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) 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.
Madrigal Pharmaceuticals (NASDAQ:MDGL) announced Dr. Stephen Harrison's presentation on Resmetirom at The Liver Meeting Digital Experience™ on November 13, 2020. The early data from Phase 3 MAESTRO trials demonstrated significant reductions in liver fat and inflammatory biomarkers. At week 16, patients showed a 53% reduction in MRI-PDFF fat levels, with 80% achieving a 30% reduction. Overall, Resmetirom shows promise for treating NASH, with no safety concerns at the 100 mg dose. Ongoing studies will further evaluate its efficacy and safety.
Madrigal Pharmaceuticals (NASDAQ:MDGL) has completed enrollment for its MAESTRO NAFLD-1 clinical trial with over 1,200 patients, expanding from an initial goal of 700 to enhance safety data for its drug, resmetirom. The company reported third quarter 2020 financial results with cash reserves of $335.9 million, down from $439.0 million at the end of 2019, largely due to operational costs of $102.6 million. Operating expenses surged to $58.8 million for the quarter, primarily driven by increased R&D expenses of $53.3 million.
Madrigal Pharmaceuticals (NASDAQ:MDGL) recently announced significant findings from its ongoing Phase 3 MAESTRO studies on resmetirom, aimed at treating NASH patients with fibrosis stages 2-3. Data revealed high accuracy in predicting advanced NASH fibrosis using non-invasive methods. The MAESTRO-NAFLD-1 open-label arm showed robust improvements in liver fat and fibrosis after 16 weeks, with a 53% reduction in hepatic fat. The results suggest resmetirom's potential to enhance quality of life for NASH patients, demonstrated during a presentation at The Liver Meeting on November 13, 2020.
Madrigal Pharmaceuticals (NASDAQ:MDGL) reported significant findings from the ongoing Phase 3 MAESTRO-NASH study, which focuses on advanced NASH fibrosis. Using non-invasive imaging and biomarkers, the study predicts advanced fibrosis (F2-F3) with high accuracy. Data from the open-label MAESTRO-NAFLD-1 trial show a 53% reduction in liver fat at Week 16 of resmetirom treatment. The drug also demonstrated a notable decrease in atherogenic lipid levels. Dr. Stephen Harrison will present these findings at The Liver Meeting on November 13, 2020.
Madrigal Pharmaceuticals (NASDAQ:MDGL) announced that it has surpassed its enrollment target of 700 patients in the MAESTRO NAFLD-1 clinical trial for resmetirom, aimed at treating non-alcoholic steatohepatitis (NASH) with fibrosis. Following the completion of enrollment, topline data is expected by the end of next year. The trial's strong patient participation reflects the high prevalence of NASH. Secondary analyses indicated that a reduction in liver fat correlates with improvements in NASH-related histological responses. Resmetirom is designed as a β-selective thyroid hormone receptor agonist.
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?
