Vanda Pharmaceuticals Inc.
Bysanti
bipolar I disorder and schizophrenia
Resolved
136days ago
FDA decision · Feb 21, 2026
What's at stake
The FDA's approval decision on Bysanti for bipolar I disorder and schizophrenia is due Feb 21, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 15h ago
“Bysanti NDA for bipolar I disorder and schizophrenia under review by the FDA; PDUFA target action date of February 21, 2026”