Business UpdateJun 15, 2026, 04:41 PM
Vistagen Completes PALISADE-4 Phase 3 Trial; Reports FY26 Results
AI Summary
Vistagen Therapeutics announced significant progress in its clinical pipeline, including the completion of the randomized portion of its PALISADE-4 Phase 3 trial for fasedienol, with topline results anticipated in June 2026. The company also completed a Phase 2 repeat dose study for fasedienol and received FDA clearance to proceed with refisolone's clinical development for hot flashes. Financially, Vistagen reported a net loss of $69.7 million for fiscal year 2026, an increase from the prior year, with cash reserves expected to last into 2027.
Key Highlights
- Vistagen completed the randomized portion of its PALISADE-4 Phase 3 trial for fasedienol, with topline results expected in June 2026.
- The company completed the randomized portion of its fasedienol Phase 2 repeat dose study, with topline results expected in Q3 2026.
- Vistagen received FDA "Study May Proceed" clearance for refisolone's IND to develop it for vasomotor symptoms.
- Research and development expense increased to $55.0 million for FY26, up from $39.4 million in FY25.
- Net loss for fiscal year 2026 was $69.7 million, compared to $51.4 million in fiscal year 2025.
- Cash, cash equivalents, and marketable securities totaled $45.4 million as of March 31, 2026.
- The company expects its cash position to fund operations into 2027.
- Vistagen appointed Angel S. Angelov as CMO, Nick Tressler as CFO, and Elissa Cote as CCO.
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