Lumateperone

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Intra-Cellular Therapies submitted an sNDA to the FDA for lumateperone as an adjunctive therapy for MDD, with phase 3 studies showing significant symptom reduction. Supernus Pharmaceuticals presented phase 2a data on SPN-820, showing rapid depressive symptom reduction and decreased suicidal ideation. Teva announced phase 3 SOLARIS study results showing TEV-749 improved social functioning in schizophrenia patients. Intra-Cellular Therapies also reported lumateperone delayed relapse in schizophrenia patients. However, emraclidine did not show significant symptom reduction in phase 2 trials. A study found high-dose antipsychotic use increased mortality risk in schizophrenia patients, while high-dose antidepressants reduced it.

Intra-Cellular Therapies submitted an sNDA to the FDA for lumateperone (Caplyta) as adjunctive therapy for MDD in adults. Studies 501 and 502 showed Caplyta's efficacy and safety profile, with robust efficacy for MDD and favorable metabolic, weight, and movement disorder profiles.

Intra-Cellular Therapies submits sNDA to FDA for CAPLYTA as adjunctive therapy for MDD, based on positive results from Studies 501 and 502, showing robust efficacy and favorable safety profile. CAPLYTA, if approved, would treat over 30 million adult patients in the US for three major psychiatry indications.

Intra-Cellular Therapies submits supplemental New Drug Application to FDA for Caplyta as MDD treatment. Caplyta, an oral atypical antipsychotic, is currently approved for schizophrenia and bipolar disorder. Phase 3 trials showed significant improvement in depression symptoms for non-responders to other antidepressants. Common side effects are similar to placebo, with low rates of movement problems and minimal metabolic changes. Caplyta's market presence is growing, with net product sales increasing by 86% in 2023.

Intra-Cellular Therapies seeks FDA approval for Caplyta as an adjunct treatment for major depressive disorder (MDD), potentially expanding its market to over $1 billion. Caplyta, already approved for schizophrenia and bipolar disorder, saw Q3 sales of $175 million, with Q4 projections at least $193 million. The MDD submission is based on Phase III trials showing symptom improvement when paired with an antidepressant. Jefferies estimates a 90–95% approval likelihood, predicting a company valuation of $9–12 billion. Intra-Cellular is also exploring Caplyta for autism and developing ITI-214 for Parkinson’s and ITI-333 for opioid use.

Intra-Cellular Therapies submits sNDA to FDA for CAPLYTA as adjunctive therapy for MDD, based on positive results from Studies 501 and 502, showing robust efficacy and favorable safety profile.

Intra-Cellular Therapies submits sNDA to FDA for CAPLYTA as adjunctive therapy for MDD, based on positive results from Studies 501 and 502, showing robust efficacy and favorable safety profile.

Intra-Cellular Therapies surprised analysts by projecting $5 billion in annual sales for its brain-rebalancing drug Caplyta within the next decade. The company, which licensed the drug from Bristol Myers Squibb in 2005, has seen its stock price rise by 13% following the announcement. Caplyta, known scientifically as lumateperone, is already approved for schizophrenia and bipolar depression, with potential approval for major depressive disorder expected next year. Intra-Cellular plans to expand its sales force in anticipation of this approval.