BiomX Provides Update on BX004 Phase 2b Trial in Cystic Fibrosis - BiomX (AMEX:PHGE)

Core Viewpoint - BiomX Inc. is addressing FDA follow-up information requests to lift the clinical hold on its Phase 2b trial for BX004, a treatment targeting Pseudomonas aeruginosa in cystic fibrosis patients, with topline results now expected in Q2 2026 [1][4][5] Company Updates - The FDA is continuing its evaluation of the nebulizer device used for BX004 administration, and BiomX is collaborating with the third-party manufacturer to provide the necessary information [1][2] - An independent Data Monitoring Committee (DMC) has completed a safety review of the BX004 Phase 2b trial and recommended that the study continue with an adjusted dosing regimen [3][4] - The trial protocol will be updated accordingly, and pending financial resources, the company expects to enroll approximately 60 patients in the Phase 2b trial [5] Product Information - BX004 is a fixed multi-phage cocktail designed to target Pseudomonas aeruginosa, which significantly impacts morbidity and mortality in cystic fibrosis patients [5] - Positive results from earlier phases of the trial indicated safety, tolerability, and improvement in pulmonary function associated with reduced bacterial load [5] Future Expectations - The company remains optimistic about the path forward for BX004 and looks forward to reporting topline results in the second quarter of 2026 [4][5]