Workflow
NVO Wins FDA Approval for MASH Treatment: ETFs Likely to Gain
Novo NordiskNovo Nordisk(US:NVO) ZACKSยท2025-08-19 11:16

Core Viewpoint - Novo Nordisk's obesity drug Wegovy received accelerated FDA approval for treating metabolic dysfunction-associated steatohepatitis (MASH), leading to a nearly 4% increase in its stock price [1][2]. Group 1: FDA Approval and Drug Efficacy - Wegovy is now the first GLP-1 class treatment authorized for MASH, a liver condition affecting approximately 5% of U.S. adults [3]. - The approval is based on the ESSENCE trial results, showing 62.9% of Wegovy participants achieved resolution of steatohepatitis without worsening fibrosis, compared to 34.3% on placebo [5]. - Additionally, 36.8% of Wegovy participants showed improvement in liver fibrosis without worsening steatohepatitis after 72 weeks, versus 22.4% on placebo [6]. Group 2: Market Impact - Wegovy will be immediately available in the U.S. for MASH treatment, positioning Novo Nordisk favorably in the metabolic disease market [7]. - The only other FDA-approved therapy for MASH is Madrigal Pharmaceuticals' Rezdiffra, which was cleared in 2024, indicating significant market potential for Wegovy [7]. Group 3: Investment Opportunities - Novo Nordisk has substantial exposure in several ETFs, including Roundhill GLP-1 & Weight Loss ETF (OZEM), Amplify Weight Loss Drug & Treatment ETF (THNR), and VanEck Pharmaceutical ETF (PPH) [8].