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Intra-Cellular Therapies Inc (ITCI.OQ)

ITCI.OQ on NASDAQ Stock Exchange Global Select Market

8.67USD
22 Aug 2019
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Latest Key Developments (Source: Significant Developments)

Intra-Cellular Therapies bipolar depression treatment fails one of two late-stage studies
Monday, 8 Jul 2019 

July 8 (Reuters) - Intra-Cellular Therapies Inc ::INTRA-CELLULAR THERAPIES ANNOUNCES POSITIVE TOP-LINE RESULTS FROM A PHASE 3 TRIAL OF LUMATEPERONE IN PATIENTS WITH BIPOLAR DEPRESSION.INTRA-CELLULAR THERAPIES INC - STUDY 404 MET ITS PRIMARY ENDPOINT.INTRA-CELLULAR THERAPIES INC - IN STUDY 401, LUMATEPERONE DID NOT SEPARATE FROM PLACEBO. A HIGH PLACEBO RESPONSE WAS OBSERVED IN TRIAL..INTRA-CELLULAR THERAPIES INC - STUDY 404 BENEFITS WERE STATISTICALLY SIGNIFICANT IN BOTH BIPOLAR I AND BIPOLAR II PATIENTS.INTRA-CELLULAR THERAPIES INC - STUDY 404 ALSO MET ITS KEY SECONDARY OBJECTIVE ON CLINICAL GLOBAL IMPRESSION SCALE FOR BIPOLAR FOR SEVERITY OF ILLNESS.INTRA-CELLULAR THERAPIES INC - STUDY 404 MET ITS KEY SECONDARY OBJECTIVE.INTRA-CELLULAR THERAPIES INC - FAVORABLE SAFETY AND TOLERABILITY PROFILE OBSERVED IN BOTH TRIALS, CONSISTENT WITH PRIOR LUMATEPERONE TRIALS.INTRA-CELLULAR THERAPIES INC - IN BOTH TRIALS, LUMATEPERONE DEMONSTRATED A FAVORABLE SAFETY PROFILE AND WAS GENERALLY WELL-TOLERATED.INTRA-CELLULAR THERAPIES INC - IN STUDY 404, LUMATEPERONE 42 MG MET PRIMARY ENDPOINT FOR IMPROVEMENT IN DEPRESSION.INTRA-CELLULAR THERAPIES INC - IN STUDY 401, NEITHER DOSE OF LUMATEPERONE MET PRIMARY ENDPOINT.INTRA-CELLULAR THERAPIES INC - THERE WAS A HIGH PLACEBO RESPONSE IN TRIAL OF STUDY 401.  Full Article

Intra-Cellular Therapies Reports Q1 2019 Results, Provides Corporate Update
Wednesday, 8 May 2019 

May 8 (Reuters) - Intra-Cellular Therapies Inc ::INTRA-CELLULAR THERAPIES REPORTS FIRST QUARTER 2019 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE.Q1 LOSS PER SHARE $0.63.Q1 EARNINGS PER SHARE ESTIMATE $-0.88 -- REFINITIV IBES DATA.CASH, CASH EQUIVALENTS AND INVESTMENT SECURITIES TOTALED $312.8 MILLION AT MARCH 31, 2019.CASH, CASH EQUIVALENTS AND INVESTMENT SECURITIES TOTALED $312.8 MILLION AT MARCH 31, 2019.  Full Article

Intra-Cellular Therapies Says FDA Has Assigned A Prescription Drug User Fee Act (PDUFA) Target Action Date Of Sept 27, 2019
Tuesday, 11 Dec 2018 

Dec 11 (Reuters) - Intra-Cellular Therapies Inc ::INTRA-CELLULAR THERAPIES ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR LUMATEPERONE FOR THE TREATMENT OF SCHIZOPHRENIA.INTRA-CELLULAR THERAPIES INC - FDA HAS ASSIGNED A PRESCRIPTION DRUG USER FEE ACT (PDUFA) TARGET ACTION DATE OF SEPTEMBER 27, 2019.  Full Article

Intra-Cellular Therapies Q3 Loss Per Share $0.76
Wednesday, 7 Nov 2018 

Nov 7 (Reuters) - Intra-Cellular Therapies Inc ::INTRA-CELLULAR THERAPIES PROVIDES CORPORATE UPDATE AND REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS.Q3 LOSS PER SHARE $0.76.Q3 EARNINGS PER SHARE VIEW $-0.84 -- THOMSON REUTERS I/B/E/S.  Full Article

Intra-Cellular Therapies Announces Positive Pre-NDA Meeting With FDA For Schizophrenia Treatment
Tuesday, 13 Mar 2018 

March 13 (Reuters) - Intra-Cellular Therapies Inc ::INTRA-CELLULAR THERAPIES ANNOUNCES POSITIVE PRE-NDA MEETING WITH FDA FOR LUMATEPERONE FOR THE TREATMENT OF SCHIZOPHRENIA.INTRA-CELLULAR THERAPIES INC - ‍FDA AGREED ON PROPOSED CONTENT AND TIMING OF A ROLLING NDA SUBMISSION​.INTRA-CELLULAR THERAPIES INC - ‍PLANS TO COMPLETE ITS NDA SUBMISSION BY MID-2018.​.INTRA-CELLULAR THERAPIES - ‍HAD POSITIVE PRE-NDA MEETING WITH FDA REGARDING LUMATEPERONE FOR TREATMENT OF SCHIZOPHRENIA​.  Full Article

Intra-Cellular Therapies Reports Q4 Loss Per Share $0.56
Thursday, 1 Mar 2018 

March 1 (Reuters) - Intra-Cellular Therapies Inc ::INTRA-CELLULAR THERAPIES REPORTS FOURTH QUARTER AND FULL-YEAR 2017 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE.Q4 LOSS PER SHARE $0.56.CASH, CASH EQUIVALENTS AND INVESTMENT SECURITIES TOTALED $464.3 MILLION AT DEC 31, 2017, VERSUS $384.1 MILLION AT DEC 31, 2016.INTRA-CELLULAR THERAPIES - EXPECTS CASH, CASH EQUIVALENTS AND INVESTMENT SECURITIES TO BE USED PRIMARILY TO ADVANCE LUMATEPERONE DEVELOPMENT PROGRAM.INTEND TO SUBMIT A NEW DRUG APPLICATION FOR LUMATEPERONE FOR TREATMENT OF SCHIZOPHRENIA BY MID-2018.PRE-NDA MEETING WITH FDA IS SCHEDULED TO BE HELD IN LATE Q1 2018 FOR LUMATEPERONE FOR TREATMENT OF SCHIZOPHRENIA.  Full Article

Intra-Cellular Therapies receives FDA fast track designation for Schizophrenia treatment drug
Monday, 20 Nov 2017 

Nov 20 (Reuters) - Intra-cellular Therapies Inc ::Intra-Cellular Therapies receives FDA fast track designation for lumateperone for the treatment of schizophrenia.Intra-Cellular Therapies Inc - ‍food and drug administration granted fast track designation for lumateperone for treatment of Schizophrenia​.  Full Article

Intra-Cellular Therapies Q3 loss per share $0.53
Wednesday, 8 Nov 2017 

Nov 8 (Reuters) - Intra-cellular Therapies Inc :Intra-Cellular Therapies reports third quarter 2017 financial results and provides corporate update.Q3 loss per share $0.53.Q3 earnings per share view $-0.62 -- Thomson Reuters I/B/E/S.Cash, cash equivalents, investment securities totaled $328.1 million at September 30, 2017, versus $384.1 million at December 31, 2016​.Expect to complete patient enrollment in our bipolar studies in 2018​.  Full Article

Intra-Cellular starts enrollment in ITI-214 clinical trial in patients with Parkinson’s disease
Tuesday, 3 Oct 2017 

Oct 3 (Reuters) - Intra-cellular Therapies Inc :Intra-Cellular therapies announces commencement of enrollment of a clinical trial evaluating ITI-214 in patients with Parkinson’s disease.  Full Article

Intra-Cellular Therapies prices 9.7 mln shares of common stock at $15.50 per share
Thursday, 28 Sep 2017 

Sept 27 (Reuters) - Intra-Cellular Therapies Inc - :Intra-Cellular therapies prices $150 million public offering of common stock.Announced pricing of previously announced underwritten public offering of 9,677,419 shares of stock at public offering price of $15.50/ share.  Full Article

Intra-Cellular drug fails bipolar depression study; shares fall 14%

Intra-Cellular Therapies Inc said on Monday its lead drug failed to meet the main goal of a late-stage study in patients with major depressive episodes associated with bipolar disorder.