Articles from Vistagen

Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced it will host a conference call and webcast on Thursday, February 13, 2025 at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to report results for its fiscal year 2025 third quarter ended December 31, 2024, and provide a corporate update.

Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders, today announced that the U.S. Patent and Trademark Office (USPTO) granted a patent to the Company for its oral non-opioid product candidate, AV-101, for the treatment of neuropathic pain. The patent will not expire until at least 2034 and is part of Vistagen’s global patent portfolio on manufacturing methods and therapeutic uses for AV-101 to treat various disorders involving the NMDA receptor.

Vistagen (Nasdaq: VTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today announced positive results from an exploratory Phase 2A study of PH284 in cancer cachexia. PH284 is an investigational pherine nasal spray differentiated from all current treatments for the loss of appetite associated with chronic disorders, such as cancer. In the study, PH284 demonstrated higher mean subjective feeling of hunger as compared to placebo and appeared safe and well-tolerated with an adverse event profile similar to placebo in a population compromised by terminal cancer.

Vistagen (Nasdaq: VTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today announced enrollment of the first subject in a repeat dose study of fasedienol, its investigational neuroactive pherine nasal spray in Phase 3 development for the acute treatment of social anxiety disorder (SAD).

Vistagen (Nasdaq: VTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today announced that company management will present and host one-on-one meetings during the Stifel 2024 Healthcare Conference taking place November 18 and 19, 2024 in New York City.

Vistagen (Nasdaq: VTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today reported financial results for its fiscal year 2025 second quarter ended September 30, 2024, and provided a corporate update.

Vistagen (Nasdaq: VTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today announced that it will present posters highlighting new prevalence data for social anxiety disorder (SAD), an indication for which fasedienol, its lead intranasal pherine product candidate, is in U.S. registration-directed Phase 3 development for the acute treatment of the disorder, and two additional non-systemic intranasal pherine product candidates in its neuroscience pipeline, itruvone in Phase 2 development for major depressive disorder and hormone-free PH80 in Phase 2 development for the management of vasomotor symptoms (hot flashes) due to menopause, at the 2024 Neuroscience Education Institute (NEI) Congress in Colorado Springs, Colorado from November 7 to 10, 2024.

Vistagen (NASDAQVTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today announced it will host a conference call and webcast on Thursday, November 7, 2024, at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to report results for its fiscal year 2025 second quarter ended September 30, 2024, and provide a corporate update.

Vistagen (Nasdaq: VTGN), a late clinical-stage neuroscience-focused biopharmaceutical company dedicated to the development of groundbreaking therapies for psychiatric disorders based on nose-to-brain neurocircuitry, and The Goldie Hawn Foundation’s MindUP, a neuroscience-based preventative mental health program for youth, along with children from New York City schools utilizing MindUP, will join together in New York City on October 10, 2024 to ring the Nasdaq Closing Bell in honor of World Mental Health Day and The Goldie Hawn Foundation’s 20th Anniversary.

Vistagen (Nasdaq: VTGN) a late clinical-stage neuroscience-focused biopharmaceutical company dedicated to the development and commercialization of groundbreaking therapies for psychiatric and neurological disorders based on nose-to-brain neurocircuitry, today announced enrollment of the first subject in its PALISADE-4 Phase 3 trial of fasedienol, an investigational neuroactive pherine nasal spray in U.S. registration-directed Phase 3 development for the acute treatment of social anxiety disorder (SAD).

Vistagen (Nasdaq: VTGN), a late clinical-stage neuroscience-focused biopharmaceutical company dedicated to the development and commercialization of groundbreaking therapies for psychiatric and neurological disorders based on nose-to-brain neurocircuitry, today reported financial results for its fiscal year 2025 first quarter ended June 30, 2024, and provided a corporate update.

Vistagen (NASDAQVTGN), a late clinical-stage neuroscience-focused biopharmaceutical company dedicated to the development and commercialization of groundbreaking therapies for psychiatric and neurological disorders based on nose-to-brain neurocircuitry, today announced it will host a conference call and webcast on Tuesday, August 13, 2024, at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to report results for its fiscal year 2025 first quarter ended June 30, 2024 and provide a corporate update.

Vistagen (Nasdaq: VTGN), a clinical-stage neuroscience-focused biopharmaceutical company dedicated to the development and commercialization of groundbreaking therapies for psychiatric and neurological disorders based on nose-to-brain neurocircuitry, today announced the broadening of its global intellectual property portfolio after receiving multiple new patents related to the use of PH80 for the treatment of migraine. PH80 is a non-systemic, hormone-free investigational pherine nasal spray in development as a rapid-onset treatment for vasomotor symptoms (hot flashes) due to menopause, with the potential to also treat premenstrual dysphoric disorder, dysmenorrhea, and migraine.

Vistagen (Nasdaq: VTGN), a clinical-stage neuroscience-focused biopharmaceutical company dedicated to the development and commercialization of groundbreaking therapies for psychiatric and neurological disorders based on nose-to-brain neurocircuitry, announced today that for the second consecutive year it has been recognized by Mental Health America (MHA) for its dedication to promoting mental health and well-being in the workplace. Vistagen’s supportive workplace culture, mental health care benefits, emphasis on inclusion, and employee wellness programs have earned it MHA’s highest honor, the Platinum Bell Seal for Workplace Mental Health.

Vistagen (Nasdaq: VTGN), a neuroscience-focused biopharmaceutical company dedicated to pursuing a pioneering approach to the development of groundbreaking therapies for psychiatric and neurological disorders based on nose-to-brain neurocircuitry, today reported financial results for its fiscal year ended March 31, 2024, and provided a corporate update.

Vistagen (NASDAQVTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders, today announced it will host a conference call and webcast on Tuesday, June 11, 2024, at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to report results for its fiscal year 2024 ended March 31, 2024 and provide a corporate update.

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders, today announced that company management will present and host one-on-one meetings during the Jefferies Global Healthcare Conference taking place June 5 and 6, 2024 in New York City.

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders, today announced that it will present posters highlighting fasedienol, its investigational pherine candidate in Phase 3 development for the acute treatment of social anxiety disorder (SAD), and itruvone, its investigational pherine candidate in Phase 2 development for the treatment of major depressive disorder (MDD), at the American Society of Clinical Psychopharmacology Conference in Miami Beach, Florida from May 28 to 31, 2024.

Vistagen (Nasdaq: VTGN), a biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders, today announced that company management will present and host one-on-one meetings during the 2024 RBC Capital Markets Global Healthcare Conference taking place May 14 and 15, 2024 in New York City.

Vistagen (Nasdaq: VTGN), a biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders, today announced positive results from a Phase 2A pilot study of PH15, an investigational pherine nasal spray, for improvement of psychomotor impairment caused by mental fatigue. PH15 demonstrated a statistically significant improvement in reaction time compared to placebo and caffeine in sleep-deprived study participants.

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders, today announced that it will present posters detailing clinical trial data for fasedienol, an investigational pherine candidate in Phase 3 development for the acute treatment of social anxiety disorder (SAD), and PH80, a Phase 2 investigational pherine candidate for treatment of women’s health disorders, at the Anxiety and Depression Association of America (ADAA) Conference in Boston, Massachusetts from April 11 to 14, 2024.

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders, today announced that it has enrolled the first patient in its PALISADE-3 Phase 3 trial of fasedienol, an investigational pherine candidate in development for the acute treatment of social anxiety disorder (SAD).

Vistagen (Nasdaq: VTGN), a biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders, today announced that company management will present and host one-on-one meetings during the Stifel 2024 Virtual CNS Days taking place March 19 to 20, 2024.

Vistagen (Nasdaq: VTGN), a biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders, today announced that company management will present and host one-on-one meetings at the TD Cowen 44th Annual Health Care Conference in Boston, Massachusetts, March 4 to 6, 2024.

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver first-in-class therapies for psychiatric and neurological disorders, today reported financial results for its fiscal year 2024 third quarter ended December 31, 2023 and provided a corporate update.

Vistagen (NASDAQVTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver first-in-class therapies for psychiatric and neurological disorders, today announced it will host a conference call and webcast on Tuesday, February 13, 2024, at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to report results for its fiscal year 2024 third quarter ended December 31, 2023 and provide a corporate update.

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 that the European Patent Office (EPO) issued a Notice of Intention to Grant a patent related to the use of AV-101 for the treatment of neuropathic pain. AV-101 is the Company’s investigational oral prodrug of 7-chloro-kynurenic acid (7-Cl-KYNA), a potent and selective full antagonist (i.e., inhibitor) of the glycine coagonist site of the N-methyl-D-aspartate receptor (NMDAR). The patent, once granted, will not expire until at least 2034 and will become part of Vistagen’s global patent portfolio on therapeutic uses and manufacturing techniques for AV-101.

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 2024 second quarter ended September 30, 2023.

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 that company management will present and host one-on-one meetings at the Stifel 2023 Healthcare Conference taking place November 14 – 15, 2023 at the Lotte New York Palace Hotel in New York City.

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 Company will present at two upcoming scientific conferences in November.

Vistagen (NASDAQVTGN), 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 it will host a conference call and webcast on Thursday, November 9, 2023, at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to provide a corporate update and report results for its fiscal year 2024 second quarter ended September 30, 2023.

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 that the Company will present and host one-on-one meetings at the Jefferies Biotech CNS/Neuro Summit taking place October 11 – 12, 2023 in New York City, New York.

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 that PH80, one of the Company’s five investigational neuroactive nasal sprays, demonstrated statistically significant improvement versus placebo in an exploratory Phase 2A study for acute management of the symptoms of premenstrual dysphoric disorder (PMDD), including negative mood and physical and behavioral symptoms.

Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, and Fuji Pharma Co., Ltd. (“Fuji”) (TSE: 4554), a pharmaceutical company specializing in development, manufacture and marketing in the fields of women’s healthcare and acute medical care, today announced they have entered into a time-limited (up to approximately eighteen months) agreement to negotiate exclusively with each other regarding a potential license to develop and commercialize Vistagen’s PH80 in Japan, including for the acute treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause and potentially other indications. Vistagen’s PH80 neuroactive nasal spray demonstrated statistically significant efficacy versus placebo in an exploratory double-blind, placebo-controlled Phase 2A study in women diagnosed with menopausal hot flashes. Fuji will make a non-refundable payment of $1.5 million to secure the time-limited exclusive negotiation rights for the Japanese market.

Vistagen (NASDAQVTGN) 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 appointment of Cindy Anderson as Chief Financial Officer (CFO), effective August 21, 2023. Ms. Anderson will succeed Jerrold Dotson, whose planned retirement was announced in July of this year.

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 2024 first quarter ended June 30, 2023.

Vistagen (NASDAQVTGN), 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 it will host a conference call and webcast on Thursday, August 10, 2023, at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) to provide a corporate update and report results for its fiscal year 2024 first quarter ended June 30, 2023.

Vistagen (NASDAQVTGN), a 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 positive top-line results from its Phase 3 PALISADE-2 trial evaluating the efficacy, safety, and tolerability of fasedienol (PH94B) nasal spray in adults diagnosed with social anxiety disorder (SAD). 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.

Vistagen (NASDAQVTGN) 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 new mechanism of action data from a preclinical tissue distribution study in laboratory rats. The study demonstrated that a single intranasal administration of radiolabeled itruvone ([14C]PH10) was essentially undetectable in the brain and most other tissues, including blood and plasma.

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 that the Canadian Intellectual Property Office (CIPO) issued a Notice of Allowance for a patent related to the use of AV-101 for reduction of dyskinesia (sudden uncontrolled movements) induced by the administration of levodopa (L-Dopa), the most commonly prescribed medication for treatment of Parkinson's disease (PD). AV-101 is the Company’s oral prodrug antagonist at the NMDAR (N-methyl-D-aspartate receptor) glycine site. The patent, once granted, will not expire until at least 2034. The U.S. Patent and Trademark Office (USPTO) granted a related U.S. patent for Vistagen’s AV-101 and similar patents have been granted or are pending in several additional major pharmaceutical markets.

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.

Vistagen (NASDAQVTGN), 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 it will host a conference call and webcast on Wednesday, June 28, at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) to report results for its fiscal year 2023 ended March 31, 2023 and provide a corporate update.

Vistagen (NASDAQVTGN), 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 that, on June 22, 2023, Vistagen received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market, LLC (Nasdaq) indicating that Vistagen has regained full compliance with the minimum $1.00 bid price per share or greater requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market. Vistagen is now in full compliance with all applicable Nasdaq listing requirements, and Nasdaq considers the matter closed.

Vistagen (NASDAQVTGN) 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 favorable safety and tolerability data from its U.S. Phase 1 clinical trial of itruvone (PH10), the Company’s investigational rapid-onset pherine nasal spray for the treatment of major depressive disorder (MDD). Results from the U.S. Phase 1 study build on successful Phase 1 studies and a positive randomized, double-blind, placebo-controlled Phase 2A study of itruvone nasal spray in MDD previously conducted in Mexico and enable Phase 2B development of itruvone in the U.S. as an innovative stand-alone rapid-onset product candidate for treatment of MDD.

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 that its Chief Executive Officer, Shawn Singh, will participate in the Healthcare Virtual Conference presented by Maxim Group LLC taking place June 20 – 22, 2023 virtually on the M-Vest platform.

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 that the European Patent Office (EPO) issued an intention to grant a patent for the treatment of migraine by nasal administration of PH80 nasal spray, one of the Company’s five rapid-onset investigational neuroactive pherine therapeutics. The patent claims also include treatment administered at the onset of migraine symptoms and treatment of migraines associated with traumatic brain injury. The patent, once granted, will not expire until at least 2040. The U.S. Patent and Trademark Office (USPTO) recently granted a related U.S. patent for Vistagen’s PH80 nasal spray for treatment of migraine and similar patent applications are pending in several additional major pharmaceutical markets.

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 that PH80, one of the Company’s five investigational neuroactive nasal sprays, demonstrated statistically significant efficacy versus placebo in an exploratory Phase 2A study for the acute treatment of hot flashes (vasomotor symptoms) in women diagnosed with menopausal hot flashes.

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 that its Chief Executive Officer, Shawn Singh, will present and host one-on-one meetings at the Jefferies Global Healthcare Conference taking place June 7 – 9, 2023 in New York City, NY.

Vistagen (NASDAQVTGN) 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 that it will implement a stockholder-approved reverse stock split of its outstanding shares of common stock, at a ratio of one-for-thirty unanimously approved by its Board of Directors. Vistagen common stock will begin trading on a split-adjusted basis at the opening of trading on the Nasdaq Capital Market on Wednesday, June 7, 2023. The Company’s shares will continue to trade on the Nasdaq Capital Market under the symbol “VTGN,” with a new CUSIP number, 92840H400.

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 that positive safety and exploratory efficacy data from its large Phase 3 open-label study of fasedienol (PH94B) nasal spray for the treatment of anxiety in adults with social anxiety disorder (SAD) were presented in a late-breaking poster presentation at the American Society for Clinical Psychopharmacology (ASCP) 2023 Annual Meeting taking place in Miami from May 30 through June 2, 2023.

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 that safety and exploratory efficacy data from its Phase 3 open-label study of fasedienol (PH94B) nasal spray for the treatment of adults with social anxiety disorder (SAD) will be presented in a late-breaking poster presentation at the American Society for Clinical Psychopharmacology (ASCP) 2023 Annual Meeting taking place in Miami from May 30 through June 2, 2023.

Vistagen (NASDAQVTGN), 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 that it has been recognized by Mental Health America (MHA) for its commitment to fostering mental health and well-being in the workplace. Vistagen’s supportive workplace culture, mental health care benefits, focus on inclusion, and wellness programs have earned it MHA’s Platinum Bell Seal for Workplace Mental Health, MHA’s highest award for comprehensive workplace mental health support.

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 new data, presented at the 2023 Anxiety and Depression Association of America (ADAA) Conference in Washington, D.C., that further supporting the proposed mechanism of action (MOA) of fasedienol (PH94B), the Company’s rapid-onset investigational pherine nasal spray in Phase 3 development for the treatment of social anxiety disorder (SAD). Findings from the study demonstrate local metabolism and clearance of fasedienol from the nasal passages. This discovery of the local nasal clearance of fasedienol may explain prior research findings that fasedienol is absent from systemic circulation and from the brain after intranasal administration, contributing to its favorable safety profile in all clinical studies to date, which studies have involved over 30,000 doses of fasedienol administered to adults with SAD.

Vistagen (NASDAQVTGN) 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 that the European Patent Office (EPO) has granted the Company a patent for AV-101, its oral NMDAR (N-methyl-D-aspartate receptor) glycine site antagonist. The patent relates to the synthesis of AV-101 and certain chemical intermediaries, which synthesis yields AV-101 in commercial quantities and has the scalability for commercial manufacture. The new European patent is a counterpart to previously granted U.S. patent 11,427,530 and will be in effect until at least 2039. Based on observations and findings from preclinical animal models translatable to human conditions targeting the NMDAR, AV-101 has the potential to become a new oral treatment alternative for multiple CNS disorders involving the NMDAR, such as dyskinesia associated with levodopa therapy for Parkinson’s disease, major depressive disorder and neuropathic pain.

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 positive feedback from its recent engagement with the U.S. Food and Drug Administration (FDA) regarding the use of the Liebowitz Social Anxiety Scale (LSAS) as the primary endpoint for future clinical studies designed to evaluate the efficacy of a treatment for the overall control of symptoms of social anxiety disorder (SAD). With FDA feedback confirming the acceptable use of the LSAS as a primary efficacy endpoint, Vistagen is positioned to finalize key components of its potential New Drug Application (NDA)-enabling development program for fasedienol for treatment of SAD. Dr. Michael R. Liebowitz, a Columbia University psychiatrist, former director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute and current Managing Director of The Medical Research Network LLC in New York City, is the innovator of the LSAS and is the Principal Investigator in Vistagen’s new FEARLESS program, the Company’s Phase 3 development program for fasedienol for treatment of SAD.

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 positive data from its Phase 3 open-label study designed to evaluate the safety and tolerability of multiple, as-needed intranasal administrations of fasedienol (PH94B) over time in adults with social anxiety disorder (SAD). For the primary endpoint of safety and tolerability (safety population: n=481), the long-term administration of 3.2 µg of fasedienol, up to four times a day, as-needed, was safe and well-tolerated, with no new safety findings or trends identified, regardless of the number of doses administered by each subject. 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. Analysis of the final data set demonstrates clinically meaningful functional improvement, as measured by the LSAS, and total LSAS scores continued to decline in consecutive months during the study.

Vistagen (NASDAQVTGN) 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 that the last participant has completed the study protocol in its U.S. Phase 1 clinical trial of itruvone (PH10), the Company’s investigational pherine nasal spray for the treatment of major depressive disorder (MDD).

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 that its Chief Executive Officer, Shawn Singh, will present and host one-on-one meetings at the Cowen 43rd Annual Health Care Conference taking place March 6 – 8, 2023 in Boston, MA.

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 that the U.S. Patent and Trademark Office (USPTO) has granted a U.S. patent for Vistagen’s PH80 nasal spray for treatment of migraine. The newly issued patent will be in effect until at least 2040.

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 third quarter ended December 31, 2022.

Vistagen (NASDAQVTGN), 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 it will host a conference call and webcast on Tuesday, February 7, 2023, at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to report financial results for its fiscal year 2023 third quarter ended December 31, 2022 and provide a corporate update.

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 now owns all 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), as well as three additional drug candidates in earlier stages of development: PH15 for cognition improvement; PH80 for migraine and hot flashes; and PH284 for appetite-related disorders. Vistagen’s acquisition of Pherin eliminates all future royalty payment obligations related to its five pherine nasal spray drug candidates.

Vistagen (NASDAQVTGN) 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 first cohort of healthy volunteers has been dosed in its U.S. Phase 1 clinical trial of PH10, the Company’s investigational pherine nasal spray in development for the treatment of major depressive disorder (MDD).

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 that the last patient has completed the study protocol in its Phase 2 clinical trial of PH94B for the treatment of adults experiencing adjustment disorder with anxiety (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 announced that the Company has taken important strategic steps to secure additional patent protection for its lead product candidate, PH94B, through the recent filing of national applications at the U.S. Patent and Trademark Office (USPTO) and counterpart patent authorities in major pharmaceutical markets outside the U.S. for the treatment of adjustment disorder (AjD).

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.

Vistagen (NASDAQVTGN) 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 U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of PH10, one of the Company’s investigational nasal sprays, for the treatment of major depressive disorder (MDD). The FDA’s Fast Track program facilitates the expedited development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs, with the intention to bring promising new medicines to patients sooner.

Vistagen, (NASDAQVTGN) 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 receipt of a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA). The letter greenlights a U.S. Phase 1 clinical trial under Vistagen’s newly filed Investigational New Drug (IND) application for clinical development of PH10 in the U.S. as a standalone treatment for major depressive disorder (MDD). The small Phase 1 trial (n=12) will involve the Company’s newly optimized formulation of PH10 and is intended to both confirm the favorable safety profile of PH10 established in three previous clinical studies conducted in Mexico, including a published Phase 2A study for the treatment of MDD, and facilitate Vistagen’s plans for Phase 2B development of PH10 as a stand-alone treatment for MDD.

Vistagen (NASDAQVTGN) 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 publication of positive results from a preclinical study of the effects of AV-101, its oral NMDA receptor glycine site antagonist, in a widely used MPTP non-human primate model for reproducing motor complications of Parkinson's disease (PD), including dyskinesia (sudden uncontrolled movements) observed in PD patients treated with levodopa (L-Dopa). Findings from the preclinical study were published in the international, peer-reviewed journal, Cells. In the preclinical study, AV-101 reduced L-Dopa-induced dyskinesias (LID) by about 25% while maintaining the antiparkinsonian response to L-Dopa.

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.

Vistagen (NASDAQVTGN), 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 it will host a conference call and webcast on Thursday, November 10, 2022, at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to report financial results for its fiscal year 2023 second quarter ended September 30, 2022.

Vistagen Therapeutics, Inc. (Nasdaq: VTGN) (Vistagen, the Company), 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 that its Chief Executive Officer, Shawn Singh, will present and host one-on-one meetings at the Stifel 2022 Healthcare Conference taking place in New York on November 15 and 16, 2022.

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 that the company’s Chief Executive Officer, Shawn Singh, will lead a Concordia Live Webinar on the need for innovative approaches to mental health treatment. This virtual roundtable session will explore how Americans can work together to break down mental health stigmas, as well as the logistics of implementing a new standard of care felt horizontally across a diverse, equitable society.

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 that its Chief Executive Officer, Shawn Singh, will participate in a panel discussion regarding emerging therapies for psychiatric disorders and host one-on-one meetings at the Cantor Neurology & Psychiatry Conference taking place in San Francisco on October 6 and 7, 2022.

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 that its Chief Executive Officer, Shawn Singh, will participate in a private executive roundtable on September 20th at the 2022 Concordia Annual Summit being held September 19-21, 2022, in New York City.