NVO Stock Gets Major Boost as FDA Approves First Oral GLP-1 Weight Loss Pill

For investors in the healthcare and biotech space, few companies have commanded as much attention in 2025 as Novo Nordisk. But on December 22, the Danish pharmaceutical giant delivered a blockbuster update — the U.S. Food and Drug Administration (FDA) approved its Wegovy® pill, the first oral GLP-1 receptor agonist for weight management. Shares of NVO jumped nearly 8% in after-hours trading, signaling excitement among investors about the company's latest innovation according to the company's announcement.

What is the Wegovy® Pill and Why is it Significant?

The Wegovy pill is a once-daily oral formulation of semaglutide, a GLP-1 (glucagon-like peptide-1) receptor agonist. This drug class has been widely studied for its role in managing obesity and diabetes, with Novo Nordisk's injectable Wegovy already making waves for its effectiveness.

Now, with the approval of an oral version, the company is set to address a major pain point — the inconvenience of injections.

The pill's approval was based on data from the OASIS 4 trial, which showed participants with obesity or overweight and comorbidities lost an average of 16.6% of their body weight. About a third of participants lost 20% or more. These results are comparable to the injectable version and support the pill's potential to significantly impact public health.

The FDA Approval and Market Reaction

The FDA approved the Wegovy pill for reducing excess body weight, maintaining long-term weight loss, and lowering the risk of major cardiovascular events. Novo Nordisk plans to launch the pill in the U.S. in early January 2026 according to official statements.

The regulatory green light was met with a strong market reaction. Shares of NVO surged nearly 8% in after-hours trading, highlighting investor enthusiasm. The stock move contrasted with a slight dip in Eli Lilly's shares, suggesting that investors see Novo Nordisk as the current leader in the obesity drug race according to market analysis.

What This Means for Novo Nordisk and the Obesity Market

The obesity treatment market is growing rapidly as more people seek long-term, effective solutions to manage their weight. The introduction of an oral GLP-1 drug is a game-changer, as it removes a key barrier to adoption — the discomfort and inconvenience of injections. The approval of Wegovy pill could significantly expand Novo Nordisk's market share and revenue potential.

Moreover, Novo Nordisk is not resting on its laurels. The company has also submitted the Wegovy pill for approval in Europe and other regions. It has also filed a New Drug Application for CagriSema, a combination therapy of semaglutide and cagrilintide, which showed a 20.4% mean weight loss in phase 3 trials according to clinical data. These pipeline additions suggest that Novo Nordisk is well-positioned to maintain its leadership in the obesity and diabetes space.

Looking Ahead: Opportunities and Challenges

While the FDA approval is a major win for Novo Nordisk, the company still faces challenges. For example, it recently cut its sales and profit forecasts for 2025, citing weaker-than-expected clinical results for some of its new products and increased competition from rivals. The stock dropped over 21% on the news according to financial reports. Still, the Wegovy pill is likely to mitigate some of these headwinds. With its strong efficacy, convenient oral format, and regulatory approval, the product is poised to drive significant revenue growth in the coming years. Investors will be watching closely how the launch in early 2026 goes and whether demand lives up to expectations.

At the end of the day, Novo Nordisk is navigating a rapidly evolving market. The approval of Wegovy pill is a major milestone, and it could help the company regain investor confidence. If the drug performs as expected, it could be a key driver of growth and a major differentiator in a highly competitive space according to market analysis.