Novo Nordisk (NYSE: NVO) disclosed that the US FDA review of its Biologics License Application for denecimig (Frehemgo) remains ongoing because of manufacturing facility remediation, with no new regulatory action date communicated.
The FDA identified the issue following a pre-license inspection conducted after the BLA was submitted in September 2025. Novo said the agency has not identified deficiencies in the clinical efficacy or safety data supporting the application and that it is working to address the outstanding manufacturing requirements.
Denecimig is a subcutaneous FVIIIa-mimetic bispecific antibody that bridges factor IXa and factor X to restore thrombin generation in hemophilia A. In the pivotal Phase III FRONTIER2 trial, once-monthly treatment reduced treated bleeds by approximately 43% versus prior factor prophylaxis and nearly 99% versus on-demand treatment.
The drug is being reviewed for prophylaxis in adults and children with hemophilia A, with or without inhibitors. Emicizumab (Hemlibra) is the principal approved FVIIIa-mimetic competitor in the setting.