Intra-Cellular Therapies Inc (NASDAQ: ITCI) shares were volatile Tuesday after the actively traded, small-cap biotech announced that the FDA has informed the company that it does not plan to hold an Advisory Committee meeting with regard to the review of the company's NDA for lumateperone.
Lumateperone is the company's investigational asset that is being evaluated for the treatment of schizophrenia.
The company said it has recently submitted to the FDA the results of non-clinical analyses related to toxicology findings in animal studies.
Intra-Cellular said it believes the results support its deduction that the metabolic pathway and the metabolites produced are different in animals and humans. Therefore, toxicity findings in animals are not relevant to humans, the company said.
"We have been working diligently to address the FDA requests for information and are optimistic that the additional non-clinical information we submitted addresses those requests," said Dr. Sharon Mates, the company's chairman and CEO.
The PDUFA goal date for the investigational therapy is scheduled for Dec. 27 following a previously announced three-month extension.
After rising as much as 8.2% early in pre-market trading Tuesday, the stock was down 6.1% at the time of publication.
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