Is Intra-Cellular’s Schizophrenia Treatment in Trouble?

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Intra-Cellular Therapies Inc. (NASDAQ: ITCI) saw its shares dip on Wednesday after the firm announced that the U.S. Food and Drug Administration (FDA) has canceled the Psychopharmacologic Drugs Advisory Committee meeting scheduled for July 31 to discuss the New Drug Application (NDA) for lumateperone for the treatment of schizophrenia.

The firm recently provided additional information to the FDA in response to information requests relating to non-clinical studies. The FDA canceled the Advisory Committee meeting to allow sufficient time to review this news and any forthcoming information as they continue the NDA review.

Ultimately, this information may result in an extension of the September 27, Prescription Drug User Fee Act (PDUFA) target action date for the lumateperone NDA.

As a result, Intra-Cellular has a meeting scheduled with the FDA shortly, and it will provide an update following the meeting.

Note that lumateperone is a molecule that provides selective and simultaneous modulation of serotonin, dopamine and glutamate, three neurotransmitter pathways implicated in severe mental illness.

Shares of Intra-Cellular traded down about 3.5% on Wednesday, at $7.90 in a 52-week range of $7.41 to $23.62. The consensus price target is $29.71.


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