Denmark pharmaceutical corporations Novo Nordisk, which led the global market with the new obesity drug "Wegovy," has once again tasted defeat in developing a new cardiovascular drug. After failing to meet key endpoints in a late-stage clinical trial, market concerns are growing over its growth strategy concentrated in anti-obesity treatments.
On the 31st (local time), Novo Nordisk said its cardiovascular drug candidate ziltivekimab failed in phase 3 to reduce major adverse cardiovascular events (MACE) versus placebo with statistical significance.
MACE is a core clinical endpoint in cardiology that refers to cardiovascular death, nonfatal myocardial infarction and nonfatal stroke.
More than 6,300 patients with atherosclerotic cardiovascular disease and chronic kidney disease with elevated inflammatory markers participated in the trial.
Ziltivekimab has been developed to lower the risk of cardiovascular events by blocking the interleukin-6 (IL-6) pathway that drives inflammatory responses.
Novo Nordisk said, "We saw improvements in some inflammation-related biomarkers, but they did not translate into a reduction in actual cardiovascular events." Overall adverse event rates were similar to placebo, but serious infections were reported more often in the ziltivekimab arm. There was no difference in all-cause mortality.
Martin Holst Lange, Novo Nordisk's chief scientific officer (CSO), said, "It is disappointing that ziltivekimab did not demonstrate the expected cardiovascular benefit, but we will continue to make strategic investments in the cardiovascular field."
Stock investors reacted immediately. Novo Nordisk shares fell as much as 10% intraday on the Copenhagen exchange, and American depositary receipts (ADR) dropped more than 8% in premarket trading. It is the steepest decline since February, when trial results for the next-generation anti-obesity drug "CagriSema" fell short of market expectations.
Brokerages see the immediate impact of this trial failure on earnings as limited, as ziltivekimab's share of total sales is not large. However, it heightened concerns about the long-term growth strategy.
Investment bank Jefferies said, "Ziltivekimab was one of the most anticipated growth drivers outside the obesity franchise," and "the results show Novo Nordisk still relies heavily on the commercial success of its obesity business and on external technology in-licensing," CNBC reported.
After launching the world's first oral GLP-1 anti-obesity drug "Wegovy" in the United States recently, Novo Nordisk is expanding sales to the United Kingdom and the United Arab Emirates (UAE). In response, Eli Lilly and Company also entered the fray by launching the oral anti-obesity drug "Foundayo" in April.
Even as the market for oral anti-obesity drugs grows, Novo Nordisk's share price remains well below its 2024 peak. The market sees that, amid intensifying pressure from Eli Lilly and Company, the success of new pipelines beyond obesity will determine future corporate value.
Novo Nordisk is scheduled to report second-quarter earnings on Aug. 5 (local time). Investors are watching sales trends for anti-obesity drugs and development strategies for next-generation pipelines such as high-dose Wegovy and CagriSema.