Reviva Pharmaceuticals

Applied Therapeutics announces leadership changes: John H. Johnson named Executive Chairman, Shoshana Shendelman steps down as CEO, and Les Funtleyder appointed Interim CEO. Business updates include evaluating response to FDA Complete Response Letter for govorestat, withdrawal of MAA to EMA, and ongoing SORD Deficiency clinical program. Inducement awards approved for Johnson.

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.

DelveInsight's 'Bipolar Disorder (Manic Depression) Pipeline Insight, 2024' report details 22+ pipeline drugs from 22+ companies, segmented by RoA, MoA, and molecule types, with therapies in various clinical stages, including late-stage candidates like Vanda Pharmaceuticals' Iloperidone.

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.

Bristol Myers Squibb receives FDA approval for Cobenfy, a new antipsychotic drug for schizophrenia, the first in decades. Cobenfy, also known as KarXT, lacks warnings about increased mortality in elderly patients and common side effects like weight gain and movement disorders. Bristol Myers expects $2.5 billion in U.S. sales by 2030 and plans to launch the drug at $1,850 a month. The approval is based on studies showing significant symptom reduction, targeting cholinergic receptors instead of dopamine. Cobenfy's side effects include vomiting and nausea, and it is not recommended for patients with urinary retention or severe kidney/liver disease.

The U.S. FDA approved Bristol Myers Squibb's schizophrenia drug, Cobenfy (KarXT), which reduces symptoms without common side effects, acquired through the $14 billion takeover of Karuna Therapeutics. Expected to generate $2.5 billion in U.S. sales by 2030, it targets cholinergic receptors, unlike traditional dopamine-targeting antipsychotics. Bristol plans to launch the drug in late October at $1,850 per month, with 80% of patients covered by Medicare and Medicaid.