Intra-Cellular Therapies Announces FDA Advisory Committee Meeting to Review the NDA for 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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US:NASDAQ Investor Relations:
ir.intracellulartherapies.com/investor-relations
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Source: GlobeNewswire
NEW YORK, June 13, 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 the U.S. Food and Drug Administration (FDA) has announced a Psychopharmacologic Drugs Advisory Committee meeting to be held on July 31, 2019 to discuss the New Drug Application (NDA) for lumateperone with the proposed indication of treatment of schizophrenia in adults. Lumateperone is a novel investigational drug with an NDA currently under review by FDA as a treatment of schizophrenia in adults. FDA’s expected Prescription Drug User Fee Act (PDUFA) action date is September 27, 2019. “There remains a significant unmet medical need in the treatment of schizophrenia,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We welcome the opportunity to present our data at the Advisory Committee meeting as we continue working to bring lumateperone
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- Intra-Cellular Therapies to Participate in Three Upcoming Investor ConferencesGlobeNewswire
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- 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