secwatch.observer — SEC 8-K summary
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Issuer:     Vistagen Therapeutics, Inc. (VTGN)
CIK:        0001411685
Form:       8-K
Filed at:   2026-09-22T20:22:14+00:00
Accession:  0001628280-26-063046
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Vistagen reports positive OLE data from PALISADE-4; LSAS improved 31.4 pts at month 4
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- Safety: N=322; discontinuation due to AEs 1.6% (5/322), no fasedienol-related serious AEs; headache most common TEAE (18.0%).
- LSAS mean improvement from baseline 99.3: 20.2 pts (M1), 24.6 (M2), 29.1 (M3), 31.4 (M4); 65% achieved ≥20-pt gain by M4.
- SPIN mean improvement from baseline 48.5: 10.5 pts at M1, 14.9 pts at M4; 59% had ≥10-pt improvement.
- Company plans FDA meeting this quarter to discuss proposed new registrational Phase 3 trial of fasedienol for social anxiety disorder.
- Treatment well-tolerated up to 6x/day as-needed for 12 months; no new safety signals on labs, ECGs, or vitals.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1411685/000162828026063046/0001628280-26-063046-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1411685/000162828026063046/vtgn-20260922.htm
  HTML page:      https://secwatch.observer/filing/0001628280-26-063046

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