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

BiomX Inc.

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.

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