NEW YORK, July 09, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it will report its financial results for the second quarter of 2025 on Monday, August 4, 2025, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update. To participate in the live ...

NEW YORK, June 20, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today is joining with the Alzheimer’s disease advocacy community to raise awareness of the growing impact of Alzheimer’s disease in the United States and the importance of brain health during this year’s Alzheimer’s & Brain Awareness Month. “Alzheimer’s & Brain Awareness Month offers the perfect opportunity for all Ame ...

NEW YORK, June 18, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that data from across the SYMBRAVO (meloxicam and rizatriptan) clinical program will be presented at the 67 Annual Scientific Meeting of the American Headache Society (AHS), being held June 19- 22, 2025, in Minneapolis, Minnesota. Details for the presentations are as follows: Title: Efficacy of SYMBRAVO ...

SYMBRAVO represents a novel multi-mechanistic approach to treating migraine that addresses multiple pathways underlying a migraine attack SYMBRAVO On My Side offers comprehensive patient support services including access and prescription drug support NEW YORK, June 10, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that SYMBRAVO (meloxicam and rizatriptan) is now avai ...

Group 1: Summit Therapeutics - Summit Therapeutics' shares have increased over 1,000% in the past three years, primarily due to the progress of ivonescimab, an investigational cancer medicine [2] - Ivonescimab has shown positive results in several phase 2 and phase 3 studies in China and is already approved there, contributing to Summit's market cap of $13.6 billion despite no revenue generation [2][6] - The drug has produced Phase 3 results comparable to Keytruda for non-small cell lung cancer, indicating significant market potential [4] - Ivonescimab is being tested for multiple cancer types, suggesting a robust pipeline for Summit Therapeutics [5] - The company anticipates U.S. approval for ivonescimab within three years, with potential for further approvals in the next decade [6] Group 2: Axsome Therapeutics - Axsome Therapeutics has seen stock market gains of nearly 350% over the past three years due to significant clinical and regulatory milestones [7] - The company’s revenue increased by 62% year over year to $121.5 million in the first quarter, driven by the approval of Auvelity for major depressive disorder and the acquisition of Sunosi for narcolepsy [8] - Axsome is expected to transform its product lineup with new approvals and label expansions in the next three years, including positive trial results for several candidates [9] - The company is conducting multiple clinical studies that could lead to further positive data and regulatory submissions, indicating a strong late-stage pipeline [10]

Core Viewpoint - Axsome Therapeutics has reached a settlement with Hetero Labs regarding patent litigation over its product SUNOSI, allowing Hetero to market a generic version under specific conditions starting in 2040 [1][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, and migraines [3]. Settlement Details - The settlement permits Hetero to sell a generic version of SUNOSI starting on or after September 1, 2040, if pediatric exclusivity is granted, or on or after March 1, 2040, if not, contingent upon FDA approval [1]. - The agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review [2]. Ongoing Litigation - Axsome continues to pursue similar patent litigation against other parties related to SUNOSI in the U.S. District Court for the District of New Jersey [2].

Summary of Axsome Therapeutics (AXSM) 2025 Conference Call Company Overview - **Company**: Axsome Therapeutics (AXSM) - **Date of Conference**: May 13, 2025 - **Key Speakers**: Mark Jacobsen (COO), Nick Pizzi (CFO), Jason Gerber (Analyst) Key Points Industry and Product Launches - **Avelity (MDD)**: - The company is over two years into the launch and is experiencing a growth trajectory with ongoing initiatives to drive further growth [4][5] - Expansion of the field force to approximately 300 representatives was completed in Q1, expected to impact new prescriptions (NBRx) positively [5][8] - The company anticipates a national patient-provider program (PPP) campaign in the second half of the year to further catalyze growth [6] - **Symbravo (Migraine)**: - Launch is targeted for June 2025, with preparations underway and field force training in progress [36][37] - Peak sales expectations are between $500 million to $1 billion, compared to Avelity's $1 billion to $3 billion for MDD [35] Financial Performance and Projections - **Revenue Growth**: - Revenue growth is outpacing operating expense growth, with expectations for continued operating leverage into 2025 and 2026 [9] - The company is currently at 63% coverage in the commercial space, with a goal to exceed 80% [14][15] - Gross to net (GTN) in Q1 was in the mid-50s, expected to remain constant throughout the year despite seasonality [16] Market Dynamics and Competitive Landscape - **Payer Negotiations**: - The company is pleased with ongoing discussions with payers, aiming for long-term value rather than immediate coverage [13][14] - The efficacy of Avelity is a key factor in negotiations, with a strategy focused on maintaining net pricing [13] - **Market Access**: - Anticipated access in the Medicare Part D channel for Avelity, with expectations of around 70% coverage for total prescriptions [28] - The company is assessing potential targeting in long-term care facilities, which could enhance market penetration [31] Clinical Development and Regulatory Updates - **Alzheimer's Agitation Label Expansion**: - The company is preparing for a supplemental NDA (sNDA) submission in Q3 2025, with positive feedback from the FDA on the clinical program [22][24] - Three positive studies have been completed, supporting the filing [25] - **AXS-12 for Narcolepsy**: - The company plans to file for AXS-12 in the second half of 2025, with a robust clinical data package from multiple studies [47][48] Strategic Considerations - **Long-term Strategy**: - The company emphasizes a long-term approach to product value and market positioning, particularly in the context of evolving payer dynamics and competitive pressures [13][19] - The expansion of the field force is seen as a critical component for enhancing engagement with primary care clinicians [18] Additional Insights - **Market Segmentation**: - The company recognizes the distinct market dynamics for migraine treatments compared to MDD, with different refill patterns and prescribing behaviors [38][39] - There is a focus on ensuring that the product reaches patients effectively, with considerations for market access dynamics and clinician experiences [42][44] Conclusion - Axsome Therapeutics is positioned for growth with strategic initiatives in place for its key products, Avelity and Symbravo. The company is actively engaging with payers and preparing for significant product launches while maintaining a focus on long-term value and market access.

Core Viewpoint - Axsome Therapeutics is collaborating with Mental Health America to raise awareness and promote action during Mental Health Month, highlighting the importance of mental health and the impact of mental health conditions in the U.S. [1][3] Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on developing innovative treatments for central nervous system (CNS) disorders, aiming to improve the lives of individuals with serious conditions that are difficult to treat [4][7]. - 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, along with multiple late-stage development programs targeting serious neurological and psychiatric conditions affecting over 150 million people in the U.S. [7] Mental Health Statistics - Nearly 1 in 4 adults in the U.S. live with a mental illness, and more than 1 in 8 individuals aged 12 or older reported feeling depressed in the past two weeks, indicating a significant prevalence of mental health issues [3]. - Approximately 90% of individuals living with depression experience difficulties in work, home, or social activities due to their symptoms, which complicates daily life [3] Advocacy and Resources - Axsome is promoting resources for individuals and communities to take action regarding mental health, including Mental Health America's Action Guide, online screening tools, youth leadership programs, and opportunities to become mental health advocates [4][6]. - The 988 Suicide & Crisis Lifeline is highlighted as a confidential support service available 24/7, connecting individuals in crisis with trained counselors [5].