Madrigal Pharmaceuticals Stock Jumps On New Two-Year Data Showing Potential Benefit of Rezdiffra For Compensated Fatty Liver Cirrhosis

On Wednesday, Madrigal Pharmaceuticals, Inc. MDGL reported two-year results from the open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra (resmetirom).

Patients treated with Rezdiffra achieved marked reductions in liver stiffness, a surrogate for fibrosis, measured by vibration-controlled transient elastography (VCTE).

The Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra included an open-label active treatment arm of patients with compensated MASH cirrhosis. Madrigal previously reported one-year results from this cohort.

Following two years of treatment, 101 patients had VCTE results for analysis.

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The mean liver stiffness at baseline was 25 kPa. Patients achieved a mean 6.7 kPa reduction in liver stiffness at two years (6.1 kPa at one year), which was statistically significant compared to baseline.

In a responder analysis examining ≥25% improvement or worsening of liver stiffness, 51% of patients achieved improvement. The company says improvement of this magnitude has been associated with reduced progression to end-stage liver disease.

Draft FDA guidance recommends that Phase 3 clinical trials in MASH cirrhosis use outcomes as an endpoint instead of biopsy-based surrogate endpoints.

Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).

Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.

Rezdiffra is not approved for the treatment of patients with MASH cirrhosis.

Concurrently, Madrigal Pharmaceuticals reported a fourth-quarter loss of $2.71 per share, down from a loss of $5.68 a year ago, beating the consensus loss of $4.16 per share.

The company reported sales of $103.22 million, beating the consensus of $98.56 million.

Bill Sibold, Chief Executive Officer of Madrigal, stated, "Looking back on 2024, I'm incredibly proud of what we accomplished. We secured FDA approval for Rezdiffra, the first medicine approved for MASH, in March; executed a first-in-disease launch with remarkable results; and are well positioned for strong performance again in 2025 and beyond."

Price Action: MDGL stock is up 20.30% at $372.26 at the last check on Wednesday.

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