Novo Nordisk (NYSE:NVO) said the US Food and Drug Administration has extended its review of denecimig, the company’s treatment for haemophilia A, due to ongoing remediation activities at its manufacturing facility.
The company submitted a Biologics License Application for denecimig in September 2025 for the treatment of adults and children with haemophilia A, with or without inhibitors.
Novo Nordisk had previously expected a regulatory decision during the third quarter of 2026. The FDA has not provided a revised timeline for its decision.
FDA Review Extension Linked to Manufacturing Facility
The FDA conducted a pre-license inspection of the manufacturing site following the application and subsequently provided feedback to Novo Nordisk.
According to the company, the regulator said ongoing remediation work at the facility was the reason for extending the review.
Novo Nordisk said the FDA has not identified deficiencies related to the clinical efficacy or safety data from the FRONTIER clinical trial programme.
The feedback concerning the manufacturing facility also does not affect Novo Nordisk products that are already marketed.
Mike Doustdar, president and chief executive 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 Targets First-Half 2027 US Launch
Novo Nordisk said the extended FDA review does not affect its financial outlook for 2026.
Subject to receiving regulatory approval, the company is targeting a US launch of denecimig during the first half of 2027.