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) reported promising results from the Phase 3 MAESTRO-NASH trial of resmetirom, targeting NASH and liver fibrosis. The study demonstrated significant improvements in primary endpoints, including NASH resolution and fibrosis reduction. These results, validated by consensus reads of biopsy images, will be presented at the NASH-TAG Conference. The company plans to submit a new drug application for resmetirom seeking accelerated approval in 2023, supported by extensive safety and efficacy data from ongoing trials, bolstering its potential market impact in treating NASH.
Madrigal Pharmaceuticals (NASDAQ: MDGL) announced raising $259 million in equity and $50 million in additional debt financing following a positive topline readout from its Phase 3 MAESTRO-NASH trial. This funding will support commercial and clinical activities, including a planned new drug application for resmetirom in the first half of 2023. The company's recent capital raises include $159 million in ATM Program sales and a $100 million securities purchase agreement with institutional investors, confirming strong backing from long-standing investors.
Madrigal Pharmaceuticals (NASDAQ:MDGL) announced positive topline results from its Phase 3 MAESTRO-NASH trial for resmetirom, targeting nonalcoholic steatohepatitis (NASH) with liver fibrosis. The trial demonstrated significant efficacy, achieving primary endpoints with p-values <0.0001. Key outcomes included NASH resolution in 26% and 30% of patients at 80 mg and 100 mg doses, respectively, alongside a substantial LDL reduction. Resmetirom was deemed safe and well-tolerated. Madrigal plans to file for accelerated approval with the FDA in early 2023.
Madrigal Pharmaceuticals (NASDAQ: MDGL) is set to announce topline results from its Phase 3 MAESTRO-NASH study of resmetirom on December 19, 2022. The press release will be available at 7:00 am EST, followed by a conference call at 8:00 am EST. Resmetirom is an innovative oral therapy targeting nonalcoholic steatohepatitis (NASH), an area of high unmet medical need. Madrigal aims to address the underlying causes of NASH through its thyroid hormone receptor-selective approach.
Madrigal Pharmaceuticals (NASDAQ:MDGL) announced it will present two oral abstracts at the AASLD Liver Meeting, showcasing promising Phase 3 data for resmetirom, a potential treatment for compensated NASH cirrhosis. The MAESTRO-NAFLD-1 study indicates significant reductions in cardiovascular risk markers and NASH fibrosis after 52 weeks of resmetirom treatment. Financially, the company reported $153.2 million in cash and equivalents, a decrease from $270.3 million at year-end 2021, fueled by operational expenses of $166.3 million. Upcoming topline data from the MAESTRO-NASH study is expected in Q4 2022.
Madrigal Pharmaceuticals (NASDAQ: MDGL) announced that its management team will participate in a fireside chat at the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 9:30 AM ET. The event will be webcasted, with an archived recording available on the company's website. Madrigal focuses on novel therapeutics for nonalcoholic steatohepatitis (NASH), with its leading candidate, resmetirom, currently undergoing four Phase 3 clinical studies aimed at addressing this significant liver disease.
Madrigal Pharmaceuticals (NASDAQ:MDGL) has initiated the "MAESTRO-NASH Outcomes" study for resmetirom, targeting NASH cirrhosis progression. This Phase 3, double-blind trial will enroll about 700 patients and measure composite liver-related outcomes over 2-3 years. Positive results could support full approval for resmetirom in both noncirrhotic and cirrhotic NASH populations. The study is the fourth in the MAESTRO series, building on previous promising data from earlier trials. Completion and results of this study are crucial for the company’s future prospects.
Madrigal Pharmaceuticals (MDGL) shared updates on its progress and reported Q2 2022 financial results. The company is advancing its Phase 3 MAESTRO-NASH biopsy study, with topline data expected in Q4 2022. Resmetirom, an oral medication targeting NASH, shows promise, supported by positive safety data. As of June 30, 2022, Madrigal reported $211.8 million in cash and equivalents, down from $270.3 million at year-end 2021, driven by operational cash use of $107.3 million. Operating expenses rose to $70.3 million, attributed to increased research activities and headcount.
Madrigal Pharmaceuticals (NASDAQ:MDGL) reported promising results from the Phase 3 MAESTRO-NAFLD-1 study of resmetirom at the EASL 2022. The double-blind trial demonstrated that resmetirom was safe, well-tolerated, and led to significant reductions in liver fat, fibrosis measures, and liver enzymes. In patients with compensated NASH cirrhosis, resmetirom reduced liver volume by ~20%, along with lowering LDL-C and other harmful lipids. The company plans to submit a new drug application based on these findings.
Madrigal Pharmaceuticals announced its support for the fifth International NASH Day on June 9, 2022, highlighting its ongoing commitment to enhancing education and care for patients with non-alcoholic steatohepatitis (NASH). The campaign, led by the Global Liver Institute, aims to raise awareness about the liver disease. Madrigal's initiatives include partnerships with community organizations, unrestricted grants to various liver health programs, and the launch of the NASH Explored campaign for healthcare providers, aimed at disseminating vital information regarding NASH.
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