May 8, 2017 (Shareholders Foundation) - An investigation on behalf of investors of Intra-Cellular Therapies Inc (NASDAQ:ITCI) shares over potential securities laws violations by Intra-Cellular Therapies and certain of its directors and officers in connection certain financial statements was announced.

The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of Intra-Cellular Therapies Inc (NASDAQ:ITCI) concerning whether a series of statements by Intra-Cellular Therapies regarding its business, its prospects and its operations were materially false and misleading at the time they were made.

New York Based Intra-Cellular Therapies, Inc. is a biopharmaceutical company that is discovering and developing drugs for the treatment of neurological and psychiatric disorders and Lumateperone (also known as ITI-007) is its lead product candidate.

On August 4, 2016, Intra-Cellular Therapies CEO Sharon Mates specified during an earnings call that 'our studies to-date supports the efficacy and safety of ITI-007 for the treatment of schizophrenia.'

On September 28, 2016, Intra-Cellular Therapies Inc (NASDAQ:ITCI) announced top-line results from the second Phase 3 clinical trial (Study 302) of ITI-007, an oral, first-in-class investigational medicine for the treatment of schizophrenia. Intra-Cellular Therapies Inc said that in this trial, neither dose of ITI-007 separated from placebo on the primary endpoint, change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score, in the pre-defined patient population, while risperidone, an approved schizophrenia drug, did separate from placebo.

On May 1, 2017, Intra-Cellular Therapies Inc revealed that U.S. Food and Drug Administration had requested further information to verify that the findings observed in nonclinical animal toxicology studies of lumateperone are not suggestive of a safety risk associated with long term exposure in humans.

Shares of Intra-Cellular Therapies Inc (NASDAQ:ITCI) declined from $42.40 per share on September 28, 2016 to as low as $9.04 per share on May 4, 2017.