Basilea Pharmaceutica - Zevtera back on track: NDA submitted to the FDA
Basilea has announced that it has filed its new drug application (NDA) for Zevtera (ceftobiprole) with the FDA. As part of this submission, the company is seeking approval for three indications: Staphylococcus aureus bacteraemia (SAB), acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). We note that the NDA is eligible for priority review and, hence, Basilea expects a regulatory decision on the approval of Zevtera in the US by Q224, potentially representing a significant catalyst for the company.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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