Ladenburg Thalmann upgraded Intra-Cellular Therapies (NASDAQ:ITCI) to “buy” from “neutral” with a $36 price target, reflecting a positive update from the FDA about the company’s schizophrenia program. The stock closed at $15.90 on August 29.
Earlier this year, the FDA raised questions about a finding observed in the nonclinical animal toxicology studies of Intra-Cellular’s lumateperone, and requested additional information to confirm the findings that “now appear to be a non-issue in humans,” writes analyst Christopher James.
Mr. James said the FDA recently completed its review and agreed that the toxicity observed in the animal species is not relevant to humans.
As a result, he said the company is moving forward with its long-term safety study of lumateperone and intends to submit a new drug application for the treatment of schizophrenia by mid-2018.
“We remind investors of the advantages of lumateperone that include a lack of significant adverse effects on cardiovascular parameters, weight, lipids, glucose, prolactin and motor function,” he added.