Novo Nordisk received notice from the Food and Drug Administration that its review of denecimig for the treatment of hemophilia A is still ongoing.

The FDA hasn't communicated a new timeline for expected regulatory action on the biologics license application, the drug company said Friday.

The cause for the extension of the agency's review is ongoing remediation activities at Novo's manufacturing facility. The FDA performed a pre-license inspection of the site and provided feedback after the company first submitted its license application.

Novo submitted the application to the FDA in September 2025 for denecimig as a treatment of hemophilia A in adult and pediatric patients. At that time, it was anticipating a regulatory decision in the third quarter of 2026.

The FDA hasn't identified deficiencies related to the clinical efficacy or safety data of the drug, Novo said. The company is continuing implementation of the facility remediation activities in response to the FDA's feedback.

The prolonged review time doesn't impact Novo's financial outlook for 2026. Pending a decision, Novo aims to launch denecimig in the U.S. in the first half of 2027.