Vistagen Inc. (NASDAQ:VTGN) surged on Wednesday after preliminary findings from the open-label extension portion of its PALISADE-4 Phase 3 trial evaluating intranasal fasedienol for acute social anxiety disorder.
The company’s phase 3 PALISADE-4 trial of intranasal fasedienol for the acute treatment of social anxiety disorder did not meet its primary endpoint in the overall study population.
Data released in June, however, identified a statistically significant benefit in a post-hoc analysis of patients with very severe social anxiety.
Robust Safety Profile Observed in Trial
The extension trial involved 322 adult participants.
Analysis through a July 24, 2026 data cut-off revealed no new drug-related safety findings or serious adverse events linked to fasedienol over 12 months of exposure.
Overall discontinuation due to adverse events reached 1.6%, with zero participant withdrawals attributed to the drug itself. More than 95% of adverse events were mild or moderate in severity.
Progressive Efficacy In Symptom Reduction
On the clinician-administered Liebowitz Social Anxiety Scale, where subjects entered with a very severe mean baseline score of 99.3, mean improvements reached 20.2 points at month one, 24.6 points at month two, 29.1 points at month three, and 31.4 points by month four.
At month four, 65% of subjects experienced a 20-point or greater improvement. Mean score changes at month two reflected a clinically meaningful reduction of two severity categories across fear, anxiety, and avoidance subscales.
Patient-reported assessments on the Social Phobia Inventory further supported these findings.
Starting from a severe baseline mean score of 48.5, participants showed a 10.5-point mean improvement at month one and a 14.9-point improvement at month four.
Analyst View
The biopharmaceutical company is preparing to meet with the FDA during the current quarter to discuss a proposed new registrational Phase 3 clinical trial.
William Blair noted that PALISADE-4 OLE data add incremental evidence to fasedienol’s clinical data package supportive of a treatment benefit, though cautioned against overinterpretation of the open-label data.
Analyst Myles Minter wrote that it is hard to gain conviction around open-label fasedienol data currently given a lack of placebo control, and Phase 3 studies have shown mixed data.
Minter further notes that it is unclear whether a single additional registrational study using LSAS as the primary endpoint would be sufficient to support filing, or whether the agency could require
two additional pivotal studies given the proposed shift away from the historical PALISADE study design (PALISADE-2 was a positive study).
William Blair maintains the Market Perform rating.
VTGN Price Action: Vistagen Therapeutics shares were up 58.55% to $0.39 during premarket trading on Wednesday, according to Benzinga Pro data.
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