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Sowei 2025-01-13
Interim analysis shows that tecovirimat did not improve time to lesion resolution compared to placebo in adults with mild to moderate clade II mpox Study stopped enrolling patients in all study arms Results affirm tecovirimat's strong safety profile Efficacy in patients with more severe disease not assessed in study NEW YORK, Dec. 10, 2024 (GLOBE NEWSWIRE) -- The National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) today announced results from an interim analysis of the Study of Tecovirimat for Human Mpox Virus (STOMP) clinical trial (NCT05534984). NIAID reported that SIGA's tecovirimat, a highly targeted antiviral treatment, did not demonstrate efficacy in time to skin and mucosal lesion resolution compared to placebo in patients with mild to moderate clade II mpox. Based on this and additional analyses, the study Data Safety and Monitoring Board (DSMB) recommended to stop enrolling patients in the randomized arms of the study. NIAID accepted this recommendation and subsequently decided to take a similar action in the open label arm of this study, which included severe and at-risk of developing severe disease patients. Data analysis is not yet complete for primary endpoint subgroups and detailed secondary and exploratory endpoints. "Antivirals are most effective when administered early in the course of an infection and tend to demonstrate the greatest benefit in patients with more severe disease. The STOMP results are not unexpected as the study design was similar to the PALM007 study except it was in patients with mild to moderate clade II mpox compared to patients with clade I mpox. It is important to note that approximately 75% of mpox patients in the randomized arms of the STOMP trial received tecovirimat more than five days after symptom onset, and higher risk patients were included in an open-label arm," stated Diem Nguyen, Chief Executive Officer. Tecovirimat, also known as TPOXX, was developed in partnership with the U.S. Government and approved by the U.S. Food and Drug Administration to treat smallpox—a virus closely related to, but far more serious than, mpox. TPOXX was approved in 2018 based on data from 12 clinical trials of oral TPOXX in 700 healthy human volunteers, which showed no drug-related serious adverse events. Four pivotal trials in non-human primates (NHPs) and two pivotal trials in rabbits demonstrated that TPOXX significantly reduced both mortality and viral load in NHP infected with mpox virus and in rabbits infected with rabbitpox virus. The results of the animal efficacy studies were published in the July 5, 2018 issue of the New England Journal of Medicine . "Tecovirimat's mechanism of action is driven by halting viral transmission. Once virus is present in the system, the body's natural immune system plays a central role in clearing it, typically within two to four weeks in immune competent patients. Research results thus far indicate that early treatment with tecovirimat including post-exposure prophylaxis and treatment in severe cases may offer the greatest potential for patient benefit," stated Dennis Hruby, Chief Scientific Officer. Additionally, in this study, tecovirimat exhibited a safety profile comparable to placebo. These safety results are consistent with prior studies and further support the strong safety profile that has been observed with tecovirimat over the past 15 years. Dr. Nguyen continued, "We thank our partners, the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institutes of Health (NIH), the patients who participated in this trial, and the investigators who supported this trial. Their unwavering dedication to public health has been instrumental in advancing our understanding of mpox and tecovirimat." Three randomized clinical trials, UNITY (Switzerland, Brazil, Argentina), Platinum-CAN (Canada), and EPOXI (EU), are enrolling mpox patients. Given the STOMP and PALM007 results and the design similarities across these mpox trials, the Company believes these ongoing trials are likely to yield similar results. About the STOMP Clinical Trial in Mpox The STOMP study is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive mpox disease. Beginning in September 2022, the study enrolled participants with mpox from Argentina, Brazil, Japan, Mexico, Peru, Thailand, and the United States, including Puerto Rico, who had symptoms for less than 14 days. Participants were randomly (2:1) assigned to receive tecovirimat or a placebo for 14 days. The number of capsules and frequency of dosage were based on patient weight. Participants with severe disease, certain skin conditions, or significantly suppressed immune systems received open-label tecovirimat rather than being randomized. The study monitored participants' safety across randomized and open label arms. In the randomized arms, STOMP examined the time to full mpox lesion resolution, viral clearance, and study participants' reports of pain. Participants were followed for 28 days with a study site visit at day 29 and then again at day 57 for possible recrudescence of infection. About SIGA SIGA Technologies (SIGA) SIGA is a commercial-stage pharmaceutical company and leader in global health focused on the development of innovative medicines to treat and prevent infectious diseases. With a primary focus on orthopoxviruses, we are dedicated to protecting humanity against the world's most severe infectious diseases, including those that occur naturally, accidentally, or intentionally. Through partnerships with governments and public health agencies, we work to build a healthier and safer world by providing essential countermeasures against these global health threats. Our flagship product, TPOXX® (tecovirimat), is an antiviral medicine approved in the U.S. and Canada for the treatment of smallpox and authorized in Europe and the UK for the treatment of smallpox, mpox (monkeypox), cowpox, and vaccinia complications. For more information about SIGA, visit www.siga.com . Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements relating to the efficacy of tecovirimat to treat mpox in certain patient populations and the results of ongoing mpox clinical studies. Forward-looking statements include statements regarding our future financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations. The words "may," "continue," "estimate," "intend," "plan," "will," "believe," "project," "expect," "seek," "anticipate," "could," "should," "target," "goal," "potential" and similar expressions may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA's actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA's control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the 75A50118C00019 BARDA Contract (the "BARDA Contract"), not to exercise the remaining unexercised option under the BARDA Contract, (ii) the risk that SIGA may not complete performance under the BARDA Contract on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contract or U.S. Department of Defense contracts are modified or canceled at the request or requirement of, or SIGA is not able to enter into new contracts to supply TPOXX to, the U.S. Government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (vi) the risk that target timing for deliveries of product to customers, and the recognition of related revenues, are delayed or adversely impacted by the actions, or inaction, of contract manufacturing organizations, or other vendors, within the supply chain, or due to coordination activities between the customer and supply chain vendors, (vii) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (viii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (ix) the risk that any challenge to SIGA's patent and other property rights, if adversely determined, could affect SIGA's business and, even if determined favorably, could be costly, (x) the risk that regulatory requirements applicable to SIGA's products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking or obtaining needed approvals to market these products, (xi) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA's efforts to develop or market its products, (xii) the risk that changes in domestic or foreign economic and market conditions may affect SIGA's ability to advance its research or may affect its products adversely, (xiii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA's businesses, (xiv) the risk of disruptions to SIGA's supply chain for the manufacture of TPOXX®, causing delays in SIGA's research and development activities, causing delays or the re-allocation of funding in connection with SIGA's government contracts, or diverting the attention of government staff overseeing SIGA's government contracts, (xv) risks associated with actions or uncertainties surrounding the debt ceiling, (xvi) the risk that the U.S. or foreign governments' responses (including inaction) to national or global economic conditions or infectious diseases, are ineffective and may adversely affect SIGA's business, and (xvii) risks associated with responding to an mpox outbreak, as well as the risks and uncertainties included in Item 1A "Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2023 and SIGA's subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read those documents free of charge at the SEC's website at http://www.sec.gov . All such forward-looking statements are current only as of the date on which such statements were made. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events. Contacts: Suzanne Harnett sharnett@siga.com and Investors Media Jennifer Drew-Bear, Edison Group Holly Stevens, Berry & Company Jdrew-bear@edisongroup.com hstevens@berrypr.com © 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.The third and most significant signal of the policy reversal came in the form of a series of policy amendments proposed by a key regulatory body. These amendments, if enacted, would represent a seismic shift in the regulatory landscape, opening up new avenues for growth and innovation while curtailing some of the more rigid restrictions that have been in place for years. The proposed changes have been met with a diverse range of reactions, with some hailing them as a long-overdue step towards economic revitalization, while others express concerns about potential ramifications on social and environmental fronts.wild ace cczz

George Washington 72, Illinois St. 64Georgia quarterback Carson Beck has been ruled out for the second half of Saturday's SEC Championship Game against Texas after being injured on the final play of the first half. Texas' Trey Moore forced a fumble on Beck's pass attempt, appearing to injure the Georgia quarterback's throwing arm. Beck remained motionless on the field for a short time before joining the team in the locker room. Coach Kirby Smart told ESPN at halftime that Beck was done for the day. During the third quarter, Beck was seen with ice on his right elbow. Beck completed 7 of 13 passes for 56 yards and was sacked once before exiting. Georgia backup Gunner Stockton entered and led Georgia on a 10-play, 75-yard opening second-half drive, giving the Bulldogs their first lead at 10-6. Bulldogs punter Brett Thorson injured his left knee in the third quarter and was ruled out of the contest. He was taken off on a cart. --Field Level Media

One of the key drivers behind the outperformance of Chinese concept stocks is the concerted efforts by the Chinese government to stabilize and support the domestic economy. In response to the challenges posed by the COVID-19 pandemic and the global economic downturn, Chinese policymakers have rolled out a series of stimulus measures aimed at boosting consumption, stimulating investment, and ensuring economic stability. These measures have had a positive spillover effect on Chinese concept stocks, boosting investor confidence and driving up valuations.

Title: Graduates from Prestigious University Sentenced to 10 Years for Selling National Secrets

As the first half wore on, the tension in the stadium reached a fever pitch. With both teams creating chances but unable to find the back of the net, it was clear that the match would be decided by a moment of brilliance. And that moment would come from none other than Romelu Lukaku.

In conclusion, the year 2024 proved to be a defining moment for the private banking sector, where survival of the fittest became the norm. As the sector continued to evolve and adapt to the changing market dynamics, only those private banks that were able to innovate, differentiate, and deliver exceptional value to their customers were able to emerge victorious in the battle for survival. The quest for survival in an increasingly competitive environment necessitated a drastic shift in mindset and strategy, ushering in a new era of transformation and growth for the private banking sector.Stock market today: Wall Street inches higher to set more records

Father and son’s $100m marketing start-up bags Airtree as investorGeorgia loses QB Carson Beck (arm) during SEC title game

Title: Herona Coach: The Match Against Liverpool is Worth Enjoying, but Requires Full Effort

Analysis: All the ingredients were there for a 'trap game.' The Steelers baked up a masterpiece PITTSBURGH (AP) — The yard lines weren't the only things lost in the early winter squall that swept off Lake Erie and turned Huntington Bank Stadium into a snow globe on Thursday night. Will Graves, The Associated Press Nov 22, 2024 11:58 AM Nov 22, 2024 12:06 PM Share by Email Share on Facebook Share on X Share on LinkedIn Print Share via Text Message Pittsburgh Steelers quarterback Russell Wilson throws a Hail Mary pass on the final play of the game in the second half of an NFL football game against the Cleveland Browns, Thursday, Nov. 21, 2024, in Cleveland. The Browns won 24-19. (AP Photo/David Richard) PITTSBURGH (AP) — The yard lines weren't the only things lost in the early winter squall that swept off Lake Erie and turned Huntington Bank Stadium into a snow globe on Thursday night. The “good vibes only" mindset that carried the Pittsburgh Steelers through two-plus months of solid if not always spectacular football disappeared in a 24-19 loss to last-place Cleveland . Over three eventful hours, all the ingredients of a classic “trap game” the Steelers (8-3) were hoping to avoid created a recipe with an all-too-familiar aftertaste of regret and missed opportunities,. A bit of immaturity from wide receiver George Pickens, who got into an MMA-style exchange with an opposing defensive back ... again. A pinch of frustration from normally stoic defensive tackle Cam Heyward, who vented afterward about being held on a decisive snap. An ounce — OK, several ounces — of confusion from a coaching staff that couldn't seem to decide whether to accept a late Browns penalty and then compounded it by taking a valuable timeout immediately afterward when the defense couldn't get lined up right. A dash of curious game planning, one that included inserting backup quarterback Justin Fields in high-leverage situations, most notably on third-and-6 with less than 5 minutes to go with the game still in the balance. The gambit that worked beautifully in an emotional victory over Baltimore last Sunday was a decidedly more mixed bag this time around. Add it all up and the result was Pittsburgh's fifth loss in its last seven trips to Cleveland, squandering a chance to move closer to its first AFC North title in four years. “We have a lot of football left,” quarterback Russell Wilson said. “We have a lot of opportunities to respond in the highest way, (the) highest level. I think everything that we want is still in front of us.” Yet a team that's been one of the league's bigger surprises failed to avoid a misstep and provided a reminder that for all the good things it has done of late, the Steelers remain a work in progress. “It is very deflating,” outside linebacker T.J. Watt said. "We need to close out games and we were not able to do that tonight. It sucks that we could not hold on, but a loss is a loss.” What's working Wilson's moonball. Even amid the snowflakes and quick deteriorating conditions, Wilson was unafraid to let the ball fly. Wilson averaged a healthy 12.9 yards per completion, including deep shots to Pickens, Van Jefferson and Calvin Austin III, the last a 23-yard flip to the end zone that Austin cradled to give the Steelers a late lead. If there's one thing that Wilson has shown during his first five starts, it's the situation — be it the score, the down, the time left on the clock or the weather — is immaterial. He will throw it where he wants when he wants, regardless of the circumstance. What needs help The final numbers for the offense — namely 368 yards and 35 minutes of possession — were good. The eye test, however, was another matter. The line had trouble protecting Wilson, giving up four sacks, and generating push when it mattered. Take out a 30-yard sprint by Fields and Pittsburgh averaged less than 3 yards per carry on the ground. The Steelers had the ball with under 5 minutes to go knowing two or three first downs would win in it. So middling runs and one ill-advised pass down the sideline by Fields later, Pittsburgh punted and momentum swung one last time. Stock up Outside linebacker Nick Herbig shows a more than passable T.J. Watt impression when healthy. Herbig's strip-sack of Jameis Winston midway through the fourth quarter set up Austin's go-ahead touchdown. Herbig now had 3 1/2 sacks and three forced fumbles despite missing four games with a hamstring injury. Stock down Pickens displays anger issues, particularly when things don't go his way. The third-year wideout had his third very public, strikingly violent outburst in two months when he got into it with Browns cornerback Greg Newsome III after a last-gasp Hail Mary fell incomplete. The NFL fined Pickens more than $10,000 after he grabbed Dallas defensive back Jourdan Lewis by the facemask at the end of a loss in October. Two weeks ago Pickens and Washington's Mike Sainristil exchanged punches following an interception. The volatile Pickens is by far Pittsburgh's best playmaker. Yet with the stakes likely raised in the coming weeks, he needs to keep his emotions in check if he wants to make sure he stays on the field. Injuries Pittsburgh could have starting outside linebacker Alex Highsmith (ankle) back when they visit Cincinnati on Dec. 1. Highsmith has missed the last two games and five overall this season. Key number 0-8 — head coach Mike Tomlin's career record on the road in Thursday night games against AFC North opponents. Next steps Rest up and prepare for a finishing stretch that starts with a visit to the underperforming but still dangerous Bengals. Pittsburgh swept the season series from Cincinnati last year. ___ AP NFL: https://apnews.com/hub/nfl Will Graves, The Associated Press See a typo/mistake? Have a story/tip? This has been shared 0 times 0 Shares Share by Email Share on Facebook Share on X Share on LinkedIn Print Share via Text Message Get your daily Victoria news briefing Email Sign Up More Football (NFL) Giants release quarterback Daniel Jones just days after benching him Nov 22, 2024 10:18 AM Rams' talented defensive line faces extra challenge in running ability of Eagles QB Jalen Hurts Nov 22, 2024 10:15 AM Week 16 game between Denver Broncos and Los Angeles Chargers flexed to Thursday night spot Nov 22, 2024 8:01 AM

Furthermore, the implementation of the 5-hour workday demonstrates Fat Dong's commitment to innovation and adaptability in the face of changing market dynamics. By embracing new ways of working and reimagining traditional business practices, Fat Dong's sets itself apart as a forward-thinking and customer-centric organization. This commitment to continuous improvement and flexibility positions the business for long-term success in an increasingly competitive marketplace.In conclusion, the story of Mr. and Mrs. Li serves as a powerful reminder that success is not achieved overnight but through perseverance, hard work, and a willingness to overcome obstacles. Their journey from humble beginnings to culinary stardom is a testament to the human spirit's capacity to rise above challenges and carve out a path to success. So let us take inspiration from their story and remember that with a little bit of faith in ourselves and a whole lot of radishes, we too can achieve greatness. Cheers to the power of resilience and the transformative magic of radish meatballs!

New Marvell AI accelerator (XPU) architecture enables up to 25% more compute, 33% greater memory while improving power efficiency. Marvell collaborating with Micron, Samsung and SK hynix on custom high-bandwidth memory (HBM) solutions to deliver custom XPUs. Architecture comprises advanced die-to-die interfaces, HBM base dies, controller logic and advanced packaging for new XPU designs. SANTA CLARA, Calif. , Dec. 10, 2024 /PRNewswire/ -- Marvell Technology, Inc. (NASDAQ: MRVL ), a leader in data infrastructure semiconductor solutions, today announced that it has pioneered a new custom HBM compute architecture that enables XPUs to achieve greater compute and memory density. The new technology is available to all of its custom silicon customers to improve the performance, efficiency and TCO of their custom XPUs. Marvell is collaborating with its cloud customers and leading HBM manufacturers, Micron, Samsung Electronics, and SK hynix to define and develop custom HBM solutions for next-generation XPUs. HBM is a critical component integrated within the XPU using advanced 2.5D packaging technology and high-speed industry-standard interfaces. However, the scaling of XPUs is limited by the current standard interface-based architecture. The new Marvell custom HBM compute architecture introduces tailored interfaces to optimize performance, power, die size, and cost for specific XPU designs. This approach considers the compute silicon, HBM stacks, and packaging. By customizing the HBM memory subsystem, including the stack itself, Marvell is advancing customization in cloud data center infrastructure. Marvell is collaborating with major HBM makers to implement this new architecture and meet cloud data center operators' needs. The Marvell custom HBM compute architecture enhances XPUs by serializing and speeding up the I/O interfaces between its internal AI compute accelerator silicon dies and the HBM base dies. This results in greater performance and up to 70% lower interface power compared to standard HBM interfaces. The optimized interfaces also reduce the required silicon real estate in each die, allowing HBM support logic to be integrated onto the base die. These real-estate savings, up to 25%, can be used to enhance compute capabilities, add new features, and support up to 33% more HBM stacks, increasing memory capacity per XPU. These improvements boost XPU performance and power efficiency while lowering TCO for cloud operators. "The leading cloud data center operators have scaled with custom infrastructure. Enhancing XPUs by tailoring HBM for specific performance, power, and total cost of ownership is the latest step in a new paradigm in the way AI accelerators are designed and delivered," said Will Chu, Senior Vice President and General Manager of the Custom, Compute and Storage Group at Marvell. "We're very grateful to work with leading memory designers to accelerate this revolution and, help cloud data center operators continue to scale their XPUs and infrastructure for the AI era." "Increased memory capacity and bandwidth will help cloud operators efficiently scale their infrastructure for the AI era," said Raj Narasimhan, senior vice president and general manager of Micron's Compute and Networking Business Unit. "Strategic collaborations focused on power efficiency, such as the one we have with Marvell, will build on Micron's industry-leading HBM power specs, and provide hyperscalers with a robust platform to deliver the capabilities and optimal performance required to scale AI." "Optimizing HBM for specific XPUs and software environments will greatly improve the performance of cloud operators' infrastructure and ensure efficient power use," said Harry Yoon , corporate executive vice president of Samsung Electronics and head of Americas products and solutions planning. "The advancement of AI depends on such focused efforts. We look forward to collaborating with Marvell, a leader in custom compute silicon innovation." "By collaborating with Marvell, we can help our customers produce a more optimized solution for their workloads and infrastructure," said Sunny Kang , VP of DRAM Technology, SK hynix America. "As one of the leading pioneers of HBM, we look forward to shaping this next evolutionary stage for the technology." "Custom XPUs deliver superior performance and performance per watt compared to merchant, general-purpose solutions for specific, cloud-unique workloads," said Patrick Moorhead , CEO and Founder of Moor Insights & Strategy. "Marvell, already a player in custom compute silicon, is already delivering tailored solutions to leading cloud companies. Their latest custom compute HBM architecture platform provides an additional lever to enhance the TCO for custom silicon. Through strategic collaboration with leading memory makers, Marvell is poised to empower cloud operators in scaling their XPUs and accelerated infrastructure, thereby paving the way for them to enable the future of AI." Marvell and the M logo are trademarks of Marvell or its affiliates. Please visit www.marvell.com for a complete list of Marvell trademarks. Other names and brands may be claimed as the property of others. This press release contains forward-looking statements within the meaning of the federal securities laws that involve risks and uncertainties. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate or imply future events, results or achievements. Actual events, results or achievements may differ materially from those contemplated in this press release. Forward-looking statements are only predictions and are subject to risks, uncertainties and assumptions that are difficult to predict, including those described in the "Risk Factors" section of our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed by us from time to time with the SEC. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and no person assumes any obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For further information, contact: Kim Markle [email protected] SOURCE MarvellOne of the key risk factors that led to the seizure of Wang Sicong's company is its mounting debt. Despite his high-profile status and connections in the business world, the company has been struggling to meet its financial obligations, leading to legal action by creditors. The 148,000 yuan debt, while relatively small in amount, underscores the broader financial challenges facing Wang Sicong's business empire.

As the countdown to the premiere of "Full Moon Outside the Window, Bang!" begins, anticipation is running high among fans and film enthusiasts who are eagerly awaiting the release of this comedic gem. With its stellar cast, engaging storyline, and expert direction, the film is poised to become a standout comedy hit that will leave a lasting impression on viewers and cement its place as a must-watch film in the Chinese cinema landscape.In conclusion, the significant rise in international oil prices on the 9th of this month highlights the complex interplay of geopolitical, economic, and supply-demand factors that influence the global oil market. As oil prices continue to fluctuate, it is essential for stakeholders to closely monitor developments in the oil market and be prepared to navigate the potential implications of these fluctuations on the global economy.

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