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 (ASX: TLX, NASDAQ: TLX) reported ZIRCON-X results showing TLX250-CDx (Zircaix) PET/CT would change clinical management in 48.6% (143/294) of patients with indeterminate renal masses versus standard imaging.
Of those, 31 patients (≈21% of changes) could have avoided invasive biopsy and 110/294 (37.4%) would have had a major management change; ~30% had treatment escalation or de-escalation. A subset of 18 patients moved from planned active surveillance to immediate treatment. The data will be presented at the SUO annual meeting, Dec 2–5, 2025.
Telix (ASX: TLX; NASDAQ: TLX) will participate in two upcoming investor events: the UBS Global Healthcare Conference in Palm Beach, FL and the Jefferies Global Healthcare Conference in London.
Speakers & schedule: Kevin Richardson, CEO Precision Medicine, will join a UBS fireside chat on Mon, Nov 10, 2025 at 12:30pm EST (Tue, Nov 11 at 4:30am AEDT). Richard Valeix, CEO Therapeutics, will join a Jefferies fireside chat on Tue, Nov 18, 2025 at 10:00am GMT (9:00pm AEDT).
Both sessions will be webcast live and accessible via Telix’s Investor Relations events page for registration and replay.
Telix (ASX: TLX, NASDAQ: TLX) said on October 23, 2025 that SNMMI, EANM and ACNM guidelines now include its investigational PET agent TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab) for molecular imaging of renal masses. The guideline panel cited the agent's ability to improve visualization versus 18F-FDG PET and referenced Telix's pivotal Phase 3 ZIRCON trial results: sensitivity 86%, specificity 87% and PPV 93% for identifying clear cell renal cell carcinoma (ccRCC), including small lesions.
The summary notes TLX250-CDx binds CAIX, expressed on >95% of ccRCC, and that guideline endorsement may support clinical adoption, subject to regulatory approval.
Telix (ASX: TLX, NASDAQ: TLX) announced dosing of the first patient in the Phase 1 SOLACE trial of TLX090 (153Sm-DOTMP) on Oct 22, 2025. SOLACE is an open-label study enrolling up to 33 patients with advanced cancer and bone metastases to evaluate pharmacokinetics, dosimetry, safety, and pain palliation. TLX090 is described as a next-generation radiopharmaceutical optimized to target bone tumors and potentially provide a non-opioid systemic option for durable pain relief.
The program aims to compare TLX090 to legacy 153Sm treatments to support a streamlined registration pathway; TLX090 has not received marketing authorization in any jurisdiction.
Telix (ASX: TLX, NASDAQ: TLX) reported unaudited Q3 2025 group revenue of $206 million, up 53% year-over-year, and raised FY 2025 revenue guidance to $800–$820 million. PSMA imaging revenue was $155 million (Q3 2025), and RLS third‑party revenue was $47 million. The U.S. Centers for Medicare & Medicaid Services granted Level II HCPCS code and Transitional Pass-Through payment for Gozellix effective 1 Oct 2025. Illuccix gained approval in 19 European markets plus the UK, with commercial launches underway in several countries. Telix confirmed a 20–25% YoY increase in R&D spend guidance and disclosed a $51.7 million final royalty buyout payment made in July 2025.
Telix Pharmaceuticals (NASDAQ: TLX) has achieved a significant milestone as the U.S. Centers for Medicare & Medicaid Services (CMS) granted Transitional Pass-Through (TPT) payment status for Gozellix®, its next-generation PSMA-PET imaging agent for prostate cancer.
The TPT status, effective October 1, 2025, enables separate reimbursement under the Hospital Outpatient Prospective Payment System and eliminates the 20% patient coinsurance. Gozellix® features an extended six-hour shelf life and broader distribution radius compared to existing gallium-based products. The agent can be prepared via both gallium generators and cyclotron-based methods, offering improved efficiency and scheduling flexibility for scanning clinics.
Telix Pharmaceuticals (NASDAQ: TLX) has initiated its Phase 3 BiPASS clinical trial by dosing the first patient, aiming to expand indications for Illuccix® and Gozellix® in prostate cancer diagnosis. The study will evaluate if combining MRI and PSMA-PET imaging can improve diagnostic accuracy and potentially help patients avoid unnecessary biopsies.
The trial will enroll 204 patients across Australia and the United States. The study builds upon promising research from PRIMARY and PRIMARY2 studies, which demonstrated benefits of combined imaging approaches. If successful, this could expand Telix's U.S. market for PSMA-PET imaging agents by approximately 800,000 scans, addressing a significant clinical need given that up to 75% of current prostate biopsies are negative.
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