Intra-Cellular gets lumateperone reprieve, for now

Industry watchers might be forgiven for thinking that Intra-Cellular Therapies has finally had some good news after its stock rose 8% yesterday. However, the company has merely avoided the worst-case scenario of an outright US FDA rejection for its lead project, lumateperone, in schizophrenia. The agency is now set to make a decision on lumateperone by December 27, a three-month delay to the previous PDUFA date – a fairly benign outcome for investors who had feared a complete response letter after the FDA cancelled an adcom last month. But approval does not look any more likely given mixed phase III results and, now, a request from the agency for more preclinical data to address toxicity findings in previous animal studies. The in vitro analyses should not take the company long; however, a similar issue came up in 2017 following concerns about metabolites seen in dogs, and was thought to have been resolved. Intra-Cellular continues to insist that the metabolic pathway for lumateperone is different in humans and animals, and that it has not seen the metabolites in question in long-term human trials. Existing Intra-Cellular investors will have to hope that the FDA is merely being cautious.

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