BiomX has addressed the FDA’s queries regarding the nebulizer used for BX004 delivery, with additional clarifications provided. New FDA feedback emphasizes the unmet need in treating chronic Pseudomonas aeruginosa infections in CF patients. European enrollment for the Phase 2b study is strong, with topline results expected in Q1 2026. BiomX is incorporating FDA recommendations for potential Phase 3 development pathways. The company remains optimistic about the progress of the BX004 trial and the potential for lifting the U.S. clinical hold in the near future.

Patient recruitment and dosing in Europe are ahead of schedule for the BX004 trial, with a focus on addressing the significant unmet need for CF treatments. BiomX is working on potential development strategies in response to encouraging FDA feedback. The Phase 2b trial is on track to report topline results in Q1 2026, with ongoing discussion with the FDA regarding study design optimization. BiomX remains committed to advancing novel phage therapies for chronic diseases.

Read more at GlobeNewswire: BiomX Provides a Program Update and Announces New FDA