Madrigal Pharmaceuticals (NASDAQ:MDGL) fell 4% in pre-market trading Monday after the U.S. Food and Drug Administration granted approval to Novo Nordisk’s (NYSE:NVO) Wegovy for treating adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis.
The green light from regulators adds new competitive pressure for Madrigal, whose lead therapy Rezdiffra is also designed for MASH. Rezdiffra is a liver-targeted thyroid hormone receptor beta agonist, and while it remains a core asset for the company, some analysts suggest pairing it with GLP-1 therapies like Wegovy could enhance treatment outcomes.
The FDA’s decision was based on results from Novo’s Phase 3 ESSENCE study. The trial showed 63% of Wegovy patients achieved resolution of steatohepatitis without worsening fibrosis, compared with 34% on placebo. Meanwhile, 37% experienced an improvement in fibrosis without worsening steatohepatitis, versus 22% in the placebo group.
With the approval, Wegovy becomes the first glucagon-like peptide-1 receptor agonist (GLP-1 RA) officially cleared for MASH. The condition affects about 5% of the U.S. population and can progress to cirrhosis or liver cancer if untreated.
“Clear efficacy in MASH coupled with Wegovy’s clean safety profile and broad benefits across metabolic disease should position Novo’s Wegovy (and other GLP-1+ therapies post approval) as a backbone treatment for MASH. Other MOAs like THR-Bs and FGF21s could see use in combination to drive additional efficacy,” said BMO analyst Evan David Seigerman.
Wegovy was first approved in 2021 for weight management in adults with obesity or overweight with weight-related health risks. Its label has since been expanded to adolescents and to reduce cardiovascular risks in certain patients.
Madrigal Pharmaceuticals stock price
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