Vanda Pharmaceuticals achieved a significant milestone with FDA approval of BYSANTI, marking its second major regulatory win in less than two months.

Vanda Pharmaceuticals achieved a significant milestone with FDA approval of BYSANTI, marking its second major regulatory win in less than two months. BYSANTI, a first-line atypical antipsychotic therapy, is approved for acute treatment of manic or mixed episodes in bipolar I disorder and schizophrenia in adults. The drug will launch commercially in the third quarter and benefits from patent protection extending through 2044, providing substantial long-term revenue potential. Following this approval, Vanda shares surged over 40% in after-hours trading. The company also has an ongoing phase 3 trial for BYSANTI as an adjunctive treatment for major depressive disorder with results expected this year. These consecutive approvals demonstrate Vanda's strengthening pipeline and position the company for meaningful growth in the psychiatric medication market.