The U.S. Food and Drug Administration approved Intra-Cellular Therapies Inc.’s Caplyta for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate.

New York-based Intra-Cellular Therapies published the results of the company’s Study 404 phase III trial of lumateperone as monotherapy for major depressive episodes associated with bipolar I or bipolar II disorder. 

Sage Therapeutics ended two late-stage studies of the depression drug zuranolone after discussions with the U.S. Food and Drug Administration led the company to believe they were unnecessary for potential regulatory approval.

Intra-Cellular Therapies Inc.’s lead drug failed to meet the main goal of a late-stage study in patients with major depressive episodes associated with bipolar disorder.