Despite the regulatory delay, Novo is still expecting a 2027 launch for its hemophilia A drug denecimig.
The FDA needs more time to review Novo’s investigational bispecific antibody for hemophilia A before making an approval decision, citing manufacturing issues as the reason behind the delay.
The agency said “ongoing facility remediation activities” were the reason for the extension, according to a release from Novo. The FDA did not identify any deficiencies related to the efficacy or safety of the drug, known as denecimig, according to the Danish pharma.
Novo submitted the next-gen factor VIII mimetic for FDA review in September 2025, with a decision slated for the third quarter of this year. Novo announced the agency’s delay on the second day of the fourth quarter.
The FDA has yet to share a new timeline for the review, according to Novo, which is working to address the agency’s remediation requests related to the unnamed manufacturing site.
The FDA’s manufacturing flag does not impact other marketed Novo products, the pharma said. Novo is still banking on FDA approval, saying the company is still preparing for a 2027 denecimig launch for hemophilia A in adults and children.
“Novo is already in the process of addressing the FDA’s requests as efficiently as possible and continuing to work closely with the Agency toward bringing denecimig to patients in the US,” Novo CEO Mike Doustdar said in a prepared statement.
The extended FDA review for denecimig “has no impact on Novo’s financial outlook for 2026,” according to the company. Analysts with BMO Capital Markets listed the denecimig decision as one of seven key catalysts for Novo, deeming it of “medium” importance in a Sept. 9 report.
Novo has been testing denecimig as a prophylactic treatment to prevent bleeding episodes for hemophilia A, a genetic bleeding disorder. The program is also currently being evaluated for potential approval by European regulators.
Novo has faced other manufacturing challenges of late, stemming from Novo Holdings’ $16.5 billion buy Catalent, a contract development and manufacturing organization (CDMO) in 2024. It then sold three of Catalent’s fill-finish sites to the pharma company then called Novo Nordisk to help meet demand for its GLP-1 injectables Ozempic and Wegovy. Novo also inherited customers that Catalent made products for.
Earlier this year, quality problems at the ex-Catalent fill-finish facility in Indiana prompted Scholar Rock, an affected client, to drop the plant from its application for approval of apitegromab, a candidate to treat spinal muscular atrophy. The FDA had designated the plant with an Official Action Indicated (OAI) classification, which indicates recommended regulatory or administrative actions in response to an unacceptable state of compliance.
After dropping the plant from its filing, Scholar Rock secured FDA approval, with apitegromab now to be sold as Isembyld.
