Core Insights - Zacks Premium provides tools for investors to enhance their stock market engagement and confidence, including daily updates, research reports, and stock screens [1][2] Zacks Style Scores - The Zacks Style Scores are indicators designed to help investors select stocks likely to outperform the market within 30 days, rated from A to F based on value, growth, and momentum characteristics [3] - Stocks with higher Style Scores have a better chance of outperforming the market [3] Value Score - The Value Style Score focuses on identifying undervalued stocks using financial ratios such as P/E, PEG, and Price/Cash Flow [4] Growth Score - The Growth Style Score emphasizes a company's financial health and future outlook, analyzing projected and historical earnings, sales, and cash flow to find stocks with sustainable growth [5] Momentum Score - The Momentum Style Score helps investors capitalize on price trends by analyzing short-term price changes and earnings estimate revisions [6] VGM Score - The VGM Score combines Value, Growth, and Momentum Scores, providing a comprehensive indicator for stock selection based on weighted styles [7] Zacks Rank - The Zacks Rank is a proprietary model that uses earnings estimate revisions to simplify portfolio building, with 1 (Strong Buy) stocks achieving an average annual return of +23.9% since 1988, outperforming the S&P 500 [8] - There can be over 800 stocks rated 1 or 2 on any given day, making it essential to utilize Style Scores for effective stock selection [9] Stock to Watch: Axsome Therapeutics - Axsome Therapeutics, a biopharmaceutical company, is rated 3 (Hold) with a VGM Score of A and a Momentum Style Score of A, having seen a 19.6% increase in share price over the past four weeks [12] - Two analysts have raised earnings estimates for fiscal 2025, with the Zacks Consensus Estimate increasing by $0.04 to -$3.83 per share, and an average earnings surprise of +8.5% [13]

Core Insights - Axsome Therapeutics has initiated the FORWARD Phase 3 trial for AXS-14 (esreboxetine) aimed at managing fibromyalgia, marking a significant step in addressing this chronic condition [1][2] Group 1: Trial Details - The FORWARD trial is a Phase 3, double-blind, placebo-controlled, multicenter study involving a randomized withdrawal design [2] - Patients will undergo a 12-week open-label treatment period followed by a randomized phase where they will either continue AXS-14 (8 mg) or switch to a placebo [2] - The primary endpoint is the time from randomization to loss of therapeutic response [2] Group 2: Fibromyalgia Overview - Fibromyalgia affects approximately 17 million people in the U.S., characterized by widespread pain, fatigue, and cognitive impairment [3] - The condition has a significant impact on quality of life and is associated with a considerable economic burden [3] - Current treatment options are limited, with over 50% of patients discontinuing treatment within the first year due to inadequate symptom control or side effects [3] Group 3: AXS-14 Profile - AXS-14 (esreboxetine) is a selective norepinephrine reuptake inhibitor being developed specifically for fibromyalgia management [4] - It is the SS-enantiomer of racemic reboxetine and is currently an investigational drug not yet approved by the FDA [4] Group 4: Company Overview - Axsome Therapeutics focuses on innovative treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for various conditions [5] - The company aims to address critical gaps in care and improve patient outcomes through differentiated products [5] - Axsome's mission is to tackle significant neurological and psychiatric challenges affecting over 150 million people in the U.S. [5]

Group 1 - The article does not provide any relevant content regarding the company or industry [1]

Financial Performance - Axsome Therapeutics reported preliminary net product revenue for Q4 2025 at $XX million, representing a YY% increase compared to Q4 2024[6] - For the full year 2025, the company achieved net product revenue of $ZZ million, up by AA% year-over-year[6] - The company has set a revenue guidance of $DD million for Q1 2026, reflecting a growth target of EE%[6] Product Development and Expansion - The company is focusing on expanding its product portfolio with new therapies expected to launch in 2026[6] - Axsome Therapeutics is investing in R&D, with a budget increase of BB% for the upcoming fiscal year to support new product development[6] - The company plans to enter new markets, targeting an expansion into CC countries by the end of 2026[6] - Axsome Therapeutics is exploring potential acquisitions to enhance its market position and product offerings[6] Operational Efficiency and Engagement - User data indicates a significant increase in patient engagement, with a growth rate of FF% in the last quarter[6] - The company is implementing new strategies to improve operational efficiency, aiming for a reduction in costs by GG%[6] Digital Marketing Initiatives - Axsome Therapeutics is committed to enhancing its digital presence, with plans to invest HH million in digital marketing initiatives[6]

Core Insights - Axsome Therapeutics, Inc. reported preliminary net product revenues for the fourth quarter and full year 2025, with total revenues expected to be $196.0 million and $638.5 million, reflecting annual growth rates of 65% and 66% respectively [2][3] Group 1: Financial Performance - AUVELITY is projected to generate net product sales of approximately $155.1 million for the fourth quarter and $507.1 million for the full year 2025 [6] - SUNOSI is expected to achieve net product revenue of around $36.7 million for the fourth quarter and $124.8 million for the full year 2025 [6] - SYMBRAVO is anticipated to have net product sales of about $4.1 million for the fourth quarter and $6.6 million for the full year 2025, following its commercial launch in June 2025 [6] Group 2: Company Overview - Axsome Therapeutics is focused on developing innovative treatments for central nervous system (CNS) disorders, with a portfolio that includes FDA-approved therapies for major depressive disorder, excessive daytime sleepiness, and migraines [4] - The company aims to address significant gaps in care and improve patient outcomes through differentiated products and novel mechanisms of action [4]

Core Insights - The article compares Halozyme Therapeutics (HALO) and Axsome Therapeutics (AXSM) to determine which stock offers better value for investors [1] Group 1: Zacks Rank and Earnings Outlook - Halozyme Therapeutics has a Zacks Rank of 2 (Buy), indicating a positive earnings outlook, while Axsome Therapeutics has a Zacks Rank of 3 (Hold) [3] - The Zacks Rank system emphasizes companies with positive earnings estimate revisions, suggesting that HALO has an improving earnings outlook [3] Group 2: Valuation Metrics - HALO has a forward P/E ratio of 9.51, significantly lower than AXSM's forward P/E of 398.07, indicating that HALO may be undervalued [5] - HALO's PEG ratio is 0.31, while AXSM's PEG ratio is 8.83, further suggesting that HALO is a more attractive investment based on expected earnings growth [5] - HALO's P/B ratio is 16.83 compared to AXSM's P/B of 114.57, reinforcing HALO's position as a better value option [6] Group 3: Value Grades - HALO has a Value grade of B, while AXSM has a Value grade of D, indicating that HALO is viewed more favorably by value investors [6] - The metrics analyzed suggest that HALO stands out in both Zacks Rank and Style Scores models, making it a more appealing choice for value investors [6]

Core Insights - The healthcare sector underperformed in 2025, but there are still solid investment opportunities in smaller biotech companies [1] - Axsome Therapeutics and Exelixis are highlighted as promising investment options for 2026 and beyond [2] Axsome Therapeutics - Axsome Therapeutics has made steady clinical and regulatory progress, with approved products including Auvelity for depression, Symbravo for migraines, and Sunosi for narcolepsy [3] - The company is close to earning approval for Auvelity in treating Alzheimer's disease agitation, which could address a significant unmet need, as approximately 5 million patients in the U.S. experience this condition [4] - Axsome's revenue for the first nine months of 2025 reached $442.5 million, marking a 65.8% increase year-over-year [7] - The company has several late-stage pipeline candidates, including AXS-12 for narcolepsy and AXS-14 for fibromyalgia, which could further boost revenue [6][8] Exelixis - Exelixis specializes in oncology, primarily generating revenue from Cabometyx, which is approved for various cancers, including liver and kidney cancer [9] - The company reported $1.7 billion in revenue for the first nine months of 2025, a 7.5% increase compared to the same period in 2024 [10] - Exelixis has successfully defended its patent rights, delaying generic competition until the next decade [10] - The company is developing new products, including Zanzalintinib for metastatic colorectal cancer, which has shown strong phase 3 results and could significantly impact sales [12][14] - Exelixis is expected to submit regulatory applications soon, which will help diversify its portfolio beyond Cabometyx [13]

Company Overview - Axsome Therapeutics, Inc. is a biopharmaceutical company focused on developing therapies for central nervous system disorders, particularly for conditions like depression and migraines [1] - The company is recognized for its innovative drug pipeline and strategic partnerships in a competitive landscape [1] Recent Transactions - On January 7, 2026, CEO Herriot Tabuteau sold 31,261 shares at $170.38 each, reducing his holdings to 7,229 shares [2] - Director Mark Saad sold 37,577 shares at $165.18 each on December 31, 2025, decreasing his ownership by 78.98% to 10,002 shares [2][5] Stock Performance - Axsome's stock opened at $178.69 and is currently priced at $170.69, reflecting a slight decrease of 0.69% [3] - The stock has traded between $168.02 and $173.73 recently, with a yearly low of $79.19 and a high of $184.40, indicating significant volatility [3] Financial Metrics - The company has a market capitalization of approximately $8.60 billion [4][5] - Axsome has a negative price-to-earnings (P/E) ratio of -38.26, while the price-to-earnings-growth ratio is at 16.17 [4] - Financial health indicators include a debt-to-equity ratio of 1.66, a quick ratio of 1.50, and a current ratio of 1.57, suggesting a stable liquidity position [4]

Core Viewpoint - Axsome Therapeutics' shares surged 22.8% following the FDA's acceptance of the supplemental new drug application for AXS-05, aimed at treating agitation in Alzheimer's disease [1][7]. Group 1: FDA Approval Process - The FDA has granted a priority review for the sNDA, with a decision expected by April 30, 2026, reducing the review period to six months [2][7]. - The sNDA is supported by a comprehensive clinical program, including data from four pivotal late-stage studies and a long-term safety study [3][7]. Group 2: Product Performance and Market Potential - AXS-05 is already approved for major depressive disorder and marketed as Auvelity, which generated $352 million in sales during the first nine months of 2025, reflecting a 77.1% year-over-year increase [8]. - Axsome is also exploring additional indications for Auvelity, including smoking cessation, with plans to initiate a pivotal study soon [9][10]. Group 3: Pipeline Developments - Axsome has received FDA feedback on AXS-12, a candidate for treating cataplexy in narcolepsy, with plans to submit a new drug application by January 2026 [11][12].

Company Overview - Axsome Therapeutics (AXSM) shares increased by 22.8% to close at $182.64, with notable trading volume compared to typical sessions, and a previous gain of 4.7% over the past four weeks [1][2] FDA Approval Update - The stock's rally followed the announcement that the FDA accepted and granted priority review for its supplemental new drug application for AXS-05, aimed at treating Alzheimer's disease agitation, with a final decision expected on April 30, 2026 [2] Financial Performance Expectations - The company is projected to report a quarterly loss of $0.75 per share, reflecting a year-over-year increase of 21.9%, while revenues are anticipated to reach $187.9 million, up 58.2% from the same quarter last year [3] Earnings Estimate Revisions - The consensus EPS estimate for the upcoming quarter has been revised 2.7% lower in the last 30 days, indicating a negative trend in earnings estimate revisions, which typically does not lead to price appreciation [4] Industry Context - Axsome is part of the Zacks Medical - Biomedical and Genetics industry, where Amgen (AMGN) finished the last trading session down 0.4% at $327.31, with a return of -2.9% over the past month [5] Amgen Financials - Amgen's consensus EPS estimate remains unchanged at $4.74, representing a year-over-year decline of 10.7%, and it also holds a Zacks Rank of 3 (Hold) [6]