Intra-Cellular drug fails bipolar depression study; shares fall 14% [Reuters (UK)]
Intra-Cellular Therapies Inc. (ITCI)
Last intra-cellular therapies inc. earnings: 3/2 07:30 am
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Source: Reuters
Intra-Cellular drug fails bipolar depression study; shares fall 14% - Reuters 3 Min Read (Reuters) - Intra-Cellular Therapies Inc said on Monday its lead drug failed to meet the main goal of a late-stage study in patients with major depressive episodes associated with bipolar disorder. The company’s shares fell 14% before the opening bell. The treatment, lumateperone, which is being studied as a monotherapy for the condition, failed to show statistically significant improvement in the disease condition compared to placebo in the trial, the company said. The study, conducted only in the United States, tested two doses of the treatment against placebo in 554 patients. However, a second global study which tested the treatment in 381 patients, met the main goal of statistically greater improvement in the severity of depressive symptoms over placebo. The treatment is also being evaluated as an add-on therapy to lithium or valproate in a third trial. If the drug succeeds as a monotherapy on
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ITCI
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