Latest news with #MDGL
Business Insider
2 days ago
- Business
- Business Insider
Madrigal gets conditional marketing authorization for Rezdiffra from EC
Madrigal Pharmaceuticals (MDGL) announced that the European Commission has granted conditional marketing authorization for Rezdiffra for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Yahoo
27-07-2025
- Business
- Yahoo
Madrigal Pharmaceuticals, Inc. (MDGL)'s Rezdiffra Hits 51% Liver Stiffness Reduction in Phase 3
We recently compiled a list of Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) is leading innovation in treating metabolic dysfunction-associated steatohepatitis (MASH), previously known as NASH. It's FDA-approved drug, Rezdiffra (resmetirom), is the first oral, liver-targeted thyroid hormone receptor-β agonist for MASH with moderate to advanced fibrosis (F2–F3). It is also being tested in compensated MASH cirrhosis patients. At the 2025 EASL Congress, Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) presented promising two-year data from its Phase 3 MAESTRO-NAFLD-1 trial, showing Rezdiffra significantly reduced liver stiffness and lowered the risk of liver decompensation in F4c patients. Notably, 51% of participants had a ≥25% reduction in liver stiffness, and 65% of those with baseline portal hypertension moved to lower-risk categories. Safety remained consistent with prior results. Looking ahead, the MAESTRO-NASH OUTCOMES trial, expected to read out in 2027, will evaluate Rezdiffra's ability to reduce liver-related events in compensated cirrhosis patients. Meanwhile, regulatory momentum continues: the EMA's CHMP issued a positive opinion in June 2025, with potential EU approval expected by August. Rezdiffra would then be the first MASH treatment approved in both the U.S. and Europe. A healthcare professional wearing a health communications device discussing patient data with a colleague. Further solidifying its position, Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) secured a new U.S. patent for Rezdiffra's dosing rights in July 2025, enhancing its intellectual property and global commercialization strategy. While we acknowledge the potential of GOOGL as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
25-07-2025
- Business
- Yahoo
Madrigal (MDGL) Secures $500M to Fuel MASH Pipeline Expansion
Madrigal Pharmaceuticals (NASDAQ:MDGL) is one of the best biotech stocks to buy according to billionaire Steve Cohen. On July 22, MDGL announced a $500 million senior secured credit facility with Blue Owl Capital Inc. (NYSE:OWL), including a $350 million initial term loan and a $150 million delayed draw option through 2027. A doctor wearing a lab coat in a research laboratory, holding up a flask of a potential biotechnology therapeutic solution. The non-dilutive funding will refinance $115 million in existing debt and support strategic growth, with potential for an additional $250 million. Madrigal maintains a strong current ratio of 5.91, signaling solid liquidity. The capital will primarily advance Madrigal's pipeline for metabolic dysfunction-associated steatohepatitis (MASH), led by its FDA-approved drug Rezdiffra—the first treatment for MASH with moderate to advanced fibrosis. A Phase 3 trial is underway to evaluate Rezdiffra for compensated MASH cirrhosis. With strong launch momentum and a patent expected to extend protection through 2044, Madrigal is positioned to lead in MASH therapeutics. Madrigal Pharmaceuticals (NASDAQ:MDGL) is a biotech company that develops and commercializes novel therapies for metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH). While we acknowledge the potential of MDGL as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: and Goldman Sachs REIT Stocks: Top 12 Stock Picks. Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
25-07-2025
- Business
- Yahoo
Madrigal (MDGL) Secures $500M to Fuel MASH Pipeline Expansion
Madrigal Pharmaceuticals (NASDAQ:MDGL) is one of the best biotech stocks to buy according to billionaire Steve Cohen. On July 22, MDGL announced a $500 million senior secured credit facility with Blue Owl Capital Inc. (NYSE:OWL), including a $350 million initial term loan and a $150 million delayed draw option through 2027. A doctor wearing a lab coat in a research laboratory, holding up a flask of a potential biotechnology therapeutic solution. The non-dilutive funding will refinance $115 million in existing debt and support strategic growth, with potential for an additional $250 million. Madrigal maintains a strong current ratio of 5.91, signaling solid liquidity. The capital will primarily advance Madrigal's pipeline for metabolic dysfunction-associated steatohepatitis (MASH), led by its FDA-approved drug Rezdiffra—the first treatment for MASH with moderate to advanced fibrosis. A Phase 3 trial is underway to evaluate Rezdiffra for compensated MASH cirrhosis. With strong launch momentum and a patent expected to extend protection through 2044, Madrigal is positioned to lead in MASH therapeutics. Madrigal Pharmaceuticals (NASDAQ:MDGL) is a biotech company that develops and commercializes novel therapies for metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH). While we acknowledge the potential of MDGL as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: and Goldman Sachs REIT Stocks: Top 12 Stock Picks. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Reuters
20-06-2025
- Health
- Reuters
EU medicines regulator grants conditional authorisation for Madrigal's liver disease drug
June 20 (Reuters) - The European Union's medicines regulator on Friday granted a conditional authorisation for Madrigal Pharmaceuticals' (MDGL.O), opens new tab drug for a type of fatty liver disease, paving the way to make it the first treatment available for the condition in the region. The drug, sold as Rezdiffra, was first approved in the United States in March last year. The disease known as non-alcoholic steatohepatitis (NASH), or more recently renamed as metabolic dysfunction-associated steatohepatitis (MASH), causes excess build up of fat in the liver, resulting in inflammation and fibrosis, or scarring, of the organ.
