BiomX (NYSE American: PHGE) has announced that the FDA is continuing its evaluation of the nebulizer device used for drug administration in the company’s Phase 2b trial of BX004 in patients with cystic fibrosis (CF).
According to BiomX, the company is working with the third-party manufacturer to address recent FDA follow up information requests in order to lift the FDA’s clinical hold with respect to the trial. In parallel, an independent DMC has completed a safety review of the BX004 Phase 2b clinical trial. Separately, an independent data monitoring committee (DMC) has conducted a safety review of the BX004 Phase 2b clinical trial, and recommended that the study continue with an adjusted dosing regimen.
In a statement, Jonathan Solomon, CEO of BiomX, commented, “We are encouraged by the DMC’s conclusion that the BX004 study may continue once the adjusted dosing regimen has been implemented. We remain committed to advancing a potential treatment for the unmet need of Pseudomonas aeruginosa (P. aeruginosa) infections in patients with CF. We are working closely with our device manufacturer to provide the FDA with the remaining clarifications and remain confident in the path forward for BX004. We look forward to reporting topline results in the second quarter of 2026.”
