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Intra-Cellular Therapies Files US Application For Expanded Use Of Lumateperone In Bipolar Settings

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  • Intra-Cellular Therapies Inc (NASDAQ: ITCIsubmits CAPLYTA (lumateperone) supplemental marketing application to the FDA to treat depressive episodes associated with bipolar I or II disorder in adults.
  • The application seeks approval for two indications of CAPLYTA; as monotherapy and as adjunctive therapy with lithium or valproate.
  • The Company anticipates an FDA target action date for the application in the second half of 2021.
  • CAPLYTA is indicated for the treatment of schizophrenia in adults.
  • Price Action: ITCI decreased 1.70% at $38.84 in market trading hours on the last check Monday.
 

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Posted-In: bipolar disorderBiotech News FDA General

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