FDA Approves Novo Nordisk's Wegovy Pill: A Game Changer for 2026

After a year that has been anything but smooth sailing, pharmaceutical giant Novo Nordisk A/S (NYSE: NVO) is closing out 2025 on a positive note. Shares received a significant 7% boost on Dec. 23. That day, markets reacted to the U.S. Food and Drug Administration's (FDA) approval of Novo’s weight loss pill.

While Novo shares have delivered a total return of around -40% in 2025 as of the Dec. 30 close, the FDA approval is a development that could catalyze stronger performance for NVO stock in 2026. Let’s dive into the difficulties that Novo has faced in 2025 and gain an updated outlook on the stock going forward. 

Q3 2025 Shows How Fast the Growth Narrative Changed

To understand Novo’s path forward, context is key. The company took the weight loss drug market by storm in 2021 through the approval of Wegovy, clinically known as semaglutide. Observing the progression of Novo’s sales growth tells the company’s story over the past few years.

Novo’s Q3 2025 results are the most recent release from the company.

Thus, we’ll track the Q3 sales growth from 2021 to 2025 to compare the numbers apples-to-apples.

Novo’s Q3 Sales Growth by Year

• 2021: 15%
• 2022: 28%
• 2023: 29%
• 2024: 21%
• 2025: 5%

After sales growth accelerated through 2023, the number fell off a cliff last quarter. The critical inflection point came in November 2023, when the FDA approved Eli Lilly and Company’s  (NYSE: LLY) weight loss drug Zepbound, clinically known as tirzepatide. Zepbound helped drive Lilly’s total sales growth of 54% in Q3 2025, a massive contrast to Novo’s 5% figure.

By February 2025, Lilly had overtaken Novo in terms of market share in the U.S. incretin analogs market, as seen on slide 10 of Lilly's Q3 earnings. “Incretin analogs” is a blanket term used to describe GLP-1 and similar drugs. Since then, Lilly’s lead has only grown. This comes as injectable tirzepatide is about 50% more effective at inducing weight loss than injectable semaglutide. However, Novo’s latest drug may allow the company to regain momentum in a war it is losing.

NVO’s Pill: Potential First Mover and Efficacy Advantages Over LLY

Oral weight loss drugs have become a new front on which Novo and Lilly are competing. Both companies aim to reach patients who are averse to injectables, and benefit from lower manufacturing costs while helping patients maintain their weight loss. The approval of its oral Wegovy pill gives Novo the high ground in multiple ways.

First off, Novo has a head start on Lilly, as it expects to begin selling the pill in January 2026. Meanwhile, Lilly’s oral solution, orforglipron, is not yet approved. Most expect that the FDA will approve orforglipron, but not until late March at the earliest. This means Novo will likely have several months to gain market share among oral GLP-1 patients.

Additionally, the efficacy of the two drugs shows that Novo may be able to maintain its lead. Novo’s latest data on oral Wegovy showed that patients lost 16.6% of their weight on average after 64 weeks. This compares favorably to a study that Lilly released in September which showed that orforglipron patients lost an average of 12.4% of their weight after 72 weeks.

Adjusting for placebo weight loss and patients who discounted the treatments narrows this lead—adjusted figures are approximately 11.2% weight loss for oral Wegovy, and approximately 9.1% weight loss for orforglipron.

Still, oral Wegovy patients lost more weight than orforglipron patients in a shorter amount of time. This difference could lead patients to stay on oral Wegovy even after orforglipron’s release and make doctors more likely to recommend Novo’s treatment to new patients.

What FDA Approval of the Wegovy Pill Changes for 2026

Novo urgently needs a product that will reaccelerate its growth, and oral Wegovy could be precisely that. With shares down significantly, it would not be surprising to see Novo shares rebound solidly in 2026.

However, the firm's long-term success will be predicated on its ability to continue delivering new and improved weight loss treatments. One drug in the late-stage pipeline, CagriSema, helped patients lose an average of 22.7% of their weight at 68 weeks, and could go a long way in achieving this.

Overall, the outlook on Novo shares looks solidly skewed to the upside. However, oral Wegovy’s sales growth in 2026 will be key to evaluating the firm’s ability to keep up with Lilly long-term.

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The article "FDA Approves Novo Nordisk's Wegovy Pill: A Game Changer for 2026" first appeared on MarketBeat.