Brilaroxazine

Reviva Pharmaceutical Holdings reported favorable long-term safety and efficacy results for brilaroxazine in its Phase III RECOVER trial's open label extension. The schizophrenia candidate showed low discontinuation rates and positive PANSS score improvements. Reviva plans to launch RECOVER-2 in 1Q:25, aiming for FDA approval with two positive Phase III studies. The company raised $18 million to fund RECOVER-2 and operations.

Over 230,000 bottles of duloxetine recalled due to potential carcinogen. Xanomeline/trospium chloride improved cognition in schizophrenia patients. One in three Americans ages 50-80 reported loneliness or social isolation. Black and Asian patients with depressive symptoms had lower odds of receiving initial care. Higher daily step count associated with fewer depressive symptoms. Schizophrenia and major depressive disorder may increase constipation risk. San Francisco plans to add 175 more psychiatric beds. Olanzapine/samidorphan maintained symptom control in schizophrenia patients for up to 4 years. American Academy of Pediatrics published report on pediatric acute-onset neuropsychiatric syndrome. First-time ADHD diagnoses rising among people ages 30 and older. Transcutaneous auricular vagus nerve stimulation improved chronic insomnia disorder severity. First phase III trial of LSD underway for generalized anxiety disorder. New recommendations to reduce postoperative delirium and cognitive issues in older patients. Once-daily brilaroxazine decreased PANSS total score in schizophrenia patients. Autism advocates losing faith in FDA banning electric shock devices.

Reviva Pharmaceuticals announced preliminary Phase 3 RECOVER study data showing brilaroxazine's favorable long-term safety, robust efficacy, and low adverse event rates in schizophrenia patients. All three doses (15mg, 30mg, 50mg) were efficacious and well-tolerated. Full data set expected Q1 2025.

Bristol Myers Squibb's Cobenfy, approved by the FDA in September, marked a significant breakthrough in schizophrenia treatment, while AbbVie's muscarinic candidate emraclidine failed mid-stage trials, positioning BMS as the clear winner. Cobenfy's efficacy in three registrational trials contrasts with emraclidine's failure to show significant symptom improvement in Phase II trials, leading to a 12% drop in AbbVie's stock. BMS's acquisition of Karuna Therapeutics for $14 billion in December 2023 further solidified its lead in the schizophrenia market.

Reviva Pharmaceuticals to present positive speech latency data for brilaroxazine in schizophrenia at CNS Summit 2024 on Nov 12th.

Reviva Pharmaceuticals to present positive speech latency data for brilaroxazine in schizophrenia at CNS Summit 2024, poster board 10, Nov 12, 5-7 PM ET, presented by Dr. Jan Sedway.

Reviva Pharmaceuticals to present positive speech latency data for brilaroxazine in schizophrenia from the Phase 3 RECOVER trial at the CNS Summit 2024.

Schizophrenia clinical trial pipeline features 55+ companies and 60+ drugs, with key players like Sumitomo Pharma America, Boehringer Ingelheim, and Reviva Pharmaceuticals advancing novel therapies. Recent milestones include Reviva's Phase III RECOVER trial data, Luye Pharma Group's IND approval for LY03020, and Teva's positive SOLARIS trial results. DelveInsight's report provides comprehensive global coverage and insights into the schizophrenia pipeline.

FDA approved Bristol Myers Squibb's Cobenfy for schizophrenia, while Reviva's Brilaroxazine targets broader receptors, potentially offering cognitive benefits and a better metabolic profile. Both drugs address positive and negative symptoms of schizophrenia.

Reviva Pharmaceuticals reported positive Phase 3 data for its schizophrenia treatment, Brilaroxazine, and plans to file an NDA in Q1 2026. EF Hutton initiated coverage with a Buy rating and a $15 price target.