Madrigal Pharmaceuticals (MDGL) Is Up 7.4% After EU Approval of Rezdiffra as First MASH Therapy

• In August 2025, Madrigal Pharmaceuticals announced that the European Commission granted conditional marketing authorization for Rezdiffra (resmetirom), making it the first and only approved therapy in the EU for adults with noncirrhotic MASH with moderate to advanced liver fibrosis.
• This decision positions Rezdiffra to address a substantial unmet need in Europe, where approximately 370,000 patients are currently diagnosed and managed by liver specialists.
• We'll examine how becoming the sole approved MASH therapy in Europe could change Madrigal Pharmaceuticals' future outlook and growth narrative.

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Madrigal Pharmaceuticals Investment Narrative Recap

To own shares in Madrigal Pharmaceuticals, you need to believe Rezdiffra will capture meaningful market share as the first and only approved therapy for noncirrhotic MASH in Europe, translating to significant revenue from a large, previously untapped patient population. The recent EU approval is a clear milestone and enhances the company’s key short-term catalyst, rapid international uptake, while somewhat reducing, but not eliminating, risks tied to execution, competitive pressure, and future reimbursement challenges.

One related announcement worth highlighting is the Committee for Medicinal Products for Human Use (CHMP) recommendation in June 2025, which set the stage for the European Commission’s approval. This sequence of regulatory wins, supported by positive clinical trial data, ties directly to Madrigal’s potential for accelerated revenue growth as Rezdiffra launches across European markets in the coming months.

However, investors should also be aware that, despite the recent progress, international expansion brings added uncertainty on how quickly ...

Read the full narrative on Madrigal Pharmaceuticals (it's free!)

Madrigal Pharmaceuticals' narrative projects $2.5 billion revenue and $822.9 million earnings by 2028. This requires 68.6% yearly revenue growth and a $1.1 billion earnings increase from the current -$281.9 million.

Uncover how Madrigal Pharmaceuticals' forecasts yield a $461.43 fair value, a 6% upside to its current price.

Exploring Other Perspectives

Simply Wall St Community members provided three fair value estimates for Madrigal Pharmaceuticals ranging from US$460 to US$3,126. With this diversity of opinion, consider how competitive threats could influence long-term growth and market share as you weigh different viewpoints.

Explore 3 other fair value estimates on Madrigal Pharmaceuticals - why the stock might be worth just $460.00!

Build Your Own Madrigal Pharmaceuticals Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Madrigal Pharmaceuticals research is our analysis highlighting 2 key rewards that could impact your investment decision.
• Our free Madrigal Pharmaceuticals research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Madrigal Pharmaceuticals' overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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