Intra-Cellular Therapies
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2002-01-01
- Employees
- 610
- Market Cap
- $7.8B
- Introduction
Intra-Cellular Therapies, Inc. operates as a biopharmaceutical company. It focuses on the discovery and clinical development of small molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system, or CNS. The firm’s lead product candidate, ITI-007, is in clinical development as a first-in-class treatment for schizophrenia. It also includes pre-clinical programs that are focused on advancing drug candidates for the treatment of cognitive dysfunction, in both schizophrenia and Alzheimer's disease and for disease modification and the treatment of neurodegenerative disorders, including Alzheimer's disease. The company was founded by Paul Greengard and Sharon Mates in 2002 and is headquartered in New York, NY.
How Intra-Cellular surprised Wall Street by breaking character
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.
Four investment experts identify eight healthcare investments beyond obesity drugs
Innovations in obesity, ovarian cancer vaccines, Alzheimer’s, and mental health drugs are transforming healthcare, with UK tech stocks and biotech sectors offering untapped investment opportunities. Key players include Intra-Cellular Therapies, Supernus Pharmaceuticals, and specialist providers like Bioventix and Diaceutics. Funds like Comgest Growth Europe ex UK and Polar Capital Global Healthcare Trust offer diversified healthcare exposure.
Lumateperone Demonstrates Positive Efficacy for Schizophrenia Relapse Prevention
Lumateperone (Caplyta) showed significant efficacy in preventing relapse in schizophrenia patients in Study 304, with a 63% reduction in relapse risk compared to placebo. The treatment was well-tolerated, with headache being the most common adverse event.
Phase 3 Data Shows Lumateperone Delays Schizophrenia Relapse Longer Than Placebo
Study 304 showed lumateperone (CAPLYTA) 42 mg significantly delayed relapse in schizophrenia patients compared to placebo, with a 63% reduction in relapse risk. Lumateperone, an atypical antipsychotic, is approved for schizophrenia and bipolar disorder, mediated through central serotonin 5-HT2A and dopamine D2 receptors. The trial's positive results support long-term treatment efficacy and safety.
Positive Phase 3 Results Evaluating Lumateperone for the Prevention of Relapse in Schizophrenia
Intra-Cellular Therapies announced positive results from study 304, showing lumateperone (Caplyta) 42 mg effectively prevents relapse in schizophrenia patients, with a 63% reduction in relapse risk compared to placebo. Lumateperone was generally safe and well-tolerated, with a primary endpoint of longer time to first symptom relapse and a secondary endpoint of better treatment discontinuation rates.
Lumateperone Demonstrates Efficacy in Reducing Symptomatic Relapse Risk in Schizophrenia
Intra-Cellular Therapies reports positive results from a study on 42 mg lumateperone (Caplyta) for relapse prevention in schizophrenia. The study showed significant reduction in relapse risk (HR, 0.37; 95% CI, 0.22-0.65) and better safety compared to placebo. Lumateperone is FDA-approved for schizophrenia and bipolar depression.
Intra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for Schizophrenia Maintenance Treatment
CAPLYTA (lumateperone) demonstrated efficacy and safety as a maintenance treatment for schizophrenia in a randomized withdrawal trial, showing a statistically significant longer time to relapse compared to placebo (p=0.0002).
CAPLYTA Shows Breakthrough 63% Reduction in Schizophrenia Relapse Risk
Intra-Cellular Therapies announced positive Phase 3 results for CAPLYTA (lumateperone) in preventing schizophrenia relapse, showing a 63% reduction in relapse risk vs. placebo (p=0.0002), with 16.4% of lumateperone patients relapsing vs. 38.6% in the placebo group. The drug was generally well-tolerated, with headache as the most common adverse event.
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