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Pivotal Phase 2b/3 trial of BX004

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Trial Profile

Pivotal Phase 2b/3 trial of BX004

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 26 Mar 2025

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At a glance

  • Drugs BX 004 (Primary)
  • Indications Pseudomonal infections
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 25 Mar 2025 According to a BiomX media release, Discussions with the U.S. Food and Drug Administration (FDA) and other regulatory authorities are expected during the second half of 2025, during which the Company intends to present its analyses of real-world evidence and will seek to obtain endorsement that supports potential future regulatory filings.
  • 26 Feb 2025 According to a BiomX media release, Pending progress of the trial and company expects to report topline results from the Phase 2b study in Q1 2026.
  • 26 Feb 2025 According to a BiomX media release, company announced series of financing for aggregate gross proceeds of $12 million and it intends to use the net proceeds from the Offerings to support the completion of the Phase 2b clinical study of BX004.

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