Intra-Cellular Therapies (ITCI) Stock: Taking A Dive On FDA Questions

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Intra-Cellular Therapies Inc (NASDAQ:ITCI) is having an incredibly rough day in the market today after providing a corporate update in which it informed investors of FDA concerns surrounding lumateperone. Of course, this led to concerns among investors and declines in the stock. As is usually the case, our partners at Trade Ideas were the first to alert us to the declines. At the moment (9:58), ITCI is trading at $8.70 per share after a loss of $5.12 per share or 37.05% thus far today.





ITCI Falls On FDA Concerns

As mentioned above, Intra-Cellular Therapies is having a rough start in the trading session this morning following the release of a corporate update. The update surrounded lumateperone development as a treatment for schizophrenia. While the company stated that the FDA believes their schizophrenia clinical development program collectively provides evidence of the efficacy and safety of lumateperone for the treatment of schizophrenia, the FDA also had some concerns of its own, leading to concerns among investors. In fact, this paragraph from the ITCI press release was the big kicker…




The FDA has raised questions, however, relating to certain findings observed in nonclinical animal toxicology studies of lumateperone and has requested additional information to confirm that the nonclinical findings are not indicative of a safety risk associated with long term exposure in humans. These findings only occurred in one of the nonclinical toxicology species and only after high exposure to drug related material. We and our expert consultants believe these findings are not indicative of a safety risk for humans due to species differences in the metabolism of lumateperone. In humans, lumateperone and its metabolites are rapidly eliminated from the body and there is no retention of drug or drug related material. In the animal species in question, a substantial amount of drug related metabolites are retained for an extended period of time and metabolites are formed in this species that are not detected in humans. As we have previously disclosed, in our clinical trials of lumateperone in schizophrenia up to and including 6 weeks treatment duration in humans, lumateperone has a favorable safety and tolerability profile with the incidence of movement disorders and cardiometabolic adverse events similar to placebo and statistically significantly better on several key safety and tolerability parameters than risperidone, the most frequently prescribed antipsychotic for the treatment of schizophrenia. The FDA has not raised any safety concerns regarding the study of lumateperone in short term treatment trials in humans, including our completed schizophrenia clinical trials and our ongoing Phase 3 clinical trials in bipolar depression and agitation associated with dementia, including Alzheimer’s disease. With over 1500 people exposed to date, lumateperone has been well-tolerated with a safety profile similar to placebo.”

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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 ongoing development with regard to lumateperone. While there are some concerns surrounding the treatment, there’s also potential for positive news ahead. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks.

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