Novo says FDA review of denecimig is still ongoing

Novo Nordisk said on 2 October 2026 that the US Food and Drug Administration has told it the review of denecimig, its biologics license application for haemophilia A, is still under way. The agency has not given a new timeline for regulatory action, and the company said the extended review time does not affect its financial outlook for 2026.

For retail investors watching Novo, the immediate point is that the delay is tied to manufacturing-site remediation, not to the clinical data package. The FDA said the ongoing facility remediation activities are the reason for the extension, while not identifying deficiencies in the efficacy or safety data from the FRONTIER clinical trial programme.

Novo said it is working with the FDA on the requested remediations for the manufacturing facility, and that the feedback on the site does not affect other marketed Novo products. It also said that, pending a regulatory decision, it aims to launch denecimig in the US in the first half of 2027.

The company had submitted the BLA in September 2025 and had been expecting a regulatory decision in the third quarter of 2026. Novo’s president and chief executive, Mike Doustdar, said: “Haemophilia A patients should expect more from their standard of care.” He added that Novo was already 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.