Stockwinners Market Radar for October 16, 2017 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
MSBI | Hot Stocks19:02 EDT Midland States to acquire Alpine Bancorporation in roughly $181M deal - Midland States Bancorp and Alpine Bancorporation announced that they have entered into a definitive agreement under which Midland will acquire Alpine in a cash and stock transaction valued at approximately $181M. Under the terms of the definitive agreement, upon consummation of the transaction, Alpine shares, in the aggregate, will be exchanged for approximately 4.5M shares of Midland common stock and $33.3M in cash. Based upon the closing price of Midland common stock of $33.10 on October 13, 2017, this represents transaction value of approximately $181M. Midland expects the transaction to be approximately 10% accretive to earnings per share in 2019, the first full year of combined operations. Midland also expects to incur tangible book value per share dilution of approximately 6% upon the closing of the transaction, with an expected earn-back period of approximately 3.5 years using the "cross-over" method. The transaction has been approved unanimously by each company's board of directors and is expected to close during the first quarter of 2018, subject to regulatory approvals, the approval of Alpine's and Midland's shareholders, and the satisfaction of customary closing conditions.
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MYL AGN | Hot Stocks18:46 EDT Mylan CEO: 'Pleased' with court ruling on Allergan's Restasis patents - Mylan (MYL) announced that the United States District Court for the Eastern District of Texas has issued a 135-page decision finding all asserted claims of the patents relating to Restasis invalid based on obviousness. The Ccurt, recognizing that Allergan's (AGN) patent protection for Restasis ended in 2014, concluded that "Allergan is not entitled to renewed patent rights for Restasis in the form of a second wave of patent protection." The invalidated patents are United States Patent Numbers 8,629,111; 8,648,048; 8,685,930 and 9,248,191. Mylan received a covenant not to sue on the remaining two Orange Book patents, U.S. Patent Numbers 8,633,162 and 8,642,556, shortly before the trial began. The Court's decision also will be binding against the Saint Regis Mohawk Tribe, which the Court added to the lawsuit. In ultimately allowing the Tribe to join the lawsuit, the Court expressed its concerns that "sovereign immunity should not be treated as a monetizable commodity that can be purchased by private entities as part of a scheme to evade their legal responsibilities. It is not an inexhaustible asset that can be sold to any party that might find it convenient to purchase immunity from suit. Because that is in essence is what the agreement between Allergan and the Tribe does, the Court has serious reservations about whether the contract between Allergan and the Tribe should be recognized as valid, rather than being held void as being contrary to public policy." Mylan CEO Heather Bresch commented, "We couldn't be more pleased with today's federal court ruling invalidating the Restasis patents. For decades, our investments and perseverance continue to pay off as we have led the charge in challenging the unnecessary roadblocks often put up by brand pharmaceutical companies, whether it's through the regulatory pathway or around its intellectual property, which often delay access to affordable generic medicines to patients."
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NFLX | Hot Stocks18:44 EDT Netflix says seeing steady growth, great success for streaming - Says still has bias towards building over buying content. Says streaming hasn't hit inflection point yet. Says plan is to slowly increase prices with increased content. Says password sharing not a huge problem. Says broader spread in pricing reflects value in higher tiers. Says not concerned about long-term access to shows from others. Says 'extremely unlikely' to be a bidder for the Weinstein Company. Says focused on growing operating margin. Says expects 2018 U.S marketing spend to increase. Says plans to introduce about 80 original films next year. Says not interested in sports near term. Comments from Q3 earnings conference call.
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PCG | Hot Stocks18:42 EDT PG&E sees restoring service to all electric customers in CA affected by fires - PG&E said that more than 4,300 employees and mutual-aid partners continued restoring electric and gas service to customers impacted by the unprecedented wind-driven wildfires in Northern California. By late Monday night, the company anticipates restoring service to essentially all electric customers able to receive it, once approval to energize is granted by CAL FIRE. By Wednesday night, the company anticipates restoring service to all gas customers able to receive it, once safe access is granted by CAL FIRE. "To support all of our customers impacted by these terrible wildfires, we have marshalled one of the largest restoration responses in recent company history at a scale that compares with our response during the 1989 Loma Prieta earthquake," said Nick Stavropoulos, PG&E president and chief operating officer. "Surveying the devastation with our crews first hand is a sobering experience, and I am humbled by the dedication of our team and partners who are tirelessly working around the clock to restore electric and gas service. We won't rest until all our customers are restored, and we will continue to support our customers in the long term as they work to rebuild and recover from this tragedy."
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CYTR | Hot Stocks18:29 EDT CytRx granted listing extension pending results of stockholder vote - CytRx 's request for a continued listing has been granted by Nasdaq pending the results of a stockholder vote on or before October 30. The Nasdaq Hearings Panel granted the company's request for continued listing subject to the following relevant terms: on or before October 30, the company shall inform the Panel that it has received stockholder approval to implement a reverse stock split in a ratio of 1 for 6 shares. On or before November 15, the company must evidence a closing bid price of $1.00 or more for a minimum of ten prior consecutive trading days. The company intends to adjourn the scheduled Special Meeting of Stockholders planned for October 17 and the meeting will be rescheduled for October 27, at the same location, at which the company will seek stockholder approval for the 1-for-6 reverse stock split. If approved, the company plans to implement the reverse stock split shortly after the Special Meeting in order to demonstrate a closing bid price of at least $1.00 per share. The company must demonstrate a closing bid price of at least $1.00 per share for a minimum of ten consecutive trading days by no later than November 15. If the proposal does not pass and the stock does not rise to at least $1.00 per share for ten consecutive days within the period granted by the Panel, the company will then seek to commence trading on the OTC Bulletin Board.
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EADSY BDRBF | Hot Stocks18:27 EDT Airbus and Bombardier announce C Series partnership - Airbus (EADSY) and Bombardier (BDRBF) are to become partners on the C Series aircraft program. A corresponding agreement was signed. The agreement brings together Airbus' global reach and scale with Bombardier's newest, jet aircraft family. Under the agreement, Airbus will provide procurement, sales and marketing, and customer support expertise to the C Series Aircraft Limited Partnership, or CSALP, the entity that manufactures and sells the C Series. At closing, Airbus will acquire a 50.01% interest in CSALP. Bombardier and Investissement Quebec will own approximately 31% and 19% respectively.
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PG | Hot Stocks18:15 EDT Trian: P&G board election results 'too close to call' - Trian Fund Management, whose investment funds beneficially own approximately $3.5B of shares of The Procter & Gamble Company, issued a statement regarding the preliminary voting results from the 2017 Annual Meeting of Shareholders that P&G filed today with the Securities and Exchange Commission on a Current Report on Form 8-K: "IVS Associates, Inc., P&G's independent Inspector of Elections, is in the process of tabulating all the proxies and ballots submitted at the Annual Meeting in accordance with Ohio law and has yet to deliver its preliminary report let alone a final certified report of the voting results. The preliminary voting results P&G filed today, and relied on to declare victory at the Annual Meeting, are based on estimates and incomplete information reported by the Company's proxy solicitors and were calculated without full visibility into the proxies submitted by Trian to the Inspector. Trian continues to believe that the election is too close to call. We are gratified by the overwhelming support we received from P&G shareholders - including the large majority of institutional investors - and all of the nation's proxy advisory firms. Regardless of the final voting results, shareholders have sent a strong message to P&G's Board and management: a continuation of the past decade's underperformance is simply unacceptable. We look forward to reviewing the preliminary report from the independent Inspector of Elections and will take all steps to ensure accurate final voting results."
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IPXL | Hot Stocks17:55 EDT Impax jumps 6% in after-hours after WSJ says Amneal deal near - Shares of Impax are up 6.27% to $21.20 in after-hours trading after the Wall Street Journal said that Impax Laboratories and Amneal Pharmaceuticals are near a merger pact.
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AGII | Hot Stocks17:36 EDT Argo Group provides preliminary Q3 loss estimate - Argo Group announced preliminary pre-tax catastrophe loss estimates for Q3 of $85M-$110M, net of ceded reinsurance recoverables, reinstatement premiums and expected profit commissions. The net losses include approximately $35M-$45M related to Ariel Re, which was not acquired until the end of Q1. Catastrophe losses in Q3 are related primarily to Hurricanes Harvey, Irma and Maria as well as the earthquake in Mexico City. In addition, the company expects to report other non-catastrophe losses of approximately $15M, driven primarily by higher than anticipated attritional losses within the current accident year for Property business underwritten by Syndicate 1200.
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ORIG | Hot Stocks17:31 EDT Ocean Rig holder BlueMountain intends to recommend company hire advisers - Ocean Rig UDW holder BlueMountain Capital reported its stake in the company unchanged at 10.9%. The company commented in a regulatory filing: "BlueMountain intends to recommend that Ocean Rig UDW's hire advisers to review opportunities to maximize shareholder value, including changes to capital structure, utilization of significant assets, and possible strategic transactions. BlueMountain may also develop plans and/or make proposals with respect to, or with respect to potential changes in, the operations, management, the organizational documents, Board composition, ownership, capital or corporate structure, dividend policy, strategy and plans of the Issuer, utilization of significant assets, potential strategic transactions involving the Issuer or certain of the Issuer's businesses or assets. BlueMountain intends to have discussions with affiliates of Elliott Associates regarding such opportunities to enhance shareholder value and may have discussions with the persons listed above together with the Other Parties. BlueMountain may exchange information with Ocean Rig UDW and any of the foregoing persons pursuant to appropriate confidentiality or similar agreements."
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NFLX... | Hot Stocks17:31 EDT On The Fly: After Hours Movers - UP AFTER EARNINGS: Netflix (NFLX), up 1.2%. ALSO HIGHER: Immune Design (IMDZ), up 8.9% after it announced "positive" FDA feedback on its Phase 3 trial for CMB305... Spirit Airlines (SAVE), up 5.5% after it raised its total RASM guidance for the third quarter... UnitedHealth (UNH), up 0.4% after the stock was initiated with an Outperform rating at BMO Capital. DOWN AFTER EARNINGS: Badger Meter (BMI), down 10.4%... Sonic (SONC), down 2.2%. ALSO LOWER: Vical (VICL), down 4.6% after it filed to sell $23M of common stock... Abeona Therapeutics (ABEO), down 4.2% after it filed to sell common stock.
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FDC | Hot Stocks17:28 EDT First Data CAO sells 3,996 common shares - In a regulatory filing, First Data chief accounting officer Matthew Cagwin disclosed the sale of 3,996 common shares of the company at a price of $17.54 per share on October 12, 2017.
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HRS | Hot Stocks17:27 EDT Harris awarded $100M government contract modification - Harris Corp., Clifton, New Jersey, is being awarded a $100M modification for a non-competitive, single award, indefinite-delivery/indefinite-quantity contract. The contract provides suite of integrated radio and frequency countermeasure components and related services for the Technology Applications program office and CV-22 program offices. The majority of the work is performed in Clifton, NJ, with ordering periods ending on July 30, 2019. This modification increases the ceiling amount by $100M from $190M to $290M. This modification was awarded through non-competitive award in accordance with Federal Acquisition Regulation 6.302-1. U.S. Special Operations Command, Tampa, Florida, is the contracting activity.
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BA | Hot Stocks17:26 EDT Boeing awarded $240.2M government contract - The Boeing Co., Oklahoma City, Oklahoma, has been awarded a $240,195,180 fixed-price-incentive-firm contract for the Royal Saudi Air Force airborne warning and control system modernization program phase 1. This contract provides for AWACS mission computing, navigation and communications upgrades, as well as the next generation in identification, friend or foe enhancement designs. Work will be performed in Oklahoma City, Oklahoma, and is expected to be completed by Feb. 28, 2019. This contract involves foreign military sales to the Kingdom of Saudi Arabia, and is the result of a sole-source acquisition. Saudi Arabian letter of offer and acceptance case funds in the amount of $240,195,180 are being obligated at time of award. Air Force Life Cycle Management Center, Hanscom Air Force Base, Massachusetts, is the contracting activity.
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PI | Hot Stocks17:22 EDT Impinj COO sells 7,000 common shares - In a regulatory filing, Impinj president and COO Eric Broderson disclosed the sale of 7,000 common shares of the company in three tranches priced in the range of $36.1718-$37.4661 per share. The first transaction occurred on October 12, while the other two occurred on October 13.
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SAVE | Hot Stocks17:20 EDT Spirit Airlines raises Q3 total RASM view to (6.5%) from (8.5%)-(7%) - Sees Q3 ASMs up 18%. Sees Q3 adjusted CASM ex-fuel flat to down 1%. During the third quarter 2017, Spirit canceled over 1,650 flights related to Hurricanes Harvey, Irma, and Maria, according to a regulatory filing. The company estimates the unusual meteorological activity, together with the overhang from the pilot work action earlier in the year, negatively impacted third quarter revenue by approximately $40M and operating margin by approximately 450 basis points.
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RESN | Hot Stocks17:16 EDT Longboard raises stake in Resonant to 25.35% from 22.47%
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CZR | Hot Stocks17:14 EDT TPG Group reports 14.3% stake in Caesars
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IPSEY EXEL | Hot Stocks17:08 EDT Ipsen says Phase 3 Celestial trial of cabozanitinib met primary endpoint of OS - Before the market opened, Ipsen (IPSEY) and its partner Exelixis (EXEL) announced that its global phase 3 CELESTIAL trial met its primary endpoint of overall survival, with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma. The independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis. CELESTIAL is a randomized, global phase 3 trial of cabozantinib versus placebo in patients with advanced HCC who have been previously treated with sorafenib. The safety data in the study were consistent with the established profile of cabozantinib. In line with and in collaboration with our partner Exelixis, Ipsen expects to file in the first half of 2018 a variation of the initial application to the EMA and other relevant regulatory agencies and to evaluate potential next steps in the development strategy for cabozantinib outside the United States and Japan as a treatment for advanced HCC in patients who have been previously treated. Detailed results from CELESTIAL will be submitted for presentation at a future medical conference. CELESTIAL is a randomized, double-blind, placebo-controlled study of cabozantinib in patients with advanced HCC conducted at more than 100 sites globally in 19 countries. The trial was designed to enroll 760 patients with advanced HCC who previously received sorafenib and may have received up to two prior systemic cancer therapies for HCC and had adequate liver function. Enrollment of the trial was completed in September 2017, and 773 patients were ultimately randomized. Patients were randomized 2:1 to receive 60 mg of cabozantinib once daily or placebo and were stratified based on etiology of the disease, geographic region and presence of extrahepatic spread and/or macrovascular invasion. No cross-over was allowed between the study arms. Based on available clinical trial data from various published trials conducted in the second-line setting of advanced HCC, the CELESTIAL trial statistics for the primary endpoint of OS assumed a median OS of 8.2 months for the placebo arm. A total of 621 events provide the study with 90 percent power to detect a 32 percent increase in median OS at the final analysis. Two interim analyses were planned and conducted at 50 percent and 75 percent of the planned 621 events.
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TSQ | Hot Stocks17:03 EDT Townsquare Media appoints Bill Wilson and Dhruv Prasad as co-CEOs - Townsquare Media has promoted Bill Wilson and Dhruv Prasad as Co-CEOs, reporting to the board of directors. Steven Price, Townsquare's founder and current CEO, will transition to a new role of Executive Chairman of the Board. In addition, Erik Hellum has been appointed as COO, Local Media. Price founded Townsquare in May 2010 and previously served as Chairman and CEO of the company. Wilson joined Townsquare in September 2010 and most recently served as Executive Vice President and Chief Content & Digital Officer of the company.
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TRQ | Hot Stocks17:02 EDT Turquoise Hill sees FY17 Oyu Tolgoi copper production 130K-160K tonnes - Oyu Tolgoi is expected to produce 130,000 to 160,000 tonnes of copper and 100,000 to 140,000 ounces of gold in concentrates for 2017. Open-pit operations are expected to mine in Phases 4 and 6 during the year. In addition, stockpiled ore will continue to be processed during 2017.
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TRQ | Hot Stocks17:02 EDT Turquoise Hill reports Q3 Oyu Tolgoi material mined up 9% y/y - In 3Q17, material mined increased 9.0% over 2Q17 and ore treated increased 10.1% over 2Q17. During 2Q17, the concentrator underwent a scheduled maintenance shutdown. Average daily concentrator throughput for 3Q17 of 115,400 tonnes increased 8.9% over 2Q17. Copper production in 3Q17 was essentially flat compared to 2Q17 while 3Q17 gold production increased 29.2% over 2Q17 due to higher head grades from the medium-grade stockpile and Phase 4A. Higher gold grades during 3Q17 resulted in a 26.1% increase in gold sales compared to 2Q17. Jeff Tygesen, Chief Executive Officer of Turquoise Hill, said, "During the third quarter, Oyu Tolgoi set three operational records for total material mined, ore treated and average daily concentrator throughput. We are extremely proud of what the nearly all-Mongolian operations team achieved for the quarter. Copper production for the quarter was in-line with second quarter while gold production increased almost 30%."
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AHL | Hot Stocks17:00 EDT Aspen Insurance reports preliminary pre-tax hurricane impact of $310M - Aspen Insurance reported a preliminary estimate of approximately $310M in pre-tax losses, net of reinsurance and reinstatement premiums, related to Hurricanes Harvey, Irma and Maria. Approximately $110M of these losses are from Hurricane Harvey, $135M from Hurricane Irma and $65M from Hurricane Maria. In addition, Aspen estimates pre-tax losses, net of reinsurance and reinstatement premiums, of approximately $50M from several other events, the largest of which relate to weather-related losses and the Mexican earthquakes. Approximately 75% of the total estimated losses are attributed to the Reinsurance segment and approximately 25% are attributed to the Insurance segment. Aspen expects to record an underwriting loss of approximately $340M in Q3. Results for the quarter reflect the catastrophe losses described above as well as increased losses in short-tail insurance lines, primarily Property Insurance.
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GOOG | Hot Stocks17:00 EDT Google expands safeguards to unwanted software infections - Google in a posting to its blog said: "Unwanted software impacts the browsing experience of millions of web users every day. Effects of this harmful software are often quite subtle-search results are modified to redirect users to other pages or additional ads are injected in the pages that users visit. But in some cases, the changes are so severe that they can make the web unusable-people are redirected to unwanted sites full of ads, and it can be next to impossible to navigate away from these pages. Chrome already has tools to help people avoid unwanted software. For example, Safe Browsing prevents many infections from taking place by warning millions of users. But sometimes harmful software slips through. Recently, we rolled out three changes to help Chrome for Windows users recover from unwanted software infections." Reference Link
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MSFT MAR | Hot Stocks16:44 EDT Microsoft proposes election of new board members - Microsoft (MSFT) released its annual proxy statement and announced two nominations to its board of directors. The nominees are Penny Pritzker, founder and chairman of PSP Capital and former U.S. Secretary of Commerce, and Arne Sorenson, president and CEO of Marriott International (MAR). Both are accomplished leaders and will bring significant global experience to Microsoft. They will be presented for election at the company's annual shareholders meeting on Nov. 29.
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FB | Hot Stocks16:35 EDT Facebook buys positivity app TBH - TBH said on its website: "When we set out to build tbh, we wanted to create a community that made us feel happier and more confident about ourselves. We felt that people craved genuine and positive interactions in their online experiences. While the last decade of the Internet has been focused on open communication, the next milestone will be around meeting people's emotional needs. It looks like this hunch might be true: over the last few weeks, over 5 million people have downloaded tbh and sent over a billion messages. More importantly, we've been inspired by the countless stories where tbh helped people recover from depression and form better relationships with friends.Today we're announcing that we're joining Facebook to continue our mission. When we met with Facebook, we realized that we shared many of the same core values about connecting people through positive interactions. Most of all, we were compelled by the ways they could help us realize tbh's vision and bring it to more people. Going forward, your experience on tbh won't change and we'll continue to build the features you love-now with plenty more resources." Reference Link
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SBOW | Hot Stocks16:33 EDT SilverBow: Oro Grande well had 940 MMcfe cumulative production over 90 days - SilverBow Resources announced that the company's Oro Grande NMC 1-H well had cumulative production over 940M cubic feet of natural gas equivalent after ninety producing days. The well is currently producing approximately 11M cubic feet of natural gas equivalent per day with nearly 6,000 pounds per square inch of flowing tubing pressure under the company's detailed pressure management program. The well had a lateral length of 7,500 feet and utilized the company's largest completion design of roughly 3,400 pounds of proppant per lateral foot. "Our use of modern seismic, geo-steering, and completion design are yielding a marked increase in our well performance as compared to the historical development in this area," said Sean Woolverton, Chief Executive Office of SilverBow Resources. "The NMC 1-H is an important milestone and proof-of-concept well for the Company as we transfer our learnings from Fasken to other areas of the gas and condensate windows of the Eagle Ford. Furthermore, our strong results from Oro Grande have prompted us to move the rig back to the area to drill our second well sooner than what was originally scheduled. We are currently completing the NMC 2-H with plans to drill a third well in the area in early 2018."
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JBLU... | Hot Stocks16:32 EDT Astronics unit awarded awarded EmPOWER in-seat passenger power contracts - Astronics announced that its wholly owned subsidiary, Astronics Advanced Electronic Systems, was recently selected by six major North American airlines to install industry-leading EmPOWER in-seat power systems on up to 1,400 narrow-body and regional jet aircraft. Astronics AES will equip the airplanes with 110VAC and high output USB power for every passenger from "nose to tail," including the cabin crew stations. Line-fit and retrofit installations will occur from early 2018 through 2023. Publicly traded companies in the space include American Airlines (AAL), Delta Air Lines (DAL), JetBlue (JBLU), Southwest (LUV) and United Continental (UAL).
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IHC | Hot Stocks16:24 EDT Independence Holding Co. raises annual dividend 42% to 17c per share - Independence Holding Company announced that the Board of Directors has voted to increase the cash dividend by 42% to 17c per share annually, effective with the next semi-annual dividend payable in January 2018. This is the third recent increase. In January 2017, the semi-annual dividend paid to the stockholders reflected a 33% increase from 9c to 12c annually. In July 2015, the semi-annual dividend paid to the stockholders reflected a 29% increase from 7c to 9c annually.
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BMY | Hot Stocks16:21 EDT Bristol-Myers says FDA accepts Opdivo sBLA, grants priority review - Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration has accepted for priority review its supplemental Biologics License Application for Opdivo to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection. The FDA also previously granted Breakthrough Therapy Designation for this application, which is the seventh indication for which Opdivo has received this designation. "Priority review of our sBLA and the granting of breakthrough designation are positive steps forward in our goal to address the high unmet need that exists among patients with resected advanced melanoma, many of whom experience disease recurrence," said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. The application is based on data from the ongoing Phase 3 CheckMate -238 study, which evaluated Opdivo in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma. In the study, Opdivo 3 mg/kg met the primary endpoint by significantly decreasing the risk of disease recurrence compared to Yervoy 10 mg/kg, an FDA-approved treatment for stage III adjuvant melanoma. The results of the study were recently presented at the European Society for Medical Oncology 2017 Congress and published simultaneously in the New England Journal of Medicine.
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NFLX | Hot Stocks16:18 EDT Netflix says will spend $7B-$8B on content in 2018 - Netflix said in its quarterly letter to investors: "Investors often ask us about continued access to content from diversified media companies. While we have multi-year deals in place preventing any sudden reduction in content licensing, the long-term trends are clear. Our future largely lies in exclusive original content that drives both excitement around Netflix and enormous viewing satisfaction for our global membership and its wide variety of tastes...With $17 billion in content commitments over the next several years and a growing library of owned content ($2.5 billion net book value at the end of the quarter), we remain quite comfortable with our ability to please our members around the world. We'll spend $7-8 billion on content (on a P&L basis) in 2018."
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IMDZ | Hot Stocks16:18 EDT Immune Design announces positive FDA feedback on Phase III Trial for CMB305 - Immune Design announced that based on productive discussions with the FDA, it plans to initiate a pivotal Phase 3 trial to support a Biologics License Application for CMB305, a novel cancer vaccine, in patients with synovial sarcoma. The randomized Phase 3 trial will evaluate CMB305 monotherapy vs. placebo in patients with NY-ESO-1+ locally advanced unresectable or metastatic synovial sarcoma, a sub type of soft tissue sarcoma, who have no evidence of progression after first-line chemotherapy. Immune Design intends to start the study in mid-2018 and enroll 248 patients aged twelve and older. Patients will be randomized 1:1 to receive either CMB305 monotherapy or placebo. The trial will have progression free survival followed by overall survival as co-primary endpoints. If the PFS endpoint is successful, the FDA offered that it may support full approval of CMB305. Depending on the rate of events, final PFS analysis may occur as early as 24 months from the first patient dosed.
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SGMS... | Hot Stocks16:16 EDT Scientific Games signs agreement with Apigee - Scientific Games (SGMS) announced that it has signed an agreement with Apigee, a subsidiary of Google (GOOG, GOOGL), to utilize its full lifecycle application programming interface management platform, as part of the Company's portfolio of casino management technology solutions for the gaming industry. This agreement allows Scientific Games to deploy Apigee API management software in its suite of casino and slot management systems solutions and will enable Scientific Games to design, secure, deploy, monitor, and scale APIs. Apigee's industry-leading solution will make integration with third-party applications easier, more secure, more reliable, and more operationally efficient.
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NFLX | Hot Stocks16:15 EDT Netflix backs FY17 FCF view of ($2.0B)-($2.5B) - Netflix said: "Free cash flow in Q3 totaled -$465M vs. -$506M last year and -$608M in Q2'17. There is no change to our expectation for FCF of -$2.0B to -$2.5B for the full year 2017. Negative FCF, despite growing operating income, is due to growth of our content spend, original content in particular, where we pay for the titles before consumers enjoy the content, and the asset is amortized by estimated viewing over time. We anticipate financing our capital needs in the debt market as our after-tax cost of debt is lower than our cost of equity."
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NFLX | Hot Stocks16:13 EDT Netflix sees Q4 streaming net additions of 6.3M members - Sees Q4 U.S. streaming net additions of 1.25M and international net additions of 5.05M.
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NFLX | Hot Stocks16:13 EDT Netflix reports Q3 streaming net additions of 5.3M members - Reports Q3 U.S. streaming net additions of 850,000 and international net additions of 4.45M.
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ANIK | Hot Stocks16:09 EDT Anika Therapeutics announces regulatory approval for Monovisc in Australia - Anika Therapeutic announced that regulatory authorities in Australia granted approval to Monovisc, Anika's single injection viscosupplement for the treatment of pain associated with osteoarthritis of all synovial joints, including the hip and knee. Monovisc is commercially available in over twenty countries, including the United States, Canada, and various European countries. Monovisc also recently received approval in the Asia-Pacific countries of India and Taiwan. Anika intends to further expand Monovisc into additional international markets in 2018. The global expansion of Monovisc is an important international orthobiologics revenue driver for Anika, and Australia and New Zealand represent a large and growing market opportunity. Anika has a multi-year, exclusive distribution agreement with Surgical Specialties to market Monovisc in Australia and New Zealand.
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SAIC | Hot Stocks16:07 EDT SAIC COO sells 18,772 common shares - In a regulatory filing, SAIC COO Nazzic Keene disclosed the sale of 18,772 common shares of the company in two tranches at a price range of $68.8195-$69.31 per share.
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GOGL | Hot Stocks16:05 EDT Golden Ocean acquires two capesize vessels for $43M per vessel - Golden Ocean Group announced that it has agreed to acquire two modern Capesize vessels from affiliates of Hemen Holding Limited at a purchase price of $43.0M per vessel. As settlement of the purchase price for the vessels, the company will enter into a non-amortizing seller's credit loan with an affiliate of Hemen for 50% of the purchase price, which bears interest at LIBOR + 3.00% per annum and matures three years after delivery of the vessels. The remaining part of the purchase price will be settled on delivery of the vessels with an estimated $9.0M of cash and an estimated $34.0M million of newly-issued common shares of the company at a per-share price equal to the offer price in an expected equity offering. Following completion of the acquisition and expected equity offering, Hemen, together with certain of its affiliates, will maintain its current ownership percentage of approximately 34.2% of the company's issued and outstanding common shares.
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DEST | Hot Stocks16:05 EDT Destination Maternity continues to expect $10M - $11M in yearly savings - Destination Maternity provided an operational update following constructive engagements with company stockholders over the last several weeks. The investments we have made in our ecommerce platform this year have generated significant positive momentum, as evidenced by the channel's 30.2% rise in comparable sales for the second quarter and an over 50% rise so far in the third quarter. "Building from this strength, we will continue to maximize the connectivity between our digital and brick and mortar channels, creating a seamless, category-focused retail experience with a high level of personal service for our customer. The next steps in this evolution include opening up ship-from-store fulfillment from all Company stores by the beginning of next month, rolling out our pick-up-from store by the end of this calendar year, as well as additional short term initiatives including reserve online/pickup in store, and online appointments for in-store visits." Weinstein continued, "In addition to implementing operational initiatives, management has worked closely with the Board to transform Destination into a more nimble, more efficient and more effective Company by streamlining the organizational structure and business processes, and focusing resources to more directly benefit the customer. Apart from the operational benefits which should manifest themselves in better operating results, these changes are expected to deliver $10M to $11M in run-rate savings beginning in fiscal year 2018, with one-time costs of approximately $3 million that will mostly be incurred in fiscal year 2017. As we look to the future, we will continue to evaluate effective means of streamlining processes, such as the ongoing evaluation of our real estate portfolio, as part of our broader efforts to meaningfully improve financial results and generate shareholder value."Barry Erdos, Non-Executive Chairman of the Board, commented, "The Board is encouraged by what Allen and the management team have accomplished in such a brief time. We continue to search for a permanent CEO, and are gratified to have Allen leading Destination during the interim period, giving us the time needed to conduct a thorough search."
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CZR | Hot Stocks16:04 EDT Senator Investment reports 6.18% passive stake in Caesars
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AMGN | Hot Stocks16:02 EDT Amgen, Boston Children's Hospital in research pact to identify pain targets - Amgen and Boston Children's Hospital announced that they have entered into a neuroscience research collaboration aimed at identifying novel pain targets based on human genetic analyses. The one-year collaboration will focus on patients with genetic anomalies of pain sensitivity. Amgen will leverage its industry-leading expertise in genetic target identification and validation and will have access to Boston Children's Hospital's Division of Pain Medicine to identify patients with abnormal pain conditions. Amgen and Boston Children's Hospital will collaborate to validate the genetic findings as potential pain targets.
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CIT | Hot Stocks16:01 EDT CIT Group declares quarterly cash dividend of 16c per share - The common stock dividend is payable on Nov. 24 to common shareholders of record as of Nov. 10.
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MGI | Hot Stocks15:49 EDT Sandell Asset Management reports 6.6% passive stake in MoneyGram
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SPR | Hot Stocks15:33 EDT Spirit AeroSystems reaches licensing agreement with NDT Solutions - Spirit AeroSystems announced it has reached a licensing agreement with NDT Solutions to commercialize Spirit's innovative inspection device for ultrasonic inspection of complex, integrated composite structures. The new technology supports inspection of composite structures from the inside out instead of the typical surface-only inspection.
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AWK | Hot Stocks14:50 EDT American Water unit files rate case with commission for additional revenue - On April 28, Pennsylvania-American Water Company, PAWC, a wholly owned subsidiary of American Water Works Company filed a general rate case with the Pennsylvania Public Utility Commission requesting $108M in additional annualized water and wastewater revenues. On October 16, PAWC and the other parties to the proceeding entered into a proposed settlement agreement to provide PAWC with additional annualized water and wastewater revenues of $62M. To take effect, the proposed settlement agreement must be approved by the PaPUC after a public hearing and initial decision by the administrative law judges assigned to the case by the PaPUC. The parties to the proceeding have agreed to use their best efforts to obtain PaPUC approval of the settlement agreement on or before December 7, and the implementation of the new water and wastewater rates on January 1.
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WILC | Hot Stocks14:47 EDT G. Willi-Food announces appointment of Amir Kaplan as CFO - G. Willi-Food announced that Amir Kaplan has been appointed as chief financial officer effective immediately. Kaplan served since July 2011 as the CFO of RSL Electronics, an Israeli public company whose shares are traded on the Tel Aviv Stock Exchange. The company also announced that Yitschak Barabi, the former interim chief financial officer, has been appointed as controller and deputy chief financial officer.
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COF | Hot Stocks14:42 EDT Capital One trust reports September default date 2.09% vs. 2.14% last month - Reports September 30-plus day delinquency rate 2.06% vs. 1.97% last month.
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FSC | Hot Stocks14:29 EDT Springhouse Capital reports 5.7% passive stake in Fifth Street Finance
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C | Hot Stocks14:06 EDT Citi reports September credit loss 2.44% vs. 2.41% last month - Reports September 30-plus day delinquency rate 1.5% vs. 1.43% last month.
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GRUB BJRI | Hot Stocks14:03 EDT Grubhub, BJ's Restaurants announced online ordering partnership - Grubhub (GRUB) announced a new partnership with BJ's Restaurants (BJRI) to provide turnkey delivery and corporate catering for 100 BJ's Restaurant & Brewhouse locations. Guests can now order their favorite BJ's dishes easily through Grubhub's online and mobile platforms. Delivery and corporate catering from Grubhub is now available at 100 BJ's Restaurant & Brewhouse locations in California, Colorado, Florida, Kentucky, Maryland, Nevada, New Mexico, North Carolina, Ohio, Oregon, Pennsylvania, Arizona, Texas, Virginia and the District of Columbia.
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AGN | Hot Stocks13:48 EDT Allergan says 'disappointed' by adverse ruling on Restasis patents, will appeal - Allergan acknowledged that the U.S. District Court for the Eastern District of Texas has issued an adverse trial decision finding that the four asserted patents covering Restasis 0.05% are invalid. The company will appeal the Court's ruling, it announced, adding that none of the proposed generic versions of Restasis have received approval to date and none of these products would be able to launch in the market. "We are disappointed by the Federal District Court's decision on the Restasis patents. We are carefully reviewing the decision and are considering all options. Allergan remains committed to vigorously defending the intellectual property of our products, which allows us to continue to invest in developing and bringing forward new medicines for millions of patients," said Robert Bailey, Chief Legal Officer, Allergan.
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AGN | Hot Stocks13:46 EDT Allergan says will appeal U.S. District Court ruling on Restasis patents
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SHLD SWK | Hot Stocks13:43 EDT Sears drops after top shareholder Berkowitz steps down from board - Shares of Sears Holdings (SHLD) dropped in afternoon trading after the company said Bruce Berkowitz is leaving its board, effective October 31. BERKOWITZ LEAVES BOARD: Sears announced this morning that Bruce Berkowitz will step down from its board of directors, effective October 31. Berkowitz, who joined the board of Sears in February 2016, is the chief investment manager of Fairholme Capital Management and is the president and a director of investment firm Fairholme Funds. Fairholme Capital Management is the second largest shareholder of Sears shares behind Sears chairman and CEO Eddie Lampert. "I wish the company and its associates all the best as Sears Holdings continues to execute on its strategic priorities," Berkowitz said in a statement. He did not say why he is stepping down. Lampert said that Berkowitz's "leadership, guidance and counsel as a board member have been invaluable to our company." WHAT'S NOTABLE: According to regulatory filings, Berkowitz took his first stake in Sears in August 2005 through the Fairholme Fund. According to a June report in The Wall Street Journal, Fairholme has lost 89% of its assets since its peak in 2011 and was staking a comeback partly on his fund's growing bet on Sears. Berkowitz previously supported Lampert's plan to spin off real estate assets and the company's Craftsman brand, which sold to Stanley Black & Decker (SWK) earlier this year. PRICE ACTION: Sears is down 11.3% to $6.01 in afternoon trading. Shares are down about 35% year-to-date.
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RTN | Hot Stocks13:32 EDT Raytheon opens new engineering facility in Albuquerque - Raytheon Company has opened a new facility in the Sandia Science and Technology Park, expanding its operations to develop and produce range monitoring and telemetry systems for the U.S. and its allies. The expansion will bring 60 new high-tech manufacturing jobs to the state over the next six years. The company employs more than 350 workers in science, engineering, advanced manufacturing and management jobs at its facilities in Albuquerque and Dine, located on the Navajo Nation. The new 72,000-square-foot building is the third facility for Raytheon in Albuquerque. The State of New Mexico and City of Albuquerque helped pay for site improvements through Local Economic Development Act, or LEDA, funds.
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AGN | Hot Stocks13:23 EDT Allergan drops after judge voices 'serious concerns' about patent 'tactic' - Shares of Allergan (AGN) have dropped sharply after a federal circuit judge said the court has "serious concerns about the legitimacy of the tactic" Allergan and the St. Regis Mohawk Tribe employed previously as the drugmaker sought to protect its patents for Restasis in a novel maneuver. The judge said he would allow the tribe to be joined as co-plaintiff in the Restasis case only to ensure his ruling invalidating the patents isn't later challenged on the grounds that not all of the proper parties were joined, according to Bloomberg. Following news of his ruling, shares of Allergan are down nearly 5% to $195.80.
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ELY | Hot Stocks13:21 EDT Sancarin S.L. reports 5.15% passive stake in Callaway Golf
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LW | Hot Stocks13:01 EDT Lamb Weston opens expanded operations in Richland, WA - Lamb Weston Holdings announced the completed expansion of its operations in Richland, WA. The $200M investment announced in 2016 adds a new processing line to the existing facility, increasing the company's processing capacity for making frozen french fries. The expansion adds approximately 150 jobs to the local economy. The 290,000 square foot, state-of-the-art expansion adds a new processing line to the company's existing facility, increasing production capacity by approximately 300 million pounds annually. More than 600 employees at both the existing facility and expansion will make 600 million pounds of frozen french fries annually.
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BRN | Hot Stocks12:53 EDT Gate City Capital reports 5.41% passive stake in Barnwell Industries
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NSM | Hot Stocks12:48 EDT Nationstar drops 5%, or $1.03, to $18.59
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ADBE | Hot Stocks12:47 EDT Adobe releases security update for Flash Player addressing vulnerability - Adobe on its website said it has released a security update for Adobe Flash Player for Windows, Macintosh, Linux and Chrome OS. This update addresses a critical type confusion vulnerability that could lead to code execution. Adobe is aware of a report that an exploit for CVE-2017-11292 exists in the wild, and is being used in limited, targeted attacks against users running Windows. Reference Link
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DDAIF | Hot Stocks12:42 EDT Daimler confirms plans for three legally independent entities - Daimler AG aims to further focus and strengthen the Group's corporate structure through the creation of legally independent entities. In addition to the existing legally independent division Financial Services, the divisions Mercedes-Benz Cars & Vans as well as Daimler Trucks & Buses may be transferred into two legally independent entities to take greater entrepreneurial responsibility. This project intends to strengthen the future viability of the business units and better utilize the potential for growth and earnings in the various markets. Safeguarding Daimler's future is based on three pillars: protecting and increasing the company's success, pushing forward with shaping the future for the employees, and ensuring the long-term commitment of investors. Based on the positive results of a feasibility study, the Board of Management decided, subject to the approval of the Supervisory Board, to continue with the project and in this context to take preparatory measures. Daimler will invest a three-digit million euro amount for these first steps. With the possible implementation of a new structure under the roof and lead of Daimler AG, there would be three independent entities: Mercedes-Benz Cars & Vans and Daimler Trucks & Buses as two new entities, and the existing legally independent Daimler Financial Services AG. The three entities would continue to have their registered offices in Germany. Daimler AG does not plan to divest any of its divisions. In connection with the balance of interests, Daimler plans a contribution of EUR3B from liquid funds to the German pension fund of Daimler AG in the fourth quarter 2017, subject to the approval of the Supervisory Board. This is to increase to funded status of the pension obligations. Furthermore, the company is reinforcing its employees' pension commitments and intends to contribute to the strengthening Daimler's A-Rating.Until now, neither the Board of Management nor the Supervisory Board of Daimler AG has made a final decision on implementing the new structure for the Daimler Group. Both boards will come to a final resolution after the ongoing assessments and negotiations have been completed, such as tax-related issues or a comprehensive due diligence. Should the Board of Management and Supervisory Board decide to finally implement the new Group structure, those measures would require the approval of a shareholders' meeting of Daimler AG. Such a motion could be voted on at the earliest at a shareholders' meeting in the year 2019.
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MOH... | Hot Stocks12:22 EDT Trump calls subsidies to insurance companies a 'disgrace' - President Trump, while speaking from the White House, spoke of how well the stocks of health insurance companies have done since the Affordable Care Act was enacted into law. Trump called the subsidies a "disgrace" and a "payoff." Publicly traded companies in the health insurance space include Aetna (AET), Anthem (ANTM), Centene (CNC), Cigna (CI), Health Net (HNT), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH) and WellCare (WCG).
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AXP | Hot Stocks12:09 EDT American Express reports September net write-off rate 1.6% vs. 1.8% last month - Reports September 30 days past due loans 1.1% vs. 1.1% last month.
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CMI | Hot Stocks12:01 EDT Cummins to acquire assets of Brammo, Inc; financial terms not disclosed - Cummins announced that it is acquiring the assets of Brammo, Inc., which designs and develops battery packs for mobile and stationary applications. Operations from this acquisition will report under Cummins' recently formed Electrification Business led by Julie Furber, Executive Director of Electrification at Cummins, and will continue to be based in Talent, Oregon. This acquisition adds to Cummins' portfolio of solutions and provides an entry point into new markets. In August, Cummins revealed a fully electric heavy duty demonstration Urban Hauler Tractor. This acquisition is subject to customary closing conditions and is expected to close by the end of this calendar year.
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EBAY | Hot Stocks11:32 EDT eBay announces launch of eBay Authenticate authentication service - eBay announced the launch of eBay Authenticate, a white glove authentication service designed to help the marketplace's hundreds of millions active buyers shop with confidence for luxury handbags. eBay sellers can now utilize the service to list luxury handbags and wallets valued at $500+ and receive 80% of the final selling price when selling luxury handbags from 12 high-end brands, including Balenciaga, Burberry, Celine, Chanel, Christian Dior, Fendi, Goyard, Gucci, Hermes, Louis Vuitton, Prada, and Valentino. For a limited time, the service will accept luxury handbags valued at $250+ and sellers will receive 90% of the final sale price. For eBay buyers, they can shop more confidently for luxury handbags knowing that items marked with an "Authenticity Verified" label are backed by a 200 percent Money Back Guarantee. Reference Link
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FB | Hot Stocks11:20 EDT Facebook testing resume/CV feature for job hunters, TNW's Matt Navarra tweets - Matt Navarra, director of social media for The Next Web, tweets that "Facebook is testing a resume/CV feature for job hunters." Reference Link
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NGHC | Hot Stocks11:15 EDT National General sees $55M-$65M of losses in Q3 from hurricanes - National General Holdings announced that it expects its Q3 results to include $25M-$30M in losses from Hurricane Irma and $5M in losses from Hurricane Maria, both net of quota share reinsurance recoverables. Total net hurricane losses for the quarter, including the previously disclosed losses from Hurricane Harvey of $25M-$30M, will impact the third quarter by $55M-$65M. National General CEO Barry Karfunkel commented: "The successive hurricane events this quarter have caused an unfortunate amount of damage domestically. We are working with our talented claims staff to pay claims and assist our insureds in rebuilding what they have lost."
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BB... | Hot Stocks10:35 EDT BlackBerry in focus as patent licensing director exits - Shares of BlackBerry (BB) are in focus after a senior executive is said to have left the company, marking the second high-level departure in the last three weeks. EXECUTIVE DEPARTURES: Victor Schubert, a key attorney executing BlackBerry's patent licensing strategy told Reuters in a LinkedIn message that he is no longer with the company. Schubert joined BlackBerry in March 2015. Schubert's exit follows the departure of Mark Kokes, the head of BlackBerry's patent monetization strategy who left earlier this month to join health technology firm NantWorks, which houses startups focused on global health information and next-generation pharmaceuticals. According to Reuters, Kokes' departure followed a May announcement that Ron Louks, a former Blackberry president for devices and emerging solutions, was moving to NantHealth (NH), a publicly-traded unit of NantWorks, to serve as COO. WHAT'S NOTABLE: BlackBerry Chief Executive Officer John Chen views the company's patent portfolio as a key element in its turnaround strategy as it looks to focus more on its software and the enterprise business. Chen has previously said BlackBerry has "one of the youngest patent portfolios in the entire industry, so monetization of our patents is an important aspect of our turnaround." SYMBOL CHANGE: Separately, BlackBerry's ticker symbol changed to "BB" from "BBRY" today as it moved to the New York Stock Exchange from Nasdaq. CEO Chen told CNBC this morning that the NYSE is a stronger marketing platform for the company at this time versus Nasdaq. PRICE ACTION: BlackBerry shares are flat at $11.58.
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CRI... | Hot Stocks10:28 EDT Carter's, Hanesbrands lower after Cowen uncovers potential Amazon risk - Shares of Carter's (CRI) and Hanesbrands (HBI) are lower after Cowen analyst John Kernan said his conversations over the weekend with supply chain contacts suggest Amazon (AMZN) may develop clothes for intimates, baby and basics. The analyst, who detailed his thoughts in a research note dated Sunday, views possible competition from Amazon as a risk to Hanesbrands and Carter's. Both stocks are down over 1% in early trading.
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CRI... | Hot Stocks10:25 EDT Carter's, Hanesbrands lower are Cowen uncovers potential Amazon risk - Shares of Carter's (CRI) and Hanesbrands (HBI) are lower after Cowen analyst John Kernan said his conversations over the weekend with supply chain contacts suggest Amazon (AMZN) may develop clothes for intimates, baby and basics. The analyst views possible competition from Amazon as a risk to Hanesbrands and Carter's. Both stocks are down over 1% in early trading.
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OMC... | Hot Stocks10:23 EDT Morgan Stanley says sell Omnicom as 'new normal' not good for ad agencies - Shares of Omnicom (OMC) are sliding after Morgan Stanley analyst Benjamin Swinburne downgraded the stock to Underweight, the firm's equivalent to a sell rating, as he contends that "lower for longer is the new normal" for advertising agencies. The analyst also cut his price target on peer Interpublic Group (IPG), while nothing he disagrees with the consensus view that organic growth will return for the industry in 2018. SELL OMNICOM: In a research note to investors this morning, Morgan Stanley's Swinburne downgraded Omnicom to Underweight from Equal Weight and lowered his price target on the shares to $72 from $86. The analyst pointed out that he disagrees with the consensus view that organic growth will return for the industry in 2018, and thinks "lower for longer" is the "new normal." Swinburne argued that ad agencies are part of the supply chain to major brands pressured by shifting consumer behavior driven by Amazon (AMZN) and other tech platforms. Year-over-year organic growth is already negative in the U.S. market, and seven years into an economic expansion the analyst believes consensus estimates are too high. In addition to accelerating top line growth, consensus also bakes in continued margin expansion, which Swinburn believes will become more challenging to achieve. The analyst also told investors that he sees growing risk from major consulting firms, particularly Accenture (ACN) but also IBM (IBM), who are attempting to capture marketing budget that might have otherwise gone to agencies. Swinburne also cut his price target on peer Interpublic Group to $22 from $24, but kept an Equal Weight rating on that stock to account for its strategic optionality. Interpublic Group's relatively smaller size makes it likely the only "digestible" holding company, he contended. PRICE ACTION: In morning trading, shares of Omnicom dropped over 2% to $73.39, while Interpublic has slipped about 1.6% to $20.50.
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CRI HBI | Hot Stocks10:22 EDT Carter's, Hanesbrands lower are Cowen uncovers potential Amazon risk - Shares of Carter's (CRI) and Hanesbrands (HBI) are lower after Cowen analyst John Kernan said his conversations over the weekend with supply chain contacts suggest Amazon (AMZN) may develop clothes for intimates, baby and basics. The views possible competition from Amazon as risk to Hanesbrands and Carter's. Both stocks are down over 1% in early trading.
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TEUM | Hot Stocks10:20 EDT Pareteum Corp trading resumes
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EXEL... | Hot Stocks10:19 EDT Exelixis surges after Cabometyx granted priority review, meets endpoint in trial - Shares of Exelixis (EXEL) jumped in early trading after the biopharmaceutical company said it received priority review from the U.S. Food and Drug Administration for a treatment for advanced renal cell carcinoma. Separately, the company said a global Phase 3 trial met its primary endpoint of overall survival. FDA PRIORITY REVIEW: Exelixis announced this morning that it has won priority review status from the FDA for its supplemental new drug application for a treatment for advanced renal cell carcinoma. The biotech company said its sNDA is based on results of data from Cabosun, a phase 2 trial of Cabometyx geared towards patients with previously untreated advanced renal cell carcinoma, or RCC. The Phase 2 trial was conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis' collaboration with the National Cancer Institute's Cancer Therapy Evaluation Program. Cabometyx was approved by the FDA in April 2016 for the treatment of patients with advanced RCC who have received prior anti-angioegenic therapy. According to Exelixis, the American Cancer Society's 2017 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S. Exelixis said today that the FDA assigned a Prescription Drug User Fee Act, or PDUFA, action date of February 15, 2018. CABOMETYX MEETS ENDPOINT: Separately, Exelixis announced this morning that Cabometyx met the primary goal of overall survival in a global Phase 3 Celestial trial with partner Ipsen (IPSEY). The companies said that Cabometyx showed statistically significant and "clinically meaningful improvement" in overall survival compared to placebo in patients with advanced hepatocellular carcinoma. Based on these results, Exelixis said it plans to submit a supplemental new drug application to the FDA in the first quarter of 2018. "We are excited that these positive results from the phase 3 Celestial trial bring us one step closer to the potential of offering previously treated patients with this aggressive form of advanced liver cancer a much-needed new treatment option," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer at Exelixis. ANALYST COMMENTARY: In a note to clients this morning, SunTrust analyst Peter Lawson raised his price target to $35 from $33 and reiterated his Buy rating on Exelixis, saying the Celestial trial results positions Cabometyx "well" against Bayer's (BAYRY) regorafenib, its main competitor. According to the analyst, the results validate the expansion of cabozantinib beyond kidney cancer, potentially positioning Exelixis as an attractive M&A target. PRICE ACTION: In early trading, Exelixis is up 31% to $32.49. Shares are up over 100% year-to-date.
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BAC | Hot Stocks10:09 EDT Bank of America reports September default rate 2.81% vs. 2.80% last month - Reports September 30-plus day delinquency rate 1.56% vs. 1.55% last month.
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WLTW | Hot Stocks10:06 EDT Willis Towers Watson to sell multiple insurance programs to AmWINS - AmWINS Group has reached a definitive agreement to acquire 15 insurance programs from Willis Towers Watson. The acquisition is expected to be completed on October 31. Terms of the transaction were not disclosed.
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CI | Hot Stocks10:02 EDT Cigna-HealthSpring details MA, MAPD plans for 2018 - Cigna-HealthSpring's Medicare Advantage plans and Medicare Advantage Plans with Prescription Drug Coverage for the Medicare Annual Election Period emphasize stable premiums and physician engagement along with a number of additional benefits, such as fitness memberships and dental, vision and hearing coverage. Open enrollment began Oct. 15 and continues through Dec. 7. Nearly half of Cigna-HealthSpring's plans for 2018 are available at $0 monthly premium. Of the remaining plans, many premiums remained flat or decreased from 2017. In more than 70 percent of plans, customers pay no copay when they visit their primary care physician. Cigna-HealthSpring also promotes wellness through a fitness program, which is available in most plans. And more than one-third of the company's plans provide qualifying customers with some transportation to their doctor or pharmacy. Cigna-HealthSpring also offers dental, vision and hearing coverage in most of its plans and that includes glasses and hearing aids. Cigna-HealthSpring's Medicare Advantage plans are offered in Alabama, Arkansas, Arizona, Delaware, Florida, Georgia, Illinois, Kansas, Missouri, Maryland, Pennsylvania, Mississippi, North Carolina, South Carolina, Tennessee, Texas and the District of Columbia. Cigna-HealthSpring also continues to offer two standalone prescription drug plans in all states: the Secure Plan and the Secure Extra Plan.
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WFC | Hot Stocks09:54 EDT Wells Fargo broker-dealers ordered to pay $3.4M in restitution by FINRA - The Financial Industry Regulatory Authority announced that it has ordered Wells Fargo Clearing Services, LLC and Wells Fargo Advisors Financial Network, LLC to pay more than $3.4M in restitution to affected customers for unsuitable recommendations of volatility-linked exchange-traded products and related supervisory failures. FINRA found that between July 1, 2010, and May 1, 2012, certain Wells Fargo registered representatives recommended volatility-linked ETPs without fully understanding their risks and features. FINRA found that Wells Fargo failed to implement a reasonable system to supervise solicited sales of these products during the relevant time period. However, FINRA found that Wells Fargo took remedial action to correct its supervisory deficiencies in May 2012, prior to detection by FINRA and around the time that the firm was fined for similar violations relating to sales of leveraged and inverse ETPs. In addition, Wells Fargo provided substantial assistance to FINRA's investigation by, among other things, engaging a consulting firm to determine the appropriate restitution to be provided to affected customers. In settling with FINRA, Wells Fargo neither admitted nor denied the charges, but consented to the entry of FINRA's findings.
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TNDM | Hot Stocks09:40 EDT Sabby Management takes passive stake in Tandem Diabetes - Sabby Management disclosed a new 5.63% stake in Tandem Diabetes, which represents 570,000 shares. The filing is for a passive stake and does not allow for activism.
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TEUM | Hot Stocks09:36 EDT Pareteum Corp trading halted, news pending
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MTZ | Hot Stocks09:30 EDT MasTec announces $1.5B large project pipeline construction award - MasTec announced that it has been awarded a large project pipeline construction award with an expected contract value of over $1.5B. Construction activity for this U.S. based award is expected to commence in 2018. Jose Mas, MasTec's CEO, commented, "We are pleased to announce this large project award and continue to see significant multi-year opportunities for large pipeline construction project activity in the U.S. We remain highly confident in our previously indicated expectation that our year-end 2017 Oil & Gas segment backlog will approach or exceed our year end 2016 levels. We will provide further information regarding activity in the U.S. large project pipeline market, which includes recent Oil & Gas awards aggregating nearly $2 billion, during our third quarter 2017 earnings conference call in early November."
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CLNY | Hot Stocks09:28 EDT Weinstein Co. in talks with Colony Capital on potential sale
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MDT | Hot Stocks09:28 EDT MCMS enters strategic partnership with American Well - Medtronic announced its Medtronic Care Management Services, or MCMS, business and American Well entered into a first-of-its-kind strategic partnership to enable a more complete telehealth solution focused on the unique needs of the complex, chronic, co-morbid patient population. Under the terms of the agreement, the businesses will work together to enable patient access to American Well's telemedicine services on MCMS' video-enabled platforms, and to allow bi-directional data flow between the two parties. The telehealth solution will provide information from MCMS' remote patient monitoring to clinicians performing consultations using American Well's telemedicine capabilities, and enable information from these telemedicine visits to be included in MCMS' clinical management software. The partnership is designed to provide greater patient access to their care team, while improving clinician access to the critical information needed when making care decisions -especially as they evaluate opportunities for early intervention.
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TTPH | Hot Stocks09:26 EDT Tetraphase appoints Kamalam Unninayar as CFO - Tetraphase Pharmaceuticals (TTPH) announced the appointment of Kamalam Unninayar as CFO. Most recently, Kam spent over 11 years overseeing finance organizations at Thermo Fisher Scientific (TMO).
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CLNY CLNS | Hot Stocks09:26 EDT The Weinstein Company announces investment from Colony Capital - The Weinstein Company announced that it has entered into a preliminary agreement with Colony Capital to provide an immediate capital infusion into the company. In addition, the company has entered a negotiating period with Colony Capital for a potential sale of all or a significant portion of the company's assets. TWC board member, Tarak Ben Ammar, said, "On behalf of the board, we are pleased to announce this agreement and potential strategic partnership with Colony Capital. We believe that Colony's investment and sponsorship will help stabilize the Company's current operations, as well as provide comfort to our critical distribution, production and talent partners around the world. Colony's successful experience and track record in media and entertainment will be invaluable to the company as we move forward."
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RT... | Hot Stocks09:23 EDT On The Fly: Pre-market Movers - HIGHER: Ruby Tuesday (RT), up 19.1% after announcing it will be acquired by NRD Capital for $2.40 per share... Aramark (ARMK), up 4% after announcing it will acquire Avendra for $1.35B and AmeriPride Services for $1B... Shire (SHPG), up 2.3% after its new formulation of Oncaspar received a positive opinion from the Committee for Medicinal Products for Human Use... Apple (AAPL), up just under 1% after being upgraded to Overweight from Sector Weight at KeyBanc... Health Insurance Innovations (HIIQ), up 11.9% after reporting preliminary third quarter results... Concurrent (CCUR), up 16.4% after it agrees to sell its Content Delivery & Storage Business to Vecima Networks for $29M. LOWER: Charles Schwab (SCHW), down 1.6% after reporting quarterly results... Concordia (CXRX), down 4.4% after announcing it will defer payment of approximately $26M of interest due on its $735M unsecured notes... ITUS (ITUS), down 11% after filing a $24M mixed securities shelf.
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VHC AAPL | Hot Stocks09:13 EDT VirnetX announces final judgement of $439.7M in patent suit with Apple - VirnetX (VHC) announced that on September 29 the United States District Court for the Eastern District of Texas, Tyler Division, entered a Final Judgement and issued its Memorandum Opinion and Order regarding post-trial motions resulting from the prior $302.4M jury verdict for VirnetX in the ongoing patent infringement action between the company and Apple (AAPL). The Court granted all VirnetX's motions; motion for willful infringement and enhanced the royalty rate during the willfulness period by 50%, from $1.20 to $1.80, awarding VirnetX enhanced damages in the amount of $41,271,364.80 against Apple thereby, granting VirnetX a total sum of $343,699,314.80 in pre-interest damages. The Court also awarded costs, certain attorneys' fees, and prejudgment interest to VirnetX, and directed the parties to meet and confer regarding these amounts. On October 13, having met and conferred and having reached agreements on all amounts, parties jointly filed a motion asking the Court to grant VirnetX an additional sum in the amount of $96,028,103.58 in agreed Bill of Costs, Attorneys' Fees, and Prejudgment Interest. The Final Judgement is only subject to appeal stemming from new issues unresolved in the Apple I case, remanded back from the United States Court of Appeals for the Federal Circuit. The total Final Judgement amount including Jury Verdict, Willful Infringement, Interest, Costs and Attorney Fees is $439,727,418. Kendall Larsen, VirnetX CEO and President, said, "This Final Judgement amount is large because sales of Apple's infringing products are large. The cost of our security technology in infringing devices has been apportioned and is less than a quarter of one percent of the device's cost. We believe this established per device rate for security is very reasonable and will greatly assist us with our domestic and global licensing efforts."
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JWN | Hot Stocks09:10 EDT Nordstrom suspends active exploration of going private transaction - Nordstrom announced that members of the Nordstrom family - company co-presidents Blake Nordstrom, Peter Nordstrom, and Erik Nordstrom, president of stores James Nordstrom, chairman emeritus Bruce Nordstrom, and Anne Gittinger - have notified the Special Committee of the Board of Directors of Nordstrom that the group has suspended active exploration, for the balance of the year, of the possibility of proposing a transaction to take the company private. The Group informed the Special Committee that it intends to continue its efforts to explore the possibility of making a going private proposal after the conclusion of the holiday season. The Special Committee, which is committed to protecting the interests of the Company and all its shareholders, is prepared to thoroughly evaluate such a proposal from the Group at that time, if one is made. In the meantime, the Company and its employees will remain focused on running the business and delivering the best shopping experience for customers.
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JWN | Hot Stocks09:10 EDT Nordstrom suspends exploration of going private amid financing difficulty - Bruce Nordstrom disclosed in a regulatory filing that on October 13, representatives advised Nordstrom's Special Committee that, in light of the difficulty of obtaining debt financing in the current retail environment prior to the conclusion of the approaching holiday season, the group has suspended active exploration, for the balance of the year, of the possibility of proposing a going private transaction. Nordstrom added, "The management members of the Group believe it is important to maintain their focus on the execution of the Issuer's business plan for the year-end period. The Group's representatives also advised the Special Committee that the Group intends to continue its efforts to explore the possibility of making a proposal for a Going Private Transaction after the conclusion of the holiday season. No assurance can be given that a proposal for a Going Private Transaction will be made after such time." Shares of Nordstrom are down 5%, or $2.12 to $40.53 in premarket trading.
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JWN | Hot Stocks09:09 EDT Nordstrom to remain focused on running the business in the meantime
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JWN | Hot Stocks09:09 EDT Nordstrom says family to continue efforts after holiday season
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HMHC | Hot Stocks09:08 EDT Houghton Mifflin announces leadership changes - Houghton Mifflin Harcourt announced changes to its executive team, with new incorporations and promotion of internal leaders. Reporting directly to CEO Lynch, the following executives will serve leading roles: Jim O'Neill, EVP and General Manager, Core Curriculum, joining most recently from Achieve3000; Matthew Mugo Fields, EVP and General Manager, Supplemental Curriculum; Rose Else-Mitchell, EVP and Chief Learning Officer, who joined HMH in 2015, will focus on the efficacy of HMH's programs and services to drive student outcomes; Amy Dunkin, SVP and Chief Marketing Officer, will oversee product marketing, field marketing, market research, pricing, an in-house creative agency, communications, and digital and demand generation teams; Alejandro Reyes, SVP and Chief People Officer, joins HMH from Laureate Education, where he served as the Chief Talent and Organization Development Officer; Trish Torizzo, SVP and Chief Information Officer, will focus on leveraging the company's enterprise software solutions to streamline all internal operations and improve the customer experience; Vicki Boyd, EVP and General Manager, Heinemann, HMH's professional development publishing arm.
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JWN | Hot Stocks09:04 EDT Nordstrom suspends exploration of going private for remainder of year
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JWN | Hot Stocks09:04 EDT Nordstrom suspends active exploration of going private
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FB SNAP | Hot Stocks09:04 EDT United American Corp issues cease and desist notices to Facebook, Instagram - United American Corp announced that on October 12, it issued cease and desist notices to Facebook (FB) and Instagram related to their respective geolocation-based image overlays which it asserts infringes on UnitedCorp's iFramed technology. The iFramed Patent and Patent Application which was allowed by the US Patent Trademark Office on October 3, is directed to the implementation of a dedicated mobile content sharing application that can acquire and share new user images or videos, but also gives users the ability to select between distinct locally sourced external content items based on their location to be integrated within their own content before sharing. A Canadian patent for iFramed was issued on June 14, 2016 and the technology is patent pending in several international jurisdictions including Japan, Australia, China, India and throughout Europe. Both Facebook "Frames" and Instagram "Geostickers" provide users with image overlays which are based on the user's geolocations. Users can then post their content to their respective social media accounts. "Frames" and "Geostickers" features are a direct infringement of iFramed intellectual property. The action follows similar cease and desist notices issued to Snap Inc. (SNAP) on October 3 regarding Snap's use of geo-location based filters which it markets as "Geofilters" and to certain clients of Snap which use its Geofilters.
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SPA | Hot Stocks09:03 EDT Sparton, Ultra Electronics USSI JV awarded $12.9M in foreign sales contracts - Sparton Corporation and Ultra Electronics USSI, a subsidiary of Ultra Electronics Holdings, announce the award of subcontracts valued at $12.9M from their ERAPSCO/SonobuoyTech Systems joint venture. ERAPSCO/SonobuoyTech Systems will provide manufacturing subcontracts in the amount of $5.7M to Ultra Electronics USSI and $7.2M to Sparton De Leon Springs. Production will take place at Ultra Electronics USSI's Columbia City, IN facility and Sparton's De Leon Springs, FL facility. ERAPSCO/SonobuoyTech Systems were awarded multiple foreign contracts for the manufacture of Passive and Active sonobuoys in support of multiple underwater missions for detection, classification, and localization of adversary submarines during peacetime and combat operations.
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AJG | Hot Stocks09:03 EDT Arthur J. Gallagher acquires Reynolds & Rodar Insurance Group - Arthur J. Gallagher acquired Santa Fe, New Mexico-based Reynolds & Rodar Insurance Group. Terms of the transaction were not disclosed. Reynolds & Rodar is the oldest independent agency in New Mexico and provides commercial property/casualty and employee benefits coverages and services, and high-net-worth personal lines coverages, to clients in New Mexico and throughout the southwestern U.S.
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C FIS | Hot Stocks09:02 EDT Citi, FIS enable real-time payments for corporate treasury customers - FIS (FIS) and Citi Treasury and Trade Solutions (C) announced that they are collaborating to enable real-time payments and cash management for their corporate treasury customers. Using the CitiConnect application programming interfaces, FIS has connected its Trax corporate payments factory to the suite of Citi Treasury and Trade Solutions -- enabling seamless integration with Citi's core treasury management functionality, including payment initiation, transaction status inquiry, and balance inquiry.
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HRS | Hot Stocks09:01 EDT Harris awarded $133M U.S. Navy, Australian F/A-18 electronic warfare contract - Harris Corporation has received a $133M contract to supply electronic jammers to protect U.S. Navy and Australian F/A-18 Hornet and Super Hornet aircraft against electronic threats. The contract was awarded during the first quarter of Harris' fiscal 2018. Under the contract, Harris will manufacture and deliver ALQ-214(V)4/5 Integrated Defensive Electronic Countermeasures jammers for the F/A-18C/D/E/F variants. The ALQ-214(V)4/5 is the key onboard electronic warfare jamming system for the IDECM program and protects the aircraft from sophisticated electronic threats, including modern integrated air defense systems. Deliveries to the U.S. Navy and to Australia through the U.S. government's Foreign Military Sales program are expected to be complete by May 2020.
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EMR | Hot Stocks09:01 EDT Emerson agrees to acquire Paradigm for $510M - Emerson has agreed to acquire Paradigm, a provider of software solutions for the oil and gas industry, for a purchase price of $510M, reflecting a multiple of 13 times expected 2017 EBITDA. Paradigm, joined with Emerson's existing Roxar software business, creates an end-to-end Exploration & Production software portfolio with offerings spanning seismic processing and interpretation to production modeling. Paradigm's technology offerings will enable Emerson to better help oil and gas operators increase efficiency, reduce costs and improve return on investment. Paradigm is headquartered in Houston and has more than 500 employees globally. The acquisition is expected to close within the next 60 days, subject to various regulatory approvals.
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SPX | Hot Stocks09:01 EDT Trump highlights stock market gains since election day - President Donald Trump just tweeted, "Since Election Day on November 8, the Stock Market is up more than 25%, unemployment is at a 17 year low & companies are coming back to U.S...The U.S. has gained more than 5.2 trillion dollars in Stock Market Value since Election Day! Also, record business enthusiasm."
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HNP | Hot Stocks08:58 EDT Huaneng Power's power generation in China in Q1-Q3 up 24.4% y-o-y - Huaneng Power announced its power generation for the first three quarters of 2017. The company's total power generation by power plants within China on consolidated basis amounted to 107.592 billion kWh, representing an increase of 24.36% over the same period last year. Total electricity sold by the company amounted to 101.092 billion kWh, representing an increase of 23.79% over the same period last year. For the first three quarters of 2017, the company's total power generation by the power plants within China on consolidated basis amounted to 294.271 billion kWh, representing an increase of 26.52% over the same period last year. Total electricity sold by the company amounted to 277.212 billion kWh, representing an increase of 26.16% over the same period last year. The substantial increase in the company's power generation was mainly attributable to the following factors: the acquisition of the power assets in areas like Heilongjiang, Jilin and Shandong by the company contributed to the substantial increase in power generation of the company; and the thermal power generation in central China, eastern China and Guangdong increased year on year.
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SCHW | Hot Stocks08:48 EDT Charles Schwab: Preliminary Tier 1 Leverage Ratio at quarter-end was 7.7% - CFO Peter Crawford commented, "We've achieved yet another quarter of record financial performance, helped by strong client growth and an improved economic environment. Schwab posted its ninth consecutive quarter of record revenues for the period ending in September. Net interest revenue grew 28% to $1.1B as a result of higher short-term rates and growing client cash balances. Following the Federal Reserve's June rate hike, our net interest margin reached 200 basis points for the third quarter - our highest level since the second quarter of 2010. Asset management and administration fees were up 8% year-over-year to a record $861M, largely attributable to growing balances in advised solutions, mutual funds, and ETFs. These increases in our largest sources of revenue more than offset a 21% decline in Trading revenue due to lower trade pricing. Overall, we produced net revenues of $2.2B, a 13% increase... The FHLB advances, the third quarter money fund transfers, and higher client cash levels all helped our consolidated balance sheet reach $230.7 billion as of September 30th; our preliminary Tier 1 Leverage Ratio at quarter-end was 7.7%. We delivered a 15% return on equity for the third quarter, reflecting our ability to combine effective capital management with a relentless drive for profitable growth to help build stockholder value."
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SHPG | Hot Stocks08:43 EDT Shire reports new formulation of Oncaspar receives positive CHMP opinion - Shire announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion recommending the marketing authorization for lyophilized Oncaspar, as a component of antineoplastic combination therapy in acute lymphoblastic leukemia in pediatric patients from birth to 18 years, and in adult patients. The CHMP's positive opinion will be submitted to the European Commission, which is responsible for granting marketing authorizations for medicines in the EU.
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CPST | Hot Stocks08:42 EDT Capstone Turbine enters partnership with EIC in Pittsburgh, PA - Capstone Turbine announced today that it has partnered with the Energy Innovation Center, or EIC, in Pittsburgh, Pennsylvania to retrofit its building with clean and green Capstone microturbines.
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RWLK | Hot Stocks08:41 EDT ReWalk Robotics' soft exosuit technology begins next testing phase - ReWalk Robotics' soft exosuit technology currently in development has entered the next phase of testing and verification in collaboration with researchers at Harvard University's Wyss Institute for Biologically Inspired Engineering. This phase of testing includes evaluating the ReWalk exosuit system that is based on Wyss Institute exosuit technology with individuals who have had a stroke, in preparation for upcoming clinical trials to be run at clinical sites in 2018. This technology is designed for use by stroke survivors with lower limb disability.
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BKD | Hot Stocks08:39 EDT Brookdale Senior Living COO Labeed Diab resigning - Brookdale Senior Living COO Labeed S. Diab provided notice to the company that he will resign from his position effective October 28 to pursue another opportunity. As previously announced, Brookdale's Board and management team are working with legal and financial advisors in a process of exploring options and alternatives to create and enhance stockholder value. That process remains ongoing.
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TDW | Hot Stocks08:38 EDT Tidewater CEO Jeffrey Platt to retire, Larry Rigdon named interim CEO - Tidewater announced that Jeffrey Platt has elected to retire effective October 15 from his roles as CEO, President, and a director of Tidewater. The Board of Directors has appointed Larry Rigdon as its interim CEO and President, effective immediately. The Board has formed a search committee to identify a permanent successor CEO and President. Rigdon, who was appointed to serve on the Board following the financial restructuring, is a seasoned executive in the industry. Rigdon has prior experience as an executive at Tidewater, retiring as Executive Vice President in 2002 after joining the company in 1992 with the merger with Zapata Gulf Marine Corporation. In light of Rigdon's interim dual role as CEO and President, Rigdon has stepped down from the audit committee and the Board has appointed Steven Newman as his replacement.
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RT | Hot Stocks08:38 EDT Ruby Tuesday to be acquired by NRD Capital for $2.40 per share - Ruby Tuesday announced an agreement to be acquired by a fund managed by NRD Capital, an Atlanta-based private equity firm that specializes in franchised and multi-location business investments.Under the terms of the agreement, NRD will acquire all of Ruby Tuesday's common stock for $2.40 per share in cash and will assume or retire all debt obligations for a total enterprise value of approximately $335M, excluding transaction expense. The purchase price represents a premium of approximately 37% over Ruby Tuesday's closing share price on March 13, 2017, the day before the Company announced its intention to explore strategic alternatives, and a premium of approximately 21% over Ruby Tuesday's closing share price on October 13, 2017."The Board of Directors and our advisors have thoroughly evaluated all options available to the Company and are confident that this agreement will provide the most promising opportunity to realize the highest value for our stockholders while providing the best path forward for the Ruby Tuesday brand, its employees, franchisees, and loyal customers," said Stephen Sadove, Non-executive Chairman of Ruby Tuesday. "NRD Capital has a distinguished track record of achieving and maintaining profitable growth for restaurant concepts and will be an excellent partner to lead Ruby Tuesday going forward." The transaction has been unanimously approved by Ruby Tuesday's Board of Directors and NRD and is subject to shareholder approval and other customary closing conditions. The acquisition is expected to be completed during the first calendar quarter of 2018. UBS Investment Bank is serving as financial advisor to Ruby Tuesday and provided a fairness opinion to the Ruby Tuesday Board of Directors.
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RT | Hot Stocks08:37 EDT Ruby Tuesday to be acquired by NRD Capital for $2.40 per share -
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BKD | Hot Stocks08:37 EDT Brookdale Senior Living provides update of hurricane and wildfire impact - Brookdale Senior Living provided an update on the impact of Hurricanes Harvey and Irma and the Northern California wildfires. All but one of the communities in areas impacted by these hurricanes have returned to operation, though seven communities will experience some continuing disruption as storm damage is remediated. As a result of the hurricanes, the company expects a negative impact to Adjusted EBITDA of $12M-$13M for 2017. Adjusted EBITDA for Q3 is expected to reflect a negative impact of approximately $9M, , approximately one-third of which is expected to result from lost revenue in the company's home health business in Florida and the remainder of which is expected to result from rent credits and increased operating costs relating to the hurricane response. Adjusted EBITDA for Q4 is expected to reflect a negative impact of $3M-$4M, split between lower ancillary services revenue and increased operating costs. The company also estimates that it will incur an additional $13M-$14M of capitalized costs for physical plant remediation, $5M-$6M of which the company expects to incur during Q4 and the remainder of which it expects to incur in 2018. In addition, as a result of Hurricane Irma, Florida issued an emergency order requiring nursing homes and assisted living facilities to obtain generators and the fuel necessary to sustain operations and maintain comfortable temperatures in the event of a power outage. The financial impact of complying with that order is not yet known. The company continues to monitor the wildfires in California. Approximately 20 of the company's California communities are being affected by the wildfires. The company evacuated the residents of six communities, two of which have returned to full operation, and others are hosting residents who were evacuated. So far, none of the communities have suffered major damage from the wildfires.
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AZRE | Hot Stocks08:36 EDT Azure Power wins 250 MW solar power project - Azure Power announced that it has won a 250 megawatt solar project in an auction conducted by NTPC Vidyut Vyapar Nigam. NVVN is a wholly owned subsidiary of the Government of India's largest power utility, National Thermal Power Corporation, which received a AAA debt rating from CRISIL, a Standard & Poor's Company. Azure Power will provide power to NVVN at a tariff of INR 3.14 per kWh for 25 years and the solar PV project can be located anywhere in India, which will be outside a solar park..With this win, Azure Power will now be the largest provider of solar power to AAA-rated NTPC and its subsidiaries.
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CGI | Hot Stocks08:36 EDT Celadon Group names Thom Albrecht as Chief Financial and Strategy Officer - Celadon Group announced the appointment of Thom Albrecht as Executive Vice President - Chief Financial and Strategy Officer, effective October 16. Albrecht was unanimously appointed by the company's Board of Directors. Albrecht has been a transportation industry financial analyst since 1988 and currently serves as President of Sword & Sea Transport. Albrecht succeeds Bobby Peavler as CFO. Peavler will continue to be a resource for the company.
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JPM... | Hot Stocks08:35 EDT JPMorgan deploys blockchain with RBC, ANZ Banking - J.P. Morgan (JPM) with two global partners, Royal Bank of Canada (RY) and Australia and New Zealand Banking Group (ANZBY) announced the launch of the Interbank Information Network (IIN). The new initiative will use blockchain technology to minimize friction in the global payments process. IIN will allow payments to reach beneficiaries faster with fewer steps and better security. Processing global payments is very complex. Multiple layers of communication occur amongst payment participants to verify and process transactions. By leveraging blockchain technology, IIN will significantly reduce the number of participants currently needed to respond to compliance and other data-related inquiries that delay payments. Royal Bank of Canada and Australia and New Zealand Banking Group Limited are the first two banks to join IIN, representing significant cross-border payment volumes. Other correspondent banks are expected to join in the coming months. IIN is powered by Quorum, a permissioned-variant of the Ethereum blockchain, developed by J.P. Morgan. Quorum's focus on privacy enables secure data sharing via IIN. J.P. Morgan's Treasury Services business processes approximately $5T in payments every day for clients in more than 100 countries. The business has been aggressively investing in technology to improve end-to-end client experience. In particular, emerging technologies such as blockchain, machine learning and robotics are being deployed by the business to improve platforms and develop innovative products and solutions.
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ABEO | Hot Stocks08:34 EDT Abeona announces collaborative agreement between nine Sanfilippo foundations - Abeona Therapeutics announced a collaborative agreement between nine Sanfilippo foundations to provide approximately $13.85M of grants to Abeona in installments for the advancement of the Company's clinical stage gene therapies for Sanfilippo Syndrome Type A and Sanfilippo Syndrome Type B.
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FRGI | Hot Stocks08:34 EDT Fiesta Restaurant appoints Charles Locke as Taco Cabana President - Fiesta Restaurant Group announced that Charles "Chuck" Locke has joined the company as Taco Cabana President. Fiesta SVP and COO Danny Meisenheimer will also assume the additional role of Pollo Tropical President. These appointments are effective as of October 16. Locke and Meisenheimer will report to Fiesta President and CEO Richard Stockinger.
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GIB | Hot Stocks08:33 EDT CGI Group awarded passport production contract renewal with Dept. of State - CGI announced that is has been awarded a base plus four years and a potential ceiling of $900M+ contract renewal with the U.S. Department of State, Bureau of Consular Affairs for onsite management, administration and processing support at three passport centers and 24 passport agencies nationwide. Under the Passport Production Support Services contract, CGI will continue to provide passport applications processing, passport book processing, customer service support, document and quality control, and mail-out services for the Bureau's Passport Services Directorate.
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CE | Hot Stocks08:32 EDT Celanese announces global capacity expansions to support growth - Celanese announced plans to expand the capacity of its global compounding assets and certain product-specific manufacturing production sites to support the significant growth in its engineered materials business. "As the global demand for specialty materials increases in key industries such as medical, automotive, consumer goods and electronics, Celanese is partnering with our customers to deliver the innovative materials found in products that consumers around the world use every day," said Scott Richardson, SVP, Celanese engineered materials business. "These planned capacity expansions at selected Celanese facilities - along with our recent acquisitions - will enable us to continue to support a growing and diverse customer base and respond to the increasing need for compounded specialty materials, long-fiber thermoplastics and ultra-high molecular weight polyethylene." In the Asia region, Celanese will add two production lines at its Nanjing, China, facility and one production line at its recently acquired Suzhou, China, facility. In the Americas region, Celanese will add two production lines at its Florence, Kentucky, facility, as well as expand compounding production capacity at its Bishop, Texas, facility. In the European region, Celanese will add one new production line at its recently acquired Forli, Italy, facility. Celanese expects these new production lines and expansions will add approximately 50-60kt per year in compounding capacity. The company also expects through the debottlenecking of existing global production lines to see an additional 10-15kt per year capacity of compounded material production capability. In the Americas region, Celanese is in the process of adding one new Celstran long-fiber thermoplastics production line at its Winona, Minnesota, facility as well as debottlenecking existing production lines at this facility. The company expects through this expansion and the debottlenecking of existing global LFT production lines to see an additional 9kt per year of capacity. In the Asia region, Celanese is in the planning stages of one new GUR ultra-high molecular weight polyethylene production line at its Nanjing, China, facility. The company expects this new production line to add approximately 15kt per year of new GUR UHMW-PE product capacity.
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NUVA | Hot Stocks08:32 EDT NuVasive granted expanded FDA 510(k) clearance for TLX interobody system - NuVasive announced an expanded FDA 510(k) clearance of the company's TLX interbody system, used in spinal fusion surgery. New clearance introduces an expandable 20 degree cage and broader indications for use, including use with allogeneic bone graft and use in additional levels of the spine. Prior to the expanded 510(k) clearance, TLX interbodies were available in 15 degree lordotic options and were only indicated for use with allograft. Use of the TLX interbody system as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis was also cleared. .
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HXL | Hot Stocks08:32 EDT Hexcel, Vestas expand composite material supply agreement for wind blades - Hexcel announced that it has expanded its existing supply agreement with Vestas Wind Systems A/S to provide composite materials for new generation wind blades. Under the terms of the multi-year agreement, Hexcel will supply Vestas with advanced prepreg manufactured at Hexcel plants in Neumarkt, Windsor, Colorado, and Tianjin.
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SHLD | Hot Stocks08:32 EDT Sears says Bruce Berkowitz to step down from board of directors - Sears Holdings announced that Bruce Berkowitz has decided to step down from the company's board of directors, effective October 31. Berkowitz joined the board of Sears Holdings in February 2016.
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FLKS | Hot Stocks08:31 EDT Flex Pharma initiates CMT Phase 2 trial with FLX-787 in U.S. - Flex Pharma announced that, under its open investigational new drug application, the company has initiated a Phase 2 randomized, controlled, double-blinded, parallel design trial in the US, referred to as the COMMIT trial. The COMMIT trial will evaluate FLX-787, the company's co-activator of TRPA1 and TRPV1, in patients with Charcot-Marie-Tooth, who suffer from painful, debilitating cramps. The company expects to report topline results from this study in the middle of 2018. The company initiated a Phase 2 clinical trial in ALS earlier this quarter. The FDA has granted FLX-787 Fast Track designation for the treatment of severe muscle cramps associated with ALS. The COMMIT trial is a Phase 2 clinical trial designed to evaluate FLX-787 in patients with Charcot-Marie-Tooth who suffer from cramps. This randomized, controlled, double-blinded, parallel design trial in the U.S. will include a run-in period to establish a baseline in cramp frequency. Patients will then be randomized to 30 mg of FLX-787 administered three times a day, or control, for 28 days. Patients will be evaluated for changes in cramp frequency as the primary endpoint, with a number of secondary endpoints.
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CCUR | Hot Stocks08:30 EDT Concurrent trading resumes
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MDWD | Hot Stocks08:29 EDT MediWound announces distribution agreement Taiwan with Holy Stone Healthcare - MediWound announced an agreement with Holy Stone Healthcare for the distribution of NexoBrid in Taiwan for the treatment of severe burns. Commercialization of NexoBrid in Taiwan will commence after receipt of local regulatory approvals, which will be filed with the local regulatory authorities by Holy Stone Healthcare and is expected to be granted within two years or possibly longer.
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DFS | Hot Stocks08:24 EDT Discover reports September net charge-off rate 2.8% vs. 2.8% last month - Reports September 30-plus day delinquencies 2.1% vs. 2.1% last month.
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JRVR | Hot Stocks08:18 EDT James River Group sees hurricane losses of about $10M - James River Group announced that its initial pretax loss estimate from Hurricanes Harvey, Irma and Maria is expected to be approximately $10M, net of reinsurance and reinstatement premiums. "Our expected loss of $10M in the face of industry losses that are likely to exceed $100B is an affirmation of our low volatility model. This loss will affect our earnings for the quarter and the year. However, we continue to anticipate earning a 12% or better return on tangible equity for the full year," said J. Adam Abram, Chairman and CEO of James River.
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XON | Hot Stocks08:16 EDT Intrexon announces milestone in development of armyworm pest solution - Intrexon announced the achievement of a key milestone in the development of its solution for control of the agricultural pest fall armyworm in collaboration with an agricultural company. Intrexon Crop Protection's targeted, biologically-based approach utilizing Oxitec's self-limiting insect technology aims to control this major agricultural pest and prevent widespread crop losses. With this achievement, Intrexon received a milestone payment and its collaboration on the self-limiting fall armyworm continues its advancement in development.
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ERJ | Hot Stocks08:16 EDT Embraer announces order for six A-29 Super Tucano from undisclosed customer - Embraer announced a firm order for six A-29 Super Tucano light attack and advanced training aircraft from an undisclosed customer. The aircraft can be used for tactical and advanced training as well as light attack and ISR missions. Deliveries will be concluded in 2018.
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CCUR | Hot Stocks08:15 EDT Concurrent agrees to sell Content Delivery & Storage Business to Vecima Networks - Concurrent Computer has entered into a definitive agreement to sell all of the assets of its Content Delivery & Storage Business to Vecima Networks for a base purchase price of $29M, subject to adjustment for normalized net working capital. Headquartered in Victoria, British Columbia, Vecima is a leading designer and manufacturer of innovative network technology solutions. The proposed transaction, which has been approved by the board of both companies, is subject to various terms and conditions including stockholder approval from Concurrent.
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CELG | Hot Stocks08:14 EDT Celgene to present Phase 2 studies of ozanimod in Crohn's, ulerative colitis - Celgene Corporation announced that phase 2 data of investigational compound ozanimod in Crohn's disease and ulcerative colitis will be presented at the World Congress of Gastroenterology at ACG2017 in Orlando. The studies include new data from the STEPSTONE study in patients with moderately to severely active Crohn's disease and long-term data from the open-label extension of the TOUCHSTONE study in patients with moderately to severely active ulcerative colitis. Ozanimod is an investigational, selective sphingosine 1-phosphate 1 and 5 receptor modulator. The STEPSTONE data presented at WCOG at ACG2017 will include the first 12-week data from the phase 2, open-label study. STEPSTONE evaluated endoscopic improvement and clinical outcomes following treatment with ozanimod 1.0 mg daily for 12 weeks in 69 patients with a mean age of 37.7 years with moderately to severely active CD. Patients with available data at baseline and week 12 were included in the analyses of the simple endoscopic score for Crohn's disease matched intestinal segments and the analysis of Crohn's disease activity index. SES-CD score reductions from baseline of at least 50% and 25% were seen in 27% and 43% of patients, respectively. Patients who had shorter disease duration had a greater endoscopic response: 50% and 25% reductions were seen in 36% and 50% of patients, respectively. Patients who had lower baseline endoscopic disease activity also had a greater endoscopic response: 50% and 25% reductions were seen in 30% and 49% of patients, respectively. Reductions in mean CDAI scores from baseline were seen at week 4, with further reductions through week 12. At week 12, a CDAI response was observed in 66% of patients, and CDAI remission was observed in 46% of patients. The mean CDAI reduction at week 12 was 130 points. The most frequently reported adverse events and serious AEs in patients appeared to be related to underlying CD. The most common AEs were CD flare, abdominal pain, nausea, lymphopenia, arthralgia, vomiting, increased gamma-glutamyl transpeptidase, urinary tract infection, paresthesia, anal abscess and increased alanine aminotransferase. The most common SAEs in two or more patients were CD flare, fistulizing disease, intestinal obstruction and abdominal abscess. A separate presentation at WCOG at ACG2017 will report 92-week data on subjects who participated in the TOUCHSTONE open-label extension. TOUCHSTONE evaluated the efficacy and safety of 0.5 mg and 1.0 mg doses of ozanimod compared with placebo after eight weeks of treatment in 197 patients with moderate to severe UC. The primary endpoint was the proportion of patients in remission at week 8. Patients who achieved a clinical response at week 8 continued with their original treatment through week 32 in a maintenance phase. Previously reported results from TOUCHSTONE demonstrated statistically significant improvements in both the primary and secondary endpoints in patients who received 1.0 mg dose of ozanimod versus placebo. TOUCHSTONE participants in all three treatment arms entered the ongoing open-label extension if they did not respond to treatment after the induction phase, relapsed during the maintenance phase or completed the maintenance phase. The objective of the extension phase was to evaluate the long-term efficacy and safety of daily ozanimod 1.0 mg. Efficacy data are reported as observed through week 92 and safety data includes all events through the data cut-off of March. At week 92, of the 100 patients who underwent efficacy evaluations, 91% had little or no active disease based on the physician global assessment, 97% had little or no blood in their stools and 86% had no blood in the stools. The safety profile at week 92 was similar to that reported in the placebo-controlled portion of the study. The most common AEs were UC flare, anemia, upper respiratory tract infection and back pain. The only SAEs in two or more patients were anemia and UC flare.
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OVID | Hot Stocks08:13 EDT Ovid Therapeutics presents 'positive' preclinical OV101 data - Ovid Therapeutics announced new positive preclinical data on OV101 that shows normalization of behavioral abnormalities that resemble those seen in people with Fragile X syndrome. The improvements seen with OV101, a novel agonist of the extrasynaptic GABA receptor, were consistent across multiple behavioral measures in a model of Fragile X syndrome. The data were presented at the 18th International Fragile X and Related Neurodevelopmental Disorders Workshop. "Treatment with OV101 results in significant behavioral improvements that are consistent across all behavioral endpoints tested," said Matthew During, M.D., DSc, FACP, FRACP, president and chief scientific officer of Ovid Therapeutics. "We designed this study to deepen our understanding of the mechanisms of action and potential benefit of OV101 to treat patients with Fragile X syndrome." In the study, researchers demonstrated that acute administration of 0.5 mg/kg of OV101 to Fmr1 knockout mice fully normalized behavioral abnormalities relevant to Fragile X syndrome. All effects were highly statistically significant. It is believed that symptoms of Fragile X syndrome are a result of disrupted tonic inhibition, the key to the brain's ability to discriminate signal from noise. The results presented indicate that by specifically targeting the delta-subset of GABA receptors, OV101 may be able to alleviate symptoms of Fragile X syndrome by modulating the GABA pathway and restoring tonic inhibition.
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CXRX | Hot Stocks08:12 EDT Concordia defers $26M unsecured interest payment - Concordia has decided to use a 30-day grace period to defer the payment of approximately $26M of interest due today on its $735M unsecured notes, in conjunction with its ongoing efforts to realign its capital structure,. The deferral of the interest payment does not result in an Event of Default until the expiry of the 30-day grace period. The company intends to use this time to continue its discussions with lenders with the goal of reaching a consensual agreement to reduce the company's debt and interest payments to create a financial foundation able to support Concordia's long-term growth. CEO Allan Oberman stated, "With approximately $340M of cash on hand as of September 30, we are confident we have sufficient liquidity in the near term to operate our business as usual while we work to achieve our financial goals, honouring our obligations to our employees, customers and suppliers and providing safe and effective medicines to our customers and patients."
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ZGNX | Hot Stocks08:11 EDT Zogenix presents interim results of Sibling Voices Survey at NORD - Zogenix announced interim results of the Sibling Voices Survey, which was developed by Zogenix to evaluate the psychosocial impact on the siblings of patients with severe childhood epilepsies, including Dravet syndrome and Lennox-Gastaut syndrome, LGS. The survey was conducted in collaboration with Lauren Schwartz, Ph.D., of the University of Washington, Department of Rehabilitation Medicine, and the results were presented at the National Organization for Rare Disorders, or NORD, and Orphan Products Breakthrough Summit, taking place October 16-17, 2017, in Washington, D.C. "In a recently conducted survey by the Dravet Syndrome Foundation, 74 percent of caregivers expressed concerns about the emotional impact on siblings of children with Dravet syndrome, and the interim results from the Sibling Voices Survey are a significant advancement in our understanding of the far-reaching implications that severe childhood epilepsies have on the lives of siblings and loved ones," said Nicole Villas, President & Scientific Director of the Dravet Syndrome Foundation Board of Directors. "We are optimistic that the insights gained from the Sibling Voices Survey will assist in the development of tools to help families, and we are grateful for Zogenix's dedication to addressing the unmet needs of this patient community." To date, there have been 183 total respondents to the Sibling Voices survey; this interim analysis focuses on the 27 youngest respondents. Of siblings aged 9-12 years old, two-thirds reported feeling worried or scared when their sibling has a seizure and the majority feel easily scared and fearful their sibling will die. Siblings in the 13-17 years old range reported concerns over their parents being stressed and/or unhappy and over half reported feeling irritable and/or easily frustrated. Many of these same group of children stated they had been talked to about the possibility of their sibling with severe epilepsy dying and indicated feeling stressed and worried by this possibility.
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RCON | Hot Stocks08:11 EDT Recon Technology, BOW sign sewage treatment strategic cooperation agreement - Recon Technology announced that it has signed a three-year strategic cooperation agreement with Beijing OriginWater Purification Engineering Technology Co., a subsidiary of Beijing OriginWater Technology Co. Ltd. Pursuant to the Agreement, Recon Technology and BOW Engineering will cooperate to promote advanced sewage treatment technology in Chinese oilfield markets and to provide integrative solutions and services of superior quality and effectiveness to tackle industrial water pollution.
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GPN | Hot Stocks08:09 EDT Global Payments announces launch of Heartland Analytics - Global Payments announced the launch of Heartland Analytics, a data insights and customer engagement software platform. Heartland Analytics is immediately available to customers in the United States. Heartland Analytics is a unified solution designed specifically for small- and medium-sized restaurant and hospitality businesses, allowing business owners to gain insight by comparing key metrics such as sales trends, customer visits, new versus repeat customer business and changes in average ticket size. The service will form the foundation for advanced analytics capabilities that Global Payments will roll out to other regions around the world throughout 2018.
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IBM | Hot Stocks08:07 EDT IBM and Dream Payments partner for mobile payment service expansion in U.S. - IBM is teaming up with Toronto-based FinTech company Dream Payments to bring new mobile payment offerings to financial institutions and merchants in the U.S. via the IBM Cloud. IBM and Dream Payments are rolling out Dream Payments Cloud to U.S. financial institutions, a scalable platform that enables financial institutions to provide business customers with mobile and digital payment services delivered via the IBM Cloud.
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AGLE MRK | Hot Stocks08:07 EDT Aeglea BioTherapeutics announces clinical collaboration with Merck - Aeglea BioTherapeutics (AGLE) announced it has entered into a clinical collaboration agreement with Merck (MRK) to evaluate the combination of Aeglea's AEB1102 with Merck's anti-PD-1 therapy, KEYTRUDA, for the treatment of patients with small cell lung cancer, or SCLC. The multicenter Phase 1/2 study will evaluate overall response rate in patients with extensive disease SCLC who have relapsed or progressed after receiving platinum-based chemotherapy. Enrollment is expected to begin in the first quarter of 2018. Additional details of the collaboration were not disclosed. The collaboration agreement is between Aeglea BioTherapeutics and Merck, through a subsidiary.
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ASM | Hot Stocks08:07 EDT Avino Silver & Gold Mines reports Q3 production results - Avino Silver & Gold Mines announces third quarter 2017 production results from its Avino property near Durango, Mexico. Highlights include: Silver equivalent production increased by 17% to 760,756 oz; Gold production increased by 47% to 2,673 oz; Silver production decreased by 10% to 368,456 oz; Copper production increased by 6% to 1,106,305 lbs. "We are pleased to report a strong quarter and that we are on pace to reach our budgeted production targets for 2017."
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ADP | Hot Stocks08:06 EDT Pershing Square announces results from ADP research survey - Pershing Square Capital Management highlighted for investors the results of an independent survey conducted by Sanford C. Bernstein & Co.about Pershing Square and ADP. The findings were published in an October 13 research report by Bernstein equity analyst Lisa Ellis. The survey polled 48 institutional shareholders, half of which own ADP stock, to understand investors' views about Pershing Square's ADP investment thesis. Notably, the survey found: 83% of ADP's current long shareholders support Pershing Square's involvement in ADP, 71% of ADP's current long shareholders support Pershing Square's nominees receiving one or more seats in the upcoming election, 83% of ADP's current long shareholders find it "somewhat compelling" or "compelling" that ADP's Employer Services should achieve operating margins of 35% or greater, and 88% of ADP's current long shareholders find it "somewhat compelling" or "compelling" that ADP's Employer Services revenue growth can be accelerated through operational improvements and a best-in-class offering in ADP's Enterprise business. Pershing Square encourages shareholders to contact Bernstein directly to receive the complete report. Pershing Square published its most recent ADP presentation on October 11. Shareholders can access that presentation here and supporting materials here. For additional information, visit our website: www.ADPascending.com. Follow ADPascending on Facebook, Twitter and YouTube. To vote for Pershing Square's Nominees for ADP's Transformation, please vote the GOLD Proxy Card or GOLD Voting Instruction Form.
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FITB MA | Hot Stocks08:06 EDT Fifth Third to join Mastercard B2B Hub powered by AvidXchange - Fifth Third Bancorp (FITB) announced a strategic relationship with Mastercard (MA) and AvidXchange to bring an automated accounts payable solution to Fifth Third Bank's clients. The collaboration is one of several recent business relationships with a financial technology company intended to bring efficiency and innovative digital solutions to clients. As part of the relationship, Fifth Third will become the first bank to join The Mastercard B2B Hub powered by AvidXchange, a solution announced earlier this year.
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ARDX | Hot Stocks08:05 EDT Ardelyx: Tenapanor reduces pain caused by IBS-C - Ardelyx reported that data from preclinical studies have shown that tenapanor works to reduce abdominal pain caused by irritable bowel syndrome with constipation through the inhibition of TRPV-1 dependent signaling. TRPV-1, better known as the "hot chili pepper receptor," is a well-established pain target known for transmitting painful stimuli from a variety of sources including heat, protons and inflammatory molecules. Tenapanor, Ardelyx's investigational, minimally systemic, small-molecule inhibitor of NHE3, has demonstrated statistically significant results in two positive Phase 3 studies in patients with IBS-C, and the ability to reduce abdominal pain and alleviate constipation. The preclinical data on tenapanor's pain mechanism are being presented by investigators from the Johns Hopkins University School of Medicine in a poster session on Tuesday, October 17, 2017 at the American College of Gastroenterology World Congress 2017. The congress is being held October 13 - 18, 2017 in Orlando, Florida.
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TECD | Hot Stocks08:05 EDT Tech Data tapped to distribute iDevices smart home products - Tech Data announced an agreement with iDevices to distribute its line of Smart Home Technology products to retailers and solution providers. iDevices manufactures a premium line of connected power, lighting and climate control solutions for homeowners, professional installers and builders.
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WTM | Hot Stocks08:05 EDT White Mountains company MediaAlpha acquires Health & Life Business - White Mountains' portfolio company, MediaAlpha, has acquired from Healthplans.com certain assets associated with its health and life insurance business. Terms of the transaction were not disclosed. This is the second add-on acquisition that MediaAlpha has closed since White Mountains acquired a majority interest in the company in 2014. The acquisition was financed with debt from MediaAlpha's existing lender, Bridge Bank, and equity funded by MediaAlpha's existing unitholders. As a result of the transaction, White Mountains' ownership in MediaAlpha increased to approximately 59% on a fully-diluted basis.
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LXU | Hot Stocks08:04 EDT LSB Industries provides update on El Dorado, Arkansas facility - LSB Industries announced that the ammonia plant at its El Dorado, Arkansas chemical facility was taken out of service on October 3 to make mechanical repairs to the burner refractory system on the boiler which were completed on October 8. Following the work on the boiler, the company determined that repairs on a process heat exchanger were necessary. LSB management has determined that the repairs to the heat exchanger will be completed, and ammonia production will resume by October 23. The company expects to meet all customer commitments for sales in the fourth quarter of 2017 and estimates that the EBITDA impact resulting from the repair expenses and the reduced absorption of fixed costs related to the collective period of downtime will be approximately $2.5M-$3M for the fourth quarter of 2017. LSB will provide an update on the progress of the repairs at El Dorado and earlier announced Pryor repairs and the impacts of the downtime on financial results when the company reports third quarter 2017 results in late October.
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CG | Hot Stocks08:04 EDT Carlyle Group, OppenheimerFunds form joint venture - OppenheimerFunds and The Carlyle Group announced a new joint venture, which will provide global private credit opportunities for high net worth investors and advisors primarily focused on the U.S. market. The JV, which will begin operating in 2018, brings together Carlyle's core global credit expertise with OppenheimerFunds' extensive product structuring and distribution capabilities to build an alternative credit platform for HNW clients and advisors. The platform will aim to deliver long-term income solutions not generally available to accredited investors.
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HALO RHHBY | Hot Stocks08:03 EDT Halozyme initiates clinical trial of cancer candidate PEGPH20 - Halozyme (HALO) initiated a clinical trial evaluating its investigational new drug PEGPH20 with atezolizumab, an anti-PDL1 cancer immunotherapy from Genentech, a member of the Roche (RHHBY) Group, in patients with previously untreated, unresectable, locally advanced, or metastatic cholangiocarcinoma and gallbladder adenocarcinoma. The Halozyme-sponsored Phase 1b/2 trial is designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations compared with the standard chemotherapy regimens. The study is part of a clinical collaboration agreement to evaluate PEGPH20 and atezolizumab in up to eight tumor types.
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REGN SNY | Hot Stocks08:03 EDT Regeneron says dupilumab patients in study showed improvement in swallowing - Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced "positive" results from a Phase 2 investigational study of dupilumab in adults with active moderate-to-severe eosinophilic esophagitis. The study showed that patients who received dupilumab weekly reported a significant improvement in the ability to swallow versus placebo. The results of this study were presented at the World Congress of Gastroenterology held in partnership with The American College of Gastroenterology Annual Scientific Meeting. The primary endpoint of the study was the change from baseline to week 10 in the Straumann Dysphagia Instrument (SDI) score, a patient-reported measure of swallowing difficulty on a 0-9 point scale, with 9 indicating more severe symptoms. A total of 47 patients were randomized into two treatment groups in this 12-week treatment study, and both groups had a mean baseline SDI score of 6.4. At week 10, patients who received dupilumab 300 mg weekly reported a significant improvement in the ability to swallow with a three point reduction in their SDI score, 45% improvement, compared to 1.3 points, or 19% improvement, for those patients who received placebo. There were no new significant safety concerns in this trial. Higher rates of injection site reactions were observed on dupilumab versus placebo.
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IRWD | Hot Stocks08:03 EDT Ironwood to present linaclotide data at World Congress of Gastroenterology - Ironwood Pharmaceuticals announced that the company and its collaborators are presenting clinical data for linaclotide at the World Congress of Gastroenterology at the American College of Gastroenterology, on October 13-18 in Orlando, Florida. Linaclotide is a guanylate cyclase-C agonist that acts by a mechanism pioneered by Ironwood scientists. Linaclotide is marketed in the United States as LINZESS and is the U.S. branded prescription market leader for adults with Chronic Idiopathic Constipation or Irritable Bowel Syndrome with Constipation. It is also marketed in Japan as LINZESS for the treatment of adults with IBS-C, and in Europe as CONSTELLA for the treatment of adults with moderate to severe IBS-C. Linaclotide delayed release-1 is an investigational drug designed to provide targeted delivery of linaclotide to the distal small intestine and colon, where it is believed that the majority of the abdominal pain associated with IBS-C originates.Researchers will present analyses of clinical data focusing on the safety and tolerability of linaclotide in the treatment of CIC and IBS-C, and on symptom improvement with linaclotide DR1 in IBS-C. An additional presentation will focus on the effect of stool consistency on bowel movement satisfaction with treatment of patients with IBS-C or CIC.
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GE | Hot Stocks08:03 EDT GE: Rafael Santana to succeed Jamie Miller as GE Transportation CEO - Rafael Santana will succeed Jamie Miller, who will become CFO of GE on November 1, 2017.
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GE | Hot Stocks08:03 EDT General Electric names Rafael Santana as president and CEO of GE Transportation - GE announced that Rafael Santana, president and CEO of GE Latin America, has been named president and CEO of GE Transportation, effective November 1, 2017. With over 17 years of GE experience, Santana has held leadership positions in GE Oil & Gas, Power and Transportation before becoming the President & CEO of GE in Latin America. Rafael Santana will succeed Jamie Miller, who will become CFO of GE on November 1, 2017.
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IMGN | Hot Stocks08:01 EDT ImmunoGen announces INDA for IMGN632 is active, FDA completes safety review - ImmunoGen announced that the U.S. Food and Drug Administration has completed the safety review of its investigational new drug application for IMGN632 in patients with CD123-positive hematological malignancies, including acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm. Filed in mid-September, the IND is now in effect and ImmunoGen plans to open a Phase 1 study to enrollment before the end of the year. IMGN632 uses ImmunoGen's novel DGN549 IGN payload, linker, and antibody technology and in preclinical models has demonstrated an impressive therapeutic window against CD123-positive malignancies. Preclinical findings reported at the 58th American Society of Hematology Annual Meeting show that IMGN632, which alkylates DNA, had potent selective activity against AML cells with lower cytotoxicity to normal myeloid progenitor cells than an ADC designed to crosslink DNA activity. These data suggest IMGN632 has the potential to be a highly effective, yet tolerable ADC for AML patients.
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EONGY | Hot Stocks08:00 EDT E.ON invests in platform provider Cuculus; terms not disclosed - E.ON said in a statement that it "strengthens its expertise in digital and networked customer solutions with a new partnership. The company acquires a stake in Cuculus, a software start-up based in Ilmenau. Together, the partners develop solutions for the intelligent house of the future. The technical basis for this is the Internet of Things, in which different devices and systems can communicate and control each other via the Internet."
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CCUR | Hot Stocks07:55 EDT Concurrent trading halted, news pending
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AGRX | Hot Stocks07:48 EDT Agile Therapeutics presents Phase 3 results of Twirla contraceptive patch - Agile Therapeutics announced the presentation of additional results from the Phase 3 SECURE trial of its investigational low-dose combination hormonal contraceptive patch, Twirla, at the 2017 National Association for Family Planning, in Atlanta, GA. Rates of unscheduled bleeding and/or spotting decreased during the study period. Similarly, the mean length of both unscheduled and scheduled bleeding and/or spotting episodes decreased during the study period. Few subjects discontinued from the trial for bleeding-related issues, and rates of unscheduled bleeding and/or spotting decreased over the 12-month study period. The Phase 3 SECURE trial was designed to evaluate the efficacy, safety and tolerability of Twirla in 2032 healthy women, aged 18 years and over.
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TGTX | Hot Stocks07:41 EDT TG Therapeutics completes full enrollment in UNITY-CLL Phase 3 trial - TG Therapeutics announced that it has completed full enrollment in the UNITY-CLL Phase 3 clinical trial. The UNITY-CLL Phase 3 trial is a randomized study of TG-1101, the company's novel glycoengineered anti-CD20 monoclonal antibody, in combination with TGR-1202, the company's PI3K delta inhibitor, compared to an active control arm of obinutuzumab plus chlorambucil, in patients with both treatment naive and relapsed or refractory Chronic Lymphocytic Leukemia, or CLL. The UNITY-CLL trial is being conducted under Special Protocol Assessment, or SPA, agreement with the FDA. Last month, the company announced that target enrollment of 175 patients in each of the TG-1101 plus TGR-1202 and obinutuzumab plus chlorambucil arms was achieved, however, enrollment was extended to allow eligible patients who were already identified or in screening the ability to participate in the study. Completion of full enrollment has now been achieved with more than 200 patients in each of the two combination arms. Approximately 60% of patients enrolled in the combination arms were front-line and 40% were previously-treated. As per the SPA, the primary and secondary endpoint analyses will include all patients. Top-line Overall Response Rate, or ORR, data from the UNITY-CLL trial is expected in the second quarter of 2018 and the company is targeting a New Drug Application, or NDA,/ Biologics License Application, or BLA, filing for the combination of TGR-1202 and TG-1101 in the second half of 2018.
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TGTX | Hot Stocks07:39 EDT TG Therapeutics provides update on FDA meeting for GENUINE Phase 3 trial - TG Therapeutics announced that it has met with the FDA regarding the use of the results from the GENUINE Phase 3 trial to support a Biologics License Application, or BLA, filing for approval of TG-1101, the company's novel glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib. During the meeting, the FDA confirmed that accelerated approval based on Overall Response Rate, or ORR, would be a review issue. As part of the discussion, the FDA encouraged the Company to consider future available therapy in its risk/benefit analysis as part of any potential future BLA filing that may impact accelerated approval. The company and the FDA also discussed the potential use of Progression Free Survival, or PFS, results from the GENUINE trial to support the full approval of TG-1101. The company plans to have a follow-up meeting with the FDA to discuss the use of the PFS endpoint in more detail before the end of the year and also plans to monitor the regulatory landscape for new approvals of agents for previously treated high-risk Chronic Lymphocytic Leukemia, or CLL, while continuing to make preparations for a BLA filing as early as 2Q18.
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AIMT... | Hot Stocks07:36 EDT Aimmune to collaborate with Regeneron, Sanofi to study AR101 with dupilumab - Aimmune Therapeutics (AIMT) announced a clinical collaboration with Regeneron (REGN) and its strategic alliance collaborator Sanofi (SNY) to study AR101 treatment with adjunctive dupilumab in peanut-allergic patients in a Phase 2 clinical trial. Regeneron will sponsor the trial, with Aimmune to provide clinical supply of AR101 and food challenge materials. AR101 is Aimmune's investigational biologic oral immunotherapy for desensitization of patients with peanut allergy, and dupilumab is a human monoclonal antibody that inhibits signaling of IL-4 and IL-13 cytokines, which are believed to be major drivers of Type 2 inflammation. The planned Phase 2 clinical trial is expected to begin in 2018. It will explore desensitization with AR101 treatment with adjunctive dupilumab in peanut-allergic patients, with a proposed primary endpoint of tolerating a certain dose of peanut protein in a double-blind, placebo-controlled food challenge that will include doses matching and exceeding those being tested in current AR101 studies. The study also includes a proposed exploration of sustained unresponsiveness after discontinuation of therapy in another DBPCFC. Sustained unresponsiveness is achieved when, after a break in treatment, peanut-allergic patients are able to tolerate a defined amount of peanut protein with no more than mild allergic symptoms. This has been recently demonstrated with low-dose oral immunotherapy in very young children. The clinical collaboration will include the formation of an Aimmune-Regeneron/Sanofi Joint Development Committee.
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SJI SO | Hot Stocks07:36 EDT South Jersey acquires Elizabethtown, Elkton Gas from Southern Company for $1.7B - South Jersey Industries (SJI) announced it has entered into agreements to acquire the assets of New Jersey-based Elizabethtown Gas and Maryland-based Elkton Gas from Pivotal Utility Holdings, Inc., a subsidiary of Southern Company Gas (SO). Upon the successful completion of this transaction, SJI will become the second largest natural gas provider in New Jersey, with service to more than 675,000 customers. In addition to Elizabethtown Gas' 288,000 customers, the company will also add over 6,000 customers in Maryland as part of the deal. SJI is acquiring both companies for total consideration of $1.7B, with an effective purchase price of $1.4B after taking into consideration the present value of tax benefits associated with the transaction. SJI expects the transaction to be accretive to earnings by 2020, the first full year of operation post transaction impacts, without synergies. The transaction is expected to close in mid-2018, and is subject to approvals by the New Jersey Board of Public Utilities and the Maryland Public Service Commission, with limited approvals by the Federal Energy Regulatory Commission and the Federal Communications Commission. In addition, the transaction is subject to the requirements of the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The transaction is expected to be earnings accretive, without synergies, by 2020.
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PEI | Hot Stocks07:35 EDT Pennsylvania REIT raises $289M since September - PREIT has raised $289M in total capital since the beginning of September, generating over $100M in net proceeds. The company has closed on the early refinancing of the mortgage loan on Lehigh Valley Mall generating proceeds of $37M, at the company's share. The new $200M loan bears interest at 4.06% and matures in 10 years. The company has now satisfied all material mortgage maturities through June 2019 with the exception of one, which is currently in active discussions and completed the redemption-in-full of its $115M Series A Preferred Shares. In addition, the underwriters of the Series D Preferred Shares exercised a $5M overallotment option.
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BR | Hot Stocks07:34 EDT Earthport chooses Broadridge to host FX, cash management processing - Broadridge Financial announced that Earthport has chosen Broadridge's hosted service for Foreign Exchange and Cash Management processing. Broadridge's fully integrated solution will enable Earthport to achieve automation and operating efficiency, seamlessly connecting all processes in the business value chain. As a result, Earthport will be able to handle a significantly larger volume of FXL deals, enabling them to better scale and grow their operation. The solution will eliminate many manual processes and drive higher levels of straight-through processing at Earthport, allowing the business to grow and scale profitability while maintaining tight controls on operations and technology.
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CODX | Hot Stocks07:33 EDT Co-Diagnostics to present Zika tests to Dominican Republic Ministry of Health - Co-Diagnostics announced upcoming meetings with the Ministry of Public Health and Social Assistance of the Dominican Republic to discuss the company's products. The meetings will take place the week of October 16, 2017, with senior officials of the Centro Nacional de Control de Enfermedades Tropicales, a division of SESPAS responsible for the prevention and control of malaria, dengue, intestinal parasites, Schistosomiasis, and the elimination of lymphatic filariasis for the 10.65 million residents of the Dominican Republic. Co-Diagnostics representatives will present the both the Company's Zika virus and tuberculosis qPCR tests as diagnostic solutions to those diseases in the region, and will demonstrate diagnostic equipment for which the Company is an authorized reseller. The equipment and tests are optimized to work together to provide complete diagnostics systems to laboratories worldwide that are in need of upgraded facilities, and highly accurate molecular tests and analysis at competitive prices.
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NVCR | Hot Stocks07:33 EDT Novocure announces lung cancer data presentations at IASLC conference - Novocure announced five data presentations at the International Associations for the Study of Lung Cancer 18th World Conference on Lung Cancer, October 15 to October 18 in Yokohama, Japan. "We look forward to having our research on Tumor Treating Fields presented at the world's largest meeting dedicated to lung cancer and other thoracic malignancies," said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development. "Lung cancer is the most common cause of cancer death worldwide. TTFields shows promise in multiple solid tumor types, including some of the most aggressive forms of cancer. We are committed to researching TTFields as a treatment for multiple solid tumor types and sharing our findings with the scientific community."
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ZKIN | Hot Stocks07:32 EDT ZK International Group signs $2M contract with Huawei Technologies - ZK International Group has signed an initial pipeline infrastructure contract with Huawei Technologies, a global information and communication technology solutions provider, for $2M. Huawei has allocated an estimated $2B for the construction of housing facilities specifically for its employees. ZK International will be providing its patented water pipeline infrastructure for the development and renovation of the $1.52B dollar 'Songshan Campus Employee Apartment Project' and as well as renovation work on the $561M 'Suzhou Campus Project'.
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DRNA | Hot Stocks07:32 EDT Dicerna files clinical trial application for DCR-PHC for Phase 1 study in PH - Dicerna Pharmaceuticals announced the first submission of a clinical trial application to the Medicines and Healthcare products Regulatory Agency in the United Kingdom to initiate a Phase 1 clinical trial of DCR-PHXC, the company's most advanced GalXC product candidate, for the potential treatment of primary hyperoxaluria. PH is a group of severe, rare, inherited disorders of the liver that often result in kidney failure. Once the CTA is authorized by the MHRA and local ethics committees, Dicerna plans to begin its Phase 1 clinical study in healthy volunteers and in patients with PH types 1 and 2 at trial sites in the United Kingdom. The company plans to submit additional CTAs in other European countries later this year. Once the CTA is authorized by the MHRA, Dicerna plans to conduct the Phase 1 trial as a randomized, single-blind, placebo-controlled, single-ascending dose study, enrolling up to 25 healthy volunteer subjects and up to 16 patients with PH. The primary objective of the study is to evaluate the safety and tolerability of single doses of DCR-PHXC, with participants being enrolled into as many as five sequential cohorts of increasing doses. Patients with PH will be dosed after safety has been established at the same dose level in normal healthy volunteers. Secondary endpoints include the pharmacokinetics of DCR-PHXC and its pharmacodynamic effects on oxalate biomarkers in plasma and urine. In animal models of PH, DCR-PHXC selectively silences LDHA in the liver, blocking the excess production of oxalate, a hallmark of the disease. In preclinical studies of DCR-PHXC, the compound was well tolerated with no adverse effects in the liver.
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SO | Hot Stocks07:31 EDT Southern Company to sell Elizabethtown, Elkton Gas to South Jersey in $1.7B deal - Southern Company and Southern Company Gas announced that Pivotal Utility Holdings, Inc., a subsidiary of Southern Company Gas, has entered into agreements to sell the assets of its utility operating divisions Elizabethtown Gas and Elkton Gas to South Jersey Industries in an all-cash transaction with an enterprise value of approximately $1.7B. Southern Company Gas is a subsidiary of Southern Company. The transaction, which is expected to be operationally seamless to customers, is designed to ensure that Elizabethtown Gas and Elkton Gas will continue their customer-focused business model and strong commitment to safety, reliability, excellent customer service and giving back to the communities where they are privileged to serve. The transaction will involve, among other things, approval by the NJBPU and MPSC (with respect to the Elkton Gas sale), the expiration or termination of any applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and certain limited approvals by the Federal Energy Regulatory Commission and the Federal Communications Commission.
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EGL | Hot Stocks07:31 EDT Engility awarded $63M in tak orders with U.S. Air Force Medical Service - Engility Holdings won $63M in task orders with the U.S. Air Force Medical Service. Working with their Medical Coding Program Office, Engility will deliver healthcare informatics, medical coding, training and compliance expertise at 14 Air Force bases.
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IBIO AMED | Hot Stocks07:22 EDT iBio announces manufacturing collaboration with Amedisys - iBio (IBIO) announced the establishment of an agreement with Aethlon Medical (AMED) to support potential large-scale production of the Aethlon Hemopurifier blood purification device. Aethlon Medical is a therapeutic technology company focused on unmet needs in global health and biodefense. The companies previously confirmed the feasibility of using a proprietary recombinant lectin protein, Galanthus nivalis agglutinin, or GNA, produced with iBio's unique plant-based technology, to increase the performance of Aethlon's Hemopurifier blood purification device. Scientists from the two companies worked together to produce and screen a panel of recombinantly produced lectin isoforms to improve binding capacity and to replace reliance on less effective extracted mixtures.
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AEMD IBIO | Hot Stocks07:17 EDT Aethlon Medical announces large-scale production pact with iBio - Aethlon Medical (AEMD) announced that it has established a collaboration with iBio (IBIO) to support potential large-scale production of the Aethlon Hemopurifier. iBio is a leading developer of plant-based biopharmaceuticals. The Aethlon Hemopurifier is a first-in-class therapeutic device designed to address life-threatening viral infections. The United States FDA has designated the Hemopurifier to an Expedited Access Pathway related to the treatment of life-threatening viruses that are not addressed with approved therapies. The goal of the Aethlon-iBio collaboration is to advance large-scale production of a recombinant form of Galanthus nivalis agglutinin, a plant-derived lectin that is immobilized within the Hemopurifier to bind infectious enveloped viruses. Aethlon further disclosed that it completed a feasibility study with iBio researchers that has confirmed the ability to produce highly active recombinant GNA through the use of iBio's plant based technology.
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CARA | Hot Stocks07:16 EDT Cara announces 'successful' end-of-phase 2 meeting with FDA for I.V. CR845 - Cara Therapeutics announced the successful completion of its End-of-Phase 2 Meeting with the FDA. The company, in consultation with the FDA, has established the key elements of the Phase 3 program to support a New Drug Application, or NDA, for I.V. CR845 for the treatment of moderate-to-severe chronic kidney disease-associated pruritus, or CKD-aP, in hemodialysis patients. The FDA previously granted Breakthrough Therapy designation to I.V CR845 for moderate-to-severe CKD-aP, for which there are currently no approved therapies in the United States. The End-of-Phase 2 discussion was supported by positive top-line results from an eight-week clinical trial of I.V. CR845 in 174 hemodialysis patients with moderate-to-severe pruritus. The trial met both its primary endpoint, with a 68 percent reduction in worst itching scores versus placebo after an eight-week treatment period, and its secondary endpoint, with a 100 percent improvement in quality of life domains versus placebo. I.V. CR845 was well-tolerated in the trial.
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INO RHHBY | Hot Stocks07:14 EDT Inovio begins Phase 1b/2 cancer efficacy trial - Inovio Pharmaceuticals (INO) announced initiation of a phase 1b/2 immuno-oncology trial to evaluate Genentech/Roche's atezolizumab in combination with Inovio's INO-5401, a T cell activating immunotherapy encoding multiple antigens, and INO-9012, an immune activator encoding IL-12. The multi-center, open-label efficacy trial will be managed by Inovio, and Genentech (RHHBY) will supply atezolizumab.
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ZIOP | Hot Stocks07:11 EDT Ziopharm: first patient dosed in Phase 1 study of Ad-RTS-hIL-12 plus Veledimex - Ziopharm announced that the first patient has been dosed in a new Phase 1 study of Ad-RTS-hIL-12 with veledimex for the treatment of pediatric brain tumors. This open label study will assess the safety and tolerability of a single intratumoral injection of Ad-RTS-hIL-12, a gene therapy designed to control the expression of human interleukin 12, or hIL-12, a critical protein for stimulating a localized anti-cancer immune response. The study is conducted in two groups: the first is comprised of pediatric patients with recurrent or progressive brain tumors in the cortex, while the second is comprised of pediatric patients with diffuse intrinsic pontine glioma, or DIPG.
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PX LNEGY | Hot Stocks07:11 EDT Linde, Praxair combination receives antitrust clearance in Russia - In accordance with the exchange offer document published on August 15, Linde (LNEGY) announced that the proposed business combination between Praxair (PX) and Linde received unconditional antitrust clearance in Russia, satisfying a closing condition. Linde is a newly incorporated public limited company formed on April 18, that will become the parent company of Praxair and Linde upon the completion of the business combination. The business combination remains subject to the satisfaction of other transaction closing conditions, including achieving the minimum acceptance ratio of 75% in Linde exchange offer for Linde AG shares, and the receipt of all other regulatory approvals and certain other customary closing conditions. The acceptance period for Linde exchange offer will expire on October 24 at 24:00 hours, unless extended. The business combination is expected to be completed in 2H18.
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ALKS | Hot Stocks07:11 EDT Alkermes to present new data on ALKS 8700 at MSParis2017 - Alkermes announced that two posters on ALKS 8700, a novel, oral monomethyl fumarate prodrug candidate in development for the treatment of relapsing forms of multiple sclerosis, will be presented at MSParis2017, the 7th Joint Meeting of the European Committee for Treatment and Research in Multiple Sclerosis and the Americas Committee for Treatment and Research in Multiple Sclerosis, being held Oct. 25-28, 2017 in Paris, France. Interim safety and gastrointestinal tolerability data during the first three months of treatment with ALKS 8700 from the ongoing two-year, open-label, phase 3 safety study will be presented. A poster detailing the study design for the ongoing phase 3 GI tolerability study comparing ALKS 8700 to TECFIDERA will also be presented. "We designed ALKS 8700, a MMF prodrug with distinct physical-chemical properties, to harness the efficacy of monomethyl fumarate with a differentiated safety and tolerability profile," said Elliot Ehrich, M.D., EVP of Research and Development at Alkermes. "The presentations at MSParis2017 will provide additional insight into the emerging safety and tolerability profile of ALKS 8700 and the potential of ALKS 8700 to provide patients suffering from MS with an important treatment alternative."
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AVEO BMY | Hot Stocks07:09 EDT AVEO Oncology to present results from Phase 1 portion of TiNivo study - AVEO Oncology (AVEO) announced that results from the Phase 1 portion of the Phase 1/2 TiNivo study will be presented in an oral presentation at the 16th International Kidney Cancer Symposium, to be held November 3-4, 2017 in Miami. The TiNivo trial is a Phase 1/2 multicenter trial of FOTIVDA in combination with Bristol-Myers Squibb's (BMY) OPDIVO, an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced renal cell carcinoma. As previously reported, the Phase 1 portion of the trial enrolled six patients, and found that the combination of tivozanib and nivolumab was well tolerated to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities. Enrollment in the Phase 2 portion in ongoing. The trial is being led by the Institut Gustave Roussy in Paris under the direction of Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee.
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NGHC | Hot Stocks07:09 EDT National General sees $25M-$30M in losses from Hurricane Irma in Q3 - National General announced that it expects Q3 results to include $25M-$30M in losses from Hurricane Irma, or $17.5M-$21M after-tax, and $5M in losses from Hurricane Maria, or $3.5M after-tax, both net of quota share reinsurance recoverables. Total net hurricane losses for the quarter, including the previously disclosed losses from Hurricane Harvey of $25M-$30M, or $17.5M-$21M after-tax, will impact the third quarter by $55M-$65M, or $38.5M-$45.5M after-tax.
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IPSEY EXEL | Hot Stocks07:08 EDT Ipsen says Phase 2 Celestial trial of cabozanitinib met primary endpoint of OS - Ipsen (IPSEY) and its partner Exelixis (EXEL) announced that its global phase 3 CELESTIAL trial met its primary endpoint of overall survival, with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma. The independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis. CELESTIAL is a randomized, global phase 3 trial of cabozantinib versus placebo in patients with advanced HCC who have been previously treated with sorafenib. The safety data in the study were consistent with the established profile of cabozantinib. In line with and in collaboration with our partner Exelixis, Ipsen expects to file in the first half of 2018 a variation of the initial application to the EMA and other relevant regulatory agencies and to evaluate potential next steps in the development strategy for cabozantinib outside the United States and Japan as a treatment for advanced HCC in patients who have been previously treated. Detailed results from CELESTIAL will be submitted for presentation at a future medical conference. CELESTIAL is a randomized, double-blind, placebo-controlled study of cabozantinib in patients with advanced HCC conducted at more than 100 sites globally in 19 countries. The trial was designed to enroll 760 patients with advanced HCC who previously received sorafenib and may have received up to two prior systemic cancer therapies for HCC and had adequate liver function. Enrollment of the trial was completed in September 2017, and 773 patients were ultimately randomized. Patients were randomized 2:1 to receive 60 mg of cabozantinib once daily or placebo and were stratified based on etiology of the disease, geographic region and presence of extrahepatic spread and/or macrovascular invasion. No cross-over was allowed between the study arms. Based on available clinical trial data from various published trials conducted in the second-line setting of advanced HCC, the CELESTIAL trial statistics for the primary endpoint of OS assumed a median OS of 8.2 months for the placebo arm. A total of 621 events provide the study with 90 percent power to detect a 32 percent increase in median OS at the final analysis. Two interim analyses were planned and conducted at 50 percent and 75 percent of the planned 621 events.
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PFE | Hot Stocks07:08 EDT Pfizer announces Phase 2 Study results of ALK-inhibitor lorlatinib - Pfizer announced full results from the Phase 2 clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib that exhibited clinically meaningful activity against lung tumors and brain metastases in a range of patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer, including those who were heavily pretreated. Further, side effects were generally manageable and primarily mild to moderate in severity. The results were presented by Professor Benjamin Solomon, lead investigator and medical oncologist at Peter MacCallum Cancer Centre, Melbourne, Australia, today during an oral session at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer in Yokohama, Japan. Pfizer will also present data from several other lung cancer clinical programs. The Phase 2 study examined the antitumor activity and safety of lorlatinib in 275 patients with or without asymptomatic, untreated or treated brain metastases. Patients were enrolled in six cohorts based on biomarker and prior therapy. The primary endpoints were objective response rate and intracranial ORR confirmed by independent central review. Results by clinically relevant groups showed: ALK-positive treatment-naive: ORR was 90% and IC-ORR was 75%. ALK-positive previously treated with crizotinib with or without chemotherapy: ORR was 69% and IC-ORR was 68%.ALK-positive previously treated with a non-crizotinib ALK inhibitor with or without chemotherapy: ORR was 33% and IC-ORR was 42%. ALK-positive previously treated with two or three prior ALK inhibitors with or without chemotherapy: ORR was 39% and IC-ORR 48%. ROS1-positive regardless of prior treatment: ORR was 36% and IC-ORR was 56%.Lorlatinib was generally tolerable. Most adverse events were mild to moderate and were managed by dose reductions or delay or with standard medical therapy. There were no treatment-related deaths and a low rate of discontinuation due to drug-related adverse events. The most common adverse events were: hypercholesterolemia, hypertriglyceridemia, edema, peripheral neuropathy, weight increase, cognitive effects, mood effects, fatigue, diarrhea, arthralgia, and increased AST. The Phase 2 data will form the basis of discussions with global regulatory authorities, including the U.S. Food and Drug Administration. On April 26, 2017, the FDA granted Breakthrough Therapy designation for lorlatinib for the treatment of patients with ALK-positive metastatic NSCLC previously treated with one or more ALK inhibitors.
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OMER | Hot Stocks07:06 EDT Omeros to present OMS721 Phase 2 data at ESBMT in Spain - Omeros Corporation announced that data will be presented from the company's Phase 2 clinical trial of OMS721, Omeros' lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2, for the treatment of thrombotic microangiopathies. The presentation will be part of the "Crash course on diagnosis and treatment of noninfectious complications after HCT" at the European Society for Blood and Marrow Transplantation in Granada, Spain. Details relating to the presentation are as follows: Title: Effective treatment of GvHD associated Transplant-associated Microangiopathy with a novel inhibitor of the lectin pathway of complement.
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SMTS | Hot Stocks07:06 EDT Sierra Metals reports Q3 production results - Sierra Metals is pleased to report third quarter 2017 production results featuring the highest quarter of throughput and second highest quarter of metal production to date from the Yauricocha Mine. Results are from Sierra Metals' three underground mines in Latin America: the Yauricocha polymetallic Mine in Peru and the Bolivar copper and Cusi silver Mines in Mexico. Third Quarter 2017 Production Highlights: Silver equivalent production of 2.7M ounces; an 8% decrease from Q3 2016. Copper equivalent production of 23.5M pounds; an 8% decrease from Q3 2016. Total tonnes processed of 504,751; a 6% decrease from Q3 2016. Increase of 3% in silver equivalent production and 13% increase in throughput at Yauricocha during Q3 2017 vs Q3 2016. During the third quarter of 2017, consolidated metal production decreased 8% compared to Q3 2016. The decrease in metal production was due to lower production in Mexico which was partially offset by record throughput in Peru. The temporary decline in production in Mexico was mainly due to the implementation of a new plan to improve operational performance and produce profitable silver ounces at Cusi and improve efficiencies at our Bolivar copper mine. Like the successful program at Yauricocha in Peru, the Company has engaged in an operation turnaround program in Mexico to modernize operations, improve production and lower costs. "We expect to see the results from this program become more apparent in the latter part of 2017 and early 2018."
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XPER TSM | Hot Stocks07:05 EDT Xperi's Tessera says TSMC seeking to 'circumvent jurisidiction' of the ITC - Tessera Technologies, a wholly owned subsidiary of Xperi Corporation (XPER), issued a statement in response to litigation filed by Taiwan Semi (TSM), against Tessera and certain of its subsidiaries late in the day on October 13, 2017. TSMC filed an action in the United States District Court for the Northern District of California, expressing its concern that the U.S. International Trade Commission will adopt the initial determination of Administrative Law Judge Sandra Dee Lord and enter an order excluding the import of infringing Broadcom chips manufactured by TSMC, and products of the other respondents containing these chips. TSMC seeks an injunction to prevent Tessera from enforcing its rights in the ITC. TSMC's request is based on the same patent exhaustion argument that was already fully litigated and rejected by ALJ Lord in the ITC investigation. "This appears to be an eleventh-hour attempt by TSMC to circumvent the jurisdiction and lawful authority of the ITC, which protects U.S. industries against the importation of foreign infringing products," said Paul Davis, Xperi's senior vice president and general counsel. "But ALJ Lord already considered the argument TSMC raises, and concluded that TSMC does not have the right to sell products that infringe our '946 patent. We are confident that the District Court will reject TSMC's belated attempt to end-run the ITC and re-litigate this issue."
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CSIQ | Hot Stocks07:04 EDT Canadian Solar enters contracts to sell interests in Australian solar farms - Canadian Solar announced that it has entered into binding contracts to sell interests in three solar farms in Queensland, Australia, with an aggregate 117 MWp of capacity to Foresight Solar Fund Limited. The portfolio consists of Longreach Solar Farm (17 MWp), Oakey 1 Solar Farm (30 MWp) and Oakey 2 Solar Farm (70 MWp) with FSFL acquiring 49% interests in each of Longreach and Oakey 1, and a 100% interest in Oakey 2. Two of the three solar farms (Oakey 1 and Longreach) hold 20-year offtake agreements with the Queensland Government and are under construction with connection to the grid expected in March and September 2018 respectively. Oakey 2 solar farm is expected to connect to the grid in October 2018 and will benefit from the sale of power and large-scale generation certificates under the Renewable Energy Target regulatory framework. Both Oakey 1 and Longreach have been funded to date by equity from Canadian Solar, grants from the Australian Renewable Energy Agency, and senior debt from the Clean Energy Finance Corporation and Bank of Tokyo-Mitsubishi UFJ. The completion of the acquisitions is subject to certain conditions being met including consents from relevant stakeholders.
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CUB | Hot Stocks07:02 EDT Cubic unit awarded $5M contract to support New Zealand Defence Force - Cubic announced that GATR Technologies, a subsidiary which operates within the Cubic Mission Solutions business division, was awarded an order worth more than $5M to provide satellite communication solutions for the New Zealand Defence Force. Cubic will supply 2.4-meter inflatable satellite antennas with supporting hardware, spares and New Equipment Training for the NZDF Network Enabled Army program. In addition to a multi-year support contract, Cubic will deliver and integrate an iDirect-based, time division multiple access network within the NZDF's existing and future hub infrastructure.
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FMI | Hot Stocks07:01 EDT Foundation Medicine to present validation for FoundationOne CDx - Foundation Medicine announced that the company will present validation data for FoundationOne CDx, its comprehensive genomic profiling assay, at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer . Data demonstrated high concordance with multiple companion diagnostics and other single marker assays currently used to match targeted therapies to people with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer or breast cancer. The availability of a comprehensive genomic profiling assay that is concordant with multiple companion diagnostics has the potential to advance personalized healthcare for all constituents by providing biopharma companies a platform for accelerated drug development and by improving efficient access to targeted therapies for patients.
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EXEL | Hot Stocks07:00 EDT Exelixis announces U.S. FDA grants priority review for CABOMETYX - Exelixis announced that the U.S. FDA has determined the company's supplemental New Drug Application for CABOMETYX for patients with previously untreated advanced renal cell carcinoma to be sufficiently complete to permit a substantive review. The FDA granted Priority Review of the filing and assigned a Prescription Drug User Fee Act action date of February 15, 2018.
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EXEL | Hot Stocks06:59 EDT Exelixis Phase 3 CELESTIAL trial of Cabozantinib meets primary endpoint - Exelixis announced that its global phase 3 CELESTIAL trial met its primary endpoint of overall survival, with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma. The independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis. CELESTIAL is a randomized, global phase 3 trial of cabozantinib versus placebo in patients with advanced HCC who have been previously treated with sorafenib. The safety data in the study were consistent with the established profile of cabozantinib. Based on these results, Exelixis plans to submit a supplemental New Drug Application to the U.S. FDA in the first quarter of 2018. Detailed results from CELESTIAL will be submitted for presentation at a future medical conference.
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USDP | Hot Stocks06:56 EDT USD Partners begins operations at Stroud destination terminal - USD Partners announced the successful commencement of operations at its destination terminal in Stroud, Oklahoma on October 1. The planned retrofit work necessary to handle heavier grades of crude oil at the terminal was completed on time and under the Partnership's initial budget. Approximately 50% of the Stroud terminal's current capacity is available and actively being marketed to meet the takeaway needs of current and future customers.
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JKS | Hot Stocks06:54 EDT JinkoSolar supplies 12.7 MW of PV modules for solar plant in Ulan Bator - JinkoSolar announced that it supplied 12.7 MW of PV modules to Hitachi Systems, a subsidiary of Hitachi, Ltd., for a solar plant owned by Farmdo in Ulan Bator, Mongolia. JinkoSolar delivered 12.7 MW of its high efficiency PERC modules and custom built 36-cell and 48-cell dual glass modules. This shipment marks JinkoSolar's first to the country. The power plant is the country's first utility scale solar plant which covers 28 hectares of land and is expected to be connected to the grid in November 2017. Supported by the Japanese Ministry of the Environment, 40% of the project's construction fees will be financed using a government subsidy. JinkoSolar is currently bidding as a competitive candidate for two other projects managed by Hitachi Systems where construction is expected to begin in 2018.
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LLY | Hot Stocks06:53 EDT Eli Lilly says NSCLC patients shown to benefit in new Cyramza subgroup analysis - New subgroup analysis from Eli Lilly's Phase 3 REVEL trial of Cyramza in advanced non-small cell lung cancer, or NSCLC, was presented today at the 18th World Conference on Lung Cancer, or WCLC, hosted by the International Association for the Study of Lung Cancer in Yokohama, Japan. Specifically, these new data are an exploratory, post-hoc analysis focused on patients whose cancer rapidly progressed on first-line therapy. Time-to-progression, or TTP, is defined as the time from start of first-line therapy until progressive disease - when the person's cancer grows, spreads or gets worse. In this analysis, aggressive disease was defined based on rapid TTP on first-line therapy. The global, randomized, double-blind, placebo-controlled REVEL Phase 3 study evaluated ramucirumab, in combination with docetaxel, in patients with metastatic NSCLC whose cancer had progressed on or after prior platinum-based chemotherapy for locally advanced or metastatic disease. REVEL, which included patients with nonsquamous and squamous forms of NSCLC, demonstrated improved overall survival, or OS, progression-free survival, or PFS, and objective response rate, or ORR, - independent of histology. Please see the 'About REVEL' section below for more detailed efficacy and safety results in the trial's intent-to-treat, or ITT, patient population. The REVEL ITT trial results, presented at the American Society of Clinical Oncology Annual Meeting in 2014, supported the FDA approval of ramucirumab in NSCLC in December 2014.
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LDOS | Hot Stocks06:48 EDT Leidos one of ten primes awarded contract by U.S. Army - Leidos was one of ten primes awarded a contract by the U.S. Army to continue its 24 years of excellence in providing technical development, technical support, and operational integration to the U.S. Army's Research, Development, and Engineering Command's Communications and Electronic Research, Development, and Engineering Center's Night Vision and Electronic Sensors Directorate, or NVESD, under the Deployable Adaptive Global Responder Support program. The multiple-award indefinite-delivery/indefinite-quantity contract has a five-year base period of performance and a total contract value of $480M.
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BRO | Hot Stocks06:46 EDT Brown & Brown announces asset acquisition of Universal Benefit Solutions - J. Scott Penny, Chief Acquisitions Officer of & Brown, and Brandon Brickweg, the founder of Universal Benefit Solutions, announced that Pacific Resources Benefit Advisors, a subsidiary of Brown & Brown, has acquired substantially all of the assets of UBS. UBS represents large company clients in the placement of ancillary employee benefits products and has annual revenues of approximately $2.5M. The UBS team will become part of the Pacific Resources profit center, which operates under the direction of Barrett Brown, Regional President of Brown & Brown.
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IBM | Hot Stocks06:43 EDT IBM announces blockchain global banking solution - IBM announced a new blockchain banking solution that will help financial institutions address the processes of universal cross-border payments, designed to reduce the settlement time and lower the cost of completing global payments for businesses and consumers. Using IBM Blockchain, and in collaboration with technology partners Stellar.org and KlickEx Group, the solution is intended to improve the speed in which banks both clear and settle payment transactions on a single network in near real time. The solution is already processing live transactions in 12 currency corridors across the Pacific Islands and Australia, New Zealand and the United Kingdom. Using a blockchain distributed ledger, all appropriate parties have access and insight into the clearing and settlement of financial transactions. It is designed to augment financial flows worldwide, for all payment types and values, and allows financial institutions to choose the settlement network of their choice for the exchange of central bank-issued digital assets. IBM has convened an initial group of diverse banking leaders as part of the development and deployment process, including Banco Bilbao Vizcaya Argentaria, Bank Danamon Indonesia, Bank Mandiri, Bank Negara Indonesia, Bank Permata, Bank Rakyat Indonesia, Kasikornbank Thailand, Mizuho Financial Group, National Australia Bank, Rizal Commercial Banking Corp. Philippines, Sumitomo Mitsui Financial Group, TD Bank, Wizdraw of WorldCom Finance, and other financial institutions.
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SYF | Hot Stocks06:24 EDT Synchrony reports September net charge-off rate 4.16% vs. 4.86% last month - Reports September 30-plus day delinquency rate 3.19% vs. 2.94% last month.
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JPM | Hot Stocks06:21 EDT JPMorgan reports September net credit losses 2.32% vs. 2.41% last month - Reports September 30-plus day delinquencies 1.22% vs. 1.16% last month.
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ABIL | Hot Stocks06:08 EDT Ability receives Nasdaq letter of non compliance - Ability announced that on October 11, it received notification from the Listing Qualifications Department of The Nasdaq Stock Market that the company is not in compliance with the minimum bid price requirement set forth in Nasdaq's Listing Rule 5550(a)(2). Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the company's ordinary shares for the 30 consecutive business days ended October 10, the company no longer meets the minimum bid price requirement. The deficiency notification does not result in the immediate delisting of the company's ordinary shares from the Nasdaq Capital Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the company has an initial grace period of 180 calendar days, or until April 9, 2018, to regain compliance with the minimum bid price requirement. If, at any time during the Compliance Period, the bid price for the company's ordinary shares closes at $1.00 or more for a minimum of 10 consecutive business days, the Staff will provide notification to the company that it complies with the minimum bid price requirement, unless the Staff exercises its discretion to extend this 10-day period requirement pursuant to Nasdaq Listing Rule 5810(c)(3)(F). If the company does not regain compliance with the minimum bid price requirement during the Compliance Period, the company may be afforded an additional 180 calendar day period to regain compliance. To qualify, the company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, except for the minimum bid price requirement. In addition, the company would be required to notify Nasdaq of its intent to cure the minimum bid price deficiency. If the company does not regain compliance with the minimum bid price requirement during the Compliance Period and is not eligible for an additional compliance period at that time, the Staff will provide notification to the company that its ordinary shares may be delisted. The company would then be entitled to appeal the Staff's determination to a Nasdaq Listing Qualifications Panel and request a hearing. There can be no assurance that, if the company does appeal the delisting determination by the Staff to the Nasdaq Listing Qualifications Panel, such appeal would be successful. At present, the company intends to monitor the closing bid price of its ordinary shares and may, if appropriate, consider available options to regain compliance with the minimum bid price requirement, which could include effecting a reverse stock split. However, there can be no assurance that the company will be able to regain compliance with the minimum bid price requirement.
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FTS | Hot Stocks06:05 EDT Fortis announces 5-year capital investment plan of about $14.5B for FY18-FY22 - Fortis announced its five-year capital investment plan of approximately $14.5B for the period 2018 through 2022, up $1.5B from the prior year's plan. The corporation's board also announced a 6.25% increase in Q4 common share dividend. The corporation's capital investment plan is comprised mostly of a diversified mix of highly executable, low-risk projects and is fully funded through debt raised at the utilities, cash from operations and common equity from the corporation's dividend reinvestment plan. As a result, consolidated rate base is projected to increase from over $25B in 2017 to approximately $32B in 2022.
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FTS | Hot Stocks06:03 EDT Fortis raises quarterly dividend by 6.25% to 42.5c per share - The Fortis board declared a common share dividend of 42.5c per share on the issued and outstanding fully paid common shares of the corporation, payable on December 1, 2017 to the common shareholders of record at the close of business on November 20. In addition, the Corporation has targeted average annual dividend per common share growth of approximately 6% through 2022 based on an annual dividend of $1.60.
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FENC | Hot Stocks06:03 EDT Fennec says Phase 3 SIOPEL 6 study met primary endpoint - Fennec Pharmaceuticals announced data from its Phase 3 SIOPEL 6 study presented during the late breaker session on Saturday, October 14, 2017 at SIOP 2017 in Washington, DC. The SIOPEL 6 study met its primary endpoint. The study demonstrated that the addition of STS significantly reduces the incidence of cisplatin-induced hearing loss without any evidence of tumour protection. Among the 99 evaluable patients, hearing loss occurred in 30/45=67% treated with Cisplatin alone and in 20/54=37.0% treated with Cis+STS, corresponding to a relative risk of 0.56(P=0.0033). Fennec plans to pursue regulatory approval for PEDMARKTM based on the data from the SIOPEL 6 study along with the proof of principle data from COG ACCL0431. STS has received Orphan Drug Designation in the US in this setting and plans to pursue European Market Exclusivity for Pediatric Use upon approval. The company also reported top-line data for secondary endpoints Event Free Survival and Overall Survival. The combination of Cis+STS was generally well tolerated. With a follow up of 52 months, 3yr EFS is Cis 78.8% and Cis+STS 82.1%; 3yr OS is Cis 92.3% and Cis+STS 98.2%.
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KBR | Hot Stocks06:01 EDT KBR to acquire Sigma Bravo - KBR announced it has entered a definitive agreement to acquire Sigma Bravo Pty Ltd, a provider of high-end Information and Communication Technology, or ICT, services specializing in mission planning systems and solutions to the Australian Defence Force, or ADF. Sigma Bravo delivers an array of specialist Aerospace ICT based solutions supporting ADF's critical mission planning and information management systems and programs. The acquisition of Sigma Bravo represents KBR'S entry into classified work in Australia and is a continued element of KBR's strategy to expand its global Government Services offerings. Sigma Bravo will become a KBRwyle company reporting within KBR's Government Services segment and will maintain its current structure to ensure business continuity.
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TSM | Hot Stocks05:58 EDT TSMC purchases another 100M kWh in green power - TSMC announced that it will purchase another 100 million kilowatt hours of green power, and also plans to directly purchase renewable energy, continuing the company's support for global carbon reduction. As green power does not create carbon emissions in the generation process, this 100 million kWh can reduce approximately 52.9 million tons of carbon emissions, equivalent to the amount absorbed by 5.29 million trees in one year.
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BMY | Hot Stocks05:42 EDT Bristol-Myers says Opdivo shows encouraging response, survival rates - Bristol-Myers announced data evaluating Opdivo and Opdivo plus Yervoy in previously treated small cell lung cancer, or SCLC, patients whose tumors were evaluable for tumor mutation burden, or TMB, from the Phase 1/2 CheckMate -032 trial. The primary objective of this trial was objective response rate, or ORR, as assessed by a blinded independent central review, or BICR, for which results were previously presented; in the pooled intent-to-treat, or ITT, population, the ORR was 11% with Opdivo alone and 22% with the combination. Among the ITT population, 211 patients had an evaluable TMB result for these analyses and were divided into subgroups of high, medium and low levels of TMB. Patients with high TMB who received Opdivo plus Yervoy had an ORR of 46%; the ORR was 16% and 22% in patients with medium and low levels of TMB, respectively. Patients with high TMB who received Opdivo had an ORR of 21%; the ORR was 7% and 5%, in patients with medium and low levels of TMB, respectively. In patients with high TMB who received Opdivo plus Yervoy, 62% were alive at one year; 20% and 23% of patients with medium and low levels of TMB were alive at one year, respectively. In patients with high TMB who received Opdivo, 35% were alive at one year; 26% and 22% of patients with medium and low levels of TMB were alive at one year, respectively. No new safety data were presented in this analysis. Over time, cancer cells accumulate mutations that are not seen in normal cells of the body. Tumor mutation burden is a measurement of the quantity of mutations carried by tumor cells, and is one type of biomarker that may help predict the likelihood a patient responds to Immuno-Oncology therapies.
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HCM | Hot Stocks05:38 EDT Chi-Med says fruquintinib/Iressa combination showing 'promising' efficacy - Hutchison China MediTech, or Chi-Med, reported preliminary clinical activity, safety, and tolerability data of fruquintinib, an investigational selective inhibitor of vascular endothelial growth factor , or VEGF, receptor given in combination with Iressa. These data were from an ongoing Phase II proof-of-concept trial conducted in patients with epidermal growth factor receptor, or EGFR, mutation-positive, or EGFRm, non-small cell lung cancer, or NSCLC. Preliminary data from this Phase II proof-of-concept trial, the first study assessing combining fruquintinib with another tyrosine kinase inhibitor, demonstrated promising efficacy and an acceptable safety profile. Preliminary results in 17 efficacy evaluable patients showed an overall response rate of 76% and a disease control rate of 100%. Four partial responses were not yet confirmed at the time of data cut-off.
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MAR... | Hot Stocks05:35 EDT Marriott expects to receive about $650M in Avendra sale to Aramark - Marriott (MAR) announced that the owners of Avendra have reached a binding agreement to sell Avendra to Aramark (ARMK) for $1.35M. After redemption of management participation rights, transaction costs, and repayment of Avendra's outstanding debt, Avendra's founding shareholders, Marriott, Hyatt (H), Accor, ClubCorp (MYCC), and IHG (IHG), expect to receive approximately $1.18B in cash proceeds from the transaction. Marriott expects to receive approximately $650M for its 55% interest in Avendra. Marriott's original investment in Avendra totaled $13M and was recovered from dividends from the business. As part of the purchase agreement, also on behalf of its managed hotel system in the Americas, Marriott will enter into a 5-year procurement service agreement with Aramark. While the transaction will benefit owners and franchisees of its hotels, Marriott expects the transaction will be immaterial to its financial results.
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BCLI | Hot Stocks05:31 EDT BrainStorm enrolls first patientes in Phase 3 trial of NurOwn in ALS - BrainStorm Cell Therapeutics announced that the first patients have been enrolled in the Phase 3 clinical trial of NurOwn for the treatment of amyotrophic lateral sclerosis, or ALS, at the Massachusetts General Hospital and UC Irvine Medical Center in California. The trial is expected to enroll approximately 200 patients and will be conducted at six leading ALS clinical sites in the U.S. The primary outcome measure will be the ALSFR-S score responder analysis. The patient population will be optimized to include the pre-specified subgroups who demonstrated superior outcomes in the NurOwn Phase 2 ALS clinical trial. Top-line data are expected in 2019.
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ARMK | Hot Stocks05:30 EDT Aramark to acquire Avendra for $1.35B, AmeriPride Services for $1B - Aramark announced that it entered into definitive agreements to acquire two companies that will deliver growth and strengthen the company's competitive position across its portfolio of Food, Facilities and Uniforms businesses. Aramark and Avendra, LLC have entered into a definitive agreement under which Aramark will acquire Avendra for a purchase price of $1.35B, or a net purchase price of $1.05B after adjusting for the value of the anticipated tax benefits. The merger also creates opportunities for Aramark and Avendra to grow their customer base outside of their traditional industries. Additionally, Aramark anticipates annual procurement cost synergies of approximately $40M, which it expects will be fully realized by the third fiscal year after closing. Aramark and AmeriPride Services Inc. also announced today that they have entered into a definitive agreement under which Aramark will acquire AmeriPride for a purchase price of $1B, or a net purchase price of $850M after adjusting for the value of the anticipated tax benefits. AmeriPride is a leading uniform and linen rental and supply company in the U.S. and Canada, with annual revenue of approximately $600M. Additionally, Aramark anticipates annual cost synergies of approximately $70M, which it expects will be fully realized by the fourth fiscal year after closing. The board of Aramark has unanimously approved both transactions, which were also unanimously approved by the board of managers of Avendra and board of AmeriPride, respectively. The transactions are expected to close by the end of calendar year 2017, subject to customary closing conditions and regulatory approvals. Aramark will finance the transactions through the issuance of new debt, and has received fully committed financing.
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ARMK | Hot Stocks05:28 EDT Aramark to acquire Avendra for $1.35B, AmeriPride Services for $1B
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PCG | Hot Stocks05:21 EDT PG&E: after fires, nearly all electric customers to be restored by late Monday - More than 3,000 PG&E employees and mutual-aid partners continued to make progress restoring electric and gas service to customers in the aftermath of the unprecedented wind-driven wildfires. PG&E anticipates restoring service to essentially all electric customers who are able to receive it, and once approval to energize is granted, by late Monday. By Monday morning, PG&E expects to have completed the work necessary to ensure the safety of gas pipelines so that it can begin restoring service to the remaining 17,000 customers who do not presently have gas service, but are in a position to accept gas service. This process involves working with the individual customers to relight their pilot lights. Restoration begins once infrastructure is repaired, and areas have been deemed safe by relevant authorities. As restoration efforts continue around the clock, PG&E is maintaining an absolute focus on customer and public safety and supporting firefighting efforts on these intense wind-fueled wildfires.
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