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Tonix Pharmaceuticals Holding Corp. had an overwhelming start today after it released positive patient enrollment news, fuelling investor excitement.

The company will be presenting at the MicroCap Conference of its treatment of posttraumatic stress disorder (PTSD). The US Food and Drug Administration (FDA) previously granted Breakthrough Therapy Designation (BTD) for Tonix’s PTSD clinical program earlier this year.

The announcement comes as its Phase II AtEase data for TNX-102 SL in military-related PTSD shows the drug may successfully treat a serious condition, a crucial 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.

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The company, which is developing ground-breaking pharmaceutical products to address public health issues, will be presenting at The MicroCap Conference on April 4, 2017, held in New York, NY.

First Patient in PTSD Program

Earlier this week, Tonix also dosed the first patient for the HONOR study, a 12-week placebo-controlled Phase 3 clinical study evaluating TNX-102 SL 5.6 mg, in military-related PTSD.

Tonix’s president and CEO, Seth Lederman M.D., said that, “Enrolling the first patient in the HONOR study is an important event not only to Tonix, but potentially to millions who suffer worldwide from both civilian and military-related PTSD... The HONOR study is designed to confirm the clinical benefit of TNX-102 SL to improve PTSD symptoms across several measures as demonstrated in our Phase 2 AtEase study in military-related PTSD.”

The interim analysis of the HONOR study is anticipated in the first half of 2018. Topline results are expected in the second half of next year.

Dr. Lederman is slated to give a corporate update and an overview of the company’s PTSD clinical program. In his podium presentation, the CEO will also provide details of the pharmaceutical firm’s recently expanded therapeutic pipeline in PTSD and the new development program in a possible smallpox-preventing vaccine containing a live form of horsepox virus (HPXV), TNX-801.

Note that the TNX-102 SL, in forms of cyclobenzaprine HCl sublingual tablets, remains an investigational new drug and has not been approved for any indication.

Granted for all of PTSD

With the FDA granting BTD for the whole indication, the said administration may be implying it does not see military-related and civilian PTSD as fundamentally contrasting, hence, only one application will suffice.

PTSD may be developed from witnessing or experiencing a traumatic event where severe threat or actual occurrence of serious physical harm or death is present. This disorder affects roughly 8.6 million Americans and is a chronic and severely debilitating condition in which patients re-experience the traumas that resulted in the condition in the forms of invasive memories, flashbacks, and nightmares.

It is estimated that over 19% of the 1.9 million US veterans who were deployed to the recent conflicts in Iraq and Afghanistan suffer from PTSD.

As of writing, Tonix projects to begin a second Phase III in predominantly civilian PTSD victims after the start of the HONOR study. While the FDA may not view military and civilian PTSD as unalike, the trial will likely be required to gain adequate exposure in female PTSD sufferers.

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TNXP Stock analysis

After news on Tonix to discuss its PTSD clinical program at the MicroCap Conference, and the implication that its drug may be able to treat the disorder, TNXP shares found themselves moving sharply in Wednesday’s premarket hours.

In an unsurprising event, TNXP entered today’s market with over 100%. As of 13:35 GMT, the stock has climbed a hefty 115.90% or $4.772, to trade at $8.93. Shares hit an intraday high of $9.32 not too long after Wednesday’s opening bell.

Moving forward, with the company's ongoing work surrounding TNX-102 SL, and considering the strong Phase 2 results, the Phase 3 trial is expected to be overwhelmingly positive, and will continue moving the stock upwards.

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