Johnson & Johnson reports healthcare developments across its Innovative Medicine and MedTech businesses. News commonly covers clinical and scientific data in immunology, oncology, neurology and neuropsychiatry, including medicines and candidates such as CAPLYTA, TREMFYA, JNJ-4804, seltorexant and the INVEGA long-acting injectable schizophrenia portfolio.
Company updates also include medical technology programs such as the investigational OTTAVA robotic surgical system, product and patient-education initiatives, quarterly sales and earnings releases, dividend actions, investor presentations and governance or investor-relations appointments.
Edwards Lifesciences (EW) raised its full-year sales growth outlook to approximately 11.5% after reporting growth across its medical-device businesses. Third-quarter sales rose 10.5% to $1.72 billion; the outlook is on a constant currency basis. Adjusted earnings guidance increased to $2.97–$3.05 per share.
Vertex (VRTX) raised 2026 revenue guidance to $13.15–$13.25 billion, while Humana (HUM) raised adjusted earnings guidance to at least $9.50 per share despite an expected year-over-year decline. McKesson (MCK) raised fiscal 2027 adjusted earnings guidance to $45.60–$46.40 per diluted share. Johnson & Johnson (JNJ) received accelerated FDA approval for RYBREVANT FASPRO in previously treated head and neck cancer, excluding HPV-associated oropharyngeal cancer. Continued approval may depend on confirmation of clinical benefit in the ongoing Phase 3 OrigAMI-5 trial.
Johnson & Johnson (NYSE: JNJ) reported a 73% PSA response rate with investigational pasritamig plus JNJ-9401 in advanced prostate cancer. In the Phase 1 study's recommended-regimen group, 11 of 15 patients had reductions of at least 50% in prostate-specific antigen (PSA), a marker of prostate cancer activity. Seven patients (47%) had reductions of at least 90%; all seven remained on treatment for more than six months without disease progression.
No Grade 3 or higher treatment-related adverse events were reported at this regimen; three patients had mild inflammatory reactions. These preliminary findings require evaluation in a larger population. The combination is being evaluated in the ongoing Phase 3 KLK2-comPAS study.
Johnson & Johnson (NYSE: JNJ) announced new patient-experience findings from its Phase 2 DAHLIAS study of nipocalimab in Sjögren's disease. Mouth dryness was the improvement patients most often prioritized. Interviews covered 49 of 163 participants, remained blinded and pooled treatment groups; 73.5% of interview participants reported being satisfied or very satisfied with study treatment.
Previously reported results showed 33% receiving 15 mg/kg nipocalimab versus 16% receiving placebo achieved at least a 50% increase from baseline in saliva flow at Week 24, an exploratory endpoint. Phase 2 results also showed significantly reduced disease activity and severity. Two Phase 3 studies are ongoing, with DAFFODIL assessing disease activity and patient-valued outcomes. Nipocalimab has FDA Breakthrough Therapy and Fast Track designations for adults with moderate-to-severe Sjögren's disease.
Johnson & Johnson (JNJ) announced that ICOTYDE met the primary endpoint in a Phase 3 trial in adults with active psoriatic arthritis. In ICONIC-PsA 1, which enrolled patients not previously treated with biologic medicines, 58% receiving 200 mg achieved ACR20 versus 41% receiving placebo at Week 16. ACR20 measures at least 20% improvement in joint counts and other disease measures. ACR50 and ACR70 responses were numerically higher at 29% versus 16% and 13% versus 5%, respectively.
Among patients with qualifying skin involvement, 57% achieved clear or almost clear skin versus 14% with placebo; 37% achieved 90% improvement in psoriasis severity versus 6%. At Week 24, ICOTYDE responses reached 69% for ACR20, 40% for ACR50 and 18% for ACR70. No new safety signals were identified through Week 24. ICOTYDE is not approved for active psoriatic arthritis.
Johnson & Johnson (NYSE: JNJ) received FDA accelerated approval for RYBREVANT FASPRO as a single-agent treatment for certain advanced head and neck cancers. The indication covers adults with recurrent or metastatic head and neck squamous cell carcinoma progressing on or after platinum-based chemotherapy and an anti–PD–(L)1 antibody, excluding HPV-associated oropharyngeal cancer.
In the Phase 1b/2 OrigAMI-4 cohort of 102 previously treated adults, confirmed overall response rate was 42 percent (95 percent confidence interval, 32–52 percent); 56 percent of responders maintained responses for more than six months. Serious adverse reactions occurred in 39 percent of patients and fatal adverse reactions in 6 percent. Continued approval may depend on verification of clinical benefit in the ongoing Phase 3 OrigAMI-5 confirmatory trial. This is the drug's first approved indication beyond lung cancer.
Johnson & Johnson (JNJ) announced three clinical analyses reporting mortality outcomes with Impella heart pump support during high-risk coronary procedures. The real-world and observational data cover 1,379 patients undergoing high-risk percutaneous coronary intervention, a procedure to open narrowed heart arteries.
Among 279 European patients, all-cause mortality was 6.1% at 30 days and 7.9% at 180 days. A U.S. registry analysis of 522 patients found cardiovascular mortality of 3.4% at discharge. In 578 PROTECT III patients meeting CHIP-BCIS3 entry criteria, in-hospital all-cause mortality was 4.7%, versus an estimated approximately 8% in CHIP-BCIS3. These are comparisons across studies. The company anticipates results from the randomized PROTECT IV trial in 2027.
Johnson & Johnson (NYSE: JNJ) will host an Enterprise Business Review for the investment community on December 8, 2026.
Leaders will review the Innovative Medicine and MedTech businesses, their pipelines and long-term strategy. The program includes enterprise and financial overviews, product demonstrations and Q&A sessions. The live General Session starts at 8:30 a.m. ET, with the event concluding at approximately 3:45 p.m. ET.
Johnson & Johnson (JNJ) reported a 77% response rate for its investigational RYBREVANT FASPRO combination in first-line advanced head and neck cancer.
Phase 1b/2 OrigAMI-4 Cohort 5 tested subcutaneous amivantamab with pembrolizumab and up to six carboplatin cycles. Among 22 patients without HPV-associated oropharyngeal cancer, confirmed tumor responses occurred in 77%, including complete responses in 14%; 65% of responses remained ongoing at median follow-up of 10.6 months. One-year overall survival was 77%. The seven patients with HPV-associated oropharyngeal cancer had a 29% response rate.
Common adverse events included anemia (73%), hypoalbuminemia (63%), thrombocytopenia (63%) and stomatitis (57%). The first-line Phase 3 OrigAMI-5 study is ongoing. A separate application for later-line head and neck cancer is under FDA Priority Review.
Johnson & Johnson (NYSE:JNJ) reported a 75 percent tumor response rate with investigational JNJ-6143 in previously treated advanced prostate cancer.
In the Phase 1 study's 50-mg cohort, 12 of 16 patients with measurable disease had a confirmed complete or partial response. Among 38 patients receiving that once-daily dose, 77 percent achieved a confirmed reduction of at least 50 percent in prostate-specific antigen (PSA), a blood marker used to monitor prostate cancer; 48 percent had reductions of at least 90 percent. At analysis, 71 percent remained on treatment, with median follow-up of 5.6 months.
Most treatment-related adverse events were mild to moderate. Adverse events led to four dose interruptions, one dose reduction and one treatment discontinuation. The company plans further development of the 50-mg once-daily dose, including a Phase 2 study in metastatic prostate cancer.
Johnson & Johnson (NYSE: JNJ) announced that perioperative ERLEADA plus hormone therapy reduced recurrence or death risk by 62% versus surgery alone.
The randomized Phase 3 PROTEUS substudy enrolled 408 patients with high-risk localized or locally advanced prostate cancer. Apalutamide plus androgen deprivation therapy, which suppresses androgen hormones, was given before and after surgery. At median follow-up of 37.8 months, median event-free survival was not reached with the regimen versus 19.1 months with surgery alone; three-year rates were 63% versus 41.4%. Metastasis or death risk was numerically 51% lower, while subsequent-treatment risk was 71% lower. Grade 3 or 4 treatment-emergent adverse events occurred in 31% versus 22%; neither arm reported treatment-emergent deaths. Overall survival follow-up continues. The regimen is not approved for this setting.