JNJ - Intra-Cellular: More Upside Possible Even After Positive MDD Treatment Data

2024-04-16 13:17:12 ET

Summary

• Intra-Cellular Therapies, Inc. achieved positive results from Study 501, using lumateperone as an adjunctive therapy for the treatment of patients with MDD; Both primary and secondary endpoints achieved with statistical significance.
• The Major Depressive Disorder market across the eight major markets is expected to reach $9.6 billion by 2029.
• Results from the second phase 3 study using lumateperone as an adjunctive therapy for MDD, Study 502, are expected to be released in Q2 of 2024.
• With two positive phase 3 studies achieved, there is the potential for submission of New Drug Application of lumateperone to the FDA for the treatment of patients with MDD in the 2nd half of 2024.

Intra-Cellular Therapies, Inc. ( ITCI ) just reported positive results from one of its phase 3 studies using lumateperone as an adjunctive therapy to antidepressants for the treatment of patients with major depressive disorder [MDD]. This drug has already been approved by the FDA for the treatment of patients with schizophrenia and depressive episodes associated with bipolar I or bipolar II disorder as a monotherapy and as an adjunctive therapy with lithium or valproate....

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