Madrigal Pharmaceuticals, Inc. (MDGL)'s Rezdiffra Hits 51% Liver Stiffness Reduction in Phase 3

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Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) is leading innovation in treating metabolic dysfunction-associated steatohepatitis (MASH), previously known as NASH. It’s FDA-approved drug, Rezdiffra (resmetirom), is the first oral, liver-targeted thyroid hormone receptor-β agonist for MASH with moderate to advanced fibrosis (F2–F3). It is also being tested in compensated MASH cirrhosis patients.

At the 2025 EASL Congress, Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) presented promising two-year data from its Phase 3 MAESTRO-NAFLD-1 trial, showing Rezdiffra significantly reduced liver stiffness and lowered the risk of liver decompensation in F4c patients. Notably, 51% of participants had a ≥25% reduction in liver stiffness, and 65% of those with baseline portal hypertension moved to lower-risk categories. Safety remained consistent with prior results.

Looking ahead, the MAESTRO-NASH OUTCOMES trial, expected to read out in 2027, will evaluate Rezdiffra’s ability to reduce liver-related events in compensated cirrhosis patients. Meanwhile, regulatory momentum continues: the EMA’s CHMP issued a positive opinion in June 2025, with potential EU approval expected by August. Rezdiffra would then be the first MASH treatment approved in both the U.S. and Europe.

Further solidifying its position, Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) secured a new U.S. patent for Rezdiffra’s dosing rights in July 2025, enhancing its intellectual property and global commercialization strategy.

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