Stockwinners Market Radar for June 04, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:18 EDT Washington AG files campaign finance suits against Facebook, Google - Washington state Attorney General Bob Ferguson filed campaign finance lawsuits in King County Superior Court today alleging Facebook (FB) and Google (GOOG) failed to maintain legally required information for Washington state political advertising placed on their online platforms since 2013. Washington state campaign finance laws require commercial advertisers that sell political advertising to maintain information about those who purchase advertising. The advertisers are also required to make that information available to the public. According to documents filed with the state Public Disclosure Commission, in the last decade, Washington candidates and political committees reported about $3.4M in payments to Facebook and $1.5M to Google related to advertising. "Washington's political advertising disclosure laws apply to everyone, whether you are a small-town newspaper or a large corporation," Ferguson said. "Washingtonians have a right to know who's paying for the political advertising they see." The state seeks penalties and injunctive relief. The defendants will have 20 days from the date they are served to respond to the state's complaint. Reference Link

18:06 EDT S&P announces changes to S&P 100, 500, 600 indices - S&P Dow Jones Indices will make the following changes to the S&P 100, S&P 500 and S&P SmallCap 600 effective prior to the open of trading on Thursday, June 7: Netflix (NFLX) will replace Monsanto (MON) in the S&P 100, and Twitter (TWTR) will replace Monsanto in the S&P 500. Bayer (BAYRY) is acquiring Monsanto in a deal expected to be completed soon pending final conditions. REGENXBIO (RGNX) will replace General Cable (BGC) in the S&P SmallCap 600. Prysmian Group is acquiring General Cable in a deal expected to be completed soon pending final conditions.

18:01 EDT Tesaro says Zejula data 'promising' - Tesaro summarized the results of the TOPACIO and QUADRA trials during an investor briefing held in conjunction with the 2018 American Society of Clinical Oncology Annual Meeting. "The promising data presented at this year's ASCO meeting demonstrated the potential of ZEJULA not only as a monotherapy treatment for women with advanced ovarian cancer, but also in combination with an anti-PD-1 antibody, to provide a meaningful clinical benefit to patients beyond those with BRCA mutations," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "Our oncology development strategy is focused on rational therapeutic combinations and niraparib and TSR-042, our anti-PD-1 antibody, are the foundation of this strategy. The TOPACIO results support the advancement of combination studies in ovarian cancer and breast cancers and we have initiated preparations for registrational trials of niraparib in combination with TSR-042 in these settings. QUADRA results demonstrated that ZEJULA is active as a late-line treatment for patients beyond those with BRCA mutations, which is the only treatment setting in which PARP inhibitors are approved today, and we intend to submit an sNDA in the fourth quarter of 2018."

17:34 EDT Banco Popular to acquire Wells Fargo's auto finance business in Puerto Rico - Management said, "On February 14, 2018, we announced that Banco Popular de Puerto Rico, our Puerto Rico banking subsidiary, agreed to acquire certain assets and liabilities related to Wells Fargo's auto finance business in Puerto Rico. On May 31, 2018 we filed a notice with the Board of Governors of the Federal Reserve System in order for Popular Auto, LLC, BPPR's direct, wholly-owned subsidiary, to be permitted to consummate the transaction. Although there can be no guarantee that regulatory approval will be received, we now anticipate that the transaction will close during the third quarter of 2018."

17:27 EDT Amgen falls after Neulasta biosimilar approved by FDA, Mylan spikes higher - The U.S. Food and Drug Administration approved Fulphilaas, the first biosimilar to Amgen's (AMGN) Neulasta, to decrease the chance of infection as suggested by febrile neutropenia, in patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.The FDA granted approval of Fulphila to Mylan GmbH (MYL). Shares of Amgen are down almost 2% after the news of the FDA approving Fulphilaas, while shares of Mylan are up 5.4% in after-hours trading.

17:25 EDT Twitter up 4% following inclusion in S&P 500 on June 7 - In after-hours trading, shares are up 4% to $39.43.

17:22 EDT Regenxbio to replace General Cable in S&P 600 at open on June 7 - Prysmian Group is acquiring General Cable in a deal expected to be completed soon pending final conditions.

17:21 EDT Intracoastal Capital reprots 9.99% passive stake in Stellar Biotechnologies

17:15 EDT FDA approves first biosimilar to Neulasta - The U.S. Food and Drug Administration today approved Fulphila, pegfilgrastim-jmdb, as the first biosimilar to Neulasta to decrease the chance of infection as suggested by febrile neutropeniafever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells, in patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.The FDA granted approval of Fulphila to Mylan GmbH (MYL). Neulasta is made by Amgen (AMGN).

17:14 EDT Biotechnology Value Fund reports 9.99% passive stake in Cidara Therapeutics

17:07 EDT MarketAxess reports May trading volume - MarketAxess announced total monthly trading volume for May of $141.2B, consisting of $75.1B in U.S. high-grade volume, $61.8B in other credit volume, and $4.4B in liquid products volume.

17:03 EDT Lynparza, Abiraterone combo delayed disease progression in Phase 2 trial - AstraZeneca (AZN) and Merck (MRK) presented data which showed clinical improvement in median radiologic progression-free survival with LYNPARZA in combination with abiraterone compared to abiraterone monotherapy, a current standard of care, in metastatic castration-resistant prostate cancer. LYNPARZA is being jointly developed and commercialized by AstraZeneca and Merck. The results of Study 08, a randomized, double-blinded, multi-center Phase 2 trial, comparing LYNPARZA in combination with abiraterone to abiraterone monotherapy in patients with previously-treated mCRPC, regardless of homologous recombination repair mutation status, were presented at the 2018 American Society of Clinical Oncology Annual Meeting as a "Best of ASCO presentation" and were published online today in The Lancet Oncology. The primary endpoint was rPFS. Secondary endpoints included time to second progression or death, overall survival and health-related quality of life. Median rPFS was 13.8 months with LYNPARZA and abiraterone compared to 8.2 months with abiraterone alone. Median PFS2 was 23.3 months versus 18.5 months. Median OS was 22.7 months with combination treatment versus 20.9 months with abiraterone alone. Pre-specified exploratory subgroup analyses demonstrated an rPFS improvement in patients regardless of HRR status. Study 08 was not powered for subgroup analyses, PFS2 and OS. HRR mutation status was not known for all patients. Noel Clarke, professor of urological oncology, Christie NHS Foundation Trust, Manchester, United Kingdom, said, "This is the first time we have seen an improvement with the use of a PARP inhibitor in combination with abiraterone in patients with metastatic castration-resistant prostate cancer, and this effect may be independent of HRR status. The data suggest this therapeutic combination may be a promising new treatment approach for this aggressive disease." Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said, "A previous trial demonstrated improvements in response rates with LYNPARZA monotherapy in metastatic castration-resistant patients with HRR mutations. The Study 08 combination data suggest that, regardless of their mutation status, men with metastatic castration-resistant prostate cancer may potentially benefit from LYNPARZA in combination with abiraterone."

16:54 EDT Mylan, Biocon announce FDA approval of Mylan's Fulphila - Mylan and Biocon announced that the FDA has approved Mylan's Fulphila, a biosimilar to Neulasta, co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia in patients treated with chemotherapy in certain types of cancer. Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon's joint portfolio approved in the U.S. Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be available at launch to further support patients and caregivers with treatment.

16:46 EDT Chemours announces price increase for Methylamines products in North America - The Chemours Company announced a 10% price increase for all Methylamines, Dimethylformamide, Dimethylacetamide and Dimethyl Sulfate products sold in North America. The price increase is effective July 1, 2018 or as contracts allow.

16:38 EDT Ranger Energy Services CFO Shaw resigns, Blossman named next CFO - Ranger Energy Services announced that Robert S. Shaw Jr., the company's CFO, has resigned effective immediately to pursue other opportunities. There were no disagreements involving the company's financial statements, internal controls or financial reporting procedures that led to Shaw's departure. Brandon Blossman, currently the company's Vice President of Mergers & Acquisitions, Financial Planning and Analysis, will assume the role of CFO. Blossman joined the xompany earlier this year as part of the financial leadership team.

16:33 EDT Amedisys to repurchase 50% of shares held by KKR - Amedisy (AMED) announced it has purchased 2,418,304 of its common shares from KKR (KKR), representing one-half of their holdings in the company and 7.1% of the aggregate outstanding shares of the Company's common stock. The Company repurchased the shares at 96% of the closing price of the Company's common stock on June 4, 2018. KKR will maintain its presence on the Amedisys Board of Directors for at least twelve months following the transaction. The aggregate value of the transaction is approximately $178M and will be financed through the use of $140M of available cash with the remainder funded by borrowings under the Company's existing revolving credit facility. For Amedisys, this transaction will be immediately 6% to 7% accretive to earnings per common share. Post transaction, the Company's available cash will be approximately $20M and its outstanding borrowings under the credit facility will be $128M resulting in a net leverage ratio of approximately 0.7x. The company is also in advanced discussions with its lenders to significantly expand its borrowing capacity under its senior secured credit facility to allow it to capitalize on its active acquisition pipeline. Following this transaction, Amedisys will have approximately 32M of outstanding shares of common stock.

16:32 EDT Opaleye Management reports 7.81% passive stake in Cidara Therapeutics

16:31 EDT Starbucks' Schultz: Company at its best when stores are 'welcoming places' - Starbucks executive chairman Howard Schultz wrote a letter to Starbucks partners, confirming that, on June 26, he will officially leave Starbucks and become chairman emeritus. "Please remember, Starbucks is at its best when our stores and offices are welcoming places for everyone," Schultz said in the letter. "So stay true to our reason for being: inspiring and nurturing the human spirit through a sense of community and human connection. As you adhere to our core purpose, do not forget to innovate around it. Never embrace the status quo. Instead, have the curiosity to look around corners and the courage to push for reinvention. Change is inevitable, and the world has become a more fragile place since we first opened our doors. Amid the chaos, try to listen with empathy, respond with kindness, and do your best to perform through the lens of humanity. Do not be a bystander. Instead, choose to be responsible for what you see and hear. No person or company is ever perfect, so learn from mistakes and be forgiving of yourself and others. And when goals are achieved, remember: success is always best when shared. And yet... success is not an entitlement; it must be earned every day through hard work and teamwork. If you strive to be the best version of yourself and bring out the best in others, your dreams will come true again and again, and Starbucks mission, values, and guiding principles will endure." Schultz added that CEO Kevin Johnson is a "true servant leader" who will lead the company as it "enters its next journey."

16:28 EDT Starbucks' Schultz: Company at its best when stores are 'welcoming places' - Starbucks founder Howard Schultz wrote a letter to Starbucks partners, confirming that, on June 26, he will officially leave Starbucks and become chairman emeritus. "Please remember, Starbucks is at its best when our stores and offices are welcoming places for everyone," Schultz said in the letter. "So stay true to our reason for being: inspiring and nurturing the human spirit through a sense of community and human connection. As you adhere to our core purpose, do not forget to innovate around it. Never embrace the status quo. Instead, have the curiosity to look around corners and the courage to push for reinvention. Change is inevitable, and the world has become a more fragile place since we first opened our doors. Amid the chaos, try to listen with empathy, respond with kindness, and do your best to perform through the lens of humanity. Do not be a bystander. Instead, choose to be responsible for what you see and hear. No person or company is ever perfect, so learn from mistakes and be forgiving of yourself and others. And when goals are achieved, remember: success is always best when shared. And yet... success is not an entitlement; it must be earned every day through hard work and teamwork. If you strive to be the best version of yourself and bring out the best in others, your dreams will come true again and again, and Starbucks mission, values, and guiding principles will endure." Schultz added that CEO Kevin Johnson is a "true servant leader" who will lead the company as it "enters its next journey." Reference Link

16:23 EDT Starbucks names Mike Ullman new board chair, Mellody Hobson vice chair - Starbucks also announced that its board of directors has appointed Myron E. "Mike" Ullman as its new chair of the board and Mellody Hobson as vice chair of the board effective upon Schultz's retirement.

16:20 EDT Starbucks confirms Schultz stepping down as executive chairman - Starbucks announced that Howard Schultz is stepping down as executive chairman and member of the board of directors and will be honored with the title of chairman emeritus effective June 26, 2018. "I set out to build a company that my father, a blue-collar worker and World War II veteran, never had a chance to work for," Schultz wrote in a letter addressed today to past and present Starbucks partners. "Together we've done that, and so much more, by balancing profitability and social conscience, compassion and rigor, and love and responsibility."

16:17 EDT LCI Industries' Lippert Components acquires STLA for $15.4M - LCI Industrie, which, through its wholly-owned subsidiary, Lippert Components, supplies a broad array of engineered products for the leading original equipment manufacturers of leisure and mobile transportation and adjacent industries, and the related aftermarkets of those industries announced that it has acquired STLA s.r.l, a Pontedera, Italy-based manufacturer of bed-lifts and other recreational vehicle components for the European caravan market. STLA sales for 2017 were approximately $21M. The purchase price was $15.4M, which was paid at closing. After funding the acquisition, LCI remains well-positioned to take advantage of other investment opportunities.

16:15 EDT Lionsgate names Corii Berg as General Counsel - Lionsgate (LGF.A, LGF.B) has named media industry executive Corii Berg, a 20-year Sony Pictures (SNE) veteran, to be General Counsel, the Company announced. Berg will be the Company's senior legal and business affairs executive and serve on its Executive Management Committee and senior decision-making team. He will report to Lionsgate Chief Executive Officer Jon Feltheimer and will work closely with Vice Chairman Michael Burns, Lionsgate COO Brian Goldsmith and Lionsgate CFO Jimmy Barge. He starts at the Company next Monday, June 11th.

16:12 EDT American Campus enters LOI to develop, own housing for Disney College Program - American Campus Communities (ACC) announced that it has entered into a non-binding letter of intent to lease land from Walt Disney World Resort (DIS) in Lake Buena Vista, FL to develop and own housing for participants of the Disney College Program. ACC and Walt Disney World Resort are still negotiating the terms of a definitive agreement, and if ACC and Walt Disney World Resort are able to reach a definitive agreement, the new purpose-built housing will include ACC-designed units that offer a variety of configurations and price points that provide privacy and individuality for residents. If final negotiations are successfully concluded and a definitive agreement is executed, the parties will execute a ground lease conditioned upon the receipt of all necessary permits and final project feasibility. The $615M project is anticipated to be structured as an American Campus Equity transaction, whereby American Campus Communities will serve as the developer, manager and owner via a 75-year ground lease. Although the final scope, feasibility and timing have not been finalized, the company currently expects the development to be delivered in multiple phases, with the first phase scheduled for occupancy in May 2020 with full development completion in May 2023. Upon completion, the project is targeting a stabilized yield of 6.8%.

16:10 EDT Barclays CEO says no merger talks going on with Standard Chartered - Jes Staley said that scales matters, but mergers are "very disruptive" and it costs a lot of money to make them work. Commenting specifically on whether stories about Barclays (BCS) looking to merge with Standard Chartered (SCBFF) are realistic, Staley replied: "No, there is no discussion going on with Standard Chartered...We've spent a lot of time in the last two years restructuring this bank. We're done with restructuring. We had a terrific first quarter, so we're off to execute the strategy of Barclays." Barclays CEO Jes Staley made the comments earlier in an interview with CNBC's Wilfred Frost. Reference Link

16:10 EDT Scotts Miracle-Gro completes Sunlight Supply acquisition - The Scotts Miracle-Gro Company announced it has completed the acquisition of the assets of Sunlight Supply, enhancing the ability of SMG's wholly-owned subsidiary, The Hawthorne Gardening Company, to drive improved performance while meeting the needs of the rapidly evolving hydroponic products marketplace."This is an important and transformational moment for Hawthorne, for Sunlight and for hydroponic retailers and vendors everywhere," said Jim Hagedorn, chairman and chief executive of ScottsMiracle-Gro. "This combination reinforces our confidence in the future of hydroponic growing and creates unique competitive advantages for Hawthorne that we believe will take the industry to a new level."In fiscal 2018, the transaction is expected to be dilutive by 30c to 40c per share on a non-GAAP adjusted basis. The majority of the dilution is attributable to non-cash purchase accounting adjustments with the balance largely due to estimated deal costs, and increased interest expense.The company also announced it has formally launched 'Project Catalyst,' which it expects will achieve $35M in annual synergies for Hawthorne by the end of calendar 2019. Benefits from the transaction are expected to improve year-over-year non-GAAP adjusted earnings by 60c to 80c per share in fiscal 2019."We will move with both focus and urgency to achieve the synergies we have outlined and strengthen Hawthorne's financial performance," said Randy Coleman, chief financial officer. "We remain bullish on the long-term prospects for the hydroponic growing industry and Hawthorne's strengthened leadership position, but we also know we must deliver improved results as a result of the capital that has been dedicated to this effort. I am confident Project Catalyst will help us achieve our operating margin goal of 17 to 18 percent for this business while also positioning Hawthorne to adapt to the opportunities in the hydroponics industry."

16:07 EDT Worldpay names Asif Ramji as Chief Product Officer - Worldpay announce that it has appointed Asif Ramji to the role of Chief Product Officer, effective June 4. He will report to Executive Chairman & Co-CEO Charles Drucker and become a member of the company's Executive Committee.

16:03 EDT Black Knight acquires HeavyWater - Black Knight announced that it has acquired HeavyWater, a provider of artificial intelligence and machine learning, or AI and ML, to the financial services industry. Black Knight will be integrating AIVA into its premier solutions, while also making the technology available to clients who seek to deploy AI/ML within other parts of their organizations to help enhance efficiency, effectiveness and accuracy. By taking on manual tasks that have diverted resources away from value creation projects, AIVA reads, comprehends and draws conclusions based on context to mimic cognitive thinking and build expertise over time. Located in Philadelphia, HeavyWater has been providing this solution to help lenders verify income, assets and insurance coverage, which are traditionally manual activities that take hours to complete and are prone to error. Clients benefit from accelerated processes and reduced expenses as AIVA gains experience and manual routines are automated.

15:58 EDT Legg Mason agrees to pay $64M to resolve FCPA charges - Legg Mason has entered into a non-prosecution agreement with the Department of Justice and agreed to pay $64.2M to resolve the Department's investigation into violations of the Foreign Corrupt Practices Act in connection with Legg Mason's participation, through a subsidiary, in a Libyan bribery scheme, the DOJ announced. This payment includes a penalty of $32.625M to be paid to the U.S. Treasury within five days of the agreement, and disgorgement of $31.617M, which will be credited against disgorgement paid to other law enforcement authorities within the first year of the agreement. As part of the non-prosecution agreement, Legg Mason has agreed to continue to cooperate with the Department in any ongoing investigations and prosecutions relating to the conduct, including of individuals, to enhance its compliance program and to report to the Department on the implementation of its enhanced compliance program.

15:32 EDT Kandi Technologies trading resumes

15:12 EDT Apple previews latest version of macOS - Apple previewed macOS Mojave, the latest version of its desktop operating system. "In macOS Mojave, a new Dark Mode transforms the desktop with a dramatic new look that puts the focus on user content. The new Stacks feature organizes messy desktops by automatically stacking files into neat groups. Familiar iOS apps, including News, Stocks, Voice Memos and Home, are now available on the Mac(R) for the first time. FaceTime now adds support for group calling, and the Mac App Store(R) gets a full redesign featuring rich editorial content and the addition of apps from top developers, including Microsoft, Adobe and others," Apple stated. The developer preview of macOS Mojave is available to Apple Developer Program members starting today, and a public beta program will be available to Mac users in late June.

15:06 EDT Apple says not merging iOS and macOS operating systems

15:00 EDT Microsoft to bring Office 365 to Apple Mac App Store later this year

14:54 EDT Accenture launches innovation hub in Detroit, will add 200 jobs - Accenture launched an innovation hub in metro Detroit, which is designed to help companies in the automotive, industrial equipment, technology, energy and utilities industries address the shift to digital products and services; transform their engineering, manufacturing and field operations; and digitize their enterprises - which Accenture calls Industry X.0. Additionally, the company will add 200 highly skilled technology jobs to the local market by the end of 2020. "We welcome Accenture's decision to expand its commitments in the Detroit area and appreciate the highly skilled opportunities the company is creating for our talented workforce," said Governor Rick Snyder. "Accenture's investment is a testament to Michigan's history of innovation and our growing talent base."

14:47 EDT Innovus announces approval by Health Canada of ProstaGorx - Innovus Pharmaceuticals announced the approval by Health Canada of its product ProstaGorx as a Natural Health Product for the relief of urologic symptoms associated with mild to moderate benign prostatic hyperplasia. Innovus Pharma expects to launch ProstaGorx in the next few months through the company's website and its Canadian Beyond Human marketing and sales platform. "We are very delighted with the approval of ProstaGorx for the BPH indication in Canada," said Dr. Bassam Damaj, the President and Chief Executive Officer of Innovus Pharma. "We currently expect ProstaGorx to perform very well in Canada and look forward to its launch in the very near future. ProstaGorx when launched, will be the fourth product launched through our own sales and marketing commercial efforts in Canada in addition to Vesele, Apeaz and Xyralid and when launched will then be our eighth product on the Canadian market including Zestra, Zestra Glide and Uxor marketed by Orimed Pharma and UriVarx through our partnership with Acerus Pharmaceuticals Corporation. Another of the Company's products, AllerVarx, a supplement for allergic rhinits, has been approved by Health Canada, but has not yet launched."

14:45 EDT Apple previews tvOS 12, announces Charter collaboration - Apple previewed tvOS 12, which it calls "the powerful operating system designed for enjoying entertainment on the big screen, which takes the cinematic experience of Apple TV 4K to the next level with support for Dolby Atmos audio, convenient new features to easily access the shows and movies you love and breathtaking aerials shot from space." Apple also announced that Charter Communications (CHTR) will begin offering Apple TV 4K to their customers. Later this year, Charter's nearly 50 million customers will have access to Apple TV 4K via an all-new Spectrum TV app. In addition, as part of this collaboration, Charter will be offering iPhone and iPad to customers as they grow their mobile presence, Apple stated.

14:36 EDT Apple says Apple TV to integrate Charter content starting later this year

14:24 EDT Viacom announces Cyma Zarghami to step down as Nickelodeon Group President - Viacom announced that Cyma Zarghami is stepping down as President of Nickelodeon Group after more than thirty years with the network. While Viacom conducts a comprehensive search for a successor to lead Nickelodeon, Sarah Levy, Chief Operating Officer of Viacom Media Networks, will lead the brand on an interim basis.

14:20 EDT NewLink says final indoximod Phase 2 data shows 'encouraging' response rates - NewLink Genetics announced that data from two Phase 2 studies of indoximod, used in combination with other agents, were presented at the 2018 American Society of Clinical Oncology Annual Meeting. "Our data in advanced melanoma suggest that indoximod in combination with checkpoint blockade shows encouraging response rates potentially in both PD-L1 positive and negative patients," said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer. "We wish to thank the patients and their caregivers who participated in both of these studies." Results from a single-arm Phase 2 study of indoximod in combination with checkpoint inhibitors for patients with advanced melanoma were presented today by Yousef Zakharia, MD, Assistant Professor of Medicine, Division of Hematology, Oncology and Blood & Marrow Transplantation at the University of Iowa and Holden Comprehensive Cancer Center. In this study, of 102 total patients enrolled, 101 patients with advanced melanoma were treated with indoximod plus standard-of-care checkpoint inhibition as approved for melanoma. 70 patients with cutaneous or mucosal melanoma were treated with pembrolizumab plus indoximod and had an on-treatment imaging, meeting the per-protocol, pre-specified definition of evaluable for efficacy. Of the remaining 32 patients, 15 had uveal melanoma, 4 received ipilimumab, 4 received nivolumab, and one patient was never treated. In addition, 8 patients came off study prior to the first on-treatment imaging study.

14:19 EDT Dynavax reports data for Phase 1b/2 trial of SD-101 in combination with Keytruda - Dynavax Technologies (DVAX) announced data from its ongoing Phase 1b/2 study investigating SD-101, Dynavax's intratumoral TLR9 agonist, in combination with KEYTRUDA, an anti-PD-1 therapy developed by Merck (MRK) in patients with advanced melanoma. The company reported results on a total of 69 patients comparing two doses of SD-101, less than or equal to 2mg versus 8mg administered by intratumoral injection. These data are being presented in poster and discussion session today at the 2018 American Society of Clinical Oncology Annual Meeting. The primary endpoints of this dose-expansion/dose-finding study are safety and preliminary efficacy. The results of this study showed a 70% overall response rate in advanced melanoma patients who received the less than or equal to 2 mg dose of SD-101 in up to four lesions versus a 38% ORR in the group receiving the 8 mg dose of SD-101 in one lesion. The combination of SD-101 and KEYTRUDA was well tolerated with adverse events related to SD-101 being transient, mild to moderate flu-like symptoms."These data provide further evidence of the potential for SD-101 to improve responses in first-line advanced melanoma patients in combination with an anti-PD-1 therapy. Our studies continue to demonstrate the potential value of SD-101 across multiple tumor types. We plan to build upon this momentum and update our progress with additional data planned for a medical conference later in the year," said Dynavax CEO Eddie Gray.

14:16 EDT Apple introduces iOS 12 with AR, Memoji and Group FaceTime features - Apple announced iOS 12, the latest version of its mobile operating system, which the company said is "designed to make everyday tasks faster and more responsive." iOS 12 "changes the way iOS users see the world using AR, makes communications fun and expressive with Memoji and Group FaceTime, and with Screen Time, helps customers understand and take control of the time they spend interacting with their iOS devices. iOS 12 introduces Siri Shortcuts, enabling Siri to work with any app, delivering a much faster way to get things done," Apple stated. The developer preview of iOS 12 is available to Apple Developer Program members starting today, and a public beta program will be available to iOS users later this month. iOS 12 will be available this fall as a free software update.

14:11 EDT Analyst calls end of 'retailpocalypse,' gets bullish on Macy's - Evercore ISI analyst Omar Saad flipped his Macy's (M) short position to a long position in his model portfolio, citing improved customer engagement through a revamped and expanded loyalty program, omni-channel capabilities, and more open-sell formats. Overall, the analyst is convinced that old-world brands and retailers are figuring out how to manage inventory and market to consumers in the digital era, a critical turning point for the sector. 'RETAILPOCALYPSE' IS OVER: In a research note to investors, Evercore ISI analyst Omar Saad said he is extending his bullish view beyond the fashion/athletic/luxury brands he covers to also encompass the broader Softlines universe, including department stores and specialty retailers. The analyst argued that he is convinced that old-world brands and retailers are figuring out how to manage inventory and market to consumers in the digital era, a critical turning point for the sector. While the benefits of digitally-enabled, central-view inventory management are subtle, they are also "powerful," he contended. As demand increasingly shifts online, the analyst noted that retailers will be able to generate more revenue with less goods, which also means faster inventory turns, less working capital requirements, stronger cash flows, more frequent newness and innovation, and less markdowns, all healthy dynamics that have already started emerging. Additionally, Saad told investors that he believes multi-year share price underperformance and still modest valuations despite a "very healthy" consumer macro environment means the market is still married to the "retailpocalypse" narrative which assumes that Amazon (AMZN) and other digital disruptors will continue unabated in their assault on traditional Softlines players, a viewpoint with which he no longer agrees. The digital revolution has "wreaked tremendous havoc" on Softlines, but the rampant discounting, pricing pressure, elevated inventories, and overall P&L pressure across the sector since 2014 has been broadly misinterpreted as digital disintermediation, the analyst contended. Rather, he thinks that the bloated inventories resulted from Softlines companies building stock for both stores and e-commerce, new digital players building their own inventory, as well as the general need for less inventory given the central pool effect. All of this led to rampant on-line clearance by both brands and retailers, which in turn completely undermined full-price selling as digitally savvy consumers easily figured out how to get the best deals, a strategy that he thinks most retailers and brands now realize is unsustainable. 7% LONG POSITION ON MACY'S: Evercore ISI's Saad flipped his Macy's 7% short position to a 7% long position in his model portfolio. Saad said Macy's has improved customer engagement through a revamped and expanded loyalty program, leveraging social media, rolling out omni-channel capabilities, and testing more open-sell formats. Macy's is the "quintessential old-world retailer that the majority of the investment community has left for dead," but that can now unlock tremendous equity value using new-world inventory management and digital marketing/engagement platforms as it continues on the path of creatively re-imagining the traditional department store, he contended. The analyst added that he believes the market underappreciates Macy's access to strong brands, low/no-cost prime real estate, heritage/household name, and local shipping potential, while starting to figure out digital marketing, engagement and data. OTHER CHANGES: In addition to "double upgrading" Macy's in the portfolio, Saad closed short positions in Kohl's (KSS) and Dick's Sporting (DKS) while closing a long position in Ross Stores (ROST). PRICE ACTION: In afternoon trading, shares of Macy's have gained over 3% to $36.69.

14:05 EDT Apple CEO Tim Cook says Apple Watch is #1 in customer satisfaction since launch

14:01 EDT ReShape Lifesciences provides clarifying details to FDA letter - ReShape Lifesciences (RSLS) provided an explanation and clarifying details to a letter dated June 4, 2018 that the U.S. FDA posted on their website addressed to Health Care Providers. The FDA letter updates the agency's August 10, 2017 letter regarding the potential risks of death associated with liquid-filled intragastric balloons manufactured by Apollo Endosurgery (APEN) and ReShape Lifesciences. FDA's most recent communication updates the healthcare community regarding additional reports of deaths they have received since August 2017 and discusses the collaborative effort taken with industry to understand these occurrences and enhance product labeling accordingly. In relation to the ReShape Balloon, the facts are:ReShape Balloon is approved by the FDA as safe and effective for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index of 30 - 40 kg/m2 and one or more obesity-related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone. There has been one reported death of a patient implanted with a ReShape Balloon since the August 10, 2017 letter from FDA; The patient death was due to a pulmonary embolization secondary to a surgical repair of a gastric perforation; ReShape has received no product liability-related claims in connection with this case. "Patient safety is our highest priority at ReShape Lifesciences, and safety was the main driver behind the unique dual balloon design of our ReShape Balloon," stated Dan Gladney, Chairman and CEO of ReShape Lifesciences. "We worked closely with FDA to review and enhance our Instructions for Use patient information and physician training materials and we will continue to work with the FDA to mitigate patient risk and optimize outcomes so that we can continue to safely and effectively change lives with our obesity solutions."

13:54 EDT Apple announces launch of 'Memoji' personalized animojis

13:47 EDT Blue Apron moves higher after meal-kit rival HelloFresh partners with Ahold - Earlier today, meal kit company and Blue Apron (APRN) rival HelloFresh announced that it will begin selling its kits in Ahold Delhaize's (ADRNY) Giant Food and Stop & Shop stores. "As an independent food brand, HelloFresh will partner to increase its availability with more retailers throughout the year, including revitalizing the grab and go aisles for smaller format retail chains," said the company in a statement. RECENT MEAL-KIT PARTNERSHIPS: Recently, big grocery chains have tried to position themselves in the omnichannel food retail market. Just last month, Kroger (KR) and private meal kit company Home Chef announced a merger agreement that will significantly accelerate the availability of meal kits and position the combined company to "lead the way in revolutionizing how families shop for, prep, and cook their meals." Also in May, Blue Apron said that it has started selling its meal kits at Costco (COST) stores at a discount of nearly 30% off the price of its regular subscription service. Albertson's, which was taken private, announced the acquisition of meal kit company Plated last year. THE AMAZON EFFECT: Last year, Amazon (AMZN) closed on its deal to acquire Whole Foods, posing a threat to the brick and mortar retail grocery business. As has been widely reported in recent years, the traditional brick and mortar retail landscape is experiencing significant upheaval, partly due to the Amazon Effect. Apparently the brick and mortar grocery business is also feeling the pain of other retailers. Early this year, supermarket chain Tops Markets filed for bankruptcy, citing falling food prices and competition from Amazon. Southeastern Grocers, the parent company of Bi-Lo, Winn-Dixie and other supermarket brands announced it had entered a Restructuring Support Agreement with a group of creditors. PRICE ACTION: Shares of Blue Apron are up 3.5% in afternoon trading to $3.30 per share.

13:40 EDT Siemens Healthineers says FDA clears Biograph Vision PET/CT system - The FDA has cleared the Biograph Vision, a new positron emission tomography/computed tomography system from Siemens Healthineers that "delivers a new level of precision in PET/CT imaging."

13:21 EDT Apple announces Measure augmented reality app for iOS devices

13:17 EDT Apple creates new file format for augmented reality with Pixar

13:14 EDT Apple says iOS 12 will be available on all devices that support iOS 11

13:05 EDT PSA starts to suspend joint venture activities in Iran - The company said, "After signature of the JCPOA on July 14th, 2015 and the lifting of international sanctions against Iran on January 16th, 2016, Groupe PSA signed joint venture agreements with Iran Khodro on June 21th, 2016 and Saipa on October 6th, 2016. The purpose of these JVs, which are fully compliant with UN resolutions and current US, European and French regulation, is to offer Iranian customers modern Peugeot and Citroen vehicles, designed to the highest level of safety, comfort and environmental protection. Following the US withdrawal from the JCPOA announced on May 8th, 2018, the Group has begun to suspend its JVs activities, in order to comply with US law by August 6th, 2018. With the support of the French Government, the Groupe PSA is engaging with the US authorities to consider a waiver. Groupe PSA is monitoring the regulatory context and is in contact with the authorities of the countries concerned, in order to remain compliant with all regulations. As Groupe PSA's operations in Iran represent less than 1% of its turnover, this context does not alter the overall objectives of the Push to Pass plan, nor current financial guidance." Reference Link

12:53 EDT PlayStation 4 to have 'select content' first for 'Read Dead Redemption 2' - Take-Two's (TTWO) Rockstar Games announced details for the Special Edition and Ultimate Edition of its upcoming game "Red Dead Redemption 2," along with extra pre-order bonuses for all three versions and a unique assemblage of real-world collectibles inspired by the game. While the game is launching on Xbox One (MSFT) and PlayStation 4 (SNE), however, the PlayStation Store page for the game said that "select content" for the game will be available exclusively on PlayStation 4 first.

12:08 EDT AeroVironment to sell Efficient Energy Systems business segment for $35M - Webasto Group and AeroVironment announced Webasto's agreement to acquire AeroVironment's Efficient Energy Systems business segment for $35M, subject to customary post-closing adjustments and indemnification agreements. Webasto will retain all existing EES employees. "We conducted a very robust process in which we identified a number of potential strategic acquirers for our EES business. We found Webasto's E-mobility strategy to be highly aligned with that of EES, and our respective capabilities to be highly complementary serving our end markets. Our strategic divestiture of EES helps AeroVironment focus on our leading small UAS, Tactical Missile Systems, High-Altitude Pseudo-Satellite, and Commercial Information Solutions businesses, each of which represents significant investment and long-term growth potential," said Wahid Nawabi, AeroVironment CEO.

11:32 EDT Atlassian under pressure after Microsoft agrees to buy GitHub - Microsoft (MSFT) announced this morning that it has reached an agreement to acquire GitHub, a private company whose web-based hosting service for version control using git is mostly used for computer code. Commenting on the news, Evercore ISI analyst Kirk Materne called the move a "smart strategic deal." Voicing a similar opinion, his peer at Oppenheimer argued that the deal puts pressure on other siloed DevOps tool companies, with Atlassian (TEAM) being among the most affected as it has a competing SCM solution that ties closely to its collaboration/workflow platform. GITHUB ACQUISITION: Microsoft announced it has reached an agreement to acquire GitHub. Under the terms of the agreement, the former will acquire the latter for $7.5B in Microsoft stock. Subject to customary closing conditions and completion of regulatory review, the acquisition is expected to close by the end of the calendar year. "GitHub will retain its developer-first ethos and will operate independently to provide an open platform for all developers in all industries," Microsoft stated in its announcement confirming the deal. Upon closing, Microsoft expects GitHub's financials to be reported as part of the Intelligent Cloud segment. Microsoft expects the acquisition will be accretive to operating income in fiscal year 2020 on a non-GAAP basis, and to have minimal dilution of less than 1% to earnings per share in fiscal years 2019 and 2020 on a non-GAAP basis, based on the expected close time frame. An incremental share buyback, beyond Microsoft's recent historical quarterly pace, is expected to offset stock consideration paid within six months after closing. Microsoft will use a portion of the remaining $30B of its current share repurchase authorization for the purchase. 'SMART STRATEGIC DEAL': In a research note to investors this morning, Evercore ISI's Materne highlighted that GitHub is a key platform for most corporate software developers and said he sees Microsoft's purchase as a "smart strategic deal" to double down on developers. While the deal will be largely immaterial to Microsoft's bottom line, the analyst thinks the acquisition will give Microsoft, and Azure, an even more prominent position in the developer community. Further, Materne argued that GitHub provides Microsoft with additional credibility among open source developers and gives Microsoft an opportunity to cross sell additional services like Teams and Cosmo into the developer community. The analyst reiterated an Outperform rating and $120 price target on Microsoft shares. ATLASSIAN THE MOST AFFECTED: Also commenting on the news, Oppenheimer analyst Ittai Kidron told investors in a research note of his own that the move illustrates Microsoft's intentions to deepen its influence on the DevOps community, commitment to open source software, and efforts to deliver a seamless end-to-end application development life-cycle experience. Further, the analyst believes the deal solidifies Microsoft market position, puts pressure on other siloed DevOps tool companies, and can drive further consolidation. From his coverage, Kidron thinks Atlassian is the most affected as it has a competing software configuration management, or SCM, solution that ties closely to its collaboration/workflow platform. He expects Atlassian to consider acquisitions of application release automation and continuous configuration automation tools in response. PRICE ACTION: In late morning trading, shares of Microsoft have gained about 1% to $101.54, while Atlassian's stock has dropped about 1% to $63.34.

11:19 EDT Walgreens completes sale of a 30% interest in Guangzhou Pharmaceuticals - Walgreens Boots Alliance announced that, following receipt of regulatory approvals, it has completed the previously announced sale of a 30% interest in Guangzhou Pharmaceuticals Corporation to its joint venture partner Guangzhou Baiyunshan Pharmaceutical. Walgreens will continue to account for its remaining 20% stake in Guangzhou Pharmaceuticals as an equity method investment.

11:01 EDT Perion Network regains compliance with Nasdaq's minimum bid price requirement - Perion Network announced it received formal notification from The Nasdaq Stock Market that the company has regained compliance with the minimum bid price requirement. As previously disclosed, the company was notified by Nasdaq on March 27, 2017 that it no longer satisfied the minimum bid price requirement for continued listing. In a letter dated May 31, 2018, Nasdaq notified the company that it has regained compliance with Listing Rule 5450(a)(1) and that the matter is now closed.

10:41 EDT Analyst cuts solar stocks ratings on 'much worse' Chinese new policy - Roth Capital analyst Philip Shen downgraded JinkoSolar (JKS) and JA Solar (JASO) to Sell, and Amtech Systems (ASYS) and Daqo New Energy (DQ) to Neutral. This comes after China's NEA released its Solar Management Plan, which the analyst believes is "much worse than expected" and will result in a "massive" net oversupply of cell capacity. CHINA'S NEW SOLAR POLICY: Roth Capital's Philip Shen told investors that China's NEA has released its anticipated "Solar Management Plan," which he believes is more severe than he had expected with potentially negative consequences for traditional utility scale and distributed generation demand in 2018. It appears traditional utility scale projects will not be eligible for the 2018 FIT until an update is provided, and 2018 DG demand will be capped at 10GW, he highlighted. Additionally, Shen noted that 2018 FITs for utility scale projects and fully-connected to the grid DG projects were lowered by about 6%-9%. SELL JINKOSOLAR, JA SOLAR: In a separate research note, Roth's Shen downgraded JinkoSolar to Sell from Neutral, citing China's new solar policy released last Friday, which he called "much worse than expected." Given the new policy, the outlook for module ASPs has "suddenly deteriorated" for not only 2018, but also 2019, Shen contended, while lowering his price target on the shares to $12 from $19. Citing similar reasons, the analyst also downgraded JA Solar to Sell from Neutral as he expects a "massive net oversupply." While Shen acknowledged that JA Solar's merger agreement was approved, he sees risk to shares if the agreement is not successfully completed. The analyst also lowered the price target on JA Solar's shares to $5.80 from $6.70. MOVING TO THE SIDELINES ON AMTECH, DAQO: Also more bearish on two other names, Shen cut Amtech Systems and Daqo New Energy's ratings to Neutral from Buy, citing a "much worse than expected new solar policy" and a "massive" net oversupply of cell capacity. The analyst told investors he believes the outlook for additional orders for Amtech Systems has deteriorated for 2018 and 2019, and pointed out that he foresees a similar scenario for polysilicon prices. Daqo New Energy's stock should get hit as poly pricing falls, he added. Shen lowered his price target for Amtech Systems to $9 from $15, and for Daqo New Energy to $48 from $75. PRICE ACTION: In morning trading, shares of JinkoSolar have dropped 14% to $13.02, Amtech Systems' stock has slipped 14.5% to $8.48, and Daqo New Energy has slid about 21% to $41.58. Meanwhile, JA Solar is fractionally up to $7.17. OTHERS TO WATCH: Also trading lower in the space are Canadian Solar (CSIQ), First Solar (FSLR), and Hanwha Q Cells (HQCL).

10:27 EDT Acacia Research urges stockholders to vote for its director nominees - Acacia Research Corporation announced that it has mailed a letter to stockholders reiterating why Acacia's two director nominees, Louis Graziadio and Frank "Ted" Walsh, are the right Board members to guide the company forward. The company said, "In the letter, Acacia's two nominees reflect on their experiences on the Acacia Board, the company's transformation and the future of Acacia. Acacia's two director nominees have been critical to driving Acacia's strategy and play an instrumental role in the day-to-day operations of the Company. The Board believes that replacing its successful, dedicated investor-directors, who have purchased approximately $7M worth of Acacia stock in the open market with their own funds, with Mr. Alfred Tobia and Mr. Clifford Press, the two nominees put forward by stockholder activists, will do lasting harm to Acacia and put your investment at risk. Stockholders are reminded that the 2018 Annual Meeting of Stockholders is rapidly approaching and will be held on June 14, 2016. Each vote is important and the Board recommends that stockholders vote for Mr. Graziadio and Mr. Walsh on the WHITE proxy card today." The letter and other important information related to the Annual Meeting can be found on Acacia's website.

10:12 EDT Summit Partners announces acquistion of Advance Medical by Teladoc - Global growth equity investor Summit Partners announced that Advance Medical has been acquired by Teladoc. Summit made a minority investment in Advance Medical in January 2018. Founded in 1999 by Marc Subirats and Carlos Nueno, Advance Medical is a worldwide leader in telemedicine and expert medical opinion services. The acquisition of Advance Medical expands Teladoc's international footprint, broadens its breadth of medical services and its physician network, and extends the company's market leadership. Teladoc completed its acquisition of Advance Medical on May 31, 2018. The purchase price consists of approximately $292M in cash and $60M of Teladoc common stock.

09:56 EDT Merck KGaA says trial shows continued durable responses with BAVENCIO - Merck KGaA (MKGAF) and Pfizer Inc. (PFE) announced that updated efficacy and safety data from the pivotal JAVELIN Merkel 200 trial of BAVENCIO in patients with metastatic Merkel cell carcinoma will be presented as an oral abstract session at the 54th American Society of Clinical Oncology Annual Meeting on Monday, June 4 from 10:12-10:24 a.m. CDT in Chicago, IL. At this two year follow-up update of the pivotal study, BAVENCIO continues to demonstrate clinically meaningful durable responses and stable rates of progression-free survival and overall survival from previous analyses in patients who responded to this treatment. Clinical activity was observed across all patient subgroups, irrespective of PD-L1 expression in tumor tissue or Merkel cell polyomavirus status. The safety profile for BAVENCIO in this trial has not changed with longer follow-up and remains consistent with that observed in the overall JAVELIN clinical development program. In JAVELIN Merkel 200 - an open-label, single-arm Phase II study - patients with histologically confirmed mMCC whose disease had progressed on or after chemotherapy administrated for distant metastatic disease received BAVENCIO 10 mg/kg intravenously every two weeks until disease progression or unacceptable toxicity. Eighty-eight patients were followed for a median of 29.2 months. The confirmed overall response rate of 33% remained unchanged from previous analyses reported at both one year and 18 months. Responses remained ongoing in 19 of 29 patients who responded to treatment, including 12 patients whose duration of response exceeded two years. Durable responses led to stable rates of PFS. Median OS was 12.6 months and the two-year OS rate was 36%. With a minimum follow-up of two years, no new safety signals were identified for BAVENCIO and was consistent with prior reports. Sixty-seven patients had a treatment-related adverse event, 10 patients had a Grade 3 or less TRAE and 20 patients had an immune-related adverse event. No treatment-related deaths occurred. In addition to these updated JAVELIN Merkel 200 data, results from a global expanded access program for BAVENCIO as a second-line treatment for patients with mMCC will be presented. These data will be presented during a poster session on Monday, June 4 from 1:15-4:45 p.m. CDT. The alliance's JAVELIN clinical development program involves at least 30 clinical programs, including seven Phase III trials, and nearly 8,300 patients across more than 15 tumor types. BAVENCIO was first approved in the US in 2017 by the US Food and Drug Administration for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma. In addition to the FDA accelerated approval in mMCC, avelumab is also approved in the US under accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

09:50 EDT Trump says trade barriers against U.S. farmers will end - President Trump just tweeted, "Farmers have not been doing well for 15 years. Mexico, Canada, China and others have treated them unfairly. By the time I finish trade talks, that will change. Big trade barriers against U.S. farmers, and other businesses, will finally be broken. Massive trade deficits no longer!" Publicly traded companies in the agriculture space include Agrium (AGU), Andersons (ANDE), Archer Daniels (ADM), Bunge (BG), CF Industries (CF), Changed to DWDP (DD), Compass Minerals (CMP), Intrepid Potash (IPI), Monsanto (MON), Mosaic (MOS), Potash (POT) and Syngenta (SYT).

09:39 EDT Atlassian drops after Microsoft confirms acquisition of GitHub - Shares of Atlassian (TEAM) are falling in early trading after Microsoft (MSFT) announced it has reached an agreement to acquire GitHub for $7.5B in Microsoft stock. Oppenheimer analyst Ittai Kidron has said he thinks Atlassian is most affected among the stocks in the space that he cover, as it has a competing SCM solution that ties closely to its collaboration/workflow platform. In early trading after Microsoft confirmed the GitHub deal, Atlassian shares are down 1.6% to $62.99.

09:30 EDT Stifel Financial names Michael O'Keeffe Chief Investment Officer - Stifel Financial announced that Michael O'Keeffe has been named Chief Investment Officer and Head of Investment Strategy of its broker-dealer subsidiary, Stifel, Nicolaus & Company, Incorporated. In this role, he will lead the team responsible for developing investment strategy and corresponding investment solutions for the financial advisors and clients of Stifel's Private Client Group. O'Keeffe joined Stifel in 2013.

09:29 EDT MasTec awarded $500M contract with PREPA - MasTec announced that it has signed a master services agreement with the Puerto Rico Electric Power Authority to complete the restoration of the critical electrical transmission and distribution system components damaged as a result of Hurricane Maria as well as to support the initial phase of reconstruction and modernization of the electrical power system in Puerto Rico. The master services agreement award has an estimated value of $500M. Services under this contract are expected to be completed over the upcoming 12 months, once MasTec completes the process of remobilizing crew and equipment resources to Puerto Rico. Under the terms of the contract, MasTec is to perform hurricane restoration and reconstruction services at various locations in PREPA's service area. As the restoration process comes to an end, MasTec will continue to work with the Commonwealth of Puerto Rico, PREPA and various other federal and Commonwealth agencies in the transition to upgrading and modernizing the Puerto Rico power grid.

09:26 EDT Victory Capital announces expanded relationship with Nasdaq - Victory Capital (VCTR) announced that Nasdaq (NDAQ) will begin serving as the calculator, publisher and administrator for its proprietary CEMP indexes, which are the benchmarks for the firm's volatility-weighted VictoryShares ETFs. The change will be effective on June 18, 2018, for the 12 domestic and international equity indexes, and in mid-September for the two emerging market equity indexes. All of the CEMP volatility weighted indexes will be rebranded "Nasdaq Victory Volatility Weighted Indexes" as of June 18, 2018. Nasdaq already calculates and publishes the Nasdaq Victory indexes for the VictoryShares Multi-Factor Minimum Volatility and Dividend Growth ETF offerings.

09:24 EDT BAE Systems names Peter Trainer general manager of Air Force Solutions - BAE Systems announced the hiring of Peter Trainer as the vice president and general manager of its Air Force Solutions business area. Trainer, a long-time defense executive and career U.S. Air Force officer, will lead a unit that provides the Air Force and combatant commands with innovative solutions to help modernize, maintain, test, and cyber-harden aircraft, radars, missile systems, and mission applications that detect and deter threats to national security.

09:22 EDT Kilroy Realty signs leases totaling 945,000 square feet - Kilroy Realty Corporation said it has signed new or renewing leases on approximately 945,000 square feet of space at several of its stabilized properties during the past month. Rents on the leases are up approximately 26% on a GAAP basis and 6% on a cash basis. The average lease term is approximately nine years. The leases span three of the company's four major markets: San Diego, Seattle and San Francisco. In San Diego, the company signed multiple leases, including a 145,000-square-foot lease with General Atomics at its Kilroy Sabre Springs property on the I-15 Corridor, backfilling a large lease expiration scheduled for July. At Del Mar Corporate Center, the company signed 48,000 square feet of leases to backfill a 127,000-square-foot expiration scheduled for October. In Seattle, the company executed a 163,000-square-foot lease renewal and extension with Adobe at Fremont Lake Union Center. And in San Francisco, the company signed multiple leases, including a new lease with Nektar Therapeutics for up to 136,000 square feet at 360 Third Street and a new lease with a technology company for approximately 375,000 square feet at 301, 333 and 345 Brannan Street. 333 Brannan Street is a 185,000-square-foot ground-up, LEED Platinum office project, developed by KRC in 2015; 301 Brannan Street is an 83,000-square-foot historic office property that was purchased by the company in 2011; and 345 Brannan Street is a 110,000-square-foot office project that KRC is in escrow to purchase later this year.

09:19 EDT Voce reiterates call for removal of Natus chairman Robert Gunst - Voce Capital Management, a long-term owner of Natus Medical Incorporated and the owner of approximately 2.2% of its shares outstanding, reiterated its call for the removal of Natus Chairman Robert Gunst by stockholders at the upcoming Annual Meeting of Stockholders on June 22, 2018. Voce provided the following statement: "For the past several weeks, Voce has been open and transparent with our fellow stockholders regarding our very serious reservations about the strategy and leadership of Natus. This included a lengthy public letter on April 23, 2018, and culminated with our release of a detailed whitepaper on May 30. One of our most consistent and pressing concerns has centered on the tenure, qualifications and track record of Chairman Robert Gunst, who we believe is directly responsible for Natus' problematic corporate governance and who we further believe is a bulwark against any meaningful change at Natus. Natus has failed to address, and in no way refutes, the comprehensive analysis supplied in our 102-page whitepaper. Perhaps most notably, however, Natus hasn't even acknowledged our myriad criticisms of Chairman Gunst's suitability as a Natus Director generally, and as its Independent Chairman, specifically. Our interactions with the Board have convinced us that there can be no meaningful change at Natus without a change in the chairmanship of the Board...Natus' current Board structure, practices and leadership represent a bygone era of imperiousness, entitlement and unaccountability by insiders that offend the contemporary canon of corporate governance. To help restore credibility and integrity to Natus' Board, Voce has nominated three independent, highly-qualified Nominees. They bring substantial, relevant medical device experience and fill crucial skill-gaps in sales, marketing, product development, strategy and clinical and regulatory affairs, all of which are areas where Natus has shown significant deficiency. Given their prior Board tenures and service as named executive officers in public companies, the Nominees possess significant corporate governance expertise that will help usher Natus' Board into the modern age. They will do so by refocusing the Board on its fundamental responsibility - to represent the best interests of stockholders - through tight alignment, transparency and accountability. We note that two of the Nominees are already owners of Natus shares. The 2018 Annual Meeting is scheduled to be held on June 22, 2018. Voce urges its fellow stockholders to vote on the BLUE proxy card FOR its highly-qualified, independent Nominees and FOR its Removal Proposal to remove Chairman Robert Gunst from the Board. "

09:18 EDT American Electric Tech. announces $14M project with EPC firm - American Electric Technologies announced today that its M&I Electric business has been awarded a $14M contract to provide a turnkey power delivery solution for a fractionation plant expansion project in Texas. The company received the award from a leading Engineering, Procurement and Construction, or EPC, firm responsible for the design and delivery of this project to expand fractionation capacity for their midstream project customer.

09:16 EDT ResMed-sponsored study on bilevel PAP presented at SLEEP - A new study reveals that shifting patients who are struggling with adherence to positive airway pressure therapy to a more advanced bilevel device in the first 90 days of treatment is an effective tool for achieving adherence in well more than half of such cases. This research, sponsored by ResMed was presented this week at SLEEP, an annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society. Patients diagnosed with sleep apnea are usually prescribed a PAP device that provides either continuous or auto-adjusting pressure. A bilevel device delivers two distinct pressures, one for inhalation and one for exhalation. Physicians may prescribe bilevel for patients who are pressure intolerant or have continued evidence of apnea at higher pressures. In this "Bilevel Rescue" study, ResMed compared 1,496 non-compliant patients who switched to bilevel therapy and found that compliance was achieved by: 58.5 percent of patients who switched before day 60, 54.2 percent of patients who switched between days 60-90 and 56.8 percent of patients overall.

09:13 EDT Park City Group engages Hayden IR to lead strategic investor relations - Park City Group has engaged Hayden IR to lead its strategic investor relations effort. Hayden IR is a highly regarded investor relations consulting firm known for its ability to connect under-followed and undervalued emerging growth companies with sophisticated institutional investors, buy-side and sell-side analysts, retail brokerage firms and accredited individual investors.

09:11 EDT CIT Group completes initiatives to simplify mortgage operations - CIT Group announced that it completed key strategic initiatives to simplify its mortgage operations and reduce risk. The company completed the sale of its Financial Freedom reverse mortgage servicing business and the related reverse mortgage portfolio to an undisclosed buyer. The transaction included the sale of mortgage servicing rights and $879M of reverse mortgage whole loans and other real estate owned assets as of April 30, 2018. In addition, CIT has outsourced the payment, servicing and administration of duties of its ongoing mortgage portfolio to a leading national provider of residential servicing. The portfolio is approximately $5.2B as of March 31, 2018.

09:10 EDT Gilead announces clinical responses observed with investigational TCR - Kite, a Gilead company announced results from an ongoing Phase 1 study conducted by the National Cancer Institute, or NCI, showing that clinical responses were observed with investigational T cell receptor, or TCR, cell therapy targeting human papillomavirus type 16 E7 in solid tumor cancers caused by HPV. These findings were presented today in a poster session at the 2018 American Society of Clinical Oncology, or ASCO. In this study, eight patients with metastatic HPV-16 cancers received a single infusion of gene-engineered E7 T cells at one of three dose levels. Patients had received between three and seven prior lines of systemic cancer therapy. In the initial six patients, the E7 TCR was expressed by 90-99 percent of the infused T cells, and E7 T cells were detectable in the peripheral blood six weeks following treatment. The study is ongoing. Partial responses were observed in three out of the seven evaluable patients and another two patients had stable disease. To date, the responses have lasted as long as nine months and have occurred in patients with vulvar, oropharyngeal and anal cancer. Two of these patients had been previously treated with anti-PD1 checkpoint blockade.

09:09 EDT Seattle Genetics highlights additional analyses from Phase 3 ECHELON-1 trial - Seattle Genetics highlighted data from the phase 3 ECHELON-1 clinical trial evaluating ADCETRIS in combination with chemotherapy in newly diagnosed stage III or IV classical Hodgkin lymphoma at the 2018 American Society of Clinical Oncology Annual Meeting being held June 1-5 in Chicago, Illinois. In March 2018, the U.S. Food and Drug Administration approved ADCETRIS in combination with chemotherapy for the treatment of adult patients with previously untreated stage III or IV classical HL based on the positive results of the phase 3 ECHELON-1 clinical trial. ADCETRIS is being evaluated globally as the foundation of therapy for HL in more than 50 ongoing clinical trials, including trials led by Seattle Genetics and its development and commercialization partner, Takeda, as well as by independent investigators. Three poster presentations highlight analyses from the ECHELON-1 phase 3 clinical trial evaluating ADCETRIS in combination with AVD in stage III or IV frontline classical HL patients. The ECHELON-1 poster presentations include the results of the North American patient population, optimizing therapy with the use of primary prophylactic growth factors and improvement of modified progression-free survival outcomes in patients who received ADCETRIS plus AVD regardless of cycle 2 PET status. In addition, long-term follow-up from an ongoing phase 2 clinical trial in newly diagnosed older HL patients was reported. Of the 1,334 advanced stage classical HL patients who participated in the ECHELON-1 clinical trial, 497 patients were treated in North America, with 250 patients in the ADCETRIS plus AVD arm and 247 patients in the ABVD control arm. The North American results presented by Dr. Radhakrishnan Ramchandren, Barbara Ann Karmanos Cancer Center, are included below and a video summary of the poster presentation can be found here: Per Independent Review Facility assessment, the two-year modified PFS rate for patients in the ADCETRIS plus AVD arm was 84.3 percent compared to 73.7 percent in the control arm, which corresponds to a difference of 10.6 percent. Per investigator assessment, the two-year modified PFS rate for patients in the ADCETRIS plus AVD arm was 86.4 percent compared to 73.6 percent in the control arm, which corresponds to a difference of 12.8 percent. Per investigator assessment, the two-year PFS rate for patients in the ADCETRIS plus AVD arm was 88.1 percent compared to 76.4 percent in the control arm, which corresponds to a difference of 11.7 percent. Consistent improvement in modified PFS per IRF was observed among patients treated with ADCETRIS plus AVD compared with ABVD across all pre-specified subgroups, including age, disease stage, International Prognostic Score and baseline ECOG score. On the ADCETRIS plus AVD arm, peripheral neuropathy events were observed in 80 percent of patients compared to 56 percent on the ABVD arm. In the ADCETRIS plus AVD arm, the majority of peripheral neuropathy events were Grade 1 or 2. Grade 3 events were reported in 17 percent of patients. In the ABVD arm, Grade 3 events were reported in less than one percent of patients. There were no Grade 4 events on either arm. Across both arms of the study, approximately 75 percent of the patients with peripheral neuropathy reported resolution or improvement at last follow-up. Febrile neutropenia during treatment was reported in 20 percent of patients in the ADCETRIS plus AVD arm compared with nine percent in the ABVD arm. In the ADCETRIS plus AVD arm, 35 patients received primary prophylactic G-CSF within five days of starting treatment and nine percent reported febrile neutropenia. Pulmonary toxicity was reported in three percent of patients in the ADCETRIS plus AVD arm versus ten percent of patients in the ABVD arm. Grade greater than or equal to3 events were reported in two percent versus six percent of patients, in the ADCETRIS plus AVD and ABVD arms, respectively. During the ECHELON-1 clinical trial, an independent monitoring committee recommended the use of primary prophylactic G-CSF for patients in the ADCETRIS plus AVD arm of the study due to an increased risk of febrile neutropenia. In the ADCETRIS plus AVD arm, 83 patients received G-CSF primary prophylaxis and 579 patients did not. An analysis of these two patient populations in the ECHELON-1 study presented by Dr. David Straus, Memorial Sloan Kettering Cancer Center, included: The two-year modified PFS rate for patients in the ADCETRIS plus AVD arm who received G-CSF primary prophylaxis was 84.6 percent compared to 81.7 percent for those who did not and compared to 77.2 percent in the ABVD control arm.Use of G-CSF primary prophylaxis in the ADCETRIS plus AVD arm was associated with a decrease in neutropenia , overall febrile neutropenia and febrile neutropenia in the first treatment cycle. Seven of the nine deaths that occurred in the ADCETRIS plus AVD arm were associated with neutropenia, none of whom had received primary prophylaxis with G-CSF before the onset of neutropenia. There was no evidence of an association between use of G-CSF primary prophylaxis and pulmonary toxicity. In the ADCETRIS plus AVD arm, incidence of peripheral neuropathy was 57 percent in patients with G-CSF primary prophylaxis versus 68 percent without. Lastly, use of G-CSF primary prophylaxis was associated with a lower rate of ADCETRIS dose delays and dose reductions compared to those without. A post-hoc analysis of the ECHELON clinical trial was conducted to evaluate modified PFS outcomes and clinical characteristics by PET2 status per IRF. In the ADCETRIS plus AVD arm of the study, 588 patients were PET2-negative and 47 were PET2-positive. In the ABVD arm of the study, 577 patients were PET2-negative and 58 were PET2-positive. The analysis presented by Dr. Robert Chen, City of Hope National Medical Center, included: ADCETRIS plus AVD improved modified PFS outcomes in patients regardless of PET2 status. The modified PFS in PET2-negative patients in the ADCETRIS plus AVD arm was 85.2 percent compared to 80.9 percent in the ABVD arm. The modified PFS in PET2-positive patients in the ADCETRIS plus AVD arm was 57.5 percent compared to 42.0 percent in the ABVD arm. PET2-positive patients in the ADCETRIS plus AVD arm had superior results compared to historical controls. The safety profile of ADCETRIS plus AVD in the ECHELON-1 trial was generally consistent with that known for the single-agent components of the regimen. There were no notable differences in the safety profile between PET2-positive or PET2-negative subgroups in either arm of the study.

09:09 EDT Attis Industries enters partnership with New Representative Group - Attis Industries announced that it has entered into a partnership with a large healthcare sales representative network with connections in multiple states across the United States. The addition of the Rep Group will bolster the company's expanding healthcare business, which already includes the management of rural hospital laboratories and a program to enhance emergency room revenue for community hospitals. The Attis Healthcare business also works with long-term care facilities to implement molecular diagnostic testing to assist those facilities in meeting antibiotic stewardship mandates from the U.S. government, and the company collaborates with businesses to assist in driving down pharmacy and healthcare costs via pharmacogenetic testing and medication management.

09:06 EDT Delta Air Lines reports May traffic up 2.9%, capacity up 3.5% - Load factor for May was up 86.3%. The company carried 16.8 million passengers across its global network, a record for the month of May.

09:05 EDT Qualys announces non-binding letter of intent to acquire Second Front Systems - Qualys announced that it has entered into a non-binding letter of intent to purchase Second Front Systems. When completed, the acquisition would be expected to provide increased domain expertise in building and delivering cybersecurity solutions tailored for the U.S. federal government, including defense, intelligence, and law enforcement. The terms of the letter of intent providing for the proposed acquisition are non-binding and the parties will need to negotiate and enter into definitive agreements before proceeding with the proposed acquisition. If the parties are able to negotiate and enter into such agreements, it is anticipated that the proposed acquisition would be subject to regulatory approvals, as well as other closing conditions. Subject to satisfaction of all conditions and the closing of the proposed acquisition, Qualys would expect Second Front Systems to operate under its federal division as an independent subsidiary. If the parties are able to enter into and consummate the acquisition, Qualys would expect the transaction to close either in Q3 or Q4 of this year.

09:03 EDT Winnebago acquires Chris-Craft From Stellican, terms not disclosed - Winnebago Industries announced that it has acquired Chris-Craft, an iconic recreational boat builder, from Stellican Ltd., which has owned Chris-Craft since 2001. Terms of the transaction were not disclosed. Chris-Craft is expected to be immediately accretive to Winnebago's Fiscal 2019 EPS. Stephen Heese will continue to lead the Chris-Craft business as its President. Winnebago expects to maintain Chris-Craft's Sarasota, Florida headquarters. Chris-Craft will operate as a distinct business unit within a new "Other" operating segment.

09:01 EDT Microsoft to acquire GitHub for $7.5B

08:59 EDT Boeing, Safran agree to design, build and service auxiliary power units - Boeing and Safran have agreed to jointly design, build and service Auxiliary Power Units, creating better value for customers and for both companies. An APU is an onboard engine that is used to primarily start the main engines and power aircraft systems on the ground and, if necessary, in flight. The agreement will establish an important relationship between two of the world's leading aerospace companies to work together on products and expanded service capabilities to benefit both customers and the industry at large. Both companies will have a 50% stake in the partnership, which will be based in the United States. The completion of the transaction is subject to customary conditions including regulatory and antitrust clearance. The deal is expected to close in the second-half of 2018.

08:56 EDT On The Fly: Pre-market Movers - MOVING AFTER ASCO MEETING: Loxo Oncology (LOXO), up 13% after being called the "star" of the American Society of Clinical Oncology meeting by Citi analyst Yigal Nochomovitz after the company announced interim clinical data from the LOXO-292 global Phase 1 LIBRETTO-001 dose escalation trial... Genomic Health (GHDX), up 26% after reporting that the TAILORx study provided definitive evidence that the Oncotype DX Breast Recurrence Score test identified 70% of early-stage breast cancer patients who receive no benefit from chemotherapy and can be effectively treated with endocrine therapy alone... Merck (MRK), up 2% after announcing long-term efficacy data from the Phase 3 KEYNOTE-006 study and the melanoma cohort of the Phase 1b KEYNOTE-001 study at ASCO... Nektar (NKTR), down 31% after providing "immature response rate data" that JPMorgan analyst Jessica Fye says came in on the low end of Street expectations... Jounce Therapeutics (JNCE), down 19% after JPMorgan analyst Cory Kasimov downgraded the stock to Neutral and cut his price target for the shares to $12 from $28 following ASCO data he views as disappointing... Bluebird Bio (BLUE), down 1% after announcing updated results on bb2121, an investigational anti-B-cell maturation antigen AR T cell therapy. ALSO HIGHER: Whirlpool (WHR), up 3% after the stock was upgraded to Outperform from Neutral at Credit Suisse. ALSO LOWER: Colfax (CFX), down 10% after the stock was downgraded to Underperform from Buy at BofA Merrill Lynch.

08:51 EDT Portola Pharmaceuticals reports ORR of 47% in Phase 2a cerdulatinib study - Portola Pharmaceuticals announced new interim results from the company's ongoing Phase 2a study of cerdulatinib, an investigational, oral SYK/JAK inhibitor, in patients with specific subtypes of B-cell and T-cell Non-Hodgkin Lymphoma, including relapsed/refractory follicular lymphoma and peripheral T-cell lymphoma, and chronic lymphocytic lymphoma/small lymphocytic lymphoma. The data will be presented today by Paul Hamlin, M.D., medical director for the David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, during a Poster Discussion Session at the 2018 American Society of Clinical Oncology Annual Meeting in Chicago (June 1-5). Data from this ongoing study also will be presented during a Poster Presentation Session at the 23rd Congress of the European Hematology Association in Stockholm. Among the 114 patients enrolled across five cohorts, 101 were evaluable as of May 4, 2018. The objective response rate across all tumor types was 47 percent, with demonstration of clinical activity across tumor types and a new signal in the PTCL and cutaneous T-cell lymphoma cohorts. Seven of the 20 patients in the PTCL cohort achieved a complete response, including:Five out of seven with angioimmunoblastic T-cell lymphoma, for an ORR of 71 percent. Two out of eight patients with PTCL not otherwise specified, for an ORR of 25 percent. Five of the seven responding PTCL patients remain on study drug, including one at 12+ months and one at 9+ months. Of the remaining two patients, one received a bone marrow transplant after achieving CR and one discontinued due to Grade 3 colitis. All patients were previously on at least three prior therapies, including belinostat, pralatrexate and romidepsin. Additionally, data demonstrate an initial signal in CTCL, with the first patient enrolled achieving a CR.Cerdulatinib also showed consistent activity among the 35 patients with FL, with an ORR of 46 percent and a median duration of response of eight months or more. Among the 28 patients with CLL/SLL, the ORR was 61 percent. All patients in these cohorts were previously on at least three prior therapies.

08:48 EDT Cesca Therapeutics announces reduction in operating expenses - Cesca Therapeutics announced that it is reducing its U.S. and India workforce by approximately 25%, to a total of 60 full-time equivalent employees, under a plan to be substantially completed by the end of June. This reduction is designed to lower operating expenses while the Company focuses on driving growth of revenue-generating products, while at the same time continuing to develop and commercialize the CAR-TXpress cellular processing platform and related X-Series products. Affected employees are being offered severance.

08:43 EDT ConocoPhillips completes bolt-on transaction in Alaska - ConocoPhillips (COP) announced that approvals have been obtained for the previously announced bolt-on acquisition of Anadarko Petroleum Corporation's (APC) 22% lease interests in the Western North Slope of Alaska. ConocoPhillips now has 100% interest in approximately 1.2M acres of exploration and development lands, including the Willow discovery. Approval of the assignment of the lease interests was finalized on May 30, 2018. The previously announced price of $400M before customary adjustments was paid in 1Q18. The expenditure, net of customary adjustments, will be reported as capital in 2Q18. In 1Q18, production associated with the acquired 22% lease interests was 11 thousand barrels of oil equivalent per day. The expected impact on Q2 production is 5 MBOED based on a May 17, 2018 start date. This production was not included in prior guidance.

08:38 EDT SG Blocks signs master services agreement with Grimshaw Architects - SG Blocks has signed a master services agreement with Grimshaw Architects. Under the terms of the agreement, SG Blocks will incorporate Grimshaw as its premier design partner for utilization across its current projects and pipeline of future opportunities. In return, this partnership will allow Grimshaw to incorporate SG Blocks' container-based structures into its global and industrial design portfolio. SG Blocks and Grimshaw will work together to utilize this disruptive building technology across a range of building typologies to deliver meaningful design solutions that bring value and joy to clients and users alike.

08:38 EDT Daxor initiates study with Virginia Commonwealth University - Daxor announces the initiation of an investigator-initiated trial at Virginia Commonwealth University Medical Center that will incorporate the company's patented BVA-100 diagnostic to assess blood volume loss during burn surgery.

08:36 EDT Gladstone Investment exits investment in Drew Foam - Gladstone Investment announced the sale of its equity interest and the prepayment of its debt investments in Drew Foam Companies to a private equity firm. As a result of this transaction, Gladstone Investment realized a significant gain on its equity investment. Drew Foam, headquartered in Monticello, AR, is a market leading designer, molder and fabricator of expanded polystyrene foam products used in industrial, construction, cold chain pharmaceutical and food applications and consumer markets.

08:36 EDT Viveve announces settlement of patent infringement litigation with Thermi - Viveve Medical announced that is has reached a settlement to resolve the patent litigation that it filed in 2016 against ThermiGen, LLC, ThermiAesthetics, LLC, and Dr. Red Alinsod in the U.S. District Court for the Eastern District of Texas citing infringement of Viveve's intellectual property (Viveve, Inc. v. ThermiGen, LLC, No.2:16-1189). Under the settlement, Viveve will receive a monetary payment and on-going royalty, as well as other mutual agreements relating to certain intellectual property owned by the companies.

08:34 EDT AvalonBay sees Q2 total rental revenue for Established Communities up 2.4%-2.5% - AVALONBAY announced that it expects total rental revenue for Established Communities for the three months ending June 30, 2018 to increase between 2.4% and 2.5% over the prior year period. The midpoint of this range is approximately 15 basis-points above what the company's expectation for second quarter performance was when the company published its outlook for full year Established Communities total rental revenue growth on January 31, 2018. The Company further announced that, during the quarter to date, it sold two wholly-owned operating communities for an aggregate sale price of approximately $195M, has two additional wholly-owned communities under contract or in advanced marketing for an expected aggregate sale price of approximately $280M and started construction on two new communities for an expected aggregate Total Capital Cost of approximately $205M.

08:32 EDT Highpower Int'l reports going private proposal from CEO at $4.80 per share - Highpower International announced that its Board of Directors received a non-binding proposal from Dang Yu "George" Pan, the company's Chairman and CEO, to acquire certain outstanding shares of common stock of the company at a cash purchase price of $4.80 per share. In the proposed potential transaction, Pan would acquire all of the outstanding shares of common stock of the company not currently owned by him through a merger of the Company with a newly formed acquisition vehicle that Pan would control. The Board intends to form a special committee consisting of independent directors to consider this proposal. Pan's proposal letter states that he intends to finance the proposed transaction with debt or equity capital. Furthermore, the proposal letter specifies that Pan's proposal constitutes only a preliminary indication of interest, and is subject to negotiation and execution of definitive agreements relating to the proposed transaction.

08:28 EDT Kimco Realty adds to anchor lineup at Mill Station Signature Series development - Kimco Realty Corp. (KIM) announced that Lowe's Home Improvement (LOW), Marshalls, TJX's (TJX) new HomeSense concept, Burlington (BURL) and Five Below (FIVE) will join the tenant lineup at Mill Station, the company's $108M Signature Series development on the site of the former Owings Mills Mall in Baltimore County, Maryland. With these newly announced retailers, in addition to Costco (COST)and AMC Theatre (AMC), the project is now over 75% preleased, and construction has commenced. Costco is on track to open later this year, with the remainder of the announced retailers anticipated to open throughout the first half of 2019. The approximately 620,000-square-foot Mill Station development will feature up to 30 retailers and restaurants in a modern, open layout with green space and a network of walkways connecting to existing office and retail space. Situated directly off I-795 and adjacent to the Owings Mills Station stop on Baltimore's Metro SubwayLink, the shopping center will serve a population of 167,000 in the surrounding five-mile area, with an average household income of approximately $95,000.

08:25 EDT Highpower International trading halted, news pending

08:15 EDT Sangamo: MHRA of UK grants CTA for trials evaluating SB-318,SB-913 - Sangamo Therapeutics announced that the Medicines and Healthcare Products Regulatory Agency of the United Kingdom has granted the Clinical Trial Authorisation for enrollment of subjects into ongoing Phase 1/2 clinical trials evaluating SB-318 and SB-913, zinc finger nuclease in vivo genome editing treatments for Mucopolysaccharidosis Type I and MPS II, respectively. Sangamo expects to initiate clinical trial sites in the U.K. later this year for the SB-318 and SB-913 Phase 1/2 clinical trials.

08:12 EDT Merck KGaA, Pfizer provide update on JAVELIN Merkel 200 trial of BAVENCIO - Merck KGaA (MKGAY) and Pfizer (PFE) announced that updated efficacy and safety data from the pivotal JAVELIN Merkel 200 trial of BAVENCIO in patients with metastatic Merkel cell carcinoma will be presented as an oral abstract session at the 54th American Society of Clinical Oncology Annual Meeting on Monday, June 4 from 10:12-10:24 a.m. CDT in Chicago, IL. At this two year follow-up update of the pivotal study, BAVENCIO continues to demonstrate clinically meaningful durable responses and stable rates of progression-free survival and overall survival from previous analyses in patients who responded to this treatment. Clinical activity was observed across all patient subgroups, irrespective of PD-L1 expression in tumor tissue or Merkel cell polyomavirus status. The safety profile for BAVENCIO in this trial has not changed with longer follow-up and remains consistent with that observed in the overall JAVELIN clinical development program.

08:10 EDT Calithera to present results from Phase 1 CB-839 combination study at ASCO - Calithera Biosciences announced that clinical data from its lead product candidate CB-839, a novel glutaminase inhibitor, will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology, which is being held from June 1 to June 5, 2018 in Chicago, Illinois. This is the first presentation of the Case Western investigator-sponsored phase 1/2 trial evaluating CB-839 in combination with capecitabine in patients with treatment refractory advanced solid tumors. The combination demonstrated a median progression free survival of 26 weeks in seven patients with treatment-refractory advanced colorectal cancer harboring a PIKC3A mutation who had disease progression on at least one prior fluoropyrimidine-containing regimen. The data will be presented on Monday June 4, 2018 in the Developmental Therapeutics Poster Session from 8:00 a.m.-11:30 a.m. CT. Dr. Jennifer Eads from Case Comprehensive Cancer Center will present the results in a poster entitled, "Phase 1 clinical trial of the glutaminase inhibitor CB-839 plus capecitabine in patients with advanced solid tumors." The phase 1 portion of the trial is designed to determine safety and the recommended dose of the combination of CB-839 and capecitabine in patients with advanced treatment refractory solid tumors, while the phase 2 portion of the trial is designed to evaluate activity of the regimen in patients with late line PIK3CA mutant colorectal cancer. To date, 16 patients have been enrolled, including 12 patients with colorectal cancer. In the dose escalation phase of the trial, there were no dose limiting toxicities and CB-839 plus capecitabine was well tolerated at full dose of CB-839. The recommended phase 2 dose for the combination is CB-839 800 mg BID with capecitabine 1000 mg/m2 BID. In patients with late-line colorectal cancer that had progressed on at least one prior fluoropyrimidine-containing regimen, the median PFS was 26 weeks for patients with PIK3CA mutated cancer and 16 weeks for patients with PIK3CA wild-type cancer. The phase 2 portion of this study in patients with PIK3CA mutant colorectal cancer is ongoing.

08:10 EDT Immunomedics to present business update at ASCO - Immunomedics announced a comprehensive overview of its clinical development plan for sacituzumab govitecan, Immunomedics' lead ADC, at the company's Investor Event during the 2018 ASCO Annual Meeting. The plan focuses on three cancer indications with significant unmet need: metastatic triple-negative breast cancer, or mTNBC, metastatic urothelial cancer, or mUC, and estrogen receptor-positive metastatic breast cancer, or ER+ mBC. "Our goal is to bring sacituzumab govitecan to patients who can benefit from this valuable drug candidate, expeditiously. Beyond TNBC, for which we recently announced our BLA submission, we are working closely with health authorities and key opinion leaders to define the best registrational approaches for additional indications that could benefit patients," said Michael Pehl, President and CEO of Immunomedics.

08:09 EDT 3M completes sale of substantially all of its Communication Markets Division - 3M (MMM) announced that it has completed the sale of substantially all of its Communication Markets Division to Corning Incorporated (GLW), for approximately $870M, before closing and other adjustments. The business includes 3M's optical and copper passive connectivity solutions for the telecommunications industry, including 3M's xDSL, FTTx, and structured cabling solutions. The sale of the telecommunications system integration services portion of the business based in Hannover, Germany, remains pending and is expected to be completed by the end of 2018 for approximately $30M. Total annual global sales of the business are approximately $400M. 3M expects to realize a full-year 2018 earnings benefit of 40c to 45c per share from this transaction, net of actions related to the divestiture.

08:09 EDT Versartis enters into merger agreement with Aravive Biologics - Versartis and Aravive Biologics jointly announced that they have entered into a definitive agreement under which Aravive will merge with a wholly owned subsidiary of Versartis in an all-stock transaction. The transaction will result in a clinical stage, Nadsaq-listed company, based in Houston, Texas, focused on the development of innovative oncology therapeutics. Aravive Biologics is a privately held clinical stage biopharmaceutical company developing novel, highly selective therapies designed to treat serious cancers and certain fibrotic diseases. Aravive's lead program is focused on inhibition of the GAS6-AXL signaling axis, which is a known target associated with the growth and proliferation of multiple tumor types. In preclinical studies, GAS6-AXL inhibition has shown activity, whether achieved by a single agent or in combination with a variety of anticancer therapies including radiation therapy, immuno-oncology agents, and drugs that affect DNA replication and repair. Clinically, elevated GAS6 levels have been associated with poor prognosis in cancer. Aravive has established clinical proof-of mechanism for its first-in-class drug candidate, demonstrating full GAS6 neutralization with AVB-S6-500, and plans to initiate an expanded clinical development program combining it with standard of care therapies in patients with a number of tumor types, initially in ovarian cancers in the second half of 2018.

08:07 EDT Masonite completes acquisition of AADG - Masonite announced that it has completed the acquisition of the operating assets of the wood door companies of AADG, which includes the brands Graham Manufacturing and Maiman. Graham provides the non-residential construction industry with a full range of architectural premium and custom grade flush wood doors. Maiman is a manufacturer of architectural stile and rail wood doors, thermal fused flush wood doors and wood door frames. The two divisions employ approximately 275 people located in their three manufacturing facilities in Mason City, IA and Springfield, MO. Net sales for the two divisions for the twelve months ended December 2017 were approximately $70M.

08:06 EDT MEI Pharma presents data for ME-344 at ASCO - MEI Pharma announced that data presented at ASCO 2018 from an investigator-initiated study of ME-344 in patients with HER2 negative breast cancer demonstrate evidence of inhibition of tumor proliferation as measured by Ki-67 reductions. These interim data are consistent with preclinical results indicating ME-344's potential to reverse resistance to anti-angiogenic therapy, thereby warranting the continuation of the ongoing study.

08:04 EDT Fat Brands announces agreement to open five restaurants in Bali, Jakarta - Fat Brands announced the company has signed a new development international agreement with existing partner PT Global Food Indonesia. Under the new deal, PT Global Food Indonesia will open at least five co-branded Fatburger and Buffalo's Express restaurants in Bali and Jakarta. Committed to international expansion, Fatburger and Buffalo's Express continue to bring their all-American dining experiences to new and familiar territories worldwide. To date, the burger and chicken brands have over 200 locations open or under construction in 32 different countries with recent openings in Southern California, Japan and Canada.

08:04 EDT Apollo Endosurgery announces presentation of instragastric balloon comparison - Apollo Endosurgery announced Digestive Disease Week presentation of a meta analysis that concluded fluid-filled balloons, like the ORBERA Intragastric Balloon, have superior weight loss results to gas-filled balloons. This meta-analysis reviewed twenty-one randomized clinical trials with 877 patients, including trials for all three FDA-approved intragastric balloons and assessed weight loss metrics at 6 and 12 months. The study was led by physicians at the Mayo Clinic, Massachusetts General Hospital and Digestive Center for Diagnosis & Treatment.The study showed fluid-filled balloons resulted in 60% more total body weight loss at 6 months compared with gas-filled balloons, with SUCRA probabilities demonstrating superiority of liquid-filled intragastric balloons at all time points. ORBERA had the highest average weight loss of any of the intragastric balloons included in the meta-analysis. The authors attributed the greater weight loss with ORBERA and fluid filled balloons to their impact on the gastric emptying process. The authors theorize that the gas-filled balloons are less effective because of their "inability to significantly delay gastric emptying." The authors also reported that all balloon types are associated with similar adverse events although fluid-filled balloons maybe associated with more symptoms and worse tolerance given their more pronounced impact on gastric emptying.

08:00 EDT Business First Bancshares, Richland State Bancorp to merge - Business First Bancshares and Richland State Bancorp jointly announced the signing of a definitive agreement under which Business First will acquire Richland State and its wholly owned bank subsidiary, Richland State Bank. On a pro forma basis as of March 31, 2018, the combined institution would be the 4th largest Louisiana-headquartered bank, with total assets of approximately $2B. Under the terms of the merger agreement, which has been approved by the board of each company, Richland State's shareholders will receive cash consideration of approximately $10.6 million and 1,679,608 shares in Business First Bancshares stock, subject to certain conditions and potential adjustments set forth in the merger agreement. Based on Business First's closing stock price of $23.92 on June 1, 2018, the transaction is valued at approximately $50.8M in the aggregate. The merger agreement contains customary representations and warranties and covenants by Richland State and Business First, and is subject to customary closing conditions, including approval by Richland State's shareholders and the receipt of customary regulatory approvals. The transaction is expected to close in the fourth quarter of 2018.

07:57 EDT Blackstone, Osprey form combined Falcon Minerals valued at $894M - Osprey Energy announced it has entered into a definitive agreement to acquire the assets of Royal Resources, an entity owned by funds managed by Blackstone. The acquired Royal assets represent the entirety of Blackstone's mineral interests in the Eagle Ford Shale, and the transaction will create a company with a total enterprise value of approximately $894M. The combined company, which will be named Falcon Minerals Corporation, will be led by Osprey's management team. Blackstone will retain a significant ownership stake in Falcon Minerals at closing representing approximately 47% of outstanding common stock. The formation of Falcon Minerals creates a unique, high growth, core-of-the-core oil and gas minerals company with Eagle Ford and Austin Chalk asset positions covering 251,000 gross unit mineral acres. Net production over the first quarter was 4,764 boe per day increasing recently to a rate approaching 7,000 boe per day from new wells coming on line. Net production for 2018 is expected to be approximately 6,352 boe per day. Falcon Minerals is expected to have over 85% of its reserve value in long-lived, undeveloped acreage with over 3,000 locations which generate IRRs to operators in excess of 100%. Falcon Minerals expects to generate cash margins above 90%, and to distribute nearly all of its free cash flow, and currently expects to pay an initial cash dividend after closing of the transactions of 90c per share per year. Currently, there are over 1,789 producing wells on the properties with expected 2018 liquids production of greater than 73%, and over 80% of revenue derived from oil.

07:56 EDT Merck says KEYTRUDA showed 'promising' anti-tumor activity in advanced SCLC - Merck announced interim data from a cohort of the Phase 2 KEYNOTE-158 study evaluating KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy in patients with previously treated advanced small cell lung cancer. Findings showed an overall response rate of 18.7 percent in patients in the SCLC cohort, the primary endpoint of the study. Additionally, in a pre-specified exploratory analysis, ORR was 35.7 percent in patients whose tumors expressed PD-L1 with a combined positive score of greater than or equal to1. These results, as well as other findings from the KEYNOTE-158 cohort in SCLC, are being presented for the first time today at the 2018 American Society of Clinical Oncology Annual Meeting. KEYNOTE-158 is an ongoing global, open-label, non-randomized, multi-cohort, multi-center, Phase 2 study evaluating KEYTRUDA in patients with multiple types of advanced solid tumors - including SCLC - that have progressed on standard of care therapy. The SCLC cohort of the study enrolled 107 patients, regardless of biomarker status, who received KEYTRUDA as monotherapy. The primary endpoint was ORR as evaluated by independent central review using RECIST v1.1. Secondary endpoints are progression-free survival, overall survival, duration of response and safety. In the overall SCLC patient cohort, data at ASCO showed an ORR of 18.7 percent, with a complete response rate of three percent and a partial response rate of 16 percent. Median DOR was not reached and 73 percent of patients had a DOR of 12 months or longer. Median PFS was 2.0 months with six- and 12-month PFS rates of 23.7 percent and 16.8 percent, respectively. Median OS was 8.7 months with six- and 12-month OS rates of 57.5 percent and 40.2 percent, respectively. In the pre-specified, exploratory analyses based on PD-L1 status, patients whose tumors expressed PD-L1 showed an ORR of 35.7 percent, with a complete response rate of five percent and a partial response rate of 31 percent. Additionally, median PFS was 2.1 months with six- and 12-month PFS rates of 38.9 percent and 28.5 percent, respectively. Median OS was 14.9 months with six- and 12-month OS rates of 66.0 percent and 53.1 percent, respectively. In patients whose tumors did not express PD-L1, ORR was six percent, with a complete response rate of two percent and a partial response rate of four percent. Median PFS was 1.9 months with six- and 12-month PFS rates of 14.3 percent and 8.2 percent, respectively. Median OS was 5.9 months with six- and 12-month OS rates of 48.3 percent and 30.7 percent, respectively. In other pre-specified subgroup analyses, the ORR was generally consistent across clinically relevant subgroups, including patients who had received two or more prior lines of therapy where the ORR was 23 percent. The safety profile was consistent with what has been seen in previously reported studies of KEYTRUDA monotherapy in lung cancer. Treatment-related adverse events occurring in 10 percent or more of patients were fatigue, pruritus, hypothyroidism, decreased appetite and nausea. Thirteen patients had grade 3-4 TRAEs; two deaths occurred due to TRAEs. Immune-mediated adverse events and infusion reactions were reported in some patients. Hypothyroidism was the most commonly reported immune-mediated adverse event, followed by hyperthyroidism and severe skin reactions.

07:51 EDT Hill International selected as Independent Engineer for airport project in Crete - Hill International announced it was selected as the Independent Engineer for the New International Airport of Heraklion project on the Island of Crete. The total investment is expected to exceed $585M. Following an international open tender, in May 2017 the Hellenic Republic announced the Consortium Ariadne Airport Group as the Provisional Contractor for the design, construction, financing, operation, and exploitation of the airport project and the construction/financing of the associated road connections. Ariadne Airport Group comprises reputable Greek corporation TERNA S.A. and GMR Airports Ltd, an India-based company. The project will be developed under a Concession Agreement for a period of 35 years, with the Hellenic Republic maintaining a 45.9% stake in the concession.

07:46 EDT Reata Pharmaceuticals announces initiation of bardoxolone methyl Phase 3 trial - Reata Pharmaceuticals announced that its licensee, Kyowa Hakko Kirin, has initiated a Phase 3 clinical study, AYAME, to assess the efficacy and safety of bardoxolone methyl for the treatment of diabetic kidney disease in Japan. In late 2017, Kyowa Hakko Kirin presented results from the Phase 2 TSUBAKI trial demonstrating that bardoxolone treatment led to statistically significant and clinically meaningful increases in directly-measured glomerular filtration rate, or GFR, in patients with type 2 diabetes and chronic kidney disease, or CKD, using the "gold standard" inulin clearance method. By excluding patients at risk of fluid retention and monitoring patients carefully, bardoxolone was well tolerated. There was no adverse effect on blood pressure and no evidence of overt fluid overload or cardiac toxicity. Based on this and other data, Kyowa Hakko Kirin received SAKIGAKE Designation for bardoxolone for the treatment of diabetic kidney disease by the Japanese Ministry of Health, Labour and Welfare in March 2018.

07:44 EDT Miragen Therapeutics to present cobomarsen phase 1 trial data at ASCO - miRagen Therapeutics announced the first observations on the safety and efficacy of cobomarsen in adult T-cell leukemia/lymphoma, or ATLL, patients, a highly morbid T-cell malignancy seen in patients previously infected with the human T-lymphotropic virus type 1, or HTLV1. The company also released new interim data from its ongoing Phase 1 clinical trial of cobomarsen, a microRNA-155 inhibitor, in patients with the mycosis fungoides, or MF, form of cutaneous T-cell lymphoma, or CTCL. These data will be presented today, June 4, at the 2018 American Society of Clinical Oncology, or ASCO, Annual Meeting being held in Chicago, IL. "We are excited to release the first safety and efficacy observations after cobomarsen dosing in ATLL patients as well as new data from MF patients that continue dosing in the Phase 1 study." said miRagen President and CEO William S. Marshall, Ph.D. "We believe these new data from the trial are compelling and support the continued investigation of cobomarsen in the MF population and other hematological malignancies. We remain on track to initiate the Phase 2 clinical trial of cobomarsen in patients with MF in the second half of 2018. Based on FDA feedback, we believe this Phase 2 clinical trial, if positive, has the potential to be registrational."

07:41 EDT Icahn urges SandRidge shareholders to elect slate of director nominees - Carl Icahn released an open letter to stockholders of SandRidge Energy, which states in part: "We are the largest stockholder of SandRidge Energy, Inc., with a position of 4.8 million shares constituting 13.6% of the company's outstanding stock. We recently filed our definitive proxy statement with the Securities and Exchange Commission regarding our campaign to replace the entire board of directors of SandRidge at the upcoming 2018 annual meeting of stockholders. We believe this drastic measure is warranted because, since emerging from bankruptcy, the board has exhibited a clear and consistent pattern of failure. Time and again the board has failed to understand and address the concerns of stockholders and has only acted when threatened with legal process or open stockholder revolt. And yet, remarkably, they still seem not to have gotten the message... The owners of SandRidge must act NOW to take back control of their company. The choice is yours. You can vote for the incumbent directors on management's slate, who we believe have already proved they are acting in the grand tradition of the previous managements and boards of SandRidge - that is, disregarding the interests of stockholders at every turn - or you can VOTE FOR CHANGE by electing our slate of highly-qualified nominees. The incumbent directors are reminiscent of Keystone Cops with one discernible skill: they have proven to be quite adept at delivering extravagant stockholder-funded gifts to bankers and lawyers for advising on failed deals and concocting devilish schemes to disenfranchise the company's owners and to former executives for driving SandRidge into bankruptcy and erasing billions of dollars in equity value. we believe these directors can and should be called to task for countenancing such highly questionable payments. We, on the other hand, have created hundreds of billions of dollars of value for stockholders over the last 30 years by convincing boards and CEOs to take the steps necessary to greatly increase the value of their companies. Several well-known examples include Texaco, RJR Nabisco, Kerr-McGee, Time Warner, Motorola, ImClone, eBay, Forest Labs and National Energy Group, as well as many others. Unfortunately, it often took years for management and the boards of those companies to agree that we were correct. However, the current situation at SandRidge is too time-sensitive to wait years, especially when every single stockholder with whom we have spoken believes management's current plan (or lack thereof) is insufficient."

07:39 EDT Infinity Pharmaceuticals reports IPI-549 clinical, translational data at ASCO - Infinity Pharmaceuticals announced that data to be presented today at the ASCO 2018 Annual Meeting demonstrates that IPI-549, a first-in-class immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase gamma, in combination with nivolumab was well tolerated and demonstrated evidence of clinical activity in indications not typically responsive to anti-PD1 therapy 40% (12 of 30) of evaluable patients demonstrated disease control with 10 patients with stable disease and two patients who achieved rapid, deep and durable partial responses, including one patient with adrenocortical cancer and one with microsatellite stable gallbladder cancer. In addition, IPI-549 reduced immune suppression and induced immune activation, as indicated by analyses of peripheral blood and paired tumor biopsies. "We were encouraged to see rapid, deep and durable responses in some patients with the combination of IPI-549 and nivolumab in dose escalation, and we look forward to continuing to evaluate this combination in specific patient populations through the seven combination expansion cohorts," said Dr. Ryan J. Sullivan, Massachusetts General Hospital, and an investigator on the IPI-549 Phase 1/1b study. "There remains a critical unmet need for patients with a number of solid tumors who do not benefit from anti-PD1 therapy, and IPI-549 in combination with nivolumab may offer an important therapeutic alternative." IPI-549 combined with nivolumab in dose escalation was well tolerated at all doses tested, up to the recommended expansion dose of IPI-549 at 40mg once daily plus nivolumab at 240mg once every two weeks. No maximum tolerated dose was determined, and there were no treatment-related deaths. Additionally, the pharmacokinetic/pharmacodynamic profile of IPI-549 (up to 40mg QD) was unaffected by nivolumab co-administration. IPI-549 as a monotherapy also continued to be well tolerated at all doses studied up to the recommended dose for expansion of 60 mg once daily. IPI-549 demonstrated evidence of monotherapy clinical activity, with one durable partial response in peritoneal mesothelioma, where a patient remains on study after 20 months.

07:35 EDT Idera Pharmaceuticals presents data from ILLUMINATE-204 trial at ASCO - Idera Pharmaceuticals announced results from the ongoing ILLUMINATE-204 trial investigating tilsotolimod, Idera's intratumorally-delivered Toll-like Receptor, or TLR, 9 agonist, in combination with ipilimumab. Current data show an overall response rate, or ORR, of 38 percent following treatment with the combination of tilsotolimod and ipilimumab. This includes 2 complete responses and an ongoing PR for 12 months. These results will be presented at the 2018 American Society of Clinical Oncology, or ASCO, Annual Meeting in Chicago, IL during the poster display session from 1:15-4:45 PM CT and as the subject of a poster discussion session from 4:45-6:00 PM CT. "We have clinical evidence that tilsotolimod activates both the innate and adaptive immune responses, and when used in combination with a checkpoint inhibitor like ipilimumab, triggers immune responses in previously resistant tumors," stated Adi Diab, M.D., Lead Trial Investigator, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas, MD Anderson Cancer Center. "In patients with metastatic melanoma receiving pembrolizumab who switched to single agent ipilimumab at the time of disease progression the reported ORR was 13%. The ORR of 38% observed in the ILLUMINATE-204 study and the duration of response, which is ongoing in most of the responders, is particularly encouraging and suggests that the combination of tilsotolimod and ipilimumab is a very promising strategy for treating patients with metastatic melanoma whose cancer does not respond to PD-1 therapy alone."

07:33 EDT Adaptimmune presents detailed safety update from MAGE-A10 studies at ASCO - Adaptimmune Therapeutics presented a safety update from its two ongoing pilot studies with SPEAR T-cells targeting MAGE-A10 in non-small cell lung cancer, or NSCLC, and the triple tumor study in bladder, melanoma, and head & neck cancers at the American Society of Clinical Oncology, or ASCO, annual meeting.

07:32 EDT Novocure to present INNOVATE-3 Phase 3 pivotal trial design - Novocure will present the design of its phase 3 pivotal trial of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer at the American Society of Clinical Oncology Annual Meeting 2018 in Chicago. 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. INNOVATE-3, a prospective, open-label study, will include 540 patients with recurrent, platinum-resistant ovarian cancer. Patients will be randomized to receive either weekly paclitaxel alone or weekly paclitaxel in combination with Tumor Treating Fields tuned to 200 kHz until progression. The primary endpoint is overall survival. Secondary endpoints include progression free survival, objective response rate, severity and frequency of adverse events, time to undisputable deterioration in health-related quality of life or death, and quality of life. Patients must be 18 years or older, and have an epithelial histology of ovarian/primary peritoneal or fallopian tube carcinoma at diagnosis, an Eastern Cooperative Oncology Group score of 0-1, and evaluable disease in the abdominal/pelvic region. Patients may have had a maximum of two prior lines of systemic therapy following diagnosis of platinum-resistance. Patients who have participated in prior clinical trials may be included. The trial design for INNOVATE-3 was based on the promising results of Novocure's phase 2 pilot trial in recurrent ovarian cancer, which examined Tumor Treating Fields in combination with standard of care chemotherapy. This trial was a single-arm, open-label, historically-controlled, multi-center study, designed to test the feasibility, safety and preliminary efficacy of Tumor Treating Fields in combination with weekly paclitaxel. The paclitaxel control arm from the bevacizumab phase 3 FDA registration trial was used as a historical control in this trial. A total of 30 patients were enrolled with a minimum follow-up of six months. Safety results suggested that Tumor Treating Fields in combination with weekly paclitaxel may be tolerable and safe as first-line treatment for patients with recurrent ovarian cancer. Median progression free survival in the Tumor Treating Fields-treated group was 8.9 months and median overall survival was not yet reached. Median one-year survival was 61 percent. Efficacy results based on the 30 evaluable patients suggested more than doubling of the progression free survival and an improvement in overall survival among patients who received Tumor Treating Fields therapy with paclitaxel compared to paclitaxel alone.

07:30 EDT Dova Pharmaceuticals announces publication of Doptelet Phase 3 data - Dova Pharmaceuticals announced the recent online publication of its pivotal Phase 3 trial data on the use of Doptelet for the treatment of thrombocytopenia in patients with chronic liver disease, or CLD, in the journal Gastroenterology; the final printed article, entitled "Avatrombopag before Procedures in Patients with Chronic Liver Disease and Thrombocytopenia: 2 Phase 3 Studies," is to be published in the next four to six weeks. In addition, the Company is today announcing multiple presentations for DOPTELET at several key global scientific congresses in June and July of this year. Doptelet is a second generation, once daily, orally administered TPO receptor agonist that was approved by the FDA on May 21, 2018 for the treatment of thrombocytopenia in adult patients with CLD who are scheduled to undergo a procedure.

07:18 EDT Amag Pharmaceuticals announces FDA acceptance of NDA filing - AMAG Pharmaceuticals announced that the FDA has accepted its New Drug Application, or NDA, for bremelanotide, a first-in-class melanocortin 4 receptor agonist designed for the treatment of hypoactive sexual desire disorder, or HSDD, in premenopausal women. The Prescription Drug User Fee Act, or PDUFA, date for completion of FDA review of the bremelanotide NDA is March 23, 2019. HSDD is the most common type of female sexual dysfunction, affecting approximately six million premenopausal women in the U.S. HSDD is characterized by persistent low sexual desire that is associated with distress, often negatively impacting women's emotional health, intimate relationships, and overall quality of life.

07:15 EDT Verastem announces inducement grants for 405,000 shares - Verastem announced the grant of stock options to fourteen new employees to purchase an aggregate of 405,000 shares of Verastem Oncology's common stock. The options were granted as an inducement material to the employees' acceptance of employment with Verastem Oncology in accordance with Nasdaq Listing Rule 5635. The options have an exercise price equal to $5.33, the closing price of Verastem Oncology's common stock as reported by Nasdaq on June 1. One-fourth of the shares underlying each employee's option will vest on the one-year anniversary of his or her date of hire, and thereafter, an additional 6.25% of the shares subject to the options will vest at the end of each successive three-month period, provided that the employee continues to serve as an employee of or other service provider to Verastem Oncology on each such vesting date.

07:14 EDT Acasti Pharma appoints Brian Groch as Chief Commercial Officer - Acasti Pharma announced the appointment of Brian Groch as Chief Commercial Officer. Groch served as Executive Vice President and Chief Commercial Officer at Veru.

07:12 EDT Alnylam announces orphan drug designation for ALN-TTRsc02 - Alnylam announced that the FDA has granted orphan drug designation to ALN-TTRsc02, an investigational RNAi therapeutic for the treatment of transthyretin-mediated amyloidosis. ALN-TTRsc02 has the potential to be a once-quarterly, low volume, subcutaneously administered RNAi medication in the management of this serious disease. The European Commission also recently issued the decision to adopt the opinion of the European Medicines Agency, or EMA, Committee for Orphan Medicinal Products, or COMP, and designate ALN-TTRsc02 as an orphan medicinal product in the European Union for the treatment of transthyretin-mediated amyloidosis.

07:12 EDT Acceleron announces updated results from ongoing trials of luspatercept - Acceleron Pharma announced updated results from the Phase 2 trials of luspatercept in patients with lower-risk myelodysplastic syndromes at the American Society of Clinical Oncology 2018 Annual Meeting in Chicago. Luspatercept is being developed as part of a global collaboration between Acceleron and Celgene. Patients with MDS suffer from insufficient production of red blood cells, resulting in chronic anemia that can lead to debilitating fatigue, diminished quality of life and increased mortality. Because MDS-related chronic anemia often fails to respond to unapproved therapies which include erythropoiesis-stimulating agents, many patients require frequent red blood cell transfusions. A total of 101 patients with lower-risk MDS have been treated with luspatercept in the Phase 2 trials. 55% achieved a clinically meaningful erythroid improvement. 44% with a red blood cell transfusion burden at baseline achieved RBC transfusion independence for at least 8 weeks. The mean duration of treatment for RBC-TI responders was 18.3 months. Multiple patients continue on treatment through 40 months, and continue to sustain a clinically meaningful increase in hemoglobin and reduction in transfusion burden. The majority of adverse events were Grade 1 or 2. Grade 3 non-serious AEs possibly related to study drug were ascites, blood bilirubin increase, bone pain, hypertension, mucosal inflammation, platelet count increase, and transformation to AML/ The Grade 3 non-serious AEs occurred in one patient each, with the exception of hypertension in 2 patients. Serious AEs possibly related to study drug were general physical health deterioration, muscular weakness, musculoskeletal pain, and myalgia. The four SAEs occurred in three individual patients. Luspatercept is an investigational product that is not approved for any use in any country.

07:09 EDT Sierra Metals announces drilling results from Yauricocha Mine, Peru - Sierra Metals announced drilling results demonstrating high grade polymetallic ore and a new mineralization style of Hydrothermal Breccias located at the Contacto Oriental Zone extension situated within the Central Mine at Yauricocha. To date, four holes have been executed from the 1070 level of the Yauricocha Mine in the Contacto Oriental Area. These holes have intercepted polymetallic sulphide mineralization containing high-grade zinc and copper zones over significant widths. These results demonstrate the potential for high grade mineralization within the reported area, and more importantly indicate the continued existence of extensive mineralization at depth. These results come as part of an ongoing brownfield drilling program testing priority targets at the Yauricocha Mine, which is located 150 kilometers east-southeast of Lima in the Yauricocha Mining District, Peru.

07:08 EDT Synlogic announces new preclinical data from SYNB1020 at DDW - Synlogic announced that new preclinical data from SYNB1020, a Synthetic Biotic medicine currently being evaluated in an ongoing Phase 1b/2a clinical trial in patients with cirrhosis and elevated ammonia, were presented at Digestive Disease Week, or DDW, 2018. The new preclinical data demonstrate that, in addition to lowering systemic levels of ammonia, administration of SYNB1020 resulted in reduced indicators of liver damage, including liver enzymes and inflammatory markers, fibrosis and gut permeability, providing additional support for the continued development of SYNB1020 as a potential treatment for liver disease. SYNB1020 is a strain of a probiotic bacterium, E.coli Nissle, that has been engineered to convert ammonia into arginine, a beneficial amino acid, making it a potential treatment for diseases, such as cirrhosis, where elevated ammonia is a result of the disease. A phase 1 clinical trial in healthy human volunteers demonstrated SYNB1020 was well-tolerated and provided evidence supporting proof of mechanism. In preclinical animal models of hyperammonemia, orally administered SYNB1020 has been demonstrated to lower blood ammonia in a dose-dependent manner and improve survival in treated animals fed a high protein diet, a major source of ammonia.

07:07 EDT Vaxart Phase 2 trial of Teslexivir does not achieve primary efficacy endpoint - Vaxart reported the topline results from a Phase 2 clinical trial evaluating the safety and efficacy of an antiviral teslexivir 5% gel dosed topically twice daily in 218 subjects for the treatment of condyloma, or anogenital warts. The primary efficacy endpoint was defined as complete clearance of baseline condyloma by week 16. Analysis of the topline data demonstrated the study met all its primary safety objectives, with teslexivir showing a benign safety and tolerability profile, comparable to placebo. Adverse events and local skin reactions in the teslexivir group were also comparable with placebo, with mostly mild adverse events in both groups. No serious adverse events were observed. Early treatment termination, which we consider an important marker of product tolerability, was minimal with only 1.4% of patients discontinuing in either group. With respect to the primary efficacy endpoint, 30.6% of patients in the teslexivir group completely cleared baseline condyloma by week 16, compared to 23.3% of patients in the placebo group. The difference was not statistically significant. In preliminary subgroup analysis, the rate of complete baseline condyloma clearance trended higher in female patients and in patients with large condylomas, although results were not significant in either group. A number of patients remain in the 3 month follow-up assessment period of the study. Following the completion of the last patient visit in the follow-up recurrence assessment period and the cleaning and lock of that portion of the study, Vaxart will report on the recurrence efficacy endpoints. This teslexivir trial was a Phase 2 double-blind, randomized, placebo-controlled trial designed to evaluate the safety, tolerability and efficacy of teslexivir 5% gel in male and female patients with condyloma, or anogenital warts. 218 female and male patients with 2-30 external condyloma were randomized in a 2:1 ratio, with randomization stratified on gender, to be dosed twice daily for up to 16 weeks with teslexivir or placebo gel. Condyloma and local skin tolerability were measured and assessed by investigators at study visits occurring 2, 4, 6, 9, 12 and 16 weeks following randomizations and initiation of dosing. If subjects cleared all condyloma prior to the end of 16 weeks, they proceeded directly to the 3-month untreated safety follow-up phase to assess for condyloma recurrence. The primary efficacy endpoint was to determine the complete clearance rate for baseline anogenital warts from the commencement of therapy to the end of the treatment period. Secondary efficacy endpoints include various assessments of clearance, time to clearance, and wart area reduction for both baseline warts and post-baseline emergent warts.

07:05 EDT Becton Dickinson announces collaboration with Helmer for medical refrigerator - Becton Dickinson announced a collaboration to introduce a medical-grade refrigerated solution integrated with an automated dispensing system to provide clinicians secure, single line-item access to high-risk and high-value refrigerated medications. While automated medication dispensing has been an industry norm for decades, there has been a technology gap for the secure, automated dispensing of medications that require refrigeration. Through this exclusive collaboration, BD and Helmer have co-developed a refrigeration and temperature monitoring solution with secure, single line-item access that integrates directly with the BD Pyxis MedStation ES system, expanding BD's enterprise-wide medication management solutions to include temperature-controlled medications.

07:05 EDT Bristol-Myers reports Opdivo plus chemotherapy showed improved PFS in study - Bristol-Myers Squibb announced results from a part of the Phase 3 CheckMate -227 trial that evaluated Opdivo plus low-dose Yervoy and Opdivo plus chemotherapy versus chemotherapy in patients with first-line advanced non-small cell lung cancer with PD-L1 expression less than1%, across squamous and non-squamous tumor histologies. Data show that Opdivo plus chemotherapy (n=177) extended progression-free survival, or PFS, versus chemotherapy in patients with PD-L1 expression less than1%. PFS is a secondary endpoint for Opdivo plus chemotherapy in Part 1b of the study, and results are based on a descriptive analysis. In an exploratory analysis of patients with high tumor mutational burden (TMB) greater than or equal to10 mutations/megabase and PD-L1 expression less than1%, the one-year PFS rates were 45% with Opdivo plus low-dose Yervoy, 27% with Opdivo plus chemotherapy and 8% with chemotherapy. In patients with low TMB and PD-L1 less than1%, the one-year PFS rate was 18% with both Opdivo plus low-dose Yervoy and Opdivo plus chemotherapy and was 16% with chemotherapy. Hossein Borghaei, D.O., study investigator and chief of thoracic medical oncology at Fox Chase Cancer Center in Philadelphia, said, "For the first time, CheckMate -227 allows the oncology community to look at I-O/I-O and I-O/chemotherapy in one data set. Results show Opdivo plus chemotherapy improved progression-free survival versus chemotherapy in first-line lung cancer patients whose tumors do not express PD-L1. Taken together with the totality of CheckMate -227 data presented to date, the results reinforce that TMB status provides clinically relevant information for Opdivo-based combinations and that Opdivo plus low-dose Yervoy provided durable efficacy in patients with high TMB." Results from Part 1b of CheckMate -227 will be presented today from 3:12-3:24 PM CDT during the Lung Cancer-Non-Small Cell Metastatic oral abstract session at the American Society of Clinical Oncology Annual Meeting.

07:03 EDT MediWound announces marketing authorization from South Korea for NexoBrid - MediWound announced receipt of authorization from the Ministry of Health in South Korea to market and distribute NexoBrid for the removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns. BL&H Co., Ltd., MediWound's exclusive distribution partner in South Korea, received the marketing authorization and intends to launch NexoBrid in South Korea in the second half of 2018. This regulatory approval builds upon NexoBrid's marketing authorization from the European Medicines Agency for the same indication and validates MediWound's strategy of using the EMA approved registration file for seeking approval in international markets.

06:52 EDT Nomad Foods sees Aunt Bessie's acquisition immediately accretive to earnings - Commenting on the transaction, Stefan Descheemaeker, Nomad Foods' CEO said, "We are excited to welcome Aunt Bessie's to Nomad Foods. Aunt Bessie's iconic brand, positive values and strong product credentials align well with our existing portfolio. As our second accretive acquisition in 2018, Aunt Bessie's represents another step toward our goal of transforming the frozen food category and building a portfolio of best-in-class food brands. Aunt Bessie's significantly expands our presence within potatoes, one of the largest categories in frozen food, while adding another dimension to our growing portfolio in the United Kingdom." Noam Gottesman, Nomad Foods' Co-Chairman and Founder, commented, "The acquisition of Aunt Bessie's illustrates the power of our value creation model which is fueled by organic revenue growth, strong free cash flow and disciplined M&A. Similar to Goodfella's Pizza, which we acquired earlier this year, Aunt Bessie's is expected to be immediately accretive to earnings while providing complementary category exposure, synergy opportunities and new avenues for growth. We look forward to welcoming the Aunt Bessie's team to our organization and working together to build on their success."

06:49 EDT Owens & Minor names Robert Snead as interim CFO, effective June 1 - Owens & Minor announced that Robert Snead, currently Group Vice President of Finance-Global Solutions, has assumed the additional role of interim CFO of Owens & Minor, effective June 1, 2018, succeeding Richard "Randy" A. Meier, Executive Vice President, CFO, who is leaving the company to pursue other opportunities. The company is engaging a national firm to conduct a search for a permanent CFO. In addition, Michael Lowry, Senior Vice President, Corporate Controller, was named the company's Chief Accounting Officer. Lowry, who joined Owens & Minor in 1988, has held a variety of leadership positions on the finance team. He was named Corporate Controller in 2013. Prior to that, Lowry was the company treasurer for four years starting in 2009.

06:45 EDT Nomad Foods to acquire Aunt Bessie's for approximately EUR240M

06:39 EDT OCI Partners board to review unsolicited tender offer from OCI N.V. - OCI Partners LP confirmed that our affiliate and owner of our general partner, OCI N.V., has commenced an unsolicited tender offer to acquire all of the outstanding publicly held common units representing limited partner interests in OCIP for $11.00 per unit in cash. The offer represents a 10.0% premium over OCIP's closing price on June 1, 2018 and a 16.4% premium over OCIP's 90 trading day volume-weighted average unit price. OCI currently owns 88.25% of the issued and outstanding common units of OCI Partners.

06:37 EDT Transocean COO John Stobart to retire, Keelan Adamson to succeed - Transocean announced that John Stobart, Executive Vice President, COO and Chief Performance Officer, is retiring. Keelan Adamson, the company's Senior Vice President - Operations, has assumed Stobart's responsibilities, effective June 1, 2018.

06:34 EDT Digital Ally announces major victory in legal battle against Axon - Digital Ally (DGLY) is pleased to announce a major victory in its legal battles against Axon Enterprise (AAXN). To date, Axon has filed an ex parte reexamination challenge and four different inter partes review challenges against Digital Ally's patents with the United Stated Patent and Trademark Office. Axon's desperate attempts to have Digital's patents invalidated have all been unsuccessful. Over two years ago and before releasing its Axon Signal product, Axon began its campaign to try to invalidate Digital's patents. The Axon Signal product contains the technology at the heart of Digital's patents and of the patent infringement lawsuit Digital Ally filed against Axon. Its first attempt, an ex parte reexamination, failed. Axon then filed four separate IPR challenges against Digital Ally's Patent Nos. 8,781,292 (the " '292 Patent") and 9,253,452 (the " '452 Patent"). The Patent Office rejected both petitions against the '452 Patent and one of the petitions against the '292 Patent. Further, on June 1, Axon lost again on the last IPR challenging the '292 Patent. In that decision the Patent Office disagreed with every argument of Axon, found all challenged claims of the '292 Patent valid, and noted that Axon "has not demonstrated by a preponderance of the evidence that the challenged claims are unpatentable." Though the '292 Patent is no longer at issue in the Axon litigation, Axon had tied many of its arguments relating to the '452 Patent in the litigation to the pending '292 IPR. With this loss-along with the other four losses-Axon's arguments are now significantly curtailed. The Patent Office's decision yet again confirms the strength and validity of Digital Ally's patents, as well as the inadequacy of Axon's invalidity arguments. This loss largely leaves only infringement and damages to be resolved in the litigation. Additionally, because Axon waited until nearly its one-year bar date to file these IPRs, Axon is now barred from filing any further IPRs against the '292 and '452 Patents. Digital Ally also filed a lawsuit against WatchGuard for patent infringement in 2016 on three different patents, the '292, 452, and '950 Patents. WatchGuard joined Axon in this attempt to invalidate the '292 Patent. Thus, with this loss, WatchGuard's defenses on the '292 Patent are now severely limited leaving, essentially, infringement and damages to be determined. WatchGuard previously lost its challenge on the '950 Patent. WatchGuard is barred from filing any further IPRs challenging any of the three patents asserted against it in the infringement lawsuit. Finally, this win effectively eliminates WatchGuard's ability to argue that the litigation stay should be maintained.

06:18 EDT Hulu reorganization sees departure of Chief Content Officer Joel Stillerman - As Hulu (DIS, CMCSA, FOXA, TWX) announced on Friday that it has hired a new Chief Technology Officer, as well as its first Chief Data Officer, and has put in place a new structure that aligns its executive management and teams around four strategic priorities: the subscriber journey, technology & products, content and advertising. The new structure, effective immediately, will bring more agility, technical stability and alignment on the customer throughout Hulu as it increases its pace of growth and innovation. Dan Phillips, former Chief Operating Officer at TiVo (TIVO), has joined Hulu's executive management team as Chief Technology Officer and will be responsible for aligning the company's technical and product strategy with its core business strategy to more effectively innovate and deliver on consumer and partner needs. With the goal of super-serving Hulu viewers and creating more alignment across the company's consumer-facing teams, Chief Marketing Officer Kelly Campbell is expanding Hulu's marketing organization to assume responsibility for the subscriber journey - from acquisition, engagement and retention, to viewer experience and research - across all of Hulu's on-demand and Live TV plans. In addition, this group will now oversee Hulu's subscriber partnerships, including its current relationships with Spotify and Sprint. This announcement also reflects the departure of Ben Smith, Senior Vice President, Experience, who will retire in July. Moving forward, Hulu's content teams will be organized into two groups, aligned around two core capabilities: 1) acquired on-demand and live content partners, and 2) the creative community for Hulu Originals. Hulu is combining its live TV and subscription video on demand content licensing, acquisition and business functions into a single group, Content Partnerships. Thee company's original programming, and its relationships with creators, producers and studios, will continue being managed by the Hulu Originals team, but will now operate as a dedicated business function, led by Senior Vice President of Content, Craig Erwich, who will report to Hulu CEO Randy Freer. Hulu has appointed Jaya Kolhatkar, former Senior Vice President, Global Data and Analytics Platform for Walmart (WMT) to the newly-created executive management role of Chief Data Officer, reporting to Freer. With this new structure and the related changes in scope, Senior Vice President of Partnerships & Distribution Tim Connolly and Chief Content Officer Joel Stillerman have decided to leave the company. Hulu is conducting a search for a head of the new Content Partnerships group and is eliminating the Chief Content Officer role. Reference Link

06:11 EDT ISS recommends DAVIDsTEA holders vote "FOR" management director nominees - DAVIDsTEA announced that Institutional Shareholder Services recommends that DAVIDsTEA shareholders vote "FOR" all of the management director nominees prior to the company's June 14, 2018 Annual General Meeting. On June 1, DAVIDsTEA announced that Glass Lewis & Co. also recommends that shareholders vote FOR the management director nominees. DAVIDsTEA urges shareholders, no matter how many shares they own, to vote the YELLOW Proxy or Voting Information Form today to support the DAVIDsTEA director nominees. In making its recommendation to vote FOR management's director nominees and WITHHOLD on dissident Herschel Segal, ISS carefully reviewed the facts and arguments made by both sides.

06:10 EDT NanoString announces collaboration with National Cancer Institute - NanoString announced a collaboration with the Cancer Therapy Evaluation Program of the National Cancer Institute to facilitate the clinical validation and utility of novel immune-based gene signatures to better inform treatment decisions. The collaboration supports NCI/CTEP efforts to implement novel strategies to correlate therapeutic treatment with patient response across a range of tumor types by incorporating the PanCancer IO 360TM Gene Expression Panel into select active and future NCI-sponsored clinical trials.

06:07 EDT Tetraphase: Everest Medicines submits IND applicaiton for eravacycline in China - Tetraphase announced that Everest Medicines Limited, a C-Bridge Capital-backed biopharmaceutical company based in China which has the exclusive license to develop and commercialize eravacycline in China, Taiwan, Hong Kong, Macau, South Korea and Singapore , has submitted an Investigational New Drug application to China's Food and Drug Administration for a phase 3 clinical trial of eravacycline in complicated intra-abdominal infections. As a result of the IND submission, Tetraphase will receive a milestone payment of $2.5M. Under the terms of the agreement, Tetraphase may receive future clinical and regulatory milestones of up to $14M as well as sales milestones of up to $20M. Tetraphase is also eligible to receive double-digit tiered royalties on net sales of eravacycline in the Territories. Everest is solely responsible for the development and commercialization of eravacycline in the Territories.

06:03 EDT Insulet announces FDA 510(k) clearance of the Omnipod DASH system - Insulet announced FDA 510(k) clearance of the Omnipod DASH Insulin Management System. This clearance lays the foundation for a steady cadence of innovation that furthers Insulet's mission to empower users to enjoy simplicity, freedom, and healthier lives with their differentiated technology. Submission for FDA 510(k) clearance of the Omnipod DASH was announced in January, and while this clearance allows Insulet to commercialize this product in the United States, the company is taking a measured approach through a limited market launch to ensure an ideal user experience at full market release. Full market release is estimated to begin in early 2019 in the United States.

05:47 EDT SAP announces partnership with Accenture, others - SAP (SAP) announced plans to collaborate with Accenture (ACN), Capgemini and Deloitte to accelerate customer adoption of SAP S/4HANA Cloud in the process manufacturing, discrete manufacturing and service industries. Together, the companies intend to develop innovative solutions to deliver on the promise of the intelligent enterprise. Customers will benefit from differentiated industry capabilities and fast innovation cycles with SAP S/4HANA Cloud, SAP's flagship intelligent ERP solution. The co-development initiatives will cover broad aspects, from working together with pilot customers to joint innovation, development and go-to-market strategies. Key focus areas will include support for industry-specific, next-generation business processes powered by artificial intelligence as well as automation within SAP S/4HANA Cloud.

05:40 EDT Qiagen welcomes new guidelines from AAP for detecting TB infection in children - Qiagen announced that it welcomes new guidelines from the American Academy of Pediatrics, or AAP, that recommend screening at-risk children as young as two years old for latent tuberculosis, or TB, infection. The AAP guidelines include recommendations regarding testing with interferon gamma release assays, or IGRAs, such as Qiagen's QuantiFERON-TB Gold, or QFT, or QuantiFERON-TB Gold Plus, or QFT-Plus. The new standards were published June 1st in the association's Red Book: 2018 Report of the Committee on Infectious Diseases. The pediatric guidelines come as authorities around the world are expanding the role of latent TB screening in global tuberculosis control efforts. For example, the World Health Organization recently endorsed the use of IGRAs for diagnosis of latent TB infection and cited QuantiFERON-TB Gold as one of two recommended alternatives to tuberculin skin tests in its Essential Diagnostics List. Starting October 1, 2018, the U.S. Centers for Disease Control will require use of an FDA-approved IGRA for tuberculosis screening and will no longer allow use of the tuberculin skin test for immigration screening, including for children under age 5. Other organizations also have expanded their recommendations.

05:26 EDT Erytech Pharma to present data from Phase 2/3 trial of eryaspase at ASCO - Erytech Pharma announced that it will present pharmacodynamic characterization data from its Phase 2/3 trial of eryaspase in combination with chemotherapy for the treatment of relapsed acute lymphoblastic leukemia, or ALL, at the American Society of Clinical Oncology, or ASCO, Annual Meeting, being held June 1-5, 2018 in Chicago, Illinois.