Penny Stock Vistagen Keeps Regulatory Plans Alive Despite Anxiety Study Miss
Vistagen Inc. (NASDAQ:VTGN) on Monday reported that its 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.
However, the company identified a statistically significant benefit in a post-hoc analysis of patients with very severe social anxiety and now plans to pursue a revised regulatory strategy focused on long-term treatment.
PALISADE-4 Misses Primary And Secondary Endpoints
The trial enrolled 238 participants and used the Subjective Units of Distress Scale (SUDS) as its primary endpoint.
Fasedienol produced a least squares mean change from baseline of -9.5 compared with -11.4 for placebo, resulting in a difference of 1.9 that was not statistically significant (p=0.427).
The company also reported no treatment difference between fasedienol and placebo across the study’s secondary endpoints. Safety and tolerability findings remained consistent with those observed in previous placebo-controlled clinical trials.
Subgroup Analysis Shows Benefit In Patients With Very Severe Social Anxiety
In a post-hoc analysis involving 123 patients with very severe social anxiety, defined by a baseline Liebowitz Social Anxiety Scale (LSAS) score of 95 or higher, fasedienol demonstrated a nominally statistically significant improvement.
Patients receiving fasedienol recorded a least squares mean change of -12.8 on the SUDS compared with -3.7 for placebo, representing a difference of -9.1 (p=0.036).
Company Plans FDA Discussions On New Registrational Strategy
Based on results from the broader fasedienol development program, Vistagen said it intends to shift its focus from the acute treatment of social anxiety symptoms to the overall treatment of social anxiety disorder over time.
The company plans to meet with the U.S. Food and Drug Administration to discuss a potential registrational pathway that could be supported by a future multi-dose Phase 3 trial using the LSAS as the primary endpoint.
Vistagen said the proposed strategy would also rely on evidence from its positive PALISADE-2 Phase 3 trial, other placebo-controlled studies, and its aggregate safety database.
Separately, the company said its existing cash resources of $45.4 million are expected to fund operations into 2027 under its current operating plans and previously announced cost-management initiatives.
Beyond fasedienol, Vistagen’s pipeline includes Phase 2 programs for menopause-related vasomotor symptoms, major depressive disorder, psychomotor impairment due to mental fatigue, and cancer cachexia.
VTGN Stock Price Activity: Vistagen Therapeutics shares were down 71.21% at $0.21 at the time of publication on Tuesday, according to Benzinga Pro data.
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