Novo Nordisk BLA Update: US FDA Review Ongoing
Novo Nordisk announced that the US Food and Drug Administration (FDA) has informed the company that the review of the Biologics License Application (BLA) for denecimig, a treatment for haemophilia A, is still ongoing. The FDA has not yet communicated a specific timeline for the completion of the review.
Story updates
08:58:28 PM UTC
SquawkNews
Novo Nordisk said the FDA’s review of denecimig for haemophilia A is extended due to ongoing facility remediation. The Agency gave no new action date and cited no clinical data deficiencies. Novo still targets a US launch in H1 2027 and maintained 2026 outlook.Material DetailsContext by AI AnalystT…
09:01:00 PM UTC
SquawkNews
NVO Novo Nordisk: FDA Review of Denecimig BLA Extended Due to Manufacturing Facility Remediation ⠀ · FDA has not identified deficiencies in submitted clinical efficacy or safety data and has not provided a new decision timeline. · Novo says the delay does not affect its 2026 financial outlook and still targets a U.S. launch in H1 2027, pending approval. · Denecimig also received a positive CHMP opinion on Sept. 17, with European marketing approval still pending.