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.

Analyst Calendar