CONSHOHOCKEN, Pa. - Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) has announced the availability of Rezdiffra (resmetirom) in the U.S., a novel treatment for nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). This comes after the drug received accelerated approval from the FDA and is the first of its kind to be sanctioned for use in adults with noncirrhotic NASH with moderate to advanced liver fibrosis, equivalent to stages F2 to F3 fibrosis.
Rezdiffra is a once-daily oral medication that functions as a THR-β agonist targeting the underlying causes of NASH. The drug's approval was based on the Phase 3 MAESTRO-NASH trial results, published in February 2024. However, continued approval may depend on the outcomes of ongoing confirmatory trials.
The first patients have begun treatment with Rezdiffra through Madrigal's specialty pharmacy network, marking a significant milestone for those affected by this long-neglected disease. The Global Liver Institute's CEO, Donna R. Cryer, JD (NASDAQ:JD), highlighted the significance of the drug's patient-centric approach, which does not require a biopsy for diagnosis, potentially increasing patient awareness of noninvasive testing options for NASH.
Madrigal's CEO, Bill Sibold, emphasized the importance of the drug's introduction and the company's efforts to establish new care pathways for patient access to Rezdiffra. The recommended dosage of Rezdiffra varies based on body weight, and it is not advised for patients with decompensated cirrhosis. Common side effects include diarrhea, nausea, and pruritis, among others.
NASH is a leading cause of liver-related mortality and is rapidly becoming the primary reason for liver transplantation in the U.S. It is associated with increased morbidity and mortality, especially in patients with advanced metabolic risk factors. Madrigal estimates that about 1.5 million patients have been diagnosed with NASH in the U.S., with approximately 525,000 having moderate to advanced liver fibrosis.
The information in this article is based on a press release statement from Madrigal Pharmaceuticals, Inc.
InvestingPro Insights
As Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) launches Rezdiffra, its novel treatment for NASH, the financial health and market performance of the company become crucial considerations for investors. With a market capitalization of $5.22 billion, Madrigal's financial standing is robust, yet it is important to note the company's current Price to Earnings (P/E) ratio stands at -12.39, reflecting its lack of profitability in the recent period. The adjusted P/E ratio for the last twelve months as of Q4 2023 further dips to -13.97, underlining the challenges the company faces in turning a profit.
InvestingPro Tips indicate that Madrigal holds more cash than debt on its balance sheet, which is a positive sign of financial stability, particularly as it embarks on the commercialization of Rezdiffra. However, analysts have revised their earnings downwards for the upcoming period, and the company is not expected to be profitable this year. Additionally, Madrigal's stock price often moves in the opposite direction of the market, which could be a concern for investors looking for market-correlated growth.
Investors might also be interested in the significant price uptick over the last six months, with a 77.57% return, suggesting a strong market confidence in the potential of Rezdiffra despite the broader financial metrics. With such dynamic movements, those interested in a deeper analysis can explore additional InvestingPro Tips, with PRONEWS24 offering an extra 10% off a yearly or biyearly Pro and Pro+ subscription, to gain more insights into Madrigal's market position and future prospects.
For a comprehensive understanding of Madrigal's financial health and market performance, visit https://www.investing.com/pro/MDGL, where a total of 12 InvestingPro Tips are available, providing investors with a detailed analysis to inform their investment decisions.
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