---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-030408"
form_type: "8-K"
ticker: "TNXP"
cik: "0001430306"
company_name: "Tonix Pharmaceuticals Holding Corp."
filed_at: "2026-06-29T11:05:56+00:00"
generated_at: "2026-06-29T11:10:31.860070+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Tonix enrolls first patient in Phase 2 MDD study of TNX-102 SL (TONMYA)

## Summary
- First patient enrolled in HORIZON, a potentially pivotal Phase 2 study of TNX-102 SL 5.6 mg as first-line monotherapy for major depressive disorder.
- Primary endpoint: change from baseline in MADRS total score at Week 6; about 360 patients at ~30 US sites.
- TNX-102 SL (TONMYA) was FDA approved for fibromyalgia in August 2025; MDD indication is investigational.
- CEO notes TNX-102 SL targets poor sleep quality; prior signals in PTSD and fibromyalgia studies.

## SEC filing metadata
- accession: 0001493152-26-030408
- form_type: 8-K
- ticker: TNXP
- cik: 0001430306
- company_name: Tonix Pharmaceuticals Holding Corp.
- filed_at: 2026-06-29T11:05:56+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1430306/000149315226030408/0001493152-26-030408-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1430306/000149315226030408/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-030408
- JSON: https://secwatch.observer/filing/0001493152-26-030408.json
- Plain text: https://secwatch.observer/filing/0001493152-26-030408.txt

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