FDA Approves IsoPSA® — Cleveland Diagnostics’ Novel Blood-Based Prostate Cancer Test

On December 1, 2025 Cleveland Diagnostics, Inc., a pioneering, commercial-stage precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved the company’s IsoPSA in vitro diagnostic (IVD) kit through the Premarket Approval (PMA) process. IsoPSA is a blood-based test indicated as an aid in the decision for prostate biopsy for men ≥ 50 years of age with elevated PSA levels.

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"FDA approval of our IsoPSA kit marks a significant milestone in Cleveland Diagnostics’ mission to help physicians and patients detect cancer early when it is most treatable and survivable," shared Arnon Chait, PhD, company president and CEO. "We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide."

FDA approval of the IsoPSA test was based on clinical evidence from a large-scale, prospective study conducted at 14 sites across the U.S. and data from supporting analytical validation studies.

Prostate cancer is the second most common cancer in American men, with 1 in 8 diagnosed during their lifetime. In the U.S., greater than 1 million men undergo prostate biopsies each year, yet up to 75% of those follow-up tests are negative for high-grade disease. This diagnostic gap subjects millions to invasive, costly procedures that can produce physical risks, emotional stress, and significant healthcare costs. IsoPSA helps close this gap, giving clinicians and patients a more accurate risk assessment and greater confidence in biopsy decision-making.

"As a practicing urologist, I see firsthand how the limitations of current PSA testing can lead to unnecessary procedures and anxiety for patients and appreciate the critical need for early and accurate risk assessment and testing," added Dr. Aaron Berger, Chief Medical Officer and Director of Clinical Research at Associated Urological Specialists in Chicago. "IsoPSA represents a meaningful advancement, giving physicians a tool that improves risk assessment and helps us make more informed biopsy decisions with greater confidence."

"FDA approval underscores the value and clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high grade cancer," said Dr. Eric Klein, Emeritus Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and Distinguished Scientist at GRAIL, Inc.* "I’m very pleased to see this milestone achieved; it represents the culmination of extensive study and test development over the past decade."

The IsoPSA IVD kit leverages Cleveland Diagnostics’ IsoClear platform. This proprietary technology investigates protein biomarkers at a structural level in the blood to provide clinically relevant insights into disease state.

Cleveland Diagnostics has offered IsoPSA as a Laboratory-Developed Test (LDT) since 2020, and Medicare and a growing number of commercial payors now cover the test. IsoPSA is included in leading clinical practice guidelines, including the National Comprehensive Cancer Network (NCCN) Prostate Cancer Early Detection Guideline (2025) and the Early Detection of Prostate Cancer: American Urology Association/Society of Urologic Oncology Guideline (2023).

(Press release, Cleveland Diagnostics, DEC 1, 2025, View Source;-Cleveland-Diagnostics-Novel-Blood-Based-Prostate-Cancer-Test [SID1234661034])

Flatiron Health announces research to be presented at the 2025 San Antonio Breast Cancer Symposium

On December 1, 2025 Flatiron Health reported its presence at the San Antonio Breast Cancer Symposium (SABCS) happening from December 9-12, 2025, in San Antonio, Texas. Flatiron’s real-world data and research capabilities are featured across multiple acceptances, including three spotlight presentations and four poster presentations that leverage the breadth of Flatiron’s breast cancer solutions."Breast cancer is the most common cancer in women worldwide, and every patient’s journey raises critical questions—about treatment effectiveness, biomarker-driven approaches, clinical outcomes, and real-world access," said Emily Castellanos, MD, MPH, Senior Medical Director and Head of Research Oncology at Flatiron Health. "At Flatiron, we’ve built a comprehensive, integrated ecosystem of breast cancer solutions that serve every stage of the oncology development life cycle and our research at SABCS demonstrates that when you have the right data infrastructure, analytics, and clinical expertise working together, you can answer virtually any question about breast cancer care and outcomes."

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Research highlights include:

A Spotlight poster presentation leveraging the Flatiron Health–Caris Life Sciences Clinical-Molecular Database, the largest and most robust multimodal dataset of its kind, to identify key genetic alterations and expression changes linked to CDK4/6i treatment resistance.
A Spotlight poster presentation utilizing large language models to explore the real-world use of GLP-1 medications among breast cancer patients and their potential impact on treatment outcomes.
Multiple posters using Flatiron’s Panoramic breast cancer dataset to answer critical research questions on treatment patterns and the effectiveness of novel treatments in improving overall survival and progression-free survival in large, representative patient cohorts.
Learn more about our presence on Flatiron.com and follow Flatiron Health on X and LinkedIn for more updates from #SABCS25.

Abstracts and Poster Presentations
Personalized acquired CDK4/6i resistance: Associations with baseline characteristics like obesity in real-world (RW) clinical-multiomics data
Spotlight Poster Presentation
Kristin M. Zimmerman Savill, Lilia Bouzit, Noelle Liao, Cheryl Cho-Phan, Simon Papillon-Cavanagh
Author Affiliations: Caris Life Sciences, Flatiron Health
Presentation Number: PD3-02
Poster Spotlight 3: Emerging Paradigms of CDK Inhibitor and Antibody Drug Conjugate Resistance in Metastatic Breast Cancer
Presentation Date/Time: Wednesday, December 10, 2025, 7:33 AM – 7:36 AM
Location: 302 ABC

Racial/ethnic inequities in access to novel therapies and outcomes in triple negative breast cancer
Spotlight Poster Presentation
Olive M. Mbah, Gene G. Ho, Catherine Keane, Aaron Dolor, Cleo Ryals
Presentation Number: PD1-06
Poster Spotlight 1: Addressing breast cancer disparities and treatment related toxicities
Presentation Date/Time: Wednesday, December 10, 2025, 7:45 AM – 7:48 AM
Location: Hemisfair 3

Real-world glucagon-like peptide-1 use and association with clinical characteristics, social determinants, and circulating tumor DNA positivity in patients with breast cancer
Spotlight Poster Presentation
Cleo A. Ryals, Auriane Blarre, Blythe Adamson, Daniel Bower, Gene G. Ho, Olive Mbah, Selina Radlein, Erin Fidyk, Fatima Cody Stanford, Aaron B. Cohen
Author Affiliations: Massachusetts General Hospital, Flatiron Health
Presentation Number: PD8-08
Poster Spotlight 8: Beyond the Scale- Obesity and GLP-1 Therapies in Breast Cancer
Presentation Date/Time: Thursday, December 11, 2025, 8:03 AM – 8:06 AM
Location: 221 ABC

Real-world progression-free survival 2 (rwPFS2) and tumor response with CDK4/6is + aromatase inhibitor (AI) in patients (pts) with HR+/HER2– metastatic breast cancer (MBC)
Hope M. Rugo, Adam Brufsky, Rachel M. Layman, Xianchen Liu, Benjamin Li, Lynn McRoy, Aaron B. Cohen, Melissa Estevez, Paul Cottu, Marc Thill, Giuseppe Curigliano
Author Affiliations: City of Hope Comprehensive Cancer Center, UPMC Hillman Cancer Center, The University of Texas MD Anderson Cancer Center, Pfizer, Université Paris Cité, Agaplesion Markus Krankenhaus, University of Milano, European Institute of Oncology, Flatiron Health
Presentation Number: PS1-11-10
Poster Session 1: Wednesday, December 10, 2025, 12:30 PM–2:00 PM

Real-world treatment patterns and clinical outcomes in patients with emerging estrogen receptor 1 (ESR1)-mutated ER+ metastatic breast cancer in the U.S., 2018-2024
Jane Meisel, Tim Pham, Clara Chen, Ayush Kris, James Roose
Author Affiliations: Emory Winship Cancer Institute, AstraZeneca, Flatiron Health
Presentation Number: PS2-02-04
Poster Session 2: Wednesday, December 10, 2025, 5:00 PM – 6:30 PM

Real-world treatment patterns in 1954 US patients with HER2-negative early breast cancer and germline BRCA mutations (2021–2025)
Sagar Sardesai, Meng Ru, Xinran Ma, Catherine Keane, Jingru Wang, Miguel Miranda, Xiaoqing Xu, Claudine Isaacs
Author Affiliations: The Ohio State University Comprehensive Cancer Center, Lombardi Comprehensive Cancer Center, AstraZeneca, Flatiron Health
Presentation Number: PS2-02-03
Poster Session 2: Wednesday, December 10, 2025, 5:00 PM – 6:30 PM

Real-world overall survival with palbociclib plus an aromatase inhibitor (AI) in patients with HR+/HER2− metastatic breast cancer (MBC) who are overweight/obese
Adam Brufsky, Neil M. Iyengar, Xianchen Liu, Benjamin Li, Doris Makari, Lynn McRoy, Aaron B. Cohen, Melissa Estevez, Vandana G. Abramson, Rachel M. Layman, Giuseppe Curigliano
Author Affiliations: UPMC Hillman Cancer Center, Emory University School of Medicine, Pfizer, Vanderbilt University Medical Center, The University of Texas MD Anderson Cancer Center, University of Milano, European Institute of Oncology, Flatiron Health
Presentation Number: PS2-04-12
Poster Session 2: Wednesday, December 10, 2025, 5:00 PM – 6:30 PM

(Press release, Flatiron Health, DEC 1, 2025, View Source [SID1234661033])

Janux Announces Encouraging Efficacy and Safety Profile from Ongoing Phase 1 Clinical Trial for JANX007 in mCRPC

On December 1, 2025 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, reported positive updated interim data for its JANX007, a PSMA-directed TRACTr, Phase 1 clinical program in patients with mCRPC. Janux will host a virtual event on Monday, December 1, 2025, at 4:30 PM ET.

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"We are pleased JANX007 achieved durable responses with a manageable safety profile that compares favorably to both approved and investigational therapies in mCRPC. Additionally, we found that the ability to transition patients to Q2W dosing may provide meaningful convenience advantages," said David Campbell, Ph.D., President and CEO, Janux Therapeutics. "We look forward to evaluating the potential for JANX007 in earlier-line mCRPC, where improved tolerability and durability could have an even greater impact."

"The early data with JANX007 are highly encouraging. I am deeply committed to this program and inspired by its potential to transform care for mCRPC patients, especially as its potential in earlier-line mCRPC treatment is explored," said Dr. Eleni Efstathiou, Section Chief, Genitourinary Medical Oncology, Houston Methodist Cancer Center and investigator on the trial.

Updated Phase 1 interim clinical data for PSMA-TRACTr JANX007 in mCRPC

As of the October 15, 2025 data cutoff, a total of 109 patients have been treated across the Phase 1a dose escalation and Phase 1b expansion trials of JANX007. The patients enrolled in the Phase 1a trial were heavily pre-treated with a median of four prior lines of therapy. The patients enrolled in the Phase 1b expansion trial were taxane-naïve mCRPC.

Patients from the Phase 1 trials demonstrated high prostate-specific antigen (PSA) response rates and deep PSA declines. Anti-tumor activity was observed with confirmed and unconfirmed partial responses in 30% (8/27) of RECIST-evaluable patients.

Encouraging durability was observed in both the QW and every two week (Q2W) expansions with rPFS ranging from 7.9 to 8.9 months and the rPFS of the Q2W expansion group comparing favorably to the QW expansion group.

Preliminary Phase 1b data in taxane-naïve patients demonstrated rapid and deep PSA reductions with primarily grade 1 CRS. Additionally, tumor burden analysis suggests potential for improved rPFS in JANX007 treated earlier line patients.

JANX007 demonstrated a manageable safety profile with cytokine release syndrome (CRS) primarily limited to cycle 1 and grades 1 and 2. Additionally, a CRS mitigation strategy was identified that maintains the grade 1 and 2 CRS profile.

"These findings with JANX007 demonstrate strong efficacy and a CRS safety profile that is predictable and manageable, enabling clinicians to confidently anticipate and address CRS promptly and effectively during early treatment cycles," said Dr. Benjamin Garmezy, Associate Director, Genitourinary Cancer Research; Executive Co-Chair, Genitourinary Cancer Research Executive Committee, Sarah Cannon Research Institute (SCRI) and investigator on the trial.

Janux is advancing JANX007 with a focus on monotherapy and darolutamide combinations in taxane-naïve mCRPC patients. This is the largest and growing mCRPC setting due to increased use of ARPIs in HSPC. Janux also plans to evaluate JANX007 in PARP inhibitor refractory patients as a potential path to an expedited approval.

Webcast Information

Janux will host a live webcast today at 4:30 PM ET. A live analyst question and answer session will follow the formal presentation. To register for the event, please click here.

To access the live webcast, please visit the Investors section of the Company’s website. A replay of the webcast presentation will be available on the Company’s website at View Source for at least 30 days.

Janux’s TRACTr, TRACIr and ARM Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials. Janux is also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development.

(Press release, Janux Therapeutics, DEC 1, 2025, View Source [SID1234661032])

IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types

On December 1, 2025 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE034, a potential first-in-class bispecific B7H3/PTK7 TOP1 antibody-drug conjugate (ADC). IDEAYA expects to begin enrolling the study in Q1 2026, initially evaluating patients with solid tumors known to express B7H3 and PTK7, including lung, colorectal, head and neck and ovarian/gynecological cancers. Based on the Human Protein Atlas database, B7H3/PTK7 has been reported to be co-expressed in lung, colorectal, and head and neck cancers at approximately 30%, 46% and 27%, respectively.

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"IND clearance for IDE034 is an important step in expanding our potential first-in-class TOP1 ADC clinical pipeline into bispecific, precision-guided approaches," said Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer of IDEAYA Biosciences. "IDE034 has demonstrated robust antitumor activity and selective targeting of B7H3- and PTK7-expressing solid tumor models. The high prevalence of B7H3/PTK7 co-expression in solid tumors such as lung, colorectal, and head and neck cancers underscores its broad indication potential."

"We are excited to advance our differentiated clinical strategy with now three potentially first-in-class clinical-stage programs focused on enhancing the efficacy of TOP1 ADCs through the PARG DDR combination mechanism. We believe this approach addresses a key unmet need by improving the durability of response to TOP1 payload-based ADC therapies. We are targeting to share additional preclinical data to support the PARG and TOP1 ADC combination rationale at a major medical conference in H1 2026," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

Preclinical studies have demonstrated strong anti-tumor activity in B7H3/PTK7-positive tumor models, including deep and durable tumor regressions with IDE034 monotherapy, supporting advancement into clinical development. This co-expression pattern supports the potential for broad monotherapy activity, while the TOP1 payload provides a strong mechanistic rationale for combining IDE034 with IDEAYA’s PARG inhibitor, IDE161. TOP1 inhibition induces replication stress and DNA damage, which can increase reliance on the PARG pathway; therefore, a IDE034 and IDE161 combination approach may enhance anti-tumor activity in patients with solid tumors that co-express B7H3 and PTK7, consistent with the results that were observed preclinically with this combination.

(Press release, Ideaya Biosciences, DEC 1, 2025, View Source [SID1234661031])

Blood Cancer United Showcases Bold Research and Vision at 2025 ASH Annual Meeting

On December 1, 2025 Blood Cancer United—formerly The Leukemia & Lymphoma Society— reported it will celebrate new data presented by Blood Cancer United funded grantees at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (December 6-9, 2025).

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"We are excited to see firsthand at the ASH (Free ASH Whitepaper) Annual Meeting the scientific breakthroughs that provide life-changing benefits for more patients, helping to extend and improve their lives and move us closer to achieving durable remission for more patients with blood cancer," says Lore Gruenbaum, Ph.D., Chief Scientific Officer, Blood Cancer United.

Blood Cancer United will present findings from four sub-studies from its Beat AML Master Clinical Trial and Pediatric Acute Leukemia Master Clinical Trial (PedAL).

Data from Beat AML—the first ever collaborative precision medicine clinical trial in blood cancer—include an oral presentation of an analysis from over 2,000 venetoclax treated patients that incorporates clinical and genomic features to improve the assessment of patient prognosis, an important factor in clinical practice. A second oral presentation reports an analysis of the impact of mutations in RAS genes on the prognosis of patients who have acute myeloid leukemia (AML) with NPM1 mutations. A trial in progress poster presentation introduces a Beat AML sub-study assessing the efficacy of the combination of ficlatuzumab, a first-in-class anti-hepatocyte growth factor antibody, with azacytidine and venetoclax. The abstract from PedAL—the first integrated, global, pediatric acute leukemia master clinical trial—identifies opportunities to optimize treatments for children with AML.

On the heels of the FDA’s approval of ziftomenib for the treatment of adults with an advanced form of AML with a mutation in a gene called NPM1, we will see new data on the use of this and other menin inhibitors at ASH (Free ASH Whitepaper). The early drug discovery work that led to the development of ziftomenib was supported through the Therapy Acceleration Program (TAP). At the meeting, two oral presentations on combination studies of ziftomenib, venetoclax and azacitidine in newly diagnosed and relapsed/refractory AML will be presented.

Fifteen current and former TAP biotech partners will present more than 50 abstracts—including eight oral presentations—showcasing promising clinical results across blood cancers, including AML, myelodysplastic syndrome, large granular lymphocytic leukemia, myelofibrosis, blastic plasmacytoid dendritic cell neoplasm, T-cell lymphoma and more.

Studies funded through Blood Cancer United’s Academic Research Grant Program, Equity in Access Research Program, Influential Medicine Providing Access to Clinical Trials and Student Mentorship and Research Training (SMART) Program will be presented throughout the meeting.

This research evaluates opportunities to improve cancer care quality for patients with all types of blood cancer, including the impact of travel and insurance type on access to care.

Blood Cancer United leaders and experts are available to discuss Blood Cancer United supported studies and provide comments on other data at the meeting.

Lore Gruenbaum, Ph.D., Chief Scientific Officer
E. Anders Kolb, M.D., Chief Executive Officer
Gwen Nichols, M.D., Chief Medical Officer
Ashley Yocum, Ph.D., Master Trial Lead
Further information on Blood Cancer United’s research portfolio is available at bloodcancerunited.org/research.

Additional details on key presentations from Blood Cancer United funded researchers at ASH (Free ASH Whitepaper) are available below. The full ASH (Free ASH Whitepaper) Annual Meeting 2025 abstracts are available here.

Title

Date/Time

Presentation Type

Abstract ID

Beat AML

Prognostic risk integration for survival modeling (PRISM) in newly diagnosed acute myeloid leukemia treated with venetoclax: a multinational retrospective cohort study

December 7
10 to 10:15 a.m. ET

Oral Presentation

453

Phase 1b safety run-in study followed by Phase 2 study of ficlatuzumab, azacitidine and venetoclax in untreated Acute Myeloid Leukemia patients aged ≥ 60 years old

December 7
6 to 8 p.m. ET

Poster Presentation

3432

RAS mutations negate the favorable impact of NPM1 in older patients with newly diagnosed Acute Myeloid Leukemia treated with ven/HMA

December 8
5:30 to 5:45 p.m. ET

Oral Presentation

995

PedAL

ITCC-101/APAL2020D: A randomized Phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamycin with or without venetoclax in children with relapsed Acute Myeloid Leukemia

December 6
5:30 to 7:30 p.m. ET

Poster Presentation

1656

Therapy Acceleration Program

Efficacy, molecular and translational analysis of TP53-mutated HR-MDS with bexmarilimab and azacitidine: Updated results from the bexmab Phase 1/2 study

December 6
2:15 to 2:30 p.m. ET

Oral Presentation

236

γ9δ2 T-cell (γ9δ2TC) activation with ICT01 and azacitidine-venetoclax (Aza-Ven) induces high rates of remission and overall survival in patients with newly diagnosed (ND) acute myeloid leukemia (AML): Results from the phase 1/2 study eviction

December 7

5:15 to 5:30 p.m. ET

Oral Presentation

652

Initial clinical data from the phase 1 study of DR-01, a non-fucosylated anti-CD94 antibody in patients with large granular lymphocytic leukemia

December 8

11 to 11:15 a.m. ET

Oral Presentation

777

Academic Research Grants

Circulating tumor cells (CTCs) for dynamic risk assessment of patients (Pts) with smoldering multiple myeloma (SMM)

December 7

9:30 to 9:45 a.m. ET

Oral Presentation

493

Rituximab and epcoritamab as first-line therapy for patients with high-tumor burden follicular lymphoma: Results of a multicenter phase II trial

December 7

9:45 to 10 a.m. ET

Oral Presentation

464

Humanized CD19 chimeric antigen receptor (CAR) T-cell therapy for high-risk and post-CAR relapse of B-cell acute lymphoblastic leukemia

December 7

5:15 to 5:30 p.m. ET

Oral Presentation

646

Interim Results of the CMML intercept study: A prospective observational study to evaluate the role of acute inflammation in CMML disease progression

December 8

10:45 to 11 a.m. ET

Oral Presentation

788

Evidence for pre-existing myeloma cells with a gene expression pattern associated with resistance to BCMA CAR T cells.

December 8

5:30 to 5:45 p.m. ET

Oral Presentation

1031

Novel Targets and Therapeutics for Optimizing HSCT and Cell Therapy

December 9

9:45 to 11:15 a.m. ET

Presidential Symposium

N/A

Equity in Access

Travel time and insurance status as determinants of specialized leukemia care access in adolescents and young adult (AYA) patients with acute lymphoblastic leukemia (ALL)

December 6
2 p.m. ET

Oral Presentation

283

Medicaid versus commercial insurance: Association with quality of end-of-life care among patients with blood cancers

December 6
2:30 p.m. ET

Oral Presentation

285

Real-world rates of tyrosine kinase inhibitor prescription approval, fill, and adherence and associated factors in a national sample of patients with chronic myeloid leukemia

December 6
5:30 p.m. ET

Poster Presentation

2651

Strengthening the referral pathway: Community oncology clinician perspectives on referring to academic cancer centers

December 8
11:30 a.m. ET

Oral Presentation

833

Characterizing Hodgkin lymphoma survivors’ shared decision making across the care continuum

December 8
6:00 p.m. ET

Poster Presentation

6424

Health Services

The impact of a clinical trial communication training workshop on hematology-oncology Fellows’ knowledge, attitudes and behaviors: A mixed-methods evaluation

December 8
11:45 a.m. ET

Oral Presentation

834

SMART

CBFA2T3::GLIS2 directly represses differentiation and is required for AMKL disease maintenance

December 6

5:30 to 7:30 p.m. ET

Poster Presentation

1473

(Press release, The Leukemia & Lymphoma Society, DEC 1, 2025, View Source [SID1234661030])