BEDMINSTER, N.J. - Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company specializing in central nervous system (CNS) disorders, has announced positive outcomes from a recent study evaluating lumateperone as a maintenance treatment for adults with schizophrenia. The findings, derived from Study 304, a randomized withdrawal trial, revealed that lumateperone significantly extended the time to relapse for patients compared to a placebo.
Schizophrenia, a severe mental disorder marked by acute psychotic episodes, demands effective management to prevent symptom relapse and improve long-term patient outcomes. In the study, the primary endpoint was the duration until the first symptom relapse during the double-blind treatment phase. Patients treated with lumateperone experienced a longer time to relapse with a 63% reduction in the risk of relapse compared to those on placebo.
The trial included an open-label phase where participants received lumateperone 42 mg daily for 18 weeks. Those meeting stabilization criteria were then randomized to continue lumateperone or switch to a placebo. The study reported 18 relapses in the lumateperone group versus 44 in the placebo group.
Lumateperone also achieved the key secondary endpoint of time to all-cause discontinuation during the double-blind phase. The treatment was generally well-tolerated, with headache being the most commonly observed adverse event at a rate greater than or equal to 5% and twice the rate of placebo.
CAPLYTA (lumateperone) is currently approved for treating schizophrenia and depressive episodes associated with bipolar I or II disorder in adults, both as monotherapy and adjunctive therapy with lithium or valproate. The medication is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA.
The study's senior executives expressed satisfaction with the results, emphasizing the potential benefits of lumateperone for long-term treatment. This news is based on a press release statement and has not been independently verified. The efficacy of CAPLYTA in pediatric patients has not been established, and the drug carries boxed warnings for increased risk of death in elderly patients with dementia-related psychosis and for increased risk of suicidal thoughts and behaviors in pediatric and young adult patients.
Intra-Cellular Therapies continues to explore lumateperone for other psychiatric and neurological disorders, although it is not yet FDA-approved for these conditions. Investors and patients alike are watching closely as the company progresses with its clinical trials and regulatory submissions.
In other recent news, Intra-Cellular Therapies, Inc. has reported a substantial increase in Q3 2024 net sales of its flagship product, CAPLYTA, totaling $175.2 million, a 39% surge compared to the same quarter in the previous year. This robust growth has led the company to elevate its full-year 2024 net sales guidance to a range of $665 million to $685 million. Intra-Cellular's CEO, Sharon Mates, highlighted the effectiveness of CAPLYTA in treating major depressive disorder (MDD), with a supplemental New Drug Application (NDA) set to be filed within this quarter.
These developments follow the company's optimistic forecast of a long-term sales opportunity of $5 billion for CAPLYTA over the next decade. Intra-Cellular is also conducting studies for long-acting injectable (LAI) formulations of CAPLYTA, expecting to yield data throughout 2024. However, R&D expenses have increased to $66.8 million in Q3 2024 due to ongoing clinical programs.
Analysts at various firms have noted the company's strong financial position, with $1 billion in cash and investments as of September 30, 2024. They also pointed out the potential market for CAPLYTA in treating bipolar II depression and MDD. However, the impact of the new sales team is anticipated to be more significant in 2025 and beyond.
InvestingPro Insights
Intra-Cellular Therapies' (NASDAQ:ITCI) positive study results for lumateperone are reflected in the company's strong financial performance and market position. According to InvestingPro data, ITCI has demonstrated impressive revenue growth, with a 46.08% increase in the last twelve months as of Q3 2024. This growth aligns with the potential market expansion for CAPLYTA, their flagship product for schizophrenia and bipolar disorder treatment.
The company's robust financial health is evident from InvestingPro Tips, which indicate that ITCI holds more cash than debt on its balance sheet and its liquid assets exceed short-term obligations. This strong financial position provides the company with the flexibility to continue investing in research and development for lumateperone and other pipeline products.
Investor confidence in ITCI's potential is reflected in its stock performance. The company has seen a significant 56.7% price return over the past year, and it's currently trading near its 52-week high. This positive momentum suggests that the market is optimistic about the company's future prospects, including the potential for lumateperone as a maintenance treatment for schizophrenia.
It's worth noting that while ITCI shows promise, it's not yet profitable, with a negative operating income of $121.62 million in the last twelve months. However, eight analysts have revised their earnings upwards for the upcoming period, indicating growing optimism about the company's financial trajectory.
For investors seeking a more comprehensive analysis, InvestingPro offers 14 additional tips for ITCI, providing a deeper understanding of the company's financial health and market position.
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