Jo Yi Chudy's questions to Vistagen Therapeutics Inc (VTGN) leadership • Q3 2025
Question
Jo Yi Chudy of Stifel questioned the rationale for the ongoing repeat-dose study of fasedienol, the expected outcomes, and any potential regulatory risks if a two-dose regimen appears more effective than a single dose.
Answer
COO Joshua Prince clarified that the repeat-dose study was requested by the FDA to evaluate the safety and potential efficacy of a second dose. He and CEO Shawn Singh conveyed that they do not anticipate regulatory issues if the single-dose PALISADE trials are successful, as the repeat-dose study is smaller and primarily intended to inform the product's label regarding real-world use. Prince noted that while some patients might benefit, receptor saturation could limit the additional effect of a second dose.