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])

On December 1, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the publication of a peer-reviewed article in Nature communications, reporting data from the REACtiVe-2 clinical trial. REACtiVe-2 is a Phase 1 dose-escalation study evaluating the safety, tolerability and immunological effects of mitazalimab in combination with the dendritic cell-based vaccine MesoPher, developed by Amphera, in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) following standard of care chemotherapy. The study, conducted at Erasmus Medical Center in Rotterdam, underscores mitazalimab’s ability to activate anti-tumor immunity and support its proposed mode of action, including a reduction of tumor fibrosis, as well as increased T-cell infiltration and activation in the tumor.

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Key findings:

The combination therapy significantly decreased intratumoral collagen content, likely through mitazalimab-mediated macrophage activation and stromal degradation.
Treated tumors showed a clear rise in intratumoral T cells, indicating improved recruitment and immune access to the tumor.
The treatment activated central memory CD4+ T cells and triggered immune pathways related to antigen presentation.
Patients with stable disease after prior chemotherapy achieved a median OS of 12.1 months and a 1-year survival rate of 50%.
"These compelling translational data provide further support for the therapeutic potential of mitazalimab in reshaping the immunosuppressive microenvironment characteristic of pancreatic cancer," said Søren Bregenholt, CEO of Alligator Bioscience. "Furthermore, the data validates the immunological basis behind mitazalimab’s mechanism of action, thereby reinforcing it’s rational in mPDAC and other solid tumors, in combination with other treatment modalities.
The REACtiVe-2 study has been a part of Alligator’s broader clinical strategy to establish mitazalimab as a immunotherapy in hard-to-treat cancers such as mPDAC. The findings further highlight the synergistic potential of mitazalimab when combined with vaccines and chemotherapy.

(Press release, Alligator Bioscience, DEC 1, 2025, View Source [SID1234661015])

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])

On November 28, 2025 Pasithea Therapeutics Corp. ("Pasithea" or the "Company") (Nasdaq: KTTA; KTTAW), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), reported the pricing of a public offering of 80,000,000 shares of the Company’s common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.75 per share of common stock (or per pre-funded warrant in lieu thereof). The public offering was led by healthcare-dedicated investors, including Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners, and Squadron Capital Management.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The closing of the offering is expected to occur on or about December 1, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from the offering are expected to be approximately $60 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes. The Company’s cash position following the closing will extend its cash runway through at least the first half of 2028. Such corporate purposes include, without limitation, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to the Company’s technologies, licensing activities related to its current and future product candidates, and to the development of emerging technologies, investing in or acquiring companies that are developing emerging technologies, licensing activities, or the acquisition of other businesses and working capital.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-291611) originally filed with the Securities and Exchange Commission ("SEC") on November 18, 2025, as amended on November 26, 2025, and declared effective on November 28, 2025. The offering is being made only by means of a prospectus, which is part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. When available, electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Pasithea Therapeutics, NOV 28, 2025, View Source [SID1234660995])

On November 28, 2025 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in the 8th Annual Evercore Healthcare Conference, which is taking place from December 2 – 4, 2025. The fireside chat is scheduled to take place on Tuesday, December 2, 2025, at 12:30 PM ET.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the fireside chat will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

(Press release, TG Therapeutics, NOV 28, 2025, View Source [SID1234660996])