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FDA grants breakthrough therapy designation to Tonix Pharmaceuticals’ TNX-102 SL for the treatment of PTSD; shares up 41% premarket

  • Tonix Pharmaceuticals (NASDAQ:TNXP) announces that the FDA has granted Breakthrough Therapy designation to TNX-102 SL for the treatment of posttraumatic stress disorder (PTSD).
  • The benefits of Breakthrough Therapy designation include the eligibility for priority review of the New Drug Application (NDA) within six months instead of ten months and rolling submission of portions of the NDA, in addition to an organizational commitment involving FDA's senior managers contributing significant guidance.
  • Tonix held a successful End-of-Phase 2/Pre-Phase 3 meeting with the FDA in the Q3 2016, based on positive data from its 12-week randomized, double-blind, placebo-controlled Phase 2 AtEase study.  Tonix plans to begin enrolling patients into its first Phase 3 study, the HONOR study, in Q1 2017 after receiving FDA agreement on the study design and interim analysis plan.
  • TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an Investigational New Drug and has not been approved for any indication.
  • The FDA's Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned for use to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
  • Shares are up 41% premarket on robust volume.

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Tonix Pharmaceuticals Holding Corp.