Welcome to our dedicated page for Johnson & Johnson news (Ticker: JNJ), a resource for investors and traders seeking the latest updates and insights on Johnson & Johnson stock.
Johnson & Johnson (NYSE: JNJ) generates a steady flow of news across Innovative Medicine and MedTech, reflecting its role in pharmaceutical preparation manufacturing and medical technologies. On this news page, readers can follow company announcements on clinical trial results, regulatory milestones, strategic transactions, manufacturing investments and corporate actions.
Recent oncology news includes positive topline data from the Phase 3 MajesTEC-9 study of TECVAYLI (teclistamab-cqyv) monotherapy in relapsed or refractory multiple myeloma, where Johnson & Johnson reported a substantial reduction in the risk of disease progression or death versus standard of care in a population predominantly refractory to anti-CD38 therapy and lenalidomide. The company has also shared longer-term results from the OrigAMI-1 study of RYBREVANT (amivantamab-vmjw) plus chemotherapy in metastatic colorectal cancer, supporting further Phase 3 evaluation of amivantamab-based regimens in first- and second-line settings.
In neuroscience and mental health, Johnson & Johnson has highlighted new data on CAPLYTA (lumateperone), SPRAVATO (esketamine) and the investigational agent seltorexant at major scientific meetings, including analyses focused on remission in major depressive disorder, treatment-resistant depression and sleep-related symptoms. The company has also announced positive Phase 2b results for nipocalimab in systemic lupus erythematosus and plans to initiate a Phase 3 program, underscoring its activity in autoantibody-driven diseases.
MedTech news covers developments such as the FDA submission of the OTTAVA robotic surgical system for De Novo classification, supported by an IDE study in gastric bypass procedures, and an expanded indication for the TRUFILL n‑BCA Liquid Embolic System for chronic subdural hematoma. Corporate and financial updates, including quarterly dividend declarations, U.S. manufacturing investments and government agreements to improve access to medicines, also appear in Johnson & Johnson’s news flow. Investors, clinicians and observers can use this page to monitor how Johnson & Johnson’s clinical, regulatory and strategic decisions evolve over time.
Johnson & Johnson (NYSE: JNJ) partnered with Naomi Watts on Dec. 3, 2025 to promote eye exams as part of self-care for people over 40. A new global survey found 82% of Americans say clear vision supports confidence, yet 48% of those over 40 who think they need vision correction haven't seen an eye care professional in the past year. The release highlights presbyopia (begins ~age 40), cataracts, and that an annual eye exam can detect 270+ health conditions. The campaign urges routine comprehensive eye exams, modern corrective options, and talking to a doctor to preserve vision and independence.
TREMFYA (guselkumab) received FDA approval for a subcutaneous (SC) induction regimen to treat adults with moderately to severely active ulcerative colitis (UC) on Sept. 19, 2025.
Approval follows Phase 3 ASTRO data showing SC induction (400 mg q4w) produced clinical remission 26% vs 7% and endoscopic improvement 36% vs 12% versus placebo at Week 12, with comparable efficacy to previously approved 200 mg IV induction. Week 24 SC maintenance rates included clinical remission 34% vs 10% and endoscopic improvement up to 44% vs 12%. The company also announced a head-to-head Crohn's disease study vs Skyrizi (risankizumab).
Johnson & Johnson (NYSE: JNJ) reported Phase 3b APEX data showing TREMFYA (guselkumab) significantly inhibited structural joint damage in active psoriatic arthritis through Week 48 and reduced radiographic progression by 57% for placebo-switch patients from Week 24–48 (mean vdH-S 0.96 to 0.41).
TREMFYA showed ~2.5x greater inhibition versus placebo at Week 24, sustained at Week 48, and more than half of treated patients across dose groups achieved ACR50 by Week 48. Safety was consistent with the established profile and no new signals were identified. JNJ submitted an sBLA to FDA to add inhibition-of-structural-damage data to the label.
Johnson & Johnson (NYSE: JNJ) agreed to acquire Halda Therapeutics OpCo for $3.05 billion in cash, announced November 17, 2025. The deal includes Halda’s RIPTAC™ platform and lead clinical candidate HLD-0915, a once-daily therapy in a Phase 1/2 trial for prostate cancer that showed preliminary efficacy and an early safety profile. The acquisition adds earlier assets for breast, lung and other solid tumors and is expected to close within the next few months, subject to antitrust clearance and customary conditions.
Johnson & Johnson (NYSE:JNJ) announced FDA approval (Nov 6, 2025) of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) as the first and only treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). The approval is based on the Phase 3 AQUILA trial, which showed DARZALEX FASPRO reduced the risk of progression to active multiple myeloma or death by 51% versus active monitoring (HR 0.49; 95% CI 0.36-0.67; P<0.001) after median 65.2 months follow-up.
Key results: 5-year non-progression 63.1% vs 40.7%; overall response rate 63.4% vs 2.0%; median time to first-line myeloma therapy not reached vs 50.2 months. Common adverse reactions ≥20% included respiratory infection, musculoskeletal pain, fatigue, diarrhea, rash, sleep disorder, sensory neuropathy, and injection site reactions.
Johnson & Johnson (NYSE: JNJ) announced FDA approval of CAPLYTA (lumateperone) on November 6, 2025 as an adjunctive treatment with oral antidepressants for adults with major depressive disorder (MDD).
Approval was supported by two Phase 3 trials (Study 501, 502) showing MADRS separation at 6 weeks (Study 501: -4.9 points, effect size 0.61; Study 502: -4.5 points, effect size 0.56) and a 26-week open-label study where 80% responded and 65% reached remission. Safety was consistent with prior indications; no meaningful mean weight, metabolic, or sexual side‑effect increases versus placebo. CAPLYTA starts at a single 42 mg dose without titration and is now the drug's fourth FDA indication.
Johnson & Johnson (NYSE: JNJ) will present at Citi’s 2025 Global Healthcare Conference on Wednesday, December 3, 2025. Management will participate in a Fireside Chat at 11:15 a.m. ET. A live audio webcast will be accessible via Johnson & Johnson’s Investor Relations website at www.investor.jnj.com. An archived edition will be available later the same day, and the audio webcast replay will be posted approximately 48 hours after the live session.
Johnson & Johnson (NYSE: JNJ) announced initiation of the EPIC Phase 3b study, the first head-to-head randomized, open-label trial comparing the FcRn blocker IMAAVY (nipocalimab) versus efgartigimod in adults with generalized myasthenia gravis (gMG), including a treatment-switch arm.
Separately, new Vibrance-MG Phase 2/3 long-term extension data in pediatric patients (≥12 years) showed a median ~73% IgG reduction by Week 24, sustained IgG reductions and sustained disease control through 72 weeks, functional and strength improvements, and no new safety concerns. IMAAVY is approved for adults and pediatric gMG (12+) in the U.S., Brazil and Japan, with additional regulatory submissions under review globally.
Johnson & Johnson (NYSE: JNJ) reported U.S. findings from the ENCOMPASS study (presented Oct 27, 2025) showing significant unmet need in psoriasis and a clear preference for effective oral therapies with favorable safety.
Key results: 50.5% of adults are eligible for systemic therapy; 50.5% of adult patients and 47.5% of dermatology providers prefer oral treatments; 91.2% of patients on injectables would switch to an equally effective oral option. Quality-of-life burden was high: 55% of adults and up to 77% of younger adolescents reported very large or extremely large impact.
Johnson & Johnson (NYSE: JNJ) reported 96-week LTE results from Phase 3 GRAVITI and GALAXI studies showing durable efficacy of TREMFYA (guselkumab) in adults with moderately to severely active Crohn's disease. At Week 96, clinical remission exceeded 85% across maintenance regimens (100 mg q8w and 200 mg q4w). Endoscopic remission and deep remission were sustained through two years, with pooled GALAXI endoscopic remission up to 56.6% and deep remission up to 51.2%. Safety through 96 weeks was consistent with TREMFYA's established profile. TREMFYA is approved for both SC and IV induction and for ulcerative colitis.