Vanda Pharmaceuticals’ Stock Soars on FDA Approval of Bysanti
Vanda Pharmaceuticals witnessed a dramatic surge in its stock price, climbing approximately 44% in after-hours trading following the FDA's approval of Bysanti (milsaperidone) for schizophrenia and acute bipolar I disorder. The drug, which metabolizes into iloperidone—the active component in Vanda's existing antipsychotic Fanapt—represents a significant expansion of the company's neurology portfolio.
Market enthusiasm contrasts with underlying financial concerns. Vanda operates with a negative operating margin and a precarious Altman Z-Score, raising questions about long-term sustainability despite the clinical win. The company targets a Q3 2026 U.S. launch while advancing phase 3 trials for major depressive disorder indications.