secwatch.observer — SEC 8-K summary
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Issuer:     BiomX Inc. (PHGE)
CIK:        0001739174
Form:       8-K
Filed at:   2025-11-25T23:59:59+00:00
Accession:  0001213900-25-114833
Event type: regulatory
Sentiment:  negative
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

BiomX reports FDA clinical hold continues; DMC recommends adjusted dosing for Phase 2b CF study
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- FDA continues evaluation of third-party nebulizer used in BX004 Phase 2b cystic fibrosis study; clinical hold remains.
- Independent Data Monitoring Committee recommends adjusted dosing regimen; company updating trial protocol accordingly.
- Topline results now expected in Q2 2026, pending availability of financial resources and other factors.
- Company working with third-party manufacturer to address FDA follow-up requests; expects to lift hold.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1739174/000121390025114833/0001213900-25-114833-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1739174/000121390025114833/ea0267116-8k_biomx.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-114833

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer