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

by Vandana Singh, Benzinga Editor

February 22, 2021 1:15 PM | 1 min read | Make a Comment

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.

Posted In: Biotech News FDA General bipolar disorder

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