FDA extends review of denecimig haemophilia A BLA over manufacturing remediation

The FDA is still reviewing Novo's biologics license application for denecimig, a haemophilia A treatment, and has set no new decision date. Novo had expected a decision in Q3 2026. The FDA attributes the delay to remediation at the manufacturing facility and has identified no deficiencies in the clinical efficacy or safety data. Novo still targets a US launch in the first half of 2027 and says the delay does not affect its 2026 outlook.

• Company announcement No 59/2026, published 2 October 2026
• Previously expected FDA decision in Q3 2026; no new timeline set
• Cause: facility remediation following a pre-license inspection
• No deficiencies identified in efficacy or safety data
• US launch targeted for the first half of 2027; 2026 outlook unaffected