Madrigal Pharmaceuticals Closer to EU Approval for First MASH Treatment, Rezdiffra
Although the European Commission is not obligated to follow this recommendation, a final decision is anticipated in August 2025. Following this announcement, shares of Madrigal (MDGL) opened 0.5% higher on June 20. The Pennsylvania-headquartered company has a market capitalization of ~$6.3 billion and also has a therapy portfolio for cardiovascular and metabolic diseases.
A scientist examining the results of a Phase III clinical trial for non-alcoholic steatohepatitis.
Rezdiffra is already approved and available in the US for adults with noncirrhotic MASH who have moderate to advanced liver fibrosis. If approved in Europe, Rezdiffra would hold the same indication. Madrigal secured accelerated approval from the US FDA for Rezdiffra in March 2024, making it the first MASH treatment in the US market. MASH is a form of non-alcoholic fatty liver disease/NAFLD and is a significant health concern, being the leading cause of liver transplantation in women and the second leading cause of all liver transplantations in the US.
Madrigal Pharmaceuticals Inc. (NASDAQ:MDGL) is a biopharmaceutical company that delivers novel therapeutics for metabolic dysfunction-associated steatohepatitis/MASH in the US.
While we acknowledge the potential of MDGL as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the .
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Disclosure: None. This article is originally published at Insider Monkey.
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