Vistagen Therapeutics, Inc. develops late clinical-stage biopharmaceutical programs based on nose-to-brain neurocircuitry and intranasal pherine product candidates. Company news centers on fasedienol nasal spray for the acute treatment of social anxiety disorder, including PALISADE Phase 3 study updates, and refisolone nasal spray for vasomotor symptoms due to menopause.
Recurring updates also cover FDA and IND communications, clinical data from psychiatric and neurological programs, fiscal results, cash-management actions, executive and board changes, and healthcare investor conference presentations. The company’s pipeline is described around investigational intranasal candidates for indications that include social anxiety disorder, major depressive disorder, and menopausal hot flashes.
VistaGen Therapeutics (NASDAQ: VTGN) has appointed Louis Monti, M.D., Ph.D., as Vice President of Translational Medicine, expanding its R&D team. Dr. Monti has worked with the company since 2018 on drug candidates PH94B and PH10, designed to treat anxiety and depression. PH94B has received FDA Fast Track designation and is preparing for Phase 3 trials for social anxiety disorder (SAD). PH10 is set for Phase 2B development for major depressive disorder (MDD). Both candidates show potential as rapid-onset treatments, which could revolutionize the management of these mental health disorders.
VistaGen Therapeutics (NASDAQ: VTGN) reported its fiscal 2021 Q2 financial results for the quarter ending September 30, 2020. The company demonstrated a reduced net loss of approximately $3.7 million, down from $5.7 million in the prior year. Revenue for the quarter was $334,000 associated with a $5 million upfront license payment from EverInsight Therapeutics. R&D expenses decreased significantly to $2.4 million, reflecting the completion of previous clinical studies. VistaGen is advancing its CNS pipeline, preparing for a pivotal Phase 3 study of PH94B for social anxiety disorder set to launch in Q2 2021.
VistaGen Therapeutics (NASDAQ: VTGN) announced new in vitro data showing that PH94B, an intranasal treatment for social anxiety disorder, does not activate GABA-A receptors, differentiating it from benzodiazepines. This suggests that PH94B may avoid common side effects, such as sedation and addiction, making it a safer alternative for treating anxiety. With the FDA's Fast Track designation for PH94B, the company aims to address rising anxiety disorders exacerbated by current societal stressors, moving towards pivotal Phase 3 development.
VistaGen Therapeutics (NASDAQ: VTGN) announced participation in the Guggenheim Healthcare Talks, specifically at the 2nd Annual Neuro/Immunology Day on November 16, 2020. This virtual event will focus on neurological and immunological diseases, highlighting both established and emerging companies. VistaGen is dedicated to developing innovative treatments for anxiety, depression, and other CNS disorders, and is committed to exceeding current treatment standards. For more details, visit www.vistagen.com.
VistaGen Therapeutics (NASDAQ: VTGN) has received a 180-day extension from Nasdaq to regain compliance with its minimum bid price requirement, now having until April 12, 2021. This extension does not impact the company's current listing status on the Nasdaq Capital Market. CEO Shawn K. Singh expressed optimism about regaining compliance while advancing their three CNS drug candidates aimed at addressing anxiety and depression disorders.
VistaGen Therapeutics (VTGN) announced promising data from its second preclinical study of AV-101 combined with probenecid, which may enhance the treatment of central nervous system (CNS) disorders. The study showed that the combination significantly raised brain levels of AV-101's active metabolite, 7-Cl-KYN, improving its therapeutic potential. AV-101, with an excellent safety profile and no significant side effects, could offer a new treatment option for anxiety and depression. The findings could lead to further clinical development under FDA's Fast Track designation for both major depressive disorder and neuropathic pain.
VistaGen Therapeutics (Nasdaq: VTGN), a biopharmaceutical firm focused on CNS disorders, will present at the LD Micro 500 Virtual Conference from September 1-4, 2020. CEO Shawn Singh will speak on September 3 at 11 a.m. EDT. Investors can watch the live webcast by registering online. VistaGen's pipeline includes three drug candidates targeting anxiety and depression, all showing promising safety profiles. The presentation aims to highlight the company's innovative approach to treating CNS disorders and its position within the micro-cap market.
VistaGen Therapeutics (Nasdaq: VTGN) reported its fiscal 2021 Q1 results, highlighting key advancements in its drug development pipeline. The Company reached an agreement with the FDA on PH94B's Phase 3 study for social anxiety disorder, with enrollment for 182 adults planned. Financially, VistaGen secured a $5 million non-dilutive license payment and completed a public offering, raising approximately $14.29 million. Notably, net loss decreased to $3.5 million, while R&D expenses dropped from $4.3 million to $1.7 million compared to the previous year.
VistaGen Therapeutics (Nasdaq: VTGN) announced that underwriters of its public offering exercised their over-allotment option, bringing additional gross proceeds of approximately $1.79 million. Overall, the offering totaled $14.29 million with 17,868,250 shares issued. The funds will support the development of CNS pipeline programs, general research, and working capital. Maxim Group LLC managed the offering, which was conducted under an effective shelf registration statement with the SEC.
VistaGen Therapeutics, Inc. (Nasdaq: VTGN) has closed an underwritten public offering of 15,625,000 shares at $0.80 per share, generating $12.5 million in gross proceeds. The proceeds will support the development of CNS pipeline programs, R&D, and general corporate purposes. An option for underwriters to purchase up to an additional 2,343,750 shares within 45 days is also granted. The offering was conducted under an effective shelf registration statement.