Novo Nordisk announced positive results from the phase 3 FRONTIER4 extension study for denecimig (Mim8).
The data, presented at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress, confirmed long-term safety and efficacy for the subcutaneous prophylactic treatment.
The study included children, adolescents, and adults, demonstrating effectiveness regardless of inhibitor status.
Researchers evaluated multiple dosing frequencies, including once-weekly, once-every-two-weeks, and once-monthly schedules.
Denecimig is an investigational antibody designed to mimic the function of Factor VIII.
The treatment is currently under review with the US Food and Drug Administration (FDA).