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SEP 29 2026
UPCOMING · 60 DAYS TO PDUFA

Novo Nordisk denecimig $NVO

for hemophilia A (with or without inhibitors) — prophylaxis

BLA · Standard Review

Accepted NOV 29 2025.

About

Hemophilia A is a genetic disorder where the blood cannot clot properly due to a lack of factor VIII, leading to a serious risk of spontaneous and injury-related bleeding. Denecimig is a bispecific antibody designed to act like the missing factor VIII, bridging two key clotting proteins to help form a stable clot. By mimicking this natural clotting function, the drug could potentially provide consistent protection against bleeding episodes.