Intra-Cellular Therapies Provides Lumateperone Regulatory Update
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
Company Research
Source: GlobeNewswire
FDA has informed the Company it has no plans to schedule an Advisory Committee Meeting Company has completed submission of non-clinical information previously agreed with FDA NEW YORK, Sept. 10, 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 informed the Company that it does not have plans to schedule an Advisory Committee meeting in connection with its review of the Company’s New Drug Application (NDA) for lumateperone for the treatment of schizophrenia. The lumateperone Prescription Drug User Fee Act (PDUFA) goal date is December 27, 2019. Additionally, the Company recently submitted to the FDA the results of non-clinical analyses the Company previously announced it had agreed to conduct related to toxicology findings in animal studies. The Company believes the results of
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News
- Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) had its price target raised by analysts at TD Cowen from $80.00 to $90.00. They now have a "buy" rating on the stock.MarketBeat
- Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) had its price target raised by analysts at Robert W. Baird from $83.00 to $103.00. They now have an "outperform" rating on the stock.MarketBeat
- Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) had its price target raised by analysts at Bank of America Co. from $82.00 to $91.00. They now have a "buy" rating on the stock.MarketBeat
- Intra-Cellular (ITCI) Up as Depression Drug Meets Study Goals [Yahoo! Finance]Yahoo! Finance
- Intra-Cellular (ITCI) Moves 23.3% Higher: Will This Strength Last? [Yahoo! Finance]Yahoo! Finance
ITCI
Earnings
- 2/22/24 - Beat
ITCI
Sec Filings
- 4/16/24 - Form 8-K
- 4/16/24 - Form 424B5
- 4/16/24 - Form S-3ASR
- ITCI's page on the SEC website