Intra-Cellular Therapies Offers New Hope for Treating Depression

Shares in Intra-Cellular Therapies (Nasdaq: ITCI) rose 9.60% on Tuesday to reach $75.48 after the company announced positive topline data from a study evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). The study achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints, with lumateperone 42 mg robustly improving depressive symptoms.

Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies, commented, “We are confident that the efficacy results from Studies 501 and 502, along with the favorable safety and tolerability profiles from these studies, will make lumateperone a drug of choice for patients suffering with MDD who are having an inadequate response to antidepressant therapy. We are very pleased with the robust efficacy results from Study 502 which are consistent with the compelling results from Study 501.”

The company expects to submit a supplemental New Drug Application (sNDA) to the FDA in the second half of 2024.

Major Depressive Disorder (MDD) affects an estimated 21 million adults in the US each year.

About Intra-Cellular Therapies

Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.