Why Is Novo Nordisk Stock Popping in Premarket? Wegovy Pill Wins FDA Approval

Novo Nordisk A/S (NVO) stock surged over 7% in premarket trading on Tuesday, December 23, 2025, following a landmark regulatory approval from the U.S. Food and Drug Administration. The FDA greenlit the company’s oral Wegovy weight-loss pill, marking the first-ever oral GLP-1 receptor agonist therapy approved for weight management in the United States.

This breakthrough gives the Danish pharmaceutical giant a significant competitive advantage over its primary rival, Eli Lilly, in the rapidly expanding obesity treatment market. The approval comes after a challenging year for Novo Nordisk, during which the stock has declined 44% year-to-date due to profit warnings and slowing sales of its injectable Wegovy formulation.

FDA Clears First Oral GLP-1 Weight-Loss Treatment

The FDA’s Monday approval of Novo Nordisk’s once-daily oral semaglutide 25 mg tablet represents a turning point for both the company and the weight-loss pharmaceutical industry. Clinical trials demonstrated impressive results, with participants losing an average of 16.6% of their body weight over 64 weeks, compared to just 2.7% for those on placebo.

The pill contains the same active ingredient as the injectable versions of Wegovy and Ozempic, but offers a more convenient delivery method for patients who prefer oral medications over injections.

The approval is particularly significant because it addresses a major barrier to treatment adoption. Many patients avoid injectable medications due to needle aversion or inconvenience, and the oral pill could open access to tens of millions of additional patients.

Novo Nordisk plans to launch the Wegovy pill in the U.S. in early January 2026, with a starting dose of 1.5 milligrams available for $149 per month through pharmacies, select telehealth providers, and President Trump’s direct-to-consumer website, TrumpRx. The medication is approved for adults with obesity or overweight who have at least one related health condition, and also received approval to reduce the risk of major cardiovascular events.

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NVO Stock Jumps as Competitive Position Improves

In premarket trading at 5:09 AM EST on Tuesday, NVO stock jumped to $51.67, up $3.56 or 7.41% from the previous close of $48.09. This surge represents a significant reversal for a stock that has struggled throughout 2025, falling 42.35% year-to-date and 41.85% over the past year.

Despite these declines, Novo Nordisk maintains a substantial market capitalization of $213.73 billion and continues to trade with a forward P/E ratio of 13.18, indicating relatively modest valuation expectations.

Wall Street analysts maintain a Moderate Buy rating on Novo Nordisk stock, based on four Buy ratings, four Hold ratings, and one Sell rating. The consensus price target of $53.71 represents approximately 15% upside potential from current levels, though the recent premarket surge has already captured much of that gap.

The approval gives Novo Nordisk a crucial first-mover advantage over Eli Lilly, which is developing its own obesity pill called orforglipron. While Lilly currently leads the weight-loss injection market with Zepbound, Novo’s pill approval could help the company regain competitive ground. Analysts at HSBC noted that Novo’s clinical data looks “fantastic” with better tolerability and efficacy compared to Eli Lilly’s pill, though it does have food and water restrictions that may complicate prescribing.

The global GLP-1 market could reach $100 billion by 2030, with some forecasts projecting the broader weight-loss market could hit $150 billion annually by the next decade.

Disclaimer: The author does not hold or have a position in any securities discussed in the article. All stock prices were quoted at the time of writing.