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Zevtera NDA Submission Pushed to Q323

Basilea Pharmaceutica has announced that there will be a minor delay in the timing of its new drug application (NDA) for Zevtera (ceftobiprole) to the FDA and it now anticipates submission in Q323 (previously H123). The decision comes because one of Basilea’s contract manufacturing organisations requires an additional three to six months to adapt its quality control systems before FDA inspection, a prerequisite for NDA review. Following the NDA submission, Basilea expects a regulatory decision on the approval of Zevtera in the United States by Q224. Management does not expect the recent news to affect its FY23 financial guidance and Edison Group believes that a US launch date for Zevtera by late FY24 remains feasible.  Edison notes that if Zevtera is approved by the FDA, the QIDP designation would allow it up to 10 years of market exclusivity in the US.

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