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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 announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on the proposed clinical developmental pathway for BX011, a next-generation fixed multi-phage cocktail targeting Staphylococcus aureus (S. aureus) in diabetic foot infections (DFI).
FDA feedback supports BiomX's plan to advance its phage-based therapy into DFI as the next clinical indication, following the Company's previous Phase 2 study of BX211, a phage product for the treatment of diabetic foot osteomyelitis (DFO) caused by S. aureus. The decision to focus on DFI reflects three key factors: a broader patient population with a significant unmet medical need, a large commercial opportunity, and a clear regulatory path supported by established FDA guidance. The two indications share the same S. aureus pathogen, making DFI the appropriate initial indication for regulatory approval prior to potential development in DFO.
The new formulation, BX011, includes multiple proprietary phages, among them phage previously evaluated in the BX211 study. BiomX's development of phage therapies for S. aureus has been supported by approximately $40 million in non-dilutive funding from the U.S. DHA and Department of Navy funding under an Other Transaction Authority (OTA) award through the Medical Technology Enterprise Consortium (MTEC) and managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD). BX011's advancement will continue in alignment with ongoing discussions with the U.S. Defense Health Agency (DHA) and subject to the availability of necessary financial resources, with plans to initiate a Phase 2a clinical trial in DFI.
The FDA provided detailed guidance supporting a path toward a potential Biologics License Application (BLA). No additional non-clinical studies are expected, and the FDA's comments on Chemistry, Manufacturing, and Controls (CMC) are consistent with BiomX's existing manufacturing and quality strategy. The feedback confirms that the BX011 development plan is in accordance with current FDA guidance for DFI product development.
Posted In: PHGE
