Category: 3. Business

The addition of azacitidine (Vidaza) and ventoclax (Venclexta) to tagraxofusp (Elzonris) was feasible in patients with first-line or relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN), and may increase both complete response (CR) rates and the number of patients proceeding the transplant compared with tagraxofusp alone, according to results from a phase 2 trial (NCT03113643) presented during the 2025 ASH Annual Meeting.¹

In previously untreated patients (n = 16), at a median follow-up of 16.7 months (95% CI, 8.6-26.6), the composite CR rate was 88%, comprising best responses of CR (50%), CR with incomplete hematologic recovery (CRi; 38%) and clinical CR (0%). The overall response rate (ORR) was 94%, including 1 partial response (PR; 6%). The median duration of response (DOR) was not reached (NR). No patients achieved stable disease (SD) or experienced disease progression (PD), and 1 patient was not evaluable due to early death.

For patients with relapsed/refractory disease (n = 11), the composite CR rate was 64%; this included CR, CRi and CRc rates of 9%, 36% and 18%, respectively. The ORR was comprised entirely of CRs. SD was achieved by 27% of patients and 9% experienced PD. The median DOR was 7.2 months (95% CI, 5.5-36.4%). Of note, all but one patient in this cohort had disease relapse or death; the remaining patient had a median follow-up of 42.4 months.

Notably, 63% and 55% of patients in the first-line and relapsed/refractory groups, respectively, proceeded directly to allogeneic stem cell transplant (SCT), including 10 of the 11 patients age 75 or older in the first-line cohort.

Regarding safety, investigators reported that the toxicity profile of the tagraxofusp, azacitidine, and venetoclax triplet was as expected and consistent with prior studies of this regimen in patients with acute myeloid leukemia (AML).

Moreover, the rate of capillary leak syndrome (CLS) was equivalent or lower with the triplet than with single-agent tagraxofusp, according to historical data. Overall, the CLS rate with the triplet was 14.8%; respective rates of grade 2 and 3 CLS were 11.1% and 3.7%, and no grade 4 or 5 CLS events occurred. All CLS events occurred in cycle 1 and were manageable with albumin and diuresis.

“There is a high rate of known prior and concomitant hematologic malignancies in these patients with BPDCN,” lead study author Andrew A. Lane, MD, PhD, stated in an oral presentation of the data. “The addition of agents like azacitidine and venetoclax [to tagraxofusp] is attractive because it can have activity in those diseases that may not be as high with tagraxofusp alone. [Therefore,] we think [that this triplet] is an effective new treatment option for patients with BPDCN.”

Lane serves as a physician and director of the Blastic Plasmacytoid Dendritic Cell Neoplasm Center at Dana-Farber Cancer Center, and is an associate professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

Key Takeaways From a Phase 2 Study of Tagraxofusp/Azacitidine/Venetoclax

• This triplet regimen was found to be feasible in both previously untreated and relapsed/refractory BPDCN.

• The regimen’s safety profile was as-expected and was deemed comparable to that of the triplet regimen in prior evaluations in AML.

• Composite CR rates with the triplet in previously untreated and relapsed/refractory patient populations were 88% and 64%, respectively.

What was the rationale for evaluating this triplet regimen both upfront and in the relapsed/refractory setting?

“We previously found in the laboratory that tagraxofusp resistance in AML and BPCDN is mediated by DNA methylation and silencing of diphthamide genes, which are necessary for the cytotoxicity of diphtheria toxin, and that tagraxofusp resistance can be reversed with azacitidine treatment,” Lane explained. “We’ve also shown that BPDCN is highly dependent on BCL2 and sensitive to venetoclax.”

Lane also noted clinical data from a phase 1b study (NCT03113643), which evaluated the safety of tagraxofusp plus azacitidine with or without venetoclax in AML. Results showed that 69% of patients with first-line AML who received the triplet (n = 26) achieved a best response of CR, 19% achieved a CRi, and 12% achieved a morphologic leukemia-free state. The median time to best response among these 18 patients was 55 days. Furthermore, there was no indication of increased toxicity with tagraxofusp with azacitidine with or without venetoclax in combination, and adverse effects (AEs) related to tagraxofusp were also as expected.

How was this phase 2 trial designed?

This phase 2 study enrolled patients 18 years of age or older with previously untreated or relapsed/refractory BPDCN onto separate cohorts. Patients were required to have albumin levels of 3.2 g/L or greater, alanine aminotransferse (ALT)/aspartate aminotransferase (AST) levels below 2.5 x the upper limit of normal (ULN), bilirubin levels below 1.5 x ULN, and creatinine levels below 1.5 x ULN; an ECOG performance status of 2 or lower; and normal cardiac ejection fractions. Screening lumbar puncture was required. Patients with asymptomatic central nervous system disease were permitted to enroll and receive intrathecal (IT) chemotherapy, and IT prophylaxis was both permitted and encouraged for all.

Eligible patients received 12 µg/kg of tagraxofusp on days 4 through 6, 75 mg/m2 of azacitidine on days 1 through 7, and 400 mg of venetoclax on days 1 through 21 for a 28-day cycle. Venetoclax ramp-up occurred on days 1 through 3 of cycle 1. Notably, patients were hospitalized in cycle 1 until the completion of tagraxofusp administration to monitor for CLS. Outpatient treatment was allowed starting at cycle 2 and beyond.

The study’s primary end point was safety, and key secondary end points included response rate, estimated progression-free survival (PFS) and overall survival (OS). Response evaluation in marrow, skin, and the extramedullary space was also conducted.

What were the baseline characteristics of patients in this study?

In the overall patient population (n = 27), the median age was 70 years (range, 21-81). Most patients were male (93%), White (93%), had non-Hispanic ethnicity (78%), and an ECOG performance status of 1 (63%). “Skin only” disease occurred in 30% of patients. Overall, 37% of patients had a prior or concomitant hematologic malignancy, including chronic myelomonocytic leukemia (n = 4), myelodysplastic syndrome (n = 4), or a myeloproliferative neoplasm (n = 3). Mutations in TET2 (37%), ASXL1 (26%), RNA splicing factor (19%), NRAS/KRAS/FLT3 (15%), and TP53 (7%) were observed.

For patients with relapsed/refractory disease, prior therapies included tagraxofusp (64%), pivekimab sunirine (IMGN632; 36%), venetoclax (27%, 2 with a hypomethlyating agent), and SCT (36%).

Patients with previously untreated BPDCN received a median of 2.5 cycles (range, 1-4) of treatment. In the relapsed/refractory group, the median number of cycles was 2 (range, 1-5).

What additional safety and efficacy data were reported at the meeting?

For patients with previously untreated BPDCN, the median OS, PFS, and DOR were all NR. The 2-year PFS and OS rates were 65% (95% CI, 40%-91%) and 53% (95% CI, 30%-80%), respectively. In the relapsed/refractory group, the median OS was 8.4 months (95% CI, 4.8-21.7) and the median PFS was 6.3 months (95% CI, 2.2-11.2). The median DOR was 7.2 months (95% CI, 5.5-36.4).

In the overall patient population, the most common grade 3 or higher treatment-related AEs were thrombocytopenia (63%), decreased white blood cell count (59%), neutropenia (48%), anemia (19%), and hypoxia (11%). Other AEs included increased ALT levels, increased AST levels, atrial fibrillation, febrile neutropenia, hyperglycemia, hypophosphatemia, multi-organ failure, sinus tachycardia, and syncope (4% each).

No cases of veno-occlussive disease were reported. In the overall patient population, the all-cause mortality rates at 30- and 60-days were 3.7% and 7.4%, respectively. One patient with first-line BPDCN died in cycle 1 due to multi-organ failure, and 1 patient with relapsed/refractory disease died after cycle 1 due to disease progression. The median time from the start of cycle 1 to cycle 2 was 33 days.

Disclosures: Lane received consultancy fees from ProteinQure, IDRx, Cimeio, Qiagen, Jnana Therapeutics, Stemline, and AbbVie. He also holds stock options in Stelexis BioSciences and Stemline.

References

1. Lane AA, Luskin M, Keating J, et al. Tagraxofusp, azacitidine, and venetoclax (TAG-AZA-VEN) triplet therapy shows efficacy, tolerability, and transplant potential in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN): results of a phase 2 trial. Blood. 2025;146(suppl 1):653. doi:10.1182/blood-2025-653
2. Lane AA, Garcia JS, Raulston EG, et al. Phase 1b trial of tagraxofusp in combination with azacitidine with or without venetoclax in acute myeloid leukemia. Blood. 2024;8(3):591-602. doi:10.1182/bloodadvances.2023011721

The articles, information, and content displayed on this webpage may
include materials prepared and provided by third parties. Such
third-party content is offered for informational purposes only and
is not endorsed, reviewed, or verified by Morningstar.

Morningstar makes no representations or warranties regarding the
accuracy, completeness, timeliness, or reliability of any third-party
content displayed on this site. The views and opinions expressed in
third-party content are those of the respective authors and do not
necessarily reflect the views of Morningstar, its affiliates, or employees.

Morningstar is not responsible for any errors, omissions, or delays
in this content, nor for any actions taken in reliance thereon.
Users are advised to exercise their own judgment and seek independent
financial advice before making any decisions based on such content.
The third-party providers of this content are not affiliated with
Morningstar, and their inclusion on this site does not imply any
form of partnership, agency, or endorsement.

Shareholders to Receive $21.20 Per Share in Cash Representing a 40.0% Premium to Closing Price on December 8, 2025

HONOLULU – Alexander & Baldwin, Inc., (NYSE: ALEX) ( “A&B” or the “Company”), a Hawaiʻi-based owner, operator and developer of high-quality commercial real estate in Hawaiʻi, today announced that it has entered into a definitive merger agreement in which a joint venture formed by MW Group and funds affiliated with Blackstone Real Estate and DivcoWest (collectively, the “Investor Group”) will acquire all outstanding A&B common shares for $21.20 per share in an all-cash transaction with an enterprise value of approximately $2.3 billion, including outstanding debt. As a result of this transaction, A&B will become a private company.

A&B is the largest owner of high-quality, grocery-anchored shopping centers in Hawai‘i. The Company’s portfolio consists of approximately 4.0 million square feet of commercial space, including 21 retail centers, 14 industrial assets and four office properties, as well as fee interests in 146 acres of ground lease assets.

“For 155 years, A&B has grown alongside Hawaiʻi, shaped by the people, values and communities that define these islands,” said Lance Parker, President and Chief Executive Officer of A&B. “Today, we are taking an important step toward our long-term vision for A&B as stewards of Hawai‘i’s premier commercial real estate. As a private company supported by the deep real estate expertise and experience of our new ownership group, A&B will have greater capacity to serve its tenants and communities. In our next chapter, we will continue focusing on real estate that supports the daily lives of residents, overseeing our properties with care and remaining steadfast in our role as partners for Hawai‘i.”

“We’re pleased to reach this agreement, which delivers significant, immediate and certain value to our shareholders while strengthening A&B’s ability to serve the diverse needs of communities across Hawai‘i,” said Eric Yeaman, Chairman of the A&B Board. “The Board is confident that today’s news is in the best interests of all of A&B’s stakeholders. It delivers a substantial cash premium for shareholders and long-term benefits for our valued employees, tenants and communities.”

“As a Hawai‘i-grown company founded over 35 years ago, we have seen firsthand the community contributions and lasting value that Alexander & Baldwin has created across generations,” said Stephen Metter, CEO at MW Group. “We look forward to supporting the Company’s legacy and magnifying our collective impact on the communities we serve.”

Blackstone Real Estate has a long history of responsible ownership in Hawai‘i, including iconic hospitality properties, such as Grand Wailea, The Ritz-Carlton Maui, Kapalua, Turtle Bay and Hilton Hawaiian Village, as well as retail property Pearlridge Center and high-quality rental housing on O‘ahu.

“We’re excited to reach this agreement, which deepens our commitment to Hawai‘i and our long-standing support for its local businesses. Our approach has always centered on operating responsibly and creating new opportunities for community members, including the more than 9,000 jobs created and supported by our investments in Hawai‘i,” said David Levine, Co-Head of Americas Acquisitions for Blackstone Real Estate. “We have a deep appreciation for what the Alexander & Baldwin management team has built, and we look forward to working together going forward.”

“Alexander & Baldwin has built an outstanding portfolio and we look forward to working with our partners and the Company to help continue its success,” said Caleb Cragle, Head of Strategic Investments, DivcoWest.

Continuing A&B’s Legacy as Partners for Hawai‘i

The Investor Group is aligned with the following principles to further the Company’s vision for building a better Hawai‘i, today and for the future:

• Maintaining A&B’s Strong Local Focus: Following the closing of the transaction, A&B will retain its name, brand and Honolulu headquarters.
• Continued Leadership From Local Team: The Company will continue to be led by a Hawai‘i-based team and is committed to strengthening the relationships and community connection that have driven its long-term success.
• Enhancing Existing Portfolio of Properties: A&B will continue to maintain its properties at high standards of quality for its tenants and community members. The Investor Group intends to invest over $100 million across the portfolio to enhance the properties and reinforce their essential role in the communities they serve.

Transaction Details
Under the terms of the agreement, A&B shareholders will receive $21.20 per share in cash for each share of A&B common stock they own. This amount represents a 40.0% premium to A&B’s closing stock price on December 8, 2025, the last full trading day prior to the transaction announcement.

The transaction, which was unanimously approved by the A&B Board of Directors, is expected to close in the first quarter of 2026, subject to customary closing conditions including approval by the Company’s shareholders.

Upon completion of the transaction, A&B’s common stock will no longer be listed on the NYSE.

A&B also announced today that its Board of Directors approved a fourth quarter 2025 dividend of $0.35 per share. The dividend is payable on January 8, 2026, to shareholders of record as of the close of business on December 19, 2025. Under the terms of the merger agreement, the per-share consideration that shareholders will receive at the closing of the transaction will be reduced to reflect this dividend.

Advisors
BofA Securities is serving as A&B’s exclusive financial advisor, and Skadden, Arps, Slate, Meagher & Flom LLP and Cades Schutte LLP are serving as legal advisors. Joele Frank, Wilkinson Brimmer Katcher is serving as strategic communications advisor.

Wells Fargo and Eastdil Secured are acting as Blackstone’s financial advisors. Simpson Thacher & Bartlett LLP and Carlsmith Ball LLP are serving as Blackstone’s legal counsel.

Gibson, Dunn & Crutcher LLP is serving as DivcoWest’s legal counsel.

ABOUT ALEXANDER & BALDWIN
Alexander & Baldwin, Inc. (NYSE: ALEX) (A&B) is the only publicly-traded real estate investment trust to focus exclusively on Hawai‘i commercial real estate and is the state’s largest owner of grocery-anchored, neighborhood shopping centers. A&B owns, operates and manages approximately 4.0 million square feet of commercial space in Hawai‘i, including 21 retail centers, 14 industrial assets, and four office properties, as well as 146 acres of ground lease assets. Over its 155-year history, A&B has evolved with the state’s economy and played a leadership role in the development of the agricultural, transportation, tourism, construction, residential and commercial real estate industries. Learn more about A&B at www.alexanderbaldwin.com.
About MW Group, Ltd.
MW Group, Ltd. is a privately-held, commercial real estate development company based in Honolulu, Hawai‘i. For more than three decades, the company has led the acquisition, development and management of a diverse portfolio of commercial properties valued at over $1 billion, including retail, industrial, office, self-storage facilities and senior assisted living communities. The company is committed to long-term stewardship, community-building, and creating enduring value through strategic partnerships and operational excellence. Learn more at www.mwgroup.com.

About Blackstone Real Estate
Blackstone is a global leader in real estate investing. Blackstone’s real estate business was founded in 1991 and has US $320 billion of investor capital under management. Blackstone is the largest owner of commercial real estate globally, owning and operating assets across every major geography and sector, including logistics, data centers, residential, office and hospitality. Our opportunistic funds seek to acquire well-located assets across the world. Blackstone’s Core+ business invests in substantially stabilized real estate assets globally, through both institutional strategies and strategies tailored for income-focused individual investors including Blackstone Real Estate Income Trust, Inc. (BREIT). Blackstone Real Estate also operates one of the leading global real estate debt businesses, providing comprehensive financing solutions across the capital structure and risk spectrum, including management of Blackstone Mortgage Trust (NYSE: BXMT).

About DivcoWest
Founded in 1993 by Stuart Shiff, DivcoWest, a DivCore Capital company, is a vertically integrated, real estate investment firm headquartered in San Francisco, with offices in Cambridge, Beverly Hills, Menlo Park, Washington DC, Austin, and New York City. Known for long-standing relationships and experience across the risk-spectrum in innovation markets, DivcoWest combines entrepreneurial spirit with an institutional approach to commercial real estate. DivcoWest aims to create environments that inspire ingenuity, promote growth, and enhance health and well-being. Since inception, DivcoWest and its predecessor have acquired approximately 61 million square feet of commercial space – primarily throughout the United States. DivcoWest’s real estate portfolio currently includes existing and development properties in the office, R&D, lab, industrial, retail, and multifamily spaces. Follow @DivcoWest on LinkedIn.

Contacts:

A&B
Investor Contact:
Clayton Chun
(808) 525-8475
[email protected]
Media Contact:
Tran Chinery
[email protected]
MW Group
Dylan Beesley
Bennet Group Strategic Communications
[email protected]

Blackstone
Jeffrey Kauth
[email protected]
Dylan Beesley
Bennet Group Strategic Communications
[email protected]

DivcoWest
Andrew Neilly
A2N2 Public Relations
925.915.0759
[email protected]
Nancy Amaral
A2N2 Public Relations
925.915.0673
[email protected]
IMPORTANT INFORMATION AND WHERE TO FIND IT
In connection with the transaction, the Company will file a proxy statement on Schedule 14A with the Securities and Exchange Commission (the “SEC”). The Company also may file other documents with the SEC regarding the transaction. This communication is not a substitute for the proxy statement or any other document which the Company may file with the SEC. INVESTORS AND SHAREHOLDERS OF THE COMPANY ARE URGED TO READ THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS THAT ARE FILED OR WILL BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE TRANSACTION. Investors and shareholders may obtain free copies of the proxy statement and other documents that are filed or will be filed by the Company with the SEC (in each case when available) from the SEC’s website (www.sec.gov), or from the Company’s website (https://investors.alexanderbaldwin.com/sec-filings). Alternatively, these documents, when available, can be obtained for free upon written request to the Company at 822 Bishop Street, Honolulu, HI 96813.

PARTICIPANTS IN THE SOLICITATION
The Company and certain of its directors and executive officers may be deemed to be participants in the solicitation of proxies from shareholders of the Company in connection with the transaction. Information regarding the Company’s directors and executive officers is contained in the Company’s proxy statement for its 2025 annual meeting of shareholders, which was filed with the SEC on March 11, 2025, and any subsequent documents filed with the SEC. To the extent the holdings of the Company’s securities by the Company’s directors and executive officers have changed since the amounts set forth in the proxy statement for its 2025 annual meeting of shareholders, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. Additional information regarding the identity of the participants, and their respective direct and indirect interests, by security holdings or otherwise, will be set forth in the proxy statement and other relevant materials to be filed with the SEC in connection with the transaction when they become available. You may obtain free copies of these documents using the sources indicated above.

FORWARD-LOOKING STATEMENTS
This communication includes forward-looking statements, as defined in the U.S. federal securities laws, which involve a number of risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. Words such as “believes,” “expects,” “anticipates,” “intends,” “plans,” “estimates,” “projects,” “forecasts,” and future or conditional verbs such as “will,” “may,” “could,” “should,” and “would,” as well as any other statement that necessarily depends on future events, are intended to identify forward-looking statements. Such forward-looking statements speak only as of the date the statements were made and are neither statements of historical fact nor guarantees of future performance. Forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results and the timing of certain events to differ materially from those expressed in or implied by the forward-looking statements. These factors include, but are not limited to, (i) the risk that the merger may not be completed on the anticipated terms and timing, or at all, including the risk that the required approval of the Company’s shareholders may not be obtained or that the other conditions to completion of the merger may not be satisfied, (ii) potential litigation relating to the merger that could be instituted against the Company or its directors or officers, including the effects of any outcomes related thereto, (iii) the risk that disruptions from the merger will harm the Company’s business, including current plans and operations, including during the pendency of the merger, (iv) the Company’s ability to retain and hire key personnel, (v) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the merger, (vi) risks related to diverting management’s attention from ongoing business operations, (vii) potential business uncertainty, including changes to existing business relationships, during the pendency of the merger that could affect the Company’s financial performance, (viii) certain restrictions under the merger Agreement that may impact the Company’s ability to pursue certain business opportunities or strategic transactions, (ix) the possibility that the merger may be more expensive to complete than anticipated, including as a result of unexpected factors or events, (x) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger, including in circumstances requiring the Company to pay a termination fee, (xi) prevailing market conditions and other factors related to the Company’s REIT status and the Company’s business, and (xii) the risk factors discussed in Part I, Item 1A of the Company’s most recent Form 10-K under the heading “Risk Factors,” Form 10-Q and other filings with the SEC (which are available via the SEC’s website at www.sec.gov). The information in this communication should be evaluated in light of these important risk factors. We do not undertake any obligation to update or review the Company’s forward-looking statements, except as required by law, whether as a result of new information, future developments or otherwise.

No matter how much train fares cost under Great British Railways, no one can accuse the government of wasting money on an expensive redesign.

The logo, branding and livery for the impending renationalised and reformed railway will be unveiled by ministers at London Bridge on Tuesday. It is red, white and, yes, blue.

The Department for Transport said passengers will get their “first look at the future” of Britain’s railways – a future that may ring a few bells. Designed in-house at the DfT, the logo is the GBR name in rail typeface accompanied by the double arrow symbol – what the DfT describes as a “nod to Britain’s proud railway heritage”, rather than a direct lift from British Rail.

The first actual trains to be repainted could arrive from next spring, but fans of pretend ones can see the brand on a Hornby model and a virtual version in the Train Sim World 6 game at London Bridge, and on displays at other leading stations around the country.

The unveiling comes as legislation aimed at reforming the railway is debated in the House of Commons on Tuesday. The government hopes the bill will create a unified, accountable nationalised railway after decades of a fragmented private system.

The transport secretary, Heidi Alexander, said: “The future of Britain’s railways begins today. I’m immensely proud to unveil the new look for Great British Railways as we deliver landmark legislation to nationalise our trains and reform the railway so it better serves passengers.

“This isn’t just a paint job – it represents a new railway, casting off the frustrations of the past and focused entirely on delivering a proper public service for passengers.

“With fares frozen, a bold new look and fundamental reforms becoming law, we are building a railway Britain can rely on and be proud of.”

Seven of England’s former private train operators are already back in public hands, covering a third of all passenger journeys in Great Britain, with the rest due to renationalised by the end of 2027. The new GBR, to be headquartered in Derby, will bring track and train operations together, at arm’s length from the government, and a strengthened passenger watchdog will be set up to monitor service.

The new brand design also features on the GBR ticketing app under development, which the government will roll out as a new one-stop shop for passengers to check on their journeys and to buy tickets for travel across the whole network, without any booking fees. The DfT said the GBR app would also simplify travel for disabled passengers, who will be able to book Passenger Assist services to board and disembark trains in the same app when buying tickets.

skip past newsletter promotion

after newsletter promotion

In October, the design of the new Great British Railways station clock was unveiled, also at London Bridge.

Alex Robertson, the chief executive of the current independent watchdog Transport Focus, said: “As well as what is written into law, the success of GBR will depend on its people and culture, and today gives us a glimpse into what that could look and feel like.”

A first big test for state-controlled services comes from next week when hundreds more LNER trains are added each week on a revamped east coast mainline timetable.

Alexander announced last month that rail fares in England will be frozen in 2026 for the first time in 30 years.

Specialty

Please chooseI’m not a medical professional.Allergy and ImmunologyAnatomyAnesthesiologyBiostatisticsCardiac/Thoracic/Vascular SurgeryCardiologyCritical CareDentistryDermatologyDiabetes and EndocrinologyEmergency MedicineEpidemiology and Public HealthFamily MedicineForensic MedicineGastroenterologyGeneral PracticeGeneticsGeriatricsHealth PolicyHematologyHIV/AIDSHospital-based MedicineI’m not a medical professional.Infectious DiseaseIntegrative/Complementary MedicineInternal MedicineInternal Medicine-PediatricsMedical Education and SimulationMedical PhysicsMedical StudentNephrologyNeurological SurgeryNeurologyNuclear MedicineNutritionObstetrics and GynecologyOccupational HealthOncologyOphthalmologyOptometryOral MedicineOrthopaedicsOsteopathic MedicineOtolaryngologyPain ManagementPalliative CarePathologyPediatricsPediatric SurgeryPharmacologyPhysical Medicine and RehabilitationPlastic SurgeryPodiatryPreventive MedicinePsychiatryPsychologyPulmonologyRadiation OncologyRadiologyRheumatologySubstance Use and AddictionSurgeryTherapeuticsTraumaUrologyMiscellaneous

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

Damian Garde is a reporter at large, live and feature journalism, covering the global drug industry and contributing to STAT’s industry-leading events.

This is the online version of ASH in 30 Seconds, STAT’s report from the American Society of Hematology meeting. Sign up for the email version here. 

It rains in Florida. A lot. This ASH meeting started sunny and wonderful, but quickly turned rainy and miserable. It’s just another reason why ASH should camp itself permanently in San Diego each December.

Study suggests Terns leukemia drug could be successor to Novartis blockbuster

Adam Feuerstein/STAT

Terns Pharmaceuticals reported an update on its targeted leukemia drug that maintained and even boosted high molecular response rates in advanced-stage patients.

WASHINGTON — Commodity Futures Trading Commission Acting Chairman Caroline D. Pham today announced the launch of a digital assets pilot program for certain digital assets, including BTC, ETH, and USDC, to be used as collateral in derivatives markets; guidance on tokenized collateral; and withdrawal of outdated requirements given the enactment of the GENIUS Act. Today’s announcement marks a significant milestone in the expanded adoption of digital assets in regulated markets with appropriate guardrails, and follows the tokenized collateral initiative Acting Chairman Pham launched in September as a part of the CFTC’s Crypto Sprint to implement recommendations in the President’s Working Group on Digital Asset Markets report.

“Under my leadership this year, the CFTC has led the way forward into America’s Golden Age of Innovation and Crypto. This imperative has never been more important given recent customer losses on non-U.S. crypto exchanges. Americans deserve safe U.S. markets as an alternative to offshore platforms, and that’s why last week I announced that spot crypto can now be traded on CFTC registered exchanges,” said Acting Chairman Pham. “Today, I am launching a U.S. digital assets pilot program for tokenized collateral, including bitcoin and ether, in our derivatives markets that establishes clear guardrails to protect customer assets and provides enhanced CFTC monitoring and reporting. The CFTC is also providing regulatory clarity through tokenized collateral guidance for real world assets like U.S. Treasuries, and withdrawing CFTC requirements that are now outdated under the GENIUS Act. As I’ve said before, embracing responsible innovation ensures that U.S. markets are the world leader, and drives progress that will unleash U.S. economic growth because market participants can safely put their dollars to work smarter and go further.” 

“The CFTC’s decision confirms what the crypto industry has long known: That stablecoins and digital assets can make payments faster, cheaper, and reduce risk,” said Paul Grewal, Coinbase Chief Legal Officer. “We applaud Acting Chair Caroline Pham and the CFTC for swiftly recognizing that tokenized innovation is the future of finance, and thank Acting Chair Caroline Pham for her leadership and vision. This major unlock is precisely what the Administration and Congress intended the GENIUS Act to enable—and will allow digital innovation to transform and improve traditional areas of finance. We encourage other regulators to quickly follow suit.”

“Circle applauds Acting Chairman Pham’s breakthrough leadership for derivatives markets and responsible innovation,” said Heath Tarbert, President of Circle. “Deploying prudentially supervised payment stablecoins across CFTC-regulated markets protects customers, reduces settlement frictions, supports 24/7 risk reduction, and advances U.S. dollar leadership through global regulatory interoperability. Enabling near-real-time margin settlement will also mitigate settlement-failure and liquidity-squeeze risks across evenings, weekends, and holidays. Acting Chairman Pham and the Commission have set a course for the future in which the United States will continue to have the safest, deepest, and most trusted global derivatives markets.”

“Today marks an important milestone in the history of the crypto industry—we have been given regulatory certainty for the future,” said Kris Marszalek, Co-Founder and CEO of Crypto.com. “The CFTC guidance on tokenized collateral is the latest example of Acting Chairman Pham delivering on the promise of President Trump to make the United States the ‘crypto capital of the world.’ Acting Chairman Pham should be commended for these leadership efforts. For years, we have been able to offer tokenized collateral in markets other than the United States. It has only been because of the leadership of Acting Chairman Pham and the CFTC’s exclusive jurisdiction over our CFTC-regulated clearinghouse that we will now be able to use tokenized collateral to support our CFTC-regulated crypto and predictions market products, as well as our margined derivatives. This means 24/7 trading is a reality in the United States. We are fully open for business and are excited for this new chapter.”

“The CFTC’s actions mark a pivotal moment for integrating digital assets into regulated derivatives markets. By recognizing tokenized digital assets—including stablecoins—as eligible margin, the CFTC is providing the regulatory clarity needed to move the industry forward,” said Jack McDonald, SVP of Stablecoins at Ripple. “This step will unlock greater capital efficiency and solidify U.S. leadership in financial innovation. At Ripple, we look forward to continuing to partner with the CFTC and the industry to ensure the safe and responsible scaling of digital assets.”

Digital Assets Pilot Program and Guidance for Tokenized Collateral

The CFTC’s Market Participants Division, Division of Market Oversight, and Division of Clearing and Risk issued new guidance today on the use of tokenized assets as collateral in the trading of futures and swaps. The guidance highlights that CFTC regulations are technology-neutral, and encourages the analysis of tokenized assets on an individual basis in accordance with the CFTC’s existing regulatory framework and firms’ policies and procedures. The guidance applies to tokenized real world assets, including U.S. Treasury securities and money market funds. Topics include eligible tokenized assets; legal enforceability; segregation, custody and control arrangements; haircuts and valuation; and operational risks.

MPD also issued a no-action position with respect to certain requirements applicable to Futures Commission Merchants (FCMs) that accept non-securities digital assets, including payment stablecoins, as customer margin collateral or hold certain proprietary payment stablecoins in segregated customer accounts. The no-action position provides market participants with regulatory clarity regarding the application of the segregation and capital requirements to FCMs that accept these digital assets as margin collateral, while highlighting the importance of FCMs’ maintaining robust risk management practices. By setting up a framework for registered FCMs to accept and take into account the value of non-securities digital asset customer margin collateral and deposit payment stablecoins as residual interest, the no-action letter establishes a pilot program that fosters responsible financial innovation while providing an opportunity for CFTC staff to closely monitor developments associated with non-securities digital asset collateral.

As set forth in the conditions of the letter, during the first three months from the commencement of an FCM’s reliance on the no-action position, the digital assets that an FCM could accept as margin collateral will be limited to bitcoin, ether, and USDC. In addition, during this initial period, an FCM relying on the no-action letter will be required to provide weekly reporting of the total amount of digital assets held in customer accounts, listing each asset type separately for each of the three customer account classes, and promptly notify CFTC staff of any significant issue affecting the use of digital assets as customer margin collateral. The frequent reporting and notice requirements will provide an opportunity for CFTC staff to assess the proper application of FCM regulatory requirements without unnecessarily limiting the ability of FCMs to accept digital assets as collateral and deposit proprietary payment stablecoins as residual interest in customer accounts.

Finally, MPD withdrew CFTC Staff Advisory No. 20-34, Accepting Virtual Currencies from Customers into Segregation, effective immediately. That advisory, which was issued by MPD’s predecessor division, placed certain restrictions on an FCM’s ability to accept virtual currencies as customer collateral. The substantial developments with respect to digital assets and the use of tokenized collateral in the derivatives markets that occurred in the intervening years since its issuance, including the enactment of the GENIUS Act, have rendered the advisory outdated and no longer relevant. 

These actions are based on significant stakeholder input and public comments, feedback from a CFTC Crypto CEO Forum, and recommendations from the Digital Asset Markets Subcommittee of the Global Markets Advisory Committee, which Acting Chairman Pham sponsors.