Vistagen Therapeutics, Inc. - VTGN STOCK NEWS

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.

Vistagen (Nasdaq: VTGN) has completed its acquisition of Pherin Pharmaceuticals, securing full ownership of PH94B and PH10, eliminating future royalty payments. The company is advancing its PH94B Phase 3 program for social anxiety disorder and has initiated a Phase 1 study for PH10 in major depressive disorder, which received FDA Fast Track designation. Research and development expenses decreased from $7.8 million to $6.9 million year-over-year, while net losses narrowed from $10.7 million to $9.8 million. Vistagen aims to explore multiple administration strategies for PH94B and anticipates announcing further developments in 2023.

Vistagen (NASDAQ: VTGN) announced a conference call scheduled for February 7, 2023, at 2:00 p.m. PT to discuss its fiscal year 2023 third quarter financial results, ending December 31, 2022. The call will provide updates on the company's efforts to transform treatment for CNS disorders, focusing on anxiety and depression. Vistagen is developing pherines, a new class of therapeutics aimed at faster relief with fewer side effects. The company emphasizes its commitment to improving mental health care with innovative treatment options.

Vistagen (Nasdaq: VTGN) has successfully acquired Pherin Pharmaceuticals, eliminating all future royalty obligations for its leading drug candidates, PH94B and PH10. PH94B is in Phase 3 for social anxiety disorder, while PH10 is in clinical development for major depressive disorder. This acquisition not only enhances Vistagen's portfolio, including three additional drug candidates, but also significantly improves the commercial outlook for these products. CEO Shawn Singh emphasized the strategic importance of this acquisition in advancing treatments for anxiety and depression, which affect millions.

Vistagen (NASDAQ: VTGN) has initiated a Phase 1 clinical trial for PH10, a pherine nasal spray targeting major depressive disorder (MDD). The trial's primary aim is to evaluate the safety and tolerability of PH10 in 12 healthy adult subjects, building on previous favorable results from three earlier studies, including a Phase 2A trial in Mexico. The study, expected to conclude by Q1 2023, is a stepping stone towards the company's Phase 2B development plans. PH10’s unique mechanism activates chemosensory neurons to produce rapid antidepressant effects without systemic uptake, potentially differentiating it from existing treatments.