Novo says FDA review of denecimig is still ongoing

Novo Nordisk said the US Food and Drug Administration has told it that the biologics license application review for denecimig, its haemophilia A treatment, is still ongoing and that no new timeline has been given for regulatory action. The company said the agency linked the longer review to ongoing remediation work at the manufacturing facility.

For traders and newer investors following Novo, the key point is that the delay is tied to the plant rather than to the clinical package. Novo said the FDA has not identified any deficiencies in the efficacy or safety data submitted with the application, including data from the FRONTIER clinical programme.

Novo said it is working with the FDA on the requested remediations and that the extra review time has no impact on its financial outlook for 2026. Pending a regulatory decision, the company still aims to launch denecimig in the US in the first half of 2027.

The application was submitted in September 2025, with an anticipated regulatory decision in the third quarter of 2026. Novo also said the manufacturing-site feedback does not affect other marketed Novo products.