MAIA Biotechnology Activates and Opens Enrollment at Second U.S. Clinical Site for International Phase 2 THIO-101 Expansion Trial

On June 10, 2026 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported that it has activated the second U.S. clinical site in its Phase 2 THIO-101 expansion trial at Central Alabama Research in Homewood, Alabama. The expansion part of THIO-101 evaluates MAIA’s lead investigational therapy, ateganosine, a dual-action molecule incorporating telomere targeting and immunogenicity, as a third-line (3L) treatment for non-small cell lung cancer (NSCLC) in patients who have previously failed treatment with checkpoint inhibitors (CPIs) and chemotherapy.

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Parts A and B of the Phase 2 THIO-101 Phase 2 trial provided key inputs for MAIA’s market strategy by identifying optimal dosing for a well-defined patient population. The THIO-101 expansion trial is ongoing in Europe and Asia with 44 active sites in 6 countries along with 2 in the U.S. The additional data from the trial’s expansion may further support an accelerated approval filing with the FDA.

"Adding our second U.S. site reflects strong execution of our clinical strategy and continued momentum in the expansion of the THIO-101 trial," said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. "Broadening our site footprint enables more efficient patient enrollment as we advance the program under the FDA Fast Track designation and work toward upcoming interim data milestones."

David J. Mooney, M.D., oncology physician at Central Alabama Research and principal investigator for THIO-101 in Alabama commented, "We look forward to bringing ateganosine treatment to our cancer center. There’s a large regional patient pool across the Southeast, including underserved and rural populations, that can greatly benefit from a novel therapy in this hard-to-treat NSCLC setting with very limited treatment options."

In parallel with the Phase 2 clinical trial, MAIA is actively screening and enrolling patients in a pivotal Phase 3 clinical trial designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 patients. MAIA has received regulatory approval to screen patients in Taiwan, Turkey, select European Medicines Agency (EMA) countries, and Georgia.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

(Press release, MAIA Biotechnology, JUN 10, 2026, View Source [SID1234666556])

Aethlon Medical Announces Fiscal Year End March 31, 2026 Financial Results and Corporate Update

On June 10, 2026 Aethlon Medical, Inc. (the Company or Aethlon) (Nasdaq: AEMD), a clinical-stage medical therapeutic company focused on developing products to treat cancer and life-threatening viral infections for which there is no treatment, reported financial results for its fiscal year ended March 31, 2026, and provided an update on recent developments.

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Key Highlights

Advanced the Australian oncology study through completion of the first two cohorts and entered the third and final dosing cohort, representing a key clinical milestone toward generating data to inform future development and dosing strategy.

Recently treated the first participant in Cohort 3 at Royal North Shore Hospital in Australia. The participant completed three Hemopurifier treatments over a one-week period, marking continued enrollment momentum and execution of the study’s final treatment arm.

Advanced preclinical research evaluating Hemopurifier applications in additional disease areas, including rheumatoid arthritis and chronic kidney disease, supporting the expansion of the platform’s potential addressable market beyond oncology and infectious disease.

Continued to strengthen the intellectual property portfolio supporting the Hemopurifier platform, including the issuance of patents in the United States and Europe covering potential applications for long COVID and other coronavirus-related conditions, extending patent protection into the 2040s and enhancing long-term platform value.
"Fiscal 2026 was a year of meaningful execution for Aethlon as we advanced our Australian oncology study through the first two cohorts and recently initiated Cohort 3. Advancement into the final cohort represents an important clinical milestone as we work toward generating data that may help define the optimal treatment regimen and guide future development decisions. We also strengthened the Hemopurifier platform through expansion of our intellectual property portfolio and advancement of preclinical research supporting potential applications beyond oncology. Combined with our continued focus on managing operating expenses, these achievements position us to pursue multiple value-creating opportunities across our clinical and research programs." said James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical.

Clinical Update

Clinical Progress in Cancer Trial

Enrollment and treatment of participants in Cohort 2 of the Australian oncology trial have been completed. An independent Data Safety Monitoring Board reviewed the data, identified no safety concerns based on its review of available data, and recommended advancing to the third and final cohort. Screening is actively underway at the three investigative sites for this final cohort where 3-6 participants will be treated with 3 Hemopurifier sessions during a 1-week period. The first participant in Cohort 3 of the study has been enrolled and received three Hemopurifier treatments without any device deficiencies or immediate complications and is now in the follow-up period. Successful enrollment and treatment of the first participant in Cohort 3 maintains the study’s clinical momentum and moves the Company closer to completing enrollment and generating data from all planned dosing regimens.

Serial Extracellular Vesicle and T cell measurements on participants in cohort 2 have been measured by the central lab at the University of Sydney. Formal statistical analyses comparing the effects of the three different Hemopurifier dosing regimens on these parameters will be performed by a CRO at the completion of the trial. This nine-to-18 patient study is designed to evaluate the safety and feasibility of the Hemopurifier treatments and determine the appropriate dosing in participants with solid tumors whose disease is stable or progressing while on a treatment that includes the anti-PD-1 agents, Keytruda or Opdivo.

Other Recent Developments

During fiscal 2026, we strengthened our intellectual property portfolio through the issuance of patents in both the United States and Europe covering 2 potential applications of the Hemopurifier for coronavirus-related conditions; excessive clotting known as coagulopathy during acute COVID-19 infection and symptoms of Long COVID. These patents extend protection for certain applications of the Hemopurifier into the 2040s.

In addition, we advanced our preclinical extracellular vesicle (EV) research activities, including studies evaluating removal of EVs in plasma samples from patients with rheumatoid arthritis and chronic kidney disease. These efforts support the Company’s ongoing evaluation of the Hemopurifier’s potential applications across multiple disease categories and may create future opportunities to expand the platform into large markets characterized by significant unmet medical need.

Separately, we continued our evaluation of Hemopurifier compatibility with a simplified blood treatment system being developed by Stavro Medical. Initial testing assessing flow rates and transfer of fluid through the Hemopurifier has been completed, and future studies evaluating removal of surrogate markers for extracellular vesicles by the Hemopurifier using the system are under consideration. We believe this approach could expand potential treatment settings for the Hemopurifier in the future and may improve the scalability and accessibility of treatment if successfully developed and validated.

Subsequent to fiscal year-end, an interview published in IEEE Spectrum featuring Aethlon’s Chief Medical Officer and a physician involved in the treatment of an Ebola virus disease patient with the Hemopurifier during the 2014 outbreak highlighted the Company’s experience with Ebola treatment efforts. In connection with renewed public health interest surrounding recent Ebola outbreaks, we also confirmed the continued availability of our FDA-authorized expanded access (compassionate use) protocol and shared the protocol as well as past in vitro and in vivo data with organizations involved in global and U.S. emerging pathogen preparedness efforts, including the World Health Organization’s R&D Blueprint expert panel and the National Emerging Special Pathogen Training and Education Center.

Financial Results for the Fiscal Year Ended March 31, 2026

As of March 31, 2026, the Company had approximately $5.0 million in cash and cash equivalents, providing resources to support ongoing clinical and research activities.

Subsequent to fiscal year-end, the Company strengthened its balance sheet by raising approximately $1.85 million in net proceeds through its at-the-market program.

Consolidated operating expenses declined 21.9% year-over-year to approximately $7.3 million, reflecting continued expense discipline and operational efficiency while advancing the Company’s clinical and research priorities compared to $9.3 million for the fiscal year ended March 31, 2025. The decrease was primarily due to $1.1 million reduction in payroll and related expenses, a $500,000 reduction in general and administrative expenses and a $400,000 reduction in professional fees.

Consistent with the reduction in operating expenses, the operating loss for the fiscal year decreased to approximately $7.3 million for fiscal 2026 from $9.3 million in the prior fiscal year.

Other income was approximately $142,000 for the fiscal year ended March 31, 2026, primarily reflecting interest income earned on cash balances, compared to other expense of approximately $4 million in the prior fiscal year. The prior-year amount included approximately $4.7 million of non-cash financing-related charges.

Net loss attributable to our common stockholders was $7.2 million for the fiscal year ended March 31, 2026, compared to net loss of $13.4 million for the fiscal year ended March 31, 2025.

The consolidated balance sheets for March 31, 2026, and March 31, 2025, and the consolidated statements of operations for the fiscal years ended March 31, 2026, and 2025, are included at the end of this release.

Conference Call

Management will host a conference call today, Wednesday, June 10, 2026, at 4:30 p.m. ET to review the Company’s financial results and recent corporate developments. Following management’s formal remarks, there will be a question-and-answer session.

Interested parties can register for the conference call by navigating to View Source Please note that registered participants will receive their dial-in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:

PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741
PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through July 10, 2026. The replay can be accessed via Aethlon Medical’s website or by dialing 1-855-669-9658 (USA or Canada) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 7883435.

(Press release, Aethlon Medical, JUN 10, 2026, View Source [SID1234666541])

Kyowa Kirin to Present New Complementary Evidence Further Defining Clinical Utility of Mogamulizumab in Cutaneous T-Cell Lymphoma at 2026 WCCL

On June 10, 2026 Kyowa Kirin, Inc., a wholly owned subsidiary of Kyowa Kirin Co. Ltd (TSE: 4151), reported new data further defining the potential of mogamulizumab in the treatment of relapsed or refractory mycosis fungoides and Sézary syndrome, two subtypes of cutaneous T-cell lymphoma, will be featured at the World Congress of Cutaneous Lymphomas (WCCL) in Montréal, Canada.

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Drawing on complementary evidence streams, including patient-reported outcomes, comparative-effectiveness estimates, molecular biomarker signals, and real-world utilization, these analyses collectively provide a more complete understanding of the therapeutic profile and potential of mogamulizumab.

"The research being presented at WCCL reflects our continued commitment to generating evidence beyond initial clinical trials for mogamulizumab in patients with relapsed or refractory mycosis fungoides and Sézary syndrome," said Daniela van Eickels, MD, PhD, MPH, Chief Medical Officer, Kyowa Kirin North America. "In these difficult-to-treat blood cancers, innovative clinical research and real-world data generation is essential to advancing and informing treatment strategies. We look forward to sharing our findings and exchanging ideas with the expert community."

WCCL Presentations:

Improved symptoms and health-related quality of life in patients with mycosis fungoides and Sézary syndrome treated with mogamulizumab in the PROSPER study
Oral Presentation; Scientific Session 8A
Friday, June 26, 3:30-4:30 PM ET

Outcomes in relapsed/refractory mycosis fungoides or Sézary syndrome from the MAVORIC trial mogamulizumab arm versus a real-world Australian cohort receiving vorinostat
(Collaborative Study)
Oral Presentation; Scientific Session 3B
Thursday, June 25, 2:30-3:30 PM ET

Overall survival in patients with mycosis fungoides or Sézary syndrome in Denmark: comparative effectiveness of mogamulizumab versus standard of care
Oral Presentation; Scientific Session 3B
Thursday, June 25, 2:30-3:30 PM ET

Targeted sequencing in patients with relapsed/refractory mycosis fungoides mogamulizumab or Sézary syndrome treated with mogamulizumab in the MOGA-2MG-Q4W clinical trial
Oral Presentation; Scientific Session 4B
Thursday, June 25, 3:40-5:20 PM ET

Mogamulizumab treatment for mycosis fungoides in clinical practice in France: data from the ongoing multicentric prospective observational PROMED study
Exhibit Hall Poster Session
Thursday-Saturday, June 25-27

U.S. POTELIGEO (mogamulizumab-kpkc) Indication
POTELIGEO injection for intravenous infusion is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

Important Safety Information

WARNINGS AND PRECAUTIONS

Dermatologic toxicity: Monitor patients for rash throughout the course of treatment. For patients who experienced dermatologic toxicity in Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. Interrupt POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).

Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction.

Infections: Monitor patients for signs and symptoms of infection and treat promptly.

Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease.

Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications.

ADVERSE REACTIONS

The most common adverse reactions (reported in ≥10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%).

(Press release, Kyowa Hakko Kirin, JUN 10, 2026, View Source [SID1234666557])

Zemcelpro® (UM171 Cell Therapy) licensing and supply agreements announced for Canada

On June 10, 2026 ExCellThera Inc. ("ExCellThera"), a global leader in blood stem cell expansion and metabolic fitness technologies, together with its wholly owned subsidiary Cordex Biologics ("Cordex"), reported exclusive licensing and supply agreements granting Medexus the Canadian commercialization rights for Zemcelpro (dorocubicel), also known as UM171 Cell Therapy.

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Zemcelpro is a novel personalized cryopreserved hematopoietic stem cell transplantation product containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit. The product is used to treat hematological malignancies (blood cancers), such as leukemias and myelodysplasias. Given the product’s current stage of development in Canada, Medexus does not expect to begin commercializing the product before calendar year 2028 (depending on available regulatory pathways). As part of the regulatory process, Medexus intends to seek Health Canada approval of the brand name Zemcelpro.

"These agreements with Medexus represent today an important milestone and reflect our continued commitment to advancing Zemcelpro for patients with significant unmet medical needs," said David Millette, CEO of Cordex. "In addition to the strong commercial opportunity this partnership creates, we believe it has the potential to meaningfully improve access to innovative therapies for Canadian patients with high-risk blood cancers requiring allogeneic stem cell transplantation, where new treatment options remain critically needed."

Medexus is a leading specialty pharmaceutical company with extensive experience in hematology and oncology, making it a strong strategic fit for the partnership with Cordex.

Importantly, this agreement also represents a broader step forward in Cordex’s global commercialization strategy for Zemcelpro. Cordex continues to actively pursue additional strategic partnerships to support and accelerate the commercialization of Zemcelpro across Europe and other international markets.

"We believe there is substantial global interest in innovative therapies that address persistent unmet needs in blood malignancies and conventional stem cell transplantation, and we remain focused on identifying partners with the expertise, infrastructure, and shared vision necessary to expand patient access worldwide," said David Millette. "As we advance these discussions, our priority remains clear: bringing innovative and potentially life-changing therapies to patients who urgently need new treatment options while creating long-term value for our stakeholders."

The transaction includes royalties on Canadian net sales and milestone payments, creating a shared economic interest in the product’s long-term commercial success. Cordex will continue to manage the clinical program and will be responsible for the manufacturing and supply of Zemcelpro to Medexus.

About Zemcelpro

Zemcelpro (dorocubicel), also known as UM171 Cell Therapy, is a novel personalized cryopreserved haematopoietic stem cell transplantation product containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit.

Zemcelpro has recently received conditional marketing authorization from the European Commission for the treatment of adults with haematological malignancies requiring allogeneic haematopoietic stem cell transplantation following myeloablative conditioning, for whom no other suitable donor cells are available. For complete product information, including warnings and precautions for use and adverse reactions (and their appropriate management), please refer to the EU Summary of Product Characteristics (SmPC) for Zemcelpro.

Additional regulatory filings are planned for Zemcelpro with other health authorities, including in the US, Canada, the UK, and Switzerland.

Zemcelpro has been evaluated in over 120 patients with haematologic malignancies in clinical trials in the United States, Europe and Canada. Zemcelpro has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designations from the FDA as well as orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification and priority medicines (PRIME) designation from the EMA.

Zemcelpro has been tested in Phase 2 trials in patients with high- and very high-risk acute leukemias and myelodysplasias who have limited treatment options with low survival outcomes and high incidence of relapse under the current standard of care, including patients with patients with TP53 mutations or other genetic abnormalities, patients requiring a second transplant, and patients with refractory or active disease. A pivotal Phase 3 trial in this patient population will be initiated as soon as possible.

The use of Zemcelpro in other patient populations, including pediatric patients and patients with non-malignant haematological diseases, is also being investigated.

The product safety and efficacy have not yet been established by other regulatory agencies, such as the U.S. FDA, the MHRA and Health Canada.

(Press release, ExCellThera, JUN 10, 2026, View Source [SID1234666542])

Parexel to Showcase Seven Research Posters and Debut New Hematology Playbook at the European Hematology Association Congress 2026

On June 10, 2026 Parexel, a leading global clinical development partner providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry, reported its experts will present seven research posters during the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, June 11–14 in Stockholm, Sweden. Parexel’s presence at EHA (Free EHA Whitepaper) 2026 will also mark the launch of At the Turning Point: Shaping the Future of Hematology, a thought leadership resource grounded in the company’s expertise and insights from 250 hematology programs across nearly 70 countries over the past five years.

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Poster Presentations

Parexel researchers will present seven posters during EHA (Free EHA Whitepaper) 2026, including five in person and two available online. Poster abstracts are embargoed until June 11 at 8 a.m. CEST:

In-Person Presentations (all times are CEST):

"Comparative Real-World Overall Survival in Diffuse Large B-Cell Lymphoma: CAR T-Cell Therapies Versus Bispecific Antibodies"
First author: Vladimir Otasevic, M.D., Ph.D., Associate Medical Director
Date and time: Friday, June 12 from 6:45 p.m. – 7:45 p.m.
"ICANS After CAR-T Therapy: Persistent Cognitive but Not Psychiatric Risk — A Propensity Score-Matched Analysis"
First author: Heidi Cho, M.D., Vice President, Franchise Head and Global Therapeutic Area Head, Hematology
Date and time: Saturday, June 13 from 6:45 p.m. – 7:45 p.m.
"Impact of Autologous Stem Cell Transplantation Following Quadruplet Therapy (Dara-VRd) on Survival Outcomes in Multiple Myeloma: A Real-World Data Analysis"
First author: Lanzhu Yue, M.D., Ph.D., Medical Director, Therapeutic Area Head of Lymphoma and Non-Malignant Hematology
Date and time: Friday, June 12 from 6:45 p.m. – 7:45 p.m.
"Real-World Outcomes of Sickle Cell Disease Patients Transitioning From Pediatric to Adult Care: Impact on Acute Care Utilization"
First author: Heidi Cho, M.D., Vice President, Franchise Head and Global Therapeutic Area Head, Hematology
Date and time: Friday, June 12 from 6:45 p.m. – 7:45 p.m.
"Risk of Bleeding in Mantle Cell Lymphoma Patients Treated with Covalent Bruton Tyrosine Kinase Inhibitors and Contemporary Anticoagulant or Antiplatelet Agents: Real-World Data Insights"
First author: Vladimir Otasevic, M.D., Ph.D., Associate Medical Director
Date and time: Saturday, June 13 from 6:45 p.m. – 7:45 p.m.

Available Online:

"Infections Following Combined Therapy with a GPRC5DxCD3 Bispecific Antibody (Talquetamab) or BCMA Bispecific Antibodies (Elranatamab/Teclistamab) and Tocilizumab, in Multiple Myeloma Patients"
First author: Heidi Cho, M.D., Vice President, Franchise Head and Global Therapeutic Area Head, Hematology
"Regulatory Divergence in R/R AML: Contrasting FDA and EMA Approaches to Real-World Evidence and Trial Design"
First author: Sinan Sarac, M.D., Ph.D., Senior Vice President, Head of Oncology Europe, Regulatory Consulting

"Emerging therapies in hematology are advancing at an extraordinary pace, creating new opportunities to improve patient outcomes through longer remissions, more effective disease management and innovative treatment approaches," said Heidi Cho, M.D., Vice President, Franchise Head and Global Therapeutic Area Head, Hematology at Parexel, who will lead the company’s on-site activities at the meeting. "Our research presentations and new hematology playbook reflect the depth of experience Parexel has gained across hundreds of global hematology studies. Our experiences provide actionable insights to help sponsors navigate complexity, make critical development decisions with greater confidence and help bring transformative therapies to patients faster."

The European Hematology Association (EHA) (Free EHA Whitepaper) is the leading professional organization dedicated to the research, diagnosis and treatment of blood diseases, bringing together thousands of clinicians, scientists and industry professionals each year.

Launch of the Hematology Playbook

Authored by Parexel subject matter experts, At the Turning Point: Shaping the Future of Hematology addresses trial design innovation, patient-centric development strategies, navigation of the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and National Medicinal Products Administration (NMPA) regulatory landscape, operationalization of complex hematology trials, and the integration of real-world evidence from the start of development. The resource is written for hematology drug developers, including biotech and pharmaceutical sponsors approaching first-in-human studies, preparing for Phase III studies, and managing multi-regional development.

Key Findings

Five-year relative survival rates for blood cancers have climbed significantly over the past three decades, rising from 48% to 68% for leukemia and 32% to 62% for myeloma. As a result, the pool of patients eligible for clinical trials has shifted, intensifying competition for enrollment across hematology studies.
Patient navigation deployment drove a 29% decrease in screen fail rate across a Parexel-supported hematology study, with 100% of sites opting into navigator support.
Gene therapies for sickle cell disease and hemophilia approved between 2023 and 2025 have fallen short of projected commercial uptake, a pattern the playbook traces to poorly defined patient profiles during protocol design.
China’s investigator-initiated trial pathway can be approximately two years faster and substantially less costly than other traditional IND routes, positioning the country as a strategic accelerator for first-in-human hematology studies.

For more information about Parexel’s presence at EHA (Free EHA Whitepaper) 2026 or to schedule a meeting with Parexel experts, please visit Parexel Events. To access Parexel’s hematology playbook, visit Parexel Insights.

(Press release, PAREXEL International, JUN 10, 2026, View Source [SID1234666558])