Novo Nordisk stock news
On October 5, 2026, the U.S. Food and Drug Administration (FDA) extended its review of Novo Nordisk's Biologics License Application (BLA) for denecimig, a treatment under development for haemophilia A in adult and paediatric patients. The extension is due to ongoing facility remediation activities resulting from an FDA pre--license manufacturing site inspection, with no deficiencies cited regarding clinical efficacy or safety data from the FRONTIER clinical trial program. Novo Nordisk affirmed that the review extension will not affect its 2026 financial outlook and maintained its target to launch denecimig in the United States in the first half of 2027, subject to regulatory approval.