On August 6, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported the presentation of encouraging preclinical data for its lead drug candidate, Annamycin, also known by its non-proprietary name of naxtarubicin, which demonstrated significant efficacy against various primary and metastatic liver cancers, including hepatocellular carcinoma (HCC), colorectal liver metastases, and pancreatic ductal adenocarcinoma (PDAC) liver metastases (Press release, Moleculin, AUG 6, 2025, View Source [SID1234654867]). This is believed to be the result of targeted accumulation in the liver and other organs.

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These findings were highlighted in a poster titled "Liposomal Annamycin (L-ANN) Efficacy Against Primary and Metastatic Liver Cancers," presented by Dr. Waldemar Priebe, Lead Author and Chairman of the Scientific Advisory Board at Moleculin at the recently held Shelby-Lavine Pancreatic Cancer Symposium at MD Anderson Cancer Center.

Key Highlights

Targeted Accumulation in Organs: The preclinical studies confirmed that Annamycin exhibits distinct organotropic properties, leading to significantly higher concentrations in the liver, spleen, lungs, and pancreas when compared to doxorubicin (DOX). This targeted accumulation is critical for effectively treating liver-localized tumors.
Efficacy in Orthotopic Hepatocellular Carcinoma (HCC) Models: Annamycin demonstrated excellent anti-tumor activity in orthotopic HCC models (Hepa 1-6 Luc), showing a marked reduction in tumor progression and improved survival rates in treated animals compared to vehicle controls.
Potent Impact on Colorectal Liver Metastasis: In an experimental liver metastatic model of colorectal carcinoma (CT26 Luc), Annamycin significantly inhibited metastatic growth and extended survival, highlighting its potential for addressing liver metastases in colon cancer that affects close to 50% of patients.
Promising Results in Pancreatic Cancer Liver Metastasis: Annamycin also showed compelling efficacy in liver-implanted human pancreatic ductal adenocarcinoma (MIA PaCa-2), leading to inhibition of tumor growth, suggesting its potential role in managing advanced pancreatic cancer with liver involvement.
Favorable Safety Profile: Consistent with previous preclinical and clinical findings, Annamycin continued to show low or no cardiotoxicity, a significant advantage over traditional anthracyclines like doxorubicin, which are often limited by dose-dependent cardiac side effects. This safety profile was previously observed in clinical trials, where 32 out of 42 subjects reviewed received more than the FDA-established lifetime maximum allowable level of anthracycline without evidence of cardiotoxicity.
"We are incredibly encouraged by these preclinical results, which further validate Annamycin’s potential as a powerful and differentiated therapeutic agent for liver cancers," said Dr. Priebe. "The ability of Annamycin to concentrate effectively in the liver, combined with its demonstrated efficacy across multiple aggressive liver cancer models and its favorable cardiotoxicity profile, positions it as a highly promising candidate for patients facing these devastating diseases. We believe these data provide a strong foundation for advancing Annamycin in clinical development for these indications, offering new hope where treatment options are often limited."

Walter Klemp, Chairman and CEO of Moleculin, added, "We continue to be strongly encouraged by the potential of Annamycin. Beyond our preliminary programs in AML and soft tissue sarcoma lung metastases (STS lung mets), we continue to advance and develop Annamycin through multiple investigator-initiated studies to further unlock its potential as a treatment option for many other types of cancers. We believe this preclinical data highlights that potential and provides additional validation of its unique pharmacological profile and importantly showcases the opportunity for its use across a wide range of cancers."

Moleculin’s novel drug candidate is being positioned to become the first ever non-cardiotoxic anthracycline to be approved and is currently being developed for the treatment of AML and STS lung mets. For more information, please visit moleculin.com.

On August 6, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported its financial results for the fourth quarter ending June 30, 2025 (Press release, Bio-Techne, AUG 6, 2025, View Source [SID1234654886]).

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Fourth Quarter FY2025 Highlights

Fourth quarter organic revenue increased by 3% (4% reported) to $317.0 million. Full year organic revenue increased 5% (5% reported) to $1.2 billion.
GAAP earnings per share (EPS) was $ (0.11) versus $0.25 one year ago. Delivered adjusted EPS of $0.53 compared to $0.49 one year ago. Full year GAAP EPS was $0.46 versus $1.05 one year ago. Full year adjusted EPS was $1.92 versus $1.77 one year ago.
Strong performance in our proteomic analytic and cell therapy growth pillars drove 4% organic growth (6% reported) in the Protein Sciences segment for the quarter, and 5% organic and reported growth for the full year.
Announced divestiture of the Exosome Diagnostics business including the ExoDx Prostate test (EPI) as the Company emphasizes investment and commercial priorities on non-CLIA based product lines in their growth pillars.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted diluted EPS, adjusted net earnings, adjusted gross margin, adjusted operating income, adjusted tax rate, organic revenue, adjusted operating margin, earnings before interest, taxes, depreciation, and amortization (EBITDA), and adjusted EBITDA are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"Bio-Techne delivered a solid fourth quarter that was in-line with our expectations, despite ongoing market uncertainty," said Kim Kelderman, President and Chief Executive Officer of Bio-Techne. "We achieved strong performance in our cell therapy and protein analysis instrumentation growth pillars, supported by a resilient pharma market. Our fiscal year 2025 results reflect the outstanding execution by our team and the meaningful impact our innovative solutions continue to deliver for customers, which include accelerating development timelines and driving scientific breakthroughs."

Kelderman added, "Last night, we announced the divestiture of our Exosome Diagnostics business. This strategic decision will immediately strengthen our profitability and allow us to increase our focus on high-growth areas, particularly tools for research and precision diagnostics."

Kelderman concluded, "While market uncertainties persist, I have full confidence in our team’s ability to navigate the evolving landscape and continue delivering meaningful value to all our stakeholders."

Bio-Techne will host an earnings conference call today, August 6, 2025, at 8:00 a.m. CDT. To listen, please dial 1-800-274-8461 or 1-203-518-9814 (for international callers), and reference conference ID TECHQ4. The earnings call can also be accessed via webcast through the following link View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512- 2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 11159590. The replay will be available from 11:00 a.m. CDT on Wednesday, August 6, 2025, until 11:00 p.m. CDT on Saturday, September 6, 2025.

Fourth Quarter Fiscal 2025

Revenue

Net sales for the fourth quarter increased 4% to $317.0 million. Organic revenue increased 3% compared to the prior year. Foreign currency exchange had a favorable impact of 2%, and non-recurring prior year revenue from a business held-for-sale had an unfavorable impact of 1%.

GAAP Earnings Results

GAAP EPS was ($0.11) per diluted share, versus $0.25 in the same quarter last year. GAAP operating income for the fourth quarter of fiscal 2025 decreased 152% to ($23.9) million, compared to $45.8 million in the fourth quarter of fiscal 2024. GAAP operating margin was (7.5)%, compared to 15.0% in the fourth quarter of fiscal 2024. Current quarter GAAP operating margin was unfavorably impacted by impairment of the Exosome Diagnostics business.

Non-GAAP Earnings Results

Adjusted EPS increased to $0.53 per diluted share compared to $0.49 in the same quarter last year. Adjusted operating income of $101.3 million in the fourth quarter of fiscal 2025 remained relatively consistent with fourth quarter of fiscal 2024 adjusted operating income of $101.8 million. Adjusted operating margin was 32.0% for the fourth quarter of fiscal 2025 compared to 33.5% in the fourth quarter of fiscal 2024. Adjusted operating margin was impacted by unfavorable product mix, especially within the Diagnostic Solutions segment.

Full Year Fiscal 2025

Revenue

Net sales for the full year fiscal 2025 increased 5% to $1.2 billion. Organic revenue increased 5%. Foreign currency exchange and a business held-for-sale did not have a material impact.

GAAP Earnings Results

GAAP EPS was $0.46 per diluted share, compared to $1.05 last fiscal year. GAAP operating income for full year fiscal 2025 decreased 51% to $102.3 million, compared to $206.7 million in the full year fiscal 2024. GAAP operating margin was 8.4%, compared to 17.8% in the full year fiscal 2024. GAAP operating margin was unfavorably impacted by impairment of assets held-for-sale, restructuring and restructuring-related costs, and a non-recurring arbitration award.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.92 per diluted share, compared to $1.77 last fiscal year. Adjusted operating income for fiscal 2025 increased 4% to $383.6 million, compared to $370.2 million for fiscal 2024. Adjusted operating margin for full year fiscal 2025 decreased to 31.6%, compared to 32.1% in full year fiscal 2024. Adjusted operating margin was impacted by reinstatement of incentive compensation accruals as well as unfavorable product mix.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biopharma and academic research communities. Additionally, the segment provides multiple platforms useful in various areas of protein analysis. In fiscal year 2024, a business within the Protein Sciences Segment met the criteria of held-for-sale; the held-for-sale business has been excluded from the segment’s operating results. Protein Sciences segment’s fourth quarter fiscal 2025 net sales were $226.5 million, an increase of 6% from $214.0 million for the fourth quarter of fiscal 2024. Organic revenue growth was 4% for the fourth quarter of fiscal 2025, with foreign currency exchange having a favorable impact of 2%. The Protein Sciences segment’s operating margin increased to 43.6% in the fourth quarter of fiscal 2025 compared to 43.0% in the fourth quarter of fiscal 2024. The segment’s operating margin increased primarily due to favorable volume leverage and ongoing profitability initiatives.

Protein Sciences segment’s full year fiscal 2025 net sales were $870.2 million, an increase of 5% from $830.9 million for full year fiscal 2024. Organic revenue for the segment increased 5% for the fiscal year, with foreign currency exchange and a business held-for-sale not having a material impact on revenue. Protein Sciences segment’s operating margin was 42.6% in fiscal 2025 compared to 42.7% in fiscal 2024.

Diagnostics and Spatial Biology Segment

The Company’s Diagnostics and Spatial Biology segment develops and provides spatial biology products, carrier screening and oncology kits, as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Spatial Biology segment also provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Exosome Diagnostics business met the held-for-sale criteria at June 30, 2025 and incurred an impairment loss of $83.1 million during the quarter. The Diagnostics and Spatial Biology segment’s fourth quarter fiscal 2025 net sales were $89.7 million, a decrease of 1% from $90.7 million for the fourth quarter of fiscal 2024. Organic revenue decreased 1% for the fourth quarter of fiscal 2025, with foreign exchange not having a material impact. The Diagnostics and Spatial Biology segment’s operating margin of 6.0% in the fourth quarter of fiscal 2025 compared to 12.5% in the fourth quarter of fiscal 2024. The segment’s operating margin was impacted by unfavorable product mix.

The Diagnostics and Spatial Biology segment’s full year fiscal 2025 net sales were $346.3 million, an increase of 6% from $326.4 million for full year fiscal 2024. Organic growth for the segment was 6% with foreign currency exchange not having a material impact on revenue growth. The Diagnostics and Spatial Biology segment’s operating margin was 6.2% in fiscal 2025 compared to 7.5% in fiscal 2024. The segment’s operating margin was impacted by the reinstatement of incentive compensation accruals as well as unfavorable product mix.

On August 6, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that the strong clinical successes in oncology of its drug Ampligen will be presented in four separate aspects at the upcoming 5th Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care in Warsaw, Poland (Press release, AIM ImmunoTech, AUG 6, 2025, View Source [SID1234654852]). This will include a presentation by AIM regarding its ongoing lead clinical program in late-stage pancreatic cancer; a presentation by Pawel Kalinski, MD, PhD, a world-renowned research oncologist and senior investigator for multiple oncology clinical studies involving Ampligen, outlining his clinical research with Ampligen in multiple other solid tumor types; a presentation of Kathleen Kokolus, PhD, a senior scientist in Dr. Kalinski’ laboratory, who will discuss cellular and molecular mechanisms of action of Ampligen; and finally a presentation and abstract on positive data strongly suggesting Ampligen’s potential as a therapy in the treatment of endometriosis.

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Dr. Kalinski observed, "This important global symposium is being held September 3-5, 2025. It will be attended by many of the top oncology researchers, government health officials and major pharma companies of Europe, in an effort to showcase and bring U.S.-developed, early-phase clinical trials to patients in Central and Eastern European Countries (CEEC) and to accelerate the development and clinical testing of such treatments to benefit patients in the United States and worldwide."

Oncology

An AIM representative will present data from AIM’s pancreatic cancer Early Access Program and advances in the Phase 2 pancreatic cancer clinical trial currently underway at Erasmus Medical Center in the Netherlands. Among the expected highlights will be recent data from the DURIPANC study, an ongoing Phase 2 clinical study evaluating the combination therapy of Ampligen and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor durvalumab in the treatment of late-stage metastatic pancreatic cancer patients. Following FOLFIRINOX, maintenance or second-line immunotherapies have historically shown limited survival benefit in comparison trials. Preliminary data from DURIPANC suggests that Ampligen may prove to change that equation for the better.

Last week, the Company released a DURIPANC Mid-Year Interim Clinical Progress Update showing that the therapy is, thus far, well-tolerated with positive preliminary survival data, especially given the historical difficulty of improving outcomes in this setting. Compared to historical data, the DURIPANC study mid-year report shows continuing promising early signs of both no significant toxicity and superior PFS and OS:

No significant toxicity, an encouraging safety profile for a post-chemo setting;
~21% of patients have PFS >6 months (3/14), with an additional 21% not yet progressed; and
OS >6 months in the majority (64%) of eligible patients-better than expected in this setting.
Patient-reported outcomes indicated a consistently high level of quality of life throughout the treatment period. This is particularly notable given that patients with advanced disease typically experience substantial symptom burden and functional decline. In the context of a Phase 1/2 study, where the primary objectives often include safety, tolerability and preliminary signals of efficacy, the preservation or improvement of quality of life serves as a critical complementary endpoint.

Dr. Kalinski’s presentation will highlight Ampligen’s overall oncological advances and successes in clinical trials for multiple other solid tumors, including late-stage recurrent ovarian, Stage-four triple-negative breast and late-stage metastatic colorectal cancer.

Dr. Kokolus will discuss cellular and molecular mechanisms of the Ampligen-based chemokine-modulatory regimen’s activity in enhancing the effectiveness of PD1 blockade in "cold" tumors

All of the late-stage cancers being challenged by Ampligen therapy whose results will be discussed are lethal malignancies and constitute serious and unmet global health care issues.

Endometriosis

The endometriosis abstract and presentation will be based on an analysis of data from AIM’s Phase 2 and Phase 3 clinical trials of Ampligen for the treatment of Chronic Fatigue Syndrome ("CFS"), which showed that a large percentage of female participants had significant comorbidity with endometriosis. Approximately 80% of subjects experienced improvement in symptoms in the analyzed data.

Endometriosis is a common chronic and debilitating inflammatory disease affecting approximately 10% (190 million) of women of reproductive age globally and is associated with a risk of ovarian cancer. The hallmark of endometriosis is the presence of endometrium-like tissue on the peritoneum and ovaries. Growth of ectopic tissue in endometriosis patients leads to chronic pelvic pain; painful menstrual cramps; long-term pain in the lower back and pelvis; pain during intercourse; and infertility. Available radical treatments – such as the removal of the fallopian tubes and ovaries – can be difficult to justify in this group of young, prime-of-life patients, which highlights the need for new treatments.

Read more on the link between CFS and endometriosis: "Endometriosis as a Comorbid Condition in Chronic Fatigue Syndrome (CFS): Secondary Analysis of Data From a CFS Case-Control Study"

Read more on the link between endometriosis and ovarian cancer: "Complement Pathway Is Frequently Altered in Endometriosis and Endometriosis-Associated Ovarian Cancer"

AIM believes that the data demonstrates a compelling rationale for further optimizing a treatment protocol of IV Ampligen in patients with endometriosis.

On August 6, 2025 NKGen Biotech, Inc. (OTC: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer ("NK") cell therapeutics, reported that Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen, will present at the 13th Annual Immuno-Oncology Summit (the "Summit") to be held in Philadelphia, PA, from August 11 – 13, 2025 (Press release, NKMax America, AUG 6, 2025, View Source [SID1234654868]).

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The Summit is a leading global event in cancer immunotherapy. Organized by Cambridge Healthtech Institute, the summit brings together top experts from industry and academia to explore the latest advances in cell therapies, innate immunity, bispecifics, and translational strategies. With multiple scientific tracks, high-impact presentations, and collaborative discussions, it serves as a premier forum for driving innovation and progress in the immuno-oncology field.

Presentation Details:

Title: Allogeneic Enhanced Natural Killer Cells without Lymphodepletion in Solid Tumors

Conference Track: Innate Immunity

Date and Time: Wednesday, August 13, 2025; 2:50 PM ET

Dr. Song’s presentation will focus on the pivotal role of natural killer (NK) cells as primary effector cells in the innate immune response against cancer. Traditional allogeneic donor-derived therapies often require lymphodepletion to prevent immunologic rejection, a process that can compromise combination strategies aimed at enhancing T cell activity. Dr. Song will present scientific data and early clinical findings on NKGen’s allogeneic NK cell therapy, SNK02, which is being evaluated in solid tumors without the need for lymphodepletion.

Previously disclosed Phase 1 data for SNK02 in solid tumors, which may not be included in this presentation, is available on the Scientific Publications page of the NKGen website under the "SNK02 Allogeneic" section.

On August 6, 2025 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its Birelentinib (DZD8586) for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor (Press release, Dizal Pharma, AUG 6, 2025, View Source [SID1234654887]).

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Patients with CLL/SLL treated with a BTK inhibitor or a BCL-2 inhibitor often relapse or progress due to two major resistance mechanisms: BTK C481X mutations and BTK-independent activation of BCR signaling pathway. No targeted therapy currently addresses both mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging anti-tumor activity in early CLL/SLL clinical studies, mutation-mediated resistance has already been reported, and degrader-associated toxicities may limit their long-term clinical application.

Birelentinib is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration. It has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting both BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-cell non-Hodgkin lymphomas (B-NHLs).

The Fast Track Designation is supported by data from a pooled analysis of two phase I/II studies of birelentinib in CLL/SLL patients previously treated with covalent/non-covalent BTK inhibitors and BTK degraders. The results were presented at 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress and featured in oral presentations at both the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 18th International Conference on Malignant Lymphoma (ICML).

Birelentinib demonstrated significant anti-tumor efficacy in heavily pretreated CLL/SLL patients with an objective response rate (ORR) of 84.2%, with a good safety profile. Tumor responses were observed irrespective of prior treatment with covalent/non-covalent BTK inhibitors, BTK degraders, or BCL-2 inhibitors, including in patients harboring classic BTK resistance mutations (C481X) as well as other BTK mutations, such as kinase-dead mutations. Responses were durable, with an estimated 9-month duration of response (DOR) rate of 83.3%.

"The granting of Fast Track Designation underscores the U.S. FDA’s recognition of birelentinib’s potential to address an unmet medical need in patients with CLL/SLL," said Dr. Xiaolin Zhang, CEO of Dizal. "We look forward to working closely with the FDA to accelerate the global clinical development of birelentinib and bring this treatment option to patients as quickly as possible."

Fast Track Designation is an FDA program designed to facilitate the development and expedite the review of drugs for serious conditions that address unmet medical needs. The designation enables for frequent FDA interactions and may allow for rolling revie, priority review, or accelerated approval if criteria are met.

About Birelentinib (DZD8586)

Birelentinib is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed as a potential treatment option for B-cell non-Hodgkin lymphoma (B-NHL).

While Bruton’s Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can arise through two major mechanisms: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Currently, there is no targeted therapy available to address both resistance mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging efficacy in early clinical studies, mutation-related resistance has been reported, and degrader-related toxicities may affect long-term clinical application.

Birelentinib has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-NHLs in cell lines and in animal models. In clinical studies, birelentinib exhibits favorable PK properties, good central nervous system (CNS) permeability, complete blockade of BCR signaling, and encouraging anti-tumor efficacy with good safety and tolerability in patients with B-NHL.

In August 2025, birelentinib was granted Fast Track Designation by the U.S. FDA for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.