08:53 AM EDT, 06/18/2024 (MT Newswires) -- Intra-Cellular Therapies ( ITCI ) said Tuesday that its investigational adjunctive therapy, lumateperone, for treating patients with major depressive disorder, met both the primary and key secondary endpoints in the second late-stage study.

The study showed that the therapy resulted in a statistically significant and clinically meaningful reduction in the overall score of Montgomery-Asberg depression rating scale at Week 6 compared to placebo, the company said.

The company said lumateperone has also demonstrated a statistically significant and clinically meaningful reduction in the CGI-S score compared to placebo at Week 6.

Intra-Cellular said it plans to submit a supplemental new drug application for lumateperone as an adjunctive therapy for major depressive disorder in H2.

The company's shares were up more than 9% in recent Tuesday premarket activity.

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