FDA Accepts AXSM’s NDA Resubmission for Migraine Drug, Stock Up
Axsome Therapeutics, Inc. (NASDAQ: AXSM) announced that the FDA has accepted its resubmitted new drug application (NDA) seeking approval for AXS-07 for the acute treatment of migraine.
A final decision from the regulatory body is expected on Jan. 31, 2025. The FDA has designated the NDA resubmission as a Class 2 resubmission.
Shares of AXSM were up 6.6% on Sept. 4 following the announcement of the news.
Year to date, shares of Axsome have rallied 20.1% against the industry’s decrease of 0.9%.
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The FDA issued a complete response letter to the first NDA for AXS-07 in April 2022 as it identified issues related to the chemistry, manufacturing and controls.
The NDA re-submission for AXS-07 for the acute treatment of migraine was completed during the second quarter of 2024. The FDA has not requested any additional safety or efficacy data for the NDA resubmission.
The NDA re-submission …
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