Madrigal Pharmaceuticals Receives Conditional Marketing Authorization for Rezdiffra in Europe
ByAinvest
Wednesday, Aug 20, 2025 1:34 pm ET1min read
MDGL--
Rezdiffra is the first and only approved therapy in the EU for the treatment of MASH. The approval is based on positive results from the pivotal Phase 3 MAESTRO-NASH trial, which demonstrated Rezdiffra's ability to reduce fibrosis, resolve MASH, and improve key noninvasive tests. The drug is already included in European MASH treatment guidelines as a first-line treatment [1].
Madrigal plans to launch Rezdiffra in Germany in the fourth quarter of 2025, with subsequent launches in other EU countries following the completion of reimbursement procedures [1]. The drug's approval in Europe comes after a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June 2025.
MASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. 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]. Rezdiffra is designed to target key underlying causes of MASH and has shown favorable benefit-risk profiles in clinical trials.
The approval of Rezdiffra is expected to have a positive impact on Madrigal's stock price, given the significant market need for effective treatments for MASH. However, investors should also consider the risks associated with the company's forward-looking statements, including potential regulatory delays, challenges with commercial launch, and the need to raise sufficient capital to fund ongoing operations.
References:
[1] Madrigal Pharmaceuticals, Inc. (2025). Madrigal Receives European Commission Approval for Rezdiffra. Retrieved from 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
Madrigal Pharmaceuticals has received conditional marketing authorization from the European Commission for Rezdiffra, a treatment for noncirrhotic MASH with moderate to advanced liver fibrosis in adults. This approval allows for the drug to be marketed in the European Union. Madrigal's stock price is expected to be positively impacted by this news.
Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) has received conditional marketing authorization from the European Commission for Rezdiffra, a treatment for noncirrhotic MASH (Metabolic dysfunction-associated steatohepatitis) with moderate to advanced liver fibrosis in adults. This approval allows for the drug to be marketed in the European Union, marking a significant milestone in the treatment of MASH.Rezdiffra is the first and only approved therapy in the EU for the treatment of MASH. The approval is based on positive results from the pivotal Phase 3 MAESTRO-NASH trial, which demonstrated Rezdiffra's ability to reduce fibrosis, resolve MASH, and improve key noninvasive tests. The drug is already included in European MASH treatment guidelines as a first-line treatment [1].
Madrigal plans to launch Rezdiffra in Germany in the fourth quarter of 2025, with subsequent launches in other EU countries following the completion of reimbursement procedures [1]. The drug's approval in Europe comes after a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June 2025.
MASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. 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]. Rezdiffra is designed to target key underlying causes of MASH and has shown favorable benefit-risk profiles in clinical trials.
The approval of Rezdiffra is expected to have a positive impact on Madrigal's stock price, given the significant market need for effective treatments for MASH. However, investors should also consider the risks associated with the company's forward-looking statements, including potential regulatory delays, challenges with commercial launch, and the need to raise sufficient capital to fund ongoing operations.
References:
[1] Madrigal Pharmaceuticals, Inc. (2025). Madrigal Receives European Commission Approval for Rezdiffra. Retrieved from 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
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