Latest news with #TLX250-CDx
Yahoo
5 days ago
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Telix Manufacturing Solutions (TMS) Established in Yokohama, Japan
MELBOURNE, Australia and KYOTO, Japan, June 4, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix", "the Company") today announces that it has established Telix Manufacturing Solutions (TMS) in Yokohama, Japan. Telix's first cyclotron facility in the Asia Pacific region represents a significant milestone in the Company's global manufacturing strategy. TMS Yokohama will serve as a hub for commercial and clinical supply, and future research and development in the region. It expands Telix's global production network which includes in-house and partner facilities. Originally opened in 2018, the site comprises a cyclotron and multiple production hot cells and was designed and built by JFE Engineering Corporation (JFE) as the Contract Manufacturing Organization (CMO) for TLX250-CDx (Zircaix®[1], 89Zr-girentuximab) in Japan and China, including for the ZIRCON-CP study[2]. Taking over the lease and operational management of this facility will provide greater control over existing clinical supply with the possibility to expand production to other Telix investigational and future commercial products in the region, including Illuccix® (TLX591-CDx, 68Ga-PSMA-11) and Pixclara®1 (TLX101-CDx, 18F-floretyrosine) for Greater Tokyo, and TLX591 (177Lu rosopatamab tetraxetan) for the Asia Pacific region. Further, the Company plans to install Telix's ARTMS QUANTM Irradiation System® (QIS®) cyclotron technology, which it believes will facilitate standardized, high-efficiency and cost-effective production of commercially important medical isotopes. Darren Patti, Group Chief Operating Officer, Telix said, "We are pleased to announce Telix's first cyclotron facility in the Asia Pacific region, strategically located in Japan — the world's second-largest nuclear medicine market. TMS Yokohama enhances our capacity to meet growing demand in the region and supports our mission to provide patients with access to advanced diagnostic and therapeutic radiopharmaceuticals." 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, 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. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Telix's prostate imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the United States Food and Drug Administration (FDA)[1], by the Australian Therapeutic Goods Administration (TGA)[2], by Health Canada[3], by the Brazilian Health Regulatory Agency (ANVISA)[4], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[5], by the French National Agency for the Safety of Medicine and Health Products (ANSM)[6] and in multiple countries within the European Economic Area (EEA)[7] following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM[8]. TLX250-CDx, TLX101-CDx and TLX591 have not received a marketing authorization in any jurisdiction. Visit for further information about Telix, including details of the latest share price, ASX and 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 Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: [1] Telix ASX disclosure 20 December 2021. [2] Telix ASX disclosure 2 November 2021. [3] Telix ASX disclosure 14 October 2022. [4] Telix ASX disclosure 18 March 2025. [5] Telix ASX disclosure 13 February 2025. [6] Telix media release 29 April 2025. [7] Czech Republic, Denmark, Finland, Ireland, Luxembourg, Malta, the Netherlands, Norway and Sweden at time of release. [8] Telix ASX disclosure 17 January 2025. Legal Notices 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 and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol 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. ©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. View original content to download multimedia: SOURCE Telix Pharmaceuticals Limited Sign in to access your portfolio
Yahoo
19-05-2025
- Business
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Telix at ANZSNM Annual Scientific Meeting 2025
MELBOURNE, Australia, May 20, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix", "the Company") today announces a strong presence at the 55th Annual Scientific Meeting of the Australian and New Zealand Society of Nuclear Medicine (ANZSNM ASM 2025), to be held in Melbourne, Australia from 23–25 May 2025. Telix will feature prominently in the scientific program with eight oral and three poster presentations highlighting the Company's late-stage and next-generation programs. Demonstrating its commitment to development and education in theranostics, Telix presentations include: ProstACT Global Phase 3 study of TLX591 (177Lu-rosopatamab tetraxetan)[1], Telix's first-in-class PSMA[2] targeting radio antibody-drug conjugate (rADC) therapy candidate STARSTRUCK study of TLX250 (177Lu-girentuximab) in combination with peposertib[3] in patients with carbonic anhydrase IX (CAIX)-expressing solid tumors[4], and a preclinical evaluation of 225Ac-girentuximab in combination with DNA damage response inhibition Zolar study of TLX300-CDx (89Zr-olaratumab)[5], a theranostic approach in soft tissue sarcoma ZIRCON-CP study of TLX250-CDx (Zircaix®[6], 89Zr-girentuximab), Telix's kidney cancer PET[7] radiodiagnostic candidate in Chinese patients with indeterminate renal masses[8] TLX250-CDx early access in Australia and Italy highlighting clinical utility in clear cell renal cell carcinoma (ccRCC) D2, a first-in-class, dual-chelator theranostic that could enable the use of imaging-therapy radiometal pairs of different elements[9] Artificial intelligence (AI) enabled PSMA-PET/CT[10] lesion delineation for prostate cancer. Telix will also host a Breakfast Symposium showcasing real-world experience and impact on clinical decision making with TLX250-CDx, and clinical utility of PSMA-PET. Again we are pleased to support the Nurses' Workshop in collaboration with with the Prostate Cancer Foundation of Australia (PCFA), NeuroEndocrine Cancer Australia (NECA) and the Peter MacCallum Cancer Centre in Melbourne. Telix will be at booth #28, where visitors can learn more about Telix's extensive late-stage theranostic pipeline in urologic oncology (prostate, kidney and bladder), neuro-oncology (glioma), musculoskeletal oncology (sarcoma) and hematology, our associated medical technologies and AI innovations, and opportunities for collaboration. Details of ANZSNM ASM 2025 abstract presentations related to Telix programs are listed below and the full congress program can be accessed here. All times AEST. Saturday, 24 May 2025 Title: Preclinical evaluation of DNA damage response inhibitors and 225Ac-DOTA-girentuximab combination therapyPresenter: Zhipeng Cao, Olivia Newton-John Cancer Research InstituteTime: 11:00 AM – 12:30 PMSession: RPS Session including Shimadzu AwardLocation: Meeting Room 204 Title: D2 – Enabling a theranostic approach with 89Zr/177Lu in a single trifunctional ligand scaffoldPresenter: James Wood, The University of QueenslandTime: 11:00 AM – 12:30 PMLocation: Meeting Room 204Session: RPS Session including Shimadzu Award Sunday, 25 May 2025 Title: A preliminary study on nnUNet-based PSMA-PET/CT lesion segmentation models: toward clinically informed trainingPresenter: David Han, Telix PharmaceuticalsTime: 11:00 AM – 12:30 PMLocation: Meeting Room 204Session: Scientific Session: Oncology 3 Title: ZOLAR, an open-label, Phase 1 study to assess safety, tolerability, dosimetry, pharmacokinetics, and imaging properties of 89Zr-olaratumab (TLX300-CDx) in patients with soft tissue sarcomaPresenter: Corinne Letendre, Telix PharmaceuticalsTime: 11:00 AM – 12:30 PMLocation: Meeting Room 203Session: Scientific Session: Therapy / Phase 1 Trials Title: ProstACT Global, a multinational, multicenter, prospective, randomized, controlled, open-label, Phase 3 study of 177Lu -rosopatamab tetraxetan (TLX591) in combination with standard of care (SoC) versus SoC alone in patients with PSMA-positive metastatic castrate-resistant prostate cancer (mCRPC) after androgen receptor pathway inhibitor (ARPI) treatmentPresenter: Veronica Wong, Nepean HospitalTime: 11:00 AM – 12:30 PMLocation: Meeting Room 203Session: Scientific Session: Therapy / Phase 1 Trials Title: STARSTRUCK, a Phase 1b dose escalation/expansion study of the combination of 177Lu-girentuximab (TLX250) and peposertib in patients with carbonic anhydrase IX (CAIX)-expressing solid tumorsPresenter: Aviral Singh, GenesisCareTime: 11:00 AM – 12:30 PMLocation: Meeting Room 203Session: Scientific Session: Therapy / Phase 1 Trials Title: ZIRCON-CP, a confirmatory, open-label, single-arm, multicenter study to evaluate the safety, tolerability, and diagnostic performance of 89Zr-girentuximab (TLX250-CDx) to non-invasively detect ccRCC by PET/CT imaging in Chinese patients with indeterminate renal massesPresenter: Mary Jessel, Telix PharmaceuticalsTime: 2:00 PM - 3:30 PMLocation: Meeting Room 207Session: Scientific Session: Oncology Preclinical Title: Preliminary investigation of radiation exposure of pathology staff from urine samples containing traces of 177Lu-rosopatamab tetraxetan (TLX591)Presenter: Alessandra Malaroda, Nepean HospitalTime: 2:00 PM - 3:30 PMLocation: Meeting Room 204Session: Scientific Session: Oncology 4 Posters: Displayed throughout meeting Title: Non-invasive detection of Nectin-4 and TROP2 in bladder cancer via ImmunoPETPresenter: Peter Chandler, Telix Pharmaceuticals Title: Initial experience with 89Zr-girentuximab (TLX250-CDx)Presenter: Alexis Dalagiorgos, Jones Radiology Title: The emerging role of 89Zr-girentuximab (TLX250-CDx) PET/CT in the management of ccRCC: Early experience in three patientsPresenter: Fabrizia Gelardi, Università Vita-Salute San Raffaele, Milan (Italy) Breakfast Session and Nurses Workshop Telix-Hosted BreakfastLocation: Meeting Room 203Date and Time: Sunday, 25 May | 7:15 AM – 8:15 AMTopics and Presenters: Enhancing cancer care with precision radiopharmaceuticals: Expanded access for renal cancers – Sze Ting Lee, Austin Health Early diagnosis with PSMA-PET in prostate cancer – Michael Kitchener, Jones Radiology Nurses WorkshopLocation: Meeting Room 205Date and Time: Saturday, 24 May | 12:30 PM – 1:30 PMTopics and Presenters: Interpreting liver function tests – Emma Boehm, Peter MacCallum Cancer Centre Gallium-68 PET, FDG PET and other imaging modalities – Aaron Wong, Peter MacCallum Cancer Centre Managing toxicities in theranostics – Gabby Cehic AM, SA Health Radiation safety during radiopharmaceutical therapy – Daniel Badger, SA Health 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, 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. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. 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 by the United States Food and Drug Administration (FDA)[11], by the Australian Therapeutic Goods Administration (TGA)[12], by Health Canada[13], by the Brazilian Health Regulatory Agency (ANVISA)[14], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[15], by the French National Agency for the Safety of Medicine and Health Products (ANSM)[16] and in multiple countries within the European Economic Area (EEA)[17] following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM[18]. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA[19]. TLX591, TLX250, TLX250-CDx and TLX300-CDx have not received a marketing authorization in any jurisdiction and are for investigational use only. Visit for further information about Telix, including details of the latest share price, ASX and 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 Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: Legal Notices 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 and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol 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. ©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. [1] ID: NCT06520345 [2] Prostate-specific membrane antigen. [3] A Merck KGaA, Darmstadt, Germany (Merck) DNA-dependent protein kinase (DNA-PK) inhibitor candidate (M3814). [4] ID: NCT05868174 [5] ID: NCT06537596 [6] Brand name subject to final regulatory approval. [7] Positron emission tomography. [8] ID: NCT06750419 [9] Wood et al. Chem. Sci., 2024. [10] Imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography. [11] Telix ASX disclosure 20 December 2021. [12] Telix ASX disclosure 2 November 2021 [13] Telix ASX disclosure 14 October 2022. [14] Telix ASX disclosure 18 March 2025. [15] Telix ASX disclosure 13 February 2025. [16] Telix media release 29 April 2025. [17] Czech Republic, Denmark, Finland, Ireland, Luxembourg, Malta, the Netherlands, Norway and Sweden at time of release. [18] Telix ASX disclosure 17 January 2025. [19] Telix ASX disclosure 21 March 2025. View original content to download multimedia: SOURCE Telix Pharmaceuticals Limited Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
26-02-2025
- Business
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FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review
MELBOURNE, Australia, Feb. 26, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET[1] imaging agent TLX250-CDx (Zircaix®[2], 89Zr-DFO-girentuximab), granted a Priority Review and provided a PDUFA[3] date of 27 August 2025, paving the way for a U.S. commercial launch in 2025. If approved, TLX250-CDx will become the first commercially available imaging agent to accurately and non-invasively diagnose and characterize clear cell renal cell carcinoma (ccRCC), the most common and one of the most aggressive sub-types of kidney cancer. It works by specifically binding to carbonic anhydrase IX (CAIX), a validated target protein expressed on 95% of ccRCC cells to produce images with high tumor-to-background ratio and high intra- and inter-reader consistency. The BLA is based on Telix's successful global Phase 3 ZIRCON[4] study, which demonstrated a sensitivity of 86%, specificity of 87% and a positive predictive value (PPV) of 93% for ccRCC, including in very small, difficult-to-detect lesions[5]. The results of this study were published in The Lancet Oncology in September 2024, in a peer-reviewed manuscript by Professor Brian Shuch (University of California, Los Angeles, UCLA) and colleagues[6]. The paper outlines the critical unmet need for a new, non-invasive technique that can accurately detect and differentiate ccRCC from other renal masses in patients and concluded that TLX250-CDx meets this need and 'has the potential to be practice changing.' Kevin Richardson, Chief Executive Officer, Precision Medicine, said, "We are delighted that the FDA has accepted this BLA as it moves us one step closer to bringing our breakthrough product to patients. We are aiming to revolutionize the management of kidney cancer, just as PSMA-PET/CT[7] scanning has changed the management of prostate cancer. By providing a more definitive clinical diagnosis for renal masses, we believe that Zircaix[2] will help physicians make more timely and confident patient management decisions and more quickly provide patients with a clear understanding of their disease and treatment options. Building further on Telix's successful urology franchise, we are preparing to bring this powerful precision medicine product to market in 2025[8]." About TLX250-CDx TLX250-CDx (Zircaix®[2]) is an investigational PET agent that is under development for the diagnosis and characterization of ccRCC. Telix's pivotal Phase 3 ZIRCON trial evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% PPV for ccRCC across three independent radiology readers[5]. Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation. As part of Telix's commitment to access to medicine, the Company operates an expanded access program (EAP) in the U.S.[9], named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx outside of a clinical trial, to patients for whom there are no comparable or satisfactory alternate options. TLX250-CDx has not received a marketing authorization in any jurisdiction and is for investigational use only. 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, 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. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. 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 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 Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices 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 and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol 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 commercialisation 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; 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. ©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. [1] Positron emission tomography.[2] Brand name subject to final regulatory approval. [3] Prescription Drug User Fee Act. [4] Zirconium in Renal Cancer Oncology, ID: NCT03849118.[5] Telix ASX disclosures 7 November 2022.[6] Shuch et al. Lancet Oncology. 2024.[7] Imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography.[8] Subject to regulatory approval.[9] ID: NCT06090331. 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Yahoo
26-02-2025
- Business
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FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review
MELBOURNE, Australia and INDIANAPOLIS, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET1 imaging agent TLX250-CDx (Zircaix®2, 89Zr-DFO-girentuximab), granted a Priority Review and provided a PDUFA3 date of 27 August 2025, paving the way for a U.S. commercial launch in 2025. If approved, TLX250-CDx will become the first commercially available imaging agent to accurately and non-invasively diagnose and characterize clear cell renal cell carcinoma (ccRCC), the most common and one of the most aggressive sub-types of kidney cancer. It works by specifically binding to carbonic anhydrase IX (CAIX), a validated target protein expressed on 95% of ccRCC cells to produce images with high tumor-to-background ratio and high intra- and inter-reader consistency. The BLA is based on Telix's successful global Phase 3 ZIRCON4 study, which demonstrated a sensitivity of 86%, specificity of 87% and a positive predictive value (PPV) of 93% for ccRCC, including in very small, difficult-to-detect lesions5. The results of this study were published in The Lancet Oncology in September 2024, in a peer-reviewed manuscript by Professor Brian Shuch (University of California, Los Angeles, UCLA) and colleagues6. The paper outlines the critical unmet need for a new, non-invasive technique that can accurately detect and differentiate ccRCC from other renal masses in patients and concluded that TLX250-CDx meets this need and 'has the potential to be practice changing.' Kevin Richardson, Chief Executive Officer, Precision Medicine, said, 'We are delighted that the FDA has accepted this BLA as it moves us one step closer to bringing our breakthrough product to patients. We are aiming to revolutionize the management of kidney cancer, just as PSMA-PET/CT7 scanning has changed the management of prostate cancer. By providing a more definitive clinical diagnosis for renal masses, we believe that Zircaix2 will help physicians make more timely and confident patient management decisions and more quickly provide patients with a clear understanding of their disease and treatment options. Building further on Telix's successful urology franchise, we are preparing to bring this powerful precision medicine product to market in 20258.' About TLX250-CDx TLX250-CDx (Zircaix®2) is an investigational PET agent that is under development for the diagnosis and characterization of ccRCC. Telix's pivotal Phase 3 ZIRCON trial evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% PPV for ccRCC across three independent radiology readers5. Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation. As part of Telix's commitment to access to medicine, the Company operates an expanded access program (EAP) in the U.S.9, named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx outside of a clinical trial, to patients for whom there are no comparable or satisfactory alternate options. TLX250-CDx has not received a marketing authorization in any jurisdiction and is for investigational use only. 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, 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. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. 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 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 Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices 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 and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol 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 commercialisation 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; 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. ©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. 1 Positron emission tomography.2 Brand name subject to final regulatory approval. 3 Prescription Drug User Fee Act. 4 Zirconium in Renal Cancer Oncology, ID: NCT03849118.5 Telix ASX disclosures 7 November 2022.6 Shuch et al. Lancet Oncology. 2024.7 Imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography.8 Subject to regulatory approval.9 ID: NCT06090331.
