Aug 18 - Novo Nordisk won accelerated FDA approval for Wegovy to treat metabolic-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis, expanding the GLP-1 therapy's reach. The decision follows Part 1 of the ESSENCE trial, where 37% of patients on Wegovy improved fibrosis versus 22% on placebo, and nearly twice as many saw inflammation resolve. Novo said the drug will be available immediately in the U.S. and should pair with diet and exercise.
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Shares rose about 3% early trading as investors digested the news following a sell-off after the company trimmed its 2025 sales outlook. The approval makes Wegovy the first GLP-1 cleared for MASH and the second FDA-approved liver drug after Madrigal Pharmaceuticals' Rezdiffra, intensifying competition.
Madrigal (MDGL) shares fell, while Eli Lilly (LLY) faces added pressure as it advances tirzepatide trials. Analysts estimate the MASH market could reach $30 billion, depending on pricing, reimbursement, and rollout. Novo filed for Wegovy use in Europe and Japan and expects final ESSENCE Part 2 results in 2029. Investors should watch access, pricing decisions, and payer negotiations as key drivers for revenue and margins.
This article first appeared on GuruFocus.
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Why Nova Nordisk (NVO) Stock Is Climbing Today
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Aug 18, 2025 at 12:37 PM
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