Johnson & Johnson Stock Price, News & Analysis

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.

Johnson & Johnson (NYSE: JNJ) reported Week 28 Phase 2b ANTHEM-UC results for icotrokinra in moderately to severely active ulcerative colitis on Oct 27, 2025.

Key outcomes at Week 28 for the 400 mg once-daily dose: clinical remission 31.7% vs placebo 9.5%, endoscopic improvement 38.1% vs placebo 11.1%, and clinical response 66.7% vs placebo 25.4%. All tested doses (100 mg, 200 mg, 400 mg) favored icotrokinra over placebo for response, remission, endoscopic and histologic-endoscopic mucosal improvement.

Adverse event and serious adverse event rates were reported as similar across icotrokinra and placebo through Week 28. Phase 3 programs (ICONIC-UC and ICONIC-CD) are underway; an NDA for plaque psoriasis was submitted in July 2025.

Johnson & Johnson (NYSE: JNJ) reported Phase 2 DAHLIAS results published in The Lancet showing nipocalimab significantly reduced Sjögren's disease activity at Week 24 versus placebo.

Key findings: ClinESSDAI LS mean difference –2.65 (90% CI –4.03 to –1.28; p=0.0018) for nipocalimab 15 mg/kg Q2W, biomarker declines including rheumatoid factor and circulating immune complexes, and objective salivary flow improvement in 33% vs. 16% of patients (15 mg/kg vs placebo). Safety was described as tolerable with no new signals, no increase in serious infections, and no participants requiring IVIG or rescue therapy. Nipocalimab holds Breakthrough Therapy Designation (Nov 2024) and Fast Track (Apr 2025); the Phase 3 DAFFODIL study is enrolling.

Johnson & Johnson (NYSE: JNJ) reported 52-week Phase 3 ICONIC-TOTAL results for icotrokinra, an investigational oral peptide targeting the IL-23 receptor, in adolescents and adults with plaque psoriasis at high-impact sites.

Key findings: 72% scalp ss-IGA 0/1, 85% genital sPGA-G 0/1, site-specific clearance durable to Week 52; overall IGA 0/1 was 67% at Week 24 and maintained at Week 52, with 44% achieving IGA 0. Hand/foot hf-PGA 0/1 rose from 42% at Week 16 to 62% at Week 52 in a smaller subset. Adverse event and serious adverse event rates through Week 52 were similar to Week 16 with no new safety signals identified.

Johnson & Johnson (NYSE: JNJ) will present at the 7th Annual Wolfe Research Healthcare Conference on Monday, November 17, 2025. Management will take part in a Fireside Chat at 10:40 a.m. Eastern Time. A live audio webcast will be available on the company’s Investor Relations website and an archived edition will be posted later that day.

The audio webcast replay is expected to be available approximately 48 hours after the webcast. Media and investor contact emails are provided for follow-up.