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  • Fixed-Duration Epcoritamab Plus Chemotherapy Yields Response, Remissions in DLBCL

    Fixed-Duration Epcoritamab Plus Chemotherapy Yields Response, Remissions in DLBCL

    At the American Society of Hematology (ASH) 2025 meeting, updated results from the phase 2 EPCORE NHL‑2 (NCT04663347) trial highlighted the potential of epcoritamab combined with chemotherapy to improve outcomes for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL), spanning both high-risk and frail or older populations.

    The EPCORE NHL‑2 trial phase 1b/2 enrolled adults with newly diagnosed CD20-positive DLBCL who were ineligible for full-dose R‑CHOP due to age (75 years and older) or age 65 years and older with significant comorbidities.1 Patients received a fixed-duration regimen of subcutaneous epcoritamab 48 mg combined with R‑mini‑CHOP. Epcoritamab was administered weekly in cycles 1–2, every 3 weeks in cycles 3–6, and every 4 weeks in cycles 7–8, with step-up dosing during the cycle. The primary end point was overall response rate (ORR). Secondary end points included minimal residual disease (MRD) negativity, assessed using the AVENIO Oncology circulating tumor DNA (ctDNA) assay, with MRD negativity defined as less than 1 mutant molecule/mL. Safety, treatment completion, and relative dose intensity of R‑mini‑CHOP were also evaluated.

    As of April 9, 2025, 28 patients received epcoritamab plus R-mini-CHOP. Median (IQR) age was 81 (74, 90) years. Most patients (79%) completed treatment, with a median R-mini-CHOP dose intensity of 94% or greater. ORR was 89% and the CR rate was 86%, while the median duration of response and complete response (CR) were not reached. Estimated 2-year progression-free survival (PFS) and overall survival (OS) were 76% and 82%, respectively. MRD negativity was achieved in 95% of evaluable patients, including 93% with International Prognostic Index (IPI) 3 through 5 and 89% with bulky disease; 86% of patients MRD-negative at C3D1 sustained negativity through C6D1. Grade 3 or greater infections occurred in 29% of patients, and 11% discontinued epcoritamab due to treatment-emergent adverse events.

    In the second analysis, patients received fixed-duration epcoritamab in combination with 6 cycles of standard R‑CHOP, followed by epcoritamab monotherapy for up to 1 year.2 Epcoritamab was administered subcutaneously with step-up dosing during cycle 1 and weekly in cycles 1–4, then every 3 weeks in cycles 5–6, with subsequent monthly monotherapy. The study evaluated efficacy using investigator-assessed ORR as the primary end point. Secondary end points included CR rate, duration of response, PFS and OS, safety, and tolerability. MRD negativity was also assessed.

    A total of 47 patients received epcoritamab plus R‑CHOP. Median age was 64 (19, 82) years. IPI scores were 3 in 57% of patients and 4–5 in 38%. After a median follow-up of 38.8 (0.8, 44.3) months, ORR was 98% and CR rate was 85%, with 67% of responses and 75% of CRs ongoing at 33 months.

    High CR rates were observed across subgroups (IPI 3, 86% vs IPI 4-5, 83%), age, tumor size, and cell of origin. By cycle 3 day 1, 86% of MRD-evaluable patients were MRD negative, with sustained reductions in ctDNA through cycle 6 day 1. Most patients (94%) completed 6 cycles of R‑CHOP, and 68% completed treatment as planned; among these, 30 of 32 patients had a CR, with 87% maintaining response at a median 25.3-month follow-up. Safety was consistent with prior reports, with serious or grade 3 or greater infections primarily in the first 6 months and no new grade 5 events reported.

    References

    1. Cheah C, Belada D, Darrah J, et al. Epcoritamab plus R-mini-CHOP results in 2-year remissions and high MRD negativity rates in elderly patients with newly diagnosed DLBCL: Results from the EPCORE NHL-2 trial. Presented at: ASH 2025; December 6-9, 2025; Orlando, Florida. Poster 64

    2. Falchi L, de Vos S, Brody J, et al. Fixed-duration epcoritamab plus R-CHOP in patients with newly diagnosed DLBCL and high IPI scores (3–5) led to sustained remissions and disease-free survival beyond 3 years: Results from the EPCORE NHL-2 trial. Presented at: ASH 2025; December 6-9, 2025; Orlando, Florida. Poster 1955

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  • Epcoritamab Combo Significantly Improves Efficacy in 2L R/R Follicular Lymphoma

    Epcoritamab Combo Significantly Improves Efficacy in 2L R/R Follicular Lymphoma

    Fixed-duration epcoritamab (Epkinly) plus rituximab (Rituxan) and lenalidomide (Revlimid; R2) demonstrated significant improvements in progression-free survival (PFS) and response rates compared with R2 alone in patients with relapsed/refractory follicular lymphoma, according to findings from the phase 3 EPCORE FL-1 trial (NCT05409066) presented in a press briefing during the 2025 American Society of Hematology (ASH) Annual Meeting and Exposition.1,2

    At a median follow-up of 14.8 months, results showed that the median PFS per independent review committee (IRC) was not estimable with epcoritamab (95% CI, NE-NE) plus R2 compared with 11.7 months (95% CI, 11.1-15.1) with R2 alone, leading to a 79% reduction in the risk of disease progression or death (HR, 0.21; 95% CI, 0.14-0.31; P <.0001). The concordance rate was 94% for PFS between IRC and investigator assessment. The estimated 16-month PFS rates were 85.5% (95% CI, 79.7%-89.7%) and 40.2% (95% CI, 31.8%-48.4%), respectively.

    The epcoritamab regimen elicited a 95% objective response rate (ORR) compared with 79% with R2 alone (P <.0001). In the epcoritamab arm, the complete response (CR) rate was 83% and the partial response (PR) rate was 12%; 1 patient had stable disease (SD), 3% of patients had progressive disease (PD), and 2% were not evaluable. In the R2 arm, the CR rate was 50% and the PR rate was 29%; 7% of patients each had SD, PD, and were not evaluable.

    “Epcoritamab and R2 is a novel chemotherapy-free, fixed-duration therapy that is suitable for outpatient administration, and we believe sets a new benchmark as standard of care for second-line [and beyond] follicular lymphoma,” lead study author Lorenzo Falchi, MD, of the Lymphoma Service at Memorial Sloan Kettering Cancer Center in New York, NY, said in the oral presentation. “We’re happy to see that the FDA granted full approval to epcoritamab and R2 on November 18, 2025, for [this patient population].”

    R2 is the only second-line alternative to chemoimmunotherapy-based treatment for patients with relapsed/refractory follicular lymphoma. The FDA initially approved epcoritamab, a CD3xCD20 bispecific antibody, as a single agent for the treatment of patients with relapsed/refractory follicular lymphoma following at least 2 lines of systemic therapy.3

    Early data from the phase 1b/2 EPCORE NHL-2 trial (NCT04663347), which evaluated fixed-duration epcoritamab plus R2 for relapsed/refractory follicular lymphoma, demonstrated deep and durable responses and a manageable safety profile.4

    In November 2025, the FDA also approved epcoritamab in combination with R2 in relapsed/refractory follicular lymphoma, based on the phase 3 EPCORE FL-1 findings, which is what Falchi presented during the press briefing.5 In the international, open-label, EPCORE FL-1 trial, patients underwent a 1:1 randomization to receive fixed-duration epcoritamab at 48 mg plus R2 (n = 243) or R2 alone (n = 245).

    Epcoritamab was administered in a 3-step-up, 2-dosing schedule at 0.16 mg on day 1, 0.8 mg on day 8, and 3 mg on day 15, all in cycle 1. Cycles 2 and 3 were administered weekly, and cycles 4 to 12 were administered every 4 weeks. Rituximab was given at 375 mg/m2 for 5 cycles; the agent was given weekly in cycle 1 and every 4 weeks in cycles 2 through 5. Lastly, lenalidomide was given at 20 mg for 12 cycles; treatment was given daily in cycles 1 through 12 on days 1 through 21.

    The dual primary end points were ORR and PFS, both per IRC; key secondary end points were CR rate per IRC, overall survival (OS), and minimal residual disease. Additional secondary end points were duration of response (DOR), duration of complete response, time to next lymphoma treatment (TTNLT), safety, and patient-reported outcome assessments.

    The data cutoff date was May 24, 2025, and patients were enrolled between October 2022 and January 2025.

    To be eligible for enrollment, patients had to have histologically confirmed CD20-positive follicular lymphoma that was grade 1 to 3a and stage II to IV. At least 1 prior treatment was required, including an anti-CD20 monoclonal antibody plus an alkylating agent, and at least 1 Groupe d’Etude des Lymphomes Folliculaires criterion needed to be met.

    Patients were stratified by disease status in second line (> or ≤ 2 years since last therapy), third line (> or <6 months since last therapy), and region (US/EU vs rest of world).

    Baseline characteristics showed that the median age was 61 years (range, 24-89), and 40% of patients were at least 65 years old; 57% of patients were male, and 72% were White. Thirty-one percent of patients had an ECOG performance status of 1 to 2, while 83% had Ann Arbor stage III to IV disease. Regarding Follicular Lymphoma International Prognostic Index, the breakdown of scores was 0 to 1 (24%), 2 (32%), and 3 to 5 (44%). Twenty-two percent of patients had bulky disease, consisting of at least 7 cm.

    The median time from initial diagnosis to randomization was 5 years (range, 0.1-43.0), and the median number of prior lines of therapy was 1 (range, 1-7), with most patients receiving 1 (59%), 2 (24%), or at least 3 (17%). All patients received a prior anti-CD20 antibody, and 3% had received prior R2. Forty-one percent of patients experienced disease progression within 2 years from starting frontline therapy; 34% of patients were refractory to their first-line therapy, and 37% of patients had double-refractory disease.

    Additional efficacy data showed that the median DOR with epcoritamab plus R2 was NE (95% CI, NE-NE) compared with 11.5 months (95% CI, 8.5-18.6) with R2 alone (HR, 0.19; 95% CI, 0.12-0.30; P <.0001).

    The epcoritamab regimen also extended TTNLT; the median was NE (NE-NE) compared with 24.3 months (95% CI, 18.2-NE) with R2 alone (HR, 0.15; 95% CI, 0.09-0.27; P <.0001). At 16 months, 92.8% of patients on epcoritamab plus R2 remained free from new anti-lymphoma therapy vs 64.9% of those on R2 alone.

    Falchi noted there is a positive trend for OS with the epcoritamab arm, which is NE (95% CI, NE-NE) in both arms (HR, 0.38; 95% CI, 0.18-0.80; P = .0039), adding that there are 10 and 25 events in the epcoritamab and R2-alone arms, respectively. Sixteen-month estimates for OS were 95.8% for epcoritamab plus R2 vs 88.8% with R2 alone.

    Regarding safety, any-grade adverse events occurred in 100% and 99% of patients on epcoritamab plus R2 and R2 alone, with grade 3 or higher AEs at 90% and 68%, respectively. Serious AEs occurred in 56% and 29%, respectively, and AEs that led to treatment discontinuation occurred in 19% and 12% of patients.

    Any-grade and grade 3 or higher AEs of clinical interest occurring in at least 20% of patients on epcoritamab/R2 and R2 alone included infections (77% and 33% vs 53% and 16%), neutropenia (74% and 69% vs 52% and 42%), cytokine release syndrome (any-grade, 35% vs <1%) thrombocytopenia (28% and 9% vs 18% and 6%), pyrexia (24% and <1%; 14% and 1%), rash (24% and 8% vs 22% and 4%), and COVID-19 (22% and 3% vs 13% and 2%).

    On the epcoritamab arm, 3% of patients discontinued due to neutropenia vs 2% in the R2-alone arm. Febrile neutropenia occurred in 6% and 3% of patients, respectively. Discontinuation rates due to infections occurred in 6% and 1% of patients, respectively.

    Two percent and 4% of patients on epcoritamab and R2 and R2 alone experienced fatal AEs.

    “Despite these higher rates of AEs in the epcoritamab and R2 arm, the median relative dose intensity was greater than 90%,” Falchi added.

    Disclosures: Falchi cited consultancy, including expert testimony, with Johnson & Johnson, Roche, ADC Therapeutics, Evommune, F. Hoffman-La Roche Ltd., AbbVie, Sanofi, Genentech, AstraZeneca, Seagen, Merck, and Genmab; honoraria from Roche, Kite Pharma, F. Hoffman-La Roche Ltd., AbbVie, and Genmab; and research funding from Roche, F. Hoffman-La Roche Ltd., AbbVie, Innate Pharma, Genentech, BeiGene, AstraZeneca, and Genmab.

    References

    1. Falchi L, Nijland M, Huang H, et al. Primary phase 3 results from the EPCORE- FL-1 trial of epcoritamab with rituximab and lenalidomide (R2) versus R2 for relapsed or refractory follicular lymphoma. Blood. 2025;146(supplement 1):466. doi:10.1182/blood-2025-466
    2. Falchi L, Nijiland M, Huang H, et al. Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed/refractory follicular lymphoma (EPCORE FL-1): a global, open-label, randomised, phase 3 trial. Lancet. Published online December 7, 2025. doi:10.1016/50140-6736(25)02360-8
    3. EPKINLY™ (epcoritamab-bysp) injection prescribing information. FDA. Updated May 2023. Accessed December 7, 2025. https://tinyurl.com/mrvfmaur
    4. Falchi L, Sureda A, Leppä S, et al. Fixed-duration epcoritamab plus R2 drives favorable outcomes in relapsed or refractory follicular lymphoma. Blood. 2025;146(22):2629-2640. doi:10.1182/blood.2025029909
    5. FDA approves epcoritamab-bysp for follicular lymphoma indications. News release. FDA. November 18, 2025. Accessed December 7, 2025. https://tinyurl.com/y8t4hh3a

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  • Grotmas Calendar Day 7 – Embrace the tragic madness of the Blood Angels with a new Detachment

    Grotmas Calendar Day 7 – Embrace the tragic madness of the Blood Angels with a new Detachment

    The Red Thirst and the Black Rage will forever be the twin spiritual curses that the Blood Angels must hide from their allies for fear of censure. However, they can prove potent weapons of last resort when unleashed upon a determined foe. No Blood Angel takes such a decision lightly: to the sons of Sanguinius, a victory won through giving in to their Red Thirst is tainted at best, whilst to succumb to the Black Rage is no better than a living death. All this is little comfort to enemies facing the Blood Angels’ onslaught in such moments, however. Power-armoured killers pound across the battlefield, shrugging off incoming fire as they close the distance with terrifying haste. Blood detonates from each crunching charge as the sons of Sanguinius rip their victims apart or carve them into gory ruin. At the very heart of the battle, the lost brethren of the Death Company fight with even greater fury, a whirlwind of rage-fuelled savagery that can end only with their deaths or those of all their foes.

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  • Brookfield, GIC near binding offer for National Storage, Bloomberg News reports

    Brookfield, GIC near binding offer for National Storage, Bloomberg News reports

    Dec 7 (Reuters) – Brookfield Asset Management (BAM.N), opens new tab and Singapore’s GIC are nearing a binding offer for National Storage REIT (NSR.AX), opens new tab in a deal that may value the Sydney-listed company at about 4 billion Australian dollars ($2.65 billion), Bloomberg News reported on Sunday, citing people familiar with the matter.

    The parties are finalizing details of the deal that could be announced as soon as Monday, the report said, adding that, Brookfield and GIC have successfully made progress on due diligence on National Storage.

    Sign up here.

    According to the report, the price of the binding offer is likely to be the same as a conditional one in November.

    Reuters could not immediately verify the report.

    Last month, National Storage REIT (NSR.AX), opens new tab said it had received a A$4.02 billion buyout offer from a consortium of Brookfield and Singapore’s GIC in what would be the country’s biggest real estate privatisation deal.

    ($1 = 1.5067 Australian dollars)

    Reporting by Abu Sultan in Bengaluru; Editing by Andrea Ricci

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

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  • Pakistan’s crypto deal with Binance & why Asim Munir, even ISI are ‘in the picture’

    Pakistan’s crypto deal with Binance & why Asim Munir, even ISI are ‘in the picture’

    New Delhi: Pakistan is going all out on crypto, and it’s not merely an economic step but also a deeply political one in which the country’s military and intelligence seem involved too.

    A day after he was elevated as the country’s most powerful commander yet, Army Chief and Chief of Defence Forces Field Marshal Asim Munir joined Prime Minister Shehbaz Sharif and Inter-Services Intelligence (ISI) chief Asim Malik in a high-profile meeting in Islamabad with crypto firm Binance’s CEO Richard Teng.

    Also seen with them was Bilal Bin Saqib, chairman of the newly formed Pakistan Virtual Assets Regulatory Authority (PVARA), who briefed them on Pakistan’s National Digital Assets Framework.

    Pakistan’s Ministry of Finance later said that the meeting, which also had senior Binance executives in attendance, focused on building a “secure, transparent and innovation-driven digital asset ecosystem” in the country.

    The meeting and the finance ministry’s assertion came even as local banks have been raising the alarm against the crypto push in Pakistan.

    According to a Dawn report, at a consultative meeting convened Friday by the finance ministry and PVARA, Pakistan’s top banks expressed concern about money laundering, compliance risks, and global precedents where crypto-related gaps triggered major regulatory penalties.

    Yet, the government appears determined to move forward.

    According to the report, the government has now floated a “time-bound amnesty” allowing crypto traders, who handle more than $250 billion in annual turnover, to shift assets onto regulated platforms with no penalty.

    A Binance representative told participants that Pakistani users hold around $5 billion on Binance alone, and argued that tokenised assets should be counted as part of Pakistan’s “liquid money supply”, according to the Dawn report.

    “Liquid money supply” includes assets that can be easily and immediately used as a medium of exchange for transactions.

    The Dawn reported that they were told, according to those present at the meeting, that Binance could provide real-time reporting, enable banks to lend against digitally verified collateral, and help Pakistan attract billions of dollars in new inflows, including new remittance routes that could sit atop the $38-billion Pakistan receives annually from overseas workers.

    Banks, however, asked whether expecting such visibility and traceability was realistic.

    Also Read: Pakistan’s $21 billion crypto market is out of the shadows. It’s finally legal there

    Pakistan’s crypto rush

    Crypto is officially banned for financial institutions in Pakistan, but it is allowed as legal tender.

    In February, the Pakistani government established a Crypto Council. In May, the government shifted towards legalisation with proposals to regulate it as an economic lifeline through a formal, legal framework.

    Also, the Crypto Council was elevated to a full-fledged regulatory body named the Pakistan Digital Assets Authority, tasked with overseeing and regulating digital assets, including cryptocurrencies and blockchain technologies.

    Before that, in April, Pakistan entered into a partnership with World Liberty Financial (WLF), a firm reportedly connected to members of Trump’s family. WLF has pledged support in helping Pakistan develop blockchain infrastructure, tokenise assets, and navigate the broader crypto industry. However, the specifics of the agreement remain unclear.

    Then in July, the Virtual Assets Ordinance 2025 came into force for establishing a regulatory and sandbox environment through the creation of Pakistan Virtual Assets Regulatory Authority (PVARA), the national regulator for virtual assets in Pakistan which would be independent.

    The State Bank of Pakistan (SBP), the country’s central bank which had banned crypto, announced in September that it would withdraw its earlier advisory against cryptocurrencies and begin formal legalisation.

    It then announced it was drafting a central bank digital currency (CBDC) and coordinating with lawmakers on the Virtual Assets Act 2025, which will create a fully regulated framework for digital asset trading.

    But why did the government move to regulate and legalise crypto so hurriedly—all within a year?

    For Pakistan, crypto could offer a potential workaround to its known structural economic constraints—from slow banking systems to chronic foreign exchange shortages. Tokenised assets and remittance rails could ideally unlock new inflows.

    From the point of view of Binance, Pakistan has 40 million Binance users, making it one of its biggest untapped regulated markets. A State-backed embrace of crypto could cement Binance’s dominance at a moment when its US legal troubles threaten its global footprint.

    And, there could be a US angle, a Chinese and a military push to it too.

    Binance–Trump–Pakistan triangle

    Looming over Pakistan’s crypto pivot is the global controversy surrounding Binance and its Chinese founder Changpeng Zhao (CZ), who maintains a 90 percent stake in the company.

    Zhao, who pleaded guilty in 2023 to failing to implement the US anti-money-laundering law at Binance and served several months in jail, received a presidential pardon from Donald Trump last month—a move Trump later claimed he barely recalled.

    The pardon came shortly before Zhao deepened his engagement with Pakistan. In early 2025, Islamabad appointed him strategic adviser to the Pakistan Crypto Council, and several of Pakistan’s new crypto institutions, including the Pakistan Digital Assets Authority, were reportedly shaped with his input.

    The relationship also intersects with the Trump family’s own crypto portfolio. Their company, World Liberty Financial (WLF), launched the USD1 stablecoin using code reportedly written with Binance’s help. Binance then promoted USD1 to its vast global user base, helping accumulate more than $2 billion worth of deposits that generate multimillion-dollar yields for Trump-linked interests.

    Pakistan has since signed a “letter of intent” with WLF to cooperate on blockchain infrastructure and stablecoin integration. Bilal Bin Saqib, Pakistan’s key crypto architect, is also an adviser to WLF.

    (Edited by Ajeet Tiwari)

    Also Read: Crypto, crisis & the Trump connection: All about Pakistan’s new Virtual Assets Act

     


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  • Gintemetostat Shows Early Activity and Manageable Safety in Triple-Class Refractory Multiple Myeloma

    Gintemetostat Shows Early Activity and Manageable Safety in Triple-Class Refractory Multiple Myeloma

    Early data from the phase 1 trial (NCT05651932) of the MMSET/NSD2 inhibitor gintemetostat (KTX-1001) revealed that the agent was tolerable and produced encouraging antitumor activity in a heavily pretreated population of patients with relapsed or refractory multiple myeloma, including those with triple-class–refractory disease and high-risk features such as t(4;14). These results were presented at the 2025 ASH Annual Meeting, and Exposition.

    Among 40 patients treated with gintemetostat, 1 patient had a very good partial response, 1 patient had a partial response, 2 patients had a minimal response, and 12 patients had stable disease.

    “Single-agent activity was demonstrated in heavily pretreated R/R multiple myeloma including t(4;14) positive patients across different dose-escalation cohorts,” said lead author Saad Usmani, MD, MBA, chief of Myeloma Service at Memorial Sloan Kettering Cancer Center.

    Safety and Tolerability

    The safety profile from the phase 1 study showed that 75% of patients experienced treatment-emergent adverse events (TEAEs) potentially related to gintemetostat and 45% experienced grade 3 or higher potentially gintemetostat-related TEAEs. Three patients had TEAEs that required a dose reduction.

    Twelve patients remained on treatment at the data cutoff date of June 13, 2025. Of the 28 patients who discontinued treatment, progressive disease was the cause for 82%, physician decision for 7.1%, consent withdrawal for 7.1%, and TEAE for 3.6% (1 patient).

    The most common grade 3/4hematologic TEAEs were thrombocytopenia (grade 3, 10%; grade 4, 20%), anemia (25%; 0%), neutropenia (25%; 5%), and febrile neutropenia (5%; 0%). The most common grade 3 nonhematologic TEAEs were infections (12.5%) and fatigue (10%).

    There were 2 patient deaths, both of which were not related to gintemetostat treatment. One patient death was due to respiratory failure and the other was due to pleural effusion.

    Study Background, Design, and Patient Characteristics

    Regarding the rationale for the study, Usmani explained, “Overexpression of MMSET—also known as NSD2—often results from t(4;14) and is associated with poor clinical outcomes in patients with multiple myeloma.”

    Accordingly, Usmani et al sought to explore the safety and efficacy of gintemetostat, an oral, first-in-class, potent and selective inhibitor of MMSET4 in patients with R/R multiple myeloma.

    The ongoing, open-label, multicenter phase 1 dose escalation/expansion study of gintemetostat has accrued 40 patients with R/R multiple myeloma. The study is enrolling patients aged ≥18 years with R/R multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody.

    The median age of the 40 patients in the dose-escalation phase was 69 years (range, 50–83) and 52.5% of patients were female. The ECOG performance status was 0 (22.5%) and 1 (77.5%). The median time since initial diagnosis was 8 years (range, 2–20). About one-third (32.5%) of patients had extramedullary disease and 30% had high-risk multiple myeloma per IMWG criteria.

    Regarding cytogenetic abnormalities, 47.5% of patients had t(4;14), comprising 20% with t(4;14) with 1q+ or del(1p32), and 27.5% with t(4;14) alone. Further, 1 patient had t(14;20), 5 had 1q21 amplification, and 4 had del(17p).

    The median number of prior lines of therapy was 6.5 (range, 3–25), with 77.5% of patients having received at least 5 lines of therapy. Seventy percent of patients had prior stem cell transplant.

    Prior drug classes of therapy received included IMiD/PI (100%), anti-CD38 (98%), BCMA CAR-T (42.5%), BCMA-targeted bispecific antibodies (BsAb) and antibody-drug conjugates (57.5%), GPRC5D-targeted BsAb (32.5%), and FcRH5-targeted BsAb (7.5%). All patients except 1 were triple-drug exposed and 80% were penta-drug exposed.

    Overall, 9 dose levels have been assessed using a 3+3 dose-escalation design. Gintemetostat is being administered orally in a 28-day cycle. Usmani did not provide the specific details of the what the different dose levels were.

    Regarding pharmacokinetics, Usmani said, “Gintemetostat plasma concentrations increased with dose across all 9 dose levels tested, and at steady-state, moderate variability in exposure of gintemetostat was observed.”

    Summary and Next Steps

    In a news release accompanying the presentation at the ASH meeting, a statement from Usmani summarized the findings and next steps with gintemetostat.

    “In the dose-escalation phase, gintemetostat monotherapy showed a favorable safety and tolerability profile and demonstrated disease control and efficacy. Pharmacodynamic data confirm target engagement, and we look forward to advancing into the dose-expansion phase to evaluate combinations with proteasome inhibitors, IMiDs, and next-generation CELMoDs such as mezigdomide,” stated Usmani.2

    References

    1. Usmani S, Bories P, Gasparetto C, et al. Phase 1 study of ktx-1001, a first-in-class oral MMSET/NSD2 inhibitor, demonstrates clinical activity in relapsed/refractory multiple myeloma. Blood. 2025;146(suppl 1): 250. doi:10.1182/blood-2025-250

    2. K36 Therapeutics announces presentation of First-in-Human Clinical Data for Gintemetostat (KTX-1001) Demonstrating Target Engagement and Clinical Activity in Multiple Myeloma at ASH 2025 and the Appointment of Dr. Shinta Cheng, M.D., Ph.D., as Chief Medical Officer. Published online December 5, 2025. Accessed December 7, 2025. https://tinyurl.com/3wzem4nx

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  • Gintemetostat Has Single-Agent Activity in Pretreated R/R Multiple Myeloma

    Gintemetostat Has Single-Agent Activity in Pretreated R/R Multiple Myeloma

    Preliminary activity and favorable safety were observed among patients with heavily pretreated, triple-class refractory, relapsed/refractory multiple myeloma who received single-agent gintemetostat (KTX-1001), according to a presentation on findings from a phase 1 study (NCT05651932) at the 2025 American Society of Hematology (ASH) Annual Meeting and Exposition.1

    Among 40 patients treated with gintemetostat, 1 patient had a very good partial response, 1 patient had a partial response, 2 patients had a minimal response, and 12 patients had stable disease.

    “Single-agent activity was demonstrated in heavily pretreated R/R multiple myeloma including t(4;14) positive patients across different dose-escalation cohorts,” said lead author Saad Usmani, MD, MBA, chief of Myeloma Service at Memorial Sloan Kettering Cancer Center.

    Safety and Tolerability

    The safety profile from the phase 1 study showed that 75% of patients experienced treatment-emergent adverse events (TEAEs) potentially related to gintemetostat and 45% experienced grade ≥3 potentially gintemetostat-related TEAEs. Three patients had TEAEs that required a dose reduction.

    Twelve patients remained on treatment at the data cutoff date of June 13, 2025. Of the 28 patients who discontinued treatment, progressive disease was the cause for 82%, physician decision for 7.1%, consent withdrawal for 7.1%, and TEAE for 3.6% (1 patient)

    The most common grade 3/4hematologic TEAEs were thrombocytopenia (grade 3, 10%; grade 4, 20%), anemia (25%; 0%), neutropenia (25%; 5%), and febrile neutropenia (5%; 0%). The most common grade 3 nonhematologic TEAEs were infections (12.5%) and fatigue (10%).

    There were 2 patient deaths, both of which were not related to gintemetostat treatment. One patient death was due to respiratory failure and the other was due to pleural effusion.

    Study Background, Design, and Patient Characteristics

    Regarding the rationale for the study, Usmani explained, “Overexpression of MMSET—also known as NSD2—often results from t(4;14) and is associated with poor clinical outcomes in patients with multiple myeloma.”

    Accordingly, Usmani et al sought to explore the safety and efficacy of gintemetostat, an oral, first-in-class, potent and selective inhibitor of MMSET4 in patients with R/R multiple myeloma.

    The ongoing, open-label, multicenter phase 1 dose escalation/expansion study of gintemetostat has accrued 40 patients with R/R multiple myeloma. The study is enrolling patients aged ≥18 years with R/R multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody.

    The median age of the 40 patients in the dose-escalation phase was 69 years (range, 50-83) and 52.5% of patients were female. The ECOG performance status was 0 (22.5%) and 1 (77.5%). The median time since initial diagnosis was 8 years (range, 2-20). About one-third (32.5%) of patients had extramedullary disease and 30% had high-risk multiple myeloma per IMWG criteria.

    Regarding cytogenetic abnormalities, 47.5% of patients had t(4;14), comprising 20% with t(4;14) with 1q+ or del(1p32), and 27.5% with t(4;14) alone. Further, 1 patient had t(14;20), 5 had 1q21 amplification, and 4 had del(17p).

    The median number of prior lines of therapy was 6.5 (range, 3-25), with 77.5% of patients having received at least 5 lines of therapy. Seventy percent of patients had prior stem cell transplant.

    Prior drug classes of therapy received included IMiD/PI (100%), anti-CD38 (98%), BCMA CAR-T (42.5%), BCMA-targeted bispecific antibodies (BsAb) and antibody-drug conjugates (57.5%), GPRC5D-targeted BsAb (32.5%), and FcRH5-targeted BsAb (7.5%). All patients except 1 were triple-drug exposed and 80% were penta-drug exposed.

    Overall, 9 dose levels have been assessed using a 3+3 dose-escalation design. Gintemetostat is being administered orally in a 28-day cycle. Usmani did not provide the specific details of the what the different dose levels were.

    Regarding pharmacokinetics, Usmani said, “Gintemetostat plasma concentrations increased with dose across all 9 dose levels tested, and at steady-state, moderate variability in exposure of gintemetostat was observed.”

    Summary and Next Steps

    In a news release accompanying the presentation at the ASH meeting, a statement from Usmani summarized the findings and next steps with gintemetostat.

    “In the dose-escalation phase, gintemetostat monotherapy showed a favorable safety and tolerability profile and demonstrated disease control and efficacy. Pharmacodynamic data confirm target engagement, and we look forward to advancing into the dose-expansion phase to evaluate combinations with proteasome inhibitors, IMiDs, and next-generation CELMoDs such as mezigdomide,” stated Usmani.2

    References

    1. Usmani S, Bories P, Gasparetto C, et al. Phase 1 study of ktx-1001, a first-in-class oral MMSET/NSD2 inhibitor, demonstrates clinical activity in relapsed/refractory multiple myeloma. Blood. 2025;146(suppl 1): 250. doi:10.1182/blood-2025-250
    2. K36 Therapeutics announces presentation of First-in-Human Clinical Data for Gintemetostat (KTX-1001) Demonstrating Target Engagement and Clinical Activity in Multiple Myeloma at ASH 2025 and the Appointment of Dr. Shinta Cheng, M.D., Ph.D., as Chief Medical Officer. Published online December 5, 2025. Accessed December 7, 2025. https://tinyurl.com/3wzem4nx

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  • Ray Dalio warns that America is on track for a ‘debt death spiral.’ Are your assets safe?

    Ray Dalio warns that America is on track for a ‘debt death spiral.’ Are your assets safe?

    Amal Alhasan / Getty Images

    Moneywise and Yahoo Finance LLC may earn commission or revenue through links in the content below.

    The early 1970s were a turbulent time in America — marked by soaring inflation, an oil crisis and a sharp drop in stock prices that left investors scrambling for safe havens.

    And, according to billionaire investor Ray Dalio, history may be repeating itself. Surging prices and massive government spending could prompt investors to once again question the value of fiat currencies and the paper assets tied to them (1).

    “It’s very much like the early ’70s … where do you put your money in?” Dalio said at the Greenwich Economic Forum (2). “When you are holding money, and you put it in a debt instrument, and when there’s such a supply of debt and debt instruments, it’s not an effective storehold of wealth.”

    Dalio has long warned about the sheer size of America’s national debt, now hovering around $37.86 trillion and climbing. He has described the situation as a potential “debt death spiral” — where the government must borrow just to pay the interest on existing debt. Over time, this process accelerates.

    If that number feels abstract, Dalio has a more personal warning.

    The asset he’s talking about is something nearly everyone holds in one way or another, whether in bank accounts or under mattresses: the U.S. dollar.

    In a recent post on X, Dalio shared a Q&A with the Financial Times (3). When asked what would happen to bonds and the dollar if a politically weakened Federal Reserve lets inflation run hot, his answer was blunt:

    “It would lead bonds and the dollar to go down in value and if not rectified, would lead to them being an ineffective storehold of wealth and the breaking down of the monetary order as we know it.”

    That comment couldn’t have come at a more sensitive time for the Federal Reserve. President Donald Trump has repeatedly attacked Chair Jerome Powell and is searching for a replacement.

    Treasury Secretary Scott Bessent told CNBC in late November, “I think there’s a very good chance that the president will make an announcement before Christmas … I think it’s time for the Fed just to move back into the background, like, it used to do, calm things down and work for the American people (4).”

    The President has also come under fire for attempting to oust Fed governor Lisa Cook, the first time a president has sought to remove a governor in the central bank’s 112-year history. Cook sued to keep her job, and it was ruled she could continue in her post (5).

    In the midst of this turbulence, Dalio warned that if investors begin to believe the Fed will artificially hold rates too low, it could trigger “an unhealthy decline in the value of money.”

    To be sure, that decline may already be underway. The U.S. Dollar Index, which tracks the dollar against a basket of major foreign currencies, tumbled 10.8% in the first half of 2025 — its worst performance since 1973, when Richard Nixon was president. (6)

    Meanwhile, inflation continues to chip away at Americans’ purchasing power. According to the Federal Reserve Bank of Minneapolis, $100 in 2025 buys what just $12.05 could in 1970 — a sobering reminder that the dollar hasn’t been a very effective “storehold of wealth” for decades (7).

    Experts are also warning of ‘stagflation,’ a term used to describe an era when GDP growth is moderate, inflation is high, and employment rates are taking a hit (8).

    As Dailo notes, the late 70s and early 80s stand as a classic example of this stagnant economic trend. Today, economic measures are worrying: Inflation is still rising and outpacing the Fed’s predictions. The unemployment rate is rising, particularly for new grads. Perhaps most worrying of all, the national debt has just hit $38.4 trillion, and investors warn that the country may be headed into a spiral where the government borrows even more just to meet the interest on current payments.

    The good news? Dalio revealed one asset he believes can help safeguard your wealth from what’s coming.

    Read more: Warren Buffett used 8 solid, repeatable money rules to turn $9,800 into a $150B fortune. Start using them today to get rich (and stay rich)

    Dalio’s answer is simple: gold.

    “Gold is a very excellent diversifier in the portfolio,” he said (9).

    “If you look at it just from a strategic asset allocation perspective, you would probably have something like 15% of your portfolio in gold … because it is the one asset that does very well when the typical parts of the portfolio go down.”

    Gold’s appeal is straightforward. Unlike fiat currencies, it can’t be printed at will by central banks. It’s also long been viewed as the ultimate safe haven — and has proven its mettle this year by hitting record high prices. Gold performance is not tied to any one country, currency or economy. When markets wobble, or geopolitical tensions flare, investors tend to flock to gold, driving prices higher.

    Dalio isn’t alone in that view. Jeffrey Gundlach, founder of DoubleLine Capital and widely known as the “Bond King,” recently said that a 25% portfolio allocation to gold “is not excessive,” calling the metal “an insurance policy” that’s likely to remain “in a winning mode” amid ongoing dollar weakness.

    Over the past twelve months, gold prices have skyrocketed, and some investors predict even higher prices in 2026.

    If you want to get in on the action, one way to invest in gold that also provides significant tax advantages is to open a gold IRA with the help of Goldco.

    Gold IRAs allow investors to hold physical gold or gold-related assets within a retirement account, which combines the tax advantages of an IRA with the protective benefits of investing in gold, making it an attractive option for those looking to potentially hedge their retirement funds against economic uncertainties.

    With a minimum purchase of $10,000, Goldco offers a 1-day IRA set-up, price match guarantee, highest buy-back guarantee, award-winning customer service and access to a library of retirement resources.

    Plus, the company will match up to 10% of qualified purchases in free silver. Just keep in mind that gold is often best used as one part of a well-diversified portfolio.

    Gold isn’t the only asset investors turn to during inflationary times. Real estate has also proven to be a powerful hedge.

    When inflation rises, property values often increase as well, reflecting the higher costs of materials, labor and land. At the same time, rental income tends to go up, providing landlords with a revenue stream that adjusts for inflation.

    Over the past five years, the S&P Cotality Case-Shiller U.S. National Home Price NSA Index has jumped by 49%, reflecting strong demand and limited housing supply (10).

    Of course, high home prices can make buying a home more challenging, especially with mortgage rates still elevated. And being a landlord isn’t exactly hands-off work — managing tenants, maintenance and repairs can quickly eat into your time (and returns).

    The good news? You don’t need to buy a property outright — or deal with leaky faucets — to invest in real estate today. Crowdfunding platforms like Arrived offer an easier way to get exposure to this income-generating asset class.

    Backed by world-class investors like Jeff Bezos, Arrived allows you to invest in shares of rental homes with just $100, all without the hassle of mowing lawns, fixing leaky faucets or handling difficult tenants.

    The process is simple: browse a curated selection of homes that have been vetted for their appreciation and income potential. Once you find a property you like, select the number of shares you’d like to purchase and then sit back as you start receiving any positive rental income distributions from your investment.

    Another option is Homeshares, which gives accredited investors access to the $35 trillion U.S. home equity market — a space that’s historically been the exclusive playground of institutional investors.

    Homeshares allows accredited investors to gain direct exposure to a portfolio of owner-occupied homes in top U.S. cities through their U.S. Home Equity Fund — without the hassles of buying, owning or managing property.

    The fund focuses on homes with substantial equity, using Home Equity Agreements (HEAs) to let homeowners access liquidity without taking on debt or interest payments. This creates an attractive, low-maintenance investment vehicle for retirement savers, with a minimum investment of $25,000.

    With risk-adjusted target returns of 14% to 17%, the U.S. Home Equity Fund offers investors access to America’s largest store of household wealth.

    And for a limited time, Homeshares will provide Moneywise readers an exclusive 5% bonus for IRA investments.

    It’s easy to see why great works of art tend to appreciate over time. Supply is limited, and many famous pieces have already been snatched up by museums and collectors. That scarcity also makes art an attractive option for investors looking to diversify and preserve wealth during periods of high inflation.

    For example, in 2022 — shortly after U.S. inflation hit a 40-year high — a collection of art owned by the late Microsoft co-founder Paul Allen sold for $1.5 billion at Christie’s New York, making it the most valuable collection in auction history (11).

    Historically, this alternative asset has been restricted to high rollers like Allen, but that’s quick. changing.

    With Masterworks — a platform for investing in shares of blue-chip artwork by renowned artists, including Pablo Picasso, Jean-Michel Basquiat and Banksy — you can get a start with art. It’s easy to use, and Masterworks has had 25 successful exits to date.

    After signing up, all you have to do is browse their impressive portfolio of paintings and choose how many shares you’d like to buy. Masterworks will handle all the details, from purchase and procurement all the way to storage and sale.

    Masterworks has distributed roughly $61 million back to investors, including the principal. New offerings have sold out in minutes, but you can skip their waitlist here.

    Note that investing involves risk. See Reg A disclosures here: masterworks.com/cd.

    We rely only on vetted sources and credible third-party reporting. For details, see our editorial ethics and guidelines.

    CNBC (1), (4); @Bloomberg Podcasts (2) @RayDalio (3); Fortune (5); Bloomberg Originals (6); Federal Reserve Bank of Minneapolis (7); Forbes (8); Bloomberg Television (9); S&P Global (10); Christie’s (11)

    This article provides information only and should not be construed as advice. It is provided without warranty of any kind.

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  • What bridal designer Hayley Paige says she learned from starting over

    What bridal designer Hayley Paige says she learned from starting over

    Bridal designer Hayley Paige’s career path hasn’t always been smooth.

    Paige, 39, has been designing wedding dresses from a young age, she tells CNBC Make It, and she started her namesake bridal line in 2011 with her former employer, bridal house JLM Couture.

    Her career took a turn in 2021 when she lost ownership of her professional name and her intellectual property during a four-year legal battle with JLM Couture.

    Last year, Paige was able to buy back the rights to her name, intellectual property and social media accounts in a settlement agreement after JLM Couture filed for bankruptcy.

    Since then, she’s relaunched her bridal brand and founded an organization, A Girl You Might Know Foundation, dedicated to helping other creatives learn about and protect their legal rights.

    Working in a creative industry may seem glamorous, but Paige has some “unsexy” advice for young artists: “You have to invest in learning the bare bones of business, and how to protect yourself.”

    What she’s learned about business

    A major lesson Paige learned through her experience is that “there’s just so much on the business side that you really have to be patient with” before leaping into a new venture, she says.

    One piece of advice that Paige used to subscribe to is that once you have an idea, you should “get out there and do it” and “figure it out as you go,” she says.

    She understands the sentiment, she says: oftentimes people “get caught up in the details of perfectionism,” which can hold them back from pursuing their goals.

    However, given what she learned from her legal battle, Paige now advocates for a more cautious approach.

    Before launching a business venture, entering a partnership or signing a contract, “you have to take a beat to really make sure you’re stepping out with the right foot forward,” Paige says.

    “You can’t be so eager to just get out there that you don’t have your trademark, you don’t have your copyrights, you don’t have your LLC set up, you’re exposed with liability, you’re getting into partnerships without contracts, or with bad contracts,” she continues.

    After Paige regained ownership of her name and trademark, she spent several months setting up LLCs and ensuring that her creative rights were protected before relaunching her brand.

    It’s much harder to “go back and fight for things” once you’ve already set a precedent, according to Paige.

    Her approach to leadership

    Rebuilding her brand also taught Paige a lot about what kind of boss she wanted to be, she says.

    “I’ve always been somebody that I want people to enjoy working with me, because I feel like they will do their best work when they feel passionate about it, and they’re being treated with respect and acknowledged,” she says.

    Integrity is a key aspect of her leadership philosophy: Paige says starting over gave her the opportunity to build her brand on a “foundation of morals.”

    This time around, she’s also focused on building healthy partnerships, she says. Paige now works with Australia-based bridal company Madi Lane Bridal Group, which serves as the exclusive manufacturing, distribution and sales partner for her new bridal line.

    Paige still feels she has a lot to learn — “even to this day, after launching a small business and a nonprofit, there’s still so much I don’t know,” she says — but she’s committed to honing her “creative and strategic governance” skills.

    “Everything you do really has to be methodical and strategized and really thought through,” Paige says.

    Want to stand out, grow your network, and get more job opportunities? Sign up today for Smarter by CNBC Make It’s new online course, How to Build a Standout Personal Brand: Online, In Person, and At Work. Learn how to showcase your skills, build a stellar reputation, and create a digital presence that AI can’t replicate.

    Plus, sign up for CNBC Make It’s newsletter to get tips and tricks for success at work, with money and in life, and request to join our exclusive community on LinkedIn to connect with experts and peers.

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  • Married millennials, here comes crypto divorce cliff

    Married millennials, here comes crypto divorce cliff

    Fizkes | Istock | Getty Images

    Divorce always raises thorny questions of how to divide marital property. In most cases, the remedy is pretty straightforward, requiring a surgical split between the two parties’ assets — although you can’t do that with the family dog or aquarium. But if you thought deciding who gets the dog was complicated, here comes cryptocurrency.

    With the crypto wealth accumulation phase still new within many households, and the recent sharp decline in digital assets including bitcoin and ether dinging the confidence of investors who had just seen record highs, the path forward is murky. But for many married Americans, the current price of crypto doesn’t even register as an issue. That’s because the assets are easily squirreled away from an unsuspecting spouse.

    “In divorce cases, crypto is creating the same headaches we’ve long seen with offshore accounts, except now the assets can be moved instantly and invisibly,” said Mark Grabowski, professor of cyber law and digital ethics at Adelphi University and author of several books about cryptocurrencies. He added that the problem is that ownership isn’t determined by a name on an account — it’s determined by who holds the private keys.

    “If one spouse controls the wallet, they effectively control the assets,” Grabowski said.

    Lawyers now have to subpoena exchanges, trace transactions on the blockchain, and determine whether coins were purchased before or during the marriage.

    “Without that transparency and given the lack of reporting standards, it’s easy for one spouse to hide or underreport holdings. Courts are still catching up,” Grabowski said.

    In theory, though, a crypto divorce should work like any other. Renee Bauer, a divorce attorney who has dealt with crypto splits, says the biggest question couples fight about is simple on the surface: who gets the wallet?

    “That question opens the door to a mess of complications that traditional property division never had to deal with,” Bauer said.

    The first challenge is figuring out what actually exists.

    “A retirement account comes with statements. A house has an address. Crypto may be sitting in an online exchange or in a hardware wallet that one spouse conveniently forgot to mention,” Bauer said.

    Tracing it then becomes part detective work and part digital forensics. Once the digital asset is authenticated, hashing out custody comes next.

    “Some spouses want to keep the digital wallet intact, especially if they are the one who managed it during the marriage, while others want a clean monetary split,” Bauer said.

    Courts are still figuring out the best way to handle this.

    “There is also the security piece. If one spouse hands over private keys, they are effectively turning over total control. If they refuse, the court has to decide how to enforce access,” Bauer said.

    She recounts seeing one lawyer who didn’t know much about crypto try to give the other spouse credit for the value of the bitcoin in another asset, not recognizing it’s not so simple, nor fair.

    “Many divorce lawyers are slow to catch up and don’t even ask for disclosure. In my state of Connecticut, there isn’t a spot for crypto specifically on the financial affidavits. And for some, that could mean missing a valuable asset if they aren’t looking for it,” Bauer said.

    Crypto hunters, PIs of digital asset divorce era

    One of the few companies that can help locate a missing asset is BlockSquared Forensics. Ryan Settles, founder and CEO of the Texas-based company, says that the need for his services has increased exponentially since he founded his company in 2023. BlockSquared is dedicated exclusively to the crypto aspects of family law and divorce.

    If a spouse (generally women, Settles says) suspects their partner is hiding crypto, their attorney may call in BlockSquared, which does anything from simple asset verification to deep investigations, tracing crypto across continents and into the murky world of wallets and exchanges. Settles’ company will then present the spouse with a “storyboard” that traces and timestamps the movement of cryptocurrencies.

    Investigating whether one spouse has crypto is becoming increasingly common, he says, “especially folks involved in high-net-worth divorces and individuals with high net worth.”

    Ryan Settles, founder and CEO of the Texas-based company BlockSquared Forensics, which offers services from simple asset verifications to deep investigations, often for women going through divorces who were unaware of spouses’ crypto holdings.

    Ryan Settles

    Ferreting out crypto in a divorce is only going to become more common. Settles noted that millennials hold the highest amount of crypto, and over the next six months, this age group will be approaching peak divorce years, converging with increased crypto holdings.

    Another aspect Settles looks at is tax liability for the spouse, making sure that gets addressed during the divorce.

    “There are a significant number of tax issues that most people, even attorneys, are not even familiar with,” Settles says, adding that the number of taxable events and reporting requirements from even a single transaction can come as a surprise to even the most seasoned litigators.

    “Most attorneys don’t understand it, don’t understand the terminology. There is a whole lot of trust without verification going on,” Settles said.

    Many of his cases involve wives who were not only unaware of their husband’s crypto dabbling, but when the assets are finally split, can be socked with a massive tax bill from capital gains.

    “Unlike a savings account, the value of crypto can swing wildly in a single day,” Bauer said. “Selling crypto to divide proceeds can trigger capital gains. Holding it can trigger new arguments when value changes,” Bauer added.

    Relatively relaxed Internal Revenue Service reporting requirements for crypto have not helped, though they are set to get stricter starting with the 2025 tax year.

    “There are so many pieces. There are a lot of attorneys doing nod and smile and pretend to understand,” Settles said.

    But companies like his are usually brought in only when there is a good suspicion of a spouse hiding significant crypto assets, he said. With a retainer fee of $9,000 and investigations that can cost $50,000, Settles says his services often cost more than an attorney.

    Hard questions about crypto property splits

    Roman Beck, a professor at Bentley University, where he directs the Crypto Ledger Lab, says that because this is a relatively new area, it’s best to look at it as courts not dividing the digital wallet but instead the assets the wallet controls.

    “The law treats crypto much less exotically than people think. The starting point is simple: for tax and most property-law purposes, cryptocurrency is treated as property, not as money,” Beck said.

    In divorce, that means bitcoin, ether, stablecoins, and NFTs acquired during the marriage are usually part of the marital estate, just like a brokerage account or a second home, with how that property is split depending on the state.

    “Courts don’t split wallets, they split value,” Beck said.

    The real legal question is not “Who gets the wallet?” he said, but ‘How do we allocate the economic value the wallet represents, and who is trusted with technical custody afterward?”

    This leaves courts and lawyers to do one of three things: split the holdings on-chain, sell and split fiat, or offset with other assets.

    “From a technical point of view, a wallet is just a set of private keys, often spread across hardware devices, mobile apps, or even seed phrases on a piece of paper. You cannot safely ‘share’ a hardware wallet or a private key after divorce,” Beck said.

    Another wrinkle in a crypto divorce is the volatility of the underlying asset, with price swings in the currency making it more difficult for couples to agree on timing of a split, both as a couple and for the digital assets. In the past two months alone, bitcoin fell from a high over $126,000 to the low $80,000s, a 35% decline, and saw its year-to-date gains wiped out, with plenty of wild daily swings.

    If couples are thinking rationally and not emotionally, among the simplest solutions would be splitting the wallet on a chain to create two wallets for each of the divorced partners so they can continue holding their share of cryptos, or drawing up a legal agreement that gives shares of a wallet to each party.

    “They would not have to sell immediately,” Beck said.

    However, often one party is not familiar with holding a wallet and thus not comfortable with that solution.

    Similar to a house jointly owned which a divorcing couple may not want to bring to the market at a bad time, a couple could also agree to turn over crypto holdings to trusted third party to act as agent on behalf of both and to sell the crypto once the market has improved — once a certain agreed upon minimum value has been reached.

    But Beck added that while from an economic and technical point of view there is no barrier preventing a divorcing couple from keeping crypto assets using any of these methods to allocate a legal percentage to each partner and delay liquidation until market conditions improved, both parties need to agree, and “most just want to be done,” he said.

    Blockchain ledger transparency and the courts

    One positive it that despite crypto’s reputation as a haven of anonymity, other aspects of digital assets work well for divorce proceedings.

    “Public blockchains like bitcoin and ethereum are transparent ledgers. Every transaction is recorded forever. In other words, on-ledger data analytics turns the blockchain into a very patient financial witness,” Beck said. “That leaves a perfect audit trail if you know how to read the chain. … The real frontier isn’t the law, it’s the forensics,” he added.

    Crypto’s adoption by many Americans — surveys in recent years from Gallup and Pew Research estimate that 14% to 17% of U.S. adults have owned cryptocurrency — is forcing family law to become more data-driven.

    “The combination of transparent ledgers and powerful analytics gives lawyers and judges better tools to reconstruct financial behavior than they ever had with cash. The policy question going forward is not whether we can trace, but how far courts will go in requiring that level of scrutiny in everyday divorces,” Beck said.

    Still, that doesn’t mean people won’t keep trying to hide assets. Settles says that often within 20 minutes he’ll see movement on the ledgers.

    “They’ll start scrambling their assets, moving things, hiding things, moving them to tumblers. It’s quite fascinating,” Settles said.

    And traceable.

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