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On March 5, announced EMA validation of the Marketing Authorization Application (MAA) for Rezdiffra; Company
anticipates EMA decision mid-2025 with a country-by-country launch in Europe expected to commence with Germany in second-half
2025, subject to EMA approval. |
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On March 14, received U.S. FDA approval for Rezdiffra, the first and only approved MASH therapy, and
subsequently launched the medicine. |
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On October 21, announced completion of enrollment in the MAESTRO-NASH OUTCOMES study, an event-driven trial
evaluating Rezdiffra in patients with compensated MASH cirrhosis. Positive results could position Rezdiffra to become the first treatment available for this advanced and underserved population. |
J.P. Morgan Healthcare Conference Presentation and Webcast
Bill Sibold, Chief Executive Officer of Madrigal, will discuss these updates as part of a webcast presentation at the 43rd annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 15 at 2:15 p.m. PST (5:15 p.m. EST). The event will be available via live webcast on Madrigals Investor
Relations page [LINK HERE].
About MASH
Metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), is a serious liver disease that can progress to
cirrhosis, liver failure, liver cancer, need for liver transplantation, and premature mortality. MASH is expected to become the leading cause of liver transplantation in the U.S. and is already the leading cause of liver transplantation among women.
Once patients progress to MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes
increases dramatically: these patients have a 10-17 times higher risk of liver-related mortality as compared to patients without fibrosis. Those who progress to cirrhosis face a 42 times higher risk of
liver-related mortality, underscoring the need to treat MASH before complications of cirrhosis develop. MASH is also an independent driver of cardiovascular disease, the leading cause of mortality for patients.
An estimated 1.5 million patients have been diagnosed with MASH in the U.S., and Madrigal is focused on reaching approximately 315,000 patients with
moderate to advanced fibrosis who are under the care of liver specialists. As MASH disease awareness improves and disease prevalence increases, the number of diagnosed patients with MASH with moderate to advanced fibrosis is expected to grow.
About Madrigal
Madrigal Pharmaceuticals,
Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigals medication, Rezdiffra
(resmetirom), is a once-daily, oral, liver-directed THR-ß agonist designed to target key underlying causes of MASH. For more information, visit www.madrigalpharma.com.
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