Tonix Pharmaceuticals Holding Corp. (TNXP) said Monday that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for TNX-102 SL for the treatment of major depressive disorder (MDD) in adults.
The IND clearance allows the company to advance to the potentially pivotal Phase 2 HORIZON study, which will evaluate TNX-102 SL as a first-line monotherapy in adults with MDD.
Tonix Pharmaceuticals shares were down more than 2% in pre-market trading after closing at$16.10, up 2.94% on Friday.
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