J&J Finalizes Intra-Cellular Therapies Acquisition, Strengthens Neuroscience Leadership
Johnson & Johnson (NYSE: JNJ) has officially completed its acquisition of Intra-Cellular Therapies, Inc., marking a significant expansion of its neuroscience portfolio. Intra-Cellular Therapies will now operate as a business unit within Johnson & Johnson Innovative Medicine, reinforcing the company’s commitment to advancing treatments for neuropsychiatric and neurodegenerative disorders.
Joaquin Duato, Chairman and Chief Executive Officer of Johnson & Johnson, expressed enthusiasm about the acquisition, stating, “At,J&J we are committed to transforming care for the millions of people worldwide living with neuropsychiatric and neurodegenerative disorders. We are excited to officially welcome the talented Intra-Cellular Therapies team to the Company, and we look forward to working together as we realize our ambition of becoming the number one neuroscience company worldwide.”
The acquisition grants Johnson & Johnson ownership of CAPLYTA® (lumateperone), a once-daily oral therapy currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults. Additionally, CAPLYTA® is the first and only FDA-approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression), available both as a monotherapy and as an adjunctive therapy with lithium or valproate.
In February 2025, Intra-Cellular Therapies announced the FDA’s acceptance of a supplemental new drug application (sNDA) for CAPLYTA® as an adjunctive treatment for adults with major depressive disorder (MDD), further expanding its potential reach in mental health care. Additionally, the acquisition includes ITI-1284, an investigational Phase 2 compound currently being studied for generalized anxiety disorder (GAD) and Alzheimer’s disease-related psychosis and agitation, as well as a robust clinical-stage pipeline that complements Johnson & Johnson’s existing neuroscience portfolio.
Jennifer Taubert, Executive Vice President and Worldwide Chairman of Innovative Medicine at J&J, emphasized the strategic importance of the acquisition. “We are focused on investing in what we believe is the future of innovation across our targeted therapeutic areas, including neuroscience. We are pleased to finalize this acquisition, which serves as a strategic near- and long-term growth catalyst for Johnson & Johnson, and we look forward J&J to working together to continue transforming treatment and patient care for some of today’s most debilitating neuropsychiatric and neurodegenerative disorders.”
From a financial perspective, J&J expects the transaction to drive a significant boost to its 2025 sales growth. The company anticipates an approximate 0.8% increase in sales, equating to approximately $0.7 billion in incremental revenue. Despite J&J the anticipated dilution of adjusted earnings per share (EPS) by approximately $0.25 in 2025, the company has revised its earlier estimate of $0.30 to $0.35, improving its financial outlook. By 2026, earnings dilution is projected to be further reduced to approximately $0.21 per share, as financing costs are partially offset by operational synergies. Johnson & Johnson will provide further details in its full-year 2025 financial outlook during its first-quarter earnings report on April 15, 2025.
Following the completion of the acquisition, Intra-Cellular Therapies’ common stock has ceased trading on the NASDAQ Global Select Market, reflecting its integration into J&J’s corporate structure.
Indications and Safety Information for CAPLYTA® (lumateperone)
CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as both monotherapy and adjunctive therapy with lithium or valproate.
Boxed Warnings:
- Increased Risk of Death in Elderly Patients with Dementia-Related Psychosis: Antipsychotic drugs, including CAPLYTA®, are associated with an increased risk of death in elderly patients with dementia-related psychosis. CAPLYTA® is not approved for the treatment of dementia-related psychosis.
- Suicidal Thoughts and Behaviors: Antidepressants have been linked to an increased risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. All patients treated with antidepressants J&J should be closely monitored for clinical worsening and emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA® have not been established in pediatric patients.
Contraindications:
- CAPLYTA® is contraindicated in patients with known hypersensitivity to lumateperone or any of its components. Reported reactions have included pruritus, rash (allergic dermatitis, papular rash, generalized rash), and urticaria.
Warnings & Precautions:
- Cerebrovascular Adverse Reactions: Elderly patients with dementia-related psychosis have an increased risk of stroke and transient ischemic attack.
- Neuroleptic Malignant Syndrome (NMS): A potentially fatal reaction characterized by high fever, stiff muscles, confusion, autonomic instability, elevated creatinine phosphokinase, myoglobinuria, and acute renal failure. Immediate medical intervention is required.
- Tardive Dyskinesia (TD): A condition involving involuntary movements, particularly of the face and tongue. Symptoms may not resolve after discontinuation of CAPLYTA®.
- Metabolic Changes: Hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain have been observed. Patients should undergo periodic monitoring of weight, plasma glucose, and lipid levels.
- Leukopenia, Neutropenia, and Agranulocytosis: Complete blood counts should be conducted for patients with pre-existing low white blood cell counts or a history of blood disorders. CAPLYTA® should be discontinued if a significantJ&J decline in WBC occurs.
- Orthostatic Hypotension & Falls: Patients may experience dizziness or lightheadedness upon standing. Monitoring of blood pressure is advised, especially in patients with cardiovascular conditions.
- Seizures: CAPLYTA® should be used cautiously in patients with a history of seizures.
- Cognitive and Motor Impairment: Patients should exercise caution when operating machinery or driving until they understand how CAPLYTA® affects them.
- Body Temperature Dysregulation: Use with caution in conditions that may increase body temperature, such as strenuous exercise, extreme heat, or dehydration.
- Dysphagia: Patients at risk for aspiration should be monitored closely.
Drug Interactions:
- CAPLYTA® should not be used with CYP3A4 inducers. Dose adjustments are recommended when used with strong or moderate CYP3A4 inhibitors.
Special Populations:
- Pregnancy: Newborns exposed to antipsychotics during the third trimester are at risk of withdrawal symptoms and extrapyramidal symptoms post-delivery.
- Hepatic Impairment: Dose reduction is recommended for patients with moderate or severe hepatic impairment.
Adverse Reactions:
- The most common side effects observed in clinical trials included somnolence/sedation, dizziness, nausea, and dry mouth.
The acquisition of Intra-Cellular Therapies represents a strategic move by Johnson & Johnson to bolster its neuroscience portfolio and solidify its leadership in J&J neuropsychiatric treatment. With CAPLYTA® and a promising pipeline of investigational therapies, J&J is well-positioned to drive innovation in mental health care while achieving long-term growth in the pharmaceutical sector.
