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Investing.com - BiomX (NYSE:PHGE), currently trading at $0.55 and showing a notable 10% gain over the past week, announced Wednesday that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its ongoing BX004 Phase 2 trial in cystic fibrosis (CF).
The clinical hold stems solely from concerns related to the third-party nebulizer device used to deliver the phage therapy, not the BX004 therapy itself, which has previously received FDA clearance for clinical investigational use without objections. According to InvestingPro data, BiomX maintains a strong liquidity position with more cash than debt and a current ratio of 2.66, providing financial flexibility during this temporary setback.
BiomX has submitted requested safety data generated independently by the nebulizer device manufacturer to the FDA, which the company expects will provide sufficient information to lift the hold.
While patient screening and enrollment in the U.S. portion of the Phase 2b trial is temporarily paused, enrollment and dosing of patients in the European Union continues according to protocol guidance, as all components of the third-party nebulizer device are CE marked in Europe.
H.C. Wainwright has reiterated a Buy rating and $15.00 price target on BiomX stock, with the research firm noting it does not view the clinical hold as a high impact event for the company and expects the pause to be resolved quickly with minimal effect on anticipated clinical timelines.
In other recent news, BiomX Inc. has announced that the U.S. Food and Drug Administration has placed a clinical hold on its Phase 2b trial of BX004, a phage therapy for cystic fibrosis patients. The hold is due to concerns with the third-party nebulizer device used for delivering the therapy, not the BX004 drug itself. BiomX has responded by submitting additional data from the nebulizer’s manufacturer to address the FDA’s request. In another development, BiomX plans to hold its 2025 Annual Meeting of Stockholders on October 16, 2025, with August 22, 2025, set as the record date for shareholder voting eligibility. H.C. Wainwright has reiterated its Buy rating for BiomX, maintaining a price target of $15.00, citing the company’s progress in its Phase 2b trial for BX004 and its lead phage cocktail assets. The trial, which has commenced patient dosing, evaluates BX004 for treating chronic respiratory infections in cystic fibrosis patients. This follows a positive Phase 1b/2a study where a portion of patients cleared infections completely. BiomX anticipates topline results from this trial in the first quarter of 2026.
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