Shares of Wegovy maker Novo Nordisk are rising after approval of the GLP-1 pill

Shares of Novo Nordisk got a much-needed year-end boost as the Wegovy maker became the first drugmaker to win approval for a GLP-1 weight-loss pill, in what one analyst called a “salvation for investors” after the stock’s worst year ever.

The approval of Novo Nordisk’s GLP-1 pill by the US Food and Drug Administration gives the Danish pharmaceutical giant a head start over its US competitor Eli Lillywhich has also applied for FDA approval for its oral weight loss drug, orforglipron.

“As the first oral GLP-1 treatment for people who are overweight or obese, the Wegovy pill offers patients a new, convenient treatment option that can help them begin or continue their weight loss journey,” Novo CEO Mike Doustdar said in a statement late Monday.

Shares closed 9.2% higher on Tuesday.

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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 at pharmacies and through select telemedicine providers with savings offers for $149 per month, Novo said.

Under the agreement Novo Nordisk reached with its government last month, cash-paying patients will be able to access it for the same price through President Donald Trump’s direct-to-consumer website, TrumpRx. Drug prices have been the focus of attention this year as the U.S. seeks to reduce costs paid by consumers.

Redemption for investors?

The approval caps a tumultuous year for Novo, marked by multiple guidelines cuts, mass layoffs, dramatic leadership reshuffles and a high-profile public bidding war against U.S. rival Pfizer.

Novo’s latest news “is a comeuppance for investors,” Denmark’s Jyske Bank analyst Henrik Hallengreen Laustsen told CNBC, especially after a year in which the value of its shares was halved as confidence in Novo’s ability to compete with Eli Lilly and others waned.

“A welcome ‘Christmas present’ for Novo investors – and for patients, as New Year’s weight loss resolutions typically come into effect – as Novo expects to launch the product in early January 2026,” said Hallengreen Laustsen.

“The Wegovy pill represents an important growth driver in the coming years and is a key competitive tool against Eli Lilly, which is expected to receive approval for its oral obesity drug in March-April 2026,” he said, adding that the approval of the Wegovy pill covers both weight control and reducing the risk of adverse cardiovascular events such as strokes and heart attacks.

Novo’s clinical data looks “fantastic,” Rajesh Kumar, head of European life sciences and healthcare equity research at HSBC, told CNBC’s “Squawk Box Europe” on Tuesday.

“In terms of efficacy, Novo’s product looks better, at least in the clinical trials,” Kumar said. “The tolerability looks quite attractive in comparison [Lilly’s orforglipron].

The Wegovy pill has so far shown that it can help patients lose an average of 16.6% of their body weight in about a year. Meanwhile, Lilly’s pill resulted in a 12.4% weight loss in a late-stage clinical trial.

“Novo may actually have an advantage and it will entirely depend on how they go about it,” he added. Still, oral Wegovy must be taken on an empty stomach, and that could make it easier for doctors to prescribe orforglipron to patients, which doesn’t have the same restrictions, due to compliance, Kumar noted.

Novo has stated that it does not consider food restriction to be a significant barrier to oral administration of Wegovy, as it can be taken in the morning on an empty stomach and then patients only need to wait about 30 minutes before eating.

Lilly reported positive results from a maintenance study in which patients switched directly from taking the company’s Zepbound injectable solution Novo NordiskHis rival shot Wegovy. This could help Lilly “retain a little bit of market share,” Kumar said. “That’s the thing we need to pay attention to,” he added.

Worst year ever

While analysts and investors are largely optimistic about the launch of the Wegovy pill in the U.S., investors will be watching to see how Novo and its new pill fare compared to Lilly’s oral version. A first-mover advantage is no guarantee of future industry dominance and success.

Ozempic, which contains the same active ingredient semaglutide as Wegovy but is approved to treat type 2 diabetes, had a four-year lead over Lilly rival Mounjaro. Still, Lilly has now overtaken Novo in U.S. prescriptions as Novo has struggled to meet demand, allowing a prescription pharmacy market to flourish. Lilly’s vaccinations have also been shown to result in greater weight loss.

This caused Novo shares to plunge about 50% in 2025, which was the stock’s worst year on record.

Investors have also raised concerns about Novo’s pipeline and how it may not be able to keep up with that of Lilly’s and other hopeful entrants such as heavyweights Pfizer, AstraZenecaAnd Roche.

—CNBC’s Annika Kim Constantino also contributed to this report.