As reported on BioSpace, the FDA has extended its review of Novo’s investigational hemophilia A therapy denecimig due to manufacturing-related concerns, although the company says the regulatory setback has not changed its plans for a potential US launch in 2027.
According to Novo, the delay is tied to remediation work underway at a manufacturing facility rather than concerns about denecimig’s clinical profile. The company said the FDA has not raised deficiencies involving the therapy’s safety or efficacy.
Denecimig is a next-generation factor VIII-mimetic bispecific antibody being developed as a prophylactic treatment to prevent bleeding episodes in people with hemophilia A. Novo submitted the therapy for FDA review in September 2025 and had previously anticipated a regulatory decision during the third quarter of 2026.
The agency has not provided Novo with an updated timetable for completing its review. In the meantime, the drugmaker said it is addressing the FDA’s requests concerning the manufacturing site and working with regulators to advance the application.
Despite the extension, Novo continues to prepare for a 2027 US launch of denecimig for both adults and children with hemophilia A. The company also said the delay does not alter its financial outlook for 2026. Denecimig is additionally under regulatory review in Europe.
Manufacturing Scrutiny Comes Amid Broader Challenges
The setback follows other manufacturing-related issues involving facilities connected to Novo.
In 2024, Novo Holdings acquired contract development and manufacturing organization Catalent for $16.5 billion. Three Catalent fill-finish facilities were subsequently sold to the pharmaceutical business then known as Novo Nordisk as part of efforts to expand production capacity for injectable GLP-1 medicines, including Ozempic and Wegovy.
Quality concerns at a former Catalent site in Indiana also affected another drug developer. Scholar Rock removed the facility from the manufacturing network included in its application for apitegromab, a treatment for spinal muscular atrophy, after the FDA classified the plant as Official Action Indicated. That designation signals that regulators may pursue administrative or regulatory measures because of unacceptable compliance conditions.
Scholar Rock subsequently obtained FDA approval for apitegromab, which is marketed as Isembyld.
For denecimig, however, Novo maintains that the manufacturing matter does not affect its other marketed products and says it remains focused on resolving the FDA’s outstanding requests while moving the hemophilia A program toward potential approval.
