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. (MDGL) is a clinical-stage biopharmaceutical company pioneering treatments for metabolic dysfunction-associated steatohepatitis (MASH), including its FDA-approved therapy Rezdiffra. This page provides investors and healthcare professionals with timely updates on corporate milestones, clinical research, and regulatory developments.
Access the latest press releases, earnings reports, and scientific announcements in one centralized location. Key updates include Rezdiffra's commercialization progress, new clinical data analyses, and strategic partnerships advancing MASH treatment innovation. Our curated news collection ensures you stay informed about material events without speculative commentary.
Regular updates cover regulatory submissions, trial expansions, financial disclosures, and patient access initiatives. Content is rigorously verified to provide accurate, actionable information for investment and therapeutic decision-making. Bookmark this page to monitor Madrigal's progress in addressing critical unmet needs in liver disease therapeutics.
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.
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.
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