Novo Nordisk says phase 3 data show denecimig cuts bleeding rates in hemophilia A extension study

• Novo Nordisk unveiled interim phase 3 FRONTIER4 extension data supporting denecimig (Mim8) safety and efficacy in hemophilia A prophylaxis.
• Denecimig is under FDA review following a September 2025 Biologics License Application filing.
• Study safety profile stayed consistent; injection-site reactions were 1.8%-2% of injections; no neutralizing antibodies were observed.
• Estimated mean annualized bleeding rates were 0.75 in adults/adolescents, 0.37 in children; 71% and 89% had zero treated bleeds.

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