Stockwinners Market Radar for June 12, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:25 EDT NuCana says FDA grants orphan drug designation for Acelarin - NuCana announced that the U.S. Food and Drug Administration has granted orphan drug designation for the Company's investigational drug, Acelarin, for the treatment of biliary tract cancer. Acelarin is a new chemical entity and is NuCana's ProTide transformation of gemcitabine. "We are pleased to have received orphan drug designation from the FDA for Acelarin in biliary tract cancer," said Hugh Griffith, NuCana's Founder and Chief Executive Officer. "There is a high unmet need for patients suffering from this cancer type. Our Phase Ib study of Acelarin combined with cisplatin showed an approximate doubling of the response rate expected with the standard of care, gemcitabine plus cisplatin, with several patients achieving significant reductions in their tumor volume as well as further tumor shrinkage over time. We believe Acelarin represents a potential significant advance in biliary tract cancer and we remain on track to open our global Phase III study in combination with cisplatin as a front-line treatment for patients with advanced biliary tract cancer in 2019."

19:03 EDT Gree switches to Rimini Street support for SAP applications - Rimini Street announced that Japan's GREE, Inc has switched to Rimini Street support for its SAP ECC 6.0 system. GREE has been using its SAP system for nearly six years and was satisfied with their current mature ERP environment, however a 2025 planned end of mainstream maintenance date for ECC 6, and high operations and maintenance costs from the vendor became an issue.

18:35 EDT Stockland targets FY19 FFO growth of about 5% - Sees FY19 settlements of about 5,900 amid production delays at Mt Atkinson. Says: "Following challenging market conditions, sales rates remain low, expected to result in 4Q19 net sales around 700 lots." Comments from the company's annual investor day.

18:02 EDT AbbVie says patients show improved RA symptoms in upadacitinib trials - AbbVie announced new results from the Phase 3 clinical trials SELECT-EARLY and SELECT-COMPARE showing that patients receiving upadacitinib once-daily through 48 weeks continue to demonstrate improved signs and symptoms of rheumatoid arthritis, as measured by ACR20/50, and clinical remission based on Disease Activity Score 28 C-Reactive Protein less than2.6. The studies evaluate upadacitinib, an investigational, once-daily JAK1-selective inhibitor, in patients with moderately to severely active rheumatoid arthritis. Additionally, data from an integrated safety analysis across five Phase 3 SELECT clinical trials show that treatment with upadacitinib in patients with moderately to severely active rheumatoid arthritis demonstrates a consistent safety profile. These results are being presented at the European League Against Rheumatism Annual European Congress of Rheumatology, June 12-15, in Madrid. "These data continue to support the potential of upadacitinib to help maintain consistent disease control for patients living with moderately to severely active rheumatoid arthritis," said Professor Ronald van Vollenhoven, M.D., Ph.D., Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands. "While remission is the primary treatment goal, in accordance with the American College of Rheumatology and the European League Against Rheumatism recommendations, a majority of patients do not achieve clinical remission today, despite currently available treatment options."

17:29 EDT Made by Google tweets photo confirming new Pixel 4 phone - Reference Link

17:15 EDT Huntington Ingalls awarded $687.09M Navy contract for work on USS Gerald R. Ford - Huntington Ingalls has been awarded a maximum-value $687.09M cost and cost-plus-fixed-fee, indefinite-delivery/indefinite-quantity contract for early service life period work on USS Gerald R. Ford. The purpose of this contract is to support ship repair and modernization during continuous incremental availabilities, planned incremental availabilities, full-ship shock trials and continuous maintenance and emergent maintenance during the ship's early service life period. This contract includes five ordering periods totaling 60 months, with a maximum order value of $687.09M. Work for the initial delivery order will be performed in Newport News, Virginia and is expected to be completed by June 2020. Work under all five delivery orders is expected to be completed by June 2024. FY19 operation and maintenance funding in the amount of $1.72M will be obligated at time of award and will expire at the end of the current fiscal year. This contract was not competitively procured in accordance with 10 U.S. Code 2304, only one responsible source and no other supplies or services will satisfy agency requirements. The Naval Sea Systems Command is the contracting activity.

17:11 EDT PolarityTE director Gorlin sells 53.7K shares of common stock - In a regulatory filing, PolarityTE disclosed that its director Steve Gorlin solid 53.7K shares of common stock on June 10th. The total transaction size was $319K.

17:06 EDT Destination Maternity to conduct comprehensive review of strategic initiatives - Lisa Gavales, a member of Destination Maternity's Board of Directors, said, "As the company strives to improve its performance and deliver profitable growth, the Board of Directors unanimously determined that the company would benefit from new leadership and enhanced execution. In addition to beginning an active and immediate search for a new permanent CEO, the Board will also conduct a comprehensive review of the company's strategic initiatives to ensure that the company is pursuing an aggressive strategy to effect real and sizeable change in the business."

16:50 EDT Tailored Brands down 10% to $4.98 after Q2 profit guidance trails estimates

16:45 EDT RH up 21% to $115.38 after Q1 results beat estimates, FY19 guidance raised - The company also announced it is moving certain production, product development out of China.

16:39 EDT Royal Gold CEO sells nearly 32,000 common shares - In a regulatory filing, Royal Gold president and CEO Tony A. Jensen disclosed the sale of 31,936 common shares of the company at a price of $93.62 per share.

16:36 EDT Semtech supports deployment of Birdz's new LoRaWAN based water metering network - Semtech announced that Birdz, a subsidiary of Nova Veolia and a global leader in optimized resource management, is continuing its use of LoRa devices and wireless radio frequency technology for future deployments of its smart meters. "Semtech's LoRa Technology is perfectly suited for smart water metering solutions due to its deep indoor and long range performance and low power consumption," said Xavier Mathieu, CEO at Birdz. "LoRa-based metering sensors can be deployed into existing infrastructure either outdoors or indoors and offer strong connectivity in dense city settings. Birdz offers the ability to integrate Internet of Things services and devices in the network, such as water leak detectors, fire hydrant monitors and water quality probes. By utilizing LoRaWAN(R)-based networks, we will provide better coverage and grow existing networks to connect even more devices to meet our customers' needs."

16:31 EDT Q2 Holdings CEO sells 120K shares and CFO sells 15K shares of common stock - In a regulatory filing, Q2 Holdings disclosed that its CEO Matthew Flake sold 120K shares and CFO Jennifer Harris sold 15K shares of common stock on June 10th. The total transaction size for the CEO was $8.34M and for CFO was $1.05M.

16:25 EDT AvalonBay VP Leo Horey sells over $1M in company shares - AvalonBay VP Leo Horey disclosed in a filing that he had sold over 5,000 shares of company stock at an average price of $209.86 per share between June 10 and June 12. The total transaction value of the sale was $1,049,275.

16:22 EDT RH says moving certain production, product development out of China - RH said that, regarding China tariffs, it has renegotiated product costs and selectively raised prices to mitigate the impact of the increase from 10 to 25 percent. The company said it is also moving certain production and new product development out of China, plus exploring new partnerships and expanding its own manufacturing facilities in the United States. "Long term, we do not believe the current trade climate will impair our ability to achieve our stated financial goals and the expected impact from the increased tariffs is embedded in our guidance for the year," the company said.

16:20 EDT AMC Networks CFO sells 27.2K shares of common stock - In a regulatory filing, AMC Networks disclosed that its CFO Sean Sullivan sold 27.2K shares of common stock on June 10th. The total transaction size was $1.49M.

16:17 EDT Culp sees Q1 pre-tax income $2.5M-$3.2M - Commenting on the outlook for the first quarter of fiscal 2020, Bowling said, "At this time, we expect overall sales to be slightly higher as compared with the first quarter of fiscal 2019. The first quarter of fiscal 2020 will have one more week than the first quarter of the prior year, or 14 weeks compared with 13 weeks."

16:10 EDT Oil-Dri Corporation of America says Steven Cole to retire from company board - Oil-Dri Corporation of America announced that effective June 12, John Steven Cole, President, Cole & Associates will retire from the company's Board of Directors. Paul M. Hindsley, Managing Director and Partner, William Blair & Company, has been appointed to replace Mr. Cole on its Board and Audit Committee. John Steven Cole joined the Board in 1981 and served as a member of both the Audit and Executive Committees. Mr. Cole is President of Cole & Associates, an international consulting firm, and is an accomplished advisor, providing leadership in product & technical development and general management to many companies and organizations.

16:07 EDT Cherokee appoints Evan Hengel to additional role of chairman - Cherokee Global Brands announced that the company has appointed current Director Evan Hengel to Chairman of the Board of Directors, effective immediately. Hengel has served as a member of the Company's board since October 2018 and brings over 12 years of experience navigating complex financial, operational, and transactional processes. Since 2017, he has served as a managing director at the Berkeley Research Group. Mr. Hengel has considerable experience guiding management, boards of directors, and other stakeholders as both an advisor and interim executive. His clients include companies operating in the apparel and consumer products industries, as well as healthcare, manufacturing, technology and entertainment. Mr. Hengel received a B.S. with honors from the University of Kansas.

16:07 EDT Oxford Industries reports Q1 SSS up 2% - CEO Thomas Chubb says: "Looking ahead, we continue to expect solid increases in operating income and EPS in fiscal 2019. The proposed China tariffs have created some near-term uncertainty in the marketplace and our efforts are well-underway to mitigate the potential impact. We believe our powerful brand portfolio and disciplined approach to distribution, combined with the experiential nature of our brands, helps set Oxford apart and provides the Company with important competitive advantages, especially in the current retail environment. Our highly talented teams are energized and committed to executing the strategies we've put in place to delight our customers today, tomorrow and well into the future."

16:05 EDT Manning & Napier reports preliminary AUM $20.6B as of May 31 - Compared with $21.2B at April 30, and $21.1B at March 31.

16:03 EDT AbbVie granted orphan status for myelodysplastic syndrome treatment - The FDA granted AbbVie orphan status for Venclexta, its treatment of myelodysplastic syndromes. Reference Link

16:01 EDT PTC forms strategic alliance with Vodafone Business - PTC (PTC) and Vodafone Business (VOD) announced from the LiveWorx digital transformation event a strategic alliance that builds on an existing three-year relationship and will enable customers across multiple industry segments to rapidly develop and deploy revenue-generating IoT and AR applications. Commencing in June 2019, this alliance will combine the strengths of both companies to enable customers to more simply create an end-to-end solution to solve business challenges. These challenges could include improving the customer experience, reducing the cost of operations, or building better products and services. By enabling smart decision-making capabilities, supporting rapid development, and tapping into existing expertise, the companies aim to significantly reduce extended development processes, enabling companies to scale at a much quicker pace. PTC and Vodafone Business will showcase the capabilities of the alliance at PTC's annual digital transformation event, LiveWorx, between June 10-13 in Boston.

16:00 EDT Savara trading halted, news pending

15:41 EDT Next Games to make mobile game based on Netflix's 'Stranger Things' - Finnish game developer Next Games announced a free-to-play mobile game title based on the hit Netflix original series "Stranger Things." The location-based puzzle RPG game is currently slated for release in 2020 on iOS and Android platforms. The mobile game will reimagine the Stranger Things universe in the style of an 80's Saturday morning cartoon. Through location-based mechanics and Google Maps integration, players can explore The Upside Down hidden around them in their daily travels and work with fellow fans to fight back its emerging evils, Next said. Teemu Huuhtanen, CEO, Next Games, commented, "We are huge fans of Stranger Things and thrilled to work together with Netflix to bring our shared vision of Stranger Things into life in a mobile game format. Our core focus will be to deliver on Stranger Things' rich and intense themes like friendship and supernatural adventure, and translate these into snack-sized entertainment on your mobile device. Combined with Netflix's second-to none ability to reach audiences across the globe, we will deploy all of our accumulated creative and technological expertise to create a game for the fans of the series all around the world."

15:04 EDT SunTrust and BB&T announced Truist as the name for the combined company - BB&T Corporation (BBT) and SunTrust Banks (STI) announced Truist as the name for the combined company to be created through their merger of equals. Truist will be the sixth-largest U.S. bank holding company serving more than 10 million households in the U.S., with a leading presence in many of the most attractive, high-growth markets in the country. Building on 275 years of combined history and culture, Truist's additional size and scale will redefine the client experience through innovative technology and create meaningful change in its communities. "With the merger of equals, our goal is to create a bold, transformative organization that delivers a smarter and easier client experience through technology and human connection," said BB&T Chairman and Chief Executive Officer Kelly S. King, who will serve as the Chairman and CEO of the combined company. "True to the heritage of both companies, Truist will reflect what we stand for - a shared belief in building a better future for our clients and communities."

14:40 EDT Landmark Dividend acquires Flexential data center in Fort Lauderdale - Landmark Dividend announced that it acquired the Flexential data center in Fort Lauderdale, Florida in February 2019. The 64,000 square foot data center is fully occupied by Flexential, a leading data center services provider with 41 data centers across 21 domestic and international markets. The property is designed to withstand hurricane-force winds and is strategically positioned in the growing Fort Lauderdale/South Florida data center market, providing Edge and Cloud access along with managed services and colocation offerings. The site also benefits from low electricity costs, attractive tax incentives, and robust multi-carrier fiber optic networks and resilient electrical infrastructure. This acquisition marks the 11th data center asset that Landmark and its affiliates have closed since the Digital Infrastructure division was formed in the fourth quarter of 2017. "We are extremely proud to be associated with the Flexential team and look forward to growing this successful relationship further in the future," said Christof Hammerli, Executive Vice President, Digital Infrastructure, at Landmark. Tim Brazy, Chief Executive Officer of Landmark, added, "Landmark has made a major commitment to the industry and has built a best-in-class platform in the data center space over the last 18 months, leveraging one of the most successful track records in the industry. We are deeply committed to accelerating our efforts in the industry by actively growing our portfolio of assets throughout North America and internationally."

14:29 EDT Ceridian named as Gate 3 supplier by Government of Canada - Ceridian HCM Holding announced that it has been named as a Gate 3 supplier by the Government of Canada. "Following an innovative and agile procurement process, Ceridian will collaborate with the Government of Canada to co-design and deliver Next Generation HR and pay solutions for the federal public service," the company stated.

14:08 EDT Epic Games acquires video chat app Houseparty - Video chat app Houseparty announced in a blog post that it is being acquired by Epic Games, the video game company behind "Fortnite." "Houseparty is the synchronous social platform that lets you connect face-to-face with the people you care about most," Houseparty said. "By teaming up with Epic, creator of Fortnite and Unreal Engine, we'll be able to help even more people connect with their friends, family, and peers." "Houseparty brings people together, creating positive social interactions in real time," said Tim Sweeney, founder and CEO of Epic Games. "By teaming up, we can build even more fun, shared experiences than what could be achieved alone." Investors in Epic include Tencent (TCEHY), Disney (DIS), and KKR (KKR). Reference Link

13:42 EDT FARE, partners say 'discouraged' by ICER review of peanut allergy therapies - Food Allergy Research & Education, or "FARE," the American College of Allergy, Asthma and Immunology and the Allergy & Asthma Network jointly issued a statement regarding ongoing review of the comparative clinical effectiveness and value of treatments for peanut allergy currently being conducted by the Institute for Clinical and Economic Review, or "ICER." The joint statement said in part: "On Tuesday, June 11, 2019, ICER convened a meeting of the California Technology Assessment Forum to review its assessment of Viaskin Peanut from DBV Technologies (DBVT) and AR101 from Aimmune Therapeutics (AIMT), two therapies designed to induce immune tolerance. These emerging therapies represent the most significant breakthroughs to date for patients managing food allergies and their caregivers...We thank ICER for the extensive work undertaken to collect and review evidence and data, and for engaging with a variety of stakeholders throughout this process. While ICER appropriately took into account the psychosocial burden of peanut allergy in its assessment, recognizing recently published quality-of-life data, we are discouraged that ICER did not more thoroughly consider the complexity and nuances of available research on immunotherapy in evaluating the benefit these therapies can have on patients managing peanut allergy...We agree that more data on the long-term benefit and protection that can be achieved are needed. However, we have serious concerns about the impact of using computed data on reactions during therapy on ICER's evidence rating without appropriate consideration of the distinctions between medical risks occurring with predictable adverse events during therapy and an unforeseen accidental exposure to peanut in an environment where no emergency treatment is readily available...As organizations representing the voice of patients and thousands of practicing allergists, we are disappointed that ICER did not adopt a more patient-driven approach in assessing the value and benefit of AR101 and Viaskin Peanut. We strongly urge ICER in its final report to reach a decision that ultimately increases their accessibility and takes into account the true impact of treatment and the breakthrough nature of these therapies." In early afternoon trading, shares of DBV are down 4.5% to $8.38 while Aimmune is flat at $19.75.

13:20 EDT NuStar Energy announces Binding Open Season for Valley Pipeline System expansion - NuStar Energy announced the start of its Binding Open Season for committed refined product transportation on the expanded capacity of its Valley Pipeline System in South Texas. The Valley Pipeline System is an approximately 196-mile refined products pipeline from the Corpus Christi, TX area, to delivery points in Brownsville, TX, Edinburg, TX and Harlingen, TX. The current Valley Pipeline System is capable of transporting approximately 45,000 barrels per day. The expansion project, which includes the construction of a 75-mile loop of the pipeline segment between Seeligson, TX and Edinburg, TX, and improvements at pump stations along the line, is expected to increase the capacity of the Valley Pipeline System by approximately 45,000 BPD. Based on significant customer commitments to utilize the expanded capacity, NuStar is proceeding with the project and the binding open season is intended for additional customer interest for the offered capacity and potential further capacity expansion. NuStar is proposing to make up to 90% of the expanded capacity available to shippers making long-term, ship-or-pay commitments, with at least 10% available for walk-up shippers. The project is expected to be in service in the 3Q19.

12:49 EDT RealPage to acquire data services provider Hipercept - RealPage announced that it has agreed to acquire substantially all of the assets of CRE Global Enterprises, a holding company for Hipercept. Hipercept provides data services and data analytic solutions to institutional real estate owners with over $500B in assets under management operating in the U.S., Asia, Canada and Europe. Steve Winn, Chairman and CEO of RealPage, said, "With the addition of this acquisition to RealPage's previously developed capabilities, RealPage will offer an integrated platform to serve the end-to-end needs of an institutional real estate and alternative asset owner. No longer will customers need to cobble together applications and services to run their business. RealPage can offer a complete solution, supported by managed services, to run their entire operational process."

12:36 EDT CFO of Zebra Olivier Leonetti sells 3,500 shares of company stock - The CFO of Zebra Olivier Leonetti disclosed in a filing that he had sold 3,500 shares of company stock at an average price of $195 on June 10. The total transaction value of the sale was $682,500.

12:29 EDT Bow Street says nominees elected to Mack-Cali board of directors - Bow Street, a New York-based investment firm that beneficially owns approximately 4.5% of the outstanding shares of common stock of Mack-Cali Realty, announced that based on proxies submitted to the independent Inspector of Election for Mack-Cali's 2019 Annual Meeting of Shareholders, preliminary results indicate that Mack-Cali shareholders have elected Bow Street's nominees Alan Batkin, Frederic Cumenal, MaryAnne Gilmartin and Nori Gerardo Lietz to the Mack-Cali Board of Directors. Akiva Katz and Howard Shainker, Managing Partners of Bow Street, said, "Shareholders have spoken loudly and presented the Company with a clear mandate for change. Now, the real work begins. Alan, Frederic, MaryAnne and Nori are excited to roll up their sleeves and work alongside their fellow directors to ensure that a robust strategic alternatives process leaves no stone unturned in creating meaningful value for all shareholders. We have no doubt that with truly independent directors and renewed oversight in the boardroom, Mack-Cali shareholders will finally reap the long-overdue benefits of their investment. The positive governance changes Mack-Cali announced today are the direct result of the unwavering determination of shareholders to hold the Board accountable. We thank all shareholders for their overwhelming support."

12:17 EDT VOXX to sell its German accessories business to HF Company for approx. $19M - VOXX International Corporation announced that it has reached a definitive agreement to sell VOXX German Accessory Holdings, which comprises the operations of Oehlbach Kabel and Schwaiger to HF Company. Under the terms of the Stock Purchase Agreement, HF Company will acquire VOXX German Accessory Holdings GmbH for an enterprise value of approximately EUR17.3M, less inventory adjustments of approximately EUR0.6M. Based on the current Euro to US dollar conversion, this equates to approximately $19M. The final purchase price is subject to further net cash and working capital adjustments. A condition precedent to the closing is the entry by the parties into an Option Agreement granting HF Company the right to purchase the real property occupied by VOXX German Accessory Holdings GmbH in Langenzenn for EUR2.4M, subject to certain contingencies. The completion of the transaction is subject to financing contingencies and the Company anticipates this transaction to close on or around August 31, 2019.

12:00 EDT Jumia Technologies rises 10.1% - Jumia Technologies is up 10.1%, or $2.29 to $24.87.

12:00 EDT FuelCell trading resumes

11:57 EDT Vuzix supports streaming video services on Vuzix Blade Smart Glasses - Vuzix announces support of numerous streaming video services and other consumer applications on its Vuzix Blade Smart Glasses. "The 'Dads and Grads Summer Spree' promotion on the Vuzix Blade is an ideal opportunity for consumers and enterprise customers to own a Blade as it coincides with the just announced availability of popular streaming video applications including Netflix (NFLX), Amazon (AMZN) Prime Video and HBO Go. These Android based applications are now supported by the Vuzix Blade Smart Glasses and available for download from the Vuzix App Store," added the company.

11:34 EDT FuelCell announces license agreement with ExxonMobil Research and Engineering - In a regulatory filing, FuelCell Energy (FCEL) announced that it entered into a license agreement, effective as of June 11, with ExxonMobil Research and Engineering Company (XOM), pursuant to which the company has agreed, subject to the terms of the license agreement, to grant EMRE and its affiliates a non-exclusive, worldwide, fully paid, perpetual, irrevocable, non-transferrable license and right to use the company's patents, data, know-how, improvements, equipment designs, methods, processes and the like to the extent it is useful to research, develop, and commercially exploit carbonate fuel cells in applications in which the fuel cells concentrate carbon dioxide from industrial and power sources and for any other purpose. "Such right and license is sublicensable to third parties performing work for or with EMRE or its affiliates, but shall not otherwise be sublicensable. Upon the payment by EMRE to the company of $10.0M, which is expected to occur within 15 days, EMRE and its affiliates will be fully vested in the rights and licenses granted in the license agreement," the filing stated.

11:11 EDT FuelCell trading halted, news pending

10:38 EDT Ford issues four safety recalls in North America, Canada - Ford Motor Company is issuing three safety recalls in North America and one for Canada only. Ford is issuing a safety recall on select 2011-17 Ford Explorer vehicles. Vehicles that are exposed to frequent full rear suspension articulation may experience a fractured rear suspension toe link. A fracture of a rear toe link significantly diminishes steering control, increasing the risk of a crash. One customer reported hitting a curb when the toe link broke. Ford is not aware of any reports of injury related to this condition in markets included in this action.This action affects approximately 1.2 million vehicles in the United States and federalized territories, approximately 28,000 in Canada and one in Mexico. Ford is issuing a safety recall on select 2013 Ford F-150 vehicles equipped with 5.0-liter and 6.2-liter gasoline engines that had the powertrain control module software reprogrammed as part of recall 19S07. The powertrain control module software used to service these vehicles in accordance with recall 19S07 was incomplete. Ford is not aware of any reports of accident or injury related to this issue. This action affects approximately 123,000 vehicles in North America, including approximately 107,850 in the United States and federalized territories and approximately 15,200 in Canada. Ford is issuing a safety recall for select 2009-16 Ford Econoline vehicles equipped with a 5R110W transmission, 5.4-liter engine, and a school bus or ambulance prep package. Affected vehicles contain a capacitive discharge weld within a coast clutch component in the transmission. This action affects approximately 4,300 vehicles in North America, including 3,868 in the United States and federalized territories and 445 in Canada. Ford is issuing a safety recall in the Canadian provinces of Alberta, Manitoba and Saskatchewan for select 2010-17 Ford Taurus, 2009-17 Ford Flex, 2009-15 Lincoln MKS and 2010-17 Lincoln MKT vehicles. Some vehicles operated in these Canadian provinces may experience a fractured rear suspension toe link. Ford is aware of one report of a crash with minor injuries related to this condition in the markets included in this service action. This action affects approximately 12,000 vehicles in Canada.

10:22 EDT U.S. Bancorp CEO says in a 'great position' from size standpoint

10:20 EDT U.S. Bancorp CEO says sees pressure on NIM later in the year - Comments made by CEO Andy Cecere at the Morgan Stanley Financials Conference.

10:08 EDT Bioverativ treatment of sickle cell disease granted FDA orphan status - Bioverativ Therapeutics was granted FDA orphan designation for its treatment of sickle cell disease, according to a post to the agency's website. Reference Link

10:01 EDT Ultimate Software promotes Adam Rogers to co-CEO, Julie Dodd to COO - Ultimate Software announced that the company's Board of Directors has promoted Adam Rogers to serve as co-CEO alongside Scott Scherr. Rogers joined Ultimate in 1997 and has served as Chief Technology Officer since February 2007. "Adam has been my trusted partner in leading Ultimate and developing our product and technology strategies for more than twenty years. I'm thrilled to welcome him as co-CEO," said Scott Scherr, founder and co-CEO, Ultimate. "Adam brings extraordinary leadership experience and operational expertise to the next phase of our partnership journey together, and I am extremely happy with his well-deserved promotion." In their roles as co-CEOs, Scherr will lead Ultimate's growth and culture strategies through sales, marketing, and human resources; Rogers will lead the company's technology vision, product development, services, and operations, including finance and legal. Julie Dodd has been promoted to COO, reporting to Rogers, and is now responsible for all aspects of operations as well as services at Ultimate. Dodd joined Ultimate in 2007 and has served as Ultimate's Chief Services Officer since 2013, with responsibility for support and implementation for Ultimate's customers.

10:01 EDT TravelCenters signs franchise agreement for branded travel center in Oregon - TravelCenters of America has signed a franchise agreement with Amin Alibhai to open a TA branded travel center located at I-84, exit 353 in Huntington, Oregon. The 19-acre property in Malheur County near Farewell Bend was previously home to the Huntington Travel Plaza.

10:00 EDT Seadrill falls -8.8% - Seadrill is down -8.8%, or -30c to $3.15.

10:00 EDT Central Puerto rises 9.0% - Central Puerto is up 9.0%, or 78c to $9.45.

10:00 EDT MagnaChip rises 15.5% - MagnaChip is up 15.5%, or $1.37 to $10.20.

09:47 EDT PPDAI Group falls -5.4% - PPDAI Group is down -5.4%, or -27c to $4.73.

09:47 EDT Seadrill falls -10.3% - Seadrill is down -10.3%, or -35c to $3.10.

09:47 EDT Netshoes rises 14.5% - Netshoes is up 14.5%, or 44c to $3.48.

09:32 EDT Groupon announces card-linked offers distribution partnership with GasBuddy - Groupon announced a U.S. distribution partnership with GasBuddy. Under the terms of the deal, Groupon will provide GasBuddy with local food and drink merchants' card-linked offers content. "Consumers will be able to load offers directly to an eligible payment card after an easy opt-in enrollment in the GasBuddy app. Once customers visit businesses with these offers and pay with their enrolled card, they'll receive GasBuddy GasBack redeemable for free gas at 95 percent of gas stations across the United States through the Pay with GasBuddy program."

09:16 EDT Bridgeline Digital says seven e-commerce brands have selected Celebros Search - Bridgeline Digital announced that since it acquired the Celebros Search product, seven new e-commerce brands have selected Celebros Search by Bridgeline to power their customer search and merchandising experiences. The combined license agreements for these new customers total over $75,000 in ARR for the Natural Language Processing Search, Machine Learning Algorithms, Dynamic AutoComplete & Merchandising Capabilities, Search Analytics, in addition to hosting and maintenance fees with annual license auto-renewals.

09:14 EDT J. Alexander's shareholder Ancora's nominees recommended by Glass Lewis - J. Alexander's shareholder Ancora Advisors, which beneficially owns approximately 8.76% of the outstanding shares of J. Alexander's, announced that proxy advisory firm Glass Lewis recommends that shareholders vote Ancora's gold proxy card at the company's upcoming annual meeting on June 20 and to withhold their votes from management's incumbent nominees, Timothy Janszen and Ronald Maggard, two current members of the J. Alexander's Board. ISS also recommended that shareholders vote Ancora's proxy card. Glass Lewis stated, among other things: "We observe that the Company's performance - as measured by revenue growth, profitability ratios and EBITDA margins - has largely ranked in the bottom quartile of the peer group in recent years. These findings suggest to us that the company's performance has largely failed to keep pace with its industry peers. (...) "Director Maggard serves as chair of the nominating and corporate governance committee. There are currently no women serving on the company's board.... "the board appears to be resistant to the idea of conducting a broader market canvas, which raises concerns regarding the directors' responsiveness. The board spent only three days considering the Ancora Offer and ... the offer price at least implies a fairly attractive market premium to the company's unaffected share prices over recent time periods. (...) While the company maintains that its future profitability will improve as a result of its planned restaurant redesigns and new restaurant openings, the success of this strategy remains subject to a great deal of uncertainty and execution risk (...) We see no evidence to suggest that the foregoing changes portend a major shift in the Company's direction or strategy in the near term."

09:12 EDT ToughBuilt announces launch of Amazon Mexico storefront - ToughBuilt Industries announced the launch of its Amazon Mexico storefront, as part of the company's global e-commerce initiative. CEO Michael Panosian commented, "As previously announced, we are generating significant traction since the rollout of our Amazon storefront in the U.S. To build on this momentum, we recently launched in Canada and Australia, we are now launching in Mexico, with plans to launch our products on Amazon in other international markets, as well as a variety of additional e-commerce platforms around the world. We are also pleased to announce we have retained Amato and Partners as our Investor Relations advisor."

09:07 EDT iBASEt collaborates with Amazon Web Services to launch manufacturing platform - iBASEt announced a collaboration with AWS, as part of Amazon Web Services' Smart Factory program, to launch iBASEt's cloud-based Digital Manufacturing suite for Aerospace and Defense manufacturers on AWS.

09:06 EDT Wells Fargo's Blinde says focused on high-yield, CD promotions

09:03 EDT Wells Fargo's Blinde says seeing intense competition in deposit-gathering

09:02 EDT Fly Intel: Pre-market Movers - HIGHER: Mattel (MAT), up 6% after LA Times reported the company rejected another unsolicited offer by MGA Entertainment... Tesla (TSLA), up 3% after its annual shareholder meeting... CymaBay (CBAY), up 8% after Raymond James analyst Steven Seedhouse upgraded the stock to Strong Buy from Outperform citing the upside potential he sees following yesterday's pullback in the stock... MagnaChip (MX), up 22% after after raising Q2 revenue guidance... Synlogic (SYBX), up 22% after announcing a platform collaboration to accelerate expansion and development of its pipeline of synthetic biotic medicines using Ginkgo's Bioworks cell programming platform. DOWN AFTER EARNINGS: Dave & Buster's (PLAY), down 17%. ALSO LOWER: Trade Desk (TTD), down 5% after Nomura Instinet analyst Mark Kelley downgraded shares to Reduce from Neutral with an unchanged price target of $144. The company's underlying business fundamentals, "while relatively solid, are out of sync with near- to medium-term investor expectations and the story being told," Kelley tells investors... Medidata (MDSO), down 4% after announcing the signing of a definitive agreement for Dassault (DASTY) to acquire the company in an all-cash transaction at a price of $ 92.25 per share, representing an enterprise value of $5.8B... Lam Research (LRCX), down 3% after Evercore ISI analyst C.J. Muse downgraded the stock to In Line from Outperform and lowered his price target for the shares to $195 from $225. An estimate reset in the second half of 2019, combined with a pushout of a memory recovery to the second half of 2020 from the first half, creates headwinds that will make it difficult for the shares to move higher over the near-term, Muse said.

08:59 EDT On Track Innovations CEO Shlomi Cohen to step down by end of 2019 - On Track Innovations announced that its CEO and member of the Board of Directors, Shlomi Cohen, will step down from the position of CEO by the end of 2019 and will then assume the role of Chairperson of the Board. The company has initiated the process of recruiting a new CEO. After four years as OTI's CEO during one of the most challenging times of the company's history, Cohen will be nominated as the OTI's Chairperson of the Board. In connection with this role, Cohen will undertake to actively support OTI management and provide other services as the OTI Board may request from him. Subject to approval by the company's shareholders, the transition will be effective January 1, 2020.

08:51 EDT Tim Hortons now offering Beyond Meat breakfast sandwiches at Canada stores - Restaurant Brands' (QSR) Tim Hortons unit announced that Beyond Meat (BYND) Breakfast Sandwiches are now available at almost 4,000 Tim Hortons restaurants nationwide in Canada. The Beyond Breakfast Sausage patty in Tim Hortons three new Beyond Meat Breakfast Sandwiches has been created to taste similar to the regular Tim Hortons sausage patty, the company stated. "Canadians are hungry to try our breakfast sandwiches made with Beyond Meat's 100% plant-based sausage patty. We've listened to our guests and are excited to be able to offer three delicious breakfast sandwiches that vegans, vegetarians, flexitarians and meat lovers can feel good about," said Mike Hancock, Chief Operations Officer, Tim Hortons. In pre-market trading, Beyond Meat shares are up $1.51, or 1%, to $127.55.

08:50 EDT Wells Fargo sees 2019 NII at the lower end of down 2%-5% range - Comments made by Treasurer Neal Blinde at the Morgan Stanley Financials Conference.

08:41 EDT Ford says evaluating options after Federal Circuit ruled in CBP's favor - In a regulatory filing, Ford said that on March 8, 2013, U.S. Customs and Border Protection ruled that Transit Connects imported as passenger wagons and later converted into cargo vans are subject to the 25% duty applicable to cargo vehicles, rather than the 2.5% duty applicable to passenger vehicles. As a result of the ruling, CBP is requiring Ford to pay the 25% duty upon importation of Transit Connects that will be converted to cargo vehicles, and is seeking the difference in duty rates for prior imports. The company's protest of the ruling within CBP was denied, and Ford filed a challenge in the U.S. Court of International Trade, or "CIT." On August 9, 2017, the CIT ruled in Ford's favor. On October 6, 2017, CBP filed a notice of appeal to the U.S. Court of Appeals for the Federal Circuit, and on June 7, 2019, a panel of three Federal Circuit judges ruled in favor of CBP. "We are evaluating our options following the most recent ruling. If we ultimately receive a favorable ruling, we will receive a refund of the contested amounts paid and we will treat the refund as a special item. Similarly, if we are required to pay the higher rate for prior imports, the payment will be treated as a special item. Accordingly, the company adjusted EBIT guidance provided above is not affected by either a refund or a payment related to this matter," Ford said in the filing.

08:39 EDT TheStreet CEO says Maven acquisition 'a good outcome' for shareholders - Eric Lundberg, CEO and CFO of TheStreet said, "This is a good outcome for TheStreet's shareholders. For over a year we have had a strategic committee comprised entirely of independent directors tasked with evaluating strategic alternatives for the business with the assistance of a financial advisor. The first step was the successful sale of our RateWatch business in June 2018, followed by the sale of TheDeal and BoardEx which closed earlier this year, followed by a substantial distribution to our stockholders from the proceeds of those sales at the end of April. After taking into account the ongoing development needs and operating costs of the remaining consumer business as a stand-alone public company, we believe this agreement represents the best way to maximize value to TheStreet shareholders."

08:39 EDT Ford announces field service action to fix Explorer suspension issue - In a regulatory filing, Ford Motor reported that it is announcing a field service action to correct a suspension issue in certain model year 2011 through 2017 Explorer vehicles. The cost of the action, which will be incurred by its North America business unit, is estimated to be $180M. The expense will be reflected in second quarter 2019 results. "For the full year, we continue to expect company adjusted EBIT to be higher than in 2018," Ford said in the filing.

08:37 EDT Koppers Holdings ceasing activities at Follansbee, WV, facility - Koppers Holdings plans to cease remaining production activities at its facility located in Follansbee, West Virginia. Subsequent to the commissioning of a new naphthalene refining plant in Stickney, Illinois, the company ceased naphthalene refining activities at the Follansbee facility in the fourth quarter of 2018. This final development, which will ultimately affect 48 employees, is driven by market conditions over the past decade that resulted in lower overall supply of raw material from North American steel manufacturers and the long-term changing footprint of the aluminum sector in the United States. The company expects to ramp down production over the next few months with plant decommissioning and tank cleaning activities to be completed by 4Q20. The closure of Follansbee represents the final step in reducing the CMC global footprint of facilities from 11 to four. The company anticipates that this action will result in pre-tax charges to earnings of $4M-$6M in Q2 related to asset write-downs and site clean-up while future cash requirements to close the facility are approximately $20M. The closure will be funded through cash savings from winding down operations at the site which is estimated at $4M in 2019, $9M in 2020, and $16M in 2021 and thereafter.

08:35 EDT T. Rowe Price reports preliminary AUM $1.07T at May 31 - T. Rowe Price reported preliminary month-end assets under management of $1.07T as of May 31. Client transfers from mutual funds to other portfolios, including trusts and separate accounts, were $0.3B in May and $2.7B for the quarter-to-date period ended May 31. This brings total client transfers for the year-to-date period ended May 31 to $8.8B.

08:34 EDT Inpixon collaborates with the National Anti-Organized Retail Crime Association - Inpixon announced it is collaborating with the National Anti-Organized Retail Crime Association to combat retail crime by providing a free 90-day trial offer for IPA Video to retail members of national or regional organized retail crime associations. IPA Video uses a unique, patent-pending process that correlates radio frequency device presence to each security video frame in order to help retailers identify persons-of-interest, to follow them across cameras and off-camera, and to be alerted when the POIs return to the facility.

08:34 EDT Cemtrex changes reverse stock split to 8-to-1 from 6-to-1, effective June 13 - Cemtrex announced that previously announced 6:1 reverse split of its outstanding common shares has been changed by the company's board to 8:1, effective at 9:00 a.m., EDT, on June 13. The board changed the reverse stock split ratio to ensure that the company shall meet with NASDAQ's compliance requirement for maintaining its common stock on the exchange.

08:33 EDT Centene's pending acquisition of WellCare recommended by ISS - Centene (CNC) and WellCare (WCG) reported that independent proxy advisory firm Institutional Shareholder Services - ISS - recommends that Centene and WellCare stockholders vote 'for' all transaction-related proposals at the respective special meetings of stockholders regarding Centene's pending acquisition of WellCare. The Centene Special Meeting of stockholders to vote on the shares of Centene common stock to be issued in connection with the transaction is scheduled to take place on June 24. All stockholders of record of Centene common stock as of the close of business on May 8 will be entitled to vote their shares. The WellCare Special Meeting of stockholders to vote on the transaction is scheduled to take place on June 24.

08:33 EDT Nordic American Tankers expects a 'significantly improved' tanker market ahead - The company issued a letter to shareholders which read, "The last 12 months have been the busiest period for Nordic American Tankers ever. Sale of 10 suezmax vessels and delivery of 3 new suezmax units took place in the last six months of 2018 and ensured a renewal of our fleet which count suezmaxes only. The operating costs for the NAT fleet came down further. Maximizing dividend is our strategy. We also aim at reducing the debt level and thereby lowering the cash break even further. The new 5-year loan of $306 million that we announced in February this year, is a key element in this strategy of maximizing dividend and reducing debt. In 2Q2019, we have seen the normal seasonal downturn in that quarter. We expect a significantly improved tanker market ahead. Recent contracts for 3Q2019 loading confirm this, showing a clear strengthening trend for our vessels. We must remember that political unrest is often good for the tanker market. We now see increased oil exports from the US, which is a new trend. The operational transition of our offshore business to a new group during the first half of 2019 will allow NAT to fully concentrate on the tanker business. With the important changes taking place in NAT during the last year, we are positive on the outlook. The prospects for NAT are good."

08:30 EDT TheStreet to be acquired by TheMaven for $16.5M in cash

08:28 EDT BioCardia announces issuance of patent for image-guided biotherapeutic delivery - BioCardia announced that the China National Intellectual Property Administration has recently issued the Company Patent No: ZL 2014 8 00125575 for "Target Site Selection, Entry and Update with Automatic Image Annotation," with a term to January 7, 2034.The patent describes the use of software that merges images from magnetic resonance imaging or computed tomography with fluoroscopic imaging to plan, document and deliver cell, gene, protein and other therapies using interventional catheter systems. The image-guided technology is designed to enable real time tracking and measurement of therapy delivery, where practitioners can create delivery targets, change orientation, identify regions to avoid, and change course intra-procedure to optimize outcomes. The Company has patents pending for image-guided technology in the U.S., Europe and Japan.

08:25 EDT TheStreet trading halted, news pending

08:23 EDT BofA's Andy Sieg says core adviser headcount growing about 1% per year

08:21 EDT BofA's Andy Sieg says compensation changes for FAs helped fuel growth - Says net new households per year per FA is over 4. Comments made by Andy Sieg, President, Merrill Lynch Wealth Management, at the Morgan Stanley Financials Conference.

08:19 EDT Selecta Biosciences presents data from Phase 2 trial of Sel-212 - Selecta Biosciences will present full data from the company's Phase 2 study of SEL-212 for the treatment of chronic refractory gout at the 2019 European League Against Rheumatism Annual European Congress of Rheumatology in Madrid, Spain. SEL-212 is a combination product candidate designed to sustain control of serum uric acid levels in patients with chronic refractory gout, potentially reducing harmful tissue urate deposits which when left untreated can lead to debilitating gout flares and joint deformity. SEL-212 consists of pegadricase, our proprietary pegylated uricase, co-administered with ImmTOR, designed to mitigate the formation of anti-drug antibodies. ADAs develop due to unwanted immune responses to biologic medicines, rendering these therapies less potent, which remains an issue across multiple therapeutic modalities and disease states including chronic refractory gout. The data to be presented will show that 66% of evaluable patients, maintained serum uric acid levels of less than6mg/dL after five once-monthly treatments of SEL-212 at doses of 0.1 or 0.15 mg/kg of ImmTOR in combination with 0.2 mg/kg of pegadricase. The sustained reduction of SUA correlated with inhibition of ADA formation. Furthermore, reduced tissue urate burden, low gout flare rates and severity of flares were observed in the Phase 2 clinical trial. Only 35% of patients treated with five doses of 0.1-0.15 mg/kg of ImmTOR experienced gout flares after initiation during the first month of treatment with continued reduction of gout flare rates over months two through five. No additional patients reported flares after the second month. SEL-212 has been generally well tolerated at clinically active doses following repeated administrations in the trial.

08:15 EDT Pfizer announces results from ORAL Shift study - Pfizer announced results from ORAL Shift, a Phase 3b/4 study in adult patients with moderately to severely active rheumatoid arthritis, or RA. Patients who achieved low disease activity, or LDA with Xeljanz extended release, or XR, 11 mg once daily, or QD, plus methotrexate, or MTX, after a 24-week open-label run-in period, were randomized to evaluate the efficacy and safety of Xeljanz XR 11 mg QD as monotherapy after MTX withdrawal compared with Xeljanz XR with continued MTX. The study demonstrated non-inferiority of MTX withdrawal with Xeljanz XR 11 mg QD compared to Xeljanz XR 11 mg QD plus MTX at week 48 as measured by the primary endpoint, the change in the Disease Activity Score from randomization at week 24 to the end of the double-blind MTX withdrawal phase at week 48. The study results will be presented during a late-breaking oral session at the European Congress of Rheumatology, or EULAR. For the primary efficacy analysis, patients who achieved Clinical Disease Activity Index low disease activity at week 24 were randomized into the MTX withdrawal phase resulting in least squares mean changes in DAS28-4 from weeks 24 to 48 of 0.33 and 0.03 in the Xeljanz XR monotherapy and Xeljanz XR plus MTX groups, respectively. The primary analysis showed that Xeljanz XR 11 mg QD monotherapy was non-inferior to Xeljanz XR 11 mg QD with MTX at week 48. The safety findings in ORAL Shift include the most frequently reported adverse events, or AEs, for each study group in the double-blind treatment period of nasopharyngitis, upper respiratory tract infection and bronchitis. Rates of AEs, serious AEs, or SAEs, and discontinuations due to AEs were generally comparable between treatment arms. In the Xeljanz XR monotherapy group, there were 10 SAEs and 5 discontinuations due to AEs. In the Xeljanz XR plus MTX group, there were 5 SAEs and 5 discontinuations due to AEs. During the double-blind withdrawal phase of the study, AEs were reported in 40.5% of patients in the Xeljanz XR monotherapy treatment group and 41.0% of patients in the Xeljanz XR plus MTX treatment group. In addition, SAEs were reported in 3.8% of patients in the Xeljanz XR monotherapy treatment group and 1.9% of patients in the Xeljanz XR plus MTX treatment group. In the double-blind treatment period, there were two deaths reported in the Xeljanz XR plus MTX treatment group.

08:10 EDT Corbus Pharmaceuticals to present lenabasum open-label extension data at EULAR - Corbus Pharmaceuticals Holdings announced continued favorable safety and durable improvement in efficacy outcomes at 21 months compared to 12 months in open-label extensions of lenabasum Phase 2 studies in two rare and serious autoimmune diseases: systemic sclerosis and dermatomyositis. Durable improvement was observed in the ACR CRISS score, which remained greater than or equal to 0.95 from month 12 through month 21 in the OLE, and in change in mRSS, which improved greater than 9.8 points during the same time. An ACR CRISS score of greater than or equal to 0.60 has been reported to be medically important, as has an improvement of -4 to -5 points in mRSS. 81% of subjects were still enrolled in the OLE at month 21. Patient and physician global assessments of health, skin symptoms, itch, and patient-reported disability and function showed either stabilization or increasing improvement during the OLE from month 12 through 21. Mean FVC % predicted declined -3.2% from study start through latest data cut in March 2019. No severe AEs or study discontinuations related to lenabasum to date in these studies. 35 of 36 subjects had greater than or equal to 1 AE during greater than or equal to 21 months dosing the OLE, for a total of 249 AEs in the OLE through March 5, 2019. Seven serious AEs, all unrelated to lenabasum, occurred in 5 of 36 subjects: 1 each of scleroderma renal crisis, thrombocytopenic microangiopathy, iron deficiency anemia, multiple fractures, herpes zoster; and 2 AEs each of ischemic digital ulcers. AEs leading to study discontinuation, both unrelated to lenabasum, occurred in 2 of 36 subjects; tendonitis and scleroderma renal crisis. AEs possibly related to lenabasum occurred in 4 of 36 subjects. Three of 36 subjects had AEs judged to be probably or definitely related to lenabasum: 1 had mild fatigue, 1 had a moderate skin ulcer and moderate lymph node pain, and 1 had mild disturbance in attention, mild lethargy, and moderate feeling abnormal. Efficacy and safety of lenabasum in SSc is currently being evaluated in the Company's international, multicenter RESOLVE-1 Phase 3 study, with data expected in the summer of 2020. Lenabasum has been granted Orphan Drug Designation and Fast Track designation for the treatment of SSc from the FDA and Orphan Designation for the treatment of SSc from the EMA. Lenabasum is not approved for the treatment of systemic sclerosis. The Cutaneous Dermatomyositis Activity and Severity Index activity score continued to improve in the OLE with a mean improvement of -21.8 points at month 16. An improvement of -4 to -5 points in CDASI activity score is considered medically important. 90% of subjects were still enrolled in the OLE at month 16. An increasing number of subjects reached low disease activity at month 16, with CDASI activity score less than or equal to 14. Continued improvement or stable improvement from month 12 to month 16 was observed during the OLE in patient- and physician-reported global disease activity, physician assessment of extra-muscular disease activity, patient-reported global assessment of skin activity, skin symptoms, itch, hair loss, and pain. No serious AEs and no AEs leading to study discontinuation occurred. 100% of 20 subjects had greater than or equal to 1 AE during greater than or equal to 16 months dosing the OLE, for a total of 76 AEs in the OLE through March 5, 2019. AEs possibly related to lenabasum occurred in 7 subjects. One had a mild AE of fatigue judged to be probably related to lenabasum. Lenabasum treatment was associated with a reduction in skin biopsies of CD4+ T cells, CB2 expression by T cells, interferon-beta and IFN-gamma mRNA and protein expression, IL-31 and CB2 protein expression in DM. Efficacy and safety of lenabasum in DM is currently being evaluated in the Company's international, multicenter DETERMINE Phase 3 study. Lenabasum has been granted Orphan Drug Designation for the treatment of DM from the FDA and EMA. Lenabasum is not approved for the treatment of dermatomyositis.

08:08 EDT Aurinia Pharmaceuticals holder ILJIN urges holders to vote for their nominees - ILJIN, a founding shareholder of Aurinia Pharmaceuticals, which together with certain affiliates holds an approximate 14% ownership interest in Aurinia, filed an investor presentation on SEDAR in connection with the corporation's upcoming Annual General Meeting of Shareholders to be held on Wednesday, June 26. Young-Hwa Kim, CEO of ILJIN, said, "ILJIN has worked quietly behind the scenes for over two years to help Aurinia improve its corporate governance and ultimately realize its tremendous potential. While the incumbent Board has rejected our good faith attempts to engage, Aurinia shareholders now have a choice. The future is in your hands. We urge you to vote your GREEN Proxy or GREEN VIF in favor of a more qualified and independent board, better governance and leadership stability, and a bright future for Aurinia." Shareholders are urged to read the circular and vote ONLY the GREEN proxy or GREEN VIF.

08:06 EDT Insys Therapeutics receives court approval for 'First Day' motions - INSYS Therapeutics announced that on June 11, 2019 INSYS received interim approvals from the U.S. Bankruptcy Court for the District of Delaware for its First Day motions related to the Chapter 11 petitions filed on June 10, 2019. CEO Andrew Long said, "This is an important step forward in our court-supervised process, which is intended to fairly and transparently address the Company's legacy legal liabilities. I would like to thank our team for their continued hard work and dedication as we move forward with our asset sale process." The Court granted INSYS interim approval to continue its existing cash management system to collect and disburse cash generated by the business. In addition, INSYS received Court approval to, among other things, continue payment of employee wages and benefits and to continue programs offered to customers. The Company also received approval to continue to pay vendors and other providers essential to the Company's operations in full for goods and services provided after the Chapter 11 filing.

08:05 EDT Blue Apron appoints Irina Krechmer as Chief Technology Officer - Blue Apron announced the appointment of Irina Krechmer as Chief Technology Officer, with an expected start date of June 17. She will be responsible for all aspects of the company's technology strategy, focusing on enhancing its platform to drive growth, and will report to President and CEO Linda Findley Kozlowski. Krechmer most recently served as VP of Engineering at XO Group.

08:03 EDT Altimmune appoints Will Brown as CFO - Altimmune announced it has appointed Will Brown as CFO. Brown has been serving as the acting CFO since May 2018. Brown was appointed acting CFO and principal accounting officer in May 2018 after having consulted with the company since February 2018.

08:02 EDT Legg Mason reports preliminary AUM $757.9B as of May 31 - This month's AUM included long-term net outflows of approximately $0.6B, driven by equity outflows of $1.6B, partially offset by fixed income and alternative inflows of $0.7B and $0.3B, respectively. AUM also included liquidity outflows of $0.6B and a negative foreign exchange impact of $0.2B.

07:38 EDT Dassault acquires Medidata for $92.25 per share in cash or $5.8B - Dassault Systemes (DASTY) and Medidata Solutions (MDSO) announced overnight the signing of a definitive agreement for Dassault to acquire Medidata in an all-cash transaction at a price of $ 92.25 per share of Medidata, representing an enterprise value of $5.8B. Shares of Medidata closed yesterday up $3.96 to $94.75. The transaction was unanimously approved by the boards of both companies. "With the acquisition of U.S.-based Medidata and its clinical and commercial solutions, Dassault Systemes will reinforce its position as a science-based company by providing the Life Sciences industry with an integrated business experience platform for an end-to-end approach to research and discovery, development, clinical testing, manufacturing and commercialization of new therapies and health technologies," the company said in a statement. Completion of the acquisition is expected during the last quarter of 2019 and is subject to certain regulatory approvals and approval by the majority of Medidata's shareholders.

07:35 EDT Pacira says new data shows patients using EXPAREL had reduction in opioid use - Pacira BioSciences announced new data on the use of EXPAREL following total hip arthroplasty. The findings show that patients receiving EXPAREL had a significant reduction in opioid use, hospital length of stay, and total hospitalization costs compared to THA patients who did not receive the product. The results were published in The Journal of Medical Economics. This retrospective analysis utilized data from the Premier Healthcare Database from January 2011 through April 2017 for the ten hospitals in the United States with the highest number of THA procedures using EXPAREL. Patients undergoing THA who received EXPAREL were matched in a one-to-one ratio to a control group of patients whose pain management strategy did not include the product. The study population included a total of 12,589 patients, with 7,232 Medicare patients and 5,357 commercial insurance patients. Results showed that patients undergoing THA who received EXPAREL compared to those who did not demonstrated a significant: Decrease in opioid consumption, expressed in oral morphine equivalent dosing, among Medicare and commercial insurance patients; Decrease in average hospital LOS by 0.7 days in both the Medicare and commercial insurance groups; Decrease in total hospitalization costs in the Medicare population; Increase in likelihood to be discharged home in both the Medicare and commercial insurance groups. Results of this study are consistent with findings from several retrospective studies and randomized controlled trials on the use of EXPAREL for total joint replacement procedures, including additional data from Dr. Asche, published last year in The Journal of Medical Economics that found a decrease in opioid consumption, hospital LOS and hospitalization costs for patients receiving EXPAREL following total knee arthroplasty TKA

07:29 EDT Summit Therapeutics no longer plans to intiate SMT-571 Phase 1 trial in 2H19 - The company said, "SMT-571 is a new class antibiotic that is designed to treat infections caused by Neisseria gonorrhoeae. In February 2019, preclinical data was published in the Journal of Antimicrobial Chemotherapy that showed SMT-571 had consistently high potency across over 200 clinically relevant strains of N. gonorrhoeae, including numerous multi-drug resistant and extensively-drug resistant strains. IND-enabling studies are ongoing and expected to continue through the second half of the year. The Phase 1 clinical trial is no longer expected to initiate in H2 2019. Summit is evaluating the design of a clinical trial programme with the potential to shorten the overall clinical development timeline of SMT-571, subject to regulatory approvals. Further updates on the design and timelines for the start of the clinical programme to be provided when available. SMT-571 development is being supported by an award of up to $4.5M from CARB-X."

07:25 EDT True Leaf Medicine announces distribution agreement in Asia with Eagle Vet - True Leaf Brands announced that on May 23, 2019, it signed a non-binding Memorandum of Understanding with international pet care distributor Eagle Vet, launching True Leaf's expansion into the Asian market. Eagle Vet distributes pet healthcare products to more than 20 countries in South East Asia, Africa, and the Middle East. Under the terms of the agreement, Eagle Vet will initially introduce True Leaf products to the expanding Korean pet care market, which is estimated to grow to $4.8B by 2020. Eagle Vet distributes to 5,000 retail stores and veterinary clinics in Korea, and to Coupang and Interpark, two of Korea's largest e-commerce sites.

07:21 EDT Emerald Health Therapeutics contracts for 1,200 acres of Canadian hemp harvest - Emerald Health Therapeutics reports that is has expanded its agreement to purchase harvested hemp flower and leaf, or hemp chaff, from Emerald Health Hemp from 1,000 to 1,200 acres for 2019. EHH is a wholly owned subsidiary of Emerald Health Sciences Inc. and a related party of Emerald. Based on last year's harvest, Emerald expects production from the 1,200 acres to be at least 270,000 kg of hemp chaff in 2019 with, conservatively, approximately 2% cannabidiol content. Emerald estimates that this hemp may yield 3,500 kg of extracted CBD, which it plans to use to manufacture premium oils, softgels and associated value-added products for Canadian adult-use and medical consumers. In 2018, Emerald purchased 134,000 kg of hemp chaff from EHH, which represented total production from 836 acres. The CBD content of this hemp, which was frozen and stored, ranged from 0.8% to 1.0%. This purchase was enabled by the Canadian government's approval on August 10, 2018 to allow harvest of the whole hemp plant for commercial purposes. As a result, licensed companies are now able to use hemp chaff for CBD extraction. In 2019, Emerald expects to receive hemp harvested earlier in the hemp maturation cycle, when biomass and CBD content are approaching their peak. Emerald intends that the past and future harvested hemp will be processed through extraction, with some also going through gel encapsulation, in the Factors Group manufacturing facility in Kelowna, BC. With the support of Emerald, the Factors Group expects to complete final construction on the retrofitting and segmentation of its proposed processing facility in the coming weeks and plans to submit its final evidence package to Health Canada for review and approval shortly thereafter. This operating facility is estimated to have annual extraction capacity of up to one million kg of biomass and can produce up to 600M CBD softgel capsules per year. Emerald currently produces and sells in Canada its SYNC 25 CBD oil in the adult-use market and other high-CBD products in the medical market.

07:13 EDT Summit Therapeutics sees cash, cash equivalents sufficient through Jan. 2020 - The company said, "As at 30 April 2019, total cash and cash equivalents held were GBP28.3M. The Group believes that its existing cash and cash equivalents, anticipated payments from BARDA under its contract for the development of ridinilazole and anticipated payments from CARB-X under its contract for the development of its gonorrhoea antibiotic candidate, will be sufficient to enable the Group to fund its operating expenses and capital expenditure requirements through 31 January 2020."

07:05 EDT Sorrento Therapeutics to explore potential IPO of Scilex Holding Company - Sorrento Therapeutics, announced that it is exploring the possibility of an initial public offering of its majority-owned subsidiary, Scilex Holding Company. No decisions have been taken at this point on the structure or timing of any initial public offering, and no assurance can be given that an initial public offering will be pursued or completed.

07:03 EDT Concert Pharmaceuticals reports results from two Phase 1 CTP-692 studies - Concert Pharmaceuticals reported results from two studies in its Phase 1 program evaluating CTP-692, a deuterium-modified form of D-serine being developed as an adjunctive treatment for schizophrenia. The safety assessments in the single- and multiple-ascending dose trials in healthy volunteers showed that the drug was well tolerated over the dose ranges tested, which include the doses expected to be evaluated in Phase 2 testing. Key blood and urine markers of kidney function did not indicate any signs of renal impairment. These data are consistent with preclinical findings with CTP-692 indicating an improved renal safety profile compared to non-deuterated D-serine which is known to produce renal toxicity in rats. Despite evidence of benefit in multiple published clinical studies of non-deuterated D-serine in the treatment of schizophrenia, its use has been limited due to renal safety concerns. Furthermore, in contrast to non-deuterated D-serine, which has been reported to display highly variable pharmacokinetic behavior in humans, CTP-692 was found to have low inter-individual pharmacokinetic variability. The company expects data from the single-and multiple-ascending dose Phase 1 trials to be presented at a future scientific meeting. The Phase 1 program was designed to assess CTP-692's safety, tolerability and pharmacokinetic profile in healthy volunteers. The Phase 1 program includes three studies: a crossover comparison of CTP-692 versus D-serine, a single-ascending dose study that also assessed the effect of food on the pharmacokinetics of CTP-692 and a multiple-ascending dose trial assessing CTP-692 dosed orally over seven days. In the single- and multiple-ascending dose trials, CTP-692 was evaluated across doses ranging from 0.5 to 4 grams compared to placebo in a total of 72 volunteers. CTP-692 demonstrated a favorable safety, tolerability and pharmacokinetic profile with no serious adverse events reported. In a separate study in 11 healthy volunteers treated in a crossover design with both CTP-692 and D-serine, CTP-692 was found to have increased plasma exposure compared to D-serine.

07:01 EDT Alkermes initiates monotherapy expansion stage of ARTISTRY-1 clinical trial - Alkermes announced the initiation of the monotherapy expansion stage of its ARTISTRY-1 clinical trial to evaluate the efficacy, safety and tolerability of ALKS 4230 in treating patients with renal cell carcinoma or melanoma. Initiation of this portion of the ongoing study follows the identification of 6 microg/kg/day administered intravenously as the recommended monotherapy dose of ALKS 4230 to evaluate in these select tumor types. The maximum tolerated dose of ALKS 4230 has not yet been reached, and the dose-escalation stage of the ARTISTRY-1 study is continuing. ALKS 4230 is a novel, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 receptor complex.

06:49 EDT Summit Materials COO resigns for personal reasons - In a regulatory filing last night, Summit Materials disclosed that Karl Watson, Jr. resigned from his role as Executive Vice President and Chief Operating Officer of the company for personal reasons, effective June 6. "To facilitate an orderly transition, Mr. Watson will remain an employee of the company through June 28, 2019. The company has begun a search to replace Mr. Watson," the filing stated.

06:45 EDT Waddell & Reed reports preliminary AUM $68.6B as of May 31 - Compared to $72.9B on April 30.

06:40 EDT Sapiens enters partnership with Kovrr - Sapiens announced it is partnering with Kovrr, "a predictive cyber risk modeling firm, as part of Sapiens' strategy to maximise its open-API architecture and make innovative third-party and insuretech solutions available to its customers."

06:34 EDT Pioneer Energy receives continued listing standard notice from NYSE - Pioneer Energy announced that it has been notified by the NYSE that its common stock does not satisfy one of the NYSE's standards for continued listing. The NYSE requires that the average closing price per share of a listed company's stock be no less than $1.00 over a consecutive 30 trading-day period. As of June 11, the date of the NYSE notice, the 30 trading-day average closing price of Pioneer Energy common stock was 89c per share. Under the NYSE's rules, Pioneer has six months following receipt of the notification to regain compliance with the minimum share price requirement. Pioneer can regain compliance at any time during the six-month cure period if Pioneer's common stock has a closing share price of at least $1.00 on the last trading day of any calendar month during the six-month period and also has an average closing share price of at least $1.00 over the 30-trading day period ending on the last trading day of that month. During this period, Pioneer's common stock is permitted to continue to trade on the NYSE, but will have an added designation of ".BC" to indicate the status of the common stock as "below compliance." As required by the NYSE, Pioneer intends to notify the NYSE by June 25 of its intent to cure the price deficiency.

06:33 EDT Synlogic and Ginkgo Bioworks to codevelop Synthetic Biotic medicines - Synlogic and Ginkgo Bioworks announced a platform collaboration to accelerate expansion and development of Synlogic's pipeline of Synthetic Biotic medicines using Ginkgo's cell programming platform. The agreement provides an $80.0M equity investment at a premium in Synlogic by Ginkgo and entry into a long-term strategic platform collaboration. Synlogic will use Ginkgo's cell programming platform for building and testing thousands of microbial strains to accelerate progression of early preclinical leads to drug candidates optimized for further clinical development. Ginkgo has purchased 6,340,771 shares of Synlogic common stock as well as pre-funded warrants to purchase up to 2,548,117 shares of Synlogic common stock, both at a price of $9.00 per share. Gross proceeds to Synlogic are approximately $80M. Synlogic paid $30.0M to Ginkgo for synthetic biology services to be provided over an initial period of five years which can be extended. Synlogic has exclusive rights to any Synthetic Biotic medicines that it develops as part of the collaboration and to intellectual property covering such products.

06:24 EDT PayPal's completed acquisition of iZettle approved in UK - PayPal reported the United Kingdom Competition and Markets Authority's decision to provide final and unconditional approval of the company's previously completed acquisition of iZettle. PayPal will now begin to integrate iZettle's products and teams in the UK and around the globe.

06:17 EDT KKR offers to buy out Axel Springer minority shareholders - Axel Springer (AXELF) has signed today an investor agreement with Traviata II S.a r.l., a holding company owned by funds advised by investment firm KKR (KKR) to create a strategic partnership supporting the long-term growth and investment strategy of the company. In this context, the Investor has announced its intention to launch a voluntary public tender Offer an Offer price of EUR 63.00 per share in cash for all outstanding shares of Axel Springer. The announcement and Offer by KKR is the result of a strategic review and stringent process initiated by the Executive Board of Axel Springer in the context of its growth strategy presented in December 2018. The Executive Board of Axel Springer has evaluated different options including finding a committed shareholder and strategic partner, who supports the realization of the company's strategy, while at the same time offering all shareholders of Axel Springer the opportunity to realize a significant part of the envisaged long-term value creation immediately upfront. The Offer Price represents a premium of c. 39.7 percent to the unaffected share price of EUR 45.10 on 29 May 2019, before Axel Springer confirmed discussions with KKR about a potential strategic investment. The Executive Board and the Supervisory Board of Axel Springer support the Offer and the strategic partnership. Current shareholders Friede Springer, who indirectly and directly controls 42.6 percent of the shares, and CEO Mathias Dopfner, who owns 2.8 percent of the shares, have separately agreed with the Investor to retain their shareholdings in Axel Springer SE. The current Executive Board members of Axel Springer will continue to lead the company.

06:01 EDT Carvana expands in South Carolina - Carvana grew its South Carolina presence, offering as-soon-as-next-day vehicle delivery to Florence and Spartanburg. This launch marks the seventh market for Carvana in the Palmetto State.

05:55 EDT KBR wins seat on $6B State Department contract - KBR announced it has been awarded an indefinite-delivery, indefinite-quantity, or IDIQ. contract by the U.S. Department of State, or DoS, for life support, logistics, operations and maintenance services at U.S. government facilities worldwide. The Diplomatic Platform Support Services, or DiPSS, contract, which has a maximum ceiling of $6 billion, is a new award for KBR. DiPSS will allow the DoS to procure services at overseas locations, and will realize cost savings, and achieve economies of scale. Under this multi-award contract, KBR will have the opportunity to compete on task orders to provide a full range of services to the DoS and other U.S. government agencies across the globe, often in high threat contingency environments. This work is expected to be performed over a five year period ending in 2024.

05:36 EDT PepsiCo appoints Ram Krishnan as Global Chief Commercial Officer - PepsiCo announced that Ram Krishnan, currently CEO, Greater China for PepsiCo, has been appointed to the role of PepsiCo's Global Chief Commercial Officer. Krishnan will continue to lead PepsiCo's Greater China sector at this point. He replaces Laxman Narasimhan who is departing the company to become CEO of the Reckitt Benckiser Group.

05:08 EDT Genentech says Rituxan granted Priority Review by FDA - Genentech, a member of the Roche Group, announced that the FDA has accepted the company's supplemental Biologics License Application, or sBLA, and granted Priority Review for the use of Rituxan, in combination with glucocorticoids, or GCC, for the treatment of granulomatosis with polyangiitis, or GPA, and microscopic polyangiitis, or MPA, in children two years of age and older. GPA and MPA are rare, potentially life-threatening diseases affecting small and medium sized blood vessels.