The FDA (U.S. drug regulator) told Novo Nordisk that its BLA (biologics license application) review of denecimig for hemophilia A remains ongoing because of facility remediation activities. The agency has not provided a new timeline for regulatory action and has identified no deficiencies in denecimig’s clinical efficacy or safety data from the FRONTIER program. Novo said the extended review does not change its 2026 financial outlook and that, pending a regulatory decision, it aims to launch denecimig in the United States in the first half of 2027. The company is working with the FDA to complete manufacturing-site remediation.