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Vistagen PALISADE-4 Phase 3 Trial of Fasedienol Misses Primary Endpoint; Post-Hoc Signal in Severe Subgroup
PALISADE-4 trial (n=238) did not meet primary endpoint: LS mean change SUDS fasedienol -9.5 vs placebo -11.4 (p=0.427).
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Two Vistagen directors will not stand for re-election at 2026 Annual Meeting
Margaret FitzPatrick (June 16) and Joanne Curley (June 17) notified Vistagen they will not stand for re-election.
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Vistagen FY2026 net loss $69.7M; PALISADE-4 topline results expected June 2026
Net loss of $69.7M for FY ended March 31, 2026, vs $51.4M prior year; R&D expense $55.0M.
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Vistagen achieves ICH E1 safety exposure minimum for fasedienol; over 1,500 subjects dosed
As of May 31, 2026: over 1,500 subjects with ≥1 dose, 300 with ≥6 months, 100 with ≥12 months exposure to fasedienol.
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Vistagen appoints Angel S. Angelov, MD, MBA, as Chief Medical Officer effective May 18, 2026
Dr. Angelov brings two decades of industry experience including roles at Karuna Therapeutics, Neurocrine Biosciences, Novartis, and Teva.
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Vistagen reports positive preliminary OLE data for fasedienol in SAD; well-tolerated up to 12 months
OLE safety (n=341): discontinuation due to AEs 2.6%; no SAEs related to fasedienol; TEAEs >5%: headache 10.9%, URI 11.4%.
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Vistagen completes PALISADE-4 Phase 3 patient visits; topline data due Q2 2026
Last patient completed randomized portion of Phase 3 trial for fasedienol acute treatment of social anxiety disorder.
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Vistagen gets FDA 'Study May Proceed' letter for refisolone nasal spray in menopausal hot flashes
FDA allows Vistagen to pursue further Phase 2 clinical development of refisolone in U.S. for vasomotor symptoms due to menopause.
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Vistagen grants 75,000-share options to CEO, CFO, and three other executives at $0.5358
Options granted to five executives: CEO Shawn Singh, CLO Reid Adler, CDO Elissa Cote, COO Joshua Prince, CFO Nick Tressler.
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Vistagen falls below Nasdaq audit committee minimum after director resignation
Ms. Mary Rotunno resigned from the Board effective April 1, 2026, reducing Audit Committee from 3 to 2 members.
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Mary Rotunno resigns from Vistagen Therapeutics board effective April 1, 2026
Mary Rotunno resigned from the Board of Directors on March 17, 2026, effective April 1, 2026.
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Vistagen files new corporate presentation; no material updates disclosed
Filed 8-K to announce use of updated corporate presentation dated March 2026.
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Vistagen cuts workforce 20%, cites cash management; PALISADE-4 results expected H1 2026
Reduced workforce by approximately 20% to prioritize fasedienol PALISADE-4 Phase 3 trial.
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Vistagen Therapeutics director Paul Edick resigns; board vacancy to be filled
Paul Edick resigned from the Board of Directors effective February 13, 2026.
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Vistagen Q3 FY2026 net loss $18.9M; PALISADE-4 topline expected H1 2026
Net loss $18.9M for quarter ended Dec 31, 2025, vs $14.1M a year ago; R&D expense $14.2M, G&A $5.6M.
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Vistagen receives Nasdaq deficiency notice for minimum bid price non-compliance
Received Nasdaq notice on Feb 3, 2026 for non-compliance with $1.00 minimum bid price requirement.
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Vistagen releases corporate presentation highlighting nose-to-brain neuroscience platform
Presentation dated January 2026 describes nose-to-brain neurocircuitry for CNS disorders.
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Vistagen's PALISADE-3 Phase 3 study of fasedienol fails primary endpoint in social anxiety disorder
LS mean change from baseline on SUDS score: fasedienol 13.6 (SE 1.54) vs placebo 14.0 (SE 1.51); no statistical significance.
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Vistagen appoints Nick Tressler as CFO effective Dec 1, 2025
Nick Tressler named CFO & Treasurer, effective Dec 1, 2025; succeeds Shawn Singh as interim PFO.
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Vistagen reports Q2 FY2026 net loss $19.4M; PALISADE-3 Phase 3 complete, topline due Q4 2025
Net loss $19.4M vs $13.0M YoY; R&D expense $15.9M (up 56% YoY) on PALISADE program.
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Vistagen completes PALISADE-3 Phase 3 trial; topline results due by year end
Last patient completed randomized, double-blind, placebo-controlled portion of PALISADE-3 for fasedienol in social anxiety disorder; open-label extension ongoing.
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Vistagen appoints Paul Edick to Board of Directors, effective October 27, 2025
Mr. Edick appointed to Board, Audit Committee, and Compensation Committee.
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Vistagen CFO Cynthia Anderson resigns effective Oct 15; annual meeting votes ratified
CFO Cynthia L. Anderson resigns effective Oct 15, 2025; resignation not due to any disagreement with company.
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Vistagen reports Q1 net loss of $15.1M; fasedienol Phase 3 data expected Q4 2025 and H1 2026
Net loss $15.1M for fiscal Q1 ended June 30, 2025, vs $10.7M a year ago; R&D expense up to $11.7M.
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Vistagen appoints Elissa Cote as Chief Corporate Development Officer
Cote appointed CCDO effective June 23, 2025, to lead strategic partnerships and pherine platform advancement.
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Vistagen reports FY2025 net loss $51.4M; cash $80.5M; advances PALISADE fasedienol trials
FY2025 net loss $51.4M (vs $29.4M prior year); R&D expenses doubled to $39.4M on fasedienol and PH80 programs.
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Vistagen updates fasedienol Phase 3 timelines: PALISADE-3 data Q4 2025, PALISADE-4 H1 2026
PALISADE-3 topline data remains on track for Q4 2025; PALISADE-4 now expected in H1 2026.
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Vistagen sued by pro se plaintiffs over alleged misleading clinical trial disclosures
John Cesario and David Preka filed lawsuit on Feb 13, 2025 (Case No. 4:25-cv-01510) in Northern District of California.
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Vistagen reports Q3 FY2025 net loss $14.1M; fasedienol Phase 3 progressing
Net loss $14.1M for Q3 ended Dec 31, 2024, vs $6.4M YoY; R&D expense rose to $11.3M from $4.5M.
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Vistagen receives US patent for AV-101 to treat neuropathic pain; patent exp. 2034
USPTO granted patent for oral non-opioid AV-101 covering neuropathic pain, expiring at least 2034.
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Vistagen announces positive Phase 2A results for PH284 in cancer cachexia; 71% hunger improvement
PH284 nasal spray demonstrated 71% improvement in subjective feeling of hunger before dinner on Day 7 vs <1% for placebo.
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Vistagen enrolls first subject in fasedienol repeat dose study for social anxiety disorder
Phase 2 exploratory trial evaluating repeat dose of fasedienol (3.2 mcg) in adults with SAD during a public speaking challenge.
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Vistagen posts new corporate presentation; no specific financial updates
Company released an updated corporate presentation on December 6, 2024.
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Vistagen Q2 FY2025 net loss $13.0M; Phase 3 SAD trials on track for 2025 data
Net loss of $13.0M for Q2 ended Sep 30, 2024 vs $6.6M a year ago, driven by higher R&D costs.
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Vistagen enrolls first subject in PALISADE-4 Phase 3 trial of fasedienol for SAD
First subject enrolled in PALISADE-4 Phase 3 trial of fasedienol nasal spray for acute treatment of social anxiety disorder (SAD).
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Vistagen stockholders elect all seven director nominees, approve say-on-pay, ratify auditors at 2024 annual meeting
All seven director nominees elected, including CEO Shawn K. Singh with 14,540,841 votes for and 154,427 withheld.
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Vistagen Q1 FY2025 net loss $10.7M; PALISADE Phase 3 trials on track for 2025 results
Net loss of $10.7M for Q1 FY2025, up from $6.9M in Q1 FY2024.
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Vistagen dismisses WithumSmith+Brown, appoints KPMG as new auditor
Dismissed WithumSmith+Brown, PC as auditor effective July 8, 2024, after competitive selection process by Audit Committee.
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Vistagen expands PH80 global patent portfolio with new migraine treatment patents in four countries
New patents for PH80 migraine treatment issued/allowed in Australia, Hong Kong, Japan, and Mexico.
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Vistagen awarded MHA Platinum Bell Seal for Workplace Mental Health for 2nd year
Received Mental Health America's highest honor, Platinum Bell Seal, for second consecutive year.
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Vistagen FY2024 net loss narrows to $29.4M; fasedienol Phase 3 program on track
Net loss of $29.4M for FY2024, down from $59.2M in FY2023; cash and equivalents $119.2M as of March 31, 2024.
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Vistagen stockholders approve major increase in authorized equity shares
Approved amendment to 2019 Omnibus Equity Incentive Plan: authorized shares increase from 1M to 5M; 82.0% votes cast in favor.
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Vistagen to present fasedienol and itruvone data at ASCP conference May 28-31
Poster on fasedienol (Phase 3 for social anxiety disorder) from PALISADE-2 trial on May 29.
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Vistagen announces positive Phase 2A results for PH15 nasal spray improving psychomotor impairment from mental fatigue
PH15 nasal spray demonstrated statistically significant improvement in reaction time versus placebo and caffeine (p<0.001) in sleep-deprived participants.
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Vistagen enrolls first patient in PALISADE-3 Phase 3 fasedienol trial for social anxiety disorder
PALISADE-3 is a randomized, double-blind, placebo-controlled study of ~236 adults aged 18–65 with SAD.
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Vistagen reports narrower net loss of $6.3M in fiscal Q3; fasedienol trials on track
Net loss $6.3M vs $9.8M YoY; cash $126.6M at Dec 31, 2023.
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Vistagen begins using updated corporate presentation on January 8, 2024
New corporate presentation adopted by Vistagen Therapeutics on Jan 8, 2024.
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Vistagen receives EPO notice of intention to grant AV-101 patent for neuropathic pain
European Patent Office issued Notice of Intention to Grant patent for AV-101 to treat neuropathic pain.
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Vistagen reports Q2 net loss $6.6M; fasedienol PALISADE-2 positive; cash $37.6M + $93.5M offering
Net loss $6.6M for Q2 end Sep 30, 2023 vs $17.5M YoY; R&D expense decreased to $3.9M.
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Vistagen receives $1.5M from Fuji Pharma for exclusive PH80 negotiation in Japan
Received $1.5M non-refundable payment from Fuji Pharma for exclusive negotiation rights to license PH80 in Japan.