Novo Nordisk said the U.S. Food and Drug Administration (FDA) has extended its review of the Biologics License Application (BLA) for denecimig, a treatment for haemophilia A. The delay stems from ongoing remediation at a manufacturing facility, identified during a pre-license inspection.
The FDA had been expected to make a decision in the third quarter of 2026 but has not provided a new timeline. Novo Nordisk said the FDA has found no deficiencies related to denecimig’s clinical efficacy or safety data.
The extended review does not affect Novo Nordisk’s 2026 financial outlook or its other currently marketed products. Pending regulatory approval, the company still aims to launch denecimig in the U.S. in the first half of 2027.