Vanda Scores FDA Approval For BYSANTI, Its Second Regulatory Nod In Less Than Two Months

Core Viewpoint - Vanda Pharmaceuticals Inc. (VNDA) shares surged over 40% in after-hours trading following FDA approval of BYSANTI, a new treatment for bipolar I disorder and schizophrenia in adults [1] Group 1: Product Approval and Market Impact - The FDA has approved BYSANTI as a first-line therapy for acute treatment of manic or mixed episodes associated with bipolar I disorder and for schizophrenia in adults [1] - BYSANTI is expected to be commercially available in the third quarter of this year [1] - Following the approval, VNDA shares closed at $5.76, down 5.57% during regular trading, but rose to $8.30 in after-hours trading [3] Group 2: Intellectual Property and Future Developments - BYSANTI will be protected by regulatory data exclusivity and U.S. patents, with the last patent expiring in 2044, which supports long-term innovation and patient benefits [2] - This approval marks the second new drug for Vanda in less than two months, following the approval of NEREUS for motion-induced vomiting in December 2025 [3] - A phase 3 trial for BYSANTI as a once-daily adjunctive treatment for major depressive disorder (MDD) is currently underway, with results expected this year [3] Group 3: Stock Performance - VNDA has traded between $3.81 and $9.60 over the past year [3]