Vistagen shares go through the roof on positive fasedienol trial results

US clinical-stage drug developer Vistagen (Nasdaq: VTGN) saw its shares go into the stratosphere, up as much as 1,272% and closing yesterday on a 677% boost to $13,05, after it released new data on its social anxiety disorder (SAD) candidate that had disappointed in a readout a year ago.

Vistagen announced positive top-line results from its Phase III PALISADE-2 trial evaluating the efficacy, safety, and tolerability of fasedienol (PH94B) nasal spray in adults diagnosed with SAD.

The trial met its primary endpoint, with fasedienol demonstrating a statistically-significant difference in average SUDS score during a public speaking challenge compared to placebo (p=0.015). The trial also met its secondary endpoint, demonstrating a statistically significant difference in the proportion of clinician-assessed responders between fasedienol and placebo as measured by the CGI-I scale (p=0.033). Fasedienol was well-tolerated and demonstrated a favorable safety profile consistent with all prior trials.