, with denifanstat being its lead candidate, designed for once-daily oral administration [5]. - Denifanstat has received Breakthrough Therapy designation from the FDA for treating non-cirrhotic MASH with moderate to advanced liver fibrosis [6]. - The global prevalence of MASH is significant, affecting over 115 million people, with limited treatment options currently available [7].