Stockwinners Market Radar for June 04, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
PAC | Hot Stocks19:59 EDT GAP Airports reports preliminary May traffic up 11.7% - GAP Airports announced preliminary terminal passenger traffic figures for the month of May 2019, compared to traffic figures for May 2018. During May 2019, total terminal passengers increased by 11.7% at the company's 13 airports, compared to the same period of the previous year. Domestic passenger traffic increased by 12.3%, while international passenger traffic increased by 10.6%.
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AMBA... | Hot Stocks18:54 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: Ambarella (AMBA) up 15.7%... HealthEquity (HQY) up 3.8%... Quanex Building (NX) up 2.9%... Salesforce.com (CRM) up 2.8%. ALSO HIGHER: Tivo (TIVO) up 8.9% after favorable determination from ITC on Comcast Rovi infringement... GoPro (GPRO) up 3.4% after D.E. Shaw disclosed passive stake. DOWN AFTER EARNINGS: Pivotal Software (PVTL) down 28.8%... GameStop (GME) down 23.7%... Guidewire Software (GWRE) down 5.2%. ALSO LOWER: Northwest Natural Holding (NWN) down 5.0% after equity offering... Altair Engineering (ALTR) down 4.6% after equity offering... Descartes Systems (DSGX) down 1.4% after equity offering... Skyworks Solutions (SWKS) down 0.9% after cutting Q3 guidance. Movers as of 18:30ET.
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EBS | Hot Stocks18:47 EDT Emergent BioSolutions CEO: We are focused on making Narcan affordable - In an interview on CNBC's Mad Money, Emergent BioSolutions CEO Bob Kramer said: We have a Smallpox vaccine and we expect to contract with the U.S. government shortly... We are focused on making Narcan affordable and accessible to opioid addicts... Our flu product is therapeutic in nature... We do a lot of work in the areas of Anthrax and Smallpox... We like to contract with customers over long durations... Our approach to pricing is different than most pharmaceutical companies.
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CMG | Hot Stocks18:34 EDT Chipotle CFO: Mexican tariff will have minor impact - In an interview on CNBC's Mad Money, Chipotle CFO Jack Hartung said: Mexican tariff impact will be very manageable... We can handle demand, we have lots of capacity available... Digital orders have doubled since last year... We can attract workers, the hard part is keeping them... We are working to invest in employees in first 90 days so we can keep them on board.
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CRM | Hot Stocks18:13 EDT Salesforce CEO says no other software company growing as quickly as we are - Says: Customer 360 is driving opportunities and will continue to be a major growth engine going forward... We are well positioned to double our revenue over next four years... Never positioned better than we are right now... Continue to deepen relationship with U.S. government... Seeing strong momentum beyond U.S... Will no longer break out Mulesoft revenue... Mulesoft contributed $170M in Q1... Sees Salesforce.org purchase adding $150M-$200M in FY20... Economy still very strong... Customer software renewals are very strong. Comments from company's Q1 earnings conference call.
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TIVO | Hot Stocks17:41 EDT TiVo jumps 12% after favorable determination from ITC on Comcast Rovi infringemt - Shares of TiVo are up $1.00 or 12.9% to $8.40 per share in after hours trading following the announcement, while Comcast is relatively flat.
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SLGN | Hot Stocks17:37 EDT Silgan Holdings to close metal container facilities in Mt. Vernon Missouri - Silgan Holdings announced that it is closing its metal container manufacturing facilities in Mt. Vernon, Missouri and Waupun, Wisconsin. The company anticipates closing both of these facilities during the fourth quarter of 2019. These plant closings, in conjunction with the ratification last month of a new labor agreement at the company's Menomonee Falls, Wisconsin metal container manufacturing facility that provides for the company's withdrawal from the Central States Pension Fund for that facility, will result in the company's complete withdrawal from the Central States Pension Fund. Volumes from the closed facilities will be absorbed in existing facilities and in a new plant to be leased in the Midwest of the United States. "Decisions regarding footprint optimization plans are always difficult, and we want to thank our dedicated employees at both facilities for their long service and their anticipated efforts during this transition. At Silgan, these decisions are driven by a relentless pursuit to lower our overall cost structure, improve operating efficiencies and enhance our leading competitive position in our metal container business," said Adam Greenlee, President of Silgan. "Separately, we believe that withdrawing from the Central States Pension Fund and providing our Menomonee Falls employees with a company sponsored benefit plan is a better long-term solution," concluded Mr. Greenlee. The company expects to recognize estimated pre-tax rationalization charges related to the plant closings, excluding charges related to the withdrawal from the Central States Pension Fund, of approximately $5.2M in 2019, approximately $2.1M of which is expected to be realized in the second quarter of 2019 and approximately $2.2M of which will be non-cash. These rationalization charges include the write-down in carrying value of assets, employee severance costs and plant exit costs related to the plant closings. The company's earnings guidance for adjusted net income per diluted share for the full year 2019 and second quarter of 2019 are not impacted by the rationalization charges to be incurred in connection with the plant closings and the withdrawal from the Central States Pension Fund, as these charges are treated as adjustments for purposes of adjusted net income per diluted share. These charges will also not have an impact on the company's estimate of free cash flow for 2019.
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GME | Hot Stocks17:34 EDT GameStop says collectible business will be big part of business going forward - Says expects recent trends in pre-owned business from 2018 to continue. Says anticipates profit in 2019 to be back-end weighted. Says collectible figurines are in high demand as well as shirts. Says no longer saw dividend as effective way to return capital to shareholders. Says PowerUp Rewards has nearly 60M members.
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TECH | Hot Stocks17:31 EDT Bio-Techne to acquire B-MoGen Biotechnologies, terms not stated - Bio-Techne announced that it has reached agreement to acquire all of the stock of B-MoGen Biotechnologies Inc. The transaction has been completed and is being financed through available cash on hand. B-MoGen Biotechnologies of Minneapolis was founded in 2015 as a startup out of the University of Minnesota and has approximately 20 employees.
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CMCSA NFLX | Hot Stocks17:29 EDT Animated series, Jurassic World:Camp Cretaceous, set to debut on Netflix in 2020 - DreamWorks Animation (CMCSA) announced Jurassic World: Camp Cretaceous, an animated action-adventure series, is set to debut globally on Netflix (NFLX) in 2020 as part of an ongoing multi-year agreement with Netflix to produce original animated kids and family programming. Set within the same timeline as the 2015 blockbuster film, Jurassic World, the Netflix original series is inspired by the multi-billion-dollar franchise from Universal Pictures and Amblin Entertainment. Reference Link
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MDT | Hot Stocks17:25 EDT Medtronic awarded $150M Defense Logistics Agency contract - Medtronic has been awarded a maximum $150M firm-fixed-price, indefinite-delivery/indefinite-quantity contract for radiology and imaging systems, subsystems and components along with maintenance services, training and incidental services related to the purchase of equipment. This is a five-year base contract with one five-year option period. This was a competitive acquisition with 51 responses received. Location of performance is Minnesota, with a June 3, 2024, performance completion date. Using customers are Army, Navy, Air Force, Marine Corps and federal civilian agencies. Type of appropriation is FY19 through FY24 defense working capital funds. The contracting activity is the Defense Logistics Agency.
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TIVO CMCSA | Hot Stocks17:22 EDT TiVo receives favorable determination from ITC on Comcast Rovi infringement - TiVo (TIVO) received a favorable determination by Administrative Law Judge MaryJoan McNamara of the International Trade Commission, ITC,that Comcast's (CMCSA) X1 platform infringes Rovi's patents. "We are thrilled by yet another legal victory," said Arvin Patel, Executive Vice President and Chief Intellectual Property Officer at Rovi Corporation, a TiVo company. "This decision demonstrates Comcast's repeated infringement of Rovi's patents. We hope that today's decision will encourage Comcast to pay the necessary licensing fees so their customers can once again access advanced cable features." This is the second favorable ITC determination the Company has received from the ITC. In November 2017, the ITC issued a final ruling that Comcast had infringed two Rovi patents around 'remote record' functionality. Comcast subsequently elected to remove this popular feature from their products. Additionally, on May 23, the ITC instituted a third investigation into Comcast for infringing six Rovi patents including: X1 Sports App, multi-room DVR features, and set-top box integrations of apps like Netflix. That investigation has also been assigned to Administrative Law Judge McNamara.
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LLL | Hot Stocks17:20 EDT L3 Technologies awarded $499.59M Air Force contract for 176 C-130H upgrade - L-3 has been awarded a $499.59M fixed-price-incentive-firm contract for the major avionics upgrade for 176 C-130H aircraft operated by the Air National Guard and the Air Force Reserve Command. This contract provides for engineering and manufacturing development through production and includes training and logistics requirements. Work will be performed predominantly in Waco, Texas and is expected to be complete by September 30, 2029. This award is the result of a competitive acquisition and six offers were received. FY19 research, development, test and evaluation funds in the amount of $37.39M are being obligated at the time of award. Air Force Life Cycle Management Center is the contracting activity.
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GME | Hot Stocks17:20 EDT GameStop says board has eliminated quarterly dividend - Says will have more disciplined approach to capital allocation. Says multi-year transformation is underway. Says needs to declutter stores. Says coming to end of current console cycle. Says this a pivotal time for the company. Says video game hardware sales decreased 35% in Q1. Says hardware comps are comparable to 2013 when new consoles were released. Comments taken from Q1 earnings conference call.
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CC | Hot Stocks17:16 EDT Chemours names Mark Newman COO, Sameer Ralhan CFO - The Chemours Company announced the promotion of Mark Newman to the newly created role of COO. Newman previously served as the company's CFO. As the company's first COO, he will have responsibility for all three global businesses: Titanium Technologies, Fluoroproducts, and Chemical Solutions. Additionally, VP of Business Finance and treasurer Sameer Ralhan has been promoted to the position of senior VP, CFO and treasurer.
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KEYS | Hot Stocks17:14 EDT Keysight Technologies director Cullen sells 16.3K shares of common stock - In a regulatory filing, Keysight Technologies disclosed that its director James Cullen sold 16.3K share of common stock on May 31st. The total transaction size was $1.23M.
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WAL | Hot Stocks17:11 EDT Western Alliance authorizes initiation of 25c regular quarterly dividend - Western Alliance Bancorporation announced its board authorized the initiation of regular quarterly dividends, beginning in the third quarter of 2019. At the board meeting associated with the company's Annual Meeting of Shareholders, the Board approved a 25c per share quarterly dividend to be initially declared at its next meeting on July 30 with the record and payment dates expected to occur in August. "I am pleased to announce the Board's decision to authorize a quarterly dividend for our shareholders," commented Robert Sarver, Executive Chairman. "The dividend demonstrates our continued confidence in the Company's performance outlook, including loan and deposit growth, interest margin, asset quality, operating efficiency and earnings per share. Western Alliance will continue to focus on generating quality loan and deposit growth, reinvesting earnings in our Company to support our sustained development, and pursuing opportunistic mergers and acquisitions."
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SRRA | Hot Stocks17:06 EDT Sierra Oncology to launch MOMENTUM Phase 3 trial in Q4 2019 - Sierra Oncology announced that it has obtained regulatory clarity with the U.S. Food and Drug Administration concerning the design of a Phase 3 clinical trial for momelotinib intended to support potential registration of this differentiated drug candidate for the treatment of previously JAK inhibitor treated myelofibrosis patients. Following receipt of this clarity, Sierra also announced the design of the MOMENTUM Phase 3 clinical trial in myelofibrosis, planned for launch in Q4 2019. "We have held productive discussions with regulators in the US and EU, presenting a holistic analysis of momelotinib's compelling array of positive efficacy and safety data observed in the two previously completed SIMPLIFY Phase 3 clinical studies, along with our strategy to conduct an additional Phase 3 trial intended to support momelotinib's potential registration," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We have been exceedingly pleased with the collaborative nature of these discussions which have culminated in alignment on the path to potential registration for momelotinib. Moreover, we have received constructive input that ensures that the design of the MOMENTUM Phase 3 study has the potential to generate compelling and persuasive clinical data capable of satisfying regulatory requirements."
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PVTL | Hot Stocks17:05 EDT Pivotal Software down 30% to $12.99 after lowering FY20 revenue outlook
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SKT | Hot Stocks17:02 EDT Tanger Factory announces retirement plan of COO Thomas McDonough - Tanger Factory Outlet Centers announced that Thomas E. McDonough, the Company's President and COO, informed the Company of his intent to retire, effective December 31. The Company has retained a leading global search firm to assist in filling the position and further augment its management team as part of its ongoing succession planning.
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LH | Hot Stocks17:00 EDT Medical collections firm used by LabCorp has exposed some patient information - In response to questions it has received, LabCorp announced that it has been notified by American Medical Collection Agency ,AMCA, about unauthorized activity on AMCA's web payment page. According to AMCA, this activity occurred between August 1, 2018, and March 30, 2019. AMCA is an external collection agency used by LabCorp and other healthcare companies. LabCorp has referred approximately 7.7M consumers to AMCA whose data was stored in the affected AMCA system. AMCA's affected system included information provided by LabCorp. That information could include first and last name, date of birth, address, phone, date of service, provider, and balance information. AMCA's affected system also included credit card or bank account information that was provided by the consumer to AMCA . LabCorp provided no ordered test, laboratory results, or diagnostic information to AMCA. AMCA has advised LabCorp that Social Security Numbers and insurance identification information are not stored or maintained for LabCorp consumers. AMCA has informed LabCorp that it is in the process of sending notices to approximately 200,000 LabCorp consumers whose credit card or bank account information may have been accessed. AMCA has not yet provided LabCorp a list of the affected LabCorp consumers or more specific
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AMBA | Hot Stocks16:52 EDT Ambarella up 12% to $44.48 after Q1 results, Q2 revenue view beat estimates
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RDUS | Hot Stocks16:36 EDT Integrated Core Strategies reports 5.9% passive stake in Radius Health - In a regulatory filing, Integrated Core Strategies disclosed a 5.9% stake in Radius Health, which represents about 2.73M shares. The filing does not allow for activism.
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CIR | Hot Stocks16:35 EDT Circor says it will provide update on financial outlook soon - "As we've been communicating directly to you, and our other shareholders, soon we will be providing an update on our financial outlook and ongoing business transformation, including initiatives to drive growth, expand margins, and strengthen the balance sheet. We value the constructive engagement we have had with our shareholders and look forward to discussing further details regarding our plans to deliver shareholder value," said Scott A. Buckhout CEO.
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IT | Hot Stocks16:32 EDT Gartner director Karen Dykstra sold over $272K in company shares - Gartner director Karen Dykstra disclosed in a filing that she had sold 1,812 shares of company stock at an average price of $150.22 per share on June 3, The total transaction value of the sale was $272,199.
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RWLK | Hot Stocks16:31 EDT ReWalk Robotics says FDA clears ReStore system for sale to U.S. rehab centers - ReWalk Robotics, Ltd. announced that the U.S. Food and Drug Administration has cleared the company's ReStore soft exo-suit system for sale to rehabilitation centers across the United States. ReStore is the only soft exo-suit with FDA clearance, and is intended for use in the treatment of stroke survivors with mobility challenges. "The exo-suit achieves our commercial goal to offer a functional and affordable system that can be utilized in the 'Main Street' clinics in every community," said ReWalk CEO Larry Jasinski. "With a launch price of $28,900 as well as leasing options, ReStore offers cutting edge innovation with features that redefine therapy at a price that is accessable for a broader range of clinics than existing robotic technologies. The current gait training reimbursement codes enable immediate penetration and sales growth as part of our pathway to become a break even and profitable company."
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NVEE | Hot Stocks16:21 EDT NV5 Global acquires Page One Consultants, sees accretion - NV5 Global announced that it has acquired Page One Consultants, a Program Management and Construction Quality Assurance firm based in Orlando, Florida. The addition of Page One strategically complements NV5's strong infrastructure, geotechnical design and environmental capabilities in Central Florida, one of the nation's fastest growing markets in construction and infrastructure. The acquisition was completed with a combination of cash and stock and will be immediately accretive to NV5's earnings. "Florida has been a rapid growth market for NV5, where we have completed six acquisitions and experienced solid organic growth," said Dickerson Wright, PE, Chairman and CEO of NV5. "The acquisition of Page One continues to strengthen our capabilities and expand our client base in the aggressive Orlando construction market and also enhances our value proposition for adjacent Central Florida markets, such as Tampa and St. Petersburg."
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SMTC | Hot Stocks16:21 EDT Semtech's LoRa Technology integrated into Axino refrigeration solutions - Semtech announced that Axino Solutions has integrated Semtech's LoRa devices and wireless radio frequency technology into its smart refrigeration solutions to track food temperature for the food retail industry. Axino's LoRa-based solution has been deployed globally including with Migros, Switzerland's largest supermarket chain.
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NWL | Hot Stocks16:21 EDT Newell Brands to sell USPC to Cartamundi Group, terms not disclosed - Newell Brands announced that it has signed a definitive agreement to sell The United States Playing Card Company to Cartamundi Group, a manufacturer and distributor of playing cards and board games. USPC, based in Erlanger, KY is the leader in the production and distribution of premier brands of playing cards, including BICYCLE, BEE, AVIATOR, HOYLE, and FOURNIER. In 2018 net sales for USPC were approximately $112M. Citi acted as financial advisor to Newell Brands on the USPC transaction. It is expected to close in the second half of 2019, subject to customary closing conditions, including regulatory approvals.
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GKOS | Hot Stocks16:19 EDT Study confirms sustained IOP, medication reduction after Glaukos iStent Inject - Glaukos announced that results of an independent, international study published in Advances in Therapy showed standalone implantation of the iStent inject Trabecular Micro-Bypass System in eyes with substantial glaucoma disease burden achieved a 42% reduction in mean intraocular pressure, or IOP, to 14.6 mmHg and an 82% reduction in mean medications to 0.55 at three years postoperative. "The results of this study highlight the profound efficacy and safety profile of iStent inject as a sole procedure in a glaucoma patient population with substantial disease burden," said Dr. Hengerer, the study's author.
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AMBA | Hot Stocks16:17 EDT Ambarella announces new $50M repurchase program - During the second fiscal quarter, Ambarella's Board of Directors authorized a new $50M repurchase program through June 30, 2020. The repurchase program does not obligate the company to acquire any particular amount of ordinary shares, and it may be suspended at any time at the company's discretion.
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PVTL | Hot Stocks16:15 EDT Pivotal Software CEO says 'sales execution and technology landscape' impacted Q1 - CEO Rob Mee says: "We had a solid start to the year with 43% subscription growth and customer expansions continued to fuel our strong net expansion rate of 143%. However, sales execution and a complex technology landscape impacted the quarter. We have taken steps to improve our execution, and remain confident in our strategy and market opportunity for the long term. "
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CRM | Hot Stocks16:15 EDT Salesforce reports remaining performance obligation ended Q1 at $24.9B - Remaining performance obligation ended the first quarter at approximately $24.9B, an increase of 22% year-over-year. This includes approximately $500M related to the remaining performance obligation from MuleSoft. Current remaining performance obligation ended the first quarter at approximately $11.8B, an increase of 23% year-over-year, 24% in constant currency.
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AMEH | Hot Stocks16:13 EDT Apollo Medical acquires Alpha Care Medical Group - Apollo Medical Holdings announced that Allied Physicians of California, a Professional Medical Corporation d.b.a. Allied Pacific of California, or APC, and APC-LSMA Designated Shareholder Medical Corporation, or APC-LSMA, have completed their acquisition of Alpha Care Medical Group. APC is an independent practice association, or IPA, that the Company has determined should be consolidated as a variable interest entity, or VIE with the Company's financial statements under U.S. generally accepted accounting principles. APC-LSMA has as its sole shareholder, Thomas Lam, CEO of the Company and Chief Executive and Financial Officer of APC, and is controlled by APC. On May 31, 2019, under the terms of the stock purchase agreement, APC and APC-LSMA acquired 100% of the capital stock of Alpha Care from Kevin Tyson for an aggregate purchase price of $45M in cash, subject to post-closing adjustments, as defined. The completion of this acquisition will expand the Company's capitated membership population base and deepen its geographic footprint in Southern California.
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EBS | Hot Stocks16:13 EDT Emergent BioSolutions announces FDA approval for Cholera vaccine changes - Emergent BioSolutions announced approval by the FDA of the prior approval supplement, or PAS, submitted by the company for its oral cholera vaccine, Vaxchora. The PAS supports the change in storage conditions of the vaccine from frozen to refrigerated at 2-8 degrees celsius and the transfer of bulk drug substance manufacturing from Emergent's product development facility in San Diego to its manufacturing facility in Bern, Switzerland. The PAS also covers changes in labeling regarding these developments. The company's oral cholera vaccine is the only FDA-licensed vaccine for the prevention of cholera caused by Vibrio cholerae serogroup O1, a potentially serious intestinal disease.
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CRM | Hot Stocks16:11 EDT Salesforce says mark-to-market accounting benefited Q1 adj. EPS by 27c - The company said, "Mark-to-market accounting of the company's strategic investments, required by ASU 2016-01, benefited GAAP diluted earnings per share by 27c based on the US tax rate of 25% and non-GAAP diluted earnings per share by 27c based on our non-GAAP tax rate of 22.5%."
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AMRS | Hot Stocks16:10 EDT Amyris promotes Kathleen Valiasek to Chief Business Officer - Amyris announced the appointment of Kathleen Valiasek, formerly CFO, to Chief Business Officer effective immediately. Valiasek will assume a dedicated role of furthering the company's strategy of collaborating with large, well-funded partners to grow the company's business. Simultaneously, she will continue to oversee the company's financing and investor relations activities. The company also announced that it has appointed Jonathan Wolter as Interim CFO. In this capacity, Wolter will focus primarily upon and assist with completing the Company's audit procedures and process of finalizing and filing its 2018 Annual Report on Form 10-K and Quarterly Report on Form 10-Q for Q1 to bring Amyris into compliance with SEC regulations and Nasdaq listing requirements as quickly as possible. Wolter has extensive experience and expertise in financial management, operations, audit, controls, SEC reporting and compliance. Since 2004 he has served as a partner with FLG Partners where he has been retained as CFO by the boards of multiple public and private companies.
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TGTX | Hot Stocks16:10 EDT TG Therapeutics presents interim data from MZL cohort of UNITY-NHL trial at ASCO - TG Therapeutics presented interim data from the ongoing single-arm marginal zone lymphoma, or MZL, cohort of its Phase 2b UNITY-NHL trial currently evaluating umbralisib as a single agent in patients with relapsed/refractory MZL. Umbralisib is an investigational, oral, once-daily PI3K delta inhibitor with unique inhibition of CK1 epsilon and is currently under development for the treatment of non-Hodgkin lymphoma, or NHL, and chronic lymphocytic leukemia, or CLL. The interim data were presented in an oral session during the American Society of Clinical Oncology, or ASCO, annual meeting. The MZL cohort of UNITY-NHL enrolled patients with relapsed or refractory MZL who had received prior treatment with one or more lines of therapy including at least one anti-CD20 regimen. In August 2018, the trial completed enrollment with 69 treated patients. The interim data reported included safety and tolerability data on all 69 treated patients and efficacy data on 42 patients who were enrolled at least 9 cycles prior to the data cut-off date. The primary endpoint is overall response rate, or ORR, as assessed by IRC using criteria adopted from the International Working Group for malignant lymphoma. ORR by IRC was 52%. Complete response by IRC, or CR was 19%. Partial response by IRC, or PR was 33%. Also there was a 52% ORR, with 17% CR, by IRC assessment for patients who had received 2 or more prior lines of therapy and 88% clinical benefit rate by IRC. All patients achieving a CR by IRC remain on study. Median time to initial response was 2.7 months. Kaplan-Meier, or KM, estimate of progression-free survival, or PFS at 12 months was 66%, with the median PFS not reached Interim safety data were presented for all 69 treated patients with a median duration of exposure of 6.9 months. No unexpected toxicities were observed. The most common adverse events were diarrhea, nausea and fatigue, with the majority of events Grade 1 in severity. The most frequent grade 3 or higher adverse events were neutropenia, diarrhea and ALT/AST increase, observed in 13%, 10% and 10% of patients, respectively. No events of colitis were reported and only 1 event of Grade 3 pneumonitis was reported. Grade 3 infections were limited, occurring in 3 patients. Discontinuations due to umbralisib-related AEs were limited with no discontinuations after 6 months due to a treatment-related AE and no deaths occurred on study.
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XENT | Hot Stocks16:10 EDT Intersect ENT published results provide clinical evidence supporting Sinuva use - Intersect ENT announced publication of a pooled analysis of the RESOLVE and RESOLVE II randomized controlled trials in the American Journal of Rhinology & Allergy. The results provide level 1a clinical evidence supporting the use of the SINUVA Sinus Implant for management of patients with recurrent nasal polyps in adult patients who have had previous ethmoid sinus surgery. The analysis included 375 patients with chronic sinusitis and nasal polyps who were candidates for revision endoscopic sinus surgery because of persisting symptoms of nasal obstruction/congestion and recurrent bilateral nasal polyps despite ongoing topical steroid therapy and a recent course of systemic steroids. The pooled analysis met all four efficacy endpoints, demonstrating a decrease in nasal obstruction/congestion score, bilateral polyp grade and ethmoid sinus obstruction at 90 days in SINUVA patients compared to the control group on MFNS alone. Additionally, results revealed a 59% reduction in the proportion of SINUVA patients who were still indicated for RESS at day 90 compared to a 31% reduction among patients in the control group. Only one patient experienced an implant-related serious adverse event.
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CRM | Hot Stocks16:09 EDT Salesforce CEO says 'I am thrilled with our results this quarter' - "I am thrilled with our results this quarter, and I am especially excited to have delivered record revenue in Q1 and operating cash flow of almost $2 billion, up 34% year-over-year," said Marc Benioff, chairman and co-CEO, Salesforce. "We have a massive opportunity in front of us and are well-positioned for long-term growth as the world's #1 CRM." "Our strong revenue growth in the quarter reflects the strength of our business and the tremendous demand we're seeing from customers worldwide," said Keith Block, co-CEO, Salesforce. "Companies of every size and industry are undergoing a digital transformation to better serve their customers and they are choosing Salesforce as their partner."
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OLP | Hot Stocks16:08 EDT One Liberty Properties acquires two industrial properties - One Liberty Properties announced that it acquired two industrial properties for an aggregate purchase price of $11.8M. On May 30, One Liberty acquired a 100,000 square foot industrial facility on 4.6 acres located three miles east of downtown Nashville, Tennessee, for $8M. The property is leased to two tenants with leases expiring in 2023 and 2024. The current aggregate annual base rent under the leases is $519,000, with annual increases ranging from 3.0% to 3.5%. On May 30, One Liberty acquired a 57,000 square foot industrial property on 3.1 acres located in Wauconda, Illinois, a suburb of Chicago, for $3.8M. The 32-foot clear, Class A building is net leased to Echo, Inc., a manufacturer and distributor of outdoor power and professional landscape equipment, and is used primarily for warehouse and distribution purposes. The lease provides for an annual base rent of $278,000, with 3% annual increases through lease expiration in early 2024.
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AQB | Hot Stocks16:04 EDT AquaBounty appoints David Melbourne Chief Commercial Officer - AquaBounty Technologies is pleased to announce the appointment of David F. Melbourne, Jr. as Chief Commercial Officer effective on June 17, and the commencement of the commercial production of AquAdvantage Salmon at the Company's Indiana farm.
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PTN | Hot Stocks16:03 EDT Palatin granted orphan status for chronic anterior uveitis treatment - The FDA granted Palatin Technologies orphan status for its treatment of non-infectious intermediate, posterior, pan, and chronic anterior uveitis. Reference Link
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H | Hot Stocks16:01 EDT Hyatt, Linblad form new loyalty collaboration - Hyatt Hotels Corporation announced that Hyatt and Lindblad Expeditions, a global provider of expedition cruises and adventure travel experiences, have formed a new loyalty collaboration that will provide World of Hyatt members with more unique ways to be rewarded for their loyalty beyond the traditional hotel stay. This new collaboration will give members the opportunity to immerse themselves in some of the world's wonders in hard-to-reach locations, all while earning and redeeming World of Hyatt points. This loyalty collaboration is expected to launch later this year. "Our members tell us they want to return from a trip having experienced something new. They see traveling as a way to experience other people, places and cultures and desire authentic, expansive and real-world experiences," said Amy Weinberg, senior vice president, World of Hyatt. "Through this new relationship with Lindblad Expeditions, World of Hyatt members will soon be able to enjoy even more personalized adventures and distinct, educational experiences that satisfy their desire to experience something new while enhancing their wellbeing and providing opportunities to discover rare parts of the planet - all while being specially rewarded with World of Hyatt loyalty benefits."
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GOOG GOOGL | Hot Stocks13:42 EDT Google to announce more details on game streaming service Stadia before E3 - Stadia said in a tweet: "Some news can't wait for #E3. Tune into the first ever #StadiaConnect this Thursday 6/6 at 9AM PT for exciting announcements, games, and more link: http://g.co/stadiaconnect) g.co/stadiaconnect" Reference Link
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NVS | Hot Stocks13:11 EDT Novartis says Tafinlar plus Mekinist show long-term survival benefits - Novartis announced results from the COMBI-d and COMBI-v clinical trials, concluding that first-line treatment with Tafinlar and Mekinist "offers both overall and progression-free long-term survival benefits to patients with unresectable or metastatic BRAF-mutation positive melanoma." Researchers reported that 34% of all patients in the pooled analysis who were treated with Tafinlar plus Mekinist survived at five years, the company said in a statement. Study authors also reported on prolongation in progression-free survival, with 19% of patients showing no sign of disease progression or death at five years, Novartis added. Five-year overall survival and PFS were similar in the pooled patient population. Of patients who achieved a complete response with Tafinlar plys Mekinist, 19% had five-year PFS and overall survival rates of 49% and 71%, respectively, compared with 19% and 34% in the overall population. Researchers also observed that the efficacy of subsequent treatment was preserved in patients who progressed on study treatment and subsequently received immune checkpoint inhibitor therapy, says the company.
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RETA | Hot Stocks13:03 EDT Reata Pharmaceuticals' bardoxolone methyl granted FDA orphan designation - Reata Pharmaceuticals' bardoxolone methyl was granted FDA orphan designation as a treatment of autosomal dominant polycystic kidney disease, according to a post to the agency's website. Reference Link
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FCAU RNSDF | Hot Stocks12:50 EDT Renault board 'to continue to study with interest' possible Fiat Chrysler merger - Renault (RNSDF) announced that its board of directors met today to review in detail the elements of the proposal received from Fiat Chrysler Automobiles (FCAU) on May 27 for a potential 50/50 merger between Renault S.A. and FCA. "The board of directors has decided to continue to study with interest the opportunity of such a combination and to extend the discussions on this subject. The board will meet again on Wednesday, June 5 at the end of the day," Renault stated.
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NEWT | Hot Stocks12:42 EDT Newtek Business Services raises 2019 annual dividend forecast to $1.90 per share - Newtek Business Services announced that it has increased its 2019 annual cash dividend forecast to $1.901 per share from a range of $1.85 per share to $1.86 per share, which would represent a 5.6% increase over the company's 2018 annual dividend payment of $1.80 per share. Barry Sloane, Chairman, President and CEO commented, "We are extremely pleased to increase our 2019 dividend forecast, our second increase this year, and maintain our goal of distributing approximately 90-100% of our taxable income for the year. Our performance continues to underscore our distinct business model, and we are proud of the continued growth in loan volume and referrals we are experiencing in the second quarter thus far, and continue to be comfortable with the creditworthiness of our loan portfolio. We are maintaining our full year 2019 SBA 7 loan fundings forecast of between $580M and $620M, which would represent a 27.9% increase, at the midpoint of the range, over SBA loan fundings for the year ended December 31, 2018."
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APC OXY | Hot Stocks12:36 EDT FTC approves Occidental Petroleum acquisition of Anadarko - The Federal Trade Commission posted on its website approval of Occidental Petroleum's (OXY) proposed acquisition of Anadarko Petroleum (APC). Reference Link
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PCMI MSFT | Hot Stocks12:02 EDT PCM to sell Microsoft cloud and licensing solutions to U.S. federal government - PCM, Inc (PCMI) announced that through its wholly-owned subsidiary PCMG, Inc. it has been authorized as a Microsoft (MSFT) Licensing Solution Provider, LSP, and Cloud Solution Provider, CSP,for the United States Federal Government. These credentials provide rights to sell Microsoft technology to the over $100B Federal IT market. "This authorization underscores our commitment to provide world-class technology, solutions and services to our Federal Government customer," said Frank Khulusi, Chairman and CEO of PCM. "Indeed, working with Microsoft, PCM-G continues its mission to assist today's defense and civilian agencies as they embrace transformational solutions such as data analytics, security and artificial intelligence." "Microsoft is pleased to partner with PCM in the Federal space. They have established market momentum within our CSP commercial platform and we look forward to their leadership as they deliver cloud software and services to this important segment," said David Smith, Vice President, US One Commercial Partner.
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KOOL | Hot Stocks12:02 EDT Cesca Therapeutics announces 1-for-10 reverse stock split - Cesca Therapeutics announced that it has amended its Sixth Amended and Restated Certificate of Incorporation to reflect a 1-for-10 reverse stock split of its common stock, which will be effective at 5:00 p.m. Pacific Time on June 4. The company expects that the split-adjusted shares of its common stock will begin trading on The Nasdaq Capital Market at the open of the market on June 5 under a new CUSIP number: 157131 301. No change will be made to the trading symbol for the company's common stock, "KOOL", in connection with the reverse stock split. The par value of the common stock will not be affected by the reverse stock split. The company's board implemented the reverse stock split with the objective of regaining compliance with the $1 minimum bid price requirement of The Nasdaq Capital Market. The company has until June 24 to comply with this requirement. To comply with this requirement, the closing bid price of the company's common stock must be at least $1 per share for a minimum of 10 consecutive business days prior to June 24. The company's stockholders approved the reverse stock split at the 2019 annual meeting of stockholders, which was held on May 30.
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V WU | Hot Stocks12:02 EDT Visa says will announce 'huge' Western Union collaboration tomorrow - In comments at the Bank of America Merrill Lynch Global Technology Conference, Visa's (V) Global Head of Push Payments Bill Sheley said that the company will announce a "huge" collaboration with Western Union (WU) tomorrow, noting that Western Union is looking at ways to reinvent their offering while Visa is looking to expand its reach. He said that Western Union will be a "fantastic" partner for Visa and that they have a great digital and mobile network. Sheley added that the card company has collaborated with Paytm in India over a service that allows you to pay your credit card out of your wallet. He also noted that all banks in Singapore have enabled users to push their credit card to pay their bills.
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BOX | Hot Stocks12:00 EDT Box falls -7.1% - Box is down -7.1%, or -$1.28 to $16.65.
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LXFR | Hot Stocks12:00 EDT Luxfer falls -8.7% - Luxfer is down -8.7%, or -$2.12 to $22.18.
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NETS | Hot Stocks12:00 EDT Netshoes falls -12.4% - Netshoes is down -12.4%, or -46c to $3.23.
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BBW | Hot Stocks12:00 EDT Build-A-Bear rises 12.9% - Build-A-Bear is up 12.9%, or 67c to $5.88.
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CLR | Hot Stocks12:00 EDT Continental Resources rises 14.7% - Continental Resources is up 14.7%, or $5.13 to $40.14.
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IO | Hot Stocks12:00 EDT ION Geophysical rises 18.1% - ION Geophysical is up 18.1%, or $1.32 to $8.63.
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PEGA | Hot Stocks11:33 EDT Pegasystems launches customer empathy controls for business - Pegasystems at PegaWorld introduced Customer Empathy Advisor, a new capability of Pega Customer Decision Hub that helps companies use AI to build more sustainable customer relationships. The feature allows organizations to increase the level of empathy in AI-assisted conversations so they can build more trust, loyalty, and value with each customer. "Most businesses are conditioned to try and squeeze every last drop of profit from each customer. But this predatory mentality distorts the fact that practicing a little empathy is not only good for the customer, it's good for business," said Dr. Rob Walker, vice president, decisioning and analytics, Pegasystems. "We've always believed that the only way to win a customer's heart is to first walk a mile in their shoes. Today we're taking a step closer in this pursuit by instilling empathy in customer interactions - which is ultimately the right way to do business for everyone."
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TDOC | Hot Stocks11:27 EDT Teladoc says 'ahead of plan,' selling season going 'really well' - Teladoc at the Jefferies 2019 Healthcare Conference said the selling season is going "really well." The company said, "We're ahead of plan and where we were last year." New and existing client bookings are also ahead of last year, Teladoc added. The stock is up 2.5% to $55.37 following this morning's presentation.
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TDOC | Hot Stocks11:16 EDT Teladoc expects to be cash flow positive in 2019 for first time - Teladoc made the comments earlier at a Jefferies conference.
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TDOC | Hot Stocks11:14 EDT Teladoc rallies $1.33 to $55.31 after comments at Jefferies conference
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ABBV | Hot Stocks11:13 EDT AbbVie presents data from CLL14 trial - AbbVie presented data from the CLL14 trial, the first randomized clinical trial to examine stopping an oral-based, chemotherapy-free combination after 12 months in previously untreated patients with CLL and coexisting medical conditions. The results demonstrate that venetoclax plus obinutuzumab prolonged progression-free survival, or PFS, and achieved higher rates of complete response and minimal residual disease-negativity compared to a commonly used standard of care obinutuzumab plus chlorambucil. These data were presented in an oral presentation at the American Society of Clinical Oncology, or ASCO, Annual Meeting in Chicago and were simultaneously published in the New England Journal of Medicine.
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CELG | Hot Stocks11:03 EDT Celgene announces data from ongoing studies of liso-cel - Celgene Corporation announced that data from the TRANSCEND CLL 004 and TRANSCEND NHL 001 trials studying the investigational anti-CD19 chimeric antigen receptor T-cell therapy lisocabtagene maraleucel in patients with B-cell blood cancers were presented at the American Society of Clinical Oncology Annual Meeting. The data included safety and efficacy findings from 23 patients who received liso-cel infusion at one of two dose levels: 50 106 or 100 106 total CAR-positive T cells following lymphodepleting chemotherapy. All patients had been previously treated with ibrutinib, and more than half had received prior venetoclax. The median number of lines of prior therapy was five and 83% of patients had high-risk cytogenetic features. In the study, 22 of 23 patients were evaluable for response. The best overall response rate was 82%, with 46% of patients achieving complete remission with or without complete blood count recovery. Of 20 patients evaluable for minimal residual disease, 75% achieved undetectable MRD by blood measures and 65% achieved uMRD by bone marrow measures. Responses have been durable, with 83% of patients who were in CR/CRi at six months post liso-cel infusion showing ongoing response.
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BA | Hot Stocks11:02 EDT Boeing invests in Robotic Skies - Boeing announced its investment in Robotic Skies, a services provider that connects manufacturers and operators of commercial unmanned aircraft systems, or UAS, with a global network of more than 170 civil aviation authority-certified repair stations. The investment is part of Boeing's long-term strategy of "entering into value-added partnerships that enhance and accelerate growth and deliver key differentiators for customers."
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DHXM | Hot Stocks10:39 EDT DHX Media up 21% after receiving unsolicted merger proposal
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DHXM | Hot Stocks10:37 EDT DHX Media confirms unsolicited merger proposal from Sakthi Global Holdings - DHX Media confirmed that it is aware of the announcement by Sakthi Global Holdings that it has made an unsolicited merger proposal to DHX Media. DHX Media has received communication of this proposal from Sakthi Global Holdings. At this time, Sakthi Global Holdings has not responded to questions from DHX Media and DHX Media has not been able to verify the ability of Sakthi Global Holdings to carry out a transaction. DHX Media's board will consider and evaluate any formal offer that is received in due course. There can be no certainty that a transaction will take place with Sakthi Global Holdings or any other party. DHX Media will update the market as warranted.
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ATV | Hot Stocks09:50 EDT Acorn International falls -9.7% - Acorn International is down -9.7%, or -$2.63 to $24.37.
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BOX | Hot Stocks09:50 EDT Box falls -11.5% - Box is down -11.5%, or -$2.06 to $15.87.
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NETS | Hot Stocks09:50 EDT Netshoes falls -16.6% - Netshoes is down -16.6%, or -61c to $3.07.
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LYB | Hot Stocks09:50 EDT LyondellBasell rises 6.5% - LyondellBasell is up 6.5%, or $5.05 to $82.74.
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CLR | Hot Stocks09:50 EDT Continental Resources rises 7.1% - Continental Resources is up 7.1%, or $2.47 to $37.48.
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DLPH | Hot Stocks09:47 EDT Delphi Technologies rises 7.4% - Delphi Technologies is up 7.4%, or $1.15 to $16.66.
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BDRBF | Hot Stocks09:26 EDT Bombardier, Hitachi Rail to supply 14 Frecciarossa 1000 trains to Trenitalia - Hitachi Rail and Bombardier, in a partnership expected to involve company participation of 60% and 40% respectively, will supply 14 Frecciarossa 1000 high-speed trains to Trenitalia, as well as a ten years maintenance service agreement for the new trains. The contract overall value is around $643M with the Bombardier share valued at $261M and the Hitachi share valued at 342 million euros ($382 million US). As with the current Frecciarossa 1000 fleet, all 14 of the new very high-speed trains will be built in Italy. Each train has a total length of around 200 meters, capacity for around 460 passengers and is capable of commercial speeds of up to 360 km/h.
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INO | Hot Stocks09:24 EDT Inovio CEO sold 2.2M shares to satisfy margin loan - In August 2014, Dr. J. Joseph Kim, Chief Executive Officer of Inovio Pharmaceuticals entered into a margin loan facility with a broker, in the amount of approximately $5M. The margin loan was initially collateralized by 1.0M shares of Inovio's common stock held by Dr. Kim, which amount increased over time to approximately 4.2M shares. Recently, due to declines in the share price, the broker called the margin loan and commenced selling the shares pledged as collateral in order to satisfy Dr. Kim's obligations. A total of 2,229,553 shares were sold between May 21 and June 3. The proceeds of such sales were used to fully satisfy the margin loan, and the remainder of the pledged shares will be released back to Dr. Kim. Therefore, Dr. Kim will hold his shares of Inovio "free and clear of this and any other pledge, and no additional share sales by or on behalf of Dr. Kim to meet the margin loan requirements are anticipated," Inovio said in a regulatory filing.
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BNED | Hot Stocks09:17 EDT Barnes & Noble Education, Jones & Bartlett Learning announce access agreement - Barnes & Noble Education announced a new agreement with Jones & Bartlett Learning. Through this agreement, eBooks from Jones & Bartlett Learning will be made available through inclusive access models offered on campuses served by BNED nationwide through its Barnes & Noble College and MBS subsidiaries.
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HPQ XRX | Hot Stocks09:15 EDT HP Inc., Xerox expand business relationship - HP Inc. (HPQ) and Xerox (XRX) announced an expansion of the companies' business relationship. Xerox will source from HP certain A4 and entry-level A3 products with the majority running on Xerox's award-winning ConnectKey controller software, and Xerox will supply toner to HP for these and other products. The printers will be based primarily on the laser printing technology HP acquired from Samsung in 2017. In addition, the companies have agreed to partner in the Device as a Service, or DaaS, market. "Xerox will become a DaaS specialist in HP's Partner First program in the U.S. Xerox's services capabilities and customer reach in the small to midsize business market, combined with HP's award-winning DaaS PC offerings, will allow both companies to meet a wider range of customer needs. Xerox will be authorized to sell HP PCs, displays and accessories to its commercial customers through DaaS. HP will also make Xerox's cloud-based content management platform DocuShare Flex available on its commercial PCs distributed in the U.S."
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PRPO | Hot Stocks09:14 EDT Precipio enters exclusive subcontracting manufacturing agreement with Novamed - Precipio announced that it has entered into an exclusive subcontracting manufacturing agreement with diagnostics manufacturing company Novamed for the production of Precipio's proprietary IV-Cell media for an initial term of 3 years. The agreement will provide Precipio with large-scale production volume of the media, enabling Precipio to provide cytogenetics laboratories in the U.S. and worldwide with IV-Cell media to meet their demand.
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MAT | Hot Stocks09:14 EDT Mattel announces international licensing agreement with Sanrio - Mattel announced an international licensing agreement with Sanrio. Through this new partnership, Mattel will design and develop a wide array of toys, dolls, playsets, games, puzzles, baby gear, plush, vehicles and other products inspired by Hello Kitty & Friends and Hello Kitty Cafe, as well as a range of characters in the Sanrio portfolio - including Hello Kitty, Keroppi, Chococat, Badtz-Maru, Little Twin Stars, Tuxedosam, Pompompurin, My Melody, Hangyodon, and Pochacco, among others. The toy lines and games will available in North America, Europe, Latin America, Australia and New Zealand beginning Fall 2020.
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AMZN | Hot Stocks09:13 EDT NASCAR selects AWS as preferred cloud computing provider - Amazon Web Services, an Amazon.com, announced that National Association for Stock Car Auto Racing, or NASCAR, has chosen AWS as its standard for cloud-based machine learning and artificial intelligence workloads. NASCAR will use the breadth and depth of AWS technologies to build cloud-based services and automate processes, including a new video series on NASCAR.com called This Moment in NASCAR History powered by AWS. "The video series will debut heading into the Monster Energy NASCAR Cup Series race at Michigan International Speedway, sharing the greatest historical moments in NASCAR racing with viewers. NASCAR is migrating its 18-petabyte video archive to AWS, and will leverage Amazon Rekognition-an AWS service that adds intelligent image and video analysis to applications-to automatically tag specific video frames with metadata, such as driver, car, race, lap, time, and sponsors so they can easily search those tags to surface the most iconic moments from past races. By using AWS's services, NASCAR expects to save thousands of hours of manual search time each year, and will be able to easily surface flashbacks like Dale Earnhardt Sr.'s 1987 "Pass in the Grass" or Denny Hamlin's 2016 Daytona 500 photo finish, and quickly deliver these to fans via video clips on NASCAR.com and social media channels."
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DTE | Hot Stocks09:11 EDT DTE Energy launches program of incentives to drive EVs adoption - DTE Energy on Tuesday announced its plan to bring the benefits of electric vehicles, or EVs, to more Michigan residents and businesses through its new "Charging Forward" program of incentives, customer education and charging infrastructure growth. Michigan is the nation's automotive center, but it lags many other states in EV adoption. DTE will provide a rebate of up to $500 to a residential customer who purchases or leases a new or used EV, installs a qualified Level 2 charger and enrolls in a special rate beneficial for EV charging. DTE's business customers can also receive incentives of $2,500 per port and $20,000 per charger when they install Level 2 or DC Fast Chargers.
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SNPS | Hot Stocks09:08 EDT Synopsys announces collaboration with Global Foundries to develop DesignWare IP - Synopsys announced its collaboration with Global Foundries to develop a broad portfolio of DesignWare IP, including Multi-Protocol 25G, USB 3.0 and 2.0, PCI Express 2.0, DDR4, LPDDR4/4X, MIPI D-PHY, SD-eMMC, and Data Converters, for GF's 12-nanometer Leading-Performance FinFET process technology. Synopsys' DesignWare IP on the GF 12LP process enables designers to implement the latest interface and analog IP solutions in their artificial intelligence, or AI, cloud computing, mobile, and consumer system-on-chip, or SoCs, on GF's 12LP technology, which delivers a 10% improvement in logic density and more than a 15 percent improvement in performance compared to previous FinFET generations. This collaboration is another extension to the long-standing relationship between the two companies, which has delivered DesignWare IP for GF's processes from 180-nm to 12-nm.
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UBER... | Hot Stocks09:05 EDT Fly Intel: Pre-market Movers - HIGHER: Uber (UBER), up after a number of analysts initiated shares with a Overweight or other Buy-equivalent ratings... Lyft (LYFT), up 3% after Citi analyst Itay Michaeli started the stock with a Buy rating and $70 price target... Sorrento Therapeutics (SRNE), up 5% after announcing that it has formed a Chinese joint venture, Shenzhen Yunma Biotechnology, with LifeTech Scientific to commercialize Sorrento's proprietary water soluble cannabidiol formulation technologies in Asia, excluding Japan... Fiat Chrysler (FCAU), up 3% after Reuters reported the company resolved differences with the French government as Renault (RNSDF) directors prepare to review the carmaker's $35B merger offer... LyondellBasell (LYB), up 2% after announcing it has ended discussions with Odebrecht concerning the potential acquisition of Braskem. UP AFTER EARNINGS: Coupa Software (COUP), up 7%... Tiffany (TIF), up 1%. DOWN AFTER EARNINGS: Box (BOX), down 15%. ALSO LOWER: Millicom (TIGO), down 10% after filing to sell 11M shares of common stock for holders... Ventas (VTR), down 3% after a 11M share spot secondary priced at $62.75 per share.
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EFX KO | Hot Stocks09:05 EDT Equifax appoints Amanda Rosseter as Chief Communications Officer - Equifax (EFX) has named Amanda Rosseter to its new Chief Communications Officer position, where she will lead corporate, executive and transformation communications, and will serve on the CEO's extended senior leadership team. Rosseter is a communications leader with more than 25 years in external communications and global media engagement. Most recently, she led global external communications and media for The Coca-Cola Company (KO), where she served in a number of roles, including Global Group Director of Strategic Communications and Public Affairs. Her accomplishments include leading the communications launch of a new business strategy to 17 business units across 200+ countries and territories as well as to media, external stakeholders and analysts.
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HAS | Hot Stocks09:03 EDT Hasbro and Wicked Cool toys enter into an agreement to sell Micro Machines toys - Hasbro entered into an agreement to appoint Wicked Cool Toys as global master toy licensee for Micro Machines. Wicked Cool Toys' portfolio includes original IP as well as the master toy licenses for top brands including Pokemon and Cabbage Patch Kids. Micro Machines, a top-selling line featuring collectable component style "playsets" and miniature vehicles, originally became a hit in the mid-1980s. The new line of Micro Machines is expected to hit store shelves in the fall of 2020.
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TIF | Hot Stocks09:02 EDT Tiffany says expects to 'make up ground' after 'tough' 1H
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DAL | Hot Stocks09:01 EDT Delta Air Lines reports May traffic up 7%, capacity up 5.3% - Load factor was up 1.3 pts to 87.6%.
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EYEN | Hot Stocks09:01 EDT Eyenovia enrolls first patient in Phase 3 CHAPERONE study - Eyenovia announced that it has initiated its MicroPine Phase 3 program with the first patient enrolled in its CHAPERONE study. The CHAPERONE study is a U.S.-based, multi-center, randomized, double-masked trial that will enroll more than 400 children between 3-12 years of age. The study will investigate the safety and efficacy of MicroPine for the reduction of progressive myopia using Eyenovia's proprietary atropine topical micro-formulation delivered by the Optejet dispenser. Subjects will be randomized to receive treatment with either of two MicroPine concentrations or a placebo. The primary endpoint of the study is the change in refractive error from baseline through 36 months.
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CR CIR | Hot Stocks09:00 EDT Crane reiterates proposal to enter acquisition talks with Circor - Crane (CR) sent a letter to the board of CIRCOR International (CIR) in which Crane reaffirmed its desire to enter into "meaningful discussions" regarding a transaction that would provide a "significant premium" for CIRCOR shareholders. This letter follows the CIRCOR board's rejection of Crane's initial $45 per share all-cash proposal without comment or discussion. CIRCOR shareholders have "expressed strong support for engagement and frustration with status quo following Crane's May 21 Investor Call." The proposal presents "a compelling opportunity" for CIRCOR shareholders to realize "immediate and certain value." Crane is willing to adjust the price in the proposal if CIRCOR management "engages" with the company and "provides sufficient justification."
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OBLN | Hot Stocks08:58 EDT Obalon Therapeutics announces issuance of patent for Obalon Navigation System - Obalon Therapeutics announced the issuance of U.S. Patent No. 10,264,995. The Obalon Navigation System provides the treating physician with the ability to place the Obalon Balloon without having to incur the costs of utilizing x-ray imaging. The newly issued patent covers multiple aspects of the Obalon Navigation System, including dynamic tracking using internal and external sensors with an external electromagnetic field.
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TIF | Hot Stocks08:48 EDT Tiffany says impacted by declines in foreign tourist spending, higher tariffs
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MXL | Hot Stocks08:47 EDT MaxLinear backs Q2 GAAP gross margin guidance of 53%-54% - Backs Q2 GAAP operating expenses of $49M-$49.5M. Backs Q2 non-GAAP gross margin guidance of 63.5%-64.5%. Backs Q2 non-GAAP operating expenses of $33M-$33.5M.
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TIF | Hot Stocks08:44 EDT Tiffany says Q1 results not indicative of longer-term earnings power
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ATIS SUN | Hot Stocks08:44 EDT Attis Industries ethanol plant expected to generate over $150M in revenue - Attis Industries (ATIS) announced that its recently acquired corn ethanol plant in Fulton, NY is expected to generate over $150M in revenue under its current operating conditions. This corn ethanol plant is just the base platform for the company's strategic plan to develop a green tech campus in Fulton, NY. Attis announced it had finalized the $20M purchase of Sunoco (SUN) nameplate 100M gallon per year corn ethanol plant and grain malting operation in Fulton, NY. The acquisition provides the company with an operational asset that produces revenue immediately and will be the centerpiece of its proposed green tech campus. In addition to the ethanol produced, the Fulton facility is producing or capturing about the following on an annual basis: 360M pounds of CO2 for sale into food, beverage or industrial applications, 455M pounds of DDGS for use in animal feed, 18M pounds of distillers corn oil for use as a feedstock in biodiesel and animal feed and 4M pounds of malted grain. Beyond these operational capabilities, Attis has identified several projects at the site that will enhance the profitability and overall production capacity of the site and create roughly 100 jobs. Tapping into its portfolio of proprietary biobased process technologies, Attis will focus on byproduct optimization of the corn ethanol plant and the new production of advanced biofuels and biobased products such as bioplastics and carbon fiber. Attis will also look to generate "green" power, thus reducing the overall carbon footprint of the Fulton campus and taking advantage of valuable carbon credits to increase the site's profitability.
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INS | Hot Stocks08:42 EDT Intelligent Systems says 'factual errors, erroneous conclusions' in short report - Intelligent Systems stated in a press release last night: "On May 24 and May 30, 2019, separate commentaries about Intelligent Systems Corporation were released by Aurelius Value and Grizzly Reports. The anonymous authors never contacted the company for clarifications or answers to any questions they may have. Had they done so, Intelligent Systems would have pointed out factual errors, incomplete information and erroneous conclusions which are rebutted by Intelligent Systems' public filings and other publicly available information...We believe it is in the best interest of our shareholders for management to remain focused on business rather than debating or responding to rumor and innuendo. However, due to the number of inquiries to the company, management believes it important to now respond to these misrepresentations. It is also important for interested parties to consider that the individuals responsible for the 'short and distort' reports have a financial interest in a decline in the company's stock price. We believe this calls into question the motivation and intent behind the allegations as well as the timing of its release." Intelligent Systems management plans to host an investor conference call on Wednesday June 5, 2019 at 11 am Eastern Time to discuss "corporate developments and to address the false and misleading statements and innuendo in the above-mentioned commentaries," the company noted.
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CETX | Hot Stocks08:40 EDT Cemtrex announces final court approval of settlements in lawsuits - Cemtrex announced that the court has approved the previously announced settlements in the alleged securities class action lawsuit and related shareholder derivative litigations, filed in the Eastern District of New York and New York state court. Under the class action settlement, the company specifically denies any liability or that it has engaged in any wrongdoing. On behalf of the defendants, the company's insurer will pay $625,000 to the class of plaintiffs to resolve all claims asserted or could have been asserted in the litigation. Under the derivative litigation settlement, the company and the directors and officers of the company named as defendants also deny any liability or wrongdoing in connection with the allegations contained in the lawsuit. The terms of the settlement require the company to implement certain corporate governance changes and modify certain governance practices, and the company's insurer will pay $100,000 to the plaintiffs' counsel. Like the class action settlement, the derivative litigation settlement resolves all claims that were or could have been asserted in the litigations.
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TIF | Hot Stocks08:38 EDT Tiffany: External pressures 'significantly' impacted sales in Q1 - Says results have not been up to long-term growth standards. Says external pressures significantly impacted sales in the quarter. Comments taken from the Q1 earnings conference call. Tiffany & Co shares are down 2.7% in pre-market trading.
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HTZ | Hot Stocks08:37 EDT Hertz announces vehicle-subscription service - Hertz announced a vehicle-subscription service that will give customers even more flexibility and freedom with their transportation needs. Hertz My Car, which is available in Atlanta, Georgia and Austin, Texas, will give customers access to Hertz's best fleet ever, including a diverse range of sedans, crossovers, SUVs and trucks through a convenient, all-inclusive monthly subscription. Hertz will offer two tiers of the program to best suit customers' preferences.
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GLW | Hot Stocks08:37 EDT Corning registers two radiation-shielding glass products with FDA - Corning announced that two of its products, Corning Med-X Glass and Corning Med-Gamma Glass, are now registered as compliant with FDA regulations.
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LGL | Hot Stocks08:37 EDT LGL Group pursuing development of A&D industry operating, advisory platforms - The LGL Group announced that management and its board are pursuing the development of aerospace and defense industry operating and advisory investment platforms in an effort to enhance shareholder value. "The LGL Group expects to build several A&D verticals through the introduction of industry focused partnerships and special purpose vehicles formed to make targeted acquisitions. This effort will seek to leverage the core competencies of the company's management and board of directors. The company would act as the financial and management sponsor, raise capital from external nonaffiliated investors, and would receive management fees and success-based incentives in accordance with market practice. The company cautions shareholders and others that there can be no assurance that the foregoing business platform will be executed, or that any transaction will be approved by the board, consummated, or if consummated, as to the timing thereof." The company's board may also decide to pursue other strategic alternatives with its balance sheet, which may take the form of potential business acquisitions or combination opportunities. The company is unable to project in any manner the course of action to be pursued in such circumstances and whether such opportunities will be available, and if available and successfully pursued, the company thereafter will be subject to future risks and uncertainties associated with such opportunities which are unknown at this time.
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CLBS | Hot Stocks08:36 EDT Caladrius completes enrollment in Phase 2 ESCaPE-CMD trial in CMD - Caladrius Biosciences announced the completion of enrollment and dosing in the Phase 2 ESCaPE-CMD study for CLBS16 in patients with coronary microvascular dysfunction. The company expects to announce topline results shortly after the last patient completes follow up at the end of 2019. This Phase 2 interventional, open label, proof-of-concept study was conducted at two centers in the United States, Cedars-Sinai in Los Angeles, CA and the Mayo Clinic in Rochester, MN. In the study, 20 patients with diagnosed CMD received CLBS16 via a routine intracoronary infusion. The safety and efficacy endpoints include changes from baseline to six months for coronary flow reserve, or CFR, endothelial-dependent microvascular function, time to angina and other cardiovascular metrics. The company said in a statement: "Preliminary results from the first 30% of the patients to complete the 6-month follow-up are highly promising with evidence that improved CFR is associated with symptomatic improvement. The results from this study are particularly important because they may provide information as to the impact of CLBS16 on patients with CMD while also providing potential corroboration of the mechanism of action of CD34+ cells in humans of promoting the growth of new microvasculature in response to myocardial ischemia. We will also look to these results for further support for the proposed mechanism of action of CLBS14 in no option refractory disabling angina, an indication for which Caladrius is preparing to commence a registration Phase 3 study."
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PGNX | Hot Stocks08:36 EDT Velan Capital urges Progenics' stockholders to vote Green proxy card - Velan Capital, one of the largest stockholders of Progenics Pharmaceuticals, issued the following statement responding to certain misleading claims made by Progenics in its recent letter to stockholders. Letter began "On June 3 the Progenics Board of Directors delivered a letter to "fellow shareholder[s]" touting a commitment "to enhancing the value of [their] investment" yet the non-executive directors collectively own only ~0.06% of Progenics common stock with Peter Crowley and Michael Kishbauch owning ZERO shares of Progenics common stock. It seems apparent to us that with so little 'skin in the game' and not enough confidence in the Company to engage in meaningful stock purchases, the Board does not have the same commitment to stockholder value as we do. Rather, the Board and the Compensation Committee of the Board, of which Messrs. Crowley and Kishbauch are the sole members, seem committed to awarding poor performance with hefty paydays." Letter ended: "The Board has failed patients and stockholders for too long - change must occur to see better results. The Company's slogan is "Find, Fight, and Follow" - we urge stockholders to "Find" the status quo unacceptable, "Fight" years of value destruction and squandered opportunities, and "Follow" our call to action by voting AGAINST the re-election of Messrs. Crowley and Kishbauch on the GREEN proxy card. It is time for accountability at Progenics - Velan urges all stockholders to vote for change on the GREEN proxy card!"
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FLDM | Hot Stocks08:35 EDT Fluidigm announces Andrew Quong as CSO - Fluidigm announced that Andrew Quong has joined the company as its first-ever chief science officer, or CSO. Quong will lead the company's strategy for the generation of scientific insights in immunology, immuno-oncology and other frontiers of human health based on Fluidigm technology. He will develop and integrate Fluidigm's science and technology as it supports the advancement of knowledge in health and disease within the broader business strategy. Quong was most recently director of strategic scientific initiatives and partnerships at the Frederick National Laboratory for Cancer Research, a federally funded research and development center sponsored by the National Cancer Institute.
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AITB | Hot Stocks08:34 EDT AIT Therapeutics announces $8M PIPE financing - AIT Therapeutics announced that it has successfully executed funding agreements to raise $8M through a private investment in public equity, or PIPE, financing. AIT will issue 1.6 million unregistered shares of common stock to investors at a purchase price of $5.00 per share. Proceeds from the raise will be used to continue development of the company's three indications: Persistent Pulmonary Hypertension of the Newborn, Bronchiolitis, and Nontuberculous mycobacteria, as well as for general corporate purposes. Steve Lisi, Chairman and CEO of AIT, said: "This transaction will provide the funds needed to achieve our goals over the next 12 to 15 months of a PMA submission/FDA approval decision for PPHN, completion of our bronchiolitis trial this winter and the commencement of our at-home study in patients suffering from NTM lung infection."
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BMRN | Hot Stocks08:32 EDT BioMarin announces NMPA approval of Vimizim - BioMarin announced that Vimizim has been approved by the National Medical Products Administration for the treatment of patients with mucopolysaccharidosis type IVA, also known as Morquio A syndrome. Vimizim is the first treatment in China approved for this condition.
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TBPH | Hot Stocks08:32 EDT Theravance Biopharma appoints Andrew Hindman as CFO - Theravance Biopharma announced the appointment of Andrew Hindman as Senior Vice President and CFO. Hindman brings nearly 25 years of life science industry experience spanning a broad range of functional areas including corporate strategy, finance, business development, operations, public policy and marketing. Importantly, he possesses broad therapeutic expertise and has established a strong track record of long-term value creation at several high-profile life science companies including Gilead Sciences, Acorda Therapeutics and Onyx Pharmaceuticals. Hindman has held several senior executive level positions in the biopharmaceutical industry, most recently as Chief Business Officer of Acorda Therapeutics. In this role, he led Acorda's acquisitions of Civitas Therapeutics and Biotie Therapies, helping transform the business from a single product business to a specialty neurology biotechnology company.
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OXY APC | Hot Stocks08:23 EDT Occidental Petroleum announces early termination of SR waiting period - Occidental Petroleum(OXY) announced that on June 3, the U.S. Federal Trade Commission granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, with respect to the pending acquisition of Anadarko Petroleum (APC). The termination of the waiting period under the HSR Act satisfies one of the conditions to the closing of the pending acquisition, which remains subject to other customary closing conditions, including approval from Anadarko's stockholders. The acquisition is expected to close in the second half of 2019.
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CO | Hot Stocks08:23 EDT Global Cord Blood receives acquisition proposal from Cordlife - Global Cord Blood announced that its board of directors has received a non-binding proposal letter from Cordlife Group, pursuant to which Cordlife proposes to combine the businesses of Cordlife and the Company, by way of a statutory merger. Cordlife will issue its ordinary shares at an issue price of SGD0.5 per ordinary share in exchange for all of the outstanding ordinary shares of the company at $7.50 per ordinary share. According to the proposal letter, which is dated June 4, Cordlife would issue approximately 2,497.9 million ordinary shares in exchange for all of the outstanding shares of the Company. Upon completion of the proposed transaction, the Company's ordinary shares will be delisted from the New York Stock Exchange and the Cordlife ordinary shares will continue to trade on SGX. Completion of the proposed transaction is subject to various conditions, including but not limited to, satisfactory completion of due diligence, approval by the board of directors and shareholders of Cordlife and the Company, applicable regulatory approvals and other customary conditions. The company expects that its board of directors will form a special committee of independent directors to consider the proposed transaction. The company also expects that the Special Committee will retain advisors, including an independent financial advisor and legal counsel, to assist it in its work. The company cautions its shareholders and others considering trading its ordinary shares that no decisions have been made with respect to the company's response to the proposed transaction. The proposed transaction is still subject to various conditions, including but not limited to, completion of due diligence, parties entering into definitive agreement, and/or each of Cordlife and the company obtaining its relevant regulatory and shareholders approval. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that this or any other transaction will be approved or consummated.
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ADT | Hot Stocks08:21 EDT ADT Inc. awarded $4M in lawsuit against Alder Holdings - ADT announced that the company was awarded $3M in compensatory damages and $1M in punitive damages against Alder Holdings, a Utah-based company. ADT filed an unfair competition lawsuit against Alder for deceptive sales practices. The jury in the case returned a verdict in favor of ADT, finding that Alder engaged in, and was liable for, deceptive sales practices that misled hundreds of ADT customers. The case was tried in May in the U.S. District Court for the Southern District of Florida.
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CO | Hot Stocks08:20 EDT China Cord Blood receives acquisition proposal from Cordlife Group - Global Cord Blood announced that its board of directors has received a non-binding proposal letter from Cordlife Group, pursuant to which Cordlife proposes to combine the businesses of Cordlife and the Company, by way of a statutory merger. Cordlife will issue its ordinary shares at an issue price of SGD0.5 per ordinary share in exchange for all of the outstanding ordinary shares of the company at $7.50 per ordinary share. According to the proposal letter, which is dated June 4,, Cordlife would issue approximately 2,497.9 million ordinary shares in exchange for all of the outstanding shares of the Company. Upon completion of the proposed transaction, the Company's ordinary shares will be delisted from the New York Stock Exchange and the Cordlife ordinary shares will continue to trade on SGX. Completion of the proposed transaction is subject to various conditions, including but not limited to, satisfactory completion of due diligence, approval by the board of directors and shareholders of Cordlife and the Company, applicable regulatory approvals and other customary conditions. The company expects that its board of directors will form a special committee of independent directors to consider the proposed transaction. The company also expects that the Special Committee will retain advisors, including an independent financial advisor and legal counsel, to assist it in its work. The company cautions its shareholders and others considering trading its ordinary shares that no decisions have been made with respect to the company's response to the proposed transaction. The proposed transaction is still subject to various conditions, including but not limited to, completion of due diligence, parties entering into definitive agreement, and/or each of Cordlife and the company obtaining its relevant regulatory and shareholders approval. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that this or any other transaction will be approved or consummated.
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ATI | Hot Stocks08:19 EDT Allegheny Technologies announces sale of titanium Cast Products business - Allegheny Technologies announced it has reached a definitive agreement to sell its Cast Products business to Consolidated Precision Products, or CPP, of Cleveland, OH. CPP operates 16 global facilities manufacturing products primarily for the aerospace, defense and industrial industries and is a portfolio company of Warburg Pincus, a leading global private equity firm. The transaction, subject to customary regulatory approvals, is expected to close in the early part of the third quarter 2019. The gross cash proceeds will be used to further ATI's capital deployment priorities, principally focused on improving its balance sheet by reducing corporate debt levels and funding its pension obligations, as well as building its strategic cash reserves over time. ATI's third quarter 2019 results will likely include a modest gain from this transaction.
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FOMX | Hot Stocks08:19 EDT Foamix announces publication of Phase 3 FX2017-22 study - Foamix announced the peer review publication of the Phase 3 study FX2017-22 in the Journal of the American Academy of Dermatology, or JAAD. Study 22 was conducted by Foamix to support the new drug application, or NDA, submission of FMX101, which is currently under review by the FDA for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients nine years of age and older. The study showed statistically significant superiority of FMX101 compared with vehicle in both primary endpoints of absolute inflammatory lesion reduction and IGA treatment success at week 12. FMX101 also met all secondary endpoints, showing statistically significant improvement in absolute reductions in both inflammatory lesions and non-inflammatory lesions. There was a statistically significant reduction in inflammatory lesions versus vehicle as early as week 3 of treatment, and all subsequently assessed timepoints throughout the entire treatment course of the study. Statistically, participants were no more likely to experience treatment-emergent adverse events, or TEAEs, from FMX101 than from vehicle treatment. The majority of TEAEs were mild to moderate. More than 95% of participants using FMX101 had no or mild skin tolerability scores at the treatment application site at week 12.
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AQST | Hot Stocks08:14 EDT Aquestive Therapeutics completes enrollment in PK trial for Libervant - Aquestive Therapeutics announced it has completed enrollment in a single dose crossover pharmacokinetic, or PK, trial for Libervant, or diazepam buccal film, which is in development for the management of select patients with refractory epilepsy who require treatment to control episodes of increased seizure activity, or "seizure clusters." The Company also initiated a rolling New Drug Application, or NDA, submission for Libervant in May with the FDA. The single dose crossover study is designed to compare Libervant and its reference listed drug, Diastat Rectal Gel, in the same patient population, and provide the final set of data validating the Libervant dosing model.
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VERU | Hot Stocks08:13 EDT Veru adds VERU-100 to prostate cancer drug development pipeline - Veru announced that it has added to its prostate cancer drug development pipeline, a proprietary biologic drug candidate, VERU-100, for the treatment of hormone sensitive advanced prostate cancer. VERU-100 was internally developed in collaboration with Drug Delivery Experts. The company recently met with the FDA and received agreement that VERU-100 qualifies for an expedited regulatory pathway. Based on FDA input, the company plans to commence a single open label, multicenter dose-finding Phase 2 clinical trial in approximately 50 men, followed by a single open label, multicenter Phase 3 clinical trial in approximately 100 men. Veru is in the process of scaling up GMP manufacturing of drug product to prepare for the clinical trials of VERU-100. The company plans to submit an investigational new drug application by no later than calendar Q1 2020. Based on current cash on hand and expected cash from current sales forecasts, along with existing sources of capital, the company does not anticipate the need for a new equity financing until at least FY21, even with additional costs related to the VERU-100 clinical development.
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SOLY | Hot Stocks08:12 EDT Soliton announces results from preclinical studies of new pulse technology - Soliton announced results of preclinical studies of the use of a new version of its acoustic pulse technology which reveal its RAP device appears to be capable of selective disruption of the fibrotic septa that contribute to the appearance of cellulite. The new discovery, referred to as "acoustic subcision," helps explain the recent proof-of-concept trial results showing an improvement in the appearance of cellulite following use of the Company's RAP device. Together with the device's demonstrated ability to stimulate new collagen production in animal models, this represents what the Company believes is a potentially important new way to treat cellulite and improve the appearance of the skin. The RAP device for the treatment of cellulite is investigational and not available for sale in the U.S.
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OSB | Hot Stocks08:11 EDT Norbord says OSB mill in High Level, Alberta resumes production - Norbord reported that its OSB mill in High Level, Alberta resumed production earlier this week after the evacuation order for the town of High Level was lifted. On May 21st, Norbord reported that its OSB mill in High Level had temporarily suspended production in order to comply with evacuation orders due to wildfires burning in the region. All non-essential mill employees were safely evacuated at the time and the mill did not incur any damage. The curtailment is not expected to materially impact Norbord's second quarter results. The High Level, Alberta mill has a stated annual production capacity of 860M square feet and has been ramping up toward full production since resuming operations in late 2013. High Level is located approximately 720 kilometres northwest of Edmonton and 400 kilometres west of Fort McMurray.
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CSIQ | Hot Stocks08:10 EDT Canadian Solar subsidiary signs PPA with Energy Transfer - Canadian Solar announced that its wholly owned subsidiary Recurrent Energy has signed a power purchase agreement, or PPA, with Dallas-based Fortune 100 oil and gas pipeline company, Energy Transfer. This PPA represents Energy Transfer's first-ever dedicated solar contract. The 40 MWp/28 MWac power contract signed with Energy Transfer for solar energy from the Maplewood 2 project has a duration of 15 years.
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OOMA | Hot Stocks08:10 EDT Ooma surpasses 1M core subscribers - Ooma announced users of the company's core subscription services now total more than 1M. Additionally, Ooma customers have saved more than $2B since the company began offering cloud-based communications service in 2007, based on estimated cost reductions when customers switch away from traditional landline providers. With more than 1M core users and almost one million users of the mobile-only Talkatone app, Ooma now serves nearly 2M users in total.
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ASLN | Hot Stocks08:10 EDT Aslan Pharmaceuticals completes Phase 1 study for ASLAN004 in atopic dermatitis - ASLAN Pharmaceuticals announced the completion of its single ascending dose study testing the first-in-class therapeutic antibody ASLAN004 in healthy volunteers, and the updated data from the second part of the study that tested a subcutaneous formulation of ASLAN004. ASLAN004 is a fully human monoclonal antibody that binds to the IL-13 receptor alpha1 subunit, blocking signalling of two pro-inflammatory cytokines, IL-4 and IL-13, which are central to triggering symptoms of atopic dermatitis, such as redness and itching of the skin. ASLAN reported interim results from the first part of the study, which tested ASLAN004 administered intravenously, in March 2019. Data from the second part of the study showed that ASLAN004 was well tolerated at all doses when administered subcutaneously. There were no adverse events that led to discontinuations and only one case of mild itch as an injection site reaction, which resolved within 24 hours. Analysis of downstream mediators including phosphorylation of STAT6, a critical mediator of allergic inflammation, demonstrated complete inhibition within one hour of dosing and a pharmacokinetic profile that suggests ASLAN004 could target a once monthly dose regimen. Notably, it was observed that the trough level of ASLAN004 required to completely inhibit signal transduction via the receptor was over an order of magnitude lower than that of existing therapies. The data follows ASLAN's announcement on May 31 that it had amended its agreement with CSL to acquire global rights to develop, manufacture and commercialise ASLAN004. As a next step, ASLAN expects to initiate a multiple ascending dose study in moderate to severe atopic dermatitis patients in the second half of 2019.
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VBIV | Hot Stocks08:09 EDT VBI Vaccines says VBI-1901 'well tolerated' at all doses in Phase 1/2a study - VBI Vaccines presented a poster on Sunday, June 2, 2019, at the American Society of Clinical Oncology Annual Meeting that exhibited expanded clinical data from Part A of the Phase 1/2a study of VBI-1901 in recurrent Glioblastoma patients. The poster presented data on a total of 18 patients enrolled in Part A of the study, which was a multi-center, open-label, dose-escalation study across three dose cohorts of VBI's vaccine immunotherapeutic, VBI-1901 - 0.4 microg, 2.0 microg, and 10.0 microg. Part A was designed to evaluate the safety and tolerability of VBI-1901, and to define the optimal immunogenic dose level to test in the Part B extension phase of the study, which is expected to initiate enrollment mid-year 2019. Part B of the trial will further assess immunologic responses and potential correlations with tumor and clinical responses. Highlights from Poster Presentation: The vaccine immunotherapeutic was well-tolerated at all doses, with no safety signals observed Grade 2, 3, or 4 adverse events occurred in 66%, 22%, and 11% of participants, respectively - none were related to the vaccine immunotherapeutic. Six patients immunologically responded to VBI-1901, with evidence of robust boosting of cytomegalovirus-specific immune responses against both glycoprotein B and pp65 antigens. Median progression-free survival was longer among responders vs. non-responders. Three out of six patients in the high-dose, 10 microg, cohort had evidence of stable disease by magnetic resonance imaging, compared to one out of six in the low-dose cohort and zero out of six in the intermediate-dose cohort. The company said the 10 microg dose selected for Part B of the study, which is expected to initiate enrollment mid-year 2019.
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ATNM | Hot Stocks08:08 EDT Actinium Pharma presented new data from pivotal Phase 3 SIERRA study of Iomab-B - Actinium Pharmaceuticals presented new data from the ongoing pivotal Phase 3 SIERRA study of Iomab-B's single agent effect in patients with active, relapsed or refractory AML or Acute Myeloid Leukemia age 55 and above. The data was presented by SIERRA investigator Benjamin Tomlinson, M.D., Adult Hematologic and Stem Cell Transplant Section, Seidman Cancer Center, University Hospitals Case Medical Center in a poster presentation at the 2019 ASCO or American Society of Clinical Oncology Annual Meeting that is being held from May 31st - June 4th at the McCormick Place, Chicago.
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PHG | Hot Stocks08:08 EDT Philips announces 10-year strategic partnership with UVM Health Network - Philips and the University of Vermont, or UVM, Health Network announced a long-term, strategic partnership of 10 years. The partnership, which extends an existing relationship between the two organizations, will help support staff in providing care and advance efforts to improve the health of the population in Vermont and northern New York. Connecting the UVM Health Network with Philips imaging systems, ultrasound, patient monitoring and clinical informatics, the partnership will offer a range of clinical and business solutions and consulting services. These technologies and services will help the UVM Health Network better integrate workflows for a more seamless patient experience.
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NK | Hot Stocks08:07 EDT NantKwest announces 'durable CR' after off-the-shelf aNK therapy - Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest presented a clinical data update in patients who have received off-the-shelf aNK and/or haNK natural killer cell therapy in combination with immunotherapeutic agents in advanced solid tumors. These results demonstrated durable complete responses in 5 out of 35 patients with highly refractory late stage cancers across multiple tumor types. Data presented at the Jefferies Healthcare Conference demonstrated complete responses across phase I combination studies of aNK/haNK with or without N-803, ImmunityBio, Inc.'s IL-15 fusion superagonist in solid tumor cancer patients with highly refractory disease. ImmunityBio, is an affiliated company of NantKwest. These combinations enhance NK and T cell activity and proliferation, and resulted in 14% complete responses across multiple indications, while demonstrating positive safety profiles. In patients with highly refractory and relapsed diseases who have failed multiple rounds of standard-of-care therapy, the responses were durable. All five patients with complete responses remain alive to date, ranging from 4 to 24 months from the onset of response.
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ALNA | Hot Stocks08:06 EDT Allena says 'substantial' treatment effect observed in reloxaliase study - Allena Pharmaceuticals announced interim data from Study 206, its Phase 2 basket clinical trial of reloxaliase, an orally-administered, recombinant oxalate-degrading enzyme. Study 206 includes adult and pediatric patients suffering from the progression of primary hyperoxaluria or enteric hyperoxaluria with advanced chronic kidney disease, both of which can lead to systemic oxalosis, a potentially life-threating condition. Consistent with Allena's prior clinical experience, EH patients treated with reloxaliase in Study 206 demonstrated a substantial treatment effect. This includes EH patients with advanced CKD, a patient population not previously treated with reloxaliase, who showed reductions in urine oxalate and plasma oxalate. Allena plans to present detailed results at the OHF International Hyperoxaluria Workshop, June 21-22, 2019 in Boston, MA. The first seven patients have completed treatment, including one EH patient with advanced CKD, one EH patient with a functioning kidney transplant and two patients with EH who are on dialysis. Three patients had PH and preserved renal function. All four patients with EH experienced a reduction in POx, with an average reduction of 40% compared to baseline. The two patients not on dialysis also experienced reductions in UOx of 29% and 42%, respectively. The treatment effect observed in these EH patients supports a continued focus on treating EH patients with CKD, kidney transplantation or dialysis dependence in an effort to reduce further oxalate damage. Three patients with PH type 2 or PH type 3 with preserved renal function were treated. These are the first patients with any form of PH treated with reloxaliase. One patient had a greater than20% mean reduction in UOx excretion, while the other two patients did not show a response to reloxaliase. Allena intends to narrow its further evaluation of reloxaliase in PH to patients with compromised renal function where the GI mechanism of action may play a more important role. This trial encompasses the longest reloxaliase treatment duration thus far. All patient populations are being treated for three months with more frequent dosing of reloxaliase than the company's prior Phase 2 studies. Average patient dosing compliance was greater than 90%. Treatment with reloxaliase was well-tolerated in all patient populations, with no reported treatment-related serious adverse events.
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CSIQ | Hot Stocks08:04 EDT Canadian Solar subsidiary signs PPA with Anheuser-Busch - Canadian Solar announced that its wholly owned subsidiary Recurrent Energy, has signed a 15-year power purchase agreement, or PPA, with Anheuser-Busch for 310 MWp/222 MWac of electricity from its Maplewood solar project. This landmark contract is the seventh largest commercial and industrial power purchase agreement for solar energy signed in the entire world to date, according to data supplied by Bloomberg New Energy Finance. The PPA, which marks the early achievement of Anheuser-Busch's 2025 Renewable Electricity goal in the U.S., also represents the U.S. beverage industry's largest single purchase of solar energy.
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CBRL | Hot Stocks08:03 EDT Cracker Barrel announces $50M share repurchase program - The share repurchase authorization is effective immediately and replaces the prior authorization.
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CACI | Hot Stocks08:03 EDT CACI CEO Ken Asbury to retire, COO John Mengucci to succeed as CEO - CACI International announced that Ken Asbury will retire as CACI's President and CEO and as a director effective June 30. CACI's board has elected John Mengucci, currently the company's COO, to succeed Asbury as President and CEO effective July 1. The board has also elected Mengucci to serve as a member of the board, effective July 1. Asbury, in accordance with personal plans, will retire from CACI later this year.
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CBRL | Hot Stocks08:03 EDT Cracker Barrel declares special dividend of $3.00 per share - The Board of Directors declared a special dividend of $3.00 per share on the company's common stock. This is the company's fifth special dividend declaration. The special dividend will be payable on August 2 to shareholders of record on July 19.
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CBRL | Hot Stocks08:02 EDT Cracker Barrel raises quarterly dividend 4% to $1.30 from $1.25 per share - The quarterly dividend is payable on August 5 to shareholders of record on July 19.
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NK | Hot Stocks08:01 EDT NantKwest partner presents updated nanatinostat data at ASCO - NantKwest announced that its strategic partner Viracta Therapeutics presented updated clinical data on its HDAC inhibitor, nanatinostat at the Annual Meeting of the American Society of Clinical Oncology in Chicago, IL, from May 31-June 4. In April 2017, NantKwest announced that it was the lead investor in Viracta's Series B financing round. Concurrent with the financing, NantKwest secured an exclusive license with commercialization rights to nanatinostat for use in combination with natural killer, or NK, cell therapies, including NantKwest's NK cell platforms. Nanatinostat is a Class 1 histone deacetylase, or HDAC, inhibitor currently in phase Ib/II clinical trials. In preclinical studies, nanatinostat has been shown to reactivate silenced transgenes in tumor cells thereby turning them into preferential targets for NK cell killing, while also serving to broadly stimulate a patient's immune system, offering the potential for improved clinical responses in cancer patients. The activity of HDAC inhibitors are believed to be based on the upregulation of natural killer group 2D ligand expression on cancer cells, which serve as "eat-me" signals for NK cells and can drive NK proliferation, activation and cancer cell killing. NantKwest is preparing to initiate clinical trials that include nanatinostat in combination with its haNK and t-haNK cell therapy platforms, which we believe will work synergistically to enhance the efficacy of the company's NK cell therapies and further distinguish us in the market. Interim results presented at the 2019 annual ASCO meeting from the phase Ib portion of the ongoing phase Ib/II clinical trial of nanatinostat was in combination with the antiviral valganciclovir for the treatment of relapsed/refractory Epstein Barr Virus, or EBV,-associated lymphomas. Three doses of the combination were evaluated with responses seen at all dose levels. Both drugs are taken orally and can be administered in an out-patient setting. EBV-associated cancers are known to be an extremely difficult cancer to treat. Early clinical data with the combination of nanatinostat and anti-viral therapy in EBV-associated lymphoma from the phase Ib/II study has provided encouraging efficacy signals. Currently, there are no approved treatments for EBV-associated lymphomas that specifically target the virus. The combination therapy produced an objective response rate of 58%, a complete response rate of 33% and a disease stabilization rate of 75%. Based on these encouraging results, Viracta anticipates advancement of the clinical trial to the phase II stage that will evaluate intermittent dosing of nanatinostat in combination with daily valganciclovir.
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CBRL | Hot Stocks08:01 EDT Cracker Barrel reports Q3 comparable store restaurant sales up 1.3% - Comparable store restaurant sales growth of 1.3% and traffic of (1.8%) outperformed the casual dining industry.
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ALLO | Hot Stocks07:48 EDT Allogene Therapeutics announces FDA clearance of ALLO-715 IND - Allogene Therapeutics announced that the FDA has cleared Allogene's investigational new drug, or IND, application for ALLO-715 in patients with relapsed/refractory multiple myeloma. The Phase 1 portion of the UNIVERSAL study, which will include ALLO-647 as part of the lymphodepletion regimen, is expected to be initiated in the second half of 2019.
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CELG XLRN | Hot Stocks07:44 EDT Celgene, Acceleron announce FDA acceptance of BLA for luspatercept - Celgene (CELG) and Acceleron Pharma (XLRN) announced that the FDA has accepted Celgene's Biologics License Application, or BLA, for luspatercept, an investigational erythroid maturation agent, for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes, or MDS,-associated anemia who have ring sideroblasts and require red blood cell, or RBC, transfusions, and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions. The FDA has granted Priority Review to this BLA for the evaluation of the beta-thalassemia indication and set a Prescription Drug User Fee Act, or target action, date of December 4. The FDA has also set a PDUFA date of April 4, 2020 for the evaluation of the MDS indication.
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CVS | Hot Stocks07:43 EDT CVS Health sees 2021 adjusted EPS growth in mid single digits - Sees 2022+ adjusted EPS growth in low double digits. Sees operating income of ~$850M in 2022, ~$2.5B long-term. Says on track to deliver savings of ~$900M in 2021 and beyond from integration synergies. Targeting savings of $1.5B-$2B in 2022 and beyond from enterprise modernization. Sees 2020 revenue up low single digits, with tax rate of ~28.5%. Expects to pay down ~$7.5B of debt from close of Aetna transaction to the end of 2019. Says focused on debt reduction in the near-term. Expects $10B-$12B cash available annually for enhancing shareholder value in the long term. Comments taken from Investor Day presentation slides.
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PRIM | Hot Stocks07:43 EDT Primoris announces pipeline awards valued over $23M - Primoris announced two new pipeline awards with a combined value over $23M. The contracts were secured by Primoris Field Services. The awards are for two pump stations in West Texas for an energy customer. The scope of work includes complete civil, mechanical, electrical instrumentation and setting of equipment and final site restoration. Work is scheduled to commence in Q2 and to be completed in Q1 of 2020.
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DRNA | Hot Stocks07:42 EDT Dicerna appoints Rob Ciappenelli Chief Commercial Officer - Dicerna Pharmaceuticals (DRNA) announced the appointment of Rob Ciappenelli as Chief Commercial Officer of Dicerna and member of the company's executive leadership team, effective immediately. Ciappenelli joins Dicerna from Momenta Pharmaceuticals (MNTA), where he was global head of commercial.
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MDWD | Hot Stocks07:41 EDT MediWound receives marketing authorization for NexoBrid in Peru - MediWound announced receipt of authorization from the Ministry of Health in Peru to market and distribute NexoBrid for the removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns. Avalon Pharmaceutical, MediWound's exclusive distribution partner in Peru, received the marketing authorization and intends to launch NexoBrid in Peru in the first half of 2020. This regulatory approval builds upon the European Medicines Agency marketing authorization for the same indication and again validates MediWound's strategy of using the EMA approved registration file for seeking approval in different international markets around the globe.
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PAR BAESY | Hot Stocks07:41 EDT Par Technology subsidiary awarded $15.9M subcontract award - PAR Technology (AR) announced that BAE Systems (BAESY), has awarded PAR subsidiary, Rome Research Corporation, or RRC, a subcontract for the Operation and Maintenance of Multiple Communications Facilities Operating Under Naval Computer and Telecommunications Area Master Station Pacific Program. The contract calls for RRC to provide critical Command, Control, Telecommunications, Computers, and Intelligence, or C4I, and Strategic Communications throughout the Pacific theater and Indian Ocean for the Department of Defense, Missile Defense Agency, Homeland Security and allies throughout the Pacific theater and Indian Ocean. The total value of the subcontract is $15.9M, with a performance period of up to 60 months.
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PCRX | Hot Stocks07:38 EDT Pacira announces publication of Exparel data - Pacira announced the publication of its multinational Phase 3 study supporting the efficacy and safety of Exparel as a single-injection interscalene brachial plexus nerve block, or ISNB, in patients undergoing total shoulder arthroplasty or rotator cuff repair. The results demonstrate that Exparel improved pain control and reduced opioid consumption through 48 hours compared with placebo and a standardized pain management protocol alone. The data, which provided the basis for FDA approval for this indication, were published in Pain Medicine. The study's primary endpoint was pain intensity scores through 48 hours; secondary endpoints included total postsurgical opioid consumption, percentage of opioid-free patients and time to first opioid rescue. A total of 140 patients enrolled across 16 surgical centers in the United States, Belgium and Denmark were randomized to receive an ultrasound-guided single-dose ISNB with either Exparel 133 mg or saline placebo. Compared to patients receiving placebo, patients in the Exparel group demonstrated a statistically significant. Reduction in pain scores measured using the area under the curve of the visual analog scale pain intensity scores through 48 hours. Decrease in total postsurgical opioid consumption, converted to intravenous morphine equivalents, by 78% through 48 hours. Higher percentage of opioid-free patients at both 24 hours and 48 hours. Prolonged time to first use of rescue opioid, with median time to rescue medication of 4.2 hours with Exparel vs 0.6 hours with placebo. Participants in this study were required to remain in the hospital through 72 hours. A standardized pain management protocol was implemented for all patients who were required to remain at the hospital through 72 hours postsurgery. Preoperative analgesics were limited to oral or IV acetaminophen and low-dose aspirin. Intraoperative medication was limited to short-acting opioids. After surgery, patients received up to 1000 mg of oral or IV acetaminophen every eight hours, unless contraindicated. Postsurgical pain rescue medication was limited to oral oxycodone or IV morphine or hydromorphone. Incidence of adverse events, or AEs, was comparable between groups, and most AEs were mild to moderate in severity. No clinically significant between-group differences in laboratory values, vital signs, or electrocardiograms were observed.
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SBBP | Hot Stocks07:34 EDT Strongbridge Biopharma names Scott Wilhoit as chief commercial officer - Strongbridge Biopharma announced the promotion of Scott Wilhoit to chief commercial officer. Scott previously served as senior vice president of global market access, patient services and advocacy. The company also announced the appointment of Marcy Nanus to vice president of corporate affairs, effective June 3. In this newly created role, Marcy will lead the company's investor and media relations, as well as corporate, product and internal communications.
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CAMT | Hot Stocks07:34 EDT Camtek obtains shareholder, CFIUS' approvals for Chroma transaction - Camtek announced that further to the agreements signed on February 11, between the company, Priortech Ltd. and Chroma ATE, as detailed in the company's Report on Form 6-K submitted to the SEC on February 11, and incorporated herein by reference, on June 3, two significant conditions to the closing were fulfilled. The transaction received approval from the Committee on Foreign Investment in the United States, and Camtek's shareholders also approved the transaction. Accordingly, the company estimates that the closing of the transaction is expected to take place by the end of June.
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INCY | Hot Stocks07:33 EDT Incyte treats first patient in FIGHT-302 Phase 3 study of pemigatinib - Incyte announced that the first patient has been treated in FIGHT-302, an open-label Phase 3 study evaluating pemigatinib, its selective fibroblast growth factor receptor, or FGFR, inhibitor, compared to gemcitabine with cisplatin chemotherapy, the current standard of care, as a first-line therapy for patients with metastatic or surgically unresectable cholangiocarcinoma and activating FGFR2 rearrangements.
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CME | Hot Stocks07:32 EDT CME Group reports May ADV up 19% to 23.9M - CME Group reached average daily volume, or ADV, of 23.9M contracts during May up 19% from May 2018. Open interest at the end of May was 143M contracts, up 24% from year-end 2018 and up 14% from May 2018. OI reached a record 143.5M contracts on May 23. Equity Index volume averaged 4.2 million contracts per day in May 2019, up 61% from May 2018.
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LLY | Hot Stocks07:31 EDT Eli Lilly: FDA accepts NDA for triple combination tablet for type 2 diabetes - The U.S. FDA has accepted the New Drug Application for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release for the treatment of adults with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company announced.
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ARVN | Hot Stocks07:30 EDT Arvinas Inc trading resumes
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AVDL | Hot Stocks07:18 EDT Avadel Pharmaceuticals to present new data on sodium oxybate at sleep conference - Avadel Pharmaceuticals announced it will present two posters at the Associated Professional Sleep Societies. The posters highlight pharmacokinetic, or PK, data for its investigational, once-nightly controlled-release sodium oxybate, or FT218, including a head-to-head PK comparison to twice-nightly sodium oxybate and dose proportionality across three doses. The pharmacokinetics and formulation selection pilot study was designed as a four-way crossover study in 16 healthy volunteers, evaluating three proprietary once-nightly formulations of Micropump controlled-release, or CR, sodium oxybate versus twice-nightly immediate-release, or IR, sodium oxybate at a nightly dose of 4.5g. Each subject consumed a standard meal two hours prior to dosing. Subjects receiving the twice-nightly IR sodium oxybate, were administered the second dose 4 hours after the first dose. Two subjects dropped out of the study prior to the completion. FT218 exhibited rapid initial absorption comparable to twice-nightly IR sodium oxybate. FT218 demonstrated a lower overall Cmax than twice-nightly IR sodium oxybate. FT218 mean blood concentrations at 8 hours were similar to that of twice-nightly IR sodium oxybate. Safety and tolerability were similar across administrations The dose proportionality study was an open-label, single-dose, three-sequential-period study in 20 healthy volunteers. Subjects received three separate single-dose administrations of FT218 at bedtime, two hours post-evening meal, in a sequential order of 4.5g, 7.5g and 9g with a minimum 7-day washout between doses. PK profiles were assessed for dose proportionality across the three doses. FT218, at each dose, exhibited PK profiles consistent with those desired for once-nightly dosing. Dose proportionality was maintained for Cmax across the dosage range. Safety profile was consistent with what is known for sodium oxybate The safety and efficacy of FT218 for the once-nightly treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy is currently being evaluated in the Phase 3, multi-centered, double-blind, placebo-controlled REST-ON trial, which is expected to complete enrollment in 2020.
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GPI | Hot Stocks07:16 EDT Group 1 Automotive launches AcceleRide automotive purchase platform - Group 1 Automotive announced the nationwide launch of AcceleRide, the company's new online automotive purchase platform. AcceleRide allows customers to transact a new or used vehicle purchase online. AcceleRide also integrates factory rebate and incentive offers, as well as the opportunity to complete all trade-in details online.
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SRNE | Hot Stocks07:14 EDT Sorrento Therapeutics announce CBD JVs, commercial strategic partnerships - Sorrento Therapeutics announces that it has formed a Chinese joint venture, Shenzhen Yunma Biotechnology, with LifeTech Scientific to commercialize Sorrento's proprietary water soluble cannabidiol, or CBD, formulation technologies for consumer and pharmaceutical applications in Asia, excluding Japan. In addition, Shenzhen Yunma's subsidiary, Yunnan Masheng Health Science, has obtained a Yunnan industrial hemp plantation permit, as well as governmental pre-approval to establish an industrialized processing, CBD extraction and isolation operation in Kunming. Sorrento holds 40% of the equity in the Shenzhen Yunma joint venture and LifeTech holds the remaining 60% of the equity. Sorrento has contributed the exclusive license to Sorrento's water-soluble CBD technology for the Asian territory to Shenzhen Yunma. With the hemp and CBD supplies from Yunnan Masheng secured, Shenzhen Yunma will build manufacturing capacity to potentially deliver hundreds of metric tons of CBD annually to the global markets.Sorrento has also formed a new business unit, Scintilla Health, with LifeTech Scientific International Investment Limited, as a 20% minority holder, to explore commercial opportunities of Sorrento's water-soluble CBD for both consumer and pharmaceutical applications in North America, Europe and other parts of the world. As previously announced Sorrento's CBD formulation concentration could range anywhere from 5% to 10% (50 - 100 mg/ml). This concentration range is believed to be among the highest in the industry, and potentially the highest concentration achieved for a water-soluble formulation.
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BAYRY ARVN | Hot Stocks07:12 EDT Bayer, Arvinas to collaborate on Protac therapies through joint venture - Bayer (BAYRY) and Arvinas (ARVN) announced an agreement to leverage Arvinas' novel Protac protein degrader technology to develop new human therapeutics for patients with cardiovascular, oncological, and gynecological diseases. In addition, Bayer and Arvinas will jointly launch a new company to leverage Arvinas' Protac technology for agricultural applications. The overall series of arrangements includes over $110M in upfront cash and committed funding for the human disease collaboration, the agricultural joint venture and a direct equity investment by Bayer in Arvinas. The multi-faceted deal will extend the application of targeted protein degradation to new therapeutic areas and outside human biology. It leverages Arvinas' knowledge in targeted protein degradation and Bayer's decades of experience in developing both human therapies and agricultural technologies. Bayer and Arvinas will collaborate to seek to develop a series of novel product candidates for diseases with serious unmet need. Arvinas will receive an upfront payment and committed R&D funding, as well as a direct equity investment in Arvinas. Combined, these committed funds exceed $60M. Bayer will own the rights to novel lead structures generated in the collaboration. As programs progress through research, development, and commercialization, Arvinas is also eligible to receive development milestones of over $685M and commercial royalties ranging from the mid-single digits to the low double-digits. In launching a joint venture, or JV, Bayer and Arvinas are investing in feeding the growing global population. Protac targeted protein degraders have the potential to address resistance mechanisms in plants to existing agricultural solutions, with solutions to control weeds, insects and disease by leveraging the selectivity and other features of Protac protein degraders. The JV will be committed to leveraging Arvinas' Protac protein degrader technology to create innovative, safe and sustainable agricultural products. The JV will be supported by intellectual property and over $55M in committed funding from Bayer, and by technology and intellectual property from Arvinas. Bayer and Arvinas will equally share governance and equity ownership of the JV.
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FLOW | Hot Stocks07:06 EDT SPX FLOW appoints Peter Ryan as Vice President, Secretary and General Counsel - SPX FLOW announced that Stephen A. Tsoris, Vice President, Secretary and General Counsel, has decided to retire. Peter J. Ryan will succeed Tsoris as the Vice President, Secretary and General Counsel, effective immediately, and will serve as a corporate officer reporting directly to Marc Michael, President and CEO. Peter and Steve will be working together through the month of July to ensure a smooth transition. Peter J. Ryan began his legal career with Kirkland & Ellis, LLP in Chicago before joining SPX Corporation in 2006. He has served in a variety of corporate and business roles at the Company, with responsibility for claims, compliance, mergers and acquisitions, securities, employment and commercial matters.
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HIL | Hot Stocks07:05 EDT Hill International selected by ITU for construction support services - Hill International announced it has been awarded a contract to provide construction support services for the International Telecommunications Union's new headquarters building in Geneva, Switzerland. Hill will provide external construction project services in support of the ITU's project management team. The project is currently in design with construction scheduled to begin in 2022 with construction estimated to conclude in 2025.
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TTNP | Hot Stocks07:04 EDT Titan Pharmaceuticals executes services agreement with Southside Specialty - Titan Pharmaceuticals announced that it has executed a pharmacy services agreement with Southside Specialty Pharmacy, further expanding access to treatment with Probuphine, or buprenorphine, implant, Titan's novel maintenance treatment for Opioid Use Disorder, or OUD, in eligible patients. Titan expects the majority of Probuphine sales in the U.S. to be through the specialty pharmacy distribution model, where a specialty pharmacy carries inventory, directly handles the subsequent patients' insurance billing and payment processes, and ships to the healthcare provider as prescribed.
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BMIX | Hot Stocks07:04 EDT Brazil Minerals receives last necessary approval for gold, diamond mining - Brazil Minerals announced that it has obtained the last necessary approval from a regulatory entity in Brazil to allow mining for gold and diamonds in one of its many Jequitinhonha River Valley mineral rights. As announced previously, a drilling campaign within this project area indicated that 35 out of 35 drills holes were positive for gold. Additionally, in a majority of such drill holes, satellite markers that indicate the likely presence of diamonds were recovered.
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AIMT | Hot Stocks07:03 EDT Aimmune provides new data from Phase 3 PALISADE follow-on study of AR101 - Aimmune Therapeutics announced results from ARC004, an open-label, rollover study of the landmark Phase 3 PALISADE trial, which showed that extending daily therapy with AR101 by an additional 28 weeks led to improved tolerability with lower numbers of adverse events compared to the PALISADE therapeutic dosing period, an increase in the amount of peanut that could be safely ingested, and continued immunomodulation to peanut protein in most patients. AR101 is an investigational biologic drug for use in oral immunotherapy as a treatment to reduce the frequency and severity of allergic reactions following exposure to peanuts. These data were presented here today in an oral session at the European Academy of Allergy and Clinical Immunology Congress 2019 in Lisbon. After continuing daily doses of AR101 for an additional 28 weeks, the majority of patients enrolled in the follow-on study could tolerate doses of at least 1,000 mg of peanut protein, and nearly half of all AR101-treated patients tolerated the highest 2,000 mg dose during the exit food challenge. Furthermore, patients enrolled in the study continued to see meaningful immunological changes, reinforcing the potential benefits of continued daily AR101 dosing after one year.
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BAYRY ARVN | Hot Stocks07:03 EDT Bayer, Arvinas to develop proteolysis-targeting chimera candidates - Bayer (BAYRY) announced a collaboration with Arvinas (ARVN). The new life science research partnership uniquely leverages the full potential of Arvinas' novel PROTAC technology, coupled with leading expertise of Bayer in health and agriculture to develop innovations for the benefit of patients and farmers. Bayer will form an exclusive joint venture as the first company to explore the PROTAC technology in agriculture for crop protection, and at the same time, establish a target-based pharmaceutical research collaboration with Arvinas. In addition, Bayer will make an equity investment to sustain its commitment for the technology. Under the terms of the agreement, Arvinas will receive an upfront payment and pharmaceutical R&D support over the next four years, as well as a direct equity investment. These investments, combined, will exceed $60M. Bayer will own the rights to novel lead structures generated in the course of the collaboration. As programs progress through research, development, and commercialization, Arvinas is eligible to receive pre-defined development milestones of over $685M and commercial royalties.
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PTI | Hot Stocks07:02 EDT Proteostasis receives orphan drug designation for PTI-428 in Europe - Proteostasis Therapeutics announced that the European Commission has granted orphan drug designation, or ODD, to PTI-428 for the treatment of cystic fibrosis. PTI-428 is the Company's proprietary cystic fibrosis transmembrane conductance regulator, or CFTR, amplifier that is currently in clinical development. In addition to ODD from the EC, PTI-428 has ODD, Breakthrough Therapy Designation and Fast Track Designation from the FDA. ODD in the European Union is based upon a positive opinion from the European Medicines Agency's Committee for Orphan Medicinal Products and provides regulatory and financial incentives for companies to develop and market therapies to treat serious disorders affecting no more than five in 10,000 persons in the EU.
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RARX | Hot Stocks07:01 EDT RA Pharmaceuticals announces FDA clearance of zilucoplan IND application - Ra Pharmaceuticals announced the FDA clearance of the company's Investigational New Drug, or IND, application for zilucoplan for the treatment of immune-mediated necrotizing myopathy. The company is on track to initiate a Phase 2 clinical trial in the second half of 2019.
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RARX | Hot Stocks07:01 EDT RA Pharmaceuticals announces FDA clearance of zilucoplan IND application - Ra Pharmaceuticals announced the FDA clearance of the company's Investigational New Drug, or IND, application for zilucoplan for the treatment of immune-mediated necrotizing myopathy (IMNM). The company is on track to initiate a Phase 2 clinical trial in the second half of 2019.
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CVS | Hot Stocks07:00 EDT CVS Health plans to have 1,500 new HealthHUBs by end of 2021 - The CVS Health management team is focused on: "Growing and differentiating CVS Health's businesses with a focus on driving engagement through personalization, winning in high-growth products and services and delivering new and innovative benefit designs and reimbursement models. Expanding HealthHUBs to build on the success of its pilot program in Houston, TX. HealthHUBs are a powerful example of how CVS Health can provide consumers with convenient, personalized and integrated access to local health care. The company will open additional HealthHUBs in Houston, Atlanta, Philadelphia/Southern New Jersey and Tampa this year, and plans to have 1,500 total HealthHUBs operating by the end of 2021. Taking advantage of the unmatched breadth of CVS Health's capabilities to introduce new products and services. CVS Health will optimize government programs, introduce new risk-based carve-outs, develop programs aimed at complex conditions like chronic kidney disease, and create new analytics products. Building a robust technology infrastructure designed to support transformational initiatives and protect CVS Health's breadth of data. CVS Health will deploy that data across the organization to create a holistic view of the patient, which will offer insights on how to communicate with the patient most effectively, including providing the next best action they can take to improve their health. Realizing cost savings by modernizing enterprise functions and efficiently integrating operations following the Aetna transaction."
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ARVN | Hot Stocks06:55 EDT Arvinas Inc trading halted, news pending
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TIF | Hot Stocks06:51 EDT Tiffany down 5.7% to $85.00 after lowering FY19 profit outlook
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IGT | Hot Stocks06:47 EDT IGT to provide PlayRGS solution, Play Casino content to Veikkaus Oy in Finland - International Game Technology announced that its subsidiary IGT Global Services has signed an agreement with Finnish lottery operator Veikkaus Oy to deliver IGT PlayDigital's PlayRGS solution and PlayCasino content. The agreement, which is for an initial term of four years with a provision for possible one-year renewal periods after the initial period, includes PlayRGS installation, maintenance, monitoring, support, as well as access to the complete library of IGT PlayCasino content and marketing support.
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TIF | Hot Stocks06:47 EDT Tiffany reports Q1 gross margin 61.7% vs. 63% a year ago - The lower margin largely reflected sales deleverage on fixed costs, changes in sales mix toward higher price point jewelry, and an increase in wholesale sales of diamonds, partly offset by lower product related costs. Net inventories at April 30 were 6% above the prior year due to a higher level of finished goods inventories, reflecting recent sales performance and strategic investments in High Jewelry.
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TIF | Hot Stocks06:45 EDT Tiffany CEO says Q1 results 'reflect significant foreign exchange headwinds' - Alessandro Bogliolo, CEO, said, "Our first quarter results reflect significant foreign exchange headwinds and dramatically lower worldwide spending attributed to foreign tourists. That said, we were pleased that, at the core of our business, global sales attributed to local customers, led by sales in China, grew over last year's very strong sales results. We believe this growth in sales to local customers reflects progress in executing our strategic priorities, including innovations across products, communications and the customer experience, and that Tiffany is positioned for improving trends in the second half of 2019."
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TIF | Hot Stocks06:41 EDT Tiffany raises quarterly dividend 5% to 58c from 55c per share - The dividend will be paid on July 10 to shareholders of record on June 20.
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TIF | Hot Stocks06:40 EDT Tiffany reports Q1 SSS ex-FX down 2%
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NAV | Hot Stocks06:34 EDT Navistar reports one-time charge of $159M in Q2 - The net loss of $48M in the quarter reflected a one-time charge of $159M to address a legal class action settlement and related litigation from legacy engines.
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NOVN | Hot Stocks06:33 EDT Novan: First patient enrolled in SB206 Phase 3 molluscum program - Novan announced that the first patient has been dosed in the company's "B-SIMPLE" Phase 3 program. The study is designed to evaluate topical nitric oxide product candidate SB206 for the treatment of molluscum contagiosum. The B-SIMPLE Phase 3 program consists of two multi-center, randomized, double-blind, vehicle-controlled studies, B-SIMPLE1 and B-SIMPLE2. Each study will enroll approximately 340 patients. The program will evaluate the efficacy and safety of SB206 12% QD (once daily) compared to vehicle (placebo) for the treatment of molluscum. Novan is targeting top line efficacy and safety results no later than early in the first quarter of 2020.
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UBER | Hot Stocks06:33 EDT Uber says Q1 gross unrecognized tax benefits increased by $1.3B - In a regulatory filing, Uber said that during the three months ended March 31, 2019, the amount of gross unrecognized tax benefits increased by $1.3B, of which substantially all, if recognized, would not affect the annual effective tax rate as these unrecognized tax benefits would increase deferred tax assets that would be subject to a full valuation allowance. The company recorded an income tax expense of $576M and $19M for the three months ended March 31, 2018 and 2019, with an effective tax rate of 13% and (2)%, respectively. During the three months ended March 31, 2018, income tax expense was primarily driven by deferred U.S. tax expense related to the company's investment in Didi and Grab, deferred China tax related to the company's investment in Didi, and to a lesser extent, the benefit of U.S. losses and current tax on foreign earnings. During the three months ended March 31, 2019, income tax expense is primarily driven by current tax on foreign earnings, partially offset by the benefit of U.S. losses. The primary differences between the effective tax rate and the federal statutory tax rate are due to the valuation allowance on the company's U.S. and Netherlands' deferred tax assets and foreign tax rate differences.
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MGLN | Hot Stocks06:32 EDT Magellan Health division launches medical pharmacy solution - Magellan Rx Management, the pharmacy benefit management division of Magellan Health, announced the launch of a medical pharmacy solution targeting oncology therapeutic biosimilars. In preparation for the expected 2019 market entry of oncology biosimilars, the solution aims to educate customers, members and providers through the implementation of individualized strategies that consider clinical, financial and regulatory factors. This will ultimately result in maintaining or expanding member access to clinically-effective treatments, while having the added benefit of delivering significant drug spend savings for participating customers.
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LYB | Hot Stocks06:32 EDT LyondellBasell, Odebrecht end talks regarding Braskem acquisition - LyondellBasell announced it has ended discussions with Odebrecht S.A. concerning the potential acquisition of Braskem. Odebrecht S.A. is the controlling shareholder of Sao Paulo-based Braskem. "The combination of LyondellBasell and Braskem is compelling because of the companies' complementary strengths, product portfolios and operational footprints. However, after careful consideration, we jointly decided not to pursue the transaction. We want to thank the teams at Odebrecht and Braskem for their cooperation during the entire process," said LyondellBasell CEO Bob Patel. "We remain focused on advancing our disciplined, value-driven growth strategy. In addition, we intend to expedite our share repurchase program, which currently allows for the repurchase of up to 37 million of our outstanding shares. Our strong cash flows, ample liquidity, and healthy balance sheet allow us to deliver a growing, top-quartile dividend, advance organic growth, and maintain optionality for M&A opportunities while executing these significant opportunistic share repurchases," said Patel.
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ARR | Hot Stocks06:32 EDT Armour Residential raises share repurchase program to 9M shares - Armour Residential announced that its board of directors has authorized an increase to its existing stock repurchase program of up to an aggregate of 9M shares of the company's outstanding common stock, par value $0.001 per share. The company's previous 9M repurchase authorization was established in July 2015. Under that authorization, the company has repurchased approximately 7,376,000 shares of common stock, including open market purchases of 250,000 shares since May 30.
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UBER | Hot Stocks06:32 EDT Uber says under federal income tax examination by IRS for 2013, 2014 - In a regulatory filing, Uber said it is currently under a federal income tax examination by the Internal Revenue Service for tax years 2013 and 2014. The company is also under examination by various state and foreign tax authorities, it said. The company believes that adequate amounts have been reserved in these jurisdictions. To the extent the company has tax attribute carryforwards, the tax years in which the attribute was generated may still be adjusted upon examination by federal, state or foreign tax authorities to the extent utilized in a future period. For the company's major tax jurisdictions, the tax years 2010 through 2019 remain open; the major tax jurisdictions are U.S., Brazil, Netherlands, Mexico, United Kingdom, Australia, Singapore, and India. Although the timing of the resolution and/or closure of audits is highly uncertain, it is reasonably possible that the balance of gross unrecognized tax benefits could significantly change in the next 12 months. Given the number of years remaining subject to examination and the number of matters being examined, the company is unable to estimate the full range of possible adjustments to the balance of gross unrecognized tax benefits. The company does expect the gross amount of unrecognized tax benefits to be reduced within the next twelve months by at least $141M which is related to ongoing matters with tax authorities regarding the company's transfer pricing positions.
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WMT | Hot Stocks06:10 EDT Walmart expands education program for workers - Walmart said in a statement that it is is committed to winning the future of retail and knows investing in its people is essential to serving customers today and in the future. To help prepare its workforce for tomorrow, the retailer is expanding its Live Better U education benefit to include new technology degrees and certificates for $1 a day and offering high school students a bridge into the workforce, including access to all its learning programs. These enhancements come a year after Walmart announced the education benefit, which is designed to help remove barriers - like cost, time and earning a relevant degree "Walmart values learning in all forms, and we are committed to creating a workforce of lifelong learners and instilling in them excitement for retail and a passion for serving customers. Access to higher education is one way to grow your career. So, in addition to providing people with an entry to the workforce and access to our on-the-job training I'm proud Walmart also offers our associates programs like Live Better U to help them achieve their educational goals," said Greg Foran, president and CEO of Walmart U.S. Reference Link
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NEW | Hot Stocks06:05 EDT Puxin Limited CEO Yunlong Sha resigns from audit committee - Puxin Limited announced the appointment of Neng Wang, an independent director on the company's board of directors, as a member of the audit committee of the board, effective June 4. Wang replaces Yunlong Sha, founder, chairman and CEO of Puxin, who has served as a member of the audit committee since June 2018. Sha resigned as a member of the audit committee of the board concurrently with Wang's appointment. Sha will remain a member of the compensation committee and chair of the nominating and corporate governance committee of the board.
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NHI | Hot Stocks06:02 EDT National Health Investors enters into joint venture with affiliates of Discovery - National Health Investors announced that it has entered into a property-company joint venture with affiliates of its current tenant, Discovery Senior Living. Six properties, located in Pennsylvania, Maryland and Indiana, will be purchased by the joint venture for $128.35M, including up to $1.5M in estimated closing costs and expenses. The properties consist of 145 independent units, 356 assisted living units and 95 memory care units and will be leased to affiliates of Discovery in a 10-year lease with a 6.5% initial annual cash yield with a CPI-based escalator with a 2% floor and 3% cap beginning in year two. There are two five-year extension options. NHI, the managing member, will own 97.5% of the joint venture equity and Discovery will own 2.5%. NHI has committed to a senior mortgage loan of $6M at 7% annual interest extended to affiliates of Discovery for an additional property in Indiana for which the joint venture will have the option to purchase at stabilization. The facility consists of 52 assisted living units and 22 memory care units. The loan is scheduled to be closed by June 30.
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AMZN | Hot Stocks05:58 EDT Amazon says 10M items now qualify for 1-day delivery - In a blog post, Amazon said: "As you may have heard, we are expanding one-day delivery with Amazon Prime. Today, Prime Free One Day is available to members with no minimum purchase amount on more than ten million products, coast to coast. Millions of members are already noticing and enjoying free one-day delivery right to their door, garage and even to their car. That means last-minute birthday presents, sunscreen and beach towels for an impromptu getaway, as well as closet organizers and cleaning products - all delivered the very next day... We obsess over making customers' lives easier, better and more fun with Prime. In fact, Amazon customers in thousands of cities and towns across 44 major metropolitan areas already have access to millions of items with free same-day delivery. Simply look for items marked as eligible for delivery today, order before lunch, and get them by bed time. For delivery in a matter of hours, members can also use Prime Now to receive grocery delivery from Whole Foods Market in nearly 90 U.S. metros, or grocery pickup in as little as 30 minutes in 30 metros, with more to come in 2019. We have also introduced multiple package pickup and return options to make delivery even more convenient, including Amazon Locker and Amazon pickup locations in towns and cities across the U.S., as well as in-garage, in-car and in-home deliveries with Key for Amazon." Reference Link
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KOS | Hot Stocks05:14 EDT Kosmos announces an oil discovery at Gladden Deep - Kosmos Energy announced an oil discovery at Gladden Deep, which Kosmos has a 20% working interest. "Gladden Deep is a sub-sea tie back which is expected to be brought online through the existing Gladden pipeline to the Medusa spar in the fourth quarter of 2019." Based on preliminary analysis of drilling and wireline logging results the recoverable resource is expected to be in line with the pre drill estimate of 7 mmboe gross.
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OBSV | Hot Stocks05:10 EDT ObsEva completes patient recruitment in IMPLANT 4 Phase 3 clinical trial - ObsEva reported completion of patient recruitment of IMPLANT 4 Phase 3 clinical trial of its oral oxytocin receptor antagonist, nolasiban, for the improvement of rates of pregnancy and live birth in patients undergoing embryo transfer following assisted reproduction technology, or in-vitro fertilization.
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RHHBY | Hot Stocks05:09 EDT Genentech says Phase III BLOCKSTONE study met primary endpoint - Genentech, a member of the Roche Group, announced that the Phase III BLOCKSTONE study, conducted by Shionogi, met its primary endpoint showing that people exposed to a household member with influenza and treated preventatively with XOFLUZA were significantly less likely to develop the disease compared to those treated with placebo. Furthermore, XOFLUZA was well tolerated with no safety signals identified. Full results from the BLOCKSTONE study will be presented at an upcoming medical meeting. XOFLUZA is currently approved in Japan for the treatment of influenza types A and B in children, adolescents and adults, and in the U.S. for the treatment of acute, uncomplicated influenza in people 12 years of age and older. In addition, the FDA recently accepted a supplemental New Drug Application for XOFLUZA as a one-dose oral treatment for people at high risk of complications from the flu, which includes adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, morbid obesity or heart disease - for these people the flu can be particularly serious or deadly. The FDA is expected to decide on whether to approve this additional indication by November 4.
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