---
schema_version: "secwatch.filing_event.v1"
accession: "0001999371-25-011478"
form_type: "8-K"
ticker: "TNXP"
cik: "0001430306"
company_name: "Tonix Pharmaceuticals Holding Corp."
filed_at: "2025-08-15T23:59:59+00:00"
generated_at: "2026-05-17T12:22:15.550485+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA approves Tonix's Tonmya for fibromyalgia; first new therapy in over 15 years

## Summary
- Tonmya (cyclobenzaprine HCl sublingual tablets) approved for adults with fibromyalgia; Q4 2025 commercial launch expected.
- Approval based on two Phase 3 trials (~1,000 patients) showing significant pain reduction vs placebo at 14 weeks.
- Over 10 million U.S. adults affected; Tonmya is first-in-class non-opioid bedtime analgesic.
- Company to host webcast August 18 at 8:30 AM ET to discuss approval.

## SEC filing metadata
- accession: 0001999371-25-011478
- form_type: 8-K
- ticker: TNXP
- cik: 0001430306
- company_name: Tonix Pharmaceuticals Holding Corp.
- filed_at: 2025-08-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1430306/000199937125011478/0001999371-25-011478-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1430306/000199937125011478/tnxp_8k-081525.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001999371-25-011478
- JSON: https://secwatch.observer/filing/0001999371-25-011478.json
- Plain text: https://secwatch.observer/filing/0001999371-25-011478.txt

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