05:56 PM EST, 11/25/2025 (MT Newswires) -- BiomX ( PHGE ) said late Tuesday the US Food and Drug Administration is continuing its assessment of nebulizer device for administering the BX004 drug candidate to patients with cystic fibrosis as part of a phase 2b trial.

BiomX ( PHGE ) said it is working with the third-party manufacturer to address the FDA's follow-up requests to lift the regulator's clinical hold on the trial. The company expects US enrollment to resume after this process is completed, according to a statement.

An independent data monitoring committee carried out a safety review after adverse events were recorded in the trial. The committee recommended that the study continue with a revised dosing regimen, the company said.

The company is modifying trial protocol, and pending the availability of financial resources, topline results are now expected in Q2 2026, according to the company. Earlier, the company expected to report topline results from the study in Q1 of 2026.