AXSM - Axsome to resubmit marketing application for migraine therapy in Q3 2023

• Axsome Therapeutics ( NASDAQ: AXSM ) announced Thursday its plans to resubmit a New Drug Application (NDA) for migraine therapy AXS-07 to the FDA in Q3 2023.
• The decision follows a Type A meeting AXSM held with the regulator to obtain FDA feedback and its agreement on its plans to respond to the previously issued Complete Response Letter with a new NDA submission.
• The company said the resubmission will address the issues mainly related to chemistry, manufacturing, and controls considerations, including the stability of newly manufactured commercial scale batches of AXS-07.
• NDA resubmission is expected to receive a Class 2 designation that will result in a six-month review.
• Read: In August, AXSM announced that the FDA approved its depression therapy Auvelity sending its shares sharply higher.

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