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) generates a steady flow of news related to its radiopharmaceutical pipeline, commercial portfolio, and global operations. As a biopharmaceutical company focused on therapeutic and diagnostic radiopharmaceuticals and associated medical technologies, its announcements often highlight progress in oncology and rare disease programs, regulatory milestones, and commercial performance.
Recent Telix news has covered precision medicine portfolio updates, including Phase 3 data for TLX591-CDx (Illuccix) in China, regulatory interactions for TLX101-CDx (Pixclara) and TLX250-CDx (Zircaix) with the U.S. Food and Drug Administration, and inclusion of TLX250-CDx in international renal imaging guidelines. The company also reports on clinical collaborations, such as its agreement with Varian to explore combining Telix’s theranostic products with external beam radiation therapy.
Investors and clinicians following TLX news can expect updates on clinical trial milestones (for example, first patient dosed in the SOLACE trial for TLX090 or in the BiPASS Phase 3 trial for prostate cancer diagnosis), as well as information on reimbursement and market access developments. Telix has announced CMS Transitional Pass-Through status and a permanent HCPCS code for Gozellix in the United States, along with country-level approvals and launches for Illuccix in Europe and the United Kingdom.
Telix also issues news on financial performance and guidance, such as quarterly revenue updates and full-year revenue outlook, and on participation in major healthcare conferences where management presents the company’s pipeline and commercial strategy. For users tracking TLX, the news stream provides insight into how Telix advances its radiopharmaceutical products from clinical development through regulatory review and commercialization across multiple regions.
Telix (ASX: TLX, NASDAQ: TLX) will report full year results for the period ended 31 December 2025 on Friday, 20 February 2026 AEDT (Thursday, 19 February 2026 EST).
An investor webcast and conference call is scheduled for 9:30 a.m. AEDT on 20 February 2026 (5:30 p.m. EST on 19 February 2026). Registration is available via the company webcast link.
Telix (ASX/NASDAQ: TLX) reported unaudited FY 2025 Group revenue of ~US$804M (A$1.2B), in line with upgraded guidance of US$800–820M, and Q4 2025 revenue of ~US$208M (Q4 YoY +46%). Growth was led by the Precision Medicine business (~US$161M in Q4) supported by the successful U.S. launch of Gozellix after CMS reimbursement effective 1 Oct 2025. Key program and commercial milestones include first patients dosed in multiple therapeutic and imaging trials (ProstACT Part 2, SOLACE, BiPASS, Japan TLX591-Px study), NMPA acceptance of TLX591-Px NDA in China, ~55% national PSMA-PET share in Australia, and a strategic collaboration with Varian to explore combinations with external beam radiation therapy.
Telix (TLX) announced the first U.S. patient has been dosed in BiPASS, a Phase 3 trial evaluating Illuccix and Gozellix 68Ga-PSMA-11 PET agents in the pre-biopsy prostate cancer diagnosis setting. The prospective, open-label study will enroll 250 patients across the U.S. and Australia and is designed to support marketing authorization for 68Ga-PSMA-PET in the pre-biopsy pathway. The trial will assess whether combining MRI with 68Ga-PSMA-11 PET improves diagnostic accuracy, reduces unnecessary biopsies (up to 75% of U.S. biopsies are reportedly negative), and enables better patient stratification and biopsy precision if objectives are met.
Telix (ASX/NASDAQ: TLX) will present a pipeline and commercial-portfolio overview at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco.
Dr. Christian Behrenbruch, Managing Director and Group CEO, will present on Monday, 12 January 2026 at 9:00 am PST (12:00 pm EST / 4:00 am AEDT, 13 January). The presentation will be webcast live and available on demand for 30 days via the company Investor Relations website. Telix will also publish a dedicated presentation detailing all therapeutic pipeline assets. Telix plans to release Q4 2025 financials on 20 January 2026.
Telix (ASX: TLX, NASDAQ: TLX) provided a precision medicine portfolio update on Dec 21, 2025 covering three PET imaging candidates.
TLX591-CDx (Illuccix): Phase 3 China study (n=140) met its primary endpoint with overall patient-level PPV 94.8% (95% CI: 85.9%, 98.2%), region-level PPV 100% in prostate bed and non-bone metastases, and a 67.2% treatment-plan change rate; Telix and partner plan a near-term NDA submission in China.
TLX101-CDx (Pixclara) NDA resubmission is being finalized after collaborative FDA interactions. TLX250-CDx (Zircaix) had a Type A FDA meeting; Telix says CMC remediation alignment reached and an additional January meeting scheduled to review comparability data.
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.
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