Vanda Pharmaceuticals’ BYSANTI Approval Sparks 44% Stock Surge
Vanda Pharmaceuticals Inc. (VNDA) shares rallied as much as 44% in after-hours trading following FDA approval of its novel antipsychotic drug BYSANTI. The New Chemical Entity designation grants patent protection until 2044, creating a nearly two-decade window without generic competition.
The milestone marks Vanda's second FDA approval within two months, following December 2025's NEREUS clearance. BYSANTI's accelerated approval timeline and upcoming Q3 2026 launch position the small-cap biotech for potential transformation. Depression trial results expected by year-end 2026 could further catalyze growth.