Is This the Beginning of the End for Tonix Pharma?

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Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) led bears in Tuesday’s trading session following the release of top-line results from a Phase 2 clinical study. Basically, the company announced top-line results for its proof-of-concept clinical study of TNX-201 (dexisometheptene mucate) in episodic tension-type headache.

Needless to say, investors were not happy with these results. In 2016 alone, this stock has taken a beating, and unless this company can turn itself around in the near future, it could be the end.

Looking at the preliminary analysis of the results, Tonix determined that the study did not achieve its primary efficacy endpoint of participants achieving headache pain-free status at two hours after dosing.

At the same time, the study also did not achieve two other primary endpoints, which were the proportion of participants with at least a 70% reduction in pain from baseline on the Visual Analog Scale (VAS) at two hours after dosing, and an increase of the mean change from baseline to two hours post-dose in the VAS score.

On somewhat of a positive note, no serious adverse events were reported throughout the duration of the study. There were no treatment emergent adverse event categories reported by more than one participant (1.4%) in either treatment group during the double-blinded treatment period.


Seth Lederman, M.D., president and CEO of Tonix, commented on the results:

These results are disappointing, but we designed the study to challenge our hypothesis rapidly and with minimal capital investment. We are satisfied that we achieved a definitive outcome. We are excited to continue the rigorous execution of our registration-quality Phase 2 study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in post-traumatic stress disorder, as well as our flagship development program, a Phase 3 trial in fibromyalgia of TonmyaÔ (TNX-102 SL, cyclobenzaprine HCl sublingual tablets, 2.8 mg). We look forward to reporting data from these studies, planned for the second and third quarters this year, respectively.

So far in 2016, Tonix has underperformed the market, with the stock down by nearly 50% year to date. Over the course of the past 52 weeks, the stock has performed only slightly better, with shares down only 30%. Also these moves are not taking into account how shares have responded on Tuesday, so really the numbers are even worse.

Shares of Tonix were last seen down 38% at $2.51, with a consensus analyst price target of $13.75 and a new 52-week trading range of $2.48 to $10.72.