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Madrigal Pharmaceuticals Provides an Overview of Upcoming Resmetirom Data Presentations and Reports 2022 Third Quarter Financial Results
Two resmetirom oral abstracts to be presented at the AASLD Liver Meeting®: Phase 3 MAESTRO-NAFLD-1 data demonstrate the potential of resmetirom for the
About this update from Madrigal Pharmaceuticals, Inc.
[{"type":"text","content":"Two resmetirom oral abstracts to be presented at the AASLD Liver Meeting®: Phase 3 MAESTRO-NAFLD-1 data demonstrate the potential of resmetirom for the treatment of patients with compensated NASH cirrhosisScreening data from the Phase 3 MAESTRO-NASH biopsy study provide new insights on noninvasive strategies for patient identification Madrigal remains on track to announce topline data from the Phase 3 MAESTRO-NASH biopsy study in the fourth quarter CONSHOHOCKEN, Pa., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today provides an overview of upcoming resmetirom Phase 3 data presentations and reports third quarter 2022 financial results. Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, “The Madrigal team is focused on delivering topline data from the pivotal MAESTRO-NASH biopsy study in Q4 2022. Positive results from the study would allow us to finalize our new drug application for resmetirom, with the goal of filing for Subpart H accelerated approval in the first half of 2023. The efficacy and safety data we are generating across four Phase 3 MAESTRO studies put Madrigal in a strong position to navigate this accelerated approval pathway and potentially address the unmet needs of patients who currently have no approved therapy to treat NASH with significant fibrosis.” Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, \"The MAESTRO program continues to generate data that reinforce our conviction in the potential of resmetirom to become a foundational therapy for patients with NASH. At the upcoming American Association for the Study of Liver Diseases (AASLD) Liver Meeting, we’ll be presenting results from the compensated NASH cirrhosis cohort studied in MAESTRO-NAFLD-1. The safety and efficacy data in this more advanced patient population helped support our decision to initiate the Phase 3 MAESTRO-NASH Outcomes study, a noninvasive clinical endpoint study that assesses the rate of progression from early well-compensated NASH cirrhosis to decompensated NASH cirrhosis.” Dr. Taub continued, “A second oral presentation at AASLD will examine the ability of several noninvasive strategies to identify NASH patients with significa...