Schizophrenia treatment

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Bristol Myers Squibb and TV Host Gail Simmons Tackle Stigma in Schizophrenia with New Initiative Spotlighting the Power of Support and Connection
Businesswire· 2025-10-10 10:45
The initiative features the perspectives of adults living with schizophrenia and taking COBENFYâ"¢ (xanomeline and trospium chloride), their care partners and a psychiatrist PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced the launch of its COBENFY Connectionsâ"¢ initiative in partnership with culinary expert, TV host and author Gail Simmons.* Launching on World Mental Health Day, the initiative features real stories from people affected by schizophrenia, including Simmons, ...
Can BMYs Neuroscience Portfolio Help to Diversify Its Business?
ZACKS· 2025-10-08 16:01
Core Insights - Bristol Myers (BMY) is focusing on expanding its pipeline due to the negative impact of generics on its legacy portfolio, particularly Revlimid, Pomalyst, Sprycel, and Abraxane [1] - The FDA has granted Fast Track Designation to BMS-986446, an anti-MTBR-tau antibody in phase II development for early Alzheimer's disease [1][10] - BMY's neuroscience portfolio has been enhanced by the FDA approval of xanomeline and trospium chloride (Cobenfy) for schizophrenia, with initial sales of $62 million in the first half of 2025 [2][3] Neuroscience Pipeline - Cobenfy is undergoing registrational trials for Alzheimer's disease, including studies on psychosis, agitation, and cognitive impairment, and is also in a phase III study for bipolar 1 disorder [4] - The drug is expected to be a significant growth driver for BMY as it seeks label expansions into new indications [4] - BMY's neuroscience pipeline includes candidates for neurodegenerative diseases (BMS-986495) and treatments for multiple sclerosis, mood, and anxiety disorders [5] Competitive Landscape - BMY's Alzheimer's candidates will face competition from existing products like Eli Lilly's Kisunla and Biogen and Eisai's Leqembi upon potential approval [6] - Eli Lilly's Kisunla was approved for early symptomatic Alzheimer's disease, and ongoing trials are evaluating its efficacy in preclinical stages [7][8] Financial Performance - BMY's shares have declined by 17.1% year-to-date, contrasting with the industry's growth of 10.4% [9] - The company is trading at a price/earnings ratio of 7.24X forward earnings, below its historical mean of 8.45X and the large-cap pharma industry's average of 15.87X [11] - The bottom-line estimate for 2025 has increased to $6.51 from $6.46, while the estimate for 2026 has decreased to $6.06 from $6.07 [13]
LB Pharmaceuticals to Present Three Posters at 38th ECNP Congress Highlighting Clinical Activity and Safety Profile of LB-102 in Schizophrenia, Including Positive Effects on Cognition and Negative Symptoms
Globenewswire· 2025-10-06 12:30
NEW YORK, Oct. 06, 2025 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX) today announced that three posters featuring new and previously reported analyses from its Phase 2 NOVA1 clinical trial of LB-102 in acute schizophrenia will be presented at the 38th European College of Neuropsychopharmacology (“ECNP”) Congress, taking place in Amsterdam, The Netherlands, from October 11-14, 2025. Among the presentations will be an analysis evaluating the effects of LB-1 ...
Anavex Life Sciences Announces Positive Topline Results from Phase 2 Study of ANAVEX®3-71 for the Treatment of Schizophrenia
Globenewswire· 2025-10-02 11:30
ANAVEX3-71-SZ-001 achieved its primary endpoint demonstrating safety and tolerability in adults with schizophrenia Encouraging trends observed in biomarkers support continued development NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, today announced positive topline res ...
Teva Pharmaceutical Industries Limited - Special Call
Seeking Alpha· 2025-09-22 18:53
Core Points - The conference call is focused on the presentation of Phase III SOLARIS data for Olanzapine LAI TEV-'749, which is related to schizophrenia treatment [1][4] - The call includes forward-looking statements, and the company does not commit to updating these statements post-call [2] Company Overview - Teva has a strong neuroscience legacy, which is emphasized by the Executive VP of Global R&D and Chief Medical Officer during the call [4]
Bristol Myers plans to launch schizophrenia drug in UK at list price equal to the US
Reuters· 2025-09-22 11:26
Core Viewpoint - Bristol Myers Squibb plans to launch its schizophrenia treatment Cobenfy in the UK in 2026 at a price equal to its US list price [1] Company Summary - The company is preparing for the introduction of Cobenfy, targeting the UK market for schizophrenia treatment [1] Industry Summary - The launch of Cobenfy in the UK represents a strategic move within the pharmaceutical industry, particularly in the mental health treatment sector [1]
New Long-term Safety Data from the Completed Phase 3 SOLARIS Trial Support the Potential of Olanzapine LAI (TEV-'749) as the First Long-Acting Olanzapine Treatment Option for Schizophrenia with No PDSS Observed
Globenewswire· 2025-09-21 02:15
Core Insights - Teva Pharmaceuticals presented new data on its schizophrenia treatment portfolio, including long-term safety results from the SOLARIS Phase 3 trial for olanzapine LAI (TEV-'749), which showed no incidence of post-injection delirium/sedation syndrome (PDSS) [1][4] - The data also highlighted UZEDY, an extended-release injectable suspension of risperidone, which was associated with shorter hospitalization compared to Invega Sustenna, although no direct comparisons on efficacy or safety were made [1][9] Olanzapine LAI (TEV-'749) Data - The SOLARIS trial involved 675 participants aged 18-64, with a randomized double-blind placebo-controlled period followed by an open-label safety period [3][17] - No PDSS events were reported across 3,470 total injections, indicating a favorable safety profile consistent with other olanzapine formulations [4][5] - Long-term effectiveness data showed significant symptom improvement, with a mean change of -7.2 in PANSS total scores and a 4.6-point increase in PSP scores from baseline [7][8] UZEDY Data - A retrospective study indicated that UZEDY led to a 2.89-day shorter length of hospital stay compared to Invega Sustenna, translating to estimated direct cost savings of $3,200 per hospitalization [9] - UZEDY was preferred by healthcare professionals for its ease of administration and dosing characteristics, with 45% favoring it over Invega Sustenna [9][10] Company Commitment - Teva is dedicated to developing innovative treatments for complex neurological conditions, aiming to address unmet needs in mental health care [5][14] - The company plans to submit a New Drug Application (NDA) for olanzapine LAI (TEV-'749) in the second half of 2025 [13][15]
Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo
Prnewswire· 2025-07-08 12:00
Core Insights - Johnson & Johnson submitted a supplemental New Drug Application (sNDA) to the FDA for CAPLYTA® based on long-term Phase 3 data showing a 63% reduction in relapse risk for schizophrenia patients compared to placebo [1][2] - CAPLYTA® is the first and only FDA-approved treatment for both schizophrenia and bipolar I and II depression, enhancing Johnson & Johnson's portfolio of schizophrenia therapies [1][3] Company Overview - Johnson & Johnson's CAPLYTA® is now part of the broadest range of treatment options for adults with schizophrenia, including both oral and long-acting injectable therapies [1] - The company emphasizes its commitment to ongoing research and development to support the long-term use of CAPLYTA® in neuropsychiatric disorders [2] Industry Context - Schizophrenia affects an estimated 2.8 million adults in the U.S., with around 40% of individuals not receiving adequate treatment [2][6] - Relapses in schizophrenia can lead to significant functional decline and increased caregiver burden, highlighting the importance of effective relapse prevention strategies [2][6] - The Phase 3 trial results indicate that CAPLYTA® could play a critical role in managing schizophrenia and preventing relapses, which is essential for patient stability and reducing hospitalization rates [2][7]
Reviva Pharmaceuticals Holdings (RVPH) Update / Briefing Transcript
2025-06-02 13:00
Reviva Pharmaceuticals Holdings (RVPH) Update Summary Company Overview - Reviva Pharmaceuticals is a late-stage pharmaceutical company focused on developing next-generation therapies for central nervous system, respiratory, and metabolic diseases using chemical genomics-driven technologies [3][2]. Key Points from the Call Clinical Trials and Drug Development - Reviva is presenting results from the Phase 3 RECOVER trial, which focuses on the long-term safety, tolerability, and efficacy of viloroxazine in treating schizophrenia [11][12]. - The RECOVER trial included nearly 1,000 patients across multiple studies, demonstrating a differentiated clinical profile for viloroxazine [11]. - The drug showed strong efficacy in both acute and stable schizophrenia, with over 50% better adherence outcomes compared to historical data [12][11]. Efficacy Results - The efficacy of viloroxazine was highlighted, showing significant improvements in both positive and negative symptoms of schizophrenia, with effect sizes for PANSS total and positive symptoms being notably large [20][22]. - The drug demonstrated sustained decreases in psychopathology over a one-year period, with substantial improvements in negative symptoms and social cognition [27][30][33]. - The open-label extension trial indicated that patients experienced a 46.1% decrease in symptoms for the 15 mg dose and a 49.6% decrease for the 50 mg dose over the trial period [28]. Safety and Tolerability - The discontinuation rate due to adverse effects was low at 16% for viloroxazine compared to 22% for placebo, indicating good tolerability [20][44]. - Common side effects included somnolence and headache, with no significant extrapyramidal symptoms reported [45][69]. - The drug showed a weight gain of only 1.2 kg over 13 months, indicating a weight-neutral effect, which is a significant improvement over other atypical antipsychotics [52][70]. Metabolic Profile - Viloroxazine demonstrated reductions in cholesterol and LDL levels, suggesting a favorable metabolic profile compared to existing treatments [53][70]. - The drug also showed a significant reduction in prolactin levels, which is often elevated in patients taking other antipsychotics, potentially improving sexual function [57][71]. Neuroinflammation and Biomarkers - The drug's effects on neuroinflammatory markers were noted, with significant reductions in interleukins and TNF-alpha, suggesting a broad anti-inflammatory effect that may contribute to its efficacy in treating schizophrenia [63][65]. - Improvements in brain-derived neurotrophic factor (BDNF) levels were also reported, which is associated with better neuronal signaling and recovery from damage [64]. Additional Insights - The call emphasized the importance of addressing both positive and negative symptoms in schizophrenia treatment, with viloroxazine showing robust efficacy in both areas [74][76]. - The potential for viloroxazine to improve quality of life and functioning in patients with schizophrenia was highlighted, with suggestions that it could be effective in both acute and chronic settings [35][36]. Conclusion - Reviva Pharmaceuticals is advancing its clinical development of viloroxazine, which shows promise as a treatment for schizophrenia with a favorable safety and efficacy profile compared to existing therapies. The drug's ability to address both positive and negative symptoms, along with its favorable metabolic effects, positions it as a potential next-generation antipsychotic [35][71].
Reviva Pharmaceuticals Holdings (RVPH) Earnings Call Presentation
2025-06-02 12:12
Efficacy of Brilaroxazine - Brilaroxazine demonstrated a significant decrease of 18 points in PANSS total score at Week 52 compared to baseline (p ≤ 0.0001) [41] - There was a 5-point decrease in PANSS positive symptoms score at 12 months with brilaroxazine pooled (15, 30 & 50 mg) vs baseline (p ≤ 0.001) [47] - Brilaroxazine showed a 4.4-point decrease in PANSS negative symptoms score at 12 months compared to baseline (p ≤ 0.001) [50] - 58.5% of patients showed >1-point improvement on the CGI-S scale at 12 months with brilaroxazine pooled (15, 30, & 50 mg) vs baseline (p ≤ 0.001) [69] Safety and Tolerability of Brilaroxazine - In the 52-week open-label trial, 37.2% of patients experienced any treatment emergent adverse event (TEAE) [84] - The pooled brilaroxazine dose group reported a mild weight gain of 1.52 kg [104] - There was a decrease in cholesterol of -8.3 mg/dL overall (p=0.030) and LDL cholesterol of -8.0 mg/dL overall (p=0.0093) in the 12-month OLE trial [90] - A clinically significant decrease in serum prolactin levels of -12.50 ug/L overall was observed from baseline to week-52/EOT [94] - There was an improvement in thyroid (T3) hormone levels of 0.044 ug/L overall (P ≤ 0.05) [97] Trial Design and Demographics - The RECOVER open-label extension (OLE) trial enrolled 446 patients with stable schizophrenia [37]