Welcome to our dedicated page for Madrigal Pharmac news (Ticker: MDGL), a resource for investors and traders seeking the latest updates and insights on Madrigal Pharmac 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) 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.
Madrigal Pharmaceuticals (NASDAQ: MDGL) has announced participation in two upcoming virtual investor conferences. Management will hold a fireside chat at the Evercore ISI 4th Annual HealthCONx Conference on November 30, 2021, at 9:40 AM EST, and at the Piper Sandler 33rd Annual Virtual Healthcare Conference on December 2, 2021, at 11:30 AM EST. The presentations will be webcast live and archived for 90 days on the Madrigal website. The company is focused on developing therapies for cardio-metabolic diseases, particularly NASH, with its lead candidate resmetirom currently in Phase 3 studies.
Madrigal Pharmaceuticals (MDGL) presented positive findings from the 52-week open-label study of resmetirom at the AASLD 2021. The study included 171 patients with presumed NASH and fibrosis. Key results showed:
- Significant reductions in liver fat and volume.
- Improvements in liver fibrosis, measured by biomarkers and imaging.
- Reduction in atherogenic lipids and liver enzymes.
- Resmetirom was well-tolerated with no safety concerns.
The ongoing Phase 3 MAESTRO-NAFLD-1 study aims to further evaluate resmetirom's efficacy.
Madrigal Pharmaceuticals (NASDAQ:MDGL) reported its Q3 2021 financial results, highlighting progress in its Phase 3 MAESTRO-NASH and MAESTRO-NAFLD-1 studies. The company's cash and marketable securities increased to $299.1 million, aided by $151.2 million from stock sales. Operating expenses rose to $63.2 million, reflecting higher R&D costs related to clinical trials, totaling $54.9 million for Q3. The company will present data from the MAESTRO-NAFLD-1 study at the AASLD’s upcoming meeting, slated for November 12-15, 2021.
Madrigal Pharmaceuticals (NASDAQ:MDGL) collaborates with the Fatty Liver Foundation to recognize Liver Awareness Month by ringing the Nasdaq closing bell, aiming to highlight the critical need for NAFLD/NASH awareness. NAFLD affects over 16 million Americans, with NASH being the leading cause of liver transplants. Madrigal supports the NAFLD Screening Fund to promote evidence-based screening for early detection of these conditions. The initiative is intended to enhance understanding and diagnosis of NAFLD/NASH, as well as guide affected patients to necessary care.
Madrigal Pharmaceuticals (NASDAQ:MDGL) announced its Q2 2021 financial results, highlighting significant advancements in its MAESTRO clinical trials for NASH treatment, including successful patient enrollment for accelerated approval. The company has over 2,000 patients enrolled across these trials, with promising results in liver fat reduction. As of June 30, 2021, Madrigal reported cash and marketable securities totaling $323.8 million, up from $284.1 million at year-end 2020. Operating expenses increased due to heightened R&D efforts, amounting to $61.7 million for the quarter.
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.
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