VistaGen Therapeutics, Inc. (NASDAQ:VTGN) Files An 8-K Other EventsItem 8.01 Other Events.
VistaGen Therapeutics, Inc. (the “Company”) today announced that the U.S. Food and Drug Administration has authorized the Company to proceed, under its Investigational New Drug application, with its planned Phase 2 clinical study of AV-101 as a new generation oral treatment for major depressive disorder. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1, and is incorporated herein by reference.
Item 9.01 Exhibits.
See Exhibit Index.
VistaGen Therapeutics, Inc. ExhibitEX-99.1 2 ex99-1.htm PRESS RELEASE Blueprint Exhibit 99.1 VistaGen Announces FDA Authorization to Initiate Phase 2 Study of AV-101 for Major Depressive Disorder South San Francisco,…To view the full exhibit click here
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.
