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 has appointed Dr. Robert Waltermire as Chief Pharmaceutical Development Officer. With over 30 years of experience in pharmaceutical development, he will lead CMC development for resmetirom, Madrigal's lead candidate for treating NASH. This product is in two Phase 3 clinical studies aimed at addressing significant unmet medical needs. Dr. Waltermire's prior roles include Senior VP at VenatoRx and VP at Bristol-Myers Squibb, underscoring his extensive expertise. The company aims to achieve first-to-market status in the NASH treatment arena, potentially benefiting millions of patients.
Madrigal Pharmaceuticals (NASDAQ: MDGL) has dosed its first patient in the MAESTRO-NAFLD-1 Open Label Extension (NCT04951219), following the completion of the MAESTRO-NAFLD-1 Phase 3 study. This 52-week study evaluates the efficacy of resmetirom in addressing non-alcoholic fatty liver disease (NAFLD), presumed non-alcoholic steatohepatitis (NASH). Patients previously on placebo can now receive active treatment, while those on resmetirom continue. Positive results have been reported from prior trials, strengthening prospects for future treatment success and additional data on safety and efficacy.
Madrigal Pharmaceuticals (NASDAQ: MDGL) announced the achievement of planned target enrollment in its Phase 3 trial, MAESTRO-NASH, aimed at treating NASH with its lead candidate, resmetirom. The company plans to submit for Subpart H (Accelerated Approval) to the FDA, supported by data from MAESTRO-NASH and MAESTRO-NAFLD-1, which collectively involve over 2,000 patients. Topline data is expected by Q3 2022. The studies highlight the significant unmet medical need for NASH therapies.
Madrigal Pharmaceuticals (NASDAQ:MDGL) presented positive clinical data from the Phase 3 MAESTRO-NAFLD-1 study of resmetirom for treating nonalcoholic steatohepatitis (NASH) at the International Liver Congress 2021. Resmetirom, administered at 100 mg daily for 52 weeks, was found to be safe, well-tolerated, and effective in reducing hepatic fat, fibrosis, liver injury, and atherogenic lipids in both non-cirrhotic and well-compensated cirrhotic patients. The study utilized non-invasive assessments to monitor treatment response, suggesting a promising future for resmetirom as a leading therapeutic option for NASH patients.
Madrigal Pharmaceuticals (NASDAQ: MDGL) announced participation in two upcoming virtual investor conferences. The 42nd Annual Goldman Sachs Global Healthcare Conference fireside chat is scheduled for June 10, 2021, at 9:40 a.m. ET, followed by a JMP Securities Life Sciences Conference fireside chat on June 16, 2021, at 3:30 p.m. ET. Both presentations will be webcast live and available for 90 days replay.
Madrigal focuses on developing therapeutics for cardio-metabolic and fatty liver diseases, with its lead candidate, resmetirom, currently in two Phase 3 studies for NASH and NAFLD.
Madrigal Pharmaceuticals (NASDAQ: MDGL) will participate in a fireside chat at the UBS Global Healthcare Virtual Conference on May 24, 2021, at 4:00 pm ET. The executive team, including CEO Paul Friedman, CMO Becky Taub, and CFO Alex Howarth, will discuss the company’s novel therapeutics targeting cardio-metabolic and fatty liver diseases, particularly non-alcoholic steatohepatitis (NASH). The chat will be available for live webcast and replay for 90 days in the Investor Relations section of Madrigal's website.
Madrigal Pharmaceuticals (NASDAQ: MDGL) announced that its executive team will present at the RBC Capital Markets Virtual 2021 Global Healthcare Conference on May 19, 2021, at 8:00 a.m. ET. Key executives include CEO Paul Friedman, CMO Becky Taub, Senior VP Remy Sukhija, and CFO Alex Howarth. The presentation will be accessible via live webcast on Madrigal's Investor Relations page and available for replay for 90 days. Madrigal focuses on developing therapies for cardio-metabolic and fatty liver diseases, with its leading candidate, resmetirom, currently in two Phase 3 trials for NASH and NAFLD.
Madrigal Pharmaceuticals (NASDAQ:MDGL) announced the appointment of Alex Howarth as Chief Financial Officer, effective immediately. Howarth brings over 25 years of biopharmaceutical experience from commercial-stage companies and multinational organizations, including Akcea Therapeutics and GlaxoSmithKline. CEO Paul Friedman emphasized Howarth's role will be critical as Madrigal advances its two Phase 3 studies for resmetirom, a treatment for NASH and NAFLD. The company plans to seek partnerships for Ex-U.S. commercialization as it transitions from development to commercial stage.
Madrigal Pharmaceuticals (NASDAQ:MDGL) reported strong financial results for Q1 2021, showcasing cash and marketable securities of $307.2 million, up from $284.1 million at the end of 2020. This growth was primarily driven by net proceeds of $66.6 million from stock sales. Operating expenses increased to $53.0 million, with R&D expenses reaching $45.8 million due to ongoing Phase 3 clinical trials. The company aims to complete subject enrollment for the MAESTRO-NASH trial by Q2 2021 and release topline data from MAESTRO-NAFLD-1 by year-end, positioning itself as a leader in the NASH market.
Madrigal Pharmaceuticals (NASDAQ:MDGL) reported its financial results for Q4 and full year 2020, highlighting significant progress despite COVID-19 challenges. The company successfully completed enrollment in its Phase 3 MAESTRO-NAFLD-1 trial with over 1,200 patients. Madrigal had cash and marketable securities of $284.1 million as of Dec 31, 2020, down from $439 million in 2019, primarily due to operational cash usage of $157.6 million. R&D expenses surged to $184.8 million, reflecting increased clinical trial activities. Key milestones for 2021 include data releases from ongoing trials.
FAQ
What is the current stock price of Madrigal Pharmaceuticals (MDGL)?
What is the market cap of Madrigal Pharmaceuticals (MDGL)?
What is Madrigal Pharmaceuticals, Inc.?
What is Rezdiffra?
Where is Madrigal Pharmaceuticals headquartered?
What recent FDA approval did Madrigal Pharmaceuticals receive?
What is the Madrigal Patient Support Program?
What are the primary endpoints achieved by Rezdiffra in the Phase 3 MAESTRO-NASH trial?
How does Rezdiffra work?
What is Madrigal's focus for the future?
What was the outcome of the public offering announced by Madrigal?
How can one access more information about Madrigal Pharmaceuticals?
