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 is presenting results from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 for Alzheimer's disease agitation at the 2025 AAN Annual Meeting [1][2] - The company is also showcasing data from the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy and a network meta-analysis comparing SYMBRAVO® to oral CGRPs for migraine treatment [2] Alzheimer's Disease Agitation - Title of the presentation: "Efficacy and Safety of AXS-05 in Alzheimer's Disease Agitation: A Phase 3 Randomized Withdrawal Double-Blind Placebo-Controlled Study" [3] - Oral presentation scheduled for April 7, 2025, from 11:27 to 11:33 a.m. PT [3] - Poster presentation on the same day from 12:09 to 12:45 p.m. PT [3] Narcolepsy - Title of the presentation: "AXS-12 for the Treatment of Narcolepsy: Topline Results from the Phase 3 SYMPHONY Trial" [3] - Oral presentation scheduled for April 8, 2025, from 10:45 to 11 a.m. PT [3] - Additional poster presentation titled "CRESCENDO: Results from a Survey of Symptom Burden and Quality of Life in Patients with Narcolepsy Type 1" on April 8, 2025, from 8 to 9 a.m. PT [3] Migraine - Title of the presentation: "Comparative Efficacy of AXS-07 vs. Gepants for Acute Treatment of Migraine: A Network Meta-Analysis" [4] - Poster presentation scheduled for April 8, 2025, from 5 to 6 p.m. PT [4] - SYMBRAVO is a novel oral medication approved for acute migraine treatment, combining MoSEIC™ meloxicam and rizatriptan [5][6] Company Overview - Axsome Therapeutics focuses on developing innovative treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for major depressive disorder, narcolepsy, and migraine [34][35] - AXS-05 is an investigational drug for Alzheimer's disease agitation and smoking cessation, utilizing a proprietary formulation of dextromethorphan and bupropion [32] - AXS-12 is under development for narcolepsy and has received FDA Orphan Drug Designation [33]