Vistagen reports positive OLE data from PALISADE-4; LSAS improved 31.4 pts at month 4

Vistagen Therapeutics, Inc.

Safety: N=322; discontinuation due to AEs 1.6% (5/322), no fasedienol-related serious AEs; headache most common TEAE (18.0%).
LSAS mean improvement from baseline 99.3: 20.2 pts (M1), 24.6 (M2), 29.1 (M3), 31.4 (M4); 65% achieved ≥20-pt gain by M4.
SPIN mean improvement from baseline 48.5: 10.5 pts at M1, 14.9 pts at M4; 59% had ≥10-pt improvement.
Company plans FDA meeting this quarter to discuss proposed new registrational Phase 3 trial of fasedienol for social anxiety disorder.
Treatment well-tolerated up to 6x/day as-needed for 12 months; no new safety signals on labs, ECGs, or vitals.

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