Shares of Madrigal Pharmaceuticals Surge as Fresh Biennial Data Highlights Possible Advantages of Rezdiffra in Treating Compensated Fatty Liver Cirrhosis

Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) revealed the two-year outcomes from the Phase 3 MAESTRO-NAFLD-1 analysis of Rezdiffra (resmetirom) in patients with compensated MASH cirrhosis on Wednesday. The data indicates significant reductions in liver stiffness, an indicator for fibrosis, among patients on the medication, as confirmed by vibration-controlled transient elastography (VCTE).

101 patients were available for evaluation after two years of treatment. There was a significant average reduction of 6.7 kPa in liver stiffness compared to the baseline measurement of 25 kPa.

The company reports that over half of the patients observed a ≥25% improvement in liver stiffness. Such significant improvements are associated with a reduced risk of advancing to end-stage liver disease.

Rezdiffra, designed to be used alongside diet and exercise, treats adults with noncirrhotic MASH with moderate to severe liver fibrosis. Its ongoing approval may hinge on the verification and description of clinical benefits in continued confirmatory trials. However, its use for MASH cirrhosis remains unapproved.

Alongside these results, Madrigal also announced its fourth-quarter earnings, reporting a loss of $2.71 per share, which is an improvement from a $5.68 loss per share in the prior year, surpassing the anticipated loss of $4.16 per share. Sales reached $103.22 million, exceeding the projected $98.56 million.

“Recalling 2024, we accomplished great things. We achieved FDA approval for Rezdiffra, our pioneer MASH drug, in March; executed an unprecedented disease launch with outstanding outcomes; and are primed for robust performance in 2025 and beyond,” says Bill Sibold, CEO of Madrigal.

Share prices for MDGL saw a 20.30% increase to $372.26 on Wednesday.