---
schema_version: "secwatch.filing_event.v1"
accession: "0001999371-25-007790"
form_type: "8-K"
ticker: "TNXP"
cik: "0001430306"
company_name: "Tonix Pharmaceuticals Holding Corp."
filed_at: "2025-06-16T23:59:59+00:00"
generated_at: "2026-05-19T06:13:57.626545+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Tonix presents positive Phase 3 TNX-102 SL data at EULAR; PDUFA Aug 15, 2025

## Summary
- TNX-102 SL (sublingual cyclobenzaprine) showed statistically significant pain reduction in Phase 3 RESILIENT study at 14 weeks.
- FDA PDUFA goal date for TNX-102 SL is August 15, 2025; if approved, would be first new fibromyalgia drug in >15 years.
- Novel mechanism targets non-restorative sleep by acting on four post-synaptic receptors regulating sleep.
- Non-opioid analgesic designed for transmucosal delivery to bypass first-pass metabolism and reduce norcyclobenzaprine accumulation.
- Data presented at Annual European Congress of Rheumatology (EULAR) 2025 in Barcelona, June 11-14.

## SEC filing metadata
- accession: 0001999371-25-007790
- form_type: 8-K
- ticker: TNXP
- cik: 0001430306
- company_name: Tonix Pharmaceuticals Holding Corp.
- filed_at: 2025-06-16T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1430306/000199937125007790/0001999371-25-007790-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1430306/000199937125007790/tnxp-8k_06162025.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001999371-25-007790
- JSON: https://secwatch.observer/filing/0001999371-25-007790.json
- Plain text: https://secwatch.observer/filing/0001999371-25-007790.txt

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