Business
VistaGen Therapeutics Reports Fiscal 2020 Third Quarter Financial Results and Provides CNS Pipeline Overview
SOUTH SAN FRANCISCO, Calif., Feb. 13, 2020 /PRNewswire/ -- VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., Feb. 13, 2020 /PRNewswire/ -- VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet medical need, today announced financial results for its fiscal year 2020 third quarter ended December 31, 2019. \n\n \n \n\n \nVistaGen has a multi-asset, clinical-stage CNS pipeline, including three differentiated drug candidates, two of which, PH94B and PH10, have positive human clinical data in individuals with social anxiety disorder (SAD) and major depressive disorder (MDD), respectively, and one of which, PH94B, is in preparation to advance into Phase 3 clinical development for the treatment of SAD by the end of this calendar year. Each of VistaGen's CNS product candidates has an exceptional safety profile, potential for rapid-onset therapeutic benefits, and multiple shots on goal in CNS markets where current treatments are inadequate, resulting in high unmet medical need. \nRecent CNS Pipeline Updates:\nThe U.S. Food and Drug Administration (FDA) has granted Fast Track designation for development of VistaGen's most advanced drug candidate, PH94B neuroactive nasal spray for on-demand treatment of SAD, the first such designation granted by the FDA for development of a drug candidate for SAD. VistaGen's Investigational New Drug (IND) application for AV-101, its oral NMDAR (N-methyl-D-aspartate receptor) antagonist prodrug, as a potential new treatment of dyskinesia in patients with Parkinson's disease receiving levodopa therapy, has been cleared by the FDA, permitting VistaGen to proceed with Phase 2a clinical development of AV-101 in this indication. The U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application 16/003,816 related to therapeutic use of AV-101 for treatment of dyskinesia induced by the administration of levodopa. The patent, once issued, will be in effect until at least 2034. VistaGen announced successful results from an AV-101 first-step, Phase 1b clinical study with healthy U.S. military Veterans, which measured NMDAR target engagement of AV-101 for potential treatment of suicidal ideation in Veterans. The findings from the study were presented in a poster, titled \"Evoked and Resting State Gamma Mechanics to Test NMDA R...