|Bid||8.02 x 1100|
|Ask||9.52 x 1000|
|Day's Range||8.28 - 8.80|
|52 Week Range||7.41 - 23.62|
|Beta (3Y Monthly)||1.29|
|PE Ratio (TTM)||N/A|
|Earnings Date||Aug 3, 2017 - Aug 7, 2017|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||25.89|
Intra-Cellular Therapies Inc (NASDAQ: ITCI) shares were volatile Tuesday after the actively traded, small-cap biotech announced that the FDA has informed the company that it does not plan to hold an Advisory Committee meeting with regard to the review of the company's NDA for lumateperone. Lumateperone is the company's investigational asset that is being evaluated for the treatment of schizophrenia. The company said it has recently submitted to the FDA the results of non-clinical analyses related to toxicology findings in animal studies.
Intra-Cellular Therapies, Inc. (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.
Sharon Mates has been the CEO of Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) since 2013. First, this article will...
NEW YORK, Aug. 07, 2019 -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system.
Intra-Cellular Therapies, Inc. (ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the Canaccord Genuity 39th Annual Growth Conference in Boston. The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson's and Alzheimer's disease.
Agreement reached with FDA on submission of additional non-clinical information for NDA review of lumateperone for the treatment of schizophreniaLumateperone PDUFA goal date.
Intra-Cellular Therapies, Inc. (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 cancelled the Psychopharmacologic Drugs Advisory Committee meeting scheduled for July 31, 2019 to discuss the New Drug Application (NDA) for lumateperone for the treatment of schizophrenia. The Company has a meeting scheduled with the FDA shortly and will provide an update following the meeting.
Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) is a company with exceptional fundamental characteristics. Upon building...
This most-searched list is a feature included in Benzinga Pro's Newsfeed tool. It highlights stocks frequently searched by Benzinga Pro users on the platform. Soliton, Inc. (NASDAQ: SOLY ) shares were ...
Intra-Cellular Therapies' (ITCI) lead candidate fails to meet primary endpoint in one of the phase III studies evaluating it in bipolar depression patients. Shares fall.
Shares of biotech Intra-Cellular Therapies fell 15% in premarket trade Monday after the company announced disappointing results from a late-stage trial of its lead drug candidate lumateperone, a potential bipolar depression treatment. The trial, which evaluated 554 patients with bipolar disorder in the U.S., showed that lumateperone was no better than a placebo in helping to relieve symptoms of depression in patients with bipolar disorder. However, Intra-Cellular also announced positive results in a separate global trial of the drug looking at 381 patients with bipolar disorder from around the world. This Phase 3 trial met its primary endpoint; after six weeks of treatment, patients on the drug showed statistically-significant improvement over those on placebo. Intra-Cellular is also conducting a third trial of the drug, looking at it as an adjunctive therapy to lithium or valproate. In early July, Ritu Baral of Cowen said Intra-Cellular would need two positive trials to support filing a new drug application, or NDA. If both the U.S. and global trials looking at lumateperone showed positive results, the company would be able to file an NDA sometime in the second half of 2019, she wrote in a note to clients last week. But if only one of the trials was positive, the company would have to wait for data from the third trial -- evaluating lumateperone as an adjunctive therapy -- to come out. That data won't be available until 2020, she wrote. Shares of Intra-Cellular have gained 18.2% in the year to date through Friday, while the S&P 500 has gained 19.3%.
Intra-Cellular Therapies (NASDAQ: ITCI ) shares resumed trading after the company released mixed study results from two Phase 3 clinical trials evaluating lumateperone as monotherapy in the treatment of ...
Intra-Cellular Therapies Inc said on Monday its lead drug failed to meet the main goal of one of two late-stage studies in patients with major depressive episodes associated with bipolar disorder. The company's shares fell 6.5% 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.
Intra-Cellular Therapies Inc. on Monday reported positive results from two late-stage trials of a treatment for bipolar depression. The New York-based company said the two phase 3 trials of lumateperone met their primary endpoints. In Study 404, that goal was change from baseline at week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo. Study 404 also met its key secondary endpoint, on the Clinical Global Impression Scale for Bipolar for Severity of Illness, or CGI-BP-S. That study produced positive results for patients with Bipolar type I and Bipolar type 2. "In Study 401, lumateperone did not separate from placebo," the company said in a statement. "A high placebo response was observed in the trial." Study 404 was conducted globally, including in the U.S. and included 381 patients. Study 401 was conducted only in the U.S. and involved 554 patients. "Consistent with previous studies in schizophrenia, lumateperone was well-tolerated in both bipolar depression studies, with a favorable safety profile," said the statement. Shares were halted for the news, but have gained 18.2% in 2019, while the S&P 500 has gained 19.3%.
Study 404 met its primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p
Biotech stocks saw muted sentiment in the holiday-shortened week ending July 5 after a strong rebound in the later part of the previous week. Activity was light, although news on clinical trial readouts ...
Investors need to pay close attention to Intra-Cellular Therapies (ITCI) stock based on the movements in the options market lately.