Caplyta Achieves Significant Victory in Major Depressive Disorder Trial, Paving Way for Competition with Vraylar

1. Caplyta's Success: Intra-Cellular Therapies' antipsychotic medication Caplyta (lumateperone) has demonstrated significant efficacy in a Phase III trial (Study 502) as an adjunctive treatment for major depressive disorder (MDD), achieving a 4.5-point reduction on the Montgomery-Asberg Depression Rating Scale (MADRS) compared to placebo.
2. Competition with Vraylar: The success of Caplyta sets up future competition with AbbVie's Vraylar (cariprazine), which was approved by the FDA as an adjunctive treatment for MDD in 2022.
3. Phase III Results: Study 502, a double-blind, randomized, placebo-controlled trial, enrolled 480 patients and showed Caplyta's efficacy and safety as a supplementary treatment for MDD patients. The results were consistent with those from Study 501, which reported a 4.9-point reduction in MADRS compared to placebo.
4. Market Potential: Caplyta is projected to generate nearly $3 billion in sales by 2030, representing a significant increase from the $918 million forecast for 2025.
5. FDA Submission: Intra-Cellular Therapies plans to submit a supplemental New Drug Application (sNDA) for Caplyta as an adjunctive therapy for MDD in the second half of 2024.
6. Share Price Surge: Following the announcement, Intra-Cellular's share price experienced a significant surge of 10.5%.