Novo Nordisk shares received a much-needed end of the year boost as the Wegovy maker became the first drugmaker to secure approval of a GLP-1 pill for weight loss, in what one analyst called a “redemption for the investors” after the stock’s worst year ever.
The U.S. Food and Drug Administration’s approval of Novo Nordisk’s GLP-1 pill gives the Danish pharmaceutical giant a head start over U.S. rival Eli Lilly, which has also filed for FDA approval for its oral weight loss drug orforglipron.
“As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey,” said Novo CEO Mike Doustdar in a statement late Monday.
Shares closed 9.2% higher Tuesday.
Eli Lilly shares have outperformed Novo Nordisk in 2025.
Novo plans to launch oral Wegovy, or “Wegovy-in-a-pill,” in the U.S. – by far its largest market– in early January 2026. The company has also submitted the pill for approval to the European Medicines Agency (EMA) and other regulatory authorities.
Wegovy’s starting dose of 1.5 milligrams will be available in pharmacies and via select telehealth providers with savings offers for $149 per month, Novo said.
Cash-paying patients can access it for the same price via President Donald Trump’s direct-to-consumer website, TrumpRx, according to the deal Novo Nordisk struck with his administration last month. Drug pricing has been top of mind this year as the U.S. looks to reduce the costs paid by consumers.
Redemption for investors?
The approval caps a turbulent year for Novo, which has been marked by multiple guidance cuts, mass layoffs, dramatic leadership shakeups, and a high-profile public bidding war against U.S. rival Pfizer.
Novo’s latest news “is a redemption for the investors,” Danish Jyske Bank analyst Henrik Hallengreen Laustsen told CNBC, especially after a year in which shares halved in value as confidence faltered in Novo’s ability to compete with Eli Lilly and others.
“A welcome ‘Christmas gift’ for Novo investors — and for patients as New Year weight-loss resolutions typically kick in — given that Novo expects to launch the product in early January 2026,” Hallengreen Laustsen said.
“The Wegovy pill represents a key growth driver over the coming years and a critical competitive tool versus Eli Lilly, which is expected to receive approval for its oral obesity drug in March–April 2026,” he said, adding that the Wegovy pill’s approval covers both weight management and reducing the risk of adverse cardiovascular events such as strokes and heart attacks.
Novo’s clinical data looks “fantastic,” Rajesh Kumar, who heads up European life Sciences and healthcare equity research at HSBC, told CNBC’s “Squawk Box Europe” on Tuesday.
“Efficacy-wise, Novo’s product, on the clinical trials at least, looks better,” Kumar said. “Tolerability looks quite attractive compared to [Lilly’s orforglipron].
The Wegovy pill has so far shown that it can help patients lose on average 16.6% of their body weight over about a year. Meanwhile, Lilly’s pill resulted in 12.4% weight loss in a late-stage clinical trial.
“Novo actually might have an edge, and it will entirely depend on how they execute,” he added. Even so, oral Wegovy must be taken on an empty stomach, and that might make it easier for doctors to prescribe orforglipron — which doesn’t have the same restrictions — to patients because of compliance, Kumar noted.
Novo has said it doesn’t see oral Wegovy’s food restriction as a significant barrier, as it can be taken in the morning on an empty stomach and then only requires patients to wait about 30 minutes before eating.
Lilly reported positive findings from a maintenance trial where patients switched directly from taking the company’s injection Zepbound and Novo Nordisk‘s rival shot Wegovy. This may help Lilly “keep a bit of market share,” Kumar said. “That’s the thing we have to watch,” he added.
Worst year ever
Even as analysts and investors alike are mostly optimistic about the Wegovy pill U.S. launch, investors will be watching how Novo and its new pill will fare in relation to Lilly’s oral version. A first-mover advantage is no guarantee for future sector dominance and success.
Ozempic, which contains the same active ingredient semaglutide as Wegovy but is approved for treating type 2 diabetes, had a four-year head start on Lilly rival Mounjaro. Still, Lilly has now overtaken Novo in terms of U.S. prescriptions as Novo has struggled to meet demand, allowing a market for compounding pharmacies to flourish. Lilly’s jabs have also been shown to lead to greater weight loss.
It has led Novo shares to plummet about 50% in 2025, in the stock’s worst year on record.
Investors have also voiced concerns about Novo’s pipeline and how it might not stack up to Lilly’s and other hopeful market entrants such as heavyweights Pfizer, AstraZeneca, and Roche.
— CNBC’s Annika Kim Constantino also contributed to this report.
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