Also known as factor IIa.
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.
Interim FRONTIER4 data show consistent safety and efficacy of denecimig across weekly, biweekly and monthly dosing, with low injection-site reactions and high zero-bleed rates.
