FDA accepts Madrigal's NDA for resmetirom for NASH with fibrosis, grants Priority Review

MADRIGAL PHARMACEUTICALS, INC.

PDUFA target action date set for March 14, 2024; FDA not currently planning an advisory committee meeting.
Priority Review shortens review to 6 months vs standard 10 months for a serious condition.
NDA supported by positive Phase 3 MAESTRO-NASH biopsy endpoints and large safety database from 18 studies.
Resmetirom is a once-daily oral THR-β agonist targeting key underlying causes of NASH in the liver.

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