Axsome Therapeutics (NASDAQ: AXSM) has been a red-hot stock to own over the past 12 months. During that stretch, it has soared by around 75%, dwarfing the performance of the S&P 500, which is up by 15% over that same time frame. The healthcare company, which develops therapies for the central nervous system, has been generating strong results in recent quarters, giving investors plenty of reasons to be bullish on its future. Its next round of results come out on Feb. 23, when Axsome will report its quarte ...

Core Insights - Axsome Therapeutics has shown significant market performance over the past five years, driven by clinical and regulatory advancements, and is approaching large-cap status [1] - There remains potential for further investment in Axsome Therapeutics due to ongoing growth and new product developments [1] Group 1: Sales Growth - Axsome's revenue for the third quarter reached $171 million, reflecting a 63% increase compared to the same period last year [2] - The company's current product lineup includes Auvelity for depression, Sunosi for narcolepsy-related daytime sleepiness, and Symbravo for migraines, all contributing to strong sales growth [2][3] Group 2: Future Approvals - Axsome is pursuing new approvals and label expansions, including a new indication for Auvelity in treating Alzheimer's disease agitation, which has shown positive results in phase 3 studies and is under FDA consideration [4] - Sunosi has completed a phase 3 study for ADHD in adults, with plans for additional late-stage trials in related markets [5] Group 3: New Product Pipeline - The company is developing several other products, such as AXS-12 for cataplexy in narcolepsy and AXS-14 for fibromyalgia, which could significantly enhance sales potential [6] - The addressable market for Alzheimer's agitation is substantial, with over 5 million patients in the U.S. and currently only one FDA-approved treatment available [7]

Core Insights - Axsome Therapeutics Inc. (NASDAQ:AXSM) is recognized as a promising mid-cap stock by leading investors, with H.C. Wainwright raising its price target from $200 to $260 while maintaining a Buy rating [1] - The company reported interim unaudited financial results for Q4 2025, projecting total product revenue of approximately $196 million [1] Revenue Projections - Axsome anticipates overall product revenue of around $638.5 million for fiscal year 2025, representing a 66% increase compared to fiscal year 2024, surpassing H.C. Wainwright's estimate of $628.3 million [2] - The primary product, AUVELITY, is expected to generate net sales of about $155.1 million in Q4 and $507.1 million for the full year 2025, significantly exceeding the firm's annual sales estimate of $397 million [2] Performance of Other Products - Other products, such as SUNOSI, are also projected to perform well, with expected revenues of $36.7 million in Q4 and $124.8 million for the entire year [3] - Axsome Therapeutics focuses on developing novel therapies for central nervous system (CNS) disorders in the US [3]

Core Insights - Axsome Therapeutics, Inc. is set to report its financial results for Q4 and full year 2025 on February 23, 2026, before U.S. market opening [1] - A conference call will be held at 8:00 a.m. Eastern Time to discuss these results and provide a business update [1] Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system (CNS) disorders, aiming to deliver scientific breakthroughs and develop 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 development programs target serious neurological and psychiatric conditions affecting over 150 million people in the U.S. [3]

Core Insights - Axsome Therapeutics is experiencing significant sales growth for its lead drug, Auvelity, which is approved for major depressive disorder, contributing substantially to the company's revenue since its U.S. launch in 2022 [1][11] Sales Performance - Auvelity generated sales of $352 million in the first nine months of 2025, marking a 77% increase year-over-year, primarily due to higher unit sales volume [2][11] - Total product revenues are projected to be approximately $196 million for Q4 2025 and around $638.5 million for the full year, reflecting year-over-year increases of 65% and 66%, respectively [3] - Auvelity's net product sales are expected to reach about $155.1 million for Q4 2025 and $507.1 million for the full year [4] Product Development and Regulatory Updates - The FDA has accepted a supplemental new drug application (sNDA) for AXS-05 to treat agitation in Alzheimer's disease, with a decision expected by April 30, 2026 [5][11] - Auvelity is also being studied for label expansions in other CNS disorders, which could broaden its market reach and enhance future sales [4][5] Additional Products and Market Position - Axsome's narcolepsy drug, Sunosi, is contributing to revenue growth, with sales increasing by 29.1% year-over-year in the first nine months of 2025 [6][7] - Sunosi's net product revenues are anticipated to be around $36.7 million for Q4 2025 and $124.8 million for the full year [7] - The newly launched Symbravo, approved for migraine treatment, is expected to generate net product sales of approximately $4.1 million for Q4 2025 and $6.6 million for the full year [8] Competitive Landscape - The competitive environment remains challenging, with companies like Acadia Pharmaceuticals marketing therapies for CNS disorders, including its drug Nuplazid, which recorded sales of $505.7 million in the first nine months of 2025 [9][10] - Symbravo is likely to face competition from established migraine treatments from Pfizer and AbbVie, which may hinder its market adoption [12]

Core Viewpoint - The investor is focused on building a resilient, income-generating portfolio with a long-term growth mindset, emphasizing disciplined, fundamentals-driven investing and capital preservation while compounding returns over time [1]. Group 1: Investment Strategy - The investment approach is primarily long-only, blending dividend-paying equities, REITs, and other income strategies with selective growth opportunities [1]. - The investor prioritizes capital preservation alongside the compounding of returns over time [1]. Group 2: Background - The investor is based in Dubai and originally from India, indicating a diverse geographical perspective in investment strategies [1].

Core Viewpoint - The investor is focused on building a resilient, income-generating portfolio with a long-term growth mindset, emphasizing disciplined, fundamentals-driven investing and capital preservation while compounding returns over time [1]. Group 1: Investment Strategy - The investment approach is primarily long-only, blending dividend-paying equities, REITs, and other income strategies with selective growth opportunities [1]. - The investor prioritizes capital preservation alongside the compounding of returns over time [1]. Group 2: Background - The investor is based in Dubai and originally from India, indicating a diverse geographical perspective in investment strategies [1].

Core Viewpoint - Axsome Therapeutics Inc. (NASDAQ:AXSM) is identified as a promising mid-cap growth stock, with multiple analysts raising their price targets due to positive developments regarding its drug Auvelity and its potential FDA label expansion for Alzheimer's agitation [1][2][3]. Group 1: Analyst Ratings and Price Targets - Piper Sandler raised its price target on Axsome Therapeutics to $223 from $148, maintaining an Overweight rating, citing confidence in Auvelity's commercial potential and expected FDA label expansion by April 30 [1]. - Baird increased its price target for Axsome Therapeutics from $157 to $209 while keeping an Outperform rating, driven by an update to its financial model following preliminary Q4 2025 results that slightly exceeded expectations [2]. - Wells Fargo raised its price target from $157 to $193, also maintaining an Overweight rating, noting that Q4 2025 sales for Auvelity and Sunosi surpassed consensus estimates, which is expected to drive positive momentum for the stock [3]. Group 2: Drug Development and Market Potential - Auvelity is highlighted for its sustained momentum in the depression market and a long-term patent runway that ensures market exclusivity until 2039 [1]. - The probability of success for Auvelity's label expansion for Alzheimer's Disease Agitation was increased from 75% to 90% following the FDA's decision to grant a priority review [3]. Group 3: Company Overview - Axsome Therapeutics Inc. is a biopharmaceutical company focused on developing and delivering novel therapies for central nervous system (CNS) disorders in the United States [4].

Core Viewpoint - Axsome Therapeutics (AXSM) has experienced a significant stock price increase, attributed to positive sales forecasts and the initiation of a new clinical study [2][3]. Group 1: Stock Performance - Axsome Therapeutics shares rose 4.1% to close at $184.5, with trading volume significantly higher than usual, reflecting a 14.6% gain over the past four weeks [1]. - The stock's recent rally is linked to the announcement of preliminary fourth-quarter and full-year 2025 sales figures for its marketed products [2]. Group 2: Financial Expectations - The company is expected to report a quarterly loss of $0.73 per share, which is a year-over-year increase of 24%, while revenues are projected to be $190.18 million, marking a 60.1% increase from the same quarter last year [3]. - Despite the positive revenue growth expectations, the consensus EPS estimate has been revised slightly lower over the past 30 days, indicating a potential negative trend in earnings estimate revisions [4]. Group 3: Industry Context - Axsome Therapeutics is categorized within the Zacks Medical - Biomedical and Genetics industry, which includes other companies like Zealand Pharma A/S (ZLDPF) that has seen a decline of 12.5% over the past month [5]. - Zealand Pharma AS has an unchanged consensus EPS estimate of -$1.34, representing a significant year-over-year decline of 127.1% [6].

Core Insights - Axsome Therapeutics (AXSM) has initiated a phase III study named FORWARD to evaluate AXS-14 (esreboxetine) for managing fibromyalgia, marking a significant step in its drug development process [1][8] - AXS-14 is an investigational oral drug aimed at increasing norepinephrine levels in the brain to alleviate chronic pain and related symptoms associated with fibromyalgia [1] Study Details - The FORWARD study is a phase III double-blind, placebo-controlled withdrawal trial involving patients with fibromyalgia, where participants who respond to treatment during a 12-week open-label period will be randomized to either continue AXS-14 at 8 mg once daily or switch to placebo for up to 12 weeks [2] - The primary endpoint of the study is to measure the time from randomization to the loss of therapeutic response [2][8] Market Performance - Over the past year, AXSM's shares have increased by 89.4%, significantly outperforming the industry average rise of 18.7% [3] Regulatory Background - Axsome submitted a new drug application (NDA) for AXS-14 for fibromyalgia in May 2025, which was delayed from an earlier timeline of the first quarter of 2024 [5] - In June 2025, the FDA issued a Refusal to File (RTF) letter regarding the NDA, citing inadequacies in one of the placebo-controlled studies, prompting Axsome to initiate the FORWARD study to address these concerns [6][8] Disease Context - Fibromyalgia is a chronic neurological pain disorder affecting approximately 17 million people in the United States, characterized by widespread pain, fatigue, sleep disturbances, and other symptoms [7]