The stock has hit its lowest level since June 2021
Novo Nordisk stock plunged as much as 15 per cent on Monday after the Danish drugmaker said its next-generation obesity drug, CagriSema, failed to meet its primary endpoint of demonstrating non-inferiority on weight loss when compared to Eli Lilly's rival drug tirzepatide after 84 weeks, according to the firm’s statement and per CNBC.
Patients taking a 2.4 mg dose of CagriSema achieved weight loss of 23 per cent over the trial period, compared to 25.5 per cent with a 15 mg dose of tirzepatide - the active ingredient behind Lilly's mega-blockbuster medicines Mounjaro and Zepbound, which have already overtaken Novo's semaglutide products, Ozempic and Wegovy, in US prescriptions.
An evolving competitive landscape
The trial was an open-label design, meaning participants knew what treatment they were receiving. But Novo's chief scientific officer Martin Holst Lange told CNBC that such a design can introduce “a risk of bias in favour of a well-known product when compared to an investigational therapy”, adding that he was "surprised" by the 25 per cent weight loss observed with tirzepatide.
Lilly's own previous studies had shown tirzepatide producing a 20.2 per cent weight loss over 72 weeks for people living with obesity or overweight.
Despite the setback, Novo CEO Mike Doustdar remained optimistic about CagriSema's commercial future, stating that the drug - which combines semaglutide and cagrilintide, another hormone released in the pancreas that affects appetite - still offers the "best weight efficacy than any product currently in the market,” he said.
The company has filed CagriSema for approval with the US Food and Drug Administration, with a decision expected by late 2026, and is exploring additional trials including higher-dose combinations.
“CagriSema has the potential to be the first GLP-1/amylin-combination product to reach the market for people living with obesity, documenting that cagrilintide adds to the existing benefits of semaglutide and offers clinically meaningful additive weight loss effects superior to what has been observed with GLP-1 biology alone,” Lange told CNBC, adding that further trials would “assess the full weight-loss potential of CagriSema.”
However, Jefferies analyst Michael Leuchten noted to CNBC that the failure to meet non-inferiority versus Zepbound "adds further uncertainty" to CagriSema's commercial positioning.
He estimated the drug could account for between 15 and 25 per cent of Novo's revenue by 2030 and forecast that Novo could spend up to US$35 billion on mergers and acquisitions this year to bolster its pipeline.
Broader headwinds for Novo Nordisk
The trial result compounds a difficult stretch for Novo Nordisk, whose stock has fallen nearly 50 per cent in 2025 and hit its lowest level since June 2021.
Earlier this month, the company predicted sales and profit growth would decline by between five and 13 per cent in 2026, as it navigates rising competition, lower prices in the US, and the loss of exclusivity for Wegovy and Ozempic in certain markets.
Meanwhile, Eli Lilly guided for sales growth of approximately 25 per cent in 2026, and its stock rose 3.1 percent in premarket trading on the day of Novo's trial results.
Compounding pharmacies that sell copycat versions of semaglutide at reduced prices have further pressured Novo's sales. The company has referred to this as "illegal mass compounding that poses a significant risk to patient safety."
The FDA also recently announced plans to take legal action against telehealth firm Hims & Hers, including restricting its access to ingredients and referring it to the Department of Justice, after the company offered a Wegovy pill copy at a significantly lower price.
