secwatch.observer — SEC 8-K summary
======================================

Issuer:     Vistagen Therapeutics, Inc. (VTGN)
CIK:        0001411685
Form:       8-K
Filed at:   2026-06-09T21:04:52+00:00
Accession:  0001628280-26-041962
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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.
- Milestone supports safety database for NDA; FDA alignment on specific exposure requirements still pending.
- Topline results from PALISADE-4 Phase 3 trial expected Q2 2026; Phase 2 Repeat Dose study topline due Q3 2026.
- Fasedienol is a pherine nasal spray for acute treatment of social anxiety disorder; no new safety signals reported.
- CEO notes encouraging subject participation in open-label extensions and well-tolerated profile across trials.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1411685/000162828026041962/0001628280-26-041962-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1411685/000162828026041962/vtgn-20260609.htm
  HTML page:      https://secwatch.observer/filing/0001628280-26-041962

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer