Axsome Therapeutics Says FDA Has Acknowledged Resubmission Of New Drug Application For AXS-07 For Acute Treatment Of Migraine
Portfolio Pulse from Benzinga Newsdesk
Axsome Therapeutics announced that the FDA has acknowledged the resubmission of its New Drug Application for AXS-07, a treatment for acute migraine. The FDA has classified it as a Class 2 resubmission with a PDUFA action goal date set for January 31, 2025.
September 04, 2024 | 11:04 am
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Axsome Therapeutics' resubmission of AXS-07 for migraine treatment has been acknowledged by the FDA as a Class 2 resubmission, with a PDUFA date of January 31, 2025.
The FDA's acknowledgment of the resubmission is a positive regulatory step for Axsome Therapeutics, potentially leading to approval of AXS-07. The set PDUFA date provides a timeline for investors, likely boosting short-term sentiment.
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