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It may only be getting started.

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Weiss Advocate

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Today’s Exclusive Content

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

Reported by Leo Miller. Article Posted: 12/31/2025. 

At a Glance

• 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 has been 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 the U.S. Food and Drug Administration (FDA) granted approval for Novo’s oral Wegovy weight-loss pill.

Despite that boost, Novo shares have delivered roughly a -40% total return in 2025 as of the Dec. 30 close. The FDA approval, however, could be a catalyst for stronger performance in 2026. Below we look back at the challenges Novo faced in 2025 and update the outlook for NVO stock.

Q3 2025 Shows How Fast the Growth Narrative Changed

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Context matters to understand Novo’s path forward. The company reshaped the weight-loss drug market in 2021 with Wegovy (semaglutide), and the trajectory of its sales growth tells the story of how quickly fortunes shifted.

Novo’s Q3 2025 results are the most recent available report, so we’ll compare year-over-year 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 to just 5% in Q3 2025. The critical inflection point came in November 2023, when the FDA approved Eli Lilly and Company’s (NYSE: LLY) weight-loss drug Zepbound (tirzepatide). That approval helped drive Lilly’s total sales growth of 54% in Q3 2025, a stark contrast with Novo’s 5% result.

By February 2025, Lilly had overtaken Novo in U.S. market share for incretin analogs, according to slide 10 of Lilly’s Q3 presentation. “Incretin analogs” is a broad term for GLP-1 and related drugs. Since then, Lilly’s lead has widened, in part because injectable tirzepatide produces roughly 50% greater weight loss than injectable semaglutide. Novo’s newly approved oral option may help the company regain momentum.

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

Oral weight-loss drugs have become a new battleground between Novo and Lilly. Both companies are targeting patients who prefer to avoid injections; oral formulations can also lower manufacturing costs and improve long-term adherence. Novo’s oral Wegovy gives it several advantages.

First, Novo has a head start: the company expects to begin selling the pill in January 2026. Lilly’s oral candidate, orforglipron, is not yet approved; most analysts expect FDA clearance no earlier than late March 2026. That window could give Novo several months to build share among oral GLP-1 patients.

Efficacy data also favor Novo. Novo’s oral Wegovy showed an average weight loss of 16.6% after 64 weeks in its trial, compared with Lilly’s reported 12.4% average weight loss for orforglipron after 72 weeks in its study (Lilly release).

Adjusting for placebo response and treatment discontinuations narrows the gap—adjusted figures are roughly 11.2% for oral Wegovy versus about 9.1% for orforglipron. Still, oral Wegovy achieved greater weight loss in a shorter time frame, which could encourage both patients and physicians to favor Novo’s pill even after Lilly’s product reaches the market.

What FDA Approval of the Wegovy Pill Changes for 2026

Novo urgently needs a product to reaccelerate growth, and oral Wegovy could be that catalyst. With the stock down sharply in 2025, a solid rebound in 2026 would not be surprising if uptake is strong.

Long-term success, however, depends on continued innovation. One late-stage pipeline candidate, CagriSema, produced average weight loss of 22.7% at 68 weeks and could materially bolster Novo’s position if approved.

Overall, the outlook for Novo shares is tilted to the upside, but oral Wegovy’s sales trajectory in 2026 will be a critical test of the company’s ability to keep pace with Lilly over the longer term.

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