Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti™ for the Treatments of Acute Bipolar I Disorder and Schizophrenia

Core Insights - Vanda Pharmaceuticals Inc. has submitted a New Drug Application (NDA) to the FDA for Bysanti™ (milsaperidone) aimed at treating acute bipolar I disorder and schizophrenia, supported by multiple clinical studies [1][3] - Bysanti™ is classified as an atypical antipsychotic and is believed to work by interacting with various neurotransmitter receptors in the brain [2] - If approved, Bysanti™ could be available in the US by 2026, with potential patent exclusivity extending into the 2040s [3] Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on developing innovative therapies to meet high unmet medical needs [4]