- 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.
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