Intra-Cellular Therapies Inc. said the U.S. Food and Drug Administration has agreed to let the company submit additional information regarding its new drug application for lumateperone to treat schizophrenia.
The FDA classified the planned submission as a major amendment to the application and extended the review period by three months. The U.S. regulator plans to make a decision on the New York-based pharmaceutical company's application by Dec. 27.
The new information will cover findings from previous animal studies that show species-specific differences in the breakdown of the drug. Additionally, Intra-Cellular will analyze animal and human plasma samples from previous studies to confirm that lumateperone goes through different chemical reactions in different species.
Intra-Cellular's application for lumateperone is based on results from 20 clinical studies. The FDA granted a fast-track designation to the drug for treating patients with schizophrenia in November 2017.
The pharmaceutical company is also developing lumateperone as a therapy for bipolar disorder, behavioral disturbances in patients with Alzheimer's disease, depression, and other neuropsychiatric and neurological disorders.
The shares of Intra-Cellular were up 8.39% to $8.85 at 1:49 p.m. on Aug. 5.