Intra-Cellular Therapies to Host Conference Call to Provide Regulatory Update Following Recent Meeting with FDA
Intra-Cellular Therapies Inc. (ITCI)
Last intra-cellular therapies inc. earnings: 3/2 07:30 am
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US:NASDAQ Investor Relations:
ir.intracellulartherapies.com/investor-relations
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Source: GlobeNewswire
Agreement reached with FDA on submission of additional non-clinical information for NDA review of lumateperone for the treatment of schizophreniaLumateperone PDUFA goal date extended three months to December 27, 2019 Conference call scheduled today at 8:30 am ET NEW YORK, Aug. 05, 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 it recently met with the U.S. Food and Drug Administration (FDA) and reached agreement to submit additional non-clinical information in connection with the FDA’s ongoing review of the Company’s New Drug application (NDA) for lumateperone for the treatment of schizophrenia. The FDA has informed the Company that the planned submission of this additional information constitutes a major amendment to the NDA, resulting in a three-month extension of the Prescription Drug User Fee Act (PDUFA) goal date to D
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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