FDA Conditionally Approves Madrigal Pharmaceuticals' Resmetirom As First Treatment For Fatty Liver Disease With Scarring
Portfolio Pulse from Vandana Singh
The FDA has conditionally approved Madrigal Pharmaceuticals Inc.'s Rezdiffra (resmetirom) for noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring, marking the first FDA approval for a treatment of liver scarring due to fatty liver disease. The approval is based on the Phase 3 MAESTRO-NASH trial results, showing significant improvement in NASH resolution and liver scarring. Rezdiffra will be available in the U.S. in April through a limited specialty pharmacy network. Following the news, Madrigal Pharmaceuticals shares surged 10.67% to $269.55.
March 15, 2024 | 3:32 pm
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Madrigal Pharmaceuticals Inc. received FDA conditional approval for Rezdiffra, a treatment for NASH with liver scarring, leading to a 10.67% increase in its stock price to $269.55.
The FDA's conditional approval of Rezdiffra for the treatment of NASH with liver scarring is a significant milestone for Madrigal Pharmaceuticals, marking the first FDA approval for such a condition. This approval not only validates the company's research and development efforts but also opens up a substantial market opportunity, given the 6-8 million people in the U.S. with NASH and liver scarring. The positive trial results and the lack of a liver biopsy requirement for diagnosis could lead to widespread adoption of Rezdiffra, further boosting Madrigal's market position and financial outlook. The immediate positive reaction in the stock price reflects investor optimism about the drug's commercial potential and Madrigal's future revenue growth.
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