NVO: 6-K company filing

6-K 1 f6k_100226.htm FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________ FORM 6-K ________________ REPORT OF FOREIGN PRIVATE ISSUER Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 October 2, 2026 ________________ NOVO NORDISK A/S (Exact name of Registrant as specified in its charter) Novo Allé 1 DK- 2880, Bagsvaerd Denmark (Address of principal executive offices) ________________ Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F Form 20-F ☒ Form 40-F ☐ Novo provides update on the denecimig Biologics License Application (BLA) in the US • The US Food and Drug Administration (FDA) has informed Novo that the BLA review of denecimig for the treatment of haemophilia A is still ongoing. The FDA has not communicated a new timeline for regulatory action on the BLA • The FDA has informed Novo that the ongoing facility remediation activities are the cause for extension of the Agency's review. The FDA has not identified any deficiencies related to the clinical efficacy or safety data submitted in the denecimig BLA • Novo is actively working with the FDA, addressing the Agency's requests for remediations related to the manufacturing facility. The extended FDA review time for the denecimig BLA has no impact on Novo's financial outlook for 2026 and pending regulatory decision, Novo aims to launch denecimig in the US in the first half of 2027 Bagsværd, Denmark, 02 October 2026 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has informed Novo that the BLA review of denecimig for the treatment of haemophilia A, with or without inhibitors in adults and children, is still ongoing. The FDA has not communic