We recently covered Intra-Cellular Therapies (ITCI) on Seeking Alpha. On Friday, the company completed the rolling submission of its NDA for lumateperone for the treatment of schizophrenia. Given 3 months for acceptance and another 6 for PDUFA date (the drug is Fast Tracked for the indication), we expect a PDUFA date of no later than July 2019.
The NDA is backed by 20 clinical trials and data from more than 1900 subjects who have taken lumateperone. As we said in our coverage, what differentiates lumateperone is that, besides its demonstrated efficacy, its particular MOA makes it much safer than the competition. We are aware of the FDA’s increasing focus on safety and lack of adverse side effects when it comes to CNS drugs especially in the elderly, so lumateperone’s safety profile will be highly critical when it comes to the PDUFA.