NASDAQ — Healthcare: Manufacturing, Biotechnology: Pharmaceutical Preparations
www.madrigalpharma.comMadrigal Pharmaceuticals anticipates a regulatory decision from the European Medicines Agency regarding Rezdiffra, expected mid-year 2025, which could lead to its approval in Europe.
fda decisionFred Craves, Ph.D., will retire from Madrigal Pharmaceuticals' Board in July 2025, marking the end of his significant contribution to the company since its inception.
management changeMadrigal Pharmaceuticals is expected to complete its Phase 3 MAESTRO-NAFLD-OLE clinical trial of Resmetirom (MGL-3196) in non-alcoholic fatty liver disease (NAFLD) by April 1, 2026. The open-label extension study is designed to evaluate the long-term safety and biomarker effects of Resmetirom, an oral thyroid hormone receptor-β agonist. The trial is recruiting approximately 1,000 participants. Resmetirom is being developed as a potential first-in-class therapy for NAFLD and non-alcoholic steatohepatitis (NASH).
trial completionMadrigal Pharmaceuticals is conducting the MAESTRO-NASH-OUTCOMES Phase 3 trial to evaluate resmetirom in patients with well-compensated NASH cirrhosis. The randomized, placebo-controlled study aims to assess the effect of resmetirom on clinical outcomes, including liver-related and cardiovascular mortality, liver transplant, and significant hepatic events. The trial is expected to complete by January 1, 2027. Resmetirom is an oral, once-daily thyroid hormone receptor-β agonist being developed for nonalcoholic steatohepatitis (NASH), a progressive liver disease with limited treatment options.
trial completionMadrigal Pharmaceuticals is expected to complete its Phase 3 clinical trial of MGL-3196 (Resmetirom) for patients with nonalcoholic steatohepatitis (NASH) and fibrosis by January 1, 2028. The study, involving 1,759 participants, aims to evaluate the efficacy and safety of Resmetirom, a thyroid hormone receptor-beta agonist, in improving liver histology in NASH patients with advanced fibrosis. The trial's results could impact the competitive landscape for NASH therapies, an area with significant unmet medical need.
trial completion