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Vistagen Therapeutics, Inc. filings document regulatory and corporate events for a Nasdaq-listed late clinical-stage biopharmaceutical company. Recent Form 8-K disclosures cover clinical program updates for fasedienol in the PALISADE social anxiety disorder program, FDA-related developments for refisolone under an IND application, and Regulation FD materials such as corporate presentations.
The company’s filings also record governance and capital-structure matters, including board departures, Audit Committee composition and Nasdaq listing-rule compliance, employee retention awards under the Amended and Restated 2019 Omnibus Equity Incentive Plan, and workforce and cash-management actions tied to clinical-development priorities.
Vistagen Therapeutics (VTGN) is a late clinical-stage neuroscience company developing intranasal “pherine” medicines targeting social anxiety disorder (SAD), major depressive disorder (MDD), menopausal hot flashes, psychomotor impairment from mental fatigue, and cancer cachexia. Its lead candidate, fasedienol, is in a U.S. Phase 3 SAD program with mixed results: PALISADE‑2 met its primary endpoint, while PALISADE‑1 and PALISADE‑3 did not. Topline data from PALISADE‑4 and a repeat‑dose study are expected in 2026, and the program has FDA fast track status.
Open‑label extension data in 341 SAD patients suggest fasedienol is generally well‑tolerated with encouraging exploratory efficacy signals, and the company estimates more than 1,500 subjects have received at least one dose, exceeding ICH E1 safety‑exposure guidelines. Vistagen also advances refisolone (non‑hormonal hot flashes/PMDD, U.S. IND open), itruvone (fast track for MDD), PH15 (mental‑fatigue psychomotor impairment), PH284 (cancer cachexia) and oral prodrug AV‑101 for NMDAR‑related disorders, largely aimed at partnering.
The company reports an aggregate market value of non‑affiliate common stock of about $137.7 million as of September 30, 2025, and 41,032,453 shares outstanding as of June 12, 2026. Vistagen holds a broad patent estate extending into the 2030s–2040s and has regional deals, including a fasedienol license in parts of Asia and an exclusive negotiation agreement in Japan for refisolone.
Vistagen Therapeutics reported a fiscal 2026 net loss of $69.7 million, up from $51.4 million, as it increased investment in its late-stage pherine pipeline. Research and development expense rose to $55.0 million, while general and administrative expense was $18.4 million.
Revenue was $1.3 million, primarily from sublicenses and other sources. Cash, cash equivalents, and marketable securities totaled $45.4 million as of March 31, 2026, and the company expects this to fund operations into 2027. Vistagen completed the randomized portion of its PALISADE-4 Phase 3 trial of fasedienol in social anxiety disorder, achieved ICH E1 safety exposure recommendations, reported preliminary positive data from the PALISADE-3 open-label extension, and received an FDA “Study May Proceed” letter to advance refisolone for menopausal vasomotor symptoms.
Vistagen Therapeutics reported that its clinical program for fasedienol nasal spray for acute treatment of social anxiety disorder has now met the minimum patient exposure levels recommended under ICH E1 safety guidance for long-term treatment of non-life-threatening conditions.
As of May 31, 2026, the company estimates that more than 1,500 subjects have received at least one dose of fasedienol, with over 300 exposed for at least six months and over 100 for at least 12 months, based on open-label safety studies and extension phases of its PALISADE-3, PALISADE-4 and repeat-dose trials.
Vistagen cautions that it has not yet aligned with the FDA on specific exposure requirements for a potential New Drug Application. It expects topline Phase 3 PALISADE-4 results in the second quarter of 2026 and topline Phase 2 repeat-dose results in the third quarter of 2026, which it believes could help support a potential future U.S. NDA submission if outcomes are successful.
Vistagen Therapeutics reported a Form 4 showing its Chief Medical Officer, Angel S. Angelov, received a grant of stock options for 150,000 shares of common stock at an exercise price of $0.5955 per share. The options expire on May 18, 2036 and were granted in connection with his appointment as Chief Medical Officer, with 25% vesting on May 18, 2027 and the remaining options vesting monthly over the following three years.
Vistagen Therapeutics, Inc. officer Angelov Angel S, the company’s Chief Medical Officer, has filed a Form 3, which is an initial statement of beneficial ownership for insiders. This filing reports his status as an officer, and no share purchases or sales are reported in the provided data.
Vistagen Therapeutics appointed Angel S. Angelov, M.D., MBA as Chief Medical Officer effective May 18, 2026. He brings over two decades of clinical development and medical affairs experience from roles at companies including Karuna Therapeutics, Neurocrine Biosciences, Novartis and Teva, as well as academic positions.
His compensation includes a starting annual base salary of $425,000, a $50,000 signing bonus paid in two tranches, and eligibility for an annual discretionary cash bonus targeted at 45% of base salary. He also received an inducement stock option grant to purchase 150,000 shares at an exercise price of $0.5955 per share, vesting over four years, in accordance with Nasdaq Listing Rule 5635(c)(4). Vistagen also entered into an indemnification agreement with him and issued a press release describing his appointment and the company’s late clinical-stage neuroscience focus.
Vistagen Therapeutics, Inc. Schedule 13G/A: This Amendment No. 1 updates beneficial ownership information for TCG Crossover I, TCG Crossover II, their general partners and Chen Yu, reporting shared voting and dispositive power in Vistagen common stock.
The filing lists specific share counts and ownership percentages for each reporting entity and for Chen Yu, and ties these figures to reported outstanding share counts "as of" February 11, 2026 and aggregated warrant issuable amounts described in the filing.
Vistagen Therapeutics reported preliminary positive data from the open-label extension of its PALISADE-3 Phase 3 study of fasedienol nasal spray for social anxiety disorder. In 341 adults using 3.2 µg as needed for up to 12 months, treatment was well-tolerated, with a 2.6% discontinuation rate due to adverse events and no events attributed to fasedienol. Most treatment-emergent side effects were mild or moderate, mainly headache and upper respiratory infection, and no serious adverse events were related to the drug.
Clinician-rated Liebowitz Social Anxiety Scale scores improved by 25.4 points at Month 4 from a very severe baseline of 99.2, with over half of patients achieving at least a 20‑point gain. Patient-reported Social Phobia Inventory scores improved by 12.4 points at Month 4 from a severe baseline of 48.7, with 55% reaching at least a 10‑point improvement. These benefits were seen even in participants who had not responded in the randomized portion of PALISADE-3, which previously failed its primary endpoint in a public speaking challenge.
Vistagen highlights ongoing late-stage development: PALISADE-4, another Phase 3 public speaking challenge study, has completed last patient visits and is expected to deliver topline data in the second quarter of 2026, while an exploratory repeat‑dose Phase 2 study is expected to report topline results in the third quarter of 2026. The company believes successful PALISADE results, together with evidence of sustained, clinically meaningful improvement, could support a potential New Drug Application for fasedienol in social anxiety disorder.
Vistagen Therapeutics reports that the last patient has completed the last visit in the randomized, double-blind, placebo-controlled portion of PALISADE-4, its U.S. Phase 3 trial of intranasal fasedienol for the acute treatment of social anxiety disorder. The open-label extension remains ongoing, allowing continued real-world use. Topline results from the randomized portion are expected in the second quarter of 2026.
The company refined the PALISADE-4 statistical analysis plan to incorporate each participant’s pre-dose Subjective Units of Distress Scale score as a baseline covariate, and the FDA indicated it has no comments on these refinements. Fasedienol has FDA Fast Track designation, and Vistagen believes PALISADE-4, if successful and combined with prior Phase 3 data, could support a future New Drug Application for social anxiety disorder.
Vistagen Therapeutics reported that the FDA issued a “Study May Proceed” letter under its U.S. Investigational New Drug application for refisolone nasal spray. This clearance allows the company to advance refisolone’s Phase 2 clinical development in the U.S. for menopausal vasomotor symptoms, or hot flashes.
The update highlights prior exploratory Phase 2a data from Mexico, where refisolone showed rapid, statistically significant reductions in hot flash frequency and severity versus placebo and was well-tolerated, supporting further development of this non-hormonal, intranasal women’s health candidate.