Vanda Pharmaceuticals (VNDA) said Monday that the US Food and Drug Administration has accepted the new drug application for Bysanti to potentially treat bipolar I disorder and schizophrenia, with a target decision date of Feb. 21, 2026.
The FDA has not identified any potential review issues at this time, Vanda said.
The company said the application is supported by data from studies in acute episodes of schizophrenia, a study in bipolar I disorder with manic or mixed episodes, and a relapse prevention study in schizophrenia.
Bysanti is currently being evaluated as a once-daily add-on treatment for major depressive disorder, with results expected in 2026, the biopharmaceutical company said.
Shares of Vanda Pharmaceuticals were down more than 2% in recent Monday trading.
Price: 4.47, Change: -0.10, Percent Change: -2.19
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