Welcome to our dedicated page for Telix Pharmaceuticals ADR news (Ticker: TLX), a resource for investors and traders seeking the latest updates and insights on Telix Pharmaceuticals ADR stock.
Telix Pharmaceuticals Limited (TLX) delivers targeted radiopharmaceutical solutions for cancer diagnosis and therapy. This news hub provides investors and healthcare professionals with essential updates on clinical advancements, regulatory milestones, and strategic initiatives shaping precision oncology.
Access real-time announcements covering therapeutic developments, partnership agreements, and financial disclosures. Our curated repository ensures efficient tracking of TLX's progress in radioligand therapy and diagnostic imaging innovations, particularly in prostate cancer management.
Key updates include FDA submission statuses, trial phase results, and manufacturing expansions. The content supports informed analysis of Telix's market position without speculative commentary, maintaining compliance with financial reporting standards.
Bookmark this page for streamlined access to primary-source materials and objective reporting on TLX's contributions to nuclear medicine. Regular updates reflect the company's commitment to transforming cancer care through radiopharmaceutical science.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) has announced promising preliminary results from its Phase 2 IPAX-Linz study of TLX101 therapy for recurrent high-grade glioma. The study, combining TLX101 with external beam radiation therapy (EBRT), demonstrated a median overall survival of 12.4 months from treatment initiation, or 32.2 months from initial diagnosis.
The trial included eight patients, with treatment well-tolerated and no serious adverse events reported. Five patients had MGMT unmethylated tumors, typically associated with poor prognosis. The results corroborated the positive efficacy signal from the earlier IPAX-1 study, which showed 13 months median survival from treatment.
Telix is advancing its TLX101 development program with ongoing IPAX-2 study in front-line glioblastoma. The company has submitted for ethics approval a registration-enabling study, planning to begin patient enrollment at Australian sites in H2 2025, with U.S. sites expansion following an IND application in H1 2025.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) has selected Cardinal Health (NYSE: CAH) as a commercial radiopharmaceutical distributor for Gozellix®, its FDA-approved next-generation PSMA-PET imaging agent for prostate cancer in the United States.
Cardinal Health will deploy Telix's ARTMS QUANTM Irradiation System® (QIS®) cyclotron technology for standardized, high-efficiency production of gallium-68 used with Gozellix®. The distribution agreement enables multi-Curie local production and broader availability across U.S. locations, with commercial launch planned for H1 2025.
Cardinal Health will serve as a strategic radiopharmacy distributor alongside Telix's in-house radiopharmacy network, expanding their existing partnership which includes distribution of Illuccix® and Zircaix®.
Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) has appointed Dr. Paul Schaffer as its new Chief Technology Officer (CTO), effective April 07, 2025. Dr. Schaffer joins from ARTMS Inc., where he served as CTO for seven years, and TRIUMF, Canada's particle accelerator research centre, where he was Director of Life Science since 2012.
In his new Vancouver-based role, Dr. Schaffer will oversee Telix's technological advancement in radiopharmaceutical research, development, and clinical applications. His responsibilities will encompass chemistry, physics, artificial intelligence, dosimetry, and data analytics, working alongside Chief Scientist Dr. Michael Wheatcroft's team.
Dr. Schaffer is notably recognized for developing the ARTMS QUANTM Irradiation System® (QIS®) for large-scale isotope production, which was later acquired by Telix in 2024, and for transforming TRIUMF's Life Sciences program, including the design of a multi-cyclotron radiochemistry facility.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) has appointed Anne Whitaker as a Non-Executive Director, effective April 7, 2025. Whitaker brings over 30 years of global corporate experience in pharmaceutical, biotech, and specialty pharmaceutical sectors, including clinical research and manufacturing organizations.
Currently serving as a Non-Executive Director at Icon PLC (NASDAQ: ICLR) and Chair at QurAlis , Whitaker's most recent executive role was as Chair and CEO of Aerami Therapeutics Holdings. Her career includes senior leadership positions at GlaxoSmithKline, Sanofi, and Bausch Health. She holds a Bachelor of Science in Chemistry and Business from the University of North Alabama.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) has announced the dosing of the first patient in its Phase 1 ZOLAR trial of TLX300-CDx at the Melbourne Theranostic Innovation Centre. The trial evaluates 89Zr-olaratumab in patients with advanced, metastatic soft tissue sarcoma (STS).
The first-in-human study aims to assess safety, pharmacokinetics, biodistribution, and optimal dosing of TLX300-CDx. The diagnostic agent targets PDGFRα, a protein commonly overexpressed in STS. The trial's findings will guide the selection of therapeutic radionuclides for future treatment applications.
Telix holds exclusive worldwide rights to develop radiolabelled forms of olaratumab, originally developed by Eli Lilly. The company plans to develop a targeted radionuclide therapy for STS patients, addressing the current challenges in treating metastatic disease that typically responds poorly to chemotherapy.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) has received FDA approval for Gozellix®, a next-generation PSMA-PET imaging agent for prostate cancer. The product is designed for PET scanning of PSMA positive lesions in men with suspected metastasis or recurrence.
Key features of Gozellix® include:
- Extended shelf life up to 6 hours
- Wider distribution radius compared to existing products
- Enhanced efficiency and scheduling flexibility for scanning clinics
- Expected full reimbursement with reduced/no patient co-insurance
The product will be available alongside Telix's first-generation product Illuccix®, targeting the 3.4 million men living with prostate cancer in the U.S. who currently have access to PSMA-PET imaging. The approval aims to improve accessibility to precision medicine scanning, particularly in underserved populations.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) has received approval from Brazil's Health Regulatory Agency (ANVISA) for Illuccix®, its prostate cancer imaging agent. This marks the first PSMA-PET imaging agent approval in Latin America.
The approved diagnostic agent is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer, specifically for those with suspected metastasis candidates for initial therapy and those with suspected recurrence based on elevated PSA levels.
The marketing authorization is granted to Telix's partner R2PHARMA, Brazil's leading cold kit manufacturer and nuclear pharmacy network. Additionally, Telix announced a joint venture with R2PHARMA (Telix Innovations Brazil, Ltda.) to commercialize and distribute Telix's therapeutic and diagnostic radiopharmaceuticals in Brazil. The Brazilian radiopharmaceuticals market is projected to reach US$330 million over the next decade.
Telix Pharmaceuticals (ASX/Nasdaq: TLX) has announced a breakthrough in lead-212 (212Pb) isotope production technology. The company has developed and validated a new generator technology through its IsoTherapeutics team that produces 212Pb using a sealed Thorium-228 source.
The innovative generator technology offers significant improvements over existing solutions, including:
- Increased radioactivity, yield, and shelf life
- Fully automated operation
- Small, single hot cell footprint
- Capacity to produce up to 60 clinical doses per elution
- Potential for further scaling
The technology is designed for deployment across Telix's manufacturing and distribution networks, including the recently acquired RLS Radiopharmacies network. Lead-212, with its 10.6-hour half-life, is considered promising for Targeted Alpha Therapy (TAT), and this development addresses previous commercial scalability limitations.
Telix Pharmaceuticals (ASX/Nasdaq: TLX) announces an upcoming investor webinar focused on its urologic oncology portfolio. The educational session will feature presentations from three global experts discussing the company's late-stage and next-generation radiotherapeutic candidates.
The panel includes: Dr. Neeraj Agarwal presenting on the ProstACT Global Phase 3 trial of TLX591 for prostate cancer; Dr. Eric Jonasch discussing the STARLITE studies of TLX250 in combination with immunotherapy for clear cell renal cell carcinoma; and Dr. Rodney Hicks covering TLX592 and targeted alpha therapies in prostate cancer treatment.
The 1.5-hour webinar is scheduled for Tuesday, March 11, 2025, at 5:30 PM EDT (Wednesday, March 12, 8:30 AM AEDT).
Telix Pharmaceuticals (ASX/Nasdaq: TLX) announces FDA acceptance of Biologics License Application (BLA) for TLX250-CDx (Zircaix®), their kidney cancer PET imaging agent, with Priority Review status and PDUFA date of August 27, 2025.
TLX250-CDx is positioned to become the first commercially available imaging agent for accurate, non-invasive diagnosis of clear cell renal cell carcinoma (ccRCC). The technology targets carbonic anhydrase IX (CAIX), expressed on 95% of ccRCC cells.
The BLA submission is supported by the Phase 3 ZIRCON study results, showing 86% sensitivity, 87% specificity, and 93% positive predictive value for ccRCC detection. The study results, published in The Lancet Oncology (September 2024), highlight the product's potential to revolutionize kidney cancer management similar to PSMA-PET/CT's impact on prostate cancer diagnostics.
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