Stockwinners Market Radar for December 17, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

AETI

Hot Stocks

20:02 EDT American Electric Tech enters into share exchange agreement with Stabilis - American Electric Technologies has executed a definitive share exchange agreement with privately-held Stabilis Energy and its subsidiaries to create one of the leading public small-scale liquefied natural gas production and distribution companies in North America. The combined business will include Stabilis' small-scale LNG production and distribution businesses as well as AETI's existing international businesses. At the closing, Stabilis and its subsidiaries will become wholly-owned subsidiaries of AETI and the existing AETI shareholders will own 11% of the combined company. The former owners of Stabilis will own 89% of the Combined Company. After closing, James Reddinger, current President and Chief Executive Officer of Stabilis, will serve as President and Chief Executive Officer of the Combined Company. Casey Crenshaw, the controlling shareholder of Stabilis, will serve as Executive Chairman.
ORCL...

Hot Stocks

19:06 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: Oracle Corp (ORCL) up 5.3%... Heico (HEI) up 0.9%. ALSO HIGHER: Marin Software (MRIN) up 50.7% after disclosing 3-year partnership with Google... Puma Biotech (PBYI) up 10.9% after disclosing Phase 3 NALA trial results... Smart Global Holdings (SGH) up 5.9% after announcing entry into S&P SmallCap 600 index... Boeing (BA) up 2.0% after announcing new $20B stock buyback and raising dividend by 20%... CBS (CBS) up 1.5% after the Board concluded that former CEO Moonves can be terminated for cause and denied $120M severance... Johnson & Johnson (JNJ) up 0.9% after announcing a $5B stock buyback... Royal Dutch Shell (RDS.A) up 0.9% after Bloomberg report that it is in talks to acquire Enveavor for about $8B... Marathon Oil (MRO) up 0.6% after being initiated at But at SunTrust... Barrick Gold (ABX) up 0.4% after receiving court approval to merge with Randgold and raising its dividend. ALSO LOWER: eHealth (EHTH) down 1.9% after mixed shelf offering... Achillion Pharma (ACHN) down 1.7% after disclosing interim data for ACH-4471 phase 2 trials.
CHGG

Hot Stocks

18:57 EDT Chegg's Schlein sells 34,750 common shares - In a regulatory filing, Chegg director Ted Schlein disclosed the sale of 34,750 common shares of the company at a price of $28.84 per share.
JNJ

Hot Stocks

18:30 EDT J&J CEO says $5B buyback reflects 'confidence' and 'conviction' - Johnson & Johnson CEO Alex Gorsky said in an interview on CNBC's "Mad Money" that the company's recent announcement of a $5B buyback is a reflection of "confidence" and "conviction" in the company and that he "can't be more excited" about J&J's future.
JNJ

Hot Stocks

18:24 EDT J&J CEO says he 'unequivocally' believes baby powder does not contain asbestos - Johnson & Johnson CEO Alex Gorsky said in an interview on CNBC's "Mad Money" that, in response to a Reuters report from last week that the company knew for decades about asbestos in its talc-based baby powder, the company "unequivocally" believes that its talc-based baby powder does not contain asbestos. Gorsky added that many studies, some conducted by J&J, support the company's claims. The CEO said that such studies were "independent" and involved nearly 100,000 patients, both men and women, for decades. Gorsky added that he remains "very confident" in the safety of J&J's products.
CBS

Hot Stocks

18:15 EDT CBS board determines there are grounds to terminate Moonves for cause - CBS' board of directors issued the following statement: "The Board of Directors of CBS has completed its investigation of former Chairman and CEO Leslie Moonves, CBS News, and cultural issues at CBS. With regard to Mr. Moonves, we have determined that there are grounds to terminate for cause, including his willful and material misfeasance, violation of Company policies and breach of his employment contract, as well as his willful failure to cooperate fully with the Company's investigation. Mr. Moonves will not receive any severance payment from the Company. As a result of their work, the investigators also concluded that harassment and retaliation are not pervasive at CBS. However, the investigators learned of past incidents of improper and unprofessional conduct, and concluded that the Company's historical policies, practices and structures have not reflected a high institutional priority on preventing harassment and retaliation. The investigation determined that the resources devoted to the Company's Human Resources function, to training and development, and to diversity and inclusion initiatives have been inadequate, given the size and complexity of CBS' businesses. Employees also cited past incidents in which HR and the Company did not hold high performers accountable for their conduct and protect employees from retaliation. The Board, which includes six new members, and the Company's new management have already begun to take robust steps to improve the working environment for all employees. Among other things, the Company appointed a new Chief People Officer, is actively engaged in ways to enhance and reimagine the Human Resources function, and has retained outside expert advisors to develop other initiatives for promoting a workplace culture of dignity, transparency, respect and inclusion. These efforts will continue to be a high priority for the Board and the Company's management, and we will continue to work together to communicate with our workforce in that regard."
EXK

Hot Stocks

18:10 EDT Endeavour Silver to cut production rate at El Cubo mine by about 50% in 2019 - Endeavour Silver provides an early review of its 2019 mine plan for the El Cubo mine, located in Guanajuato, Mexico. Due to the current short mine life at El Cubo, the company plans to reduce the production rate in 2019 to approximately half its 1500 tonne per day capacity, at higher operating costs than 2018, while continuing to explore for new reserves to extend the mine life. More details will be provided when Endeavour releases its 2019 consolidated production and cost guidance in January. Accordingly, the company has initiated layoffs of approximately 240 employees to reflect the lower production rate in 2019. The mine will continue to run at three shifts per day but the plant will move to one shift per day next year. Some idled mining equipment at El Cubo has been shipped to the El Compas mine in Zacatecas to facilitate their mine plan in 2019.
FGEN

Hot Stocks

18:08 EDT FibroGen says roxadustat approved in China for treatment of anemia - FibroGen announced that FibroGen Medical Technology Development Co., Ltd. has received marketing authorization from the National Medical Products Administration for roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of patients with anemia caused by chronic kidney disease in patients who are dialysis-dependent. The medicine can be prescribed to patients who use hemodialysis or peritoneal dialysis. Anemia caused by CKD is associated with cardiovascular disease, hospitalization, cognitive impairment, and reduced quality of life, and has been shown consistently to increase the mortality risk in patients with CKD. Anemia becomes increasingly common among individuals with CKD as their disease progresses, affecting nearly all patients at the dialysis-eligible stage.
ORCL

Hot Stocks

18:03 EDT Oracle rises after better-than-expected Q2 results - Shares of Oracle (ORCL) were on the rise after the company reported better-than-expected results for its fiscal second quarter. In addition, Oracle provided an earnings outlook for the third quarter that exceeds Wall Street expectations. EARNINGS: After the market close, Oracle reported Q2 adjusted earnings per share of 80c on revenue of $9.6B, compared to analysts' estimates of 78c and $9.52B, respectively. Cloud Services and License Support revenues for the quarter were $6.6B, while total Cloud Services and License Support plus Cloud License and On-Premise License revenues rose 1% in the quarter to $7.9B. Short-term deferred revenue in Q2 rose 3% year-over-year to $8.2B, the company added. Commenting on the results, Oracle CEO Safra Catz said that she is "confident" that the company will "continue to record strong EPS and free cash flow growth during the second half of this fiscal year." GUIDANCE: On its quarterly conference call, Oracle guided for Q3 adjusted EPS in constant currency in the range of 86c-88c on revenue growth of 2%-4%. Analysts expect the company to report Q3 EPS of 84c on revenue of $9.85B. The company noted on its call thatits Cloud apps business will "only strengthen from here" and said it expects second half revenue growth will be higher than in the first half. Oracle also guided for "double digit" EPS growth in fiscal 2019. PRICE ACTION: In after hours trading, Oracle shares are up 4.53% to $47.80.
BA

Hot Stocks

17:53 EDT Boeing jumps in after-hours trading after repurchase, dividend raise - Shares of aerospace firm Boeing (BA) are spiking in after-market trading, and are currently up more than 1.8% after the company announced would be replacing its existing share repurchase program with a new $20B authorization, raised from the $18B approved last December. This year, the company repurchased $9B worth of its shares from the $18B authorization approved in December 2017. Additionally, the company said it will be raising it's quarterly dividend by 20% to $2.055 per share from $1.71 per share. PRICE ACTION: Shares of Boeing are up 1.86% in after-hours trading to 322.00 per share.
GD

Hot Stocks

17:52 EDT General Dynamics awarded $335.04M Army contract - General Dynamics was awarded a $335.04M hybrid contract for mobile protected firepower middle tier acquisition and rapid prototyping effort with low-rate initial production options. Bids were solicited via the internet with three received. Work will be performed in Sterling Heights, Michigan, with an estimated completion date of October 15, 2025. FY18 and FY19 research, development, test and evaluation funds in the amount of $175.01M were obligated at the time of the award. U.S. Army Contracting Command is the contracting activity.
BAESY

Hot Stocks

17:49 EDT BAE Systems awarded $375.93M Army contract - BAE Systems was awarded a $375.93M hybrid contract for mobile protected firepower middle tier acquisition and rapid prototyping effort with low-rate initial production options. Bids were solicited via the internet with three received. Work will be performed in Sterling Heights, Michigan, with an estimated completion date of October 15, 2025. FY19 research, development, test and evaluation funds in the amount of $175.97M were obligated at the time of the award. U.S. Army Contracting Command is the contracting activity.
NOC

Hot Stocks

17:47 EDT Northrop Grumman awarded $3.6B Air Force contract for LAIRCM equipment, support - Northrop Grumman has been awarded a $3.6B indefinite-delivery/indefinite-quantity contract for large aircraft infrared counter measures, or LAIRCM, equipment and support. This contract provides for LAIRCM line replaceable units, support equipment, logistics support related activities, systems and sustaining engineering, program management, and other efforts necessary supporting efforts specified in each task/delivery order. Work will be performed in Rolling Meadows, Illinois, and is expected to be completed by December 2025. No funds are being obligated at the time of award. This contract involves numerous foreign military sales requirements and is the result of a sole-source acquisition. Air Force Life Cycle Management Center is the contracting activity.
JNJ

Hot Stocks

17:46 EDT Johnson & Johnson up over 1% after announcing buyback, affirming FY18 EPS view
NUS

Hot Stocks

17:40 EDT Nu Skin adopts restructuring program, sees pre-tax charges of about $70M in Q4 - According to a regulatory filing, on December 12, 2018, Nu Skin Enterprises, Inc. adopted a restructuring program. This program is a strategic plan to align the company's resources and capabilities to support its vision of being a "world-leading business platform," it said. "We believe that this restructuring program will accelerate our ability to achieve our future growth objectives and priorities," the company said. "It primarily impacts our information technology infrastructure and organization and other departments within our corporate and Americas offices. We expect that the actions contemplated under the restructuring program will be substantially completed by December 31, 2018. We estimate that the implementation of the restructuring program will result in pre-tax charges of approximately $70M in the fourth quarter of 2018, consisting primarily of non-cash charges for the impairment of information technology infrastructure, including internally developed software, of approximately $50M and the balance related to severance payments and other related expenses. The company determined that the impairment charge was required on December 13, 2018. These charges were not reflected in our previously announced 2018 fourth-quarter or full-year financial guidance."
CNXN

Hot Stocks

17:37 EDT Connection announces special dividend of 32c per share - The dividend is payable on January 11, 2019, to shareholders of record at the close of business on December 28, 2018.
CNXN

Hot Stocks

17:37 EDT Connection approves new $25M stock buyback - Connection announced that its board of directors approved a new share repurchase program authorizing up to $25M in share repurchases. There is no fixed termination date for this new repurchase program.
ORCL

Hot Stocks

17:29 EDT Oracle up 5% to $48.05 after Q2 results, Q3 guidance beat estimates
ORCL

Hot Stocks

17:23 EDT Oracle says Cloud apps business 'to only strengthen from here'
SGH XOXO

Hot Stocks

17:18 EDT Smart Global to replace XO Group in S&P 600 at open on 12/24 - WeddingWire is acquiring XO Group in a deal expected to be completed soon pending final approvals
ORCL

Hot Stocks

17:15 EDT Oracle sees 2H revenue growth higher than 1H - Sees FY19 tax rate ~20%.
ORCL

Hot Stocks

17:12 EDT Oracle says Q2 'another solid quarter' - Says expects gross margins to increase as Cloud business scales. Comments from company's Q2 earnings conference call.
VLGEA

Hot Stocks

17:11 EDT Village Super Market appoints co-presidents, Robert Sumas will remain CEO - On December 14, the Village Super Market board appointed Nicholas Sumas and John J. Sumas as Co-Presidents. Robert Sumas will remain CEO. In connection with these appointments, the positions of Chief Marketing Officer and Chief Operating Officer will be eliminated. Nicholas Sumas has served as Chief Marketing Officer since 2014, Vice President from 2007 through 2014 and has been a Director of the company since 2009. John J. Sumas has served as COO since 2014, Vice President from 2007 through 2014 and has been a Director of the Company since 2009. John J. Sumas will remain the company's General Counsel, a role he has served since 2007.
FCPT

Hot Stocks

17:09 EDT Four Corners Property Trust acquires six Red Lobster properties for $25.9M - Four Corners Property Trust announced the acquisition of six Red Lobster restaurant properties in Delaware, Indiana, Kentucky, Minnesota, Mississippi and North Dakota for $25.9M. The six newly acquired properties are under a single, triple-net master lease which includes two other Red Lobster properties previously acquired by FCPT in November 2017. The 8-unit master lease has approximately 21 years of term remaining and annual rent escalations of 2.0%. The transaction was priced at a similar going-in cash capitalization rate as previously announced transactions. Red Lobster operates over 700 restaurants across the country and is the largest casual dining seafood brand in the U.S. Bill Lenehan, CEO of FCPT, stated, "This transaction marks over $510M in closed deals since our investment platform launched in July 2016. To date, FCPT has closed $449M of acquisitions across 197 properties and sold seven Darden-leased properties for $63M."
GMS

Hot Stocks

17:08 EDT GMS Inc.'s Ross acquires 100,000 common shares - In a regulatory filing, GMS director Ronald R. Ross disclosed the purchase of 100,000 common shares of the company in two transactions of 50,000 shares each. The first transaction was bought at $15.2895 per share, while the second was bought at $16.0209 per share.
CP

Hot Stocks

17:05 EDT Canadian Pacific chairman Reardon to retire from board - Andrew F. Reardon has notified Canadian Pacific Railway Limited that he will be retiring from CP's board of directors as of CP's 2019 Annual General Meeting on May 7, 2019. Isabelle Courville, a current member of the board, has been designated by the board as its next chair. Reardon has been a director of CP since May 1, 2013 and chairman of the board since July 20, 2015.
MRIN

Hot Stocks

17:04 EDT Marin Software up over 13% afterhours on Google partnership announcement
MRIN GOOGL

Hot Stocks

17:02 EDT Marin Software announces 3-year revenue sharing agreement with Google - Marin Software (MRIN) announced that it has entered into a three-year revenue sharing agreement with Google (GOOGL) to further develop Marin's enterprise tech platform and software products. The agreement with Google extends through September 30, 2021, at which time the agreement may be terminated or renewed. Future guidance from Marin will incorporate all expected revenues and reinvestments required under this agreement.
IRET

Hot Stocks

17:01 EDT IRET announces 1-for-10 reverse stock split - IRET announced that its board of trustees approved a 1-for-10 reverse stock split of its outstanding shares. The reverse stock split is scheduled to take effect after the market closes on December 27, 2018. IRET's common shares are expected to begin trading on a split-adjusted basis on December 28, 2018. At the Effective Time, every ten issued and outstanding shares of common stock of IRET will be converted into one common share of IRET. Trading in the common stock will continue on the NYSE under the symbol "IRET," but the security will be assigned a new CUSIP number. Pursuant to the previous announcement on September 20, 2018, IRET's Board of Trustees approved a change in its fiscal year-end from April 30 to December 31. IRET will file a transition report on Form 10-K for the period ended December 31, 2018, in accordance with SEC rules and regulations. All subsequent fiscal years for IRET will be from January 1 to December 31, beginning in 2019.
RP

Hot Stocks

16:56 EDT RealPage VP William Chaney sells 3,000 shares of company stock - RealPage VP William Chaney disclosed in a regulatory filing that he sold 3,000 shares of company stock at an average price of $51.01 per share on December 13. The total transaction value of the sale was $153,030.
ABX

Hot Stocks

16:50 EDT Barrick Gold raises quarterly dividend to 4c from 3c per share - Barrick Gold announced that its board has declared a dividend for the fourth quarter of 2018 of 7c per share, payable on January 14, 2019, to shareholders of record at the close of business on December 28, 2018. This will result in an annual dividend of 16c per share paid to the shareholders of Barrick in respect of the 2018 financial year. Following the completion of Barrick's merger with Randgold Resources Limited, the Company expects to pay a quarterly dividend of 4c per share, commencing with the dividend to be declared in April 2019 in respect of the first quarter of 2019.
ALL

Hot Stocks

16:46 EDT Allstate enters $1B share buyback pact with Wells Fargo - In a regulatory filing, Allstate said that on December 14, 2018, it entered into an accelerated share repurchase agreement with Wells Fargo Bank, National Association, to purchase $1B of its outstanding common stock. The majority of the shares to be repurchased under this agreement will be received by Allstate at the agreement's inception. It is expected that Wells Fargo will purchase the shares that it delivers under the agreement in the market no later than May 3, 2019. The final purchase price per share and number of shares to be delivered by Wells Fargo will be determined at the conclusion of the agreement and settlement will consist of the company receiving shares based on the average of the daily volume weighted average prices of the company's common stock during the period of Wells Fargo's purchases. If the company is required to pay a settlement amount, the company may settle in shares of its common stock or, under certain circumstances, may elect to settle in cash. All of the shares acquired by Allstate under the agreement will be placed into its treasury. The agreement is part of Allstate's repurchase program totaling $3B that was announced on October 31, 2018. Excluding repurchases under this agreement, during 2018 the Registrant has repurchased 14.2M common shares in total as of December 13, 2018, for an aggregate amount of $1.35B.
MLND

Hot Stocks

16:42 EDT SHAM Innovation reports 5.3% passive stake in Millendo Therapeutics
PAH

Hot Stocks

16:39 EDT Platform Specialty Products chairman Martin Franklin buys $2.2M in shares - Platform Specialty Products chairman Martin Franklin disclosed in a filing that he had purchased 200,000 shares of company stock at an average price of $10.96 per share on December 14. The total transaction value of the purchase was $2,192,000.
LMB

Hot Stocks

16:37 EDT Limbach Holding approves 10b5-1 plans submitted by senior management - Limbach Holdings announced the company's Board of Directors has approved 10b5-1 share purchase plans submitted by the CEO, Charlie Bacon, and an additional member of Senior management. Pursuant to the plan, open market purchases of LMB shares will be made, subject to certain pre-defined conditions.
LMB

Hot Stocks

16:36 EDT Limbach Holding names Michael McCann as Co-COO - The company's Board of Directors approved the appointment of Michael McCann as Co-COO, effective as of January 1, 2019. McCann, an employee since 2010, has successfully operated other business units within Limbach Holdings and is now taking on additional responsibilities including operational oversight as the business continues to grow through both organic and acquisition initiatives. Kris Thorne remains the other COO within the business.
GRA

Hot Stocks

16:36 EDT W.R. Grace will continue program to raise FCC catalyst prices by 3%-9% in 2019 - W.R. Grace stated that it will continue its previously announced program to increase prices for its Fluid Catalytic Cracking catalysts by 3%-9% in 2019 based on product type and specific customer commitments. "We will continue pricing actions necessary to sustain our on-going investment in next-generation products, enhanced technical services, and leading manufacturing capabilities to serve our global customers," said Tom Petti, Grace's President, Refining Technologies. "Grace remains focused on mitigating the impact of escalating raw materials costs and controlling expenses." Grace continues to experience strong demand for its premium FCC catalysts technologies as refiners around the world work to optimize FCC unit profitability by maximizing petrochemical and alkylate feedstocks and processing more challenging crudes.
CLXT CLLS

Hot Stocks

16:35 EDT Calyxt receives EU patent for use of CRISPR/Cas9 for genome editing - Calyx (CLXT) announced the issuance of European patent number 3008186, which claims methods to create gene-edited plants by the transient delivery of sequence-specific nucleases, including CRISPR/Cas9. This patent, granted by the European Patent Office, is owned by Cellectis and licensed exclusively to Calyxt (CLLS).
AUTO

Hot Stocks

16:35 EDT AutoWeb appoints new CFO, CTO - AutoWeb appointed J.P. Hannan as executive VP, CFO and Tim Branham as senior VP, Chief Technology Officer, effective December 17. Hannan succeeds interim CFO Wes Ozima, who will remain at AutoWeb in his prior role as senior VP, controller, and Branham will be assuming a newly created position at the company.
ABX GOLD

Hot Stocks

16:33 EDT Barrick announces Jersey Court approval of merger with Randgold - Barrick Gold (ABX) announced that the Royal Court of Jersey has sanctioned the scheme of arrangement by which the recommended share-for-share merger of Barrick and Randgold (GOLD) is being implemented. All conditions of the scheme have now been satisfied or waived, and the merger is expected to close on January 1, 2019, following the delivery of a copy of the court order to the Jersey Registrar. Barrick intends to change its ticker symbol on the New York Stock Exchange from "ABX" to "GOLD" beginning on the merged company's first day of trading on January 2, 2019. GOLD is currently the ticker symbol for Randgold American Depositary Shares traded on the NASDAQ exchange. Barrick will continue to trade on the Toronto Stock Exchange under the ticker symbol "ABX" following the completion of the merger.
FLXN

Hot Stocks

16:32 EDT Flexion submits supplemental NDA for ZILRETTA - Flexion Therapeutics announced it submitted a supplemental new drug application to the U.S. Food and Drug Administration to revise the product label for ZILRETTA. The sNDA is based on data from an open-label Phase 3b clinical trial, which indicated that repeat administration of ZILRETTA for treatment of osteoarthritis knee pain was safe and well tolerated with no deleterious impact on cartilage or joint structure observed through X-ray analysis. The primary endpoint of the Phase 3b single-arm, open-label trial was the safety and tolerability of repeat administration of ZILRETTA in patients with symptomatic OA of the knee. The patients enrolled in the study generally had longstanding and extensive disease, with more than two-thirds of the participants presenting with Kellgren-Lawrence Grade 3 or Grade 4, the most radiographically severe form of OA. Participants received an initial intra-articular injection of ZILRETTA followed by evaluation at Weeks 12, 16, 20 and 24 to determine their eligibility for a second injection. In the trial, 95% of patients experienced clinical benefit after initial injection of ZILRETTA and 92% of these patients received a second injection on or after Week 12. The median time to a second injection was 16.6 weeks, with 74% of patients receiving their second administration of ZILRETTA between Weeks 16 and 24. There were no serious adverse events related to ZILRETTA reported during the trial, and the patterns of treatment emergent adverse events were consistent with those reported in previous clinical studies of ZILRETTA. An analysis of X-rays taken at baseline and Week 52 showed no harmful effects on cartilage or joint structure, as no incidences of chondrolysis, osteonecrosis, insufficiency fractures or clinically significant subchondral bone changes were observed. The trial also indicated that the magnitude and duration of pain relief experienced by patients after both the first and second injections was similar to results from the pivotal Phase 3 trial.
WHR

Hot Stocks

16:31 EDT Whirlpool Chairman Jeff Fettig to retire, CEO Marc Bitzer to succeed - Whirlpool Chairman Jeff Fettig announced that he will retire from the company on December 31, 2018 after 38 years of service. The Board of Directors has elected CEO Marc Bitzer to succeed Fettig as Chairman of the Board, effective January 1, 2019.
BMY

Hot Stocks

16:31 EDT Bristol-Myers, Boston Medical Center announce I-O research collaboration - Bristol-Myers Squibb and Boston Medical Center announced a multi-year joint research study to identify and analyze potential sensitivity and resistance markers in patients treated with standard-of-care checkpoint inhibitors. The comprehensive, multi-dimensional study will place an emphasis on uncovering mechanisms associated with lack of response to Immuno-Oncology therapies, with the ultimate goal of identifying prognostic and potentially predictive I-O biomarkers in a variety of cancers. Through the study, researchers will explore the role of tissue and circulating biomarkers on treatment sensitivity and resistance. In addition, scientists will investigate the role of the microbiome as a potential predictive biomarker in patients receiving treatment with immune checkpoint inhibitors. The two organizations will jointly conduct the research throughout the duration of the study, after which Bristol-Myers Squibb and Boston Medical Center may collaborate to publish results. Bristol-Myers Squibb opened its Cambridge R&D site, located in Kendall Square, on November 26, 2018.
FATE

Hot Stocks

16:31 EDT Fate Therapeutics director Amir Nashat sells 17,788 shares of company stock - Fate Therapeutics director Amir Nashat disclosed in a filing that he sold 17,788 shares of company stock at an average price of $16.67 per share on /December 13. The total transaction value was $296,563.
LMB

Hot Stocks

16:30 EDT Limbach Holding director Gellman resigns - Limbach Holdings announced the resignation of David S. Gellman from its board of directors and all committees of the board of directors on which he serves. Gellman leaves Limbach's board in order to focus more fully on other business interests. The Nominating & Governance Committee of the board intends to immediately move forward with a selection process to fill Gellman's seat, with the intention of selecting a new member with the experience to provide guidance to support the company's growth plans.
DOOR

Hot Stocks

16:27 EDT Masonite CEO Fred Lynch to retire by end of 2Q19 - Masonite announced that Fred Lynch plans to retire as President and CEO of the company by the end of the second quarter of 2019. Lynch also plans to leave the company's Board of Directors in connection with his retirement. As part of Masonite's succession planning, Masonite's Board of Directors has initiated a process to identify a successor to Lynch, which will consider both internal and external candidates. Spencer Stuart has been engaged to assist with the process. In order to ensure an orderly transition, Lynch is expected to remain in his current positions until the appointment of his successor.
BA

Hot Stocks

16:27 EDT Boeing raises quarterly dividend by 20% to $2.055 per share from $1.71 per share - The new dividend will be payable March 1, 2019, to shareholders of record as of Feb. 8, 2019.
BA

Hot Stocks

16:26 EDT Boeing announces new $20B share repurchase program - The Boeing board replaced the existing share repurchase program with a new $20B authorization, up from the $18B approved last December. This year, the company repurchased $9 billion worth of its shares from the $18 billion authorization approved in December 2017.
EYPT NBI

Hot Stocks

16:24 EDT EyePoint added to Nasdaq Biotechnology Index - EyePoint Pharmaceuticals (EYPT) announced that it has been selected for addition to the NASDAQ Biotechnology Index (NBI). EyePoint's addition to the NBI will become effective prior to market open on Monday, December 24, 2018.
JNJ

Hot Stocks

16:23 EDT Johnson & Johnson announces $5B share repurchase program - Johnson & Johnson announced that the Board of Directors has authorized the repurchase of up to $5B of the company's common stock. "Based on our continued strong performance and, more importantly, the confidence we have in our business going forward, the Board of Directors and management team believe that the company's shares are an attractive investment opportunity," said Alex Gorsky, Chairman and Chief Executive Officer. "Our strong cash flow enables us to simultaneously return value to shareholders through our regular quarterly dividend and share repurchases, while at the same time continuing to deploy capital that will further strengthen our robust enterprise pipeline and drive long-term growth."
RHT IBM

Hot Stocks

16:23 EDT Red Hat reports Q3 infrastructure related subscription revenue up 8% at $534M - Due to the pending transaction with International Business Machines (IBM), Red Hat will not be updating its outlook for fiscal 2019 and will not be hosting a conference call for its third quarter 2019 business results.
GLPG

Hot Stocks

16:23 EDT Galapagos NV initiates ISABELA Phase 3 program - Galapagos NV announced that it has dosed its first patient in the worldwide ISABELA Phase 3 program with autotaxin inhibitor GLPG1690 in IPF. "Today's news again demonstrates our commitment to the rapid advancement of our IPF franchise, including the ISABELA and the PINTA trials. We are excited by the feedback received from participating sites and KOLs, which underscores the need for novel treatments to address the remaining high unmet need in IPF," said Galapagos Chief Medical Officer Dr. Walid Abi-Saab.
SFBS

Hot Stocks

16:21 EDT ServisFirst raises quarterly dividend 36% to 15c from 11c per share - The dividend is payable on January 11, 2019 to stockholders of record as of January 2, 2019. ServisFirst has increased its dividend annually since the company went public in 2014.
BKH

Hot Stocks

16:21 EDT Black Hills requests renewable tariffs, approval for $57M wind project - Black Hills Corp. announced its Black Hills Energy electric utility subsidiaries in South Dakota and Wyoming filed for approval of new, voluntary renewable energy tariffs to serve customer requests for renewable energy resources. In addition, Black Hills Energy South Dakota and Wyoming electric utilities filed a joint application with the Wyoming Public Service Commission for a certificate of public convenience and necessity to construct a new $57M, 40-megawatt wind generation project near Cheyenne, Wyoming.
SPAR

Hot Stocks

16:19 EDT Spartan Motors adopts 10b5-1 trading plan for share repurchases - Spartan Motors announced that the company has entered into a 10b5-1 trading plan that authorizes share repurchases to begin Friday, December 21, subject to the terms and limits of the plan. Repurchases made under the plan are subject to the SEC's regulations, as well as certain price, market, volume, and timing constraints specified in the plan. Since repurchases under the plan are subject to certain constraints, there is no guarantee as to the exact number of shares that will be repurchased under the plan. This plan has been established pursuant to the previously-announced authorization by the company's Board of Directors for the company to repurchase up to 1M shares.
UBP

Hot Stocks

16:19 EDT Urstadt Biddle Properties Inc. chairman Charles J. Urstadt to step down - Charles J. Urstadt, chairman of the board of directors of Urstadt Biddle Properties Inc., will step down as chairman effective January 1, 2019, having served in that capacity since 1986. Urstadt joined the company as a director in 1975 and served as Chief Executive Officer from 1989 to 2013. The board of directors has appointed Charles D. Urstadt to succeed Charles J. Urstadt as chairman of the board of directors.
UHS

Hot Stocks

16:17 EDT Universal Health authorizes $500M increase to share repurchase program - Universal Health Services announced that its Board of Directors authorized a $500M increase to its stock repurchase program. This authorization will increase the aggregate authorization to $1.7B from the previous $1.2B authorization, which was approved in 2014, 2016 and 2017. Since the inception of this program, we have repurchased approximately 10M shares at an aggregate cost of approximately $1.16B.
KR

Hot Stocks

16:16 EDT Kroger announces succession plan for CFO J. Michael Schlotman - The Kroger Co. announced its succession plan for CFO. J. Michael Schlotman, Kroger's CFO since 2000, has decided to retire in December of 2019. Schlotman will continue as CFO through the end of Kroger's fiscal 2018 and up to April 3, 2019. He will then remain an executive vice president of the company and continue to sit on the senior leadership team to support the company during this transition period until December 28, 2019. Gary Millerchip, CEO of Kroger Personal Finance, will succeed Schlotman as Senior Vice President and CFO of Kroger, effective April 4, 2019.
EBS

Hot Stocks

16:13 EDT Emergent BioSolutions receives Health Canada approval for anthrax vaccine NDS - Emergent BioSolutions announced that Health Canada has approved the company's new drug submission, or NDS, for its anthrax vaccine, BioThrax. BioThrax is indicated for active immunization for the prevention of disease caused by Bacillus anthracis, in individuals 18 through 65 years of age, whose occupation or other activities place them at risk of exposure, regardless of the route of exposure. BioThrax is administered in a three-dose primary schedule with boosters at three-year intervals recommended thereafter. BioThrax was approved under the extraordinary use new drug regulations, which provide a regulatory pathway for products for which collecting clinical information for its intended use in humans is logistically or ethically not possible. BioThrax is designated by Health Canada as an innovative drug giving it market exclusivity for eight years. Earlier this year, Emergent completed the mutual recognition procedure for BioThrax expanding licensure of BioThrax in five European countries, namely, the U.K., Poland, France, Italy and the Netherlands, in addition to Germany, where BioThrax received market authorization in 2013.
ZAYO

Hot Stocks

16:12 EDT Zayo to expand East Coast data center presence - Zayo Group Holdings, Inc. will expand its East Coast data center presence with a new location in Piscataway, New Jersey. The carrier-neutral facility will add more than 47,000 total square feet and up to five megawatts of critical power, addressing strong demand for colocation in the tri-state area. The anchor agreement with a leading financial services tenant includes space and power in the data center and two dark fiber rings. Zayo will renovate the remaining space and upgrade critical power to sell to additional customers. The facility tethers to Zayo's data center at 165 Halsey St. in Newark and includes connectivity to local carrier hotels and more than 1,000 data centers globally.
SPAR

Hot Stocks

16:11 EDT Spartan Motors acquires Strobes-R-Us, terms not disclosed - Spartan Motors announced it has acquired Strobes-R-Us, a Florida-based, premier provider of upfit services for government and non-government vehicles. The acquisition will enable Spartan Motors to increase its product offerings to both fleet and emergency response customers, while further expanding its manufacturing capabilities into the southeastern U.S. market. As part of this acquisition, Spartan acquired Strobes-R-Us' state-of-the-art upfit facility and product showroom in Pompano Beach, Florida.
ORCL

Hot Stocks

16:08 EDT Oracle reports Q2 adjusted operating margin 43%
OTEX

Hot Stocks

16:07 EDT OpenText completes acquisition of Liaison Technologies - OpenText announced it has completed the closing of its previously announced acquisition of Liaison Technologies. The purchase price is approximately $310M in an all-cash transaction. Liaison is expected to contribute insignificant revenue to OpenText's results for the second quarter ending December 31, 2018, given that the transaction has closed during the holidays. Liaison is expected to be on the OpenText target operating model within the first twelve months after closing.
ANFI

Hot Stocks

16:07 EDT Amira Nature Foods receives continued listing standard letter from NYSE - Amira Nature Foods announced that New York Stock Exchange Regulation, Inc. by letter dated November 16, 2018 notified the company that its Ordinary Shares did not satisfy one of the standards for continued listing on the NYSE. The NYSE requires a listed company's stock to maintain an average closing price per share in excess of $1.00 for a consecutive 30-trading-day period. As of November 13, 2018, the average closing price per share of the company's Ordinary Shares over the preceding 30-trading-day period was $0.99.
SCVL

Hot Stocks

16:07 EDT Shoe Carnival announces new $50M stock buyback program - Shoe Carniva announced that its board authorized a new share repurchase program for up to $50 million of its outstanding common stock, effective January 1, 2019. The new share repurchase program will replace the existing $50 million share repurchase program that was authorized on December 14, 2017, which will expire in accordance with its terms on December 31, 2018. There is currently $4.0 million that remains authorized for repurchases under the existing share repurchase program. Additional purchases may be made under the existing share repurchase program prior to its expiration.
PBYI

Hot Stocks

16:06 EDT Puma Biotechnology reports top-line results from Phase III NALA trial - Puma Biotechnology, Inc. announced top line results from the Phase III NALA trial of the company's lead drug candidate PB272 in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments in the setting of metastatic disease. The Phase III NALA trial is a randomized controlled trial of neratinib plus capecitabine versus Tykerb plus capecitabine in patients with third-line HER2-positive metastatic breast cancer. The trial enrolled 621 patients who were randomized to receive either neratinib plus capecitabine or lapatinib plus capecitabine. The trial was conducted globally at sites in North America, Europe, Asia-Pacific and South America. The co-primary endpoints of the trial are centrally confirmed progression free survival and overall survival. An alpha level of 1% was allocated to the PFS and 4% allocated to OS. The study was to be considered positive if either of the co-primary endpoints was positive. Puma reached agreement with the U.S. Food and Drug Administration under a Special Protocol Assessment for the design of the Phase III clinical trial and the European Medicines Agency also provided follow-on scientific advice consistent with that of the FDA regarding the company's Phase III trial design and endpoints used in the trial. For the primary analysis of centrally confirmed PFS, treatment with neratinib plus capecitabine resulted in a statistically significant improvement in centrally confirmed PFS compared to treatment with lapatinib plus capecitabine. For the primary analyses of OS, neratinib plus capecitabine resulted in an improvement in OS that did not achieve statistical significance but trended positively in favor of the neratinib plus capecitabine arm of the study. For the secondary endpoint of time to intervention for symptomatic central nervous system disease, the results of the trial showed that treatment with neratinib plus capecitabine led to an improvement over the combination of lapatinib plus capecitabine. The safety profile of neratinib in the Phase III NALA study was consistent with previous clinical trials of neratinib. Full results of the trial will be submitted to health authorities around the world, including the U.S. Food and Drug Administration and European Medicines Agency. Results of the trial will be submitted for presentation at a major medical conference in 2019.
ORCL

Hot Stocks

16:06 EDT Oracle CEO Catz says 'confident' in continuing strong EPS growth in 2H - "In Q2, non-GAAP earnings per share grew 19% in constant currency," said Oracle CEO, Safra Catz. "In addition to our strong EPS growth, free cash flow grew 10% to $13.8 billion over the previous twelve months. I am confident that we will continue to record strong EPS and free cash flow growth during the second half of this fiscal year." "Oracle's two cloud ERP businesses, Fusion ERP and NetSuite ERP, delivered a combined revenue growth rate of 32% in Q2," said Oracle CEO, Mark Hurd. "With nearly 6,000 Fusion ERP customers and over 16,000 NetSuite ERP customers, Oracle is the clear leader in cloud ERP. ERP has always been the largest segment of the enterprise applications business, so we have lots of room to grow as customers migrate from their traditional on-premise ERP to the Oracle Fusion ERP Cloud." "The Oracle Autonomous Database for data warehousing and transaction processing is the world's only self-driving database," said Oracle CTO, Larry Ellison. "The Oracle Autonomous Database lowers costs by eliminating human labor and increases reliability by eliminating human error. And Oracle is the only database that automatically patches and upgrades itself while running."
KMI

Hot Stocks

16:06 EDT Kinder Morgan approves $49M investment in Plantation Pipe Line System - Kinder Morgan announced a successful open season on its Roanoke Expansion projects on the Plantation Pipe Line System. Following the open season, Plantation Pipe Line secured long-term committed volumes of 20,000 barrels per day (bpd). The Plantation Pipe Line Company's investment in the project is approximately $49 million. In addition, Kinder Morgan Southeast Terminal's investment, fully backed by 10,000 bpd of long-term committed volumes, is approximately $9 million. With the successful open season, Plantation Pipe Line will submit the Petition for Declaratory Order to the Federal Energy Regulatory Commission for approval of commercial terms for the project. Pending all regulatory approvals, the project is expected to be in full service by April 1, 2020. The Plantation Pipe Line Roanoke Expansion will provide approximately 21,000 bpd of incremental refined petroleum products capacity on Plantation from the Baton Rouge, Louisiana, and Collins, Mississippi, origin points to the Roanoke, Virginia, area. The expansion will primarily consist of additional pump capacity and operational storage on the Plantation system.
ACRS

Hot Stocks

16:05 EDT Aclaris Therapeutics provides update on three clinical trials for ATI-502 - Aclaris Therapeutics provided updated data from three clinical trials for ATI-502, an investigational topical Janus kinase, or JAK, 1/3 inhibitor, an update on the expected release of topline data for one clinical trial for ATI-502, and an enrollment update for a clinical trial for ATI-501, an investigational oral JAK 1/3 inhibitor. AA-202 Topical and AUATB-201 Topical are ongoing Phase 2 clinical trials of ATI-502 for the treatment of alopecia areata, or AA, in the United States and Australia, respectively. In AA-202 Topical, 11 patients with the more severe forms of AA, alopecia universalis, or AU, and alopecia totalis, or AT, were treated with ATI-502 in an initial double-blind pharmacokinetic and pharmacodynamic study for 28 days before entering a 12-month open-label extension. In AUATB-201 Topical, an open-label clinical trial, 12 patients with eyebrow loss due to AA, including patients with AU or AT, had their eyebrows treated with ATI-502 for 6 months. VITI-201 Topical is an open-label pilot clinical trial of ATI-502 administered twice daily in 34 patients with non-segmental facial vitiligo. As announced in November, Aclaris completed enrollment of AA-201 Topical, a randomized, double-blinded, parallel-group, placebo-controlled trial to evaluate the safety, efficacy and dose response of two concentrations of ATI-502 for the treatment of AA. This trial enrolled 129 patients with patchy AA, who were randomized to receive either ATI-502 or placebo. The primary efficacy endpoint is the mean change from baseline in the severity of Alopecia tool, or SALT, score at Week 24. Topline data from the AA-201 Topical trial are now expected in Q2 of 2019. In addition, Aclaris announced that it has completed enrollment of AUAT-201 Oral, a randomized, double-blinded, parallel-group, placebo-controlled trial to evaluate the safety, efficacy and dose response of three concentrations of ATI-501 oral suspension for the treatment of AA. This trial enrolled 87 patients with AA, including AT and AU, who were randomized to receive either ATI-501 or placebo. The primary efficacy endpoint is the mean change from baseline in the SALT score at Week 24. Topline data from the AUAT-201 Oral trial are now expected in Q3 of 2019.
ORCL

Hot Stocks

16:05 EDT Oracle reports Q2 short-term deferred revenue $8.2B, up 3% y/y - Short-term deferred revenues were up 3% to $8.2B compared to a year ago. Operating Cash Flow was up 5% to $15.2B during the trailing twelve months.
ACHN

Hot Stocks

16:05 EDT Achillion reports positive interim data for ACH-4471 Phase 2 trials - Achillion Pharmaceuticals reported interim results for the Company's Phase 2 trials of its first-generation oral factor D inhibitor, ACH-4471, as well as Phase 1 pharmacokinetics and potency data for its next-generation factor D inhibitors, ACH-5228 and ACH-5548. "These compelling findings underscore the momentum for Achillion and our factor D portfolio as we advance three oral small molecule compounds through clinical development. Our oral factor D inhibitors have the potential to treat patients suffering from alternative pathway mediated diseases," said Joe Truitt, President and Chief Executive Officer at Achillion. "In C3G, we have completed patient dosing in our 14-day biomarker/dose ranging study and we are currently enrolling patients in our 6 and 12-month PoC trials. We now have 18 clinical sites open globally and plan to open additional sites in 2019. We are also delighted that the FDA has recently agreed to allow adolescents in our trials as C3G is a disease with unmet medical needs that often begins in childhood. Our C3G plan is to enroll up to 20 patients in our 6 and 12-month trials and to present our data to the FDA at an End of Phase 2 meeting in Q4 2019."
ORCL

Hot Stocks

16:04 EDT Oracle reports Q2 Cloud Services and License Support revenues $6.6B - Total Cloud Services and License Support plus Cloud License and On-Premise License revenues were up 1% to $7.9B. Cloud Services and License Support revenues were $6.6B, while Cloud License and On-Premise License revenues were $1.2B.
SMRT

Hot Stocks

16:03 EDT Stein Mart appoints James Brown CFO - Stein Mart announced the appointment of James Brown as executive VP and CFO, effective December 17. Brown joins Stein Mart from Adrianna Papell Group, where he was CFO.
FBIZ

Hot Stocks

16:03 EDT First Business Financial board approves $5M share repurchase program - First Business Financial Services announced that the board has approved a stock repurchase program for the Company. The program authorizes the repurchase by the Company of up to $5 million of its total outstanding shares of common stock over a period of approximately twelve months, ending on December 31, 2019.
LGND

Hot Stocks

16:02 EDT Ligand acquires milestone, royalty rights to PTX-022 from Palvella - Ligand Pharmaceuticals Incorporated announced the acquisition of economic rights to PTX-022 from Palvella Therapeutics. PTX-022 is a novel, topical formulation of rapamycin currently in Phase 2/3 development for the treatment of pachyonychia congenita, a rare skin disorder for which no FDA-approved treatment exists. Ligand will pay $10M to Palvella Therapeutics and in return will receive a tiered royalty on net sales in the mid-to-upper single digits, as well as regulatory and financing milestones. Ligand will not incur any expenses to develop or commercialize PTX-022. "This transaction provides Palvella Therapeutics with capital to complete its planned clinical trials that could be the basis for registration and approval of a novel and important new medicine," said John Higgins, Chief Executive Officer of Ligand. "The PTX-022 program is being managed by a team of distinguished and capable scientists who have identified a novel way to treat PC. This deal has the potential to provide lucrative economics to Ligand for a drug that could launch in 2022, should its development be successful and if it is approved by the FDA. Ligand is assembling a large collection of significant royalty-bearing assets and partnerships for drugs, many of which could launch over the next several years. Ligand expects to continue entering into license agreements from its existing technologies and will continue to explore ways to acquire new revenue streams through product investments, such as this deal with Palvella, or through company acquisitions."
UBS

Hot Stocks

15:38 EDT Fin Cen announces $14.5M assessment against UBS for vioations against BSA - The Financial Crimes Enforcement Network, FinCEN, announced an assessment against UBS Financial Services for willful violations of the Bank Secrecy Act, BSA. FinCEN assessed a $14.5M civil money penalty, of which $5M will be paid to the U.S. Department of the Treasury and the remainder will be concurrent with penalties for similar or related conduct imposed by the Securities and Exchange Commission and the Financial Industry Regulatory Authority. As described in the assessment, UBSFS failed to develop and implement an appropriate, risk-based anti-money laundering program that adequately addressed the risks associated with accounts that included both traditional brokerage and banking-like services. UBSFS failed to implement appropriate policies and procedures to ensure the detection and reporting of suspicious activity through all accounts-particularly for those accounts that exhibited little to no securities trading. The firm did not adequately structure its AML program to address the use of securities accounts for the purpose of moving funds rather than trading securities. Reference Link
RHHBY

Hot Stocks

15:12 EDT Roche treatment of follicular lymphoma granted FDA orphan status - Genentech, a Roche company, received FDA orphan designation for its treatment of follicular lymphoma, according to a post to the agency's website. Reference Link
MSG

Hot Stocks

15:09 EDT Madison Square Garden CEO says 'no plans to sell Knicks' - In response to speculation about the New York Knicks sparked by a press story, The Madison Square Garden Company issued the following statement from James Dolan, the company's executive chairman and CEO. "As we have previously stated, there are no plans to sell the Knicks."
AVRO

Hot Stocks

15:09 EDT Avrobio treatment of Fabry Disease granted FDA orphan designation - The FDA granted orphan designation to Avrobio's treatment of Fabry Disease, according to a post to the agency's website. Reference Link
MBIO

Hot Stocks

15:07 EDT Mustang Bio blastic plasmacytoid dendritic cell neoplasm drug gets orphan status - The FDA granted orphan designation to Mustang Bio's treatment of blastic plasmacytoid dendritic cell neoplasm, according to a post to the agency's website. Reference Link
NEWT

Hot Stocks

15:05 EDT Newtek Business Services approves repurchase of up to 300K shares - Newtek Business Services announced that its board of directors approved a repurchase program under which the company may repurchase up to 300,000 shares of its common stock, which represents approximately 1.6% of the outstanding common shares of the company, as of September 30.
BMY

Hot Stocks

15:03 EDT Bristol-Myers treatment of idiopathic pulmonary fibrosis granted orphan status - The FDA granted orphan designation to Bristol-Myers' treatment of idiopathic pulmonary fibrosis, according to a post to the agency's website. Reference Link
TGNA

Hot Stocks

15:02 EDT Tegna says John Janedis is joining the company as SVP capital markets, IR - Tegna president and CEO Dave Lougee announced that John Janedis is joining the company as senior vice president, capital markets and investor relations. Janedis, who was previously managing director and senior equity research analyst for media, cable and telecom at Jefferies LLC, will be responsible for leading TEGNA's treasury and investor relations functions. This newly created role will report to executive vice president and chief financial officer Victoria Harker. In this role, Janedis will be responsible for managing all treasury and banking activities and communicating TEGNA's growth strategy, financial performance and plans for building long-term shareholder value to investors, analysts and other external audiences. Jeffrey Heinz, vice president of investor relations, will report to Janedis. "John's extensive experience in the media sector and investor community are unique assets as we continue to distinguish ourselves as a pure play broadcaster and best-in-class operator," said Lougee. "John has been a leading research analyst in the sector for many years and I look forward to him bringing his valuable industry insights, finance experience and proven track record to TEGNA."
GSAT

Hot Stocks

14:36 EDT Globalstar jumps over 23% after litigation setttlement and 3GPP approval - Shares of mobile satellite voice and data services worldwide Globalstar (GSAT) are up over 23% in afternoon trading after announcing a settlement of litigation and news around 3GPP. SETTLEMENT OF LITIGATION: Globalstar, together with Mudrick Capital Management and Warlander Asset Management and all other litigation parties, announced that they have entered into a settlement agreement related to the litigation brought by Mudrick Capital and Warlander in Delaware Chancery Court involving Globalstar and certain of its directors, officers and employees. As a result of the agreement, the parties have agreed to the addition of three new seasoned telecom executives to the company's board -- Keith Cowan, Ben Wolff, and Mike Lovett. Additionally, Timothy Taylor, VP of Thermo and Globalstar's VP of Finance, Business Operations and Strategy will join the board to fill a vacancy left by a fourth board member retiring from his position on the board. 3GPP: Globalstar announced that the Third Generation Partnership Project has approved a global standard for terrestrial use of Globalstar's spectrum at 2483.5-2495 MHz. 3GPP has designated Globalstar's terrestrial S-band as Band 53, which now permits LTE services in the U.S. with additional geographies expected to be added in 2019. PRICE ACTION: Shares of Globalstar are up 23.4% to 37c per share in afternoon trading.
TSCO

Hot Stocks

14:31 EDT Tractor Supply announces goal of reducing facilities carbon emissions 25% - Tractor Supply Company announced a new goal to reduce carbon emissions from its facilities by 25% by 2025 from its 2015 baseline as a part of the company's Stewardship Program.
ASH

Hot Stocks

14:30 EDT Cruiser Caiptal criticizes Ashland for rejecting its board nominees - Cruiser Capital Advisors, which nominated four chemical executives to the board of Ashland Global Holdings (ASH), issued the following statement responding to Ashland's recent actions regarding the composition of the company's board: "Ashland's Governance and Nominating Committee has supposedly completed a thorough process for reviewing and evaluating Cruiser's director nominees. Yet in its recently filed proxy materials, the Board decided not to recommend any of these highly-qualified Nominees - Dr. Bill Joyce, Allen Spizzo, Carol Eicher, and Pat Gottschalk - for election to the Board. This decision was made without a single member of the Committee speaking to any of these Nominees and without anyone from the Company or its representatives even asking them how they would seek to improve Ashland. In our view, their review process was anything but thorough, and this lack of engagement is not in the best interest of stockholders. Furthermore, while Ashland's recently-announced plan to add a new independent director may sound like a positive development, we believe it is a disingenuous scheme to fundamentally retain the status quo on the Board. To be clear, under Ashland's announced plan, the Board will be able to appoint a new 11th member after the 2019 Annual Meeting of Stockholders, thereby depriving stockholders in the contested 2019 election of the opportunity to vote for their own Board of Directors."
C

Hot Stocks

14:19 EDT Citi reports November credit loss 2.70% vs. 2.63% last month - Reports 30-plus day delinquencies 1.60% vs. 1.58% last month.
GD

Hot Stocks

14:02 EDT General Dynamics awarded $5B Navy SeaPort NxG contract - General Dynamics Information Technology announced it will support the U.S. Navy through a new contract vehicle known as SeaPort NxG. The multiple-award, indefinite delivery, indefinite quantity contract holds a total value of $5B. It includes a five-year base period with one five-year option.
EEP...

Hot Stocks

13:35 EDT Enbridge Energy,Enbridge Energy Management announce approval of proposed mergers - Enbridge Energy Partners (EEP) and Enbridge Energy Management (EEQ) announced that EEP unitholders and EEQ shareholders, at special meetings held earlier, respectively approved the previously announced separate merger agreements with respect to the merger of EEP with a wholly owned subsidiary of Enbridge (ENB), and the merger of EEQ with a wholly owned subsidiary of Enbridge, respectively. Subject to customary closing conditions in the respective merger agreements, both the EEP Merger and the EEQ Merger are expected to close on December 20, 2018. Pursuant to the Agreement and Plan of Merger, dated as of September 17, 2018, for the EEP Merger, Enbridge will acquire all of the outstanding public Class A common units of EEP, resulting in EEP becoming an indirect, wholly owned subsidiary of Enbridge. At the closing, each public Class A unit common of EEP will be exchanged for 0.335 common shares of Enbridge. Pursuant to the Agreement and Plan of Merger, dated as of September 17, 2018, for the EEQ Merger, Enbridge will acquire all outstanding public Listed Shares of EEQ, resulting in EEQ becoming a direct, wholly owned subsidiary of Enbridge. At the closing, each public Listed Share of EEQ will be exchanged for 0.335 common shares of Enbridge.
TWTR

Hot Stocks

13:32 EDT Twitter drops 5% to $34.09 after disclosing issue related to support forms
TWTR

Hot Stocks

13:31 EDT Twitter: Investigating origins since becoming aware of issue
TWTR

Hot Stocks

13:30 EDT Twitter: Issue did not expose full phone numbers, other personal data
TWTR

Hot Stocks

13:30 EDT Twitter says issue was fixed by November 16
TWTR

Hot Stocks

13:30 EDT Twitter discloses issue related to support forms - Twitter says that "We have become aware of an issue related to one of our support forms, which is used by account holders to contact Twitter about issues with their account. We began working to resolve the issue on November 15 and it was fixed by November 16. This could be used to discover the country code of people's phone numbers if they had one associated with their Twitter account, as well as whether or not their account had been locked by Twitter. We lock an account if it appears to be compromised or in violation of the Twitter Rules or our Terms of Service. More on what it means when an account is in a locked state here. Importantly, this issue did not expose full phone numbers or any other personal data. We have directly informed the people we identified as being affected. We are providing this broader notice as it is possible that other account holders we cannot identify were potentially impacted. Since we became aware of the issue, we have been investigating the origins and background in order to provide you with as much information as possible. During our investigation, we noticed some unusual activity involving the affected customer support form API. Specifically, we observed a large number of inquiries coming from individual IP addresses located in China and Saudi Arabia. While we cannot confirm intent or attribution for certain, it is possible that some of these IP addresses may have ties to state-sponsored actors. We continue to err on the side of full transparency in this area and have updated law enforcement on our findings. No action is required by account holders and we have resolved the issue." Reference Link
BK

Hot Stocks

13:09 EDT SEC says BNY Mellon to pay over $54M for improper handling of ADRs - The Securities and Exchange Commission today announced that Bank of New York Mellon will pay more than $54M to settle charges of improper handling of "pre-released" American Depositary Receipts. ADRs - U.S. securities that represent foreign shares of a foreign company - require a corresponding number of foreign shares to be held in custody at a depositary bank. The practice of "pre-release" allows ADRs to be issued without the deposit of foreign shares provided brokers receiving them have an agreement with a depositary bank and the broker or its customer owns the number of foreign shares that corresponds to the number of shares the ADR represents. The SEC's order found that BNY Mellon improperly provided ADRs to brokers in thousands of pre-release transactions when neither the broker nor its customers had the foreign shares needed to support those new ADRs. Such practices resulted in inflating the total number of a foreign issuer's tradeable securities, which resulted in abusive practices like inappropriate short selling and dividend arbitrage that should not have been occurring. This is the seventh action against a bank or broker and third action against a depositary bank resulting from the SEC's ongoing investigation into abusive ADR pre-release practices. Information about ADRs is available in an SEC Investor Bulletin. Without admitting or denying the SEC's findings, BNY Mellon agreed to disgorge more than $29.3M in alleged ill-gotten gains plus pay $4.2M in prejudgment interest and a $20.5M penalty for total monetary relief of more than $54M. The SEC's order acknowledges BNY Mellon's cooperation in the investigation and remedial acts.
FB

Hot Stocks

13:00 EDT Gundlach says Facebook has 'symstemic problems,' short call was right - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
AAPL

Hot Stocks

12:59 EDT Gundlach sees Apple selloff as 'emblematic of market topping' - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
AAPL

Hot Stocks

12:59 EDT Apple not giving iPhone numbers anymore 'can't be a good sign,' says Gundlach - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
SPX SPY

Hot Stocks

12:51 EDT Gundlach says short-term, high quality bond portfolio 'best way to go' into 2019 - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
SPX SPY

Hot Stocks

12:49 EDT Gundlach says 'capital preservation' is best idea for 2019 - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
SPX SPY

Hot Stocks

12:38 EDT Gundlach says China, U.S. trade war getting worse - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
SPX SPY

Hot Stocks

12:34 EDT Gundlach reiterates view that next big move for U.S. dollar is down - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
SPX SPY

Hot Stocks

12:32 EDT Hearings, investigations into Trump 'building uncertainty,' says Gundlach - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
SPX SPY

Hot Stocks

12:14 EDT Gundlach says Federal Reserve should not raise rates this week - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
SPX SPY

Hot Stocks

12:11 EDT Gundlach sees 10-year treasury at 6% by 2021 - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
SPX SPY

Hot Stocks

12:09 EDT Almost no real economic growth happening away from deficit, Gundlach says - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
AXP

Hot Stocks

12:06 EDT American Express reports November net write-off rate 2.0% vs. 2.0% last month - Reports November 30 days past due loans 1.4% vs. 1.4% last month.
SPX SPY

Hot Stocks

12:06 EDT Gundlach thinks bear market 'lasts a long time' - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
VIX

Hot Stocks

12:05 EDT Gundlach says VIX 'disturbing' as its not going higher - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
SPX SPY

Hot Stocks

12:02 EDT Jeffrey Gundlach says 'pretty sure' stocks in bear market - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
SPX SPY

Hot Stocks

12:02 EDT Jeffrey Gundlach says 'pressure sure' stocks in bear market - Jeffrey Gundlach of DoubleLine Capital is speaking on CNBC.
FTCH

Hot Stocks

12:00 EDT Farfetch falls -10.6% - Farfetch is down -10.6%, or -$2.54 to $21.34.
UGAZ

Hot Stocks

12:00 EDT VelocityShares 3x Long Natural Gas ETN falls -11.8% - VelocityShares 3x Long Natural Gas ETN is down -11.8%, or -$10.84 to $81.02.
MOH

Hot Stocks

12:00 EDT Molina Healthcare falls -13.2% - Molina Healthcare is down -13.2%, or -$17.38 to $114.34.
AGI

Hot Stocks

12:00 EDT Alamos Gold rises 8.8% - Alamos Gold is up 8.8%, or 26c to $3.23.
DGAZ

Hot Stocks

12:00 EDT VelocityShares 3x Inv Natural Gas ETN rises 11.4% - VelocityShares 3x Inv Natural Gas ETN is up 11.4%, or $8.98 to $87.67.
CDE

Hot Stocks

12:00 EDT Coeur Mining rises 14.8% - Coeur Mining is up 14.8%, or 56c to $4.38.
PRQR

Hot Stocks

11:55 EDT ProQR Therapeutics announces publication of QR-110 data in Nature Medicine - ProQR Therapeutics announced the publication of a peer-reviewed manuscript describing the previously announced interim results of a clinical trial of QR-110 for the treatment of Leber's congenital amaurosis 10, or LCA10, in the journal Nature Medicine. "It was enormously gratifying to see robust improvements in visual acuity and significant augmentations in the patient's ability to detect lights, and impressive to observe these effects within the first three months following a single injection," said Professor Artur V. Cideciyan, Ph.D., who was one of the co-investigators at the Scheie Eye Institute of the University of Pennsylvania. "LCA10 is a severe form of childhood blindness and this is a major step forward in the treatment of these previously incurable conditions," said Professor Samuel G. Jacobson, M.D., Ph.D, who is the ophthalmologist caring for four of the patients enrolled in the study and is also a co-investigator at the Scheie Eye Institute. Published results detail a planned interim analysis of the ongoing PQ-110-001 first-in-human clinical study, evaluating QR-110 in patients with LCA10. The publication focused on a landmark analysis of eight subjects who reached three months of single dose treatment experience. Results demonstrate a substantive overall improvement in best corrected visual acuity with a mean improvement of -0.67 LogMAR in the treated eye versus 0.02 LogMAR in the contralateral eye. The majority of patients showed an increase of at least -0.3 LogMAR in the treated eye, which is generally considered clinically meaningful, and equivalent to 15 letters, or three lines of improvement for individuals able to read a standard eye chart. Visual acuity improvements were also associated with concordant improvements in full-field stimulus thresholds to both blue and red light, improved mobility course navigation and ocular instability measurement.
OUT

Hot Stocks

11:33 EDT Outfront Media announces Lowell Simpson hired as Chief Information Officer - Outfront Media announced the hiring of Lowell Simpson as Executive Vice President, Chief Information Officer. Lowell joins Outfront from MediaCom Worldwide where he held the position of Global Chief Information Officer. Prior to that role, Lowell spent time at Discovery Communications and PriceWaterhouseCoopers in various project management and technology positions, the company stated.
FB TWTR

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11:10 EDT Walt Mossberg says he's quitting Facebook, Instagram, Messenger - Walt Mossberg, the co-founder of AllThingsD and Recode, the former executive editor at The Verge and a former columnist at the Wall Street Journal, tweeted that "I've decided to quit Facebook (FB) around the end of the year. I am doing this - after being on Facebook for nearly 12 years - because my own values and the policies and actions of Facebook have diverged to the point where I'm no longer comfortable there. I am also quitting Facebook-owned Instagram and Messenger. I will remain on Twitter (TWTR), and will continue to communicate via iMessage, email and SMS text." He added that "I am hardly the first person to quit Facebook and I am not urging anyone else to do so, or trying to spark some dump-Facebook movement. Nor am I judging anyone who remains, or everyone who works there. This is just a personal decision about where online I wish to participate." Reference Link
KEYS

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11:04 EDT Keysight Technologies, MediaTek collaborate for 5G multimode devices - Keysight Technologies announced that the company's 5G virtual drive testing Toolset is helping MediaTek to accelerate end-to-end data throughput performance validation of multimode 5G New RadioDevices. Keysight's VDT Toolset enables 5G chipset and device manufacturers to bridge the gap between lab and field testing. Based on Keysight's PROPSIM F64 5G channel emulator, which emulates real-world radio frequency network conditions, the VDT Toolset uses data captured in the field to build tests. These are then replayed in the field in a controlled laboratory environment as often as needed. This enables MediaTek to validate the performance of new 5G products under typical mobile user conditions such as video streaming, web browsing, and voice calls without running consuming field tests. MediaTek currently uses Keysight's VDT Toolset to validate 4G devices for operation in high speed train scenarios.
MYL SHPG

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10:49 EDT Mylan announces U.S. launch of generic Lialda delayed-release tablets - Mylan N.V. (MYL) announced the U.S. launch of Mesalamine Delayed-Release Tablets USP, 1.2 g, a generic version of Shire's (SHPG) Lialda Delayed-Release Tablets. Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product, which is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of UC. U.S. sales for Mesalamine Delayed-Release Tablets USP, 1.2 g, were approximately $842M for the 12 months ending October 31, 2018, according to IQVIA.
MYL AGN

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10:33 EDT Mylan announces U.S. launch of generic Canasa suppository - Mylan N.V. (MYL) announced the U.S. launch of Mesalamine Rectal Suppository, 1000 mg, the first generic version of Allergan's (AGN) Canasa Rectal Suppository, 1000 mg. Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product, which is for the treatment of mildly to moderately active ulcerative proctitis. According to the FDA approval letter, Mylan was the first applicant to submit a substantially complete ANDA for Mesalamine Rectal Suppository, 1000 mg, containing a Paragraph IV certification, and is eligible for 180 days of generic drug exclusivity. U.S. sales for Mesalamine Rectal Suppository, 1000 mg, were approximately $263M for the 12 months ending October 31, 2018, according to IQVIA.
APD

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10:33 EDT Air Products announces NA price increase for liquid and bulk industrial gases - Effective January 1, 2019, or as contracts permit, Air Products announces it will increase product pricing, monthly service charges, and surcharges for merchant customers in North America. The pricing adjustments include increases of: Up to 20% for liquid argon; Up to 10% for liquid nitrogen, liquid oxygen, liquid carbon dioxide and monthly service charges. "Some price adjustments may be outside of these ranges based on specific situations. Helium prices will also be increased based on supply/demand and cost situations and may be customer specific. These adjustments are in response to increases in sourcing, production and delivery costs, and support continued investments in reliability, security, and safety," the company stated.
NIO

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10:25 EDT NIO announces launch of ES6 electric SUV - NIO Inc. announced that it launched the NIO ES6 on December 15 during the annual NIO Day celebration. "This high-performance long-range intelligent electric SUV starts at a pre-subsidy price of 358,000 RMB, and is available now for public pre-order via the NIO app, with delivery to start in June 2019," the company reported.
CBPO

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10:09 EDT David Gao 'disappointed' over dismissal of lawsuit against China Biologic - David Gao, a shareholder of China Biologic Products Holdings, issued the following statement on the Grand Court of the Cayman Islands' recent decision regarding his lawsuit against the company: "I am disappointed that my lawsuit was dismissed and will evaluate all options as I continue my efforts to protect my and other minority shareholders' interests in the company. It is unfortunate that the legal process is hindered because of a Cayman law technicality with regard to my standing to file such a lawsuit before the court can hear the substance of the case regarding the improper purpose of the Board's actions. The Board's hastily arranged private placement to a small group of handpicked investors, including Centurium Capital, Chairman David Li's private equity fund, improperly transferred voting power away from the minority shareholders. With the assigned voting rights from the new investors, the Board can block any decision or action it does not support, which should be alarming given their poor track record. The Board has taken a number of questionable actions, including failing to engage on an US$118.00 all-cash proposal to acquire the Company and instead moving forward with a value destructive private placement that resulted in China Biologic's stock falling to the lowest at $60.08. I believe the minority shareholders have lost confidence in the Board's ability to act on behalf of their interests. While it is quite clear that all shareholders would have been best served if the Board had accepted the $118 offer just months ago, I am particularly concerned that David Li may be capable of using his concentrated voting power to take China Biologic private at a price lower than what the Board claimed did not reflect the intrinsic value of the company. The best interests of the Company, its customers and its shareholders are at stake and I appreciate the continued support of my fellow shareholders as I take all the necessary steps to ensure China Biologic's Board acts in a responsible manner."
DOVA

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10:08 EDT Dova Pharmaceuticals trading resumes
CAR IDSY

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10:07 EDT Avis Budget to connect additional 75,000 cars though I.D. Systems devices - Avis Budget Group (CAR) will connect an additional 75,000 vehicles to its cloud-based, next generation platform through the installation of in-vehicle telematics devices provided by I.D. Systems (IDSY). The new agreement builds on the successful deployment of 50,000 units during the past year. I.D. Systems' wireless in-vehicle management system permits two-way data communications between a vehicle and Avis Budget Group's cloud-based system and its mobile apps, effectively "connecting" the car. The new units will support both the Avis and Zipcar mobile apps, meaning Avis Budget Group can more easily position vehicles across the brands to meet periods of high demand or for other business reasons. They also enable utilization in Europe, and Avis Budget Group will begin testing them in select markets in 2019.
LNC

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10:04 EDT Lincoln Financial Group announces eMoney, Redtail integrations - Lincoln Financial Group announced new partnerships that will offer fee-only advisors improved planning and data management capabilities and make it easier to use Lincoln's suite of annuity solutions. By integrating capabilities from eMoney Advisorand Redtail Technology, Lincoln will continue to expand and evolve its technology platform available to fee-only advisors. Advisors using the eMoney platform will receive a more comprehensive snapshot of their Lincoln annuity accounts, enabling them to more fluidly include commission-free insurance solutions in their client portfolios. eMoney's industry-leading client portal offers advisors a real-time, on-demand financial experience that helps strengthen relationships and keep them at the forefront of digital trends. Fee-only advisors will experience seamless features with the portal, including self-registration and onboarding, mobile web access, account aggregation and organization, and unlimited, secure document storage. Lincoln's integration with Redtail helps advisors simplify the management of their businesses, substantially cutting down on the time needed for manual processes and improving their overall workflow. These new integrations are the latest enhancements Lincoln has made in a series of decisions to help build its presence among registered investment advisors.
DOVA

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10:03 EDT Dova Pharmaceuticals trading halted, volatility trading pause
UGAZ

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10:00 EDT VelocityShares 3x Long Natural Gas ETN falls -8.3% - VelocityShares 3x Long Natural Gas ETN is down -8.3%, or -$7.66 to $84.20.
CNC

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10:00 EDT Centene falls -8.4% - Centene is down -8.4%, or -$10.76 to $116.77.
MOH

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10:00 EDT Molina Healthcare falls -14.7% - Molina Healthcare is down -14.7%, or -$19.37 to $112.35.
DGAZ

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10:00 EDT VelocityShares 3x Inv Natural Gas ETN rises 8.1% - VelocityShares 3x Inv Natural Gas ETN is up 8.1%, or $6.39 to $85.08.
CDE

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10:00 EDT Coeur Mining rises 8.7% - Coeur Mining is up 8.7%, or 33c to $4.15.
AGI

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10:00 EDT Alamos Gold rises 9.1% - Alamos Gold is up 9.1%, or 27c to $3.24.
DFFN

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09:59 EDT Diffusion Pharmaceuticals awarded patent for use of TSC in conjuction with tPA - Diffusion Pharmaceuticals announced that it has been awarded a patent for the use of its breakthrough drug, trans sodium crocetinate, in conjunction with Tissue Plasminogen Activator for the treatment of stroke. Currently, tPA - a thrombolytic used to break down blood clots in patients suffering from ischemic stroke - is the only FDA-approved therapeutic stroke treatment. Worldwide, stroke is the second leading cause of death and is responsible for an estimated 6.2M deaths per year. The granting of Diffusion's patent follows the recent news that the company received FDA approval to enroll patients in an ambulance-based Phase 2 clinical trial testing TSC for the treatment of both ischemic and hemorrhagic stroke. The use of TSC represents a potential breakthrough in the treatment of stroke, which afflicts nearly 800,000 Americans each year. Diffusion's FDA-approved Phase 2 clinical trial will focus on the concept of early intervention - allowing patients suffering from either ischemic or hemorrhagic stroke to receive TSC on the ambulance or in the emergency department immediately upon onset of symptoms. Patients can then, separately, receive tPA in-hospital if they are found to be suffering from ischemic stroke. If the clinical trial is successful, there is the potential to establish a new standard of care, with a combination drug therapy which could generate over $1B annually. With the notification by the United States Patent Office of the issuance of U.S. Patent 10,130,689, Diffusion now has patent protection over the use of TSC in conjunction with tPA in the United States, Japan, and Korea, with pending applications in Europe, Canada, China, Israel, and India. Seven-year Orphan exclusivity provides additional protection, and formulation patents provide protection for the TSC oral drug product until 2031, with possible extensions.
VUZI

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09:52 EDT Vuzix announces voluntary dismissal of class action lawsuit - Vuzix is pleased to announce the consolidated class action filed in the United States District Court Southern District of New York was voluntarily dismissed, without prejudice and without costs against all the defendants, by the plaintiff and their counsel on December 14, 2018. Vuzix had vigorously denied the class action allegations as meritless and is pleased that plaintiff and their counsel agreed to voluntarily dismiss the case.
CDE

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09:47 EDT Coeur Mining rises 4.5% - Coeur Mining is up 4.5%, or 17c to $3.99.
GOL

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09:47 EDT Gol Linhas rises 4.9% - Gol Linhas is up 4.9%, or 57c to $12.30.
DGAZ

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09:47 EDT VelocityShares 3x Inv Natural Gas ETN rises 8.0% - VelocityShares 3x Inv Natural Gas ETN is up 8.0%, or $6.33 to $85.02.
ALTM

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09:35 EDT Altus Midstream Company (Class A Stock) trading resumes
ALTM

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09:30 EDT Altus Midstream Company (Class A Stock) trading halted, volatility trading pause
PTSX

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09:25 EDT Court approves Point 360 second amended disclosure statement - Point.360 announced that United States Bankruptcy Court approved the company's second amended disclosure statement and scheduling plan confirmation status hearing and related deadlines.
BAC

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09:24 EDT Bank of America reports November card write-offs 2.68% vs. 2.43% last month - Reports November 30-plus day delinquencies 1.69% vs. 1.66% last month.
IBTX GBNK

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09:24 EDT Independent Bank receives regulatory approval for Guaranty Bancorp merger - Independent Bank (IBTX) announced that it has received all regulatory approvals necessary to complete its merger with Guaranty Bancorp (GBNK) by January 1, 2019.
MDT

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09:22 EDT Medtronic announces FDA approval of InterStim programmer - Medtronic announced FDA approval of the InterStim smart programmer for use with the InterStim system, which provides sacral neuromodulation therapy for the treatment of overactive bladder, or OAB, chronic fecal incontinence, or FI, and non-obstructive urinary retention. The new smart programmer streamlines multiple devices into a single, intuitive, touch screen mobile device and enables clinicians to personalize each patient's care and allows patients to manage their therapy. OAB and FI are treatable and common conditions.
GNUS

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09:19 EDT Genius Brands licenses rights to Gershwin Entertainment for Rainbow Rangers live - Genius Brands new animated adventure preschool series, Rainbow Rangers, will be heading to the live stage following a rights acquisition deal for live touring shows by diversified entertainment production and marketing agency Gershwin Entertainment. The live theater production debut of Rainbow Rangers is timed to coincide with the preschool brand's U.S. retail launch in 2019. The announcement was made jointly by Genius Brands' and Gershwin.
CUTR

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09:16 EDT Cutera announces FDA approval of new indication for enlighten laser platform - Cutera announced the FDA approved clearance of an additional indication, for acne scars, on its enlighten laser platform. The enlighten is also cleared by the FDA for tattoo removal and the treatment of benign pigmented lesions.
HON

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09:16 EDT Honeywell announces new e-commerce platform 'GoDirect Trade' - Honeywell is bringing the ease of everyday online buying and selling to the aviation parts industry with GoDirect Trade. The new e-commerce platform will improve access to new and used aircraft parts for airlines, air transport and business aviation customers by offering transparent pricing and the option to buy inventory directly from its website - a first-of-its-kind experience.
GS...

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09:16 EDT Fly Intel: Pre-market Movers - HIGHER: Evofem (EVFM), up 18% after the AMPOWER Phase 3 trial met its primary endpoint... Axovant Sciences (AXON), up 14% after Jefferies analyst Michael Yee upgraded the stock to Buy and raised his price target for the shares to $3.00. Data readouts over the next year could drive a "meaningful percentage" return for small cap investors and take Axovant shares to $3 from $1 in 2019, Yee tells investors... Barnes & Noble (BKS), up 5% after Craig-Hallum analyst Alex Fuhrman upgraded the stock to Buy and raised his price target to $10 from $7. In a research note to investors, the analyst says initial Q4 checks have indicated improved results, continued cost controls and better holiday sales results, which, combined with the ongoing sales process, should provide "intriguing" upside potential... Jack in the Box (JACK), up 5% after announcing it is exploring strategic, financing alternatives. LOWER: Weatherford (WFT), down 2% after $50M sale of surface data logging business... Best Buy (BBY), down 6% after BofA Merrill Lynch analyst Curtis Nagle downgraded the stock to Underperform from Neutral, citing his caution about key product categories that include TVs, Apple (AAPL) products and gaming... Tenet (THC), down 7% after being downgraded to Neutral from Outperform at Baird... Centene (CNC), down 7% after Goldman Sachs removed the stock from the Conviction Buy List and lowered its price target to $144 from $155 to reflect risk associated with a potential adverse outcome in the Texas versus United States ACA ruling... Goldman Sachs (GS), down 2% after the Wall Street Journal reports Malaysian authorities have filed criminal charges against the bank.
PSTI

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09:15 EDT Pluristem provides recap of KOL meeting on PAD - Pluristem provided a recap of the key opinion leader, or KOL, meeting on peripheral artery disease, or PAD, that the company hosted. The meeting focused on the current treatment landscape, unmet medical need, economic impact and potential market opportunities for treating patients with PAD, a serious but common circulatory problem characterize by a blockage of the arteries and reduced blood flow to the limbs. Risk factors include smoking, diabetes, heavy weight, cardiovascular problems & hypertension. In addition to a management update on the company's ongoing late-stage development of PLX-PAD, the meeting featured presentations. PAD represents a significant unmet medical need. Major amputation and death are the ultimate consequences of critical limb ischemia; a one-year amputation and mortality rates range from 30-40%. PAD carries a five-year mortality rate higher than most cancers. The 5-year mortality rate from PAD is higher than most of cancers. Many CLI patients do not benefit from, or are not candidates for, current revascularization techniques. 85% of CLI patients undergo surgical or endovascular procedures to restore blood flow, however, 20% of these do not benefit. The remaining 15% are not candidates for revascularization. Allogenic placental cell therapies such as PLX-PAD appear to be more potent and efficient then autologous cell and gene therapies. It is estimated that 19.8 million people suffer from PAD in the U.S. alone. This is expected to increase to 24.5 by 2030.
MAXR

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09:14 EDT Maxar's MDA, Orbital Insight expand SAR satellite imagery agreement - MDA, a Maxar Technologies company, and Orbital Insight announced the latest agreement providing new datasets for Orbital Insight's product offerings. MDA will provide high-resolution imagery from its RADARSAT-2 synthetic aperture radar satellite to Orbital Insight, which will process and transform the data into actionable intelligence for the energy industry.
RMD

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09:13 EDT ResMed subsidiary Brightree acquires Apacheta, terms not disclsoed - Brightree announced it has acquired privately held mobile delivery and cloud-based software-as-a-service provider Apacheta Corporation, further expanding the SaaS portfolio of Brightree's owner, ResMed. The terms of the transaction were not disclosed.
WWE SKYAY

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09:13 EDT WWE, Sky extend partnership in New Zealand - WWE (WWE) and SKY (SKYAY) will extend their partnership into its 19th year with a new agreement to continue broadcasting WWE programming live in New Zealand, including WWE's flagship shows Raw and SmackDown as well as all of WWE's live monthly special events, including WrestleMania, SummerSlam, Survivor Series and Royal Rumble. SKY 5 will continue airing Raw live at 2 p.m. on Tuesdays with re-airs at 1:30 p.m. on Sundays, SmackDown live at 2 p.m. on Wednesdays with re-airs at 4:15 p.m. on Sundays, and Main Event, a one-hour in-ring show featuring Raw Superstars at 6 p.m. on Sundays. These shows will also be available for catch-up viewing on SKY On Demand. Additionally, Prime, SKY's free-to-air channel, will televise one-hour versions of Raw and SmackDown on Fridays beginning in 2019. Fans can order all of WWE's live monthly special events on SKY pay-per-view channel, SKY Arena.
OSTK

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09:11 EDT Overstock.com, tZERO to develop commodity contract token for GSR Capital - Overstock.com announced that Hong Kong-based private equity firm GSR Capital has retained tZERO to develop a smart contract token that will be utilized for an upcoming sale of cobalt. Subject to compliance with applicable regulatory requirements, the sale is expected to offer recurring tranches of electric vehicle, or EV, battery-grade cobalt, with up to $200M of the material projected to be available for sale in 2019, with more planned for 2020. tZERO and GSR Capital intend to build an ecosystem in Asia for tokenized commodity purchase contracts that would simplify the process of identifying, purchasing and tracking the supply of rare minerals. The companies also envision adding a security token trading platform in the region, subject to compliance with applicable regulatory requirements. To accommodate an additional key partner in that project, the companies will be extending the deadline to finalize their previously-announced equity investment until February 28, 2019.
CMTL

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09:10 EDT Comtech receives $3.6M renewal agreement - Comtech Telecommunications announced that during its second quarter of fiscal 2019, its Enterprise Technologies group, which is part of Comtech's Commercial Solutions segment, has received a two-year renewal agreement worth $3.6M for use of its Location-Based Services platform for a Fortune 500 company doing business in the telecom industry.
AGS

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09:09 EDT PlayAGS to acquire Integrity Gaming for $49M in cash - PlayAGS announced it has entered into a definitive agreement to acquire all issued and outstanding common shares of Integrity Gaming Corp. for a cash payment of C$0.46 per share or a total transaction value of $49M, which includes repaying $36M of Integrity's outstanding debt. The transaction is expected to be funded with cash on the balance sheet and to close in the first half of 2019, subject to approval by Integrity's shareholders, receipt of applicable regulatory, court, and third-party approvals, and other customary closing conditions. In fiscal 2017, Integrity generated revenue of approximately $16M and pre-synergy EBITDA of approximately $9M. As a result of revenue optimization and other efficiencies, the company expects that adjusted EBITDA will grow at approximately 15% on an annualized and non-GAAP basis, beginning in fiscal 2019.
IEP

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09:09 EDT Icahn Automotive to acquire RPM Automotive, terms not disclosed - Icahn Automotive Group announced that it has entered into a definitive agreement to acquire RPM Automotive. Headquartered in Jacksonville, Fla., RPM Automotive operates 10 locations with more than 100 service bays throughout the Northeastern part of the state. The deal is subject to customary closing conditions but is expected to close by year-end.
FNJN JNPR

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09:09 EDT Jury finds non-infringement of Claim 10 of Finjan's '494 patent by Juniper - Finjan Holdings (FNJN) announced that its subsidiary Finjan, Inc.'s first in a series of trials for infringement of several of its U.S. patents against Juniper (JNPR) resulted in a jury verdict of non-infringement. Specifically, a jury found that Juniper's SRX gateway network appliances with SkyATP cloud-based scanning systems did not infringe claim 10 of Finjan's U.S. Patent No. 8,677,494. No decision has been made on additional asserted claims of the '494 Patent.
AGS

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09:07 EDT PlayAGS to acquire Integrity Gaming for $49M
BAESY

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09:06 EDT BAE Systems receives $96.6M U.S. Army contract modification - BAE Systems has received a U.S. Army contract modification valued at $96.6M, bringing the total contract value to $158M, to design, build, and commission a natural gas-fired steam facility at Holston Army Ammunition Plant, an Army-owned, contractor-operated site located in Kingsport, Tennessee. The modernization project will replace an existing coal-fired power supply and greatly reduce the facility's environmental footprint when the new natural gas plant is commissioned. The construction of the natural gas facility is part of a long-term, U.S. Army-driven modernization requirement for the HSAAP installation, in part meant for more efficient energy production. The estimated completion date is late 2021.
RPM

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09:06 EDT RPM acquires Siamons International, terms not disclosed - RPM International announced that its Rust-Oleum group has acquired Siamons International, provider of the Concrobium brand of non-toxic specialty mold cleaners. Based in Ontario, Canada, Siamons has annual net sales of approximately $20M. Terms of the transaction, which is expected to be accretive to earnings within one year, were not disclosed.
NTRP

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09:05 EDT Neurotrope announces publication of data from Phase 2 study of Bryostatin-1 - Neurotrope announced that data from its Phase 2, multidose, exploratory trial evaluating Bryostatin-1 as a treatment of cognitive deficits in moderate to severe Alzheimer's disease were published online in the Journal of Alzheimer's Disease. The double-blind, placebo-controlled, Phase 2 trial, which was completed in May 2017, randomized patients 1:1:1 into 20 mug Bryostatin-1, 40 mug Bryostatin-1, and placebo arms. This peer-reviewed article provides what we believe is the first comprehensive data presentation of the Phase 2 trial of a drug with a new mechanistic approach for advanced AD. The study was designed to assess the safety and efficacy of Bryostatin-1 as a treatment of cognitive deficits in patients with moderate to severe AD. Patients enrolled in the study were allowed to continue on background therapy, including cholinergic and/or anti-glutamatergic treatment. These therapies are known to yield symptomatic efficacy, but their effect has not been shown to treat underlying disease progression. The primary efficacy analysis for this Bryostatin-1 trial was change in Severe Impairment Battery scores. For patients in the 20 microg Bryostatin-1 dose group, SIB scores were greater than baseline, indicating persistence of improvement in cognitive function. A pre-specied ANCOVA for baseline memantine interaction with Bryostatin-1 and positive post-hoc trend analyses were statistically signicant. The magnitude of improvement was greater in a pre-specified exploratory analysis of patients not on memantine therapy. Analyses of patients in this group showed evidence of sustained SIB improvement over baseline compared to placebo patients not on memantine. Individual patient SIB scores over time revealed that 15 out of 16 patients in the 20 mug Bryostatin-1, non-memantine group showed improvement in SIB at 2 - 4 weeks post-dosing. For placebo patients and for patients on baseline memantine, there were no consistent increases in SIB measures over time. In addition, the safety profile was similar for patients treated with 20 mug Bryostatin-1 and placebo. Neurotrope is currently evaluating Bryostatin-1 in 100 moderate to severe AD patients not on memantine in a confirmatory, placebo-controlled, Phase 2 trial, initiated in July 2018. Enrollment is proceeding as planned, and data from this study are expected during the third quarter of 2019.
MDT SSNLF

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09:03 EDT Medtronic announces FDA approval of InterStim smart programmer - Medtronic (MDT) announced U.S. Food and Drug Administration approval of the InterStim smart programmer for use with the InterStim system, which provides sacral neuromodulation therapy for the treatment of overactive bladder, chronic fecal incontinence and non-obstructive urinary retention. The new smart programmer streamlines multiple devices into a single, intuitive, touch screen Samsung (SSNLF) mobile device and enables clinicians to personalize each patient's care and allows patients to manage their therapy simply and discreetly. OAB and FI are treatable, extremely common and embarrassing conditions. More than 37M adults in the United States - almost one in six - suffer from OAB and nearly 20M Americans - about one in 12 - have bowel incontinence.
AMGN

Hot Stocks

09:02 EDT Amgen submits BLA for ABP 710 to FDA - Amgen announced the submission of a Biologics License Application to the U.S.FDA for ABP 710, a biosimilar candidate to REMICADE.
CNDT

Hot Stocks

08:47 EDT Conduent unit selected to deploy next-gen fare collection system in Flanders - Conduent Transportation, a business unit of Conduent, has been selected by Flemish public transport operator De Lijn to install a next-generation fare collection system across the Flanders region of Belgium. Conduent will deploy its advanced, digitally powered ATLAS fare collection system, as well as operate the system on behalf of De Lijn, for a period of 10 years.
LION

Hot Stocks

08:45 EDT Fidelity Southern trading resumes
TDOC

Hot Stocks

08:44 EDT Teladoc CFO, COO Mark Hirschhorn to resign - Teladoc announced that Mark Hirschhorn has resigned as executive VP, COO and CFO for Teladoc, effective January 1, 2019. The company has initiated a formal search process to fill the roles of COO and CFO. While the search is underway, two leaders will take on these responsibilities during the transition. Teladoc president Peter McClennen will take on the role of interim COO and senior VP, CAO and controller Gabriel Cappucci will coordinate all finance activity, until permanent replacements are named. In addition, Cappucci will continue to have authority over accounting and financial statement preparation.
ACER

Hot Stocks

08:41 EDT Acer Therapeutics appoints Salma Jutt as CCO - Acer Therapeutic announced that it has appointed Salma Jutt as CCO. If Edsivo is approved by the FDA for the treatment of vascular Ehlers-Danlos syndrome, or vEDS, Jutt will lead its launch and commercialization. Jutt will report directly to Chris Schelling, CEO and founder of Acer. Jutt brings over 20 years of experience in life sciences managing U.S. and global P&Ls, building and leading integrated teams across all commercial functions for large-scale product launches at companies.
HJLI

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08:38 EDT Hancock Jaffe Laboratories receives INVIMA approval for VenoValve trial - Hancock Jaffe Laboratories announced that it has received regulatory approval from INVIMA, the Colombian equivalent of the FDA, for its first-in-human trial for the VenoValve. INVIMA is the final regulatory approval needed to begin the first-in-human study in Bogota, Colombia. Hancock Jaffe will now make arrangements to export the VenoValves into Columbia and begin screening and enrolling patients for the study. The company will next provide an update once initial patient enrollment is completed and dates are set for the first implantations. The first-in-human Colombian study will initially include 5 to 10 patients who suffer from severe chronic venous insufficiency, or CVI, a condition that occurs when the valves in the veins of deep venous system of the leg are injured or destroyed, causing blood to pool in the lower extremities. Severe CVI includes swelling, debilitating pain, and skin ulcerations that become ongoing, open wounds. The VenoValve is a potential treatment and cure for severe CVI, a condition that effects approximately 4.5M people in the U.S. and tens of millions of additional patients worldwide. There are currently no FDA approved treatments for deep venous CVI.
ENB SEP

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08:37 EDT Enbridge, Spectra Energy Partners complete merger - Enbridge (ENB) and Spectra Energy Partners (SEP) announced that they have completed the previously announced merger pursuant to an Agreement and Plan of Merger dated as of August 24, 2018. The Merger resulted in Enbridge acquiring all of the outstanding public common units of SEP and SEP becoming an indirect, wholly owned subsidiary of Enbridge. Also effective December 17, the SEP common units will be suspended from trading on, and delisted from, the New York Stock Exchange. Common shares of Enbridge will continue to trade on both the NYSE and the Toronto Stock Exchange under the symbol "ENB".
OSIS

Hot Stocks

08:37 EDT OSI Systems receives IDIQ contract valued up to $450M - OSI Systems announced that its Healthcare division, Spacelabs Healthcare, received a firm-fixed-price, indefinite-delivery/indefinite-quantity, or IDIQ, contract valued at up to $450M from the Defense Logistics Agency, a combat support agency in the United States Department of Defense, to provide patient monitoring solutions, related accessories and training. The IDIQ contract has a five-year base term with a Government option to extend the term for an additional five years. The IDIQ contract provides the Company an opportunity to potentially receive delivery orders up to the value of the IDIQ award but does not guarantee any orders over the term of the contract.
BSIG

Hot Stocks

08:36 EDT BrightSphere names executive chairman Guang Yang as CEO - BrightSphere Investment Group announced that it has appointed Guang Yang as its CEO, effective immediately. This appointment follows Yang's appointment as executive chairman of the Board of Directors on November 30, 2018. Yang will succeed Steve Belgrad as CEO. Yang's experience in asset management spans nearly two decades, including a long and distinguished tenure at Franklin Templeton as EVP of Franklin Templeton Global Equities and chairman of Franklin Templeton China. Yang was a member of the BrightSphere Board from May 2017 to September 2018; he rejoined the BrightSphere Board and was appointed Executive Chairman in November 2018.
CGIX

Hot Stocks

08:36 EDT Cancer Genetics terminates proposed merger with NovellusDx - Cancer Genetics announced that it has terminated the previously-announced merger agreement with NovellusDx, effective immediately. As a result of the termination of the merger agreement, the company will pursue alternative strategic and financial transactions with the goal of enhancing shareholder value.The company will again work with Raymond James & Associates, Inc. as a financial advisor in its evaluation of a broad range of financial and strategic alternatives, including additional capital raising transactions, the acquisition of another company or complementary assets or the potential sale or merger of the Company or another type of strategic partnership.
REZI

Hot Stocks

08:34 EDT Resideo leaders purchase more than $900,000 in company shares - Leadership of Resideo Technologies, including president and CEO Mike Nefkens, and CFO Joe Ragan, purchased 43,914 shares of company stock in November and December, representing a combined $935,528 of open market purchases.
PLYA

Hot Stocks

08:34 EDT Playa Hotels & Resorts announces $100M share repurchase program - Playa Hotels & Resorts announced that the company's board has authorized the repurchase of up to $100M of its outstanding ordinary shares as market conditions and the company's liquidity warrant.
FRGI

Hot Stocks

08:33 EDT Fiesta Restaurant appoints Louis DiPietro as General Counsel - Fiesta Restaurant Group, parent company of the Pollo Tropical and Taco Cabana fast casual restaurant brands, announced the appointment of Louis DiPietro as the company's Senior Vice President, General Counsel and Corporate Secretary, effective December 17, replacing Maria Mayer, who has left the company. Most recently, DiPietro served as Senior Vice President, General Counsel and Corporate Secretary of Panera Bread.
CYRX

Hot Stocks

08:33 EDT Cryoport announces $25M investment from Petrichor - Cryoport announced the closing of a $25M investment from Petrichor Healthcare Capital Management. Under the terms of the investment, Petrichor purchased $10M of Cryoport common shares at a price per share of $10.00. In addition, Petrichor has funded a $15M note, which is convertible into Cryoport common shares at a price per share of $13.11, based upon a 20.0% premium to the 15-day VWAP immediately prior to closing. The note has a five-year term and bears cash interest at a rate of the 3-month LIBOR plus 6.0% per annum.
HEI HEI.A

Hot Stocks

08:33 EDT Heico raises semi-annual cash dividend 17% to 7c per share - HEICO Corporation announced that its Board of Directors approved a 17% increase in the semi-annual cash dividend to 7c per share from 6c per share, payable on both classes of common stock. The dividend is payable on January 17, 2019 to shareholders of record as of January 3, 2019.
ISR

Hot Stocks

08:33 EDT IsoRay names Lori Woods CEO - IsoRay announced that Lori Woods has been named CEO. Woods returns to IsoRay bringing more than 30 years' experience in the medical device technology and healthcare services industries. Woods first joined IsoRay as VP in July 2006. Her prior positions with the company also include roles as acting COO starting in February and her subsequent appointment as COO from February 2009 through January 2010. Immediately prior to her appointment as interim CEO in June of this year, Woods was a consultant to the company. Woods' appointment as CEO is effective immediately.
VRTX

Hot Stocks

08:32 EDT Vertex CFO Thomas Graney resigned last week with immediate effect - Vertex Pharmaceuticals disclosed that on December 13, Thomas Graney notified the company that he is resigning as Chief Financial Officer effective immediately. Graney will continue as an employee and assist in the transition through February 2019. Ian Smith, Vertex's Chief Operating Officer and former CFO, assumed the additional role of interim CFO on December 13.
CNC

Hot Stocks

08:32 EDT Centene: 2019 peak enrollment to exceed 2018 by 150,000-200,000 members - Centene has updated its estimates for health insurance marketplace enrollment for 2019. Based on enrollment reporting through December 16, 2018, the company expects its 2019 peak enrollment to exceed 2018 peak enrollment by 150,000 to 200,000 members. At its investor day on Friday, December 14, 2018, the company previously estimated its peak enrollment would be 50,000 to 150,000 higher than 2018. Both projections exclude approximately 80,000 Fidelis marketplace members. While the enrollment period for the Federal Exchange has concluded, the enrollment periods for several state-based exchanges continues beyond December 15, 2018. Final enrollment is determined after members make premium binder payments. The company will update its guidance for the final membership enrollment on its 2018 year end earnings call on Tuesday, February 5, 2019.
SPHS

Hot Stocks

08:30 EDT Sophiris Bio trading resumes
CGIX

Hot Stocks

08:30 EDT Cancer Genetics trading resumes
FOCS

Hot Stocks

08:29 EDT Focus Financial Partners announces Altman, Greenfield & Selvaggi to join Focus - Focus Financial Partners announced that Altman, Greenfield & Selvaggi has entered into a definitive agreement to join Focus. Focus also announced that Alpern Wealth Management and Griffon Financial Planning have entered into definitive agreements to join Focus partner Buckingham Strategic Wealth. Each of these transactions is expected to close on or about January 1, 2019, subject to customary closing conditions.
SEP

Hot Stocks

08:24 EDT Spectra Energy Partners trading halted, news dissemination
ABCB LION

Hot Stocks

08:19 EDT Ameris Bancorp, Fidelity Southern to merge in all-stock transaction - Ameris Bancorp (ABCB) and Fidelity Southern (LION) jointly announced the signing of a definitive merger agreement pursuant to which Fidelity will merge with and into Ameris in an all-stock transaction. Based on September 30, 2018 results, and excluding purchase accounting adjustments, the combined company will have approximately $16.2B in assets and a branching network across four states. Pro forma for the merger, 72 branches and $4.7B of deposits are located in the Atlanta MSA; 26 branches and approximately $1.8B of deposits are located in the Jacksonville MSA. Upon completion of the merger, James B. Miller, Jr., Chairman and Chief Executive Officer of Fidelity, will become Executive Chairman of Ameris and Ameris Bank and H. Palmer Proctor, Jr., President of Fidelity and Chief Executive Officer of Fidelity Bank, will become President of Ameris and Chief Executive Officer of Ameris Bank. Dennis J. Zember Jr. and Lawton E. Bassett, III will remain Chief Executive Officer of Ameris and President of Ameris Bank, respectively. Nicole S. Stokes will continue as Chief Financial Officer of both Ameris and Ameris Bank. Five Fidelity directors, including Messrs. Miller and Proctor, will join the Ameris board, which will be increased in size to 14 members upon completion of the merger. Under the terms of the definitive merger agreement, each share of Fidelity common stock, including restricted shares, will be converted into the right to receive 0.80 shares of Ameris common stock. Outstanding options to purchase shares of Fidelity common stock will be converted into options to purchase shares of Ameris common stock, with the exercise price and number of shares underlying each option adjusted to reflect the exchange ratio of 0.80. The transaction is valued at $27.22 per share, or approximately $750.7M in the aggregate, based on Ameris's closing stock price of $34.02 as of December 14, 2018. The merger agreement has been unanimously approved by the board of directors of each company. The transaction is expected to close in the second quarter of 2019 and is subject to customary closing conditions, including the receipt of regulatory approvals and the approval of the Ameris and Fidelity shareholders.
TEVA

Hot Stocks

08:19 EDT Teva announces FOCUS study met primary, secondary endpoints - Teva Pharmaceutical Industries announced positive topline results from the Phase IIIb FOCUS study that evaluated the efficacy and safety of fremanezumab for the preventive treatment of migraine in adult patients who previously experienced inadequate responses to two to four classes of preventive treatments. In the study of 838 patients, including those who suffer from either chronic or episodic migraine, patients treated with fremanezumab experienced highly significant reduction in the monthly average number of migraine days versus placebo over the 12 week assessment period, for both monthly and quarterly dosing regimens. In addition, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both quarterly and monthly dosing regimens. There were no safety signals detected in the study. Teva plans to submit the full results for medical meetings in 2019, as well as peer-reviewed publication. The Phase IIIb FOCUS study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study that evaluated the efficacy, safety, and tolerability of quarterly and monthly treatment with fremanezumab, compared to placebo. Adult patients with chronic migraine or episodic migraine who have responded inadequately to two to four classes of prior preventive treatments were enrolled in the study. Inadequate response is defined as: lack of efficacy after at least three months of therapy; or the patient cannot tolerate the drug; or the drug is contraindicated; or the drug is not suitable for the patient. The classes of medications include: beta-blockers, anticonvulsants, tricyclics, calcium channel blockers, angiotensin II receptor antagonists, onabotulinumtoxinA, and valproic acid. In the study, chronic migraine and episodic migraine patients were randomized in blinded-fashion 1:1:1 into one of three treatment groups - a quarterly dosing regimen, a monthly dosing regimen or matching placebo. An open-label extension of three months followed the placebo-controlled portion of the study.
ABCB LION

Hot Stocks

08:17 EDT Ameris Bancorp, Fidelity Southern to merge in all-stock transaction
FLT BAC

Hot Stocks

08:16 EDT FleetCor enters into $220M Accelerated Share Repurchase program - FLEETCOR (FLT) announced that it has entered into an Accelerated Share Repurchase program with Bank of America (BAC) to repurchase $220M of common stock under its current share repurchase authorization. Prior to this repurchase program, FLEETCOR had repurchased 1,769,954 shares for $345.4M in 4Q18. Including the shares expected to be repurchased in the ASR program announced, FLEETCOR will have repurchased approximately 3M shares in Q4, and a total of approximately 4.9M shares in 2018. These repurchases represent a substantial return of capital to shareholders by reducing outstanding shares by approximately 5.5%, or $946M, since December 31, 2017. The company expects to fund the repurchase with a combination of debt and cash. Approximately 85% of the shares expected to be repurchased under the transaction will be received by FLEETCOR on December 18, 2018. The total number of shares ultimately repurchased under the program will be determined upon final settlement and will be based on a discount to the volume-weighted average price of FLEETCOR's common stock during the ASR period. FLEETCOR anticipates that all repurchases under the ASR will be completed by the end of 1Q19. Subsequent to completion of this ASR, FLEETCOR is expected to have approximately $64M remaining under its current repurchase authorization.
DAR

Hot Stocks

08:16 EDT Darling Ingredients opens new organic fertilizer plant in Turlock, CA - Darling Ingredients announces the opening on January 2, 2019, of its second organic fertilizer production facility in Turlock, CA. The new state-of-the-art facility is located on a 21-acre site and will have the ability to annually produce 35,000 tons of Nature Safe Natural & Organic Fertilizer. The new plant will also provide 4,500 tons of storage capacity to meet the needs of organic growers operating in California and the entire western region of the United States. Darling has operated Nature Safe out of its original Henderson, Kentucky plant since the early 1990's, where it will continue to produce its premium fertilizer for customers in the rest of the country. The strength of the organic fertilizer market in the western U.S. has Nature Safe already working on plans to double the new Turlock plant's production capacity by end of year 2019.
RMED

Hot Stocks

08:14 EDT Ra Medical Systems appoints Thomas Fogarty as Chief Commercial Officer - Ra Medical Systems hires Thomas Fogarty as Chief Commercial Officer, effectively immediately. Fogarty brings over two decades of medical device leadership and commercialization experience to Ra Medical Systems and will oversee all aspects of the company's commercialization efforts, which include the sales and marketing of its proprietary excimer laser systems that treat tough vascular and dermatological diseases.
AMCN

Hot Stocks

08:13 EDT AirMedia provides update on CEO Man Guo's share purchase plan - AirMedia Group announced that its Chairman and CEO Herman Man Guo had proceeded with his previously announced share purchase plan, which was previous announced by the company on March 28, 2018 and updated on September 28, 2018. As of December 14, 2018, Guo had purchased an aggregate of 228,352 American depositary shares over the period of Dec. 7, 2018 to Dec. 14, 2018 at an average purchase price of approximately 25c per ADS.
XENT

Hot Stocks

08:13 EDT Intersect ENT enrolls first patient in ASCEND study - Intersect ENT announced the enrollment of the first patient in the company's study of its newest platform product, the ASCEND investigational drug-coated sinus balloon. This novel device is designed to deliver a corticosteroid directly to the sinuses at the time of dilation. Intersect ENT expects to report top line results by the end of 2019.
INNT

Hot Stocks

08:12 EDT Innovate evaluates proposals for first ever Phase 3 trial in celiac disease - Innovate Biopharmaceuticals will evaluate various funding proposals for commencing the first ever Phase 3 registration trial for celiac disease. Celiac disease affects approximately 1% of the U.S. population, more than 3M Americans, and is a high unmet need with no FDA approved treatments available.
URGN

Hot Stocks

08:12 EDT UroGen Pharma initiates rolling submission of NDA for UGN-101 - UroGen Pharma announced that it has initiated the rolling submission with the U.S. Food and Drug Administration of the New Drug Application for UGN-101 for instillation as a treatment for patients with low-grade upper tract urothelial cancer. The company expects to complete its NDA submission by mid-2019, with potential approval in 2019. The NDA submission is supported by clinical data from the Phase 3 OLYMPUS clinical trial of UGN-101 for the non-surgical treatment of LG UTUC. Results from an interim analysis were presented at the American Urologic Association Annual Meeting in May 2018. UroGen plans to present topline data from the OLYMPUS study in January 2019. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.
AJG

Hot Stocks

08:11 EDT Arthur J. Gallagher acquires Preston-Patterson Co., terms not disclosed - Arthur J. Gallagher & Co. announced the acquisition of Conshohocken, Pennsylvania-based Preston-Patterson Co. Terms of the transaction were not disclosed. Founded in 1947, Preston-Patterson is a retail property/casualty insurance broker offering a broad range of coverages and services to broadcasters and media clients throughout the United States.
SGMO

Hot Stocks

08:10 EDT Sangamo says first patient treated in Phase 1/2 clinical trial evaluating SB-FIX - Sangamo Therapeutics announced treatment of the first patient in the Phase 1/2 clinical trial evaluating SB-FIX, an investigational in vivo genome editing therapy for patients with hemophilia B.
LION

Hot Stocks

08:10 EDT Fidelity Southern trading halted, news pending
TOWR

Hot Stocks

08:09 EDT Tower International announces retirement of COO Mike Rajkovic - Tower International announced the retirement of COO, Mike Rajkovic. Consistent with a leaner regional business footprint resulting from the pending divestiture of its European Operations, the Company and Rajkovic have mutually agreed to accelerate his planned retirement from Tower.
NDAQ NRC

Hot Stocks

08:08 EDT Nasdaq, NRC Health announce partnership between businesses - The Governance Institute, a service of NRC Health (NRC), announced a new partnership with Nasdaq Governance Solutions, a business of Nasdaq (NDAQ), to provide members of The Governance Institute with access to Nasdaq Boardvantage, a board portal and collaboration software solution. Nasdaq Boardvantage is designed with security features to help executive administrators, board members and leadership teams achieve their meeting management and governance needs.
TLRY

Hot Stocks

08:08 EDT Tilray signs LOI to purchase hemp-derived CBD from LiveWell Canada - Tilray announced the terms of a binding letter of intent to purchase hemp-derived CBD isolate from LiveWell Canada, which will be sourced from the United States and Canada and utilized for distribution of Tilray-owned wellness and medical products across North America. The LOI outlines that LiveWell will supply Tilray with CBD isolate made from hemp cultivated and processed in the U.S. and Canada, with first supply commencing in February 2019. The CBD isolate will be used to process finished CBD cannabis products for distribution by Tilray in Canadian and U.S. markets, subject to applicable federal and local laws and regulations. As outlined in the terms of the LOI, LiveWell will ensure the hemp-derived CBD isolate supplied to Tilray adheres to strict quality standards, including Good Production Practice. Prior to distribution, Tilray will ensure that all finished products adhere to applicable law, as well as its internal quality standards.
SPHS

Hot Stocks

08:08 EDT Sophiris Bio provides update on Phase 2b localized prostate cancer trial - Sophiris Bio provides an update from its Phase 2b study of topsalysin for localized prostate cancer, including top-line safety and biopsy results from the patients who received a second administration of study drug, which appeared to be safe and generally well-tolerated. Additional benefit was not observed on targeted biopsy six months after re-treatment with a second administration of topsalysin. As previously stated, a total of 27% of patients demonstrated a clinical response six months following a single administration of topsalysin. Six of the ten clinical responders experienced a complete ablation of their tumor. Based on these results, the company is moving forward with its plans to propose a single Phase 3 registration trial design using a single administration of topsalysin, which it will discuss with regulatory agencies in the coming months.
EIGR

Hot Stocks

08:06 EDT Eiger: FDA grants Breakthrough Therapy designation for lonafarnib - Eiger BioPharmaceuticals announced that the FDA has granted Breakthrough Therapy designation for lonafarnib for the treatment of hepatitis delta virus infection. FDA Breakthrough Therapy designation involves a Fast Track development and FDA review process with guidance designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases. HDV is the most severe form of human viral hepatitis and has no approved treatment. Lonafarnib is a first-in-class prenylation inhibitor for the treatment of HDV infection.
ARLP

Hot Stocks

08:06 EDT Alliance Resource Partners to acquire oil, gas mineral interests for $175.96M - Alliance Resource Partners announced that it has entered into definitive agreements to acquire the general partner interests in AllDale Minerals and AllDale Minerals II and all of the limited partner interests in AllDale not currently owned by ARLP's affiliate, Cavalier Minerals JV. ARLP also announced that it has begun development of the Excel Mine No. 5, an extension of its MC Mining operation in Pike County, Kentucky. Currently, ARLP owns a 96% interest in Cavalier, which owns approximately 72% of the limited partner interest in AllDale. Upon closing the transaction, ARLP will own 100% of the general partner and approximately 97% of the limited partner interests in AllDale, therefore controlling approximately 42,000 net royalty acres strategically positioned in the core of the Anadarko, Permian, Williston and Appalachian basins. The acquired acreage is concentrated in the SCOOP/STACK, Delaware Basin, Midland Basin, Bakken and Appalachian Basin. The acquired acreage position will provide ARLP with diversified exposure to industry-leading operators. ARLP will acquire the Partnership Interests for a cash purchase price of $175.96M, which will be funded with cash on hand and borrowings under its credit facility. The agreements provide for an effective date of November 1, 2018 and the transaction is expected to close in early January 2019. In addition, ARLP also owns approximately 3,950 net royalty acres through its limited partner interest in AllDale Minerals III, LP. ARLP has begun development activity for the Excel Mine No. 5 and currently anticipates deploying total capital of approximately $45M to $50M over the next 18 to 24 months. ARLP's subsidiary, MC Mining, controls the estimated 15 million tons of coal reserves assigned to the Excel Mine No. 5 and will own the new mining complex, and our Excel Mining, subsidiary will conduct all mining operations. The underground operation will utilize continuous mining units employing room-and-pillar mining techniques and annual production capacity is expected to be approximately 1.3 million tons of high BTU, low-sulfur coal.
PFE

Hot Stocks

08:05 EDT Kineta unit enters license agreement with Pfizer to develop cancer treatment - Kineta Immuno-Oncology, a subsidiary of Kineta, announced that it has entered into a strategic research collaboration with Pfizer to develop RIG-I agonist immunotherapies for the treatment of cancer. The research collaboration and license agreement grants to Pfizer the exclusive rights to KIO's RIG-I screening platform and related compounds and technologies. The companies will collaborate to develop and test small molecule agonists that target RIG-I, an innate immunostimulatory pathway that can elicit immunogenic cell death in tumors, providing both direct tumor cell killing and enhanced anti-tumor immune responses. Under the terms of the agreement, KIO will receive a $15M upfront payment and will be eligible to receive up to $505M in potential research, development and sales milestone payments. Additionally, KIO is eligible to receive tiered royalties on net sales. Pfizer will fund RIG-I target-related research conducted by Kineta for an initial period of three years, after which Pfizer will be responsible for further development and commercialization of product candidates.
KTOS

Hot Stocks

08:04 EDT Kratos Defense receives $5.2M in specialized product awards - Kratos Defense announced that it has recently received approximately $5.2M in specialized product awards in support of certain C5ISR programs. Kratos provides specialized systems and products in support of unmanned aerial drone, ballistic missile defense, missile, radar, communication and other platforms and systems. Work under these new contract awards will be performed in secure Kratos manufacturing facilities. Due to customer related, competitive and other considerations, no additional information will be provided related to these recent contract awards.
CLGX

Hot Stocks

08:04 EDT CoreLogic acquires HomeVisit - CoreLogic announced the company has completed the acquisition of HomeVisit from Breakaway Holdings, LLC. HomeVisit is a provider of marketing focused real estate solutions, including property listing photography, videography, 3D modeling, drone imagery, and related services. HomeVisit currently operates in the mid-Atlantic region and, when combined with CoreLogic workflow platforms serving over 800,000 real estate professionals, is expected to enable the next generation of property marketing solutions for real estate professionals, Multiple Listing Services, Brokers and agents across North America.
NXTD

Hot Stocks

08:03 EDT Nxt-ID says proposed spin-off of payments division delayed - Nxt-ID announced that the proposed spin-off of its payment and other assets into an independent publicly traded company and distribution of shares of the new company to Nxt-ID shareholders has been delayed. Nxt-ID intends to proceed with the spin-off and to establish a new record date for the transaction in the first quarter of 2019. Shares of NXT-ID are currently trading with all the rights of shareholders of Nxt-ID common stock, including the right to receive dividends and distributions as determined by the Board of Nxt-ID. "The reason for the delay in completing the transaction is that, after much effort, we were unable to come to terms with our primary lender regarding the release of their security interest in assets that we are proposing to spin off," said Gino Pereira, Chief Executive Officer of Nxt-ID. "We are currently working with a number of other lenders to replace the existing long-term facility to remove the security interest. We will announce a new record date when we have better clarity on the timing to complete the transaction and to receive various regulatory approvals. We are now targeting to conclude the spin-off before the end of the first quarter of 2019."
ARTH

Hot Stocks

08:00 EDT Arch Therapeutics receives 510 clearance from FDA for AC5 Topical Gel - Arch Therapeutics announced that the 510 premarket notification for AC5 Topical Gel has been reviewed and cleared by the FDA, allowing for the product to be marketed. AC5 Topical Gel is a topical dressing indicated for use in the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds.
KCAP

Hot Stocks

08:00 EDT KCAP Financial trading resumes
NVO

Hot Stocks

07:59 EDT Novo Nordisk, Staten Biotechnology announce dyslipidaemia collaboration - Staten Biotechnology B.V. and Novo Nordisk announced that they have entered into a collaboration and exclusive option agreement to develop novel therapeutics for the treatment of hypertriglyceridaemia. Under the collaboration agreement, Novo Nordisk will provide research and development funding and support for Staten to develop its lead asset STT-5058 for treatment of dyslipidaemia. Under the exclusive option agreement, Novo Nordisk has the right to acquire Staten Biotechnology and gain worldwide rights to STT-5058. Staten Biotechnology and its shareholders will potentially receive signing and exercise fees, R&D funding, and milestone payments of up to 430M euros.
SPHS

Hot Stocks

07:54 EDT Sophiris Bio trading halted, news pending
CGIX

Hot Stocks

07:54 EDT Cancer Genetics trading halted, news pending
KCAP

Hot Stocks

07:53 EDT KCAP Financial announces 67c per share transaction agreement with BC Partners - KCAP Financial announced that it has entered into a stock purchase and transaction agreement with private equity firm BC Partners, whereby an affiliate of BC Partners will become the external manager of KCAP. Under the terms of the agreement, if the new advisory agreement is approved by stockholders and the other conditions to closing are satisfied, stockholders will receive a direct cash payment from an affiliate of BC Partners of $25M, or approximately 67c per share. In addition, BC Partners has agreed to contribute up to 100% of incentive fees earned, if necessary, to achieve net investment income of 40c per share for a one-year period after closing and to use up to $10M of the incentive fees it earns to purchase newly-issued KCAP common stock over the next two years at a price equal to net asset value per share at the time of the purchases. On November 8, KCAP agreed to sell its asset manager affiliates to LibreMax Capital. LibreMax will take a minority stake in the BC Partners affiliate that will act as the external manager of KCAP.
MOH

Hot Stocks

07:53 EDT Molina Healthcare comments on recent ACA ruling - Molina Healthcare issued the following statement with respect to the recent ruling on the Affordable Care Act by the U.S. District Court for the Northern District of Texas: "While we are disappointed in the recent Northern District of Texas court's ACA ruling, we recognize that this is a first step in what will be a lengthy appeals process. Regardless, the ACA will remain in effect for 2019, and we are optimistic that it will remain in effect thereafter. We support efforts by Congress and the Administration to stabilize the ACA's programs and ensure continued protection of Americans with pre-existing conditions."
VRNT

Hot Stocks

07:51 EDT Verint to acquire ForeSee - Verint Systems announced the signing of a definitive agreement to acquire ForeSee, a cloud voice of the customer vendor. The Verint-ForeSee combination will create the market's most comprehensive omnichannel cloud VoC portfolio available-an analytics-rich offering that will allow organizations to better measure and understand customer experiences and prioritize the improvements that will have the greatest business impact. The acquisition will add ForeSee's causal modeling, predictive analytics and benchmarking to Verint's existing omnichannel VoC portfolio. The combination will create a new standard for customer experience, marketing and operational executives who want a unified view of the voice of their customers across digital, voice, surveys, email, chat and social media. Both Verint and ForeSee customers will benefit from an innovative vision, backed by the resources and commitment to building the next generation of VoC solutions for organizations looking to elevate their customer experience.
ALKS BIIB

Hot Stocks

07:48 EDT Alkermes, Biogen announce diroximel fumarate NDA submitted to FDA - Alkermes (ALKS) and Biogen (BIIB) announced that Alkermes has submitted a new drug application, or NDA, to the U.S. FDA for diroximel fumarate, a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis, or MS. Alkermes is seeking approval of diroximel fumarate under the 505 regulatory pathway, and the NDA submission includes data from EVOLVE-1, a Phase 3 pivotal trial that evaluated long-term safety in relapsing-remitting MS, or RRMS, with approximately 700 patients dosed with diroximel fumarate. If approved, Biogen intends to market diroximel fumarate under the brand name Vumerity. This name has been conditionally accepted by the FDA and will be confirmed upon approval.
TRP

Hot Stocks

07:45 EDT TransCanada to sell Coolidge Generating Station for $465M - TransCanada announced that it has entered into an agreement to sell its Coolidge Generating Station to SWG Coolidge Holdings, a wholly owned subsidiary of Southwest Generation Operating, for approximately $465M, subject to closing adjustments and customary regulatory approvals. Located in Coolidge, Arizona, the Coolidge Generating Station is a 575-megawatt natural gas-fired power facility that is underpinned by a long-term power purchase agreement, or PPA. When combined with the sale of Cartier Wind and the reimbursement of pre-development costs on the Coastal GasLink pipeline project earlier this year, the company expecta to realize approximately $1.7B that will be used to help fund near-term capital program. Under the terms of the PPA, Salt River Project Agricultural Improvement and Power District, the counterparty to the agreement, has a right of first refusal on a sale to a third party, which will determine next steps in the sale and closing process.
DOVA UTHR

Hot Stocks

07:41 EDT Dova Pharmaceuticals CEO Alex Sapir removed, David Zaccardelli to succeed - Dova Pharmaceuticals (DOVA) announced that David Zaccardelli has been appointed president and CEO. Zaccardelli brings specialty pharmaceutical executive leadership and operational expertise, including most notably, serving in several senior management roles at United Therapeutics (UTHR). In addition, Jason Hoitt, a seasoned pharmaceutical sales and marketing executive, joins Dova as CCO. Alex Sapir, the company's prior president and CEO, is no longer president and CEO, effective as of December 16.
TZOO

Hot Stocks

07:36 EDT Travelzoo to open office in Milan, Italy, sees increase in Q4 profitability - Travelzoo announced that it will shortly open a sales office in Milan, Italy. Travelzoo's office will be located at Via Bernardino Luini 7, 20123 Milan. Management expects the new sales office to make a quick positive impact on Travelzoo's operating income. For the current fourth quarter, the company expects to report a significant year-over-year increase in profitability.
TRN

Hot Stocks

07:36 EDT Trinity Industries CFO James Perry to depart - Trinity Industries announced that James Perry, the company's current SVP and CFO, has notified the company of his decision to transition from employment with the company to pursue other opportunities. Perry will remain in the CFO role until Trinity has filed its Annual Report on Form 10-K for the year ended December 31, 2018. The company plans to enter into a transition agreement with Perry consistent with the terms of Trinity's executive officers' Transition Compensation Plan. The company also announced that Melendy Lovett will assume the role of SVP and CFO following the filing of the company's 2018 Form 10-K. Lovett's current role with the company is SVP and chief administrative officer, and she has oversight of the company's railcar leasing business. Lovett also led the company's recent spin-off of Arcosa to Trinity's shareholders. Upon Lovett's assumption of the CFO role, Relle Howard, the company's VP and chief information officer will assume the role of Trinity's chief administrative officer.
TGTX

Hot Stocks

07:35 EDT TG Therapeutics announces publication of Phase 1/1b umbralisib results - TG Therapeutic and Dana-Farber Cancer Institute announced the publication of results from the multicenter Phase 1/1b trial of umbralisib, TG Therapeutics' once-daily PI3K delta inhibitor, in combination with ibrutinib, the oral Bruton's tyrosine kinase, or BTK, inhibitor, in Lancet Haematology. This investigator-initiated trial was conducted at Dana-Farber Cancer Institute and four additional academic and community sites across the USA in collaboration with the Leukemia and Lymphoma Society Blood Cancer Research Partnership with funding by TG Therapeutics. The publication includes safety and efficacy information from a total of 42 relapsed or refractory patients, 21 with chronic lymphocytic leukemia, or CLL, and 21 with mantle cell lymphoma, or MCL. In this study, the combination of umbralisib and ibrutinib was well tolerated and consistent with the additive toxicity profile of the two drugs individually. No dose-limiting toxicities were observed, and the maximum-tolerated dose of umbralisib when combined with ibrutinib was not reached. The recommended phase 2 dose of umbralisib when given in combination with ibrutinib was 800 mg once daily. Importantly, serious immune-mediated toxicities were not observed with this combination, as had previously been reported with combinations of different agents targeting this pathway, with only one case of transient Grade 3 transaminitis and no Grade 3/4 colitis or pneumonitis. The combination of umbralisib and ibrutinib was also clinically active, with 90% of relapsed/refractory CLL patients achieving an overall response, of which 62% achieved a partial response or partial response with lymphocytosis, and 29% achieved a complete response. Of the 21 patients treated with MCL, 67% achieved an overall response, of which 48% achieved a partial response and 19% achieved a complete response.
JACK

Hot Stocks

07:35 EDT Jack in the Box trading resumes
ITP

Hot Stocks

07:34 EDT IT Tech Packaging announces launch of tissue paper production - IT Tech Packaging announced the commercial launch of tissue paper production, following the completion of construction and equipment installation, the receipt of proper approvals, including wastewater discharge permit, from local authorities, and the success of trial production of its first tissue paper production line. The PM8 Production Line is located at Wei County Industrial Park in Hebei Province, China, with annual production capacity of 15,000 tonnes. The company also plans to start the construction of another tissue paper production line with annual production capacity of additional 15,000 tonnes in the next several months.
ALKS BIIB

Hot Stocks

07:32 EDT Alkermes; Biogen: Alkermes submits NDA to FDA for diroximel fumarate - Alkermes (ALKS) and Biogen (BIIB) announced that Alkermes has submitted a New Drug Application to the U.S. FDA for diroximel fumarate, a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis. Alkermes is seeking approval of diroximel fumarate under the 505(b)(2) regulatory pathway, and the NDA submission includes data from EVOLVE-1, a phase 3 pivotal trial that evaluated long-term safety in relapsing-remitting MS with approximately 700 patients dosed with diroximel fumarate. If approved, Biogen intends to market diroximel fumarate under the brand name VUMERITY. This name has been conditionally accepted by the FDA and will be confirmed upon approval.
BVX

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07:32 EDT Bovie Medical appoints Tara Semb as CFO - Bovie Medical Corporation announced the appointment of Tara Semb as CFO, effective January 2, 2019. Prior to joining Bovie Medical, Semb was the CFO for AVAIL Vapor, a manufacturer and retailer of e-liquid for use in electronic vapor devices, from 2015 until 2018.
SYF

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07:32 EDT Synchrony reports November net charge-off rate 4.64% vs. 4.85% last month - Reports November 30-plus day delinquencies 2.91% vs,. 2.95% last month.
JPM

Hot Stocks

07:31 EDT JPMorgan reports November net credit losses 2.26% vs. 2.19% last month - Reports November 30-plus day delinquency rate 1.19% vs. 1.18 last month.
ADS

Hot Stocks

07:30 EDT Alliance Data reports November net charge offs 5.5% vs. 5.7% last month - Reports November delinquency rate 5.7% vs. 5.8% last month
COF

Hot Stocks

07:30 EDT Capital One reports November net charge-offs 4.72% vs. 4.25% last month - Reports November 30-plus day performing delinquencies 4.08% vs. 3.99% last month.
SLGL

Hot Stocks

07:28 EDT Sol-Gel Technologies initiates Phase 3 TWIN clinical program - Sol-Gel Technologies announced dosing of the first subject in the pivotal Phase III clinical program evaluating the safety and efficacy of TWIN in subjects with acne vulgaris. TWIN is a cream containing a fixed-dose combination of encapsulated tretinoin and encapsulated benzoyl peroxide using Sol-Gel's proprietary microencapsulation platform. The program consists of two randomized, double-blind, vehicle-controlled Phase III clinical trials. Each pivotal trial is planned to enroll approximately 420 subjects aged 9 and above at a 2:1 ratio, with a power of 99%. The objective of the study is to evaluate the efficacy and safety of TWIN, a topical cream containing encapsulated tretinoin and encapsulated benzoyl peroxide, compared to vehicle when applied once daily for 12 weeks in patients with moderate-to-severe acne vulgaris. The pivotal TWIN clinical program is being executed under a special protocol assessment, or SPA, agreement with the FDA. The SPA provides agreement that the study design, clinical endpoints and statistical analysis approach for Sol-Gel's Phase III program evaluating TWIN for the treatment of patients with acne vulgaris will be deemed adequate to support an NDA filing for marketing approval.
ACHC

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07:25 EDT Acadia chairman, CEO removed by board, Debbie Osteen named CEO - Acadia Healthcare (ACHC) announced that Debbie Osteen, former President of the Behavioral Health Division of Universal Health Services (UHS), has joined Acadia as CEO. She replaces Joey Jacobs, who has been removed by the board from his roles as CEO and chairman of the board. Reeve Waud, Lead Director of Acadia's board, has been elected chairman of Acadia.
KCAP

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07:25 EDT KCAP Financial trading halted, news pending
MTL

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07:24 EDT Mechel expands sales agreement for coking, thermal coal with Itochu Corporation - Mechel reported expansion of the sales agreement with a Japanese universal trading company Itochu Corporation. The agreement stipulates that Mechel and Itochu Corporation agreed on potential sales of up to 800,000 tonnes of coking and thermal coal between December and March 2020. The coal will be shipped from Mechel's Southern Kuzbass Coal Company and Elgaugol. The price will be determined by mutual agreement. Japan's major consumers and Asian steelmaking and power facilities will be the end consumers of Mechel's products.
NSANY...

Hot Stocks

07:23 EDT Nissan forms special committee on governance, continues talks on chairman role - The Nissan Motor (NSANY) board of directors approved the establishment of the Special Committee for Improving Governance. The board also acknowledged ongoing discussions regarding the nomination for the position of chairman of the board and reaffirmed its ongoing efforts to fully inform its Alliance partners Renault (RNSDF) and Mitsubishi Motors Corporation (MMTOF). The company said, "On Nov. 22, the board approved the study of the creation of a committee to receive advice from an independent third party regarding governance management and enhanced governance of director compensation. Following that mandate, the three independent outside directors - Masakazu Toyoda, Keiko Ihara and Jean-Baptiste Duzan - led the study. The board resolved to establish the Special Committee for Improving Governance, incorporating external independent experts based on the recommendations of the independent outside directors. Taking into account the results of the investigation into acts of serious misconduct by the former Nissan chairman and former representative director, the Special Committee for Improving Governance aims to find the root causes and provide recommendations for the enhancement of the company's governance, including proposals to improve approval processes and governance for determining director compensation and to provide recommendations for creating a healthy state of governance as the foundation for sustainable business in a leading global company...On Nov. 22, the board approved the establishment of an advisory committee that will propose nominations from the board for the position of chairman. The committee is composed of Masakazu Toyoda who chairs the committee, Keiko Ihara and Jean-Baptiste Duzan. The board received and acknowledged the report from the committee that the committee will continue its discussions...Nissan continues its efforts to keep its Alliance partners fully informed. At the board meeting of Mitsubishi Motors, Nissan presented a full briefing of the conduct of the former Nissan chairman and representative director. Nissan today reaffirms to Renault its readiness at any time to provide a full briefing at a Renault board meeting in order to maintain an equal understanding among the Alliance partners." Reference Link
GTE

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07:22 EDT Gran Tierra sees FY19 production of 40,000-42,000 boepd - Gran Tierra expects FY19 average production of 40,000-42,000 boepd, representing organic growth of 12%-18% over average production in the first nine months of 2018 and an increase of 27%-34% over 2017 average production. Guidance represents an average production growth rate of approximately 15% per year since 2015 and includes only forecasted volumes from existing operations and expected development and appraisal projects, with no volumes assumed for any exploration success including Pomorroso-1. Sees FY19 capital budget of $350M-370M and FY19 cash flow of $365M-375M.
CRBP

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07:18 EDT Corbus Pharmaceuticals initiates Phase 3 DETERMINE trial - Corbus Pharmaceuticals announced the start of the company's Phase 3 trial DETERMINE, designed to evaluate the efficacy and safety of its investigational drug lenabasum for the treatment of dermatomyositis, or DM. The Phase 3 study design is consistent with guidance from the FDA at an end-of-Phase 2 meeting, formal consultation with Japanese regulatory authorities, or PMDA, and scientific advice from European regulatory authorities. Dermatomyositis is a rare and serious multisystem inflammatory autoimmune disease that characteristically affects muscle and skin and can also involve the lungs, heart, joints and gastrointestinal tract. The disease is characterized by significant morbidity, disability and mortality despite the current standard-of-care treatment with corticosteroids or other immunosuppressive medications.
SHPG

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07:16 EDT Shire announces FDA approval of Motegrity for treatment of CIC - Shire announced that the FDA has approved Motegrity, a once-daily, oral treatment option for adults with Chronic Idiopathic Constipation, or CIC. Motegrity, a selective serotonin-4, or 5-HT4, receptor agonist, provides a different class of treatment for CIC that works by enhancing colonic peristalsis to increase bowel motility. Motegrity is expected to launch in 2019 in the United States, where an estimated 35M adults are living with CIC. While not all patients may be right for treatment, Motegrity represents a new option. The efficacy of once-daily treatment with Motegrity was evaluated in six double-blind, placebo-controlled, randomized, multicenter clinical studies lasting 12 weeks or 24 weeks. Of the 2,484 patients, most were female and caucasian, with an average age of 47. During studies, significantly more patients taking Motegrity achieved the primary endpoint than those in the placebo group across five of six trials. A rapid response was seen with Motegrity as early as week 1, with improvements maintained throughout 12 weeks of treatment. The FDA has requested that Shire conduct five post-marketing studies evaluating the pharmacokinetics, efficacy and safety of Motegrity in pediatric patients with CIC and pregnant and lactating women with CIC treated with Motegrity. Motegrity is contraindicated in patients with a history of hypersensitivity to Motegrity. Reactions include dyspnea, rash, pruritus, urticaria and facial edema have been observed. Motegrity is also contraindicated in patients with intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn's disease, ulcerative colitis and toxic megacolon/megarectum. In clinical trials, suicides, suicide attempts, and suicidal ideation have been reported. A causal association between treatment with Motegrity and an increased risk of suicidal ideation and behavior has not been established. Most common adverse reactions are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence and fatigue. Overall, discontinuation due to adverse events was low. If reported, adverse events of diarrhea or headache typically resolved within a few days. In addition, cardiovascular safety was evaluated in a MACE analysis of the double-blind, placebo-controlled and open-label studies. It was also assessed in a retrospective observational study, which demonstrated no increase in the risk of MACE with Motegrity relative to polyethylene glycol.
CAPL

Hot Stocks

07:07 EDT CrossAmerica, Couche-Tard to exchange $184.5M in assets - Alimentation Couche-Tard, through Circle K Stores Inc., its wholly-owned subsidiary, and CrossAmerica announced an agreement to exchange assets in a series of transactions. Couche-Tard has agreed to sell to CrossAmerica 192 U.S. company-operated convenience and fuel retail stores having an aggregate value of approximately $184.5M. CrossAmerica has agreed to sell to Couche-Tard assets having an aggregate value of approximately $184.5M. These CrossAmerica assets include the real estate property for 56 U.S. company-operated convenience and fuel retail stores currently leased and operated by Couche-Tard pursuant to a master lease that CrossAmerica previously purchased jointly with or from CST Brands and 17 company-operated convenience and fuel retail stores currently owned and operated by CrossAmerica located in the U.S. upper Midwest. The existing fuel supply arrangements for the 56 master lease properties will remain unchanged. It is expected that the exchange of assets will occur in a series of transactions over a period of up to 24 months. The Circle K retail stores to be sold to CrossAmerica will remain at Couche-Tard until dealers are secured to operate the sites. The process is already underway to identify qualified dealers and the first transaction is anticipated to occur in the first half of calendar year 2019. It is expected that there will be no additional funding required as part of these transactions. CrossAmerica also expects these transactions will be accretive to distributable cash flow to its limited partners. The asset exchange agreement was approved by the CrossAmerica board of directors following the approval of the terms of the transaction by its independent conflicts committee.
CSIQ

Hot Stocks

07:07 EDT Canadian Solar, TrailStone sign 10-year PPA for solar portfolio in Italy - Canadian Solar and TrailStone announced they entered into a 10-year power purchase agreement for the electricity produced by a 17.6 MWp solar PV plant portfolio in Sicily, Italy. The portfolio is jointly owned by Canadian Solar (51% stake) and Manni Energy (49% stake), a renewable energy company devoted to engineering, O&M services, and energy efficiency and part of Manni Group, which will also provide turnkey EPC services for the project. This landmark PPA will cover 100% of the electricity generated and is believed to be the longest-term PPA for a fully unsubsidized solar PV portfolio signed to date in Italy. The PPA provides stable and predictable power sales revenues via a fixed price floor but also higher generation-weighted power prices due to an upside-sharing mechanism. As part of the agreement, TrailStone will also act as market representative for the portfolio on the Italian wholesale market. The solar PV portfolio is expected to start producing electricity in the second quarter of 2019. The expected production is approximately 34 GWh per annum, equivalent to the annual consumption of 12,000 households in Italy.
JACK

Hot Stocks

07:06 EDT Jack in the Box exploring strategic, financing alternatives - Jack in the Box announced that its Board of Directors and management team, with the support of legal and financial advisors, is exploring a range of strategic and financing alternatives to maximize shareholder value. Potential alternatives could include, among other things, a sale of the company or executing on the company's previously announced plans to increase its leverage. The company's Board has not set a timetable for the conclusion of this process nor has it made any decision related to any strategic or financing alternative at this time. The company has had discussions with potential buyers; however, it noted that there can be no assurance that the exploration of strategic and financing alternatives will result in a transaction. That said, in the absence of a strategic transaction the company remains committed to its previously communicated plan to have a new capital structure in place by the end of 1H19. That capital structure could include, among other things, a securitization or bond issuance. The company does not intend to comment further regarding the review unless or until it determines that further disclosure is appropriate or required by law.
TGT

Hot Stocks

07:05 EDT Target says eligible Target.com orders will be delivered for free by Xmas Eve - Target is taking the stress out of the season for last-minute shoppers by guaranteeing eligible Target.com orders will be delivered for free by Christmas Eve.
CNCE

Hot Stocks

07:04 EDT Concert Pharmaceuticals initiates Phase 1 clinical program of CTP-692 - Concert Pharmaceuticals announced that it has initiated its Phase 1 clinical program for CTP-692, which is being developed as a novel adjunctive treatment for schizophrenia, a devastating, chronic illness with significant unmet need. CTP-692 is a deuterated form of D-serine, an endogenous co-agonist of the N-methyl-D-aspartate receptor, which has been demonstrated to be important to mood, memory, and cognition. Concert's Phase 1 program will include a crossover pharmacokinetic comparison of CTP-692 to D-serine and single- and multiple-ascending dose studies to assess the safety, tolerability and pharmacokinetic profile of CTP-692 in healthy volunteers. Initial Phase 1 data are expected in the first quarter of 2019. The Phase 1 program is expected to enroll approximately 80 healthy volunteers. Dosing has been initiated to assess the safety, tolerability, and pharmacokinetics of a single oral dose pharmacokinetic comparison of CTP-692 versus D-serine. Following successful completion of the crossover trial, Concert will assess the safety, tolerability, and pharmacokinetics of single-ascending oral doses of CTP-692 in a double-blind, placebo-controlled trial. The Phase 1 program will also assess multiple doses of CTP-692 dosed orally over several days in a double-blind, placebo-controlled, multiple-ascending dose trial. The CTP-692 clinical program is supported by Concert's preclinical studies which have shown the potential for CTP-692 to improve upon the safety profile of D-serine. D-serine has been shown to cause nephrotoxicity in published preclinical studies. Concert's preclinical studies have demonstrated that selective deuterium modification resulted in increased exposure of CTP-692 relative to a similar dose of D-serine, and administration of CTP-692 resulted in no changes in serum creatinine and blood urea nitrogen at doses where D-serine caused substantial nephrotoxicity assessed by these kidney markers.
PTI RHHBY

Hot Stocks

07:03 EDT Proteostasis announces global license agreement with Genentech - Proteostasis Therapeutics (PTI) announced a worldwide, exclusive license agreement with Genentech, a member of the Roche Group (RHHBY), for rights to potential therapeutic small molecule modulators of an undisclosed target within the proteostasis network. The agreement does not include cystic fibrosis transmembrane conductance regulator modulators and is unrelated to PTI's investigational medicines or other ongoing research programs in cystic fibrosis. Under the terms of the agreement, in exchange for rights to these small molecule modulators, Proteostasis is eligible to receive upfront and milestone payments of over $100M. In addition, Proteostasis is eligible to receive tiered royalties on sales of medicines resulting from the license agreement. Genentech is responsible for all further research and development expenses related to the program. Full financial terms, the therapeutic target and disease areas of focus are not disclosed.
AZN

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07:02 EDT Pyramid Biosciences announces global license of AstraZeneca TRK program - Pyramid Biosciences announced it has entered into an exclusive, worldwide licensing agreement with AstraZeneca for the development and commercialization rights to a novel Tropomyosin receptor kinase modulator, PBI-100. Pyramid Biosciences seeks to develop the TRK modulator for a range of dermatological and inflammatory diseases, including psoriasis and atopic dermatitis. Under the agreement, Pyramid Biosciences licenses exclusive rights to develop and commercialize the compound globally. Financial terms of the agreement were not disclosed.
JACK

Hot Stocks

07:01 EDT Jack in the Box trading halted, news pending
BMY ESALY

Hot Stocks

07:01 EDT Bristol-Myers, H3 Biomedicine announce new research collaboration agreement - Bristol-Myers Squibb (BMY), Eisai Co (ESALY) and its U.S.-based precision medicine research & development subsidiary H3 Biomedicine announced a multi-year research collaboration focused on evaluating whether novel therapeutics leveraging H3's RNA splicing platform can provide a more powerful response against cancer. The new collaboration will explore modulating RNA splicing to develop potential first-in-class therapies that would direct the immune system to target cancer cells and help more patients experience the benefits of immunotherapy. Under the terms of the multi-year agreement, H3 and Bristol-Myers Squibb will jointly conduct the research focused on developing immune therapies using H3's RNA splicing platform. Bristol-Myers Squibb will be responsible for development and commercialization of selected compounds, and H3 is eligible to receive an upfront payment, development, regulatory and sales milestones as well as certain royalties according to sales revenue after launch. Eisai retains an option to co-develop and co-commercialize certain compounds that emerge from the collaborative research effort.
BMY

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07:01 EDT Bristol-Myers announces positive CHMP opinion recommending Sprycel - Bristol-Myers Squibb announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has recommended the expanded approval of Sprycel, in combination with chemotherapy, to include the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia. The positive opinion includes the tablet form of Sprycel and the powder for oral suspension formulation, which was first approved by the European Commission in July 2018, making Sprycel the only tyrosine kinase inhibitor with a formulation developed for administration in pediatric patients and patients who cannot swallow tablets. The CHMP recommendation will now be reviewed by the EC, which has the authority to approve medicines for the European Union.
ZYNE

Hot Stocks

06:57 EDT Zynerba provides update on clinical progress - Zynerba provided an update on its clinical progress. Zynerba remains on track to report top line results from the CONNECT-FX study in Fragile X Syndrome in the second half of 2019; The company has completed enrollment in its Phase 2 BELIEVE 1 clinical trial in children and adolescents with developmental and epileptic encephalopathies. Top-line results will be reported in the third quarter of 2019; Zynerba has expanded its pipeline with the addition of two new childhood neuropsychiatric clinical targets for ZYN002: Autism Spectrum Disorder and 22q11.2 Deletion Syndrome, a rare genetic syndrome leading to significant impairments, including neuropsychiatric disorders. The company expects to initiate open label Phase 2 studies in these indications in the first half of 2019 and report top-line results in first half 2020; The company has postponed the initiation of its clinical trial in adult epilepsy until after the completion of the four childhood neuropsychiatric studies; and As a result, Zynerba expects to extend its cash runway into the second half of 2020.
WFT

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06:55 EDT Weatherford announces $50M sale of surface data logging business - Weatherford announced it has signed a definitive agreement to sell its surface data logging business to Excellence Logging for $50M in cash. As part of the agreement, Weatherford will sell all of its surface data logging equipment, technology and associated contracts and will transfer the related personnel to Excellence Logging. While with this transaction Weatherford will exit the surface data logging business, it plans to continue to maintain a close and collaborative relationship with Excellence Logging to provide bundled and integrated services to its customers including surface data logging. This transaction is designed to maximize Weatherford shareholder value by refocusing the company's portfolio on the businesses most closely aligned with its long-term strategy and is expected to close in the first half of 2019. The transaction is subject to customary closing conditions and the purchase price is subject to customary post-closing working capital adjustments. Upon closing, Weatherford will use the net proceeds to reduce its debt. This transaction is one in a series of planned divestitures that will help deleverage the company's capital structure. During Q3, Weatherford announced the sale of its international land rigs business for $287.5M, of which it has received $215.5M in cash proceeds to date. During Q4, the company also announced an agreement to sell its laboratory services business for $205M in cash.
IDXG

Hot Stocks

06:51 EDT Interpace Diagnostics: USPTO issues notice of allowance for patent on BarreGEN - Interpace Diagnostics announced that a Notice of Allowance has been issued by the United States Patent and Trademark Office for United States Patent Application No. 13/692,727, for methods treating patients with Barrett's metaplasia that are identified as being at high risk to develop esophageal adenocarcinoma. The Patent, when issued, is expected to have a term that expires in 2032.
LLY

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06:50 EDT Eli Lilly announces Taltz meets primary, secondary endpoints in SPIRIT-H2H study - Eli Lilly announced Taltz met the primary and all major secondary endpoints in the Phase 3b/4 SPIRIT-H2H study, which evaluated the efficacy and safety of Taltz versus Humira in patients with active psoriatic arthritis, or PsA, who are biologic disease-modifying anti-rheumatic drug, or DMARD-naive. The SPIRIT-H2H trial is the first completed large head-to-head, or H2H, superiority study in active PsA. This open-label, randomized, controlled trial is the first and only H2H study that utilizes on-label dosing for both Taltz and Humira and includes concomitant conventional DMARDs. At 24 weeks, patients treated with Taltz met the primary endpoint by demonstrating superiority in improving the signs and symptoms of active PsA compared to Humira as measured by the proportion of patients simultaneously achieving at least a 50% reduction in disease activity, as defined by the American College of Rheumatology, or ACR50, as well as complete skin clearance as measured by the Psoriasis area and severity index. In addition, Taltz met the major secondary endpoints. A total of 566 active PsA patients were enrolled in the study to evaluate the efficacy and safety of Taltz compared to Humira. Patients with active PsA were randomized to receive Taltz at the approved dose, or Humira for a total of 52 weeks, with the primary analysis conducted at 24 weeks. Patients meeting criteria for moderate-to-severe plaque psoriasis received the approved dose of Taltz or Humira.
THO

Hot Stocks

06:46 EDT Thor Industries shareholders vote to approve company initiatives - Thor Industries announced that shareholders approved a number of corporate governance enhancements at the annual meeting of shareholders held on December 14, 2018. Shareholders voted to elect Amelia Huntington to the Board of Directors, marking the first female director elected to the Board by the shareholders, which followed her appointment in October. In addition, shareholders approved a proposal to declassify the Board of Directors such that each member of the Board will stand for election each year beginning with the 2019 Annual Meeting.
CDXC

Hot Stocks

06:39 EDT ChromaDex launches TRU NIAGEN in Canada - ChromaDex announced it has officially launched TRU NIAGEN in Canada, having received regulatory approval for sale by Health Canada.
BTE

Hot Stocks

06:37 EDT Baytex Energy says has streamlined executive team - "After completing the merger with Raging River Exploration, we have recently streamlined our executive team with a reduction of three executive officers. In addition, we have consolidated our Peace River and Lloydminster operations into one heavy oil business unit, resulting in an approximate 10% reduction in head office staff and contractors."
BTE

Hot Stocks

06:36 EDT Baytex Energy announces 2019 capital budget of $550M-$650M - Baytex Energy announces that its Board of Directors has approved a 2019 capital budget of $550M-$650M, which is designed to generate average annual production of 93,000-97,000 boe/d. "The 2019 program is approximately 45% weighted to the first half of the year and we have the operational flexibility to adjust our spending plans based on changes in commodity prices. The budget is 90% weighted to drilling and completion activities. Based on the mid-point of our guidance range of 95,000 boe/d, approximately 62% of our production is in Canada with the remaining 38% in the Eagle Ford. Our production mix is forecast to be 83% liquids (46% light oil and condensate, 27% heavy oil and 10% natural gas liquids) and 17% natural gas, based on a 6:1 natural gas-to-oil equivalency."
SGMS

Hot Stocks

06:36 EDT Scientific Games announces three executive promotions - Scientific Games announced three executive promotions. Jim Kennedy, currently executive VP and group CEO, lottery, will become chairman, lottery and Patrick McHugh, who currently serves as senior VP, global lottery systems, has been appointed the lottery's new executive VP and group CEO. In addition, Jordan Levin has been named the new executive VP and group CEO, digital. Levin has experience in interactive, digital gaming and sports betting, and is currently senior VP for corporate development, where he led the acquisition and integration of NYX Gaming Group and previously launched and served as president of SG Interactive. McHugh has lottery experience, having been in the industry for more than 25 years. He has been with Scientific Games for the past 14 years and serves on the leadership executive team as senior VP global lottery systems. McHugh has expertise in gaming systems technology in markets around the world directing complex technology deployments, operations, new business initiatives and strategic product development.
NICE

Hot Stocks

06:34 EDT NICE inContact selected for 2,300 seat cloud transformation - NICE inContact, a NICE business, announced that a global research and technology company that serves customers in more than 130 countries is moving 2300 agents to NICE inContact CXone - the world's #1 cloud customer experience platform - after an exhaustive review of cloud options. The technology innovator, with five divisions spread across more than 20 locations, selected NICE inContact CXone to replace on-premises technology. With CXone advanced application capabilities, the company aims to unify systems, gain agility, and transform customer experience while driving down costs.
PLYM

Hot Stocks

06:33 EDT Plymouth Industrial REIT announces $5M stock repurchase program - Plymouth Industrial REIT announced that the Board of Directors has authorized a stock repurchase plan providing for the purchase in the aggregate of up to $5M of the company's common stock. Plymouth currently has 4,821,876 shares of common stock outstanding. The company anticipates that it will fund the repurchases through proceeds from the recent $75M strategic investment from Madison International Realty.
MRK

Hot Stocks

06:31 EDT Merck: EC approves KEYTRUDA for treatment of stage III melanoma - Merck announced that the European Commission has approved KEYTRUDA, the company's anti-PD-1 therapy, for the adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection. This approval is based on data from the pivotal Phase 3 EORTC1325/KEYNOTE-054 trial, conducted in collaboration with the European Organisation for Research and Treatment of Cancer. An updated recurrence-free survival data analysis, conducted at the request of the European Medicines Agency, demonstrated that KEYTRUDA significantly prolonged RFS, reducing the risk of disease recurrence or death by 44% compared to placebo in the overall population of patients with resected, high-risk stage III melanoma. The approval allows marketing of KEYTRUDA in this new indication in all 28 EU member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every three weeks until disease recurrence, unacceptable toxicity, or for a duration of up to one year. KEYTRUDA is also approved in Europe as a monotherapy for the treatment of advanced melanoma in adults.
GLNG

Hot Stocks

06:17 EDT Golar LNG receives limited notice to proceed for FLNG vessel - Golar LNG announced that it has received a Limited Notice to Proceed from BP Mauritania Investments Ltd and BP Senegal Investments Ltd, in their capacity as block operators, in respect of the provision of a Floating Liquefaction Vessel to support the development of Phase 1 of the Greater Tortue / Ahmeyim field, located offshore Mauritania and Senegal. The LNTP is in furtherance of the Preliminary Agreement and Heads of Terms for a Charter Agreement with BP which was announced by Golar on April 19, 2018. The vessel conversion would take place at Keppel Shipyard Ltd building on Keppel's delivery of the FLNG Hilli Episeyo, utilizing Black and Veatch Corporation's PRICO technology. Discussions regarding a minority investment in the vessel are also being progressed.
ABB HTHIY

Hot Stocks

06:17 EDT ABB confirms plans to sell Power Grids unit to Hitachi - ABB (ABB) announces that Hitachi (HTHIY) will acquire ABB's Power Grids business, an expansion of its existing partnership with Hitachi. The agreed price represents a transaction Enterprise Value of $11B for 100% of Power Grids, the equivalent to an EV/op. EBITA multiple of 11.2x1, before share of corporate cost. ABB will initially realize a levered consideration of ~$9.1B from the sale of 80.1% of Power Grids, including pre-sale net leverage, before one-time transaction and separation related costs as well as cash tax impacts. In the fast-changing world of energy infrastructure, with a shifting customer landscape and the need for financing and increased government influence, ABB believes Hitachi is the best owner for Power Grids. ABB will initially retain a 19.9% equity stake in the joint venture, allowing a seamless transition. The transaction agreement includes a pre-defined option for ABB to exit the retained 19.9% share, exercisable three years after closing, at fair market value with floor price at 90% of agreed Enterprise Value. Hitachi holds a call option over the remaining 19.9% share at fair market value with floor price at 100% of agreed Enterprise Value. The joint venture will be headquartered in Switzerland, with Hitachi retaining the management team to ensure business continuity. ABB will record $350-400 million of stranded and other carve-out related costs, which are currently predominately recorded as part of the Power Grids cost base. ABB expects to incur one-time non-operational transaction and separation related costs of $500-600 million. ABB anticipates $800-900 million related cash tax impact. The completion of the transaction is expected by first half of 2020, subject to regulatory approvals and fulfillment of closing conditions. ABB intends to return 100 percent of the estimated net cash proceeds of $7.6-7.8 billion from the 80.1 percent sale to shareholders in an expeditious and efficient manner through share buyback or similar mechanism.
PNTR

Hot Stocks

06:15 EDT Pointer Telocation announces $8.5M 4G product delivery order - Pointer Telocation announced that it has received a large order for 4G product delivery from a telematics company valued at up to $8.5M. Product shipments are expected to start in Q2 of 2019 and to be completed in 2019.
ERJ BA

Hot Stocks

06:13 EDT Boeing to acquire 80% of new joint venture with Embraer for $4.2B - Embraer (ERJ) and Boeing (BA) have approved to the terms of a strategic partnership. The approved terms define the joint venture comprising the commercial aircraft and services operations of Embraer, in which Boeing will hold an 80% ownership stake and Embraer will hold the remaining 20%.The transaction remains subject to approval by the Government of Brazil, after which Embraer and Boeing intend to execute definitive transaction documents. The closing of the transaction will then be subject to shareholder and regulatory approvals and customary closing conditions. Under the terms of the proposed partnership, Boeing will acquire an 80% ownership stake in the joint venture for $4.2B. The partnership is expected to be neutral to Boeing's earnings per share in 2020 and accretive thereafter. Estimated annual pre-tax cost synergies of approximately $150M are anticipated by the third year of operations. Once the transaction has closed, the commercial aviation joint venture will be led by Brazil-based management, including a president and CEO. Boeing will have operational and management control of the new company, which will report directly to Dennis Muilenburg, Boeing chairman, president and CEO. Embraer will retain consent rights for certain strategic decisions, such as transfer of operations from Brazil. The companies have also agreed to the terms of another joint venture to promote and develop new markets for the multi-mission medium airlift KC-390. Under the terms of this proposed partnership, Embraer will own a 51% stake in the joint venture, with Boeing owning the remaining 49%. The transaction is subject to approval by the Government of Brazil, ratification by the Embraer board of directors and its further authorization to execute the definitive transaction documents. Once the parties have executed the definitive transaction agreements, the strategic partnership will then be subject to shareholder and regulatory approvals, as well as other customary closing conditions. Assuming the approvals are received in a timely manner, the transaction is intended to close by the end of 2019.
GOOG GOOGL

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06:08 EDT Google to spend $1B to establish new campus in New York - Google and Alphabet CFO Ruth Porat said in a blog post: "Today we're taking the next step in our commitment to our New York City presence by investing over $1 billion in capital improvements to establish a new campus, Google Hudson Square. The over 1.7 million square-foot campus is a result of lease agreements at 315 and 345 Hudson Street and a signed letter of intent at 550 Washington Street... With these most recent investments in Google Chelsea and Google Hudson Square, we will have the capacity to more than double the number of Googlers in New York over the next 10 years. Our investment in New York is a huge part of our commitment to grow and invest in U.S. facilities, offices and jobs. In fact, we're growing faster outside the Bay Area than within it, and this year opened new offices and data centers in locations like Detroit, Boulder, Los Angeles, Tennessee and Alabama. And as we continue to grow across the country, we look forward to calling New York City home for many years to come." Reference Link
BGNE

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06:07 EDT BeiGene initiates two global Phase 3 trials of tislelizumab - BeiGene announced that the first patients have been enrolled in two global Phase 3 clinical trials of its investigational anti-PD-1 antibody, tislelizumab. These trials are evaluating tislelizumab combined with chemotherapy as potential first-line treatments in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, and in patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.
ATHX

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06:05 EDT Athersys announces extension of HEALIOS K.K.'s exclusive period - Athersys announced the extension of HEALIOS K.K.'s exclusive period to negotiate an option that would allow Healios to obtain a license for the development and commercialization of MultiStem therapy for certain indications in China. Healios has agreed to make a one-time $2M payment in December 2018 for an extension through June 30, 2019. Furthermore, Healios may make an additional payment of $3M to extend the negotiation period for another six months through December 31, 2019. All such payments would be creditable against the $15M option fee that would be payable by Healios upon execution of the China option agreement, and milestones for any licensed program, if applicable.
EVFM

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06:05 EDT Evofem AMPOWER Phase 3 trial meets primary endpoint - Evofem announced that its Phase 3 clinical trial of Amphora for the prevention of pregnancy, AMPOWER, successfully met its primary endpoint. AMPOWER assessed the efficacy, safety and subject satisfaction with Amphora in approximately 1,400 healthy women aged 18-35 years at 112 centers in the U.S. The primary endpoint of the study was the pregnancy rate over seven cycles of use as assessed by the Kaplan-Meier statistical method. Top-line data analysis demonstrates a cumulative pregnancy rate of 14% over seven cycles of use. This corresponds to an 86.0% efficacy rate, which meets the pre-determined endpoint of this clinical trial. In women who correctly used Amphora per study protocol, the cumulative pregnancy rate was 1.3% over seven cycles of use. This corresponds to a 98.7% efficacy rate. The results demonstrate that when Amphora is used as directed, the efficacy in which women can have confidence is similar to other frequently used contraceptive methods. Overall in the AMPOWER study there were more than 24,000 acts of intercourse in which Amphora use was reported. Of these, Amphora was used as directed 88.9% of the time. There were minimal side effects reported by AMPOWER study participants, and there were no serious treatment-related adverse events reported. This outcome supports the potential of Amphora, Evofem's multipurpose vaginal pH regulator, to become the first non- hormonal, on-demand, woman-controlled prescription birth control vaginal gel.
OVID

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06:04 EDT Ovid Therapeutics: Phase 1b/2a trial of OV935/TAK-935 met primary endpoint - Ovid Therapeutics announced results from a 12-week, Phase 1b/2a clinical trial of OV935/TAK-935 that enrolled 18 adults with rare developmental and epileptic encephalopathies who were not successfully treated with available treatment regimens. The trial achieved its primary endpoint of safety and tolerability and showed OV935 was generally well tolerated. Exploratory analysis of OV935 showed reduction in seizure frequency that was correlated with decreases in plasma 24-hydroxycholesterol levels in adults across multiple DEE. OV935 is a potent, highly-selective first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase being investigated as a novel approach to treating epilepsy. Preclinical data suggest that inhibition of brain CH24H indirectly reduces glutamatergic signaling via NMDA receptors and modulates glial function and inflammation, which may impact disease pathology and epileptogenesis.
WYNN

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06:03 EDT Wynn Resorts says Maurice Wooden stepping down as Wynn Las Vegas president - Wynn Resorts Limited on Friday announced several changes to its senior executive team, including the return of Marilyn Spiegel as the President of Wynn Las Vegas. Spiegel previously served as president of the Las Vegas resort from 2010 to 2013. She will replace Maurice Wooden, who has elected to step down as the resort's president at year-end. Maurice Wooden, who has been President of Wynn Las Vegas since 2013, announced he was stepping down from his current position. In addition, the company has appointed Scott Moore as Chief Marketing Officer. Additionally, Michael Weaver, has been appointed Chief Communications Officer. Wynn Resorts has also recently made leadership changes to its Legal and Human Resources departments: Ellen Whittemore was recently named General Counsel of Wynn Resorts. Rose Huddleston recently joined Wynn Resorts as Senior Vice President of Human Resources, North America, a new position.
INSY

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06:01 EDT Insys Therapeutics provides update to strategic review process - INSYS Therapeutics provided an update on its product pipeline, which includes cannabidiol oral solution as well as epinephrine and naloxone nasal sprays. "Our strategic shift in focus away from opioids and to pharmaceutical-grade cannabinoids and novel drug delivery systems continues to gain momentum and has been driven by our strong commitment to advancing our diverse product pipeline," said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. "Through this intense focus on our reprioritized pipeline over the last year, which has been anchored by a patient-centric mission and commitment, we are radically transforming this company. As we look forward, we have the potential to submit six new drug applications over the next three years, two of which are scheduled for 2019." INSYS previously announced plans to begin a strategic alternative review of its opioid-related assets and the process remains on schedule. Nine companies have signed confidential disclosure agreements and have begun a review of confidential information materials. The company will provide an update on the process during the fourth quarter 2018 earnings call in early 2019.
SPI

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05:36 EDT SPI Energy receives delinquency notice from Nasdaq - SPI Energy announced that it received a notification letter Listing Qualifications Department of The Nasdaq Stock Market on December 12, 2018 indicating that the company is not in compliance with NASDAQ Listing Rule 5450(b)(3)(C) (the "Rule") for continued listing because the market value of its publicly held shares was less than $15 million. Normally, a company that fails to comply with the Rule would be eligible for a 180 day compliance period. However, in its November 19, 2018 decision, the Nasdaq Hearings Panel determined to impose a Panel Monitor lasting through 2019. The Panel noted that if at any time during the monitor period the company fails any listing standard, Nasdaq would issue a delisting determination and the hearings department would schedule a new hearing. Therefore, the company is not eligible for the 180 day compliance period and the Panel will notify the company of its newly scheduled hearing date in the coming days.
BDRBF

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05:35 EDT Bombardier to supply a further 20 FLEXITY trams to Karlsruhe - Global mobility solution provider Bombardier Transportation received a call-off order from Albtal-Verkehrs-Gesellschaft mbH, or AVG, the transport company of the Alb valley region in southwest Germany, for the delivery of 20 further dual-system BOMBARDIER FLEXITY trams. This third order is based on a framework agreement for a total of 75 vehicles from 2009. The order is valued at approximately $98M. The vehicles will be delivered between May 2020 and March 2021.
INCY

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05:27 EDT Incyte, Innovent announce strategic collaboration, licensing agreement - Incyte and Innovent Biologics announced that the companies, through their respective subsidiaries, have entered into a strategic collaboration agreement for three clinical-stage product candidates discovered and developed by Incyte-pemigatinib, itacitinib and parsaclisib. Under the terms of the agreement, Innovent will pay Incyte $40M in cash up front, and Incyte shall be eligible to receive an additional $20M in consideration in connection with the first investigational new drug application by Innovent in China, which is expected to be achieved in 2019. Innovent will receive the rights to develop and commercialize the three assets in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Per the terms of the collaboration agreement, Innovent will pay Incyte $40M in cash up front and Incyte will be eligible to receive an additional $20M in consideration in connection with the first IND filing in China, which is expected to be achieved in 2019. Innovent will receive rights to develop and commercialize three product candidates in hematology and oncology in the Innovent territory of Mainland China, Hong Kong, Macau and Taiwan. In addition, Incyte will be eligible to receive up to $129M in potential development and regulatory milestones, and up to $202.5M in potential commercial milestones. Incyte will also be eligible to receive tiered royalties from the high teens to the low twenties on future sales of products resulting from the collaboration. Incyte retains an option to assist in the promotion of the three product candidates in China. The transaction is effective immediately upon the execution of the strategic collaboration agreement. Further financial details were not disclosed.
RHHBY

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05:25 EDT Roche SMA treatment risdiplam granted PRIME designation by EMA - Roche announced that the European Medicines Agency has granted PRIME designation for the company's investigational oral medicine risdiplam for the treatment of people with SMA. PRIME designation is granted by the EMA to support data generation and development plans for promising medicines, providing a pathway for accelerated evaluation by the agency, and thus potentially enabling them to reach patients earlier. Risdiplam, an orally administered, survival motor neuron-2 gene splicing modifier, has shown improvements in motor function in people with SMA Types 1, 2 and 3. An increasing body of clinical evidence suggests that SMA is a multisystem disorder, and the loss of SMN protein may affect many tissues and cells beyond the central nervous system. Risdiplam is systemically distributed and designed to durably increase SMN protein levels in the central nervous system and throughout the body.