Madrigal Pharma Announces Breakthrough Therapy Designation For Resmetirom - Quick Facts

(RTTNews) - Madrigal Pharmaceuticals, Inc. (MDGL) announced that resmetirom has received Breakthrough Therapy designation from the FDA for the treatment of patients with NASH with liver fibrosis.

Paul Friedman, CEO of Madrigal, stated: "The Breakthrough Therapy designation for resmetirom reinforces our confidence in our regulatory strategy as we approach the new drug application filing for resmetirom, which remains on track for Q2 2023. The filing is supported by the positive outcomes on reduction of liver fibrosis and resolution of NASH from the 52-week serial liver biopsy portion of MAESTRO-NASH."

The company also announced that the outcomes portion of the phase 3 MAESTRO-NASH biopsy trial has completed enrollment.

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