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, Inc. (NASDAQ:MDGL) announced on April 18, 2023, that the FDA granted Breakthrough Therapy designation for its drug resmetirom, aimed at treating nonalcoholic steatohepatitis (NASH) with liver fibrosis. The company also revealed that the Phase 3 MAESTRO-NASH trial has completed enrollment, targeting approximately 1,750 patients. CEO Paul Friedman indicated that the designation reflects the FDA's acknowledgment of resmetirom's potential as a significant therapeutic option for NASH. The company expects to file a New Drug Application (NDA) for resmetirom in Q2 2023 based on positive liver fibrosis outcomes from the ongoing trials. Madrigal is committed to demonstrating resmetirom's efficacy through multiple Phase 3 studies, including MAESTRO-NASH-OUTCOMES, which is vital for regulatory approval.
Madrigal Pharmaceuticals (NASDAQ:MDGL) reported robust financial results for 2022, highlighting a year-end cash position of $358.8 million, up from $270.3 million in 2021. The company is advancing regulatory preparations for resmetirom, following positive Phase 3 MAESTRO-NASH study results, which demonstrated both NASH resolution and fibrosis improvement. These results support a New Drug Application (NDA) filing projected for the first half of 2023. Operating expenses rose to $293.6 million for the year, attributed to increased clinical trial activities and commercial preparations.
Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a clinical-stage biopharmaceutical firm, targets therapies for nonalcoholic steatohepatitis (NASH). The company's management will present at three key investor conferences: the SVB Securities Global Biopharma Conference on February 14, Cowen Annual Healthcare Conference on March 6, and the Oppenheimer Annual Healthcare Conference on March 13, 2023. Each presentation will be available via webcast, and recordings will be archived on Madrigal’s website. Madrigal’s lead candidate, resmetirom, is designed to address significant unmet needs in NASH.
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