Madrigal completes NDA submission to FDA for resmetirom for NASH with liver fibrosis

MADRIGAL PHARMACEUTICALS, INC.

Completed rolling NDA submission to FDA for resmetirom for NASH with liver fibrosis; priority review requested.
Phase 3 MAESTRO-NASH met both primary liver biopsy endpoints: NASH resolution and fibrosis reduction.
Resmetirom granted Breakthrough Therapy designation by FDA in April 2023.
Two ongoing Phase 3 outcomes studies (MAESTRO-NASH-OUTCOMES, MAESTRO-NAFLD-OLE) to support full approval.
No approved therapy exists for NASH; resmetirom targets key underlying causes as THR-β agonist.

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