Category: 3. Business

  • DARZALEX FASPRO® is the first and only treatment approved by the U.S. FDA for patients with high-risk smoldering multiple myeloma

    Horsham, PA., November 6, 2025 – Johnson & Johnson (NYSE:JNJ) today announced the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM).1 DARZALEX FASPRO® is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma.

    FDA approval is based on findings from the AQUILA study (
    NCT03301220), which evaluated the efficacy and safety of DARZALEX FASPRO® compared to active monitoring (or “Watch and Wait”) in the largest Phase 3 trial in patients with HR-SMM. The AQUILA study demonstrated a significant improvement in the primary endpoint of progression-free survival (PFS), with DARZALEX FASPRO® reducing the risk of disease progression to active multiple myeloma or death by 51 percent compared to active monitoring, according to the International Myeloma Working Group (IMWG) diagnostic criteria for multiple myeloma. Today’s milestone follows the
    May 2025 vote by the U.S. FDA Oncologic Drugs Advisory Committee (ODAC) in favor of the benefit-risk profile of DARZALEX FASPRO® as a single agent treatment for patients with HR-SMM.

    Smoldering multiple myeloma (SMM) is an asymptomatic malignancy that is genomically the same as active multiple myeloma and where these abnormal cells can be detected in the bone marrow.2,3,4 In 2025, it is estimated that more than 36,000 people will be diagnosed with multiple myeloma in the U.S., and approximately 15 percent of those are classified as smoldering.5,6 An estimated 50 percent of patients diagnosed with HR-SMM are likely to progress to active disease within two years of diagnosis.6 Currently, the standard of care for HR-SMM is active monitoring to track signs of biochemical progression and/or end-organ damage. Recent evidence suggests that people at high-risk of progressing to active multiple myeloma could benefit from earlier therapeutic intervention.6

    “Until now, patients diagnosed with smoldering multiple myeloma only have the option to watch and wait for any active signs of progression to active disease,” said Peter Voorhees, M.D., Atrium Health/Levine Cancer Institute, Charlotte, N.C.* “Results from AQUILA demonstrated DARZALEX FASPRO significantly delayed disease progression, underscoring the role of early disease intervention for patients with high-risk smoldering multiple myeloma.”

    The Phase 3 AQUILA study showed after a median follow-up of 65.2 months, 63.1 percent of patients who received DARZALEX FASPRO® had not progressed to active myeloma at 5 years (60 months) versus 40.7 percent in the active monitoring group (hazard ratio [HR], 0.49; 95 percent confidence interval [CI], 0.36-0.67; P<0.001). Today, most physicians use the Mayo 2018 criteria (20/2/20) to assess risk status in patients with smoldering myeloma. In a post hoc analysis of AQUILA, 41 percent of patients met the Mayo 2018 HR-SMM classification. Among these patients, median PFS was not reached in the DARZALEX FASPRO® arm and was 22.1 months in the active monitoring arm (HR, 0.36; 95 percent CI, 0.23-0.58).1

    Beyond the primary endpoint of PFS, patients in AQUILA who received DARZALEX FASPRO® saw a higher response rate of 63.4 percent compared to 2.0 percent with active monitoring (P<0.001). The median time to patients receiving first-line multiple myeloma treatment was delayed for patients receiving DARZALEX FASPRO® compared to active monitoring, with median time to first treatment NR vs 50.2 months for the active monitoring group (HR, 0.46; 95 percent CI, 0.33-0.62).1

    “DARZALEX FASPRO is a foundational therapy in multiple myeloma and illustrates our commitment to improve outcomes for patients at every stage of their disease,” said Jordan Schecter, M.D., Vice President, Research & Development, Multiple Myeloma, Oncology, Johnson & Johnson Innovative Medicine. “Data from the AQUILA study reinforce the significant impact DARZALEX FASPRO continues to have for patients. With today’s approval, patients with HR-SMM will now be able to receive this treatment before they progress to active multiple myeloma, giving us the opportunity to shift the treatment paradigm and bring hope to people who are impacted by this disease.”

    Adverse reactions observed in the pivotal AQUILA study were generally consistent with previous DARZALEX FASPRO® studies. The most common adverse reactions (≥20%) in patients with HR-SMM who received DARZALEX FASPRO® monotherapy are upper respiratory tract infection, musculoskeletal pain, fatigue, diarrhea, rash, sleep disorder, sensory neuropathy, and injection site reactions.1

    Results from AQUILA were first
    presented at the 2024 American Society of Hematology (ASH) Annual Meeting and simultaneously published in
    The New England Journal of Medicine. A subgroup analysis from the AQUILA study, evaluating the efficacy and safety of DARZALEX FASPRO® monotherapy in patients with HR-SMM using IMWG 2020 and IMWG 2020 plus cytogenetic risk models, will be
    presented at the 2025 ASH Annual Meeting in Orlando from December 6-9.

    About the AQUILA Study
    AQUILA (
    NCT03301220) is a randomized, multicenter Phase 3 study comparing treatment with DARZALEX FASPRO® to active monitoring in patients with SMM. Patients received single agent DARZALEX FASPRO® as a fixed-duration treatment for up to 36 months. The primary endpoint is progression-free survival (PFS), defined as progression to active multiple myeloma (MM) as assessed by an independent review committee, according to IMWG diagnostic criteria for MM (SLiM-CRAB), or death. Major secondary endpoints included overall response rate, PFS on first-line MM treatment (PFS2), and overall survival. Forty-one percent of patients had 2 or more of the following criteria for high-risk smoldering multiple myeloma: serum monoclonal protein level >2 g/dL, involved-to-uninvolved serum-free light chain ratio >20, and bone marrow plasma cells >20%. DARZALEX FASPRO® is only indicated for patients with high-risk smoldering multiple myeloma and is not indicated for other risk categories.

    About Multiple Myeloma
    Multiple myeloma is a blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.7 In multiple myeloma, these malignant plasma cells proliferate and replace normal cells in the bone marrow.8 Multiple myeloma is the second most common blood cancer worldwide and remains an incurable disease.9 In 2025, it is estimated that more than 36,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 will die from the disease.5 People with multiple myeloma have a 5-year survival rate of 59.8 percent.10 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, kidney problems or infections.2,10

    About Smoldering Multiple Myeloma
    Smoldering multiple myeloma (SMM) is an asymptomatic precursor disease state of multiple myeloma where abnormal cells can be detected in the bone marrow.11 People living with SMM do not show signs or symptoms typically associated with active myeloma, such as bone pain, bone fractures, kidney problems, or anemia. However, as abnormal plasma cells are present, organ damage may begin and progress asymptomatically.4,6 Approximately fifteen percent of all cases are classified as SMM, and half of those diagnosed with high-risk SMM are estimated to progress to active multiple myeloma within two years.6

    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 It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology.

    DARZALEX® (daratumumab) received
    U.S. FDA approval in November 2015 and is approved in eight indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant-eligible and ineligible.12

    DARZALEX® is the first CD38-directed antibody approved to treat multiple myeloma.12 DARZALEX®-based regimens have been used in the treatment of more than 618,000 patients worldwide and more than 68,000 patients in the U.S. alone.

    In
    August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab
    For more information, visit
    www.DARZALEX.com.

    DARZALEX FASPRO® INDICATIONS AND IMPORTANT SAFETY INFORMATION

    INDICATIONS
    DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma:

    • In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant
    • In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
    • In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
    • In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
    • In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (PI)
    • In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
    • In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
    • As monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent

    DARZALEX FASPRO® as monotherapy is indicated for the treatment of adult patients with high-risk smoldering multiple myeloma.

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS
    DARZALEX FASPRO® is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation.

    WARNINGS AND PRECAUTIONS

    Hypersensitivity and Other Administration Reactions
    Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO®. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO®.

    Systemic Reactions
    In a pooled safety population of 1446 patients with multiple myeloma (N=1235) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO® as monotherapy or in combination, 7% of patients experienced a systemic administration-related reaction (Grade 2: 3%, Grade 3: 0.8%, Grade 4: 0.1%).In patients with high-risk smoldering multiple myeloma (N=193), systemic administration-related reactions occurred in 17% of patients in AQUILA (Grade 2: 7%, Grade 3: 1%).

    In all patients (N=1639), systemic administration-related reactions occurred in 7% of patients with the first injection, 0.5% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 3.2 hours (range: 4 minutes to 3.5 days). Of the 283 systemic administration-related reactions that occurred in 135 patients, 240 (85%) occurred on the day of DARZALEX FASPRO® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients.

    Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision.

    Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO®. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions.

    Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO®.

    Local Reactions
    In this pooled safety population of 1446 patients with multiple myeloma (N=1253) or light chain amyloidosis (N=193), injection-site reactions occurred in 8% of patients, including Grade 2 reactions in 1.1%. The most frequent (>1%) injection-site reaction were injection site erythema and injection site rash. In patients with high-risk smoldering multiple myeloma (N=193), injection-site reactions occurred in 28% of patients, including Grade 2 reactions in 3%. These local reactions occurred a median of 6 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO®. Monitor for local reactions and consider symptomatic management.

    Infections
    DARZALEX FASPRO® can cause serious, life-threatening, or fatal infections. In patients who received DARZALEX FASPRO® in a pooled safety population including patients with smoldering multiple myeloma and light chain (AL) amyloidosis (N=1639), serious infections, including opportunistic infections, occurred in 24% of patients, Grade 3 or 4 infections occurred in 22%, and fatal infections occurred in 2.5%. The most common type of serious infection reported was pneumonia (8.5%).

    Monitor patients for signs and symptoms of infection prior to and during treatment with DARZALEX FASPRO® and treat appropriately. Administer prophylactic antimicrobials according to guidelines.

    Neutropenia
    Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO® until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO®, higher rates of Grade 3-4 neutropenia were observed.

    Thrombocytopenia
    Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. Consider withholding DARZALEX FASPRO® until recovery of platelets.

    Embryo-Fetal Toxicity
    Based on the mechanism of action, DARZALEX FASPRO® can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO® and for 3 months after the last dose.

    The combination of DARZALEX FASPRO® with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy.

    Interference With Serological Testing
    Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient’s serum. The determination of a patient’s ABO and Rh blood type are not impacted.

    Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO®. Type and screen patients prior to starting DARZALEX FASPRO®.

    Interference With Determination of Complete Response
    Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO®-treated patients with IgG kappa myeloma protein.

    ADVERSE REACTIONS
    In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, rash, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, musculoskeletal pain, upper respiratory tract infection, peripheral neuropathy, peripheral sensory neuropathy, constipation, pneumonia, edema, peripheral edema, and anemia.

    The most common adverse reactions (≥20%) in patients with high-risk smoldering multiple myeloma who received DARZALEX FASPRO® monotherapy are upper respiratory tract infection, musculoskeletal pain, fatigue, diarrhea, rash, sleep disorder, sensory neuropathy, and injection site reactions.

    The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.

    Please
    click here to read the full Prescribing Information for DARZALEX FASPRO®.

    DARZALEX® INDICATIONS AND IMPORTANT SAFETY INFORMATION

    INDICATIONS
    DARZALEX® (daratumumab) is indicated for the treatment of adult patients with multiple myeloma:

    • In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
    • In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
    • In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
    • In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor
    • In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
    • In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
    • As monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent

    CONTRAINDICATIONS
    DARZALEX® is contraindicated in patients with a history of severe hypersensitivity (eg, anaphylactic reactions) to daratumumab or any of the components of the formulation.

    WARNINGS AND PRECAUTIONS

    Infusion-Related Reactions
    DARZALEX® can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life threatening, and fatal outcomes have been reported. In clinical trials (monotherapy and combination: N=2066), infusion-related reactions occurred in 37% of patients with the Week 1 (16 mg/kg) infusion, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions. Less than 1% of patients had a Grade 3/4 infusion-related reaction at Week 2 or subsequent infusions. The median time to onset was 1.5 hours (range: 0 to 73 hours). Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX®. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension and blurred vision.

    When DARZALEX® dosing was interrupted in the setting of ASCT (CASSIOPEIA) for a median of 3.75 months (range: 2.4 to 6.9 months), upon re-initiation of DARZALEX®, the incidence of infusion-related reactions was 11% for the first infusion following ASCT. Infusion-related reactions occurring at re-initiation of DARZALEX® following ASCT were consistent in terms of symptoms and severity (Grade 3 or 4: <1%) with those reported in previous studies at Week 2 or subsequent infusions. In EQUULEUS, patients receiving combination treatment (n=97) were administered the first 16 mg/kg dose at Week 1 split over two days, ie, 8 mg/kg on Day 1 and Day 2, respectively. The incidence of any grade infusion-related reactions was 42%, with 36% of patients experiencing infusion-related reactions on Day 1 of Week 1, 4% on Day 2 of Week 1, and 8% with subsequent infusions.

    Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. Frequently monitor patients during the entire infusion. Interrupt DARZALEX® infusion for reactions of any severity and institute medical management as needed. Permanently discontinue DARZALEX® therapy if an anaphylactic reaction or life-threatening (Grade 4) reaction occurs and institute appropriate emergency care. For patients with Grade 1, 2, or 3 reactions, reduce the infusion rate when re-starting the infusion.

    To reduce the risk of delayed infusion-related reactions, administer oral corticosteroids to all patients following DARZALEX® infusions. Patients with a history of chronic obstructive pulmonary disease may require additional post-infusion medications to manage respiratory complications. Consider prescribing short- and long-acting bronchodilators and inhaled corticosteroids for patients with chronic obstructive pulmonary disease.

    Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX® infusion. If ocular symptoms occur, interrupt DARZALEX® infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX®.

    Interference With Serological Testing
    Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient’s serum. The determination of a patient’s ABO and Rh blood type is not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX®. Type and screen patients prior to starting DARZALEX®.

    Neutropenia and Thrombocytopenia
    DARZALEX® may increase neutropenia and thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX® until recovery of neutrophils or for recovery of platelets.

    Interference With Determination of Complete Response
    Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.

    Embryo-Fetal Toxicity
    Based on the mechanism of action, DARZALEX® can cause fetal harm when administered to a pregnant woman. DARZALEX® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX® and for 3 months after the last dose.

    The combination of DARZALEX® with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, pomalidomide, or thalidomide prescribing information on use during pregnancy.

    ADVERSE REACTIONS
    The most frequently reported adverse reactions (incidence ≥20%) were: upper respiratory infection, neutropenia, infusion related reactions, thrombocytopenia, diarrhea, constipation, anemia, peripheral sensory neuropathy, fatigue, peripheral edema, nausea, cough, pyrexia, dyspnea, and asthenia. The most common hematologic laboratory abnormalities (≥40%) with DARZALEX® are: neutropenia, lymphopenia, thrombocytopenia, leukopenia, and anemia.

    Please
    click here to read the full Prescribing Information for DARZALEX®.

    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 and Janssen Biotech, Inc. are both 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 DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj). 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
    * Peter Voorhees, M.D., Atrium Health/Levine Cancer Institute, Charlotte, N.C., has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

    1 DARZALEX FASPRO® U.S. Prescribing Information

    2 American Cancer Society. What is Multiple Myeloma? Accessed November 2025. Available at: https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html

    3 Oben, B, Froyen, G, Maclachlan, K.H, et al. Whole-genome sequencing reveals progressive versus stable myeloma precursor conditions as two distinct entities. Nat Commun 2021;12(1861). doi:10.1038/s41467-021-22140-0

    4 Maura, F, Bergsagel PL. Targeting the Tumor and the Immune System in Smoldering Multiple Myeloma. N Engl J Med. 2025;392:1858-1860. doi: 10.1056/NEJMe2504273

    5 American Cancer Society. Myeloma Cancer Statistics. Accessed November 2025. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html

    6 M.A. Dimopoulos, et al. Phase 3 Randomized Study of Daratumumab Monotherapy Versus Active Monitoring in Patients With High-risk Smoldering Multiple Myeloma: Primary Results of the AQUILA Study. Presented at the December 2024 ASH Annual Meeting & Exposition. Abstract JJD-78127.

    7 Rajkumar SV. Multiple Myeloma: 2020 Update on Diagnosis, Risk-Stratification and Management. Am J Hematol. 2020;95(5):548-5672020;95(5):548-567. http://www.ncbi.nlm.nih.gov/pubmed/32212178

    8 National Cancer Institute. Plasma Cell Neoplasms. Accessed November 2025. Available at: https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq

    9 Multiple Myeloma. City of Hope, 2022. Multiple Myeloma: Causes, Symptoms & Treatments. Accessed November 2025. Available at: https://www.cancercenter.com/cancer-types/multiple-myeloma

    10 American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging. Accessed November 2025. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html

    11 WebMD. Smoldering Multiple Myeloma. Accessed November 2025. Available at: https://www.webmd.com/cancer/multiple-myeloma/smoldering-multiple-myeloma

    12 DARZALEX® U.S. Prescribing Information


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  • IBM Advances to Next Phase of DARPA Quantum Benchmarking Initiative

    IBM Advances to Next Phase of DARPA Quantum Benchmarking Initiative

    IBM moves to second stage of program that rigorously and objectively validates approaches to building a large-scale fault-tolerant quantum computer

    Nov 6, 2025

    November 6, 2025 — YORKTOWN HEIGHTS, New York – IBM (NYSE: IBM) today announced it has been selected for Stage B, the second of three stages of the Quantum Benchmarking Initiative led by DARPA, the United States Defense Advanced Research Projects Agency.

    As the independent research and development arm of the U.S. Department of Defense, DARPA’s work focuses on identifying, creating, and supporting transformational, high-reward technologies for national security. In 2024, DARPA launched the Quantum Benchmarking Initiative (QBI) to determine the feasibility of building an industrially fault-tolerant quantum computer whose computational value exceeds its cost.

    The program is designed to rigorously validate and verify multiple approaches towards delivering such a quantum computer by 2033.

    “IBM’s progression to Stage B of DARPA’s Quantum Benchmarking Initiative is a firm validation of IBM’s approach to delivering a large-scale, fault-tolerant quantum computer,” said Jay Gambetta, Director of IBM Research. “IBM has publicly laid out our comprehensive plan and roadmap to scale quantum computers towards fault-tolerance. As the industry advances, we look forward to working with DARPA as they continue an unbiased review of potential viable strategies across the field.” 

    QBI aims to support the Stage B “performers’” ongoing research and development efforts through third-party verification and validation of their strategy.

    As part of the initiative, IBM is also aiming to explore novel approaches to scaling control systems for quantum computers with SEEQC.

    Each successful QBI performer will progress through three stages of the program:

    • Stage A required an initial technical concept of a cost-effective, fault-tolerant quantum computer that has a plausible path to realization in the near term. Stage A performers were announced in April 2025.
    • Announced today, Stage B called for a comprehensive research and development plan capable of realizing such a quantum computer, as well as the risks associated with this plan and mitigation approaches.
    • Stage C, according to DARPA, will be when “the QBI independent verification and validation (IV&V) team will test the companies’ computer hardware.”

    Visit the DARPA website for more information about the Quantum Benchmarking Initiative.

    About IBM

    IBM is a leading global hybrid cloud and AI, and business services provider, helping clients in more than 175 countries capitalize on insights from their data, streamline business processes, reduce costs and gain the competitive edge in their industries. Thousands of governments and corporate entities in critical infrastructure areas such as financial services, telecommunications and healthcare rely on IBM’s hybrid cloud platform and Red Hat OpenShift to affect their digital transformations quickly, efficiently and securely. IBM’s breakthrough innovations in AI, quantum computing, industry-specific cloud solutions and business services deliver open and flexible options to our clients. All of this is backed by IBM’s legendary commitment to trust, transparency, responsibility, inclusivity and service.

    For more information, visit https://research.ibm.com.


    Media Contact:

    Chris Nay

    IBM Research Communications

    cnay@us.ibm.com

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  • Bombardier Joins the U.S. Army’s Partnership for Your Success (PaYS) Program, Empowering Soldiers and Veterans in Career Transition

    Bombardier Joins the U.S. Army’s Partnership for Your Success (PaYS) Program, Empowering Soldiers and Veterans in Career Transition

    • The Partnership for Your Success (PaYS) Program connects service members with civilian career opportunities, offering guaranteed job interviews for qualified candidates with participating employers after military service
    • This program can offer transitioning U.S. service members meaningful industry experience in business aviation and defense, reflecting Bombardier’s deep commitment to supporting veterans as they reintegrate into civilian life and strengthening the company’s talent pipeline
    • As the first aviation company in Kansas to join the PaYS network, Bombardier strengthens its position as an employer of choice — both within the state and across the U.S.

    Bombardier today announced an official partnership with the United States Army through the Partnership for Your Success (PaYS) Program, a nationwide initiative that helps soldiers and veterans secure meaningful employment following their military service. Bombardier is the first aerospace company in the state of Kansas to be part of PaYS.  

    By signing the PaYS agreement, Bombardier becomes part of a distinguished network of over 1,000 public and private sector organizations that have committed to supporting the career success of America’s Soldiers. Through PaYS, qualified service members are guaranteed up to five job interviews, aligning applicants’ military skills with civilian career opportunities. 

    “Bombardier has an enduring partnership with the U.S. Army, and we are honored to deepen that relationship through our participation in the PaYS program,” said Steve Patrick, Vice President, Bombardier Defense. “As the first aviation company in Kansas to join PaYS, this milestone reflects our unwavering commitment to supporting America’s service members as they transition back to civilian life. With the continued expansion of our U.S. operations, we look forward to welcoming highly skilled veterans into our workforce.”     

    Bombardier has a strong footprint in the U.S., anchored by five service centres in key locations across the country – with a new site set to open in Fort Wayne in the second half of 2026 – and manufacturing facilities in Red Oak and Los Angeles. Through PaYS, qualified soldiers can take advantage of opportunities across Bombardier’s robust network supporting both civilian and military aircraft.  

    Established over 25 years ago, the PaYS Program connects soldiers — whether they serve on active duty, in the Army Reserve, or in the Army National Guard — with employers who recognize the value of their discipline, training, and leadership experience. Soldiers are eligible to participate in the program at the time of their enlistment and are guaranteed interviews with their selected partners upon completion of their service, provided job vacancies exist, and qualifications are met. For more information about the U.S. Army PaYS Program, visit
    www.armypays.com. 

    About Bombardier 

    At Bombardier (BBD-B.TO), we design, build, modify and maintain the world’s best-performing aircraft for the world’s most discerning people and businesses, governments and militaries. That means not simply exceeding standards, but understanding customers well enough to anticipate their unspoken needs.  

    For them, we are committed to pioneering the future of aviation—innovating to make flying more reliable, efficient and sustainable. And we are passionate about delivering unrivaled craftsmanship and care, giving our customers greater confidence and the elevated experience they deserve and expect. Because people who shape the world will always need the most productive and responsible ways to move through it. 

    Bombardier customers operate a fleet of more than 5,100 aircraft, supported by a vast network of Bombardier team members worldwide and 10 service facilities across six countries. Bombardier’s performance-leading jets are proudly manufactured in aerostructure, assembly and completion facilities in Canada, the United States and Mexico. In 2024, Bombardier was honoured with the prestigious “Red Dot: Best of the Best” award for Brands and Communication Design.     

    For Information 

    For corporate news and information, including Bombardier’s Sustainability report, as well as the company’s initiative to cover all its flight operations with a Sustainable Aviation Fuel (SAF) blend utilizing the Book-and-Claim system visit
    bombardier.com. 

    Learn more about Bombardier’s industry-leading products and customer service network at bombardier.com. Follow us on X @Bombardier. 

    Media Contacts 

    General media contact webform 

    Stephanie Faraggi  
    +1-514-513-7830 

    stephanie.faraggi@aero.bombardier.com 

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  • Sky owner Comcast in talks to buy ITV’s broadcasting arm for £2bn | ITV

    Sky owner Comcast in talks to buy ITV’s broadcasting arm for £2bn | ITV

    The parent company of Sky is in talks to buy ITV’s broadcasting business for about £2bn, two decades after James Murdoch made an audacious move to become the biggest shareholder in the UK’s largest commercial free-to-air broadcaster.

    US media company Comcast, which owns assets including Universal Studios and bought Rupert Murdoch’s Sky for £30bn in 2018, is in talks to buy ITV’s broadcasting arm, which includes its TV channels and streaming service ITVX.

    The move, which would upend the UK broadcasting landscape, reignites the ambitions of Rupert’s youngest son, James, who acquired a 17.9% stake in ITV for £940m in 2006.

    A deal would not involve its production arm ITV Studios – the maker of shows including Love Island, I’m a Celebrity and hit drama Mr Bates vs The Post Office – which has been the subject of separate takeover talks.

    Sky, which took the stake to block a move by Richard Branson to buy ITV after cable companies NTL and Telewest merged to create Virgin Media, was ultimately forced by regulators to sell its holding.

    ITV’s largest single shareholder, Liberty Global, which jointly owns Virgin Media O2 with Spanish telecoms operator Telefónica, halved its 10% stake in ITV last month.

    The broadcaster’s share price has slumped to £2.5bn, about 75% below levels seen a decade ago, as the Netflix-led streaming revolution has hammered the stocks of traditional broadcasters.

    On Thursday, ITV reported that it would “temporarily” cut £35m from its budgets as it deals the poor macroeconomic environment and advertiser uncertainty ahead of the budget later this month.

    The company said it expected advertising revenues, which still account for most of its income, to fall by 9% in the key fourth-quarter advertising in the run-up to Christmas.

    ITV is being advised by banks Robey Warshaw and Morgan Stanley.

    The performance of ITV Studios has led analysts to argue that the production arm alone could be worth more than the broadcasting business, which includes some of the UK’s most popular channels in linear.

    Since buying Sky at a premium in a bidding war in 2018, Comcast has written down the value of the business by billions of dollars, mainly due to the poor performance of European operations in Italy and Germany.

    Sky UK, which controls rights to crown-jewel assets including most of the rights to the Premier League, remains highly profitable.

    In June, Comcast agreed to sell its German pay-TV business to RTL, the former owner of Channel 5 in the UK, for €150m.

    ITV, Sky and Comcast declined to comment.

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  • Elon Musk’s $1tn pay deal approved by Tesla shareholders

    Elon Musk’s $1tn pay deal approved by Tesla shareholders

    Lily JamaliNorth America Technology correspondent

    Watch: Tesla shareholders cheer Elon Musk’s $1tn pay deal

    Tesla boss Elon Musk has had a record-breaking pay package that could be worth nearly $1tn (£760bn) approved by shareholders.

    The unprecedented deal was approved by 75% of votes and drew huge applause from the audience at the firm’s annual general meeting on Thursday.

    Musk, who is already the world’s richest man, must drastically raise the electric car firm’s market value over 10 years. If he does this and meets various targets, he will be rewarded with hundreds of millions of new shares.

    The scale of the potential payout has drawn criticism, but the Tesla board argued that Musk might leave the company if it was not approved – and that it could not afford to lose him.

    Following the announcement, Musk took to the stage in Austin, Texas and danced to chants of his name.

    “What we’re about to embark upon is not merely a new chapter of the future of Tesla, but a whole new book,” he said.

    “Other shareholder meetings are snoozefests but ours are bangers. Look at this. This is sick,” he added.

    The milestones Musk must achieve over the next decade to maximise his payout include raising Tesla’s market value to $8.5tn from $1.4tn at time of writing.

    He would also need to get a million self-driving Robotaxi vehicles into commercial operation.

    But his early remarks on Thursday placed the spotlight on the Optimus robot, dashing the hopes of some long-time analysts and Tesla watchers who want Musk to focus on reviving the company’s electric vehicle business.

    Reuters Elon Musk wearing a blue suit and white shirt with his fingertips touching and resting on his lips against a black backgroundReuters

    Elon Musk will get hundreds of millions of new shares if he hits his targets

    “Let it sink in where Musk’s head is at,” wrote analyst Gene Munster, the managing partner at Deepwater Asset Management, on X.

    “His vision of the ‘new book’ starts with Optimus. No mention of cars, FDS and robotaxi yet.”

    Later, Musk did refer to FSD, shorthand for full-self driving, saying the company was “almost comfortable” allowing drivers to “text and drive essentially.”

    US regulators are investigating Tesla’s self-driving feature after multiple incidents, in which the cars drove through red lights or on the wrong side of the road, some resulting in crashes and injuries.

    Tesla shares were slightly higher in after hours trading but have risen more than 62% over the last six months.

    Sales have slid in the year since Musk aligned himself with US President Donald Trump – a relationship that disintegrated this past spring.

    Wedbush Securities’ Dan Ives, a tech analyst who has been a long-time advocate of Musk’s leadership of Tesla, called him “Tesla’s biggest asset” in a note published after the vote.

    “We continue to believe that the AI valuation is getting unlocked, and we believe the march to an AI driven valuation for TSLA over the next 6-9 months has now begun,” Mr Ives added.

    Reuters A Tesla Optimus robot next to a logo at the company’s booth at the 8th China International Import Expo in Shanghai, ChinaReuters

    Musk said everyone would want an Optimus robot

    Musk already held 13% of Tesla shares. Shareholders had twice ratified a pay package worth tens of billions of dollars if he achieved a tenfold increase in the company’s market value – which he did.

    But a Delaware judge rejected that pay deal on grounds that Tesla board members were too close to Musk.

    Tesla reincorporated from Delaware to Texas, and the Delaware Supreme Court is currently reviewing the lower court judge’s decision.

    The new pay package was rejected by several major insitutional investors including Norway’s sovereign wealth fund – the world’s largest national wealth fund – and the California Public Employees’ Retirement System (CalPERS) – the biggest public pension fund in the United States.

    That left Musk more reliant on Tesla’s unusually large volume of retail investors.

    Musk and his brother Kimbal, who also serves on the Tesla board, were both allowed to vote going into Thursdays meeting.

    In recent weeks, members of Tesla’s board of directors have helped lobby for Musk’s new pay package with a marketing blitz that riled some corporate governance experts.

    A video posted to votetesla.com showed board chair Robyn Denholm and director Kathleen Wilson-Thompson praising Musk.

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  • The Estée Lauder Companies 2025 Annual Meeting of Stockholders to Be Held on November 13, 2025 – The Estée Lauder Companies Inc.

    The Estée Lauder Companies 2025 Annual Meeting of Stockholders to Be Held on November 13, 2025 – The Estée Lauder Companies Inc.

    NEW YORK–(BUSINESS WIRE)–
    The Estée Lauder Companies Inc. (NYSE: EL) will hold its 2025 Annual Meeting of Stockholders virtually on Thursday, November 13, 2025 beginning at 9:00 a.m. (ET). Those wishing to access the webcast can visit: www.virtualshareholdermeeting.com/EL2025.

    For further information on the meeting, The Estée Lauder Companies’ proxy statement materials and other information are available at www.elcompanies.com/investors. Following the annual meeting, a webcast of the meeting will be available for replay on www.elcompanies.com/investors.

    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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  • Boeing and Somon Air Announce Commitment for Up to 14 Airplanes

    Boeing and Somon Air Announce Commitment for Up to 14 Airplanes

    • 787 Dreamliner purchase will open new intercontinental routes from Tajikistan
    • Airline looks to 737 MAX jets to grow, modernize all-737 fleet

    WASHINGTON, Nov. 6, 2025 /PRNewswire/ — Boeing (NYSE: BA) and Somon Air today announced Tajikistan’s national air carrier has committed to place its largest-ever order, selecting up to 14 fuel-efficient 787 Dreamliner and 737 MAX airplanes.

    Somon Air currently operates six Next-Generation 737 airplanes from Tajikistan to 25 destinations across Europe, Asia and the Middle East. With today’s agreement, the airline will place its first-ever widebody order for up to four 787-9 jets to enable international network expansion and up to 10 737-8 single-aisle jets, to modernize its all-737 fleet.

    “We are pleased to announce our commitment to expand our fleet with Boeing’s state-of-the-art 787 Dreamliner and 737 MAX airplanes,” said Abdulkosim Valiev, CEO of Somon Air. “This significant investment not only marks our first widebody order but also reinforces our dedication to providing exceptional service and comfort to our passengers. With flexibility built into this commitment, Somon Air can adjust its fleet further based on market demand.”

    Somon Air will launch new intercontinental routes from Dushanbe, Tajikistan with the 787-9, offering superior comfort to its passengers. The 737‑8 will form the foundation of the carrier’s short and medium‑haul network. Together, these airplanes deliver a 20–25 % fuel-use improvement compared to the airplanes they replace, enabling lower per-seat and maintenance costs.

    The agreement was signed during the C5+1 Summit as the U.S. marks the 10th anniversary of the diplomatic platform. When finalized and posted to Boeing’s Orders & Deliveries website, the order will support more than 11,000 jobs across the U.S.

    “Somon Air’s continued choice of Boeing as its strategic partner underscores their preference for Boeing jets to grow their route network,” said Paul Righi, Boeing vice president of Sales and Marketing for Eurasia and India. “The versatility of the 787-9 and 737-8, combined with their outstanding performance, range, and operating economics, provide Somon Air with the essential tools needed to scale its operations effectively.”

    The 787 Dreamliner family has opened more than 520 new nonstop routes never previously served and carried more than 1 billion passengers worldwide since its commercial introduction in 2011.

    Somon Air is the national airline of the Republic of Tajikistan, established in 2008. Based at Dushanbe International Airport, the airline operates regular passenger and charter flights to destinations across Europe, Asia, and the Middle East. Its fleet consists entirely of modern Boeing 737 aircraft. Somon Air is committed to maintaining the highest standards of flight safety, service quality, and innovations.

    A leading global aerospace company and top U.S. exporter, Boeing develops, manufactures and services commercial airplanes, defense products and space systems for customers in more than 150 countries. Our U.S. and global workforce and supplier base drive innovation, economic opportunity, sustainability and community impact. Boeing is committed to fostering a culture based on our core values of safety, quality and integrity.

    Contact
    Boeing Media Relations
    media@boeing.com

    SOURCE Boeing

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  • Biofuels in Brazil: From the Soil to the Sky – BloombergNEF

    Biofuels in Brazil: From the Soil to the Sky – BloombergNEF

    1. Biofuels in Brazil: From the Soil to the Sky  BloombergNEF
    2. The market tools and financial mechanisms scaling sustainable aviation fuel  ICC | International Chamber of Commerce
    3. Why Zero-emission Aircraft Deserve More Attention  Aviation Business Middle East
    4. Rewriting the Rules on Sustainability  Air Cargo Week
    5. Can SAF Make Progress in Mandates Without Incentives?  ResourceWise

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  • Huntsman Announces Third Quarter 2025 Earnings :: Huntsman Corporation (HUN)

    Huntsman Announces Third Quarter 2025 Earnings :: Huntsman Corporation (HUN)

    Third Quarter Highlights

    • Third quarter 2025 net loss attributable to Huntsman of $25 million compared to a net loss of $33 million in the prior year period; third quarter 2025 diluted loss per share of $0.14 compared to diluted loss per share $0.19 in the prior year period.
    • Third quarter 2025 adjusted net loss attributable to Huntsman of $5 million compared to adjusted net income of $17 million in the prior year period; third quarter 2025 adjusted diluted loss per share of $0.03 compared to adjusted diluted income per share of $0.10 in the prior year period.
    • Third quarter 2025 adjusted EBITDA of $94 million compared to $131 million in the prior year period.
    • Third quarter 2025 net cash provided by operating activities from continuing operations was $200 million. Free cash flow from continuing operations was $157 million for the third quarter 2025 compared to free cash flow of $93 million in the prior year period.
    • Regular quarterly dividend reset to $0.0875 per share, a decrease of 65% versus the prior dividend. This represents an annual dividend payout of $0.35 per share.














    Three months ended

    Nine months ended

    September 30, 

    September 30, 

    In millions, except per share amounts

    2025

    2024

    2025

    2024


    Revenues

    $     1,460

    $     1,540

    $     4,328

    $     4,584


    Net loss attributable to Huntsman Corporation

    $        (25)

    $        (33)

    $       (188)

    $        (48)

    Adjusted net (loss) income(1)

    $          (5)

    $          17

    $        (58)

    $          30


    Diluted loss per share

    $      (0.14)

    $      (0.19)

    $      (1.09)

    $      (0.28)

    Adjusted diluted (loss) income per share(1)

    $      (0.03)

    $       0.10

    $      (0.34)

    $       0.17


    Adjusted EBITDA(1)

    $          94

    $        131

    $        240

    $        343


    Net cash provided by operating activities from continuing operations

    $        200

    $        134

    $        221

    $        126

    Free cash flow from continuing operations(2)

    $        157

    $          93

    $        105

    $          (7)


    See end of press release for footnote explanations and reconciliations of non-GAAP measures.


     

    THE WOODLANDS, Texas, Nov. 6, 2025 /PRNewswire/ — Huntsman Corporation (NYSE: HUN) today reported third quarter 2025 results with revenues of $1,460 million, net loss attributable to Huntsman of $25 million, adjusted net loss attributable to Huntsman of $5 million and adjusted EBITDA of $94 million. 

    Peter R. Huntsman, Chairman, President, and CEO, commented:

    “As we expected, third quarter fundamentals remained consistent with the first half of the year. Volumes improved compared to the prior year while pricing in some parts of the portfolio remained under pressure. Cash generation and cost control remain top priorities for our Company. Our current restructuring programs, that will likely exceed $100 million in savings, remain on track and are expected to be completed in 2026. Additionally, our cash generation over the past year has been strong despite lower levels of profitability, reflecting quick actions taken on working capital and capital expenditure control in an ever-challenging environment. After thorough deliberation, and reflecting the global economic conditions of our industry, our Board decided to reset the regular dividend to 35 cents a share annually, a reduction of 65%. The adjusted dividend payout will allow us to preserve our financial flexibility as we continue to navigate this extended cyclical trough, while also allowing the Company to keep a balanced capital allocation program including a competitive regular dividend. We would anticipate returning to a higher dividend payout as soon as conditions warrant.”

    Segment Analysis for 3Q25 Compared to 3Q24

    Polyurethanes

    The decrease in revenues in our Polyurethanes segment for the three months ended September 30, 2025 compared to the same period of 2024 was primarily due to lower average selling prices, partially offset by higher sales volumes. MDI average selling prices decreased primarily due to less favorable supply and demand dynamics. Sales volumes increased primarily in the Americas and Asia regions. The decrease in segment adjusted EBITDA was primarily due to the impacts of lower average selling prices, inventory reductions and lower equity earnings from our minority-owned joint venture in China, partially offset by higher sales volumes, lower raw material costs and cost savings achieved from our cost optimization program.

    Performance Products

    The decrease in revenues in our Performance Products segment for the three months ended September 30, 2025 compared to the same period of 2024 was primarily due to lower sales volumes and lower average selling prices. Sales volumes decreased primarily due to the closure of our Moers, Germany maleic anhydride facility and overall softening market conditions. Average selling prices decreased primarily due to competitive pressures. The decrease in segment adjusted EBITDA was primarily due to lower sales volumes and margins.

    Advanced Materials

    The increase in revenues in our Advanced Materials segment for the three months ended September 30, 2025 compared to the same period of 2024 was primarily due to higher average selling prices. Average selling prices increased primarily due to the positive impact of major foreign currency exchange rate movements against the U.S. dollar. Sales volumes were essentially unchanged from the same period in 2024. Segment adjusted EBITDA was slightly lower primarily due to an unfavorable impact from inventory reductions.

    Liquidity and Capital Resources

    During the three months ended September 30, 2025, our free cash flow from continuing operations was $157 million as compared to $93 million in the same period of 2024. As of September 30, 2025, we had approximately $1.4 billion of combined cash and unused borrowing capacity.

    During the three months ended September 30, 2025, we spent $43 million on capital expenditures from continuing operations as compared to $41 million in the same period of 2024. During 2025, we expect to spend between approximately $170 million to $180 million on capital expenditures.

    Income Taxes

    In the third quarter of 2025, our effective tax rate was -43% and our adjusted effective tax rate was 40%.

    Earnings Conference Call Information

    We will hold a conference call to discuss our third quarter 2025 financial results on Friday, November 7, 2025, at 10:00 a.m. ET.

    Webcast link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=FbX1HK73

    Participant dial-in numbers:
    Domestic callers:                    (877) 402-8037
    International callers:               (201) 378-4913

    The conference call will be accompanied by presentation slides that will be accessible via the webcast link and Huntsman’s investor relations website, www.huntsman.com/investors. Upon conclusion of the call, the webcast replay will be accessible via Huntsman’s website.

    Upcoming Conferences
    During the fourth quarter 2025, a member of management is expected to present at:
    Seaport’s Chemical Cornucopia Conference, November 19, 2025
    Citi’s 2025 Basic Materials Conference, December 2, 2025
    Bank of America High Yield Conference, December 3, 2025

    A webcast of the presentation, if applicable, along with accompanying materials will be available at www.huntsman.com/investors.

     





































    Table 1 – Results of Operations


    Three months ended

    Nine months ended

    September 30, 

    September 30, 

    In millions, except per share amounts

    2025

    2024

    2025

    2024


    Revenues

    $     1,460

    $     1,540

    $     4,328

    $     4,584

    Cost of goods sold

    1,256

    1,306

    3,741

    3,906

    Gross profit

    204

    234

    587

    678

    Operating expenses:


    Selling, general and administrative

    163

    153

    489

    505

    Research and development

    29

    27

    94

    91

    Restructuring, impairment and plant closing costs

    12

    5

    137

    20

    Gain on acquisition of assets, net

    (5)

    (51)

    Prepaid asset write-off

    71

    Income associated with litigation matter, net

    (33)

    Other operating (income) expense, net

    (6)

    7

    (23)

    4

    Total operating expenses

    198

    192

    659

    640

    Operating income (loss)

    6

    42

    (72)

    38

    Interest expense, net

    (20)

    (21)

    (60)

    (60)

    Equity in income of investment in unconsolidated affiliates

    1

    5

    42

    Other income, net

    6

    8

    13

    22

    (Loss) income from continuing operations before income taxes

    (7)

    34

    (119)

    42

    Income tax expense

    (3)

    (39)

    (25)

    (32)

    (Loss) income from continuing operations

    (10)

    (5)

    (144)

    10

    Income from discontinued operations, net of tax

    (1)

    (12)

    (1)

    (12)

    Net loss

    (11)

    (17)

    (145)

    (2)

    Net income attributable to noncontrolling interests

    (14)

    (16)

    (43)

    (46)

    Net loss attributable to Huntsman Corporation

    $        (25)

    $        (33)

    $       (188)

    $        (48)


    Adjusted EBITDA (1)

    $          94

    $        131

    $        240

    $        343

    Adjusted net (loss) income (1)

    $          (5)

    $          17

    $        (58)

    $          30


    Basic loss per share

    $      (0.14)

    $      (0.19)

    $      (1.09)

    $      (0.28)

    Diluted loss per share

    $      (0.14)

    $      (0.19)

    $      (1.09)

    $      (0.28)

    Adjusted diluted (loss) income per share (1)

    $      (0.03)

    $       0.10

    $      (0.34)

    $       0.17


    Common share information:


    Basic weighted average shares

    173

    172

    173

    172

    Diluted weighted average shares

    173

    172

    173

    172

    Diluted shares for adjusted diluted (loss) income per share

    173

    173

    173

    173


    See end of press release for footnote explanations.


     















    Table 2 – Results of Operations by Segment


    Three months ended

    Nine months ended


    September 30, 

    (Worse) /

    September 30, 

    (Worse) /

    In millions

    2025

    2024

    better

    2025

    2024

    better


    Segment revenues:


    Polyurethanes

    $        956

    $     1,003

    (5 %)

    $     2,800

    $     2,930

    (4 %)

    Performance Products

    246

    280

    (12 %)

    773

    870

    (11 %)

    Advanced Materials

    265

    261

    2 %

    778

    801

    (3 %)

    Total reportable segments’ revenues

    1,467

    1,544

    (5 %)

    4,351

    4,601

    (5 %)


    Intersegment eliminations

    (7)

    (4)

    n/m

    (23)

    (17)

    n/m


    Total revenues

    $     1,460

    $     1,540

    (5 %)

    $     4,328

    $     4,584

    (6 %)


    Segment adjusted EBITDA (1) :


    Polyurethanes

    $          48

    $          76

    (37 %)

    $        121

    $        195

    (38 %)

    Performance Products

    29

    42

    (31 %)

    91

    130

    (30 %)

    Advanced Materials

    44

    47

    (6 %)

    125

    142

    (12 %)

    n/m = not meaningful


    See end of press release for footnote explanations.


     







    Table 3 – Factors Impacting Sales Revenue



    Three months ended

    September 30, 2025 vs. 2024

    Average selling price (a)


    Local

    Exchange

    Sales


    currency & mix

    rate

    volume (b)

    Total



    Polyurethanes

    (10 %)

    1 %

    4 %

    (5 %)



    Performance Products

    (2 %)

    0 %

    (10 %)

    (12 %)



    Advanced Materials

    (1 %)

    2 %

    1 %

    2 %



    Combined segments

    (7 %)

    1 %

    1 %

    (5 %)



    Nine months ended

    September 30, 2025 vs. 2024

    Average selling price (a)


    Local

    Exchange

    Sales


    currency & mix

    rate

    volume (b)

    Total



    Polyurethanes

    (5 %)

    0 %

    1 %

    (4 %)



    Performance Products

    1 %

    0 %

    (12 %)

    (11 %)



    Advanced Materials

    (3 %)

    0 %

    0 %

    (3 %)



    Combined segments

    (4 %)

    0 %

    (2 %)

    (6 %)



    (a) Excludes sales from tolling arrangements, by-products and raw materials.


    (b) Excludes sales from by-products and raw materials.


     







































    Table 4 – Reconciliation of U.S. GAAP to Non-GAAP Measures


     Income tax 

     Net (loss) 

     Diluted (loss) income 

     EBITDA 

    and other expense

     income 

     per share 

    Three months ended

    Three months ended

    Three months ended

    Three months ended

    September 30, 

    September 30, 

    September 30, 

    September 30, 

    In millions, except per share amounts

    2025

    2024

    2025

    2024

    2025

    2024

    2025

    2024


    Net loss

    $         (11)

    $         (17)

    $         (11)

    $         (17)

    $      (0.06)

    $      (0.10)

    Net income attributable to noncontrolling interests

    (14)

    (16)

    (14)

    (16)

    (0.08)

    (0.09)


    Net loss attributable to Huntsman Corporation

    (25)

    (33)

    (25)

    (33)

    (0.14)

    (0.19)

    Interest expense, net from continuing operations

    20

    21


    Income tax expense from continuing operations

    3

    39

    $           (3)

    $         (39)


    Depreciation and amortization from continuing operations

    73

    70


    Business acquisition and integration expenses and purchase accounting inventory adjustments

    1

    1

    0.01

    Income tax settlement related to U.S. Tax Reform Act

    5

    5

    0.03

    EBITDA / Loss from discontinued operations

    1

    12

     N/A 

     N/A 

    1

    12

    0.01

    0.07

    Loss on sale of business/assets

    2

    1

    3

    2

    4

    0.01

    0.02

    Fair value adjustments to Venator investment, net and other tax matter adjustments

    (5)

    (5)

    (0.03)

    Certain legal and other settlements and related expenses, net

    11

    2

    13

    0.08

    Amortization of pension and postretirement actuarial losses

    8

    9

    (2)

    2

    6

    11

    0.03

    0.06

    Restructuring, impairment and plant closing and transition costs

    12

    6

    (1)

    3

    11

    9

    0.06

    0.05


    Adjusted (1)

    $          94

    $        131

    $           (6)

    $         (23)

    (5)

    17

    $      (0.03)

    $       0.10


    Adjusted income tax expense(1)

    6

    23


    Net income attributable to noncontrolling interests

    14

    16



    Adjusted pre-tax income (1)

    $          15

    $          56



    Adjusted effective tax rate (3)

    40 %

    41 %



    Effective tax rate

    (43 %)

    115 %



     Income tax 

     Net (loss) 

     Diluted (loss) income 

     EBITDA 

    and other expense

     income 

     per share 

    Nine months ended

    Nine months ended

    Nine months ended

    Nine months ended

    September 30, 

    September 30, 

    September 30, 

    September 30, 

    In millions, except per share amounts

    2025

    2024

    2025

    2024

    2025

    2024

    2025

    2024


    Net loss

    $       (145)

    $           (2)

    $       (145)

    $           (2)

    $      (0.84)

    $      (0.01)

    Net income attributable to noncontrolling interests

    (43)

    (46)

    (43)

    (46)

    (0.25)

    (0.27)


    Net loss attributable to Huntsman Corporation

    (188)

    (48)

    (188)

    (48)

    (1.09)

    (0.28)

    Interest expense, net from continuing operations

    60

    60


    Income tax expense from continuing operations

    25

    32

    $         (25)

    $         (32)


    Income tax expense (benefit) from discontinued operations(3)

    1

    (8)


    Depreciation and amortization from continuing operations

    214

    214


    Business acquisition and integration (gain) expenses and purchase accounting inventory adjustments

    (5)

    21

    (16)

    (5)

    5

    (0.03)

    0.03

    Income tax settlement related to U.S. Tax Reform Act

    5

    5

    0.03

    EBITDA / Loss from discontinued operations(3)

    20

    N/A

    N/A

    1

    12

    0.01

    0.07

    Establishment of significant deferred tax asset valuation allowances, net

    1

    1

    0.01

    Loss on sale of business/assets

    2

    1

    3

    2

    4

    0.01

    0.02

    Fair value adjustments to Venator investment, net and other tax matter adjustments

    (12)

    2

    (10)

    (0.06)

    Certain legal and other settlements and related (income) expenses, net

    (32)

    13

    7

    1

    (25)

    14

    (0.14)

    0.08

    Amortization of pension and postretirement actuarial losses

    22

    25

    (4)

    1

    18

    26

    0.10

    0.15

    Restructuring, impairment and plant closing and transition costs

    141

    25

    (3)

    (3)

    138

    22

    0.80

    0.13


    Adjusted (1)

    $        240

    $        343

    $         (24)

    $         (39)

    (58)

    30

    $      (0.34)

    $       0.17


    Adjusted income tax expense(1)

    24

    39


    Net income attributable to noncontrolling interests

    43

    46



    Adjusted pre-tax income (1)

    $            9

    $        115



    Adjusted effective tax rate (4)

    267 %

    34 %



    Effective tax rate

    (21 %)

    76 %



    N/M = not meaningful


    N/A = not applicable


    See end of press release for footnote explanations.


     






















    Table 5 – Balance Sheets


    September 30, 

    December 31,

    In millions

    2025

    2024


    Cash

    $               468

    $               340

    Accounts and notes receivable, net

    768

    725

    Inventories

    836

    917

    Prepaid expenses

    57

    114

    Other current assets

    53

    29

    Property, plant and equipment, net

    2,475

    2,493

    Other noncurrent assets

    2,425

    2,496

    Total assets

    $            7,082

    $            7,114


    Accounts payable

    $               688

    $               770

    Other current liabilities

    535

    470

    Current portion of debt

    378

    325

    Long-term debt

    1,630

    1,510

    Other noncurrent liabilities

    850

    876

    Huntsman Corporation stockholders’ equity

    2,766

    2,959

    Noncontrolling interests in subsidiaries

    235

    204

    Total liabilities and equity

    $            7,082

    $            7,114

     














    Table 6 – Outstanding Debt 


    September 30, 

    December 31,

    In millions

    2025

    2024


    Debt:


    Revolving credit facility

    $               366

    $                  –

    Senior notes

    1,488

    1,799

    Accounts receivable programs

    124

    Variable interest entities

    9

    16

    Other debt

    21

    20

    Total debt – excluding affiliates

    2,008

    1,835


    Total cash

    468

    340

    Net debt – excluding affiliates (4)

    $            1,540

    $            1,495


    See end of press release for footnote explanations.


     


























    Table 7 – Summarized Statements of Cash Flows


    Three months ended

    Nine months ended

    September 30, 

    September 30, 

    In millions

    2025

    2024

    2025

    2024


    Total cash at beginning of period

    $            399

    $            335

    $            340

    $            540


    Net cash provided by operating activities from continuing operations

    200

    134

    221

    126

    Net cash used in operating activities from discontinued operations

    (4)

    (5)

    (8)

    (16)

    Net cash used in investing activities

    (42)

    (7)

    (74)

    (87)

    Net cash used in financing activities

    (83)

    (129)

    (14)

    (231)

    Effect of exchange rate changes on cash

    (2)

    2

    3

    (2)


    Total cash at end of period

    $            468

    $            330

    $            468

    $            330


    Free cash flow from continuing operations (2) :


    Net cash provided by operating activities from continuing operations

    $            200

    $            134

    $            221

    $            126

    Capital expenditures

    (43)

    (41)

    (116)

    (133)


    Free cash flow from continuing operations (2)

    $            157

    $              93

    $            105

    $              (7)


    Supplemental cash flow information:


    Cash paid for interest

    $              (5)

    $             (14)

    $             (49)

    $             (55)

    Cash paid for income taxes

    (18)

    (16)

    (79)

    (60)

    Cash paid for restructuring and integration

    (7)

    (3)

    (18)

    (26)

    Cash paid for pensions

    (9)

    (9)

    (25)

    (26)

    Depreciation and amortization from continuing operations

    73

    70

    214

    214


    Change in primary working capital:


    Accounts and notes receivable

    $              37

    $              58

    $             (26)

    $             (72)

    Inventories

    55

    (66)

    114

    (137)

    Accounts payable

    (9)

    (1)

    (103)

    21

    Total change in primary working capital

    $              83

    $              (9)

    $             (15)

    $           (188)


    See end of press release for footnote explanations.


     












    Footnotes


    (1)

    We use adjusted EBITDA to measure the operating performance of our business and for planning and evaluating the performance of our business segments.  We provide adjusted net income (loss) because we feel it provides meaningful insight for the investment community into the performance of our business.  We believe that net income (loss) is the performance measure calculated and presented in accordance with generally accepted accounting principles in the U.S. (“GAAP”) that is most directly comparable to adjusted EBITDA and adjusted net income (loss).  Additional information with respect to our use of each of these financial measures follows:


    Adjusted EBITDA, adjusted net income (loss) and adjusted diluted income (loss) per share, as used herein, are not necessarily comparable to other similarly titled measures of other companies.


    Adjusted EBITDA is computed by eliminating the following from net income (loss):  (a) net income attributable to noncontrolling interests; (b) interest expense, net; (c) income taxes; (d) depreciation and amortization; (e) amortization of pension and postretirement actuarial losses; (f) restructuring, impairment and plant closing and transition costs; and further adjusted for certain other items set forth in the reconciliation of net income (loss) to adjusted EBITDA in Table 4 above. 


    Adjusted net income (loss) and adjusted diluted income (loss) per share are computed by eliminating the after tax impact of the following items from net income (loss): (a) net income attributable to noncontrolling interests; (b) amortization of pension and postretirement actuarial losses; (c) restructuring, impairment and plant closing and transition costs; and further adjusted for certain other items set forth in the reconciliation of net income (loss) to adjusted net income (loss) in Table 4 above.  The income tax impacts, if any, of each adjusting item represent a ratable allocation of the total difference between the unadjusted tax expense and the total adjusted tax expense, computed without consideration of any adjusting items using a with and without approach.


    We may disclose forward-looking adjusted EBITDA because we cannot adequately forecast certain items and events that may or may not impact us in the near future, such as business acquisition and integration expenses and purchase accounting inventory adjustments, net, certain legal and other settlements and related expenses, gains on sale of businesses/assets and certain tax only items, including tax law changes not yet enacted. Each of such adjustment has not yet occurred, is out of our control and/or cannot be reasonably predicted. In our view, our forward-looking adjusted EBITDA represents the forecast net income on our underlying business operations but does not reflect any adjustments related to the items noted above that may occur and can cause our adjusted EBITDA to differ.


    (2)

    We believe free cash flow is an important indicator of our liquidity as it measures the amount of cash we generate. Management internally uses free cash flow measure to: (a) evaluate our liquidity, (b) evaluate strategic investments, (c) plan stock buyback and dividend levels and (d) evaluate our ability to incur and service debt. Free cash flow is defined as net cash provided by (used in) operating activities less capital expenditures. Free cash flow is not a defined term under U.S. GAAP, and it should not be inferred that the entire free cash flow amount is available for discretionary expenditures.


    (3)

    We believe the adjusted effective tax rate provides improved comparability between periods through the exclusion of certain items that management believes are not indicative of the businesses’ operational profitability and that may obscure underlying business results and trends. In our view, effective tax rate is the performance measure calculated and presented in accordance with U.S. GAAP that is most directly comparable to adjusted effective tax rate. The reconciliation of historical adjusted effective tax rate and effective tax rate is set forth in Table 4 above. Please see the reconciliation of our net income to adjusted net income in Table 4 for details regarding the tax impacts of our non-GAAP adjustments.


    (4)

    Net debt is a measure we use to monitor how much debt we have after taking into account our total cash. We use it as an indicator of our overall financial position, and calculate it by taking our total debt, including the current portion, and subtracting total cash.

    About Huntsman:

    Huntsman Corporation is a publicly traded global manufacturer and marketer of differentiated and specialty chemicals with 2024 revenues of approximately $6 billion from our continuing operations. Our chemical products number in the thousands and are sold worldwide to manufacturers serving a broad and diverse range of consumer and industrial end markets. We operate more than 60 manufacturing, R&D and operations facilities in approximately 25 countries and employ approximately 6,300 associates within our continuing operations. For more information about Huntsman, please visit the company’s website at  www.huntsman.com

    Social Media:

    X : http://www.x.com/Huntsman_Corp
    Facebook
    : www.facebook.com/huntsmancorp
    LinkedIn
    : www.linkedin.com/company/huntsman

    Forward-Looking Statements: 

    This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include statements concerning our plans, objectives, goals, strategies, future events, future revenue or performance, capital expenditures, financing needs, plans or intentions relating to acquisitions, divestitures or strategic transactions, business trends and any other information that is not historical information. When used in this press release, the words “estimates,” “expects,” “anticipates,” “likely,” “projects,” “outlook,” “plans,” “intends,” “believes,” “forecasts,” or future or conditional verbs, such as “will,” “should,” “could” or “may,” and variations of such words or similar expressions are intended to identify forward-looking statements. These forward-looking statements, including, without limitation, management’s examination of historical operating trends and data, are based upon our current expectations and various assumptions and beliefs. In particular, such forward-looking statements are subject to uncertainty and changes in circumstances and involve risks and uncertainties that may affect the Company’s operations, markets, products, prices and other factors as discussed in the Company’s filings with the Securities and Exchange Commission (the “SEC”). Significant risks and uncertainties may relate to, but are not limited to, high energy costs in Europe, inflation and high capital costs, geopolitical instability, volatile global economic conditions, cyclical and volatile product markets, disruptions in production at manufacturing facilities, reorganization or restructuring of the Company’s operations, including any delay of, or other negative developments affecting the ability to implement cost reductions and manufacturing optimization improvements in the Company’s businesses and to realize anticipated cost savings, and other financial, operational, economic, competitive, environmental, political, legal, regulatory and technological factors. Any forward-looking statement should be considered in light of the risks set forth under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, which may be supplemented by other risks and uncertainties disclosed in any subsequent reports filed or furnished by the Company from time to time. All forward-looking statements apply only as of the date made. Except as required by law, the Company undertakes no obligation to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events.

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/huntsman-announces-third-quarter-2025-earnings-302607844.html

    SOURCE Huntsman Corporation

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  • Regional airline Eastern Airways enters administration

    Regional airline Eastern Airways enters administration

    UK regional airline Eastern Airways has entered administration after the majority of its 330 staff were made redundant last week.

    The airline had operated across the UK, Ireland and Europe, and ran services supported by the Scottish government for people in the northernmost point of mainland UK.

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    The company had filed a notice of intention to appoint an administrator on 27 October after the Civil Aviation Authority announced all of its flights had been cancelled.

    Launched in 1997, Eastern is one of the UK’s last remaining regional airlines and is based at Humberside Airport in North Lincolnshire.

    But the airline has faced financial challenges since the Covid pandemic, in part due to falling passenger numbers.

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    It has run a weekday service between Wick John O’Groats Airport and Aberdeen, which is seen as vital for people living in the most northerly point on mainland UK.

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