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

The FDA has informed that Axsome Therapeutics Inc 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.