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.

A healthcare professional wearing a health communications device discussing patient data with a colleague.

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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Disclosure: None.