NYSE:JNJ

Post Image
Johnson & Johnson Falls 4.8% Despite Q3 Beat as MedTech Weakness and 2027 EPS Dilution Weigh on Shares

Johnson & Johnson (NYSE: JNJ) shares fell about 4.8% even as the company reported third-quarter operational sales growth of 6%, ahead of analyst expectations, and raised its full-year 2026 guidance.

Innovative Medicine remained the main growth engine, with operational sales up 7.9%. Oncology grew about 17%, while RYBREVANT sales increased 64% and TREMFYA surged 68%. SPRAVATO also delivered 36% growth, highlighting continued momentum across several of J&J’s key pharmaceutical franchises.

The weaker area was MedTech, where operational sales increased just 2.5% and management acknowledged that performance fell short of expectations. J&J specifically pointed to Cardiovascular and Surgery outside the U.S. as areas needing improvement, while ABIOMED continued to face pressure from physician selectivity.

J&J raised its 2026 operational sales growth outlook to 6.7%-7.1%, representing about $100.7 billion at the midpoint. Reported sales are expected to reach roughly $101.2 billion at the midpoint. Adjusted reported EPS guidance was tightened to $11.05-$11.15.

However, investors may be focusing more heavily on the company’s 2027 earnings outlook. Management said the Firefly Bio acquisition and Sail Biomedicines collaboration are expected to reduce full-year 2027 adjusted EPS by a combined $1.36 per share, a meaningful near-term earnings headwind despite their longer-term pipeline potential.

The quarter also included the previously announced $5.5 billion agreement to resolve ovarian talc litigation, subject to participation by at least 95% of remaining claimants. The charge is reflected in third-quarter GAAP results.

The 4.8% decline therefore appears to reflect a combination of softer-than-expected MedTech performance, especially in Cardiovascular and Surgery, and concern over substantial acquisition-related EPS dilution expected in 2027, outweighing the strong pharmaceutical growth and improved 2026 guidance.
Post Image
Johnson & Johnson Reports Two-Year ICOTYDE Data Showing Durable Skin Clearance in Plaque Psoriasis

Johnson & Johnson reported new two-year Phase 3 data for ICOTYDE, or icotrokinra, showing sustained skin clearance in patients with plaque psoriasis affecting difficult-to-treat areas including the scalp, genitals, hands and feet.

In the ICONIC-TOTAL study, 70% of ICOTYDE-treated patients achieved clear or almost clear skin at Week 112, up from 57% at Week 16. Complete clearance rates at Week 112 reached 60% for scalp psoriasis, 89% for genital psoriasis and 63% for psoriasis affecting the hands or feet.

Nail psoriasis also continued to improve over time, with the average improvement in the modified Nail Psoriasis Severity Index reaching 71% at Week 112.

Safety findings through two years remained consistent with ICOTYDE’s established safety profile, with no new safety signals identified.

ICOTYDE is a once-daily oral peptide designed to block the IL-23 receptor. It is approved in the U.S. for moderate-to-severe plaque psoriasis in adults and patients aged 12 and older who meet treatment criteria, and is also approved in Europe, Japan and China.

The long-term results strengthen Johnson & Johnson’s case for ICOTYDE as an oral systemic treatment option, particularly for patients with psoriasis affecting sensitive or highly visible areas where treatment can be especially challenging.
Post Image
Johnson & Johnson Highlights Two-Year IMAAVY Data Showing Sustained Disease Control in gMG

Johnson & Johnson reported new two-year data for IMAAVY in generalized myasthenia gravis, showing sustained improvements in daily function and muscle strength among adolescents treated in the Phase 2/3 Vibrance-MG study.

At Week 108, patients with available data maintained a mean 2.88-point improvement in the MG-ADL score and an 8.25-point improvement in the QMG score from baseline. Corticosteroid use also declined, with three of six adolescents taking steroids at study entry reducing their dose and one discontinuing treatment after two years. No new safety signals were identified.

Johnson & Johnson also presented retrospective real-world data from healthcare professionals treating adults with anti-AChR or anti-MuSK antibody-positive gMG. Fluctuating symptom control was cited as the most common reason for stopping a previous advanced therapy.

Among 97 patients who switched to IMAAVY, 73.2% were reported as “much improved” or “very much improved.” Among patients receiving prednisone, 76.4% reduced their dose and 5.5% discontinued it.

IMAAVY is an FcRn blocker approved for adults and patients aged 12 and older with antibody-positive generalized myasthenia gravis. The new findings add longer-term evidence supporting sustained disease control and reduced corticosteroid dependence.
Post Image
Johnson & Johnson Highlights Two-Year IMAAVY Data Showing Sustained Disease Control in gMG

Johnson & Johnson reported new two-year data for IMAAVY in generalized myasthenia gravis, showing sustained improvements in daily function and muscle strength among adolescents treated in the Phase 2/3 Vibrance-MG long-term extension study.

At Week 108, patients with available data maintained a mean improvement of 2.88 points on the MG-ADL scale and 8.25 points on the QMG scale from baseline. Corticosteroid use also declined, with three of six adolescents on steroids at study entry reducing their dose and one discontinuing treatment after two years. No new safety signals were identified over the treatment period.

Johnson & Johnson also presented real-world survey data from healthcare professionals treating adults with anti-AChR or anti-MuSK antibody-positive gMG. Fluctuating symptom control was the most frequently cited reason for discontinuing a prior advanced therapy, while a consistent treatment schedule and expectations for improved efficacy were the main reasons for switching to IMAAVY.

Among 97 patients who transitioned to IMAAVY, healthcare professionals reported that 73.2% were “much improved” or “very much improved.” Among patients receiving prednisone, 76.4% reduced their dose and 5.5% discontinued it.

IMAAVY is an FcRn blocker approved for adults and patients aged 12 years and older with anti-AChR or anti-MuSK antibody-positive generalized myasthenia gravis. The latest data strengthen Johnson & Johnson’s clinical case for the treatment by showing durability of response and potential steroid-sparing benefits across longer-term use.
Post Image
Johnson & Johnson’s TREMFYA Meets Key Endpoints in Phase 4 Axial Psoriatic Arthritis Study

Johnson & Johnson (NYSE: JNJ) said TREMFYA (guselkumab) met the primary and major secondary endpoints in the Phase 4 STAR study evaluating biologic-naïve adults with active psoriatic arthritis and axial involvement. The company said the treatment improved spinal pain, stiffness and other axial symptoms while also reducing MRI-confirmed inflammation.

TREMFYA achieved a significant improvement in the BASDAI disease activity score at Week 24 versus placebo and also met secondary endpoints measuring axial symptoms through ASDAS-CRP and inflammation of the sacroiliac joints by MRI. Johnson & Johnson said the safety profile was consistent with TREMFYA’s established profile in psoriatic arthritis, with no new safety signals identified.

The STAR study enrolled 411 patients and is notable for using MRI-confirmed axial inflammation both for patient selection and for assessing treatment response. Johnson & Johnson said the results strengthen the evidence for TREMFYA in axial psoriatic arthritis, an area where dedicated prospective trials remain limited.

TREMFYA is already approved for active psoriatic arthritis and several other inflammatory diseases, and Johnson & Johnson recently received an FDA label expansion recognizing its ability to inhibit progression of structural joint damage in adults with active PsA. Detailed STAR efficacy and safety data are expected at an upcoming scientific congress.
Post Image
Johnson & Johnson Highlights Strong Long-Term Survival Potential for TECVAYLI-DARZALEX Combination

Johnson & Johnson reported new MajesTEC-3 analyses suggesting that TECVAYLI plus DARZALEX FASPRO could materially improve long-term outcomes for patients with relapsed or refractory multiple myeloma treated as early as second line.

A model-based analysis estimated that about 87% of patients receiving the combination could eventually have a mortality risk similar to an age-matched general population. Projected remaining life expectancy was 18.5 years with TECVAYLI-DARZALEX versus 4.9 years with the standard-of-care comparator, approaching 21.1 years for the matched general population.

A separate analysis showed that the combination reduced the risk of disease progression by 90% versus standard care. At 36 months, progression had occurred in 8.7% of patients receiving TECVAYLI-DARZALEX compared with 62.1% in the control group. Overall survival at three years was 83.3% versus 65.0%, while non-relapse mortality was not significantly different between the groups.

The findings build on the Phase 3 MajesTEC-3 trial, which evaluates the combination in patients who had received one to three prior therapies. Johnson & Johnson said continued follow-up will be needed to determine whether the model-based long-term survival projections are borne out over time.

The data strengthen the case for moving TECVAYLI earlier in the multiple myeloma treatment pathway and reinforce Johnson & Johnson’s broader strategy of combining bispecific antibodies with established myeloma therapies.
Post Image
Johnson & Johnson’s CAPLYTA Shows Rapid Improvement in Bipolar Mania in Phase 3 Study

Johnson & Johnson reported positive Phase 3 results for CAPLYTA in adults with manic episodes associated with bipolar I disorder, with the drug significantly reducing manic symptoms versus placebo and showing improvement as early as Day 3.

The pivotal Study 451 met its primary endpoint. CAPLYTA 42 mg produced a 4.8-point greater reduction in the Young Mania Rating Scale score versus placebo at Week 3, with an effect size of -0.69 and p<0.0001. Benefits were sustained through Week 3.

Clinical response was also stronger with CAPLYTA, with 45.8% of treated patients achieving at least a 50% reduction in mania symptoms versus 20.9% for placebo. Patients also showed significantly greater improvement in overall illness severity.

The safety profile was consistent with CAPLYTA’s established profile, with dry mouth and nausea the most common treatment-related adverse events reported at higher rates than placebo.

CAPLYTA is already approved for bipolar depression, schizophrenia and as adjunctive treatment for major depressive disorder, but it is not currently approved for manic episodes in bipolar I disorder. A second pivotal Phase 3 mania study has been completed and is under analysis.
Post Image
Johnson & Johnson’s RYBREVANT Combination Extends Median Survival in Advanced Lung Cancer Study

Johnson & Johnson reported final Phase 3 data showing that RYBREVANT combined with chemotherapy achieved a median overall survival of 34.3 months in patients with advanced non-small cell lung cancer carrying EGFR exon 20 insertion mutations, compared with 27.9 months for chemotherapy alone.

The PAPILLON study evaluated first-line RYBREVANT plus carboplatin-pemetrexed against chemotherapy alone. Johnson & Johnson said the combination extended median survival by more than six months despite 76% of eligible patients in the chemotherapy group later crossing over to RYBREVANT after their disease progressed.

In the protocol-specified final analysis, the overall-survival hazard ratio was 0.87 and the result was not statistically significant. However, a prespecified analysis adjusting for crossover showed a 43% reduction in the risk of death, with a hazard ratio of 0.57 and nominal P value of 0.003. The treatment also extended progression-free survival through second disease progression to 28.3 months from 17.5 months.

The results are significant for a difficult-to-treat form of lung cancer. EGFR exon 20 insertion mutations account for roughly 12% of EGFR mutations and historically have been associated with median overall survival of about 16–24 months and a five-year survival rate of just 8%.

RYBREVANT is a bispecific antibody designed to target both EGFR and MET, pathways involved in tumor growth and treatment resistance. The latest results strengthen Johnson & Johnson’s clinical evidence for the therapy in EGFR-mutated lung cancer.
Post Image
Johnson & Johnson Receives CE Mark for New ACUVUE OASYS MAX Reusable Contact Lenses

Johnson & Johnson has received CE Marking for ACUVUE OASYS MAX 2-Week, expanding its ACUVUE portfolio with a new reusable contact lens designed to provide comfort and visual clarity throughout a two-week wear cycle. The product is expected to launch in select European markets later this year, followed by a broader rollout in 2027 and 2028.

The new lens incorporates the company’s OptiBlue Light Filter, which filters at least 60% of blue-violet light, along with TearStable Technology designed to retain moisture and Class 1 UV blocking. Johnson & Johnson is positioning the product for consumers facing increased screen exposure and demanding visual environments.

The company said 99% of existing ACUVUE OASYS 2-Week users participating in clinical testing were successfully refitted into the new lens using the same power, base curve and diameter.

The CE Mark clears ACUVUE OASYS MAX 2-Week for European markets. The product has not been approved by the U.S. Food and Drug Administration and is currently unavailable for sale in the United States.
Post Image
Johnson & Johnson to Present Phase 3 CAPLYTA Data at 2026 Psych Congress

Johnson & Johnson (NYSE: JNJ) will present 24 abstracts spanning its neuropsychiatry portfolio at the 2026 Psych Congress Annual Meeting, scheduled for September 15-19 in New Orleans.

A key focus will be the first presentation of pivotal Phase 3 data evaluating CAPLYTA (lumateperone) for the acute treatment of manic episodes, including episodes with mixed features, associated with bipolar I disorder. Additional CAPLYTA research will cover bipolar depression and major depressive disorder, including depressive symptoms, remission, patient subgroups and metabolic outcomes.

The company will also present new analyses of SPRAVATO (esketamine) examining its impact on anhedonia, a core symptom of depression associated with poorer treatment outcomes.

Johnson & Johnson’s broader neuroscience pipeline will also be represented. Phase 3 clinical trial data for seltorexant in major depressive disorder with insomnia symptoms are scheduled for presentation, alongside real-world research examining the disease burden and management of these patients.

Additional studies will focus on long-acting injectable treatments for schizophrenia, including hospitalization, relapse risk and patient treatment satisfaction.

The upcoming presentations highlight Johnson & Johnson’s efforts to expand its presence across mood disorders and other high-burden neuropsychiatric conditions, with the pivotal CAPLYTA bipolar mania results representing one of the most closely watched updates.
Video Thumbnail
05-02-26WS News
Video Thumbnail
12-30-25European Investor
Video Thumbnail
10-14-25European Investor
Video Thumbnail
10-04-25European Investor
Video Thumbnail
04-15-25WS News