首页 > 

treasure of the aztecs

2025-01-24
Report: 2017 DOJ Spied on Kash Patel, Lawmakers, Congressional Staffers, ReportersATLANTA, Dec. 11, 2024 (GLOBE NEWSWIRE) -- Oxford Industries, Inc. (NYSE:OXM) today announced financial results for its third quarter of fiscal 2024 ended November 2, 2024. Consolidated net sales in the third quarter of fiscal 2024 were $308 million compared to $327 million in the third quarter of fiscal 2023. Loss per share on a GAAP basis was $0.25 compared to net earnings per share of $0.68 in the third quarter of fiscal 2023. On an adjusted basis, loss per share was $0.11 compared to net earnings per share of $1.01 in the third quarter of fiscal 2023. Tom Chubb, Chairman and CEO, commented, “Following a difficult third quarter, we are pleased with the beginning of the holiday season now that some recent headwinds have started to abate. The cumulative effects of several years of high inflation combined with distractions from the U.S. elections and other world events, led to less frequent and more tentative consumer spending behavior during the third quarter which is traditionally our smallest volume quarter of the year. Additionally, our most significant and important market, the Southeastern United States, was impacted by two major hurricanes in quick succession that resulted in estimated lost sales of $4 million and an estimated impact of $0.14 per share. When combined with a highly competitive and promotional environment, these headwinds led to financial performance that was weaker than expected.” Mr. Chubb concluded, “Encouragingly, consumers have responded favorably to our recent product introductions and marketing campaigns, driving a nice improvement in comp store trends once the holiday season got underway. However, due to the weaker than expected consumer environment before the election and the fourth quarter impact of the hurricanes, which we project will include an additional $3 million of lost revenue and $0.11 per share, we have lowered our fiscal 2024 sales and EPS guidance. We are confident that our business model will drive profitable growth and long-term shareholder value well into the future. We could not do this without our exceptional team of people, to whom we extend our sincere gratitude.” Third Quarter of Fiscal 2024 versus Fiscal 2023 Consolidated net sales of $308 million decreased compared to sales of $327 million in the third quarter of fiscal 2023. Full-price direct-to-consumer (DTC) sales decreased 8% to $200 million versus the third quarter of fiscal 2023. Full-price retail sales of $99 million were 6% lower than prior-year period. E-commerce sales of $101 million were 11% lower than prior-year period. Outlet sales of $17 million were 3% higher than prior-year period. Food and beverage sales were $24 million, a 4% increase versus prior-year period. Wholesale sales of $67 million were 2% lower than the third quarter of fiscal 2023. Gross margin was 63.1% on a GAAP basis, compared to 62.9% in the third quarter of fiscal 2023. The increase in gross margin was primarily due to a $4 million lower LIFO accounting charge and lower discounts at Lilly Pulitzer. This was partially offset due to full-price retail and e-commerce sales representing a lower proportion of net sales at Tommy Bahama, Lilly Pulitzer and Johnny Was with more sales occurring during promotional and clearance events. Adjusted gross margin, which excludes the effect of LIFO accounting, decreased to 63.0% compared to 64.0% on an adjusted basis in the prior-year period. SG&A was $205 million compared to $195 million last year. On an adjusted basis, SG&A was $201 million compared to $191 million in the prior-year period. The increase in SG&A was primarily driven by: Expenses related to 33 new store openings since the third quarter of fiscal 2023, including four Tommy Bahama Marlin Bars. Pre-opening expenses related to approximately five additional stores planned to open in the fourth quarter of fiscal 2024, including two additional Tommy Bahama Marlin Bars that are expected to open in the next few months. The addition of Jack Rogers. Royalties and other operating income of $4 million were comparable to the third quarter of fiscal 2023. Operating loss was $6 million, or (2.0%) of net sales, compared to operating income of $14 million, or 4.4% of net sales, in the third quarter of fiscal 2023. On an adjusted basis, operating income decreased to an operating loss of $3 million, or (1.1%) of net sales, compared to operating income of $21 million, or 6.6% of net sales, in the third quarter of fiscal 2023. The decreased operating income includes the impact of decreased net sales and increased SG&A as the Company continues to invest in the business. Interest expense decreased from $1 million in the prior year period. The decreased interest expense was primarily due to a lower average outstanding debt balance during the third quarter of fiscal 2024 than the third quarter of fiscal 2023. Due to lower earnings during the third quarter as compared to our other fiscal quarters, certain discrete or other items have a more pronounced impact on the effective tax rate. Our effective income tax rate of 42.5% for the third quarter of fiscal 2024 included the impact of discrete, favorable US federal return-to-provision adjustments primarily related to an increase in the research and development tax credit and certain adjustments to the US taxation on foreign earnings. For the third quarter of fiscal 2023, our effective income tax rate of 18.6% included the favorable utilization of the research and development tax credit and adjustments to the US taxation on foreign earnings which reduced the effective tax rate. Balance Sheet and Liquidity Inventory decreased $3 million, or 2%, on a LIFO basis and increased $2 million, or 1%, on a FIFO basis compared to the end of the third quarter of fiscal 2023. Inventory balances were comparable in all operating groups. During the first nine months of fiscal 2024, cash flow from operations was $104 million compared to $169 million in the first nine months of fiscal 2023. The cash flow from operations in the first nine months of fiscal 2024, along with borrowings of $29 million, provided sufficient cash to fund $92 million of capital expenditures and $33 million of dividends. During the third quarter of fiscal 2024, long-term debt decreased to $58 million compared to $66 million of borrowings outstanding at the end of the third quarter of fiscal 2023 as cash flow from operations exceeded increased capital expenditures primarily associated with the project to build a new distribution center in Lyons, Georgia, payments of dividends and working capital requirements. The Company had $7 million of cash and cash equivalents versus $8 million of cash and cash equivalents at the end of the third quarter of fiscal 2023. Dividend The Board of Directors declared a quarterly cash dividend of $0.67 per share. The dividend is payable on January 31, 2025 to shareholders of record as of the close of business on January 17, 2025. The Company has paid dividends every quarter since it became publicly owned in 1960. Outlook For fiscal 2024 ending on February 1, 2025, the Company revised its sales and EPS guidance. The Company now expects net sales in a range of $1.50 billion to $1.52 billion as compared to net sales of $1.57 billion in fiscal 2023. In fiscal 2024, GAAP EPS is expected to be between $5.78 and $5.98 compared to fiscal 2023 GAAP EPS of $3.82. Adjusted EPS is expected to be between $6.50 and $6.70, compared to fiscal 2023 adjusted EPS of $10.15. For the fourth quarter of fiscal 2024, the Company expects net sales to be between $375 million and $395 million compared to net sales of $404 million in the fourth quarter of fiscal 2023. GAAP EPS is expected to be between $1.02 and $1.22 in the fourth quarter compared to a GAAP loss per share of $3.85 in the fourth quarter of fiscal 2023 that included noncash impairment charges totaling $114 million, or $5.31 per share. Adjusted EPS is expected to be between $1.18 and $1.38 compared to adjusted EPS of $1.90 in the fourth quarter of fiscal 2023. The Company anticipates interest expense of $3 million in fiscal 2024, with interest expense expected to be $1 million in the fourth quarter of fiscal 2024. The Company’s effective tax rate is expected to be approximately 23% for the full year of fiscal 2024. Capital expenditures in fiscal 2024, including the $92 million in the first nine months of fiscal 2024, are expected to be approximately $150 million compared to $74 million in fiscal 2023. The planned year-over-year increase in capital expenditures includes approximately $75 million now budgeted in fiscal 2024 for the distribution center project in Lyons, Georgia. Additionally, we have been investing in new brick and mortar locations, relocations and remodels of existing locations resulting in a year-over-year net increase of full price stores of approximately 30 by the end of fiscal 2024, which includes approximately five planned to open in the fourth quarter of the year. We will also continue with our investments in our various technology systems initiatives, including e-commerce and omnichannel capabilities, data management and analytics, customer data and insights, cybersecurity, automation, including artificial intelligence, and infrastructure. Conference Call The Company will hold a conference call with senior management to discuss its financial results at 4:30 p.m. ET today. A live web cast of the conference call will be available on the Company’s website at www.oxfordinc.com. A replay of the call will be available through December 25, 2024 by dialing (412) 317-6671 access code 13750235. About Oxford Oxford Industries, Inc., a leader in the apparel industry, owns and markets the distinctive Tommy Bahama ® , Lilly Pulitzer ® , Johnny Was®, Southern Tide ® , The Beaufort Bonnet Company ® , Duck Head ® and Jack Rogers ® lifestyle brands. Oxford's stock has traded on the New York Stock Exchange since 1964 under the symbol OXM. For more information, please visit Oxford's website at www.oxfordinc.com. Basis of Presentation All per share information is presented on a diluted basis. Non-GAAP Financial Information The Company reports its consolidated financial statements in accordance with generally accepted accounting principles (GAAP). To supplement these consolidated financial results, management believes that a presentation and discussion of certain financial measures on an adjusted basis, which exclude certain non-operating or discrete gains, charges or other items, may provide a more meaningful basis on which investors may compare the Company’s ongoing results of operations between periods. These measures include adjusted earnings, adjusted earnings per share, adjusted gross profit, adjusted gross margin, adjusted SG&A, and adjusted operating income, among others. Management uses these non-GAAP financial measures in making financial, operational, and planning decisions to evaluate the Company’s ongoing performance. Management also uses these adjusted financial measures to discuss its business with investment and other financial institutions, its board of directors and others. Reconciliations of these adjusted measures to the most directly comparable financial measures calculated in accordance with GAAP are presented in tables included at the end of this release. Safe Harbor This press release includes statements that constitute forward-looking statements within the meaning of the federal securities laws. Generally, the words "believe," "expect," "intend," "estimate," "anticipate," "project," "will" and similar expressions identify forward-looking statements, which generally are not historical in nature. We intend for all forward-looking statements contained herein, in our press releases or on our website, and all subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf, to be covered by the safe harbor provisions for forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (which Sections were adopted as part of the Private Securities Litigation Reform Act of 1995). Such statements are subject to a number of risks, uncertainties and assumptions including, without limitation, demand for our products, which may be impacted by macroeconomic factors that may impact consumer discretionary spending and pricing levels for apparel and related products, many of which may be impacted by inflationary pressures, elevated interest rates, concerns about the stability of the banking industry or general economic uncertainty, and the effectiveness of measures to mitigate the impact of these factors; possible changes in governmental monetary and fiscal policies, including, but not limited to, Federal Reserve policies in connection with continued inflationary pressures and the impact of the recent elections in the United States; competitive conditions and/or evolving consumer shopping patterns, particularly in a highly promotional retail environment; acquisition activities (such as the acquisition of Johnny Was), including our ability to integrate key functions, recognize anticipated synergies and minimize related disruptions or distractions to our business as a result of these activities; supply chain disruptions; changes in trade policies and regulations, including the potential for increases or changes in duties, current and potentially new tariffs or quotas; costs and availability of labor and freight deliveries, including our ability to appropriately staff our retail stores and food & beverage locations; costs of products as well as the raw materials used in those products, as well as our ability to pass along price increases to consumers; energy costs; our ability to respond to rapidly changing consumer expectations; unseasonal or extreme weather conditions or natural disasters, such as the September and October 2024 hurricanes impacting the Southeastern United States; lack of or insufficient insurance coverage; the ability of business partners, including suppliers, vendors, wholesale customers, licensees, logistics providers and landlords, to meet their obligations to us and/or continue our business relationship to the same degree as they have historically; retention of and disciplined execution by key management and other critical personnel; cybersecurity breaches and ransomware attacks, as well as our and our third party vendors’ ability to properly collect, use, manage and secure business, consumer and employee data and maintain continuity of our information technology systems; the effectiveness of our advertising initiatives in defining, launching and communicating brand-relevant customer experiences; the level of our indebtedness, including the risks associated with heightened interest rates on the debt and the potential impact on our ability to operate and expand our business; the timing of shipments requested by our wholesale customers; fluctuations and volatility in global financial and/or real estate markets; our ability to identify and secure suitable locations for new retail store and food & beverage openings; the timing and cost of retail store and food & beverage location openings and remodels, technology implementations and other capital expenditures; the timing, cost and successful implementation of changes to our distribution network; the effectiveness of recent, focused efforts to reassess and realign our operating costs in light of revenue trends, including potential disruptions to our operations as a result of these efforts; pandemics or other public health crises; expected outcomes of pending or potential litigation and regulatory actions; the increased consumer, employee and regulatory focus on sustainability issues and practices, including failures by our suppliers to adhere to our vendor code of conduct; the regulation or prohibition of goods sourced, or containing raw materials or components, from certain regions and our ability to evidence compliance; access to capital and/or credit markets; factors that could affect our consolidated effective tax rate; the risk of impairment to goodwill and other intangible assets such as the recent impairment charges incurred in our Johnny Was segment; and geopolitical risks, including ongoing challenges between the United States and China and those related to the ongoing war in Ukraine, the Israel-Hamas war and the conflict in the Red Sea region. Forward-looking statements reflect our expectations at the time such forward-looking statements are made, based on information available at such time, and are not guarantees of performance. Although we believe that the expectations reflected in such forward-looking statements are reasonable, these expectations could prove inaccurate as such statements involve risks and uncertainties, many of which are beyond our ability to control or predict. Should one or more of these risks or uncertainties, or other risks or uncertainties not currently known to us or that we currently deem to be immaterial, materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, estimated or projected. Important factors relating to these risks and uncertainties include, but are not limited to, those described in Part I. Item 1A. Risk Factors contained in our Fiscal 2023 Form 10-K, and those described from time to time in our future reports filed with the SEC. We caution that one should not place undue reliance on forward-looking statements, which speak only as of the date on which they are made. We disclaim any intention, obligation or duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.treasure of the aztecs

Trump warns of 'hell to pay' if Hamas doesn't release hostagesNEW YORK — Same iconic statue, very different race. With two-way star Travis Hunter of Colorado and Boise State running back Ashton Jeanty leading the field, these certainly aren't your typical Heisman Trophy contenders. Sure, veteran quarterbacks Dillon Gabriel from top-ranked Oregon and Cam Ward of No. 15 Miami are finalists for college football's most prestigious award as well, but the 90th annual ceremony coming up Saturday night at Lincoln Center in New York City offers a fresh flavor this year. To start with, none of the four are from the powerhouse Southeastern Conference, which has produced four of the past five Heisman winners — two each from Alabama and LSU. Jeanty, who played his home games for a Group of Five team on that peculiar blue turf in Idaho more than 2,100 miles from Manhattan, is the first running back even invited to the Heisman party since 2017. After leading the country with 2,497 yards rushing and 29 touchdowns, he joined quarterback Kellen Moore (2010) as the only Boise State players to be named a finalist. "The running back position has been overlooked for a while now," said Jeanty, who plans to enter the 2025 NFL draft. "There's been a lot of great running backs before me that should have been here in New York, so to kind of carry on the legacy of the running back position I think is great. ... I feel as if I'm representing the whole position." With the votes already in, all four finalists spent Friday conducting interviews and sightseeing in the Big Apple. They were given custom, commemorative watches to mark their achievement. "I'm not a watch guy, but I like it," said Hunter, flashing a smile. The players also took photos beneath the massive billboards in Times Square and later posed with the famous Heisman Trophy, handed out since 1935 to the nation's most outstanding performer. Hunter, the heavy favorite, made sure not to touch it yet. A dominant player on both offense and defense who rarely comes off the field, the wide receiver/cornerback is a throwback to generations gone by and the first full-time, true two-way star in decades. On offense, he had 92 catches for 1,152 yards and 14 touchdowns this season to help the 20th-ranked Buffaloes (9-3) earn their first bowl bid in four years. On defense, he made four interceptions, broke up 11 passes and forced a critical fumble that secured an overtime victory against Baylor. Hunter played 688 defensive snaps and 672 more on offense — the only Power Four conference player with 30-plus snaps on both sides of the ball, according to Colorado research. Call him college football's answer to baseball unicorn Shohei Ohtani. "I think I laid the ground for more people to come in and go two ways," Hunter said. "It starts with your mindset. If you believe you can do it, then you'll be able to do it. And also, I do a lot of treatment. I keep up with my body. I get a lot of recovery." Hunter is Colorado's first Heisman finalist in 30 years. The junior from Suwanee, Georgia, followed flashy coach Deion Sanders from Jackson State, an HBCU that plays in the lower level FCS, to the Rocky Mountains and has already racked up a staggering combination of accolades this week, including The Associated Press player of the year. Hunter also won the Walter Camp Award as national player of the year, along with the Chuck Bednarik Award as the top defensive player and the Biletnikoff Award for best wide receiver. "It just goes to show that I did what I had to do," Hunter said. Next, he'd like to polish off his impressive hardware collection by becoming the second Heisman Trophy recipient in Buffaloes history, after late running back Rashaan Salaam in 1994. "I worked so hard for this moment, so securing the Heisman definitely would set my legacy in college football," Hunter said. "Being here now is like a dream come true." Jeanty carried No. 8 Boise State (12-1) to a Mountain West Conference championship that landed the Broncos the third seed in this year's College Football Playoff. They have a first-round bye before facing the SMU-Penn State winner in the Fiesta Bowl quarterfinal on New Year's Eve. The 5-foot-9, 215-pound junior from Jacksonville, Florida, won the Maxwell Award as college football's top player and the Doak Walker Award for best running back. Jeanty has five touchdown runs of at least 70 yards and has rushed for the fourth-most yards in a season in FBS history — topping the total of 115 teams this year. He needs 132 yards to break the FBS record set by Heisman Trophy winner Barry Sanders at Oklahoma State in 1988. In a pass-happy era, however, Jeanty is trying to become the first running back to win the Heisman Trophy since Derrick Henry for Alabama nine years ago. In fact, quarterbacks have snagged the prize all but four times this century. Gabriel, an Oklahoma transfer, led Oregon (13-0) to a Big Ten title in its first season in the league and the No. 1 seed in the College Football Playoff. The steady senior from Hawaii passed for 3,558 yards and 28 touchdowns with six interceptions. His 73.2% completion rate ranks second in the nation, and he's attempting to join quarterback Marcus Mariota (2014) as Ducks players to win the Heisman Trophy. "I think all the memories start to roll back in your mind," Gabriel said. Ward threw for 4,123 yards and led the nation with a school-record 36 touchdown passes for the high-scoring Hurricanes (10-2) after transferring from Washington State. The senior from West Columbia, Texas, won the Davey O'Brien National Quarterback of the Year award and is looking to join QBs Vinny Testaverde (1986) and Gino Torretta (1992) as Miami players to go home with the Heisman. "I just think there's a recklessness that you have to play with at the quarterback position," Ward said. Be the first to know Get local news delivered to your inbox!

NoneNEW YORK — Same iconic statue, very different race. With two-way star Travis Hunter of Colorado and Boise State running back Ashton Jeanty leading the field, these certainly aren't your typical Heisman Trophy contenders. Sure, veteran quarterbacks Dillon Gabriel from top-ranked Oregon and Cam Ward of No. 15 Miami are finalists for college football's most prestigious award as well, but the 90th annual ceremony coming up Saturday night at Lincoln Center in New York City offers a fresh flavor this year. To start with, none of the four are from the powerhouse Southeastern Conference, which has produced four of the past five Heisman winners — two each from Alabama and LSU. Jeanty, who played his home games for a Group of Five team on that peculiar blue turf in Idaho more than 2,100 miles from Manhattan, is the first running back even invited to the Heisman party since 2017. After leading the country with 2,497 yards rushing and 29 touchdowns, he joined quarterback Kellen Moore (2010) as the only Boise State players to be named a finalist. "The running back position has been overlooked for a while now," said Jeanty, who plans to enter the 2025 NFL draft. "There's been a lot of great running backs before me that should have been here in New York, so to kind of carry on the legacy of the running back position I think is great. ... I feel as if I'm representing the whole position." With the votes already in, all four finalists spent Friday conducting interviews and sightseeing in the Big Apple. They were given custom, commemorative watches to mark their achievement. "I'm not a watch guy, but I like it," said Hunter, flashing a smile. The players also took photos beneath the massive billboards in Times Square and later posed with the famous Heisman Trophy, handed out since 1935 to the nation's most outstanding performer. Hunter, the heavy favorite, made sure not to touch it yet. A dominant player on both offense and defense who rarely comes off the field, the wide receiver/cornerback is a throwback to generations gone by and the first full-time, true two-way star in decades. On offense, he had 92 catches for 1,152 yards and 14 touchdowns this season to help the 20th-ranked Buffaloes (9-3) earn their first bowl bid in four years. On defense, he made four interceptions, broke up 11 passes and forced a critical fumble that secured an overtime victory against Baylor. Hunter played 688 defensive snaps and 672 more on offense — the only Power Four conference player with 30-plus snaps on both sides of the ball, according to Colorado research. Call him college football's answer to baseball unicorn Shohei Ohtani. "I think I laid the ground for more people to come in and go two ways," Hunter said. "It starts with your mindset. If you believe you can do it, then you'll be able to do it. And also, I do a lot of treatment. I keep up with my body. I get a lot of recovery." Hunter is Colorado's first Heisman finalist in 30 years. The junior from Suwanee, Georgia, followed flashy coach Deion Sanders from Jackson State, an HBCU that plays in the lower level FCS, to the Rocky Mountains and has already racked up a staggering combination of accolades this week, including The Associated Press player of the year. Hunter also won the Walter Camp Award as national player of the year, along with the Chuck Bednarik Award as the top defensive player and the Biletnikoff Award for best wide receiver. "It just goes to show that I did what I had to do," Hunter said. Next, he'd like to polish off his impressive hardware collection by becoming the second Heisman Trophy recipient in Buffaloes history, after late running back Rashaan Salaam in 1994. "I worked so hard for this moment, so securing the Heisman definitely would set my legacy in college football," Hunter said. "Being here now is like a dream come true." Jeanty carried No. 8 Boise State (12-1) to a Mountain West Conference championship that landed the Broncos the third seed in this year's College Football Playoff. They have a first-round bye before facing the SMU-Penn State winner in the Fiesta Bowl quarterfinal on New Year's Eve. The 5-foot-9, 215-pound junior from Jacksonville, Florida, won the Maxwell Award as college football's top player and the Doak Walker Award for best running back. Jeanty has five touchdown runs of at least 70 yards and has rushed for the fourth-most yards in a season in FBS history — topping the total of 115 teams this year. He needs 132 yards to break the FBS record set by Heisman Trophy winner Barry Sanders at Oklahoma State in 1988. In a pass-happy era, however, Jeanty is trying to become the first running back to win the Heisman Trophy since Derrick Henry for Alabama nine years ago. In fact, quarterbacks have snagged the prize all but four times this century. Gabriel, an Oklahoma transfer, led Oregon (13-0) to a Big Ten title in its first season in the league and the No. 1 seed in the College Football Playoff. The steady senior from Hawaii passed for 3,558 yards and 28 touchdowns with six interceptions. His 73.2% completion rate ranks second in the nation, and he's attempting to join quarterback Marcus Mariota (2014) as Ducks players to win the Heisman Trophy. "I think all the memories start to roll back in your mind," Gabriel said. Ward threw for 4,123 yards and led the nation with a school-record 36 touchdown passes for the high-scoring Hurricanes (10-2) after transferring from Washington State. The senior from West Columbia, Texas, won the Davey O'Brien National Quarterback of the Year award and is looking to join QBs Vinny Testaverde (1986) and Gino Torretta (1992) as Miami players to go home with the Heisman. "I just think there's a recklessness that you have to play with at the quarterback position," Ward said. Get local news delivered to your inbox!TTM Technologies, Inc. Introduces Innovative Radio Frequency Components for Telecom Band n104 to Enhance 5.5G ApplicationsMia Khalifa's nasty comment about the murder of United Healthcare's CEO that isn't funny

BG Titan and PayDay Takaful Forge a Path to Transform Financial Access in Emerging MarketsFBI issues nationwide warning: Serious cyberattack threatens iPhone, Android users

The Secret to a Winning Smile? Award-Winning Dentist Dr. Curry 12-10-2024 10:50 PM CET | Business, Economy, Finances, Banking & Insurance Press release from: Getnews / PR Agency: The SED Society Image: https://www.getnews.info/wp-content/uploads/2024/12/1733849649.jpeg Raising the standard of dental care in Birmingham has been the hallmark of Dr. Stuart Curry's distinguished career. Raising the standard of dental care in Birmingham has been the hallmark of Dr. Stuart Curry's distinguished career. His commitment to excellence and patient-focused approach have not gone unnoticed, earning him a reputation as one of the city's leading dentists. Dr. Curry's recent accolades solidify this standing, recognizing his dedication to providing cutting-edge treatments and fostering a welcoming environment for patients of all ages. His passion for dentistry has transcended the walls of his practice, evident in his commitment to ongoing education and the integration of the latest advancements in dental technology. "My greatest reward is witnessing the positive transformations that occur when someone achieves optimal oral health," says Dr. Stuart Curry. "It can be life-changing, boosting confidence, improving overall well-being, and even enhancing social interactions. These motivate me to provide the highest quality of care to every patient who walks through our doors." Dr. Curry's recognition as the best dentist in Birmingham, AL [ https://www.barchart.com/story/news/29399182/say-cheese-dr-curry-keeps-birmingham-families-smiling-bright ], translates into tangible benefits for his practice and the community he serves. This prestigious title attracts patients seeking the highest quality dental care, drawing individuals and families from across the Birmingham area to Stuart Curry Dentistry. Furthermore, it fosters a sense of trust and confidence among his existing patients, reinforcing their decision to choose him for their oral healthcare needs. This esteemed reputation also allows Dr. Curry to further elevate the standard of dentistry in Birmingham, inspiring other practitioners to strive for excellence and contributing to the overall improvement of oral health in the region. As a leading dentist in the Birmingham area [ https://www.healthgrades.com/dentist/dr-stuart-curry-ytj9y ], Dr. Curry has cultivated a reputation for excellence, attracting patients seeking comprehensive care in a comfortable and supportive setting. Beyond his technical expertise, Dr. Curry is known for his compassionate approach and genuine concern for his patients' well-being. This commitment to patient-centered care extends throughout the entire practice, creating a welcoming environment where individuals feel valued and at ease. Even those residents nearby looking for a professional Vestavia Hills dentist [ https://www.google.com/maps/place/Stuart+Curry+Dentistry+Birmingham/@33.4293403,-86.7307891,15z/data=!4m2!3m1!1s0x0:0x1172d3da42a99abc?sa=X&ved=2ahUKEwjf-_STp7H0AhVnJzQIHfaeCeUQ_BJ6BQjGARAF ] often find themselves drawn to Stuart Curry Dentistry due to the practice's renowned reputation for personalized care and commitment to exceeding expectations. To learn more about Dr. Stuart Curry, his award-winning practice, and the comprehensive dental services offered, visit https://currydentistry.com/ . Schedule an appointment today and experience the difference an award-winning dentist can make in creating healthy, confident smiles for the whole family. Location: https://www.google.com/maps/embed?pb=!1m14!1m8!1m3!1d13319.064646578292!2d-86.7307891!3d33.4293403!3m2!1i1024!2i768!4f13.1!3m3!1m2!1s0x0%3A0x1172d3da42a99abc!2sStuart%20Curry%20Dentistry%20Birmingham!5e0!3m2!1sen!2sus!4v1674762682833!5m2!1sen!2sus " width= Media Contact Company Name: Stuart Curry Dentistry Contact Person: Dr. Stuart Curry Email: Send Email [ http://www.universalpressrelease.com/?pr=the-secret-to-a-winning-smile-awardwinning-dentist-dr-curry ] Phone: 205-972-3831 Address:4851 Cahaba River Rd. Ste 101 City: Birmingham State: AL Country: United States Website: https://currydentistry.com This release was published on openPR.‘France needs compromise’ says MP from Macron’s partyInari Medical Announces Reimbursement Approval for ClotTriever® Thrombectomy System in Japan and New Distribution Partnership with Medikit Co., Ltd.

Châtillon, France, December 11 th , 2024 DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study on-track to initiate in 2Q 2025 Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026 FDA confirmed criteria for post-marketing confirmatory study in toddlers 1 – 3 years-old Company to host investor webcast today at 5:00pm ET DBV Technologies (TRQX: DBVp ), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U.S. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch program in toddlers 1 – 3-years-old. The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. DBV and FDA have agreed on the key design elements for a post-marketing confirmatory study. "DBV is pleased to have received, what we believe to be, a clear and reasonable pathway towards an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. This comes on the heels of our October 22 nd press release announcing details in support of our separate Viaskin Peanut programs in 4 – 7 year-olds and in 1 – 7 year-olds in Europe," said Daniel Tassé, Chief Executive Officer, DBV Technologies. "We believe we have decreased the regulatory pathway risk of our programs. DBV can now fully focus on executing the remaining studies that will support two distinct BLAs across age groups and an MAA in Europe. We are grateful to the Agency for its attentive collaboration as we continue to work towards introducing this novel therapy to caregivers and patients as expeditiously as possible." Accelerated Approval Pathway The FDA recently issued written communication confirming an Accelerated Approval pathway for the Viaskin Peanut patch in toddlers 1 – 3-years-old. As a reminder, current FDA guidance for Accelerated Approval includes three qualifying criteria: That the product candidate treats a serious condition That the product candidate generally provides a meaningful advantage over available therapies That the product candidate demonstrates an effect or an intermediate clinical endpoint that is reasonably likely to predict clinical benefit As DBV previously announced , FDA confirmed via written communication that the Viaskin Peanut patch already met criteria one and two. FDA and DBV have been engaged in ongoing dialogue throughout Q4 of this year regarding the intermediate clinical endpoint necessary to meet the third criterion. In the recent written communication, the FDA confirmed the efficacy data from the Company's Phase 3 EPITOPE study can serve as an intermediate clinical endpoint. The FDA has agreed that the endpoint is reasonably likely to predict clinical benefit and will therefore fulfill the requirement for Accelerated Approval. In preparation for commercialization, DBV made slight modifications to the Viaskin Peanut patch used in EPITOPE to increase the simplicity of application for the caregiver and provide product identification on each patch. No changes, including patch shape or size, were made to the device components that are in contact with the patient's skin. Further, to increase the volume of patch production for future commercialization, changes needed to be made to the manufacturing process and location. Although the intended commercial Viaskin Peanut patch is currently being used (N=304) in the ongoing 3-year Open Label Extension to EPITOPE, the collective changes to the commercial Viaskin Peanut patch were viewed by the FDA as constituting a different product relative to the clinical patch used in the EPITOPE study. The Company intends to use the commercial Viaskin Peanut patch in both the COMFORT Toddlers study and the post-marketing confirmatory study. Post-Marketing Confirmatory Study In the recent written communication, FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1 – 3-years-old. DBV and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted. To date, the commercial patch has been used in 304 subjects with over 234,695 patient-days of therapy in the placebo crossover and the EPITOPE Open Label Extension, with no clinically relevant differences in efficacy or safety vs. the clinical patch used in the EPITOPE Phase 3 trial. The confirmatory study will include a double-blind, placebo-controlled food challenge (DBPCFC) and will use the same statistical criteria for success (i.e., lower bound of the 95% CI > 15%) as used in the EPITOPE Phase 3 efficacy study. Adhesion data for the post-marketing confirmatory study will be collected in a similar manner relative to the COMFORT Toddlers study. The Company expects these data will further support the importance of average daily wear time in the use of the Viaskin Peanut patch as it relates to efficacy and labeling. "When it comes to food allergy management, what works for one family, might not work for another. That is why having varied treatment options available is so incredibly important to our community," said Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research & Education). "I'm pleased to learn that DBV's constructive dialogue with the FDA has resulted in this Accelerated Approval guidance outlining remaining developmental steps for the Viaskin Peanut patch in toddlers with a peanut allergy. At FARE, we look forward to the possibility that one day, if approved, caregivers and families will have this exciting new treatment as an option to consider." COMFORT Toddlers Supplemental Safety Study COMFORT Toddlers is a Phase 3 double-blind, placebo-controlled (DBPC) study designed to generate additional safety (primary endpoint) and adhesion data of the Viaskin Peanut patch in peanut allergic toddlers 1 – 3-years old. DBV is pleased to announce that Dr. Julie Wang, MD, Professor of Pediatrics, Jaffe Food Allergy Institute, the Icahn school of Medicine at Mount Sinai, will act as the Global Principal Investigator for the COMFORT Toddlers study. "I am thrilled to assume the role of Global Principal Investigator of the COMFORT Toddlers study," stated Dr. Julie Wang, Professor of Pediatrics, Jaffe Food Allergy Institute, Icahn school of Medicine at Mount Sinai in New York. "Viaskin Peanut, if approved, would offer a much-needed alternative treatment option for patients and caregivers. I look forward to working with the DBV team to advance this important clinical trial." The Company anticipates that COMFORT Toddlers will enroll approximately 480 subjects randomized 3:1 (active: placebo) at approximately 80 – 90 study centers across the U.S., Canada, Australia, and Europe. COMFORT Toddlers will be a six-month study followed by an optional 18-month open-label treatment phase, to provide 24 or 18 months of treatment with the Viaskin Peanut patch for participants randomized to the active or placebo groups, respectively. Thus, the COMFORT Toddlers study will increase the total subjects exposed to the Viaskin Peanut patch for at least six-months in a controlled study to 600, as required by FDA. In total, there will be approximately 240 subjects with the clinical patch in EPITOPE and 360 with the commercial patch in COMFORT Toddlers. As previously disclosed , DBV and FDA have aligned on a patch wear time collection methodology, analysis and study objective hierarchy in the COMFORT Toddlers study. The agreed-upon adhesion data collection methodology provides a practical approach for subjects, families, and investigators. The methodology is intended to generate sufficient data to support a BLA submission under the Accelerated Approval pathway (i.e., collecting patch adhesion data with a focus on daily wear time at relevant time points). We believe there are three positive outcomes coming out of the productive discussions with FDA: FDA agreed that adhesion would not be a co-objective of a safety study and would be an exploratory endpoint. Next, adhesion should be assessed in the overall totality of benefit to risk (i.e., in the context of efficacy and safety). The third success is that we have aligned on what DBV believes is a very feasible approach to collecting adhesion data. DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. Biologic License Application Submission in 1 – 3 Year-Olds There will be two Phase 3 studies in 1 – 3-year-olds using the Viaskin Peanut patch. The data generated from the studies will be used to inform a BLA submission: Twelve months of DBPC efficacy and safety data from the previously completed Phase 3 EPITOPE study (published in the New England Journal of Medicine i n May 2023), and 36 months of open-label extension data. Six months of DBPC data generated in COMFORT Toddlers supplemental safety study. DBV anticipates that the BLA for the Viaskin Peanut patch in toddlers 1 – 3 years-old under the Accelerated Approval program will be submitted in 2H 2026. Investor Conference Call and Webcast DBV management will host an investor conference call and webcast today, Wednesday, December 11 th , at 5:00pm EST, to discuss these regulatory updates. This call is accessible via the below teleconferencing numbers and requesting the DBV Technologies call. United States: +1-877-346-6112 International: +1-848-280-6350 A live webcast of the call will be available on the Investors & Media section of the Company's website: https://www.dbv-technologies.com/investor-relations/ . A replay of the presentation will also be available on DBV's website after the event. About DBV Technologies DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary Viaskin® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPITTM), the Viaskin® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual's underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin's immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company's food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company's ordinary shares are traded on segment B of Euronext Paris DBV FR and the Company's ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market DBVT . For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn . Forward Looking Statements This press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of Viaskin® Peanut patch and EPITTM, designs of DBV's anticipated clinical trials, DBV's planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, plans and expectations regarding initiation of the confirmatory study, plans and expectations with respect to COMFORT Toddlers and COMFORT Children, plans and expectations with respect to the submission of BLAs to FDA, anticipated support for the BLA submission, DBV's expectations with respect to the Accelerated Approval pathway and any other actionable regulatory pathway, and the ability of any of DBV's product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV's product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV's ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV's regulatory filings with the French Autorité des Marchés Financiers ("AMF"), DBV's filings and reports with the U.S. Securities and Exchange Commission ("SEC"), including in DBV's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. Viaskin is a registered trademark and EPIT is a trademark of DBV Technologies. Investor Contact Katie Matthews DBV Technologies katie.matthews@dbv-technologies.com Media Contact Angela Marcucci DBV Technologies angela.marcucci@dbv-technologies.com Attachment PDF Version © 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.I’m A Celeb fans left sobbing as Danny Jones says Barry McGuigan has replaced his dad who no longer speaks to himBut he was named Monday to the Virginia Sports Hall of Fame. "How about that, huh?" Cook said with a chuckle Monday in a phone interview. Cook, a Roanoke County resident who once served as the groundskeeper for the Salem Pirates and Salem Buccaneers, has been the field and stadium consultant for Major League Baseball since 1991. The class of 2025 for the commonwealth's sports hall of fame was announced Monday. Other names of note in the nine-person class include 1975 Martinsville High School graduate and former Detroit Tigers second baseman Lou Whitaker; college basketball television analyst and ex-University of Virginia basketball player Dan Bonner; former soccer star Ali Krieger; ex-NBA player Joe Smith; and former Ferrum football standout Ed George. The class will be inducted in April in Virginia Beach. "Pretty humbling," said Cook, who learned of his selection last month. "Wasn't expecting that one at all. To be part of that group — some pretty high rollers there. Really. really honored to be a part of it." Cook, 64, is president of the Brightview Sports Turf Division, which manages the operations for Major League Baseball's special games in the U.S. and overseas. When Major League Baseball needs to build a field for a special MLB game or tailor an existing stadium for a special game, it turns to Cook. "I enjoy sharing what I've learned over the years," Cook said. "I've been fortunate to have the same crew with me for 25 years or so, so we know what MLB needs ... and we're able to produce some pretty unique things." One of Cook's newest projects will be turning Bristol Motor Speedway into the site of an Aug. 2 game between the Cincinnati Reds and Atlanta Braves. "Doing what we're building down in the Bristol speedway ... is going to be quite unique," Cook said. "How that's going to come together in the time we have to do it, in 30 days, is going to be fun. "The entire field's being built in the middle of pit row. To level it, we're having to bring in almost 17,000 tons of stone and gravel just to be able to build a field on top of it. ... Along with that, there's everything else (to do) — fencing, backstop, ... the bullpens, locker rooms." One of his other new projects will be getting the Tokyo Dome ready for two games between the Los Angeles Dodgers and Chicago Cubs in March. "Whenever you do things in another country, ... they have nice parks and we've got to come in and work with them and make some changes here and there to get it to an MLB level," Cook said. Earlier this year, Cook turned the Sky Dome in South Korea into the site of games between the Dodgers and San Diego Padres. He turned a Mexico City ballpark into the site of games between Houston and Colorado. He had just 18 days to turn London Stadium into the site of games between the New York Mets and Philadelphia. Also this year, Cook helped turn 114-year-old Rickwood Field, a former Negro League ballpark in Birmingham, Alabama, into the site of a game between the St. Louis Cardinals and San Francisco Giants. "We spent a lot of time trying to keep the historical features," Cook said. "A special event." Cook helped build a ballpark next to the setting of the "Field of Dreams" movie in Iowa for a 2021 game between the New York Yankees and Chicago White Sox. "There was nothing out there but corn," Cook. In 2016, Cook helped build a ballpark on an old golf course at Fort Bragg for a game between the Braves and Marlins. In 2017, he turned a minor-league ballpark in Williamsport, Pennsylvania, into an MLB-certified ballpark for a game between Pittsburgh and the Chicago Cubs. The MLB Little League Classic has become an annual event. He also helped construct baseball fields for three Summer Olympics. George will be going into the hall of fame as the recipient of the hall's Distinguished Virginian award. "I was surprised by it," George, 78, said in a phone interview. "If you've been a poor boy all your life and you come from a bad childhood experience, ... you value this stuff. ... So I'm very pleased with it." The E.C. Glass High School graduate was an offensive lineman and tight end for Ferrum Junior College in 1967 and 1968. He then played for Wake Forest and in the Canadian Football League and the NFL. He helped Montreal win two Grey Cups in the CFL and was chosen for the Canadian Football Hall of Fame. "Ferrum gave me a chance," George said. "I came from a very bad child life. I had the bad stepfather, ... got beat up a lot. Ferrum gave me a chance to go to college. "Coach Norton ... taught people what discipline was about — how to train, how to stay focused." George, a Charlottesville resident, used to work for an investment firm. "I consider myself as successful in business as I was in sports," George said. Whitaker played 19 seasons with the Tigers. He had 2,369 hits, 244 homers, 1,084 RBIs and 1,386 runs scored. The former American League rookie of the year and five-time All-Star helped Detroit win the 1984 World Series. Bonner is an analyst for ACC Network men's basketball telecasts and does NCAA Tournament games for CBS and Turner Sports. The Staunton resident used to be a commentator on ACC games for Raycom and for the ACC’s regional cable package. Smith shined at Maury High School and at Maryland before playing 16 seasons in the NBA. Krieger, a Forest Park High School graduate, helped the U.S. women's soccer team win two World Cups. The class also includes ex-Hampton High School football coach Mike Smith; Virginia Beach native and former Virginia Wesleyan basketball star Brandon Adair; and former Richmond News Leader and Virginian-Pilot sports writer Harry Minium.

The Minister of Works, Engr. Nweze David Umahi, has assured that in no distant time the transportation landscape of Nigeria will add value to the security architecture being put in place by the Renewed Hope administration of President Bola Ahmed Tinubu. He made this assurance when he paid a courtesy visit to the new Chief of Army Staff (COAS), Lieutenant General Olufemi Olatubosun Oluyede in his office on Wednesday. The Minister used the opportunity of the courtesy visit to discuss areas of assistance and collaboration in the road infrastructure development roadmap of the federal government, including ongoing projects in strategic economic corridors of the 6 Geo-Political Zones. In his response, Chief of Army Staff (COAS), Lieutenant General Olufemi Olatubosun Oluyede, assured of the continued support of the Nigerian Army to the efforts of the Federal Ministry of Works in tackling the challenges facing the works sector.

Previous: treasures of aztec
Next: treasures of aztec demo