NESS ZIONA, Israel — August 19, 2025 — Leads & Copy — The U.S. Food and Drug Administration (FDA) has placed a clinical hold on BiomX Inc.’s Phase 2b trial of BX004 for cystic fibrosis (CF) patients, the company announced today. The FDA’s concerns are focused on the third-party nebulizer used to deliver the drug. Enrollment and dosing of patients outside the U.S. will continue as planned.
According to the company, the FDA’s notification relates solely to the nebulizer, and BiomX said it promptly submitted the additional requested data which was generated independently by the well-established manufacturer of the nebulizer device.
BiomX is actively engaged with the FDA to address their queries, stated CEO Jonathan Solomon, who added that the company remains optimistic that the provided data will support the nebulizer’s use and allow the trial to resume in the U.S.
BX004 is a fixed multi-phage cocktail developed by BiomX to treat CF patients with chronic pulmonary infections caused by Pseudomonas aeruginosa. It has received U.S. FDA Fast Track and Orphan Drug Designations.
Ben Cohen
Head Corporate Communications
benc@biomx.com
Source: BiomX Inc.
