BiomX Awaits FDA Clearance To Restart Cystic Fibrosis Trial After Nebulizer Device Review

Core Viewpoint - BiomX Inc. is currently under FDA evaluation for its nebulizer device used in the Phase 2b trial of BX004 for cystic fibrosis, with a clinical hold in place due to data review concerns regarding the device [1][2][3]. Group 1: FDA Evaluation and Clinical Hold - The FDA has placed a clinical hold on the Phase 2b study while reviewing data submitted by BiomX regarding the third-party nebulizer used for BX004 delivery [2][4]. - No concerns were raised about the BX004 drug candidate itself in the clinical hold notification, and patient enrollment and dosing outside the U.S. continue as per protocol [3][4]. Group 2: Company Actions and Future Expectations - BiomX is collaborating with the nebulizer manufacturer to address the FDA's follow-up information requests, which are considered readily addressable [4]. - The company anticipates that U.S. enrollment will resume once the FDA's concerns are resolved, and topline results are now expected in the second quarter of 2026 following protocol updates [5][6]. Group 3: Financial Position and Stock Performance - As of September 30, 2025, BiomX reported a cash balance of $8.1 million, which is projected to fund operations into the first quarter of 2026 [7]. - BiomX shares experienced a decline of 7.18%, trading at $5.36, close to its 52-week low of $4.65 [7].