Basilea Pharmaceutica - Zevtera (ceftobiprole) clinical data published

Basilea has announced that the results from its Phase III trial (ERADICATE) for ceftobiprole have been published the New England Journal of Medicine, a high-impact peer-reviewed medical journal. While these trial results were first shared in July 2022, we believe that the publication highlights positive data from the study as management awaits a regulatory decision on US approval. Basilea filed its new drug application (NDA) with the FDA for ceftobiprole in August 2023, and the ERADICATE study evaluated its application for Staphylococcus aureus bacteraemia (SAB), one of the three indications Basilea is seeking approval for. Management expects a decision from the FDA by Q224, potentially representing a significant catalyst for the company.