Novo Nordisk $NVO ( ▲ 8.67% ) is rallying after the FDA approved its Wegovy weight-loss pill, marking the first oral obesity drug of its kind to clear US regulators. Shares climbed about 7 percent in premarket trading Tuesday as investors digested the significance of the approval.
A first-of-its-kind obesity pill
The Wegovy pill is expected to launch in the US in early January 2026, according to the company. Novo Nordisk said it has already submitted the drug for review in Europe and other regions, with regulatory decisions expected later in 2026. The pill will start at a 1.5 milligram dose and carry an introductory price of $149 per month.
Approval was based on results from Novo’s Oasis 4 trial, which showed patients taking higher daily doses lost an average of 16.6 percent of their body weight over 64 weeks. That puts the pill’s efficacy closer to injectable drugs than many investors expected.
Regaining ground in a heated market
The approval gives Novo Nordisk an important first-mover advantage in oral weight-loss treatments, an area seen as the next major battleground in obesity drugs. That matters after a rough year for the stock, which lost more than half its market value as Eli Lilly $LLY ( ▼ 0.19% ) pulled ahead in US prescriptions with its injectable drug Zepbound.
Lilly has said its own oral obesity drug, orforglipron, could receive FDA approval by March 2026. For now, Novo has the market to itself, and investors are betting that convenience and pricing could help the company claw back momentum in one of the most competitive areas of pharma.