Novo Nordisk to present denecimig and concizumab data at ISTH 2026
- New data will be presented at the ISTH Congress, 11–15 July 2026 in Paris.
- FRONTIER4 phase‑3 interim analyses evaluate denecimig (Mim8) long‑term efficacy and safety across adults, adolescents and children with haemophilia A, with or without inhibitors, across once‑monthly, once‑every‑two‑weeks and once‑weekly prophylaxis.
- Explorer10 open‑label phase‑3 study reports concizumab (Alhemo®) efficacy, safety and PK/PD for paediatric participants up to 11 years with haemophilia A/B and inhibitors at a 32‑week cut‑off.
- Denecimig is an investigational FVIIIa‑mimetic and Novo Nordisk submitted a BLA to the US FDA in September 2025; concizumab use in children under 12 remains investigational and is not approved anywhere.
Event and scope
Novo Nordisk will present a programme of oral and poster presentations at the 34th ISTH Congress in Paris, 11–15 July 2026, covering clinical, real‑world and patient‑reported outcomes across its haemophilia portfolio.
Denecimig (Mim8) — FRONTIER4 and related analyses
Multiple interim analyses from the phase‑3 FRONTIER4 long‑term safety and efficacy study will be shared, including results in adults, adolescents and children with haemophilia A, with or without inhibitors. Presentations cover varying prophylaxis schedules (once‑monthly, once‑every‑two‑weeks and once‑weekly), patient‑reported outcomes, thrombin generation post‑hoc analyses referencing FRONTIER2 and FRONTIER5, tiered dosing exposure and mechanistic in‑vitro data across von Willebrand disease and warfarin co‑presence. A multinational open‑label study in adults with acquired haemophilia A is noted with enrolment in 2026.
Concizumab (Alhemo®) — explorer10 paediatric data
First data from the open‑label phase‑3 explorer10 study evaluate concizumab in children up to 11 years with haemophilia A or B and inhibitors, reporting efficacy, safety and PK/PD at a 32‑week cut‑off. The release reiterates that concizumab use in children under 12 is investigational and not approved.
Additional analyses
Abstracts also include preclinical and real‑world studies on activity‑related bleeds via a microhealth app, physicians’ treatment preferences and US indirect cost burden and patient‑reported outcomes analyses.
Source: Novo Nordisk
