MELBOURNE, Australia and INDIANAPOLIS, Dec. 30, 2024 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX ; Nasdaq: TLX , a Telix Company) today announces that it has submitted its Biologics License Application (BLA) to the United Kingdom US Food and Drug Administration (FDA) for TLX250-CDx (Zircaix®1, 89Zr-girentuximab) kidney cancer imaging2.
TLX250-CDx is an investigational PET3 drug for the non-invasive diagnosis and characterization of clear cell renal cell carcinoma (ccRCC), the most common and most aggressive form of kidney cancer. If approved, TLX250-CDx will be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the US, further building on Telix’s successful urology imaging franchise.
The FDA is expected to notify the PDUFA4 target date after a 60-day administrative review of the application.
Kevin Richardson, Chief Executive Officer, Precision Medicine at Telix, stated, We are pleased to advance the BLA for TLX250-CDx, which has received Breakthrough designation, and may therefore qualify for priority review. Telix continues to target a full commercial launch in the US in 2025, addressing the large unmet medical need of patients with suspected ccRCC.
About the TLX250-CDx
TLX250-CDx (Zircaix ®1) is an investigational PET agent in development for the diagnosis and characterization of ccRCC. Telix’s pivotal phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118) evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including demonstrating 86% sensitivity and 87% specificity and a 93% positive predictive value for ccRCC across three independent radiology readers5. Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the pure cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. The confidence intervals exceeded the expectations of all three readers, showing evidence of high accuracy and consistency of interpretation.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of diagnostic and therapeutic radiopharmaceuticals and related medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland) and Japan. Telix develops a portfolio of clinical and commercial products aimed at addressing 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).
Telix’s flagship imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and sold under the brand name Illuccix®), has been approved by the US Food and Drug Administration (FDA)6, by Australian Therapeutic Commodities Authority (TGA)7, and Health Canada8. No other Telix product has been approved for marketing in any jurisdiction.
Please visit www.telixpharma.com for further information on Telix, including details of the latest share price, ASX announcements, investor and analyst presentations, press releases, event details and other publications that may be of interest. You can also follow Telix on Xu and LinkedIn.
Telix Investor Relations
Mrs Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
This announcement has been approved by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
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You should read this announcement together with our risk factors, as disclosed in our most recent reports filed with the Australian Securities Exchange (ASX), the US Securities and Exchange Commission (SEC), including our registration statement on Form 20-F filed to the SEC, or on our website.
The information contained in this announcement is not intended to constitute an offer to subscribe for, solicitation of, or recommendation with respect to the securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this publication are subject to change without notice. To the fullest extent permitted by law, Telix disclaims any duty or obligation to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as defined below), whether as a result of new information, future developments, changes in expectations or assumptions or otherwise. No representation or warranty, express or implied, is made with respect to the accuracy or completeness of the information contained or the opinions expressed during this publication.
This announcement may contain forward-looking statements, including within the meaning of the US Private Securities Litigation Reform Act of 1995, relating to expected future events, financial results, plans, strategies or business developments. Forward-looking statements generally can be identified by the use of words such as may, expect, intend, plan, estimate, predict, believe, outlook, forecast and guidance, or by 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 future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. statements. Forward-looking statements are based on Telix’s good faith assumptions about 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. correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements regarding: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance, enroll and successfully complete product candidates into clinical studies, including multinational clinical trials; the timing or likelihood of regulatory submissions 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 are approved; Telix’s ability to obtain an adequate supply of raw materials at a reasonable cost for its products and product candidates; estimates of Telix’s costs, future revenues and capital requirements; Telix’s financial performance; developments regarding Telix’s competitors and the industry; and pricing and fees for Telix’s product candidates, if and after they are approved. Telix’s actual results, performance or achievements may differ materially from those expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.
©2024 Telix Pharmaceuticals Limited. The names and logos of Telix Pharmaceuticals ® , Illuccix ® and Zircaix ® 1 are trademarks of Telix Pharmaceuticals Limited and its subsidiaries “all rights reserved.
1 Brand name subject to final regulatory approval.
2 Telix ASX Release 31 July 2024 The FDA has requested additional data demonstrating adequate assurance of sterility during dispensing of TLX250-CDx in a radiopharmaceutical manufacturing environment.
3 Positron emission tomography.
4 Law on Benefits for Users of Prescription Medicines.
5 Shuch et al. Lancet Oncol. 2024 Telix ASX Reveals 7 Nov 2022
6 Telix ASX Announcement 20 December 2021
7 Telix ASX Disclosure 2 November 2021
8 Telix ASX Announcement 14 October 2022
Source: Telix Pharmaceuticals Limited
