Stockwinners Market Radar for June 08, 2017 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:43 EDT Newell Brands chief development officer acquires 13,170 common shares - In a regulatory filing, Newell Brands chief development officer Richard B. Davies disclosed the purchase of 13,170 common shares of the company for a price of $47.17 per share. The transaction, dated February 14, 2017, brings Davies' total direct common stock ownership to 13,170 shares.

18:17 EDT Petrobras approves execution of Term Sheet with Andrade Gutierrez - Petrobras said that its executive board approved the execution of a Term Sheet with Andrade Gutierrez, providing for a set of integrity obligations for this company, to enable the removal of the provisional ban imposed by Petrobras since December 29, 2014, as disclosed to the market on that date and to allow Andrade Gutierrez to resume participation in Petrobras' bidding process. Andrade Gutierrez became eligible to sign the Term Sheet pursuant to the execution of a leniency agreement with the Federal Prosecutor's Office and the adoption of a set of measures that were verified by Petrobras through integrity due diligence procedure. The obligations provided in the Term Sheet include the maintenance of an effective integrity program in compliance with current anti-corruption legislation, consisting of specific points of improvement defined by Petrobras, based on the outcome of the integrity due diligence procedure, and subject to continuous checking, including the possibility of Petrobras auditing.

18:01 EDT Celanese announces VAE Emulsions price hikes in Europe - Celanese Corporation announced that it will increase the price for emulsions sold in Europe. VAE will be priced at GBP75 per metric ton, PVAC will be priced at GBP75/MT, VAM Copolymers will be priced at GBP75/MT, and Pure Acrylics will be priced at GBP180/MT. Effective July 1, 2017, or as contracts otherwise allow, the price increases will apply.

17:50 EDT Endo confirms FDA request, says evaluating potential options - Endo International said it is aware of today's announcement by the U.S. Food and Drug Administration requesting that Endo voluntarily withdraw OPANA ER from the market. Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward. "While the benefits of opioids in treating and managing pain are widely recognized, the misuse and abuse of these products have increased greatly in the U.S.," the company said in a statement. "As a pharmaceutical company with a demonstrated commitment to the improvement of pain management, Endo feels a strong sense of responsibility to improve the care of pain for patients while at the same time taking comprehensive steps to minimize the potential misuse of its products. Despite the FDA's request to withdraw OPANA ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that OPANA ER has a favorable risk-benefit profile when used as intended in appropriate patients."

17:48 EDT Bravo Brio Restaurant enters into waiver agreement with Wells Fargo - Bravo Brio Restaurant (BBRG) and Wells Fargo Bank (WFC), and certain lenders under the company's credit agreement entered into a waiver agreement. The waiver agreement provides a limited waiver of certain events of default by the company under the credit agreement relating to the company's non-compliance with the consolidated lease-adjusted leverage ratio contained in the credit agreement which arose out of the company's requests for, and borrowings of, loans made during Q2. Pursuant to and subject to the terms of the waiver agreement, the required lenders waived such existing events of default. CFO Jim O'Connors stated, "While we expect to be in full compliance with our current credit agreement by the end of the second quarter, the amendment should provide us additional financial flexibility as we continue to see our operating performance improve."

17:38 EDT SITO Mobile names Brent Rosenthal chairman of the board - SITO Mobile announced that director Brent Rosenthal has been elected chairman of the newly elected board of directors of the company, effective immediately. As previously announced, the newly elected board of directors was seated on June 1, 2017, following the delivery of results certified by an independent inspector of elections with respect to a consent solicitation undertaken by Stephen D. Baksa and Thomas J. Candelaria, along with certain director nominees.

17:35 EDT Bristow Group says chief commercial officer Chet Akiri departs - Bristow Group announced structural and leadership changes to create a strategically realigned and profitable company in an unprecedented downturn. In this downturn, Bristow's clients are focused on safety and increasingly, regional efficiency, and the company must respond. The new Bristow will have two primary geographical hubs in key areas of business, Europe and the Americas, resulting in a more regionally focused, cost efficient and competitive business positioned to win more contracts. When complete, these changes will result in a smaller, more nimble company, with the same intense focus on delivering safe, reliable service to customers, and positioned for future growth and profitability.The structural change into two primary hubs is expected to generate significant cost savings, in part through lower G&A costs. Consequently, Bristow is announcing a number of leadership changes. Alan Corbett has been named vice president Europe, Africa, Middle East, Asia, EAMEA, and will be responsible for operations and commercial development in those areas, including Airnorth and Eastern Airways operations. He will also have oversight of commercial support activities, both in Houston and in the two primary hubs. Corbett joined Bristow in 2014, bringing more than 30 years of oilfield service experience to the company. He previously served as Bristow's regional director for the Europe Caspian Region. Corbett will report directly to Baliff. Rob Phillips has been named vice president Americas, responsible for operations and business development efforts in the U.S. Gulf of Mexico, Trinidad, Canada, Suriname, Guyana, Brazil and Bristow Academy. He will also have global oversight of operational infrastructure support activities. Phillips has over 25 years of offshore aviation experience beginning his career as a pilot. He joined Bristow in 2003 and has served in a number of roles at the company, most recently as vice president of global business operations services. Phillips will continue to report to Baliff. Corbett and Phillips will be supported by a team of leaders with proven track records throughout the industry. They will ensure the delivery of safe, reliable and efficient services to Bristow clients in each of the regions. As part of this new structure, Chet Akiri, senior vice president and chief commercial officer, and Bill Collins, senior vice president global operations, have departed the company and their respective positions have been eliminated. Additionally, Chip Earle, senior vice president and chief legal and support officer, has also departed the company.The announced structural changes also include reducing the corporate group targeting government work, and moving oversight of commercial development, government and operational functions to the leaders in these geographic hubs. These structural changes also include the elimination of several other corporate positions.

17:23 EDT On The Fly: After Hours Movers - UP AFTER EARNINGS: Limoneira (LMNR), up 3.9%... Ascena Retail (ASNA), up 3%. ALSO HIGHER: Collegium Pharmaceuticals (COLL), up 5.1% after the FDA requested that rival Endo (ENDP) remove an opioid pain medication from the market... Zynga (ZNGA), up 3.1% after the stock was upgraded to Overweight from Equal Weight by Morgan Stanley analyst Brian Nowak. DOWN AFTER EARNINGS: Cloudera (CLDR), down 14.1%... Verifone (PAY), down 2.8%. ALSO LOWER: Endo, down 13% after the FDA requested that Endo remove is opioid pain medication, reformulated Opana ER, from the market... Ability (ABIL), down 1.4% after it received a notification from the Listing Qualifications Department of The Nasdaq Stock Market that the company is not in compliance with the minimum bid price requirement.

17:03 EDT Omega Healthcare chairman Bernard Korman retires - Omega Healthcare Investors announced that Bernard Korman retired as chairman of the board of directors, effective as of June 8, 2017, and the board appointed Craig R. Callen as chairman of the board. Korman remains a member of the board.

16:54 EDT DASAN Zhone granted temporary continuing listing on Nasdaq - DASAN Zhone received a letter from NASDAQ stating that the Nasdaq Hearings Panel has granted the company's request for continued listing on The Nasdaq Capital Market provided that, on or before September 27, the company shall have filed with the SEC its Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the period ended March 31, 2017. In addition, the Panel decision requires that the company be able to demonstrate compliance with all requirements for continued listing on Nasdaq and that the company provide prompt notification of any significant events that occur during the extension period. In the event the company is unable to fully comply with the terms of the Panel decision, the company's common stock may be delisted from The Nasdaq Capital Market. The delisting of the company's common stock from The Nasdaq Capital Market could have a material adverse effect on the company's business and on the trading of its common stock.

16:43 EDT QCR Holdings announces plans to acquire Guaranty Bank and Trust Company - QCR Holdings announced the signing of a definitive agreement to acquire Guaranty Bank and Trust Company from Guaranty Bankshares. Established as a de novo bank in 1934, Guaranty Bank is headquartered in Cedar Rapids, Iowa. The acquisition and subsequent merger of Guaranty Bank into Cedar Rapids Bank & Trust Company will enhance the footprint and deposit base of CRBT, a wholly owned subsidiary of QCRH. Guaranty Bank has five banking locations and approximately $267M in assets and approximately $213M in deposits as of March 31. The synergies between the Guaranty Bank and QCR Holdings approach to customer service and community involvement are key components in this strategic acquisition. "QCRH continues to grow our franchise in markets that are important to us," commented Douglas M. Hultquist, President and Chief Executive Officer, "and partnering with a legacy financial institution such as Guaranty Bank is a good strategic fit. The mission, vision and values of both organizations focus on recruiting the best people, delivering exceptional, local client service and building the communities they serve. We are extremely honored to welcome the clients and employees of Guaranty Bank to the QCR Holdings family."

16:38 EDT SAIC relocating central headquarters - SAIC is relocating its corporate headquarters from McLean, Virginia, to Reston, Virginia. The new headquarters will be in leased space in the building previously occupied by Scitor Corp., which SAIC acquired in 2015. The move to Reston will be effective July 1 and is part of an effort to increase efficiencies and consolidate SAIC's office leases in the National Capital Region. SAIC has been leasing its current space in McLean since July 2013, when the Meridian Group purchased it from SAIC's former parent company. SAIC's lease in McLean expires in 2020. SAIC's lease for the Reston facility expires in 2022.

16:36 EDT Aflac president Paul Amos II resigns - Aflac announced that Paul S. Amos, II has resigned from his position as president of Aflac and from the board of directors of Aflac Incorporated to join a private equity firm, effective July 1. Dan Amos, chairman and Chief Executive Officer, is assuming the title of president of Aflac and associated responsibilities. Additional responsibilities will be shared by select members of the executive management team in Japan and the U.S.

16:33 EDT Cohen & Steers: As of May 31 preliminary AUM $59.9B - Cohen & Steers reported preliminary assets under management of $59.9B as of May 31, an increase of $654M from April 30, 2017. The increase was due to market appreciation of $543M and net inflows of $466M partially offset by distributions of $355M. Net inflows for open-end funds and institutional accounts were $255M and $211M, respectively. Distributions for institutional subadvisory, closed-end funds and open-end funds were $283 million, $40M and $32M, respectively. A transfer of $47M was recorded from open-end funds to institutional accounts.

16:32 EDT Franklin Resources reports preliminary AUM $744.7B as of May 31 - Franklin Resources reported preliminary month-end assets under management by the company's subsidiaries of $744.7B at May 31, compared to $741B at April 30, and $737.3B at May 31, 2016.

16:28 EDT Teledyne CEO acquires 10,000 common shares - In a regulatory filing, Teledyne chairman, president, and CEO Robert Mehrabian disclosed the purchase of 10,000 common shares of the company in two tranches of 5,000 shares each. The first tranche was bought at $128.16 per share while the second was bought at $130.65 per share.

16:25 EDT CBIZ acquires CMF Associates - CBIZ has acquired substantially all of the assets of CMF Associates, effective June 1. Founded in 2001, CMF provides transaction and transition-focused financial, operational, and human capital solutions to private equity firms and their portfolio companies across North America. CMF has more than 75 associates including internal staff and outside consultants and recorded approximately $19.2M in revenue in 2016.

16:20 EDT Cloudera reports Q1 subscription revenue $64.7M, up 59% year-over-year - Subscription revenue represented 81% of total revenue, up from 72% in first quarter fiscal 2017.

16:15 EDT Ascena Retail: FY17 results include non-cash pre-tax $1.324B impairment charge - The third quarter of Fiscal 2017 includes a non-cash pre-tax $1.324 billion impairment charge to write down the carrying value of goodwill and other intangible assets to their implied fair value. This impairment charge has no impact on the company's operations, ability to service debt, compliance with financial covenants, or underlying liquidity. The current year period also includes restructuring charges incurred under the Company's Change for Growth program. Current and prior year third quarter results include certain acquisition and integration costs, as well as non-cash purchase accounting adjustments associated with the acquisition of ANN INC., which was completed on August 21, 2015. A summary of year-over-year changes in these items is presented in the notes to the unaudited condensed consolidated financial information, which are included herein.

16:10 EDT Ascena Retail reports Q3 total company SSS down 8%

16:07 EDT Orion Energy sees cutting $3.5M-$4M in annualized costs - Orion Energy recently announced executive management changes and a companywide realignment focused on cost reductions intended to accelerate the company's path to profitability, while maintaining its existing sales and product growth strategies. Orion expects to trim $3.5M-$4M of annualized costs, or approximately 12%-13% versus FY 2017 levels, under its cost reduction plan and will record non-recurring charges related to its cost initiatives totaling $1.5M-$2M, principally in Q1 FY 2018. As part of its cost reduction plan, Orion's executive team and outside directors are reducing their total annual compensation by approximately 35%, compared to FY 2017 levels.

16:05 EDT LMI Aerospace shareholders approve acquisition by Sonaca Group - LMI Aerospace shareholders, at a special meeting, approved the merger agreement for the Sonaca Group's acquisition of LMI. Under the terms of the agreement, LMI shareholders will be entitled to receive $14 per share in cash at the closing of the transaction.

16:01 EDT NYS DFS approves Enzo Biochem's new women's health diagnostics - Enzo Biochem announced that the New York State Department of Health has granted conditional approval for three additional women's health related molecular diagnostic tests for use with the company's versatile and economic AmpiProbe platform. Approval was given for a real-time PCR-based method for qualitative detection of Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis in vaginal swab specimens.

14:39 EDT Ericsson, MasMovil sign strategic agreement for core network evolution - MasMovil, the fourth-largest Spanish operator, announces that it has selected Ericsson to provide a wide array of solutions and services, including core network evolution based on Network Functions Virtualization, enterprise billing, managed and systems support services, and deployment, installation and maintenance of fiber to the home. MasMovil has extended its existing managed and systems support services contracts until the end of 2019, and has the option of extending their scope to include its fixed network.

14:23 EDT Tivity Health jumps 7%, or $2.70, to $38.85

14:07 EDT Caterpillar says mining poised to grow - Says mining poised to grow. Says technology in mining a "game changer."

13:52 EDT Spirit Airlines sees Q2 capacity up 14.5% vs. prior 16.7% view - Sees Q2 TRASN up 4%-5% vs. prior 4.5%-5.5% view. Sees adjusted CASM ex-fuel up 9%-10% vs. previous 3.5%-4.5% view. Sees Q2 economic fuel cost per gallon $1.66.

13:48 EDT Deutsche Asset Management continues equities expansion in U.S. - Deutsche Asset Management announced the continued expansion of its US equities portfolio management team. Daniel Fletcher has joined the firm as Director and portfolio manager focused on the technology, media and telecom sector. Fletcher is based in New York and reports to Sebastian Werner, lead Portfolio Manager for US and Global Growth Equities. In addition, Julia Merz has recently joined the New York team from the Deutsche AM Frankfurt office. Also reporting to Werner, Merz will focus on the healthcare sector and international equities. The expansion of the team follows the hire of David Bianco earlier this year as the Head of Equities in the US and Chief Investment Strategist for the Americas.

13:33 EDT Caterpillar says portfolio positioned for growth - Says portfolio positioned for growth. Says machine replacements will be needed as markets recover. Says original equipment orders on hand have been steadily increasing since mid-2016. Comments taken from slides to be presented at the Deutsche Bank 8th Annual Global Industrials and Materials Summit.

12:49 EDT Freeport CFO: Indonesia exports resumed in April - Says Indonesia exports resumed in April. Says comfortable with debt but still wants to deliver. Says in process to replace 4,000 employees in Indonesia. Says 4,000 absent Grasberg workers seemed to have resigned. Says company "very important" to province of Papua and Indonesia as a whole.

12:32 EDT Freeport CFO: Company doesn't need to make acquisitions for growth - Says copper business "very strong" in the U.S. due to stable workforce and favorable energy costs. Says just completed "major expansion" of mine in Peru. Says doesn't need to make acquisitions for growth.

12:27 EDT Freeport CFO: Company refocused on leading position in global copper industry - Freeport-McMoRan executive VP and CFO Kathleen Quirk said that the annual report theme is "drive by value." Says on a path to meet production targets. Says focused on delivering value to shareholders. Says refocused business on leading position in global copper industry. Says in a period where companies aren't making large investments in new projects. Comments taken from Deutsche Bank 8th Annual Global Industrials & Materials Summit.

12:19 EDT Yahoo stockholders approve sale of operating business to Verizon - Yahoo! (YHOO) announced that stockholders have approved the previously announced proposed sale to Verizon Communications (VZ) of the company's operating business. In addition, Yahoo stockholders voted to approve the advisory vote on the compensation payable to the company's named executive officers in connection with the completion of the transaction. Yahoo anticipates that the sale transaction will close on June 13. As previously announced, following the closing of the transaction, the company will change its name to "Altaba Inc." and register as an investment company under the Investment Company Act of 1940.

12:04 EDT NeuroDerm says ND0701 results 'align with findings' from previous studies - NeuroDerm announced that it will present six posters related to its clinical pipeline in a poster session today from 1:15 p.m. to 2:45 p.m. PT at the 21st International Congress of Parkinson's Disease and Movement Disorders. The Congress is taking place June 4-8, 2017 in Vancouver, B.C. Tami Rachmilewitz, MD, Medical Director at NeuroDerm will present complete demographic data from trial 006 in an abstract titled, "Baseline characteristics of the population enrolled to a randomized clinical study of subcutaneous levodopa/carbidopa infusion in patients with advanced PD." "Patients participating in trial 006 had baseline characteristics typical of advanced Parkinson's disease that was already negatively impacting their motor function," said Oded S. Lieberman, PhD, CEO of NeuroDerm. "That the trial met its primary, key secondary and additional secondary endpoints even in patients with advanced disease is highly encouraging and supports the growing body of data that suggests ND0612 may have potential as a transformative therapy for Parkinson's disease." Both ND0701 and commercial apomorphine appeared to be well tolerated under the conditions of the study and no severe or serious treatment-emergent AEs were reported for any subject. The lowest incidence was following ND0701 2 mg/h. TEAEs were reported in 64.7% of subjects receiving 2 mg/h of commercial apomorphine. The incidence of TEAEs was highest following the initial 1 mg/h dose of ND0701, which is expected on the first day of titration. "The results of trial 101 align with findings from previous preclinical studies that demonstrated expected good local safety and tolerability of ND0701 with comparable PK to commercial apomorphine," noted Dr. Lieberman. "These findings support the continued development of ND0701, and we remain on track to meet with EU regulatory authorities to discuss the ND0701 clinical development plan in the first half of 2017 and to initiate a follow-on PK study by the end of the year."

11:26 EDT T-Mobile sees 'significant' synergy in a combination with Sprint - Braxton Carter, the CFO of T-Mobile, is speaking at the Barclays High Yield Bond & Syndicated Loan Conference.

11:09 EDT Sarepta seen as 'bargain' for potential big pharma buyer - While approval for Sarepta Therapeutic's (SRPT) Exondys 51 in the U.S. was controversial, Oppenheimer analyst Hartaj Singh said it has resulted in a "high level" of short interest and the company would be a "bargain" if it is acquired. BARGAIN SHOPPING: Oppenheimer analyst Hartaj Singh said he thinks Sarepta Therapeutics' current valuation does not reflect the company's FY17 guidance for Exondys 51, its treatment for Duchenne muscular dystrophy, and long-term data on slowing progression of the disease. He added an announcement by CEO Ed Kaye saying the company would return focus to the regulatory and scientific side of the business has fueled speculation of a potential deal. If an acquirer were to target Sarepta, recent biotech deals imply that the company "would be a bargain" just on Exondys 51 worldwide sales potential of $750M and without other exon mutations the company is exploring, the analyst contends. Singh added that he believes a larger company could achieve return on investment at current valuations solely from the global Exondys 51 franchise. In addition, he said investors will be able to gain more visibility on the stock through the company's ongoing earnings update, the release of data on the PPMO platform, and the potential EU approval of Exondys 51 in the first half of 2018. He keeps an Outperform rating on Sarepta with a $76 price target. COMPARABLE DEALS: Singh notes Sarepta shares are currently trading at a 50%-75% discount to recent takeouts in the biotech space, namely Medivation, Ariad and Actelion (ALIOF). Pfizer (PFE) bought Medivation for $14B in 2016, and earlier this year, Takeda Pharma (TKPYY) acquired Ariad Pharmaceuticals for $5.2B, while Johnson & Johnson (JNJ) purchased Actelion and its rare disease-focused business for $30B. NOTABLE: In May, the Wall Street Journal reported that a Sarepta consultant had worked with parents of sick boys to prepare testimony to convince the Food and Drug Administration to approve Exondys 51, or eteplirsen, after trial data for the Duchenne muscular dystrophy treatment proved inconclusive. An FDA advisory committee, the majority of which didn't know Sarepta's involvement with the families, voted against approval 7-6 last year, however that advice was not followed when the agency granted the drug accelerated approval in September, 2016. PRICE ACTION: Sarepta Therapeutics rose 0.4% to $31.53 in morning trading. Since September 19, 2016, the date when the FDA granted approval to Exondys 51, Sarepta shares are up about 12%.

11:01 EDT Boeing reports no new orders in weekly update - Boeing reported no new orders in the weekly update posted on its website. Year to date information: 737 net orders: 72 NG and 93 MAX; 777 net orders: 9 777 and 0 777X.

10:52 EDT United Technologies CFO says doesn't need to do M&A for growth - Says expects $3.5B of share buybacks in 2017. Expects "$1B or so for the next few years" after that. Says not looking to acquire things "willy-nilly." Says company doesn't need to do M&A for growth, but to increase technology content, manufacturing capability.

10:38 EDT United Technologies CFO sees share buybacks tapering off in 2018, 2019

10:36 EDT Aeolus Pharmaceuticals reports FDA fast track designation for AEO 10150 - Aeolus Pharmaceuticals announced that the U.S. FDA has granted Fast Track designation to AEOL 10150 for the prevention of fatal respiratory failure among patients at risk for radiation pneumonitis following a radiological/nuclear incident sufficient to cause the Acute Radiation Syndrome. Aeolus said AEOL 10150 has performed well in preclinical and non-clinical studies, demonstrating statistically significant survival efficacy in an acute radiation-induced lung injury model, and was well-tolerated in two human clinical trials in ALS patients, and is currently being tested in a phase 1 study in healthy subjects. The company believes that AEOL 10150 could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation, whether from cancer therapy or a nuclear event, and potentially reduce lung damage in patients with idiopathic pulmonary fibrosis and people who inhale chemical vesicants, such as sulfur mustard gas.

10:28 EDT Microsoft confirms agreement to acquire Hexadite; terms not disclosed - Microsoft has signed an agreement to acquire Hexadite, a company delivering agentless, automatic incident investigation and remediation solutions. The terms of the agreement have not been disclosed. Hexadite headquarters are based in Boston, with a team of researchers in Tel-Aviv, Israel. Following the close of the deal and after a period of integration, Hexadite will be fully absorbed into Microsoft as part of the Windows and Devices Group. The Fly notes that Reuters said last month Microsoft would acquire Hexadite for $100M.

10:26 EDT United Technologies CFO says 'confident' in ability to deliver guidance - CFO Akhil Johri says "confident" in ability to deliver on guidance. In April, UTX backed FY17 adjusted EPS guidance of $6.30-$6.60 and revenue guidance of $57.5B-$59B. Analysts currently expect EPS of $6.58 on revenue of $59.03B. Says order rates in Europe "starting to look better." Comments taken from the Deutsche Bank Global Industrials and Materials Summit.

10:06 EDT Textron's Bell Helicopter says Bell 505 Jet Ranger X achieves FAA certification - Bell Helicopter, a Textron company, announced that its Bell 505 Jet Ranger X has been certified by the Federal Aviation Administration. Bell Helicopter will continue to work with other certification authorities around the globe. The Bell 505 continues to surpass milestones -- achieving type certification in December 2016 from Transport Canada Civil Aviation, then gaining production certification, and recently celebrating the first customer delivery.

09:54 EDT Urban Outfitters slumps after reporting on sliding same-store sales - Shares of Urban Outfitters (URBN) dropped in morning trading after the retailer said same-store sales for the current quarter have declined by a high single digit percentage. The report comes as Urban and its peers face external consumer market headwinds. COMP SALES UPDATE: In a regulatory filing, Urban Outfitters, the parent company of the Urban Outfitters, Anthropologie and Free People brands, said its current-quarter comparable sales are "thus far" down in the high single digits. The disclosure follows disappointing Q1 results from Urban Outfitters in May, at which time the company reported EPS of 13c on revenue of $761M, below the 16c and $769.81M analysts were expecting. Comparable Retail segment net sales, which include the comparable direct-to-consumer channel, decreased 3.1% for the company, with comparable Retail segment net sales up 1.5% at Free People and down 3.1% at Urban Outfitters and 4.4% at Anthropologie. The decrease in Retail segment comparable net sales was driven by negative comparable store net sales, which were partially offset by continued growth in the direct-to-consumer channel, the company said. At the time, CEO Richard Hayne said total Retail segment comps sales registered a "disappointing" 3% decline, well below plan, which drove increased promotional activity and "more margin pressure than we had anticipated." As in previous quarters, the company said it saw extreme variability in results by channel. Hayne added that the sales shortfall in Q1 was "wholly attributable to weaker-than-expected store channel performance in North America where all three of its brands encountered sluggish customer traffic and sales. This issue is impacting virtually all U.S. brick-and-mortar retailers. There are simply too many stores and too many malls in North America. We expect to see more closures and brands disappear until a healthier balance is reached." MALL-DEPENDENT RETAILERS: Urban Outfitters, like many other mall-dependent retailers, has been impacted by the slowdown in general mall traffic of late. Anchor stores in malls like Macy's (M), J.C. Penney (JCP) and Sears Holdings (SHLD) have struggled over the last few years as consumer trends like e-commerce, notably "the Amazon (AMZN) Effect," have curtailed their brick and mortar sales. Nearly every major department store, including the aforementioned "anchor stores," have collectively closed many stores over the last year. Another peer, bebe (BEBE), also recently reported reduced store traffic due to its mall dependency, citing "the Amazon Effect," and said it would close all of its stores by the end of May. 'ANOTHER NEGATIVE DATA POINT': Commenting on Urban's regulatory filing, Oppenheimer noted that this is "clearly not good," and that this was "yet another negative data point for mall retail." The firm said the "disappointing" update should bring the sellers back to mall-based retail today, and expects names like Gap (GPS), L Brands (LB), American Eagle (AEO), Chico's (CHS), Express (EXPR) and Children's Place (PLCE) to be down "in sympathy." PRICE ACTION: Urban Outfitters is down 9.5% to $16.51 in early trading.

09:35 EDT Hill International selected as project manager for COMPAS Terminal Expansion - Hill International announced that its joint venture with Gomez Cajiao Y Asociados S.A. has received a contract from Compania de Puertos Asociados S.A. to provide project management services in support of the COMPAS Terminal Expansion in Cartagena, Colombia. The three-year contract has an estimated value to the joint venture of approximately $4.1M. Hill is a 40% partner in the joint venture.

09:30 EDT On The Fly: Pre-market Movers - HIGHER: Alibaba (BABA), up 12.8% following a Reuters report that the company is guiding to FY18 revenue growth of 45%-49%... Verastem (VSTM), up 11.3% after its DYNAMO study met its primary endpoint. LOWER: Vail Resorts (MTN), down 3.4% after reporting quarterly results... Comtech Telecomm. (CMTL), down 3.5% after reporting quarterly results.

09:27 EDT 22nd Century, DNRC partner for brain imaging clinical trial - 22nd Century Group announced that it has signed a collaborative research agreement with The Dent Neurosciences Research Center. The agreement features a clinical trial that will use functional magnetic resonance imaging to image the brains of smokers. Participants will smoke 22nd Century's proprietary Very Low Nicotine cigarettes, or conventional cigarettes, which will allow scientists to study both the immediate and longer-term effects of nicotine on brain activity. Recent clinical trial findings suggest that a significant physiological change occurs in the brains of smokers as early as 6 days after switching to Very Low Nicotine cigarettes. Over the course of the Dent trial, researchers will study changes in the physiology of the brains of VLN smokers. As a result, scientists hope to identify changes in the brain that correlate with changes in nicotine addiction.

09:21 EDT Nordstrom says standstill provisions prevent certain actions until Jan. 31, 2019 - After Nordstrom issued a press release announcing that members of the Nordstrom family have formed a group to explore the possibility of pursuing a "going private transaction" involving the acquisition by the group of 100% of the outstanding shares of common stock of the company, the company disclosed some details regarding the history of the announcement in a regulatory filing. The filing states that prior to agreeing to form the group, Blake Nordstrom and Peter Nordstrom requested that the independent members of the company's board consider and approve the formation of the group for purposes of a Washington state statute, which, subject to certain exceptions, prohibits a "significant business transaction" between a Washington publicly traded corporation and a 10% or greater group or a corporation affiliated with such a group over a five-year period from formation of the group. On June 7, a special committee of the board comprised of the independent members of the board approved in advance the formation of the group for purposes of the Moratorium Statute. In connection with the approval of the Moratorium Statute Waiver, the special committee required that the members of the Nordstrom family who are part of the group enter into a letter agreement with the company containing certain non-disclosure, non-use and standstill provisions. The standstill provisions of the letter agreement prevent the members of the group from taking certain actions from the date of the letter agreement until January 31, 2019. The letter agreement provides that, after January 31, 2019, the group automatically disbands and may no longer rely on the Moratorium Statute Waiver.

09:19 EDT Renasant acquisition of Metropolitan Bank approved by Metropolitan shareholders - Renasant announced that the shareholders of Metropolitan BancGroup, the parent company of Metropolitan Bank, voted to approve the merger of Metropolitan with and into Renasant pursuant to the Agreement and Plan of Merger dated as of January 17, by and among Renasant, Renasant Bank, Metropolitan and Metropolitan Bank. Renasant and Metropolitan have already received all regulatory approvals, including approval from the Federal Deposit Insurance Corporation, necessary to complete the proposed merger of Metropolitan with and into Renasant. The merger is expected to be completed on July 1.

09:15 EDT Honeywell invests in cyber security innovation center in Asia Pacific - Honeywell Process Solutions, with the support of the Singapore Economic Development Board, will establish a new industrial cyber security center of excellence for Asia Pacific in Singapore. The COE will feature a state-of-the-art cyber security research and development lab, an advanced training facility and a security operations center that provides managed security services. The new facility in Singapore, which is the first for Asia Pacific, is a further expansion of Honeywell's global network of innovation centers. The facility will also deliver managed industrial cyber security services to help users reduce the risk of security breaches and proactively improve their security posture. Managed services include continuous security and performance monitoring and alerting, security asset management, and incident response with 24 hour expert support 365 days a year.

09:11 EDT Macy's, J.C. Penney rise after Nordstrom says exploring 'go private' deal - Shares of department store operators Macy's (M), J.C. Penney (JCP) and Kohl's (KSS) are all rising in pre-market trading after a member of the industry, Nordstrom (JWN), announced that members of its founding family have formed a group to explore the possibility of pursuing a "going private" transaction.

09:07 EDT Southwestern Energy CFO R. Craig Owen resigns - Southwestern Energy Senior VP and CFO R. Craig Owen has elected to leave Southwestern Energy to accept a new career opportunity with an energy company that does not compete with Southwestern Energy. Owen will remain in his position and continue to support the company through late June to assist with a smooth transition. Southwestern Energy is engaging in a search to identify a permanent CFO. Senior VP, Tax and Treasury, Jennifer Stewart, will fulfill the duties of CFO on an interim basis. Stewart has been with Southwestern Energy since 2010, and previously served as VP, Tax.

09:06 EDT AgroFresh's LandSpring recieves EPA approval for expanded crops - AgroFresh Solutions announced its LandSpring technology has secured EPA approval for its use on 12 additional crops beyond tomatoes and peppers. The innovative pre-transplant technology can now be used on the following seedling crops: broccoli, brussels sprouts, cabbage, cantaloupe, cauliflower, cucumber, eggplant, gherkin, muskmelon, bell pepper, non-bell pepper, summer squash, tomato and watermelon. LandSpring maintains seedling quality through the transplanting process and minimizes the impact of plant stress both during transport and in the field. Application to seedlings 1-3 days prior to transplanting mitigates the negative effects of plant stresses such as heat, cold, drought, excess water, salinity, fertility, disease, insect damage and physical damage. Plants are then able to establish more quickly in the field and maintain better health early in the growing season, which maximizes yield potential for growers. EPA approval of these expanded crops more than doubles the acreage on which LandSpring can be used and now covers most transplanted seedling crops. LandSpring is currently registered for use in the U.S., with the exception of California. California registration has been filed and is expected in 2018/19. In addition, AgroFresh will be establishing global distribution over the next two years as registrations are approved for priority markets.

09:06 EDT Ascensia Diabetes Care announces strategic alliance with Insulet - Ascensia Diabetes Care announced it has entered into a strategic alliance by signing a development agreement with Insulet. Under the terms of this agreement, the Ascensia CONTOUR NEXT ONE blood glucose monitoring system will connect to Insulet's next-generation Omnipod System, which is currently in development. Seamlessly connecting the CONTOUR NEXT ONE BGMS and the Omnipod Dash System will provide people living with diabetes with an innovative continuous insulin delivery system to manage their diabetes, powered by remarkably accurate blood glucose readings.

09:04 EDT Nordstrom jumps 18% after company says exploring deal to go private

09:03 EDT Nordstrom family exploring transaction to take company private - Nordstrom announced that members of the Nordstrom family - company Co-Presidents Blake W. Nordstrom, Peter E. Nordstrom, and Erik B. Nordstrom, President of Stores James F. Nordstrom, Chairman Emeritus Bruce A. Nordstrom, and Anne E. Gittinger - have formed a group to explore the possibility of pursuing a "going private transaction" involving the acquisition by the group of 100% of the outstanding shares of common stock of the company. The group has not made a proposal to the company regarding any such transaction. The company's board of directors has formed a special committee comprised of the independent directors to act on behalf of the company in connection with such exploration by the Nordstrom family and any possible transaction. The special committee has retained Centerview Partners to serve as its financial advisor and Sidley Austin to serve as its legal counsel.

09:02 EDT U.S. Cellular to offer new 10.5-inch iPad Pro, new 12.9-inch iPad Pro - U.S. Cellular (USM) announced it will offer the all-new 10.5-inch iPad Pro (AAPL) and new 12.9-inch iPad Pro, featuring ProMotion technology and the new A10X Fusion chip.

09:00 EDT J.M. Smucker says sees EPS performance significantly weighted towards 2H18

08:56 EDT NewLink conference call ends, shares down 31% to $7.35

08:55 EDT J.M. Smucker: China remains a 'priority market' for long term growth strategy

08:46 EDT China e-commerce names rise after Alibaba guidance - Shares of several names involved in e-commerce and online advertising in China are getting a boost after the leader in the space, Alibaba (BABA), issued much better than expected revenue growth guidance at its investor day meeting. In pre-market trading, Vipshop (VIPS) is up 4.7%, Baidu (BIDU) is rising 2.4%, JD.com is up 5.5% and Baozun (BZUN) has surged 10%.

08:45 EDT J.M. Smucker says product pipeline 'more robust than ever' - Expects to accelerate new product launches in late FY18. Comments from Q4 earnings conference call.

08:38 EDT Mazor Robotics confims Israeli Securities Authority search of offices - In a regulatory filing, Mazor Robotics reported that in May 2017, the Israeli Securities Authority, or "ISA," conducted a search at the offices of Mazor and also questioned certain officers in connection with an investigation held by the ISA. "Mazor has not been informed as to the subject matter of the investigation, nor has it been charged with any wrongdoing. Mazor is cooperating fully with the ISA," the company stated. In pre-market trading, Mazor shares are down over 8% to $34.30.

08:34 EDT NewLink says Roche returning GDC-0919 'obviously disappointing' - NewLink Genetics is speaking on its GDC-0919 business update conference call.

08:34 EDT Celanese provides construction update to polyacetal facilty of Ibn Sina JV - Celanese Corporation (CE) announced an update with respect to the Ibn Sina joint venture and its construction of a 50,000 metric tonne polyacetal manufacturing facility in Jubail Industrial City, Saudi Arabia. Celanese has confirmed that the facility is in the testing phase in preparation for commercial production expected in Q3. Upon successful startup of the polyacetal facility, Celanese's economic interest in Ibn Sina will increase from 25% to a total of 32.5%, providing further financial benefits for Celanese. Ibn Sina is a joint venture between SABIC and CTE, a company jointly owned by subsidiaries of Celanese and Duke Energy (DUK). Celanese, SABIC and Duke Energy entered into the Ibn Sina joint venture in 1981. Construction of the polyacetal facility is part of an extension of the Ibn Sina joint venture, which will run through the year 2032. Subsidiaries of Celanese and Duke Energy each currently hold a 25% interest in the venture, with the remaining 50% held by SABIC.

08:19 EDT Urban Outfitters: Q2 comp retail segment sales high single digit negative so far - In a regulatory filing, Urban Outfitters disclosed that thus far during the second quarter of fiscal 2018, comparable Retail segment net sales are high single-digit negative. Urban Outfitters is down nearly 13% in premarket trading.

08:09 EDT Cascadian Therapeutics says tucatinib granted orphan drug designation by FDA - Cascadian Therapeutics announced that tucatinib, an investigational oral, small molecule kinase inhibitor that is highly selective for HER2 and the company's lead product in development, has been granted orphan drug designation by the FDA for the treatment of breast cancer patients with brain metastases.

08:07 EDT Nxt-ID subsidiary Fit Pay approved as a Visa Token Service Provider - NXT-ID's wholly owned subsidiary Fit Pay announced that its Token Service Provider solution has been successfully integrated with the Visa Token Service. Fit Pay is now qualified as a Visa TR-TSP partner through the Visa Ready Program. The qualification as a Visa TR-TSP provider allows Fit Pay to move forward with the implementation of its payment enablement platform for Internet of Things and wearable devices.

08:06 EDT Long Island Iced Tea announces new distribution agreement in Ecuador, Costa Rica - Long Island Iced Tea announced new partnerships to distribute its beverages in Ecuador through Dinusa S.A. and in Costa Rica through Gaia Foods CRC S.A. Consistent with our strategic focus on Latin America announced in December 2016, Long Island Iced Tea is now distributed across four countries in Central and South America. Ecuador has an estimated population of over 16M and has an NARTD tea market that has grown at a 13% CAGR from 2011 to 2016, and projected to reach $119M by 2021. Costa Rica has a population of just under 5M and has an NARTD tea market that has grown at a 10% CAGR from 2011 to 2016, and projected to reach $123M by 2021.

08:04 EDT Sophiris Bio doses first patient in Phase 2b study of prostate cancer candidate - Sophiris Bio has dosed the first patient in its Phase 2b study to evaluate the safety and tolerability of topsalysin in focally treating men with clinically significant localized prostate cancer. Topsalysin is a first-in-class pore-forming protein engineered to be activated only in the presence of enzymatically-active PSA, which is only found within the prostate. This Phase 2b study will build on the Phase 2a proof-of-concept study for the treatment of localized prostate cancer which demonstrated that a targeted intraprostatic administration of topsalysin has the potential to safely ablate prostate tumor cells.

08:04 EDT Sprint, TIDAL report complimentary six-month trial of TIDAL HiFi - Global music and entertainment platform TIDAL and Sprint are rewarding Sprint customers with an all-access pass to TIDAL's global music and entertainment platform. Beginning June 9, new and existing customers can get six months of TIDAL HiFi for no charge.

08:03 EDT CIBC receives all regulatory approvals for acquisition of PrivateBancorp - CIBC (CM) and PrivateBancorp (PVTB) have received all regulatory approvals required to complete CIBC's acquisition of PrivateBancorp pursuant to their amended merger agreement. CIBC and PrivateBancorp anticipate that the acquisition will close on June 23. The amended merger agreement provides that upon completion of the proposed acquisition, PrivateBancorp stockholders will receive US$27.20 in cash and 0.4176 of a CIBC common share for each share of PrivateBancorp common stock held.

08:01 EDT Forestar: D.R. Horton proposal could be expected to lead to 'superior proposal' - Forestar Group (FOR) announced that its board of directors, after consultation with its outside legal and financial advisors, has determined that the unsolicited, nonbinding proposal received on June 5, 2017 from D.R. Horton (DHI) to acquire 75% of the outstanding shares of Forestar common stock for $16.25 in cash could reasonably be expected to lead to a "Superior Proposal," as defined in Forestar's merger agreement with Starwood Capital Group.Forestar noted that the determination by its board of directors, which is committed to maximizing value for shareholders, allows Forestar to take certain actions in accordance with the procedures set forth in the merger agreement with Starwood to further consider D.R. Horton's proposal, including participating in discussions or negotiations regarding, and furnishing or disclosing information in response to, D.R. Horton's proposal, subject to the execution by D.R. Horton of an executed confidentiality agreement containing terms not less favorable to Forestar than the terms of Forestar's confidentially agreement with Starwood. Forestar previously announced that it had entered into a merger agreement with Starwood on April 13, 2017 pursuant to which Starwood would acquire all of the outstanding shares of Forestar common stock for $14.25 per share in cash, or a total of approximately $605M. Forestar remains subject to the merger agreement with Starwood. Forestar's board of directors is not modifying, withdrawing, amending or qualifying its recommendation in favor of the Starwood merger agreement and the merger contemplated thereby, or proposing to do so, and is not making any recommendation with respect to the D.R. Horton proposal. There can be no assurance Forestar's board of directors will ultimately determine that D.R. Horton's proposal is a Superior Proposal under the terms of the Starwood merger agreement, that the terms of any transaction will be the same as those reflected in D.R. Horton's proposal or that any transaction or definitive agreement will result from D.R. Horton's proposal. JMP Securities LLC is acting as financial advisor to the Company and Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal advisor.

07:59 EDT Energizer appoints Timothy Gorman Interim CFO - Energizer Holdings announced that the company has appointed Timothy Gorman as interim CFO, effective immediately. Gorman will succeed Brian Hamm, EVP and CFO, who is leaving the company to pursue other opportunities. Hamm will work with Energizer to ensure a seamless transition.

07:50 EDT Primoris announces two engineering awards - Primoris Services announced it has been awarded two front end engineering design, or FEED, projects from a major North American refiner. The contracts were secured by the recently formed Primoris Design & Construction, or PDC, part of the Power, Industrial, & Engineering segment. These projects are scheduled to begin in the second quarter of 2017, and anticipated completion is scheduled for the fourth quarter of 2017. In conjunction with the new awards, Primoris has expanded PDC with the addition of twenty-three engineer and design professionals to the Tyler, Texas office. The new employees bring decades of experience in the petrochemical engineering, procurement, and construction industry. Service capabilities include process studies, design studies, FEED, and fabrication/module assembly.

07:43 EDT Regeneron diffuse large b-cell lymphoma treatment granted FDA orphan status - Regeneron Pharmaceuticals' treatment of diffuse large b-cell lymphoma was granted FDA orphan designation, according to a post the agency's website. Reference Link

07:38 EDT Bristol-Myers announces availability of ORENCIA SC administration option - Bristol-Myers Squibb announced today the availability of a new FDA-approved subcutaneous ORENCIA administration option for use in patients two years of age and older with moderately to severely active polyarticular Juvenile Idiopathic Arthritis. The new prefilled syringe offers physicians, patients, and caregivers of these patients the option of ORENCIA treatment that can be administered at home. In 2008, ORENCIA IV was the first FDA-approved IV biologic for use in patients 6 years of age and older with moderately to severely active polyarticular JIA. ORENCIA may be used as monotherapy or concomitantly with methotrexate. ORENCIA should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic RA therapy, such as anakinra. It is not known if ORENCIA SC is safe and effective in children under two years of age. Intravenous dosing has not been studied in patients younger than 6 years of age.The safety and efficacy of ORENCIA ClickJect Autoinjector for subcutaneous injection has not been studied in patients under 18 years of age. In Study JIA-2, an open-label, phase 3 study with a 4-month short-term period and a 20 month open-label extension period, the primary objective was evaluation of PK in order to support the extrapolation of efficacy based on exposure to ORENCIA supported by descriptive efficacy. Pharmacokinetics, safety and efficacy of SC ORENCIA were assessed in patients ages two to 17 years with JIA and an inadequate response to at least one nonbiologic or biologic DMARD. At study entry, 80% of patients were receiving methotrexate and remained on a stable dose of methotrexate. JIA ACR 30, 50, and 70 response rates at 4 months were 81%, 71% and 53%, respectively and were observed to be consistent with the results from the IV study, JIA-1. In general, the adverse events observed in pediatric patients with Juvenile Idiopathic Arthritis were similar in frequency and type to those seen in adult patients.

07:37 EDT AbbVie treatment of lymphatic filariasis granted FDA orphan status - AbbVie's treatment of lymphatic filariasis was granted FDA orphan designation, according to a post to the agency's website. Reference Link

07:33 EDT Dicerna appoints Ralf Rosskamp as chief medical officer - Dicerna Pharmaceuticals (DRNA) announced the appointment of Ralf Rosskamp, as chief medical officer, effective June 15. Rosskamp will be responsible for leading the company's clinical development, medical affairs and regulatory functions. Rosskamp joins Dicerna from Summit Therapeutics (SMMT) where he served as chief medical officer.

07:31 EDT CEL-SCI says CEL-4000 vaccine limited RA progression in study - CEL-SCI Corporation announces the publication of data from rheumatoid arthritis studies in Vaccine, a peer-reviewed journal for researchers interested in vaccines and vaccination. The paper is titled "An epitope-specific DerG-PG70 LEAPS vaccine modulates T cell responses and suppresses arthritis progression in two related murine models of rheumatoid arthritis." As described in the article, investigators from Rush University Medical Center evaluated CEL-SCI's CEL-4000 rheumatoid arthritis vaccine candidate in 2 animal models that resemble the RA disease process in humans better than other animal models. The CEL-4000 treatment vaccine was given to these animals after the onset of RA symptoms. CEL-4000 inhibited disease progression and demonstrated a shift from a pro-inflammatory to an anti-inflammatory environment, as indicated by significant decreases in both RA visual scores and histopathological changes in animals receiving CEL-4000 treatment vaccine. The authors concluded that CEL-4000 exerts its therapeutic effect by interacting with CD4+ cells, which results in an antigen-specific down-modulation of pathogenic CD4+ cell responses through up modulation of CD4+ FoxP3+ Treg cells. "Based on these data and results from prior studies, we believe CEL-4000 could be a potentially valuable asset in the treatment of rheumatoid arthritis and it could be positioned as a first-line treatment to inhibit disease progression in newly diagnosed patients. We are pleased to advance the development of CEL-4000 through the support of the National Institutes of Health and look forward to advancing it into clinical trials in the future," CEL-SCI CEO Geert Kersten added.

07:18 EDT NewLink Genetics to regain rights to GDC-0919 from Genentech - NewLink Genetics (NLNK) announced that on June 6, Genentech, a member of the Roche Group (RHHBY), informed NewLink Genetics that it intends to return the rights to IDO inhibitor GDC-0919 pursuant to the License Agreement dated October 16, 2014. As a consequence of such decision and pursuant to the terms of the agreement, the rights that NewLink Genetics had licensed to Genentech with respect to GDC-0919 will revert to NewLink Genetics when the termination becomes effective. The research collaboration with Genentech for the discovery of next generation IDO/TDO inhibitors continues.

07:15 EDT Mammoth Energy announces multi-year sand contract - Mammoth Energy Services announced it has entered into a multi-year take-or-pay sand contract with a leading third-party service provider. Under the terms of the agreement Mammoth will supply 720,000 tons of sand per year across several grades over a three year period starting on October 1, 2017. The company expects the contract to generate approximately $90M-$100M in total revenues over the contract period, assuming delivery of all contracted volumes.

07:13 EDT AGTC: published data shows 5-year response after single dose of gene therapy - Applied Genetic Technologies and the University of Massachusetts Medical School announced the publication of data demonstrating sustained protein expression five years following a single intramuscular injection of a gene-based therapy for the treatment of alpha-1 antitrypsin, or AAT, deficiency. The study, "5 Year Expression and Neutrophil Defect Repair After Gene Therapy in Alpha-1 Antitrypsin Deficiency" appears in the June issue of Molecular Therapy. AGTC developed the gene-based therapy evaluated in the study, which was led by researchers at the University of Massachusetts Medical School. Alpha-1 antitrypsin deficiency is an inherited genetic defect that results in severe loss of lung function. The study describes five-year follow-up results of a one-time intramuscular injection of a recombinant adeno-associated virus, or AAV,-AAT vector in patients with AAT deficiency who had participated in a Phase 2a trial and had not received subsequent AAT protein therapy. The authors conclude that stable levels of serum AAT achieved in this study over five years may have beneficial clinical effects, despite being below the threshold of what is traditionally considered therapeutic. They hypothesize that continuous expression at a lower level may provide greater clinical benefit compared with levels that fluctuate drastically, as is observed with current AAT replacement therapy. This is analogous to the improvements observed in patients with diabetes receiving continuous insulin infusions compared with those receiving multiple daily insulin injections. Additional studies of intramuscular administration of AAV-AAT will provide further insight into the impact of AAT expression levels on symptoms of AAT deficiency.

07:08 EDT Can-Fite concludes clinical investigator meeting for Phase III arthritis trial - Can-Fite BioPharma recently concluded a successful Investigator Meeting in Europe with approximately 100 rheumatologists including staff from around the world who are participating as clinical investigators in the company's global ACRobat study. ACRobat is a Phase III trial that will evaluate Can-Fite's lead drug candidate Piclidenoson as a first line treatment and replacement for the current standard of care, Methotrexate, the most widely used drug for rheumatoid arthritis. The trial will enroll approximately 500 patients in Europe, Canada and Israel.

07:07 EDT ASCO, Foundation Medicine collaborate to help research sites in TAPUR study - The American Society of Clinical Oncology and Foundation Medicine announced entry into an agreement to create efficiencies for research sites participating in ASCO's TAPUR Study in identifying potential participants for the study. ASCO is announcing that reports from Foundation Medicine's comprehensive genomic profiling assays, FoundationOne, FoundationOne Heme and FoundationACT will receive the new "optimized for TAPUR reporting" designation available to entities that demonstrate reporting of nearly 75% of TAPUR-specific genes in a format that meets criteria established for the TAPUR Study. The TAPUR Study is a first-of its-kind clinical trial designed to evaluate molecularly targeted cancer drugs and collect data on clinical outcomes to learn about additional uses of these drugs outside of indications already approved by the Food and Drug Administration. As part of this pilot program, Foundation Medicine will use its SmartTrials technology to create reports for TAPUR sites that identify patients who may qualify to participate in the TAPUR Study. SmartTrials is a molecularly-matched, location-specific, clinical trials database that informs physicians about clinical trials to accelerate patient enrollment. Early use of the SmartTrials report by one TAPUR site was associated with a significant increase in patient accrual with the site reporting identification of more than 60 patients whose genomic profiles matched TAPUR drug targets within a few months of implementing the SmartTrials technology. As part of this arrangement, Foundation Medicine will be launching its SmartTrials reporting to an initial pilot set of the TAPUR Study's participating clinical sites.

07:06 EDT J.M. Smucker sees FY18 CapEx $310M - Sees FY18 free cash flow $775M, FY18 effective tax rate 32.5%-33%.

07:05 EDT GMS Inc. reprices, extends first lien term loan - GMS Inc announced that its indirect wholly-owned subsidiary, GYP Holdings III Corp. has closed on the refinancing of its existing term loan. The new borrowings consist of a $578M term loan facility due in 2023. Borrowings under the new term loan will bear interest at a floating rate based on LIBOR, with a 1.00% floor, plus 3.00%, representing a fifty basis point improvement compared to the previous term loan's interest rate. Net proceeds from the new term loan and cash on hand were used to repay GYP III's previous first lien term loan of $478M and approximately $94M of loans under its asset based revolving credit facility as well as related expenses.

07:04 EDT Wave Life Sciences, ReadCoor announce research collaboration - ReadCoor and WAVE Life Sciences announced the initiation of a research collaboration to develop a registry of brain cell network maps and advance WAVE's nucleic acid chemistry for targeted delivery to the brain. Over the next two years, ReadCoor and WAVE have agreed to develop a cell map of the mouse brain and to leverage it to characterize stereopure nucleic acid candidates in specific regions, cell types, and subcellular compartments of the brain. This agreement marks the first major industry collaboration for ReadCoor and increases the number of platform collaborations aimed at unlocking next generation targets for WAVE.

07:03 EDT AVEO says Phase 1/2 TiNivo trial of Tivozanib, Opdivo in RCC advances to Phase 2 - AVEO Oncology (AVEO) announced that its Phase 1/2 AVEO-sponsored TiNivo trial evaluating tivozanib in combination with Bristol-Myers Squibb's (BMY) anti-PD-1 therapy, Opdivo, in subjects with advanced renal cell carcinoma has progressed to the Phase 2 portion of the trial. Advancement of the study into the Phase 2 expansion follows the successful completion of the Phase 1 dose escalation portion of the trial, where tivozanib was administered in two escalating dose cohorts in combination with nivolumab at a constant 240 mg every 2 weeks.The combination was well tolerated to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities. The full dose tivozanib regimen of 1.5 mg daily for 21 days, followed by a 7 day rest period, is the recommended Phase 2 dose or the expansion portion of the trial, which is expected to enroll up to an additional 20 subjects. The TiNivo study is being led by the Institut Gustave Roussy in Paris under the direction of Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. Phase 1 results from the ongoing study will be submitted for presentation at an upcoming scientific meeting.

07:01 EDT Alkermes announces initiation of Phase 3 study of ALKS 3831 in YA patients - Alkermes announced the initiation of ENLIGHTEN-Early, a supportive study in the ENLIGHTEN clinical development program for ALKS 3831, an investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia. ENLIGHTEN-Early will evaluate the weight gain profile of ALKS 3831 over a 12-week treatment period compared to olanzapine, an established atypical antipsychotic agent with proven efficacy but also metabolic liabilities including significant weight gain, in young adult patients with schizophrenia, schizophreniform or bipolar I disorder who are early in their illness. ALKS 3831 is designed to provide the strong antipsychotic efficacy of olanzapine and a differentiated safety profile with favorable weight and metabolic properties. ENLIGHTEN-Early is a 12-week, multicenter, randomized, double-blind, phase 3 study comparing the weight gain profile of ALKS 3831 to olanzapine in approximately 250 young adults with schizophrenia, schizophreniform disorder or bipolar I disorder who are early in their illness. Safety and tolerability will also be evaluated in the study. All participants in the double-blind portion of the study will be eligible to continue in an open-label safety study of ALKS 3831 for an additional 24 months. The objective of the extension phase of the study is to assess the long-term safety, tolerability and durability of effect of once-daily, oral ALKS 3831. The ENLIGHTEN clinical development program for ALKS 3831 is comprised of two key studies: a study evaluating the antipsychotic efficacy of ALKS 3831 compared to placebo over four weeks and a study assessing weight gain with ALKS 3831 compared to olanzapine in patients with schizophrenia over six months. The program also includes supportive studies to evaluate the pharmacokinetic and metabolic profile of ALKS 3831, the effect on body weight of ALKS 3831 in young adult patients early in their illness, and long-term safety.

06:36 EDT Hydrogenics signs $50M license agreement for fuel cell bus power modules - Hydrogenics has signed a Purchase and License Agreement for technology and fuel cells with Blue-G New Energy Science and Technology. The Purchase and License Agreement provides that the company will deliver 1,000 fuel cell units to Blue-G to be integrated into zero-emission electric buses and an engineering support component for an aggregate sum payable to the company of over $50M. Delivery of the fuel cells and the associated payments are expected to occur over the next two to three years.

06:32 EDT Novocure: First patient enrolled in RTOG trial of Optune with bevacizumab - Novocure announced that the first patient has been enrolled in the RTOG Foundation's phase 2 pilot trial testing Optune together with bevacizumab for patients with bevacizumab-refractory recurrent glioblastoma. Optune is an FDA-approved Tumor Treating Fields delivery system for the treatment of newly diagnosed and recurrent GBM. In recurrent GBM, both Optune and bevacizumab are approved as monotherapies. The current trial intends to test the efficacy and safety of Optune in combination with bevacizumab for the treatment of patients with bevacizumab-refractory recurrent GBM. The RTOG Foundation Study RTOG 3503 is planned to include 85 patients at 20 institutions in the United States. Patients must have a recurrence or progression of GBM or other grade IV glioma after being treated with bevacizumab. The trial will determine the efficacy of Optune together with bevacizumab measured by overall survival at six months. Additional endpoints include overall and progression-free survival from time of registration, response rates, and toxicities of bevacizumab with Optune.

06:13 EDT Alphabet's Project Wing took part in nationwide tests conducted by NASA, FAA - Project Wing, Alphabet's (GOOG, GOOGL) drone delivery project, in an update on Medium, says that it took part in a set of nationwide tests conducted by NASA and the FAA to explore how to manage the growing number of unmanned aircraft systems in the sky. James Ryan Burgess, Co-Lead of Project Wing, says "As part of these tests, we demonstrated Project Wing's UTM platform at the FAA test site run by the Virginia Tech Mid-Atlantic Aviation Partnership. During yesterday's tests, we showed that our traffic management platform can manage the complex flight paths of multiple UAS at the same time. This is an important step that paves the way to a future where many UAS operators can fly safely together. It also makes it possible for a single operator -- a person or organization -- to fly multiple aircraft simultaneously. Our testing featured 3 Wing aircraft, flown by a single Wing operator, performing package pickup and delivery missions at the same time and in the same area that two Intel Aero Ready to Fly Drones -- operated by Intel (INTC) directly over LTE -- and a DJI Inspire, operated by MAAP, were conducting automated search and rescue missions. Reference Link

06:02 EDT Pentagon: Boeing's Insitu, Textron's AAI each awarded $475M contracts - The Pentagon said yesterday that Textron's (TXT) AAI Corp., Hunt Valley, Maryland, is being awarded a multiple award, indefinite-delivery/indefinite-quantity contract with a $475M maximum combined order ceiling for Mid-Endurance Unmanned Aircraft Systems intelligence, surveillance, and reconnaissance services at multiple locations worldwide. This multiple award contract supports competition at the task order level. This award action includes both firm-fixed-price and cost-reimbursable line items. The contract includes a 54-month period of performance, with four 12-month ordering periods followed by one six-month ordering period. The estimated completion date is not to exceed June 2022. Additionally, Boeing's (BA) Insitu Inc., Bingen, Washington, is being awarded a multiple award, indefinite-delivery/indefinite-quantity contract with a $475M maximum combined order ceiling for Mid-Endurance Unmanned Aircraft Systems intelligence, surveillance, and reconnaissance services at multiple locations worldwide. This multiple award contract supports competition at the task order level. This award action includes both firm-fixed-price and cost-reimbursable line items. The contract includes a 54-month period of performance, with four 12-month ordering periods followed by one six-month ordering period. The estimated completion date is not to exceed June 2022. The Boeing Co., Huntsville, Alabama, was also awarded a $39.66M cost-plus-fixed-fee foreign military sales contract to acquire engineering and technical services necessary to support the Avenger. Oshkosh Defense LLC (OSK), Oshkosh, Wisconsin, was awarded a $21.1M to contract W56HZV-15-D-0031 for 51 recapitalized palletized load systems M1075A1. Work will be performed in Oshkosh, Wisconsin, with an estimated completion date of .Feb. 28, 2019.

06:01 EDT SciClone to be acquired by consortium led by GL Capital for $11.18 per share

05:34 EDT Clearside presents TANZANITE extension study at Annual Macula Society Meeting - Clearside Biomedical announced that at the 40th Annual Macula Society Meeting in Singapore, Charles Wykoff , MD, PhD, presented preliminary results from a non-interventional and retrospective trial of patients who had participated in the completed Phase 2 trial of CLS-TA for suprachoroidal administration, or suprachoroidal CLS-TA, Clearside's proprietary suspension formulation of the corticosteroid triamcinolone acetonide, used together with intravitreally administered Eylea for the treatment of macular edema associated with retinal vein occlusion, or RVO. There were a total of 46 treatment-naive patients with RVO who were enrolled in the Phase 2 trial, known as TANZANITE. The trial included both an active arm of patients who received concomitant suprachoroidal CLS-TA and intravitreal Eylea and a control arm of patients receiving only intravitreal Eylea. As previously reported, patients in the combination arm achieved both additional visual acuity improvements and macular edema reductions over a 3-month period following initial dosing, as compared to patients in the control arm. The objective of the Extension Study was to assess the durability of suprachoroidal CLS-TA in combination with intravitreal Eylea for an additional 6 months following completion of the TANZANITE trial. RVO patients who participated in the TANZANITE trial and did not receive any additional Eylea treatment during its 3-month evaluation period were eligible to be included in the Extension Study. Of the 32 eligible patients, the medical records of 31 patients were obtained for review. Using data from the TANZANITE trial and the Extension Study, time to first RVO re-treatment following the baseline dosing in TANZANITE was determined for patients in both arms. In the preliminary analysis presented today by Dr. Wykoff, 17 of the 23 patients in the combination arm of the TANZANITE trial, or 74%, did not receive any additional treatment over the 9-month period, compared to only 4 of 23 patients, or 17%, in the Eylea arm.