Intra-Cellular’s Caplyta Shows Promising Results in Major Depressive Disorder Study

1. Intra-Cellular Therapies' drug Caplyta (lumateperone) demonstrated significant improvement in reducing depression severity as an adjunctive therapy for Major Depressive Disorder (MDD) in the phase 3 Study 501.
2. Caplyta led to an average 4.9-point reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo at Week 6.
3. The drug also showed a statistically significant reduction on the patient-reported Clinical Global Impression Scale.
4. Efficacy was observed as early as one week into the study, with benefits maintained throughout the primary and secondary endpoints.
5. Commonly reported adverse events for Caplyta included dry mouth, fatigue, and tremors, which were mostly mild to moderate and resolved within a short period.
6. Caplyta is currently approved for schizophrenia and bipolar depression, and a potential MDD approval could lead to at least $1 billion in additional peak sales.
7. Intra-Cellular Therapies plans to file for MDD with the FDA this year, pending the results of a third phase 3 trial, Study 502, expected by the end of June 2024.
8. If approved for MDD, Caplyta's eligible patient population will expand, potentially making it a blockbuster drug.
9. Intra-Cellular Therapies' stock price experienced a significant surge following the successful completion of the clinical trial for Caplyta in MDD.

These results suggest that Caplyta may have a promising future as a treatment option for patients with Major Depressive Disorder.