CNS - Tonix Pharma plans to submit IND for mid-stage TNX-102 SL study in Long COVID

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.

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Tonix Pharma plans to submit IND for mid-stage TNX-102 SL study in Long COVID