Late-breaking oral presentation of results from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation Presentation featuring network meta-analysis of SYMBRAVO® versus oral CGRPs NEW YORK, April 04, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced multiple presentations spanning its innovative, industry-leading psychiatry and neurology po ...

Core Insights - Axsome Therapeutics is presenting results from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 for Alzheimer's disease agitation at the 2025 AAN Annual Meeting [1][2] - The company is also showcasing data from the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy and a network meta-analysis comparing SYMBRAVO® to oral CGRPs for migraine treatment [2] Alzheimer's Disease Agitation - Title of the presentation: "Efficacy and Safety of AXS-05 in Alzheimer's Disease Agitation: A Phase 3 Randomized Withdrawal Double-Blind Placebo-Controlled Study" [3] - Oral presentation scheduled for April 7, 11:27 - 11:33 a.m. PT, with a poster presentation following from 12:09 - 12:45 p.m. PT [3] Narcolepsy - Title of the presentation: "AXS-12 for the Treatment of Narcolepsy: Topline Results from the Phase 3 SYMPHONY Trial" [3] - Oral presentation scheduled for April 8, 10:45 - 11 a.m. PT [3] - Additional poster presentation titled "CRESCENDO: Results from a Survey of Symptom Burden and Quality of Life in Patients with Narcolepsy Type 1" on April 8, 8 - 9 a.m. PT [3] Migraine - Title of the presentation: "Comparative Efficacy of AXS-07 vs. Gepants for Acute Treatment of Migraine: A Network Meta-Analysis" [4] - Poster presentation scheduled for April 8, 5 - 6 p.m. PT [4] - SYMBRAVO is a novel oral medication approved for acute migraine treatment, combining MoSEIC™ meloxicam and rizatriptan [5][6] Company Overview - Axsome Therapeutics focuses on innovative treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for major depressive disorder, narcolepsy, and migraine [35] - The company aims to address significant gaps in care and improve patient outcomes through novel mechanisms of action [35]

Axsome Therapeutics (AXSM) announced top-line data from the phase III PARADIGM study, which evaluated solriamfetol for the treatment of major depressive disorder (MDD) with and without severe excessive daytime sleepiness (EDS).Axsome currently markets solriamfetol as Sunosi for treating narcolepsy.Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals (JAZZ) in May 2022. It began selling Sunosi in the U.S. market in May 2022 and in certain international markets in November 2022.Jazz had received ap ...

The details: Shares of biopharmaceutical company Axsome Therapeutics (AXSM -5.80%) had declined 6% at 11 a.m. ET today. The slump comes after the company announced the results of a phase 3 trial of solriamfetol (brand name Sunosi) in major depressive disorder (MDD). What the results mean The trial was somewhat complicated, so bear with me. It was a six-week proof-of-concept phase 3 trial for MDD "with and without severe excess daytime sleepiness (EDS)." The primary aim of the trial was to demonstrate signif ...

Results support continued development in MDD with concomitant EDS; Phase 3 trial planned in 2025 Approximately 50 percent of MDD patients experience EDS1, highlighting high unmet need NEW YORK, April 01, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced results of the PARADIGM Phase 3 proof-of-concept trial of solriamfetol in major depressive disorder (MDD) with and witho ...

Axsome Therapeutics (AXSM) announced that the phase III FOCUS study, which evaluated solriamfetol for the treatment of attention deficit hyperactivity disorder (ADHD), has met its primary and key secondary endpoints.Axsome currently markets solriamfetol as Sunosi for treating narcolepsy.Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals (JAZZ) in May 2022. It began selling Sunosi in the U.S. market in May 2022 and in certain international markets in November 2022.Jazz had received approval for ...

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 ...