BiomX Inc. announced on August 19, 2025, that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the U.S. portion of its Phase 2b trial for BX004 in cystic fibrosis patients. The FDA's notification focused solely on queries regarding a third-party nebulizer device used for drug delivery, not the BX004 drug candidate itself.
Following the FDA's notification, patient screening and enrollment in the U.S. portion of the trial have been paused. BiomX has promptly submitted the additional requested data, which was generated independently by the nebulizer device's manufacturer, and remains optimistic for a swift resolution.
Enrollment and dosing of patients outside the U.S. are continuing in Europe, where all components of the third-party nebulizer device are CE marked and meet applicable regulatory requirements. BiomX stated its commitment to providing timely updates as the situation develops.
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