Novo Nordisk rallies after FDA weight-loss pill approval

Novo Nordisk’s US-listed shares are up 7% in premarket trading on Tuesday after the US Food and Drug Administration approved its Wegovy weight-loss pill on Monday evening.

Now the first pill of its kind to receive approval from the regulator, Novo’s Wegovy pill is expected to launch in the US in early January 2026, and awaits the European Medicines Agency and other regulatory authorities’ approval after submitting for review in the second half of 2025, per the company’s press release. The 1.5-milligram starting dose of the pill will be sold at an introductory price of $149 a month.

“The pill is here. With today’s approval of the Wegovy^® pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy^® injection,” said Mike Doustdar, president and CEO of Novo Nordisk.

The approval was based on Novo’s Oasis 4 trial, which found participants who took 25-milligram doses of Wegovy pills daily lost 16.6% of their body weight over a 64-week period.

The approval will give Novo — which lost more than 50% of its market cap this year after Eli Lilly took the crown in weekly US prescriptions for injectable weight-loss drugs with its product Zepbound — a first-mover advantage in the expanding market. Lilly, which is down some 1% in premarket trading today, has said its own oral drug, orforglipron, could be approved by March 2026.