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 announced its participation in three upcoming investor conferences focused on healthcare. The events include the Jefferies Global Healthcare Conference on June 9, 2022, the Goldman Sachs Annual Global Healthcare Conference on June 14, 2022, and the JMP Securities Life Sciences Conference on June 15, 2022. Presentations will be available via webcast and can be re-watched on the company's website. Madrigal is developing treatments for non-alcoholic steatohepatitis (NASH), with its leading candidate, resmetirom, currently in Phase 3 trials.
Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) announced its participation in two investor conferences on May 24, 2022. The company will host a fireside chat at the H.C. Wainwright Global Life Sciences Conference at 7:00 AM ET, followed by another at the UBS Global Healthcare Conference at 8:30 AM ET. Both presentations will be available via webcast and archived for later replay on the Madrigal website. The company focuses on developing novel therapeutics for non-alcoholic steatohepatitis (NASH), with its lead candidate resmetirom under evaluation in Phase 3 studies.
Madrigal Pharmaceuticals (NASDAQ: MDGL) announced that four abstracts, including a late-breaker on the MAESTRO-NAFLD-1 study, were accepted for oral presentation at the EASL International Liver Congress. The Phase 3 study reinforced resmetirom's safety and efficacy for treating non-cirrhotic NASH. The company anticipates disclosing topline data from the MAESTRO-NASH by Q4 and plans to file for accelerated approval next year. Additionally, Madrigal secured a $250 million term loan facility to support its clinical development and potential U.S. launch of resmetirom.
Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) will announce its Q1 2022 financial results on May 9, 2022, at 6:30 am ET. The announcement will include updates on their clinical programs and further results from the Phase 3 MAESTRO-NAFLD-1 study. Following the press release, a conference call is scheduled for the same day at 8:00 am ET. Investors can access the live webcast on Madrigal's website, where an archived version will be available post-event. Madrigal focuses on novel therapies for non-alcoholic steatohepatitis (NASH), with its lead candidate, resmetirom, in Phase 3 trials.
Madrigal Pharmaceuticals (NASDAQ: MDGL) announced its participation in the 32nd Annual Oppenheimer Healthcare Conference on March 15, 2022, at 8:00 AM ET. The management team will engage in a fireside chat, which will be webcast live. An archived recording will be available post-event on their website. Madrigal focuses on innovative therapeutics for non-alcoholic steatohepatitis (NASH) and leads with resmetirom, currently in Phase 3 studies.
Madrigal Pharmaceuticals (NASDAQ:MDGL) reported significant advancements in its clinical development for non-alcoholic steatohepatitis (NASH) in a recent press release. Key highlights include achieving primary endpoints in the MAESTRO-NAFLD-1 safety study, indicating that resmetirom is safe and effective in reducing liver fat and atherogenic lipids. Financially, the company reported cash reserves of $270.3 million, down from $284.1 million year-over-year, with operating expenses increasing to $242.5 million. The leadership team has been bolstered with new roles to enhance operational capacity.
Madrigal Pharmaceuticals (NASDAQ:MDGL) announced positive topline results from the Phase 3 MAESTRO-NAFLD-1 study of resmetirom, a treatment for non-alcoholic steatohepatitis (NASH). The 52-week double-blind study with 969 patients demonstrated safety and tolerability at doses of 80 mg and 100 mg. Significant reductions in liver fat and atherogenic lipids were achieved, with nearly half of the 100 mg group experiencing a 50% reduction in liver fat. The company plans to share more data from this trial, reinforcing its regulatory strategy for NASH treatment.
Madrigal Pharmaceuticals (NASDAQ: MDGL) plans to announce the topline results from its Phase 3 MAESTRO-NAFLD-1 study of resmetirom on January 31, 2022, at 7:00 am EST. The subsequent conference call is scheduled for 8:00 am EST the same day. This study aims to provide insights into resmetirom's effectiveness for treating fatty liver diseases, particularly non-alcoholic steatohepatitis (NASH). Resmetirom is a first-in-class, liver-directed, thyroid hormone receptor (THR)-β selective agonist currently evaluated in two Phase 3 trials.
Madrigal Pharmaceuticals (NASDAQ: MDGL) appointed Dr. Dominic F. Labriola as Senior Vice President and Chief Data and Analytics Officer. With 35 years of experience, Dr. Labriola previously led global biometrics at Bristol Myers Squibb and will aid in advancing Madrigal's Phase 3 clinical trials for resmetirom, a treatment for non-alcoholic steatohepatitis (NASH). The company anticipates significant data readouts in 2022 that could transform NASH patient care. This strategic hire supports Madrigal's mission to address unmet medical needs in fatty liver diseases.
Madrigal Pharmaceuticals (NASDAQ: MDGL) has announced a delay in releasing the topline 52-week results of the MAESTRO-NAFLD-1 study, now expected in January 2022, due to unforeseen staffing issues at the data analysis vendor. This Phase 3 study evaluates resmetirom in patients with non-alcoholic fatty liver disease, presumed NASH. Enrollment for the study was completed in November 2020 with over 1,200 patients. The company continues its Phase 3 trials, aiming for a potential Subpart H submission to the FDA for accelerated approval of resmetirom.
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