Reviva Pharmaceuticals

Reviva Pharmaceuticals will present topline data from the 52-week open-label extension portion of their Phase 3 RECOVER study evaluating brilaroxazine in schizophrenia at the 2025 SIRS Congress in Chicago.

Roth MKM initiated coverage of Reviva Pharmaceuticals with a Buy rating, citing positive Phase 3 data for brilaroxazine in treating schizophrenia.

• Xanomeline/trospium chloride (Cobenfy) improved cognition in schizophrenia patients with baseline cognitive impairment, according to an exploratory analysis of two phase III trials. • MindMed initiated a phase III trial of lysergide D-tartrate (LSD) for generalized anxiety disorder, marking the first phase III trial for LSD. • Reviva Pharmaceuticals reported that brilaroxazine significantly reduced PANSS total score in schizophrenia patients after 52 weeks in a long-term extension study. • A recall of over 230,000 bottles of duloxetine (Cymbalta) was initiated due to the potential presence of a carcinogen.

Reviva Pharmaceuticals' brilaroxazine demonstrated sustained efficacy and a favorable safety profile over one year in patients with schizophrenia in the Phase 3 RECOVER study's open-label extension (OLE).

• AbbVie's emraclidine failed to demonstrate statistically significant improvement in schizophrenia symptoms in Phase II trials, a setback for the muscarinic pathway approach. • Bristol Myers Squibb's Cobenfy (KarXT), a muscarinic agonist, now stands as the frontrunner in schizophrenia treatment after AbbVie's trial failures. • Neurocrine Biosciences is advancing NBI-1117568, an oral muscarinic M4 selective agonist, with Phase III trials planned for early 2025, showing a potential path forward. • Other companies like Neumora Therapeutics and Reviva Pharmaceuticals are also exploring novel mechanisms for schizophrenia treatment, indicating a dynamic therapeutic landscape.

Reviva Pharmaceuticals announced positive speech latency data for brilaroxazine in schizophrenia from the Phase 3 RECOVER trial.

Reviva Pharmaceuticals announced positive speech latency data for brilaroxazine in schizophrenia from the Phase 3 RECOVER trial.

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

Over 22 pharmaceutical and biotech companies are actively developing more than 22 pipeline drugs for bipolar disorder, addressing a significant unmet need.

• The schizophrenia treatment landscape is expanding with over 60 drugs in active development, driven by increased R&D and innovative therapies. • Key players like Sumitomo Pharma, Boehringer Ingelheim, and Reviva Pharmaceuticals are advancing novel antipsychotics and personalized medicine approaches. • Recent progress includes positive Phase III trial results for brilaroxazine and LY03020's IND approval in China, signaling potential new treatment options. • COBENFY, a first-in-class muscarinic agonist, received FDA approval, marking a significant advancement in schizophrenia treatment after 35 years.