Stockwinners Market Radar for June 23, 2017 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
SVU | Hot Stocks18:26 EDT Supervalu completes acquisition of Unified Grocers - Supervalu announced it has completed the previously announced acquisition of Unified Grocers in a transaction valued at $390M, comprised of $114M in cash to Unified Grocers' shareholders for 100% of the outstanding stock of Unified Grocers plus the assumption and pay-off at closing of Unified Grocers' net debt of approximately $276M.
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SONA EVBS | Hot Stocks18:07 EDT Southern National Bancorp, Eastern Virginia Bankshares complete merger - Southern National Bancorp of Virginia (SONA) and Eastern Virginia Bankshares (EVBS) jointly announced the completion of the merger of Eastern Virginia with and into Southern National and the completion of the merger of Eastern Virginia's wholly-owned bank subsidiary, EVB, with and into Southern National's wholly-owned bank subsidiary, Sonabank. The combination brings together two banking companies with complementary business lines, creating one of the premier banking institutions headquartered in the Commonwealth of Virginia. The combined company has approximately $2.6B in total assets, $2B in total deposits, and $1.8B in total loans. The holding company will continue to operate under the name "Southern National Bancorp of Virginia, Inc." and will maintain its corporate headquarters in McLean, Virginia. All banking operations will be conducted through Sonabank with its headquarters in Richmond, Virginia. The combined bank has 47 branch locations covering markets in both Maryland and Virginia, including the Washington, D.C. and Richmond, Virginia MSAs. These attractive markets are often cited as having some of the best demographic and income profiles in the country, frequently characterized by low unemployment, strong population growth, new business starts and consistent capital expenditure. Pursuant to the merger agreement, the holders of shares of Eastern Virginia capital stock have the right to 0.6313 shares of Southern National common stock for each share of Eastern Virginia capital stock held immediately prior to the effective date of the merger. The executive management team of the combined company will be comprised of Joe A. Shearin as President and CEO, Georgia S. Derrico as Executive Chairman and R. Roderick Porter as Executive Vice Chairman.
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IAC | Hot Stocks17:56 EDT IAC will not pursue plan to create new class of non-voting stock - IAC's Board of Directors has determined not to pursue the Company's previously announced plan to create a new class of non-voting stock. As previously reported, on December 15, 2016, IAC stockholders approved a proposed charter amendment to implement the Class C Recapitalization. Certain stockholders brought suit in the Delaware Court of Chancery against the Company and its directors, challenging that proposed charter amendment and seeking an injunction against its execution. IAC agreed not to effect the Class C Recapitalization during the pendency of the litigation. The Board of Directors of IAC met on June 21, 2017. After discussions with management of IAC and considering, among other things, recent developments in the stockholder litigation that made it unlikely that the litigation would be finally resolved until late 2018 or 2019, the burden and distraction that the litigation was likely to impose on IAC and its management, including the considerable legal and related expenses of the litigation, and other relevant information, the Board determined not to proceed with the Class C Recapitalization. As a result of the Board's determination, the parties in the Delaware litigation challenging the Class C Recapitalization have stipulated to the dismissal of the litigation on mootness grounds.
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EGL | Hot Stocks17:50 EDT Engility to eliminate position of president, COO - According to a regulatory filing, Engility Holdings determined after a a strategic review of its organizational structure to eliminate the position of president and COO, currently held by John P. Hynes, Jr. Accordingly, Hynes' employment with the company will end on June 30, 2017.
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ADM | Hot Stocks17:48 EDT ADM Animal Nutrition recalls Rough-N-Ready cattle feed over monensin concerns - ADM Animal Nutrition, a division of Archer Daniels Midland Company, is recalling 50-pound bags of Rough-N-Ready 14 BT cattle feed, product number 54787BHB24, because the product contains elevated levels of monensin beyond the recommended dosage, which could be harmful to cattle. At elevated levels, monensin can be toxic to cattle and can cause colic-like symptoms, hypokalemia, myoglobinuria, chronic cardiovascular issues, and possible death. The product was distributed between Jan. 19, 2017, and Feb. 2, 2017, and could have been purchased directly from ADM Animal Nutrition or through one of three distributors including: Midwest Fertilizer, Inc. in Iola, Kansas; CW Feeds in Wichita, Kansas and Northtown Ace in Mountain Grove, Missouri. ADM Animal Nutrition received reports from two customers claiming this feed may have resulted in death loss on their respective farms. The company immediately began investigating and initiated the recall upon receiving confirmation that the feed contained elevated levels of monensin due to a temporary breakdown in the packaging process, which has now been corrected. ADM has been in direct contact with the distributors involved in this recall, and all product has been removed from retail shelves. ADM is also working directly with the customers involved.
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IBTX TBK | Hot Stocks17:19 EDT Independent Bank to sell nine Colorado branches to TBK Bank - Independent Bank (IBTX) announced that it has signed a definitive agreement to sell nine locations in Colorado to TBK Bank, SSB, a subsidiary of Triumph Bancorp (TBK). Of the nine branches, four are located in eastern Colorado and five are located north of Denver. These branches were acquired by Independent Bank as part of Independent Bank Group's acquisition of Carlile Bancshares and its subsidiary, Northstar Bank, which closed in April 2017. In the transaction, TBK Bank will purchase approximately $100M in loans and assume approximately $168M in deposits associated with the branches for an estimated deposit premium of $7M, or 4.17%. The actual premium will be based on a 30-day average of deposit balances at the time the transaction closes.
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WUBA | Hot Stocks17:11 EDT General Atlantic reports 5.9% stake in 58.com
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FOXA... | Hot Stocks17:10 EDT Box Office Battle: 'Transformers' expected to top 'Cars 3,' 'Wonder Woman' - Viacom (VIA, VIAB) subsidiary Paramount's "Transformers: The Last Knight," the fifth installment in the transforming robots series, is expected to open domestically at about $46M, after opening Wednesday to an estimated $15.7M, the lowest single-day opening for any film in the Transformers franchise, which hints at franchise fatigue. Disney/Pixar's (DIS) "Cars 3," an animated film featuring anthropomorphic cars, is expected to take second place this weekend with a domestic gross of around $29M, after topping the box office in its opening weekend last week. Time Warner's (TWX) superhero flick "Wonder Woman," starring Gal Gadot, is expected to take third place in its fourth weekend at theaters, earning an additional $28M-$29M, which would bring the domestic total for the film to $322M. Lionsgate's (LGF.A, LGF.B) Tupac biography "All Eyez on Me" is expected to earn an additional $9M-$10M domestically, after opening last weekend with $26.4M. Other publicly traded companies in filmmaking include 21st Century Fox (FOX, FOXA), Comcast (CMCSA, CMCSK), and Sony (SNE).
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IDXG | Hot Stocks17:05 EDT Armistice Capital reports 4.99% passive stake in Interpace Diagnostics
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MNR | Hot Stocks17:02 EDT Monmouth Real Estate acquires building in Texas for $50.6M - Monmouth Real Estate Investment Corporation announced the acquisition of a brand new, 351,874 square foot, Class A industrial building located at 5005 Samuell Boulevard, Mesquite, TX at a purchase price of $50,621,072. The property is net-leased for 15 years to FedEx Ground Packaging System, Inc. The building is situated on approximately 65 acres.
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ARCW | Hot Stocks17:01 EDT ARC Group names Drew Kelley as Interim CEO, effective July 1 - ARC Group Worldwide announced the appointment of Drew Kelley as Interim CEO and Board Member, replacing Jason Young, who is leaving his position with the Company and ARC's Board to pursue other interests. Kelley has served as the Company's CFO since October 2013, and prior to joining the Company, was an accomplished investment banker and equity research analyst. The appointment will be effective July 1.
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MFSF | Hot Stocks16:48 EDT MutualFirst Financial senior executives enter 10b5-1 trading plans - On June 23, David Heeter, President and CEO, and Patrick Botts, Executive Vice President, adopted stock trading plans in accordance with the guidelines specified in Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, and pursuant to the MutualFirst Financial Insider Trading Compliance Guidelines.
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CSCO | Hot Stocks16:46 EDT Cisco CEO Charles Robbins enters 10b5-1 trading plan - On June 21, Charles Robbins, CEO of Cisco Systems, adopted a pre-arranged stock trading plan to sell up to 339,725 shares of Cisco stock acquired upon vesting of restricted stock units. The plan is scheduled to terminate in December 2017.
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SITO | Hot Stocks16:43 EDT SITO Mobile chairman Paul Pressler resigns - Effective as of June 23, 2017, the board of directors of SiteOne Landscape Supply accepted the resignations of Kenneth A. Giuriceo and Wes Robinson, according to a regulatory filing. Paul S. Pressler resigned as the chairman of the board, as a member of the Nominating and Corporate Governance Committee of the board and as a member and chairman of the Compensation Committee of the board, in each case effective as of June 23, 2017. In connection with Pressler's resignations, the board appointed Doug Black to serve as chairman of the board, Jeri L. Isbell to serve as chairman of the Compensation Committee of the board and Michael J. Grebe as a member of the Compensation Committee, in each case effective as of June 23, 2017. Following these resignations and appointments, all committees of the board will be comprised entirely of directors that the board has determined are "independent" as defined under NYSE listing standards and a majority of the members of the board will be Independent. Effective as of June 23, 2017, the board appointed William W. Douglas, III, upon selection by the majority of the Independent members of the board in accordance with the company's Corporate Governance Guidelines, as the lead director of the board.
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CFCO | Hot Stocks16:38 EDT Mason Capital reports 5.32% passive stake in CF Corporation
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FMC | Hot Stocks16:31 EDT FMC Corporation to sell Omega-3 business to Pelagia AS, terms not disclosed - FMC Corporation has signed a definitive agreement to sell its Epax Omega-3 business to Pelagia AS. The transaction is expected to close by the end of Q3 2017, subject to customary regulatory approvals and closing conditions. Terms of the transaction were not disclosed.
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VHI | Hot Stocks16:16 EDT Valhi Inc termiantes purchase deal for sale of Waste Control Specialists - As previously announced, on June 21, 2017, the U.S. District Court for the District of Delaware issued an order enjoining the sale of Waste Control Specialists, a wholly owned subsidiary of Valhi, to EnergySolutions. While Valhi disagrees with the Court's decision, the parties have determined that they will not appeal the decision to the Third Circuit Court of Appeals. On June 22, 2017, Andrews County Holdings, Inc., a subsidiary of Valhi, provided written notice to Rockwell Holdco, Inc., the parent company of EnergySolutions, terminating the purchase agreement for the sale of WCS to Rockwell effective June 22, 2017.
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GBL LSXMA | Hot Stocks16:14 EDT Gabelli reports 5.22% stake in Liberty SiriusXM
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WETF | Hot Stocks16:13 EDT WisdomTree to close, liquidate three ETFs - WisdomTree announced plans to close and liquidate three of its ETFs. The Funds will no longer accept creation orders after Wednesday, August 16, 2017. The final day of trading on the Funds' respective exchanges will also be Wednesday, August 16, 2017. Shareholders who do not sell their Fund shares by this date will have their shares automatically redeemed for cash based on the Funds' net asset value, which is expected to be provided to shareholders through their brokers or other financial intermediaries on or around Friday, August 25, 2017, the Funds' last day of operations. The funds being closed are WisdomTree Strategic Corporate Bond Fund, or "CRDT," the Western Asset Unconstrained Bond Fund, or "UBND," and the Global Real Return Fund, or "RRF."
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CONN | Hot Stocks16:11 EDT Point72 Asset reports 5.3% passive stake in Conn's
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APDN | Hot Stocks16:10 EDT Applied DNA Sciences receives order to tag 27.5M pounds of cotton - Applied DNA Sciences is pleased to announce it has received an order to tag 27.5M pounds of cotton to kick off the 2017/2018 ginning season, composed of three US cotton varietals. The three varietals are Pima, Delta and Acala, which fall under the Pimacott, HomeGrown LoneStar and HomeGrown Acala programs. The company expects to ship SigNature T DNA to mark 27.5M pounds of cotton before the end of June. For this order, the customer has agreed to more customary and favorable payment terms, allowing for earlier revenue recognition than past cotton orders. This new order is incremental to DNA concentrate to tag 30M pounds of cotton that was shipped during fiscal 2016 to establish an on-site reserve of SigNature T DNA before the harvest begins.
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MOCO | Hot Stocks16:08 EDT Gabelli liquidates stake in Mocon - As a result of the completion of the acquisition of the company by AMETEK, Inc., Gabelli no longer hs beneficial ownership of any of the company's shares.
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TIPT | Hot Stocks16:02 EDT Tiptree Financial repurchases 1M shares from Nomura Securities - Tiptree has repurchased 1M shares of Class A common stock of Tiptree for aggregate consideration of $7.3M from Nomura Securities Co., Ltd. The transaction is expected to be accretive to both book value and earnings per share on a GAAP basis. The shares acquired will be held as treasury shares and will not be outstanding for accounting or voting purposes.
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PFBC | Hot Stocks16:01 EDT Preferred Bank raises quarterly dividend 11% to 20c per share - Preferred Bank reported that the board of directors has declared a quarterly cash dividend of 20c per share, representing an increase of 2c or 11% over the previous quarterly dividend of 18c per share. The dividend is payable on July 21, 2017 to holders of record on July 7, 2017.
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AMGN | Hot Stocks16:01 EDT Amgen receives positive CHMP opinion to expand use of Mimpara - Amgen announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion for the Marketing Authorization of a pediatric formulation of Mimpara. Approval was recommended for the treatment of secondary hyperparathyroidism in children aged three years and older with end-stage renal disease on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy. The Marketing Authorization Application for Mimpara was based on studies Amgen began in 2007 to assess the use of Mimpara in pediatric secondary HPT patients, who have very few treatment options.
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EZPW | Hot Stocks15:22 EDT Rovida Advisors reports 5.1% passive stake in EZCORP
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DAL | Hot Stocks15:03 EDT Delta Air Lines, Korean Air create leading trans-Pacific joint venture - Delta Air Lines and Korean Air have reached an agreement to create a leading trans-Pacific joint venture in both scope and service, offering an enhanced and expanded network, industry-leading products and service and a seamless customer experience between the U.S. and Asia. The agreement, signed today, deepens their historic partnership, which spans nearly two decades. The agreement is the latest expansion of the longstanding partnership between Delta and Korean Air, which began in 2000 when both carriers became co-founders of the SkyTeam global airline alliance. This agreement follows the airlines' signing of a memorandum of understanding in March announcing the intention to form a joint venture. The joint venture will create a combined network serving more than 290 destinations in the Americas and more than 80 in Asia, providing customers of both airlines with more travel choices than ever before. The joint venture will augment the two airlines' capabilities in the trans-Pacific market and provide the necessary scale and scope to compete in this market. Delta and Korean Air will lay the groundwork for implementing all aspects of the joint venture, subject to regulatory approvals, including: Expanded codesharing in the trans-Pacific market; Joint sales and marketing initiatives in Asia and the United States; Colocation at key hubs with seamless passenger and baggage transit experience; Enhanced frequent flyer benefits, providing customers of both airlines the ability to earn and redeem miles on Delta's SkyMiles and Korean Air's SKYPASS programs; Increased belly cargo cooperation across the trans-Pacific. Under the agreement, the airlines will also share costs and revenues on flights within the scope of the joint venture as they work to expand service options for travelers. In anticipation of the joint venture, Delta recently launched new nonstop service between Atlanta and Seoul. This flight complements Korean Air's existing service and provides customers in the U.S. with greater access to destinations across Asia. At the same time Korean Air will continue to expand its U.S. - Korea network in summer 2017 with the introduction of a third roundtrip flight between Los Angeles and Seoul, as well as a second flight between San Francisco and Seoul.
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LION | Hot Stocks14:46 EDT Fidelity Southern announces appointment of Charles Christy as CFO - Fidelity Southern announced the appointment of Charles Christy as Executive VP and Chief Financial Officer of the company and of its subsidiary, Fidelity Bank, effective June 26. Christy joins Fidelity Southern from CoastalSouth Bancshares, where he was the Executive VP and CFO for the past seven years. Current CFO Stephen Brolly will continue to serve the company as an officer in Fidelity Southern and Fidelity Bank.
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SAFM | Hot Stocks14:08 EDT Sanderson Farms to 'vigorously defend' California chicken lawsuit - Sanderson Farms issued a statement following its reading of a complaint filed on June 22, 2017, in the United States District Court for the Northern District of California. In the complaint, three non-profit corporations allege, among other things, that the company's products contain residues of human and animal antibiotics, other pharmaceuticals, hormones, steroids and pesticides. They seek, among other things, an order enjoining the company from continuing its "100% Natural" marketing program. "Sanderson Farms generally does not comment on pending litigation, but the allegations in this lawsuit bear upon food quality and safety," the company said. "The company unequivocally states it does not administer the antibiotics, other chemicals and pesticides, or "other pharmaceuticals" listed in the complaint to its flocks, with one exception. To suggest otherwise is false and irresponsible. company veterinarians do, on rare occasions, prescribe penicillin to treat sick poultry flocks when in their professional judgement they consider it necessary for animal welfare. Such medicines are given in accordance with Food and Drug Administration guidance, including a withdrawal period between the time the medicine is administered and when the flock is harvested. Most all of the other drugs and chemicals cited in the complaint are not approved for use in chickens, and some would be lethal to chickens. In its 70-year history, Sanderson Farms has never been cited by the United States Department of Agriculture or any other regulatory body for violation of any residue law, rule or regulation. Sanderson Farms will vigorously defend this lawsuit. The company also intends to continue its marketing and advertising campaign to educate consumers on its position regarding the judicious use of FDA-approved medicines to treat sick chickens and to prevent disease in chicken flocks. Such use is consistent with Sanderson Farms' animal welfare obligations to the animals under its care, its environmental sustainability efforts and the company's obligations regarding food safety."
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PTLA | Hot Stocks13:36 EDT Portola Pharmaceuticals resumes, jumps 44% after Bevyxxa approval
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PTLA | Hot Stocks13:35 EDT Portola Pharmaceuticals trading resumes
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PTLA | Hot Stocks13:26 EDT Portola Pharmaceuticals to resume trading at 1:35 pm ET - Portola Pharmaceuticals is scheduled to resume trading at 1:35 pm ET, with quotation to resume at 1:30 pm ET, according to Nasdaq.
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CLLS | Hot Stocks13:15 EDT Cellectis trading resumes
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INFY | Hot Stocks13:13 EDT Infosys says 'committed no wrongdoing, denies all allegations' in NY tax matter - Infosys issued the following statement: "Infosys' agreement concludes the State of New York's investigation relating to the amount of taxes the company paid in 2010-2011 without any criminal or civil charges being filed. While this investigation centered on alleged paperwork errors, the company committed no wrongdoing and denies all allegations made in this regard. This settlement relates to legal issues already resolved under the 2013 settlement with the US Department of Justice, and was reached by both parties to avoid protracted litigation. Infosys maintains robust policies and procedures to ensure adherence with all applicable regulations and laws. Infosys will continue to focus on boosting American innovation, hiring American workers and better serving our valued customers across the United States."
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CLLS | Hot Stocks13:08 EDT Cellectis to resume trading at 1:15 pm ET - Cellectis is scheduled to resume trading at 1:15 pm ET, with quotation to resume at 1:10 pm ET, according to Nasdaq.
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PTLA | Hot Stocks13:06 EDT Portola Pharmaceuticals announces FDA approval of Bevyxxa - Portola Pharmaceuticals announced the U.S. Food and Drug Administration has approved Bevyxxa, which it said is "the first and only" anticoagulant for hospital and extended duration prophylaxis of venous thromboembolism, or VTE, in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. The timeline on which Portola expects to launch Bevyxxa is between August and November 2017. During this period, Portola will complete salesforce hiring and training, drug manufacturing validation and inventory buildup, the company said.
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BHI | Hot Stocks13:03 EDT Baker Hughes reports U.S. rig count up 8 to 941 rigs - Baker Hughes reports that the U.S. rig count is up 8 rigs from last week to 941, with oil rigs up 11 to 758, gas rigs down 3 to 183. The U.S. Rig Count is up 520 rigs from last year's count of 421, with oil rigs up 428, gas rigs up 93, and miscellaneous rigs down 1 to 0. The U.S. Offshore Rig Count is unchanged from last week at 22 and up 1 rig year over year. The Canadian Rig Count is up 11 rigs from last week to 170, with oil rigs up 7 to 98 and gas rigs up 4 to 72. The Canadian Rig Count is up 94 rigs from last year's count of 76, with oil rigs up 62, gas rigs up 33, and miscellaneous rigs down 1 to 0.
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RIO GLNCY | Hot Stocks12:59 EDT Rio Tinto to give new Glencore C&A proposal 'appropriate consideration' - Rio Tinto (RIO) acknowledges that it has today received a revised proposal from Glencore plc (GLNCY) to acquire Rio Tinto's wholly-owned Australian subsidiary, Coal & Allied Industries Limited. "The Rio Tinto board will give the new proposal appropriate consideration and will provide a further update in advance of the general meeting of Rio Tinto plc to be held in London at 11am on Tuesday 27 June 2017. If Glencore's revised proposal is deemed to be a superior proposal under the terms of the sale and purchase agreement with Yancoal and the Rio Tinto board decides the revised proposal is in the best interests of shareholders, then the Rio Tinto board intends to adjourn the general meeting of Rio Tinto plc. The matching rights process, pursuant to which Yancoal will have two business days to present a counter offer, would then be implemented. If the Rio Tinto board decides to reject Glencore's revised proposal, then the general meeting of Rio Tinto plc is expected to proceed as currently scheduled. In the event that the Rio Tinto board requires additional time to give the Glencore proposal appropriate consideration then the Rio Tinto board may adjourn the general meetings of Rio Tinto plc and Rio Tinto Limited," the company said.
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CLLS | Hot Stocks12:56 EDT Cellectis announces Calyxt filing of registration statement for proposed IPO - Cellectis S.A. announced that Calyxt has publicly filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission relating to a proposed initial public offering of shares of Calyxt common stock. Calyxt is Cellectis' 100% owned gene editing agriculture company. The number of shares to be offered and the price range for the offering have not yet been determined, although Cellectis intends to retain majority ownership of Calyxt. Citigroup, Credit Suisse and Jefferies are acting as joint book-running managers for the proposed offering.
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PTLA | Hot Stocks12:33 EDT Portola FDA label cites secondary endpoint instead of Cohort 1 data, tweet says - Twitter user @AndyBiotech, a biotech investor, points out in a tweet that "$PTLA FDA label only cites the overall population data (secondary endpt) instead of Cohort 1 data (primary endpt)." Reference Link
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CZR CACQ | Hot Stocks12:29 EDT Caesars announces effectiveness of S-4 registration statement related to merger - Caesars Entertainment Corporation (CZR) and Caesars Acquisition Company (CACQ) announced that the SEC has declared effective the Registration Statement on Form S-4 previously filed by Caesars Entertainment on March 13, 2017, and amended on June 5, 2017 and June 20, 2017, in connection with the Amended and Restated Agreement and Plan of Merger dated as of July 9, 2016 and amended on February 20, 2017, pursuant to which, among other things, Caesars Acquisition will merge with and into Caesars Entertainment. Caesars Entertainment and Caesars Acquisition also announced today that they have individually scheduled special meetings of Caesars Entertainment and Caesars Acquisition stockholders in connection with the pending Merger. Stockholder approval of the Merger is a critical step to concluding the restructuring of Caesars Entertainment Operating Company. The special meeting of Caesars Entertainment stockholders will be held on July 25, 2017, at 8:00 a.m. PT in the Classico Chapel, Caesars Palace, One Caesars Palace Drive, Las Vegas, Nevada. All Caesars Entertainment stockholders of record as of the close of business on June 19, 2017 will be entitled to vote their shares of Caesars Entertainment common stock at the special meeting. The special meeting of Caesars Acquisition stockholders will be held on July 25, 2017, at 10:00 a.m. PT in the Classico Chapel, Caesars Palace, One Caesars Palace Drive, Las Vegas, Nevada. All Caesars Acquisition stockholders of record as of the close of business on June 19, 2017 will be entitled to vote their shares of Caesars Acquisition common stock at the special meeting.
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GOOG GOOGL | Hot Stocks12:28 EDT Google to bring Posts service to local businesses - Alphabet's Google said in a blog post that Google My Business is bringing Posts to local businesses. "With Posts, you can share timely, relevant updates right on Google Search and Maps to help your business stand out to potential customers," Google said in its blog. "And by including custom calls-to-action directly on your business listing, you can choose how to connect with your customers." Reference Link
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NVS | Hot Stocks12:04 EDT Novartis publishes full results of Phase III RATIFY clinical trial in NEJM - Novartis announced that full results from the Rydapt Phase III RATIFY clinical trial were published in The New England Journal of Medicine, or NEJM. Top-line data from this study were previously presented during the plenary session at the American Society of Hematology, or ASH, Annual Meeting in 2015. New data include disease-free survival, or DFS, further analysis of patients undergoing transplant and expanded safety information. "The data from the CALGB 10603/RATIFY trial reinforce the efficacy and safety of Rydapt in patients with FLT3-mutated AML and set the stage for a shift in the way the medical community can approach this difficult-to-treat disease," said Richard Stone, MD, Chief of Staff and Director of the Adult Leukemia Program at Dana-Farber Cancer Institute, and Alliance for Clinical Trials in Oncology study chair for the RATIFY trial. "This study has provided critical insights for the AML community and shows the potential of clinical research carried out by international investigators with support from both public and private sources."
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IGLD | Hot Stocks11:59 EDT Internet Gold trading resumes
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PTLA | Hot Stocks11:56 EDT Portola Pharmaceuticals betrixaban approved by FDA - The NDA for Portola Pharmaceuticals' betrixaban has been approved by FDA, according to a post on the agency's website. The stock remains halted for trading, pending news. Reference Link
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IGLD | Hot Stocks11:54 EDT Internet Gold trading halted, volatility trading pause
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CLLS | Hot Stocks11:45 EDT Cellectis trading halted, news pending
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INFY | Hot Stocks11:34 EDT Infosys reports auditors found no evidence of wrongdoing - Infosys announced earlier that its audit committee's appointed auditors have completed their "detailed and extensive" independent investigation of anonymous complaints that made allegations relating to the company. The auditors "did not find any evidence whatsoever of wrongdoing," the company stated. Also, the company said it has fully cooperated with all requests for information from SEBI regarding the anonymous complaints.
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INFY | Hot Stocks11:31 EDT NY AG Schneiderman announces $1M settlement with Infosys - New York Attorney General Eric T. Schneiderman announced a $1M settlement with Infosys Corporation, a global outsourcing and consulting company, that failed to properly compensate hundreds of workers and to pay applicable taxes, by systematically abusing the United States visa rules in placing foreign workers at client sites in New York State. Infosys Corporation has a significant presence in New York State and provides consulting and outsourcing services to many New York-based clients in the financial sector, among other industries. The settlement resolves whistleblower claims that Infosys Corporation, in the course of providing outsourcing services, routinely brought foreign IT personnel into New York to perform work in violation of the terms of their visas.
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PTLA | Hot Stocks11:18 EDT Portola Pharmaceuticals trading halted, news pending
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NURO | Hot Stocks11:08 EDT NeuroMetrix provides update on Quell wearable pain relief clinical program - NeuroMetrix provided an update on its Quell clinical program. The objective of the clinical program is to build clinical credibility for Quell technology, further scientific understanding of its mechanism of action, and better identify Quell therapy responders. There are currently 4 studies underway. Quell TENS band for Chemotherapy-Induced Peripheral Neuropathy. A Feasibility Study. University of Rochester Medical Center, University of Rochester, Rochester, NY: This open label study is evaluating Quell efficacy, assessed by pain relief and continued device use, in subjects with CIPN. Preliminary results were presented at the recent American Pain Society meeting May 17-20 in Pittsburgh, PA. Among subjects completing the first 6 weeks of the study, 73% decided to continue using their Quell device. In addition, statistically significant reductions in pain, tingling, cramping and numbness were observed. Quell Opioid Reduction and Pain Relief in Patients with Cancer. Scripps Translational Science Institute, Scripps Health, San Diego, CA: This randomized sham-controlled study is evaluating opioid use reduction in patients with various forms of cancer pain. The study is fully enrolled. Preliminary results are expected in Q4 '17. Efficacy of the Quell Wearable Device for Chronic Low Back Pain. Brigham and Women's Hospital, Harvard Medical School, Boston, MA: This randomized controlled study is evaluating pain relief and quality of life improvements in subjects with low back pain using Quell compared to control subjects on standard therapy. The study is 75% enrolled. Preliminary results are expected in Q4 '17. Prospective Validation of Quell Sleep/Wake Classification and Periodic Leg Movement Detection. Massachusetts General Hospital, Harvard Medical School, Boston, MA: This study is comparing Quell sleep tracking to gold standard polysomnography. The study is 25% enrolled. Preliminary results are expected in Q4 '17.
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CAT | Hot Stocks11:08 EDT As bar gets raised Deutsche Bank gets less bullish on Caterpillar - Deutsche Bank downgraded Caterpillar (CAT) to Hold from Buy, saying that a mining recovery is already anticipated by investors while the outlook for the company's energy business has become less certain. MINING RECOVERY REFLECTED: The recovery in Caterpillar's mining aftermarket business is already widely expected by investors and reflected in the stock, wrote Deutsche Bank analyst Nicole DeBlase. Moreover, after rising significantly, analysts' consensus estimate now calls for Caterpillar's earnings per share to rise at a 23% compound annual growth rate, DeBlase reported. DeBlase noted that the consensus forecast is now in-line with her own outlook. ENERGY WEAKNESS: Previously, DeBlase had expected Caterpillar's oil and gas unit to enable the company's overall EPS to beat expectations, she wrote. However, the recent downturn in energy prices has made her less sure of that view, she stated. LAST 'BEAT AND RAISE' IN 2017: DeBlase believes that Q2 will be the "last significant beat and raise" report that Caterpillar will deliver in 2017. DeBlase lowered her price target on the shares to $106 from $121. PRICE ACTION: In morning trading ,Caterpillar was fractionally lower at $103.48.
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HZNP | Hot Stocks11:02 EDT Horizon Pharma completes sale of European marketing rights for Procysbi - Horizon Pharma announced that it has completed the sale of a European subsidiary that owns the marketing rights to PROCYSBI delayed-release capsules and QUINSAIR in Europe, the Middle East and Africa regions to Chiesi Farmaceutici for an upfront payment of $72.2M, with additional potential milestone payments based on sales targets. Horizon will maintain control of manufacturing supply in the EMEA regions through its third party supplier. In addition, Horizon will maintain marketing rights for PROCYSBI and QUINSAIR in the United States, Canada and Latin America. The divested subsidiary has facilities in the Netherlands, France and Germany and has approximately 40 employees. As previously announced, Horizon anticipates the divestiture to result in a reduction of full-year 2017 net sales by approximately $15M related to PROCYSBI and QUINSAIR in the EMEA region, with a neutral impact to its full-year 2017 adjusted EBITDA. Accordingly, the company's full-year 2017 net sales are now expected to be in a range of $985M-$1.02B. Horizon's full-year 2017 adjusted EBITDA guidance range of $315M-$350M has not changed.
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NVO | Hot Stocks10:52 EDT Novo Nordisk reports up to 13.8% weight loss in people receiving semaglutide - Novo Nordisk announced the headline results from a 52-week double-blind phase 2 clinical trial with once-daily subcutaneous semaglutide investigating safety and potential for inducing and maintaining weight loss in people with obesity. In the trial, 957 people with obesity were randomised to treatment with doses of semaglutide between 0.05 to 0.4 mg/day or placebo. Liraglutide 3.0 mg/day was included for comparison. Approximately 100 people were included in each active treatment arm in combination with diet and exercise. All people in the trial were treated for 52 weeks followed by a 7-week follow-up period. From a mean baseline weight of around 111 kg and a body mass index of approximately 39 kg/m(2), a weight loss up to 17.8 kg was observed after 52 weeks of treatment with semaglutide. This corresponded to an estimated 13.8% weight loss compared to the weight loss of 2.3% achieved by diet, exercise and placebo alone, with all treatment arms adjusted for people discontinuing treatment in the study. The results from the liraglutide 3.0 mg treatment arm were broadly in line with previously reported data.
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SNCR | Hot Stocks10:31 EDT Synchronoss confirms receipt of Siris Capital indication of interest - Synchronoss Technologies confirmed that it has received a non-binding indication of interest from Siris Capital Group to acquire all of the outstanding shares of the company's common stock for $18.00 per share in cash, subject to certain conditions. The company's Board of Directors, consistent with its fiduciary duties, will carefully review and consider Siris's indication of interest and pursue the course of action that it believes is in the best interests of the company and its shareholders, Synchronoss stated.
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SYY... | Hot Stocks10:27 EDT JPMorgan sees food distributors facing competition from Amazon - Noting that Amazon's (AMZN) acquisition of Whole Foods (WFM) has shown that it's open to expensive, "transformative" acquisitions, JPMorgan believes that there is a greater chance that the e-commerce behemoth will disrupt the business models of food service distributors. As a result, the firm removed food distributor Sysco (SYY) from its Analyst Focus List. AMAZON'S INDEPENDENT RESTAURANT OPPORTUNITY: There is now a greater chance that Amazon will begin looking to deliver food to independent restaurants, either by building such a business on its own or by making an acquisition, wrote JPMorgan analysts John Ivankoe and Alex Morgard. Such a move would be "logical" for the e-commerce giant, wrote the analysts, who noted that independent restaurants "buy larger pack sizes, demand larger delivery sizes, and are highly repetitive in terms of what they buy." Independent restaurants will appreciate Amazon's "digital engagement," and "price transparency," as well as its ability to customize offers based on the restaurants ordering habits, Ivankoe and Morgard believe. Moreover, Amazon already delivers prepared restaurant food to consumers through its Amazon Now offering, they noted. DISTRIBUTORS' EXPOSURE: Sysco has approximately 40% exposure to independent restaurants, while US Foods (USFD) has exposure of about 30% and Performance Food Group (PFGC) has about 26% exposure, the analyst stated. However, the independent restaurants probably contribute a higher proportion of the companies' operating income, given the restaurants' "favorable economics," according to Ivankoe and Morgard. PRICE ACTION: In morning trading, Sysco fell 4.7% to $50.30, Performance Food retreated 5% to $25.90, and US Foods slumped 5.6% to $26.05.
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UPS | Hot Stocks10:02 EDT UPS moves higher amid activist investor speculation - Early strength in shares of UPS coincided with traders circulating chatter of the potential involvement of an activist investor, according to industry contacts. The Fly, in fulfilling its mission of explaining stock movement, often comes across the many unconfirmed rumors being passed through trading desks and social media platforms. On the occasion that rumors or speculation appear on The Fly's news feed, it should be viewed not as giving credence to the conjecture, rather as simply highlighting its impact on the stock prices of the companies involved. Shares of UPS are up 95c, or about 1%, $110 in early trading.
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STT BK | Hot Stocks10:01 EDT State Street appoints Steve Cook as SVP for U.S. Investment Services unit - State Street (STT) has appointed Steve Cook, an Exchange Trade Fund industry expert, and mutual fund industry veteran to serve as senior vice president within its US Investment Services business. Cook joined State Street in late April reporting to Tom Forrester, senior vice president for State Street's Investors Services Americas team. Cook will oversee a broad range of relationships with clients operating diverse fund structures in the US and globally. He previously spent 20 years at BNY Mellon (BK), serving most recently as head of structured products services business, which comprised the firm's ETF business globally and the Unit Investment Trust and Closed End Funds services business in the US.
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DDAIF... | Hot Stocks09:50 EDT EU commercial vehicle registrations up 9% in May - In May, EU commercial vehicle demand recovered after April's decline. In total 204,770 vehicles were registered, 9% more than in the same month last year. Registrations grew across all segments, from vans to trucks and buses. All major EU markets performed well, apart from the United Kingdom, which posted a modest decline of 2.6%. Spain and Germany saw the highest percentage gains at 19.3% and 13.2% respectively, followed by the Italian markets at 9.2% and French markets at 7.9%. markets. Truck makers and suppliers include Daimler AG (DDAIF), Paccar (PCAR), CNH Industrial (CNHI), Navistar (NAV), Cummins (CMI) and Allison Transmission (ALSN).
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IFF | Hot Stocks09:41 EDT International Flavors to settle trade secret lawsuit with ZoomEssence for $56M - ZoomEssence and International Flavors & Fragrances have settled all claims and counterclaims brought in a lawsuit that was originally filed by ZoomEssence on March 9, 2012, in the United States District Court for the District of New Jersey. Under the settlement, IFF will make a one-time payment of $56M to ZoomEssence. The Settlement Agreement provides for the dismissal of all claims, with prejudice and without any admission of liability or wrongful conduct, and full mutual releases.
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STML | Hot Stocks09:39 EDT Stemline presents updated stage 1 and 2 data from SL-401 trial - Stemline Therapeutics announced the presentation of updated clinical data from Stages 1 and 2 of the ongoing SL-401 pivotal Phase 2 clinical trial in blastic plasmacytoid dendritic cell neoplasm, along with safety data from the entire SL-401 clinical program, at the 22nd Congress of the European Hematology Association. The overall response rate for Stage 1 and 2 BPDCN patients was 84%, with a complete response rate of 59%, by investigator-assessment. Eight BPDCN patients who achieved remission on SL-401 were subsequently bridged to stem cell transplant, including one relapsed/refractory patient. In first-line BPDCN patients treated at 12 ug/kg/day, the median overall survival has not been reached. Stage 3 is fully enrolled and data will be reported, along with further updated Stage 1 and 2 data, in 2H17. The company said: "Depending on the results of this ongoing Phase 2 trial, the largest prospective study ever conducted in this indication, we intend to file a BLA for SL-401 in BPDCN in 4Q17/1Q18."
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REGN | Hot Stocks09:36 EDT Regeneron down 4.6% to $502.22 in early trading
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ADHD... | Hot Stocks09:29 EDT On The Fly: Pre-market Movers - HIGHER: Alcobra (ADHD), up 4.5% after retaining a strategic financial advisor... AVEO (AVEO), up 53.9% after reporting CHMP recommended Fotivda as a RCC treatment... Synchronoss (SNCR), up 35.5% after Siris Capital offers to acquire company for $18.00 per share. DOWN AFTER EARNINGS: BlackBerry (BBRY), down 7%... Bed Bath & Beyond (BBBY), down 10.7%. ALSO LOWER: Bellicum Pharmaceuticals (BLCM), down 5.5% after presenting updated results from its BP-004 study... bluebird bio (BLUE), down 6.8% after presenting new data from HGB-205 study of LentiGlobin drug product.
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RIO GLNCY | Hot Stocks09:29 EDT Glencore raises offer for Rio Tinto's Coal & Allied to $2.675B plus royalties - Glencore (GLNCY) announced that it has submitted an improved irrevocable binding offer to acquire Rio Tinto's (RIO) 100% interest in Coal & Allied Industries Limited for $2.675B cash plus a coal price linked royalty. All cash is payable in full immediately upon completion. Glencore's offer is at least $225M greater than Yancoal's proposal, the company stated. The Glencore offer remains conditional only on approval from China, Korea, Taiwan and Australia. Japanese regulatory approval to acquire C&A has already been obtained. "Demonstrating our confidence in securing all approvals, Glencore's Offer is supported by a $225M deposit which will be forfeited if the transaction does not complete as a result of a failure to obtain a regulatory approval...Glencore believes that it will obtain all regulatory approvals in a timely manner and that its offer fully compensates Rio Tinto for any potential delays beyond Yancoal's expected completion date as announced by Rio Tinto," the company said.
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RHHBY | Hot Stocks09:22 EDT Roche receives FDA approval for Elecsys HIV combi PT assay - Roche announced that its fourth-generation HIV combination antigen-antibody assay, the Elecsys HIV combi PT assay, has received FDA PMA approval from the U.S. FDA.
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HUM COF | Hot Stocks09:19 EDT Humana appoints Sam Deshpande as CRO - Humana (HUM) has named Sam Deshpande to the newly created position of senior VP and CRO to oversee development of the company's Chief Risk Office. In this new, executive-level role, Deshpande will report directly to Humana president and CEO Bruce Broussard, and will serve as a member of Humana's Management Team. Deshpande will set direction and establish policy in the areas of enterprise risk management and compliance, while building a risk strategy and a culture that manages risk appropriately. Deshpande joins Humana from Capital One (COF), most recently as business CRO for the U.S. and international card business.
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DHI FOR | Hot Stocks09:13 EDT D.R. Horton confirms increased offer to acquire 75% of Forestar - D.R. Horton (DHI) announced an increased offer to acquire 75% of the currently outstanding shares of Forestar Group (FOR) for $17.75 per share in cash. In a press release earlier, the Forestar board of directors said it had deemed the D.R. Horton offer a "Superior Proposal" to the amended agreement between Forestar and Starwood Capital Group. Donald Horton, chairman of the board, said, "We are pleased that the Forestar Board has determined that our revised offer constitutes a 'Superior Proposal,' and we look forward to completing this transaction as quickly as possible in the best interests of the Forestar and D.R. Horton shareholders. This transaction advances D.R. Horton's strategy of increasing our access to high-quality optioned land and lot positions and will allow us to significantly accelerate Forestar's growth into a leading national land developer. Forestar's shareholders will receive superior and immediate cash value, along with the opportunity to participate in significant value creation over the long term. This strategic alignment will enable both companies to enhance their operational efficiency and returns."
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FINL | Hot Stocks09:07 EDT Finish Line: 'General malaise in retail right now'
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FINL | Hot Stocks09:04 EDT Finish Line: Retail today 'challenging' across multiple industries
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BID | Hot Stocks09:04 EDT Sotheby's June sales of Impressionist & Modern Art in London total $200.8M - Sotheby's June 2017 sales of Impressionist & Modern Art in London achieved $200.8M, exceeding their overall low estimate of $178.7M and representing a nearly 11% increase in Dollars and a 29% increase in Pounds on the same sales one year ago.
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IBM | Hot Stocks09:02 EDT IBM, AFRL collaborate on AI supercomputing system - IBM and the U.S. Air Force Research Laboratory announced they are collaborating on a first-of-a-kind brain-inspired supercomputing system powered by a 64-chip array of the IBM TrueNorth Neurosynaptic System. The scalable platform IBM is building for AFRL will feature an end-to-end software ecosystem designed to enable deep neural-network learning and information discovery. The system's advanced pattern recognition and sensory processing power will be the equivalent of 64M neurons and 16B synapses, while the processor component will consume the energy equivalent of a dim light bulb - a mere 10 watts to power.
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FINL | Hot Stocks09:02 EDT Finish Line: Traffic 'challenged' in Q1, particularly in May - Says traffic "challenged" in Q1, particularly in May, both online and in store.
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KDMN | Hot Stocks09:01 EDT Kadmon to present interim data on KD025 in cGVHD at R&D day - Kadmon Holdings will present interim data from its ongoing Phase 2 clinical trial of KD025, the company's lead ROCK2 inhibitor, in previously treated patients with chronic graft-versus-host disease. The data will be presented at Kadmon's Research and Development Day in New York City on Tuesday, July 11, 2017, from 8:45 a.m. to 11:00 a.m. ET. The R&D Day will feature presentations by key opinion leaders, including Bruce Blazar, M.D., Regents Professor in the Department of Pediatrics, Chief of the Pediatric Blood and Marrow Transplantation Program and Vice Dean for Clinical Investigation at the School of Medicine at the University of Minnesota, Minneapolis, MN. Dr. Blazar will share the findings of his preclinical research on KD025 in cGVHD. Also presenting is Amandeep Salhotra, M.D., Assistant Professor, Hematology and Hematopoietic Cell Transplantation at City of Hope, Duarte, CA. Dr. Salhotra will present interim data from the first cohort of the ongoing cGVHD trial. Kadmon's executive management team, led by Harlan W. Waksal, M.D., President and Chief Executive Officer, will provide an update on KD025 as well as the Company's ROCK inhibitor platform. KD025 is being studied in three ongoing clinical trials in autoimmune and fibrotic diseases: A placebo-controlled Phase 2 clinical trial in moderate to severe psoriasis, an open-label Phase 2 clinical trial in idiopathic pulmonary fibrosis and an open-label Phase 2 clinical trial in cGVHD.
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EXPE | Hot Stocks09:01 EDT Expedia completes acquisition of majority stake in SilverRail - Expedia and SilverRail Technologies announced that Expedia has completed its acquisition of a majority stake in SilverRail. The acquisition builds on the partnership the two companies have had since 2010 when Egencia, Expedia's corporate travel brand, began using SilverRail's expertise to offer rail inventory in the U.S. The partnership expanded in 2016 when Expedia.com announced it would use SilverRail's technology platform to sell rail tickets through the Expedia.co.uk website. The acquisition broadens Expedia's breadth of choice of travel products across air, hotel, car rental, cruise, packages and rail through SilverRail's technology, bringing rail supply online to a global audience.
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BBRY | Hot Stocks08:55 EDT BlackBerry says most software growth will come in 2H
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FINL M | Hot Stocks08:54 EDT Finish Line sees 2H comps up low single digits - Finish Line (FINL) sees improved comp trends, particularly in 2H. Says expects to have 69 updated stores for upcoming back-to-school season. Says will open a "handful" of standalone kid's shops later this year. Says Macy's (M) on track to hit high end of long-term goal of annual sales of $350M in sales for FY18, ahead of original timetable. Says comps fell 2.8% in March, up 4.2% in April, down 11.8% in May. Plans to close 15-20 stores in FY18, remodel 45-60. Expects Macy's business to generate $345M-$355M in sales for FY18, with HSD operating margin. Sees Q2 gross margins down y/y, similar to decline experienced in Q1. Sees 2H comps up low single digits. Finish Line is now down 4% in premarket trading.
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FINL | Hot Stocks08:52 EDT Finish Line: Comp trends have returned to positive territory in June
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FINL | Hot Stocks08:51 EDT Finish Line says comps fell 11.8% in May
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BBRY | Hot Stocks08:51 EDT BlackBerry says sees more growth in sales/marketing vs. R&D - Says starting to be "more aggressive" with marketing. Says needs to "ramp up" distribution channels.
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IFF | Hot Stocks08:49 EDT International Flavors, ZoomEssence announce lawsuit settlement - International Flavors & Fragrances and ZoomEssence have mutually agreed to settle all claims and counterclaims brought in a lawsuit in the United States District Court for the District of New Jersey. The parties agreed to dismiss their claims against one another, with prejudice and without any admission of liability or wrongful conduct, to avoid any further expense and disruption from the litigation. Under the settlement agreement, IFF will make a one-time payment to ZoomEssence of $56M and the parties will exchange full mutual releases.
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ABBV | Hot Stocks08:49 EDT AbbVie receives CHMP positive opinion for MAVIRET - AbbVie announced that the European Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion recommending marketing authorization of MAVIRET, an investigational, pan-genotypic treatment for adults with chronic hepatitis C virus infection. If approved, MAVIRET will be a once-daily, ribavirin-free, 8-week option for patients without cirrhosis and who are new to treatment across all genotypes, who comprise the majority of people living with HCV.1 The European Commission will now review the CHMP opinion and a final decision is expected in Q3 2017.
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FOR DHI | Hot Stocks08:41 EDT Forestar board designates revised D.R. Horton proposal as 'Superior Proposal' - Forestar Group (FOR) announced that it had received a revised binding proposal from D.R. Horton (DHI) to acquire 75% of the outstanding shares of Forestar common stock for $17.75 per share in cash and that its board of directors, after consultation with its outside legal and financial advisors, has unanimously determined that the revised proposal constitutes a "Superior Proposal," as defined in Forestar's amended merger agreement with Starwood Capital Group. Under the terms of D.R. Horton's revised proposal, which contains definitive documentation, D.R. Horton would acquire 75% of the outstanding shares of Forestar common stock for $17.75 per share in cash and Forestar and D.R. Horton would enter into a master supply agreement establishing a strategic relationship between Forestar and D.R. Horton for the supply of developed lots and a stockholder's agreement. On June 23, Forestar notified Starwood that Forestar had received the revised binding proposal from D.R. Horton and that Forestar's board of directors has determined that D.R. Horton's revised proposal constitutes a "Superior Proposal" and that Forestar's board of directors intends to terminate the amended merger agreement with Starwood to enter into a definitive, written agreement with respect to D.R. Horton's revised proposal. In accordance with the amended merger agreement with Starwood, Forestar will discuss and negotiate with Starwood in good faith until the end of the business day on June 28, such adjustments in the terms and conditions of the merger agreement with Starwood as would permit the Forestar board of directors not to terminate the amended merger agreement with Starwood. Subject to limited exceptions, D.R. Horton's revised offer is irrevocable until 1:00 p.m. on June 30. Forestar also announced that it has also entered into a second amendment to its merger agreement with Starwood to increase the merger consideration to $16.00 per share in cash. All other terms and conditions in the Starwood merger agreement remain unchanged. Forestar remains subject to the amended merger agreement with Starwood. Forestar's board of directors is not modifying, withdrawing, amending or qualifying its recommendation in favor of the amended merger agreement with Starwood and the merger contemplated thereby, or proposing to do so, and is not making any recommendation with respect to the revised D.R. Horton proposal.
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RARE | Hot Stocks08:39 EDT Ultragenyx provides regulatory update on burosumab - Ultragenyx Pharmaceutical announced that it has reached agreement with the FDA at a Pre-Biologics License Application, or pre-BLA, meeting on the clinical package to support the burosumab BLA filing for X-linked hypophosphatemia, or XLH. At the meeting, the FDA agreed that the BLA can be submitted based on available clinical data and confirmed that both pediatric and adult indications would be included in the review. Based on the agreement, the submission of the burosumab BLA is planned for the second half of 2017.
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MDWD | Hot Stocks08:38 EDT MediWound: BARDA gives Notice of Intent for 1st contract option to fund NexoBrid - MediWound announces that it received from the U.S. Biomedical Advanced Research and Development Authority, or BARDA, a written Notice of Intent to exercise an option to fund further research and development activities for expanding NexoBrid's indications. The BARDA contract advances the development and manufacturing, as well as the procurement of NexoBrid, MediWound's proprietary pharmaceutical product for enzymatic removal of eschar in deep-partial and full-thickness thermal burns, as a medical countermeasure for preparedness for mass casualty events. The five-year base contract signed in September 2015 includes $24M to support FDA approval of NexoBrid for use in thermal burn injuries as well as $16M for procurement of NexoBrid, which is contingent upon FDA Emergency Use Authorization and/or FDA marketing authorization for NexoBrid. In addition, the contract includes options for up to $22M for expanding NexoBrid's indications for which the Company received the Notice of Intent and an option of up to $50M for additional procurement. The total non-dilutive funding to MediWound under the BARDA contract is up to $112M.
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FINL | Hot Stocks08:36 EDT Finish Line says May comps were negative, sees comps improving in 2H - Says faced unanticipated pressure on sales, product margins late in quarter. Says May comps were negative. Sees "positive" comps for FY18, SSS improving in 2H. Says saw "nice pickup" in traffic in first few weeks of quarter, trends slowed in March. Says comps increased mid-single digits for April. Says had "several bright spots" in the quarter despite other disappointing trends. Comments taken from the Q1 earnings conference call. Finish Line is down 2.6% in premarket trading.
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ICE | Hot Stocks08:32 EDT IntercontinentalExchange executives to testify before Congress - Intercontinental Exchange announced that CFO Scott Hill will appear before the House Agriculture Committee on June 27 to discuss central clearing and systemic risk, and NYSE president Thomas Farley will appear before the House Financial Services Capital Markets Subcommittee to discuss equity market structure.
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BBRY | Hot Stocks08:31 EDT BlackBerry says 'comfortable' with IP position - Says no gaps in company's products. Says any M&A will focus on expanding markets, not products.
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BBRY | Hot Stocks08:23 EDT BlackBerry says expects positive free cash flow, EBITDA for FY18
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BLCM | Hot Stocks08:22 EDT Bellicum Pharmaceuticals presents updated results of BP-004 study - Bellicum Pharmaceuticals announced that results will be presented today from its global BP-004 clinical trial of BPX-501 in the Presidential Symposium at the 22nd Congress of the European Hematology Association. Investigators reported on pediatric patients with hematologic cancers and genetic blood diseases who underwent treatment with BPX-501 after an alpha/beta T-cell depleted haploidentical hematopoietic stem cell transplant and had at least six months of follow-up. Investigators reviewed overall data on 98 patients from 12 centers in the U.S. and Europe, as well as on the subset of 61 patients at European sites. At the 180-day measurement time point, cumulative incidence of transplant-related mortality was 5% in the overall patient population. A significant reduction in viral infections and reinfections was observed with BPX-501 compared to results from a study in Rome in patients undergoing an alpha/beta T-cell depleted haplo-HSCT without the addition of BPX-501. Additionally, there were no reported adverse events associated with the use of BPX-501 or rimiducid. At six months of follow-up, the cumulative incidence of Grade 2-4 acute Graft versus Host Disease was 13%. The cumulative incidence of chronic GvHD was 3% at one year of follow-up. The administration of rimiducid was required in 11 patients with acute GvHD who did not respond to standard treatments. In all 11 cases, rimiducid rapidly resolved the GvHD. In addition, the non-reactive T cells recovered, with no recurrence of GvHD. Rick Fair, President and CEO of Bellicum, said, "Data from our global BP-004 study continue to show consistent and strong overall outcomes across a wide range of diseases, suggesting the potential to enable curative stem cell transplants from partially matched donors for more children. Data from this ongoing BP-004 study in Europe, along with comparative data from an observational trial of pediatric patients undergoing a stem cell transplant from matched unrelated donors, are expected to support the filing of a European Marketing Authorization Application in mid-2018."
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BBRY | Hot Stocks08:20 EDT BlackBerry says continues to target gross margin of approximately 70% for FY18
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BBRY FDX | Hot Stocks08:14 EDT BlackBerry says FedEx will use radar vehicle-tracking product
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FENG | Hot Stocks08:12 EDT Phoenix New Media announces receipt of SAPPRFT notice - Phoenix New Media announced that it has received a public notice issued by the State Administration of Press, Publication, Radio, Film and Television of the People's Republic of China in connection with the Company's and certain other internet companies' regulatory non-compliances. The Notice requires the Company to suspend its ifeng video and audio services due to the lack of the internet audio-visual program transmission license and certain commentary programs that violates government regulations. Phoenix New Media will continue to take measures to strengthen content management, make sure all content are copyrighted and regulated, in order to continue the Company's video and audio operation. The Company will cooperate with SAPPRFT to make the necessary changes to its ifeng video and audio services. The Company is committed to complying with government regulation and continuing to improve the management and operation of the ifeng video and audio business. The Company believes that the daily operation of Phoenix New Media will not be impacted by this process. Phoenix New Media became aware that, due to its rapid growth, it did not implement sufficiently robust supervision of ifeng video and audio services, especially the we-media video content provided by users and other third-parties. The Company is making great efforts to eliminate the content in question and to strengthen management of the ifeng video and audio business. Going forward, Phoenix New Media will continue to strengthen cooperation with qualified media, such as CCTV and Xinhua News Agency, to ensure ifeng's healthy development and compliance. Meanwhile, the Company will continue to proactively fulfill its corporate social responsibility, enhance its self-regulation and welcome public supervision to provide further improved video and audio services for users.
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SYRS | Hot Stocks08:09 EDT Syros Pharmaceuticals presents preclinical data on SY-1425 - Syros Pharmaceuticals announced preclinical data on SY-1425, its first-in-class selective retinoic acid receptor alpha agonist currently in a Phase 2 clinical trial in genomically defined subsets of patients with acute myeloid leukemia and myelodysplastic syndrome, were presented at the European Hematology Association 22nd Congress in Madrid. Syros presented data showing that hypomethylating agents increase the activity of SY-1425 in in vitro and in vivo models of AML with high levels of RARA expression. HMAs including azacitidine, a therapy used as a standard-of-care in AML and MDS, prime the DNA for gene activation, thus enhancing SY-1425's gene activation and differentiation properties. In patient-derived xenograft models of AML with high RARA expression, SY-1425 in combination with azacitidine shows: greater clearance of tumor cells in bone marrow and other tissues, compared to either azacitidine or SY-1425 alone and greater duration of response, compared to either azacitidine or SY-1425 alone. Based on these data, Syros expanded its ongoing Phase 2 clinical trial to include an arm assessing the safety and efficacy of SY-1425 in combination with azacitidine in newly diagnosed AML patients 60 years or older who are not suitable candidates for standard chemotherapy and who are positive for the Company's biomarkers of high expression of the RARA-pathway associated genes RARA and IRF8. The treatment regimen for patients in the combination arm uses full doses of both agents and is consistent with the one identified in preclinical studies to maximize tumor suppression and tolerability. Syros presented data demonstrating that SY-1425 induces the cell surface protein CD38 in AML cells from patient samples with high levels of RARA expression. By inducing CD38, SY-1425 sensitizes the cells to daratumumab, an anti-CD38 monoclonal antibody that targets CD38-positive tumor cells for immune cell-mediated killing.Based on these data, Syros believes SY-1425 in combination with an anti-CD38 antibody represents a potentially promising immunotherapy approach for defined subsets of AML patients and plans to pursue clinical development of the combination in these patients. Syros presented data showing that SY-1425 regulates genes known to be associated with the proliferation of AML cells and normal myeloid differentiation. Using its proprietary gene control platform to analyze regulatory regions of the genome, Syros scientists identified changes in enhancer landscapes, gene expression and transcription factor distribution in AML cells treated with SY-1425. These changes show that SY-1425 pushes AML cells with high expression of the RARA and IRF8 genes into a more differentiated state. RARA and IRF8 code for transcription factors that work together to induce differentiation of blood and bone marrow cells and reduce proliferation of blast cells.
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BBRY | Hot Stocks08:09 EDT BlackBerry says won central bank of France as new customer - Says cyber security pipeline "growing nicely." Comments from Q1 earnings conference call.
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ALXN | Hot Stocks08:05 EDT Alexion announces positive CHMP opinion for Soliris - Alexion Pharmaceuticals announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion to extend the current therapeutic indication for Soliris to include the treatment of refractory generalized myasthenia gravis in patients who are anti-acetylcholine receptor antibody-positive. The final decision from the European Commission is anticipated in Q3. If approved, Soliris will be the first treatment available in the European Union for patients with refractory gMG who are anti-AChR antibody-positive, and the first and only complement inhibitor approved for this disease. The CHMP based its opinion on comprehensive clinical data from the Phase 3 REGAIN study and its long-term extension study. Soliris is approved in the U.S., EU, Japan and other countries for the treatment of patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, two ultra-rare, complement-mediated disorders. Alexion's supplemental Biologics License Application in the U.S. and a supplemental new drug application in Japan for Soliris as a treatment for patients with anti-AChR antibody-positive refractory gMG have been accepted for review by the U.S. Food and Drug Administration and the Japanese Ministry of Health, Labour and Welfare, respectively. Soliris has received Orphan Drug Designation for the treatment of patients with MG in the U.S. and EU, and for the treatment of patients with refractory gMG in Japan.
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AVEO | Hot Stocks08:03 EDT AVEO Oncology reports positive CHMP opinion for tivozanib as RCC treatment - AVEO Oncolog announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has recommended FOTIVDA for approval as a treatment for patients with advanced renal cell carcinoma. The CHMP's recommendation is now referred to the European Commission. The EC, which typically adheres to the recommendation of the CHMP, but is not obligated to do so, is expected to make its final decision in about 67 days. If approved by the EC, marketing authorization for tivozanib will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein. EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, is the European licensee for tivozanib. Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $394M in future research and development funding and milestone payments, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement's territories. Thirty percent of milestone and royalty payments received by AVEO, excluding research and development funding, are due to Kyowa Hakko Kirin as a sublicensing fee in Europe. In the United States, the royalty obligation to KHK ranges from the low- to mid-teens on net sales. AVEO says, ""If the European Commission grants marketing approval for tivozanib, it would trigger a $4 million research and development reimbursement payment from EUSA, and AVEO will also be eligible for up to $12M in additional milestones from EUSA based on member state reimbursement and regulatory approvals. These payments would add significant resources to our balance sheet as we work toward the anticipated readout of our U.S. pivotal trial in third-line RCC, the TIVO-3 trial, in the first quarter of 2018."
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ZAYO | Hot Stocks08:03 EDT Zayo Group selected by global webscale company for wavelength solution - A global webscale company has selected Zayo Group Holdings to implement a network to connect its data centers in Dublin and Amsterdam. The wavelength solution will be deployed on a direct route unique to Zayo, which bypasses the traffic clusters of London. The route, which leverages acquired assets from Geo Networks and Viatel, connects Dublin and continental Europe with a strategic fiber route.
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WSM | Hot Stocks08:02 EDT Williams-Sonoma to open expansive dual concept store in Seattle - Williams Sonoma announced that it will open its largest new concept store in Seattle on Saturday, June 24, featuring a contemporary look for the brand. The lifestyle store will include Williams Sonoma kitchen and food products, including a curated assortment of food from local businesses, as well as Williams Sonoma Home furnishings catering to the booming Seattle real estate market.
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PRFT | Hot Stocks08:01 EDT Perficient acquires Clarity Consulting in accretive deal - Perficient announced it has acquired Clarity Consulting, a Chicago-based $27M annual revenue consultancy with deep expertise in custom development, cloud implementations, and digital experience design on Microsoft platforms and devices. The acquisition is expected to be accretive to adjusted EPS immediately.
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NSAT | Hot Stocks08:01 EDT Norsat shareholders approve plan of arrangement with Hytera Communications - Norsat announced that at the adjourned 2017 annual general and special meeting of securityholders of Norsat held on June 22, securityholders of Norsat voted in favour of a special resolution to approve the plan of arrangement, pursuant to which Hytera Communications will acquire all the issued and outstanding shares of Norsat for $11.50 in United States dollars in cash per share by way of a court-approved plan of arrangement.
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CATB | Hot Stocks08:00 EDT Catabasis Pharmaceuticals to present results from MoveDMD trial at PPMD - Catabasis Pharmaceuticals announced that it will present data from Part A and Part B of the MoveDMD trial of edasalonexent -- CAT-1004 -- in an oral presentation at the upcoming 2017 Parent Project Muscular Dystrophy Annual Connect Conference to be held June 29 - July 2, 2017, in Chicago, IL, at the Chicago Marriott Downtown. Joanne Donovan, M.D., Ph.D., Chief Medical Officer of Catabasis, will deliver a presentation titled "MoveDMD: Phase 2 Trial of Edasalonexent, an NF-kB Inhibitor, in 4 to 7-Year Old Patients with Duchenne Muscular Dystrophy" on Friday, June 30, 2017, from 4:30pm - 4:45pm CT.
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BIIB SSNLF | Hot Stocks08:00 EDT Biogen's IMRALDI granted positive opinion by CHMP - The Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for IMRALDI, an adalimumab biosimilar candidate referencing Humira. The positive opinion will now be referred to the European Commission, which grants marketing authorization for medicines in the European Union. IMRALDI marks the third anti-TNF candidate to be submitted to the EMA by Samsung Bioepis, the joint venture between Samsung BioLogics (SSNLF) and Biogen (BIIB). If approved by the EC, IMRALDI would be approved for the treatment of rheumatoid arthritis, axial spondyloarthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, polyarticular juvenile idiopathic arthritis, active enthesitis-related arthritis, hidradenitis suppurativa and non-infectious uveitis. The positive opinion is based on a preclinical and clinical data package comparing IMRALDI with Humira. The clinical data include results from two head-to-head studies - a Phase I study in healthy volunteers that demonstrated pharmacokinetic bioequivalence to Humira and a Phase III, randomized, double-blind, multicenter study, in which IMRALDI demonstrated equivalent efficacy and comparable safety and immunogenicity to Humira in patients with RA. The primary endpoint of the Phase III study, the American College of Rheumatology 20% response at Week 24, was met, demonstrating equivalent efficacy to Humira. Secondary endpoints demonstrated that IMRALDI has a comparable safety and immunogenicity profile to Humira.
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AZN | Hot Stocks07:53 EDT AstraZeneca announces positive CHMP opinion for Faslodex - AstraZeneca 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 of Faslodex for the treatment of hormone receptor-positive, HR+, locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on anti-oestrogen therapy.
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ENTA ABBV | Hot Stocks07:49 EDT Enanta announces AbbVie recieves CHMP positive opinion for MAVIRET - Enanta Pharmaceuticals (ENTA) announced that the European Committee for Medicinal Products for Human Use of the European Medicines Agency has granted AbbVie (ABBV) a positive opinion recommending marketing authorization of MAVIRET, an investigational, pan-genotypic treatment for adults with chronic hepatitis C virus infection. If approved, MAVIRET will be a once-daily, ribavirin-free, 8-week treatment option for HCV patients across all genotypes without cirrhosis and new to treatment, who comprise the majority of people living with HCV. The European Commission will now review the CHMP opinion and a final decision is expected in the next quarter. Glecaprevir is Enanta's second protease inhibitor being developed through its collaboration with AbbVie and is one of the two new direct-acting antivirals combined in MAVIRET. The CHMP positive opinion is supported by 97.5% SVR12 rates with 8 weeks of MAVIRET across GT1-6 chronic HCV-infected patients without cirrhosis and new to treatment, with varied patient and viral characteristics. In an integrated analysis, less than 0.4% of patients discontinued treatment. The reported adverse reactions were headache and fatigue. The type and severity of adverse reactions in patients with cirrhosis were comparable overall to those seen in patients without cirrhosis.
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GILD | Hot Stocks07:38 EDT European CHMP adopts positive opinion for Gilead's Vosevi - Gilead Sciences announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company's Marketing Authorization Application for Vosevi, an investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg for the treatment of chronic hepatitis C virus-infected patients. The data included in the application support the use of SOF/VEL/VOX in patients with and without compensated cirrhosis, with all genotypes of HCV infection regardless of prior therapy, including 8 weeks of treatment for HCV direct-acting antiviral-naive patients without cirrhosis, as well as 12 weeks of treatment for patients who have previously failed therapy with a DAA-containing regimen. The CHMP positive opinion was adopted following an accelerated assessment procedure, reserved for medicinal products expected to be of major public health interest. The recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.
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QUIK | Hot Stocks07:35 EDT QuickLogic collaborates with AISpeech - QuickLogic announced that it is collaborating with AISpeech, a leading enterprise of Artificial Intelligence speech technology that is currently focusing on the Chinese market. This collaboration leverages the ultra-low-power integrated voice capabilities of the QuickLogic EOS S3 multi-core System on a Chip to enable mobile, wearable and IoT devices to access the AISpeech cloud-based digital assistant. The first product utilizing the QuickLogic EOS S3 platform to enable AISpeech technology is the Qiwo "hearable" Bluetooth headset.
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SSNLF... | Hot Stocks07:33 EDT Samsung Bioepis' Imrali recommended for approval by EMA - Samsung Bioepis announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion on Imraldi, a biosimilar candidate referencing Humira, for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn's disease, pediatric Crohn's disease, ulcerative colitis and uveitis. The CHMP's positive opinion will now be referred to the European Commission which will review and decide on the grant of a marketing authorization for Imraldi. If a marketing authorization is granted by the EC, Imraldi will be commercialized in the European Union by Biogen (BIIB). Humira is a registered trademark of AbbVie (ABBV). Samsung Bioepis is a JV between Samsung (SSNLF) and Biogen.
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PEG | Hot Stocks07:33 EDT Daniel Eichhorn named President and COO of PSEG Long Island - PSEG announced that Daniel Eichhorn was named President and COO PSEG Long Island effective October 2, 2017. Eichhorn is currently Vice President - Customer Services of PSEG Long Island. Eichhorn succeeds David Daly, who was elected President and COO of PSE&G, New Jersey's oldest and largest gas and electric company. Daly has led PSEG Long Island since October 2013.
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PRKR AAPL | Hot Stocks07:32 EDT ParkerVision: Regional Court of Munich holding decision in case against Apple - ParkerVision (PRKR) announced that the Regional Court of Munich is holding its decision in the ParkerVision v. Apple case until after the German Federal Patent Court rules on the related pending nullity action. The company's final resolution in its German case against LG is also pending this same action. The company believes that a preliminary nullity decision is expected before the end of 2017. The Regional Court of Munich has also streamlined the schedule for the company's second lawsuit against Apple (AAPL) in Germany involving Apple iPhone 7 products using Intel RF receivers. The original schedule was set for two hearings, one in late June regarding infringement and a second hearing to be scheduled after the first hearing later in 2017 or early 2018 regarding validity. The Regional Court has determined it will first review briefs written by the parties and only hold a single hearing for both infringement and validity on November 16, 2017.
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PEG | Hot Stocks07:32 EDT PSEG names of Ralph LaRossa as President, COO of PSEG Power - Public Service Enterprise Group announced the election of Ralph LaRossa as President and COO of PSEG's merchant generation business, PSEG Power effective October 2, 2017. LaRossa is currently President and COO of PSEG's utility business, Public Service Electric and Gas Company. In his new role, LaRossa succeeds Bill Levis who in December 2016 had announced his plans to retire.
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RGEN | Hot Stocks07:30 EDT Repligen enters merger agreement with Spectrum, Inc. - Repligen announced that it has entered into a definitive merger agreement with privately-held Spectrum, Inc. for approximately $359M, comprised of $120M in cash plus 6,154,000 shares of Repligen stock. Spectrum recorded revenue of $40.2M in 2016, with greater than 90% coming from its filtration product portfolio. The addition of Spectrum is expected to accelerate the growth of Repligen's filtration business, provide access to new customers, and greatly expand its commercial footprint, strengthening Repligen's position as a leader in single-use and continuous manufacturing technologies for bioprocessing. The transaction is expected to be completed during Q3.
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ADHD | Hot Stocks07:26 EDT Alcobra engages Ladenburg Thalmann as strategic financial advisor - Alcobra announced that its board is conducting a process to explore and review a range of strategic alternatives focused on maximizing stockholder value from its development assets and cash resources. Alcobra has engaged Ladenburg Thalmann & Co. Inc. to act as its strategic financial advisor for this process. In conjunction with the exploration of strategic alternatives, the company also intends to streamline its operations in order to preserve its capital and cash resources. Alcobra's board has established a Special Committee to explore and evaluate strategic alternatives. Potential strategic alternatives that may be explored or evaluated as part of this process include the potential for an acquisition, merger, business combination or other strategic transaction involving the company. There can be no assurance, however, that this process will result in any such transaction. The company is continuing to assess the best path forward for its Abuse-Deterrent Amphetamine Immediate-Releaseand Metadoxine Extended Release clinical programs.
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SNCR | Hot Stocks07:25 EDT Synchronoss surges after Siris Capital offers to acquire company for $18/share - Shares of Synchronoss have jumped in pre-market trading after the company disclosed in a regulatory filing that Siris Capital Group delivered a letter to the company indicating that they believe they could be in a position to acquire the company in an all-cash acquisition at $18.00 per share of common stock, subject to completion of customary due diligence, including a review of outstanding shareholder litigation and the company's financial statements, as well as the negotiation and execution of a transaction agreement acceptable to the company and Siris. Siris, which holds a roughly 13% stake in Synchronoss, stated in its letter: "We believe that we would be able to complete due diligence, obtain satisfactory financing commitments, and negotiate and sign a definitive agreement within six weeks from the date on which Synchronoss provides a fully-populated data room. We have engaged legal counsel and are prepared to engage financial and accounting advisors to assist us in this potential transaction. In order to commit the time and resources necessary to proceed on this expedited timeframe, we would request a limited period of exclusivity." Synchronoss shares are up $4.68, or 38.4% to $16.86 in pre-market trading after the filing.
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PTI | Hot Stocks07:17 EDT Proteostasis files IND application for PTI-808 with FDA - Proteostasis Therapeutics announced that the company has filed an Investigational New Drug, or IND, application with the FDA for PTI-808, its cystic fibrosis transmembrane conductance regulator, or CFTR, potentiator. Proteostasis plans to initiate a Phase 1 study of PTI-808 in healthy volunteers in July.
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CARA | Hot Stocks07:11 EDT Cara receives breakthrough therapy designation from from FDA for I.V. CR845 - Cara Therapeutics announced that the FDA has granted Breakthrough Therapy designation to I.V. CR845 for the treatment of moderate-to-severe uremic pruritus in chronic kidney disease patients undergoing hemodialysis.
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TIER... | Hot Stocks07:09 EDT TIER REIT announces commencement of Domain 11 development - TIER REIT (TIER) announced it is commencing development of Domain 11, a LEED certified, 16-story office building located within The Domain, one of the nation's live-work-play communities in northwest Austin, Texas. The landmark tower within Austin's "second downtown" is 98% pre-leased to HomeAway (AWAY), the Austin-based vacation rentals business and part of the Expedia (EXPE) family of brands. Construction is scheduled to begin shortly, with a late-2018 targeted delivery date. The building will encompass approximately 324,000 square feet.
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BBRY | Hot Stocks07:08 EDT BlackBerry announces common share purchase program - BlackBerry announced that it has received acceptance from the Toronto Stock Exchange with respect to a normal course issuer bid to purchase for cancellation up to 31M BlackBerry common shares, representing approximately 6.4% of the outstanding public float as at May 31. BlackBerry can purchase the common shares pursuant to the NCIB through the facilities of the TSX, over the Nasdaq Stock Market or through alternative trading systems. Any BlackBerry common shares purchased through the NCIB will be cancelled.
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BLUE | Hot Stocks07:08 EDT bluebird bio presents new data from HGB-205 study of LentiGlobin drug product - bluebird bio announced new data from the ongoing HGB-205 clinical study evaluating its LentiGlobin gene therapy product candidate in patients with transfusion-dependent beta-thalassemia and severe sickle cell disease.These data will be presented by Elisa Magrin, Ph.D., Necker Children's Hospital, Assistance Publique-Hopitaux de Paris, Paris, France in a poster session on Saturday, June 24 at the European Hematology Association Annual Meeting in Madrid, Spain. Marina Cavazzana, M.D., Ph.D., Professor of Medicine at Paris Descartes University and Research Director at the Centre for Clinical Research in Biotherapy, Necker Hospital, and at the Institute of Genetic Diseases, Imagine, Paris, France, is the primary investigator of the HGB-205 study. David Davidson, M.D., chief medical officer, says, "The two most recently treated patients with SCD, both of whom show rising HbAT87Q production, illustrate the potential benefit of some of the protocol modifications that we have made in our separate HGB-206 study in SCD. As with Patient 1204, the first patient with SCD treated in HGB-205, these two patients received a more stringent busulfan conditioning regimen and regular blood transfusions prior to stem cell harvest. Longer follow-up will be required to determine their eventual HbAT87Q production and clinical outcome, but it is encouraging that their in vivo VCN shows evidence of early stabilization at a higher level compared to the initial cohort of patients in HGB-206. It is also important to note that in our HGB-206 study, these modifications are further supplemented with manufacturing process improvements and evaluation of plerixafor for stem cell mobilization, which we believe may further optimize patient outcomes. We are beginning to see evidence of the long-term durability of benefit from treatment with LentiGlobin, with some TDT patients even transitioning off of chelation therapy."
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BLUE | Hot Stocks07:06 EDT bluebird bio announces early data from Phase 3 Northstar-2 study - bluebird bio announced early interim data from the ongoing Northstar-2 Phase 3 clinical study of LentiGlobin drug product in patients with transfusion-dependent beta-thalassemia and non-beta0/beta0 genotypes. These data will be presented by Mark Walters, M.D., UCSF Benioff Children's Hospital, Oakland, California, in an oral session on Sunday, June 25 at the European Hematology Association Annual Meeting in Madrid, Spain. "Northstar-2 is our first study to utilize our improved LentiGlobin drug product manufacturing process to increase the drug product vector copy number and percent of cells transduced. The first patient treated in this study exemplifies the promise of gene therapy, discontinuing blood transfusions approximately a month after treatment and achieving a normal level of total hemoglobin production at six months post-treatment," said David Davidson, CMO. "These early results suggest that the improved manufacturing process results in consistently higher drug product vector copy numbers and lentiviral vector positive cells, which is correlated with higher production of HbAT87Q and ultimately may address known patient-to-patient variability." The Northstar-2 Study is an ongoing, open-label, single-dose, international, multicenter Phase 3 study designed to evaluate the safety and efficacy of LentiGlobin drug product for the treatment of patients with TDT and non-beta0/beta0 genotypes. As of June 2, 2017, drug product had been manufactured for six patients. The median DP VCN for these patients was 3.0, compared to a median DP VCN of 0.7 in Northstar.
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RBA | Hot Stocks07:06 EDT Ritchie Bros. sells $46M+ of equipment in June auction - Ritchie Bros. conducted its third Houston auction of the year this week, selling 4,700+ equipment items and trucks for over $46M, making it the largest June auction ever for the site.
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FINL | Hot Stocks07:06 EDT Finish Line sees Q2 SSS down in low single digit range
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FINL | Hot Stocks07:04 EDT Finish Line: May comps 'below plan'
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TPCA IEP | Hot Stocks07:04 EDT Tropicana, Icahn Enterprises commence modified Dutch auction tender offer - Tropicana Entertainment (TPCA) and Icahn Enterprises (IEP), through its subsidiary Icahn Enterprises Holdings, announced the commencement of a cash tender offer for not less than 2,005,000 and not more than 5,580,000 shares of Tropicana's common stock, par value $0.01 per share, in the aggregate, at a price per share of not less than $38.00 and not greater than $45.00. The tender offer is being made severally, and not jointly, by Tropicana and IEP. The closing price of Tropicana's common stock on the OTCQB Marketplace on (i) June 22, 2017, the last full trading day before the commencement of the tender offer, was $42.00 per share, and (ii) on June 9, 2017, the last full trading day completed prior to the receipt of a letter IEP sent to the Tropicana Board of Directors proposing a potential tender offer, was $39.65 per share. IEP is the beneficial owner of approximately 72.5% of the outstanding shares of Tropicana common stock. The tender offer is scheduled to expire at 5:00 P.M., New York City time, on August 2, 2017, unless the offer is extended.
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FINL | Hot Stocks07:04 EDT Finish Line: Retail environment remains challenging
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BBRY | Hot Stocks07:02 EDT BlackBerry drops nearly 8% in premarket after Q1 revenue misses estimates
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BDSI | Hot Stocks07:01 EDT BioDelivery Sciences announces Health Canada approval of BELBUCA - BioDelivery Sciences announced that Health Canada has issued a Notice of Compliance approving BELBUCA for the management of pain severe enough to require daily, continuous, long-term treatment and is opioid responsive and for which alternative options are inadequate. BDSI plans to commercialize BELBUCA in Canada through a partner, and the approval is an important step in the partnering process. BELBUCA is expected to be launched in Canada in early 2018.
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ARQL | Hot Stocks07:01 EDT ArQule presents preclinical data for ARQ 531 at EHA - ArQule announced that preclinical data for ARQ 531 in diffuse large B-cell lymphoma in vitro and in vivo tumor models was presented at EHA Congress in Madrid, Spain. ARQ 531 is an investigational, orally bioavailable, potent and reversible inhibitor of both wild type and C481S-mutant Bruton's tyrosine kinase. Preclinical data suggests ARQ 531 has the potential for broad clinical utility in a wide range of hematological malignancies and lymphomas. The signaling pathways evaluated show a distinct kinase inhibition profile that could be advantageous in treating lymphomas. ARQ 531, unlike other BTK inhibitors, has activity in both ABC-DLBCL and GCB-DLBCL preclinical models. A phase 1 trial with ARQ 531 in patients with B-cell malignancies refractory to other therapeutic options, including ibrutinib, is planned to commence by the third quarter of 2017.
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ACN AIG | Hot Stocks07:00 EDT Accenture completes termination of U.S. Pension Plan - Accenture (ACN) has completed the termination of its U.S. Pension Plan, which was previously announced in March 2016, by entering into agreements with American General Life Insurance Company- a subsidiary of American International Group (AIG) - and Massachusetts Mutual Life Insurance Co. Under these agreements, the Plan has transferred pension assets to AGL and MassMutual to settle approximately $1B of outstanding pension obligations.
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BBRY | Hot Stocks06:59 EDT BlackBerry says outlook for FY18 'unchanged' - Chen says, ""Our outlook for fiscal 2018 is unchanged. We expect growth at or above the overall market in software and services. We also expect to be profitable on a non-GAAP basis and to generate positive free cash flow for the full year, excluding the benefit of the Qualcomm arbitration award."
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BBRY | Hot Stocks06:59 EDT BlackBerry CEO John Chen says financial foundation is 'solid' - "In Q1, we made great progress strengthening our strategic position in emerging growth markets, most notably in cybersecurity and the Enterprise of Things," said John Chen, Executive Chairman and CEO, BlackBerry. "We secured key design wins in high growth segments of automotive technology, including advanced driver assist, digital instrument cluster and our hypervisor solution. Our ecosystem is growing with Qualcomm and NVIDIA adopting BlackBerry technology for their automotive platforms. Furthermore, we have been recognized once again as a leader in Gartner's Magic Quadrant on the strength of our BlackBerry Secure platform." "Our financial foundation is solid," continued Chen. "We reported non-GAAP profitability for the third consecutive quarter, and our balance sheet continues to strengthen. More importantly, we are better positioned to invest in our strategic areas of focus to drive long-term sustainable growth, while returning capital through share repurchases to further enhance shareholder value."
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HYH | Hot Stocks06:55 EDT Halyard Health CEO Robert Abernathy to retire, Joseph Woody to succeed - Halyard Health announced that Robert Abernathy will retire as CEO, effective June 26. The board has appointed Joseph Woody to succeed Abernathy. Woody has also been elected to serve on the board of directors and Abernathy will continue as chairman of the board.
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MDT | Hot Stocks06:47 EDT Medtronic raises quarterly dividend 7% to 46c per share - The dividend is payable on July 26 to shareholders of record at the close of business on July 7.
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MDT | Hot Stocks06:46 EDT Medtronic announces $5B share repurchase plan - The board authorized the expenditure of up to $5B for new share repurchases. The authorization replaces the previous 2015 repurchase authorization to redeem up to an aggregate number of ordinary shares. There is no specific time-period associated with today's repurchase authorization.
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COH KATE | Hot Stocks06:42 EDT Coach announces extension of tender offer to acquire Kate Spade - Coach (COH) announced that its wholly owned direct subsidiary, Chelsea Merger Sub, has extended the expiration of its previously announced tender offer to purchase all of the outstanding shares of common stock, par value $1.00 per share, of Kate Spade & Company (KATE) at a price of $18.50 per share, net to the seller in cash, without interest thereon and less any applicable withholding taxes until 5:00 p.m., New York City time, on July 10, 2017, unless further extended or earlier terminated. The Offer was previously scheduled to expire at 11:59 p.m., New York City time, on June 23, 2017. The depositary for the Offer has advised Coach and Purchaser that, as of 5:00 p.m., New York City time, on June 22, 2017, 19,310,859 Shares have been validly tendered pursuant to the Offer and not properly withdrawn. The Offer has been extended to allow additional time for the expiration or termination of the waiting period under the Japanese Act on Prohibition of Private Monopolization and Maintenance of Fair Trade, which is expected to expire on July 2, 2017. All other terms and conditions of the Offer remain unchanged.
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KPTI | Hot Stocks06:32 EDT Karyopharm reports updated Phase 2b SADAL data for selinexor - Karyopharm Therapeutics reported updated clinical data from the ongoing Phase 2b Selinexor Against Diffuse Aggressive Lymphoma study evaluating lead product candidate, selinexor, an oral Selective Inhibitor of Nuclear Export / SINE compound, in patients with relapsed or refractory diffuse large B-cell lymphoma. The data will be featured in an oral presentation at the 22nd Congress of the European Hematology Association taking place June 22-25, 2017 in Madrid, Spain. In the SADAL study, selinexor has achieved a 33.3% overall response rate in patients with relapsed or refractory DLBCL after at least two prior multi-agent therapies and who are ineligible for transplantation. The observed responses continue to be durable, with a median duration of response of greater than 7 months, including prolonged complete responses. Dr. Maerevoet commented, "We are highly encouraged by the impressive response rates that continue to be observed with single-agent oral selinexor in these heavily pretreated patients with DLBCL who have received two or more prior therapies and are not eligible for transplantation, and for whom no standard therapy exists. Along with being clinically active and durable, including prolonged complete responses, the 60mg dose continues to be well tolerated with a low incidence of Grade 3 or greater adverse events, which were manageable with dose modifications and standard supportive care." In total, the SADAL study is expected to enroll up to a total of 130 patients in the 60mg single-arm cohort and Karyopharm plans to report top-line results in the second half of 2018.
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TSN | Hot Stocks06:16 EDT Tyson Foods to invest $49M to expand Macon, GA distribution center - Tyson Foods, Inc. is investing $59M to expand its distribution center in Macon, a move that will add jobs, improve efficiency and support the company's plans for growth. The project, which will begin this summer, includes a 152,000-square foot addition to the existing facility. The Macon distribution center currently serves retail and foodservice customers in North Carolina, South Carolina, Georgia, Florida and Alabama. The expansion is expected to be completed in late 2018 and is expected to add more than 100 jobs, bringing total employment at the distribution center to almost 240.
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IBM | Hot Stocks06:05 EDT IBM achieves climate protection goals four years early - IBM announced that it achieved two major commitments four years ahead of schedule in its effort to help combat climate change. "IBM has been one of industry's earliest and unambiguous leaders regarding climate change, having publicly launched our first specific CO2 emissions reduction goal in 2000 and having published a formal position in 2007. The achievements we're announcing today are a testament to our longstanding commitment to protecting our planet by delivering action and results," said Wayne Balta, IBM Vice President of Corporate Environmental Affairs and Product Safety. "We know that businesses must play a leadership role in the fight against climate change, and we continue to lead by reducing our own operational impact and by developing innovative solutions to help our clients do the same." Goal 1: Reduce CO2 emissions associated with IBM's energy consumption 35% by year-end 2020 against base year 2005. IBM achieved 38.1% at year-end 2016, which is approximately equivalent to the emissions associated with the consumption of 1.8 million barrels of oil. IBM's latest accomplishments in relation to CO2 emissions is a result of a decades-long effort throughout which the company has set and met aggressive reduction goals. In fact, by 2005 IBM had already reduced CO2 emissions to 40% of the company's 1990 emissions. Goal 2: Procure electricity from renewable sources for 20% of IBM's annual electricity consumption by 2020. IBM achieved 21.5% at year-end 2016, which is enough to power about 60,000 homes for 1 year. If we also count renewable electricity within the grid mix IBM receives, then 40.1% of IBM's electricity supply across its managed spaces came from renewable sources. IBM set these ambitious goals in February 2015 and subsequently assigned them to the American Business Act on Climate Pledge, a commitment by hundreds of companies demonstrating their support for action on climate change. By the end of 2016, IBM had exceeded both of those commitments four years ahead of schedule. Between 1990 and 2016, the company had conserved 7.2 million MWh of electricity, avoiding 4.4 million metric tons of CO2 emissions and saving over $600 million. The emissions avoidance is equivalent to taking 900,000 cars off the road for a year. In addition to supporting the American Business Act on Climate Pledge, IBM voiced its support for a global climate agreement in 2015. Earlier this month, IBM reaffirmed its support for the Paris Agreement and signed on to the #WeAreStillIn pledge, voicing its commitment to help lead the global fight against climate change.
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NVS | Hot Stocks05:52 EDT Novartis Kisqali receives CHMP opinion as first-line treatment for HR+/HER2- - Novartis announced the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion recommending approval of Kisqali in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative, or HR+/HER2-, locally advanced or metastatic breast cancer as initial endocrine-based therapy. The CHMP recommendation of combining Kisqali with any aromatase inhibitor means that, if approved, oncologists could prescribe Kisqali with letrozole, anastrozole or exemestane, giving them the discretion to select the therapy they believe is most appropriate for each individual patient.
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NVS | Hot Stocks05:50 EDT Novartis: half of eligible patients remain in TFR nearly 2 years after Tasigna - Novartis announced results from additional analyses of the ENESTfreedom and ENESTop clinical trials, which found that approximately half of adult patients with Philadelphia chromosome-positive, or Ph+, chronic myeloid leukemia, or CML, in the chronic phase, or CP, who discontinued Tasigna remain in Treatment-free Remission, or TFR, nearly two years after stopping treatment. The 96-week results from these two open-label Phase II trials, presented at the 22nd Congress of the European Hematology Association, or EHA, add to the growing body of evidence examining the ability to remain in TFR in patients who achieved a sustained deep molecular response, or DMR, with Tasigna and met additional eligibility criteria prior to discontinuing treatment. TFR is the ability to maintain molecular response, or MR, after stopping tyrosine kinase inhibitor, or TKI, therapy in patients with Ph+ CML-CP.
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NVS | Hot Stocks05:45 EDT Novartis pivotal CTL019 6-month follow-up data show durable remission rates - Novartis announced updated results from the ELIANA clinical trial demonstrating CTL019 remission rates are maintained at six months in relapsed/refractory, or r/r, pediatric and young adult patients with B-cell acute lymphoblastic leukemia, or ALL. These data from this pivotal trial of CTL019 show that 83% of patients achieved complete remission, or CR, or CR with incomplete blood count recovery within three months of infusion. No minimal residual disease, or MRD, was detected among responding patients. MRD, which measures the elimination of residual disease in the blood and bone marrow at the molecular level following treatment, is important because it may be an indicator of potential relapse. Results from this study of CTL019 - an investigational chimeric antigen receptor T cell, or CAR-T, therapy - will be presented at the European Hematology Association Annual Meeting. The ELIANA study also showed that the relapse-free probability was 75% at six months and 64% at 12 months among responders. In addition, the probability of survival was 89% at six months and 79% at 12 months. The median time from infusion to data cutoff was 8.8 months.
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GBT | Hot Stocks05:42 EDT GBT announces new data supporting ongoing clinical development of GBT440 - Global Blood Therapeutics announced the presentation of preliminary results from the single-dose adolescent, age 12 to 17, cohort of the ongoing HOPE-KIDS 1 Study, a Phase 2a open-label study of GBT440 in adolescents with sickle cell disease (SCD). The results, which demonstrated that the pharmacokinetics of GBT440 are similar in adolescents and adults, were presented at the 22nd Congress of the European Hematology Association, or EHA, in Madrid. "Because sickle cell disease is a lifelong inherited condition that begins manifestation in childhood, it is critical that adolescent and pediatric patients are included in ongoing research efforts. We believe GBT440 could be particularly impactful in these young patients before much of the irreversible damage associated with SCD occurs," said Ted W. Love, M.D., president and chief executive officer of GBT. "Based on these encouraging pharmacokinetic and safety results, we are expanding our HOPE-KIDS 1 trial to evaluate GBT440 administered at doses of 900 mg and 1,500 mg per day, consistent with the doses currently being administered in the Phase 3 HOPE Study. These data will also be used to support enrolling adolescent patients in the HOPE Study and to inform future GBT440 dose selections for evaluation in a younger pediatric population of children age 6 to 11."
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XLRN CELG | Hot Stocks05:40 EDT Acceleron says results from ongoing trials demonstrate increases in hemoglobin - Acceleron Pharma (XLRN) announced preliminary results from the ongoing Phase 2 studies of luspatercept in patients with lower-risk myelodysplastic syndromes, or MDS, at the 22nd Congress of the European Hematology Association in Madrid, Spain. Luspatercept is being developed to treat a range of hematologic diseases including MDS, beta-thalassemia, and myelofibrosis as part of a global collaboration between Acceleron and Celgene (CELG). "This Phase 2 update further supports our confidence that luspatercept could become a potential first-in-class treatment for lower-risk MDS patients. With some patients continuing on study for more than 26 months, we are very encouraged by both the durability of response and safety profile of luspatercept," said Habib Dable, President and CEO of Acceleron. "With Phase 3 trials across two indications ongoing and new studies planned, we and Celgene remain committed to exploring the full opportunity for luspatercept to transform patients' lives."
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SMHI | Hot Stocks05:35 EDT SEACOR Holdings announces 'stalking horse' bid to form JV with Montco Offshore - SEACOR Marine Holdings announced that Montco Offshore, or MOI, filed a motion with the United States Bankruptcy Court for the Southern District of Texas, Houston Division, in connection with Case No. 17-31646 under which MOI and one of its wholly-owned subsidiaries each filed a voluntary petition for relief under Chapter 11 of Title 11 of the United States Code, for the Bankruptcy Court to enter an order to, among other things, approve MOI's entry into a term sheet, dated June 13, 2017, with a subsidiary of SEACOR Marine that sets forth a summary of the principal non-binding terms of SEACOR Marine's bid to form a new joint venture with MOI. The Term Sheet contemplates that SEACOR Marine and MOI will jointly form and capitalize a new joint venture company by contributing certain liftboat vessels and other related assets to the Joint Venture, as well as requiring the Joint Venture to assume certain operating liabilities and indebtedness associated with the liftboat vessels and related assets. The Joint Venture would consolidate thirteen liftboat vessels currently operated by a subsidiary of SEACOR Marine, six liftboat vessels currently operated by MOI and two liftboat vessels currently operated by an existing joint venture between an affiliate of MOI and an affiliate of SEACOR Marine. The Joint Venture would assume approximately $130M of indebtedness from MOI's credit facilities which, apart from a guarantee of interest payments for two years after the closing of the contemplated transactions, would be non-recourse to SEACOR Marine. In addition, the Joint Venture would assume approximately $76.0 million of indebtedness currently reflected on SEACOR Marine's financial statements. It is expected that SEACOR Marine will be the majority owner of the equity interests in the Joint Venture. If the Bankruptcy Court enters an order to, among other things, approve MOI's entry into the Term Sheet with SEACOR Marine, then SEACOR Marine's ultimate bid will set the minimum acceptable bid for a potential auction under the supervision of the Bankruptcy Court for MOI's assets. It is expected that MOI will conduct a competitive process, pursuant to bidding procedures to be approved by the Bankruptcy Court, seeking higher and better qualified bids for a sale at auction of MOI's assets. Upon approval of the Bankruptcy Court, the bidding procedures will provide that SEACOR Marine is the "stalking horse" bidder for the sale of such assets in connection with the Bankruptcy Cases, and that SEACOR Marine would be entitled to receive a break-up fee and the reimbursement of certain of its expenses (i) upon the consummation of a sale of MOI's assets to any person or entity other than SEACOR Marine or its subsidiaries or (ii) in certain other circumstances where the transactions contemplated by the Definitive Documentation are not consummated. The transactions contemplated to form the Joint Venture will be subject to, among other conditions, SEACOR Marine being selected as the successful bidder in any such auction and Bankruptcy Court approval.
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REVG | Hot Stocks05:31 EDT REV Group learns of LA County MTA approval of recommendation for contract - REV Group and its wholly-owned subsidiary, ElDorado National-California, or ENC, learned that the board of the Los Angeles County Metropolitan Transportation Authority approved the recommendation for award of contract to ENC to supply 295 40-foot CNG powered transit buses. There is a provision for an additional 305 buses or 600 buses in total over a 5-year period. Along with related optional vehicle features, spare parts and training, this contract award represents over $400M in revenue over the contract life.
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