An FDA decision on Novo Nordisk's experimental hemophilia A treatment denecimig will not come on schedule because of problems at a manufacturing facility, not because of concerns about the drug's clinical results. Novo said in a statement on the status of the denecimig biologics license application on Oct. 2 that the FDA's review remains ongoing while a manufacturing site completes remediation following an FDA pre-license inspection.
Novo submitted its application in September 2025 and had expected a decision in the third quarter of 2026, a target that has now passed. The FDA has not communicated a new timeline, and Novo now aims to launch denecimig in the U.S. in the first half of 2027, if approved.
