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]

Total preliminary 4Q and full year 2025 net product revenue of $196.0 million and $638.5 million, respectively, representing 65% and 66% annual growth, respectively  AUVELITY® preliminary 4Q and full year 2025 net product sales of $155.1 million and $507.1 million, respectively SUNOSI® preliminary 4Q and full year 2025 net product revenue of $36.7 million and $124.8 million, respectively SYMBRAVO® preliminary 4Q and full year 2025 net product sales of $4.1 million and $6.6 million, respectively NEW YORK, J ...

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]

Market Overview - U.S. stock markets closed for New Year's Day on January 1, 2026, with no trading activity, leading to cautious investor sentiment following a strong 2025 [1] - Futures markets indicated a slight decline, with S&P 500 futures down 0.2%, Dow Jones futures down 0.1%, and Nasdaq futures down 0.3% as of December 31, 2025 [2] 2025 Market Performance - Major U.S. stock indexes closed lower on December 31, 2025, with the Nasdaq Composite down 0.8%, S&P 500 down 0.7%, and Dow Jones down 0.6%, marking a modest pullback [3] - Despite the late-year dip, 2025 was a strong year for Wall Street, with the Nasdaq gaining approximately 20%, S&P 500 rising roughly 16%, and Dow Jones climbing about 13% [4] - Notable performers included Micron Technology with a 239% increase, Palantir up 135%, AMD gaining 77%, Alphabet rising 65%, and Nvidia increasing by 39% [4] Upcoming Economic Data - Key economic data releases include U.S. Construction Spending for November on January 2, ISM Manufacturing Index for December on January 5, ADP Employment Report and ISM Non-Manufacturing Composite on January 7, and U.S. Employment Report on January 9 [6] Company Developments - NIO Inc. reported record deliveries of 48,135 vehicles in December, a 54.6% year-over-year increase, and total deliveries for 2025 reached 326,028 vehicles, up 46.9% [11] - Trump Media & Technology Group announced a partnership with a cryptocurrency exchange, resulting in a 5% share price increase [11] - Nike shares advanced 4.1% after its CEO purchased approximately $1 million worth of shares [11] - Disney entered a partnership with OpenAI, becoming the first major content licensing partner for Sora, and made a $1 billion equity investment in OpenAI [11] - Micron Technology's shares declined by 2.5% despite strong annual performance [11]

Core Viewpoint - Axsome Therapeutics has received priority review designation from the FDA for its AXS-05 application aimed at treating agitation in Alzheimer's disease, with a target action date set for April 30, 2026, leading to a significant stock price increase of 22.75% and a market capitalization of $9.2 billion [1][3]. Group 1: Company Overview - Axsome Therapeutics (NASDAQ: AXSM) is a biopharmaceutical company focused on treating central nervous system (CNS) diseases, with AXS-05 being a key product under review for Alzheimer's agitation [3][5]. - The company was founded by Herriot Tabuteau, who has a background in both medicine and finance, allowing for a unique perspective on project evaluation [6][8]. - Axsome's growth strategy targets the significant unmet medical needs in CNS disorders, with an estimated 150 million people in the U.S. affected by conditions like depression and Alzheimer's [9]. Group 2: Product Development and Financials - AXS-05 is a novel oral investigational drug combining dextromethorphan and bupropion, currently in development for treating agitation in Alzheimer's disease and smoking cessation [5]. - The company has not yet achieved profitability, reporting a net loss of $247 million for the 12 months ending June 2025, but has generated $495 million in revenue, reflecting a 70% year-over-year increase [10]. - The company aims to push five new drugs to approval by 2028, with peak sales potential for its existing product portfolio estimated at $16.5 billion [10]. Group 3: Key Products and Market Position - Auvelity, Axsome's flagship antidepressant, shows rapid efficacy within one week, contrasting with traditional antidepressants that take 6-8 weeks, leading to a stock surge of 65% post-approval [11]. - The company executed a strategic acquisition of Sunosi for $53 million, later recouping $66 million by transferring rights in Europe and the Middle East, showcasing effective financial maneuvering [11]. - The upcoming AXS-05 approval could fill a significant market gap for treating agitation in Alzheimer's, addressing the limitations of current antipsychotic medications [11].

Core Insights - Axsome Therapeutics shares experienced a significant increase, closing the year with a rise of over 20% following the announcement of key developments [1] Group 1: FDA Approvals and Designations - The U.S. FDA granted priority review designation for Axsome's AXS-05 drug, aimed at treating agitation in Alzheimer's disease, which addresses a significant unmet medical need [3][4] - AXS-05 is already approved for major depressive disorder (MDD) and has seen a 69% year-over-year sales growth in Q3, contributing to 80% of Axsome's revenue for that quarter [3][8] - The FDA has set a target action date of April 30, 2026, for AXS-05, providing a clear timeline for potential market entry [4] Group 2: Pipeline Developments - Axsome's AXS-12, a drug for treating narcolepsy, is also progressing, with FDA meeting minutes indicating that the regulatory data package is acceptable for a new drug application (NDA) submission expected next month [5][6] - The positive news regarding both AXS-05 and AXS-12 has led to increased investor interest in Axsome stock [6]