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.