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  • Long-Term CARTITUDE-4 Data Point to Potential Cure Fraction With Cilta-Cel in Standard-Risk R/R Myeloma

    Long-Term CARTITUDE-4 Data Point to Potential Cure Fraction With Cilta-Cel in Standard-Risk R/R Myeloma

    Long-term data from the phase 3 CARTITUDE-4 trial (NCT04181827) demonstrated that patients with standard-risk relapsed/refractory multiple myeloma experienced low rates of disease progression when treated with ciltacabtagene autoleucel (cilta-cel; Carvykti), suggesting a potential cure fraction in this patient population.1

    Findings presented at the 2025 ASH Annual Meeting and Exposition showed that in the standard-risk, as-treated patient population from CARTITUDE-4 (n = 59), cilta-cel elicited a 30-month progression-free survival (PFS) rate of 80.5% and a 30-month overall survival (OS) rate of 87.3%. When expanding this population to include patients harboring 1q gains or amplifications (n = 105), the 30-month PFS and OS rates were 71.7% and 86.1%, respectively.

    Notably, 86% of patients with standard-risk cytogenetics (n = 51/59) were alive and progression-free 1 year after treatment; the respective 30-month PFS and OS rates for this subgroup were 93.1% and 93.7%. Furthermore, 81% of evaluable patients at 1 year (n = 26/32) achieved a minimal residual disease (MRD)–negative complete response (CR). All of these patients remained progression-free at 30 months.

    “We believe that low rates of progression seen in these [standard-risk] patients are indicative of a potential cure fraction, which will be further defined with additional follow-up,” lead study author Luciano Costa, MD, said in a presentation of the data.

    Costa is the Mary and Bill Battle Professor of Multiple Myeloma and director of the Multiple Myeloma Research and Treatment Program at The University of Alabama at Birmingham.

    Outcomes With Cilta-Cel in Standard-Risk R/R Myeloma in CARTITUDE-4

    1. Low rates of disease progression with cilta-cel in patients with relapsed/refractory multiple myeloma with standard-risk cytogenetics suggest a potential cure fraction in this population.
    1. At 30 months, the PFS and OS rates with cilta-cel in the standard-risk, as-treated patient population from CARTITUDE-4 were 80.5% and 87.3%, respectively.
    1. When patients harboring only 1q gain/amplification were included in the standard-risk group, the respective 30-month PFS and OS rates were 71.7% and 86.1%.

    What data were previously reported from CARTITUDE-4?

    In April 2024, the FDA approved cilta-cel for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and who are refractory to lenalidomide (Revlimid), based on prior data from CARTITUDE-4.2 The CAR T-cell therapy was initially approved by the FDA in February 2022 for the treatment of adult patients with relapsed/refractory multiple myeloma following 4 or more prior lines of therapy, including a PI, an IMiD, and an anti-CD38 monoclonal antibody, based on findings from the phase 1/2 CARTITUDE-1 trial (NCT03548207).3

    In CARTITUDE-4, at a median follow-up of 33.6 months (range, 0.1-45.0), patients with standard-risk cytogenetics treated with cilta-cel (n = 69) achieved a 30-month PFS rate of 71.0% compared with 43.2% for those treated with standard-of-care (SOC) therapy (n = 70; HR, 0.43).1,4 The 30-month OS rates were 79.7% and 69.6%, respectively (HR, 0.62).1 In patients with high-risk cytogenetics, the 30-month PFS rates were 52.3% for cilta-cel (n = 123) vs 17.5% for SOC (n = 123; HR, 0.38). The 30-month OS rates in the high-risk subgroup were 75.5% and 62.1%, respectively (HR, 0.54).

    How was the CARTITUDE-4 trial designed?

    Investigators enrolled patients at least 18 years of age with relapsed/refractory multiple myeloma who had received 1 to 3 prior lines of therapy, including a PI and IMiD, and were refractory to lenalidomide. Patients needed to have an ECOG performance status of 0 or 1, and prior treatment with CAR T-cell therapy or a BMCA-targeted therapy was not allowed.

    Patients were randomly assigned 1:1 to receive cilta-cel or SOC therapy comprising pomalidomide (Pomalyst) plus bortezomib (Velcade) and dexamethasone or daratumumab (Darzalex) plus pomalidomide and dexamethasone.

    PFS served as the trial’s primary end point, and secondary end points comprised CR or better rate, overall response rate (ORR), MRD-negativity rate, OS, and safety.

    For the current long-term analysis of CARTITUDE-4, the as-treated population included patients with standard-risk cytogenetics per study protocol, along with those harboring only 1q gains or amplifications. Investigators also examined long-term outcomes for patients with standard-risk cytogenetics, including those with 1q gains or amplifications, treated in CARTITUDE-1.

    In the CARTITUDE-4 as-treated population, including those with 1q gain/amplification, the median age was 62.0 years (range, 27-78), and 52.4% of patients were male. International Staging System (ISS) stages included I (71.4%), II (23.8%), and III (4.8%). Patients received 1 prior line of therapy (31.4%), 2 prior lines of therapy (40.0%), or 3 prior lines of therapy (28.6%), with a median of 2 prior lines of therapy (range, 1-3). All patients were refractory to lenalidomide, 20.0% were refractory to daratumumab, and 10.5% were triple-class refractory. Notably, 5.7% of patients had soft tissue plasmacytomas.

    In the CARTITUDE-1 standard-risk population, which included those with 1q gain/amplification (n = 68), the median age was 60.5 years (range, 43-78), and 57.4% were male. Patients had ISS stage I disease (58.8%), stage II disease (22.1%), or stage III disease (19.1%). Notably, 16.2% of patients in this study received 3 prior lines of therapy, and the remainder were administered at least 4 prior lines of therapy; the median was 6 prior lines of therapy (range, 3-18). In the CARTITUDE-1 population, 77.9% were refractory to lenalidomide, 97.1% were refractory to daratumumab, and 89.7% were triple-class refractory. Soft tissue plasmacytomas were reported in 16.2% of patients at baseline.

    What other outcomes were reported at this year’s ASH Annual Meeting?

    Findings from the analysis also showed that the ORR was 100% for patients with standard-risk cytogenetics without 1q gain/amplification treated with cilta-cel in CARTITUDE-4, including a CR or better rate of 90%. When including patients with 1q gain/amplification, the ORR remained at 100%, with a CR or better rate of 92%. In the CARTITUDE-1 population, the ORR was 94.1%, with a CR or better rate of 82%.

    In the CARTITUDE-1 group, the 30-month PFS and OS rates were 59.9% and 70.6%, respectively.

    In the CARTITUDE-4 standard-risk subgroup without 1q gain/amplification, the safety profiled of cilta-cel was consistent with the overall study population. Non-hematologic serious adverse effects occurred in 52.5% of patients, and 28.8% had grade 3/4 infections. Any-grade cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome were reported in 74.6% and 1.7% of patients, respectively. Additionally, 6.8% of patients had cranial nerve palsy, and no patients had immune effector cell–parkinsonism.

    Secondary primary malignancies were reported in 13.6% of patients in the CARTITUDE-4 standard-risk subgroup, including cutaneous/non-invasive malignancies (n = 4) and non-cutaneous/invasive malignancies (n = 4). No secondary hematologic malignancies were reported.

    The non-relapsed mortality rate was 10.2%; this included 4 deaths reported in the first year due to COVID-19 (n = 2), subdural hematoma (n = 1), and multiple organ dysfunction (n = 1). The 2 deaths that occurred beyond 1 year were attributed to gastric adenocarcinoma (n = 1) and angiosarcoma (n = 1).

    Disclosures: Costa reported receiving honoraria from AbbVie, Pfizer, AstraZeneca, Johnson & Johnson, Regeneron, Amgen, Sanofi, Bristol Myers Squibb, Adaptive Biotechnologies, and Genentech; consultancy (including expert testimony) for Caribou, Regeneron, Sanofi, Pfizer, Genentech, Johnson & Johnson, Bristol Myers Squibb, AbbVie, and Amgen; and receiving research funding from Genentech, AstraZeneca, AbbVie, Pfizer, Bristol Myers Squibb, Johnson & Johnson, Caribou, and Amgen.

    References

    1. Costa L, Oriol A, Dytfield D, et al. Long-term progression-free survival benefit with ciltacabtagene autoleucel in standard-risk relapsed/refractory multiple myeloma. Blood. 2025;146(suppl 1):94. doi:10.1182/blood-2025-94
    2. Carvykti is the first and only BCMA-targeted treatment approved by the US FDA for patients with relapsed or refractory multiple myeloma who have received at lease one prior line of therapy. News release. Johnson & Johnson. April 5, 2024. Accessed December 6, 2024. https://www.jnj.com/media-center/press-releases/carvykti-is-the-first-and-only-bcma-targeted-treatment-approved-by-the-u-s-fda-for-patients-with-relapsed-or-refractory-multiple-myeloma-who-have-received-at-least-one-prior-line-of-therapy
    3. FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma. February 28, 2022. Accessed December 6, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma
    4. Sidana S, Martinez-Lopez J, Khan AM, et al. Ciltacabtagene autoleucel (cilta-cel) vs standard of care (SOC) in patients (pts) with relapsed/refractory multiple myeloma (MM): CARTITUDE-4 survival subgroup analyses. J Clin Oncol. 2025;43(suppl 16):7539. doi:10.1200/JCO.2025.43.16_suppl.7539

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  • Boeing says Trump’s equity stake plan doesn’t apply to big US defense firms

    Boeing says Trump’s equity stake plan doesn’t apply to big US defense firms

    SIMI VALLEY, California, Dec 6 (Reuters) – U.S. President Donald Trump’s plan to take government equity stakes in strategic industries doesn’t apply to major defense firms, the head of Boeing’s defense unit said on Saturday, in contrast to previous comments by a senior government official.

    “It really only applies on the supply chain, particularly for the smaller companies coming through where that might be a way forward for them to get some equity,” Steve Parker, Chief Executive Officer of Boeing Defense, Space & Security, said on a panel at the Reagan National Defense Forum, an annual industry event in Simi Valley, California.

    Sign up here.

    “I don’t think it really applies to the Primes,” Parker added, referring to big legacy defense contractors like Boeing, Lockheed Martin, RTX and Northrop Grumman.

    In August, U.S. Commerce Secretary Howard Lutnick said the Trump administration was weighing equity stakes in major defense contractors, including Lockheed Martin, a move that sent shares of Lockheed, Boeing and other defense firms higher.
    This year, the Trump administration has taken equity stakes in chipmaker Intel and rare earths company MP Materials, in an effort to prioritize national security in critical sectors where China has become increasingly dominant. Trump has said the government will take stakes in more companies.

    Reporting by Mike Stone and Joe Brock; Editing by Chizu Nomiyama and Deepa Babington

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

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  • Kite Announces New Data for Pivotal iMMagine 1 Study at ASH 2025, Highlighting Anito cel’s Opportunity in Relapsed or Refractory Multiple Myeloma

    – 96% Overall Response Rate, 74% Stringent Complete Response/Complete Response, and 95% Minimal Residual Disease Negativity Observed at a Median 15.9-months of Follow-up, with Responses Continuing to Deepen Over Time –

    – Observed Safety Profile is Predictable and Manageable to Date; No Delayed Neurotoxicities or Immune Effector Cell-Associated Enterocolitis across Phase 1 and 2 (iMMagine-1) Studies –

    – Data from Investigational Agent Anito-cel Support Planned 2026 Launch in the U.S. –

    SANTA MONICA, Calif.–(BUSINESS WIRE)–
    Kite, a Gilead Company (Nasdaq: GILD), and its partner Arcellx, today announced new positive data from its pivotal iMMagine-1 Phase 2 study of anitocabtagene autoleucel (anito-cel), an investigational agent, which continues to show clinically meaningful deep and durable efficacy with predictable and manageable safety observed to date in relapsed or refractory multiple myeloma (RRMM) patients who had received at least three prior lines of therapy. These new findings from the ongoing study will be shared in an oral presentation (Abstract #256) today at 2:45 PM ET during the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.

    “These data are compelling and are an important advancement for patients living with multiple myeloma,” said Dr. Krina Patel, lead investigator, Associate Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. “I am encouraged by the depth of responses in the iMMagine-1 study. For clinicians, we rely on therapies that deliver continued meaningful efficacy, a predictable safety profile, and reliable manufacturing. Anito-cel demonstrates that it could become a significant new treatment option in our efforts to improve outcomes for patients with multiple myeloma.”

    Data from an October 7, 2025 cutoff date, including 117 patients treated with anito-cel, who were followed for a median of 15.9 months, showed an independent review committee (IRC)-assessed overall response rate (ORR) of 96%, with 74% achieving a stringent complete response or complete response (sCR or CR) per International Myeloma Working Group (IMWG) criteria. 102 of 117 patients (87%) were triple refractory, 48 of 117 patients (41%) were penta refractory, 21 of 117 patients (18%) had extramedullary disease, and 47 of 117 patients (40%) had high risk cytogenetics. For many in this heavily pre-treated population, responses began quickly, often within one month. Median time to best response was 4.8 months and median time to sCR or CR was 3.2 months. Of the 96 patients evaluable for minimal residual disease (MRD) testing, 91 (95%) achieved MRD negativity at a median time of 1 month, meaning no cancer cells could be detected even with highly sensitive tests (≤10-5 sensitivity).

    The progression-free survival (PFS) rates were 82.1% at 12 months, 67.4% at 18 months and 61.7% at 24 months, meaning many patients were still alive and free from cancer progression at those timepoints. The overall survival (OS) rates showed that a significant majority of patients remained alive, with 94% at 12 months, 88% at 18 months and 83% at 24 months. The median PFS and OS have not yet been reached, suggesting sustained and ongoing benefit for a majority of patients.

    Importantly, no delayed (non-ICANS) neurotoxicities, including no Parkinsonism, no cranial nerve palsies, no Guillain-Barré syndrome, and no immune effector cell-associated enterocolitis, have been observed to date, with all patients dosed at least 12 months prior to the cutoff. In an exploratory study sponsored by Kite (Abstract #503), characterization of CD4+ CAR T cell subtypes provide further mechanistic hypotheses supporting the neurologic tolerability profile of anito-cel.

    “For multiple myeloma patients in advanced treatment stages, effective options are critical as resistance to treatment grows,” said Cindy Perettie, Executive Vice President, Kite. “The deep, durable responses seen with iMMagine-1, combined with a predictable and manageable safety profile and rapid and reliable manufacturing, highlight anito-cel’s potential to redefine care. Together with Arcellx, our goal is to deliver a differentiated, one-time treatment option in 2026 that may reduce patient burden and improve access, including in outpatient and community oncology settings.”

    Observed side effects were generally consistent with past readouts. Cytokine release syndrome (CRS) was observed in 86% of patients but was generally mild and manageable. In fact, 83% of patients in the study experienced no CRS or Grade 1 CRS (fever only). Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 8% of patients, with only one Grade 3 case and all other cases Grade 2 or lower. The most common hematologic adverse events noted during treatment were low white blood cell counts (neutropenia) in 71% of patients, low red blood cells (anemia) in 28%, and low platelets (thrombocytopenia) in 26%. Grade 3 or higher infections occurred in 9% of patients.

    Additional research presented at ASH provided further insights into CAR T-cell therapies, detailing anito-cel’s mechanism and factors influencing treatment outcomes.

    Preclinical research (Abstract #7644) shows that anito-cel’s D-Domain binder interacts with BCMA by binding and releasing quickly. Relative to a comparator CAR T-cell therapy in preclinical models, this transient interaction with cancer cells may be associated with decreased inflammation while maintaining the ability to effectively kill cancer cells. Additionally, the abstract shows anito-cel retains its ability to target cancer cells with altered BCMA expression after previous treatments, demonstrating the potential for anito-cel to maintain efficacy in patients previously exposed to BCMA-targeting therapies. Further research, including crystallography and epitope mapping, is ongoing to provide more detail on this mechanism.

    About anitocabtagene autoleucel (anito-cel)

    Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

    About Multiple Myeloma

    Multiple myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. MM is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple comorbidities and toxicities that can quickly escalate and become life-endangering.

    About iMMagine-1

    iMMagine-1 is a Phase 2 registrational, pivotal open-label study of anito-cel in patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior regimens of systemic therapy including proteasome inhibitor, immunomodulatory drugs (IMiD) and anti-CD38 antibody and are refractory to the last line of therapy.

    The trial assessed both safety and efficacy in 117 patients receiving a single infusion of anito-cel (target dose of 115×106 CAR+ viable T cells). Efficacy was assessed monthly for the first 6 months, then quarterly up to 2 years, or upon patient relapse. Long-term safety data will be collected under a separate long-term follow-up study for up to 15 years.

    The primary endpoint is overall response rate (ORR) per International Myeloma Working Group (IMWG) criteria, as assessed by an independent review committee. Secondary endpoints include complete response rate (CR/sCR), progression-free survival, overall survival, duration of response, minimal residual disease negativity and safety.

    About Gilead and Kite Oncology

    Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer.

    About Arcellx and Kite Collaboration

    Arcellx and Kite, a Gilead Company, formed a global strategic collaboration to co-develop and co-commercialize anito-cel for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Anito-cel is currently being developed in a Phase 2 registrational study and a Phase 3 pivotal study for RRMM, iMMagine-3. Kite and Arcellx will jointly commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States.

    Forward-Looking Statements

    This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving anito-cel (such as iMMagine-1); uncertainties relating to regulatory applications and related filing and approval timelines, including pending or potential applications for indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead and Kite may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.

    Gilead, the Gilead logo, Kite, and the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies

    For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

    For more information on Kite, please visit the company’s website at www.kitepharma.com. Follow Kite on social media on X/Twitter (@KitePharma) and LinkedIn (Kite-Pharma).


    Source: Gilead Sciences, Inc.

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  • Reassessing Valuation After ESOP Offering, AI Storage Tailwinds, and Capital Return Moves

    Reassessing Valuation After ESOP Offering, AI Storage Tailwinds, and Capital Return Moves

    Western Digital (WDC) just put a fresh spotlight on its stock by filing a roughly $1.11 billion shelf registration tied to an 8 million share ESOP offering, which blends potential dilution with stronger employee alignment.

    See our latest analysis for Western Digital.

    The ESOP filing lands on top of an already powerful move, with the share price at $168.89 after a 1 year to date share price return of about 173 percent and a 1 year total shareholder return above 215 percent. This suggests momentum is still building as investors reward Western Digital’s AI centric repositioning and capital returns.

    If this kind of AI driven surge has your attention, it could be a good moment to see what else is gaining traction across high growth tech and AI stocks.

    But with shares up more than 170 percent year to date and trading only modestly below Wall Street targets, is Western Digital still undervalued on its AI runway, or are markets already pricing in years of growth ahead?

    With Western Digital closing at $168.89 versus a narrative fair value of $181.43, the prevailing view still leans toward upside driven by AI centric demand.

    The explosive increase in unstructured data generated by AI applications, Agentic AI, and cloud-based services across industries is driving unprecedented storage needs. Western Digital’s deep integration with leading hyperscalers (e.g., all top 5 with firm POs/LTAs covering the next 12 to 18 months) positions the company to benefit from secular demand, directly fueling higher long-term revenue growth.

    Read the complete narrative.

    Curious how steady, not hyperbolic, growth assumptions can still justify a higher valuation multiple than today? The narrative quietly bakes in richer margins, rising earnings power, and a future PE that leans closer to established tech leaders than cyclical hardware names. Want to see the exact earnings and revenue path it is betting on?

    Result: Fair Value of $181.43 (UNDERVALUED)

    Have a read of the narrative in full and understand what’s behind the forecasts.

    However, concentrated reliance on a few hyperscalers, along with the risk that alternative storage technologies outpace HDD advances, could quickly unwind today’s optimistic assumptions.

    Find out about the key risks to this Western Digital narrative.

    Step back from the narrative fair value, and Western Digital looks pricey on a simple earning based snapshot. Its 22.2x earnings multiple sits above peers at 20.7x, yet still below a 33.4x fair ratio. This leaves investors weighing the potential for a rerating to the upside against the risk of sentiment cooling.

    See what the numbers say about this price — find out in our valuation breakdown.

    NasdaqGS:WDC PE Ratio as at Dec 2025

    If this outlook does not fully reflect your view, or you prefer hands on research, you can build a personalized storyline in minutes, Do it your way.

    A good starting point is our analysis highlighting 3 key rewards investors are optimistic about regarding Western Digital.

    Before you move on, review a curated set of opportunities that may complement your current Western Digital thesis.

    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

    Companies discussed in this article include WDC.

    Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

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  • Elranatamab Plus Iberdomide Shows Early Efficacy in R/R Multiple Myeloma

    Elranatamab Plus Iberdomide Shows Early Efficacy in R/R Multiple Myeloma

    The combination of elranatamab-bcmm (Elrexfio) and iberdomide (CC-220) demonstrated early efficacy in the form of responses with safety that aligned with known toxicities of the individual agents in patients with relapsed or refractory multiple myeloma, according to data from part 1 of the phase 1b MagnetisMM-30 trial (NCT06215118) presented during the 2025 ASH Annual Meeting.1

    At a median follow-up of 7.8 months (range, 0.7-11.3), the doublet induced an objective response rate (ORR) of 95.5% (95% CI, 77.2%-99.9%) in all evaluable patients (n = 22), which included a complete response (CR) or better rate of 45.5% and a very good partial response (VGPR) or better rate of 77.3%. Moreover, responses occurred early, with a median time to response of 1.4 months (range, 0.5-2.7).

    When broken down by dose level, in those who received elranatamab at 76 mg once weekly plus 1.0 mg of iberdomide (DL1; n = 13), the ORR with the combination was 92.3% (95% CI, 64.0%-99.8%) at a median follow-up of 9.4 months (range, 0.7-11.3); the CR or better rate was 46.2% and the VGPR or better rate was 69.2%. In patients given elranatamab at 76 mg once every 2 weeks plus 1.0 mg of iberdomide (DL-1; n = 9), the ORR achieved with the doublet was 100.0% (95% CI, 66.4%-100.0%) with 44.4% of patients experiencing a CR or better and 88.9% of patients experiencing a VGPR or better. The median follow-up for this group was 5.2 months (range, 4.5-6.4).

    When examining ORR by cytogenetic risk, those with standard risk (n = 11) experienced a confirmed ORR of 100% (95% CI, 71.5%-100.0%) by investigator assessment, which included CR or better and VGPR or better rates of 36.4% and 72.7%, respectively. In those determined to have high cytogenetic risk (n = 9), the ORR with the combination was slightly lower, at 88.9% (95% CI, 51.8%-99.7%); in this group, the CR or better rate was 44.4% and the VGPR or better rate was 77.8%. Two patients were noted to have missing cytogenetic risk data; these patients both experienced a CR with the regimen.

    In evaluable patients (n = 17), 4 dose-limiting toxicities (DLTs) were observed; 2 occurred at DL1 (grade 3 anorexia and grade 4 neutropenia) and 2 at DL-1 (grade 3 febrile neutropenia and grade 4 neutropenia). The most common treatment-emergent adverse effects (TEAEs) experienced with the regimen included hematologic effects, particularly neutropenia (n = 17, 77.3%); infections (n = 9, 40.9%); and cytokine release syndrome (CRS) (n = 15, 68.2%). Notably, most infections were grade 2 or lower as were all cases of CRS and immune effector cell–associated neurotoxicity syndrome (ICANS) that were reported.

    “[The data] demonstrate that the combination of elranatamab and iberdomide is effective and manageable in BCMA-naive patients with relapsed/refractory multiple myeloma,” Attaya Suvannasankha, MD, of Melvin and Bren Simon Comprehensive Cancer Center, Indiana University, in Indianapolis, Indiana, said in a presentation of the data. “Even with a median follow-up of just 7.8 months, the overall response rate of 95.5% and CR rate or better [rate] of 45.5% appears to favorably [compare with] the single-agent outcomes in a different population, as well as also some emerging combinations with CELMoDs.”

    What inspired the launch of the phase 1b MagnetisMM-30 study?

    Making Sense of MagnetisMM-30: Elranatamab Plus Iberdomide in R/R Multiple Myeloma

    • Early data from MagnetisMM-30 indicated that the combination of elranatamab and iberdomide induced an ORR of 95.5% with rapid, deep, and potentially durable responses in patients with BCMA-naive relapsed/refractory multiple myeloma.
    • The safety profile of the regimen was reported to be manageable, with expected toxicities such as neutropenia, infections, and low-grade CRS/ICANS aligning with known profiles of each agent.
    • The early results support the continued evaluation of the doublet in MagnetisMM-30, where part 2 will refine dosing to optimize the balance between efficacy and tolerability.

    In August 2023, the FDA granted accelerated approval to the bispecific BCMA-directed CD3 T-cell engager elranatamab for use in adult patients with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody.2 The decision was supported by data from the phase 2 MagnetisMM-3 trial (NCT04649359) in which the agent induced an ORR of 57.7% (95% CI, 47.3%-67.7%) in evaluable patients (n = 97), with 82% remaining in response for at least 9 months. Updated data showed an ORR of 61.0% with a CR or better rate of 37.4%, as well as a median progression-free survival of 17.2 months and a median overall survival of 24.6 months.3,4

    Suvannasankha added that iberdomide is an oral CELMoD that has been shown to lead to better immunomodulatory activity and antiproliferative and proapoptotic activity in myeloma cells compared with IMiDs.1 Preclinical data have shown that the agent promotes the activation and proliferation of T cells and leads to stronger T-cell engagement and better T-cell fitness, she added.

    “So, based on the complementary mechanism of action, it would be rational to think that the combination may improve efficacy—particularly in patients with relapsed/refractory multiple myeloma,” Suvannasankha said. “This provided a scientific rationale for the MagentisMM-30 study.”

    What is the design of the MagnetisMM-30 study?

    The phase 1b, open-label, multicenter, prospective study is comprised of 2 parts: the dose-escalation and dose-optimization portions of the research. The trial enrolled patients aged 18 years or older with multiple myeloma per International Myeloma Working Group criteria and who had an ECOG performance status ranging from 0 to 1. These patients had previously received 2 to 4 lines of therapy, including at least 1 IMiD and at least 1 PI, and were relapsed or refractory to their last line of therapy. “Of note, all patients were BCMA naive,” Suvannasankha said.

    Those who underwent stem cell transplant within 12 weeks of enrollment or who had active graft-vs-host disease were excluded, as were those with ongoing peripheral sensory or motor neuropathy that was grade 2 or higher or a history of peripheral motor neuropathy that was grade 3 or higher.

    “In all of the dose levels, patients would first receive the standard step-up dosing of subcutaneous elranatamab according to the approved protocol,” she explained. “Then, after they completed the step-up dosing, the combination would start.” For DL1, patients received elranatamab at 76 mg once weekly paired with iberdomide at 1.0 mg once daily for 21 days out of a 28-day cycle. For DL-1, the dose of elranatamab was reduced to 76 mg every 2 weeks and the iberdomide dose was the same.

    The primary end point for part 1 is DLTs during the DLT observation period. Key secondary end points include safety in the form of adverse effects (AEs) and laboratory abnormalities, ORR, CR rate, time-to-event end points, minimal residual disease negativity rate, and immunogenicity. Part 2 is designed to further examine the safety and preliminary efficacy of the combination at 2 dosing regimens.

    At the ASH Annual Meeting, Suvannasankha shared preliminary findings from part 1 of the trial.

    What should be known about the MagnetisMM-30 patient population?

    At a data cutoff date of September 19, 2025, a total of 22 patients who have been enrolled at centers throughout the United States, Canada, and Australia. The median patient age was 68.0 years (range, 46-83); 45.5% of patients were male, more than half (68.2%) were White, and 54.5% had an ECOG performance status of 1. Moreover, patients had stage I (22.7%), II (63.6%), or III (4.5%) disease by Revised International Staging System criteria.

    “Key characteristics also include 40.9% of patients with high-risk cytogenetics, 18.2% had extramedullary disease, 50% of patients were already triple-class refractory, [and] a high proportion, 77.3% of patients, had had high-dose chemotherapy and [prior] stem cell transplantation,” Suvannasankha noted. “Also, 86.4% were refractory to their prior line of therapy.”

    Of the 22 patients, 13 received elranatamab at DL1 and 9 received it at DL-1. In the DL1 group, 5 patients discontinued treatment due to an AE (n = 2), progressive disease (n = 2), or death (n = 1), which was noted to not be associated with study treatment. A total of 8 patients in the DL1 group were still receiving treatment at cutoff. In the DL-1 group, all patients were still receiving treatment.

    The relative dose intensity for elranatamab and iberdomide in the overall population was 78.2% (range, 33.3%-100.4%) and 74.3% (range, 36.1%-100.0%) respectively. Dose interruptions for elranatamab were required in 81.8% of patients; 81.8% of patients also required dose interruptions of iberdomide. Moreover, 54.5% of patients required dose reductions of iberdomide.

    “In comparing the DL-1 and the DL1, it was clear that elranatamab relative dose intensity according to plan, was better, suggesting a better safety profile and tolerability,” Suvannasankha said.

    What was learned about the toxicity profile of elranatamab plus iberdomide in this population of patients with relapsed/refractory multiple myeloma?

    Suvannasankha noted that 59.1% of patients were given granulocyte colony-stimulating factor at some point in their treatment course with the combination.

    Any-grade TEAEs occurred in all patients, and 86.4% of cases were grade 3 or 4 in severity. The most common TEAEs were neutropenia (any grade, 77.3%; grade 3/4, 72.7%), CRS (68.2%; 0%), fatigue (63.6%; 0%), diarrhea (50.0%; 0%), headache (45.5%; 0%), cough (45.5%; 0%), nausea (40.9%; 0%), injection site reaction (40.9%; 0%), decreased appetite (36.4%; 4.5%), anemia (31.8%; 13.6%), and lymphopenia (18.2%; 18.2%). Broken down further, in terms of CRS, 54.5% of cases were grade 1 and 13.6% were grade 2; grade 1 or 2 ICANS occurred in 4.5% and 4.5% of patients, respectively.

    Moreover, 40.9% of patients experienced any-grade infections; 2 cases were grade 3, with one patient experiencing gastroenteritis Escherichia coli and the other experiencing a skin infection. The most common infections included upper respiratory tract infection (27.3%), Candida infection (13.6%), and urinary tract infection (9.1%).

    What was learned about response and PFS with elranatamab plus iberdomide in myeloma?

    “It is clear that the responses occurred early and continue to deepen over time. Even with a short follow-up on the DL-1, there are already several patients who have, in fact, achieved complete remission. For the DL1 patients who achieved remission, [they] continue to sustain that remission,” Suvannasankha explained. “Patients who stopped therapy include those who had very early progression, who were not even able to start the combination and already passed away from progression of disease, patients who had pancreas cancer, and also patients who progressed and eventually died from the cancer. Two patients discontinued therapy for other reasons unrelated to progression, and they continue to enjoy remission.”

    What is next for MagnetisMM-30 and elranatamab plus iberdomide in this disease?

    The study is ongoing and continues to recruit patients for part 2. “[We] aim to incorporate a larger number of patients and also evaluate different dose and schedule of elranatamab and iberdomide to try to balance efficacy and toxicity,” Suvannasankha concluded.

    Disclosures: Suvannasankha serves in a consultancy role for Karyopharm, Bristol Myer Squibb, GlaxoSmithKline, Regeneron, Sanofi, Jannsen, and Janssen Oncology. Research funding was provided by Bristol Myers Squibb, Regeneron, GlaxoSmithKline, Pfizer, Janssen, Janssen Oncology, and Sutro.

    References

    1. 1.Suvannasankha A, Kaufman JL, Badros A, et al. Safety and efficacy of elranatamab in combination with iberdomide in patients with relapsed or refractory multiple myeloma: results from the phase 1b MagentisMM-30 trial. Presented at: 2025 ASH Annual Meeting; December 6-9, 2025; Orlando, FL. Abstract #100.
    2. 2.FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma. FDA. August 14, 2023. Accessed December 6, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-elranatamab-bcmm-multiple-myeloma
    3. 3.Lesokhin AM, Tomasson MH, Arnulf B, et al. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnestisMM-3 trial results. Nat Med. 2023;29(9):2259-2267. doi:10.1038/s41591-023-02528-9
    4. 4.Tomasson MH, Ida S, Niesvizky R, et al. Long-term survival and safety of elranatamab in patients with relapsed or refractory multiple myeloma: Update from the MagnetisMM-3 study. Hemasphere. 2024;8(7):e136. doi:10.1002/hem3.136

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  • Reimagining Old IT Equipment Before It Becomes Waste: How Business Can Turn Obsolete IT & Laptops into Opportunity

    Reimagining Old IT Equipment Before It Becomes Waste: How Business Can Turn Obsolete IT & Laptops into Opportunity

    Businesses can turn a looming wave of old tech into a powerful driver of impact and climate action by rethinking what happens to their Windows 10 devices. As support for the operating system ends, companies face a choice between scrapping millions of usable machines or putting them back to work for people and communities who are currently locked out of the digital world.

    Almost half of all Windows computers still run Windows 10, including millions used in UK businesses, leaving many devices at risk of becoming obsolete overnight as official support falls away and cyber risks rise. For IT and sustainability leaders, this is more than a technical upgrade issue. The way these assets are handled will shape corporate Scope 3 emissions performance and trust with stakeholders who are paying increasing attention to how businesses manage their social and environmental footprint.

    Within this context, the European Week for Waste Reduction in November created a timely reminder for companies looking to demonstrate that they take a genuinely circular approach.

    SocialBox.Biz, a UK based community interest company, is a leading initiative putting this approach into practice. It works with businesses to collect surplus laptops and IT equipment, install open-source software and redistribute the devices through national charity partners. This relatively simple switch in thinking reframes redundant laptops from before becoming waste liabilities into tools that help people learn, find work and stay connected. For example, rather than defaulting to recycling or IT disposal in the City of Westminster in London and beyond, Socialbox.biz is leading a growing movement to prioritise local reuse, keeping equipment in circulation for longer and maximising its social value.

    The personal story of SocialBox.Biz founder Peter Paduh, who arrived in the UK as a Bosnian child refugee, underscores why this matters. Receiving an old computer was a turning point that enabled him to study, apply for jobs and integrate into British society. That lived experience now underpins a model that allows today’s businesses to open similar doors for others with equipment they no longer need.

    From “old kit” to lifeline
    Partner organisations include Age UK branches, the Passage and the C4WS Homeless Project, who use repurposed devices to support people experiencing homelessness, older adults and others at risk of social exclusion. One beneficiary, Elaine, received a donated laptop while rebuilding her life after homelessness and was then able to enrol in college and continue her studies. Stories like this bring to life the human impact hidden inside corporate IT cupboards.

    Access to a working computer and the internet is now a basic requirement for participation in modern life, from applying for jobs and housing to accessing healthcare and public services. When businesses treat devices as disposable, those already facing disadvantage are often hit hardest by the resulting digital divide. Local reuse models help close this gap in ways that respond to specific community needs and build resilience.

    SocialBox.Biz highlights a particular demand for Chromebooks and larger screen MacBooks that can better serve older recipients and people with visual impairments. This emphasis on matching devices to users reinforces an important principle for any just and inclusive transition. Solutions must be designed with, not simply for, the people they aim to support.

    Climate gains companies can count
    Recycling will always play a role in responsible end of life management, but for many IT assets disposal it is far from the most sustainable first option. In the UK, the absence of dedicated IT smelters means that devices are often transported over long distances for energy intensive processing. By contrast, local reuse keeps value in the community, cuts transport emissions and makes better use of the embedded carbon already spent on manufacturing.

    “Call Before You Scrap It” Campaign
    SocialBox.Biz’s “Call Before You Scrap It” campaign captures this logic with a simple behavioural nudge to facilities, IT and procurement teams. Before equipment is consigned to recycling, staff are encouraged to ask whether it could instead be safely wiped, refurbished and passed on. In practice, this one extra step can shift a company’s relationship with its hardware from linear to circular.

    For companies seeking to strengthen their corporate impact story, structured reuse programmes create benefits across environmental, social and governance pillars. Environmentally, they cut emissions and waste. Socially, they drive digital inclusion for groups such as refugees, people experiencing homelessness and older adults, offering a lifeline at moments of acute vulnerability. From a governance perspective, partnering with specialist organisations can help ensure data security, regulatory compliance and transparent reporting.

    Build a culture that sees social impact as part of everyday business
    SocialBox.Biz supports corporate partners with tailored impact plans, communications materials and case studies, which can feed into annual reports and stakeholder engagement. Beyond formal reporting, involving employees in identifying surplus devices, supporting donation drives or mentoring beneficiaries can build a culture that sees social impact as part of everyday business, not a peripheral add on.

    The question is whether companies use this moment and the end of support for Windows 10 devices to reinforce a throwaway culture or to build new forms of partnership that keep technology, opportunity and carbon value in circulation for longer.

    For more information and to participate (even companies without access to items at this time can still participate in the Socialbox.biz impact plans.

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  • AI needs power desperately. Here’s how to -2-

    AI needs power desperately. Here’s how to -2-

    The bull case: Aggregation networks will use the arbitrage window to build defensible positions, then graduate from tactical plays to structural alternatives.

    The bear case? Networks are temporary stop-gaps that will get crushed the moment the next wave of data centers begin operating.

    The honest assessment? These networks will gorge themselves during the feast years, then adapt to leaner times, remaining profitable, just not explosive.

    For investors, that means treating this as what it is: a defined-window arbitrage play with asymmetric upside if the shortage persists longer than expected, and manageable downside if you size positions appropriately and respect the exit timeline.

    The AI infrastructure buildout is real. The computing shortage is real. The 2027-’29 constraint window is real. The question is whether you’re positioned to profit from the temporary dislocation before the market normalizes.

    Read: AI has real problems. The smart money is investing in the companies solving them now.

    More: The AI boom is over – here’s your bubble survival guide

    -Jurica Dujmovic

    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. 

    
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  • AI needs power desperately. Here’s how to invest in companies profiting from the pain.

    AI needs power desperately. Here’s how to invest in companies profiting from the pain.

    By Jurica Dujmovic

    The shortage is a lucrative opportunity – but the window is brief

    AI computing workloads could consume around 500 terawatt-hours annually by 2027 – about twice the U.K.’s total electricity consumption in 2023.

    Rising infrastructure costs and mounting capital constraints are deflating the AI boom. The hyperscalers can’t solve their computing problems fast enough, and that’s creating a rare arbitrage opportunity.

    The solution right now isn’t building data centers. The current investment opportunity lies in the temporary gap between exploding AI demand and the physical constraints of centralized infrastructure expansion. A handful of companies are exploiting this window – which likely will be a 24-to-36- month opportunity. For investors who understand the timing, it’s a compelling hedge against the AI infrastructure bottleneck.

    Physical barriers

    40% of AI data centers will face power constraints by 2027.

    AI’s limiting factor is no longer algorithms or data – it’s the brute-force physics of data-center expansion. Training large models demands tens of thousands of GPUs, dedicated networking and enormous power consumption. Gartner forecasts that 40% of AI data centers will face power constraints by 2027.

    The math is brutally simple: AI computing workloads could consume around 500 terawatt-hours annually by 2027 – about twice the U.K.’s total electricity consumption in 2023. This demand spike is already showing up in the grid.

    Dominion Energy (D), the biggest utility company in Virginia, nearly doubled its data-center power capacity under contract between July and December 2024, and the trend has persisted.

    Even with Microsoft (MSFT), Alphabet (GOOG) (GOOGL), Amazon.com (AMZN) and Meta Platforms (META) spending a combined $370 billion on capex in 2025, they can’t build fast enough. Construction and commissioning typically take 12 to 36 months, but when you include permitting and power-grid build-outs, a full data-center project can stretch to three to six years.

    Time and money

    The economics are compelling during this shortage window

    This time gap is the entire investment thesis.

    When essential resources become expensive and concentrated, parallel markets emerge. We saw this with electricity co-ops in the early 20th century, independent oil producers during OPEC’s reign and broadband resellers in the early internet era.

    With AI, the scarce resource is GPU computing. Several companies are building marketplaces that aggregate idle capacity – consumer GPUs, academic clusters, enterprise overstock – and resell it at a fraction of centralized data-center costs.

    The economics for these companies are compelling during this shortage window:

    Cost structure advantage: Alternative networks don’t finance data centers with debt. They pay participants directly for computing capacity through incentive structures, converting spare capacity into productive assets. The cost of scaling shifts from massive capex to distributed incentives.

    Speed to market: While hyperscalers wait 18 to 36 months for new facilities, these networks can add capacity node by node, with no billion-dollar commitments up front.

    Arbitrage pricing: These companies are capturing demand from the smaller labs, indie studios, emerging markets and others that are priced out of AWS GPU pricing but still need computing.

    The catch? The explosive growth window is finite. These networks will remain viable alternatives even after constraints ease – serving cost-sensitive workloads, emerging markets and indie developers – but the opportunity for substantial investment gains compresses as growth normalizes and hyperscalers’ capacity comes online.

    Read: AI data centers need juice. The next hot stocks give it.

    How to play the computing shortage

    Again, this isn’t a moonshot bet. It’s an infrastructure hedge with a defined window. Here are three approaches, ranked by risk profile:

    Render Network: Aggregates idle GPU capacity from individuals and studios, reselling to the highest bidder for rendering and AI workloads. Think of it as Airbnb for GPUs – idle capacity that would otherwise sit dormant gets monetized, and users get computing at a fraction of data-center pricing. Rather than operating expensive data centers, Render pays a fraction of that cost to harvest capacity from thousands of computers.

    io.net: Focuses on generic GPU computing for AI training and inference. The platform aggregates capacity from data centers, crypto miners and consumer hardware, creating a distributed alternative to centralized cloud providers. Its network is newer and more speculative than Render, but it’s capturing demand from AI startups that can’t afford or access hyperscaler GPU allocations.

    Akash Network: Takes the concept broader, offering a marketplace for general cloud computing and storage beyond just GPUs. This positions it as infrastructure for the full stack, not just AI-specific workloads. Akash is a privately held company but it does have a tradeable crypto token, AKT. This is the highest-risk play in this category, but offers the most diversified exposure if decentralized computing extends beyond AI.

    These are crypto token plays – not stocks

    Before going further, understand what you’re actually buying. All three of these networks operate through native cryptocurrency tokens, not traditional equity. There is no stock ticker, no brokerage-account access and no public-equity wrapper for these businesses.

    Direct exposure requires navigating cryptocurrency exchanges:

    — Render Network (RENDER) trades on Coinbase, Binance and Kraken.

    — is listed on select crypto exchanges such as Binance and Gate.io, with liquidity varying by venue and region.

    — Akash Network (AKT) trades on Coinbase, Kraken and similar venues.

    This means dealing with crypto custody – whether through exchange accounts or self-custody wallets – and accepting the regulatory uncertainty that comes with token investments. If you’re not comfortable with that infrastructure, this thesis won’t work for you.

    For investors who prefer traditional equity exposure, the closest alternatives are second-order beneficiaries of the same capacity constraint:

    — Data-center operators: Equinix EQIX, Digital Realty Trust DLR

    — Power infrastructure: Dominion Energy, Duke Energy DUK, NextEra Energy NEE

    — GPU supply chain: Nvidia NVDA, Broadcom AVGO, Super Micro Computer SMCI

    But here’s the critical distinction: These publicly traded companies benefit from the shortage itself – not from the temporary arbitrage window created by aggregating idle distributed capacity. They’ll do well regardless of whether decentralized computing succeeds. What they won’t give you is direct exposure to the specific dislocation that is going on now.

    Risk factors

    Let’s be clear about what could go wrong with this arbitrage strategy:

    Performance and reliability: Distributed GPU networks face inherent challenges with performance variance, latency and quality control. Enterprise customers paying for AI infrastructure demand reliability. If these networks can’t match centralized performance, the arbitrage doesn’t matter – customers won’t switch.

    Security and compliance: Regulated industries won’t run sensitive workloads on unknown hardware scattered globally. These networks are limited to specific use cases where data sovereignty and compliance aren’t blockers.

    Hyperscaler catch-up timeline: The base case assumes these constraints ease through 2027-’29 as new data centers and power infrastructure come online. If power constraints extend beyond 2029, the high-growth window for these companies stays open.

    Regulatory uncertainty: Several of these networks operate in regulatory gray areas. If governments decide to regulate decentralized computing infrastructure, costs increase and flexibility decreases.

    Crypto market contagion: These tokens trade on crypto exchanges and correlate with broader crypto markets. A bitcoin crash or crypto regulatory crackdown could affect these assets regardless of fundamentals.

    The investment timeline

    The window runs from early 2026 through 2027-’28, which is the core 24-to-36-month period. The broader infrastructure constraint lasts longer, but the outsized arbitrage compresses as hyperscalers come online. This aligns with the infrastructure constraint timeline I’ve been tracking, but extends beyond the initial shortage as power-grid limitations persist.

    Q1 2026: Begin building positions as the 2027 power constraint window becomes consensus view. Dollar-cost average to smooth volatility.

    Q2 2026-Q2 2027: Peak growth opportunity as AI demand continues accelerating while centralized capacity remains severely constrained. These networks capture maximum long-tail demand priced out of hyperscaler infrastructure.

    Q3 2027-Q2 2028: Growth continues, but begins normalizing as new data centers come online and power-grid upgrades progress. Monitor hyperscaler capacity announcements closely – each major facility completion incrementally compresses the arbitrage.

    Q3 2028-Q4 2029: Maturation phase. These networks settle into specialized roles – emerging markets, cost-sensitive workloads, indie developers. They remain viable businesses but growth normalizes.

    It is important to understand that this isn’t a binary “it works until it doesn’t” thesis. It’s a maturation curve where networks transition from high-growth arbitrage plays to steady-state infrastructure alternatives.

    The broader implication

    If GPU aggregation networks prove they can deliver reliable computing at competitive prices during the 2026-’28 constraint period, they will establish legitimacy. Even if hyperscalers eventually recapture market share, these networks will have carved out niches in emerging markets, indie studios and cost-sensitive workloads.

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  • Assessing Aker BP (OB:AKRBP)’s Valuation After Its Strong One-Year Shareholder Return

    Assessing Aker BP (OB:AKRBP)’s Valuation After Its Strong One-Year Shareholder Return

    Aker BP (OB:AKRBP) has quietly outperformed the broader market over the past year, and with the share price hovering around NOK 253, investors are asking whether the current level still offers value.

    See our latest analysis for Aker BP.

    That recent 2.76% 7 day share price return, alongside an 8.67% year to date share price gain, sits on top of a robust 28.34% one year total shareholder return. This suggests momentum is still broadly building despite short term swings.

    If Aker BP’s run has you rethinking your energy exposure, this could also be a good moment to scan other resilient players across aerospace and defense stocks for fresh ideas.

    With solid earnings growth and the shares trading only slightly below analyst targets, the key question now is whether Aker BP is still undervalued on fundamentals or if the market is already pricing in future growth.

    Aker BP’s latest close of NOK 253.10 sits modestly below the narrative’s NOK 262 fair value, framing a small but notable upside grounded in execution.

    Aker BP aims to sustain production above 500,000 barrels per day beyond 2030, driven by their 2 billion barrel opportunity and projects like Yggdrasil and Johan Sverdrup. This supports long-term revenue growth through extended production capacities.

    Read the complete narrative.

    Curious how modest top line growth, rising margins and a reset earnings multiple still add up to upside from here? The narrative hides a surprisingly bold earnings trajectory, powered by disciplined volumes and a valuation reset that leans on future profitability rather than heroic growth. Want to see how those moving parts combine into that fair value call?

    Result: Fair Value of $262 (UNDERVALUED)

    Have a read of the narrative in full and understand what’s behind the forecasts.

    However, structural risks, such as rising emissions costs and heavy reliance on key fields, could undermine margins and challenge the current fair value case.

    Find out about the key risks to this Aker BP narrative.

    On earnings, Aker BP looks far less forgiving, trading on an 18.8x price to earnings ratio versus a fair ratio of 11.2x; 11.7x for the wider European oil and gas group; and 9.2x for peers. That premium narrows the margin of safety, so how long can sentiment stay this strong?

    See what the numbers say about this price — find out in our valuation breakdown.

    OB:AKRBP PE Ratio as at Dec 2025

    If you would rather challenge these views or dig into the numbers yourself, you can build a personalised take in just minutes: Do it your way.

    A great starting point for your Aker BP research is our analysis highlighting 2 key rewards and 3 important warning signs that could impact your investment decision.

    Do not stop at a single stock when Simply Wall Street’s Screener can quickly surface fresh, data backed opportunities that others overlook and you can act on first.

    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

    Companies discussed in this article include AKRBP.OL.

    Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

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  • Argan (AGX) Valuation Check After a Sharp Pullback in the Share Price

    Argan (AGX) Valuation Check After a Sharp Pullback in the Share Price

    Argan (AGX) has pulled back sharply this week, slipping about 12% in a single session and over 20% in the past week, even though the shares remain significantly higher over the past three months.

    See our latest analysis for Argan.

    Even after this week’s slide, Argan’s 1 year total shareholder return of around 115% and enormous 3 year total shareholder return appear to signal strong underlying momentum. At the same time, the recent pullback suggests investors are reassessing short term risk after a powerful run.

    If Argan’s surge has you rethinking your watchlist, it could be a smart moment to explore fast growing stocks with high insider ownership to research other fast moving opportunities with strong insider conviction.

    With Argan still trading below analyst targets and implying a hefty intrinsic discount, investors now face a pivotal question: Is the stock still undervalued, or is the market already pricing in years of future growth?

    With Argan closing around $313.70 versus a narrative fair value of roughly $295.75, the most followed view sees recent strength pushing into premium territory.

    Record backlog and continued project wins across gas, renewables, water treatment, and recycling plants provide multi-year revenue visibility, indicating potential for increased operating leverage and higher gross margins as larger projects are executed successfully.

    Read the complete narrative.

    Curious how multi year double digit expansion, moderating margins, and a richer future earnings multiple still add up to upside in this framework? The growth math behind that conclusion is not what most investors would expect from a construction contractor. Want to see which long term revenue and profit assumptions quietly justify paying up from here? Explore the full narrative to unpack the projections that support this valuation view.

    Result: Fair Value of $295.75 (OVERVALUED)

    Have a read of the narrative in full and understand what’s behind the forecasts.

    However, the thesis leans heavily on large gas projects, so any delays, cancellations, or faster than expected decarbonization could quickly pressure earnings.

    Find out about the key risks to this Argan narrative.

    Our SWS DCF model suggests Argan is trading about 42.7% below its fair value of $547.36, a sharp contrast to the narrative view that sees the stock as slightly overvalued. If cash flows point one way and sentiment another, which signal do you trust?

    Look into how the SWS DCF model arrives at its fair value.

    AGX Discounted Cash Flow as at Dec 2025

    Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out Argan for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover 906 undervalued stocks based on their cash flows. If you save a screener we even alert you when new companies match – so you never miss a potential opportunity.

    If you see the story differently or want to dig into the numbers yourself, you can build a custom view in minutes: Do it your way.

    A great starting point for your Argan research is our analysis highlighting 3 key rewards and 1 important warning sign that could impact your investment decision.

    Before the market’s next move leaves you catching up, put Simply Wall Street’s Screener to work and uncover focused opportunities that match your exact investing style.

    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

    Companies discussed in this article include AGX.

    Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

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