Boxed Warnings May Not Hinder This Depression Drug's Broad Market Penetration, Analyst Says

  • Last week, Axsome Therapeutics Inc's AXSM major depression candidate received the much-awaited FDA approval.
  • HC Wainwright notes that the approval comes roughly a year after the original Prescription Drug User Fee Act (PDUFA) decision date.
  • Auvelity (dextromethorphan HBr-bupropion HCl, formerly AXS-05) is the first and only rapid-acting oral medicine approved for major depressive disorder with the labeling of statistically significant antidepressant efficacy compared to placebo starting at one week.
  • Also Read: What SVB Says On Axsome's Strategy Review On Sunosi For Sleeping Disorder. 
  • The analyst reiterates the Buy rating while raising the price target from $180 to $210.
  • As pricing information for Auvelity is awaited, the analyst says that antidepressant agents with good efficacy data have historically experienced robust uptake and that the market remains a segment with high unmet need despite several having several generic agents.
  • Boxed warning (specifying suicidal ideation and behaviors) will not be a significant barrier to broad market penetration.
  • Price Action: AXSM shares are up 1.70% at $65.56 on the last check Tuesday.
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