Morningstar

FDA approves CAPLYTA® (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia

TITUSVILLE, N.J., April 27, 2026 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on ...
NJBIZ

FDA approves J&J’s Caplyta as add-on depression drug

The U.S. Food and Drug Administration has approved the expanded use of Johnson & Johnson‘s Caplyta as an add-on treatment for adults with major depressive disorder. Following the FDA’s Nov. 5 decision ...
Healio

FDA approves Caplyta as adjunctive therapy in adults with major depressive disorder

Please provide your email address to receive an email when new articles are posted on . Caplyta had been previously approved by FDA for bipolar I and II depression and schizophrenia. Approval was ...
Pharm Exec

FDA Approves Caplyta for Prevention of Schizophrenia in Adults

FDA label expansion adds relapse-prevention in adult schizophrenia, addressing a major driver of hospitalization, functional deterioration, and caregiver burden in chronic disease management. A Phase ...

CAPLYTA Data Highlights Johnson & Johnson Valuation And Mental Health Story

Johnson & Johnson's CAPLYTA (lumateperone) showed superior efficacy and favorable safety in major depressive disorder in a new network meta-analysis. The study compared CAPLYTA to other FDA approved ...
Morningstar

CAPLYTA® (lumateperone) showed greatest improvement across key efficacy outcomes among adjunctive MDD treatments in new network meta-analysis

CAPLYTA® ranked highest among FDA-approved adjunctive therapies across four measures of efficacy, based on indirect comparisons from placebo plus antidepressant therapy-controlled trials Among the ...
abc27

FDA approval of CAPLYTA® (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder

TITUSVILLE, N.J., Nov. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved CAPLYTA ® (lumateperone) as an adjunctive therapy ...
STAT

FDA approves J&J’s antipsychotic drug to treat depression

Damian covers the global drug industry and contributes to STAT’s industry-leading events. You can reach Damian on Signal at damiangarde.67. Johnson & Johnson won U.S. approval to sell the ...
Insider Monkey

Johnson & Johnson Submits Schizophrenia Drug CAPLYTA sNDA to FDA Based on Positive Relapse Prevention Data

Johnson & Johnson (NYSE:JNJ) is one of the most undervalued NYSE stocks to buy now. On July 8, Johnson & Johnson announced the submission of a supplemental New Drug Application/sNDA to the US FDA for ...
FiercePharma

Another Caplyta trial win moves Intra-Cellular closer to FDA filing in major depressive disorder

Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug. In what CEO ...
Nasdaq

Intra-Cellular Therapies Submits Supplemental New Drug Application (sNDA) to FDA for CAPLYTA® (lumateperone) for the Treatment of Major Depressive Disorder as Adjunctive Therapy

BEDMINSTER, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for ...