---
schema_version: "secwatch.filing_event.v1"
accession: "0001999371-25-018430"
form_type: "8-K"
ticker: "TNXP"
cik: "0001430306"
company_name: "Tonix Pharmaceuticals Holding Corp."
filed_at: "2025-11-24T23:59:59+00:00"
generated_at: "2026-05-16T17:17:08.665827+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Tonix Pharma receives FDA IND clearance for TNX-102 SL Phase 2 MDD study

## Summary
- FDA cleared IND for TNX-102 SL (cyclobenzaprine HCl) 5.6 mg sublingual tablets to treat major depressive disorder in adults.
- Potentially pivotal Phase 2 HORIZON study: 6-week, randomized, double-blind, placebo-controlled, 360 patients at ~30 U.S. sites.
- Primary endpoint: MADRS total score change from baseline at Week 6; enrollment to begin mid-2026.
- TNX-102 SL targets disrupted sleep associated with MDD; prior fibromyalgia and PTSD studies showed depression symptom improvements.

## SEC filing metadata
- accession: 0001999371-25-018430
- form_type: 8-K
- ticker: TNXP
- cik: 0001430306
- company_name: Tonix Pharmaceuticals Holding Corp.
- filed_at: 2025-11-24T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1430306/000199937125018430/0001999371-25-018430-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1430306/000199937125018430/tnxp-8k_112425.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001999371-25-018430
- JSON: https://secwatch.observer/filing/0001999371-25-018430.json
- Plain text: https://secwatch.observer/filing/0001999371-25-018430.txt

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