Shares of Intra-Cellular Therapies Inc. ITCI jumped about 15% in premarket trading on Tuesday after the company said its experimental treatment for major depressive disorder met the primary endpoint in a Phase 3 clinical trial. The drug, lumateperone, is being tested as a treatment for episodes associated with major depressive disorder and bipolar depression with fixed features, which are manic symptoms. It’s already approved to treat schizophrenia and depressive episode under the name Caplyta. “Today’s strong data will likely encourage the FDA to take a serious look at ITCI’s package to potentially expand the label for a formal mixed features indication,” RBC Capital Markets analyst Brian Abrahams told investors on Tuesday. Intra-Cellular’s stock is down 9.5% so far this year, while the broader S&P 500 SPX has gained 4.0%.
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