Axsome's Depression Candidate Scores FDA Nod, Stock Surges To 52-High

  • The FDA has approved Axsome Therapeutics Inc's AXSM Auvelity (dextromethorphan HBr -bupropion HCl) extended-release tablets for major depressive disorder (MDD) in adults.
  • Auvelity is the first and only rapid-acting oral medicine approved for the treatment of MDD with the labeling of statistically significant antidepressant efficacy compared to placebo starting at one week.
  • Related: Axsome Therapeutics Rallies 40% On FDA Product Label Proposal, But Analyst Remains Skeptical.
  • The rapid antidepressant effects of Auvelity have been sustained at all subsequent time points.
  • Auvelity is the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for treating MDD.
  • Axsome anticipates Auvelity to be commercially available in the U.S. in Q4 of 2022.
  • The product is protected by a robust patent estate extending to at least 2037-2040 and was studied in a comprehensive clinical program that included more than 1,100 depression patients.
  • Price Action: AXSM shares are up 26.10% at $53.50 during the premarket session on the last check Friday.
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