Axsome to Resubmit AXS-07 NDA Based on Successful FDA Type A Meeting

 Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, announced that, following a Type A meeting with the U.S. Food and Drug Administration (FDA), it intends to resubmit its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine in the third quarter of 2023.

The purpose of the Type A meeting was to obtain the FDA’s feedback and agreement on the Company’s plan to address the issues raised in the previously received Complete Response Letter (CRL) to support a resubmission of the AXS-07 NDA. The issues principally related to chemistry, manufacturing, and controls (CMC) considerations. Based on the FDA feedback, the Company will include new CMC information, including stability data on newly manufactured commercial scale batches of AXS-07, in its resubmission package. The resubmission package may also include additional clinical pharmacology information. The Company expects the NDA resubmission to be designated as Class 2 which would be subject to a six-month review. No additional clinical efficacy or safety trials have been requested by the FDA for a resubmission of the NDA.

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