Novo Nordisk halts two ziltivekimab heart-failure trials as shares slip

Novo Nordisk's US-listed shares fell nearly 2% to about $46.60 after the Danish drugmaker stopped two Phase 3 trials of its experimental heart-failure drug ziltivekimab, a pipeline setback that outweighed a positive pediatric result for semaglutide reported around the same time ^[1].

Novo told investigators on September 4 that the HERMES and ATHENA studies would end early ^[1]. The decision followed a review by an independent data monitoring committee, which concluded that neither trial was likely to produce a result different from the ZEUS study, which missed its main goal in July ^[1]. HERMES had been testing ziltivekimab against placebo on the time to a first cardiovascular death or a heart-failure-related hospitalization or urgent visit. ATHENA looked at quality-of-life measures in the same group of patients, who had heart failure and inflammation ^[1]. Patients in the stopped trials will complete their scheduled three-month follow-up visits ^[1].

Ziltivekimab is an anti-inflammatory medicine that targets IL-6. It is not a GLP-1 drug. Novo acquired it through a $725 million upfront takeover of Corvidia Therapeutics in 2020 ^[1]. Three of the four Phase 3 cardiovascular studies of ziltivekimab are now failed or stopped. The remaining one, ARTEMIS, tests the drug in people who have just had a heart attack, and its data are expected in the first half of 2027 ^[1][2].

The pediatric result came from STEP Young, a Phase 3 trial of semaglutide in 165 children aged 6 to under 12 ^[1]. After 68 weeks, 40.4% of the children taking semaglutide no longer met the definition of obesity, compared with zero children on placebo in a full-adherence analysis ^[1]. More than 85% of the children started the trial with severe obesity, and all participants received diet and exercise support ^[1]. Novo reported no new safety concerns related to growth or puberty ^[1]. Whether regulators will approve semaglutide for this age group has not been reported.

Financially, Novo reported second-quarter adjusted operating profit of DKK 33.39 billion, about $5.2 billion, on revenue of DKK 78.49 billion, about $12.2 billion, a 42.5% margin ^[1]. The US-listed shares sit 55.98% below a GF Value estimate of $105.85 cited in one report ^[1]. European-listed shares traded at €38.73, roughly 29% below their 52-week high of €54.86 and down 12% for the year ^[2].

Citi analysts reaffirmed a sell rating in early September with a price target of DKK 265, pointing to an IQVIA tracker that shows slower growth in new GLP-1 prescriptions, with oral Wegovy as a notable exception ^[2]. Oral Wegovy has been on sale in Germany since early September, and China has started an approval review with no timeline given ^[2]. The FDA has approved Mounjaro to reduce cardiovascular risk in high-risk type 2 diabetes patients ^[2]. Under agreed US price cuts, Ozempic and Wegovy will cost $350 per month through the TrumpRx channel ^[2].

Why it matters for patients

The halted trials involved ziltivekimab, an experimental anti-inflammatory medicine, not semaglutide. Nothing reported here changes the approved uses of Ozempic, Wegovy or Rybelsus, the brand names for semaglutide, or of tirzepatide products such as Mounjaro and Zepbound ^[1][2].

For adults who take a GLP-1, the items with the most direct bearing on daily life are the business ones: an agreed $350 monthly US price for Ozempic and Wegovy through the TrumpRx channel, and an analyst tracker showing slower growth in new prescriptions, with the oral Wegovy tablet as an exception ^[2]. Whether either shifts what people actually pay or can get filled has not been reported.

The pediatric data concern children aged 6 to under 12, a group for which semaglutide approval has not been reported. The trial measured 68 weeks of treatment alongside diet and exercise support, and results on weight maintenance after treatment stops are not yet known ^[1].

Novo's 42.5% second-quarter margin gives it room to absorb the ziltivekimab setback, but the company has faced months of market questions about whether its pipeline beyond weight loss and diabetes can deliver ^[1][2].

What happens next

Novo Nordisk has scheduled a capital markets day for September 21, which Reuters reported, and the company is expected to face questions there about how it plans to fill the gap left by the heart-failure program ^[2]. Results from ARTEMIS, the remaining ziltivekimab heart study, are expected in the first half of 2027 ^[1][2]. No date for a regulatory filing or decision on semaglutide in children aged 6 to under 12 has been reported ^[1][2].