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. (NASDAQ: MDGL) is a clinical-stage biopharmaceutical company based in Madrid, Spain, with a focus on developing and commercializing innovative therapies for cardiovascular-metabolic diseases and non-alcoholic steatohepatitis (NASH). Madrigal's headquarters are located at Calle Laguna del Marquesado Nª 19, Nave 16 Edificio Adriana 1ª Planta, Polígono Industrial La Resina (Villaverde), Madrid.
Madrigal's lead product candidate is MGL-3196, also known as Rezdiffra (resmetirom), an orally administered, small-molecule, liver-directed, B-selective THR-β agonist. Rezdiffra is designed to target the key underlying causes of NASH and has shown significant potential in reducing liver fibrosis and resolving NASH. Rezdiffra also reduces plasma and liver triglycerides by increasing fat metabolism and displays anti-diabetic effects.
On March 14, 2024, Madrigal announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Rezdiffra for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (stages F2 to F3). The approval was based on the results of the Phase 3 MAESTRO-NASH trial, which demonstrated that Rezdiffra significantly improved both NASH resolution and fibrosis.
Rezdiffra's accelerated approval marks a pivotal moment in the treatment of NASH, a progressive liver disease that has previously had no FDA-approved therapies. Rezdiffra is now available in the U.S. and is expected to become the foundational therapy for NASH, reflecting Madrigal's commitment to addressing this high unmet medical need.
In an effort to support patients, Madrigal has established the Madrigal Patient Support Program, which aims to assist patients in navigating insurance and affordability challenges. This program also offers co-pay support for eligible patients and provides access to medication through a limited specialty pharmacy network.
In addition to NASH, Madrigal continues to explore other therapeutic areas, including familial hypercholesterolemia, with ongoing research and development initiatives. The company is actively involved in expanding its clinical trials to validate the long-term benefits of Rezdiffra and is committed to advancing the science around liver diseases.
As of recent updates, Madrigal has commenced an underwritten public offering to raise $500 million to support the commercial launch of Rezdiffra in the U.S. and other corporate initiatives. The company remains focused on leveraging its innovative therapeutic approach to improve patient outcomes and drive long-term growth.
Madrigal Pharmaceuticals (NASDAQ:MDGL) has appointed Shannon Kelley as General Counsel, effective August 5, 2024. Kelley, who joined Madrigal in 2024 as Chief Compliance Officer, brings over 20 years of healthcare legal and compliance experience. Previously, she held senior roles at Sanofi and Boston Scientific , and worked in enforcement roles with the U.S. Federal Government.
CEO Bill Sibold praised Kelley's leadership and expertise, highlighting her instrumental role in guiding the company through rapid growth. Kelley expressed enthusiasm about Madrigal's opportunity to deliver groundbreaking therapy for nonalcoholic steatohepatitis (NASH), the leading cause of liver transplantation in women in the U.S. She aims to be a strategic partner in building an industry-leading company with a strong culture of ethics and integrity.
Madrigal Pharmaceuticals (Nasdaq: MDGL) has announced the release date for its second-quarter 2024 financial results. The company will disclose the results on Wednesday, August 7, 2024, before the U.S. financial markets open. Following this, Madrigal's management will host a live webcast at 8 a.m. Eastern Time to review the financial and operating results.
Investors and interested parties can access the webcast through the Investor Relations section of Madrigal Pharmaceuticals' website. To ensure a smooth connection, participants are advised to register at least 15 minutes before the scheduled start. The webcast will remain available for approximately two hours after the live event concludes.
Madrigal Pharmaceuticals announced new data from the Phase 3 MAESTRO-NASH study of Rezdiffra™ (resmetirom) at the EASL Congress.
The study showed Rezdiffra improved key fibrotic features predictive of cirrhosis. AI-driven analysis revealed that 80% of patients treated with Rezdiffra experienced fibrosis improvement or stabilization. In noninvasive tests over three years, 91% showed improved or stable liver stiffness.
Health-related quality of life metrics also improved, including reductions in worry, health distress, and stigma. Additionally, Rezdiffra had positive outcomes in patients with Metabolic Dysfunction and Alcohol-Associated Liver Disease (MetALD).
The data supports Rezdiffra as a foundational therapy in NASH, demonstrating durable responses and broad treatment benefits.
Madrigal Pharmaceuticals (Nasdaq: MDGL) will participate in the Goldman Sachs 45th Annual Global Healthcare Conference on June 11, 2024. The company will present at 8:40 A.M. ET, with the presentation webcast live on Madrigal’s Investor Relations Events page. A replay of the webcast will be available post-event. This participation reflects Madrigal's engagement with key industry stakeholders and potential investors.
Madrigal Pharmaceuticals, a biopharma company specializing in NASH treatment, will present ten data abstracts at the EASL Congress from June 5-8, 2024, in Milan.
The presentations will focus on Rezdiffra™ (resmetirom), a novel THR-β agonist and the first approved NASH therapy. Highlights include new Phase 3 MAESTRO data on quality of life, noninvasive test results, and Rezdiffra's efficacy in MetALD patients.
Additionally, Madrigal will showcase real-world data on NASH's human and economic impact, noting faster progression to severe liver conditions than previously thought.
Rezdiffra has shown significant efficacy in improving or stabilizing fibrosis in 80% of patients and is indicated for noncirrhotic NASH with moderate to advanced fibrosis. Continued approval hinges on ongoing confirmatory trials.
Madrigal Pharmaceuticals reported strong financial results for the first quarter of 2024, highlighted by the approval and launch of Rezdiffra™ for the treatment of NASH. The company raised $690 million in gross proceeds from a public offering, with cash, cash equivalents, and marketable securities totaling $1.1 billion as of March 31, 2024. Key corporate updates include the appointment of a new CFO and the validation of the European Medicines Agency marketing application for resmetirom.
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