Tonix Announces Successful End-of-Phase 2 Meeting with FDA For PTSD Drug

Tonix Pharmaceuticals Holding Corp. TNXP shares are trading up nearly 5 percent (after hitting a high of $2.75) after the company disclosed the successful End-of-Phase 2/Pre-Phase 3 meeting with the FDA. The company said the minutes confirmed the regulator's acceptance of its planned final stage trial and the proposed NDA data package to support the registration of TNX-102 SL for post-traumatic stress disorder.

Tonix said the final minutes from the FDA suggested the positive results from two well-controlled final phase efficacy and safety studies. Aside from this, the long-term safety exposure studies would offer enough proof of efficacy and safety to support TNX-102 SL registration.

The company expects the first final phase trial to be in military-related PTSD patients and the second final stage trial would be predominantly civilian PTSD patients.

President and CEO Seth Lederman commented, "Considering the FDA's concurrence that the primary endpoint used in the AtEase study will be the same primary endpoint for both upcoming Phase 3 trials, we remain confident in achieving this important milestone. The promising data from the AtEase study supports the potential for TNX-102 SL to be an effective treatment for this large and growing patient population. Importantly, we believe the urgent medical need to treat military-related PTSD also creates the possibility for a Breakthrough Therapy Designation."

Following the news, the stock traded up by $0.12, or 4.92 percent, to $2.56.