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Heavy Transport Market Overview and Leading Players: Hitachi Transport System, Fagioli S.p.A., Nationwide Transport Services, Holleman, Van der Vlist, Turk, DB Cargo, Heavy Weight TransportMELBOURNE, Australia and INDIANAPOLIS , Dec. 30, 2024 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix®[1], 89 Zr- girentuximab) kidney cancer imaging[2]. TLX250-CDx is an investigational PET[3] drug product for the non-invasive diagnosis and characterisation of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. If approved, TLX250-CDx will be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the U.S., further building on Telix’s successful urology imaging franchise. The FDA is expected to advise the PDUFA[4] goal date following the 60-day administrative review of the application. Kevin Richardson , Chief Executive Officer, Precision Medicine at Telix, stated, “We are pleased to be progressing the BLA for TLX250-CDx, which has been granted Breakthrough designation, and may therefore be eligible for priority review. Telix continues to target a full U.S. commercial launch in 2025 addressing a major unmet medical need for patients with suspected ccRCC.” About TLX250-CDx TLX250-CDx (Zircaix® 1 ) is an investigational PET agent that is under development for the diagnosis and characterisation of ccRCC. Telix’s pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118 ) 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% positive-predictive value 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 characterising ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia , with international operations in the United States , Europe ( Belgium and Switzerland ), and Japan . Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX). Telix’s lead imaging product, gallium-68 ( 68 Ga) gozetotide injection (also known as 68 Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)[6], by the Australian Therapeutic Goods Administration (TGA) [7], and by Health Canada [8] . No other Telix product has received a marketing authorisation in any jurisdiction. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn . Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: kyahn.williamson@telixpharma.com 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 registration statement 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. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix® and Zircaix® 1 names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. View original content to download multimedia: https://www.prnewswire.com/apac/news-releases/telix-files-tlx250-cdx-zircaix-bla-for-kidney-cancer-imaging-302339972.html SOURCE Telix Pharmaceuticals LimitedWarriors predicted to trade Jonathan Kuminga for Trail Blazers' $208 million duo | Sporting News
CNBC Daily Open: The perils of market predictionsPublished 10:22 pm Sunday, December 29, 2024 By Data Skrive Today’s NBA schedule features several top-tier games, including the matchup between the Dallas Mavericks and the Sacramento Kings. Looking for additional betting info for today’s NBA action? We’ve got you covered with odds for each of the big games in the article below. Sign up for NBA League Pass to get access to games, live and on-demand, and more for the entire season and offseason. Watch ESPN originals, The Last Dance and more NBA content on ESPN+. Use our link to sign up for ESPN+ or the Disney bundle. Not all offers available in all states, please visit BetMGM for the latest promotions for your area. Must be 21+ to gamble, please wager responsibly. If you or someone you know has a gambling problem, contact 1-800-GAMBLER .Dusty May, No. 14 Michigan try to continue strong start vs. Arkansas
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Morrissey throws 67-yard TD pass to Calwise Jr. to lift Eastern Kentucky over North Alabama 21-15The Top Ten Open Source Boilerplates of 2024OTTAWA, Ontario (AP) — Tuomas Uronen scored at 1:46 of overtime to give Finland a 4-3 victory over the defending champion United States on Sunday in the world junior hockey championship. Uronen, who plays for the Kingston Frontenacs in the Ontario Hockey League, came down the right side on a rush and beat goalie Trey Augustine high to the glove side. The Americans lost for the first time in three games. They'll finish Group A play Tuesday night against Canada. Finland has won two straight after an opening loss to Canada. In the late game at Canadian Tire Centre, Carter George made 18 saves to help Canada rebound from an overtime loss to Latvia with a 3-0 victory over Germany. Jesse Kiiskinen, Julius Miettinen and Arttu Alasiurua also scored for Finland, and Petteri Rimpinen made 41 saves. Carey Terrance of the Erie Otters of the OHL, Cole Hutson of Boston University and Brody Ziemer of Minnesota scored for the United States. Augustine, from Michigan State, stopped 29 shots. For Canada, Oliver Bonk opened the scoring midway through the first period, Caden Price made it 2-0 with 4:58 left in the game and Mathieu Cataford added an empty-netter. In Group B at TD Place, Sweden and Czechia each improved to 3-0 ahead of their showdown Tuesday night in the round-robin finale. Tom Willander had two goals and assist in Sweden's 7-5 victory over Switzerland. Eduard Sale scored twice to help Czechia beat Slovakia 4-2. AP sports: https://apnews.com/sports