Intra-Cellular Therapies Inc. (NASDAQ: ITCI) saw an incredible gain in its shares early on Wednesday after the U.S. Food and Drug Administration (FDA) gave a positive regulatory update on the firm’s schizophrenia program.
According to the FDA, the agency has completed its review of certain findings observed in nonclinical toxicology studies of lumateperone in an animal species. The FDA agrees that Intra-Cellular has 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.
As a result, Intra-Cellular is moving forward with its long-term safety study of lumateperone and intends to submit a new drug application (NDA) for the treatment of schizophrenia by mid-2018.
Further, based on feedback from the FDA, the company will incorporate additional monitoring in its long-term safety study for metabolites seen in animal species but not seen to date in humans. It will also continue to monitor for toxicities in its nonclinical studies. With over 1,500 people exposed to date, lumateperone has been well-tolerated with a safety profile similar to placebo.
Dr. Sharon Mates, board chair and chief executive of Intra-Cellular, commented:
We are very pleased with the outcome of our discussions with the FDA and look forward to progressing our schizophrenia program.
Excluding Wednesday’s move, Intra-Cellular had underperformed the broad markets, with the stock down about 25% year to date. Over the past 52 weeks, the stock was down just over 70%.
Shares of Intra-Cellular traded up more than 30% at $14.70 just after Wednesday’s opening bell. The consensus analyst price target is $21.71 and a 52-week range of $7.85 to $45.20.