Vanda Gets FDA Approval for Bysanti in Schizophrenia, Bipolar I Disorder; Shares Up Pre-Bell

MT Newswires Live

02/23

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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