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 (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.
Vistagen Therapeutics (Nasdaq: VTGN), a clinical-stage biopharmaceutical company focused on CNS disorders, announced that CEO Shawn Singh will present at the Stifel 2022 Healthcare Conference in New York on November 15, 2022, at 9:10 a.m. Eastern Time. The company is developing innovative therapeutics for anxiety and depression, including investigational drugs PH94B and PH10, which offer a novel rapid-onset mechanism. Investors can arrange one-on-one meetings by contacting the conference coordinator.
Vistagen Therapeutics (Nasdaq: VTGN) announced the adjournment of its 2022 Annual Meeting to October 28, 2022 to vote on two critical proposals: a reverse stock split to maintain its Nasdaq listing and an amendment to its bylaws regarding board composition. Currently, approximately 45.5% of shares voted support for the reverse split, while only 28.9% back the bylaw amendment. The company encourages stockholders to review the proxy statement filed with the SEC on August 31, 2022 for more details.