BiomX: FDA clinical hold update – narrow nebulizer queries, no drug concerns; EU enrollment ahead

BiomX Inc.

FDA provided additional narrow questions on third-party nebulizer; no concerns about BX004 drug product.
BiomX believes it has fully addressed the FDA's queries.
European portion of Phase 2b study continues enrollment ahead of plan; topline results on track for Q1 2026.
FDA recognized unmet medical need for chronic Pseudomonas aeruginosa infection in CF and outlined potential Phase 3 pathways.
BiomX plans to incorporate FDA feedback into development; expects End-of-Phase 2 meeting after trial completion.

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