Latest news with #Illuccix®
Yahoo
6 days ago
- Business
- Yahoo
Telix Pharmaceuticals (ASX:TLX) Gains Portugal Approval for Illuccix in Prostate Cancer Detection
Telix Pharmaceuticals recently gained marketing authorization for its prostate cancer imaging agent, Illuccix®, in Portugal. This development enhances diagnostic options in a country where prostate cancer is prevalently diagnosed. Last week, the company's share price rose by 3%, a move that aligns with its recent regulatory success. Although the broader market remained steady over the same period, Telix's approval could provide additional support to its stock performance. The growth in Telix's share price complements the longer-term market trend, with broader market earnings expected to grow annually, positioning the company favorably. We've discovered 1 risk for Telix Pharmaceuticals that you should be aware of before investing here. We've found 20 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. Over the past five years, Telix Pharmaceuticals has delivered a tremendous total shareholder return of 1863.90%. In the past year, Telix's performance surpassed the Australian Biotechs industry, which saw a 10.2% decline, highlighting the company's robust and resilient market position. The recent marketing authorization for Illuccix® in Portugal is expected to bolster revenue streams, complementing the company's efforts to expand its presence across international markets. These developments align with revenue forecasts expecting annual growth of 19.5%, outpacing the broader Australian market's expected growth of 5.6% annually. Telix's earnings forecasts also suggest promising growth, projected to rise significantly at 33.2% per year, compared to the market's 11.7%. This is supported by the company's strategic approvals and existing product portfolio, contributing to upward earnings revisions. The current share price movement, slightly below the consensus analysts' price target of A$32.05, suggests that there may be potential for further share price appreciation as the company continues to execute its growth strategy. The recent developments reinforce investor confidence in Telix's ability to sustain its growth trajectory in a competitive industry landscape. Gain insights into Telix Pharmaceuticals' past trends and performance with our report on the company's historical track record. 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 ASX:TLX. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@
Malaysian Reserve
7 days ago
- 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:
Yahoo
7 days ago
- Business
- Yahoo
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
Malaysian Reserve
05-05-2025
- Business
- Malaysian Reserve
Telix's Illuccix® PSMA-PET Imaging Agent Approved in the Czech Republic
New approval provides hospitals and clinics in the Czech Republic with access to a proven PSMA-PET imaging agent MELBOURNE, Australia, May 5, 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 the Czech Republic by the SÚKL[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 provides healthcare providers in the Czech Republic with broader access to PSMA-PET[3] imaging, using a clinically validated gallium-based radiopharmaceutical. Illuccix, after radiolabelling with gallium-68, is indicated in the Czech Republic 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 advance 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 recognize 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]. President of the Czech Society of Nuclear Medicine, Dr. David Zogala commented on the approval, 'Waiting for a diagnosis can be a difficult time for men with suspected prostate cancer. In this regard, PSMA-PET imaging has transformed how we assess the disease, offering greater accuracy and confidence in determining its stage, and guiding the correct course of action. The approval of Illuccix will increase access to advanced imaging in the Czech Republic, broadening the portfolio of available PSMA tracers and supporting precise detection and timely decision-making for patients.' 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. 'The Czech Republic has been at the forefront of adopting advanced diagnostics, with Czech nuclear medicine specialists playing a leading role in integrating PSMA-PET imaging into clinical practice. We are pleased to support their efforts by working with THP Medical Products to deliver Illuccix, a clinically validated imaging solution that will help ensure more men benefit from accurate prostate cancer detection and ongoing management.' said Raphaël Ortiz, Chief Executive Officer, Telix International. Illuccix® will be made available in the Czech Republic through Telix's distribution partner THP Medical Products a specialist supplier and distributor of nuclear medicine products and services. To order or enquire about Illuccix® availability, authorized healthcare professionals in the Czech Republic can email: [email protected] or call +43 1 292 82 80. Prostate Cancer in the Czech Republic Prostate cancer is the most common cancer in men in the Czech Republic, with close to 8,000 new cases diagnosed annually, and a significantly higher incidence in men than either bowel (4,376 new cases) or lung cancer (3,709 new cases). Prostate cancer is also the third most common cause of cancer death in men, with over 1,600 men dying from their disease in the Czech Republic 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 U.S. Food and Drug Administration (FDA)[8], by the Australian Therapeutic Goods Administration (TGA)[9], by Health Canada[10], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[11], by the Brazilian Health Regulatory Agency (ANVISA)[12], by the French National Agency for the Safety of Medicine and Health Products (ANSM)[13], and in multiple other European Economic Area (EEA) Member States[14]. Illuccix® is currently in national approval review elsewhere in the EEA following a positive decentralized procedure (DCP) opinion by BfArM[15]. [1] Positron emission tomography. [2] Státní Ústav Pro Kontrolu Léčiv (State Institute for Drug Control). [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] 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 13 February 2025. [12] Telix ASX disclosure 18 March 2025. [13] National Agency for the Safety of Medicine and Health Products (Agence nationale de sécurité du médicament et des produits de santé). Telix media release 29 April 2025. [14] Czech Republic, Denmark, Ireland, Luxembourg, Malta, the Netherlands, Norway and Sweden at time of release. [15] The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte). Telix ASX disclosure 17 January 2025. 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 WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: [email protected] 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. Logo – View original content:
Yahoo
29-04-2025
- Business
- Yahoo
Telix Reports US$186M Q1 Revenue, Up 62% YOY
MELBOURNE, Australia and INDIANAPOLIS, April 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today provides an update on its commercial and operational performance for the quarter ended 31 March 2025 (Q1 2025). All figures are in $US unless stated otherwise. Strong Q1 2025 revenue growth Q1 2025 unaudited revenue of approximately $186 million represents an increase of 62% over the prior year corresponding quarter (Q1 2024: $115M) and a quarter-over-quarter increase of 31% (Q4 2024: $142 million) and includes: $151 million from global sales of Illuccix®, up 35% over the prior year corresponding quarter (Q1 2024: $112 million) and a quarter-over-quarter increase of 9% (Q4 2024: $139 million). $33 million from RLS Radiopharmacies (RLS) since the acquisition completed on 27 January 20251. FY 2025 guidance reaffirmed Telix confirms FY 2025 revenue guidance of $770 million to $800 million2. Guidance reflects revenue from Illuccix® sales in jurisdictions with a marketing authorization, and 11 months of revenue from RLS1,3. Revenue guidance is expected to be updated at the appropriate time, following and subject to reimbursement for Gozellix® in the United States (U.S.) and Illuccix® in ex-U.S. markets. Telix confirms research and development (R&D) expenditure guidance, expecting a year-over-year increased investment range for FY 2025 of 20% to 25% compared to FY 2024. Q1 2025 commentary and recent highlights Telix Managing Director and Group CEO, Dr. Christian Behrenbruch, stated, 'Illuccix has continued its momentum, gaining market share and maintaining price stability in a competitive landscape. Telix is the only company with two FDA4-approved PSMA-PET5 imaging agents – Illuccix and Gozellix – enabling us to broaden patient reach and maximize choice for our customers. The expansion of our commercial portfolio and launches of Illuccix into new international markets provides a foundation to diversify and grow revenue globally, while we continue to deliver on multiple catalysts in our pipeline. This quarter also includes the first two months of revenue from RLS since completion of our acquisition, highlighting its potential as a platform to drive further growth. This strategic acquisition has significantly expanded our manufacturing footprint in the U.S., which we believe is an increasingly important consideration amid changing global trade dynamics.' Therapeutics business ProstACT™ Global, the Phase 3 trial of TLX591 (177Lu-rosopatamab tetraxetan), Telix's prostate cancer therapy candidate, continues to recruit and remains on track to deliver a Part 1 readout (safety and dosimetry) in H1 2025. IPAX-Linz, a Phase 2 investigator-initiated trial of TLX101 (131I-iodofalan, or 131I-IPA), Telix's brain cancer therapy candidate, reported positive preliminary results. Early efficacy from IPAX-1 was substantiated and TLX101 was found to be well tolerated in combination with external beam radiation therapy. No serious adverse events were reported in patients at first or second recurrence with high-grade gliomas (HGG), including glioblastoma, often after multiple resections6. Following consultations with the FDA, the Company remains on track to submit Investigational New Drug (IND) applications to enable pivotal trials for TLX101 and Telix's kidney cancer therapy candidate (TLX250, 177Lu-DOTA-girentuximab) to commence this year, subject to regulatory approval. The first patient was dosed in the Phase 1 ZOLAR7 trial of TLX300-CDx (89Zr-olaratumab), which aims to validate the use of olaratumab, an antibody exclusively licensed from Eli Lilly and Company (Lilly), as a potential treatment for advanced, metastatic soft tissue sarcoma. Telix completed the acquisition of a suite of clinically validated FAP8-targeting therapeutic and precision medicine (diagnostic) radiopharmaceutical candidates. Telix has added the lead FAP-targeting therapeutic compound to its pipeline under the designation TLX400. Telix acquired the therapeutics assets of antibody engineering company ImaginAb, Inc. The transaction included a pipeline of next-generation therapeutic candidates, a proprietary novel biologics technology platform, and a protein engineering and discovery research facility in Los Angeles, California9, staffed by a talented team of discovery, protein engineering and radiopharmaceutical development experts who joined the Company on the ImaginAb acquisition closing. Telix announced that it has developed and validated a breakthrough generator technology for the production of lead-212 (212Pb) and successfully completed first production of this promising alpha-emitting therapeutic radioisotope10. The new generator technology, developed internally by Telix's IsoTherapeutics team, significantly increases the amount of radioactivity, yield and shelf life compared to currently available 212Pb generators and provides an additional isotope supply for Telix's next-generation targeted alpha therapy program. Precision Medicine business On 21 March 2025, the FDA approved the New Drug Application (NDA) for Gozellix®11, Telix's next-generation PSMA-PET imaging agent for prostate cancer that provides a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based imaging products. Commercial launch of Gozellix® in the U.S. is expected to commence during Q2 2025 where Telix has appointed Cardinal Health, Inc. (Cardinal Health)12 and RLS Radiopharmacies as distribution partners. Telix received a positive decision on the decentralized Marketing Authorization Application (MAA) for Illuccix® in the European Economic Area (EEA)13. Illuccix® also received MAA approval in the United Kingdom (UK) and Brazil. Country level approvals are now being implemented in the EEA, with approvals to date granted in Denmark, Ireland, Luxembourg, Malta, the Netherlands, Norway, and Sweden14. Illuccix® is now commercially available in Brazil, under the joint venture with R2PHARMA (Telix Innovations Brazil, Ltda.), and commercial launches will commence in the UK and in European markets where Illuccix® has received approval during Q2 2025. The FDA accepted the Biologics License Application (BLA) for Telix's kidney cancer imaging candidate TLX250-CDx (Zircaix®15, 89Zr-DFO-girentuximab), granted a Priority Review, and provided a PDUFA16 goal date of 27 August 2025. The NDA for TLX101-CDx (Pixclara®15, 18F-floretyrosine or 18F-FET), Telix's brain cancer imaging candidate, continues to progress with a PDUFA goal date of 26 April 2025. Telix Manufacturing Solutions (TMS) In April, the TMS Brussels South facility (Seneffe) received notice of its GMP accreditation, enabling first commercial radiopharmaceutical dose production. Telix reaffirms that it does not expect any material impact on its business or supply chain as a result of the international trade tariffs announced by the U.S. government on 2 April 2025 (subject to a three-month delay) or the subsequent inclusion of pharmaceuticals. Telix has an extensive U.S.-based manufacturing and distribution infrastructure, including third-party manufacturing sites and radiopharmacy partner networks, for the production and delivery of its FDA-approved products Illuccix® and Gozellix®17. Telix also notes that it does not rely on rare earth elements of the kind utilized in semi-conductor supply chains and is therefore not impacted by the recent export controls imposed by the Chinese government this month. Board renewal Telix announced new Director appointments as part of a Board succession planning and renewal process18: H Kevin McCann AO will retire as a Non-Executive Director (NED) and Board Chairman on 21 May 2025, immediately following Telix's Annual General Meeting. Tiffany Olson will be appointed Board Chair following Mr. McCann's retirement. Marie McDonald joined the Board as a NED, effective 3 March 2025 and, on appointment, immediately succeeded Mr. McCann as Chair of the People Committee. Anne Whitaker joined the Board as a NED, effective 7 April 2025, and was appointed as a member of the Audit and Risk Committee and the People Committee. Guidance disclaimer The stated revenue guidance is based on expected global and domestic economic conditions and is subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially. As such, investors are cautioned not to place undue reliance on this guidance and in particular Telix cannot guarantee a particular result. In compiling financial forecasts, a number of key variables that may have a significant impact on guidance have been identified and are listed below. Key variables that could cause actual results to differ materially include: the success and timing of research and development activities; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation, regulation, or policy that affects product production, distribution, pricing, reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and Telix's ability to protect its patents and other intellectual property. See the Legal Notices section below for additional information, risks and assumptions. 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 FDA19, the Australian Therapeutic Goods Administration (TGA)20, Health Canada21, the UK Medicines and Healthcare Products Regulatory Agency (MHRA)22, by the Brazilian Health Regulatory Agency (ANVISA)23, and in multiple countries within the European Economic Area (EEA)24. Illuccix® is currently in national approval review elsewhere in the EEA following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM25. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the FDA26. Telix's osteomyelitis (bone infection) imaging agent, technetium-99m (99mTc) besilesomab, marketed under the brand name Scintimun®, is approved in 32 European countries and Mexico. Telix's miniaturized surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, is registered with the FDA for use in the U.S. and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area. No other Telix product has 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: Telix Investor Relations (U.S.) Annie KasparianTelix Pharmaceuticals LimitedDirector 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 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 Excludes revenue contribution from Illuccix® sales.2 Refer to ASX disclosures 20 February 2025. 3 See Guidance Disclaimer for further information.4 U.S. Food and Drug Administration.5 Imaging of prostate-specific membrane antigen with positron emission tomography.6 Telix ASX disclosure 16 April 2025.7 Telix media release 1 April 2025. ID: NCT06537596.8 Fibroblast activation protein.9 Telix ASX disclosure 13 January 2025.10 Telix media release 13 March 2025.11 Telix ASX disclosure 21 March 2025.12 Telix media release 8 April 2025.13 Telix ASX disclosure 17 March 2025.14 Illuccix® received marketing authorization in the UK, Brazil, Denmark, Luxembourg, Malta, the Netherlands and Norway during Q1 2025. Illuccix® received marketing authorization in Ireland and Sweden on 4 and 11 April 2025, respectively. 15 Brand name subject to final regulatory approval. 16 Prescription Drug User Fee Act. 17 Telix ASX disclosure 7 April 2025.18 Telix ASX disclosure 26 February 2025.19 Telix ASX disclosure 20 December 2021.20 Telix ASX disclosure 2 November 2021.21 Telix ASX disclosure 14 October 2022.22 Telix ASX disclosure 13 February 2025.23 Telix ASX disclosure 18 March 2025.24 Denmark, Ireland, Luxembourg, Malta, the Netherlands, Norway and Sweden at time of release.25 Telix ASX disclosure 17 January 2025.26 Telix ASX disclosure 21 March in to access your portfolio
