Full Breakdown
Novo Nordisk Halts Two Late-Stage Heart-Failure Trials of Ziltivekimab
9/7/2026, 9:33:16 PM
Core Event: Termination of the HERMES and ATHENA Studies
Novo Nordisk announced the premature termination of its Phase III HERMES (NCT05636176) and ATHENA (NCT06200207) trials on September 4. Both studies evaluated the interleukin-6 inhibitor ziltivekimab against placebo in patients with heart failure and systemic inflammation. A data-monitoring committee recommended stopping after an interim review concluded the drug was unlikely to meet its primary endpoints, echoing the earlier failure of the ZEUS Phase III trial.
Background & Context
Ziltivekimab, a once-monthly subcutaneous IL-6 inhibitor, was acquired by Novo Nordisk in 2020 for $725 million. The compound was intended to broaden Novo’s pipeline beyond diabetes, obesity and rare-disease franchises by targeting inflammation-driven cardiovascular risk. The ZEUS trial in patients with atherosclerotic cardiovascular disease and chronic kidney disease failed in July 2026 to reduce major adverse cardiovascular events (MACE) despite lowering inflammatory biomarkers. HERMES and ATHENA were designed to test whether dampening inflammation could improve outcomes such as cardiovascular death, heart-failure hospitalisations, urgent visits, and quality of life in heart-failure patients with preserved or mildly reduced ejection fraction.
Data & Statistics
- Trial identifiers: HERMES (NCT05636176) and ATHENA (NCT06200207).
- Primary focus: Time to first cardiovascular death or heart-failure-related hospitalisation (HERMES); quality-of-life and related heart-failure metrics (ATHENA).
- ZEUS outcome: No reduction in MACE; inflammatory markers lowered.
- Stock reaction (Sept 7, 2026): Shares at 298.62 DKK, a 0.09 % dip from 298.90 DKK; YTD up ~2.21 %, still ~8.12 % below the year-start high.
- Analyst target: Average price target 309.73 DKK, implying ~3.6 % upside.
Official Statements & Responses
Novo Nordisk informed investigators on September 4 that the DMC had advised ending both trials. A company spokesperson said the decision was based on the committee’s assessment that the totality of data made a positive outcome unlikely, consistent with the ZEUS experience. All participants will continue to be followed through their scheduled three-month visits. Novo also confirmed that the Phase III ARTEMIS trial, which evaluates ziltivekimab as an acute post-myocardial-infarction therapy, will proceed as planned, with a readout anticipated in the first half of 2027.
Market Reaction
The modest share-price decline reflected investors weighing the negative cardiovascular data against encouraging pediatric obesity results. Commentary noted that Novo’s valuation remains anchored to its GLP-1-based obesity and diabetes portfolio, while diversification into new cardiovascular indications is uncertain. Analysts said that, given the current price sits only a few percent below consensus targets, significant upside would likely require fresh pipeline catalysts.
What’s Next
- ARTEMIS trial: Data readout scheduled for the first half of 2027.
- Follow-up visits: Patients from the halted HERMES and ATHENA studies will complete their three-month assessments as planned.
- Pipeline diversification: Novo Nordisk may explore additional licensing or acquisition opportunities to bolster its cardiovascular portfolio, though any such moves will be evaluated against recent trial setbacks.
