Intra-Cellular Therapies Announces Positive Top-line Results from a Phase 3 Trial of Lumateperone in Patients with Bipolar Depression
Intra-Cellular Therapies Inc. (ITCI)
Last intra-cellular therapies inc. earnings: 3/2 07:30 am
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ir.intracellulartherapies.com/investor-relations
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Source: GlobeNewswire
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 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 Study 404 benefits were statistically significant in both Bipolar I and Bipolar II patients. In Study 401, lumateperone did not separate from placebo. A high placebo response was observed in the trial. Favorable safety and tolerability profile observed in both trials, consistent with prior lumateperone trials. Rates of akathisia, restlessness and extrapyramidal symptoms combined were less than 1% and similar to placebo in both studies. Conference call scheduled today at 8:00 a.m. ET NEW YORK, July 08, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) diso
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News
- Intra-Cellular Therapies Presents Data from the CAPLYTA Adjunctive MDD Phase 3 Program at the American College of Neuropsychopharmacology Annual Meeting [Yahoo! Finance]Yahoo! Finance
- Intra-Cellular Therapies Presents Data from the CAPLYTA Adjunctive MDD Phase 3 Program at the American College of Neuropsychopharmacology Annual MeetingGlobeNewswire
- ITCI Submits sNDA to the FDA for Expanded Use of Caplyta in MDD [Yahoo! Finance]Yahoo! Finance
- Intra-Cellular Therapies Submits Supplemental New Drug Application (sNDA) to FDA for CAPLYTA® (lumateperone) for the Treatment of Major Depressive Disorder as Adjunctive Therapy [Yahoo! Finance]Yahoo! Finance
- Intra-Cellular Therapies Submits Supplemental New Drug Application (sNDA) to FDA for CAPLYTA® (lumateperone) for the Treatment of Major Depressive Disorder as Adjunctive TherapyGlobeNewswire
ITCI
Earnings
- 10/30/24 - Miss
ITCI
Sec Filings
- 12/6/24 - Form 4
- 12/5/24 - Form 144
- 12/4/24 - Form 144
- ITCI's page on the SEC website