LSAS

Subsequent to the Release of Positive Phase 3 Trial Results, Vistagen Provides Corporate Update and Reports Fiscal 2024 First Quarter Financial Results

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목요일, 8월 10, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Neuron, Hot, Optimism, Central nervous system, Depression, Nasal cavity, Anxiety, Aes, New Drug Application, Food and Drug Administration, Calendar, Clinical Global Impression, NDA, Woman, Subjective units of distress scale, SAD, Liebowitz social anxiety scale, Multimedia, Brain, CNS, Trial of the century, Visit, PALISADE, MDD, Patient, LSAS, Menopause, Social anxiety disorder, FDA, Fasedienol, Safety, Pharmaceutical industry, Nursing, Medical imaging, Dietary supplement, SUDS

Phase 3 study of an investigational therapy for social anxiety disorder in over 15 years,” said Shawn Singh, Chief Executive Officer of Vistagen.

Key Points: 
  • Phase 3 study of an investigational therapy for social anxiety disorder in over 15 years,” said Shawn Singh, Chief Executive Officer of Vistagen.
  • Positive Phase 3 PALISADE-2 study of fasedienol yields statistically significant top-line results for the acute treatment of anxiety in adults with SAD.
  • Based on the positive top-line results of the Phase 3 PALISADE-2 study, we are currently preparing for our Phase 3 PALISADE-3 trial, with potential to initiate the trial during the first half of calendar 2024.
  • Vistagen will host a conference call and live audio webcast this afternoon at 4:30 p.m. Eastern Time to provide a corporate update.

Vistagen Announces Positive Top-Line Results from Phase 3 PALISADE-2 Trial of Fasedienol (PH94B) Nasal Spray in Social Anxiety Disorder

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월요일, 8월 7, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Columbia University, Depression, Central nervous system, Liebowitz social anxiety scale, Anxiety, Aes, SAD, Medicine, CNS, New York State Psychiatric Institute, Visit, Patient, LSAS, Anxiety disorder, Social anxiety disorder, PH94B, Social anxiety, Fasedienol, Safety, Pharmaceutical industry, Nursing, Medical imaging, SUDS

The trial met its primary endpoint, with fasedienol demonstrating a statistically significant difference in average SUDS score during a public speaking challenge compared to placebo (p=0.015).

Key Points: 
  • The trial met its primary endpoint, with fasedienol demonstrating a statistically significant difference in average SUDS score during a public speaking challenge compared to placebo (p=0.015).
  • The trial also met its secondary endpoint, demonstrating a statistically significant difference in the proportion of clinician-assessed responders between fasedienol and placebo as measured by the CGI-I scale (p=0.033).
  • Fasedienol was well-tolerated and demonstrated a favorable safety profile consistent with all prior trials.
  • “As a new class of medicines, our pherine nasal spray pipeline holds the potential to transform the treatment landscape across numerous therapeutic areas.

Vistagen Provides Corporate Update and Reports Fiscal Year 2023 Financial Results

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수요일, 6월 28, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Columbia University, Hot, Depression, Central nervous system, Liebowitz social anxiety scale, Anxiety, New Drug Application, COVID-19, Fear, Calendar, NDA, Woman, SAD, Fast Track, CNS, New York State Psychiatric Institute, Science, Phase 1, PALISADE, MDD, PH10, Patient, LSAS, Anxiety disorder, Menopause, Principal, PH94B, FDA, Safety, Pharmaceutical industry

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 provided a corporate update and reported financial results for its fiscal year 2023 ended March 31, 2023.

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 provided a corporate update and reported financial results for its fiscal year 2023 ended March 31, 2023.
  • Positive results reported from Phase 2A study of PH80 in women diagnosed with vasomotor symptoms (hot flashes) due to menopause.
  • Vistagen will host a conference call and live audio webcast this afternoon at 4:30 p.m. Eastern Time to provide a corporate update for its fiscal year 2023 ended March 31, 2023.
  • In addition, a telephone playback of the call will be available after approximately 8:00 p.m. Eastern Time on Wednesday, June 28, 2023.

Vistagen Presents Fasedienol (PH94B) Safety and Exploratory Efficacy Data from Phase 3 Open-Label Social Anxiety Disorder Study at American Society for Clinical Psychopharmacology Annual Meeting

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목요일, 6월 1, 2023
Mental Health, FDA, Public Relations, Investor Relations, Communications, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Central nervous system, Depression, Anxiety, COVID-19, Fear, Woman, SAD, Headache, CNS, ASCP, Patient, LSAS, Annual general meeting, Social anxiety disorder, Poster, PH94B, Mental health, Society, Safety, Pharmaceutical industry, Nursing, Medical imaging

Over 30,000 doses of fasedienol were administered by patients during the study.

Key Points: 
  • Over 30,000 doses of fasedienol were administered by patients during the study.
  • The LSAS was the primary efficacy endpoint in all registration studies for the three FDA-approved treatments for adults with SAD.
  • The CGI-I results indicated 43% of the 218 patients assessed after three months were “much” or “very much” improved.
  • The PGI-C results indicated 44% of the 218 patients assessed after three months considered themselves “much” or “very much” improved.

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

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목요일, 3월 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.

Clinical Trial of Arcade Therapeutics' Flagship Therapeutic Mobile Game, StarStarter Rx, Shows Robust Reductions in Social Anxiety in Adults

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목요일, 3월 23, 2023
Arcade, Liebowitz social anxiety scale, Anxiety, Policy, COVID-19, SAD, Document Number Nine, Document, DSM-IV codes, Food and Drug Administration Amendments Act of 2007, Patient, Beck Depression Inventory, LSAS, Social anxiety disorder, Generalized anxiety disorder, Beck, FDA, Therapy, Social anxiety, Food, Safety, Nursing, Pharmaceutical industry

Arcade's clinical research uses a gold-standard placebo sham in research studies that isolates and controls for the therapy's mechanism of action.

Key Points: 
  • Arcade's clinical research uses a gold-standard placebo sham in research studies that isolates and controls for the therapy's mechanism of action.
  • "We are thrilled by these promising results as we continue down the path toward FDA submission of StarStarter Rx as the first game-based treatment for Social Anxiety Disorder."
  • StarStarter Rx is available with the Arcade Connect DTx deployment platform, which includes integration features, clinical assessments, and HIPAA-consent management.
  • StarStarter Rx is not intended for use as a standalone therapy and does not represent a substitution for your medication.

Vistagen Announces Positive Data in Fasedienol (PH94B) Phase 3 Open-Label Study in Adults with Social Anxiety Disorder

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수요일, 3월 22, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Central nervous system, Depression, Anxiety, Safety, Overalls, COVID-19, Aes, Fear, Liebowitz social anxiety scale, SAD, Headache, CNS, Selective serotonin reuptake inhibitor, Patient, LSAS, Social anxiety disorder, SNRI, PH94B, FDA, Wireless ambulatory ECG, Pharmaceutical industry

Secondary endpoints in the study included evaluation of the change from baseline on the Liebowitz Social Anxiety Scale (LSAS), which measures SAD patients’ response to anxiety-provoking social and performance situations experienced in their daily lives.

Key Points: 
  • Secondary endpoints in the study included evaluation of the change from baseline on the Liebowitz Social Anxiety Scale (LSAS), which measures SAD patients’ response to anxiety-provoking social and performance situations experienced in their daily lives.
  • The safety and exploratory LSAS results of this Phase 3 open label study build on the safety and LSAS efficacy results from a previous randomized, double-blind, placebo-controlled Phase 2 study of fasedienol in a real-world setting.
  • All prior registration studies for these medications were positive, and all studies used the LSAS as the primary efficacy endpoint.
  • At the time of study closure, study participants had a mean trial exposure of 120 days and a maximum exposure of 320 days.

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

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화요일, 2월 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 Reports Second Quarter Financial Results and Provides Corporate Update

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목요일, 11월 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

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목요일, 8월 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.