Johnson & Johnson Says Caplyta Improves Manic Symptoms in Second Phase 3 Study

Johnson & Johnson's lumateperone (Caplyta) met primary and secondary endpoints in a phase 3 study for bipolar I disorder, showing significant improvement in manic symptoms by week 3. The study, presented at the 2026 NEI Fall Congress, supports a planned US regulatory submission. Caplyta demonstrated a 3.7-point greater reduction in YMRS score compared to placebo, with 43.9% of patients achieving a clinical response.

Johnson & Johnson reported that Caplyta, a drug it acquired through its purchase of Intra-Cellular Therapies, showed positive results in a late-stage trial for treating manic symptoms in bipolar I disorder. The trial found a 42 mg daily dose reduced mania scores by 3.7 points more than placebo, with nearly 44% of patients showing significant improvement. J&J plans to seek US FDA approval for this new indication, building on Caplyta's existing approvals for bipolar depression and schizophrenia.

Johnson & Johnson (JNJ) reported positive results from a second Phase 3 study of CAPLYTA for bipolar I disorder, meeting primary and secondary endpoints. The study showed a 3.7-point greater reduction in YMRS scores compared to placebo. JNJ plans to submit these findings to the FDA for approval. CAPLYTA is already approved for schizophrenia and depression. JNJ stock closed at $282.11, up 2.13%.

Johnson & Johnson (JNJ) reported that CAPLYTA (lumateperone) met primary and secondary endpoints in a Phase 3 study for bipolar mania, showing significant improvement in symptoms by Day 3. The company plans a U.S. FDA submission based on these results and prior study data.

Johnson & Johnson's Phase 2 Sjögren’s disease study found dry mouth as the top symptom patients wanted improved. 49 of 163 participants completed exit interviews. Separately, 33% of nipocalimab recipients saw a 50% increase in salivary flow vs. 16% for placebo. Two Phase 3 trials are ongoing, with FDA Breakthrough Therapy and Fast Track designations granted.

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