Johnson & Johnson Says Caplyta Meets Primary Endpoint in Late-Stage Bipolar Mania Trial

09:59 AM EDT, 09/21/2026 (MT Newswires) -- Johnson & Johnson (JNJ) said Monday that its pivotal late-stage trial evaluating Caplyta for manic episodes in adults with bipolar I disorder has met its primary endpoint. The study showed a statistically significant reduction in manic symptoms compared to placebo at three weeks, with improvements observed as early as day three, the company said. Patients receiving the treatment also demonstrated statistically significant gains in overall illness severity, while the drug was generally well-tolerated, with common side effects limited to dry mouth and nausea, Johnson & Johnson said. The company said that a second late-stage study evaluating Caplyta for the treatment of manic episodes in adults with bipolar I disorder has been completed, and data analysis is underway. Shares of the company were up 1% in recent Monday trading. Price: 272.34, Change: +2.34, Percent Change: +0.87