Intra-Cellular’s Caplyta Triumphs in Major Depressive Disorder Phase 3 Trial, Edging Closer to FDA Filing

1. Intra-Cellular Therapies' Caplyta (lumateperone) demonstrated statistically significant and clinically meaningful reductions in depressive symptoms in a Phase 3 trial for major depressive disorder (MDD).
2. The trial met its primary endpoint by showing a 4.9-point reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo at Week 6 (p<0.0001; Cohen’s d effect size (ES)= 0.61). 3. Caplyta also met the key secondary endpoint, with a statistically significant and clinically meaningful reduction in the Clinical Global Impression Scale for Severity of Illness (CGI-S) score compared to placebo at Week 6 (p<0.0001; ES= 0.67). 4. The drug showed statistically significant efficacy as early as Week 1, which is important for depression treatments. 5. Caplyta's safety and tolerability profile was consistent with its use in schizophrenia and bipolar depression. 6. Intra-Cellular Therapies is currently gathering data to request a meeting with the FDA and plans to discuss the next steps for the program. 7. The company projects Caplyta to reach peak sales of $4.3 billion, including $1.3 billion from a major depressive disorder indication. 8. Caplyta is currently approved for the treatment of schizophrenia and bipolar depression. 9. The Phase 3 test studied Caplyta as an adjunct to antidepressant therapy. 10. The drug's potential blockbuster status is based on its performance in both approved indications and the promising results in major depressive disorder. These findings suggest that Intra-Cellular Therapies is closer to an FDA filing for Caplyta's expanded indication in major depressive disorder.