Johnson & JohnsonCaplyta hit its primary endpoint in the pivotal phase III Study 451 for bipolar I mania, supporting a potential label expansion toward $5B peak sales.

Johnson & Johnson announced positive top-line data from a pivotal phase III study evaluating Caplyta (lumateperone) for treating manic episodes, with or without mixed features, in adults with bipolar I disorder. In Study 451, the first of two pivotal phase III studies of Caplyta in bipolar I mania, patients treated with once-daily Caplyta (42 mg) achieved a 4.8-point greater reduction in Young Mania Rating Scale total score versus placebo at week three, with significant improvement seen as early as day three, the study's primary endpoint. The proportion of patients achieving at least a 50% reduction in YMRS total score was more than twice as high with Caplyta as with placebo, at 45.8% versus 20.9%, respectively, and the safety and tolerability profile was similar to Caplyta's established profile. Management noted that the second pivotal phase III study, Study 452, has been completed, with data analysis underway. Caplyta, an atypical antipsychotic added to J&J's neuroscience portfolio through the 2025 acquisition of Intra-Cellular Therapies, generated sales of $631 million in the first half of 2026 and is not presently approved for the treatment of manic episodes associated with bipolar I disorder; J&J believes it has the potential to deliver peak sales of $5 billion.
Johnson & JohnsonCaplyta hit its primary endpoint in the pivotal phase III Study 451 for bipolar I mania, supporting a potential label expansion toward $5B peak sales.
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