- Novo Nordisk's investigational anti-inflammatory drug, ziltivekimab, failed to reduce the risk of major heart events in a pivotal trial, raising questions about targeting inflammation to prevent cardiovascular complications.
- In a Phase 3 study involving over 6,300 patients with heart disease, kidney disease, and inflammation, ziltivekimab did lower markers of inflammation but did not translate into a reduction in major complications.
- Shares of Novo Nordisk fell about 7% following the trial results, indicating a significant market reaction to the failed study.
- The trial's failure removes one of Novo's most promising assets outside obesity and diabetes, increasing pressure on the company to pursue new growth opportunities.
- Weight loss drug stocks slumped on Friday amid company updates and ahead of earnings, with Novo's stock sinking below a key buy point.
- Novo Nordisk gained access to ziltivekimab through its $725 million buyout of AstraZeneca spin-off Corvidia Therapeutics in 2020.
- The trial failed to meet the minimum threshold of a 15% relative risk reduction in major adverse cardiovascular events, which analysts deemed necessary for the drug's future prospects.
- Despite the trial outcome, Novo stated it would not affect its adjusted operating profit outlook for 2026, but would lead to a non-cash impairment charge in Q3.
- Novo Nordisk will continue two ongoing trials of ziltivekimab, with results expected in the first half of 2027.
Novo Nordisk's ziltivekimab, an anti-inflammatory drug, failed to meet the minimum threshold of a 15% relative risk reduction in major adverse cardiovascular events (MACE) during a Phase 3 trial involving over 6,300 patients with heart and kidney diseases.19
"The trial failure increases the pressure to diversify into other disease areas outside of diabetes and obesity," said Markus Manns, a portfolio manager at Union Investment. The disappointing results led to a 7.3% drop in Novo's shares, which fell to 306.50 Danish crowns.
Analysts now view the chances of positive outcomes from two ongoing trials of ziltivekimab as "highly unlikely", raising concerns about Novo's future growth prospects. The company acquired ziltivekimab through a $725 million buyout of Corvidia Therapeutics in 2020, aiming to expand its portfolio beyond obesity and diabetes drugs like Wegovy and Ozempic.
Despite the setback, Novo stated that the trial outcome would not affect its 2026 profit outlook, although it will incur a non-cash impairment charge in Q3.
The failure of ziltivekimab also contributed to a broader slump in weight-loss drug stocks, with competitors like Eli Lilly experiencing declines as well.
"A large-sized deal in the CV/metabolic or rare disease space could help reignite investor interest," analysts from BMO Capital Markets suggested.
“Shares fell 7.3% to 306.50 Danish crowns, and BMO Capital Markets said a large-sized deal in CV/metabolic or rare disease space could help reignite investor interest. Novo expects a non-cash impairment charge in Q3 while keeping its 2026 adjusted operating profit outlook.”
STAT
