BiomX Provides a Program Update and Announces New FDA Feedback Potentially Expanding BX004 Development Pathways
BiomX Inc. COmmon Stock (PHGE)
Company Research
Source: GlobeNewswire
BiomX believes that it has fully addressed the FDA’s queries related to the third-party nebulizer used to deliver BX004, which are narrow in scope; an additional FDA request for limited technical clarifications on the nebulizer has also been addressed In parallel, new written FDA feedback underscores the significant unmet need BiomX is addressing and outlines new potential development approaches European enrollment and dosing remain strong; Phase 2b study remains on track to report topline results in the first quarter of 2026 NESS ZIONA, Israel, Oct. 17, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies targeting specific pathogenic bacteria, today provided an update on progress relating to the previously disclosed U.S. Food and Drug Administration (FDA) clinical hold placed on the U.S. portion of the BX004 Phase 2b trial in cystic fibrosis (CF). The Company also
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News
- BiomX Provides Update on BX004 Phase 2b Trial in Cystic FibrosisGlobeNewswire
- BiomX Inc. Announces 1-for-19 Reverse Stock SplitGlobeNewswire
- BiomX Inc (PHGE) Q3 2025 Earnings Call Highlights: Strategic Advances Amid Financial Challenges [Yahoo! Finance]Yahoo! Finance
- BiomX outlines imminent FDA feedback and targets BX004 Phase IIb data in Q1 2026 while advancing BX011 for diabetic foot infections [Seeking Alpha]Seeking Alpha
- BiomX Inc. (PHGE) Q3 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
PHGE
Earnings
- 11/12/25 - Beat
PHGE
Sec Filings
- 11/25/25 - Form 8-K
- 11/17/25 - Form 8-K
- 11/12/25 - Form 10-Q
- PHGE's page on the SEC website