Novo Nordisk's Ziltivekimab failed to reduce cardiovascular events, sending shares down 8%. The company now relies on two remaining trials and its core obesity business.
Alpha Score of 59 reflects moderate overall profile with poor momentum, strong value, moderate quality, moderate sentiment.
Novo Nordisk’s experimental heart drug Ziltivekimab failed a late-stage trial, and the company’s shares fell 8% on Friday.
The trial, called ZEUS, enrolled more than 6,300 patients with cardiovascular disease, chronic kidney disease and ongoing inflammation. The drug lowered inflammation markers as designed, but that biological effect did not turn into fewer heart attacks, strokes or cardiovascular deaths, the company said in a press release.
The hazard ratio came in at 0.99 – patients on the drug had nearly the same risk as those on a placebo. On the safety side, patients on Ziltivekimab had more serious infections than the placebo group, though overall death rates were similar.
Novo’s Danish-listed shares fell 7.5% on the day. U.S.-listed shares dropped 8.6% in early trading, according to CNBC.
The failure is a setback for the Danish drugmaker’s push to diversify beyond its blockbuster weight-loss and diabetes drugs Wegovy and Ozempic. Sell-side analysts had expected Ziltivekimab to generate billions in peak annual sales, and the trial result removes that revenue line from the pipeline.
Novo said it expects a non-cash impairment charge in the third quarter of 2026 tied to the trial. The charge will not affect the company’s adjusted operating profit outlook for the year, the company said.
Two other late-stage trials of Ziltivekimab are still running. HERMES is studying patients with heart failure, and ARTEMIS is studying patients who have recently had a heart attack. Novo expects results from both studies in the first half of 2027. A positive outcome in either one would reopen the cardiovascular opportunity, though there is no guarantee the drug performs better in those populations.
The trial failure arrives days after a U.S. judge ruled that Novo must face part of a shareholder lawsuit tied to the CagriSema weight-loss trial, CNBC reported. That lawsuit centers on what Novo told investors about the design of the REDEFINE-1 trial before disappointing results in December 2024.
AlphaScala’s proprietary score for Novo Nordisk stands at 54 out of 100, a mixed signal. The rating reflects the strength of the core diabetes and obesity business against the uncertainty around pipeline setbacks.
Novo plans to present the full ZEUS data at a medical meeting later this year. The company’s next earnings report, scheduled for the third quarter, will disclose the size of the impairment charge and updated pipeline plans.
The core weight-loss and obesity business remains the main reason to own the stock. The heart pipeline is now an open question, with two shots left at a comeback.
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