NYSE:JNJ

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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.
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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.
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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.
Johnson & Johnson Wins FDA Approval for IMAAVY in First-Ever wAIHA Treatment

Johnson & Johnson (NYSE: JNJ) received a major regulatory win after the U.S. Food and Drug Administration approved IMAAVY (nipocalimab-aahu) for warm autoimmune hemolytic anemia, or wAIHA, in adults and patients aged 12 and older who are currently or were previously treated with corticosteroids. It is the first FDA-approved therapy specifically for the rare and potentially life-threatening disease.

Why the FDA Approval Matters

Warm autoimmune hemolytic anemia occurs when pathogenic IgG autoantibodies attack and destroy red blood cells, potentially causing severe anemia and debilitating fatigue. Previous treatment options were largely corticosteroids and immunosuppressants, which broadly suppress the immune system rather than specifically targeting the disease-driving antibodies.

IMAAVY takes a more targeted approach. The drug blocks the neonatal Fc receptor, or FcRn, reducing circulating pathogenic IgG antibodies while preserving B-cell function.

The approval was supported by the Phase 2/3 ENERGY study. Approximately three times as many patients receiving the approved IMAAVY dose achieved a durable hemoglobin response compared with placebo at 24 weeks. Patients also showed a mean hemoglobin increase of 1 g/dL as early as Week 1, while fatigue scores improved versus placebo.

IMAAVY Franchise Expands

The approval also broadens the commercial potential of IMAAVY. The drug was previously approved in the U.S. for generalized myasthenia gravis, making wAIHA its second approved indication. Johnson & Johnson is studying nipocalimab across several additional autoantibody-driven diseases.

For Johnson & Johnson, the FDA decision strengthens its immunology portfolio while giving IMAAVY a first-mover position in a disease with significant unmet medical need.
Johnson & Johnson (NYSE: JNJ) gained 3.5% on Friday after receiving fresh analyst support, helping extend the stock's recent strength.

Johnson Rice initiated coverage with a $270 price target, while Guggenheim raised its price target to $270 from $266 and maintained its Buy rating. The updated analyst views reflect confidence in the company's diversified healthcare business, resilient pharmaceutical portfolio, and improving growth outlook.

Analysts continue to view Johnson & Johnson as well positioned to benefit from steady demand for its innovative medicines, expanding medtech business, and strong cash generation. The company is also expected to maintain its defensive appeal amid ongoing macroeconomic uncertainty.

The positive analyst actions reinforced investor sentiment, supporting gains in Johnson & Johnson shares as healthcare stocks attracted renewed interest.
Johnson & Johnson announced that the U.S. Food and Drug Administration has granted Priority Review to its drug IMAAVY (nipocalimab) for the treatment of warm autoimmune hemolytic anemia (wAIHA), a rare and life-threatening blood disorder.

Priority Review shortens the FDA evaluation timeline to around six months and is reserved for therapies that may offer significant improvements over existing options. Notably, IMAAVY is the first treatment to receive this designation for wAIHA, where no approved therapies currently exist.

Source: PRNewswire
Johnson & Johnson reported new long-term data showing that its investigational therapy IMAAVY (nipocalimab) delivered sustained disease control in patients with generalized myasthenia gravis (gMG) for over two years. Results from the Phase 3 Vivacity-MG3 study and its extension phase demonstrated continued improvements in symptoms, muscle strength, and quality of life, along with significant reductions in harmful IgG antibodies.

The data also indicated that patients achieving sustained minimal symptom expression experienced greater quality-of-life benefits, while many were able to reduce corticosteroid use. In parallel, Johnson & Johnson confirmed that its head-to-head EPIC study comparing IMAAVY with another FcRn blocker is now enrolling participants.

Source: PR Newswire
Johnson & Johnson unveiled new advancements in its electrophysiology portfolio at the Heart Rhythm Society (HRS) 2026 meeting, including the launch of the AI-powered CARTOSOUND SONATA module. The new technology enhances cardiac imaging and mapping by automatically converting intracardiac ultrasound data into detailed heart models, improving precision in treating arrhythmias.

The innovation integrates with existing CARTO systems and supports procedures for conditions such as atrial fibrillation and ventricular tachycardia. The company also presented new clinical data on its VARIPULSE platform, highlighting improved safety, efficiency, and real-world patient outcomes in pulsed field ablation therapies.

Marking 30 years of the CARTO system, Johnson & Johnson emphasized its continued focus on AI-driven innovation to advance cardiac care and improve treatment outcomes for heart rhythm disorders.
Business Wire
Johnson & Johnson (NYSE: JNJ) announced a 3.1% increase in the quarterly dividend, from $1.30 per share to $1.34 per share.

The next quarterly dividend is payable on June 9, 2026 to shareholders of record at the close of business on May 26, 2026. The ex-dividend date is May 26, 2026.
Johnson & Johnson presented new clinical data for its TECNIS PureSee intraocular lens (IOL) at the 2026 ASCRS Annual Meeting, highlighting strong visual performance and patient outcomes.

Results from multiple studies across the U.S., Europe, and Asia-Pacific showed the lens delivers excellent distance and intermediate vision, high contrast sensitivity, and low levels of visual disturbances, alongside high patient satisfaction and reduced dependence on glasses.

The findings reinforce the product’s positioning as a next-generation extended depth-of-focus lens, supporting Johnson & Johnson’s strategy to advance innovation in vision care and improve surgical outcomes for cataract patients.
Business Wire
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