Regulatory and Commercial: AXS-07 for migraine, NDA resubmission 2Q 2024; AXS-14 for fibromyalgia, NDA submission 2Q 2024; Clinical Trial Topline Results: Phase 3 ADVANCE-2 trial of AXS-05 for Alzheimer’s disease agitation 2H 2024; Phase 3 open-label safety extension trial of AXS-12 in narcolepsy 2H 2024; Phase 3 FOCUS trial of solriamfetol in ADHD in adults 2H 2024; Phase 3 PARADIGM trial of solriamfetol in major depressive disorder 2025; Phase 3 ENGAGE trial of solriamfetol in binge eating disorder 2025; Phase 3 EMERGE trial of AXS-07 in migraine with inadequate response to oral CGRP inhibitors 2H 2024; Clinical Trial Initiations and Progress: Phase 3 trial of solriamfetol in shift work disorder, initiation 2Q 2024; Phase 3 ACCORD-2 trial of AXS-05 for Alzheimer’s disease agitation, enrollment completion mid-year 2024; Pivotal Phase 2/3 trial of AXS-05 for smoking cessation, initiation 2024.
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