FDA places clinical hold on BiomX Phase 2b study of BX004 in cystic fibrosis over a third-party nebulizer

In a Form 8-K dated August 19, 2025, BiomX reported that the FDA placed a clinical hold on its Phase 2b study of BX004 in cystic fibrosis while it reviews data on a third-party nebulizer used to deliver BX004. The FDA raised no concerns about BX004 in the hold notification and BiomX submitted the additional data requested; patient screening and enrollment in the US portion are paused, while in Europe, where all nebulizer components are CE marked, the study has been approved and enrollment and dosing continue.