Novo Nordisk shares jump as FDA accepts oral Wegovy application

May 03, 2025 06:11 AM AEST | By Investing

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Novo Nordisk shares jump as FDA accepts oral Wegovy application

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Investing.com -- Novo Nordisk (NYSE:NVO) shares climbed 5.4% Friday after the U.S. Food and Drug Administration accepted the company’s New Drug Application for an oral version of Wegovy. If approved, the pill formulation would be the first oral GLP-1 treatment for chronic weight management in adults with obesity or overweight conditions.

The submission is based on results from the phase 3 OASIS 4 trial, which studied a 25 mg dose of oral semaglutide in adults without diabetes but with obesity or at least one comorbidity. The 64-week trial supported the company’s push to expand Wegovy’s label beyond its current injectable form.

“We are pleased with the FDA’s acceptance of our submission,” said Anna Windle, Senior Vice President at Novo Nordisk. She added the company looks forward to collaborating with regulators on what could be “a groundbreaking treatment option for obesity.”

The FDA’s final decision is expected in the fourth quarter of 2025. Investors appear optimistic that an oral version of the blockbuster drug could expand adoption and solidify Novo Nordisk’s lead in obesity care.

The announcement follows news that CVS (NYSE:CVS) Caremark will make Wegovy its preferred GLP-1 therapy beginning July 1. The agreement includes enhanced lifestyle support under CVS’s weight management program, broadening access at lower cost.

Meanwhile, key competitor Eli Lilly and Company (NYSE:LLY) continues development of its own oral GLP-1, orforglipron, which is still in clinical trials. Lilly expects to file for regulatory approval for obesity treatment later this year and for type 2 diabetes in 2026.

Despite Novo Nordisk’s potential first-mover advantage in the oral GLP-1 market, Lilly shares were also higher Friday, up 3.9%, rebounding from a previous session’s losses. The gains follow a volatile week in the weight loss drug sector.

Novo Nordisk’s long-term obesity strategy continues to drive investor enthusiasm, with the oral formulation potentially serving as a critical convenience upgrade. The FDA’s acceptance brings the company one step closer to expanding its GLP-1 footprint.

This article first appeared in Investing.com

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