Business
VistaGen Therapeutics Reports Fiscal 2021 Second Quarter Financial Results and Provides Highlights on its CNS Pipeline and Business Progress
Positive FDA Meeting Sets Key Pathway for Pivotal PH94B Phase 3 Study in the Second Quarter of 2021 Received Over $17.5 Million Net Proceeds from PH94B
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"Positive FDA Meeting Sets Key Pathway for Pivotal PH94B Phase 3 Study in the Second Quarter of 2021\n Received Over $17.5 Million Net Proceeds from PH94B Upfront License Payment and Public Offering of Common Stock\n Positive New Data from Second Preclinical Study of AV-101 in Combination with Probenecid\n Positive Preclinical Data Differentiating Mechanism of Action of PH94B from Risk-Ridden Benzodiazepines\n\n\nSOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 /PRNewswire/ -- VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system (CNS) disorders, today reported its financial results for the fiscal 2021 second quarter ended September 30, 2020 and provided an update on its CNS pipeline and business progress.\n\n \n \n \n \n \n \n\n \n\"We see a significant rise in mental health concerns as the global COVID-19 pandemic continues to impact the daily lives of millions of individuals. We are committed to developing innovative therapies that provide relief to those suffering from anxiety and depression, and we are working diligently towards that goal. We are making significant progress in preparing PH94B for launch of a pivotal Phase 3 study for acute treatment of anxiety in adults with social anxiety disorder in the second quarter of 2021. After reaching consensus with the FDA on the key components of the study design, it will be very similar to the statistically significant Phase 2 study of PH94B in social anxiety disorder. We are also working with the FDA to finalize details for our Phase 2A study of PH94B in adjustment disorder, which we are planning to initiate in early 2021,\" said Shawn Singh, Chief Executive Officer of VistaGen.\n\"Millions of people rely on benzodiazepines and other prescription drugs to manage symptoms of stress and anxiety. While some medications are safe and effective treatments, many in the current treatment paradigm have limited therapeutic benefits and potentially serious side effects and safety concerns. In Phase 2 clinical studies, PH94B produced rapid onset anti-anxiety effects without requiring systemic uptake and distribution. With its rapid-onset pharmacology, lack of systemic exposure and sedation, and its excellent safety profile in all studies to date, we believe PH94B has the potential to displace ...