Latest news with #TelixPharmaceuticalsLimited
Malaysian Reserve
18 hours ago
- Business
- Malaysian Reserve
Telix H1 2025 Results: Investor Webcast Notification
MELBOURNE, Australia and INDIANAPOLIS, July 30, 2025 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, 'Telix') today advises that it will release its financial results for the half-year ended 30 June 2025 on Thursday 21 August 2025. An investor webcast and conference call will be held at 9.30am AEST on Thursday 21 August 2025 (7.30pm EDT Wednesday 20 August 2025). Participants can register for the webcast at the following link: Participants can register for the teleconference here: 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. 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 LinkedIn, X and Facebook Telix Investor RelationsMs. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: Telix Investor Relations (U.S.) Annie Kasparian Telix Pharmaceuticals Limited Director Investor Relations and Corporate Communications Email: This announcement has been authorized for release by Telix Pharmaceuticals Limited's Company Secretary, Genevieve Ryan. 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.
Yahoo
19 hours ago
- Business
- Yahoo
Telix H1 2025 Results: Investor Webcast Notification
MELBOURNE, Australia and INDIANAPOLIS, July 30, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, 'Telix') today advises that it will release its financial results for the half-year ended 30 June 2025 on Thursday 21 August 2025. An investor webcast and conference call will be held at 9.30am AEST on Thursday 21 August 2025 (7.30pm EDT Wednesday 20 August 2025). Participants can register for the webcast at the following link: Participants can register for the teleconference here: 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. 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 LinkedIn, X and Facebook Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: Telix Investor Relations (U.S.) Annie Kasparian Telix Pharmaceuticals Limited Director Investor Relations and Corporate Communications Email: This announcement has been authorized for release by Telix Pharmaceuticals Limited's Company Secretary, Genevieve Ryan. 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.
Malaysian Reserve
09-07-2025
- Business
- Malaysian Reserve
Gozellix Receives Permanent HCPCS Code
MELBOURNE, Australia, July 9, 2025 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, 'Telix') today announces that its next-generation PSMA[1] PET[2] imaging agent, Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) code by the U.S. Centers for Medicare & Medicaid Services (CMS). Effective from 1 October 2025, CMS and commercial health insurers will recognise the HCPCS Level II code A9616 assigned for reimbursement of Gozellix. The assignment of the code is a significant milestone supporting provider billing and reimbursement for Gozellix, and a further step toward receiving Transitional Pass-Through (TPT) payment status. After radiolabelling with 68Ga, Gozellix is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected biochemical recurrence (BCR) based on elevated serum prostate-specific antigen (PSA) level. With its extended shelf-life and flexible production options, Gozellix overcomes many of the logistical barriers that have historically limited access to PSMA-PET imaging. Telix believes receiving a HCPCS code will support clinical adoption of Gozellix and expanded access to PSMA PET imaging. Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, said, 'Being granted a HCPCS code marks a significant step forward in Telix's mission to improve access to precision medicine imaging for prostate cancer patients across the United States, regardless of their location. It is also an important enabler for commercial scale-up and reimbursement of Gozellix in the U.S. as we bring our next-generation PSMA PET imaging agent to market.' 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. 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. FDA[3]. 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. [1] Prostate-specific membrane antigen. [2] Positron emission tomography. [3] Telix ASX disclosure 21 March 2025. Telix Investor RelationsMs. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: Telix Investor Relations (U.S.) Annie Kasparian Telix Pharmaceuticals Limited Director Investor Relations and Corporate Communications Email: This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. 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 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. Trademarks and Trade NamesAll 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.
Malaysian Reserve
13-06-2025
- Business
- Malaysian Reserve
Illuccix® Prostate Cancer PSMA-PET Imaging Agent Approved in Greece
MELBOURNE, Australia, June 13, 2025 /PRNewswire/ –Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, 'Telix', 'the Company') today announces that its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by the Greek EOF[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer – a broad clinical label. This approval enhances the options available to healthcare providers across Greece for PSMA-PET[3] imaging using a clinically-validated, gallium-based radiopharmaceutical. Illuccix, after radiolabelling with gallium-68, is indicated in Greece for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to primary curative therapy. Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy. Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated. PSMA-PET imaging represents a significant advancement in prostate cancer management, providing clinicians with more information than conventional imaging methods (bone scan, CT[4] scan) thereby offering a new standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines highlight the superior accuracy of PSMA-PET for the staging of primary disease and evaluation of BCR[5]. Illuccix PSMA-PET will help fulfil a critical unmet need by facilitating access to timely and effective diagnosis and patient selection for treatment with PSMA-targeted therapy. Access to PSMA-PET imaging in Greece remains extremely limited. During 2024, tracer and staff shortages meant that only 1,600 PSMA-PET examinations were conducted nationally, representing a small fraction of the 7,000 patients newly diagnosed each year. Illuccix's broad approval, supported by robust clinical data including the largest Ga-68-based PSMA data set from the VISION trial[6], will help address these challenges. Dr. Theodore Pipikos, Head of Nuclear Medicine and PET/CT at Hygeia Hospital, Athens, welcomed the decision, commenting, 'The approval of Illuccix marks a significant step forward in prostate cancer imaging for men in Greece. Given the structural barriers in our healthcare system, Illuccix provides healthcare practitioners with a widely accessible and much-needed tool to improve diagnostic accuracy.' Raphaël Ortiz, Chief Executive Officer, Telix International, added, 'The approval of Illuccix in Greece will support more widely available PSMA-PET imaging, and enable more healthcare providers and their patients to benefit from the convenience and flexibility of generator-produced gallium. This milestone reinforces Telix's ongoing commitment to advancing prostate cancer care and expanding access to innovative diagnostic and therapeutic radiopharmaceuticals across Europe'. Illuccix will be made available in Greece through Telix's distribution partner BIOKOSMOS S.A. a key radiopharmaceutical manufacturer in Greece with a comprehensive distribution network, which covers the full Greek Territory as well as Cyprus. Healthcare professionals in Greece interested in ordering Illuccix or learning more about availability can contact orders@ or call +30 22920 63900. Prostate Cancer in Greece Prostate cancer is the most common cancer for men in Greece with over 7,000 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (4,346 new cases) or lung cancer (6,357 new cases). Prostate cancer is the third most common cause of cancer death in men in Greece, with just over 1,900 men dying from their disease in 2022[7]. About Illuccix 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)[8], by the Australian Therapeutic Goods Administration (TGA)[9], by Health Canada[10], by the Brazilian Health Regulatory Agency (ANVISA)[11], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[12], by the French National Agency for the Safety of Medicine and Health Products (ANSM)[13], by the German Federal Institute for Drugs and Medical Devices (BfArM), and in multiple countries within the European Economic Area (EEA)[14] following a positive decentralized procedure (DCP) opinion by the German medical regulator[15]. 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. 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: 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. The 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] ΕΟΦ, Εθνικός Οργανισμός Φαρμάκων (National Organization for Medicines). [3] Imaging of prostate-specific membrane antigen with positron emission tomography. [4] Computed tomography. [5] EAU Guidelines. Edn. presented at the EAU Annual Congress Paris 2024. ISBN 978-94-92671-23-3.: Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. 2023: [6] ID: NCT03511664. VISION study sponsored by Endocyte, a Novartis company. Telix provided Illuccix (TLX591-CDx) for PSMA-PET imaging. [7] Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024. [8] Telix ASX disclosure 20 December 2021. [9] Telix ASX disclosure 2 November 2021. [10] Telix ASX disclosure 14 October 2022. [11] Telix ASX disclosure 18 March 2025. [12] Telix ASX disclosure 13 February 2025. [13] Telix media release 29 April 2025. [14] Czech Republic, Denmark, Finland, Greece, Ireland, Luxembourg, Malta, the Netherlands, Norway, Portugal and Sweden at time of release. [15] Telix ASX disclosure 17 January 2025. Logo – View original content:
Malaysian Reserve
04-06-2025
- Business
- Malaysian Reserve
Telix's Illuccix® PSMA-PET Imaging Agent Approved in Portugal
MELBOURNE, Australia, June 4, 2025 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, 'Telix', 'the Company') today announces that its prostate cancer PET[1] imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in Portugal by INFARMED[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enhances the options available to healthcare providers across Portugal for PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical. Illuccix, after radiolabelling with gallium-68, is indicated in Portugal for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to primary curative therapy. Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy. Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated. PSMA-PET imaging represents a significant advancement in prostate cancer management, largely replacing conventional imaging methods such as bone scans and CT[4] scans as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines recognise its superior accuracy in staging primary disease and assessing BCR[5]. Illuccix® PSMA-PET will help address an important clinical need by supporting timely and effective diagnosis, as well as identifying patients who may benefit from PSMA-targeted therapy. Illuccix's broad approval is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial[6]. Despite the proven benefits of PSMA-PET imaging, patients in Portugal have faced long wait times due to tracer shortages and infrastructure constraints. Dr. Fernando Abreu, Director of Nuclear Medicine at the Santa Maria Local Health Unit, commented, 'PSMA-PET imaging has significantly enhanced the accuracy and confidence in the detection and monitoring of prostate cancer. However, Portugal is currently facing a shortage of gallium-68 tracers, which has resulted in a national waiting list of up to six months. This delay has an impact on the timely diagnoses and treatments impacting patient care. The approval of Illuccix® in Portugal will be welcomed by physicians and patients as it allows hospitals and clinics to conduct PSMA-PET scans more efficiently, and with shorter wait times.' With its broad indication, Illuccix® is designed to support healthcare providers in delivering efficient and reliable imaging. The approval comes as demand for PSMA-PET continues to grow across Europe, reinforcing the need for solutions that fit within existing hospital workflows. Illuccix® will be distributed in Portugal by Sociedade Avanço, Unipessoal, LDA (Avanço), a specialist distributor of nuclear medicine, radiotherapy technologies and urology biopsy products. 'The approval of Illuccix® in Portugal marks an important milestone, providing healthcare professionals with access to a gallium-based PSMA-PET imaging agent supported by strong clinical validation. Our partnership with Avanço will help address the current shortages of gallium tracers and enable more efficient scanning processes. This collaboration reflects Telix's ongoing commitment to expanding access to high-quality prostate cancer imaging across Europe and reducing the barriers that currently delay diagnosis and treatment.' said Raphaël Ortiz, Chief Executive Officer, Telix International. Mr. Diogo Marcos, Managing Director of Avanço added: 'We are delighted to partner with Telix for the distribution of Illuccix® in Portugal. As the official distributor of the GalliaPharm®[7] generator, currently the only generator with marketing approval in the country, we are uniquely positioned to help address the national shortage of gallium-68. Our established distribution network ensures nationwide access, and our collaboration with Telix will enable us to support physicians in delivering timely and accurate PSMA-PET imaging.' Healthcare professionals in Portugal interested in ordering Illuccix® or learning more about availability can contact comercial@ or call (+351) 214 380 690. Prostate Cancer in Portugal Prostate cancer is the most common cancer in men in Portugal, with just over 7,500 new cases diagnosed annually, and a significantly higher incidence in men than either bowel (6,092 new cases) or lung cancer (4,253 new cases). Prostate cancer is also the third most common cause of cancer death in men, with just over 2,080 men dying from their disease in Portugal in 2022[8]. About Illuccix® 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)[9], by the Australian Therapeutic Goods Administration (TGA)[10], by Health Canada[11], by the Brazilian Health Regulatory Agency (ANVISA)[12], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[13], by the French National Agency for the Safety of Medicine and Health Products (ANSM)[14] and in multiple countries within the European Economic Area (EEA)[15] following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM[16]. 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). 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 Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: 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; 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. The 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] National Authority of Medicines and Health Products, I.P. [3] Imaging of prostate-specific membrane antigen with positron emission tomography. [4] Computed tomography. [5] European Association of Urology (EAU) Guidelines. Edn. presented at the EAU Annual Congress Paris 2024. ISBN 978-94-92671-23-3.: Prostate cancer: European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for diagnosis, treatment and follow-up. 2023: [6] ID: NCT03511664. VISION study sponsored by Endocyte, a Novartis company. Telix provided Illuccix (TLX591-CDx) for PSMA-PET imaging. [7] GalliaPharm® is a registered trademark of Eckert & Ziegler SE. [8] Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024. [9] Telix ASX disclosure 20 December 2021. [10] Telix ASX disclosure 2 November 2021. [11] Telix ASX disclosure 14 October 2022. [12] Telix ASX disclosure 18 March 2025. [13] Telix ASX disclosure 13 February 2025. [14] Telix media release 29 April 2025. [15] Czech Republic, Denmark, Finland, Ireland, Luxembourg, Malta, the Netherlands, Norway, Portugal and Sweden at time of release. [16] Telix ASX disclosure 17 January 2025. Logo – View original content:
