Stockwinners Market Radar for June 24, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:17 EDT SPDR Gold Shares holdings fall from 1,046.45MT to 1,042.87MT - This is the 2nd consecutive decline and a 1-week low level of holdings.

19:15 EDT Genentech's Actemra receives emergency use authorization from FDA - Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has issued an Emergency Use Authorization for intravenous Actemra for the treatment of COVID-19 in hospitalized adults and pediatric patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. The EUA is based on results from four randomized, controlled studies that evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. The results of these studies suggest that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support. "Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalizations from severe forms of the disease," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We are pleased that Actemra is now authorized as an option that may help improve outcomes for adults and children hospitalized with COVID-19 in the United States."

18:24 EDT Vista Outdoor CEO: We can't fill the demand that sits in the marketplace - In an interview on CNBC's Mad Money, Chris Metz said Vista's Outdoor products business had a record year. The company can't produce enough products to meet demand, he noted. New product innovation, online efforts have been driving sales, he added. Acquisitions are going to be a big part of Vista's value proposition going forward, according to Metz, with an emphasis on exploring tuck-in acquisitions. "We're just in the beginning of our growth," he said.

17:46 EDT Nike provides growth targets through 2025 - Sees sustained revenue growth going forward. Sees high-single digits to low-double digits revenue growth on average through 2025. Sees EBIT margin reaching high teens by 2025. Sees EPS growth of mid-to-high teens on average through 2025.

17:40 EDT Granite awarded $16 rehabilitation project at Anchorage International Airport - Granite announced that it has been awarded a bid-build contract to rehabilitate three taxiways at Anchorage International Airport by the Alaska Department of Transportation and Public Facilities in Anchorage, Alaska. The $16M contract is anticipated to be included in Granite's second quarter committed and awarded projects. The scope of work consists of cold planing and replacing 60,000 tons of asphalt pavement, asphalt surface treatment, storm drain improvements, and the replacement and improvement of taxiway lighting and signage. Granite's Lang Street Hot Plant will supply the 60,000 tons of hot-mix asphalt for the project. The rehabilitation work is expected to begin in July 2021 and projected to be completed by September 2022.

17:36 EDT Forum Merger III stockholders approve combination with Electric Last Mile - Forum Merger III Corporation (FIII) and Electric Last Mile, Inc. (ELMS) announced that Forum's stockholders have approved all proposals related to the companies' previously announced business combination. At a special meeting of Forum's stockholders held today, approximately 99% of the votes cast, representing approximately 67% of Forum's outstanding shares as of the record date for the meeting, voted to approve the business combination with ELMS. The formal results of the vote will be included on a Form 8-K to be filed with the U.S. Securities and Exchange Commission. The closing of the business combination is anticipated to take place on June 25, 2021, subject to the satisfaction of certain customary closing conditions. The combined company will be renamed Electric Last Mile Solutions, Inc., and its common stock and warrants are expected to begin trading on the Nasdaq Stock Market under the ticker symbols "ELMS" and "ELMSW", respectively, on June 28, 2021.

17:31 EDT BankFinancial expands share repurchase program by 900,000 shares - BankFinancial increased the total number of shares currently authorized for repurchase under the Share Repurchase Program by 900,000 shares. As of June 24, a total of 99,661 shares remained authorized for purchase pursuant to the previous share repurchase authorization. The total number of shares authorized for repurchase is 999,661. The share repurchase authorization remains in effect through November 15.

17:24 EDT FedEx says B2B volumes have recovered to pre-COVID levels - Says European recovery will return to pre-pandemic levels later in 2021.

17:12 EDT FedEx CEO sees operating margins expanding in FY22 - Comments taken from Q4 earnings conference call.

16:38 EDT Fed releases annual bank stress test results, to end COVID event restrictions - The Federal Reserve Board released the results of its annual bank stress tests, which showed that large banks continue to have strong capital levels and could continue lending to households and businesses during a severe recession. "Over the past year, the Federal Reserve has run three stress tests with several different hypothetical recessions and all have confirmed that the banking system is strongly positioned to support the ongoing recovery," said Vice Chair for Supervision Randal Quarles. All 23 large banks tested remained well above their risk-based minimum capital requirements and as laid out previously by the Board, the additional restrictions put in place during the COVID event will end. All large banks will be subject to the normal restrictions of the Board's stress capital buffer, or SCB, framework. Publicly traded companies in the space include Bank of America (BAC), Citi (C), Goldman Sachs (GS), JPMorgan (JPM), Morgan Stanley (MS), U.S. Bancorp (USB) and Wells Fargo (WFC). Reference Link

16:35 EDT IGC no longer requires Caesars to sell Horseshoe Hammond following amended order - The Indiana Gaming Commission, or IGC, amended its order requiring Caesars to sell a third casino asset in the state. As a result, Caesars will continue to own and operate Horseshoe Hammond, Indiana Grand, Harrah's Hoosier Park, and its three off-track betting locations. Caesars Entertainment recently closed on the sale of Tropicana Evansville and expects to close on the sale of Caesars Southern Indiana sometime in Q3.

16:33 EDT Deluxe, Microsoft to collaborate over small business HR, payroll solutions - Deluxe (DLX) announced a collaboration with Microsoft (MSFT) to bring the Deluxe small business human resources and payroll solutions to Microsoft Dynamics 365 Business Central. The collaboration brings together the two companies to further accelerate financial and accounting solutions for small businesses. "As your business grows in both size and complexity and your customers expect better and faster service, the tools that once supported you may now be standing in your way," said Garry Capers, President of Cloud Solutions for Deluxe. "Whether the result is lost sales, customer dissatisfaction, or compliance risks, failing to update your technology can be a costly decision. Deluxe solutions for small businesses, from incorporation services to payroll, logo creation to website development, help entrepreneurs and business owners grow and thrive in the marketplace." "Through the integration of Deluxe small business solutions, we have eliminated the need for manual importing or exporting and reconciliation of payroll data by unifying and automating our payroll solution with the financial management capabilities in Microsoft Dynamics 365 Business Central. This gives business owners more controls, efficiency and access through our single unified solution," Capers continued.

16:32 EDT KBR awarded $194.3M Air Force task order - KBR won a $194.3M task order to research, develop, test, and analyze the design and fabrication of microelectronics components, verifying and validating their trustworthiness for the U.S. Air Force Research Laboratory's, or AFRL, Trusted Electronics Branch, or RYDT. Under the Security and Trustworthy Foundations for Electronics Resurgence, or STryFER, task order, KBR's efforts will include multidisciplined research and development of design best practices and methodologies for trusted systems in the digital and analog realm. The company will also develop unique and science-driven counterfeit detection schemes through microelectronic device characterization methodology, and advanced fabrication and packaging schemes for trusted microelectronics. The Air Force Installation Contracting Center, 774 Enterprise Sourcing Squadron awarded the cost-plus-fixed-fee task order through the DoD Information Analysis Center's, or IAC, multiple award contract, an indefinite delivery, indefinite quantity vehicle for complex, integrated professional projects. KBR will carry out these duties at Wright-Patterson Air Force Base, as well as other locations over the next five years. The company has supported AFRL/RYDT and predecessor organizations since 2012.

16:19 EDT Masonite plans new manufacturing facility in South Carolina - Masonite plans to invest in a new door manufacturing facility in Fort Mill, SC. Fort Mill was selected in part due to its proximity to customers and suppliers, workforce quality and availability, and pro-business climate. The new 370,000 square foot facility will produce doors for the North American residential housing market and is expected to employ more than 220 people beginning in early 2022.

16:17 EDT Iqvia launches Clinical Data Analytics Suite - Iqvia "introduced Clinical Data Analytics Suite, a new SaaS-based clinical data analytics platform that combines structured and unstructured data from clinical trials into a single, standardized setting for easier access and use. This produces a scalable repository, that helps meet regulatory requirements, for stakeholders to investigate operational and clinical data. It also drives faster predictive analytics using AI/ML, enabling smarter decisions across all parts of a clinical trial."

16:15 EDT Tonix announces advancement of construction of commercial-scale vaccine plant - Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, said that plans are advancing to construct a commercial-scale manufacturing facility to develop and manufacture vaccines in the Bitterroot Valley, according to a press release issued by the company. Lederman has said that once the facility is completed, Tonix expects to create "many high-tech bioscience jobs." The new Montana facility is intended to develop and produce Tonix's vaccine candidates, including TNX-1800, a potential COVID-19 vaccine. "One of the things that the COVID-19 pandemic exposed was major shortcomings in U.S. domestic vaccine development and manufacturing capabilities. Tonix is striving to be a pioneer in American made vaccine development and production. We believe it is vital to bring these skills and high-tech jobs back to the U.S. both in the fight against the COVID-19 pandemic and it's long lasting effects, and to prepare for prospective future pandemics," said Lederman.

16:13 EDT Terns initiates dosing in study of VAP-1 Inhibitor TERN-201 in NASH treatment - Terns Pharmaceuticals announced the initiation of patient dosing in the AVIATION Trial, a Phase 1b clinical trial evaluating TERN-201, an orally-administered, highly selective inhibitor of vascular adhesion protein-1 VAP-1 in patients with NASH. The AVIATION Trial is a multi-center, randomized, double-blind, dose-ranging, placebo-controlled, proof of concept, adaptive, Phase 1b clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of TERN-201 in patients with presumed non-cirrhotic NASH and a cT1 value of greater than 800ms. Corrected T1, or cT1, is a magnetic resonance-based imaging test measuring liver inflammation and fibrosis that has been associated with clinical outcomes and liver histology. The primary objective of the AVIATION Trial is to evaluate the safety and tolerability of TERN-201 versus placebo when given for 12 weeks in patients with NASH. The clinical trial will be conducted in two parts: Part 1 of the trial has begun with a dose of 10 mg as compared to placebo while Part 2 is expected to enroll additional dose cohorts of TERN-201 based on an interim assessment of the 10 mg cohort. Each part of the AVIATION Trial is planned to include approximately 20 patients receiving each of the designated doses of TERN-201 and approximately 10 patients receiving placebo. The clinical trial will also explore the effects of TERN-201 on NASH imaging biomarkers (such as cT1) and NASH blood biomarkers. Preliminary topline 12-week data from Part 1 and Part 2 of the AVIATION Trial are expected in 1H 2022 and 2H 2022, respectively. "Increasing evidence points to the role of VAP-1 in recruiting white blood cells to the liver as a key factor driving liver inflammation and fibrosis in people living with NASH," said Erin Quirk, M.D., President, Chief Medical Officer and Head of R&D at Terns, "We are excited by TERN-201's selective VAP-1 inhibition and its potential anti-inflammatory and anti-fibrotic effects which may complement the anti-steatotic activity seen with our other product candidates. Initiation of the AVIATION Trial is an important step towards a single once-daily pill as an effective NASH treatment."

16:10 EDT FedEx falls about 4% to $291.58 after Q4 results and guidance

16:08 EDT Revolution Medicines publishes data on mTORC1-selective inhibitors - Revolution Medicines announced the publication of an original scientific paper in Nature Chemical Biology describing anti-tumor effects of bi-steric mTORC1-selective inhibitors that potently suppress phosphorylation of 4EBP1, a translational regulator of oncogene expression. In preclinical models of cancers with mutations that drive mTORC1 hyperactivation, a series of bi-steric inhibitors demonstrated the favorable anti-tumor effects and tolerability of deeply and selectively inhibiting mTORC1 compared to earlier generations of mTOR inhibitors. Mutations that cause hyperactive mTORC1 signaling are found in tumors with and without co-existent RAS mutations. This original research was led by scientists at Revolution Medicines and conducted in collaboration with the Neal Rosen Lab at the Memorial Sloan Kettering Cancer Center, as well as researchers from McGill University and The Karolinska Institute. Revolution Medicines recently advanced RMC-5552, the company's investigational first-in-class bi-steric mTORC1 inhibitor, into clinical development. RMC-5552 is a potent and selective inhibitor of mTORC1 that is being developed as an anti-cancer therapeutic for patients with solid tumors that exhibit hyperactivation of the mTOR pathway, including certain RAS-addicted cancers. The compound is designed to inhibit mTORC1 and thereby protect the natural tumor suppressor activity of 4EBP1, without the undesirable inhibition of mTORC2. RMC-5552 has demonstrated anti-tumor activity in a wide variety of preclinical models. Revolution Medicines has also reported in vivo data demonstrating that RMC-5552 may increase anti-tumor activity in combination with KRASG12C inhibitors in lung and colon cancers harboring both KRAS mutations and co-mutations in the mTOR signaling pathway that can cause resistance to single agent RAS inhibition.

16:06 EDT FedEx CEO says optimistic about future and meeting 'strong demand' - CEO Frederick W. Smith says: "We continue to play an important role in global economic recovery and the delivery of COVID-19 vaccines and relief supplies throughout the U.S., Canada and more than 35 other countries. I am optimistic about the future of FedEx as we continue to innovate for our customers and meet strong demand for our global transportation network and capabilities."

16:05 EDT Marcus & Millichap unit brokers $69.1M central Phoenix sale - Institutional Property Advisors, a division of Marcus & Millichap, announced the sale of Level at Sixteenth, a 240-unit, mid-rise apartment community in the urban core of Phoenix, Arizona. The property traded at $69.1M, or $287,917 per unit. "Transformed from an obsolete 1950s-vintage retail center into a luxury multifamily community in 2010, Level at Sixteenth is a modern, podium-constructed asset with a recognizable value-add opportunity," said Steve Gebing, IPA executive managing director. "The scarcity of developable land in the area supports investment by providing shelter from future multifamily competition." Gebing and IPA executive managing director Cliff David represented the seller, an affiliate of Abacus Capital Group and procured the buyer, Sares Regis Group.

16:02 EDT Axonics files PMA supplement with FDA for implantable sacral neurostimulator - Axonics has filed a premarket approval supplement with the FDA for its newly developed, long-lived, non-rechargeable sacral neuromodulation implantable neurostimulator. Axonics has designed its new non-rechargeable SNM system to replicate key features of its currently marketed, FDA-approved rechargeable SNM system, which provides patients with clinically significant, durable symptom relief and high levels of satisfaction. Raymond W. Cohen, chief executive officer of Axonics, commented, "Since the company's founding, we have focused on developing best-in-class, patient-centric SNM solutions. Our rechargeable system introduced innovations to the SNM category that clinicians and patients had been requesting for years - longevity in the body, MRI compatibility, a miniaturized implant and a fuss-free patient remote control that is easy for patients to use. Our new non-rechargeable system is similarly groundbreaking - a relatively small and thin INS with an expected life in the body that is more than double the competitor's non-rechargeable device. We are confident that the introduction of our non-rechargeable device will continue to drive market expansion and advance Axonics on its path to SNM market leadership."

15:56 EDT Wendy's announces new plant-based sandwich 'Spicy Black Bean Burger' - Wendy's (WEN) announced the addition of a new plant-based sandwich, the Spicy Black Bean Burger. "Beginning June 28, Wendy's fans in Columbus, Pittsburgh and Jacksonville who are craving extra heat this summer can enjoy texture, crunch and flavor in every Spicy Black Bean Burger bite while supplies last," said Carl Loredo, U.S. Chief Marketing Officer for Wendy's. The Fly notes that Wendy's competes with McDonald's (MCD) in the fast food space, and Beyond Meat (BYND), which is down 2.6% in late afternoon trading, is a suppler of a plant- based meatless burger alternative.

15:33 EDT Incyte announces ODAC vote to delay retifanlimab regulatory decision - Incyte announced the outcome of a meeting of the Oncologic Drugs Advisory Committee, or ODAC, of the FDA, which reviewed the Biologics License Application, or BLA, for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal, or SCAC, who have progressed on, or who are intolerant of, platinum-based chemotherapy. The Committee voted 13-4 that a regulatory decision on retifanlimab for the treatment of advanced or metastatic SCAC should be deferred until further data are available from clinical trial POD1UM-303, a confirmatory trial in platinum-naive advanced SCAC that is currently underway.

14:59 EDT Ultragenyx treatment of glycogen storage disease type III granted orphan status - Ultragenyx Pharmaceutical's treatment of glycogen storage disease type III was granted orphan designation by the FDA, according to a post to the agency's website. Reference Link

14:46 EDT E Home Household Service Holdings Ltd trading halted, volatility trading pause

14:15 EDT Forest Road Acquisition holders approve three-way business combination - Forest Road Acquisition (FRX) announced that its stockholders have voted to approve the proposed three-way business combination with The Beachbody Company Group and Myx Fitness Holdings at its special meeting of stockholders. The business combination is expected to close on June 25. As previously announced, the combined company will be named Beachbody Company and its common stock and warrants are expected to start trading on the New York Stock Exchange under the new ticker symbols "BODY" and "BODY WS," respectively, on June 28.

14:14 EDT Biden, Harris announce support for $1.2T Bipartisan Infrastructure Framework - President Biden and Vice President Harris announced their support for the Bipartisan Infrastructure Framework, which the White House calls "the largest long-term investment in our infrastructure and competitiveness in nearly a century - an investment that will make our economy more sustainable, resilient, and just." The $1.2 trillion Bipartisan Infrastructure Framework is "a critical step in implementing President Biden's Build Back Better vision," the White House said in a fact sheet. The Plan "makes transformational and historic investments in clean transportation infrastructure, clean water infrastructure, universal broadband infrastructure, clean power infrastructure, remediation of legacy pollution, and resilience to the changing climate. Cumulatively across these areas, the Framework invests two-thirds of the resources that the President proposed in his American Jobs Plan," the White House added. Reference Link

13:18 EDT Royal Caribbean names Silvia Garrigo as chief ESG officer - Royal Caribbean Group announced that Silvia Garrigo will join the company June 28 as Senior Vice President and Chief Environmental, Social and Governance Officer, reporting to Chairman and CEO Richard Fain. "I am thrilled to have Silvia join to help us continue our leadership and commitment to ESG," said Fain. "Silvia has advised several companies on purpose-driven and practical ESG strategies and programs, and she understands the interplay of legal, geo-political, social and environmental issues in a global business context. Bringing her to Royal Caribbean Group affirms our commitment to going above and beyond for the health and success of our planet and our people."

12:46 EDT President Biden says 'struck a deal' on infrastructure - President Joe Biden tweeted: "We've struck a deal. A group of senators - five Democrats and five Republicans - has come together and forged an infrastructure agreement that will create millions of American jobs." Potential beneficiaries of infrastructure spending plans in the U.S. include Vulcan Materials (VMC), U.S. Steel (X), Martin Marietta (MLM), Vale (VALE), Cleveland-Cliffs (CLF), Nucor (NUE), Caterpillar (CAT), Deere (DE) Oshkosh (OSK) and Freeport McMoRan (FCX).

12:06 EDT GeoPark co-founder initiating 'vote no' campaign against directors - Gerald O'Shaughnessy of GP Investments, owner of 10.7% of GeoPark's outstanding shares, issued an open letter to the company's shareholders announcing that he was is initiating a "vote no" campaign against four directors of GeoPark at the annual meeting of shareholders. The letter states in part: "As many of you know, I co-founded GeoPark in 2002 and currently hold 10.7% of the outstanding shares of the Company, making me its second largest shareholder. I am writing to you now because I am deeply concerned about the path the Company is currently on. In my view, the issues plaguing the Company stem from a common source: for years, Jim Park has been allowed to operate as an imperial CEO, abetted by certain members of the Board of Directors who have blindly followed Mr. Park and failed to exert basic oversight over management or the Company's strategy...This is why I urge you to vote AGAINST incumbent directors Robert Bedingfield, Constantin Papadimitriou, Pedro Aylwin and James Park at the upcoming AGM to be held on July 15, 2021. A vote against these incumbents will send a clear message to the Board that it must listen to concerned shareholders and it must not continue down its current path.

12:01 EDT Microsoft introduces Windows 11 with Teams, Game Pass integration - Microsoft unveiled Windows 11, which is "designed to bring you closer to what you love." "We've simplified the design and user experience to empower your productivity and inspire your creativity, the company said in a blog post. "With Windows 11, we're excited to introduce Chat from Microsoft Teams integrated in the taskbar," the post continued. "Now you can instantly connect through text, chat, voice or video with all of your personal contacts, anywhere, no matter the platform or device they're on, across Windows, Android or iOS. If the person you're connecting to on the other end hasn't downloaded the Teams app, you can still connect with them via two-way SMS." The company added that Windows 11 "unlocks the full potential" of a PC's hardware for gaming, adding that Xbox Game Pass will be built into the OS via the Xbox app. "We're also pumped to announce that we are bringing Android apps to Windows for the first time," the company said. "Starting later this year, people will be able to discover Android apps in the Microsoft Store and download them through the Amazon Appstore - imagine recording and posting a video from TikTok or using Khan Academy Kids for virtual learning right from your PC." "For IT, Windows 11 is built on the consistent, compatible and familiar Windows 10 foundation you know," Microsoft added. "You'll plan for, prepare and deploy Windows 11 just as you do today with Windows 10. Upgrading to Windows 11 will be like taking a Windows 10 update." Reference Link

12:00 EDT DoubleVerify falls -9.3% - DoubleVerify is down -9.3%, or -$4.00 to $39.08.

12:00 EDT X Financial rises 11.6% - X Financial is up 11.6%, or $1.12 to $10.78.

12:00 EDT Semrush rises 18.1% - Semrush is up 18.1%, or $3.67 to $23.86.

11:38 EDT Kroger raises quarterly dividend 17% to 21c per share - The Kroger Co.'s Board of Directors approved a dividend increase from 72c to 84c per year. The next quarterly dividend of 21c per share will be paid on September 1, 2021 to shareholders of record as of the close of business on August 13, 2021.

11:22 EDT Microsoft unveils Windows 11 with direct Teams integration - Microsoft is hosting a Windows 11 unveiling event, during which the company has officially noted the new OS will be dubbed Windows 11 as well as showed off a new design, Start menu and features that include Teams integration directly into Windows, according to live blogs of the event.

11:16 EDT Moxian Inc trading halted, volatility trading pause

11:02 EDT Merck appoints Michael Klobuchar as CSO - Merck announced that Michael Klobuchar has been appointed executive vice president and chief strategy officer, a newly created role, effective July 5, 2021. As chief strategy officer, Klobuchar will become a member of Merck's Executive Committee and lead the advancement and execution of the company's strategy. Klobuchar is currently senior vice president, Merck Research Laboratories Finance and Global Project and Alliance Management.

10:23 EDT Some Vimeo contracts renewing with lower pricing says Frost & Sullivan's Rayburn - Dan Rayburn, a principal analyst at Frost & Sullivan, said via Twitter that some Vimeo contracts are renewing with "much lower pricing in Q2, compared to 2020. In some cases, pricing down by 75%. Also interesting to see Vimeo just slashed pricing on their OTT "growth" plan down to $500 a month and cut the bandwidth allocation down to 60TB." Reference Link

10:05 EDT Digital Brands announces channel expansion into Amazon marketplace - Digital Brands (DBGI) announced that they are expanding their already expansive e-commerce ecosystem by launching a select group of brands on Amazon (AMZN) this Fall. Laura Dowling, DBG's Chief Marketing Officer, said, "Amazon adds an additional customer acquisition channel to our marketing strategy. We have reviewed data from several apparel brands that have leveraged Amazon's marketplace and we are excited about the opportunity this channel adds to our customer acquisition and brand awareness... Amazon is a juggernaut in the retail industry regardless what category you are in. It is imperative to any brand to have a well-designed, high traffic presence on the platform to add to brand recognition and promote sales both through the platform and on other channels the bottom line," said Laura Dowling. "Our data gives DBG great confidence we can hit above average conversion rates at a cost for customer acquisition compared to industry standards, we look forward to sharing the results of this project in the coming months."

10:00 EDT Talos Energy falls -5.8% - Talos Energy is down -5.8%, or -$1.08 to $17.57.

10:00 EDT Rite Aid falls -14.6% - Rite Aid is down -14.6%, or -$2.99 to $17.43.

10:00 EDT Sprinklr rises 13.6% - Sprinklr is up 13.6%, or $2.40 to $20.00.

09:51 EDT DarioHealth selected as digital health provider by Coastal Family Health Center - DarioHealth announced earlier that it has been selected as digital health provider by Coastal Family Health Center, a local, non-profit healthcare network providing comprehensive primary care to patients across several underserved counties in and around the Mississippi Gulf Coast. The initial focus of the engagement will be Dario's Remote Patient Monitoring, or RPM, solution for hypertension and the prevention of related cardiac events. "Today's announcement is just the beginning of an exciting set of new Business-to-Business - B2B- channel clients that we intend to announce over the coming weeks with providers, employers and payers. We are very pleased to have been selected by Coastal Family Health Center for their digital health needs following a rigorous evaluation process that included many of the major competitors in our industry. We believe our selection by Coastal Family Health Center reflects not only the strength of our RPM capabilities, but also our differentiated 'customer-first' approach that allows us to tailor our program to their specific needs while opening up access to healthcare to support patients when and how they need," stated Rick Anderson, President and General Manager of North America at DarioHealth.

09:47 EDT Talos Energy falls -6.2% - Talos Energy is down -6.2%, or -$1.15 to $17.50.

09:47 EDT Daqo New Energy falls -9.0% - Daqo New Energy is down -9.0%, or -$5.22 to $52.86.

09:47 EDT Sprinklr rises 13.6% - Sprinklr is up 13.6%, or $2.39 to $19.99.

09:47 EDT Arcus Biosciences rises 21.1% - Arcus Biosciences is up 21.1%, or $4.94 to $28.34.

09:45 EDT BuzzFeed to become publicly listed via merger 890 5th Avenue Partners - BuzzFeed announced that it will merge with 890 Fifth Avenue Partners (ENFA) to become a public company. 890 Fifth Avenue Partners Inc. has $288M in trust. The transaction includes an additional $150M in convertible note financing led by Redwood Capital Management and including CrossingBridge Advisors, Cohanzick Management, and Silver Rock Financial LP. The parent company will be known as BuzzFeed Inc. after the merger and listed on the public market under the ticker symbol "BZFD." BuzzFeed's management team will remain in place, with Jonah Peretti, BuzzFeed's Founder and CEO, and Felicia DellaFortuna, its CFO, continuing in their roles along with other executive team members. In addition, Adam Rothstein, Executive Chairman of 890 Fifth Avenue Partners Inc., and Greg Coleman, an advisor to 890 Fifth Avenue Partners Inc. and former BuzzFeed President, will join BuzzFeed's Board of Directors. Two additional board members will also be announced in the coming months bringing additional expertise and representation to the combined company. As part of the transaction, Peretti and Rothstein also announced an agreement with Hearst and Verizon (VZ) to acquire Complex Networks, a global youth entertainment company with massive reach through content and events spanning streetwear and style, food, music, sneakers, and sports. The $300M acquisition - made up of $200M in cash and $100M of equity in BuzzFeed - will be completed simultaneously with the closing of BuzzFeed's merger with 890 Fifth Avenue Partners Inc., and will immediately accelerate BuzzFeed's revenue growth through synergies and monetization opportunities, and solidify BuzzFeed's leadership as the preeminent youth digital media platform. The transaction has been approved by the boards of directors of both BuzzFeed and 890 Fifth Avenue Partners. The transaction is expected to close in the fourth quarter of 2021, subject to the satisfaction of customary closing conditions, including the approval of 890 Fifth Avenue Partners' stockholders. The transaction is expected to deliver approximately $288M of cash held in 890 Fifth Avenue Partners' trust account from its initial public offering in January 2021. The transaction is further supported by a $150M convertible note financing from institutional investors, led by Redwood Capital Management and including CrossingBridge Advisors, Cohanzick Management, and Silver Rock Financial LP.

09:39 EDT Google delays phase out of third-party cookies to end of 2023 - Google announced a timeline for Chrome's plan to phase out support for third-party cookies. "While there's considerable progress with this initiative, it's become clear that more time is needed across the ecosystem to get this right...Today, Chrome and others have offered more than 30 proposals, and four of those proposals are available in origin trials. For Chrome, specifically, our goal is to have the key technologies deployed by late 2022 for the developer community to start adopting them. Subject to our engagement with the United Kingdom's Competition and Markets Authority and in line with the commitments we have offered, Chrome could then phase out third-party cookies over a three month period, starting in mid-2023 and ending in late 2023...After this public development process, and subject to our engagement with the CMA, our plan for Chrome is to phase out support for third party cookies in two stages: Stage 1 (Starting late-2022): Once testing is complete and APIs are launched in Chrome, we will announce the start of stage 1. During stage 1, publishers and the advertising industry will have time to migrate their services. We expect this stage to last for nine months, and we will monitor adoption and feedback carefully before moving to stage 2. Stage 2 (Starting mid-2023): Chrome will phase out support for third-party cookies over a three month period finishing in late 2023." Reference Link

09:31 EDT Penn National jumps 3% to $79.10 after Q2 sales outlook tops estimates

09:24 EDT Carnival ends Q2 with $9.3B of cash and short-term investments - Carnival Corporation & plc CFO David Bernstein noted, "We ended the second quarter with $9.3 billion of cash and short-term investments. We believe we have sufficient liquidity to get us back to full operations and continue to be focused on pursuing refinancing opportunities to reduce interest rates and extend maturities. To date, through our refinancing efforts, we have reduced our future annual interest expense by over $120 million per year and expect to increase our near-term liquidity by $1.0 billion." CEO Donald added, "Once we return to full operations, our cash flow will be the primary driver of the company's return to investment grade credit over time, creating greater shareholder value."

09:22 EDT Carnival CEO says 'we continue to experience an acceleration in booking trends' - CEO Donald added, "Despite our minimal advertising spend, we continue to experience an acceleration in booking trends globally, including capturing significant latent demand for our new sailings this summer. This strong demand affirms confidence in our future. In addition, customer deposits grew this past quarter, a significant milestone on our path to resumption." Donald continued, "With the aggressive actions we have already taken to optimize our portfolio and reduce capacity, we believe we are well positioned to capitalize on pent up demand and to emerge a leaner more efficient company, reinforcing our global industry leading position." Booking volumes for all future cruises during the second quarter of 2021 were 45% higher than booking volumes during the first quarter of 2021. Cumulative advanced bookings for full year 2022 are ahead of a very strong 2019 as of May 31, 2021. The company highlights that this level of bookings was achieved with minimal advertising and marketing. (Due to the pause in guest cruise operations, the company's current booking trends will be compared to booking trends for 2019 sailings.) Total customer deposits as of May 31, 2021 and February 28, 2021 were $2.5B and $2.2B, respectively. During the quarter, customer deposits on new bookings exceeded the impact of refunds provided.

09:18 EDT Telus investing $2B to expand fiber optic network in Calgary - TELUS is investing $2B to connect more than 90 per cent of Calgary homes and businesses to our PureFibre network, Western Canada's largest and only 100 per cent pure fibre-to-the-home network. TELUS has already begun to connect some communities in Calgary to the PureFibre network, and anticipates the majority of homes and businesses will be connected by the end of 2023. TELUS is also launching PureFibre X, Canada's fastest Internet speed tier, with upload and download speeds of 2.5 Gbps, giving customers access to the world's fastest fibre Internet technology with the best upload and download speeds, and fastest home Wi-Fi connection. Calgarians will be the first to access PureFibre X, which TELUS will expand to PureFibre communities across Alberta and B.C. in the months ahead.

09:17 EDT Liquid Media CEO announces business solutions strategy for IP creators - Liquid Media Group released a letter to shareholders from CEO Ronald Thomson. The letter read, in part: "The start of 2021 has been extremely productive for Liquid. As the media and entertainment markets continue to evolve globally, we see incredible opportunities to scale our business and support creators to generate sustainable success...More simply put, we felt strongly that the time for small actions was over and that a big push for our business was required, the beginnings of which are evidenced by our recent announcements to acquire iNDIEFLIX, Filmocracy and iGEMS. Think about the businesses that have achieved success on a scale that contributes to the transformation of an industry; growth through acquisition and ownership of a closed-loop system is a common thread. This trend towards consolidation has left an increasing number of independent IP creators struggling to navigate the new landscape. Enter Liquid; as an end-to-end business solutions company, we will empower storytellers to package, finance, deliver and monetize their professional video IP globally, making it easier for creatives to take their professional content from inception through the entire process to monetization. This recalibration of Liquid's business is an optimization of our existing assets and operations in response to a massively underserved need...Liquid's new platform will leverage sophisticated artificial intelligence and big data analytics technology, informed process structuring, financial risk reduction and funding, production best practices, together with monetization expertise to ensure recoupment and profitability of IP across diverse distribution. This is accomplished both through existing assets and strategic partnerships, including the recently announced Insight TV and dotstudioPRO distribution agreements, bringing our network's total audience reach to nearly a billion households worldwide...As we leverage Liquid's existing assets, infrastructure and highly experienced team, our execution program in the coming months will also encompass several accretive acquisitions together with strategic partnerships, several of which have been announced as part of our solution engine's fourth stage - Monetization + Distribution. Healthy dialogue and negotiations are ongoing for additional opportunities across stages. These complementary initiatives will work to fulfill our end-to-end solutions value proposition for the filmed entertainment industry."

09:16 EDT QuantumScape to join Russell 3000 Index and Russell 1000 Index - QuantumScape announced that it is set to join the broad-market Russell 3000 Index and Russell 1000 Index at the end of the 2021 Russell indexes annual reconstitution, effective after the U.S. markets open on June 28.

09:14 EDT Document Security adds Ivy Brook Medical to its American Medical REIT portfolio - Document Security Systems announced its wholly owned DSS Securities subsidiary expanded its investment in American Medical REIT, or AMRE, through a $2.6M share purchase agreement. DSS Securities initially acquired 52% of AMRE in May 2020 and now owns 99% of the real estate investment trust. The additional investment in AMRE was used to fund the acquisition of Ivy Brook Medical Center, a 40,000 square foot first class, all medical facility. "While the pandemic has led to falling rents and rising vacancies in the commercial real estate markets, the health services segment is holding steady with landlords collecting rents at nearly 100% of pre-COVID levels," stated Frank D. Heuszel, CEO of DSS. "The percentage of American households with REIT stocks has nearly doubled, from 23%-44%, over the last two decades. AMRE is well positioned to capitalize on this trend, and we are excited to help facilitate this addition to its portfolio through our latest investment."

09:12 EDT Mondelez announces new food transparency program with Triscuit brand - Mondelez International announced a new food transparency program with the Triscuit brand. "Now, consumers can discover the journey of the white-winter wheat baked into some of their Triscuit crackers from a coop of farmers' fields in the thumb of Michigan to where the product is made. This data-driven, consumer-centric supply chain transparency pilot is the first of its kind for Mondelez International in North America," the company said. "We are committed to understanding and meeting the growing needs and preferences of our consumers, and those needs are evolving to a more holistic sense of well-being and value-oriented purchase decisions. Consumers are demanding more transparency about their food, and are keen to have access to information about where their food comes from and how it is grown," said Jay Cooper, President, North America Biscuits, Mondelez International. Mondelez International recently piloted a similar project in France, using blockchain technology to allow LU biscuit consumers to trace the journey of Harmony wheat from the field to shelf. Both programs were created in partnership with Connecting Food, a supply chain transparency platform powered by blockchain, to provide third-party traceability advisement and technology services.

09:09 EDT Shift adds Jason Curtis as Chief Accounting Officer - Shift announced the appointment of Jason Curtis as Chief Accounting Officer. In this newly created role, Curtis will be responsible for all accounting and SEC reporting functions. Most recently, he served as CFO of Boscov's. Curtis's appointment was effective June 1, 2021.

09:08 EDT Gevo announces Tony Wells joins as Site Leader for Net-Zero 1 facility - Gevo, announced that Tony Wells has joined Gevo as its General Manager/Site Leader for its future Net-Zero 1 facility expected to be located in Lake Preston, South Dakota. Wells brings 30+ years of operations management, engineering, and business development experience across industries including corn milling, food processing, ethanol and biodiesel production. He is expected to lead and assemble the organization that will operate the Net-Zero 1 facility.

09:07 EDT Upland Software acquires Panviva for $19.8M - Upland Software announced that it has acquired Panviva, a cloud-based enterprise knowledge management solution. Panviva provides businesses the ability to orchestrate knowledge into a single source of truth and to audit what is consumed and where. The purchase price paid for Panviva was $19.8M in cash at closing, paid out of cash on hand, and a $3.5M cash holdback payable in twelve months. Upland expects the acquisition to generate annual revenue of approximately $7.5M, all of which is recurring, and will be subject to reductions for deferred revenue discount as a result of GAAP purchase accounting, estimated at $2M for the remainder of 2021. The price paid for the acquisition is within Upland's target range of 5-8x pro forma adjusted EBITDA and it is expected that Panviva will generate at least $3.4M in adjusted EBITDA annually once fully integrated.

09:07 EDT Evolus announce article on safety of jeuveau in patients with Skin of Color - Evolus announced a peer reviewed journal article was published in Dermatologic Surgery highlighting the efficacy and safety of prabotulinumtoxinA for the treatment of moderate to severe glabellar lines, also known as frown lines between the eyes, in adult patients with Skin of Color, or SOC. The article focuses on pooled data from 492 Jeuveau-treated patients who participated in two US multicenter, randomized, double-blind, placebo-controlled, single-dose phase III clinical studies. These patients were given a single dose of 20 units of Jeuveau and outcomes were compared between those with and without SOC, as defined by Fitzpatrick skin Types IV + V + VI and I +II + III, respectively. Outcomes were also compared between race-based subsets of each population: those with SOC who self-identified as Black/African American and those without SOC who self-identified as White. Responder rates among patients with SOC were lower than those without SOC, by 5.9% on average across all visits. At Day 30, responder rates were 94.0% and 96.0%, respectively. At no time point were differences statistically significant. Headache was the most common treatment related adverse event, occurring in 12.1% and 8.2% of patients with and without SOC, respectively. Jeuveau is marketed in the United States by Evolus. The product is marketed by a partner in Canada as Nuceiva with European launch planned for early 2022.

09:05 EDT Wendy's and Global Investors partner to expand in Central Asia region - Wendy's and Global Investors announced three strategic development agreements to expand Wendy's brand presence in the Central Asia Region over the next nine years. These partners will help in bringing Wendy's presence to a total of 65 restaurants across Georgia, Uzbekistan and Kazakhstan by 2030. To initiate the development plans, Kusto Group and Wissol Group opened the first two Wendy's restaurants in Kazakhstan in Almaty earlier this year, along with opening a new drive-thru only restaurant in Tbilisi, Georgia.

09:03 EDT Virtu Financial joins Pyth Network as newest partner - Virtu Financial announced that it has joined the Pyth Network, a decentralized financial market data distribution platform. Virtu will contribute its financial market data across equities, FX, futures, and cryptocurrencies for consumption by smart contracts using the Solana blockchain and other major blockchains. Douglas Cifu, CEO of Virtu Financial said, "We are excited to join this promising network that we hope will transform the way pricing market data is used on the blockchain. With growing support from the trading community, we believe the Pyth Network will become an integral piece of infrastructure in the quickly evolving DeFi ecosystem, enabling new market participants and more efficient markets."

09:02 EDT Synopsys initiates $175M accelerated share repurchase agreement - Synopsys has entered into an accelerated share repurchase agreement with Mizuho Markets Americas to repurchase an aggregate of $175M of Synopsys stock. Synopsys will receive an aggregate initial share delivery of approximately 521,000 shares, with the remainder, if any, to be settled on or before August 18, upon completion of the repurchases.

09:01 EDT Hims & Hers to acquire dermatology specialist Apostrophe, terms undisclosed - Hims & Hers Health announced its intentions to acquire teledermatology specialist, Apostrophe, as part of the Company's ongoing excellence-based category expansion. Financial details of the transaction will not be disclosed at this time. "Personalized dermatology has become increasingly of interest to our consumers," said Andrew Dudum, CEO and co-founder of Hims & Hers. "In the seven years since its founding, Apostrophe has built a brand that, like Hims & Hers, has attracted and heavily engaged GenZ and Millennial consumers. With this investment, we will accelerate our dermatology business, offering highly personalized dermatology treatments at scale. We are excited to welcome the Apostrophe team to the Hims & Hers family." Apostrophe has created a clinical platform that powers bespoke treatment plans that include some of the most sophisticated, personalized combinations of topical formulas and oral medications fulfilled by the affiliated Apostrophe pharmacy, which is currently licensed to fulfill orders in 29 states. This compounding infrastructure, combined with their best-in-class dermatology capabilities, will expand Hims & Hers' ability to provide consumers with some of the most advanced and personalized dermatology treatments, faster and at scale. The deal is expected to close during the third fiscal quarter of this year.

08:57 EDT Diginex: EQONEX exchange exceeds $5B in 30 day volume - Diginex Limited, recently rebranded as EQONEX Group, announced that total spot and derivative trading volumes on EQONEX, its cryptocurrency exchange, exceeded $5B over the past 30 days. Volumes in June have continued their recent strong upward trajectory, with average daily volumes in June month-to-date of $190M, representing an increase of 206% and 80% from April and May this year, respectively. Compared to the first quarter of 2021 and prior to the launch of its native exchange token EQO, volumes in June month-to-date are up over 12 times.

08:44 EDT Assure Holdings supports auditory brainstem implant surgery - Assure Holdings announced that it supported an auditory brainstem implant surgery. The procedure was performed by Moises Arriaga, MD, a Louisiana based neurotologist, and Assure neurophysiologists utilizing intraoperative neuromonitoring equipment from Cadwell Industries, a provider of neurodiagnostic solutions. The auditory brainstem implant surgery was performed to restore hearing in a patient who had lost this function. The procedure is rare and required a tightly integrated surgical team, including an Assure neurophysiologist using Cadwell Cascade Surgical Studio, to support Dr. Arriaga as he identified and mapped the lateral recess of the fourth ventricle, confirming the cochlear nucleus to pinpoint the optimal placement for the implanted stimulating device. In addition, neurophysiologists monitored all associated lower cranial nerves, minimizing the potential negative side effects of the implant.

08:43 EDT Staffing 360 Solutions announces $10M PPP loan forgiveness - As recently reported, the Company received notification from the Small Business Administration of the full forgiveness of the $10M PPP loan made to Monroe Staffing Services, LLC, an indirect wholly owned subsidiary of the Company. The Company has applied for forgiveness of a further $9.4M of PPP loans. While there is no guarantee of forgiveness, the Company is optimistic that these remaining PPP loans will be similarly forgiven.

08:41 EDT Ageagle Aerial Systems expands HempOverview licensing agreement with Florida - AgEagle Aerial Systems announced the Florida Department of Agriculture and Consumer Services, or FDACS, has expanded its licensing of AgEagle's HempOverview Software-as-a-Service platform, providing access to the platform's full suite of technology-enabled capabilities. In November 2019, FDACS originally licensed HempOverview's registration module to manage its online application submission and registration process for hemp growers and their farms and hemp fields for the 2020, 2021 and 2022 planting seasons. The recent licensing expansion allows FDACS to use all of HempOverview's software platform. FDACS has also tasked AgEagle with developing a custom registration software platform to enhance communications, licensing and general compliance relating to the oversight and protection of more than 500 endangered and commercially exploited wild plants native to Florida.

08:39 EDT Five Below expands partnership with Instacart nationally - Five Below announced that it will bring the convenience of same-day delivery to even more of its customers as part of the company's partnership with Instacart. The expansion of same-day delivery comes after Five Below's initial pilot launch with Instacart in December of 2020, and will give thousands of potential customers the ability to have their Five Below purchases delivered right to their door with service now available at 1,100 store locations. "When we first partnered with Instacart this past December, we knew the convenience of the platform's same-day delivery and curbside pickup options would be a game-changer for our customers amid an unprecedented holiday season," said Felipe Zardo, Senior Vice President of Digital for Five Below. "After witnessing the overwhelming response in the markets in which we first launched this service, we knew we needed to bring Instacart delivery to even more people, which is why we are so excited to be rolling this out in more than 700 new locations." Five Below and Instacart initially launched their partnership at select stores in Baltimore, Buffalo, Chicago, Cleveland, and Detroit, as well as locations in Florida, California and Texas.

08:38 EDT Sellas Life Sciences reports updated data from mesothelioma study of GPS - SELLAS Life Sciences Group announced updated clinical data from a Phase 1 investigator-sponsored clinical trial of its lead clinical candidate, galinpepimut-S, combined with the checkpoint inhibitor nivolumab in patients with macroscopic deposits of malignant pleural mesothelioma. The study details are as follows: Four evaluable male patients, aged approximately 67.3 + 4.1, received GPS plus nivolumab for at least one month. Initial tumor stages were II, IIB and IV. All patients had the MPM epithelioid and/or sarcomatoid variant, a tumor which is universally expressing Wilms Tumor 1, one of the most widely expressed cancer antigens, ranked by the National Cancer Institute as the top priority among cancer antigens for immunotherapy. Patients have received and progressed with, or are refractory to, frontline pemetrexed-based chemotherapy. Average overall survival was 35.3 + 24.0 weeks with a median OS of 35.4 weeks, while average progression-free survival was 8.8 + 4.2 weeks with a median PFS of seven weeks, both at a median follow-up of 35.4 weeks. The safety profile of the GPS-nivolumab combination was similar to that seen with nivolumab alone, with the addition of only low-grade, temporary local reactions at the GPS injection site, consistent with previously performed clinical studies with GPS. With approximately 3,300 cases in the United States each year, accompanied by a rising incidence in developing countries, MPM is notoriously difficult to treat and can lead to poor clinical outcomes with respect to both overall survival and progression-free survival, especially for those patients with the sarcomatoid variant who show a median overall survival of approximately 4.0 to 5.0 months. In relapsed and refractory patients who progressed after the first line standard of care pemetrexed, a similar patient population to that in the GPS nivolumab combination trial, the common treatment regimen is vinorelbine and overall survival in those patients is reported to be between 4.5 and 6.2 months. In patients treated with other chemotherapy regimens, such as carboplatin and irinotecan, median overall survival is reported to be approximately 7.0 months. SELLAS expects to report additional clinical and immune response data in Q4 2021, including an assessment of CD8+ and CD4+ T-cell responses to the WT1 peptide pool in the GPS mixture, as well as epitope spreading by testing for antibody presence directed specifically against the full-length WT1 protein and IgG's presence against other key oncofetal antigens expressed in MPM.

08:37 EDT Castor Maritime announces new charter agreement, delivery of M/T Wonder Formosa - Castor Maritime announces that the M/V Magic Argo, a 2009 built Kamsarmax dry bulk carrier, following completion of its previous employment contract, has been fixed on a time charter contract earning a daily gross charter rate of $33,000, which commenced on June 23, 2021, with a term of about 100 days. The company also announces that on June 22, 2021, it took delivery of the M/T Wonder Formosa, the 2006 Korean-built MR1 tanker it had agreed to acquire as previously announced on April 30, 2021. The M/T Wonder Formosa has been entered into Scorpio's Handy Plus Pool, specializing in the employment of MR1 tanker vessels. The M/T Wonder Formosa acquisition was financed in its entirety with cash on hand.

08:37 EDT Vinco Ventures announces 'spin out' of Emmersive Entertainment Vinco Ventures - Vinco Ventures announced the planned 'spin out' of Emmersive Entertainment as its own standalone publicly traded entity. The transaction is contemplated to occur during Q3. The resulting Emmersive Entertainment Public Company will be led by current Vinco Ventures Chief Strategy Officer Brian McFadden. The company plans to conduct this transaction in Q3 and will shortly announce the Shareholder of Record Effective date, providing all Vinco Venture Shareholders, as of the Record Effective date, an equity position in the resulting company. Additionally, the companies will continue their originally planned partnership allowing them to leverage the traffic and technologies that they currently possess.

08:36 EDT Cellectar Biosciences announce election of Dr. Chanan-Khan to board of directors - Cellectar Biosciences announced that Dr. Asher Alban Chanan-Khan has been elected to its board of directors as an independent director. Dr. Chanan-Khan currently serves as Professor of Medicine & Oncology at the Mayo Clinic School of Medicine, a position he has held since 2011.

08:35 EDT Kura Oncology doses first patient in Phase 1b portion of KOMET-001 trial - Kura Oncology announced that the first patient has been dosed in the Phase 1b portion of KOMET-001, a Phase 1/2 clinical trial of the company's oral, potent and selective menin inhibitor, KO-539, in patients with relapsed or refractory acute myeloid leukemia. The Phase 1b portion of the study is designed to determine the lowest dose of KO-539 that provides maximum biologic and clinical effect in two expansion cohorts each with NPM1-mutant and KMT2A-rearranged relapsed/refractory AML patients. Both doses have demonstrated preliminary evidence of biologic and clinical activity and were determined to be safe and well tolerated in the Phase 1a portion of the study. Kura expects to enroll at least 12 patients in each of the Phase 1b expansion cohorts and assess those patients for safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy in order to determine the recommended Phase 2 dose. In addition, the Phase 1b gives the company flexibility to enroll up to 18 additional patients per cohort, as appropriate. Kura believes that data from patients enrolled in the cohort selected as the recommended Phase 2 dose can be included as part of the registration-directed portion of the KOMET-001 trial.

08:34 EDT Aeglea BioTherapeutics begins dosing in Phase 1/2 trial of AGLE-177 - Aeglea BioTherapeutics dosed the first patient in its first-in-human Phase 1/2 clinical trial investigating AGLE-177 for the treatment of Homocystinuria. AGLE-177 is a novel engineered human enzyme therapy designed to lower the total level of homocysteine in the plasma. Aeglea anticipates providing a clinical update on the program prior to the end of 2021. Cystathionine beta synthase deficiency, also known as Classical Homocystinuria, is an inherited disorder of methionine metabolism that results in elevated homocysteine and homocystine in the plasma and urine. Disease management strategies are challenging, have poor adherence and many patients are not responsive to treatment. It is estimated that there are more than 30,000 people living with Homocystinuria in the global addressable markets. The multicenter, open label, dose escalation Phase 1/2 trial is anticipated to enroll 16-20 patients diagnosed with Homocystinuria aged 12 years or older at sites located in the U.K. and Australia. The primary endpoint is the safety and tolerability of AGLE-177. Secondary endpoints include pharmacokinetic assessments as well as reduction in plasma total homocysteine levels.

08:34 EDT GreenSky announces Ritesh Gupta as COO - GreenSky, announced that Ritesh Gupta has been named Executive Vice President and Chief Operating Officer. Mr. Gupta who joined GreenSky as Executive Vice President of Operations will transition into the newly created executive role effective July . "I am very excited for Ritesh to take on the expanded role of leading GreenSky's operations and driving enterprise initiatives cross-functionally to accelerate achievement of our business objectives," said David Zalik, Chief Executive Officer. "As a member of GreenSky's executive management team, Ritesh has brought a wealth of experience and leadership to the company and played a critical role in successfully navigating this past year's challenging environment related to the pandemic while also helping develop new growth initiatives. I am encouraged and excited by the strength and depth of GreenSky's leadership team, who I know are well poised to continuing to lead our company in achieving our future goals."

08:33 EDT SG Blocks subsidiary acquires development parcel in Atlanta with partnership - SG Blocks announced that SGB Development, a wholly-owned subsidiary of the company, through its partnership with CMC Development, ZT Architecture + Land Development and Community Development Consortium, has acquired a six-acre site on Norman Berry Drive in Atlanta, Georgia for the development of a rental apartment community.

08:28 EDT Aleafia Health expands edibles portfolio with Salted Caramel Pretzel Bites - Aleafia Health announced the expansion of its cannabis edibles portfolio with Salted Caramel Pretzel Bites. The new format is now available and sold under the Company's cannabis edibles brand Bogart's Kitchen, joining the previously released THC and CBD Soft Chews. Each pretzel bite features a pair of pretzels sandwiching a cannabis-infused caramel. There are two pretzel bites per package, each containing five mg of THC. The format is designed and produced in the commercial kitchens of Aleafia Health's product innovation centre in Paris, Ont.

08:26 EDT Novan announces inclusion in Russell Microcap Index - Novan announced that as part of the annual reconstitution of the Russell stock indexes, Novan has been selected to join the Russell Microcap Index, effective after the U.S. market close on June 25, 2021, according to the list of additions published by FTSE Russell as of June 4, 2021.

08:23 EDT Biomerica signs exclusive distribution agreement in Canada for hp+detect test - Biomerica announced that it has signed an exclusive five-year distribution agreement with a Canadian partner for the distribution and marketing of Biomerica's new and proprietary Helicobacter pylori test, called hp+detect. The hp+detect product has been developed for the identification and monitoring of H. pylori infection, the leading cause of duodenal and gastric ulcers, and a contributing risk factor associated with gastric cancer. In order to sell the product in Canada, Biomerica's distribution partner will now seek Health Canada clearance using the clinical data recently generated by Biomerica using the hp+detect product. The company also intends to seek a CE Mark for the product to be sold in the European Union and FDA clearance in the USA. "H. pylori infection can cause serious health conditions, so early detection of the disease in symptomatic patients is important for those infected with these bacteria. Our hp+detect product identifies the presence of H. pylori antigen, enabling doctors to diagnose patients, as well as monitor treatment efficacy," said Zack Irani, Chairman and Chief Executive Officer of Biomerica. "We're pleased to enter into this relationship with a well-established medical distributor in Canada. This partnership will be our first step to launching the hp+detect test in markets around the world to assist gastroenterologists and other medical professionals who are dedicated to preventing ulcers and gastric cancer in the patients they treat."

08:21 EDT Osisko Development reports drilling results from Cariboo Gold Project - Osisko Development is pleased to announce further drilling results from the 200,000-meter 2021 exploration and category conversion drill program campaign at its Cariboo Gold Project in central British Columbia. A total of ten diamond drill rigs are currently on the Project. A total of 68 holes and 30,000 drilled meters thus far in 2021 at Valley Zone, located between the Shaft and Cow deposits. Recent assay results include holes CM-21-001 to CM-21-016 (Figure 1CM-21-005 intersected a modelled vein corridor that assayed 17.16 g/t Au over 10.7 meters, increasing confidence in the existing model. Drillhole CM-21-012 intersected 10 mineralized vein corridors at least 3 meters wide extending vein corridors down to vertical depths of 440 meters and additional high-grade samples including 150 g/t Au over 0.50 meters, 62.6 g/t Au over 0.50 meter and 52.9 g/t Au over 0.50 meter. Recent Drilling Highlights: 11.39 g/t Au over 4.35 meters in CM-21-002 including 93.60 g/t Au over 0.50 meter; 15.01 g/t Au over 5.10 meters in CM-21-004 including 80.20 g/t Au over 0.85 meter; 124.00 g/t Au over 0.65 meter in CM-21-004; 11.54 g/t Au over 3.45 meters in CM-21-005 including 34.70 g/t Au over 1.00 meter; 17.16 g/t Au over 10.70 meters in CM-21-005 including 80.00 g/t Au over 1.20 meters; 7.86 g/t Au over 5.75 meters in CM-21-008 including 53.00 g/t Au over 0.80 meter; 4.99 g/t Au over 9.65 meters in CM-21-008l; 5.83 g/t Au over 15.15 meters in CM-21-008; 75.30 g/t Au over 0.85 meter in CM-21-010; 55.30 g/t Au over 0.50 meter in CM-21-012; 11.15 g/t Au over 5.50 meters in CM-21-012 including 38.50 g/t Au over 0.70 meter; 73.32 g/t Au over 1.25 meters in CM-21-012 including 150.00 g/t Au over 0.60 meter in CM-21-012; 13.35 g/t Au over 3.60 meters in CM-21-012; 7.54 g/t Au over 5.40 meters in CM-21-012; 62.60 g/t Au over 0.50 meter in CM-21-012; 52.90 g/t Au over 0.50 meter in CM-21-012; 5.62 g/t Au over 6.45 meters in CM-21-012; 4.49 g/t Au over 12.00 meters in CM-21-013; 6.81 g/t Au over 10.30 meters in CM-21-013; 3.25 g/t Au over 16.35 meters in CM-21-015. Mineralized quartz veins on Cariboo are overall sub-vertical dip and northeast strike. Vein corridors are defined as a high-density network of mineralized quartz veins within the axis of the last folding events and hosted within a brittle meta-sandstone or calcareous meta-sandstone. Vein corridors are modelled at a minimum thickness of 2.0 meters and average about 4.5 meters true width. Individual mineralized veins within these corridors have widths varying from centimeters to several meters and strike lengths from a few meters to over 50 meters. These corridors have been defined from surface to a vertical depth averaging 300 meters and remain open for expansion at depth and along strike. Gold grades are intimately associated with quartz vein-hosted pyrite as well as pyritic, intensely silicified wall rock haloes in close proximity to the veins. True widths are estimated to be 60% to 75% of reported core length intervals. Intervals not recovered by drilling were assigned zero grade. Top cuts have not been applied to high grade assays. The Corporation is pleased to announce that incentive stock options have been granted to officers to purchase 492,600 common shares at a price of $7.10 for five years with vesting terms of; one third on June 23rd 2022, one third on June 23rd 2023 and one third on June 23rd 2024. These options have been granted in accordance with the Corporation's Stock Option Plan. The Company has also granted an aggregate total of 427,100 restricted share units to officers in accordance with the RSU Plan of the Company. All RSUs will vest on June 23rd 2024.

08:18 EDT Selecta Biosciences appoints Nishan de Silva to board of directors - Selecta Biosciences announced the appointment of Nishan de Silva, M.D. to its Board of Directors. Dr. de Silva will provide strategic guidance and operational insights as Selecta continues to advance its clinical pipeline. Dr. de Silva is currently Chief Executive Officer and Director of AFYX Therapeutics.

08:17 EDT Rogers announces University of Waterloo launches autonomous 5G shuttle - The University of Waterloo is showcasing the operation of a driverless, autonomous shuttle research program that will transport students and staff around campus. The demonstration of the shuttle, dubbed "WATonoBus" by the research team, is the first of its kind at a Canadian academic institution and marks a significant milestone in a multi-year initiative to demonstrate and integrate autonomous transportation onto the campus. This milestone features another significant technological advancement, as the shuttle becomes the first in the country to operate remotely over Rogers 5G network, thanks to a Rogers partnership agreement with the University to advance 5G research in the Toronto-Waterloo tech-corridor.

08:16 EDT Heico acquired 80.1% of the operating assets of Camtronics - HEICO announced that its Flight Support Group has acquired 80.1% of the operating assets of Camtronics for cash at closing. Additional financial details were not disclosed. HEICO expects the acquisition to be accretive to its earnings within the first year following closing. Including Camtronics, HEICO has completed acquisitions of six niche, highly specialized businesses since the start of the COVID-19 pandemic. Tulsa, OK-based Camtronics is an FAA Part 145 repair station with extensive proprietary FAA-DER repairs. The company serves a variety of domestic and international commercial and cargo airlines. Camtronics was founded in 1999 by David Campbell and his son Rick Campbell. The Campbell family is retaining ownership in the business. David Campbell will remain with the business as Vice President and General Manager.

08:14 EDT Nuwellis reports inducement grants under Nasdaq listing rule - Nuwellis announced that, effective June 22, 2021, the independent directors approved four equity awards under Nuwellis' 2021 Inducement Plan, as material inducement to four individuals entering into employment with the company. The equity awards were approved in accordance with NASDAQ Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan. In connection with entering into employment with Nuwellis, Inc., the individuals, who were not previously employees or directors of Nuwellis, received options to purchase an aggregate of 46,737 shares of the Company's common stock. The option awards have an exercise price of $3.98 per share, the closing price of Nuwellis' common stock on June 22, 2021, the date of the grant. The options have a ten-year term and vest over a period of four years, with 25% vesting one year after the date of grant and the remaining 75% vesting in 36 approximately equal monthly increments, provided the new hire's employment is continuing on each such date, and subject to acceleration or forfeiture upon the occurrence of certain events as set forth in the new hire's option agreement.

08:13 EDT Skylight Health acquires Doctors Center, terms not disclosed - Skylight Health Group announced that the Company has acquired the Doctors Center Inc., a primary care group with four locations in Jacksonville, Florida. Adds four clinical locations to bring Skylight's primary care network to over 23 locations across 5 States; Expands patient count by 6 thousand lives with opportunities for value-based care programs; Strategic acquisition builds further density of patient and providers in Northeast Florida; and 2020 unaudited revenues of approximately C$3.2M and expected EBITDA margin of 10%. Doctors Center has been providing primary care services to patients in Jacksonville for 30 years. The practice which consists of 6,000 patients and 5 providers, operates 4 locations across Jacksonville. The practice contracts under a fee-for-service model with payors and health plans. Under the Skylight Health platform, both teams will work together to bring improved services to patients and support to providers under improved and aligned contracts with health payors including Medicare and Medicaid. Skylight will look to grow the number of lives under managed care through the deployment of its proprietary management platform, technology enabled tools and operational and clinical leadership teams.

08:10 EDT Foothills Exploration eliminates over $1.6M of convertible debt - Foothills Exploration announced that the Company has reached settlement agreements with and/or repaid and retired convertible promissory notes with all but one of its variable-rate convertible noteholders. Balance Sheet Initiatives: For the remainder of 2021, the Company's intended strategy is to settle and eliminate its outstanding variable rate convertible debt to clean up its balance sheet and better position itself for future growth. To that end, the Company has reached settlement and mutual release agreements with and/or repaid and retired convertible promissory notes with all but one of its variable-rate convertible noteholders. Over the past 100 days, the Company has paid $1.6 million to retire 10 variable-rate convertible promissory notes.

08:10 EDT COMSovereign Holding, Radisys partner in 5G computing technology - COMSovereign Holding and Radisys, a provider of open telecom solutions, announced a strategic technology partnership that will focus on enhancing COMSovereign's O-RAN-compliant 5G solution with the SAGUNA Multi-access Edge Cloud and Radisys' Connect 5G RAN software portfolio to address private 5G and edge computing deployments and use cases. Together, COMSovereign and Radisys will seek to accelerate the deployment of 5G networks in Defense, Public Safety, and Commercial markets by reducing time-to-market and the large CAPEX typically required for 5G networks. Radisys will play a role in enabling the integration and commercialization of COMSovereign's 5G RAN, Core, and MEC-based products and solutions for a range of applications including autonomous vehicles, virtual reality, smart cities and power grids, automated manufacturing and robotics, and remote/telemedicine.

08:08 EDT Corbus says DETERMINE Phase 3 study did not meet primary endpoint - Corbus Pharmaceuticals announced topline results from the Phase 3 DETERMINE study of lenabasum in adults with the rare, heterogeneous, autoimmune disease dermatomyositis. Primary endpoint: The study did not meet its primary endpoint of Total Improvement Score at Week 28. Higher TIS values indicate greater overall improvement. At Week 28, the lenabasum 20 mg twice daily group achieved a mean TIS of 28.3 versus the control group mean TIS of 26.7, p = 0.1965. All subjects, including the control group, received standard background treatments, with 89% of dosed subjects receiving greater than or equal to 1 immunosuppressive or immunomodulating therapy. Additional pre-specified analyses of the overall effect on TIS of lenabasum 20 mg twice daily versus control group through Week 52 showed a trend of beneficial effect of lenabasum, nominal p = 0.0795. Additional findings: Dermatomyositis patients have characteristic muscle weakness and inflammatory skin involvement. This study enrolled subjects with the two major types of dermatomyositis: classic dermatomyositis with both muscle weakness and skin involvement and dermatomyositis with no significant muscle weakness but with skin involvement. Improvement in muscle weakness is heavily weighted in the TIS score. In the overall study, higher TIS scores were seen in those subjects who had muscle weakness and were treated with lenabasum 20 mg twice daily versus the control group, nominal p = 0.0302. Conversely, the Cutaneous Dermatomyositis Activity and Severity Index activity score, a secondary endpoint in this study, is a validated outcome that was designed to assess inflammatory skin involvement in dermatomyositis. In the overall study, greater improvement in CDASI activity scores was seen in subjects with skin involvement but no muscle weakness who were treated lenabasum 20 mg twice daily versus the control group, nominal p = 0.0166. This is a similar patient population and the same endpoint as was tested in Corbus' previously completed Phase 2 study. Effect of lenabasum on lung function was a secondary endpoint in this study, and no statistically significant difference was seen at Week 28 in the lenabasum 20 mg twice daily group versus control group. In the overall study, other pre-specified analyses showed that subjects on stable immunosuppressive therapies had an improvement in forced vital capacity compared to the control group, nominal p = 0.0591. Efficacy results for the lenabasum 5 mg twice daily group were generally similar to those for the control group. Safety data showed 86.5% of lenabasum-treated subjects and 85.9% of control subjects had treatment-emergent adverse events, 11.5% of lenabasum-treated subjects and 5.6% of control subjects had serious AEs, and no lenabasum-treated subject and 1 control subject discontinued study drug because of an AE related to study drug. Adverse events that occurred in greater than or equal to 10% lenabasum-treated subjects and also in greater than or equal to 5% more lenabasum-treated subjects than control subjects were diarrhea, dizziness, and nausea. There were fewer AEs of dermatomyositis worsening in the lenabasum 20 mg twice daily group than the control group.

08:07 EDT Pieris Pharmaceuticals receives orphan drug designation for cinrebafusp alfa - Pieris Pharmaceuticals announced that the FDA has granted orphan drug designation to cinrebafusp alfa, a 4-1BB/HER2 bispecific, for the treatment of HER2-high and HER2-low expressing gastric cancers.

08:06 EDT PTC Therapeutics' Emflaza in DMD shows physical function improvement - PTC Therapeutics presented pooled placebo data from studies in which results confirmed the clinical benefit of Emflaza over prednisone for the treatment of Duchenne muscular dystrophy, or DMD. The results, presented at the 2021 Parent Project Muscular Dystrophy Annual Conference, demonstrated that DMD patients on daily Emflaza performed better on key measures of physical function than patients taking daily prednisone. PTC also presented oral and poster presentations reporting long-term, real-world and clinical data, including its role in slowing DMD disease progression and improving ambulatory function over time. Also highlighted were results from a real-world study of patients who switched from prednisone to Emflaza following the FDA approval.

08:06 EDT Longeveron announces abstract on data of Phase 1 trial of Lomecel-B infusion - Longeveron announced that an abstract summarizing the results of its Phase 1 trial of Lomecel-B infusion for patients with mild Alzheimer's disease has been accepted for a Developing Topics poster presentation at the 2021 Annual Alzheimer's Association International Conference, being held July 26-30, 2021 in Denver, CO and online. The abstract is titled "Safety and Efficacy of Lomecel-B in Patients with Mild Alzheimer's Disease: Results of a Double-Blinded, Randomized, Placebo-Controlled, Phase 1 Clinical Trial." This 33 subject study was supported by two competitive Part the Cloud Challenge on Neuroinflammation grants from the Alzheimer's Association. "We are extremely pleased that the Alzheimer's Association has recognized our trial and data by giving us this opportunity to present the findings in poster presentation form at the prestigious AAIC," said Dan Gincel, Ph.D., Senior Vice President of Strategic Collaborations & Scientific Affairs at Longeveron. "The trial met its primary endpoint of demonstrating safety and feasibility, and importantly, no Alzheimer's Related Imaging Abnormalities, after infusion with Lomecel-B. Furthermore, we were thrilled to observe that treatment with low-dose Lomecel-B slowed cognitive decline compared to the placebo group as measured by the Mini Mental State Exam score. As a result, we look forward to advancing Lomecel-B into a Phase 2 clinical trial in the second half of 2021."

08:04 EDT Kratos Defense awarded $8.6M task order to complete 50shp class turbine engine - Kratos Defense & Security Solutions announced that Kratos Turbine Technologies Division has been awarded an $8.6M task order under its Advanced Turbine Technologies for Affordable Mission ID/IQ contract. The program will be managed by the Turbine Engine Division of the Air Force Research Laboratory. Under the contract KTT will complete the design, build, assemble and test of an affordable turboshaft engine for Group 3 UAVs. The engine design is convertible to produce the electrical power required of advanced hybrid electric aircraft. The award follows the successful completion of multiple programs where KTT completed concept and engine trade studies for Group 3 UAVs with the guided leadership of AFRL/RQT. The objective of the awarded task order is to complete the engine development for flight testing and to demonstrate the high-power-to-weight, high-efficiency, and increased durability of the recuperated engine design. Work will be performed by KTT in Florida.

08:04 EDT CSX and Wabtec partner to drive sustainable transportation solutions - CSX (CSX) and Wabtec (WAB) are partnering to accelerate sustainable rail by modernizing locomotives across CSX's fleet and implementing advanced digital technologies to deliver significant fuel efficiency and emissions reductions for CSX's rail operations. The partnership will help CSX in their commitment to reduce greenhouse gas emissions intensity by 37 percent by 2030. "We are excited to partner with Wabtec on advanced solutions that will transform our fleet while improving our carbon footprint," said Jamie Boychuk, CSX executive vice-president of operations. "By modernizing our fleet and implementing the new Trip Optimizer Zero-to-Zero, Wabtec's sustainable technologies will help CSX achieve our climate goals."

08:03 EDT Iridium awarded $30M R&D U.S. Army contract - Iridium has been awarded a research and development contract worth up to $30M by the U.S. Army to develop a payload to be hosted on small satellites that supports navigation systems, guidance and control for the global positioning system and GPS-denied precision systems. The new experimental Iridium payload is intended to be hosted by another Low Earth Orbit commercial satellite constellation, complementing the Iridium constellation's capabilities. The development of this new payload is based on Iridium Burst technology, a service that can transmit data to millions of enabled devices at a time from space.

08:02 EDT Aquestive Therapeutics resubmits new drug application for Libervant - Aquestive Therapeutics announced the resubmission of its New Drug Application to the U.S. Food and Drug Administration for Libervant Buccal Film for the management of seizure clusters in response to the September 25, 2020 Complete Response Letter from the FDA. The submission included additional statistical modeling and supporting analyses of the existing clinical data based upon the guidance received from the Agency. "As we have committed in previous statements regarding the filing of our NDA for Libervant, yesterday we resubmitted the NDA. The resubmission for Libervant marks a significant milestone for Aquestive. We believe that the resubmission addresses all of the issues raised in the CRL based upon the guidance we received from the FDA," remarked Keith Kendall, CEO of Aquestive. "We look forward to continuing our dialogue with the FDA during the review period as we remain focused on bringing our non-invasive and innovative product to the underserved population of patients with refractory epilepsy." Aquestive received a CRL from the FDA in September 2020, completed a Type A meeting with the FDA in November 2020 and received further guidance from the FDA in February 2021. The company anticipates a six-month review process and expects to receive a PDUFA goal date in late 2021.

08:00 EDT Corbus Pharmaceuticals trading halted, news pending

07:50 EDT TD Bank Group names Kelvin Tran as CFO - Kelvin Tran, Executive Vice President, Enterprise Finance, will become CFO of TD Bank Group and join the Bank's Senior Executive Team, reporting to Masrani. Tran has been with TD for more than 20 years. He has served as CFO of TD Bank, America's Most Convenient Bank, TD Bank Group Chief Auditor and Chief Accountant, CFO of TD Securities, and SVP of Treasury and Balance Sheet Management. Riaz Ahmed, Group Head and CFO of TD Bank Group, will become Group Head, Wholesale Banking and President and CEO of TD Securities, reporting to Masrani.

07:48 EDT Jacobs wins new Air Force B-21 aircraft five-year contract - Jacobs was awarded a new U.S. Army Corps of Engineers Kansas City District Architecture and Engineering contract to support the planning, design and construction of facilities and infrastructure in service of the Air Force's B-21 mission. The Multiple Award Task Order Contract supports AE requirements primarily at Ellsworth Air Force Base, South Dakota, Dyess AFB, Texas, Whiteman AFB, Missouri, and other locations as the Air Force determines support for the B-21 program. USACE values the shared contract capacity at $200M, with individual task order limits of $50M. The contract has an initial five-year base period with a two-year option period.

07:46 EDT PSEG accelerates 2030 climate net-zero goals - PSEG accelerated its net-zero goals by launching a three-pronged 2030 climate vision which comprises three pillars: net-zero emissions for PSEG operations, including PSE&G's utility operations; 100% greenhouse gas- , carbon-free power generation; and significant contributions to regional economy-wide decarbonization. PSEG's pivot to 100% carbon-free generation is in line with President Biden's goal of decarbonizing the U.S. electric sector by 2035. PSEG's regulated electric and gas utility, Public Service Electric & Gas, aims to achieve net-zero GHG emissions for its electric and gas utility operations by 2030. To accomplish this goal in less than 10 years, PSEG will leverage a suite of strategies - from modernizing its existing natural gas and electric transmission and distribution networks to investing in new technologies that support greater electrification and improve energy efficiency. PSEG will direct half of its current 2021-to-2025 capital spending program of approximately $14B-$16B toward decarbonization, emission reduction, methane reduction, clean energy transition and climate/storm adaptation. By 2030, PSEG plans to transition its power generation portfolio to 100% GHG-free resources by aiming to preserve carbon-free nuclear generation and investing in utility-scale renewables.

07:39 EDT Vitalhub announces 5-year licensing contract with Family Service Toronto - VitalHub announced the closing of a 5-year licensing contract, following a competitive RFP process with Family Service Toronto, to implement the use of the Company's TREAT Client Management and Care Coordination solutions. Family Service Toronto selected VitalHub's TREAT platform to replace their incumbent Case Management System used since 2005. The deal comprises a 5-year licensing contract for use of VitalHub's TREAT Client Management and Care Coordination software solutions.

07:37 EDT South Africa's Vox selects Minim cloud software for home WiFi experience - Minim announced that Vox has chosen Minim's AI-driven cloud software platform, mobile app, and customer care portal to underpin the Vox Wi-Fi Home Manager, a mobile app offering full Wi-Fi management, visibility, threat detection and device management. Wi-Fi Home Manager will initially be available to all Vox customers with the MikroTik hAP AC router and bundled in with all Fiber To The Home sales.

07:35 EDT Colliers launches global partnership with Blue Skyre to innovate its services - Colliers announced a global partnership with Blue Skyre to accelerate the growth of an innovative Facilities Management Advisory offering. "Colliers' differentiated advisory and consulting service helps clients improve their internal FM capabilities and organizational models, enhance supply chain performance by utilizing multiple FM service providers, and implement agile technology solutions. This global service offering benefits from Colliers' independent position in the FM space and expands upon the FM advisory and consulting services already provided across Colliers' Europe, Middle East and Africa region," the company said. Under the global agreement, Blue Skyre will co-brand as a Colliers Global Strategic Partner to jointly deliver strategic FM advisory and consulting services.

07:32 EDT Intellia Therapeutics names Basta as Executive Vice President - Intellia Therapeutics (NTLA) announced the appointment of James Basta, J.D., as Executive Vice President, General Counsel and Corporate Secretary. Basta is coming to Intellia with more than 25 years of combined in-house corporate and law firm experience, most recently as Chief Legal Officer at Kura Oncology (KURA). Basta succeeds Jose Rivera, one of Intellia's founding employees in 2014, who has served as Executive Vice President, General Counsel and Corporate Secretary, since then. Rivera will serve as special advisor to Basta to ensure a smooth transition and advise on key legal matters.

07:29 EDT EU commercial vehicle registrations up 51.3% in May - In May, the EU commercial vehicle market enjoyed another month of strong gains on the back of a low base of comparison due to last year's COVID-19 restrictions, reported the European Automobile Manufacturers Association. New registrations increased by 51.3% to 165,363 units, more than 30,000 below pre-pandemic volume levels, the group said. Five months into 2021, demand for new commercial vehicles in the EU increased by 43.9%, the group added. Publicly traded truck makers and suppliers include Daimler AG (DDAIF), Paccar (PCAR), CNH Industrial (CNHI), Navistar (NAV), Cummins (CMI) and Allison Transmission (ALSN). Reference Link

07:23 EDT 4D Molecular announces expected upcoming milestones - 4D-125: Initial biologic activity data from the Phase 1/2 clinical trial of 4D-125 in XLRP are expected in the fourth quarter of 2021, following at least nine months follow-up for all currently enrolled patients. 4D-110: Initial biologic activity data from the Phase 1 clinical trial of 4D-110 in choroideremia are expected in the fourth quarter of 2021, following at least six months follow-up for all currently enrolled patients and completion of the 90-day transition period with Roche. Additionally, after regaining full-rights to 4D-110, 4DMT plans to submit to FDA safety and efficacy data along with a new clinical study protocol, and to initiate a new clinical trial as soon as possible, that enrolls earlier stage patient populations. 4D-310: Initial clinical data from the Phase 1/2 clinical trial of 4D-310 in Fabry disease are expected in the second half of 2021. 4D-150: Initiation of a clinical trial with 4D-150 in wet AMD and diabetic macular edema is expected in the fourth quarter of 2021. 4D-710: Initiation of a clinical trial with 4D-710 in cystic fibrosis lung disease is expected in the fourth quarter of 2021.

07:22 EDT Eli Lilly jumps on expedited plans for Alzheimer's drug, Biogen falls - Eli Lilly (LLY) announced that the Food and Drug Administration granted Breakthrough Therapy designation for donanemab, its investigational antibody therapy for Alzheimer's disease. Lilly intends to submit a biologics license application for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. The safety, tolerability and efficacy of donanemab are also being evaluated in the ongoing Phase 3 study TRAILBLAZER-ALZ 2, the company said in a statement. The Phase 2 trial, TRAILBLAZER-ALZ, studied the efficacy and safety of donanemab in patients with early, symptomatic Alzheimer's. Shares of Eli Lilly are up 9%, or $18.50, to $235.60 following the news. Shares of Biogen (BIIB), who recently received FDA approval for its Alzheimer's treatment, are down 6% to $350.02 in premarket trading.

07:21 EDT Vectivbio receives FDA orphan drug designation for apraglutide - VectivBio announced that the FDA has granted orphan drug designation to apraglutide, a next-generation, long-acting GLP-2 analog being developed for rare gastrointestinal diseases, for the prevention of acute graft-versus-host disease, or GVHD. VectivBio plans to initiate a Phase 2 trial evaluating apraglutide for the treatment of aGVHD in the first quarter of 2022. "Gastrointestinal damage is a leading cause of death in patients with acute GVHD," said Omar Khwaja, M.D., Ph.D., Chief Medical Officer of VectivBio. "Preclinical and clinical studies evaluating apraglutide and GLP-2 analogs in acute GVHD indicate that apraglutide's regenerative and anti-inflammatory effects on the GI tract may significantly reduce morbidity and mortality in patients suffering from intestinal GVHD. We are eager to assess apraglutide's potential to prevent and treat this life-threatening disease and look forward to sharing our Phase 2 plans later this year."

07:19 EDT Werewolf Therapeutics set to join Russell 2000 Index - Werewolf Therapeutics announced that it will be added to the Russell 2000 Index at the conclusion of the Russell US Indexes annual reconstitution on June 28, 2021.

07:18 EDT 4D Molecular announces termination of Roche collaboration, license agreement - Roche (RHHBY) requested that 4DMT (FDMT) conclude the Roche-funded 4D-110 trial in advanced choroideremia patients as a result of Roche's assessment of a change in the risk-benefit profile. Subsequently, Roche sent a notice of termination without cause of the Collaboration and License Agreement, effective as of September 16, 2021. As a result, 4DMT will regain full rights to 4D-110. 4DMT has not changed its position on the potential of 4D-110 for choroideremia, a devastating blinding disease with no approved therapies. Based on the totality of the data generated to date, 4DMT intends to continue clinical development. The company plans to submit to FDA safety and efficacy data from the completed Phase 1 clinical trial along with a new clinical study protocol as soon as possible. 4DMT will conclude the Roche-funded clinical trial under the collaboration and plans to subsequently transfer previously treated patients onto a 4DMT-sponsored long-term follow-up study to continue monitoring biologic activity endpoints, safety and tolerability.

07:16 EDT Bio-Techne and Catamaran Bio expand collaboration for CAR-NK cell therapies - Bio-Techne and Catamaran Bio are expanding their collaboration for the development of cell engineering and cell process technologies for use by Catamaran in the manufacturing of CAR-NK cell therapy products. The companies have now broadened the scope of their collaboration to include the development of novel cell expansion technologies for use in the manufacturing of CAR-NK cell therapy products. In addition, Catamaran has secured a broad worldwide license to Bio-Techne's rights related to the TcBuster transposon system for use in the research, clinical and commercial manufacturing of next generation allogeneic cell therapy products. The initial collaboration between Catamaran and Bio-Techne, which began in 2020, has been focused on optimizing the application of the TcBuster transposon system to CAR-NK cell engineering. The TcBuster transposon system was discovered in the lab of Catamaran's scientific co-founder, and acquired by Bio-Techne in 2019. Bio-Techne will contribute cell expansion technologies and both companies will contribute know-how to enable large-scale production of functional CAR-NK cells.

07:15 EDT Applied Genetic reports 12-month data from ongoing Phase 1/2 trial of ACHM A3 - Applied Genetic Technologies reported 12-month data from its ongoing achromatopsia Phase 1/2 clinical trials. The path forward for ACHM A3 will be determined after additional pediatric patient data and pre-clinical studies are available and can be evaluated. 12-month data for ACHM A3 are available for 20 patients, including 16 adults and 4 pediatric patients. The results at this time point do not show consistent evidence of ACHM A3 candidate biologic activity, although we believe that the patient-reported anecdotes continue to be encouraging. In contrast with patients in the B3 trial, the majority of whom have mutations that results in the complete absence of B3 protein, the majority of A3 patients have mutations that result in the production of non-functional protein. The results observed to date in the Phase 1/2 ACHM trials suggest that the presence of these non-functional proteins may interfere with the activity of the vector expressed ACHM A3 protein.

07:15 EDT Darden reports Q4 blended same-restaurant sales up 90.4% y/y - Q4 same-restaurant sales by segment on y/y basis: +61.9% for Olive Garden; +143.6% for Fine Dining; +107.5% for LongHorn Steakhouse; +160.7% for Other Business.

07:12 EDT Navidea unit MT wins case against Michael Goldberg for breach of fiduciary duty - Navidea Biopharmaceuticals announced that on June 23, Vice Chancellor Joseph Slights of the Court of Chancery of the State of Delaware ruled in favor of Navidea's wholly-owned subsidiary, Macrophage Therapeutics and against its former CEO, Dr. Michael Goldberg, finding that Dr. Goldberg breached his fiduciary duties to MT. This decision follows an earlier June 12, 2019 ruling in which the Court voided certain transactions putatively authorized by Dr. Goldberg, pursuant to which Dr. Goldberg purported to transfer certain of Navidea's intellectual property rights, which had been sub-licensed to MT to a company controlled by Dr. Goldberg, but had previously ruled that there remained factual questions as to whether Dr. Goldberg's conduct constituted a breach of fiduciary duty to MT. Following a three-day trial and extensive post-trial briefing, the Court agreed with MT that Dr. Goldberg breached his fiduciary duty. Specifically, the Court ruled: "Dr. Goldberg attempted to take for himself that which belonged to. In doing so, he breached his duty of loyalty to [MT] stockholders. was absolutely justified in bringing this action to remedy (in this case undo) the harm caused by Dr. Goldberg's misconduct." The Court disagreed with MT's arguments regarding damages and, other than awarding nominal damages, declined to award additional relief beyond that which it had previously granted. With respect to MT's claim for conversion, the Court found that the claim was not supported because "Dr. Goldberg confirmed that he currently does not own or possess any intellectual property related to either Navidea or and that "any IP Dr. Goldberg created while at Navidea or any of its subsidiaries was and remains the property of Navidea and its subsidiaries."

07:11 EDT Fulcrum Therapeutics says losmapimod was well tolerated in ReDUX4 trial - Losmapimod-treated participants showed decreased progression in the treatment efficacy composite measure of muscle fat infiltration as measured in intermediate muscles, those most likely to change. Normal appearing muscles appeared to be preserved in the losmapimod group versus placebo based on a post hoc analysis. Muscle fat infiltration is a measure of diffuse fatty infiltration in lean muscle tissue that is correlated with disease severity in FSHD. Participants in ReDUX4 trial were assessed with a quantitative whole body musculoskeletal magnetic resonance imaging which provides a holistic evaluation of skeletal musculature with the ability to volumetrically measure fat replacement of skeletal muscle in FSHD. Prior clinical trials have demonstrated that the amount of muscle fat replacement correlates with muscle function in many neuromuscular diseases, including FSHD. Furthermore, changes in fat content are correlated with changes in function. Taken together, ReDUX4 demonstrated that this MRI technology has sufficient sensitivity to detect FSHD relevant disease progression. Treatment with losmapimod was shown to slow the rate of decline and improve accessible surface area in Reachable Workspace measures. Prior studies have shown that RWS correlates with changes in the ability of patients to independently perform activities of daily living. Based on published results, reachable workspace is an important measure of disability. The disease tends to progress from the upper body down, and loss of shoulder movement leads to loss of mobility. Participants in the losmapimod group showed improvements of up to 1.5% from baseline in the accessible surface area when using a 500g weight on their wrist compared to placebo. Participants in the placebo group were able to access 2 to 4% less total surface area measured by RWS after 48 weeks. Participants reported feeling better when treated with losmapimod compared to placebo through the Patient Global Impression of Change assessment. PGIC, a measure of self-reported change in how a patient feels and functions, showed that participants were able to recognize improvements after 48 weeks of treatment. More participants in the losmapimod group reported improvement at 48 weeks compared to placebo. Four times more losmapimod participants reported improvement over time as compared to participants treated with placebo. Importantly, fewer losmapimod participants reported worsening as compared to placebo, and no losmapimod participants reported being "much worse" as compared to more than 13% of placebo participants, who reported that their disease had become "much worse." Additional secondary and exploratory endpoints measuring disease progression and function demonstrated differences between losmapimod and placebo at week 48. In a post hoc analysis, dynamometry, which measures muscle strength, demonstrated that participants in the losmapimod group showed non-statistically significant trends of slower progression, as well as meaningful improvements in the strength of bilateral shoulder abductors and ankle dorsiflexors, two muscle groups particularly affected in FSHD, compared to placebo. Functional scales including RWS and TUG showed improvements in limb function consistent with dynamometry results. Two recently designed scales, did not demonstrate changes from baseline in either group or differences between losmapimod and placebo groups, suggesting that these tests are not sensitive to change over the 48-week time period. Motor function measure also showed no changes in either group or differences between the groups over 48 weeks. There was no difference in muscle fat fraction or lean muscle volume between losmapimod and placebo groups at 48 weeks in intermediate muscles. The Company believes it may observe statistically significant differences in these measures with more time. Additional MRI data will be presented during the IRC meeting. Fulcrum will continue to analyze data from each endpoint to determine their viability for future trials. Blood concentrations and target engagement in muscle were consistent with previous studies and were within the expected range for clinical efficacy. Safety and tolerability data were consistent with previously reported results with no drug-related serious adverse events reported. Losmapimod was generally well-tolerated and the majority of treatment emergent adverse events were deemed unlikely related or not related to study drug by the investigator. There were three serious adverse events reported in two participants in the losmapimod group, each assessed as unrelated to losmapimod. There were no deaths or discontinuations due to adverse events. Losmapimod has now been evaluated in over 3,600 subjects in clinical trials across multiple indications, including FSHD.

07:09 EDT Shutterstock signs partnership with photographer Miles Diggs - Shutterstock announced an exclusive editorial partnership with "celebrity street style photographer" Miles Diggs AKA "Diggzy." Diggzy's celebrity portraits have been featured in global publications, including VOGUE, The New York Times and Vanity Fair. Diggzy's collection of photography will form part of The Newsroom, a concierge service for access to exclusive premium content.

07:09 EDT STMicroelectronics collaborates with Arrival to provide technology for EVs - STMicroelectronics (STM) announced its collaboration with Arrival (ARVL) to provide semiconductor technologies and products for Arrival's vehicles including automotive microcontrollers and power and battery-management devices. "Arrival has chosen ST as one of its key partners in bringing its connected electric vehicles, or EVs, to market. ST's technology will provide Arrival's customers with future-proofed zero-emission commercial vehicles as part of an integrated mobility ecosystem. Arrival has selected ST's high-performance, secure automotive microcontrollers for their modular ECU platform, as well as other ST technologies including smart-power and battery-management devices for efficient vehicle electrification," the company said. Arrival's entire vehicle portfolio, including its Van, Bus, and recently announced Car, which is being designed in partnership with Uber (UBER) for ride-hailing, will feature ST's technologies.

07:07 EDT Canada Goose will stop using fur in its products - Canada Goose announced that it will end the use of all fur in its products. This announcement is driven by its focus on its purpose-based platform, HUMANATURE, relentless innovation, and expanding lifestyle relevance. Through a phased approach, Canada Goose will end the purchase of fur by the end of 2021 and cease manufacturing with fur no later than the end of 2022.

07:06 EDT Darden raises quarterly dividend 25% to $1.10 per share - Darden's Board of Directors declared a quarterly cash dividend of $1.10 per share, a 25% increase from third quarter fiscal 2021, on the company's outstanding common stock. The dividend is payable on August 2 to shareholders of record at the close of business on July 9.

07:04 EDT Zealand Pharma announces U.S. commercial availability of ZEGALOGUE injection - Zealand Pharma announced that ZEGALOGUE injection 0.6mg/0.6mL is now commercially available in the U.S. in both an auto-injector and prefilled syringe. "We are thrilled to announce that ZEGALOGUE is now available to support people with diabetes and their caregivers," said Frank Sanders, President of U.S. Operations for Zealand Pharma. "One of the most frightening aspects of living with type 1 diabetes is the ever-present worry that an unexpected severe hypoglycemic event could occur at any time. This can be especially worrisome for people who are preparing for travel, the back to school season with a resumption of in-person learning, and other events away from home after a long period of isolation during the pandemic. The commercial availability of ZEGALOGUE brings us one step closer to helping people feel confident and prepared to address the unpredictable nature of severe hypoglycemia." The program includes co-pay support for eligible commercially insured patients who may pay $25 for up to two ZEGALOGUE devices per fill, and the opportunity to receive home prescription delivery. The U.S. Food and Drug Administration approved ZEGALOGUE on March 22, 2021 for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

07:03 EDT Aravive announces initial results from Phase 1b portion of study of AVB-500 - Aravive announced "positive" initial results from the Phase 1b portion of its Phase 1b/2 study in patients dosed with 15mg/kg of AVB-500 in combination with cabozantinib who have clear cell renal cell carcinoma. The data in three evaluable patients showed that AVB-500 was well tolerated with no unexpected findings. Based on the pharmacokinetics, pharmacodynamics, and safety data at 15mg/kg of AVB-500, and approval by the Data and Safety Monitoring Board, the company plans to expand the dosing of 15mg/kg of AVB-500 to an additional three patients to determine the potential of initiating the Phase 2 portion with this dose. The company also expects to continue to investigate higher doses of AVB-500 in the Phase 1b to obtain additional safety, pharmacokinetics, and pharmacodynamics information. "We are pleased to announce the favorable results in the first cohort of our clear cell renal cell carcinoma Phase 1b study, as we continue to advance AVB-500 and evaluate its ability to address an urgent, high unmet medical need in patients with advanced kidney cancer who have very low survival rates," said Gail McIntyre, Ph.D., CEO of Aravive. "We continue to focus on difficult-to-treat life threatening cancers with AVB-500, and in addition to our clear cell renal cell carcinoma clinical trial, our lead indication in paclitaxel resistant ovarian cancer is in a Phase 3 clinical trial, and we recently announced that we plan to initiate a Phase 1b/2 clinical trial in first-line metastatic pancreatic cancer in the second half of this year. We are enthusiastic about the clinical data with AVB-500 in combination with anticancer therapies that continue to show consistent PK/PD data and a favorable safety profile. These combinations may have the potential to be used in a range of different cancers."

07:01 EDT Darden reports Q4 blended same-restaurant sales up 90.4%

06:58 EDT Aecom selected by New Jersey Turnpike Interchange for management services - Aecom has been selected to provide program management services for the New Jersey Turnpike Authority's $1.1B Interchange 1 to 4 Widening Program. Aecom will provide program management, preliminary engineering, and environmental services for the project's permitting, design, and construction phases. In addition to increasing mobility, the Interchange 1 to 4 Widening Program provides the Authority the opportunity to make further improvements.

06:55 EDT Velodyne Lidar launches India Design Center in Bangalore - Velodyne Lidar launched its new India Design Center in Bangalore. The India Design Center will closely collaborate with Velodyne's San Jose, Calif.-based engineering team in R&D to build customer-focused solutions. The center will be led by Parthasarathy Narasimhan, who has joined Velodyne as Vice President of Engineering and Managing Director of the India Design Center. Narasimhan most recently worked at OpenSilicon. In addition to R&D, the center will foster customer and partner opportunities in India for lidar-based solutions in automotive and new mobility.

06:52 EDT KKR announces intra-quarter monetization activity for Q2 - KKR announced a monetization activity update for the period from April 1, 2021 through June 24, 2021. Based on information available to us as of today, with respect to the period through June 24, 2021, KKR has earned gross realized carried interest and realized investment income in excess of $900M, of which approximately 65% is gross realized carried interest and approximately 35% is realized investment income. This is driven primarily by strategic and secondary sale transactions that have closed quarter to-date, as well as dividend and interest income from KKR's balance sheet portfolio. The estimate disclosed above is not intended to predict or represent the total revenues for the full quarter ending June 30, 2021, because it does not include the results or impact of any other sources of income, including fee income, losses or expenses. This estimate is also not necessarily indicative of the results that may be expected for any other period, including the entire year ending December 31, 2021.

06:51 EDT Eagle Pharmaceuticals: FDA maintains prioritization of ANDA for vasopressin - Eagle Pharmaceuticals announced that the U.S. FDA has maintained Priority Review for the company's Abbreviated New Drug Application for vasopressin. The company's response to the CRL was submitted on June 15. The FDA has assigned a GDUFA date of December 15, 2021, and the company expects a commercial launch prior to year-end. Eagle is first to file an ANDA referencing Vasostrict, which had total U.S. sales of $786M in 2020.

06:46 EDT Eli Lilly receives breakthrough therapy designation for donanemab from FDA - The FDA granted breakthrough therapy designation for donanemab, Eli Lilly's investigational antibody therapy for Alzheimer's disease, or AD.

06:27 EDT AstraZeneca's Lynparza approved in China to treat mCRPC - AstraZeneca (AZN) and Merck's (MRK) Lynparza, or olaparib, has been granted conditional approval in China to treat adult patients with germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, or mCRPC, who have progressed following treatment that included a new hormonal agent. The approval by China's National Medical Products Administration was based on a subgroup analysis of the PROfound Phase III trial, which showed that Lynparza demonstrated a substantial improvement in radiographic progression-free survival and overall survival versus abiraterone or enzalutamide in men with BRCA1/2 mutations. Continued approval is contingent upon verification and description of clinical benefit in a planned bridging trial with Chinese patients. The subgroup analysis from the PROfound Phase III trial showed Lynparza reduced the risk of disease progression or death by 78% and improved rPFS to a median of 9.8 months versus 3.0 with abiraterone or enzalutamide in men with mCRPC with BRCA1/2 mutations. In addition, Lynparza reduced the risk of death by 37% with median OS of 20.1 months versus 14.4 with abiraterone or enzalutamide. Reference Link

06:03 EDT NexGen Energy to list on ASX - NexGen Energy announced that it has filed a prospectus with the Australian Securities and Investments Commission in connection with NexGen's application for admission to the Australian Securities Exchange, or ASX, as a Foreign Exempt Listing and quotation of its shares as Chess Depositary Instruments on July 2 under the code "NXG". Further, NexGen is in the final stages of preparing for a 2021 exploration program at Rook I. This program will focus on known prospective targets incorporating geological data sets and surveys accumulated over the last 10 years. The Patterson Corridor alone on the Rook I Property that hosts the Arrow Deposit, has over 90% yet to be explored. In addition, the Rook I property hosts an additional 8 known corridors running parallel to the east of the Patterson which are all yet to be drilled. The proposed exploration program is scheduled to commence in the coming months incorporating and subject to the exploration, health and safety protocols administered by the Provincial Government and Health Authority.

05:36 EDT Philip Morris calls for representatives to combat illicit cigarettes - Philip Morris is calling for public and private representatives to jointly combat illicit trade as a new report produced by KPMG was released on the consumption and flows of illicit cigarettes in 30 European countries-the 27 European Union, or EU, member states, as well as U.K., Norway and Switzerland. The study estimates that, while total cigarette consumption continues to decline, the share of illicit cigarettes increased by one half of a percentage point to 7.8% of total consumption in 2020, reaching 34.2B cigarettes consumed across the EU 27 member states, or EU27. The increase of illicit cigarettes-which consist of contraband, counterfeit, and illicit whites-was driven by an unprecedented 87% surge in counterfeit consumption. The tax loss for governments in the EU27 now amounts to approximately EUR 8.5B. The annual study, conducted independently by KPMG and commissioned by PMI, shows how legal and illicit cigarette consumption was impacted by the COVID-19 pandemic, a period of lockdowns and restricted movement of people within the EU coupled with declines in affordability. The report estimates that total consumption of cigarettes declined by 4.7% in 2020 to 438.8B in the EU27, while the COVID-19-related border controls and travel restrictions resulted in a sharp decrease of non-domestic consumption, which declined in 2020 by 18.5%. It is noted that the decline in total cigarette consumption also coincided with the growth of 6B cigarette equivalent units in the fine cut tobacco category in 2020. Consumption of illicit whites and other contraband cigarettes decreased year-over-year, but these declines were more than offset by an increase in counterfeit, which almost doubled in 2020, equating to 10.3B fake cigarettes, up from 5.5B in 2019. This was estimated to be driven mainly by an unprecedented 609% increase in counterfeit cigarette consumption in France, reaching 6B fake cigarettes consumed in the country alone.

05:26 EDT Genentech announces FDA acceptance of Port Delivery System with ranibizumab BLA - Genentech, a member of the Roche Group, announced that the FDA has accepted the company's biologics license application, or BLA, under priority review, for Port Delivery System with ranibizumab, or PDS, for the treatment of wet, or neovascular, age-related macular degeneration, or AMD. Wet AMD is a leading cause of blindness for people aged 60 and over and impacts approximately 1.1M people in the United States. If approved, PDS would be a first-of-its-kind therapeutic approach, offering people living with wet AMD an alternative to frequent eye injections of anti-vascular endothelial growth factor, the current standard of care. The FDA is expected to make a decision on approval by October 23.

05:20 EDT Visa to acquire Tink for EUR 1.8B - Visa announced it has signed a definitive agreement to acquire Tink, a European open banking platform that enables financial institutions, fintechs and merchants to build financial management tools, products and services for European consumers and businesses based on their financial data. Visa will pay total financial consideration of EUR 1.8B, inclusive of cash and retention incentives, to acquire Tink. Through a single API, Tink allows its customers to access aggregated financial data, use financial services such as risk insights and account verification and build personal finance management tools. Tink is integrated with more than 3,400 banks and financial institutions, reaching millions of bank customers across Europe. Tink will retain its brand and current management team, and its headquarters will remain in Stockholm, Sweden. The transaction is subject to regulatory approvals and other customary closing conditions. Visa will fund the transaction from cash on hand and this transaction will have no impact on Visa's previously announced stock buyback program or dividend policy.

05:04 EDT iMedia Brands announces relaunch of CBK brand - iMedia Brands announced its leveraging of ShopHQ to accelerate the relaunch of the 65-year-old Christopher & Banks brand, or CBK, in the United States. CBK was founded in 1956 and is a brand that specializes in offering women's apparel and accessories. For FY19, CBK reported approximately $349M in revenue, with approximately $79M in digital-only revenue and approximately $269M in brick-and-mortar retail and other revenue. For FY20, CBK reported approximately $171M in revenue in the first nine months. "Less than four months ago iMedia acquired this amazing brand that has over 1.5 million passionate and loyal customers," said Tim Peterman, iMedia's CEO. "I'm excited to report that our progress on the integration and relaunch of CBK has been swift and meaningful."