RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Special Review Project (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC25H24N6O2

InChIKeyXYFPWWZEPKGCCK-GOSISDBHSA-N

CAS Registry936563-96-1

401

Clinical Trials associated with Ibrutinib

NCT06649812

/ RecruitingPhase 2IIT

A Phase 2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse-Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2)

This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid? (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.

Start Date21 Mar 2026

Sponsor / Collaborator

National Cancer Institute

NCT07052695

/ Not yet recruitingPhase 1/2IIT

A Pilot Study Evaluating Mosunetuzumab for Clearance of Detectable Minimal Residual Disease in Chronic Lymphocytic Leukemia

The goal of this study is to test mosunetuzumab given alone or in combination with a Bruton tyrosine kinase inhibitor (BTKi, such as ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib) in participants with CLL (chronic lymphocytic leukemia) or small lymphocytic lymphoma (SLL).
The names of the study drugs in this research study are:
* Mosunetuzumab
* BTK inhibitor: Ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib

Start Date01 Aug 2025

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06958705

/ RecruitingPhase 2IIT

Study of the Efficacy and Safety of Venetoclax as Consolidation to Achieve Fix-Duration Treatment in CLL Patients Treated With BTK Inhibitor Monotherapy

This is an open-label, multicenter, phase 2, non-randomized study aiming to study the efficacy and safety of fixed-duration venetoclax consolidation in CLL patients who are on BTK inhibitor monotherapy. Patients who are on BTK inhibitor monotherapy for ≥ 6 months and still responsive are included. The study includes patients who are treatment-naive before taking BTK inhibitors. Patients will be treated with the BTK inhibitor plus full-dose venetoclax for 12 cycles after a standard 5-week dose ramp-up. Peripheral blood and bone marrow MRD status will be evaluated during and after the treatment. After the completion of combination therapy, patients will stop both BTK inhibitor and venetoclax and be followed.

Start Date01 Jun 2025

Sponsor / Collaborator

Third Affiliated Hospital of Nanjing Medical University

[+1]

100 Clinical Results associated with Ibrutinib

100 Translational Medicine associated with Ibrutinib

100 Patents (Medical) associated with Ibrutinib

5,461

Literatures (Medical) associated with Ibrutinib

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Evaluation of Bruton’s Tyrosine Kinase (BTK) inhibition with alternative doses of ibrutinib in subjects with Chronic Lymphocytic Leukemia (CLL)

Article

Author: Smith, Emma ; Valenzuela, Belén ; Desphande, Sanjay ; Haddish-Berhane, Nahor ; Perez Ruixo, Juan José ; Srinivasan, Srimathi ; Treijtel, Nicoline ; Ouerdani, Aziz

Abstract:

Purpose:

To evaluate alternative ibrutinib dosing regimens that maintain Bruton’s tyrosine kinase (BTK) receptor occupancy over the entire dosing interval for CLL patients using a model-based approach.

Methods:

Ibrutinib inhibits B-cell proliferation via irreversible binding of BTK. As IC50 is not an appropriate parameter to describe the potency of the inhibition in the presence of a covalent binding inhibitor. A BTK covalent binding model was developed using kinact/KI as key parameter to account for covalent binding. The ibrutinib-BTK covalent binding model was used to describe the effect of daily doses of 140, 280, 420 and 560 mg on the proportion of subjects with more than 90% BTK inhibition at steady state trough concentrations. Predictive performance of the model was assessed using the available ibrutinib BTK inhibition data following QD dosing. Model-based predictions were used to identify the minimum ibrutinib QD dose that provides more than 90% inhibition in more than 90% of the subjects.

Results:

The covalent binding model was able to describe the data and predicted that ibrutinib QD dose reduced from 420 mg to 280 mg or 140 mg may inhibit de novo synthetized BTK efficiently in a CLL population.

Conclusion:

Using a model-based approach showed that reducing the ibrutinib dosing regimen to 280 mg QD or even 140 mg in case of adverse events could maintain BTK inhibition over the entire dosing interval.

01 Dec 2025·Blood Research

Relative efficacy of systemic treatments for patients with relapsed/refractory chronic lymphocytic leukemia: a network meta-analysis according to 17p deletion/TP53 mutations

Article

Author: Lim, Joo Han ; Kim, Jinchul ; Lee, Moon Hee ; Cho, Jinhyun

Abstract:

Purpose:

This network meta-analysis aimed to evaluate the relative efficacy of systemic treatments in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), focusing on key genetic mutations, specifically the 17p deletion and TP53 mutations.

Methods:

We conducted a systematic literature review to identify all publicly available randomized controlled trials (RCTs) using PubMed, EMBASE, the Cochrane database, and meeting abstracts published through December 2023. A Bayesian network meta-analysis was performed to estimate the hazard ratios (HRs) for progression-free survival (PFS) with 95% confidence intervals (CIs) and to determine the ranking of the included regimens.

Results:

Twelve trials involving 4,437 patients and 13 treatment options were included in the meta-analysis. Venetoclax plus rituximab and zanubrutinib emerged as the most effective treatments for the overall R/R CLL population, showing the lowest PFS HR (HR 0.62, 95% CI 0.32–1.20 and HR 0.65, 95% CI 0.49–0.86, respectively) versus ibrutinib, and were ranked as the best agent (surface under the cumulative ranking curve [SUCRA] value of both 90%, respectively) among the included drugs. In the 17p deletion/TP53 mutation subgroup, zanubrutinib demonstrated the most favorable efficacy (HR 0.52, 95% CI 0.31–0.88 versus ibrutinib) with the highest SUCRA value (97%). In patients without these mutations, venetoclax plus rituximab was the most effective (HR 0.49, 95% CI 0.26–0.94 versus ibrutinib) with a SUCRA value of 94%.

Conclusion:

Our findings highlight the superior efficacy of venetoclax plus rituximab and zanubrutinib for treating R/R CLL and confirm that the role of each regimen may vary depending on the clinically significant mutations.

01 Dec 2025·JOURNAL OF CLINICAL IMMUNOLOGY

Disseminated Aspergillosis in X-linked Agammaglobulinemia: Beyond the norm

Letter

Author: Rawat, Amit ; Vignesh, Pandiarajan ; Jindal, Ankur Kumar ; Thangaraj, Abarna ; Goel, Sumit ; Sil, Archan

X-linked agammaglobulinemia (XLA) due to a mutation in Bruton's tyrosine kinase (BTK), leads to the arrested development of B cells at the pro-B cell stage. This results in absent B cells and severe hypogammaglobulinemia. XLA patients usually present with recurrent sinopulmonary infection. Bacterial infections are the commonest [2], fungal infections like Pneumocystis jirovecii, Aspergillus and Candida species are rarely reported and they are associated with mortality in XLA [3]. We report a 3.5-year-old boy with disseminated aspergillosis, an uncommon presentation of XLA. Despite treatment with antifungals, including voriconazole and amphotericin B, the patient succumbed to the illness. Genetic analysis revealed a pathogenic variant in the BTK gene (R28H), confirming XLA diagnosis. This case highlights the potential for severe fungal infections in XLA patients and suggests broader immune system dysregulation beyond B-cell defects.

706

News (Medical) associated with Ibrutinib

16 Jul 2025

·www.investor.jnj.com

Johnson & Johnson Reports Q2 2025 Results; Raises 2025 Outlook

2025 Second-Quarter reported sales growth of 5.8% to $23.7 Billion with operational growth of 4.6%* and adjusted operational growth of 3.0%* 2025 Second-Quarter reflects earnings per share (EPS) of $2.29 and adjusted EPS of $2.77 Significant new product pipeline progress including approval of IMAAVY for generalized myasthenia gravis, priority review for TAR-200, data for CARVYKTI overall survival and progression-free benefits in multiple myeloma, and continuation of the clinical trial for a general surgery robotic system, OTTAVA Strong operational performance and favorable foreign exchange results in Company increasing full year estimated reported sales5 guidance at the midpoint by $2 billion dollars to 5.4% and full year EPS guidance by $0.25 to $10.85. Adjusted operational EPS increased to $10.68 at the midpoint. NEW BRUNSWICK, N.J.--(BUSINESS WIRE)-- Johnson & Johnson (NYSE: JNJ) today announced results for second-quarter 2025. “Today’s strong results reflect the depth and strength of Johnson & Johnson’s uniquely diversified business operating across both MedTech and Innovative Medicine,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “Our portfolio and pipeline position us for elevated growth in the second half of the year, with game-changing approvals and submissions anticipated in areas like lung and bladder cancer, major depressive disorder, psoriasis, surgery and cardiovascular, which will extend and improve lives in transformative ways.” Overall financial results Q2 ($ in Millions, except EPS) 2025 2024 % Change Reported Sales $23,743 $22,447 5.8% Net Earnings $5,537 $4,686 18.2% EPS (diluted) $2.29 $1.93 18.7% Q2 Non-GAAP* ($ in Millions, except EPS) 2025 2024 % Change Operational Sales1,2 4.6% Adjusted Operational Sales1,3 3.0% Adjusted Net Earnings1,4 $6,699 $6,840 -2.1% Adjusted EPS (diluted)1,4 $2.77 $2.82 -1.8% Free Cash Flow6,7 ~$6,200 $7,507 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine 6 Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 7 Second-quarter YTD 2025 is estimated as of July 16, 2025 Regional sales results Q2 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 U.S. $13,544 $12,569 7.8% 7.8 - 5.0 International 10,199 9,878 3.2 0.6 2.6 0.4 Worldwide $23,743 $22,447 5.8% 4.6 1.2 3.0 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Segment sales results Q2 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 Innovative Medicine $15,202 $14,490 4.9% 3.8 1.1 2.4 MedTech 8,541 7,957 7.3 6.1 1.2 4.1 Worldwide $23,743 $22,447 5.8% 4.6 1.2 3.0 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Second-Quarter 2025 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales grew 3.8%*, with net acquisitions and divestitures positively impacting growth by 1.4%. Growth was primarily driven by DARZALEX, CARVYKTI, ERLEADA and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, and SPRAVATO in Neuroscience. Growth was partially offset by an approximate (1,170) basis points impact from STELARA in Immunology, and an approximate (130) basis points impact from COVID-19 in Infectious Diseases. MedTech MedTech worldwide operational sales grew 6.1%*, with net acquisitions and divestitures positively impacting growth by 2.0%. Growth was primarily driven by electrophysiology products and Abiomed in Cardiovascular, as well as wound closure products in General Surgery. Full-year 2025 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) July 2025 April 2025 Adjusted Operational Sales1,2,5 Change vs. Prior Year / Mid-point 3.2% – 3.7% / 3.5% 2.0% – 3.0% / 2.5% Operational Sales2,5 / Mid-point Change vs. Prior Year / Mid-point $92.7B – $93.1B / $92.9B 4.5% – 5.0% / 4.8% $91.6B – $92.4B / $92.0B 3.3% – 4.3% / 3.8% Estimated Reported Sales3,5/ Mid-point Change vs. Prior Year / Mid-point $93.2B – $93.6B / $93.4B 5.1% – 5.6% / 5.4% $91.0B – $91.8B / $91.4B 2.6% – 3.6% / 3.1% Adjusted Operational EPS (Diluted)2,4 / Mid-point Change vs. Prior Year / Mid-point $10.63 – $10.73 / $10.68 6.5% – 7.5% / 7.0% $10.50 – $10.70 / $10.60 5.2% – 7.2% / 6.2% Adjusted EPS (Diluted)3,4 / Mid-point Change vs. Prior Year / Mid-point $10.80 – $10.90 / $10.85 8.2% – 9.2% / 8.7% $10.50 – $10.70 / $10.60 5.2% – 7.2% / 6.2% 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: July 2025 = $1.13 and April 2025 = $1.10 (Illustrative purposes only) 4 Non-GAAP financial measure; excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine 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 News Releases, as well as Innovative Medicine News Center, MedTech News & Events, and www.factsabouttalc.com. Regulatory Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo1 Press Release DARZALEX® (daratumumab) receives the first positive CHMP opinion for patients with high-risk smouldering multiple myeloma Press Release IMBRUVICA® (ibrutinib) receives positive CHMP opinion for the treatment of patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplant Press Release U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma Press Release Johnson & Johnson receives FDA approval for IMAAVY™ (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG) Press Release Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA™ Robotic Surgical System Press Release Data Releases IMAAVY™ (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC) Press Release Investigational combination of first-in-class bispecifics TALVEY® and TECVAYLI® shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease Press Release Johnson & Johnson's dual-targeting CAR T-cell therapy shows encouraging first results in large B-cell lymphoma Press Release New results for Johnson & Johnson's bleximenib demonstrate promising antileukemic activity in combination with venetoclax and azacitidine for acute myeloid leukemia Press Release Significant efficacy benefit of IMBRUVICA® (ibrutinib) plus venetoclax versus acalabrutinib plus venetoclax in frontline treatment of patients with chronic lymphocytic leukaemia suggested by indirect treatment comparison Press Release New data show TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis Press Release DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant-eligible, newly diagnosed patients with multiple myeloma who achieved sustained MRD negativity Press Release Early results from Johnson & Johnson's trispecific antibody show promising response in heavily pretreated multiple myeloma patients Press Release Single infusion of CARVYKTI® (ciltacabtagene autoleucel) delivered lasting treatment-free remissions for at least five years in patients with relapsed or refractory multiple myeloma Press Release Johnson & Johnson leads with first PARP inhibitor combo to improve efficacy in patients with HRR-altered mCSPC Press Release Johnson & Johnson unveils first-in-human results for pasritamig, showing early anti-tumor activity in prostate cancer Press Release Shockwave Medical Study Confirms Benefit of IVL-First Strategy in Real-World Female Patients with Complex Calcified Lesions in Late-Breaking Data Presentation at EuroPCR 2025 Press Release Icotrokinra results show significant skin clearance in patients with difficult-to-treat scalp and genital psoriasis Press Release TREMFYA® (guselkumab) delivers sustained clinical and endoscopic remission in ulcerative colitis through two years Press Release TREMFYA® (guselkumab) positioned to become the first and only IL-23 inhibitor to offer subcutaneous induction in ulcerative colitis as demonstrated in new data through 24 weeks Press Release Johnson & Johnson's TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC Press Release Johnson & Johnson's TAR-200 monotherapy demonstrates highest complete response rate with sustained clinical benefits in patients with certain types of bladder cancer Press Release Johnson & Johnson MedTech Presents 3-Month Data from Omny-IRE Clinical Trial at 2025 Heart Rhythm Society Annual Meeting Press Release Product Launch Johnson & Johnson Launches First and Only Daily Disposable Multifocal Toric Contact Lens - ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM Press Release Johnson & Johnson Launches VOLT™ Wrist and Proximal Humerus Plating Systems in the U.S. Press Release Johnson & Johnson Launches New TECNIS Odyssey Next-Generation Intraocular Lens in Europe, the Middle East, and Canada Offering Cataract Patients Precise Vision at Every Distance in Any Lighting Press Release Johnson & Johnson Launches KINCISE™ 2 System, the Only Automated Surgical Impactor Approved for Knee and Hip Revision Procedures Press Release Johnson & Johnson MedTech Launches SOUNDSTAR CRYSTAL™ in the US, Redefining Image Clarity in 2D Intracardiac Imaging Press Release Other Johnson & Johnson Elects Daniel Pinto, President, JPMorganChase to its Board of Directors 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; and increased scrutiny of the health care industry by government agencies. 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. Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency $ 9,161 8,510 7.6 % 7.6 - $ 17,253 16,122 7.0 % 7.0 - 6,041 5,980 1.0 (1.6 ) 2.6 11,822 11,930 (0.9 ) (0.1 ) (0.8 ) 15,202 14,490 4.9 3.8 1.1 29,075 28,052 3.6 4.0 (0.4 ) 4,383 4,059 8.0 8.0 - 8,596 8,067 6.6 6.6 - 4,158 3,898 6.7 4.1 2.6 7,965 7,711 3.3 3.6 (0.3 ) 8,541 7,957 7.3 6.1 1.2 16,561 15,778 5.0 5.1 (0.1 ) 13,544 12,569 7.8 7.8 - 25,849 24,189 6.9 6.9 - 10,199 9,878 3.2 0.6 2.6 19,787 19,641 0.7 1.4 (0.7 ) $ 23,743 22,447 5.8 % 4.6 1.2 $ 45,636 43,830 4.1 % 4.4 (0.3 ) Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency $ 13,544 12,569 7.8 % 7.8 - $ 25,849 24,189 6.9 % 6.9 - 5,387 5,214 3.3 (1.9 ) 5.2 10,497 10,377 1.1 0.2 0.9 1,206 1,212 (0.5 ) 6.2 (6.7 ) 2,373 2,406 (1.3 ) 7.7 (9.0 ) 3,606 3,452 4.4 2.4 2.0 6,917 6,858 0.9 0.9 0.0 10,199 9,878 3.2 0.6 2.6 19,787 19,641 0.7 1.4 (0.7 ) $ 23,743 22,447 5.8 % 4.6 1.2 $ 45,636 43,830 4.1 % 4.4 (0.3 ) 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 23,743 100.0 $ 22,447 100.0 5.8 7,628 32.1 6,869 30.6 11.0 16,115 67.9 15,578 69.4 3.4 5,889 24.8 5,681 25.3 3.7 3,516 14.8 3,440 15.3 2.2 - - 194 0.9 48 0.2 (125 ) (0.6 ) 107 0.5 653 2.9 64 0.3 (13 ) 0.0 6,491 27.3 5,748 25.6 12.9 954 4.0 1,062 4.7 (10.2 ) $ 5,537 23.3 $ 4,686 20.9 18.2 $ 2.29 $ 1.93 18.7 2,419.1 2,422.0 14.7 % 18.5 % $ 8,188 34.5 $ 8,404 37.4 (2.6 ) $ 6,699 28.2 $ 6,840 30.5 (2.1 ) $ 2.77 $ 2.82 (1.8 ) 18.2 % 18.6 % 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 45,636 100.0 $ 43,830 100.0 4.1 14,985 32.8 13,380 30.5 12.0 30,651 67.2 30,450 69.5 0.7 11,001 24.1 10,938 25.0 0.6 6,741 14.8 6,982 16.0 (3.5 ) - - 194 0.4 (80 ) (0.2 ) (334 ) (0.8 ) (7,214 ) (15.8 ) 3,057 7.0 81 0.2 151 0.3 20,122 44.1 9,462 21.6 112.7 3,586 7.9 1,521 3.5 135.8 $ 16,536 36.2 $ 7,941 18.1 108.2 $ 6.82 $ 3.27 108.6 2,423.3 2,428.5 17.8 % 16.1 % $ 16,199 35.5 $ 16,281 37.1 (0.5 ) $ 13,405 29.4 $ 13,420 30.6 (0.1 ) $ 5.53 $ 5.53 0.0 17.2 % 17.6 % 2025 2024 2025 2024 $5,537 $4,686 $16,536 $7,941 57 352 (6,909) 3,078 1,267 1,106 2,387 2,184 - 64 - 73 79 (11) 134 160 - 68 - 119 246 452 378 600 21 431 60 411 - 194 - 194 27 - 27 - (321) (437) 994 (1,293) (214) (65) (202) (47) $6,699 $6,840 $13,405 $13,420 2,419.1 2,422.0 2,423.3 2,428.5 $2.77 $2.82 $5.53 $5.53 $2.71 $5.52 1 2 4.9% 7.3% 5.8% 7.6% 8.0% 7.8% 1.0% 6.7% 3.2% 1.1 1.2 1.2 - - - 2.6 2.6 2.6 3.8% 6.1% 4.6% 7.6% 8.0% 7.8% (1.6)% 4.1% 0.6% (2.2) (0.8) (3.5) (1.1) (0.9) (0.3) (1.4) (0.9) (2.4) (1.7) 0.0 0.0 0.0 0.2 0.1 0.0 0.2 0.0 0.0 0.2 0.1 2.4% 4.1% 3.0% 5.2% 4.7% 5.0% (1.6)% 3.4% 0.4% Innovative Medicine MedTech Total 3.6% 5.0% 4.1% 7.0% 6.6% 6.9% (0.9)% 3.3% 0.7% (0.4) (0.1) (0.3) - - - (0.8) (0.3) (0.7) 4.0% 5.1% 4.4% 7.0% 6.6% 6.9% (0.1)% 3.6% 1.4% (2.7) (1.0) (4.3) (1.5) (1.1) (0.5) (0.8) (0.5) (1.3) (0.9) 0.0 0.0 0.1 0.3 0.2 0.0 0.5 0.2 0.2 0.2 0.2 3.3% 2.7% 3.1% 5.7% 2.8% 4.7% 0.1% 2.7% 1.1% REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 3,385 2,636 28.4 % 28.4 % - $ 6,398 5,019 27.5 % 27.5 % - 2,928 2,455 19.3 % 15.7 % 3.6 % 5,592 4,885 14.5 % 15.1 % -0.6 % 6,312 5,090 24.0 % 22.3 % 1.7 % 11,990 9,904 21.1 % 21.3 % -0.2 % 358 167 * * - 676 307 * * - 81 20 * * * 132 36 * * * 439 186 * * * 808 343 * * * 2,017 1,641 23.0 % 23.0 % - 3,846 3,105 23.9 % 23.9 % - 1,521 1,237 23.0 % 19.6 % 3.4 % 2,930 2,465 18.9 % 19.7 % -0.8 % 3,539 2,878 23.0 % 21.5 % 1.5 % 6,776 5,570 21.7 % 22.0 % -0.3 % 378 318 18.6 % 18.6 % - 670 603 11.0 % 11.0 % - 530 418 27.0 % 22.8 % 4.2 % 1,009 822 22.9 % 23.0 % -0.1 % 908 736 23.4 % 21.0 % 2.4 % 1,679 1,425 17.8 % 17.9 % -0.1 % 239 246 -2.7 % -2.7 % - 474 511 -7.3 % -7.3 % - 496 525 -5.4 % -8.4 % 3.0 % 970 1,043 -6.9 % -6.3 % -0.6 % 735 770 -4.5 % -6.6 % 2.1 % 1,444 1,554 -7.0 % -6.6 % -0.4 % 139 52 * * - 252 88 * * - 41 17 * * * 69 28 * * * 179 69 * * * 320 116 * * * 82 59 38.0 % 38.0 % - 150 109 36.7 % 36.7 % - 24 9 * * * 42 17 * * * 106 69 55.0 % 54.3 % 0.7 % 192 127 52.0 % 52.4 % -0.4 % 114 104 8.2 % 8.2 % - 219 205 6.6 % 6.6 % - 52 30 74.8 % 72.0 % 2.8 % 98 63 56.0 % 58.4 % -2.4 % 166 135 23.1 % 22.4 % 0.7 % 317 268 18.2 % 18.7 % -0.5 % 6 11 -38.9 % -38.9 % - 13 20 -31.9 % -31.9 % - 139 154 -9.8 % -13.3 % 3.5 % 257 326 -21.1 % -21.3 % 0.2 % 145 165 -11.6 % -14.9 % 3.3 % 270 346 -21.7 % -21.9 % 0.2 % 50 37 36.9 % 36.9 % - 97 70 39.8 % 39.8 % - 42 45 -8.7 % -12.3 % 3.6 % 84 86 -2.5 % -1.8 % -0.7 % 93 83 11.7 % 9.7 % 2.0 % 182 156 16.4 % 16.8 % -0.4 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 2,505 2,978 -15.9 % -15.9 % - $ 4,701 5,431 -13.4 % -13.4 % - 1,489 1,744 -14.6 % -16.2 % 1.6 % 2,999 3,538 -15.2 % -13.8 % -1.4 % 3,993 4,722 -15.4 % -16.0 % 0.6 % 7,700 8,969 -14.1 % -13.6 % -0.5 % 283 231 22.5 % 22.5 % - 597 497 20.1 % 20.1 % - 34 35 -2.6 % -2.6 % - 44 62 -28.7 % -28.7 % - 138 127 8.6 % 8.8 % -0.2 % 281 268 4.8 % 7.7 % -2.9 % 455 393 15.9 % 15.9 % 0.0 % 922 827 11.5 % 12.4 % -0.9 % 305 267 14.0 % 14.0 % - 597 521 14.4 % 14.4 % - 387 270 43.1 % 40.8 % 2.3 % 753 569 32.2 % 35.0 % -2.8 % 690 537 28.6 % 27.5 % 1.1 % 1,349 1,091 23.7 % 25.1 % -1.4 % 1,078 1,855 -41.9 % -41.9 % - 2,059 3,251 -36.7 % -36.7 % - 575 1,030 -44.2 % -45.6 % 1.4 % 1,219 2,085 -41.5 % -40.6 % -0.9 % 1,653 2,885 -42.7 % -43.2 % 0.5 % 3,278 5,336 -38.6 % -38.2 % -0.4 % 796 589 35.2 % 35.2 % - 1,395 1,098 27.1 % 27.1 % - 391 317 23.2 % 20.5 % 2.7 % 747 616 21.2 % 22.4 % -1.2 % 1,186 906 31.0 % 30.1 % 0.9 % 2,142 1,714 25.0 % 25.4 % -0.4 % 8 2 * * - 9 2 * * - 0 0 - - - 0 0 - - - 8 2 * * - 9 2 * * - 1,377 1,102 24.9 % 24.9 % - 2,345 2,156 8.7 % 8.7 % - 674 679 -0.8 % -2.6 % 1.8 % 1,353 1,428 -5.2 % -4.1 % -1.1 % 2,051 1,782 15.1 % 14.4 % 0.7 % 3,698 3,585 3.2 % 3.6 % -0.4 % 211 - * * - 211 - * * - - - - - - - - - - - 211 - * * - 211 - * * - 24 34 -27.7 % -27.7 % - 62 75 -16.6 % -16.6 % - 139 129 7.5 % 7.0 % 0.5 % 249 265 -6.0 % -4.4 % -1.6 % 164 163 0.2 % -0.2 % 0.4 % 312 340 -8.3 % -7.1 % -1.2 % 732 784 -6.7 % -6.7 % - 1,357 1,549 -12.4 % -12.4 % - 260 269 -3.5 % -5.1 % 1.6 % 537 561 -4.2 % -3.1 % -1.1 % 992 1,054 -5.9 % -6.3 % 0.4 % 1,895 2,110 -10.2 % -9.9 % -0.3 % 366 226 61.1 % 61.1 % - 642 417 53.7 % 53.7 % - 50 44 12.8 % 11.0 % 1.8 % 93 78 18.1 % 20.1 % -2.0 % 414 271 53.3 % 53.0 % 0.3 % 734 496 48.1 % 48.4 % -0.3 % 45 57 -23.5 % -23.5 % - 73 115 -37.0 % -37.0 % - 226 237 -4.7 % -7.6 % 2.9 % 474 524 -9.5 % -8.8 % -0.7 % 270 294 -8.4 % -10.7 % 2.3 % 547 639 -14.4 % -13.9 % -0.5 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 799 743 7.6 % 7.6 % - $ 1,543 1,509 2.3 % 2.3 % - 314 296 5.8 % 2.8 % 3.0 % 595 579 2.6 % 3.0 % -0.4 % 1,113 1,039 7.1 % 6.2 % 0.9 % 2,138 2,088 2.4 % 2.5 % -0.1 % 403 376 6.9 % 6.9 % - 766 732 4.6 % 4.6 % - 180 171 5.4 % 2.1 % 3.3 % 339 340 -0.3 % -0.2 % -0.1 % 582 548 6.4 % 5.4 % 1.0 % 1,104 1,072 3.0 % 3.1 % -0.1 % 382 349 9.4 % 9.4 % - 747 741 0.8 % 0.8 % - 94 76 22.4 % 19.8 % 2.6 % 180 152 17.9 % 18.7 % -0.8 % 476 426 11.7 % 11.3 % 0.4 % 927 894 3.7 % 3.8 % -0.1 % 16 17 -12.4 % -12.4 % - 31 35 -12.6 % -12.6 % - 40 49 -18.5 % -21.3 % 2.8 % 77 88 -12.4 % -12.1 % -0.3 % 55 67 -16.9 % -19.0 % 2.1 % 107 123 -12.5 % -12.3 % -0.2 % 320 334 -4.3 % -4.3 % - 635 658 -3.6 % -3.6 % - 484 631 -23.4 % -26.8 % 3.4 % 971 1,128 -13.9 % -14.1 % 0.2 % 803 965 -16.8 % -19.0 % 2.2 % 1,605 1,786 -10.1 % -10.2 % 0.1 % 6 8 -25.4 % -25.4 % - 14 16 -13.6 % -13.6 % - 354 288 23.0 % 16.7 % 6.3 % 704 603 16.7 % 15.6 % 1.1 % 360 297 21.6 % 15.5 % 6.1 % 718 620 15.9 % 14.9 % 1.0 % 312 321 -3.0 % -3.0 % - 617 635 -2.9 % -2.9 % - 85 117 -27.0 % -29.4 % 2.4 % 183 221 -17.2 % -15.8 % -1.4 % 396 438 -9.4 % -10.0 % 0.6 % 799 856 -6.6 % -6.3 % -0.3 % 2 5 -51.8 % -51.8 % - 4 7 -37.4 % -37.4 % - 45 227 -80.5 % -80.6 % 0.1 % 84 304 -72.5 % -72.1 % -0.4 % 47 233 -79.8 % -79.9 % 0.1 % 88 311 -71.7 % -71.3 % -0.4 % 776 717 8.2 % 8.2 % - 1,631 1,348 21.0 % 21.0 % - 154 176 -12.3 % -13.2 % 0.9 % 312 373 -16.2 % -14.3 % -1.9 % 930 892 4.2 % 4.0 % 0.2 % 1,943 1,721 12.9 % 13.3 % -0.4 % 621 587 5.6 % 5.6 % - 1,311 1,105 18.6 % 18.6 % - - - - - - - - - - - 621 587 5.6 % 5.6 % - 1,311 1,105 18.6 % 18.6 % - 155 129 20.0 % 20.0 % - 320 243 31.6 % 31.6 % - 154 176 -12.3 % -13.2 % 0.9 % 312 373 -16.2 % -14.3 % -1.9 % 309 305 1.4 % 0.9 % 0.5 % 632 616 2.7 % 3.9 % -1.2 % 9,161 8,510 7.6 % 7.6 % - 17,253 16,122 7.0 % 7.0 % - 6,041 5,980 1.0 % -1.6 % 2.6 % 11,822 11,930 -0.9 % -0.1 % -0.8 % $ 15,202 14,490 4.9 % 3.8 % 1.1 % $ 29,075 28,052 3.6 % 4.0 % -0.4 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 1,364 1,119 21.9 % 21.9 % - $ 2,625 2,144 22.4 % 22.4 % - 948 753 25.9 % 22.9 % 3.0 % 1,790 1,534 16.7 % 16.7 % 0.0 % 2,313 1,873 23.5 % 22.3 % 1.2 % 4,416 3,679 20.0 % 20.0 % 0.0 % 741 705 5.1 % 5.1 % - 1,425 1,397 2.0 % 2.0 % - 728 618 17.8 % 15.2 % 2.6 % 1,366 1,270 7.6 % 7.8 % -0.2 % 1,468 1,323 11.0 % 9.8 % 1.2 % 2,791 2,667 4.7 % 4.7 % 0.0 % 360 309 16.6 % 16.6 % - 699 612 14.2 % 14.2 % - 89 72 25.0 % 18.4 % 6.6 % 170 139 22.4 % 20.9 % 1.5 % 448 379 18.2 % 16.9 % 1.3 % 868 750 15.7 % 15.5 % 0.2 % 233 77 * * - 439 77 * * - 58 0 * * * 110 0 * * * 292 77 * * * 550 77 * * - 31 29 5.4 % 5.4 % - 63 59 6.3 % 6.3 % - 72 64 13.4 % 11.6 % 1.8 % 144 126 14.2 % 14.5 % -0.3 % 104 93 10.8 % 9.7 % 1.1 % 207 185 11.7 % 11.8 % -0.1 % 1,420 1,422 -0.2 % -0.2 % - 2,804 2,870 -2.3 % -2.3 % - 885 890 -0.5 % -4.0 % 3.5 % 1,742 1,782 -2.2 % -2.4 % 0.2 % 2,305 2,312 -0.3 % -1.6 % 1.3 % 4,546 4,652 -2.3 % -2.3 % 0.0 % 271 265 2.1 % 2.1 % - 534 535 -0.2 % -0.2 % - 150 152 -1.0 % -4.3 % 3.3 % 296 304 -2.5 % -2.6 % 0.1 % 421 417 1.0 % -0.2 % 1.2 % 830 839 -1.1 % -1.1 % 0.0 % 226 230 -1.9 % -1.9 % - 457 472 -3.1 % -3.1 % - 164 163 0.0 % -2.9 % 2.9 % 322 323 -0.5 % -0.4 % -0.1 % 389 394 -1.1 % -2.3 % 1.2 % 778 795 -2.0 % -2.0 % 0.0 % 501 498 0.7 % 0.7 % - 1,003 1,002 0.1 % 0.1 % - 267 260 2.2 % -1.5 % 3.7 % 537 521 2.9 % 2.8 % 0.1 % 768 759 1.2 % -0.1 % 1.3 % 1,540 1,524 1.1 % 1.0 % 0.1 % 422 430 -1.7 % -1.7 % - 810 862 -6.0 % -6.0 % - 305 314 -2.7 % -6.4 % 3.7 % 588 634 -7.2 % -7.7 % 0.5 % 727 743 -2.1 % -3.7 % 1.6 % 1,398 1,495 -6.5 % -6.7 % 0.2 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 1,043 995 4.8 % 4.8 % - $ 2,045 1,982 3.2 % 3.2 % - 1,512 1,493 1.3 % -0.2 % 1.5 % 2,906 2,922 -0.5 % 0.3 % -0.8 % 2,555 2,488 2.7 % 1.8 % 0.9 % 4,951 4,904 1.0 % 1.5 % -0.5 % 477 466 2.2 % 2.2 % - 934 912 2.4 % 2.4 % - 687 675 1.9 % 0.2 % 1.7 % 1,303 1,316 -1.0 % -0.4 % -0.6 % 1,164 1,141 2.0 % 1.0 % 1.0 % 2,237 2,228 0.4 % 0.8 % -0.4 % 567 528 7.2 % 7.2 % - 1,111 1,070 3.8 % 3.8 % - 825 818 0.9 % -0.6 % 1.5 % 1,603 1,606 -0.1 % 0.8 % -0.9 % 1,391 1,346 3.3 % 2.5 % 0.8 % 2,714 2,676 1.4 % 2.0 % -0.6 % 557 523 6.5 % 6.5 % - 1,123 1,070 4.9 % 4.9 % - 813 763 6.5 % 3.4 % 3.1 % 1,526 1,473 3.6 % 3.7 % -0.1 % 1,369 1,285 6.5 % 4.6 % 1.9 % 2,648 2,543 4.1 % 4.2 % -0.1 % 429 409 4.8 % 4.8 % - 881 847 3.9 % 3.9 % - 536 509 5.4 % 1.4 % 4.0 % 1,003 981 2.3 % 1.9 % 0.4 % 965 918 5.1 % 2.9 % 2.2 % 1,884 1,828 3.1 % 2.8 % 0.3 % 128 113 12.6 % 12.6 % - 242 223 8.5 % 8.5 % - 277 254 8.8 % 7.3 % 1.5 % 523 492 6.2 % 7.2 % -1.0 % 403 367 9.9 % 8.9 % 1.0 % 764 715 6.9 % 7.6 % -0.7 % 4,383 4,059 8.0 % 8.0 % - 8,596 8,067 6.6 % 6.6 % - 4,158 3,898 6.7 % 4.1 % 2.6 % 7,965 7,711 3.3 % 3.6 % -0.3 % $ 8,541 7,957 7.3 % 6.1 % 1.2 % $ 16,561 15,778 5.0 % 5.1 % -0.1 % Second Quarter June 29, 2025 GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related Other Second Quarter June 29, 2025 Non-GAAP $ 3,978 (785 ) (13 ) 3,180 2,789 2,789 2,869 2,869 14 69 (207 ) 8 (13 ) (129 ) 5,552 785 (69 ) - 220 (8 ) - 13 6,493 $ 3,638 (482 ) (15 ) 1 3,142 2,862 2,862 647 43 690 190 (83 ) (64 ) (53 ) (29 ) (14 ) (53 ) 1,204 482 83 79 9 29 - 14 1,900 $ 12 12 238 238 - - 15 (43 ) (17 ) (45 ) (265 ) - 43 - 17 - - - (205 ) $ 7,628 (1,267 ) (15 ) (12 ) 6,334 5,889 5,889 3,516 43 3,559 107 (57 ) (277 ) (21 ) (27 ) (275 ) - - 48 48 64 (64 ) - 6,491 1,267 57 79 246 21 - 27 8,188 954 222 9 13 72 5 214 - 1,489 5,537 1,045 48 66 174 16 (214 ) 27 6,699 $ 3,603 (694 ) (4 ) 2,905 2,665 2,665 2,722 (10 ) 2,712 41 (43 ) (194 ) 63 (1 ) (70 ) (50 ) (254 ) 5,459 694 43 194 (63 ) 1 70 - 64 - 6,462 $ 3,248 (412 ) (2 ) (50 ) (30 ) 2,754 2,671 (5 ) 2,666 718 (15 ) (33 ) 670 231 4 (50 ) (344 ) (22 ) (181 ) 1,089 412 (4 ) - 52 409 22 68 - - 2,048 $ 18 18 345 345 - - 437 (313 ) (42 ) (339 ) (257 ) (800 ) - 313 - - 42 339 - - - (106 ) $ 6,869 (1,106 ) (2 ) (50 ) (30 ) (4 ) 5,677 5,681 (5 ) 5,676 3,440 (15 ) (33 ) (10 ) 3,382 653 (352 ) (387 ) (431 ) (50 ) (567 ) 194 (194 ) - (125 ) (125 ) (13 ) 13 - 5,748 1,106 352 194 (11 ) 452 431 68 64 - 8,404 1,062 156 70 43 (6 ) 125 21 14 14 65 1,564 4,686 950 282 151 (5 ) 327 410 54 50 (65 ) 6,840 Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions $ 7,998 (1,434 ) (13 ) 6,551 5,050 5,050 5,417 5,417 (152 ) 69 (227 ) (10 ) (13 ) (333 ) 10,762 1,434 (69 ) - 240 10 - 13 12,390 $ 6,964 (953 ) (23 ) (51 ) 5,937 5,518 5,518 1,324 37 1,361 130 (83 ) (111 ) (107 ) (50 ) (14 ) (235 ) 2,625 953 83 134 121 50 - 14 3,980 $ 23 23 433 433 - - (7,191 ) 6,923 (17 ) (285 ) 6,735 - (6,923 ) - 17 - - - (171 ) $ 14,985 (2,387 ) (23 ) (64 ) 12,511 11,001 11,001 6,741 37 6,778 (7,214 ) 6,909 (30 ) (351 ) (60 ) (27 ) (773 ) - - (80 ) (80 ) 81 (81 ) - 20,122 2,387 (6,909 ) 134 378 60 - 27 16,199 3,586 410 (1,544 ) 24 102 14 202 2,794 16,536 1,977 (5,365 ) 110 276 46 (202 ) 27 13,405 $ 6,973 (1,392 ) (6 ) 5,575 5,103 5,103 5,618 (17 ) 5,601 (70 ) (43 ) (194 ) (81 ) (48 ) (15 ) (50 ) (501 ) 10,428 1,392 43 194 81 48 15 - 73 - 12,274 $ 6,368 (792 ) (9 ) (50 ) (50 ) 5,467 5,253 (9 ) 5,244 1,364 (33 ) (60 ) 1,271 184 4 (70 ) (387 ) (44 ) (313 ) 2,609 792 (4 ) - 79 470 44 119 - - 4,109 $ 39 39 582 582 - - 2,954 (3,039 ) (82 ) (352 ) (519 ) (3,575 ) - 3,039 - - 82 352 - - - (102 ) $ 13,380 (2,184 ) (9 ) (50 ) (50 ) (6 ) 11,081 10,938 (9 ) 10,929 6,982 (33 ) (60 ) (17 ) 6,872 3,057 (3,078 ) (517 ) (411 ) (50 ) (999 ) 194 (194 ) - (334 ) (334 ) 151 (151 ) - 9,462 2,184 3,078 194 160 600 411 119 73 - 16,281 1,521 304 697 43 33 163 14 23 16 47 2,861 7,941 1,880 2,381 151 127 437 397 96 57 (47 ) 13,420 Media contact: media-relations@its.jnj.com Investor contact: investor-relations@its.jnj.com

Clinical ResultDrug ApprovalFinancial Statement

20 Jun 2025

·www.fiercepharma.com

Europe's CHMP gives thumbs up to ExCellThera's blood cancer cell therapy Zemcelpro

Europe’s Committee for Medicinal Products for Human Use has recommended marketing authorization for ExCellThera’s novel cell therapy Zemcelpro in certain blood cancer patients. In a first for the bloc, Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for a new type of stem cell transplant therapy for certain blood cancer patients. The marketing endorsement was awarded to ExCellThera’s Zemcelpro and covers a recommended approval in adults with blood cancers that require an allogeneic hematopoietic stem cell transplantation (HSCT) following myeloablative conditioning for whom no other type of suitable donor cells is available.Zemcelpro contains stem cells from a donor’s umbilical cord blood, some of which have been grown and multiplied, the European Medicines Agency (EMA) said in a press release on the decision. By boosting the number of cells, Zemcelpro makes the stem cells from a small cord blood unit more effective, the European regulator explained. For several blood cancers—including leukemias, which are detected in the blood; lymphomas, which are found in the lymph nodes; and myelodysplastic syndrome and myelomas, which are diagnosed in the bone marrow—the only current curative treatment option is allogeneic HSCT. This type of transplant involves using donated stem cells to replace the patient’s bone marrow cells to form new marrow that produces healthy blood cells. The CHMP based its Zemcelpro recommendation on pooled analysis of two single-arm trials that included 25 patients. The studies found that 84% of patients who received Zemcelpro achieved neutrophil engraftment, when donor stem cells establish themselves in the recipient’s bone marrow and produce the white blood cells known as neutrophils within a median span of 20 days.Some 10,000 new blood cancer cases requiring bone marrow transplant crop up in Europe each year, ExCellThera estimates. Many of these patients do not have access to suitable donor cells largely because of the unavailability of matched donors, the company explained. ExCellThera said it expects to gain marketing authorization from the EMA in roughly two months' time. After winning an endorsement from the CHMP, prospective medicines must go before the European Commission for a final approval verdict.ExCellThera also plans to file for approval of Zemcelpro in the U.S., U.K. and other countries. Madrigal’s Rezdiffra among others gaining CHMP nodsThe committee has also given a thumbs up to Madrigal’s Rezdiffra for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), a disease where fat cells accumulate in the liver causing chronic inflammation. If the drug gains marketing authorization, it would become the first treatment in the EU for the condition. Fifteen months ago, Rezdiffra became the first drug approved for MASH in the U.S. Also making the grade this month was Teva blockbuster Austedo for patients with moderate-to-severe tardive dyskinesia. The FDA approved the treatment in the indication eight years ago. Tardive dyskinesia is an irreversible movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities and can be caused by medications used to treat mental health or gastrointestinal conditions.Meanwhile, Pfizer spinout SpringWorks Therapeutics has picked up a CHMP nod for Ogsiveo in adults with progressing desmoid tumors, which are marked by noncancerous soft tissue growths in the limbs and abdomen that often cause severe pain and disfigurement. The FDA approved Ogsiveo in the same indication in 2023.Also gaining a positive recommendation from the CHMP was Partner Therapeutics’ Imreplys for the treatment of patients exposed to myelosuppressive doses of radiation with hematopoietic sub-syndrome of acute radiation syndrome. The medicine is known as Leukine in the U.S. where it was approved in 2018. CHMP signs off on label expansions for 6 drugsAside from new approval recommendations, the CHMP has also endorsed labeled expansions for a half-dozen established medicines. The committee gave a thumbs up to Ipsen’s Cabometyx as a second-line treatment for patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumors. The FDA signed off Cabometyx in the indication three months ago. The treatment, which has been on the market since 2016, brought home sales of $1.8 billion last year.Also winning CHMP recommendations were Johnson & Johnson blockbusters Darzalex, for smoldering multiple myeloma, and Imbruvica, for patients with previously treated mantle cell lymphoma who would be eligible for autologous stem cell transplant. AbbVie partners with J&J on Imbruvica.The committee further signed off on expansions for GSK’s lupus treatment Benlysta, Bayer’s prostate cancer drug Nubeqa and Sanofi’s multiple myeloma medicine Sarclisa. CHMP opens re-examination of Lilly’s KisunlaElsewhere, fifteen months after giving a thumbs down to Eli Lilly’s Alzheimer’s disease treatment Kisunla in March of last year, the CHMP will give the medication a second look. The regulator said that it re-opened its examination of Kisunla on June 2. The FDA signed off on Kisunla in July of last year, opening up competition with Eisai and Biogen’s Alzheimer's rival Leqembi.

Drug ApprovalCell TherapyClinical Result

17 Jun 2025

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The End Brain Cancer Initiative Partners with Curis to Pre-qualify for PCNSL TakeAim Lymphoma Clinical Trial

The End Brain Cancer Initiative Partners with Curis to Promote Awareness and Pre-qualify for PCNSL TakeAim Lymphoma Clinical Trial REDMOND, WA, UNITED STATES, June 16, 2025 / EINPresswire.com / -- FOR IMMEDIATE RELEASE Contact: Dellann Elliott Mydland, 425-785-8489, Dellann@EndBrainCancer.org The End Brain Cancer Initiative Partners with Curis to Promote Awareness and Pre-qualify for PCNSL TakeAim Lymphoma Clinical Trial The End Brain Cancer Initiative (EBCI) has partnered with Curis to promote awareness and pre-qualify patients for the company’s TakeAim Lymphoma Clinical Trial (CA-4948-101) clinical trial, an open-label, dose escalation and expansion trial of Emavusertib in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL) (NCT03328078). “We are proud to partner with the End Brain Cancer Initiative to help raise awareness for primary CNS lymphoma (PCNSL), a rare and challenging form of cancer non-Hodgkin lymphoma. Together, we aim to highlight the unmet medical needs of this patient community, provide relevant resources to patients and their care providers, along with increasing awareness of clinical trials,” shared the Chief Medical Officer of Curis Inc, Ahmed Hamdy, MD. “Curis is committed to developing emavusertib for the treatment of PCNSL and broader non-Hodgkin lymphoma indications.” Patients who would like to learn more about this clinical trial and see if they qualify can visit https://endbraincancer.org/curis-therapeutics/ or contact the End Brain Cancer Initiative’s Clinical Research Coordinator and Patient Navigator, Shreya Prakash, at Shreya@EndBrainCancer.org or 425-436-8688. About Curis Curis, located in Lexington, Massachusetts, is a biotechnology company focused on the development of Emavusertib, an orally available, small molecule IRAK4 inhibitor. Emavusertib is currently being evaluated in the TakeAim Lymphoma Phase 1/2 study (CA-4948-101) in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) in combination with the BTK inhibitor ibrutinib, as a monotherapy in the TakeAim Leukemia Phase 1/2 study (CA-4948-102) in patients with relapsed/refractory acute myeloid leukemia (AML) and relapsed/refractory high risk myelodysplastic syndrome (hrMDS), and as a frontline combination therapy with venetoclax and azacitidine in patents with AML (CA-4948-104). Emavusertib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of PCNSL, AML and MDS and from the European Commission for the treatment of PCNSL. Curis, through its 2015 collaboration with Aurigene, has the exclusive license to Emavusertib (CA-4948). Curis licensed its rights to Erivedge ® to Genentech, a member of the Roche Group, under which they are commercializing Erivedge ® for the treatment of advanced basal cell carcinoma. For more information, visit Curis's website at https://www.curis.com/ . About the End Brain Cancer Initiative To support/donate to the End Brain Cancer Initiative’s increased access and health delivery for patients, mission, services and programs, please visit EndBrainCancer.org The End Brain Cancer Initiative (EBCI) is a 501(c)3 non-profit patient advocacy organization focused on disease education, awareness, outreach, increasing patient access and improving Standard of Care. The End Brain Cancer Initiative, formerly known as the Chris Elliott Fund (CEF), is dedicated to ensuring that all patients diagnosed with brain cancer, a brain tumor, or metastatic disease to the brain have equal access to advanced diagnostics, treatments, specialists, and clinical trial participation. We believe that IMMEDIATE ACCESS to these options provides this patient community with the best HOPE for survival and sustained quality of life. We partner with industry, patients, researchers, advocacy groups, medical teams, hospital networks and others to educate patients and their caregivers so they can have empowered conversations with their medical teams. Learn more about the End Brain Cancer Initiative or how to sponsor this annual campaign at EndBrainCancer.org. Dellann Elliott Mydland, End Brain Cancer Initiative, 425-785-8489, Dellann@EndBrainCancer.org ### Dellann Elliott Mydland End Brain Cancer Initiative +1 425-785-8489 email us here Visit us on social media: LinkedIn Instagram Facebook YouTube X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 1Orphan DrugLicense out/inDrug Approval

100 Deals associated with Ibrutinib

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KEGG	Wiki	ATC	Drug Bank
D10223	Ibrutinib	L01XE27	DB09053

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Lymphoplasmacytic Lymphoma	Japan	Janssen Pharmaceutical KK	23 Dec 2022
Marginal Zone B-Cell Lymphoma	United States	Pharmacyclics LLC	18 Jan 2017
Chronic graft-versus-host disease	Mexico	Janssen-Cilag SA de CV	01 Mar 2015
Small Lymphocytic Lymphoma	Mexico	Janssen-Cilag SA de CV	01 Mar 2015
Mantle cell lymphoma recurrent	European Union	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma recurrent	Iceland	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma recurrent	Liechtenstein	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma recurrent	Norway	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma refractory	European Union	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma refractory	Iceland	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma refractory	Liechtenstein	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma refractory	Norway	Janssen-Cilag International NV	21 Oct 2014
Waldenstrom Macroglobulinemia	South Korea	Janssen Korea Ltd.	08 Aug 2014
Chronic Lymphocytic Leukemia	United States	Pharmacyclics LLC	12 Feb 2014
Mantle-Cell Lymphoma	United States	Pharmacyclics LLC	13 Nov 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Waldenstrom's macroglobulinaemia recurrent	Phase 3	United Kingdom	Janssen-Cilag Ltd.	03 Feb 2020
Hepatitis B, Chronic	Phase 3	Hong Kong	Janssen LP	01 Nov 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	United States	Janssen Research & Development LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	United States	Pharmacyclics LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Belgium	Janssen Research & Development LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Belgium	Pharmacyclics LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Brazil	Pharmacyclics LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Brazil	Janssen Research & Development LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Bulgaria	Janssen Research & Development LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Bulgaria	Pharmacyclics LLC	01 Jul 2016

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04230304 (CTgov)	Phase 2	Recurrent Chronic Lymphoid Leukemia \| Chronic lymphocytic leukaemia refractory \| Refractory Small Lymphocytic Lymphoma	8	Ibrutinib+Daratumumab	odxqexmdng = vtvdclvovu rrpccpmqtm (bbggrfvthc, ymbkseaqgu - inwihsvpxt) View more	-	01 Jul 2025
RESONATE-2; ELEVATE-TN; SEQUOIA (ASCO2025)	Phase 3	Chronic Lymphocytic Leukemia First line	537	Ibrutinib	lozjyroqkx(hnosmycmmy) = abmkefrqow ezqpgcyauj (gmnxblurfm, 75.6 - 92.1) View more	Positive	30 May 2025
RESONATE-2; ELEVATE-TN; SEQUOIA (ASCO2025)	Phase 3	Chronic Lymphocytic Leukemia First line	537	Acalabrutinib	lozjyroqkx(hnosmycmmy) = qdkbbmxlhl ezqpgcyauj (gmnxblurfm, 67.5 - 81.1) View more	Positive	30 May 2025
NCT03112174 (SYMPATICO, ASCO2025)	Phase 3	Mantle-Cell Lymphoma First line	78	Ibrutinib 560 mg + Venetoclax 400 mg	fbhvtkeryd(zsruubdnuo) = apveagahwn vagzxiqgje (ldkrjezbyb, 87 - 99) View more	Positive	30 May 2025
NCT04802590 (OASIS II, ASCO2025)	Phase 2	Mantle-Cell Lymphoma	102	Ibrutinib/CD20mAb	nmpkiyyzxd(jigfmgssxy) = oohkxtjsia ovsvirhhdb (wyjpaexkpx, 42.4% - 65%) View more	Positive	30 May 2025
NCT04802590 (OASIS II, ASCO2025)	Phase 2	Mantle-Cell Lymphoma	102	Ibrutinib/CD20mAb/Venetoclax	nmpkiyyzxd(jigfmgssxy) = uhawkhhiwf ovsvirhhdb (wyjpaexkpx, 71.7% - 89.7%) View more	Positive	30 May 2025
NCT02910583 (CAPTIVATE, ASCO2025)	Phase 2	Small Lymphocytic Lymphoma First line del(17p) \| unmutated IGHV \| mutated IGHV ... View more	202	Ibrutinib + Venetoclax	zqercoslkm(imeyvqtqft) = occurred in 24 pts across the entire study period, including 12 initial treatment and 4 retreatment TEAEs zhbovrxqxs (aepxqpnezq )	Positive	30 May 2025
RESONATE-2, ELEVATE-TN, SEQUOIA (EHA2025)	Phase 3	Chronic Lymphocytic Leukemia First line	537	Ibrutinib	mzphabvlwk(xkjahwohml) = hofncfhagp kabvejxqye (tzlgrdsvhd, 75.6 - 92.1) View more	Positive	22 May 2025
RESONATE-2, ELEVATE-TN, SEQUOIA (EHA2025)	Phase 3	Chronic Lymphocytic Leukemia First line	537	Acalabrutinib	mzphabvlwk(xkjahwohml) = winjwghilt kabvejxqye (tzlgrdsvhd, 67.5 - 81.1) View more	Positive	22 May 2025
SYMPATICO (EHA2025)	Phase 3	Mantle-Cell Lymphoma First line TP53 mutation	78	Ibrutinib 560 mg + Venetoclax 400 mg	eqpbslghhj(fdshyqthfm) = brxiqfhcde mpuhqctavx (paxodvvkhh ) View more	Positive	22 May 2025
CAPTIVATE (EHA2025)	Phase 2	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma First line unmutated IGHV \| mutated IGHV \| uMRD4	202	Ibrutinib + Venetoclax	hxrslprabo(xwtzketodv) = 24 patients across the entire study period, including 12 initial treatment and 4 retreatment treatment-emergent adverse events zccbhtuyqp (ezdenemlzd )	Positive	22 May 2025
LI+VE (EHA2025)	Not Applicable	Small Lymphocytic Lymphoma del(17p)/TP53 mutation	93	Ibrutinib+Venetoclax	qyutahajfa(hjvwiovqwr) = cidlwxowgg kjndgvcmri (muzjoysavb ) View more	-	14 May 2025
PF704 (EHA2025)	Not Applicable	Waldenstrom Macroglobulinemia MYD88 \| CXCR4 \| ARID1A ... View more	110	Ibrutinib	tmamkhkfjb(dixpapbugu) = aaldsfolxh focoyhjlza (udlyutiqpu ) View more	-	14 May 2025
PF704 (EHA2025)	Not Applicable		110	Ibrutinib (Responder Group (RG))	kskhmalxje(kfphohhcif) = ytgcfafvte qtxuuetmho (azaqbhylfw )	-	14 May 2025

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