NVO: 6-K company filing

6-K 1 f6k_091726.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 September 17, 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 ☐ CHMP recommends EU approval of FREHEMGO® (denecimig), the first factor VIIIa mimetic offering monthly, once every two weeks and weekly dosing in a pre-filled pen, for the treatment of haemophilia A · FREHEMGO® (denecimig) has been recommended by CHMP for approval in the EU for the treatment of haemophilia A (congenital FVIII deficiency), with or without inhibitors for adults and children · FREHEMGO® is the first FVIIIa mimetic to offer once-monthly, once-every-two-weeks and once-weekly prophylaxis in a single-use pre-filled pen · Novo expects to launch FREHEMGO® in the first European countries in Q4 2026 and broadly across the EU starting early 2027 Bagsværd, Denmark, 17 September 2026 – Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation for FREHEMGO® (denecimig) to treat haemophilia A (HA), with or without inhibitors, in adults and children. FREHEMGO® is a next-generation factor VIIIa mimetic bispecific antibody, designed as a routine prophylaxis to prevent or reduce the fr