Stockwinners Market Radar for October 30, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:12 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: Accuray (ARAY) up 14.8%... Exact Sciences (EXAS) up 8.7%... Habit Restaurants (HABT) up 8.5%... FireEye (FEYE) up 6.2%... Ternium (TX) up 4.7%... QuinStreet (QNST) up 4.4%... Yum China (YUMC) up 4.1%... Whiting Petroleum (WLL) up 4.0%... BJ's Restaurants (BJRI) up 3.9%... CAI International (CAI) up 3.5%... Facebook (FB) up 3.5%... Zendesk (ZEN) up 3.2%... Concho Resources (CXO) up 1.7%... Herbalife (HLF) up 1.6%... MGM Resorts (MGM) up 1.2%... Genworth Financial (GNW) up 1.2%. DOWN AFTER EARNINGS: 3D Systems (DDD) down 21.0%... McDermott (MDR) down 20.0%... Clovis Oncology (CLVS) down 19.9%... Container Store (TCS) down 18.9%... TTM Technologies (TTMI) down 10.9%... Big 5 Sporting Goods (BGFV) down 10.4%... Shutterfly (SFLY) down 10.0%... Nanometrics (NANO) down 8.9%... Paycom (PAYC) down 7.8%... Nutrisystem (NTRI) down 7.7%... SunPower (SPWR) down 5.1%... Electronic Arts (EA) down 4.6%... NuVasive (NUVA) down 4.1%... Energous Corporation (WATT) down 3.1%... Ultimate Software Group (ULTI) down 2.5%... Maxim Integrated Products (MXIM) down 1.6%... T-Mobile (TMUS) down 0.8%... eBay (EBAY) down 0.6%... Baidu (BIDU) down 0.5%. Afterhours prices as of 18:45 ET.

18:55 EDT Mitsubishi UFJ to acquire CFSGAM for JPY328B - Mitsubishi UFJ Trust and Banking, a consolidated subsidiary of MUFG, announced that it has entered into a conditional Share Sale Deed with Australian financial group Commonwealth Bank of Australia and its wholly-owned subsidiary Colonial First State Group Limited, to acquire 100% of the shares in nine subsidiaries of Colonial First State Group Limited, which collectively, including their subsidiaries, represent the global asset management business of Colonial First State Global Asset Management, from the Sellers. Subject to the satisfaction of conditions precedent set out in the Share Sale Deed, the Trust Bank will acquire 100% of CFSGAM for total cash proceeds of approximately JPY328B. The Proposed Transaction is expected to close in mid-2019.

18:13 EDT S&P announces changes to S&P 400, 500, 600 indices - S&P Dow Jones Indices will make the following changes to the S&P 500, S&P MidCap 400 and S&P SmallCap 600: S&P MidCap 400 constituent Keysight Technologies (KEYS) will replace CA (CA) in the S&P 500, S&P SmallCap 600 constituent Ligand Pharmaceuticals (LGND) will replace Keysight Technologies in the S&P MidCap 400, and Marcus & Millichap (MMI) will replace Ligand Pharmaceuticals in the S&P SmallCap 600 prior to the open of trading on Tuesday, November 6. S&P 500 constituent Broadcom (AVGO) is acquiring CA in a deal expected to close on or about that date pending final conditions. Arcosa (ACA) will replace KapStone Paper and Packaging (KS) in the S&P SmallCap 600 effective prior to the open of trading on Monday, November 5. S&P MidCap 400 constituent Trinity Industries (TRN) is spinning off Arcosa to shareholders in a deal expected to be completed on November 1. Post spin-off, Trinity Industries will remain in the S&P MidCap 400. S&P 500 constituent WestRock (WRK) is acquiring Kapstone Paper and Packaging in a deal expected to close on or about November 2 pending final conditions.

18:00 EDT Facebook says a lot of growth is coming from Asian market - Says passive consumption of video can displace social infractions. Says starting to work through formula to take rate limits off video. Says long-term monetization depends on the effectiveness of ads. Says there was a three-year roadmap to get security systems to where the company wanted them to be starting in 2016. Says it expects security to be dialed in by the end of the next year. Says it is investing in capacity ahead of user growth.

17:41 EDT First Northwest Bancorp initiates 3c quarterly dividend - The dividend will be paid on December 14, 2018, to shareholders of record on November 30, 2018.

17:32 EDT Boeing awarded $244.71M Naval Air Systems contract - Boeing was awarded a $244.71M not-to-exceed, firm-fixed-price contract to procure long lead material for Harpoon full-rate production lot 91 in support of multiple foreign military sales, or FMS, customers. Work will be performed in Missouri, Texas Ohio, Burnley, United Kingdom, Connecticut, Oklahoma, Maryland, Pennsylvania, Kansas, Alabama and various locations within the continental U.S and is expected to be completed in March 2023. FMS funds in the amount of $244.71M will be obligated at time of award, none of which will expire at the end of the current fiscal year. This contract was not competitively procured. The Naval Air Systems Command is the contracting activity.

17:26 EDT EA 'confident' that 'FIFA 19' players will get into 'Ultimate Team' - EA (EA) says it's "confident" that "FIFA 19" players will gradually get into "FIFA Ultimate Team." Says had one of the strongest "Ultimate Team" weekends recently despite attention given to Take-Two's (TTWO) "Red Dead Redemption 2." Says "very excited" about subsidiary BioWare's upcoming game "Anthem."

17:24 EDT Arcosa to replace KapStone in S&P 600 at open on 11/5 - Trinity Industries (TRN) is spinning off Arcosa (ACA) to shareholders in a deal expected to be completed on November 1. Post spin-off, Trinity Industries will remain in the S&P MidCap 400. WestRock (WRK) is acquiring Kapstone Paper and Packaging (KS) in a deal expected to close on or about November 2 pending final conditions.

17:21 EDT eBay reports Q3 operating margin 26.4% vs.28.4% last year

17:20 EDT Marcus & Millichap to replace Ligand in S&P 600 at open on 11/6

17:19 EDT EA sees FY19 live services net bookings flat to up 5% - Says 29% of "FIFA 19" sales were digital. Says larger percentage of unit sales were digital in the quarter compared to the same quarter last year. Sees FY19 live services net bookings flat to up 5% year-over-year. Sees net bookings from full game downloads up 20%-25% in FY19.

17:18 EDT Sanofi announces FDA priority review granted for dengue vaccine - The FDA has accepted a biologics license application for Sanofi Pasteur's dengue vaccine. The dengue vaccine candidate has been granted priority review by the FDA as it would represent the first and only medical prevention tool against dengue, including severe dengue, which is considered an unmet medical need. The FDA set a Prescription Drug User Fee Act action date of May 1. Dengue is endemic in the U.S. territories of Puerto Rico and the US Virgin Islands. In 2010, Puerto Rico experienced the largest outbreak when more than 12,000 cases were confirmed. Incidence remained high in subsequent years, particularly in 2012 and 2013. Dengue represents a health and economic burden in Puerto Rico with total annual associated costs reaching an estimated $160.2M. The vaccine, known as Dengvaxia in countries where it is approved, remains the only vaccine available for the prevention of dengue. The European Commission is expected to grant marketing authorization for Dengvaxia in December.

17:18 EDT Keysight Technologies to replace CA Technologies in S&P 500 at open on 11/6 - S&P 500 constituent Broadcom (AVGO) is acquiring CA (CA) in a deal expected to close on or about that date pending final conditions

17:14 EDT Cheesecake Factory sees FY19 food inflation of 1%-2%

17:11 EDT EA says new game from Respawn set to come out next Holiday season

17:09 EDT Amgen reports Q3 product sales up 1% globally

17:08 EDT EA says 'FIFA 19' acclaimed as one of the best in the franchise - Says "FIFA 19" aimed to expand "FIFA" offerings through additional content. Says "FIFA 19" acclaimed as one of the best games of the franchise. Says "Madden NFL 19" has "most-immersive" NFL experience company has ever delivered. Says "Battlefield V" built from ground up as live service product. Comments taken from Q2 earnings conference call.

17:05 EDT RenaissanceRe to acquire Tokio Millennium Re for $1.5B - RenaissanceRe Holdings announced that it has entered into a definitive agreement with Tokio Marine Holdings pursuant to which an affiliate of RenaissanceRe will acquire Tokio Marine's reinsurance platform, which includes Tokio Millennium Re AG and Tokio Millennium Re (UK) Limited. Under the terms of the transaction, Tokio Marine will receive 1.02x the tangible book value of TMR delivered to RenaissanceRe at closing. If closing tangible book value is unchanged from June 30, Tokio Marine would receive approximately $1.5B in total consideration, consisting of cash and RenaissanceRe common shares. RenaissanceRe expects that upon closing the transaction will be immediately accretive to book value per share, tangible book value per share, operating earnings per share and operating return on equity. The agreement has been unanimously approved by the boards of both companies. The transaction is expected to close in the first half of 2019 and is subject to customary closing conditions and regulatory approvals. No shareholder approval is required. Under the terms of the agreement, if closing tangible book value is unchanged from June 30, 2018, the transaction consideration would consist of approximately $1.22B of cash and $250M of RenaissanceRe common shares. The cash consideration will be funded through RenaissanceRe available funds and a potential pre-closing dividend from TMR, subject to regulatory approval.

17:03 EDT Benchmark Electronics expands stock repurchase program by $100M - Benchmark Electronics announced that its Board of Directors has granted the company authority to repurchase an additional $100M in common stock. Previously, on March 7, 2018, the Board had expanded an existing share repurchase program by $250M. Net of shares repurchased to date, the total remaining authorization outstanding is approximately $262M.

16:56 EDT Yum China up 7% to $33.91 after Q3 results

16:55 EDT McDermott sees second half of FY18 revenue $4.8B-$5.1B - Sees EPS of (11c) to (6c). Sees operating margin of 4.2%-4.5%. Sees EBITDA of $375M-$415M.

16:52 EDT Yum China declares quarterly dividend of 12c per share - Payable as of the close of business on December 18 to stockholders of record as of the close of business on November 27.

16:49 EDT B&G Foods reports Q3 adjusted EBITDA $91.9M, down 2.3% from last year

16:47 EDT Qualys announces additional $100M share rpurchase progam

16:44 EDT Apollo Investment board approves 1-for-3 reverse stock split

16:41 EDT Keurig Dr Pepper, DWA sign long-term distribution agreement for evian - Keurig Dr Pepper and Danone Waters of America jointly announced that KDP will sell, distribute and merchandise evian across the U.S., as part of a long-term master distribution agreement designed to accelerate the brand's growth. The agreement will bring the world's leading brand of premium natural spring water to more Americans through KDP's extensive distribution networks covering the U.S., with sales capabilities that include national and regional accounts, frontline sales teams and in-store execution. This partnership includes coverage of grocery, mass, club, convenience, drug and independent stores, as well as e-commerce.

16:39 EDT Baidu CEO says 'delivered a solid third quarter' - "Baidu delivered a solid third quarter with impressive results from search, feed and new AI businesses. Feed revenue has been a bright spot in driving Baidu's revenue growth due to robust user traffic growth, as well as strong traction with Baidu's video offerings," said Robin Li, Chairman and CEO of Baidu. "On the AI side, DuerOS continues to see strong adoption with an installed base reaching 141 million and voice queries surpassing 800 million in September 2018. On Apollo, we are gaining valuable L4 operational experience, with fully autonomous Apolong minibuses powered by Apollo running in over 10 locations." "Baidu's third quarter revenues were strong, growing 27% year over year to RMB 28.2 billion. Net income attributable to Baidu grew 56% year over year to RMB 12.4 billion, while non-GAAP net income attributable to Baidu grew 47% year over year to RMB 6.7 billion," said Herman Yu, CFO of Baidu. "We are seeing strong traffic and revenue growth from feed in Baidu App and replicating this formula to develop other feed apps, such as Haokan, our short-video app."

16:35 EDT Hyatt announces new $750M stock buyback program - CEO Mark Hoplamazian says: "We are continuing to execute our long-term growth strategy while returning meaningful capital to shareholders, enabled in part by our sell-down of real estate. Earlier this month, we announced plans to acquire Two Roads Hospitality, a high-end lifestyle hotel management company which we expect will expand the growth of our management and franchising business. We also increased our shareholder capital return expectations for 2018 to approximately $1.0 billion inclusive of share repurchases and dividends, and have a new $750 million share repurchase authorization."

16:35 EDT TTM Technologies trading resumes

16:33 EDT Navidea receives acceptance letter from NYSE American - As previously disclosed, on August 14, 2018, Navidea Biopharmaceuticals, Inc. received a notification from the NYSE American LLC stating that Navidea was not in compliance with Section 1003aii and Section 1003fv of the NYSE American continued listing standards, which relate to stockholders' equity and the selling price per share of the company's securities. As required by the NYSE American, Navidea submitted a plan to the NYSE American by September 14, 2018 advising of actions it has taken or will take to regain compliance with the continued listing standards by February 14, 2020. On October 25, 2018, the company received a notification from the NYSE American that the company's plan to regain compliance was accepted. The Acceptance Letter also stated that the NYSE American had inadvertently omitted an additional deficiency from the Deficiency Letter. Specifically, the Deficiency Letter should have stated that Navidea is not in compliance with Section 1003aiii of the NYSE American Company Guide, which requires an issuer to have stockholders' equity of $6M or more if it has reported losses from continuing operations and/or net losses in its five most recent fiscal years. The Acceptance Letter noted that Navidea had stockholders' equity of $2.1M as of June 30, 2018, and has reported losses from continuing operations and/or net losses in its five most recent fiscal years ended December 31, 2017, and its shares have been selling at a low price per share.

16:33 EDT Vornado increases ownership interest in Farley Post Office joint venture to 95% - Vornado announced that it has increased its ownership interest in its Farley Post Office joint venture with the Related Companies to 95% by acquiring an additional 44.9% from Related. The purchase price was $41.5M plus the reimbursement of costs funded to date. Vornado is the managing partner. Related will continue to jointly develop and lease the property.

16:31 EDT SoCal Edison updates on circumstances around 2017 Thomas Fire - Southern California Edison remains committed to our customers and the communities affected by the 2017 Thomas Fire and wants to ensure that they and other important stakeholders are aware of updated information concerning the Thomas Fire. This information was included in SCE's Form 10-Q filed today with the Securities and Exchange Commission. As noted in that filing, SCE believes its electrical equipment was associated with an ignition near Koenigstein Road in Santa Paula - one of at least two origin points for the Thomas Fire. The company also continues to cooperate with the investigations being conducted by the California Department of Forestry and Fire Protection, the Ventura County Fire Department and the California Public Utilities Commission's Safety & Enforcement Division and will thoroughly review any findings and the associated evidence when they are made available. Based on currently available information, SCE believes that there are at least two separate points where the Thomas Fire started, one in the Anlauf Canyon area of Ventura County and another near Koenigstein Road in the city of Santa Paula. Witnesses have reported that a fire ignited along Koenigstein Road near an SCE power pole, and SCE believes that its equipment was associated with this ignition. SCE is continuing to analyze the progression of the fire from the Koenigstein Road ignition point and the extent of damages that may be attributable to that ignition. SCE has not determined whether the Anlauf Canyon area ignition involved SCE equipment.

16:27 EDT Hennessy Advisors Inc raises quarterly dividend 10% to 11c per share - The dividend will be paid on December 5, 2018, to shareholders of record as of November 13, 2018.

16:23 EDT Meta Financial names Brad Hanson CEO - Meta Financial Group announced that its board has appointed Brad Hanson, currently president of Meta Financial Group, MetaBank and Meta Payment Systems, to the additional role of CEO, effective today. Hanson will also remain on the Meta Board. Hanson replaces J. Tyler Haahr, who has stepped down as CEO. It is expected that Haahr will remain chairman and an employee through the company's Annual Meeting of Stockholders expected to be held in January 2019. Frederick Moore, currently lead director and vice chairman, has been appointed to serve as chairman effective following the date of the Annual Meeting.

16:20 EDT Oneok raises FY18 outlook - Net income guidance midpoint increases 9 percent to $1,180 million from $1,085 million. Adjusted EBITDA guidance midpoint increases 5 percent to $2,470 million from $2,350 million. Natural gas liquids segment adjusted EBITDA guidance midpoint increases 11 percent to $1,510 million from $1,365 million.

16:18 EDT MGM Resorts CEO says Q3 operating performance exceeded expectations - "Our third quarter operating performance exceeded our expectations despite the tough year on year comparison, resulting from robust casino business and an exceptionally strong event calendar last year. During the quarter, we successfully opened MGM Springfield, which has been well received by our customers. Earlier this month, we also officially opened the NoMad Hotel at Park MGM, which will help expand our customer reach. We remain highly focused on our strategic priorities, including maximizing the performance of our portfolio of premier properties, driving growth in free cash flow and delivering on our capital allocation strategy," said Jim Murren, Chairman and CEO of MGM Resorts International.

16:17 EDT KemPharm enters into licensing agreement with KVK Tech for Apadaz - KemPharm announced its entry into a definitive collaboration and license agreement with KVK Tech for the U.S. commercial rights of its FDA-approved prodrug product, Apadaz Under the terms of the agreement, KemPharm is eligible to receive up to an estimated $3.4M in pre-launch payments and certain cost reimbursements, including a $2.0M payment upon achievement of a specified milestone related to the initial formulary adoption of Apadaz, as well as an aggregate of up to $53M in milestone payments tied to specific net sales levels. In addition, net profits will be shared between KemPharm and KVK up to 50% based on achieving specified net sales levels. KVK has the exclusive right for all commercial, manufacturing, packaging and distribution activities for Apadaz in the U.S. and will be responsible for all regulatory and commercialization-related expenses. In addition, certain pre-launch expenses, including the costs of API and other materials for manufacturing, validation batches, inventory investments and other launch-specific costs will be shifted from KemPharm to KVK. Pre-launch activities that KemPharm and KVK will continue to collaborate on include outreach and plan adoption by pharmacy benefit managers and managed care organizations for the exclusive utilization of Apadaz as an alternative to currently available hydrocodone/acetaminophen products.

16:16 EDT Denny's reports Q3 domestic SSS up 1%

16:12 EDT Anadarko CEO says 'we delivered a very strong quarter' - "We delivered a very strong quarter with improving and attractive per-barrel margins, which helped drive cash flow from operations to more than $1.6 billion," said Al Walker, Anadarko Chairman, President and CEO. "Our cash flows were bolstered by the startup of an additional oil gathering and treating system in the Delaware Basin, where this year we have added 120,000 barrels per day of operated oil processing capacity with the Reeves and Loving ROTFs. This integrated upstream and midstream development approach provides a competitive advantage as we realize improved netback pricing for our product while also driving significant oil growth in the basin. As we look ahead to 2019, our focus will continue to be on delivering healthy oil growth within a capital-efficient framework," added Walker. "We have built a portfolio focused on properties with higher-margin oil and liquids that aligns well with our durable strategy of delivering attractive per-debt-adjusted-share growth metrics and returns to shareholders. We continue to have a high degree of confidence in our ability to deliver double-digit oil growth in a $50 oil-price environment, and look forward to communicating the details of the 2019 program later this quarter. Our disciplined growth approach, to be achieved while investing within a conservative cash-flow estimate and using cash and incremental free cash flow to fund share buybacks, debt reduction and potential dividend increases over time, is a differentiating strategy."

16:11 EDT BJ's Restaurants increases quarterly dividend 9.1% - The company's board increased the company's cash dividend by 9.1% to 12c per share of common stock, payable November 26 to shareholders of record at the close of business on November 12. While the company intends to pay quarterly cash dividends for the foreseeable future, dividends will be reviewed quarterly and declared by the Board of Directors at its discretion.

16:10 EDT BJ's Restaurants reports Q3 comparable restaurant sales increase of 6.9% - Reports Q3 total restaurant operating weeks increased approximately 3.1%.

16:09 EDT Facebook down 5% following Q3 earnings report - In after-hours trading, Facebook shares are down $7.24, or 4.95%, to $138.98.

16:08 EDT Facebook CEO sees 'huge opportunities ahead' in video and commerce - "Our community and business continue to grow quickly, and now more than 2 billion people use at least one of our services every day. We're building the best services for private messaging and stories, and there are huge opportunities ahead in video and commerce as well," said Mark Zuckerberg, Facebook founder and CEO.

16:04 EDT Amgen sees FY18 CapEx about $700M

16:01 EDT Amgen raises FY18 outlook

16:00 EDT TTM Technologies trading halted, news pending

14:43 EDT WSFS' Cypress reaches $1B in AUM - Assets under management by Cypress Capital Management, a division of WSFS Financial Corporation, have reached $1B. Kelly Wellborn, the President and Managing Executive of Cypress Capital Management, said: "This is a significant milestone for our Company and it energizes us to stay the course on our strategy, which has produced sustained financial returns for our clients. With a healthy mix of balanced asset allocation, a conservative investment approach, active management of securities, and a focus on tax efficiency and income generation, Cypress Capital's investment managers have a proven track record of delivering competitive and durable results for our clients through various business and credit cycles. I am very proud of our team and look forward to expanding our Customer base throughout the Greater Delaware Valley with our unique approach of customized solutions and individualized Customer service."

14:12 EDT Cloud Peak sees 2018 coal shipments from three mines 49M-51M tons - Sees FY18 adjusted EBITDA $60M-$70M. Sees FY18 CapEx $13M-$15M. 2018 guidance for Cloud Peak is taken from a company slides presentation.

13:57 EDT Alliance Resource Partners falls 12%, or $2.28, to $17.11

13:38 EDT Third Point says Campbell response 'insults the intelligence' of holders - Third Point, holder of approximately 7% of the outstanding common shares of Campbell Soup, issued a statement in response to Campbell's "rash critique" of its plan. Third Point said, "We believe Campbell's hastily-issued response to our plan released today insults the intelligence of its shareholders. Our 100 Day blueprint in no way endorses their 'plan', which was simply a limp promise to "do better", find a CEO after nearly six months of searching, and sell two of its business, including one of its crown jewels. Shareholders see through this floundering leadership team's attempts to hold on to their jobs and avoid accountability after twenty years of failing their shareholders. Our substantive operational, financial, and strategic approach is well-informed by five board nominees who have worked with Campbell in the past. We are confident that investors, unlike the Company, will take the time to understand our plan and vote the White Card for fresh ideas and a new path forward. After reviewing our full plan here, we encourage shareholders to also review The Independents and Fiction vs. Fact to understand more about why the Independent Slate will respect Shareholder voices, end the Insider Board Members' Reign of Error, and set Campbell on a new and profitable path. We urge all shareholders to VOTE the WHITE Proxy Card to elect the Independent Slate."

13:34 EDT General Electric shares drop below $10, now down $1.08 to $10.02

12:39 EDT Barnes Group announces long-term agreement with Boeing for 737 MAX parts - Barnes Aerospace, a business unit of Barnes Group (B), announced that it has entered into a long-term agreement with Boeing Propulsion, a unit of Boeing (BA), for the manufacture of innovative titanium components for the Boeing 737 MAX. "Barnes Aerospace will leverage its expertise and technology in the hot and super plastic forming of titanium fabrications to manufacture these products for the 737 MAX nacelle," the company said.

12:30 EDT EU opens probe into new JV proposed by Tata Steel, ThyssenKrupp - The European Commission said it has opened an in-depth investigation to assess the proposed creation of a joint venture by Tata Steel and ThyssenKrupp, under the EU Merger Regulation. At this stage, the Commission is concerned that the merger may reduce competition in the supply of various high-end steels. The Commission's initial market investigation raised several issues relating in particular to combining both companies' offer of certain specialty flat carbon steel and electrical steel products, namely: steel for automotive applications, which concerns various types of steel, predominantly galvanised, that are used to produce cars and car parts; metallic coated steel for packaging, which is used to produce various packaging solutions, such as food and aerosol cans; and grain oriented electrical steel, which is used to produce a variety of engineering products such as transformers. At this stage, the Commission is concerned that, following the transaction, customers would face a reduced choice in suppliers, as well as higher prices. These customers include various European companies, ranging from major corporations to numerous small and medium-size enterprises. Many compete with imported products in the EEA, or export their products outside Europe and compete globally. The Commission will now carry out an in-depth investigation into the effects of this transaction to determine whether its preliminary competition concerns are confirmed. The transaction was notified to the Commission on September 25, 2018. Tata Steel and ThyssenKrupp have decided not to submit commitments during the initial investigation to address the Commission's preliminary concerns. The Commission now has 90 working days, until March 19, 2019, to take a decision. The opening of an in-depth investigation does not prejudge the outcome of the investigation. Reference Link

12:27 EDT Take-Two rises as analysts stay bullish after big 'Red Dead' opening weekend - Shares of Take-Two (TTWO) are rising in afternoon trading after its subsidiary Rockstar Games said that its new release "Red Dead Redemption 2" achieved "the single-biggest opening weekend in the history of entertainment." The company noted that the game launched on a Friday, so its "opening weekend" is the same as its first three days. WHAT'S NEW: Rockstar Games said this morning that "Red Dead Redemption 2," which launched last Friday to critical acclaim, achieved over $725M in worldwide retail sell-through during its first three days. The game, according to the company, is the second-highest grossing entertainment launch of all time next to the developer's previously released title "Grand Theft Auto V," which achieved over $1B in retail sell-through in three days. The game is currently available on PlayStation 4 (SNE) and Xbox One (MSFT) consoles. STREET RESEARCH: Following the announcement, Baird analyst Colin Sebastian maintained an Outperform rating and $140 price target on Take-Two, saying that the "strong start" for "Red Dead Redemption 2" reinforces his positive view. The analyst noted that, for further context, Activision Blizzard's (ATVI) "Call of Duty: Black Ops 4" reported over $500M in sell-through during its opening weekend earlier this month. Sebastian also noted that the record launch increases the odds of upside potential for his third quarter target of roughly 18M units sold and fiscal 2019 estimates of about 22M units. In addition, the analyst said that the installed base creates a greater opportunity for the game's upcoming online launch, known as "Red Dead Online." Meanwhile, Piper Jaffray analyst Michael Olson backed an Overweight rating and $145 price target on Take-Two, noting that his firm estimates the game sold roughly 11M units in its opening weekend. While he is not raising its estimates, the 15.5M unit figure for FY19 appears to be conservative, Olson said. The analyst added that he believes buy-side expectations for "Call of Duty: Black Ops 4" are 23M-24M units by the end of December, while expectations for "Red Dead 2" were previously about 19M by the end of March, which now appear overly conservative. PRICE ACTION: In afternoon trading, shares of Take-Two are 9.7% higher to $122.58. Activision Blizzard shares, meanwhile, are up 2.3%, while shares of rival Electronic Arts (EA), which reports earnings after the close today, are 2.5% higher.

12:17 EDT Department of Justice clears WestRock acquisition of KapStone - WestRock (WRK) and KapStone Paper and Packaging (KS) announced that the U.S. Department of Justice has cleared WestRock's pending acquisition of KapStone through Whiskey Holdco. As this was the last antitrust approval required to complete the pending acquisition, WestRock and KapStone expect the pending acquisition to close on November 2, subject to customary closing conditions. As a result of the acquisition, among other things, Holdco will become the ultimate parent of WestRock, KapStone and their respective subsidiaries. Assuming the acquisition closes as expected, former KapStone stockholders will have the right to receive, with respect to each share of KapStone common stock they hold, either $35.00 in cash or, if they made and did not revoke a valid election in respect thereof by the election deadline at 5:00 p.m. New York City time on September 5, 2018, 0.4981 shares of Holdco common stock and cash in lieu of fractional shares. WestRock expects that shares of KapStone common stock will cease trading on the New York Stock Exchange prior to market open on November 5.

12:03 EDT Sony Interactive, Lenovo announce VR headset design patent license agreement - Sony Interactive Entertainment, a wholly-owned subsidiary of Sony Corporation (SNE), and Lenovo (LNVGY) announced they have signed a two-year patent license agreement. The agreement provides Lenovo with a license to use SIE's patented PlayStation VR industrial design for the Lenovo Mirage Solo virtual reality headset. "Lenovo is pleased to partner with Sony. The preeminence of the PS VR design is obvious. This agreement will allow us to work together to greatly enhance the design sophistication and appeal of the rapidly expanding VR field," said Yao Li, vice president of Lenovo Consumer Tablets and Smart Devices Product and Business Management.

12:00 EDT ACCO Brands falls -24.8% - ACCO Brands is down -24.8%, or -$2.47 to $7.50.

12:00 EDT Elevate Credit falls -39.5% - Elevate Credit is down -39.5%, or -$2.51 to $3.84.

12:00 EDT Under Armour rises 24.6% - Under Armour is up 24.6%, or $4.14 to $20.95.

11:55 EDT Huntsman CEO says 'actively marketing' stake in Venator Materials - Huntsman (HUN) CEO Peter Huntsman said on the company's Q3 call that during this past quarter the company purchased 1.3M shares for $37M. "This amount was much lower than I would like to see due to us being blacked out for much of the quarter. Reasons for the blackout include our own discussions with multiple parties regarding the potential sale of our shares in Venator. We continue to explore all options for monetizing our Venator shares and are actively marketing our current stake. We'll update the market when and if there's something new to announce," the CEO stated on the call. Huntsman added, according to a transcript of the call: "Over the years, I refrain from commenting on our share price. However, as I look at the remainder of the year, we're on track to being within 1% of $1.5 billion of EBITDA, by far our best performance ever. We remain on track to generate about 40% free cash flow to EBITDA. We're successfully bringing on new MDI capacity and expanding our downstream volumes in margins. We remain highly confident that our 2020 targets that we laid out at our Investor Day this past May. We will remain focused within reason on monetizing our position in Venator and when we realized, intend to dedicate a meaningful portion of those proceeds to our share repurchase program...Given where we are, the changes over the past few years and where we are going, I see a massive disconnect between our performance and our share price. Our company has never been in a better position to create shareholder value."

11:27 EDT IBM boosts share repurchase program by $4B - IBM said its board today declared a regular quarterly cash dividend of $1.57 per common share, payable December 10, to stockholders of record November 9, 2018. The board also authorized $4B in additional funds for use in the company's stock repurchase program. IBM said it will repurchase shares on the open market or in private transactions from time to time, depending on market conditions. This amount is in addition to approximately $1.4B remaining at the end of September 2018 from a prior authorization. With this new authorization, IBM will have approximately $5.4B for its stock repurchase program. Ginni Rometty, IBM chairman, president and CEO, said: "Our strong cash generation allows IBM to both invest in world-class innovations and to return money to shareholders."

11:22 EDT JPMorgan says buy JetBlue, sell Southwest as market de-rates - In a research note this morning, JPMorgan analyst Jamie Baker downgraded United Continental (UAL) and Spirit Airlines (SAVE) to Neutral, cut Southwest Airlines' (LUV) rating to Underweight, and upgraded JetBlue Airways (JBLU) to Overweight. While the analyst acknowledged that the industry remains on a path toward margin expansion for the first time since 2014, he argued that he cannot ignore the market's recent de-rating of nearly two multiple turns. MARGIN EXPANSION AHEAD AS MARKET DE-RATES: JPMorgan's Baker told investors this morning that he continues to believe that a "trading trifecta" has formed for U.S. Airlines in investors' favor. The analyst argued that the industry remains on a path toward margin expansion for the first time since 2014 amid lower year-over-year capacity, "robust" demand, "disciplinary" fuel, and no immediate risk to labor cost assumptions. Most stocks are "within 10% of their autumnal lows," suggesting seasonal tradewinds may lift equities as they often do, he contended. Baker also pointed out that 2019 consolidated capacity is 50 bps higher than anticipated, but still roughly a point below 2018. The analyst has trimmed 2019 earnings estimates over 10% except for Spirit Airlines, and introduced 2020 forecasts. For next year, he is above consensus for Delta, JetBlue and Spirit. In 2020, he has above consensus forecasts for American, Delta and Spirit. The analyst lowered his price target for American Airlines (AAL) to $46 from $53, Delta Air Lines (DAL) to $71 from $72, Southwest to $52 from $63, United to $95 from $98, while raising Spirit's target to $59 from $51. RATING CHANGES: After making changes to his estimates and price targets, JPMorgan's Baker downgraded United Continental and Spirit Airlines to Neutral from Overweight, downgraded Southwest Airlines to Underweight from Neutral, and upgraded JetBlue Airways to Overweight from Neutral. Southwest and United entered the year as underperformers, but may be poised to potentially exit as winners, he acknowledged. Nonetheless, he would rather focus on the "names that have not worked than pound the table on the two that have." For Southwest, Baker does not envision significant downside potential, but rather views the stock as "stalled" at current valuation levels until such time a trajectory toward higher margins can better be established. Meanwhile, JetBlue is the "cheapest" of the domestic airlines and its target multiple is the lowest, the analyst contended. He sees over 20% upside potential in the shares. Additionally, Baker reiterated a Neutral rating for American Airlines. While he agrees that most of the debt is aircraft related and at very attractive all-in rates, the analyst believes American will be left with a material non-operating expense disadvantage if the economic cycle deteriorates significantly. PRICE ACTION: In morning trading, shares of JetBlue have gained over 4% to $16.82, while both United and Spirit are fractionally up to $85.18 and $52.17, respectively. Shares of Southwest are fractionally down to $47.74.

11:17 EDT Apple says iPad Pros will be available November 7 - Says orders start today.

11:15 EDT Apple says 11-inch iPad Pro will start at $799

11:01 EDT First Long Island announces approval of $20M stock repurchase program - The First of Long Island Corporation, the parent company of The First National Bank of Long Island, announced that its Board of Directors has approved a stock repurchase program for shares of its common stock in an amount up to $20M.

10:56 EDT Allergan CEO 'worries' about prices in TV ads that are 'not relevant' to patient - Allergan CEO Brent Saunders made the comments in an interview on CNBC.

10:55 EDT Apple says iPad Pro is moving to USB-C

10:51 EDT Apple says iPad Pro powered by A12X Bionic - Says built on latest 7 nanometer technology. Says A12X has more than 10B transistors.

10:49 EDT Apple says iPad Pro now has Face ID

10:44 EDT Apple introduces new iPad Pro

10:41 EDT HCA Healthcare sees FY18 adj. EBITDA $8.7B-$8.9B

10:40 EDT Apple announces 60 new Today at Apple sessions - Says held over 18,000 sessions per week since launch. Says upgrading existing fleet and will continue to open flagships to amplify Today at Apple.

10:37 EDT Apple announces new MacBook Air coming to stores November 7 - Apple introduced a new MacBook Air, that the company said brings "a stunning 13-inch Retina display, Touch ID, the latest processors and an even more portable design to the world's most loved notebook." The new MacBook Air is available in three finishes - gold, space gray and silver - and features the Apple T2 Security Chip and Thunderbolt 3, the company stated. Starting at $1,199, the new MacBook Air is available to order today on apple.com. It will be available in Apple retail stores and through Apple Authorized Resellers starting Wednesday, November 7. The new graphics configuration option for MacBook Pro will be available to order on apple.com and in Apple retail stores and through Apple Authorized Resellers starting Wednesday, November 14, Apple added.

10:32 EDT Apple says new Mac mini will be available November 7 - Says orders start today. Says Mac mini uses 100% recycled aluminum.

10:30 EDT Apple says every Mac mini has T2 security chip - Says every new Mac mini starts with four cores. Says Mac mini can now go up to six cores. Says Mac mini can now go up to 64GB of memory.

10:24 EDT Apple says MacBook Air will start at $1,199 - Says orders start today and it will be available November 7.

10:20 EDT Apple says new MacBook Air has 17% less volume than predecessor - Says 10% thinner than previous Air. Says weighs 2.75 pounds, a quarter pound lighter than previous Air.

10:14 EDT Apple says MacBook Air features Touch ID

10:07 EDT Apple says Macs have install base of 100M - Comments made by Apple CEO Tim Cook at the Apple Special Event.

10:00 EDT Nautilus falls -15.3% - Nautilus is down -15.3%, or -$2.00 to $11.04.

10:00 EDT Elevate Credit falls -32.7% - Elevate Credit is down -32.7%, or -$2.08 to $4.28.

10:00 EDT Under Armour rises 21.7% - Under Armour is up 21.7%, or $3.65 to $20.46.

09:47 EDT Shutterstock falls -10.5% - Shutterstock is down -10.5%, or -$4.70 to $39.95.

09:47 EDT Elevate Credit falls -27.9% - Elevate Credit is down -27.9%, or -$1.77 to $4.58.

09:47 EDT Under Armour rises 19.0% - Under Armour is up 19.0%, or $3.19 to $20.00.

09:44 EDT MasterCard says seeing 'good spending' thus far in Q4

09:33 EDT Nevada reports September statewide gaming win up 1.26% to $991.22M - Nevada's Gaming Control Board reports Las Vegas Strip gaming win was down 3.71% in September to $546.02MM. Publicly traded companies in the casino gaming space include Boyd Gaming (BYD), Caesars (CZR), Las Vegas Sands (LVS), MGM Resorts (MGM), Penn National (PENN) and Wynn Resorts (WYNN).

09:32 EDT Travelers enters partnership with Gilbane, Triax Technologies - Travelers announced a collaboration with Gilbane and Triax Technologies. Travelers will review data collected from a variety of Triax's Spot-r IoT devices, including those being used at a 60,000-square-foot, six-floor Gilbane construction site in New York City over 20 months.

09:30 EDT Cytori Therapeutics announces receipt of Puregraft royalty milestone - Cytori Therapeutics announced that it has received a milestone payment of $1M from Bimini Technologies, LLC. The payment is a result of Bimini achieving the first $10M in gross profits for previous divestiture of the Puregraft product line. In 2013, Cytori entered into a Sale and Exclusive License/Supply Agreement with Bimini, pursuant to which Cytori sold to Bimini selected assets relating to Cytori's Puregraft product line, a series of standalone fat transplantation products that were developed to improve the predictability of outcomes for autologous fat grafting and aesthetic body contouring. Bimini may also be obligated to make certain additional milestone payments to Cytori, contingent upon future achievement of certain milestones relating to Bimini's gross profits from sales of the Puregraft products. The aggregate value of the consideration paid by Bimini to Cytori at the execution of the agreement in July 2013 was $5M.

09:30 EDT Dare Bioscience to present data from DARE-HRT1, DARE FRT-1 at AAPS - Dare Bioscience (DARE) announced that it will be presenting two late-breaking abstracts at the upcoming Association of Pharmaceutical Scientists, or AAPS, meeting. The presentations will focus on recently completed studies demonstrating pharmacokinetics and tolerability of DARE-HRT1, a novel 17ss- estradiol and progesterone intravaginal ring being developed for the treatment of vasomotor symptoms, or VMS, commonly associated with the onset of menopause, and DARE-FRT1, a novel progesterone intravaginal ring, or IVR, being developed for potential utilization in both in-vitro fertilization and pre-term birth. The current 505 candidates under development, DARE-HRT1 and DARE-FRT1, formerly JNP-0201 and JNP-0301 respectively, were licensed by Dare from Juniper (JNPR) in a transaction announced on April 25, as was the candidate DARE-OAB1, formerly JNP-0101.

09:24 EDT MasterCard says FX to have no real impact to revenue for FY18 - Sees FY18 effective tax rate ~19%. Comments from Q3 earnings conference call.

09:15 EDT Tapestry sees positive comps at Kate Spade in 2H - Sees low single digit growth at Coach brand in FY19. Sees positive comps for Kate Spade in 2H. Sees NII approximately $50M for FY19. Sees FY19 CapEx $300M-$325M, the peak level of spend over planning horizon. Says goal is to deliver strong revenue and operating income growth in FY19, while making the right strategic investments to support long-term vision and drive a return to both double-digit operating income and EPS growth in fiscal 2020.

09:12 EDT Globus Maritime regains compliance with Nasdaq - Globus Maritime announced that it has received a letter from Nasdaq, indicating that the company has regained compliance with the $1.00 per share minimum closing bid price requirement for continued listing on the Nasdaq Capital Market, pursuant to the marketplace rules. For at least 10 consecutive business days from October 15 to October 26, the closing bid price has been greater than $1.00. Nasdaq indicated within its letter that since the company has regained compliance with listing rule 5550, this matter is now closed.

09:03 EDT Tapestry says on track to achieve run-rate synergies of $100M-$115M in 2019 - Says will deliver "particularly strong" Black Friday offering. Expects Coach brand to achieve another year of "solid" revenue growth. Says new doors meeting or exceeding expectations at "high" levels of productivity. Sees double digit revenue growth for Kate Spade brand in FY19. Believes Kate Spade can ultimately achieve $2B in sales at significantly higher operating margins. Sees profitable sales growth for Stuart Weitzman in holiday quarter. Comments taken from the Q1 earnings conference call. Shares of Tapestry are up 4.2% in pre-market trading.

09:02 EDT Coca-Cola says has no plans 'at this stage' to get into cannabis

08:52 EDT Coca-Cola says completed North American bottling refranchise - Says remains disciplined in capital allocation. Expects capex of approx. $1.7B and net share repurchases of approx. $1B.

08:46 EDT Fairbanks Morse awarded contract for U.S. Navy's LPD Flight II class ship - Fairbanks Morse, an EnPro Industries company, has been awarded a contract to build and deliver the four main propulsion diesel engines that will power LPD 30, which will be the U.S. Navy's first LPD Flight II class ship. The newly designed ship will be based on the San Antonio-class hull, but the LPD Flight II is fitted with a fully capable flight deck and hangar, a well deck, and the vehicle and cargo capacities to support and sustain more than 500 combat-equipped Marines for up to 30 days. Each engine will feature common rail fuel injection technology.

08:44 EDT Coca-Cola says sales boosted by bottled water, low-sugar drinks - Says gaining share in a growing industry. Says currency headwinds were stronger than expected. Says top and bottom-line growth is broad-based. Says macroeconomic environment in Turkey, Middle East is "tough". Says natural disasters overshadowed pipeline in Japan. Says flood in Japan destroyed a bottling facility. Says Mexico continues to perform well. Says continues to deliver strong performance in North American marketplace. Says sales boosted by bottled water, low-sugar drinks. Says remains disciplined about allocation of capital and focus on M&A as an enabler. Says will aim to preserve Costa's unique capabilities. Says created Global Ventures group to get maximum value of acquisitions. Says believes leadership changes will set up company for success in years to come. Comments taken from Q3 earnings conference call.

08:43 EDT L3 Technologies awarded contract for U.S. Navy's Next Generation Jammer - L3 Technologies announced that it has been selected for a $36M demonstration of existing technologies contract award for the U.S. Navy's Next Generation Jammer Low Band program. The DET program encompasses a period of performance of 20 months, culminating in a demonstration at Naval Air Station Patuxent River, Maryland. The Next Generation Jammer will augment, and eventually replace, the ALQ-99 tactical jamming system currently integrated on the EA-18G Growler aircraft.

08:41 EDT Sparton, Ultra Electronics USSI JV awarded $39.6M contracts from U.S. Navy - Ultra Electronics Holdings and Sparton announce the award of subcontracts valued at $39.6M to their ERAPSCO joint venture, for the manufacture of sonobuoys for the United States Navy. The award is a GFY18 ERAPSCO Indefinite Delivery Indefinite Quantity, or IDIQ, contract release for sonobuoy requirements under ERAPSCO's five year contract. ERAPSCO will provide production subcontracts in the amount of $19.4M-$20.2M to Ultra Electronics USSI and Sparton DeLeon Springs, LLC respectively. Production will take place at Ultra Electronics USSI's Columbia City, IN facility and Sparton's DeLeon Springs, FL facility and is expected to be completed by September 2020.

08:39 EDT Carl Icahn raises stake in Dell Technologies to 9.3% - In a regulatory filing, it was disclosed that Carl Icahn may be deemed to be the beneficial owner of, in the aggregate, 18,529,497 shares of Dell Technologies Class V common stock. These shares were purchased for an aggregate purchase price of approximately $1.71B. This is an increase from Icahn's previously disclosed stake of 8.3%. Carl Icahn has previously stated in an open letter to stockholders of Dell Technologies Inc.'s DVMT Tracking Stock that he intends "to do everything in my power to STOP this proposed DVMT merger."

08:37 EDT Turtle Beach expands partnership with DreamHack - Turtle Beach announced the company is expanding its partnership with DreamHack in anticipation of the upcoming Atlanta festival taking place mid-November. This will be the third DreamHack event this year that Turtle Beach has sponsored and provided all gaming headsets for the Free to Play PC area, and the second consecutive event integrating the all-new Elite Atlas Pro Performance PC Gaming Headset.

08:37 EDT Canadian Solar subsidiary signs 15-year PPA in Silicon Valley and Monterey Bay - Canadian Solar announced its wholly owned subsidiary Recurrent Energy has signed two 15-year power purchase agreements, or PPA, with Silicon Valley Clean Energy and Monterey Bay Community Power for a 150 megawatt, or MWac, solar power system with 180 megawatt-hours, or MWh, of battery storage. This joint procurement effort represents the largest contracted solar-plus-storage project in California to date. This first-of-its-kind partnership resulted from a joint procurement process that Silicon Valley Clean Energy and Monterey Bay Community Power launched in September 2017 to source cost-effective, renewable power for their respective communities.

08:35 EDT B. Riley Financial authorizes $50M share repurchase program - B. Riley Financial announced its board has authorized a share repurchase program of up to $50M of its outstanding common shares.

08:33 EDT UroGen Pharma UGN-101 granted FDA Breakthrough Therapy Designation status - UroGen Pharma announced that the FDA has granted Breakthrough Therapy Designation status to the company's lead product candidate, UGN-101, for instillation. UGN-101 is currently in Phase 3 development for the treatment of patients with low-grade upper tract urothelial cancer. Breakthrough Therapy Designation is designed to expedite the development and review of new drugs to treat serious or life-threatening conditions, so patients may have access to therapies through FDA approval as soon as possible. The FDA previously granted both Orphan Drug and Fast Track designations to UGN-101 for the treatment of LG UTUC.

08:33 EDT Camden National raises dividend 30% to 30c - For the Q3 the Company declared a 30c dividend per share, which represents a 7c per share, or 30%, increase over the Q3 of FY17 and a dividend yield of 2.76% as of September 28.

08:28 EDT XCR Diagnostics, Luminex enter into license agreement - Privately held XCR Diagnostics Inc. and Luminex Corporation have entered into a non-exclusive, worldwide license agreement for XCR's proprietary Xtreme Chain Reaction nucleic acid amplification technology. The XCR technology enables extremely rapid thermal cycling protocols to achieve dramatically reduced assay turnaround times compared to traditional polymerase chain reaction. Financial terms were not disclosed.

08:23 EDT CymaBay initiates Phase 3 ENHANCE trial for treatment of PBC - CymaBay announced that the company has initiated the seladelpar Phase 3 registration study for the treatment of Primary Biliary Cholangitis, or PBC. The study is a 52-week, placebo-controlled, randomized, pHAse 3 study to evaluate the safety and efficacy of seladelpar, or ENHANCE trial, that will be conducted in more than 20 countries spanning five continents. The study is intended to establish the efficacy and safety of seladelpar for the treatment of PBC to support the submission of a global registration dossier with health authorities to obtain approval of seladelpar. Seladelpar is a drug candidate for PBC patients who are inadequate responders to ursodeoxycholic acid, the first line treatment of PBC, or who are intolerant to ursodeoxycholic acid.

08:20 EDT Canadian National to acquire The TransX Group of Companies - Canadian National announced it has reached an agreement to acquire Winnipeg-based The TransX Group of Companies, one of Canada's largest and oldest transportation companies. TransX will continue to be based in Winnipeg and will operate independently. The terms of the deal were not disclosed and the acquisition is subject to regulatory review by Competition Bureau Canada and Canada's Ministry of Transportation.

08:16 EDT Rockwell Collins appoints Dave Nieuwsma as CCOO - Rockwell Collins announced that Dave Nieuwsma has been named executive vice president and COO of the company's Interior Systems business based in Winston-Salem, North Carolina. He succeeds Werner Lieberherr who is leaving the company after helping to lead the successful integration of the B/E Aerospace business, which was acquired by Rockwell Collins in April 2017. Nieuwsma will report directly to Rockwell Collins Chairman, President and CEO Kelly Ortberg. Previously Nieuwsma was senior vice president of the company's Information Management Services business.

08:15 EDT ManTech awarded 10-year $158M contract by AFSPC - ManTech announced a 10-year contract with the U.S. Air Force Space Command, or AFSPC, totaling $158M to provide full-spectrum security services to protect mission-critical programs. The contract extends ManTech's long-standing support to the Air Force customer.

08:14 EDT MSA Safety deploys 750 breathing apparatus and cameras to Memphis FD - MSA Safety announced the deployment of 750 state-of-the-art G1 self-contained breathing apparatus, or SCBA, and integrated thermal imaging cameras to the Memphis Fire Department, or MFD. The contract was awarded to MSA in July and today's deployment represents a significant shift in the department's SCBA technology. It also makes Memphis the largest department in the U.S. to equip every firefighter with integrated thermal imaging technology.

08:13 EDT General Electric says targeting net debt/EBITDA less than 2.5x

08:12 EDT General Electric says issues with Power to persist longer than expected

08:09 EDT Red Dead Redemption 2 achieves $725M in worldwide retail sell-through - Rockstar Games (TTWO) is proud to announce that the critically acclaimed Red Dead Redemption 2 has achieved the single-biggest opening weekend in the history of entertainment*. With over $725 million in worldwide retail sell-through during its first three days, Red Dead Redemption 2 is the second-highest grossing entertainment launch of all time next to Rockstar Games' previously released title, Grand Theft Auto V, which achieved over $1 billion in retail sell-through in three days. Sony Interactive Entertainment (SNE), or SIE, also confirmed that Red Dead Redemption 2 set new records on the PlayStation Network for highest ever pre-orders, highest day one sales and highest sales for the first three days in market. Rockstar Games has partnered with SIE to bring PlayStation4 players first access to earn select online content in Red Dead Online that is planned to release this November.

08:08 EDT Mustang Bio announces initiation of Phase 1 in HER2-positive breast cancer - Mustang Bio announced that a Phase 1 clinical trial evaluating the safety and effectiveness of intraventricular delivery of CAR T cells to the brains of patients with HER2-positive breast cancer with brain metastases has been initiated. The trial, which is being conducted by City of Hope, a world-renowned independent cancer research and treatment center, is expected to enroll 21 patients, many of whom are likely to be women with HER2-positive breast cancer. According to the American Cancer Society, about 1 in 5 patients with breast cancer have HER2-positive cancer cells. Nearly half of patients with HER2-positive breast cancer develop brain metastases. The trial's primary objective is to determine the safety and recommended Phase 2 dosing of intraventricular delivery of HER2-specific CAR T cells. Secondary objectives include assessing cerebrospinal fluid and peripheral blood for HER2-CAR T cell persistence and endogenous immune system activation, describing changes in cytokine levels in the CSF and peripheral blood and describing changes in circulating tumor cells in the CSF.In addition, Mustang has announced that City of Hope has dosed the first patient in a Phase 1 clinical trial of HER2-specific CAR T cells in treating recurrent or refractory grade III-IV glioma. The trial will evaluate the side effects and best dose of HER2-specific CAR T cells in treating patients with grade III-IV glioma that has come back or does not respond to treatment.

08:07 EDT City of Hope opens CAR T trial for patients with HER2-positive breast cancer - Women with HER2-positive breast cancer that has spread to the brain need more treatment options, and City of Hope and Mustang Bio Inc. are meeting that challenge. A new City of Hope chimeric antigen receptor T cell trial - the first to focus on HER2-positive breast cancer patients with brain metastases - is now enrolling potential participants. The phase 1 trial will be conducted in an outpatient setting and will also be the first to use intraventricular delivery of CAR T cells directly to the brains of these patients. It will test the safety and effectiveness of the CAR T cell therapy for patients who have tried other types of treatment that are no longer effective. HER2 refers to a cancer-causing protein called human epidermal growth factor receptor-2, which is found on the cell surface of breast cancer cells, as well as some lung, colon and other cancer cells, and some melanoma cells. About 20 percent of breast cancer patients are HER2-positive, according to the American Cancer Society. CAR T cell therapy is a type of cell-based immunotherapy in which a patient's own T cells are reprogrammed to actively seek out and destroy cancerous cells. For this trial, the patient's T cells will be isolated from the blood and genetically engineered to express a CAR that allows these immune cells to target and eradicate HER2-positive cancer cells.

08:07 EDT iCAD says Navicent Health adopts breast cancer solutions - iCAD announced that its complete suite of breast health innovations including PowerLook Tomo Detection, a radiology workflow solution built on artificial intelligence, and the Xoft Axxent Electronic Brachytherapy System for the treatment of early-stage breast cancer using intraoperative radiation therapy, are now available at The Medical Center, Navicent Health, the second largest hospital in Georgia. Navicent Health, based in Macon, Ga., is now the first health system in the country to offer iCAD's solutions for both the detection and treatment of breast cancer.

08:06 EDT ContraVir completes final cohort dosing in CRV431 drug-drug interaction study - ContraVir Pharmaceuticals announced that it has completed dosing of the last cohort of healthy subjects for its CRV431 drug-drug interaction study. The single-dose crossover study evaluated subjects co-treated with Viread an approved treatment for chronic HBV infection. The DDI study is the second stage of CRV431's streamlined early clinical program, which is agreed upon with the U.S. FDA. The DDI study follows the completion of the first stage of the program, announced on September 18, 2018, where CRV431 met the primary endpoints of safety and tolerability in a single ascending dose study of healthy volunteers. The DDI study consists of three cohorts of the same 18 healthy volunteers. The first cohort of subjects received a single oral dose of CRV431 based on the selected dose from the SAD, followed by a 20-day pharmacokinetic study and washout period. The second cohort received 300mg of TDF followed by a six-day PK study and washout period. The Company has now completed dosing of the final cohort, where patients received both the SD of CRV431 and 300mg of TDF. The patients will now undergo a final PK study and observation period lasting 20 days, subject to availability of PK results. ContraVir expects to report results of the DDI study prior to the end of 2018. With an FDA agreement of an accelerated clinical program for CR431, ContraVir plans to bridge from the DDI study into a multi-dose 28-day pilot in HBV patients, which will assess the safety, tolerability, PK, and preliminary signals for antiviral efficacy, as well as identify clinically-relevant biomarkers of CRV431 with TDF.

07:56 EDT Commvault updates progress in its transformation initiative - Commvault provided an update on the progress of Commvault Advance, a multi-pronged transformation initiative. Commvault Advance began implementation internally nearly 18 months ago with an agenda of product development enhancements designed to make products more powerful and simple, continued with strategic partner actions in 2017 and 2018, and is most recently evidenced by reorganization and restructuring efforts in FY18. Commvault announced significant progress toward achieving Commvault Advance objectives, including: significant sales and marketing resource moves in support of a partner-led strategy, with a material portion of field resources being re-deployed in support of partner routes to market; Commvault Advance prioritized improvements to the company's bottom line performance, efforts that have shown substantial progress since being first announced in May 2018. The Company successfully completed a first round of cost reductions, with actions worldwide that reduced, consolidated and aligned resources across all functional areas. These efforts included an examination of contracted and full-time resources, T & E, and third-party expenses and resulted in a 61% increase in Q2 of FY19 year-over-year non-GAAP operating income. Commvault also reported substantial progress on a series of strategic governance initiatives announced as part of Commvault Advance and in agreement with Elliott Management.

07:55 EDT IPG Photonics trading halted, news pending

07:53 EDT Manulife Financial addressed the expected impact of new regulations - Manulife Financial addressed the expected impact of new regulations to the Saskatchewan Insurance Act made by the Government of Saskatchewan. The Saskatchewan regulations, published yesterday on the website of the Financial and Consumer Affairs Authority of Saskatchewan, limit the amount of premiums a life insurer may receive or accept for deposit in life insurance policies and associated side accounts. The basis of the claims by Mosten Investment against Manulife has been that life insurers can be compelled to accept unlimited premium payments. In effect, Mosten is seeking to use insurance policies to invest sizeable sums that have no connection to the insurance coverage.

07:52 EDT Pfizer: Revised FY18 guidance reflects 'recent unfavorable changes' in FX rates - "Pfizer's updated 2018 financial guidance primarily reflects: lower-than-anticipated Essential Health revenues, primarily due to continued legacy Hospira Sterile Injectable Pharmaceuticals product shortages in the U.S.; and recent unfavorable changes in foreign exchange rates in relation to the U.S. dollar from mid-July 2018 to mid-October 2018, primarily the weakening of certain emerging markets currencies and the euro."

07:44 EDT Coca-Cola reports Q3 adjusted operating margin up 575 bps - Operating margin, which included items impacting comparability, expanded approximately 600 basis points. Comparable operating margin (non-GAAP) improved 575 basis points, driven by divestitures of lower-margin bottling operations and the company's ongoing productivity efforts. These drivers were partially offset by an approximate 130 basis point headwind from the adoption of the new revenue recognition accounting standard and the impact of currency. The company continued to gain value share in total nonalcoholic ready-to-drink beverages.

07:42 EDT MyoKardia announces pipeline updates at its R&D Day - MyoKardia announced an update on its clinical-stage and emerging pipeline at its R&D Day. MyoKardia shared interim data from the PIONEER Open-Label Extension, or OLE, study of mavacamten for the treatment of symptomatic oHCM. Twelve of twenty patients with oHCM who previously completed MyoKardia's Phase 2 PIONEER-HCM trial have enrolled in PIONEER-OLE, and seven patients have completed a twelve-week assessment. Despite treatment with therapies such as beta blockers and calcium channel blockers, patients entered PIONEER-OLE with significant left ventricular outflow tract, or LVOT, obstruction. Following resumed mavacamten treatment with individualized dosing, evaluable patients in PIONEER-OLE achieved a statistically significant reduction in LVOT obstruction, to a mean provoked gradient of 22.3mmHg. For reference, LVOT obstruction is defined as a gradient of 30.0mmHg or greater at rest and a gradient of greater than 50.0mmHg is considered to be hemodynamically significant. In MyoKardia's Phase 2 PIONEER-HCM clinical trial of mavacamten, reductions in LVOT obstruction correlated to improvements in patients' symptoms and exercise capacity. All patients maintained ejection fractions well in the normal range of greater than 50%. There have been no significant adverse events reported. The longest duration of treatment thus far has been 25 weeks. MyoKardia plans to present additional data from PIONEER-OLE in Q1 of 2019, including gradient and ejection fraction data from longer term exposures, NT-proBNP and NYHA functional classification changes. MyoKardia announced the expansion of its pipeline with MYK-224, a second HCM-targeted candidate with differentiated pharmaceutical properties. Like mavacamten, MYK-224 is designed to correct excess contractility and address impaired diastolic function, without affecting myosin-actin cross-bridge kinetics or inducing an increase in calcium transient or energy burden. MYK-224 has been optimized to enable rapid dose adjustment and simplify dose finding in patients. MyoKardia plans to initiate a Phase 1 clinical trial in 2019 followed by a Phase 2a trial in 2020 addressing a complementary HCM population to mavacamten. MyoKardia shared preclinical data from its emerging LUS-1 program, a class of agents targeted at improving diastolic compliance, or the ability of the heart to relax and fill. Experience in preclinical studies and observations from clinical trials of mavacamten suggests that it may improve diastolic function and compliance. Building on these data, MyoKardia has discovered compounds that improve diastolic compliance with minimal impact on contractility. Preclinical data were shared that demonstrate that MyoKardia's proprietary agents successfully uncouple contractility inhibition from improved diastolic compliance, with a net positive impact on stroke volume. MyoKardia plans to share more mavacamten clinical data relating to its potential diastolic benefits at the upcoming American Heart Association Annual Meeting in November and will disclose additional preclinical data in relevant disease models for its LUS-1 program in 2019.

07:36 EDT NexPoint Residential raises dividend 10.0% to 27.5c - NexPoint Residential Trust announced that its board of directors has increased NXRT's quarterly dividend 10.0%, or by 2.5c per share, declaring a dividend of 27.5c per share of NXRT common stock, payable on December 31 to stockholders of record on December 17.

07:32 EDT Charah Solutions enters partnership with Oklahoma Construction Materials - Charah Solutions announced that it has partnered with Oklahoma Construction Materials, or OCM, and completed installation of new fly ash storage silos at OCM's rail terminal near Oklahoma City. OCM is a leading provider of transload and aggregate supply services. The new silos will serve customers in the greater Oklahoma City region where demand for quality fly ash is growing. The OCM facility provides customers quick and easy access to the nearby Interstate 35 and Interstate 40 to transport products to various regional jobsites efficiently. The new OCM silos can also supply the region with fly ash from other Charah Solutions' MultiSource materials network locations. The addition of the OCM facility adds to other recent additions to Charah Solutions' expanding MultiSource materials network in the South, New England, the Midwest, the Rocky Mountains and California. Charah Solutions has more than 30 nationwide sourcing locations to ensure a steady and reliable supply of Class C and Class F fly ash for ready mix concrete producers and other Charah Solutions' customers throughout the United States.

07:29 EDT U.S. Department of Energy extends contract with Aecom-led joint venture - AECOM announced that the U.S. Department of Energy has executed a 12-month contract extension to Washington River Protection Solutions, or WRPS, an AECOM-led joint venture with Atkins Nuclear Secured, member of the SNC-Lavalin Group, for its management of the waste storage tanks at the Hanford Site in Washington state. The approximate $700M extension will run from October 1, 2018, to September 20, 2019.

07:27 EDT Ares Commercial increases quarterly dividend by 2c to 31c per share - Ares Commercial announced that its board declared a 2c per common share increase in the quarterly dividend to 31c per common share for Q4 payable on January 15, 2019 to common stockholders of record as of December 28, 2018.

07:23 EDT Blueprint Medicines reports cash and equivalents $559.6M as of September 30 - Based on its current plans, Blueprint Medicines expects that its existing cash, cash equivalents and investments, excluding any potential option fees and milestone payments under its existing collaborations with Roche and CStone Pharmaceuticals, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2020.

07:21 EDT Incyte sees FY18 Jakafi net product revenues $1.37B-$1.4B - The company sees 2018 GAAP and Non-GAAP Jakafi net product revenues $1.37B - $1.4B, from $1.35B - $1.4B. Sees GAAP and Non-GAAP Iclusig net product revenues $80M-$85M.

07:19 EDT MKS Instruments to acquire Electro Scientific for $30.00 per share - MKS Instruments (MKSI) and Electro Scientific (ESIO) announced that they have entered into an agreement for MKS to acquire ESI for $30.00 per share. The all-cash transaction is valued at approximately $1B. The combined company is expected to have approximately $2.2B in pro forma annual revenue, based on the two companies' calendar 2017 historical results. The transaction is expected to be accretive to MKS' non-GAAP net earnings and free cash flow during the first 12 months post-closing. The combined company expects to realize $15M in annualized cost synergies within 18 to 36 months. MKS anticipates the acquisition will further advance the MKS strategy to enhance our Surround the WorkpieceSM offerings by adding systems expertise and deep technical understanding of laser materials processing interactions. ESI's knowledge in printed circuit board processing systems and other capabilities will provide MKS the opportunity to accelerate the roadmaps and performance of laser, motion and photonics portfolio. In addition, ESI brings a new platform of industrial markets enabling MKS to leverage its expertise more broadly. MKS intends to fund the transaction with a combination of available cash on hand and up to $650M in committed term loan debt financing. On a pro forma basis, as if the transaction closed on June 30, we expect the combined company to have a strong balance sheet with combined pro forma net cash and investments of approximately $400M and total term loan debt outstanding of $1B. This would result in pro forma trailing twelve month leverage, defined as debt to Adjusted EBITDA of 1.3 times and pro forma net leverage of 0.8 times. Actual leverage ratios will depend upon a number of factors and shall be determined at the time of the closing. The company has also obtained a commitment to upsize its asset based revolving credit facility to $100M. The transaction has been unanimously approved by the MKS and ESI boards of directors and is subject to customary closing conditions, including regulatory approvals and approval by ESI's shareholders, and is expected to close in Q1 of 2019.

07:18 EDT India Globalization Capital to re-list securities on alternative exchange - Globalization Capital announces that it is in the process of evaluating applications with alternative exchanges in the U.S. and Canada to list its common stock for public trading. IGC is working diligently to complete this process as quickly as possible and will provide additional updates in the very near term. Liquidity, elimination of unfair restrictions with respect to the commercialization of products, and customized support are expected to be key selection points. "We strongly disagree with the NYSE decision and will seek listing on an exchange that embraces our innovation. We have been transparent in disclosing our active legacy operations and should not be penalized for moving forward to commercialize products in the emerging U.S. cannabis industry. As a publicly traded company with cannabis ambitions, we are under great scrutiny and we intend to navigate the course for all our stakeholders and individuals seeking access to our innovative products including those under development," stated Ram Mukunda, CEO.

07:11 EDT Steven Madden reports Q3 gross margin 38.2% vs. 37.6% a year ago

07:09 EDT William Lyon Homes sees Q4 new home deliveries 1,360-1,475 units - Sees Q4 average sales price of homes closed of approximately $505,000 and pre-tax income before non-controlling interest of approximately $62M-$67M.

07:05 EDT AerCap announces new $200M share repurchase program - On October 29, 2018, our Board of Directors approved a new share repurchase program authorizing total repurchases of up to $200M of AerCap ordinary shares through March 31, 2019. Repurchases under the program may be made through open market purchases or privately negotiated transactions in accordance with applicable U.S. federal securities laws. The timing of repurchases and the exact number of common shares to be purchased will be determined by the Company's management, in its discretion, and will depend upon market conditions and other factors. The program will be funded using the Company's cash on hand and cash generated from operations. The program may be suspended or discontinued at any time.

07:04 EDT Waddell & Reed reports AUM up 2% compared to last year - Reports assets under management ended the quarter at $79.5B, increasing 1% compared to the prior quarter and declining 2% compared to the Q3 of FY17.

07:04 EDT Mondelez launches SnackFutures Innovation Hub - Mondelez International announced that it will launch a forward-thinking innovation hub called SnackFutures to "capitalize on changing consumer trends and emerging growth opportunities in snacking around the world. SnackFutures will be uniquely structured to bring together internal talent, an ecosystem of external partnerships and dedicated funding across three integrated mandates: Invention of new brands and businesses in key strategic areas; Reinvention of small-scale Mondelez brands with large-scale potential, and; Venturing with start-up entrepreneurs to seed new businesses." Mondelez International is targeting SnackFutures to contribute $100M to revenue growth by 2022.

07:02 EDT Under Armour sees $200M-$220M in pre-tax restructuring charges - The company expects to incur approximately $200M-$220M in pre-tax restructuring and related charges in connection with its previously announced 2018 restructuring plan. Through the third quarter of 2018, the company has recognized pre-tax costs of $154M, inclusive of $24M of pre-tax costs recognized in the third quarter.

06:59 EDT Nintendo says no revision to previous financial forecast - Nintendo says, "On Nintendo Switch, Super Mario Party will be released in October, then Pokemon: Let's Go! Pikachu/Let's Go! Eevee will be released in November, simultaneously with the Poke Ball Plus accessory that expands the depth of play with this title. In December, Super Smash Bros. Ultimate will be released at the same time as amiibo for some characters who are appearing in the series as fighters for the first time. We aim to further accelerate the momentum of Nintendo Switch by continuing to introduce compelling new software in addition to the popular titles that already have been released. For Nintendo 3DS, we will continue to leverage the platform's rich software library and its hardware install base to further expand sales of evergreen titles. In our smart-device business during this fiscal year, we plan to release the Mario Kart application for smart devices, Mario Kart Tour, while also focusing on service operations for the applications we have already released so that consumers can enjoy playing them for a long time."

06:58 EDT Coca-Cola sees FY18 underlying effective tax rate 20.3%

06:50 EDT Brinker reports Q1 system-wide SSS up 1.2% - Chili's company-owned comparable restaurant sales increased 2.0% in the first quarter of fiscal 2019 compared to the first quarter of fiscal 2018. Chili's U.S. franchise comparable restaurant sales increased 1.5% in the first quarter of fiscal 2019 compared to the first quarter of fiscal 2018. Maggiano's comparable restaurant sales were flat in the first quarter of fiscal 2019 compared to the first quarter of fiscal 2018. Chili's international franchise comparable restaurant sales decreased 3.0% in the first quarter of fiscal 2019 compared to the first quarter of fiscal 2018. Restaurant operating margin, as a percent of Company sales, was 11.1% in the first quarter of fiscal 2019 compared to 12.6% in the first quarter of fiscal 2018.

06:48 EDT Pfizer expects to repurchase approximately $12B of shares in 2018

06:41 EDT GE up 2c to $11.18 after Power reorganization, dividend cut and Q3 results

06:38 EDT Gilead announces 96-week results from Phase 3 study of Biktarvy - Gilead Sciences announced 96-week results from a Phase 3, randomized, double-blinded study evaluating the safety and efficacy of Biktarvy for the treatment of HIV-1 infection in treatment-naive adults. In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of dolutegravir and emtricitabine/tenofovir alafenamide (50 mg) through 96 weeks of therapy. The data were presented during a late-breaking abstract session at the 2018 HIV Glasgow conference in Glasgow, Scotland, UK. "This study demonstrated the high efficacy, high barrier to resistance and long-term tolerability profile of Biktarvy through 96 weeks, reaffirming its role as a first-line treatment option for appropriate adult HIV patients who are starting therapy," said Hans-Jurgen Stellbrink, MD, PhD, Professor of Internal Medicine, Infectious Diseases, at the University of Hamburg, Germany and lead study author. "Biktarvy was also shown to have few discontinuations due to adverse events through 96 weeks, which may be an important consideration for health care providers making clinical care decisions."

06:37 EDT GE CEO: GE a 'fundamentally strong company,' 'results far from full potential' - GE Chairman and CEO H. Lawrence Culp Jr. said, "After my first few weeks on the job, it's clear to me that GE is a fundamentally strong company with a talented team and great technology. However, our results are far from our full potential. We will heighten our sense of urgency and increase accountability across the organization to deliver better results. We are on the right path to create a more focused portfolio and strengthen our balance sheet. My priorities in my first 100 days are positioning our businesses to win, starting with Power, and accelerating deleveraging. We are moving with speed to improve our financial position, starting with the actions announced today. I look forward to updating you further on our progress in early 2019."

06:36 EDT General Electric intends to reorganize Power to accelerate improvements - GE intends to reorganize Power to accelerate the business' operating and financial improvements. GE plans to create two units - a unified Gas business combining GE's gas product and services groups, and a second unit constituting the portfolio of GE Power's other assets including Steam, Grid Solutions, Nuclear, and Power Conversion. The Company also intends to consolidate Power's headquarters structure to ensure these units can best serve their customers.

06:32 EDT Aetna reports medical membership totaled approximately 22.1M at Sept. 30

06:19 EDT LightInTheBox receives NYSE non-compliance notice - LightInTheBox announced that it received a letter from the NYSE, indicating that the company is "below criteria" due to the average closing price of the company's ADSs being less than $1.00 over a consecutive 30-trading-day period. The NYSE requires the average closing share price of a listed company's ADSs to be at least $1.00 per share over any consecutive 30 trading-day period. The company has six months to cure the deficiency and can regain compliance at any time if on the last trading day of any calendar month during the cure period the company has a closing share price of at least $1.00 and an average closing share price of at least $1.00 over the 30 trading-day period ending on the last trading day of that month. If at the expiration of the cure period, both a $1.00 closing share price on the last trading day of the cure period and a $1.00 average closing share price over the 30 trading-day period ending on the last trading day of the cure period are not attained, the NYSE will commence suspension and delisting procedures. The company will notify the NYSE that it will take steps to cure this deficiency within the prescribed timeframe. Until then, the company's ADSs will continue to be listed and traded on the NYSE, subject to compliance with other NYSE continued listing standards and other rights of the NYSE to delist the ADSs. The company is currently in compliance with all other NYSE continued listing standards. The NYSE notification does not affect the company's business operations or its Securities and Exchange Commission reporting requirements.

06:13 EDT Armada Hoffler announces investment in new project in South Carolina - Armada Hoffler announced that it will invest in Nexton Square, a new open-air lifestyle center currently under construction in Summerville, South Carolina. Located at the entrance to a new 4,500 acre master-planned community, Nexton Square will serve as the retail gateway to over 10,000 new single-family and multifamily residential units with plans for up to 148,000 square feet of space for local retailers, restaurants, and service providers. Armada Hoffler Properties will provide mezzanine loan financing that, combined with the proceeds from a senior construction loan, will complete the developer's capital stack. The Company will also provide construction management/development services for the project and will have a below market option to purchase the project upon completion. The initial phase of Nexton Square comprises 120,000 square feet across 13 buildings and is over 75% pre-leased or under letter of intent. The initial tenant spaces are anticipated to be delivered in the first quarter of 2019 with full completion by the end of 2020. Subsequent phases for an additional 28,000 square feet remain subject to lease-up. The total estimated cost of the project at full build-out is $45M.

06:11 EDT Fluor awarded Valero cogeneration project in Wales - Fluor (FLR) announced that it was awarded the engineering, procurement and construction of Valero Energy's (VLO) combined heat and power cogeneration project at its Pembroke Refinery in Wales, UK. Fluor booked the undisclosed contract value in the third quarter of 2018. Fluor's scope includes design, procurement, construction and commissioning support for the new 45 Mega Volt Amps natural gas-fired combustion turbine generator system that will supply power and steam to enhance the refinery's energy efficiency and operations. The scope also includes substations, transformers, electrical and piping tie-ins and a fuel gas pipeline system. The project, the first to receive planning permission as a Development of National Significance process under the Planning (Wales) Act 2015, will be executed on a cost reimbursable basis by an integrated engineering team located at Fluor's office in Farnborough and at the Pembroke Refinery.

06:07 EDT TransUnion awarded multi-year contract by FEDLINK - TransUnion announced it has been awarded a multi-year contract by The Federal Library and Information Network. This will significantly broaden federal agencies' access to TransUnion's credit data, public & alternative data, analytics, remote identity and device identification, fraud prevention managed services and investigative risk management offerings.

06:01 EDT Genesee & Wyoming authorizes new $500M share repurchase plan

05:25 EDT BioXcel says on track to initiate BXCL501 first-in-human PK and safety study - BioXcel Therapeutics provided an update on the company's progress advancing its lead neuroscience program, BXCL501, a proprietary, first-in-class sublingual thin film formulation of dexmedetomidine hydrochloride being developed for the acute treatment of agitation. BTI is on track to initiate an IND-opening Phase 1 pharmacokinetic, or PK, and safety study with BXCL501 by the end of this year, following approval of its IND application. Prior to its recently completed pre-IND meeting with the FDA, BTI submitted a pre-IND briefing book containing regulatory, chemistry, manufacturing, controls, or CMC, and non-clinical work, along with a proposed clinical study synopsis and a broader development plan. During the pre-IND meeting with the FDA, BTI received valuable feedback that will help guide further clinical development of BXCL501.