VistaGen Therapeutics, Inc. (NASDAQ:VTGN) Files An 8-K Other Events
Item 9.01 Other Events.

VistaGen Therapeutics, Inc. (the “Company”) today announced the initiation of ELEVATE, the Company’s double-blind, placebo-controlled Phase 2 clinical study to evaluate the efficacy and safety of AV-101 (L-4-chlorokynurenine) as an adjunctive treatment of Major Depressive Disorder (“MDD”) in patients with an inadequate response to current antidepressants approved by the U.S. Food and Drug Administration (“FDA”). AV-101, the Company’s oral N-methyl-D-aspartate (“NMDA”) receptor glycine B (“GlyB”) antagonist, belongs to a new generation of investigational medicines in neuropsychiatry known as glutamate receptor modulators that have the potential to treat MDD faster than current FDA-approved antidepressants. A copy of the Company’s press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

See Exhibit Index.

VistaGen Therapeutics, Inc. Exhibit
EX-99.1 2 ex99-1.htm PRESS RELEASE Blueprint     Exhibit 99.1   VistaGen Therapeutics Initiates Phase 2 Study of AV-101 for Major Depressive Disorder   South San Francisco,…
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About VistaGen Therapeutics, Inc. (NASDAQ:VTGN)

VistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in developing and commercializing product candidates for patients with diseases and disorders involving the central nervous system (CNS). Its lead product candidate, AV-101, is an orally available prodrug candidate in Phase II development, initially for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressants approved by the United States Food and Drug Administration (FDA). In addition to AV-101, the Company has developed a human pluripotent stem cell (hPSC) technology platform, which includes its in-vitro bioassay system, CardioSafe 3D, to predict potential heart toxicity of new chemical entities (NCEs) long before testing in animal and human studies. The Company is focused on regenerative medicine (RM) applications using blood, cartilage, heart and/or liver cells derived from hPSCs.