---
schema_version: "secwatch.filing_event.v1"
accession: "0001999371-25-013498"
form_type: "8-K"
ticker: "TNXP"
cik: "0001430306"
company_name: "Tonix Pharmaceuticals Holding Corp."
filed_at: "2025-09-18T23:59:59+00:00"
generated_at: "2026-05-17T06:14:03.228137+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Tonix completes positive Pre-IND meeting with FDA for TNX-102 SL in MDD; IND filing Q4 2025

## Summary
- FDA found proposed long-term safety data collection plan generally reasonable, potentially streamlining development.
- Company plans to pursue sNDA to expand TNX-102 SL indication to include MDD.
- IND filing for TNX-102 SL in MDD planned for Q4 2025; Phase 2 trial expected shortly after.
- TNX-102 SL (sublingual cyclobenzaprine HCl) is already FDA-approved for fibromyalgia as Tonmya.
- Decision based on exploratory findings that improving sleep quality may positively impact depressive symptoms.

## SEC filing metadata
- accession: 0001999371-25-013498
- form_type: 8-K
- ticker: TNXP
- cik: 0001430306
- company_name: Tonix Pharmaceuticals Holding Corp.
- filed_at: 2025-09-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- 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/1430306/000199937125013498/0001999371-25-013498-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1430306/000199937125013498/tnxp_8k-091825.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001999371-25-013498
- JSON: https://secwatch.observer/filing/0001999371-25-013498.json
- Plain text: https://secwatch.observer/filing/0001999371-25-013498.txt

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