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ISLAMABAD, (UrduPoint / Pakistan Point News - 26th Nov, 2024) Minister for Planning and Development on Monday said that Tehreek e Insaf ( ), is playing political tactics to gain personal interest. PTI had been involved in attacking security institutions on 9, he said while talking to a private channel. Ali Amin Gandapur is utilizing official resources of Khyber Pakhtunkhawa for creating trouble in the Center, he said. The law enforcement institutions are fully to take action against any violators, he warned. In reply to a question about dialogue with , he said the always tried to hold talks with leaders but they refused to go forward. We never closed the doors for dialogue but leaders didn’t show any sincerity for talks, he said. To another question about release of the founder of , he said founder is facing charges including 9 , and the courts will decide the cases of . He said that will not allow to spread unrest through public rallies or halt activity by arranging demonstration anywhere. Commenting on rule in , he said the has failed to resolve the people's problems and constitutional options are available to address genuine issues of the province. We want to make a modern economic state and for this, no hindrance would be tolerated at any , he stated.Article content The Edmonton Metropolitan Region Board (EMRB) will no longer receive funding from the Alberta government starting next year. “The news was sudden. It was unexpected,” said EMRB chair, Allan Gamble in an interview with Postmedia Monday. On Friday, Municipal Affairs Minister Ric McIver told the board that the Alberta government would no longer provide provincial funding for the group starting in the 2025 budget. The news comes shortly after Calgary heard that its own metropolitan regional board (CMRB) would also be losing its funding from the province. McIver also informed the EMRB that along with axing provincial funding, membership would be voluntary as opposed to mandatory, moving forward. The EMRB is a cooperative group of 13 municipalities surrounding Edmonton that collaborate to ensure broad benefits to the region. The board is comprised of Parkland Country, Spruce Grove, Beaumont, Devon, Edmonton, Fort Saskatchewan, Leduc, Leduc County, Morinville, St. Albert, Stony Plain, Strathcona County, and Sturgeon County. ‘The death of this organization’: Knack Edmonton ward Nakota Isga Coun. Andrew Knack said cutting funding for the EMRB is one of the most harmful decisions the Alberta government can make for municipalities, saying the province is overstepping its jurisdiction. “This is a group that constantly says they do not want federal overreach into provincial affairs and then subsequently goes out of their way to do provincial overreach into the affairs of municipalities,” Knack said Friday, adding the decision doesn’t bode well for the future of the organization. “We know this is essentially the death of this organization. I think it would be such a loss.” For its part, Gamble said “given the sadness of this decision,” the EMRB will “take a few days to meet and discuss a plan for the future.” Gamble said despite the province’s mandate, the municipality cooperation was primarily spurred by its benefits to the region. “We work together, not because the provincial government mandated us to do so, but because we understand the immense value of our work and how critical it is to the region’s future,” said Gamble. Knack highlighted the role that the EMRB played over the past few years, pointing to the regional growth plan, passed last term. By working together on land use and service planning, Knack said the region saved 250 quarter sections for premium agricultural farmland and more than $5 billion in infrastructure costs that would have been incurred as a region if those lands were developed. Knack said at a time when other regional entities haven’t been successful, the EMRB has been a “shining example” of regional collaboration. “They have been working together on economic development, on so many areas showing why there is value in municipalities coming together to work together, to support one another,” he said, adding what happens in Edmonton impacts the region and vice versa. It has shown “how we can all come together, and even with our differences find ways to move forward and recognize that when we’re working together we’re going to be a much more successful region than if we kept trying to go it each alone.” Gamble said the 13 member municipalities are committed to moving forward together and will continue to collaborate as one to develop “coordinated approaches to transportation, infrastructure, agricultural lands, municipal services, the environment, and more. “Given this, our partnership with the Government of Alberta has provided great value to both the region and the province, so we’re remaining committed to working with them to find a new way forward,” said Gamble. – With files from Lauren Boothby zdelaney@postmedia.comATLANTA , Dec. 12, 2024 /PRNewswire/ -- Cousins Properties Incorporated (the "Company" or "Cousins") (NYSE:CUZ) announced today that its operating partnership, Cousins Properties LP (the "Operating Partnership"), has priced an offering of $400 million aggregate principal amount of 5.375% senior unsecured notes due 2032 at 99.463% of the principal amount. The offering is expected to close on December 17, 2024 , subject to the satisfaction of customary closing conditions. Cousins intends to use the net proceeds from the offering to fund a portion of the purchase price of 601 West 2nd Street, also known as Sail Tower, an 804,000 square foot trophy lifestyle office property in Austin (the "Sail Tower Acquisition"), and the remainder to repay borrowings under its credit facility and for general corporate purposes. In the event the Sail Tower Acquisition is not completed, Cousins will use the net proceeds from the offering for general corporate purposes, including the acquisition and development of office properties, other opportunistic investments and the repayment of debt. The notes will be fully and unconditionally guaranteed on a senior unsecured basis by the Company. J.P. Morgan, Truist Securities, US Bancorp, BofA Securities, Morgan Stanley, PNC Capital Markets LLC, TD Securities and Wells Fargo Securities are acting as joint book-running managers. A shelf registration statement relating to these securities is effective with the Securities and Exchange Commission. The offering may be made only by means of a prospectus supplement and accompanying prospectus. Copies of these documents may be obtained by contacting J.P. Morgan Securities LLC, 383 Madison Avenue, New York, New York , 10179, Attention: Investment Grade Syndicate Desk, 3rd Floor, telephone collect at 1-212-834-4533; Truist Securities, Inc., Attention: Prospectus Department, 303 Peachtree Street, Atlanta, GA 30308, telephone: 800-685-4786, or e-mail: TruistSecurities.prospectus@Truist.com ; or U.S. Bancorp Investments, Inc., Attention: High Grade Syndicate, 214 North Tryon Street, 26th Floor, Charlotte, NC 28202, or by telephone at: (877) 558-2607. Electronic copies of these documents are also available from the Securities and Exchange Commission's website at www.sec.gov . This press release is neither an offer to purchase nor a solicitation of an offer to sell the notes, nor shall it constitute an offer, solicitation or sale in any state or jurisdiction in which such offer, solicitation or sale is unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Cousins Properties Cousins Properties is a fully integrated, self-administered and self-managed real estate investment trust ("REIT"). The Company, based in Atlanta, GA and acting through the Operating Partnership, primarily invests in Class A office buildings located in high growth Sun Belt markets. Founded in 1958, Cousins creates shareholder value through its extensive expertise in the development, acquisition, leasing, and management of high-quality real estate assets. The Company has a comprehensive strategy in place based on a simple platform, trophy assets, and opportunistic investments. Forward-Looking Statements Certain matters contained in this press release are "forward-looking statements" within the meaning of the federal securities laws and are subject to uncertainties and risks, as itemized in Item 1A included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023 and in the Company's Quarterly Reports on Form 10-Q for the quarters ended June 30, 2024 and September 30, 2024 . These forward-looking statements include information about the Company's possible or assumed future results of the business and the Company's financial condition, liquidity, results of operations, plans, and objectives. They also include, among other things, statements regarding subjects that are forward-looking by their nature, such as: guidance and underlying assumptions; business and financial strategy; future debt financings; future acquisitions and dispositions of operating assets or joint venture interests; future acquisitions and dispositions of land, including ground leases; future acquisitions of investments in real estate debt; future development and redevelopment opportunities; future issuances and repurchases of common stock, limited partnership units, or preferred stock; future distributions; projected capital expenditures; market and industry trends; future occupancy or volume and velocity of leasing activity; entry into new markets, changes in existing market concentrations, or exits from existing markets; future changes in interest rates and liquidity of capital markets; and all statements that address operating performance, events, investments, or developments that we expect or anticipate will occur in the future — including statements relating to creating value for stockholders. Any forward-looking statements are based upon management's beliefs, assumptions, and expectations of our future performance, taking into account information that is currently available. These beliefs, assumptions, and expectations may change as a result of possible events or factors, not all of which are known. If a change occurs, our business, financial condition, liquidity, and results of operations may vary materially from those expressed in forward-looking statements. Actual results may vary from forward-looking statements due to, but not limited to, the following: the availability and terms of capital and our ability to obtain and maintain financing arrangements on terms favorable to us or at all; the ability to refinance or repay indebtedness as it matures; any changes to our credit rating; the failure of purchase, sale, or other contracts to ultimately close; the failure to achieve anticipated benefits from acquisitions, developments, investments, or dispositions; the effect of common stock or operating partnership unit issuances, including those undertaken on a forward basis, which may negatively affect the market price of our common stock; the availability of buyers and pricing with respect to the disposition of assets; changes in national and local economic conditions, the real estate industry, and the commercial real estate markets in which we operate (including supply and demand changes), particularly in Atlanta , Austin , Tampa , Charlotte , Phoenix , Dallas , and Nashville , including the impact of high unemployment, volatility in the public equity and debt markets, and international economic and other conditions; threatened terrorist attacks or sociopolitical unrest such as political instability, civil unrest, armed hostilities, or political activism, which may result in a disruption of day-to-day building operations; changes to our strategy in regard to our real estate assets may require impairment to be recognized; leasing risks, including the ability to obtain new tenants or renew expiring tenants, the ability to lease newly-developed and/or recently acquired space, the failure of a tenant to commence or complete tenant improvements on schedule or to occupy leased space, and the risk of declining leasing rates; changes in the preferences of our tenants brought about by the desire for co-working arrangements, trends toward utilizing less office space per employee, and the effect of employees working remotely; any adverse change in the financial condition or liquidity of one or more of our tenants or borrowers under our real estate debt investments; volatility in interest rates (including the impact upon the effectiveness of forward interest rate contract arrangements) and insurance rates; inflation; competition from other developers or investors; the risks associated with real estate developments (such as zoning approval, receipt of required permits, construction delays, cost overruns, and leasing risk); supply chain disruptions, labor shortages, and increased construction costs; risks associated with security breaches through cyberattacks, cyber intrusions or otherwise, as well as other significant disruptions of our information technology networks and related systems, which support our operations and our buildings; changes in senior management, changes in the Company's board of directors, and the loss of key personnel; the potential liability for uninsured losses, condemnation, or environmental issues; the potential liability for a failure to meet regulatory requirements, including the Americans with Disabilities Act and similar laws or the impact of any investigation regarding the same; the financial condition and liquidity of, or disputes with, joint venture partners; any failure to comply with debt covenants under debt instruments and credit agreements; any failure to continue to qualify for taxation as a real estate investment trust or meet regulatory requirements; potential changes to state, local, or federal regulations applicable to our business; material changes in dividend rates on common shares or other securities or the ability to pay those dividends; potential changes to the tax laws impacting real estate investment trusts and real estate in general; risks associated with climate change and severe weather events, as well as the regulatory efforts intended to reduce the effects of climate changes and investor and public perception of our efforts to respond to the same; the impact of newly adopted accounting principles on our accounting policies and on period-to-period comparisons of financial results; risks associated with possible federal, state, local, or property tax audits; and those additional risks and environmental or other factors discussed in reports filed with the Securities and Exchange Commission by the Company. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company cannot guarantee the accuracy of any such forward-looking statements contained in this press release, and the Company does not intend to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts Roni Imbeaux Vice President, Finance and Investor Relations 404-407-1104 rimbeaux@cousins.com View original content: https://www.prnewswire.com/news-releases/cousins-properties-announces-pricing-of-senior-notes-offering-302330787.html SOURCE Cousins Properties
Facebook Twitter WhatsApp SMS Email Print Copy article link Save The U.S. Navy is transforming a costly flub into a potent weapon with the first shipborne hypersonic weapon, which is being retrofitted aboard the first of its three stealthy destroyers. The USS Zumwalt is at a Mississippi shipyard where workers have installed missile tubes that replace twin turrets from a gun system that was never activated because it was too expensive. Once the system is complete, the Zumwalt will provide a platform for conducting fast, precision strikes from greater distances, adding to the usefulness of the warship. The USS Zumwalt is seen at the Huntington Ingalls shipyard Nov. 21 in Pascagoula, Miss. “It was a costly blunder. But the Navy could take victory from the jaws of defeat here, and get some utility out of them by making them into a hypersonic platform,” said Bryan Clark, a defense analyst at the Hudson Institute. The U.S. has had several types of hypersonic weapons in development for the past two decades, but recent tests by both Russia and China have added pressure to the U.S. military to hasten their production. People are also reading... The real reason Corvallis' Pastega Lights moved to Linn County Corvallis chemical manufacturer eyes Albany for expansion UPDATED: GAPS teacher strike NOT off after talks over returning to the classroom break down Recently made-over park sees this change after Albany got an earful Corvallis decides layout for new civic campus — with a side of strife Agreement reached (again), GAPS teachers get new contract Albany man pleads to numerous sex crimes Strike to end, GAPS reaches tentative deal with Albany teachers Philomath moves forward following July Nazi flag controversy Court dismisses jail-related Benton County whistleblower complaint 2025 to bring rate increases, new fee for hauling Corvallis waste Corvallis woman cuts hair for homeless: 'The Lord gave me a calling' OSU football: Beavers add 18 players as signing period opens Family objects to Jefferson man’s sex offense sentence A false start: GAPS strike continues after district, teachers announce deal Hypersonic weapons travel beyond Mach 5, five times the speed of sound, with added maneuverability making them harder to shoot down. Last year, The Washington Post reported that among the documents leaked by former Massachusetts Air National Guard member Jack Teixeira was a defense department briefing that confirmed China had recently tested an intermediate-range hypersonic weapon called the DF-27. While the Pentagon previously acknowledged the weapon's development, it had not recognized its testing. One of the U.S. programs in development and planned for the Zumwalt is the “Conventional Prompt Strike." It would launch like a ballistic missile and then release a hypersonic glide vehicle that would travel at speeds seven to eight times faster than the speed of sound before hitting the target. The weapon system is being developed jointly by the Navy and Army. Each of the Zumwalt-class destroyers would be equipped with four missile tubes, each with three of the missiles for a total of 12 hypersonic weapons per ship. In choosing the Zumwalt, the Navy is attempting to add to the usefulness of a $7.5 billion warship that is considered by critics to be an expensive mistake despite serving as a test platform for multiple innovations. The USS Zumwalt is seen at the Huntington Ingalls shipyard Nov. 21 in Pascagoula, Miss. The Zumwalt was envisioned as providing land-attack capability with an Advanced Gun System with rocket-assisted projectiles to open the way for Marines to charge ashore. But the system featuring 155 mm guns hidden in stealthy turrets was canceled because each of the rocket-assisted projectiles cost between $800,000 and $1 million. Despite the stain on its reputation, the three Zumwalt-class destroyers remain the Navy’s most advanced surface warship in terms of new technologies. Those innovations include electric propulsion, an angular shape to minimize radar signature, an unconventional wave-piercing hull, automated fire and damage control and a composite deckhouse that hides radar and other sensors. The Zumwalt arrived at the Huntington Ingalls Industries shipyard in Pascagoula, Mississippi, in August 2023 and was removed from the water for the complex work of integrating the new weapon system. It is due to be undocked this week in preparation for the next round of tests and its return to the fleet, shipyard spokeswoman Kimberly Aguillard said. A U.S. hypersonic weapon was successfully tested over the summer and development of the missiles is continuing. The Navy wants to begin testing the system aboard the Zumwalt in 2027 or 2028, according to the Navy. The U.S. weapon system will come at a steep price. It would cost nearly $18 billion to buy 300 of the weapons and maintain them over 20 years, according to the Congressional Budget Office. Critics say there is too little bang for the buck. “This particular missile costs more than a dozen tanks. All it gets you is a precise non-nuclear explosion, some place far far away. Is it really worth the money? The answer is most of the time the missile costs much more than any target you can destroy with it,” said Loren Thompson, a longtime military analyst in Washington, D.C. US Navy intercepts Houthi missiles aimed at American ships in Gulf of Aden The U.S. Navy intercepted Houthi missiles and drones targeting two warships and three merchant vessels in the Gulf of Aden. But they provide the capability for Navy vessels to strike an enemy from a distance of thousands of kilometers — outside the range of most enemy weapons — and there is no effective defense against them, said retired Navy Rear Adm. Ray Spicer, CEO of the U.S. Naval Institute, an independent forum focusing on national security issues, and former commander of an aircraft carrier strike force. Conventional missiles that cost less aren’t much of a bargain if they are unable to reach their targets, Spicer said, adding the U.S. military really has no choice but to pursue them. “The adversary has them. We never want to be outdone,” he said. The U.S. is accelerating development because hypersonics have been identified as vital to U.S. national security with “survivable and lethal capabilities,” said James Weber, principal director for hypersonics in the Office of the Assistant Secretary of Defense for Critical Technologies. “Fielding new capabilities that are based on hypersonic technologies is a priority for the defense department to sustain and strengthen our integrated deterrence, and to build enduring advantages,” he said. Rising Costs Hit Military Families Hard: Here’s How You Can Help Rising Costs Hit Military Families Hard: Here’s How You Can Help Image Credit: Jacob Lund / Shutterstock The financial challenges facing U.S. military households are a significant concern throughout the year. Holidays such as Memorial Day, Armed Forces Day, or Veterans Day highlight the ongoing struggles that service members face, particularly amid rising costs for everyday essentials. Recent data from the U.S. Census Bureau’s Household Pulse Survey shows a troubling trend: Military personnel and their families are finding it more difficult to cover basic household expenses such as food, housing, and transportation than the average American. Our analysis examines how service members are faring in today’s economy compared to civilian households, highlighting the states where military families report the greatest challenges in managing their finances. As we enter Giving Season, we’ve also highlighted meaningful ways to support service members and their families through charitable contributions, offering an opportunity to make a direct impact on those who serve our nation. Financial Challenges Facing Service Members Service members are struggling more financially than the average American. Image Credit: Upgraded Points According to recent Household Pulse Survey data, members of the armed services are experiencing financial strain at higher rates than the general U.S. population. Over 40% of service members report difficulty covering their usual household expenses, compared to 36.6% of all U.S. adults. The data also shows heightened anxiety among service members regarding rising prices. Nearly 80% of military personnel express stress about recent price increases, significantly higher than the 71.8% of all U.S. adults who share similar feelings. Furthermore, 81.8% of service members are concerned about future price hikes, reflecting widespread uncertainty about inflation’s long-term impact on household budgets. States Where Service Members Struggle To Cover Costs More than half of service members in certain states have difficulty covering basic household expenses. Image Credit: Upgraded Points Across the U.S., the financial burden on service members varies significantly from state to state, primarily influenced by local economic conditions. According to the most recent data, Utah leads with 53.7% of service members reporting difficulty covering basic household expenses, closely followed by Louisiana (52.9%) and Alaska (52.8%). Other states where over half of service members are struggling include Indiana (52.0%), Tennessee (51.2%), New York (50.8%), and Florida (50.3%). A key issue service members frequently raise is that their Basic Allowance for Housing (BAH) has not kept pace with the rapidly rising cost of housing. In states where service members face the greatest financial difficulties, such as Utah, Indiana, Tennessee, and Florida, home price increases have far exceeded the national average, exacerbating the strain on household budgets. Another critical factor affecting military families is the employment challenges military spouses face. According to the Department of Defense, the military spouse unemployment rate was 21% in 2023, compared to a national rate of 3.6% that year. Many military bases are located in rural or remote areas, limiting job opportunities for spouses, particularly in specialized fields. Additionally, frequent relocations make it difficult for spouses to sustain long-term careers, especially for those in professions requiring state-specific occupational licenses that can be difficult to transfer. Service members are also more likely to report financial struggles in states with higher-than-average unemployment rates, such as Louisiana, Alaska, and New York. Conversely, the state unemployment rate is below average in 9 of the 10 states where service members report the least financial difficulty. This suggests that strong local employment opportunities, particularly for spouses, significantly ease the financial burden on military households. How You Can Help: Top Military and Veteran Charities Photo Credit: Bumble Dee / Shutterstock One of the most impactful ways to support service members, veterans, and their families who are facing financial hardships is through donations to reputable charities. These organizations are dedicated to addressing the unique challenges faced by military families and veterans, providing vital assistance in areas like housing, medical expenses, scholarships, and career training. To help guide your generosity, we’ve compiled a list of top-rated charities based on scores from Charity Navigator , CharityWatch , and GuideStar , which assess organizations on criteria such as impact, efficiency, accountability, and transparency. Here are some of the best charities supporting military families and veterans in need: 1. USO For over 80 years, the USO has provided crucial support to active-duty service members and their families. From financial assistance programs to community-building initiatives, the USO helps service members stay connected to loved ones while addressing their most pressing needs during deployments and transitions. 2. Homes For Our Troops This charity is focused on providing specially adapted homes for severely injured post-9/11 veterans. It helps veterans regain independence. Homes For Our Troops also provides financial planning and household budgeting to ensure long-term stability for the recipients. 3. Iraq and Afghanistan Veterans of America (IAVA) Dedicated to advocating for veterans of the Iraq and Afghanistan wars, IAVA works to improve government policies and programs that support military families. Its advocacy ensures veterans have access to financial resources, healthcare, and education opportunities. 4. Fisher House Foundation This foundation builds “comfort homes” near military and VA medical centers, allowing families to stay free of charge while a loved one is hospitalized. By reducing travel and lodging expenses, Fisher House eases financial stress during difficult times. 5. Hope For The Warriors Offering a range of programs focused on financial stability, wellness, social support, and education, Hope For The Warriors provides critical support to service members, veterans, and their families. Its services include direct financial assistance for transitioning service members and veterans in need, career training and job placement, and scholarships for spouses. 6. Semper Fi & America’s Fund Semper Fi & America’s Fund assists wounded, ill, and injured service members and their families through direct financial assistance and case management during hospitalization and recovery. The organization also provides educational support, career assistance, and health and wellness services. 7. Wounded Warriors Family Support (WWFS) WWFS supports families of those wounded or killed in combat through programs like medical travel grants, meal and housekeeping assistance, in-home care services, and family retreats. By addressing these families' immediate and ongoing needs, WWFS alleviates the financial burdens of those suffering from recent tragic events. For more information, a detailed methodology, and complete results, see Rising Costs Hit Military Families Hard: Here’s How You Can Help on Upgraded Points . Methodology Photo Credit: Jacob Lund / Shutterstock Upgraded Points conducted the analysis using the latest data from the U.S. Census Bureau Household Pulse Survey Phase 4.0–4.2 , covering the period from January 9, 2024, to September 16, 2024. Service members were defined as adults currently serving in the U.S. armed forces (Active Duty, Reserve, or National Guard) and their spouses. This analysis focuses on 3 key questions from the survey: Difficulty Covering Household Expenses: Respondents were asked, "In the last 7 days, how difficult has it been for your household to pay for usual household expenses, including but not limited to food, rent or mortgage, car payments, medical expenses, student loans, and so on?" We defined difficulty as either "very difficult" or "somewhat difficult.” Stress Due to Price Increases: Respondents were asked, "How stressful, if at all, has the increase in prices in the last two months been for you?" We defined stress as either "very stressful" or "moderately stressful." Concern About Future Price Increases: Finally, respondents were asked, "In the area you live and shop, how concerned are you, if at all, that prices will increase in the next 6 months?" We defined concern as either "very concerned" or "somewhat concerned." Statistics with fewer than 50 survey responses were omitted from the analysis. Additional statistics on home prices were sourced from Zillow’s Home Value Index , and unemployment rates were sourced from the U.S. Census Bureau’s 2023 American Community Survey 1-Year Estimates . For complete results, see Rising Costs Hit Military Families Hard: Here’s How You Can Help on Upgraded Points. Get local news delivered to your inbox!
NATO and Ukraine to hold emergency talks after Russian attack with hypersonic missileCARLSBAD, Calif. , Dec. 19, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved TRYNGOLZATM (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), a rare, genetic form of severe hypertriglyceridemia (sHTG) that can lead to potentially life-threatening acute pancreatitis (AP). TRYNGOLZA is the first-ever FDA-approved treatment that significantly and substantially reduces triglyceride levels in adults with FCS and provides clinically meaningful reduction in AP events when used with an appropriate diet (≤20 grams of fat per day). TRYNGOLZA is self-administered via an auto-injector once monthly. Experience the full interactive Multichannel News Release here: https://www.multivu.com/ionis-pharmaceuticals/9295551-en-tryngolza-olezarsen-fda-approval "Today's FDA approval of TRYNGOLZA heralds the arrival of the first-ever FCS treatment in the U.S. – a transformational moment for patients and their families. For the first time, adults with FCS can now access a treatment that substantially reduces triglycerides and the risk of debilitating and potentially life-threatening acute pancreatitis," said Brett P. Monia , Ph.D., chief executive officer, Ionis. "We are proud of our long-standing partnership with the FCS community and are grateful to the patients, families and investigators who participated in our clinical studies, enabling Ionis to make this new treatment a reality. The FDA approval of TRYNGOLZA is also a pivotal moment for Ionis, representing our evolution into a fully integrated commercial-stage biotechnology company – a goal we set out to achieve five years ago. With our rich pipeline of potentially life-changing medicines, we expect TRYNGOLZA to be the first in a steady cadence of innovative medicines we will deliver independently to people living with serious diseases." The FDA approval was based on positive data from the global, multicenter, randomized, placebo-controlled, double-blind Phase 3 Balance clinical trial in adult patients with genetically identified FCS and fasting triglyceride levels ≥880 mg/dL. In the Balance study, TRYNGOLZA 80 mg demonstrated a statistically significant placebo-adjusted mean reduction in triglyceride levels of 42.5% from baseline to six months (p=0.0084). Reductions from baseline to 12 months were further improved, with TRYNGOLZA achieving a placebo-adjusted 57% mean reduction in triglycerides. TRYNGOLZA also demonstrated a substantial, clinically meaningful reduction in AP events over 12 months; one patient (5%) experienced one episode of AP in the TRYNGOLZA group compared with seven patients (30%) who experienced 11 total episodes of AP in the placebo group. TRYNGOLZA demonstrated a favorable safety profile. The most common adverse reactions (incidence >5% of TRYNGOLZA-treated patients and at a >3% higher frequency than placebo) were injection site reactions (19% and 9%, respectively), decreased platelet count (12% and 4%, respectively) and arthralgia (9% and 0%, respectively). Results from the Phase 3 Balance study were previously published in The New England Journal of Medicine (NEJM). "With no treatment options previously available, we were limited to relying only on extremely strict diet and lifestyle changes as the sole preventative treatment option," said Alan Brown , M.D., FNLA, FACC, FAHA, clinical professor of medicine, Rosalind Franklin University of Medicine and Science ; Balance trial investigator. "The FDA approval of TRYNGOLZA is an important moment for people living with FCS, their families and physicians who now, for the first time, have a treatment that significantly lowers triglycerides and decreases the risk of potentially life-threatening acute pancreatitis events, as an adjunct to a low-fat diet. I am excited to have a medicine I can prescribe to my patients that has been shown to change the course of their disease." FCS is a rare, genetic, potentially life-threatening form of sHTG that prevents the body from breaking down fats and severely impairs the body's ability to remove triglycerides from the bloodstream due to an impaired function of the enzyme lipoprotein lipase (LPL). While healthy levels for adults are below 150 mg/dL, people with FCS often have triglyceride levels of more than 880 mg/dL and often have a history of pancreatitis. Those living with FCS have a high risk of potentially fatal AP, which is a painful inflammation of the pancreas, and chronic health issues such as fatigue and severe, recurrent abdominal pain. People living with FCS can also experience psychological and financial stress, which can significantly impact their quality of life. In the U.S., FCS is estimated to impact up to approximately 3,000 people, the vast majority of whom remain undiagnosed. "As a rare and difficult to diagnose disease, FCS has a profound impact on the lives of patients and families. Many people living with FCS have experienced severe pain their whole lives – sometimes so intense they require lengthy hospitalization stays – and struggle through life with daily fatigue, nausea, brain fog and stomach pain," said Lindsey Sutton Bryan , co-founder and co-president, FCS Foundation. "Until now, our treatment options have been limited, relying on diet alone to try to manage triglyceride levels and keep acute pancreatitis attacks at bay. For the first time, adults with FCS have seen their hope for a treatment become a reality." TRYNGOLZA will be available in the U.S. before year end. Ionis is committed to helping people access the medicines they are prescribed and will offer a suite of services designed to meet the unique needs of the FCS community through Ionis Every StepTM. As part of Ionis Every Step , patients and healthcare providers will have access to services throughout the treatment journey provided by dedicated Patient Education Managers and Ionis Every Step Case Managers, including insurance and affordability support, as well as services and resources, such as disease and nutrition education. Visit TRYNGOLZA.com for more information. TRYNGOLZA was reviewed by the FDA under Priority Review and had previously been granted Fast Track designation for the treatment of FCS, Orphan Drug designation and Breakthrough Therapy designation. Olezarsen is undergoing review in the European Union and regulatory filings in other countries are planned. Olezarsen is currently being evaluated in three Phase 3 clinical trials – CORE, CORE2 and ESSENCE – for the treatment of sHTG. Olezarsen has not been reviewed or approved for the treatment of sHTG by regulatory authorities. Webcast Ionis will hold a webcast today at 6:45pm ET to discuss the FDA approval. Interested parties may access the webcast here . A webcast replay will be available for a limited time. About TRYNGOLZATM (olezarsen) TRYNGOLZATM (olezarsen) was approved by the U.S. Food and Drug Administration as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). TRYNGOLZA is an RNA-targeted medicine designed to lower the body's production of apoC-III, a protein produced in the liver that is a key regulator of triglyceride metabolism. It is the only treatment currently indicated in the U.S. for FCS, a potentially life-threatening disease. For more information about TRYNGOLZA, visit TRYNGOLZA.com . IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS TRYNGOLZA is contraindicated in patients with a history of serious hypersensitivity to TRYNGOLZA or any of the excipients in TRYNGOLZA. Hypersensitivity reactions requiring medical treatment have occurred. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Hypersensitivity reactions (including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills and myalgias) have been reported in patients treated with TRYNGOLZA. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to promptly seek medical attention and discontinue use of TRYNGOLZA if hypersensitivity reactions occur. ADVERSE REACTIONS The most common adverse reactions (incidence >5% of TRYNGOLZA-treated patients and >3% higher frequency than placebo) were injection site reactions, decreased platelet count and arthralgia. Please see full Prescribing Information for TRYNGOLZA. About Familial Chylomicronemia Syndrome (FCS) FCS is a rare, genetic disease characterized by extremely elevated triglyceride levels. It is caused by impaired function of the enzyme lipoprotein lipase (LPL). Because of limited LPL production or function, people with FCS cannot effectively break down chylomicrons, lipoprotein particles that are 90% triglycerides. FCS is estimated to impact up to approximately 3,000 people in the U.S. People living with FCS are at high risk of acute pancreatitis (AP) in addition to other chronic health issues such as fatigue and severe, recurrent abdominal pain. People living with FCS are sometimes unable to work, adding to the burden of disease. About the Balance Study Balance is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of olezarsen in patients with FCS at six and 12 months. The primary endpoint was the percent change from baseline in fasting triglyceride levels at six months compared to placebo. Secondary endpoints included percent changes in triglyceride levels at 12 months, percent changes in other lipid parameters and adjudicated acute pancreatitis event rates over the treatment period. Following treatment and the end-of-trial assessments, patients were eligible to enter an open-label extension study to continue receiving olezarsen once every four weeks. About Ionis Pharmaceuticals, Inc. For three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis has discovered and developed six marketed medicines for serious diseases, including breakthrough medicines for neurologic and cardiovascular diseases. Ionis has a leading pipeline in neurology, cardiology and other areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients. To learn more about Ionis, visit Ionis.com and follow us on X (Twitter) , LinkedIn and Instagram . Ionis Forward-Looking Statements This press release includes forward-looking statements regarding Ionis' business and the therapeutic and commercial potential of TRYNGOLZA, Ionis' technologies and other products in development. Any statement describing Ionis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including but not limited to those related to our commercial products and the medicines in our pipeline, and particularly those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. Except as required by law, we undertake no obligation to update any forward-looking statements for any reason. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis' programs are described in additional detail in Ionis' annual report on Form 10-K for the year ended Dec. 31, 2023 , and most recent Form 10-Q, which are on file with the SEC. Copies of these and other documents are available at www.Ionis.com . Ionis Pharmaceuticals® and TRYNGOLZATM are trademarks of Ionis Pharmaceuticals, Inc. Ionis Investor Contact: D. Wade Walke , Ph.D. info@ionis.com 760-603-2331 Ionis Media Contact: Hayley Soffer media@ionis.com 760-603-4679 View original content: https://www.prnewswire.com/news-releases/tryngolza-olezarsen-approved-in-us-as-first-ever-treatment-for-adults-living-with-familial-chylomicronemia-syndrome-as-an-adjunct-to-diet-302336747.html SOURCE Ionis Pharmaceuticals, Inc.
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OMAHA, Neb. (AP) — Creighton point guard Steven Ashworth likely won't play Tuesday in the No. 21 Bluejays' game against San Diego State in the Players Era Festival in Las Vegas. Ashworth sprained his right ankle late in a loss to Nebraska on Friday, and coach Greg McDermott said he didn't know how long he would be out. Javascript is required for you to be able to read premium content. Please enable it in your browser settings.The first trailer for James Gunn’s Superman is here and, wow. It’s a lot. There’s not much in the way of talking but the two minute-plus trailer is robust in terms of tone, character, and setting. Below, we break down who’s who , what’s what, speculate, and see what little teases Gunn has in store along the way. Here’s our breakdown of the first trailer for Superman . The trailer starts in a snowy field when an object flies in from the sky and crashes into the ground. This is Superman (David Corenswet) and he’s messed up. Breathing heavy, bloodied, this is not what we’re used to seeing from the character. He’s basically indestructible, is he not? How did this happen? Now, if you read our report from the set of the film, Gunn said that Superman starts in the middle of a massive battle. Then, io9 spoke to Gunn at a recent event where he confirmed these scenes are from the very beginning of the movie. That’s quite the twist, is it not? This isn’t him being beaten up in the climax of the film. It’s where everything starts. Busted-up Superman is intercut with scenes of his alter ego, Clark Kent, entering the Daily Planet. Again, from our set report we know this exterior was filmed in Cleveland, Ohio, the birthplace of Superman. But in this film, as you can see from the plaque, it’s Metropolis. Upstairs at the Daily Planet, we meet Lois Lane (Rachel Brosnahan) and also get a glimpse of Jimmy Olsen (Skyler Gisondo). On screen, you see Annalisa Cochrane (Cobra Kai) though it’s unclear if she’s a news anchor or an actress on TV. Either way, it’s a bustling newsroom. After a few close-ups of Lois and Clark, which show more of a friendship than anything else, the trailer moves to the Kent farm, which has cows roaming in the front yard. There we see Clark with his Earth father, Jonathan (Pruitt Taylor Vince). What’s interesting about this shot is that Clark doesn’t have the glasses. He looks more like he does as Superman. Maybe this speaks to the true Clark/Superman that only a few people know, like his parents. All this still is intercutting with Superman bloodied in the snow. Back there he whistles, and a figure runs through the powder. It’s Krypto, Superman’s dog! First introduced in 1955 as a companion of Superboy, and originally conceived as a one-off character by creators Otto Binder and Curt Swan, Krypto’s immediate popularity saw him become a staple of Superman’s adventures ever since, and helped inspire a legion of super-pets in his wake. “Krypto. Home,” Superman says. “Take me home.” So he gives Krypto a sniff of his cape and off the two go. Also, by the way, where did Krypto get his cape? Does his origin fit into this? We don’t know. And, again, all this stuff with Krypto and Superman in the snow is from the BEGINNING of the movie. What could’ve gotten Superman so badly? Here’s where things kick into high gear. First, we see Superman save a girl from some kind of explosion of gas tanks. The explosion comes during a massive kaiju battle. You can see the monster’s foot in the back here, and in full form later. We think, but are just speculating, that this fight might be the one that starts the movie and beats him up so badly. The next several shots focus on Lex Luthor (Nicholas Hoult). First, he sees Superman whiz by and turns around while rocking an earpiece. That cuts to this image of Lex’s building and company in the film, Luthorcorp. You can see him as a tiny speck on the bridge below the first “R.” This next shot is curious. It’s Lex, again, who seems interested and even confused by a seemingly normal-looking revolver. We know from our chat with Gunn that Lex is a master of technology in this movie. So much so he’s basically a “sorcerer.” Why is he so perplexed and fascinated by a gun that would fit in an old Western? Kryptonite bullets possibly? That’s followed by Superman punching out of some kind of glass enclosure. It looks like it’s part of a larger building and, juxtaposed after several shots of Lex and Luthorcorp, the assumption is it’s something inside that building. Plus, at the VERY beginning of the shot, you see there are other people around him. Fellow prisoners? We don’t know. From there, the trailer cuts to a foreign country where war is being waged. A young man heroically lifts a flag with Superman’s symbol on it and prays for Superman to come and save him. Later in the trailer, it’s revealed this is a border war in Boravia, a fictional country in the DC universe. Boravia is also a classic Siegel-Schuster creation, having first appeared in the second issue of Superman in 1939, almost always defined by being in a state of perpetual internal conflict. How it fits into the story we don’t know, but it does speak to Superman being a global hero in this DC Universe. He’s not just saving people in Metropolis. It’s everywhere. Maybe the people of Metropolis are angry at Superman for saving people around the world, though, because the next section of the trailer focuses on angry mobs letting Superman have it. They’re throwing things. Screaming at him. And he’s taking it. Plus, you can see that his suit has been considerably dirtied up. He’s been in quite a battle. People are pissed! And it’s weird that Superman would be able to find refuge in this lobby, is it not? Unless it was somewhere friendly. This is the lobby of Stagg Industries, another reference to DC Comics. In the comics, its owner Simon Stagg is the one behind Rex Mason’s transformation into the character of Metamorpho, who we’ll soon see in the trailer. Whether or not that’s still the case here, is unclear. So we have dejected Superman, standing the lobby of Stagg, who is then joined by several heroes. The first is Guy Gardner (Nathan Fillion). One of several humans to have become a member of the Green Lantern Corps, Guy—and his infamous haircut—first appeared in the late ’60s as the “backup” Lantern of Sector 2814 to Hal Jordan. We know Guy will also make an appearance in the Lanterns TV series , set to feature two of the other most famous human Green Lanterns: Hal Jordan and John Stewart. And, you can see in that shot he’d joined by Hawkgirl, played by Madame Web ‘s own Isabela Merced. You can briefly get a glimpse of Mister Terrific in a quick shot too, but more on him later. The trailer gives Hawkgirl a nice hero shot through. Hawkgirl has had many different iterations in the comics over the years, so we’re not quite sure which version of her we’re getting here. We then see a much better shot of the mystery kaiju Superman was fighting and saving that girl from. Looks pretty scary. After a shot of Superman floating in that fire, things get even steamier. First up, we get this shot of Superman and Lois. And I say “Superman” specifically because you can track how Lois treats Superman one way and Clark the other. There’s something there, but they are just getting close. Nothing more. Also—it’s that weird ball of energy that was in the first promo shot of the film. We still have no idea what that is but we think it might be from near the end of the movie. Okay, so that’s Lois and Superman. Here’s Lois and Clark. And they’re fully making out. So are Clark and Lois dating but she doesn’t know he’s Superman? I mean, come on. You’re a smart woman, Lois! He sure looks like Superman, does he not? Gunn did say their relationship in the film is unlike anything we’ve ever seen in a superhero movie so, surely there’s more to it than that. Moving along, this is a fascinating one. Here we see Superman sad about the death of a robot. It also appears this takes place in the Fortress of Solitude, which hasn’t been featured at all in this trailer so far. (The next shot after this, however, is the Fortress coming out of the ground so—yes, it’s in there.) It’s unclear who the robot is though and some have speculated it’s Kelex, a Kryptonian service robot who once served Jor-El before surviving the destruction of Krypton and becoming the caretake of the Fortress. If it’s not Kelex, the cape and the general Superman-esque color scheme on the robot could be a nod to one of the film’s major comics inspirations, All-Star Superman , which saw a whole host of robotic Supermen assist Clark in maintaining the Fortress of Solitude. That’s then followed by our first look at Metamorpho played by Barry’s Anthony Carrigan. Again, Metamorpho was created by Stagg in the comics, after he sent Rex Mason to go investigate the mysterious radioactive meteorite known as the Orb of Ra, knowing the object could irrevocably transform Rex after he caught him in a relationship with his daughter, Sapphire. Okay, now things really kick into high gear with lots of very quick cuts. First up, buildings toppling over like dominos. Possibly from the kaiju fight? Either way, a very cool image. And maybe I’m seeing things but does the top of that last building look a little green to you? Lex Luthor is PISSED. And injured. And not in his Luthorcorp building, it seems, because it looks more gold than silver. There’s a lot going on in this next image so check it out and then we’ll break it down. First of all, whoever is watching this (unclear) owns a Luthorcorp TV (interesting). Again, we’re seeing more footage from the conflict glimpsed earlier, properly confirmed as Boravia here. Which, from earlier in the trailer, we know is hoping for Superman’s help. In fact, it might even be the same kid. Also, the channel is GBS News. The “G” in there isn’t an “M” so it’s probably not Metropolis. Someone might be watching this from Gotham City. We next see Superman trying to hold up a building, Krypto dragging him in the snow (both from scenes earlier in the trailer), and then someone, we think Metamorpho, smashing a wall. That’s followed by a battle in a baseball stadium (which Major League Baseball confirmed was shot in the Cleveland Guardians stadium). Earlier in the trailer it doesn’t look like Metamorpho is wearing a suit but, clearly, this person is. Is it Metamorpho? He could certainly be a challenge for Superman. Or is it someone else? Someone in a suit Lex has developed perhaps? Either way, the grounds crew for the Metropolis Meteors is gonna have a hell of a cleanup. Finally, we get our best glimpse yet at Mister Terrific, played by For All Mankind ‘s Edi Gathegi. Mister Terrific—this is more clearly the Michael Holt version of the character, introduced back in 1997, frequently a prominent member of the Justice Society of America—is one of Gunn’s favorite characters, which is why he’s in the movie. Gunn also revealed he’s the leader of this group of heroes that’ll be beside Superman in the movie. The shot continues to reveal more about him. Mister Terrific doesn’t have powers beyond his own high technical skill and smarts, which he has used to develop tech to help him be a hero, mainly, his T-Spheres, which you see here. It seems also as if, in context of the movie, Mister Terrific is protecting Lois Lane from gunfire (maybe on assignment in Boravia?) with Jimmy Olsen (kneeling right) in tow. Why are these people shooting at a journalist? Where is Superman? There’s Superman. And he’s kissing Lois in mid-air. Before, we saw her kissing Clark so we’re guessing this is from later in the movie when she realizes the two are one. A gorgeous shot though, in some sort of old building that certainly fits in with the kind of classic architecture we’ve seen in Metropolis elsewhere in the film. And just like that... Superman flies off. But not before the two stars share a warm embrace (with that weird sky thing still looming in the background). Now, throughout this whole trailer, there have also been title cards. Let’s recap those for a second. “From James Gunn, director of the Guardians of the Galaxy trilogy, this summer, it begins.” That’s followed by a ton of footage and then the release date, July 11. Finally, this. That’s where the title of the movie should go, not the studio logo. But we never are explicitly told this is Superman . This is DC Studios. A few things here. First, Superman is the first film in the new DC Universe, and the kick-off of what DC Studios has to offer. So this trailer isn’t just for Superman , it’s for the entire studio and universe. We asked Gunn about the decision. “It just felt good,” he said. “We had made these trailers and they did all this testing and I was like... I believe in testing. I believe in the testing process, and we’ve already tested Superman . But it’s also like, you have to go with your gut and what feels right ... [and it] seems like it worked.” Gunn also told us that the Engineer, another key DC Comics character who is in the movie, IS in this trailer. We didn’t spot her, but maybe you can? And finally, Gunn added that this trailer was specifically crafted to evoke the emotions of the movie. “There was only one thing that was on the forefront of my mind [and] that was the trailer has to be an authentic representation of what the film is,” Gunn said. “It doesn’t have to have every single element that’s in the film, obviously, but it has to show what is the basic essence of the movie and the story we’re telling. And I think that it does that.” If the movie is as good as this trailer, we’re in for a treat. Superman opens July 11.
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