secwatch.observer — SEC 8-K summary
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Issuer:     Vistagen Therapeutics, Inc. (VTGN)
CIK:        0001411685
Form:       8-K
Filed at:   2026-05-12T11:44:41+00:00
Accession:  0001628280-26-033883
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Vistagen reports positive preliminary OLE data for fasedienol in SAD; well-tolerated up to 12 months
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- OLE safety (n=341): discontinuation due to AEs 2.6%; no SAEs related to fasedienol; TEAEs >5%: headache 10.9%, URI 11.4%.
- LSAS mean improvement: 16.3 pts at Month 1, 25.4 pts at Month 4; 56% had >=20 pt improvement at Month 4.
- SPIN mean improvement: 7.9 pts at Month 1, 12.4 pts at Month 4; 55% had >=10 pt improvement at Month 4.
- Baseline LSAS mean 99.2 (very severe SAD); baseline SPIN mean 48.7 (severe); improvements seen on both fear/avoidance subscales.
- Non-responders in randomized portion showed comparable LSAS improvement: Month 1 =13.4, Month 4 =20.8, 50% >=20 pts.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1411685/000162828026033883/0001628280-26-033883-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1411685/000162828026033883/vtgn-20260512.htm
  HTML page:      https://secwatch.observer/filing/0001628280-26-033883

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