Madrigal Pharmaceuticals: Unlocking European Market Potential with Rezdiffra Approval

Madrigal Pharmaceuticals has received conditional market authorization from the European Commission for Rezdiffra, the first approved MASH therapy in Europe. The approval aligns with European treatment guidelines and is expected to drive significant revenue growth. Analyst Thomas Smith has maintained his bullish stance on MDGL stock with a Buy rating, citing strong clinical, regulatory, and commercial execution. The European market is seen as a crucial growth driver for the company.

Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) has received conditional marketing authorization from the European Commission for Rezdiffra, marking a significant milestone in the treatment of metabolic dysfunction-associated steatohepatitis (MASH). This approval positions Rezdiffra as the first and only approved therapy for MASH in the European Union (EU), aligning with the European treatment guidelines [1].

The conditional marketing authorization was based on the positive results from the pivotal Phase 3 MAESTRO-NASH trial, which demonstrated that Rezdiffra reduced fibrosis, resolved MASH, and improved key noninvasive tests. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) adopted in June 2025 [1]. Rezdiffra is expected to be launched in Germany in the fourth quarter of 2025, with subsequent launches in other EU countries [1].

Rezdiffra is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. It is already included in European MASH treatment guidelines as a first-line treatment. Madrigal estimates that approximately 370,000 patients with MASH with moderate to advanced fibrosis are currently diagnosed and under the care of a liver specialist across Europe [1].

Analyst Thomas Smith has maintained a bullish stance on MDGL stock with a Buy rating, citing strong clinical, regulatory, and commercial execution. The European market is seen as a crucial growth driver for the company, with the approval of Rezdiffra expected to drive significant revenue growth [1].

The approval of Rezdiffra is a transformational moment for the European MASH community, offering a new treatment option for patients with moderate to advanced fibrosis. The approval follows a positive opinion from the CHMP and is valid in all 27 Member States of the EU, as well as in Iceland, Liechtenstein, and Norway [1].

Madrigal Pharmaceuticals, Inc. is a biopharmaceutical company focused on delivering novel therapeutics for MASH, a liver disease with high unmet medical need. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3) [1].

References:
[1] https://www.biospace.com/press-releases/madrigal-receives-european-commission-approval-for-rezdiffra-resmetirom-for-the-treatment-of-mash-with-moderate-to-advanced-liver-fibrosis