Intra-Cellular slips after FDA raises toxicology concern

Intra-Cellular Therapies Inc. (NASDAQ:ITCI) shed $3.33 (24%) to $10.49 on Monday after it said FDA requested additional preclinical toxicology information concerning lumateperone (ITI-007), its candidate to treat schizophrenia. The company hopes to submit an NDA for the product by mid-2018, but said FDA could place a clinical hold on its long-term safety study of lumateperone if it finds the company's response to be "insufficient."

The company said FDA was concerned with preclinical toxicology evidence following high levels of exposure. FDA has not issued any safety concerns with the company's completed or ongoing clinical trials, the company said. Lumateperone is a dual serotonin (5-HT2A) receptor antagonist and dopamine receptor phosphoprotein modulator (DPPM)...