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June 30, 2023

Madrigal Submits Resmetirom NASH NDA

Here is a brief preview of this blast: Madrigal Pharmaceuticals announced it initiated a rolling submission with FDA for an NDA seeking accelerated approval for resmetirom for the treatment of NASH with liver fibrosis. According to the press release, Madrigal has submitted the majority of the NDA to FDA and plans to submit the remaining components in July 2023 along with a request for priority review. For context, in April 2023, resmetirom received Breakthrough Therapy designation for the treatment of NASH with liver fibrosis (previous FENIX insight). Recall, on June 22, 2023, Madrigal announced new MAESTRO-NASH data at EASL 2023 (previous FENIX insight).