Madrigal Pharmaceuticals, Inc. develops and commercializes therapies for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease that can progress to cirrhosis and liver failure. Its principal medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed thyroid hormone receptor beta agonist approved by the FDA and European Commission for MASH with moderate to advanced fibrosis.
Company news regularly covers Rezdiffra sales and patient adoption, quarterly financial results, regulatory and clinical development updates, and pipeline expansion through licensed assets such as ARO-PNPLA3, a clinical-stage siRNA program targeting PNPLA3, and an oral GLP-1 receptor agonist program. Madrigal also issues recurring corporate-governance updates, including Nasdaq inducement awards under its employee equity plans.
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Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced on April 18, 2023, that the FDA granted Breakthrough Therapy designation for its drug resmetirom, aimed at treating nonalcoholic steatohepatitis (NASH) with liver fibrosis. The company also revealed that the Phase 3 MAESTRO-NASH trial has completed enrollment, targeting approximately 1,750 patients. CEO Paul Friedman indicated that the designation reflects the FDA's acknowledgment of resmetirom's potential as a significant therapeutic option for NASH. The company expects to file a New Drug Application (NDA) for resmetirom in Q2 2023 based on positive liver fibrosis outcomes from the ongoing trials. Madrigal is committed to demonstrating resmetirom's efficacy through multiple Phase 3 studies, including MAESTRO-NASH-OUTCOMES, which is vital for regulatory approval.