Also known as factor X, Stuart factor, and Stuart-Prower factor.
FDA review remains ongoing; extension caused by facility remediation, not clinical deficiencies. Novo still targets a US launch in H1 2027 and says 2026 outlook is unaffected.
First FVIIIa mimetic offering monthly, two‑week and weekly subcutaneous prophylaxis in a single‑use pre-filled pen; CHMP has issued a positive opinion for EU approval.
Phase 3b switch study shows denecimig well tolerated after direct switch from emicizumab; pen injector preferred and thrombin generation rose to normal without excess clotting.
Three researchers honoured for creating a bispecific antibody that mimics Factor VIII, enabling subcutaneous dosing and bleed prevention irrespective of inhibitors.