TLX Telix Pharmaceuticals

Telix Doses First Patient in Phase 3 IPAX-BrIGHT Trial of TLX101-Tx for Recurrent Glioblastoma

Telix Doses First Patient in Phase 3 IPAX-BrIGHT Trial of TLX101-Tx for Recurrent Glioblastoma

MELBOURNE, Australia and INDIANAPOLIS, April 15, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that the first patient has been dosed with TLX101-Tx (¹³¹I-iodofalan) in Telix’s pivotal IPAX BrIGHT trial1, marking the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma, an aggressive form of brain cancer.

The patient was dosed at Austin Health in Melbourne, Australia, under the supervision of Professor Hui Gan. IPAX BrIGHT is assessing the safety and efficacy of TLX101-Tx in combination with chemotherapy (lomustine), compared to chemotherapy alone. The global, multicenter, open-label study will enroll patients with radiographically confirmed recurrent glioblastoma at first recurrence.

Telix’s commitment to advancing care for patients with glioblastoma is driven by the significant unmet need in this space. In the past 25 years, only two drugs have been approved by the United States Food and Drug Administration (FDA) for glioblastoma2, and no standard treatment currently exists for recurrent disease. Patients therefore face limited treatment options after initial therapy. TLX101-Tx offers a novel approach by targeting the L-type amino acid transporter 1 (LAT1), a transporter that enables the radiopharmaceutical to cross the blood-brain barrier and delivers therapy directly to the tumor.

IPAX BrIGHT expands upon promising data from earlier trials in the recurrent glioblastoma setting, including IPAX-13, which reported a median overall survival (OS) of 13 months from the initiation of treatment with TLX101-Tx, or 23 months from initial diagnosis4. Preliminary results from the IPAX-Linz investigator-initiated trial of TLX101-Tx were consistent and confirmatory to IPAX-1, with a median OS of 12.4 months from initiation of treatment and 32.2 months from initial diagnosis5. Beyond the clinical trial setting, an early access program for TLX101-Tx in Europe has dosed 18 patients at first recurrence or later, further establishing the clinical utility of TLX101-Tx.

Professor Gan, Director of Cancer Clinical Trials at Austin Health, said, “Based on the prior safety profile and early efficacy data for TLX101-Tx in the IPAX-1 and IPAX-Linz studies, I am pleased to continue to explore this therapeutic modality in the first radiopharmaceutical pivotal trial in recurrent glioblastoma, where there are currently few effective treatment options.”

Dr. David N. Cade, Group Chief Medical Officer, Telix, added, “Through the IPAX BrIGHT trial, we aim to offer a new option for patients affected by glioblastoma. This registration-enabling study represents a major step forward in our mission to improve therapeutic options in neuro-oncology. With very limited innovation in treatment in recent decades, TLX101-Tx has the potential to become a first-in-class therapy that meaningfully improves patient outcomes.”

The IPAX BrIGHT study has received regulatory approval in Australia, Austria, Belgium and the Netherlands with approval being sought in additional jurisdictions. Telix’s investigational PET6 imaging agent for glioma, TLX101-Px (floretyrosine F 18) will be used for patient selection in IPAX BrIGHT, as well as assessing metabolic tumor response according to PET RANO 1.07.

About TLX101-Tx

TLX101-Tx (131I-iodofalan) is a systemically administered radiopharmaceutical therapy that targets L-type amino acid transporter 1 (LAT1), which is typically over-expressed in glioblastoma. TLX101-Tx utilizes a small molecule approach due to the need to cross the blood brain barrier, the normal protective barrier that prevents many potential drug candidates entering the brain. In addition to the IPAX-1 and IPAX-Linz studies, TLX101-Tx is also under investigation in the IPAX-2 Phase 1 study in combination with post-surgical standard of care treatment in patients with newly diagnosed glioblastoma8. TLX101-Tx has received orphan drug designation in the U.S. and Europe for the treatment of glioma. TLX101-Tx and TLX101-Px have not received a marketing authorization in any jurisdiction.

About glioblastoma  

Glioblastoma (GBM), is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.9. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients10, with an expected survival duration of 12-15 months from diagnosis11.

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 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 , and .

Telix Investor Relations (Global)



Ms. Kyahn Williamson

SVP Investor Relations and

Corporate Communications





Telix Investor Relations (U.S.)  



Ms. Annie Kasparian  

Director Investor Relations and

Corporate Communications  

 
Telix Investor Relations (Australia)



Ms. Charlene Jaw

Associate Director Investor

Relations

   

Media Contact

Eliza Schleifstein

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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, including TLX101-Px and TLX250-Px, 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 ClinicalTrials.gov ID: .

2 Temozolomide approved in 2005 and Bevacizumab in 2009.

3 ClinicalTrials.gov ID: .

4 Pichler et al. Neurooncol Adv. 2024.

5 Telix ASX disclosure April 16, 2025. Date presented by Professor Josef Pichler at the Nuclear Medicine and Neurooncology (NMN) Symposium in Vienna (Austria), May 2025.

6 Positron emission tomography.

7 Response Assessment in Neurooncology practice guidelines for the clinical use of PET imaging in gliomas.

8 ClinicalTrials.gov ID: .

9 Ostrom 2022, CBTRUS (Central Brain Tumor Registry of the United States) Statistical Report.

10 Park et al. Journal of Clinical Oncology. 2010.

11 Ostrom et al. Neuro Oncol. 2018.



EN
14/04/2026

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