Stockwinners Market Radar for October 08, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:01 EDT Talend adds new Asia-Pacific cloud infrastructure - Talend announced it is supporting Talend Cloud's expansion and growth in Asia Pacific with new regional cloud data infrastructure. With growth exceeding 100% year over year in APAC, Talend is helping the region's enterprises put more diverse data, applications and APIs to work while addressing data privacy, residency and performance requirements. Talend Cloud provides a single platform for data integration across cloud and on-premises environments and allows for greater collaboration between IT and business teams.

18:44 EDT Arcus Biosciences to present Phase 1 AB928 study at ESMO - Arcus Biosciences announced that it will present final results from the Phase 1 study of AB928, its dual adenosine receptor antagonist, in healthy volunteers during a poster display session at the European Society of Medical Oncology 2018 Congress, being held October 19-23, 2018, in Munich, Germany. The safety data to be presented will demonstrate that in this study, there was no evidence of the physiological effects of blocking adenosine that have been observed clinically with earlier adenosine receptor antagonists. Physiological effects associated with the earlier adenosine receptor antagonists that were initially designed for CNS indications may potentially limit their optimal dosing in the oncology setting. The pharmacokinetic and pharmacodynamic correlations generated from this study, which will be described in the poster presentation, were used to guide dose selection in the Company's four Phase 1/1b trials in patients.

18:19 EDT Adaptimmune to present updates from MAGE-A10 studies at ESMO - Adaptimmune Therapeutics announced further details about two poster presentations at the upcoming ESMO congress. Brief summary of abstract included Background: Ongoing study to evaluate safety and tolerability of SPEAR T-cells directed towards a MAGE-A4 peptide expressed on tumors in the context of HLA-A*02; Results : Three patients were treated with 100 M MAGE-A4 SPEAR T-cells, and transduced cells were detectable in peripheral blood; Adverse events (AEs) for the first 2 patients reported at grade greater than or equal to3 included anemia, hypoglycemia, hyponatremia, lymphopenia, neutropenia, and thrombocytopenia; Serious AEs included G4 hyponatremia, G3 atrial fibrillation, G3 syncope (unrelated to T-cell therapy), G1 CRS and G2 encephalopathy syndrome (both related), and G2 generalized muscle weakness (possibly related); None of the events were considered dose limiting toxicities by the Safety Review Committee; Conclusions: MAGE-A4 SPEAR T-cells at the 100 M transduced cell dose appear to show no evidence of on-target or off-target toxicity; Preliminary data support continued investigation of the T-cell receptor, and this trial is ongoing.

18:06 EDT Eli Lilly to present new data at ESMO showcasing cancer care advances - Eli Lilly will present new data from its clinical development program at the European Society for Medical Oncology 2018 Congress in Munich, Germany, October 19-23. Data presented showcase how Lilly is taking a global, patient-centric research approach to drive advances in cancer care. Data include presentations on abemaciclib, pemetrexed and ramucirumab, as well as investigational compound pegilodecakin - used as a single agent and in combination with chemotherapy and with checkpoint inhibitor therapy - across multiple tumor types. Pegilodecakin joined the Lilly Oncology pipeline with the company's acquisition of ARMO BioSciences earlier this year. Key abemaciclib data include findings from the Phase 3 MONARCH 2 trial evaluating abemaciclib plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Additionally, results will be presented from Lilly's ongoing immuno-oncology clinical collaboration with Merck (known as MSD outside the U.S. and Canada) on the KEYNOTE-189 trial evaluating pemetrexed plus platinum chemotherapy in combination with pembrolizumab in the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). Ramucirumab data include Phase 3 findings from several patient populations with aggressive disease such as the REACH-2 study of ramucirumab as a single agent in the second-line treatment of people with hepatocellular carcinoma (HCC), also known as liver cancer, and the RANGE study evaluating ramucirumab in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. Pegilodecakin data include new results from an early-phase study in patients with renal cell, non-small cell lung, pancreatic, ovarian and breast cancers.

17:35 EDT OMA Airports reports September passenger traffic up 14.9% from last year - Grupo Aeroportuario del Centro Norte, S.A.B. de C.V., known as OMA, reports that terminal passenger traffic at its 13 airports increased 14.9% in September 2018, as compared to September 2017. Domestic traffic increased 16.2%, and international traffic increased 4.5%.

17:29 EDT Blackbaud down 12.5% afterhours following a cut in its FY18 guidance

16:55 EDT PPG down 5.9% after below-consensus outlook for Q3 and Q4 earnings

16:47 EDT Affimed N.V. down over 25% following resumption of trade

16:45 EDT Affimed NV trading resumes

16:34 EDT Air Lease announces delivery of Boeing 787-9 aircraft to Air Tahiti Nui - Air Lease (AL) announced the delivery of the first of two new Boeing (BA) 787-9 aircraft on long-term lease to Air Tahiti Nui. This Dreamliner aircraft is from ALC's order book with Boeing and is powered by GEnx-1B74/75 engines.

16:31 EDT Franklin Resources reports preliminary AUM $717.1B as of September 30 - Compared to $722.4B at August 31, 2018. The decrease in assets under management was attributable to net outflows and net market change and other. Preliminary average assets under management for the quarter ended September 30, 2018, were $724.3B.

16:20 EDT Edwards announces start of U.S. study of Centera transcatheter valve - Edwards Lifesciences announced that it has commenced the U.S. pivotal trial that will study its self-expanding CENTERA transcatheter valve for severe, symptomatic aortic stenosis, AS, patients at intermediate risk of open-heart surgery. "We are pleased to launch this rigorous study, which we believe will build a robust body of evidence to support the use of this feature-rich, self-expanding valve system in the treatment of patients with aortic stenosis," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "We look forward to demonstrating the safety and effectiveness of this advanced transcatheter system." Separately, Edwards confirmed it has updated its regulatory filings and is now resuming the commercial introduction of the CENTERA valve in Europe after completing the previously announced minor modification to CENTERA's delivery system. The CENTERA valve was approved in Europe in February 2018 for the treatment of high-risk patients suffering from severe, symptomatic AS. The CENTERA valve is not approved for commercial sale in the U.S.

16:19 EDT FDA puts Affimed N.V.'s AFM11 phase 1 program on hold following death of patient - Affimed N.V. announced that it has placed AFM11 (CD19/CD3-targeting T cell engager) on clinical hold, and has notified the global health authorities of its decision. AFM11 is being evaluated in two Phase 1 clinical studies for the treatment of patients with relapsed or refractory CD19 positive B-cell non-Hodgkin lymphoma and acute lymphoblastic leukemia (ALL). The clinical hold was initiated after the occurrence of Serious Adverse Events in three patients, which included a death in the ALL study and two life-threatening events in the NHL study. The SAEs occurred in patients enrolled in the highest dose cohorts of each study. Thirty-three patients have been treated in total in the two Phase 1 studies, with preliminary signs of clinical activity observed in several patients. Affimed will be working closely with the global health authorities, the Safety Monitoring Committees, and the studies' clinical investigators to review the events, carefully assess all of the data and determine next steps for the AFM11 program. Affimed intends to provide an update on AFM11 upon completion of the evaluation. The clinical hold does not affect the ongoing development of Affimed's NK cell engager programs, which are based on targeting the NK cell receptor CD16A, a different approach than used for AFM11, which targets T cells through CD3.

16:16 EDT USA Technologies announces receipt of Nasdaq listing notice - USA Technologies announced that it has received a notice from The NASDAQ Stock Market LLC notifying the Company that, as a result of its failure to timely file its Annual Report on Form 10-K for the fiscal year ended June 30, 2018 (the "Annual Report"), the Company is noncompliant with Nasdaq Listing Rule 5250(c)(1). Nasdaq Listing Rule 5250(c)(1) requires listed companies to timely file all required periodic financial reports with the Securities and Exchange Commission. The notice provides that the Company has until November 1, 2018 to submit to Nasdaq a plan to regain compliance with the Nasdaq Listing Rules. If Nasdaq accepts the Company's plan, Nasdaq has discretion to grant up to 180 calendar days from the original non-compliance date, or until March 12, 2019, for the Company to regain compliance. The Company will submit a plan to regain compliance within the time period set forth in the notice. If Nasdaq does not accept the Company's plan, the Company will have the opportunity to appeal that decision to Nasdaq's Hearing Panel.

16:10 EDT Veracyte data confirms Envisia Genomic Classifier's ability to aid IPF diagnosis - Veracyte announced the presentation of data demonstrating that the Envisia Genomic Classifier can help physicians more confidently diagnose interstitial lung disease,ILD, including idiopathic pulmonary fibrosis, IPF, without the need for surgery. The data were shared today in an oral presentation at CHEST 2018, the annual meeting of the American College of Chest Physicians, which is being held October 6-10 in San Antonio, Texas..Utilizing histopathology as the reference standard, investigators found that the genomic test shows a specificity of 88 percent and sensitivity of 70 percent for detecting UIP. While high-resolution computed tomography is typically the first step in distinguishing IPF from other ILDs, previous data have shown that up to 50 percent of UIP cases are missed by HRCT alone. Among the 42 cases in the current study with the lowest diagnostic confidence following HRCT - i.e., those without definite or probable UIP - the Envisia classifier provided even more robust results. In August 2018, Veracyte received a draft Medicare coverage policy for the Envisia classifier through the MolDx program. The company expects the final policy will go into effect in early 2019 and plans to expand availability of the test in 2019.

16:10 EDT Hawaiian Airlines revises Q3 RASM view to down 1.5%-down 2.5% - Prior view was flat to down 2%. Narrows Q3 CASM-ex fuel view to up 1%-2% from up 0.5%-3.5%. Sees Q3 gallons of jet fuel consumed up 7%-8% vs. prior view of up 5%-7%.

16:08 EDT Green Brick announces up to $30M share repurchase program - Green Brick announced that the company's board authorized a share repurchase program for the period beginning on October 3 and ending on October 3, 2020 of the company's common stock for an aggregate price not to exceed $30M. The timing, volume and nature of share repurchases will be at the discretion of management and dependent on market conditions, corporate and regulatory requirements and other factors, and may be suspended or discontinued at any time. The authorized repurchases will be made from time to time in the open market, through block trades or in privately negotiated transactions. No assurance can be given that any particular amount of common stock will be repurchased. All or part of the repurchases may be implemented under a rule 10b5-1 trading plan, which would allow repurchases under pre-set terms at times when the company might otherwise be prevented from doing so under insider trading laws or because of self-imposed blackout periods. The company intends to finance the repurchases with available cash and proceeds from borrowings under lines of credit.

16:07 EDT Hawaiian Airlines revises Q3 ASM view to down 1.5%-down 2.5% - Prior view was flat to down 2%. Narrows Q3 CASM-ex fuel view to up 1%-2% from up 0.5%-3.5%. Sees Q3 gallons of jet fuel consumed up 7%-8% vs. prior view of up 5%-7%.

16:07 EDT Century Aluminum announces death of non-executive chairman Wilkinson - Century Aluminum announced the death of its non-executive chairman, Terence Wilkinson, at age 72. Wilkinson joined the Board of Directors as chairman in 2011 and has served in that capacity since that time. He also chaired the Independent Directors and Governance and Nominating committees of the Board. The directors have elected Andrew Michelmore as non-executive chairman.

16:04 EDT Netflix picks Albuquerque for U.S. production hub, in talks to buy ABQ Studios - Governor Susana Martinez, Mayor Tim Keller, and Ty Warren, Vice President, Physical Production for Netflix announced that Netflix has chosen Albuquerque, NM as the site of a new U.S. production hub and is in final negotiations to purchase ABQ Studios, located in Albuquerque's Mesa Del Sol. Upon closing, the company plans to bring $1B dollars in production to New Mexico over the next ten years and create up to 1000 production jobs a year. This is the company's first purchase of a production studio complex.Reference Link

16:03 EDT Hawaiian Airlines reports September traffic up 5.8%, capacity up 9.6% - Load factor decreased 3.0 points to 83.6%. The company has revised its expectations for the quarter ending September 30, 2018, that were previously provided on September 5, 2018. Specifically, for the third quarter, the Company: lowered its expectations for revenue per ASM (RASM) as a result of service disruptions, passenger cancellations and booking interruptions stemming from Hurricane Olivia that affected the Hawaiian island chain in early September, and from Typhoon Jebi that affected Japan in September and resulted in the closure of Osaka's Kansai International Airport for more than 10 days; raised its expectations for gallons of jet fuel consumed due to higher than expected fuel burn in the quarter; and lowered its expectations for costs per ASM (CASM) excluding fuel and special items.

15:59 EDT Delta Apparel subsidiary acquires Silk Screen Ink for $12M - Delta Apparel announced that DTG2Go, LLC, its wholly-owned subsidiary, has acquired substantially all of the assets of Silk Screen Ink, Ltd. d/b/a SSI Digital Print Services, a leading provider of digital print services, for $12M. The acquisition is expected to increase the company's FY19 revenue by approximately $15M and be immediately accretive to diluted earnings per share.

15:36 EDT Fannie Mae appoints Hugh Frater as interim CEO - Fannie Mae announced that it has appointed Hugh Frater as interim CEO. Frater's appointment will be effective on October 16, subject to final FHFA approval. He will succeed Timothy Mayopoulos, who announced his intention to depart in July and will leave the company on October 15.

14:37 EDT Musk retweets Medium post about 'distorting' Tesla press coverage - Tesla CEO Elon Musk retweeted a Medium post by Michael Barnard titled, "Musk and Tesla are doing much better than headlines suggest." Barnard contends, "Media outlets of all types are disproportionately covering every negative story, distorting the narrative around neutral stories and reporting any rumor about Elon Musk they can find...It doesn't take much reading of Musk's actual tweets or Tesla's actual results to see the massive disparity between how Tesla and Musk are portrayed and what they are actually doing." Reference Link

14:06 EDT Alphabet shuts down Google+ for consumers after finding data breach - Google announced on its website that it is shutting down Google+ for consumers. The company explained, "Over the years we've received feedback that people want to better understand how to control the data they choose to share with apps on Google+. So as part of Project Strobe, one of our first priorities was to closely review all the APIs associated with Google+. This review crystallized what we've known for a while: that while our engineering teams have put a lot of effort and dedication into building Google+ over the years, it has not achieved broad consumer or developer adoption, and has seen limited user interaction with apps. The consumer version of Google+ currently has low usage and engagement: 90 percent of Google+ user sessions are less than five seconds. Our review showed that our Google+ APIs, and the associated controls for consumers, are challenging to develop and maintain. Underlining this, as part of our Project Strobe audit, we discovered a bug in one of the Google+ People APIs:Users can grant access to their Profile data, and the public Profile information of their friends, to Google+ apps, via the API. The bug meant that apps also had access to Profile fields that were shared with the user, but not marked as public. This data is limited to static, optional Google+ Profile fields including name, email address, occupation, gender and age. (See the full list on our developer site.) It does not include any other data you may have posted or connected to Google+ or any other service, like Google+ posts, messages, Google account data, phone numbers or G Suite content. We discovered and immediately patched this bug in March 2018. We believe it occurred after launch as a result of the API's interaction with a subsequent Google+ code change. We made Google+ with privacy in mind and therefore keep this API's log data for only two weeks. That means we cannot confirm which users were impacted by this bug. However, we ran a detailed analysis over the two weeks prior to patching the bug, and from that analysis, the Profiles of up to 500,000 Google+ accounts were potentially affected. Our analysis showed that up to 438 applications may have used this API. We found no evidence that any developer was aware of this bug, or abusing the API, and we found no evidence that any Profile data was misused." Shares of Google parent Alphabet are down 1.5%, or $17.69, to $1,150.14 following the disclosure of the breach and a story on it from the Wall Street Journal. Reference Link

13:07 EDT Disney appoints Peter Rice chairman of Walt Disney Television - As part of the integration planning for its pending acquisition of Twenty-First Century Fox (FOXA, FOX), The Walt Disney Company (DIS) announced plans for a new organizational structure for its Media Networks segment, conditional upon closing of the 21st Century Fox transaction. Under the new structure, several 21st Century Fox executives would assume leadership roles at the Disney business segment once the acquisition closes, as 21st Century Fox's businesses are incorporated into Disney. Peter Rice will become Chairman, Walt Disney Television and Co-Chair, Disney Media Networks, reporting directly to Disney CEO Robert Iger. The new organization under Rice will include ABC Television Network, ABC Studios, the ABC Owned Television Stations Group, Disney Channels, Freeform, Twentieth Century Fox Television, FX Networks and FX Productions, Fox 21 Television Studios, and the National Geographic channels. Rice's appointment will take effect upon completion of the acquisition. Rice is currently President of 21st Century Fox and Chairman and CEO of Fox Networks Group. Reporting to Rice will be: Dana Walden, Chairman, Disney Television Studios and ABC Entertainment, John Landgraf, Chairman of FX Networks and FX Productions , Gary Knell, Chairman of National Geographic Partners, Gary Marsh, President and Chief Creative Officer, Disney Channels Worldwide and James Goldston, President, ABC News. Walden's portfolio will include Twentieth Century Fox Television and Fox 21 Television Studios, as well as ABC Entertainment, ABC Studios, Freeform and the ABC Owned Television Stations Group. Walden is currently Chairman and CEO of Fox Television Group. Reporting to Ms. Walden will be: Channing Dungey, President, ABC Entertainment, Patrick Moran, President, ABC Studios, Jonathan Davis and Howard Kurtzman, Presidents of Twentieth Century Fox Television, Bert Salke, President, Fox 21 Television Studios, Tom Ascheim, President, Freeform, and Wendy McMahon, President, ABC Owned Television Stations Group. Ben Sherwood, Co-Chair, Disney Media Networks and President, Disney ABC Television Group, will remain in his current role during the transition period until the acquisition closes.

13:02 EDT BAE Systems to deliver 18 M777 Ultra Lightweight Howitzers to U.S. Army - BAE Systems has received an order to provide 18 additional M777 155mm Ultra Lightweight Howitzers to the U.S. Army under a new contract from the U.S. Department of Defense. This order builds on the more than 1,000 M777 gun systems already in service with the U.S. Army and Marine Corps, as well as logistical support contracts received from the DoD. Work on the contract will begin immediately with support from suppliers across the United States and United Kingdom and the BAE Systems facilities. Deliveries for these additional 18 guns are expected to commence in 2021.

12:16 EDT Lifeway Foods 'applauds' FDA steps to reinforce kefir as dairy product - FDA Commissioner Scott Gottlieb, M.D., has invited comments as part of the agency's process of issuing guidance on the proper labeling of kefir, among other items, as a dairy product. In the request for information, the FDA specifically identified the misuse of kefir, the name of a dairy food, on plant-based product labels. The FDA expressed concern that plant-based products bearing the names of dairy foods are often packaged like their dairy counterparts and often sold in or adjacent to dairy displays in stores, but "may not have the same basic nature, essential characteristics, and characterizing ingredients as their dairy counterparts." In an accompanying news release, Commissioner Gottlieb stated, "consumers should be able to know at a quick glance what type of product they're purchasing for themselves and their families. Implementing clear and transparent food labels and claims is an issue I've made a high priority." The Commissioner reiterated that the FDA will issue guidance that provides greater clarity on appropriate labeling of plant-based products. "I am proud to report that after decades of working with the FDA and Health & Human Services, they have officially sided with us and today started the process of clarifying the proper use of dairy terms, including kefir," said Lifeway Foods CEO Julie Smolyansky. "Kefir is a 2000-year-old product with a rich, storied history and over 100 years of medical research behind it. It is one of the oldest living bacteria and, when fermented in dairy, becomes a special superfood that has survived war and famines."

12:01 EDT T-Mobile launches Metro prepaid service - MetroPCS has officially becomes Metro by T-Mobile (TMUS), launching new all-unlimited rate plans featuring Amazon's (AMZN) Amazon Prime and Google's (GOOG) Google One. Metro by T-Mobile became the first prepaid wireless service provider to commit to 5G service, coming in 2019 as T-Mobile begins launching 5G services and 5G-capable smartphones hit the market.

12:00 EDT Aluminum Corp. of China falls -12.1% - Aluminum Corp. of China is down -12.1%, or -$1.47 to $10.61.

12:00 EDT Azul rises 15.0% - Azul is up 15.0%, or $2.88 to $22.10.

12:00 EDT Pyxus rises 30.4% - Pyxus is up 30.4%, or $8.57 to $36.75.

11:47 EDT Microsoft's LinkedIn announces deal to acquire Glint - Microsoft's LinkedIn unit announced that it has signed an agreement to acquire Glint, which the company identifies as "a leader in employee engagement, that delivers an enterprise-grade platform designed to help organizations do their best work, develop their skills, and improve business results." The company's press release stated: "We believe that LinkedIn with Glint offers a unique opportunity to transform the talent function in a way that will help our customers build great teams through visibility into the people they have, the people they need, and with the means to attract, develop and retain the best talent...We will not be disclosing the financial terms of the deal at this time." Reference Link

11:33 EDT National Beverage affirms LaCroix is 'comprised of natural ingredients' - National Beverage Corp. late Friday affirmed that LaCroix sparkling waters "are comprised of natural ingredients.: The company said in a statement, "There are no synthetic ingredients in LaCroix. Allegations of a recent lawsuit have absolutely no merit and will be proven false in short order. Attention to these charges is an enormous disservice to those who drink and appreciate LaCroix sparkling water. All essences contained in LaCroix are certified by our suppliers to be 100% natural. The lawsuit provides no support for its false statements about LaCroix's ingredients. The United States Food and Drug Administration considers "natural" on a food label to be truthful and non-misleading when 'nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added'. . . that is true with all La Croix products." Michael King, Special Corporate Counsel for National Beverage, stated, "National Beverage emphatically denies all allegations contained in the lawsuit and negative press articles related to it. There are neither sugars nor artificial ingredients contained in, nor added to, our LaCroix products. All of our ingredients are certified as natural." National Beverage shares are down 2%, or $1.85, to $104.41 in late morning trading. Reference Link

11:10 EDT Pacific Ethanol, Gevo continue higher ahead of expected ethanol announcement - President Donald Trump is expected to announce the lifting of a federal ban on summer sales of higher-ethanol blends of gasoline on Tuesday, Reuters reported earlier, citing two sources familiar with the matter. Shares of Pacific Ethanol (PEIX) have surged 19% to $2.23, Gevo (GEVO) is up about 8% and Green Plains (GPRE) has added over 2%.

11:02 EDT Juniper names Eva Andres chief human resources officer - Juniper Networks announced a new appointment to its senior leadership team. Eva Andres has been named SVP, chief human resources officer, reporting to CEO Rami Rahim. Andres is responsible for leading all aspects of Juniper's HR goals, including people strategy, inclusion and diversity efforts, organizational development and enhancement of company culture in order to deliver solutions that will enable business growth. Andres will also lead the management of the Juniper Networks' Foundation Fund. Most recently at Virtustream, Andres brings over two decades of human resources leadership experience to Juniper.

10:49 EDT Linde says proposed Praxair combination gets South Korea antitrust clearance - In accordance with the exchange offer document published on August 15, 2017, Linde announced that the proposed business combination between Praxair (PX) and Linde (LNEGY) received antitrust clearance in South Korea subject to certain conditions, satisfying a closing condition. Linde is a public limited company formed on April 18, 2017, that will become the parent company of Praxair and Linde upon the completion of the business combination. Completion of the business combination remains subject to timely approval by requisite governmental regulators and authorities under applicable competition laws.

10:40 EDT Pyxus up 25% after Citron Research says 'stock could double from here' - Shares of Pyxus International are rising after Citron Research sent the following tweet: $PYX would not short...speculative long. Real management and tight float. The stock could double from here as long as investors are Cannabis crazy. Our favorite hire..and it wasn't last week. linkedin.com/in/bryan-mazur/" Pyxus is up $7.22, or 25.6%, to $35.40 following the tweet. Reference Link

10:35 EDT Geolo Capital announces agreement to sell Two Roads Hospitality to Hyatt - Geolo Capital announced an agreement to sell Two Roads Hospitality to Hyatt Hotels Corporation. Under the terms of the transaction, all of Two Roads' hotel brands - Alila Hotels & Resorts, Destination Hotels, Joie de Vivre Hotels, Thompson Hotels and tommie - will join Hyatt's global portfolio. Hyatt will also assume management of Geolo's stable of iconic properties including: Carmel Valley Ranch, Ventana Big Sur, The Chicago Athletic Association Hotel, Thompson Seattle and The Beekman, A Thompson Hotel in New York. Two Roads has grown to become the leading global hospitality management company with over 85 properties across eight countries, representing $2B in total property revenues under management. While Geolo will no longer be a principal shareholder of Two Roads Hospitality, it will remain the largest owner of hotels managed by Hyatt.

10:32 EDT Industrial laser names under pressure as analysts digest IPG forecast cut - Shares of IPG Photonics (IPGP), Coherent (COHR), and nLight (LASR) are slipping after Northcoast analyst Tom Hayes downgraded all three stocks to Neutral as he sees considerable headwinds remaining in place. His peer at Stifel also lowered IPG Photonics and nLight's targets following the former's negative preliminary quarterly results announced on Friday. MOVING TO THE SIDELINES: In a research note to investors this morning, Northcoast's Hayes downgraded IPG Photonics, Coherent, and nLIGHT to Neutral from Buy as he sees considerable headwinds remaining in place, which will likely constrain unit volume growth over the next few quarters and into 2019. While the analyst pointed out that he continues to expect that industrial lasers, especially fiber lasers, will become an important tool in global manufacturing, the near-term challenges and lack of visibility are moving him to the sidelines as he expects the headwinds to extend into FY19 as trade and tariff issues weigh on demand. Hayes also noted that China is a significant market for laser demand, but its outsized component of total revenue adds some risk to operations. Based on the most recently published reports, trailing 12-month revenue in China represented 43% of IPG revenue, 9% of Coherent revenue, and 39% of nLight's revenue, he added, highlighting that his survey work as well as commentary from IPG during its second quarter earnings call point to pricing pressure in the lower range of the high-power laser market in China. Currently the majority of the pricing actions remain isolated to the China market, but Hayes believes there is an increased risk that pricing compression could expand to other geographies and further weigh on margin levels. The analyst also cited IPG Photonics' pre-announced third quarter results, which fell short of guidance as demand trends trailed off throughout the quarter. TARGET CUTS: While reiterating Buy ratings on both IPG Photonics and nLight, Sitfel analyst Patrick Ho lowered his estimates and price targets on the stocks to $190 from $228 and $32 from $40, respectively, following IPG's negative preannouncement. In addition to geopolitical concerns, Ho noted that he believes capacity digestion and a more intense competitive environment are impacting IPG's outlook near-term and his forecasts in 2019, and will also have some impact on nLight. Nonetheless, the analyst remains firm in his favorable thesis in the later as he believes nLIGHT can continue to outperform the industry, driving additional share gains in higher power laser applications and outpacing overall industrial market trends. Further, Ho sees nLight's new share wins will help offset some of the ASP pressures, but not completely given the magnitude that pricing pressures have taken hold. Meanwhile, DA Davidson analyst Thomas Diffely lowered his price target on IPG Photonics to $200 from $220 after the company lowered its third quarter revenue outlook as a result of tariff and trade related concerns in China and Europe. COHERENT, II-VI SELLOFFS SEEN AS OVERDONE: Benchmark analyst Mark Miller also lowered his estimates for IPG Photonics and cut his price target on the stock to $170 from $222 after the company lowered its third quarter revenue guidance and its expected annual sales growth, indicating that tariff and trade-related headwinds were the primary drivers behind the weaker than expected performance for its business in China and Europe. Miller believes nLIGHT will be impacted by the same market conditions IPG called out, but argued that the selling was overdone in shares of Coherent and II-VI (IIVI). Miller reiterated Buy ratings on IPG, Coherent and II-VI and a Sell rating on nLIGHT. PRICE ACTION: In morning trading, shares of IPG Photonics have dropped over 1% to $23.09, while nLight's stock has slipped almost 3% to $18.76. Also lower, shares of Coherent have slid about 2% to $154.90, while II-VI's stock is fractionally down to $39.94.

10:23 EDT Moody's confirms Disney's A2 senior unsecured long-term debt rating - Moody's Investors Service confirmed The Walt Disney Company's (DIS) A2 senior unsecured long-term debt and Prime-1 short-term ratings, thus concluding the review for downgrade initiated on June 20 after Disney raised its offer to purchase Twenty-First Century Fox's (FOXA) entertainment assets for $71.3B in stock and cash, plus the assumption of Fox debt. Moody's believes Disney will close the transaction with Fox in early 2019. Disney Enterprises Inc.'s A1 long-term debt rating was confirmed and all of the company's and its subsidiaries' shelf ratings were also confirmed as part of this rating action. The outlook is stable.

10:00 EDT Vedanta falls -7.7% - Vedanta is down -7.7%, or -95c to $11.32.

10:00 EDT Aluminum Corp. of China falls -12.8% - Aluminum Corp. of China is down -12.8%, or -$1.55 to $10.52.

10:00 EDT Gol Linhas rises 12.8% - Gol Linhas is up 12.8%, or 82c to $7.23.

09:50 EDT Gevo moves higher as Trump said to plan pro-ethanol measures - President Donald Trump is expected to announce the lifting of a federal ban on summer sales of higher-ethanol blends of gasoline on Tuesday, Reuters reported, citing two sources familiar with the matter. Shares of Gevo (GEVO) are up about 3.5% in early trading, while Green Plains (GPRE) is up about 1%. Reference Link

09:47 EDT Jeld-Wen falls -7.6% - Jeld-Wen is down -7.6%, or -$1.82 to $22.27.

09:47 EDT VelocityShares 3x Inv Natural Gas ETN falls -9.0% - VelocityShares 3x Inv Natural Gas ETN is down -9.0%, or -$1.44 to $14.60.

09:47 EDT Petrobras rises 12.1% - Petrobras is up 12.1%, or $1.69 to $15.60.

09:46 EDT Florida selects Motorola Solutions for public safety statewide radio system - The Florida Department of Management Services announced that it has the authority to award a contract to Motorola Solutions to build and manage the new statewide Project 25 public safety radio system. Motorola Solutions will provide Florida with an interoperable ASTRO 25 land mobile radio system for improved coverage, reliability and audio clarity for first responders across the state. The new Statewide Law Enforcement Radio System buildout -- valued at over half a billion dollars -- is scheduled to begin in 2020.

09:40 EDT Sonoco to implement price increase of 6%-10% for rigid plastic packaging - Sonoco announced it is implementing a price increase for all rigid plastic packaging in the United States and Canada, effective November 5, 2018. Prices will be increased between 6%-10% based on the specific resin substrate.

09:32 EDT Microsoft announces Project xCloud game-streaming project - In a blog post this morning, Microsoft announced Project xCloud, a project it says is "about providing gamers - whether they prefer console or PC - new choices in when and where they play, while giving mobile-only players access to worlds, characters and immersive stories they haven't been able to experience before." Microsoft stated in the post: "Scaling and building out Project xCloud is a multi-year journey for us. We'll begin public trials in 2019 so we can learn and scale with different volumes and locations." Reference Link

09:27 EDT VivoPower Australia sells Express Power Solar PPA projects - VivoPower announced that an affiliate of Diamond Energy has acquired the Express Power Solar PPA projects in Australia from VivoPower's wholly-owned subsidiary in Australia, VivoPower Australia. Terms were not disclosed.

09:17 EDT Fly Intel: Pre-market Movers - HIGHER: Petrobras (PBR), up 14% after the stock saw analyst upgrades following the strong showing of Jair Bolsonaro in winning the presidential election's first round in Brazil.... Tetraphase (TTPH), up 2% after announcing "positive" data from Phase 3 trials of XERAVA... Arconic (ARNC), up 3% after Reuters reported that Blackstone (BX), Carlyle Group (CG), Onex and Canada Pension Plan Investment Board have joined up in a bid to acquire the company, which is exploring its strategic options... Novamax (NVAX), up 3% after B. Riley FBR analyst George Zavoico added Novavax to his firm's Alpha Generator list based on the upcoming top-line results of two key clinical trials expected in early Q1... General Electric (GE), up 2% after Barclays analyst Julian Mitchell upgraded the stock to Overweight from Equal Weight with an unchanged price target of $16. LOWER: iRobot (IRBT), down 3% after Piper Jaffray analyst Troy Jensen downgraded the stock to Neutral with an unchanged price target of $90. The analyst continues to believe the robotic vacuum market is in a secular uptrend and that iRobot will "maintain its dominant position in the market."... Beacon Roofing (BECN), down 1% after William Blair analyst Ryan Merkel downgraded the stock to Market Perform from Outperform saying he's not confident in the near-term stock outperformance following "another soft" roofing survey... Ensco (ESV), down 2% after Ensco and Rowan Companies (RDC) agreed to merge in an all-stock transaction.

09:08 EDT Attis Industries enters agreement with NorthCrest Medical Center - Attis Industries announced that it has entered into an agreement with NorthCrest Medical Center, a community hospital located in Springfield, Tennessee. Attis Healthcare, a subsidiary of Attis Industries, will assist in the expansion and operation of their existing state-of-the-art hospital laboratory and provide outreach services within the community. Attis estimates that the laboratory will be able to test upwards of 1,000 specimens per month and the company expects to generate revenue and cash flow almost immediately from this partnership. While Attis cannot predict revenues associated with reimbursements, its diligence into the lab service market supports annual revenue in the range of $4M-$7M for rural markets, with populations, lab build out and beds similar in size to NorthCrest. Laboratory services are an integral part of healthcare and a key component in the battle against chronic disease. The ability to provide excellent service to providers can differentiate high quality laboratories from other less qualified laboratories.

09:06 EDT Comtech receives $2.3M of funding to support State of Maryland DHS - Comtech Telecommunications announced that during its first quarter of fiscal 2019, its Command and Control Technologies group, which is part of Comtech's Government Solutions segment, has been awarded additional funding for Option Year One in the amount of $2.3M on an existing contract to provide the State of Maryland Department of Human Services with statewide Technical Operations Support Service. To date, Comtech has received $6.7M of funded orders against the $11.3M contract ceiling. Comtech and its team members will work directly with the personnel of DHS to develop, maintain and support the IT needs of DHS.

09:02 EDT BorgWarner opens new plant in Wuhan, China - BorgWarner celebrated the inauguration of its new production plant in the Caidian Economic Development Zone in Wuhan, China, with a grand opening ceremony. Occupying a land area of 48,595 square meters and floor area of 26,000 square meters, the new facility integrates comprehensive functions including production, engineering, quality, sales, logistics, administration and finance. As part of its efforts to support growing demand from the Chinese combustion, hybrid and electric vehicle market, BorgWarner's new facility will produce drive motors, P2 motors, Belt Alternator Starter Systems, starters, alternators and related components.

08:49 EDT Menlo says serlopitant fails to demonstrate efficacy in Refractory Chronic Cough - Menlo Therapeutics announced top-line results from TUSSIX, its Phase 2 clinical trial of serlopitant for the treatment of refractory chronic cough. In this 185 patient study, treatment with serlopitant failed to demonstrate benefit versus placebo on the primary and key secondary endpoints. In the primary endpoint analysis of change from baseline in 24-hour cough frequency after 12 weeks of treatment, the serlopitant group had 31% less reduction than the placebo group. In a key secondary analysis of response rates, 54% of placebo treated patients and 44% of serlopitant treated patients experienced a 30% or greater reduction in 24-hour cough frequency at week 12 compared to baseline. Serlopitant was well-tolerated in this study. Treatment related adverse events occurred at comparable rates in the serlopitant and placebo treated groups. "Based upon the results of this trial, we do not anticipate further development of serlopitant for the treatment of refractory chronic cough. We sincerely thank the patients and investigators who participated in this trial. We are continuing the clinical development of serlopitant for pruritus associated with various conditions given the two successful Phase 2 clinical trials in which serlopitant demonstrated a reduction in chronic pruritus and pruritus associated with prurigo nodularis," stated Steve Basta, CEO of Menlo Therapeutics. The Phase 2 clinical trial of serlopitant to treat pruritus associated with psoriasis is fully enrolled, and data is expected in December 2018, said the company, which added that it is currently enrolling patients in two Phase 3 clinical trials - one in the U.S. and one in Europe - to evaluate serlopitant as a treatment for pruritus associated with prurigo nodularis. Data from each trial is expected in the first half of 2020.

08:42 EDT Adamas Pharmaceuticals presents final results from EASE LID 2 study of Gocovri - Adamas Pharmaceuticals announced the presentation of final results from EASE LID 2, the company's two-year Phase 3 open-label study of Gocovri extended release capsules, the first and only medicine approved by the FDA for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Overall, final results from the two-year, open-label study demonstrated that Gocovri was generally well tolerated. The data also showed the treatment effect of Gocovri on motor complications, as measured by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, or MDS-UPDRS, Part IV, was maintained for up to two years. This effect was seen in all subgroups, including those switched to Gocovri from placebo or amantadine immediate release and those with uncontrollable dyskinesia after deep brain stimulation treatment, and was achieved without compromising the underlying control of Parkinson's disease symptoms, as assessed by MDS-UPDRS, Parts I-III, which measures the non-motor and motor signs of Parkinson's disease. In the study, Gocovri provided a comparable 35% reduction in dyskinesia and OFF from baseline by week 8 that was maintained for up to 100 weeks across all subgroups naive to Gocovri, including those switched directly from amantadine IR. In addition, over 84% of Gocovri-treated patients either increased or had no change to their levodopa dosage for up to 100 weeks with 30% increasing their doses by an average of approximately 300 mgs/day. The safety data are consistent with the previously reported safety profile of Gocovri, which includes precautions and warnings related to suicidality, hallucinations, dizziness and orthostatic hypotension. Discontinuations were mostly due to reasons not related to an adverse drug reaction, or ADR. During the two-year study, 9% of patients discontinued due to adverse drug reactions compared to 33% who discontinued for reasons other than ADR. Most adverse drug reactions were of mild to moderate intensity, and the most common adverse drug reactionswere falls, hallucination, peripheral edema, constipation and urinary tract infection. Nine patients died during the course of the study because of cardiac arrest, pneumonia, sepsis, or natural causes; none were deemed study drug related.

08:36 EDT CAI International announces 3M share repurchase program - CAI International announced that its board has approved a stock repurchase program. Under the Program, CAI is authorized to repurchase up to three million shares of its outstanding common stock from time to time and at prices considered appropriate by the company depending upon share price and prevailing economic and market conditions. The Program replaces any available prior share repurchase authorization and may be discontinued at any time.

08:35 EDT Sarepta announces manufacturing partnership with Paragon Bioservices - Sarepta announced that it has entered into a long-term strategic manufacturing partnership with Paragon Bioservices, which will provide Sarepta access to additional commercial manufacturing capacity for its micro-dystrophin Duchenne muscular dystrophy, or DMD, gene therapy program, as well as a manufacturing platform for future gene therapy programs, such as Limb-girdle muscular dystrophy. Paragon employs a team of about 300 at two locations in Maryland. Paragon is constructing a new, 151,000 square-foot, GMP gene therapy biomanufacturing facility, which will be online in February 2019 and is located in Anne Arundel County.

08:34 EDT Hyatt acquires Two Roads Hospitality - Hyatt Hotels announced an agreement to acquire Two Roads Hospitality, an international lifestyle hotel management company with a unique collection of distinctive brands, properties and a robust development pipeline around the globe. The acquisition consists of a base purchase price of $480M, with the potential for Hyatt to invest up to an additional $120M in the aggregate, contingent on the outcome of certain terms to be individually defined after closing. The base plus contingent total purchase price is expected to reflect an EBITDA multiple of approximately 12-13x stabilized 2021 earnings, which Hyatt considers the best indicator of valuation based on anticipated synergies and growth. Consistent with Hyatt's long-term growth strategy to drive shareholder value, this investment in a high-growth, capital-light platform accelerates Hyatt's evolution to a more fee-driven enterprise, funded by proceeds from an asset disposition program in which real estate has been monetized at an average multiple of approximately 16.5x EBITDA to date. Notably, Hyatt is making this growth investment in a year in which it has committed to return approximately $800M of shareholder capital through a combination of share repurchases and a cash dividend.

08:33 EDT WellCare partners with agilon health - WellCare Health Plans announced it has expanded its network of providers by signing a new value-based care agreement with agilon health, a leading national organization which brings a complete operating platform for global risk to primary care physicians, to help improve access to care and drive greater health outcomes for its members in Texas.

08:32 EDT Myovant Sciences, Flo Health announce partnership - Myovant Sciences and Flo Health announced a partnership to create a digital tool to screen for heavy menstrual bleeding. Affecting more than 25% of women, heavy menstrual bleeding is associated with diseases such as uterine fibroids and can negatively impact a woman's quality of life.

08:31 EDT Pareteum announces $50M contract with One Development - Pareteum announced a $50M contract with One Development, Thailand's first mobile virtual network aggregator and enabler, and leader in the country's growing mobile virtual network operator market. Pareteum's cloud software platform will power One Development's ability to offer a turnkey solution to the over 50 companies that have obtained a mobile virtual network operator license in Thailand.

08:26 EDT Navios Acquisition to acquire publicly held units of Navios Maritime Midstream - Navios Acquisition (NNA) and Navios Maritime Midstream (NAP) announced that they have entered into a definitive merger agreement under which Navios Acquisition will acquire all of the publicly held units of Navios Midstream in exchange for shares of Navios Acquisition. Under the terms of the transaction, public unitholders of Navios Midstream may exchange each Navios Midstream common unit for either 6.292 newly issued shares of Navios Acquisition common stock; or 1 share of a newly issued series of convertible participating preferred stock of Navios Acquisition. Each share of preferred stock will be convertible by its holder into 5.1 shares of Navios Acquisition common stock at any time beginning six months after closing of the Transaction. Navios Midstream publicly held units for which no election is made will be deemed to have elected the form of consideration most elected by holders of publicly held units of Navios Midstream. In addition, if holders representing 80% or more of the publicly held units of Navios Midstream elect to receive Navios Acquisition common stock consideration, all publicly held units of Navios Midstream will be exchanged for Navios Acquisition common stock. The exchange of held units of Navios Midstream for shares of common stock or preferred stock of Navios Acquisition in the transaction is expected to be a tax-free exchange to Navios Midstream unitholders for U.S. federal income tax purposes. The conflicts committee of the board of directors of Navios Midstream negotiated the transaction on behalf of Navios Midstream and its public unitholders. The transaction was unanimously approved by the Conflicts Committee, the board of directors of Navios Midstream and the board of directors of Navios Acquisition. The approval and adoption of the merger agreement and the merger by Navios Midstream requires approval by a majority of the outstanding Navios Midstream common units. Navios Acquisition owns a sufficient number of Navios Midstream common units to approve the merger on behalf of all Navios Midstream unitholders and has agreed to consent to the merger. The closing of the merger is subject to customary closing conditions, including effectiveness of a registration statement on form F-4 related to the issuance of new shares of Navios Acquisition to the public unitholders of Navios Midstream and the mailing of an information statement to such unitholders. The transaction is expected to close around December.

08:17 EDT Cocrystal Pharma announces clinical trial agreement for CC-31244 - Cocrystal Pharma announced that it has signed a clinical trial agreement for an investigator-initiated study with the Humanity & Health Research Centre in Hong Kong. Under the clinical trial agreement, the Phase 2a study of CC-31244 for the treatment of hepatitis C will be sponsored and conducted by the Humanity & Health Research Centre, Hong Kong. As part of the agreement, Cocrystal will provide CC-31244, its lead product in development for HepC. Cocrystal's CC-31244 is an investigational, oral, potent, broad-spectrum replication inhibitor called a non-nucleoside inhibitor, or NNI. It has a high barrier to drug resistance designed and developed using the company's proprietary structure-based drug discovery technology. It is active against HCV genotypes 1-6 with no significant cytotoxicity in multiple cell types at high concentrations. The upcoming, Hong Kong Phase 2a open-label study will evaluate the safety, tolerability and preliminary efficacy of CC-31244 in combination with Sofosbuvir and Daclatasvir with or without a protease inhibitor, for the treatment of HepC. Sixteen patients will be enrolled in the Phase 2a study. This trial differs from the current Phase 2a trial Cocrystal is conducting in that testing will include for the first time a protease inhibitor. The Humanity & Health Research Centre expects to commence the study in Q4.

08:12 EDT Axalta Coating trading resumes

08:11 EDT China Lending Corp. enters agreement with Zhejiang Lixin Holding Co. - China Lending Corporation announced that it has entered into a strategic cooperation agreement with Zhejiang Lixin Holding Co., Ltd., a financial service company providing financial leasing, factoring, funding, financing guarantee and supply chain management solutions and related advisory services for individuals and MSMEs in the Yangtze River Delta Region. Pursuant to the Agreement entered into on October 8, 2018, Lixin will make full use of its related resources in helping China Lending revitalize its business through possible reorganization and restructuring as well as assisting the Company to explore potential merger and acquisition opportunities. Specifically, the partnership aims to help the Company upgrade its product portfolio to include multiple ways of micro financing currently in market demand, increase its market shares in the segmented niches of supply-chain financing, and expand its business to eastern regions of China. In return, Lixin hopes to access China's western regional markets, where Lixin's expertise in financial solutions should resonate favourably with a large body of potential customers. The partnership, in short, complement resources and advantages to generate sustainable growth for both parties.

08:10 EDT L3 Technologies awarded IDIQ contract from U.S. Army for ISR sensors - L3 Technologies announced that it has been awarded an indefinite-delivery/indefinite-quantity contract valued at up to $454M from the U.S. Army for the next-generation WESCAM MX-10D electro-optical/infrared and laser designator sensor suite. These modernized ISR systems operate from the Army's Tactical Unmanned Air Systems Shadow UAV and provide an advanced capability to collect critical information for use by all members of an air-ground maneuver team. This is a five-year contract, with an option for the U.S. Army to extend for an additional five years. L3 will continue to invest in research and development as the U.S. Army will be evaluating options for its next-generation Future Tactical Unmanned Aircraft System program, the replacement for Shadow, targeted for 2025.

08:09 EDT Apollo Global to acquire about $1B portfolio of investments from GE Capital

08:09 EDT Takeda Pharmaceutical presents long-term efficacy analyses for Entyvio - Takeda Pharmaceuticals announced the presentation of new long-term efficacy real-world data analyses for Entyvio at ACG 2018 in Philadelphia, PA. Studies of note include a retrospective multicentre cohort study of biologic-naive adults with ulcerative colitis and Crohn's disease, two systematic reviews and meta-analyses of real-world treatment persistence and mucosal healing, and a time-trend analysis of Entyvio utilization and outcomes across the United States. A total of 10 Entyvio abstracts were accepted for presentation at the meeting. The retrospective cohort study included 249 patients (UC: 166; CD: 83) with no prior exposure to biologic drugs for the treatment of UC or CD who initiated Entyvio treatment. Cumulative probability of clinical outcomes and treatment persistence were analyzed by Kaplan Meier method. At 18 months, 78.6% of UC and 74.8% of CD patients persisted on Entyvio treatment, and at 24 months, 76.9% of UC and 74.8% of CD patients persisted. High rates of treatment persistence (greater than or equal to 75%), clinical response, clinical remission and mucosal healing are observed in bio-naive Entyvio patients after 18 months. The abstract featuring a systematic review of treatment persistence showed similar trends in persistence rates. This meta-analysis identified 16 studies that reported Entyvio persistence or discontinuation rates in UC and CD patients. At 12 months, approximately three-quarters and nearly two-thirds of UC and CD patients, respectively, persisted with Entyvio treatment despite utilization in largely biologic-refractory patients. Higher Entyvio persistence was seen in bio-naive patients. These results will need to be confirmed with a larger cohort.

08:06 EDT Motorola Solutions announces Si500 body-worn cameras used by Orlando PD - Police officers from the Orlando Police Department are using Motorola Solutions Si500 body-worn cameras to strengthen community trust by improving accountability and transparency. When a video is taken, built-in security protects evidence captured at the scene of incident so that it remains untouched throughout its lifecycle. Cybersecurity is critical in this day and age, especially when it comes to information that can help protect communities. The Si500 and its digital evidence management software is a secure solution that safeguards evidence against tampering. Chain of custody is automatically established when a video and additional information is captured. The Si500 goes beyond industry practices for cybersecurity protocols and data integrity. Videos are encrypted both on the Si500 and when being transmitted over Wi-Fi. The Si500 is also more than a body-worn camera. It includes a touch screen for evidence management and has a built-in speaker microphone that connects to Motorola Solutions APX two-way radios. Officers do not need to wear a separate speaker microphone, reducing the load they have to carry when on patrol. The Si500 works seamlessly with Motorola Solutions' end-to-end suite of command center software designed to improve operations from the time an emergency call is placed to after an incident is resolved.

08:06 EDT Kratos Defense receives task order from KBR Wyle for additional training - Kratos Defense announced that it was awarded a task order, or TO, from KBR Wyle for an additional year of UH-1N aerial gunnery simulation training for the U.S. Air Force at the Kratos Aircrew Training Center, or KATC. Kratos has been conducting training for Air Force Global Strike Command, or AFGSC, special mission aviators since 2017. Kratos' aircrew training center's full-mission simulators provide a cost-effective solution by minimizing lifecycle expenses associated with simulator ownership while maintaining training quality. AFGSC aircrew members are led by experienced Kratos instructors and train using the latest technologies and simulation systems to ensure mission readiness. In addition to aerial gunnery training the KATC provides advanced rotary-wing and search and rescue training. The original IDIQ contract was awarded last year by KBR Wyle. This is the second TO issued under that contract. Due to customer related, competitive and other considerations, no additional information is being provided relative to this competitive contract award.

08:04 EDT Exelixis initiates Phase 3 pivotal trial of cabozantinib - Exelixis announced the initiation of a phase 3 pivotal trial of single-agent cabozantinib in patients with radioiodine-refractory differentiated thyroid cancer who have progressed after up to two prior vascular endothelial growth factor receptor, or VEGFR,-targeted therapies. The co-primary endpoints for the trial are progression-free survival and objective response rate. COSMIC-311 is a multicenter, randomized, double-blind, placebo-controlled phase 3 pivotal trial that aims to enroll approximately 300 patients at approximately 150 sites globally. Patients will be randomized in a 2:1 ratio to receive either cabozantinib 60 mg or placebo once daily.

08:02 EDT Axalta Coating names Robert Bryant interim CEO, effective immediately - Axalta Coating announced that its Board of Directors has appointed Robert Bryant, Axalta's Executive Vice President and CFO, to the additional role of interim CEO, effective immediately. Bryant succeeds Terrence Hahn, who has resigned by mutual agreement with the Board, following an investigation by outside counsel into conduct by Hahn unrelated to financial matters that Axalta believes was inconsistent with Company policies. Hahn has also vacated his position on the Board. Axalta also announced that its preliminary results for the third quarter are in line with the company's guidance communicated during its second quarter earnings update, which specified third quarter adjusted EBITDA of approximately 24% of the midpoint of its full-year range.

07:40 EDT Axalta Coating trading halted, news pending

07:38 EDT Spark Therapeutics announces preclinical data for SPK-3006 for Pompe disease - Spark Therapeutics announced new data for SPK-3006, an investigational liver-directed adeno-associated viral, or AAV, gene therapy for Pompe disease. The data from the investigational new drug, or IND-enabling studies, were presented during the late breaking session at the International Congress of the World Muscle Society. Preclinical studies in a Pompe disease model demonstrated a greater therapeutic response and a lower immunogenicity profile of secretable gene encoding acid alpha-glucosidase, or GAA, expressed by this transgene in liver cells following AAV gene transfer compared to both native GAA expressed by the liver as well as native GAA expressed directly in muscle tissue. Preclinical studies evaluating activity of the secretable, modified GAA enzyme found in SPK-3006 in acid alpha-glucosidase knockout mice showed decreased glycogen accumulation, increased survival and improved cardiac, respiratory and muscle function. In these studies, animals were followed up for up to 10 months after gene transfer and no vector-related toxicities were observed. Importantly, the induced liver expression of secretable GAA demonstrated greater ability in restoring muscle strength compared to the standard of care regimen of 20 mg/kg bi-weekly enzyme replacement therapy, or ERT. Secretable GAA was significantly better than ERT in breaking down glycogen in refractory muscle groups, including quadriceps and triceps. Additionally, a single infusion of SPK-3006 at three ascending doses in a non-human primate study conducted by Spark Therapeutics demonstrated dose-dependent expression of GAA in plasma. Long-term follow up of NHPs following infusion of SPK-3006 is ongoing, with a six-month follow up to date and no observed vector-related toxicities.

07:33 EDT Theravance Biopharma reports 'positive' data from multiple studies of VIBATIV - Theravance Biopharma announced that positive new data from multiple studies of VIBATIV were presented at IDWeek 2018, which was held in San Francisco, CA, on October 3 - 7, 2018. Two presentations were made reporting new data from the ongoing Telavancin Observational Use Registry study, which is designed to report how VIBATIV is being used by healthcare practitioners to treat patients in real-world clinical settings. Presented findings from one study reported a positive clinical response following VIBATIV treatment in 77.1% of registry patients diagnosed with monomicrobial infections caused by Staphylococcus aureus with vancomycin minimum inhibitory concentration greater than or equal to 1 microg/mL. Positive clinical response was defined as cure or improvement leading to step-down oral therapy. Results from a second study demonstrated that renal function was unchanged in 68.7% of TOUR patients who received treatment with VIBATIV for more than 21 days and had creatinine clearance measured at baseline and end of treatment. Researchers presented data reported for 159 patients captured in the TOUR study who were diagnosed with monomicrobial S. aureus infections with vancomycin MIC greater than or equal to 1 microg/mL . Of these VIBATIV was used as a second-line or greater therapy in 77.4% of patients, with 44.0% having previously been treated with vancomycin. Among the 144 patients who had an outcome assessment at end of therapy with VIBATIV, a positive clinical response was reported for 77.1%, with 9.7% failing to respond to treatment and 13.2% having an indeterminate clinical outcome. The patients' most common infection types were complicated skin and skin structure infections (45.9%), bacteremia and endocarditis (20.1%), and osteomyelitis (15.7%). The median VIBATIV daily dose and duration of treatment were 8.5 mg/kg and 8 days, respectively. Of the 159 patients, 17 reported an adverse event, with 12 discontinuing treatment due to an adverse event. The most commonly occurring adverse event was renal failure (4.4%), which resolved in the majority of cases. Importantly, there were no new safety signals identified in this patient subset.

07:17 EDT Amicus to collaborate with Penn to develop AAV gene therapies - Amicus announced a major collaboration with the gene therapy program in the Perelman School of Medicine at the University of Pennsylvania, or Penn, to pursue research and development of novel gene therapies for Pompe disease, Fabry disease, CDKL5 deficiency and one additional undisclosed rare metabolic disorder. This relationship will combine Amicus' protein engineering and glycobiology expertise with Penn's adeno associated virus, or AAV, gene transfer technologies to develop AAV gene therapies designed for optimal cellular uptake, targeting, dosing, safety and manufacturability. Penn's AAV vector technology is designed to improve targeting, tropism, safety, immunogenicity, and gene delivery, while Amicus' protein engineering capabilities may optimize protein expression, secretion, targeting and uptake of the target protein. The agreement between Amicus and Penn is a research, collaboration and license agreement, with funding provided to Penn to advance the preclinical research programs in the Wilson Lab and to license certain technologies invented under the funded research collaboration. The collaboration program will focus on developing innovative new AAV gene therapies for Pompe disease, Fabry disease, CDKL5 deficiency and one additional undisclosed rare metabolic disorder.

07:11 EDT BioXcel Therapeutics submits IND application for BXCL701 - BioXcel Therapeutics announced it has submitted an investigational new drug, or IND, application to the FDA to evaluate its lead immuno-oncology candidate, BXCL701, in combination with pembrolizumab as a potential therapy for treatment emergent neuroendocrine prostate cancer, or tNEPC. BTI expects to initiate the trial, subject to IND approval, in Q4. BXCL701 is an oral immunotherapy with dual mechanisms of action that has demonstrated single agent activity in melanoma, with an established safety profile from 700 healthy subjects and cancer patients. Designed to stimulate both the innate and acquired immune systems, BXCL701 works by inhibiting dipeptidyl peptidase and blocking immune evasion by targeting fibroblast activation protein. Preclinical combination data evaluating BXCL701, a checkpoint inhibitor and other immuno-oncology agents has demonstrated encouraging anti-tumor activity in multiple tumor types and formation of functional immunological memory. BXCL701's primary mechanism of action has recently been highlighted in multiple peer reviewed journals, providing further validation of the scientific rationale behind BXCL701.

07:08 EDT Inspire Medical announces first implant of sensing lead in Europe - Inspire Medical announced the first implant of its new sensing lead in Europe. The implant was successfully completed by Joachim Maurer, University Hospital, Mannheim, Germany, who has now overseen 80 Inspire therapy cases. Maurer is an ear nose and throat, or ENT, surgeon and head of the sleep disorders center. The sensing lead monitors a patient's respiratory pattern as the implanted Inspire system delivers stimulation to the upper airway in order to prevent obstructions during sleep. The new 4340 sensing lead has a smaller profile, including a reduction in diameter of 49%, as compared to the prior design. This diminished profile improves patient comfort. The new design also incorporates several features to enhance the ease of implant and reduce surgical time for an ENT surgeon. Inspire intends to introduce the new sensing lead to other centers in Europe in the near future. Currently, the 4340 sensing lead is under review by the FDA and, pending clearance, the company expects the product to be available in the U.S. in early 2019.

07:05 EDT Viking Therapeutics presents 'positive' data from in vivo study of VK2809 - Viking Therapeutics announced the presentation of positive data from a study of VK2809 in an in vivo model of glycogen storage disease type Ia at the 88th Annual Meeting of the American Thyroid Association in Washington, D.C. The results demonstrated that treatment with VK2809 led to an overall improvement in liver health highlighted by restoration of autophagy, reduction in steatosis, and improvements in inflammation and liver size. The study investigators concluded that these histological improvements are potentially relevant to non-alcoholic fatty liver disease, including non-alcoholic steatohepatitis, due to certain similarities between those conditions and GSD Ia. The results demonstrated decreases in steatosis, liver mass, and triglyceride concentration in VK2809-treated cohorts compared with vehicle controls. Significant improvements in LC3B-II protein density, an important mediator of fat disposal, as well as reduced levels of p62 protein, were also observed. These data suggest that, in addition to stimulation of beta-oxidation via increased PGC1-alpha and CPT1-alpha expression, restoration of autophagy may be contributing to the reduction of fat content in this setting. Importantly, this study also demonstrated indications of reduced inflammatory signalling following treatment with VK2809. The expression of inflammatory markers such as tumor necrosis factor alpha and interleukin 6 were normalized or reduced in the livers of VK2809-treated cohorts compared with vehicle controls, suggesting an overall reduction in inflammation. These data may be of interest for other indications in which inflammation plays a role in disease progression and severity.

07:05 EDT Recro Pharma announces PDUFA goal date for NDA for meloxicam - Recro Pharma announced that the FDA has set a PDUFA goal date of March 24, 2019 for its decision on the new drug application, or NDA for intravenous meloxicam for the management of moderate to severe pain. Recro resubmitted the NDA for IV meloxicam in September in reply to a complete response letter, or CRL, received from the FDA in May. The FDA's stated reason for the CRL was that data from ad hoc analyses and selective secondary endpoints suggested that the analgesic effect of IV meloxicam does not meet the expectations of the FDA. The CRL also raised CMC-related questions on extractable and leachable data provided in the NDA. Recro believes the resubmitted NDA addresses the FDA's concerns surrounding these items.

07:02 EDT Bausch Health's BRYHALI Lotion, 0.01% receives tentative FDA approval - Bausch Health Companies and its dermatology business, Ortho Dermatologics, announced that the U.S. FDA has provided tentative approval of the New Drug Application for BRYHALI Lotion, 0.01%, for the topical treatment of plaque psoriasis in adult patients. BRYHALI Lotion is a new potent to superpotent corticosteroid that contains 0.01 percent halobetasol propionate in a novel vehicle lotion. Its safety has been established in clinical trials with dosing for up to eight weeks with no increase in epidermal atrophy. The final FDA approval for BRYHALI Lotion is pending the expiration of exclusivity for a related product, which is expected in early November 2018. The company plans to launch BRYHALI Lotion shortly thereafter, as scheduled, in November 2018.

06:58 EDT Brown & Brown announces asset acquisition of FNI Management Group - J. Scott Penny, Chief Acquisitions Officer of Brown & Brown, and Howard Brinn and Mike Mitchell, the principals of FNI Management Group, announced that Brown & Brown of Kentucky, a subsidiary of Brown & Brown, has acquired substantially all of the assets of FNI. FNI has annual revenues of approximately $1.5M. Howard and Mike will become part of the Brown & Brown auto, RV and powersports practice, working with the Automotive Development Group team. The entire practice operates under the leadership of Mike Neal, President of Brown & Brown of Kentucky.

06:54 EDT Thomson Reuters announces $4.45 distribution, purchases 138M shares - Thomson Reuters has taken up and purchased for cancellation approximately 138M common shares at a purchase price of $47.00 per share, for a total cost of approximately $6.5B. The shares purchased represented 19.7% of the shares issued and outstanding on a non-diluted basis at the time that the substantial issuer bid/tender offer, or SIB was announced in late August. After giving effect to the SIB, approximately 563M shares will be issued and outstanding. The company's principal shareholder, The Woodbridge Company and its affiliates made a proportionate tender, which maintained its proportionate equity ownership in Thomson Reuters at approximately 64% upon completion of the SIB. Payment and settlement for the purchased shares will be effected by Computershare Trust of Canada in accordance with settlement procedures described in the SIB and applicable law. The full details of the SIB are described in the offer to purchase and issuer bid circular dated as of August 28, letter of transmittal, notice of guaranteed delivery and other related documents. Thomson Reuters also announced that a special meeting of shareholders will be held on November 19 where shareholders will be asked to approve the distribution of $4.45 in cash per common share, or approximately $2.5B in the aggregate, to holders of common shares and a consolidation of outstanding common shares on a basis that is proportional to the cash distribution. To that end, the share consolidation ratio will be based on the volume weighed average trading price of the common shares on the New York Stock Exchange for the five trading days immediately prior to the return of capital becoming effective. The proposed transaction is intended to distribute cash on a basis that is generally expected to be tax-free for Canadian tax purposes. Taxable non-Canadian resident shareholders will be able to opt out of the transaction. This right to opt out is being provided to those shareholders because in jurisdictions other than Canada the tax consequences of not participating in the transaction may be preferable to those associated with participating in the transaction. A taxable non-Canadian resident shareholder that chooses to opt out will not receive the cash distribution and will continue to hold the same number of Thomson Reuters shares that they currently hold. The proposed transaction requires approval by at least two-thirds of the votes cast at the special meeting. The board of directors of the company is unanimously recommending that shareholders vote in favor. Woodbridge has indicated that it plans to do so and, accordingly, it is expected that the shareholder vote will pass. The transaction also requires the approval of the Ontario Superior Court of Justice. If shareholder and court approval are obtained, Thomson Reuters expects to effect the proposed transaction by the end of November.

06:51 EDT Ensco to merge with Rowan Companies in all-stock transaction

06:50 EDT Iron Mountain acquires GRM China - Iron Mountain announced the acquisition of GRM's Chinese operations, significantly expanding the company's presence and market leading position in the country. The acquisition of GRM China will expand Iron Mountain's presence in Beijing, Shanghai, Guangdong, Qingdao, Dalian, Chengdu and Wuhan; 550 customers; and add 170 employees to its Chinese operations.

06:39 EDT Thomson Reuters announces steps to complete $10B return to shareholders - Thomson Reuters finalized its planned uses of proceeds from the recently completed sale of a 55% interest in its financial & risk, or F&R, business. The company is in the process of returning $10B of the F&R transaction proceeds to its shareholders. Approximately $6.5B is being returned in connection with the settlement of its substantial issuer bid/tender offer, or SIB, on or around October 9. Approximately $2.5B will be returned to its shareholders through a return of capital transaction consisting of a cash distribution of $4.45 per common share and a share consolidation, or reverse stock split, which will reduce the number of outstanding common shares on a basis that is proportional to the cash distribution. Approximately $1B will be returned to shareholders through share repurchases under its normal course issuer bid. Approximately $556M of this amount has been repurchased this year and an additional $444M of shares is expected to be repurchased later this year and in 2019. Approximately $4B of debt has been repaid since closing the F&R transaction. The company plans to maintain approximately $2B of cash on its balance sheet to fund focused acquisitions and utilize approximately $1B to cover F&R transaction-related expenses, including cash taxes, pension contributions, bond redemption costs, one-time costs and other fees and outflows related to the transaction.

06:33 EDT Tetraphase announces 'positive' data from Phase 3 trials of XERAVA - Tetraphase Pharmaceuticals announced data from a pooled analysis of two Phase 3 studies of XERAVA in complicated intra-abdominal infection and a Phase 1 multiple-ascending dose study for its pipeline candidate TP-6076. These data were presented at the Infectious Disease Society of America's Infectious Disease Week 2018, held October 3-7 in San Francisco. "The data presented at IDWeek demonstrate high clinical cure rates and microbiological eradication with XERAVA among patients with cIAI and concurrent bacteremia," said Guy Macdonald, President and CEO of Tetraphase. "These data confirm the efficacy of XERAVA in a subgroup of cIAI patients who may be at higher risk for poor outcomes, and this new analysis comes at an exciting time as we make final preparations for the commercial launch of XERAVA in the coming weeks." Macdonald added, "We are also encouraged by the positive safety, tolerability and pharmacokinetic data from the multiple-ascending dose Phase 1 study evaluating a seven-day dosing regimen for intravenous TP-6076. We plan to advance TP-6076 to a bronchopulmonary disposition study beginning in the first quarter of 2019 to confirm appropriate therapeutic levels of TP-6076 in the lungs to treat infections caused by Acinetobacter baumannii and other MDR pathogens. In previously completed in vitro testing, TP-6076 MIC90 values were as much as 64-fold lower than those for tigecycline against MDR Gram-negative pathogens, including Acinetobacter baumannii, suggesting that TP-6076 could be a potent treatment for these difficult-to-treat bacteria. We are enthusiastic about the potential for TP-6076 and the future of this program."

06:31 EDT Forum Energy acquires Houston Global Heat Transfer, terms not disclosed - Forum Energy announced that it acquired the stock of Houston Global Heat Transfer from Pelican Energy Partners, a Houston-based oilfield services focused private equity fund, and GHT management. Based in Houston, Texas, GHT designs, engineers, and manufactures premium industrial heat exchanger and cooling systems used primarily on hydraulic fracturing equipment. GHT's flagship product, the Jumbotron, is an innovative cube-style radiator that substantially reduces customer maintenance expense.

06:06 EDT Target introduces lower-priced brand Smartly - Target announced the introduction of Smartly, a new lower-priced owned brand comprised of more than 70 items, such as hand soap, paper plates, household cleaners and razors, with most items less than $2.00. The collection will arrive in stores and on Target.com beginning October 14 and will be available year-round. Prices range from 59c to $11.99, with most under $2.00. In addition to incredible value, Target's product design and development team doubled down on design and key attributes, such as a variety of fragrances developed in partnership with master perfumers. Products will be sold individually or in small multi-packs.

06:04 EDT DaVita inpatient hospital services reaccredited by joint commision - DaVita Kidney Care, a division of DaVita, announced DaVita Hospital Services has received its second reaccreditation for Ambulatory Health Care from The Joint Commission. The reaccreditation, effective 2018, is a symbol of quality earned by DaVita Hospital Services for meeting or exceeding performance standards set by The Joint Commission. Reaccreditation focuses on enhancing the quality and safety of patient care through improved clinical outcomes and performance metrics, risk management and survey preparedness.

06:02 EDT JAKKS Pacific signs deal with Paramount Players for Creepy Crawlers film - JAKKS Pacific (JAKK) announced Paramount Players, a division of Viacom's (VIAB, VIA) Paramount Pictures, has officially acquired the feature film rights to Creepy Crawlers, the iconic toy brand owned by JAKKS Pacific. Neal H. Moritz will produce and Marc Gurvitz and Stephen Berman will serve as executive producers of the feature film. Ali Bell and Royce Reeves-Darby will be overseeing the project for Paramount Players.

05:19 EDT Northern Trust hires chief investment strategist for EMEA, APAC - Northern Trust Asset Management has hired Wouter Sturkenboom as chief investment strategist for its Europe, Middle East, Africa, or EMEA, and Asia-Pacific, or APAC, regions. In this newly created role, Sturkenboom will be responsible for designing, implementing and communicating global investment strategy to the firm's growing investor base. Sturkenboom most recently spent six years at Russell Investments as a senior investment strategist first based in London and then in New York.

05:15 EDT Akers Biosciences announces settlement of Pulse Health lawsuit - Akers Bio announces that it has reached a settlement agreement with Pulse Health which had filed a lawsuit against the company on September 30, 2016 in United States Federal District Court, District of Oregon, alleging a breach of contract under the settlement agreement entered into by the company and Pulse Health on April 8, 2011. Pursuant to the settlement reached between Pulse Health and Akers Bio, the company will pay $930,000 to Pulse Health. Akers Bio has also agreed to a permanent injunction and will not make, use, sell or offer to sell the BreathScan OxiChek product, any product that detects aldehydes or oxidative stress in exhaled human breath or breath condensate using either basic fuchsin or sodium metabisulfite or any form, analog or equivalent thereof, and the BreathScan Lync device, or any equivalent thereof, as part of a test for aldehydes or oxidative stress in human exhaled breath or breath condensate. The United States District Court for the District of Oregon filed the injunction on October 3, 2018, and the injunction was entered on the docket on October 4, 2018. The company does not anticipate a material impact on revenues as a result of the withdrawal of the BreathScan OxiChek product from sale.

05:10 EDT Novartis announces FDA, EMA filing acceptance of siponimod - Novartis announced that both the FDA and European Medicines Agency have accepted the company's New Drug Application, or NDA, and Marketing Authorization Application, or MAA, respectively, for investigational oral, once-daily siponimod for the treatment of secondary progressive multiple sclerosis in adults. This phase of multiple sclerosis, or MS, can substantially impact lives, due to physical and cognitive impairments. To bring this treatment to the MS community as quickly as possible, Novartis used a review voucher to expedite the review of siponimod in the U.S. Regulatory action for siponimod is anticipated in the U.S. in March of 2019 and in Europe in late 2019.