Madrigal Pharmaceuticals Soars After Getting FDA Approval for Liver-Scarring Treatment

Shares of Madrigal Pharmaceuticals Inc. (MDGL) skyrocketed Friday after the Food and Drug Administration (FDA) gave accelerated approval for its drug, the first-ever drug to treat scarring caused by fatty liver disease approved by the regulator.

The FDA said Madrigal’s drug Rezdiffra, along with diet and exercise, can be given to patients who are afflicted with noncirrhotic nonalcoholic steatohepatitis, or NASH, and have moderate to advanced liver scarring.

The regulators noted their decision came after 12 months of a 54-month trial that showed “a greater proportion of subjects who were treated with Rezdiffra achieved NASH resolution or an improvement in liver scarring as compared with those who received the placebo.”

The FDA added that continued approval would be based on whether the clinical benefit was seen at the completion of the study.

Company founder Becky Taub pointed out that Madrigal believes Rezdiffra “will change the treatment paradigm for NASH with moderate to advanced liver fibrosis, giving physicians a liver-directed therapy to help improve fibrosis and resolve NASH before their patients progress to cirrhosis.” 

The biotech company said that Rezdiffra was expected to be available to patients in the U.S. next month and be distributed through a limited specialty pharmacy network.

Shares of Madrigal Pharmaceuticals were almost 13% higher at around $274.61 at 1:33 p.m. ET Friday. They have advanced by almost 30% so this year.