Welcome to our dedicated page for Madrigal Pharmaceuticals news (Ticker: MDGL), a resource for investors and traders seeking the latest updates and insights on Madrigal Pharmaceuticals stock.
Madrigal Pharmaceuticals, Inc. develops and commercializes therapies for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease that can progress to cirrhosis and liver failure. Its principal medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed thyroid hormone receptor beta agonist approved by the FDA and European Commission for MASH with moderate to advanced fibrosis.
Company news regularly covers Rezdiffra sales and patient adoption, quarterly financial results, regulatory and clinical development updates, and pipeline expansion through licensed assets such as ARO-PNPLA3, a clinical-stage siRNA program targeting PNPLA3, and an oral GLP-1 receptor agonist program. Madrigal also issues recurring corporate-governance updates, including Nasdaq inducement awards under its employee equity plans.
Madrigal Pharmaceuticals (NASDAQ:MDGL) has received a Notice of Allowance from the USPTO for a new patent covering Rezdiffra™ (resmetirom), their FDA-approved treatment for adults with noncirrhotic MASH with moderate to advanced liver fibrosis.
The patent, which will be listed in the FDA's Orange Book, provides protection through September 30, 2044. It specifically covers Rezdiffra's commercial weight-threshold dosing regimen as prescribed in the FDA-approved label. This development strengthens Madrigal's market position as the provider of the first and only FDA-approved treatment for MASH (also known as NASH).
Among patients with clinically significant portal hypertension (CSPH) at baseline, 65% moved to lower risk categories by year two. The study showed a statistically significant mean reduction of 6.7 kPa in liver stiffness, with 51% of patients achieving ≥25% improvement.
Notable outcomes include 35% of patients achieving liver stiffness measurements consistent with F3 fibrosis, suggesting cirrhosis reversal. The drug was well-tolerated, with common side effects including diarrhea, COVID-19, and nausea. The results support the ongoing Phase 3 MAESTRO-NASH OUTCOMES trial of Rezdiffra in compensated MASH cirrhosis.
Madrigal Pharmaceuticals announced six presentations at the upcoming EASL Congress in Amsterdam (May 7-10, 2025), featuring crucial data about their drug resmetirom for MASH treatment. The highlight is a late-breaking presentation on two-year data from patients with compensated MASH cirrhosis.
Resmetirom, the first FDA-approved medication for MASH in the US, is a daily oral liver-directed THR-β agonist. The drug showed promising results in the Phase 3 MAESTRO-NASH trial, with 91% of patients on 100mg dosage experiencing liver stiffness improvement or stabilization.
Currently under review by European regulators, Madrigal expects a CHMP opinion and EU decision by mid-2025, with potential launches starting in Germany in late 2025. The company will host an investor webcast on May 13, 2025, to review detailed two-year data from the compensated MASH cirrhosis study.
Madrigal Pharmaceuticals (NASDAQ: MDGL), a biopharmaceutical company specializing in novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), has scheduled its first-quarter 2025 financial results release for Thursday, May 1, 2025, before U.S. markets open.
The company will host a live webcast at 8 a.m. Eastern Time where management will review financial and operating results. Participants are advised to register 15 minutes before the scheduled webcast, which will be accessible through the Investor Relations section of Madrigal's website. A replay will be available approximately two hours after the live event.
Madrigal Pharmaceuticals (NASDAQ: MDGL) announced key leadership changes as company founder Rebecca Taub, M.D., transitions from Chief Medical Officer and President of R&D to Senior Scientific and Medical Advisor, while maintaining her position on the Board of Directors. David Soergel, M.D., has been appointed as the new Executive Vice President and Chief Medical Officer, effective April 21, 2025.
Dr. Taub's legacy includes pioneering the development of Rezdiffra™ (resmetirom), the first FDA-approved medicine for treating metabolic dysfunction-associated steatohepatitis (MASH). Under her leadership, Madrigal grew from a small R&D team of fewer than 10 professionals to a commercial-stage biopharma company with over 500 employees across the U.S. and Europe.
Dr. Soergel joins from Novartis, where he served as Executive Vice President and Global Head of Cardiovascular, Renal, and Metabolism Development, overseeing 10 late-stage development programs in 2024. The company currently has two fully enrolled outcomes studies of Rezdiffra underway.
Madrigal Pharmaceuticals (NASDAQ:MDGL) has appointed Jacqualyn "Jackie" Fouse, Ph.D. to its Board of Directors, while Fred Craves, Ph.D. will retire from the Board in July 2025. Fouse brings over 30 years of healthcare industry and finance experience, having previously served as CEO of Agios Pharmaceuticals and held executive positions at Celgene , Bunge , and Alcon Laboratories.
The appointment aligns with Madrigal's strategic focus on metabolic dysfunction-associated steatohepatitis (MASH). The company aims to drive the launch of Rezdiffra, their first approved MASH treatment, expand geographically, advance their clinical program in compensated MASH cirrhosis, and build their pipeline.