Metabolic dysfunction-associated steatohepatitis (MASH)

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Akero Therapeutics to be Acquired by Novo Nordisk for up to $5.2 Billion
Globenewswire· 2025-10-09 10:01
Shareholders to Receive $54 Per Share in Cash and CVR of $6 Per Share Advances Akero’s Mission of Bringing Novel Therapies to Patients with High Unmet Medical Needs SOUTH SAN FRANCISCO, Calif., Oct. 09, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (“Akero”) (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that it has entered into a definitive agreement to be acquired by Novo N ...
Madrigal Pharmaceuticals to Participate in Morgan Stanley 23rd Annual Global Healthcare Conference
Globenewswire· 2025-09-03 12:00
Group 1 - Madrigal Pharmaceuticals, Inc. will participate in the Morgan Stanley 23 Annual Global Health Care Conference on September 8, 2025, at 7:45 A.M. EDT [1] - The presentation will be available via live webcast and a replay will be accessible after the event [1] Group 2 - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [2] - The company's medication, Rezdiffra (resmetirom), is the first and only FDA and European Commission approved treatment for MASH with moderate to advanced fibrosis (F2 to F3) [2] - An ongoing Phase 3 outcomes trial is assessing Rezdiffra for the treatment of compensated MASH cirrhosis (F4c) [2]
Galectin Therapeutics Reports Financial Results for the Quarter Ended June 30, 2025 and Provides Business Update
Globenewswire· 2025-08-14 12:00
NORCROSS, Ga., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three and six months ended June 30, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, stated "We are encouraged by the continued analysis of data from our NAVIGATE trial , which further supports the clinical profile of belapectin in patients with ...
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]
Madrigal Pharmaceuticals Secures $500 Million in Senior Secured Credit from Blue Owl Managed Funds to Further Extend Leadership Position in MASH
GlobeNewswire News Room· 2025-07-22 12:00
CONSHOHOCKEN, Pa., July 22, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction- associated steatohepatitis (MASH), today announced that it has entered into a $500 million senior secured credit facility with funds managed by Blue Owl Capital (NYSE: OWL), a leading alternative asset manager, to primarily advance Madrigal's pipeline to further extend its leadership position in MASH. The non-dilut ...
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].