Johnson & Johnson Submits sNDA for CAPLYTA®: A Major Step in Schizophrenia Relapse Prevention

TITUSVILLE, N.J. – July 8, 2025 – Johnson & Johnson (NYSE: JNJ) today announced a significant milestone in its commitment to mental health, with the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA). This submission is based on robust, long-term Phase 3 data demonstrating the efficacy and safety of CAPLYTA® (lumateperone) for the prevention of relapse in adults with schizophrenia. The data highlights a remarkable 63 percent reduction in the risk of relapse compared to placebo, underscoring CAPLYTA®'s potential to significantly improve patient outcomes.

Expanding Treatment Horizons for Schizophrenia

CAPLYTA®, developed by Intra-Cellular Therapies and now part of Johnson & Johnson's expanding neuroscience portfolio, is already FDA-approved for the treatment of schizophrenia and is the first and only approved treatment for bipolar I and II depression as both an adjunctive and monotherapy. The potential approval of this sNDA would further solidify CAPLYTA®'s role as a cornerstone therapy in managing complex psychiatric conditions. This strategic addition to Johnson & Johnson's robust portfolio of therapies means the company now offers the broadest range of treatment options for adults with schizophrenia, reinforcing its leadership in neuroscience.

Schizophrenia is a chronic and severe mental disorder affecting millions worldwide, characterized by profound disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. Relapse prevention is a critical aspect of long-term management, as each relapse can lead to further functional decline and increased burden on patients, caregivers, and healthcare systems. The 63% reduction in relapse risk observed in the Phase 3 study is a compelling indicator of CAPLYTA®'s potential to offer a more stable and predictable course of illness for patients.

Clinical Data and Market Impact

The sNDA submission is a direct result of comprehensive long-term Phase 3 clinical trials that rigorously evaluated CAPLYTA®'s ability to prevent relapse. These studies involved a diverse patient population and meticulously tracked key endpoints related to relapse rates, safety, and tolerability. The positive outcomes from these trials provide strong evidence supporting CAPLYTA®'s therapeutic value in this critical indication.

From a market perspective, the potential approval of CAPLYTA® for relapse prevention would address a significant unmet medical need. While existing treatments manage acute symptoms, long-term relapse prevention remains a challenge. A therapy that can substantially reduce relapse rates offers immense value to patients, healthcare providers, and payers. This could translate into reduced hospitalizations, improved quality of life, and lower overall healthcare costs associated with managing recurrent episodes of schizophrenia.

Investment Insights for JNJ Shareholders

For investors, this sNDA submission represents a positive development for Johnson & Johnson. The expansion of CAPLYTA®'s label to include relapse prevention for schizophrenia would enhance its market potential and revenue streams. As a diversified healthcare giant, JNJ's pharmaceutical segment is a key growth driver, and new indications for established or recently acquired drugs contribute significantly to this growth.

This move reinforces JNJ's commitment to innovation in neuroscience, a therapeutic area with high unmet needs and significant market opportunities. The successful integration of CAPLYTA® into JNJ's portfolio, coupled with this sNDA, demonstrates effective pipeline management and strategic acquisitions. Investors should view this as a positive signal regarding JNJ's long-term pharmaceutical growth trajectory and its ability to leverage its extensive commercial infrastructure to maximize the reach of its therapies. Continued monitoring of the FDA's review process and subsequent commercialization efforts will be crucial for assessing the full financial impact.

Looking Ahead

The FDA's review process for sNDAs typically involves a thorough evaluation of the submitted data. Johnson & Johnson will work closely with the agency to facilitate a timely review. A positive decision would not only benefit patients but also further strengthen JNJ's position as a leader in mental health therapeutics, contributing to its sustained growth and market leadership.