Stockwinners Market Radar for June 20, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
KFY... | Hot Stocks19:05 EDT Fly Intel: After Hours Movers - DOWN AFTER EARNINGS: Korn/Ferry (KFY) down 6.7%. ALSO LOWER: Exelixis (EXEL) down 7.3% after its IMspire170 phase 3 study did not meet primary endpoint... Sealed Air (SEE) down 7.3% after disclosing SEC investigation and terminating its CFO for cause... PayPal (PYPL) down 1.8% after resignation of its COO. Movers as of 18:45ET.
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EXEL RHHBY | Hot Stocks19:01 EDT Exelixis informed by Genentech that IMspire170 did not meet primary endpoint - In a regulatory 8-k filing, Exelixis (EXEL) disclosed it was informed by its collaboration partner Genentech, a member of the Roche Group (RHHBY), that IMspire170, the phase 3 trial evaluating the combination of cobimetinib, an Exelixis-discovered MEK inhibitor, and atezolizumab, an anti-PDL1 antibody discovered and developed by Genentech, did not meet its primary endpoint of progression-free survival compared to pembrolizumab, a current standard of care, in patients with previously untreated BRAF V600 wild-type advanced melanoma. IMspire170 showed the combination of cobimetinib and atezolizumab did not reduce the risk of disease progression or death compared to pembrolizumab. The safety profile observed in the trial was consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Genentech, the sponsor of IMspire170, informed Exelixis that Genentech intends to present results from the trial at an upcoming medical meeting.
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MDB | Hot Stocks18:44 EDT MongoDB CEO: Every company is becoming a software company - In an interview on CNBC's Mad Money, MongoDB (MDB) CEO Dev Ittycheria said: We are a modern database... We make it really easy to work with data... Our architecture is built for the modern, Cloud computing world... We respect Oracle (ORCL), but their technology is too old... Our customers are very demanding... We feel very good about our value proposition based on our wide variety of customers... Developers love us because we are designed for the Cloud.
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VRML | Hot Stocks18:37 EDT Vermillion adds two contracted agreements for OVA1 cancer risk test - Vermillion has further expanded preferred coverage of its OVA1 - Multivariate Index Assay, MIA - ovarian cancer risk assessment test with the addition of two new health plan in network contracts, Blue Cross Blue Shield of Texas and Blue Cross Blue Shield of Arizona, providing contract coverage to nearly 6 million additional lives.
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CAT | Hot Stocks18:34 EDT Caterpillar CEO: We take a long-term view - In an interview on CNBC's Mad Money, Caterpillar CEO Jim Umpleby said: We are a much stronger company today due to our new strategy... Managing trade tensions is not new to us... We are comfortable meeting our targets in the face of the tariffs... We are going to be more consistent with share repurchases... We plan to have a healthy balance sheet for any M&A... We have been investing heavily in our digital capabilities... We are targeting a million connected assets by the end of the year... We are laser focused at getting returns on our investments... We're a big part of the Permian story... North America is still strong for us.
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CSGP | Hot Stocks18:11 EDT CoStar Group acquires Off Campus Partners - CoStar Group has acquired Off Campus Partners, an online multifamily marketplace service for student housing in the U.S. Founded in Charlottesville, Virginia in 2000 by a University of Virginia student, OCP enters into exclusive agreements with universities, most of which are multi-year, to provide an off-campus housing listing service for students, parents, and faculty/staff. Currently, it has existing contracts with 132 universities servicing over 2 million off-campus students.
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BDX | Hot Stocks17:55 EDT Becton Dickinson backs safety of its Lutonix drug-coated balloons in SFA - BD issued the following statement following the U.S. Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting related to the potential increase in mortality associated with the use of paclitaxel-coated devices in patients with peripheral arterial disease in the superficial femoropopliteal artery:The panel discussed the benefits of paclitaxel-coated devices relative to the potential risks and noted strong evidence of benefit and recommended additional efforts to evaluate long-term safety. Additionally, BD presented its own data confirming that the benefits outweigh the risks for LUTONIX Drug-Coated Balloons in SFA. Over the past several months, BD has been working diligently to obtain all available patient follow up data and collaborating with FDA, professional clinical organizations and industry to investigate the important issue of DCB safety. BD continues to stand behind the safety of its LUTONIX DCBs and is committed to improving the quality of life for patients with PAD. BD will continue to collaborate with FDA, industry and professional organizations to collect and analyze data for the benefit of patients. To ensure patients with PAD continue to receive the best care possible, BD will continue to ensure physicians and patients have access to BD's broad range of treatment options for this serious disease.
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CPF | Hot Stocks17:41 EDT Central Pacific authorizes buyback of up to $30M in common stock - Central Pacific announced that its board has authorized the repurchase of up to $30M of its outstanding common stock under its share repurchase program. This authorization will supersede the remaining repurchase authority under the prior repurchase program.
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AEL | Hot Stocks17:33 EDT American Equity director Debra Richardson sells almost $2.2M in company shares - American Equity director Debra Richardson disclosed in a filing that she had sold 80,000 shares of company stock at $27.40 per share on June 18. The total transaction value of the sale was $2,192,144.
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SEE | Hot Stocks17:27 EDT Sealed Air names James Sullivan as new CFO, effective June 24 - Sealed Air announced it has appointed James Sullivan as CFO, effective June 24. Sullivan most recently served as the Executive Vice President and CFO of Joy Global, a manufacturer and servicer of high productivity mining equipment, from 2012 to 2017.
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AJRD | Hot Stocks17:27 EDT Aerojet Rocketdyne subsidiary awarded $140.18M missile defense modification - Coleman Aerospace, a wholly owned subsidiary of Aerojet Rocketdyne is being awarded a $140.18M firm-fixed-price modification to a previously awarded contract. The value of this contract is being increased from $366.38M by $140.18M to $506.56M by exercising this option. Under this modification, the contractor will provide six additional medium range ballistic missile targets and associated nonrecurring engineering. The work will be performed in Orlando, Florida. The performance period is from June through December 2027. FY19 research, development, test and evaluation funds in the amount of $22.47M are being obligated on this award. One offeror was solicited and one offer was received. The Missile Defense Agency is the contracting activity.
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SEE | Hot Stocks17:25 EDT Sealed Air terminates CFO William Stiehl for cause, effective immediately - Sealed Air announced that its Board of Directors has terminated the employment of William Stiehl as CFO for cause, effective immediately. Stiehl's termination is related to an internal review by the Audit Committee of the Board of Directors in connection with the previously disclosed investigation by the U.S. SEC. This review followed the company's receipt of an additional subpoena for documents and information on May 2, relating to the process by which the company selected its independent audit firm for the period beginning with fiscal year 2015, and relating to the independence of that audit firm. The company is continuing to cooperate with the SEC's investigation.
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LKSD | Hot Stocks17:11 EDT LSC comments on DOJ action regarding proposed transaction with Quad - LSC Communications announced that the U.S. Department of Justice filed a lawsuit in the United States District Court for the Northern District of Illinois to enjoin Quad's proposed acquisition of LSC Communications. The companies believe that the DOJ has reached the wrong conclusion in its assessment of the transaction and LSC will join Quad in vigorously defending the lawsuit in court. Contrary to the DOJ's position, the benefits and synergies to be realized from the proposed acquisition are pro-competitive and will benefit the companies' clients for the following reasons: There is significant excess capacity in the printing industry today and this transaction would improve efficiencies and lower printing costs; Many printers have the capability to print the same jobs as LSC Communications or Quad and successfully compete with both companies on quality and price; Barriers to expansion and entry in the printing business are low and printers can easily expand their production capacity through acquisitions or with modest capital expenditures on equipment and facilities that are readily available; and The trend toward digital substitution increases competition and disincentives price increases. "We believe that the DOJ is wrong in its assessment of our transaction and that its action is counterproductive, especially in the context of the industry trends and continued consolidation. We continue to believe that our proposed combination will provide an overall more efficient experience for our clients," said Thomas J. Quinlan III, LSC Communications Chairman, Chief Executive Officer and President. "As we move forward, we will continue to be focused on serving our clients' needs with the same level of service, innovation, and industry leading solutions that they have come to expect. We remain fully committed to this transaction and believe that this is the best path forward for our company and all of our stakeholders."The all-stock transaction was announced on October 31, 2018, and was approved by shareholders of both companies on February 22. At this time, the companies are unable to predict the timeframe for completion of the litigation or closing of the transaction.
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QUAD LKSD | Hot Stocks17:10 EDT Quad/Graphics intends to defend proposed LSC Communications acquisition - Quad/Graphics (QUAD) announced that it intends to defend its proposed acquisition of LSC Communications (LKSD) in response to the U.S. Department of Justice's, or DOJ, lawsuit seeking to block the acquisition. The all-stock transaction was announced on October 31, 2018, and was approved by shareholders of both companies on February 22. Quad intends to work together with LSC to contest the DOJ's allegations. "We believe the acquisition of LSC will result in time- and cost-saving opportunities for clients while protecting jobs for employees. We also believe that the business combination will create a highly efficient print manufacturing and distribution platform that will strengthen the role of print in an increasingly multichannel media world that is dominated by digital advertising," said Joel Quadracci, Quad chairman, president & CEO. "We are fully committed to defending the DOJ's lawsuit in court. We believe the combination of Quad and LSC is the best outcome for all stakeholders and that the DOJ's attempt to stop the transaction will unfavorably impact our clients, our employees, and the print industry. The DOJ's position ignores the dynamic conditions in the U.S. commercial printing industry, which consists of nearly 50,000 companies, generates an estimated $76 billion in aggregate annual revenues and provides ample competition for the supply of printed products, especially in the face of decreasing demand. Neither Quad nor LSC accounts for more than 5 percent of that total print industry revenue. By comparison, two digital media companies, Google and Facebook alone, have worldwide digital ad sale revenues totaling more than $75 billion - nearly the same amount as the entire printing industry. This underscores a key point: Our competition is not only other printers, but also other forms of media. Quad is in the business of manufacturing advertising and, therefore, is a direct competitor to digital channels. Given the continued migration of advertising dollars to digital channels, the printing industry has pursued platform consolidations as a key way to eliminate inefficient and expensive overcapacity, streamline operations and create the efficiencies. This will help ensure print remains an economically feasible alternative to digital channels for publishers and retailers. Our goal is to make print a more effective and affordable media option to that of digital giants such as Google and Facebook. The DOJ does not appear to recognize the competitive effect of digital media on the print industry." Either Quad or LSC can terminate the merger agreement if the transaction is not consummated by October 30 or if there is a final, non-appealable order preventing the transaction. In this case, Quad will be required to pay LSC a "regulatory approval reverse termination fee" of $45M.
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SFM | Hot Stocks17:04 EDT Sprouts Farmers Market interim co-CEO/CFO Brad Lukow resigns - Sprouts Farmers Market announced that Jack Sinclair has been appointed as the company's CEO and a member of its board of directors, effective June 24, 2019. Sinclair has been CEO of 99 Cents Only Stores LLC since 2018 and prior to that was its chief merchandising officer from 2015 to 2018. Sprouts also announced that Brad Lukow, interim co-CEO and CFO, has resigned to pursue other opportunities. The board has appointed Lawrence "Chip" Molloy to serve as interim CFO until a permanent successor has been named.
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HPQ | Hot Stocks16:57 EDT HP Inc. General Counsel sells 20K shares of common stock - In a regulatory filing, HP Inc disclosed that its General Counsel Kim Rivera sold 20K shares of common stock on June 19th. The total transaction size was $410.6K.
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CPT | Hot Stocks16:54 EDT Camden Property COO sells 16.2K shares of common stock - In a regulatory filing, Camden Property disclosed that its COO Malcolm Stewart sold 16.2K shares of common stock on June 18th. The total transaction size was $1.74M.
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COMM | Hot Stocks16:52 EDT CommScope's distributed antenna system patents upheld in favorable ruling - CommScope received notification that it won a jury verdict upholding CommScope's patents relating to digital distributed antenna systems. The Northern District of Texas jury found that Dali Wireless willfully infringed each of the five asserted CommScope patents, finding that both Dali's t-Series and Matrix products infringe each of CommScope's five patents. CommScope expects the court will enter an injunction barring Dali from selling the t-Series and Matrix products in the U.S. Further, due to the jury's finding that Dali willfully infringed each of CommScope's five patents, CommScope will request treble damages and an award of its fees associated with bringing the action. The jury also found that CommScope infringed two Dali patents. One of the patents related to a CommScope product that is discontinued and the other patent is currently in Inter Partes Review. The Patent Trial and Appeal Board has already indicated in a preliminary ruling that the claims are likely to be found invalid. None of the infringement was found to be willful and CommScope believes that there are outstanding legal issues that will bar Dali from any recovery of damages in this case. A final decision from the PTAB is expected in August.
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EGY | Hot Stocks16:46 EDT VAALCO Energy announces $10M stock buyback program - VAALCO Energy announced that its board has authorized a stock repurchase program under which the company can repurchase up to $10M of the currently outstanding shares of common stock, over a period of 12 months.
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HSIC | Hot Stocks16:35 EDT Henry Schein CFO Steven Paladino sells almost $1.5M in company shares - Henry Schein CFO Steven Paladino disclosed in a filing that he had sold 20,712 shares of company stock at $72.17 per share on June 19. The total transaction value of the sale was $1,494,785.
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CTRV | Hot Stocks16:34 EDT ContraVir Pharma receives positive FDA response to NASH candidate plans - ContraVir Pharmaceuticals received "positive" feedback from the FDA in response to ContraVir's pre-Investigational New Drug meeting with respect to the development of CRV431 in NASH. The FDA provided positive feedback on ContraVir's existing preclinical data of CRV431 and supports the study design for the NASH IND opening study. The FDA also concurred with the company's proposed plan for further preclinical studies to support the development of CRV431. Overall, the FDA supported ContraVir's clinical development plans for CRV431 in the NASH indication.
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MTX | Hot Stocks16:31 EDT Minerals Technologies initiates restructuring program through staff cuts - Minerals Technologies has adjusted its outlook due to "several factors." First, shipments out of the company's facilities in the Western United States have been temporarily impacted by flooding-related rail infrastructure issues since early June that have required the logistics provider to cease all railroad traffic. MTI has communicated with its affected customers and is working diligently to minimize supply chain disruptions, which are expected to last at least 30 days. In addition, the company is also experiencing slowing demand in the U.S. Metalcasting market, as well as generally weaker demand in China and Europe. The company has initiated a cost savings program, primarily through workforce reductions, to address the demand environment and improve profitability. The pre-tax annualized savings from the program will be approximately $12M, beginning in Q3 and achieving full run-rate in the first half of 2020. A pre-tax charge of approximately $12M will be recorded in the second quarter of 2019. CEO Douglas T. Dietrich states: "Rail traffic limitations caused by severe flooding have temporarily affected our U.S. Bentonite shipments. Furthermore, the strong demand we saw in March and April changed rapidly in May and further in June, primarily in U.S. automotive, heavy truck and agricultural equipment, leading to lower volumes in our U.S. Metalcasting business. We are also experiencing weaker demand across our China and European markets. These factors have contributed to our reduced outlook for the second quarter."
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YUMA | Hot Stocks16:26 EDT Yuma Energy discloses noncompliance notice from NYSE - Yuma Energy announced that on June 17, 2019, Yuma was notified by the NYSE American LLC that the company is not in compliance with one of the exchange's continued listing standards. Specifically, Yuma is not in compliance with Section 1003(a)(iii) of the Company Guide in that it has reported a stockholders' equity of less than $6M as of March 31, 2019 and reported losses from continuing operations and/or net losses in its five most recent fiscal years. In order to maintain its listing on the Exchange, the company was requested to submit a plan of compliance by July 17, 2019 addressing how it intends to regain compliance by December 17, 2020. Yuma intends to fully comply with the Exchange's requests and will submit its plan accordingly.
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RHT | Hot Stocks16:23 EDT Red Hat reports Q1 subscription revenue $815M, up 15% from last year - CFO Eric Shander states: "Our large deal momentum remained strong, as we doubled the number of deals over $5M and saw 15% growth in the number of deals over $1M from the year-ago quarter. Many of these deals contained emerging technologies, including an OpenStack deal for over $5M and our largest ever storage and hyperconverged deal for over $15M. The breadth of our success demonstrates that customers can realize significant value across our product portfolio."
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OFC BX | Hot Stocks16:22 EDT Corporate Office Properties forms JV with Blackstone subsidiary for acquisition - Corporate Office Properties (OFC), or COPT, announced the formation of a joint venture, or JV, with Blackstone (BX) subsidiary Blackstone Real Estate Income Trust, or BREIT, to acquire seven of COPT's existing, single-tenant, data center shell properties, which contain 1.2M square feet of warehouse space, for a total value of approximately $265M. COPT received $238.5M in proceeds from this transaction. The joint venture will be owned 90% by BREIT and 10% by COPT.
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THC | Hot Stocks16:19 EDT Tenet Vice Chairman Keith Pitts to retire on August 31st - Tenet Healthcare Corp announced that Keith Pitts, Vice Chairman, will retire from his position on August 31, 2019.
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LNTH | Hot Stocks16:18 EDT Lantheus to present new patient outcomes data at ASE 2019 - Lantheus announced that new clinical outcomes data for DEFINITY Vial for Injectable Suspension in intensive care unit patients will be presented at the American Society of Echocardiography, or ASE 2019, Annual Scientific Sessions, being held June 21-25, 2019, at the Oregon Convention Center in Portland, Oregon. Lantheus will also host a scientific symposium and interactive panel discussion focused on enhanced echocardiography. DEFINITY is a cardiovascular ultrasound contrast agent currently indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
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MPC | Hot Stocks16:17 EDT Marathon Petroleum names Donald Templin as EVP and CFO, effective July 1 - Marathon Petroleum announced that Donald Templin, currently MPC's president of Refining, Marketing and Supply, has been appointed executive vice president and CFO, effective July 1. Templin replaces Timothy Griffith as CFO, after Griffith was appointed president of MPC subsidiary Speedway. Templin joined the company as senior vice president and CFO in 2011, and also became CFO of MPLX GP LLC in 2012. Since 2015, he has led segments of MPC's commercial business, most recently serving as president of Refining, Marketing and Supply since 2018, and as President of MPLX GP LLC from 2016 to 2017.
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PCSB | Hot Stocks16:16 EDT PCSB Financial authorizes repurchase of up to 890K shares of common stock - PCSB Financial announced that it has authorized a program to repurchase up to 890,021 shares, representing 5% of its outstanding shares of common stock. The timing and amount of any repurchases will depend on various factors, including but not limited to, market conditions, stock price, and alternative uses of capital.
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KFY | Hot Stocks16:13 EDT Korn/Ferry down 6% to $45.60 after Q4 results, Q1 guidance
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PYPL | Hot Stocks16:13 EDT PayPal announces planned departure of COO Bill Ready - PayPal announced that its COO Bill Ready will transition at the end of 2019 to pursue entrepreneurial interests outside the company.
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SOLO | Hot Stocks16:11 EDT Electra Meccanica appoints Jerry Kroll CEO - Electra Meccanica Vehicles Corp. announced the appointment of automotive and advanced propulsion systems expert, Paul Rivera, as the company's new CEO. Jerry Kroll, who is founder and has served as CEO since 2015, will continue to advise in the future as a board member. Rivera most recently served as President of Ricardo, USA, a division of Ricardo, PLC.
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LPLA | Hot Stocks16:10 EDT LPL Financial reports total client cash balances at the end of May $29.8B - LPL Financial released its monthly activity report for May. Total brokerage and advisory assets served at the end of May were approximately $677B, a $22B decrease, or 3.1% compared to the end of April 2019. Total net new assets for May were an inflow of $1.4B. This included $0.4B of outflows related to a large hybrid firm that is setting up its own broker/dealer and departing as discussed during the company's Q1 2019 earnings call. Prior to these outflows, total net new assets for May were an inflow of $1.8B.
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ALSK | Hot Stocks16:10 EDT Alaska Communications board directs company to buy 1M shares under prior program - Alaska Communications' board directed management to acquire up to 1M shares under the previously approved share repurchase program authorized in March 2017. This program is effective through December 31, 2019. The board views this step as "one aspect of its capital allocation plan to create long-term shareholder value. "
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KFY | Hot Stocks16:09 EDT Korn/Ferry reports Q4 fee revenue $490.8M
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AIRG | Hot Stocks16:07 EDT Airgain launches testing laboratory for 5G mmWave solutions - Airgain announced the introduction of its new testing laboratory, designed specifically to meet the challenges inherent in the development of solutions supporting new 5G mmWave networks.
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HOLX | Hot Stocks16:05 EDT Hologic enters exclusive negotiations to acquire SuperSonic Imagine for $85M - Hologic announced that it has made a binding offer to acquire France's SuperSonic Imagine, and that it has entered into an exclusive negotiation agreement with the company and its main shareholders toward that end. Under the terms of the binding offer, Hologic has agreed to acquire SuperSonic Imagine's outstanding shares at a price of EUR1.50 per share. This price corresponds to approximately $39M for all outstanding shares, or approximately $42M assuming all outstanding warrants and options with an exercise price lower than EUR1.50 are exercised. In addition, Hologic would make available funds to repay SuperSonic Imagine's net debt in an amount not to exceed $43 million, equating to a maximum enterprise value of $85M.
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ARWR | Hot Stocks16:04 EDT Arrowhead Familial Chylomicronemia Syndrome treatment granted orphan status - Arrowhead's treatment of Familial Chylomicronemia Syndrome was granted FDA orphan designation, according to a post to the agency's website. Reference Link
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LLL HRS | Hot Stocks15:21 EDT DOJ to approve L3 Technologies, Harris merger with divestiture condition - The Department of Justice announced that it is requiring Harris Corporation (HRS) and L3 Technologies (LLL) to divest Harris's night vision business in order to proceed with their merger. The Department further said that, without the divestiture, the proposed acquisition would eliminate competition between the only two suppliers of U.S. military-grade image intensifier tubes, which are the key component in night vision devices such as goggles and weapon sights purchased by the Department of Defense for the United States military. The Justice Department's Antitrust Division filed a civil antitrust lawsuit today in the U.S. District Court for the District of Columbia to block the proposed merger. At the same time, the Department filed a proposed settlement that, if approved by the court, would resolve the competitive harm alleged in the lawsuit. Under the terms of the proposed settlement, Harris and L3 must divest Harris's entire night vision business, including its manufacturing facility in Roanoke, Virginia, to an acquirer approved by the United States.
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KHC | Hot Stocks15:18 EDT S&P downgrades Kraft Heinz rating to 'BBB-/A-3' - S&P Global Ratings announced that it lowered its long-term and short-term ratings on Kraft Heinz to 'BBB-/A-3' from 'BBB/A-2' and removed the ratings from CreditWatch. "Our view of the company's business is diminished, including our expectation that certain key brands are unlikely to grow sales without discounting or successful innovation--which has not historically been a company strength--and doubts about the long-term success of the 3G cost-cutting strategy. We also believe there are governance deficiencies around internal controls, poor post-Kraft integration cost takeout planning, and the ongoing SEC investigation. Our base-case forecast does not anticipate a substantial drop from the company's rebased $6.4B mid-point EBITDA, which, in conjunction with the $1.1 billion annual dividend cut, should enable Kraft Heinz to repay debt and strengthen credit metrics. Its portfolio--while lacking solid growth prospects--should still throw off significant cash flow over the next two years," S&P stated.
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WMT | Hot Stocks14:39 EDT Walmart announces to pay $282.7M in settlement with DOJ and SEC - Walmart announced that it has entered into a global settlement with the U.S. Department of Justice and the Securities and Exchange Commission that resolves a more than seven-year investigation into the company's compliance with the U.S. Foreign Corrupt Practices Act. The global resolution ends all FCPA-related investigations or inquiries into Walmart and its subsidiaries by the DOJ and the SEC, the company said. Walmart agreed to pay a total amount of $282.7M consisting of the following: a $137.96M penalty to the DOJ and $144.69M in disgorgement of profits plus interest to the SEC. A $4.3M penalty, including forfeiture, against WMT Brasilia S.a.r.l. will be deducted from the amount owed by Walmart under the Non-Prosecution Agreement. In November 2017, Walmart disclosed that it had accrued approximately $283M for the DOJ and SEC resolution. "As a result, the amount will not materially impact Walmart's financial results," the company said. These agreements relate to Walmart's anti-corruption internal controls in Brazil, Mexico, India and China prior to April 2011. "Walmart, under the direction of its Audit Committee, conducted a thorough internal investigation, cooperated with the DOJ and the SEC, and took extensive steps that have established its strong Global Anti-Corruption Compliance Program. Over the past seven years, Walmart spent more than $900 million on FCPA inquiries and investigations, its Global Compliance Program and organizational enhancements. Walmart's actions were acknowledged by the DOJ and the SEC in the resolution agreements," the company said.
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WMT | Hot Stocks13:30 EDT Walmart settles with SEC, DOJ over Brazil bribery claims - The Securities and Exchange Commission charged Walmart with violating the Foreign Corrupt Practices Act, or FCPA, by failing to operate a sufficient anti-corruption compliance program for more than a decade as the retailer experienced rapid international growth. Walmart agreed to pay more than $144M to settle the SEC's charges and approximately $138M to resolve parallel criminal charges by the U.S. Department of Justice for a combined total of more than $282M. According to the SEC's order, Walmart failed to sufficiently investigate or mitigate certain anti-corruption risks and allowed subsidiaries in Brazil, China, India, and Mexico to employ third-party intermediaries who made payments to foreign government officials without reasonable assurances that they complied with the FCPA, the SEC stated. Reference Link
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WASH | Hot Stocks13:02 EDT Washington Trust announces 4c dividend increase - The board of Washington Trust Bancorp declared a quarterly dividend of 51c per share for the quarter ending June 30. The declaration represents a 4c per share increase over the most recent quarterly dividend rate. The dividend will be paid July 12 to shareholders of record on July 1.
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LWAY | Hot Stocks13:00 EDT Lifeway Foods jumps almost 25% before being halted - Lifeway Foods, a U.S. supplier of fermented dairy and vegan probiotic products, jumped 24.57% before being halted after it announced it plans to enter the cannabidiol, or CBD, market, once it is legalized at the federal level by the FDA. The company is planning to enter the market with Plantiful + CBD, an infused version of Lifeway's probiotic plant-based beverage.
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LWAY | Hot Stocks12:58 EDT Lifeway Foods plans to enter CBD market with Plantiful + CBD drinkables - Lifeway Foods announced it plans to enter the growing $10B+ cannabis market through Plantiful + CBD, a cannabidiol, commonly known as CBD, infused version of Lifeway's probiotic plant-based beverage, once it is legalized at the federal level by the FDA. Lifeway is also planning to file a comment in support of the FDA crafting a science-based structure to support the sale of products containing CBD.
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NVO | Hot Stocks12:52 EDT Novo Nordisk announces E.U. marketing authorization for Esperoct - Novo Nordisk announced that the European Commission has granted marketing authorization for Esperoct for the treatment of adolescents and adults with haemophilia A. The authorization covers all 28 European Union member states. Esperoctis the brand name for turoctocog alfa pegol, N8-GP. Esperoctis indicated for prophylaxis and on-demand treatment of bleeding as well as for surgical procedures in adolescents and adults with haemophilia A. Novo Nordisk expects to launch Esperoctin the first European countries during the second half of 2019.
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AAPL | Hot Stocks12:33 EDT Apple issues voluntary recall of certain older generation MacBook Pro units - Apple announced a voluntary recall of a limited number of older generation 15-inch MacBook Pro units which contain a battery that may overheat and pose a safety risk. The units were sold primarily between September 2015 and February 2017 and can be identified by their product serial number. Apple is asking customers to stop using affected 15-inch MacBook Pro units. Customers should visit apple.com/support/15-inch-macbook-pro-battery-recall for details on product eligibility and how to have a battery replaced, free of charge.
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CMCSA... | Hot Stocks12:04 EDT Comcast to launch Amazon Music on Xfinity services - Comcast (CMCSA) announced the launch of Amazon Music (AMZN) on Xfinity X1 and Xfinity Flex, which the company said is "the first time the ad-free and on demand streaming service will be available directly on the TV through a pay-TV provider." Rolling out over the next few weeks, Amazon Music "will be delivered over the Internet and accessible on X1 right alongside all of the live, on demand, and web content already available on the platform," Comcast said. Additionally, Amazon Music is now available on Xfinity Flex, Comcast's recently launched service for Internet-only customers, the company noted.
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DWT | Hot Stocks12:00 EDT Britannia Bulk falls -13.3% - Britannia Bulk is down -13.3%, or -$1.08 to $7.04.
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JDST | Hot Stocks12:00 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares falls -13.9% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is down -13.9%, or -$4.74 to $29.46.
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PIR | Hot Stocks12:00 EDT Pier 1 Imports falls -24.6% - Pier 1 Imports is down -24.6%, or -$3.33 to $10.21.
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DGAZ | Hot Stocks12:00 EDT VelocityShares 3x Inv Natural Gas ETN rises 13.7% - VelocityShares 3x Inv Natural Gas ETN is up 13.7%, or $23.87 to $198.39.
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JNUG | Hot Stocks12:00 EDT Direxion Daily Jr Gld Mnrs Bull 3X Shrs rises 13.9% - Direxion Daily Jr Gld Mnrs Bull 3X Shrs is up 13.9%, or $1.35 to $11.07.
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TUFN | Hot Stocks12:00 EDT Tufin rises 14.1% - Tufin is up 14.1%, or $3.12 to $25.31.
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AIR | Hot Stocks11:23 EDT AAR, Tawazun Economic Council and GAL sign joint repair management deal - AAR announced a new contract with Tawazun Economic Council and Global Aerospace Logistics to provide component repair management and consulting services for UAE military fleets. AAR will begin the two-year repair management contract providing complete repair loop services and supply management for GAL clients in the United Arab Emirates. AAR support will include UH-60 Black Hawk, CH-47 Chinook, Twin Otter and C-208 Caravan platforms. AAR will perform the services for GAL in Abu Dhabi, as well as at AAR headquarters in Wood Dale, Illinois.
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BGNE | Hot Stocks11:09 EDT BeiGene announces Phase 1b results of zanubrutinib with Gazyva - BeiGene announced results from an ongoing Phase 1b clinical study of its investigational BTK inhibitor zanubrutinib in combination with Gazyva in patients with relapsed/refractory or treatment naive chronic lymphocytic leukemia or small lymphocytic lymphoma, and patients with R/R follicular lymphoma. The open-label, Phase 1b trial of zanubrutinib in combination with obinutuzumab in patients with B-cell malignancies is being conducted in Australia, the United States, and South Korea, and consists of a dose-escalation phase and a dose-expansion phase in disease-specific cohorts, including patients with TN or R/R CLL/SLL and patients with R/R FL. Of the 20 patients with TN CLL/SLL, the overall response rate was 100%; the complete response rate was 30.0%; and the partial response rate was 70.0%. Median follow-up for these patients was 28.8 months. Of the 25 patients with R/R CLL/SLL, the ORR was 92.0%; the CR was 28.0%; and the PR was 64.0%. Median follow-up for these patients was 28.9 months. "These updated data provide further evidence for the rational combination of zanubrutinib and obinutuzumab, and build upon the foundation supporting our global pivotal Phase 2 trial comparing obinutuzumab plus zanubrutinib to obinutuzumab alone as a treatment for patients with R/R follicular lymphoma. It is our hope that we will continue to see deep and durable responses for these patients," said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene.
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MSON | Hot Stocks11:04 EDT Misonix up 39c to $24.17 after SEC recommends no enforcement action
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MSON | Hot Stocks11:03 EDT SEC tells Misonix investigation concluded, no enforcement action recommended - Misonix announced that it has received a letter from the Division of Enforcement of the SEC stating that the SEC has concluded its investigation of Misonix and that, based on the information it has as of the date of the letter, it does not intend to recommend an enforcement action by the SEC against Misonix. As previously disclosed, with the assistance of outside counsel, Misonix conducted a voluntary investigation into the business practices of the independent Chinese entity that previously distributed Misonix's products in China and Misonix's knowledge of those business practices, which may have had implications under the U.S. Foreign Corrupt Practices Act, as well as into various internal controls issues identified during the investigation, the company points out. On September 27, 2016 and September 28, 2016, Misonix voluntarily contacted the SEC and the Department of Justice, respectively, to advise both agencies of these potential issues and has fully cooperated with those agencies in their subsequent inquiry and investigation relating to these matters. Stavros Vizirgianakis, CEO of Misonix, commented, "We are pleased the SEC has concluded its investigation without recommending any enforcement action. Looking ahead, we remain focused on executing on our long-range strategic growth plan with the goal of creating added shareholder value and will continue to seek to operate at the highest levels of ethics, transparency and compliance while maintaining our overarching commitment to improving patient outcomes."
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AAPL | Hot Stocks10:44 EDT Apple, in letter to Lighthizer, urges U.S. not to impose additional tariffs - Apple said in a letter to United States Trade Representative Robert Lighthizer, "Thank you for this opportunity to comment on USTR's proposal to impose tariffs up to twenty-five percent duty on a fourth set of products imported from China. The proposed tariff list covers all of Apple's major products, including iPhone, iPad, Mac, AirPods, and AppleTV, as well as the parts and batteries used to repair products in the United States. The proposed tariffs also cover accessories that Apple makes for these devices, such as monitors and keyboards... We urge the U.S. Government not to impose tariffs on these products....U.S. tariffs on Apple's products would result in a reduction of Apple's U.S. economic contribution. U.S. tariffs would also weigh on Apple's global competitiveness. The Chinese producers we compete with in global markets do not have a significant presence in the U.S. market, and so would not be impacted by U.S. tariffs. Neither would our other major non-U.S. competitors. A U.S. tariff would, therefore, tilt the playing field in favor of our global competitors. We urge you not to proceed with these tariffs."
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ANIP | Hot Stocks10:33 EDT ANI Pharmaceuticals announces FDA approval for Vancomycin supplement - ANI Pharmaceuticals announced that it has received FDA approval of its Prior Approval Supplement for Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 ml, indicated for the treatment of various infections. ANI intends to launch the product prior to October. "In order to assist patients and prescribers with dosing flexibility, ANI will commercialize Vancomycin for Oral Solution, now with a mixed berry flavor, in three packaging configurations - 80 mL, 150 mL and 300 mL," the company said. Vancomycin for Oral Solution will compete in a current market estimated to exceed $450M annually, it added.
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ACRS | Hot Stocks10:31 EDT FDA says Aclaris ad makes false or misleading claims about Eskata - The FDA sent a letter to Aclaris stating, "The Office of Prescription Drug Promotion, or OPDP, of the FDA reviewed a direct-to-consumer video of an interview featuring a paid Aclaris spokesperson regarding Eskata, as well as the corresponding script submitted by Aclaris under cover of Form FDA 2253. The video was originally broadcast on ABC's The View on September 19, 2018 and can also be accessed through the Eskata Facebook page and the Aclaris LinkedIn page, both submitted by Aclaris under cover of Form FDA 2253. The video makes false or misleading claims and/or representations about the risks associated with and the efficacy of Eskata. Thus, the video misbrands Eskata... and makes its distribution violative. This video is especially concerning from a public health perspective because it fails to include information regarding the serious risks associated with Eskata, which bears warnings and precautions related to the risks of serious eye disorders... in the case of exposure to the eye and severe skin reactions including scarring... OPDP requests that Aclaris immediately cease violating the FD&C Act." Reference Link
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KR | Hot Stocks10:12 EDT Kroger says Q2 same-store-sales 'trending better' than Q1 - Kroger CEO Rodney McMullen said on today's earnings call that the company's same-store-sales in Q2 are "trending better" than in Q1. "We know we can do better" on same-store-sales, McMullen said.
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EMN | Hot Stocks10:07 EDT Eastman Chemical to acquire INACSA, terms not disclosed - Eastman Chemical Company announced that it has entered into a definitive agreement to acquire Industrias del Acetato de Celulosa S.A., or INACSA, a Spanish producer of cellulosic yarn. The INACSA yarn business and assets are expected to support continued growth of Naia cellulosic yarn for the apparel market and will become part of the global Fibers segment supply base. Subject to receipt of required regulatory approvals and satisfaction of other customary closing conditions, Eastman will acquire the entire yarn business and assets from INACSA, including the plant and assets in La Batlloria, Spain, formulations and intellectual property and customer contracts. The acquisition is expected to be completed in Q3. Terms of the transaction were not disclosed.
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CNO | Hot Stocks10:01 EDT CNO Financial names Tim Bischof as Chief Risk Officer - CNO Financial announced the appointment of Tim Bischof as chief risk officer, effective immediately. Bischof has been CNO's senior vice president, corporate actuary and enterprise risk management since 2013. He will continue in that role in addition to the promotion to chief risk officer, the company said.
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ULBI | Hot Stocks10:00 EDT Ultralife awarded $10M communications systems IDIQ contract - Ultralife has received a fixed price, indefinite-delivery/indefinite-quantity contract for purchases not to exceed $9.986M from the Naval Air Warfare Center Aircraft Division for our Universal Vehicle Adaptors in support of the Family of Special Operations Vehicles Ground Mobility Vehicle and Mine Resistant Ambush Protected platforms. The award is for five years with the amounts and timing of deliveries based on program requirements. Also, an initial delivery order has been received for approximately $1.4M and shipments in 2019.
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CCL | Hot Stocks10:00 EDT Carnival falls -11.7% - Carnival is down -11.7%, or -$6.16 to $46.68.
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CUK | Hot Stocks10:00 EDT Carnival plc falls -11.9% - Carnival plc is down -11.9%, or -$6.13 to $45.55.
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PIR | Hot Stocks10:00 EDT Pier 1 Imports falls -14.9% - Pier 1 Imports is down -14.9%, or -$2.01 to $11.53.
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SDRL | Hot Stocks10:00 EDT Seadrill rises 8.2% - Seadrill is up 8.2%, or 27c to $3.57.
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IAG | Hot Stocks10:00 EDT IAMGold rises 9.1% - IAMGold is up 9.1%, or 27c to $3.28.
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JNUG | Hot Stocks10:00 EDT Direxion Daily Jr Gld Mnrs Bull 3X Shrs rises 11.5% - Direxion Daily Jr Gld Mnrs Bull 3X Shrs is up 11.5%, or $1.12 to $10.84.
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CUK | Hot Stocks09:47 EDT Carnival plc falls -11.6% - Carnival plc is down -11.6%, or -$5.97 to $45.71.
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PIR | Hot Stocks09:47 EDT Pier 1 Imports falls -12.3% - Pier 1 Imports is down -12.3%, or -$1.66 to $11.88.
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JDST | Hot Stocks09:47 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares falls -12.9% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is down -12.9%, or -$4.40 to $29.80.
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ZNH | Hot Stocks09:47 EDT China Southern Airlines rises 7.4% - China Southern Airlines is up 7.4%, or $2.47 to $35.94.
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IAG | Hot Stocks09:47 EDT IAMGold rises 12.0% - IAMGold is up 12.0%, or 36c to $3.37.
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JNUG | Hot Stocks09:47 EDT Direxion Daily Jr Gld Mnrs Bull 3X Shrs rises 12.8% - Direxion Daily Jr Gld Mnrs Bull 3X Shrs is up 12.8%, or $1.24 to $10.96.
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PHUN | Hot Stocks09:44 EDT Phunware says Phun utility tokens now available in select international markets - Phunware announced Phun utility tokens are now available for purchase in select international markets. "While Phun is a utility token that enables consumers to monetize their digital activity as they engage in profitable behavior with brands, PhunCoin remains a compliant security token that enables consumers to monetize their digital identity and offers token holders a PhunCoin dividend...Given the regulatory environment, Phun will initially only be available outside the United States and Canada," the company said.
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JSYN PECK | Hot Stocks09:30 EDT Jensyn Acquisition completes business combination with Peck Electric - Jensyn Acquisition Corp (JSYN) and Peck Electric (PECK) announced that they completed their previously announced combination. The business combination was approved by Jensyn's stockholders on June 19, 2019, with more than 87% of the voted shares voting in favor of the business combination. Holders of 492,037 shares of Jensyn common stock exercised their redemption rights in connection with the business combination. As a result of the business combination, Peck Electric Co. has become a wholly-owned subsidiary of Jensyn named "The Peck Company Holdings, Inc.", whose common shares will commence trading on the Nasdaq Capital Market under the symbol "PECK." Additionally, the stockholders of Peck Electric Co. have exchanged their shares in Peck Electric Co. for 3,234,501 shares of Jensyn common stock representing approximately 59% of Jensyn's outstanding shares. If Jensyn's adjusted EBITDA is $5,000,000 or more for the twelve-month period following the closing of the business combination or the closing price of Jensyn's common stock is $12.00 or more the stockholders of Peck Electric Co. are entitled to an additional 898,473 shares of Jensyn common stock. The senior management of Peck will replace Jensyn's existing management team following the closing of the business combination. Jeff Peck will serve as the Company's CEO.
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SFS APO | Hot Stocks09:28 EDT Smart & Final Stores announces completion of previously announced transaction - Smart & Final Stores (SFS) and First Street Merger Sub, an entity controlled by funds managed by affiliates of Apollo Global Management (APO), announced the successful completion of the previously announced transaction whereby the Purchaser acquired all of the outstanding shares of common stock of Smart & Final. The transaction was effected through a previously announced cash tender offer for all of the outstanding shares of common stock of Smart & Final followed by a merger. The tender offer expired at 5:00 p.m., New York City time, on June 17, 2019 and the Purchaser accepted all of the tendered shares for payment. On June 20, 2019, the Purchaser made payment for the tendered shares and, concurrently therewith, Smart & Final merged with the Purchaser. As a result of the tender offer and the merger, Smart & Final became a privately-held, indirect wholly-owned subsidiary of the Apollo Funds and Smart & Final's common stock ceased trading on the New York Stock Exchange. Each outstanding share of common stock that was not validly tendered in the tender offer was cancelled and converted into the right to receive an amount in cash equal to the $6.50 price per share net to the holder thereof, subject to reduction for any applicable withholding taxes in respect thereof, without interest.
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EFX | Hot Stocks09:27 EDT Equifax, GIACT Systems announce strategic alliance - GIACT Systems and Equifax announced a strategic alliance that will pair both companies to help confront the challenges of identity verification and fraud prevention. The Epic Platform from GIACT offers a way for companies to help protect against multiple types of fraud across the customer lifecycle, including solutions to address real-time enrollment, payment, identity, compliance, and mobile fraud prevention. Equifax arms the fraud detection and identity space with consumer identity and behavioral data, combined with technology and analytics.
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GLG | Hot Stocks09:25 EDT Bat Group enters into MoU with regional commercial bank to expand business - Bat Group announced that the Company, through its wholly owned subsidiary Beijing Tianxing Kunlun Technology Co., Ltd., has entered into a strategic cooperation memorandum of understanding with Shuangtaizi Rural Credit Cooperative Union, a regional commercial bank based in Panjin City, Liaoning, to accelerate the Company's business expansion to new regions. Pursuant to the Memorandum, SRCCU agrees to issue the Company a credit line of up to $580M. The Company agrees to use the proceeds from the line to purchase luxury cars, expand its operations and satisfy other working capital needs. This Memorandum is a framework agreement only. SRCCU is not committed to provide any line or credit to the Company pursuant to Memorandum. The terms of the draw under the line of credit will be agreed by the parties based on negotiation.
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RTTR | Hot Stocks09:24 EDT Ritter Pharmaceuticals remains 'on track' with Phase 3 trial of RP-G28 - Ritter Pharmaceuticals provided an update of its Phase 3 clinical trial and regulatory efforts. The 557-subject Phase 3 clinical trial of RP-G28, known as "Liberatus", remains on track with anticipated top-line data readout in early Q4 2019. As previously reported, all subjects have completed enrollment with last-patient-last-visit expected in July 2019. The study remains blinded and unblinding and analysis of the data will not take place until patients have completed all protocol periods and the database has been locked. The Company has been in dialog with the FDA to confirm that the analyses defined in the Statistical Analysis Plan for the Liberatus Phase 3 clinical trial would be supported by the FDA. The Company has achieved alignment over key elements of the study's SAP, including the primary endpoint, secondary endpoints and other critical components.
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DTE | Hot Stocks09:23 EDT DTE Energy secures $1.5M in grants to provide two schools with electric buses - DTE announced that its partnership with Ann Arbor and Roseville schools was selected by the State of Michigan to receive $1.5M in funding for six Thomas Built "Jouley" Buses powered by Proterra, as well as equipment to charge them.The Ann Arbor Public Schools will receive four buses and Roseville Community Schools will receive two buses. DTE will work with both districts to ensure the associated electric infrastructure is constructed to support the project. DTE also will partner with the schools to implement a vehicle-to-grid study, which will allow the utility to better understand the effects of battery storage technology.
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RST | Hot Stocks09:23 EDT Rosetta Stone, HIAS partner to offer refugee populations language learning - Rosetta Stone and HIAS announced a new partnership that will make language learning software available to help in the refugee resettlement process and to encourage cross cultural exchanges between refugee populations and hosts who assist refugees. Rosetta Stone is providing 1,500 1-year licenses to HIAS' affiliate network staff, resettled refugee populations, and volunteers. HIAS partners with Airbnb's Open Homes program to connect refugee populations to temporary housing at no cost. Whether it's a family or an individual starting a new life in a community, Open Homes lets hosts offer their space to newcomers. HIAS' affiliate network will be offering a portion of the Rosetta Stone licenses to hosts that connect with a HIAS affiliate to sign up for Open Homes. Rosetta Stone's mobile app allows for on-the-go access to lessons and activities in 24 languages and will help refugees as they begin their new lives in new communities globally, as well as the volunteers and hosts who assist refugees in the resettlement process. As part of the donation, Rosetta Stone will provide HIAS employees with training on how to effectively administer language learning to users for maximum effectiveness.
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TGTX | Hot Stocks09:21 EDT TG Therapeutics presents data on umbralisib at ICML conference - TG Therapeutics announced data from four presentations, including three oral presentations and one poster presentation, at the 15th International Conference on Malignant Lymphoma. Highlights from the oral presentations include: Oral Presentation Title: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib in Patients with Chronic Lymphocytic Leukemia Who Are Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy: This presentation includes data from patients with CLL who are intolerant to prior BTK or PI3K delta inhibitor therapy who were then treated with single agent umbralisib. To be eligible for the study patients had to have received prior treatment with a BTK inhibitor or a PI3K delta inhibitor and discontinued therapy due to intolerance. Fifty-one patients were evaluable for safety of which 50 were evaluable for Progression Free Survival. Highlights: Umbralisib demonstrated a favorable safety profile in patients intolerant to prior BTK or PI3K delta therapy; Only 12% discontinued due to an umbralisib adverse event, of which only one patient discontinued due to a recurrent adverse event previously experienced with prior kinase inhibitor therapy; In this relapsed/refractory CLL population, 67% had a high-risk molecular / genetic marker and 6% had an ibrutinib resistance mutation, the estimated median progression free survival was 23.5 months; Median overall survival has not been reached with a median follow-up of 14 months; As of the cut-off date, 58% of patients have been on umbralisib for a duration longer than their prior BTK or PI3k inhibitor. Oral Presentation Title: Phase I/II Study of Umbralisib in Combination with Ublituximab and Pembrolizumab in Patients with Relapsed/Refractory CLL and Richter's Transformation: This oral presentation includes data from patients with relapsed or refractory CLL or RT treated with the triple combination of ublituximab, umbralisib, and pembrolizumab. Patients with CLL received 2 cycles of the U2 regimen before pembrolizumab was added for an additional 4 cycles, followed by umbralisib maintenance. Patients with RT received U2 + pembrolizumab for the first 4 cycles, followed by U2 maintenance. Twenty patients were evaluable for safety and 19 were evaluable for efficacy. Data highlights include:The triple combination was well tolerated, with immune mediated toxicities not appearing above what would be expected with either umbralisib or pembrolizumab alone; In this heavily pre-treated cohort with a median of 2 prior lines of therapy: 91% Overall Response Rate in patients with relapsed/refractory CLL, 83% ORR in BTK refractory CLL patients, with 4 of 5 responders achieving a response to U2 alone at the patient's first efficacy assessment, prior to the addition of pembrolizumab, 38% ORR in RT, with two durable complete responses; 1 subject relapsed post-CAR-T in CR for 12 months and 1 subject relapsed post-transplant continuing on study in CR now 20+ months. Additionally, data from the UNITY-NHL MZL cohort and data from TG-1801, the Company's first-in-class anti-CD47-CD19 bispecific antibody, will be presented during ICML. These presentations were recaps and have been previously presented.
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CDE | Hot Stocks09:15 EDT Coeur, Alianza sign LOI to explore Tim high-grade silver-lead-zinc property - Alianza Minerals has signed a Letter of Intent with Coeur Exploration to explore the road-accessible Tim Property in southern Yukon Territory. Exploration at the Tim Property is targeting high-grade silver-lead-zinc mineralization similar to that being mined by Coeur at its Silvertip mine located 12 km to the south of the Tim Property. Coeur can earn a 51% interest in the property by funding $3.5M in exploration over 5 years and making staged cash payments totalling $275,000. Coeur can elect to complete the option to earn 80% in the property by funding a positive feasibility study in the following three years and making annual payments of $100,000. The 2019 exploration program at the Tim Property will target high-grade silver-lead-zinc carbonate replacement mineralization similar in style to that found at Silvertip.
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OPTT | Hot Stocks09:13 EDT Ocean Power receives U.S. patent for Power Take-Off System - Ocean Power Technologies announced that the Company has received a new U.S. patent for its Power Take-Off System which is the mechanical heart of the PB3 PowerBuoy. Ocean waves that pass-by the PowerBuoy create a relative linear motion between the float and the spar components of the PB3. The PTO system takes the linear motion of the float through the input shaft and converts it into rotary motion via a ball-screw. The ball-screw drives a generator that produces electrical power thus completing the wave energy to electrical energy conversion. The PTO system has a mechanical efficiency of more than 90% and an expected minimum three years between service for continuous operation in the most severe environments, including the North Sea. The PTO system also contains a mechanical brake for locking the buoy during transportation and under storm conditions to prevent damage to the components. This patent includes two different designs of the PTO system. The first design offsets the input rod and the ball-screw axes, which is currently being manufactured and deployed. The second design is based on a concentric input rod and ball-screw arrangement, which further simplifies the system and may be used in future PB3 PowerBuoy deployments.
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AYI | Hot Stocks09:12 EDT Acuity Brands acquires WhiteOptics, terms not disclosed - Acuity Brands announced it has acquired WhiteOptics, a New Castle, DE-based manufacturer of advanced optical components used to reflect, diffuse and control light for LED lighting used in commercial and institutional applications. The acquisition is not expected to materially impact the Company's fiscal 2019 consolidated financial performance. Terms of the acquisition were not disclosed.
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TPTX | Hot Stocks09:10 EDT Turning Point initiates Phase 2 registrational portion of TRIDENT-1 study - Turning Point Therapeutics announced initiation of the registrational Phase 2 portion of its TRIDENT-1 clinical study of patients with ROS1+ advanced non-small cell lung cancer and TRK+ advanced solid tumors. Patients will be treated with Turning Point's lead investigational kinase inhibitor, repotrectinib, which has been studied in more than 80 patients in the ongoing Phase 1 portion of the study. The study is planned for global site expansion during 2019 and into 2020 at approximately 100 sites. Turning Point Therapeutics expects to enroll approximately 310 patients across five registrational cohorts and anticipates reporting early interim results from initial patients during the second half of 2020. Screening for the study will involve genetic testing of a sample of the patient's tumor to identify the presence of genetic alterations, such as ROS1 or NTRK, to determine eligibility for the trial. Repotrectinib is being developed as a precision therapy targeting ROS1 and NTRK-driven cancers. Patients eligible for the study will receive the likely recommended Phase 2 dose of 160 mg of repotrectinib once or twice daily, pending upcoming feedback from the FDA.
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LRAD | Hot Stocks09:08 EDT LRAD Corporation receives $850,000 in orders for Japan, Canada - LRAD Corporation announced mass notification public safety orders for Japan and multiple islands in the Asia Pacific region, and an acoustic hailing device systems order for wildlife preservation from Canada. The AHD systems will be integrated with avian radar and used to locate and deter birds from landing on tailing ponds at a mining operation. In Japan, the Company's SoundSaber-X systems will be installed on buildings in certain urban areas to provide visually discrete public safety mass notification. The Asia Pacific islands' SoundSaber-X installations will help protect residents by broadcasting voice warning notifications and evacuation instructions during severe weather and tsunami threats.
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LODE | Hot Stocks09:05 EDT Comstock Mining expects to close on Silver Springs sale this summer - The Company's annual operating expenses are planned at $3.8M, and effective June 1, 2019, approximately $2.2M of that amount, prospectively, is being reimbursed under the existing Tonogold Option Agreement and the new Tonogold agreement to purchase Lucerne, resulting in more than $1M in additional, annualized savings. The transaction to purchase the Lucerne properties is expected to close on or before August 30, and the Company expects to receive an additional non-refundable deposit this month. The Company's second half 2019 plans include advancing the commercialization of certain mining and processing technologies that the Company has been collaborating on, with new partners such as MCU and Oro Industries Inc., and others, and includes reclamation and enhanced mineral recoveries that present nearer term revenue opportunities for us and potentially enhance the economic feasibilities of our existing properties. The Company expects to close on the sale of the Silver Springs properties this summer, likely on or before September, 2019, for total net proceeds of over $10M, in addition to the over $9M in total remaining net cash proceeds from the sale of Lucerne remaining, expected on or before August 30, 2019. The Dayton resource area, south of Virginia City in Lyon County, Nevada, ranks as the Company's top exploration and mine development target. The Company is developing a completely new geological interpretation that will be used for a new resource estimate. The new geological interpretation is also being used to design phased drilling programs in with high-potential for additional mineral resources. Multiple layout plans for the mine and corresponding processing facilities have been conceptually developed and located on lands 100% privately held by the Company, thus simplifying and shortening the critical permitting chain. The Company plans to issue a new, stand-alone Dayton resource technical report, followed by a preliminary economic assessment. The Company also expects to announce additional ventures and alliances, all designed for profitable revenue growth, during the third and fourth quarters of 2019. The ventures and our strategic partners will be showcased during our annual meeting, planned for September 2019, at the Gold Hill Hotel in Gold Hill, Nevada.
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AMZN | Hot Stocks09:04 EDT Amazon.com unveils Off-to-College store - Amazon unveils its Off-to-College store, the ultimate destination for your college shopping needs. Available on desktop and the Amazon App, students can browse a wide range of essentials with low prices for their dorm, classes and extracurricular activities in one place, without sacrificing valuable summer vacation time. New this year, Amazon enlisted the help of Ava Phillippe to share her own dorm room must-haves. Customers can shop Ava's list or browse college influencer-curated style guides, including earthy artsy, casual throwback, modern minimal and eclectic chic.
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ORCL... | Hot Stocks09:04 EDT Fly Intel: Pre-market Movers - UP AFTER EARNINGS: Oracle (ORCL), up 7%... American Outdoor Brands (AOBC), up 8%. ALSO HIGHER: Aecom (ACM), up 2% after receiving a letter from activist investor Starboard urging a strategic review... CommScope (COMM), up 7% after Goldman Sachs analyst Mark Delaney upgraded shares to Buy from Neutral while lowering his price target for the shares to $19 from $20. The company can expand margins from a combination of lower input costs, as DRAM pricing and copper pricing have both fallen, and cost synergies from the Arris transaction, Delaney tells investors in a research note. DOWN AFTER EARNINGS: Carnival (CCL), down 9%... Darden (DRI), down 5%... Pier 1 Imports (PIR), down 12%. ALSO LOWER: Scholar Rock (SRRK), down 12% after a 3M share secondary priced at $15.00 per share... Cryoport (CYRX), down 6% after a 3.75M share spot secondary priced at $17.00 per share.
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LODE | Hot Stocks09:03 EDT Comstock says NDEP approves reduction in Lucerne reclamation bonding requirement - The Nevada Division of Environmental Protection's Bureau of Mining Regulation and Reclamation approved a reduction in the Company's Lucerne reclamation bonding requirement from several successful environmental reclamation and restoration efforts. Along State Route 342, just south of Gold Hill, Nevada, the Company also completed a variety of reclamation and/or environmental restorations, using progressive earthwork. CEO Corrado De Gasperis stated, "This restoration work was performed concurrently with mining from 2013 through 2015, and our reclamations were innovative, timely, efficient and especially effective for the regrading and revegetation efforts. The current reclamation obligation has been reduced down to $6.75M from over $7.10M." In 2015 and 2017, the Company received Nevada Excellence in Mine Reclamation Awards from a committee comprised of NDEP's BMRR, Nevada Division of Minerals, Nevada Department of Wildlife, Bureau of Land Management Nevada, and the U.S. Forest Service. In 2018, the Company also received the U.S. Department of the Interior BLM's Reclamation and Sustainable Mineral Development Award.
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TWLO GE | Hot Stocks09:03 EDT Twilio adds Jeff Immelt to Board of Directors - Twilio (TWLO) is pleased to welcome Jeff Immelt, former chairman and CEO of General Electric (GE) and current venture partner at New Enterprise Associates, to the Twilio Board of Directors. Immelt brings nearly 20 years of executive and boardroom experience at the helm of a world-leading global enterprise to Twilio.
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DEA | Hot Stocks09:03 EDT Easterly Government Properties awarded 20 year lease for FDA laboratory - Easterly Government Properties has been awarded a 20 year non-cancelable lease for a 162,000-square foot FDA laboratory in Atlanta, Georgia. With this lease award, Easterly now has three active development projects totaling approximately 291,000 square feet, all for the use of the FDA.
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SFS | Hot Stocks09:03 EDT Smart & Final Stores trading halted, news dissemination
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AMZN | Hot Stocks09:02 EDT AmazonFresh expands to Las Vegas with one and two hour delivery - Amazon announced that AmazonFresh has expanded to Las Vegas. Now Prime members in Las Vegas can shop tens of thousands products from meat and seafood to fresh produce and everyday essentials for ultrafast one- and two-hour delivery from AmazonFresh.
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LODE | Hot Stocks09:02 EDT Comstock Mining calls Precious claimes 'completely without merit' - The Company previously announced, and has included in today's first quarter Form 10-Q filing, that on May 14, 2019, the Third Judicial District Court of the State of Nevada ruled in favor of the Company and Lyon County on the one remaining Due Process rights claim associated with the Lyon County Board of Commissioners Master Plan amendment and zone change associated with certain mineralized properties within the Company's Dayton Resource Area, just south of the Company's Lucerne properties and near Silver City, Nevada. In addition, on May 21, 2019, the First Judicial District Court of the State of Nevada, in and for Storey County, favorably granted us our Motion for the Plaintiff to file a "more definite statement." Precious refiled their complaint on June 5, 2019. The Company believes that the Precious claims are completely without merit.
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LODE | Hot Stocks09:01 EDT Comstock Processing to form joint venture with Mercury Clean Up - Tonogold recently accelerated, and the Company has received, $3.92M in non-refundable Convertible Preferred Stock. The $3.92M ultimately converts at a price being the lowest of Tonogold's 20-day volume weighted closing price prior to conversion, most recent private placement, or initial public offering price. Comstock Processing LLC, a new wholly owned subsidiary the Company that includes all of the assets at the American Flat campus, including crushing, leaching, Merrill-Crowe metallurgical processing and the Company's various metallurgical laboratories, has pursued, and the Board has approved, the formation of a Joint Venture with Mercury Clean Up, with proprietary technology for placer mining gold and silver bearing materials containing mercury. The Company expects to finalize the terms of the Joint Venture this month and announce the details. The Company will form another entity called Comstock Mercury Remediation LLC, or a similar name, that will represent the actual 50-50 Joint Venture, with final proof of concept, mining and remediation occurring on the Comstock. The Company will also own a direct stake in MCU.
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LODE | Hot Stocks08:58 EDT Comstock Mining advances realignment in regards to Lucerne properties - Comstock Mining announced progress on a number of strategic initiatives and corporate activities. During the first quarter of 2019, the Company's Board of Directors approved the sale of the Lucerne mine and a strategy focused on high-value, high cash-generating, precious metal-based activities, including, but not limited to, metals exploration, engineering, resource development, economic feasibility assessments, mineral production, metal processing and related supply chain acquisitions and ventures for environmentally-friendly, conservation-based, economically enhancing mining technologies and processes. The company has now completed the realignment such that all of the Lucerne properties are now wholly owned or controlled by Comstock Mining LLC, the entity that Tonogold Resources will acquire in purchasing the Lucerne properties.
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PGNX | Hot Stocks08:36 EDT Progenics to initiate basket trial by year-end for expanded label for AZEDRA - Progenics Pharmaceuticals announced that the Company has reached alignment with the U.S. Food and Drug Administration on the clinical development plan to pursue a tissue agnostic indication to support an expanded label for AZEDRA for the treatment of patients with unresectable or metastatic neuroendocrine tumors who are MIBG avid. Following a Type B meeting with the FDA, the Company plans to conduct a basket study that will evaluate AZEDRA in patients with NETs that are MIBG avid, including gastroenteropancreatic neuroendocrine tumors and other NETs, with a dosing regimen that potentially enables outpatient administration. AZEDRA is the first and only approved therapy in the U.S. for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. NETs are a group of rare tumors of neural crest origin, most commonly found in the gastrointestinal or respiratory tracts, although they may also be found in the central nervous system, thyroid gland, skin, breast, colon, and urogenital system, including prostate cancer, among other locations. NETs overexpress the norepinephrine reuptake transporter on their cell surface. MIBG is a known substrate for the transporter and, therefore, MIBG avidity can be used to enrich for patients who are most likely to respond to AZEDRA therapy. NETs are considered rare tumors, although the incidence has continued to increase in the last 10-15 years, with approximately 12,000 patients being diagnosed in the U.S. each year. The basket study is expected to enroll approximately 120 patients at sites in the U.S. Progenics plans to initiate the study by the end of 2019.
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ALL | Hot Stocks08:34 EDT Allstate reports May 2019 catastrophe loss estimate $473M - Allstate announced estimated catastrophe losses for May of $473M pre-tax, $374M after-tax. Catastrophe losses occurring in May comprised 14 events at an estimated cost of $504M pre-tax, $398M after-tax, partially offset by favorable reserve reestimates of prior period catastrophe losses. One severe weather event which included tornadoes, wind and hail, primarily impacting the Midwest, accounted for approximately 50% of May estimated catastrophe losses. April estimated catastrophe losses were $290M pre-tax, $229M after-tax.
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TGB | Hot Stocks08:34 EDT Taseko Mines submits aquifer protection permit for Florence project to ADEQ - Taseko Mines announced that it has submitted the aquifer protection permit, or APP, amendment application to the Arizona Department of Environmental Quality, or ADEQ. The APP is one of two key permit amendments which are required for commercial production at the company's Florence Copper Project. The permit amendment application for the underground injection control permit will be made to the U.S. Environmental Protection Agency in the coming weeks.
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CLSN | Hot Stocks08:34 EDT Celsion receives IRB approval to begin clinical study of ThermoDox plus MR-HIFU - Celsion Corporation announces that the University Medical Center Utrecht in the Netherlands has received Institutional Review Board approval to begin a Phase I study to determine the safety, tolerability and feasibility of ThermoDox in combination with Magnetic Resonance Guided High Intensity Focused Ultrasound hyperthermia and cyclophosphamide therapy for the local treatment of the primary tumor in metastatic breast cancer. The secondary objective of this study is to assess radiological objective response of distant metastases and of the primary breast tumor. The investigator sponsored study - image-guided targeted doxorubicin delivery with hyperthermia to optimize loco-regional control in breast cancer; the i-GO Feasibility Study - will be conducted at University Medical Center Utrecht and will enroll up to 12 newly diagnosed mBC patients. Study subjects will receive up to six cycles of the following regimen at three-week intervals: 60 minutes of MR-HIFU hyperthermia at 40oC to 42oC delivered to the primary tumor; 50 mg/m2 of ThermoDox as a 30-minute intravenous infusion during hyperthermia; and 600 mg/m2 of cyclophosphamide as a 15-minute IV infusion after hyperthermia. Investigators will use the Profound Medical Sonalleve MR-HIFU Breast Tumour Therapy System, which integrates high-intensity phased array focused ultrasound transducers with a Philips Achieva MRI system. The study is being funded by the Dutch Cancer Society, the Center for Translational Molecular Medicine and Friends of the UMC Utrecht,
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SGMS | Hot Stocks08:19 EDT Scientific Games Chairman acquires $2.43M worth of shares - Scientific Games Chairman Ronald Perelman disclosed last night the purchase of 120,000 shares at price of $20.29 for a total value of $2,434,800. The purchase brought Perelman's stake in Scientific Games to 36,368,768 shares.
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ALXN | Hot Stocks08:18 EDT Alexion's Biologics License Application for Ultomiris accepted by FDA - Alexion Pharmaceuticals announced that the FDA has accepted for priority review the company's supplemental Biologics License Application for Ultomiris, the company's long-acting C5 complement inhibitor, for the treatment of people with atypical hemolytic uremic syndrome in order to inhibit complement-mediated thrombotic microangiopathy. The FDA has set a target action date of October 19 under the Prescription Drug User Fee Act. Atypical HUS is a severe and chronic ultra-rare disease that can cause progressive damage to vital organs, predominantly the kidneys, leading to kidney failure and premature death. The sBLA is based on previously announced results from the Phase 3 study of Ultomiris in people with aHUS, which met the primary endpoint of complete TMA response.
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CLGN | Hot Stocks08:15 EDT CollPlant announces corporate name change to CollPlant Biotechnologies - CollPlant announced that its corporate name has changed from "CollPlant Holdings." to "CollPlant Biotechnologies." effective on the opening of trading on June 21. The company's ADSs will continue trading on Nasdaq under the same ticker symbol.
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RNET | Hot Stocks08:13 EDT Bardasz signs reseller agreement for RigNet's Intelie suite of solutions - RigNet has signed a reseller agreement to deliver Intelie's suite of solutions to Bardasz' customers in Mexico. Intelie Live, RigNet's machine learning- based advanced predictive analytics solution will provide Oil and Gas companies in the region with real-time AI based monitoring that can capture every bit of data across distributed assets, from oil platform operations to pressure-pump engines; in order to capture, process and analyze thousands of events per second in real-time.
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XIN | Hot Stocks08:11 EDT Xinyuan Real Estate CEO Lizhou Zhang resigns, Yong Zhang succeeds - Xinyuan Real Estate announced that the board has approved Lizhou Zhang's resignation as the company's CEO and as a member of the board due to personal reasons, effective immediately. Yong Zhang will serve as both chairman and CEO of Xinyuan Real Estate going forward, effective immediately. Yong Zhang is the founder of Xinyuan Real Estate and has more than 20 years of experience in the real estate industry. He is also vice chairman of the Henan Real Estate Association.
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TACO BYND | Hot Stocks08:08 EDT Del Taco introduces signature burritos with Beyond Meat plant-based protein - Del Taco Restaurants (TACO) is now expanding its partnership with Beyond Meat (BYND) to offer the brand's 100 percent plant-based protein option in two new signature protein-packed burritos, the Beyond 8 Layer Burrito and the Epic Beyond Cali Burrito, at its more than 580 locations across the country. With the nationwide launch of its Beyond Tacos in April, Del Taco became the first national Mexican fast food chain to add a 100 percent plant-based protein option to its menu. Since then, Del Taco has sold nearly two million Beyond Tacos and Beyond Avocado Tacos, with close to 100,000 hand-sliced avocados used for the Beyond Avocado Taco alone.
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KR | Hot Stocks08:08 EDT Kroger CEO says building momentum in second year of 'Restock Kroger' - Kroger CEO Rodney McMullen said, "Because the retail industry is constantly transforming, we proactively launched Restock Kroger to deliver for our customers and shareholders. It all starts with our customer obsession, which is why Kroger is assembling a platform to deliver anything, anytime, anywhere. We are building momentum in the second year of Restock Kroger, which is off to a solid start. The entire company is focused on redefining the grocery customer experience, improved upon by exciting partnerships that will create value. We are on track to generate the free cash flow and incremental adjusted FIFO operating profit that we committed to in 2019 as part of Restock Kroger. We are confident in our ability to deliver on our plans for the year and our long-term vision to serve America through food inspiration and uplift."
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HZNP | Hot Stocks08:07 EDT Horizon Pharma initiates trial for Krystexxa combination in chronic gout - Horizon Therapeutics has initiated a clinical trial evaluating Krystexxa - pegloticase injection - in combination with methotrexate as a strategy to increase the durability of response for patients living with chronic gout refractory to conventional therapies - also known as uncontrolled gout. The trial will evaluate the use of methotrexate as an immunomodulator to meaningfully reduce immune response to Krystexxa in adult patients living with uncontrolled gout. The trial will assess whether the combination of Krystexxa with methotrexate can enhance the demonstrated response rate of Krystexxa, will confirm the safety and tolerability and provide information on the pharmacokinetics of the combined use. The primary endpoint will be the ability of Krystexxa with methotrexate versus Krystexxa alone to maintain a serum uric acid less than6 mg/dL through Month 6. The trial initiation is informed by the positive results of an independent case series which demonstrated that the use of methotrexate with Krystexxa was well tolerated and led to an improved overall response. In the trial, 135 adult patients will be randomized to receive methotrexate or placebo for four weeks and then receive treatment with Krystexxa and methotrexate or Krystexxa and placebo for 52 weeks, with the primary endpoint measured at Month 6, followed by a six-month follow-up period.
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DGLY | Hot Stocks08:06 EDT Digital Ally says pre-sales for new in-car system exceed expectations - Digital Ally announces that pre-sale demand for its newest in-car system is greater than expected, with over 70 law enforcement agencies ready to receive EVO-HD during the first phase of shipping scheduled to begin in late June. The EVO-HD is the most advanced, compact and easy to install system from Digital Ally with built-in, patented auto-activation technology.
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SPRO VRTX | Hot Stocks08:04 EDT Spero Therapeutics announces collaboration with Gates MRI to develop SPR720 - Spero Therapeutics (SPRO) announced that it entered into a collaboration with the Bill & Melinda Gates Medical Research Institute to develop SPR720 for the treatment of lung infections caused by Mycobacterium tuberculosis, an indication that is designated as a critical concern by the World Health Organization. SPR720 is an orally administered antimicrobial agent currently being developed by Spero Therapeutics for the treatment of rare non-tuberculous mycobacterial infections. Spero has granted Gates MRI an exclusive license to develop, manufacture and commercialize SPR720 for the treatment of tuberculosis in low- and middle- income countries. Gates MRI will conduct and fund preclinical and clinical studies for the development of SPR720 against TB, and also fund certain collaborative activities in furtherance of Gates MRI's charitable purposes. SPR720 was discovered by Vertex Pharmaceuticals (VRTX) and was acquired by Spero Therapeutics in 2016. Vertex and Spero have reached an agreement to enable the collaboration between Spero and the Bill & Melinda Gates Medical Research Institute for the further development of this compound in low- and middle- income countries. SPR720 is currently being evaluated in a double-blind, placebo-controlled Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of SPR720 in healthy volunteers. Spero expects to report top-line data from the Phase 1 clinical trial in the second half of 2019. Preclinical in vitro and in vivo studies have demonstrated the potency of SPR720 against clinically important mycobacteria, including NTM species Mycobacterium avium complex and Mycobacterium abscessus, as well as Mycobacterium tuberculosis. The collective data to date suggest that SPR720 has an acceptable safety profile, encouraging target pathogen efficacy, drug distribution to key sites of infection, such as the lung, and a wide therapeutic margin.
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EDNT | Hot Stocks08:04 EDT Edison Nation announces licensing of Ezy Dose Medi-Spout to Apothecary Products - Edison Nation announced that Apothecary Products has licensed the Ezy Dose Medi-Spout, a pill assisting bottle cap that utilizes patented technology to ease the swallowing of medication and vitamins.
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SMAR AMZN | Hot Stocks08:03 EDT Smartsheet achieves Amazon Web Services Government Competency status - Smartsheet (SMAR) has achieved Amazon (AMZN) Web Services - AWS - Government Competency status. This designation recognizes that Smartsheet has developed innovative technology and solutions that leverage AWS services to address the specific security needs of the U.S. Federal Government. Achieving the AWS Government Competency differentiates Smartsheet as an AWS Partner Network member, approved to deliver mission-critical workloads and applications for government customers on AWS. Smartsheet achieved "In Process" status in April as part of the Federal Risk and Authorization Management Program and is now listed in the FedRAMP marketplace for federal agencies and government contractors.
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OPK | Hot Stocks08:02 EDT Opko Health submits de novo request to FDA for 4Kscore Test - OPKO Health announces that the Company has submitted a de novo request to the U.S. Food and Drug Administration seeking regulatory clearance for the 4Kscore test. The 4Kscore test is a blood test used by health care professionals to assess a patient's risk of having aggressive prostate cancer after an abnormal prostate specific antigen test result, and before a decision is made to perform a biopsy. The de novo pathway for approval is available to medical devices of low-to-moderate risk that do not have an approved predicate device. Per FDA guidelines, the Company expects to receive a response to this request within approximately 180 days.
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BGNE | Hot Stocks07:59 EDT BeiGene presents Phase 2 clinical results of zanubrutinib - BeiGene announced results from an ongoing pivotal Phase 2 clinical study of its investigational BTK inhibitor zanubrutinib being conducted in China in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma in an oral presentation at the 15th International Conference on Malignant Lymphoma. This single-arm, pivotal Phase 2 trial of zanubrutinib as a monotherapy in patients with R/R CLL/SLL is the basis for BeiGene's new drug application for this indication which is currently under review by the China National Medical Products Administration. The trial is being conducted in China, and enrolled 91 patients from 11 study centers, including 82 patients with CLL and nine with SLL. Patients were treated with zanubrutinib, dosed at 160 mg orally twice-daily. The primary endpoint of the trial was overall response rate assessed by independent review committee using iwCLL 2008 criteria for CLL and CT-based assessment according to the Lugano Classification 2014 for SLL. As of the December 14, 2018 data cutoff, 75 patients remained on study treatment. The median follow-up time for patients enrolled in the trial was 15.1 months. Results included: The ORR by IRC was 84.6%; the complete response rate was 3.3%; the partial response rate was 59.3% and the PR with lymphocytosis was 22.0%. ORRs per IRC were generally consistent across different subgroups; The 12-month progression-free survival was estimated at 87.2% and the median PFS had not been reached with median PFS follow-up at 12.9 months; Zanubrutinib tolerability was generally consistent with previous reports of zanubrutinib treatment in patients with various B-cell malignancies. The majority of treatment-emergent adverse events were grade 1 or 2 in severity, with the most frequently reported TEAEs being neutrophil count decrease, upper respiratory tract infection, purpura, and platelet count decreased; Grade 3 TEAEs were reported in 75.8% of patients, with the most frequently reported being neutrophil count decrease, lung infection, upper respiratory tract infection, platelet count decrease and anemia; and Three patients had TEAEs leading to death; these were determined unlikely or unrelated to zanubrutinib treatment.
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BSGM | Hot Stocks07:54 EDT BioSig Technologies issues June 2019 shareholder letter - BioSig Technologies announced that the Company has issued their June 2019 Shareholder Letter, highlighting patient cases using PURE EP System at three different medical centers, strengthening of patent portfolio and publication strategy, inclusion on the Russell 3000 Index, and other milestones moving toward commercialization. "The highlight of first five months of 2019 was, of course, the success of our first patient cases using PURE EP System at three different medical institutions," stated Mr. Kenneth Londoner, Founder, Chairman and CEO of BioSig Technologies. "BioSig attended the Heart Rhythm Society's 40th Annual Scientific Sessions and received outstanding feedback and support from the medical and scientific community. We have been working diligently towards commercialization and are excited that the PURE EP System has delivered great results during the first phase of external evaluation. Every area of our business has been solidified in the first five months of 2019 - strong balance sheet, exceptional human talent, first class clinical partners and robust intellectual property portfolio all mean that we've never been stronger as a Company. We would like to thank all our loyal shareholders - we never take your support for granted and will continue to work tirelessly on your behalf."
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KBAL | Hot Stocks07:53 EDT Kimball sets three-year targets with 4%-7% CAGR for organic revenue - In connection with its strategic imperatives, Kimball International is committed to achieving the following long-term targets: Three-year Targets: Organic revenue: 4% to 7% CAGR; Adjusted EBITDA margin: 150 to 250 basis points improvement by FY 2022; Adjusted EPS: 10% to 15% CAGR. Assumptions: US GDP growth of ~1.5% to 2.5%; Excludes acquisitions; Share repurchase to offset stock compensation dilution.
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KBAL | Hot Stocks07:50 EDT Kimball International COO Don Van Winkle to depart - As part of its organizational structure review, the Board, in consultation with Don Van Winkle, determined the positions of President, COO currently being held by Van Winkle, would be eliminated. Van Winkle is also currently serving as Interim President for the Kimball brand and will remain in his capacity as President, COO and Interim President for Kimball brand through a thoughtful transition as the Company works to fill the Kimball brand President role.
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KBAL | Hot Stocks07:48 EDT Kimball announces transformation plan for annualized pre-tax savings of $10M - Kimball International announced that its Board of Directors has approved a transformation plan in alignment with the Company's recently announced Kimball International Connect strategy. These activities are expected to optimize resources for future growth, improve efficiency and build capabilities across the organization that will establish a more cost-efficient structure to better align operations with long-term strategic goals. Highlights of the Transformation Plan: Review of overall manufacturing facility footprint to reduce excess capacity and gain efficiencies: as part of this initiative, the Company plans to exit a leased seating manufacturing facility in Martinsville, Virginia as well as evaluate its production capabilities and capacity across the organization for additional opportunities. Creation of center-led functions for finance, human resources, information technology and legal functions, which are expected to result in standardization of processes and elimination of duplication: in addition, the Company is centralizing its supply chain efforts to maximize supplier value and plans to drive more efficient practices and operations within its logistics function. Reallocation of Kimball brand selling resources to higher-growth markets; exit four product showrooms across the brands. Efforts expected to result in annualized pre-tax savings of approximately $10M when all actions are complete with pre-tax restructuring charges incurred through 2020 estimated at $8M to $9M The transformation plan will begin immediately, and the Company expects a substantial majority of the underlying activities of these actions to be completed by the end of its fiscal year 2020. In addition to the expected savings from the restructuring plan, the Company is also targeting an additional savings in fiscal year 2020 of $8M related to other cost reduction initiatives not included in the transformation plan. The total savings in fiscal year 2020 related to both the transformation plan and other cost reduction initiatives is expected to be approximately $16.M
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IIPR | Hot Stocks07:44 EDT Innovative Industrial Properties announces lease expansion with Green Peak - Innovative Industrial Properties announced yesterday evening that it entered into an amendment of the lease with Green Peak Industries, in Dimondale, Michigan, making available an additional $18.0M in funding for additional expansion of their cannabis cultivation and processing facilities at the property. The lease amendment also adjusted the base rent under the lease to take into account the additional available funding and extended the term of the lease agreement. Assuming full payment of the additional funding, IIP's total investment in the property will be $31.0M. With this additional funding, Green Peak Innovations expects to develop an additional 55,000 square feet of industrial space to augment its operations.
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VSTM | Hot Stocks07:39 EDT Verastem CEO Robert Forrester to step down - Verastem announced that Robert Forrester has decided to step down as President and CEO. Forrester has agreed to continue serving Verastem Oncology in an advisory capacity. Dan Paterson, the company's COO, has been appointed to serve as President and COO and will assume the leadership of the executive team while the Board of Directors conducts a search to identify a successor. Paterson will be supported by other members of the senior leadership team, including CFO, Rob Gagnon, whose role is being expanded to include Chief Business Officer. Paterson joined Verastem Oncology in 2011 and has served as its COO since 2014.
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EDSA | Hot Stocks07:38 EDT Edesa Biotech granted FDA approval to proceed with EB01 clinical study - Edesa Biotech has been notified by the FDA that it may proceed with its clinical investigation of EB01, a novel sPLA2 inhibitor, which Edesa is developing as a potential treatment for chronic allergic contact dermatitis. The FDA "safe to proceed" letter formally approves the company's Phase 2b clinical protocol and authorizes the company to begin its clinical investigation. Edesa expects the first patient to be enrolled in the coming quarter following the manufacturing of its drug candidate. The topical treatment being developed by Edesa is intended to inhibit the inflammatory process at its inception rather than after inflammation has occurred. In two previous clinical studies, EB01 has demonstrated "significant improvement of multiple symptoms" in contact dermatitis patients. Primary outcome measures will evaluate safety and efficacy. Secondary and exploratory measures will evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream.
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ACM | Hot Stocks07:37 EDT Starboard says Aecom separation 'a postive first step,' urges strategic review - Starboard Value, which identifies itself as one of the largest shareholders of AECOM with an ownership interest of approximately 4.0% of the company's outstanding shares, announced that it has delivered a letter to Michael Burke, AECOM's Chairman and CEO, which stated in part: "We believe that AECOM's market leading franchises are deeply undervalued and that significant opportunities exist within the control of management and the Board of Directors to unlock value. As such, we read with great interest the company's announcement this past Monday regarding its intention to spin-off the MS segment. This is potentially a positive development. However, it is just one piece of a broader set of opportunities to unlock significant value at AECOM. As detailed in this letter, the company was built through a series of acquisitions that have not been effectively integrated and operating metrics across the various segments significantly lag those of their respective peers. We believe there is a substantial opportunity to drive profitability improvements through integration and operational initiatives. In addition, we believe a more expansive and open minded strategic review of the company's assets is necessary. In this letter, our hope is to articulate to you, the Board, and other shareholders the steps we believe the company should take to create value for the benefit of all shareholders." Reference Link
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PGNX | Hot Stocks07:34 EDT Velan urges Progenics Pharmaceuticals' Board to back up recent claims - Velan Capital, one of the largest stockholders of Progenics Pharmaceuticals, issued the following statement responding to the latest letter from Progenics' Board of Directors to stockholders. "Velan calls on the Board to back up its claims by answering a few simple questions. Progenics stockholders, the true owners of the company, deserve answers and clarity. If meaningful change does not occur, we believe stockholder value will continue to be destroyed and cancer patients will continue to be neglected. We urge stockholders to 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 and stockholder alignment at Progenics - Velan urges all stockholders to vote on the GREEN proxy card today!"
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ACM | Hot Stocks07:33 EDT Starboard says Aecom separation 'a postive first step,' urges strategic review
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ABUS | Hot Stocks07:32 EDT Arbutus Biopharma receives clearance to initiate Phase 1a/1b trial of AB-729 - Arbutus Biopharma Corporation announced it has received regulatory clearance to initiate a Phase 1a/1b clinical trial of AB-729, Arbutus' subcutaneously-administered RNA interference agent. AB-729 employs a single RNAi trigger that has been shown in preclinical models to span all HBV transcripts, reduce all viral antigens, including hepatitis B surface antigen expression, and inhibit HBV replication. This RNAi agent uses Arbutus' proprietary covalently conjugated N-acetylgalactosamine hepatocyte targeting technology which is expected to allow for once-a-month dosing. As previously announced on May 3rd, a regulatory authority requested that Arbutus complete its ongoing 3- and 6-month toxicology studies before commencing the single ascending portion of the Phase 1a/1b clinical trial of AB-729. Based on further interaction with the regulatory authority, a revised protocol was submitted and Arbutus has received clearance to begin the Phase 1a/1b clinical trial.
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CIGI | Hot Stocks07:28 EDT Colliers International terminates Real Estate Services CEO for misconduct - Colliers International Group announced that Dylan Taylor has been terminated as CEO of its Real Estate Services division for misconduct including improper trading activity in Colliers securities in breach of his employment obligations. Taylor has made certain allegations which he asserts as the basis for a potential constructive dismissal claim. While management and the Board of Directors of Colliers have no reason to believe the validity of such claims, the Board has constituted a special committee to oversee an independent review of the allegations. Jay Hennick, Chairman & CEO will continue to oversee the strategy and operations of Colliers as he has in the past, with all Regional and Business Line leaders directly reporting to him. John Friedrichsen, long-time CFO, will also take on added operational responsibilities. Effective immediately, the position of CEO of Real Estate Services is eliminated.
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EFX | Hot Stocks07:17 EDT Equifax collaborates with FinTech Sandbox to help startups access data - Equifax announced a joint collaboration with FinTech Sandbox, a nonprofit that promotes innovation in the financial sector by making data and infrastructure available to well-qualified FinTech startups. Startups can now leverage various forms of consumer and commercial data from Equifax in an effort to help these new businesses develop products. In return, Sandbox startups collaborate with current and past residents by sharing learnings and advancements with respect to the FinTech ecosystem. Participating startups pay no fees and no equity is taken. In addition to data, Equifax will give analytical support to the Sandbox by allowing access to its Ignite portfolio of data and advanced analytics solutions.
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RVVTF | Hot Stocks07:15 EDT Revive to establish cannabis product derivative manufacturing facility - Revive Therapeutics announced that the company is to establish a cannabis product derivative manufacturing and development facility and it has entered into a definitive lease and purchase option agreement to a 12,000 sq. ft. facility in Mississauga, Ontario with an option to acquire 100% interest in the Mississauga Facility, as well as the option to expand into a 50,000 sq. ft. facility, at the Company's discretion, in Bowmanville, Ontario.
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GHSI | Hot Stocks07:14 EDT Guardion Health Sciences' MapcatSF receives patent form the EU - Guardion Health Sciences announced that it has received a patent from the European Union for its proprietary medical device, the MapcatSF. The MapcatSF measures the macular pigment density in the human eye, thus facilitating treatment for several ocular conditions and diseases that affect a large number of patients.
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TRVN | Hot Stocks07:12 EDT Trevena announces initiation of healthy volunteer study for oliceridine - Trevena announced that it has initiated the healthy volunteer QT interval study for oliceridine, the Company's lead investigational drug candidate for the management of moderate to severe acute pain. The Company remains on track to report topline data in the fourth quarter of 2019 and currently expects to resubmit the New Drug Application for oliceridine as early as possible in the first quarter of 2020. The primary objective of the study is to collect the additional QT interval data requested by the U.S. Food and Drug Administration for the resubmission of the NDA for oliceridine. The study will be performed in healthy volunteers at a single site as a three-period crossover design. Each subject will be randomly sequenced through all three study periods: oliceridine, placebo, and moxifloxacin as a positive control. A short, treatment-free washout occurs between each period. Electrocardiograms for all subjects will be obtained in a rigorous manner throughout the study. The Company plans to submit data on approximately 60 healthy volunteers, and among this study population, a minimum of 20 subjects will receive a cumulative dose of 27 mg, the proposed maximum daily dose of oliceridine.
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CDXS | Hot Stocks07:11 EDT Casdin Capital invests $50M in Codexis - Codexis announces that Casdin Capital, a New York City-based life science-focused investment firm and current stockholder of Codexis, has invested approximately $50M in Codexis through the purchase of shares of Codexis' common stock in a private placement.On June 20, 2019, Codexis sold 3,048,780 shares of common stock at a price per share of $16.40 in the private placement. The shares of common stock sold in this private placement have not been registered under the Securities Act of 1933, as amended, or any state securities laws, and were sold in a private placement pursuant to Regulation D of the Securities Act. The securities may not be offered or sold in the United States absent registration or pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws. Codexis has agreed to file a registration statement covering the resale of the shares of common stock acquired by Casdin within 180 days, subject to certain exceptions.
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DRI | Hot Stocks07:11 EDT Darden down 4.6% to $111.99 after FY20 profit guidance misses estimates
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SMMT | Hot Stocks07:10 EDT Summit to present on pipeline, strategy for new classes of antibiotics - Summit Therapeutics announced that it will present on its pipeline and strategy for the Company's new classes of antibiotics at the American Society for Microbiology Microbe conference. Details of the presentations are as follows: Summary: Summit has a unique three-pronged strategy in infectious diseases aimed at creating a successful, fully-integrated company. The Company focuses on new science to discover new classes of antibiotics targeted to treat specific infections. Summit's pipeline currently contains late-stage clinical and preclinical programmes for infections caused by C. difficile, N. gonorrhoeae and Enterobacteriaceae, and the Company's Discuva Platform enables the expansion of this pipeline. Summit designs creative development programmes aimed to show significant advantages over current standards of care. Finally, Summit looks to achieve commercial success by demonstrating both clinical and economic advantages of its antibiotics over currently available treatments. Title: In Vitro Activity of SMT-571 and Comparators against Clinical Isolates and Reference Strains of Neisseria gonorrhoeae.Summary: Preclinical data showed SMT-571 to be highly potent against 262 clinical strains of N. gonorrhoeae. This comprehensive panel of gonorrhoea strains, obtained from 1991 to 2018, was designed to be geographically and genetically diverse and include strains that are extensively- and multi-drug resistant, including ones resistant to ceftriaxone, the current standard of care for gonorrhoea. SMT-571, which works by a new mechanism of action targeting cell-division, was shown to be equally potent against all strains tested. It had a minimum inhibitory concentration of 0.064 to 0.125 mg/L against the strains, including those that are not susceptible to ceftriaxone. Significantly, SMT-571 did not show cross-resistance with any antibiotic currently or previously used to treat gonorrhoea infections.
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ETR | Hot Stocks07:08 EDT Entergy receives unsolicited offer from TRC Capital to purchase 1M shares - Entergy has been notified of an unsolicited mini-tender offer by TRC Capital to purchase up to 1M shares of Entergy common stock, representing approximately 0.53% of Entergy's outstanding shares as of April 30. TRC's offer price of $97.50 is 4.45% below the closing price of Entergy's common stock on June 14, the last trading day prior to the commencement of the offer. Entergy does not endorse TRC's unsolicited mini-tender offer and is in no way associated with TRC, its mini-tender offer or its mini-tender offer documentation. Entergy recommends shareholders do not tender their shares in response to TRC's mini-tender offer or, if shareholders have already tendered shares, that they withdraw their shares by providing the written notice described in the TRC mini-tender offer documents prior to the expiration of the offer, currently scheduled for July 17.
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DRI | Hot Stocks07:08 EDT Darden reports Q4 blended same-restaurant sales up 1.6% - Q4 same-restaurant sales by brand: +2.4% for Olive Garden; -3.2% for Cheddar's Scratch Kitchen; +3.3% for LongHorn Steakhouse; -1.4% for Yard House; +2.9% for The Capital Grille; -2.1% for Seasons 52; +2.0% for Eddie V's; -1.9% for Bahama Breeze.
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AXGT | Hot Stocks07:07 EDT Axovant, Yposkesi sign strategic gene therapy development partnership - Axovant Gene Therapies has signed a strategic partnership with Yposkesi, a Contract Development and Manufacturing Organization, for preferred access and reserved capacity for cGMP grade viral vector production. Under this strategic collaboration, Yposkesi will provide expertise in process development, technology transfer, manufacturing scale-up, quality control and quality assurance. The ongoing prioritized access for manufacturing resources will support Axovant's gene therapy programs as they proceed through development and commercialization, with an initial focus on the AAV-based gene therapies.
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BWEN | Hot Stocks07:05 EDT Broadwind Energy announces $30M of new tower orders - Broadwind Energy announced $30M of new tower orders to be produced at the company's facility located in Manitowoc, WI for 2019 and 2020 delivery.
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DRI | Hot Stocks07:05 EDT Darden raises quarterly dividend 17% to 88c per share - The quarterly dividend is payable on August 1 to shareholders of record on July 10.
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DRI | Hot Stocks07:04 EDT Darden sees FY20 CapEx $450M-$500M - Sees FY20: Approximately 50 gross and 44 net new restaurant openings; Total inflation of approximately 2.5%; Effective tax rate of 10% to 11%.
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IRBT | Hot Stocks07:04 EDT iRobot adds educational coding robot through acquisition of Root Robotics - iRobot has announced the addition of the Root coding robot to its product lineup through the acquisition of Root Robotics. Root is an educational robot that teaches coding and problem-solving skills to children as young as four years old. The Root coding robot is a two-wheeled, mobile platform. The acquisition of Root Robotics is not expected to contribute materially to iRobot's 2019 financial performance. Financial terms of the transaction were not disclosed.
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DRI | Hot Stocks07:01 EDT Darden reports Q4 blended same-restaurant sales up 1.6%
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DRI | Hot Stocks07:00 EDT Darden reports Q4 adjusted diluted cont ops EPS $1.76, consensus $1.72 - Reports Q4 revenue $2.23B, consensus $2.24B.
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IDXG LH | Hot Stocks06:59 EDT Interpace Diagnostics' molecular thyroid cancer tests covered by Independence - Interpace Diagnostics' (IDXG) ThyGeNEXT and ThyraMIR tests for thyroid cancer are now covered by Independence Blue Cross, providing plan benefits coverage for its members who meet established medical criteria for the tests. Independence covers nearly 2.5 million members in Philadelphia and Southeastern Pennsylvania. Interpace's testing is made available to its members by its strategic partner, LabCorp (LH), Independence's primary lab services provider, through LabCorp's Dianon Pathology specialty laboratory. Interpace Diagnostics' tests for thyroid cancer are specifically intended for patients whose initial thyroid nodules biopsy is indeterminate, without a conclusive indication of whether the nodule is malignant or benign.
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RNSDF... | Hot Stocks06:23 EDT Renault, Nissan, Waymo partner to explore driverless mobility services - Groupe Renault (RNSDF), Nissan Motor (NSANY), and Waymo (GOOG, GOOGL) have entered into an exclusive agreement for an initial period to explore all aspects of driverless mobility services for passengers and deliveries in France and Japan. The agreement is designed to bring together the strengths of each party and expand expertise by assessing market opportunities, working together to research commercial, legal and regulatory issues related to driverless transportation-as-a-service offerings in France and Japan. The Alliance of Renault-Nissan-Mitsubishi, with a global footprint and portfolio covering every segment of passenger and light commercial vehicles, is uniquely suited to join this business exploration with Waymo, a self-driving technology company building the world's most experienced driver with more than 10 million miles on public roads. The agreement marks a first step to developing long-term, profitable driverless mobility services operations. This analysis will first take place in France and Japan, home to Groupe Renault and Nissan headquarters, respectively, and may expand to other markets, excluding China, in the future. To further the exploration process, Groupe Renault and Nissan will create joint venture Alliance-focused companies in France and Japan dedicated to driverless mobility services.
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DAL | Hot Stocks06:07 EDT Delta Air Lines does not expect any technology-related flight cancellations - The company said, "Delta teams have addressed a technology issue that affected customers' ability to book, check in and board. We apologize to our customers for the inconvenience they are experiencing as we work quickly to return our operations to normal. While we expect flight delays to extend into the evening at some of our busiest domestic hubs due to this issue and weather, we do not expect any technology-related flight cancellations." Reference Link
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BEDU | Hot Stocks06:04 EDT Bright Scholar to acquire two independent boarding schools in the UK for GBP38M - Bright Scholar announced that it entered into agreements to acquire 100% equity interests in St. Michael's School and Bosworth Independent College in the United Kingdom for a total consideration of GBP38M. The company targets to close the transactions in September, subject to the satisfaction of customary closing conditions and the completion of relevant corporate and regulatory procedures. St. Michael's School is an independent school in the UK. Located in Llanelli, Wales, it offers day and boarding education from age three to 18. Established in 1923, the school currently has more than 400 students, comprised predominantly of day students as well as boarders from more than 16 countries. Bosworth Independent College is an independent boarding college in the UK. Located in Northampton, England, it provides independent boarding education to pupils from the UK and abroad from 13 to 19 years of age. Established in 1977, the school has more than 300 students, including more than 200 boarders from 39 countries.
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VRA | Hot Stocks06:03 EDT Vera Bradley to acquire majority interest in Pura Vida - Vera Bradley announced it has signed a definitive agreement to acquire a 75% interest in Creative Genius, which also operates under the name Pura Vida Bracelets. Pura Vida, based in La Jolla, California, is a rapidly growing, digitally native, and highly engaging lifestyle brand that deeply resonates with its loyal consumer following. For the fiscal year ended December 31, 2018, Pura Vida reported total revenue of $68.3M, net income of $3.8M and adjusted EBITDA of $13.7M. Vera Bradley has agreed to purchase 75% ownership of Pura Vida for a cash consideration of $75M, subject to certain purchase price adjustments, and up to $22.5M in incremental earnout consideration, subject to certain performance-based targets for calendar year 2019. The transaction is not subject to any financing conditions. Vera Bradley's existing available cash, cash equivalents, and investments will fund 100% of the purchase price. The transaction is expected to close late in Vera Bradley's second quarter of fiscal 2020 and is subject to customary closing conditions, including the receipt of required regulatory approvals. The Board of Directors of Vera Bradley approved the transaction. Vera Bradley has the right to acquire the remaining 25% stake in Pura Vida five years post-closing. Pura Vida will operate as a subsidiary of Vera Bradley from its current headquarters in La Jolla, California, and will continue to be led by Thall and Goodman.
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