Vistagen Therapeutics Says Fasedienol Clinical Program Exceeds ICH Exposure Thresholds

MT Newswires Live06-10

Vistagen Therapeutics (VTGN) said Tuesday that its clinical program for fasedienol nasal spray for acute social anxiety disorder met the minimum patient exposure requirements under the ICH E1 safety standard.

As of May 31, more than 1,500 subjects had received at least one dose of fasedienol, including over 300 with at least six months of exposure and more than 100 with at least 12 months of exposure, the company said.

Vistagen said it has yet to reach agreement with the US Food and Drug Administration on the specific patient exposure requirements needed to support a potential new drug application.

Topline data from the phase 3 PALISADE-4 trial are expected in Q2 2026, with results from the phase 2 repeat-dose study slated for Q3, the company added.

Vistagen Therapeutics shares were up over 2% in Wednesday premarket activity.

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