Johnson & Johnson Stock Price, News & Analysis

Johnson & Johnson (NYSE: JNJ) announced positive results from the Phase 3b APEX study of TREMFYA® (guselkumab) in treating active psoriatic arthritis (PsA). The study met its primary endpoint of reducing signs and symptoms (ACR20) and major secondary endpoint of reducing structural damage progression at 24 weeks compared to placebo.

TREMFYA® stands as the first and only fully-human, dual-acting monoclonal antibody approved for PsA that blocks IL-23 while binding to CD64. The drug demonstrated significantly less progression of structural damage versus placebo at Week 24, measured by the PsA modified van der Heijde-Sharp (vdH-S) score. The safety profile remained consistent with previous findings, with no new safety signals identified.

The APEX study includes a long-term extension through three years to assess sustained efficacy in structural damage inhibition, with results pending presentation at upcoming medical congresses.

Johnson & Johnson (NYSE: JNJ) has completed its acquisition of Intra-Cellular Therapies, adding CAPLYTA® (lumateperone) to its neuroscience portfolio. CAPLYTA® is the first and only FDA-approved treatment for bipolar I and II depression and is also approved for adult schizophrenia treatment.

The acquisition is expected to boost JNJ's 2025 sales growth by approximately 0.8% with $0.7 billion in incremental sales. The transaction will dilute adjusted EPS by approximately $0.25 in 2025, improving from the initially estimated $0.30-$0.35, and reduce to $0.21 per share in 2026.

The deal strengthens JNJ's therapy lineup with $5 billion+ potential in peak year sales. Additionally, JNJ gains ITI-1284, a Phase 2 compound being studied for generalized anxiety disorder and Alzheimer's disease-related psychosis and agitation.

Johnson & Johnson (NYSE: JNJ) has announced plans to complete its acquisition of Intra-Cellular Therapies around April 2, 2025, following shareholder approval on March 27, 2025. The transaction is projected to boost JNJ's 2025 sales growth by 0.8%, adding approximately $0.7 billion in incremental sales.

The acquisition is expected to dilute adjusted earnings per share (EPS) by $0.25 in 2025, an improvement from the previously estimated $0.30-$0.35 dilution. For 2026, earnings dilution is anticipated to decrease to $0.21 per share as operational accretion partially offsets annualized financing costs. JNJ will incorporate these estimates into its full-year 2025 financial outlook during first quarter results announcement on April 15, 2025. Following the acquisition, Intra-Cellular Therapies will delist from NASDAQ.

Johnson & Johnson (NYSE:JNJ) faced a significant legal setback as U.S. Bankruptcy Court Judge Christopher Lopez rejected the company's third bankruptcy attempt to shield itself from talcum powder liability claims. The ruling enables thousands of ovarian cancer patients to pursue their cases in trial courts and through multidistrict litigation.

Despite having a market capitalization of approximately $400 billion, J&J attempted to use bankruptcy protection through different company names (LTL, LLT, and Red River) to force victims into what plaintiffs' attorneys described as an inadequate settlement. The company had previously discontinued talc-based powder sales in North America in 2020 and globally in 2023.

The legal proceedings will now move to trial courts and juries, including the MDL in New Jersey federal court and state courts, where claimants will pursue bellwether trials to establish liability and compensation for allegations that J&J's talc-based Baby Powder and Shower to Shower products caused ovarian cancer in thousands of women.

Johnson & Johnson (NYSE:JNJ) announced groundbreaking results from the Phase 3 MARIPOSA study, showing that RYBREVANT® plus LAZCLUZE™ significantly extended overall survival in first-line treatment of EGFR-mutated non-small cell lung cancer compared to osimertinib.

Key findings at 37.8 months median follow-up include:

• Median overall survival not yet reached for RYBREVANT®/LAZCLUZE™ combination
• 56% survival rate at 3.5 years vs 44% for osimertinib
• Projected survival benefit exceeding 12 months compared to osimertinib's 36.7 months
• Time to symptomatic progression extended by 14+ months (43.6 vs 29.3 months)

The safety profile remained consistent with previous analyses, with most adverse events occurring early in treatment. The combination therapy is already approved in the US, Europe, and other markets for first-line EGFR-mutated NSCLC treatment.

Johnson & Johnson (NYSE: JNJ) presented significant new data for nipocalimab in treating generalized myasthenia gravis (gMG) at the 2025 AAN Annual Meeting. The presentations include results from the Phase 3 Vivacity-MG3 study, showing sustained disease control through nipocalimab treatment in antibody-positive adult patients.

Key highlights include:

• Significant improvement in muscle strength demonstrated through QMGa assessment scores
• Long-term efficacy and safety data from the ongoing open-label extension study
• Real-world evidence highlighting unmet needs in gMG treatment during pregnancy
• Studies examining oral corticosteroid exposure in MG

Notably, nipocalimab received FDA Priority Review following the August 2024 Biologics License Application (BLA) submission. The drug stands as the only investigational treatment with published data and ongoing Phase 3 studies in pregnant women at risk of alloantibody conditions.

Johnson & Johnson (NYSE: JNJ) has announced plans to invest more than $55 billion in U.S. manufacturing, R&D, and technology over the next four years, marking a 25% increase compared to the previous four-year period.

The investment includes the construction of four new manufacturing facilities, starting with a groundbreaking in North Carolina for a $2 billion+ biologics facility. The 500,000 square foot North Carolina site will support approximately 5,000 construction jobs, create over 500 permanent positions, and generate a $3 billion impact across the state in its first decade of operations.

The comprehensive investment plan encompasses:

• Three additional advanced manufacturing facilities and expansion of existing sites
• R&D infrastructure development for treatments in oncology, neuroscience, immunology, cardiovascular disease, and robotic surgery
• Enhanced technology investments for drug discovery and development

Johnson & Johnson (NYSE: JNJ) has received FDA approval for TREMFYA® (guselkumab) to treat adults with moderately to severely active Crohn's disease. This marks TREMFYA's fourth indication in the U.S., following previous approvals for plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

TREMFYA is the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options. The approval is supported by Phase 3 trials involving over 1,300 patients, where TREMFYA demonstrated superiority over STELARA® in all pooled endoscopic endpoints.

The recommended dosing includes SC induction at 400mg at Weeks 0, 4, and 8, or IV induction at 200mg for the same schedule. Maintenance dosing options are 100mg SC every 8 weeks or 200mg SC every 4 weeks. The company offers patient support through the TREMFYA® withMe program, enabling eligible commercially insured patients to receive their first induction treatment within 24 hours.

Johnson & Johnson (NYSE:JNJ) announced groundbreaking results for its lung cancer treatment combination at ELCC 2025. The Phase 3 MARIPOSA study demonstrated that RYBREVANT® plus LAZCLUZE™ significantly improved overall survival compared to osimertinib in first-line treatment of EGFR-mutated non-small cell lung cancer (NSCLC).

The median overall survival improvement is projected to exceed one year, marking a statistically superior result. The company also presented positive data from the Phase 2 COCOON study, which evaluated a prophylactic dermatologic regimen for patients receiving the RYBREVANT® combination.

Additional presentations included results from:

• Phase 2 PALOMA-2 study on switching to subcutaneous amivantamab
• CHRYSALIS-2 study comparing the combination therapy to EGFR TKI monotherapy
• Phase 1 study of JNJ-1900 (NBTXR3) radioenhancer with anti-PD1 treatment