CD3 stimulants(T cell surface glycoprotein CD3 stimulants), GPRC5D inhibitors(G-protein coupled receptor family C group 5member D inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Refractory Multiple MyelomaRelapse multiple myelomaMultiple Myeloma+ [6]

Inactive Indication-

Originator Organization

Janssen Pharmaceuticals, Inc.

Active Organization

Johnson & Johnson (China) Investment Ltd.Janssen Research & Development LLCJanssen-Cilag Pty Ltd.

+ [9]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (09 Aug 2023),

Multiple Myeloma

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Conditional marketing approval (European Union), Breakthrough Therapy (China), Priority Review (China)

Structure/Sequence

Sequence Code 10086313H

Source: *****

Sequence Code 10086327L

Source: *****

Sequence Code 453116282H

Source: *****

Sequence Code 525754800L

Source: *****

Clinical Trials associated with Talquetamab

NCT07474961

/ Not yet recruitingPhase 4IIT

A Multicentre, Adaptive, Randomised, Multidomain, Platform Trial for Dose Optimization in the Treatment of Adult Patients With Haematological Diseases (BLOOD-dose): Core Protocol

BLOOD-dose is a multicentre, adaptive, randomized, multidomain platform trial designed to optimize treatment dosing strategies in adult patients with haematological diseases.
The BLOOD-dose core protocol outlines the overall clinical trial design that applies to all included interventions, while domain-specific appendices (DSA) detail the unique characteristics of each domain and specify domain-specific interventions.
New domains will be incorporated over time to address distinct dose-optimization research questions across different haematological conditions and interventions.

Start Date01 Mar 2027

Sponsor / Collaborator

Rigshospitalet

NCT07657312

/ RecruitingPhase 2IIT

Phase 2 Study of Cytokine Release Syndrome Prophylaxis With Infliximab for Teclistamab/Talquetamab Therapy in Patients With Relapsed/Refractory Myeloma

This phase II trial tests how well giving infliximab works for the prevention of cytokine release syndrome (CRS) during treatment with teclistamab or talquetamab in patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). CRS and neurologic toxicity (damage to the nervous system which includes the brain, spinal cord, and nerves) are potential risks of treatment with talquetamab and teclistamab. CRS involves a release of a large amount of proteins into the bloodstream causing inflammation. This may cause changes in blood pressure and heartbeat, flu-like symptoms (nausea, fever, and chills), and/or affect the lung/liver/kidney function. It may also cause certain brain-related symptoms, such as dizziness, weakness, confusion, difficulty speaking, and/or decreased brain function (possible paralysis and/or coma). Infliximab is a drug that prevents the tumor necrosis factor-alpha (TNF-α) from working. TNF-α is a cytokine, or chemical messenger, that helps your immune system produce inflammation. Giving infliximab may work well for the prevention of cytokine release syndrome during treatment with teclistamab or talquetamab in patients with relapsed or refractory multiple myeloma.

Start Date01 Aug 2026

Sponsor / Collaborator

Ohio State University Comprehensive Cancer Center

[+2]

NCT07649525

/ RecruitingPhase 3IIT

iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma

iFIT is a trial for newly diagnosed transplant-ineligible patients with the bone marrow cancer myeloma. These patients are generally older and have a lower level of fitness than others. Patients can take part if their doctor would otherwise recommend the standard NHS treatment daratumumab, lenalidomide and dexamethasone (DRd). After six months of DRd, the subsequent treatment a patient receives in iFIT is based on two factors: the patient's fitness level and treatment response. The trial compares different treatment strategies to determine whether outcomes can be improved for specific patient groups.

Start Date01 Jul 2026

Sponsor / Collaborator

University of Leeds

[+3]

100 Clinical Results associated with Talquetamab

100 Translational Medicine associated with Talquetamab

100 Patents (Medical) associated with Talquetamab

133

Literatures (Medical) associated with Talquetamab

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Costs per responder for patients with relapsed or refractory multiple myeloma treated with Talquetamab compared with usual care

Article

Author: Mu, Fan ; Patel, Neel ; Yang, Chelsey ; Jiao, Tianze ; Liu, Yi-Hsuan ; Grajales-Cruz, Ariel F. ; Lee, Hans C. ; Zhang, Xinke ; Wang, Jiamin ; Goble, Joseph

AIMS:

To evaluate costs per responder for patients with triple-class exposed (TCE) relapsed or refractory multiple myeloma (RRMM) receiving talquetamab (Tal) on weekly (QW) and biweekly (Q2W) dosing schedules, compared with usual care from a United States commercial payer's perspective.

METHODS:

A cost per responder model was developed over a 6-month time horizon, incorporating pre-progression and post-progression costs. For Tal QW and Tal Q2W, pre-progression costs included costs of drug acquisition, inpatient step-up doses (hospitalization, pre-medication, and tocilizumab), outpatient visits, and monitoring. Pre-progression costs for usual care were estimated based on a weighted average of the 10 most used regimens in a real-world LocoMMotion/MoMMent study, including costs of acquisition, administration, co-medication, and monitoring. Post-progression costs included subsequent treatment for a subset of patients and terminal care costs prior to death. All costs were reported in 2025 United States Dollars. Clinical data of overall response rate (ORR), progression-free survival, and overall survival were obtained from an indirect treatment comparison using MonumenTAL-1 (September 2024 data cut) and LocoMMotion/MoMMent (October 2022 and August 2023 data cuts) as data sources. Deterministic sensitivity analyses and scenario analyses were conducted to assess the robustness of model results.

RESULTS:

Over the 6-month period, the total cost of care was $179,556 for usual care, $295,993 for Tal QW, and $315,135 for Tal Q2W. Despite higher costs, Tal demonstrated superior ORR, resulting in lower cost per responder: $575,962 for usual care, $405,470 for Tal QW, and $443,165 for Tal Q2W, representing a 23-30% reduction in cost per responder with Tal. Sensitivity and scenario analyses showed consistent findings.

CONCLUSION:

Although Tal QW and Q2W are associated with higher total per-patient costs compared with usual care, they offer improved clinical effectiveness, resulting in lower cost per responder. These findings suggest greater economic value for Tal in the treatment of TCE RRMM.

01 Jun 2026·EUROPEAN JOURNAL OF HAEMATOLOGY

Salvage Therapy in Multiple Myeloma With Prior T‐Cell Engager Exposure: Talquetamab, Elranatamab or Teclistamab in Combination With Pomalidomide

Article

Author: Phull, Pooja ; Siegel, David ; Biran, Noa ; Parmar, Harsh ; Di Palma‐Grisi, James ; Vesole, David

ABSTRACT:

Multiple myeloma (MM) is a hematologic malignancy manifested by proliferation of clonal plasma cells leading to end‐organ damage. Despite significant advancements in therapeutics, it remains incurable. Cellular therapies such as chimeric antigen receptor (CAR‐T) therapy and T‐cell engager (TCE) therapies have delivered high overall response rates, but almost all patients relapse and subsequent options are limited particularly in view of the increasing prevalence of prior exposure to anti‐BCMA agents and immunomodulator (IMiD) therapies. Our retrospective review of 12 patients between January 2024 and December 2025 who received a combination of talquetamab, elranatamab, or teclistamab with pomalidomide found that 11 of 12 had an overall response, of whom 6 had very good partial response or better at median follow‐up of 9.9 months. All 12 patients were prior exposed to pomalidomide, of whom 10 had been exposed to prior CAR‐T with a median of 7 prior lines of therapy. Safety profiles were favorable: 6 patients experienced Grade 1 CRS, 7 experienced Grade III neutropenia, and 7 of 8 patients receiving talquetamab experienced on‐target, off‐tumor side effects like dysgeusia and skin dryness.

01 Jun 2026·JCO Oncology Practice

Defining the Rates of Cytokine Release Syndrome Associated With Talquetamab Step-up Doses

Article

Author: Giralt, Sergio ; Mailankody, Sham ; Shah, Gunjan L. ; Modelevsky, Lisa ; Mitchell, Aaron ; Landau, Heather J. ; Tan, Carlyn R. ; Patel, Dhwani ; Korde, Neha ; Firestone, Ross S. ; Hashmi, Hamza ; Hultcrantz, Malin L. ; Chan, Amelia ; Hamadeh, Issam S. ; Scordo, Michael ; Rajeeve, Sridevi ; Wang, Alice X. ; Shekarkhand, Tala ; Hassoun, Hani ; Lesokhin, Alexander M. ; Shah, Urvi A. ; Usmani, Saad Z. ; Maclachlan, Kylee

PURPOSE:

Talquetamab is a G protein–coupled receptor class C group 5 member D T-cell–engaging antibody, approved for relapsed/refractory multiple myeloma (RRMM). In the MonumenTAL-1 clinical trial, cytokine release syndrome (CRS) occurred at a frequency of 77%; however, there was no assessment of CRS rates by step-up dose. The primary objective of this study was to characterize CRS rates after each talquetamab step-up dose in a real-world setting.

METHODS:

Patients with RRMM who completed the talquetamab once a week or once every 2 weeks step-up dosing schedule between September 2023 and November 2024 were identified via the institutional database. CRS rate after each talquetamab step-up dose was compared using the chi-square/Fisher’s exact test. The Kruskal-Wallis test was used to compare difference in median time to the CRS onset. Multivariate logistic regression analysis was performed to identify predictors of CRS.

RESULTS:

Fifty patients completed the talquetamab step-up dosing phase during the study period; CRS occurred at a rate of 80%. Pairwise comparisons revealed significant differences in CRS rates between the fourth dose (4%) and each of step-up dose 1 (28%, P = .014) and 2 (34%, P = .003). The only CRS event with fourth dose was grade 1. The median time to onset of first CRS did not differ significantly between step-up doses ( P = .441). Previous exposure to T-cell–redirecting therapy had no impact on CRS incidence (odds ratio: 0.20 [95% CI, 0.03 to 1.10]).

CONCLUSION:

Our findings suggested that the fourth talquetamab dose could be administered in outpatient settings given its high tolerability. The reduced hospitalization period for talquetamab step-up dosing could reduce health care expenses.

158

News (Medical) associated with Talquetamab

15 Jul 2026

·www.biospace.com

Johnson & Johnson reports Q2 2026 results, raises 2026 outlook

2026 Second-Quarter reported sales growth of 6.6% to $25.3 Billion with operational growth of 5.6%* and adjusted operational growth of 5.7%* 2026 Second-Quarter earnings per share (EPS) of $2.27 and adjusted EPS* of $2.90 Strong operational performance results in the Company increasing 2026 guidance with estimated reported sales of $101.1 Billion or 7.3% at the midpoint, and increasing adjusted EPS* guidance by $0.13 to $11.68 or 8.2% at the midpoint. The adjusted operational EPS* is increasing by $0.18 to $11.58 or 7.3% at the midpoint Advancing significant innovation for patients with approvals of TREMFYA to inhibit the progression of structural joint damage in adults with active psoriatic arthritis, CAPLYTA for the prevention of relapse in schizophrenia, and Dual Energy THERMOCOOL SMARTTOUCH SF platform; fortifying future with data from RYBREVANT FASPRO in advanced head and neck cancer, TALVEY plus DARZALEX FASPRO in earlier-line relapsed or refractory multiple myeloma, and OTTAVA in upper abdominal procedures NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Johnson & Johnson (NYSE: JNJ) today announced results for second-quarter 2026. “Johnson & Johnson delivered strong second-quarter results, demonstrating the power of our innovation, the depth of our portfolio and the momentum in our pipeline as we advance transformative treatments that address the world’s toughest health challenges,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “With raised guidance and quarterly sales surpassing $25 billion, we are on track to meet our 2026 target of more than $100 billion in annual revenue for the first time in our Company’s 140-year history.” Overall financial results Q2 ($ in Millions, except EPS) 2026 2025 % Change Reported Sales $25,310 $23,743 6.6% Net Earnings $5,534 $5,537 -0.1% EPS (diluted) $2.27 $2.29 -0.9% Q2 Non-GAAP* ($ in Millions, except EPS) 2026 2025 % Change Operational Sales 1,2 5.6% Adjusted Operational Sales 1,3 5.7% Adjusted Net Earnings 1,4 $7,081 $6,699 5.7% Adjusted EPS (diluted) 1,4 $2.90 $2.77 4.7% Free Cash Flow 5,6 ~$8,700 $6,214 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Non-GAAP financial measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 6 Second-quarter YTD 2026 is estimated as of July 15, 2026 Note: values may have been rounded Regional sales results Q2 % Change ($ in Millions) 2026 2025 Reported Operational 1,2 Currency Adjusted Operational 1,3 U.S. $14,533 $13,544 7.3% 7.3 - 7.4 International 10,777 10,199 5.7 3.4 2.3 3.5 Worldwide $25,310 $23,743 6.6% 5.6 1.0 5.7 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: values may have been rounded Segment sales results ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Q2 % Change ($ in Millions) 2026 2025 Reported Operational 1,2 Currency Adjusted Operational 1,3 Innovative Medicine $16,384 $15,202 7.8% 6.8 1.0 6.9 MedTech 8,926 8,541 4.5 3.6 0.9 3.7 Worldwide $25,310 $23,743 6.6% 5.6 1.0 5.7 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: values may have been rounded Second-Quarter 2026 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales grew 6.8%*, with divestitures negatively impacting growth by 10 basis points. Growth was primarily driven by DARZALEX, CARVYKTI, TECVAYLI and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and Other Immunology in Immunology, and SPRAVATO and CAPLYTA in Neuroscience. Growth was partially offset by STELARA (an approximate 760 basis points impact) and REMICADE in Immunology, as well as IMBRUVICA and ZYTIGA in Oncology. MedTech MedTech worldwide operational sales grew 3.6%*, with net acquisitions and divestitures negatively impacting growth by 10 basis points. Growth was primarily driven by wound closure products and biosurgery products in Surgery, electrophysiology products and Shockwave in Cardiovascular, contact lenses in Vision, and trauma in Orthopaedics. Full-year 2026 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) July 2026 April 2026 Adjusted Operational Sales 1,2 Change vs. Prior Year / Mid-point 6.2% – 6.8% / 6.5% 5.6% – 6.6% / 6.1% Operational Sales 2 / Mid-point Change vs. Prior Year / Mid-point $100.3B – $100.9B / $100.6B 6.5% – 7.1% / 6.8% $99.7B – $100.7B / $100.2B 5.9% – 6.9% / 6.4% Estimated Reported Sales 3 / Mid-point Change vs. Prior Year / Mid-point $100.8B – $101.4B / $101.1B 7.0% – 7.6% / 7.3% $100.3B – $101.3B / $100.8B 6.5% – 7.5% / 7.0% Adjusted Operational EPS (Diluted) 2,4 / Mid-point Change vs. Prior Year / Mid-point $11.50 – $11.65 / $11.58 6.6% – 8.0% / 7.3% $11.30 – $11.50 / $11.40 4.7% – 6.7% / 5.7% Adjusted EPS (Diluted) 3,4 / Mid-point Change vs. Prior Year / Mid-point $11.60 – $11.75 / $11.68 7.5% – 8.9% / 8.2% $11.45 – $11.65 / $11.55 6.1% – 8.1% / 7.1% 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 2026 = $1.15 and April 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 , 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 . Regulatory Johnson & Johnson Announces FDA Approval for the Dual Energy THERMOCOOL SMARTTOUCH SF Platform 1 Press Release CHMP recommendation advances Johnson & Johnson’s TECVAYLI (teclistamab) plus daratumumab as a potential standard of care for relapsed/refractory multiple myeloma Press Release FDA approves label expansion, cementing TREMFYA as the only IL‑23 inhibitor proven to help stop further joint damage Press Release FDA approves CAPLYTA (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia Press Release Johnson & Johnson Announces CE Mark Approval for the New ETHICON 4000 Stapler Press Release FDA grants Priority Review for IMAAVY (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA) Press Release Data Releases Johnson & Johnson presents new IMAAVY (nipocalimab-aahu) data at European Academy of Neurology (EAN) 2026 Congress reinforcing sustained disease control in generalized myasthenia gravis Press Release 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 myeloma Press Release 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 Press Release Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study Press Release Johnson & Johnson presents new data further reinforcing the role of nipocalimab in lowering the autoantibodies driving Sjögren's disease Press Release RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) pivotal data show strong and durable responses in advanced head and neck cancer where options remain limited Press Release 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 paradigm Press Release RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) demonstrates prolonged clinical benefit as a first-line treatment for atypical EGFR-mutated non-small cell lung cancer Press Release New TECVAYLI (teclistamab-cqyv) data demonstrate superior progression-free and overall survival as early as first relapse in multiple myeloma Press Release Johnson & Johnson study shows TREMFYA (guselkumab) is the first and only IL-23 inhibitor to demonstrate efficacy in perianal fistulizing Crohn's disease Press Release Johnson & Johnson investigational co-antibody therapy JNJ-4804 shows potential to raise the bar for clinical efficacy in treating refractory inflammatory bowel disease Press Release Johnson & Johnson Announces Pivotal Clinical Study Results for a New Soft-Tissue Surgical Robotic System Press Release CAPLYTA (lumateperone) showed greatest improvement across key efficacy outcomes among adjunctive MDD treatments in new network meta-analysis Press Release IMAAVY (nipocalimab-aahu) shows over two years of sustained disease control in a broad population with generalized myasthenia gravis (gMG) Press Release Product Launch Johnson & Johnson Advances the Standard of Calcium Modification with Global Launch of Shockwave C2 Aero Coronary IVL Catheter Press Release Other DePuy Synthes Appoints Christina Zamarro as Chief Financial Officer 1 Press Release Johnson & Johnson Invests more than $1 Billion to Strengthen U.S. Vision Manufacturing in Jacksonville, Florida Press Release Johnson & Johnson Expands U.S. Availability of TECNIS PureSee IOL, an Advanced Lens Option for Cataract Surgeons and Patients Press Release Johnson & Johnson to Acquire Firefly Bio, Inc. to Expand Oncology Pipeline with Novel Degrader Antibody Conjugate Platform Press Release DePuy Synthes Announces Agreement to Acquire Miniature Radiofrequency Tracking Technology Across its Joint Reconstruction Portfolio Press Release DePuy Synthes Enters Exclusive U.S., Canada and Australia Distribution Agreement for CGBIO’s NOVOSIS Press Release Groundbreaking global survey captures the significant patient burden experienced with current standard-of-care bladder cancer treatments, underscoring urgency for continued innovation Press Release Johnson & Johnson Appoints Ryan Koors as Vice President, Investor Relations Press Release Johnson & Johnson Launches Landmark Head-to-Head Pulsed Field Ablation Trial in Persistent Atrial Fibrillation Press Release Johnson & Johnson Showcases CARTO-Powered Innovation, Including Debut of CARTOSOUND SONATA, to Advance Arrhythmia Care at HRS 2026 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 . 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 , , 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) SECOND QUARTER SIX MONTHS Percent Change Percent Change 2026 2025 Total Operations Currency 2026 2025 Total Operations Currency Sales to customers by segment of business Innovative Medicine U.S. $ 9,979 9,161 8.9 % 8.9 - $ 18,850 17,253 9.3 % 9.3 - International 6,405 6,041 6.0 3.6 2.4 12,960 11,822 9.6 3.9 5.7 16,384 15,202 7.8 6.8 1.0 31,810 29,075 9.4 7.1 2.3 MedTech U.S. 4,554 4,383 3.9 3.9 - 9,013 8,596 4.8 4.8 - International 4,372 4,158 5.2 3.2 2.0 8,549 7,965 7.3 3.2 4.1 8,926 8,541 4.5 3.6 0.9 17,562 16,561 6.0 4.1 1.9 U.S. 14,533 13,544 7.3 7.3 - 27,863 25,849 7.8 7.8 - International 10,777 10,199 5.7 3.4 2.3 21,509 19,787 8.7 3.6 5.1 Worldwide $ 25,310 23,743 6.6 % 5.6 1.0 $ 49,372 45,636 8.2 % 6.0 2.2 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) SECOND QUARTER SIX MONTHS Percent Change Percent Change 2026 2025 Total Operational Currency 2026 2025 Total Operational Currency Sales to customers by geographic area U.S. $ 14,533 13,544 7.3 % 7.3 - $ 27,863 25,849 7.8 % 7.8 - Europe 5,726 5,387 6.3 3.3 3.0 11,574 10,497 10.3 3.0 7.3 Western Hemisphere excluding U.S. 1,309 1,206 8.5 2.7 5.8 2,602 2,373 9.6 2.6 7.0 Asia-Pacific, Africa 3,742 3,606 3.8 3.9 (0.1) 7,333 6,917 6.0 4.9 1.1 International 10,777 10,199 5.7 3.4 2.3 21,509 19,787 8.7 3.6 5.1 Worldwide $ 25,310 23,743 6.6 % 5.6 1.0 $ 49,372 45,636 8.2 % 6.0 2.2 Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. Johnson & Johnson and Subsidiaries Condensed Consolidated Statement of Earnings (Unaudited; in Millions Except Per Share Figures) SECOND QUARTER 2026 2025 Percent Increase (Decrease) Amount Percent to Sales Amount Percent to Sales Sales to customers $ 25,310 100.0 $ 23,743 100.0 6.6 Cost of products sold 8,051 31.8 7,628 32.1 5.5 Gross Profit 17,259 68.2 16,115 67.9 7.1 Selling, marketing and administrative expenses 6,432 25.4 5,889 24.8 9.2 Research and development expense 3,653 14.4 3,516 14.8 3.9 Interest (income) expense, net 62 0.2 48 0.2 Other (income) expense, net 331 1.3 107 0.5 Restructuring 34 0.2 64 0.3 Earnings before provision for taxes on income 6,747 26.7 6,491 27.3 3.9 Provision for taxes on income 1,213 4.8 954 4.0 27.1 Net earnings $ 5,534 21.9 $ 5,537 23.3 (0.1 ) Net earnings per share (Diluted) $ 2.27 $ 2.29 (0.9 ) Average shares outstanding (Diluted) 2,440.1 2,419.1 Effective tax rate 18.0 % 14.7 % Adjusted earnings before provision for taxes and net earnings (1) Earnings before provision for taxes on income $ 8,660 34.2 $ 8,188 34.5 5.8 Net earnings $ 7,081 28.0 $ 6,699 28.2 5.7 Net earnings per share (Diluted) $ 2.90 $ 2.77 4.7 Effective tax rate 18.2 % 18.2 % (1) See Reconciliation of Non-GAAP Financial Measures. Johnson & Johnson and Subsidiaries Condensed Consolidated Statement of Earnings (Unaudited; in Millions Except Per Share Figures) SIX MONTHS 2026 2025 Percent Increase (Decrease) Amount Percent to Sales Amount Percent to Sales Sales to customers $ 49,372 100.0 $ 45,636 100.0 8.2 Cost of products sold 16,157 32.7 14,985 32.8 7.8 Gross Profit 33,215 67.3 30,651 67.2 8.4 Selling, marketing and administrative expenses 12,466 25.3 11,001 24.1 13.3 Research and development expense 7,180 14.5 6,741 14.8 6.5 In-process research and development impairments 36 0.1 - - Interest (income) expense, net 105 0.2 (80 ) (0.2 ) Other (income) expense, net 625 1.3 (7,214 ) (15.8 ) Restructuring 66 0.1 81 0.2 Earnings before provision for taxes on income 12,737 25.8 20,122 44.1 (36.7 ) Provision for taxes on income 1,968 4.0 3,586 7.9 (45.1 ) Net earnings $ 10,769 21.8 $ 16,536 36.2 (34.9 ) Net earnings per share (Diluted) $ 4.41 $ 6.82 (35.3 ) Average shares outstanding (Diluted) 2,443.9 2,423.3 Effective tax rate 15.5 % 17.8 % Adjusted earnings before provision for taxes and net earnings (1) Earnings before provision for taxes on income $ 16,481 33.4 $ 16,199 35.5 1.7 Net earnings $ 13,695 27.7 $ 13,405 29.4 2.2 Net earnings per share (Diluted) $ 5.60 $ 5.53 1.3 Effective tax rate 16.9 % 17.2 % (1) See Reconciliation of Non-GAAP Financial Measures. Johnson & Johnson and Subsidiaries Reconciliation of Non-GAAP Financial Measures Second Quarter Six Months Ended (Dollars in Millions Except Per Share Data) 2026 2025 2026 2025 Net Earnings, after tax- as reported $5,534 $5,537 $10,769 $16,536 Pre-tax Adjustments Litigation related 267 57 597 (6,909 ) Intangible Asset Amortization expense 1,245 1,267 2,492 2,387 Restructuring related 1 276 79 338 134 Orthopaedics separation related 258 - 377 - Acquisition, integration and divestiture related 80 246 176 378 (Gains)/losses on securities (213 ) 21 (272 ) 60 IPR&D impairments - - 36 - Other - 27 - 27 Tax Adjustments Tax impact on special item adjustments 2 (368 ) (321 ) (792 ) 994 Tax legislation and other tax related 2 (214 ) (26 ) (202 ) Adjusted Net Earnings, after tax $7,081 $6,699 $13,695 $13,405 Average shares outstanding (Diluted) 2,440.1 2,419.1 2,443.9 2,423.3 Adjusted net earnings per share (Diluted) $2.90 $2.77 $5.60 $5.53 Operational adjusted net earnings per share (Diluted) $2.86 $5.43 Notes: 1 In the fiscal second quarter of 2026, the Company commenced a supply chain restructuring program primarily in the Innovative Medicine segment to exit certain manufacturing locations as part of its optimization efforts to streamline operations. The program is expected to be substantially completed by the end of fiscal year 2029 with estimated costs between $650 - $750 million, and include site and supplier exit costs, decommissioning and asset impairment costs. Restructuring expenses of $200 million, primarily related to asset impairments, were recorded in the fiscal second quarter of 2026. 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. Restructuring expenses of $59 million were recorded in the fiscal second quarter of 2026 ($114 million Q2 2026 YTD) and $29 million in the fiscal second quarter of 2025 ($29 million Q2 2025 YTD) and primarily include costs related to product exits. This program is expected to be substantially completed by the end of fiscal year 2026. 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 expenses of $17 million in the fiscal second quarter of 2026 ($24 million Q2 2026 YTD) and $50 million in the fiscal second quarter of 2025 ($105 million Q2 2025 YTD) includes costs related to market and product exits. This program will be completed as of Q4 2026 at a total cost of approximately $1 billion. 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. Contacts Media contact: media-relations@its.jnj.com Investor contact: investor-relations@its.jnj.com Read full story here

Clinical ResultDrug ApprovalPhase 2Phase 3Financial Statement

13 Jul 2026

·www.biospace.com

Fate Therapeutics Receives FDA Clearance of Investigational New Drug Application for FT839 Product Candidate

First-of-Kind, Dual-CAR T cell Targeting CD19 and CD38 for Comprehensive Elimination of Complex, Multi-System Autoimmune Disorders Advances into Phase 1/2 Clinical Development Novel 13-point edited CAR T cell Built with a Suite of Genetic Edits and Manufactured as a Uniform Drug Product to Support Clinical Safety and Durable Efficacy in Autoimmune and Hematological Malignancies SAN DIEGO, July 09, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies broadly to patients with cancer and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for FT839, the Company’s next-generation, off-the-shelf CAR T-cell product candidate uniquely engineered to co-target CD19 and CD38. With IND clearance, the Company plans to advance FT839 into a basket clinical trial intended to evaluate the product candidate across a range of autoimmune diseases when administered in combination with standard-of-care therapy and without dependence on conditioning chemotherapy. Enrollment in the Phase 1/2 study is expected to commence in the second half of 2026. “FDA clearance of the FT839 IND is an important milestone that expands our off-the-shelf, iPSC-derived CAR T-cell platform capabilities for the comprehensive treatment of autoimmune disease, including rheumatoid arthritis,” said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. “By co-targeting CD19 and CD38, FT839 is uniquely engineered to eliminate the full spectrum of aberrant, disease-driving immune cells, including B cells, plasma cells, and activated T cells, that are often the foundation of multicellular disease found in many autoimmune disorders as well as in hematological malignancies. In addition to the incorporation of multiple genetic edits to enhance performance and safety of the drug product, FT839 also includes our patented Sword & Shield™ technology which is designed to support durable activity without dependence on conditioning chemotherapy. The remarkably homogenous pro FT839, a 13-point edited CAR T cell, is a testament to our distinct ability to genetically engineer cells and is enabled by our iPSC master cell bank platform where we have pioneered the ability to manufacture multiplex-engineered CAR T cells in a uniform and consistent manner at large scale for on-demand availability. We look forward to initiating the basket portion of this exciting Phase 1/2 study across multiple autoimmune indications and to advancing a truly accessible treatment option for patients in need.” FT839 is the Company’s second CAR T-cell product candidate to advance into clinical development for autoimmune disease, joining FT819, an off-the-shelf, CD19-targeted CAR T-cell candidate currently entering Phase 2 development in a potentially registrational trial in lupus nephritis. FT839 is designed to broaden the reach of off-the-shelf CAR T-cell therapy beyond B-cell depletion by simultaneously targeting CD19 and CD38. The elimination of B-lineage cells, including plasma cells, and CD38-expressing activated and proliferating immune cells (e.g. T cells, macrophages and NK cells) is expected to support comprehensive immune rebalancing across a diverse spectrum of autoimmune conditions. FT839 immune cell targeting can be further extended in combination with approved therapeutic monoclonal antibodies or T-cell engagers. Additionally, the Phase 1/2 trial design allows for accelerated development opportunities by avoiding the gap between separate Phase 1 and Phase 2 trials and is intended to enable assessment of both safety and efficacy data in a single trial. FT839 has been engineered with 13 targeted genetic edits that together confer multi-antigen targeting, immune evasion, and enhanced functional persistence, and that are designed to overcome key limitations of autologous patient-derived and allogeneic donor-derived CAR T-cell therapy, including manufacturing complexity, high cost, limited on-demand availability, and the requirement for intensive conditioning chemotherapy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master iPSC bank serves as the starting cell source to manufacture FT839, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT839 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. FT839 multiplexed engineering includes the following functional elements: Dual CD19 and CD38 chimeric antigen receptors (CARs) to eliminate aberrant and pathogenic immune cells such as B cells, plasma cells, macrophages and activated T cells, as well as hematologic cancer cells of lymphoma, leukemia, and myeloma origin. High-affinity, non-cleavable CD16 (hnCD16) Fc receptor to maximize antibody-dependent cellular cytotoxicity (ADCC) in combination with approved therapeutic monoclonal antibodies (for example, rituximab or obinutuzumab), extending coverage against antigen-heterogeneous and antigen-escape populations. CD3ε Fusion Receptor (CD3FR) to support T-cell engager (TCE)–driven activation in combination with approved bispecific engagers (for example, epcoritamab, teclistamab or talquetamab). Sword & Shield™ technology (comprising an Alloimmune Defense Receptor and a CD58 genetic knockout) to selectively eliminate and evade host allogeneic immune responses, promote functional persistence, and thereby avoid the need for conditioning chemotherapy. Synthetic chemokine receptor CXCR2 and a TGFβ signal redirection receptor (TGFβ SRR) to improve trafficking to sites of pathological activity and to counter the immunosuppressive effects of the tissue microenvironment. CD38 and TRAC genetic knockouts to enhance metabolic fitness and safety pro avoiding the risk of graft versus host disease in allogeneic setting, respectively. In preclinical studies, including data presented at the 2026 American Society of Gene and Cell Therapy (ASGCT) and at the European Congress of Rheumatology (EULAR) Annual Meetings, FT839 selectively eliminated autoimmune disease drivers such as B cells, plasma cells, and activated T cells, as well as hematologic cancer cells, both as monotherapy through its dual CARs and in combination with therapeutic monoclonal antibodies and T-cell engagers. In allogeneic settings, Sword & Shield™ technology supported enhanced persistence and durable activity of FT839 without conditioning chemotherapy. The Phase 1/2 study consists of a multi-indication basket trial designed to evaluate the safety, tolerability, and preliminary activity of FT839 administered in combination with standard-of-care therapy, with or without the use of conditioning chemotherapy, in patients with autoimmune disease. The initial autoimmune indications to be evaluated in the trial are: Rheumatoid arthritis, ANCA-associated vasculitis, Idiopathic inflammatory myositis, Systemic lupus erythematosus with or without nephritis, and Systemic sclerosis. The company also plans to investigate the activity of FT839 in other autoimmune diseases, including Type 1 diabetes and multiple sclerosis, through investigator-initiated trials. Beyond autoimmune disease, the Company believes the dual-CAR mechanism of FT839 and ability to combine with therapeutic monoclonal antibodies and T-cell engagers also support its potential in hematologic malignancies, including B-cell lymphomas, leukemias, and multiple myeloma. About FT839 FT839 is the Company’s first multi-antigen dual-CAR T-cell product candidate that is designed to express two unique CARs: a first CAR targeting the B-cell lineage marker CD19 and the second CAR targeting the immune activation marker CD38, which is often found on aberrant T, NK and B cells. FT839 is the second product candidate to contain the Company’s Sword and Shield TM technology. At the 2025 ASH Annual Meeting, the Company presented preclinical data demonstrating the ability of FT839, with its dual-CAR mechanism and unique ability to synergize with monoclonal antibodies and T-cell engagers through its incorporated hnCD16 Fc receptor and CD3 fusion receptor, respectively, to specifically eliminate a variety of pathogenic immune cell types without requiring conditioning chemotherapy, suggesting its potential to broadly treat complex autoimmune diseases and hematologic malignancies. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company's product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, including the Company’s plans to complete IND-enabling activities and submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials and the Company’s plans to provide updates on its clinical trials, the clinical, therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, and the Company’s progress and plans relating to, and the anticipated timing and outcome of, interactions with the FDA and other regulatory authorities, including its expectations relating to alignment with regulatory authorities on potential registrational pathways for FT839 and FT819. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and risks relating to regulatory interactions and the outcome of such interactions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise. Ryan Douglas Fate Therapeutics, Inc. IR@fatetherapeutics.com

ImmunotherapyCell TherapyIND

26 Jun 2026

·www.biospace.com

CHMP recommendation advances Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab as a potential standard of care for relapsed/refractory multiple myeloma

Recommendation supported by unprecedented Phase 3 data, demonstrating that TECVAYLI ® in combination with daratumumab achieved statistically significant improvements in progression-free and overall survival versus standard of care 1 Pending approval, this novel complementary immunotherapy combination is positioned to delay disease progression for patients treated as early as second line, with 83% of patients alive at three years 1 BEERSE, BELGIUM, June 26, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication extension of TECVAYLI ® (teclistamab) in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. Advancing complementary immunotherapies to improve patient outcomes Teclistamab and daratumumab work in a mechanistically complementary manner by engaging multiple tumour and immune directed pathways. 1,2 When combined, daratumumab modulates the immune system to create a more favourable immune microenvironment and enhances T-cell fitness and activation, amplifying teclistamab-mediated killing of myeloma cells. 1,2 This combination improves patient outcomes by using immunotherapies earlier in the treatment journey when patients’ immune systems are more robust. 1, 2 Expert and company perspectives support the earlier use of teclistamab combination in multiple myeloma care “Unprecedented data show a meaningful extension in overall survival and minimal progression events observed after the first six months. More than 90% of patients receiving the combination who were progression-free at six months remained progression-free at three years, highlighting the potential for durable long-term disease control.” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “This CHMP opinion marks an important step towards establishing the off-the-shelf immunotherapy combination of teclistamab plus daratumumab as a new standard of care earlier in the treatment pathway for multiple myeloma.” “At Johnson & Johnson our ambition is to leverage the full potential of our comprehensive multiple myeloma portfolio, to strengthen patient outcomes at every stage of the treatment continuum,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "By advancing innovative immunotherapies such as teclistamab and combining them with a well-established standard of care like daratumumab, we are building on our deep scientific expertise to deliver more integrated, combination-based approaches that can continue to raise expectations for patient care.” Teclistamab plus daratumumab SC achieves meaningful and sustained improvements in patient outcomes The CHMP recommendation is supported by data from the Phase 3 MajesTEC-3 study ( NCT05083169 ), evaluating the efficacy and safety of teclistamab plus daratumumab subcutaneous (SC) formulation versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients who have received 1–3 prior lines of therapy. 3 At nearly three years of follow-up, results show an 83.4% reduction in the risk of disease progression or death in patients treated with teclistamab plus daratumumab SC, compared to standard of care (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12-0.23; p <0.0001). 1 More than 90% of patients who remained progression-free at six months (n=249) remained progression-free at three years, demonstrating sustained disease control over time. 1 Overall survival (OS) favoured teclistamab plus daratumumab SC (HR, 0.46; 95% CI, 0.32-0.65; p <0.0001), with treatment benefit observed across all prespecified subgroups. 1 ,2 At three years, OS rates were 83.3% for the combination and 65.0% for standard of care. 1 Both progression-free survival and OS benefits were clinically meaningful and statistically significant. 1 Manageable safety pro with teclistamab combination Teclistamab plus daratumumab SC demonstrated a safety pro with the well-known profiles of the individual therapies. 1 , 3 , 4 All cases of cytokine release syndrome were Grade 1/2, did not lead to treatment discontinuation, and were manageable and resolved. 1 Rates of Grade 3/4 treatment-emergent adverse events (TEAEs) were comparable to standard of care regimens (95.1% vs. 96.6%) with cytopenia and infection most commonly observed. 1 Grade ≥3 infections decreased over time with the use of immunoglobulin supplementation and infection prophylaxis, along with a switch to monthly dosing. 2 Discontinuations due to TEAEs were low and similar between study arms (4.6% vs. 5.5%). 1 About the MajesTEC-3 Study MajesTEC-3 ( NCT05083169 ) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab plus daratumumab subcutaneous (SC) (n=291) versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (n=296) (DPd/DVd) in patients with relapsed or refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy. 5 The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD) negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety. 5 The MajesTEC-3 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen. 5 About Teclistamab Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. 6 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. 7 Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody. 3 , 8 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer. 1,3 Teclistamab is currently being evaluated in several combination studies. 5 , 9,10 ,11 To date, more than 26,000 patients have been treated worldwide with teclistamab. 1 2 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: . ▼ In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring. 3 About Daratumumab and Daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012 , Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 748,000 patients worldwide. 1 3 Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. 5, 1 4 Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training. 5, 15 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE ® drug delivery technology. 5 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. 5 ,16 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death. 5 Daratumumab may also have an effect on normal cells. 5 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 17,18,19,20,21,22,23,24,25,26 For further information on daratumumab, please see the Summary of Product Characteristics at: . 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 7 ,2 8 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications. 2 9 , 30 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died. 31 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter. 32 , 33 ,3 4 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage. 3 5 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 . Follow us at . 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 teclistamab and daratumumab. 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 materialise, 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; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour 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 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. Key Search Terms MajesTEC-3 Phase 3 clinical trial TECVAYLI Teclistamab DARZALEX Daratumumab Teclistamab and daratumumab combination TECVAYLI and DARZALEX combination Relapsed and or refractory multiple myeloma (RRMM) Early relapse multiple myeloma Second line multiple myeloma treatment First relapse therapy for multiple myeloma Treatment resistance in multiple myeloma Progression-free survival (PFS) in multiple myeloma Overall survival (OS) in multiple myeloma Multiple myeloma Bispecific antibody therapy CD38-targeted therapy BCMA-targeted bispecific therapy Combination immunotherapy EMEA haematology pipeline Multiple myeloma innovation Multiple myeloma treatment END References: 1 Costa L, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2026;394(8):739-752. 2 Mateos MV, et al. Phase 3 Randomized Study of Teclistamab plus Daratumumab Versus Investigator’s Choice of Daratumumab and Dexamethasone with either Pomalidomide or Bortezomib (DPd/DVd) in patients (pts) with Relapsed Refractory Multiple Myeloma (RRMM): Results of the MajesTEC-3 Study. Oral Presentation #06. American Society of Hematology (ASH) Annual Meeting; 06-09 December, 2025. 3 European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: . Last accessed: June 2026. 4 European Medicines Agency. DARZALEX Summary of Product Characteristics. Available at: . Last accessed: June 2026. 5 ClinicalTrials.gov. A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3). Available at: . Last accessed: June 2026. 6 Johnson & Johnson.com. Janssen Marks First Approval Worldwide for TECVAYLI®▼(teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma. Available at: . Last accessed: June 2026. 7 Johnson & Johnson.com. European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab). Available at: . Last accessed: June 2026. 8 Moreau P, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022;287(6):494-505. 9 ClinicalTrials.gov. A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: . Last accessed: June 2026. 10 ClinicalTrials.gov. A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: . Last accessed: June 2026. 11 ClinicalTrials.gov. A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma. Available at: . Last accessed: June 2026. 12 J&J Data on File. Number of Patients Treated with TECVAYLI Worldwide as of March 2026. 13 J&J Data on File. Number of Patients Treated with DARZALEX ® Worldwide as of December 2025. 14 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX ® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: . Last accessed: June 2026. 15 J&J Data on File. DARZALEX® is the first oncology injectable approved for self-administration by patients or caregivers as of March 2026. 16 Fedele G, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNy cytokines and proliferation. Mediators Inflamm. 2013;564687. 17 Moreau P, et al. Bortezomib, Thalidomide, and Dexamethasone With or Without Daratumumab Before and After Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma (CASSIOPEIA): A Randomised, Open-label, Phase 3 Study. Lancet. 2019;394(10192):29-38. 18 Facon T, et al. MAIA Trial Investigators. Daratumumab Plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019;380(22):2104-2115. 19 Mateos MV, et al. Overall Survival with Daratumumab, Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma (ALCYONE): A Randomised, Open-label, Phase 3 Trial. The Lancet. 2020;395(10218):132-141. 20 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab Plus Pomalidomide and Dexamethasone Versus Pomalidomide and Dexamethasone Alone in Previously Treated Multiple Myeloma (APOLLO): An Open-label, Randomised, Phase 3 Trial. Lancet Oncol. 2021;22(6):801-812. 21 Palladini G, et al. Daratumumab Plus CyBorD for Patients with Newly Diagnosed AL Amyloidosis: Safety Run-in Results of ANDROMEDA. Blood. 2020;2;136(1):71-80. 22 Chari A, et al. Daratumumab Plus Pomalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma. Blood. 2017;130(8):974-981. 23 Bahlis NJ, et al. Daratumumab Plus Lenalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Extended Follow-up of POLLUX, A Randomized, Open-label, Phase 3 study. Leukemia. 2020;34(7):1875-1884. 24 Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma: Three-Year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk. 2020;20(8):509-518. 25 Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients with Transplant-Ineligible or Transplant-Deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral Presentation. 21 st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024. 26 Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024; 390(4):301-313. 27 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207. 28 Myeloma UK. What is myeloma? Available at: . Last accessed: June 2026. 29 Lungu O, et al. Mechanistic insights into bone destruction in multiple myeloma: cellular and molecular perspectives. Journal of Bone Oncology. 2025;51:100668. 30 Mayo Clinic. Multiple Myeloma. Available at: . Last accessed: June 2026. 31 ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2022, by Country. Multiple Myeloma. Available at: . Last accessed: June 2026. 32 Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347. 33 Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23. 34 McCurdy A, et al. Redefining attrition in multiple myeloma (MM): a Canadian myeloma research group (CMRG) analysis. Blood Cancer Journal. 2023;13(1):111. 35 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: . Last accessed: June 2026. CP-583164 June 2026 CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investor contact: Jess Margevich investor-relations@its.jnj.com

Clinical ResultPhase 3Drug ApprovalLicense out/inImmunotherapy

100 Deals associated with Talquetamab

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Refractory Multiple Myeloma	Japan	Janssen Pharmaceutical KK	24 Jun 2025
Relapse multiple myeloma	Japan	Janssen Pharmaceutical KK	24 Jun 2025
Multiple Myeloma	United States	Janssen Biotech, Inc.	09 Aug 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Multiple Myeloma	Phase 2	United States	Janssen Research & Development LLC	01 Aug 2026
Recurrent Multiple Myeloma	Phase 2	United States	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Aug 2026
Residual Neoplasm	Phase 2	United States	Johnson & Johnson	21 Aug 2025
Peripheral Stem Cell Transplantation	Phase 2	United States	Janssen Scientific Affairs LLC	05 Jun 2025
Smoldering Multiple Myeloma	Phase 2	United States	Janssen Scientific Affairs LLC	04 Dec 2023
Extramedullary Disease in Multiple Myeloma	Phase 2	Spain	Janssen Pharmaceutica NV	21 Sep 2023
Hematologic Neoplasms	Phase 1	United States	Janssen Research & Development LLC	16 Dec 2017
Hematologic Neoplasms	Phase 1	Belgium	Janssen Research & Development LLC	16 Dec 2017
Hematologic Neoplasms	Phase 1	Netherlands	Janssen Research & Development LLC	16 Dec 2017
Hematologic Neoplasms	Phase 1	Spain	Janssen Research & Development LLC	16 Dec 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05455320 (MonumenTAL-3, Pubmed \| N Engl J Med)	Phase 3	-	864	Talquetamab-Daratumumab-Pomalidomide	gokehpzwpx(vlvcqnahor) = uqxobfyynu nsaovwqtsf (lagzvrdimp ) View more	Positive	13 Jun 2026
				Talquetamab-Daratumumab	gokehpzwpx(vlvcqnahor) = psdogacror nsaovwqtsf (lagzvrdimp ) View more
ASCO2026	Not Applicable	Refractory Multiple Myeloma	1,941	Talquetamab	amueusmxqo(eehqpijfsy) = TQ group had higher risk for developing CRS (RR 1.91 (1.34, 2.72), p<0.0001) uwkayqcpez (ujxcdrhzqb ) View more	Positive	29 May 2026
				Teclistamab
ASCO2026	Not Applicable	Relapse multiple myeloma	590	Talquetamab	khekxzraxk(qiokpkhpby) = ER visits (HR = 0.716), anemia (HR = 0.915), sepsis (HR = 0.803), and pneumonia (HR = 0.641) were numerically lower in the talquetamab group but were not statistically significant (p > 0.05). Neutropenia (HR = 1.082), thrombocytopenia (HR = 1.301), and CRS (HR = 1.617) did not differ significantly (p > 0.05). Hospitalization, MM relapse, and neurotoxicity were not analyzable due to low events. xxamphdqtq (lygcdpienz ) View more	Positive	29 May 2026
				Sequential BDT
ASCO2026	Not Applicable	Relapse multiple myeloma	402	Talquetamab	sxslakethb(cpzytmpajq) = dkcbbnfqup qmqhlgwynh (enpdouxmyn ) View more	Positive	29 May 2026
				Teclistamab	sxslakethb(cpzytmpajq) = avquxajjkh qmqhlgwynh (enpdouxmyn ) View more
ASCO2026	Not Applicable	Multiple Myeloma	542	Talquetamab+IVIG	khrowtvqah(shxvmzzfvk) = ptylrwmgqq cqvkdutdmo (wovqshgjvz ) View more	Positive	29 May 2026
				Talquetamab	khrowtvqah(shxvmzzfvk) = dhzxsbmcdz cqvkdutdmo (wovqshgjvz ) View more
ASCO2026	Not Applicable	Refractory Multiple Myeloma	78	Talquetamab	prtplbncle(jhvxfksryt) = uzvwlomnfe wnnhlmlamr (xzkkatummc, 0.27 - 0.4) View more	Positive	29 May 2026
				Elranatamab	prtplbncle(jhvxfksryt) = otzoymtmlj wnnhlmlamr (xzkkatummc, 0.19 - 0.49) View more
ASCO2026	Not Applicable	Multiple Myeloma BCMA	7,280	Ide-cel	xnkodkfcwm(thfqdaypus) = fdaofwmtfn fxfyvmyyhz (bzdqzlebgl ) View more	Negative	29 May 2026
				Cilta-cel	xnkodkfcwm(thfqdaypus) = osenpjtiyz fxfyvmyyhz (bzdqzlebgl ) View more
NCT04586426 (RedirecTT-1, ASCO2026)	Phase 1/2	Relapse multiple myeloma	114	Talquetamab 0.8 mg/kg + Teclistamab 1.5 mg/kg Q2W	prfrilcwpt(tdafysrplw) = cljqtwrzkn yhlldupdbo (lexckrheqs ) View more	Positive	29 May 2026
				Talquetamab 0.8 mg/kg + Teclistamab 3.0 mg/kg	prfrilcwpt(tdafysrplw) = dzvozkubmz yhlldupdbo (lexckrheqs ) View more
NCT05972135 (ASCO2026)	Phase 2	Relapse multiple myeloma	50	TocilizumabTeclistamab + TocilizumabTeclistamab	vgnhgvwmzr(vdsnkdsnhi) = tjiepwrkao tnsfgkgfzd (oqrnpsttaj ) View more	Positive	29 May 2026
				TocilizumabTalquetamab + TocilizumabTalquetamab	vgnhgvwmzr(vdsnkdsnhi) = vnnryenbmz tnsfgkgfzd (oqrnpsttaj ) View more
NCT05455320 (MonumenTAL-3, EHA2026)	Phase 3	Relapse multiple myeloma Second line	864	Talquetamab+DARATUMUMAB+Pomalidomide	spsuwonzmu(yvhrbuuibu) = vjziypqeru hbvqtyxbwg (asawhmvxlr, 75.8 - 85.7) View more	Positive	12 May 2026
				Talquetamab+DARATUMUMAB	spsuwonzmu(yvhrbuuibu) = bzuytnxcnu hbvqtyxbwg (asawhmvxlr, 71.7 - 82.5) View more

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