Tonix Pharmaceuticals down 60% premarket on failed Tonmya study

Tonix Pharmaceuticals (NASDAQ:TNXP) has decided to stop enrollment in a Phase 3 clinical trial, RECOVERY, evaluatinng Tonmya (cyclobenzaprine HCl sublingual tablets) 5.6 mg (TNX-102 SL) for the treatment of posttraumatic stress disorder (PTSD).

The company took action after a prespecified interim analysis by the Independent Data Monitoring Committee showed that the study is unlikely to achieve the primary endpoint.

It plans to continue studying the current participants (50% enrolled) until completion, then proceed to a full analysis of the unblinded data to determine next steps. Topline results should be available next quarter.

Tonix will reallocate resources from the PTSD program to the Phase 3 fibromyalgia study of TNX-102 SL 5.6 mg. Interim data are expected in Q3.

Shares down 60% premarket on light volume.

https://seekingalpha.com/news/3539048-tonix-pharmaceuticals-down-60-premarket-on-failed-tonmya-study