Vistagen Therapeutics Inc Stock Price, News & Analysis

Vistagen (Nasdaq: VTGN) announced new findings at the 2023 Anxiety and Depression Association of America (ADAA) Conference in Washington, D.C., supporting the mechanism of action of fasedienol (PH94B), a nasal spray in Phase 3 development for social anxiety disorder (SAD). The study revealed that fasedienol is metabolized locally in the nasal passages, not requiring systemic uptake, thereby enhancing its safety profile. Over 30,000 doses have been administered without adverse effects. This first-in-class therapy acts on nasal receptors to activate amygdala circuits, presenting a novel treatment approach compared to traditional therapies which often have delayed onset and significant side effects. These developments position Vistagen favorably within the biopharmaceutical landscape, focusing on innovative solutions for anxiety and depression.

Vistagen (NASDAQ: VTGN) announced the European Patent Office granted a patent for AV-101, an oral NMDAR glycine site antagonist aimed at treating CNS disorders. This patent supports the synthesis of AV-101 in commercial quantities and mirrors a U.S. patent effective until at least 2039. The company views AV-101 as a potential treatment for conditions like Parkinson's dyskinesia, major depressive disorder, and neuropathic pain. CEO Shawn Singh emphasized the importance of expanding the patent portfolio for future development and commercialization strategies. AV-101 shows promising preclinical results and is well-tolerated in clinical studies, leading to its Fast Track designation by the FDA for major depressive disorder and neuropathic pain. Vistagen aims to revolutionize treatment for anxiety and depression while avoiding significant side effects associated with current therapies.

Vistagen (Nasdaq: VTGN) has received positive feedback from the FDA regarding the use of the Liebowitz Social Anxiety Scale (LSAS) as the primary efficacy endpoint for its Phase 3 clinical trial of fasedienol, an investigational treatment for social anxiety disorder (SAD). This guidance positions Vistagen to finalize its New Drug Application (NDA)-enabling development plan. Current data suggest fasedienol could significantly improve symptoms of SAD, already demonstrated in earlier Phase 2 trials. The FDA also supported further studies on fasedienol's dosing strategy, crucial for future trials, including the upcoming FEARLESS-1 study.

Vistagen (Nasdaq: VTGN) announced positive results from its Phase 3 open-label study of fasedienol (PH94B) for social anxiety disorder (SAD). Involving nearly 500 patients, the long-term intranasal administration was deemed safe and well-tolerated, with no new safety findings. The study showed significant reductions in anxiety and avoidance behaviors as measured by the Liebowitz Social Anxiety Scale (LSAS). Notably, 55% of patients experienced a 20-point or greater reduction after three months. These outcomes suggest that fasedienol may provide a unique, rapid-onset treatment option for individuals with SAD.

Vistagen (NASDAQ: VTGN) announced the completion of participant enrollment in a Phase 1 clinical trial for itrivone (PH10), an investigational nasal spray aimed at treating major depressive disorder (MDD). This randomized, double-blind, placebo-controlled study focuses on confirming the safety and tolerability of itruvone in healthy adults, building on previous studies that demonstrated its favorable safety profile. Topline results are expected in Q2 2023, with plans to advance to Phase 2B development based on the outcomes. Itruvone utilizes a unique mechanism of action distinct from current depression treatments, potentially offering rapid onset effects without common side effects.

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company, announced its CEO, Shawn Singh, will present at the Cowen 43rd Annual Health Care Conference from March 6-8, 2023, in Boston, MA. Singh's presentation is on March 8, 2023, at 12:50 p.m. Eastern Time at the Boston Marriott Copley Place. This conference will feature presentations and discussions on various healthcare topics. Vistagen focuses on developing innovative treatments for anxiety, depression, and other CNS disorders, with a commitment to faster-acting therapies that reduce side effects. More information can be found at www.Vistagen.com.

Vistagen (Nasdaq: VTGN) has announced the granting of a new U.S. patent for its PH80 nasal spray, designed for migraine treatment, with protection extending until at least 2040. This investigational product offers a rapid-onset mechanism of action, distinguishing it from current CNS treatments. Migraine affects around 40 million U.S. adults annually, highlighting a significant need for effective therapies. Vistagen's recent acquisition of Pherin Pharmaceuticals grants it complete ownership of intellectual property rights for five pherine candidates, including PH80. The company aims to innovate CNS disorder treatments.