Telix Pharmaceuticals Ltd ADR Stock Price, News & Analysis

Telix (ASX/NASDAQ: TLX) announced a strategic clinical collaboration with Varian, a Siemens Healthineers company, on Dec 10, 2025 to develop integrated theranostics and external beam radiation therapy (EBRT) applications.

The initial investigational focus is PSMA-PET imaging for prostate cancer, evaluating Gozellix and Illuccix to help select patients for EBRT, support personalized plans (including Varian Ethos adaptive radiotherapy), and monitor response. The agreement enables both company‑sponsored and investigator‑led clinical studies and is structured as a broad framework for future co‑development across Telix’s PET candidates including Zircaix (TLX250-CDx) and Pixclara (TLX101-CDx).

Safety notes in the release highlight image interpretation limitations, radiation exposure risks, and adverse reaction data from studies (960 and 1003 patients) with mostly low rates of nausea, diarrhea, dizziness and fatigue.

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.

Telix Pharmaceuticals (NASDAQ: TLX) announced its participation in two upcoming healthcare investment conferences. CEO Dr. Christian Behrenbruch will participate in fireside chats at the Morgan Stanley Global Healthcare Conference on September 8, 2025, at 4:50 p.m. ET and the H.C. Wainwright Global Investment Conference on September 9, 2025, at 12:00 p.m. ET.

Both conferences will be held in New York, with sessions available via live webcast and on-demand through the company's investor relations website.