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Madrigal Gets Conditional Nod for MASH Drug Rezdiffra in EU
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Key Takeaways
Madrigal gained conditional EU approval for Rezdiffra to treat adults with noncirrhotic MASH.
The EU nod to Rezdiffra followed positive phase III MAESTRO-NASH data showing fibrosis and MASH benefits.
Despite approval, MDGL stock fell as investors eyed competition from Novo Nordisk's Wegovy.
Madrigal Pharmaceuticals (MDGL - Free Report) announced that the European Commission (EC) has granted a conditional marketing authorization to Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver fibrosis.
Following the latest nod, Rezdiffra became the first and only therapy to be approved for the treatment of MASH in the European Union (EU). The approval was based on Rezdiffra’s favorable benefit-risk profile, including positive data from the pivotal phase III MAESTRO-NASH study, which achieved both fibrosis reduction and MASH resolution primary endpoints.
The first European launch of Rezdiffra is expected in the fourth quarter of 2025, starting with Germany. The drug is already included in European MASH treatment guidelines as a first-line treatment.
The nod in the EU was expected as the Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion recommending approval of Rezdiffra for the treatment of MASH with moderate-to-advanced liver fibrosis in June.
MDGL's Price Performance
Year to date, shares of Madrigal have rallied 23% compared with the industry’s rise of 9.1%.
Image Source: Zacks Investment Research
Why MDGL Stock Was Down Despite EU Nod to Rezdiffra
Despite the conditional nod to Rezdiffra from the EC, shares of Madrigal were down 3% on Aug. 19 as investors seemed concerned about potential competition from Novo Nordisk’s (NVO - Free Report) blockbuster GLP-1 drug, Wegovy (semaglutide 2.4 mg).
Earlier this month, the FDA granted an accelerated approval to Wegovy for the treatment of noncirrhotic MASH in adults with moderate-to-advanced liver fibrosis in combination with a reduced-calorie diet and increased physical activity.
Per NVO, Wegovy has now become the first and only GLP-1 therapy approved for MASH, marking a major milestone in liver care. Wegovy is one of the key revenue drivers for Novo Nordisk and holds a dominant position in the obesity market.
Per a Wall Street analyst, with its established safety profile and wide benefits in metabolic disease, Wegovy is likely to become a go-to treatment for MASH, paving the way for other GLP-1 drugs upon potential approval.
We note that Rezdiffra received an accelerated approval from the FDA in March 2024 for treating adults with noncirrhotic MASH with moderate-to-advanced fibrosis.
As the FDA approved Rezdiffra under the accelerated pathway, the continued approval will be based on promising long-term safety and efficacy data from the pivotal phase III MAESTRO-NASH biopsy study.
Rezdiffra's commercial launch is off to a strong start in the United States, driven by early patient demand for the drug. In the second quarter of 2025, Rezdiffra generated sales worth $212.8 million, reflecting a sequential increase of almost 55%. Per management, more than 23,000 patients are currently receiving Rezdiffra treatment as of June 30, 2025.
In the past 60 days, estimates for Avadel Pharmaceuticals’ earnings per share have increased from 17 cents to 26 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 72 cents to 88 cents. Year to date, AVDL stock has rallied 30.3%.
Avadel Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, delivering an average surprise of 119.64%.
In the past 60 days, estimates for Rigel Pharmaceuticals’ earnings per share have increased from $2.25 to $4.26 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.60 to $2.68. Year to date, shares of RIGL have surged 131.5%.
Rigel Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 1,840.49%.
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Madrigal Gets Conditional Nod for MASH Drug Rezdiffra in EU
Key Takeaways
Madrigal Pharmaceuticals (MDGL - Free Report) announced that the European Commission (EC) has granted a conditional marketing authorization to Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver fibrosis.
Following the latest nod, Rezdiffra became the first and only therapy to be approved for the treatment of MASH in the European Union (EU). The approval was based on Rezdiffra’s favorable benefit-risk profile, including positive data from the pivotal phase III MAESTRO-NASH study, which achieved both fibrosis reduction and MASH resolution primary endpoints.
The first European launch of Rezdiffra is expected in the fourth quarter of 2025, starting with Germany. The drug is already included in European MASH treatment guidelines as a first-line treatment.
The nod in the EU was expected as the Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion recommending approval of Rezdiffra for the treatment of MASH with moderate-to-advanced liver fibrosis in June.
MDGL's Price Performance
Year to date, shares of Madrigal have rallied 23% compared with the industry’s rise of 9.1%.
Image Source: Zacks Investment Research
Why MDGL Stock Was Down Despite EU Nod to Rezdiffra
Despite the conditional nod to Rezdiffra from the EC, shares of Madrigal were down 3% on Aug. 19 as investors seemed concerned about potential competition from Novo Nordisk’s (NVO - Free Report) blockbuster GLP-1 drug, Wegovy (semaglutide 2.4 mg).
Earlier this month, the FDA granted an accelerated approval to Wegovy for the treatment of noncirrhotic MASH in adults with moderate-to-advanced liver fibrosis in combination with a reduced-calorie diet and increased physical activity.
Per NVO, Wegovy has now become the first and only GLP-1 therapy approved for MASH, marking a major milestone in liver care. Wegovy is one of the key revenue drivers for Novo Nordisk and holds a dominant position in the obesity market.
Per a Wall Street analyst, with its established safety profile and wide benefits in metabolic disease, Wegovy is likely to become a go-to treatment for MASH, paving the way for other GLP-1 drugs upon potential approval.
We note that Rezdiffra received an accelerated approval from the FDA in March 2024 for treating adults with noncirrhotic MASH with moderate-to-advanced fibrosis.
As the FDA approved Rezdiffra under the accelerated pathway, the continued approval will be based on promising long-term safety and efficacy data from the pivotal phase III MAESTRO-NASH biopsy study.
Rezdiffra's commercial launch is off to a strong start in the United States, driven by early patient demand for the drug. In the second quarter of 2025, Rezdiffra generated sales worth $212.8 million, reflecting a sequential increase of almost 55%. Per management, more than 23,000 patients are currently receiving Rezdiffra treatment as of June 30, 2025.
Madrigal Pharmaceuticals, Inc. Price
Madrigal Pharmaceuticals, Inc. price | Madrigal Pharmaceuticals, Inc. Quote
MDGL's Zacks Rank and Stocks to Consider
Madrigal currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the drug sector are Avadel Pharmaceuticals (AVDL - Free Report) and Rigel Pharmaceuticals (RIGL - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Avadel Pharmaceuticals’ earnings per share have increased from 17 cents to 26 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 72 cents to 88 cents. Year to date, AVDL stock has rallied 30.3%.
Avadel Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, delivering an average surprise of 119.64%.
In the past 60 days, estimates for Rigel Pharmaceuticals’ earnings per share have increased from $2.25 to $4.26 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.60 to $2.68. Year to date, shares of RIGL have surged 131.5%.
Rigel Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 1,840.49%.