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BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage company advancing novel natural and engineered phage therapies targeting specific pathogenic bacteria, today provided an update on progress relating to the previously disclosed U.S. Food and Drug Administration (FDA) clinical hold placed on the U.S. portion of the BX004 Phase 2b trial in cystic fibrosis (CF). The Company also announced that it has received new encouraging written feedback provided by the FDA outlining potential development strategies for BX004, including approaches to enrich study populations in Phase 3 development.
BX004 Phase 2b Trial Update
In responding to the initial clinical hold of the U.S. portion of the Phase 2b trial, BiomX, together with the third-party nebulizer manufacturer, promptly provided a comprehensive package of data and analyses to address the FDA's feedback and queries related to the third-party nebulizer device used to deliver BX004. Following its review of this package, the FDA issued an additional request for limited technical clarifications related to the nebulizer's performance. BiomX believes that it has fully addressed the FDA's queries, which are narrow in scope and pertain solely to the nebulizer device. The FDA has not raised any concern regarding the BX004 drug product itself.
Importantly, patient recruitment and dosing in Europe have continued ahead of plan throughout the U.S. clinical hold. The BX004 Phase 2b trial remains on track to report topline results in the first quarter of 2026. All third-party nebulizer components used in the European trial are CE marked and approved for use in the EU.
"Patient enrollment and dosing in Europe have progressed faster than expected, and the BX004 Phase 2b trial remains on track to report topline results in the first quarter of 2026," said Jonathan Solomon, Chief Executive Officer of BiomX. "In parallel, we have responded to the FDA's additional, limited queries regarding the data on the third-party nebulizer used to deliver BX004. We believe the information provided appropriately addresses the FDA's questions and look forward to continuing our dialog with the FDA to support a potential lifting of the clinical hold in the U.S. in the near term," stated Mr. Solomon.
New FDA Feedback on BX004 Development Pathways
BiomX has also received new written feedback from the FDA recognizing that, even in the era of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulators, there remains a significant unmet need for therapies addressing chronic Pseudomonas aeruginosa infection in individuals with CF. The FDA outlined several potential development pathways, including opportunities to refine inclusion criteria and enrich patient populations in a Phase 3 program, with the aim of enhancing the ability to demonstrate therapeutic benefits.
"We are encouraged by the FDA's perspective recognizing persistent unmet need in this patient population and by the constructive guidance on potential development pathways," added Mr. Solomon. "We believe this feedback can help us optimize study design and potentially broaden the clinical relevance of BX004, subject to future data from the Phase 2b trial, regulatory alignment, and resources."
BiomX plans to incorporate the FDA's recommendations, as appropriate, into ongoing development plans and anticipates further discussion with the FDA at an End-of-Phase 2 meeting following completion and review of the Phase 2b trial results.
Posted In: PHGE
