Telix Pharmaceuticals Ltd 6-K, filed Dec 8, 2025
Telix Pharmaceuticals Ltd (TLX)
6-K
2025-12-08
For: 2025-12-07
View Original
Added on
April 07, 2026
About this 6-K
Telix Pharmaceuticals Ltd filed this 6-K on December 8, 2025.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of December, 2025
Commission File Number: 001-42128
Telix Pharmaceuticals Limited
(Translation of registrant’s name into English)
55 Flemington Road
North Melbourne, Victoria 3051, Australia
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
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INFORMATION CONTAINED IN THIS FORM 6-K REPORT
On December 8, 2025 (Melbourne, Australia), Telix Pharmaceuticals Limited filed an announcement with the Australian Securities Exchange titled “1st Patient Dosed in ProstACT Global Randomized Tx Expansion,” which is attached to this Form 6-K as Exhibit 99.1.
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Press release – December 8, 2025
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Telix Pharmaceuticals Limited
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Date: December 8, 2025
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By:
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/s/ Genevieve Ryan
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Name: Genevieve Ryan
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Title: Company Secretary
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Telix Pharmaceuticals LimitedACN 616 620 369
55 Flemington Road
North Melbourne
Victoria, 3051
Australia
ASX ANNOUNCEMENT
ProstACT Global Phase 3 Update: First Patient Dosed in Randomized Treatment Expansion, Part 1 Readout Plans Confirmed
Melbourne (Australia) and Indianapolis, IN (U.S.) – 8 December 2025. Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that the first patient has been dosed in Part 2 (randomized treatment expansion) of its ProstACT Global Phase 3 study evaluating its lead prostate cancer therapy candidate TLX591 (lutetium (177Lu) rosopatamab tetraxetan) in patients with metastatic castration resistant prostate cancer (mCRPC). The patient was dosed at the Australian Prostate Centre (APC) in Melbourne, Australia.
ProstACT Global is the first Phase 3 trial to combine a PSMA1-targeted radio antibody-drug conjugate (rADC) therapy administered together 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 patients in Australia, New Zealand and Canada.
As previously agreed with FDA and disclosed to the market, Telix will submit Part 1 data to the United States (U.S.) Food and Drug Administration (FDA) to enable clearance to expand Part 2 of the trial to U.S. sites. A public disclosure of preliminary results from Part 1 of the study will be aligned to engagement with the FDA.
The study is also approved to commence in China, Japan2, Singapore, South Korea, Türkiye and the United Kingdom. As part of the further global expansion of the trial, Telix will file a clinical trial application (CTA) with the European Medicines Agency (EMA) to enable expansion into EU sites.
Dr. David N. Cade, Group Chief Medical Officer, Telix, commented, “Dosing the first patient into Part 2 of the randomized treatment expansion of ProstACT Global trial is a significant milestone for Telix’s late-stage prostate cancer therapeutics pipeline. We look forward to presenting the preliminary data from Part 1 of the study to the FDA and EMA in the coming months3.”
About ProstACT Global
ProstACT Global (ClinicalTrials.gov ID: NCT06520345) is an international, multicenter trial in two parts: Part 1, safety and dosimetry lead-in with 30 patients (target enrollment complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a 68Ga-PSMA-11 PET4 imaging agent (such as Illuccix® or Gozellix®, kits for the preparation of gallium-68 (68Ga) gozetotide injection) following prior treatment with an androgen receptor pathway inhibitor (ARPI).
The antibody approach demonstrates different targeting and pharmacology to that observed in other PSMA-targeted small peptide radioligand therapies (RLT). In contrast to these therapies5, collective long-term follow-up of patients administered with TLX591 has not observed significant acute or delayed kidney toxicity, as the agent is cleared through the liver, instead of the kidneys6. Due to its
1 Prostate-specific membrane antigen.
2 Japanese regulator Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval for a Japan-specific Part 1 in nine patients, prior to commencing Part 2.
3 Collation of available published data. Not from head-to-head studies, cross trial or product data should be interpreted with caution.
4 Positron emission tomography.
5 Tagawa et al. Curr Oncol Rep. 2021; Steinhelfer et al. JNM. 2024.
large molecular weight, TLX591 also demonstrates minimal salivary and lacrimal gland uptake, reducing dry mouth and dry eyes, common adverse effects of existing PSMA-targeted RLTs7.
Additional information on the Phase 3 ProstACT Global study can be found at:
https://telixpharma.com/prostact/
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® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA8. TLX591 has not received a marketing authorization in any jurisdiction.
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
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
Media Contact
Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com
This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
6 Tagawa et al. Cancer. 2019.
7 Pepin et al. Pract Radiat Oncol. 2025.
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; 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.
8 Telix ASX disclosure 21 March 2025.