Madrigal Pharmaceuticals is making strides in the treatment of nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) with its drug Rezdiffra (resmetirom). The company's Q3 2024 financial results and corporate updates highlight a successful U.S. launch of Rezdiffra and significant progress in clinical development.
Rezdiffra Launch and Market Access
The U.S. launch of Rezdiffra is progressing well, driven by strong adoption among prescribers and broad payer coverage. As of September 30, over 80% of commercial lives in the U.S. were covered for Rezdiffra, surpassing the company's initial coverage goals ahead of schedule. Notably, less than 5% of covered lives require a biopsy for diagnosis, aligning with current standards of care that favor non-invasive tests (NITs).
Bill Sibold, Chief Executive Officer of Madrigal, stated, “Our U.S. launch of Rezdiffra is progressing exceptionally well driven by the outstanding execution of our team. Growing adoption by prescribers, broader payer coverage and an increasing number of patients on therapy each contributed to the strong performance. This early success highlights the critical need for effective treatments for moderate to advanced NASH/MASH, which is expected to become the leading cause of liver transplants in the U.S.”
Clinical Development and MAESTRO-NASH Outcomes Trial
Madrigal has completed enrollment in the MAESTRO-NASH OUTCOMES trial, which evaluates Rezdiffra in patients with compensated NASH cirrhosis. Positive results from this study could lead to full approval of Rezdiffra and broaden its indication to include patients with compensated cirrhosis. This is a significant milestone, as it could make Rezdiffra the first approved medicine for this patient population.
Sibold continued, “We’ve also advanced our pipeline, completing enrollment in our clinical outcomes study for patients with compensated NASH/MASH cirrhosis. This milestone is key, as positive results could lead to full approval and a broader indication for Rezdiffra.”
Financial Performance
Madrigal reported net revenues of $62.2 million for Q3 2024, reflecting the initial sales of Rezdiffra. The company's operating expenses were $178.5 million, compared to $98.5 million in the same period last year. As of September 30, Madrigal had $1.0 billion in cash, cash equivalents, restricted cash, and marketable securities.
European Expansion
Rezdiffra is currently under evaluation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Madrigal anticipates a decision from the EMA in mid-2025 and plans to directly commercialize resmetirom in Europe if approved.
About NASH/MASH
NASH, now also known as MASH, is a severe form of nonalcoholic fatty liver disease (NAFLD) and is expected to become the leading cause of liver transplants in the U.S. Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., with approximately 525,000 having moderate to advanced liver fibrosis.
