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

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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