Basilea Pharmaceutica - Zevtera NDA submission pushed to Q323
Basilea 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 we believe a US launch date for Zevtera by late FY24 remains feasible.Basilea Pharmaceutica is an integrated biopharmaceutical company engaged in the discovery, development and commercialization of pharmaceutical products for the treatment of bacterial infections, fungal infections, oncology and skin diseases. Co. focuses on antibiotics and antifungals as well as oncology and dermatology drugs. Co.'s portfolio spans from innovative early-stage through clinical late-stage drug candidates to a marketed product. In the context of its international commercialization organization, Co. has subsidiaries in Denmark, France, Germany, Italy, Spain and the United Kingdom.
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