Telix Pharmaceuticals Limited

Telix Pharmaceuticals Limited Telix is a clinical-stage biopharmaceutical company developing diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR).

Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic oncology products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs in oncology and rare diseases. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com. Please see full Illuccix Prescribing Information:https://illuccixhcp.com/wp-content/uploads/illuccix-prescribing-information.pdf

Telix provides an update on its commercial and operational performance for Q4 2025.The Company delivered full-year reven...
20/01/2026

Telix provides an update on its commercial and operational performance for Q4 2025.

The Company delivered full-year revenue of US$804M (A$1.2B), achieving upgraded guidance.

The Precision Medicine business delivered excellent sequential growth in the quarter, driven in part by the successful U.S. launch of Gozellix, following CMS reimbursement.

Telix continues to advance multiple late-stage therapeutic programs, with first patients dosed in the SOLACE Phase 1 study for TLX090-Tx in metastatic bone pain and Part 2 of the ProstACT® Global Phase 3 study of TLX591-Tx .

For more on our Q4 2025 results, visit: https://telixpharma.com/news-views/telix-achieves-fy-2025-guidance-with-us804m-a1-2b-revenue-accelerates-growth-with-gozellix-launch/

TLX591-Tx and TLX090-Tx have not received marketing authorizations in any jurisdiction.

Telix’s New Drug Application (NDA) for TLX591-Px (Illuccix®, Kit for the preparation of ⁶⁸Ga-PSMA-11), has been accepted...
19/01/2026

Telix’s New Drug Application (NDA) for TLX591-Px (Illuccix®, Kit for the preparation of ⁶⁸Ga-PSMA-11), has been accepted for review by the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE).

The NDA was submitted with Telix’s strategic partner for the Greater China region, Grand Pharma.

Seeking a broad label that reflects clinical utility across multiple stages of prostate cancer care, the submission includes data from the Illuccix China Pivotal Phase 3 Registration study, which reported positive top-line results in December 2025.

Read more on our website here: https://telixpharma.com/news-views/chinese-nmpa-accepts-new-drug-application-for-illuccix-for-prostate-cancer-imaging/

Telix has announced a strategic clinical collaboration with Varian, a Siemens Healthineers company, to develop novel cli...
10/12/2025

Telix has announced a strategic clinical collaboration with Varian, a Siemens Healthineers company, to develop novel clinical applications that combine Telix’s theranostic products and external beam radiation therapy (EBRT).

The initial investigational focus is PSMA-PET imaging for prostate cancer radiotherapy patients. Telix and Varian will assess how Illuccix® (kit for the preparation of 68Ga-PSMA-11 injection) and Gozellix® (kit for the preparation of 68Ga-PSMA-11 injection) may support patient selection for EBRT, inform personalized treatment planning and monitor response to treatment.

The collaboration also creates a framework for broader future co-development across Telix’s investigational pipeline, including TLX250-CDx (Zircaix®) and TLX101-CDx (Pixclara®), as well our therapeutic candidates. By combining radiopharmaceuticals with EBRT, the companies aim to support radiation oncologists in delivering more precise, targeted cancer care.

Read more on our website here: https://bit.ly/3MQt6ms

TLX250-CDx and TLX101-CDx have not received a marketing authorization in any jurisdiction. Zircaix and Pixclara brand names subject to final regulatory approval.

The first patient has been dosed in Part 2 (randomized treatment expansion) of Telix’s Phase 3 ProstACT Global study eva...
07/12/2025

The first patient has been dosed in Part 2 (randomized treatment expansion) of Telix’s Phase 3 ProstACT Global study evaluating our lead prostate cancer therapy candidate, TLX591, in patients with metastatic castration-resistant prostate cancer (mCRPC).

The patient was dosed at the Australian Prostate Centre in Melbourne, Australia. This is an important milestone in this innovative trial – which is the first Phase 3 trial to combine TLX591 with Standard of Care (SOC; abiraterone, enzalutamide or docetaxel) versus SOC alone.

Part 2 of ProstACT Global will enroll approximately 490 patients and is currently recruiting in Australia, New Zealand and Canada, with further expansion approved across China, Singapore, South Korea, Türkiye and the United Kingdom.

Read more on our website here: https://telixpharma.com/news-views/prostact-global-phase-3-update-first-patient-dosed-in-randomized-treatment-expansion-part-1-readout-plans-confirmed/

TLX591 has not received a marketing authorization in any jurisdiction.

Join Telix this week at the 2025 Society of Urologic Oncology (SUO) Annual Meeting, one of the world’s leading internati...
01/12/2025

Join Telix this week at the 2025 Society of Urologic Oncology (SUO) Annual Meeting, one of the world’s leading international congresses dedicated to advances in urologic cancer care, being held in Phoenix (AZ).

Telix will showcase 3 of the Phase 3 studies from its urology development program, including:

🔵 ProstACT Global, Telix’s lead prostate cancer therapy candidate, TLX591, in metastatic castration-resistant prostate cancer;

🔵 BiPASS, ⁶⁸Ga-PSMA-11 PET combined with MRI for the detection of prostate cancer; and

🔵 ZIRCON-X, evaluating the impact of Telix’s kidney cancer imaging candidate, TLX250-CDx, on clinical decision-making in patients with indeterminate renal masses.

Swipe the carousel to explore presentations and session times.

Follow the link to learn more: https://telixpharma.com/telix-at-suo-2025/

TLX250-CDx and TLX591 have not received a marketing authorization in any jurisdiction.

Telix has officially opened Telix Manufacturing Solutions (TMS) in Yokohama, Japan, our first cyclotron facility in the ...
24/11/2025

Telix has officially opened Telix Manufacturing Solutions (TMS) in Yokohama, Japan, our first cyclotron facility in the Asia Pacific region.

The opening was commemorated with a lecture delivered by Professor Jun Hatazawa, Vice President of the Japan Isotope Association, on “Trends and Challenges for the Future of Nuclear Medicine.”

The site will initially support clinical supply of TLX250-CDx in the region for kidney cancer imaging, with plans to expand to additional investigational and future commercial products, subject to regulatory approval.

Read more here: https://bit.ly/49EmHUX

TLX250-CDx has not received a marketing authorization in any jurisdiction.

Results from the ZIRCON-X study show that almost half of all patients imaged with Telix’s kidney cancer imaging candidat...
19/11/2025

Results from the ZIRCON-X study show that almost half of all patients imaged with Telix’s kidney cancer imaging candidate, TLX250-CDx (Zircaix®), would have undergone a change in clinical management when compared with baseline standard-of-care imaging.

New analysis found that 48.6% of patients would have experienced a management change, and over 20% of these patients could have potentially avoided invasive biopsy. More than a third of evaluable patients would have undergone a major change, including escalation or de-escalation of treatment.

ZIRCON-X was a non-interventional, prospective, post-hoc study using imaging data from the parent pivotal Phase 3 ZIRCON study to assess the impact of TLX250-CDx PET/CT on decision-making for patients with indeterminate renal masses (IRMs).

The data will be presented at the 26th Annual Meeting of the Society of Urologic Oncology (SUO) being held in Phoenix, AZ from December 2 to 5.

Read more on our website: https://bit.ly/3XB7LzB

TLX250-CDx has not received a marketing authorization in any jurisdiction. Brand name subject to final regulatory approval.

12/11/2025

During , we’re celebrating the culture of Quality that underpins everything we do at Telix.

Rujeela, one of our Quality Leads, discusses how Quality is a shared responsibility across every part of the organization - built on collaboration, problem-solving, and a constant focus on patients.

It’s how we continuously improve and deliver safe, reliable, and innovative products that make a difference for patients worldwide.

Do you see yourself at Telix?

Explore open roles and learn more about our culture: https://telixpharma.com/careers

Final results from the Phase 2 OPALESCENCE trial of TLX250-CDx (⁸⁹Zr-girentuximab) in metastatic triple negative breast ...
12/11/2025

Final results from the Phase 2 OPALESCENCE trial of TLX250-CDx (⁸⁹Zr-girentuximab) in metastatic triple negative breast cancer (mTNBC) have been published in the European Journal of Nuclear Medicine and Molecular Imaging.

The investigator-initiated trial - conducted at ICO in France under the supervision of Dr. Caroline Rousseau - evaluated the safety and diagnostic utility of Telix’s CAIX-targeting PET imaging candidate in this aggressive breast cancer subtype, as proof of concept for therapy.

Authors conclude that TLX250-CDx “is a sensitive imaging method and offers promise for novel theranostics for mTNBC patients”.

These findings build on a growing body of evidence supporting the expansion of Telix’s CAIX-targeting theranostic programs into new indications beyond kidney cancer.

Read more on our website: https://bit.ly/43s7VwJ

TLX250-CDx has not received a marketing authorization in any jurisdiction.

Today, on Veterans Day, we honor the courage, sacrifice, and service of all Veterans.As we pause to recognize their dedi...
11/11/2025

Today, on Veterans Day, we honor the courage, sacrifice, and service of all Veterans.

As we pause to recognize their dedication, we are reminded of the importance of supporting their ongoing health and wellbeing. Prostate cancer affects Veterans at higher rates, and awareness, early detection, and access to care can make a life-changing difference.

We also acknowledge the incredible Veterans working at Telix. Their dedication to our mission and improving patient outcomes is a testament to the strength and commitment shown by Veterans everywhere.

Thank you to all who have served, and to those who continue to serve🎗️

For prostate cancer resources for Veterans, see here: https://zerocancer.org/help-and-support/resources-for/veterans

Join Telix at two upcoming investor conferences to learn more about the company’s growth strategy, commercial progress, ...
05/11/2025

Join Telix at two upcoming investor conferences to learn more about the company’s growth strategy, commercial progress, and theranostic pipeline.

🔵 Kevin Richardson, CEO, Precision Medicine, will join a fireside chat at the UBS Global Healthcare Conference.

🔵 Richard Valeix, CEO, Therapeutics, will take part in a fireside chat at the Jefferies Global Healthcare Conference.

Both sessions will be webcast live and available on demand.

For details and registration, visit: ir.telixpharma.com/events-presentations

A new home for Telix clinical trials.Finding the right trial can often be complex. Telix’s new Clinical Trials page is d...
30/10/2025

A new home for Telix clinical trials.

Finding the right trial can often be complex. Telix’s new Clinical Trials page is designed to make information about our global theranostic studies easier to find and navigate for patients, carers and the wider community.

With clear summaries, straightforward navigation and regularly updated content, the site supports greater awareness and access to information about our clinical programs.

🔗 Explore the new site: https://clinicaltrials.telixpharma.com

Address

55 Flemington Road, North
Melbourne, VIC
3051

Opening Hours

Monday 9am - 5pm
Tuesday 9am - 5pm
Wednesday 9am - 5pm
Thursday 9am - 5pm
Friday 9am - 5pm

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Our Story

Telix Pharmaceuticals Limited was established in January 2017. We are a clinical-stage biotechnology company developing a pipeline of molecularly-targeted radiation (MTR) therapies to image and treat cancer. Our team is an experienced group of biopharma clinicians and executives, with a passion for radiation biology and oncology.

In December 2018, Telix acquired ANMI SA, a leader in the field of radiopharmaceutical development. The ANMI team brings a wealth of innovation and experience in the streamlined development and production of novel radiopharmaceuticals. For more information about ANMI, visit anmi.be.

Our products currently focus on unmet needs in cancer care, specifically in:


  • Prostate