Johnson & Johnson announced a new analysis of data from three Phase III studies of Caplyta (lumateperone) in adult patients with major depressive disorder (MDD).[2] Caplyta in combination with an antidepressant significantly increased remission rates compared with placebo plus an antidepressant at six weeks.[2] In pooled data from the main studies, almost twice as many patients achieved remission (MADRS ≤10) with adjunctive Caplyta.[2] In Study 501, the difference in MADRS score was 4.9 points (effect size 0.61) versus placebo, and in Study 502 it was 4.5 points (effect size 0.56).[2] In a six-month open-label extension (Study 503, n=809), efficacy was maintained, with 80% of patients responding and 65% achieving remission (MADRS ≤10).[2] No patient reported severe suicidal ideation or behavior.[2] Depressive symptoms improved by −22.9 points on the MADRS and −2.7 points on the CGI-S from baseline to 26 weeks.[2]