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Evaluating strategic options for iopofosine I 131 a late-stage clinical program with compelling Phase 2 data and a substantial market opportunity Focusing on advancing radiotherapeutic assets including alpha- and Auger-emitting radioconjugates into Phase 1 solid tumor studies FLORHAM PARK, N.J., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announces a strategic update on its clinical development programs for its proprietary phospholipid ether drug conjugate platform that delivers a broad array of therapeutic modalities to target cancers. Due to recent communications with the U.S. Food and Drug Administration (FDA, or the Agency) regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine I 131, the Company has decided to pursue strategic options for the further development and commercialization of this product candidate. The CLOVER-WaM study was conducted in accordance with earlier FDA communications from an end of Phase 2 meeting and from a meeting in early 2024, during which the Company was informed that positive results for major response rate (MRR) as the primary endpoint could be acceptable to support accelerated approval of iopofosine I 131 as a treatment for Waldenstrom’s macroglobulinemia (WM). Based upon a recent Type-C meeting with the FDA, the Company now believes that a submission seeking accelerated approval would need to be based on the MRR data from CLOVER-WaM and enrollment in a randomized, controlled confirmatory study that is designed to generate data on progression-free survival (PFS). “While iopofosine I 131’s positive WM data along with the high unmet medical need for these patients support further investment, we have determined that such a program may best be brought to market by a larger organization with greater resources. Importantly, partnering or divesting this program supports our commitment to providing this potentially life-saving drug to the patients who need it as quickly as possible,” stated James Caruso, president and CEO of Cellectar. “We believe iopofosine I 131 represents a compelling opportunity as it has shown strong efficacy and good tolerability based on our clinical studies. Moreover, the commercial work we conducted demonstrates iopofosine I 131’s substantial market opportunity based upon the product profile, which includes off-the-shelf global distribution, orphan pricing and existing unmet medical need.” Cellectar remains confident in the potential of its phospholipid ether drug conjugate platform and the targeted radiotherapies in its development pipeline. Iopofosine I 131’s clinical success validates the platform’s ability to target cancers and Cellectar will leverage its experience to focus on the development of its earlier clinical programs. Specifically, Cellectar will focus on those assets it believes have the highest therapeutic potential and opportunity for value creation. As highlighted by recent acquisitions and collaborations within the radiopharmaceutical sector, precision isotopes like alpha- and Auger-emitters have emerged as the leading therapeutics of interest. Consequently, the Company will now focus its resources on targeting solid tumors by advancing CLR 121225, its actinium-225 based program, and CLR 121125, its iodine-125 Auger-emitting program into the clinic. Cellectar expects to file Investigational New Drug applications in the first half of 2025 for both CLR-121225 and CLR-121125, which will allow the initiation of Phase 1 clinical studies in solid tumor cancers. Both programs have demonstrated robust in vivo activity, tolerability, excellent targeting and uptake in preclinical solid tumor models. The Company believes this approach will provide an expedited timeframe to achieve safety and proof-of-concept data in patients. The Company’s strategic reprioritization will impact all departments and result in an immediate reduction in headcount of approximately 60%, which should be complete by the end of the fourth quarter 2024. The Company anticipates that the implementation of the restructuring will extend its cash runway into the third quarter of 2025. “We are being methodical in our efforts to reorganize the company with the goal of conserving cash while maintaining the flexibility to execute immediate priorities and build for long-term growth and value creation. This reorganization is difficult but necessary for the future growth potential of Cellectar,” said Mr. Caruso. “I want to extend my deepest gratitude to our departing employees for their significant contributions to our work and their dedication to making a difference in the lives of patients.” About Cellectar Biosciences, Inc. Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug ConjugateTM (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s product pipeline includes lead asset, iopofosine I 131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), CLR 121225, an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer, CLR 121125, an iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal, proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. In addition, iopofosine I 131 is under evaluation in Phase 2b studies for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, alongside the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has also granted iopofosine I 131 Orphan Drug and Fast Track Designations for various cancer indications. New data from the CLOVER-WaM Phase 2 clinical trial were recently presented in an oral presentation at the 66th American Society of Hematology Annual Meeting and Exposition (ASH 2024). For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook. Forward-Looking Statement Disclaimer This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the disruptions at our sole source supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to obtain regulatory exclusivities, the availability of priority review vouchers, our ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K/A for the year ended December 31, 2023, and our Form 10-Q for the quarter ended September 30, 2024. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements. Contacts MEDIA: Christy Maginn Bliss Bio Health 703-297-7194 cmaginn@blissbiohealth.com INVESTORS: Anne Marie Fields Precision AQ 212-362-1200 annemarie.fields@precisionaq.com
In tonight's I'm A Celebrity, all the contestants came together in the main camp tonight as The Junkyard was dismantled, heralding another significant twist on the show. I'm A Celeb enthusiasts saw Love Island star Maura Higgins and the Reverend Richard Coles impress their campmates during today's ordeal, 'The Terrifying Teddy Bears' Picnic', which included gnawing on pig eyes, choking down vomit fruit, and nibbling goat's genitals. The unlikely pair triumphed over the revolting challenge ensuring a hearty "junk banquet" awaited all campers that night. However, before the episode wrapped up, hosts Ant McPartlin and Declan Donnelly had a key update for those at home on ITV . Dec hinted at more action: "We're not quite done yet, we've got one more job for you to do." The beloved Geordie presenters quickly checked-in with their companion programme 'I'm A Celebrity: Unpacked' before revealing what lies ahead. Ant announced: "We need your votes one more time because you need to choose your new camp leaders." Expanding on the details, Dec clarified: "As current camp leaders, Alan and Tulisa are exempt from the vote. "You can vote via the app, the vote closes in about 25 minutes time during the ITV2 show, so you've not got long." Following this news, fans flocked to X, the new iteration of Twitter , to cast their opinions on who ought to take the reins of leadership next. Amid the social media buzz, a user penned: "I am loving Coleen Rooney on #imaceleb she literally works everything out wee #WagathaChristie so funny I want her to be camp leader." A handful of supporters are rallying behind the McFly celebrity, with one user succinctly posting: "Vote Danny for camp leader." In another corner, a fan expressed their sympathy, stating: "Not forgetting how heartbroken #barrymcguigan is and casting all my votes for him to be camp leader and letting him have a little bit of luxury during his time in the jungle." Concurrently, there's a strong wave of support for Maura. One individual recommended voting for her "if you want entertainment," while someone else showed their preference for ex-Strictly star Oti Mabuse, commenting, "Oti camp leader, she's the most level-headed queen." I'm A Celebrity is available to watch on ITV and ITVX.The New York Yankees agreed to a one-year contract worth $5 million with outfielder Trent Grisham on Friday to avoid arbitration, according to ESPN's Jorge Castillo . Per Castillo, Grisham can make an additional $250,000 in bonuses that are tied to plate appearances as part of the deal. The Yankees are also still attempting to re-sign Juan Soto, as the team's meeting with the star outfielder on Monday went "very well" (via Jon Heyman of the New York Post ). This article will be updated soon to provide more information and analysis. For more from Bleacher Report on this topic and from around the sports world, check out our B/R app , homepage and social feeds—including Twitter , Instagram , Facebook and TikTok .You Bet! has sparked quite the reaction from ITV viewers, with many echoing a similar sentiment as they tuned in to watch the new ITV show. The game show, which made its comeback on Saturday evening (December 7) with Holly Willoughby and Stephen Mulhern at the helm, originally enjoyed popularity in the 80s and 90s under the guidance of Bruce Forsyth and Matthew Kelly. The format sees members of the public attempting extraordinary challenges for a chance to win big money, while celebrities bet on their success, raising the stakes with £10,000 on the line. However, despite the excitement of the relaunch, it didn't take long for viewers to voice their opinions online. Many took to social media platform X to express their disappointment with ITV's choice of presenters, suggesting that it's time for new talent to shine, reports the Liverpool Echo . One viewer lamented: "Why couldn't #YouBet on #|TV been presented by some new faces? Why do a few famous #presenters get EVERY show?" (sic) Another chimed in with a call for diversity, saying: "They don't give anyone else a chance... Must be loads of budding presenters waiting for a chance?" A third agreed: "ITV really need to start expanding their pool of presenters..." Fans have been quick to voice their disappointment over the show's decision to axe the original '80s theme tune. One disgruntled viewer said: "Only came for the old theme tune and they've ditched it." Another irritated fan commented: "Already p*****d off for You Bet having a new theme tune." (sic) Meanwhile, another turned the channel in dismay, writing: "Not using the original theme, which was an absolute banger, no hosts banter, no introducing the celebs, turned off within the first minute." Holly had earlier expressed her enthusiasm about the programme, stating, "I'm so excited to be part of this iconic game show with the fabulous Stephen Mulhern. I'm looking forward to seeing the astonishing skills on show from the challengers and which of our celebrity panellists can come out on top." Adding to the excitement, Stephen remarked: "I loved You Bet! as a kid, so I'm very excited to be hosting this with the wonderful Holly Willoughby. From the big and spectacular to the unique and unexpected, I can't wait to see what extraordinary skills the challengers have up their sleeves." Catch up with the first episode of You Bet! on ITVX.
After Trump's Project 2025 denials, he is tapping its authors and influencers for key roles
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HOUSTON (AP) — An elaborate parody appears to be behind an effort to resurrect Enron, the Houston-based energy company that exemplified the worst in American corporate fraud and greed after it went bankrupt in 2001. If its return is comedic, some former employees who lost everything in Enron’s collapse aren’t laughing. “It’s a pretty sick joke and it disparages the people that did work there. And why would you want to even bring it back up again?” said former Enron employee Diana Peters, who represented workers in the company’s bankruptcy proceedings. Here’s what to know about the history of Enron and the purported effort to bring it back. What happened at Enron? Once the nation’s seventh-largest company, Enron filed for bankruptcy protection on Dec. 2, 2001, after years of accounting tricks could no longer hide billions of dollars in debt or make failing ventures appear profitable. The energy company's collapse put more than 5,000 people out of work, wiped out more than $2 billion in employee pensions and rendered $60 billion in Enron stock worthless. Its aftershocks were felt throughout the energy sector. Twenty-four Enron executives , including former CEO Jeffrey Skilling , were eventually convicted for their roles in the fraud. Enron founder Key Lay’s convictions were vacated after he died of heart disease following his 2006 trial. Is Enron coming back? On Monday — the 23rd anniversary of the bankruptcy filing — a company representing itself as Enron announced in a news release that it was relaunching as a “company dedicated to solving the global energy crisis.” It also posted a video on social media, advertised on at least one Houston billboard and a took out a full-page ad in the Houston Chronicle In the minute-long video that was full of generic corporate jargon, the company talks about “growth” and “rebirth.” It ends with the words, “We’re back. Can we talk?” Enron's new website features a company store, where various items featuring the brand's tilted “E” logo are for sale, including a $118 hoodie. In an email, company spokesperson Will Chabot said the new Enron was not doing any interviews yet, but that "We’ll have more to share soon.” Signs point to the comeback being a joke. In the “terms of use and conditions of sale” on the company's website, it says “the information on the website about Enron is First Amendment protected parody, represents performance art, and is for entertainment purposes only.” Documents filed with the U.S. Patent and Trademark Office show that College Company, an Arkansas-based LLC, owns the Enron trademark. The co-founder of College Company is Connor Gaydos, who helped create a joke conspiracy theory that claims all birds are actually surveillance drones for the government. What do former Enron employees think of the company’s return? Peters said that since learning about the “relaunch” of Enron, she has spoken with several other former employees and they are also upset by it. She said the apparent stunt was “in poor taste.” “If it’s a joke, it’s rude, extremely rude. And I hope that they realize it and apologize to all of the Enron employees,” Peters said. Peters, who is 74 years old, said she is still working in information technology because “I lost everything in Enron, and so my Social Security doesn’t always take care of things I need done.” “Enron’s downfall taught us critical lessons about corporate ethics, accountability, and the consequences of unchecked ambition. Enron’s legacy was the employees in the trenches. Leave Enron buried,” she said. ___ Follow Juan A. Lozano on X at https://x.com/juanlozano70 Juan A. Lozano, The Associated PressUMass football: Amid coaching search, pair of blunders has athletic department in the spotlight
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