Vistagen's Big Breakthrough: Says Single Administration Of Nasal Spray Candidate Can Potentially Reduce Anxiety Symptoms, Stock Skyrockets

Vistagen Therapeutics Inc VTGN released topline results from its Phase 3 PALISADE-2 trial evaluating the efficacy, safety, and tolerability of fasedienol (PH94B) nasal spray in adults diagnosed with social anxiety disorder (SAD).

The company says it is the first positive U.S. Phase 3 study of an investigational therapy for social anxiety disorder in over 15 years.

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). 

Fasedienol-treated patients demonstrated a statistically significant greater change in mean SUDS score (least-squares (LS) mean = -13.8) compared to placebo (LS mean = -8.0), for a difference between groups of -5.8.

The trial also met its secondary endpoint, demonstrating a statistically significant difference in the proportion of clinician-assessed responders between fasedienol and placebo (p=0.033). 

Fasedienol was well-tolerated and demonstrated a favorable safety profile consistent with all prior trials.

Over 25 million Americans are living with social anxiety disorder.

Vistagen's PH80, one of the company's five investigational neuroactive nasal sprays, demonstrated statistically significant efficacy versus placebo in an exploratory Phase 2A study for the acute treatment of hot flashes (vasomotor symptoms) in women diagnosed with menopausal hot flashes.

Price Action: VTGN shares are up 1142.3% at $20.72 during the premarket session on the last check Monday.