Novo Nordisk said the U.S. Food and Drug Administration extended its review of the Biologics License Application for denecimig, a haemophilia A treatment, due to ongoing remediation at a manufacturing facility.
The company originally expected an FDA decision in the third quarter of 2026. It now targets a U.S. launch in the first half of 2027, pending approval.
The FDA identified no deficiencies in denecimig's clinical efficacy or safety data during its pre-license inspection. The manufacturing feedback does not affect other Novo Nordisk marketed products, the company said.
Novo Nordisk submitted the BLA in September 2025. The application covers patients with and without inhibitors.
Separately, denecimig received a positive opinion from a European regulatory committee on Sept. 17, with final EU marketing approval still pending.
The delay creates a material headwind for Novo Nordisk's haemophilia franchise and pushes meaningful revenue contribution into 2027 at the earliest. Investors should monitor manufacturing remediation timelines closely—any further delays risk pushing launch into H2 2027, substantially denting near-term upside to consensus estimates.
