Intra-Cellular jumps on resolution of toxicity concerns

Intra-Cellular Therapies Inc. (NASDAQ:ITCI) gained $3.12 (28%) to $14.39 on Wednesday after it said FDA agreed that the company provided adequate data indicating that a toxicity signal seen in animal studies of schizophrenia candidate lumateperone (ITI-007) is not relevant to humans. Intra-Cellular’s stock price has rebounded since falling 24% to $10.49 on May 1, when FDA raised concerns with preclinical toxicology evidence following high levels of exposure to the product and requested additional data (see BioCentury Extra, May 1).

Based on agency feedback, the company reiterated plans to submit an NDA to FDA for lumateperone to treat schizophrenia by mid-2018 and said it will move forward with its ongoing long-term safety study of the product. That study will now include additional measures to monitor for metabolites that have been observed in animals treated with lumateperone...