Lumateperone news

24 abstracts at Psych Congress will report Phase 3 CAPLYTA data in bipolar mania, SPRAVATO analyses on anhedonia, seltorexant MDD+insomnia results, and LAI real‑world studies.

Quarterly sales topped $25.3B; adjusted net earnings and EPS rose, free cash flow improved, and full-year revenue guidance was raised above $100B for the first time.

Network meta-analysis of 10 trials found an adjunctive atypical antipsychotic superior on MADRS change, response, remission and CGI‑S, with no significant weight gain and favorable tolerability.

FDA approved sNDA for CAPLYTA (lumateperone) to prevent relapse in schizophrenia. Phase 3 randomized‑withdrawal: 63% lower relapse risk (HR 0.37); 84% relapse‑free at 6 months; safety consistent.

CAPLYTA® nearly doubles remission rates in major depressive disorder when used with antidepressants, showing sustained benefits over six months in clinical studies.

11 abstracts on neuropsychiatry, including MDD and TRD, will be presented, highlighting clinical and preclinical research, AI tools, and novel therapeutic mechanisms.

FDA approves CAPLYTA® as adjunctive therapy for major depressive disorder, showing significant symptom improvement and safety in trials, with potential for remission.