8-K
filed November 25, 2025, 6:59 PM ET
ticker PHGE
CIK 0001739174
regulatory
confidence high
sentiment negative
materiality 0.70
BiomX reports FDA clinical hold continues; DMC recommends adjusted dosing for Phase 2b CF study
BiomX Inc.
- 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.
Machine-readable event card
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- secwatch.filing_event.v1
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- 0001213900-25-114833
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- PHGE
- cik
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- company_name
- BiomX Inc.
- filed_at
- 2025-11-25T23:59:59+00:00
- discovered_at
- 2026-05-14T18:02:40.287912+00:00
- generated_at
- 2026-05-16T16:58:59.193272+00:00
- sec_items
- ["8.01"]
- event_type
- regulatory
- sentiment
- negative
- materiality_score
- 0.7
- calibrated_materiality_score
- 0.7
- confidence
- high
- secwatch_canonical_url
- https://secwatch.observer/filing/0001213900-25-114833
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- https://secwatch.observer/filing/0001213900-25-114833.json
- markdown_url
- https://secwatch.observer/filing/0001213900-25-114833.md
- text_url
- https://secwatch.observer/filing/0001213900-25-114833.txt
- edgar_index_url
- https://www.sec.gov/Archives/edgar/data/1739174/000121390025114833/0001213900-25-114833-index.htm
- edgar_primary_document_url
- https://www.sec.gov/Archives/edgar/data/1739174/000121390025114833/ea0267116-8k_biomx.htm
- generated_by_model
- deepseek-v4-flash:cloud@v2
- review_status
- machine_generated
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- false
- corrected
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- null
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