FDA delays review of Novo Nordisk's denecimig

The U.S. Food and Drug Administration notified Novo Nordisk that the review of its biologics license application for denecimig remains ongoing, with no new action date provided. The delay stems from remediation activities at a manufacturing facility following a pre-license inspection. The agency identified no deficiencies in the therapy's clinical efficacy or safety data.

Novo Nordisk submitted the application in September 2025 seeking approval for adults and children with hemophilia A, initially expecting a decision in the third quarter of 2026. Denecimig is an investigational FVIIIa-mimetic bispecific antibody designed for once-monthly, every-two-weeks, and weekly subcutaneous dosing. The submission drew on the FRONTIER clinical program, including the phase III FRONTIER2, FRONTIER3, and open-label extension FRONTIER4 studies.

The company stated that the factory feedback does not affect its other marketed products or its 2026 financial outlook. Novo Nordisk continues to aim for a U.S. launch in the first half of 2027, subject to regulatory approval. In Europe, the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending approval in September 2026, with a final European Commission decision pending.

Year to date, Novo Nordisk shares have dropped 26.6%, while the broader industry gained 9.5%.