BiomX Announces Positive FDA Feedback Supporting Next-Generation Phage Cocktail Program for Diabetic Foot Infections
BiomX Inc. COmmon Stock (PHGE)
Company Research
Source: GlobeNewswire
NESS ZIONA, Israel, Nov. 04, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: 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
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- 11/12/25 - Beat
PHGE
Sec Filings
- 11/25/25 - Form 8-K
- 11/17/25 - Form 8-K
- 11/12/25 - Form 10-Q
- PHGE's page on the SEC website