CONSHOHOCKEN, PA — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) has announced its financial results for 2024, marking a pivotal year highlighted by the FDA approval and successful launch of Rezdiffra (resmetirom). Rezdiffra, the first and only approved therapy for MASH (metabolic dysfunction-associated steatohepatitis), generated net sales of $103.3 million in the fourth quarter and $180.1 million for the full year. By year-end, more than 11,800 patients were on Rezdiffra therapy.
“Looking back on 2024, I’m incredibly proud of what we accomplished,” said Bill Sibold, CEO of Madrigal. “We secured FDA approval for Rezdiffra in March, executed a first-in-disease product launch, and are well-positioned for sustained growth in 2025 and beyond.”
During 2024, Madrigal achieved several milestones. These included the publication of Rezdiffra’s Phase 3 results in The New England Journal of Medicine, earning recognition as one of the journal’s notable articles of the year. Expert guidelines from both the European Association for the Study of the Liver (EASL) and the American Association for the Study of Liver Diseases (AASLD) recommended Rezdiffra as a first-line therapy for MASH.
The company also announced new two-year data from the MAESTRO-NAFLD-1 Phase 3 trial, detailing significant reductions in liver stiffness among patients with compensated MASH cirrhosis (F4c). Patients achieved a mean reduction of 6.7 kPa in liver stiffness (as measured by vibration-controlled transient elastography), the largest improvement reported in this population. Additionally, 51% of patients experienced a ≥25% reduction in stiffness, an outcome linked to reduced progression to end-stage liver disease.
“These results add to the growing body of evidence supporting Rezdiffra’s potential benefit in high-risk MASH patients,” added Sibold. “A positive readout from our MAESTRO-NASH OUTCOMES trial could further establish Rezdiffra as the only treatment for F2-F4c MASH with outcomes data this decade.”
Looking ahead, Madrigal is preparing for European expansion, with a marketing authorization application under review by the European Medicines Agency. Pending approval, the company expects a phased European launch of Rezdiffra beginning in the second half of 2025.
With $931.3 million in cash and equivalents at year-end and focused R&D efforts, Madrigal remains committed to advancing care for MASH patients, a population facing substantial unmet medical needs.
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