Vistagen achieves ICH E1 safety exposure minimum for fasedienol; over 1,500 subjects dosed

Vistagen Therapeutics, Inc.

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.

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