Vistagen Therapeutics, Inc. - VTGN STOCK NEWS

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.

Vistagen (Nasdaq: VTGN) announces the completion of the Phase 2 clinical trial for PH94B, aimed at treating adults with adjustment disorder with anxiety. This exploratory study was a U.S.-based, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of PH94B over four weeks. The primary endpoint focused on anxiety level reduction, gauged via the Hamilton Anxiety Rating Scale. Topline results are expected by the end of Q1 2023, marking a significant milestone amid growing mental health challenges.

Vistagen (Nasdaq: VTGN) recently announced new patent filings with the U.S. Patent and Trademark Office and other countries to enhance commercial protection for its lead drug candidate, PH94B, aimed at treating adjustment disorder (AjD). This move follows a similar patent protection obtained for PH94B regarding social anxiety disorder (SAD) and PH10 for major depressive disorder (MDD). Additionally, the pending acquisition of Pherin Pharmaceuticals will expand Vistagen's patent portfolio and pipeline, including new drug candidates targeting various mental health disorders.

Vistagen (Nasdaq: VTGN) has announced a definitive agreement to acquire Pherin Pharmaceuticals, acquiring its pherine pipeline for approximately 12.4 million shares of common stock and a nominal cash amount. This acquisition will eliminate future royalty and milestone payments related to Vistagen’s existing drug candidates, PH94B and PH10, while adding three new drug candidates. The acquisition is expected to strengthen Vistagen’s position in addressing treatment gaps for anxiety and depression. The deal is subject to customary closing conditions and Pherin stockholder approval.

Vistagen (NASDAQ: VTGN) has received Fast Track designation from the FDA for its investigational nasal spray, PH10, aimed at treating major depressive disorder (MDD). This designation is intended to expedite development for drugs addressing serious conditions. PH10 has shown promising results in clinical studies, significantly reducing depressive symptoms within one week of treatment while avoiding common psychological side effects. With 21 million adults in the U.S. experiencing MDD annually, Vistagen aims to meet an urgent treatment need.

Vistagen (NASDAQ: VTGN) has received FDA approval to proceed with a small Phase 1 clinical trial for its investigational treatment, PH10, aimed at major depressive disorder (MDD). This trial will confirm the favorable safety profile observed in previous studies and help advance to Phase 2B development. The Phase 1 study, involving 12 participants, is scheduled for Q1 2023. PH10 demonstrated significant reduction in depressive symptoms in earlier studies without causing adverse psychological effects. The company aims to provide new therapies for those in urgent need.

Vistagen (NASDAQ: VTGN) reported positive results from a preclinical study on AV-101, an oral NMDA receptor antagonist, in a MPTP non-human primate model for Parkinson's disease. The study demonstrated a significant 25% reduction in levodopa-induced dyskinesia (LID) while maintaining levodopa's antiparkinsonian effects. Conducted by Dr. Thérèse Di Paolo, the research highlights AV-101's potential to enhance treatment for motor complications in Parkinson's. Additionally, the U.S. Patent and Trademark Office issued Patent No. 10,632,091 for AV-101's therapeutic use, valid until at least 2034.

Vistagen (VTGN) reported significant progress in its clinical trials for PH94B and PH10 aimed at treating social anxiety disorder and major depressive disorder. After an independent interim analysis recommended continuing the PALISADE-2 Phase 3 study, Vistagen is preparing to restart it and meet with the FDA. The PALISADE Open Label Study showed strong improvements in anxiety symptoms for nearly 400 participants. Financially, R&D expenses rose to $12.9 million in Q2 FY2023, with a net loss of approximately $17.5 million, while cash reserves stood at about $35.3 million as of September 30, 2022.

Vistagen (NASDAQ: VTGN), a late clinical-stage biopharmaceutical company focused on CNS disorders, will host a conference call on November 10, 2022, at 2:00 p.m. PT to discuss its fiscal Q2 2023 financial results, which ended on September 30, 2022. The firm is developing therapeutics aimed at treating anxiety and depression with fewer side effects than current options. Key candidates include PH94B and PH10, designed as rapid-onset neuroactive steroids that target olfactory pathways. The event will also feature a webcast and telephonic replay after the call.