regulatory
confidence high
sentiment positive
materiality 0.70
FDA accepts Axsome's NDA resubmission for AXS-07 migraine treatment; PDUFA date Jan 31, 2025
Axsome Therapeutics, Inc.
- FDA acknowledged Class 2 resubmission of NDA for AXS-07 for acute migraine treatment.
- PDUFA goal date set for January 31, 2025.
- AXS-07 is a novel oral drug candidate for acute migraine.