Biomx Inc Stock Price, News & Analysis

BiomX (NYSE American: PHGE) received positive FDA feedback on the clinical development pathway for BX011, a fixed multi-phage cocktail targeting Staphylococcus aureus in diabetic foot infections (DFI), and plans a Phase 2a trial in DFI subject to funding.

The FDA support includes a path toward a potential BLA, no additional non‑clinical studies expected, and CMC comments consistent with BiomX’s manufacturing strategy. BX011 uses multiple proprietary phages, including one evaluated in the prior BX211 Phase 2 DFO study, which reported statistically significant topline ulcer-size reductions. BiomX has received about $40 million in non-dilutive U.S. defense funding for its S. aureus phage program.

BiomX (NYSE American: PHGE) provided a program update on BX004 and new FDA feedback on Oct 17, 2025. The company says it has responded to the FDA's limited technical clarifications about the third‑party nebulizer used to deliver BX004 and believes those queries are fully addressed. The FDA did not raise concerns about the BX004 drug product.

Key points: European enrollment and dosing continued ahead of plan; all European nebulizer components are CE marked; the Phase 2b study remains on track to report topline results in Q1 2026. The FDA also provided written feedback recognizing unmet need in chronic Pseudomonas aeruginosa infection and outlined potential Phase 3 enrichment and development pathways.

BiomX (NYSE American: PHGE) announced that CEO Jonathan Solomon will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 8th, 2025, from 4:30 - 5:00 PM ET at the Lotte New York Palace Hotel in New York City.

The presentation, titled "Phage Therapy: A Novel Approach to Chronic Diabetic Foot Infections," will highlight the positive topline results from the company's Phase 2 trial of BX211 for treating Diabetic Foot Osteomyelitis (DFO). Investors can request one-on-one meetings through H.C. Wainwright representatives.

BiomX (NYSE American: PHGE) announced that the FDA has placed a clinical hold on the Phase 2b trial of BX004, their cystic fibrosis treatment. The hold specifically concerns the third-party nebulizer device used for drug delivery, with no issues raised about the BX004 drug candidate itself.

The company has already submitted additional requested data from the nebulizer manufacturer to the FDA. While U.S. patient screening and enrollment are temporarily paused, the European trial continues unaffected as the nebulizer components are CE marked and meet EU regulatory requirements.

BiomX (NYSE American: PHGE) reported significant clinical progress and Q2 2025 financial results. The company achieved positive Phase 2 results for BX211 in diabetic foot osteomyelitis, demonstrating >40% wound size reduction versus placebo. Their BX004 program showed promising results with a ~500-fold bacterial reduction in cystic fibrosis patients, as published in Nature Communications.

The company has initiated patient dosing in the Phase 2b trial of BX004, with topline results expected in Q1 2026. Financial highlights include a cash balance of $15.2 million as of June 30, 2025, with funding runway into Q1 2026. Q2 2025 showed reduced operating expenses, with R&D expenses at $5.0 million (down from $6.9M) and net loss of $6.0 million.

BiomX (NYSE American: PHGE), a clinical-stage company focused on developing phage therapies targeting specific pathogenic bacteria, has scheduled its second quarter 2025 financial results and program updates announcement for August 13, 2025, before U.S. markets open.

The company will host a conference call and audio webcast at 8:00 AM ET on the same day. Participants are advised to register at least 5 minutes before the call begins. Those not planning to ask questions are encouraged to join via the webcast, which will be available both live and archived in the Investors section of BiomX's website.

BiomX (NYSE American: PHGE) has initiated patient dosing in its Phase 2b trial of BX004, a phage therapy targeting antibiotic-resistant Pseudomonas aeruginosa infections in cystic fibrosis patients. The randomized, double-blind, placebo-controlled study will evaluate approximately 60 patients over an 8-week treatment period.

The trial follows promising Phase 1b/2a results where 14.3% of patients achieved complete bacterial clearance after just 10 days of treatment. The company expects topline results in Q1 2026 and anticipates FDA feedback in H2 2025 regarding the use of real-world evidence linking bacterial reduction to clinical outcomes. BX004 has already received Fast Track and Orphan Drug designations.

BiomX (NYSE American: PHGE) has published Phase 1b/2a Part 1 trial results of its phage cocktail BX004 in Nature Communications, demonstrating significant efficacy against antibiotic-resistant P. aeruginosa infections in cystic fibrosis patients.

The study revealed a remarkable 500-fold (2.7 log₁₀) bacterial reduction compared to placebo, with no emerging resistance. Key findings include a strong safety profile, successful bacterial reduction achieved at day 15, and therapeutic phages reaching and persisting at infection sites. The treatment demonstrated favorable microbiome composition shifts and maintained efficacy where traditional antibiotics often fail.

BiomX is currently advancing its Phase 2b trial of BX004, with topline results expected in Q1 2026.

BiomX (NYSE American: PHGE) announced that CEO Jonathan Solomon will present at the Biomed Israel 2025 conference in Tel Aviv, Israel, from May 20-22, 2025. The presentation will focus on the company's positive topline Phase 2 results for BX211, a phage therapy targeting Staphylococcus aureus in Diabetic Foot Osteomyelitis (DFO). Solomon will deliver an oral presentation titled "Precision Phage Therapy for Chronic Diabetic Foot Infections" during the Immunology & Inflammation session on May 21, 2025, at the InterContinental David Tel Aviv.