Tonix on go with new late-stage study of Tonmya in PTSD

Tonix Pharmaceuticals (NASDAQ:TNXP) is up 26% premarket on modest volume on the heels of its announcement that the FDA is on board with the design of a new Phase 3 clinical trial, RECOVERY, evaluating Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of posttraumatic stress disorder (PTSD). The study will commence next quarter.

New design features include restricting participants to those with PTSD who experienced an index trauma within nine years of screening and including patients who have experienced civilian traumas (in addition to military traumas). The primary endpoint will be the mean change from baseline in the severity of PTSD symptoms as measured by a scale called CAPS-5.

Shares tanked in July when the company stopped the first Phase 3, HONOR, due to lack of efficacy.

https://seekingalpha.com/news/3413107-tonix-go-new-late-stage-study-tonmya-ptsd-shares-26-percent-premarket