FDA Approves Intra-Cellular Therapies’ Novel Antipsychotic, CAPLYTA® (lumateperone) for the Treatment of Schizophrenia in Adults
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
NEW 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 score. The most common adverse reactions (=5% and twice the rate of placebo) for the recommended dose of CAPLYTA vs placebo were somnolence/sedation (24% vs.10%) and dry mouth (6% vs. 2%). In pooled data from short term studies, mean changes from baseline in weight gain, fasting glucose, triglycerides and total cholesterol were s
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News
- Intra-Cellular Therapies to Participate in Three Upcoming Investor Conferences [Yahoo! Finance]Yahoo! Finance
- Intra-Cellular Therapies to Participate in Three Upcoming Investor ConferencesGlobeNewswire
- Intra-Cellular Therapies Announces Presentations at the 2024 Psych Congress and NEI CongressGlobeNewswire
- Intra-Cellular bolsters Caplyta data with another Phase III win [Yahoo! Finance]Yahoo! Finance
- Intra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for the Prevention of Relapse in Patients with SchizophreniaGlobeNewswire
ITCI
Earnings
- 10/30/24 - Miss
ITCI
Sec Filings
- 11/14/24 - Form 4
- 11/12/24 - Form 144
- 11/12/24 - Form SC
- ITCI's page on the SEC website