Madrigal Pharmaceuticals, Inc. 10-K filed Feb 19, 2026

Modified · Overview

We are a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (“MASH”), a serious liver disease with high unmet medical need that can lead to cirrhosis, liver failure , liver cancer, need for liver transplantation and premature mortality. MASH was previously known as nonalcoholic steatohepatitis (“NASH”). In 2023, global liver disease medical societies and patient groups came together to rename MASH is the disease, with the goal leading cause of establishing an affirmativeliver transplantation in women, non-stigmatizing name and diagnosis. The U.S. Food and Drug Administration (the “FDA”) considers the term NASH interchangeable with MASH. MASH is expected to become the second leading cause of all liver transplantation in the United States and is already the leading cause offastest-growing indication for liver transplantation among women in the United StatesEurope. Our medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed thyroid hormone receptor beta (“THR-β”) agonist designed to target key underlying causes of MASH. In March 2024, Rezdiffra became the first and only therapy approved by the FDA for patients with MASH and was commercially available in the United States beginning in April 2024. Following receipt of conditional marketing authorization (“CMA”) from the European Commission (“EC”), we launched Rezdiffra is indicatedin Germany in conjunction with diet September 2025. Rezdiffra was the first medication approved by both the FDA and exerciseEC for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent F2 to F3 fibrosis). We are also evaluating Rezdiffra in patients with stages F2 to F3 compensated MASH cirrhosis (consistent with F4c fibrosis) in our MAESTRO-NASH OUTCOMES trial, that, if successful, could expand the eligible patient population for Rezdiffra.