BiomX Inc. is working with a third-party manufacturer to address FDA requests related to the nebulizer device used in their Phase 2b trial of BX004 for cystic fibrosis patients. An independent Data Monitoring Committee completed a safety review and recommended continuing the study with revised dosing, with topline results expected in Q2 2026. The company is collaborating with the device manufacturer to provide additional information requested by the FDA, aiming to resume U.S. enrollment once the clinical hold is lifted. BiomX remains committed to advancing a potential treatment for Pseudomonas aeruginosa infections in cystic fibrosis patients.

Read more at GlobeNewswire: BiomX Provides Update on BX004 Phase 2b Trial in Cystic