Madrigal posts first profitable quarter as Rezdiffra tops $1 billion in 2026 sales

Madrigal Pharmaceuticals said on Nov. 3, 2026 that it will start a second Phase 3 outcomes study, called MAESTRO-CSPH, targeting well-compensated MASH cirrhosis, or F4c. The company said the trial is expected to enroll more than 2,000 F4c patients, with a population significantly enriched for clinically significant portal hypertension, and initiation is expected in the first half of 2027, subject to regulatory discussions.¹ The study is designed, according to Madrigal, to generate the broadest dataset in F4c and support validation of noninvasive biomarkers for Rezdiffra and future pipeline programs.¹

The company's existing Phase 3 program in the same disease stage remains on track. The MAESTRO-NASH OUTCOMES trial is on track, with data expected late 2027.¹

On the commercial side, third-quarter 2026 net sales of Rezdiffra (resmetirom) reached $431.3 million, up 50% year over year, and the quarter marked the company's first quarter of profitability.¹ Year-to-date net sales hit $1.1 billion, putting Rezdiffra past the blockbuster threshold.¹ More than 55,850 patients were on Rezdiffra as of Sept. 30, 2026, nearly double the total from the third quarter of 2025.¹

Madrigal also pointed to market expansion, saying the U.S. F2-F3 MASH addressable population grew to more than 530,000 patients through June 30, 2026, and is on track for more than 30% growth by year-end 2026.¹

On the balance sheet, Madrigal reported cash, cash equivalents, restricted cash and marketable securities of $961.8 million as of Sept. 30, 2026, compared with $988.6 million at the end of 2025.¹

Separately, Dr. John C. Reed, who serves as Executive Vice President, Innovative Medicine, Research & Development at Johnson & Johnson, was appointed to Madrigal's Board of Directors in August.¹