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Vandana Singh

As Expected, FDA Rejects Axsome Therapeutics' Migraine Candidate

  • The FDA has issued a Complete Response Letter (CRL) to Axsome Therapeutics Inc's (NASDAQ:AXSM) AXS-07 for the acute treatment of migraine. 
  • The CRL did not identify or raise any concerns about the clinical efficacy or safety data in the NDA, and the FDA did not request any new clinical trials to support the approval of AXS-07.
  • Related: Axsome Poised To Receive FDA Rejection For Its Migraine Candidate, Shares Fall.
  • The principal reasons given in the CRL relate to chemistry, manufacturing, and controls (CMC) considerations. The CRL identified the need for additional CMC data on the drug product and manufacturing process. 
  • Axsome reported a Q1 FY22 cash balance of $84.7 million. It believes that its current cash and the remaining committed capital from the $300 million term loan facility are sufficient to fund anticipated operations into 2024.
  • Price Action: AXSM shares closed at $31.75 on Friday.
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