VistaGen Therapeutics, Inc. (NASDAQ:VTGN) Files An 8-K Other Events
Item 8.01 Other Events.

On October 3, 2018, the Company announced that the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for development of AV-101 as a non-opioid, non-sedating treatment for neuropathic pain, the second FDA Fast Track designation granted to the Company for development of AV-101 since December 2017. 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.

(d) Exhibits Index

Disclaimer.

This Current Report on Form 8-K may contain, among other things, certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, (i) statements with respect to the Company's plans, objectives, expectations and intentions; and (ii) other statements identified by words such as "may", "could", "would", should", "believes", "expects", "anticipates", "estimates", "intends", "plans" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties.

VistaGen Therapeutics, Inc. Exhibit
EX-99.1 2 ex99-1.htm PRESS RELEASE Blueprint   Exhibit 99.1 VistaGen Therapeutics Receives FDA Fast Track Designation for Development of AV-101 as a Non-Opioid Treatment for Neuropathic Pain   Designation highlights serious unmet need for new treatment options for patients suffering from neuropathic pain   Second FDA Fast Track designation for AV-101 since December 2017 marks another milestone for VistaGen’s R&D pipeline   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.