Why Intra-Cellular Therapies Is Skyrocketing Today
Intra-Cellular Therapies (NASDAQ: ITCI), a clinical-stage biopharma focused on diseases of the central nervous system, rose more than 26% as of 11:35 a.m. EDT Wednesday. The big jump came in response to the company sharing some upbeat regulatory news related to its lead compound lumateperone.
Management let investors know that the FDA has completed its review of the additional data that was submitted related to its nonclinical animal toxicology studies. The agency had previously raised concerns about lumateperone's safety since elevated levels of drug-related metabolites that were found in certain species of animal. In response, they asked Intra-Cellular to provide additional data to help show that the drug was safe for use in humans.
Investors learned on Wednesday that Intra-Cellular presented "adequate data to support its position that the metabolic pathway in the animal species is distinctive from humans, which indicates that the toxicity observed in the animal species is not relevant to humans."
Source: Fool.com
