Novo Nordisk (NVO, Financials), the Danish pharmaceutical company, saw its shares fall sharply Friday after a late-stage trial of its experimental heart medicine failed to meet its primary endpoint.
The company said ziltivekimab did not produce a statistically significant reduction in major adverse cardiovascular events compared with a placebo. Those events included cardiovascular death, nonfatal heart attack and nonfatal stroke.
The trial enrolled more than 6,300 patients with atherosclerotic cardiovascular disease, chronic kidney disease and elevated inflammation. Ziltivekimab blocks the inflammatory IL-6 pathway and was tested alongside standard treatment.
Novo Nordisk said the medicine showed some biological activity, but the effect did not translate into the cardiovascular benefit the company had expected. Overall adverse-event rates were similar between the groups, although serious infections were more common among patients receiving ziltivekimab. Overall mortality was unchanged.
Shares in Copenhagen fell as much as 10%, while the company's U.S.-listed shares were down about 8.6% in premarket trading.
The result adds to concerns about Novo Nordisk's pipeline and execution as the company works to restore investor confidence, particularly in the U.S. market.
Investors will now watch how Novo Nordisk adjusts its cardiovascular development plans and whether other pipeline programs can offset the setback.