On August 6, 2020, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced that the U.S. Food and Drug Administration cleared the Investigational New Drug application for the initiation of a Phase 2 proof-of-concept study using TNX-102 SL for treatment of alcohol use disorder. A copy of the press release discussing this matter is filed as Exhibit 99.01, and incorporated by reference in, this report.
* TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.
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