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FDA approves Auvelity for Alzheimer's agitation, Axsome shares surge 12%

other · 2026-05-01

The FDA has approved Auvelity, an existing depression medication, as the first non-antipsychotic treatment for agitation in Alzheimer's disease. This decision drove Axsome Therapeutics' stock up 12%. Auvelity avoids the black box warning required for the only other approved treatment, making it a safer alternative. The drug is already on the market for major depressive disorder.

Key facts

  • FDA approved Auvelity for Alzheimer's agitation
  • Auvelity is already approved for depression
  • It is the first non-antipsychotic drug for this condition
  • The only other approved treatment carries a black box warning
  • Axsome Therapeutics shares rose 12% on the news

Entities

Institutions

  • FDA
  • Axsome Therapeutics

Sources