Vanda Gets FDA Approval for Bysanti in Schizophrenia, Bipolar I Disorder; Shares Up Pre-Bell
MT Newswires Live
Feb 23
Vanda Pharmaceuticals (VNDA) said late Friday the US Food and Drug Administration approved Bysanti tablets as acute treatment for manic or mixed episodes related to bipolar I disorder and as schizophrenia treatment for adults.
The product is being tested as a once-daily adjunctive treatment in treatment-resistant major depressive disorder under an ongoing clinical study that is expected to be completed by year-end.
The company said it expects Bysanti to be commercially available in Q3.
Vanda shares were up 35% in recent premarket activity Monday.
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