Health and Healthcare
Is Intra-Cellular's Schizophrenia Treatment in Trouble?
Published:
Last Updated:
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.
24/7 Wall St.The Average American Is Losing Their Savings Every Day (Sponsor)
If you’re like many Americans and keep your money ‘safe’ in a checking or savings account, think again. The average yield on a savings account is a paltry .4% today, and inflation is much higher. Checking accounts are even worse.
Every day you don’t move to a high-yield savings account that beats inflation, you lose more and more value.
But there is good news. To win qualified customers, some accounts are paying 9-10x this national average. That’s an incredible way to keep your money safe, and get paid at the same time. Our top pick for high yield savings accounts includes other one time cash bonuses, and is FDIC insured.
Click here to see how much more you could be earning on your savings today. It takes just a few minutes and your money could be working for you.
Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.
Latest from 24/7
