{"id":42349,"date":"2026-03-15T21:35:57","date_gmt":"2026-03-15T21:35:57","guid":{"rendered":"https:\/\/allonlinebanglanewspapers.com\/news\/telix-resubmits-nda-to-u-s-fda-for-tlx101-px-pixclara-brain-cancer-imaging-candidate\/"},"modified":"2026-03-15T21:35:57","modified_gmt":"2026-03-15T21:35:57","slug":"telix-resubmits-nda-to-u-s-fda-for-tlx101-px-pixclara-brain-cancer-imaging-candidate","status":"publish","type":"post","link":"https:\/\/allonlinebanglanewspapers.com\/news\/telix-resubmits-nda-to-u-s-fda-for-tlx101-px-pixclara-brain-cancer-imaging-candidate\/","title":{"rendered":"Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara\u00ae) Brain Cancer Imaging Candidate"},"content":{"rendered":"
\n

MELBOURNE, Australia and INDIANAPOLIS, March 16, 2026 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, \u201cTelix\u201d) today announces the resubmission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-Px, (Pixclara\u00ae1<\/sup>, Floretyrosine F\u00a018 or 18<\/sup>F-FET), an investigational PET2<\/sup> imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients.<\/p>\n

Telix has resubmitted the NDA with the additional data requested by the FDA. The Company believes, based on the Type A meeting and ongoing consultation with the FDA, that the additional data and statistical analysis, along with the primary data set provided in the original submission, appropriately addresses the Complete Response Letter3<\/sup>.<\/p>\n

Given the potential to address significant unmet medical need, TLX101-Px has been granted Orphan Drug4<\/sup> and Fast Track5<\/sup> designations by the FDA. PET imaging with 18<\/sup>F-FET is already included in international clinical practice guidelines for the imaging of gliomas6<\/sup>, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.<\/p>\n

Dr. David N. Cade, Telix Group Chief Medical Officer, said, \u201cWe appreciate the FDA\u2019s recognition of the critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting. Our resubmission is supported by an extensive and compelling data set \u2013 particularly so for an orphan indication. We are grateful to our global clinical collaborators, who share our commitment to ensuring patients in the U.S. can benefit from this important patient management tool.\u201d<\/p>\n

Maggie Haynes, Executive Director, Head for the Cure Foundation, added: \u201cOur community is encouraged by the FDA\u2019s ongoing engagement and guidance to the sponsor and support for the Expanded Access Program for TLX101-Px. We are hopeful of an expedited review, so this important and proven imaging option can become available to those who urgently need it.\u201d<\/p>\n

About TLX101-Px<\/strong><\/p>\n

TLX101-Px is a PET imaging agent, which has been granted fast track and orphan drug designations by the FDA as an imaging agent for the characterization of recurrent or progressive glioma from treatment related changes. TLX101-Px targets membrane transport proteins known as LAT1 and LAT27<\/sup>. This enables TLX101-Px to be potentially utilized as a companion diagnostic agent to TLX101-Tx (iodofalan\u00a0131<\/sup>I), Telix\u2019s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in the pivotal IPAX-BrIGHT study8<\/sup>.\u00a0<\/p>\n

About gliomas in the U.S. <\/strong><\/p>\n

Gliomas are very diffusely infiltrative tumors that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) neoplasm that originates from glial cells, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors9<\/sup>. In the U.S., there are six cases of gliomas diagnosed per 100,000 people every year10<\/sup>. 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.11<\/sup>.\u00a0The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients12<\/sup>, with an expected survival duration of 12-15 months from diagnosis13<\/sup>.\u00a0<\/p>\n

About <\/strong>Telix Pharmaceuticals Limited <\/strong><\/p>\n

Telix is a global biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies, with the goal to address significant unmet medical needs in oncology and rare diseases. With international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan, Telix is headquartered in Melbourne, Australia. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).<\/p>\n

Illuccix\u00ae (kit for the preparation of gallium-68 (68<\/sup>Ga) gozetotide injection), Telix\u2019s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix\u00ae (kit for the preparation of gallium-68 (68<\/sup>Ga) gozetotide injection) has been approved by the U.S. FDA14<\/sup>. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction.<\/p>\n

Visit www.telixpharma.com<\/a> 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<\/a>, X<\/a> and Facebook<\/a>.<\/p>\n

Media Contact<\/strong><\/p>\n

Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com<\/a><\/p>\n

This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. <\/em><\/p>\n

Legal Notices<\/p>\n

Cautionary Statement Regarding Forward-Looking Statements.\u00a0 <\/em><\/p>\n

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.<\/em><\/p>\n

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. \u202fTo 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.<\/em><\/p>\n

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 \u201cmay\u201d, \u201cexpect\u201d, \u201cintend\u201d, \u201cplan\u201d, \u201cestimate\u201d, \u201canticipate\u201d, \u201cbelieve\u201d, \u201coutlook\u201d, \u201cforecast\u201d and \u201cguidance\u201d, 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\u2019s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix\u2019s 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\u2019s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix\u2019s preclinical and clinical trials, and Telix\u2019s research and development programs; Telix\u2019s 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\u2019s product candidates, including the planned NDA resubmission for TLX101-Px and the planned BLA resubmission for TLX250-Px, manufacturing activities and product marketing activities; Telix\u2019s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix\u2019s product candidates, if or when they have been approved; Telix\u2019s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix\u2019s expenses, future revenues and capital requirements; Telix\u2019s financial performance; developments relating to Telix\u2019s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix\u2019s business; and the pricing and reimbursement of Telix\u2019s product candidates, if and after they have been approved. Telix\u2019s 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.<\/em><\/p>\n

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 \u00ae or \u2122 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.<\/em><\/p>\n

\u00a92026 Telix Pharmaceuticals Limited. All rights reserved.<\/em><\/p>\n

1<\/sup> Brand name subject to final regulatory approval.
2<\/sup> Positron emission tomography.
3<\/sup> Telix ASX disclosure April 28, 2025.
4<\/sup> Telix ASX disclosure October 6, 2020.
5<\/sup> Telix ASX disclosure April 16, 2024. Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. More: https:\/\/www.fda.gov\/patients\/fast-track-breakthrough-therapy-accelerated-approval-priority-review\/fast-track<\/a>
6<\/sup> Galldiks et al.\u00a0Lancet Oncol.\u00a0<\/em>2025 (Joint guidelines from the European Association of Nuclear Medicine (EANM), European Association of Neuro-Oncology (EANO), Society of Nuclear Medicine and Molecular Imaging (SNMMI), Response Assessment in Neuro-Oncology (RANO), The European Society for Pediatric Oncology and The Response Assessment in Pediatric Neuro-Oncology for the characterization of recurrence in glioma patients); National Comprehensive Cancer Network\u00ae (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines\u00ae) for Central Nervous System Cancers V1.2025.
7<\/sup> L-type amino acid transporters 1 and 2.
8<\/sup> ClinicalTrials.gov ID:\u00a0NCT07100730<\/a>.
9<\/sup> Goodenberger et al. Cancer Genet.<\/em> 2012.
10<\/sup> Mesfin et al. StatP<\/em>earls.<\/em> 2024.
11<\/sup> Ostrom 2022, CBTRUS (Central Brain Tumor Registry of the United States) Statistical Report.
12<\/sup> Park et al.\u00a0Journal of Clinical Oncology.<\/em>\u00a02010.
13<\/sup> Ostrom et al.\u00a0Neuro Oncol.<\/em>\u00a02018.
14<\/sup> Telix ASX disclosure March 21, 2025.<\/p>\n

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