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NASDAQ: VTGN Vistagen Therapeutics, Inc. 8-K

Vistagen completes patient enrollment in Phase 3 social anxiety trial for fasedienol

Filed May 8, 2026 · Period ending May 8, 2026 · ~1 min read

2 key changes 2 high relevance 2 sections

Key Changes

  • high

    Last patient completed final visit in PALISADE-4, the Phase 3 trial testing fasedienol nasal spray for acute treatment of social anxiety disorder. Trial completion enables data analysis and potential regulatory submission.

    8-K: Press Release verify on EDGAR →
  • high

    PALISADE-4 was a randomized, double-blind, placebo-controlled study. Completion of the controlled portion marks a key milestone in the drug development timeline.

    8-K: Press Release verify on EDGAR →

Summary

Vistagen Therapeutics announced completion of patient follow-up in PALISADE-4, its Phase 3 clinical trial evaluating fasedienol nasal spray as an acute treatment for social anxiety disorder. The last patient has finished their final visit in the randomized, double-blind, placebo-controlled portion of the study, marking a critical milestone in the drug's development path.

For retail investors, this completion is significant because it positions Vistagen to analyze trial data and potentially move toward a New Drug Application (NDA) submission to the FDA. Success in this trial could open a substantial market opportunity in social anxiety treatment, where acute-use nasal spray options are limited.

The company's ability to demonstrate efficacy versus placebo will determine whether fasedienol can advance to commercialization. Investors should watch for top-line data readout from PALISADE-4, expected in the coming months. The trial results will reveal whether fasedienol met its primary endpoints and will directly impact the company's regulatory and commercial prospects.

Section-by-Section Diff

Event · Item 8.01 — Other Events

~96 words

Item 8.01 — Other Events filed; see Key Changes for terms.

1 Added
Added PALISADE-4 trial completion high

Added in current filing · verify on EDGAR →

the last patient has completed their last visit in the randomized, double-blind, placebo-controlled portion of PALISADE-4, the Company’s Phase 3 clinical trial evaluating fasedienol nasal spray for the acute treatment of social anxiety disorder

Vistagen announced that the final patient has finished their last visit in the controlled portion of PALISADE-4, a Phase 3 trial testing fasedienol nasal spray as an acute treatment for social anxiety disorder. This milestone marks completion of patient enrollment and follow-up in the randomized, placebo-controlled study phase, positioning the company to analyze trial data and potentially advance toward regulatory submission.

Event · Item 9.01 — Financial Statements and Exhibits

~100 words

Vistagen filed an 8-K attaching a press release dated May 8, 2026; no material event details disclosed in the filing body.

1 Added
Added Press release attachment medium

Added in current filing · verify on EDGAR →

Press Release issued by Vistagen Therapeutics, Inc., dated May 8, 2026

The 8-K discloses that a press release dated May 8, 2026 has been issued and attached as Exhibit 99.1. The filing body does not describe the content of the press release, so the nature of the disclosed event cannot be determined from this 8-K alone.

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Figures/quotes linked to EDGAR · Narrative written by AI · Jun 10, 2026 · How we verify