Based in West Conshohocken, PA, Madrigal Pharmaceuticals, Inc. is a commercial-stage company focused on developing novel therapeutics for patients with NASH. This serious liver disease can lead to cirrhosis, liver failure and premature mortality. NASH is also known as metabolic dysfunction-associated steatohepatitis (MASH).

In March 2024, Madrigal’s lead candidate, Rezdiffra (resmetirom), became the first and only FDA-approved therapy for the treatment of adult patients with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), in conjunction with diet and exercise. The drug was approved under the FDA’s accelerated pathway and was commercially launched in the United States in April 2024. Rezdiffra is a once-daily, oral and liver-directed THR-β agonist designed to target key underlying causes of NASH.

A regulatory application seeking the approval of resmetirom for the same indication is also currently under review in the EU. A final decision is expected in mid-2025.

The company’s clinical-stage pipeline currently comprises several late-stage studies evaluating expanded use of Rezdiffra for NASH, including the pivotal MAESTRO-NASH biopsy study in patients with significant fibrosis, the MAESTRO-NASH Outcomes study in patients with NASH with compensated cirrhosis and the MAESTRO-NAFLD-1 open-label extension (OLE) safety study.

In the absence of ongoing collaboration agreements, Madrigal’s only contributor to the top line is Rezdiffra sales. The company recorded $14.6 million in revenues in the second quarter of 2024, driven by early patient demand for the drug. Continued approval of the drug will depend on the success of the confirmatory studies.

Madrigal did not recognize any revenues in 2023 or the year before.