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Madrigal Pharmaceuticals Provides Corporate Updates and Reports Second Quarter 2023 Financial Results
Resmetirom new drug application (NDA) submitted to the U.S. Food and Drug AdministrationNASH disease education and market development activities expand to
About this update from Madrigal Pharmaceuticals, Inc.
[{"type":"text","content":"Resmetirom new drug application (NDA) submitted to the U.S. Food and Drug AdministrationNASH disease education and market development activities expand to support potential first-to-market launch in the U.S. CONSHOHOCKEN, Pa., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today provides a summary of recent corporate accomplishments and reports second quarter 2023 financial results. Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, “The recent submission of the resmetirom NDA represents an important milestone for Madrigal and the NASH community. Based on the depth and breadth of efficacy and safety data we have generated through the MAESTRO program, I believe we are well-positioned to support the FDA’s review of resmetirom. In parallel with our regulatory activities, our Commercial and Medical Affairs teams are intently focused on preparing for a potential first-to-market launch in the U.S.” Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “In addition to the positive biopsy results supporting our regulatory filings in the U.S. and Europe, the MAESTRO program has generated extensive biomarker and imaging data to help advance noninvasive strategies that may be used in real-world clinical practice to identify appropriate patients for resmetirom and monitor treatment response. The MAESTRO-NASH results were featured in the opening session of the EASL Congress earlier this summer, and we look forward to presenting additional noninvasive data from the study at future scientific congresses.” Remy Sukhija, Chief Commercial Officer of Madrigal, added, “As a once-daily, oral medication that is intended to treat the underlying causes of NASH in the liver, resmetirom has a unique opportunity to become the foundational therapy for patients with NASH with liver fibrosis. Our conviction in resmetirom’s potential is grounded in extensive market research with hepatologists and gastroenterologists. Based on the efficacy and safety data observed in the MAESTRO-NASH trial, these liver specialist physicians report strong intent-to-prescribe resmetirom for appropriate patients, if approved.” Mr. Sukhija continued, “NASH care pathways are evo...