Mim8 - (FRONTIER5)

October 2, 2026: Novo Nordisk (Nasdaq Copenhagen: Novo-B; NYSE: NVO) said the FDA review of the denecimig BLA for haemophilia A in adults and children, with or without inhibitors, remains ongoing, and the agency has not provided a new timeline for regulatory action. Novo had submitted the BLA in September 2025 with an expected decision in Q3 2026.

According to Novo, the review extension is due to ongoing remediation at the manufacturing facility identified during the FDA pre-license inspection. The FDA has not identified deficiencies in the clinical efficacy or safety data submitted in the BLA, which were generated in the FRONTIER programme.

Novo said it is addressing the FDA’s manufacturing-related requests and working with the agency on outstanding requirements. The company said the delay does not affect its 2026 financial outlook and, pending approval, it still aims to launch denecimig in the US in H1 2027.

Separately, denecimig received a positive CHMP opinion on September 17 and is pending EMA marketing approval. FRONTIER2, FRONTIER3, and FRONTIER4 supported the MAA submission.