Shares of biotech Intra-Cellular Therapies /zigman2/quotes/209441868/composite ITCI +2.17% fell 15% in premarket trade Monday after the company announced disappointing results from a late-stage trial of its lead drug candidate lumateperone, a potential bipolar depression treatment. The trial, which evaluated 554 patients with bipolar disorder in the U.S., showed that lumateperone was no better than a placebo in helping to relieve symptoms of depression in patients with bipolar disorder. However, Intra-Cellular also announced positive results in a separate global trial of the drug looking at 381 patients with bipolar disorder from around the world. This Phase 3 trial met its primary endpoint; after six weeks of treatment, patients on the drug showed statistically-significant improvement over those on placebo. Intra-Cellular is also conducting a third trial of the drug, looking at it as an adjunctive therapy to lithium or valproate. In early July, Ritu Baral of Cowen said Intra-Cellular would need two positive trials to support filing a new drug application, or NDA. If both the U.S. and global trials looking at lumateperone showed positive results, the company would be able to file an NDA sometime in the second half of 2019, she wrote in a note to clients last week. But if only one of the trials was positive, the company would have to wait for data from the third trial -- evaluating lumateperone as an adjunctive therapy -- to come out. That data won't be available until 2020, she wrote. Shares of Intra-Cellular have gained 18.2% in the year to date through Friday, while the S&P 500 /zigman2/quotes/210599714/realtime SPX -0.23% has gained 19.3%.
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