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 strong preliminary results for Q4 and full-year 2024. The company reported Q4 Rezdiffra net sales between $100-103 million and full-year sales of $177-180 million. As of year-end 2024, the company maintains a robust cash position of approximately $931 million and has more than 11,800 patients on Rezdiffra.
2024 marked a pivotal year for Madrigal with several key achievements: Rezdiffra received FDA approval in March as the first and only approved treatment for MASH (metabolic dysfunction-associated steatohepatitis), the EMA validated their Marketing Authorization Application, and enrollment was completed in the MAESTRO-NASH OUTCOMES study for compensated cirrhosis patients. The company plans European expansion starting with Germany in H2 2025, pending EMA approval expected mid-2025.
Madrigal Pharmaceuticals (Nasdaq: MDGL) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's presentation is scheduled for Wednesday, January 15, 2025, at 2:15 pm PT. Interested parties can access the live webcast through either a direct link or via the Events and Presentations section of Madrigal's Investor Relations website.
Madrigal Pharmaceuticals (Nasdaq: MDGL) has announced its participation in three major investor conferences. The company will engage in fireside chats at the UBS Global Healthcare Conference on November 13, 2024 at 2:00 PM EST, the 7th Annual Evercore HealthCONx Conference on December 4, 2024 at 9:35 AM EST, and the Piper Sandler 36th Annual Healthcare Conference on December 5, 2024 at 8:30 AM EST. All presentations will be available via live webcast through Madrigal's Investor Relations Events page.
Madrigal Pharmaceuticals (MDGL) reported Q3 2024 net sales of $62.2 million for Rezdiffra™. The company achieved over 80% commercial coverage ahead of schedule, with less than 5% of covered lives requiring biopsy. Operating expenses were $178.5 million, up from $98.5 million year-over-year. The company maintains a strong financial position with $1.0 billion in cash and equivalents. Enrollment was completed in the MAESTRO-NASH OUTCOMES trial for NASH cirrhosis patients, potentially expanding Rezdiffra's indication. The European regulatory decision is expected mid-2025.
Madrigal Pharmaceuticals (NASDAQ:MDGL) announced multiple presentations on Rezdiffra™ (resmetirom) at the upcoming AASLD Liver Meeting in San Diego (November 15-19, 2024). The company will present eleven abstracts, including two oral presentations featuring new results from the Phase 3 MAESTRO-NASH trial.
Rezdiffra, the first approved medication for NASH treatment, is a once-daily, oral, liver-directed thyroid hormone receptor THR-β agonist. In the pivotal Phase 3 trial, 80% of patients treated with Rezdiffra 100 mg showed improvement or stabilization of fibrosis. The drug is indicated for adults with noncirrhotic NASH with moderate to advanced liver fibrosis.
The presentations will cover various aspects, including the drug's effects on patients with different weight loss profiles, genetic risk factors, and its impact on liver enzymes.
Madrigal Pharmaceuticals (NASDAQ:MDGL) has completed enrollment for its MAESTRO-NASH OUTCOMES trial, evaluating resmetirom for treating compensated NASH cirrhosis. The study, which exceeded its initial target with 845 patients, could potentially make resmetirom the first approved medication for this high-risk population. It may also support full approval of Rezdiffra (resmetirom) in noncirrhotic NASH.
The trial is a Phase 3, double-blind, randomized, placebo-controlled study measuring progression to liver decompensation events. Patients are randomized 3:1 to receive 80 mg resmetirom or placebo daily. The study is expected to last two to three years. Madrigal's CEO, Bill Sibold, emphasized the urgent need for therapies preventing progression to decompensated cirrhosis and reducing liver transplants due to NASH.
Madrigal Pharmaceuticals (Nasdaq: MDGL) has announced it will release its third-quarter 2024 financial results on Thursday, October 31, 2024, before the U.S. financial markets open. Following this, the company's management will host a live webcast at 8 a.m. Eastern Time to review Madrigal's financial and operating results.
Interested parties can access the webcast through the Investor Relations section of Madrigal Pharmaceuticals' website. To ensure a timely connection, participants are advised to register at least 15 minutes before the scheduled start. The webcast will remain available for approximately two hours after the live event concludes.
Madrigal Pharmaceuticals (Nasdaq: MDGL) has announced its participation in the H.C. Wainwright 8th Annual MASH Virtual Investor Conference. The event will feature a fireside chat scheduled for 2:00 P.M. ET on Monday, Oct. 7, 2024. The session will be webcast live and can be accessed through a provided link or via Madrigal's Investor Relations Events page. A replay of the webcast will be available after the event.
Madrigal Pharmaceuticals (Nasdaq: MDGL) has appointed Dr. Michael R. Charlton as Senior Vice President, Clinical Development, effective October 1, 2024. Dr. Charlton brings over 30 years of leadership experience in hepatology, gastroenterology, and liver transplantation, with particular expertise in NASH. He has held academic leadership roles at Mayo Clinic, University of Chicago, and Intermountain Medical Center.
Dr. Charlton's extensive research in NASH has resulted in over 200 publications, including authoring guidelines for the American Association for the Study of Liver Diseases. His appointment reflects Madrigal's commitment to innovation in NASH R&D, following the development of their breakthrough therapy, Rezdiffra (resmetirom).
Madrigal Pharmaceuticals (NASDAQ:MDGL) has announced the publication of positive patient-reported outcomes data from the Phase 3 MAESTRO-NASH trial of Rezdiffra™ (resmetirom) in Hepatology. The study showed that Rezdiffra, the first FDA-approved medication for NASH, improved health-related quality of life (HRQL) in patients with moderate to advanced fibrosis.
Key findings include:
- Clinically meaningful and statistically significant improvements in emotional well-being and health distress
- Positive tolerability profile of Rezdiffra
- Improvements in multiple HRQL domains, including Worry, Health Distress, and Stigma
- No worsening of HRQL related to potential side effects
Rezdiffra is a once-daily, oral, liver-directed thyroid hormone receptor (THR)-β agonist indicated for treating adults with noncirrhotic NASH with moderate to advanced liver fibrosis.
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