Shares of Novo Nordisk fell as much as 10% on Friday after the drugmaker said a late-stage heart drug trial failed to reduce major adverse cardiovascular events, or MACE, compared to a placebo.
While the experimental medicine, ziltivekimab, did show some biological effect, it didn’t translate into a statistically meaningful reduction in MACE, defined as cardiovascular death, non-fatal heart attack or non-fatal stroke, for patients with certain diseases, Novo said in a statement on Friday.
The missed endpoint is the latest blow to the Danish drugmaker, which is racing to restore investor confidence in its pipeline and ability to execute, especially in the challenging U.S. market.
“While ziltivekimab did not achieve the MACE benefit we had hoped for, this does not change our strategic commitment to cardiovascular disease,” chief scientific officer Martin Holst Lange said.
Copenhagen-listed shares were last seen down 7.4% while its American depositary receipts were 8.6% lower in premarket trading, on track for their worst day since February when the company released disappointing results from a head-to-head trial of its next-generation weight-loss drug CagriSema versus Eli Lilly’s rival medicine. If losses hold, shares will turn negative for the year.
Jefferies and Citi analysts both said the share move seemed disproportionate given ziltivekimab’s small contribution to Novo’s overall portfolio.
However, “the result is strategically negative as it removes one of Novo’s more credible non-obesity growth opportunities and again reinforces the company’s reliance on commercial execution in obesity and sourcing external innovation for driving growth,” Jefferies said.
Novo Nordisk ADRs year-to-date.
The study tested whether ziltivekimab, which blocks the inflammatory IL-6 pathway, could reduce the risk of a first major cardiovascular event compared with placebo when added to standard treatment.
The trial involved more than 6,300 people who had atherosclerotic cardiovascular disease, chronic kidney disease and elevated inflammation.
Overall adverse-event rates were similar, although serious infections were more common with ziltivekimab. There was no difference in overall mortality.
Cautious optimism
Friday’s blow came amid cautious investor optimism around Novo, mainly due to its successful launch of the Wegovy pill, the first oral GLP-1 for weight loss, in the U.S. in January.
Eli Lilly launched a rival pill, Foundayo, in April, which has seen slower uptake.
Over the summer, Novo launched the pill in the UAE and the U.K., as it looks to translate the U.S. success globally.
Novo shares are still far off where they were two years ago.
Coming into Friday trading, the company’s Danish shares had fallen 7% year-to-date and were down about 70% from their mid-2024 peak. The company is facing intense pressure from Eli Lilly’s rival medicines, which have rapidly gained market share.
Even with the pill momentum, which both Novo and Lilly say is expanding the GLP-1 market rather than eating into the injectables market, Novo remains under pressure as prices are lower and the pill still only accounts for a fraction of its total sales.
Heightened competition has made Novo’s pipeline increasingly important to investors. The company is counting on products including higher-dose Wegovy, oral versions of its medicines and CagriSema to help strengthen its market position.
It’s set to report second-quarter earnings next week, which will provide the next insight for investors on how the obesity market is shaping up.
