---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-078196"
form_type: "8-K"
ticker: "PHGE"
cik: "0001739174"
company_name: "BiomX Inc."
filed_at: "2025-08-19T23:59:59+00:00"
generated_at: "2026-05-17T11:30:51.655278+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA places clinical hold on BiomX's Phase 2b study of BX004 in CF due to nebulizer device

## Summary
- FDA hold pauses U.S. enrollment and screening for BX004 Phase 2b trial; no concerns about BX004 itself.
- Company submitted additional data to FDA; EU study continues as nebulizer is CE marked.
- Clinical hold triggered by third-party nebulizer device, not drug candidate BX004.
- BiomX noted risks in ability to resume U.S. enrollment and timing of hold resolution.

## SEC filing metadata
- accession: 0001213900-25-078196
- form_type: 8-K
- ticker: PHGE
- cik: 0001739174
- company_name: BiomX Inc.
- filed_at: 2025-08-19T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1739174/000121390025078196/0001213900-25-078196-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1739174/000121390025078196/ea0253854-8k_biomx.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-078196
- JSON: https://secwatch.observer/filing/0001213900-25-078196.json
- Plain text: https://secwatch.observer/filing/0001213900-25-078196.txt

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