Novo Nordisk (NYSE: NVO) said the U.S. Food and Drug Administration has extended its review of denecimig, a treatment for haemophilia A, due to ongoing facility remediation activities at the company's manufacturing site.

Novo Nordisk submitted a Biologics License Application (BLA) for denecimig in September 2025, targeting adults and children with haemophilia A, with or without inhibitors. The company had anticipated a regulatory decision in the third quarter of 2026. The FDA has not provided a new timeline for its regulatory action.

The FDA conducted a pre-license inspection of the manufacturing site following the BLA submission and provided feedback. The agency stated that ongoing facility remediation activities are the reason for the extended review. The FDA has not identified deficiencies related to the clinical efficacy or safety data from the FRONTIER clinical trial program. The manufacturing site feedback does not affect other marketed Novo Nordisk products.

Mike Doustdar, president and CEO of Novo Nordisk, said the company "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."

Novo Nordisk said the extended review period does not affect its financial outlook for 2026. Pending a regulatory decision, the company aims to launch denecimig in the U.S. in the first half of 2027.