Seeking Alpha

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 ...
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 ...
Yahoo Finance

Intra-Cellular Therapies Applies for FDA Approval of CAPLYTA® (lumateperone) for the Treatment of Bipolar Depression

ITCI submits Supplemental New Drug Applications (sNDAs) for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults. If ...
FOX59 News

Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo

Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA ® is FDA approved to treat schizophrenia ...
Stockhouse

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

The sNDA submission is based on positive results from Studies 501 and 502 demonstrating CAPLYTA’s robust antidepressant efficacy and favorable safety and tolerability profile CAPLYTA, ...
FiercePharma

Intra-Cellular nabs nod for schizophrenia drug Caplyta after FDA twists and turns

Intra-Cellular Therapies had quite a journey toward an FDA decision on its antipsychotic contender. It involved mixed clinical data, a canceled advisory committee meeting and a three-month review ...
Yahoo Finance

Intra-Cellular Therapies Announces FDA Acceptance of CAPLYTA® (lumateperone) sNDAs for the Treatment of Bipolar Depression

NEW YORK, May 03, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central ...
Healthline

Does Medicare Cover Caplyta?

Caplyta is a brand-name prescription medication containing the active ingredient lumateperone. Currently, no generic version of the medication is available. An important note about Caplyta for older ...
Nasdaq

FDA Approves Intra-Cellular Therapies’ Novel Antipsychotic, CAPLYTA® (lumateperone) for the Treatment of Schizophrenia in Adults

NEW YORK, Dec. 23, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) ...
Finanznachrichten

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

CAPLYTA ®, in combination with an oral antidepressant, demonstrated superior efficacy with a favorable safety and tolerability profile consistent with established indications 1,2 In pivotal trials, ...
Nasdaq

Intra-Cellular Therapies Announces FDA Acceptance of CAPLYTA® (lumateperone) sNDAs for the Treatment of Bipolar Depression

NEW YORK, May 03, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central ...