On April 9, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Company’s resubmitted New Drug Application (NDA) for TLX101-Px1, (Pixclara2, Floretyrosine F 18 or 18F-FET), an investigational PET3 agent for the imaging of glioma (brain cancer), and has assigned a PDUFA4 goal date of September 11, 2026.

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The approval of TLX101-Px will fulfil a significant unmet medical need for the characterization of recurrent or progressive glioma from treatment related changes in both adult and pediatric patients5. Neuroimaging of glioma with 18F-FET is already broadly recommended in international clinical practice guidelines – including NCCN Guidelines6 – and TLX101-Px has been granted Orphan Drug7 and Fast Track8 designations by the FDA.

"There remains a critical unmet need in improving our ability to image residual glioma after treatment," said Thomas Hope, MD, Vice Chair, Department of Radiology and Biomedical Imaging, University of California, San Francisco (UCSF). "We have worked with Telix for the last three years to help leverage our clinical data to help make FET-PET9 available to patients in the United States."

Patrick Wen, MD, E. Antonio Chiocca, MD, PhD, Family Endowed Chair in Neuro-Oncology at Mass General Brigham Cancer Institute, added, "Distinguishing tumor progression from treatment-related change remains one of the most challenging aspects of glioma care. PET imaging with 18F-FET is an important tool in clinical practice worldwide, and the FDA’s acceptance of this application is a meaningful step toward broader access for patients and clinicians in the United States."

Kevin Richardson, CEO, Telix Precision Medicine, added, "The FDA’s acceptance of our NDA resubmission is an important milestone for Telix. We appreciate the FDA’s constructive engagement and look forward to working closely with the Agency to urgently obtain approval and then bring this product to market for the benefit of patients."

Telix’s FY 2026 financial guidance does not include any revenue contribution from TLX101-Px.

About TLX101-Px

TLX101-Px is a PET imaging candidate, which has been granted Fast Track and Orphan Drug designations by the FDA for the characterization of recurrent or progressive glioma from treatment related changes. TLX101-Px targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). This enables TLX101-Px to be potentially utilized as a patient selection and response assessment tool for Telix’s LAT1-targeting therapy candidate TLX101-Tx (iodofalan 131I), currently under investigation in the pivotal IPAX-BrIGHT trial in patients with recurrent glioblastoma10. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction.

About gliomas

Gliomas are diffusely infiltrative tumors that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) cancer that originates from glial cells, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors11. In the U.S., there are approximately 24,000 new glioma cases diagnosed annually12. Glioblastoma (GBM) is a high-grade glioma and the most common and aggressive form of primary brain cancer. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients13, with an expected survival duration of 12-15 months from diagnosis.

(Press release, Telix Pharmaceuticals, APR 9, 2026, View Source [SID1234664285])

On April 9, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported an expanded, multi-year collaboration with Gilead Sciences, Inc. (Nasdaq: GILD) aimed at building and advancing Gilead’s oncology pipeline.

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To date, Gilead has leveraged Tempus’ extensive repository of de-identified multimodal data to inform a range of oncology R&D initiatives, including trial design, indication selection, biomarker strategy, health outcomes analysis and clinical real world evidence. The expanded agreement provides Gilead with enterprise-wide access to Tempus’ AI-driven Lens platform, unlocking access to broader datasets across multiple indications and integrating dedicated Tempus analytical services.

"We are excited to announce this expanded partnership with Tempus that reflects our shared priority of putting patients at the heart of innovation," said Patrick Loerch, SVP of Clinical Data Science at Gilead Sciences. "By combining Gilead’s scientific expertise with Tempus’ real world data insights in oncology, we aim to maximize generation of key insights to help inform clinical decision making and ultimately improve care for cancer patients."

"By providing access to the Tempus multimodal data library, we are empowering the Gilead team to further fuel its R&D engine with AI-driven insights," said Ryan Fukushima, CEO of Tempus Data & Apps. "We are thrilled to expand this collaboration, offering the multimodal depth necessary to uncover critical biological insights. This approach helps navigate billions of data points to find the ‘signal in the noise,’ ultimately increasing the probability of success for life-altering medicines."

(Press release, Tempus, APR 9, 2026, View Source [SID1234664284])

On April 9, 2026 BostonGene, a developer of the leading AI foundation model for tumor and immune biology, reported that 13 abstracts have been selected for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, held from April 17 – 22, at the San Diego Convention Center in San Diego, CA. BostonGene will be exhibiting at booth #4613.

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BostonGene will demonstrate how its leading AI foundation model for tumor and immune biology is redefining the drug development lifecycle by providing biopharma partners with a biologically grounded roadmap from early discovery through late-stage clinical trials. Integrating genomic, transcriptomic, and spatial insights, BostonGene’s presentations highlight a sophisticated suite of AI-driven capabilities designed to accelerate and de-risk the pharmaceutical pipeline. Key research includes the use of ReadyScore and Lymphly for precision patient stratification and target identification, RNA-aware diffusion models to predict drug-induced tissue dynamics, and AI-based image batch correction to ensure trial data integrity by focusing on true biologic signals. Furthermore, in collaboration with leading institutions, BostonGene will showcase how longitudinal multiomic profiling identifies actionable biomarkers and resistance pathways often missed by traditional methods.

Details of BostonGene’s presentations at AACR (Free AACR Whitepaper) are below:

Oral presentation
Session: CT012
Title: A phase 2 single-arm open-label trial evaluating zanidatamab in patients with early-stage HER2-positive breast cancer: The NeoZanHER study
Date & time: April 18 | 12:50 PM – 1:00 PM
Presenter: Funda Meric-Bernstam, MD, UT MD Anderson

BostonGene’s integrated whole exome sequencing (WES) and RNA-seq platform was applied to uncover markers of response to HER2-targeting zanidatamab in a small cohort of patients with early-stage HER2-positive breast cancer. Early findings revealed high efficacy and manageable safety profile in select patients, underscoring the feasibility of de-escalating to HER2-targeted therapy alone for this cancer.

Research done in collaboration with UT MD Anderson

Poster presentations
Poster: 114
Title: Unraveling tumor- and tissue-specific gene expression patterns from plasma-derived cfRNA
Date & time: Sunday, April 19 | 2:00 PM – 5:00 PM
Presenter: Desiree Schenk, BostonGene

BostonGene explored the utility of minimally invasive plasma-derived cell-free RNA (cfRNA) profiling for deconvolving tumor- and tissue-specific signals from a single blood draw. We uncovered tumor- and tissue-specific expression patterns in cfRNA that correlated with donor health or cancer status. Our findings support cfRNA signatures as a clinically relevant resource for optimizing patient stratification, trial design, discovery of novel drug targets and plasma-based biomarkers, and disease and treatment response monitoring.

Poster: 0452
Title: Therapeutic potential of AURKA inhibition in ER+ inflammatory breast cancer
Date & time: April 19 | 2:00 PM – 5:00 PM
Presenter: Surbhi Shivhare, PhD, UT MD Anderson

Applying BostonGene’s Tumor PortraitTM to analyze samples from ER+ inflammatory breast cancer (IBC) tumors, researchers at MD Anderson discovered amplified AURKA expression and an inverse relationship between AURKA and SMARCA4 expression. These findings suggest SMARCA4 as a putative synthetic lethality partner of AURKA, where therapeutic targeting of both could lead to cell death. BostonGene’s Tumor PortraitTM integrated genomic and transcriptomic data with clinical data to generate biologically grounded, actionable insights.

Research done in collaboration with UT MD Anderson

Poster: 2437
Title: A comparative scoring framework for BCMA-, GPRC5D- and CD38-targeted therapies in multiple myeloma
Date & time: Monday, April 20 | 9:00 AM – 12:00 PM
Presenter: Konstantin Chernyshov, PhD, BostonGene

BostonGene leveraged ReadyScore, a proprietary, next-generation sequencing-based scoring framework for BCMA-, GPRC5D-, and CD38-targeted therapies in multiple myeloma. This molecular stratification tool integrates tumor and microenvironment features to provide a comprehensive readiness profile to predict CAR-T response, T-cell engagers and monoclonal antibodies. By highlighting target readiness and treatment resistance pathways, the framework enables more precise biomarker-driven patient selection, informs therapeutic prioritization, and offers potential utility for optimizing trial design and translational decision-making.

Poster: 1451
Title: Visualizing the genotype–phenotype link: Predicting drug-induced tissue dynamics with RNA-based diffusion models
Date & time: Monday, April 20 | 9:00 AM – 12:00 PM
Presenter: Alexander Bagaev, PhD, BostonGene

BostonGene presents an RNA-aware diffusion model that predicts tissue morphology from gene expression to better understand genotype–phenotype relationships in cancer. The model integrates RNA embeddings from over 20,000 genes with histological image generation, trained on extensive paired RNA and H&E datasets. It produced realistic tissue images and successfully simulated drug-induced gene expression changes, capturing biologically meaningful tissue dynamics such as tertiary lymphoid structures and B-cell signatures. The approach helps predict how drugs affect tissue architecture, improving drug candidate selection, guiding early trial design, and reducing risks in drug development.

Poster: 3877
Title: Integrative application of Lymphly reveals shared molecular landscape across B-cell lymphomas
Date & time: Monday, April 20 | 2:00 PM – 5:00 PM
Presenter: Konstantin Chernyshov, PhD, BostonGene

BostonGene applied Lymphly, a unique, stable genetic classification framework for diffuse large B-cell lymphoma (DLBCL). When applied to ~3,500 samples, it uncovered previously unrecognized molecular relationships between DLBCL subtypes and other B-cell lymphomas. The analysis identified distinct subtype–disease links and shared genetic patterns, improving understanding of how lymphomas may transform into DLBCL and highlighting potential therapeutic targets across the B-cell lymphoma landscape.

Poster: 1468
Title: Germline whole exome sequencing implicates homologous recombination repair pathway genes as risk factors in SMARCB1 deficient renal medullary phenotypes without sickle hemoglobinopathies
Date & time: April 20 | 9:00 AM – 12:00 PM
Presenter: Pankaj Kumar Chauhan, PhD, UT MD Anderson

BostonGene’s genomic analysis explored two rare and aggressive kidney cancers: renal medullary carcinoma (RMC) and renal cell carcinoma with medullary phenotype (RCCU-MP). The study found that while both cancers showed similar immune-rich tumor environments, distinct genomic alterations were present in RCCU-MP that were absent in RMC. These results point to new genetic risk factors in RCCU-MP and support broader germline testing for patients with RCCU-MP.

Research done in collaboration with UT MD Anderson

Poster: 3763
Title: CCR7 expression and spatial distribution in inflammatory breast cancer: A baseline characterization for therapeutic targeting
Date & time: April 20 | 2:00 PM – 5:00 PM
Presenter: Surbhi Shivhare, PhD, UT MD Anderson

In collaboration with The University of Texas MD Anderson Cancer Center, BostonGene applied its multimodal molecular profiling platform to advance target discovery in inflammatory breast cancer. By integrating genomic, transcriptomic, and spatial data, BostonGene uncovered key biological features of CCR7 that support its therapeutic relevance. This work highlights BostonGene’s ability to generate clinically actionable insights to prioritize targets, refine patient selection strategies, and accelerate oncology drug development.

Research done in collaboration with UT MD Anderson

Poster: 5251
Title: Precise description of metabolomic states using NGS uncover new potential biomarkers of response to TKIs in ccRCC
Date & time: Tuesday, April 21 | 9:00 AM – 12:00 PM
Presenter: Nikita Kotlov, PhD, BostonGene

BostonGene developed specific metabolic gene signatures to inform prediction of tyrosine kinase inhibitor (TKI) response in patients with clear cell renal cell carcinoma (ccRCC). Our refined metabolic signatures uniquely integrate transcriptomic and metabolic data to reveal strong associations with TKI response, overall survival and tumor microenvironment subtypes, representing potent candidate biomarkers for early-phase clinical trial design and patient stratification aimed at overcoming TKI resistance.

Poster: 4164
Title: Implementation of a diffusion-based color checker for histological image batch correction
Date & time: Tuesday, April 21 | 9:00 AM – 12:00 PM
Presenter: Alexander Bagaev, PhD, BostonGene

BostonGene will present a novel AI-powered tool to enhance histological image analysis through batch correction. Leveraging stable diffusion models, the tool standardizes whole slide images collected on different scanners by mitigating technical variations and artifacts. The diffusion-based framework optimizes AI-driven image analysis workflows, offering a scalable solution for harmonizing large multi-site histological datasets.

Poster: 5421
Title: Determining the benefit of comprehensive molecular testing in advanced cancers: BostonGene and Exigent Genomic INsight (BEGIN) study
Date & time: Tuesday, April 21 | 9:00 AM – 12:00 PM
Presenter: Sibel Blau, MD, Northwest Medical Specialties

The BEGIN study, a collaboration between BostonGene and the Exigent Research Network, evaluated integrated DNA/RNA genomic profiling in community oncology practices. Among patients with advanced cancers, 93% had actionable findings, with many identified through RNA sequencing only. Comprehensive results influenced treatment decisions, including matching patients to standard of care and ongoing trial options, highlighting the patient-level impact of combined DNA/RNA testing in expanding precision oncology options in community settings.

Research done in collaboration with Exigent Research Network Investigators

Poster: CT277
Title: IvoLoC trial: A phase II trial evaluating the efficacy of ivonescimab in metastatic endocrine refractory HR-positive HER2-negative or triple negative invasive lobular carcinoma (ILC)
Date & time: Tuesday, April 21 | 2:00 PM – 5:00 PM
Presenter: Jason Mouabbi, MD, UT MD Anderson

In an ongoing clinical trial with MD Anderson Cancer Center, BostonGene performed multimodal longitudinal blood and tissue analysis of metastatic invasive lobular carcinoma patients receiving the bispecific antibody targeting PD-1 and VEGF, ivonescimab. Beyond efficacy and durability, this study evaluated the molecular correlates linking clinical outcomes with tumor microenvironment subtypes while assessing circulating tumor DNA dynamics, biomarkers of response and resistance, and predictive responder scores.

Research done in collaboration with UT MD Anderson

Poster: 7935
Title: Multimodal immunotherapy remodels the tumor microenvironment in hepatocellular carcinoma: Integrative spatial and transcriptomic profiling from a Phase II trial
Date & time: April 22 | 9:00 AM – 12:00 PM
Presenter: Lionel Aurelien Kankeu Fonkoua, MD, Mayo Clinic Cancer Center

BostonGene’s spatial and transcriptomic analysis was used in a Phase II trial to show that combining radiotherapy, dendritic cell vaccination, PD-L1 blockade, and VEGF inhibition could reshape the tumor environment in hepatocellular carcinoma (HCC). This multimodal approach helped turn immune-resistant "cold" tumors into immune-active states, improving T-cell responses and vascular health. The findings highlight promising strategies to overcome treatment resistance in HCC and reinforce BostonGene’s role in advancing precision immunotherapy.

Research done in collaboration with Mayo Clinic

The abstracts will be published in an online-only Proceedings supplement to the AACR (Free AACR Whitepaper) journal Cancer Research.

(Press release, BostonGene, APR 9, 2026, View Source [SID1234664283])

On April 9, 2026 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, reported its participation in the Society of Interventional Radiology (SIR) 2026 Annual Scientific Meeting, taking place April 11–15, 2026, in Toronto, Ontario, Canada.

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TriSalus will showcase new clinical and preclinical data highlighting the capabilities of its Pressure Enabled Drug Delivery (PEDD) platform to enhance therapeutic delivery across multiple disease states.

Featured presentations include:

April 13, 2026 | 12:10 PM ET
David Jaroch, PhD (TriSalus Life Sciences)
Poster Presentation:
Pressure Enabled Drug Delivery During Delivery of Embolic Spheres Enhances Hepatic Tumor Penetration in an Oncopig Model
April 13, 2026 | 3:18 PM ET
Adam Robinson, MS (Tulane University) and Richard Marshall, MD (Tulane University and TriSalus Life Sciences)
Scientific Session Presentation:
Embolization of Neuroendocrine Tumor Metastases to the Liver: A Single-Center Experience Before and After the Introduction of Pressure Enabled Drug Delivery
April 14, 2026 | 3:36 PM ET
Francis Kang, MD (Rutgers Robert Wood Johnson Medical School)
Scientific Session Presentation:
Novel Approaches to Uterine Artery Embolization: A Clinical Assessment of Safety and Efficacy Using a Pressure Enabled Drug Delivery Device
Additional abstracts and presentation materials are available at:
View Source

"These presentations continue to expand the growing body of evidence supporting PEDD as a differentiated approach to improving therapeutic delivery," said Mary Szela, Chief Executive Officer of TriSalus Life Sciences. "We are particularly encouraged by the breadth of applications—from liver-directed therapies to uterine artery embolization—demonstrating the versatility of our platform."

Richard Marshall, MD, Chief Medical Officer of TriSalus, added, "Our work reflects a broader commitment to advancing interventional oncology and embolization techniques. I am excited to see data ranging from pre-clinical to investigator-initiated studies in human subjects across multiple indications presented in this forum. By enabling more effective delivery of therapies, PEDD has the potential to improve outcomes across multiple indications and expand the treatment toolbox for interventional radiologists."

(Press release, TriSalus Life Sciences, APR 9, 2026, View Source [SID1234664282])

On April 9, 2026 DualityBio ("DualityBio" or the "Company", Stock Code: 9606.HK) reported that the Biologics License Application (BLA) for the investigational antibody-drug conjugate ("ADC") trastuzumab pamirtecan ("T-Pam", also known as DB-1303 or BNT323), has been accepted for review by the China National Medical Products Administration (NMPA). With the BLA filing, DualityBio is seeking approval for trastuzumab pamirtecan as second-line treatment for patients with unresectable or metastatic HER2-positive breast cancer. The application is based on positive interim results from the pivotal Phase III clinical trial (Study DB-1303-O-3001).

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The DB-1303-O-3001 trial is a randomized, controlled, open-label, multicenter Phase III clinical trial conducted in China. It aims to evaluate the efficacy and safety of trastuzumab pamirtecan compared to trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and taxane chemotherapy. As assessed by the Independent Data Monitoring Committee (IDMC), the trial has met its primary endpoint of statistically significant improvement of progression-free survival (PFS, assessed by Blinded Independent Central Review, BICR) for trastuzumab pamirtecan compared to T-DM1 at a pre-specified interim analysis.

Dr. Hua Mu, Global Chief Medical Officer of DualityBio, stated: "China has over 350,000 new breast cancer cases annually [1], representing a high incidence rate and ranking as the second most common cancer among Chinese women. We are delighted to see that DB-1303/T-Pam has achieved a milestone in its commercialization progress, demonstrating its potential to provide an effective new treatment option for breast cancer patients. In the China market, we have entered into a collaboration with 3SBio to jointly advance the commercialization of multiple indications of DB-1303/T-Pam in Chinese mainland, Hong Kong and Macao. Globally, we will continue to deepen our global strategic partnership with BioNTech to further drive the global development of this product. DB-1303/T-Pam is a globally co-developed new drug with strong strategic partners in both China and global markets. We will work closely together to accelerate the product’s marketing approval process, maximize its global clinical value, present more treatment options to patients worldwide."

About trastuzumab pamirtecan (BNT323/DB-1303)

Trastuzumab pamirtecan ("T-Pam", also known as BNT323 or DB-1303) is a third-generation topoisomerase-1 inhibitor-based ADC targeting HER2 which is being developed by BioNTech and DualityBio. Trastuzumab pamirtecan was built from DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates ("DITAC") platform. HER2 is a surface-expressed protein on solid tumors and has been linked to the aggressive growth and spread of cancer cells, making it a potential target for innovative cancer therapeutics. The candidate has exhibited antitumor activity in both HER2-positive and HER2-low tumor models as well as in several solid tumor indications, including patients with breast and endometrial cancers, as well as other advanced solid tumors. Preclinical data and preliminary clinical data for trastuzumab pamirtecan indicate its potential to target HER2 receptors on solid tumors irrespective of expression level with a manageable safety profile and a potentially expanded therapeutic window. Trastuzumab pamirtecan is currently being evaluated in multiple solid tumor types and innovative treatment combinations, including two global pivotal clinical trials in first-line HER2-low, hormone receptor positive ("HR+") metastatic breast cancer (DYNASTY-Breast02; NCT06018337) and second-line endometrial cancer (BNT323-01; NCT06340568), a novel-novel combination Phase 1/2 clinical trial (BNT323-03; NCT06827236) evaluating trastuzumab pamirtecan in combination with pumitamig in HR-positive or –negative, HER2-low, -ultra-low, or -null advanced/metastatic breast cancer and a Phase III, randomized, multi-site, open-label trial of BNT323/DB-1303 Versus Investigator’s Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent Endometrial Cancer (NCT06340568) .

The BNT323/DB-1303 program received the Fast Track designation and Breakthrough Therapy designation from the U.S. Food and Drug Administration ("FDA") for the treatment of endometrial cancer in 2023.

(Press release, DualityBio, APR 9, 2026, View Source [SID1234664281])