Tonix Pharmaceuticals Holding Corp (TNXP)

[MOCKBA]

NEW YORK, April 22, 2019 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company developing pharmaceutical products to treat psychiatric and pain conditions, and biological products to improve biodefense, today announced the U.S. Food and Drug Administration (FDA) has withdrawn its previously issued Breakthrough Therapy Designation Rescind letter and confirmed that the Breakthrough Therapy designation granted in December 2016 remains in effect for Tonmya* (cyclobenzaprine HCl sublingual tablets) for the treatment of posttraumatic stress disorder (PTSD), which is in Phase 3 development.  Tonix also announced that FDA has reversed itself and granted the Company a meeting in June to present additional data to support continuing Breakthrough Therapy designation.?