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# Clinical Hold on BiomX Cystic Fibrosis Therapy
- URL: https://www.fdaweb.com/clinical-hold-on-biomx-cystic-fibrosis-therapy/
- Published: 2025-08-19T12:00:00.000Z
- Updated: 2026-09-14T15:19:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159711

FDA has placed a clinical hold on a BiomX Phase 2b trial of BX004, an investigational phage therapy for cystic fibrosis (CF). The agency action does not relate to the BX004 drug itself, but instead concerns a third-party nebulizer device used to deliver the treatment, the company says. BiomX adds that FDA has already cleared BX004 for investigational use and raised no concerns about the drug candidate.

Following the hold, BiomX says it submitted additional data from the nebulizer’s manufacturer that the company expects will address the agency’s questions and allow the trial to resume in the U.S. In the meantime, screening and enrollment of U.S. patients is paused, while studies in Europe are continuing as planned, where the nebulizer is already CE-marked and approved for use, it says.

BiomX describes BX004 as a fixed multi-phage cocktail designed to treat chronic pulmonary infections caused by *Pseudomonas aeruginosa*, a leading cause of illness and death among people with cystic fibrosis. The therapy has shown encouraging results in earlier trials, improving lung function and reducing bacterial load in certain subgroups, it says.