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]

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].

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]

Core Insights - The company is currently awaiting an important decision regarding the filing for Auvelity and its application for AD agitation, which is a significant topic for stakeholders [1] - The company confirmed that a supplemental New Drug Application (sNDA) was submitted, and they are now waiting to provide further updates on this matter [1] - The expectation is that if the sNDA is accepted, it will undergo a standard review due to the current resource constraints and bandwidth considerations at the FDA, which are independent of the submitted package [2]

Axsome Therapeutics FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Event**: FY Conference on December 03, 2025 Key Points Industry and Product Updates - **Auvelity and Alzheimer's Disease (AD) Agitation**: - Axsome is awaiting an acceptance decision for the supplemental new drug application (SNDA) for Auvelity in AD agitation, which was submitted in early November [3][5][10] - The expectation is for a standard review due to FDA resource constraints, despite having three positive trials and breakthrough therapy designation [10][11] - The company believes the trial package is robust, consisting of one randomized parallel group study and two randomized withdrawal studies [10][12][22] Commercialization Strategy - **Sales Force Expansion**: - Currently, Axsome has approximately 300 sales representatives detailing for Major Depressive Disorder (MDD) and plans to expand the team upon approval for AD agitation [24][26] - The peak sales opportunity for AD agitation is estimated between $1.5 billion and $3 billion, while MDD is estimated at $1 billion to $3 billion, totaling $2.5 billion to $6 billion [30][32] - A discrete field force team will be established for long-term care facilities, recognizing the comorbidity between MDD and AD agitation [32][34] Market Access and Coverage - **Access to Auvelity**: - Currently, there is 100% access in the government channel and 75% in the commercial channel, leading to an overall 85% total covered lives [47][47] - The majority of prescriptions are expected to come from the government channel, with high-quality access anticipated for the AD agitation indication [47][123] Direct-to-Consumer (DTC) Campaign - **DTC Campaign for Auvelity**: - A national TV DTC campaign launched in September has shown positive results, with new prescriptions (NBRXs) increasing from 2,000 to over 2,800 per week [75][78] - The campaign is expected to continue through 2026, with adjustments made based on market conditions [79][100] Product Performance and Market Position - **Auvelity in MDD**: - Over 50% of prescriptions are now for monotherapy, with 15% first-line and 35% second-line usage [103][108] - The gross-to-net (GTN) improved from mid-50s% in Q1 and Q2 to high 40s% in Q3, with expectations for a slight uptick in Q4 [122][123] Pipeline Developments - **Solriamfetol**: - Axsome is excited about the potential of Solriamfetol in various CNS settings, with studies underway for ADHD, MDD with excessive daytime sleepiness, and binge eating disorder [159][161][186] - The company anticipates starting a pediatric ADHD study this quarter and expects top-line results for binge eating disorder next year [174][190] New Product Development - **GABA-A Alpha 2/3 Modulator**: - Axsome is exploring the value proposition of a new GABA-A modulator for epilepsy and psychiatric indications, with preclinical work already underway [200][206] - The company is taking an opportunistic approach to expand its early-stage pipeline [211][220] Conclusion - Axsome Therapeutics is strategically positioned with a robust pipeline and commercialization plans, focusing on expanding its market presence in both existing and new indications while maintaining a strong emphasis on data-driven decision-making and market access strategies.

Core Viewpoint - Axsome Therapeutics reported a wider-than-expected loss in Q3 2025, but revenues surged significantly due to strong sales of its drug Auvelity, raising questions about the sustainability of this positive trend leading up to the next earnings release [2][3][12]. Financial Performance - Axsome incurred a loss of $0.94 per share in Q3 2025, which was wider than the Zacks Consensus Estimate of a loss of $0.82, compared to a loss of $1.34 per share in the same quarter last year [2]. - Total revenues increased by 63% year-over-year to $171 million, surpassing the Zacks Consensus Estimate of $164 million, primarily driven by strong Auvelity sales [3][4]. - Net product revenues reached $169.8 million, reflecting a 63.7% year-over-year increase, while royalty revenues totaled $1.2 million [4]. Product Sales Breakdown - Auvelity sales amounted to $136.1 million, marking a 69% year-over-year increase and a 14% sequential increase, with approximately 209,000 prescriptions recorded, a 46% increase year-over-year [5]. - Sunosi's net product sales were $32.8 million, up 35% from the previous year, with total prescriptions growing 12% year-over-year [6]. - Symbravo generated $2.1 million in sales in its first full quarter since launch [6]. Expenses and Cash Position - Research and development expenses decreased by 11.5% year-over-year to $40.2 million, attributed to the completion of label expansion studies for Sunosi [7]. - Selling, general, and administrative expenses rose by 57.1% year-over-year to $150.2 million due to increased commercial activities for Auvelity and ongoing launch activities for Symbravo [7]. - As of September 30, 2025, Axsome had cash and cash equivalents of $325.3 million, up from $303 million as of June 30, 2025 [8]. Market Sentiment and Estimates - Recent estimates for Axsome have trended downward, with a consensus estimate shift of -23.81% [9]. - The stock has a Growth Score of A but lags in Momentum with an F, resulting in an aggregate VGM Score of C [11]. - Axsome holds a Zacks Rank 3 (Hold), indicating expectations for an in-line return in the coming months [12]. Industry Comparison - Axsome operates within the Zacks Medical - Biomedical and Genetics industry, where Gilead Sciences reported revenues of $7.77 billion, reflecting a 3% year-over-year increase [13]. - Gilead's expected earnings for the current quarter indicate a -2.1% change from the previous year, with a Zacks Rank 3 (Hold) and a VGM Score of A [14].

Group 1: Axsome Therapeutics - Axsome Therapeutics has shown strong clinical and regulatory progress, with a 63% year-over-year revenue increase to $171 million in Q3 [3][6] - The company’s main growth driver is Auvelity, approved for major depressive disorder, and it has received approval for Symbravo, a migraine medication [4][3] - Axsome estimates a potential of over $16 billion in peak sales across all its targeted indications, indicating a large addressable market [6][7] - The company has several late-stage pipeline candidates, including AXS-12 for narcolepsy, which could further enhance its growth prospects [6][8] Group 2: Exelixis - Exelixis specializes in cancer medicine, with Cabometyx as its primary product, approved for multiple indications, contributing to a 10.8% year-over-year revenue increase to $597.8 million in Q3 [9][10] - The company successfully won a lawsuit to keep generic competition for Cabometyx off the market until 2030, boosting its medium-term outlook [10] - Exelixis is developing new cancer therapies, including zanzalintinib for metastatic colorectal cancer, which has shown promise in clinical trials [12][13] - The ongoing development of new treatments and the upward sales trajectory of Cabometyx could enhance Exelixis's stock performance in the coming years [13]

Core Insights - The article emphasizes the potential of investing in smaller, lesser-known biotech companies alongside established market leaders, highlighting Viking Therapeutics and Axsome Therapeutics as promising candidates for growth in the biotech sector [1][2]. Viking Therapeutics - The weight loss market is projected to grow from $15 billion last year to $150 billion by 2035, driven by breakthroughs and increasing demand for obesity-related treatments [3]. - Viking Therapeutics is developing VK2735, a dual GLP-1/GIP agonist, currently in phase 3 trials for subcutaneous use, with promising efficacy observed in mid-stage trials for an oral formulation [4]. - The company is also working on another weight-loss candidate in preclinical studies and plans to initiate human clinical trials next year, alongside VK2809, which has completed phase 2 studies for metabolic dysfunction-associated steatohepatitis [7]. Axsome Therapeutics - Axsome Therapeutics has achieved significant clinical and regulatory advancements, with third-quarter revenue reaching $171 million, a 63% year-over-year increase, primarily due to its depression medication, Auvelity [9]. - Auvelity, launched in 2022, is expected to achieve blockbuster status in treating depression and is awaiting approval for use in Alzheimer's disease agitation, with potential peak sales estimated between $1.5 billion to $3 billion [10][11]. - The company has a robust pipeline with other approved products and ongoing late-stage trials, including AXS-12 for narcolepsy and AXS-14 for fibromyalgia, which are expected to enhance financial performance [12][13].

Core Insights - Axsome Therapeutics reported a loss of $0.94 per share in Q3 2025, which was wider than the expected loss of $0.82, but an improvement from the loss of $1.34 per share in the same quarter last year [1][6] - Total revenues increased by 63% year over year to $171 million, surpassing the consensus estimate of $164 million, driven by strong sales of Auvelity [2][6] Financial Performance - Product revenues reached $169.8 million in Q3, reflecting a 63.7% year-over-year increase, while royalty revenues were $1.2 million [4] - Auvelity sales amounted to $136.1 million, up 69% year over year, with approximately 209,000 prescriptions recorded, marking a 46% increase from the previous year [5][6] - Sunosi generated net product sales of $32.8 million, a 35% increase from the prior year, with total prescriptions growing 12% year over year [7] Expenses and Cash Position - Research and development expenses were $40.2 million, down 11.5% from the previous year, while selling, general, and administrative expenses rose 57.1% to $150.2 million [9] - As of September 30, 2025, the company had cash and cash equivalents of $325.3 million, up from $303 million as of June 30, 2025 [10] Pipeline Developments - Axsome is conducting label expansion studies for Auvelity and has filed a supplemental new drug application for AXS-05 for Alzheimer's agitation [11] - The company plans to initiate pivotal studies for AXS-05 in smoking cessation and has multiple candidates in development for various CNS disorders, including AXS-12 and AXS-14 [12][13] - Solriamfetol is being evaluated in phase III studies for ADHD and MDD, with top-line data expected in 2026 for binge eating disorder and shift work disorder [14][15] Market Performance - Year to date, Axsome's shares have increased by 60.5%, significantly outperforming the industry average rise of 12.1% [2]