VistaGen Therapeutics (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, is reporting its financial results and corporate highlights for fiscal year 2023, the period ended Sept. 30, 2022. Among the highlights include news that an independent analysis of VTGN’s PALISADE-2 phase 3 study evaluating social anxiety disorder (“SAD”) recommends continuing the study and that analysis of nearly 400 subjects in the final data set for a second study, the PALISADE open label study, showed participants exhibiting robust functional improvement in anxiety-provoking social and performance situations; the report also noted that VistaGen anticipates meeting with the U.S. Food and Drug Administration to discuss the next step in phase 3 development of its PH94B in the treatment of SAD. Financial numbers of note include an increase in R&D of $2.9 million, up from $10 million for the same quarter in 2021 to $12.9 million for the quarter ended 2023; general and administrative expense also increased, reaching approximately $3.7 million for the quarter with net loss attributable to common stockholders for the fiscal quarters ended Sept. 30, 2022 and 2021, being approximately $17.5 million and $13.2 million, respectively.
“During the past quarter, VistaBen achieved several important milestones to advance our CNS pipeline,” said VistaGen Therapeutics CEO Shawn Singh in the press release. “Recent independent data analysis supports our work to restart our PALISADE-2 phase 3 study of PH94B in social anxiety disorder, and preliminary data from nearly 400 subjects in our PALISADE open label study demonstrate that PH94B has potential to help millions of individuals suffering from social anxiety disorder, without the side effects and safety concerns often associated with prior FDA approvals in SAD and other off-label treatment options. We are focused on optimizing clinical studies for PH94B, and we will soon meet with the FDA to pursue a consensus path forward in our Phase 3 program in social anxiety disorder. We are also advancing our second pherine asset, PH10. We recently submitted our U.S. Investigational New Drug application for a small phase 1 study to facilitate entering phase 2B development of PH10 in major depressive disorder. Both therapies have the potential to offer novel, fast-acting treatment for millions of patients confronting the effects of debilitating mental health challenges.”
To view the full press release, visit https://ibn.fm/KXTE0
About VistaGen Therapeutics Inc.
VistaGen is a late clinical-stage CNS-focused biopharmaceutical aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders. The company is advancing therapeutics with the potential to be faster acting and with fewer side effects and safety concerns than those that are currently available. Vistagen’s clinical-stage candidates are targeting multiple forms of anxiety and depression. Candidates include PH94B and PH10, which belong to a new class of drugs known as pherines, which are investigational neuroactive steroids designed with a novel rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can impact the olfactory-amygdala neural circuits without systemic uptake or direct activity on CNS neurons in the brain. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety and depression — one mind at a time. For more information about the company, please visit www.VistaGen.com.
NOTE TO INVESTORS: The latest news and updates relating to VTGN are available in the company’s newsroom at https://ibn.fm/VTGN
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