Stockwinners Market Radar for September 19, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:14 EDT Corporacion America Airport reports August passenger traffic up 1.6% y/y - Corporacion America Airport reports August total passenger traffic up 1.6% from last year, primarily reflecting growth of 9.0% in Argentina and 15.0% in Armenia, partially offset by declines in Brazil and Italy. Cargo volume increased 3.0% in August 2019, mainly as a result increases of 25.4% in Brazil and 19.1% in Italy, partially offset by declines of 7.4% and 13.0% in Ecuador and Armenia, respectively.

18:33 EDT First Financial to acquire The Bank & Trust of Bryan/College Station for $190M - First Financial has entered into a definitive agreement to acquire TB&T Bancshares and its wholly owned subsidiary, The Bank & Trust of Bryan/College Station, Texas. Subject to the terms and conditions of the definitive agreement, the acquisition consideration will consist solely of First Financial Bankshares common stock totaling approximately 6.276 million shares. The purchase price was established based on a $30.28 price per share of FFIN common stock and totaled $190M. Pending regulatory and shareholder approval, the acquisition is expected to be finalized in 1Q20. The acquisition of The Bank & Trust expands First Financial Bankshares' Texas footprint with five branches in Bryan and College Station, the home of Texas A&M University. As of June 30, The Bank & Trust had total assets of $624.5M, total loans of $445.6M and total deposits of $538.2M.

18:27 EDT Granite Construction awarded $22M development contract in California - Granite announced that it has been awarded a $22M contract by the MI San Luis Ranch LLC for the San Luis Ranch Development project in San Luis Obispo, California. Granite's scope of work includes earthwork, site grading, asphalt paving, underground utilities, storm drain retention basins, structural concrete, sidewalk, bicycle paths, traffic signals, and street lighting. The earthwork scope includes processing over 315,000 cubic yards of onsite material and importing approximately 325,000 cubic yards of new material to the project site. Construction is scheduled to begin in spring 2019 with an anticipated completion in fall 2020.

18:07 EDT AudioEye names Todd Bankofier as Chief Revenue Offfer - The board of AudioEye has appointed Todd Bankofier to the new position of Chief Revenue Officer. Bankofier ceases to serve as the company's CEO, effectively immediately. Executive Chairman Carr Bettis has assumed operating responsibilities and will continue to do so until a new CEO has been appointed.

17:58 EDT Boeing awarded $156.91M Air Force contract modification - Boeing has been awarded a $156.91M indefinite-delivery/indefinite-quantity bilateral contract modification to a previously awarded contract for the foreign military sales, or FMS, Royal Saudi Air Force F-15SA original equipment manufacturer training program. This modification adds a two year ordering period to the multi-year basic contract. This modification involves 100% foreign military sales to Saudi Arabia. Work is expected to be completed by December 31, 2021. Total cumulative face value of the contract is estimated and not to exceed $461M. Foreign military sales funds in the amount of $156.91M are being obligated at the time of award. The 338th Specialized Contracting Squadron is the contracting activity.

17:28 EDT Psychemedics enters new distribution agreement in Brazil - Psychemedics announced that it has entered into a new distribution agreement in Brazil with Sansao and with Toxicologia Pardini, its existing independent distributor in Brazil, formerly known as Psychemedics Brasil. The new agreement replaces the prior distribution agreement with Psychemedics Brasil. Psychemedics Brasil had a majority of its shares acquired by Instituto Hermes Pardini, or IHP, a provider of medical and diagnostic services in Brazil, including reference laboratory services. Under the new agreement, Sansao and Toxicologia Pardini were appointed as a non-exclusive distributor to sell, promote and distribute Psychemedics' hair drug testing services for an indefinite term. The agreement may be terminated for any reason by either party following 90 days' written notice. The distributor, IHP, and IHP's controlled companies are restricted to distributing only Psychemedics' hair drug tests and the hair drug tests of one other IHP company. The agreement provides for Psychemedics' hair drug tests to be marketed, sold and reported in Brazil under the Psychemedics brand name, with all related materials so identified. This agreement also allows Psychemedics to pursue other distribution opportunities in Brazil.

17:01 EDT Nordstrom names Kenneth Worzel as new COO - In a regulatory 8-K filing, Nordstrom announced that the company appointed Kenneth J. Worzel to the position of Chief Operating Officer. Mr. Worzel has served the company in various executive and leadership roles since 2010, most recently as Chief Digital Officer and President of Nordstrom.com.

16:55 EDT Arconic to sell forgings business in U.K. to Aero Forgings for roughly $62M - According to a regulatory filing, on September 13, 2019, Arconic reached an agreement to sell its forgings business in the United Kingdom to Aero Forgings Bidco Limited for approximately $62M in cash, subject to working capital and other adjustments. The transaction is expected to close in the fourth quarter of 2019, subject to regulatory approvals and customary closing conditions. As a result of the transaction, Arconic expects to recognize a restructuring-related charge of approximately $40M-$50M pre-tax in the third quarter of 2019, primarily related to the non-cash impairment of the net book value of the business. The sale is part of Arconic's announced intention to divest non-core businesses.

16:40 EDT Calyxt signs seed agreement with Landus Cooperative in Iowa - Calyxt has added Landus Cooperative's seed distribution, agronomy support, grain storage, and transportation services for Calyxt high oleic soybeans. This agreement expands the company's supply chain network into Iowa's 10 million acre soybean market, which is about 11% of total U.S. soybean production. The Landus Cooperative farmer-owners will be able to plant Calyxt's high oleic soybeans in the 2020 growing season. Landus Cooperative, a farmer-owned company in Iowa, has 30 agronomists partnering locally with growers to evaluate and recommend sustainable management programs to grow high-quality grain.

16:35 EDT First Solar transitions to leveraging third-party EPC services - First Solar, Inc. announced that it is transitioning away from its internal Engineering, Procurement and Construction execution model in the United States, and moving towards leveraging the capabilities of trusted EPC partners. The transition to leveraging third-party EPC services will occur through the rest of 2019 and will not impact any projects under construction and slated for delivery this year. First Solar is expanding its manufacturing capacity to meet the demand for Series 6 modules, with its second facility in the United States - representing nearly $1B in cumulative investment - expected to start production in early-2020. Once operational, the new facility in Perrysburg, Ohio, will take the company's aggregate Series 6 manufacturing capacity to 5.4GW per year, making First Solar America's largest solar manufacturer. The transition will impact approximately 100 associates who will be separated from the company at various stages of the process and will be provided with compensatory and outplacement support.

16:31 EDT ASA Limited reports NAV positive 59.4% for 9 months ended August 31 - ASA Gold and Precious Metals Limited reported that the total return for the nine months ended August 31, 2019, based on the company's net asset value, was positive 59.4%, including the reinvestment of distributions paid on the company's shares. On August 31, 2019, the NAV of the company was $16.08 per share versus $10.08 per share on August 31, 2018. For the nine months ended August 31, 2019, the total return based on the company's share price was positive 53.7%, including the reinvestment of distributions paid on the company's shares. The return for the FTSE Gold Mines Total Return Index during the same period was positive 60.0%. The closing price of the company's shares on the New York Stock Exchange on August 31, 2019 was $13.30, representing a share price discount to NAV of 17.3%. The share price of closed-end funds, such as the company, is determined by trading activity in the open market and consequently may reflect a premium or discount to its underlying NAV.

16:28 EDT Progressive's Chief Investment Officer William Cody retiring, succesor appointed - Progressive appointed Jonathan Bauer as its new Chief Investment Officer, effective January 3, 2020, following the retirement of William Cody. Cody will be retiring after 23 years at Progressive, including nearly 17 years as Chief Investment Officer. Jonathan Bauer joined Progressive Capital Management in 2006 and over the years has managed across a broad swath of Progressive's investment categories. Prior to Progressive, he spent 5 years with Bank of America in various fixed-income roles in Chicago and London.

16:26 EDT Nexstar completes accretive Tribune deal, sees 2019/2020 pro-forma FCF $1.02B - Nexstar Media Group (NXST) announced that it completed its previously announced acquisition of Tribune Media Company (TRCO) in an accretive transaction valued at approximately $7.2B including the assumption of Tribune Media's outstanding debt . Pursuant to the merger agreement, Nexstar acquired all outstanding shares of Tribune Media for $46.687397 per share in cash, inclusive of $0.187397 per share to reflect the final closing date relative to the August 31, targeted closing date. Nexstar also announced that upon closing the Tribune Transaction it completed the previously announced divestitures of 21 television stations for total consideration of approximately $1.33B. In addition, based on due diligence completed since the Tribune Transaction was announced, Nexstar now expects first year operating synergies of approximately $185M, an increase from its prior estimate of $160M. Reflecting the additional identified synergies, the favorable station divestiture process, terms for the financing of the Tribune Transaction, recent operating results and one-time revenue losses and expenses incurred in the 2019 third quarter related to distribution negotiations with AT&T, which resulted in an approximate $20 million annual impact to Nexstar's 2018/2019 and 2019/2020 free cash flow, Nexstar is reiterating its pro-forma average annual free cash flow guidance for the 2018/2019 cycle of approximately $900M and initiating pro-forma average annual free cash flow guidance for the 2019/2020 cycle of approximately $1.02B. Nexstar has approximately 46.1 million shares of Class A Common Stock outstanding.

16:21 EDT Scripps closes acquisition of TV stations divested from Nexstar-Tribune merger - The E.W. Scripps Company (SSP) has closed its acquisition of eight television stations in seven markets divested from the Nexstar Media Group, Inc. (NXST) transaction with Tribune Media (TRCO). The acquisition grows the Scripps local television station footprint to 60 stations in 42 markets, making it the nation's fourth-largest independent broadcaster with a reach of 31% of U.S. TV households. Since Jan. 1, Scripps has added 27 television stations to its portfolio, and it now expects 2020 company free cash flow to be in the range of $225M to $250M.

16:18 EDT S&P Dow Jones Indices unit CEO Alexander Matturri ot step down - S&P Global announced the retirement of Alexander Matturri, CEO of S&P Dow Jones Indices . Mr. Matturri is responsible for all of S&P DJI's business operations globally. Mr. Matturri will remain in his role as CEO of S&P DJI until next year to help ensure a smooth transition at the division. S&P Global will announce a replacement in due course.

16:16 EDT Align announces global distribution pact with Zimmer Biomet Dental - Align Technology, Inc. (ALGN) announced a global distribution agreement for the award-winning iTero Element family of intraoral scanners with Zimmer Biomet Dental, a division of Zimmer Biomet (ZBH). This agreement enables the company to leverage Zimmer Biomet Dental's extensive direct global salesforce and network of dental clinicians and laboratories to help drive further penetration of iTero scanners and services in the growing digital restorative market. The collaboration also offers Zimmer Biomet Dental customers access to Invisalign clear aligners through the iTero platform to facilitate a comprehensive interdisciplinary treatment approach. iTero Element scanners and services are now available through Zimmer Biomet Dental in select countries in Europe, with distribution expanding to the US, Canada and Japan starting in October 2019.

16:13 EDT Xilinx CFO Lorenzo Flores stepping down in October - Xilinx's CFO and Executive VP Lorenzo Flores is stepping down from his position to pursue another executive opportunity. Flores plans to leave Xilinx following the company's 2Q20 earnings on October 23, to ensure a smooth transition. The company has initiated a formal search for a new CFO. The company has appointed Sumeet Gagneja, Corporate VP, Finance and Corporate Controller, as Chief Accounting Officer and, Matt Poirier, Senior VP, Corporate Development and Investor Relations, will assume responsibilities of Treasurer. Gagneja and Poirier will report to Peng, who will provide oversight of finance operations while the company conducts its search for a new CFO.

16:10 EDT Western Asset Mortgage estimated book value per share $10.54 as of August 31 - The August 31 estimated book value is unaudited, has not been verified or reviewed by any third party and is subject to normal quarterly reconciliation and other procedures. Further, the estimated book value is as of August 31, and does not include the dividend announced on September 19.

16:08 EDT Ameris Bancorp raises quarterly dividend 50%, approves $100M stock buyback plan - Ameris Bancorp announced that its board of directors declared a quarterly dividend of 15c per share, reflecting an increase of 5c, or 50%, over the previous quarter's dividend. The dividend is payable on October 10 to shareholders of record on September 30. The board of directors also approved a new share repurchase program authorizing the company to repurchase up to $100M of its outstanding common stock. Repurchases of shares are authorized to occur through October 31, 2020. The program does not require the repurchase of any specific number of shares. It replaces the company's prior share repurchase program which was set to expire in October, and under which the company repurchased $10.6M of its outstanding common stock in the past year.

16:07 EDT Aware appoints Robert Eckel as CEO and President - Aware has appointed Robert Eckel as CEO and President. Eckel will also serve as a member of the Board of Directors of Aware. Current CEO and President, General Counsel Kevin Russell has been named Chief Legal and Administrative Officer. Russell will continue to serve as a member of the Board of Directors of Aware. Prior to joining Aware, Eckel served as the CEO and President North America for the Identity and Security business at Idemia.

16:05 EDT Western Digital to sell its IntelliFlash business to DDN, terms not stated - Western Digital announced that it has entered into a definitive agreement to sell its IntelliFlash business to DDN, a global leader in artificial intelligence and multi-cloud data management. In addition, Western Digital and DDN have agreed to expand their existing partnership through a multi-year strategic sourcing agreement, under which DDN will increase its purchase of Western Digital's HDD and SSD storage devices. This announcement is part of Western Digital's strategic intention to exit Storage Systems, which consists of the IntelliFlash and ActiveScale businesses. The company is exploring strategic options for ActiveScale. The transaction is expected to close later this calendar year, subject to the satisfaction of customary closing conditions. Financial terms of the transaction were not disclosed. Western Digital's intended exit of Storage Systems is expected to generate an annual non-GAAP EPS benefit of at least 20c starting in the Q3 of FY20. The company will also incur restructuring and other charges, which are not determinable at this time.

16:03 EDT Akamai acquires authentication technology from KryptCo - Akamai Technologies has acquired the technology of KryptCo, creator of multifactor authentication technology. KryptCo's CEO, Alex Grinman, has joined Akamai and will support Akamai's Zero Trust solution.

16:03 EDT FreightCar America announces manufacturing JV with Mexico's Fasemex for railcars - FreightCar America announced the formation of a joint venture with Fabricaciones y Servicios de Mexic, a Mexican company with operations in both Mexico and the United States, to manufacture railcars in Castanos, Mexico.When operational, FreightCar will have substantially repositioned its manufacturing footprint to include its state-of-the-art Muscle Shoals factory and the new factory in Castanos. The new factory is under construction and expected to start producing railcars in mid-2020. "Getting ourselves repositioned and on the right cost structure are core to our 'Back to Basics' strategy. We are making great progress in our material and fixed cost reduction efforts, and now, with the addition of this partnership in Castanos, we will become even more competitive in certain railcar types that weren't economically feasible previously," said Jim Meyer, President and Chief Executive Officer of FreightCar America. "While we complete construction of this new facility, we remain deeply committed to Shoals as our primary manufacturing platform and will continue with our plans to make incremental investments and consolidate our Roanoke operation into Shoals."

15:20 EDT California Resources slide attributed to Debtwire report - A late day selloff in shares of California Resources is being attributed to a report from Debtwire stating that the company is meeting with restructuring advisers, according to contacts. In late day trading, California Resources shares are down 26%.

14:32 EDT Cannae Holdings announces three-year, 5M share repurchase program - Cannae Holdings announced that its board of directors has authorized a three-year stock repurchase program, effective September 19, 2019, under which the company may repurchase up to 5M shares of its common stock. Purchases may be made from time to time in the open market at prevailing prices or in privately negotiated transactions through September 30, 2022.

13:34 EDT EnerSys reports fire at Richmond, Kentucky production facility - EnerSys reports that earlier a fire broke out in the battery formation area of its Richmond, Kentucky motive power production facility. The Richmond Fire Department and others responded quickly and the fire was extinguished. There were no reported injuries to employees or responders. The company said, "We would like to thank the Richmond Fire Department as well as any other fire companies, utility representatives or other first responders. While we are only in the early stage of assessment, we believe the fire will result in significant property damage and some amount of business interruption. Any business interruption will be felt mostly in the periods commencing after our second fiscal quarter, which ends on September 29, 2019. The Company maintains policies of insurance for both property damage and business interruption. We are assessing the potential for losses not covered by these policies and considering whether claims against other policies may be available to cover such losses. We are also assessing our ability to shift production to our other motive power facilities in North America, as well as transferring existing formation equipment to Richmond. We have contacted our vendor about new formation equipment."

13:23 EDT Pennsylvania REIT jumps over 8% after insiders purchase shares - Shares of Pennsylvania REIT are trading higher on Thursday after three company insiders revealed share purchases on Wednesday evening. Directors of the company Mark Pasquerilla, Leonard Korman and Charles Pizzi all purchased shares as reveled in filings. Korman bought 30,000 shares at $4.77 while Pasquerilla and Pizzi purchased 10,000 shares each at $5.46 and $5.34 respectively. Shares of Pennsylvania Real Estate Investment Trust are up 8.35% or 43c to $5.64 per share in afternoon trading.

13:10 EDT Newtyn Management discloses 8.8% stake in Merrimack Pharmaceuticals - Noah Levy's Newtyn Management disclosed an 8.8% stake in Merrimack Pharmaceuticals, which represents over 1.17M shares. The filing allows for activism. Newtyn purchased the shares based on its belief they were "undervalued and represented an attractive investment opportunity," according to the filing with the SEC. The stock was not bought for the purpose of acquiring control of Merrimack, added Newtyn. Eric Andersen's Western Standard today disclosed a 6.3% stake in Merrimack.

13:06 EDT Walgreens to test on-demand drone delivery service with Wing - Walgreens (WBA) and Wing, a member of the Alphabet (GOOGL) family of companies, are partnering on an industry first that will offer speed and convenience of "store to door" delivery of health and wellness, food and beverage and convenience items - via state-of-the-art drone technology - in minutes, the companies said in a statement. Walgreens, with a heritage of innovation in pharmacy and retail, and Wing Aviation LLC, the first drone operator certified as an air carrier by the Federal Aviation Administration earlier this year, will begin offering drone delivery service to eligible residents of Christiansburg, Virginia beginning next month. The companies will utilize the pilot program to further explore the future of health and wellness product and retail delivery through the air, offering product availability and home delivery minutes after placing orders via the Wing app. "Walgreens continues to explore partnerships to transform and modernize our customer experience and we are proud to be the first retailer in the U.S. to offer an on-demand commercial drone delivery option with Wing," said Vish Sankaran, chief innovation officer, Walgreens Boots Alliance, Inc. "With a customer-led focus, we continue to create differentiated shopping experiences that provide the products and services consumers need wherever, whenever and however they may want them. This is the kind of omni-channel partnership and offering that can redefine convenience for our customers and communities - delivering items to homes in minutes, not hours or days."

13:04 EDT Eros teams with Microsoft on 'next generation' online video platform - Earlier today, Eros (EROS) Now, a South Asian entertainment OTT video platform by Eros International announced a collaboration with Microsoft (MSFT) to build a next generation online video platform on Microsoft Azure targeted at its consumers across the globe. This is a unique association for Microsoft in India in the online video space. Eros Now will leverage Microsoft Azure for three areas of technology development: Intuitive Online Video Platform; Interactive Voice Offerings and Personalized Recommendation Engine. Commenting on the announcement, Rishika Lulla Singh, CEO- Eros Digital, said, "The Online Video market has brought a paradigm shift in the way technology is used and will be used to enhance the customer journey and user experience. We at Eros Now have been the earliest movers in the adoption of technology which is a core strength of the brand. The objective and the goal of this collaboration is to ensure we become the primary innovators for the video business and a gold standard for the others to follow. We have immense respect for Microsoft as a company to help us innovate and pave the path for the next generation of online video." Shares of Eros International are up 36% or 91c to $3.45 per share.

12:43 EDT GrubHub sinks after Jim Chanos announces short position - Shares of GrubHub (GRUB) are sinking after Jim Chanos, founder of Kynikos Associates, announced on CNBC that he's short the stock. GrubHub is making "almost no money" per order and its drivers outside of the major cities are making only $6-$7 per hour after expenses but don't realize it, the famed short-seller said. Further, GrubHub's take-rates are coming down, Chanos added. When asked if he's also short shares of Uber Technologies, whose Uber Eats competes with GrubHub, Chanos declined to answer but added that he's not positive on any company with a food delivery business. Shares of GrubHub are down 3.5% to $61.56 in midday trading while Uber is down 18c to $34.08. Chanos also discussed his yearslong short position in DaVita (DVA). The dialysis provider is down 3% to $59.34.

12:34 EDT Hawthorn Bancshares authorizes $5M for common stock repurchase program - Hawthorn Bancshares announced that the board authorized the purchase of up to $5.0M market value of Hawthorn Bancshares' common stock.

12:33 EDT CDC says vaping illnesses increase to 530 probable cases - The CDC said in a statement on its website: "There are 530 cases of lung injury reported from 38 states and 1 U.S. territory. Seven deaths have been confirmed in 6 states. CDC has received complete sex and age data on 373 of 530 cases. Nearly three fourths (72%) of cases are male Two thirds (67%) of cases are 18 to 34 years old. 16% of cases are under 18 years and 17% are 35 years or older. All reported cases have a history of e-cigarette product use or vaping. Based on initial data from certain states we know: Most patients have reported a history of using e-cigarette products containing THC. Many patients have reported using THC and nicotine. Some have reported the use of e-cigarette products containing only nicotine. We do not yet know the specific cause of these lung injuries. The investigation has not identified any specific e-cigarette or vaping product (devices, liquids, refill pods, and/or cartridges) or substance that is linked to all cases." Juul, in which Altria Group (MO) has a 35% stake, is the dominant e-cigarette maker in the U.S. Altria and Philip Morris (PM) are currently in merger talks. Reference Link

12:30 EDT Chanos says GrubHub making 'almost no money' per order - Jim Chanos, founder of Kynikos Associates, is speaking on CNBC.

12:28 EDT Chanos announces short position in GrubHub - Jim Chanos, founder of Kynikos Associates, is speaking on CNBC.

12:26 EDT Twitter's Head of Global Public Policy Colin Crowell to leave the company - Colin Crowell, a VP at Twitter and the Head of Global Public Policy and Philanthropy said via Twitter: "8 years-it's been an extraordinary journey. Today, I'm sharing that I've made the decision to leave Twitter. It's been a joy to work here and to build an extraordinary team of immensely talented people across the globe." Reference Link

12:23 EDT WestRock sees pre-tax impact from Hurricane Dorian of approx. $9M - WestRock Company provided an estimate of the impact of Hurricane Dorian on its fiscal fourth quarter financial results. The Company idled three of its containerboard mills in the southeastern United States that were located in areas of mandatory evacuation in the projected path of Hurricane Dorian. All three mills resumed production as the evacuation orders were lifted in their respective areas. The pre-tax impact from the hurricane on the Company's financial results for the quarter ending September 30, 2019 is expected to be approximately $9M. This impact is related to incremental costs to idle and restore the mills to operation, and the supply chain impacts of adapting our operations to meet our system requirements.

12:21 EDT New Media Investment jumps 9% to $9.47 after Cooperman mention on CNBC

12:10 EDT Cooperman says stock market can drop 25% if Elizabeth Warren wins - Leon Cooperman of Omega Advisors is speaking on CNBC.

12:07 EDT Apple Arcade launches on the App store - Apple said in a blog posting: "Apple has joined forces with some of the world's most visionary developers. Together, we're pushing the boundaries of what's possible to create the games of their dreams - and yours." The games being released include today include "Where Cards Fall,s; The Pathless , and and LEGO Brawls, among other. Reference Link

12:02 EDT Verizon says 5G network coming to NYC on September 26 - Verizon announced that, starting September 26, 2019, customers in parts of New York City will be able to access Verizon's 5G Ultra Wideband network, bringing the total number of U.S. cities with Verizon 5G mobility service to 11. The company said its plan is to launch 5G Ultra Wideband mobility service to more than 30 cities in 2019, focusing on dense, downtown areas and public spaces, and then rapidly expanding 5G availability. Reference Link

12:00 EDT VelocityShares 3x Long Natural Gas ETN falls -9.1% - VelocityShares 3x Long Natural Gas ETN is down -9.1%, or -$1.99 to $19.99.

12:00 EDT Global Ship Lease rises 13.5% - Global Ship Lease is up 13.5%, or 91c to $7.70.

12:00 EDT HDFC Bank rises 99.1% - HDFC Bank is up 99.1%, or $50.99 to $102.45.

11:42 EDT Sony announces State of Play livestream for September 24 with game reveals - The latest in Sony's line of PlayStation livestream events, State of Play, is coming September 24. Sony's Director, Social Media Sid Shuman noted the event in an earlier blog posting: "Hi all! Excited to share first details on PlayStation's next State of Play, which will air Tuesday, September 24 at 1:00pm Pacific Time / 4:00pm Eastern TIme. We're preparing a pretty hefty show, weighing in at around 20 minutes and sporting a fresh new look. And we'll have some great news to share with you, including new game reveals, new content from PlayStation's Worldwide Studios, and a host of other updates. Should be fun! Oh, and it probably bears mentioning: Don't expect any updates related to our next-gen plans in this episode. You can watch live on Twitch, YouTube (GOOG), Twitter (TWTR), and Facebook (FB), as usual. Can't wait to see what you think! And definitely keep that feedback coming - we read everything! Reference Link

11:37 EDT DaVita falls 1% after Jim Chanos discusses short position - Shares of DaVita fell after Jim Chanos, founder of Kynikos Associates, said at CNBC's Delivering Alpha conference that he's short the kidney dialysis company. Shares of DaVita are down 43c to $60.86 in late morning trading. Reference Link

11:33 EDT CHS Inc. renovating soybean processing plant to increase capacity - CHS Inc. announced plans for a significant renovation at its Fairmont, Minnesota, soybean processing plant. The expansion will increase market access for regional soybean growers and return value to its owners through increased production of high-demand soy-based food and feed ingredients. The operational and safety improvements will increase the Fairmont plant's soybean crush and soybean oil production capacity, enhance product quality and optimize production at the CHS soybean refinery at Mankato, Minnesota Construction is underway, and completion is expected by fall 2021.

11:28 EDT Antero Midstream evaluating wastewater treatment facility, landfill - In a filing, Antero Midstream said that it has commenced a strategic evaluation of its wastewater treatment facility and related landfill. While the company undertakes this evaluation, the Clearwater Facility and the Landfill will be idled, which is not expected to adversely impact the company's operating cash flow. "The net book value of the Clearwater Facility and the Landfill were approximately $300M and $75M, respectively, as of June 30, 2019. While the company anticipates it will be required to take an impairment charge relating to these assets, it is unable at this time to estimate the amount of any such impairment charge. The company expects to provide an update following the completion of its strategic evaluation when it makes a determination of an estimate or range of estimates for any such impairment charge," according to the filing.

11:24 EDT Santander Bank reduces prime rate to 5.0% - Santander Bank announced it has lowered its prime rate from 5.25% to 5.00%, effective September 18.

11:03 EDT Facebook brings video poll ads to mobile Feed - Facebook said in a statement, "To help brands further embrace this trend, today we are announcing new ad solutions that encourage a playful experience between people and businesses, and deliver results. Following the adoption of poll sticker for Instagram Stories ads that rolled out earlier this year, we are now bringing video poll ads to Facebook mobile Feed, globally available this month. In our early findings, we're seeing poll ads in Feed drive increased brand awareness and conversions. For example, in 5 out of 9 brand lift studies, we observed poll ads increased brand awareness compared to video ads." Reference Link

10:31 EDT Take-Two says Grand Theft Auto 5, Online has had 'terrific results' so far - At the Goldman Sachs Communacopia Conference, Take-Two said it expected Grand Theft Auto 5 and Grand Theft Auto online to moderate, but that for the first two quarters of the year, "we've had terrific results." However, the company expects Grand Theft Auto to moderate for the rest of the year, while the Rockstar online, including Red Dead Online, to be up year-over-year.

10:17 EDT ExlService CFO Vishal Chhibbar resigns to pursue new opportunity - In a regulatory filing earlier, ExlService disclosed that on September 14, Vishal Chhibbar, the company's Executive Vice President and Chief Financial Officer, provided notice to the company that he will be resigning to pursue an opportunity with a privately held company. Chhibbar's resignation will be effective as of December 13, 2019 during which time he will, among his regular duties, assist with any transition to his eventual successor. The company is conducting a search for a new CFO, it stated.

10:14 EDT Brainsway announces resignation of CEO Yaacov Michlin - BrainsWay announced Yaacov Michlin has resigned as CEO to pursue other business opportunities, and that the Company's Board of Directors intends to appoint a U.S.-based CEO as Michlin's successor. These changes follow the recent relocation of Hadar Levy, the Company's CFO, to the U.S., and his appointment to the additional role of COO. Until a new CEO is appointed, David Zacut, a co-founder of BrainsWay and its longtime Chairman of the Board, will serve as interim CEO.

10:06 EDT Wyndham Destinations' resorts to eliminate plastic straws, single-use plastic - Wyndham Destinations announced it would eliminate plastic straws and other single-use plastic from food and beverage operations at its timeshare resorts around the world. To support the company's environmental sustainability initiatives, Wyndham Destinations' vacation club resorts plan to remove single-use plastic straws starting Oct. 1, 2019. The effort will eliminate more than 750,000 single-use plastic straws in North America alone and 1.1M across the globe. Earlier this year, the company's Asia Pacific resorts removed disposable straws from 33 managed resorts. The company also announced it has developed a plan to eliminate plastic cups and lids, Styrofoam to-go boxes, plastic cutlery, and plastic to-go bags across the company's managed resort locations. This initiative will eliminate more than 4.8M single-use products by the end of 2020.

10:03 EDT Enterprise Products to expand, extend Acadian gas pipeline system - Enterprise Products Partners announced plans to expand and extend its Acadian natural gas system to deliver growing volumes of natural gas from the Haynesville Shale to the liquefied natural gas market in South Louisiana. The project will include construction of an approximately 80-mile pipeline originating near Cheneyville, Louisiana on Enterprise's Acadian Haynesville Extension to third party interconnects near Gillis, Louisiana, including multiple pipelines serving LNG export facilities in South Louisiana and southeast Texas. In aggregate, the LNG export market for this region includes design send out capacity currently operating or under construction of approximately 15 billion cubic feet per day. The Gillis Lateral will have a capacity of approximately 1 Bcf/d. As part of the project, Enterprise also plans to increase capacity on the Acadian Haynesville Extension by adding horsepower at its Mansfield compressor station in De Soto Parish. When completed, the expansion and extension project will increase the Acadian system's capability to transport Haynesville natural gas production from 1.8 Bcf/d to 2.1 Bcf/d. The project is supported by long-term customer contracts and is expected to begin service in mid-2021.

10:00 EDT Duke Energy to seek renewal of nuclear plant licenses in the Carolinas - Duke Energy announced it will seek to renew the operating licenses of the 11 reactors it operates at six nuclear stations in the Carolinas for an additional 20 years. The first Duke Energy nuclear power plants will approach the end of their current operating licenses in the early 2030s. Rigorous, ongoing preventive maintenance programs across the nuclear fleet and technology upgrades and investments over the years at all stations have contributed to their continuing strong operating performance. The company expects to submit the license renewal application for Oconee Nuclear Station in 2021, followed by its other nuclear stations. Oconee is the company's largest nuclear station, with three generating units that produce more than 2,500 megawatts.

10:00 EDT Foundation Building Materials falls -8.0% - Foundation Building Materials is down -8.0%, or -$1.51 to $17.43.

10:00 EDT Mogu rises 7.3% - Mogu is up 7.3%, or 21c to $3.09.

10:00 EDT HDFC Bank rises 100.7% - HDFC Bank is up 100.7%, or $51.81 to $103.27.

09:47 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares falls -5.2% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is down -5.2%, or -90c to $16.42.

09:47 EDT Linx S.A. rises 5.5% - Linx S.A. is up 5.5%, or 43c to $8.25.

09:47 EDT HDFC Bank rises 99.4% - HDFC Bank is up 99.4%, or $51.16 to $102.62.

09:28 EDT Aslan presents late-breaking data from Phase 2 study of Varlitinib in China - Aslan Pharmaceuticals announced late-breaking topline data from a phase 2 study conducted in China testing varlitinib and capecitabine in second line BTC patients. The data was presented during an oral session by Dr Weijia Fang, Associated Chief Physician, MD, Department of Medical Oncology, Zhejiang University, at the 2019 Chinese Society of Clinical Oncology meeting in Xiamen, China. The phase 2 study, which was closed before the completion of recruitment as previously announced, enrolled 62 patients in mainland China that had progressed on gemcitabine-based chemotherapy. The objective response rate in evaluable patients was 11%, including 2 patients with complete responses, the median progression free survival was 2.7 months and overall survival was 5.8 months. 45% of patients were alive at 6 months and 35% at 12 months. Overall survival data was based on 31 events and is still maturing. The varlitinib plus capecitabine combination was well tolerated in this difficult to treat patient population, the company said.

09:22 EDT GameStop announces 72-hour PRO DAY sale - Beginning Sept. 20-22, GameStop will be celebrating its third PRO DAY sale of the year where gamers can take advantage of more than $3,400 in exclusive deals.

09:17 EDT Virtusa joins Stanford Artificial Intelligence Laboratory as affiliate member - Virtusa Corporation announced it has joined the Stanford Artificial Intelligence Laboratory as an Affiliate Member. Virtusa's collaboration with SAIL will focus on using AI to help patients live longer, reduce food waste, and improve profitability of products in the healthcare, insurance, life sciences, communications, media, technology, and banking and financial services industries by extending open source research projects for AI. Other areas where Virtusa and SAIL will collaborate include reducing the shortcomings of Natural Language Processing with industry-specific solutions and using AI to advance solutions that rely on Big Data.

09:15 EDT Merrimack enters cooperation agreement with two funds, adds two board members - Merrimack announced that, effective immediately, its board has appointed Noah Levy, of Newtyn Management and Eric Andersen, of Western Standard to the board, pursuant to a cooperation agreement. Including Levy and Andersen, the Board will nominate five directors for election at the 2019 annual meeting of shareholders, which is scheduled for October 17. Levy's and Andersen's funds, Newtyn and Western, collectively represent approximately 15% of Merrimack shares outstanding, and Merrimack shares represented by all five Merrimack nominees now total approximately 23% of shares outstanding. Under the agreement Levy and Andersen have agreed to waive compensation for their board service. It also provides that the board will form a committee on strategy and expenses, chaired by Levy, that will focus on cost containment, continued NOL safeguarding and milestone payment and shareholder distribution maximization. As part of the cooperation agreement, both Newtyn and Western have agreed to vote for all five of Merrimack's nominees for election at the annual meeting. Newtyn's and Western's voting and other commitments under the cooperation agreement generally are evergreen with certain limited exceptions. Prior to reaching an agreement with Newtyn and Western, Merrimack also engaged with JFL and its advisors in an effort to reach a constructive solution that would prevent a contested election. During these discussions, JFL communicated to the board that its intended strategy was to use approximately $10M-$15M of the company's current cash reserves to purchase and develop a new small molecule in early stages of therapeutic development. Under JFL's plan the company would also explore the potential issuance of a preferred security entitling holders to the potential milestone payment, assuming this was possible from a tax perspective. These discussions with JFL were constructive and resulted in the company offering the fund two seats on the board and proposing the formation of a strategic committee that would be chaired by one of the JFL nominees. However, these discussions broke down over a few key issues, including the requirement by JFL that the strategic committee would have binding conditions placed on it preventing the committee from voting against an asset acquisition if they did not think it was in the best interest of the company and all shareholders.

09:10 EDT Capstone Turbine distributor signs FPP long-term service contract in California - Capstone Turbine announced that Cal Microturbine, Capstone's exclusive distributor for California, Idaho, Oregon, and Washington, has signed a Factory Protection Plan long-term service contract in California covering 2.0 megawatts of Capstone Microturbines installed at a single location for a major oil and gas company. "The continuing conversion of oil and gas customers to the Capstone Factory Protection Plan is driving our aftermarket business to new highs," stated Darren Jamison, Capstone's President and CEO. "With this latest contract, our FPP coverage is now 248 MWs, which is another new record for Capstone," added Jamison.

09:08 EDT Navistar to present 2020-24 strategy at 'Navistar 4.0' Investor Day event - Navistar will present the 2020-24 strategy, "Navistar 4.0," at its Investor Day event on 9/19, laying out a plan to increase the company's EBITDA margins to 12%. Navistar 4.0 includes the following elements: Improve EBITDA margins to 10% by 2022 and 12% by 2024; Grow market share and become the number one choice of the customer through new product offerings and customer segmentation; Implement a single platform strategy to optimize use of R&D resources and commonization of parts and tooling; Increase modular design resulting in customer benefits, speed to market and lower product costs; Build a new truck assembly facility in San Antonio, Texas, reducing logistics and manufacturing costs; Use the TRATON alliance to provide significant procurement savings, more efficient R&D spend and new integrated powertrain offerings for customers; Grow Aftersales revenues with an expanding distribution network, growing private label sales and e-commerce initiatives; Improve financial results allowing the company to invest in growth initiatives, de-lever the balance sheet and fully fund its defined benefit pension plans by 2025. Building on the major advances achieved in the last five years, including gains from an alliance with TRATON Group, Navistar 4.0 lays out a clear path for the company's ongoing transformation. "Navistar is committed to building on the gains of the past five years to improve financial returns to shareholders," said Troy Clarke, Navistar chairman, president and CEO. "Navistar 4.0 establishes a clear road map to grow EBITDA margins to 12%, while also winning in the marketplace."

09:06 EDT Fly Intel: Pre-market Movers - HIGHER: Microsoft (MSFT), up 1% after announcing a new $40B share repurchase program and 11% dividend increase... Beyond Meat (BYND), up 2% after being initiated with an Overweight at Barclays. DOWN AFTER EARNINGS: Darden (DRI), down 3%. ALSO LOWER: U.S. Steel (X), down 12% after its Q3 guidance missed analyst expectations... Provention Bio (PRVB), down 11% after its 5M share spot secondary priced at $8.00 per share... Ares Management (ARES), down 4% after its 7M share spot secondary priced at $29.90 per share... Overstock.com (OSTK), down 9% after recently departed CEO Patrick Byrne disclosed that he sold roughly 4.7M shares during the past three trading sessions, exiting his holding in the stock of the company he founded.

09:03 EDT Overstock.com down 9.3% in pre-market after founder Byrne sold 4.7M share stake - Shares of Overstock.com are down 9.3% or $1.50 at $14.69 per share in the pre-market. Yesterday evening, the company disclosed in a Form 4 filing that its founder Patrick Byrne sold a stake of 4.7M shares of common stock on September 16th-18th. The total transaction size in the sale was about $90M.

09:02 EDT Navistar to build new manufacturing facility in Texas - Navistar announced it will be making a capital investment of more than $250M to build a new manufacturing facility in the state of Texas. The investment, which is contingent on finalization of various incentive packages, will bring approximately 600 jobs to the San Antonio area. Navistar plans to break ground on the property later this year and anticipates production to begin approximately 24 months later.

08:59 EDT Hookipa Pharma to present data on TheraT technology at CICON Conference - HOOKIPA Pharma will present the anti-cancer impact of its TheraT technology in four poster presentations at the CICON Cancer Immunotherapy Conference. HOOKIPA's cancer immunotherapies are based on the flexible TheraT technology, which is a novel, replication-attenuated, arenavirus vector platform. TheraT is notable for targeting dendritic cells and inducing powerful cytotoxic T lymphocyte responses. TheraT immunotherapies have been shown to control tumors in preclinical models when targeted against various types of tumor associated/specific antigens and can be delivered intratumorally or systemically. The CICON posters highlight the robust preclinical data package and broad therapeutic utility for TheraT immunotherapies: TheraT directed against Human Papilloma Virus type 16 antigens was immunogenic, safe, and effective in clearing tumors and providing long-term protection in mouse models. Combination with checkpoint inhibitors potentiated TheraT's efficacy. TheraT was employed with two different arena viruses, in a so-called heterologous prime-boost approach, designed to drive even greater CTL response and thereby break tolerance. Intravenous administration of TheraT triggered up to 50% TAA epitope specific CTLs and established tumors were eliminated. A single dose of TheraT was shown to reprogram the tumor microenvironment and resulted in tumor eradication. Based on the preclinical data generated to date, HOOKIPA is planning to launch the first clinical trial of a TheraT immunotherapy in HPV16+ cancers in 2019.

08:48 EDT Neogen partners with IGS to enhance Igenity Beef Profile - Neogen has entered into a collaboration with International Genetic Solutions. The effort is focused on heightening genomic impact in the IGS platform, a multibreed beef genetic evaluation, and at the same time enhancing the research and development necessary to continue to improve Neogen's Igenity Beef Profile. The Igenity Beef Profile is a genetic testing product that helps producers of both purebred and crossbred beef cattle select their best animals for breeding programs.

08:39 EDT Generation NEXT to launch Reis & Irvy loyalty program, app during 2H20 - Generation Next summarized a list of company priorities which CEO Ryan Polk discussed in a letter to the Reis & Irvy's franchisees. The Company summarized its plans to build Reis & Irvy's into one of the most dominant soft-serve brands by 2021 through its unique location network, broad product offering, and data driven consumer marketing programs. Generation Next indicates it will also have a loyalty program and new Reis & Irvy's app launched during the second half of 2020. Earlier this year, Generation Next shared it was using data gathered from the initial round of installations to secure locations with the highest probability for higher soft-serve sales. The top six categories prioritized by the Company are airports, hospitals, hotels & resorts, large retail stores, museums, and travel centers. Agreements have been reached on a national level for airports, hospitals and large retailers. Conversations and pending agreements are in place with leading decision makers in the other categories. During July and August daily sales in these six categories were 107% higher than sales in the other location categories. As of September 13th, 2019 Reis and Irvy's kiosks have sold over 800,000 cups of frozen yogurt generating $4,000,000 in retail sales for franchise owners. YoCream and Generation Next are planning the introduction of soft serve ice cream in addition to frozen yogurt. Franchise owners of Reis & Irvy's unattended retail kiosks will have the option of serving these new products throughout 2020. The internal restructuring is complete and estimated to reduce annual operating expenses by a minimum of $3M. Progress is also being made on the nomination of a third independent Director for the Board. The Company repeated its intent to focus on the quality of kiosk operations by franchise owners including optimizing the site of each Reis & Irvy's installation and training on how to create and activate consumer awareness. East Asia and the Middle East are the two territories the Company is targeting for new Reis & Irvy's licensees. This initial global push is expected to generate commitments for 3,000 to 5,000 kiosks, worth between $100M and $200M of revenue with most deliveries occurring in 2021 and 2022 from an Asian manufacturing facility. A limited number of large-scale location agreements are being negotiated which would require Generation Next to own and operate the kiosks. If these agreements are executed, the deployment of company owned and operated kiosks into these locations would begin during 2020. A structure is also being considered that would allow franchise owners to partner with and take advantage of the corporate operations.

08:37 EDT Darden sees low single digit inflation for beef, produce, chicken in Q2 - For the second quarter, Darden says in comments taken from investor presentation slides that it sees low single digit inflation in beef, produce, dairy/oil, seafood, chicken, wheat and non-perishable.

08:33 EDT Manhattan Associates opens new India facility - Manhattan Associates announced that it has expanded and enhanced its Indian operations with the opening of a new facility in Brigade Tech Gardens. This investment increases Manhattan's footprint in India and reflects the company's strong commitment to the country. The new facility was inaugurated on September 18, 2019 in a dedication ceremony hosted by company executives. Over 1,400 Manhattan team members will be located in this new 170,000-square-foot facility.

08:31 EDT Global Ship Lease announces five-year $268M credit facility - Global Ship Lease announced that it has agreed a new syndicated $268M senior secured credit facility comprised of two tranches with major commercial lenders Credit Agricole Corporate and Investment Bank, ABN AMRO Bank N.V, CIT Bank NA, Hellenic Bank Public Company Limited and Siemens Financial Services Inc. The Company expects to draw down the first tranche of the New Senior Loan, in full, of $230M shortly and will use the proceeds to refinance five existing senior credit facilities with maturities in December 2020 and April 2021, thereby reducing its cost of debt, extending maturities, and simplifying its debt structure. As a result of the First Tranche Refinancing, three 2000-built 6,000 TEU ships will become unencumbered. The second tranche of up to $38M, or 65% of the market value of the vessel to be financed, is available, on similar terms, until May 2020 to facilitate further refinancing. The final maturity date of the New Senior Loan is expected to be September 2024, five years after drawdown. Borrowings under the New Senior Loan will bear interest at LIBOR plus a margin of 3.0%. Scheduled amortization is in line with fixed amortization which would have commenced March 2020 under the refinanced loans, at $5.2M per quarter. In addition, the Company has refinanced all of the existing indebtedness under its Junior Facility in the amount of $38.5M, with the only change being to extend its maturity from September 2023 to September 2024, consistent with the maturity date of the New Senior Loan.

08:23 EDT Verizon CEO says working on prices to get more people on unlimited plans

08:18 EDT Trovagene completes Phase 1b trial of onvansertib in Acute Myeloid Leukemia - Trovagene has completed its Phase 1b trial of onvansertib in combination with standard-of-care chemotherapy in acute myeloid leukemia - AML - and initiation of patient enrollment in Phase 2. The Phase 1b dose-escalation trial confirmed that onvansertib in combination with standard-of-care chemotherapy is safe and well tolerated. Additionally, the primary efficacy endpoint of objective response was achieved in 5 of 21 patients treated with onvansertib + decitabine, indicating anti-leukemic activity in this difficult-to-treat relapsed/refractory AML population. Importantly, 30% of patients treated were biomarker positive, which was associated with an increase in response to treatment as measured by decreases in bone marrow blasts and the rate of complete response. The Phase 2 AML trial will enroll 32 patients who are either treatment naive and not candidates for induction therapy or who have relapsed following up to one prior regimen.

08:16 EDT Momenta appoints Donna Grogan to board of directors - Momenta Pharmaceuticals announced the appointment of Donna Grogan, M.D. to its Board of Directors. Grogan recently stepped down as the CMO of Clementia Pharmaceuticals.

08:15 EDT Dynagas LNG enters into $675M senior secured term loan - Dynagas LNG announced that it has entered into definitive documentation with international banks for a syndicated $675M senior secured term loan. The Credit Facility will be secured by, among other things, first priority mortgages on the six LNG carriers in the Partnership's fleet. Borrowings under the Credit Facility, together with cash on hand, will be utilized to repay in full the Partnership's existing indebtedness, consisting of the Partnership's outstanding $470M Senior Secured Term Loan B upon closing of the Credit Facility and the $250M aggregate principal amount under the Partnership's 6.25% senior unsecured notes upon its maturity date of 30th of October 2019. The Credit Facility is repayable over five years in 20 consecutive quarterly payments based on a 14 year amortization profile and has a margin of LIBOR plus 300 basis points. The terms of the Credit Facility include financial covenants providing for the maintenance of maximum leverage ratios and minimum liquidity covenants, including the requirement for the Partnership to maintain a minimum cash balance of $50M throughout the life of the Credit Facility in a restricted collateral account. Under the terms of the Credit Facility, the Partnership will be restricted from paying distributions to its common unit-holders while borrowings are outstanding under the Credit Facility. Scheduled distributions to the preferred unit-holders under the existing Series A Preferred Units and Series B Preferred Units will not be restricted provided there is no event of default while the Credit Facility remains outstanding. The Partnership expects the financing to close before the end of September, subject to customary closing conditions.

08:13 EDT Foamix announces enrollment of first patient in Phase 2 trial of FCD105 - Foamix Pharmaceuticals announced that the first patient has been enrolled in its Phase 2 clinical trial to evaluate the efficacy and safety of its topical combination foam, comprised of minocycline 3% and adapalene 0.3%, FCD105 for the treatment of moderate-to-severe acne vulgaris. The Phase 2 clinical trial is expected to enroll approximately 400 patients, aged 12 years and older, with moderate-to-severe acne vulgaris. This prospective, randomized, double-blind, vehicle-controlled trial will be conducted at multiple sites throughout the United States. Patients will be randomized to one of four treatment arms: FCD105 foam, 0.3% adapalene foam, 3% minocycline foam or vehicle foam and will self-apply their assigned treatment once daily for 12 weeks. The study design follows current regulatory standards in evaluating the safety and efficacy of combination products of this type. The primary endpoints are: the proportion of patients achieving success at week 12 based on an Investigator's Global Assessment, the mean change from baseline in inflammatory lesion counts in each treatment group at week 12, and the mean change from baseline in non-inflammatory lesion counts in each treatment group at week 12. Safety evaluation will include reported adverse events, skin tolerability assessments, physical examinations and vital signs.

08:09 EDT Xeris Pharmaceuticals begins dosing in Phase 2 pramlintide with insulin study - Xeris Pharmaceuticals announced it began dosing patients in a Phase 2 clinical study to evaluate its investigational fixed-ratio co-formulation of pramlintide and insulin in patients with diabetes. Currently, pramlintide and insulin must be administered as two injections at separate sites before every meal. The company's XeriSol technology allows for simultaneous concentration and stabilization of insulin and pramlintide, which are incompatible in aqueous formulations. In addition to the effects of insulin, pramlintide enhances glucose control by slowing the absorption of carbohydrates in the body and serves to complement the body's interaction with insulin to regulate blood sugar levels.

08:07 EDT Avalon GloboCare initiates first-in-human clinical trial of AVA-001 in China - Avalon GloboCare announced it has initiated its first-in-human, Phase I clinical trial of CD19 Chimeric Antigen Receptor-T candidate, AVA-001, at the Hebei Yanda Lu Daopei Hospital and Beijing Lu Daopei Hospital in China. The clinical trial will interrogate the treatment of relapsed/refractory B-cell malignancies, including B-cell lymphoblastic leukemia and non-Hodgkin's Lymphoma. CAR-T cells are engineered to express a receptor that recognizes a specific cancer surface target to attack. Unlike traditional small molecule or biologic treatments, the autologous CAR-T therapies are specifically manufactured for each individual patient. AVA-001 was designed to provide a more powerful, personalized CAR delivery mechanism. Co-developed with China Immunotech Co. Ltd., AVA-001 is considered to be a second-generation CAR-T using the 4-1BB, a co-stimulatory signaling pathway, which exhibited strong anti-cancer activity during the pre-clinical study. It is also expected to feature a shorter bio-manufacturing time. The production process starts with the extraction of T cells from an individual patient, which are then converted into CAR-T cells that are specifically targeted to recognize and destroy cancer cells. The Company anticipates AVA-001 will entail a shortened bio-production cycle, which could potentially empower the clinicians to provide accelerated treatment to patients with hematologic malignancies. Avalon is expected to recruit 20 patients for clinical safety and efficacy monitoring and assessment.

08:04 EDT PDS Biotechnology to initiate three Phase 2 studies for PDS0101 starting in 1Q20 - Starting in the first quarter of 2020, PDS anticipates initiating three studies: A Phase 2 study to evaluate PDS0101 monotherapy in CIN2/3. A Phase 2 study in collaboration with Merck and Co. to evaluate PDS0101 in combination with KEYTRUDA in the treatment of HPV16-positive head and neck cancer. A Phase 2 study to evaluate PDS0101 in combination with two other novel clinically tested immunotherapies in advanced HPV-associated cancers to be conducted by the National Cancer Institute as a result of the NCI's independent preclinical testing of the combination. In addition, PDS is continuing to advance a pipeline of similar Versamune-based antigen-specific immunotherapies targeting prostate, colon, lung, breast and ovarian cancers and melanoma.

07:49 EDT Novo Nordisk says Tresiba showed overall lower risk of hypoglycaemia in CONCLUDE - New data from the CONCLUDE head-to-head trial show that Tresiba showed an overall lower risk of hypoglycaemia, also known as a hypo or low blood sugar, at a significantly lower HbA1c, compared with insulin glargine U300 in adults with type 2 diabetes uncontrolled on basal insulin with or without oral anti-diabetic drugs, reported Novo Nordisk. Results from the CONCLUDE trial were presented at the 55th Annual Meeting of the European Association for the Study of Diabetes. The primary endpoint, the rate of overall symptomatic hypoglycaemia in the maintenance period of 36 weeks which was tested for superiority, was numerically lower but not statistically significant versus insulin glargine U300, the company reported. The rate of overall symptomatic hypoglycaemia was statistically significantly lower in favor of Tresiba during the total treatment period of up to 88 weeks, Novo Nordisk said. "We are delighted that the findings of the CONCLUDE trial support what we have seen previously across the Tresiba clinical development program," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

07:38 EDT T2 Biosystems reports granting of inducement awards - T2 Biosystems announced that on September 9, 2019 it issued inducement awards to four new employees. These awards were made under T2 Biosystems' Inducement Award Plan, which was adopted by the company's Board of Directors on March 1, 2018 and amended and restated on February 21, 2019 and provides for the granting of equity awards to new employees of T2 Biosystems. The inducement awards consist of non-qualified stock options to purchase 26,000 shares of T2 Biosystems common stock and have a ten-year term. The exercise price of the options is $1.47, which was the per-share closing price of T2 Biosystems common stock on the Nasdaq Capital Market on September 9, 2019. The options vest over a four-year period, with 25% vesting on the first anniversary of the employee's date of hire and the remainder vesting in equal monthly installments over the three years thereafter. The award was approved by the independent compensation committee of T2 Biosystems' board of directors and was granted as an inducement material to the new employee entering into employment with T2 Biosystems in accordance with Nasdaq Marketplace Rule 5635(c)(4).

07:35 EDT Theratechnologies reaches agreement with ADAP for EGRIFTA SV - Theratechnologies announced that an agreement has been reached with the AIDS Drug Assistance Program Crisis Task Force for EGRIFTA SV, which will commercially launch in the United States very shortly. The agreement will help to facilitate access to low income, underinsured and uninsured Americans living with HIV in all 50 states and territories of the United States. EGRIFTA SV is a growth hormone-releasing factor. On November 5, 2018, the FDA approved EGRIFTA SV for the reduction of excess abdominal fat in HIV infected patients with lipodystrophy. Further to reaching an agreement for EGRIFTA SV, Theratechnologies and the task force also agreed to renew the contract for Trogarzo until December 31, 2021. Trogarzo was approved by the FDA on March 6, 2018. It represents a critical treatment advance for people living with persistent HIV. It is the first HIV therapy with a new mechanism of action approved in 10 years.

07:33 EDT Strongbridge says RECORLEV Phase 3 SONICS study meets primary endpoint - Strongbridge Biopharma announced that comprehensive results from the positive pivotal Phase 3 SONICS study of RECORLEV for the potential treatment of endogenous Cushing's syndrome were published online in The Lancet Diabetes & Endocrinology. SONICS enrolled 94 patients experiencing a mean urinary free cortisol of 6714 nmol/24 hours, which is nearly five times the upper normal limit. Seventy seven patients advanced into the six-month maintenance phase, and 61 patients completed this phase of the study. The SONICS study met its primary endpoint, with 30 percent of patients achieving mUFC normalization at the end of the maintenance phase among the intent-to-treat population, without a dose increase. The manuscript, entitled "Safety and efficacy of levoketoconazole in the treatment of endogenous Cushing's syndrome: A Phase 3, open-label, single-arm trial," includes mUFC responder analyses which found: For the patients who advanced into the maintenance phase, 81 percent had achieved mUFC normalization by the end of the dose titration phase. 36 percent of patients achieved normalization of mUFC during the maintenance phase, regardless of dose increase, ITT analysis. 46 percent of patients achieved a 50 percent or more decrease or normalization of mUFC during the maintenance phase, regardless of dose increase, ITT analysis. 62 percent of maintenance phase completers had normalized mUFC at month six based on 55 maintenance phase completers with both baseline and month six mUFC data available.For key secondary endpoints of cardiovascular risk biomarkers, such as fasting glucose, weight and LDL-cholesterol, RECORLEV demonstrated statistically significant and clinically meaningful mean improvements from baseline at the end of the maintenance phase. RECORLEV was generally well-tolerated during the dose titration and maintenance phases of the study and no unexpected safety signals were observed. The most common adverse effects were nausea and headache. Adverse events leading to discontinuation of treatment occurred in 12 of the 94 patients enrolled.

07:18 EDT CannTrust says Alberta products returned valued at approximately C$1.3M - CannTrust has received notice from the Alberta Gaming, Liquor and Cannabis Commission, the Crown corporation in charge of wholesale distribution of cannabis products to licensed cannabis retailers in Alberta, advising the company that the AGLC has determined that the company's products sold to the AGLC will be returned to the company pursuant to the terms of the Cannabis Supply Agreement between the company and the AGLC. Under the terms of the Supply Agreement, goods sold to the AGLC may be returned to the company for any reason and the company will be responsible for the cost of the goods and all expenses related to the return. The products to be returned constitute all or substantially all of the company's products currently held at the AGLC and are valued at approximately C$1.3M in the aggregate. The AGLC operates independently of Health Canada. Health Canada has not ordered a recall in respect of any of the company's products.

07:17 EDT Clearside Biomedical announces multiple presentations at retinal congresses - Clearside Biomedical announced that numerous presentations were given at three scientific congresses in Europe over the past two weeks. Clearside's Dr. Thomas Ciulla joined other academic and industry experts in the discussion of stem cells and gene therapy. The session reviewed novel endpoints, immune responses, and delivery methods for gene therapy, highlighting suprachoroidal administration and its potential for enhanced patient access to office-based gene therapy, as well as the potential for enhanced delivery to the retina. Suprachoroidal CLS-TA Improves Patient Outcomes in Uveitis of All Anatomic Subtypes: Results of the Phase 3 PEACHTREE Study: Dr. Ron Neumann presented an electronic poster for the event reviewing the results of Clearside's Phase 3, PEACHTREE study for XIPERE, formerly known as CLS-TA. The PEACHTREE study was the first pivotal trial specifically studying macular edema due to non-infectious uveitis and the first uveitis trial with a primary endpoint of visual acuity, a significant and clinically meaningful outcome for both physicians and patients. The 96 patients treated with suprachoroidally injected CLS-TA had been diagnosed with non-infectious uveitis involving any anatomic location, reflective of clinical practice. The primary endpoint of the trial was met with nearly 1 of 2 patients experiencing a 3-line visual gain, and 1 of 2 patients experiencing resolution of macular edema. The results were consistent regardless of the anatomical location of the uveitis. There were no serious adverse events attributable to CLS-TA, and there were low rates of elevated intraocular pressure. Cataract adverse events were similar between treatment and control groups and the vast majority of CLS-TA patients did not need rescue therapy. Suprachoroidal Triamcinolone Acetonide Suspension and Intraocular Pressure: Results from the Phase 3 PEACHTREE Clinical Trial for Uveitis: Dr. Pauline Merrill gave an extensive presentation on the results of PEACHTREE with a focus on intraocular pressure. With respect to IOP-related adverse events, the rate was 12% in the suprachoroidal CLS-TA treatment group compared to 16% in the control group. Rescue medications were required in 72% of the patients in the control group. Ten patients in the control group experienced IOP-related AEs and each received intravitreal steroids as their rescue therapy. There were no glaucoma surgeries in either group. Further analysis found that IOP greater than or equal to 30mmHg was observed in 5% of CLS-TA treated eyes compared to 11% of the control eyes which received rescue treatment. Similarly, IOP lowering medications were used in fewer eyes treated with suprachoroidal triamcinolone acetonide compared to the control eyes receiving rescue treatment.

07:11 EDT Darden CEO says 'pleased' with Q1 results - "I'm pleased with our results this quarter as we continued to gain market share," said CEO Gene Lee. "Our teams remained focused on improving the guest experience by focusing on our back-to-basics operating philosophy and leveraging our competitive advantages, all while managing costs effectively."

07:09 EDT Sunesis appoints Nicole Onetto to board of directors - Sunesis Pharmaceuticals announced that Dr. Nicole Onetto, M.D. has been appointed to the Sunesis Board of Directors. She was most recently deputy director and CSO at the Ontario Institute for Cancer Research from 2009 to 2016.

07:07 EDT Darden reports Q1 blended same-restaurant sales up 0.9% - Q1 same-restaurant sales by brand: +2.2% for Olive Garden; -5.4% for Cheddar's Scratch Kitchen; +2.6% for LongHorn Steakhouse; -1.9% for Yard House; +1.5% for The Capital Grille; -4.2% for Seasons 52; +1.2% for Eddie V's; -4.2% for Bahama Breeze.

07:06 EDT Valeritas to present preclinical h-Patch CBD study at CannMed Conference - Valeritas Holdings announced data from its preclinical pharmacokinetic study of cannabidiol subcutaneous infusion delivered via its h-Patch wearable drug delivery device have been accepted for a poster presentation at the annual CannMed Conference in Pasadena, CA, on September 23-24, 2019. Pharmacokinetic Study of Subcutaneous Infusion of Cannabinoid Isolate in Dogs via the h-Patch Wearable Device: On July 30th, Valeritas announced positive results from a preclinical pharmacokinetic study of cannabidiol subcutaneous infusion with two dosing regimens delivered via its proprietary h-Patch wearable drug delivery device. The company believes this study represents the first report of CBD delivered via subcutaneous infusion in any preclinical model. Valeritas' h-Patch is a drug delivery technology that can facilitate the simple and effective subcutaneous delivery of injectable medicines to patients across a broad range of therapeutic areas. The company's V-Go is the first FDA-approved product that utilizes the h-Patch technology. To date, more than 20 million V-Go insulin delivery devices have been sold in the United States. Oral CBD solutions have very low bioavailability in humans, in the range of 6-10%, and concerns linger over their long-term effect on the liver as a result of exposure to toxic metabolites. The h-Patch system provides a continuous basal delivery rate over a period of 24 hours and maximizes the therapeutic result by avoiding the first-pass effect and eliminating peak/trough variations of drug exposure. Subcutaneous infusion of CBD via the h-Patch may offer several distinct advantages over oral dosing including the ability to achieve therapeutic drug concentrations with a fraction of the overall dose, significantly prolonged half-life, minimization of the variation in CBD metabolism in the general population, and a dramatic reduction in the overall amount of drug metabolized by the liver. These features may contribute to a dramatically improved risk-reward profile for a CBD isolate therapeutic and could open the door to reliable, uniform dosing.

07:04 EDT Darden backs FY20 CapEx view $450M-$500M - Backs FY20: Approximately 50 gross and 44 net new restaurant openings; Total inflation of approximately 2.5%; Effective tax rate of 10%-11%.

07:03 EDT Wells Fargo enters data exchange agreement with Plaid - Wells Fargo announced it has entered into a data exchange agreement with Plaid. As a result, Wells Fargo customers will be able to share their financial data with the digital financial tools and services Plaid supports using an application-programming interface, or API. Many Wells Fargo customers access their financial data through Plaid to use apps that help them. With this agreement, Wells Fargo customers will have control over the bank account information they share with Plaid-supported apps, including the ability to turn on or off data sharing through Wells Fargo's control tower digital experience. Control tower helps consumer and small business customers manage their online financial lives by providing a single view of their Wells Fargo digital financial footprint. Wells Fargo will launch the experience with select Plaid customers within a year.

07:03 EDT Anixa Biosciences collaborating with Potomac Urology Center on prostate cancer - Anixa Biosciences announced that Potomac Urology Center has joined its Cchek early cancer detection study. PUC will provide patient samples for Anixa's ongoing prostate cancer study, including support of clinical validation of Anixa's Cchek Prostate Cancer Confirmation test. PUC is a urology practice throughout the Northern Virginia area in the diagnosis and treatment of urology related conditions.

07:02 EDT Izea appoints Justin Andrews as CFO - IZEA Worldwide announced the appointment of Justin Andrews, CPA as CFO, effective September 17, 2019. Andrews will serve on the IZEA Executive Leadership Team and will report directly to Ted Murphy, CEO of IZEA Worldwide. Andrews previously served as VP of Finance, acting as the division CFO for multiple portfolios of ESW Capital.

07:00 EDT Cousins Properties signs lease expansion with Amazon at Domain 10 in Austin - Cousins Properties (CUZ) announced that it has signed a lease expansion with Amazon (AMZN) for an additional 104,000 square feet at Domain 10 in Austin. This transaction expands Amazon's lease to 249,000 square feet at the 300,000 square foot development. Domain 10 is now 98% leased and is anticipated to deliver in Q3 of 2020.

06:33 EDT Aerie Pharmaceuticals submits prior approval supplement for Rocklatan to FDA - Aerie Pharmaceuticals has submitted a prior approval supplement to the FDA. If approved, the PAS will permit production of Rocklatan ophthalmic solution 0.02%/0.005% for sale in the U.S. in Aerie's new manufacturing plant in Athlone, Ireland. Based on FDA timelines, Aerie expects the PAS filing review to be completed within 60 days, with final PAS review in 4 months. In addition, the company anticipates a preapproval inspection of the Athlone manufacturing plant during the 4-month review. A successful inspection along with FDA approval of the supplement would allow Rocklatan to be manufactured in Athlone for sale in the U.S. in the first half of 2020. The company also plans to file a PAS in the first half of 2020 to obtain FDA approval to manufacture Rhopressa ophthalmic solution 0.02% in Athlone. Rocklatan was approved by the FDA in the U.S: on March 12 and the commercial launch in the United States occurred on May 1.

06:30 EDT Target announces new $5B share repurchase program

05:27 EDT Applied DNA Sciences, Takis/Evvivax vaccine candidates showed tumor reduction - Applied DNA Sciences announced that LineaRx, its majority-owned subsidiary, and its collaborators Takis/Evvivax have completed pre-clinical animal studies of two vaccine candidates produced with linear DNA. Tests of both vaccines in mouse models demonstrated their ability to eliminate tumors in vivo, and to potentially prevent initial occurrence. Evvivax S.R.L. designed a synthetic gene sequence to produce immunity in companion animals, directed against the protein telomerase, or TERT, which is overexpressed in 85% of all mammalian cancers, whereas Takis S.R.L. designed a neoantigen-based cancer vaccine, or TK, as a proof-of-concept of personalized immunology. For the studies, the TERT and TK based vaccines were produced in linear DNA form by LineaRx. Here is a summary of the recently completed studies performed in vivo: Previous results from Phase 1 of the collaboration's Joint Development Agreement, or JDA, confirmed immunogenicity in mice that were vaccinated with linear DNA against the human protein telomerase. The results reported herein are from the Phase 2 of the JDA using mice implanted with murine colon cancer. In the prophylactic use of the telomerase vaccine, wherein vaccination is done before addition of tumor cell lines to the mice, transplanted tumors were cleared within 10 days. In the therapeutic application using either TERT or TK linear DNA vaccine application, cancer cells were introduced and allowed to grow before administration of the vaccine. The successful reduction of total tumor mass was accomplished in conjunction with antibodies that targeted PD-1 and CTLA4. These antibodies, known as Checkpoint Inhibitors, are commonly used in oncology strategies that rely upon immunotherapy. In this setting the tumor cells were reduced significantly within 30 days. The strategy of the Takis TK neoantigen vaccine uses unique multiple-target antigenic epitopes that have been identified from the tumor of a human patient. The linear DNA can utilize the genes for several of the most effective universal antigens such as TERT, or neoantigens that are more personalized to the patient.