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Madrigal Pharmaceuticals Provides Corporate Updates and Reports First Quarter 2023 Financial Results
Resmetirom new drug application (NDA) filing on track for Q2 2023Resmetirom has received Breakthrough Therapy designation from FDA Multiple resmetirom
About this update from Madrigal Pharmaceuticals, Inc.
[{"type":"text","content":"Resmetirom new drug application (NDA) filing on track for Q2 2023Resmetirom has received Breakthrough Therapy designation from FDA Multiple resmetirom abstracts accepted for presentation at EASL, including primary results and additional data from the Phase 3 MAESTRO-NASH trial CONSHOHOCKEN, Pa., May 09, 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 corporate updates and reports first quarter 2023 financial results. Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, “In the first quarter of 2023, the Madrigal team made significant progress advancing our regulatory preparations, disease education initiatives, and market access strategy. Additionally, we continue to execute against our clinical development objectives, and have completed enrollment of the MAESTRO-NASH trial. We are working diligently on the resmetirom approval process and recently announced that we obtained Breakthrough Therapy designation for resmetirom, reinforcing our confidence in our regulatory strategy and the planned NDA filing in Q2 2023.” Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “The MAESTRO-NASH primary trial data will be the opening presentation in the first general session of EASL’s International Liver Meeting in June; we look forward to sharing additional results from the study and engaging in scientific exchange at this important scientific forum. In addition to our primary oral presentation focused on the MAESTRO-NASH biopsy results, we’ll be presenting several abstracts from the MAESTRO program that provide a broader view of resmetirom treatment response.” Recent Corporate Highlights Madrigal announced that resmetirom has received Breakthrough Therapy designation from the FDA for the treatment of patients with NASH with liver fibrosis. A drug that receives Breakthrough Therapy designation is eligible for more intensive guidance on an efficient drug development program and organizational commitment involving senior managers from FDA.The MAESTRO-NASH registrational trial in noncirrhotic NASH has completed enrollment.Patient recruitment remains focused on MAESTRO-NASH-OUTCOMES, a noninvasive Phase 3 clinical outcome t...