Latest news with #Zircaix
Yahoo
6 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
News.com.au
28-04-2025
- Business
- News.com.au
Health Check: Telix licks its wounds after FDA knocks back brain cancer diagnostic
The FDA has told Telix to do more work on its imaging agent for rare brain cancers But the agency tells Dimerix it can use a surrogate endpoint for its kidney disease drug candidate Emvision opens a second US site to test its stroke detection tool Telix Pharmaceuticals (ASX:TLX) will seek a 'please explain' from the US Food & Drug Administration (FDA) after the agency rejected the company's marketing approval application for its brain cancer (glioma) diagnostic tool, Pixclara. The shock news sent Telix shares down as much as 10% this morning. 'This was obviously a disappointing outcome and not what was expected by the company,' said Telix CEO Dr Chris Behrenbruch. In a so-called complete response letter (CRL), the agency said the entreaty could not be approved without 'additional confirmatory clinical evidence'. Pixclara – TLX101-CDx – is a nuclear imaging agent for glioma, a rare and life-threatening brain cancer. Currently the FDA has not approved any targeted PET (positive emission tomography) agents for brain cancer imaging. This is despite the technology underlying Pixclara (PET-FET) being used widely elsewhere. Blindsided The company is baffled because the FDA reviewers did not raise any concerns in the lengthy consultation process. The issues appeared to emerge at the late stage, when the parties discussed specific product labelling. The FDA already had granted orphan drug and fast-track designation to Pixclara, which has been used in early access programs on compassionate grounds. Choosing his words carefully, Behrenbruch said he believed the decision reflected 'a change of culture' at the FDA over the last few months. 'We don't think it's a decision that reflects the scientific merit or patient risk benefit of the data,' he told a webinar this morning, adding the parties seemed clear on the data that would be used. He was not suggesting the FDA had become 'less scientifically led', but there was 'less flexibility than we had seen previously towards the back end of the process'. Behrenbruch says Telix has several options to address the CRL concerns, including re-analysing existing (undisclosed) data, or carrying out additional clinical trials. Put in context, the FDA has approved two Telix prostate cancer diagnostics. The company is deriving strong revenues from the first, Illucix. Knock back should not affect kidney application One issue is the potential impact on the company's kidney imaging agent Zircaix, which the FDA currently is reviewing. Behrenbruch said Pixclara was filed under a more flexible and 'creative' process called the 505 (b2) pathway. 'The two should not be conflated,' he said. Given the accepted use of FET-PET elsewhere, the company did not back the Pixclara application with a definitive pivotal trial. 'Zircaix was based on two phase III trials, which far exceeded all their primary and secondary endpoints,' Behrenbruch said. 'We are dealing with a completely different submission process.' Telix estimates the US glioma opportunity at US$100-$140 million per year. Expanding to additional indications (such as brain metastases) could boost this market to US$475-665 million. Given Pixclara has not yet been approved, the the knock-back does not affect the company's current-year revenue guidance. Still, the episode sounds a warning to FDA applicants that everyone may no longer may be on the same page. Dimerix can adopt a surrogate The FDA has delivered Dimerix (ASX:DXB) cheerier news, deeming a so-called surrogate endpoint to be adequate to support potential marketing approval of its drug for a rare kidney disease. The endpoint is proteinuria – protein in the urine – a tell-tale sign the spuds are not working too well. A traditional endpoint such as patients' overall survival is problematic, because complete renal failure and death may not be evident for years. Dimerix is in phase III trial stage for focal segmental glomerular sclerosis, called Action 3, with an interim analysis showing DMX-200 reduced proteinuria after 35 weeks' treatment. Dimerix CEO Dr Nina Webster describes the FDA decree as an 'exceptional outcome, particularly given that DMX-200 has previously demonstrated positive effects on this endpoint in both pre-clinical and clinical studies.' The company says 183 out of 286 intended patients have been dosed in the Action 3 study, with results expected next year. The FDA also remains 'open to discussion' on endpoints that could support accelerated approval. Pacific Edge fights for pay despite adverse US ruling Kiwi diagnostics house Pacific Edge (ASX:PEB) says it will continue to fight for restoration of US Medicare reimbursement for its bladder cancer tests, despite a legal setback. Last week a Pennsylvania District Court judge ruled that her court lacked jurisdiction to hear Pacific Edge's claim against Novitas – the relevant Medicare contractor – and the Center of Medicare and Medicaid (CMS). Mind you the beak in question, Judge Keli M. Neary, noted the company had marshalled 'incredibly compelling facts for why its test is a medical marvel'. Pacific Edge's lobbying efforts have been in vain, despite heavyweight support from the American Urological Association (AUA). Reimbursement expired on April 24. The company's Cxbladder test cover detection and triaging of patients and ongoing monitoring. Pacific Edge now intends to appeal to the Medicare system, arguing its triage tool is included in AUA clinical guidelines. It will also pursue coverage for is monitoring tool, but not the detection product as 'no new evidence has been published that can be submitted for reconsideration.' Pacific Edge derives 60% of its US revenue from Medicare – and most of its overall revenue from Trumpland – so it's no small beer. Pacific Edge CEO Dr Peter Meintjes says the 'flawed process … failed to review the most-current evidence.' On the bright side, Pacific Edge expects to receive uninterrupted reimbursement from contracted commercial US payers, including US Veterans Administration. Mayo-my as Emvision opens second trial site Emvision has added a second US site for its pivotal trial of its portable stroke detection tool, at Mayo Clinic in Jacksonville, Florida. The company plans a site initiation visit and device training in early May. The Mayo site augments an existing one at the UTHealth and Memorial Hermann-Texas Medical Center. The trial aims for FDA clearance of Emu, a point-of-care brain scanner for early detection and classification of strokes. The company says additional US and Australian trial site will be 'announced and activated shortly'. Percheron board survives – again The Percheron Therapeutics (ASX:PER) board has survived a second spill attempt following December's failure of its flagship Duchenne muscular dystrophy (DMD) program. On Thursday the company said shareholders had voted against removing chairman Dr Charmain Gittleson, CEO James Garner and another director, by a margin of approximately 72-73%. Curiously, the requisitioning party, Powerhouse Ventures, had halved its stake ahead of the meeting, to just over 5%. To use a timely political analogy, the board enjoyed a swing in its favour. In March another ginger group failed to eject chairman Gittleson and Garner, by a margin of 55-56% . 'It is now time to put these disputes behind us and focus our entire efforts on the vital task of restoring value for shareholders,' Gittleson says. With the DMD program dead, buried and cremated, the board plans to use the company's remaining cash to acquire an alternative program.
News.com.au
23-04-2025
- Business
- News.com.au
Health Check: Telix shares rocket after bullish quarterly sales update
Telix's quarterly sales reflect first revenue from the company's recent purchase of a US nuclear medicine manufacturer Island Pharma hopes to lift the kimono on its dengue fever trial next month Race Oncology kicks off its cancer-busting, cardioprotective trial Having gleaned all its revenue to date from its US-approved prostate cancer imaging agent Illucix, Telix Pharmaceuticals (ASX:TLX) is starting to reap the benefit of its acquisition of a US nuclear medicine manufacturer. In September last year Telix paid US$230 million for RLS Radiopharmacies, which has 31 nuclear pharmacies dotted across Trumpland. Telix has reported March quarter revenue of US$186 million, 62% higher year on year and 31% up on the December quarter. This includes a robust US$33 million from RLS, which Telix formally acquired on January 27 this year. 'This strategic acquisition has significantly expanded our manufacturing footprint in the US, which we believe is an increasingly important consideration amid changing global trade dynamics,' says Telix chief Dr Chris Behrenbruch. Ah, tariffs! We get it. Illucix sales continue at a decent clip: US$151 million, up 35% year on year. 'Illuccix has continued its momentum, gaining market share and maintaining price stability in a competitive landscape,' Behrenbruch says. Telix has affirmed guidance of full-year (calendar 2025) revenue of US$770-800 million, including eleven months of RLS sales. The guidance is subject to change, given the US Food and Drug Administration (FDA) on March 21 approved Telix's second diagnostic, Gozellix (also for prostate cancer). Telix hopes to launch Gozellix in the US in the current quarter, having appointed RLS and Cardinal Health as distribution partners. Bursting development pipeline Meanwhile, Telix expects FDA approval for its brain imaging candidate Pixclara by the end of this week – April 26. As per the FDA's timetable, the agency should approval Telix's kidney cancer imaging candidate Zircaix by August 27. Investors should expect an initial safety and dosing readout on phase III trial results for Telix's prostate cancer therapy (as opposed to diagnostic) in the current half. Telix also hopes to submit an FDA investigational new drug application for its kidney cancer therapeutics, in view of a late-stage pivotal trial. Adding to Telix's packed agenda, the company has earlier stage programs for a brain cancer therapy (phase II) and advanced, metastatic soft tissue sarcoma (phase I). Telix shares this morning rocketed as much as 15%, but they are still well shy of their February 25 zenith of just over $31. Investors may question just how much of the excitement is factored into Telix's $9.7 billion market capitalisation. Island promises trial results next month Island Pharmaceuticals (ASX:ILA) investors won't have to wait too much longer for results from the second stanza of the company's phase 2a/b dengue fever trial. The 2a phase assessed the preventative qualities of Island's drug candidate ISLA-101 in four undiseased subjects, one of whom was administered a placebo. The drug was deemed safe, with 'evidence of anti-dengue activity". The 2b stage had enrolled ten patients who are administered a weakened form of the virus. Eight of them are administered ISLA-101, with two receiving a placebo. Pharmacokinetic tests showed the drug reached the bloodstream in desired quantities. Next month's results will outline the efficacy. Carried by mosquitos, dengue fever has become a major health problem as it spreads at a rate that makes cane toads look slothful. Race to start cancer trial Race Oncology (ASX:RAC) expects to treat the first patient in its local phase 1 trial that tests its drug candidate RC-220 alongside a common chemotherapy agent. RC-220 is a reformulated version of bisantrene, which was developed as a leukemia drug in France in the 1980s, but was never commercialised for reasons lost in the midst of time. RC-220 shows promise not just for its cancer-busting properties, but its ability to protect the heart from the dire effects of chemotherapy. The trial custodians are treating initial patients at the Southside Cancer Care Centre at Sydney's Miranda. Race has also gained ethics approval to open sites at the Gosford and Wyong hospitals. Race's March quarterly report discloses cash of $17.12 million, with 70% of the $1.67 million quarterly burn devoted to R&D. 'This prudent cash management enables Race to fund all announced clinical and preclinical programs through calendar 2026," the company says. Race costs the circa 53-patient RC-220 trial at $8.58 million. An FDA decision to dye for The latest decision by US health czar Robert F. Kennedy Junior and FDA commissioner Marty Makary could be one of their least controversial. The FDA has banned petroleum-based synthetic dyes from food, as used sweets, soft drinks and other stuff that isn't good for you. Depending on their colour, dyes are thought to be carcinogenic or cause behavioural problems in some children. One of President Biden's last acts in power was to ban an especially controversial red dye from food and ingested drugs, after the additive was found to cause cancer in rats. Technically, the dye no longer is 'generally recognised as safe'.
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. View original content to download multimedia: SOURCE Telix Pharmaceuticals 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 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.
