By Sneha S K and Bhanvi Satija
July 31 (Reuters) – Novo Nordisk said on Friday its experimental cardiovascular drug failed to show benefit in a late-stage study, dealing a blow to the Danish drugmaker’s efforts to diversify beyond its blockbuster obesity and diabetes drugs.
The company shares fell 7.3% to 306.50 Danish crowns after results showed the drug, ziltivekimab, failed to reduce the risk of major adverse cardiovascular events (MACE), which include death, non-fatal heart attack and non-fatal stroke, when compared with a placebo.
The disappointing outcome removes one of Novo’s most promising assets outside obesity and diabetes, increasing pressure on the drugmaker to pursue deals and acquisitions to identify new growth drivers, analysts and investors said.
“The trial failure increases the pressure to diversify into other disease areas outside of diabetes and obesity,” said Markus Manns, portfolio manager at Novo shareholder Union Investment.
The results also dent broader efforts to target arterial inflammation to prevent cardiovascular disease.
TD Cowen analysts said it was a surprising result and a missed opportunity as the trial could have added another “leg to the stool” and broadened the Novo narrative.
It could increase pressure on Novo to pivot toward deals to meet investor expectations.
“A large-sized deal in the CV/metabolic or rare disease space could help reignite investor interest,” BMO Capital Markets analysts said.
LOSS OF NON-OBESITY GROWTH DRIVER
The study enrolled more than 6,300 patients with atherosclerotic cardiovascular disease, chronic kidney disease and inflammation to evaluate whether a once-monthly injection of ziltivekimab, a drug that targets the IL-6 protein, could lower the risk of major adverse cardiovascular events.
Novo gained access to ziltivekimab through its $725 million buyout of AstraZeneca spin-off Corvidia Therapeutics in 2020. At the time, the company said it expected the treatment to reach the market in the second half of this decade.
In a previous study, the drug reduced a key marker of blood vessel inflammation by up to 92% without side effects seen with older therapies such as fatal infection risks or cholesterol spikes.
MISSES KEY BENCHMARK
The trial failed to meet the minimum threshold of a 15% relative risk reduction in MACE, a level analysts said was necessary to support the drug’s future commercial and regulatory prospects.
Overall rates of side effects and serious adverse events were similar between the ziltivekimab and placebo groups, though serious infections were more common with ziltivekimab, consistent with IL-6-targeting therapies, Novo said.
In 2018, Novartis’ anti-inflammatory drug canakinumab was rejected by the U.S. Food and Drug Administration after clinical trials showed it reduced major cardiovascular events by about 15% but also doubled the risk of fatal infections, a trade-off regulators deemed unacceptable for preventive treatment.
Novo said the trial outcome would not affect its adjusted operating profit outlook for 2026, but it would lead to a non-cash impairment charge in the third quarter.
The company will continue two ongoing trials of ziltivekimab, one in people with heart failure and another in people following an acute heart attack, with results expected in the first half of 2027.
BMO Capital Markets analysts said that they now view positive data from two other late-stage studies of ziltivekimab as “highly unlikely”.
(Reporting by Siddhi Mahatole and Sneha S K in Bengaluru Bhanvi Satija in London and Boleslaw Lasocki; Editing by Diti Pujara and Anil D’Silva)
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