Is Intra-Cellular’s Schizophrenia Treatment in Trouble?
Intra-Cellular saw its shares dip on Wednesday after the firm announced that the FDA has canceled a meeting scheduled for July 31 to discuss the New Drug Application for lumateperone for the treatment of schizophrenia.
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.
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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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Chris Lange is a financial and geopolitical writer with more than a decade of experience covering a myriad of topics. He has published thousands of articles for 24/7 Wall St., with past coverage focused heavily on stocks, IPOs, healthcare, defense, global affairs, and technology.
His work has been quoted, or referenced by a number of outlets including Business Insider, USA Today, Yahoo Finance, MSN, The Motley Fool, and many other publications. A graduate of Southwestern University, he studied business with a focus on investments and has previous experience in banking and startups.
When not reading or writing the news, he is following his passion for Lacrosse, playing chess, or building solar projects with his dad.
