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Tonix Pharmaceuticals Holding / Equity Bottom-Up

<p>Tonix has announced that it has been granted Breakthrough Therapy Designation (BTD) by the FDA as its Phase II AtEase data for TNX-102 SL in military-related PTSD indicate the drug may successfully treat a serious condition, a key requirement for BTD. Key benefits of BTD are intensive guidance from the FDA on the drug development program, an organizational commitment involving senior managers at the FDA, and the submission of portions of the NDA on a rolling basis.</p>

Tonix has announced that it has been granted Breakthrough Therapy Designation (BTD) by the FDA as its Phase II AtEase data for TNX-102 SL in military-related PTSD indicate the drug may successfully treat a serious condition, a key requirement for BTD. Key benefits of BTD are intensive guidance from the FDA on the drug development program, an organizational commitment involving senior managers at the FDA, and the submission of portions of the NDA on a rolling basis.

<p>Tonix recently held a post-traumatic stress disorder (PTSD) awareness day to highlight the current standards of care, the unmet medical need of the disease as well as the development plan for TNX-102 SL to treat it. The first Phase III trial in military-related PTSD will enroll up to 550 patients and will have one to two interim analyses, which would allow for early stoppage due to efficacy or a sample size adjustment. The trial is expected to start in Q117, with the first interim analyses expected in H217. A second trial in predominantly civilian PTSD is expected to follow.</p>

Tonix recently held a post-traumatic stress disorder (PTSD) awareness day to highlight the current standards of care, the unmet medical need of the disease as well as the development plan for TNX-102 SL to treat it. The first Phase III trial in military-related PTSD will enroll up to 550 patients and will have one to two interim analyses, which would allow for early stoppage due to efficacy or a sample size adjustment. The trial is expected to start in Q117, with the first interim analyses expected in H217. A second trial in predominantly civilian PTSD is expected to follow.

United States

Tonix Pharmaceuticals Holding Corp. is a pharmaceutical company that develops therapies for disorders of the central nervous system ("CNS").  The Company develops therapies for disorders that include fibromyalgia syndrome ("FM") and post-traumatic stress disorder ("PTSD"),

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Tonix Pharmaceuticals Holding (TNXP US)

Breakthrough Therapy Designation in PTSD

Tonix has announced that it has been granted Breakthrough Therapy Designation (BTD) by the FDA as its Phase II AtEase data for TNX-102 SL in...

Edison Investment Research

PTSD awareness day and earnings update

Tonix recently held a post-traumatic stress disorder (PTSD) awareness day to highlight the current standards of care, the unmet medical need of the...

Edison Investment Research

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