Novo Nordisk announced encouraging interim results from its phase 3 FRONTIER 4 long-term extension study at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress. The data demonstrate the sustained safety and efficacy of investigational denecimig (Mim8) prophylaxis administered weekly, bi-weekly, or monthly in people with hemophilia A.
The trial evaluated 426 participants aged one year and older. Efficacy results showed remarkably low annualized bleeding rates (ABRs) across all dosing regimens, regardless of inhibitor status. Crucially, 71% of adults and adolescents, alongside 89% of children, achieved zero treated bleeds while receiving denecimig. The primary safety endpoint aligned with prior trials, showing low rates of mild, transient injection-site reactions and no clinical evidence of neutralizing antibodies. Exploratory patient outcomes also noted significantly reduced treatment burden. Denecimig is currently under review with the US Food and Drug Administration (FDA).
Additionally, Novo Nordisk presented first-time data from the explorer10 trial. Concizumab prophylaxis delivered an 82% reduction in ABR compared to prior on-demand therapies in children under 12 with hemophilia A or B with inhibitors.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
