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FDA Approves Novo Nordisk's Wegovy Pill: A Game Changer for 2026
Author: Leo Miller. Article Published: 12/31/2025.
What You Need to Know
- Novo Nordisk shares have come under immense pressure in 2025, losing more than a third of their value.
- However, the company scored a huge win at the end of the year as U.S. regulators approved its weight-loss drug Wegovy in pill form.
- The new drug could help change NVO's fortunes in 2026. However, Eli Lilly remains close on its tail.
After a year that was anything but smooth sailing, pharmaceutical giant Novo Nordisk A/S (NYSE: NVO) is closing out 2025 on a brighter note. Shares jumped about 7% on Dec. 23 after markets reacted to the U.S. Food and Drug Administration's (FDA) approval of Novo's oral Wegovy pill.
Despite that rally, Novo shares posted a total return of roughly -40% for 2025 as of the Dec. 30 close. The FDA approval, however, could catalyze stronger performance for NVO stock in 2026. Below we review the challenges Novo faced in 2025 and provide an updated outlook for the stock.
Q3 2025 Shows How Fast the Growth Narrative Changed
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Context is key. Novo took the weight-loss market by storm in 2021 with Wegovy (semaglutide). Tracking the company's sales growth over recent years shows how that narrative evolved.
Novo's Q3 2025 results are the company's most recent release, so we'll compare Q3 sales growth from 2021 through 2025.
Novo's Q3 Sales Growth by Year
- 2021: 15%
- 2022: 28%
- 2023: 29%
- 2024: 21%
- 2025: 5%
After accelerating through 2023, sales growth collapsed in 2025. The inflection point came in November 2023, when the FDA approved Eli Lilly and Company's (NYSE: LLY) weight-loss drug Zepbound (tirzepatide). Zepbound helped drive Lilly's total sales growth of 54% in Q3 2025—a stark contrast to Novo's 5% figure.
By February 2025, Lilly had overtaken Novo in U.S. market share for the incretin-analogs category (see slide 10 of Lilly's Q3 earnings). "Incretin analogs" is a blanket term for GLP-1 and related drugs. Since then, Lilly's lead has grown, in part because injectable tirzepatide is roughly 50% more effective at inducing weight loss than injectable semaglutide. Novo's oral option, however, may help the company regain momentum.
NVO's Pill: Potential First Mover and Efficacy Advantages Over LLY
Oral weight-loss drugs are a new front in the competition between Novo and Lilly. Both companies want to reach patients averse to injectables and benefit from lower manufacturing costs. The FDA approval of oral Wegovy gives Novo several advantages.
First, Novo has a head start: it expects to begin selling the pill in January 2026. Lilly's oral candidate, orforglipron, is not yet approved; most analysts expect FDA action no earlier than late March. That timing should give Novo several months to capture oral-GLP-1 patients.
Second, efficacy data favor Novo. Novo's oral Wegovy showed average weight loss of 16.6% after 64 weeks, compared with Lilly's report that orforglipron patients lost an average of 12.4% after 72 weeks.
Accounting for placebo effects and patient dropouts narrows the gap—adjusted figures are about 11.2% weight loss for oral Wegovy versus roughly 9.1% for orforglipron.
Still, oral Wegovy produced greater weight loss in a shorter time frame. That could lead patients to remain on Novo's treatment after orforglipron launches and make physicians more likely to prescribe Novo's pill to new patients.
What FDA Approval of the Wegovy Pill Changes for 2026
Novo needs a product that can reaccelerate growth, and oral Wegovy could be precisely that. With shares down sharply, a solid rebound in 2026 would not be surprising.
Long-term success, however, will depend on continuing to deliver improved weight-loss therapies. One late-stage candidate, CagriSema, produced average weight loss of 22.7% at 68 weeks and could play an important role.
Overall, the outlook for Novo shares appears skewed to the upside, but oral Wegovy's sales performance in 2026 will be a key test of the company's ability to keep pace with Lilly over the long term.
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