Madrigal initiates rolling NDA for resmetirom in NASH with liver fibrosis

MADRIGAL PHARMACEUTICALS, INC.

Initiated rolling NDA submission to FDA seeking accelerated approval for resmetirom for NASH with liver fibrosis.
Expects to complete full NDA submission in July 2023; will request priority review.
Resmetirom granted Breakthrough Therapy designation in April 2023 for NASH with liver fibrosis.
NDA based on MAESTRO-NASH biopsy trial meeting both histological improvement endpoints proposed by FDA.
Resmetirom has potential to become first approved therapy for NASH with liver fibrosis if approved.

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