Latest news with #Gozellix®
Yahoo
29-04-2025
- Business
- Yahoo
ARTMS Drug Master File for Gallium Production Technology Referenced with Telix's Gozellix®
BURNABY, British Columbia, April 01, 2025 (GLOBE NEWSWIRE) -- Telix ARTMS, Inc. (ARTMS), a global leader in radioisotope production technologies, is pleased to announce that the drug master file (DMF)1 for gallium-68 production using its QUANTM Irradiation System® (QIS®) cyclotron technology has been referenced for the first time with a United States (U.S.) Food and Drug Administration (FDA) approved product, with Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection). This approval will enable radiopharmacies and hospitals using ARTMS' QIS® cyclotron technology and associated targets to produce multi-Curies of 68Ga for use with Gozellix®. The expanded distribution radius and increased dose production capacity, compared to existing gallium-based PET tracers, will facilitate broader and more equitable access. In addition, use of ARTMS' technology is being expanded internationally where regulatory submissions are in preparation. Pharmaceutical companies will be able to reference ARTMS' standardized isotope production technology with their approved drugs, helping to localize and simplify manufacturing. Chad Watkins, General Manager ARTMS and Isotope Strategy, Telix, said, 'This DMF reference represents a significant milestone for ARTMS, our partners and customers. The combination of these innovative technologies reflects Telix's commitment to working in partnership to reach more patients with 68Ga-PSMA-11, where and when they need it.' The QIS® forms part of ARTMS' 'turnkey' solution for customers that encompasses in-house manufactured targets and chemistry processing of isotopes, as well as DMF preparation and filing support. This makes large scale isotope production for hospitals and radiopharmaceutical distributors with cyclotrons significantly more attainable than with other existing technologies. ARTMS will continue to support the high efficiency, large-scale and cost-effective production of commercially important medical isotopes such as zirconium-89 (89Zr), gallium-68 (68Ga), technetium‐99m (99mTc) and copper-64 (64Cu), and will continue to partner with additional radiopharmaceutical companies to ensure that these critical isotopes are available on demand for patients. In addition, ARTMS' portfolio of advanced cyclotron technologies has application for Telix and select partners in the production of future commercially important alpha-emitting, therapeutic isotopes, including actinium-225 (225Ac) and astatine-211 (211At). For further information please contact: Chad Watkins Telix Pharmaceuticals LimitedGeneral Manager of ARTMS & Isotope StrategyEmail: Kevin ReimerTelix ARTMS, Global Sales and MarketingEmail: About Telix ARTMS, Inc. Based in Burnaby, British Columbia, Canada, Telix ARTMS, Inc. (ARTMS) is the global leader in the development of novel technologies and products which enable the high-quality and high-yield production of the world's most-used diagnostic imaging isotopes. ARTMS' flagship product, the QUANTM Irradiation System® (QIS®), enables decentralized, cost-effective, large-scale production of important medical isotopes such as gallium-68 (68Ga), zirconium-89 (89Zr), technetium‐99m (99mTc) and copper-64 (64Cu) using pharmaceutical distributor and hospital-based medical cyclotrons, empowering users to control their supply chain. ARTMS was acquired by Telix Pharmaceuticals in April 20242. For more information on QIS® and ARTMS, please follow us on X @ARTMS_TLX and LinkedIn and visit 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). Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA3. 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 Telix 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 A DMF is a submission to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.2 Telix ASX disclosure 11 April 2024.3 Telix ASX disclosure 21 March in to access your portfolio
Yahoo
09-04-2025
- Business
- Yahoo
Cardinal Health (NYSE:CAH) Selected By Telix For U.S. Launch Of Gozellix Imaging Agent
Cardinal Health has been selected as a distributor for Telix Pharmaceuticals' Gozellix®, an important development for the company, particularly in the U.S. market. Over the last quarter, Cardinal Health's stock moved 2%, a performance slightly better than the broader market's decline amid market volatility and tariff concerns. The company's partnership with Telix, combined with strategic board appointments of healthcare and tech experts, might have offered some resilience against broader market pressures. The cash dividend reaffirmation and share repurchase updates likely further bolstered investor confidence in otherwise turbulent market conditions. Cardinal Health has 1 risk we think you should know about. The best AI stocks today may lie beyond giants like Nvidia and Microsoft. Find the next big opportunity with these 24 smaller AI-focused companies with strong growth potential through early-stage innovation in machine learning, automation, and data intelligence that could fund your retirement. Cardinal Health's recent selection as a distributor for Telix Pharmaceuticals' Gozellix® could positively affect the company's trajectory, supporting the narrative of expanding key therapeutic offerings through strategic partnerships. Over a five-year period, Cardinal Health's total shareholder return was 183.89%, reflecting substantial growth. This performance aligns with the strategy outlined, despite short-term challenges due to integration costs and changing trade policies. In the more recent one-year period, Cardinal Health's returns outpaced the broader US market, which experienced a 3.8% decline. This outperformance may highlight investor confidence in the company's ability to leverage strategic acquisitions and focus on higher-margin business areas. The news regarding the Gozellix® distribution could influence revenue and earnings forecasts positively, enhancing existing growth expectations. Analysts project revenue growth of 6.6% annually for the next three years, with earnings reaching US$1.9 billion by April 2028. Such partnerships potentially support these forecasts, reinforcing the company's growth initiatives. Regarding the current market valuation, Cardinal Health's share price stands at US$137.13, slightly below the consensus analyst price target of US$141.87, only 3.3% higher. This marginal difference suggests that the market may view the stock as fairly valued, underscoring the importance of investor sentiment in light of recent developments. The analysis detailed in our Cardinal Health valuation report hints at an deflated share price compared to its estimated value. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NYSE:CAH. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Yahoo
08-04-2025
- Business
- Yahoo
Telix Announces Cardinal Health for Gozellix Commercial Distribution
MELBOURNE, Australia and INDIANAPOLIS, April 08, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that it has selected Cardinal Health, Inc. (NYSE: CAH, Cardinal Health) as one of its commercial radiopharmaceutical distributors to supply finished unit doses of Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix's next-generation PSMA-PET imaging1 agent for prostate cancer in the United States (U.S.). Following recent U.S. Food and Drug Administration (FDA) approval2, and in preparation for commercial launch in H1 2025, Telix has contracted with Cardinal Health to enable availability across a wide range of U.S. locations. To support the rollout, Cardinal Health has deployed Telix's ARTMS QUANTM Irradiation System® (QIS®) cyclotron technology, enabling standardized, high-efficiency and cost-effective production of cyclotron-produced gallium-68 for use with Gozellix®. These installations will facilitate multi-Curie local production of gallium-68. Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, said, 'Cardinal Health is a highly valued radiopharmacy distributor and its broad geographic reach and excellence in service delivery has been a key factor in the commercial success of Illuccix®. We are pleased to be building upon our successful relationship to bring the accuracy and clinical utility of gallium-based imaging to even more patients across the country with Gozellix®.' Mike Pintek, President of Cardinal Health Nuclear & Precision Health Solutions, added, 'We are pleased to continue to build on our relationship with Telix, which now includes the distribution of Illuccix®, Zircaix®3 and Gozellix®. The combination of our extensive commercial distribution structure and the innovative ARTMS production technology enables us to broaden patient reach and scheduling flexibility for gallium-based PSMA imaging. We look forward to bringing this novel precision medicine diagnostic to patients and their healthcare providers.' Cardinal Health will operate as a strategic radiopharmacy distributor for Gozellix alongside Telix's in-house radiopharmacy network. IMPORTANT SAFETY INFORMATIONWARNINGS AND PRECAUTIONS Risk for MisinterpretationImage interpretation errors can occur with GOZELLIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. Imaging Prior to Initial Definitive or Suspected Recurrence TherapyThe performance of GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of GOZELLIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Radiation RisksGallium Ga-68 gozetotide contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration. Hypersensitivity Reactions to SulfitesAscorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. ADVERSE REACTIONSThe safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%. DRUG INTERACTIONSAndrogen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established. Please note that this information is not see the Full Prescribing Information here. You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at or call 1-800-FDA-1088. You may also report adverse reactions to Telix Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@ 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 U.S. FDA4, by the Australian Therapeutic Goods Administration (TGA)5, by Health Canada6, by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)7, by the Brazilian Health Regulatory Agency (ANVISA)8, and in multiple countries within the European Economic Area (EEA)9 following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM10. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA11. 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. 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 Imaging of prostate-specific membrane antigen with positron emission tomography. 2 Telix ASX disclosure 21 March 2025.3 Subject to regulatory approval, Telix media release 17 September 2024.4 Telix ASX disclosure 20 December 2021.5 Telix ASX disclosure 2 November 2021.6 Telix ASX disclosure 14 October 2022.7 Telix ASX disclosure 13 February 2025.8 Telix ASX disclosure 18 March 2025.9 Denmark, Ireland, Luxembourg, Malta, the Netherlands and Norway at time of release.10 Telix ASX disclosure 17 January 2025.11 Telix ASX disclosure 21 March in to access your portfolio
Yahoo
21-03-2025
- Business
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FDA Approves New Prostate Cancer Imaging Agent Gozellix®
MELBOURNE, Australia and INDIANAPOLIS, March 21, 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 approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix's next-generation PSMA-PET imaging[1] agent for prostate cancer. Gozellix®, after radiolabeling with 68Ga, 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 recurrence based on elevated serum prostate-specific antigen (PSA) level. Gozellix® is a novel product which provides a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based imaging products. The ability to reliably deliver the product much further from its point of production means Gozellix® can reach PET cameras that are currently not served by any PSMA imaging providers, bringing the accuracy and clinical utility of gallium-based imaging to more patients across the U.S. The innovative formulation, which allows for more scalable production, also has the potential to enhance the efficiency, scheduling flexibility and throughput of scanning clinics. Gozellix® builds on the success of Telix's established PSMA-PET imaging agent, Illuccix®, and will be available alongside the first-generation product, providing choice for customers and patients based on their individual needs. In the U.S., the accuracy and sensitivity of PSMA-PET imaging means it has become the standard of care for prostate cancer imaging after initial diagnosis and biochemical recurrence[2]. However, only a relatively small fraction of the 3.4 million men living with prostate cancer in the U.S. have undergone this type of precision medicine scan[3],[4]. Telix believes Gozellix® will help to address these access issues, as it is expected to be eligible for full reimbursement[5] with reduced or no patient co-insurance, meaning it can reach more patients, particularly in underserved populations. Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, said, "Securing FDA approval for Gozellix is a major win for prostate cancer patients, who gain enhanced access to state-of-the-art 68Ga PSMA-PET imaging. Telix continues to invest in innovation across our portfolio, and Gozellix is a testament to this continuous improvement approach. With the launch of Gozellix, our team is excited to be bringing the new generation of prostate cancer scanning to more American men, delivered with the reliability, service and flexibility that customers have come to expect from Telix." IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Risk for Misinterpretation Image interpretation errors can occur with GOZELLIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. Imaging Prior to Initial Definitive or Suspected Recurrence Therapy The performance of GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of GOZELLIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Radiation Risks Gallium Ga-68 gozetotide contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration. Hypersensitivity Reactions to Sulfites Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. ADVERSE REACTIONS The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%. DRUG INTERACTIONS Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established. Please note that this information is not comprehensive. Please see the Full Prescribing Information here. You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at or call 1-800-FDA-1088. You may also report adverse reactions to Telix Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@ 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). Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix's first generation PSMA-PET imaging agent, has been approved by the U.S. FDA[6], by the Australian Therapeutic Goods Administration (TGA)[7], by Health Canada[8], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[9], by the Brazilian Health Regulatory Agency (ANVISA)[10], and in multiple countries within the European Economic Area (EEA)[11] following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM[12]. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA[13]. 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 authorized 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] Imaging of prostate-specific membrane antigen with positron emission tomography.[2] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2024.[3] NIH Common Cancer Sites — Cancer Stat Facts. Accessed May 2024.[4] Company analysis based on proprietary and public domain data.[5] Hospital Outpatient Prospective Payment System (OPPS) patients eligible for reimbursed PSMA-PET scanning.[6] Telix ASX disclosure 20 December 2021.[7] Telix ASX disclosure 2 November 2021[8] Telix ASX disclosure 14 October 2022.[9] Telix ASX disclosure 13 February 2025.[10] Telix ASX disclosure 18 March 2025.[11] Denmark, Luxembourg, Malta, the Netherlands and Norway at time of release.[12] Telix ASX disclosure 17 January 2025.[13] Telix ASX disclosure 21 March 2025. View original content to download multimedia: SOURCE Telix Pharmaceuticals Limited Sign in to access your portfolio
