VistaGen (VTGN) announces disappointing results from the ELEVATE study on MDD candidate, AV-101.

Sage Therapeutics' (SAGE) phase III study on pipeline candidate SAGE-217 for the treatment of major depressive disorder fails to meet the primary endpoint.

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We can readily understand why investors are attracted to unprofitable companies. For example, although Amazon.com made...

SOUTH SAN FRANCISCO, Calif. , Nov. 7, 2019 /PRNewswire/ --  VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system ...

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.

VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for development of the Company's PH94B neuroactive nasal spray for on-demand treatment of social anxiety disorder (SAD).

SOUTH SAN FRANCISCO, Calif., Nov. 14, 2019 /PRNewswire/ -- VistaGen Therapeutics (VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, today announced topline results from the ELEVATE study, a Phase 2 study of AV-101, its NMDA (N-methyl-D-aspartate) receptor glycine site antagonist, as an adjunctive treatment of major depressive disorder (MDD). In this study, the AV-101 treatment arm did not differentiate from placebo on the primary endpoint (change in the Montgomery-Åsberg Depression Rating Scale (MADRS-10) total score compared to baseline). As in prior clinical studies, AV-101 was well tolerated, with no psychotomimetic side effects or serious adverse events.

VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for anxiety, depression and central nervous system (CNS) diseases and disorders with high unmet medical need, today announced a common stock purchase agreement with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor, providing for up to $10.25 million.

The FDA assigns a Fast Track status to VistaGen's (VTGN) neuroactive nasal spray PH94B for the on-demand treatment of social anxiety disorder. Stock surges.

VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system (CNS) diseases and disorders with high unmet medical need, today announced plans to expand clinical development of PH94B, its first-in-class rapid-onset neuroactive nasal spray, to include treatment of adjustment disorder due to stressors related to the COVID-19 pandemic. Adjustment disorder is an emotional or behavioral reaction considered excessive or out of proportion to a stressful event or major life change, occurring within three months of the stressor, and/or significantly impairing a person's social, occupational and/or other important areas of functioning.

While initial public offerings get most of the splash, public companies also are raking in cash with follow-on offerings. How long will the Wall Street spigot stay open?

VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for anxiety and depression, as well as certain central nervous system (CNS) diseases and disorders with high unmet medical need, today announced that the Company has submitted its proposed protocol for a Phase 2A study of PH94B, its investigational anti-anxiety drug, for treatment of adjustment disorder with anxiety related to the COVID-19 pandemic to the U.S. Food and Drug Administration (FDA) through the FDA's new Coronavirus Treatment Acceleration Program (CTAP). Adjustment disorder is an emotional or behavioral reaction considered excessive or disproportionate to a stressful event or major life change, occurring within three months of the stressor, and/or significantly impairing a person's social, occupational and/or other important areas of functioning.

SOUTH SAN FRANCISCO, Calif., Oct. 28, 2019 /PRNewswire/ -- VistaGen Therapeutics (VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, today announced that the European Patent Office (EPO) has granted the Company a second patent for therapeutic uses of AV-101, its oral NMDA (N-methyl-D-aspartate) receptor glycine site antagonist. The new patent expands the set of claims relating to treatment of depression and dyskinesia (involuntary or diminished voluntary muscle movements) associated with levodopa therapy for Parkinson's disease. AV-101 (4-Cl-KYN) belongs to a new generation of investigational medicines in neuropsychiatry and neurology known as NMDA receptor modulators.

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 positive results from a newly published exploratory Phase 2a clinical study of PH10, its investigational first-in-class, rapid-onset synthetic neurosteroid nasal spray, for treatment of major depressive disorder (MDD). Results of the double-blind, randomized, placebo-controlled Phase 2a study have been published in the peer-reviewed British Journal of Pharmaceutical and Medical Research.

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 that its Investigational New Drug (IND) application for AV-101, the Company's oral NMDAR (N-methyl-D-aspartate receptor) glycine site antagonist, as a potential treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy has been cleared by the U.S. Food and Drug Administration (FDA). The FDA's IND clearance permits VistaGen to proceed with Phase 2 clinical development of AV-101 in this indication. The Company also announced that 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 Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system (CNS) diseases and disorders with high unmet need, and Nuformix plc (LSE: NFX.L), a pharmaceutical development company focused on unlocking the therapeutic potential and value of known drugs, today announced their agreement to develop novel cocrystal-based formulations of VistaGen's CNS product candidates. Under the terms of the agreement, VistaGen and Nuformix initially will apply Nuformix's proprietary technology platform to develop patentable new crystalline forms of AV-101 that may have superior delivery, an enhanced therapeutic profile and additional intellectual property protection. If successful, VistaGen and Nuformix will consider opportunities to extend the collaboration to other CNS therapeutic candidates with a view to unlocking additional therapeutic and commercial opportunities.

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 positive preclinical data of AV-101, an oral NMDAR (N-methyl-D-aspartate receptor) antagonist prodrug, administered in combination with probenecid. The new preclinical data suggest that there is a substantially increased brain concentration of AV-101 and its active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), when given together with probenecid. These surprising effects were first revealed in the Company's recent preclinical study, although they are consistent with well-documented clinical studies of probenecid increasing the therapeutic levels of several unrelated classes of approved drugs.

Key highlights of the past week include regulatory and pipeline updates along with collaboration deals.

VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, and Baylor College of Medicine (Baylor), today announced successful results from a first-step, Phase 1b clinical study with healthy U.S. military Veterans, which measured NMDAR (N-methyl-D-aspartate receptor) target engagement of VistaGen's investigational product candidate, AV-101, an oral NMDAR glycine site antagonist, 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 Receptor Engagement of Kynurenine Pathway Modulator AV-101 in Healthy Veterans," at the 2019 Annual Meeting of the American College of Neuropsychopharmacology (ACNP) on December 11, 2019.