Lindblad Expeditions To Resume Voyages This Summer

PR Newswire

NEW YORK, March 30, 2021 /PRNewswire/ — Lindblad Expeditions, the global provider of small ship expeditions cruises and adventure travel experiences, has announced that they plan to resume operations for the 2021 season in Alaska and Galápagos in June.  In keeping with Lindblad’s focus on exploring remote places, they will return to nature in the pristine wildness of these two iconic destinations.   

In making the announcement, Sven Lindblad, CEO of Lindblad Expeditions, reflected on the experiences of the past year, its impact on many, and how “we have always turned to nature, in times of collective stress and trauma, for the restoration of our spirits, believing in what Thoreau called the healing “tonic of wildness.”

“Our internal team has spent the last year examining every single aspect of our operation to be prepared to operate in the ‘new normal.’ Led by our resident medical expert, Dr. David Lorber, we have enlisted the assistance of many health and safety experts and met with authorities in the regions we intend to explore to ensure we are welcome and meet or exceed their expectations. We will also require that all guests 16 years of age and over be vaccinated prior to travelling onboard,” he stated.

A complete list of health and safety protocols are listed here.  Key components include: two negative COVID-19 tests, daily guest temperature checks, and thorough sanitation protocols.  From start to finish, guests will travel exclusively with their expedition community, all equally tested.

In resuming travel to Alaska, Lindblad intends to head deep into the wide-open spaces, into the far reaches of her straits and waterways—to where bears, glaciers, eagles and whales will be guests’ only ‘companions.’ They will begin the season with 6 and 8-day itineraries aboard their 100-guest sister ships National Geographic Quest and National Geographic Venture, with the first departures June 5th and June 6th.

Similarly, guests will explore the remoteness of the Galápagos archipelago to visit volcanic isles inhabited by some of the most charismatic wildlife on earth on a 10-day itinerary set aboard the 96-guest National Geographic Endeavour llThe first Galápagos departure is set for June 4th.

Guests will return to an exhilarating expedition experience they have come to know and love. They will search for wildlife, revel in the wonders of the natural world, and explore the legendary Alaska and Galápagos archipelago landscapes under the guidance of our amazing expedition team.

For reservations or additional information on Lindblad Expeditions voyages to some of the most beautiful and fascinating places on Earth, visit www.expeditions.com, call 1-800-EXPEDITION (1-800-397-3348) or contact your travel advisor. Find us on Facebook, Twitter,Instagram, YouTube and Pinterest.

For images: From here you can view the images and download high resolution jpgs. Downloaded photos can only to be used in conjunction with promoting Lindblad Expeditions and must include photographer copyright information. 

 

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SOURCE Lindblad Expeditions Holdings, Inc.

Schrödinger to Host Webcast in Conjunction with Presentation of Preclinical Data for Its CDC7 Program at Virtual AACR Annual Meeting

Schrödinger to Host Webcast in Conjunction with Presentation of Preclinical Data for Its CDC7 Program at Virtual AACR Annual Meeting

NEW YORK–(BUSINESS WIRE)–
Schrödinger (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, today announced that it will host a webcast to review the preclinical data being presented from its CDC7 program during a virtual poster session at the upcoming American Association for Cancer Research (AACR) Annual Meeting. The company will also provide an overview of two other internal programs, MALT1 and Wee1, as well as highlight the role of its computational platform in accelerating the discovery of its novel molecules. The webcast will take place Monday, April 12, 2021, at 10:00 a.m. ET.

The webcast will be available under “News & Events” in the investors section of Schrödinger’s website, https://ir.schrodinger.com/news-and-events/event-calendar and will be archived for approximately 7 days.

About Schrödinger

Schrödinger is transforming the way therapeutics and materials are discovered. Schrödinger has pioneered a physics-based software platform that enables discovery of high-quality, novel molecules for drug development and materials applications more rapidly and at lower cost compared to traditional methods. The software platform is used by biopharmaceutical and industrial companies, academic institutions, and government laboratories around the world. Schrödinger’s multidisciplinary drug discovery team also leverages its software platform to advance collaborative programs and its own pipeline of novel therapeutics to address unmet medical needs.

Founded in 1990, Schrödinger has over 450 employees and is engaged with customers and collaborators in more than 70 countries. To learn more, visit www.schrodinger.com and follow us on LinkedIn and Twitter.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 including, but not limited to those regarding our expectations about the speed and capacity of our computational platform, as well as the ability of our platform to accelerate discovery of novel molecules for our internal programs. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Actual results may differ materially from those described in these forward-looking statements and are subject to a variety of assumptions, uncertainties, risks and factors that are beyond our control, including the uncertainties inherent in drug development and commercialization, uncertainties associated with the regulatory review of clinical trials and applications for marketing approvals, and other risks detailed under the caption “Risk Factors” and elsewhere in our Securities and Exchange Commission filings and reports, including our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 4, 2021, as well as future filings and reports by us. Any forward-looking statements contained in this press release speak only as of the date hereof. Except as required by law, we undertake no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events, changes in expectations or otherwise.

Jaren Irene Madden

Schrödinger, Inc.

[email protected]

617-286-6264

Stephanie Simon (media)

Ten Bridge Communications

617-581-9333

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Technology Research Other Technology Software Biotechnology Health Pharmaceutical Science Oncology

MEDIA:

Logiq Acquires Rebel AI to Bring E-commerce Growth to Brands and Agencies

NEW YORK and BOULDER, Colo., March 30, 2021 (GLOBE NEWSWIRE) — Logiq, Inc. (OTCQX: LGIQ), a global provider of award-winning e-commerce and fintech solutions, has acquired Rebel AI, an innovator in digital marketing solutions.

The Rebel AI platform, which is to be named Logiq Digital Marketing, will enable small and medium-sized businesses (SMB) to more effectively compete against larger businesses for new customers. Through a simplified, easy-to-use platform, marketers will be able to advertise across popular websites and connected TV media destinations to attract more consumers to their online stores. Coupled with advanced audience targeting, artificial intelligence algorithms and blockchain-based security, this platform will also lower the costs of customer acquisition.

“Rebel AI’s approach to addressing the needs of e-commerce brands and agencies fully aligns with our strategic focus, and we expect the addition of their proprietary technology to dramatically accelerate the time-to-market of the launch of our holistic digital marketing strategy,” stated Logiq CEO, Tom Furukawa. “Combining our respective strengths and capabilities puts us years ahead in terms of delivering a uniquely powerful platform geared for our SMB agency and brand clients.”

Logiq Digital Marketing is an open AI platform that not only provides flexibility for future development and integrations, but also allows clients to embed their own unique customizations for their business while remaining forward compatible with future enhancements.

“Logiq shares our vision of simplifying the marketing workflow for small and medium businesses,” said Rebel AI’s founder and CEO, Manny Puentes. “By combining Rebel AI’s data management and media buying capabilities, Fixel’s engagement-based AI-segmented audiences, and DataLogiq’s comprehensive consumer profiles into a single platform, we’re laying the foundation for marketers to reach their consumers in an easier and more cost-effective way.”

In the U.S. alone, the top 10 e-commerce players will account for 63.2% of online sales. Along with rising digital media costs, hidden marketing technology fees, and fast-evolving laws and regulations surrounding consumer data and privacy, SMBs have been underserved by the fragmented marketing technologies available to them to date. Logiq Digital Marketing was built specifically to address these challenges.

Further details of the transaction can be found in the company’s current report on Form 8-K filed with the Securities and Exchange Commission and available at sec.gov and from the investor section of the company’s website at ir.logiq.com.

About Logiq


Logiq, Inc.
(OTCQX: LGIQ) is a U.S.-based leading global provider of eCommerce, mCommerce, and fintech business enablement solutions. Its DataLogiq subsidiary provides a data-driven, end-to-end eCommerce marketing solution for enterprises and major U.S. brands, including Home Advisor, QuinStreet and Sunrun. Its AI-powered LogiqX™ data engine delivers valuable consumer insights that enhance the ROI of online marketing spend. The company’s Fixel™ technology offers simplified online marketing with critical privacy features. Logiq Digital Marketing is an end-to-end digital marketing platform for brands and agencies.

Logiq’s AppLogiq™ platform-as-a-service enables small- and medium-sized businesses worldwide to easily create and deploy a native mobile app for their business without technical knowledge or background. AppLogiq empowers businesses to reach more customers, increase sales, manage logistics, and promote their products and services in an easy, affordable, and highly efficient way. AppLogiq is offered in 14 languages across 10 countries and three continents, including some of the fastest-growing emerging markets in Southeast Asia. The company’s PayLogiq™ offers mobile payments, and GoLogiq™ offers hyper-local food delivery services.

For more information about Logiq, go to Logiq.com.

Forward-Looking Disclaimer

This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. Logiq cautions you that statements in this press release that are not a description of historical facts are forward-looking statements. These statements are based on Logiq’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Logiq or its affiliates that any of its plans or expectations will be achieved. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in Logiq’s business, including, without limitation: the ability of Logiq to successfully complete the NEO listing process, the fitness of Logiq’s products and services for a particular application or market, the ability to effectively integrate Rebel AI into our business operations, expectations of future events, business trends, financial results, and/or business transactions that may not be consummated or realized, as well as other risks described in Logiq’s prior press releases and in its filings with the Securities and Exchange Commission (“SEC”), including under the heading “Risk Factors” in Logiq’s Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Logiq undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

Company Contact

Brent Suen, President
Logiq, Inc.
Email contact

Media & Investor Contact

Ronald Both or Grant Stude
CMA Investor & Media Relations
Tel (949) 432-7566
Email contact 



The Law Offices of Frank R. Cruz Announces the Filing of a Securities Class Action on Behalf of Clover Health Investments, Corp. (CLOV, CLOVW) f/k/a Social Capital Hedosophia Holdings Corp. III (IPOC) Investors

PR Newswire

LOS ANGELES, March 30, 2021 /PRNewswire/ — The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of persons and entities that purchased or otherwise acquired Clover Health Investments, Corp. (NASDAQ: CLOV, CLOVW) (“Clover Health” or the “Company”) f/k/a Social Capital Hedosophia Holdings Corp. III (NYSE: IPOC) (“Social Capital III”) securities: (1) between October 6, 2020 and February 4, 2021, inclusive (the “Class Period”); and/or (2) pursuant or traceable to the registration statement and prospectus issued in connection with the December 2020 Merger of Clover and Social Capital III (the “Registration Statement”). Clover investors have until April 6, 2021 to file a lead plaintiff motion.

If you are a shareholder who suffered a loss, click here to participate.

On February 4, 2021, Hindenburg Research released a report entitled “Clover Health: How the ‘King of SPACs’ Lured Retail Investors Into a Broken Business Facing an Active, Undisclosed DOJ Investigation[.]” The report alleged, among other things, that “Clover has not disclosed that its business model and its software offering, called the Clover Assistant, are under active investigation by the Department of Justice (DOJ), which is investigating at least 12 issues ranging from kickbacks to marketing practices to undisclosed third-party deals.”

On this news, the Company’s stock price fell $1.72 per share, or 12.3%, to close at $12.23 per share on February 4, 2021, thereby injuring investors.

On February 5, 2021, Clover issued a response in which it admitted, among other things, that it was aware of the DOJ investigation. The Company also disclosed that it had received a letter from the U.S. Securities and Exchange Commission (“SEC”), indicating that it is conducting an investigation and requesting document and data preservation from January 1, 2020 to the present.

The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) the Company’s Clover Assistant platform was under active investigation by the DOJ for at least 12 issues ranging from kickbacks to marketing practices to undisclosed third-party deals; (2) the DOJ’s investigation presented an existential risk to the Company, since it derives most of its revenues from Medicare; (3) Clover’s sales were driven by a major undisclosed related party deal and misleading marketing targeting the elderly, not its purported “best-in-class” technology; (4) a significant portion of Clover’s sales were by way of an undisclosed relationship between Clover and an outside brokerage firm controlled by Clover’s Head of Sales; and (5) as a result, Defendants’ statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.

Follow us for updates on Twitter: twitter.com/FRC_LAW.

If you purchased Clover Health securities during the Class Period, you may move the Court no later than April 6, 2021to ask the Court to appoint you as lead plaintiff.  To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class.  If you purchased Clover Health securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to [email protected], or visit our website at www.frankcruzlaw.com.  If you inquire by email please include your mailing address, telephone number, and number of shares purchased.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Contacts

The Law Offices of Frank R. Cruz, Los Angeles
Frank R. Cruz, 310-914-5007
[email protected]
www.frankcruzlaw.com

 

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SOURCE The Law Offices of Frank R. Cruz, Los Angeles

Jack Henry Using Experience to Help Shape Future of Instant Payments with the Federal Reserve

Pilot with the Federal Reserve’s instant payments network will add faster payments options for regional and community banks and credit unions

PR Newswire

MONETT, Mo., March 30, 2021 /PRNewswire/ — Jack Henry & Associates, Inc. (NASDAQ: JKHY), a leading provider of technology solutions and payment processing services primarily for the financial services industry, confirmed it will participate in the FedNowSM pilot program. Participating in the program provides the banks and credit unions that leverage JHA PayCenter™ to seamlessly connect to instant payment networks, more choices and interoperability for their faster payment offerings.

Jack Henry partnered with the Federal Reserve in early 2020 and will help shape the features and functions of the FedNow Service, provide input into the overall user experience, help ensure readiness for testing, and be among the first to process instant payments using the service before its general availability. In the initial advisory phase, participant input will help to further define the service and adoption roadmap, prepare for industry readiness, and finalize the Federal Reserve’s overall instant payments strategy. The FedNow Service is expected to provide clearing and settlement functions by 2023.

Banks and credit unions currently have two ways to connect to faster payments networks – independently or through a partner like Jack Henry. Independent implementation requires significant capital and human resources to develop and maintain the connections between existing core and digital solutions and the new payment networks. Many financial institutions do not have the resident resources, expertise, or budget to effectively and efficiently support these complex development requirements. Partnering with Jack Henry eliminates the need for internal development, provides ongoing access to industry and technical experts, reduces the implementation period to 60 to 90 days, and significantly reduces near- and long-term costs.  

Tede Forman, head of Consumer and Commercial Payments for Jack Henry, said, “JHA PayCenter is built on the vision to provide diverse financial institutions and their accountholders with seamless access to the industry’s instant payment solutions. The FedNow Service will be another critical part of that vision and will leverage our ready-built infrastructure to provide banks and credit unions with frictionless access to faster payments networks. We look forward to the opportunity to help develop the functionality and practical use cases and to make material contributions to a service that will advance the evolving payments ecosystem.”

For more information on the FedNow Pilot Program and the FedNow Service, visit FedNow.org.

About the FedNow Service
The Federal Reserve Banks are developing the FedNow Service to facilitate nationwide reach of instant payment services by financial institutions – regardless of size or geographic location – in near real time, around the clock, every day of the year. Through financial institutions participating in the FedNow Service, businesses and individuals will be able to send and receive instant payments around the clock conveniently, and recipients will have full access to funds within seconds, giving them greater flexibility to manage their money and make time-sensitive payments. Access will be provided through the Federal Reserve’s FedLine® network, which serves more than 10,000 financial institutions directly or through their agents. For more information, visit FedNow.org.

About Jack Henry & Associates, Inc.

Jack Henry (NASDAQ: JKHY) is a leading SaaS provider primarily for the financial services industry. We are a S&P 500 company that serves approximately 8,500 clients nationwide through three divisions: Jack Henry Banking® provides innovative solutions to community and regional banks;  Symitar® provides industry-leading solutions to credit unions of all sizes; and ProfitStars® offers highly specialized solutions to financial institutions of every asset size, as well as diverse corporate entities outside of the financial services industry. With a heritage that has been dedicated to openness, partnership, and user centricity for more than 40 years, we are well-positioned as a driving market force in cloud-based digital solutions and payment processing services. We empower our clients and consumers with the human-centered, tech-forward, and insights-driven solutions that will get them where they want to go. Are you future ready? Additional information is available at www.jackhenry.com.

Statements made in this news release that are not historical facts are forward-looking information.  Actual results may differ materially from those projected in any forward-looking information.  Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated by any forward-looking information.  Additional information on these and other factors, which could affect the Company’s financial results, are included in its Securities and Exchange Commission (SEC) filings on Form 10-K, and potential investors should review these statements.  Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual results to differ materially from any forward-looking information.

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SOURCE Jack Henry & Associates, Inc.

DuPont Launches New Biofouling Preventing Technology for Reverse Osmosis Installations

The new DuPont™ B-Free™ pre-treatment technology reduces operational costs and boosts plant uptime and reliability.

PR Newswire

WILMINGTON, Del., March 30, 2021 /PRNewswire-PRWeb/ — DuPont (NYSE:DD), a global science and innovation leader, today announced the launch of a new pre-treatment technology that eliminates the effects of biofouling in Reverse Osmosis (RO) systems to reduce operational costs and to boost plant uptime and reliability.

Biofouling is one of the most common and severe problems in the operation of a reverse osmosis (RO) system. Unchecked, it causes significant operational problems such as frequent interruption, damage to the membranes, intense chemical and energy use, and regular cleaning-in-place (CIP) of the RO.

DuPont Water Solutions is launching a novel pre-treatment technology that efficiently eliminates the effects of biofouling in RO systems.

DuPont™ B-Free™ patent-pending solution is the result of a multi-year research and development effort that consists of a vessel-based media technology that offers a reliable, easy-to-use and sustainable solution. It is based on B-Free™ pre-treatment technology ability to create an instant and sustained biostatic environment for the downstream RO operations without the need for chemicals and resilient to upstream upsets.

DuPont™ B-Free™ pre-treatment is the solution designed for customers suffering from biofouling and looking for designing, building and operating reliable RO systems at an optimized cost of water and sustainability footprint. DuPont™ B-Free™ technology enables an important reduction of Clean-In-Place (CIP) frequency by up to 75% and may double the RO membranes and cartridge filters lifetime. The B-Free customers will be able to achieve a low-touch and stable plant operation with up to 50% lower operations downtime required.

“B-Free™ pre-treatment is a unique breakthrough technology that effectively eliminates biofouling and enables a significant improvement in plant reliability. As a result, this new technology will provide reverse osmosis plant operators the ability to eliminate this troublesome and costly occurrence in RO systems,” said Nanette Hermsen, Global Marketing & Strategy Director DuPont Water Solutions.

With proven robustness and value, DuPont™ B-Free™ pre-treatment technology is now available globally. It is one of several recent innovations DuPont has introduced to help decrease the economic and environmental cost of water treatment to help combat water scarcity, and it is aligned with the United Nations’ Sustainable Development Goals for 2030.

“With this new patent pending technology, DuPont continues demonstrating innovation leadership and commitment to solve customer water challenges,” said Gary Gu, Global Innovation & Technology Leader DuPont Water Solutions.

About DuPont

DuPont (NYSE: DD) is a global innovation leader with technology-based materials and solutions that help transform industries and everyday life. Our employees apply diverse science and expertise to help customers advance their best ideas and deliver essential innovations in key markets including electronics, transportation, construction, water, healthcare and worker safety. More information about the company, its businesses and solutions can be found at http://www.dupont.com. Investors can access information included on the Investor Relations section of the website at investors.dupont.com.

DuPont™, the DuPont Oval Logo, and all trademarks and service marks denoted with ™, SM or ® are owned by affiliates of DuPont de Nemours, Inc. unless otherwise noted.

March 30th, 2021

For further information contact:
Milena Yordanova
+ 34 616 353 793
[email protected]

Media Contact

Milena Yordanova, DuPont, + 34 616 353 793, [email protected]

 

 

SOURCE DuPont

International Paper Acquires Two Corrugated Packaging Plants in Spain

PR Newswire

MEMPHIS, Tenn., March 30, 2021 /PRNewswire/ — International Paper (NYSE: IP) has purchased two state-of-the-art corrugated box plants in Spain, further growing its capabilities in Madrid and Catalonia, the largest industrial regions in the country. The terms of the transactions were not disclosed. Corrugated packaging is a strategic business for International Paper in EMEA and offers customers high-quality packaging solutions in the industrial, fresh fruit and vegetable, and e-commerce segments. The two businesses will become part of International Paper effective April 1, 2021.

About International Paper
International Paper (NYSE: IP) is a leading global producer of renewable fiber-based packaging, pulp and paper products with manufacturing operations in North America, Latin America, Europe, North Africa and Russia. We produce corrugated packaging products that protect and promote goods, and enable world-wide commerce; pulp for diapers, tissue and other personal hygiene products that promote health and wellness; and papers that facilitate education and communication. We are headquartered in Memphis, Tenn., employ approximately 48,000 colleagues and serve more than 25,000 customers in 150 countries. Net sales for 2020 were $21 billion. For more information about International Paper, our products and global citizenship efforts, please visit internationalpaper.com

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SOURCE International Paper

Exacta Systems Signs Historical Horse Racing Agreement With Scientific Games

PR Newswire

BOYNTON BEACH, Fla., March 30, 2021 /PRNewswire/ — Exacta Systems announced today that it signed an agreement with Las Vegas-based gaming equipment supplier Scientific Games to bring game content, featured on Scientific Games’ award-winning game cabinets, onto the Exacta Historical Horse Racing (HHR) system.

Jeremy Stein, Chief Executive Officer at Exacta Systems, remarked “Exacta Systems is thrilled to partner with Scientific Games for the historical horse racing market. Given that their games are top performers in casinos throughout North America, we expect them to be very popular with our customers in HHR.”

Bob Parente, Executive Vice President and Chief Revenue Officer at Scientific Games, commented, “We are excited about our integration with Exacta Systems. It is a terrific opportunity to bring Scientific Games’ world-class content to historical horse racing in Virginia.”

About Exacta Systems: Exacta Systems is a leader in the historical horse racing and central determinate technology markets. Its Exacta Connect product supports a “build once, deploy many” regulatory approved system that delivers engaging and entertaining games across different central determinate market segments. Exacta’s best-of-breed HHR library, combined with its open system platform that accommodates third party-manufacturer content, ensures that HHR customers enjoy a second-to-none entertainment experience. For more information about the company and the Exacta historic horse racing system, visit www.exactasystems.com.

About Scientific Games: Scientific Games Corporation (NASDAQ: SGMS) is a world leader in entertainment offering dynamic games, systems and services for casino, lottery, social gaming, online gaming and sports betting. Scientific Games offers the gaming industry’s broadest and most integrated portfolio of game content, advanced systems, cutting-edge platforms and professional services. Committed to responsible gaming, Scientific Games delivers what customers and players value most: trusted security, engaging entertainment content, operating efficiencies and innovative technology. For more information, please visit scientificgames.com.

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SOURCE Exacta Systems

U.S. FDA Accepts AbbVie’s New Drug Application for Atogepant for the Preventive Treatment of Migraine

– If approved, atogepant will be the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine[1]

– In the Phase 3 ADVANCE trial for the preventive treatment of migraine in adults with 4-14 migraine days, all active treatment arms of atogepant met their primary endpoint, and the 30 and 60 mg doses met all six secondary endpoints with statistical significance[1]

– Migraine is a debilitating neurological disease affecting 39 million people in the U.S.[2]

– The atogepant application demonstrates AbbVie’s longstanding commitment to providing multiple migraine treatment options, including BOTOX® (onabotulinumtoxinA), a preventive treatment for those with chronic migraine, and UBRELVY® (ubrogepant), an acute treatment for adults with migraine

PR Newswire

NORTH CHICAGO, Ill., March 30, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), for the preventive treatment of migraine in adults who meet criteria for episodic migraine. AbbVie anticipates a regulatory decision in late Q3 2021.

Migraine is a complex, chronic disease with attacks that are often incapacitating and can include headache pain as well as neurologic and autonomic symptoms.3 Migraine symptoms and severity range widely among individuals.

The NDA is supported by data from a robust clinical program evaluating the efficacy, safety and tolerability of orally administered atogepant in nearly 2,500 patients who experience 4-14 migraine days per month including but not limited to the pivotal Phase 3 ADVANCE study, the pivotal Phase 2b/3 study, and the Phase 3 long-term safety study.

“With the integration of Allergan, AbbVie is now a committed leader in migraine with an almost 25-year history in migraine research. We look forward to potentially adding a new treatment option to our portfolio that will help more people with migraine,” said Michael Gold, MD, vice president, neuroscience development, AbbVie. “We believe atogepant is an advancement with the potential to offer meaningful benefits as a safe, effective oral preventive treatment option. Despite the availability of other migraine treatment options, the medical community and people living with migraine recognize the unmet need of those who face the unpredictable and debilitating realities of this disease.”

In the Phase 3 ADVANCE study, all active treatment arms of atogepant met their primary endpoint of a statistically significant reduction in mean monthly migraine days over a 12-week treatment period. Also, the 30 and 60 mg doses met all six secondary endpoints with statistical significance. This study followed positive results from the Phase 2b/3 study that met the same primary endpoint across all doses and dosing regimens. The Phase 3 long-term safety study evaluated safety and tolerability of 60 mg oral atogepant administered daily over 52 weeks. The Phase 3 long-term safety study will be presented at the American Academy of Neurology 2021 Virtual Annual Meeting. Results from the Phase 2b/3 study and the Phase 3 ADVANCE study were previously announced.1,4

About the Phase 3 ADVANCE Study
The pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was designed to evaluate the efficacy, safety, and tolerability of oral atogepant for the preventive treatment of migraine in those with 4 to 14 migraine days per month. A total of 910 patients were randomized to one of four treatment groups evaluating 10 mg, 30 mg, and 60 mg of atogepant once daily, or placebo. Efficacy analyses were based on the modified intent-to-treat (mITT) population of 873 patients. 

The primary endpoint was change from baseline in mean monthly migraine days across the 12-week treatment period. All atogepant dose groups met the primary endpoint and demonstrated statistically significant reductions in mean monthly migraine days compared to placebo. Patients treated in the 10 mg, 30 mg, and 60 mg atogepant arms experienced a decrease of 3.69, 3.86, and 4.2 days, respectively, compared to patients in the placebo arm, who experienced a decrease of 2.48 days (all dose groups vs. placebo, p=<.0001).

A key secondary endpoint measured the proportion of patients that achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period. The trial demonstrated that 55.6%, 58.7%, and 60.8% of patients in the 10 mg, 30 mg, and 60 mg atogepant arms, respectively, achieved at least a 50% reduction, compared to 29.0% of patients in the placebo arm (all dose groups vs. placebo, p=<.0001). 

All doses were well tolerated. The most common adverse events reported with a frequency ≥ 5% in at least one atogepant treatment arm, and greater than placebo, were constipation (6.9-7.7% across all doses vs. 0.5% for placebo), nausea (4.4-6.1% across all doses vs. 1.8% for placebo), and upper respiratory tract infection (3.9-5.7% across all doses vs. 4.5% for placebo). The majority of cases of constipation, nausea and upper respiratory tract infection were mild or moderate in severity and did not lead to discontinuation.

The study results were announced in a July 2020press release and presented at the 2020 Virtual Migraine Trust International Symposium.

About the Phase 2b/3 CGP-MD-01 Study
The pivotal Phase 2b/3 clinical trial evaluating the efficacy, safety and tolerability of orally administered atogepant demonstrated that all active treatment arms met the primary endpoint with a statistically significant reduction from baseline in mean monthly migraine days compared with placebo across the 12-week treatment period in those with 4 to 14 migraine days per month. The results were announced in a June 2018press release and were also presented at the 2019 American Headache Society Annual Meeting.

About the Phase 3 Long-Term Safety Study
The Phase 3, multicenter, randomized, open-label study evaluated the long-term safety and tolerability of 60 mg oral atogepant administered daily over 52 weeks for the preventive treatment of migraine in adults with 4-14 migraine days per month. Further details on the study will be presented at the American Academy of Neurology 2021 Virtual Annual Meeting.

About Migraine
Migraine is a complex, chronic disease with recurrent attacks that are often incapacitating and characterized by headache pain as well as neurologic and autonomic symptoms.2 It is highly prevalent, affecting more than 1 billion people worldwide, including 39 million people in the U.S. alone,2 and is the highest cause of disability worldwide for people under 50 years of age.5,6 Due to the unpredictability and fluctuation of attack frequency and severity, migraine substantially impacts many aspects of an individual’s life both during and between attacks. Daily activities, work, school and personal relationships can be negatively affected, leading to a significant burden on the person with migraine, their family, friends, employers and healthcare systems.

About Atogepant
Atogepant is an investigational orally administered, CGRP receptor antagonist (gepant) specifically developed for the preventive treatment of migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks and selective CGRP receptor antagonists confer clinical benefit in migraine.

About AbbVie Leadership in Migraine
AbbVie, a leader in the migraine space, markets BOTOX® (onabotulinumtoxinA), the first FDA-approved, preventive treatment for adults with chronic migraine and UBRELVY® (ubrogepant), the first FDA-approved oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), which is indicated for the acute treatment of migraine with or without aura in adults.

BOTOX® Indication
BOTOX® is a prescription medicine that is injected into muscles and used:

  • To prevent headaches in adults with Chronic Migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older

It is not known whether BOTOX® is safe and effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).


IMPORTANT SAFETY INFORMATION

BOTOX® may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing

There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat chronic migraine.

BOTOX® may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX®. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Do not receive BOTOX® if you: are allergic to any of its ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

The dose of BOTOX® is not the same as, or comparable to, any other botulinum toxin product.

Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX® should be discontinued.

Tell your doctor about all your muscle or nerve conditions such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX®.

Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX® passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® in the past.

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX® include: dry mouth, discomfort or pain at injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes; drooping eyebrows.

For more information refer to the Medication Guide or talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see BOTOX® full Prescribing Information, including Boxed Warning and Medication Guide.

UBRELVY® Indication

UBRELVY (ubrogepant) is indicated for the acute treatment of migraine with or without aura in adults. UBRELVY is not indicated for the preventive treatment of migraine.


IMPORTANT SAFETY INFORMATION

Contraindication: Concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).

Adverse Reactions: The most common adverse reactions were nausea (4%) and somnolence (3%).

Please see UBRELVY full Prescribing Information.

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on TwitterFacebookLinkedIn or Instagram.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and effectively integrate Allergan’s businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

1. AbbVie. (2020, July 29). AbbVie Announces Positive Phase 3 Data for Atogepant in Migraine Prevention. https://news.abbvie.com/news/press-releases/abbvie-announces-positive-phase-3-data-for-atogepant-in-migraine-prevention.htm
2. Migraine Research Foundation. Migraine Facts. https://migraineresearchfoundation.org/about-migraine/migraine-facts/#:~:text=Migraine%20is%20an%20extraordinarily%20prevalent,U.S.%20and%201%20billion%20worldwide.
3. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
4. Allergan, an AbbVie Company. (2018, June 11). Allergan’s Oral CGRP Receptor Antagonist Atogepant Demonstrates Robust Efficacy and Safety in Episodic Migraine Prevention in a Phase 2b/3 Clinical Trial. https://www.prnewswire.com/news-releases/allergans-oral-cgrp-receptor-antagonist-atogepant-demonstrates-robust-efficacy-and-safety-in-episodic-migraine-prevention-in-a-phase-2b3-clinical-trial-300663770.html 
5. GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390:1211-1259.
6. Steiner TJ, Stovner LJ, Vos T, Jensen R, Katsarava Z. Migraine is first cause of disability in under 50s: Will health politicians now take notice? J Headache Pain. 2018;19:17.

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SOURCE AbbVie

First Tommy John in North Texas to Open in Southlake Town Square

Things are about to get even more comfortable with opening of cult favorite underwear store

PR Newswire

SOUTHLAKE, Texas, March 30, 2021 /PRNewswire/ — Tommy John, the comfort-focused lifestyle brand committed to solving the problems men and women have with their underwear and apparel, is opening its first location in North Texas, choosing Southlake Town Square to make its debut. The store, the brand’s second in Texas, will open Saturday, April 3.

“Brands that have a lot of buzz online are looking at destinations like Southlake Town Square that are highly attuned to shoppers’ experiences,” noted Jason Kasal, vice president and senior leasing director – western division with Retail Properties of America, Inc. (“RPAI”), owner and operator of Southlake Town Square. “Our guests know that when they come to the Square, they can get first-hand experience with the products they’ve been following and hearing about, and retailers have this unique opportunity to broaden their brand experience with a front door in a walkable, well-edited collection of stores.”

Tommy John was founded in 2008 by married entrepreneurs, Tom Patterson and Erin Fujimoto. Prior to Tommy John, Patterson was a medical device salesman that grew frustrated with his undershirts constantly coming untucked. With Fujimoto’s help, they set out to redesign men’s base layers from scratch with a focus on premium fabric, innovative fit and problem-solving functionality. “No Adjustment Needed” is Tommy John’s slogan, reflecting the brand’s commitment to comfort. Tommy John has expanded its product offering to include women’s underwear bras and apparel, made with the same dedication to fabrics, fit and function.

“If there’s one thing we can all agree on after this past year, it’s the value of comfort,” said Patterson. “We’re so excited to open our doors to the Southlake Town Square community and we look forward to giving even more people the opportunity to live life more comfortably with Tommy John.”

This is the first North Texas location, and second Texas store, for Tommy John, which is located in a 1,925-square-foot space at 1426 Main Street, across from LUSH. The store opening comes amidst a four-year-long partnership Tommy John has with the Dallas Cowboys, and an extremely positive reception for the brand from Texans. The Tommy John store at Southlake Town Square is the fifth retail location for the fast-growing brand.

About Southlake Town Square

Located in the heart of the Dallas-Fort Worth Metroplex in Southlake, Texas, Southlake Town Square is owned and operated by a subsidiary of RPAI. This 130-acre, open-air, mixed-use development boasts more than 120 specialty retail shops and restaurants, including the first Market by Macy’s in the country, Apple, Madewell, Anthropologie, lululemon and Sephora, an upscale urban Hilton Hotel, offices, city and county government buildings, a U.S. Post Office and residential brownstones. To learn more, please visit SouthlakeTownSquare.com or call 817- 329-5566. Connect socially with Southlake Town Square online via its Facebook or Instagram.

About RPAI

Retail Properties of America, Inc. is a REIT that owns and operates high quality, strategically located open-air shopping centers, including properties with a mixed-use component. As of December 31, 2020, the Company owned 102 retail operating properties in the United States representing 20.0 million square feet. The Company is publicly traded on the New York Stock Exchange under the ticker symbol RPAI. Additional information about the Company is available at www.rpai.com.

Editor’s note: High-res photos of Tommy John in Southlake Town Square are available here.

Media Contacts:
Suzanne Gentry Flodin
214.500.4289
[email protected] 

Rachel Hedstrom 
972.365.7741
[email protected]

 

 

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SOURCE Southlake Town Square