The FDA has delayed Novo’s review of denecimig, a hemophilia A injection, citing facility issues discovered during a pre-license inspection. The agency extended its timeline because of ongoing remediation activities at an unnamed manufacturing site. The move highlights how CMC problems can translate into schedule risk even after a clinical dataset is ready for regulator scrutiny. While the FDA did not disclose details of the remediation actions, the phrasing signals active corrective work rather than a completed resolution. For the manufacturer, the immediate impact is timeline uncertainty; for the market, the broader point is that supply-chain and facility readiness remain gating items that can slow rare disease treatment availability.