Shares of Novo Nordisk (NYSE:NVO) rose 2.4% in pre-market trading Monday in New York after the FDA approved Wegovy for treating metabolic dysfunction-associated steatohepatitis (MASH).
Previously recognized for its weight-loss benefits, Wegovy now expands its use to address liver disease. The FDA granted accelerated approval, marking Wegovy as the first GLP-1-based therapy indicated for adults with moderate to advanced liver fibrosis, a condition affecting roughly 22 million Americans, according to Novo Nordisk.
The drug will now face competition from Madrigal Pharmaceuticals’ Rezdiffra (NASDAQ:MDGL), approved in 2024. Analysts note that Novo Nordisk’s market exclusivity may be short-lived, with Eli Lilly (NYSE:LLY) expected to introduce similar therapies in the coming years.
FDA approval was supported by the ESSENCE clinical trial, which evaluated Wegovy at 2.4 mg weekly. After 72 weeks, patients showed improved liver health and reduced fibrosis compared to placebo.
Executives at Novo Nordisk called the approval a critical milestone for MASH patients, emphasizing that untreated MASH can lead to serious, potentially fatal complications. The company has also submitted applications for regulatory approval in Europe and Japan, based on ESSENCE’s initial results, while the study’s second phase is expected to conclude in 2029.
In Copenhagen, Novo Nordisk shares rose roughly 4% following the news, though the company anticipates a 46% decline by 2025, pressured by competition in weight-loss drugs and internal challenges.
Madrigal Pharmaceuticals stock price
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