By Chris Wack

Madrigal Pharmaceuticals Inc. shares were up 12% to $287.57 on Tuesday after the company said that its resmetirom has received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the treatment of patients with nonalcoholic steatohepatitis with liver fibrosis.

The company also said that the outcomes portion of the Phase 3 NASH biopsy trial has completed enrollment.

The new drug application filing for resmetirom remains on track for the second quarter of 2023, the Pennsylvania-based, biopharmaceutical drug company said.

Breakthrough Therapy designation is a process intended to expedite the development and review of drugs for serious or life-threatening conditions. A drug that receives Breakthrough Therapy designation is eligible for more intensive guidance on an efficient drug development program and organizational commitment involving senior managers from FDA.

Madrigal shares are up 275% in the past 12 months.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

April 18, 2023 13:06 ET (17:06 GMT)

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