Presents phase III FRONTIER4 interim data for denecimig in hemophilia A; 71% of adults/adolescents and 89% of children had zero treated bleeds
- FRONTIER4 included 426 participants aged 1 and older across once-weekly, once-every-two-weeks and once-monthly dosing; estimated mean annualized bleeding rates were 0.75 in adults/adolescents and 0.37 in children.
- Injection-site reactions occurred in 2.0% of injections in children and 1.8% in adolescents/adults; all were mild and transient, with no clinical evidence of neutralizing antibodies.
- Denecimig was submitted to the FDA through a Biologics License Application in September 2025.
- Phase 3 explorer10 data in 24 children under 12 with hemophilia A or B and inhibitors showed concizumab reduced annualized bleeding rate 82% versus prior on-demand treatment, to 2.08 from 11.51.