Madrigal's MASH Drug Rezdiffra Continues Strong Market Performance, Faces Potential Competition

Madrigal Pharmaceuticals' groundbreaking medication for metabolic dysfunction-associated steatohepatitis (MASH), Rezdiffra, has once again exceeded sales expectations in the first quarter of 2025. The drug, which received historic FDA approval in March 2024 as the first treatment for MASH, has consistently outperformed Wall Street projections for four consecutive quarters.

Record-Breaking Sales and Patient Adoption

Rezdiffra generated $137.3 million in sales during Q1 2025, significantly surpassing analysts' average expectation of $112 million. This marks a substantial increase from the previous quarter's $103 million, bringing the total sales for the first 12 months on the market to $317 million.

The drug's rapid adoption is evident in the growing patient base. As of the end of March 2025, more than 17,000 MASH patients were actively taking Rezdiffra, up from 11,800 at the end of 2024. Madrigal CEO Bill Sibold emphasized the exceptional nature of the launch, noting that the rate of new patient additions matches that of other top-tier specialty drug launches.

Market Penetration and Future Growth

Despite its strong performance, Rezdiffra has only penetrated about 5% of Madrigal's target population of 315,000 patients. The company is focusing on patients who fall under Rezdiffra's FDA-approved label and are currently treated by targeted prescribers. Among the 6,000 top MASH prescribers targeted by Madrigal, 70% have already prescribed Rezdiffra.

The drug's success has alleviated initial investor concerns about potential restrictions, such as the requirement for liver biopsies. According to a key opinion leader in the MASH field, payers have not been requiring liver biopsies before granting access to Rezdiffra. Additionally, the expert reported a 90% patient retention rate after one year of treatment.

Potential Competition and Market Expansion

While Rezdiffra currently dominates the MASH treatment landscape, competition may be on the horizon. Novo Nordisk's GLP-1 drug semaglutide, already approved for diabetes and obesity under the brand names Ozempic and Wegovy, has shown positive Phase 3 results in MASH treatment. The FDA has accepted Novo Nordisk's application to expand semaglutide's approval to include MASH treatment.

Madrigal, however, remains optimistic about Rezdiffra's future growth. The company is pursuing geographic expansion, expecting regulatory opinion from the European Medicines Agency and subsequent EU market authorization in mid-2025, with plans to launch first in Germany in the second half of the year.

Furthermore, Madrigal is aiming to expand Rezdiffra's indications to include F4 cirrhotic MASH patients, potentially doubling the drug's market opportunity. The company will present detailed two-year data from the compensated MASH cirrhosis arm of the phase 3 Maestro-NAFLD-1 trial at the upcoming European Association for the Study of the Liver Congress.