Core Insights - Axsome Therapeutics announced positive results from the FOCUS Phase 3 trial of solriamfetol for treating ADHD, achieving both primary and key secondary endpoints with statistically significant improvements compared to placebo [1][2][3] Group 1: Trial Results - The trial demonstrated a statistically significant reduction in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score, with mean reductions of 17.7 points for solriamfetol 150 mg versus 14.3 points for placebo, representing a 45% mean reduction from baseline in ADHD symptoms [2][3] - Clinical response, defined as a ≥30% improvement from baseline in the AISRS total score, was achieved by 53.5% of patients on solriamfetol 150 mg compared to 41.3% on placebo at Week 6 [2] - The onset of action for solriamfetol was observed as early as Week 1, with a statistically significant improvement compared to placebo [1][2] Group 2: Safety and Tolerability - Solriamfetol was well tolerated, with a safety profile consistent with previous trials, and no serious adverse events reported [1][4] - Rates of adverse events were dose-dependent, indicating a manageable safety profile for the drug [4] Group 3: Future Development - Axsome Therapeutics plans to initiate a trial for solriamfetol in pediatric patients following the positive results in adults, highlighting the company's commitment to expanding treatment options for ADHD [4][6] - The results from the FOCUS trial provide the first evidence from a multicenter controlled trial regarding the efficacy of solriamfetol in treating ADHD, positioning it as a potential new treatment option [4][6] Group 4: Industry Context - ADHD is a prevalent condition affecting an estimated 15.5 million adults and 7 million children in the U.S., with significant societal costs exceeding $120 billion annually [7] - Solriamfetol is being developed as a treatment for ADHD and other CNS disorders, indicating its potential impact on a large patient population [8][9]

Axsome Therapeutics’ (AXSM) Auvelity (AXS-05) was launched in the United States in 2022 for the treatment of major depressive disorder (MDD), making it the first approved drug in the company’s portfolio.Auvelity generated sales worth $291.4 million in 2024, reflecting an increase of 124% year over year in the United States. Sales of the drug are being driven by an increase in unit sales volume and the momentum is likely to continue in 2025.Axsome is also working to expand the label of Auvelity for the large ...

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]