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March 31, 2014
09:22 EDTTNXPTonix Pharmaceuticals reports Q4 EPS (74c), one estimate (46c)
Seth Lederman, M.D., president and CEO of Tonix stated, "In Q4, Tonix continued to make steady progress in the BESTFIT trial of TNX-102 SL in fibromyalgia, and we began an open-label extension study of trial completers. As recruitment has proceeded ahead of our projections, we plan to stop enrollment at approximately 200 subjects, which is the upper end of the original sample size. We anticipate reporting top-line results of BESTFIT in the fourth quarter of this year. On March 26, the FDA held a public meeting on Patient-Focused Drug Development for fibromyalgia. FDA's decision to hold this meeting, and the robust patient response to it, further validate our belief that fibromyalgia is a significant and growing medical concern among the U.S. population."
News For TNXP From The Last 14 Days
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May 20, 2015
09:42 EDTTNXPTonix Pharmaceuticals management to meet with Roth Capital
Meeting to be held in Boston on May 27 hosted by Roth Capital.
May 13, 2015
06:05 EDTTNXPTonix Pharmaceuticals launches Phase 3 clinical study of fibromyalgia candidate
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May 11, 2015
06:08 EDTTNXPTonix Pharmaceuticals on track to complete two clinical studies this quarter
Tonix Pharmaceuticals chairman and CEO, Seth Lederman, M.D., stated, "Our experienced development team has made significant progress over the past several months, which included obtaining FDA agreement on the acceptable primary endpoint for our Phase 3 fibromyalgia study as well as input on our Phase 2 proof-of-concept tension headache study design. Our successful preparation paves the way for several prominent milestones in our portfolio of drug candidates for central nervous system disorders. We are very excited about the upcoming initiation of our Phase 3 fibromyalgia study of TNX-102 SL. In addition, our Phase 2 study of TNX-102 SL in military-related post-traumatic stress disorder, or PTSD, is progressing as expected. Our Phase 2 proof-of-concept study of TNX-201 in episodic tension-type headache is on track to start this quarter, and from which we expect to report top-line data in Q4. Having three large, adequate, and well-controlled clinical studies in high-value therapeutic indications simultaneously ongoing validates our business model of developing next generation medicines for significant unmet needs in a capital-efficient manner."
06:06 EDTTNXPTonix Pharmaceuticals reports Q1 EPS (71c), consensus (54c)

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