Core Insights - Axsome Therapeutics, Inc. is showcasing six presentations at Psych Congress 2025, focusing on innovative neuroscience products for CNS disorders [1][6] Group 1: Major Depressive Disorder - Presentation on Auvelity (dextromethorphan 45 mg-bupropion 105 mg) in patients with Major Depressive Disorder, led by Dr. Anita H. Clayton [2] Group 2: Alzheimer's Disease Agitation - Presentation on the efficacy and safety of AXS-05 in Alzheimer's Disease Agitation from the ACCORD-2 Phase 3 study, led by Dr. Jeffrey Cummings [3] Group 3: Narcolepsy - Multiple presentations on AXS-12, including its impact on symptom severity and functional impairment in narcolepsy from the Phase 3 SYMPHONY Trial, led by Dr. Michael Thorpy [5] - ENCORE study results on AXS-12 in narcolepsy, led by Dr. Richard Bogan [5] - Analysis of residual symptom burden in narcolepsy patients satisfied with treatment from the CRESCENDO Survey, led by Dr. Michael Thorpy [5] Group 4: Obstructive Sleep Apnea - Presentation on the effects of Solriamfetol on neuropsychological outcomes in patients with Obstructive Sleep Apnea from the real-world SURWEY study [4] Company Overview - Axsome Therapeutics is focused on developing differentiated products for CNS conditions, with FDA-approved treatments for major depressive disorder, narcolepsy, and obstructive sleep apnea, addressing serious neurological and psychiatric conditions impacting over 150 million people in the U.S. [6]

Core Insights - Axsome Therapeutics reported strong financial performance for Q2 2025, with total net product revenue of $150.0 million, reflecting a 72% year-over-year growth and a 24% sequential increase [4][9] - The company highlighted the successful launch of SYMBRAVO for migraine treatment and the continued growth of AUVELITY for depression and SUNOSI for excessive daytime sleepiness [3][4] - Axsome is on track for significant regulatory submissions, including AXS-05 for Alzheimer's disease agitation in Q3 2025 and AXS-12 for narcolepsy in Q4 2025 [3][4] Financial Highlights - Total net product revenue for Q2 2025 was $150.0 million, up from $87.2 million in Q2 2024 [4] - AUVELITY sales reached $119.6 million, an 84% increase year-over-year, while SUNOSI generated $30.0 million, a 35% increase [4] - The net loss for Q2 2025 was $48.0 million, or $(0.97) per share, compared to a net loss of $79.3 million, or $(1.67) per share, in Q2 2024 [9][29] Commercial Highlights - AUVELITY's market access expanded by 28 million new covered lives, achieving approximately 83% overall payer coverage [10] - SYMBRAVO launched on June 10, 2025, with initial sales of $0.4 million and a GPO contract signed for potential formulary coverage [4][10] - SUNOSI prescriptions increased by 13% year-over-year, with payer coverage at approximately 83% [10] Development Pipeline - AXS-05 is being developed for Alzheimer's disease agitation and has received FDA Breakthrough Therapy designation [13][15] - AXS-12 is targeted for cataplexy in narcolepsy, with an NDA submission anticipated in Q4 2025 [17] - The company is advancing multiple late-stage programs, including trials for ADHD, binge eating disorder, and fibromyalgia [12][14][18] Corporate Updates - Axsome resolved patent litigation with Hetero Labs regarding SUNOSI, allowing for future generic sales under specific conditions [22] - The company hosted a research and development day featuring expert discussions on its late-stage pipeline [22] - Axsome's cash and cash equivalents totaled $303.0 million as of June 30, 2025, down from $315.4 million at the end of 2024 [9][27]

Core Insights - Axsome Therapeutics, Inc. is presenting seven studies at the SLEEP 2025 conference, focusing on AXS-12 and solriamfetol, which are aimed at treating central nervous system disorders [1] Group 1: AXS-12 Presentations - AXS-12 is being evaluated in a Phase 3 open-label extension and randomized-withdrawal trial for narcolepsy, with topline results presented by Dr. Richard Bogan [2] - The impact of AXS-12 on symptom severity and functional impairment in narcolepsy is being discussed, with results from the Phase 3 SYMPHONY trial presented by Dr. Michael Thorpy [2] - A subgroup analysis from the CRESCENDO survey highlights residual symptom burden in patients with narcolepsy who are satisfied with treatment, also presented by Dr. Michael Thorpy [2] Group 2: Solriamfetol Presentations - The effects of solriamfetol on neuropsychological outcomes in patients with obstructive sleep apnea are being presented in the real-world SURWEY study by Dr. Yaroslav Winter [3] - Real-world usage of solriamfetol for excessive daytime sleepiness in patients with obstructive sleep apnea in the U.S. is being discussed, led by Dr. Yang Zhao [3] Group 3: Product Information - AXS-12 (reboxetine) is a selective norepinephrine reuptake inhibitor under development for narcolepsy, with FDA Orphan Drug Designation granted [4][5] - Solriamfetol is a dopamine and norepinephrine reuptake inhibitor being developed for multiple conditions, including ADHD and excessive sleepiness associated with shift work disorder [6] Group 4: Company Overview - Axsome Therapeutics is focused on developing innovative treatments for CNS conditions, with a portfolio that includes FDA-approved therapies for major depressive disorder and excessive daytime sleepiness [7]

Core Insights - Axsome Therapeutics, Inc. is presenting three innovative neuroscience programs at the ASCP 2025 Annual Meeting, focusing on treatments for central nervous system disorders [1][22] Group 1: AUVELITY - AUVELITY is an oral NMDA receptor antagonist approved for treating major depressive disorder (MDD) in adults, containing dextromethorphan (45 mg) and bupropion (105 mg) [3][4] - The mechanism of action for AUVELITY in treating depression is not fully understood, but it has received Breakthrough Therapy designation from the FDA for MDD [3][22] - AUVELITY is not approved for use in children and is specifically indicated for MDD [4][5] Group 2: AXS-05 - AXS-05 is being studied for its efficacy and safety in treating agitation associated with Alzheimer's disease through a Phase 3 randomized-withdrawal double-blind placebo-controlled study [2][22] - The lead author for this study is Dr. Jeffrey Cummings, Vice Chair of Research at UNLV [2] Group 3: Solriamfetol - Solriamfetol is being evaluated for excessive daytime sleepiness in patients with narcolepsy and obstructive sleep apnea, particularly those reporting anxiety and depression [2][22] - The lead author for this study is Dr. Ulf Kallweit, Assistant Professor of Neurology at Witten/Herdecke University, Germany [2]

Financial Performance & Pipeline - Axsome reported a total net product revenue of $121.5 million in 1Q 2025, representing a 62% year-over-year growth compared to 1Q 2024[16] - AUVELITY net product sales reached $96.2 million in 1Q 2025, reflecting an 80% year-over-year growth[16, 18] - SUNOSI net product revenue was $25.2 million in 1Q 2025, a 17% increase year-over-year[16, 18] - The company's cash and cash equivalents stood at $300.9 million as of March 31, 2025, expected to fund operations into cash flow positivity[16] - Axsome anticipates peak sales potential of $16.5 billion driven by current commercial and late-stage assets[13] Regulatory & Clinical Milestones - SYMBRAVO was approved in the U S for the acute treatment of migraine in January 2025, with commercial launch anticipated in June 2025[16, 17, 23] - An NDA for AXS-14 for fibromyalgia was submitted to the FDA[16] - A supplemental NDA submission for AXS-05 in Alzheimer's disease agitation is on track for 3Q 2025[16, 61] - An NDA submission for AXS-12 for cataplexy in patients with narcolepsy is anticipated in 2H 2025[16, 96] - Positive topline results were announced for the FOCUS Phase 3 trial of solriamfetol in ADHD and the EMERGE Phase 3 trial of SYMBRAVO in oral CGRP non-responders[16, 70] Market & Therapeutic Areas - Approximately 7 million people in the U S are affected by Alzheimer's disease[56] - Agitation is reported in approximately 70% of people with Alzheimer's disease[58] - An estimated 22 million people in the U S are affected by ADHD, including approximately 7 million children aged 3-17 years old[7, 67] - Approximately 17 million people in the U S are affected by fibromyalgia[7, 101]