other material
confidence high
sentiment positive
materiality 0.55
Tonix presents TNX-4800 Phase 1 data; plans adaptive Phase 2 field study for Lyme disease prevention in H1 2027
Tonix Pharmaceuticals Holding Corp.
- Phase 1 data of TNX-4800 (anti-OspA mAb) for Lyme disease presented at Ticks and Tickborne Diseases Symposium.
- Planned adaptive Phase 2 field study: two-dose SC regimen, primary endpoint 6-month protection; start H1 2027 pending FDA agreement.
- FDA Type C meeting scheduled early Q3 2026 to discuss Phase 2 study design.
- Each fixed subcutaneous dose expected to provide exposure comparable to 5 mg/kg dose in Phase 1.