other material
confidence high
sentiment neutral
materiality 0.60
Tonix enrolls first patient in Phase 2 MDD study of TNX-102 SL (TONMYA)
Tonix Pharmaceuticals Holding Corp.
- First patient enrolled in HORIZON, a potentially pivotal Phase 2 study of TNX-102 SL 5.6 mg as first-line monotherapy for major depressive disorder.
- Primary endpoint: change from baseline in MADRS total score at Week 6; about 360 patients at ~30 US sites.
- TNX-102 SL (TONMYA) was FDA approved for fibromyalgia in August 2025; MDD indication is investigational.
- CEO notes TNX-102 SL targets poor sleep quality; prior signals in PTSD and fibromyalgia studies.