Madrigal Pharmaceuticals stock rises as EU approves MASH treatment

Investing.com - Madrigal Pharmaceuticals (NASDAQ:MDGL) stock gained Wednesday after the European Commission approved its MASH treatment REZDIFFRA, making it the first approved medication for this liver condition in the European Union. The stock, which has delivered a remarkable 46% return over the past year, is currently trading near its 52-week high of $393.76.

The EC approved REZDIFFRA (resmetirom) "for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis" without requiring a liver biopsy. The approval is valid across all 27 EU countries plus Iceland, Liechtenstein, and Norway.

Madrigal plans to launch REZDIFFRA in Europe on a country-by-country basis, beginning with Germany in the fourth quarter of 2025. The company estimates approximately 370,000 moderate-to-advanced fibrosis diagnosed MASH patients in Europe are currently under liver specialist care.

Piper Sandler reiterated an Overweight rating on Madrigal stock with a $400.00 price target following the announcement. The firm called the approval "a key regulatory milestone" that could "further drive share gains."

REZDIFFRA represents the first and only approved MASH agent in the European Union, expanding Madrigal’s market beyond its ongoing U.S. launch of the treatment.

In other recent news, Madrigal Pharmaceuticals has received significant attention following the European Union’s approval of its Rezdiffra treatment for MASH, making it the first approved medication for this condition in the EU. The company plans to launch Rezdiffra in Germany in the fourth quarter of 2025, targeting patients with moderate to advanced liver fibrosis. Analysts have responded positively to these developments, with Jefferies raising its price target for Madrigal to $502, citing a new weight-based dosing patent for Rezdiffra that extends protection until 2045. Citizens JMP also increased its price target to $485, maintaining a Market Outperform rating. Meanwhile, Goldman Sachs reiterated its Buy rating with a $567 price target, even as Novo Nordisk (NYSE:NVO)’s Wegovy received approval for a similar indication, introducing new competitive dynamics. Piper Sandler expressed confidence in Madrigal’s launch strategy, reaffirming an Overweight rating and a $400 price target. These developments highlight strong investor interest and confidence in Madrigal’s future performance.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.