Intra-Cellular Therapies Inc. shares (NAS:ITCI) soared 83% in premarket trade Monday, after the company said the U.S. Food and Drug Administration has approved a treatment for schizophrenia in adults. The New York-based biotech said the approval of its caplyta drug comes after two trials that showed a statistically significant separation from placebo. The company is expecting to start sales of the drug late in the first quarter of 2020. Schizophrenia is a serious mental illness that affects about 2.4 million adults in the U.S. and can cause such symptoms as hallucinations, delusions and psychosis. Intra-Cellular Therapies shares have gained 9% in 2019 through Friday, while the S&P 500 (S&P:SPX) has gained 28.5%.

Dec. 23, 2019, 8:00 a.m. EST