European regulator recommends approval of Madrigal’s MASH drug

CONSHOHOCKEN, Pa. - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Madrigal Pharmaceuticals’ (NASDAQ:MDGL) resmetirom for treating adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis. The $6.28 billion market cap company maintains a strong financial position, with InvestingPro data showing more cash than debt and a healthy current ratio of 5.91.

The European Commission is expected to make a final decision on the drug, marketed as Rezdiffra, in August 2025. If approved, resmetirom would become the first medication for MASH patients in the European Union. According to InvestingPro analysis, analysts project substantial revenue growth of 276% for fiscal year 2025, reflecting high expectations for the drug’s market potential.

The CHMP recommendation follows the U.S. Food and Drug Administration’s accelerated approval of Rezdiffra in March 2024 for treating adults with noncirrhotic MASH with moderate to advanced liver fibrosis.

The committee’s positive opinion was based on resmetirom’s performance in the Phase 3 MAESTRO-NASH trial, which achieved both fibrosis reduction and MASH resolution primary endpoints.

"MASH is the fastest-growing indication for liver transplantation in Europe," said Bill Sibold, Chief Executive Officer of Madrigal, in a press release statement.

MASH, formerly known as nonalcoholic steatohepatitis (NASH), is a serious liver disease that can progress to cirrhosis, liver failure, and liver cancer. Patients with moderate to advanced liver fibrosis have a 10-17 times higher risk of liver-related mortality compared to patients without fibrosis.

Resmetirom is a once-daily, oral, liver-directed THR-β agonist designed to target underlying causes of MASH. The company is currently conducting the MAESTRO-NASH OUTCOMES trial to evaluate the drug’s effect on disease progression in patients with compensated MASH cirrhosis. With a beta of -1.08, the stock often moves counter to market trends, making it an interesting portfolio diversification option. For deeper insights into Madrigal’s investment potential, including 8 additional ProTips and comprehensive financial analysis, visit InvestingPro.

In other recent news, Madrigal Pharmaceuticals reported a strong performance for the first quarter of 2025, surpassing earnings expectations. The company achieved an earnings per share (EPS) of -3.32, outperforming the anticipated -3.86, and reported revenue of $137.3 million, exceeding the forecasted $112.54 million. This represents a 33% increase in revenue quarter-over-quarter, driven by the success of their drug, ResDiffera. Analysts from Citi have maintained a Buy rating on Madrigal, with a price target of $456, following the company’s detailed review of two-year open-label data in F4C patients. Meanwhile, BofA Securities has reiterated its Underperform rating with a price target of $248, citing uncertainties in assessing the overall benefit of Rezdiffra. Citizens JMP analysts continue to hold a Market Outperform rating for Madrigal, maintaining a price target of $470. The company is also preparing for an upcoming event focused on Rezdiffra, which is expected to provide further insights into the treatment of Metabolic Associated Steatohepatitis (MASH). These developments reflect Madrigal’s ongoing efforts to solidify its position in the NASH treatment market.

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