NVO ▼ -0.6% - Novo Nordisk A/S $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. 02-OCT-2026 05:01 PM ET