Vistagen's PALISADE-4 Phase 3 Trial Fails to Meet Primary Endpoint

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Vistagen Therapeutics announced that its PALISADE-4 Phase 3 trial of intranasal fasedienol for acute treatment of social anxiety disorder did not meet its primary endpoint. Fasedienol failed to show a statistically meaningful improvement over placebo based on change from baseline in SUDS scores, and no treatment advantage was seen across secondary endpoints. The drug maintained a favorable safety and tolerability profile consistent with earlier studies. Separately, the company reported fiscal year 2026 results with research and development expenses rising to $55.0 million from $39.4 million, general and administrative expenses increasing to $18.4 million from $17.1 million, and a net loss of $69.7 million compared with $51.4 million in the prior year. As of March 31, 2026, Vistagen held $45.4 million in cash, cash equivalents, and marketable securities, expected to fund operations into 2027.

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VistaGen Therapeutics Inc
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PALISADE-4 Phase 3 trial of fasedienol failed to meet primary endpoint, showing no statistical improvement over placebo.