FDA extends review of Novo’s hemophilia A drug, citing manufacturing issues

The FDA has extended its review of Novo's denecimig, an investigational bispecific antibody and next-gen factor VIII mimetic for prophylactic treatment of hemophilia A, citing ongoing facility remediation activities at an unnamed manufacturing site. The agency flagged no efficacy or safety deficiencies, and Novo, which submitted the drug in September 2025 with a decision originally slated for the third quarter, says it is addressing the FDA's requests and still preparing for a 2027 launch in adults and children. The FDA has not shared a new review timeline, and European regulators are also evaluating the programme.