Intra-Cellular Therapies (ITCI) Adds to Yesterday's Gain, Up 12% Pre-Market
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FDA Approves Intra-Cellular Therapies’ Novel Antipsychotic, CAPLYTA® (lumateperone) for the Treatment of Schizophrenia in Adults
December 23, 2019 6:59 AM ESTNEW YORK, Dec. 23, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that CAPLYTA® (lumateperone) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults. The Company expects to initiate the commercial launch of CAPLYTA in late Q1 2020.
The efficacy of CAPLYTA 42 mg was demonstrated in two placebo-controlled trials, showing a statistically significant separation from placebo on the primary endpoint, the Positive and Negative Syndrome Scale (PANSS) total... More
