CONSHOHOCKEN, PA — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) has released a business update highlighting strong preliminary financial results for 2024 and the ongoing success of its breakthrough treatment, Rezdiffra™ (resmetirom), for MASH (metabolic-associated steatohepatitis).
The company reported preliminary Rezdiffra net sales of $100 million to $103 million for the fourth quarter and $177 million to $180 million for the full year. Additionally, Madrigal closed 2024 with approximately $931 million in cash, cash equivalents, and marketable securities and over 11,800 patients on Rezdiffra therapy.
Rezdiffra, approved by the U.S. FDA in March 2024 as the first and only treatment for MASH, has significantly reshaped the treatment landscape for this serious liver disease. MASH is expected to become the leading cause of liver transplants in the United States, underscoring the urgency for effective therapies.
“2024 was a transformational year for Madrigal and the MASH field,” said Bill Sibold, Chief Executive Officer of Madrigal. “Rezdiffra received U.S. FDA approval as the first and only treatment for MASH; we built an expert team for launch; and now more than 11,800 patients are on therapy. Our success reflects exceptional execution and the urgent need for treatments for this serious liver disease.”
The company also achieved notable milestones in 2024, including the publication of Phase 3 MAESTRO-NASH trial results in The New England Journal of Medicine, completion of enrollment in the MAESTRO-NASH OUTCOMES trial, and advancement of its European expansion plans. Madrigal expects the European Medicines Agency (EMA) to decide on Rezdiffra’s marketing application by mid-2025, with plans for country-specific launches starting in the second half of that year.
Looking ahead, Madrigal sees significant growth potential as it targets additional markets and prepares for the outcomes data from the MAESTRO-NASH trial. Positive results could position Rezdiffra as the only therapy for F2 to F4 MASH and the only treatment backed by outcomes data this decade.
“As we build momentum in the U.S., we are pursuing additional growth opportunities, including preparing for European expansion in the second half of 2025,” Sibold added. “The MAESTRO-NASH OUTCOMES trial in compensated cirrhosis could unlock further growth.”
With its strong financial position, innovative therapy, and clear path forward, Madrigal is well-positioned to address the unmet needs of patients and solidify its leadership in the MASH field.
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