The FDA has informed Intra-Cellular Therapies (NASDAQ:ITCI) that it has no plans to schedule an Advisory Committee meeting regarding the Company’s NDA for lumateperone for the treatment of schizophrenia.
The lumateperone PDUFA goal date is December 27, 2019.
Additionally, the Company submitted the results of non-clinical analyses related to previous toxicology findings in animal studies.
The Company believes the results of these analyses provide additional support for its position that the metabolic pathway, and the metabolites formed, are different in animals and humans and therefore toxicity findings in animals are not relevant to humans.
Shares are up 6% premarket.
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