CONSHOHOCKEN, Pa. - Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) has announced new data from the Phase 3 MAESTRO-NASH trial, indicating that its drug Rezdiffra may improve fibrosis and other health outcomes in patients with nonalcoholic steatohepatitis (NASH). The findings were presented at the EASL Congress held from June 5-8, 2024, in Milan, Italy.
Rezdiffra is a once-daily oral medication and the first approved treatment for NASH, a liver disease that can progress to cirrhosis. The trial results suggest that Rezdiffra, in conjunction with diet and exercise, could benefit adults with noncirrhotic NASH with moderate to advanced liver fibrosis.
In the MAESTRO-NASH trial, Rezdiffra met both primary endpoints of fibrosis improvement and NASH resolution. Moreover, 80% of patients treated with Rezdiffra 100 mg experienced improvement or stabilization of fibrosis. The trial's findings are particularly noteworthy as they include an innovative AI-based analysis of biopsy data, which showed significant improvement in fibrosis with Rezdiffra treatment compared to placebo.
The study also revealed that after three years of treatment, 91% of patients had improved or stable liver stiffness, a measure of fibrosis. Additionally, the first analysis of health-related quality of life data from the trial demonstrated that Rezdiffra improved patient worry, health distress, and stigma.
Furthermore, the first analysis of Rezdiffra treatment in patients with metabolic dysfunction and alcohol-associated liver disease (MetALD) showed similar rates of fibrosis improvement and steatohepatitis resolution compared to the NASH population.
Madrigal's CEO, Bill Sibold, commented on the broader implications of the data, highlighting Rezdiffra's potential as a foundational therapy in NASH treatment. The company's ongoing Phase 3 outcomes studies are expected to further confirm Rezdiffra's clinical benefits.
The MAESTRO-NASH trial is ongoing, with patients continuing on therapy for up to 54 months to measure hepatic clinical outcome events. The results of the trial, which enrolled 1759 patients with biopsy-confirmed NASH, have been published in the New England Journal of Medicine in February 2024.
NASH, recently renamed as metabolic dysfunction associated steatohepatitis (MASH), is a leading cause of liver-related mortality and is becoming the primary reason for liver transplantation in the U.S. Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., with around 525,000 having moderate to advanced liver fibrosis.
Madrigal's robust cash position of $1.1 billion is expected to fully fund the Rezdiffra launch. The company's peak sales are estimated to reach approximately $6.8 billion in the U.S., reflecting the significant market potential of Rezdiffra. However, the high cost of Rezdiffra, $47,000 per patient-year, could present commercial challenges.
Madrigal has recently announced the availability of Rezdiffra in the U.S., marking a significant milestone for those affected by NASH. The company aims to have 80% of commercial lives covered by the end of 2024, with full Medicare coverage expected in early 2025. These are the recent developments in the company's journey.
InvestingPro Insights
As Madrigal Pharmaceuticals (NASDAQ:MDGL) makes strides with its groundbreaking NASH treatment, Rezdiffra, the company's financial health and market performance offer additional insights. With a market capitalization of $5.03 billion, Madrigal showcases its potential in the biopharmaceutical sector. However, investors should note that the company's Price/Earnings (P/E) ratio stands at -9.96, reflecting expectations of future growth rather than current profitability. This is further emphasized by an adjusted P/E ratio for the last twelve months as of Q1 2024 at -11.32, suggesting a widening gap between share price and earnings.
Madrigal's financial stability is highlighted by an InvestingPro Tip stating the company holds more cash than debt on its balance sheet, which could provide resilience and flexibility in funding ongoing clinical trials and potential commercialization efforts. On the flip side, another InvestingPro Tip indicates that analysts have revised their earnings downwards for the upcoming period, hinting at potential challenges ahead.
Investors eyeing Madrigal's long-term prospects should consider the company's Price/Book ratio of 5.91, which might suggest a premium valuation compared to its book value. Moreover, the company's stock has experienced a 1-year price total return of -13.83%, reflecting the volatility and risk inherent in the biotech industry.
For those interested in deeper analysis, InvestingPro offers additional insights, including 11 more InvestingPro Tips that can help evaluate Madrigal's future prospects. To access these insights and more, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at: https://www.investing.com/pro/MDGL.
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