---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-099752"
form_type: "8-K"
ticker: "PHGE"
cik: "0001739174"
company_name: "BiomX Inc."
filed_at: "2025-10-17T23:59:59+00:00"
generated_at: "2026-05-17T03:24:48.153606+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# BiomX: FDA clinical hold update – narrow nebulizer queries, no drug concerns; EU enrollment ahead

## Summary
- FDA provided additional narrow questions on third-party nebulizer; no concerns about BX004 drug product.
- BiomX believes it has fully addressed the FDA's queries.
- European portion of Phase 2b study continues enrollment ahead of plan; topline results on track for Q1 2026.
- FDA recognized unmet medical need for chronic Pseudomonas aeruginosa infection in CF and outlined potential Phase 3 pathways.
- BiomX plans to incorporate FDA feedback into development; expects End-of-Phase 2 meeting after trial completion.

## SEC filing metadata
- accession: 0001213900-25-099752
- form_type: 8-K
- ticker: PHGE
- cik: 0001739174
- company_name: BiomX Inc.
- filed_at: 2025-10-17T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1739174/000121390025099752/0001213900-25-099752-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1739174/000121390025099752/ea0261617-8k_biomx.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-099752
- JSON: https://secwatch.observer/filing/0001213900-25-099752.json
- Plain text: https://secwatch.observer/filing/0001213900-25-099752.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.