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, Inc. (NASDAQ:MDGL) announced on April 18, 2023, that the FDA granted Breakthrough Therapy designation for its drug resmetirom, aimed at treating nonalcoholic steatohepatitis (NASH) with liver fibrosis. The company also revealed that the Phase 3 MAESTRO-NASH trial has completed enrollment, targeting approximately 1,750 patients. CEO Paul Friedman indicated that the designation reflects the FDA's acknowledgment of resmetirom's potential as a significant therapeutic option for NASH. The company expects to file a New Drug Application (NDA) for resmetirom in Q2 2023 based on positive liver fibrosis outcomes from the ongoing trials. Madrigal is committed to demonstrating resmetirom's efficacy through multiple Phase 3 studies, including MAESTRO-NASH-OUTCOMES, which is vital for regulatory approval.
Madrigal Pharmaceuticals (NASDAQ:MDGL) reported robust financial results for 2022, highlighting a year-end cash position of $358.8 million, up from $270.3 million in 2021. The company is advancing regulatory preparations for resmetirom, following positive Phase 3 MAESTRO-NASH study results, which demonstrated both NASH resolution and fibrosis improvement. These results support a New Drug Application (NDA) filing projected for the first half of 2023. Operating expenses rose to $293.6 million for the year, attributed to increased clinical trial activities and commercial preparations.
Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a clinical-stage biopharmaceutical firm, targets therapies for nonalcoholic steatohepatitis (NASH). The company's management will present at three key investor conferences: the SVB Securities Global Biopharma Conference on February 14, Cowen Annual Healthcare Conference on March 6, and the Oppenheimer Annual Healthcare Conference on March 13, 2023. Each presentation will be available via webcast, and recordings will be archived on Madrigal’s website. Madrigal’s lead candidate, resmetirom, is designed to address significant unmet needs in NASH.
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