Applied Clinical Trials Online

FDA Approves Caplyta as Adjunctive Therapy for Major Depressive Disorder Based on Positive Phase III Results

Caplyta’s most recent FDA approval is based on positive results from two Phase III clinical trials: Study 501 (NCT04985942) and Study 502 (NCT05061706). Both studies met their primary endpoint and key ...
The American Journal of Managed Care

FDA Approves Lumateperone as Add-On Therapy for Major Depressive Disorder

Lumateperone is approved as an adjunctive treatment for MDD, expanding its indications beyond schizophrenia and bipolar ...
Medical Dialogues

FDA Approves Lumateperone for Major Depressive Disorder

The FDA has approved lumateperone (Caplyta) as an adjunctive therapy with antidepressants for treating major depressive ...
The Malaysian Reserve

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 ...

Evoke Pharma Enters into Definitive Agreement to Be Acquired by QOL Medical

QOL Medical to Acquire All Outstanding Shares of Evoke for $11.00 Per Share in CashRepresents a 139.7% premium to most recent ...
MPR

FDA Greenlights Caplyta for Adjunctive Use in MDD

The Food and Drug Administration (FDA) has approved Caplyta ® (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.