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CONSHOHOCKEN, Pa. - Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced Tuesday that the European Commission has granted conditional marketing authorization for Rezdiffra (resmetirom) to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis. The news continues to fuel the company’s impressive market performance, with the stock showing a 52% return over the past year and currently trading near its 52-week high of $394. According to InvestingPro analysis, the company maintains a healthy financial position with a current ratio of 5.11, indicating strong liquidity.
The approval makes Rezdiffra the first and only medication approved for MASH treatment in the European Union. The company plans to launch the drug in Germany in the fourth quarter of 2025, followed by other European markets on a country-by-country basis. This expansion potential has caught analysts’ attention, with InvestingPro data showing 10 analysts recently revising their earnings estimates upward. For detailed analysis and additional insights, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
The EC’s decision was based on results from the Phase 3 MAESTRO-NASH trial, which showed Rezdiffra reduced fibrosis, resolved MASH, and improved various liver health indicators. At the one-year mark, 91% of patients receiving the 100 mg dose achieved improvement or stabilization of liver stiffness as measured by vibrational-controlled transient elastography.
"This approval of Rezdiffra marks a historic breakthrough for patients in Europe living with MASH, a serious and progressive liver disease," said Bill Sibold, Chief Executive Officer of Madrigal.
MASH, formerly known as nonalcoholic steatohepatitis (NASH), is a serious liver condition that can progress to cirrhosis and liver failure. It is the fastest-growing indication for liver transplantation in Europe. Madrigal estimates approximately 370,000 patients with MASH with moderate to advanced fibrosis are currently diagnosed and under specialist care across Europe. The company’s revenue growth reflects this market opportunity, with InvestingPro showing a remarkable revenue increase and a strong gross profit margin of 96%. The stock currently trades with moderate debt levels and maintains a healthy balance sheet, crucial factors for its expansion plans.
Rezdiffra is a once-daily, oral, liver-directed THR-β agonist designed to target underlying causes of MASH. The drug previously received accelerated approval from the U.S. Food and Drug Administration in March 2024.
A conditional marketing authorization is granted when the benefit to public health of immediate availability outweighs the risk that additional data are still required, according to the press release statement.
In other recent news, Madrigal Pharmaceuticals reported impressive second-quarter earnings, with Rezdiffra sales reaching $212.8 million, a 55% increase from the previous quarter. This performance significantly exceeded Goldman Sachs’ estimates of $150.9 million and the FactSet consensus of $159.4 million. Additionally, Madrigal Pharmaceuticals has secured a global license agreement with CSPC Pharmaceutical Group for SYH2086, an oral GLP-1 receptor agonist, involving an upfront payment of $120 million and up to $2 billion in milestone payments. The transaction is expected to close in the fourth quarter of 2025, subject to regulatory approval.
Analyst activity has been notable, with Goldman Sachs reiterating a Buy rating and a $567 price target for Madrigal Pharmaceuticals. Piper Sandler also reiterated an Overweight rating and a $400 price target, expressing confidence in the launch of Rezdiffra for MASH. Furthermore, Jefferies raised its price target to $502, following a new patent extension for Rezdiffra, which now lasts until February 2045. These developments highlight ongoing interest and confidence from analysts in Madrigal Pharmaceuticals’ future performance.
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