Novo Nordisk's denecimig, a hemophilia A treatment, faces an ongoing U.S. FDA review. The delay stems from unresolved manufacturing facility requirements. Novo Nordisk had anticipated an FDA decision in the third quarter of 2026. The FDA has not provided a new timeline.
The FDA has not identified deficiencies in denecimig's clinical efficacy or safety data. Novo Nordisk is actively addressing the manufacturing issues. The company states this delay does not impact its 2026 financial guidance. Novo Nordisk aims for a U.S. launch in the first half of 2027, contingent on regulatory approval.