Core Insights - Johnson & Johnson announced the FDA approval of CAPLYTA (lumateperone) as an adjunctive therapy for major depressive disorder (MDD) in adults, marking a significant addition to treatment options for patients experiencing residual symptoms despite current antidepressant therapies [1][2][8] Summary by Sections Approval and Indications - CAPLYTA is now approved for use alongside antidepressants for MDD, as well as for bipolar I and II depression and schizophrenia, making it the first FDA-approved treatment for bipolar depression in adults [1][15] - This approval follows Johnson & Johnson's acquisition of Intra-Cellular Therapies, Inc., and represents the fourth indication for CAPLYTA [1][8] Clinical Efficacy - The approval is based on positive results from two Phase 3 trials (Study 501 and 502), which demonstrated significant improvements in depression symptoms compared to placebo [2][12] - In Study 501, the mean change in Montgomery-Asberg Depression Rating Scale (MADRS) score was -4.9 points (effect size 0.61), while Study 502 showed a -4.5 points change (effect size 0.56) at six weeks [3][12] - Early separation from placebo was observed as soon as one week in Study 501 and two weeks in Study 502 [3] Safety and Tolerability - CAPLYTA's safety profile was consistent with previous studies, showing no new safety concerns, and weight gain and metabolic changes were similar to placebo [4][6] - The most common side effects included sleepiness, dizziness, nausea, dry mouth, fatigue, and diarrhea [4][22] - In a 26-week open-label extension study (Study 503), 80% of patients responded to treatment, and 65% achieved remission, defined as a MADRS total score of 10 or less [6][13] Mechanism of Action - While the exact mechanism of action is not fully understood, CAPLYTA is characterized by high serotonin 5-HT2A receptor occupancy and moderate dopamine D2 receptor occupancy at therapeutic doses [7][16] Market Context - MDD affects approximately 22 million adults in the U.S., with 2 in 3 patients experiencing residual symptoms despite treatment, highlighting the need for effective adjunctive therapies [1][11] - The introduction of CAPLYTA is expected to reset treatment expectations and provide hope for patients seeking remission from depression [5][8]

Core Insights - Johnson & Johnson presented 17 abstracts at the European College of Neuropsychopharmacology (ECNP) Congress, showcasing new clinical and real-world data on major depressive disorder (MDD) and treatment-resistant depression (TRD) [1][2]. Group 1: Major Depressive Disorder (MDD) - MDD affects approximately 332 million people globally, representing about 4% of the population, with around 22 million adults in the U.S. experiencing at least one major depressive episode in 2023 [8]. - The disorder is complex and heterogeneous, with up to 256 unique symptom combinations, leading to varied treatment responses [8]. - Current standard-of-care oral antidepressants leave 2 in 3 patients with residual symptoms, highlighting the need for innovative treatment approaches [8]. Group 2: Treatment-Resistant Depression (TRD) - About one-third of adults with MDD do not respond to oral antidepressants and are classified as having TRD, which significantly impacts their quality of life and has a high economic burden [11]. - The STAR*D study indicates that approximately 86% of patients do not achieve remission after trying their third oral antidepressant [11]. Group 3: New Treatment Data - New analyses from Phase 3 data evaluate the impact of CAPLYTA (lumateperone) on sexual function in MDD patients, suggesting a potential to reset treatment expectations [6]. - A sub-group analysis of Phase 3 data compares the efficacy of adjunctive seltorexant with quetiapine XR in MDD patients with insomnia symptoms [6]. - Findings from the ESCAPE-TRD study explore the association between patient characteristics and remission with SPRAVATO (esketamine) versus quetiapine XR in TRD patients [6]. Group 4: Company Commitment - Johnson & Johnson emphasizes a patient-first approach in developing innovative therapies for MDD and TRD, as stated by the Global Neuroscience Therapeutic Area Head [2].

Core Insights - Nuvectis Pharma, Inc. has appointed Dr. Juan Sanchez to its Board of Directors, bringing extensive experience in biotech and capital markets [1][3] - Dr. Sanchez previously served as Vice President of Corporate Communications and Investor Relations at Intra-Cellular Therapies, which was acquired by Johnson & Johnson for $14.6 billion in April 2025 [2][3] - The company is entering a new growth phase with the initiation of the Phase 1b program for its lead drug candidate, NXP900, aimed at treating advanced and treatment-resistant cancers [3][4] Company Overview - Nuvectis Pharma focuses on developing innovative precision medicines for serious unmet medical needs in oncology [4] - The lead program, NXP900, is an oral small molecule inhibitor targeting SRC Family of Kinases (SFK), having completed a Phase 1a dose escalation study and currently being evaluated in a Phase 1b program [4] - The company is also exploring next steps for NXP800, which has shown anti-cancer activity in specific ovarian cancer cases [4] Dr. Juan Sanchez's Background - Dr. Sanchez has over 30 years of experience in healthcare, combining roles in patient care, research analysis, and executive leadership in biopharmaceuticals [3] - His tenure at Intra-Cellular Therapies included the successful development and commercialization of CAPLYTA (lumateperone) [3] - Dr. Sanchez holds advanced degrees in International Affairs, Business Administration, and Medicine, and has practiced medicine for five years in Colombia [3]