Shares of Danish pharmaceutical company Novo Nordisk (NVO) rose on Friday after the U.S. Food and Drug Administration (FDA) granted accelerated approval for Wegovy to treat metabolic-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis. This makes Wegovy the first GLP-1 therapy cleared for MASH and the second FDA-approved treatment after Madrigal Pharmaceuticals’ (MDGL) Rezdiffra.
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The FDA’s ruling was based on Part 1 of the ESSENCE trial, where Wegovy improved liver fibrosis in 37% of patients versus 22% on placebo, while nearly twice as many patients saw their liver inflammation resolve. Novo said the drug will be available immediately in the U.S. and should be used alongside diet and exercise.
Stock Reaction
Novo Nordisk’s stock rose about 7% in after-hours trading on Friday, regaining some ground after the recent sell-off. Just weeks earlier, the company had cut its 2025 sales outlook, lowering growth guidance from 13–21% to 8–14%, a move that wiped out nearly $70 billion in market value.
In contrast, Madrigal shares fell more than 6% after Novo’s approval, as investors viewed Wegovy’s entry as a strong competitive threat in the MASH space. At the same time, Eli Lilly (LLY), which is still testing its drug tirzepatide in late-stage trials, may now face added pressure from Novo’s earlier entry into this market.
Analysts estimate that the FDA approval could unlock a $30 billion market for Novo, extending Wegovy’s reach beyond obesity and heart disease into liver care.
What’s Next for NVO Stock?
Novo has filed for Wegovy’s use in Europe and Japan, with final results from Part 2 of the ESSENCE trial expected in 2029. Management is also working with insurers to expand access and reimbursement, though pricing has not yet been disclosed.
For investors, the FDA approval underscores Novo’s strategy to broaden Wegovy beyond weight loss into other areas like liver care. With GLP-1 competition heating up, this FDA approval could serve as a key catalyst and help drive Novo Nordisk’s stock higher in the near term.
Is NVO Stock a Good Buy?
Turning to Wall Street, analysts have a Moderate Buy consensus rating on NVO stock based on two Buys, five Holds, and one Sell assigned in the past three months, as indicated by the graphic below. Furthermore, the average NVO price target of $66.17 per share implies 26.25% upside potential.
