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Intra-Cellular Up on Positive Data from Schizophrenia Study

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Intra-Cellular Therapies, Inc. 's ITCI shares shot up 86.9% and hit a 52-week high of $49.75 on Sep 16 after the company announced encouraging data from its first phase III study on ITI-007 for the treatment of patients with schizophrenia.

The once-daily dose of ITI-007 (60 mg) met its primary and secondary efficacy endpoints. The candidate significantly improved social functioning compared to placebo, as measured by the Personal and Social Performance Scale. The candidate also demonstrated favorable safety and efficacy profile.

The second phase III study on ITI-007 is currently ongoing with data readout expected in mid-2016.

In addition, the company reported results from another study on ITI-007, using positron emission tomography (PET) in patients with schizophrenia who were otherwise healthy and stable with respect to their psychosis.

Apart from schizophrenia, ITI-007 is being evaluated for other indications including biopolar disorder, behavioral disturbances in dementia, depression, and other neuropsychiatric and neurological disorders. The company plans to initiate the first phase III study on ITI-007 for the treatment of biopolar depression later in the year. Moreover, ITI-007 is expected to enter late-stage clinical study for the treatment of Alzheimer's disease in the second half of 2015.

Other players in the schizophrenia treatment market include Saphris, Seroquel XR and many more.

We note that Alkermes plc's ALKS schizophrenia drug Aristada is currently under FDA review. A final decision from the FDA is expected shortly.

Intra-Cellular carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector include Gilead Sciences Inc. GILD and Regeneron Pharmaceuticals, Inc. REGN , each sporting a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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