Independent Biostatisticians Recommend Vistagen Continue Late-Stage Anxiety Trial

  • Vistagen Therapeutics Inc VTGN completed an interim analysis of PALISADE-2, its second Phase 3 trial assessing drug candidate PH94B as an acute treatment of anxiety in adults with Social Anxiety Disorder.
  • The analysis concluded that PALISADE-2 should continue as planned.
  • Related: VistaGen Says Data From Late-Stage Anxiety Study 'Not Consistent' With Prior Positive Phase 2 Study.
  • Independent biostatisticians reviewed unblinded data from the 140 subjects who completed PALISADE-2 before the Company paused enrollment in the study in July 2022, following the announcement of topline results from its first Phase 3 trial, PALISADE-1.
  • The independent biostatisticians recommended that Vistagen continue PALISADE-2 as planned to the full enrollment of 208 subjects without adjusting the study size. 
  • Vistagen expects topline results from PALISADE-2 in the first half of 2023.
  • Price Action: VTGN shares are up 21.8% at $0.20 on the last check Thursday.
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