Stockwinners Market Radar for December 19, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:44 EDT Boeing delivers first 737 MAX aircraft for Easter Jet - Boeing delivered the first 737 MAX for Eastar Jet, making it the first airline in Korea to operate the more fuel-efficient and longer-range version of the popular 737 jet. Eastar Jet will take delivery of another 737 MAX 8 airplane later this month, which will join the airline's existing fleet of Next-Generation 737s.

19:36 EDT Deutsche Bank raises prime lending rate to 5.50% from 5.25% - Deutsche Bank announced that its New York Branch, Deutsche Bank New York, and its subsidiary Deutsche Bank Trust Company Americas have raised their prime lending from 5.25% to 5.50% effective tomorrow, December 20, 2018.

19:08 EDT Bilibili to partner with Taobao in e-commerce - Bilibili (BILI) and Taobao Marketplace, China's largest mobile commerce destination under Alibaba Group (BABA), announced that they have entered into a business collaboration agreement in content-driven e-commerce and commercialization of Bilibili's intellectual property assets. Under the agreement, Bilibili and Taobao will collaborate to develop a dynamic ecosystem that will better connect content creators, merchandise and users on both platforms. Specifically, through Bilibili, content creators on Bilibili will register and operate a number of accounts on Taobao, and promote merchandise by producing content in a creative and interactive format. Bilibili and Taobao will also work to promote and commercialize Bilibili's IP assets, leveraging consumer insights on both platforms. Additionally, Taobao will provide Bilibili with e-commerce technical support to ensure a more efficient user experience.

18:43 EDT Walgreens, Verily form partnership to improve health outcomes - Walgreens Boots Alliance (WBA) and Verily, an Alphabet (GOOG) company, announced they will collaborate on multiple projects under a broad agreement aimed at improving health outcomes for patients with chronic conditions, while also lowering the cost of care. Walgreens will be a first-choice retail pharmacy development and commercialization partner to Verily, and the organizations have agreed to work on and explore ways to improve access to advanced healthcare technologies and solutions - which may include sensors and software to help prevent, manage, screen and diagnose disease - with a shared goal of scaling deployment at Walgreens retail locations. Initially, the companies are developing a medication adherence pilot project that will deploy devices and other approaches designed to improve adherence. Walgreens together with Onduo, Verily's joint venture with Sanofi (SNY), will also launch a virtual diabetes solution to Walgreens employees and family members with Type 2 diabetes through the Walgreens employee health plan. Onduo provides tools, coaching and remote access to specialty doctors to help people with diabetes to manage their condition anytime, anywhere. These initiatives are part of a broader strategic alliance designed to combine Verily's healthcare technology innovation with Walgreens corner store presence and trusted pharmacy services.

18:23 EDT DBV Technologies craters after pulling Viaskin Peanut application with FDA - Shares of DBV Technologies (DBVT) are down sharply in the aftermarket session after the company decided to voluntarily withdraw its application for Viaskin Peanut following advisory talks with the FDA. Viaskin Peanut had previously obtained a Fast Track and Breakthrough Therapy designation from the agency for the treatment of peanut allergy in children, but after recent consultation, the company decided that its current Biologics License Application process "lacks sufficient detail regarding data on manufacturing procedures and quality controls". The company noted however that the FDA did not respond with concerns about Viaskin Peanut clinical module and it remains hopeful that "additional information" to support the filing could be gleaned without more clinical studies. PRICE ACTION: In the afterhours session, DBV Technologies' stock price has fallen over 47% to $6.10. In related action, the shares of Aimmune (AIMT), currently in the phase 3 trial process of AR101 in peanut-allergic children, were up 15% at $25 a share. PIPER SEES "COMPETITIVE EDGE" FOR AIMMUNE: In a research note ahead of this evening's decision by DBV Technologies to withdraw the application, Piper Jaffray analyst Christopher Raymond warned that DBV Technologies' Viaskin Peanut may be excluded from the PDUFA program, resulting in "extended review time" for the trial. Raymod gave the "competitive edge" to Aimmune given the FDA's comfort level with the safety profile of AR101.

18:02 EDT United Security Bank raises quarterly dividend to 11c from 10c per share - The dividend is payable on January 15, 2019, to shareholders of record as of January 3, 2019.

18:01 EDT ADMA Biologics provides regulatory update on Bivigam PAS submission - ADMA Biologics announced that the FDA has issued a Complete Response Letter for the drug substance Prior Approval Supplement submission and previously approved the drug product PAS submission. The FDA approved ADMA's drug product PAS submission which was comprised of fill, finish and final release information of the drug product. The FDA issued a CRL to ADMA pertaining to only the drug substance PAS submission which pertains to chemistry, manufacturing and controls information. In the CRL, the FDA did not request any information pertaining to compliance status, clinical study safety and efficacy. The company believes the FDA comments to the drug substance PAS submission are "addressable and resolvable". The company will request a meeting with the FDA to provide the FDA with clarification and responses to the issues raised in the CRL.

17:55 EDT Assurant says will take $110M-$150M pre-tax Q4 loss from California wildfires - Assurant announced that as of December 19, it expects to record between $110M-$150M pre-tax, of fourth quarter 2018 reportable catastrophe losses in its Global Housing segment. This loss range for the quarter includes an initial view of expected losses related to the November Camp Fire and Woolsey Fire in California and a refined range for losses related to Hurricane Michael that occurred in October 2018. The California wildfire losses were primarily driven by fire damage for lender-placed and manufactured housing products. Hurricane Michael losses are related to wind damage for lender-placed and other housing products. The company's reportable catastrophes include individual catastrophic events that generate losses in excess of $5M, pre-tax and net of reinsurance and including reinstatement and other premiums.

17:48 EDT TCF Financial raises prime rate to 5.50% from 5.25% - TCF Financial Corporation and subsidiaries announced today that they are increasing their prime rate to 5.50% from 5.25%, effective tomorrow, December 20, 2018.

17:34 EDT DBV drops 50% to $7.00 after withdrawing peanut allergy application

17:32 EDT S.Y. Bancorp to acquire King Bancorp for $28M - Stock Yards Bancorp has entered into a definitive agreement to acquire all of the common stock of privately held King Bancorp. The all-cash transaction, valued at $28M, is expected to close during 2Q19, subject to customary regulatory approval and completion of closing conditions. King, headquartered in Louisville, is the holding company for King Southern Bank, which operates five branches - three in the greater Louisville area and two in Nelson County, approximately 60 miles southeast of Louisville. As of September 30, 2018, King had approximately $195M in assets, $168M in loans, $126M in deposits and $16M in tangible common equity.

17:30 EDT Newell Brands rises over 5% after Icahn disclosed increased stake

17:22 EDT Aimmune jumps 15% to $25 after DBV withdraws Viaskin Peanut application

17:18 EDT Latam Airlines sees FY19 operating margin of 7%-9% -

17:17 EDT Carbonite CEO sells 13.9K shares of common stock - In a regulatory filing, Carbonite CEO Mohamad Ali disclosed the sale of 13,888 share of common stock at $26.50 per share on December 14th. The total transaction size was $368K.

17:16 EDT HSBC Bank USA raises prime rate to 5.5% - HSBC Bank USA, N.A. and its affiliates announced that they raised their prime and reference rate to 5.50% from 5.25%, effective Thursday, Dec. 20, 2018.

17:10 EDT Magna establishes automatic share purchase plan - Magna has established a pre-defined automatic securities purchase plan with a designated broker to facilitate the purchase for cancellation of Common Shares under its current normal course issuer bid. The plan will be implemented effective January 2, 2019. Under the bid, which terminates on November 14, 2019, Magna is authorized to purchase for cancellation up to 33,200,000 Common Shares. As of December 18, the corporation has repurchased 5,742,454 Common Shares under the bid.

17:05 EDT DBV Technologies voluntarily withdraws BLA for Viaskin Peanut - DBV Technologies' Biologics License Application for Viaskin Peanut in children four to 11 years of age has been voluntarily withdrawn after discussions with the FDA. DBV is currently working to resubmit the application for Viaskin Peanut as quickly as possible. Following feedback from the agency, DBV Technologies concluded that the current BLA lacks sufficient detail regarding data on manufacturing procedures and quality controls. The FDA did not cite concerns related to the clinical module of the BLA for Viaskin Peanut, and the company believes that the additional information needed to support this filing is available without further clinical studies. DBV anticipates that all ongoing clinical trials with Viaskin Peanut will continue as planned.

17:00 EDT Wells Fargo raises prime rate to 5.50% from 5.25% - Wells Fargo Bank is increasing its prime rate to 5.50% from 5.25%, effective tomorrow, Dec. 20, 2018.

16:56 EDT REV Group falls 22% afterhours following Q4 earnings miss, FY19 guidance

16:53 EDT REV Group expects to return to organic sales growth in FY19 - CEO Tim Sullivan: "As we look to fiscal year 2019, we expect improvement in the availability of chassis and flow of raw materials. We are taking actions to increase manufacturing output to meet the ongoing strength of demand and to catch up with the delayed shipments we have experienced. We enter fiscal year 2019 with expectations for a return to growth in organic sales and profitability as well as significantly stronger cash flow generation and higher returns on invested capital. In addition to the monetization of businesses and assets which is expected to generate approximately $40M of cash in fiscal 2019, we have stepped up our focus on cash generation from operations across all our businesses. We are committed to continuing to evaluate our balance sheet and the performance of our portfolio to identify opportunities and actions to achieve our long-term financial objective of greater than 10 percent Adjusted EBITDA margins and to improve shareholder return."

16:33 EDT Pier 1 Imports reports Q3 company comparable sales decrease of 10.5% - Company comparable sales decreased 10.5% compared to Q3 of FY18. The company estimates that the shift of certain holiday selling days, which were not included in last year's Q3, benefited Q3 of FY19 company comparable sales by approximately 600 basis points. The impact of this timing shift is expected to reverse in Q4 of FY19.

16:32 EDT Peak Resorts reports record increase in season pass sales - Peak Resorts reported record season pass sales for the 2018/2019 ski season through December 17. Company-wide season pass sales - including season pass sales to customers of the newly acquired Snow Time properties for the 2018/2019 ski season - are up by approximately 36% on a unit basis and by approximately 38% on a revenue basis, compared with the prior year. In addition, 34% of Snow Time season pass holders upgraded to a Peak Pass. Peak Pass sales are up by approximately 18% on a unit basis and by approximately 20% on a revenue basis, compared with the prior year. Sales of the Drifter Pass, Peak Resorts' unlimited season pass option for 18 to 29-year-olds, are up 27% on both a revenue and unit basis over the prior year.

16:31 EDT AB InBev, Tilray form research partnership over non-alcohol THC, CBD beverages - AB InBev (BUD) and Tilray (TLRY) announced a partnership to research non-alcohol beverages containing tetrahydrocannabinol and cannabidiol. The partnership is limited to Canada and decisions regarding the commercialization of the beverages will be made in the future. The research partnership combines AB InBev's deep experience in beverages with Tilray's expertise in cannabis products. AB InBev's participation will be through its subsidiary Labatt Breweries of Canada, one of the country's founding businesses and its leading brewery, and Tilray's participation will be through its Canadian adult-use cannabis subsidiary High Park company, which develops, sells, and distributes a portfolio of socially responsible cannabis brands and products in Canada. Each company intends to invest up to $50M, for a total of up to $100M.

16:28 EDT Platform Specialty Products VP John Capps buys 50,000 shares of company stock - Platform Specialty Products VP John Capps disclosed in a filing that he had purchased 50,000 shares of company stock at an average price of $10.67 per share between December 17 and December 18. The total transaction value was $533,400.

16:24 EDT Pier 1 down 16% after naming interim CEO, evaluating strategic alternatives

16:23 EDT G&W's Freightliner signs rail-haulage contract with Mendip Rail - Genesee & Wyoming Inc. announced that its UK subsidiary Freightliner Heavy Haul Ltd has signed a long-term, bulk rail-haulage contract with Mendip Rail Ltd, a joint venture between two of the UK's largest aggregate/cement producers, Hanson Aggregates and Aggregate Industries. Under the new contract, commencing in November 2019, Freightliner will haul an expected eight million tons per year of aggregate to terminals in London and the Southeast of England from quarries owned by Hanson and AI in the Mendips, Northern Somerset. As part of the contract, Freightliner will purchase eight locomotives from Mendip Rail, which is expected to occur prior to year-end 2018.

16:22 EDT Pier 1 Imports evaluating strategic alternatives - Pier 1 announced the following actions to enhance shareholder value and position the company for long-term growth and profitability: The company will narrow its strategic focus and hone execution to provide the distinctive Pier 1 style and value proposition desired by customers. The company is implementing a more rigorous cost reduction program expected to generate annualized expense savings beginning in fiscal 2020. The company will continue to manage day-to-day execution with the added resources of an internationally recognized consulting firm. Pier 1's board has initiated a process to evaluate a full range of strategic alternatives to enhance shareholder value and has retained Credit Suisse to assist in this effort.

16:22 EDT FGL Holdings announces cost reduction program - Following a strategic review, FGL Holdings announced a new cost reduction program that is expected to generate approximately $15M of annualized expense savings once completed. A portion of these savings will be reinvested in strategic growth initiatives in 2019, including new capabilities and resources to enter the independent broker dealer and bank channels. With the company's recent ratings upgrade to A- by A.M. Best, F&G sees significant growth opportunities in both of these channels, as well as, further growth within its core IMO channel.

16:21 EDT FGL Holdings names Christopher Blunt CEO - FGL Holdings announced that Christopher Blunt has been appointed as President and Chief Executive Officer succeeding Christopher Littlefield. Additionally, the company introduced a number of actions designed to enhance shareholder value, including additions to the company's leadership team, a new share repurchase program, a quarterly dividend and a cost reduction program. Christopher Blunt served in a variety of senior leadership positions during the nearly 13 years he spent with New York Life. During his tenure, Mr. Blunt was the President of New York Life's $500 billion Investment Group and previously Co-President of the Insurance and Agency Group, which included the company's U.S. Life Operations, Seguros Monterrey New York Life Mexico and AARP Operations. Since January 2018, Mr. Blunt has served as a Senior Managing Director and Chief Executive Officer of Blackstone Insurance Solutions.

16:20 EDT Axis Capital estimates California wildfire related loss at $125M-$150M - AXIS Capital Holdings Limited announced a preliminary pre-tax loss estimate for California wildfires in the range of $125M to $150M, net of estimated recoveries from reinsurance and retrocessional covers and including the impact of estimated reinstatement premiums. The estimate includes losses from aggregate excess of loss reinsurance treaties that were also impacted by losses from other 2018 catastrophe and weather-related events. The company's loss estimate is consistent with industry insured losses of up to $20 billion. The company's preliminary pre-tax loss estimate for Hurricane Michael is currently at the upper end of the previously disclosed range of $100M to $120M.

16:19 EDT Pier 1 Imports appoints Cheryl Bachelder interim CEO - Pier 1 Imports announced that Cheryl Bachelder, a member of the company's board, has been appointed interim CEO, effective immediately. Bachelder succeeds Alasdair James, who has stepped down from the company.

16:19 EDT Chesapeake Utilities acquires Marlin CNG Services - Chesapeake Utilities acquired Marlin CNG Services, a North American supplier of mobile compressed natural gas utility and pipeline solutions. Since 1996, Marlin has been providing virtual pipeline applications to local gas distribution utilities, municipal gas companies, intrastate and interstate pipeline companies, natural gas producers, manufacturers and large industrial customers throughout North America.

16:15 EDT FDA approve's Merck's Keytruda in patients with recurring carcinoma - Merck announced that the FDA has approved KEYTRUDA, Merck's anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma, based on the results of the Cancer Immunotherapy Trials Network's CITN-09/KEYNOTE-017 trial. In this Phase 2 trial of 50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy for their advanced disease, KEYTRUDA monotherapy demonstrated an objective response rate of 56 percent, with a complete response rate of 24 percent and a partial response rate of 32 percent. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Patients received KEYTRUDA 2 mg/kg every three weeks until unacceptable toxicity or disease progression that was symptomatic, rapidly progressive, required urgent intervention, occurred with a decline in performance status, or was confirmed at least four weeks later with repeat imaging. Patients without disease progression were treated for up to 24 months. Assessment of tumor status was performed at 13 weeks followed by every nine weeks for the first year and every 12 weeks thereafter. The major efficacy outcome measures were objective response rate and duration of response as assessed by blinded independent central review per RECIST v1.1.

16:12 EDT Standard Financial announces 240K share repurchase program - Standard AVB Financial announced that the company's board of directors has authorized the repurchase of up to 240,000 shares, or approximately 5%, of the Company's outstanding common stock. The stock repurchase program may be carried out through open market purchases, block trades, negotiated private transactions or pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Securities and Exchange Commission rules. The stock will be repurchased on an ongoing basis and will be subject to the availability of stock, general market conditions, the trading price of the stock, alternative uses for capital and the Company's financial performance. Timothy K. Zimmerman, CEO, noted, "We believe that putting a repurchase plan in place is a prudent action, especially considering the recent volatility in the markets. A repurchase plan is an additional tool that is part of the overall capital management plan of the Company. We strive to manage the Company's capital in a prudent and efficient manner."

16:11 EDT Spectrum down 24% to $7.95 after FDA declines poziotinib breakthrough status

16:10 EDT Northern Trust raises prime rate to 5.5% from 5.25% - The Northern Trust Company has increased its prime rate from 5.25% to 5.50%, effective Thursday, December 20, 2018.

16:08 EDT Amicus provides update on executive team changes - Amicus will promote Daphne Quimi to CFO, effective January 1, 2019. She succeeds Chip Baird who will leave Amicus to pursue other career opportunities in Q1. Quimi has been on the finance senior leadership team at Amicus for 11 years, having served as the Corporate Controller and most recently as Senior Vice President, Finance and Administration. Prior to Amicus, Quimi served as Director of Finance at Bristol-Myers Squibb. Additionally, David Clark has joined Amicus as the first Chief People Officer. Before joining Amicus, Clark spent two years as Vice President of Global Human Resources at Alibaba Group in Hangzhou, China. Previously, he spent eight years at American Express. Ellen Rosenberg has been promoted to Chief Legal Officer. Ellen Rosenberg joined Amicus in February 2016 as General Counsel and Corporate Secretary. Andrew Mulberg has been promoted from VP to SVP, Global Regulatory Affairs. Anthony Sileno has been promoted from VP to SVP, Clinical Operations and Translational Sciences:

16:07 EDT NICE recommends NanoString Prosigna to aid decisions of breast cancer patients - NanoString announced that health officials from the National Institute for Health and Care Excellence, or NICE, in the United Kingdom recently issued a recommendation that includes the use of the Prosigna breast cancer gene signature assay result to guide adjuvant chemotherapy decisions for early-stage breast cancer patients. The guidance is expected to become effective as early as December 19.

16:06 EDT Limoneira raises quarterly dividend by 20% to 7.5c per share - The dividend is payable on January 15, 2019, to stockholders of record on December 31, 2018.

16:02 EDT Air Transport secures rights to fleet of Boeing 767-300ER aircraft - Air Transport Services Group, Inc. (ATSG) announced an agreement with Jetran, LLC to acquire twenty Boeing (BA) 767-300 extended-range passenger aircraft from Jetran over the next three years. The aircraft covered by this agreement are currently operated by American Airlines. They were manufactured between 1993 and 2003, and are powered by General Electric CF6-series engines. ATSG currently expects to begin freighter modification of six of the twenty 767-300s during 2019, up to nine during 2020, and no fewer than five in 2021. Based on that anticipated schedule, and apart from any other transactions involving 767-300s, ATSG projects that it would own at least fifty-nine 767-300 freighter aircraft by the end of 2021, compared with thirty-nine at the end of 2018. ATSG also owns six other passenger 767-300s, all currently operated by its recently acquired passenger airline subsidiary, Omni Air International, and owns other Boeing 737, 757, 767 and 777 aircraft.

16:01 EDT Spectrum says FDA did not grant BTD to poziotinib for treatment of NSCLC - Spectrum Pharmaceuticals, Inc. announced that based on a subset of data from MD Anderson's ongoing Phase 2 study, the U.S. Food and Drug Administration did not grant Breakthrough Therapy Designation to poziotinib for the treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 20 mutations. The company's overall development plan and timeline for a New Drug Application filing based on the first cohort of the ZENITH20 trial remains unchanged. Breakthrough Therapy Designation is one of several FDA programs designed to expedite the review of drugs to treat serious or life threatening conditions. Spectrum's BTD application included data from 30 patients from the MD Anderson Phase 2 study who had failed platinum-based chemotherapy. The data demonstrated a confirmed objective response rate of 40% and median duration of response of 6.6 months. The safety profile in this subset was consistent with historical data published on poziotinib and other tyrosine kinase inhibitors. The historical objective response rates for mutation specific NSCLC patients range between 0% and 8% with tyrosine kinase inhibitors and for non-mutation specific NSCLC patients range between 0.8% and 22.9% with other treatments.

15:20 EDT Seneca Foods trading resumes

15:15 EDT Seneca Foods trading halted, volatility trading pause

14:53 EDT Sabby Management reports 5.39% passive stake in Tonix Pharmaceuticals - In a regulatory filing, Sabby Management disclosed a 5.39% stake in Tonix Pharmaceuticals, which represents roughly 175,000 shares. The filing does not allow for activism.

14:49 EDT FDA grants accelerated approval to pembrolizumab for Merkel cell carcinoma - The Food and Drug Administration announced that it has granted accelerated approval to pembrolizumab, or Keytruda, from Merck for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma, or MCC. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Reference Link

14:18 EDT AstraZeneca, Merck say FDA approves Lynparza as 1st line maintenance therapy - AstraZeneca (AZN) and Merck (MRK) announced that the US Food and Drug Administration has approved Lynparza for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy, as detected by an FDA-approved companion diagnostic test. This is the first regulatory approval for a PARP inhibitor in the 1st-line maintenance setting for BRCAm advanced ovarian cancer. The approval was based on positive results from the pivotal Phase III SOLO-1 trial in which Lynparza reduced the risk of disease progression or death by 70 percent in patients with BRCAm advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy compared to placebo following platinum-based chemotherapy. The safety profile of Lynparza was consistent with previous trials.

14:05 EDT Spirit AeroSystems announces Tulsa, Oklahoma, manufacturing expansion - Spirit AeroSystems announced the company plans to expand operations at its Tulsa, Okla., site by hiring about 250 employees and investing more than $80M in capital projects to support fuselage manufacturing and assembly work. The multi-year expansion project, which begins in 2019, was achieved in partnership with the International Union, United Automobile, Aerospace and Agricultural Implement Workers of America. The state of Oklahoma and City of Tulsa offered incentives to help secure the work statement in Tulsa with support from the Tulsa Regional Chamber of Commerce. The new Tulsa jobs will support increases in 737 production rates by freeing up required space in Spirit's Wichita factory site. The work expansion in Tulsa is part of a larger effort to maximize operational efficiencies across Spirit's sites. As the production rates increase, the Wichita site will continue to hire additional workers to meet the increasing demand. The first phase of the Tulsa work expansion will begin with infrastructure set-up and employee training beginning in 2019. Full rate production is expected to be complete by the end of 2021. Additional investment in equipment, tooling and facilities upgrades will take place through 2022.

13:33 EDT Consolidated Communications does 500K broadband upgrades in Northern New England - Consolidated Communications announced it has completed more than 500,000 broadband upgrades across Northern New England this year offering faster speeds to residents and small businesses. "We're pleased to complete our commitment to upgrade 500,000 homes and small businesses throughout Northern New England with faster broadband speeds," said Bob Udell, president and chief executive officer of Consolidated Communications. "We're committed to bringing faster broadband speeds and enhanced services to Maine, Vermont and New Hampshire. And, we're continuing to invest to offer enhanced products and services and increased network reliability and stability." Upgraded homes and businesses throughout New England will be able to get speeds two to three times faster than what was previously available. Additionally, consumers now have access to the latest, on-demand streaming content including: HBO Now, DIRECTV NowSM, and fuboTV. The company's MyCCIAccount.com center enables existing customers to place new orders and upgrade services online.

12:44 EDT Medicxi Ventures I reports 7.54% passive stake in Synthorx - In a regulatory filing, Medicxi Ventures I LP disclosed a 7.54% stake in Synthorx, which represents over 2.2M shares. The filing does not allow for activism.

12:33 EDT Wells Fargo says $480M securities class action settlement approved by court - Wells Fargo announced that it has received final court approval of an agreement to resolve a previously disclosed consolidated securities class-action in the United States District Court for the Northern District of California alleging certain misstatements and omissions in the company's disclosures related to sales practices maters. Wells Fargo said it is "pleased" the case has received final approval by the court. The $480M settlement agreement provides for payment of class member claims. The settlement class consists of all persons and entities who purchased Wells Fargo & Company common stock from Feb. 26, 2014 through Sept. 20, 2016. The settlement amount was fully accrued as of March 31, 2018 and has been paid into a settlement escrow. The company has denied the claims and allegations in the action and entered into the settlement agreement to avoid the cost and disruption of further litigation.

12:04 EDT AbbVie and Voluntis to develop companion digital therapeutics - Voluntis announces today that it has entered into a collaboration with AbbVie, a research-based global biopharmaceutical company, to enhance patient care coordination in immunology with innovative digital therapeutic software. Together the companies will leverage Voluntis' proven Theraxium technology to make this new solution available to patients and providers in the United States. Pierre Leurent, CEO of Voluntis: "This collaboration illustrates the value of Theraxium in powering next-generation digital therapeutics in wide-ranging therapeutic areas."

12:00 EDT Civitas Solutions rises 12.3% - Civitas Solutions is up 12.3%, or $1.93 to $17.57.

12:00 EDT ABM rises 16.6% - ABM is up 16.6%, or $4.49 to $31.55.

11:56 EDT U.S. Concrete director Theodore Rossi buys 10,000 shares of company stock - U.S. Concrete director Theodore Rossi disclosed in a filing that he had purchased 10,000 shares of company stock at an average price of $34.85 per share. The total transaction value was $348,500.

10:44 EDT Route1 files patent infringement complaint against VMware, AirWatch - Route1 announced that the company filed a complaint, Court File No. T-2149-18, against VMware and its wholly owned subsidiary AirWatch in the Federal Court of Canada for infringement of Route1's Canadian Patent No. 2,578,053, seeking financial compensation for infringement, legal fees, and an injunction. The compensation the Company will be seeking are material when compared to Route1's market capitalization. A patent lawsuit in Canada typically takes at least three years to resolve. Route1 anticipates that its current cash resources and future cash generated from operating performance will be sufficient to fund Route1's estimated cash costs of the litigation through trial. Compensation for infringing activity may be awarded from six years prior to the filing of the lawsuit, and may be calculated on the basis of a royalty on infringing revenues, or profits wrongfully gained from infringing revenues. Route1's Canadian Patent No. 2,578,053, "System And Method For Accessing Host Computer Via Remote Computer", was issued by the Canadian Intellectual Property Office on March 20, 2012, and will expire on September 6, 2025. Canadian Patent No. 2,578,053 is generally directed to using a controller to enable secure communication between a remote device, such as a smartphone or a portable computer, and a host computer. Route1 is the owner of the entire right, title and interest in the 053 Patent, including the sole and undivided right to sue for infringement. In the Company's Statement of Claim, Route1 contends that AirWatch, VMware, and its subsidiary VMware Canada Inc. infringe on Canadian Patent No. 2,578,053 through their sales and provision of services relating to the AirWatch EMM System, which is both offered individually and as a part of VMware's digital workspace platform, VMware Workspace ONE.

10:37 EDT Cantel Medical raises semiannual dividend 17.6% to 10c per share - Cantel Medical Corp. announced today that its Board of Directors approved an increase in its semiannual cash dividend from 8.5c to 10c per outstanding share of the Company's Common Stock. The dividend is payable on January 31, 2019 to shareholders of record at the close of business on January 17, 2019.

10:03 EDT Origin Agritech announces establishment of two additional joint ventures - Origin Agritech announced the establishment of two more new joint ventures: Shandong Aoyu Zhongye in Shandong province and Henan Aoyu Zhongye in Henan province. Origin holds 51% of equity in both of the JVs. The establishment of these two joint ventures, along with the Hubei Aoyu Agricultural Technology Limited in Hubei province, Anhui Aoyu Zhongye Technology in Anhui province and Xuzhou Aoyu Agricultural Technology in Jiangsu province announced previously, completes the first stage of the Origin e-Commune Network development. These five JVs will be the cornerstone of Origin's SEED+ rural e-commerce business. The successful development of these five joint ventures demonstrated the acceptance of the major distributors toward revolutionary e-commune network philosophy in providing integrated and customized technology solution to the farmers across China. The Origin e-Commune Network business has the target of RMB1B revenue during the fiscal year 2019.

10:00 EDT FedEx falls -8.4% - FedEx is down -8.4%, or -$15.61 to $169.40.

10:00 EDT VelocityShares 3x Long Natural Gas ETN falls -15.9% - VelocityShares 3x Long Natural Gas ETN is down -15.9%, or -$13.88 to $73.20.

10:00 EDT Civitas Solutions rises 12.5% - Civitas Solutions is up 12.5%, or $1.96 to $17.60.

09:47 EDT FedEx falls -8.7% - FedEx is down -8.7%, or -$16.04 to $168.97.

09:47 EDT VelocityShares 3x Long Natural Gas ETN falls -16.7% - VelocityShares 3x Long Natural Gas ETN is down -16.7%, or -$14.52 to $72.56.

09:47 EDT Civitas Solutions rises 12.3% - Civitas Solutions is up 12.3%, or $1.93 to $17.57.

09:34 EDT Intec Pharma CEO says 2019 will be 'a year of ongoing evolution' - Intec Pharma announces that Jeffrey Meckler, vice chairman and CEO of Intec Pharma, has issued a Letter to Shareholders. The letter read, in part, "2018 was a transitional year for Intec Pharma, with advances on both the corporate and clinical fronts that we believe put us in a strong position to potentially achieve multiple value driving milestones in the coming year. We believe 2019 will be a year of ongoing evolution. We expect to broaden our Accordion Pill pipeline opportunities, report data on our late-stage clinical program in Parkinson's disease and continue to make significant commercial, clinical and corporate progress that collectively position us for continued growth and success. Our many accomplishments in 2018 were highlighted by the progress we made with our Phase 3 ACCORDANCE clinical trial of AP-Carbidopa/Levodopa to treat the symptoms of advanced PD patients. In October, we completed enrollment of 462 subjects in this pivotal Phase 3 trial and have now randomized greater than95% of the expected 315 patients into the blinded, randomized portion of the study. Preliminary analysis of the baseline data for the randomized population to date shows: Average age of patients was 63 and 65% of enrolled patients were male; Patients had a diagnosis of PD for 8.8 years on average; The average daily levodopa dose for patients upon entering the blinded portion of the study was in excess of 800 mg and the most common Accordion Pill dose was AP-CD/LD 500mg three times per day; Average daily OFF time for patients upon entering the randomized study was approximately 6.1 hours; Approximately 32% of patients were recruited in the U.S. The Phase 2 pharmacokinetic study of AP-CD/LD 50/500 mg dosed three times per day completed enrollment of 12 advanced PD patients in mid-December. Blood samples from the study are scheduled to be batch analyzed at the PK laboratory in Italy during January 2019...We believe the work we are doing now will be key to the development of a winning commercial strategy - whether we select to partner the product or to launch it ourselves. Importantly, we believe our ongoing market assessment continues to strongly support our value proposition and AP-CD/LD's significant market potential. Most notably, we have invested in the commercial scale manufacture of AP-CD/LD, for which we are in partnership with LTS Lohmann Therapie-Systeme AG, the global leader in formulation and film technology manufacturing for the pharmaceutical industry. We are delighted to report that the new product manufacturing line has passed factory testing and is being installed at LTS' dedicated manufacturing space in Andernach, Germany this week. During 2019, we plan to begin the validation, bridging and stability studies needed for regulatory filing and expect these should put us on track for a submission with the U.S. Food and Drug Administration in mid-to-late 2020. We have a meeting planned with the FDA to discuss our commercial scale manufacturing strategy and will have greater granularity on these requirements and timelines in the second quarter of 2019. We made solid progress with our growing development pipeline and are nearing the initiation of our AP-THC PK study. "

09:23 EDT ADMA Biologics says hasn't received FDA communication regarding BIVIGAM's PAS - ADMA Biologics announces that it has not received any formal written communication from the U.S. Food and Drug Administration regarding BIVIGAM's Prior Approval Supplement under the Prescription Drug User Fee Act. When the company receives official written communication from FDA the company will promptly provide appropriate disclosures.

09:18 EDT Comtech awarded $1.7M order from association of Texas counties - Comtech's Safety & Security Technologies group, part of Comtech's Commercial Solutions segment, received an order totaling $1.7M in Q2 to deliver Next Generation 911 services for an association of counties in the State of Texas. Under this order, Comtech will continue to provide Next Generation 911 services to these counties, which Comtech has been supporting under contract since 2011.

09:13 EDT ADT Inc. collaborates with West for enhanced emergency communications - ADT Inc. and West Corporation announced that they have entered into an agreement to enhance customer experiences with 911 emergency communications. Through this arrangement, ADT will use West's emergency response link, or ERL, to help ensure homes and businesses monitored by ADT benefit from the most accurate location data available so that the correct response teams are deployed faster.

09:10 EDT Kratos Defense receives $13.7M single award contract - Kratos Defense announced that it has recently received a $13.7M single award contract for specialized hardware and products in support of a command, control, communication, computing, combat and intelligence, surveillance and reconnaissance program. Due to competitive, customer related and other considerations, no additional information will be provided related to this contract award.

09:08 EDT Entravision extends two agreements with AI & CM Broadcasting - Entravision Communications Corporation announced an extension to their two agreements with Al & CM Broadcasting LLC. Entravision will represent on a network basis and air Alex "El Genio" Lucas through 2020. Alex "El Genio" Lucas is a well-regarded and syndicated morning radio show currently airing on Entravision's "La Suavecita" radio network in 13 markets across the country. The show captures a unique mix of music and conversation with Alex Lucas known by his nickname "Genio" or "Genie" in English.

09:04 EDT Adial Pharmaceuticals amends license agreement with UVA LVG - Adial Pharmaceuticals announced that it has amended its license agreement with the University of Virginia Patent Foundation, d/b/a the University of Virginia Licensing & Ventures Group Pursuant to the amendment, Adial must commence its Phase 3 clinical trial of AD04 for the treatment of Alcohol Use Disorder in 2019. Adial has previously announced that it plans to begin its Phase 3 clinical trial of AD04 in the first half of 2019. The license agreement with the UVA LVG grants Adial exclusive, worldwide and perpetual rights to the intellectual property underlying and protecting AD04, including without limitation, patents issued in 44 jurisdictions that are expected to provide market exclusivity for AD04. Under the license agreement, Adial will pay a total of $1,450,000 in development and approval milestones, a royalty on sales of AD04 of up to 2% with a minimum annual royalty of $40,000, and 15% of any sub-licensing revenue received from third-party sublicensees.

09:01 EDT Arthur J. Gallagher acquires Pointer Insurance Agency, terms not disclosed - Arthur J. Gallagher & Co. announced the acquisition of Southaven, Mississippi-based Pointer Insurance Agency, Inc. Terms of the transaction were not disclosed. Pointer Insurance Agency offers a broad range of property/casualty coverages to businesses and individuals across Mississippi and Tennessee, with a focus on commercial and residential construction, restaurants, the hospitality industry, and artisan contractors. Pointer also offers health, life, disability and long-term care coverages for individuals and families. Jon Pointer, Lisa Metz and their associates will continue to operate from their current location under the direction of Bumpy Triche, head of Gallagher's Mid-South region retail property/casualty brokerage operations, and Robby White, head of Gallagher's South Central region employee benefits consulting and brokerage operations

08:49 EDT BMW, Daimler AG receive approval for merger of mobility services - The BMW Group (BMWYY) and Daimler (DDAIF) are planning the next steps for their joint mobility company, following approval by the responsible competition authorities. The basis for this is the approval of the US competition authorities, which was received on Tuesday, December 18, 2018. This means that all antitrust authorities involved have given the green light for the new joint venture, which is owned in equal parts by the BMW Group and Daimler AG. The joint venture will focus on ensuring the personal freedom of customers in the field of urban mobility. Geared towards this vision of future urban mobility, a new mobility offering will be created that is easy to access, intuitive and focused on the needs of the user. On their urban journey, customers will move through a seamlessly connected and sustainable ecosystem that combines CarSharing, Ride-Hailing, Parking, Charging and Multimodality from a single source and is available with just a few taps. The idea is to create the most attractive, most comprehensive mobility solution for a better life in our connected world. Now that the approval of the competition authorities has been received, the goal is to close this transaction by January 31, 2019. Once this major transaction closes, the new mobility company will present next steps in the first quarter of 2019, in conjunction with the BMW Group and Daimler AG. The equally-owned joint venture will comprise the following activities and services:1) Multimodal and on-demand mobility with moovel and ReachNow. 2) CarSharing with Car2Go and DriveNow. 3) Ride-Hailing with mytaxi, Chauffeur Prive, Clever Taxi and Beat. 4) Parking with ParkNow and Parkmobile Group/Parkmobile. 5) Charging with ChargeNow and Digital Charging Solutions.

08:36 EDT InflaRx receives European approval to initiate IFX-1 study - InflaRx announced the approval of an investigational medicinal product dossier, or IMPD, from the European regulatory authorities, allowing InflaRx to initiate a phase II study with IFX-1, an anti-human complement factor C5a antibody, in patients with ANCA-associated vasculitis. The randomized, double-blind, placebo-controlled phase II study is planned to enroll approximately 80 patients with AAV at about 60 sites in Europe. The main objective of the study is to evaluate the efficacy and safety of IFX-1 in this patient population. The study will be conducted in two parts. Part 1 will compare IFX-1 plus a reduced dose of glucocorticoids versus a standard dose of glucocorticoids, while part 2 will compare IFX-1 alone versus a standard dose of glucocorticoids. All patients will receive standard of care immunosuppressive therapy. The study is expected to initiate in Q1 of 2019.

08:33 EDT Haemonetics to relocate headquarters to Boston - Haemonetics Corporation announced that the company will be relocating its global headquarters to downtown Boston from its current location in Braintree, Massachusetts. Haemonetics' new headquarters will occupy over 62,000 square feet at 125 Summer Street. Haemonetics announced plans to move its global headquarters to 125 Summer Street in downtown Boston. The new Boston headquarters will enable Haemonetics to right-size its footprint by selling its 40-acre campus in Braintree and will provide a sustainable, contemporary workplace, including dedicated lab and research space, to support the company's collaborative, performance-driven culture. The company's corporate and commercial teams will sit side by side with its research and development organizations. The company has signed a multiyear lease through 2032 and expects to have employees located across four floors of the 495,000 square foot LEED and Energy Star certified office tower. The move to the new location is expected to commence within the next year. With approximately 3,000 global employees, Haemonetics expects to move its more than 200 headquarters based positions to the new location.

08:32 EDT Cerus enrolls first patient in Phase 3 ReCePI study - Cerus announced the initiation and first patient enrollment in ReCePI, a randomized, double-blinded, controlled, parallel group, non-inferiority, Phase 3 study to evaluate the efficacy and safety of the INTERCEPT Blood System for red blood cells in patients undergoing complex cardiac surgery procedures. The first patient was enrolled at Houston Methodist Hospital in Houston, Texas.

08:31 EDT General Mills remains 'on track' to deliver FY19 guidance - General Mills says strong cost control drove 1H profit ahead of expectations. 2H focus on topline acceleration in North America retail and pet, while maintaining cost discipline. The company notes the keys to growing the core in FY19 are improve U.S. yogurt, improve emerging markets, strengthen innovation, stabilize U.S. distribution, and increase benefits from price/mix. Information provided in Q2 earnings presentation slides.

08:22 EDT Equillium receives fast track designation from FDA for EQ001 - Equillium announced that the FDA has granted fast track designation for EQ001 for the treatment of acute graft-versus-host disease, or aGVHD. The company is planning to initiate a Phase 1b/2 clinical trial in early 2019, called the EQUATE trial, which will evaluate EQ001 for the treatment of patients presenting with aGVHD. The EQUATE trial is a Phase 1b/2 clinical trial that will enroll approximately 84 patients to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of EQ001 for the initial treatment of aGVHD in combination with corticosteroids. The Phase 1b component is an open-label dose escalation trial and will be followed by the Phase 2 component, which is a randomized, double-blind, placebo-controlled trial in which subjects will receive either EQ001 or placebo in combination with corticosteroids over a two-month period.

08:19 EDT Durect announces commercial launch plans for PERSERIS - DURECT Corporation (DRRX) announced that Indivior (INVVY) stated on December 18, 2018 that it is moving ahead with the launch of PERSERIS in the U.S. with a sales force consisting of approximately 50 representatives. While PERSERIS has been available in the U.S. since November 19, 2018, Indivior stated that the commercial launch is scheduled to take place in February 2019. Indivior stated that its PERSERIS team is currently engaged in creating payor access, growing prescriber awareness and interest, as well as establishing its INSUPPORT patient hub. Indivior reiterated its confidence in its peak net revenue goal for PERSERIS of $200 to $300M. On September 26, 2017, DURECT entered into a patent purchase agreement whereby DURECT assigned to Indivior UK Limited, an affiliate of Indivior PLC, certain patents that may provide further intellectual property protection for PERSERIS. In consideration for such assignment, Indivior made an upfront non-refundable payment to DURECT of $12.5M. Indivior made an additional $5M payment to DURECT in August 2018 following NDA approval of PERSERIS in July 2018. DURECT is also entitled to quarterly earn-out payments that are based on a single digit percentage of U.S. net sales for certain products covered by the assigned patent rights, including PERSERIS. The patent rights include granted patents extending through at least 2026.

08:16 EDT Genomic Health says NICE expands reccomendation for Oncotype DX test - Genomic Health announced that the National Institute for Health and Care Excellence in the United Kingdom has issued its updated guidance again recommending the Oncotype DX Breast Recurrence Score test for use in clinical practice to guide adjuvant chemotherapy treatment decisions for certain patients with early-stage breast cancer. Further, NICE expanded its recommendation to include patients with micrometastases, indicating that some cancer cells have spread to the lymph nodes. The recommendation of the Oncotype DX Breast Recurrence Score test in NICE's updated guidance is based on the test's unique ability to predict who will benefit from chemotherapy and who will not. Importantly, NICE acknowledges Oncotype DX as the only test that reduces the overall number of patients who receive chemotherapy, as well as the only test supported by long-term patient outcomes evidence, including the recently published landmark TAILORx study. Further, NICE also found the Oncotype DX test to be the most cost-effective tool in guiding chemotherapy treatment.

08:14 EDT Eiger announces Breakthrough Therapy designation for lonafarnib - Eiger BioPharmaceuticals announced that the Food and Drug Administration has granted Breakthrough Therapy designation for lonafarnib for the treatment of Hutchinson-Gilford progeria syndrome and progeroid laminopathies. FDA Breakthrough Therapy designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases. Progeria and progeroid laminopathies are ultra-rare, genetic conditions characterized by accelerated aging, with no approved treatment. Eiger is collaborating with The Progeria Research Foundation and plans to submit a new drug application to the FDA in 2019. Lonafarnib is a first-in-class prenylation inhibitor for the treatment for Progeria and progeroid laminopathies.This Breakthrough Therapy designation is supported by data from clinical studies of lonafarnib, demonstrating statistically significant improvements in survival in children with Progeria where the average survival age without treatment is 14.5 years.

08:08 EDT Krystal Biotech completes dosing in Phase 2 study of KB103 - Krystal Biotech announces that four patients have been dosed in the GEM-Phase 2 study of KB103, a topical gene therapy for the treatment of dystrophic epidermolysis bullosa, or DEB. The study is being conducted in adult and pediatric populations to determine whether KB103 administered topically can safely and effectively promote healing of DEB patient wounds. In addition, the study will assess change from baseline in Investigator global assessments and patient reported outcomes, or PRO. This study, being conducted at Stanford University, is a single-center, randomized, placebo-controlled, intra-subject comparison of treatment and placebo wounds. Four patients are being treated in this study. Three chronic wounds are selected per patient; two wounds are randomized to KB103 and one to placebo. Patients will be on trial for approximately six months. The primary objective of this trial is to measure wound healing by imaging. Outcome measures include duration of wound closure relative to placebo, time to wound closure relative to placebo and change of wound surface area relative to baseline and placebo. Secondary outcome measures include change from baseline in the Investigator's Global Assessment score, change from baseline in PRO scales of severity and pain, level of collagen VII in KB103-administrated skin as measured by immunofluorescence and presence of anchoring fibrils as measured by immunoelectron microscopy.

08:06 EDT Flir Systems' surveillance sensors selected by Boeing in U.S. Air Force contract - Flir Systems (FLIR) has been selected by Boeing (BA) to provide the FLIR Star SAFIRE 380-HDc EO/IR surveillance sensor for the U.S. Air Force UH-1N replacement contract. The replacement program will replace the current fleet of USAF UH-1N helicopters, which support the service's nuclear intercontinental ballistic missile bases in Wyoming, Montana and North Dakota. The initial contract award to FLIR is for the first four helicopters, with the total contract up to 84 MH-139 helicopters and valued at more than $40M to FLIR. FLIR will provide its Star SAFIRE 380-HDc airborne surveillance camera as part of the Boeing-Leonardo UH-1N replacement contract. Boeing was awarded a $375.5M firm-fixed-price contract for the non-developmental item integration of the four aircrafts to replace the UH-1N. FLIR has provided the surveillance component for the current UH-1N helicopters in use by the U.S. Strategic Command since the mid-1990's.

08:05 EDT Unisys names Matthew Desch to board of directors - Unisys Corporation (UIS) announced that Matthew Desch has been elected to the Unisys board of directors, effective January 1, 2019. Desch has served as chief executive officer and a director of Iridium Communications (IRDM), a McLean, Va.-based, global mobile satellite communications company, since 2006.

08:04 EDT Gilead and Scholar Rock collaborating in fibrotic disease therapies - Gilead (GILD) and Scholar Rock (SRRK) have entered into a strategic collaboration to discover and develop highly specific inhibitors of transforming growth factor beta activation for the treatment of fibrotic diseases. Under the collaboration, Gilead has exclusive options to license worldwide rights to product candidates that emerge from three Scholar Rock TGFbeta programs: inhibitors that target activation of latent TGFbeta1 with high affinity and specificity, inhibitors that selectively target activation of latent TGFbeta1 localized to extracellular matrix, and a third TGFbeta discovery program. Scholar Rock is responsible for antibody discovery and preclinical research through product candidate nomination, after which, upon exercising the option for a program, Gilead will be responsible for the program's preclinical and clinical development and commercialization. Scholar Rock retains exclusive worldwide rights to discover, develop, and commercialize certain TGFbeta inhibitors for oncology and cancer immunotherapy. Scholar Rock will receive $80M in upfront payments, comprised of $50M cash and $30M purchase of Scholar Rock common stock. In addition, Scholar Rock will receive a one-time milestone payment of $25M upon the successful completion of specific preclinical studies and be eligible to receive up to an additional $1,425M in potential payments aggregated across all three programs based on the successful achievement of certain research, development, regulatory and commercialization milestones. Scholar Rock would also receive high single-digit to low double-digit tiered royalties on sales of potential future products originating from the collaboration.

08:03 EDT Aimmune initiates Phase 3 POSEIDON trial - Aimmune Therapeutics announced that it has initiated Peanut Oral Immunotherapy Study of Early Intervention for Desensitization, or POSEIDON, an international, Phase 3 clinical trial of AR101 in peanut-allergic children ages 1-3 years. AR101 is Aimmune's investigational biologic oral immunotherapy for desensitization of patients with peanut allergy. The primary efficacy endpoint for POSEIDON is tolerating a 600-mg single dose of peanut protein (the equivalent of approximately two peanut kernels) with no more than mild symptoms in a progressive, exit, double-blind, placebo-controlled food challenge after approximately one year of treatment.

08:02 EDT Accenture awarded U.S. patent for quantum computing technology - Accenture has been granted a US patent for a "multi-state quantum optimization engine" that leverages quantum computing technology to help organizations optimize business decision making. Accenture's patent describes an optimization engine that helps organizations identify a broader range of solutions to business challenges.

07:58 EDT Elbit Imaging announces FDA approval for Insightec Exablate Neuro indication - Elbit Imaging announced that Insightec informed that the Center for Devices and Radiological Health, or CDRH of the FDA has approved an expansion of the indication of Exablate Neuro to include the treatment of patients with tremor-dominant Parkinson's disease, or PD. This expansion adds medication-refractory tremor from PD to the current Exablate Neuro indication for incisionless, focused ultrasound thalamotomy for medication-refractory essential tremor. The company holds approximately 63% of the share capital of Elbit Medical Technologies which, in turn, holds approximately 22% of the share capital in Insightec.

07:39 EDT Thermo Fisher's pending Gatan acquisition requires further UK review - Thermo Fisher Scientific (TMO) and Roper Technologies (ROP) announced that Thermo Fisher's pending acquisition of Gatan, a wholly owned subsidiary of Roper, requires further review by the Competition and Markets Authority in the UK. Both parties continue to work cooperatively with the CMA through the review process. All other regulatory approval conditions have been satisfied.

07:35 EDT B. Riley Financial says Rent-A-Center termination of merger agreement invalid - B. Riley Financial (RILY) issued the following statement in response to Rent-A-Center's (RCII) purported termination of its merger agreement with affiliates of Vintage Capital Management: "The company has worked collaboratively and proactively with Vintage Capital and Rent-A-Center's management team on this transaction. We support the position that Rent-A-Center's purported termination of the merger is invalid and that its actions constitute a material breach of the merger agreement. The Company supports Vintage Capital in its pursuit to enforce its rights"

07:32 EDT Prometic Life Sciences CEO Pierre Laurin steps down - The Board of Directors of Prometic Life Sciences announced that it has named Prof. Simon Best as interim CEO, effective immediately. Prof. Best has been the chairman of the Prometic Board of Directors since May 2014 and has over 30 years of global life sciences expertise with a focus on business development, strategic planning and product commercialization. Best succeeds Mr. Pierre Laurin who has stepped down from his management and board responsibilities, effective immediately. The Corporation is appointing a top-tier global search firm to commence the search for a permanent CEO. The corporation is also pleased to announce that Zachary Newton has been appointed to the Board of Directors as the second designee of Structured Alpha LP, an affiliate of Thomvest Asset Management.

07:20 EDT Bausch Health to reduce debt by additional $76M - Bausch Health Companies announced it put in notice to pay down an additional $76M of its senior secured term loans next week, using cash generated from operations. After this payment, the Company will have eliminated all mandatory amortization for the first quarter of 2019. In addition, as previously disclosed, Bausch Health redeemed or called for redemption $325M of debt earlier in the fourth quarter of 2018. Together, these transactions bring the Company's total debt repayment in this quarter to approximately $400M.

07:18 EDT Sutro Biopharma earns $10M milestone payment from Celgene - Sutro Biopharma (STRO) announced that the company earned $10M in a milestone payment from Celgene (CELG) triggered by the successful development of a dry powder XtractCF formulation, using spray drying technology, which is well established in the pharmaceutical industry. Dried XtractCF is a significant advancement, facilitating the commercial-scale manufacturing of protein therapeutics, using Sutro's proprietary cell-free XpressCF technology for its fully owned and partnered programs. This collaboration was originally signed in September 2014 and amended in August 2017. According to the terms of the agreement, Celgene acquired worldwide rights to one collaboration program to reach IND status and maintains an option to obtain worldwide rights to a second collaboration program. Sutro will retain U.S. development and commercialization rights and Celgene will retain ex-U.S. rights for the remaining collaboration programs. Sutro is entitled to development and regulatory milestone payments and royalties from Celgene.

07:16 EDT Phoenix New Media announces strategic investment in Tadu - Phoenix New Media announced that it has entered into an agreement with Telling Telecommunication, the sole shareholder of Beijing Yitian Xindong Network Technology, to acquire 25.5% equity interests in Yitian Xindong for an aggregate purchase price of RMB144M, subject to certain price adjustment mechanisms based on Yitian Xindong's operating and financial performance in 2019 and 2020. Before the Acquisition, Yitian Xindong is a wholly owned subsidiary of Telling Telecom, which is listed on the main board of the Shenzhen Stock Exchange. Yitian Xindong owns the mobile application Tadu, a leading online reading application in China that currently has more than one million daily active users. Concurrently, Telling Telecom also agreed to transfer another 25.5% equity interests in Yitian Xindong to Shenzhen Bingruixin Technology. Bingruixin will grant an option that will allow the Company to acquire the 25.5% equity interests from Bingruixin for RMB144M, subject to certain price adjustment mechanisms based on Yitian Xindong's operating and financial performance in 2019 and 2020. Before the Company exercises such option, Bingruixin agreed to entrust voting rights with respect to the 25.5% equity interests in Yitian Xindong to the Company prior to March 15, 2019. Because of the Voting Rights Entrustment, the Company expects to be able to consolidate Yitian Xindong upon completion of the Acquisition. However, if the Company explicitly renounces the Call Option or does not exercise the Call Option before March 15, 2019, both the Call Option and the Voting Rights Entrustment will automatically expire.

07:14 EDT Anixa Biosciences completes Pre-Sub meeting with FDA for Cchek test - Anixa Biosciences announced that it completed a Pre-Submission meeting with the US FDA on December 17, 2018. The meeting was focused on discussing Anixa's Cchek test, an artificial intelligence based liquid biopsy for the early detection of cancer. Specifically, the discussion focused on using Cchek for prostate cancer testing, as prostate cancer will be the first commercial application. Anixa Biosciences expects the official minutes of the Pre-Sub meeting to be available in January. On January 24, 2019 Anixa plans to hold a conference call where it will discuss the commercialization path and timeline for Cchek-Prostate, as well as an update on its CAR-T therapeutics program. The details of the conference call will be provided at a later date.

07:09 EDT Avrobio receives orphan designation from FDA for RD-01 - Avrobio announced that the FDA has granted orphan-drug designation for the company's investigational gene therapy, AVR-RD-01, for the treatment of Fabry disease. The gene therapy consists of the patient's own hematopoietic stem cells transduced with Avrobio's lentiviral vector, carrying a functional version of the GLA gene that encodes a-galactosidase, the enzyme that is deficient in Fabry disease. Patients with Fabry disease are currently enrolling in AVRO-RD-01-201, the company's Phase 2 clinical trial, as well as in an investigator-sponsored Phase 1 study.

07:07 EDT SPX FLOW appoints Jaime Easley as VP, CFO - SPX FLOW announced the appointments of Jaime Easley as VP and CFO and Ryan Taylor as chief strategy officer, effective immediately. Easley has served as VP, Corporate Controller and Chief Accounting Officer and Taylor has served as Vice President of Communications and Investor Relations since the company's spin off from SPX Corporation in September 2015. Easley will succeed Jeremy Smeltser who has resigned from the company after serving as Vice President and CFO over the past three years.

07:07 EDT Myriad says EndoPredict test receives NICE recommendation - Myriad Genetics announced that the United Kingdom's National Institute for Health and Care Excellence has included EndoPredict in its recommendations for guiding adjuvant chemotherapy decisions for people with ER-positive, HER2-negative early breast cancer and who are lymph node-negative. After an extensive technical review, NICE concluded that the clinical evidence justifies EndoPredict for patients with intermediate risk of distant recurrence as determined by a validated tool such as PREDICT or the Nottingham Prognostic Index. The information provided by the EndoPredict test will help patients choose, with their clinician, whether or not to pursue adjuvant chemotherapy.

07:03 EDT Mechel prolongs coal supply contract with China's Jidong Cement - Mechel reports prolonging the contract for coal supply with China's Jidong Cement, one of the world's top cement producers, until the end of 2019. According to the agreement, during this year Mechel will supply its Chinese partners up to two million tonnes of thermal coal mined at the company's South Yakutia facilities, Elgaugol OOO and Yakutugol Holding Company AO. Monthly supplies will vary from 100,000 to 150,000 tonnes of coal products. Prices will be adjusted on a monthly basis following negotiations and on the basis of index rates.

07:02 EDT Sanofi dengue vaccine Dengvaxia approved in Europe - The European Commission has granted marketing authorization for Dengvaxia, Sanofi's dengue vaccine. The marketing authorization follows the October 18, 2018, recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use to approve use of the dengue vaccine in European endemic areas.

06:58 EDT Teekay LNG authorizes $100M unit repurchase program - Teekay LNG's general partner Teekay GP has authorized a common unit repurchase program for the repurchase of up to $100M of Teekay LNG's common units. At the special meeting of common unitholders, all proposals, including the proposal to allow Teekay LNG to elect to be treated as a corporation, instead of a partnership, for U.S. federal income tax purposes, were approved by unitholders. As a result, effective January 1, 2019, Teekay LNG will be treated as a corporation for U.S. federal income tax purposes and common and preferred unitholders will receive Form 1099s instead of Schedule K-1s relating to distributions taxable as dividends commencing in 2019. Teekay LNG will remain a master limited partnership, and all other provisions of the Partnership's limited partnership agreement remain in effect.

06:35 EDT AC Immune, Wuxi Biologics establish strategic partnership - AC Immune (ACIU) and WuXi Biologics (WXXWY) announced the first steps of an exclusive strategic collaboration that covers biologics discovery, development and manufacturing. AC Immune and WuXi Biologics have entered into a memorandum of understanding governing the terms of a preferred partnership allowing AC Immune to leverage WuXi Biologics' capacities and capabilities in the manufacturing and supply of traditional and innovative New Biological Entities, or NBE, against disorders of the central nervous system, or CNS. Through this collaboration, AC Immune would have priority access to WuXi Biologics' proprietary platforms, including the bispecific antibody platform WuXiBody and WuXiUP continuous manufacturing platform. In addition, WuXi Biologics would become a preferred partner of AC Immune for bioprocess development, as well as manufacturing for discovery, pre-clinical and clinical supply of AC Immune's NBE pipeline. Under the same agreement, the companies would explore the use of AC Immune's platform to treat non-CNS diseases by identifying areas where AC Immune's antibody discovery platform could generate superior novel candidates. In addition, WuXi Vaccines, the vaccine arm of WuXi Biologics, would explore enabling the application of AC Immune's vaccine portfolio in China.

06:34 EDT Quarterhill's IRD awarded $1.35M contract in South Dakota - Quarterhill company International Road Dynamics, or IRD, has received of a contract from BX Civil & Construction to supply, install, and maintain a Weigh-in-Motion Sorting System at the Valley Springs Port of Entry on Interstate 90 east of Sioux Falls, South Dakota. The project is valued at $1.35M with installation to be completed by December 2019. The Port-of-Entry Commercial Vehicle WIM Sorting System protects highway infrastructure by weighing all commercial vehicles, capturing license plate numbers and directing suspected violators to report to the Truck Inspection Station.

06:13 EDT Sears to take $443M in charges from store closures - In a regulatory filing, Sears said it expects to incur charges of approximately $443 million, including $81 million in markdowns, $9 million in severance costs, $335 million in lease termination costs, $12 million in other charges, and $6 million in depreciation, in the third and fourth fiscal quarters of 2018 as a result of the store closures announced on October 15, 2018. The estimated amount for lease termination costs includes leases that may be rejected pursuant to the company's proceedings under chapter 11 of title 11 of the United States Code and is based on contractual future rent payments and does not include any adjustment to reduce the amount to the expected allowed claims as the damages from the possible rejection of such leases cannot currently be estimated.

06:05 EDT Avinger's Pantheris imaging system shows superiority in SCAN clinical study - Avinger released the preliminary analysis of results from its SCAN clinical study, a post-market study comparing optical coherence tomography with intravascular ultrasound as a diagnostic imaging tool in the peripheral arteries. Initial analysis of the SCAN data indicated that OCT imaging with Avinger's Pantheris System showed statistical superiority or equivalence to IVUS on all parameters evaluated. Preliminary data analysis from the reviewer rankings of the 240 images indicated that OCT imaging with Pantheris was significantly better than IVUS in visualizing plaque, calcification and stent struts. OCT imaging was ranked to be statistically equivalent to IVUS in visualizing the layered structures of the vessel wall and visualizing troughs following atherectomy. Avinger's proprietary Lumivascular technology utilizes OCT to provide real-time vascular imaging for the diagnosis and treatment of peripheral artery disease. The FDA has cleared both diagnostic and therapeutic treatment indications for use for Avinger's Pantheris and Ocelot image-guided catheters.

06:00 EDT Facebook removes hundreds more accounts linked to the Myanmar military - In a blog post published Tuesday night, Facebook said it took down 425 Pages and 150 additional Facebook and Instagram accounts "linked to the Myanmar military." At least 2.5 million people "followed at least one of these Facebook Pages," the company added. "We removed 425 Facebook Pages, 17 Facebook Groups, 135 Facebook accounts and 15 Instagram accounts in Myanmar for engaging in coordinated inauthentic behavior on Facebook. As part of our ongoing investigations into this type of behavior in Myanmar, we discovered that these seemingly independent news, entertainment, beauty and lifestyle Pages were linked to the Myanmar military, and to the Pages we removed for coordinated inauthentic behavior in Myanmar in August. This kind of behavior is not allowed on Facebook under our misrepresentation policy because we don't want people or organizations creating networks of accounts to mislead others about who they are, or what they're doing." Reference Link

05:49 EDT UPS expects number of packages returned to peak before Christmas - National Returns Day is expected to occur prior to Christmas, reflecting just how deeply e-commerce is reshaping the retail universe, according to UPS. Consumers who got a jump on online shopping in the days before Black Friday are expected to begin returning more than 1 million packages each day in December, jumpstarting the holiday returns season earlier than ever. The spike is driven by self-gifting due to retailer promotions, express shipping for deliveries and returns, simplified returns processes and advanced re-stocking and management systems. In past years, National Returns Day occurred in early January and represented the highest spike of packages for the entire year. Returns are still expected to hit 1.3 million packages on Jan. 3, but this will now represent the second wave and be outpaced by Dec. 19th returns of 1.5 million. These returns are included in the 800 million packages UPS anticipates delivering this holiday season.

05:46 EDT Bristol-Myers receives offer from Taisho to purchase UPSA for $1.6B - Bristol-Myers announced that Taisho Pharmaceutical Holdings has offered to purchase Bristol-Myers Squibb's UPSA consumer health business for $1.6B. UPSA develops and delivers important consumer medicines for patients in France, across Europe and additional countries. Taisho is the largest over-the-counter drug company in Japan, with over a century of experience in this field. Taisho holds a leading presence in anti-inflammatory analgesic, cold and flu and hair growth segments in Japan and Southeast Asia. The potential transaction is anticipated to be completed during the first half of 2019, subject to regulatory approvals and satisfaction of certain other customary closing conditions. The offer by Taisho is structured in the form of a "put option" agreement. Under the terms of the agreement, the offer is subject to Bristol-Myers Squibb's exercise of the put option following information and consultation processes with relevant employee representative bodies. Upon exercise of the put option, Bristol-Myers Squibb and Taisho would execute a definitive stock and assets purchase agreement following which Taisho would acquire all of the issued and outstanding shares of capital stock of UPSA SAS, as well as Bristol-Myers Squibb's assets and liabilities relating to the UPSA product portfolio. Assuming completion, Bristol-Myers Squibb estimates the potential transaction would be approximately (4c) dilutive to 2019 earnings.

05:37 EDT Pfizer, GSK to merge consumer healthcare units into joint venture - Pfizer (PFE) and GlaxoSmithKline (GSK) announced they have entered into an agreement to create a consumer healthcare company. The boards of both companies have unanimously approved the transaction under which Pfizer will contribute its consumer healthcare business to GlaxoSmithKline's existing consumer healthcare business. The 2017 global sales for the combined business were approximately $12.7B. Under the terms of the transaction, Pfizer will receive a 32% equity stake in the joint venture, entitling Pfizer to its pro rata share of the joint venture's earnings and dividends, which will be paid on a quarterly basis. Pfizer will have the right to appoint three out of the nine members of the joint venture's board. The transaction is expected to deliver $650M in peak cost synergies and to be slightly accretive for Pfizer in each of the first three years after the close of the transaction, which is anticipated during the second half of 2019, subject to receipt of GSK shareholder approval and regulatory approvals, and satisfaction of other customary closing conditions. Pfizer anticipates deconsolidating Pfizer Consumer Healthcare from its financial statements following the closing of the transaction. In the near- to medium-term, this deconsolidation is not expected to have a material impact on Pfizer's top-line growth. In addition, given the Consumer Healthcare business records lower margins than Pfizer's other businesses, the deconsolidation is expected to have a slight positive impact on Pfizer's operating margins over the next several years. Following the integration of the combined business, GSK intends to separate the joint venture as an independent company via a demerger of its equity interest to its shareholders and a listing of the Consumer Healthcare business on the UK equity market. GSK will have the sole right to decide whether and when to initiate a separation and listing for a period of five years from closing of the proposed transaction. GSK may also sell all or part of its stake in the joint venture in a contemporaneous IPO. Should a separation and listing occur during the first five years after closing, Pfizer has the option to participate through the distribution of its equity interest in the joint venture to its shareholders or the sale of its equity interest in a contemporaneous IPO. After the fifth anniversary of the closing of the proposed transaction, both GSK and Pfizer will have the right to decide whether and when to initiate a separation and public listing of the joint venture. The joint venture will operate globally under the GSK Consumer Healthcare name. Emma Walmsley, GSK CEO, will be Chair of the new joint venture. Brian McNamara, currently CEO GSK Consumer Healthcare, will be CEO of the new joint venture and Tobias Hestler, currently CFO GSK Consumer Healthcare, will be CFO. GSK has agreed to pay a break fee of $900M if the GSK board changes, withdraws or qualifies its recommendation of the transaction to its shareholders for approval or if its shareholders do not approve the transaction.

05:35 EDT Sandoz enters into commercialization, supply agreement for insulin biosimilars - Sandoz, a Novartis division, announced that it has entered into an agreement to commercialize biosimilar versions of insulins used in patients with type 1 and type 2 diabetes. These medicines are currently in early and clinical stages of development for the European Union, United States and other key territories. The commercialization and supply agreement with Gan & Lee aims at bringing to market biosimilar versions of glargine, lispro and aspart, the three top insulin medicines by sales. Gan & Lee is a leading insulin supplier headquartered in China with more than 20 years' experience in insulins and production capacity with attractive cost of goods sold structures. Under the terms of the agreement, Sandoz will be fully responsible for commercializing these medicines in the EU, U.S., Switzerland, Japan, South Korea, Canada, Australia and New Zealand. Gan & Lee will be responsible for manufacturing and development, with support from Sandoz, and shall adhere to the stringent manufacturing requirements established for Sandoz biosimilars. Other specific terms of the agreement are confidential.

05:31 EDT Pfizer, GlaxoSmithKline to create consumer healthcare joint venture

05:17 EDT JA Solar supplies modules for 3MW bifacial mono PERC solar project in Brazil - JA Solar announced that it will supply all bifacial mono PERC double glass modules for SolarGrid's 3MW solar power plant in Brazil. This is the country's first bifacial double glass solar project. Additionally, this project represents the entry of the company's bifacial PERC double glass modules into the Brazilian market, which, with the product's higher power output and better mechanical loading tolerance, is important in the development of green energy in the country. Additionally, the JA Solar bifacial PERC double glass modules used in this solar project are equipped with parallel single-axis trackers, which can highlight the advantages of electricity generation of the bifacial modules and substantially increase power output of the system. The solar plant is expected to generate 7.1 million KWh of electricity per year and reduce carbon dioxide emissions by 5,284 tons per year. Operating under the same environmental conditions, the JA bifacial mono PERC double-glass modules can generate electricity 9.5% higher compared to mono PERC single-sided modules.