VistaGen Therapeutics Inc
NASDAQ:VTGN
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VistaGen Therapeutics Inc
VistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical company committed to developing and commercializing new generation medications that go beyond the current standard of care for anxiety, depression, and other central nervous system (CNS) disorders. The company is headquartered in South San Francisco, California and currently employs 31 full-time employees. The company went IPO on 2010-10-18. The firm is engaged in developing and commercializing product candidates for patients with diseases and disorders involving the central nervous system (CNS). The firm's pipeline includes PH94B, a neuroactive nasal spray with potential to treat multiple anxiety disorders that is preparing for Phase III clinical trial for social anxiety disorder (SAD), PH10, a neuroactive nasal spray that is planning for Phase 2b development as a stand-alone treatment for depressive disorder (MDD), and AV-101 which the Company is developing for the treatment of depressive disorder (MDD), suicidal ideation, neuropathic pain, levodopa-induced dyskinesia (LID) and epilepsy. In addition, the Company has developed a human pluripotent stem cell (hPSC) technology platform, CardioSafe 3D, to predict potential heart toxicity of new chemical entities (NCEs).
VistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical company committed to developing and commercializing new generation medications that go beyond the current standard of care for anxiety, depression, and other central nervous system (CNS) disorders. The company is headquartered in South San Francisco, California and currently employs 31 full-time employees. The company went IPO on 2010-10-18. The firm is engaged in developing and commercializing product candidates for patients with diseases and disorders involving the central nervous system (CNS). The firm's pipeline includes PH94B, a neuroactive nasal spray with potential to treat multiple anxiety disorders that is preparing for Phase III clinical trial for social anxiety disorder (SAD), PH10, a neuroactive nasal spray that is planning for Phase 2b development as a stand-alone treatment for depressive disorder (MDD), and AV-101 which the Company is developing for the treatment of depressive disorder (MDD), suicidal ideation, neuropathic pain, levodopa-induced dyskinesia (LID) and epilepsy. In addition, the Company has developed a human pluripotent stem cell (hPSC) technology platform, CardioSafe 3D, to predict potential heart toxicity of new chemical entities (NCEs).
PALISADE-3 Completed: The company completed the randomized portion of its PALISADE-3 Phase III trial for social anxiety disorder and is using results to refine ongoing PALISADE-4 execution.
Data Analysis & AI: Vistagen is partnering with external groups to use AI and machine learning on PALISADE trial data to better understand drug and placebo responses.
Operational Improvements: Moderate refinements like site retraining and operational enhancements were implemented for PALISADE-4 to address high placebo response seen in PALISADE-3.
Women's Health Pipeline: The women's health candidate, now named refisolone (PH80), received USAN designation, and IND submission is planned for the first half of 2026.
Financial Position: Vistagen ended the quarter with $61.8 million in cash, cash equivalents, and marketable securities, and implemented cash preservation measures.
Regulatory Path: The company intends to use the totality of evidence from all PALISADE studies to support a potential new drug application, with regulatory strategy focused on data integration.
Enrollment On Track: Enrollment for PALISADE-4 is proceeding as planned without disruption following recent announcements.
