Intra-Cellular Therapies Files Supplemental NDA for Caplyta as Adjunctive Treatment for Major Depressive Disorder

MT Newswires Live12-03

Intra-Cellular Therapies (ITCI) filed a supplemental new drug application with the US Food and Drug Administration for Caplyta as an add-on treatment for major depressive disorder.

The submission is backed by two positive phase 3 studies demonstrating the drug's "robust antidepressant efficacy and favorable safety and tolerability profile," the company said Tuesday in a statement.

If approved, Caplyta, or lumateperone, would be indicated for three major psychiatric conditions affecting 30 million adult patients in the US, the company said.

Shares of the company fell 0.8% in recent Tuesday trading.

Price: 85.31, Change: -0.72, Percent Change: -0.84

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