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Telix Announces Collaborations to Explore PSMA-PET Imaging in Emerging Prostate Cancer Treatment Approaches

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Telix (ASX/NASDAQ: TLX) announced letters of intent to collaborate with EDAP and Profound Medical to explore investigational use of its PSMA-PET imaging agents Gozellix and Illuccix with minimally invasive, image-guided ablative therapies for localized prostate cancer, including robotic HIFU and MRI-guided TULSA.

Initial work will focus on patient selection, treatment planning, post-treatment monitoring and clinical evidence generation to inform best practices and support emerging workflows aiming to preserve healthy tissue and reduce side effects.

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AI-generated analysis. Not financial advice.

Positive

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Negative

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Key Figures

Convertible bonds: US$600M Quarterly revenue: US$240M Revenue growth: 63% year-over-year +5 more
8 metrics
Convertible bonds US$600M Settlement of convertible bonds (Form 6-K, Apr 22, 2026)
Quarterly revenue US$240M Q2 2025 top-line revenue (Form 6-K, Jul 22, 2025)
Revenue growth 63% year-over-year Q2 2025 revenue growth rate
EU assessment period 210 days Active assessment for TLX101-Px MAA in Europe
PPV 98% TLX250-Px Phase 3 ZIRCON analysis PPV for renal malignancy
Sensitivity 82% TLX250-Px Phase 3 ZIRCON analysis sensitivity
Specificity 87% TLX250-Px Phase 3 ZIRCON analysis specificity
Gallium isotope Ga 68 Isotope used in Gozellix and Illuccix imaging agents

Market Reality Check

Price: $10.56 Vol: Volume 100,636 is below t...
normal vol
$10.56 Last Close
Volume Volume 100,636 is below the 20-day average of 142,700, indicating subdued trading interest ahead of this news. normal
Technical Shares at 10.86 are trading above the 200-day MA of 9.39, reflecting an established upward bias before the collaboration announcement.

Peers on Argus

Among tracked biotech peers, only ZLAB appeared in momentum scans, up about 2.36...
1 Up

Among tracked biotech peers, only ZLAB appeared in momentum scans, up about 2.36%, while others showed mixed to negative moves. With limited peer strength and is_sector_move=false, the reaction around TLX appears more stock-specific than sector-driven.

Historical Context

5 past events · Latest: May 04 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
May 04 Renal imaging data Positive -1.0% Phase 3 ZIRCON analysis showed strong TLX250-Px diagnostic performance across RCC subtypes.
Apr 30 EU MAA accepted Positive +2.4% European regulators accepted TLX101-Px MAA for glioma PET imaging with 210-day assessment.
Apr 29 Phase 2 PSMA data Positive +5.5% OPTIMAL-PSMA Phase 2 data for TLX597-Tx supported dose intensification and further study.
Apr 27 Educational webinar Positive +0.4% Announced webinar on PSMA-targeted therapy and multi-product prostate cancer strategy.
Apr 21 ASCO late-breaker Positive +1.2% ProstACT Global Phase 3 Part 1 safety data selected as late-breaking oral at ASCO 2026.
Pattern Detected

Recent Telix news has generally seen positive price alignment, with four of the last five announcements followed by gains and one divergence on otherwise constructive clinical data.

Recent Company History

Over recent months Telix has reported several clinically focused milestones. On Apr 21, Part 1 data from the ProstACT Global Phase 3 trial in mCRPC was selected as a late‑breaking abstract at ASCO 2026, with a 1.17% price gain. Subsequent prostate and PSMA‑therapy updates, including Phase 2 OPTIMAL‑PSMA data on Apr 29 with a 5.47% move, and educational outreach on Apr 27, reinforced a prostate‑cancer–centric narrative. Kidney imaging and glioma MAA news on May 4 and Apr 30 showed mixed but generally constructive price responses, framing today’s collaboration as part of a broader imaging and therapy integration strategy.

Market Pulse Summary

This announcement highlights Telix’s strategy to integrate PSMA-PET imaging with minimally invasive ...
Analysis

This announcement highlights Telix’s strategy to integrate PSMA-PET imaging with minimally invasive ablative technologies such as robotic HIFU and TULSA in localized prostate cancer. It follows a series of PSMA‑centric updates, including OPTIMAL‑PSMA Phase 2 data and the ProstACT Phase 3 late‑breaking abstract, underscoring a focus on imaging‑guided therapy workflows. Investors may watch for concrete clinical‑evidence outputs from these collaborations, regulatory progress on related agents, and how successfully Telix embeds its diagnostics into partner treatment platforms.

Key Terms

psma-pet, high-intensity focused ultrasound, hifu, molecular imaging
4 terms
psma-pet medical
"explore the investigational use of Telix’s PSMA-PET1 imaging agents Gozellix"
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.
high-intensity focused ultrasound medical
"with robotic high-intensity focused ultrasound (HIFU), and other image-guided therapies"
A noninvasive medical technique that uses tightly focused beams of ultrasound energy to heat and destroy targeted tissue inside the body without cutting skin, like using a magnifying glass to burn a small spot from a distance. It matters to investors because devices and services using this technology can offer lower-cost, lower-risk alternatives to surgery, so regulatory approvals, clinical results, and reimbursement decisions can significantly affect company sales and valuation.
hifu medical
"with robotic high-intensity focused ultrasound (HIFU), and other image-guided therapies"
High-Intensity Focused Ultrasound (HIFU) is a non-invasive medical treatment that uses tightly focused ultrasound waves to heat and destroy targeted tissue inside the body without cutting skin, like using a magnifying glass to burn a tiny spot with sunlight. For investors, HIFU matters because it represents a device and therapy market where clinical results, regulatory approvals, equipment sales, and insurance coverage determine revenue potential and adoption rates.
molecular imaging medical
"advancing the integration of molecular imaging into the evolving prostate cancer"
Molecular imaging is a medical technique that uses specialized scans and tracers to see biological processes at the cellular or molecular level inside the body, like using a GPS to track where activity is happening rather than just taking a photo. For investors, it matters because these tools can speed diagnosis, guide drug development, and help companies demonstrate a therapy’s effect earlier and more precisely, potentially reducing time and cost to market.

AI-generated analysis. Not financial advice.

  • Telix to partner with companies developing advanced minimally invasive and image-guided ablative technologies for prostate cancer.
  • Initial focus on patient selection, treatment planning and post-treatment monitoring; evidence generation to inform best practice.
  • Aim to accelerate adoption of novel therapeutic workflows to enhance clinical decision making and patient outcomes.

MELBOURNE, Australia and INDIANAPOLIS, May 15, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that it has entered into letters of intent to pursue collaborations with EDAP TMS S.A. (NASDAQ: EDAP, “EDAP”) and Profound Medical Corp. (NASDAQ: PROF, TSX: PRN, “Profound”), leading companies developing advanced minimally invasive and image-guided treatment ablative technologies for prostate cancer, including focal, subtotal, and whole-gland treatment approaches. These initiatives reflect Telix’s commitment to advancing the integration of molecular imaging into the evolving prostate cancer treatment landscape to help inform clinical decision-making.

The collaborations will explore the investigational use of Telix’s PSMA-PET1 imaging agents Gozellix® (kit for the preparation of gallium Ga 68 gozetotide) and Illuccix® (kit for the preparation of gallium Ga 68 gozetotide) with robotic high-intensity focused ultrasound (HIFU), and other image-guided therapies designed to treat localized prostate cancer, such as transurethral ultrasound ablation (TULSA).

Telix’s intention is to work with select partners to explore how PSMA-PET imaging may support emerging therapy workflows, which aim to preserve healthy tissue and minimize the risk of side effects such as incontinence and impotence. Collaborative activities will focus on non-promotional scientific, educational, and research engagement2.

“We are uniquely designed to enable the integration of PSMA-PET imaging with Focal One’s real-time ultrasound and fully robotic energy delivery to optimize treatment efficacy while minimizing side effects,” said Ryan Rhodes, EDAP Chief Executive Officer. “As the market leader in robotic focal therapy, with a growing global installed base, this collaboration will accelerate the development and standardization of treatment strategies to further personalize focal therapy treatments using Telix’s PSMA-PET imaging agents and Focal One Robotic HIFU.”

“Emerging clinical evidence suggests PSMA imaging may support prostate whole-gland, partial-gland, and focal ablation workflows, from treatment planning through post-treatment monitoring,” said Arun Menawat, Profound’s Chief Executive Officer and Chairman. “In collaboration with Telix, we look forward to exploring optimized workflows and generating clinical evidence that may help establish best practices and accelerate adoption of PSMA-PET imaging and the MRI-guided TULSA Procedure.”

“Precision medicine requires precision treatment strategies,” said Kevin Richardson, CEO, Telix Precision Medicine. “As disruptive technologies continue to transform prostate cancer care, we believe PSMA-PET imaging has the potential to play an important role in helping inform clinical decision-making across a range of minimally invasive and image-guided treatment approaches. We are excited to explore collaborations with market leaders in EDAP and Profound that may further advance personalized care for patients.”

About EDAP TMS SA

A recognized leader in robotic energy-based therapies, EDAP TMS develops, manufactures, promotes, and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics, and precise non-invasive energy delivery, EDAP introduced the Focal One® in Europe and the United States as a leading prostate focal therapy platform controlled by urologists, with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit focalone.com.

About Profound Medical Corp.

Profound is a commercial-stage medical device company and an innovator in interventional MRI procedures. The company’s flagship platform, TULSA-PRO®, enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure™ to see, ablate, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care—from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care using prostate tissue ablation, while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.

Profound Medical’s technologies are approved across major global markets. TULSA-PRO is cleared by the FDA in the United States for transurethral ultrasound ablation (TULSA) of prostate tissue. In addition, TULSA-PRO is cleared for use in various jurisdictions including Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE. 

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.

Injection site pain has been identified during postapproval use of ILLUCCIX.

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 global biopharmaceutical company focused on the development and commercialization of radiopharmaceuticals with the goal of addressing significant unmet medical need in oncology and rare diseases. 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 listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

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.

Telix Investor Relations (Global)

Ms. Kyahn Williamson
SVP Investor Relations and Corporate Communications
kyahn.williamson@telixpharma.com
Telix Investor Relations (Australia)

Ms. Charlene Jaw
Associate Director Investor Relations
charlene.jaw@telixpharma.com
Telix Investor Relations (U.S.)  

Ms. Annie Kasparian  
Director Investor Relations and Corporate Communications  
annie.kasparian@telixpharma.com 
   
Telix Media Contact (U.S.)

Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com
EDAP Investor Relations

Louisa Smith
Gilmartin Group
investor.relations@focalone.com
Profound Investor Relations

Stephen Kilmer
647.872.4849 (Mobile)
skilmer@profoundmedical.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; 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, including as a result of war or other geopolitical conflicts; 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.

©2026 Telix Pharmaceuticals Limited. All rights reserved.

______________________________________
1 Imaging of prostate-specific membrane antigen.
2 PSMA-PET imaging is not currently approved for specific treatment-planning indications associated with these emerging therapies.


FAQ

What did Telix (TLX) announce on May 15, 2026 about PSMA-PET imaging collaborations?

Telix announced letters of intent to collaborate with EDAP and Profound Medical to explore PSMA-PET imaging in prostate cancer treatment workflows. According to Telix, the focus is on integrating Gozellix and Illuccix with minimally invasive, image-guided ablative therapies for localized prostate cancer.

How will Telix (TLX) work with EDAP on robotic HIFU for prostate cancer?

Telix plans to explore using its PSMA-PET imaging agents with EDAP’s Focal One robotic high-intensity focused ultrasound (HIFU) system. According to Telix, the aim is to optimize treatment efficacy, support focal therapy planning, and help minimize side effects such as incontinence and impotence.

What role will PSMA-PET imaging play in Profound Medical’s TULSA Procedure with Telix (TLX)?

Telix and Profound intend to investigate PSMA-PET imaging in MRI-guided transurethral ultrasound ablation (TULSA) workflows. According to Telix, the collaboration will explore optimized treatment planning and post-treatment monitoring and generate clinical evidence that may help establish best practices for prostate ablation approaches.

How could the Telix (TLX) collaborations impact prostate cancer patient selection and monitoring?

The collaborations are expected to study PSMA-PET imaging for patient selection, treatment planning and post-treatment monitoring in localized prostate cancer. According to Telix, evidence generation will focus on how imaging may support personalized minimally invasive therapies while aiming to preserve healthy tissue.

Are the Telix (TLX) prostate cancer collaborations with EDAP and Profound commercial agreements?

Telix reported entering letters of intent to pursue collaborations, rather than final commercial contracts. According to Telix, activities will center on non-promotional scientific, educational and research engagement related to integrating PSMA-PET imaging into evolving prostate cancer treatment workflows.

What prostate cancer treatment approaches are targeted in Telix’s (TLX) new PSMA-PET collaborations?

The collaborations will explore PSMA-PET imaging with focal, subtotal and whole-gland treatment approaches for localized prostate cancer. According to Telix, this includes robotic HIFU and MRI-guided TULSA, with an emphasis on minimally invasive, image-guided ablative technologies supporting precision treatment strategies.