---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-035741"
form_type: "8-K"
ticker: "TNXP"
cik: "0001430306"
company_name: "Tonix Pharmaceuticals Holding Corp."
filed_at: "2026-08-03T11:05:25+00:00"
generated_at: "2026-08-03T11:10:19.141638+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Tonix receives FDA alignment on Phase 2 study design for TNX-4800 Lyme disease prevention

## Summary
- FDA aligned on adaptive Phase 2 field study of TNX-4800 enrolling 3,300 adults over two seasons.
- Primary efficacy endpoint: Lyme disease prevention at 6 months; key secondary at 3 months.
- Manufacturing of investigational product on track for delivery to study sites in Q1 2027.
- TNX-4800 is a long-acting human monoclonal antibody targeting OspA, with potential advantages over vaccines.
- Majority of enrollment expected in 2028 season; may extend to 2029 if attack rate lower.

## SEC filing metadata
- accession: 0001493152-26-035741
- form_type: 8-K
- ticker: TNXP
- cik: 0001430306
- company_name: Tonix Pharmaceuticals Holding Corp.
- filed_at: 2026-08-03T11:05:25+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1430306/000149315226035741/0001493152-26-035741-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1430306/000149315226035741/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-035741
- JSON: https://secwatch.observer/filing/0001493152-26-035741.json
- Plain text: https://secwatch.observer/filing/0001493152-26-035741.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.