04:01 AM EDT, 04/03/2024 (MT Newswires) -- Vanda Pharmaceuticals ( VNDA ) said late Tuesday its antipsychotic agent Fanapt has been approved by the US Food and Drug Administration for the acute treatment of bipolar I disorder patients with manic or mixed episodes.

The approval was based on data from a pivotal study which showed that the use of the drug led to a larger improvement in patients than placebo, the company said.

The drug has been previously approved as treatment for schizophrenia.

Shares of Vanda rose more than 30% in recent premarket activity on Wednesday.

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