TNX-1300 (double-mutant cocaine esterase) — FDA meeting
2026
The Company plans to meet with the FDA in 2026 to inform the clinical design of the next Phase 2 study (a Phase 2 study has been completed).Source filing
TNXP biotech catalysts & pipeline
TONIX PHARMACEUTICALS HOLDING CORP · Data as of 2026-09-08
Upcoming catalysts
TNX-4800 (anti Borrelia OspA human monoclonal antibody) — FDA meeting
Q3 2026
In April 2026, the Company announced it has scheduled a Type C meeting with the FDA early in the third quarter of 2026 to discuss the planned adaptive Phase 2 field study design.Source filing
TNX-102 SL (sublingual cyclobenzaprine HCl) — Topline data
mid-2027
Topline data is expected to be reported mid-2027.Source filing