Latest news with #KevinRichardson
Winnipeg Free Press
01-05-2025
- Business
- Winnipeg Free Press
‘Anything we do here as a business is done with the province in mind': Shapes looks to build on three-decade run in Winnipeg
A few years ago, Kevin Richardson came up with a slogan to use when telling people about Shapes Fitness Centres: 'Created by a Winnipegger in Winnipeg for Winnipeggers.' The former biochemist, who has worked at the chain since 2017, admits as far as a motto goes, it's unwieldy. But it expressed something he wants people to know: Shapes, which has gyms across the city, is locally owned and operated. 'I was telling people we're only in Winnipeg and people would be surprised,' Richardson says. 'Over and over they would say, 'I didn't know it was local only, and I grew up here.'' RUTH BONNEVILLE / FREE PRESS Kevin Richardson plans to raise awareness about the company's Winnipeg roots with a new 'shop local' social media campaign launching later this month. Chris Rousseau opened the first Shapes gym on Nairn Street in September 1994. Today, there are six: three women's-only locations and three co-ed locations, all of them open 24 hours a day, seven days a week. They include hundreds of pieces of fitness equipment, offer more than 380 group fitness classes each week and employ almost 200 people. Rousseau's son and daughter-in-law, Lyle Rousseau and Christina Teixeira, handle the company's day-to-day operations. 'Chris wanted to offer something made for Manitobans. Anything we do here as a business is done with the province in mind,' Teixeira says. 'In the 31 years, Shapes has withstood time and competition and is still standing, stronger than ever.' One reason the company has lasted is because it's changed with the times. If you walked into a Shapes gym in 1994, you would have encountered free weights, weight lifting machines and treadmills. Those things are still there today, but they're only part of what the business offers. Take for example the company's 1910 Pembina Hwy. location, which underwent a multimillion-dollar renovation five years ago. It includes a cycle room for spin classes, hot yoga studio, room dedicated to high-intensity interval training, monkey bar-like contraption called a Queenax rig for functional training, and a climbing wall. Patrons can relax in massage chairs and the changing rooms include saunas and tanning booths. 'Our goal is to offer what you would find at multiple standalone facilities under one roof at the best possible price,' Teixeira says. RUTH BONNEVILLE / FREE PRESS An instructor checking out the ropes at their new climbing wall. 'We believe we're the right place and we believe it just has to be the right time for customers,' she adds. 'It's our job to help them when they realize it's time to put themselves first.' Teixeira was a university student when she started working at Shapes 17 years ago. 'I fell in love with the people and that's really what this job is: being excited for people actually seeing their fitness goals through or incorporating fitness into their life.' People don't enter a gym on a whim, Teixeira adds. Something is motivating them. It could be someone's made a comment about their appearance or their clothes don't fit the way they want or they're not sleeping well. Shapes staff aim to put newcomers at ease and create an environment where everyone feels welcome. 'When someone walks through that front door, I want them all to understand we all start somewhere. There's a Day 1 for all of us,' she says. 'Put all that hesitation and all those worries behind you. 'Just come and have a talk with someone and you'll be surprised by how you feel when you leave. Nobody's worth it more than you are, when it comes down to it.' Richardson understands. As a university student, he enjoyed working out with friends and ran a few marathons. But by the time he was in his mid-40s, health had taken a backseat to a demanding career in the pharmaceutical industry. He was sedentary, working late nights and eating a lot of fast food. 'I was developing drugs for Type 2 diabetes and at the same time, I was developing Type 2 diabetes myself,' he says. RUTH BONNEVILLE / FREE PRESS The company's 1910 Pembina Hwy. location, underwent a multimillion-dollar renovation five years ago and includes a High-Intensity Interval Training (HIIT) room. In 2016, when he found out he was going to become a father for the first time, Richardson decided to invest in his health. Through a combination of exercise and changes to his diet, he lost 100 pounds. The next year, he started working at Shapes as a trainer. Today, he's the company's wellness manager — a nebulous title that allows Richardson to take on a variety of duties, including leading corporate wellness initiatives that help businesses support the health of their employees. For Richardson, the mental health benefits that come from working out are just as important as the physical outcomes. One of the things he likes about Shapes is it allows people to get away from their homes and where they work and come together with people of all ages who are working toward a common goal: improving their health. 'I know how hard it is to start living a healthier lifestyle and I don't have any secrets — there are none,' he says. 'But I want people to rethink the gym … It's not what you think it is. You don't have to do as much as you think and the benefits are better than you think it could be.' Richardson plans to raise awareness about the company's Winnipeg roots with a new 'shop local' social media campaign launching later this month. Rather than just put Shapes in the spotlight, the campaign will highlight other Manitoba businesses, too — companies that people might not know originated in the keystone province. Coal and Canary, Stella's and Chocolatier Constance Popp are a few of the businesses that will be featured. Constance Menzies has been passionate about promoting local products ever since she started Chocolatier Constance Popp in 2007 — her offerings include two Manitoba-shaped confections — and appreciated getting Richardson's invitation to participate. RUTH BONNEVILLE / FREE PRESS Shapes member Alp Vaid makes his way across the Queenax training system Monday Mornings The latest local business news and a lookahead to the coming week. 'Kevin has just got great energy around him. It's easy to get motivated by the work that he does,' Menzies says. 'I think he appreciates local, Manitoba-made work and I think he has a respect for local business owners, as well.' In Menzies' experience, consumers are increasingly interested in buying local because it allows them to meet the people who make the products they're purchasing. 'Kevin gets that, so that's very cool.' Richardson wants to highlight as many companies as he can with the campaign. 'We're not looking for anything in return,' he says. 'We're just happy we've been successful for 31 years. Maybe we can help you be successful for 31 years or more.' Aaron EppReporter Aaron Epp reports on business for the Free Press. After freelancing for the paper for a decade, he joined the staff full-time in 2024. He was previously the associate editor at Canadian Mennonite. Read more about Aaron. Our newsroom depends on a growing audience of readers to power our journalism. If you are not a paid reader, please consider becoming a subscriber. Our newsroom depends on its audience of readers to power our journalism. Thank you for your support.
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
- Yahoo
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
Yahoo
26-02-2025
- Business
- Yahoo
FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review
MELBOURNE, Australia, Feb. 26, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET[1] imaging agent TLX250-CDx (Zircaix®[2], 89Zr-DFO-girentuximab), granted a Priority Review and provided a PDUFA[3] date of 27 August 2025, paving the way for a U.S. commercial launch in 2025. If approved, TLX250-CDx will become the first commercially available imaging agent to accurately and non-invasively diagnose and characterize clear cell renal cell carcinoma (ccRCC), the most common and one of the most aggressive sub-types of kidney cancer. It works by specifically binding to carbonic anhydrase IX (CAIX), a validated target protein expressed on 95% of ccRCC cells to produce images with high tumor-to-background ratio and high intra- and inter-reader consistency. The BLA is based on Telix's successful global Phase 3 ZIRCON[4] study, which demonstrated a sensitivity of 86%, specificity of 87% and a positive predictive value (PPV) of 93% for ccRCC, including in very small, difficult-to-detect lesions[5]. The results of this study were published in The Lancet Oncology in September 2024, in a peer-reviewed manuscript by Professor Brian Shuch (University of California, Los Angeles, UCLA) and colleagues[6]. The paper outlines the critical unmet need for a new, non-invasive technique that can accurately detect and differentiate ccRCC from other renal masses in patients and concluded that TLX250-CDx meets this need and 'has the potential to be practice changing.' Kevin Richardson, Chief Executive Officer, Precision Medicine, said, "We are delighted that the FDA has accepted this BLA as it moves us one step closer to bringing our breakthrough product to patients. We are aiming to revolutionize the management of kidney cancer, just as PSMA-PET/CT[7] scanning has changed the management of prostate cancer. By providing a more definitive clinical diagnosis for renal masses, we believe that Zircaix[2] will help physicians make more timely and confident patient management decisions and more quickly provide patients with a clear understanding of their disease and treatment options. Building further on Telix's successful urology franchise, we are preparing to bring this powerful precision medicine product to market in 2025[8]." About TLX250-CDx TLX250-CDx (Zircaix®[2]) is an investigational PET agent that is under development for the diagnosis and characterization of ccRCC. Telix's pivotal Phase 3 ZIRCON trial evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% PPV for ccRCC across three independent radiology readers[5]. Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation. As part of Telix's commitment to access to medicine, the Company operates an expanded access program (EAP) in the U.S.[9], named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx outside of a clinical trial, to patients for whom there are no comparable or satisfactory alternate options. TLX250-CDx has not received a marketing authorization in any jurisdiction and is for investigational use only. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX). Visit for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. [1] Positron emission tomography.[2] Brand name subject to final regulatory approval. [3] Prescription Drug User Fee Act. [4] Zirconium in Renal Cancer Oncology, ID: NCT03849118.[5] Telix ASX disclosures 7 November 2022.[6] Shuch et al. Lancet Oncology. 2024.[7] Imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography.[8] Subject to regulatory approval.[9] ID: NCT06090331. 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26-02-2025
- Business
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FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review
MELBOURNE, Australia and INDIANAPOLIS, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET1 imaging agent TLX250-CDx (Zircaix®2, 89Zr-DFO-girentuximab), granted a Priority Review and provided a PDUFA3 date of 27 August 2025, paving the way for a U.S. commercial launch in 2025. If approved, TLX250-CDx will become the first commercially available imaging agent to accurately and non-invasively diagnose and characterize clear cell renal cell carcinoma (ccRCC), the most common and one of the most aggressive sub-types of kidney cancer. It works by specifically binding to carbonic anhydrase IX (CAIX), a validated target protein expressed on 95% of ccRCC cells to produce images with high tumor-to-background ratio and high intra- and inter-reader consistency. The BLA is based on Telix's successful global Phase 3 ZIRCON4 study, which demonstrated a sensitivity of 86%, specificity of 87% and a positive predictive value (PPV) of 93% for ccRCC, including in very small, difficult-to-detect lesions5. The results of this study were published in The Lancet Oncology in September 2024, in a peer-reviewed manuscript by Professor Brian Shuch (University of California, Los Angeles, UCLA) and colleagues6. The paper outlines the critical unmet need for a new, non-invasive technique that can accurately detect and differentiate ccRCC from other renal masses in patients and concluded that TLX250-CDx meets this need and 'has the potential to be practice changing.' Kevin Richardson, Chief Executive Officer, Precision Medicine, said, 'We are delighted that the FDA has accepted this BLA as it moves us one step closer to bringing our breakthrough product to patients. We are aiming to revolutionize the management of kidney cancer, just as PSMA-PET/CT7 scanning has changed the management of prostate cancer. By providing a more definitive clinical diagnosis for renal masses, we believe that Zircaix2 will help physicians make more timely and confident patient management decisions and more quickly provide patients with a clear understanding of their disease and treatment options. Building further on Telix's successful urology franchise, we are preparing to bring this powerful precision medicine product to market in 20258.' About TLX250-CDx TLX250-CDx (Zircaix®2) is an investigational PET agent that is under development for the diagnosis and characterization of ccRCC. Telix's pivotal Phase 3 ZIRCON trial evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% PPV for ccRCC across three independent radiology readers5. Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation. As part of Telix's commitment to access to medicine, the Company operates an expanded access program (EAP) in the U.S.9, named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx outside of a clinical trial, to patients for whom there are no comparable or satisfactory alternate options. TLX250-CDx has not received a marketing authorization in any jurisdiction and is for investigational use only. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX). Visit for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as 'may', 'expect', 'intend', 'plan', 'estimate', 'anticipate', 'believe', 'outlook', 'forecast' and 'guidance', or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. 1 Positron emission tomography.2 Brand name subject to final regulatory approval. 3 Prescription Drug User Fee Act. 4 Zirconium in Renal Cancer Oncology, ID: NCT03849118.5 Telix ASX disclosures 7 November 2022.6 Shuch et al. Lancet Oncology. 2024.7 Imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography.8 Subject to regulatory approval.9 ID: NCT06090331.
