Shares of Danish pharmaceutical company Novo Nordisk rose sharply after the U.S. Food and Drug Administration approved its oral weight-loss pill, branded Wegovy, marking the first oral GLP-1 receptor agonist cleared for chronic weight management.
The stock climbed more than 7 percent in early trading following the approval, reflecting investor optimism after a turbulent year for the company.
Novo Nordisk plans to launch the oral Wegovy pill in the U.S.—its largest market—in early January 2026. The starting dose of 1.5 milligrams will be available in pharmacies and through select telehealth providers at $149 per month with savings programs.
Cash-paying patients can also access the pill via the direct-to-consumer platform TrumpRx under an agreement with the U.S. administration. The company has also submitted the pill for approval to the European Medicines Agency and other international regulators.
The Rockville, Maryland, facility that manufactures Wegovy includes two Current Good Manufacturing Practices plants with a combined 60,000 liters of drug substance capacity, supporting both clinical and commercial production. Existing products will continue at the site, and Samsung Biologics plans further investments to expand capacity and upgrade technology, strengthening the U.S. supply chain for critical biologics. More than 500 employees at the site will be retained to ensure operational continuity.
Clinical trials have shown that patients taking oral Wegovy lost an average of 16.6 percent of body weight over approximately a year, outperforming Eli Lilly’s comparable oral GLP-1 candidate, orforglipron, which produced 12.4 percent weight loss. The pill also reduces the risk of cardiovascular events such as strokes and heart attacks, making it a potential competitive advantage for Novo. The drug must be taken on an empty stomach, though the company has said this is not expected to be a barrier to patient compliance.
The FDA approval comes after a challenging year for Novo Nordisk, marked by guidance cuts, layoffs, leadership changes, and competition in the obesity treatment market. Analysts view the approval as a “redemption” for investors, positioning the Wegovy pill as a key growth driver and an important tool against rivals.
The commercial launch in early 2026 is expected to expand access to obesity treatment in the U.S., meeting rising patient demand for effective oral therapies while reinforcing Novo Nordisk’s competitive position globally.
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