Intra-Cellular’s Caplyta Achieves Second Phase III Success in Major Depressive Disorder Treatment

1. Second Phase III Success: Intra-Cellular Therapies' antipsychotic Caplyta (lumateperone) has achieved a second Phase III trial success in treating major depressive disorder (MDD) as an adjunctive therapy.
2. Trial Results: The 42 mg daily dose of Caplyta showed a 4.5-point reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo at week 6, meeting the primary endpoint.
3. Consistency with Previous Study: The results are consistent with the first Phase III study (Study 501), which demonstrated a 4.9-point MADRS reduction versus placebo.
4. Secondary Objectives Met: The trial also met its secondary objectives, including a statistically significant change on the Clinical Global Impression Scale for Severity of Illness (CGI-S).
5. Market Potential: Analysts project that Caplyta could bring an additional $1 billion to $1.7 billion in peak sales by 2033 if approved for MDD, potentially reaching total U.S. sales of over $3 billion.
6. FDA Submission: Intra-Cellular plans to submit a supplemental New Drug Application (sNDA) for MDD in the second half of 2024.
7. Competitive Landscape: Caplyta's results position it competitively against AbbVie's Vraylar, which was approved for MDD 18 months ago.
8. Financial Impact: Intra-Cellular's share price jumped by 11% following the announcement, reflecting the significant market potential of Caplyta in MDD treatment.