regulatory
confidence high
sentiment positive
materiality 0.95
Tonix receives FDA approval of Tonmya (cyclobenzaprine HCl) for fibromyalgia in adults
Tonix Pharmaceuticals Holding Corp.
- FDA approved Tonmya (cyclobenzaprine HCl sublingual tablets) for treatment of fibromyalgia in adults.
- Product launch and commercialization strategy underway; commercial team led by Thomas Englese.
- Webcast and conference call held August 18, 2025 to discuss approval and go-to-market plan.
- Management presented on product label, market opportunity, and key clinical data from TNX-102 SL trials.