Tonix Pharmaceuticals Holding Corp. TNXP
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) is a pain/anesthesia drug developer. Its lead program, TONMYA (cyclobenzaprine sublingual, TNX-102 SL), is in Phase 2 for fibromyalgia. Its next catalyst on record is TNX-102 SL: OASIS ASD topline (H1 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: TNX-102 SL — OASIS ASD topline (H1 2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| TONMYA | fibromyalgia | small molecule | Approved |
| Zembrace SymTouch | acute migraine | small molecule | Approved |
| Tosymra | acute migraine | small molecule | Approved |
| TNX-102 SL (HORIZON) | major depressive disorder | small molecule | Phase 2 |
| TNX-102 SL (OASIS) | autism spectrum disorder | small molecule | Phase 2 |
| TNX-1300 | cocaine intoxication | protein/peptide | Phase 2 |
Recent results and decisions
- Jun 29, 2026started First patient enrolled in the potentially pivotal Phase 2 HORIZON study of TNX-102 SL 5.6 mg in MDD (about 360 patients, primary endpoint MADRS change at Week 6).
Tonix Pharmaceuticals Announces First Patient Enrolled in Phase 2 HORIZON Study of TNX-102 SL for the Treatment of Major Depressive Disorder (MDD)
Filing - May 27, 2026positive Published Phase 1 SAD study (26 healthy adults): well tolerated with no SAEs; blocked primary anti-KLH T-cell dependent antibody response at all doses and secondary response at 10 and 30 mg/kg (about 70% peak reduction at 3 mg/kg).
TNX-1500 was generally well tolerated, with no serious adverse events, and no discontinuations due to adverse events.
Filing - May 15, 2026positive Poster re-presents Phase 1 (N=44 healthy volunteers): no significant safety signals, dose-proportional PK, mean half-life 62-69 days, transient ADAs in 3/34 treated subjects.
No significant clinical or laboratory signals were identified at any dose level.
Filing
4 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 pain/anesthesia companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.