Stockwinners Market Radar for May 14, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:58 EDT FDA approves Pfizer's Bavencio+Inlyta for advanced renal cell carcinoma - EMD Serono, the biopharmaceutical business of Merck KGaA (MKGAY) and Pfizer (PFE) announced that the FDA has approved BAVENCIO, or avelumab, in combination with INLYTA, or axitinib, for the first-line treatment of patients with advanced renal cell carcinoma. This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC. The approval of BAVENCIO in combination with INLYTA was based on positive results from the Phase III JAVELIN Renal 101 study, in which the combination significantly improved median progression-free survival compared with sunitinib by more than five months in the intent-to-treat patient population. The European Medicines Agency validated the Type II variation application for BAVENCIO in combination with INLYTA in advanced RCC in March 2019, and a supplemental application for BAVENCIO in combination with INLYTA in unresectable or metastatic RCC was submitted in Japan in January 2019.

18:49 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: YogaWorks (YOGA) up 20.7%... Container Store (TCS) up 14.6%... Tilray (TLRY) up 5.0%... OncoCyte (OCX) up 2.8%... Amdocs (DOX) up 0.6%. ALSO HIGHER: Legg Mason (LM) up 0.9% after WSJ speculation the company may be target of activist action by Trian. DOWN AFTER EARNINGS: Sunworks (SUNW) down 27.0%... Agilent (A) down 9.4%... Fortuna Silver Mines (FSM) down 8.0%... New Relic (NEWR) down 4.3%... 8x8 (EGHT) down 4.1%. ALSO LOWER: Virtu Financial (VIRT) down 6.3% after equity offering... JinkoSolar (JKS) down 5.9% after equity offering... Western Asset Mortgage (WMC) down 4.7% after equity offering. Movers as of 18:30ET.

18:33 EDT Werner approves 5M shares repurchase program - Werner Board approved a new stock repurchase program under which Werner is authorized to repurchase up to 5 million shares of its common stock. Upon approval of the new program, the Board withdrew the previous stock repurchase authorization, which had approximately 2.0M shares remaining available for repurchase. Werner may repurchase stock from time to time depending on market, economic and other factors. The new authorization will continue in the future, unless withdrawn by the Board of Directors.

18:24 EDT Adobe CEO: Our exposure to China is 'fairly minimal' - In an interview on CNBC's Mad Money, Adobe CEO Shantanu Narayen said: We are involved in every aspect of supporting businesses... We learn from our customers... You have to partner with an ecosystem to provide a real-time experience for the customer... Our ServiceNow partnership is a natural fit... Design and creativity have never been more important to businesses... With Amazon getting into businesses, the need to transform is front and center for everyone... People are consuming more digital content.

17:42 EDT User-Friendly urges Rand Capital shareholders to vote against East Asset deal - User-Friendly Phone Book, the largest shareholder of Rand Capital, owning 1,455,993 shares or approximately 23% of the company, committed to push for positive change at Rand on behalf of all shareholders. Upon shareholders rejecting the flawed take-over by East Asset Management, which would give away control of the company at a 41% discount to the company's net asset value, User-Friendly intends to take actions to effect significant change in Rand's board of directors, including proposing its own slate of directors and, if necessary, demanding the company to call a special meeting of shareholders for the election of directors. User-Friendly is confident that with new, qualified and independent directors, the company can perform a comprehensive review of all strategic options, leading to an outcome that yields substantially more value for Rand shareholders than the proposed transaction with East. User-Friendly continues to urge Rand shareholders to vote AGAINST Rand's proposed transaction with East using the WHITE proxy card at the special meeting of shareholders scheduled to take place on May 16. Bruce Howard, CEO of User-Friendly, said, "We believe the proposed transaction with East Asset Management transfers control of Rand at a substantial discount to Rand's true value, exploiting Rand's poor performance under its current management and board of directors. We have spoken with many Rand shareholders who share our deep concern and desperately want an alternate path in order to maximize the value of their investment. For this reason, we intend to push for meaningful change in Rand's board of directors once shareholders have rejected this takeover by East."

17:25 EDT Ascent Capital trading halted, news pending

17:21 EDT Tilray CEO says progress being made is accelerating entry into U.S. markets - CEO Brendan Kennedy alo says: ""We have made significant progress integrating our recent acquisitions of Manitoba Harvest and Natura Naturals, accelerating our entry into the United States hemp and CBD markets, and increasing our production and manufacturing capacity in North America and Europe."

16:53 EDT VOXX signs non-binding LOI to sell real estate in Pulheim, Germany - VOXX International announced financial results for its Fiscal 2019 fourth quarter and year ended February 28. The Company also provided updates on its corporate realignment program and other material updates related to its business operations and outlook.Net sales for the Fiscal 2019 year ended February 28 were $446.8M, as compared to $507.1M in the comparable year-ago period, a decline of $60.3M. In conjunction with the realignment of the international accessories business, the Company signed a non-binding Letter of Intent to sell its real estate in Pulheim, Germany, with anticipated gross proceeds of approximately $12.0 million. This pending sale is made possible by the successful consolidation of Oehlbach and Schwaiger into one facility. This sale, upon closing, will further strengthen the Company's cash position and balance sheet. As also communicated on April 29, 2019, the Company has a new reporting structure, which took effect on March 1, 2019. This move is in line with the restructuring initiatives that began in the prior Fiscal year, and which will continue in Fiscal 2020. The Company believes that as a result of the restructuring, it will be able to operate with a significantly lower cost structure and generate greater efficiencies.

16:45 EDT Equus Total Return reports net assets of $46.6M as of March 31, 2019 - Equus Total Return reports net assets as of March 31, 2019, of $46.6M, an increase of approximately $3.1M since December 31, 2018. Net asset value per share increased to $3.44 as of March 31, 2019 from $3.22 as of December 31, 2018.

16:32 EDT Inspire Medical announces publication of results for Inspire therapy study - Inspire Medical announced the publication of clinical results comparing the effects of Inspire therapy on Medicare-aged patients to younger patients. The study, led by physicians at the University of Alabama at Birmingham, followed 235 Medicare-aged patients and 365 younger-aged patients and collected information regarding sleep apnea severity, quality of life and any complications with the procedure. The results of the study demonstrated that while all patients positively responded to Inspire therapy, the Medicare-aged patients had both a slightly higher response, as well as a slightly higher adherence, to therapy. The study noted that an age equal to or greater than 65 years is an independent factor for success with Inspire therapy as compared with younger cohorts. The paper concluded that Inspire therapy should be considered in the treatment of older patients who are CPAP intolerant and eligible per the established inclusion criteria.

16:31 EDT Copa Holdings reports April traffic down 0.9%, capacity down 3.5% - For the month of April, Copa Holdings' system-wide passenger traffic decreased 0.9% year over year, while capacity decreased 3.5%. As a result, system load factor for the month was 84.1%, 2.2 percentage points higher than April 2018.

16:22 EDT CapStar Financial appoints Timothy Schools CEO - The board of CapStar Financial Holdings announced that, effective May 13, Claire Tucker will step aside as president of the company and as president and CEO of CapStar Bank and will be succeeded by Timothy Schools. Schools will be president and CEO of the bank and president of the company, and Tucker will continue as CEO of the company. On July 31, Schools will succeed Tucker as CEO of the company. Tucker will then serve as founding president and CEO Emerita until May 31, 2021.

16:17 EDT SemCAMS Midstream, Keyera to build Canadian liquids pipeline system - SemCAMS Midstream announced it has entered into an asset joint venture with Keyera Corp. to construct a natural gas liquids, or NGL, and condensate pipeline system to connect the liquids-rich Montney and Duvernay production areas of northwestern Alberta to the fractionation and condensate hubs in Fort Saskatchewan, Alberta. This pipeline system provides producers additional and alternative transportation solutions to meet growing production and is supported by long-term contracts with significant take-or-pay commitments. SemCAMS Midstream and Keyera will be equal partners on the project, with Keyera acting as operator. SemCAMS Midstream is a joint venture between SemGroup Corporation (SEMG) and KKR (KKR).

16:16 EDT Amdocs' cloud native digital solutions to be deployed by Sprint - Amdocs announced Sprint's implementation of Amdocs' digital suite of products and services to modernize Sprint's Commerce and Product Catalog operations. This project is part of Sprint Chief Operating Officer Nestor Cano's IT modernization journey to reduce operational expenditures while delivering more robust offerings, enabling quicker delivery cycles and responding more proactively to customer needs. Sprint has deployed Amdocs' microservices development and deployment suite to efficiently and quickly deliver market offerings as well as serve as the backbone for future Sprint developments. Amdocs' digital commerce and flexible catalogue allows Sprint to reduce the large number of catalogues to one unified solution, enabling quicker delivery of more offerings combined with significant operational efficiencies.

16:14 EDT AT&T continues to expect FY19 wireless service revenue to grow - The company provided an update to shareholders at the JP Morgan and MoffettNathanson Conferences stating: "AT&T continues to expect FY19 wireless service revenues to grow, which it expects will contribute to wireless EBITDA growth. The Mobility segment represents about half of AT&T's total EBITDA. Catalysts for growth include postpaid smartphone adoption, the move to higher-ARPU unlimited plans and continued Cricket subscriber growth. The company also expects its FirstNet build and superior network quality will help it attract and retain customers... AT&T has mobile 5G in parts of 19 cities today and expects to have nationwide 5G coverage by early 2020. AT&T also plans to offer two 5G smartphones in 2019, which it expects to promote to early adopters. In a recent test on its live 5G network and using a commercially available device, AT&T saw data speeds faster than 2 Gbps."

16:13 EDT NuCana reports Q1 EPS GBP (.17) versus GBP (.20) last year - It has been a good start to the year and we are pleased with NuCana's continued progress," said Hugh S. Griffith, NuCana's Founder and Chief Executive Officer. "In February 2019, we announced two abstracts related to NUC-3373 that were selected for presentation at the American Association for Cancer Research Annual Meeting 2019 in April. NUC-3373 is NuCana's second ProTide in clinical development and is a transformation of the active anti-cancer metabolite of 5-fluorouracil, one of the most widely prescribed anti-cancer agents. Our current findings have shown that NUC-3373 has an additional mechanism of action for promoting anti-cancer activity that is independent of the DNA damage pathway. NUC-3373 inhibits the target enzyme, thymidylate synthase, causing nuclear to cytoplasmic translocation and induction of endoplasmic reticulum stress. We look forward to announcing additional data in 2019 from the ongoing Phase I study of NUC-3373, as well as data from the ongoing Phase 1b study of NUC-3373 in combination with other agents typically combined with 5-FU."

16:11 EDT Principia Biopharma announces $30M milestone payment reached - Principia Biopharma announced that the first patient has been dosed in its partner Sanofi's Phase 2b clinical trial of SAR442168 in patients with relapsing multiple sclerosis, or MS, triggering a $30M milestone payment to Principia.

16:10 EDT Hain Celestial names Kevin McGahren as President, North America - The Hain Celestial Group announced the appointment of Kevin McGahren as the President, North America. In this role, McGahren will be responsible for leading Hain Celestial's teams in North America including marketing and research and development. He will report directly to Hain Celestial's President and CEO, Mark Schiller, and will be a member of the company's Executive Leadership Team. McGahren was most recently the CEO of Dancing Deer Baking Company, a private equity backed natural dessert and snack company.

16:03 EDT AGNC Investment reports estimated tangible net book value of $17.08 per share - The company announced its estimated tangible net book value of $17.08 per common share as of April 30. The estimate of tangible net book value includes deductions for the company's April dividend of 18c per common share, which was declared on April 10 with an April 30 record date.

16:02 EDT Booking Holdings appoints Sue D'Emic as Chief Accounting Officer and Controller - Booking Holdings announced the appointment of Sue D'Emic as Senior Vice President, Chief Accounting Officer and Controller. D'Emic joins Booking Holdings from Time, where she most recently served as Executive Vice President and CFO. D'Emic will oversee Booking Holdings' Tax, External Reporting and Corporate Accounting teams. She will report directly to David Goulden, Booking Holdings' CFO and Executive Vice President.

14:58 EDT Arch Capital officer Maamoun Rajeh sells over $500K in company shares - Arch Capital officer Maamoun Rajeh disclosed in a filing that he had sold 15,000 shares of company shares at an average price of $33.73 per share on May 10. The total transaction value was $505,920.

14:13 EDT AmerisourceBergen jumps $2.39, or 3%, to $78.11 - The move higher in AmerisourceBergen may be related to an analyst note discussing the potential for the company to be a takeover target, according to contacts.

13:04 EDT Mark Cuban says two biggest stock positions remain Netflix and Amazon - Mark Cuban, while being interviewed on CNBC, stated that his two biggest stock positions continue to be Netflix (NFLX) and Amazon (AMZN).

13:03 EDT Square says planning to onboard larger sellers - Says may see compression in take rate due to larger retailers. Says loan loss rates still around 4%. Comments from the J.P. Morgan Global Technology, Media and Communications Conference.

12:54 EDT FTE Networks Inc trading halted, news pending

12:34 EDT Chairman of Camping World Marcus Lemonis buys over $1.1M in company shares - Chairman of Camping World Marcus Lemonis disclosed in a filing that he had purchased 100,000 shares of company stock at $11.24 per share on May 13 for a total transaction value of $1,123,510. Shares of Camping World are up almost 8% to $12.23 per share.

12:03 EDT Castlight Health adds Virta Health and Vida Health to digital health ecosystem - Castlight Health announced it has added two new solutions to its digital health ecosystem: Virta Health and Vida Health. With these partnerships, Castlight will integrate each company's personalized, digital chronic condition solutions into its health navigation platform, which utilizes a flexibile integration architecture to connect with thousands of health vendors, benefits resources, and plan designs.The two companies are part of a growing marketplace of digital therapeutics: online and tech-enabled treatments that encourage behavioral and lifestyle changes to help users manage a condition. "We are excited to introduce Virta Health and Vida Health to our digital health ecosystem to help employers better address some of the costliest and most common conditions among their employee populations," said Pierce Graham-Jones, Senior Vice President of Growth at Castlight Health. "Adding these solutions will help Castlight users better manage conditions including diabetes, high blood pressure, and obesity."

12:00 EDT ProShares Trust Ultra VIX Short Term Futures ETF falls -8.2% - ProShares Trust Ultra VIX Short Term Futures ETF is down -8.2%, or -$3.62 to $40.63.

12:00 EDT Maxar Technologies rises 12.7% - Maxar Technologies is up 12.7%, or 92c to $8.19.

12:00 EDT Key Energy rises 21.3% - Key Energy is up 21.3%, or 57c to $3.24.

11:33 EDT Silicom announces design win in two advanced networking cards - Silicom announced that "a world-leading provider of hyper-converged software-designed storage systems" will be using Silicom's next-generation connectivity solutions to enhance the performance of its newest product lines. "To date, the customer has awarded Silicom a Design Win for two of its advanced networking cards, one of which features an OCP - Open Compute Project - form factor. According to the customer's projections, its orders for these cards will ramp gradually to a level of approximately $1M per year," the company stated. In parallel, the client continues to consider and evaluate additional Silicom cards in a variety of connectivity speeds and form factors for potential future Design Wins. Based on the customer's guidance, its total need for Silicom NICs could rise to approximately $4M per year, the company said.

11:10 EDT DowDuPont announces new global parental leave policy - DuPont announced a new, comprehensive parental leave policy that offers four weeks of paid leave for new parents, including adoptive and same-sex parents. For birth mothers, the four paid weeks are in addition to an enhanced paid maternity leave which has been extended to 12 weeks. The new policy takes effect on June 1 in the United States and across all global locations no later than the end of 2020.

11:01 EDT Commvault names Riccardo Di Blasio chief revenue officer - Commvault (CVLT) announced the appointment of Riccardo Di Blasio to Chief Revenue Officer. In this role, Di Blasio will be responsible for leading all revenue-related activities through increased integration and alignment across all areas of the business. Most recently, Di Blasio led DXC Technology (DXC) as Global Head of Sales for VMware Cloud Platform Services.

10:44 EDT Aspen Insurance names Mike Cain Group COO - Aspen Insurance Holdings Limited announced several changes to its executive leadership team to support continued operational improvement in the business. Mike Cain, previously Group General Counsel, has been appointed Group Chief Operating Officer and will remain Chief Executive Officer of Aspen UK for a transition period, subject to regulatory approval. Meanwhile, Tim Aman, in addition to his current role as Group Chief Risk Officer, will assume lead responsibility for outward reinsurance/Retro analysis, structuring and placement. Group CIO Bryan Astwood has been named to the Group Executive Committee while Jonny Atkinson, in addition to his current role as Global Head of Insurance Marketing and Distribution, has been appointed Head of Insurance London. Zahir Petiwalla, Performance Officer and Chief Operating Officer, Aspen Re, has been appointed Deputy Group Chief Operating Officer. Aspen also announced today that Aspen Insurance UK Limited has served notice of termination of the agency agreement between AIUK and Aspen Risk Management Limited. As a result, Aspen expects the business will be placed into runoff. Aspen is working with the management of ARML to ensure all policyholder obligations and service requirements are fully supported and consistent with Aspen's standards of policyholder and broker service. This decision has no impact on Aspen's mainstream UK Property and Casualty business. Additionally, Aspen announced that it has begun the process of closing its Dublin office as a result of the proposed move of its Dublin Excess Casualty underwriting business to London.

10:15 EDT MNG tells Gannett holders 'investment is in peril,' asks for director votes - MNG Enterprises, the largest active shareholder in Gannett Co. with an approximate 7.4% ownership interest, sent an open letter to shareholders today in advance of the company's annual meeting on Thursday, May 16. MNG urged shareholders to vote for all three of its director nominees: Heath Freeman, Dana Needleman and Steven Rossi. "We believe your investment is in peril - Gannett is operating in a declining industry, chasing a risky and unprofitable digital transformation strategy, without a proven leadership team," MNG said the letter. It added, "Our nominees, if elected, would serve as that catalyst for change and value creation. Further, they are committed to conducting a full strategic review to explore all possible ways to enhance value for all Gannett shareholders."

10:05 EDT Providence Service, LogistiCare promotes Julie Correll to CCO - The Providence Service Corporation and LogistiCare announced the promotion of Julie Correll to chief compliance officer. In this role, Julie is responsible for implementing and leading all Medicare / Medicaid program integrity compliance activities, including conducting ethics investigations and risk assessments, overseeing auditing and monitoring activities, and working with clients and law enforcement on issues pertaining to fraud, waste, and abuse. Prior to her appointment, the 30-year industry veteran, who began her career at LogistiCare in 2013, served as the company's associate general counsel and ethics and compliance officer.

09:47 EDT ProShares Trust Ultra VIX Short Term Futures ETF falls -6.1% - ProShares Trust Ultra VIX Short Term Futures ETF is down -6.1%, or -$2.70 to $41.55.

09:47 EDT Myovant Sciences falls -20.7% - Myovant Sciences is down -20.7%, or -$3.57 to $13.65.

09:47 EDT Seadrill rises 6.5% - Seadrill is up 6.5%, or 45c to $7.35.

09:40 EDT Ralph Lauren says taking more 'cautious' approach to inventory

09:34 EDT Vuzix announces long-term MicroLED supply agreement with Plessey - Vuzix and Plessey announced an exclusive display device design and long-term supply agreement. "This agreement will support the development and production of next-generation AR products and solutions that combine Plessey's microLED light source technology with Vuzix' extensive expertise and IP in smart glasses and essential optics technologies," the companies said.

09:32 EDT Grow Generation acquires GreenLife Garden Supply; financial terms not disclosed - GrowGeneration announced that it has purchased the assets of GreenLife Garden Supply, with 2 locations in Maine and 1 location in New Hampshire. Following the acquisition, GrowGen now has 5 retail and warehouse locations servicing the growing number of commercial cultivators in the New England market. GrowGen CEO said: "GreenLife marks our 5th acquisition in 2019, adding $7M in revenue to our Company. GreenLife, strategically located in the heart of New England, adds one of the largest and highest volume hydroponic chains in the country. Further, this acquisition positions the Company well to service the adjacent states, New York and New Jersey, that have been actively moving towards adult-use legalization. GreenLife has a seasoned team and we are excited that the founder, Sean Reardon will be continuing in an executive sales and business development role for GrowGen."

09:20 EDT Argo Group urges shareholders to vote for director nominees - Argo Group International sent a letter from the independent directors of Argo's Board of Directors to Argo's shareholders, which read in part, "We are pleased to note that the leading independent proxy advisory firm, Institutional Shareholder Services, has recommended that Argo shareholders vote FOR all five of Argo's nominees and AGAINST all of Voce's nominees. ISS concluded that Voce failed to make a case for its slate of nominees, "particularly given the company's strong performance and a thoughtful refreshment process that has resulted in the addition of appropriate skill sets to the Board over the past two years." In making its recommendation, ISS highlighted that "the company has delivered strong TSR over the short- and long-term and has demonstrated good overall governance." ISS also noted that Argo's Board's "ongoing refreshment process...incorporates active, contributing, and additive Board members." We urge you to vote TODAY on the WHITE proxy card FOR ALL of the Argo nominees in proposal 1 and AGAINST each of proposals 5 through 12, which are Voce's proposals to remove and replace Argo's highly qualified directors with Voce's nominees. Over the past several months, we have shared with you how our directors' robust oversight is enhanced by your Board's commitment to ongoing refreshment practices that ensure the Board has the right skill set to drive continuous performance improvements that we believe will deliver best-in-class shareholder returns. We have detailed the merits of our distinctive specialty insurance franchise, built by our management team, overseen by your Board of Directors and predicated on underwriting excellence, prudent investment management and thoughtful capital allocation. We have provided you with objective facts and reasoned analysis, not "flashy diatribe." Our strategy is delivering strong results with more success to come...Argo urges shareholders to vote the WHITE proxy card "FOR" all of the Company's highly qualified director nominees in connection with Argo's Annual Meeting of Shareholders."

09:18 EDT Ralph Lauren says store openings were slightly below goal in FY19 - Says has 15M Instagram followers across brands, up 45% vs. last year. Says accessories expected to play meaningful role later in long-term plan. Says remains "highly selective" on real estate locations, says was slightly below store openings goal in 2019. Comments from Q4 earnings conference call. Shares of Ralph Lauren are down 1% in pre-market trading.

09:16 EDT Sonos to integrate Google Assistant into sound experience - Sonos (SONO) brings the smart control of the Google Assistant (GOOG, GOOG) to Sonos' sound experience. Use voice with the Google Assistant built-in to Sonos One or Sonos Beam, or with a connected Google Home product to easily start a song, queue a TV show, check the weather, and control the smart home. The free software update will be available starting today in the United States. Support in the UK, Germany, Canada, Australia, France, and The Netherlands comes in July with additional countries to follow on a rolling basis over the coming months. The Google Assistant is Sonos' second built-in voice assistant. Customers on Sonos will have the ability to choose an assistant for each individual speaker, with multiple voice assistants on a single system. With the Google Assistant on Beam in the living room and Alexa on the Sonos One in the kitchen, start a song with the Google Assistant, ask Alexa what's playing, and vice versa. Not just music and TV, Sonos will support the Google Assistant's top first party actions and features, including Continued Conversation, Broadcast mode, and the ability to choose a different voice for the assistant. Bringing the richness of the Google ecosystem and integration within the smart home, the Google Assistant on Sonos also includes more than one million actions from partner products. Additional features and actions will be available through ongoing updates, bringing even more to the Google Assistant experience on Sonos.

09:14 EDT Hilton, Lyft announce new loyalty partnership - Hilton Honors (HLT) announced a "first of its kind travel and hospitality partnership" with Lyft (LYFT). "Created to reward the over 89 million Hilton Honors loyalty members in their everyday lives, the new program will now allow members to earn Hilton Honors Points whenever they ride with Lyft. And in a first for the hospitality industry, later this year members will also be able to redeem Hilton Honors Points for Lyft credits." Hilton Honors members will earn 3 Points per $1 spent on Lyft rides and 2 Points per $1 on Lyft shared rides, for a total of up to $10,000 in Lyft spend per year. "Later this year, members will be able to redeem their Points for Lyft credits, too. Nearly 90 percent of Hilton hotels in the U.S. and Canada are located in areas that Lyft operates, making it easy for Hilton Honors members to take advantage of Lyft's wide reach when they're on the road."

09:11 EDT Fly Intel: Pre-market Movers - HIGHER: Sarepta (SRPT), up 4% after competitor Solid Biosciences (SLDB) disclosed additional safety events with the first patient treated at the new high dose in its Phase 1/2 micro-dystrophin gene therapy study in Duchenne muscular dystrophy... Facebook (FB), up 1% after Reuters reported the company is moving toward an agreement with the government regarding its privacy policies and practices that would put the social media company under 20 years of oversight. The deal could potentially resolve an investigation on whether the company breached a similar 2011 consent pact... Tyson Foods (TSN), up 1% after Credit Suisse upgraded the stock to Outperform and Argus upgraded it to Buy... Athersys (ATHX), up 6% after announcing that its clinical program evaluating MultiStem cell therapy for the treatment of Acute Respiratory Distress Syndrome has received fast track designation from the FDA... TransEnterix (TRXC), up 2% after BTIG analyst Sean Lavin upgraded shares to Buy from Neutral with a $3 price target. UP AFTER EARNINGS: CyberArk (CYBR), up 6%... Allot Communications (ALLT), up 2%. DOWN AFTER EARNINGS: Ralph Lauren (RL), down 1%... Limoneira (LMNR), down 10%... Tencent Music (TME), down 8%. ALSO LOWER: Solid Biosciences, down 40% after disclosing that it reported a serious adverse event to the FDA related to the company's SGT-001 gene therapy trial.

09:09 EDT Adamis Pharmaceuticals announces conditional acceptance of Zimhi name from FDA - Adamis Pharmaceuticals announced conditional acceptance by the FDA of the proposed brand name for the company's high dose naloxone product candidate. The notification to the company from the FDA noted that after review, the proposed proprietary name Zimhi was conditionally acceptable.

09:07 EDT Homology Medicines announces fast track designation for HMI-102 - Homology Medicines announced that the FDA has granted fast track designation for HMI-102, Homology's one-time gene therapy development candidate for the treatment of adults with phenylketonuria, or PKU. PKU is an inborn error of metabolism primarily caused by mutations in the PAH gene that lead to phenylalanine hydroxylase, or PAH, deficiency resulting in the inability to breakdown phenylalanine, an essential amino acid found in natural protein.

09:04 EDT AudioCodes' SBC family tested with Amazon Chime Voice Connector SIP service - AudioCodes (AUDC) announced that its Mediant session border controller, or SBC, family has been successfully tested with the Amazon Chime Voice Connector SIP trunking service. Amazon (AMZN) Chime Voice Connector enables customers to place cost-effective, secure telephone calls to over 100 countries from an on-premises phone system, using an existing internet connection or AWS Direct Connect. The AudioCodes Mediant suite of SBCs, which includes cloud-native, virtualized and appliance models, enables organizations to connect securely and reliably to the Amazon Chime Voice Connector service.

09:02 EDT Aviat Networks signs global frame agreement with Ooredoo Group - Aviat Networks announced a 5-year global supplier frame agreement with Ooredoo, an international telecommunications company headquartered in Qatar with ten operating companies in the Middle East, North Africa, and Southeast Asia. This agreement enables all Ooredoo operating entities around the world to purchase Aviat's complete portfolio of wireless transport solutions. This agreement was initiated based on Aviat's recent deployments with Ooredoo in Southeast Asia. Ooredoo is leveraging Aviat's solutions to lower overall capital expenditures and operating expenses, while also ensuring high availability and very high bandwidth connectivity for mobile backhaul and fixed internet connectivity.

08:40 EDT Kandi Technologies announces stock repurchase program up to $20M - Kandi Technologies announced that its board has approved the company to implement a stock repurchase program to purchase up to $20M of the company's common stock between a certain price range. The program is to be completed by the end of the 2019.

08:38 EDT Cerus says INTERCEPT system offers alternative to year-round Babesia testing - Cerus Corporation announced that the FDA has issued a final guidance document recommending protocols for reducing the risk of transfusion transmitted Babesiosis. In 15 Babesiosis endemic states, treating donated blood components with the INTERCEPT Blood System is a recognized alternative to year-round Babesia testing using a DNA-based test. The FDA Guidance Document recognizes year-round implementation of an FDA-approved pathogen reduction technology or testing donated blood and blood components for Babesia with a licensed DNA-based test when collected in Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, Wisconsin and Washington D.C.

08:35 EDT Soliton: Japanese Patent Office issues notice of grant of patent Number 6503302 - Soliton announced that the Japanese Patent Office has issued a notice of grant of patent Number 6503302, "Rapid Electrohydraulic Shockwave Generator."

08:33 EDT Remark Holdings awarded $6M contract - Remark Holdings announced a $6M contract for 2019 to deploy an additional 15,000 AI Driven Terminals for its Pharmacy Patient Terminal System. Building upon the successful initial deployment of its AI-driven pharmacy terminal network in Sichuan province in the Q4 of 2018, upon which 5,000 Terminals were delivered and recognized as revenue, Remark is expanding its deployment to 30 cities, and 15,000 additional stores, covering more than 10,000 doctors and medical teams and serving over 40M patients, while issuing more than 100,000 prescription every day. There are approximately 480,000 pharmacies in total in China.

08:32 EDT Heron Therapeutics announces results from pain management study with HTX-011 - Heron Therapeutics announced results of a multi-center postoperative pain management study in 93 patients that provides real-world evidence of opioid-free recovery in patients undergoing outpatient inguinal hernia repair surgery who received the investigational agent, HTX-011, together with a scheduled background regimen of generic over-the-counter, or OTC, oral analgesics, or acetaminophen and ibuprofen. This study is the initial phase of the HOPE, or Helping Opioid Prescription Elimination, Project, which is designed to substantially reduce opioid prescriptions following surgery with HTX-011 as the foundation of a multimodal analgesic regimen. Currently, the average patient in the U.S. undergoing inguinal hernia repair surgery receives a discharge prescription for 30 opioid pills. Patients in this real-world outpatient study were discharged approximately 2-3 hours following surgery, and those who met prespecified criteria were discharged without a prescription for opioid analgesics. 95% of patients receiving HTX-011 with the OTC analgesic regimen did not require opioids to manage their postoperative pain through recovery.

08:15 EDT ResTORbio appoints Lloyd Klickstein as CSO - ResTORbio (TORC) announced the appointment of Lloyd Klickstein as CSO. Klickstein brings to ResTORbio a background in drug discovery and development for new clinical indications with high unmet medical need. Prior to joining resTORbio, Klickstein was the global head of translational medicine for the new indication discovery unit and the exploratory disease area at Novartis (NVS), where he led teams that brought forward multiple programs in a wide array of therapeutic areas including the research and development of small molecules for nonalcoholic steatohepatitis, gene therapy for hearing loss, gene editing for sickle cell anemia and TORC1 inhibitors for diseases of aging.

08:12 EDT InflaRx commences second Phase 2 trial of IFX-1 - InflaRx announced the treatment of the first patient in IXchange, a Phase 2 study with IFX-1 in patients with ANCA-associated vasculitis, or AAV. AAV is a rare and life-threatening autoimmune disease in which activation of the complement system, and specifically generation of C5a, is believed to play a key role in the neutrophil-driven vessel inflammation that defines the disease. The disease affects approximately 40,000 and 75,000 patients in the United States and Europe, respectively. The main objective of this randomized, double-blind, placebo-controlled Phase II study is to evaluate the efficacy and safety of IFX-1 in patients with moderate to severe AAV. The trial is planned to enroll approximately 80 patients at about 60 sites in up to 12 European countries and Russia. The study will be conducted in two parts. In Part 1, patients are being randomized to receive either IFX-1 plus a reduced dose of glucocorticoids, or placebo plus a standard dose of glucocorticoids. Patients in both arms will receive the standard of care dosing of immunosuppressive therapy. Prior to starting Part 2 of the study, an independent data monitoring committee will evaluate the efficacy and safety results from Part 1 and recommend if the study should continue. Part 2 will evaluate if treatment with IFX-1 alone is as effective as IFX-1 in combination with glucocorticoids. Thus, in Part 2 patients will be randomized to receive IFX-1 plus placebo glucocorticoids versus placebo plus a standard dose of glucocorticoids. Patients in both arms will receive standard of care immunosuppressive therapy. The primary endpoint of the study is a 50% reduction in Birmingham Vasculitis Activity Score, or BVAS, at week 16, an endpoint that has been used in the previous AAV studies. Secondary efficacy endpoints being analyzed include clinical remission, evaluation of the Vasculitis Damage Index, reduction of glucocorticoid toxicity, several relevant biomarkers like glomerular filtration rate and patient reported outcomes.

08:08 EDT Ralph Lauren raises quarterly cash dividend by 10% to 68.75c per share - Ralph Lauren announced that its board declared a 10% increase in the regular quarterly cash dividend on the company's Common Stock. The new quarterly cash dividend is 68.75c per share for a total annual dividend amount of $2.75 per share. The next quarterly dividend is payable on July 12, to shareholders of record at the close of business on June 28.

08:05 EDT Infrastructure and Energy Alternatives announces $50M equity commitment - Infrastructure and Energy Alternatives (IEA) announced that it has entered into a $50M equity commitment agreement with a fund managed by the Private Equity Group of Ares Management Corporation (ARES) and funds managed by Oaktree Capital Management, L.P. (OAK). Under the terms of the commitment, the funds have agreed to purchase $50M of newly created Series B Preferred Stock from the company, subject to certain terms and conditions, including making certain amendments to the company's credit agreement and approval of the issuances by NASDAQ. Ares and Oaktree will receive warrants with an exercise price of 1c per share for the purchase of up to 10% of the company's common stock on a fully diluted basis with the opportunity to obtain warrants for up to an additional 6% of the company's outstanding fully diluted common stock based on the company's failure to meet certain performance targets. The proceeds from the sale of the Series B Preferred Stock will be used for working capital and to reduce outstanding borrowings under the company's revolving credit facility. The transaction is expected to close on or before May 20, 2019, subject to satisfaction of applicable closing conditions. Following the closing of the transaction, Ares will be entitled to appoint one director to the company's Board of Directors. A special committee of the company's Board of Directors consisting solely of independent disinterested directors reviewed and approved the terms of the preferred stock issuance. JP Roehm, CEO of IEA commented, "We are honored to have Ares as an investor in our company. Their commitment, as well as Oaktree's continued support, underscore the strength of our larger, more diversified platform. This capital will further strengthen our balance sheet and provide us the financial flexibility we need to execute our 2019 business plan and drive value creation for our shareholders."

08:04 EDT Lipocine announces TLANDO NDA PDUFA action date of November 9 - Lipocine announced that the U.S. FDA has accepted its New Drug Application for TLANDO as testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The FDA has assigned November 9 as the Prescription Drug User Fee Act goal date.

08:00 EDT Haemonetics sells facility in South Carolina to CSL Plasma - Haemonetics and CSL Plasma announced an agreement to transfer ownership of Haemonetics' Union, South Carolina, manufacturing facility, operating assets and certain inventories to CSL Plasma. The facility produces liquid saline and sodium citrate, which are solutions used in the plasmapheresis, or plasma collection, process. CSL Plasma provides plasma to global biotechnology leader CSL Under the terms of the agreement, at closing of the transaction CSL Plasma will obtain ownership and operational control of the facility, including property and equipment. In addition, through this transaction approximately 200 Haemonetics employees working in the Union, South Carolina, facility will be given the opportunity to become CSL Plasma employees. The transaction is expected to close within the current quarter, subject to the satisfaction of various closing conditions and a regulatory notification. Haemonetics also announced that it has updated its FY20 guidance assuming the closing of the transaction, which is available on the Haemonetics Investor Relations website.

07:43 EDT Myovant Sciences announces LIBERTY 1 trial meets primary efficacy endpoint - Myovant Sciences announced that LIBERTY 1, the first of two Phase 3 studies of once daily relugolix combination therapy met its primary efficacy endpoint and six key secondary endpoints in women with uterine fibroids. Relugolix combination therapy maintained bone mineral density at levels comparable to placebo over 24 weeks and was generally well tolerated. In the primary endpoint analysis, 73.4% of women receiving once daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo. A response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of the 24-week treatment period measured using the alkaline hematin method. On average, women receiving relugolix combination therapy experienced an 84.3% reduction in menstrual blood loss from baseline, a clinically relevant key secondary endpoint. Bone mineral density was comparable between the relugolix combination and placebo groups. The distribution of the change in bone mineral density, including outliers, was similar for the relugolix combination therapy and placebo groups at 24 weeks, as assessed by dual energy x-ray absorptiometry, or DXA. The 24-week study achieved six key secondary endpoints with statistical significance compared to placebo including mean change in menstrual blood loss from baseline to week 24, reduction in pain in women with pain at baseline, improvement in quality of life, amenorrhea defined as no or negligible blood loss, improvement in anemia in those women with anemia at baseline and reduction in uterine volume. The overall incidence of adverse events in the relugolix combination and placebo groups was comparable. In the relugolix combination therapy group 5% of women discontinued treatment early due to adverse events compared with 4% in the placebo group. The only adverse event in the relugolix combination arm occurring in at least 10% of women and more frequently than in the placebo arm was hot flush. There were no pregnancies in the relugolix combination group and one in the placebo group. Myovant expects data from LIBERTY 2, the replicate Phase 3 study evaluating once daily relugolix combination therapy in women with uterine fibroids and heavy menstrual bleeding, in Q3 and, provided the LIBERTY 2 study is successful, plans to submit a new drug application to the FDA in Q4.

07:33 EDT Onconova: Enrollment in Phase 3 IV rigosertib trial in HR-MDS is 'top priority' - "As we progress through 2019, we are advancing the clinical development of our pipeline and executing on our collaboration strategy, as highlighted by the recently announced license agreement for investigational rigosertib in Greater China with HanX Biopharmaceuticals," said Steven M. Fruchtman, M.D., President and CEO. "2019 is an important year for Onconova and we are working diligently to execute on our objectives. If successful, we believe rigosertib could be the first new treatment for higher-risk MDS in more than 15 years." Dr. Fruchtman added, "Enrollment in our Phase 3 intravenous rigosertib trial in second-line HR-MDS patients is continuing and is our top priority. We exceeded 75 percent enrollment of the study during the first quarter and are focused on completing enrollment in the second half of 2019 and reporting top-line data following full enrollment and 288 death events. We believe the addition of sites in Brazil and China later this year could contribute significantly to achieving our goal of completing enrollment by year end. We also look forward in the future to initiating a Phase 3 trial with oral rigosertib in combination with azacitidine in first-line HR-MDS patients and to filing an IND in the U.S. for ON 123300, a first-in-class CDK4/6 + ARK5 inhibitor for the treatment of a variety of advanced tumors." Cash and cash equivalents as of March 31, 2019, totaled $10.4M compared to $17M at December 31, 2018. The company expects that cash and cash equivalents at March 31, 2019 will be sufficient to fund ongoing trials and operations into the fourth quarter of 2019. After receiving the upfront proceeds from the HanX rigosertib transaction, the company expects that its cash and cash equivalents will be sufficient to fund ongoing trials and operations into the first quarter of 2020. Net loss was $7.6M for the quarter ended March 31, 2019, compared to $5.1M for the first quarter ended March 31, 2018. Research and development expenses were $4.1M for the quarter ended March 31, 2019, and $4.6M for the comparable period in 2018. General and administrative expenses were $3.2M for the quarter ended March 31, 2019, and $1.9M for the comparable period in 2018.

07:19 EDT T2 Biosystems announces results from T2Bacteria Panel trial publsihed - T2 Biosystems announced that results from a pivotal trial were published online in the Annals of Internal Medicine journal. The study demonstrated evidence for the first direct-from-blood, non-culture test cleared by the FDA for the diagnosis of bloodstream infections by multiple bacteria. Blood cultures took between 32 and 111 hours to identify pathogens whereas the T2Bacteria Panel took 3.6 to 7.7 hours to do so. In 78% of probable or possible bloodstream infections, or BSIs, subjects had blood culture-negative/T2Bacteria positive results despite treatment with active antibiotics. A total of 24 hours after blood draw, 20% of patients with blood culture-positive/T2bacteria-positive results were still not receiving effective therapy. The T2Bacteria Panel had a 99.7% negative predictive value and an overall sensitivity of 89.7% per subject and per assay. The T2Bacteria Panel had overall specificity of 89.5% per subject and 97.8% per assay.

07:13 EDT McDermott awarded EPCI contract by Petrobras for Sepia field project - McDermott (MDR) announced the award of a significant contract by Petrobras (PBR) for engineering, procurement, construction and installation of subsea risers and flowlines for the first phase of the Sepia field, located 174 miles from the Rio de Janeiro coastline in Brazil. The project scope includes detailed engineering, surveys, supply, installation and pre-commissioning of rigid pipelines, jumpers, buoyance modules, strakes and riser monitoring systems for seven-riser wells (3 producers and 4 injector wells) connected to the floating production, storage and offloading Carioca vessel. McDermott's Rio de Janeiro office will perform the work with support from its Houston office. McDermott plans to use five vessels for the installation work at ultra-deepwater depths up to 7,021 feet. The engineering work is expected to begin immediately, and the contract will be reflected in McDermott's second quarter backlog. The first phase is part of a 15 well Sepia field development located in the pre-salt layer of the Santos Basin in Block BM-S-24. First oil is expected in 2021.

07:09 EDT Cubic unit awarded $68.2M extension contract by LA County MTA - Cubic announced that its Cubic Transportation Systems business division was awarded and has executed a 5 1/2-year, $68.2M extension contract award by the Los Angeles County Metropolitan Transportation Authority to provide field maintenance and technical support services for the TAP reginal fare payment program. The services contract is also linked to two recently awarded contracts for a mobile app and its operations, as well as infrastructure upgrades that will support the app and enhances the overall TAP network to a next-generation payment system. TAP, Metro's contactless fare system that links 26 regional transit providers on a common contactless smart card, is being enhanced to include a leading edge mobile app to complement the Metro-developed cloud wallet, TAPforce.

07:04 EDT Protagonist Therapeutics: Administration of PN-943 was 'safe and well tolerated' - Protagonist Therapeutics announced results from the initial single ascending dose part of the Phase 1 study of PN-943, an oral, gut-restricted alpha-4-beta-7 integrin specific antagonist in development for the potential treatment of inflammatory bowel disease. Results of the first clinical study of PN-943 in a randomized, double-blind, placebo-controlled, dose escalation study in healthy volunteers demonstrated that administration of PN-943 was safe and well tolerated, with no reported serious adverse events. The pharmacokinetic and pharmacodynamic parameters were consistent with the design of PN-943 as a gastrointestinal-restricted alpha-4-beta-7 integrin antagonist. "These dose-finding results are consistent with the preclinical properties of PN-943, including superior target engagement as compared with prior compound PTG-100," commented Samuel Saks, M.D., Protagonist Chief Medical Officer. "PN-943 has been designed with superior potency and a longer half-life of dissociation. In addition, PN-943 applies the oral, gut-restricted, integrin antagonist approach that has been validated by previous studies in ulcerative colitis patients with PTG-100."

06:56 EDT Solid Biosciences reports serious adverse event to FDA related to SGT-001 - Solid Biosciences announced last night with its earnings that two patients have been randomized in the second cohort of the Phase I/II IGNITE DMD study, including one patient dosed with 2E14 vg/kg of SGT-001 and another added to the control group. It added, "Shortly after dosing, the patient in the treatment group was diagnosed with a gastrointestinal infection that was classified as a serious adverse event unrelated to study drug, as well as a transient decline in platelet count that was considered a non-serious adverse event related to study drug; these events have fully resolved. In addition, the patient experienced a transient elevation of transaminases, as well as a transient increase in bilirubin higher than two times the upper limit of normal, which was rapidly resolved with an increase in oral glucocorticoids. This was reported to the FDA as a serious adverse event related to study drug. The patient is doing well and has resumed normal activities. Solid continues to enroll patients in IGNITE DMD per the study protocol and anticipates providing additional data later this year."

06:53 EDT Federal Signal to acquire Mark Rite Lines for initial purchase price of $55.5M - Federal Signal announced the signing of a definitive agreement to acquire the assets and operations of Mark Rite Lines, or MRL, a U.S. manufacturer of truck-mounted and ride-on road-marking equipment for an initial purchase price of $55.5M, subject to post-closing adjustments. In addition, there is a contingent earn-out payment of up to $15.5M. The acquisition includes the operations of HighMark Traffic Services, a wholly-owned subsidiary of MRL, which provides road-marking services, primarily within the state of Montana. MRL, which is headquartered in Billings, Montana and employs approximately 250 people, generated revenues of $67M for the year ended December 31, 2018, with an EBITDA margin of 13%. Its product portfolio of road-marking equipment consists of truck-mounted and self-propelled, ride-on application solutions, which utilize materials including thermoplastics, paint and epoxy, as well as line-removal and pavement-grooving vehicles.

06:40 EDT NGL Energy Partners water solutions business to combine with Mesquite for $890M - NGL Energy Partners announced it has executed a definitive agreement to combine all of the assets of Mesquite Disposals Unlimited with NGL's water solutions business for approximately $890M on a cash-free, debt-free basis. Mesquite SWD will remain the operator of the Mesquite assets led by Mesquite's current management team. The assets consist of a fully interconnected produced water pipeline transportation and disposal system in Eddy and Lea Counties, New Mexico, and Loving County, Texas. At closing the Mesquite system will have 35 salt water disposal wells in total, representing over 1M barrels per day of disposal capacity expected by year-end 2019. The majority of volumes on Mesquite's system are contracted under long-term acreage dedications and minimum volume commitments. Additionally, approximately 95% of the current system volumes are delivered via pipeline. NGL expects the funding for this acquisition to be leverage-neutral and significantly accretive to distributable cash flow per unit in FY20 and beyond. NGL will issue $100M of its 9.625% Class C Fixed-to-Floating Rate Cumulative Redeemable Perpetual Preferred Units to owners of Mesquite, who also have an option to receive 6M common units at a price of $16.00 per unit at closing. Funding of the balance of the consideration is expected to be leverage-neutral to the partnership and not include the issuance of any additional common equity. The transaction remains subject to satisfaction of specified closing conditions, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. NGL expects this transaction to close in July.

06:36 EDT Aphria announces multiple executive appointments - Aphria announced several new executive appointments including James Meiers to the role of COO, Aphria Leamington, Tim Purdie as Chief Information Officer & Chief Information Security Officer, and Maureen Berry as Vice President, Corporate Human Resources. The company also announced that Jakob Ripshtein, Aphria's President, will resign from the company. Ripshtein will remain in his current role until June 7, 2019. His current responsibilities will be shared among the existing senior leadership team.

06:34 EDT Volkswagen expects TRATON IPO before 2019 summer break - The company announced Monday, "Backed by approval from the Supervisory Board, the Board of Management of Volkswagen AG to go ahead with the planned IPO of TRATON SE before the summer break, depending on further developments on capital markets.On March 13, 2019, Volkswagen AG decided not to continue with preparations for an IPO of TRATON SE in light of the difficult market environment at that time. The Board of Management did, however, state it was still aiming for an IPO once market conditions had improved." Reference Link

06:31 EDT Genesee & Wyoming reports April traffic of 255,647 carloads, down 5.4% y/y - G&W's total traffic in April was 255,647 carloads, a decrease of 14,454 carloads, or 5.4%, compared with April 2018. G&W's same railroad traffic in April decreased 815 carloads, or 0.3%, compared with G&W's traffic in April 2018, excluding carloads from G&W's former Continental European intermodal business, which was sold in June 2018, and short line lease expirations in Canada (Goderich-Exeter Railway and Southern Ontario Railway in the fourth quarter of 2018.

06:20 EDT WhatsApp confirms vulnerability, does not name offender - WhatsApp confirmed: "A buffer overflow vulnerability in WhatsApp VOIP stack allowed remote code execution via specially crafted series of SRTCP packets sent to a target phone number." The issue affects WhatsApp for Android prior to v2.19.134, WhatsApp Business for Android prior to v2.19.44, WhatsApp for iOS prior to v2.19.51, WhatsApp Business for iOS prior to v2.19.51, WhatsApp for Windows Phone prior to v2.18.348, and WhatsApp for Tizen prior to v2.18.15. Reference Link

06:12 EDT Achillion granted twentieth patent for factor D Portfolio - Achillion Pharmaceuticals announced that the U.S. Patent and Trademark Office issued U.S. Patent #10,287,301 to Achillion for ACH-5548, its next-generation orally administered complement factor D small molecule inhibitor product candidate. This patent covers the composition of matter of ACH-5548, and a pharmaceutical composition that includes ACH-5548, a key mediator in the complement alternative pathway. This issued patent will be the twentieth patent that the USPTO has granted to Achillion for its complement factor D portfolio of small molecules. Achillion currently has over one hundred global patent applications and patents including the composition of matter and method of use for its complement-related research program.

06:11 EDT Welbilt CEO says sees 'clear path to profitable growth' - "Welbilt has a strong foundation with significant opportunity for enhanced profitable growth," said CEO Bill Johnson. "We have leading brands that customers prefer due to our innovation leadership and our commitment to our channel partners. We are committed to further improving our customers' experience by effectively going to market as a portfolio of brands, making Welbilt the easiest company to do business with in the commercial foodservice equipment industry. We are investing in automated controls, system solutions and connectivity across all of our brands to maintain our leadership in solving customers' system needs." "I see a clear path to profitable growth by continuing to drive brand preference with our customers, being disciplined with our value pricing philosophy and embedding operational excellence throughout the entire organization. We have begun to execute our Transformation Program, which focuses on improving our global manufacturing and distribution operations, procurement, engineering, KitchenCare, sales and marketing and other corporate functions. We have detailed plans to address each of these areas and expect these actions to generate approximately $75 million, or 500 basis points, of run-rate savings by the second half of 2021. We expect to invest between $70 million and $80 million in Transformation Program and restructuring costs to deliver these savings, which provides a payback of approximately one year on this investment. Our focus on enhanced profitable growth and margin expansion will allow us to continue generating strong Free Cash Flow. We intend to focus the majority of our Free Cash Flow on deleveraging our balance sheet by reducing debt. Once strengthened, our balance sheet will become a source of additional growth - allowing us to increasingly invest on internal initiatives and future acquisitions," concluded Johnson.

06:06 EDT Athersys announces Fast Track designation for its MultiStem clinical program - Athersys announced that its clinical program evaluating MultiStem cell therapy for the treatment of Acute Respiratory Distress Syndrome, or ARDS, has received Fast Track designation from the FDA. This important designation is given to qualified investigational therapies that show promise in providing benefit to patients in areas of significant unmet medical need. Fast Track designation allows for an expedited regulatory review process after the clinical data is submitted to help speed development of promising therapies to the market in order to help patients in areas where current standard of care is limited.

06:03 EDT Hydrogenics anticipates increasing activity in space in second half of FY19 - The company said, "Due to our leading role in the world's burgeoning fuel-cell powered rail and bus sectors, we anticipate increasing activity in the space during the second half of 2019. Overall, given our solid balance sheet, strong partnerships, and current demand trends, we remain optimistic about the outlook for meaningful top line growth and improved financial performance this year."

05:54 EDT Orion Group awarded $15M contract from North Carolina State Ports Authority - Orion Group announced a contract award of approximately $15M. The company's Marine segment was recently awarded a contract from the North Carolina State Ports Authority for the construction of the Turning Basin Expansion project in the Port of Wilmington, North Carolina. The company's scope on the project calls for installation of a new bulkhead wall and dredging activities to allow for larger vessels the ability to safely and more efficiently turn around in the Wilmington Harbor. The project is expected to begin in the third quarter with completion planned for early 2020.

05:31 EDT Vodafone cuts FY19 dividend to 9.0 eurocents from 15.07 eurocents in FY18 - Vodafone says its dividend per share is rebased to 9.00 eurocents in FY19 from 15.07 eurocents in FY18), implying a final dividend of 4.16 eurocents. It said, "The Group is at a key point of transformation - deepening customer engagement, accelerating digital transformation, radically simplifying our operations, generating better returns from our infrastructure assets and continuing to optimise our portfolio. To support these goals and to rebuild headroom, the Board has made the decision to rebase the dividend, helping us to reduce debt and delever to the low end of our target range in the next few years."

05:21 EDT Roche announces CE-IVD launch of cobas MTB-RIF/INH test - Roche announced the CE-IVD launch of the cobas MTB-RIF/INH test to detect resistance to antibiotics within tuberculosis DNA. This assay is part of the mycobacteria test menu that includes the cobas MTB and cobas MAI tests for use on the cobas 6800/8800 Systems. This continues the expansion of the testing menu on the cobas 6800/8800 Systems, supporting true consolidation and efficient testing.

05:12 EDT Haemonetics receives FDA clearance for TEG 6s Hemostasis Analyzer System - Haemonetics announced that it received 510(k) clearance from the FDA to expand the medical indication of its TEG 6s Hemostasis Analyzer System for use in adult trauma settings. "This clearance builds on the current indication for the TEG 6s system in cardiovascular surgery and cardiology procedures, making it the first cartridge-based system available in the U.S. to evaluate the hemostasis condition in adult trauma patients." The site-of-care TEG 6s system provides actionable test results in as little as ten minutes.