Core Viewpoint - Axsome Therapeutics has reached a settlement with Hikma Pharmaceuticals regarding the patents for its narcolepsy drug, Sunosi, which allows Hikma to sell a generic version in the U.S. under certain conditions starting in 2040 [1][4]. Group 1: Settlement Agreement - The settlement resolves ongoing patent litigation initiated by Axsome against Hikma for filing an abbreviated new drug application for a generic version of Sunosi [1]. - Axsome will grant Hikma a license to market a generic version of Sunosi in the U.S. after March 1, 2040, or September 1, 2040, if pediatric exclusivity is granted [4]. - The settlement must be reviewed by the U.S. Federal Trade Commission and the U.S. Department of Justice [5]. Group 2: Product and Market Performance - Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals in May 2022 and began selling it in the U.S. market the same month, with international sales starting in November 2022 [2]. - Sunosi generated sales of $94.3 million in 2024, marking a 26% increase year-over-year [6]. - The drug is a significant revenue driver for Axsome and is currently being evaluated in phase III studies for ADHD, major depressive disorder, binge eating disorder, and excessive sleepiness associated with shift work disorder [7]. Group 3: Future Developments - Top-line data from studies evaluating Sunosi for ADHD and major depressive disorder are expected to be released in the first quarter of 2025 [8]. - Ongoing patent litigation related to Sunosi against other parties remains pending in the U.S. District Court for the District of New Jersey [5]. Group 4: Stock Performance - Over the past year, Axsome's shares have increased by 73.6%, contrasting with a 9.1% decline in the industry [3].

NEW YORK, March 05, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) (Axsome), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Hikma Pharmaceuticals USA, Inc. (Hikma) resolving patent litigation related to Axsome’s product Sunosi® (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submis ...

Core Viewpoint - Axsome Therapeutics is progressing towards submitting a supplemental new drug application (sNDA) for AXS-05 as a treatment for agitation in Alzheimer's disease, with expectations to file in Q3 2025 [1][2]. Group 1: Regulatory and Clinical Developments - The FDA has provided formal feedback indicating that Axsome's regulatory data package is sufficient for the sNDA submission for AXS-05 in agitation associated with Alzheimer's disease [1]. - The sNDA will be supported by data from four pivotal late-stage studies demonstrating a statistically significant delay in the time to relapse of agitation in Alzheimer's patients compared to placebo [3]. Group 2: Product Performance and Market Potential - AXS-05 is already approved for treating major depressive disorder (MDD) and has generated $291 million in sales since its launch, reflecting a 124% year-over-year increase [4][7]. - The company is also exploring the expansion of Auvelity's label for other CNS disorders, including smoking cessation, with plans to initiate a pivotal study later this year [8][9]. Group 3: Stock Performance - Shares of Axsome Therapeutics have increased by over 50% in the past year, significantly outperforming the industry growth of 6% [5].

Core Insights - Axsome Therapeutics is preparing to submit a supplemental New Drug Application (sNDA) for AXS-05, aimed at treating agitation in Alzheimer's disease, with submission anticipated in the third quarter of 2025 [1][2][3] Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on developing treatments for central nervous system (CNS) disorders, with a portfolio that includes FDA-approved therapies for major depressive disorder, narcolepsy, and migraine [6] Product Details - AXS-05 is an investigational drug combining dextromethorphan and bupropion, functioning as an NMDA receptor antagonist and sigma-1 agonist, with a unique formulation designed to enhance bioavailability [5] - The drug has received Breakthrough Therapy designation from the FDA for Alzheimer's disease agitation, indicating its potential to address significant unmet medical needs [2][5] Clinical Development - The clinical development program for AXS-05 includes four completed pivotal Phase 3 trials, demonstrating statistically significant improvements in agitation symptoms compared to placebo [3] - AXS-05 has shown a favorable safety profile, with no deaths reported and no increased risk of falls, sedation, or cognitive decline in long-term studies [3] Market Context - Alzheimer's disease affects approximately 7 million people in the U.S., with agitation reported in up to 70% of patients, highlighting a significant market opportunity for effective treatments [4]

Core Viewpoint - Axsome Therapeutics has received positive feedback from the FDA regarding the planned supplemental NDA submission for AXS-05, aimed at treating agitation in Alzheimer's disease, indicating a potential new treatment option for a condition with high unmet medical needs [1][2][3] Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on developing treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for various conditions [7] Product Information - AXS-05 is an investigational drug combining dextromethorphan and bupropion, functioning as an NMDA receptor antagonist and sigma-1 agonist, currently under development for Alzheimer's disease agitation and smoking cessation [5] - The drug has been granted Breakthrough Therapy designation by the FDA, which allows for expedited review processes [2][5] Clinical Development - The clinical development program for AXS-05 includes four completed pivotal Phase 3 trials demonstrating statistically significant improvements in agitation symptoms compared to placebo [3] - AXS-05 has shown long-term safety and tolerability in over 300 patients treated for at least six months, with no deaths reported and no increased risk of falls or cognitive decline [3] Market Context - Alzheimer's disease affects approximately 7 million people in the U.S., with agitation reported in up to 70% of these patients, highlighting a significant market need for effective treatments [4]

Core Viewpoint - Axsome Therapeutics is actively participating in two investor conferences in March 2025, showcasing its commitment to advancing treatments for central nervous system disorders [1][4]. Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system (CNS) conditions, with a portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine [2]. - The company aims to address significant gaps in care by developing differentiated products that lead to meaningful advancements in patient outcomes, impacting over 150 million people in the United States [2]. Upcoming Events - The company will present at the TD Cowen 45th Annual Health Care Conference on March 4, 2025, at 9:50 a.m. ET in Boston, MA [4]. - Additionally, Axsome will present at the Leerink Partners Global Biopharma Conference on March 12, 2025, at 10:40 a.m. ET in Miami, FL [4].

Core Insights - Axsome Therapeutics, Inc. announced that the EMERGE Phase 3 trial of Symbravo met its primary endpoint, showing a statistically significant greater migraine treatment response compared to oral CGRP inhibitors [1][2] Group 1: Trial Results - Symbravo demonstrated a treatment response measured by the Migraine Treatment Optimization Questionnaire (mTOQ-4) with scores of 5.2 versus 2.8 for oral CGRP inhibitors, achieving statistical significance (p<0.001) [1] - The trial indicated that Symbravo rapidly and substantially improved migraine pain and bothersome symptoms [2] Group 2: Patient Outcomes - 47.9% of patients reported pain freedom within 2 hours after treatment with Symbravo, compared to only 1.0% for oral CGRP inhibitors [3] - Sustained relief of migraine pain for at least 24 hours was reported by 47.9% of patients using Symbravo, versus 16.7% for oral CGRP inhibitors [3] - 51.0% of patients were able to quickly return to normal activities after taking Symbravo, compared to 11.5% for oral CGRP inhibitors [3] - 63.5% of patients felt comfortable enough with Symbravo to plan daily activities, compared to 26.0% for oral CGRP inhibitors [3]

Core Insights - SYMBRAVO demonstrated statistically significant improvements in migraine treatment response compared to oral CGRP inhibitors, achieving the primary endpoint in the EMERGE Phase 3 trial [1][3][8] - The trial showed that 47.9% of patients experienced 2-hour pain freedom after SYMBRAVO, compared to only 1.0% after oral CGRPs [1][5] - SYMBRAVO also provided sustained pain relief for 24 hours or more for 47.9% of patients, significantly higher than the 16.7% seen with oral CGRPs [1][5] Company Overview - Axsome Therapeutics, Inc. is a biopharmaceutical company focused on treating central nervous system disorders, with a portfolio that includes FDA-approved treatments for various conditions [34] - The company aims to address critical gaps in care by developing differentiated products with novel mechanisms of action [34] Trial Details - The EMERGE trial was an open-label study involving 96 patients who had inadequate responses to oral CGRP inhibitors, assessing treatment responses using the Migraine Treatment Optimization Questionnaire (mTOQ-4) [2][8] - Patients switched to SYMBRAVO for their next four migraine attacks, with a total of 365 attacks treated during the trial [2] Efficacy Results - The mTOQ-4 total score improved significantly with SYMBRAVO (5.2) compared to oral CGRPs (2.8), indicating better treatment optimization [3][4] - Key metrics showed that 51.0% of patients could quickly return to normal activities after SYMBRAVO, compared to 11.5% after oral CGRPs [1][5] Quality of Life Improvements - SYMBRAVO treatment resulted in significant improvements in overall quality of life and daily functioning, as measured by the Migraine-Specific Quality of Life Questionnaire (MSQ) [4][6] - The trial results suggest that SYMBRAVO may effectively address the complex and heterogeneous nature of migraine [6] Safety Profile - SYMBRAVO was well tolerated, with a safety profile consistent with previous studies; common adverse events included fatigue and nausea [7] - The trial reported that 26.0% of patients experienced overall improvement of migraine 30 minutes post-dose, increasing to 69.2% at 2 hours [7]

Core Insights - The article emphasizes a conservative investment strategy, allocating 90% to stable investments and 10% to growth opportunities to achieve balanced returns [1] Valuation Framework - The base valuation framework projects free cash flows over a 9-year period, starting from a baseline year, applying consistent annual growth rates [1] - Cash flows are discounted using a rate calculated through CAPM, considering time value and risk factors, with terminal value calculated for Year 9 [1] - The model assumes steady growth patterns and discount rates that exceed long-term growth to maintain mathematical validity [1] Pharmaceutical Revenue Model - The pharmaceutical revenue model indicates a linear market adoption from 10% initial uptake to full penetration, followed by an 8% yearly decline while maintaining at least 40% of peak levels [1] - Revenue calculations are based on patient numbers, market penetration, and annual treatment costs, with operating and production costs scaling proportionally with sales volume [1] - The final valuation incorporates success probability factors and time-adjusted cash flows using standard discount rates [1]

Product Development and Clinical Trials - The company has three commercial products targeting major depressive disorder (MDD) and excessive daytime sleepiness (EDS), impacting over 150 million people in the U.S.[19] - AXS-05 has received FDA Breakthrough Therapy designation for Alzheimer's disease agitation and has completed a successful Phase 3 clinical program[22] - AXS-12 has been granted FDA Orphan Drug Designation for narcolepsy, with completed positive Phase 2 and Phase 3 trials[23] - AXS-14 is being developed for fibromyalgia, with in-licensed data from Pfizer showing positive Phase 2 and Phase 3 trial results[24] - The company aims to develop products for CNS disorders with high unmet medical needs, focusing on areas with limited treatment options[28] - The company is conducting four Phase 3 trials for solriamfetol in ADHD, MDD, binge eating disorder, and shift work disorder[25] - AXS-05 received FDA Breakthrough Therapy designation for Alzheimer's disease (AD) agitation in June 2020, with pivotal development status confirmed in August 2020[34] - In December 2024, the company announced successful completion of the Phase 3 clinical program for AXS-05, including four trials evaluating its efficacy and safety in AD agitation[34] - AXS-12 demonstrated a statistically significant reduction of 83% in weekly cataplexy attacks compared to 66% for placebo at Week 5 in the SYMPHONY Phase 3 trial[64] - AXS-12 treatment resulted in a 31.8% mean reduction in the average weekly number of inadvertent naps compared to a 5.3% reduction for placebo at Week 2[59] - AXS-12 significantly improved cognitive function, with 42.9% of patients rating their ability to concentrate as "good" to "very good" compared to 25.0% for placebo[60] - The company plans to proceed to a pivotal Phase 2/3 trial for AXS-05 as an aid to smoking cessation based on positive FDA feedback[50] - AXS-12 received Orphan Drug Designation from the FDA for the treatment of narcolepsy in October 2018[52] - Long-term open-label treatment with AXS-12 resulted in a mean reduction of 7.3 points in ESS scores at 6 months, with 78% of patients achieving EDS improvement[72] - AXS-14 (esreboxetine) is being developed for fibromyalgia, with a positive Phase 3 trial showing statistically significant improvements in pain scores compared to placebo[77] - In the Phase 3 trial of esreboxetine, p-values for pain score improvements were p<0.001 for 4 mg and 8 mg doses, and p=0.025 for the 10 mg dose[77] Intellectual Property and Market Exclusivity - The intellectual property portfolio includes patents extending to 2043 for AXS-05 and 2042 for Sunosi, ensuring long-term market exclusivity[27] - The intellectual property portfolio includes over 600 issued patents and more than 400 pending applications globally, with significant coverage for AXS-05, AXS-07, and AXS-12 extending through 2043, 2040, and 2039 respectively[97] Regulatory and Compliance - The FDA regulates drugs under the FDCA, requiring completion of preclinical studies and submission of an IND before clinical trials can commence[109] - Clinical trials are conducted in three phases: Phase 1 focuses on safety and dosage, Phase 2 evaluates preliminary efficacy, and Phase 3 generates statistically significant evidence for approval[119] - The FDA aims to review 90% of standard NDA applications within ten months from the filing date[127] - The approval process includes inspections of manufacturing facilities and clinical trial sites to ensure compliance with cGMP and GCP[131] - The FDA may issue a Complete Response Letter (CRL) if the NDA does not meet regulatory criteria, detailing specific deficiencies[133] - The Pediatric Research Equity Act requires pediatric data to assess safety and effectiveness for relevant subpopulations in NDA submissions[125] - The company must develop manufacturing processes in compliance with cGMP to ensure drug quality and purity[117] - The FDA may impose conditions on product approval that can materially affect market potential and profitability, including post-approval studies and distribution restrictions[135] - Changes to approved products, such as new indications or manufacturing changes, require further testing and FDA review[136] - Regulatory exclusivity provisions can delay the submission or approval of applications, with five years of exclusivity for New Chemical Entities (NCEs) and three years for certain changes to marketed products[143][144] - The Orphan Drug Act provides seven years of exclusivity for drugs treating rare diseases, along with financial incentives for development[146] - The FDA has expedited review programs, such as Fast Track and Priority Review, to accelerate the approval process for drugs addressing serious conditions[147][150] Financial and Operational Considerations - The company has assumed liabilities and agreed to make non-refundable royalty payments to Jazz Pharmaceuticals based on U.S. net sales, with a commitment to pay up to $165 million based on revenue milestones and $1 million based on development milestones[94] - The company plans to expand its commercial infrastructure in the U.S. to prepare for anticipated drug approvals, with potential co-promotion partnerships to enhance market reach[100] - The commercial success of the company's products depends on adequate coverage and reimbursement from governmental and private payors, which are increasingly limiting prices[179] - Legislative proposals aimed at healthcare reform may result in lower reimbursement rates or exclusion of the company's products from coverage[187] - The company may need to conduct expensive pharmacoeconomic studies to demonstrate the cost-effectiveness of its products[184] - The increased emphasis on managed healthcare and pricing controls in the U.S. and EU may adversely affect future product sales[183] - Research and development expenses were $187.1 million for the year ended December 31, 2024, compared to $97.9 million for 2023, indicating a significant increase[212] - The company expects research and development expenses to stabilize in the near term as certain development programs near completion[212] Employee Relations and Corporate Structure - As of February 11, 2025, the company had 683 full-time employees, with no employees represented by a collective bargaining agreement[215] - The company maintains good relations with employees and offers competitive salaries, bonuses, and a robust employment package[215] - The company is incorporated in Delaware and has its offices located at One World Trade Center, New York[216] - The company files reports with the SEC and makes them available on its website, including annual and quarterly reports[217]