Share Surge

On Monday, Vanda Pharmaceuticals’ shares surged 33 % after the U.S. FDA approved Bysanti (milsaperidone) for treating bipolar I disorder and schizophrenia. Bysanti is the active metabolite of Fanapt (iloperidone) and has shown bioequivalence to the parent drug. The approval is seen as a turning point for Vanda, which had previously traded at a discount amid uncertainty. Investors now view the FDA decision as a catalyst for significant revenue growth. In addition to the new indication, Bysanti is advancing in a Phase 3 trial as an add‑on therapy for major depressive disorder, suggesting further market potential.