Stockwinners Market Radar for August 19, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:02 EDT GE signs power infrastructure pacts with Iraq valued at over $1.2B - General Electric said that the Government of Iraq is accelerating its focus on strengthening the nation's power infrastructure through two new agreements signed with GE. GE signed the agreements, valued at over $1.2B, with the Iraqi Ministry of Electricity to execute the power sector projects that will secure reliable power supply across the country. Accordingly, GE Gas Power will undertake contracts valued at $500M for the upgrade and maintenance of key power plants in the country, which are mission-critical to sustain the power supply of over 6,000 MW and scale up operational efficiency. Further, GE's Grid Solutions, having secured a contract valued at $727M in a landmark agreement, will reinforce Iraq's transmission network and interconnection with the electricity grid of Jordan. In addition to delivering the scope of services, GE will also work with multiple export credit agencies to facilitate the discussion of financing over $1B for the projects.

18:36 EDT SeaWorld San Diego says 'big news coming soon' - SeaWorld San Diego said in a Facebook post: "Big news coming soon, stay tuned!" The Fly notes that SeaWorld has been closed due to the COVID-19 pandemic. Reference Link

17:52 EDT MSG Networks down 1.3% after executives sell shares - Shares of MSG Networks are down 1.32% or 14c to $10.50 per share in after-hours trading after reports of insider share sales.

17:44 EDT Procter & Gamble CFO sells 45.6K shares of common stock - In a regulatory filing, Procter & Gamble disclosed its CFO Jon Moeller sold 45.6K shares of common stock on August 19th in a total transaction size of $6.2M.

17:35 EDT Carl Icahn boosts stake in Xerox to 12.82% - Icahn may be deemed to be the beneficial owner of, in the aggregate, 27,304,619 Xerox shares. The aggregate purchase price of the Xerox shares purchased by the Icahn collectively was approximately $705.8M. The source of funding for the Xerox shares held by Icahn was the general working capital of the respective purchasers. The Xerox shares held by Icahn are held in margin accounts together with other securities. Such margin accounts may from time to time have debit balances. Part of the purchase price of such Shares was obtained through margin borrowing. Icahn may be deemed to beneficially own, in the aggregate, 27,304,619 Shares, representing approximately 12.82% of the Issuer's outstanding Shares. The Icahn stake in Xerox increased to 12.82% from 12.48%. The stake was reported in a 13D filing and allow for activism.

17:28 EDT Intel up 2.5% at $49.53 per share after initiating $10B stock buyback

17:23 EDT Beneficial owner Carl Icahn buys over $13M in Xerox shares - Carl Icahn disclosed in a filing that he had purchased 725,935 shares of Xerox stock at an average price of $18.12 per share between August 17 and August 19 for a total transaction value of $13,156,265.

17:16 EDT MSG Networks VP Dawn Darino-Gorski sells 20K shares of company stock - MSG Networks VP Dawn Darino-Gorski disclosed in a filing that she had sold 20,000 shares of company stock at an average price of $10.12 per share on August 18 for a total transaction value of $202,400.

17:14 EDT Golub Capital CEO buys 132K shares of common stock - In a regulatory filing, Golub Capital disclosed its CEO David Golub bought 132.4K shares of common stock on August 17th-18th in a total transaction size of $1.7M.

17:12 EDT Medtronic says primary endpoint results from IN.PACT AV trial published in NEJM - Medtronic announced the publication of the primary endpoint results from the IN.PACT AV Access trial in The New England Journal of Medicine. The results reinforce that the IN.PACT AV drug-coated balloon limits the number of reinterventions needed to maintain blood flow in patients with end-stage renal disease who have arteriovenous fistulae, leading to fewer interruptions to their dialysis therapy. Nearly 2.5 million ESRD patients worldwide regularly undergo hemodialysis - many of whom require AV fistulae in order to receive continuous dialysis. For these patients, AV fistulae serve as lifelines, and maintaining access to these sites is essential. Vessels that feed the access site can narrow (restenose) over time, however, and patients often undergo multiple maintenance procedures per year to restore access site function. The need for frequent reinterventions can result in repeated hospital visits and significant disruptions to critical hemodialysis care. Therefore, by being able to maintain access site patency, patients may experience longer periods of successful, uninterrupted dialysis.

17:05 EDT Activision Blizzard unveils 'Call of Duty Black Ops: Cold War' - In an official teaser trailer released on YouTube, Activision Blizzard has confirmed that the next game in its "Call of Duty" franchise will be named "Call of Duty Black Ops: Cold War." The company noted at the end of the trailer that the game will get a "worldwide reveal" on August 26. Reference Link

16:59 EDT Facebook removes hundreds of QAnon-connected pages, groups - Facebook said it is taking action against Facebook Pages, Groups and Instagram accounts tied to offline anarchist groups that support violent acts amidst protests, US-based militia organizations and QAnon. "We already remove content calling for or advocating violence and we ban organizations and individuals that proclaim a violent mission," the company said. "However, we have seen growing movements that, while not directly organizing violence, have celebrated violent acts, shown that they have weapons and suggest they will use them, or have individual followers with patterns of violent behavior. So today we are expanding our Dangerous Individuals and Organizations policy to address organizations and movements that have demonstrated significant risks to public safety but do not meet the rigorous criteria to be designated as a dangerous organization and banned from having any presence on our platform." "As a result of some of the actions we've already taken, we've removed over 790 groups, 100 Pages and 1,500 ads tied to QAnon from Facebook, blocked over 300 hashtags across Facebook and Instagram, and additionally imposed restrictions on over 1,950 Groups and 440 Pages on Facebook and over 10,000 accounts on Instagram," Facebook added. "These numbers reflect differences in how Facebook and Instagram are used, with fewer Groups on Facebook with higher membership rates and a greater number of Instagram accounts with fewer followers comparably. Those Pages, Groups and Instagram accounts that have been restricted are still subject to removal as our team continues to review their content against our updated policy, as will others we identify subsequently. For militia organizations and those encouraging riots, including some who may identify as Antifa, we've initially removed over 980 groups, 520 Pages and 160 ads from Facebook. We've also restricted over 1,400 hashtags related to these groups and organizations on Instagram." Reference Link

16:41 EDT Airbnb confidentially submits draft registration for IPO - Airbnb confidentially submitted a draft registration statement on Form S-1 to the SEC relating to the proposed initial public offering of its common stock. The number of shares to be offered and the price range for the proposed offering have not yet been determined. The initial public offering is expected to take place after the SEC completes its review process, subject to market and other conditions.

16:35 EDT International Game Technology and Boyd Gaming in sports betting technology pact - International Game Technology (IGT) announced that it has signed a long-term sports betting technology agreement with leading U.S. casino operator Boyd Gaming (BYD). Under the terms of the agreement, Boyd Gaming will utilize IGT's PlaySports platform to support Boyd Gaming's retail sportsbooks throughout Nevada, along with its Nevada-based mobile sports app and online sports betting portal. Additionally, Boyd Gaming will deploy IGT's self-service PlaySports Kiosks throughout its Nevada-based gaming venues. IGT and Boyd Gaming will take a phased approach for rolling out the features and services associated with this technology agreement. "IGT and Boyd Gaming will create a dynamic omnichannel sports betting product that is sure to stand apart in Nevada, the most mature and high-volume sports betting destination in the U.S.," said Enrico Drago, IGT PlayDigital Senior Vice President. "IGT's PlaySports platform enables Boyd Gaming to differentiate its sports betting product in meaningful ways that position them to attract new players and grow revenue in the segment." In addition to offering players a more robust and progressive sports betting program, the PlaySports platform will allow Boyd Gaming to offer improved backend system navigation, and seamlessly update app content in line with real-time data and betting trends. Players will also be able to enjoy a range of new bets, features and conveniences. IGT and Boyd Gaming have maintained a sports betting relationship in the U.S. since 2018. In addition to Boyd Gaming's Nevada-centric sports betting product, the PlaySports platform is powering sports betting at Boyd Gaming-owned properties in Pennsylvania, Iowa, Indiana and Mississippi.

16:32 EDT Nordson sees Q4 revenue 'commensurate with slightly better Q3' - The company states: "While the short-term environment remains difficult to predict, we expect Q4 revenue to be commensurate with to slightly better than fiscal third quarter revenue based on the current order entry trends and order backlog. Weekly order entry rates have improved from the lower levels experienced during the third quarter. Entering the fourth quarter, trailing four-week order entry is 93% of prior year levels and backlog totaled $423 million. Operating profit is forecasted to improve modestly in the fiscal fourth quarter compared to the third quarter, as cost reduction initiatives begin to deliver benefits."

16:29 EDT L Brands reports Q2 overall SSS up 33%

16:23 EDT L Brands reports Q2 Bath & body Works comparable store sales increased 87% - Reports Q2 Victoria's Secret sales decreased 10%. Comparable store sales figures are calculated from the period in which stores were open.

16:17 EDT TransUnion appoints Teedra Bernard as Chief Talent and Diversity Officer - TransUnion has appointed Teedra Bernard the company's first-ever Senior Vice President and Chief Talent and Diversity Officer. In this role, effective immediately, Bernard is responsible for all of TransUnion's global talent functions across the associate lifecycle, including talent acquisition, employment branding, onboarding, associate and manager training, leadership development, career development, employee engagement and experience, and employee relations. She reports to Anne Leyden, Executive Vice President and Chief Human Resources Officer, and serves as an advisor to the entire TransUnion executive team. "We are committed to making TransUnion a more diverse and inclusive company, and aligning all of our talent functions under a new leadership role will ensure a diversity and inclusion lens is present in everything we do," said Chris Cartwright, TransUnion President and CEO. "The ability to attract and nurture top talent is critical to an information and insights company like TransUnion, and I have full confidence in Teedra's ability to lead this important function."

16:16 EDT Community Bank System raises quarterly dividend 2.4% to 42c per share - Community Bank System announced that it has declared a quarterly cash dividend of 42c per share on its common stock. The dividend will be payable on October 9, 2020 to shareholders of record as of September 15, 2020. The 42c cash dividend represents a 1c, or 2.4%, increase and an annualized yield of 2.86% based on the closing share price of $58.71 on August 18, 2020. This increase marks the twenty-eighth consecutive year of dividend increases for the company.

16:15 EDT Teck names Harry "Red" Conger COO, appoints Jonathan Price CFO - Harry "Red" Conger has been appointed as Teck's (TECK) Executive Vice President and Chief Operating Officer, effective September 1. Conger most recently held the role of President and COO - Americas with Freeport-McMoRan (FCX). Jonathan Price has been appointed as Teck's Senior Vice President and Chief Financial Officer, effective October 1. Mr. Price succeeds Ron Millos, who has recently announced his retirement.

16:13 EDT GoHealth CEO says 'strong Medicare Advantage enrollments' in Q2 - Clint Jones, co-founder and CEO said, "We delivered 71% revenue growth in the second quarter, powered by strong Medicare Advantage enrollments. Our strategic focus on LTV/CAC ensures that these high rates of growth convert into industry-leading margins and strong cash returns. Given the trajectory of our business and the investments we have been making in our direct-to-consumer marketplace, we believe we are on track for another record year of results in fiscal 2020." Jones continued, "GoHealth is one of the largest enrollers of Medicare Advantage plans in the United States. Our targeted marketing efforts help spur seniors to evaluate their Medicare plans as we continue to expand our carrier offerings and geographic footprint. The COVID-19 pandemic has accelerated the shift from traditional field agents to our technology enabled model, as consumers seek the expert advice of our agents from the comfort and safety of their homes. Importantly, we are rapidly scaling up in a fast growing, 60 million plus person market where our larger scale and leadership position will allow us to better help both consumers and carriers."

16:11 EDT Puma Bio says Phase II CONTROL interim results published in oncology journal - Puma Biotechnology announced the publication of interim results from its Phase II CONTROL trial of neratinib in the September 2020 Issue of Annals of Oncology. Previous studies of neratinib in HER2-positive early stage breast cancer showed that diarrhea was the most common adverse event associated with neratinib treatment. The international, open-label, sequential-cohort Phase II CONTROL trial is investigating several strategies to improve neratinib tolerability. Researchers used data on incidence, duration and onset of diarrhea in the pivotal, multi-center, randomized, double-blind, placebo-controlled Phase III ExteNET trial as a historical comparison. In the ExteNET trial, prophylactic use of anti-diarrheal medication was not mandatory. The interim results of the CONTROL trial discussed in this publication demonstrate that neratinib tolerability can be significantly improved using a variety of anti-diarrheal strategies. The most significant impact was seen using a dose escalation strategy with loperamide as needed, which included utilizing a lower dose of neratinib during the first two weeks of a 52-week treatment period. In the dose escalation cohort, of which patients completed one year of treatment or had the highest median treatment duration compared to other cohorts, grade 3 diarrhea was reduced by over 60% (CONTROL 15% versus ExteNet 40%), discontinuations by over 80% (CONTROL 3% versus ExteNet 17%), the need to dose reduce by almost 90% (CONTROL 3% versus ExteNet 26%) and no patients were hospitalized.

16:10 EDT Synopsys CEO says 'executed very well' in Q3 - "Synopsys again executed very well in the third quarter, delivering record revenue, non-GAAP earnings per share and operating cash flow. We saw double-digit revenue growth across all product groups and strength in all geographies. Our intense, multi-year innovation push is driving increased momentum in product successes and production adoptions," said Aart de Geus, chairman and co-CEO of Synopsys. "Even as the world navigates through the pandemic and economic challenges, global design activity and customer engagements are flourishing. Due to our very strong fiscal third quarter, confidence in our outlook and resilient business model, we are raising 2020 revenue, operating margin, non-GAAP earnings-per-share and operating cash flow targets."

16:10 EDT SS&C raises quarterly dividend to 14c from 12.5c per share - This is payable on September 15 to stockholders of record as of the close of business on September 1.

16:09 EDT AutoNation closing aftermarket collision parts business - AutoNation will close its aftermarket collision parts business, referred to as AutoNation Collision Parts by the end of 2020. The ACP business represented less than 1% of AutoNation's Parts and Service gross profit for the six months ended June 30. The company will continue its profitable PrecisionParts business, which includes the sale of branded maintenance and repair parts. AutoNation expects that the SG&A savings related to the closing of the ACP business will be approximately 100 basis points as a percentage of gross profit, and now targets operating below 68% SG&A as a percentage of gross profit beginning with Q3. In connection with the closing, the company currently estimates that it will incur charges in the second half of 2020 of approximately $52M, of which approximately $12M will be cash expenditures. The company also expects additional cash expenditures following the closing of approximately $9M related to existing contractual obligations. AutoNation has implemented a restructuring plan over the last two years that reduced costs annually and consolidated its region infrastructure from three to two regions.

16:05 EDT Ulta Beauty to close all stores on Thanksgiving Day 2020 - In preparation for the 2020 holiday season, Ulta Beauty announced its decision to close all stores on Thanksgiving, November 26, 2020. "The holiday season is when Ulta Beauty and our guests shine brightest," said Mary Dillon, chief executive officer. "Keeping our associates at the heart of our decisions always, we are adapting this season's plans to reflect our immense gratitude for their commitment to serving our stores, our guests and our communities throughout this unprecedented year. It's our hope that everyone takes time this Thanksgiving to see the beauty in togetherness with loved ones."

15:56 EDT Gold miners fall as 'yellow metal' drops amid Fed minutes, dollar stabilization - Shares of gold mining stocks dropped along with the metal amid a rally in the U.S. dollar and the worry the Fed expressed over the economy in the Fed minutes, released earlier today. The Federal Reserve said it saw minimal advantages from a yield curve control program, according to the minutes from the July monetary policy meeting. The fed said that "uncertainty surrounding the economic outlook remained very elevated, with the path of the economy highly dependent on the course of the virus and the public sector's response to it." The dollar strengthened amid the Fed's comments to support the U.S. economy. Additionally, the FOMC is concerned that the coronavirus crisis will pose "considerable risks" to the outlook in the medium term. Spot gold was down 1.6% to $1,968.84 per ounce, while U.S. gold futures slipped 1.7% to $1,979.20. BUFFET BUYS STAKE IN MINER: Warren Buffett's Berkshire Hathaway made an investment in Barrick Gold (GOLD). The stake was disclosed in an SEC filing of Berkshire's holdings as of June 30, 2020. Berkshire Hathaway bought 20.9M shares of Barrick Gold, worth about $564M at the end of June, according to its latest portfolio update. The miner was its only new holding over that time period. GOLD MINERS FALL: Shares of gold mining companies fell, including Barrick Gold, Newmont (NEM), Agnico (AEM), and Kinross Gold (KGC).

15:18 EDT Sypris Technologies receives order for Albert XPress Gas Project - Sypris Technologies, Inc., a subsidiary of Sypris Solutions, announced that it has recently received an order for its Tube Turns Tool-less closures. Production will begin immediately and is expected to be completed prior to year-end. Terms of the purchase were not disclosed. Brett Keener, General Manager of Sypris Technologies, commented, "This is another good example of a project that leverages our extensive experience in engineering high-quality closures for the demanding requirements to continually support major energy projects around the globe. We are proud to be a part of enhancing energy infrastructure with these types of important global projects." The Tube Turns Tool-less closure has been chosen for the Alberta XPress Project. According to the project website, AXP will utilize existing capacity on the Great Lakes Gas Transmission system and American Natural Resources pipeline system, with facility expansions taking place along ANR's Southeast Mainline. The combined effort will result in an addition of 165,000 Dth/d of incremental firm transmission capacity from the GLGT Emerson receipt point in Manitoba to delivery locations along ANR's SEML in the Midwestern and Southern U.S. As part of the ANR expansion, a new compressor station will be built in Evangeline Parish, Louisiana. This project has an estimated cost of $300M for compressor station and pipeline modifications to increase the performance of the system which will serve the rising demand for natural gas on the U. S. Gulf Coast and beyond. The Gulf Coast is the principal area in the U.S. for LNG export terminals. These closures will be up to 58" in diameter and rated to a pressure of 1,000 psi.

14:12 EDT Nautilus down 4% after CEO sells entire stake in company - Shares of Nautilus are lower after its CEO James Barr disclosed the sale of $619,682 of shares. Following the sales, which occured on August 17 and 18, Barr does not own any Nautilus shares directly. The stock in afternoon trading is down 4%, or 49c, to $13.16.

14:02 EDT Occidental to divest WY, CO, UT land grant assets to Orion for about $1.33B - Occidental announced it has entered into a purchase and sale agreement to divest Wyoming, Colorado, and Utah Land Grant assets to Orion Mine Finance for approximately $1.33B. The transaction, which is expected to close in the fourth quarter of 2020, has a footprint of approximately 4.5M mineral acres and 1 million fee surface acres. Occidental will retain all cash flow from currently producing oil and gas properties on the position, which are primarily cost-free royalties. Not included in the sale is approximately 2.5M mineral acres derived from the land grant in Colorado, including Occidental's core DJ Basin position. In this transaction, Orion is acquiring mineral rights to the world's largest known trona deposit. Trona is a mineral used to make soda ash, the principal ingredient in baking soda, global glass manufacturing, pollution control systems, as well as other critical chemical applications. The acquired properties will be held under Sweetwater Royalties, a new base metals and industrial minerals royalty company, managed by Orion. "This transaction significantly advances the progress against our $2 billion plus divestiture target for 2020," said President and CEO Vicki Hollub. "We will retain our core oil and gas assets in the Rockies, including the prolific DJ Basin in Colorado and the highly prospective Powder River Basin in Wyoming."

14:01 EDT North American rail traffic dropped 7.5% in the week ended August 15 - The Association of American Railroads, AAR, reported U.S. rail traffic for the week ending August 15. For this week, total U.S. weekly rail traffic was 500,563 carloads and intermodal units, down 6.9% compared with the same week last year. Total carloads for the week ending August 15 were 222,353 carloads, down 15.9% compared with the same week in 2019, while U.S. weekly intermodal volume was 278,210 containers and trailers, up 1.9% compared to 2019. North American rail volume for the week ending August 15, on 12 reporting U.S., Canadian and Mexican railroads totaled 315,346 carloads, down 14% compared with the same week last year, and 364,630 intermodal units, down 1% compared with last year. Total combined weekly rail traffic in North America was 679,976 carloads and intermodal units, down 7.5%. North American rail volume for the first 33 weeks of 2020 was 20,729,296 carloads and intermodal units, down 11.3% compared with 2019. Publicly traded companies in the space include CSX (CSX), Canadian National (CNI), Canadian Pacific (CP), Genesee & Wyoming (GWR), Kansas City Southern (KSU), Norfolk Southern (NSC) and Union Pacific (UNP). Reference Link

13:49 EDT Bank of Nova Scotia says fully reserved for $127.5M payment to DOJ, CFTC - Bank of Nova Scotia confirmed that it entered into a deferred prosecution agreement with the U.S. Department of Justice. Additionally, the Commodity Futures Trading Commission issued three separate orders against Scotiabank. The DPA and the orders resolve the DOJ's and CFTC's investigations into Scotiabank's activities and trading practices in the metals markets and related conduct as well as pre-trade mid-market marks and related swap dealer compliance issues, the bank said in a statement. Under the terms of the resolutions, Bank of Nova Scotia agreed to make aggregate payments to the DOJ and CFTC of approximately $127.5M and to retain an independent compliance monitor. The bank said it fully reserved for the payments in the resolutions in prior quarters.

13:32 EDT Amazon announces 11 new sites across Phoenix metro area - Amazon.com announced 11 new sites across the Phoenix metro area expected to be open by the end of 2020 to support customer fulfillment and delivery operations. The new sites are expected to create more than 3,000 new full- and part-time jobs with a minimum $15 per hour wage and comprehensive benefits starting on day one, the company said in a statement. The news follows Amazon's recent announcement of the company's Phoenix Tech Hub expansion at 100 Mill, which will bring more than 500 new jobs to the community. The new sites include seven delivery stations and two additional facilities that support fulfillment operations in Avondale, Chandler, Goodyear, Mesa, Phoenix and Tempe. Amazon's first cross-dock facility in the state is also slated to open by year's end in Phoenix with 1,000 full-time positions. The 600,000 square-foot building will support customer fulfillment by receiving large orders of inventory and redistributing products to fulfillment centers across the company's operations network. Construction is also underway on an 855,000 square-foot fulfillment center in Goodyear, where employees will work alongside Amazon robotics to pick, pack and ship small items to customers such as books, electronics and toys. The site, expected to launch by the end of the year, will create more than 1,000 new full-time jobs.

13:24 EDT Nautilus CEO Jim Barr sells almost $620K in company shares - Nautilus CEO Jim Barr disclosed in a filing that he had sold 44,855 shares of company stock at $13.82 per share between August 17 and August 18, for a total transaction value of $619,681.

13:09 EDT Nintendo Switch to soon be available in Brazil - Nintendo announced via Twitter that its Nintendo Switch line of consoles will be "coming soon" to Brazil. The company did not disclose an official release date in the tweet. Reference Link

12:43 EDT Twitter introduces new Transparency Center - "We have reimagined and rebuilt our biannual Twitter Transparency Report site to become a comprehensive Twitter Transparency Center. Our goal with this evolution is make our transparency reporting more easily understood and accessible to the general public. Twitter added :Brand new website that includes all our disclosed data in one place; Data visualizations making it easier to compare trends over time; Country comparison module; Tooltips to help explain key terms and provide more insights on the terms we use; History of transparency milestones and updates; New metrics and methodology on the enforcement of the Twitter Rules, from July 2018 through December 2019; New policy categories to better align with the Twitter Rules; Reports will be published in Arabic, Turkish, Spanish, German, French, Japanese, and Portuguese very soon too, and we are continuing to iterate on the process to further contextualize the data. Our work to increase transparency efforts across the company is tireless and constant. We will continue to work on increasing awareness and understanding about how our policies work and our practices around content moderation, data disclosures and other critical areas. In addition, we will take every opportunity to highlight the actions of law enforcement, governments, and other organizations that impact Twitter and the people who use our service across the world," said Twitter in a blog posting. Reference Link

12:21 EDT Penn National falls after Barstool's Portnoy says he may have COVID - Shares of Penn National Gaming fell after Barstool Sports founder Dave Portnoy posted on Twitter that he may have COVID-19. Portnoy said in a video that he hasn't gotten out of bed in 40 hours and is very sick. Penn National acquired a 36% interest in Barstool Sports for about $163M in cash and convertible preferred stock in January. After rallying earlier, shares of Penn National are down 1.5% to $54.54 in midday trading. Reference Link

12:17 EDT Enter Air to purchase up to four Boeing 737-8 Jets - Boeing and Enter Air announced the Polish airline is expanding its commitment to the 737 family with a new order for two 737-8 airplanes plus options for two more jets. An all-Boeing operator and Poland's biggest charter carrier, Enter Air began operations in 2010 with a single 737 airplane. Today, the airline's fleet includes 22 Next-Generation 737s and two 737 MAX airplanes. When the new purchase agreement is fully exercised, Enter Air's 737 MAX fleet will rise to 10 aircraft. "Despite the current crisis, it is important to think about the future. To that end, we have agreed to order additional 737-8 aircraft. Following the rigorous checks that the 737 MAX is undergoing, I am convinced it will be the best aircraft in the world for many years to come," said Grzegorz Polaniecki, general director and board member, Enter Air. Enter Air and Boeing have also finalized a settlement to address the commercial impacts stemming from the grounding of the 737 MAX fleet. While the details of the agreement are confidential, the compensation will be provided in a number of forms and staggered over a period of time. "In the settlement with Boeing, we agreed to revise the delivery schedule for the previously-ordered airplanes in response to current market conditions. The specific terms of the settlement are strictly confidential, but we are pleased with the way Boeing has treated us as its customer," added Polaniecki.

12:04 EDT Bank of Nova Scotia pays $127.4M to settle CFTC spoofing charges - The Commodity Futures Trading Commission issued three orders filing and settling charges against Bank of Nova Scotia, a provisionally registered swap dealer, resolving two separate enforcement actions. The combined orders require BNS to pay $127.4M for spoofing and making false statements, as well as for swap dealer compliance and supervision violations and additional false statements. "These record-setting penalties reflect not only our commitment to being tough on those who break the rules, but also the tremendous strides the agency has made in data analytics. Our ability to go through the electronic order book and look across markets has enabled the CFTC to not only spot misconduct, but also to uncover false and misleading statements," said CFTC Chairman Heath P. Tarbert. "Over the last year, we have ushered in a new era of enforcement at the CFTC. Wrongdoers now have increasingly fewer ways to conceal their misconduct and face an even more unified front from civil and criminal authorities." Reference Link

12:00 EDT China Unicom falls -7.7% - China Unicom is down -7.7%, or -64c to $7.63.

12:00 EDT Target rises 11.7% - Target is up 11.7%, or $15.95 to $152.85.

12:00 EDT Hudson rises 46.5% - Hudson is up 46.5%, or $2.38 to $7.51.

11:48 EDT Goodyear announces support for equality, law enforcement amid 'misconceptions' - Goodyear Tire said via Twitter, "Yesterday, Goodyear became the focus of a conversation that created some misconceptions about our policies and our company. Goodyear has always wholeheartedly supported both equality and law enforcement and will continue to do so." Reference Link

11:33 EDT Comscore in active discussions with potential counterparties - Comscore disclosed earlier that it is in active discussions with potential counterparties and expects to conclude these discussions, and announce either its entry into a definitive agreement with respect to a proposed transaction or its decision to continue executing on its strategic plan as an independent company, by its Q3 earnings release. It added, "Throughout this process, the Board and senior management of the Company have been open to engaging with any counterparty as to its potential proposal, whether or not such counterparty intends to retain current directors and executive officers following a transaction. There can be no assurances regarding the timing of any action or transaction or that the strategic review process will result in any particular outcome, and certain transaction alternatives would require the cooperation and approval of Starboard. The Company does not intend to provide additional updates with respect to the foregoing matters unless or until it determines that further disclosure is necessary."

11:26 EDT Northwest Bio reports completion of further data gathering for Phase III trial - Northwest Biotherapeutics announced that the remaining outstanding clinical trial data for the company's Phase 3 trial of DCVax-L for Glioblastoma brain cancer as described in the company's last report on July 24, 2020 has now been completed by the specialty analytics firms. With this data now in hand, final quality control checking and confirmation are under way to enable Data Lock, the company said in a statement. This further data involves specialty analytics such as genomic profiling for IDH mutations and certain imaging. The independent CRO managing the trial is now integrating this data into the overall trial database containing the clinical data from the trial sites that was already complete and locked as reported on July 24, 2020, in order to complete the overall trial dataset. The company currently continues to anticipate reporting topline trial data in September, and anticipates providing further updates as the process progresses.

11:24 EDT TJX sees FY21 CapEx approx. $600M-$800M, up from prior range of $400M-$600M

11:16 EDT TJX expects to be in even better position when environment normalizes

11:10 EDT TJX inventory 'lighter than we would have liked'

11:06 EDT Lowe's launches tool rental program nationwide - Lowe's announced that it will begin rolling out tool rental departments nationwide, creating a one-stop shop for all the tools and equipment Pros and DIY customers need to complete home improvement projects. Lowe's Tool Rental will begin a multi-year national rollout with its first space opening in Charlotte, N.C. on Aug. 20. The tool rental department will feature: A brand-new fleet of commercial-grade equipment, including trusted brands like Husqvarna, Bosch and Metabo HPT; A broad assortment of drain cleaning, restoration, sanitation and concrete tools, in addition to merchandise to accompany rental tools, such as protective equipment and cleaning solutions, for purchase; Technology that enables an easy and convenient check-in and check-out process with an online reservation option, in-store self-service kiosks and digital documents that can be signed and viewed from a mobile device; A dedicated team of knowledgeable associates who can provide hands-on product demonstrations; Approximately 4,000 square feet of space with a fully equipped mechanic shop to service tools, space for on-site cleaning and product demo areas. Lowe's Tool Rental departments will be newly constructed spaces that either expand the Lowe's store or are located on Lowe's property next to an existing store.

10:52 EDT Trump calls for boycott of Goodyear, accuses company of banning MAGA hats - In a tweet, President Donald Trump said, "Don't buy GOODYEAR TIRES - They announced a BAN ON MAGA HATS. Get better tires for far less! (This is what the Radical Left Democrats do. Two can play the same game, and we have to start playing it now!)." Reference Link

10:30 EDT RegeneRx: Enrollment in Phase 3 ARISE-3 trial reaches 600 patients - RegeneRx Biopharmaceuticals said that enrollment in the 700-patient, phase 3 ARISE-3 clinical trial for dry eye syndrome has reached 600 patients, according to GtreeBNT, the company's joint venture partner for development of RGN-259 in the U.S. At this time, due to the COVID-19 virus in the U.S., it is unclear when the trial will finish patient accrual although enrollment continues at a steady pace.

10:05 EDT Net Element CEO updates shareholders on pending merger with Mullen - Net Element issues the following letter to shareholders: "We hope you and your loved ones remain safe and healthy during this COVID pandemic. We continue working diligently on the pending merger with Mullen Technologies and we have taken steps to reduce operating expenses related to our payments processing business as we go through the process contemplated by the Merger Agreement. Since announcing the contemplated merger, we have received a number of inquiries from shareholders requesting clarification regarding the expected number of shares that will be outstanding at closing if the pending merger with Mullen were to be approved. The Merger Agreement provides for a cap of 75 million outstanding shares at the closing of the transaction which cannot be exceeded without both parties' approval; however, this is a maximum number and there is no way of knowing the actual number of shares that will be outstanding at that time. By way of example only, if the share price on the transaction closing date is the same as the closing price on August 18, 2020, the Company anticipates that the number of shares outstanding at closing will be approximately 50 million. If the share price on the transaction closing date is less than the closing price on August 18, 2020, the Company anticipates that the number of shares outstanding at closing will be greater than 50 million but subject to the 75 million share cap. After Mullen's completion and delivery to the Company of its audited financial statements, the Company intends to prepare and file with the SEC a registration statement on Form S-4 in which the proxy statement will be included as a part of the prospectus, in connection with the registration under the Securities Act of the shares of the Company to be issued in connection with the transactions contemplated in the Merger Agreement. Consummation of the merger, the divestiture, the private placement and the other transactions contemplated in the Merger Agreement, are subject to customary conditions including, among others, regulatory approvals and the approval of the Company's stockholders."

09:58 EDT Blonder Tongue Laboratories trading halted, news pending

09:48 EDT CBL rallies 5c to 24c after reaching Restructuring Support Agreement

09:47 EDT OneSmart rises 16.8% - OneSmart is up 16.8%, or 91c to $6.33.

09:47 EDT CBL & Associates enters Restructuring Support Agreement with noteholders - CBL Properties announced that it has entered into a Restructuring Support Agreement with certain beneficial owners and/or investment advisors or managers of discretionary funds, accounts, or other entities representing in excess of 57% of the aggregate principal amount of the Operating Partnership's 5.25% senior unsecured notes due 2023, the Operating Partnership's 4.60% senior unsecured notes due 2024 and the Operating Partnership's 5.95% senior unsecured notes due 2026. The terms of the RSA provide for a restructuring of the company's balance sheet through an in-court process contemplated to commence no later than October 1, 2020. CBL intends to continue negotiations with its senior, secured lenders in the meantime to attempt to reach a consensual arrangement with those lenders. In the event that such an arrangement were reached, the company said it would amend the RSA to include its senior secured lenders. The plan would eliminate the approximately $1.4B principal amount of unsecured notes in exchange for the issuance of $500M of new senior secured notes due June 2028, approximately $50M of cash and approximately 90% of the new common equity of the company to holders of the unsecured notes. As a result, the plan, if implemented, will result in the elimination of approximately $900M of debt, extension of CBL's debt maturity schedule and a reduction in annual interest expense of more than $20M, the company said. The plan also contemplates eliminating the company's more than $600M obligation on its preferred stock in exchange for new common equity and warrants. "In sum, the Plan will provide the Company with a significantly stronger balance sheet by reducing total debt, extending debt maturities and increasing liquidity while minimizing operational disruptions," CBL announced. CBL currently has approximately $220M in cash on hand and available for sale securities, it added.

09:42 EDT CBL & Associates trading resumes

09:31 EDT Lowe's says Q2 Pro sales increased at mid 20% rate - Says urban markets outperformed rural counterparts. Says online sales increased 135% in Q2. Says share buybacks remain suspended. Says August comp sales on par with July's 28% growth.

09:19 EDT Tilt Holdings appoints Dia Simms to board of directors - TILT Holdings announced the appointment of Dia Simms to the Company's Board of Directors. Simms will replace Gary Smith, who is resigning from TILT's board effective this month. Simms spent more than a decade at Combs Enterprises, where she served as President of the company founded by entertainer and entrepreneur Sean Combs.

09:17 EDT Avalon GloboCare enters commercialization, distribution agreement with Cellex - Avalon GloboCare announced that the Company has entered into a commercialization partnership agreement with North Carolina-based Cellex, Inc., whereby Avalon has been awarded distribution rights to market Cellex's COVID-19 antibody-based rapid test kit, which has been granted U.S. FDA Emergency Use Authorization. Avalon is also working with Cellex to source manufacturing facilities and to develop next generation COVID-19 detection kits. This agreement allows Avalon to initiate distribution and marketing of the U.S. FDA EUA registered tests to the Company's designated network of channel partners and distributor affiliates, both in the U.S. and internationally. These rapid test kits are highly accurate and are able to detect IgG and IgM antibodies specific to the SARS-CoV-2 that causes COVID-19 in serum, plasma, and whole blood within 15 minutes.

09:16 EDT Sorrento Therapeutics announces IND filing for COVI-GUARD - Sorrento Therapeutics announced that it is filing an investigational new drug application for COVI-GUARD for hospitalized COVID-19 patients. Sorrento has previously received guidance from the FDA in response to a pre-IND meeting package and believes it has addressed all questions and followed the recommendations from the agency for all sections of the IND. As Sorrento previously announced, in preclinical studies, STI-1499 demonstrated 100% neutralizing effect of the antibody and that a low dose prevented SARS-CoV-2 from infecting healthy cells in such preclinical in vitro studies. Animal data generated by Dr. Paessler's laboratory at the University of Texas Medical Branch at Galveston in Syrian Golden Hamsters infected with SARS-CoV-2, justify the IND filing and continued clinical development. This established model, while limited, is the most predictive animal model currently available for this disease. The data were presented to federal agencies and will be published as soon as possible in a scientific journal. The highest proposed dose in the phase 1 safety trial is a much lower dose than currently being tested for other known antibodies in active clinical studies. The potentially higher potency of the antibody may allow for faster scaled manufacturing and potentially a lower cost per dose as compared to other known antibodies currently being evaluated. STI-1499 antibody has also been evaluated in preclinical studies against multiple strains of SARS-CoV-2, including the highly contagious D614G mutant, the current dominant strain globally. In such preclinical studies, the antibody has been 100% effective against the highly contagious D614G mutant strain at a low dose.

09:13 EDT Muscle Maker opens second ghost kitchen location in Chicago neighborhood - Muscle Maker announced that it has opened its second delivery-only ghost kitchen in the Chicago market. Located at 850 W. Superior St. the kitchen will showcase menus from Muscle Maker Grill, Healthy Joe's and Muscle Maker Grill's new Meal Plan concept - Meal Plan AF. Guests can order 'healthier for you' dishes from any of the three concepts through third party delivery platforms providing ease of ordering and the option for contactless delivery. Ordering platforms include: DoorDash, GrubHub, UberEats, Postmates, ChowNow and Caviar. Demand for delivery is at all time highs due to social distancing and the looming pandemic. Ghost kitchens will allow them to service a broad spectrum of the city's population. The Superior delivery-only ghost kitchen is the second to open out of a ten-location agreement signed by the brand earlier this year. Locations three, four, and five are under construction and will also open in Chicago throughout the summer. The brand has identified a key east coast metropolitan market for the next ghost kitchen market expansion and will be announcing that roll out shortly.

09:12 EDT Hoth Therapeutics provides update on COVID-19 initiatives - Hoth Therapeutics provided an update on its COVID-19 initiatives including vaccine and real-time, breath-based mobile testing device as well as its dermatological therapy pipeline. The BioLexa Platform, Hoth's leading therapy candidate, is a proprietary antimicrobial therapy designed for the treatment of atopic dermatitis or eczema, through a non-corticosteroid approach. Recently, Hoth submitted its planned clinical study for approval of BioLexa treatment of Atopic Dermatitis to the Bellberry Human Research Ethics Committee in Australia. Hoth anticipates to begin the study during the second half of 2020. Hoth recently licensed the intellectual property rights relating to the development of a medical device that has the potential to allow public health professionals to immediately diagnose COVID-19 infection via breath sample and track through a mobile device from the George Washington University. Hoth is working to share further data about the device and determine how few virus particles can be detected using the device to help counteract spread and allow for quicker and more efficient testing and tracing. VaxCelerate is a self-assembling vaccine platform designed to protect patients at risk of COVID-19 infection believed to offer unique advantages over other compounds in combination therapy. Preclinical animal testing of the first construct of VaxCelerate against COVID-19 has commenced. Hoth believes to have results of this animal study and additional next steps in early Q4. Additionally, Hoth has licensed the technology and intellectual property for a novel peptide therapeutic to prevent spike protein binding, which may be a leading cause of COVID-19, and potentially slow its transmission.

09:11 EDT Lowe's says DIY comps outpaced Pro comps in Q2 - Says growth balanced across U.S. in Q2, with strong sales in urban markets. Says "confident" in ability to build on 1H20 momentum into 2H20. Comments taken from Q2 earnings conference call.

08:54 EDT Target sees longer holiday shopping season

08:51 EDT Target: August comps 'off to a great start'

08:47 EDT PepsiCo names Jim Andrew as Chief Sustainability Officer - PepsiCo announced that it has appointed Jim Andrew as Chief Sustainability Officer, in addition to his current role as Executive Vice President, Beyond the Bottle, effective September 1. Andrew replaces Simon Lowden who has decided to retire from PepsiCo after 24 years of exemplary service. In this role, Andrew will be responsible for leading PepsiCo's Sustainability Office, including the Global Sustainable Plastics team and Global Sustainable Operations team.

08:46 EDT Chicken Soup for the Soul adds programming license deals for Crackle Plus - Chicken Soup for the Soul Entertainment announced new programming license deals and new distribution expansion on Xumo for Crackle Plus. Crackle Plus obtained the right to exhibit new content from various license deals through sister company Screen Media. The new license deals include the highly-acclaimed Australian series Metro Sexual from HumDrum Comedy, 11 seasons of the original version of Shameless which was broadcast on Channel 4 in the UK, five seasons of Grounded for Life and Remember the Daze from FilmRise, 99 Homes, The Infiltrator, Knight of Cups, Last Days in the Desert, and Song to Song from Broad Green Pictures, and Kickin' It Old Skool and Doomed! The Untold Story of Roger Corman's the Fantastic Four from Uncork'd. The above titles, alongside existing library titles, bring total Crackle Plus content to approximately 79,000 hours. This includes original and exclusive programming such as Crown Vic, The Clearing, On Point, Going From Broke, '85: The Greatest Team in Football History, Road to Race Day. Cleanin' Up the Town, and Anything is Possible. In addition to increasing its content, Crackle Plus has signed a new distribution deal with Xumo for the Crackle and Popcornflix networks.

08:45 EDT Target: Q2 should not be predictor of long-term performance

08:40 EDT Pareteum receives notification of further listing standards non-compliance - Pareteum received a letter from the Nasdaq Listing Qualifications Staff indicating that the bid price of its listed security had not regained compliance with the $1 per share requirement for continued listing. The Staff determined not to afford the company a second 180-day period and noted that they do not believe it is possible for the company to cure the deficiency, and that the company has not evidenced $5M in stockholders' equity in a recent public filing. In that regard, the company is under a Panel exception dated July 6, which requires the company to file all of its delinquent periodic reports by October 30. The Staff also advised the company that the late filing, which was anticipated in connection with the plan of compliance previously accepted by the Panel, constitutes an additional basis for delisting, as does the bid price issue. The company has been afforded the opportunity to update the Panel on its plan for becoming current in filing prior to the end of the exception period on October 30, and to request additional time for regaining compliance with the bid price requirement and the company intends to do so. Should the company fail to timely regain compliance, trading in its securities would be suspended resulting in trading moving to the OTC market.

08:34 EDT Boxlight, CareHawk enter strategic schooling partnership - Boxlight announced a strategic partnership with CareHawk, based in Ontario, Canada. The strategic partnership will integrate the Life Safety products of CareHawk, as a supplemental solution to Boxlight's MimioClarity classroom audio solution. The combined solution will provide district communications and classroom audio products and will allow for integrated safe schools initiatives.

08:33 EDT Taoping announces 15 new members for Taoping Alliance - Taoping announced that 15 companies have joined the Taoping Alliance to operate Taoping new media in 15 cities as its city partners. As of now, Taoping Alliance has 211 domestic members operating in 211 cities across 26 provinces out of 34 provincial-level administrative units in China as well as three overseas members. The 15 new members are Yiliang Taoping and Shilin Taoping in Yunnan Province, Renhuai Taoping, Tongren Taoping, Longli Taoping, Sansui Taoping, Jianhe Taoping, Taijiang Taoping, Huangping Taoping, Zhenyuan Taoping, Majiang Taoping and Danzhai Taoping in Guizhou Province, Yueyang Taoping in Hunan Province, Yingshan Taoping in Hubei Province, Wanzhou Taoping in Chongqing Municipality. The 15 companies are purchasing smart display screens from TAOP and are responsible for new media and online retail operations at Yiliang County, Shilin Yi Autonomous County, Renhuai City, Tongren City, Longli County, Sansui County, Jianhe County, Taijiang County, Huangping County, Zhenyuan County, Majiang County, Danzhai County, Yueyang City, Yingshan County, Wanzhou District respectively.

08:32 EDT Monopar, NorthStar partner with Aragen for testing therapeutic for COVID-19 - Monopar Therapeutics and NorthStar Medical Radioisotopesannounced a partnership with Aragen Bioscience. Aragen will perform studies aimed at selecting a lead candidate uPRIT to advance into IND-enabling development for severe COVID-19. The aim of this partnership is to identify the uPRIT with the optimal urokinase plasminogen activator receptor binding profile, enabling selective delivery of a cytotoxic radioisotope to just those aberrantly activated immune cells that produce the "cytokine storm" that causes severe lung injury, multiple organ damage, and death in severe COVID-19 patients.

08:19 EDT Teva Canada announces product availability of Ajovy 225 mg solution - Teva Canada, a subsidiary of Teva, announced product availability of Ajovy 225 mg solution for subcutaneous injection for the preventive treatment of migraine in adults who have at least four migraine days per month. Ajovy is the first and only anti-CGRP drug approved in Canada, the European Union and the United States that offers quarterly or monthly dosing regimens for the preventive treatment of migraine. The quarterly dose of 675 mg is given as three 225 mg subcutaneous injections once every three months; the monthly dose of 225 mg is given as one subcutaneous injection once each month. Ajovy is currently available in a latex-free prefilled syringe.

08:18 EDT Target to adjust candy merchandising for Halloween, sees less trick-or-treating

08:17 EDT eHealth announces resignation of COO David Francis - eHealth disclosed last night that on August 14, David Francis resigned from his positions as Chief Operating Officer, effective as of August 31.

08:15 EDT Target guests still want to celebrate seasons, holidays despite COVID, says CEO

08:14 EDT Pack4U selects SinfoniaRx for clinical telepharmacy services - Tabula Rasa HealthCare announced an agreement to deliver clinical telepharmacy services for Pack4U. A personalized medication delivery company, Pack4U uses a digital pharmacy network to drive patient-centric care. This new partnership will provide an integrated platform for comprehensive medication management and safety, keeping patients safe at home. Pack4U's enhanced medication adherence program, "Connected Care at Home," brings together technology and pharmacy networks. Its direct-to-patient device integrates in-home medication dispensing and real-time patient feedback to provide data-driven insights for improved patient outcomes. TRHC's clinical telepharmacy services will provide medication monitoring for adherence and coordination with providers to optimize clinical results. With the addition of TRHC's data science, analytics, and expertise, Pack4U offers a complete package to health plans for improving quality metrics, including Star Ratings and HEDIS measures.

08:12 EDT Southwest sees Q3 capacity down 30%-35% vs. prior estimate of 20%-30% drop - In a regulatory filing, Southwest stated, "The Company continues to experience significant negative impacts to passenger demand and bookings in third quarter 2020 due to the COVID-19 pandemic. As previously disclosed, the Company was encouraged by improvements in May and June 2020 leisure passenger traffic trends, compared with March and April 2020; however, the improving trends in revenue and bookings stalled in early July 2020, and remained depressed for the remainder of the month, due to the rise in COVID-19 cases. Thus far in August 2020, the Company has experienced a modest improvement in close-in leisure passenger demand. However, year-over-year revenue declines remain significant, and passenger demand and booking trends remain inconsistent, which guided the Company's recent reduction of available seat miles in August, September, and October published flight schedules. The Company's preliminary July 2020 operating revenues decreased, year-over-year, in the range of 70 to 75 percent; capacity decreased approximately 31 percent, year-over-year; and load factor was approximately 43 percent; all in line with the Company's previous estimations. Based on modest improvements in close-in leisure passenger demand, the Company now estimates August 2020 operating revenues to decrease, year-over-year, in the range of 70 to 75 percent; capacity to decrease approximately 27 percent, year-over-year; and load factor to be in the range of 40 to 45 percent. The Company's revenue and load factor outlook compares favorably with its previous estimations of August 2020 operating revenues decreasing, year-over-year, in the range of 70 to 80 percent, and load factor in the range of 30 to 40 percent. The Company's previous guidance for August 2020 capacity was a decrease of approximately 20 percent, year-over-year. The Company's booking trends have also modestly improved for September 2020, with operating revenues estimated to decrease, year-over-year, in the range of 65 to 75 percent. Based on recent capacity reductions, the Company now estimates its September 2020 capacity to decrease approximately 40 percent, year-over-year, compared with its previous estimation of a year-over-year decrease in the range of 20 to 25 percent, and estimates load factor to be in the range of 40 to 50 percent. The Company now estimates third quarter 2020 capacity to decrease in the range of 30 to 35 percent, year-over-year, compared with its previous estimation of a year-over-year decrease in the range of 20 to 30 percent. The Company estimates its October 2020 capacity to decrease in the range of 40 to 50 percent, year-over-year. The Company recently published its flight schedule for sale through April 11, 2021, and continues to plan for multiple scenarios for its fleet and capacity plans given the uncertain revenue environment. The Company will continue to monitor demand and booking trends and adjust monthly capacity, as deemed necessary, on an ongoing basis. As such, the Company's actual flown capacity may differ materially from currently published flight schedules. To support physical-distancing, the Company is currently limiting the number of seats sold on each flight to allow for middle seats to remain open for Customers who are not traveling together through at least October 31, 2020. Based on the Company's existing fuel derivative contracts and market prices as of August 13, 2020, the Company continues to estimate its third quarter 2020 economic fuel costs to be in the range of $1.20 to $1.30 per gallon, including $24 million, or $.08 per gallon, in premium expense and no cash settlements from fuel derivative contracts. The Company continues to expect third quarter 2020 operating expenses, excluding fuel and oil expense, special items, and profit sharing expense, to decrease in the range of 10 to 20 percent, year-over-year. The Company's preliminary average core cash burn in July 2020 was approximately $17 million per day, slightly better than its previous estimation of approximately $18 million per day. The Company now estimates its average core cash burn to be approximately $20 million per day in third quarter 2020. This compares favorably with the Company's previous estimate of third quarter 2020 average daily core cash burn of approximately $23 million, primarily due to recent, modest improvements in revenue trends."

08:10 EDT Biocept expands agreement with MultiPlan to include COVID-19 testing - Biocept announces the expansion of its agreement with MultiPlan to include COVID-19 testing services at a pre-negotiated price per test. MultiPlan is a healthcare cost management company offering payment integrity, network-based and analytics-based services. With the expanded agreement, Biocept's COVID-19 testing, in addition to its liquid biopsy oncology testing services, are now accessible to consumers who have access to the PHCS and MultiPlan Networks, MultiPlan's national primary and complementary networks. More than 1 million healthcare providers participate in MultiPlan's networks and 60 million health plan members have access to the company's services.

08:08 EDT Vocera acquires EASE Applications, issues 60,000 shares to its employees - Vocera announced that it has acquired EASE Applications, based in Orlando, Florida. EASE offers a cloud-based communication platform and mobile application built to improve the patient experience by enabling friends and family members to receive timely updates about the progress of their loved one in the hospital. The EASE app enables nurses and other care team members to send HIPAA-compliant texts, photos and video updates to patients' loved ones, putting them at ease and saving valuable time. With more than 1.6M sent messages, the EASE application has demonstrated improved patient and family satisfaction and reduced the number of phone calls from loved ones to the hospital. In one study with approximately 2,500 family members, 98% said that EASE reduced their anxiety, and 81% reported that the availability of EASE would influence their choice of hospital. Additionally, patient satisfaction scores increased by an average of 6% for patients who used EASE compared to patients who did not use the application. As part of the onboarding process, Vocera will issue restricted stock units totaling approximately 60,000 shares of Vocera common stock to approximately eleven employees of EASE. These restricted stock units will vest over three years after the closing and will be made from an inducement plan adopted by the company's board of directors pursuant to the inducement exemption provided under the NYSE listing rules.

08:08 EDT Target CEO: American consumers adopting digital shopping 'like never before'

08:06 EDT Bio-Techne and Leica Biosystems partner for COVID-19 research platform - Bio-Techne, in partnership with Leica Biosystems, announced the automation of RNAscope COVID-19 probes on BOND RX, Leica's staining platform, for research use only. Researchers now have the ability to automate their COVID-19 research protocols, reducing manual labor and turnaround time. The BOND RX is an open platform with the capability to run Bio-Techne RNAscope protocols, allowing for boundless innovation. The RNAscope probes are designed to detect SARS-Cov-2 viral RNA, SARS-Cov-2 viral replication sequences, and cellular receptors targeted by the virus, including ACE2 and TMPRSS2.

08:06 EDT Target results 'exceptional by virtually any measure,' CEO Brian Cornell says - Comments taken from Q2 earnings conference call.

08:03 EDT Ampio updates Ampion clinical trials for COVID-19 treatment - Ampio provided updates regarding COVID-19 clinical trials: on the Ampion Phase I clinical trial for intravenous treatment of COVID-19 patients, the initial safety assessments are complete and the trial is cleared to enroll the remaining patients for the Phase I US based clinical trial evaluating a 5-day IV Ampion treatment for COVID-19 patients requiring supplemental oxygen. The results, reviewed by an independent Safety Monitoring Committee, found Ampion to be safe and well-tolerated, and authorized the trial to move to completion. Regarding the Ampion IND application for inhalation treatment of COVID-19 patients, independent toxicologists found no evidence of toxicity in preclinical trials, and this extensive data has been submitted to the FDA. A clinical trial protocol for treating patients who have respiratory distress due to COVID-19 with nebulized Ampion has already been submitted and is being reviewed by the FDA.

08:01 EDT Rockwell Automation names Rebecca House chief administrative, legal officer - Rockwell Automation (ROK) has named Rebecca House to the expanded leadership role of senior VP and chief administrative and legal officer, effective immediately. In this newly created role, she is responsible for accelerating the evolution of Rockwell Automation's culture and leading the company's human resources and talent teams in addition to her existing responsibilities overseeing the company's legal, ethics and compliance, global security, public affairs, and environmental, health and safety teams. House, who previously served as CLO, reports directly to Blake Moret, Rockwell automation chairman and CEO, and leads a team of more than 500. Before coming to Rockwell Automation, House served as assistant general counsel and assistant board secretary at Harley-Davidson (HOG). Earlier in her career, she was a partner at Foley & Lardner in Milwaukee.

07:58 EDT TJX reports total inventories as of August 1 were $3.7B - Total inventories as of August 1 were $3.7B, compared with $5.1B at the end of Q2 last year. The year-over-year decline in balance sheet inventory was due to a combination of factors. These included lower planned store inventory levels in Q2 primarily to promote social distancing for associates and customers, stronger than expected sales as stores reopened and supply chain and logistics challenges at the company and some of its third-party affiliates as operations ramped up.

07:55 EDT CBL & Associates trading halted, news pending

07:50 EDT Teligent anticipates return to cash flow positive in 1Q21 - The First Lien Amendment and the Second Lien Amendment amend the First Lien Credit Agreement and Second Lien Credit Agreement, respectively, to decrease the required minimum Liquidity of the Company and its subsidiaries, on a consolidated basis, to $3.0 million. The Company anticipates being in compliance with the minimum Liquidity covenant at and as of December 31, 2020. The Company anticipates that it will return to being cash flow positive in the first quarter of 2021.

07:49 EDT Teligent says FDA deemed responses to Warning Letter as 'inadequate' - On August 13, 2020, the Company received an additional comment letter from the FDA relating to the Company's response to the Warning Letter issued in November 2019. The comment letter indicated that the FDA reviewed the Company's responses and deemed them to be inadequate as the Company failed to address and/or provide supporting documentation to several of the concerns raised in the Warning Letter. President & CEO Timothy Sawyer stated, "This news is both disappointing and unexpected. However, the letter is not an indication of further imminent action on the FDA's part, but the opportunity for Teligent to make further improvements and provide additional responses and supporting documentation to the FDA prior to their coming in for an inspection." The Company is targeting a written response to the FDA's most recent correspondence in mid-September 2020.

07:42 EDT FormFactor sees $50M-$60M in capacity expansion in 2020 - Under its longer-term Target CapEx Model, the company targets CapEx of $30M-$50M, revenue rising to $850M, and gross margins expanding to 47.0% from 45.9% seen in the first half of 2020. Comments taken from yesterday's Analyst Day investor presentation slides.

07:28 EDT Medipharm Labs Australia receives amendment to GMP license - MediPharm Labs announced that its Australian operation, MediPharm Labs Australia, has received an important enabling amendment to its Good Manufacturing Practice Certification and License to Manufacture Therapeutic Goods. The license expansion, granted under Section 40B of the Australian Therapeutic Goods Act 1989 by the Therapeutic Goods Administration of the Australian Government's Department of Health, provides MediPharm Labs with the ability to manufacture Active Pharmaceutical Ingredient derived from cannabis and cannabis intermediates - such as resins, extracts and isolates - as well as medicinal cannabis finished products including oral liquids, soft-gel capsules and oil. This is one of very few licenses of its kind for dedicated medicinal cannabis manufacture in Australia. MediPharm Labs Australia is poised to service the entire Australian patient population. July was a record month in Australia with over 5560 SAS-B medical cannabis approvals, an increase of 20% from June. As of 31 July 2020, the TGA approved over 56,000 SAS Category B applications for unapproved medicinal cannabis products. At current levels, MediPharm Labs anticipates more than 70,000 patient approvals could be achieved by the end of 2020. Under the updated license, MediPharm Labs may manufacture medicinal cannabis finished therapeutic goods intended for: registration in Australia; Clinical Trial use; and products for export or which are exempt from registration and listing on the Australian Register of Therapeutic Goods under the provisions of Section 18(1) or Section 19 (1)(a) of the Therapeutic Goods Act. MediPharm Labs Australia may also manufacture API intended for Further Manufacture by other licensed manufacturers.

07:24 EDT Onex appoints Bobby Le Blanc as president, Anthony Munk as vice chairman - Onex Corporation announced the promotion of Bobby Le Blanc to President of Onex. Le Blanc will oversee all of Onex' business units and become the sole Head of Onex Partners, the firm's flagship private equity strategy. Mr. Le Blanc's appointment reflects his decades-long commitment to Onex, his strong reputation among his peers, and his talent as a successful investor with a proven track record of managing teams and driving value creation. Gerry Schwartz will remain Chairman and CEO, with Bobby reporting to him. As part of this leadership change, Anthony Munk will become Vice Chairman of Onex, providing investment advice across the firm and particularly at Onex Partners, as Chair of its Investment Committee. Finally, Seth Mersky will step back from his broader role at Onex and become Vice Chairman of Gluskin Sheff.

07:22 EDT Akoustis anoounces 6.5 GHz XBAW filter for WiFi 6E - Akoustis Technologies announced it introduced an ultra-wideband 6.5 GHz XBAW filter that covers the entire U-NII-5 to U-NII-8 bands of the new WiFi 6E unlicensed spectrum. When paired with the Company's 5.5 GHz XBAW filter announced in early June, Akoustis can now provide the industry's first complete BAW-based micro filter solution for the emerging WiFi 6E standard. The Company expects to announce sampling later this quarter and to have fully qualified 5.5 and 6.5 GHz XBAWTM filters by early calendar 2021. The potential market for the Company's WiFi 6E filter solutions include dual-band to quad-band CPE WiFi routers as well as mobile handsets, laptops, tablets, and gaming devices as our wafer-level-packaging is completed later this year.

07:19 EDT Anavex announces commitment for investment by Shake It Up Foundation - Anavex Life Sciences announced that the Shake It Up Foundation for Parkinson's Research and its international partners has committed to invest into Anavex up to 50% of the costs of a disease modifying clinical study to develop ANAVEX 2-73 for the disease modifying treatment of Parkinson's disease. The planned clinical study will use a convenient, once-daily oral ANAVEX 2-73 formulation to confirm the previously established potential disease modifying features of ANAVEX 2-73 in an animal model of Parkinson's disease. Safety and efficacy will be investigated in an appropriately powered placebo-controlled clinical study of Parkinson's disease patients over at least 48-weeks including ANAVEX 2-73-specific precision medicine biomarkers. All patients who participate in the study will be eligible to receive ANAVEX 2-73 under a voluntary open label extension protocol.

07:16 EDT Turning Point Therapeutics announces FDA feedback on TRIDENT-1 trial design - Turning Point announced recent feedback received from the FDA and modifications the company is making to the study design that may accelerate the timelines to potential approval for repotrectinib. The FDA reiterated that the adequacy of the data to support approval will depend upon the observed ORR and the duration of response assessed in the context of available therapy in a risk-benefit analysis during NDA review. These updates include: Phase 2 cohort sample sizes to support potential approval may include Phase 1 patients treated at the recommended Phase 2 dose. The pooling of Phase 1 and Phase 2 data may shorten timelines to potential regulatory submission based on fewer patients from the Phase 2 portion of the study. EXP-2 Cohort: The company plans to decrease the sample size from current target of 100 patients to 60 total patients with one formal interim analysis after approximately 30 patients. FDA provided guidance that 6 months of follow up may be sufficient to support approval. EXP-4 Cohort: The company plans to increase the sample size to a target of 60 patients with one formal interim analysis after approximately 30 patients. Previously, EXP-4 was an exploratory cohort in this patient population. FDA provided guidance that 6 months of follow up may be sufficient to support approval. EXP-5 and EXP-6 Cohorts: FDA provided guidance that 9 months and 6 months of follow up, respectively, from the last response may be sufficient to support approval. Previous guidance was 12 months for both patient cohorts. Based on this FDA feedback and the subsequent sample size changes, the company is reviewing its timelines for when it expects the top-line interim analysis data sets will be achieved, and anticipates sharing those timelines as it gets closer to achieving full site activation in early 2021.

07:12 EDT Nemaura Medical issues presentation on CGM being used by COVID-19 patients - Nemaura Medical issued a presentation outlining how continuous glucose monitoring, or CGM, is being used by quarantined and hospitalized COVID-19 patients. The company has previously reported the uses of continuous lactate measurements for the monitoring of diseases progression in COVID-19 patients. The company issued a report outlining how CGM has been used as an effective tool for the monitoring of disease progression in both quarantined and hospitalized COVID-19 patients. This includes improvement in glycaemic control in persons with Type 2 diabetes, monitoring and managing hyperglycaemia in patients with COVID-19, and remote monitoring of glucose levels in hospitalized COVID-19 patients leading to improved quality of care without compromising the safety of medical professionals. Both the CGM and CLM, or continuous lactate monitoring, products are based on Nemaura's BEAT platform, which is designed to non-invasively extract a number of analytes through the skin. By adapting the sensor chemistry, algorithm and mobile app interface initially developed for sugarBEAT, the BEAT platform has the potential to be utilized for several markets beyond glucose monitoring and diabetes. Nemaura is evaluating the timelines for bringing the CLM to market as a Class 2 approved Medical Device, and the CGM device is a CE mark approved Class 2b medical device planned for launch this calendar year in the UK and Germany.

07:09 EDT Kamada, Kedrion report KEDRAB pediatric trial meets primary objective - Kamada and Kedrion Biopharma announced results from a U.S. post-marketing pediatric trial of KEDRAB. The study represents the first and only trial of a currently available human rabies immune globulin conducted in children in the U.S. to date. The results have been submitted to the U.S. Food and Drug Administration for review and inclusion as pediatric data in the KEDRAB full prescribing information. KEDRAB is a human rabies immunoglobulin indicated for passive, transient post-exposure prophylaxis treatment of rabies infection, when given promptly after contact with a rabid or possibly rabid animal. The KEDRAB U.S. Pediatric Trial was conducted at two sites, one in Arkansas and another in Rhode Island. The study included 30 pediatric patients, each of whom received KEDRAB as part of PEP treatment following exposure or suspected exposure to an animal suspected or confirmed to be rabid, and safety follow-up was conducted for up to 84 days. The primary objective of the study was to confirm the safety of KEDRAB in the pediatric population. Secondary objectives included the evaluation of antibody levels and the efficacy of KEDRAB in the prevention of rabies disease when administered with a rabies vaccine according to the PEP recommended guidelines. No serious adverse events were observed during the study. No incidence of rabies disease or deaths were recorded throughout the 84-day study period. KEDRAB was launched in the U.S. in April 2018 and generated in-market sales of $31M in 2019, representing approximately 20 percent of the U.S. HRIG market.

07:07 EDT TD Holdings entering digital cloud storage business - TD Holdings is establishing a wholly-owned subsidiary Tongdow Data Technology in Hainan Province, China, for the development and operation of a digital cloud storage for commodities trading business. The digital cloud storage business will aim to solve the problems of shortage of funds and risk management of financial institutions, as well as enhance the security of physical transactions and delivery of commodities.

07:06 EDT PolyPid expects cash to fund operations through 2H22 - As of June 30, 2020, the Company had cash and cash equivalents, restricted cash and short-term deposits in amount of $81.7M, compared to $27M at December 31, 2019. This reflects the completion of the Company's IPO in June 2020, which raised net proceeds of $62.8M, after underwriting fees and offering expenses. PolyPid expects this cash balance is sufficient to fund operations through the second half of 2022.

07:04 EDT BioLineRx achieves enrollment target in Phase 3 GENESIS trial - BioLineRx announced that a sufficient number of patients (~65% of the original planned sample size) have been enrolled in the ongoing GENESIS Phase 3 trial to allow for an interim efficacy analysis to take place in the second half of 2020. This ongoing registrational study is investigating motixafortide (BL-8040) for the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma. If the primary endpoint is met at the time of the interim analysis, the company plans to immediately announce the cessation of further recruitment, without the need to enroll the full planned sample size. In this case, top-line results are expected in the first half of 2021, in order to maintain study blinding for all study endpoints, including those related to engraftment, for a period of 100 days subsequent to transplantation. If the primary endpoint is not reached in the interim analysis, the company expects recruitment will continue until the originally planned sample size is met

07:03 EDT Gan Limited signs binding agreement with LDC to supply simulated gaming software - Gan Limited announced the signing of a binding agreement with Laguna Development, or LDC, to supply its simulated gaming software to the client's Route 66 Casino property located just outside of Albuquerque, New Mexico, with new services anticipated to launch to customers in Q3. LDC owns and operates the Route 66 Casino Hotel and Dancing Eagle Casino in New Mexico. Route 66 Casino features a gaming floor with over 1,700 slot and video poker machines, 26 table games, a 500-seat bingo hall, and a dedicated poker room with 10 tables. The agreement with GAN will enable the client to provide an expanded suite of online gaming and services throughout the region and beyond. The agreement also provides Gan with the opportunity to supply online sports wagering to LDC in New Mexico, should enabling legislation and corresponding regulatory approvals come to pass.

07:01 EDT Accenture wins position on AIr Force strategic transformation contract - Accenture subsidiary Accenture Federal Services is one of eight firms awarded a position on a contract to help the U.S. Air Force manage and execute enterprise-wide transformation efforts. The indefinite delivery/indefinite quantity contract has a five-year ordering period, with a maximum value of $990M and was awarded by Air Force District of Washington, Secretary of the Air Force Enterprise Support Division for the Deputy Under Secretary of the Air Force, Management and Deputy Chief Management Office. The services that Accenture would provide include digital solutions, the alignment of organizational models, and data-driven performance management across up to 10 Department of Defense lines of business: contract/category management; financial management; information technology; acquisition/logistics/supply chain; healthcare; community services; human resources; real property; digital transformation; and the DoD 4th Estate.

06:51 EDT Fastenal, Hockey League announce multiyear global partnership - Fastenal and the National Hockey League announced a multiyear global partnership, naming Fastenal the official Maintenance, Repair and Operations partner of the NHL through the 2023-24 season. The partnership is focused on creating an efficient and reliable MRO supply chain for ice rinks across North America.

06:46 EDT Galapagos sinks after FDA issues Complete Response Letter to partner Gilead - Galapagos (GLPG) last night announced that Gilead Sciences (GILD) received a Complete Response Letter from the Food and Drug Administration for the New Drug Application for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis. Gilead is the market authorization holder for filgotinib in the United States and is responsible for potential commercialization in the U.S., the company said in a statement. The FDA has requested data from the MANTA and MANTA-RAy studies before completing its review of the NDA. The FDA also has expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose, Galapagos notes. "This CRL issued by the FDA is very disappointing given the robust and comprehensive data package provided. Despite today's news, we continue to believe filgotinib has the potential to provide an effective, new treatment option for patients with rheumatoid arthritis, where there remains a significant unmet need," said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos. Under the terms of the agreement with Gilead, Galapagos is entitled to an approval milestone of $100M for the approval of filgotinib in the U.S., which was included in the Galapagos cash burn guidance. Following this CRL, Galapagos revises its full year 2020 operational cash burn guidance to between EUR 490M and EUR 520M. Shares of Galapagos are down 29%, or $55.45, to $132.63 in premarket trading.

06:37 EDT Target reports Q2 digital comparable sales grew 195% - The company said digital accounted for 13.4 percentage points of its comparable sales growth of 24.3%. Target also reported stores fulfilled more than 90% of Q2 sales. Reports same-day services grew 273% and accounted for approximately six percentage points of total company comparable sales growth.

06:36 EDT Johnson & Johnson to acquire Momenta Pharmaceuticals for $6.5B or $52.50/shr - Johnson & Johnson (JNJ )announced it has entered into a definitive agreement to acquire Momenta Pharmaceuticals (MNTA) in an all cash transaction for approximately $6.5 billion. The transaction will include full global rights to nipocalimab (M281), a clinically validated, potentially best-in-class anti-FcRn antibody. Nipocalimab gives Janssen the "opportunity to reach significantly more patients by pursuing indications across many autoimmune diseases with substantial unmet medical need in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology and autoimmune hematology. Nipocalimab recently received a rare pediatric disease designation from the U.S. Food and Drug Administration. Momenta's expertise in FcRn mechanisms is especially important for nipocalimab as it supports and accelerates the development of a medicine designed to target a number of autoantibody-driven conditions across several of Janssen's established therapeutic areas. Janssen expects nipocalimab to contribute to its goals of achieving above-market growth over the mid and long term." In addition to Momenta's employees and lead asset nipocalimab, Janssen will acquire Momenta's pipeline of clinical and pre-clinical assets. Under the terms of the transaction, which was approved by the Boards of Directors of both companies, Vigor Sub, Inc. (Merger Sub), a newly formed wholly-owned subsidiary of Johnson & Johnson (the Company), will commence a tender offer to purchase all outstanding shares of Momenta for $52.50 per share. The closing of the offer is conditioned on the tender of a majority of the outstanding shares of Momenta's common stock on a fully diluted basis, as well as clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. The merger will be effected as soon as practicable after the closing of the tender offer. The transaction is expected to close in the second half of 2020. While the closing of the transaction is expected to be modestly dilutive, the Company is maintaining its current 2020 Adjusted EPSi guidance range. Looking ahead, the costs associated with the development of Momenta's portfolio are expected to be incremental to planned R&D investment levels over the next few years given the value creation potential of our current portfolio, and thus expect this incremental investment in R&D to have an EPS impact worth approximately 10c-15c in 2021.

06:31 EDT Johnson & Johnson to acquire Momenta Pharmaceuticals for $6.5B

06:11 EDT Pluralsight partners with U.S. Air Fore for Digital U technology skills program - Pluralsight is partnering with the U.S. Air Force to power its Digital U learning program. The Air Force's Digital U program is designed to help Airmen across the service develop skills in core technology topics such as software development, artificial intelligence/machine learning, and cybersecurity. Airmen have access to more than 7,000 courses in a variety of technical areas. With Pluralsight, Air Force Digital U participants have access to more than 7,000 technology courses taught by experts.

06:07 EDT United States Oil Fund gets Wells Notice from SEC - In a regulatory filing, U.S. Oil Fund said that on August 17, United States Commodity Fund LLC, United States Oil Fund LP and John Love received a "Wells Notice" from the staff of the U.S. Securities and Exchange Commission. The Wells Notice relates to USO's disclosures in late April and early May regarding constraints imposed on USO's ability to invest in Oil Futures Contracts. The Wells Notice states that the SEC staff has made a preliminary determination to recommend that the SEC file an enforcement action against USCF, USO, and Love alleging violations of Sections 17(a)(1) and 17(a)(3) of the Securities Act of 1933, as amended, and Section 10(b) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, in each case with respect to its disclosures and USO's actions during that period. A Wells Notice is neither a formal charge of wrongdoing nor a final determination that the recipient has violated any law. USCF, USO, and Love maintain that USO's disclosures and their actions were appropriate. They intend to vigorously contest the allegations made by the SEC staff in the Wells Notice and expect to engage in a dialogue with the SEC staff regarding this matter.

06:03 EDT Sunnova Energy, GAF Energy announce partnership - GAF Energy, a provider of roof-integrated solar solutions in North America, and Sunnova Energy announced a strategic partnership to provide homeowners with GAF Energy's DecoTech 2.0 solar roofing system together with Sunnova's solar service offerings. The partnership leverages both companies' reach in the new home and re-roof markets and exemplifies the growing convergence between roofing and solar.

05:59 EDT Dr. Reddy's announces launch of AVIGAN tablets in India - Dr. Reddy's announced the launch of AVIGAN 200 mg Tablets in India. The launch is part of the global licensing agreement with FUJIFILM Toyama Chemical Co. Ltd. that grants Dr. Reddy's the exclusive rights to manufacture, sell and distribute AVIGAN 200 mg Tablets in India. AVIGAN has been approved by the Drugs Controller General of India for the treatment of patients with mild to moderate COVID-19 disease.

05:52 EDT Regeneron, Roche partner to develop, distribute REGN-COV2 - Regeneron (REGN) and Roche (RHHBY) announced that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute REGN-COV2, Regeneron's investigational anti-viral antibody cocktail, to people around the globe. REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic. This collaboration is expected to increase supply of REGN-COV2 to at least three and a half times the current capacity, with the potential for even further expansion. REGN-COV2 is currently being studied in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S. Under the terms of the agreement, each company has committed to dedicate a certain manufacturing capacity to REGN-COV2 each year, and the collaborators have already begun the technology transfer process. Each company will bear its own distribution expenses in their designated territories. The collaborators will jointly fund and execute the ongoing Phase 3 prevention and Phase 1 healthy volunteer safety studies, as well as any additional global studies to evaluate further the potential for REGN-COV2 in treating or preventing COVID-19. Roche will be primarily responsible for securing regulatory approvals outside the U.S., following the initial European Medicines Agency approval, and conducting any additional studies specifically required for approval by regulators outside the U.S.