17 abstracts from across the Company's portfolio and pipeline highlight new clinical and real-world data on major depressive disorder and treatment-resistant depression New post-hoc analysis of CAPLYTA (lumateperone) Phase 3 data evaluates the impact on sexual function in MDD, reinforcing potential to reset treatment expectations European Union and United Kingdom sub-group analyses of Phase 3 data evaluate efficacy of adjunctive seltorexant compared to adjunctive quetiapine XR in MDD with insomnia symptoms ...

Core Insights - Johnson & Johnson is presenting 21 abstracts at the U.S. Psychiatric and Mental Health Congress, focusing on major depressive disorder, treatment-resistant depression, and schizophrenia [1][4] - The company emphasizes its commitment to advancing neuroscience and improving patient outcomes through innovative treatments [2][4] Group 1: Major Depressive Disorder (MDD) - MDD affects approximately 332 million people globally, representing about 5% of the population, with around 21 million adults in the U.S. experiencing at least one major depressive episode in 2021 [7][8] - Current treatments often fail to address the unique symptoms of MDD, with 2 in 3 patients continuing to experience residual symptoms despite standard care [7][8] - Insomnia is a common symptom in MDD, affecting about 60% of patients, which can worsen the quality of life and increase the risk of relapse [8] Group 2: Treatment-Resistant Depression (TRD) - Approximately one-third of adults with MDD are classified as having TRD, defined as inadequate response to two or more oral antidepressants [9][10] - The economic burden of TRD is significant, with many patients cycling through multiple medications without achieving remission [10] - The STAR*d study indicates that after trying a third oral antidepressant, about 86% of patients do not achieve remission [10] Group 3: Innovative Treatments - Seltorexant is an investigational therapy being studied as an adjunctive treatment for MDD with insomnia symptoms, aiming to normalize orexin-2 receptor overactivation [13] - CAPLYTA (lumateperone) is approved for treating schizophrenia and bipolar depression, with a supplemental new drug application under review for its use in MDD [11][12] - SPRAVATO (esketamine) is approved for TRD and MDD with suicidal ideation, having been administered to over 150,000 patients worldwide [12][13] Group 4: Schizophrenia Portfolio - Johnson & Johnson offers a comprehensive portfolio of schizophrenia therapies, including long-acting injectables like INVEGA SUSTENNA, INVEGA TRINZA, and INVEGA HAFYERA [14][36] - These treatments provide various dosing options and are designed to support individual patient needs [14][36]

Axsome Therapeutics (AXSM) Conference Call Summary Company Overview - Axsome Therapeutics is a commercial-stage company focused on Central Nervous System (CNS) indications with several approved products and a broad pipeline [1][2] Key Financial Performance - Q1 2025 net sales reached $120 million, with $96 million from OVALITY (for major depressive disorder) and $25 million from Sunosi [4][5] Product Launches and Pipeline - Symbravo, for acute treatment of migraine, is set to launch next month [5][6] - AXS-05 for Alzheimer's disease agitation is on track for an sNDA submission in Q3 2025 [6][18] - Positive data readouts for solriamfetol in ADHD and major depressive disorder with excessive daytime sleepiness [7][39] Market Adoption and Sales Strategy - OVALITY has over 50% adoption as a first or second-line treatment in major depressive disorder [9] - The sales team has expanded to approximately 300 account managers, with expectations for growth in the commercial channel [10][11] - The company aims for over 80-85% of lives covered in the antidepressant class [11][12] Competitive Advantages - OVALITY is noted for its rapid onset of action, durability, and favorable safety profile compared to traditional antidepressants [14][15] - AXS-05 is differentiated from atypical antipsychotics, which have a black box warning for elderly patients with dementia [23][24] Clinical Development Highlights - Three positive trials completed for AXS-05 in Alzheimer's agitation, with no safety signals for falls or mortality [17][18] - The company is preparing for NDA submissions for AXS-14 (fibromyalgia) and AXS-12 (cataplexy in narcolepsy) [45][46] Future Outlook - Axsome anticipates significant growth and attention as more products come into focus, particularly with ongoing regulatory filings and launches [47][48]