Benzinga | Feb 22, 2021 01:15PM EST

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

* Intra-Cellular Therapies Inc (NASDAQ: ITCI) submits 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.