Intra-Cellular Therapies Inc (NASDAQ: ITCI) is having an incredibly strong start to the trading session today, and for good reason. The company announced news with regard to the FDA, causing excitement among investors who are sending the stock toward the sky. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:22), ITCI is trading at $11.27 per share after a gain of $0.34 per share or 3.11% thus far today.
ITCI Gains On FDA News
As mentioned above, Intra-Cellular Therapies is having a strong day in the market today after announcing some key FDA news. The company said that the United States Food and Drug Administration has informed them that it has completed the review of the company’s responses to requests from the FDA for additional information. The requests surround certain findings observed in nonclinical toxicology studies of lumateperone in animal species. The FDA said that it agrees that ITCI has provided adequate data to support its position that the metabolic pathway in animal species is distinctive from humans, which indicates that toxicity observed in these animals is not relevant to humans.
This is overwhelmingly positive news. After all, after proving to the FDA that the toxicity does not apply to humans, the company is now able to move forward with its long-term safety study surrounding lumateperone. ITCI says that it intends to submit a new drug application for the indication of schizophrenia in mid-2018. In a statement, Dr. Sharon Mates, Chairman and CEI at Intra-Cellular Therapies, had the following to offer…
“We are very pleased with the outcome of our discussions with the FDA and look forward to progressing our schizophrenia program.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on ITCI. In particular, we’re interested in following the company’s ongoing work surrounding lumateperone and are excited to see the results of these efforts. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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