Neuroscience Insights

News, strategy, and signals in neurologic and neuropsychiatric care.

MDD TRD Bipolar mania Schizophrenia gMG

Vraylar (cariprazine) – Adjunctive Therapy in MDD Under FDA Review

Vraylar shows mixed efficacy in Phase 3 MDD trials; FDA decision on adjunctive use expected late 2025.

Seltorexant – Positive Phase 3 Results for MDD with Insomnia

Seltorexant shows robust efficacy in improving both depression and sleep in MDD; NDA expected in late 2025.

Spravato (esketamine) – FDA Approval for TRD Monotherapy

FDA approves Spravato for TRD monotherapy; first non-oral, fast-acting single-agent treatment in its class.

Caplyta (lumateperone) – Positive Phase 3 Results in Adjunctive MDD Treatment

Caplyta meets Phase 3 endpoints for adjunctive MDD treatment; sNDA expected in late 2025.

Rapid Disease Control Validated in AAN 2025 Presentation

AAN 2025 data confirm Vyvgart Hytrulo’s rapid, sustained benefits in gMG across flexible subcutaneous dosing schedules.

Imaavy Approved for Broad gMG Population

FDA approves Imaavy for gMG in adults and adolescents with AChR or MuSK antibodies—first FcRn inhibitor with pediatric coverage.

Caplyta Acquisition Broadens Neuroscience Platform

J&J finalizes acquisition of Caplyta’s developer, Intra-Cellular Therapies, advancing its neuropsychiatric strategy and pipeline.

Caplyta Filed for Schizophrenia Relapse Prevention

J&J files sNDA for Caplyta targeting schizophrenia relapse prevention; Phase III data shows 63% relapse risk reduction vs. placebo.