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Axsome Therapeutics announces anticipated milestones

Regulatory and Commercial: AXS-07 for migraine, NDA resubmission 1H 2024; AXS-14 for fibromyalgia, NDA submission 4Q 2023 – 1Q 2024. Clinical Trial Readouts: Phase 3 SYMPHONY trial of AXS-12 in narcolepsy 4Q 2023; Phase 3 ADVANCE-2 trial of AXS-05 for Alzheimer’s disease agitation 1H 2024; Phase 3 FOCUS trial of solriamfetol in ADHD in adults 2H 2024. Clinical Trial Initiations: Phase 3 trial of solriamfetol for binge eating disorder 4Q 2023; Phase 3 trial of solriamfetol in shift work disorder 1Q 2024; Pivotal Phase 2/3 trial of AXS-05 for smoking cessation 4Q 2023 – 1Q 2024

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