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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 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: 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: 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: 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. 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 (Ticker: DBV, ISIN code: FR0010417345) and the Company's ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309). 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 [email protected] Media Contact Angela Marcucci DBV Technologies [email protected] Attachment PDF VersionMOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Dec 9, 2024-- Intuit Inc. (NASDAQ: INTU) and Amazon (NASDAQ: AMZN) today announced a multi-year strategic partnership to empower millions of Amazon sellers to manage their finances, stay compliant, access capital, and grow their business. By leveraging Intuit’s AI-driven expert platform, millions of Amazon sellers will be able to discover and access Intuit’s platform seamlessly, benefiting from powerful financial insights like profitability, cash flow, and estimated tax liabilities to fuel their growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241209817038/en/ Intuit and Amazon expand strategic partnership (Graphic: Business Wire) QuickBooks will become Amazon’s preferred partner for financial management solutions integrated directly in Amazon Seller Central, the Amazon site where sellers manage their businesses. “Intuit and Amazon are providing financial tools for millions of Amazon sellers to thrive in Amazon’s store,” said Intuit CEO Sasan Goodarzi. “We know businesses that use Intuit’s QuickBooks platform have a nearly 20-point higher success rate than those who don’t. We’re proud to partner with Amazon to bring the benefits of our AI-driven expert platform to help sellers boost their revenue and profitability, save time, and grow with confidence.” “Amazon is innovating on behalf of sellers every day to support the growth and success of their businesses, which includes providing sellers with streamlined access to third-party tools that offer additional efficiencies and capabilities to help them operate their business,” said Dharmesh Mehta, VP WW Selling Partner Services at Amazon. “Together with Intuit, we’re working to equip our selling partners with additional financial tools and access to capital to help them scale efficiently.” This partnership will help Amazon sellers manage and grow their businesses with real-time financial updates, powered by new integrations. Sellers will have the ability to bring their existing Amazon data into Intuit’s AI-powered business platform, ultimately making it easier for sellers to understand and optimize profitability, manage cash flow, access capital, and simplify taxes with confidence. Key benefits for sellers include: A pathway to growth Intuit’s AI-powered business platform helps small and mid-market businesses gain deep insights into where they stand and helps them stay compliant and organized so they can focus on growing their business. This includes access to a robust financial and workforce management platform, with multi-entity financial management, payroll, bill pay and payments, marketing automation, live expert help, third-party integrations, and more. Intuit's objective is to leverage its platform capabilities to grow with Amazon sellers and fuel their success. A strong commitment to responsible AI and data stewardship Intuit’s AI-driven expert platform and products are built in keeping with the company’s commitment to data privacy, security, and responsible AI governance. Intuit safeguards customer data and protects privacy using industry-leading technology and practices and adheres to responsible AI principles. Intuit is a member of the U.S. Artificial Intelligence Safety Institute Consortium, established by the National Institute of Standards and Technology (NIST). Availability Intuit and Amazon will start rolling out these capabilities in mid-2025. The companies will initially focus on delivering capabilities for sellers in the U.S., with international availability to follow. About Intuit Intuit is the global financial technology platform that powers prosperity for the people and communities we serve. With approximately 100 million customers worldwide using products such as TurboTax , Credit Karma , QuickBooks , and Mailchimp , we believe that everyone should have the opportunity to prosper. We never stop working to find new, innovative ways to make that possible. Please visit us at Intuit.com and find us on social for the latest information about Intuit and our products and services. View source version on businesswire.com : https://www.businesswire.com/news/home/20241209817038/en/ CONTACT: Media Contact: Sara Day, Intuit PR 650-336-3123 sara_day@intuit.com KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA CANADA INDUSTRY KEYWORD: SOFTWARE ACCOUNTING ONLINE RETAIL INTERNET PROFESSIONAL SERVICES BUSINESS FINTECH ELECTRONIC COMMERCE TECHNOLOGY ARTIFICIAL INTELLIGENCE RETAIL FINANCE SOURCE: Intuit Inc. Copyright Business Wire 2024. PUB: 12/09/2024 04:00 PM/DISC: 12/09/2024 04:02 PM http://www.businesswire.com/news/home/20241209817038/en
Dow ends at fresh record as oil prices pull back on ceasefire hopesShania Twain celebrates Christmas with cozy, make-up free look Shania Twain showed off cozy, no-makeup look on social media celebrating Christmas Shania Twain wants to feel cozy rather than fancy this Christmas. The singer-songwriter embraced a relaxed and cozy Christmas look this year, proving the comfort of festive sweaters and minimal makeup. On Sunday, December 25, the 59-year-old country music star shared a holiday greeting with her fans on Instagram, showcasing her festive attire. Twain opted for a casual at-home winter outfit, featuring a messy bun hairstyle, leggings, and a grey knitted Christmas sweater adorned with glittery Mickey and Minnie Mouse and the word "Jolly." "Merry Christmas from snowy Switzerland!," Twain captioned the photo. The post included a picture of the You're Still the One singer in the kitchen, seemingly preparing a holiday meal, along with a video of her dog playing in the snow next to a decorated outdoor Christmas tree. Twain's recent public appearance was at the 2024 People's Choice Country Awards in September, where she served as host. For that event, she sported a flippy blonde bob and smoky eye makeup. Speaking to People at that time, she reflected on her 30-plus years in the music industry, noting that the "creative element" of her work continues to drive her. "I love new songwriting. I love design and production. There's so much more that goes into being an artist than just standing on the stage and singing — even though, of course, that's a very bug part," she said. "But I think there's a lot the fans may not be aware of that goes on, and it's fun to share." She also added, “I definitely wear a lot of hats, and that keeps me motivated.” Late Dame Maggie Smith to get tribute in third ‘Downton Abbey’ movie Eva Longoria boasts about her Turkey-stuffed Zucchini boats Mila Kunis recalls growing up as Jewish kid before movie to USA Selena Gomez, Benny Blanco get cosy on first Christmas after engagementVerisk Analytics Inc. stock underperforms Wednesday when compared to competitors
Tua Tagovailoa says he's had personal security since one of his cars was broken into MIAMI GARDENS, Fla. (AP) — Tua Tagovailoa doesn't want to take chances with his family's safety, so the Miami Dolphins’ star quarterback hired personal security when one of his cars was broken into about a year ago. Alanis Thames, The Associated Press Dec 11, 2024 1:26 PM Dec 11, 2024 1:35 PM Share by Email Share on Facebook Share on X Share on LinkedIn Print Share via Text Message Miami Dolphins quarterback Tua Tagovailoa (1) speaks during a news conference following an NFL football game against the New York Jets, Sunday, Dec. 8, 2024, in Miami Gardens, Fla. (AP Photo/Wilfredo Lee) MIAMI GARDENS, Fla. (AP) — Tua Tagovailoa doesn't want to take chances with his family's safety, so the Miami Dolphins’ star quarterback hired personal security when one of his cars was broken into about a year ago. "(It was) a little too close for my comfort with my family being in the house,” Tagovailoa said Wednesday. “So we got personal security to take care of all of that. When we're on the road, we've got someone with my wife, got someone also at the house, surveying the house.” Tagovailoa, speaking days after the home of Cincinnati quarterback Joe Burrow was broken into while the Bengals were playing a Monday night game at Dallas, also noted his security is armed, "so I hope that if you decide to go to my house, you think twice.” Burrow's home was the latest targeted in a string of burglaries of pro athletes' homes in the U.S., which included the homes of Kansas City Chiefs stars Patrick Mahomes and Travis Kelce. Mahomes' and Kelce's homes were broken into in October, prompting the NFL to issue a security alert to teams and the players' union warning that the houses of numerous pro athletes were “increasingly targeted for burglaries by organized and skilled groups," according to a memo previously obtained by The Associated Press. Law enforcement officials noted these groups target the homes on days the athletes have games. Players were told to take precautions and implement home security measures to reduce the risk of being targeted. Tagovailoa's personal security has been in place since long before this string of break-ins. No one was injured in the Monday night break-in at Burrow's home, but it was ransacked, according to a report provided by the Hamilton County Sheriff’s Office. In the NBA , Milwaukee Bucks forward Bobby Portis had his home broken into Nov. 2 and Minnesota Timberwolves guard Mike Conley Jr.’s home was burglarized on Sept. 15 while he was at a Minnesota Vikings game. Portis had offered a $40,000 reward for information, and the NBA later issued its own memo revealing that the FBI has connected some burglaries to “transnational South American Theft Groups” that are “reportedly well-organized, sophisticated rings that incorporate advanced techniques and technologies, including pre-surveillance, drones, and signal jamming devices.” Some of the groups have conducted extensive surveillance on targets, including attempted home deliveries and posing as grounds maintenance or joggers in the neighborhood, according to officials. Tagovailoa, who just signed an extension with the Dolphins last offseason, said he doesn't necessarily feel like a target, "but I wouldn't want to play the chances with my family and kids sleeping, my wife sleeping, me sleeping at the house.” ___ AP NFL: https://apnews.com/hub/nfl Alanis Thames, The Associated Press See a typo/mistake? Have a story/tip? This has been shared 0 times 0 Shares Share by Email Share on Facebook Share on X Share on LinkedIn Print Share via Text Message Get your daily Victoria news briefing Email Sign Up More Football (NFL) Rape allegation against Jay-Z won’t impact NFL's relationship with music mogul, Goodell says Dec 11, 2024 2:17 PM Drew Lock has a heel injury so Tommy DeVito may start at QB for Giants vs. Ravens Dec 11, 2024 2:15 PM Vince Carter and Tracy McGrady join Bills' ownership group as limited partners Dec 11, 2024 2:09 PMAt least 65 million tune in for Netflix NFL Christmas Day games. NBA holiday ratings also skyrocket