Novo submitted the application in September 2025 and had expected a decision in the third quarter of 2026. Following a pre-license inspection of the manufacturing site, the FDA has now told the company that facility remediation is the reason for the extended review. The agency has not identified deficiencies in the clinical efficacy or safety data from the FRONTIER programme, and Novo says the site feedback does not affect its other marketed products.

The delay has no impact on Novo’s 2026 financial outlook, and the company aims to launch denecimig in the US in the first half of 2027, pending approval. Denecimig, a once-monthly, every-two-weeks or weekly subcutaneous FVIIIa-mimetic bispecific antibody, received a positive CHMP opinion in the EU on 17 September.

“Novo is already in the process of addressing the FDA’s requests as efficiently as possible and continuing to work closely with the Agency toward bringing denecimig to patients in the US,” says Mike Doustdar, President and CEO, Novo.