BiomX Inc. (NYSE:PHGE) on Tuesday announced that the U.S. Food and Drug Administration (FDA) is continuing its evaluation of the nebulizer device used for drug administration in the company's Phase 2b trial of BX004 in cystic fibrosis patients.
- PHGE shares are retreating from recent levels. See the complete data here
The company is working with the third-party manufacturer to address recent FDA follow-up information requests in order to lift the FDA's clinical hold with respect to the trial.
The FDA has placed a clinical hold on the Phase 2b study as it reviews data submitted by BiomX on the third-party nebulizer used to deliver BX004.
FDA Scrutiny: What's Holding BiomX Back?
No concerns were raised in the clinical hold notification regarding the BX004 drug candidate. Enrollment and dosing of patients outside the U.S. is continuing in accordance with protocol.
BiomX recently received additional follow-up questions from the FDA related to the third-party nebulizer device used for BX004 administration. The company is working closely with the device manufacturer to assemble the additional information requested by the FDA. BiomX considers the outstanding items readily addressable to resolve the outstanding questions raised by the FDA while maintaining a productive and ongoing dialogue with the Agency.
The company expects enrollment in the U.S. to resume once this process is complete.
In parallel, an independent Data Monitoring Committee (DMC) has completed a safety review of the BX004 Phase 2b clinical trial.
The review included participants who experienced adverse events, and following its evaluation, the DMC recommended that the study continue with an adjusted dosing regimen.
What Next?
In accordance with the recommendations, BiomX is updating the trial protocol, and pending availability of financial resources and other factors, topline results are now expected in the second quarter of 2026.
"We are encouraged by the DMC's conclusion that the BX004 study may continue once the adjusted dosing regimen has been implemented," said Jonathan Solomon, Chief Executive Officer of BiomX.
Cash balance and restricted cash as of September 30, 2025, were $8.1 million. BiomX estimates that its cash, cash equivalents, and restricted cash are sufficient to fund its operations into the first quarter of 2026.
Recently, BiomX announced a 1-for-19 reverse split.
PHGE Price Action: BiomX shares were down 7.18% at $5.36 at the time of publication on Wednesday. The stock is near its 52-week low of $4.65, according to Benzinga Pro data.
Read Next:
Photo via Shutterstock
