Telix and Varian Announce Strategic Theranostics-EBRT Clinical Collaboration

Rhea-AI Summary

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.

Key Figures

Gozetotide patients (safety) 960 patients PSMA-PreRP and PSMA-BCR studies, one dose each

Average injected activity 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi) Gallium Ga-68 gozetotide in PSMA-PreRP and PSMA-BCR

Common adverse events <1% incidence Nausea, diarrhea, dizziness with gallium Ga-68 gozetotide

VISION study sample 1003 patients Metastatic prostate cancer receiving gallium Ga 68 gozetotide

VISION injected activity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi) Single intravenous dose in VISION study

Fatigue incidence 1.2% Adverse reaction in metastatic prostate cancer patients (VISION)

Nausea incidence 0.8% Adverse reaction in metastatic prostate cancer patients (VISION)

Constipation/vomiting 0.5% each Adverse reactions in metastatic prostate cancer patients (VISION)

Market Reality Check

$9.92 Last Close

Volume Volume 105,332 is 11% above the 20-day average, indicating slightly elevated activity before this release. normal

Technical Shares at $9.62 trade below the 200-day MA $13.81 and sit close to the 52-week low of $8.76, well under the 52-week high of $30.36.

Peers on Argus

Biotech peers show mixed, mostly modest moves (e.g., APLS +0.17%, LGND -1.83%, MLTX -2.74%), with no clear, coordinated sector trend explaining TLX’s slight pre-news decline.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 19	Clinical impact data	Positive	-1.5%	ZIRCON-X showed TLX250-CDx could alter management in many renal mass cases.
Nov 05	Conference participation	Neutral	+0.1%	Investor conference appearances signaled ongoing engagement with healthcare investors.
Oct 23	Guideline inclusion	Positive	+0.9%	TLX250-CDx added to major renal imaging guidelines, supporting potential adoption.
Oct 22	Trial initiation	Positive	+0.9%	First patient dosed in SOLACE trial for TLX090 in metastatic bone pain.
Oct 14	Revenue and guidance	Positive	+5.2%	Strong Q3 revenue and upgraded FY 2025 guidance highlighted commercial traction.

Pattern Detected

Recent fundamentally positive updates (trial progress, guideline inclusion, strong revenues) have usually been followed by share price gains, with one notable negative reaction to favorable clinical data.

Recent Company History

Over the last few months, Telix has reported several constructive developments. On Oct 14, it posted $206M in Q3 2025 revenue and raised full-year guidance to $800–$820M, which saw a 5.24% price rise. Subsequent news highlighted TLX250-CDx guideline inclusion and first dosing in the SOLACE trial, both followed by modest gains. More recently, ZIRCON-X data showing management changes in 48.6% of renal mass patients was met with a -1.53% move, indicating occasional divergence from positive clinical catalysts. Today’s collaboration extends Telix’s theranostic strategy into EBRT workflows.

Market Pulse Summary

This announcement outlines a strategic collaboration with Varian to integrate Telix’s theranostic radiopharmaceuticals and PSMA-PET imaging into external beam radiation therapy workflows. The focus on Gozellix and Illuccix in prostate cancer, plus pipeline agents like TLX250-CDx and TLX101-CDx, extends Telix’s precision oncology footprint. In context of prior revenue growth to $206M in Q3 2025 and upgraded $800–$820M guidance, key watchpoints include clinical study outputs, integration into radiation oncology practice, and evolving safety and usage data.

Key Terms

theranostics medical

"to develop novel clinical applications that combine Telix’s theranostic products and external beam radiation therapy"

Theranostics combines a medical test with a targeted treatment so the same approach both finds disease and delivers therapy—like a guided missile that first locates a target then destroys it. For investors, it matters because pairing diagnosis and therapy can speed identification of patients who will benefit, reduce wasted treatments, create dual revenue streams (tests plus drugs), and alter regulatory and reimbursement dynamics that affect commercial potential.

external beam radiation therapy medical

"to develop novel clinical applications that combine Telix’s theranostic products and external beam radiation therapy (EBRT)"

External beam radiation therapy is a medical treatment that directs high-energy beams from a machine outside the body toward a specific area, usually to shrink or destroy tumors; think of it as aiming a focused spotlight at a single spot inside the body without cutting. It matters to investors because its use, effectiveness, and technological advances influence sales of medical equipment, hospital treatment volumes, drug and device partnerships, regulatory decisions and reimbursement policies that affect companies’ revenue and growth prospects.

ebrt medical

"EBRT is a widely used and validated treatment suitable for most solid malignant tumors."

External beam radiation therapy (EBRT) is a cancer treatment that uses a machine outside the body to aim focused, high-energy rays at a tumor—think of it like a spotlight concentrating energy on a small target to damage cancer cells while limiting exposure to nearby healthy tissue. Investors watch EBRT because advances in technique, equipment, clinical outcomes, approvals or reimbursement can change demand for devices, software and treatment services, influencing revenue and growth for healthcare companies.

psma-pet medical

"The first area of investigational focus is PSMA-PET1 imaging for prostate cancer radiotherapy patients."

A PSMA-PET scan is a medical imaging test that uses a tiny radioactive tracer that sticks to a protein commonly found on prostate cancer cells, allowing a PET scanner to highlight tumors and metastases like a GPS map for cancer. It matters to investors because it can change how accurately disease is detected and staged, influence treatment choices, and drive demand, reimbursement and sales for imaging agents, scanners and related services.

hypersensitivity reactions medical

"Hypersensitivity Reactions to SulfitesAscorbic Acid Stabilizer contains sodium metabisulfite"

Hypersensitivity reactions are unwanted immune system overreactions to a drug, vaccine, medical device, or other substance that can range from mild rashes and itching to severe, potentially life-threatening allergic responses. Investors care because these reactions can change a product’s safety label, delay approvals, trigger additional testing or warnings, reduce market use, or lead to recalls and legal exposure—similar to a false alarm that forces costly changes to a building’s safety plan.

androgen deprivation therapy medical

"Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway"

Androgen deprivation therapy is a medical treatment that lowers or blocks male hormones (androgens) to slow the growth of hormone-sensitive cancers, most commonly prostate cancer. Think of it as cutting off the fuel a fire needs so the blaze slows; for investors, changes in ADT use, new ADT drugs, or clinical trial results can affect demand for medications, device procedures, safety profiles and long-term revenue for healthcare companies.

AI-generated analysis. Not financial advice.

MELBOURNE, Australia and PALO ALTO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces a strategic clinical collaboration with Varian, a Siemens Healthineers company and global leader in radiation oncology, to develop novel clinical applications that combine Telix’s theranostic products and external beam radiation therapy (EBRT).

EBRT is a widely used and validated treatment suitable for most solid malignant tumors. This treatment is typically delivered by radiation oncologists who play a central role in managing cancer across multiple stages of the patient journey. The role of EBRT and radiation oncology in treating cancer could potentially be enhanced by integrating with therapeutic radiopharmaceuticals and precision diagnostics. Working with Varian, a key player in EBRT, Telix will explore how theranostics can be used more effectively by radiation oncologists to enhance patient selection and deliver targeted treatment.

The first area of investigational focus is PSMA-PET¹ imaging for prostate cancer radiotherapy patients. Telix and Varian aim to identify opportunities to utilize Gozellix® (kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection) and Illuccix® (kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection)² in selecting patients for EBRT, developing personalized treatment plans (particularly in the context of Varian’s Ethos adaptive radiotherapy), and monitoring responses to treatment. The agreement supports both company-sponsored and investigator-led clinical studies, enabling robust clinical exploration of novel approaches.

While the initial focus is on PSMA imaging, the collaboration has been implemented as a general framework for future co-development opportunities, with broad clinical applicability. This includes other PET imaging candidates in Telix’s pipeline, such as TLX250-CDx (Zircaix®³) and TLX101-CDx (Pixclara®³), as well as potential future therapeutic radiopharmaceuticals. By combining radiopharmaceutical theranostics with Varian’s EBRT technology, the companies believe radiation oncologists are uniquely positioned to lead both definitive and palliative treatment strategies.

Dr. Arthur Kaindl, Head of Varian, said, "Collaborating with Telix opens a powerful pathway to embed precision imaging and theranostics into the radiation therapy workflow, advancing how we personalize and optimize treatment decisions. By combining Telix’s strength in molecular imaging and radiopharmaceuticals with Varian’s leadership in radiation therapy and treatment planning, we are shaping a future of more targeted, patient-focused cancer care."

Dr. Christian Behrenbruch, Group CEO and Managing Director, Telix, said, "This strategic partnership with Varian represents a transformative opportunity to bring precision imaging into the heart of radiation oncology. Integrating theranostics into EBRT has the potential to improve patient outcomes. And by combining Telix’s innovation in molecular imaging with Varian’s global leadership in cancer treatment technologies, we are building alliances to explore new frontiers in personalized cancer care."

IMPORTANT SAFETY INFORMATION (GOZELLIX)

WARNINGS AND PRECAUTIONS
Risk for Misinterpretation
Image interpretation errors can occur with GOZELLIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy
The performance of GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of GOZELLIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Radiation Risks
Gallium Ga-68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

Hypersensitivity Reactions to Sulfites
Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

ADVERSE REACTIONS
The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

DRUG INTERACTIONS
Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established.

Please note that this information is not comprehensive.

Please see the Full Prescribing Information here.

IMPORTANT SAFETY INFORMATION (ILLUCCIX)
WARNINGS AND PRECAUTIONS

Risk for Misinterpretation
Image interpretation errors can occur with Illuccix PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy
The performance of Illuccix for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of Illuccix for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Radiation Risks
Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS
The safety of gallium Ga 68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

In the VISION study, 1003 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). Adverse reactions occurring at ≥0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in the clinical study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%). Adverse reactions occurring at a rate of < 0.5% in the VISION study were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills.

DRUG INTERACTIONS
Androgen deprivation therapy and other therapies targeting the androgen pathway
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

Please note that this information is not comprehensive.
Please see the Full Prescribing Information here.

You are encouraged to report suspected adverse reactions 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.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Illuccix®, Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® has been approved by the United States Food and Drug Administration (FDA)⁴.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details, and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook

About Varian

At Varian, a Siemens Healthineers company, we envision a world without fear of cancer. For more than 75 years, Varian has developed, built, and delivered innovative technologies and solutions that help care providers around the globe treat millions of patients each year. Today, as a Siemens Healthineers company, we support every step of the cancer care journey – from screening to survivorship. From advanced imaging and radiation therapy to comprehensive software and services, to interventional radiology, we are harnessing the power of our perspective while also pursuing clinical research to create a more efficient, and more personalized care pathway. Because, for cancer patients everywhere, their fight is our fight. For more information, visit http://www.varian.com

Telix Investor Relations (Global)

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

Telix Investor Relations (U.S.)  

Annie Kasparian  
Telix Pharmaceuticals Limited  
Director Investor Relations and Corporate Communications  
Email: annie.kasparian@telixpharma.com 

Telix Media Contact

Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com

Varian Media Contact

Kristin Corey
Kristin.Corey@varian.com

Legal Notices

Cautionary Statement Regarding Forward-Looking Statements. 

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs, including its strategic collaboration with Varian; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties.

©2025 Telix Pharmaceuticals Limited. All rights reserved.

¹ Imaging of prostate-specific membrane antigen with positron emission tomography.
² Combined usage is not currently approved in any jurisdiction globally.
³ Products and brand names subject to final regulatory approval.
⁴ Telix ASX disclosure 21 March 2025.

FAQ

What did Telix and Varian announce on December 10, 2025 regarding TLX?

They announced a strategic clinical collaboration to combine Telix theranostics with Varian EBRT technology, with an initial focus on PSMA-PET imaging for prostate cancer.

How will Gozellix and Illuccix be used in the Telix–Varian collaboration (TLX)?

Gozellix and Illuccix will be evaluated for patient selection, personalized EBRT planning (including Ethos adaptive radiotherapy), and treatment response monitoring.

Does the Telix–Varian agreement (TLX) support investigator‑led studies?

Yes; the collaboration explicitly supports both company‑sponsored and investigator‑led clinical studies.

Which other Telix PET candidates are included in the collaboration framework with Varian?

The framework mentions TLX250-CDx (Zircaix) and TLX101-CDx (Pixclara) as potential co‑development candidates.

What safety limitations did Telix note for Gozellix and Illuccix in the announcement?

The release warns image interpretation can be misleading, gallium Ga‑68 uptake is not prostate‑specific, cumulative radiation exposure risks exist, and sulfite hypersensitivity may occur.

What adverse reaction data did Telix report for gallium Ga‑68 gozetotide?

Safety was evaluated in 960 patients in PSMA‑PreRP/PSMA‑BCR studies and 1,003 patients in VISION; common reactions were nausea, diarrhea, dizziness (<1%) and fatigue (1.2% in VISION).