Positive topline results reported from Study ‘402, a Phase 3 Study evaluating lumateperone as an adjunctive treatment to lithium or valproate in patients with bipolar depression.
Company is preparing sNDA for the treatment of bipolar depression for submission to the FDA. Study ‘402, in conjunction with our previously reported positive Phase 3 monotherapy study, Study 404, forms the basis for our sNDA.
Strong CAPLYTA commercial performance with week-over-week and quarter-over-quarter prescription growth despite COVID-19 disruptions.
Expanding lumateperone development in Major Depressive Disorder (MDD) and other depressive disorders and advancing a Long-Acting Injectable (LAI) formulation:
A post-hoc analysis of Study ‘404, our global Phase 3 study in bipolar depression, demonstrated that lumateperone was effective in the subset of patients presenting with mixed features in bipolar depression (p=0.003).
Study ‘403 has been amended to evaluate lumateperone in patients with Bipolar depression and MDD with mixed features.
Commencing two Phase 3 clinical studies evaluating lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD.
Following discussions with the FDA, initiating clinical studies of our lumateperone LAI subcutaneous formulation.
#ICPT " announced its financial results for the third quarter ended September 30, 2020, and provided a corporate update".
See our ICPT AmpCards HERE.