Intra-Cellular's Lumateperone Poised For New Bipolar Depression Opportunity
The company is on track to file an sNDA for lumateperone after a Phase III clinical trial met the primary endpoint in bipolar I and II disorder.
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Firm will discuss Phase III data with the US FDA, calling results from a successful Phase III monotherapy study robust despite second Phase III study's failure. Lumateperone is under review for schizophrenia, with a 27 September action date.
The virtual J.P. Morgan Healthcare meeting was missing the usual energy but still had substance.
US vaccination campaign will pick up speed now that access is broadening, leaders from Operation Warp Speed, Pfizer, Moderna, McKesson and CVS Health say at a J.P. Morgan panel discussion.