Madrigal Shares Leap Premarket on First FDA NASH Green Light
By Colin Kellaher
Shares of Madrigal Pharmaceuticals surged nearly 25% in premarket trading Friday after the biopharmaceutical company won the first U.S. Food and Drug Administration approval for a drug to treat scarring and fatty deposits that can accumulate in the livers of obese people.
After the closing bell on Thursday, Madrigal said the FDA granted accelerated approval to Rezdiffra, in conjunction with diet and exercise, for adults with noncirrhotic nonalcoholic steatohepatitis, or NASH, with moderate to advanced liver fibrosis.
NASH is also known as metabolic dysfunction associated steatohepatitis, or MASH, after a recent nomenclature change led by global liver-disease medical societies and patient groups.
Madrigal said it expects Rezdiffra to be available to patients in the U.S. in April, adding that the drug's prescribing information doesn't include a liver biopsy requirement for diagnosis.
The company noted that under the FDA's accelerated green light, continued approval of Rezdiffra may be contingent upon verification and description of clinical benefit in ongoing confirmatory studies.
Madrigal shares, which closed Thursday at $243.57, were recently up by more than 24% to $302.90 in premarket trading.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 15, 2024 07:17 ET (11:17 GMT)
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