Johnson & Johnson (JNJ) Stock News

Johnson & Johnson (NYSE: JNJ) reported updated CARTITUDE-4 Phase 3 results showing durable, treatment-free remissions with CARVYKTI as early as second line for relapsed or refractory multiple myeloma. In the as-treated standard-risk subgroup, the 30-month progression-free survival (PFS) rate plateaued at 80.5% (95% CI, 67.2–88.8) after a single infusion (median follow-up 33.6 months).

Of 176 patients treated in second line, 59 had standard-risk cytogenetics; all 26 patients who were MRD-negative CR at 12 months remained progression-free at 30 months. Translational analyses linked earlier-line use to stronger immune fitness (increased baseline CD4+ naïve T cells), which correlated with longer PFS.

Johnson & Johnson (NYSE:JNJ) reported Cohort 4 results from the Phase 2b SunRISe-1 study showing the gemcitabine intravesical system produced a one-year disease-free survival (DFS) of 74.3% (95% CI, 59.2-84.6) in BCG-unresponsive, high-risk, papillary-only NMIBC patients.

At median follow-up of 15.9 months, one-year progression-free survival was 95.6% and overall survival was 98%. 92.3% of patients did not undergo radical cystectomy. Treatment was generally well tolerated, with mostly low-grade urinary side effects and no treatment-related deaths.

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.