Madrigal Presents Rezdiffra Phase 3 and Real-World Data at EASL 2026 Across Eight Abstracts

Eight abstracts covering cardiovascular risk reduction, portal hypertension stratification, and early real-world effectiveness position Madrigal Pharmaceuticals to broaden the evidence base for Rezdiffra (resmetirom) at a moment when the MASH therapeutic landscape is becoming increasingly competitive. The presentations, scheduled for the EASL Congress 2026 in Barcelona (May 27–30), draw on secondary analyses from the Phase 3 MAESTRO-NASH and MAESTRO-NAFLD-1 trials alongside emerging clinical practice data.

For regulatory affairs leads tracking label evolution, the cardiovascular signal warrants close attention. A secondary analysis examines improvements in Lp(a), LDL-C, and ApoB in patients with MASH independent of baseline lipid status, a finding that, if replicated in prospective data, could support supplemental indication discussions with regulators. A separate analysis of two-year data in compensated MASH cirrhosis (F4c) evaluates ANTICIPATE-NASH risk scores as a predictor of clinically significant portal hypertension, extending the drug's evidence profile into a higher-acuity patient segment.

The noninvasive biomarker work carries direct implications for clinical operations and trial design. Analyses led by Rohit Loomba examine whether early responses in MRI-PDFF, ALT, MRE, and PRO-C3 predict histological improvement in MASH and liver fibrosis, a question central to reducing biopsy burden in future studies. A parallel machine-learning model, also drawing on MAESTRO-NAFLD-1 and MAESTRO-NASH biopsy data, attempts to predict fibrosis stage from noninvasive tests alone. If validated, such models could reshape patient selection criteria and inform eligibility thresholds for real-world prescribing.

Real-world evidence presentations add a post-approval dimension. Two abstracts report early effectiveness data from adults with moderate-to-advanced fibrosis in routine clinical settings, alongside twelve-month changes in liver enzymes and lipids. A registry-based analysis from the German SLD-Registry models patient eligibility using noninvasive test data, providing an external-population check on trial-derived thresholds. Rezdiffra received approval in both the U.S. and Europe as the first pharmacological treatment for MASH, with the pivotal MAESTRO-NASH trial demonstrating achievement of both fibrosis improvement and MASH resolution co-primary endpoints.

The cumulative dataset being assembled across these eight abstracts will likely inform Madrigal's regulatory strategy for potential label updates, while the noninvasive biomarker validation work sets a measurable benchmark for how treatment response is monitored outside of biopsy-confirmed trial settings.

Source: Madrigal Pharmaceuticals via GlobeNewswire, May 20, 2026.