10:59 AM EST, 12/03/2024 (MT Newswires) -- 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