VistaGen says fasedienol SAD program meets ICH E1 minimum long-term safety exposure thresholds

PUBT·06/09/2026 12:30:48

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VistaGen reported its fasedienol nasal spray program in social anxiety disorder has met ICH E1 minimum long-term safety exposure benchmarks.
As of May 31, 2026, estimated exposure exceeded thresholds for single-use, 6-month, and 12-month follow-up, supporting a potential NDA safety package.
No new efficacy results were presented; PALISADE-4 Phase 3 topline data are expected in Q2 2026.
Topline results from a Phase 2 repeat-dose study are scheduled for Q3 2026, a key readout for repeat-use positioning.
FDA alignment on specific exposure requirements for an NDA submission has not been completed.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. VistaGen Therapeutics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260609888048) on June 09, 2026, and is solely responsible for the information contained therein.

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