• Johnson & Johnson's Caplyta met primary and key secondary endpoints in its second pivotal Phase 3 trial in adults with bipolar I mania.
• Manic symptoms improved versus placebo as early as Day 3, with benefits sustained through Week 3; tolerability was consistent with prior studies.
• Two positive pivotal studies will support a planned U.S. regulatory submission for bipolar mania, an indication for which Caplyta is not approved.
• Study 452 results were presented at the Neuroscience Education Institute Fall Congress, held November 5-8, 2026, in Colorado Springs.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Johnson & Johnson published the original content used to generate this news brief via PR Newswire (Ref. ID: 202611100800PR_NEWS_USPR_____CG93337) on November 10, 2026, and is solely responsible for the information contained therein.