- Tonix Pharmaceuticals (NASDAQ:TNXP) gains 13.7% premarket after receiving official minutes from a Type B pre-IND meeting with the FDA to develop TNX-102 SL (cyclobenzaprine HCl sublingual tablets) as a potential treatment for Long COVID Syndrome (Long COVID).
- Based on the minutes, the Company is planning to submit the IND in Q4 2021 to support a Phase 2 study for the management of a subset of Long COVID patients whose symptoms overlap with fibromyalgia.
- TNX-102 SL, a patented sublingual tablet formulation of cyclobenzaprine hydrochloride is in mid-Phase 3 development for the management of fibromyalgia.