NVO Stock Up on FDA Nod for Wegovy in MASH: More Upside Ahead?

Core Insights - Novo Nordisk's Wegovy (semaglutide 2.4 mg) received accelerated FDA approval for treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis, marking a significant advancement in liver disease treatment [1][10] Group 1: Regulatory Approval and Clinical Data - The FDA's approval was based on data from the ESSENCE study, which demonstrated Wegovy's effectiveness in improving liver fibrosis and resolving steatohepatitis compared to placebo [2][3] - At week 72, 36.8% of Wegovy patients showed improvement in liver fibrosis without worsening steatohepatitis, while 62.9% achieved resolution of steatohepatitis without worsening liver fibrosis [3] Group 2: Market Position and Financial Performance - Wegovy generated DKK 36.9 billion in sales in the first half of 2025, reflecting a 78% year-over-year increase driven by strong prescription growth [5] - Novo Nordisk's stock price has decreased by 39% year-to-date, underperforming the industry and the S&P 500 [11] Group 3: Competitive Landscape - Eli Lilly is a key competitor in the obesity treatment market, with its tirzepatide products generating combined sales of $14.7 billion in the first half of 2025, accounting for 52% of Lilly's total revenues [7] - Novo Nordisk is seeking FDA approval for a 25 mg oral semaglutide for obesity, which could provide a competitive edge as the sole manufacturer of an oral obesity pill [8] Group 4: Future Outlook - Earnings estimates for 2025 have declined from $3.98 to $3.89 per share, and for 2026 from $4.57 to $4.24 [14]