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! Fi...
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: Yahoo! Finance
CAPLYTA, if approved as an adjunctive therapy in MDD, would be indicated for the treatment of three different major psychiatry indications affecting over 30 million adult patients in the US BEDMINSTER, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, announced that it has recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CAPLYTA (lumateperone) for the treatment of Major Depressive Disorder (MDD) in adults, as adjunctive therapy to antidepressants. “MDD is a highly prevalent condition with a significant need for efficacious, safe, and well-tolerated medicines, as more than half of patients do not adequately respond to an antidepressant alone,” said Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies. “
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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 TherapyGlobeNewswire
- Why Is Intra-Cellular (ITCI) Up 2.2% Since Last Earnings Report? [Yahoo! Finance]Yahoo! Finance
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