10:15 AM EDT, 03/31/2025 (MT Newswires) -- Vanda Pharmaceuticals ( VNDA ) said Monday that it submitted a new drug application with the US Food and Drug Administration requesting marketing approval for Bysanti to treat acute bipolar I disorder and schizophrenia.

The company started a phase 3 study of the drug as a once-daily add-on treatment for major depressive order in Q4, with results expected in 2026.

Shares of the company were down 2.1% in recent trading.

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