Positive Phase III results for Madrigal’s resmetirom in NASH published

9 February 2024

Despite posting positive clinical trial results for its resmetirom, being trialled in the treatment of non-alcoholic steatohepatitis (NASH,) US drug developer Madrigal Pharmaceuticals (Nasdaq: MDGL) saw its shares close down more than 9% at $173.71 yesterday.

The company announced the publication of the pivotal Phase III MAESTRO-NASH trial of resmetirom in the New England Journal of Medicine.

Resmetirom received Breakthrough Therapy designation from the Food and Drug Administration (FDA) and is under review to become the first medicine approved to treat patients with NASH with liver fibrosis. The FDA granted resmetirom Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) date of March 14, 2024, the target date by which FDA intends to complete its review.

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