Core Viewpoint - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by certain officers and directors of Axsome Therapeutics, Inc. related to misrepresentation of the company's practices and prospects [1] Group 1: Allegations of Misrepresentation - Insiders at Axsome allegedly caused the company to misrepresent or fail to disclose deficiencies in its chemistry, manufacturing, and control (CMC) practices concerning AXS-07 [2] - As a result of these deficiencies, Axsome was unlikely to submit the AXS-07 New Drug Application (NDA) on the initially represented timeline [2] - The unresolved CMC issues were present during the FDA's review of the AXS-07 NDA, leading to a low likelihood of FDA approval [2] - Consequently, Axsome overstated AXS-07's regulatory and commercial prospects, making the company's public statements materially false and misleading [2]

Core Viewpoint - Axsome Therapeutics, Inc. is set to report its financial results for Q1 2025 on May 5, 2025, and will host a conference call to discuss these results and provide a business update [1] Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system (CNS) disorders, with a portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine [3] - The company aims to address significant gaps in care by developing differentiated products with novel mechanisms of action, impacting over 150 million people in the United States [3] Conference Call Details - The conference call will take place at 8:00 a.m. Eastern Time on May 5, 2025, following the financial results announcement [1] - Participants can join the call by dialing (877) 405-1239 for domestic calls or +1 (201) 389-0851 for international calls, with a live webcast available on the company's website [2]

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]

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, 2025, from 11:27 to 11:33 a.m. PT [3] - Poster presentation on the same day from 12:09 to 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, 2025, from 10:45 to 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, 2025, from 8 to 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, 2025, from 5 to 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 developing innovative treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for major depressive disorder, narcolepsy, and migraine [34][35] - AXS-05 is an investigational drug for Alzheimer's disease agitation and smoking cessation, utilizing a proprietary formulation of dextromethorphan and bupropion [32] - AXS-12 is under development for narcolepsy and has received FDA Orphan Drug Designation [33]

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 ...

Core Viewpoint - Axsome Therapeutics' shares declined by 6% following the announcement of phase 3 trial results for solriamfetol in major depressive disorder (MDD) [1] Group 1: Trial Results - The phase 3 trial was a six-week proof-of-concept study for MDD, assessing patients with and without severe excess daytime sleepiness (EDS) [2] - The primary aim was to show significant improvement in the overall population, which included 51 patients with severe EDS and 295 without [2] - The trial did not demonstrate a statistical improvement in the overall population when comparing solriamfetol to placebo [5] Group 2: Implications for Patients - In MDD patients with severe EDS, solriamfetol showed clinically meaningful improvements compared to placebo on multiple efficacy measures, including the Montgomery-Asberg Depression Rating Scale (MADRS) [5] - The positive response in severe EDS cases has encouraged the company to plan a subsequent phase 3 trial in 2025 [3] Group 3: Investor Outlook - The mixed results from the trial led to a decline in stock value, as the primary aim was not met [4] - If the positive results in severe EDS cases are replicated in future trials, the company could claim success; however, approval limited to severe EDS would likely result in lower sales compared to broader approval for all EDS patients [4]

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]