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Late kickoff return TDs by Turpin and Thomas spark the Cowboys as they end their 5-game skidCLR Neurosthenics® launches neurophysiological assessment platform to help prevent sports injuries, optimize performance and improve rehabilitation
MELBOURNE, 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.
Romania’s presidential elections are heading towards a shock result after the first round held on Sunday, November 24. With about 80% of the votes counted and centralized, independent candidate Calin Georgescu is in the lead, ahead of social democrat prime minister Marcel Ciolacu. Calin Georgescu, 63, has a doctorate in pedology and has worked as a specialist in the environment conservation sector. His messages position him as a candidate with strong nationalistic. The partial results indicated over 1.73 million votes for Georgescu, representing 22% of the 7.85 million ballots counted so far, versus 1.64 million votes (20.9%) for PM Ciolacu. Reformist candidate Elena Lasconi (USR) was third, with 1.33 million votes (17% of the total), followed by far-right leader George Simion (AUR), with 1.13 million votes (14.4% of the total). Liberal leader Nicolae Ciuca was fifth (9.3%) and independent Mircea Geoana, the former NATO deputy secretary general, was only sixth (6.0%). If the current hierarchy doesn’t change, the second round will be fought between independent Calin Georgescu and PSD’s Marcel Ciolacu. However, there were still almost 2 million ballots to count and centralize, mostly from Bucharest and bigger cities and from Diaspora, which may help the USR’s Elena Lasconi close the gap on the top two. The first results coming from abroad from countries such as Germany, Italy and Spain point to an overwhelming vote for Georgescu, according to data centralized by the platform . Meanwhile, the first results from Bucharest, where only 25% of the ballot have been centralized, indicate a score of around 33% for Elena Lasconi, about double compared with PM Marcel Ciolacu. This may result in a tight race for second place between Lasconi and Ciolacu, currently split by about 300,000 votes. If the PM fails to make it to the second round, this will be the biggest shock recorded in Romania's post-Communist elections and the first time that the Social-Democrats are left without a candidate in the final. Even with the PSD leader narrowly qualifying in second place, the results are a total shock for the political establishment in Bucharest, as nobody predicted such a high score for an independent candidate who was almost absent from mainstream media during the campaign. Instead, Calin Georgescu’s campaign focused almost exclusively on social media channels such as Facebook and TikTok, where he gained a lot of traction. The exit polls showed PM Marcel Ciolacu comfortably in the lead, with 25%, and Elena Lasconi second, with 18%, followed by Calin Georgescu with 16%. Meanwhile, the polls carried out since the beginning of November didn't even point to Georgescu as a potential contender for the second round, as his score was estimated at about 5%. Meanwhile, everyone expected a three-way battle for the second place between AUR leader George Simion, PNL's Nicolae Ciuca and USR's Elena Lasconi. The results also show that Romanian voters are profoundly unhappy with the governing parties - PSD and PNL - whose candidates took just about 30% of the votes. Meanwhile, the nationalist current, represented by AUR's George Simion and independent Calin Georgescu, has reached a score of 36%. This leaves the parliamentary elections scheduled for next Sunday, December 1 (Romania's National Day), open to a surprise result as well, depending on who Georgescu's voters decide to support. He is not currently affiliated with any political party, although he was AUR's proposal for the prime minister seat after the 2020 elections. Romania’s presidential elections are heading towards a shock result after the first round held on Sunday, November 24. With about 80% of the votes counted and centralized, independent candidate Calin Georgescu is in the lead, ahead of social democrat prime minister Marcel Ciolacu. Calin Georgescu, 63, has a doctorate in pedology and has worked as a specialist in the environment conservation sector. His messages position him as a candidate with strong nationalistic. The partial results indicated over 1.73 million votes for Georgescu, representing 22% of the 7.85 million ballots counted so far, versus 1.64 million votes (20.9%) for PM Ciolacu. Reformist candidate Elena Lasconi (USR) was third, with 1.33 million votes (17% of the total), followed by far-right leader George Simion (AUR), with 1.13 million votes (14.4% of the total). Liberal leader Nicolae Ciuca was fifth (9.3%) and independent Mircea Geoana, the former NATO deputy secretary general, was only sixth (6.0%). If the current hierarchy doesn’t change, the second round will be fought between independent Calin Georgescu and PSD’s Marcel Ciolacu. However, there were still almost 2 million ballots to count and centralize, mostly from Bucharest and bigger cities and from Diaspora, which may help the USR’s Elena Lasconi close the gap on the top two. The first results coming from abroad from countries such as Germany, Italy and Spain point to an overwhelming vote for Georgescu, according to data centralized by the platform . Meanwhile, the first results from Bucharest, where only 25% of the ballot have been centralized, indicate a score of around 33% for Elena Lasconi, about double compared with PM Marcel Ciolacu. This may result in a tight race for second place between Lasconi and Ciolacu, currently split by about 300,000 votes. If the PM fails to make it to the second round, this will be the biggest shock recorded in Romania's post-Communist elections and the first time that the Social-Democrats are left without a candidate in the final. Even with the PSD leader narrowly qualifying in second place, the results are a total shock for the political establishment in Bucharest, as nobody predicted such a high score for an independent candidate who was almost absent from mainstream media during the campaign. Instead, Calin Georgescu’s campaign focused almost exclusively on social media channels such as Facebook and TikTok, where he gained a lot of traction. The exit polls showed PM Marcel Ciolacu comfortably in the lead, with 25%, and Elena Lasconi second, with 18%, followed by Calin Georgescu with 16%. Meanwhile, the polls carried out since the beginning of November didn't even point to Georgescu as a potential contender for the second round, as his score was estimated at about 5%. Meanwhile, everyone expected a three-way battle for the second place between AUR leader George Simion, PNL's Nicolae Ciuca and USR's Elena Lasconi. The results also show that Romanian voters are profoundly unhappy with the governing parties - PSD and PNL - whose candidates took just about 30% of the votes. Meanwhile, the nationalist current, represented by AUR's George Simion and independent Calin Georgescu, has reached a score of 36%. This leaves the parliamentary elections scheduled for next Sunday, December 1 (Romania's National Day), open to a surprise result as well, depending on who Georgescu's voters decide to support. He is not currently affiliated with any political party, although he was AUR's proposal for the prime minister seat after the 2020 elections. Romania’s presidential elections are heading towards a shock result after the first round held on Sunday, November 24. With about 80% of the votes counted and centralized, independent candidate Calin Georgescu is in the lead, ahead of social democrat prime minister Marcel Ciolacu. Calin Georgescu, 63, has a doctorate in pedology and has worked as a specialist in the environment conservation sector. His messages position him as a candidate with strong nationalistic. The partial results indicated over 1.73 million votes for Georgescu, representing 22% of the 7.85 million ballots counted so far, versus 1.64 million votes (20.9%) for PM Ciolacu. Reformist candidate Elena Lasconi (USR) was third, with 1.33 million votes (17% of the total), followed by far-right leader George Simion (AUR), with 1.13 million votes (14.4% of the total). Liberal leader Nicolae Ciuca was fifth (9.3%) and independent Mircea Geoana, the former NATO deputy secretary general, was only sixth (6.0%). If the current hierarchy doesn’t change, the second round will be fought between independent Calin Georgescu and PSD’s Marcel Ciolacu. However, there were still almost 2 million ballots to count and centralize, mostly from Bucharest and bigger cities and from Diaspora, which may help the USR’s Elena Lasconi close the gap on the top two. The first results coming from abroad from countries such as Germany, Italy and Spain point to an overwhelming vote for Georgescu, according to data centralized by the platform . Meanwhile, the first results from Bucharest, where only 25% of the ballot have been centralized, indicate a score of around 33% for Elena Lasconi, about double compared with PM Marcel Ciolacu. This may result in a tight race for second place between Lasconi and Ciolacu, currently split by about 300,000 votes. If the PM fails to make it to the second round, this will be the biggest shock recorded in Romania's post-Communist elections and the first time that the Social-Democrats are left without a candidate in the final. Even with the PSD leader narrowly qualifying in second place, the results are a total shock for the political establishment in Bucharest, as nobody predicted such a high score for an independent candidate who was almost absent from mainstream media during the campaign. Instead, Calin Georgescu’s campaign focused almost exclusively on social media channels such as Facebook and TikTok, where he gained a lot of traction. The exit polls showed PM Marcel Ciolacu comfortably in the lead, with 25%, and Elena Lasconi second, with 18%, followed by Calin Georgescu with 16%. Meanwhile, the polls carried out since the beginning of November didn't even point to Georgescu as a potential contender for the second round, as his score was estimated at about 5%. Meanwhile, everyone expected a three-way battle for the second place between AUR leader George Simion, PNL's Nicolae Ciuca and USR's Elena Lasconi. The results also show that Romanian voters are profoundly unhappy with the governing parties - PSD and PNL - whose candidates took just about 30% of the votes. Meanwhile, the nationalist current, represented by AUR's George Simion and independent Calin Georgescu, has reached a score of 36%. This leaves the parliamentary elections scheduled for next Sunday, December 1 (Romania's National Day), open to a surprise result as well, depending on who Georgescu's voters decide to support. He is not currently affiliated with any political party, although he was AUR's proposal for the prime minister seat after the 2020 elections.TAMPA, Fla. — The Tampa Bay Buccaneers played like a team determined to do whatever is necessary to make the playoffs. Baker Mayfield and the offense purred, the defense tightened after yielding a touchdown just before halftime, and special teams stood out, too, in a 48-14 rout of the Carolina Panthers that kept the team's division and postseason hopes alive on Sunday. Now, the Bucs (9-7) will see if they get some outside assistance in their bid to make the playoffs for the fifth straight season. “We're just trying to get to the playoffs,” coach Todd Bowles said, shrugging off a question about how Sunday's win ensured a winning record in the regular season. “If we can win next week and get a little help, that will mean a lot to me.” Tampa Bay's fifth win in the past six weeks nudged the first-place Bucs a half-game ahead of the Atlanta Falcons for the best record in the NFC South, with the Falcons set to play on the road later Sunday night at the Washington Commanders. Atlanta holds the tiebreaker in the division race and can end Tampa Bay's three-year reign as NFC South champions by beating the Commanders and winning again next week at home against the last-place Panthers (4-12). Mayfield threw for 359 yards and five touchdowns without an interception for the Bucs, the only team in the NFC that has made the playoffs in each of the past four seasons. “He really played a heck of a ball game, intelligently,” Bowles said. “We didn't turn it over offensively. We were very good on third down. He controlled the ball, spread it around, got everybody touches.” Mayfield threw TD passes of 2 and 1 yards to Mike Evans, and Tampa Bay produced points on five straight first-half possessions to build a 27-7 lead. Jalen McMillan scored on receptions of 10 and 16 yards, linebacker J.J. Russell returned a blocked punt for a third-quarter TD and rookie Bucky Irving had another big game against Carolina with 120 yards rushing on 20 carries and four receptions for 77 yards. “Any time you give him that many opportunities, good things are going to happen,” Mayfield said of Irving. Irving went over 1,000 yards for the season (1,033) despite primarily being used as a backup to Rachaad White. The fourth-round draft pick ran for 152 yards and a touchdown on 25 carries against the NFL's 32nd-ranked run defense in Tampa Bay's 26-23 overtime win at Carolina on Dec. 1. Meanwhile, Mayfield improved to 4-0 against Carolina since his former team released him two years ago. He completed 27 of 32 passes without an interception. The Panthers played without leading rusher Chuba Hubbard, who was placed on injured reserve Saturday. Without him, the offense was almost totally dependent on quarterback Bryce Young, who tossed a pair of TD passes to Adam Thielen but was only 15 of 28 passing for 203 yards. The Bucs sacked Young five times and limited Carolina to 39 yards rushing. Thielen scored on receptions of 17 and 40 yards in the first half and finished with five catches for 110 yards. “We got outplayed. ... They were on fire today. They made it hard for us,” Panthers coach Dave Canales said. “We have one more opportunity to finish, so we have to regroup and have the discipline to go right back to work and finish on our terms.” Evans had eight catches for 97 yards. He needs at least 85 yards receiving in next weekend's regular-season finale to tie Hall of Famer Jerry Rice's NFL record of 11 consecutive seasons with 1,000-plus yards receiving. The Buccaneers played without S Antoine Winfield Jr (knee), TE Cade Otton (knee) and WR Sterling Shepard (hamstring/foot), who were inactive. ... Buccaneers CB Jamel Dean left in the first half with a knee injury and did not return. Panthers: Close the season at the Atlanta Falcons. Buccaneers: Host the New Orleans Saints. Sent weekly directly to your inbox! Sports Editor {{description}} Email notifications are only sent once a day, and only if there are new matching items.
Jaylon Johnson isn't interested in bright spots with the Bears' skid at 5 gamesThese moments defined the life of Jimmy Carter
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