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Intra-Cellular stock more than doubles after US FDA approves schizophrenia drug

The U.S. Food and Drug Administration approved Intra-Cellular Therapies Inc.'s medicine Caplyta to treat adult patients with schizophrenia.

The New York-based biopharmaceutical company's stock price more than doubled on Dec. 23 following the news. The stocks were trading at $31.50 per share on Nasdaq as of 10:11 a.m. ET, up 153.22%.

Intra-Cellular said the approval of Caplyta, or lumateperone, was backed by data from two trials which showed that the drug was better than placebo in treating adult patients with schizophrenia — a chronic and severe mental disorder that affects how a person thinks, feels and behaves. The condition affects about 2.4 million adults in the U.S., the company said in a Dec. 23 press release.

In August, the FDA had requested additional information regarding Caplyta which had received the U.S. regulator's fast-track designation in November 2017.

Intra-Cellular said the company plans to begin the commercial launch of the drug in late first quarter of 2020.