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Axsome completes pre-NDA meeting for AXS-07

  • Axsome Therapeutics (NASDAQ:AXSM) has completed a successful pre-New Drug Application (NDA) meeting with the FDA for AXS-07 for the acute treatment of migraine.
  • The purpose of the meeting was to reach an agreement with the Agency on the proposed content and format of the Company’s NDA submission including the clinical and nonclinical requirements.
  • The company remains on track to submit the planned NDA in Q4.

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Axsome Therapeutics, Inc.