Former Employee Complaint Shadows Madrigal as Rezdiffra Revenue Reaches $431.3 Million
Key Facts
Madrigal Pharmaceuticals disclosed in its quarterly report a complaint filed by a former employee on October 9, 2026, in federal court in Illinois, alleging the company retaliated against him under the whistleblower protection provisions of the Sarbanes-Oxley Act. The action is separate from an investigation by law firm Hagens Berman, which could not be verified through a credible open source. The company said the complaint concerns internal concerns the employee raised about some of its data and reporting practices. It said those concerns predated his resignation in January 2026. The plaintiff is seeking monetary damages and other relief, while the company disputes the allegations and says it intends to defend itself.
The complaint comes as Rezdiffra serves as the company's main commercial driver, posting net sales of $431.3 million in the third quarter of 2026, up 50% year over year from the same period a year earlier. The drug generated $1.1 billion in sales from the start of 2026 through the end of the third quarter, according to the earnings statement Madrigal filed with the Securities and Exchange Commission. The company attributed revenue growth to increased demand for the treatment in the United States. Madrigal posted net income of $55.4 million in the third quarter, after recording a net loss of $114.2 million in the corresponding period of 2025. The results make the complaint relevant to investors in a company that relies on one product, but its disclosure does not resolve the allegations or their effect on the business.
As of September 30, 2026, more than 55,850 patients were receiving Rezdiffra, according to the company. Madrigal estimated the U.S. population of patients with metabolic dysfunction-associated steatohepatitis, in fibrosis stages F2-F3, at more than 530,000 as of June 30, 2026. On November 5, the company said real-world studies presented at the AASLD meeting showed improved or stable liver stiffness in up to 93% of patients after about a year of treatment. These are results Madrigal reported from real-world studies and do not represent an independent judgment on the allegations in the complaint. Efficacy and safety data remain a focus for investors as use of the drug expands.
The U.S. Food and Drug Administration approved Rezdiffra, whose generic name is resmetirom, on March 14, 2024, to treat adults with nonalcoholic steatohepatitis and moderate to advanced liver scarring, without cirrhosis, alongside diet and exercise. The safety and efficacy assessment was based on a surrogate endpoint measured at month 12 in a 54-month, randomized, double-blind, placebo-controlled trial. The study is continuing to verify the treatment's clinical benefit. In biopsy results at month 12, rates of steatohepatitis resolution without worsening fibrosis ranged from 26% to 27% for the 80 mg dose, depending on the two pathologists' readings, and from 24% to 36% for the 100 mg dose. The placebo group recorded rates ranging from 9% to 13% across the two readings.
The Food and Drug Administration requires completion of the MGL-3196-11 trial, a 54-month placebo-controlled study, to verify clinical benefit on a composite of outcomes that includes progression to cirrhosis, worsening liver function, liver transplantation and death. The listed trial completion date is March 31, 2029. Madrigal also expects confirmatory MAESTRO-NASH results in 2028 and data from the MAESTRO-NASH OUTCOMES study in late 2027. The company said positive results could support full approval of Rezdiffra. The company's shares closed at $432.79 on November 9, 2026, according to EL7 data.