Novo Nordisk presented long-term data for its investigational hemophilia A treatment, denecimig (Mim8), at the ISTH 2026 Congress.
Interim results from the Phase 3 FRONTIER4 extension study confirmed sustained safety and efficacy for adults, adolescents, and children. The drug maintained a consistent safety profile across weekly, bi-weekly, and monthly subcutaneous dosing frequencies.
Clinical data showed 71% of adults and adolescents experienced zero treated bleeds. Among pediatric participants, 89% achieved zero treated bleeds.
These findings support the drug's use for patients with or without inhibitors. The results reinforce the Biologics License Application currently under review by the FDA.