BiomX Inc. (PHGE) announced the discontinuation of its Phase 2b clinical trial evaluating BX004, a nebulized phage therapy for patients with cystic fibrosis associated with chronic Pseudomonas aeruginosa infections.
Cystic fibrosis (CF) is a rare, progressive genetic disease that leads to persistent lung infections and declining respiratory function.
The decision follows feedback from the independent Data Monitoring Committee (DMC) and an internal analysis that identified unexpectedly high rates of adverse events. On November 25, 2025, BiomX disclosed that the FDA had placed a hold on U.S. enrollment due to outstanding questions regarding the nebulizer device used for BX004 administration. The company was working with its third-party manufacturer to address these requests, but the DMC's safety review recommended protocol adjustments, including revised dosing.
BiomX stated that the projected timelines and resources required to evaluate alternative dosing or treatment strategies were beyond the company's current capabilities, leading to the difficult decision to halt the program.
The Phase 2b trial was designed as a randomized, double-blind study to assess the safety and efficacy of BX004 in CF patients with chronic Pseudomonas aeruginosa infections. While the therapy was intended to leverage BiomX's expertise in engineered bacteriophage cocktails, the company emphasized that patient safety remained the top priority.
BiomX will now shift its focus to advancing BX011, a fixed phage cocktail targeting Staphylococcus aureus infection in patients with diabetic foot infections (DFI).
The company also announced cost-cutting measures, including a significant workforce reduction, while reviewing strategic alternatives to maximize shareholder value.
Chief Executive Officer Jonathan Solomon commented, "Our first priority is the improved treatment, health and safety of patients in the cystic fibrosis community. Ultimately, the projected timelines and resources required to proceed safely were beyond our currently available resources."
PHGE closed yesterday's trading at $3.26, down 36.94%, and fell further in the overnight session to $3.25, down 0.31%. Over the past 12 months, the stock has traded between $2.92 and $22.05.
For comments and feedback contact: editorial@rttnews.com
Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.