Johnson and Johnson (JNJ)

New TALVEY® (talquetamab-tgvs) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) data demonstrate the strength of a bispecific combination in earlier-line relapsed or refractory multiple myelomaJune 13, 2026 6:33 AM
PR Newswire (US) TALVEY® plus DARZALEX FASPRO® with or without pomalidomide showed progression-free survival of up to 81% and overall survival of up to 89% at 24 monthsMonumenTAL-3 is the third positive study in recent months from Johnson & Johnson's bispecific portfolio and is the first Phase 3 study of a GPRC5D bispecific investigational combinationResults reinforce Johnson & Johnson's leadership in multiple myeloma, advancing bispecific combinations earlier in the treatment journey, and expanding options to match the right treatment to the right patient and stage of diseaseSTOCKHOLM, June 13, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced results from the investigational Phase 3 MonumenTAL-3 study showing that TALVEY® (talquetamab-tgvs), a GPRC5D bispecific antibody, in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) with or without pomalidomide demonstrated significant reduction in the risk of disease progression or death of up to 72% and clinically meaningful reduction of up to 53% in the risk of death compared to the standard regimen of DARZALEX FASPRO®, pomalidomide, and dexamethasone (DPd) in patients with relapsed/refractory multiple myeloma (RRMM).1 Results showed a progression-free survival (PFS) rate of up to 81.3% versus standard of care (51.2%) and an overall survival (OS) rate of up to 89.2% versus standard of care (79.1%) at 24 months.1   This is the first Phase 3 study to demonstrate superior PFS with a GPRC5D bispecific antibody combination in earlier-line multiple myeloma, underscoring the potential of this regimen to advance bispecific combinations earlier in the treatment paradigm.1 Results were presented at the 2026 European Hematology Association (EHA) Annual Meeting (Abstract #S100), with simultaneous publication in The New England Journal of Medicine.Expert and company perspectives support bispecific combinations in earlier lines
"The impressive results from this study point to the promise of TALVEY plus DARZALEX FASPRO as a potential new bispecific combination for patients with relapsed or refractory multiple myeloma," said Peter Voorhees, M.D., Professor of Hematology and Oncology at Atrium Health, Levine Cancer Institute at Wake Forest University School of Medicine.* "TALVEY works with DARZALEX FASPRO in earlier lines—a critical time for treating patients with the most effective regimens.""The MonumenTAL-3 findings underscore our commitment to bringing bispecific combinations into earlier lines of therapy, building on the strength and breadth of Johnson & Johnson's multiple myeloma portfolio," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson. "These results add to our growing body of evidence across bispecific antibodies and reinforce our strategy of advancing differentiated immunotherapies to better match the right therapy to the right patient at each stage of disease."Novel mechanism spares healthy immune cells
TALVEY ® targets a protein called GPRC5D, which is found on multiple myeloma cells (as well as some healthy cells in the body).2 GPRC5D expression is independent of other targets, including BCMA, and is absent or expressed at low levels on normal B-Cells.2 TALVEY® works by targeting myeloma cells while largely sparing healthy B-cells.2Phase 3 MonumenTAL-3 study results
The MonumenTAL-3 study evaluated TALVEY® with DARZALEX FASPRO® (Tal-D) or TALVEY® with DARZALEX FASPRO® and pomalidomide (Tal-DP) compared to DPd in patients with RRMM who have received at least one prior line of therapy.1 At a median follow-up of two years (24.6 months), results showed significant improvement in PFS for Tal-DP (hazard ratio [HR], 0.28; 95 percent confidence interval [CI], 0.20-0.40; p

Johnson & Johnson Reports Strong Late-Stage Results for Rare Blood Disorder Therapy (JNJ)June 11, 2026 8:40 AM
IH Market News Johnson & Johnson (NYSE:JNJ) has announced positive findings from its Phase 2/3 ENERGY clinical trial, with IMAAVY (nipocalimab-aahu) demonstrating statistically significant improvements in hemoglobin levels among patients with warm autoimmune hemolytic anemia compared with placebo. The results provide further support for the therapy as the company seeks regulatory approval for a condition that currently has no FDA-approved treatment options. Trial Meets Primary Endpoint The randomized, placebo-controlled study showed that patients receiving the 30 mg/kg dose of IMAAVY achieved sustained hemoglobin improvements at roughly three times the rate observed in the placebo group after 24 weeks of treatment. Patients treated with the therapy also experienced an average hemoglobin increase of at least 1 g/dL as early as the first week of treatment. The trial’s primary endpoint focused on durable hemoglobin improvement, defined as an increase of at least 2 g/dL from baseline and a hemoglobin concentration of at least 10 g/dL across three visits over a 28-day period beginning by Week 16, without the need for rescue therapy or adjustments to background medications. Significant Improvement in Patient Outcomes According to the study results, nearly two-thirds of patients receiving the 30 mg/kg dose achieved both a hemoglobin level of at least 10 g/dL and an increase of at least 2 g/dL from baseline by Week 24. Beyond improvements in hemoglobin levels, the treatment was also associated with reduced fatigue and lower reliance on steroid therapy, both important measures for patients living with the disease. The findings suggest that IMAAVY could provide meaningful clinical benefits for individuals affected by the rare autoimmune condition. Safety Profile Remains Consistent Johnson & Johnson reported that IMAAVY’s safety profile in the study was consistent with its approved use in patients with generalized myasthenia gravis. Among patients with warm autoimmune hemolytic anemia, the most frequently reported adverse events were peripheral edema, diarrhea and fever, each occurring in at least 10% of treated participants. The company indicated that no new safety concerns were identified during the trial. Regulatory Review Underway Warm autoimmune hemolytic anemia is a rare and potentially life-threatening disease in which the immune system destroys red blood cells, leading to anemia and other serious complications. Currently, there are no FDA-approved therapies specifically indicated for the condition. Johnson & Johnson has already submitted a supplemental Biologics License Application for IMAAVY, and the treatment has been granted Priority Review status by the U.S. Food and Drug Administration. Data Presented at Major Hematology Conference The results from the ENERGY study were presented at the European Hematology Association 2026 Congress, according to the company. The positive data strengthen Johnson & Johnson’s position in rare disease treatment and could support the expansion of IMAAVY into an additional therapeutic indication if regulatory approval is secured. Johnson & Johnson stock price Original: Johnson & Johnson Reports Strong Late-Stage Results for Rare Blood Disorder Therapy (JNJ)

Johnson & Johnson Expands U.S. Availability of TECNIS PureSee IOL, an Advanced Lens Option for Cataract Surgeons and PatientsJune 11, 2026 7:45 AM
Business Wire Expanded U.S. availability paired with new patient lifestyle quiz encourages informed decision-making ahead of cataract surgery. Cataracts are one of the leading causes of vision impairment.1 Nearly 20% of Americans aged 40+ live with cataracts that make everyday tasks more challenging, yet only 5% have had cataract surgery.2 Over half a million eyes worldwide have already experienced clearer, extended range of vision with TECNIS PureSee IOL after cataract surgery.3,4 97% of patients would recommend TECNIS PureSee IOL to friends or family.5 Johnson & Johnson (NYSE: JNJ) is expanding the U.S. roll-out of its latest advancement in presbyopia-correcting intraocular lenses (PC-IOLs). TECNIS PureSee IOL is an extended depth of focus (EDOF) lens designed to support visual clarity and quality for patients undergoing cataract surgery.3 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611210092/en/ Benefits of TECNIS PureSee IOL: Range of vision: Excellent distance and intermediate vision with some near vision3* Low level of bothersome visual symptoms: 97% of patients reported no very bothersome visual disturbances3 Vibrant vision: Excellent vision, day and night3 “With the full U.S. availability of TECNIS PureSee IOL, we are expanding access to an important extended depth of focus option that reflects our commitment to innovation, visual quality, and patient satisfaction,”3 said Erin Powers, President, Surgical Vision, North America, Johnson & Johnson. “Patients today want vision solutions that support how they live their lives every day. TECNIS PureSee IOL builds on the trusted TECNIS platform to help meet those expectations while giving surgeons greater flexibility to personalize care.” The expanded U.S. availability of TECNIS PureSee IOL comes during Cataract Awareness Month, a time dedicated to raising awareness about this common and preventable cause of vision loss. Cataract surgery is one of the most common and safe procedures in the U.S., with a success rate of nearly 98%.6 In a single procedure, TECNIS PureSee IOL addresses both cataract-related vision loss and the effects of presbyopia,3 which occurs when your eyes gradually lose the ability to see objects clearly up close.7 Nearly everyone will get presbyopia by the age of 50.8 TECNIS PureSee IOL is the first and only U.S. FDA-approved extended depth of focus (EDOF) IOL with no warning on loss of contrast sensitivity.3** Contrast sensitivity refers to a patient’s ability to distinguish an object from its background, an important part of visual quality, especially in low-light or foggy conditions. Aspheric monofocal IOLs are widely considered the benchmark for preserving contrast sensitivity. By maintaining contrast sensitivity comparable to an aspheric monofocal IOL, TECNIS PureSee IOL helps patients experience the visual clarity and confidence they expect, while also benefiting from an extended range of vision.3 “I was an investigator with the TECNIS PureSee IOL, so I have firsthand experience with this lens, and I’m excited to have this option in my practice for patients,” said Daniel Chang, MD, Cataract and Refractive Surgeon, Empire Eye & Laser Center.^ “This is the first presbyopia-correcting lens I’ve seen that has similar, if not in some cases even fewer, night vision symptoms than a monofocal lens.3 This is a very exciting time for the TECNIS platform. I think TECNIS PureSee IOL is going to be a landmark advancement.” New patient lifestyle quiz To further support patient education during Cataract Awareness Month, Johnson & Johnson is encouraging individuals to take a new patient lifestyle quiz designed to help them reflect on their daily activities, vision needs, and goals ahead of cataract surgery. Patients can use the quiz as a starting point for informed conversations with their eye care professional about which TECNIS IOL, including the TECNIS PureSee IOL, may be right for them. For more patient information and tools please visit www.clearvisionforyou.com. Visit us at jnjvisionpro.com/en-us/ and follow Johnson & Johnson | Vision on LinkedIn. INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS PureSee™ IOL and TECNIS PureSee™ Toric II IOLs with TECNIS SIMPLICITY™ Delivery System Rx Only INDICATIONS FOR USE The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS PureSee™ IOL, which is indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee™ IOL provides improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only. The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS PureSee™ Toric II IOLs, which are indicated for primary implantation for the visual correction of aphakia and for reduction of refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee™ Toric II IOLs provide improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lenses are intended for capsular bag placement only. WARNINGS Physicians should weigh the potential benefit/risk ratio of IOL implantation in patients with any of the conditions listed below, as intraocular lenses may exacerbate an existing condition or may pose an unreasonable risk to the eyesight of patients. The following conditions are not specific to the design of the IOL and are attributed to cataract surgery and/or IOL implantation in general: Recurrent severe anterior or posterior segment inflammation of unknown etiology Posterior segment diseases of which monitoring or treatment ability may be limited by an intraocular lens Surgical difficulties at the time of cataract extraction and/or intraocular lens implantation that might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss) Compromised posterior capsule or zonules due to previous trauma or developmental defect in which appropriate support of the IOL is not possible Risk of damage to the endothelium during implantation Suspected microbial infection Congenital bilateral cataracts Previous history of, or a predisposition to, retinal detachment Potentially good vision in only one eye Medically uncontrollable glaucoma Corneal endothelial dystrophy Proliferative diabetic retinopathy Rotation of the toric lens away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation. Do not attempt to disassemble, modify or alter the delivery system or any of its components, as this can significantly affect the function and/or structural integrity of the design. Do not use if the cartridge of the delivery system is cracked or split prior to implantation. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the delivery system. Do not stop, reverse or advance the plunger too slowly (for example more than 1 second) during initial lens advancement. Doing so may result in improper folding of the lens. Do not advance the lens from the Holding Position prior to fully hydrating the system. A minimum of 1 minute at the Holding Position is required to fully hydrate the system to prevent sticking and a potential scratch or crack to the lens. Do not advance the lens from the Holding Position until ready for implantation. Interruptions during delivery may result in the lens being scratched or cracked or stuck in the cartridge. Discard the device if the lens has been advanced past the Holding Position but not delivered within 60 seconds. The lens and delivery system should be discarded if the lens has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge. Johnson & Johnson Surgical Vision, Inc., single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. When used according to the directions for use, the delivery system minimizes the risk of infection and/or inflammation associated with contamination. The reuse/resterilization/reprocessing of Johnson & Johnson Surgical Vision, Inc. single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient contamination, transmission of infection, and lack of product sterility. PRECAUTIONS Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient. Autorefractors may not provide optimal postoperative refraction of patients with the IOL. Manual refraction with maximum plus technique is strongly recommended. This is a single-use device. Do not resterilize the lens or the delivery system. Most sterilizers are not equipped to sterilize the soft acrylic material of the IOL and the preloaded inserter material without producing undesirable side effects. Do not store the device in direct sunlight or at a temperature under 41°F (5°C) or over 95°F (35°C). Do not autoclave the delivery system. The contents are sterile unless the package is opened or damaged. Do not use if the delivery system has been dropped or if any part was inadvertently struck while outside the shipping box. The sterility of the delivery system and/or the lens may have been compromised. The recommended temperature for implanting the lens is at least 63°F (17°C). Do not advance the lens unless ready for lens implantation. Do not leave the lens in a folded position more than 10 minutes. When the delivery system is used improperly, the lens may not be delivered properly (i.e., haptics may be broken). Please refer to the specific Directions For Use section provided. The use of balanced salt solution or ophthalmic viscosurgical devices (OVDs) is required when using the delivery system. For optimal performance when using OVD, use the HEALON™ family of OVDs. The use of balanced salt solution with additives has not been studied for this product. The lens should be placed entirely in the capsular bag. The lens should not be placed in the ciliary sulcus. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or over-inflation of the capsular bag may allow the lens to rotate, causing misalignment of the toric lens with the intended axis of placement. Do not reuse. Recent contact lens usage may affect the patient’s refraction; therefore, in contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. The IOL is designed for optimum visual performance when emmetropia is targeted. The TECNIS™ Toric IOL Calculator includes a feature that accounts for posterior corneal astigmatism (PCA). The PCA is based on an algorithm that combines published literature (Koch, et al., 2012) and a retrospective analysis of data from a TECNIS™ Toric multi-center clinical study. The PCA algorithm for the selection of appropriate cylinder power and axis of implantation was not assessed in the prospective TECNIS™ Toric IOL U.S. IDE study and may yield results different from those in the TECNIS PureSee™ Toric II IOL labeling. Please refer to the TECNIS™ Toric IOL Calculator user manual for more information. The use of methods other than the TECNIS™ Toric IOL Calculator to select cylinder power and appropriate axis of implantation were not assessed in the TECNIS™ Toric IOL U.S. IDE study and may not yield similar results. Accurate keratometry and biometry, in addition to the use of the TECNIS™ Toric IOL Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes for the TECNIS PureSee™ Toric II IOLs. All preoperative surgical parameters are important when choosing a toric lens for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, the surgeon’s estimated surgically induced astigmatism (SIA) and biometry. Variability in any of the preoperative measurements can influence patient outcomes and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. The effectiveness of the toric lens in reducing postoperative residual astigmatism in patients with preoperative corneal astigmatism less than 1.0 diopter has not been demonstrated. All corneal incisions were placed temporally in the TECNIS™ Toric IOL U.S. IDE study. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained for the TECNIS™ Toric IOL. Note that the TECNIS™ Toric IOL Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options. Children under the age of 2 years are not suitable candidates for intraocular lenses. The safety and effectiveness of the TECNIS PureSee™ IOLs have not been substantiated in pregnant women, patients under the age of 22 or those with preexisting ocular conditions and intraoperative complications, including those specified in the Warnings and Precautions. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more of these conditions. Before Surgery Pupil abnormalities Prior corneal refractive or intraocular surgery Choroidal hemorrhage Chronic severe uveitis Concomitant severe eye disease Extremely shallow anterior chamber Medically uncontrolled glaucoma Microphthalmos Non-age-related cataract Proliferative diabetic retinopathy (severe) Severe corneal dystrophy Severe optic nerve atrophy Irregular corneal astigmatism Amblyopia Macular disease During Surgery Excessive vitreous loss Non-circular capsulotomy/capsulorhexis The presence of radial tears known or suspected at the time of surgery Situations in which the integrity of the circular capsulotomy/ capsulorhexis cannot be confirmed by direct visualization Cataract extraction by techniques other than phacoemulsification or liquefaction Capsular rupture Significant anterior chamber hyphema Uncontrollable positive intraocular pressure Zonular damage 24. Potential complications generally associated with cataract surgery include, but are not limited to: endophthalmitis/intraocular infection, hypopyon, hyphema, IOL dislocation, persistent cystoid macular edema, pupillary block, retinal detachment/tear, persistent corneal stromal edema, persistent uveitis, persistent raised intraocular pressure (IOP) requiring treatment (e.g., AC tap), retained lens material, or toxic anterior segment syndrome, or any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment. ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information About Vision at Johnson & Johnson Johnson & Johnson has a deep legacy in developing transformational new products that improve the health of patients’ eyes. We have a bold ambition: Vision Made Possible – improving sight for more than 40 million people each year. Through cutting-edge innovation, expertise in material and optical science, and advanced technologies, we are revolutionizing the way people see and experience the world. Visit us at clearvisionforyou.com, follow @JNJVision on X, Johnson & Johnson | Vision on LinkedIn, and @JNJVision on Facebook. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://www.jnjmedtech.com/en-US/. Follow us at @JNJMedTech on LinkedIn. Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to TECNIS PureSee IOL. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. ©Johnson & Johnson and its affiliates 2026. All rights reserved. Footnotes: *TECNIS PureSee IOL achieved a 1.5-line difference in mean monocular distance-corrected near VA at 6 months compared to TECNIS 1-Piece. **In clinical evaluation, TECNIS PureSee IOL demonstrated contrast sensitivity comparable to an aspheric monofocal intraocular lens, with no clinically meaningful differences (≤0.3 log units) versus aspheric monofocal controls across pupil sizes, while maintaining distance visual acuity and low levels of visual symptoms. ^Daniel Chang, MD, is a paid consultant of Johnson & Johnson World Health Organization (WHO), 2022. Blindness and vision impairment. Available at: https://www.who.int/news-room/fact-sheets/detail/blindness-and-visual-impairment. Centers for Disease Control and Prevention (2024) Cataract Data. Available from: https://www.cdc.gov/vision-health/about-eye-disorders. TECNIS PureSee™ IOL, Model DEN00V, DFU US, Z312075E rev B. Launch to Date Implants. Data on File. DOF2023CT4043 Clinical Investigation. Patient Satisfaction Outcomes. July 18, 2023. Harvard Medical School (2020) Considering Cataract Surgery? What You Should Know. Harvard Health Publishing REF2022OTH4464. American Academy of Ophthalmology. What Is Presbyopia? https://www.aao.org/eye-health/diseases/what-is-presbyopia Vision Loss Expert Group of the Global Burden of Disease Study and GBD 2019 Blindness and Vision Impairment Collaborators, 2024. Global estimates on the number of people blind or visually impaired by uncorrected refractive error: a meta-analysis from 2000 to 2020. Eye, 38, pp.2083–2101. https://doi.org/10.1038/s41433-024-03106-0 2026PP10682 View source version on businesswire.com: https://www.businesswire.com/news/home/20260611210092/en/ Media contact:
Maggie Lorenz
J&J | Communications

IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven disease with no FDA-approved therapiesJune 11, 2026 2:03 AM
PR Newswire (US) Patients in the IMAAVY 30 mg/kg treatment groupa achieved statistically significant durable hemoglobin responseb, with mean hemoglobin improvement of at least 1 g/dL as early as Week 1c More patients treated with IMAAVY experienced improvement in fatigued and corticosteroid dose reductionse IMAAVY is designed to target pathogenic immunoglobulin G (IgG) autoantibodies in warm autoimmune hemolytic anemia while preserving immune function Pivotal results will be presented at EHA 2026 STOCKHOLM, June 11, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today is presenting the first comprehensive results from the Phase 2/3 ENERGY study showing that IMAAVY® (nipocalimab-aahu) produced a statistically significant durable hemoglobin (Hgb) responseb with rapid onset of effect in patients with warm autoimmune hemolytic anemia (wAIHA)e in the 30 mg/kg treatment group,a compared with those who received placebo. The randomized, placebo-controlled trial demonstrated approximately three times as many patients achieved durable Hgb levels versus placebo by 24 weeks. Overall, patients treated with this dose of IMAAVY showed a mean Hgb improvement of at least 1g/dL as early as Week 1.1,c  To be presented at the European Hematology Association (EHA) 2026 Congress, these results mark an important step forward for people living with wAIHA, a rare, life-threatening condition for which patients currently have no U.S. Food and Drug Administration (FDA)-approved treatment options."These data from the Phase 2/3 ENERGY study showed the rapid onset of effect and durable improvement in anemia which occurs by targeting the autoantibody-mediated destruction of red blood cells in people living with warm autoimmune hemolytic anemia," said Bruno Fattizzo, M.D., Assistant Professor at the Department of Oncology and Hematology-Oncology, University of Milan, Italy.g "Achieving hemoglobin improvements this quickly and at this scale is important in clinical practice, as it could help improve the debilitating fatigue that people living with warm autoimmune hemolytic anemia experience."Key findings from the Phase 2/3 ENERGY study
The ENERGY study compared IMAAVY to placebo in achieving the primary endpoint of durable Hgb improvement, which was defined as achieving the following stringent criteria1: An increase from baseline in Hgb ≥2 g/dL Hgb concentration ≥10 g/dL For at least three visits (≥28 days, where criteria was met, starting by Week 16)Without the need for rescue therapy or changes to background medications for wAIHAIn the 30 mg/kg treatment group, a mean increase of 1 g/dL in Hgb was observed at Week 1, compared to no change in the placebo group.c In wAIHA, treatment also aims to maintain Hgb ≥10 g/dL and achieve a ≥2 g/dL increase from baseline and nearly two-thirds of patients achieved both of these targets by Week 24.IMAAVY was also associated with improvements in fatigued and reduction in steroid usef, two key secondary endpoints. Changes in patient-reported fatigue were observed as early as Week 2 and sustained throughout the 24-week treatment period.dIn the study, IMAAVY demonstrated a safety profile consistent with the established safety profile of IMAAVY in the approved indication of generalized myasthenia gravis. The most common adverse reactions (≥10%) in patients with wAIHA treated with IMAAVY were peripheral edema, diarrhea and fever.By targeting the pathogenic IgG autoantibodies that lead to red blood cell destruction in wAIHA, IMAAVY is designed to utilize a differentiated, immunoselective approach, preserving underlying key humoral immune functions in a condition where many patients currently can only rely on unapproved therapies, including corticosteroids and broad immunosuppressants.2"In the first large, placebo-controlled trial of its kind, IMAAVY delivered durable improvements in hemoglobin levels and showed no new safety signals, in a disease with no FDA-approved therapies," said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson. "This immunoselective approach targets the underlying autoantibodies driving disease while preserving key immune functions, which is important for people living with this disease who frequently suffer with comorbid conditions."These data support the supplemental Biologics License Application (sBLA) for IMAAVY which has since been granted U.S. FDA Priority Review. Editor's Notes:a.  The dose submitted to the FDA for approval (30 mg/kg IV every four weeks). 
b.   Durable hemoglobin response, the primary endpoint of the Phase 2/3 ENERGY trial, is defined as hemoglobin concentration ≥10 g/dL and an increase from baseline in hemoglobin ≥2 g/dL for at least 28 days (where criteria was met starting by Week 16 of the double-blind period), without the need of rescue therapy. This endpoint was prespecified within the equal-weight hierarchical testing procedure; the resulting one-sided p-value was considered statistically significant in accordance with the predefined multiplicity control strategy.
c.   These data were not a part of the hierarchical testing procedure.
d.   Based on mean change from baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score at Week 24, a key secondary endpoint, with mean change of 3.51 points over placebo for 30 mg/kg IV treatment group (dose filed with the FDA). This endpoint was prespecified within the hierarchical testing procedure; the resulting one-sided p-value was considered nominal in accordance with the predefined multiplicity control strategy.
e.   IMAAVY is not approved for the treatment of warm autoimmune hemolytic anemia.
f.   Participants who achieved durable Hgb response were required to initiate corticosteroid (CS) dose tapering. Doses were reduced by 10% of the baseline CS dose every two weeks, provided Hgb levels did not decline by ≥1 g/dL. At Week 24, the mean percent reduction in CS dose was numerically higher in the nipocalimab 30 mg/kg treatment group (15% reduction from baseline dose) compared with placebo (4% reduction from baseline dose). This endpoint was prespecified within the hierarchical testing procedure.
g.   Dr. Bruno Fattizzo is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.ABOUT THE ENERGY TRIAL
ENERGY (NCT04119050) is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study evaluating the efficacy and safety of nipocalimab compared with placebo followed by an open-label extension period, in adults living with warm autoimmune hemolytic anemia (wAIHA). 115 adults were randomized approximately 1:1:1 to receive nipocalimab at two different dose schedules or placebo. Following completion of 24 weeks of double-blind treatment, patients could enter an open-label extension period to receive nipocalimab for 144 weeks with a follow-up period of 6 weeks after last assessment.3ABOUT WARM AUTOIMMUNE HEMOLYTIC ANEMIA (wAIHA)
Warm autoimmune hemolytic anemia (wAIHA) is a rare, life-threatening condition where autoantibodies attach to and destroy red blood cells (RBCs), resulting in anemia.4 Approximately 1-3 new people per 100,000 are affected by wAIHA per year, and about 1 in 8,000 individuals are living with the condition.4,5 This condition affects both women and men, and can affect people at any age with incidence increasing over the age of 50.5,6 Additionally, people with wAIHA are at increased risk of other serious complications such as venous thrombotic events, acute renal failure, and infection.7There are no Food and Drug Administration (FDA)-approved drugs indicated for wAIHA, and treatment typically consists of unapproved corticosteroids, broad immunosuppressants, and B-cell directed therapies.4 With an unmet need for treatment in wAIHA, novel therapies like nipocalimab are being developed to potentially address this need.7ABOUT IMAAVY (nipocalimab-aahu)
IMAAVY® is an immunoselective treatment designed to target, bind with high affinity, and block the neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving key immune functions. IMAAVY is currently approved for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.8Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases and Maternal Fetal diseases mediated by maternal alloantibodies, in which blockade of IgG binding to FcRn in the placenta is believed to limit transplacental transfer of maternal alloantibodies to the fetus. 3,9,10,11,12,13,14,15,16,17The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including: EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025U.S. FDA Fast Track designation in HDFN and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, FNAIT in March 2024, Sjögren's disease (SjD) in March 2025, and systemic lupus erythematosus (SLE) in January 2026U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, generalized myasthenia gravis (gMG) in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024 U.S. FDA granted Priority Review in gMG in Q4 2024 and wAIHA in Q2 2026The legal manufacturer for IMAAVY is Janssen Biotech, Inc.WHAT IS IMAAVY (nipocalimab-aahu)?
IMAAVY is a prescription medicine used to treat adults and children 12 years of age and older with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.It is not known if IMAAVY is safe and effective in children under 12 years of age.IMPORTANT SAFETY INFORMATION What is the most important information I should know about IMAAVY?IMAAVY is a prescription medicine that may cause serious side effects, including:Infections are a common side effect of IMAAVY that can be serious. Receiving IMAAVY may increase your risk of infection. Tell your healthcare provider right away if you have any of the following infection symptoms: feverchillsshiveringcough sore throatfever blistersburning when you urinate Allergic (hypersensitivity) reactions may happen during or up to a few weeks after your IMAAVY infusion. Get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion: a swollen face, lips, mouth, tongue, or throatdifficulty swallowing or breathing itchy rash (hives)chest pain or tightnessInfusion-related reactions are possible. Tell your healthcare provider right away if you get any of these symptoms during or a few days after your IMAAVY infusion: headacherashnauseafatigue dizzinesschillsflu-like symptomsredness of skinDo not receive IMAAVY if you have a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY. Reactions have included angioedema and anaphylaxis.Before using IMAAVY, tell your healthcare provider about all of your medical conditions, including if you:ever had an allergic reaction to IMAAVY.have or had any recent infections or symptoms of infection.have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY should not receive live vaccines.are pregnant, plan to become pregnant, or are breastfeeding. It is not known whether IMAAVY will harm your baby.Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY if IMAAVY is given during pregnancy or you become pregnant while receiving IMAAVY. Your healthcare provider should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.What are the possible side effects of IMAAVY?
IMAAVY may cause serious side effects. See "What is the most important information I should know about IMAAVY?"The most common side effects of IMAAVY include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.These are not all the possible side effects of IMAAVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.Please see the full Prescribing Information and Medication Guide for IMAAVY and discuss any questions you have with your doctor.Dosage Form and Strengths: IMAAVY is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com.Follow us at @JNJInnovMed. Janssen Biotech, Inc. is a Johnson & Johnson company. Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMAAVY. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.REFERENCES1 Fattizzo B, Murakhovskaya I, Ueda.Y, Schlichting D, Sweet K, Zelasky M, Craig J, Liva S, Leu J, Ling L, Pease S, Anakor A, Shu C, Nipocalimab for warm autoimmune hemolytic anemia: results from the Phase 2/3 randomized, double-blind ENERGY study, Presented at EHA 2026 Congress, Available at https://library.ehaweb.org/eha/2026/eha-2026/4206854/bruno.fattizzo.nipocalimab.for.warm.autoimmune.hemolytic.anemia.results.from.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Asearch%3DS300
2 Seth N, et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. mAbs. 2025 Feb; 17(1).?https://doi.org/10.1080/19420862.2025.2461191
3 ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050. Last accessed: June 2026.
4 National Organization for Rare Disorders, Warm autoimmune Hemolytic Anemia. Available at: https://rarediseases.org/rare-diseases/warm-autoimmune-hemolytic-anemia/. Last accessed: June 2026.
5 Tranekær S, Hansen DL, Frederiksen H. Epidemiology of Secondary Warm Autoimmune Haemolytic Anaemia-A Systematic Review and Meta-Analysis. J Clin Med. 2021 Mar 17;10(6):1244. doi: 10.3390/jcm10061244. PMID: 33802848; PMCID: PMC8002719.
6 Cherif, H, Cai, Q, Crivera, C, Leon, A, Rahman, I, Leval, A, Noel, W and Kjellander, C. (2024), Overall Survival and Treatment Patterns Among Patients With Warm Autoimmune Hemolytic Anemia in Sweden: A Nationwide Population-based Study. Eur J Haematol.?https://doi.org/10.1111/ejh.14311.
7 Fattizzo B, Barcellini W. New Therapies for the Treatment of Warm Autoimmune Hemolytic Anemia. Transfusion Medical Reviews, Vol. 36, Issue 4. October 2022 https://doi.org/10.1016/j.tmrv.2022.08.001.
8 IMAAVY® U.S. Prescribing Information.
9 ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622. Last accessed: June 2026.
10 ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: June 2026.
11 ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: June 2026.
12 ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: June 2026.
13 ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: June 2026.
14 ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: June 2026.
15 ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: June 2026.
16 ClinicalTrials.gov Identifier: NCT06449651. Available at: https://clinicaltrials.gov/study/NCT06449651. Last accessed: June 2026.
17 ClinicalTrials.gov Identifier: NCT06533098 Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: June 2026.Media contact:    Investor contact:Bridget Kimmel      Jess MargevichBKimmel@ITS.JNJ.com              Investor-relations@its.jnj.com  View original content to download multimedia:https://www.prnewswire.com/news-releases/imaavy-nipocalimab-aahu-demonstrates-durable-hemoglobin-response-and-rapid-onset-of-effect-in-pivotal-phase-23-study-in-warm-autoimmune-hemolytic-anemia-waiha-an-autoantibody-driven-disease-with-no-fda-approved-therapies-302797243.htmlSOURCE Johnson & Johnson Original: IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven disease with no FDA-approved therapies

Anyone seeing JNJ possibly buy any of the three major psychedelic companies? CMPS, DFTX or ATAI?

Johnson & Johnson presents new data further reinforcing the role of nipocalimab in lowering the autoantibodies driving Sjögren's diseaseJune 3, 2026 12:03 AM
PR Newswire (US) Nipocalimab, an immunoselective neonatal Fc receptor (FcRn) blocker, is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with Sjögren's disease while preserving immune function New exploratory analysis of Phase 2 study data shows a strong correlation between autoantibody levels and even greater clinical response rates of participants in the nipocalimab treatment group Previously reported data from the Phase 2 study showed nipocalimab reduced Sjögren's disease activity and severity, with potential to address systemic manifestations and the most burdensome patient-reported symptoms including dryness, fatigue and painNipocalimab is the only FcRn blocker granted both Breakthrough Therapy Designation and Fast Track Designation by the U.S. FDA for the treatment of adults with moderate-to-severe Sjögren's disease. LONDON, June 3, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new biomarker exploratory analyses from the Phase 2 DAHLIAS study evaluating nipocalimab in adults with moderate-to-severe Sjögren's disease (SjD)a showing that participants with elevated autoantibody and immunoglobulin G (IgG) levelsb, who are often those who experience more substantial disease burden, showed greater clinical response rates.1 These data will be presented in an oral session at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress. A healthcare professional's perspective
"Sjögren's disease is a highly heterogeneous condition that has historically posed significant challenges for therapeutic development, leaving gaps in patient care," said R. Hal Scofield, M.D., the University of Oklahoma and Oklahoma Medical Research Foundation.c "These analyses provide important insight into the potential role of pathogenic immunoglobulin G autoantibodies in disease activity and help expand our understanding of the biological drivers of Sjögren's disease for certain patients. This research is critical for helping clinicians evaluate emerging evidence and the evolving treatment landscape in this chronic, underserved disease."New DAHLIAS Phase 2 clinical and biomarker findings 
Clinical improvements were observed across all patients, with the greatest responses observed in participants with elevated known disease-driving autoantibodies and IgG levels – factors associated with more severe SjD activity and outcomes.1 Previously reported positive Phase 2 study results demonstrated statistically significant improvement in ClinESSDAId scores with nipocalimab versus placebo.2 In the current analysis, patients in the autoantibody-high subgroupb treated with nipocalimab achieved higher response rates than observed in the overall participant population (62.5% versus 51.9%).1 These data support the continued investigation of nipocalimab as a potential immunoselective approach for systemic SjD management in the ongoing Phase 3 DAFFODIL study.Biomarker analyses reveal autoantibody and immune function insights
These findings further support the underlying mechanism of action of nipocalimab as a targeted, immunoselective approach designed to reduce pathogenic IgG autoantibodies associated with SjD disease activity while preserving broader immune function.3"The biomarker analyses are consistent with the hypothesized mechanism of nipocalimab in Sjögren's disease. These findings suggest greater response in the broad study population of adults with moderate-to-severe Sjögren's disease, plus a greater response observed among patients with elevated disease-driving autoantibodies and immunoglobulin G levels," said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson. "The data also furthers our understanding of the role pathogenic IgG autoantibodies may play in this heterogenous disease as we continue to investigate nipocalimab in Sjögren's."Editor's Notes: a.Nipocalimab is not FDA approved for the treatment of SjD. b.Subgroup included patients with moderate-to-severe SjD who had the highest baseline levels of three disease-associated autoantibodies – anti-Ro60, anti-Ro52 and anti-La – measured in the study population.c.Dr. Scofield is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.d.ClinESSDAI is an endpoint specific to SjD and is a composite scale that assesses organ disease activity across 11 organ system domains [cutaneous, pulmonary, renal, articular, muscular, peripheral nervous system (PNS), central nervous system (CNS), hematological, glandular, constitutional, lymphadenopathy and lymphoma; a higher score indicates greater symptom severity.ABOUT DAHLIAS 
DAHLIAS (NCT04968912) is a Phase 2 multicenter, randomized, placebo-controlled double-blind, dose-ranging study to evaluate the effects of nipocalimab in participants with moderately-to-severely active primary Sjögren's disease (SjD) who were seropositive for anti-Ro60 and/or anti-Ro52 immunoglobulin G (IgG) antibodies. 163 adults aged 18-75 were randomized 1:1:1 to receive intravenous nipocalimab at 5 or 15 mg/kg, or placebo every 2 weeks through Week 22 and received protocol-permitted background standard of care. Safety assessments were conducted through Week 30. The primary endpoint was change in baseline in the ClinESSDAI (Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index) Score at Week 24. 4ABOUT SJÖGREN'S DISEASE 
Sjögren's disease (SjD) is one of the most prevalent autoantibody-driven diseases for which no therapies are currently approved that treat the underlying and systemic nature of the disease.5 It is a chronic autoimmune disease that is estimated to impact approximately four million people worldwide and is nine times more common in women than men.6 SjD is characterized by autoantibody production, chronic inflammation and lymphocytic infiltration of exocrine glands.7 Most patients are affected by mucosal dryness (eyes, mouth, vagina), joint pain and fatigue.8 More than 50% of SjD patients have a moderate-to-severe form of the condition, and disease burden can be as high as that of rheumatoid arthritis or systemic lupus erythematosus (SLE).9,10,11 It is usually associated with impaired quality of life, and in up to approximately half of patients, a loss of functional capacity that can result in an inability to work due to a disability.10,11,12ABOUT NIPOCALIMAB 
Nipocalimab is an investigational immunoselective treatment designed to target, bind with high affinity and block neonatal Fc receptor (FcRn), reducing circulating immunoglobulin (IgG) antibodies that drive disease while also preserving key immune functions.13,14 Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases andMaternal Fetal diseases mediated by maternal alloantibodies in which blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.4,15,16,17,18,19,20,21,22The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:??? EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025U.S. FDA Fast Track designation in HDFN and warm autoimmune hemolytic anemia (wAIHA) in July 2019, generalized myasthenia gravis (gMG) in December 2021, FNAIT in March 2024, Sjögren's disease (SjD) in March 2025 and systemic lupus erythematosus (SLE) in January 2026 U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024U.S. FDA granted Priority Review in gMG in Q4 2024 and wAIHA in Q2 2026ABOUT JOHNSON & JOHNSON 
At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated and cured,?where treatments are smarter and less invasive, and?solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.?? Learn more at?https://www.jnj.com/?or at?www.innovativemedicine.jnj.com. Follow us at?@JNJInnovMed.?? Janssen Biotech, Inc. is a Johnson & Johnson company.  Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of?Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in?Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in?Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from?Johnson & Johnson.?Johnson & Johnson?does not undertake to update any forward-looking statement as a result of new information or future events or developments. 1 Scofield, H et al. Biomarker-Driven Insights to Clinical Response in DAHLIAS: A Nipocalimab Trial for Sjogren's Disease. Presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress. Oral Presentation #OP0131
2 Noaiseh, G et al., Efficacy and safety of nipocalimab in patients with moderate-to-severe Sjögren's disease (DAHLIAS): a randomised, phase 2, placebo-controlled, double-blind trial. The Lancet. Oct 2025; Nov 22;406(10518):2435-2448.
3 Seth NP, et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. MAbs. 2025 Dec;17(1):2461191.
4 ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: June 2026.
5 Huang H, et al. Mortality in patients with primary Sjögren's syndrome: a systematic review and meta-analysis. Rheumatology (Oxford). 2021 Sep 1;60(9):4029-4038. doi: 10.1093/rheumatology/keab364. PMID: 33878179
6 Beydon, M., et al. Epidemiology of Sjögren syndrome. Nat Rev Rheumatol. 2024 Mar;20(3):158-169. doi: 10.1038/s41584-023-01057-6.
7 Meudec L, Nocturne G, Mariette X. Update on the Aetiopathogenesis of Sjögren Disease: From Interferon Signaling to Epithelial Dysfunction. J Clin Med. 2026 Mar 4;15(5):1945. doi: 10.3390/jcm15051945
8 Mayo Clinic. Sjogren's syndrome. Available at: https://www.mayoclinic.org/diseases-conditions/sjogrens-syndrome/symptoms-causes/syc-20353216. Last accessed: June 2026.
9 Lim ZFS, et al. Regulatory T cell therapy for Sjögren's disease: From pathogenesis to targeted treatment. J Transl Autoimmun. 2025 Aug 26;11:100311. doi: 10.1016/j.jtauto.2025.100311.
10 Carsons SE, Patel BC. Sjogren Syndrome. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK431049/
11 Hackett KL, et al. Impaired functional status in primary Sjögren's syndrome. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1760-4.
12 Meijer JM, et al. Health-related quality of life, employment and disability in patients with Sjogren's syndrome. Rheumatology (Oxford). 2009 Sep;48(9):1077-82. doi: 10.1093/rheumatology/kep141. Epub 2009 Jun 24. PMID: 19553376.
13 Ling LE., et al. M281, an anti–fcrn antibody: Pharmacodynamics, pharmacokinetics, and safety across the full range of IGG reduction in a first–in–human study. Clinical Pharmacology & Therapeutics., 2018;105;4:1031–1039. Available at: https://doi.org/10.1002/cpt.1276.
14 National Institute of Arthritis and Musculoskeletal and Skin Disease. (2022) Systemic Lupus Erythematosus (Lupus). https://www.niams.nih.gov/health-topics/lupus. Last accessed: June 2026.
15 ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622. Last accessed: June 2026.
16 ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: June 2026.
17 ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: June 2026.
18 ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: June 2026.
19 ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: June 2026.
20 ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: June 2026.
21 ClinicalTrials.gov Identifier: NCT06449651. Available at: https://clinicaltrials.gov/study/NCT06449651. Last accessed: June 2026.
22 ClinicalTrials.gov Identifier: NCT06533098 Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: June 2026.Media contact: Investor contact:Bridget KimmelJess MargevichBKimmel@ITS.JNJ.com Investor-relations@its.jnj.com View original content to download multimedia:https://www.prnewswire.com/news-releases/johnson--johnson-presents-new-data-further-reinforcing-the-role-of-nipocalimab-in-lowering-the-autoantibodies-driving-sjogrens-disease-302789435.htmlSOURCE Johnson & Johnson Original: Johnson & Johnson presents new data further reinforcing the role of nipocalimab in lowering the autoantibodies driving Sjögren's disease

Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 studyJune 3, 2026 12:04 AM
PR Newswire (US) Nipocalimab – the first and only neonatal Fc receptor (FcRn) blocker to be studied in systemic lupus erythematosus – is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with this disease while preserving immune functionResults demonstrated significant reduction of systemic lupus erythematosus disease activity which continued beyond the 24-week primary endpoint, and were sustained through Week 52 in the nipocalimab 15 mg/kg groupaThe ongoing Phase 3 study of nipocalimab is currently recruiting people living with systemic lupus erythematosus – a debilitating autoantibody-driven disease which can lead to systemic organ damageLONDON, June 3, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced nipocalimab met the primary endpoint of decreasing disease activity at 24 weeks as measured by SLE Responder Index 4 (SRI-4)b and continued to demonstrate sustained reduction in disease activity in adults with moderate-to-severe systemic lupus erythematosus (SLE)a through 52 weeks in the Phase 2 JASMINE study as measured by both SRI-4b and Lupus Low Disease Activity State (LLDAS).c In addition, the study results showed greater response versus placebo plus background medicationd in participants who tested positive for lupus-associated autoantibodies, which represents the vast majority (~80%) of people living with SLE.e,1 These findings will be featured in a late-breaking presentation at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London and are among the 38 abstracts the Company is presenting across its Rheumatology portfolio.  Nipocalimab is designed to selectively block the neonatal Fc receptor (FcRn), reducing levels of circulating pathogenic immunoglobulin (IgG) autoantibodies and immune complexes associated with inflammation in SLE.2,3 By reducing circulating IgG, including autoantibodies, nipocalimab is designed to target the underlying cause of disease while preserving critical immune functions.4 JASMINE is the first clinical study to demonstrate efficacy of FcRn blockade in SLE and provides clinical, biomarker and pharmacodynamic evidence supporting the continued investigation of nipocalimab as a potential treatment option for this disease.5A healthcare professional's perspective
"The consistent improvements observed across established disease activity measures and reductions in pathogenic immunoglobulin G autoantibodies are encouraging and support the continued investigation of nipocalimab as a targeted treatment approach for people living with systemic lupus erythematosus," said Richard Furie, M.D., Chief of the Division of Rheumatology at Northwell.f "These 52-week findings support the potential of nipocalimab to provide disease control over time for a broad population of autoantibody-positive adult patients living with moderate-to-severe systemic lupus erythematosus, a disease in which many patients experience ongoing disease activity and risk of irreversible organ damage."JASMINE Phase 2 clinical findings
The Phase 2 JASMINE study is the first proof-of-concept for a FcRn-blocker in SLE and demonstrates the potential of nipocalimab to reduce disease activity, with greater responses observed in autoantibody-positive patients.1,5The study met its primary endpoint at Week 24, with a greater proportion of patients receiving nipocalimab 15 mg/kg plus background medication achieving an SRI-4b response compared with placebo plus background medication (53.5% vs 46.7%). In a predefined autoantibody-positive patient populatione, greater SRI-4 response rates were observed (58.2% vs. 36.1%) and greater achievement of LLDAS (38.9% vs. 18.0%) compared with placebo plus background medication at Week 52.At Week 52, a key secondary endpoint, 53.6% of patients receiving nipocalimab 15 mg/kg achieved an SRI-4b response, compared with 39.7% for placebo plus background medication.More patients receiving nipocalimab 15 mg/kg also achieved LLDASc, a key exploratory endpoint that enables a treat-to-targetg approach, compared with placebo plus background medication (37.5% vs. 20.5%) at Week 52.Nipocalimab had a safety profile consistent with previous studies of nipocalimab and no new safety signals were identified. The most common adverse reactions in patients with SLE treated with nipocalimab (≥10%) were nasopharyngitis, headache, urinary tract infection and nausea.5"The JASMINE results provide important new insights into the potential of nipocalimab for adults with moderate-to-severe systemic lupus erythematosus as we continue advancing this program," said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson. "We are especially encouraged by the responses observed in autoantibody-positive study participants. These findings support the potential of nipocalimab as a targeted, immunoselective treatment designed to address underlying drivers of systemic lupus erythematosus." Nipocalimab received Fast Track Designation in SLE by the U.S. Food and Drug Administration (FDA) earlier this year. The ongoing Phase 3 GARDENIA study is currently recruiting.Editor's Notes: a. Nipocalimab is not FDA-approved for SLE. b. The SRI-4 is a composite measure used to assess treatment response in patients with SLE during clinical studies. It comprises criteria from three different internationally validated indices, SELENA-SLE Disease Activity Index (SELENA-SLEDAI), Physician Global Assessment (PGA) and the British Isles Lupus Assessment Group (BILAG) 2004.c. LLDAS definition: (1) SLE Disease Activity Index (SLEDAI)-2K ≤4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity; (2) no new lupus disease activity compared with the previous assessment; (3) a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI physician global assessment (scale 0-3) ≤1; (4) a current prednisolone (or equivalent) dose ≤7.5 mg daily; and (5) well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents. d. Protocol-permitted background medications include oral corticosteroids, antimalarials and no more than two of the following immunomodulatory drugs: azathioprine, mycophenolate mofetil, mycophenolic acid, oral methotrexate.e. The autoantibody-positive population was defined as participants who met ≥1 of the following during screening: (1) positive anti-double-stranded DNA (anti-dsDNA), (2) positive anti-Smith, (3) positive antinuclear antibodies (ANA) and positive for anti-Ro, anti-RNP or had a history of anti-dsDNA.f. Dr. Richard Furie has provided consulting, advisory and speaking services to?Johnson & Johnson. He has not been paid for any media work.g. Treat-to-target in SLE is a therapeutic strategy in which treatment is guided by regular assessment of disease activity and adjusted to achieve a predefined target – primarily remission, or low disease activity if remission is not attainable – to improve long-term outcomes and prevent organ damage.6ABOUT JASMINE
JASMINE (NCT04882878) is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate nipocalimab in 228 adult participants with active systemic lupus erythematosus (SLE). Adults aged 18-65 years with moderate-to-severe SLE, defined by established measures of disease activity, who were positive for antinuclear antibodies (ANA), anti-double-stranded DNA (anti-dsDNA), and/or anti-Smith antibodies, and had not responded to at least one standard-of-care treatment were enrolled. Participants were randomized 1:1:1 to receive intravenous nipocalimab at 5 or 15 mg/kg, or placebo every 2 weeks through Week 52, in addition to protocol-permitted background medications. The primary endpoint was the SLE Responder Index-4 (SRI-4) composite response at Week 24. Pharmacodynamic effects and safety, including adverse events, were assessed through Week 58.5ABOUT SYSTEMIC LUPUS ERYTHEMATOSUS
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that occurs when the body's immune system mistakenly attacks its own healthy tissues.7,8 This can lead to inflammation and damage in many parts of the body, including the skin, joints, heart, lungs, kidneys and brain.3 SLE affects nine times more women than men, often striking initially between the ages of 15-44.9 In addition to systemic organ damage, other complications of SLE can include end-stage renal failure, scarring cutaneous lesions, neurological damage and various forms of cardiovascular disease.3 People living with SLE often face reduced health-related quality of life, due to severe fatigue, mood disturbances, joint pain, swelling and rashes, including the hallmark butterfly-shaped facial rash, as well as complications of long-term glucocorticoid use.10 Severe fatigue is the most widely reported and debilitating symptom of SLE, affecting up to 80% of people with SLE.11 SLE is the most common form of lupus, affecting 3 to 5 million people worldwide, approximately 70% of lupus cases.12,13 It is estimated that 450,000 people in the United States are affected by SLE.14ABOUT NIPOCALIMAB 
Nipocalimab is an investigational immunoselective treatment designed to target, bind with high affinity, and block neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving key immune functions.2,3 Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic disease, Rare Autoantibody diseases and Maternal Fetal diseases mediated by maternal alloantibodies in which blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus. 5,15,16,17,18,19,20,21,22,23The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:?EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025 U.S. FDA Fast Track designation in HDFN and warm autoimmune hemolytic anemia (wAIHA) in July 2019, generalized myasthenia gravis (gMG) in December 2021, FNAIT in March 2024, Sjögren's disease (SjD) in March 2025 and systemic lupus erythematosus (SLE) in January 2026 U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023 U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024 U.S. FDA granted Priority Review in gMG in Q4 2024 and in wAIHA in Q2 2026 ABOUT JOHNSON & JOHNSON 
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.Learn more at?https://www.jnj.com/?or at?www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.?Janssen Biotech, Inc. is a?Johnson & Johnson?company.? Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. 1 Richard A Furie, Ronald van Vollenhoven, Rafal Wojciechowski, Eric Morand, Guillermo J. Pons-Estel, George A Karpouzas, Bart van Hartingsveldt, Robert W Hoffman, Terence Rooney, Sheng Gao, Robert Gordon, Kim Hung Lo, Jocelyn H. Leu, Federico Zazzetti, Stanley J. Marciniak, Steven Leonardo, Keying Ma, Kathy Sivils, Leonard Dragone, Loqmane Seridi, Linda Okonkwo, Erika Noss, Fang Liu-Walsh, Michelle Petri. Nipocalimab in SLE: First-in-class efficacy and safety results demonstrating proof of concept for FcRn blockade from the Phase 2 JASMINE-SLE study. Presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress.
2 Ling LE., et al. M281, an anti–fcrn antibody: Pharmacodynamics, pharmacokinetics, and safety across the full range of IGG reduction in a first–in–human study. Clinical Pharmacology & Therapeutics., 2018;105;4:1031–1039. Available at: https://doi.org/10.1002/cpt.1276.
3 National Institute of Arthritis and Musculoskeletal and Skin Disease. (2022) Systemic Lupus Erythematosus (Lupus). https://www.niams.nih.gov/health-topics/lupus. Last accessed: April 2026.
4 Cossu M et al. A randomized, open-label study on the effect of nipocalimab vaccine response in healthy participants. Presentation at American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. October 2024.
5 ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: June 2026
6 Bracalenti M, Iaccarino L, Doria A. Remission and low disease activity in systemic lupus erythematosus. Rare Dis Orphan Drugs J. 2025;4:28. https://dx.doi.org/10.20517/rdodj.2025.10
7 Lupus Foundation of America. Understanding Lupus https://www.lupus.org/understanding-lupus. Last accessed: June 2026.
8 Kawka L, et al. Fatigue in Systemic Lupus Erythematosus: An Update on Its Impact, Determinants and Therapeutic Management. J Clin Med. 2021 Sep 3;10(17):3996. doi: 10.3390/jcm10173996. PMID: 34501444; PMCID: PMC8432566.
9 Guéry JC. Why Is Systemic Lupus Erythematosus More Common in Women? Joint Bone Spine. 2019 May;86(3):297-299. doi: 10.1016/j.jbspin.2018.12.004. Epub 2018 Dec 22. PMID: 30584922.
10 Centers for Disease Control and Prevention. (2024). Symptoms of lupus. https://www.cdc.gov/lupus/signs-symptoms/. Last accessed: June 2026.
11 Lupus Foundation of America. Understanding the Invisible Impact of Lupus. Available at: https://www.lupus.org/resources/understanding-the-invisible-impact-of-lupus. Last accessed: June 2026.
12 Tian, J., Zhang, D., Yao, X., Huang, Y., & Lu, Q. (2023). Global epidemiology of systemic lupus erythematosus: A comprehensive systematic analysis and modelling study. Annals of the Rheumatic Diseases, 82(3), 351–356. https://doi.org/10.1136/ard-2022-223035
13 Lupus Foundation of America. Lupus facts and statistics. https://www.lupus.org/resources/lupus-facts-and-statistics. Last accessed: June 2026.
14 Wang, Y., Hester, L. L., Lofland, J., Rose, S., Karyekar, C.S., Kern, D.M., Blacketer, M., Davis, K., & Sheilds-Tuttle, K. (2022). Update on the prevalence of diagnosed systemic lupus erythematosus (SLE) by major health insurance types in the US in 2016. BMC Research Notes, 15, 5. https://doi.org/10.1186/s13104-021-05877-1
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16 ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: June 2026.
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23 ClinicalTrials.gov Identifier: NCT06533098 Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: June 2026.Media contact:
Bridget KimmelBKimmel@ITS.JNJ.com  Investor contact:
Jess MargevichInvestor-relations@its.jnj.com    View original content to download multimedia:https://www.prnewswire.com/news-releases/johnson--johnson-late-breaking-results-show-nipocalimab-significantly-reduced-systemic-lupus-erythematosus-sle-disease-activity-in-a-phase-2-study-302789438.htmlSOURCE Johnson & Johnson Original: Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study

RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) pivotal data show strong and durable responses in advanced head and neck cancer where options remain limitedMay 31, 2026 8:29 AM
PR Newswire (US) More than one-third of responders with previously treated disease achieved complete responses, with median duration of response not yet reached, as reported in new Journal of Clinical Oncology publication RYBREVANT FASPRO™, an EGFR- and MET-targeting dual inhibitor, is the first and only subcutaneous therapy being evaluated in this setting Johnson & Johnson submitted a supplemental Biologics License Application to U.S. FDA seeking approval for this indication CHICAGO, May 31, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced pivotal results from the Phase 1b/2 OrigAMI-4 study showing that subcutaneous amivantamab and hyaluronidase-lpuj delivered durable responses in patients with advanced head and neck squamous cell carcinoma previously treated with immunotherapy and chemotherapy. Confirmed overall response rate was 42 percent, with more than one-third of responders achieving complete responses. Median duration of response was not yet reached, with a median follow up of 11.8 months.1 These data were featured in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #6008) and simultaneously published in the Journal of Clinical Oncology (JCO).2 Together, with additional data presented in lung and colorectal cancers, these findings further demonstrate the expanding role of the amivantamab portfolio across tumor types. A supplemental Biologics License Application (sBLA) seeking approval for subcutaneous amivantamab in head and neck cancer has been submitted to the U.S. Food and Drug Administration (FDA), following Breakthrough Therapy Designation.High unmet need remains in advanced head and neck cancerHead and neck squamous cell carcinoma is an aggressive disease that can significantly affect quality of life, with symptoms such as pain and difficulty swallowing that can make it hard to eat, speak and maintain proper nutrition.3,4 Certain forms of head and neck cancer, including tumors of the mouth, voice box and parts of the throat, are among the most difficult to treat, and are associated with poorer outcomes and persistent unmet need.5 Across head and neck cancers, up to half of patients will experience recurrence or metastatic disease, even when treated at an early stage.3 Once the disease becomes recurrent or metastatic, five-year survival is approximately 15 percent.6 For patients who receive additional treatment, current options provide limited benefit with response rates rarely exceeding 24 percent, and few patients achieve a complete response.7,8Dual-targeting mechanism helps address tumor growth and resistanceSubcutaneous amivantamab is designed to dual target both epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET), two pathways associated with tumor growth and resistance, while engaging the immune system.9"Patients with recurrent or metastatic head and neck cancer who have already been treated with immunotherapy and chemotherapy face very poor outcomes," said Barbara Burtness, M.D.,* medical oncologist and professor of medicine at Yale Cancer Center in New Haven, Connecticut. "The high response seen with subcutaneous amivantamab on its own, including more than one-third of responders achieving complete responses, and the durability of those responses, suggests it has the potential to meaningfully improve expectations for these patients."Detailed OrigAMI-4 study resultsCohort 1 of the OrigAMI-4 study evaluated subcutaneous amivantamab monotherapy in 102 patients with recurrent or metastatic head and neck cancer who had previously received immunotherapy and platinum-based chemotherapy, excluding patients with human papillomavirus (HPV)-positive oropharyngeal cancer. Patients received treatment every three weeks following an initial loading dose. The primary endpoint was overall response rate, as assessed by local investigators per protocol. Responses were confirmed via blinded independent central review (BICR).1 Based on BICR, confirmed overall response rate was 42 percent (95 percent confidence interval [CI], 32-52), including complete responses in more than one-third of responders (15 percent) and a 27 percent partial response rate. Clinical benefit rate was 63 percent (95 percent CI, 53-72), and median time to first response was 6.6 weeks (range, 5.6-36.9). At the time of analysis (median follow-up of 11.8 months), median duration of response had not yet been reached among confirmed responders, demonstrating notable durability. Median progression-free survival and overall survival were 6.8 months and 12.5 months, respectively.1The safety profile of subcutaneous amivantamab monotherapy was consistent with prior reports, with no new safety signals identified. Most treatment-related adverse events were Grade 1 or 2 (mild to moderate) and associated with EGFR or MET inhibition. The most common on-target adverse events included hypoalbuminemia (50 percent), rash (37 percent), paronychia (34 percent) and dermatitis acneiform (34 percent). Administration-related reactions occurred in 15 percent of patients, with no Grade 3 or higher events reported. Treatment-related discontinuations remained low at eight percent.1"Progress has been limited for patients with recurrent and metastatic head and neck cancer, highlighting the need for differentiated approaches that can address the disease more comprehensively," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "Subcutaneous amivantamab is the only therapy of its kind being studied in this disease, targeting both EGFR and MET while engaging the immune system. The encouraging responses we're seeing in OrigAMI-4, along with a well-established and manageable safety profile, underscore the potential of this approach and move us closer to delivering a fast, convenient treatment option."Ongoing study of RYBREVANT FASPRO™ in head and neck cancerA trial-in-progress update from the Phase 3 OrigAMI-5 study (NCT07276399) was also shared at ASCO 2026 (Abstract #583a). The study is evaluating subcutaneous amivantamab in combination with carboplatin and pembrolizumab as a first-line treatment for patients with recurrent or metastatic head and neck cancer, with the goal of improving outcomes in the first-line setting.10RYBREVANT FASPRO™ is already approved in more than 40 countries, including the United States, Europe, Japan, and other markets, as a subcutaneous treatment for patients with EGFR-mutated non-small cell lung cancer.11About the OrigAMI-4 StudyOrigAMI-4 (NCT06385080) is an open-label Phase 1b/2 study evaluating RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The study includes five cohorts exploring RYBREVANT FASPRO™ across different treatment settings and regimens.Cohort 1 evaluated RYBREVANT FASPRO™ as monotherapy in patients with R/M HNSCC who had received prior platinum-based chemotherapy and PD-1/PD-L1 immunotherapy. Patients with HPV-positive oropharyngeal squamous cell carcinoma were excluded, as well as those with prior anti-EGFR therapy.RYBREVANT FASPRO™ was administered on a weekly schedule during the initial treatment period followed by dosing every three weeks (Q3W), with weight-based dosing adjustments. The primary endpoint across cohorts is overall response rate (ORR), as assessed by investigators, using RECIST v1.1.†12About Head and Neck Squamous Cell Carcinoma Head and neck squamous cell carcinoma (HNSCC) is the most common form of head and neck cancer, a group of cancers that arise in the mouth, throat, voice box, sinuses, nasal cavity, and salivary glands.13 It represents approximately 4.5 percent of all cancers worldwide and is the seventh most common cancer globally.13 Major risk factors include tobacco and alcohol use, as well as infection with high-risk human papillomavirus (HPV).13 Approximately 80 percent of recurrent or metastatic HNSCC are not driven by HPV, and are typically associated with poorer prognosis and reduced response to treatment.13, 14 Despite advances in surgery, radiation, chemotherapy, and immunotherapy, many patients ultimately progress to advanced, recurrent or metastatic disease.15,16About RYBREVANT FASPRO™ and RYBREVANT®RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved in these populations and can be used as monotherapy or in combination with LAZCLUZE® (lazertinib) or chemotherapy in the front- and second-line settings, offering convenient monthly‡ or bi-weekly dosing. RYBREVANT FASPRO™ is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.RYBREVANT® (amivantamab-vmjw), administered intravenously, received U.S. FDA approval in March 2024 and is approved for the same indications as RYBREVANT FASPRO™ across multiple markets. RYBREVANT® is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system.The effectiveness of RYBREVANT FASPRO™ is supported by the established clinical profile of RYBREVANT®, including data from multiple Phase 3 studies such as MARIPOSA, which demonstrated improvements in progression-free and overall survival when used in combination with LAZCLUZE® in first-line advanced EGFR-mutated NSCLC.The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)§17 include amivantamab-vmjw (RYBREVANT®) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE®) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO™) may be substituted for IV amivantamab-vmjw (RYBREVANT®) where appropriate. See the latest NCCN Guidelines® for NSCLC for complete information. || The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT®)-based regimens, including in combination with lazertinib (LAZCLUZE®), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases. || Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers.The legal manufacturer for RYBREVANT FASPRO™ and RYBREVANT® is Janssen Biotech, Inc. For more information, visit www.rybrevanthcp.comINDICATIONSRYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) and RYBREVANT® (amivantamab-vmjw) are indicated:in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.IMPORTANT SAFETY INFORMATION FOR RYBREVANT FASPRO™ AND RYBREVANT® 10,18CONTRAINDICATIONSRYBREVANT FASPRO™ is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.WARNINGS AND PRECAUTIONS Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO™ RYBREVANT FASPRO™ can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3 (n=206), all Grade ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1).Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO™ as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO™ injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO™ based on severity.Infusion-Related Reactions with RYBREVANT®RYBREVANT® can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.RYBREVANT® with LAZCLUZE®In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT® in 4.5% of patients.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT® in 2.8% of patients.RYBREVANT® as a Single AgentIn CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT® in 1.3% of patients.Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT® as recommended. Administer RYBREVANT® via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT® based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT®.Interstitial Lung Disease/Pneumonitis RYBREVANT FASPRO™ and RYBREVANT® can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO™ and LAZCLUZE® due to ILD/pneumonitis.RYBREVANT® with LAZCLUZE®In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT® and LAZCLUZE® due to ILD/pneumonitis.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT® due to ILD/pneumonitis.RYBREVANT® as a Single AgentIn CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT® due to ILD/pneumonitis.Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE®RYBREVANT FASPRO™ and RYBREVANT® in combination with LAZCLUZE® can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO™ and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).RYBREVANT® with LAZCLUZE®In MARIPOSA (n=421), VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT®, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE®; 1% of patients had VTE leading to dose reductions of RYBREVANT®, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE®; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT®, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE®. The median time to onset of VTEs was 84 days (range: 6 to 777).Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO™ or RYBREVANT®. Treatment can continue with LAZCLUZE® at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE® Prescribing Information for recommended LAZCLUZE® dosage modification.Dermatologic Adverse ReactionsRYBREVANT FASPRO™ and RYBREVANT® can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO™ was permanently discontinued due to rash in 1.5% of patients.RYBREVANT® with LAZCLUZE®In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT® and 30% for LAZCLUZE®, rash leading to dose reductions occurred in 23% of patients for RYBREVANT® and 19% for LAZCLUZE®, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT® and 1.7% for LAZCLUZE®.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT® and 3.1% discontinued pemetrexed.RYBREVANT® as a Single AgentIn CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%). When initiating treatment with RYBREVANT FASPRO or RYBREVANT and LAZCLUZE, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen.If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO™ or RYBREVANT® in combination with LAZCLUZE®, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO™ or RYBREVANT® as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT® based on severity.HepatotoxicityLAZCLUZE® in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST).RYBREVANT® with LAZCLUZE®In MARIPOSA, based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE®, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%. LAZCLUZE® was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%.Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE® and during treatment, as clinically indicated. Withhold, reduce the dose, or permanently discontinue LAZCLUZE® and amivantamab based on severity.Ocular ToxicityRYBREVANT FASPRO™ and RYBREVANT® can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3.RYBREVANT® with LAZCLUZE®In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2.RYBREVANT® as a Single AgentIn CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2.Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT® and continue LAZCLUZE® based on severity.Embryo-Fetal ToxicityBased on animal models, RYBREVANT FASPRO™, RYBREVANT® and LAZCLUZE® can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO™ and RYBREVANT®. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO™ or RYBREVANT®, and for 3 weeks after the last dose of LAZCLUZE®.ADVERSE REACTIONSRYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3 (n=206), the most common adverse reactions (≥20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gamma-glutamyl transferase (2%), and decreased hemoglobin (2%).Serious adverse reactions occurred in 33% of patients, with those occurring in ≥2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO™, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).RYBREVANT® with LAZCLUZE®In MARIPOSA (n=421), the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT®) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT®) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).RYBREVANT® with Carboplatin and PemetrexedIn MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.RYBREVANT® as a Single AgentIn CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.LAZCLUZE® DRUG INTERACTIONSAvoid concomitant use of LAZCLUZE® with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.Please see full Prescribing Information for RYBREVANT FASPRO™, RYBREVANT® and LAZCLUZE®.cp-491009v2About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of RYBREVANT®-based regimens. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.*Barbara Burtness, M.D. has served as a consultant to Johnson & Johnson; she has not been paid for any media work. † RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger.‡ Once monthly after weekly injections from weeks 1-4.§ The NCCN content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.|| See the NCCN Guidelines for detailed recommendations, including other treatment options. The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.1 Burtness B, et al. Amivantamab in recurrent/metastatic head & neck squamous cell cancer after disease progression on immune checkpoint inhibitor and chemotherapy. Pivotal results from the phase 1b/2 OrigAMI-4 study. Presented at: The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31, 2026; Chicago, Illinois.
2 Burtness B, et al. Amivantamab in recurrent/metastatic HNSCC after checkpoint inhibitor and chemotherapy: pivotal results from the phase 1b/2 OrigAMI-4 study. Epub May 31, 2026. doi:10.1200/JCO-26-01042.
3 Zebralla V, Wichmann G, Pirlich M, et al. Dysphagia, voice problems, and pain in head and neck cancer patients. Eur Arch Otorhinolaryngol. 2021;278(10):3985-3994. doi:10.1007/s00405-020-06584-6
4 Nissi L, et al. Recurrence of head and neck squamous cell carcinoma in relation to high-risk treatment volume. Clin Transl Radiat Oncol. 2021;27:139-146. doi:10.1016/j.ctro.2021.01.013
5 Dunn LA, Ho AL, Pfister DG. Head and neck cancer: a review. JAMA. 2026;335(6):531-541. doi:10.1001/jama.2025.21733
6 Soulieres D, et al. LBA48 BURAN: A phase III study of buparlisib (BUP) plus paclitaxel (PAC) in patients with PD-1(PD-L1)-pretreated recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Ann Oncol. 2025;36:S1707.
7 Fayette J, et al. INTERLINK-1: A Phase III, randomized, placebo-controlled study of monalizumab plus cetuximab in recurrent/metastatic head and neck squamous cell carcinoma. Clin Cancer Res. 2025;31(13):2617-2627. doi:10.1158/1078-0432.CCR-25-0073
8 Große-Thie C, Maletzki C, Junghanss C, Schmidt K. Long-term survivor of metastatic squamous-cell head and neck carcinoma with occult primary after cetuximab-based chemotherapy: A case report. World J Clin Cases. 2021;9(24):7092-7098. doi:10.12998/wjcc.v9.i24.7092
9 Harrington KJ, Rosenberg AJ, Yang MH, et al. Subcutaneous amivantamab in recurrent/metastatic head and neck squamous cell cancer after disease progression on checkpoint inhibitor and chemotherapy: Preliminary results from the phase 1b/2 OrigAMI-4 study. Oral Oncol. 2025;171:107791. doi:10.1016/j.oraloncology.2025.107791
10 Haddad R, et al. OrigAMI-5: A randomized, phase 3 study of amivantamab plus pembrolizumab and carboplatin vs standard of care pembrolizumab plus platinum and 5-fluorouracil as first-line treatment in recurrent/metastatic head and neck cancer. Presented at: The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30, 2026; Chicago, Illinois.
11 RYBREVANT FASPRO™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
12 ClinicalTrials.gov. A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/ Metastatic Head and Neck Cancer (OrigAMI-4). https://clinicaltrials.gov/study/NCT06385080?term=OrigAMI-4&limit=10&rank=1. Accessed May 2026.
13 Barsouk A, Aluru JS, Rawla P, Saginala K, Barsouk A. Epidemiology, Risk Factors, and Prevention of Head and Neck Squamous Cell Carcinoma. Med Sci (Basel). 2023;11(2):42. Published 2023 Jun 13. doi:10.3390/medsci11020042
14 Ghiani L, Chiocca S. High Risk-Human Papillomavirus in HNSCC: Present and Future Challenges for Epigenetic Therapies. International Journal of Molecular Sciences. 2022;23(7):3483. https://doi.org/10.3390/ijms23073483
15 Ferris RL, Blumenschein G Jr, Fayette J, et al. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. New England Journal of Medicine. 2016;375(19):1856-1867. doi:10.1056/NEJMoa1602252
16 Wise-Draper TM, Bahig H, Tonneau M, Karivedu V, Burtness B. Current Therapy for Metastatic Head and Neck Cancer: Evidence, Opportunities, and Challenges. Am Soc Clin Oncol Educ Book. 2022;42:1-14. doi:10.1200/EDBK_350442
17 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2026 © National Comprehensive Cancer Network, Inc. All rights reserved. To view the most recent and complete version of the guideline, go online to NCCN.org. Accessed May 2026.
18 RYBREVANT® Prescribing Information. Horsham, PA: Janssen Biotech, Inc.Media contact:
Oncology Media Relations
oncology_media_relations@its.jnj.comInvestor contact:
Jess Margevich 
investor-relations@its.jnj.com 


U.S. Medical Inquiries: 
+1 800 526-7736  View original content to download multimedia:https://www.prnewswire.com/news-releases/rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-pivotal-data-show-strong-and-durable-responses-in-advanced-head-and-neck-cancer-where-options-remain-limited-302786430.htmlSOURCE Johnson & Johnson Original: RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) pivotal data show strong and durable responses in advanced head and neck cancer where options remain limited

Johnson & Johnson's Phase 3 prostate cancer study shows ERLEADA® (apalutamide) before and after surgery significantly reduces risk of metastasis or death, breaking a decades-long treatment paradigmMay 31, 2026 8:27 AM
PR Newswire (US) Patients were nine times more likely to have little to no cancer remaining in the prostate after surgery, with a 20% reduction in the risk of developing metastasis or death Data selected to open the plenary presentation at ASCO 2026 and published in The New England Journal of MedicineCHICAGO, May 31, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced results from the final analysis of the Phase 3 PROTEUS study showing the investigational use of apalutamide plus hormone therapy (androgen deprivation therapy, ADT), given for six months before and after prostate cancer surgery, significantly improved key short- and long-term clinical outcomes for patients with high-risk localized or locally advanced disease. The trial met both primary endpoints. Patients treated with apalutamide plus hormone therapy were nine times more likely to have little to no cancer remaining at the time of surgery compared with hormone therapy alone (8.9 percent vs. 1.0 percent; pathologic complete response/minimal residual disease). The combination also reduced the risk of developing metastasis or death by 20 percent and extended the time before patients required subsequent therapy to more than six years. These findings will be presented in a plenary session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Oral Abstract #LBA1) and published simultaneously in The New England Journal of Medicine.1,2 The unmet need with standard treatments for patients with high-risk localized prostate cancerSurgery to remove the prostate (radical prostatectomy) is one of the standard treatments for patients with high-risk localized or locally advanced disease, alongside radiation therapy.3,4 Yet nearly half of patients who undergo curative-intent surgery will see their cancer return, requiring additional treatment and moving beyond the point where cure is possible.5,6,7 Additional therapies are often used only after the cancer has spread, missing a critical window to intervene earlier and improve long-term outcomes.8 Apalutamide blocks androgen hormones from binding to their receptor, which can help slow prostate cancer progression. It is currently approved for use in advanced prostate cancer, including cases where the disease has spread (metastatic castration-sensitive) or is no longer responding to certain hormone therapies (non-metastatic castration-resistant prostate cancer).9Expert perspectives on the perioperative use of ERLEADA® plus hormone therapy six months before and after prostate cancer surgery"Reducing the risk of prostate cancer recurrence and death with improved initial treatment regimens has been a longstanding unmet need for patients with localized high-risk prostate cancer," said Mary-Ellen Taplin,* M.D., FASCO, medical oncologist at Dana-Farber Cancer Institute and Harvard Medical School, and principal investigator. "The PROTEUS trial demonstrates that adding preoperative apalutamide to androgen deprivation therapy and surgery reduced the risk of metastases or death by 20 percent. This result is most impactful as it may reduce the need for subsequent therapies and related side effects, while also increasing potential cure rates. This approach, which combines systemic therapy with surgery, is already standard in other aggressive cancers and now has proven benefit in patients with this disease.""For decades, surgery has been the standard approach for many patients with high-risk localized or locally advanced prostate cancer, but these data suggest it may not be enough on its own," said Adam Kibel,† M.D., urologic surgeon and chair of the Department of Urology at Mass General Brigham. "Earlier integration of apalutamide has the potential to reshape how prostate cancer is treated by building on curative-intent surgical treatment and improving outcomes for these patients."Detailed PROTEUS study resultsPROTEUS is a Phase 3 study evaluating apalutamide, an androgen receptor pathway inhibitor, combined with hormone therapy before and after surgery in patients with newly diagnosed high-risk localized or locally advanced prostate cancer (n=2109). The dual primary endpoints were the amount of cancer remaining at surgery (pathologic complete response/minimal residual disease, pCR/MRD) and how long patients lived without the cancer spreading (metastasis-free survival, MFS), both assessed by blinded independent central review.1At a median follow-up of 61.7 months, apalutamide plus hormone therapy met both primary endpoints. The rate of pCR/MRD was 8.9 percent with apalutamide plus hormone therapy versus 1.0 percent with hormone therapy alone (odds ratio [OR], 10.17; 95 percent confidence interval [CI], 5.27-19.64; p

RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) demonstrates prolonged clinical benefit as a first-line treatment for atypical EGFR-mutated non-small cell lung cancerMay 29, 2026 2:00 PM
PR Newswire (US) Median overall survival, a secondary endpoint, reached nearly 3.5 years with Johnson & Johnson's RYBREVANT® plus LAZCLUZE® in atypical EGFR-mutated diseaseConsistent responses observed across atypical EGFR mutation subgroups, including those historically associated with poorer outcomesASCO 2026 results reinforce the significance of RYBREVANT®-based regimens for patients across EGFR mutationsCHICAGO, May 29, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced updated results from the Phase 1/1b CHRYSALIS-2 study evaluating intravenous RYBREVANT® (amivantamab-vmjw) in combination with LAZCLUZE® (lazertinib) in patients with advanced non-small cell lung cancer (NSCLC) with atypical epidermal growth factor receptor (EGFR) mutations. The analysis showed encouraging long-term outcomes with RYBREVANT® plus LAZCLUZE® in this difficult-to-treat population. Median overall survival, a secondary endpoint, was nearly 3.5 years.1 The primary endpoint of objective response rate was previously reported.2 These results add to the growing body of evidence demonstrating the potential of RYBREVANT® plus LAZCLUZE® to deliver durable survival outcomes across both common and atypical EGFR-mutated advanced NSCLC in the first-line setting. Data were presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8501).1 Significant unmet need in patients with atypical EGFR-mutated NSCLCPatients with atypical EGFR-mutated NSCLC tend to have poorer outcomes than those with common EGFR mutations (exon 19 deletions and L858R substitutions), and effective first-line treatment options remain limited.3,4 These mutations represent approximately 10-20 percent of all EGFR-mutated cases.5 Median overall survival with current standard of care single-agent therapies remains under two years, highlighting a significant unmet need for treatments that can deliver more durable benefit in this setting.6,7 RYBREVANT® is designed to dual target EGFR and mesenchymal-epithelial transition (MET), while engaging the immune system.8,9,10,11 These complementary mechanisms play a central role in tumor growth and treatment resistance and may help address the underlying drivers of disease.Expert and company perspectives supporting the strength of RYBREVANT® plus LAZCLUZE®"For patients with non-small cell lung cancer harboring atypical EGFR-mutations, first-line treatment decisions are often clouded by uncertainty regarding the efficacy of currently available EGFR tyrosine kinase inhibitors," said Joel Neal,* M.D., Ph.D., principal investigator of the Phase 1/1b CHRYSALIS-2 study. "The responses we've seen in this trial suggest the potential for more durable disease control, and the overall survival data reinforce that picture. These long-term outcomes begin to change how we think about treatment options in managing this subtype of lung cancer." Neal is also a Professor of Medicine in the Division of Oncology at Stanford Medicine."Disease progression and molecular resistance remain critical barriers in EGFR-mutated non-small cell lung cancer," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "RYBREVANT-based combinations demonstrate the power of changing the biology by addressing multiple disease drivers from the start rather than relying on single-pathway strategies. With strong outcomes across all known EGFR mutations, this approach is raising the bar for what first-line treatment can achieve."Detailed CHRYSALIS-2 study resultsIn Cohort C of the CHRYSALIS-2 study, RYBREVANT® plus LAZCLUZE® was evaluated as a first-line treatment in patients with atypical EGFR-mutated advanced NSCLC, excluding EGFR exon 20 insertion mutations (n=49). The most common atypical EGFR mutations included G719X (55 percent), S768X (27 percent) and L861X (24 percent), with 35 percent of patients harboring multiple atypical mutations. The study previously reported an objective response rate of 57 percent (primary endpoint).1,2Median overall survival with RYBREVANT® plus LAZCLUZE® reached nearly 3.5 years (41.0 months; 95 percent confidence interval [CI], 27.7-not estimable) at a median follow-up of 31.3 months. Overall survival rates were 55 percent at three years and 46 percent at four years.1Consistent clinical activity was observed across atypical EGFR mutation subgroups, as well as across patient and disease characteristics such as central nervous system metastases and TP53 status. Patients were also able to remain on treatment long-term across mutation groups and baseline characteristics. Notably, 41 percent of patients remained on RYBREVANT® for two years or longer, further supporting the durable survival observed with this combination.1The safety profile of RYBREVANT® plus LAZCLUZE® was consistent with previous reports, with no new safety signals observed with longer follow-up. Most adverse events were Grade 1 or 2. The most common treatment-emergent adverse events occurring in more than 30 percent of patients included paronychia (78 percent), rash (65 percent), hypoalbuminemia (61 percent) and infusion-related reactions (61 percent).1RYBREVANT®-based regimens are approved for patients with EGFR-mutated advanced NSCLC across common (exon 19 deletions and exon 21 L858R substitution mutations) and exon 20 insertion mutations, including in the first-line setting.12 These results further define long-term outcomes with first-line RYBREVANT® plus LAZCLUZE® for patients with atypical EGFR mutations. Additional data being presented at ASCO 2026 in lung, head and neck, and colorectal cancers underscore the broader potential of RYBREVANT® across tumor types.About the CHRYSALIS-2 StudyCHRYSALIS-2 (NCT04077463) is an open-label Phase 1/1b study to evaluate the safety and pharmacokinetics of LAZCLUZE®, a third-generation EGFR-TKI, as monotherapy or in combinations with RYBREVANT®, a human bispecific EGFR and cMet antibody in participants with advanced NSCLC. The study enrolled 460 patients with advanced NSCLC.13Cohort C of the ongoing CHRYSALIS-2 study evaluates patients with atypical EGFR-mutated advanced NSCLC, excluding exon 20 insertion and classical EGFR mutations, who are treatment-naïve or have received up to two prior lines of therapy. Patients received intravenous RYBREVANT® in combination with LAZCLUZE® administered orally once daily.13About Non-Small Cell Lung Cancer Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases.14,15 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.16 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.17 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients.14,15,18,19,20,21 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations.22 The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors (TKIs) is less than 20 percent.23,24 EGFR exon 20 insertion mutations are the third-most prevalent activating EGFR mutation.25 Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (OS) of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent.26About RYBREVANT®RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved in these populations and can be used as monotherapy or in combination with LAZCLUZE® (lazertinib) or chemotherapy in the front- and second-line settings, offering convenient monthly† or bi-weekly dosing. RYBREVANT FASPRO™ is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.RYBREVANT® (amivantamab-vmjw), administered intravenously, received U.S. FDA approval in March 2024 and is approved for the same indications as RYBREVANT FASPRO™ across multiple markets. RYBERVANT® is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system.The effectiveness of RYBREVANT FASPRO™ is supported by the established clinical profile of RYBREVANT®, including data from multiple Phase 3 studies such as MARIPOSA, which demonstrated improvements in progression-free and overall survival when used in combination with LAZCLUZE® in first-line advanced EGFR-mutated NSCLC.The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)‡ 27 include amivantamab-vmjw (RYBREVANT®) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE®) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO™) may be substituted for IV amivantamab-vmjw (RYBREVANT®) where appropriate. See the latest NCCN Guidelines® for NSCLC for complete information.§ ||The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT®)-based regimens, including in combination with lazertinib (LAZCLUZE®), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.§ ||Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers.The legal manufacturer for RYBREVANT® is Janssen Biotech, Inc. For more information, visit www.rybrevanthcp.com.About LAZCLUZE®In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE® (marketed as LECLAZA in South Korea). LAZCLUZE® is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. An analysis of the efficacy and safety of LAZCLUZE® from the Phase 3 LASER301 study was published in The Journal of Clinical Oncology in 2023.28The legal manufacturer for LAZCLUZE® is Janssen Biotech, Inc. and Yuhan Corporation.INDICATIONSRYBREVANT® (amivantamab-vmjw) is indicated:in combination with LAZCLUZE® (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.IMPORTANT SAFETY INFORMATION FOR RYBREVANT FASPRO™ AND RYBREVANT® 12,29CONTRAINDICATIONSRYBREVANT FASPRO™ is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.WARNINGS AND PRECAUTIONS Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO™ RYBREVANT FASPRO™ can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3 (n=206), all Grade ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1).Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO™ as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO™ injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO™ based on severity.Infusion-Related Reactions with RYBREVANT®RYBREVANT® can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.RYBREVANT® with LAZCLUZE®In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT® in 4.5% of patients.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT® in 2.8% of patients.RYBREVANT® as a Single AgentIn CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT® in 1.3% of patients.Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT® as recommended. Administer RYBREVANT® via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT® based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT®.Interstitial Lung Disease/Pneumonitis RYBREVANT FASPRO™ and RYBREVANT® can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO™ and LAZCLUZE® due to ILD/pneumonitis.RYBREVANT® with LAZCLUZE®In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT® and LAZCLUZE® due to ILD/pneumonitis.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT® due to ILD/pneumonitis.RYBREVANT® as a Single AgentIn CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT® due to ILD/pneumonitis.Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE®RYBREVANT FASPRO™ and RYBREVANT® in combination with LAZCLUZE® can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO™ and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).RYBREVANT® with LAZCLUZE®In MARIPOSA (n=421), VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT®, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE®; 1% of patients had VTE leading to dose reductions of RYBREVANT®, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE®; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT®, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE®. The median time to onset of VTEs was 84 days (range: 6 to 777).Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO™ or RYBREVANT®. Treatment can continue with LAZCLUZE® at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE® Prescribing Information for recommended LAZCLUZE® dosage modification.Dermatologic Adverse ReactionsRYBREVANT FASPRO™ and RYBREVANT® can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO™ was permanently discontinued due to rash in 1.5% of patients.RYBREVANT® with LAZCLUZE®In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT® and 30% for LAZCLUZE®, rash leading to dose reductions occurred in 23% of patients for RYBREVANT® and 19% for LAZCLUZE®, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT® and 1.7% for LAZCLUZE®.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT® and 3.1% discontinued pemetrexed.RYBREVANT® as a Single AgentIn CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%).When initiating treatment with RYBREVANT FASPRO or RYBREVANT and LAZCLUZE, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen.If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO™ or RYBREVANT® in combination with LAZCLUZE®, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO™ or RYBREVANT® as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT® based on severityHepatotoxicityLAZCLUZE® in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST).RYBREVANT® with LAZCLUZE®In MARIPOSA, based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE®, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%. LAZCLUZE® was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%.Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE® and during treatment, as clinically indicated. Withhold, reduce the dose, or permanently discontinue LAZCLUZE® and amivantamab based on severity.Ocular ToxicityRYBREVANT FASPRO™ and RYBREVANT® can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3.RYBREVANT® with LAZCLUZE®In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2.RYBREVANT® as a Single AgentIn CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2.Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT® and continue LAZCLUZE® based on severity.Embryo-Fetal ToxicityBased on animal models, RYBREVANT FASPRO™, RYBREVANT® and LAZCLUZE® can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO™ and RYBREVANT®. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO™ or RYBREVANT®, and for 3 weeks after the last dose of LAZCLUZE®.ADVERSE REACTIONSRYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3 (n=206), the most common adverse reactions (≥20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gammaglutamyl transferase (2%), and decreased hemoglobin (2%).Serious adverse reactions occurred in 33% of patients, with those occurring in ≥2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO™, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).RYBREVANT® with LAZCLUZE®In MARIPOSA (n=421), the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT®) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT®) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).RYBREVANT® with Carboplatin and PemetrexedIn MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.RYBREVANT® as a Single AgentIn CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.LAZCLUZE® DRUG INTERACTIONSAvoid concomitant use of LAZCLUZE® with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.Please see full Prescribing Information for RYBREVANT FASPRO™, RYBREVANT® and LAZCLUZE®.cp-491009v2About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of RYBREVANT®-based regimens. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com, or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.###* Joel W. Neal, M.D., Ph.D., has served as a consultant to Johnson & Johnson; he has not been paid for any media work.† Once monthly after weekly injections from weeks 1-4.‡ The NCCN content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.§ See the NCCN Guidelines for detailed recommendations, including other treatment options.|| The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.Source: Johnson & Johnson1 Neal JW, et al. Overall survival of first-line amivantamab plus lazertinib in atypical EGFR-mutated advanced NSCLC: Updated results from the CHRYSALIS-2 study. Presented at: 2026 ASCO Annual Meeting; 2026; Chicago, IL.
2 Tomasini P, Wang Y, Li Y, et al. Amivantamab Plus Lazertinib in Atypical EGFR-Mutated Advanced Non-Small Cell Lung Cancer: Results From CHRYSALIS-2. J Clin Oncol. 2026;44(1):54-65. doi:10.1200/JCO-24-02835
3 Kim EY, Cho EN, Park HS, et al. Compound EGFR mutation is frequently detected with co-mutations of actionable genes and associated with poor clinical outcome in lung adenocarcinoma. Cancer Biol Ther. 2016;17(3):237-245.  doi:10.1080/15384047.2016.1139235
4 Patil T, Mushtaq R, Marsh S, et al. Clinicopathologic characteristics, treatment outcomes, and acquired resistance patterns of atypical EGFR mutations and HER2 alterations in stage IV non-small-cell lung cancer. Clin Lung Cancer. 2020;21(3):e191-e204. doi:10.1016/j.cllc.2019.11.008
5 Fabrizio FP, Attili I, de Marinis F. Uncommon and Rare EGFR Mutations in Non-Small Cell Lung Cancer Patients with a Focus on Exon 20 Insertions and the Phase 3 PAPILLON Trial: The State of the Art. Cancers. 2024; 16(7):1331.  https://doi.org/10.3390/cancers16071331
6 Yang JC, Sequist LV, Geater SL, et al. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015;16(7):830-838. doi:10.1016/S1470-2045(15)00026-1
7 GILOTRIF® (afatinib tablets), for oral use [package insert]. Boehringer Ingelheim Pharmaceuticals, Inc.; 2022.
8 Moores SL, Chiu ML, Bushey BS, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res. 2016;76(13):3942-3953. doi:10.1158/0008-5472.CAN-15-2833
9 Vijayaraghavan S, Lipfert L, Chevalier K, et al. Amivantamab (JNJ-61186372), an Fc Enhanced EGFR/cMet Bispecific Antibody, Induces Receptor Downmodulation and Antitumor Activity by Monocyte/Macrophage Trogocytosis. Mol Cancer Ther. 2020;19(10):2044-2056. doi:10.1158/1535-7163.MCT-20-0071 
10 Yun J, Lee SH, Kim SY, et al. Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR-MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion-Driven NSCLC. Cancer Discov. 2020;10(8):1194-1209. doi:10.1158/2159-8290.CD-20-0116
11 Asia-Pacific practical consensus in the management of adverse events related to amivantamab-based therapies in non-small cell lung cancer. Lung Cancer. Published online May 22, 2026. doi:10.1016/S0169-5002(26)00466-6.
12 RYBREVANT® Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
13 ClinicalTrials.gov. A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer (CHRYSALIS-2). Available at: https://clinicaltrials.gov/ct2/show/NCT04077463. Accessed May 2026.
14 The World Health Organization. Cancer. https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed May 2026.
15 American Cancer Society. What is Lung Cancer? https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html. Accessed May 2026.
16 Oxnard JR, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013 Feb;8(2):179-84. doi: 10.1097/JTO.0b013e3182779d18.
17 Bauml JM, et al. Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-based Real World Datasets. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
18 Pennell NA, et al. A phase II trial of adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small cell lung cancer. J Clin Oncol. 37:97-104.
19 Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
20 Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-78993.
21 Midha A, et al. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity. Am J Cancer Res. 2015;5(9):2892-2911.
22 American Lung Association. EGFR and Lung Cancer. https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/egfr. Accessed May 2026.
23 Howlader N, et al. SEER Cancer Statistics Review, 1975-2016, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the SEER web site.
24 Lin JJ, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65.
25 Arcila, M. et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013 Feb; 12(2):220-9.
26 Girard N, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
27 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2026 © National Comprehensive Cancer Network, Inc. All rights reserved. To view the most recent and complete version of the guideline, go online to NCCN.org. Accessed May 2026.
28 Cho BC, et al. Lazertinib versus gefitinib as first-line treatment in patients with EGFR-mutated advanced non-small-cell lung cancer: Results From LASER301. J Clin Oncol. 2023;41(26):4208-4217.
29 LAZCLUZE® Prescribing Information. Horsham, PA: Janssen Biotech, Inc.Media contact:
Oncology Media Relations
oncology_media_relations@its.jnj.comInvestor contact:
Jess Margevich
investor-relations@its.jnj.com


U.S. Medical Inquiries:+1 800 526-7736   View original content to download multimedia:https://www.prnewswire.com/news-releases/rybrevant-amivantamab-vmjw-plus-lazcluze-lazertinib-demonstrates-prolonged-clinical-benefit-as-a-first-line-treatment-for-atypical-egfr-mutated-non-small-cell-lung-cancer-302785924.htmlSOURCE Johnson & Johnson Original: RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) demonstrates prolonged clinical benefit as a first-line treatment for atypical EGFR-mutated non-small cell lung cancer

New TECVAYLI® (teclistamab-cqyv) data demonstrate superior progression-free and overall survival as early as first relapse in multiple myelomaMay 29, 2026 8:18 AM
PR Newswire (US) Building on the recent approval of Johnson & Johnson's TECVAYLI® plus DARZALEX FASPRO®, MajesTEC-9 is the second positive Phase 3 study to reinforce the strength of TECVAYLI® as early as second line TECVAYLI® delivered deep and durable responses with nearly two-thirds of patients achieving a complete response or betterCHICAGO, May 29, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ), a worldwide leader in multiple myeloma therapies, today announced new data from the Phase 3 MajesTEC-9 study demonstrating clinically meaningful and statistically significant improvements in progression-free survival (PFS) and overall survival (OS) with TECVAYLI® (teclistamab-cqyv) versus standard of care regimens in patients with relapsed or refractory multiple myeloma treated as early as second line. In a patient population whose myeloma was predominantly refractory to anti-CD38 therapy and lenalidomide, TECVAYLI® reduced the risk of disease progression or death by 71% and the risk of death by 40%.1 These data (Abstract #7507) will be presented as an oral session today at the annual American Society of Clinical Oncology (ASCO) Annual Meeting, with simultaneous publication in The New England Journal of Medicine. Expert and company perspectives support the strength of TECVAYLI® "These findings further reinforce TECVAYLI's potential to meaningfully improve survival outcomes for patients with multiple myeloma in earlier lines," said Roberto Mina, M.D., Associate Professor, Winship Cancer Institute of Emory University.* "These results will continue to transform the role of bispecifics in clinical decision-making as early as first relapse—offering a steroid-sparing, community-based therapy for patients across all practice settings, regardless of prior anti-CD38 exposure.""After the recent approval of TECVAYLI plus DARZALEX FASPRO, a potential new standard of care, these results add to the growing body of evidence reinforcing the clinical power of TECVAYLI earlier in the treatment paradigm," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "These findings further demonstrate how we're leading in multiple myeloma as we bring new options to better match the right therapy to the right patient at each stage of disease."MajesTEC-9 study results The MajesTEC-9 study evaluated TECVAYLI®, a bispecific T-cell engager antibody therapy, versus the standard of care of pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including lenalidomide and a CD38 monoclonal antibody.1 Efficacy benefits were observed in a heavily pre-treated population, including patients predominantly refractory to anti-CD38 monoclonal antibodies (85%) and lenalidomide (79%), and more than 90% of patients who were refractory to their last line of therapy.1 Treatment with TECVAYLI® demonstrated a 71% reduction in the risk of disease progression or death (hazard ratio [HR]=0.29; 95% confidence interval [CI], 0.23, 0.38) and a 40% reduction in the risk of death (HR=0.60; 95% CI, 0.43, 0.83)] compared to standard of care, demonstrating significant improvements in both PFS and OS.1 Additionally, all key secondary endpoints showed significant improvement with TECVAYLI® versus standard of care, including nearly two-thirds of patients achieving a complete response or better (≥CR; 65.9% vs. 16.8%).1The overall safety profile for TECVAYLI® in the study was consistent with its known safety profile. TECVAYLI® had similar rates of treatment-emergent adverse events (TEAEs) compared to standard of care (99.7% vs. 97.9%).1 Grade 3/4 TEAEs were reported by 84.9% of patients treated with TECVAYLI®, compared with 76.3% of patients receiving standard of care.1 Grade 5 TEAEs were uncommon across the two treatment groups (6.5% vs. 3.5%).1 The majority of Grade 5 TEAEs in both groups were due to infections (5.5% vs. 2.8%) and most occurred within the first six months of treatment initiation.1 Infections were more frequent with TECVAYLI® compared to standard of care (Grade 3/4, 41.6% vs. 29.0%); However, rates of Grade 3 or higher infections declined over time with disease control.1 Cytokine release syndrome occurred in 66.0% of patients treated with TECVAYLI®, mostly Grade 1 and managed with standard mitigation strategies.1 All events resolved and none led to treatment discontinuation.1 Immune effector cell-associated neurotoxicity syndrome was infrequent, occurring in 4.1% of patients and primarily Grade 1/2.1 Median duration of treatment on TECVAYLI® was almost two times longer than standard of care (13.1 vs 7.0 months).1Regulatory review and next steps Based on these results, Johnson & Johnson is working with regulatory bodies globally to consider TECVAYLI® as early as second line. Applications for regulatory approval have been submitted to the U.S. Food and Drug Administration and the European Medicines Agency (EMA).About the MajesTEC–9 Study
MajesTEC-9 (NCT05572515) is an ongoing, randomized Phase 3 study comparing teclistamab monotherapy with pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with RRMM who have received 1–3 prior lines including lenalidomide and CD38 monoclonal antibody. The primary endpoint is PFS; secondary endpoints include complete response or better (≥CR), duration of response (DoR), time to next treatment (TTNT), progression-free survival on next line of therapy (PFS2), overall survival (OS), safety, and patient-reported outcomes.About Multiple Myeloma
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.2 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.3 Multiple myeloma is the third most common blood cancer worldwide.4 More than 180,000 new cases of multiple myeloma are diagnosed globally each year.5 People living with multiple myeloma have a 5-year survival rate of 59.8 percent.6 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.7,8 In recent years, overall survival has improved from years to decades, with effective treatment options now available across every stage and line of therapy.9About TECVAYLI®TECVAYLI® (teclistamab-cqyv) is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. TECVAYLI® received accelerated approval from the U.S. Food and Drug Administration (FDA) in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.10In February 2024, the U.S. FDA approved the supplemental Biologics License Application (sBLA) for TECVAYLI® for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients with RRMM who achieved and maintained a complete response (CR) or better for a minimum of six months.In March 2026, the U.S. FDA approved TECVAYLI® in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. The supplemental Biologics License Application was proactively selected for the Commissioner's National Priority Voucher Pilot Program and also granted the application Breakthrough Therapy Designation and Real-Time Oncology Review. This approval expanded the use of TECVAYLI® into earlier lines of therapy and is the first bispecific antibody-based combination regimen in this setting.To date, more than 26,000 patients have been treated worldwide with TECVAYLI®.The European Commission (EC) granted TECVAYLI® conditional marketing authorization in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy. In August 2023, the EC approved a Type II variation application for TECVAYLI®, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients who have achieved a complete response or better for a minimum of six months.For more information, visit www.TECVAYLI.com.About DARZALEX FASPRO® and DARZALEX®DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for 11 indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.11 It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.DARZALEX® (daratumumab) received U.S. FDA approval in November 2015 and is approved in eight indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant eligible and ineligible.12 In 2025, DARZALEX FASPRO® was approved by the U.S. FDA and EMA as the first and only treatment for patients with high-risk smoldering multiple myeloma.DARZALEX® is the first CD38-directed antibody approved to treat multiple myeloma.5 DARZALEX®-based regimens have been used in the treatment of more than 748,000 patients worldwide and more than 68,000 patients in the U.S. alone.In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab.For more information, visit www.DARZALEX.com.TECVAYLI® INDICATIONS AND IMPORTANT SAFETY INFORMATIONINDICATIONS AND USAGETECVAYLI® (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma:in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.IMPORTANT SAFETY INFORMATIONWARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROMECytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity.Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening, or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity.TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY® Risk Evaluation and Mitigation Strategy (REMS).WARNINGS AND PRECAUTIONSCytokine Release Syndrome - TECVAYLI can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions.In the clinical trials (monotherapy and combination therapy; N=448), CRS occurred in 64% of patients who received TECVAYLI at the recommended dose, with Grade 1 CRS occurring in 46% of patients, Grade 2 in 18%, and Grade 3 in 0.2%. Recurrent CRS occurred in 27% of patients. Most patients experienced CRS during the initial step-up dosing schedule (step-up dose 1 [37%], step-up dose 2 [32%], or the initial treatment dose [20%]). CRS first occurred following subsequent doses of TECVAYLI in 2.5% of patients. The median time to onset of CRS was 2 (range: 1 to 9) days after the most recent dose and the median duration of CRS was 2 (range: 1 to 22) days.Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation).Initiate therapy according to TECVAYLI step-up dosing schedule to reduce risk of CRS. Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI accordingly.At the first sign of CRS, immediately evaluate patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold until CRS resolves or permanently discontinue TECVAYLI based on severity.TECVAYLI is available only through a restricted program under a REMS.Neurologic Toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome - TECVAYLI can cause serious, life-threatening, or fatal neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).In the clinical trials (monotherapy and combination therapy trials; N=448), neurologic toxicity occurred in 60% of patients who received TECVAYLI at the recommended dosage, with Grade 3 or 4 neurologic toxicity in 6%. Neurologic toxicities reported in ≥5% of patients included headache (27%), sensory neuropathy (16%), motor dysfunction (15%), insomnia (12%), encephalopathy (11%), and dizziness (8%). Fatal neurologic toxicity occurred in 0.4% of patients, including Guillain-Barré syndrome and status epilepticus (one patient each).In MajesTEC-1, ICANS was reported in 6% of patients who received TECVAYLI as monotherapy at the recommended dosage. Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent TECVAYLI doses. The median time to onset of ICANS was 4 (range: 2 to 8) days after the most recent dose with a median duration of 3 (range: 1 to 20) days. The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia.In MajesTEC-3, ICANS was reported in 1.1% of patients who received the recommended TECVAYLI dosage in combination with daratumumab and hyaluronidase-fihj, including Grade 4 ICANS in 1 patient. All events of ICANS occurred during the step-up dosing schedule. The median time to onset of ICANS was 2 (range: 1 to 3) days after the most recent dose and the median duration of ICANS was 2 (range: 1 to 2) days. The clinical manifestations of ICANS reported were amnesia, encephalopathy and delirium.The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.Monitor patients for signs and symptoms of neurologic toxicity, including ICANS during TECVAYLI treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold until neurologic toxicity resolves or permanently discontinue TECVAYLI based on severity per recommendations and consider further management per current practice guidelines.Due to the potential for neurologic toxicity, patients receiving TECVAYLI are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves.TECVAYLI is available only through a restricted program under a REMS.TECVAYLI and TALVEY REMS - TECVAYLI is available only through a restricted program under a REMS called the TECVAYLI and TALVEY REMS because of the risks of CRS and neurologic toxicity, including ICANS.Hepatotoxicity - TECVAYLI can cause hepatotoxicity, including fatalities. There was one fatal case of hepatic failure in MajesTEC-1. In patients who received TECVAYLI at the recommended dose in the clinical trials (monotherapy and combination therapy trials; N=448) elevated aspartate aminotransferase (AST) occurred in 47% of patients, with Grade 3 or 4 elevations in 2.9%. Elevated alanine aminotransferase (ALT) occurred in 48% of patients, with Grade 3 or 4 elevations in 3.8%. Elevated total bilirubin occurred in 10% of patients with Grade 3 or 4 elevations in 0.7%. Liver enzyme elevation can occur with or without concurrent CRS.Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity.Infections - TECVAYLI can cause severe, life-threatening, or fatal infections.In MajesTEC-1 (N=165), in patients who received the recommended TECVAYLI dosage, serious infections, including opportunistic infections, occurred in 30% of patients, Grade 3 or 4 infections in 35% of patients, and fatal infections in 4.2% of patients.In MajesTEC-3 (N=283), in patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj at the recommended dosage, serious infections, including opportunistic infections, occurred in 54% of patients, Grade 3 or Grade 4 infections in 54% of patients, and fatal infections in 4.6% of patients.Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI and treat appropriately. Administer prophylactic antimicrobials according to current practice guidelines.Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity.Monitor immunoglobulin levels prior to and during treatment with TECVAYLI and administer subcutaneous or intravenous immunoglobulin (IVIG) to maintain the serum levels >400 mg/dL.Neutropenia - TECVAYLI can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI at the recommended dose in the clinical trials (monotherapy and combination therapy trials; N=448), decreased neutrophils occurred in 88% of patients, with Grade 3 or 4 decreased neutrophils in 70%. Febrile neutropenia occurred in 6% of patients.Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines.Monitor patients with neutropenia for signs of infection.Withhold TECVAYLI based on severity.Hypersensitivity and Other Administration Reactions - TECVAYLI can cause both systemic administration-related and local injection-site reactions.Systemic Reactions - In patients who received the recommended TECVAYLI dosage in the clinical trials (monotherapy and combination therapy trials; N=448), 2.5% of patients experienced systemic-administration reactions, which included recurrent pyrexia and rash.Local Reactions - In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), injection-site reactions occurred in 37% of patients, with Grade 1 injection-site reactions in 29% and Grade 2 in 9%.Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity.Embryo-Fetal Toxicity - Based on its mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant patient. Advise pregnant patients of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI and for 5 months after the last dose.ADVERSE REACTIONS
The most common adverse reactions (≥20%) in patients who received TECVAYLI monotherapy were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common adverse reactions (≥20%) in patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj were hypogammaglobulinemia, upper respiratory tract infection, CRS, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection site reaction, fatigue, pyrexia, headache, nausea, gastroenteritis, and weight decreased.The most common Grade 3 to 4 laboratory abnormalities (≥20%) with TECVAYLI (as monotherapy or in combination with daratumumab and hyaluronidase-fihj) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.Please read full Prescribing Information, including Boxed WARNING, for TECVAYLI.DARZALEX FASPRO® INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONSDARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma:In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplantIn combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplantIn combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapyIn combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplantIn combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (PI)In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapyIn combination with bortezomib and dexamethasone in patients who have received at least one prior therapyAs monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agentDARZALEX FASPRO® as monotherapy is indicated for the treatment of adult patients with high-risk smoldering multiple myeloma.IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS  DARZALEX FASPRO® is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation.  WARNINGS AND PRECAUTIONS  Hypersensitivity and Other Administration Reactions  Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO®. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO®. Systemic Reactions  In a pooled safety population of 1446 patients with multiple myeloma (N=1235) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO® as monotherapy or in combination, 7% of patients experienced a systemic administration-related reaction (Grade 2: 3%, Grade 3: 0.8%, Grade 4: 0.1%). In patients with high-risk smoldering multiple myeloma (N=193), systemic administration-related reactions occurred in 17% of patients in AQUILA (Grade 2: 7%, Grade 3: 1%).In all patients (N=1639), systemic administration-related reactions occurred in 7% of patients with the first injection, 0.5% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 3.2 hours (range: 4 minutes to 3.5 days). Of the 283 systemic administration-related reactions that occurred in 135 patients, 240 (85%) occurred on the day of DARZALEX FASPRO® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients.Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision.Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO®. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions.  Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO®.  Local ReactionsIn this pooled safety population of 1446 patients with multiple myeloma (N=1253) or light chain amyloidosis (N=193), injection-site reactions occurred in 8% of patients, including Grade 2 reactions in 1.1%. The most frequent (>1%) injection-site reaction were injection site erythema and injection site rash. In patients with high-risk smoldering multiple myeloma (N=193), injection-site reactions occurred in 28% of patients, including Grade 2 reactions in 3%. These local reactions occurred a median of 6 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO®. Monitor for local reactions and consider symptomatic management.InfectionsDARZALEX FASPRO® can cause serious, life-threatening, or fatal infections. In patients who received DARZALEX FASPRO® in a pooled safety population including patients with smoldering multiple myeloma and light chain (AL) amyloidosis (N=1639), serious infections, including opportunistic infections, occurred in 24% of patients, Grade 3 or 4 infections occurred in 22%, and fatal infections occurred in 2.5%. The most common type of serious infection reported was pneumonia (8.5%).Monitor patients for signs and symptoms of infection prior to and during treatment with DARZALEX FASPRO® and treat appropriately. Administer prophylactic antimicrobials according to guidelines.Neutropenia  Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO® until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO®, higher rates of Grade 3-4 neutropenia were observed.  Thrombocytopenia  Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX FASPRO® until recovery of platelets.  Embryo-Fetal Toxicity  Based on the mechanism of action, DARZALEX FASPRO® can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO® and for 3 months after the last dose.  The combination of DARZALEX FASPRO® with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy.  Interference With Serological Testing  Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted.  Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO®. Type and screen patients prior to starting DARZALEX FASPRO®.  Interference With Determination of Complete Response  Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO®-treated patients with IgG kappa myeloma protein.  ADVERSE REACTIONS  In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, rash, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, musculoskeletal pain, upper respiratory tract infection, , peripheral neuropathy, peripheral sensory neuropathy, constipation, pneumonia, edema, peripheral edema, and anemia.The most common adverse reactions (≥20%) in patients with high-risk smoldering multiple myeloma who received DARZALEX FASPRO® monotherapy are upper respiratory tract infection, musculoskeletal pain, fatigue, diarrhea, rash, sleep disorder, sensory neuropathy, and injection site reactions.The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.  Please click here to read the full Prescribing Information for DARZALEX FASPRO®.  DARZALEX® INDICATIONS AND IMPORTANT SAFETY INFORMATIONINDICATIONSDARZALEX® (daratumumab) is indicated for the treatment of adult patients with multiple myeloma:In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplantIn combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapyIn combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplantIn combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitorIn combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapyIn combination with bortezomib and dexamethasone in patients who have received at least one prior therapyAs monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agentCONTRAINDICATIONSDARZALEX® is contraindicated in patients with a history of severe hypersensitivity (eg, anaphylactic reactions) to daratumumab or any of the components of the formulation.WARNINGS AND PRECAUTIONSInfusion-Related ReactionsDARZALEX® can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life threatening, and fatal outcomes have been reported. In clinical trials (monotherapy and combination: N=2066), infusion-related reactions occurred in 37% of patients with the Week 1 (16 mg/kg) infusion, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions. Less than 1% of patients had a Grade 3/4 infusion-related reaction at Week 2 or subsequent infusions. The median time to onset was 1.5 hours (range: 0 to 73 hours). Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX®. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension and blurred vision.When DARZALEX® dosing was interrupted in the setting of ASCT (CASSIOPEIA) for a median of 3.75 months (range: 2.4 to 6.9 months), upon re-initiation of DARZALEX®, the incidence of infusion-related reactions was 11% for the first infusion following ASCT. Infusion-related reactions occurring at re-initiation of DARZALEX® following ASCT were consistent in terms of symptoms and severity (Grade 3 or 4:

FDA approves label expansion, cementing TREMFYA® as the only IL-23 inhibitor proven to help stop further joint damageMay 28, 2026 7:10 PM
PR Newswire (US) TREMFYA® showed significant inhibition of structural joint damage in adults with active psoriatic arthritisHORSHAM, Pa., May 28, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to include evidence in the TREMFYA® (guselkumab) label for the inhibition of progression of structural joint damage in adults with active psoriatic arthritis (PsA). The inclusion of this key outcome reflects that TREMFYA is the only IL-23 inhibitor proven to help stop further structural damage, offering patients with active PsA a first-line treatment option that provides effective symptom control and no new safety signals, while significantly inhibiting irreversible joint damage. "Joint damage associated with active psoriatic arthritis can happen as soon as six months after onset of disease, so it's important to have treatment solutions that can help provide daily symptom relief while also protecting joints from long-term structural damage," said Philip J. Mease,a M.D., Director of Rheumatology Research at the Swedish Medical Center/Providence St. Joseph Health and Clinical Professor at the University of Washington School of Medicine in Seattle, WA. "With the inclusion of these findings in the label, we now have stronger clinical evidence that sets TREMFYA apart as a treatment option for patients with active psoriatic arthritis at risk for joint damage."The label update is supported by 24-week results from the Phase 3b APEX study. The study met its primary endpoint of reducing joint symptoms (ACR20) and its major secondary endpoint of inhibiting progression of structural damage, as measured by change in the PsA-modified van der Heijde-Sharp (vdH-S) scoreb, compared to placebo in bio-naïve patients.1,2,3Additionally, for patients in the study's placebo group who switched to TREMFYA at Week 24, the rate of radiographic progression was reduced by 57% from Week 24 through Week 48, demonstrating benefit even after initial disease progression. Data from the APEX study were consistent with the well-established safety profile of TREMFYA, with no new safety signals identified.4"Up to half of all patients living with active psoriatic arthritis can develop early irreversible joint damage, leaving them unable to perform simple daily tasks or go to work," said Brandee Pappalardo, Ph.D., M.P.H., Vice President, Medical Affairs, Dermatology & Rheumatology, Johnson & Johnson Innovative Medicine. "This label update reinforces our commitment to advancing innovation for these patients by offering the only IL-23 inhibitor with structural inhibition in its label, making TREMFYA a differentiated treatment option for symptom relief and joint preservation that helps address the progressive nature of active psoriatic arthritis."TREMFYA is the only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocytes, macrophages, and dendritic cells that is known to be a driver of immune-mediated diseases including active PsA, moderate to severe plaque psoriasis (PsO), moderate to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD). Findings are based on in vitro.5,6,7,8,9Editor's notes: 
a. Dr. Philip Mease is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.
b. VdH-S scores are from the Week 48 x-ray read.ABOUT APEX (NCT04882098)
APEX is a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies (e.g., csDMARDs, apremilast, and/or NSAIDs). The treatment duration includes a 24-week, double-blind, placebo-controlled period, followed by a 24-week active treatment period, followed by a 12-week safety follow-up period. For patients who agree to enter the long-term extension, an additional 2 years of active treatment is scheduled prior to the final safety follow-up.10ABOUT PSORIATIC ARTHRITIS
Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO).11,12,13 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.14 Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale.15 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.16 Studies show up to 30% of people with plaque PsO also develop PsA.10ABOUT TREMFYA (guselkumab)
Developed by Johnson & Johnson, TREMFYA is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.TREMFYA is a prescription medicine approved in the U.S. to treat:adults and children 6 years of age and older who also weigh at least 88 pounds (40 kg) with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with active psoriatic arthritis.adults with moderately to severely active ulcerative colitis.adults with moderately to severely active Crohn's disease.TREMFYA is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate to severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis.The legal manufacturer for TREMFYA is Janssen Biotech, Inc.Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA. For more information, visit: www.tremfya.com.TREMFYA® IMPORTANT SAFETY INFORMATIONWhat is the most important information I should know about TREMFYA®? TREMFYA® is a prescription medicine that may cause serious side effects, including:Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling lightheaded (low blood pressure)swelling of your face, eyelids, lips, mouth, tongue or throat  trouble breathing or throat tightnesschest tightnessskin rash, hivesitching Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®.          Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chillsmuscle achesweight losscoughwarm, red, or painful skin or sores on your body different from your psoriasis  diarrhea or stomach painshortness of breathblood in your phlegm (mucus)burning when you urinate or urinating more often than normal Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. With the treatment of plaque psoriasis or psoriatic arthritis, your healthcare provider may do blood tests to check your liver before and as necessary during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rashvomitingtiredness (fatigue)yellowing of the skin or the whites of your eyes  nauseastomach pain (abdominal)loss of appetitedark urine Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®.Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you:have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA®?"have an infection that does not go away or that keeps coming back.have TB or have been in close contact with someone with TB.have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. Children should be brought up to date with all vaccines before starting TREMFYA®are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby.Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy.are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk.          Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.What are the possible side effects of TREMFYA®?TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?"The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, bronchitis, feeling very tired (fatigue), fever (pyrexia), and skin rash.These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects.Use TREMFYA® exactly as your healthcare provider tells you to use it.Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor.You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion.ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/ or at https://www.jnj.com/innovativemedicine/.Follow us at @JNJInnovMed.© Johnson & Johnson and its affiliates 2026. All rights reserved.CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.1 Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: Results through Week 24 of the phase 3b, randomized, double-blind, placebo-controlled APEX study. Abstract presented at: European Alliance of Associations for Rheumatology (EULAR) 2025 Congress; June 11-14, 2025; Barcelona, Spain. Late-Breaking Abstracts Session II.
2 Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: Results through Week 24 of the phase 3b, randomized, double-blind, placebo-controlled APEX study. Oral presentation at: European Alliance of Associations for Rheumatology (EULAR) 2025 Congress; June 11-14, 2025; Barcelona, Spain.
3 Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with the selective interleukin-23 inhibitor guselkumab in participants with active PsA: results through week 24 of the phase 3b, randomised, double-blind, placebo-controlled APEX study. Ann Rheum Dis. 2025;84(12):1983-1994. 
4 Ritchlin CT, et al. Durable Inhibition of Structural Damage Progression and Improvements in Joint Disease Activity With the Selective Interleukin-23 Inhibitor Guselkumab in Active and Erosive Psoriatic Arthritis: Week 48 Results From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study. Presented at ISDS 2025. November 12-15. Poster 331.
5 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504.
6 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217.
7 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
8 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc.
9 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company.
10 ClinicalTrials.gov. A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX). Identifier: NCT04882098. Available at: https://clinicaltrials.gov/study/NCT04882098. Accessed May 2026.
11 Donvito T., CreakyJoints: What Is Dactylitis? The 'Sausage Finger' Swelling You Should Know About. Available at: https://creakyjoints.org/symptoms/what-is-dactylitis/. Accessed May 2026.
12 Belasco J., Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther. 2019 Sep;6(3):305-315. Available at: https://pubmed.ncbi.nlm.nih.gov/31102105/. Accessed May 2026.
13 Gower, T. Enthesitis and PsA. Arthritis Foundation. Available at: https://www.arthritis.org/health-wellness/about-arthritis/related-conditions/physical-effects/enthesitis-and-psa. Accessed May 2026.
14 National Psoriasis Foundation. About Psoriatic Arthritis. Available at: https://www.psoriasis.org/about-psoriatic-arthritis/. Accessed May 2026.
15 Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: https://doi.org/10.1136/ard.2008.098202. Accessed May 2026.
16 Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: https://doi.org/10.5041/RMMJ.10279. Accessed May 2026.Media contact: 
Camilia Aberra caberra@its.jnj.com  

Investor contact: Jess Margevichinvestor-relations@its.jnj.com   
  View original content to download multimedia:https://www.prnewswire.com/news-releases/fda-approves-label-expansion-cementing-tremfya-as-the-only-il23-inhibitor-proven-to-help-stop-further-joint-damage-302785103.htmlSOURCE Johnson & Johnson Original: FDA approves label expansion, cementing TREMFYA® as the only IL-23 inhibitor proven to help stop further joint damage

Johnson & Johnson to Host Investor Conference Call on Second-Quarter ResultsMay 27, 2026 4:22 PM
Business Wire Johnson & Johnson (NYSE: JNJ) will host a conference call for investors at 8:30 a.m. (Eastern Time) on Wednesday, July 15th to review second-quarter results. Joaquin Duato, Chairman and Chief Executive Officer, Joseph J. Wolk, Executive Vice President and Chief Financial Officer and Ryan Koors, Vice President, Investor Relations will host the call. The question and answer portion of the call will also include additional members of Johnson & Johnson’s executive team. Investors and other interested parties can access the webcast/conference call in the following ways: The webcast and presentation material are accessible at Johnson & Johnson’s website www.investor.jnj.com. A replay of the webcast will be available approximately three hours after the conference call concludes. By telephone: for both “listen-only” participants and those financial analysts who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is 877-869-3847. For participants outside the U.S., the dial-in number is 201-689-8261. A replay of the conference call will be available until approximately 12:00 a.m. on July 29th. The replay dial-in number for U.S. participants is 877-660-6853. For participants outside the U.S., the replay dial-in number is 201-612-7415. The replay conference ID number for all callers is 13760885. The press release will be available at approximately 6:45 a.m. (Eastern Time) the morning of the conference call. Please refer to www.investor.jnj.com for a complete list of currently planned earnings webcast/conference calls. Please note the third-quarter date of Tuesday, October 13th, 2026. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. View source version on businesswire.com: https://www.businesswire.com/news/home/20260527068310/en/ Media contact:
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investor-relations@its.jnj.com Original: Johnson & Johnson to Host Investor Conference Call on Second-Quarter Results

DePuy Synthes secures exclusive NOVOSIS bone graft distribution partnership (JNJ)May 26, 2026 9:12 AM
IH Market News DePuy Synthes, a subsidiary of Johnson & Johnson (NYSE:JNJ), announced an exclusive distribution agreement with CGBIO for the bone graft substitute NOVOSIS across the United States, Canada and Australia. NOVOSIS designed for multiple orthopaedic applications NOVOSIS is a growth factor-based bone graft substitute intended for use in a range of orthopaedic procedures, including spinal surgery, craniomaxillofacial procedures and trauma-related applications. The product is currently being evaluated in the United States through an investigational device exemption study focused on spinal procedures to assess both safety and clinical effectiveness. Agreement expands existing partnership between companies Under the terms of the deal, DePuy Synthes receives exclusive distribution rights for NOVOSIS in the three designated markets, along with rights of first negotiation for potential expansion into additional global territories. The latest agreement builds on an earlier partnership signed in February 2025, which granted Johnson & Johnson and DePuy Synthes distribution rights for the product in Korea, Taiwan, Thailand, India, Hong Kong and Macau. DePuy Synthes strengthens regenerative medicine portfolio “This collaboration reflects our continued focus on strengthening our portfolio with differentiated technologies that address unmet needs and support patient care,” said Namal Nawana, Worldwide President of DePuy Synthes. CGBIO specializes in regenerative medicine technologies, and the addition of NOVOSIS further expands DePuy Synthes’ orthopaedics portfolio, which already includes products for joint reconstruction, trauma care, spinal surgery and sports medicine. Commercial launch remains subject to approvals The companies said future commercialization of NOVOSIS will depend on the outcome of clinical studies and receipt of the necessary regulatory approvals. The announcement was disclosed through a company press release. Johnson & Johnson stock price Original: DePuy Synthes secures exclusive NOVOSIS bone graft distribution partnership (JNJ)

CNS Drug Delivery Technologies Are Reshaping Alzheimer's and Biodefense ResearchMay 13, 2026 9:00 AM
InvestorsHub NewsWireCNS Drug Delivery Technologies Are Reshaping Alzheimer's and Biodefense ResearchBioMedWire Editorial Coverage: Among the most guarded structures in human biology, the brain is also one of the hardest to treat. The blood-brain barrier ("BBB"), a specialized biological membrane, shields neural tissue from foreign substances, including most therapeutic agents. As cases of Alzheimer's disease climb worldwide and governments sharpen their focus on biodefense, the absence of efficient pathways for delivering drugs to the brain is fast becoming one of medicine's most pressing unresolved problems. Companies such as Oncotelic Therapeutics Inc. (OTCQB: OTLC) (Profile) are responding to this challenge with next-generation delivery platforms engineered to circumvent biological barriers and ensure direct, targeted access to the central nervous system ("CNS"). Oncotelic has developed a proprietary intranasal nose-to-brain ("N2B") system capable of rapidly shuttling therapeutics to the brain, a signal of growing industry consensus that delivery innovation, not merely drug discovery, will drive the next wave of breakthroughs in CNS medicine. Oncotelic joins a group of leading biopharma companies working in the biopharmaceutical and advanced therapeutics space, including Amgen Inc. (NASDAQ: AMGN), Johnson & Johnson (NYSE: JNJ), AbbVie Inc. (NYSE: ABBV) and Lunai Bioworks Inc. (NASDAQ: LNAI).While the blood-brain barrier is vital for maintaining neurological health, it simultaneously creates a major obstacle for drug developers.Oncotelic Therapeutics is pursuing a position in a segment of the market focused on enabling faster, more reliable access to the brain.CNS drug delivery is not only a concern for chronic disease, it is also a strategic priority in the area of national security and biodefense.Designed as a device-enabled approach to direct CNS delivery, Oncotelic's N2B delivery system offers a potential alternative to traditional systemic or intramuscular routes.Oncotelic Therapeutics is building along these lines. Its focus on scalable, adaptable delivery infrastructure positions the company to pursue multiple CNS indications from a shared platform base.Click here to view the custom infographic of the Oncotelic Therapeutics editorial.Why the Blood-Brain Barrier Is So Difficult to OvercomeThe blood-brain barrier functions as a tightly regulated biological filter, shielding brain tissue from harmful substances traveling through the bloodstream. While this defense mechanism is vital for maintaining neurological health, it simultaneously creates a major obstacle for drug developers. Research shows that the BBB blocks the passage of most chemical compounds, permitting entry only to certain molecules that meet narrow size and chemistry criteria. The result is that even promising therapeutic candidates often fail to produce meaningful effects simply because they cannot reach the brain in sufficient concentrations.The scale of this problem is striking. Scientific consensus suggests that close to 98% of small-molecule drugs and virtually all biologic therapies are unable to cross the BBB effectively, making this a defining limitation in CNS pharmaceutical development. It also contributes disproportionately to clinical trial failures in neurology, compounds that show real therapeutic promise may nonetheless stumble in trials not because the drug is ineffective, but because it cannot reach its target.The downstream consequences reach across some of the most prevalent and devastating conditions in neurology, from Alzheimer's and Parkinson's disease to primary brain tumors. After decades of intensive research and massive capital investment, effective treatment options for many CNS disorders remain frustratingly scarce. The persistent failure to achieve adequate drug concentrations in the brain has slowed progress across the field, making the search for workable delivery solutions an urgent scientific and commercial priority.Within this context, Oncotelic Therapeutics is developing technologies specifically aimed at getting around these BBB limitations. A concrete marker of progress is the company's recent announcement that it has finalized a strategic monetization agreement with Lunai Bioworks, in which Oncotelic transferred rights to its N2B delivery system for defined applications in biodefense and Alzheimer's disease."Under the terms of the agreement, Oncotelic has granted Lunai Bioworks worldwide rights to the N2B delivery system IP portfolio within defined fields, specifically biodefense medical countermeasures and Alzheimer's disease only," the announcement stated. "The company continues to evaluate additional partnerships to further monetize its portfolio while maintaining strategic control over core assets."By treating delivery infrastructure as a core asset rather than a secondary consideration, Oncotelic is positioning itself within a broader industry move toward integrated solutions that attack the CNS delivery problem head-on.The Growing Weight of Alzheimer's, Neurological DiseaseThe worldwide toll of Alzheimer's disease and other similar forms of dementia is expanding at an alarming pace. According to the World Health Organization, some 57 million people are currently living with dementia globally, a figure projected to grow sharply in the decades ahead as aging populations increase. The human and economic costs of this expansion are substantial, placing mounting pressure on healthcare systems, families, and public finances.Despite this, therapeutic progress has moved slowly. The Alzheimer's Association notes that while researchers have made meaningful strides in understanding the disease at a molecular level, clinical translation has lagged. Drug candidates that look compelling in preclinical settings frequently falter in human trials, often because adequate therapeutic concentrations cannot be sustained within brain tissue, a problem that loops directly back to delivery.New developments across the biopharma landscape highlight both the promise and the stubborn limitations of current approaches. Therapies with demonstrated clinical signals still face ongoing scrutiny over whether effects are consistent and durable, and debates frequently return to the challenge of achieving reliable drug exposure in the brain. These dynamics  support the view that delivery remains one of the defining bottlenecks in CNS medicine.Against this backdrop, Oncotelic Therapeutics is pursuing a position in a segment of the market focused on enabling faster, more reliable access to the brain. By orienting its platform toward targeted and precision delivery, the company is placing itself within a space where solving the delivery problem could substantially improve results across a spectrum of neurodegenerative conditions.Biodefense and the Imperative for Fast CNS InterventionCNS drug delivery is not only a concern for chronic disease, it is also a strategic priority in the area of national security and biodefense. Certain chemical and biological threats act directly on the nervous system, and when they do, the window for effective intervention can be extremely narrow. In these high-stakes scenarios, how fast and how effectively a treatment reaches the brain can mean the difference between survival and catastrophic neurological damage.Federal agencies have taken notice. The Biomedical Advanced Research and Development Authority ("BARDA") plays a leading role in funding medical countermeasure development for chemical, biological, radiological, and nuclear threats. Meanwhile, the U.S. Department of Defense has identified CNS injury treatment and neuroprotection as core research areas, a reflection of the operational importance of maintaining neurological function in personnel exposed to hazardous environments.These policy priorities converge on a shared need: Delivery systems that work fast, bypass conventional physiological obstacles, and ensure therapeutics arrive in the brain at concentrations sufficient to produce meaningful effects. When minutes matter, inefficient delivery translates directly into worsened outcomes.Oncotelic Therapeutics is navigating this landscape by exploring applications of its delivery technology that span both commercial medicine and government-funded biodefense programs. This dual-use potential, which is capable of addressing both civilian neurological diseases and emergency response needs, reflects a broader movement toward versatile platforms that can generate value across multiple high-impact markets.Nose-to-Brain Delivery Emerges as a Leading AlternativeWith conventional drug delivery approaches repeatedly running into BBB-related constraints, alternative methods that circumvent the barrier entirely are attracting growing scientific and commercial interest. Among them, intranasal, or "nose-to-brain," delivery has established itself as a particularly compelling option. This pathway leverages anatomical connections between the nasal passages and the brain to transport therapeutic agents directly into CNS tissue, bypassing the bloodstream altogether.Research highlights the capacity of intranasal delivery systems to meaningfully improve drug transport to the brain while keeping systemic exposure low. Evidence from multiple studies indicates that this approach can raise bioavailability and reduce adverse effects—a combination that makes it attractive for long-term use in neurological conditions where patients require sustained treatment.Industry analysis from Deloitte reinforces this trend, noting that CNS therapeutic innovation is shifting its center of gravity from new molecular entities toward delivery technologies. As pharmaceutical and biotech companies seek more consistent clinical outcomes, the ability to get drugs to the right place in the right amounts is increasingly the variable that separates success from failure.Oncotelic's N2B delivery system embodies this philosophy. Designed as a device-enabled approach to direct CNS delivery, it offers a potential alternative to traditional systemic or intramuscular routes. By bypassing the blood-brain barrier, the platform is engineered to accelerate therapeutic onset and improve targeting of the neurological pathways implicated in both acute biodefense emergencies and chronic conditions like Alzheimer's disease.Platform Strategies Are Reshaping CNS InnovationThe trajectory of CNS drug development is moving away from single-asset bets and toward platform-based architectures that can support multiple therapies, indications and commercial pathways. Unlike conventional drug development models, platform approaches offer scalability and adaptability, both qualities particularly suited to an area such as CNS medicine, where diverse conditions often share the same core delivery challenges.Platform-based models allow companies to spread risk across multiple programs while building on a shared technological foundation. By engineering systems that can be configured for different drugs or conditions, developers create multiple routes to revenue while reducing overexposure to any single program's outcome. This structure also aligns naturally with the principles of precision medicine, in which targeted delivery is integral to achieving outcomes that are both effective and patient-specific.For investors, platform strategies carry a distinct appeal. They offer exposure across a range of markets, including neurodegenerative diseases and biodefense, while creating natural opportunities for partnerships, out-licensing, and monetization. This blend of near-term revenue potential with long-term pipeline value is especially compelling in a sector where timelines are long and the risk of any individual asset failing is high.Oncotelic Therapeutics is building along these lines. Its focus on scalable, adaptable delivery infrastructure positions the company to pursue multiple CNS indications from a shared platform base. By combining short-term monetization strategies, such as the Lunai Bioworks agreement, with longer-term development opportunities, the company reflects an industry-wide shift toward approaches that address both the scientific complexity and the commercial realities of the CNS space.The challenge of delivering drugs to the brain persists as one of the most consequential barriers in contemporary medicine. With Alzheimer's disease caseloads climbing and national attention focusing on biodefense, the demand for faster and more reliable CNS delivery solutions is intensifying. Meeting that demand will require progress not just in discovering new compounds but in reimagining how those compounds are transported to their targets.Companies working to overcome the blood-brain barrier and enable targeted, efficient brain delivery are staking out positions at the leading edge of a significant shift. Oncotelic Therapeutics is one participant in this broader movement, advancing platform-based approaches designed to expand what is therapeutically possible in CNS medicine. As the field continues to evolve, the capacity to deliver drugs reliably and precisely to the brain may well emerge as the central determinant of future medical progress.Biopharma Innovation Continues Advancing TherapeuticsThe biopharma and advanced therapeutics sector continues to see strong momentum as companies expand research pipelines, pursue strategic partnerships and accelerate development of next-generation treatments targeting complex diseases. Recent announcements across oncology, immunology and precision medicine highlight growing investment in innovative biologics, AI-driven drug discovery, targeted therapies and advanced platform technologies designed to improve outcomes for patients with difficult-to-treat conditions.Amgen Inc. (NASDAQ: AMGN) has acquired Dark Blue Therapeutics, a move that will bolster the company's oncology pipeline and expand its capabilities in targeted protein degradation and leukemia therapeutics. The company noted that acute myeloid leukemia remains one of the most difficult cancers to treat and that the acquisition complements and extends its research in targeted protein degradation and leukemia therapeutics, as well as advances its strategy to invest in novel therapeutic targets and next-generation oncology medicines designed to address difficult-to-treat cancers.Johnson & Johnson (NYSE: JNJ) continues advancing its position in the biopharma and advanced therapeutics space through its Innovative Medicine division, which the company describes as "leading where medicine is going." According to JNJ, patients inform and inspire the company's science-based innovations, which continue to change and save lives with rigorous science and compassion by addressing the most complex diseases and focusing on unlock the medicines of tomorrow. The company's areas of healthcare focus include oncology, immunology, neuroscience and cardiopulmonary.AbbVie Inc. (NYSE: ABBV) has entered an exclusive licensing agreement with RemeGen for the development, manufacturing and commercialization of RC148, a novel investigational Programmed Cell Death-1 ("PD-1")/Vascular Endothelial Growth Factor ("VEGF")-targeted bispecific antibody. RC148 is being developed both as a monotherapy and in combination regimens across multiple advanced solid tumors, reinforcing the company's continued expansion in next-generation oncology therapeutics. The agreement reflects AbbVie's strategy to strengthen its oncology pipeline through innovative biologics and advanced immunotherapy approaches targeting difficult cancers.Lunai Bioworks Inc. (NASDAQ: LNAI) announced the launch of an AI oncology pilot with a clinical-stage partner to analyze randomized phase 2 metastatic colorectal cancer survival trial data. The objective of the partnership is to define biologically meaningful patient subgroups that may benefit most from the investigational therapy. Under the pilot agreement, Lunai will deploy its proprietary Augusta AI platform to evaluate de-identified patient-level clinical, imaging, and longitudinal outcomes data, with a focus on overall survival and disease progression endpoints. By integrating traditional clinical variables with AI-derived imaging features and temporal response patterns, Lunai aims to generate data-driven enrichment strategies designed aid in the FDA trial design, including optimized inclusion criteria, endpoint strategy, and its statistical powering.These developments reflect the increasing importance of scientific innovation, data-driven discovery and advanced therapeutic modalities in shaping the future of medicine. As the industry continues evolving toward more personalized, targeted and technology-enabled approaches, companies operating in the space are positioning themselves to play a major role in advancing treatment options across a broad range of serious diseases.For further information about Oncotelic Therapeutics Inc., visit the Oncotelic Therapeutics profile.About BioMedWireBioMedWire ("BMW") is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. 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Johnson & Johnson Advances the Standard of Calcium Modification with Global Launch of Shockwave™ C2 Aero Coronary IVL CatheterMay 12, 2026 7:45 AM
Business Wire Next-generation intravascular lithotripsy (IVL) catheter resets physicians’ expectations by addressing unmet needs in deliverability, lesion crossing and balloon repositioning Shockwave C2 Aero enables clinicians to extend Shockwave IVL’s clinically-validated mechanism of action to a broader spectrum of calcified coronary lesions Johnson & Johnson (NYSE: JNJ) announced today the global launch of its Shockwave C2 Aero Coronary IVL Catheter designed for improved deliverability, enhanced lesion crossing and new repositioning capabilities for the treatment of calcified coronary artery disease (CAD).1,2,3 The next-generation coronary IVL catheter leverages Shockwave IVL’s unique mechanism of action and the safety and effectiveness profile of its legacy catheters, expanding the company’s market-leading IVL portfolio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260512562027/en/Shockwave C2 Aero, a next generation coronary IVL catheter addresses unmet needs in deliverability, lesion crossing, and balloon repositioning. CAD is the leading cause of death globally, affecting an estimated 315 million people worldwide and approximately 1 in 20 adults over the age of 20 in the U.S.4,5,6 In CAD, progressive buildup of cholesterol deposits gradually narrows the vessels, reducing blood flow to the heart muscle and leading to chest pain (angina) and heart attacks. Over time, cholesterol deposits may accumulate calcium and harden, making them difficult to treat with conventional techniques. Further challenges arise in cases with tortuous arteries and severe calcification, which can prevent modification tools from navigating and crossing the lesion. “Shockwave C2 Aero makes it easier to navigate tortuous coronary anatomy without relying on additional upfront ancillary devices. That enhanced deliverability and efficiency can change IVL use and expand its role in treatment algorithms,” said Margaret McEntegart, M.D., Ph.D., Director of Complex Percutaneous Coronary Intervention Program at Columbia University Medical Center/New York-Presbyterian Hospital.7 “By continuing to address real unmet physician needs like deliverability, crossability and repositioning, Johnson & Johnson is pushing expectations for what the technology can achieve in complex PCI procedures.” Shockwave C2 Aero provides physicians with greater flexibility and efficiency in treatment strategy by:1 Enhancing deliverability through tight, tortuous arteries via more flexible shaft, balloon and marker bands. 1 Easing entry and crossing of dense calcified deposits with its tapered tip and new hydrophilic coating. 2 Allowing repositioning within the coronary anatomy to treat additional lesions due to the new balloon material designed for more compact deflation. 3 “In earlier iterations of the technology, physicians often had to rely on additional ancillary devices to achieve optimal positioning, and treatment was generally limited to a distal-to-proximal approach in coronary lesions,” said Benjamin Honton, M.D., Interventional Cardiologist at Clinique Pasteur, Toulouse, France.8 “The balloon rewrap capability of the Shockwave C2 Aero enables easier repositioning, allowing both proximal and distal movement within the vessel, as well as lesion recrossing when needed. This added flexibility facilitates the treatment of more complex patterns of calcification and supports more tailored pulse delivery strategies, including in multivessel disease, expanding what can be achieved with intravascular lithotripsy.” Shockwave C2 Aero has a working length of 138 centimeters and features two emitters encased in an integrated balloon that fire simultaneously up to 120 pulses, delivering up to 240 Shockwaves. Each Shockwave pulse creates ultrasonic acoustic pressure waves that pass through soft tissue and crack hardened calcium in place, helping to re-establish blood flow in the blocked artery. “We’re redefining standards for coronary IVL with more efficient and predictable overall procedures in challenging cases when it matters most,” said Isaac Zacharias, President, Shockwave Medical, MedTech, Johnson & Johnson. “As others prepare to enter the coronary IVL market, Johnson & Johnson is raising the bar with our fifth-generation platform built on years of physician feedback, sustained R&D advancements and robust clinical validation of our unique mechanism of action that reinforce our IVL leadership.” Shockwave C2 Aero is now available in the United States and Japan and will be available in Europe and Canada in the coming months. The next-generation coronary IVL technology will be featured in the booth from Shockwave Medical, part of Johnson & Johnson, at EuroPCR 2026 taking place in Paris, France from May 19-22, 2026. About Shockwave Medical
Shockwave Medical Inc., part of Johnson & Johnson, is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using ultrasonic acoustic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Its Reducer technology, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom, is designed to provide relief to the millions of patients worldwide suffering from refractory angina by redistributing blood flow within the heart. Learn more at www.shockwavemedical.com. About Cardiovascular Solutions from Johnson & Johnson
Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://www.jnjmedtech.com/en-US/. Follow us at @JNJMedTech and on LinkedIn. Shockwave Medical, Inc. is a Johnson & Johnson company. Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to Shockwave C2 Aero Coronary IVL Catheter. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. ______________________________ 1 Compared to Shockwave C2+ in simulated use bench testing. Based on feedback from physicians who participated in the Limited Market Release Survey 2 Designed with more tapered tip and new hydrophilic coating compared to Shockwave C2+ 3 Designed with more flexible material compared to Shockwave C2+ 4 Centers for Disease Control and Prevention. About Coronary Artery Disease (CAD). https://www.cdc.gov/heart-disease/about/coronary-artery-disease.html. Last Accessed: March 24, 2025. 5 Centers for Disease Control and Prevention. Heart Disease Facts. https://www.cdc.gov/heart-disease/data-research/facts-stats/index.html. Last Accessed: March 24, 2025. 6 https://www.jacc.org/doi/10.1016/S0735-1097%2824%2904310-9 7 Dr. Margaret McEntegart is a paid consultant for Shockwave Medical. She has not been compensated in connection with this press release. 8 Dr. Benjamin Honton is a paid consultant for Shockwave Medical. He has not been compensated in connection with this press release.   View source version on businesswire.com: https://www.businesswire.com/news/home/20260512562027/en/ Media Contact:
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Investor-relations@its.jnj.com Original: Johnson & Johnson Advances the Standard of Calcium Modification with Global Launch of Shockwave™ C2 Aero Coronary IVL Catheter

Johnson & Johnson to Participate in the Goldman Sachs 47th Annual Global Healthcare ConferenceMay 11, 2026 4:34 PM
Business Wire Johnson & Johnson (NYSE: JNJ) will participate in the Goldman Sachs 47th Annual Global Healthcare Conference on Tuesday, June 9th, 2026. Management will participate in a Fireside Chat at 10:00 a.m. Eastern Time. This live audio webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com. The audio webcast replay will be available approximately 48 hours after the webcast. View source version on businesswire.com: https://www.businesswire.com/news/home/20260511295368/en/ Media contact:
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investor-relations@its.jnj.com Original: Johnson & Johnson to Participate in the Goldman Sachs 47th Annual Global Healthcare Conference

Johnson & Johnson study shows TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to demonstrate efficacy in perianal fistulizing Crohn's diseaseMay 5, 2026 8:05 AM
PR Newswire (US) TREMFYA® demonstrated significantly higher rates of combined fistula remission – complete external closure of draining fistulas and absence of fluid collection on MRI – compared to placebo at Week 24First study of its kind in 20 years for this debilitating manifestation of Crohn's disease presented as late-breaking data at Digestive Disease Week 2026CHICAGO, May 5, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced results from the Phase 3 FUZION study evaluating TREMFYA® (guselkumab) in adults with active perianal fistulizing Crohn's disease (CD). At Week 24, TREMFYA demonstrated significantly higher rates of combined fistula remission, a highly stringent endpoint defined as complete external closure of draining fistulas and absence of fluid collection on MRI, compared to placebo.1 Remission in patients with this complicated manifestation remains difficult to achieve, and this is the first randomized control trial of an approved therapy in inflammatory bowel disease (IBD) that demonstrates efficacy in adults with active perianal fistulizing Crohn's disease in 20 years. These late-breaking data are among the 32 company-sponsored abstracts at Digestive Disease Week (DDW) 2026. Key findings from the FUZION study
TREMFYA met the primary endpoint of combined fistula remission at Week 24, defined as complete closure of all external fistula openings with no drainage, without development of new fistulas and no evidence of underlying fluid collections on MRI.a Combined fistula remission was achieved by 28.3% of patients receiving TREMFYA 100 mg every 8 weeks (q8w) and 27.0% of patients receiving TREMFYA 200 mg every 4 weeks (q4w), compared with 10.3% for placebo.The treatment differences versus placebo were statistically significant for both the 100 mg q8w and 200 mg q4w dosing regimens (p=0.007 and p=0.013, respectively). Adverse events through 24 weeks were consistent with the known safety profile of TREMFYA in CD."The pain, swelling and persistent drainage associated with perianal fistulizing Crohn's disease can be profoundly disruptive to patients' daily lives," said Laurent Peyrin-Biroulet, MD, PhD, study investigator.b "Achieving durable fistula closure without repeated surgical interventions remains a significant unmet need. The results from the FUZION study demonstrate the ability of TREMFYA to achieve combined fistula remission, which is an exciting step forward for patients, expanding what's possible for managing this debilitating and chronic condition.""It has been more than two decades since a highly rigorous study has been dedicated to perianal fistulizing Crohn's disease, a very difficult-to-treat and complex manifestation of this already challenging condition," said Ludovic de Beaucoudrey, PhD, J&J Innovative Medicine Vice President, Immunology, Global Medical Affairs, Gastroenterology and Autoantibody. "Building on decades of experience in immunology, Johnson & Johnson continues to address areas of significant unmet need, and the FUZION study reflects our commitment to delivering meaningful, evidence-based advances for patients and the healthcare providers who care for them."Addressing a significant unmet need in perianal fistulizing Crohn's disease
A fistula is an abnormal connection or tunnel that develops between the intestine and another organ or the skin, typically arising when inflammation causes ulceration in the intestinal wall or surrounding tissue. Over time, these ulcers may penetrate the full thickness of the bowel, forming a channel that allows infected material to drain. Perianal fistulizing Crohn's disease affects nearly 25% of patients with CD and represents a severe, often debilitating manifestation of the disease that has profound impacts on a person's physical and mental health.2,3 It is characterized by pain, swelling, persistent drainage, recurrent abscesses, and a frequent need for surgical intervention.As another example of this commitment for evidence-based advances for CD patients and providers, Johnson & Johnson is also initiating the CHARGE study, the first head-to-head study of IL-23 inhibitors in IBD, which will evaluate TREMFYA compared to risankizumab in treatment of Crohn's disease. Trial sites are now open for patient enrollment. For more information, visit ClinicalTrials.gov.With the addition of the results from the breakthrough Phase 2b DUET studies in CD and UC, Johnson & Johnson products were featured in three late-breaking abstracts at DDW.4,5 For a full list of all Johnson & Johnson data being presented at DDW visit: https://www.jnj.com/innovativemedicine/immunology/gastroenterology.Editor's Notes: a. Defined as >2cm of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the MRI results.
b. Dr. Laurent Peyrin-Biroulet is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.About the FUZION study (NCT05347095)
FUZION is a randomized, placebo-controlled, double-blind, multicenter, Phase 3 study designed to evaluate the efficacy and safety of TREMFYA in adults with perianal fistulizing Crohn's disease. Patients enrolled in the study had one or more active draining perianal fistulas confirmed by blinded central MRI review, CD Activity Index [CDAI]

Johnson & Johnson investigational co-antibody therapy JNJ-4804 shows potential to raise the bar for clinical efficacy in treating refractory inflammatory bowel diseaseMay 5, 2026 8:05 AM
PR Newswire (US) JNJ-4804 demonstrated highest rates of clinical and endoscopic outcomes compared to golimumab and guselkumab in patients with ulcerative colitis or Crohn's disease who have had inadequate response to two or more systemic therapy classesJNJ-4804 is the first and only fixed dose co-antibody designed to deliver molecular synergy in IBD by blocking the complementary IL-23 and TNF pathwaysData from Phase 2b DUET studies show potential to address a critical unmet need and support advancement to Phase 3 trialsCHICAGO, May 5, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced Phase 2b data from two studies evaluating JNJ-4804, an investigational co-antibody therapy targeting both interleukin-23 (IL-23) and tumor necrosis factor-alpha (TNF-a), in patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) that is refractory to systemic therapies.1,2 The late-breaking presentations from the DUET-UC and DUET-CD studies were among the 32 company-sponsored abstracts being presented at Digestive Disease Week (DDW) 2026. In both studies at Week 48, JNJ-4804 showed meaningful improvements across multiple clinical and endoscopic measures for a subpopulation of patients who are considered highly refractory and have had inadequate response to two or more systemic therapy classes.DUET-CD study
In the overall population, JNJ-4804a demonstrated higher clinical remissionb rates (50.8%) and endoscopic responsec rates (38.1%) versus golimumab (25.4% for clinical remission, 19.8% for endoscopic response) at Week 48. The JNJ-4804 rates were also numerically higher than the rates achieved with guselkumab (42.5% for clinical remission and 33.9% for endoscopic response). In the highly refractory subpopulation of patients with CD who have had inadequate response to two or more systemic therapy classes, JNJ-4804 showed clinically meaningful improvements at Week 48 across multiple clinical and endoscopic endpoints compared to golimumab and guselkumab monotherapies, and placebo. Clinical remission rates for JNJ-4804 were nearly double the highest comparator and more than 60% higher in endoscopic response rate."Despite many treatment advances for Crohn's disease over the past two decades, many patients do not achieve long-term disease control with the currently available options, even after trying multiple monotherapies with different classes," said Bruce E. Sands, MD, MS, Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine, and Chief, Division of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Health System and presenting author of the DUET-CD study. "The results from DUET-CD are particularly promising because they show meaningful clinical and endoscopic improvements in patients who have exhausted existing options."DUET-UC study
In the overall population, JNJ-4804a demonstrated superior clinical remissiond rates compared to golimumab, with 41.0% of JNJ-4804-treated patients achieving clinical remission at Week 48 versus golimumab (11.5%), and numerically higher rates than guselkumab (34.0%).In the highly refractory subpopulation of patients with UC who have had inadequate response to two or more systemic therapy classes, JNJ-4804 showed clinically meaningful improvements at Week 48 across multiple clinical and endoscopic endpoints compared to golimumab and guselkumab monotherapies, and placebo, with the clinical remission rate for JNJ-4804 being almost 60% higher than the closest comparator."There is a major unmet need for patients who either don't respond or are no longer responding to current UC treatments," said Dr. Maria Abreu, Executive Director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai in Los Angeles and presenting author of DUET-UC. "The ongoing symptoms patients face when their UC is uncontrolled can profoundly impact their lives. The improvements we saw in DUET-UC are very encouraging, offering a potential new approach for patients with few options for long-term disease control." In both studies, safety findings were generally consistent with the known profiles of the component monotherapies.Addressing an unmet need in refractory inflammatory bowel disease (IBD)
Inflammatory bowel disease, including UC and CD, affects millions of people worldwide. While advances in biologics and targeted therapies have improved outcomes for many patients, many individuals either no longer respond or lose response over time.3 It is common for patients to cycle through multiple therapies while experiencing diminishing efficacy, leading to persistent symptoms such as abdominal pain, urgency, and bleeding. Ongoing inflammation can lead to irreversible bowel damage, hospitalization, and surgeries.4 These challenges highlight a critical need for new treatments that can deliver meaningful disease control for patients who have been refractory to treatment with monotherapies. "Inflammatory bowel disease involves multiple inflammatory pathways, which may help explain why some patients don't respond or lose response to existing monotherapies," said Esi Lamousé Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson. "By targeting the orthogonal pathways of IL-23 and TNFa, JNJ-4804 yields a synergistic therapeutic approach. The results from the DUET studies highlight its potential to change the treatment landscape."Based on results from the Phase 2b DUET studies, Johnson & Johnson will be initiating the Phase 3 DUET ENCORE-CD trial in adults with moderately to severely active CD as well as the Phase 3 DUET ENCORE-UC trial in adults with moderately to severely active UC.With these data, in addition to results from the Phase 3 FUZION study of TREMFYA® (guselkumab) in perianal fistulizing Crohn's disease, Johnson & Johnson therapies account for three late-breaking abstracts featured at DDW.5(Dr. Bruce E. Sands and Dr. Maria Abreau are paid consultants for Johnson & Johnson. They have not been compensated for any media work).For a full list of all Johnson & Johnson data being presented at DDW visit:  https://www.jnj.com/innovativemedicine/immunology/gastroenterology.Editor's Notes: a. Data represents the JNJ-4804 high dose group.
b. Clinical remission was defined as a CDAI score of 50% improvement from baseline in SES-CD or an SES-CD ≤2, as assessed by central endoscopy reading.
d. Clinical remission was defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 per central review of the video endoscopy. About the DUET-UC and DUET-CD studies
The DUET-UC (ulcerative colitis) and DUET-CD (Crohn's disease) studies are randomized, double-blind, dose-ranging Phase 2b studies comparing JNJ-4804 with placebo and active comparators, including guselkumab and golimumab. Patients enrolled in both studies had moderately to severely active disease with inadequate response or intolerance to one or more systemic therapy classes, including biologics and targeted oral therapies. Approximately half of participants in each study had previously experienced inadequate response to two or more therapy classes, representing a highly treatment-experienced population. The Phase 2b DUET clinical program builds on earlier proof-of-concept findings from the Phase 2a VEGA study and is intended to inform potential registrational trials.6,7,8The primary endpoint of DUET-UC was clinical remission at Week 48. Key secondary endpoints included corticosteroid-free clinical remission, endoscopic improvement, histologic remission and endoscopic improvement (HREI) at Week 48.1 The co-primary endpoints of DUET-CD were clinical remission at Week 48 and endoscopic response at Week 48. Key endpoints included endoscopic remission, deep remission and corticosteroid-free clinical remission at Week 48.2  About JNJ-4804
JNJ-4804 is an investigational co-antibody therapy designed to target both interleukin-23 (IL-23) and tumor necrosis factor-alpha (TNF-a), two inflammatory pathways involved in chronic immune-mediated diseases. JNJ-4804 is a fixed-dose combination of two proven therapies, guselkumab and golimumab, in a single, subcutaneous (SC) injection. JNJ-4804 is being studied in the Phase 2b DUET clinical program in inflammatory bowel disease and the Phase 2a AFFINITY study in active psoriatic arthritis (PsA). About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue. Currently there is no cure available for UC. 9About Crohn's Disease 
Crohn's disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans and an estimated four million people across Europe.10,11 Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.12 Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently no cure is available for Crohn's disease.13ABOUT TREMFYA® (guselkumab)
Developed by Johnson & Johnson, TREMFYA is the first fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for the dual-acting mechanism are limited to in vitro  studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA is a prescription medicine approved in the U.S. to treat: adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with moderate to severe plaque psoriasis who may?benefit?from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).?adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with active psoriatic arthritis.?adults with moderately to severely active ulcerative colitis.?adults with moderately to severely active Crohn's disease. ? ?TREMFYA is approved in Europe, Canada, Japan, and?a number of?other countries for the treatment of adults with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderate-to-severe Crohn's disease and adults with moderate-to-severe ulcerative colitis.?The legal manufacturer for TREMFYA is Janssen Biotech, Inc.  Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA. For more information, visit:  www.tremfya.com . IMPORTANT SAFETY INFORMATION? What is the most?important information?I should know about TREMFYA?? TREMFYA?is a prescription medicine that may cause serious side effects, including:? Serious Allergic Reactions.?Stop using TREMFYA?and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:? o fainting, dizziness, feeling lightheaded (low blood pressure)? o swelling?of your face, eyelids, lips, mouth,?tongue?or throat? o trouble breathing or throat tightness? o chest tightness? o skin rash, hives? o itching? Infections.?TREMFYA?may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA?and may treat you for TB before you begin treatment with TREMFYA?if you have a history of TB or?have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA.? Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:? o fever, sweats, or chills? o muscle aches? o weight loss? o cough? o warm, red, or painful skin or sores on your body different from your psoriasis? o diarrhea or stomach pain? o shortness of breath? o blood in your phlegm (mucus)? o burning?when you urinate or urinating more often than normal? Liver problems.?With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA. Your healthcare provider may stop treatment with TREMFYA?if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:? o unexplained rash? o vomiting? o tiredness (fatigue)? o yellowing?of the skin or the whites of your eyes? o?nausea? o?stomach?pain?(abdominal)? o loss of?appetite? o dark urine? Do not use TREMFYA?if you have had a serious allergic reaction to?guselkumab?or any of the ingredients in TREMFYA.? Before using TREMFYA, tell your healthcare provider about?all of?your medical conditions, including if you:? have any of the conditions or symptoms listed in the section?"What is the most important information I should know about TREMFYA?"? have?an infection that does not go away?or that?keeps coming back.? have?TB or have been in close contact with someone with?TB.? have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA.? are pregnant or plan to become pregnant. It is not known if TREMFYA?can harm your unborn baby.? 
Pregnancy Registry: If you become pregnant during treatment with TREMFYA, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA. You can enroll by visiting?www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling??1-877-311-8972, or emailing?MotherToBaby@health.ucsd.edu. The purpose of this registry is to collect information about the safety of TREMFYA?during pregnancy.? are breastfeeding?or plan to breastfeed. It is not known if TREMFYA?passes into your breast milk.? Tell your healthcare provider about all the medicines you take,?including prescription and over-the-counter medicines, vitamins, and herbal supplements.? What are the possible side effects of TREMFYA?? TREMFYA may cause serious side effects. See "What is the most important information I should know about TREMFYA?"? The most common side effects of TREMFYA?include:?respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, and bronchitis.? These are not all the possible side effects of TREMFYA. Call your doctor for medical advice about side effects.? Use TREMFYA®?exactly as your healthcare provider tells you to use it.? Please read the full?Prescribing Information, including?Medication Guide, for TREMFYA?and discuss any questions that you have with your doctor.? You are encouraged to report negative side effects of prescription drugs to the FDA. Visit?www.fda.gov/medwatch, or call?1-800-FDA-1088.? Dosage Forms and Strengths: TREMFYA?is available?as?100 mg/mL and 200 mg/2mL for subcutaneous?injection?and as a?200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion.? ABOUT JOHNSON & JOHNSON  
At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.??? Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com? Follow us at?@JNJInnovMed.Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to JNJ-4804 and TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.References:
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1 Maria T. Abreu, et al. Efficacy And Safety Of The First Co-Antibody Therapy, Jnj-78934804, In Patients With Moderately To Severely Active Ulcerative Colitis Refractory To Systemic Therapies. (Abstract 1058d) Presented at Digestive Disease Week (DDW) May 2-5, 2026.  
2 Sands BE, et al. Efficacy And Safety Of The First Co-Antibody Therapy, Jnj-78934804, In Patients With Moderately To Severely Active Crohn's Disease Refractory To Systemic Therapies. (Abstract 979f) Presented at Digestive Disease Week (DDW) May 2-5, 2026. 
3 Chapman C, et al.Real-World Dosing Patterns Of Biologics In Crohn's Disease And Ulcerative Colitis: A Retrospective Observational Study Gastroenterology, 168S12. https://doi.org/10.1053/j.gastro.2025.01.070
4 Raine T. et al. ECCO Topical Review: Refractory Inflammatory Bowel Disease,?Journal of Crohn's and Colitis, Volume 15, Issue 10, October 2021, Pages 1605–1620,?https://doi.org/10.1093/ecco-jcc/jjab112
5 Laurent Peyrin-Biroulet, et al. Guselkumab For Perianal Fistulizing Crohn's Disease: Week 24 Results From The Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Fuzion Study (Abstract 1058b), Presented at Digestive Disease Week (DDW) May 2-5, 2026.
6 Panés J,?et al.?Induction Combination Therapy with Guselkumab and Golimumab Followed by Guselkumab Monotherapy Maintenance: Results of the Phase 2a, Randomized, Double-blind, Proof-of-concept VEGA Study (Abstract OP087). Presented at the United European Gastroenterology (UEG) Week, October 10, 2022.
7 Clinicaltrials.gov. A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (DUET-CD). Identifier:  NCT05242471. Available at: https://clinicaltrials.gov/study/NCT05242471. 
8 Clinicaltrials.gov. A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (DUET-UC). Identifier: NCT05242484. Available at:? https://clinicaltrials.gov/study/NCT05242484.
9 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis. Accessed May 2026.
10 Crohn's & Colitis Foundation. Overview of Crohn's disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed May 2026.
11 Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet. 2017;390:2769-78.
12 Crohn's & Colitis Foundation. What is Crohn's disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed February 2026.
13 Crohn's & Colitis Foundation. Signs and symptoms of Crohn's disease. Available at https://www.crohnscolitisfoundation.org/patientsandcaregivers/what-is-crohns-disease/symptoms. Accessed February 2026.Media contact:  Investor contact:Craig Stoltz   Jess Margevichcstoltz@its.jnj.com   investor-relations@its.jnj.com View original content to download multimedia:https://www.prnewswire.com/news-releases/johnson--johnson-investigational-co-antibody-therapy-jnj-4804-shows-potential-to-raise-the-bar-for-clinical-efficacy-in-treating-refractory-inflammatory-bowel-disease-302761831.htmlSOURCE Johnson & Johnson Original: Johnson & Johnson investigational co-antibody therapy JNJ-4804 shows potential to raise the bar for clinical efficacy in treating refractory inflammatory bowel disease

It's been good not sure how much more left in tank but still holding for now

Johnson & Johnson to Participate in the Bernstein’s 42nd Annual Strategic Decisions ConferenceApril 27, 2026 4:33 PM
Business Wire
Johnson & Johnson (NYSE: JNJ) will present at the Bernstein’s 42nd Annual Strategic Decisions Conference on Wednesday, May 27th, 2026. Management will participate in a Fireside Chat at 11:00 a.m. Eastern Time.


A live audio webcast of the presentation will be accessible through Johnson & Johnson’s Investor Relations website at www.investor.jnj.com. An archived edition of the session will be available later that day.


The audio webcast replay will be available approximately 48 hours after the webcast.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260427510768/en/
Media contact:

media-relations@its.jnj.com


Investor contact:

investor-relations@its.jnj.com


Original: Johnson & Johnson to Participate in the Bernstein’s 42nd Annual Strategic Decisions Conference

FDA grants Priority Review for IMAAVY® (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA)April 27, 2026 8:03 AM
PR Newswire (US)

Priority Review is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions like warm autoimmune hemolytic anemia, a life-threatening disease in which pathogenic immunoglobulin G autoantibodies attach to and destroy red blood cells, leading to debilitating anemiaIMAAVY is designed to target the underlying cause of warm autoimmune hemolytic anemia by reducing circulating immunoglobulin G, including autoantibodies, while preserving critical immune functions Pivotal study showed rapid and durable hemoglobin responsea and fatigue improvementb compared to placebo in patients with warm autoimmune hemolytic anemiaSPRING HOUSE, Pa., April 27, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for IMAAVY® (nipocalimab-aahu),c confirming the urgent need for treatment options in warm autoimmune hemolytic anemia (wAIHA). Priority Review is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions and shortens the FDA review timeline to approximately six months.1 IMAAVY is the first therapy to receive FDA Priority Review for this condition.







"Warm autoimmune hemolytic anemia is a severe disease in which pathogenic immunoglobulin G (IgG) antibodies, also called autoantibodies, drive destruction of red blood cells. Currently, patients depend on broad immunosuppressive therapies that fail to address the underlying cause of disease and are not approved as safe or effective to treat wAIHA," said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson. "This designation highlights both the serious, life-threatening nature of wAIHA and the potential for IMAAVY, if approved, to help address a critical unmet need by delivering clinically meaningful outcomes for patients."IMAAVY is designed to block the neonatal Fc receptor (FcRn), reducing circulating IgG, including pathogenic autoantibodies, while preserving key immune functions.2,3 By targeting the underlying driver of disease, IMAAVY utilizes a differentiated immunoselective approach in a condition where many patients currently rely on therapies that are unapproved for wAIHA, including corticosteroids and broad immunosuppressants.4The FDA's decision to grant Priority Review is supported by results from the pivotal Phase 2/3 ENERGY study, which showed that more patients treated with IMAAVY achieved a durable hemoglobin responsea compared with placebo, along with improvements in fatigue,b a critical outcome for people living with wAIHA.5 The full results of the ENERGY trial will be presented at an upcoming medical conference.Nipocalimab is being studied across multiple auto- and alloantibody-driven diseases as part of Johnson & Johnson's broader commitment to advancing transformational immunology therapies.Editor's Notes: a. Durable hemoglobin response = hemoglobin concentration ≥10 g/dL and an increase from baseline in hemoglobin ≥2 g/dL for at least 28 days
b. As measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
c. IMAAVY is not approved by the U.S. FDA for the treatment of wAIHAABOUT THE ENERGY TRIAL
ENERGY (NCT04119050) is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study evaluating the efficacy and safety of nipocalimab compared with placebo, followed by an open-label extension period, in adults living with warm autoimmune hemolytic anemia (wAIHA).5ABOUT WARM AUTOIMMUNE HEMOLYTIC ANEMIA (wAIHA)
Warm autoimmune hemolytic anemia (wAIHA) is a rare, life-threatening condition where autoantibodies attach to and destroy red blood cells (RBCs), resulting in anemia. Approximately 1-3 new people per 100,000 are affected by wAIHA per year, and about 1 in 8,000 individuals are living with the condition.4,6 This condition affects both women and men, and can affect people at any age with incidence increasing over the age of 50.7,8 Additionally, people with wAIHA are at increased risk of other serious complications such as venous thrombotic events, acute renal failure, and infection.9There are no Food and Drug Administration (FDA)-approved drugs indicated for wAIHA, and treatment typically consists of unapproved corticosteroids, broad immunosuppressants, and B-cell directed therapies.4 With an unmet need for treatment in wAIHA, novel therapies like nipocalimab are being developed to potentially address this need.8ABOUT IMAAVY (nipocalimab-aahu)
IMAAVY is an immunoselective treatment designed to target, bind with high affinity, and block the neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving key immune functions. IMAAVY is currently approved for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.10Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases, and Maternal Fetal diseases mediated by maternal alloantibodies, in which blockade of IgG binding to FcRn in the placenta is believed to limit transplacental transfer of maternal alloantibodies to the fetus.11,12,13,14,15,16,17,18,19,20The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:  EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025U.S. FDA Fast Track designation in HDFN and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, FNAIT in March 2024, Sjögren's disease (SjD) in March 2025, and systemic lupus erythematosus (SLE) in January 2026U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024  U.S. FDA granted Priority Review in gMG in Q4 2024 and wAIHA in Q2 2026The legal manufacturer for IMAAVY is Janssen Biotech, Inc.WHAT IS IMAAVY (nipocalimab-aahu)?
IMAAVY is a prescription medicine used to treat adults and children 12 years of age and older with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.It is not known if IMAAVY is safe and effective in children under 12 years of age.IMPORTANT SAFETY INFORMATION What is the most important information I should know about IMAAVY?IMAAVY is a prescription medicine that may cause serious side effects, including:Infections are a common side effect of IMAAVY that can be serious. Receiving IMAAVY may increase your risk of infection. Tell your healthcare provider right away if you have any of the following infection symptoms: feverchillsshiveringcough sore throatfever blistersburning when you urinateAllergic (hypersensitivity) reactions may happen during or up to a few weeks after your IMAAVY infusion. Get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion: a swollen face, lips, mouth, tongue, or throatdifficulty swallowing or breathing itchy rash (hives)chest pain or tightnessInfusion-related reactions are possible. Tell your healthcare provider right away if you get any of these symptoms during or a few days after your IMAAVY infusion: headacherashnauseafatigue dizzinesschillsflu-like symptomsredness of skinDo not receive IMAAVY if you have a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY®. Reactions have included angioedema and anaphylaxis.Before using IMAAVY, tell your healthcare provider about all of your medical conditions, including if you:ever had an allergic reaction to IMAAVY.have or had any recent infections or symptoms of infection.have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY should not receive live vaccines.are pregnant, plan to become pregnant, or are breastfeeding. It is not known whether IMAAVY will harm your baby.Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY if IMAAVY is given during pregnancy or you become pregnant while receiving IMAAVY. Your healthcare provider should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.What are the possible side effects of IMAAVY?
IMAAVY may cause serious side effects. See "What is the most important information I should know about IMAAVY?"The most common side effects of IMAAVY include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.These are not all the possible side effects of IMAAVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.Please see the full Prescribing Information and Medication Guide for IMAAVY and discuss any questions you have with your doctor.Dosage Form and Strengths: IMAAVY is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.  Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com.Follow us at @JNJInnovMed.  Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen Global Services, LLC are Johnson & Johnson companies. For full financial data, non-GAAP reconciliations and cautionary statements, please refer to Johnson & Johnson's earnings release issued on April 14, 2026 available at https://www.investor.jnj.com/financials/quarterly-results/default.aspxCaution Concerning Forward-Looking StatementsThis document contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding future operating and financial performance. You are cautioned not to rely on these forward-looking statements, which are based on current expectations of future events. For important information about the risks and uncertainties that could cause actual results to vary materially from the assumptions, expectations, and projections expressed in any forward-looking statements, review the "Note to Investors Concerning Forward-Looking Statements" included in the Johnson & Johnson earnings release issued on April 14, 2026 as well as the most recently filed Johnson & Johnson Reports on Forms 10-K and 10-Q. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.1 U.S. Food & Drug Administration. Priority Review. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Last accessed: April 2026.
2 Ling LE., et al. M281, an anti-fcrn antibody: Pharmacodynamics, pharmacokinetics, and safety across the full range of IGG reduction in a first-in-human study. Clinical Pharmacology & Therapeutics., 2018;105;4:1031–1039. Available at: https://doi.org/10.1002/cpt.1276.
3 Cossu M et al. A randomized, open-label study on the effect of nipocalimab vaccine response in healthy participants. Presentation at American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. October 2024.
4 Sudulagunta SR, et al. Warm Autoimmune Hemolytic Anemia: Clinical Profile and Management. J Hematol. 2017 Mar; 6(1): 12–20. Published online 2017 Mar 21. doi: 10.14740/jh303w.
5 ClinicalTrials.gov Identifier: NCT04119050. Available at: https://www.clinicaltrials.gov/study/NCT04119050
6 Tranekær S, Hansen DL, Frederiksen H. Epidemiology of secondary warm autoimmune haemolytic anaemia-A systematic review and meta-analysis. J Clin Med. 2021 Mar 17;10(6):1244. doi:10.3390/jcm10061244. PMID: 33802848; PMCID: PMC8002719.
7 National Organization for Rare Disorders, Warm autoimmune Hemolytic Anemia. Available at: https://rarediseases.org/rare-diseases/warm-autoimmune-hemolytic-anemia/. Last accessed: April 2026.
8 Cherif H, Ca Q, Crivera C, Leon A, Rahman I, Leval A, Noel W, Kjellander C. Overall survival and treatment patterns among patients with warm autoimmune hemolytic anemia in Sweden: A nationwide population-based study. 2024.
9 Fattizzo B, Barcellini W. New therapies for the treatment of warm autoimmune hemolytic anemia. Transfusion Medical Reviews. 2022;36(4). https://doi.org/10.1016/j.tmrv.2022.08.001
10 IMAAVY® U.S. Prescribing Information.
11 ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622. Last accessed: April 2026.
12 ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: April 2026.
13 ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: April 2026.
14 ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050. Last accessed: April 2026.
15 ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: April 2026.
16 ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: April 2026.
17 ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: April 2026.
18 ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: April 2026.
19 ClinicalTrials.gov Identifier: NCT06449651. Available at: https://clinicaltrials.gov/study/NCT06449651. Last accessed: April 2026.
20 ClinicalTrials.gov Identifier: NCT06533098 Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: April 2026.Media contact:
Bridget Kimmelbkimmel@its.jnj.com Investor contact:
Jessica Margevichinvestor-relations@its.jnj.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/fda-grants-priority-review-for-imaavy-nipocalimab-aahu-as-the-potential-first-approved-treatment-for-people-living-with-warm-autoimmune-hemolytic-anemia-waiha-302753581.htmlSOURCE Johnson & Johnson

Original: FDA grants Priority Review for IMAAVY® (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA)

JNJ, buy the dip

Johnson & Johnson to Acquire Atraverse Medical in Cardiac Device ExpansionApril 24, 2026 10:04 AM
IH Market News
Johnson & Johnson (NYSE:JNJ) said on Friday it has agreed to acquire Atraverse Medical, Inc., a privately held medical device company focused on technologies for left-heart access and radiofrequency procedures.



Strengthening Cardiac Ablation Portfolio



Atraverse Medical produces the HOTWIRE Transseptal Access System, an FDA-cleared radiofrequency guidewire and generator platform used to access the left atrium during atrial fibrillation procedures.The system has been deployed in nearly 3,000 clinical cases and includes features such as impedance-sensing automatic energy shutoff, compatibility with a range of sheaths, and enhanced tip visibility under intracardiac echocardiography.



Strategic Rationale



The acquisition is expected to enhance Johnson & Johnson’s cardiac ablation offering, giving electrophysiologists additional tools to treat patients with atrial fibrillation and other heart rhythm disorders.



Deal Timeline



The transaction is anticipated to close in the second quarter of 2026, subject to customary conditions. Financial details of the deal were not disclosed.Johnson & Johnson stock price

Original: Johnson & Johnson to Acquire Atraverse Medical in Cardiac Device Expansion

Johnson & Johnson’s IMAAVY Demonstrates Durable Disease Control in Myasthenia GravisApril 22, 2026 8:49 AM
IH Market News
Johnson & Johnson (NYSE:JNJ) has reported new data from its Phase 3 Vivacity-MG3 trial showing that its therapy IMAAVY (nipocalimab-aahu) sustained disease control in adults with generalized myasthenia gravis over a follow-up period of up to 120 weeks.The study followed 153 patients who tested positive for disease-related antibodies, including anti-AChR and anti-MuSK. At the 96-week mark in the open-label extension phase, patients treated with IMAAVY recorded average improvements of 6.47 points on the MG-ADL scale and 5.97 points on the QMG scale, both key measures of symptom severity and muscle function.Around half of participants achieved minimal symptom expression, with nearly one-third maintaining this level for at least eight weeks. In addition, 57% of patients reduced corticosteroid use to 10 mg per day or less, while total immunoglobulin G levels fell by more than 64%.A post-hoc analysis from the 24-week double-blind phase showed that patients receiving IMAAVY alongside standard treatment were four times more likely to reach sustained minimal symptom expression compared to those given a placebo. Those maintaining this level of disease control also reported greater improvements in quality of life.“These long-term results, now extending to beyond two years, provide further evidence that disease control can be sustained,” said Constantine Farmakidis, Associate Professor of Neurology at the University of Kansas Medical Center.Johnson & Johnson also confirmed that its EPIC trial—comparing IMAAVY with efgartigimod in patients who have not previously received an FcRn blocker—is currently enrolling participants.The company presented the findings as part of seven abstracts at the American Academy of Neurology 2026 Annual Meeting in Chicago. IMAAVY is already approved for treating generalized myasthenia gravis in adults and in patients aged 12 and older who are positive for AChR or MuSK antibodies.Johnson & Johnson stock price

Original: Johnson & Johnson’s IMAAVY Demonstrates Durable Disease Control in Myasthenia Gravis

IMAAVY® (nipocalimab-aahu) shows over two years of sustained disease control in a broad population with generalized myasthenia gravis (gMG)April 22, 2026 8:05 AM
PR Newswire (US)

Through 120 weeks of follow-up, IMAAVY delivered sustained clinical improvements and reductions in total IgG in antibody-positive adult patients including anti-AChR+ and anti-MuSK+Patients achieving sustained minimal symptom expression (MSE) experienced greater improvements in quality of life than those with transient MSE in a post-hoc analysis of the Phase 3 studyEPIC, the first head-to-head study of IMAAVY versus another FcRn blocker in generalized myasthenia gravis, is now enrolling participantsHORSHAM, Pa., April 22, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new data from the Phase 3 Vivacity-MG3 study and ongoing open label extension (OLE) in a broad population of antibody-positive (including anti-AChR+a and anti-MuSK+b) adults with generalized myasthenia gravis (gMG) reinforcing the efficacy, sustained disease control and proven safety profile of IMAAVY® (nipocalimab-aahu). These data are among the seven abstracts Johnson & Johnson is presenting at the American Academy of Neurology (AAN) 2026 Meeting in Chicago, Illinois.







"For people living with gMG, consistent and durable symptom control is the central goal of treatment," said Constantine Farmakidis, MD, Associate Professor of Neurology at the University of Kansas Medical Centerc. "These long-term results, now extending to beyond two years, provide further evidence that disease control, as initially observed in the nipocalimab Phase 3 pivotal study, can be sustained, and add to the body of evidence that may help guide clinical decision-making."Sustained disease control is a key treatment objective in gMG, as long-term maintenance of low disease activity can help prevent exacerbations, reduce treatment burden and support meaningful function outcomes.i In addition, new post-hoc analyses explore the clinical relevance of sustained minimal symptom expression (MSE), an emerging patient-centric treatment goal that reflects minimal day-to-day disease impact for people living with gMG.iiLong-Term Data from OLE PhaseiiiAfter the 24-week double-blind phase of the study, patients entered the ongoing OLE phase, with the latest results reflecting a total of 120 weeks of observation – among the longest follow-up periods reported for any FcRn blocker study in gMG. At 96 weeks in the OLE, IMAAVY demonstrated:Sustained improvements in MG-ADLd and QMGe scores over time, with mean reductions of 6.47f points on the total MG-ADL and 5.97f points on the total QMG scales – measures of MG symptom impact on daily living and muscle strength.Half of patients achieved MSE and nearly one-third (32%) achieved sustained MSE for at least 8 weeks on IMAAVY treatment.Incremental reduction of corticosteroid use was also observed through the OLE, with 57% of patients reaching low doses of ≤10 or ≤5 mg/day.Greater than 64%f reduction in total immunoglobulin G (IgG), including pathogenic IgG autoantibodies, the underlying driver of disease.Minimal Symptom Expression Data from Double-Blind PhaseivA new post-hoc analysis from the 24-week double-blind portion of the study evaluated the impact of sustained MSE on quality of life (based on MG-QoL-15rg measure):Adults who received IMAAVY plus standard of care (SOC)h were four times more likely to reach sustained MSE, defined as achieving an MG-ADL score of 0 or 1 and maintaining it for at least 8 weeks, compared to those randomized to placebo.Patients who reached this level and sustainment of symptom control had the largest gains in day-to-day quality of life, compared with those with improvements that were not similarly sustained, or among those who did not attain MSE."As demonstrated in our pivotal trial, IMAAVY was shown to deliver sustained disease control in a broad population of people living with gMG, helping to address a critical unmet need," said Chris Gasink, MD, Vice President, Medical Affairs, Autoantibody & Gastroenterology, Johnson & Johnson. "These data reinforce our confidence in IMAAVY and our commitment to delivering treatments that can help more people living with gMG achieve meaningful, lasting disease control."Additionally, Johnson & Johnson previously announced plans to initiate EPIC in 2025, the first open-label study designed to compare FcRn blockers in adults with gMG who have never received an FcRn blocker. The study, comparing the efficacy of IMAAVY versus efgartigimod, is now enrolling participants. For a full list of all Johnson & Johnson data being presented at AAN 2026 visit: https://www.jnj.com/innovativemedicine/neuroscience/myasthenia-gravis.Editor's Notes:a.AChR+ = anti-acetylcholine receptor positive antibodyb.MUsK+ = anti-muscle specific tyrosine kinase positive antibodyc.Constantine Farmakidis, MD, has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work.d.MG-ADL (Myasthenia Gravis – Activities of Daily Living) provides a rapid clinical assessment of the patient's recall of symptoms impacting activities of daily living, with a total score range of 0 to 24; a higher score indicates greater symptom severity.ve.QMG (Quantitative Myasthenia Gravis) is a 13-item assessment by a clinician that quantifies MG disease severity. The total QMG score ranges from 0 to 39, where higher scores indicate greater disease severity.vif.Results reflect patients receiving IMAAVY and SOC throughout both the 24-week double-blind phase and OLE phase of the study.g.As measured by MG-QoL-15r (Myasthenia Gravis Quality of Life 15-item Scale – Revised), a scale designed to assess important aspects of the patient's experience related to MG.viih.Standard of care was defined as a stable dose of current gMG treatment, including acetylcholinesterase inhibitors, glucocorticosteroids or immunosupressants (ie, azathioprine, mycophenolate mofetil or mycophenolic acid, methotrexate, ciclosporin, tacrolimus, or cyclophosphamide).viiiABOUT GENERALIZED MYASTHENIA GRAVIS (gMG)
Myasthenia gravis (MG) is an autoantibody disease in which the immune system mistakenly makes antibodies (e.g., anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK]), which target proteins at the neuromuscular junction and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction.ix,x,xi The disease impacts an estimated 700,000 people worldwide.vii The disease affects both men and women and occurs across all ages, racial and ethnic groups, but most frequently starts in young women and older men.xii Roughly 50 percent of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.xiii,xiv,xv Approximately 10 to 15% of new cases of MG are diagnosed in pediatric patients 12-17 years of age.xvi,xvii,xviii Among juvenile MG patients, girls are affected more often than boys with over 65% of pediatric MG cases in the U.S. diagnosed in girls.xix,xx,xxiInitial disease manifestations are usually eye-related but approximately 85% of MG patients experience additional advancements to the disease manifestations, referred to as generalized myasthenia gravis (gMG). This is characterized by severe muscle weakness and difficulties in speech and swallowing.xxii,xxiii,xxiv,xxv,xxvi Approximately 100,000 individuals in the U.S. are living with gMG.xxvii Vulnerable gMG populations, such as pediatric patients, have more limited therapeutic options.xxviiiABOUT THE PHASE 3 VIVACITY-MG3 STUDY
The Phase 3 Vivacity-MG3 study (NCT04951622) was specifically designed to measure sustained efficacy and safety with consistent dosing in this unpredictable chronic condition where unmet need remains high. Antibody positive or negative adult gMG patients with insufficient response (MG-ADL ≥6) to ongoing SOC therapy were identified and 199 patients, 153 of whom were antibody positive, enrolled in the 24-week double-blind placebo-controlled trial.xxix,xxx Randomization was 1:1, nipocalimab plus current SOC (30 mg/kg IV loading dose followed by 15 mg/kg every two weeks) or placebo plus current SOC.xxvii Baseline demographics were balanced across arms (77 nipocalimab, 76 placebo).xxvii The primary efficacy endpoint was the comparison of the mean change from baseline to Weeks 22, 23, and 24 between treatment groups in the MG-ADL total score.xxvii A key secondary endpoint included change in Quantitative Myasthenia Gravis (QMG) score. Long-term safety and efficacy were further assessed in an ongoing open-label extension (OLE) phase.xxviiiABOUT IMAAVY (nipocalimab-aahu)
IMAAVY is an immunoselective treatment designed to target, bind with high affinity, and block FcRn, reducing circulating IgG antibodies that drive disease while also preserving key immune functions. IMAAVY is currently approved for the treatment of gMG in adults and pediatric patients 12 years of age and older who are AChR or MuSK antibody positive.xxxiNipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases, and Maternal Fetal diseases mediated by maternal alloantibodies, in which blockade of IgG binding to FcRn in the placenta is believed to limit transplacental transfer of maternal alloantibodies to the fetus.xxxii,xxxiii,xxxiv,xxxv,xxxvi,xxxvii,xxxviii,xxxix,xlThe U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:  EU EMA Orphan medicinal product designation for HDFN in October 2019 and FNAIT in April 2025U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, fetal and neonatal alloimmune thrombocytopenia (FNAIT) in March 2024, Sjögren's disease (SjD) in March 2025, and systemic lupus erythematosus (SLE) in January 2026U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024  U.S. FDA granted Priority Review in gMG in Q4 2024The legal manufacturer for IMAAVY is Janssen Biotech, Inc.WHAT IS IMAAVY (nipocalimab-aahu)?
IMAAVY is a prescription medicine used to treat adults and children 12 years of age and older with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.It is not known if IMAAVY is safe and effective in children under 12 years of age.IMPORTANT SAFETY INFORMATIONWhat is the most important information I should know about IMAAVY?IMAAVY is a prescription medicine that may cause serious side effects, including:Infections are a common side effect of IMAAVY that can be serious. Receiving IMAAVY may increase your risk of infection. Tell your healthcare provider right away if you have any of the following infection symptoms: feverchillsshiveringcough  sore throatfever blistersburning when you urinate Allergic (hypersensitivity) reactions may happen during or up to a few weeks after your IMAAVY infusion. Get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion: a swollen face, lips, mouth, tongue, or throatdifficulty swallowing or breathing  itchy rash (hives)chest pain or tightness Infusion-related reactions are possible. Tell your healthcare provider right away if you get any of these symptoms during or a few days after your IMAAVY infusion: headacherashnauseafatigue  dizzinesschillsflu-like symptomsredness of skin Do not receive IMAAVY if you have a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY. Reactions have included angioedema and anaphylaxis.Before using IMAAVY, tell your healthcare provider about all of your medical conditions, including if you:ever had an allergic reaction to IMAAVY.have or had any recent infections or symptoms of infection.have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY should not receive live vaccines.are pregnant, plan to become pregnant, or are breastfeeding. It is not known whether IMAAVY will harm your baby.Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY if IMAAVY is given during pregnancy or you become pregnant while receiving IMAAVY. Your healthcare provider should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.What are the possible side effects of IMAAVY?IMAAVY may cause serious side effects. See "What is the most important information I should know about IMAAVY?"The most common side effects of IMAAVY include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.These are not all the possible side effects of IMAAVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.Please see the full Prescribing Information and Medication Guide for IMAAVY and discuss any questions you have with your doctor.Dosage Form and Strengths: IMAAVY is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.cp-509746v1ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com.Follow us at @JNJInnovMed.Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen Global Services, LLC are Johnson & Johnson companies.CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTSThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMAAVY. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.REFERENCESi Narayanaswami P, et al.International Consensus Guidance for Management of Myasthenia Gravis (2020 Update).Neurology. 2021;96:114-122.Affirmed by the American Academy of Neurology Institute Board of Directors (July 14, 2022). [neurology.org]
ii Uzawa, A., Ozawa, Y., Yasuda, M. et al. Minimal symptom expression achievement over time in generalized myasthenia gravis. Acta Neurol Belg 123, 979–982 (2023). https://doi.org/10.1007/s13760-022-02162-1
iii  Antozzi, C et al., Long-term Safety and Efficacy of Nipocalimab: Approximately 2 Years Follow-Up Results from the Open-Label Extension Phase of Vivacity-MG3 Study. Abstract #9.018 for poster presentation at 2026 American Academy of Neurology Congress. April 2026. 
iv Vicente, E et al., Quality of Life in Patients with Generalized Myasthenia Gravis Achieving Sustained vs Transient Minimal Symptom Expression in the Phase 3 Vivacity-MG3 Trial. Abstract #9.007 for poster presentation at 2026 American Academy of Neurology Congress. April 2026. 
v Wolfe GI Myasthenia gravis activities of daily living profile. Neurology. 1999;22;52(7):1487-9. doi: 10.1212/wnl.52.7.1487.
vi Yin J, et al. A multicenter, randomized, open-label, phase 2 clinical study of telitacicept in adult patients with generalized myasthenia gravis. Eur J Neurol. 2024 Aug;31(8):e16322. doi: 10.1111/ene.16322.
vii  Burns TM, Conaway MR, Cutter GR, Sanders DB; Muscle Study Group. Less is more, or almost as much: a 15-item quality-of-life instrument for myasthenia gravis. Muscle Nerve. 2008 Aug;38(2):957-63
viii Antozzi, C et al., Efficacy and safety of nipocalimab in adults with generalised myasthenia gravis (Vivacity MG3): a randomised, double-blind, placebo-controlled phase 3 study. The Lancet Neurology. Feb 2025; 24: 105–16. https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(24)00498-8/fulltext
ix Chen J, Tian D-C, Zhang C, et al. Incidence, mortality, and economic burden of myasthenia gravis in
China: A nationwide population-based study. The Lancet Regional Health - Western Pacific.
https://www.thelancet.com/action/showPdf?pii=S2666-6065%2820%2930063-8
x Bacci ED et al. Understanding side effects of therapy f or myasthenia gravis and their impact on daily life. BMC Neurol. 2019;19(1):335.
xi Wiendl, H., et al., Guideline f or the management of myasthenic syndromes. Therapeutic advances in
neurological disorders, 16, 17562864231213240. https://doi.org/10.1177/17562864231213240 Last
accessed: October 2025.
xii Bubuioc A, et al. The epidemiology of myasthenia gravis. Journal of Medicine & Life (2021). Jan-Mar;14(1):7-16. doi: 10.25122/jml-2020-0145.
xiii Ye, Yun et al. Epidemiology of myasthenia gravis in the United States. Frontiers in neurology vol. 15 1339167. 16 Feb. 2024, doi:10.3389/fneur.2024.1339167.
xiv Dresser, Laura et al. Myasthenia Gravis: Epidemiology, Pathophysiology and Clinical Manifestations. Journal of clinical medicine vol. 10,11 2235. 21 May. 2021, doi:10.3390/jcm10112235.
xv J&J. Data on file.
xvi Evoli A, Batocchi AP, Bartoccioni E, Lino MM, Minisci C, Tonali P. Juvenile myasthenia gravis with prepubertal onset. Neuromuscul Disord. 1998 Dec;8(8):561-7. doi: 10.1016/s0960-8966(98)00077-7.
xvii Evoli A. Acquired myasthenia gravis in childhood. Curr Opin Neurol. 2010 Oct;23(5):536-40. doi: 10.1097/WCO.0b013e32833c32af.
xviii Finnis MF, Jayawant S. Juvenile myasthenia gravis: a paediatric perspective. Autoimmune Dis. 2011;2011:404101. doi: 10.4061/2011/404101.
xix Haliloglu G, Anlar B, Aysun S, Topcu M, Topaloglu H, Turanli G, Yalnizoglu D. Gender prevalence in childhood multiple sclerosis and myasthenia gravis. J Child Neurol. 2002 May;17(5):390-2. doi: 10.1177/088307380201700516.
xx Parr JR, Andrew MJ, Finnis M, Beeson D, Vincent A, Jayawant S. How common is childhood myasthenia? The UK incidence and prevalence of autoimmune and congenital myasthenia. Arch Dis Child. 2014 Jun;99(6):539-42. doi: 10.1136/archdischild-2013-304788.
xxi Mansukhani SA, Bothun ED, Diehl NN, Mohney BG. Incidence and Ocular Features of Pediatric Myasthenias. Am J Ophthalmol. 2019 Apr;200:242-249. doi: 10.1016/j.ajo.2019.01.004.
xxii National Institute of Neurological Disorders and Stroke. Myasthenia Gravis. Available at: https://www.ninds.nih.gov/health-information/disorders/myasthenia-gravis Last accessed: October 2025.
xxiii Bever, C.T., Jr, Aquino, A.V., Penn, A.S., Lovelace, R.E. and Rowland, L.P. (1983), Prognosis of ocular myasthenia. Ann Neurol., 14: 516-519. https://doi.org/10.1002/ana.410140504
xxiv Kupersmith MJ, Latkany R, Homel P. Development of generalized disease at 2 years in patients with ocular myasthenia gravis. Arch Neurol. 2003 Feb;60(2):243-8. doi: 10.1001/archneur.60.2.243. PMID: 12580710.
xxv Myasthenia gravis fact sheet. Retrieved October 2025 from https://www.ninds.nih.gov/sites/default/files/ migrate-documents/myasthenia_gravis_e_march_2020_508c.pdf
xxvi Myasthenia Gravis: Treatment & Symptoms. (2021, April 7). Retrieved October 2025 from https://my.clevelandclinic.org/health/diseases/17252-myasthenia-gravis-mg.
xxvii DRG EPI (2021) & Optum Claims Analysis Jan 2012-December 2020.
xxviii O'Connell K, Ramdas S, Palace J. Management of Juvenile Myasthenia Gravis. Front Neurol. 2020 Jul 24;11:743. doi: 10.3389/fneur.2020.00743. PMID: 32793107; PMCID: PMC7393473.
xxix Antozzi, C et al., Efficacy and safety of nipocalimab in adults with generalised myasthenia gravis (Vivacity MG3): a randomised, double-blind, placebo-controlled phase 3 study. The Lancet Neurology. Feb 2025; 24: 105–16. https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(24)00498-8/fulltext
xxx ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622 Last accessed: October 2025.
xxxi IMAAVY U.S. Prescribing Information.
xxxii ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: October 2025.
xxxiii ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: October 2025.
xxxiv ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050. Last accessed: October 2025.
xxxv ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: October 2025
xxxvi ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: October 2025.
xxxvii ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: October 2025.
xxxviii ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: October 2025.
xxxix ClinicalTrials.gov Identifier: NCT06449651. Available at: https://clinicaltrials.gov/study/NCT06449651. Last accessed: October 2025.
xl ClinicalTrials.gov Identifier: NCT06533098. Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: October 2025.Media contact:Brianna Davis
Bpanase1@its.jnj.com
Investor contact:Jessica Margevich
investor-relations@its.jnj.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/imaavy-nipocalimab-aahu-shows-over-two-years-of-sustained-disease-control-in-a-broad-population-with-generalized-myasthenia-gravis-gmg-302749496.htmlSOURCE Johnson & Johnson

Original: IMAAVY® (nipocalimab-aahu) shows over two years of sustained disease control in a broad population with generalized myasthenia gravis (gMG)

Johnson & Johnson to Participate in the 2026 RBC Capital Markets Global Healthcare ConferenceApril 21, 2026 4:22 PM
Business Wire
Johnson & Johnson (NYSE: JNJ) will participate in the 2026 RBC Capital Markets Global Healthcare Conference on Tuesday, May 19th. Management will participate in a Fireside Chat at 11:30 a.m. Eastern Time.


This live audio webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.


The audio webcast replay will be available approximately 48 hours after the webcast.

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Original: Johnson & Johnson to Participate in the 2026 RBC Capital Markets Global Healthcare Conference

Johnson & Johnson Showcases CARTO-Powered Innovation, Including Debut of CARTOSOUND SONATA, to Advance Arrhythmia Care at HRS 2026April 21, 2026 7:45 AM
Business Wire
As Johnson & Johnson celebrates 30 years of CARTO, the launch of CARTOSOUND SONATA brings new AI-based imaging and mapping capabilitiesi to electrophysiology


A total of 17 abstracts will be presented, including new clinical data for the VARIPULSE Platform


Johnson & Johnson today announced it will showcase the latest advances across its electrophysiology portfolio at the 2026 Heart Rhythm Society (HRS) Annual Meeting, including new evidence in pulsed field ablation (PFA), and innovations in cardiac mapping and imaging.


At HRS 2026, the company will launch the CARTOSOUND SONATA Module, leveraging artificial intelligence with the CARTO System to automatically transform intracardiac echocardiography (ICE) images into detailed maps, allowing physicians to build accurate models of multiple heart chambersi,ii,iii,1. The module also enables identification and automatic labeling of cardiac structuresii,iii.


CARTOSOUND SONATA seamlessly integrates with both SOUNDSTAR CRYSTAL (2D ICE) and NUVISION NAV (4D ICE) ultrasound cathetersiv, enabling physicians to plan and perform treatment across a range of heart rhythm conditions, including atrial fibrillation, ventricular tachycardia, and complex concomitant proceduresii,iii.


“In my experience, CARTOSOUND SONATA elevates imaging capabilities by streamlining the process of building detailed maps of the heart across multiple chambersi using both 2D and 4D ICE technologiesiv,v, even during the most complex concomitant procedures,ii,iii” said Luigi Di Biase2, MD, PhD, FACC, FHRS, System Director Electrophysiology at Montefiore Health System, Professor of Medicine (Cardiology) Albert Einstein College of Medicine at Montefiore Hospital. “This new module continues to demonstrate the power and versatility of the CARTO System and is a clear example of its continued evolution as a key platform in electrophysiology.”


2026 also marks the 30th anniversary of the CARTO System. At HRS, Johnson & Johnson will celebrate how decades of innovation have helped shape modern electrophysiology. From early electroanatomical mapping to today’s integrated AI-powered capabilities, CARTO remains foundational to how electrophysiologists approach arrhythmia care. It serves as a central platform that connects technologies across the electrophysiology portfolio and is designed to evolve alongside clinical practice.


“For 30 years, the CARTO System has led progress in electrophysiology, serving as the foundation of a connected platform that brings together imaging, mapping, and therapy. Looking into the future, we are decisively moving forward with continuous advancements toward new frontiers in cardiac mapping,” said Michael Bodner, Company Group Chair, Electrophysiology & Neurovascular, MedTech, Johnson & Johnson. “As we introduce CARTOSOUND SONATA and continue to progress our PFA technologies, we remain committed to innovation that improves how arrhythmias are understood and treated, while evolving and pushing what’s possible in AFib care.”


At HRS 2026, Johnson & Johnson will present new clinical and real-world data on the VARIPULSE Platform for atrial fibrillation, highlighting safety, workflow efficiency, and real-world patient outcomesvi,vii,viii. Fully integrated with the CARTO System, VARIPULSE delivers precise, efficient, and reproducible treatment outcomesix,x,xi. In the U.S., the latest VARIPULSE Plus update introduces automated irrigation flow control, reinforcing the platform’s safety profile and supporting procedural consistency and physician confidencexii,xiii. Building on this advancement, the company recently launched the VARIPULSE Pro3 platform in Europe with a new pulse sequence to streamline procedures and enhance workflow efficiencyxiv,xv.


Highlights of data being presented at HRS include:


Late-Breaking Presentation: Variable Loop Circular Catheter Pulse Field Ablation in Real-World Practice: Low Complication Rates Across Patient and Procedural Characteristics. LB -525394 -03 Friday, April 24, 10:30am PT. Dr. Christopher Porterfield4


Poster Presentation: The Variable Loop Circular Catheter Safety Survey (VariSure) Early Results. PO -02 -152. Dr. Christopher Porterfield4


Poster Presentation: Zero-exchange Workflow With a Variable Loop PFA Catheter and No Dedicated Mapping Catheter Improves Procedural Efficiency. PO -04 -270. Dr. Mark D. Metzl5


Poster Presentation: Hospital Readmission Among Patients with Paroxysmal Atrial Fibrillation Undergoing Ablation Using a Non-Integrated Pulsed Field Catheter With CARTO™ 3 versus EnSite™ Electroanatomical Mapping System. PO -01-334. Dr. Ronnie Rong6


Poster Presentation: A Prospective Within -Patient Comparison of Transesophageal and Contemporary 4D Intracardiac Echocardiography for Left Atrial Appendage Closure (ICE4 -TEE Study). PO -01-323. Dr. Jiaqi Mi7


At this year’s congress, attendees will have the opportunity to experience interactive, hands-on demonstrations that showcase the power of integration across Johnson & Johnson’s electrophysiology portfolio. In addition, the Rhythm Theater will showcase a panel discussion exploring AI-driven insights with CARTOSOUND SONATA in concomitant and VT procedures. These education opportunities underscore Johnson & Johnson’s commitment to ground innovation in deep scientific expertise. More information can be found here.


Cardiovascular Solutions from Johnson & Johnson MedTech


Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit J&J MedTech electrophysiology.


About Johnson & Johnson


At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn.


Cautions Concerning Forward-Looking Statements


This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to CARTOSOUND SONATA. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.


© Johnson & Johnson and its affiliates 2026. All rights reserved. US_ELP_NAVI_415202


1 as compared to CARTOSOUND FAM Module


2 Dr. Di Biase is a consultant for Johnson & Johnson. Dr. Di Biase was not compensated for this authorship contribution.


3 VARIPULSE Pro is not currently approved in the United States


4 Dr. Porterfield served as a study investigator and as a consultant for Johnson & Johnson. Dr. Porterfield was not compensated for this authorship contribution.


5 Dr. Metzl served as a study investigator and as a consultant for Johnson & Johnson. Dr. Metzl was not compensated for this authorship contribution.


6 Dr. Rong served as a study investigator and as a consultant for Johnson & Johnson. Dr. Rong was not compensated for this authorship contribution.


7 Dr. Mi served as a study investigator and as a consultant for Johnson & Johnson. Dr. Mi was not compensated for this authorship contribution.


i CARTOSOUND SONATA™ Module IFU. UG-5463-0184H, Pg.1. jnjmedtech. 2026


ii CARTOSOUND SONATA™ Module IFU. UG-5463-0184H, Pg.2. jnjmedtech. 2026


iii CARTOSOUND SONATA™ Module IFU. UG-5463-0184H, Pg.3. jnjmedtech. 2026


iv CARTOSOUND SONATA™ Module IFU. UG-5463-0184H, Pg.4. jnjmedtech. 2026


v CARTOSOUND SONATA™ Module IFU. UG-5463-0184H, Pg.8. jnjmedtech. 2026


vi Metzl MD, Wasserlauf J, Joshi N, et al. Zero-exchange workflow with a variable loop PFA catheter and no dedicated mapping catheter improves procedural efficiency. Presented at: Heart Rhythm Society (HRS) 2026; April 23–26, 2026; Chicago, IL.


vii Porterfield CP, Krishnan K, Khaykin Y, et al. Variable loop circular catheter pulsed field ablation in real-world practice: low complication rates across patient and procedural characteristics. Presented at: Heart Rhythm Society (HRS) 2026; April 24, 2026; Chicago, IL.


viii Porterfield CP, Munjal J, Hushion MJ, et al. The variable loop circular catheter real-world safety survey: VARISURE early results. Presented at: Heart Rhythm Society (HRS) 2026; April 23–26, 2026; Chicago, IL.


ix Di Biase L, Marazzato J, Gomez T, et al. Application Repetition and Electrode-Tissue-Contact Results in Deeper Lesions Using a Pulsed-Field Ablation Circular Variable Loop Catheter. Europace. Published online August 16, 2024. Page 3, paragraph 2, Results Section


x Duytschaever M, De Potter T, Grimaldi M, et al. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023 Mar;16(3):e011780. Page 5, Column 1, paragraph 1


xi Reddy VY, Calkins H, Mansour M, et al. Pulsed field ablation to treat paroxysmal atrial fibrillation: safety and effectiveness in the admIRE pivotal trial. Circulation. Published online September 11, 2024. doi: 10.1161/CIRCULATIONAHA.124.070333.Page 5, paragraph 2, Procedural Data Section


xii Almorad A, Sebag FS, Brix Kronborg M, et al. Acute safety, effectiveness and procedural workflow for the pulsed field ablation variable loop circular catheter in AF procedures: a prospective, multicenter, post-market clinical trial. Presented at: European Society of Cardiology (ESC) Congress; September 1, 2025; Madrid, Spain.


xiii Porterfield C, Krishnan K, Saleem M, Steckman D, Ebinger M, Gampa A, et al. Real-world safety profile of a multi-electrode variable loop pulsed-field ablation catheter. Presented at: Kansas City Heart Rhythm Symposium 2025; August 16 2025; Overland Park (Kansas City), KS.


xiv Zito E, Mansour M, Reddy VY, et al. Assessment of temperature dynamics in pulsed field ablation with a variable-loop circular catheter: a comparative analysis of waveform configurations and irrigation rates in specimens of bovine ventricular myocardium. Europace. 2025;27:euaf278. doi:10.1093/europace/euaf278.


xv VARIPULSE Pulse Field Ablations in an in vitro model: temperature characterization of sequence 2 at 30 mL/min vs commercial sequence 1 at 4 mL/min and 30 mL/min. Engineering report. Report No. 502270676.

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Original: Johnson & Johnson Showcases CARTO-Powered Innovation, Including Debut of CARTOSOUND SONATA, to Advance Arrhythmia Care at HRS 2026

Who will $JNJ buy next to support their Spravto brand with more options? $DFTX $ATAI $CMPS - Trump signs order to speed review of psychedelics, including the controversial drug ibogaine

https://apnews.com/article/ibogaine-psychedelic-trump-fda-ptsd-veterans-kennedy-a9940fa57fa1457fc064eb5165003524

Johnson & Johnson Beats Q1 Expectations, Lifts 2026 OutlookApril 14, 2026 8:42 AM
IH Market News
Johnson & Johnson (NYSE:JNJ) reported first-quarter results on Tuesday that came in ahead of analyst forecasts, while also upgrading its full-year 2026 guidance.Adjusted earnings per share were $2.70, exceeding the consensus estimate of $2.68 by $0.02. Revenue totaled $24.1 billion, above expectations of $23.61 billion and up 9.9% from $21.9 billion in the same period last year.The company increased its full-year outlook, now forecasting adjusted EPS in the range of $11.45 to $11.65, with a midpoint of $11.55 in line with analyst expectations. It also expects reported sales between $100.3 billion and $101.3 billion, with a midpoint of $100.8 billion, slightly ahead of the consensus estimate of $100.65 billion. The revised guidance represents an improvement from the company’s January projections. Shares were down 0.2% following the update.“Johnson & Johnson had a strong start to 2026 and is delivering on its promise for a year of accelerated growth and impact,” said Joaquin Duato, Chairman and Chief Executive Officer. “The depth and strength of our portfolio and pipeline is unrivaled and our relentless focus on innovation delivered multiple game-changing approvals this quarter.”The Innovative Medicine division drove performance, with global operational sales rising 7.4%, supported by oncology treatments DARZALEX, CARVYKTI, ERLEADA, and RYBREVANT/LAZCLUZE, as well as TREMFYA in immunology and SPRAVATO in neuroscience. This growth was partly offset by declines in STELARA and IMBRUVICA.Meanwhile, the MedTech segment recorded operational sales growth of 4.6%, led by strong demand for electrophysiology products, Abiomed and Shockwave in cardiovascular, along with trauma-related products in orthopaedics.First-quarter free cash flow came in at approximately $1.5 billion, compared with $3.4 billion in the same period a year earlier.Johnson & Johnson stock price

Original: Johnson & Johnson Beats Q1 Expectations, Lifts 2026 Outlook

Johnson & Johnson Announces 64th Consecutive Year of Dividend Increase; Raises Quarterly Dividend by 3.1%April 14, 2026 6:21 AM
Business Wire
Johnson & Johnson (NYSE: JNJ) today announced that its Board of Directors has declared a 3.1% increase in the quarterly dividend, from $1.30 per share to $1.34 per share, marking the 64th year of consecutive increases.


At the new rate, the indicated dividend on an annual basis is $5.36 per share compared to the previous rate of $5.20 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.


About Johnson & Johnson


At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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Original: Johnson & Johnson Announces 64th Consecutive Year of Dividend Increase; Raises Quarterly Dividend by 3.1%

Johnson & Johnson reports Q1 2026 results, raises 2026 outlookApril 14, 2026 6:20 AM
Business Wire

2026 First-Quarter reported sales growth of 9.9% to $24.1 Billion with operational growth of 6.4%* and adjusted operational growth of 5.3%*



2026 First-Quarter earnings per share (EPS) of $2.14 and adjusted EPS of $2.70



Company increases 2026 guidance with estimated reported sales of $100.8 Billion or 7.0% at the midpoint, and adjusted EPS4 of $11.55 or 7.1% at the midpoint



Solidifying path to double-digit growth by the end of the decade, with significant progress for patients with the approvals of ICOTYDE the first-and-only targeted oral peptide for plaque psoriasis, TECVAYLI plus DARZALEX FASPRO as early as second line for patients with relapsed/refractory multiple myeloma, VARIPULSE Pro in Europe with a new pulse sequence that is now 5 times faster, and TECNIS PureSee Intraocular Lens for U.S. Cataract Patients



Company announces planned Enterprise Business Review for December 8, 2026



Johnson & Johnson (NYSE: JNJ) today announced results for first-quarter 2026. “Johnson & Johnson had a strong start to 2026 and is delivering on its promise for a year of accelerated growth and impact,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “The depth and strength of our portfolio and pipeline is unrivaled and our relentless focus on innovation delivered multiple game-changing approvals this quarter, including ICOTYDE in the U.S. for moderate to severe plaque psoriasis and VARIPULSE Pro in Europe. These advancements have the potential to transform patient outcomes and create sustainable, long-term value for shareholders.”


Overall financial results




 






Q1








($ in Millions, except EPS)






2026






 






2025







% Change








Reported Sales






 






$24,062






 






$21,893







9.9%








Net Earnings






 






$5,235






 






$10,999







-52.4%








EPS (diluted)






 






$2.14






 






$4.54







-52.9%








 






 






 






 








 






Q1








Non-GAAP* ($ in Millions, except EPS)






2026






 






2025







% Change








Operational Sales1,2






 






 






 






 






 






6.4%








Adjusted Operational Sales1,3






 






 






 






 






 






5.3%








Adjusted Net Earnings1,4






 






$6,614






 






$6,706






 






-1.4%








Adjusted EPS (diluted)1,4






 






$2.70






 






$2.77






 






-2.5%








Free Cash Flow5,6






 






~$1,500






 






$3,379






 






 









1






Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules








2






Excludes the impact of translational currency








3






Excludes the net impact of acquisitions and divestitures and translational currency








4






Excludes intangible amortization expense and special items








5






Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings.








6






First-quarter 2026 is estimated as of April 14, 2026








Note: values may have been rounded







Regional sales results




Q1







 







 







 







% Change







 








($ in Millions)







2026







2025







Reported







Operational1,2







Currency







Adjusted




Operational1,3








U.S.







$13,330







$12,305







8.3%







8.3







-







6.2








International







10,732







9,588







11.9







3.9







8.0







4.0








Worldwide







$24,062







$21,893







9.9%







6.4







3.5







5.3









1






Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules








2






Excludes the impact of translational currency








3






Excludes the net impact of acquisitions and divestitures and translational currency








Note: values may have been rounded







Segment sales results




Q1







 







 







 







% Change







 








($ in Millions)







2026







2025







Reported







Operational1,2







Currency







Adjusted




Operational1,3








Innovative Medicine







$15,426







$13,873







11.2%







7.4







3.8







5.6








MedTech







8,636







8,020







7.7







4.6







3.1







4.7








Worldwide







$24,062







$21,893







9.9%







6.4







3.5







5.3









1






Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules








2






Excludes the impact of translational currency








3






Excludes the net impact of acquisitions and divestitures and translational currency








Note: values may have been rounded







First-Quarter 2026 segment commentary:


Operational sales* reflected below excludes the impact of translational currency.


Innovative Medicine


Innovative Medicine worldwide operational sales grew 7.4%*, with net acquisitions and divestitures positively impacting growth by 1.8% primarily due to CAPLYTA. Growth was driven primarily by DARZALEX, CARVYKTI, ERLEADA, and RYBREVANT/LAZCLUZE in Oncology, TREMFYA in Immunology, and SPRAVATO in Neuroscience. Growth was partially offset by an approximate (920) basis points impact from STELARA in Immunology, as well as IMBRUVICA in Oncology.


MedTech


MedTech worldwide operational sales grew 4.6%*, with divestitures negatively impacting growth by 0.1%. Growth was driven primarily by electrophysiology products, Abiomed, and Shockwave in Cardiovascular, as well as trauma in Orthopaedics.


Full-year 2026 guidance:


Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP.




($ in Billions, except EPS)






April 2026






January 2026








Adjusted Operational Sales1,2




Change vs. Prior Year / Mid-point






5.6% – 6.6% / 6.1%






5.4% – 6.4% / 5.9%








Operational Sales2 / Mid-point




Change vs. Prior Year / Mid-point






$99.7B – $100.7B / $100.2B




5.9% – 6.9% / 6.4%






$99.5B – $100.5B / $100.0B




5.7% – 6.7% / 6.2%








Estimated Reported Sales3/ Mid-point




Change vs. Prior Year / Mid-point






$100.3B – $101.3B / $100.8B




6.5% – 7.5% / 7.0%






$100.0B – $101.0B / $100.5B




6.2% – 7.2% / 6.7%








Adjusted Operational EPS (Diluted)2,4 / Mid-point




Change vs. Prior Year / Mid-point






$11.30 – $11.50 / $11.40




4.7% – 6.7% / 5.7%






$11.28 – $11.48 / $11.38




4.5% – 6.5% / 5.5%








Adjusted EPS (Diluted)3,4 / Mid-point




Change vs. Prior Year / Mid-point






$11.45 – $11.65 / $11.55




6.1% – 8.1% / 7.1%






$11.43 – $11.63 / $11.53




5.9% – 7.9% / 6.9%









1






Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures








2






Non-GAAP financial measure; excludes the impact of translational currency








3






Calculated using Euro Average Rate: April 2026 = $1.17 and January 2026 = $1.17 (Illustrative purposes only)








4






Non-GAAP financial measure; excludes intangible amortization expense and special items








Note: percentages may have been rounded







Other modeling considerations will be provided on the webcast.


Notable announcements in the quarter:


The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at Investor News, as well as Innovative Medicine Newsroom, MedTech News & Events, and www.factsabouttalc.com.




Regulatory






Johnson & Johnson Announces FDA Approval of TECNIS PureSee Intraocular Lens, a Breakthrough Solution for U.S. Cataract Patients






Press Release








 






Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI plus DARZALEX FASPRO for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line






Press Release








 






Johnson & Johnson therapy nipocalimab granted U.S. FDA Fast Track designation in systemic lupus erythematosus (SLE)






Press Release








 






Johnson & Johnson seeks FDA approval of IMAAVY (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)






Press Release








 






RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Breakthrough Therapy Designation for patients with advanced head and neck cancer






Press Release








 






FDA approves RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month






Press Release








 






DARZALEX FASPRO-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible






Press Release








Data Releases






Johnson & Johnson Highlights Favorable 12-Month Interim Results for the VARIPULSE Platform at EHRA 20261






Press Release








 






Johnson & Johnson Showcases New Clinical Data for TECNIS PureSee IOL at ASCRS 2026 Demonstrating Excellent Contrast Sensitivity and Extended Range of Vision1






Press Release








 






STEMI DTU Randomized Control Trial Demonstrates for the First Time that a Combination of Delayed Reperfusion and Left Ventricular Unloading Does Not Increase Myocardial Infarct Size






Press Release








 






ICOTYDE (icotrokinra) one-year results confirm lasting skin clearance and favorable safety profile in once-daily pill for plaque psoriasis






Press Release








 






Johnson & Johnson highlights promising first-in-human Erda-iDRS (formerly TAR-210) results in intermediate-risk non-muscle-invasive bladder cancer






Press Release








 






Early study results from Johnson & Johnson show promising antitumor activity with combination of pasritamig and docetaxel in advanced prostate cancer






Press Release








 






TREMFYA (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years






Press Release








 






RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) plus immunotherapy shows strong clinical benefit with 56 percent overall response rate in first-line recurrent or metastatic head and neck cancer






Press Release








 






Johnson & Johnson Presents Early Outcomes from the OMNY-AF Pilot Study at 2026 AF Symposium






Press Release








 






Real-world head-to-head analysis shows 51% reduction in risk of death for patients with metastatic castration-sensitive prostate cancer treated with ERLEADA (apalutamide) versus darolutamide without docetaxel through 24 months






Press Release








Product Launch






Johnson & Johnson Advances Pulsed Field Ablation Portfolio with the Launch of VARIPULSE Pro in Europe1






Press Release








 






FDA approval of ICOTYDE (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide






Press Release








Other






Johnson & Johnson Expands U.S. Footprint with more than $1 Billion Investment in Next Generation Cell Therapy Manufacturing Facility in Pennsylvania






Press Release









1






Subsequent to the quarter







Webcast information:


Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company's website at events-and-presentations.


About Johnson & Johnson:


At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.jnj.com.


Non-GAAP financial measures:


* “Operational sales growth” excluding the impact of translational currency, “adjusted operational sales growth” excluding the net impact of acquisitions and divestitures and translational currency, as well as “adjusted net earnings”, “adjusted diluted earnings per share” and “adjusted operational diluted earnings per share” excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company's website at quarterly results.


Copies of the financial schedules accompanying this earnings release are available on the company’s website at quarterly results. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, an Innovative Medicine pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can also be found in the Investor Relations section of the company's website at quarterly results.


Note to investors concerning forward-looking statements:


This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, and market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations or changes to applicable laws and regulations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; increased scrutiny of the health care industry by government agencies; and the Company's ability to successfully separate the Company's Orthopaedics business and realize the anticipated benefits from the planned separation. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, investor.jnj.com, or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.



Johnson & Johnson and Subsidiaries


Supplementary Sales Data









 










(Unaudited; Dollars in Millions)
FIRST QUARTER







Percent Change



 






2026






 






2025






 






Total






Operations






 






Currency







Sales to customers by






 










segment of business






 

















 










Innovative Medicine






 










U.S.

$






8,871







8,092







9.6






%






9.6







-







International

 






6,555







5,781







13.4






 






4.3







9.1









 






15,426







13,873







11.2






 






7.4







3.8














 










MedTech






 










U.S.

 






4,459







4,213







5.9






 






5.9







-







International

 






4,177







3,807







9.7






 






3.2







6.5









 






8,636







8,020







7.7






 






4.6







3.1














 










U.S.

 






13,330







12,305







8.3






 






8.3







-







International

 






10,732







9,588







11.9






 






3.9







8.0







Worldwide

$






24,062







21,893







9.9






%






6.4







3.5














 










Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely.






Johnson & Johnson and Subsidiaries


Supplementary Sales Data









 










(Unaudited; Dollars in Millions)
FIRST QUARTER







Percent Change



 






2026






 






2025






 






Total






Operations






 






Currency







Sales to customers by






 










geographic area






 

















 










U.S.

$






13,330







12,305







8.3






%






8.3







-














 










Europe

 






5,848







5,110







14.5






 






2.7







11.8







Western Hemisphere excluding U.S.

 






1,293







1,167







10.8






 






2.5







8.3







Asia-Pacific, Africa

 






3,591







3,311







8.5






 






6.1







2.4







International

 






10,732







9,588







11.9






 






3.9







8.0














 










Worldwide

$






24,062







21,893







9.9






%






6.4







3.5














 










Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely.









 












 






REPORTED SALES vs. PRIOR PERIOD ($MM)








 






FIRST QUARTER








 






 






 






 






 







% Change








INNOVATIVE MEDICINE SEGMENT (2)






 






2026






 






2025







Reported







Operational (1)







Currency















 







 







 








ONCOLOGY






 







 







 








US


$






3,615







3,013







20.0%







20.0%







-








Intl


 






3,358







2,664







26.0%







15.3%







10.7%








WW


 






6,973







5,678







22.8%







17.8%







5.0%








DARZALEX






 







 







 








US


 






2,208







1,829







20.7%







20.7%







-








Intl


 






1,756







1,409







24.7%







14.0%







10.7%








WW


 






3,964







3,237







22.5%







17.8%







4.7%








CARVYKTI






 







 







 








US


 






433







318







36.2%







36.2%







-








Intl


 






164







51







*







*







*








WW


 






597







369







62.1%







57.4%







4.7%








TECVAYLI






 







 







 








US


 






127







105







20.6%







20.6%







-








Intl


 






74







46







63.1%







52.1%







11.0%








WW


 






202







151







33.5%







30.1%







3.4%








TALVEY






 







 







 








US


 






101







68







48.5%







48.5%







-








Intl


 






51







18







*







*







*








WW


 






152







86







76.7%







72.8%







3.9%








RYBREVANT / LAZCLUZE






 







 







 








US


 






175







113







55.1%







55.1%







-








Intl


 






82







28







*







*







*








WW


 






257







141







82.7%







80.5%







2.2%








ERLEADA






 







 







 








US


 






342







292







17.3%







17.3%







-








Intl


 






607







479







26.7%







15.5%







11.2%








WW


 






949







771







23.1%







16.2%







6.9%








IMBRUVICA






 







 







 








US


 






143







235







(39.1)%







(39.1)%







-








Intl


 






517







474







9.1%







(1.4)%







10.5%








WW


 






660







709







(6.9)%







(13.9)%







7.0%








OTHER ONCOLOGY (3)






 







 







 








US


 






85







54







58.8%







58.8%







-








Intl


 






106







160







(33.9)%







(36.3)%







2.4%








WW


 






192







214







(10.6)%







(12.5)%







1.9%















 







 







 








See footnotes at end of schedule






 







 







 















 







 







 















 







 







 









 






REPORTED SALES vs. PRIOR PERIOD ($MM)








 






FIRST QUARTER








 






 






 






 






 






 






% Change








 






 






2026






 






2025






 






Reported






 






Operational (1)






 






Currency








IMMUNOLOGY






 







 







 








US


$






1,855







2,196







(15.5)%







(15.5)%







-








Intl


 






1,524







1,510







0.9%







(6.4)%







7.3%








WW


 






3,380







3,707







(8.8)%







(11.8)%







3.0%








TREMFYA






 







 







 








US


 






1,042







599







73.9%







73.9%







-








Intl


 






566







356







58.9%







46.8%







12.1%








WW


 






1,608







956







68.3%







63.8%







4.5%








SIMPONI / SIMPONI ARIA






 







 







 








US


 






269







292







(7.8)%







(7.8)%







-








Intl


 






378







366







3.0%







(4.1)%







7.1%








WW


 






647







659







(1.7)%







(5.7)%







4.0%








REMICADE






 







 







 








US


 






269







314







(14.4)%







(14.4)%







-








US Exports (4)


 






18







10







78.6%







78.6%







-








Intl


 






136







143







(4.8)%







(10.5)%







5.7%








WW


 






422







467







(9.5)%







(11.2)%







1.7%








STELARA






 







 







 








US


 






220







981







(77.6)%







(77.6)%







-








Intl


 






435







644







(32.4)%







(37.7)%







5.3%








WW


 






656







1,625







(59.7)%







(61.7)%







2.0%








OTHER IMMUNOLOGY






 







 







 








US


 






38







1







*







*







-








Intl


 






9







0







*







*







*








WW


 






46







1







*







*







*








NEUROSCIENCE






 







 







 








US


 






1,494







968







54.3%







54.3%







-








Intl


 






681







679







0.3%







(6.3)%







6.6%








WW


 






2,175







1,647







32.0%







29.3%







2.7%








SPRAVATO






 







 







 








US


 






406







276







47.0%







47.0%







-








Intl


 






61







43







42.4%







28.7%







13.7%








WW


 






468







320







46.4%







44.5%







1.9%








CAPLYTA (5)






 







 







 








US


 






270







-







*







*







-








Intl


 






-







-







-







-







-








WW


 






270







-







*







*







-








INVEGA SUSTENNA / XEPLION /
INVEGA TRINZA / TREVICTA






 







 







 








US


 






758







625







21.2%







21.2%







-








Intl


 






280







277







1.1%







(4.9)%







6.0%








WW


 






1,038







903







15.0%







13.2%







1.8%








CONCERTA / Methylphenidate






 







 







 








US


 






22







38







(43.4)%







(43.4)%







-








Intl


 






115







110







4.3%







(0.6)%







4.9%








WW


 






136







148







(8.0)%







(11.7)%







3.7%








OTHER NEUROSCIENCE






 







 







 








US


 






38







28







32.6%







32.6%







-








Intl


 






224







248







(9.7)%







(16.3)%







6.6%








WW


 






262







277







(5.4)%







(11.3)%







5.9%















 







 







 








See footnotes at end of schedule






 







 







 















 







 







 















 







 







 









 






REPORTED SALES vs. PRIOR PERIOD ($MM)








 






FIRST QUARTER








 






 






 






 






 






 






% Change








 






 






2026






 






2025






 






Reported






 






Operational (1)






 






Currency








PULMONARY HYPERTENSION (PH)






 







 







 








US


$






831







744







11.7%







11.7%







-








Intl


 






304







281







8.2%







1.0%







7.2%








WW


 






1,135







1,025







10.7%







8.7%







2.0%








UPTRAVI






 







 







 








US


 






385







365







5.4%







5.4%







-








Intl


 






98







86







14.3%







5.1%







9.2%








WW


 






483







451







7.1%







5.4%







1.7%








OPSUMIT / OPSYNVI






 







 







 








US


 






433







363







19.3%







19.3%







-








Intl


 






172







159







8.7%







1.7%







7.0%








WW


 






606







522







16.1%







14.0%







2.1%








OTHER PULMONARY HYPERTENSION






 







 







 








US


 






12







15







(21.1)%







(21.1)%







-








Intl


 






34







37







(8.3)%







(11.8)%







3.5%








WW


 






46







52







(12.1)%







(14.5)%







2.4%








INFECTIOUS DISEASES (ID)






 







 







 








US


 






342







315







8.6%







8.6%







-








Intl


 






547







487







12.2%







1.3%







10.9%








WW


 






889







802







10.8%







4.1%







6.7%








EDURANT / rilpivirine






 







 







 








US


 






7







8







(13.1)%







(13.1)%







-








Intl


 






402







350







14.8%







3.2%







11.6%








WW


 






409







358







14.1%







2.8%







11.3%








PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA






 







 







 








US


 






334







305







9.5%







9.5%







-








Intl


 






109







98







11.2%







0.7%







10.5%








WW


 






443







403







10.0%







7.4%







2.6%








OTHER INFECTIOUS DISEASES






 







 







 








US


 






1







2







(56.9)%







(56.9)%







-








Intl


 






36







39







(8.3)%







(14.7)%







6.4%








WW


 






37







41







(10.4)%







(16.5)%







6.1%








CARDIOVASCULAR / METABOLISM / OTHER (CVM)






 







 







 








US


 






734







855







(14.2)%







(14.2)%







-








Intl


 






142







158







(10.4)%







(17.5)%







7.1%








WW


 






876







1,013







(13.6)%







(14.7)%







1.1%








XARELTO






 







 







 








US


 






642







690







(7.0)%







(7.0)%







-








Intl


 






-







-







-







-







-








WW


 






642







690







(7.0)%







(7.0)%







-








OTHER






 







 







 








US


 






91







165







(44.5)%







(44.5)%







-








Intl


 






142







158







(10.4)%







(17.5)%







7.1%








WW


 






233







323







(27.8)%







(31.2)%







3.4%








TOTAL PH, ID, CVM






 







 







 








US


 






1,907







1,914







(0.4)%







(0.4)%







-








Intl


 






993







926







7.1%







(2.0)%







9.1%








WW


 






2,899







2,840







2.1%







(0.9)%







3.0%








TOTAL INNOVATIVE MEDICINE






 







 







 








US


 






8,871







8,092







9.6%







9.6%







-








Intl


 






6,555







5,781







13.4%







4.3%







9.1%








WW


$






15,426







13,873







11.2%







7.4%







3.8%















 







 







 








See footnotes at end of schedule






 







 







 















 







 







 















 







 







 









 






REPORTED SALES vs. PRIOR PERIOD ($MM)








 






FIRST QUARTER








 






 






 






 






 






 






% Change







MEDTECH SEGMENT (2)

 






2026






 






2025






 






Reported






 






Operational (1)






 






Currency















 







 







 








CARDIOVASCULAR






 







 







 








US


$






1,399







1,261







10.9%







10.9%







-








Intl


 






978







842







16.1%







9.9%







6.2%








WW


 






2,377







2,103







13.0%







10.5%







2.5%








ELECTROPHYSIOLOGY






 







 







 








US


 






736







684







7.6%







7.6%







-








Intl


 






753







638







18.0%







11.7%







6.3%








WW


 






1,489







1,323







12.6%







9.5%







3.1%








ABIOMED






 







 







 








US


 






389







339







14.5%







14.5%







-








Intl


 






100







81







23.5%







13.9%







9.6%








WW


 






488







420







16.3%







14.4%







1.9%








SHOCKWAVE






 







 







 








US


 






242







206







17.8%







17.8%







-








Intl


 






63







52







21.3%







19.3%







2.0%








WW


 






305







258







18.5%







18.1%







0.4%








OTHER CARDIOVASCULAR






 







 







 








US


 






32







32







0.7%







0.7%







-








Intl


 






62







72







(13.4)%







(17.5)%







4.1%








WW


 






94







103







(9.1)%







(11.9)%







2.8%








SURGERY






 







 







 








US


 






1,046







1,002







4.4%







4.4%







-








Intl


 






1,465







1,394







5.1%







(1.1)%







6.2%








WW


 






2,511







2,396







4.8%







1.2%







3.6%








ADVANCED






 







 







 








US


 






477







457







4.2%







4.2%







-








Intl


 






646







616







4.9%







(1.0)%







5.9%








WW


 






1,123







1,073







4.6%







1.2%







3.4%








GENERAL






 







 







 








US


 






569







544







4.5%







4.5%







-








Intl


 






819







778







5.2%







(1.3)%







6.5%








WW


 






1,388







1,323







4.9%







1.1%







3.8%















 







 







 








See footnotes at end of schedule






 







 







 















 







 







 















 







 







 









 






REPORTED SALES vs. PRIOR PERIOD ($MM)








 






FIRST QUARTER








 






 






 






 






 






 






% Change








 






 






2026






 






2025






 






Reported






 






Operational (1)






 






Currency








VISION






 







 







 








US


$






579







566







2.4%







2.4%







-








Intl


 






785







713







10.1%







4.6%







5.5%








WW


 






1,365







1,279







6.7%







3.6%







3.1%








CONTACT LENSES / OTHER






 







 







 








US


 






468







452







3.7%







3.7%







-








Intl


 






501







467







7.2%







1.7%







5.5%








WW


 






969







919







5.5%







2.7%







2.8%








SURGICAL






 







 







 








US


 






111







114







(2.9)%







(2.9)%







-








Intl


 






285







246







15.6%







10.1%







5.5%








WW


 






396







361







9.7%







6.0%







3.7%








ORTHOPAEDICS






 







 







 








US


 






1,435







1,384







3.7%







3.7%







-








Intl


 






948







857







10.6%







2.4%







8.2%








WW


 






2,383







2,241







6.3%







3.2%







3.1%








HIPS






 







 







 








US


 






277







263







5.2%







5.2%







-








Intl


 






159







146







8.9%







0.3%







8.6%








WW


 






436







409







6.5%







3.5%







3.0%








KNEES






 







 







 








US


 






239







231







3.3%







3.3%







-








Intl


 






181







158







14.6%







6.5%







8.1%








WW


 






420







389







7.9%







4.6%







3.3%








TRAUMA






 







 







 








US


 






532







502







6.1%







6.1%







-








Intl


 






301







270







11.4%







3.1%







8.3%








WW


 






833







772







8.0%







5.0%







3.0%








SPINE, SPORTS & OTHER






 







 







 








US


 






387







388







(0.1)%







(0.1)%







-








Intl


 






307







283







8.4%







0.7%







7.7%








WW


 






694







671







3.5%







0.2%







3.3%








TOTAL MEDTECH






 







 







 








US


 






4,459







4,213







5.9%







5.9%







-








Intl


 






4,177







3,807







9.7%







3.2%







6.5%








WW


$






8,636







8,020







7.7%







4.6%







3.1%















 







 







 









Note: Columns and rows within tables may not add due to rounding. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely


 


* Percentage greater than 100% or not meaningful


(1) Operational growth excludes the effect of translational currency


(2) Unaudited


(3) Includes the sales of ZYTIGA which were previously disclosed separately


(4) Reported as U.S. sales


(5) Acquired with Intra-Cellular Therapies on April 2, 2025



Johnson & Johnson and Subsidiaries


Condensed Consolidated Statement of Earnings











 


(Unaudited; in Millions Except Per Share Figures)
FIRST QUARTER











 




2026







2025







 











Percent




to Sales









Percent




to Sales







Percent




Increase




(Decrease)









Amount








Amount









Sales to customers

$






24,062







100.0







$






21,893






 







100.0






 







9.9






 







Cost of products sold

 






8,106







33.7







 






7,357






 







33.6






 







10.2






 







Gross Profit

 






15,956







66.3







 






14,536






 







66.4






 







9.8






 







Selling, marketing and administrative expenses

 






6,034







25.1







 






5,112






 







23.3






 







18.0






 







Research and development expense

 






3,527







14.7







 






3,225






 







14.7






 







9.4






 







In-process research and development impairments

 






36







0.1







 






-






 







-






 









Interest (income) expense, net

 






43







0.2







 






(128






)







(0.6






)









Other (income) expense, net

 






294







1.2







 






(7,321






)







(33.4






)









Restructuring

 






32







0.1







 






17






 







0.1






 









Earnings before provision for taxes on income

 






5,990







24.9







 






13,631






 







62.3






 







(56.1






)







Provision for taxes on income

 






755







3.1







 






2,632






 







12.1






 







(71.3






)







Net earnings

$






5,235







21.8







$






10,999






 







50.2






 







(52.4






)
















 


Net earnings per share (Diluted)

$






2.14









$






4.54






 









(52.9






)
















 


Average shares outstanding (Diluted)

 






2,445.2









 






2,423.8






 




















 


Effective tax rate

 






12.6






%








 






19.3






 






%



















 


Adjusted earnings before provision for taxes and net earnings (1)











Earnings before provision for taxes on income

$






7,821







32.5







$






8,011






 







36.6






 







(2.4






)







Net earnings

$






6,614







27.5







$






6,706






 







30.6






 







(1.4






)







Net earnings per share (Diluted)

$






2.70









$






2.77






 









(2.5






)







Effective tax rate

 






15.4






%








 






16.3






 






%



















 


(1) See Reconciliation of Non-GAAP Financial Measures.







Johnson & Johnson and Subsidiaries








Reconciliation of Non-GAAP Financial Measure










 







 







 








Adjusted Operational Sales Growth








FIRST QUARTER 2026 ACTUAL vs. 2025 ACTUAL








 








Segments










 







 







 










Innovative Medicine







MedTech







Total










 







 







 







WW As Reported


11.2%







7.7%







9.9%







U.S.


9.6%







5.9%







8.3%







International


13.4%







9.7%







11.9%










 







 







 







WW Currency


3.8







3.1







3.5







U.S.


-







-







-







International


9.1







6.5







8.0










 







 







 







WW Operational


7.4%







4.6%







6.4%







U.S.


9.6%







5.9%







8.3%







International


4.3%







3.2%







3.9%










 







 







 







Caplyta


(1.9)







 







(1.2)







U.S.


(3.3)







 







(2.2)







International


0.0







 







0.0










 







 







 







All Other Acquisitions and Divestitures (A&D)


0.1







0.1







0.1







U.S.


0.0







0.2







0.1







International


0.2







0.0







0.1










 







 







 







WW Adjusted Operational Ex A&D


5.6%







4.7%







5.3%







U.S.


6.3%







6.1%







6.2%







International


4.5%







3.2%







4.0%










 







 







 










 







 







 








Note: Percentages are based on actual, non-rounded figures and may not sum








Johnson & Johnson and Subsidiaries


Reconciliation of Non-GAAP Financial Measures







 





First Quarter



(Dollars in Millions Except Per Share Data)


2026






 







2025






 








Net Earnings, after tax- as reported


$5,235






 







$10,999






 












 



Pre-tax Adjustments







Intangible Asset Amortization expense


1,247






 







1,120






 








Litigation related


330






 







(6,966






)








Orthopaedics Separation related


119






 







-






 








Acquisition, integration and divestiture related


96






 







132






 








Restructuring related 1


62






 







55






 








IPR&D impairments


36






 







-






 








(Gains)/losses on securities


(59






)







39






 












 



Tax Adjustments







Tax impact on special item adjustments 2


(424






)







1,315






 








Tax legislation and other tax related


(28






)







12






 








Adjusted Net Earnings, after tax


$6,614






 







$6,706






 








Average shares outstanding (Diluted)


2,445.2






 







2,423.8






 








Adjusted net earnings per share (Diluted)


$2.70






 







$2.77






 








Operational adjusted net earnings per share (Diluted)


$2.57






 














 



Notes:







1





In fiscal 2023, the company initiated a restructuring program of its Orthopaedics franchise within the MedTech segment to streamline operations by exiting certain markets, product lines and distribution network arrangements. The restructuring expense of $7 million in the fiscal first quarter of 2026 and $55 million in the fiscal first quarter of 2025 primarily includes costs related to market and product exits. This program was substantially completed in Q4 2025.



 



In fiscal 2025, the company initiated a restructuring program of its Surgery franchise within the MedTech segment to simplify and focus operations by exiting certain non-strategic product lines and optimize select sites across the network. The restructuring expense of $55 million in the fiscal first quarter of 2026 primarily includes costs related to product exits. This program is expected to be substantially completed by the end of fiscal year 2026.







 



2





The tax impact related to special item adjustments reflects the current and deferred income taxes associated with the above pre-tax special items in arriving at adjusted earnings.



 



Johnson & Johnson and Subsidiaries


GAAP to Non-GAAP Reconciliation


$ in Millions


Year to Date





















Innovative Medicine
First Quarter
Mar. 29, 2026
GAAP

Intangible asset amortization

Litigation related

In-process research and development impairments

Restructuring related

Acquisition, integration and divestiture related

(Loss)/gain on securities

Orthopaedics Separation Related

Tax legislation and other tax related

First Quarter
Mar. 29, 2026
Non-GAAP


Cost of products sold

$






4,390






 







(763






)













(10






)













$






3,617






 







Selling, marketing and admin expenses

 






2,918






 























 






2,918






 







Research and development expense

 






2,813






 























 






2,813






 







Other segment items

 






(12






)









(40






)











(46






)







55






 











 






(43






)







Adjusted Income Before Tax by Segment

 






5,317






 







763






 







40






 







-






 







-






 







56






 







(55






)







-






 







-






 







 






6,121






 


























 


MedTech
First Quarter
Mar. 29, 2026
GAAP

Intangible asset amortization

Litigation related

In-process research and development impairments

Restructuring related

Acquisition, integration and divestiture related

(Loss)/gain on securities

Orthopaedics Separation Related

Tax legislation and other tax related

First Quarter
Mar. 29, 2026
Non-GAAP


Cost of products sold

$






3,701






 







(484






)











(25






)















$






3,192






 







Selling, marketing and admin expenses

 






2,906






 























 






2,906






 







Research and development expense

 






714






 























 






714






 







Other segment items

 






76






 









41






 







(36






)







(37






)







(27






)







4






 







(119






)









 






(98






)







Adjusted Income Before Tax by Segment

 






1,239






 







484






 







(41






)







36






 







62






 







27






 







(4






)







119






 







-






 







 






1,922






 


























 


Expenses not allocated to segments
First Quarter
Mar. 29, 2026
GAAP

Intangible asset amortization

Litigation related

In-process research and development impairments

Restructuring related

Acquisition, integration and divestiture related

(Loss)/gain on securities

Orthopaedics Separation Related

Tax legislation and other tax related

First Quarter
Mar. 29, 2026
Non-GAAP


Cost of products sold

$






15






 























$






15






 







Selling, marketing and admin expenses

 






210






 























 






210






 







Research and development expense

 






-






 























 






-






 







Other segment items

 






341






 









(331






)











(13






)













 






(3






)







Adjusted Income Before Tax by Segment

 






(566






)







-






 







331






 







-






 







-






 







13






 







-






 







-






 







-






 







 






(222






)


























 


Johnson & Johnson Consolidated
First Quarter
Mar. 29, 2026
GAAP

Intangible asset amortization

Litigation related

In-process research and development impairments

Restructuring related

Acquisition, integration and divestiture related

(Loss)/gain on securities

Orthopaedics Separation Related

Tax legislation and other tax related

First Quarter
Mar. 29, 2026
Non-GAAP


Cost of products sold

$






8,106






 







(1,247






)











(25






)







(10






)













$






6,824






 







Selling, marketing and admin expenses

 






6,034






 























 






6,034






 







Research and development expense

 






3,527






 























 






3,527






 







Other (Income) / Expense

 






294






 









(330






)









(5






)







(86






)







59






 







(119






)









 






(187






)







In-process research and development impairments

 






36






 











(36






)

















 






-






 







Interest (Income)/Expense

 






43






 























 






43






 







Restructuring

 






32






 













(32






)















 






-






 







Adjusted Income Before Tax

 






5,990






 







1,247






 







330






 







36






 







62






 







96






 







(59






)







119






 







-






 







 






7,821






 







Provision for taxes on income

 






755






 







240






 







72






 







8






 







70






 







22






 







(13






)







25






 







28






 







 






1,207






 







Net Earnings

$






5,235






 







1,007






 







258






 







28






 







(8






)







74






 







(46






)







94






 







(28






)







 






6,614






 








Johnson & Johnson and Subsidiaries


GAAP to Non-GAAP Reconciliation


$ in Millions


Year to Date


Innovative Medicine
First Quarter March 30, 2025
GAAP

Intangible asset amortization

Litigation related

Restructuring related

Acquisition, integration and divestiture related

(Loss)/gain on securities

Tax legislation and other tax related

First Quarter March 30, 2025
Non-GAAP


Cost of products sold

$






4,020






 







(649






)

















3,371






 







Selling, marketing and admin expenses

 






2,261






 



















2,261






 







Research and development expense

 






2,548






 



















2,548






 







Other segment items

 






(166






)







-






 







-






 







-






 







(20






)







(18






)







-






 







(204






)







Adjusted Income Before Tax by Segment

 






5,210






 







649






 







-






 







-






 







20






 







18






 







-






 







5,897






 






















 


MedTech
First Quarter March 30, 2025
GAAP

Intangible asset amortization

Litigation related

Restructuring related

Acquisition, integration and divestiture related

(Loss)/gain on securities

Tax legislation and other tax related

First Quarter March 30, 2025
Non-GAAP


Cost of products sold

$






3,326






 







(471






)









(8






)







(52






)











2,795






 







Selling, marketing and admin expenses

 






2,656






 



















2,656






 







Research and development expense

 






677






 













(6






)











671






 







Other segment items

 






(60






)







-






 







-






 







(47






)







(54






)







(21






)







-






 







(182






)







Adjusted Income Before Tax by Segment

 






1,421






 







471






 







-






 







55






 







112






 







21






 







-






 







2,080






 






















 


Expenses not allocated to segments
First Quarter March 30, 2025
GAAP

Intangible asset amortization

Litigation related

Restructuring related

Acquisition, integration and divestiture related

(Loss)/gain on securities

Tax legislation and other tax related

First Quarter March 30, 2025
Non-GAAP


Cost of products sold

$






11






 



















11






 







Selling, marketing and admin expenses

 






195






 



















195






 







Research and development expense















-






 







Other segment items

 






(7,206






)







-






 







6,966






 







-






 







-






 







-






 







-






 







(240






)







Adjusted Income Before Tax by Segment

 






7,000






 







-






 







(6,966






)







-






 







-






 







-






 







-






 







34






 






















 


Johnson & Johnson Consolidated
First Quarter March 30, 2025
GAAP

Intangible asset amortization

Litigation related

Restructuring related

Acquisition, integration and divestiture related

(Loss)/gain on securities

Tax legislation and other tax related

First Quarter March 30, 2025
Non-GAAP


Cost of products sold

$






7,357






 







(1,120






)









(8






)







(52






)









-






 







6,177






 







Selling, marketing and admin expenses

 






5,112






 



















5,112






 







Research and development expense

 






3,225






 













(6






)











3,219






 







Other (Income) / Expense

 






(7,321






)







-






 







6,966






 







(30






)







(74






)







(39






)









(498






)







In-process research and development impairments

 






-






 



















-






 







Interest (Income)/Expense

 






(128






)



















(128






)







Restructuring

 






17






 











(17






)













-






 







Adjusted Income Before Tax

 






13,631






 







1,120






 







(6,966






)







55






 







132






 







39






 







-






 







8,011






 







Provision for taxes on income

 






2,632






 







188






 







(1,553






)







11






 







30






 







9






 







(12






)







1,305






 







Net Earnings

 






10,999






 







932






 







(5,413






)







44






 







102






 







30






 







12






 







6,706






 







 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260414061421/en/
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Original: Johnson & Johnson reports Q1 2026 results, raises 2026 outlook