Ajda

FDA Provides Positive Feedback to Vistagen Regarding Use of the Liebowitz Social Anxiety Scale (LSAS) as an Endpoint in Phase 3 Development of Fasedienol (PH94B) for Treatment of Social Anxiety Disorder

Retrieved on: 
Thursday, March 30, 2023
Mental Health, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Columbia University, Depression, Central nervous system, Paroxetine, Sertraline, Liebowitz social anxiety scale, Anxiety, New Drug Application, Fear, Fasedienol, Clinical trial, NDA, SAD, Headache, CNS, New York State Psychiatric Institute, Trial of the century, Hamilton Anxiety Rating Scale, PRN, DSM-IV codes, Disorder, Patient, LSAS, Anxiety disorder, Social anxiety disorder, Principal, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, Nursing, Ajda

“With positive feedback from the FDA, we’re focused on advancing a clinical study design with the Liebowitz Social Anxiety Scale as the primary endpoint to study the real-world effects of fasedienol over time,” said Shawn Singh, Chief Executive Officer of Vistagen.

Key Points: 
  • “With positive feedback from the FDA, we’re focused on advancing a clinical study design with the Liebowitz Social Anxiety Scale as the primary endpoint to study the real-world effects of fasedienol over time,” said Shawn Singh, Chief Executive Officer of Vistagen.
  • “This is an important step forward, especially as SAD is becoming even more prevalent in a post-COVID world.
  • Dr. Liebowitz was among the clinical investigators involved in the registrational efficacy trials for all of these drugs, and all of such registrational trials were positive.
  • Results of the AjDA study may provide support for an as-needed (PRN) fasedienol dosing approach over time as the preferred mode of treatment.

Vistagen Provides Corporate Update and Reports Fiscal 2023 Third Quarter Financial Results

Retrieved on: 
Tuesday, February 7, 2023
Biotechnology, Pharmaceutical, Health, Mental Health, New Drug Application, PIN, Hot, PALISADE, DSM-IV codes, Probenecid, Safety, PH94B, Acquisition, NMDA, SAD, Patient, PH10, Depression, Food, LSAS, CNS, Fear, G&A, Anxiety, Social anxiety disorder, MDD, Liebowitz social anxiety scale, Migraine, FDA, Research, Calendar, Central nervous system, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, COVID-19, Cognition, Fast Track, FTD, R, IND, Pharmaceutical industry, Medical device, Cryptocurrency, Broadcasting, Ajda

“Since our last quarterly update, Vistagen has met several important business objectives,” said Shawn Singh, Chief Executive Officer of Vistagen.

Key Points: 
  • “Since our last quarterly update, Vistagen has met several important business objectives,” said Shawn Singh, Chief Executive Officer of Vistagen.
  • Should Vistagen resume PALISADE-2, the proposed amendments are intended to address various methodological issues believed to have contributed to the unexpected results of PALISADE-1.
  • Vistagen anticipates reporting topline results from this exploratory Phase 2A AjDA trial by the end of the first quarter of calendar 2023.
  • Vistagen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to discuss its financial results for its third quarter fiscal year 2023 ended December 31, 2022 and provide a corporate update.

Vistagen Announces Closing of Pherin Pharmaceuticals Acquisition

Retrieved on: 
Thursday, February 2, 2023
Biotechnology, Pharmaceutical, Health, Mental Health, Additive effect, DSM-IV codes, Drug development, PH94B, Acquisition, SAD, PH10, Depression, Mixed anxiety–depressive disorder, CNS, Anxiety, Social anxiety disorder, MDD, Ajda, Migraine, Central nervous system, Cognition, Hot, Pharmaceutical industry, Pherine

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today announced the closing of its acquisition of Pherin Pharmaceuticals, Inc., a privately held drug development company focused on neuropsychiatric and neuroendocrine conditions (Pherin).

Key Points: 
  • Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today announced the closing of its acquisition of Pherin Pharmaceuticals, Inc., a privately held drug development company focused on neuropsychiatric and neuroendocrine conditions (Pherin).
  • Vistagen’s acquisition of Pherin eliminates all future royalty payment obligations related to its five pherine nasal spray drug candidates.
  • “This acquisition is another important step in our plan to develop and commercialize PH94B and PH10 as innovative treatments for millions of individuals struggling with anxiety and depression disorders,” stated Shawn Singh, Chief Executive Officer of Vistagen.
  • This acquisition significantly improves the potential future commercial profile of each drug candidate.”
    Additional details regarding the closing of Vistagen’ acquisition of Pherin can be found in the Company’s Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission today and available in the Investors section of Vistagen’s website.

Vistagen Announces Completion of Last Patient, Last Visit in Phase 2 Clinical Trial of PH94B for the Treatment of Adjustment Disorder with Anxiety

Retrieved on: 
Tuesday, January 10, 2023
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Principal, New York State Psychiatric Institute, Mental health, Depression, CNS, Anxiety, Safety, Ajda, Health, Hamilton Anxiety Rating Scale, Columbia University, Central nervous system, Prevalence, PH94B, Data analysis, Anxiety disorder, Pharmaceutical industry

The exploratory Phase 2 clinical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled study intended to evaluate efficacy, safety and tolerability of PH94B administered four times per day over four weeks for the treatment adjustment disorder with anxiety symptoms in adults.

Key Points: 
  • The exploratory Phase 2 clinical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled study intended to evaluate efficacy, safety and tolerability of PH94B administered four times per day over four weeks for the treatment adjustment disorder with anxiety symptoms in adults.
  • The primary endpoint is the change from baseline in anxiety level as measured by the Hamilton Anxiety Rating Scale (HAM-A) at the end of Week 4 of treatment with PH94B or placebo.
  • This is a major milestone for our team,” stated Shawn Singh, Chief Executive Officer of Vistagen.
  • Vistagen is dedicated to developing treatments to address the escalating mental health crisis.

Vistagen Advances Intellectual Property Program to Expand Patent Protection for PH94B to Include Treatment of Adjustment Disorder

Retrieved on: 
Friday, December 30, 2022
Biotechnology, Pharmaceutical, Health, Mental Health, Migraine, Anxiety, SAD, Flash, Central nervous system, Facilitated diffusion, MDD, PH94B, Patent, Depression, CNS, Acquisition, Ajda, Cognition, Social anxiety disorder, PH10, Pharmaceutical industry

These new filings are intended to provide a global exclusivity platform for PH94B in AjD, similar to the Company’s patent protection for PH94B for the treatment of social anxiety disorder (SAD), and for its other late-clinical stage product candidate, PH10, for the treatment of major depressive disorder (MDD).

Key Points: 
  • These new filings are intended to provide a global exclusivity platform for PH94B in AjD, similar to the Company’s patent protection for PH94B for the treatment of social anxiety disorder (SAD), and for its other late-clinical stage product candidate, PH10, for the treatment of major depressive disorder (MDD).
  • Vistagen recently announced its pending acquisition of Pherin Pharmaceuticals, Inc.
  • Vistagen will also gain full ownership of three new early clinical-stage pherine product candidates: PH15 for cognition improvement; PH284 for appetite-related disorders and PH80 for migraine and hot flashes.
  • When the acquisition is completed, Vistagen's global patent portfolio for novel pherine class compounds will further expand to include U.S. and foreign counterpart patent applications related to the use of PH80 for the treatment of migraine and for the treatment of hot flashes.

Vistagen to Acquire Pherin Pharmaceuticals

Retrieved on: 
Wednesday, December 21, 2022
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, Migraine, Anxiety, SAD, Flash, Disorder, Central nervous system, MDD, PH94B, Depression, CNS, Acquisition, Patient, Ajda, Cognition, Social anxiety disorder, PH10, Pharmaceutical industry, Pherine

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, and Pherin Pharmaceuticals, Inc., a clinical-stage drug development company focused on the discovery and development of investigational pherine compounds for treatment of neuropsychiatric and neuroendocrine conditions (Pherin), today announced that the companies have entered into a definitive agreement under which Vistagen will acquire Pherin for approximately 12.4 million shares of Vistagen common stock and a nominal amount of cash.

Key Points: 
  • Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, and Pherin Pharmaceuticals, Inc., a clinical-stage drug development company focused on the discovery and development of investigational pherine compounds for treatment of neuropsychiatric and neuroendocrine conditions (Pherin), today announced that the companies have entered into a definitive agreement under which Vistagen will acquire Pherin for approximately 12.4 million shares of Vistagen common stock and a nominal amount of cash.
  • Upon closing of the acquisition, which is subject to certain customary closing conditions, Vistagen will acquire Pherin’s entire pherine pipeline, resulting in Vistagen gaining full ownership of intellectual property rights to its two most advanced drug candidates, PH94B, currently in Phase 3 development for social anxiety disorder (SAD) and Phase 2 development for adjustment disorder with anxiety (AjDA), and PH10, in clinical development for major depressive disorder (MDD).
  • Vistagen will also expand its pipeline with three new early clinical-stage pherine product candidates: PH15 for cognition improvement; PH80 for migraine and hot flashes; and PH284 for appetite-related disorders.
  • “Since 2018, we have observed the experienced Vistagen team working diligently to advance all aspects of development for PH94B and PH10.

Vistagen Reports Second Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, November 10, 2022
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Review, Data analysis, Liebowitz social anxiety scale, PIN, LSAS, NMDA, IND, Risk, Adult, Calendar, Nasal spray, PALISADE, Probenecid, Depression, Central nervous system disease, Food, Nasdaq, Research, Fear, Anxiety, PH94B, COVID-19, Neuron, MDD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, R, Hallucination, SEC, Annual report, Brain, Social anxiety disorder, SAD, Safety, U.S. Securities and Exchange Commission, Time, Company, Grammatical mood, PH10, Clinical trial, Patient, OLS, Therapy, Drug discovery, Hamilton Rating Scale for Depression, Central nervous system, Major depressive disorder, Industry, Decision-making, CNS, FDA, Trial of the century, Pharmaceutical industry, Fine chemical, G&A, Ajda

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (CNS) disorders, today reported financial results for its fiscal year 2023 second quarter ended September 30, 2022 and provided a corporate update.

Key Points: 
  • Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (CNS) disorders, today reported financial results for its fiscal year 2023 second quarter ended September 30, 2022 and provided a corporate update.
  • During the past quarter, Vistagen achieved several important milestones to advance our CNS pipeline.
  • Vistagen anticipates topline results from this exploratory Phase 2A AjDA trial during the first quarter of calendar 2023.
  • Vistagen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to discuss its financial results for its second quarter fiscal year 2023 ended September 30, 2022 and provide a corporate update.

VistaGen Therapeutics Reports First Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, August 11, 2022
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, FDA, U.S. Securities and Exchange Commission, Social anxiety disorder, MDD, Depression, Lists of diseases, Liebowitz social anxiety scale, Probenecid, Subjective units of distress scale, NDA, SUDS, Industry, CNS, Trial of the century, R, PH10, Neuron, Major depressive disorder, SEC, Brain, IND, Social anxiety, Anxiety, Research, Annual report, LSAS, Adjustment disorder, Patient, Therapy, SAD, COVID-19, Company, State, Calendar, Central nervous system disease, Central nervous system, PH94B, Safety, PIN, Risk, Investigational New Drug, Nasdaq, Time, NMDA, PALISADE, Pharmaceutical industry, Fine chemical, G&A, Ajda

Our mission is to transform lives, and we have a strong pipeline and team in place to accomplish that goal, added Singh.

Key Points: 
  • Our mission is to transform lives, and we have a strong pipeline and team in place to accomplish that goal, added Singh.
  • VistaGen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to provide a corporate update and discuss its financial results for its first quarter fiscal year 2023 ended June 30, 2022.
  • VistaGen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety and depression.
  • The Company explicitly disclaims any obligation to update any forward-looking statements, other than as may be required by law.

VistaGen Therapeutics Reports Fiscal Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, June 23, 2022
Mental Health, Health, FDA, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Consensus, Depression, FDA, Biological Psychiatry (journal), Society, Safety, CNS, U.S. Securities and Exchange Commission, NMDA, Disorder, Post-traumatic stress disorder, PH10, MDD, MOA, SAD, Ajda, COVID-19, Brain, Food, Annual general meeting, Therapy, Social anxiety disorder, PTSD, Neuron, G&A, Medscape, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Annual report, Decision-making, Industry, Risk, Consensus decision-making, Central nervous system disease, PALISADE, IND, Marketing, Mental health, Nasdaq, HAP, PIN, Lists of diseases, Central nervous system, Anxiety, SEC, State, R, Â, Time, Research, PH94B, Probenecid, Company, ASCP, NDA, Drug development, Investigational New Drug, Pharmaceutical industry, Online gambling

VistaGen Therapeutics, Inc. (Nasdaq: VTGN), a late clinical-stage, central nervous system (CNS)-focused biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders, today reported its financial results for its fiscal year ended March 31, 2022 and provided a corporate update.

Key Points: 
  • VistaGen Therapeutics, Inc. (Nasdaq: VTGN), a late clinical-stage, central nervous system (CNS)-focused biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders, today reported its financial results for its fiscal year ended March 31, 2022 and provided a corporate update.
  • VistaGen continued consistent progress across its nasal spray, pherine-based platform and novel oral NMDA (N-methyl-D-aspartate) receptor programs.
  • VistaGen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to provide a corporate update and discuss its financial results for its fiscal year 2022 ended March 31, 2022.
  • The Company explicitly disclaims any obligation to update any forward-looking statements, other than as may be required by law.

VistaGen to Present PH94B Exploratory Phase 2A Research Program for Adjustment Disorder with Anxiety at American Society for Clinical Psychopharmacology Annual Meeting

Retrieved on: 
Thursday, June 2, 2022
Mental Health, Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Benzodiazepine, Panic disorder, PTSD, Company, Research, Society, Anxiety, Marketing, Food, Central nervous system, Depression, Annual report, Pharmacist, Neuron, ASCP, PH94B, NIH, Annual general meeting, Nasdaq, Solution, Psychopharmacology, U.S. Securities and Exchange Commission, SAD, Divorce, Therapy, FDA, Brain, National, Central nervous system disease, Patient, Fast Track, Risk, PALISADE, Ajda, COVID-19, Social anxiety disorder, MOA, SEC, Prevalence, Clinical trial, Pharmacogenomics, Industry, Disorder, Psychiatry, Food and Drug Administration, CNS, Fear, Safety, Pharmaceutical industry

VistaGen is also currently evaluating PH94B in the Companys two PALISADE Phase 3 clinical trials for the acute treatment of anxiety in adults with social anxiety disorder (SAD).

Key Points: 
  • VistaGen is also currently evaluating PH94B in the Companys two PALISADE Phase 3 clinical trials for the acute treatment of anxiety in adults with social anxiety disorder (SAD).
  • There is significant demand and need for treatments for anxiety disorders, including adjustment disorder.
  • At this important moment and amid this significant unmet need, we look forward to sharing our clinical trial abstract with top psychopharmacology leaders in attendance at the ASCP Annual Meeting."
  • In addition to SAD, for which the FDA has granted Fast Track designation, PH94B may have potential in adjustment disorder with anxiety, procedural anxiety, PTSD, postpartum anxiety and panic disorder.