The FDA has told Novo that its review of the biologics license application is still underway and has not given a new date for a decision.

  • Novo said the agency extended the review because remediation at the facility is still ongoing.
  • The company said the longer review does not change its 2026 financial outlook.
  • Novo’s rare blood-disorders sales were about DKK 12.0 billion in 2025, against group sales of DKK 309 billion.

Danish drugmaker Novo Nordisk (NVO) said on Friday that U.S. approval of its haemophilia A drug denecimig will slip past the third quarter because fixes at a manufacturing site are still underway. 

The FDA has told Novo that its review of the biologics license application is still underway and has not provided a new decision date. Novo filed the application in September 2025 for adults and children with haemophilia A, with or without inhibitors, and had expected a ruling in the third quarter of 2026.

A Plant Issue, Not A Clinical One, Says Novo

The delay follows a pre-license inspection of the manufacturing site. Novo said the agency extended the review because remediation at the facility is still ongoing. The company said it is already addressing the requests and working with the FDA on the remaining items. It also said the inspection feedback does not affect other marketed Novo products, and that the agency has not flagged deficiencies in the clinical efficacy or safety data in the filing.

Novo said the longer review does not change its 2026 financial outlook. It now aims to launch denecimig in the United States in the first half of 2027, pending a decision.

Novo’s rare blood-disorders sales were about DKK 12.0 billion in 2025, against group sales of DKK 309 billion. Obesity care alone was DKK 82 billion. Outside analysts have put denecimig’s peak sales near $2 billion a year. Roche’s Hemlibra, the drug it would have to take share from, did about $5.8 billion last year.

What The Drug Is Meant To Do

Denecimig is a bispecific antibody designed to mimic factor VIIIa, the clotting protein missing or defective in haemophilia A.  Novo is seeking approval for prophylaxis — treatment meant to prevent bleeds — on a monthly, every-two-week, or weekly schedule, including in patients who have developed inhibitors to standard factor replacement.

The filing rests on the FRONTIER program. FRONTIER2 tested weekly and monthly dosing in adults and adolescents 12 and older. FRONTIER3 did the same in children under 12. FRONTIER4, an open-label extension, looked at every-two-week dosing and longer-term safety across all three schedules. 

On Sept. 17, denecimig received a positive opinion from the European Medicines Agency’s human medicines committee and is now also awaiting a European Commission decision.

How Did NVO Retail Traders React?

On Stocktwits, retail sentiment around NVO stock stayed neutral over the past 24 hours, while message volume remained low. 

NVO stock has fallen 27% year-to-date. 

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