denecimig (Mim8) - (FRONTIER4)

July 11, 2026: Novo Nordisk presented new phase 3 data at the ISTH 2026 Congress (Paris) for its hemophilia portfolio.

Denecimig (Mim8) – FRONTIER4 phase 3 long-term extension (hemophilia A, with/without inhibitors; all ages): Interim open-label data from 426 participants (365 adults/adolescents; 61 children) showed safety consistent with prior FRONTIER studies. Injection-site reactions were low (2.0% of injections in children; 1.8% in adults/adolescents), mild and transient, and no clinical evidence of neutralizing antibodies was observed. Efficacy was maintained across once-weekly, once-every-two-weeks, and once-monthly regimens: estimated mean ABR 0.75 (adults/adolescents; 95% CI 0.60–0.93) and 0.37 (children; 95% CI 0.17–0.76). Zero treated bleeds occurred in ~71% of adults/adolescents and 89% of children. Exploratory PROs suggested sustained improvements in joint pain (≥12 years) and reduced treatment burden; most users rated the pen-injector easy and quick to use. Post hoc analyses (FRONTIER2/5) found thrombin generation increased into the normal reference range without excessive response. Novo Nordisk noted denecimig is under FDA review; a BLA was submitted in September 2025.

Concizumab – explorer10 phase 3 (children <12 with hemophilia A or B with inhibitors): In 24 children, estimated mean ABR on prophylaxis was 2.08 vs 11.51 on prior on-demand therapy (ABR ratio 0.18; 82% reduction). Adverse events occurred in 83% (mostly mild); serious AEs in 29%; injection-site reactions were infrequent (0.1 events per patient-year).