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 company is planning a direct-to-consumer education campaign to inform the public about the importance of vaccination.
The company showcased its pipeline in a two-day virtual meeting, trying to convince investors the long-term potential is undervalued.