Stockwinners Market Radar for October 22, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

HLX

Hot Stocks

19:25 EDT Helix Energy reports Q3 adjusted EBITDA $58.6M vs. $30.5M last year - CEO Owen Kratz says: "The sequential improvement in our financial performance resulted primarily from improvements in our Robotics segment, with increased trenching operations during the quarter and near full utilization of our chartered vessel fleet. Our Well Intervention segment saw continued strong operational performance and high utilization of our intervention vessels, despite lower IRS rental unit utilization and idle time between projects on our Q4000 vessel. In the fourth quarter our operations will be impacted by the normal winter slowdown in the North Sea and expected low activity levels in the Gulf of Mexico. Our market is still weak and challenging, but we remain committed to finishing the year with strong operational execution and cost discipline."
I EUTLF

Hot Stocks

19:11 EDT Intelsat, SES, Eutelsat in transition on planning to support 5G deployment - The C-Band Alliance, which includes Intelsat (I), SES, Eutelsat (EUTLF) and Telesat announced that up to 200 MHz of mid-band spectrum could be cleared, dependent upon demand, under its updated proposal to the U.S. Federal Communications Commission opening new spectrum to support 5G wireless deployment while protecting current users. This updated commitment will be reflected in comment filings due October 29 under the FCC Notice of Proposed Rule Making proceeding. The proposal increases by 80% the amount of spectrum that could be made available for 5G terrestrial use as compared to the initial proposal made by Intelsat and SES. This announcement allows the CBA and its members to engage in detailed planning of the complicated task of moving customers to different frequency assignments, facilitated through new satellite capacity and innovative technical solutions, implementing new ground infrastructure and modifying the significant existing infrastructure deployed nationwide.
CDNS...

Hot Stocks

19:05 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: Cadence Design Systems (CDNS) up 10.8%... SS&C Technologies Holdings (SSNC) up 7.1%... First Bank (FRBA) up 4.1%... Zions Bancorp (ZION) up 2.9%... Renasant (RNST) up 0.9%... Crane Co (CR) up 0.4%... Brown & Brown (BRO) up 0.3%. ALSO HIGHER: Chembio Diagnostics (CEMI) up 4.9% after guiding Q3 revenue... RH (RH) up 0.7% after being initiated with Outperform at Wedbush. DOWN AFTER EARNINGS: Moelis & Co (MC) down 11.0%... TD Ameritrade (AMTD) down 1.8%. ALSO LOWER: Affimed N.V. (AFMD) down 3.2% after equity offering... Proteostasis Therapeutics (PTI) down 2.5% after equity offering... Eiger BioPharmaceuticals (EIGR) down 1.9% after equity offering.
BK

Hot Stocks

18:20 EDT BNY Mellon, Bank of the West reach pact on new real-time payments solution - BNY Mellon and Bank of the West announced agreement today where BNY Mellon is providing Bank of the West extended capabilities to help deliver faster payments solutions for its commercial clients through connectivity to RTP and Disbursements with Zelle. "This reseller agreement is part of our strategy to help banks accelerate payment innovation," said Tony Brady, Digital Platform Officer for BNY Mellon's Treasury Services business. "In turn, banks can 'pay it forward' to their clients. It's part of the responsibility we take on as a leader in modernizing the global payment ecosystem."
CLGX

Hot Stocks

18:07 EDT CoreLogic to acquire Symbility Solutions for CAD159.5M - Symbility Solutions and CoreLogic announced the execution of an arrangement agreement pursuant to which CoreLogic has agreed to acquire Symbility Solutions. CoreLogic currently owns 28% of the Symbility shares. Under the terms of the Agreement, CoreLogic has agreed to acquire from each of the holders of Symbility's outstanding common shares, the Symbility common shares not owned by CoreLogic or its affiliates, for C$0.615 in cash for each Symbility share. In addition, all holders of outstanding stock options of Symbility will be entitled to receive the "in-the-money" value of such stock options. This represents an aggregate value on a fully diluted basis of approximately C$159.5M.
ABBV

Hot Stocks

18:04 EDT AbbVie reports 'positive' data from Phase 2b/3 study of upadacitinib - AbbVie announced positive results from U-ACHIEVE, an ongoing Phase 2b/3 dose-ranging study evaluating upadacitinib, an investigational JAK1-selective inhibitor, for induction and maintenance therapy in adult patients with moderately to severely active ulcerative colitis. After 8 weeks, upadacitinib (15/30/45 mg, once daily) met the primary endpoint of clinical remission and all ranked secondary endpoints. These clinical data, in addition to patient-reported outcomes data from the study, are being presented at United European Gastroenterology Week 2018 in Vienna, Austria. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established. The study showed that significantly more patients achieved clinical remission with upadacitinib (14/14/20 percent of patients in the 15/30/45 mg groups) compared to placebo (0 percent) at week 8.1 Additionally, key secondary endpoints were also achieved at week 8 across the upadacitinib 15/30/45 mg groups, including endoscopic improvement, clinical remission and clinical response. The upadacitinib 7.5 mg group did not meet the primary endpoint. These results are being presented October 22 during an oral presentation entitled "Efficacy and safety of upadacitinib as an induction therapy for patients with moderately to severely active ulcerative colitis: data from the phase 2b study U-ACHIEVE" from 2:12 - 2:24 p.m. CEST.
CE

Hot Stocks

18:00 EDT Celanese announces 3c per lb increase on ethyl acetate - Celanese announced it will increase list and off-list selling prices for ethyl acetate in the Americas region by 3c per lb. The price increases below are for orders shipped and will be effective Nov. 1, 2018, or as contracts otherwise allow, and are incremental to any previously announced increases.
SNX

Hot Stocks

17:42 EDT Synnex director Matthew Miau buys over $9.5M in company stock - Synnex director Matthew Miau disclosed in a filing that he had purchased 122,202 shares of common stock at an average price of $78.27 per share on October 19. The total transaction value of the purchase was $9,564,384.
TMST

Hot Stocks

17:30 EDT Luminus Management reports 5.58% passive stake in TimkenSteel
SLM

Hot Stocks

17:23 EDT Sallie Mae reports Q3 net interest margin up 15bps at 6.00% - Q3 Private education loan originations of $2.1B, up 12%. Average private education loans outstanding of $19.3B, up 19% from last year. Average yield on the private education loan portfolio was 9.16%, up 66bps. Private education loan provision for loan losses was $42M, down from $53M. Private education loans in forbearance were 3.4% of private education loans in repayment and forbearance, up from 3.2%. Private education loan delinquencies as a percentage of private education loans in repayment were 2.3%, down from 2.6%.
BA

Hot Stocks

17:17 EDT Correction: Boeing maintains quarterly dividend of $1.71 - The dividend is payable December 7, 2018, to shareholders of record as of November 9, 2018.
BA

Hot Stocks

17:16 EDT Boeing maintains quarterly dividend of $1.31 - The dividend is payable December 7, 2018, to shareholders of record as of November 9, 2018.
JOE MAR

Hot Stocks

17:15 EDT St. Joe Company, InterMountain break ground on New Towneplace Suites Hotel - The St. Joe Company (JOE) and InterMountain Management, LLC announce the groundbreaking for a new TownePlace Suites hotel in Panama City Beach, Florida, will take place this week. This 124-room TownePlace Suites by Marriott (MAR) will be located adjacent to Frank Brown Park and will include amenities such as a fitness center, pool, business center and more. TownePlace Suites' model offers an extended stay hotel with suites designed to provide everything travelers need to live life uninterrupted. St. Joe and InterMountain believe this hotel brand is perfectly suited for the growing family-oriented tourism market of Panama City Beach, conveniently located close to the activities associated with the area's beautiful beaches, Frank Brown Park and the Panama City Beach Aquatic Center, as well as, the shopping and entertainment center of Pier Park.
IAG

Hot Stocks

17:09 EDT IAMGold announces positive results from a feasibility study for Senegal project - IAMGOLD announced positive results from a Feasibility Study for its Boto Gold Project in Senegal, West Africa. The results outline an economically robust project with an anticipated low cost of production and long operating life. The FS demonstrates a significant economic and operational improvement compared to the Pre-feasibility Study results announced in February of this year. The FS will be used to support an application for a mining concession in the fourth quarter of 2018. Proven and Probable Reserves increased by 0.51 million ounces to 1.93 million ounces grading 1.71 g/t Au versus the P&P Reserves from thePFS. Indicated Resources of 2.49 million ounces grading 1.61 g/t Au.
HWBK

Hot Stocks

17:09 EDT Endeavour Capital reports 7.3% passive stake in Hawthorn Bancshares
BRO

Hot Stocks

17:03 EDT Brown & Brown reports Q3 organic revenue up 1.4%
SFNC

Hot Stocks

17:03 EDT Simmons First National reports Q3 core net interest margin 3.71%
NBTB

Hot Stocks

16:54 EDT NBT Bancorp raises quarterly dividend to 26c from 25c per share - The dividend will be paid on December 14, 2018 to shareholders of record as of November 30, 2018.
PERY

Hot Stocks

16:51 EDT Perry Ellis announces completion of its acquisition in $437M transaction - Perry Ellis International announced the successful completion of its acquisition by an entity controlled by George Feldenkreis in which Perry Ellis has become a private company through a $437M transaction. Under the terms of the Feldenkreis merger agreement, Perry Ellis' unaffiliated shareholders will receive $27.50 per share in cash. Shares of Perry Ellis ceased trading on the Nasdaq Global Select Market prior to the open of trading on October 22, 2018 and will no longer be listed on an exchange or quotation system."Today, Perry Ellis enters an exciting new chapter as a private enterprise," said George Feldenkreis. "I want to thank all of our associates at Perry Ellis for their support and hard work to accomplish this transaction. We are also very grateful to our bankers and advisors that have helped the Feldenkreis family to complete this herculean job." "We are thrilled to provide a financing solution that has enabled the founding family of Perry Ellis to set this storied company on a new and exciting path for future success," said Josh Pack, managing partner of Fortress Investment Group.
FBK

Hot Stocks

16:49 EDT FB Financial authorizes $50M common stock repurchase program - FB Financial's board authorized the repurchase of up to $50M of the company's outstanding common stock, which will remain in effect until October 22, 2019.
FBK

Hot Stocks

16:48 EDT FB Financial increases quarterly dividend 33% - FB Financial Corporation announced that its board declared a quarterly cash dividend of 8c per share, which represents a 33% increase. The dividend is payable on November 15 to shareholders of record as of November 1.
UVE

Hot Stocks

16:47 EDT Universal Insurance announces expected financial impact from weather events - Universal Insurance Holdings announced the expected financial impact to the Company from recent weather events, including Tropical Storm Gordon and Hurricane Florence as well as Hurricane Michael. Using claims information received to date and post event catastrophe model estimations, the company expects the following: Tropical Storm Gordon initially made landfall on the U.S. Gulf Coast on September 4 primarily impacting Florida, Alabama, Louisiana, and Mississippi. The storm is expected to result in both gross and net pre-tax losses and loss adjustment expenses of $2.5M. Hurricane Florence initially made landfall as a strong Category 1 hurricane in North Carolina on September 14 primarily impacting North Carolina, South Carolina, and Virginia. The storm is expected to produce gross losses and loss adjustment expenses of $35-45 million, resulting in net pre-tax losses and loss adjustment expenses of $5M. Hurricane Michael initially made landfall as a strong Category 4 hurricane along the Florida Panhandle on October 10 primarily impacting Florida, Georgia, and several other Southeastern U.S. states. The storm is expected to produce gross losses and loss adjustment expenses of $300M-350M, resulting in net pre-tax losses and loss adjustment expenses of $35M. In addition, to the extent the Company experiences any additional reinsurance recoveries from its supplemental Non-Florida reinsurance program, those recoveries could serve to partially reduce its $35M retention.
SENS

Hot Stocks

16:46 EDT Senseonics announces Aetna's positive coverage decision for Eversense - Senseonics Holdings announced that Aetna, the third largest commercial health plan provider in the United States, is providing coverage for Eversense, effective immediately. Aetna's plan provides coverage for approximately 22 million lives in the United States. This recent coverage decision adds to the growing body of payers processing claims and paying for Eversense in the U.S. "We are pleased that one of the largest national payers in the U.S. is now covering Eversense, and that Aetna recognizes the value of CGM and the value Eversense can bring to the market in terms of patient adherence," said Tim Goodnow, President and Chief Executive Officer of Senseonics. "We believe this coverage decision represents a major milestone and has
CEMI

Hot Stocks

16:44 EDT Chembio Diagnostics acquires opTricon GmbH for $5.5M in cash - Chembioannounced that it has signed a definitive agreement to acquire opTricon GmbH, a privately-held developer and manufacturer of hand-held analyzers for rapid diagnostic tests. Under terms of the purchase agreement, Chembio will pay $5.5M in cash, and the transaction is expected to close on October 31, subject to standard closing conditions.Since 2015, Chembio and opTricon have collaborated to develop the DPP Micro Reader, a hand-held, battery-operated analyzer that uses an innovative image sensor to provide a quantitative interpretation of diagnostic results when combined with Chembio's proprietary DPP tests. Located in Berlin's Science & Technology Park, opTricon will become Chembio's Center-of-Excellence for optical technology and serve as Chembio's European headquarters. As part of its ongoing business, opTricon will continue to develop and manufacture hand-held analyzers for OEM customers which do not compete with Chembio. "Long term success in the point-of-care infectious disease market requires innovation that extends beyond the diagnostic test to include data capture, transmission, and storage," stated John Sperzel, Chembio's Chief Executive Officer. "Our scientific team is focused on the development of DPP tests that provide increased sensitivity, advanced multiplexing, and quantitative results which are collectively enhanced by the use of an optical reader. The acquisition of opTricon will enable us to further advance our innovative technology development
HSTM

Hot Stocks

16:38 EDT HealthStream CFO Gerard Hayden, Jr. resigns, Scott Roberts named interim CFO - HealthStream's CFO, Gerard Hayden, Jr., has tendered his resignation, which will be effective following the company's filing of Form 10-K for the full-year 2018, which we expect to occur in March 2019. Afterwards, he will remain available to HealthStream as a Senior Executive Advisor. The Board of Directors will oversee the process to fill the CFO position. To ensure a smooth transition following Hayden's departure as CFO, Scott Roberts, HealthStream's Vice President, Accounting & Finance, will serve as Interim CFO. Roberts, who is a Certified Public Accountant, joined HealthStream 16 years ago after working at Ernst & Young. His broad experience in public financial reporting and deep knowledge of financial operations, both in general and Company-specific terms, makes him particularly qualified to serve as an Interim CFO and as a candidate to fill the position permanently.
RMD

Hot Stocks

16:37 EDT ResMed says it won German patent infringement case against Fisher & Paykel - ResMed announced the results of a court and patent office ruling in Germany in ResMed's favor. A trial court ruling from the Munich District Court states that the headgear used on two Fisher & Paykel CPAP masks - the Simplus full face and Eson 2 nasal mask - infringes ResMed patent EP 2 373 368 B1 in Germany. In a separate decision, the Opposition Division of the European Patent Office had already decided that the patent asserted against Fisher & Paykel is valid. Each decision may be appealed by Fisher & Paykel. "We applaud the Munich District Court for reaching this just finding, and are exploring all options in light of the fact that Fisher & Paykel is selling CPAP masks with headgear that infringes a valid ResMed patent in Germany," said ResMed Chief Administrative Officer and Global General Counsel David Pendarvis. "We will continue to defend our intellectual property here and wherever necessary to ensure that patients worldwide continue to receive the high-quality care they deserve," Pendarvis said.
WEX

Hot Stocks

16:36 EDT Wex signs agreement to acquire Noventis - WEX announced the signing of an agreement to acquire Noventis, an electronic payments network focused on optimizing payment delivery for bills and invoices to commercial entities. WEX has a longstanding relationship with Noventis as a critical supplier of virtual cards that enable payment transactions through Noventis' network. WilmerHale LLP and Sidley Austin LLP provided legal counsel to WEX. Raymond James acted as financial advisor to Noventis while Akin Gump Strauss Hauer & Feld and Schulte Roth & Zabel provided legal counsel.
GOOG

Hot Stocks

16:36 EDT Google's YouTube investing $20M in education resources for 'EduTubers' - YouTube is investing $20 million toward educational content through its new Learning Fund program. In an entry on its blog page, YouTube said: " People all over the world use YouTube to learn and follow their passions. Whether it's learning prerequisites for a college course or how to compete in Olympic javelin throwing, everyone seems to have turned to YouTube to learn something. Many of these learning stories are powered by an incredible community of EduTubers like PhysicsGirl and Manual do Mundo, whose videos have demonstrated the appeal of content that enriches as well as entertains. We've already completed our first round of investment in some of the most respected names in online education like TED-Ed or Hank and John Green's Crash Course. We're also supporting many of our emerging EduTubers like Socratica and Linda Raynier. Creators who are interested in applying to the Learning Fund can sign up for more information here. In addition to investing in EduTubers through the Learning Fund, we're also developing new YouTube Originals focused on learning like Mind Field: Season 3 from Vsauce creator Michael Stevens, and a new series with Vox Entertainment which was announced earlier this month." Reference Link
HXL

Hot Stocks

16:33 EDT Hexcel backs FY18 free cash flow greater than $230M - Backs FY18 accrual basis capital expenditures of $170M-$190M.
BIOS

Hot Stocks

16:31 EDT BioScrip names John McMahon CAO - BioScrip announced the appointment of John McMahon as Vice President, Controller and Chief Accounting Officer of the company, effective October 19, 2018. McMahon is a certified public accountant and has more than 25 years of accounting and finance experience, including over a decade in principal accounting officer roles at publicly traded companies, such as Heska Corporation where he was the chief financial officer and Advanced Energy Industries, Inc. where he was the corporate controller.
HSC

Hot Stocks

16:31 EDT Harsco names CEO Grasberger III as chairman of the board - Harsco Corp. announced that F. Nicholas Grasberger III, President and Chief Executive Officer, has been elected Chairman of the Board of Directors, effective immediately. Grasberger succeeds David C. Everitt, who has served as Non-Executive Chairman since August 2014 and a director since 2010. Everitt has been appointed independent Lead Director. Additionally, the Harsco Board of Directors today announced that Carolann Haznedar has been elected as an independent Director of the Board, effective immediately.
OLP

Hot Stocks

16:28 EDT One Liberty Properties acquires industrial property in Colorado for $12.8M - One Liberty Properties announced that it acquired, in a sale-leaseback transaction, a 63,882 square foot industrial/office property on 7.35 acres located in Englewood, Colorado, a suburb of Denver, for $12.8M. Englewood, Colorado is located 15 miles southeast of downtown Denver and just a short distance from the Centennial Airport. The building, which was constructed in 2014, is net leased to Applied Control Equipment through 2030 for an aggregate annual base rent of approximately $926,000, which increases 2.5% annually. The facility is used for warehouse and distribution purposes and also serves as the tenant's corporate headquarters. Applied Control is the exclusive sales and service provider in the Rocky Mountain region for Emerson Electric's automated solutions division.
ASR

Hot Stocks

16:27 EDT Asur reports total Q3 Passenger Traffic up 6.3% - ASUR's total passenger traffic in Q3 increased 6.3% YoY to 13.3M passengers, reflecting increases of 6.7% in traffic in Mexico, 3.8% in Puerto Rico and 7.3% in Colombia. The 6.7% YoY growth in passenger traffic in Mexico reflects increases of 10.5% and 2.8% in domestic and international traffic, respectively. Cancun was the main driver behind traffic growth, with increases of 10.6% and 2.8% in domestic and international traffic, respectively, with the majority of ASUR's other Mexican airports also contributing to higher traffic. Traffic in Puerto Rico increased 3.8% YoY, recovering following the impact of Hurricane Maria, which hit the island in September 2017. Domestic traffic increased 5.3% YoY, more than offsetting a decline of 5.9% in international traffic. Colombia reported a 7.3% YoY increase in total traffic driven by increases of 12.4% and 6.4% in international and domestic traffic, respectively.
COLM GPS

Hot Stocks

16:27 EDT Columbia Sportswear's board elects former CFO of Gap to serve as director - Columbia Sportswear (COLM) announced that its board of directors has elected Sabrina Simmons former EVP and CFO of Gap (GPS), to serve as a director and member of the Nominating and Corporate Governance and Compensation Committees, effective immediately. The board intends to nominate Ms. Simmons for election by the company's shareholders to a full term as a board member at the company's 2019 annual meeting of shareholders.
EQ

Hot Stocks

16:19 EDT Partner Fund Management reports 7.2% passive stake in Equillium
SYKE

Hot Stocks

16:19 EDT Sykes Enterprises to acquire Symphony Ventures Limited for $69M - Sykes Enterprises announced it has entered into a definitive agreement to acquire Symphony Ventures Limited. Founded in 2014 and headquartered in London, UK, Symphony is a premier provider to blue chip clients, offering RPA consulting, implementation, hosting and managed services. Approximately 200 people strong, Symphony has one of the largest independent global teams of Intelligent Automation experts. Under the terms of the acquisition agreement, the company will pay a cash purchase price of approximately $69M for 100% ownership of Symphony Ventures Limited, which is expected to be funded through a combination of cash on hand and the company's credit facility. The purchase price is approximately 2.0x 2019 projected revenues. The transaction is subject to customary closing conditions and is expected to close on or about November 1. Symphony, through its innovative practices, has developed a well-recognized brand in the industry, which it is expected to retain post acquisition. The management team will remain in place after the transaction closes and will continue to oversee the day-to-day operations of the business. The transaction is expected to be dilutive on a GAAP and neutral on a non-GAAP basis to 2018 diluted earnings per share.
COLM...

Hot Stocks

16:16 EDT Columbia Sportswear names former Gap CFO Simmons to board - Columbia Sportswear (COLM) announced that its board of directors has elected Sabrina Simmons to serve as a director and member of the Nominating and Corporate Governance and Compensation Committees, effective immediately. The board intends to nominate Simmons for election by the company's shareholders to a full term as a board member at the company's 2019 annual meeting of shareholders. Simmons currently serves as a member of the board and audit and finance committee chair for Williams-Sonoma Inc. (WSM) and as a member of the board and audit committee chair for e.l.f. Cosmetics, Inc. (ELF). She served as Executive Vice President and Chief Financial Officer of Gap, Inc. (GPS) from 2008 to 2017.
SSNC

Hot Stocks

16:12 EDT SS&C up 6% to $53.00 after guiding Q3 results above consensus
INAP

Hot Stocks

16:12 EDT Gamco Investors lowers stake in Internap to 9.7% from 10.8%
SSNC

Hot Stocks

16:09 EDT SS&C CEO says 'our markets remain robust' - "SS&C continues to execute. Our markets remain robust and we are delivering significant value to our customers. DST, in particular, is making significant progress and we expect to significantly outperform our $175 million, three-year synergy target," said Bill Stone, Chairman and Chief Executive Officer of SS&C Technologies. "Our overall lower cost structure led to a substantial beat of our previous earnings guidance. We will update Q4 guidance on October 31st when we release our full Q3 earnings report."
ADC

Hot Stocks

16:08 EDT Agree Realty raises FY18 acquisition volume view to $425M-$475M - The Company's outlook for acquisition volume in 2018 is being increased to a range of $425M-$475M of high-quality retail net lease properties. The Company's acquisition guidance, which assumes continued growth in economic activity, moderate interest rate growth, positive business trends and other significant assumptions, is being increased from a previous range of $350M-$400M.
OMER

Hot Stocks

16:03 EDT Omeros treatment granted FDA orphan designation status - Omeros' treatment of Hematopoietic Stem-Cell Transplant-Associated Thrombotic Microangiopathy was granted orphan designation by the FDA, according to a post to the agency's website. Reference Link
LANC

Hot Stocks

16:03 EDT Lancaster Colony subsidiary acquired assets of Batnam Bagels for $34M - Lancaster Colony announced that its wholly-owned subsidiary, T. Marzetti Company, has acquired all the assets of Bantam Bagels. Bantam Bagels is a producer and marketer of frozen mini stuffed bagels and mini stuffed pancakes sold to both the retail and foodservice channels. The acquisition transaction closed on October 19. The acquisition was funded internally with cash on hand and is not significant to the financial position of Lancaster Colony Corporation. Annual net sales for Bantam Bagels are approximately $20M and the impact of the acquisition on Lancaster Colony's earnings per share is expected to be about neutral for the current fiscal year ending June 30, 2019. In addition to the base purchase price of $34M, which is subject to post-closing adjustments, the transaction also includes contingent consideration in the form of an additional earn-out payment that is tied to the future financial performance of the business. Other terms of the transaction are not disclosed.
LANC

Hot Stocks

16:03 EDT Lancaster Colony acquires Bantam Bagels for $34M - Lancaster Colony announced that its wholly-owned subsidiary, T. Marzetti Company, has acquired all the assets of Bantam Bagels, LLC. Bantam Bagels is a producer and marketer of frozen mini stuffed bagels and mini stuffed pancakes sold to both the retail and foodservice channels. The acquisition transaction closed on October 19, 2018. The acquisition was funded internally with cash on hand and is not significant to the financial position of Lancaster Colony Corporation. Annual net sales for Bantam Bagels are approximately $20 million and the impact of the acquisition on Lancaster Colony's earnings per share is expected to be about neutral for the current fiscal year ending June 30, 2019. In addition to the base purchase price of $34M, which is subject to post-closing adjustments, the transaction also includes contingent consideration in the form of an additional earn-out payment that is tied to the future financial performance of the business. Other terms of the transaction are not disclosed.
AMTD

Hot Stocks

16:03 EDT TD Ameritrade reports Q4 net new client assets roughly $24B - Reports Q4 average client trades per day of roughly 795,000, up 50% y/y.
MINI

Hot Stocks

16:01 EDT Mobile Mini names Kelly Williams as new COO - Mobile Mini announced the appointment of Kelly Williams as President & Chief Operating Officer. Mr. Williams was previously serving as Executive Vice President & Chief Operating Officer at Mobile Mini. Mr. Williams will now oversee global operations in both North America and the UK as well as the company's Supply Chain, Operational Excellence and Marketing responsibilities on a global basis. He will continue reporting to Erik Olsson, CEO of Mobile Mini.
PRSC

Hot Stocks

16:01 EDT Providence Service surges into close after report of private equity interest - Shares of Providence Service jumped heading into the close after Reuters said the provider of medical transportation services is exploring a sale after attracting interest from private equity firms. Providence Service is working with an investment bank as it negotiates with potential buyers, sources told Reuters.
SVU

Hot Stocks

15:57 EDT Supervalu trading resumes
PETX

Hot Stocks

15:42 EDT Aratana Therapeutics rises after reported to hire bank to explore alternatives - Shares of Aratana Therapeutics are up 62c, or 11.6%, to $5.98 after Dealreporter said that the company is working with Barclays as a financial advisor to explore its strategic alternatives. According to the report from the deal-focused news service, Aratana previously committed to activist investor Engaged Capital that it would appoint a board committee to conduct a strategic review by no later than July1 and the company has been following the cooperation agreement's timeline.
SCG

Hot Stocks

15:39 EDT SCANA trading resumes
LLY

Hot Stocks

15:32 EDT Eli Lilly announces 'positive' results for two Phase 3 studies of Taltz - Eli Lilly announced that the company will present positive findings from two Phase 3 studies, COAST-V and COAST-W, in adults with ankylosing spondylitis, or AS), at the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting on October 23. The analyses are part of a clinical development program that aims to evaluate Taltz across various populations of patients with AS. In both studies, Taltz demonstrated a statistically significant and clinically meaningful improvement in proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 over 16 weeks compared to placebo. ASAS40 represents at least a 40% improvement in disease signs and symptoms such as pain, inflammation and function. COAST-V is the first successful trial in AS to use ASAS40, a stringent clinical measure indicating a high degree of clinical improvement as the primary endpoint, compared to the standard endpoint of ASAS20. COAST-W is the first AS study to specifically focus on the difficult-to-treat population of patients who had an inadequate response to one or two tumor necrosis factor inhibitors or intolerance to a TNF inhibitor.
SCG D

Hot Stocks

15:27 EDT SCANA says SC judge indicated no final decision has been reached - SCANA issued the following statement: "SCANA is aware that last week the circuit court judge assigned to the customer class action in South Carolina provided instructions to counsel for the plaintiffs and the state that requested them to submit proposed orders to him. Those instructions directed the attorneys to include language in the proposed orders stating, among other things, that the Base Load Review Act violates the procedural due process provisions of the South Carolina Constitution. The proposed orders have been submitted to the judge by those attorneys. SCANA intends to provide the judge with comments to various portions of the proposed orders by Monday, October 29. The judge has indicated to the attorneys for the parties that no final decision has been reached at this time, and the aforementioned issues will remain unresolved until he signs an order in the matter."
NKTR...

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15:24 EDT Nektar Therapeutics plunges as Roche data seen as concern - Shares of Nektar Therapeutics (NKTR) are under pressure as H.C. Wainwright analyst Debjit Chattopadhyay tells investors Roche's (RHHBY) RO6875281, a fibroblast activation protein targeted interleukin-2 variant, is "off to a good start." ROCHE DATA SHOULD CONCERN NEKTAR BULLS: In a research note to investors, H.C. Wainwright's Chattopadhyay said he believes Roche's preliminary data of RO6875281, a fibroblast activation protein targeted interleukin-2 variant, should concern the bulls of Nektar Therapeutics. The 11% and 20% overall response rate for single agent RO6875281 in squamous cell head and neck cancer and melanoma is compelling, the analyst contended. Further, Chattopadhyay noted that Nektar's NKTR-214 had no monotherapy activity, and the early promise in combination with Opdivo "has faded potentially due to its limited PK profile." In addition, the analyst argued that the monotherapy activity with pegilodecakin, a pegylated IL-10 being developed by Eli Lily (LLY), further complicates the competitive landscape for NKTR-214. He believes the second generation of "not alpha" IL-2, which is poised to enter the clinic during 2019, could further "upend" NKTR-214 and might compel Nektar's partner Bristol-Myers Squibb (BMY) to "re-evaluate the aggressive development strategy that was outlined earlier this year." The analyst reiterated a Neutral rating and $54 price target on Nektar's shares. SHORT REPORT ON NEKTAR: Earlier this month, Plainview published a short report on Nektar Therapeutics saying that the stock has "zero value." In the report, Plainview argued that the "First rule of biotechnology investing: if a company withholds data from investors, that data is always bad." "Investors believe that NKTR-214 could have synergistic effects with checkpoint inhibitors and become a new universal cancer treatment. We disagree-the thesis and clinical data are nearly identical to the now-disproven IDO inhibitor story, and the notion that a failed monotherapy will add statistically significant value as part of a combination therapy has never worked in practice. In cancer research, the total efficacy of combination therapy is less than the sum of the parts, not more. This is especially true for IL-2 which-despite showing indisputable efficacy as monotherapy- failed to show benefit in any of the three controlled trials where it was tested as part of a combination therapy. [...] Nektar's stock plunged after ASCO 2018, where Nektar reported declining response rates in its RCC and melanoma treatment groups. Even more alarming was Nektar's decision to only disclose response rates for 31% (87/283) of dosed patients at ASCO 2018- an unprecedented level of data opacity and a stark contrast to the 95% (36/38) disclosed at SITC 2017," the report reads. PRICE ACTION: In afternoon trading, shares of Nektar Therapeutics have dropped almost 18% to $39.55.
SCG

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15:20 EDT SCANA trading halted, news pending
AJG

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15:10 EDT Arthur J. Gallagher acquires Richter International Consulting, terms undisclosed - Arthur J. Gallagher & Co. announced the acquisition of Issaquah, Washington-based Richter International Consulting. Terms of the transaction were not disclosed. Founded by Dave Richter in 2002, Richter International designs customized international benefits programs for multinational companies and nongovernmental organizations and their employees.
FDC

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15:03 EDT First Data to refinance revolving credit facility and certain other indebtedness - First Data announced that it is seeking to refinance its existing revolving credit facility maturing June 2020, its existing term loans due June 2020 and certain other existing indebtedness. As of the date of this press release, the arrangers of the Refinancing have informed First Data that they have received commitments in respect of a potential new revolving credit facility of over $1.25B and commitments in respect of a potential new term loan facility of over $4.75B. If consummated, the transaction is expected to be completed on or about October 26, 2018 to refinance the existing facilities due 2020 with a portion of the funding to be consummated later to refinance other existing indebtedness. The successful completion of these transactions is subject to market and other conditions and there can be no assurance that they can be completed on the terms contemplated or at all.
MRBK

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14:42 EDT Meridian Bank names Randy J. McGarry chief information officer - Randy J. McGarry has joined Meridian Bank as its chief information officer. McGarry served for six years as CIO for a NASDAQ listed bank holding company in Hatboro, Pennsylvania with assets exceeding $1.2B. "We are excited to welcome Randy to the executive team at Meridian," said Chris Annas, President and CEO of the Bank. "Randy strengthens our outstanding operations and IT team and further verifies the importance that great technology and process has at Meridian. His experience in building bank infrastructure and overseeing bank combinations will play a critical role in our continued growth."
AU

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14:34 EDT AngloGold says Kibali Gold Mine seen delivering record performance in Q3 - AngloGold Ashanti reports that the Kibali Gold Mine is expected to deliver a record performance for the third quarter, and is on track to exceed its guidance for the year, as the operation met or exceeded designed capacity on throughput, recovery and hoisting capacity. The mine, a joint venture with the Democratic Republic of Congo, AngloGold Ashanti, 45%, and Randgold Resources, 45% and operator, is trending to outperform its full-year production guidance of 730,000oz. The joint venture has also reached agreement with the DRC Ministry of Finance, for the return of outstanding value-added tax refunds. "This is an important, tier-one asset for the country at large, and for us, as we work to improve returns to our shareholders," AngloGold Ashanti CEO Kelvin Dushnisky said. "It's encouraging for us as investors, and for the future development of the DRC's mining industry, that Kibali is poised to start returning capital to those who funded the first large- scale, industrial gold mining project in one of the country's most remote areas."
BLMN

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14:20 EDT Bloomin' Brands says has had seven discussions with Barington since March 2017 - Bloomin' Brands, in respone to a letter from Barington Capital Group, stated: "The company notes that it regularly engages with shareholders on a wide range of matters to advance the common goal of enhancing shareholder value. Consistent with this philosophy, since March 2017, the company has had seven discussions with Barington to better understand its views and suggestions. The company looks forward to sharing its third quarter results next week and engaging with shareholders following the conference call." Jim Craigie, Lead Independent Director of the Board, added, "The Bloomin' Brands Board of Directors is actively engaged in overseeing the strategy of the Company. We fully support the management team and its successful ongoing efforts. The Company welcomes shareholder dialogue and any constructive input that may advance our goal of delivering superior returns for investors."
F

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14:04 EDT Ford expanding test of autonomous vehicles to Washington, D.C. - In an opinion editorial provided by Sherif Marakby, CEO, Ford Autonomous Vehicles, the executive stated: "Just like guiding a bill through Congress, establishing a self-driving vehicle business requires a lot of coordination. Not only do self-driving vehicles need to operate safely and reliably, but they also need to work in concert with the businesses, people and cities they serve. On top of all this, they must operate within an ecosystem that supports their operation and maintenance. As Ford's work in all those areas continues in Detroit, Pittsburgh and Miami, we are expanding to become the first company to test autonomous vehicles in Washington, D.C., according to the district, by establishing a self-driving vehicle business-a business that will be responsive to the needs of the city and its residents...The advent of self-driving vehicles promises a chance to make it more affordable and easier for people to get to jobs by filling gaps in access to public transportation, new ways to deliver food and other products, and more...That's why we'll be working with local officials in Washington, D.C., to ensure that we test our self-driving vehicles in all eight of the district's wards-and eventually operate business pilot programs in all eight wards as well-as we work toward deployment of a commercial service in 2021." Reference Link
FB

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13:42 EDT Oculus co-founder announces departure from Facebook - Brendan Iribe, who was CEO and co-founder of Oculus VR when Facebook bought the company in 2014, announced today his departure from the social media giant. Iribe was most recently the vice president of computer-tethered virtual reality. He said in a Twitter post, "What a ride! We made science fiction into reality and inspired a new industry in the process. Oculus was only possible because of such an extraordinary team and community. Thank you! Now, six years after we launched Oculus and Rift, I'm moving on to the next chapter!"
WFC

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13:34 EDT Wells Fargo 'pleased' to reach pact with NY Attorney General - Wells Fargo & Company issued a statement regarding an agreement with the Office of the Attorney General of the State of New York to resolve claims alleging certain misstatements and omissions in the company's disclosures related to sales practices matters. "We are pleased to reach this agreement," the bank said. "Wells Fargo did not admit liability, and we believe that putting this matter behind us is in the best interest of all of our stakeholders, including customers. The settlement costs have been previously accrued. We are making strong progress in our work to rebuild trust, and this represents another step forward. Over the past two years, we have made fundamental changes to retail sales practices, and the claims in this settlement relate to past product sales goals that were eliminated in 2016. We remain focused on transforming Wells Fargo into a better company for our customers and other stakeholders."
GILD GLPG

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13:20 EDT Gilead, Galapagos NV announce publication of trial results with filgotinib - Gilead Sciences (GILD) and Galapagos NV (GLPG) announced that detailed results from two clinical trials evaluating filgotinib, an investigational, selective JAK1 inhibitor, for the treatment of psoriatic arthritis and ankylosing spondylitis were both published in The Lancet. The publication of the Phase 2 EQUATOR data also coincides with a plenary session presentation at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting. Data from EQUATOR, a placebo-controlled trial of 131 adults with moderately to severely active psoriatic arthritis who had an inadequate response or were intolerant to at least one conventional disease-modifying anti-rheumatic drug, demonstrated the efficacy of filgotinib in this patient population. The study achieved its primary endpoint at Week 16, with 80 percent of patients on filgotinib 200mg once-daily achieving ACR20, compared with 33 percent on placebo. ACR50 and ACR70 responses at Week 16 were also significantly higher for filgotinib compared with placebo. These data were previously announced in May 2018. The study also found greater improvement in disease signs and symptoms for patients receiving filgotinib 200mg once-daily compared with placebo at Week 16, as measured by Minimal Disease Activity and the Psoriasis Area and Severity Index 75 percent improvement from baseline. The data showed greater improvement from baseline in the Health Assessment Questionnaire Disability Index for those receiving filgotinib compared with placebo. Safety-related outcomes were similar between the filgotinib and placebo arms of the study, including rates of treatment-emergent adverse events and infections and infestations. Two serious treatment-emergent adverse events were reported: one hip fracture in the placebo group and one case of fatal pneumonia in the filgotinib treatment group, which was the only serious infection and the only death in the study. No deep venous thrombosis, pulmonary embolism, malignancies, gastrointestinal perforations, opportunistic infections/active tuberculosis or cases of Herpes zoster were reported. In the Phase 2 TORTUGA study, adults with moderately to severely active ankylosing spondylitis who were treated with filgotinib 200mg once-daily achieved significantly greater improvements in AS Disease Activity Score, the primary endpoint, at Week 12. The mean change from baseline in ASDAS was -1.5 for patients treated with filgotinib versus -0.6 for those treated with placebo. ASAS20 and ASAS40 responses at Week 12 were also significantly higher for filgotinib compared with placebo. Adverse events were generally mild or moderate in severity and were reported in an equal proportion of patients in the filgotinib and placebo groups. Laboratory changes were consistent with those previously reported for filgotinib, and no new safety signals were observed in the study. There was one treatment-emergent serious adverse event of pneumonia reported for a patient receiving filgotinib who recovered after hospital-based antibiotic treatment. One patient with an inherited risk for thrombosis who was randomized to filgotinib experienced a non-serious deep venous thrombosis after completing the course of study drug. No deaths, malignancies, hepatic events, gastrointestinal perforations, opportunistic infections/active tuberculosis, or cases of Herpes zoster were reported.
WFC

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13:17 EDT NY Attorney General announces $65M settlement with Wells Fargo - New York Attorney General Barbara D. Underwood announced that Wells Fargo & Company will pay a $65M penalty following the Attorney General's investigation into the bank's fraudulent statements to investors in connection with its "cross-sell" business model, related sales practices, and the bank's publicly reported cross-sell metrics. "The misconduct at Wells Fargo was widespread across the bank and at every level of management - impacting both customers and investors who were misled," said Attorney General Underwood. The Attorney General's office is also continuing its investigation of Wells Fargo in connection with its illegal business practices of opening millions of unauthorized accounts and enrolling consumers in services without their knowledge or consent. This settlement has no impact on that ongoing investigation and other pending investigations of Wells Fargo.
VIAB

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13:01 EDT Viacom's MTV names Lars Silberbauer as SVP for MTV Digital Studios - MTV has tapped Lars Silberbauer, a former LEGO executive, as Senior Vice President for Viacom's MTV Digital Studios. In the newly established role, Silberbauer will oversee creative, development, and production for the network's digital originals, and lead MTV's digital brand social channels, including "Cribs," "TRL" and more. Silberbauer will relocate from London to New York and begin on November 1st, reporting into Jacqueline Parkes, CMO and EVP, Digital Studios, MTV, VH1 and Logo Group and Kelly Day, President, Viacom Digital Studios.
CZR

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12:57 EDT Canyon Partners 'has faith in the ability' of Caesars management - Canyon Partners earlier today issued a statement in response to recent media reports that it says "have no basis in fact and as to which Canyon Partners was not provided an opportunity to comment in advance of publication to refute anonymous sources." It said, "Canyon has not leaked any confidential information relating to Caesars to anyone at any time. It is reckless for anyone to report otherwise. Canyon has faith in the ability of the Caesars management team and board of directors to operate the business, to evaluate any reported transactions and to continue to maximize value for all shareholders."
PII

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12:49 EDT Polaris Industries considering taking more aggressive actions to offset tariffs - Polaris Industries, on its conference call earlier this morning, said that now believes it is unlikely there will be a short or medium-term agreement with China on trade issues and, with substantial impact of the 301 list looming, it is considering taking more aggressive actions. Polaris said it "fully expects" suppliers to absorb their fair share of tariffs. The company said the direct impact of the steel/aluminum tariffs is not substantial "because we predominantly buy these metals from U.S. suppliers," adding that these suppliers did use the opportunity to raise prices. The company said it has partially offset these increases through adjusting its own prices and negotiating with suppliers. Shares of Polaris Industries are up 2.6% to $93.09 in afternoon trading.
EDRY

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12:23 EDT Fred H. Brenner Estate reports 7.9% passive stake in EuroDry
SJI

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12:19 EDT South Jersey Industries trading resumes
SJI

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12:11 EDT South Jersey Industries tightens targeted payout ratio to 55%-65% - South Jersey Industries tightened its targeted payout ratio to 55%-65% of consolidate SJI earnings from previous ratio of 55%-70%. "We expect to achieve the midpoint of our targeted payout ratio in the latter years of plan horizon," the company stated in slides.
SJI

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12:04 EDT South Jersey Industries sees capital expenditures of $2.5B-$2.6B over five years - From 2018-2022, South Jersey Industries is targeting $2.5B-$2.6B in capital expenditures, which it notes in presentation slides "is the largest growth and maintenance capital deployment in our company's history." In the investor conference slides, the company noted that "more than 98% of total spending [will be] on regulated utility and FERC-regulated pipeline investments."
ORCL

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12:02 EDT Oracle launches new data cloud solution for B2B marketers - Oracle Data Cloud today launched a new SMB data solution that helps B2B marketers reach over 115 million IDs at more than 1.5 million small and mid-sized businesses, SMBs, with effective digital campaigns. The new solution enables account-based marketing,ABM, for sales outreach to contacts at small and mid-size businesses across 48 industry and sub-industry segments, offering similar outreach tools to those used by larger organizations. "Most data and tools for digital B2B marketing have focused on large companies while ignoring the millions of smaller companies who make up the vast majority of US businesses," said Niraj Deo, vice president, product & data Strategy, Oracle Data Cloud. "This SMB data solution levels the playing field for B2B marketers so they can identify, reach, and manage their sales and marketing programs for both large organizations and the smaller businesses who can drive their growth. By combining their own CRM data with Oracle's syndicated and custom segments, B2B marketers can use advanced account-based marketing capabilities for this massive, but underserved, universe of SMBs." Using Oracle Data Cloud's SMB solution, B2B marketers can build digital audiences to match their marketing goals and business needs, based on criteria ranging from number of employees to financial risk profiles, growth patterns, accepted payments, ecommerce capabilities, and past purchases.
AEE

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12:02 EDT EDF Renewables, Ameren Missouri enter agreement for Missouri wind project - EDF Renewables North America and Ameren Missouri, a subsidiary of Ameren Corporation, announced an agreement by which Ameren will acquire, after construction, the 157 megawatts Brickyard Hill wind project. The facility, developed by EDF Renewables and located in Atchison County, is expected to create more than 280 jobs at peak construction along with millions of dollars injected into the local economy. When operational in 2020, energy produced by the wind facility will power an estimated 47,000 homes. This new generation will help Ameren Missouri meet its goal of reducing carbon emissions 80% by 2050, based on 2005 levels. The agreement is subject to conditions precedent, including approval from the Missouri Public Service Commission and obtaining a timely and acceptable transmission interconnection agreement from the Midcontinent Independent System Operator.
OSTK...

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12:02 EDT Overstock's blockchain subsidiary invests $6M in Minds, Inc. - Minds, Inc., a crypto social network, announced a $6M Series A investment from Medici Ventures, the wholly-owned blockchain subsidiary of Overstock.com, Inc., advancing blockchain technologies to democratize capital, eliminate middlemen, and re-humanize commerce. Overstock.com founder and CEO Patrick M. Byrne, a vocal advocate for blockchain, user rights, and free speech, will be joining the Minds board of directors.
HCLP

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12:00 EDT Hi-Crush Partners falls -7.2% - Hi-Crush Partners is down -7.2%, or -63c to $8.12.
CGC

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12:00 EDT Canopy Growth falls -9.1% - Canopy Growth is down -9.1%, or -$4.25 to $42.60.
PHG

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12:00 EDT Philips falls -9.1% - Philips is down -9.1%, or -$3.64 to $36.31.
PZN

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12:00 EDT Pzena Investment rises 7.0% - Pzena Investment is up 7.0%, or 67c to $10.20.
BKE

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12:00 EDT The Buckle rises 8.1% - The Buckle is up 8.1%, or $1.49 to $19.78.
CCM

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12:00 EDT Concord Medical rises 9.4% - Concord Medical is up 9.4%, or 27c to $3.14.
SJI

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11:52 EDT South Jersey Industries trading halted, news pending
TMP

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11:14 EDT Tompkins Financial appoints Steven Cribbs to senior leadership team - Tompkins Financial announced that Steven Cribbs, SVP, chief risk officer, was appointed to the Senior Leadership Team of the company by its Board of Directors. The Senior Leadership Team is responsible for setting the overall direction of the company and providing executive leadership. Steve joined Tompkins Financial in June of this year. He is responsible for overseeing compliance, audit, information security, and enterprise risk management functions at Tompkins Financial.
MSFT

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11:02 EDT Eastside Health Network, Premera collaborate with Microsoft on new health plan - A collaboration among Microsoft, Eastside Health Network and Premera Blue Cross will provide a new custom health plan option for King and Snohomish County-based Microsoft employees beginning 2019. The new option called The Health Connect Plan, combines EHN's clinically integrated provider network with Premera's 85 years of experience providing health plans, to offer a better customer experience while ensuring patients receive the care they need. Microsoft's substantial regional footprint in the Puget Sound area and innovative approach to technology aligns with EHN and Premera's focus on providing better more integrated care. The plan also will include Allegro Pediatrics, a provider network offering pediatric care for over 50 years, and the Living Well Health Center, Microsoft's onsite clinic. Microsoft employees working with a Health Connect network provider will experience personalized and coordinated care and have more cost predictability when it comes to managing their health.
UNP...

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10:38 EDT Analyst says sell Union Pacific, Genesee & Wyoming on slowing demand - In a research note this morning, Morgan Stanley analyst Ravi Shanker told investors that it was time to get cautious on freight transportation stocks as he sees downside risk to consensus in 2019 across virtually the entire group driven by slowing demand fundamentals. In conjunction with his change in the sector rating, the analyst downgraded Union Pacific (UNP) and Genesee & Wyoming (GWR) to Underweight and cut Old Dominion (ODFL) to Equal Weight. DOWNGRADING INDUSTRY VIEW TO CAUTIOUS: Moving his industry view to cautious, Morgan Stanley's Shanker argued that he sees downside risk to consensus in 2019 across virtually the entire freight transportation group driven by slowing demand fundamentals. Yet, valuations remain elevated across most of the group, he said. The analyst trimmed his estimates across the board by about 2%, on average, for FY19-21. However, Shanker noted that he is not calling for a macro recession in 2019. Instead, he is concerned that 2019 could be similar to 2015-2016, when the transportation complex went through a freight recession even as the overall economy held up. SELL UNION PACIFIC, GENESEE & WYOMING: Morgan Stanley's Shanker downgraded Union Pacific to Underweight from Equal Weight, saying that while he has always viewed it as "the most defensive" among the U.S. rails given its long LoH, PRB coal exposure, and relatively low IM risk, he now sees risk as too high if the cycle turns. Specifically, Shanker pointed out that his firm's coal team has turned more bearish on domestic coal demand in 2019, and added that the frac sand risk that he highlighted last year looks like it would materialize in early 2019. Union Pacific's struggles to grow pricing when the market is firing on all cylinders raises concern on what pricing net of inflation will be like next year given the increase in rail inflation expectations, he contended. Additionally, the analyst believes the company's PSR implementation carries "significant execution risk" and the goal appears to be a stretch relative to expectations. Meanwhile, Shanker also downgraded Genesee & Wyoming to Underweight from Equal Weight arguing that if the truckload market loosens up driven by decelerating demand and industrial end markets weaken from here, Genesee will be the rail "most exposed" to topline headwinds. Noting that about 20% of the company's operating income is from Australia and U.K./Europe, the analyst pointed out that Genesee & Wyoming's Australia business faces risk of decelerating growth in China and the U.K./Europe business faces risk of Brexit uncertainty. Moreover, Genesee & Wyoming is also the most levered rail, making it exposed to rising interest rates, he contended. MOVING TO SIDELINES ON OLD DOMINION: Despite the recent selloff in the stock and it remaining his favorite less than truckload name, Morgan Stanley's Shanker downgraded Old Dominion to Equal Weight from Overweight. The analyst noted that Old Dominion's absolute and relative tonnage growth turned as scheduled three months ago but the stock did not reciprocate as it typically does. It now appears that the stock is catching up but has "a ways to go to close the relative valuation gap to the truckloads," Shanker added. While the analyst thinks that if macro does start to slow, LTL stocks will feel it, he still believes Old Dominion will hold up better than peers given its defensive nature, superior margin profile and relatively bearish investor positioning. PRICE ACTION: In morning trading, shares of Union Pacific have dropped almost 1.5% to $146.57, while Genesee & Wyoming's stock has slipped about 3% to $79.02. Also lower, shares of Old Dominion slid over 1% to $130.27.
USX

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10:38 EDT U.S. Xpress appoints Justin Harness Chief Marketing Officer - U.S. Xpress Enterprises announced the promotion of Justin Harness from senior VP of Dedicated Operations to Chief Marketing Officer of U.S. Xpress. Harness began his career with U.S. Xpress in 2002 as a Fleet Manager trainee and worked his way up the ranks through multiple departments in roles ranging from Director of Customer Service to Regional VP of Over-the-Road Operations.
RHHBY

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10:34 EDT Roche reports Phase 3 study of Alecensa met primary endpoint - Roche will today announce results from the phase 3 ALESIA study, showing that Alecensa met its primary endpoint of investigator-assessed progression-free survival. Alecensa significantly reduced the risk of disease worsening or death by 78%, compared to crizotinib, when given as an initial monotherapy treatment in Asian patients with anaplastic lymphoma kinase-positive advanced or metastatic non-small cell lung cancer. Median PFS reported by the investigators was not yet reached in patients who received Alecensa versus 11.1 months in those who received crizotinib. The safety profile of Alecensa was consistent with that observed in previous studies. "The ALESIA study supports the use of Alecensa as the standard of care for newly diagnosed advanced or metastatic ALK-positive lung cancer across multiple populations. Alecensa has received rapid regulatory approvals for first-line treatment in 65 countries to date, including in China," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development.
PX...

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10:32 EDT Praxair expects Linde transaction to close on October 31 - Praxair (PX) announced that the final closing conditions for the merger of equals between Praxair and Linde AG (LNEGY) were satisfied after the European Commission approved the buyer of Praxair's divestment business in Europe and the Federal Trade Commission provided merger clearance of the business combination in the United States. The parties expect the transaction to close on October 31, 2018. Under the terms of an agreement with the FTC, neither Linde AG nor Praxair will integrate any of their commercial operations until certain U.S. based assets are divested. The new Linde plc shares are expected to start trading on the New York Stock Exchange and the Frankfurt Stock Exchange under the ticker symbol "LIN". Trading in shares of Praxair's common stock is expected to be suspended on the NYSE as of close of business, New York time, on October 30, 2018, and Praxair's common stock is expected to be delisted from the NYSE.
MRK

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10:31 EDT Merck says Keytruda imrpoved OS vs. SoC in KEYNOTE-048 trial - Merck announced the first presentation of interim data from the pivotal Phase 3 KEYNOTE-048 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, as both monotherapy and in combination with chemotherapy, for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma. These interim results are being presented today during the Presidential Symposium at the ESMO 2018 Congress and are included in the official Press Program. Interim data from KEYNOTE-048 showed KEYTRUDA monotherapy improved overall survival, a primary endpoint of the study, by 39 percent in patients whose tumors expressed PD-L1 with Combined Positive Score greater than or equal to20, and by 22 percent in patients with CPSgreater than or equal to1, compared to the EXTREME regimen, the current standard of care. In addition, KEYTRUDA in combination with chemotherapy demonstrated improved OS compared to the EXTREME regimen by 23 percent, regardless of PD-L1 expression. At the final analysis, superiority for OS will be evaluated for KEYTRUDA monotherapy in the total population and KEYTRUDA combination in patients whose tumors express PD-L1 at CPSgreater than or equal to20 and CPSgreater than or equal to1; at this interim analysis, based upon the prespecified testing algorithm, non-inferiority for KEYTRUDA monotherapy in the total population was demonstrated and statistical significance was not achieved for the KEYTRUDA combination in the subset of patients whose tumors expressed PD-L1 at CPS greater than or equal to20 or greater than or equal to1. Additionally, at this time point there was no difference in progression-free-survival, a dual primary endpoint of the study, in any of the groups studied. There were no new safety concerns identified with the use of KEYTRUDA in KEYNOTE-048.
AMZN...

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10:28 EDT Strategy Analytics: Amazon Echo has 23% share of smart speakers in use - According to a major new consumer survey, the most popular smart speaker model in the US is the Amazon Echo (AMZN), which accounts for 23% of all smart speakers in use. Including all its models, Amazon accounts for 63% of smart speakers in use, while Google (GOOG, GOOGL) accounts for 17% and Apple (AAPL) 4%. These findings have been published by Strategy Analytics in its report "Smart Speaker User Survey - US Results". The research also found that there is plenty of opportunity for other smart speaker brands: when asked to name one brand they would choose for their next smart speaker, 54% of users chose either Amazon, Google or Apple, leaving nearly half the market open to competitors. Bose, Samsung and Sonos are the most preferred alternatives to the "big three". The online survey interviewed 1011 users of smart speakers in the US in July/August 2018. The survey also found that 88% of smart speaker homes own at least one Amazon smart speaker, and 31% own at least one Google smart speaker, indicating that many homes are happy to use different voice assistant platforms.
KMB

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10:17 EDT Kimberly-Clark says making 'good' progress on restructuring program
KMB

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10:17 EDT Kimberly-Clark says 'not satisified with performance right now in China'
UTX EADSY

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10:16 EDT Pratt & Whitney GTF engines selected by Aegean Airlines - Pratt & Whitney, a division of United Technologies Corp. (UTX), announced that Aegean Airlines has selected the Pratt & Whitney GTF engine to power up to 62 Airbus (EADSY) A320neo family aircraft: 30 firm, 12 option, and up to 20 leased aircraft. Pratt & Whitney will also provide the airline with engine maintenance through a long-term EngineWise Comprehensive service agreement.
KMB

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10:04 EDT Kimberly-Clark says CEO succession a 'carefully planned, natural transition' - Sees FY19 adjusted effective tax rate back to 23%-26% range. Sees FY dividends and share repurchases of approximately $2.2B, in line with initial target of $2.1B-$2.3B. Says environment is "difficult," with depreciating currencies adding to continued significant commodity inflation. Says realizing higher selling prices will be "important" next year, recent commodity forecasts and forward currency rates imply significant headwinds again in 2019. Says commodities and currencies expected to negatively impact 2018 adjusted operating profit by slightly more than 20%-25% range assumed in July. Says CEO succession a "carefully planned, natural transition." Comments taken from the Q3 earnings conference call. Kimberly Clark is down 1.2% to $108.94 in morning trading.
JNJ

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10:01 EDT J&J says tetravalent 'significantly enhanced' HIV immune responses - Johnson & Johnson announced the primary analysis of immune response data for a tetravalent mosaic-based preventive vaccine against HIV-1 infection in development at its Janssen Pharmaceutical unit. In the early-stage, Phase 1/2a Traverse study among HIV-negative volunteers, a vaccine regimen including a tetravalent mosaic viral vector was compared to a regimen containing a trivalent mosaic vector. At 28 weeks, the tetravalent mosaic-based vaccine was well tolerated and "significantly enhanced" the breadth of immune responses to different HIV-1 strains compared to the trivalent version, J&J said in a statement. These Phase 1/2a data will be shared this week at the 2018 HIV Research for Prevention Conference in Madrid, Spain. The tetravalent vaccine is "now in large-scale efficacy testing," the company said. Reference Link
UGAZ

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09:47 EDT VelocityShares 3x Long Natural Gas ETN falls -6.9% - VelocityShares 3x Long Natural Gas ETN is down -6.9%, or -$6.05 to $81.97.
PHG

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09:47 EDT Philips falls -7.9% - Philips is down -7.9%, or -$3.14 to $36.81.
LII

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09:47 EDT Lennox falls -6.8% - Lennox is down -6.8%, or -$13.20 to $179.92.
JEC

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09:47 EDT Jacobs Engineering rises 7.1% - Jacobs Engineering is up 7.1%, or $5.13 to $77.41.
TAL

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09:47 EDT TAL Education rises 7.3% - TAL Education is up 7.3%, or $1.71 to $25.21.
BEDU

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09:47 EDT Bright Scholar rises 10.1% - Bright Scholar is up 10.1%, or $1.03 to $11.20.
MCK

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09:46 EDT McKesson relaunches life sciences business as McKesson Life Sciences - McKesson Corporation announced that it has relaunched its biopharmaceutical services business under its U.S. Pharmaceutical and Specialty Health business unit as McKesson Life Sciences. "McKesson Life Sciences is the culmination of a purposeful evolution that aligns business assets, technology and innovations through the lens of its life sciences partners," the company said.
SMCI...

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09:40 EDT Super Micro denies malicious chip report, undertaking 'complicated' review - In a regulatory filing, Super Micro Computer (SMCI) said that on October 18, the company began sending letters to its customers, refuting allegations in a recent article that a malicious hardware chip was implanted during the manufacturing process of the company's motherboards. In the letters, Super Micro says "We are confident that a recent article, alleging a malicious hardware chip was implanted during the manufacturing process of our motherboards, is wrong. From everything we know and have seen, no malicious hardware chip has been implanted during the manufacturing of our motherboards. We trust you appreciate the difficulty of proving that something did not happen, even though the reporters have produced no affected motherboard or any such malicious hardware chip. As we have said firmly, no one has shown us a motherboard containing any unauthorized hardware chip, we are not aware of any such unauthorized chip, and no government agency has alerted us to the existence of any unauthorized chip. Despite the lack of any proof that a malicious hardware chip exists, we are undertaking a complicated and time-consuming review to further address the article. In the meantime, I want to assure you that Supermicro's design, manufacturing and quality processes are designed to ensure we provide high-performing, safe, reliable, and secure hardware to all our customers. We are a customer-focused, engineering-led culture, so we test our products at every step along the way. We check every board, we check every layer of every board, and we check the board's design visually and functionally, throughout the entire manufacturing process. Every board we manufacture has Supermicro oversight, including multiple layers of testing, from design to delivery. Specifically, our process requires the inspection of the layout and components of every product at the beginning and end of each stage of manufacturing and assembly. Our employees are on site with our assembly contractors throughout the process. These inspections include several automated optical inspections, visual inspections, and other functional inspections. We also periodically employ spot checks and x-ray scans of our motherboards along with regular audits of our contract manufacturers. Our test processes at every step are not only designed to check functionality, but also to check for the integrity and composition of our designs and to alert us to any discrepancies in the base design... For these reasons, we are confident that these allegations are wrong. In addition, experts across the ecosystem, including FBI Director Christopher Wray, NSA Senior Cybersecurity Advisor Rob Joyce, Director of National Intelligence Dan Coats, the Department of Homeland Security, the UK's GCHQ and even an expert quoted in the article itself, have questioned these allegations. Finally, Apple (AAPL) and Amazon (AMZN) have issued strong statements denying the claims."
K

Hot Stocks

09:38 EDT Kellogg to restart shipments of Honey Smacks cereal after salmonella scare - Kellogg will begin rolling back Honey Smacks cereal to U.S. shelves next month in limited quantities. The brand is also releasing the cereal with a simpler, updated recipe. In June, Kellogg said it was recalling about 1.3M cases of the cereal due to the potential for salmonella contamination.
HAS

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09:36 EDT Hasbro says it recaptured one third of Toys "R" Us revenues in U.S.,Canada - Says will open Midwest warehouse. Says it expects to return to growth in 2019. Says European margin was worse than expected. Says had more closeouts than expected. Says this is a transition year. Says is aggressively working to clear European inventory by year end. Says is well positioned to meet retailers demand this holiday season. Comments taken from Q3 earnings conference call.
UMPQ

Hot Stocks

09:33 EDT Kony acquires innovation subsidiary of Umpqua Holdings, terms not disclosed - Kony and Umpqua Holdings Corporation announced they have signed a definitive agreement for Kony to purchase the assets of Pivotus, the innovation subsidiary of Umpqua Holdings Corporation. Terms of the transaction were not disclosed. In acquiring Pivotus, Kony adds expertise and capabilities to enhance its Kony DBX portfolio of digital banking applications and platform for customers worldwide. It will also collaborate with Umpqua to continue developing the Engage platform Pivotus introduced earlier this year, which enables financial institutions to deliver a unique, more human customer experience in a digital banking environment. Pivotus will become part of the Kony DBX business and the Pivotus Engage solution will be renamed Kony DBX Engage. Kony DBX represents a major advancement to help financial institutions deliver frictionless digital experiences to customers across every point of interaction. Kony is the first vendor to provide pre-built, native and web apps along with a purpose-built digital banking platform for financial institutions. The Kony DBX platform builds on Kony's digital expertise in multiple industries, with advanced technology solutions supported by an expansive partner network.
DGX

Hot Stocks

09:31 EDT Quest Diagnostics acquires certain assets of Hurley Medical Center - Quest Diagnostics announced it has acquired certain assets of the outreach laboratory services operation of Hurley Medical Center, a leading regional provider of healthcare services. Patients and providers in central Michigan will have access to Quest's broader range of diagnostic services, a larger network of patient service centers, and access to unique tools, such as the company's Quanum suite of healthcare information technologies and data analytics. Financial terms were not disclosed.
RDHL

Hot Stocks

09:28 EDT RedHill Biopharma presents data showing MAP US study met primary endpoint - RedHill Biopharma reported additional positive data from the MAP US study, its first Phase III study of RHB-104 in the treatment of Crohn's disease. An abstract discussing the study's top-line results, 'A Phase III Randomized, Double Blind, Placebo-Controlled, Multicenter, Parallel Group Study To Assess The Efficacy And Safety Of Add-On Fixed-Dose Anti-Mycobacterial Therapy In Moderately To Severely Active Crohn's Disease' was presented as a late-breaking abstract today at the United European Gastroenterology Week by Dr. David Y. Graham, M.D., Professor of Medicine, Molecular Virology and Microbiology at Baylor College of Medicine, Houston and Lead Investigator of the MAP US study. MAP US is a randomized, double-blind, placebo-controlled Phase III study of RHB-104. The study enrolled 331 subjects with moderately to severely active Crohn's disease1 at over 100 investigative sites in the U.S, Europe, Australia, New Zealand and Israel. Subjects were randomized 1:1 to receive orally-administered RHB-104 or placebo as an add-on therapy to baseline standard-of-care medications, which included 5-ASAs, corticosteroids, immunomodulators and anti-TNF agents. The MAP US study successfully met its primary endpoint and key secondary endpoints with meaningful and statistically significant treatment effects, including the primary endpoint of clinical remission at week 26 and key secondary and other efficacy endpoints of clinical response3 at week 26, early clinical remission at week 16, clinical remission at weeks 16 and 52 and durable clinical remission on all visits, weeks 16 through 52. These previously reported outcomes4 were further enhanced when stratified for concomitant anti-TNF agent use as prospectively specified in the statistical analysis plan. The data was provided to RedHill by an independent third party CRO following an independent analysis and remains subject to completion of the Clinical Study Report.
CLSN

Hot Stocks

09:25 EDT Celsion announces GEN-1 overview published in oncology journal - Celsio announced that a program overview of the company's novel, immunotherapy agent GEN-1 was published in the peer-reviewed journal, Future Oncology. The article is co-authored by Premal Thaker and principal investigator in Celsion's GEN-1 development program. The publication outlines the DNA plasmid, gene-based concept and the key attributes supporting GEN-1's mechanism of action characterized by local and persistent delivery of IL-12 and modulation of tumor microenvironment favoring immune stimulation. GEN-1 is an investigational immunotherapy designed for the localized treatment of ovarian cancer as an adjuvant to standard of care chemotherapy treatment. GEN-1's ability to deliver IL-12 locally in a persistent manner to alter tumor microenvironment in favor of immune stimulation may have applications in tumor immunotherapy based on IL-12's proven ability to activate both innate and adaptive immunities. Formulated using Celsion's proprietary TheraPlas platform technology, the GEN-1 DNA plasmid is incorporated into a non-viral nanoparticle delivery system. Administered locally, the TheraPlas system protects the DNA plasmid while enabling cellular uptake. This novel approach then results in persistent, local, cellular production and secretion of the IL-12 protein at the cancer site.
BRO

Hot Stocks

09:21 EDT Brown & Brown to acquire Hays Companies insurance operations - Brown & Brown has entered into an agreement to acquire the assets of the Hays Companies insurance operations. The transaction is expected to close in November, subject to certain closing conditions. Jim Hays formed the Hays Companies in 1994. Since formation, Hays along with many others, have grown Hays Companies to annualized revenue of approximately $200M. Headquartered in Minneapolis, Hays Companies is comprised of over 700 risk management and employee benefits professionals in 32 locations across 21 states. The Hays Companies focuses on risk management, commercial insurance, employee benefits, consulting services, specialty programs and private client services. Hays Companies will operate as a region inside Brown & Brown Retail. The operations will continue to be led by Jim Hays, as CEO of the Hays Companies, and Mike Egan will continue to serve as president/COO. Following completion of the transaction, Jim will join Brown & Brown as vice chairman and will serve on the board. Brown & Brown will provide an overview of the transaction in its Q3 earnings release.
PLAG

Hot Stocks

09:16 EDT Planet Green Holdings comments on unusual market activity - Planet Green Holdings announced that in view of the unusual market activity in the company's common stock on October 19, the NYSE American has contacted the company in accordance with its usual practice. The company is not aware of any reason for the activity and stated that its policy is not to speculate on unusual market activity.
LNEGY...

Hot Stocks

09:12 EDT FTC approves Praxair, Linde merger with conditions - The Federal Trade Commission will require industrial gas suppliers Praxair (PX) and Linde AG (LNEGY) to divest assets in nine industrial gases product markets in numerous geographic markets in the United States, as part of a settlement that resolves charges that their proposed $80 billion merger likely would be anticompetitive. The parties will divest to Messer Group GmbH, or an alternative Commission-approved buyer, Linde's U.S. bulk liquid oxygen, nitrogen, and argon business, including all thirty-two of its merchant air separation units, together with sixteen of Linde's U.S. carbon dioxide facilities, source contracts equal to all of Praxair's helium source contract volume, Linde's U.S. excimer laser gas business, and Linde's North American liquid hydrogen production facility, along with all related equipment, intellectual property, contracts, and other assets. Messer will form a joint venture with CVC Capital Partners to finance its acquisition of the divested assets. Messer will maintain majority control of the joint venture. The parties will divest to Matheson Tri-Gas, Inc., or an alternative Commission-approved buyer, five of Linde's HyCO facilities outside the Gulf Coast region, along with Linde's hydrogen pipeline in the Gulf Coast, intellectual property, customer contracts, and other assets The parties will also divest two of Linde's HyCO plants back to their respective customers or to other Commission-approved buyers. The parties will divest Linde's Clear Lake, Texas plant to Celanese Corporation (CE) and Linde's La Porte, Texas plant to LyondellBasell Industries N.V. (LYB), or to other Commission-approved buyers. Praxair and Linde have agreed to divest the required facilities within four months of signing the Agreement Containing Consent Orders. Until the divestitures to Messer and Matheson are accomplished, Linde and Praxair are prohibited from integrating their operations anywhere in the world.
ARII...

Hot Stocks

09:11 EDT Fly Intel: Pre-market Movers - HIGHER: American Railcar (ARII), up 50% after announcing that it has entered into a definitive agreement to merge with a wholly-owned subsidiary of ITE Rail Fund at a price of $70 per share... Jetpay (JTPY), up 134% after NCR Corporation (NCR) announced a definitive agreement to acquire the company in a cash tender offer of $5.05 per JetPay share... CollPlant (CLGN), up 58% after the company and United Therapeutics (UTHR) announced that they have entered into a license, development and commercialization agreement for 3D bioprinted lung transplants... Dynavax (DVAX), up 22% after announcing its SD-101, Keytruda combo still shows 70% ORR in advanced melanoma. DOWN AFTER EARNINGS: Halliburton (HAL), down 2%... Hasbro (HAS), down 5%. ALSO LOWER: Mirati Therapeutics (MRTX), down 25% after presenting updated data on sitravatinib with Opdivo study... Aveo (AVEO), down 4% after announcing updated interim results from Phase 2 TiNivo study... Caesar's (CZR), down 3% after NY Post reports the company will reject Golden Nugget's merger offer... Axon (AAXN), down 4% after New York Times reports The New York Police Department is removing roughly 3,000 body cameras from use after one of the devices worn by a Staten Island officer exploded into flames... Bristol-Myers (BMY), down 3% after the company announced a slowing of the regulatory process in the U.S. and E.U. for the ongoing review of its applications for an indication in metastatic first-line non-small cell lung cancer with Opdivo plus low-dose Yervoy in patients with tumor mutational burden. Also, Citi analyst Andrew Baum downgraded Bristol-Myers to Neutral from Buy citing competition from Merck's (MRK) Keytruda.
UNFI SVU

Hot Stocks

09:11 EDT United Natural Foods completes acquisition of Supervalu - United Natural Foods (UNFI) announced it has completed the previously announced acquisition of SUPERVALU (SVU) for $32.50 per share in cash, or approximately $2.9B, including the assumption of outstanding debt and liabilities. The completion follows the satisfaction of all closing conditions including approval of the transaction by SUPERVALU shareholders and receipt of all necessary antitrust approvals. In connection with the completion of the transaction, SUPERVALU's common stock will cease trading prior to market open on October 22, 2018 and will be delisted from the New York Stock Exchange.
DECK

Hot Stocks

09:10 EDT Deckers Brands division Hoka One One partners with Engineered Garments - Deckers Brands' Hoka One One division has announced its second partnership with American- and Japanese-inspired fashion label Engineered Garments to create a footwear collaboration featuring the Tor Ultra Low style for this Fall 2018. The unisex style will be available at select Engineered Garments' retail stores in New York and Tokyo, as well as on Hoka's U.S., Japanese and European websites starting October 22. The collaboration for HOKA and Engineered Garments features the Tor Ultra Low, a low-cut edition of the brand's best-selling Tor Ultra Hi Waterproof hiking shoe. The shoe retails for $200.
CRAY

Hot Stocks

09:10 EDT Cray, Stradigi AI announce partnership to offer AI implementation solutions - Cray and Stradigi AI announced a strategic partnership to offer AI implementation solutions combining Stradigi AI's specialized data science with Cray's supercomputing and advanced technologies. Under the partnership, Cray will bundle Stradigi AI's domain with its Cray Accel AI starter kit to deliver tailored solutions for proofs-of-concept to deployment at scale. Stradigi AI's team is able to develop configurable, scalable and secure solutions that can solve real-life business problems using artificial intelligence. Stradigi AI's global clients are made up of enterprises spanning a wide-range of industries. Their strategic and research partnerships include agreements with Cossette, IVADO and the Vector Institute.
ADBE

Hot Stocks

09:08 EDT Adobe achieves global gender pay parity - Adobe announced it has delivered on its commitment to pay parity between women and men globally across nearly 40 countries. This is a critical milestone in Adobe's ongoing commitment to providing employees with a workplace that is inclusive, innovative and exceptional. Adobe defines pay parity as ensuring that employees in the same job and location are paid fairly to one another, regardless of their gender or ethnicity. As a core element of its gender pay parity initiative, the company analyzed its employees' pay within job families and location, and then made a small number of adjustments to employees' pay based on that review. These global pay adjustments, including those previously made in the United States and India, impacted less than five percent of Adobe employees and less than 0.2 percent of global payroll costs.
TSS HBI

Hot Stocks

09:07 EDT TSYS appoints Joia Johnson to its board of directors - TSYS (TSS) announced the election of Joia Johnson, chief administrative officer, general counsel and corporate secretary for Hanesbrands (HBI), to its Board of Directors. Johnson was also appointed to the compensation committee of TSYS' Board of Directors. Her election brings the number of TSYS directors to 13.
DHX CROX

Hot Stocks

09:06 EDT DHI Group names Michelle Marian as Chief Marketing Officer - DHI Group (DHX) announced it has hired Michelle Marian as its new Chief Marketing Officer. Based in Denver, Marian will lead DHI's global marketing organization, with responsibility for the company's digital marketing strategy, demand generation and branding for its three services: Dice, eFinancialCareers and ClearanceJobs. Marian most recently managed Global Digital Marketing at Crocs (CROX).
SPKE

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09:06 EDT Spark Energy to acquire 60,000 RCEs from retail energy provider - Spark Energy announced that the company has signed a definitive agreement to acquire approximately 60,000 residential customer equivalents, or RCEs, from a retail energy provider in the Mid-Atlantic and Midwest regions.
HK

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09:03 EDT Fir Tree issues open letter to Halcon Board urging sale of Pecos assets - Fir Tree Capital Management, manager of certain funds that together have economic exposure to approximately 7.2% of the common stock of Halcon Resources, issued an open letter and presentation to the Board of Directors of Halcon complimenting the company's progress to date, highlighting the market's significant lack of appreciation for Halcon's share price and urging the company to take specific additional steps to maximize long term shareholder value, including exploring a sale of the company. Reference Link
TKPYY

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09:01 EDT Takeda Pharmaceutical's Trintellix adds labeling data on sexual dysfunction - Takeda Pharmaceuticals and Lundbeck announced that the FDA approved a supplemental new drug application for Trintellix, a prescription medication used for adults with major depressive disorder. The Trintellix U.S. prescribing information now includes head-to-head clinical study data that demonstrated superiority to a commonly-used selective serotonin reuptake inhibitor, Lexapro in improving treatment-emergent sexual dysfunction. In the study, patients with well-treated depression who were experiencing TESD while taking an SSRI were switched to Trintellix or escitalopram. This is the first time an antidepressant has included data of this type in its labeling. Trintellix demonstrated statistically significant improvement vs. escitalopram from baseline to week eight. Both drugs maintained prior improvement in depression based on overall score on standardized depression rating scale. Vortioxetine is approved in 77 countries and available in more than 60 countries to date. This is the second time this year FDA has approved an sNDA for Trintellix to add new data to the Trintellix U.S. labeling.
SVU

Hot Stocks

08:58 EDT Supervalu trading halted, news dissemination
IONS AZN

Hot Stocks

08:50 EDT Ionis Pharmaceuticals presents Phase 1b/2 data of danvatirsen - Ionis Pharmaceuticals (IONS) reported new data today on danvatirsen presented at the 2018 European Society for Medical Oncology Annual Congress. The study showed clinical and safety results from a phase 1b/2 trial evaluating danvatirsen, a Generation 2.5 antisense therapy targeting signal transducer and activator of transcription 3, in combination with durvalumab, AstraZeneca's (AZN) anti-PD-L1 antibody, in recurrent metastatic head and neck cancer. The combination treatment resulted in 7% of patients achieving a complete tumor response and 23% achieving either a partial or complete tumor response. This response rate is estimated to be double that with durvalumab alone, based on previous studies in this difficult to treat patient population. AstraZeneca is evaluating danvatirsen in a range of cancer types as part of a broader oncology partnership evaluating Generation 2.5 antisense therapies against undruggable targets either alone or in combination with immuno-oncology agents, including in non-small cell lung cancer, bladder cancer and head and neck cancer. Ionis earned a $17.5M milestone payment from AstraZeneca for advancing the phase 2 program for danvatirsen. Ionis is eligible for additional developmental and regulatory milestone payments from AstraZeneca, plus royalties on commercial sales of the drug.
AEE

Hot Stocks

08:49 EDT Ameren Missouri to acquire 157-megawatt wind facility in northwest Missouri - Ameren Missouri, a subsidiary of Ameren, announced that it has entered into an agreement to acquire, after construction, a wind generation facility of up to a 157-megawatts to be located in northwest Missouri. This agreement, along with the previously-announced planned addition of a 400 MW wind generation facility in northeast Missouri, continues Ameren Missouri's planned growth of renewable wind energy by 2020. The facility, developed by EDF Renewables North America, will be located in Atchison County. When operational in 2020, energy produced by the wind facility will power an estimated 47,000 homes. This new generation will help Ameren Missouri meet its goal of reducing carbon emissions 80 percent by 2050, based on 2005 levels. Ameren Missouri's planned additions will create approximately 280 jobs at the peak of construction, as well as several permanent jobs when the turbines are in service.
JTPY

Hot Stocks

08:45 EDT JetPay trading resumes
GWRS

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08:44 EDT Global Water Resources receives extension on taxable gain - Global Water Resources has received an extension from the Internal Revenue Service, or IRS, to defer the gain realized from the disposition of Valencia Water facility until the end of 2019. After taking into consideration the recent acquisition of Red Rock Utilities as well as the remaining projected capital investments in 2018, Global Water expects to apply approximately $7.5M of additional capital investment in 2019 to fully defer the tax gain. Global Water Resources earlier received a private letter ruling from the IRS that allowed the assets involuntarily converted upon the disposition of Valencia to be replaced with certain facility improvements or newly acquired facilities with the cost offset by the taxable gain from the disposition, according to Internal Revenue Code. The company has acquired four utilities and completed a number of capital improvements since the disposition in July of 2015. Additional investments to be applied against the taxable gain are currently scheduled to be completed in 2018 and 2019.
ORGS

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08:41 EDT Orgenesis enters collaboration with Hemogenyx for Hu-PHEC development - Orgenesis announced it has entered into a collaboration agreement with Hemogenyx Pharmaceuticals to collaborate on the development and commercialization of Hemogenyx's Human Postnatal Hemogenic Endothelial, or Hu-PHEC, technology. Hu-PHEC is a cell replacement product candidate that is being designed to generate cancer-free, patient-matched blood stem cells after transplantation into the patient. According to the terms of the agreement, Orgenesis shall manufacture and supply all Hu-PHEC related products both during and following completion of clinical trials. Orgenesis shall also receive the worldwide rights to market the products and shall serve as a global distributor of Hemogenyx's Hu-PHEC related products. In consideration for the license, Orgenesis and/or its affiliates will advance to Hemogenyx a convertible loan in an amount of no less than $1M for advancing the development of the Hu-PHEC technology. Orgenesis shall also pay a royalty of 12% of Orgenesis' net revenues resulting from the sale or licensing of products involving the use of Hemogenyx's Hu-PHEC technology.
CTR

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08:38 EDT Clearbridge MLP and Midstream Total Return Fund reaffirms name change - ClearBridge MLP and Midstream Total Return Fund , formerly known as ClearBridge Energy MLP Total Return Fund, reaffirmed that effective today, Monday, October 22, 2018, the Fund's name has been changed to ClearBridge MLP and Midstream Total Return Fund Inc. The Fund's shares of common stock will continue to trade under its existing New York Stock Exchange symbol "CTR". The Fund's CUSIP, 18469Q108, will not change. In addition, also effective today, October 22, 2018, under normal market conditions the Fund invests at least 80% of its managed assets in energy master limited partnerships and energy midstream entities. Previously, the Fund's investment policy provided that at least 80% of its managed assets be invested in energy MLPs. The name change and investment policy amendment should allow additional investment flexibility by permitting greater investments in midstream entities organized as C corporations. Management does not anticipate any material change in the portfolio construction in the near term because of these changes. For as long as "MLP" and "Midstream" are in the name of the Fund, the Fund will invest at least 80% of its managed assets in energy MLPs and energy midstream entities. The Fund may not change its policy to invest at least 80% of its managed assets in energy MLPs and energy midstream entities unless it provides stockholders with at least 60 days' written notice of such change.
CEM

Hot Stocks

08:37 EDT Clearbridge MLP and Midstream Fund reaffirms name change, amended policy - ClearBridge MLP and Midstream Fund Inc., formerly known as ClearBridge Energy MLP Fund, reaffirmed that effective today, October 22, 2018, the Fund's name has been changed to ClearBridge MLP and Midstream Fund Inc. The Fund's shares of common stock will continue to trade under its existing New York Stock Exchange symbol "CEM". The Fund's CUSIP, 184692101, will not change. In addition, also effective today, October 22, 2018, under normal market conditions the Fund invests at least 80% of its managed assets in energy master limited partnerships and energy midstream entities. Previously, the Fund's investment policy provided that at least 80% of its managed assets be invested in energy MLPs. The name change and investment policy amendment should allow additional investment flexibility by permitting greater investments in midstream entities organized as C corporations. Management does not anticipate any material change in the portfolio construction in the near term because of these changes. For as long as "MLP" and "Midstream" are in the name of the Fund, the Fund will invest at least 80% of its managed assets in energy MLPs and energy midstream entities. The Fund may not change its policy to invest at least 80% of its managed assets in energy MLPs and energy midstream entities unless it provides stockholders with at least 60 days' written notice of such change.
CRVS

Hot Stocks

08:37 EDT Corvus Pharmaceuticals announces new data on CPI-444 at ESMO - Corvus Pharmaceuticals announced new data on a biomarker associated with patient response to therapy with CPI-444, an adenosine receptor antagonist. This "adenosine gene signature" has the potential to be used as a predictive biomarker for patient selection in future clinical studies of CPI-444 and other therapies targeting the adenosine pathway, including CPI-006. The biomarker data was presented in a poster discussion session at the European Society for Medical Oncology, or ESMO. CPI-444, Corvus' lead product candidate, is a selective and potent inhibitor of the adenosine A2A receptor. It is currently being evaluated in clinical trials in patients with various solid tumors as a single agent and in combination with Genentech's atezolizumab, an anti-PD-L1 antibody. CPI-006 is a humanized monoclonal antibody directed against CD73. It is currently being evaluated in an early-stage, three-arm clinical trial in patients with a variety of solid tumors as a single agent, in combination with CPI-444, and in combination with pembrolizumab, an anti-PD-1 antibody.
GTN

Hot Stocks

08:36 EDT Gray Television reports proposed $2.15B incremental term loan - Gray Television announced that it is proposing, subject to market and other conditions, to replace its existing priority revolving credit facility with a new pari passu five-year revolving credit facility, amend its current term loan, and incur up to $2.15B of additional term loans under its senior credit facility. Gray expects to amend its Senior Credit Facility through some or all of the following, which would: Amend certain terms of its revolving credit facility, increase the amount available under the revolver from $100M to $200M, and extend the maturity from February 2022 to October 2023; Amend certain terms of its existing $595M term loan that matures in February 2024; and Incur up to an additional $2.15B seven-year incremental term loan under the Senior Credit Facility to finance, in part, the previously announced acquisition of Raycom Media, Inc.
ATIS

Hot Stocks

08:34 EDT Attis Industries secures Medicare license for Tulsa toxicology lab - Attis Industries announced that it has received the Medicare license for its toxicology laboratory in Tulsa, Oklahoma. The laboratory, which received its CLIA license in August, is dedicated to running samples reimbursed by Medicare and individual state Medicaid programs only. Now that Attis has received its CMS license, which provides Medicare coverage for all states, Attis will begin taking samples and billing under its new Medicare number while at the same time begin applying for Medicaid coverage for the states of Oklahoma, Arkansas, Kansas, Missouri, Texas, Colorado and New Mexico. Additionally, on October 18, Attis entered into an agreement with a tenant to sublease the office space of Attis' former corporate office through the end of the lease period. This will save the company over $300,000 in operating expenses per year.
PTGX

Hot Stocks

08:33 EDT Protagonist Therapeutics presents data from PROPEL study of PTG-100 - Protagonist Therapeutics presented clinical data from the PROPEL study of PTG-100, the company's oral, gut-restricted alpha-4-beta-7 integrin antagonist peptide for the treatment of ulcerative colitis, in a featured oral presentation at the United European Gastroenterology Week. Data from the PROPEL study demonstrated that treatment with PTG-100 was associated with higher rates of clinical remission relative to placebo. In addition, a dose-dependent increase in rates of histologic remission and target engagement based on blood biomarker of receptor occupancy was also observed in the study. No safety concerns were noted in the study. The histologic and blood biomarker data and topline safety data presented at the meeting expand upon the clinical remission and endoscopic response results announced previously in August 2018 that involved an independent, blinded re-read of endoscopies and had demonstrated signals of clinical efficacy. A human error in initial endoscopy reads by the original vendor which was characterized by an unusually high placebo effect (4/17, 23.5%) had led to the original futile outcome reported in March 2018.
CPST

Hot Stocks

08:33 EDT Capstone Turbine reports 1.6MW of microturbine rentals - Capstone Turbine announced it continues to expand into the Permian Basin with another 1.6 megawatts of long-term microturbine rentals on top of the initial 2.0 MWs rented just a week earlier. All 3.6 MWs are being rented by one of the world's largest oil and gas producers. Both long-term rentals were secured by Capstone's new distribution partner, Lone Star Power Solutions. The first two units were delivered and are in the process of being commissioned, while the next two C800 microturbines are expected to be delivered and commissioned in November.
NXTD

Hot Stocks

08:33 EDT Nxt-ID pushes back spin-off completion date - Nxt-ID released a shareholder update regarding LogicMark and the strategy and process for its proposed spin-off of its payments, authentication and credential management business. Nxt-ID CEO Gino Pereira stated, "The next step in the process of completing the spin-off is the filing of an information statement, which will provide additional details about the transaction and the resulting two businesses. It appears likely that our original estimated completion date of November 15 will be pushed back towards the end of the year but we are working diligently through the process."
MYSZ

Hot Stocks

08:32 EDT MySize partners with Lightspeed - My Size announced it has partnered with Lightspeed to provide access to its MySizeID mobile measurement solution to e-retailers worldwide.
APOP

Hot Stocks

08:28 EDT Cellect Biotechnology reports technological breakthrough in Apotainer production - Cellect Biotechnology has developed for industrialization its first in kind new technology as an integral part of Cellect's ApoTainer. The new technology utilizes FasL-coated magnetic beads for maximizing efficacy and scalability of stem cell-based products' manufacturing. The Apotainer improves the uniformity and hence quality of the outcome thereby supporting the safety and efficacy of raw material for all cell therapy. The enhancement of the ApoTainer with the Fas-L-presenting magnetic beads is designed to replace highly complex and expensive procedures currently used by laboratories.
AGLE

Hot Stocks

08:25 EDT Aeglea BioTherapeutics presents clinical data on pegzilarginase at ESMO - Aeglea BioTherapeutics announced that it presented clinical data for pegzilarginase in melanoma patients at the European Society for Medical Oncology, or ESMO. Clinical data from the company's ongoing Phase 1 clinical trial investigating pegzilarginase as a single agent includes expansion cohorts for cutaneous melanoma and uveal melanoma. Pegzilarginase demonstrated single agent anti-tumor activity in patients with advanced melanoma. Pegzilarginase rapidly and sustainably depleted plasma arginine with a manageable safety profile, treatment related adverse events were grade three or lower.
HCI

Hot Stocks

08:23 EDT HCI Group estimates $6M-$18M in losses from Hurricane Michael - HCI Group has issued an initial loss estimate from Hurricane Michael, which made landfall near Mexico Beach, Florida. The company's preliminary estimates indicate losses related to Hurricane Michael will be in the range of $6M-$18M. The company's reinsurance retention for the hurricane season is $16M.
GHDX

Hot Stocks

08:23 EDT Genomic Health reports results from multiple studies of Oncotype cancer tests - Genomic Health announced results from multiple studies of its Oncotype DX tests highlighting their value in optimizing treatment for patients with various stages of breast and prostate cancer. The findings, presented at the ESMO Congress in Munich, demonstrated that the Oncotype DX tests identify patients who will or will not benefit from a specific treatment. Two European-based studies demonstrated its impact on treatment decisions for women with node-negative and node-positive breast cancer. Additionally, three prostate cancer studies in the U.S. demonstrated how the Oncotype DX Genomic Prostate Score and AR-V7 Nucleus Detect tests refine treatment decisions in men with clinically low-intermediate risk or metastatic prostate cancer based on the aggressiveness of their tumor or their resistance to androgen receptor-targeted drugs. In Ireland, results showed that oncologists believed the test significantly changed their treatment recommendations 64% of the time, and that use of the Oncotype DX test led to a 27% reduction in recommendations for chemotherapy. Results from a real-life, decision-impact study of breast cancer patients in France and Italy showed that treatment recommendations changed in 35% of patients based on their Oncotype DX test results, resulting in a 43% reduction in chemotherapy recommendations.
OMED

Hot Stocks

08:20 EDT OncoMed presents interim results for navicixizumab with paclitaxel at ESMO - OncoMed announced interim results from its ongoing Phase 1b trial investigating navicixizumab, OncoMed's anti-DLL4/VEGF bispecific antibody, in combination with paclitaxel in patients with platinum-resistant ovarian cancer. The interim results were presented at the European Society for Medical Oncology, or ESMO. The patients had received a median of four prior therapies, all of whom had received prior paclitaxel and 69% had received prior bevacizumab. Twenty-two of the 26 patients treated with the novel regimen experienced clinical benefit. Notably 11 of the 26 patients achieved a partial response and the median progression-free survival was 5.4 months. Historical response rates for patients with heavily pretreated platinum-resistant ovarian cancer treated with chemotherapy are typically 15% or less. The ongoing Phase 1b multicenter, open-label, dose-escalation and expansion trial is designed to assess the safety, preliminary efficacy, immunogenicity, pharmacokinetics and biomarker effects of navicixizumab plus paclitaxel. The trial has been expanded to enroll up to 60 patients with platinum-resistant ovarian cancer who have previously received bevacizumab and/or have failed at least two prior therapies.
HALO

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08:18 EDT Halozyme reports results of data for PEGPH20 combination - Halozyme presented data from two clinical trials for PEGPH20 in patients with advanced pancreas and metastatic breast cancer at the annual European Society for Medical Oncology Congress in Munich. PEGPH20 is Halozyme's proprietary PEGylated recombinant human hyaluronidase enzyme being developed as an investigational new drug for the treatment of advanced pancreas cancer. This study has enrolled 60 patients with advanced pancreatic adenocarcinoma. The primary objective was the rate of symptomatic TE events, and the secondary objectives included PFS, OS and major bleeding rate. Two grade 3/4 TE events occurred, and two grade 3 GI hemorrhages; these AEs resolved with supportive treatment. There were three complete responses, 28 partial responses, 20 stable disease responses, and 9 progressive disease/non-evaluable responses. Median PFS is 7.0 months across both cohorts, and median overall survival has not been reached. Efficacy and safety are similar for patients with and without prior TE. The second study enrolled 14 patients with HER2 negative metastatic breast cancer without regard for HA status. No complete responses were reported, four - 28.6% - patients had a partial response and three - 21% - had stable disease. Drug related treatment emergent adverse events occurred in 86% of patients, with 79% of patients experiencing grade 3 or higher TEAEs. There were three serious adverse events, and the overall safety profile for PEGPH20 + eribulin mesylate was in line with previous observations, with no new safety signals identified. 1.6ug/kg was determined to be the appropriate dose for this combination. An additional response was confirmed following the data cutoff, increasing the overall response rate to 36%. The overall response rate is encouraging and the PEGPH20 + eribulin mesylate combination warrants further investigation.
EGL

Hot Stocks

08:18 EDT Engility wins $12.2M task order in Q3 - Engility Holdings won a $12.2M task order in the third quarter of the year on the Department of State's Africa Peacekeeping Program indefinite-delivery, indefinite quantity vehicle, known as AFRICAP III. The company will provide a host of logistics training services in the Central African Republic.
ALNA

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08:17 EDT Allena Pharmaceuticals presents ALLN-346 data at ACR/ARHP - Allena Pharmaceuticals announced preclinical proof-of-concept data for ALLN-346, its lead product candidate for hyperuricemia and gout in the setting of advanced chronic kidney disease, or CKD. The data were presented at the 2018 American College of Rheumatology, or ACR/ARHP. The poster presentation includes data demonstrating urate reduction in a urate oxidase knock-out mouse model, an animal model of severe hyperuricemia with kidney damage due to urate crystal deposition. After one week of treatment, mice treated with ALLN-346 achieved a substantial reduction in urate burden on the kidney, as evidenced by normalization in urine uric acid and a significant reduction in plasma urate.
NCR JTPY

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08:17 EDT NCR Corp. to acquire JetPay for $5.05 per share - NCR Corporation (NCR) announced a definitive agreement to acquire Allentown, PA-based JetPay (JTPY). The transaction will be a cash tender offer of $5.05 per JetPay share, which represents a multiple of 2.9 times 2018 consensus revenue forecast of $63.4 million. The purchase price is approximately $184 million and will be financed with a combination of cash on hand and existing capacity under NCR's revolving credit facility. The offer has been approved by each company's board of directors. This acquisition will enable NCR to integrate a cloud-based payments platform into its enterprise point-of-sale solutions for retail and hospitality industries. It also accelerates NCR's strategy of increasing recurring revenue growth and expanding margins by enhancing its mix of software and services. The transaction is anticipated to close by year-end, subject to regulatory approval and other customary closing conditions. The two companies anticipate a smooth transition for customers, channel partners and employees. Two of JetPay's major stockholders, Flexpoint Ford, a private equity investment firm that specializes in the financial services and healthcare industries, and Larry Stone, a longstanding executive in the payment processing industry, have agreed to tender their shares in support of the transaction.
LII

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08:16 EDT Lennox raises FY18 estimated business interruption impact from tornado - "For 2018, we are raising the estimated business interruption impact from the tornado, which will reverse to a benefit in 2019 upon the receipt of insurance proceeds," said Chairman and CEO Todd Bluedorn. "We are also rebalancing the expected tornado impact between the third and fourth quarters of 2018. We had guided that one-third of the impact would be in the third quarter and now expect that approximately 40% of the impact was in the third quarter. We had estimated two-thirds of the impact to come in the fourth quarter and now expect that approximately 60% of the impact will be in the fourth quarter. Third-quarter EPS was up 8% but was impacted by lost profits from the tornado of $0.52 per share, about $0.17 higher than estimated for the quarter. Turning to business segment results, Residential and Commercial set new third-quarter highs for revenue, and Refrigeration established a new high for segment margin. In Residential, impacted by the tornado, revenue rose 1%, profit was down 1%, and segment margin was down 40 basis points to 19.0%. In Commercial, revenue rose 2%. Segment profit was down 7%, and margin was down 170 basis points to 16.9%. Commercial national account equipment revenue, lumpy on a quarter-to-quarter basis, was down low-single digits compared to 20% growth in the prior-year quarter, and Europe HVAC revenue was down double digits on continued softness in the region. In Refrigeration, revenue was up 4%. Refrigeration profit rose 19%, and margin expanded 190 basis points to 15.4%. While there are moving pieces and noise from the tornado impact in the reported results, we remain focused on normalizing Residential production and continuing to execute on all our corporate initiatives to drive performance and shareholder value. We plan to repurchase $100 million of stock in the fourth quarter as we look toward a strong close to 2018 and ahead to 2019."
INO

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08:14 EDT Inovio presents data on Phase 1b INO-5150 study at ESMO - Inovio announced that new data from the company's recently completed Phase 1b study with INO-5150 demonstrated a slowing of Prostate-Specific Antigen Doubling Time, or PSADT, in men with prostate cancer. Overall, 86% of patients remained progression-free at Week 72 of the study. These data were presented in a poster at the European Society for Medical Oncology, or ESMO. In this study, Inovio evaluated the tolerability and immunogenicity of INO-5150, a DNA vaccine encoding PSA and PSMA, with or without INO-9012, in men with biochemically relapsed prostate cancer. The study demonstrated a slowing of PSA doubling time, a measure of disease progression, in a majority of patients on the study. In addition, 86% of patients were progression-free at Week 72 of the study, which in this treatment-refractory, high-risk patient population, is thought to be clinically promising. Importantly, analyses demonstrated that immunogenicity was observed in 77% of patients by multiple immunologic assessments.
RDC

Hot Stocks

08:13 EDT Rowan Stavanger awarded contract by Equinor - Rowan Companies announced that the Rowan Stavanger, an N-Class ultra-harsh environment jack-up rig, has been awarded a contract in Norway by Equinor with a firm term of approximately five months plus options. The contract is expected to commence the third quarter of 2019. The Rowan Stavanger is currently on the Yme field for accommodations and platform support services for Repsol in Norway. In addition, Equinor and Rowan have also executed a Master Framework Agreement which facilitates future contracts.
FLL

Hot Stocks

08:12 EDT Full House Resorts receives acquisition proposal for $132.5M - Full House Resorts has received a proposal from Z Capital Partners, an alternative asset manager of private equity and credit funds, and its affiliate, Affinity Gaming, to acquire Full House Resorts. The proposed transaction would be structured as a cash or stock transaction with an enterprise value of the company of $132.5M, which equates to $1.79 per share on a fully diluted basis. Z Capital is 'confident' it can obtain any necessary debt financing commitments needed to complete the proposed transaction and would agree to a post-signing "go shop" period to satisfy the Board's fiduciary duties. Upon closing, the combined company would remain headquartered in Las Vegas, with a management team led by recently appointed Affinity CEO Tony Rodio.
EBAY

Hot Stocks

08:11 EDT eBay launches new program for consumers to instantly sell smartphones - For consumers looking for the quickest and easiest way to sell their unwanted smartphones with instant gratification, eBay has announced the launch of eBay Instant Selling. The new program allows consumers to sell their devices and get paid instantly with an eBay voucher, without having to manage the selling process. The entire process takes only a matter of minutes, from start to payment. Instant Selling removes time spent waiting for their device to sell with a new option to receive instant payment in the form of an eBay voucher once the phone is listed. Standard smartphone trade-in providers typically offer 40 to 50 percent off the average market selling price, while eBay provides a higher return - up to 40% higher than trade-in values, on average.
URI

Hot Stocks

08:10 EDT United Rentals acquires WesternOne Rentals & Sales for $91.8M in cash - United Rentals announced that United Rentals of Canada, Inc., a wholly-owned subsidiary of the company, has entered into a definitive agreement to acquire the assets of WesternOne Rentals & Sales from parent WesternOne Inc. for approximately $91.8M in cash. The transaction is expected to close before year-end subject to approval by the shareholders of WesternOne and certain other customary conditions. It is not contingent on financing, and is not expected to have a material impact on the revenues or earnings of United Rentals.
ZAYO

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08:09 EDT Major retailer selects Zayo for nationwide network - A major retailer has selected Zayo Group Holdings for a wavelength solution, connecting its core and edge data centers across the U.S. The solution includes fully diverse 10G and 100G wavelengths. The network will support the retailer's initiative for a seamless experience from their physical stores to their online site, including rapid home and business delivery across the U.S. The initiative depends on big data analytics that track buyer behavior, optimize the supply chain, and forecast and manage inventory.
TBPH

Hot Stocks

08:08 EDT Theravance Biopharma reports data from TD-1473 Phase 1b study - Theravance Biopharma reported the results from the exploratory Phase 1b study of the gut-selective pan-Janus kinase inhibitor TD-1473 in an oral presentation as part of the late-breaker session at United European Gastroenterology Week 2018. Presented data demonstrated that four weeks of TD-1473 treatment led to signals of biological activity and localized target engagement with low systemic exposures and no evidence of systemic immunosuppression or opportunistic infections in patients with moderately to severely active ulcerative colitis. The Phase 1b exploratory study was designed to evaluate the safety, tolerability, and pharmacokinetics of TD-1473 over a 28-day treatment period. Trends were observed for higher rates of clinical response for TD-1473 after four weeks of treatment as compared to placebo. Clinical response was achieved by 2 of 10 patients in the 20 mg cohort, 2 of 10 patients in the 80 mg cohort, and 6 of 11 patients in the 270 mg cohort, compared to 1 of 9 patients in placebo group. TD-1473 was generally well tolerated in the study with no adverse events leading to study drug interruption or discontinuation. There were two serious adverse events which were characterized as hospitalizations for UC exacerbations. Theravance Biopharma is advancing the TD-1473 program into a Phase 2 clinical trial in patients with moderately to severely active Crohn's disease, as well as a Phase 2b/3 induction and maintenance study in ulcerative colitis.
MLNT...

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08:07 EDT Melinta Therapeutics CEO Dan Wechsler steps down, John Johnson named interim - Melinta Therapeutics (MLNT) announced that its board of directors has appointed John Johnson as interim CEO, effective immediately. Johnson, a director of Melinta, succeeds Dan Wechsler, who is stepping down from his role as president, CEO and director to pursue other opportunities. The board and Wechsler mutually agreed that now is the right time to transition leadership of the company. Johnson has more than 30 years of biopharmaceutical industry, executive leadership and commercial experience at leading global organizations. In addition to Melinta, Johnson currently serves on the boards of Aveo Oncology (AVEO), Histogenics Corporation, Portola Pharmaceuticals (PTLA), and is chairman of Strongbridge Biopharma (SBBP). Johnson previously served as a director at Cempra and Sucampo.
CRBP

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08:06 EDT Corbus data shows 'favorable' safety profiles maintained with Lenabasum - Corbus Pharmaceuticals Holdings announced continued safety and tolerability profiles and further improvement in efficacy outcomes in open-label extensions of lenabasum Phase 2 studies in two rare and serious autoimmune diseases, systemic sclerosis and dermatomyositis. Eighteen-month data from the SSc OLE and 12-month data from the DM OLE are being presented at the American College of Rheumatology 2018 Annual Meeting in Chicago. Further improvement in skin thickening from study start was observed using the modified Rodnan Skin Score, reaching -8.4 points at 6 months, -9.8 points at 12 months, and -10.7 points at 18 months. An improvement of -4 to -5 points in mRSS is considered medically important, and 87% of subjects had an improvement in mRSS of at least -5 points and 60% had an improvement in mRSS of at least -10 points at 18 months in the OLE. Continued improvement in overall disease was observed in SSc subjects using a composite outcome, the ACR CRISS score, which increased from a median of 0% at the start of the SSc OLE to 65% at 6 months to 77% at 12 months, then 99% at 18 months. A CRISS score of about 60% has been reported to be medically important, and 75% of subjects had a CRISS score of 60%, and 50% had a score of 100% at 18 months. Measures of patient global health, skin symptoms, itch, and patient-reported disability and function all improved during the SSc OLE, with improvement increasing throughout the OLE or stabilizing from months 12-18. 83% of subjects who entered the OLE remained in the study at 18 months. Continued improvement in inflammatory skin involvement was observed in DM subjects using a composite outcome, the Cutaneous Dermatomyositis Activity and Severity Index activity score. The CDASI activity score improved from study start by a mean of -15.4 points at 6 months to -17.6 points at 12 months in the OLE. An improvement of -4 to -5 points in CDASI activity score is considered medically important, and 84% of subjects had improvement in CDASI activity score exceeding -10 points at 12 months in the OLE.
GOOG...

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08:04 EDT Tendril, Google collaborate for energy info for Indiana Michigan Power customers - Tendril announced a new collaboration with Google (GOOG, GOOGL) that will provide voice-activated energy information and notifications to utility customers via the Google Assistant and Google Home devices. Indiana Michigan Power, an American Electric Power (AEP) company, will be the first utility to work with Tendril and to offer this functionality to its customers. With this partnership, utilities like I&M will leverage Tendril's vast amount of data on how consumers use energy to deliver rich insights and better manage energy in the home. The Tendril Platform will enable the delivery of energy insights through any device that supports the Google Assistant. Specifically, it will combine utility customer usage and billing information with thousands of data points on each home and their occupants to provide feedback about energy usage and notifications. This additional interaction with smart devices in the home builds on an existing effort between the two companies to better manage residential load using Nest thermostats.
LII

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08:04 EDT Lennox plans $100M of stock repurchases for Q4
EIGR

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08:04 EDT Eiger BioPharmaceuticals' lonafarnib receives RPD designation from FDA - Eiger BioPharmaceuticals announced that the FDA has granted Rare Pediatric Disease designation to lonafarnib in the treatment of both Hutchinson-Gilford Progeria Syndrome and progeroid laminopathies. RPD designation for progeria and progeroid laminopathies enables priority review voucher eligibility upon FDA approval of a rare pediatric disease product application for lonafarnib for these ultra-rare and fatal genetic conditions characterized by accelerated aging in children. Eiger is collaborating with The Progeria Research Foundation in this lonafarnib program and plans to submit a new drug application to the FDA in 2019. There is no approved treatment for progeria or progeroid laminopathies.
BLMN

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08:03 EDT Barington calls on Bloomin' directors to improve board oversight of management - Barington Capital Group, which represents a group of shareholders of Bloomin' Brands, announced that it has sent a letter to the independent directors of Bloomin' expressing its concern over the company's sustained period of underperformance under the leadership of the company's Chairman and CEO, Elizabeth A. Smith. In the letter, Barington highlights a number of troubling trends at the company under Ms. Smith's leadership, including a multi-year period of declining market share, weak revenue growth despite elevated advertising expenses and capital expenditures, recurring impairment charges, excessive corporate expenses, lower operating margins than the company's peers, substantial stock sales by the CEO, and poor corporate governance. Barington also states in the letter that it believes the company has insufficient strategic focus, and that performance has been hindered by the complexity of its business structure. Barington believes that the Company's attempt to operate four divergent brands has negatively impacted strategic focus and operating execution at each of its businesses, making it more difficult for them to compete with their nimbler competitors. Barington therefore recommends that the company sharpen its strategic focus by pursuing a spinoff or sale of Bonefish Grill, Carrabba's and Fleming's, leaving Outback Steakhouse to operate independently. Barington believes that the company has a substantial value potential that is not being realized and is convinced that the Company can perform substantially better. Barington therefore calls upon the company's independent directors to (1) appoint an independent Chairman to help improve Board oversight of management and the strategic direction of the company, (2) retain a financial advisor to help the Board evaluate alternatives to enhance the company's strategic focus, and (3) declassify the Board and adopt a majority vote standard for uncontested director elections to help improve the company's corporate governance.
ACN

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08:01 EDT Accenture agrees to acquire New Content, terms not disclosed - Accenture has entered into an agreement to acquire New Content, an independent Brazilian content marketing agency, to strengthen its customer experience services provided through Accenture Interactive. The acquisition will enhance Accenture Interactive's ability to serve its clients in Latin America with branded and strategic content that connects people and brands, and helps clients maximize the return-on-investment of their marketing programs. The acquisition is subject to customary closing conditions. Financial terms of the transaction were not disclosed.
MRTX

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07:55 EDT Mirati Therapeutics provides sitravatinib update after meeting with FDA - Mirati Therapeutics provided an update on the regulatory pathway for sitravatinib in checkpoint refractory NSCLC patients following a end of phase 2 meeting with the FDA. Based on guidance received from the FDA, Mirati plans to initiate a Phase 3 randomized clinical trial in second line patients comparing the combination of sitravatinib plus a checkpoint inhibitor to docetaxel in patients whose tumors have progressed on prior checkpoint inhibitor therapy. The trial will include an interim analysis of overall response rate as a surrogate endpoint to serve as the basis for potential Subpart H accelerated approval. This interim analysis and the use of a docetaxel control arm follows clear guidance from the FDA. The primary endpoint of the final analysis for the Phase 3 clinical trial will be overall survival. The trial will enroll patients with NSCLC whose tumors have progressed following treatment with a checkpoint inhibitor and platinum-based chemotherapy. Patients will be randomized for treatment with either the combination of sitravatinib with a checkpoint inhibitor or single-agent docetaxel. The company plans to initiate the pivotal Phase 3 in the first half of 2019. Ultimately, the company expects this trial to enable a new drug application, or NDA, for the treatment of NSCLC patients whose tumors have progressed following treatment with a platinum containing regimen and a checkpoint inhibitor.
JTPY

Hot Stocks

07:55 EDT JetPay trading halted, news pending
SBBP

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07:52 EDT Strongbridge Biopharma presents results from Phase 3 SONICS study at ENEA - Strongbridge Biopharma announced that results from its pivotal Phase 3, open-label, single-arm SONICS study, which evaluated the safety and efficacy of Recorlev in patients with endogenous Cushing's syndrome, were presented at the 18th Annual Congress of the European NeuroEndocrine Association, or ENEA. The SONICS study met its primary endpoint, with mean urinary free cortisol, a surrogate endpoint that predicts clinical outcomes, confirmed normal among 30% of the intent-to-treat population, without a preceding dose increase following six months of maintenance therapy. Top-line efficacy results were previously reported in August.
FLXN

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07:43 EDT Flexion to present data from Phase 2 Zilretta study at ACR - Flexion will present the results from a Phase 2 clinical trial evaluating the pharmacokinetics, or PK, and safety of concurrent administration of Zilretta in patients with bilateral osteoarthritis, or OA. Results indicate that bilateral injections of Zilretta were well tolerated and resulted in substantially lower plasma concentrations of triamcinolone acetonide compared to immediate-release triamcinolone acetonide in crystalline suspension, or TAcs. These data will be presented in a poster session at the 2018 American College of Rheumatology, or ACR. Exposure to triamcinolone acetonide was significantly lower in patients given Zilretta compared to those given TAcs, with maximum plasma concentrations nearly 10-fold lower. Safety profiles were similar for Zilretta and TAcs treatment groups, and both treatments were generally well tolerate. Neither bilateral injections of Zilretta nor TAcs resulted in prolonged decreases in systemic cortisol production and there were no serious treatment emergent adverse events, or TEAEs, and no patients discontinued the study. The Phase 2 open-label study randomized 24 people with bilateral OA to receive concurrent injections of either Zilretta or TAcs in both knees. The most common TEAE related to study drug in patients given Zilretta was injection site pain. In patients given TAcs, the most common TEAEs related to study drug were arthralgia and joint swelling.
KMB

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07:38 EDT Kimberly-Clark sees FY18 share repurchases $800M - Third quarter 2018 share repurchases were 1.6M shares at a cost of $173M. The company expects full-year repurchases of $800M, consistent with the original target range of $700M-$900M. Total debt was $7.5B at September 30, 2018 and $7.4B at the end of 2017.
KMB

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07:37 EDT Kimberly-Clark provides update to 2018 guidance - The company updated the following key planning and guidance assumptions for full-year 2018: Net sales similar year-on-year (prior assumption similar, to up 1 percent). Changes in foreign currency exchange rates anticipated to have a 1 percent negative impact on net sales (previous estimate neutral to 1 percent negative impact). Organic sales expected to increase approximately 1 percent (no change). Adjusted operating profit decline at the high end of, or slightly more than, the prior estimate for a 2 to 5 percent decline. Inflation in key cost inputs in the upper half of the previously estimated range of $675 to $775 million. Currency effects somewhat more unfavorable than previously assumed. Adjusted effective tax rate expected to be 21 to 22 percent (prior assumption at the low end of the 23 to 26 percent range). FY18 EPS, revenue consensus $6.64, $18.34B, respectively.
KMB

Hot Stocks

07:35 EDT Kimberly-Clark CEO says profitability impacted by commodity, currency headwinds - Chairman and CEO Thomas Falk said, "We delivered 1 percent organic sales growth in the third quarter, reflecting our initiatives to improve selling prices and product mix. While our profitability was impacted by significant commodity and currency headwinds, we continue to launch innovations, pursue our growth priorities and invest in our brands for long-term success. We also continue to manage our company with financial discipline, as we generated total cost savings of $145 million, reduced discretionary spending and returned approximately $520 million to shareholders through dividends and share repurchases. For the full year, we are confirming our previous outlook for organic sales growth and adjusted earnings per share."
ZLAB

Hot Stocks

07:34 EDT Zai Lab announces approval of Zejula for patients with relapsed ovarian cancer - Zai Lab Limited announced that the Hong Kong Department of Health has approved ZEJULA, an oral, once-daily poly polymerase inhibitor in Hong Kong for adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian cancer who are in a complete response or partial response to platinum-based chemotherapy. Unlike other PARP inhibitors approved in Hong Kong, ZEJULA does not require BRCA mutation or other biomarker testing prior to administration. The approval of ZEJULA in Hong Kong was based upon the international Phase 3 ENGOT-OV16/NOVA trial sponsored by TESARO, Inc., a double-blind, placebo-controlled study that enrolled 553 patients with relapsed predominantly high grade serous ovarian, fallopian tube, or primary peritoneal cancer who were platinum sensitive, defined by a CR or PR for more than six months to their penultimate platinum-based therapy. The primary endpoint of the trial was progression free survival. Approximately two-thirds of study participants did not have germline BRCA mutations. Progression in the NOVA study was determined by a robust, unbiased, blinded central review to be the earlier of radiographic or clinical progression. ZEJULA significantly increased PFS in patients both with and without germline BRCA mutations as compared to the control arm. Treatment with ZEJULA reduced the risk of disease progression or death by 73% in patients with germline BRCA mutations and by 55% in patients without germline BRCA mutations. The magnitude of benefit was similar for patients entering the trial with a CR or PR.
BGNE

Hot Stocks

07:34 EDT BeiGene announces preliminary data from pamiparib study at ESMO - BeiGene announced that preliminary clinical data from an ongoing Phase 1 trial of its investigational PARP inhibitor, pamiparib, in combination with low-dose temozolomide in patients with locally advanced or metastatic solid tumors were presented at the European Society for Medical Oncology, or ESMO. Discovered by BeiGene scientists in Beijing, pamiparib is currently in Phase 3 trials globally and in China as a monotherapy and in Phase 1/2 trials in combination with chemotherapy or immunotherapy for a variety of solid tumors. This open-label, multi-center Phase 1b dose-escalation trial of pamiparib plus low- dose temozolomide, or TMZ, was designed to evaluate the safety, tolerability, maximum tolerated dose, or MTD, and preliminary antitumor activity of the combination in patients with locally advanced and metastatic tumors. Patients received full-dose pamiparib in combination with escalating doses of TMZ, administered in both pulse and continuous dosing schedules. As of August 24, a total of 40 patients with solid tumors have been enrolled in the study. Patients had received a median of four prior lines of therapy. The median duration of treatment was 1.6 months. As of the data cutoff, a total of 18 patients remained on pamiparib and TMZ treatment. The combination was shown to be generally well tolerated. Dose-limiting grade 4 neutropenia was observed in two patients treated with 120 mg TMZ Days 1-7 and two patients treated with 100 mg TMZ Days 1-7. The most common treatment-emergent adverse events, or TEAEs, regardless of grade or attribution, were nausea, anemia, neutropenia, thrombocytopeni, and fatigue. TEAEs grade occurred in 18 patients. The most common grade 3 or 4 adverse events, or AEs, were neutropenia, anemia and thrombocytopenia. Cytopenias were manageable and reversible. Two patients experienced AEs that resulted in discontinuation of pamiparib and TMZ, one of which was considered related to study treatment. Serious AEs considered related to study treatment occurred in four patients. There were no AEs with fatal outcome. Twenty-three patients with solid tumors other than prostate cancer were evaluable per RECIST v1.1. Preliminary data showed that two patients achieved a confirmed partial response, or PR, including one patient with pancreatic cancer and one patient with small cell lung cancer. Two additional patients achieved an unconfirmed PR, including one patient with BRCA-mutated triple-negative breast cancer treated with 80 mg TMZ Days 1-7, and one patient with urothelial cancer treated with 40mg TMZ Days 1-7. Ten patients had a best response of stable disease; four patients had a best response of disease progression; and five patients were not evaluable for RECIST response either due to lack of a post-baseline tumor assessment or non-measurable disease at baseline.
KMB

Hot Stocks

07:33 EDT Kimberly-Clark names Michael Hsu as CEO, succeeding Thomas Falk - Kimberly-Clark announced that its Board of Directors has named Michael Hsu, 54, CEO, effective January 1, 2019. Hsu will continue to serve as a member of the company's Board of Directors. Hsu has served as Kimberly-Clark's President and COO since January 1, 2017. Before that, he oversaw the company's nearly $8B North American Personal Care and Consumer Tissue businesses. Hsu succeeds Thomas Falk who has served as CEO since 2002 and Chairman of the Board of Directors since 2003. Falk will become Executive Chairman of the Kimberly-Clark Board of Directors to help ensure a smooth transition.
KLXE

Hot Stocks

07:33 EDT KLX Energy to acquire Motley Services for total consideration of $148M - KLX Energy Services Holdings announced that it has entered into a definitive agreement to acquire Motley Services, LLC, a large diameter coiled tubing service provider, serving customers primarily in the Southwestern U.S. Motley, a premier provider of well completion services, is primarily focused on providing high-quality large diameter coiled tubing services specializing in complex, longer lateral horizontal wells. Motley also provides wireline and thru-tubing services, which are complementary to KLX Energy Services' existing service offerings. Motley's third quarter 2018 revenues and EBITDA guidance, on an annualized basis based on the mid-point of the guidance, are approximately $136M and $46M, respectively. Under the terms of the agreement, KLX Energy Services will pay Motley total consideration of $148M, consisting of $139M in cash and $9M of KLX Energy Services common stock. Thecompany intends to fund the cash portion of the purchase price with the net proceeds of a debt financing. The transaction is subject to certain closing conditions, including approvals from regulatory authorities. There can be no assurance that the transaction will be completed.
NVCR

Hot Stocks

07:32 EDT Novocure announces publication of results of PANOVA phase 2 pilot trial - Novocure announced that the results of its PANOVA phase 2 pilot trial have been published in Pancreatology. The PANOVA pilot trial was a prospective, single-arm study testing the feasibility, safety and preliminary efficacy of Tumor Treating Fields in patients with advanced pancreatic cancer whose tumors could not be removed surgically and who had not received chemotherapy or radiation therapy prior to entering the clinical trial. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. The trial included 40 patients with advanced pancreatic cancer in two cohorts, 20 of whom received Tumor Treating Fields plus gemcitabine and 20 of whom received Tumor Treating Fields plus gemcitabine and nab-paclitaxel. The primary endpoint was safety. Secondary endpoints included progression free survival and overall survival. In the Tumor Treating Fields plus gemcitabine cohort, progression free survival and overall survival were each more than double those of the gemcitabine-treated historical control. Advanced pancreatic cancer patients treated with Tumor Treating Fields plus gemcitabine experienced a median progression free survival of 8.3 months and a median overall survival of 14.9 months, compared to 3.7 months and 6.7 months, respectively, in the gemcitabine historical control. In the Tumor Treating Fields plus gemcitabine and nab-paclitaxel cohort, progression free survival and the one-year survival rate were more than double those of the gemcitabine and nab-paclitaxel-treated historical control. Advanced pancreatic cancer patients treated with Tumor Treating Fields plus gemcitabine and nab-paclitaxel experienced a median progression free survival of 12.7 months, compared to 5.5 months in the nab-paclitaxel plus gemcitabine historical control. Median overall survival for the Tumor Treating Fields and gemcitabine plus nab-paclitaxel cohort was not yet reached. The one-year survival rate of patients treated with Tumor Treating Fields plus gemcitabine and nab-paclitaxel was 72 percent, compared to 35 percent in a gemcitabine plus nab-paclitaxel historical control. Twenty-one patients reported skin toxicity related to Tumor Treating Fields. No serious adverse events related to Tumor Treating Fields were reported. In December 2017, Novocure initiated its PANOVA-3 phase 3 pivotal clinical trial designed to determine the efficacy and safety of Tumor Treating Fields with nab-paclitaxel and gemcitabine as a front-line treatment for unresectable locally advanced pancreatic cancer.
KMB

Hot Stocks

07:32 EDT Kimberly-Clark names Michael Hsu as CEO, effective January 2019
IQV

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07:30 EDT Iqvia down 1.5% after reporting Q3 results, FY18 guidance
NCNA

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07:30 EDT NuCana PLC (ADS) trading resumes
ARII

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07:30 EDT American Railcar trading resumes
HSDT

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07:26 EDT Helius Medical receives market authorization for PoNS from Health Canada - Helius Medical announced its wholly owned subsidiary, NeuroHabilitation, received authorization from Health Canada to market its Portable Neuromodulation Stimulator, or PoNS, a class II medical device in Canada. The Health Canada Medical Device License certifies the PoNS Device meets all Canadian safety, effectiveness, and quality requirements. The Canadian Medical Device License approval was preceded by the company's achievement of ISO 13485 Certification, the international standard for medical device quality management systems.
IZEA

Hot Stocks

07:24 EDT Izea to execute holiday influencer marketing program for Fortune 10 customer - IZEA Worldwide announced that it has been selected to execute an influencer marketing program for a Fortune 10 customer to promote its products during the 2018 holiday season. The latest program is an expansion of an existing brand direct relationship which spans multiple divisions in the company and has now more than tripled in size year-to-date as compared to 2017. The company will be utilizing IZEA's managed services and the IZEAx influencer marketing platform to execute its program. IZEAx provides access to a marketplace of online influencers that can be engaged at scale to create sponsored posts on social media platforms.
SLS

Hot Stocks

07:24 EDT Sellas Life Sciences presents data from nelipepimut-S with trastuzumab trial - Sellas Life Sciences announced data from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial of the combination of nelipepimut-S, or NeuVax, NPS +/- trastuzumab targeting HER2 low-expressing breast cancer patient cohorts. The data were presented in an oral presentation at the European Society for Medical Oncology, or ESMO.
ASLN

Hot Stocks

07:20 EDT Aslan Pharmaceuticals presents new data for varlitinib with COX, FOL at ESMO - Aslan Pharmaceuticals announced the presentation of new data from an ongoing phase 1 study to determine the safety, tolerability and maximum tolerated dose, or MTD, of varlitinib in combination with oxaliplatin and capecitabine, or COX, or oxaliplatin and 5-FU, or FOL, in advanced solid tumors. The study findings, presented in a poster session at the 2018 European Society for Medical Oncology, or ESMO, indicate encouraging signs of efficacy for varlitinib as a treatment for late-stage oncology patients. Of 28 patients evaluable for response, 11% showed partial response, or PR, 57% experienced stable disease and 10 (36%) patients had PR or SD continuing beyond 18 weeks. The MTD for varlitinib in combination with COX and FOL was 300mg BID administered orally. Durable efficacy was seen in patients with biliary tract cancer and HER2 over-expressing colorectal cancer, with 7 patients having progression free survival over 24 weeks up to 92 weeks, all of whom had prior platinum exposure. As at April 12, four patients were still on study. The full study results are expected in the first half of 2019.
NNVC

Hot Stocks

07:17 EDT NanoViricides CEO comments on company pipeline - NanoViricides CEO Irach Taraporewala issued a letter to shareholders which states, among other things: "(...) the company is moving rapidly towards filing its first Investigational New Drug application with the FDA. The FDA looks for indicators of both efficacy and safety in its assessment of drug products. NanoViricides has obtained evidence that the shingles virus, VZV, is cleared effectively when virus-infected human skin is treated with the nanoviricides drug formulations targeting VZV. Importantly, this validation came from the laboratory of Dr. Jennifer Moffat at the SUNY Upstate Medical Center, an international expert. The nanoviricides drug formulations were also shown to be non-toxic in these ex-vivo human skin patch studies, using histological assessments. The drug candidates were also shown to be effective and non-cytotoxic in cell-culture studies. Preliminary animal toxicology studies conducted by the company have shown that its nanomedicine products are safe. All of these studies have paved the way for us to now conduct the Good Laboratory Practice-certified IND-enabling safety/toxicology studies required to be filed with the IND application that we will be submitting to the FDA (...) NanoViricides is now set for moving rapidly into the regulatory clinical trials stage of drug development. The company's broad and deep pipeline will enable us to bring several drugs into the clinical stage, one after another, once the first drug goes forward (...)"
ONDK PNC

Hot Stocks

07:15 EDT PNC to roll out digital business lending platform with OnDeck in 2019 - PNC Bank (PNC) announced that in 2019 it plans to begin offering fully digital business lines of credit, up to $100,000, in an expansion of its online lending to customers and prospects in the United States. "PNC's new digital product brings together one of the nation's largest banks and OnDeck (ONDK), the leader in online lending to boost small business. PNC will utilize OnDeck's Platform-as-a-Service solution to simplify and accelerate the conventional lending originations processes for PNC Bank's small and medium-sized business customers. PNC will combine its extensive product and credit expertise with ODX's online origination technology and professional services to create PNC Small Business Lending, a fully digital, online business credit origination solution," the companies stated. Lakhbir Lamba, head of Retail Lending at PNC Bank, said, "Our relationship with OnDeck is PNC's first opportunity to leverage the services of a fintech company in a platform-as-a-service model that will make it easier for businesses to borrow from us in order to support their growth."
NCNA

Hot Stocks

07:15 EDT NuCana presents data from Phase 1 NUC-3373 study at ESMO - NuCana announced the presentation of additional data from a Phase I clinical study of NUC-3373, its ProTide transformation of the active anti-cancer metabolite of 5-fluorouracil, or 5-FU, in patients with advanced solid tumors, at the European Society for Medical Oncology, or ESMO. To date, 36 patients, all with metastatic cancer, have been enrolled in the study, with 29 patients receiving NUC-3373 on a weekly schedule on days one, eight, 15 and 22 of a 28-day cycle at doses ranging from 125mg/m2 to 1,500mg/m2 and seven patients receiving NUC-3373 on an alternate-week, or fortnightly, schedule on days one and 15 of a 28-day cycle at doses ranging from 1,500mg/m2 to 1,875mg/m2. Notably, three patients achieved stable disease after treatment, with responses lasting more than nine months at the time of data cutoff on September 25.
MOH

Hot Stocks

07:14 EDT Atar Capital acquires Pathways from Molina Healthcare - Atar Capital announced that it has completed the acquisition of Pathways Health and Community Support from Molina Healthcare. Atar Capital also announced the appointment of Jill Winters, an experienced healthcare management executive, to lead Pathways as its new CEO. Winters held positions of increased responsibility over almost 20 years at UnitedHealthcare, serving as President of the company's Medicare & Retirement Central Region, as well as Chief Field Executive Officer of its Medicare Solutions business. She succeeds Interim CEO Craig Bass, who will remain at Molina Healthcare.
PEB LHO

Hot Stocks

07:14 EDT Pebblebrook Hotel clarifies cash election may be made after October 23 - Pebblebrook Hotel Trust (PEB) reminded current and future beneficial owners of common shares of LaSalle Hotel Properties (LHO) that, in accordance with the terms of the merger agreement between Pebblebrook and LaSalle, the deadline to elect to receive a portion of the merger consideration in the form of cash is after the record date for the scheduled special meetings of Pebblebrook's and LaSalle's shareholders. Although the record date for the special meetings is October 23, 2018, owners of LaSalle common shares may submit an election form, and submit superseding election forms if desired, to elect to receive cash up until 5:00 p.m. on November 26, 2018, which is the day before the special meetings are to be held. However, because banks, brokerage firms and other nominees may, pursuant to their own procedures, establish earlier election deadlines for their clients or customers who beneficially own LaSalle common shares in "street name," Pebblebrook strongly encourages all current and future beneficial owners of LaSalle common shares to read carefully any materials they receive from their bank, brokerage firm or other nominee and to follow the procedures established by their bank, brokerage firm or other nominee in order to make an election. In accordance with the terms of the merger agreement, upon completion of the merger, which is anticipated to occur on November 30, 2018, each LaSalle common share then outstanding will receive either a fixed amount of $37.80 in cash or a fixed exchange ratio of 0.92 Pebblebrook common share, depending on its record holder's election if properly completed and submitted by the election deadline described above. A maximum of 30% of the outstanding LaSalle common shares may be exchanged for cash. As previously announced, the registration statement on Form S-4 filed with the U.S. Securities and Exchange Commission in connection with the proposed merger, of which the preliminary joint proxy statement/prospectus is a part, is expected to be declared effective by the SEC on October 29, 2018. On that date, Pebblebrook expects to file and begin mailing to its shareholders the definitive joint proxy statement/prospectus.
AVEO

Hot Stocks

07:14 EDT Aveo announces updated interim results from Phase 2 of TiNivo study - Aveo Oncology and EUSA Pharma today announced the presentation of updated interim results from the Phase 2 portion of the TiNivo study, a Phase 1b/2 multicenter trial of oral, or PO, tivozanib in combination with intravenous, or IV, nivolumab, an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced or metastatic renal cell carcinoma. The results were presented today at European Society of Medical Oncology, or ESMO, 2018 Annual Congress, in a poster presentation titled "TiNivo: Tivozanib Combined with Nivolumab: Safety and Efficacy in Patients with Metastatic Renal Cell Carcinoma. The Phase 1b/2 study has enrolled a total of 28 patients. The Phase 2 portion of the study was designed to assess the safety, tolerability, and anti-tumor activity of the full dose and schedule of PO tivozanib, as established in the Phase 1b portion of the study, in combination with IV nivolumab. The combination was generally well tolerated. Treatment-related Grade 3/4 adverse events occurred in 60% of patients, the most common of which was hypertension. Interim efficacy was assessed in all 25 patients treated with the full dose and schedule of PO tivozanib in combination with IV nivolumab and enrolled at least 4 months prior to the data cutoff date. Of these, 13 had received at least one prior systemic therapy. An objective response rate was observed in 56% of patients, including 4% of patients achieving a complete response, and a disease control rate was observed in 96% of patients. At the time of data collection 52%, of patients remained on study. To date, a total of 72% of patients had tumor shrinkage of greater than or equal to 25%, with a majority of patients having disease control for greater than or equal to 48 weeks.
RARE RGNX

Hot Stocks

07:12 EDT Ultragenyx announces exclusive license to Regenxbio AAV vectors for gene therapy - Ultragenyx (RARE) announced it has exercised its option with Regenxbio (RGNX) to develop a gene therapy to treat patients with CDKL5 Deficiency Disorder, or CDD, utilizing Regenxbio's adeno-associated virus, or AAV, vectors, including AAV9. CDD is a severe and debilitating neurological disorder that shares many features of Rett Syndrome, though the two disorders are now considered distinct from each other.
ALPN

Hot Stocks

07:12 EDT Alpine says ALPN-101 demonstrates preclinical activity in inflammatory arthritis - Alpine Immune Sciences presented positive results from preclinical studies of its lead program ALPN-101, a dual ICOS/CD28 antagonist, in experimental models of inflammatory arthritis and multiple sclerosis. The data were presented on Sunday, October 21, 2018 in poster sessions during the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting in Chicago and the 143rd Annual Meeting of the American Neurological Association in Atlanta. ALPN-101, a Dual ICOS/CD28 Antagonist, Potently Suppresses Disease in Multiple Mouse Models of Autoimmunity: The preclinical studies presented at the ACR/ARHP Annual Meeting evaluated the activity of ALPN-101 in a collagen-induced arthritis and an experimental autoimmune encephalomyelitis model. Abatacept was used as a key comparator. Results showed: ALPN-101, given preventively or therapeutically, significantly reduced disease activity in CIA. ALPN-101 was more efficacious than interventions on the CD28 or ICOS pathways alone. In CIA, ALPN-101 inhibited multiple biomarkers associated with disease, including inflammatory cytokines, anti-collagen autoantibodies, and activated T cells. Therapeutic Candidate ALPN-101, a Dual ICOS/CD28 Antagonist, Demonstrates In Vivo Efficacy in an Experimental Autoimmune Encephalomyelitis Model: The preclinical study presented at the ANA Annual Meeting evaluated the activity of ALPN-101 in mouse EAE, a model for multiple sclerosis. Abatacept was also used as a comparator. Results showed: ALPN-101 was superior to abatacept in reducing EAE as assessed by body weight and clinical scores. ALPN-101 reduced pro-inflammatory cytokines and activated T cells in vitro and in vivo.
REXR

Hot Stocks

07:10 EDT Rexford Industrial acquires industrial property for $10.2M in San Diego - Rexford Industrial acquired a three-building industrial property for $10.2M, or $138 per square foot. The acquisition was funded with cash on hand. The property consists of three buildings located on separate land parcels, containing 73,747 square feet on 3.64 acres and is currently 31% occupied. The company intends to undertake minor functional and cosmetic upgrades on the two vacant buildings to capture full rents upon lease-up.
MOH

Hot Stocks

07:09 EDT Molina Healthcare agrees to sell Pathways Health and Community Support - Molina Healthcare announced that it has completed the sale of Pathways Health and Community Support, a provider of home and community-based human services, to Atar Capital, a global private investment firm. As part of Molina Healthcare's renewed focus on its health plan business and continued execution of its margin recovery and sustainability plan, the company identified Pathways as a non-core asset. Molina has sold the business for a nominal purchase price. Pathways provides national home and community-based human services. It offers a full spectrum of social service and behavioral health solutions to over 60,000 children, adults, and families in 17 states and the District of Columbia.
HAS

Hot Stocks

07:09 EDT Hasbro down 6.3% to $91.87 after Q3 results miss estimates
ARII

Hot Stocks

07:08 EDT American Railcar to merge with ITE Rail Fund subsidiary for $70.00 per share - American Railcar announced that it has entered into a definitive agreement to merge with a wholly-owned subsidiary of ITE Rail Fund, managed by ITE Management at a price of $70.00 per share, which is 51% above the October 19 closing price of $46.29. The transaction is valued at approximately $1.75B. The transaction is expected to close in Q4, subject to termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and other customary closing conditions. The transaction is not subject to any further due diligence or any financing conditions.
LADR

Hot Stocks

07:08 EDT Arch Street Capital acquires office portfolio from Ladder Capital - Arch Street Capital Advisors announced the acquisition of the Lafayette Park Office Campus located in the Minneapolis / St. Paul MSA, on behalf of an institutional client, acquiring the Portfolio from Ladder Capital as the seller. The Portfolio acquisition consists of four buildings which total to 677,514 SF of office space and is 100% leased to the State of Minnesota on a long-term basis. Strategically located proximate to the Minnesota State Capitol complex, the Portfolio has served as the headquarters for four state agencies since the mid-1980's.
MCRB

Hot Stocks

07:07 EDT Seres Therapeutics appoints Kevin Horgan, M.D., as Chief Medical Officer - Seres Therapeutics announced the appointment of Kevin Horgan, M.D., as Executive Vice President and Chief Medical Officer. Dr. Horgan will lead Seres' clinical development, clinical operations, regulatory affairs, and medical affairs functions. Dr. Horgan will succeed Seres' outgoing Chief Medical Officer, Michele Trucksis, Ph.D., M.D., who will continue to provide consulting services to the company. Most recently, Dr. Horgan was Vice President of Clinical Development at AstraZeneca.
IEP ARII

Hot Stocks

07:07 EDT Icahn agrees to sell American Railcar in deal valued at approx. $1.75B - Icahn Enterprises L.P. (IEP) announced that its majority-owned subsidiary, American Railcar Industries (ARII), entered into a definitive agreement to merge with a wholly-owned subsidiary of ITE Rail Fund L.P., managed by ITE Management L.P., at a price of $70.00 per share, which is 51% above the October 19, 2018 closing price of $46.29. The transaction is valued at approximately $1.75B which is a great result for all ARI shareholders. Icahn Enterprises first acquired its majority interest in ARI in 2010. At that time, we deployed our activist modus operandi and guided the company towards growth and increased profitability, enhancing value for all IEP unitholders. With today's transaction, IEP's investment in ARI has generated a total return of 423%, for a profit of approximately $757.2 million. Carl C. Icahn, Chairman of Icahn Enterprises, stated: "ARI is one of America's great companies. As one of the leading railcar manufacturers, it has played an important role in infrastructure development and economic growth throughout North America. I thank the management team and all our dedicated employees. You built a tremendous company and without you, we would not have achieved this great result." The transaction is expected to close in the fourth quarter of 2018, subject to termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and other customary closing conditions. The transaction is not subject to any further due diligence or any financing conditions.
NTEC

Hot Stocks

07:07 EDT Intec Pharma completes enrollment in Phase 3 trial of Parkinson's candidate - Intec Pharma completed patient enrollment in the company's pivotal Phase 3 clinical trial evaluating the safety and efficacy of Accordion Pill compared with immediate release CD/LD Sinemet as a treatment for the symptoms of advanced Parkinson's disease. The study enrolled 462 patients in the Sinemet titration period to provide approximately 300 patients to be randomized into the double-blinded portion of the study. The company expects to provide timelines for the validation, stability and bridging studies for the commercial manufacturing process around the end of the year.
ARII IEP

Hot Stocks

07:07 EDT Icahn agrees to sell American Railcar in deal valued at approx. $1.75B
ATNX

Hot Stocks

07:06 EDT Athenex: 11 patients achieved partial remission in Oraxol trial - Athenex announced the presentation of efficacy and safety data of Oraxol in the treatment of metastatic breast cancer patients who failed previous chemotherapies in a pharmacokinetics and phase II clinical trial conducted in Taiwan. The data were presented at the European Society for Medical Oncology Congress on October 21, 2018 in Munich, Germany. Oraxol is an innovative oral formulation of paclitaxel, a very effective and commonly used anti-cancer chemotherapy, combined with HM30181A. Results from twenty four patients with metastatic breast cancer were reported. Common metastatic sites included bone, liver, lungs, lymph nodes and 6 patients had greater than 3 metastasis. These patients failed a median of two previous chemotherapies. Eleven patients achieved partial remission, 10 patients had stable disease, and 3 patients had progressive disease, as shown in the waterfall plot of tumor responses below:
SEED

Hot Stocks

07:05 EDT Origin Agritech enters Share Subscription Agreement with Longhan Investment - Origin Agritech announced that the company entered into a Share Subscription Agreement with Longhan Investment Management. Under this agreement, Longhan will purchase 1,397,680 Shares of the company's common stock for an aggregate purchase price of $7,743,147.20. As previously announced, Origin has entered a strategic cooperation agreement with Longhan, under which Origin and Longhan will work together to start the commercialization of Integrated Saline-Alkaline Land Reclamation technology in 2019, both in China and globally. Origin and Longhan will integrate seed treatment, soil treatment technologies and seed breeding & biotechnology, as well as Origin's agricultural business platform. With Longhan's investment into the company's stock, both Origin and Longhan plan to speed up the strategic cooperation and the commercialization process for the ISALR technology.
ONCY

Hot Stocks

07:03 EDT Oncolytics: Pelareorep more than doubles OS at recommended Phase 2 dose - Oncolytics Biotech announced clinical trial results for pelareorep in the treatment of patients with KRAS mutant metastatic colorectal cancer. Patients receiving treatment with the recommended phase 2 dose of pelareorep in combination with FOLFIRI/B had progression free survival of 65.6 weeks and an overall survival of 107.5 weeks, which exceeded expectations when compared to historical data. Engagement of the adaptive immune system was also noted, suggesting that pelareorep promotes an inflamed tumor phenotype. This clinical data was presented at the annual European Society for Medical Oncology 2018 Congress, taking place October 19-23 in Munich. The poster titled "Dose finding and safety study of Reovirus with irinotecan/fluorouracil/leucovorin/bevacizumab in patients with KRAS mutant metastatic colorectal cancer: Final Results", was presented yesterday at ESMO. This phase 1 dose escalation study enrolled 36 patients with oxaliplatin refractory KRAS mutant metastatic colorectal cancer. The trial was designed to determine the maximum tolerated dose and a RPTD. Of the six patients receiving the RPTD, three had a partial response and the median PFS and OS were 65.6 weeks and 107.5 weeks, respectively, exceeding expectations when compared to historical data. Reovirus administration is marked by activation of cytotoxic T-cells and rapid maturation of dendritic cells. Reovirus is safe and well tolerated in combination with FOLFIRI and Bevacizumab.
USAP

Hot Stocks

07:03 EDT Universal Stainless & Alloy raises base price to 8% on steel long products - Universal Stainless & Alloy announced a base price increase of 3% to 8% on selected specialty steel long products. The increase will be effective for all non-contract new orders entered October 29 forward. Current electrode, material and energy surcharges will remain in effect.
RGNX RARE

Hot Stocks

07:03 EDT Regenxbio announces exclusive worldwide license with Ultragenyx - REGENXBIO (RGNX) announced that Ultragenyx Pharmaceutical (RARE) has exercised an option for an exclusive worldwide license to REGENXBIO's NAV Vectors, including NAV AAV9, for the treatment of CDKL5 Deficiency Disorder. Under the terms of the license, REGENXBIO will receive an upfront payment, ongoing fees, milestone payments and royalties on net sales of products incorporating NAV Vectors. The option exercised by Ultragenyx is the final remaining disease indication option under the 2015 license agreement between REGENXBIO and Dimension Therapeutics, Inc., a wholly owned subsidiary of Ultragenyx. CDD is a severe and debilitating neurological disorder that shares many features of Rett Syndrome, though the two disorders are now considered distinct from each other.
CTMX

Hot Stocks

07:03 EDT CytomX Therapeutics presents clinical data from Probody platform and CX-072 - Additional Data Supports PD-L1 Targeting Probody CX-072 as Well Tolerated with Antitumor Activity as Monotherapy and in Combination with Ipilimumab - CytomX Therapeutics presented clinical results from two arms of the PROCLAIM module, PROCLAIM-072, which is an ongoing Phase 1/2 trial evaluating CX-072, a Probody therapeutic targeting PD-L1, as monotherapy and in combination with Yervoy or Zelboraf in patients with advanced, unresectable solid tumors. Data from the CX-072 monotherapy arm and ipilimumab combination arm were presented at the 2018 Annual Meeting of the European Society of Clinical Oncology in Munich. CEO Sean McCarthy D.Phil stated, "CX-072 has demonstrated activity both as monotherapy and in combination with ipilimumab and is generally well tolerated in both regimens. We are advancing monotherapy CX-072 towards registrational studies and continuing to explore the full potential of the CX-072/ipilimumab combination". The maximum tolerated dose was not reached. The administration of monotherapy CX-072 was generally well tolerated with the majority of treatment-related adverse events Grade 1/2. Among 38 evaluable patients who received CX-072, objective responses were observed in 3 patients, all treated at a dose of greater than 3 mg/kg. Stable disease was observed in 15, 39% of patients for an overall disease control rate of 47%. For the 18 patients who received CX-072 greater than or equal to3 mg/kg, objective responses were observed in 3/18 - 17% - and the disease control rate was 61%.
LCI

Hot Stocks

06:56 EDT Lannett enters into distribution agreement with Adare Pharmaceuticals - Lannett announced that it has entered into an agreement with Adare Pharmaceuticals to be the exclusive U.S. distributor of Dexmethylphenidate Hydrochloride extended release, or ER, capsules. Lannett expects to commence marketing within a few months. Dexmethylphenidate Hydrochloride ER Capsules has an estimated IMS market value of approximately $620 million, although actual generic market values are expected to be lower. Under the agreement, Lannett will primarily provide sales, marketing and distribution support for the product, for which it will receive a percentage of the net profits. Other financial terms were not disclosed.
WFT

Hot Stocks

06:56 EDT Weatherford announces sale of laboratory service business for $205M in cash - Weatherford announced it has signed a definitive agreement to sell its laboratory services business to a group led by CSL Capital Management for $205M in cash. Under the agreement, Weatherford will divest its laboratory and geological analysis business, including personnel and associated contracts. After exiting the laboratory business, Weatherford will continue to maintain a close, collaborative relationship with CSL Capital that will enable it to continue to provide services to their joint customers. The transaction is expected to close before year-end, subject to regulatory approvals, consents and other customary closing conditions. The transaction is subject to a customary post-closing working capital adjustment. Upon closing, Weatherford will use the proceeds to reduce its debt. This transaction is one in a series of planned divestitures intended to maximize Weatherford shareholder value by refocusing the company's portfolio on core businesses most closely aligned with its long-term strategy and to reduce its debt.
ARII

Hot Stocks

06:56 EDT American Railcar trading halted, news pending
EXEL

Hot Stocks

06:55 EDT Exelixis reports Phase 1b results of cabozantinib combination in carcinoma - Exelixis announced results from the dose-escalation stage of the phase 1b COSMIC-021 study of cabozantinib in combination with atezolizumab in previously untreated advanced renal cell carcinoma. The primary objective of the dose-escalation stage of the trial was to determine the recommended dose of cabozantinib in combination with the standard dose of atezolizumab for the expansion stage of the trial. The findings demonstrate 'encouraging' clinical activity for the combination, supporting further evaluation of the 40 mg dose of cabozantinib in combination with the standard dose of atezolizumab in the ongoing expansion phase of the trial. The findings were presented at the European Society for Medical Oncology 2018 Congress in Munich. Twelve patients with previously untreated advanced RCC including ten patients with clear cell RCC and two patients with non-clear cell RCC were treated in the dose-escalation stage. As of August 21, all patients remained on treatment. Median follow-up was 33.4 weeks. 80% clear cell RCC patients achieved a response per RECIST 1.1. Among all 12 patients enrolled, the response rate was 67%. The disease control rate for all 12 patients was 100%. No dose-limiting toxicities or serious adverse events were noted at either cabozantinib dose.
MRK

Hot Stocks

06:51 EDT Merck's Keytruda receives positive opinion from EMA in melanoma - Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Keytruda, Merck's anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with melanoma with lymph node involvement who have undergone complete surgical resection. This recommendation is based on data that demonstrated a significant improvement in recurrence-free survival for Keytruda in the pivotal Phase 3 EORTC1325/KEYNOTE-054 trial. The CHMP's recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A final decision is expected in Q4.
BMY

Hot Stocks

06:49 EDT Bristol-Myers' Opdivo combination shows longer survival in renal cell carcinoma - Bristol-Myers announced the results of a new analysis from the Phase 3 CheckMate -214 study, demonstrating that therapy with Opdivo plus Yervoy in patients with previously untreated advanced or metastatic renal cell carcinoma was associated with significantly longer treatment-free survival. With a minimum follow-up of 30 months, 36% of patients who received Opdivo plus Yervoy were still alive and not requiring subsequent therapy vs. 16% of patients who received sunitinib. At two years in patients who discontinued therapy, 19% of Opdivo plus Yervoy patients vs. 6% of sunitinib patients remained treatment free. TFS was significantly longer with Opdivo plus Yervoy vs. sunitinib regardless of best overall response. Two years after discontinuation, 42% of patients treated with the combination vs. 12% on sunitinib with complete or partial responses remained free of subsequent treatment; at the same time point, 12% of combination-treated patients and 6% of sunitinib patients with stable disease remained treatment free.
MNK

Hot Stocks

06:49 EDT Mallinckrodt to report interim data on H.P. Acthar Gel Phase 4 study at ACR/ARHP - Mallinckrodt is reporting interim data at the midway point of enrollment in the ongoing Phase 4, multicenter study assessing the efficacy and safety of H.P. Acthar Gel in patients with persistently active rheumatoid arthritis, or RA, despite receiving disease-modifying anti-rheumatic drugs, or DMARDs, and corticosteroids. The data will be reported in a poster presentation at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals, or ACR/ARHP. Acthar Gel is FDA approved as adjunctive therapy for short-term administration in RA including juvenile RA. The study is a Phase 4, multicenter, two-part study assessing the efficacy and safety of H.P. Acthar Gel in adult subjects with rheumatoid arthritis with persistently active disease despite treatment with DMARDs and corticosteroids. The primary endpoint of the study is the proportion of patients reaching low disease activity, or LDA, at 12 weeks. In this interim analysis at the midway point of study enrollment, researchers found that 61% of the 100 patients who had completed the open-label period achieved LDA at 12 weeks.
HAL

Hot Stocks

06:47 EDT Halliburton CEO says 'pleased with our overall financial results' for Q3 - "I am pleased with our overall financial results for the third quarter. Our team optimized our performance in North America in the face of short-term challenges, and the recovery of our international operations continued," commented Jeff Miller, President and CEO. "Total company revenue of $6.2 billion was essentially flat quarter over quarter, while operating income was $716 million, a 9% decrease compared to the second quarter of 2018, largely due to the softening North America market for completion services. "In North America, a combination of offtake capacity constraints and our customers' budget exhaustion led to less demand than expected for completion services. I believe that these are temporary issues, and that the catalysts for improving demand for services are clearly visible: supportive commodity pricing, expanding offtake capacity, building well inventory, and reloaded customer budgets. "Our international business continues to show signs of a steady recovery, with revenue increasing 5% sequentially, and every international region growing this quarter. "In both of our divisions, we continue to invest in technologies and capabilities that we believe will drive growth, create meaningful differentiation, and deliver industry-leading returns. As a result, we are able to provide cutting edge technology that sets new standards for service quality and performance, and makes better wells for our customers. "The outlook for global commodity supply and demand dynamics is constructive. I am confident that Halliburton has the right strategy, technology, and services to deliver industry-leading returns. We remain the leader in North America, which we believe is poised for a better 2019, and Halliburton is better positioned than it has ever been for the international recovery," concluded Miller.
NCNA

Hot Stocks

06:45 EDT NuCana PLC (ADS) trading halted, news pending
HAS

Hot Stocks

06:37 EDT Hasbro sees $50M-$60M in charges in Q4 due to organizational steps - As part of the company's ongoing efforts to compete in an evolving marketplace, Hasbro is undertaking organizational steps to ensure it has the right talent and capabilities to profitably grow going forward. The company expects to incur pre-tax cash restructuring charges relating to severance and other employee costs of approximately $50M-$60M, that will be expensed in the fourth quarter of 2018. The company expects cash payments to be made from October 2018 through December 2019. As a result of these steps, the company expects to generate approximately $30M-$40M in annualized pre-tax savings by 2020.
HCHC

Hot Stocks

06:35 EDT HC2 Holdings to explore strategic alternatives for Global Marine subsidiary - HC2 Holdings announced that it is exploring strategic alternatives, including a potential sale, for its Global Marine subsidiary. As part of this process, Global Marine Holdings, LLC, a leading provider of offshore engineering services to the telecommunications, renewables and oil & gas industries through its operating subsidiary Global Marine Systems Limited, has engaged Deutsche Bank Securities and ABN AMRO Bank as joint advisors to explore strategic alternatives for the business. "We very much welcome this decision from HC2 to explore strategic options to support the continued growth of the Global Marine Group platform," said Ian Douglas, Chief Executive Officer of Global Marine. "Together, we have strengthened the business and grown across our target markets, and we believe we have a great opportunity to accelerate our growth with our experienced and proven management team, strong balance sheet, enhanced and upgraded portfolio of marine assets and a solid pipeline of secured and potential project opportunities." There can be no assurance that the exploration of any strategic alternative, including a potential sale, will result in a consummated transaction or other alternative. Neither HC2 nor Global Marine has set a timetable for completion of the process, and neither intends to comment further regarding the process unless a specific transaction or other alternative is approved by their respective Boards of Directors, the process is concluded or it is otherwise determined that further disclosure is appropriate or required by law.
KMPR

Hot Stocks

06:34 EDT Kemper sees Q3 pre-tax catastrophe losses of $20M-$25M - Kemper anticipates Q3 results will include several items, some of which are one-time in nature: a tax benefit of $20M-$30M as a result of an updated analysis of certain provisional amounts recorded for the effect of the Tax Cuts and Jobs Act on Kemper's deferred income tax assets and liabilities; transaction and integration expenses of $15M-$20M pre-tax in connection with the acquisition of Infinity Property and Casualty Corporation on July 2; Kemper's results for Q3 will include Infinity's results from the date of acquisition and forward; and pre-tax charge of approximately $9M for lease termination and other costs associated with the relocation of Kemper's corporate headquarters. Q3 results will also include a pre-tax gain of $35.7M related to the partial satisfaction of a judgment in its favor.
HAS

Hot Stocks

06:33 EDT Hasbro CEO says managing 'through a very disruptive year' - "The global Hasbro team is effectively managing our business forward through a very disruptive year," said Brian Goldner, Hasbro's chairman and CEO. "The lost Toys"R"Us revenues are impacting many markets around the world, notably the U.S., Europe, Australia and Asia. The volume of product liquidated in the second quarter had a near-term impact on the third quarter sell through and shipments. We are successfully managing retail inventory and it is down significantly in the U.S. and in Europe, where we are aggressively working to clear excess inventory by year end. A growing array of retailers are now ramping new programs to take share this holiday season and we are well positioned to meet their demand. "We continue to make meaningful organizational changes to ensure we have the right teams in place with the right capabilities to lead Hasbro into the future," continued Goldner. "Global retailers have ambitious programs this holiday season and we have innovative brand offerings across the portfolio, including programs behind our feature TRANSFORMERS film, Bumblebee, set for release this holiday season. Our long-term commitment to building capabilities around our Brand Blueprint coupled with industry-leading investment in innovation positions us for a successful holiday season and beyond." "Hasbro remains in a strong financial position, including good operating profit margins, $907 million in cash and quality inventory to support our business this holiday season," said Deborah Thomas, Hasbro's chief financial officer. "As we manage through a very disruptive environment, the strength of our brands and our business allows us to continue to invest to drive profitable growth in future years."
BEDU

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06:33 EDT Bright Scholar to acquire 85% interest in eight kindergartens for RMB70.55M - Bright Scholar announced that it signed an agreement to acquire an 85% equity interest in a company managing a chain of eight kindergartens in Shandong province, China for a total consideration of RMB70.55M. The target kindergartens had a total capacity of 2,310 students with a blended utilization rate of 66.7% as of June 30 and the average tuition for the target kindergartens was about RMB18,000 per year in 2017. The company targets to close the transaction in the first half of FY19, subject to the satisfaction of customary closing conditions and the completion of relevant corporate and regulatory procedures.
HAS

Hot Stocks

06:32 EDT Hasbro reports Q3 U.S. and Canada segment revenues down 7% - Reports Q3: U.S. and Canada segment revenues down 7%; International segment revenues down 24%; Entertainment and Licensing revenues up 45%; Operating profit margin of 20.0% versus 20.1% in third quarter 2017.
HCHC

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06:25 EDT HC2 Holdings: FDA grants Breakthrough Device designation to MediBeacon's TGFR - HC2 Holdings announced that the U.S. FDA has granted Breakthrough Device designation to MediBeacon, a portfolio company within HC2's Pansend Life Sciences subsidiary, for the company's Transdermal GFR Measurement System. The device is intended to measure Glomerular Filtration Rate in patients with impaired or normal renal function.
HCLP

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06:25 EDT Hi-Crush Partners completes buyout of general partner for $96.25M - Hi-Crush Partners has acquired its general partner by acquiring Hi-Crush Proppants for consideration of 11.0 million newly issued common units of the Partnership. Total value of the consideration for the acquisition, comprised entirely of the newly issued units, is $96.25M based on Friday's closing price of $8.75 per unit. Through the acquisition, which closed on October 21, Hi-Crush simplified its corporate structure, eliminating its incentive distribution rights and associated reset provisions, and acquiring the non-economic general partner interest in the Partnership. Six members of the board of Directors have resigned, including those seats previously held by Avista Capital Partners and its appointees. The current board consists of the three independent directors and Hi-Crush CEO Robert Rasmus, elected chairman. The Partnership expects to elect new members to its Board of Directors, including additional independent directors, and to hold meetings for the public election of directors in the future. Hi-Crush CFO Laura Fulton stated "The 100% equity financed buyout of our general partner provides us with additional flexibility as we continue to execute on our growth program, and accelerates our pathway to corporate conversion, likely during 1H19. Using equity for the transaction and eliminating cash distributions that would have been associated with the IDR reset path's requirement of three additional quarters of distributions above $0.7125 per unit allows us to conserve cash and strengthen the balance sheet going forward, in what today is a softer market environment."
HCLP

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06:23 EDT Hi-Crush Partners cuts quarterly cash distribution to 22.5c per unit - The Partnership announced that the Board of Directors, comprised of the current four members, has declared a quarterly cash distribution of 22.5c per unit on all common units, or 90c on an annualized basis, for the third quarter of 2018, compared to a previous quarterly cash distribution of 75c per unit. The distribution will be paid on November 14, 2018, to all common unitholders of record on November 1, 2018.
PZZA

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06:21 EDT John Schnatter urges Papa John's board to change poison pill - John Schnatter, who currently owns 30.9% of Papa John's outstanding common stock, delivered a letter to the company's board communicating his concerns about the Rights Plan and requesting that the board amend the Rights Plan. The letter states in part, "Specifically, I request that you promptly amend the Poison Pill to remove or otherwise render inapplicable the 'Acting in Concert' provisions of the Poison Pill. As you know, no Delaware court ever has found that this type of 'wolfpack' provision in a poison pill is consistent with Delaware law. In fact, this provision goes far beyond Delaware law by unreasonably curtailing the rights and legitimate interests of shareholders. Among other things, it precludes shareholders from holding any substantive discussions about the Company because of the threat of crippling dilution of their ownership interest in the Company. Prompt removal of this provision is important. Per media reports, the Special Committee's process to consider acquisition proposals or other strategic transactions has already elicited at least one potential investor. In addition, there surely are other shareholders who wish to engage with their fellow shareholders about the Company. Several third parties have expressed an interest in speaking with me. The 'Acting in Concert' provision, however, precludes me from discussing the Company, my investment in the Company or the activities or plans of potential investors or shareholders with them or anyone else with an interest in the Company. I believe that preventing me from discussing such matters will lead to significant loss of value for all shareholders and is in plain contravention of your duties under Delaware law...Among other things, the leadership changes which have occurred over the past several weeks are cause for deep concern for the future of the Company and its direction. The leadership team that Steve Ritchie established is crumbling, and now he is promoting the wrong people and losing long-term employees who provided the essence of what Papa John's was created to do - provide customers with better ingredients and better pizza. The Board must cease this ongoing infringement on shareholders' rights through an amendment to the Poison Pill making clear that the Board has no authority to preclude its shareholders from conversing freely and fully regarding the Company, the issues the Company faces and the Company's future. As time is of the essence, please respond by the close of business on October 23, 2018. If I do not receive a response by that time, I reserve all rights to take any action to ensure the Company permits the shareholders to exercise their rights."
MRTX

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06:21 EDT Mirati Therapeutics presents updated data on sitravatinib with Opdivo study - Mirati Therapeutics announced the presentation of updated data from its ongoing Phase 2 clinical trial of sitravatinib in combination with Opdivo in non-small cell lung cancer, or NSCLC, patients with documented progression on prior immune checkpoint inhibitor therapy. The data were presented today in a proffered paper session at the European Society for Medical Oncology, or ESMO. An ongoing Phase 2 study is evaluating the efficacy and safety of sitravatinib in combination with Opdivo, an anti-PD-1 immune checkpoint inhibitor, in patients with NSCLC who have experienced documented disease progression following prior treatment with an immune checkpoint inhibitor.
SVA

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06:19 EDT Sinovac Biotech granted interim injunctive relief in falsified documents - Sinovac Biotech senior management and the lawful directors of Sinovac Hong Kong, Yin Weidong and Wang Nan, have been granted interim injunctive relief against Li Pengfei and Cao Jianzeng by the High Court of the Hong Kong Special Administrative Region. The interim injunction was granted in the proceedings brought by the Lawful Directors to nullify and remove forged documents that were illegally filed with the Hong Kong Companies Registry in respect of Sinovac Biotech Hong Kong. "These forged documents were used to unlawfully remove the Lawful Directors of Sinovac HK's subsidiary, Sinovac Biotech Co., and to deceive the Industry and Commerce Bureau of Beijing into believing that the board of Sinovac Beijing had been reconstituted". Li and Cao were given prior notice of the hearing but did not appear in Court to respond to the proceedings. At the hearing, the Judge granted an interlocutory injunction in the same terms sought by the Lawful Directors restraining Li and Cao from purporting to act or holding themselves out as directors of Sinovac HK or its subsidiaries. The Board of Directors and management of publicly traded Sinovac, which remain unchanged by the unauthorized actions of Sinobioway and the Dissident Shareholders, are closely monitoring these unauthorized actions purportedly taken at Sinovac HK and Sinovac Beijing.
ENLC ENLK

Hot Stocks

06:17 EDT EnLink Midstream to acquire EnLink Midstream Partners - The EnLink Midstream companies, EnLink Midstream (ENLC) and EnLink Midstream Partners (ENLK) announced that they entered into a merger agreement whereby ENLC will acquire all outstanding common units of ENLK not already owned by ENLC in a unit-for-unit exchange transaction to simplify its corporate structure. The transaction is expected to close in Q1 of 2019, and upon closing, EnLink will continue to operate as ENLC, a leading midstream energy provider with service offerings across key supply basins and demand regions in the United States. At closing, the pro forma company will retain the name EnLink Midstream and will continue to trade on the New York Stock Exchange as ENLC. Under the terms of the merger agreement, ENLK common unitholders will be entitled to receive 1.15 common units of PF ENLC for each common unit of ENLK owned. In connection with the transaction, ENLC's incentive distribution rights, or IDRs, in ENLK will be eliminated. The transaction was approved by the conflicts committees and boards of both ENLC and ENLK. Under the terms of the agreement, ENLC will acquire 100% of the outstanding ENLK common units that it does not already own. ENLK common unitholders will be entitled to receive 1.15 units of PF ENLC per ENLK unit owned. The consideration for ENLK common unitholders represents a premium of 3.5% based on the volume weighted average price for both securities over the last 30 trading days. As part of the simplification, PF ENLC will eliminate all IDRs in ENLK. EnLink's Series B Preferred Units, Series C Preferred Units, and senior notes will continue to remain outstanding at ENLK. PF ENLC will have approximately 490 million fully diluted units outstanding at transaction close. The transaction results in a tax basis step-up for PF ENLC with respect to the assets of ENLK. The step-up in tax basis will enhance PF ENLC's tax outlook and is expected to result in minimal income taxes through at least 2023. The transaction is expected be taxable to ENLK common unitholders, who are encouraged to consult with their tax advisor regarding the potential tax impact from the transaction. Concurrent with the execution of the merger agreement, an affiliate of GIP that owns a majority of outstanding ENLC common units executed a written consent to approve such issuance. This consent satisfied the requisite approval of the ENLC unitholders for the issuance by ENLC of common units in the transaction. The transaction is subject to the approval of holders of a majority of the ENLK common units. As part of the transaction, GIP, ENLC, and certain subsidiaries of ENLC entered into a support agreement agreeing to vote in favor of the transaction. The transaction is expected to close in Q1 of 2019, subject to obtaining the ENLK unitholder approval, customary regulatory approvals, and other customary closing conditions. The transaction creates a $13B enterprise value company upon closing. It also simplifies the organizational structure into a single, larger publicly traded midstream energy company, increasing the public float and enhancing trading liquidity. The deal improves project returns with a lower cost of capital for the pro forma entity. The deal also delivers immediate accretion to distributable cash flow per unit for both ENLC and ENLK unitholders.
YNDX

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06:12 EDT Yandex addresses market rumors on capital structure - Yandex acknowledged "recent media speculation about potential changes to our capital structure (...) In the normal course of business, the Board of Directors and its relevant committees periodically consider questions relating to the optimal capital structure of our company (...) It should also be noted that any corporate actions affecting the rights of holders of any class of shares are subject to robust governance policies, which include not only Board approval, but also the approval of holders of 75% of the company's Class A shares. Arkady Volozh, the company's CEO and co-founder, currently holds Class B shares representing approximately 48% of the votes of the company and approximately 10% of the economic interest. Mr. Volozh and other founders and early employees, who also own Class B shares, together currently hold approximately 57% of the total voting power in the company (...)" CEO Volozh commented, "I have no intention to sell my shares in the company. I support the Board's efforts to continuously evaluate the company's capital structure to best position the company for the future." Board deliberations may or may not lead to any proposal to change the company's capital structure or to any potential transaction, and the company does not intend to comment further on market speculation or disclose any developments unless and until it otherwise deems further disclosure is appropriate or required.
ENLC ENLK

Hot Stocks

06:07 EDT EnLink Midstream to acquire EnLink Midstream Partners in unit-for-unit deal
RDWR

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06:06 EDT Radware selected by global SaaS company for hybrid DDos attack mitigation - Radware announced a multi-million-dollar deal for DDoS Protection Services with a Tier 1 SaaS organization. The purchase layers cloud DDoS on top of Radware on-premises attack mitigation to provide a hybrid defense solution. Radware's Hybrid Defense Messaging provides critical information from the on-premises devices to Radware's Emergency Response Team, for near instantaneous detection and switchover in the face of a complex attack.
PII

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06:04 EDT Polaris Industries says FY18 guidance includes $40M of tariff cost increases - The full year earnings guidance includes approximately $40M of tariff cost increases before counter-measures, as the company understands them currently.
NTGN

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06:04 EDT Neon Therapeutics presents Phase 1b data on NEO-PV01 vaccine - Neon Therapeutics presented updated data from NT-001, its ongoing Phase 1b clinical trial evaluating NEO-PV-01 in the metastatic setting, at the European Society for Medical Oncology Congress in Munich. NEO-PV-01 is a personal neoantigen vaccine custom-designed and manufactured based on the unique mutational fingerprint of each individual patient. NT-001 is a Phase 1B study evaluating NEO-PV-01 in combination with nivolumab in both checkpoint naive first and later-line treated patients with metastatic melanoma, smoking-associated, non-small cell lung cancer or bladder cancer. The primary endpoint of the study is safety. Exploratory endpoints include both neoantigen-specific immune responses as well as post-vaccine clinical responses, clinical response durability and correlation between immune and clinical findings. Neon's President of Research and Development of Therapeutics Richard Gaynor, said,"Today's dataset, in addition to demonstrating safety and tolerability, represents a positive evolution of the clinical results, notably in the form of post-vaccine responses and patients remaining on treatment. Importantly, these data build upon the growing body of evidence for the immune mechanism underlying these outcomes. While still early, this is clearly a promising dataset and we look forward to how these results evolve over time."
DBVT

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05:58 EDT DBV submits Biologics License Application to FDA for Viaskin Peanut - DBV Technologies announced the submission of a Biologics License Application to the FDA for Viaskin Peanut for the treatment of peanut allergy in children four to 11 years of age. Viaskin Peanut is the company's lead product candidate, which is based on epicutaneous immunotherapy, a proprietary technology platform that delivers biologically active compounds to the immune system through the skin. "This submission represents a significant step forward for those families living with peanut allergy. We are thankful for the patients, investigators and DBV employees' efforts in making this milestone possible," said Dr. Pierre-Henri Benhamou, CEO of DBV Technologies. "We have been developing Viaskin Peanut for over 10 years, with over 1,000 patients studied in our clinical trials, and we are excited about the possibility of helping patients suffering from peanut allergy." Viaskin Peanut previously received Breakthrough and Fast Track Designation from the FDA in 2015 and 2012, respectively.
EPZM

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05:56 EDT Epizyme says tazemetostat showed clinically meaningful activity in ES patients - Epizyme announced positive interim data from the fully enrolled epithelioid sarcoma cohort of its ongoing Phase 2 study of its lead candidate tazemetostat, a potent, selective, orally available EZH2 inhibitor. The data were presented by the study's lead investigator, Mrinal Gounder, M.D., attending physician, Sarcoma Medical Oncology and Early Drug Development Services, Memorial Sloan Kettering Cancer Center, during the European Society for Medical Oncology 2018 Congress in Munich, Germany. Interim data as of August 21, 2018 from the 62 patients enrolled show that tazemetostat treatment demonstrated clinically meaningful activity for patients with epithelioid sarcoma, or ES. Oral, twice daily administration of tazemetostat resulted in durable objective responses and encouraging overall survival in both treatment-naive patients and patients who had been previously treated with an anticancer therapy. In addition, tazemetostat was generally well-tolerated.
ACIU

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05:54 EDT AC Immune Chief Scientific Officer Dr. Andreas Muhs to take medical LOA - AC Immune announced that Dr. Andreas Muhs, Chief Scientific Officer, will take a medical leave of absence, starting immediately. During the leave of absence, AC Immune's research team will be led by Dr. David Lowe on an interim basis. Dr. Lowe has served as AC Immune's Deputy Chief Scientific Officer and more recently as Innovation Fellow since January 2014. While he is on medical leave, Dr. Muhs will stay involved with AC Immune's research team to the extent practical, and he will re-assume his role as soon as he has recovered.
CLGN UTHR

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05:53 EDT CollPlant, United Therapeutics announce licensing and commercialization deal - CollPlant (CLGN) and United Therapeutics (UTHR) announced that they have entered into a license, development and commercialization agreement for 3D bioprinted lung transplants. The agreement combines CollPlant's proprietary recombinant human collagen and BioInk technology with the regenerative medicine and organ manufacturing capabilities of United Therapeutics. Under terms of the agreement, CollPlant granted United Therapeutics, through its wholly owned organ manufacturing and transplantation-focused subsidiary Lung Biotechnology PBC, an exclusive license to its technology for the production and use of rhCollagen-based BioInk for 3D bioprinted lung transplants throughout the universe. CollPlant will manufacture and supply BioInk for a few years to meet development process demand, and will provide technical support to United Therapeutics as it establishes a U.S. facility for the manufacture of CollPlant's rhCollagen and BioInk. In addition to the initial focus on lung manufacturing, the agreement grants United Therapeutics an option, in its sole discretion, to expand the field of its license to add up to three additional organs. Under financial terms of the agreement, once effective, CollPlant will receive an upfront payment of $5 million and milestone payments of up to $15 million based on the achievement of certain operational and regulatory milestones related to the development of manufactured lungs. The agreement also provides for option exercise payments of up to $9 million, and additional developmental milestone payments of up to $15 million if United Therapeutics elects to develop manufactured organs other than lungs using CollPlant's technology. CollPlant will also be entitled to receive royalties on sales of commercialized products covered by patents licensed from CollPlant, as well as reimbursement for certain costs. Effectiveness of the agreement is subject to certain closing conditions, including receipt of approval of the agreement by the Israel Innovation Authority.
NVS

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05:47 EDT Novartis COMBI-AD study of Tafinlar - Novartis announced a new data analysis of COMBI-AD, a phase III multi-center study evaluating Tafinlar in combination with Mekinist in stage III adjuvant resected BRAF V600-mutant melanoma. With extended study follow up, Tafinlar in combination with Mekinist continued to show more than 50% risk reduction in relapse free survival, or RFS, versus placebo in patients with resected BRAF V600-mutant stage III melanoma. The updated COMBI-AD data was also used to generate a statistical cure-rate model that estimated the fraction of patients who may not relapse. The cure rate was 54% in the Tafinlar + Mekinist arm compared to 37% in the placebo arm. These data were presented at the European Society of Medical Oncology in Munich, Germany and simultaneously published in The Journal of Clinical Oncology. A separate biomarker analysis was conducted to identify predictors of clinical outcome and treatment response. These analyses showed that subgroups of patients at a higher risk of relapse could be defined based on specific immune gene expression signatures and tumor mutation burden.
RHHBY

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05:45 EDT Genentech Tecentriq plus chemo as initial treatment helped people with NSCLC - Genentech, a member of the Roche Group, announced positive results from the Phase III IMpower130 study of Tecentriq plus chemotherapy for the initial treatment of people with previously untreated metastatic non-squamous non-small cell lung cancer, or NSCLC. The analysis showed that Tecentriq plus chemotherapy helped people live significantly longer compared to chemotherapy alone in the intention-to-treat wild-type, or ITT-WT, population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared to chemotherapy alone in the ITT-WT population. Safety for the Tecentriq plus chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.
BMY

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05:33 EDT Bristol-Myers says Opdivo, low-dose Yervoy shows durable clinical benefit - Bristol-Myers announced new data from a cohort of the CheckMate -142 study in which Opdivo plus low-dose Yervoy demonstrated durable clinical benefit as a first-line treatment in patients with microsatellite instability-high, or MSI-H, or DNA mismatch repair deficient, or dMMR, metastatic colorectal cancer, or mCRC. With a median follow-up of 13.8 months, the primary endpoint of investigator-assessed objective response rate, or ORR, was 60%, with a 7% complete response, or CR, rate. Patient responses to the combination treatment were durable; at the time of data cutoff, the median duration of response, or DOR, had not yet been reached and 82% of responding patients had ongoing responses. Among the patients who responded, 74% have had responses lasting more than six months. Patients received Opdivo 3 mg/kg every two weeks plus Yervoy 1 mg/kg every six weeks until disease progression, death or unacceptable toxicity. Grade 3-4 treatment-related adverse events, or TRAEs, occurred in seven patients, and any grade TRAEs leading to treatment discontinuation occurred in three patients. These data from CheckMate -142 will be featured today from 9:15-9:27 CEST in a proffered paper session at the European Society for Medical Oncology 2018 Annual Congress in Munich, Germany and highlighted as part of the ESMO Press Programme.
BHVN

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05:30 EDT Biohaven gets FDA authorization to proceed, doses first subject with BHV-3500 - Biohaven Pharmaceutical announced that the first participant was dosed with BHV-3500, a third generation calcitonin gene-related peptide, or CGRP, receptor antagonist. The initiation of dosing follows Biohaven's filing of an investigational new drug application, or IND, for BHV-3500 in the treatment of migraine and receipt from FDA of authorization to proceed with the clinical investigation of this product candidate. Biohaven's initial clinical trial of BHV-3500 will explore a range of doses using intranasal administration. Intranasal BHV-3500 utilizes the Aptar Pharma Unit Dose System, or UDS, which is designed to enable systemic delivery of drugs without the need for injection or administration by a healthcare professional. This device is approved with multiple drug products marketed in the United States using the Aptar technology and is used by thousands of people every day.
ACN

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05:25 EDT Accenture acquires DAZ Systems, terms not disclosed - Accenture has acquired DAZ Systems. The acquisition further bolsters Accenture's robust Oracle capabilities and delivers new value for clients on their journeys to the cloud. Financial terms of the acquisition were not disclosed.
FCAU KKR

Hot Stocks

05:24 EDT Fiat Chrysler confirms sale of Magneti Marelli to Calsonic Kansei for EUR 6.2B - Fiat Chrysler Automobiles (FCAU) announces that it has entered into a definitive agreement to sell its automotive components business Magneti Marelli S.p.A. to CK Holdings, a holding company of Calsonic Kansei, a wholly owned portfolio company of KKR (KKR). Following the closing of the Transaction, CK Holdings will be renamed as Magneti Marelli CK Holdings*. The combined businesses of Calsonic Kansei and Magneti Marelli will create the world's 7th largest global independent automotive components supplier based on total revenues. The agreement represents a transaction value of EUR 6.2B. The Transaction is expected to close in the first half of 2019 and is subject to regulatory approvals and other customary closing conditions. The Transaction represents a unique opportunity to combine two successful businesses to create one of the leading global independent automotive components suppliers, with combined revenues of EUR 15.2B. The combination is a decisive step towards both companies' strategic ambition to become a leading globally-diversified tier-one supplier. The combined company will be well positioned to serve its customers around the world due to its enhanced scale, financial strength and the highly complementary nature of its combined product lines and geographic footprint. The new entity will operate out of nearly 200 facilities and R&D centers across Europe, Japan, the Americas, and Asia Pacific. FCA has also agreed to a multi-year Supply Agreement that will further strengthen a mutually beneficial relationship for both Magneti Marelli and FCA's expanding model range and which will sustain Magneti Marelli's Italian business operations, positioning it strongly for continued growth and success in the future. The combined company will be led by Beda Bolzenius, currently CEO of Calsonic Kansei, based in Japan. Ermanno Ferrari, CEO of Magneti Marelli, will join the Magneti Marelli CK Holdings board.
FCAU

Hot Stocks

05:21 EDT Fiat Chrysler confirms sale of Magneti Marelli to Calsonic Kansei for EUR 6.2B