Category: 3. Business

  • Upstart’s stock extends declines as the AI lender predicts slower growth

    Upstart’s stock extends declines as the AI lender predicts slower growth

    By Emily Bary

    Upstart’s December-quarter revenue is expected to slow more than Wall Street had been modeling

    Upstart saw 80% growth in loan originations during the September quarter.

    Lending company Upstart Holdings expects its growth to slow going forward – and by more than Wall Street was expecting.

    Shares of the financial-technology company, which uses AI to inform lending decisions, were off 16% in Tuesday’s extended trading following downbeat guidance for the December quarter. Upstart’s (UPST) management is targeting $288 million in revenue, up 32% from a year before, while the FactSet consensus was for $304 billion.

    That would also mark a dramatic slowdown from the 71% growth rate seen in the September quarter, which resulted in $277 billion in revenue, versus the $280 billion consensus view.

    The after-hours stock slide would be on top of to a 25% year-to-date decline sustained through the regular-session close.

    See more: SoFi’s business is on fire, and these earnings numbers show what’s clicking

    “Our AI platform is performing exactly as designed, rapidly adapting to evolving macro signals while delivering strong results,” CEO Dave Girouard said in a release.

    Upstart grew loan originations at a faster rate -80% – than it did revenue, and Girouard called out “a sixfold sequential increase” in net income on a GAAP basis.

    On Upstart’s earnings call, he said that “the opportunity for AI in credit is unimaginably large, and there’s no one better positioned than Upstart to lead this trillion-dollar industry to this exciting and inevitable direction.”

    He also said Upstart’s underwriting models have responded well to fluctuations in industry conditions, but overall he’s seen stable trends among the company’s customer base.

    Girouard said he has seen “no material deterioration in consumer credit strength” – and better yet, “recent signs of improvement.”

    Upstart’s management seemed to push back on the notion of a K-shaped economy that is said to benefit upper-income consumers as lower-income individuals have struggled, and that an analyst recently said has helped lending rival SoFi Technologies (SOFI).

    Those with sub-660 credit scores, according to Upstart’s earnings-call commentary, are in decent shape relative to pre-COVID default trends, and those with 800-plus credit scores are “doing very well.” But default rates are “quite elevated” for consumers with credit scores in the “720 to 750” range. That suggests more of a U-shape, the company said.

    Shares of Upstart often take big swings after earnings: Prior to this latest report, eight of the past 10 post-earnings moves have been by a double-digit rate.

    Don’t miss: Fiserv’s outlook reset is deemed ‘difficult to comprehend’

    -Emily Bary

    This content was created by MarketWatch, which is operated by Dow Jones & Co. MarketWatch is published independently from Dow Jones Newswires and The Wall Street Journal.

    (END) Dow Jones Newswires

    11-04-25 1828ET

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  • Eversource Energy beats third quarter profit estimates on higher power rates – Reuters

    1. Eversource Energy beats third quarter profit estimates on higher power rates  Reuters
    2. Eversource Energy Reports Third Quarter 2025 Results  Yahoo Finance
    3. Eversource: Q3 Earnings Snapshot  San Francisco Chronicle
    4. Eversource Energy earnings beat by $0.03, revenue fell short of estimates  Investing.com
    5. Eversource Energy Reports Strong Q3 2025 Earnings  TipRanks

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  • Brazil’s Itau hikes net interest income outlook, posts in line recurring profit

    Brazil’s Itau hikes net interest income outlook, posts in line recurring profit

    SAO PAULO, Nov 4 (Reuters) – Brazilian lender Itau Unibanco on Tuesday reported third-quarter net recurring profit in line with analysts’ estimates and raised its projection for 2025 net interest income with the market.

    Itau, Latin America’s largest private lender by total assets, reported an 11.9 billion reais ($2.20 billion) net recurring profit for the July-September period, matching the expectations of analysts polled by LSEG.

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    Returns on equity stood at 23.3%, increasing 0.6 percentage points from the same period a year earlier, but stable from the previous quarter.

    The lender revised up its yearly projection for net interest income with the market to between 3 billion reais ($555.2 million) and 3.5 billion reais ($647.7 million), from a previous estimate of between 1 billion and 3 billion reais.

    “This revision mostly reflects the more positive dynamics of the trading desk accumulated results compared to the original expectation,” Itau said, adding that all other 2025 projections remain unchanged.

    Itau’s total credit portfolio reached 1.4 trillion reais at the end of September, up 6.4% year-on-year.

    ($1 = 5.4039 reais)

    Reporting by Andre Romani and Paula Arend Laier , Editing by Natalia Siniawski

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  • Amgen profit beats estimates, weight-loss data due by year-end – Reuters

    1. Amgen profit beats estimates, weight-loss data due by year-end  Reuters
    2. Amgen Crushes Third-Quarter Expectations On The Back Of Two Blockbusters  Investor’s Business Daily
    3. Amgen Inc. (AMGN) Stock: Surge as 12% Revenue and Strong Cash Flow Attracts Investor Attention  CoinCentral
    4. Amgen Q3 earnings on deck: Here’s what to expect  MSN
    5. PREVIEW: Amgen seen posting 10% year-on-year EPS drop; investors eye MariTide study  TradingView

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  • Nuvalent to Present Patient-Reported Outcomes Data from ARROS-1 Trial of ROS1-Selective Inhibitor, Zidesamtinib, at 2025 IASLC ASCO North America Conference on Lung Cancer

    Nuvalent to Present Patient-Reported Outcomes Data from ARROS-1 Trial of ROS1-Selective Inhibitor, Zidesamtinib, at 2025 IASLC ASCO North America Conference on Lung Cancer

    Encore pivotal efficacy and safety data from the ARROS-1 trial also to be presented during poster session

    CAMBRIDGE, Mass., Nov. 4, 2025 /PRNewswire/ — Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the first presentation of patient-reported outcomes data from the Phase 2 portion of the ARROS-1 Phase 1/2 clinical trial of zidesamtinib, an investigational ROS1 inhibitor, as well as encore pivotal efficacy and safety data from the ARROS-1 trial, during two poster presentations at the 2025 IASLC ASCO North America Conference on Lung Cancer being held December 5-7, 2025 in Chicago.

    Details of the poster presentations are as follows:

    Title: Patient-Reported Outcomes and Health-Related Quality of Life of TKI Pre-Treated and TKI-naïve Patients with Advanced ROS1-Positive NSCLC Treated with Zidesamtinib: Examination of ARROS-1 Phase 2 Trial Data
    Abstract Number: PP01.41
    Presenting Author: Melissa Laurie, Pharm.D., M.S., M.B.A.1
    Session Date and Time: Saturday, December 6, 2025, 4:00-5:30 p.m. ET

    Title: Zidesamtinib in Patients With Advanced Metastatic ROS1-Positive (ROS1+) Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Tyrosine Kinase Inhibitors (TKI): Pivotal Efficacy and Safety Data From the Phase 1/2 ARROS-1 Trial
    Abstract Number: PP01.32
    Presenting Author: Stephen V. Liu, M.D.2
    Session Date and Time: Saturday, December 6, 2025, 4:00-5:30 p.m. ET

    1 Nuvalent, Inc., Cambridge, MA, USA; 2Georgetown University, Washington, DC, USA

    About Zidesamtinib and the ARROS-1 Phase 1/2 Clinical Trial

    Zidesamtinib is an investigational, novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC.

    Zidesamtinib is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ROS1-positive NSCLC patients who previously received at least one ROS1 TKI, or patients with other ROS1-positive solid tumors who had been previously treated. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of zidesamtinib, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The ongoing global, single arm, open label Phase 2 portion is designed with registrational intent for TKI-naïve and TKI pre-treated patients with advanced ROS1-positive NSCLC. Nuvalent completed its rolling NDA submission for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC in the third quarter of 2025 and continues to engage with the U.S. Food and Drug Administration (FDA) on potential opportunities for line-agnostic expansion.

    About Nuvalent
    Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs.

    SOURCE Nuvalent, Inc.

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  • CNH Industrial to invest $5 billion in US manufacturing and research

    CNH Industrial to invest $5 billion in US manufacturing and research

    Nov 4 (Reuters) – Farm and construction equipment maker CNH Industrial (CNH.N), opens new tab said on Tuesday it will invest nearly $5 billion over five years into manufacturing and research and development facilities in the United States.

    CNH also said it will stop production at its Burlington, Iowa, assembly plant by the second quarter of 2026, citing declining demand and underutilization.

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    It said the plant closure would affect about 200 employees.

    The company will report its third-quarter earnings on November 7.

    Reporting by Anshuman Tripathy in Bengaluru; Editing by Alan Barona

    Our Standards: The Thomson Reuters Trust Principles., opens new tab

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  • Entergy, Energy Transfer sign long-term natural gas transportation deal

    Entergy, Energy Transfer sign long-term natural gas transportation deal

    Nov 4 (Reuters) – Utility Entergy’s (ETR.N), opens new tab unit and pipeline firm Energy Transfer (ET.N), opens new tab have signed a 20-year agreement to deliver natural gas to North Louisiana, the companies said on Tuesday.

    The U.S. is poised to see a record surge in power demand this year and in 2026, led by data centers’ outsized energy needs, the U.S. Energy Information Administration estimates.

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    The companies said the pipeline would supply gas to Entergy’s new plants and serve projects such as Meta’s (META.O), opens new tab data center in Richland Parish.

    Energy Transfer will initially provide 250,000 million British thermal units (MMBtu) per day of transportation service beginning in February 2028 and continuing through January 2048.

    The deal also provides an option to Entergy to expand delivery capacity in the region to meet future energy demand.

    Reporting by Tanay Dhumal in Bengaluru; Editing by Sriraj Kalluvila

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  • The Estée Lauder Companies Announces Secondary Offering of Class A Common Stock by Selling Stockholders – The Estée Lauder Companies Inc.

    The Estée Lauder Companies Announces Secondary Offering of Class A Common Stock by Selling Stockholders – The Estée Lauder Companies Inc.

    NEW YORK–(BUSINESS WIRE)–
    The Estée Lauder Companies Inc. (NYSE: EL) today announces that trusts affiliated with descendants of Leonard A. Lauder (the “Selling Stockholders”) propose to sell 11,301,323 shares of the Company’s Class A Common Stock, par value $.01 per share, through a proposed registered public offering (the “Offering”).

    The Selling Stockholders will receive all of the proceeds from the Offering. The Company is not selling any shares of Class A Common Stock in the Offering and will not receive any proceeds from the Offering. The Selling Stockholders intend to use the proceeds of the Offering to assist with the settlement of Leonard A. Lauder’s estate, including to satisfy certain estate obligations such as estate taxes, debts and administration expenses.

    Based on shares outstanding as of October 23, 2025, following completion of the offering, members of the Lauder family will beneficially own, directly or indirectly, 82% of the outstanding voting power of the Company’s Common Stock. The Selling Stockholders and LAL Family Partners, L.P., an entity beneficially owned by descendants of Leonard A. Lauder, will be subject to a 90-day lock-up agreement with the underwriter.

    J.P. Morgan Securities LLC is acting as the sole underwriter of the Offering.

    The Company has filed an automatically effective shelf registration statement on Form S-3 (including a prospectus) with the Securities and Exchange Commission (the “SEC”) for the Offering to which this communication relates. Before you invest, you should read the prospectus in that registration statement, the accompanying prospectus supplement and other documents the Company has filed with the SEC for more complete information about the Company and the Offering. Copies of the preliminary prospectus supplement and accompanying base prospectus relating to the Offering, as well as copies of the final prospectus supplement once available, may be obtained for free on the SEC’s website at www.sec.gov or by contacting J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email: [email protected] and [email protected].

    This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    The Estée Lauder Companies Inc. is one of the world’s leading manufacturers, marketers and sellers of quality skin care, makeup, fragrance and hair care products, and is a steward of luxury and prestige brands globally. The Company’s products are sold in approximately 150 countries and territories under brand names including: Estée Lauder, Aramis, Clinique, Lab Series, Origins, M·A·C, La Mer, Bobbi Brown Cosmetics, Aveda, Jo Malone London, Bumble and bumble, Darphin Paris, TOM FORD, Smashbox, AERIN Beauty, Le Labo, Editions de Parfums Frédéric Malle, GLAMGLOW, KILIAN PARIS, Too Faced, Dr.Jart+, the DECIEM family of brands, including The Ordinary and NIOD, and BALMAIN Beauty.

    ELC-F

    Investors: Rainey Mancini

    [email protected]

    Media: Brendan Riley

    [email protected]

    Source: The Estée Lauder Companies Inc.

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  • Johnson & Johnson reinforces its leadership in hematology at ASH 2025 unveiling new paradigm-shifting research

    RARITAN, NJ, November 4, 2025 – Johnson & Johnson (NYSE: JNJ), a worldwide leader in hematology, today announced more than 46 poster presentations and 10 oral presentations on hematologic malignancies and other blood disorders will be presented at the 67th American Society of Hematology (ASH) Annual Meeting from December 6–9, 2025, in Orlando, Florida. Results will showcase practice-influencing evidence from across the Company’s diverse hematology portfolio and progress towards advancing next-generation therapies.

    “From first in-human molecules to early intervention and regimens with curative potential, our blood cancer portfolio is advancing new options and addressing unmet needs for patients around the globe,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. “This year’s data at ASH showcase the depth of our scientific expertise and bold approach to get in front of cancer.”

    “Johnson & Johnson is focused on improving outcomes and extending survival for patients,” said Imran Khan, M.D., Ph.D., Vice President, U.S. Hematology Medical Affairs, Johnson & Johnson Innovative Medicine. “We aim to deliver meaningful benefits for patients and their families—redefining standards of care across multiple myeloma, leukemia and lymphoma, and accelerating progress toward cures.”

    Multiple myeloma studies highlight the potential to improve survival outcomes and advance treatment options in earlier lines:

    CARVYKTI® (ciltacabtagene autoleucel)

    • Clinical benefit of CARVYKTI® in patients with standard-risk relapsed/refractory multiple myeloma from the CARTITUDE-1 and -4 studies (
      Oral #94)
    • Improvements in immune fitness and immune response associated with earlier line use of CARVYKTI® in CARTITUDE-4 (
      Oral #92)

    DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)

    • Minimal residual disease dynamics in post-transplant patients with newly diagnosed multiple myeloma who received maintenance therapy with DARZALEX FASPRO® plus lenalidomide versus lenalidomide alone in the AURIGA study (
      Oral #97)
    • Results from a study evaluating cardiac risk factors and adverse events in newly diagnosed amyloid light chain amyloidosis patients treated with DARZALEX FASPRO® plus bortezomib, cyclophosphamide, and dexamethasone from the Phase 2 AQUARIUS study (
      Oral #691)
    • Results from the AQUILA study evaluating DARZALEX FASPRO® monotherapy versus active monitoring in patients with high-risk smoldering multiple myeloma, with subgroup analyses based on Mayo 2018/IMWG 2020 risk criteria, cytogenetic features and patient age (
      Oral #372)

    TALVEY® (talquetamab-tgvs) and TECVAYLI® (teclistamab-cqyv)

    • Presentations from the RedirecTT-1 study, evaluating dual-antigen targeting combination of TALVEY® and TECVAYLI® in patients with relapsed/refractory multiple myeloma and extramedullary disease, highlighting new three-year follow-up Phase 1 results and updated Phase 2 extended follow-up data (
      Oral #698 and
      #701)
    • Updated safety and efficacy data from the Phase 1b MonumenTAL-2 study evaluating TALVEY® in combination with pomalidomide in patients with relapsed/refractory multiple myeloma (
      Poster #2282)
    • First data from the TALISMAN study reporting how in patients with relapsed/refractory multiple myeloma treated with TALVEY® taste changes present and change over time, along with the development and utility of the WETT-SA53 test in measuring taste changes (
      Poster #5821)

    Other Key Multiple Myeloma Studies

    • Updates from the ramantamig (JNJ-79635322) Phase 1 study, including MRD negativity rates, and data supporting how the recommended Phase 2 dose was identified in patients with relapsed/refractory multiple myeloma (
      Poster #4042 and
      #4054)
    • First presentation of preclinical data on JNJ-87562761, a next-generation GPRC5D monoclonal antibody with enhanced effector function, investigating the effectiveness of multiple mechanisms of action for the treatment of relapsed/refractory multiple myeloma (
      Poster #3934)
    • Real-world findings from REVEAL-MM, a U.S. claims-based case-control study evaluating early assessment variables and landmark trends in multiple myeloma (
      Poster #4569)

    Data highlight foundational treatments and next wave of therapies for leukemia and lymphoma:

    IMBRUVICA® (ibrutinib)

    • First presentation in the ASH Plenary Session will feature results from the Phase 3 CLL17 trial comparing fixed-duration IMBRUVICA® plus venetoclax and continuous targeted treatment with IMBRUVICA® for previously untreated chronic lymphocytic leukemia (CLL) (
      Plenary Scientific Session Abstract #1)
    • First results from the Phase 2 TAILOR study, reporting dose and BTK occupancy correlations from a pre-planned exploratory analysis of IMBRUVICA® monotherapy in patients with previously untreated CLL (
      Poster #3301)

    Bleximenib (JNJ-75276617)

    • Updated data from Phase 1b studies evaluating bleximenib (JNJ-75276617), an investigational oral menin inhibitor, as combination therapy for both newly diagnosed and relapsed/refractory patients with acute myeloid leukemia harboring KMT2A or NPM1 alterations (
      Poster #5199 and
      #5200)

    Prizlo-cel (JNJ-90014496)

    • Biomarker correlations with clinical outcomes from a global Phase 1b study of prizlo-cel (JNJ-90014496), an investigational dual-targeting anti-CD20/CD19 CAR T-cell therapy in patients with large B-cell lymphoma (LBCL) (
      Oral #568)

    Hematologic autoantibody disease research:

    An oral presentation and seven poster presentations on warm autoimmune hemolytic anemia (wAIHA) will spotlight the Company’s innovative research addressing the critical need for approved therapies for this rare, life-threatening disease in which autoantibodies cause the premature destruction of red blood cells, resulting in anemia. Observational and qualitative studies demonstrate the profound burden of both the disease and current standard of care treatment options for people living with wAIHA.

    Information on abstracts sponsored by Johnson & Johnson is available on JNJ.com.

    About Multiple Myeloma
    Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.1 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.2 Multiple myeloma is the third most common blood cancer worldwide and remains an incurable disease.3 In 2024, it was estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 people would die from the disease.4 People living with multiple myeloma have a 5-year survival rate of 59.8 percent.5 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.6,7

    About Smoldering Multiple Myeloma
    Smoldering multiple myeloma (SMM) is an asymptomatic intermediate disease state of multiple myeloma characterized by abnormal monoclonal bone marrow plasma cell (BMPC) proliferation and abnormally high levels of circulating M proteins with absence of myeloma-defining events. SMM is associated with a 10 percent annual risk of progressing to multiple myeloma (MM) or a related disorder, but half of patients with high-risk SMM progress to MM and are at risk of developing severe symptoms and organ damage within just two years of diagnosis.

    About Acute Myeloid Leukemia (AML)
    Acute myeloid leukemia is an aggressive, fast-growing blood cancer that originates in the bone marrow and is marked by the uncontrolled proliferation of immature white blood cells known as myeloblasts.8,9 These malignant cells crowd out healthy blood-forming cells, leading to complications such as anemia, infections and bleeding.10 Acute myeloid leukemia progresses rapidly, often requiring immediate treatment after diagnosis.8 It is the most common type of acute leukemia in adults, with a median age of diagnosis around 70 years.7

    Despite treatment advances, acute myeloid leukemia remains associated with poor patient outcomes, particularly in older adults or those with high-risk genetic profiles.11 The five-year survival rate remains the lowest among leukemias, with outcomes especially poor in patients with KMT2Ar or NPM1m where relapse/refractory disease survival can be as short as 2 to 3 months after a second relapse – highlighting a significant unmet medical need.10

    About large B-cell lymphoma
    Large B-cell lymphoma is a type of non-Hodgkin lymphoma (NHL), a blood cancer that originates in the lymphatic system, arising from abnormal B cells, a type of white blood cell responsible for producing antibodies to fight infections.12 The malignant cells grow rapidly in lymph nodes or other organs and can spread quickly throughout the body.11 These abnormal cells are larger than normal, healthy B-cells. Diffuse (D) LBCL is the most common and aggressive type where cells are spread out (diffuse) rather than grouped together when they are examined under a microscope.11 DLBCL accounts for approximately 40 percent of all NHL cases globally and is estimated to have 150,000 new cases diagnosed each year.13 While some patients respond to initial treatment, up to 40 percent can relapse or become refractory to therapy.14 LBCL and DLBCL patients often face limited treatment options and a poor prognosis, highlighting the urgent need for innovative therapies. Common symptoms include rapidly growing lymph nodes, fever, night sweats, weight loss, and fatigue.11

    About Warm Autoimmune Hemolytic Anemia
    Warm autoimmune hemolytic anemia (wAIHA) is a rare, life-threatening condition where autoantibodies lead to the premature destruction of red blood cells (RBCs), resulting in anemia.15 Approximately 1-3 new people per 100,000 are affected by wAIHA per year, and about 1 in 8,000 individuals are living with the condition.14,16 This condition affects both women and men and can affect people at any age with incidence increasing over the age of 50.15,17 Additionally, people with wAIHA are at increased risk of other serious complications such as venous thrombotic events, acute renal failure, and infection.18

    There are no Food and Drug Administration (FDA)-approved drugs indicated for wAIHA, and treatment typically consists of corticosteroids, broad immunosuppressants and B-cell directed therapies.14 With an unmet need for treatment in wAIHA, continued research for evidence-based potential therapies is critical.17

    About CARVYKTI®
    CARVYKTI® (cilta-cel) received U.S. Food and Drug Administration approval in February 2022 for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.19 In April 2024, CARVYKTI® was approved in the U.S. fortreatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and who are refractory to lenalidomide, following a unanimous (11 to 0) FDA Oncologic Drugs Advisory Committee (ODAC) recommendation in support of this new indication. In April 2024, the European Medicines Agency (EMA) approved a Type II variation for CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. In September 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma in patients that have no history of CAR-positive T cell infusion therapy targeting BCMA and who have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy.

    CARVYKTI® is a BCMA-directed, autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding chimeric antigen receptor (CAR) that directs the CAR-positive T cells to eliminate cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. The CARVYKTI® CAR protein features two BCMA-targeting single domains designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.

    In December 2017, Janssen Biotech, Inc., a Johnson & Johnson company, entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize CARVYKTI®.

    For more information, visit www.CARVYKTI.com.

    About DARZALEX FASPRO® and DARZALEX®
    DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for ten indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.1,4 It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology.

    DARZALEX® (daratumumab) received U.S. FDA approval in November 2015 and is approved in ten indications, four of which are in the frontline setting, including newly diagnosed patients who are transplant eligible and ineligible.

    DARZALEX® is the first CD38-directed antibody approved to treat multiple myeloma. DARZALEX®-based regimens have been used in the treatment of more than 618,000 patients worldwide.

    In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen Biotech, Inc. an exclusive license to develop, manufacture and commercialize daratumumab.

    Since 2020, the National Comprehensive Cancer Network® (NCCN®) has recommended daratumumab-based combination regimens for the treatment of newly diagnosed multiple myeloma and relapsed and refractory multiple myeloma. For newly diagnosed multiple myeloma in non-transplant candidates, the NCCN® guidelines recommend daratumumab in combination with lenalidomide and dexamethasone as a Category 1 preferred regimen; daratumumab in combination with bortezomib, melphalan, and prednisone as another recommended Category 1 regimen; and daratumumab in combination with bortezomib, cyclophosphamide, and prednisone as another recommended Category 2A regimen. For newly diagnosed multiple myeloma in transplant candidates, the NCCN® guidelines recommend daratumumab in combination with bortezomib, lenalidomide and dexamethasone as another recommended Category 2A regimen; daratumumab in combination with bortezomib, thalidomide and dexamethasone as a Category 2A regimen useful in certain circumstances; daratumumab in combination with carfilzomib, lenalidomide and dexamethasone as a Category 2A regimen useful in certain circumstances; and daratumumab in combination with cyclophosphamide, bortezomib and dexamethasone as a Category 2A regimen useful in certain circumstances. For maintenance in transplant candidates, the NCCN guidelines recommend daratumumab in combination with lenalidomide as useful in certain circumstances. In relapsed/refractory myeloma, four daratumumab regimens are listed as Category 1 preferred regimens for early relapses (1-3 prior therapies): daratumumab in combination with lenalidomide and dexamethasone; daratumumab in combination with bortezomib and dexamethasone; daratumumab in combination with carfilzomib and dexamethasone; and daratumumab in combination with pomalidomide and dexamethasone [after one prior therapy including lenalidomide and a proteasome inhibitor (PI)]. The NCCN® also recommends daratumumab in combination with cyclophosphamide, bortezomib and dexamethasone as another Category 2A regimen for early relapses (1-3 prior therapies) and as monotherapy as a Category 2A regimen useful in certain circumstances for early relapse patients after at least three prior therapies, including a PI and an immunomodulatory agent, or for patients who are double refractory to a PI and an immunomodulatory agent.

    For more information, visit www.DARZALEX.com.

    About IMBRUVICA®
    IMBRUVICA® (ibrutinib) is a once-daily oral medication that is jointly developed and commercialized by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company. IMBRUVICA® blocks the BTK protein, which is needed by normal and abnormal B cells, including specific cancer cells, to multiply and spread. By blocking BTK, IMBRUVICA® may help move abnormal B cells out of their nourishing environments and inhibit their proliferation.20,21,22

    IMBRUVICA® is approved in more than 100 countries and has been used to treat more than 325,000 patients worldwide over the last decade. There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, spanning more than 11 years, evaluating the efficacy and safety of IMBRUVICA®.

    IMBRUVICA® was first approved by the U.S. FDA in November 2013, and today is indicated for adult patients in four disease areas. These include indications to treat adults with chronic lymphocytic leukemia/small lymphocytic lymphoma with or without 17p deletion; adults with Waldenström’s macroglobulinemia; and adult and pediatric patients aged one year and older with previously treated chronic graft versus host disease after failure of one or more lines of systemic therapy.23

    About TALVEY®
    TALVEY® (talquetamab-tgvs) received approval from the U.S. FDA in August 2023 as a first-in-class GPRC5D-targeting bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.24 Since FDA approval, 7,700 patients were treated with TALVEY®. The European Commission (EC) granted conditional marketing authorization (CMA) of TALVEY® (talquetamab-tgvs) in August 2023 as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (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.25

    TALVEY® is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and G protein-coupled receptor class C group 5 member D (GPRC5D), a novel multiple myeloma target which is highly expressed on the surface of multiple myeloma cells and non-malignant plasma cells, as well as some healthy tissues such as epithelial cells of the skin and tongue.  

    About TECVAYLI®
    TECVAYLI® (teclistamab-cqyv) received approval from the U.S. FDA in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.26 Since FDA approval, more than 20,800 patients have been treated worldwide with TECVAYLI®. The European Commission (EC) granted TECVAYLI® conditional marketing authorization (CMA) in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy. In August 2023, the EC granted the approval of a Type II variation application for TECVAYLI®, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients who have achieved a complete response (CR) or better for a minimum of six months. TECVAYLI® is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In February 2024, the U.S. FDA approved the supplemental Biologics License Application (sBLA) for TECVAYLI® for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients with relapsed or refractory multiple myeloma who have achieved and maintained a CR or better for a minimum of six months.

    For more information, visit www.TECVAYLI.com.

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

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

    Footnotes
    1 Rajkumar SV. Multiple Myeloma: 2020 update on diagnosis, risk-stratification and management. American Journal of Hematology, 95(5), 548–567. https://doi.org/10.1002/ajh.25791

    2 National Cancer Institute. (2025, October). Plasma cell neoplasms. National Institutes of Health. Retrieved October 2025, from https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq

    3 City of Hope. (2022). Multiple myeloma: Causes, symptoms & treatments. Retrieved October 2025, from https://www.cancercenter.com/cancer-types/multiple-myeloma

    4 American Cancer Society. (2025, October). Myeloma cancer statistics. Retrieved from https://cancerstatisticscenter.cancer.org/types/myeloma

    5 Surveillance Research Program, National Cancer Institute. (2025, May). SEER Explorer: An interactive website for SEER cancer statistics [Internet]. National Institutes of Health. Retrieved from https://seer.cancer.gov/explorer/

    6 American Cancer Society. (2025, October). What is multiple myeloma? Retrieved from https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html

    7 American Cancer Society. (2025, October). Multiple myeloma early detection, diagnosis, and staging. Retrieved from https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html

    8 The Leukemia & Lymphoma Society. (2023). Facts 2022–2023: Updated data on blood cancers. Retrieved October 2025, from https://www.lls.org/sites/default/files/2023-08/PS80_Facts_2022_2023.pdf

    9 MD Anderson Cancer Center. (2025, October). Acute myeloid leukemia. Retrieved from https://www.mdanderson.org/cancer-types/acute-myeloid-leukemia.html

    10 American Cancer Society. (2025, October). Signs and symptoms of acute myeloid leukemia (AML). Retrieved from https://www.cancer.org/cancer/types/acute-myeloid-leukemia/detection-diagnosis-staging/signs-symptoms.html

    11 Shimony, S., Stahl, M., & Stone, R. M. (2023). Acute myeloid leukemia: 2023 update on diagnosis, risk-stratification, and management. American Journal of Hematology, 98(3), 502–526. https://doi.org/10.1002/ajh.26822

    12 Lymphoma Action. (2025, October). Diffuse large B-cell lymphoma. Retrieved from https://lymphoma-action.org.uk/types-lymphoma-non-hodgkin-lymphoma/diffuse-large-b-cell-lymphoma

    13 Berhan, A., et al. (2025, February 15). Diffuse large B cell lymphoma (DLBCL): Epidemiology, pathophysiology, risk stratification, advancement in diagnostic approaches and prospects: Narrative review. Discover Oncology, 16, 184. https://link.springer.com/content/pdf/10.1007/s12672-025-01958-w.pdf

    14 García-Sancho, A. M., et al. (2023, December 22). Treatment of relapsed or refractory diffuse large B-cell lymphoma: New approved options. Journal of Clinical Medicine, 13(1), 70. https://www.mdpi.com/2077-0383/13/1/70.

    14 National Organization for Rare Disorders. (2025, October). Warm autoimmune hemolytic anemia. Retrieved from https://rarediseases.org/rare-diseases/warm-autoimmune-hemolytic-anemia/

    16 Tranekær, S., Hansen, D. L., & Frederiksen, H. (2021, March 17). Epidemiology of secondary warm autoimmune haemolytic anaemia: A systematic review and meta-analysis. Journal of Clinical Medicine, 10(6), 1244. https://doi.org/10.3390/jcm10061244

    17 Cherif, H., Cai, Q., Crivera, C., Leon, A., Rahman, I., Leval, A., Noel, W., & Kjellander, C. (2024). Overall survival and treatment patterns among patients with warm autoimmune hemolytic anemia in Sweden: A nationwide population-based study. European Journal of Haematology. https://doi.org/10.1111/ejh.14311

    18 Fattizzo, B., & Barcellini, W. (2022, October). New therapies for the treatment of warm autoimmune hemolytic anemia. Transfusion Medicine Reviews, 36(4). https://doi.org/10.1016/j.tmrv.2022.08.001

    19 CARVYKTI® U.S. Prescribing Information.

    20 National Library of Medicine. (2025, October). Isolated growth hormone deficiency. Retrieved from http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency

    21 Turetsky, A., et al. (2014). Single cell imaging of Bruton’s tyrosine kinase using an irreversible inhibitor. Scientific Reports, 6, 4782.

    22 de Rooij, M. F., Kuil, A., Geest, C. R., et al. (2012). The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. Blood, 119(11), 2590–2594.

    23 IMBRUVICA® U.S. Prescribing Information, August 2022.

    24 TALVEY® U.S. Prescribing Information, August 2023.

    25 European Medicines Agency. TALVEY Summary of Product Characteristics. August 2023.

    26 Johnson & Johnson. (2025, October). U.S. FDA approves TECVAYLI® (teclistamab-cqyv), the first bispecific T-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma. Retrieved from https://www.jnj.com/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma


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