Madrigal Pharmaceuticals disclosed that its Phase 3 MAESTRO‑NAFLD‑1 trial produced encouraging two‑year results in patients with compensated MASH cirrhosis (F4c), a population that currently has no approved therapies. The data were presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting on November 10 2025.
The open‑label F4c cohort comprised 122 patients, of whom 113 completed the full two‑year period. In the high‑risk subgroup of 30 patients with baseline platelet counts below 100,000 /µL, mean liver stiffness fell by 7.9 kPa, compared with a 6.4 kPa reduction in the higher‑platelet group. Two‑thirds of all participants shifted to a lower Baveno risk category for clinically significant portal hypertension, and improvements were also seen in liver enzymes, fibrosis biomarkers (CK‑18, PRO‑C3, adiponectin) and atherogenic lipids. A temporary treatment interruption of roughly 77 days produced a reversible decline in these benefits, underscoring the necessity of continuous therapy.
The findings reinforce Rezdiffra’s clinical value in an unmet‑need segment and support the ongoing Phase 3 MAESTRO‑NASH OUTCOMES trial, which is evaluating the drug’s impact on decompensation events in compensated cirrhosis. If the outcomes confirm the two‑year data, regulatory approval for an expanded F4c indication could double the drug’s addressable market. CEO Bill Sibold emphasized that “approval in the F4c setting is a key pillar of our long‑term strategy and could double the drug’s market opportunity.”
Madrigal’s Q3 2025 earnings, released on November 4, showed net sales of $287.3 million—an increase of more than 400 % from $62.2 million in Q3 2024—driven by strong Rezdiffra uptake. The company reported an EPS miss, largely attributable to a one‑time licensing expense for MGL‑2086 and higher R&D and SG&A costs associated with the drug’s launch. Despite the earnings miss, the company’s guidance for full‑year 2025 revenue remained robust, reflecting confidence in continued patient growth and the momentum generated by the new clinical data.
Investors and analysts reacted positively to the two‑year data, noting that the results address a critical unmet need and could accelerate regulatory approval. The announcement reinforced confidence in Rezdiffra’s commercial trajectory and highlighted the company’s focus on patient adherence and long‑term outcomes.
Madrigal will continue to monitor the MAESTRO‑NASH OUTCOMES trial and will seek regulatory submissions for the expanded indication once the outcomes data mature. The company’s strategy of expanding market penetration while maintaining a focus on adherence positions it to capitalize on the potential approval in the F4c MASH population.
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