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Benzinga
Benzinga
Technology
Vandana Singh

Axsome Poised To Receive FDA Rejection For Its Migraine Candidate, Shares Fall

Axsome FDA Nasdaq Prescription Drug Sleep Disorder
  • The FDA has informed that Axsome Therapeutics Inc (NASDAQ:AXSM) chemistry, manufacturing, and controls issues identified during the review of AXS-07 remain unresolved.
  • The Company is seeking approval for AXS-07 for the acute treatment of migraine. 
  • Based on the time remaining in the review cycle, the Company expects to receive a Complete Response Letter concerning this marketing on or about the Prescription Drug User Fee Act target action date of April 30.
  • Also See: Axsome Acquires Sleep Disorder Drug From Jazz Pharma, Expanding Its Neuroscience Portfolio.
  • Last week, Axsome received and agreed to the Postmarketing Requirements/Commitments proposed by the FDA for the marketing application for its AXS-05.
  • AXS-05 is Axsome's product candidate for major depressive disorder. The Company anticipates potential FDA action on the NDA sometime in the second quarter. 
  • Price Action: AXSM shares are down 21.4% at $30.75 during the market session on the last check Monday.
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