Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) Files An 8-K Other Events
ITEM 8.01
99.1 | Press release dated July 8, 2019 |
Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) Files An 8-K Other Events
ITEM 8.01
99.1 | Press release dated July 8, 2019 |
Intra-Cellular Therapies, Inc. Exhibit
EX-99.1 2 d898004dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Intra-Cellular Therapies Announces Positive Top-line Results from a Phase 3 Trial of Lumateperone in Patients with Bipolar Depression Study 404 met its primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p<0.001; effect size = 0.56). Study 404 also met its key secondary objective on the Clinical Global Impression Scale for Bipolar for Severity of Illness (CGI-BP-S) Total Score (p<0.001; effect size = 0.46); lumateperone also positive on the CGI component that specifically assesses depression (CGI-BP-S Depression Score; p<0.001; effect size = 0.50). Study 404 benefits were statistically significant in both Bipolar I and Bipolar II patients. In Study 401,…
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About Intra-Cellular Therapies, Inc. (NASDAQ:ITCI)
Intra-Cellular Therapies, Inc. (ITI) is a biopharmaceutical company. The Company is focused on the discovery and clinical development of small molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system (CNS). The Company’s pipeline includes approximately two product candidates in clinical development and two product candidates in advanced pre-clinical testing. Its platform includes ITI-007 platform and phosphodiesterase (PDE) Inhibitor Platform. It is developing its lead drug candidate, ITI-007, for the treatment of schizophrenia, behavioral disturbances associated with dementia, autism and other CNS diseases. Its ITI-007 platform also includes long acting injectable (LAI) program, and IC200131 program for mood and other disorders. Its PDE Inhibitor Platform includes PDE1 program and PDE2 and PDE9 programs.