Core Insights - Axsome Therapeutics has acquired exclusive global rights to AZD7325, a novel oral GABAA receptor α2,3 subtype-selective positive allosteric modulator, from AstraZeneca, enhancing its neuroscience portfolio and targeting epilepsy treatment [1][2][3] Company Overview - Axsome Therapeutics is focused on developing innovative treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for major depressive disorder, narcolepsy, and migraine, as well as multiple late-stage development programs [5] Transaction Details - The acquisition was executed through Axsome's purchase of a 100% equity interest in Baergic Bio, Inc., which includes a $0.3 million upfront payment to Baergic Bio shareholders and potential milestone payments totaling up to $79 million [3] - AstraZeneca will receive a cash upfront payment in the single-digit millions and is eligible for additional milestone payments and royalties on global net sales of AZD7325 [3] Clinical Development - AZD7325 has shown anti-convulsant effects in preclinical models and has a favorable safety profile based on studies involving over 700 patients [2] - Axsome plans to initiate Phase 2 trial-enabling activities for AZD7325 in 2026 [1][2] Market Need - Epilepsy affects approximately 3.4 million people in the U.S., with about 150,000 new cases diagnosed annually, highlighting the urgent need for innovative treatment options [4]

Financial Performance - Total net product revenue reached $171.0 million, a 63% year-over-year increase[12, 27] - AUVELITY net product sales were $136.1 million, representing a 69% year-over-year growth[12, 27, 46] - SUNOSI net product revenue amounted to $32.8 million, a 35% year-over-year increase[12, 27, 56] - SYMBRAVO net product sales were $2.1 million[12, 27] - Cash and cash equivalents stood at $325.3 million as of September 30, 2025[12] Pipeline Development & Regulatory Milestones - An sNDA for AXS-05 in Alzheimer's disease agitation has been submitted to the FDA[12, 25, 74] - An NDA submission for AXS-12 for cataplexy in narcolepsy is anticipated in 4Q 2025[12, 25, 109] - A Phase 3 trial of solriamfetol in children and adolescents with ADHD is anticipated in 4Q 2025[12, 25, 82] Strategic Focus & Market Potential - The company is targeting therapeutic areas with high unmet needs, with potential approvals through 2028[11] - The company estimates a combined peak sales potential of >$16 billion across its pipeline[21]

Core Insights - Axsome Therapeutics reported a total net product revenue of $171.0 million for Q3 2025, reflecting a 63% year-over-year growth and a 14% sequential growth from Q2 2025 [3] - The company has submitted a supplemental NDA for AXS-05 for the treatment of Alzheimer's disease agitation, addressing a significant unmet medical need [2][11] Financial Highlights - Total net product revenue for Q3 2025 was $171.0 million, up from $104.8 million in Q3 2024, marking a 63% increase year-over-year [3] - AUVELITY sales reached $136.1 million in Q3 2025, a 69% increase from $80.4 million in Q3 2024 [3] - SUNOSI generated $32.8 million in revenue for Q3 2025, representing a 35% year-over-year growth [3] - SYMBRAVO achieved $2.1 million in sales during its first full quarter of commercialization [3] - The net loss for Q3 2025 was $47.2 million, or $(0.94) per share, an improvement from a net loss of $64.6 million, or $(1.34) per share, in Q3 2024 [3] Commercial Highlights - AUVELITY prescriptions increased by 46% year-over-year, totaling approximately 209,000 in Q3 2025 [9] - Payer coverage for AUVELITY is approximately 85%, with 75% in commercial channels and 100% in government channels [9] - SUNOSI prescriptions rose by 12% year-over-year, with approximately 53,000 prescriptions written in Q3 2025 [9] - SYMBRAVO had approximately 5,000 prescriptions written in its first full quarter [9] Development Pipeline - AXS-05 is being developed for Alzheimer's disease agitation and has received FDA Breakthrough Therapy designation [11] - Axsome plans to initiate a Phase 3 trial of solriamfetol in ADHD in pediatric patients in Q4 2025 [12] - AXS-12 is set for NDA submission for the treatment of cataplexy in narcolepsy in Q4 2025 [13] - A Phase 3 trial of AXS-14 in fibromyalgia is also planned for Q4 2025 [17] Cash Position - Cash and cash equivalents totaled $325.3 million as of September 30, 2025, compared to $315.4 million at the end of 2024 [8]

Group 1 - The event is the Fifth Annual TD Cowen Novel Mechanisms in Neuropsychiatry and Epilepsy Summit, featuring Axsome Therapeutics [1] - Axsome Therapeutics has made significant progress in both commercial and development aspects over the past year [2] - The company is expected to provide insights into future expectations for investors, particularly looking towards the end of 2025 and early 2026 [2] Group 2 - In Q2, Axsome Therapeutics reported net sales of $150 million, with Auvelity contributing $120 million and Sunosi $30 million [4] - The recent launch of SYMBRAVO generated approximately $400,000 in its first 2.5 weeks [4]

Financial Performance - Axsome Therapeutics reported quarterly losses of 47 cents per share, significantly better than the analyst consensus estimate of losses of $1.07 per share [1] - The company achieved quarterly sales of $150.04 million, exceeding the analyst consensus estimate of $140.33 million [1] Company Commentary - The CEO of Axsome Therapeutics highlighted strong underlying demand for their medicines, effective commercial execution, solid regulatory progress, and advancements in their neuroscience pipeline [2] - The recent approval and launch of SYMBRAVO for migraine, along with the accelerating performance of AUVELITY for depression and SUNOSI for excessive daytime sleepiness, were noted as positive developments [2] Stock Performance and Analyst Ratings - Following the earnings announcement, Axsome Therapeutics shares fell by 3.4% to trade at $102.89 [3] - Analysts have adjusted their price targets for Axsome Therapeutics, with RBC Capital maintaining an Outperform rating and raising the price target from $184 to $189, and B of A Securities maintaining a Buy rating with a price target increase from $173 to $176 [5]

Financial Performance & Projections - Axsome reported Net Product Revenue of $150 million in 2Q 2025, a 72% increase compared to $872 million in 2Q 2024 [21] - AUVELITY Net Product Sales reached $1196 million in 2Q 2025, an 84% increase from $650 million in 2Q 2024 [21] - SUNOSI Net Product Revenue was $30 million in 2Q 2025, a 40% increase compared to $221 million in 2Q 2024 [21] - SYMBRAVO Net Product Sales were $04 million in 2Q 2025 [21] - The company estimates a combined peak sales potential of $165 billion across its differentiated portfolio [16] Clinical & Regulatory Milestones - The company commercially launched SYMBRAVO in the US in June 2025 [20] - Positive topline results were achieved from the EMERGE Phase 3 trial of SYMBRAVO in oral CGRP non-responders in 1Q 2025 [20] - Positive topline results were achieved from the FOCUS Phase 3 trial of solriamfetol in ADHD in adults in 1Q 2025 [20] - Topline results were achieved from the PARADIGM Phase 3 trial of solriamfetol in MDD in 1Q 2025 [20] - An sNDA submission for AXS-05 in Alzheimer's disease agitation is expected in 3Q 2025 [20] - An NDA submission for AXS-12 in narcolepsy is expected in 4Q 2025 [20] Market & Pipeline - The company is developing new indications across approved products and has Phase 3 development programs ongoing [13] - The company plans to initiate a Phase 3 trial of solriamfetol in ADHD in pediatric patients in 4Q 2025 [20] - The company plans to initiate a Phase 3 trial of solriamfetol in MDD with EDS in 4Q 2025 [20] - The company plans to initiate a Phase 3 trial of AXS-14 in fibromyalgia in 4Q 2025 [20] - The company plans to initiate a Phase 2/3 trial of AXS-05 in smoking cessation in 4Q 2025 [20]

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 hosting its Frontiers in Brain Health R&D Day to showcase its CNS pipeline targeting various psychiatric and neurological conditions [1][2] - The event features presentations from six expert clinicians discussing clinical data from the company's pipeline programs [2] - Axsome Therapeutics focuses on developing differentiated products with novel mechanisms of action to improve patient outcomes in CNS disorders [4][5] Company Overview - Axsome Therapeutics is a biopharmaceutical company specializing in the treatment of central nervous system (CNS) conditions [4] - The company has FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine [5] - Axsome's pipeline addresses serious neurological and psychiatric conditions affecting over 150 million people in the United States [5] Event Details - The R&D Day is intended for institutional investors and sell-side analysts, with a live webcast available for broader access [3] - Presentations will cover conditions such as Alzheimer's disease, fibromyalgia, ADHD, and narcolepsy, with insights from leading experts in the field [2][4]

Core Viewpoint - Axsome Therapeutics is celebrating its achievements in the treatment of central nervous system (CNS) disorders by ringing the NASDAQ opening bell, highlighting its innovative pipeline and recent product launch [1][2]. Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on CNS conditions, aiming to address critical gaps in care with differentiated products [3]. - The company has an industry-leading neuroscience portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine [3]. - Axsome's late-stage development programs target a wide range of serious neurological and psychiatric conditions affecting over 150 million people in the U.S. [3]. Recent Developments - The opening bell ceremony coincides with Axsome's Frontiers in Brain Health R&D Day, showcasing its late-stage CNS product candidates and the recent availability of SYMBRAVO by prescription in the U.S. [2]. - The event emphasizes the company's commitment to improving the lives of patients with serious CNS conditions [2].

Core Insights - Axsome Therapeutics, Inc. is hosting its Frontiers in Brain Health R&D Day on July 21, 2025, to showcase its innovative late-stage CNS pipeline [1][2] - The event will feature discussions from physician key opinion leaders on current indications in neurology and psychiatry, along with an overview of clinical development programs by Axsome's management team [2] Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system (CNS) disorders, with a portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine [4] - The company aims to address significant gaps in care by developing differentiated products that lead to meaningful advancements in patient outcomes, impacting over 150 million people in the United States [4]