Stockwinners Market Radar for June 26, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:16 EDT Icahn says it is 'important' to add new directors to Occidental's board - Activist investor Carl Icahn said in a regulatory filing that his firm believes Occidental Petroleum's (OXY) board of directors "have made a number of mistakes in how and at what cost they pursued the Anadarko (APC) transaction." "In the opinion of the Icahn Participants, the path to greater value for the Company's stockholders is through good governance," Icahn said. "More specifically, the Icahn Participants believe it is important to add new directors to Occidental's Board of Directors to oversee future extraordinary transactions like the Anadarko transaction and to ensure that they are not consummated without stockholder approval when appropriate. The Icahn Participants believe that the election of new directors will also help to ensure the achievement of the Board's and management's projected stated cost savings and deal synergies for the Anadarko transaction. Finally, the Icahn Participants believe that the election of new directors, together with the formation of a new Strategic Review Committee of the Board, will help ensure that alternatives to maximize value for stockholders will be considered and, if appropriate, pursued by the Board and management of the Company."

18:04 EDT Investar Holding increases quarterly dividend 5% to 5.5c per share - Investar Holding declared a quarterly cash dividend of 5.51c per share to holders of Investar common stock. The dividend is payable on July 31 to shareholders of record as of July 8. This represents a 5% increase in the dividend per share compared to the prior quarter.

18:00 EDT General Dynamics awarded $217M Air Force Intelligence System Support contract - General Dynamics Information Technology it will support the U.S. Air Force's 480th Intelligence, Surveillance and Reconnaissance Wing through their Technical Operations Support contract. The single-award contract holds a total estimated value of $217M. It includes a nine-month base period with seven one-year options as well as a possible six-month extension.

17:41 EDT Serco Group, BAE Systems awarded not exceed $747.1M combined Navy contracts - BAE Systems (BAESY) and Serco Group (SECCF) have each been awarded a cost-plus-fixed-fee, cost-only indefinite-delivery/indefinite-quantity multiple award contract for logistics, integration, engineering, procurement, fabrication, assembly, test, inspection, zone integration and installation of integrated command, control, communications, computers and intelligence, or C4I, system of systems capabilities aboard new construction aircraft carrier and large deck amphibious ships, to include refueling and complex overhaul ships. Throughout the duration of the awarded contracts, the total obligated amount on orders for all of the awarded contracts combined will not exceed $747.1M. Each contract includes options, which if exercised, would bring the estimated value of each contact to $601.51M for BAE Systems and $608.24M for Serco. These contracts will support various Navy shipbuilding programs. These programs require integrated C4I capabilities to provide communications for maritime operations and flight safety. The integrated capability is composed of distributed systems that provide network capabilities, communications, command and control, intelligence and non-tactical data. Work is expected to be completed by June 2029. No contract funds will be obligated at the time of award. Contract funds in the amount of $50,000 will be obligated on the first task order under each contract utilizing FY17 shipbuilding and conversion, FY19 shipbuilding and conversion and FY19 research and development funds. Contract funds will not expire at the end of the current fiscal year. These contracts were awarded pursuant to full and open competition, with three offers received. The Naval Information Warfare Systems Command is the contracting activity.

17:25 EDT Dova Pharmaceuticals trading halted, news pending

17:22 EDT Verrica Pharmaceuticals spikes over 13% after study outcome for VP-102 - Shares of Verrica Pharmaceuticals are up over 13% or $1.24 to $10.72 per share in after-hours trading.

17:01 EDT Erytech enrolls first patient in Phase 2 Eryaspase clinical trial - Erytech Pharma announced that the first patient has been enrolled in its Phase 2 clinical trial, named TRYbeCA2, evaluating its lead product candidate eryaspase for the treatment of first line triple negative breast cancer. Following the "positive" Phase 2 results with eryaspase in second-line metastatic pancreatic cancer, ERYTECH selected triple-negative breast cancer as the next indication to expand the potential use of eryaspase in solid tumors. TNBC is an aggressive and metabolically active form of breast cancer with high rates of symptomatic metastases. A Phase 2/3 clinical trial in first-line metastatic TNBC, named TRYbeCA2, was designed and the Phase 2 part of the trial was launched in Spain, Belgium, Hungary and the United Kingdom. The trial is evaluating eryaspase in combination with gemcitabine and carboplatin chemotherapy, compared to chemotherapy alone. Target enrollment in the Phase 2 part of the trial is approximately 64 patients. The primary endpoint is objective response rate.

16:51 EDT Investcorp Credit to acquire majority interest in CM Investment Partners - Investcorp Credit Management US LLC, a subsidiary of Investcorp Bank B.S.C., announced that it has entered into a definitive interest purchase agreement to acquire a majority ownership interest in CM Investment Partners LLC, the investment adviser to CM Finance Inc, through its purchase of the respective equity positions held by certain funds managed by Cyrus Capital Partners, L.P. and Stifel Venture Corp., and newly issued interests in CMIP. As a result of the Transaction, Investcorp will become the majority owner of CMIP and Michael Mauer and Christopher Jansen, CMIP's Co-Chief Investment Officers, will together maintain a minority ownership interest in CMIP. Notwithstanding the sale of their respective interests in CMIP, each of Cyrus and Stifel will retain their equity interests in the Company as of the date of the closing of the Transaction, which currently represent a 44.1% interest in the aggregate.

16:45 EDT Washington REIT selling eight retail assets in Maryland and Virginia - WashREIT has entered into two definitive agreements with separate institutional buyers to sell a total of eight retail assets, including all three of its power centers. The company has also provided a blended estimated capitalization rate of approximately 6.2% for the sale of its eight retail assets. The first sale agreement provides for the disposition of five retail assets located in Maryland and Virginia, which total approximately 800,000 square feet and are expected to generate gross proceeds of approximately $485M. The second sale agreement provides for the disposition of WashREIT's power center assets in Maryland, totaling approximately 850,000 square feet. The company plans to announce gross proceeds for the second sale upon completion of the transaction. In additional transactions, WashREIT has contracted to acquire an urban-infill, value-add multifamily asset by late-July for approximately $70M, and has closed on the previously announced sale of Quantico Corporate Center in Stafford, VA, for gross proceeds of approximately $33M.

16:35 EDT Postal Realty Trust declares initial pro-rated dividend - Postal Realty Trust announced that its board has approved the initial dividend on the company's Class A common stock in the amount of 6.3c per share. The initial dividend represents a pro-rated cash dividend for the period from the completion of PSTL's initial public offering on May 17 to June 30. The dividend will be payable on July 31 to stockholders of record as of the close of business on July 9.

16:30 EDT Aclaris Therapeutics trading resumes

16:27 EDT Herman Miller up 9% to $41.15 after Q4 results beat estimates - The company's Q1 profit guidance and midpoint of it's Q1 revenue view also beat estimates.

16:25 EDT Google launches Deep Learning Containers - According to a posting to its AI and machine learning products blog Google said: "Quickly prototype with a portable and consistent environment for developing, testing, and deploying your AI applications with Deep Learning Containers. These Docker images use popular frameworks and are performance optimized, compatibility tested, and ready to deploy. Deep Learning Containers provide a consistent environment across Google Cloud services, making it easy to scale in the cloud or shift from on-premises. You have the flexibility to deploy on Google Kubernetes Engine, GKE, AI Platform, Cloud Run, Compute Engine, Kubernetes, and Docker Swarm." Reference Link

16:20 EDT Yum! Brands names Chris Turner as CFO, effective August 8 - Yum! Brands (YUM) today announced that Chris Turner will join the company as CFO reporting to CEO Greg Creed, effective August 8. In this role, Turner will assume global responsibility for finance, corporate strategy, supply chain and information technology. Turner joins Yum! Brands from PepsiCo (PEP), where he most recently served as Senior Vice President and General Manager. This announcement concludes the previously announced search for Yum! Brands' top financial post, which is currently held by David Gibbs, the company's President, COO and CFO.

16:19 EDT Liquidia Technologies and GlaxoSmithKline restructure collaboration agreement - Liquidia Technologies(LQDA) announced that it has amended its collaboration agreement with GlaxoSmithKline (GSK) for the development and commercialization of pharmaceuticals based upon the Company's proprietary PRINT technology delivered through the inhalation route of administration. The amended collaboration agreement provides the company with the right to develop and commercialize three additional PRINTbased therapeutics delivered via inhalation. Additionally, under the amended collaboration agreement, the Company can acquire rights to pursue additional PRINT based programs for inhalation therapy, subject to GSK's approval. The amended collaboration agreement provides GSK with a right of first negotiation prior to the company entering into a license agreement with a third party for any GSK-approved program developed under this amended collaboration agreement. Any new PRINT-based therapeutic delivered via inhalation developed by the Company under the amended collaboration agreement would carry milestone and royalty obligations due to GSK, beginning with the initiation of a Phase 3 clinical trial. Prior to entering into the amended collaboration agreement, GSK maintained exclusive rights to develop and commercialize any PRINT-based therapeutic delivered via inhalation, with the exception of LIQ861, the Company's Phase 3 product candidate for the treatment of pulmonary arterial hypertension.

16:11 EDT OFG to acquire Scotiabank ops in Puerto Rico, U.S. Virgin Islands - OFG Bancorp (OFG) and Scotiabank (BNS) announced the signing of a definitive agreement for OFG's subsidiary, Oriental Bank, to acquire Scotiabank's Puerto Rico operation for $550 million in cash and Scotiabank's US Virgin Island branch operation for a $10 million deposit premium. Scotiabank's Puerto Rico and USVI operations will be merged into Oriental Bank and its related businesses. The acquisition is subject to customary regulatory approvals.

16:09 EDT Navigator Holdings names Dr. Henry Deans as CEO, effective August 22 - On June 25, the Board of Directors of Navigator Holdings appointed Dr. Henry "Harry" Deans as CEO, effective August 22. David Butters, the company's current President and CEO will relinquish that role to Dr. Deans on that date and continue as Chairman of the Board. Dr. Deans will continue as a member of the Board after the effectiveness of his appointment as CEO.

16:07 EDT Verrica VP-102 achieved positive results on both primary,secondary endpoints - Verrica Pharmaceuticals announced positive topline results from its COVE-1 Phase 2 open label clinical study of VP-102 for the treatment of verruca vulgaris, or common warts. COVE-1 included two cohorts that evaluated the safety and efficacy of VP-102, a novel topical therapy containing a solution of 0.7% cantharidin in a proprietary single-use applicator, in subjects with up to six warts. In both cohorts, VP-102 achieved positive results on both the primary endpoint of complete clearance of all treatable warts at Day 84 and the secondary endpoint of the percentage reduction of warts. VP-102 was well-tolerated with no serious adverse events reported. "This is exciting news for Verrica and our proprietary cantharidin product. Positive Phase 2 data of VP-102 for the treatment of common warts, after the successful Phase 3 results achieved with VP-102 for molluscum contagiosum, further increases our confidence in the broad clinical utility and large market potential of our lead product," said Ted White, President and Chief Executive Officer of Verrica. "We are progressing the development of VP-102 for a broad range of skin diseases. We intend to request an 'End of Phase 2' meeting with the FDA for the treatment of common warts, and remain on track to submit an NDA for the treatment of molluscum contagiosum later this year."

16:06 EDT Aclaris Therapeutics ATI-502 does not achieve statistical superiority in trial - Aclaris Therapeutics announced results from a Phase 2 clinical trial of ATI-502. an investigational topical Janus Kinase, or JAK, 1/3 inhibitor, in patients with alopecia areata, or AA. ATI-502 did not achieve statistical superiority at the primary or secondary endpoints due to high rates of disease resolution in vehicle-treated patients. AA-201 Topical, a Phase 2 randomized, double-blinded, parallel-group, vehicle-controlled trial, evaluated the safety, efficacy and dose response of two concentrations of ATI-502, 0.12% and 0.46%, on the regrowth of hair in 129 subjects with AA. Subjects applied ATI-502 to their scalp twice daily for 24 weeks. The primary endpoint was the mean percent change from baseline in the Severity of Alopecia Tool, or SALT, score at week 24. Secondary endpoints included change in Alopecia Density and Extent, or ALODEX score and multiple investigator and patient reported outcomes. ATI-502 was observed to be generally well-tolerated. Adverse events were primarily mild or moderate in severity. No treatment-related serious adverse events were reported.

16:05 EDT Peck announces $17M pact to construct solar arrays generating 7 MW - The Peck Company announced an initial agreement to construct a portfolio of solar PV arrays generating 7 megawatts for one of its customers. This customer currently owns several hundred million dollars in solar assets and also has a backlog of several hundred million dollars in new projects where they need partners for EPC development, a core competency of The Peck Company. The projected revenue from the portfolio of projects is approximately $17M, and each project is subject to a customary EPC contract. The Peck Company will provide further updates on each specific contract. Peck will begin constructing each commercial-scale project in the portfolio after development has been completed and the project has received a notice to proceed. The projects are all located in the Northeast and have municipal off-takers with low-risk, long-term power purchase agreements. Peck expects to break ground on the projects in July 2019, with a target completion date for this first project portfolio in the first quarter of 2020.

16:03 EDT Pfizer responds to AdComm vote to revise Prevnar 13 recommendation - Pfizer issued a response to the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention's vote to revise the pneumococcal vaccination guidelines and recommend Prevnar 13 for adults aged 65 and older based on the shared clinical decision making of the provider and patient. This vote means the decision to vaccinate should be made at the individual level between health care providers and their patients. "This revised recommendation reinforces that Prevnar 13 is considered safe and effective by the FDA and ACIP and helps address remaining persistent vaccine type pneumococcal disease in the population of adults age 65 years or older, which causes thousands of pneumococcal pneumonia cases every year in the United States. Direct vaccination remains the best available tool to help prevent against pneumococcal disease and the revised recommendation emphasizes the importance of the health care professional and patient relationship in shared decision making regarding vaccination," said Luis Jodar, Pfizer Vaccines, Chief Medical and Scientific Affairs Officer at Pfizer.

16:00 EDT Verrica Parmaceuticals Inc trading halted, news pending

15:51 EDT Magellan Health up 5% after WSJ says Centerbridge in exclusive takeover talks

15:16 EDT QEP Resources trading resumes

15:10 EDT QEP Resources trading halted, volatility trading pause

14:56 EDT Geo Group sees no impact on recently extended credit facility from BofA decision - Geo Group (GEO) issued comments on Bank of America's (BAC) decision to no longer extend financing to correctional and rehabilitation services providers. Geo said it expects there to be no impact to its Senior Revolving Credit Facility, which was recently extended. The maturity for the amended Revolver was extended to May 17, 2024. The borrowing capacity under the amended Revolver remains at $900M, and its pricing remains unchanged currently bearing interest at LIBOR plus 2.25%. George Zoley, Geo's Chairman of the Board, CEO and Founder, said: "For over thirty years, we have provided high-quality services to the federal government under both Democrat and Republican administrations. To be clear, The GEO Group has never managed any facilities that house unaccompanied minors, nor have we ever managed border patrol holding facilities. The Processing Centers we manage on behalf of U.S. Immigration and Customs Enforcement are not overcrowded and comply with performance-based standards, which were first established under President Barack Obama's administration. These modern Processing Centers provide safe and humane residential care, high quality medical services, and enhanced amenities including artificial turf soccer fields, flat screen TVs in living areas, indoor and outdoor recreation, classrooms, multipurpose rooms, and libraries."

14:04 EDT Vuzix gets follow on development commitment from global aerospace firm - Vuzix corporation announced it has received an additional follow-on development commitment from a global Tier-1 aerospace firm to build a customized commercial avionics waveguide-based head mounted display system. "We are very pleased with the progress we continue to make with this customer as we jointly work together on a significant production opportunity in the commercial avionics space," said Paul Travers, President and CEO of Vuzix. "OEM custom waveguide-based development and production projects such as this represent a highly profitable vehicle for leveraging our extensive optical expertise and IP and we look forward to announcing further developments with this firm and others going forward."

13:33 EDT Regeneron, Sanofi announce FDA approval for Dupixent - Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the U.S. Food and Drug Administration has approved Dupixent for use with other medicines to treat chronic rhinosinusitis with nasal polyposis in adults whose disease is not controlled. CRSwNP can be a debilitating condition, with many patients opting for systemic steroids or nasal surgery, which often cannot control this disease. Moreover, CRSwNP often occurs in combination with severe asthma. The FDA evaluated the CRSwNP Dupixent application under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. Dupixent is a fully-human monoclonal antibody that inhibits the signaling of interleukin-4 and interleukin-13, two proteins that play a central role in type 2 inflammation. Data from Dupixent clinical trials have shown that inhibiting IL-4 and IL-13 helps address the type 2 inflammation that plays a major role in CRSwNP, asthma and atopic dermatitis. The FDA approval is based on two pivotal trials that are part of the Phase 3 LIBERTY clinical trial program. These trials evaluated Dupixent 300 mg every two weeks with standard-of-care mometasone furoate nasal spray compared to placebo injection plus MFNS. In these trials, Dupixent significantly improved key disease measures and met all primary and secondary endpoints. At 24 weeks, patients treated with Dupixent achieved statistically significant improvements in all primary and secondary endpoints, including:Co-primary endpoints: 57% and 51% improvement in their nasal congestion/obstruction severity compared to a 19% and 15% improvement with placebo in SINUS-24 and SINUS-52, respectively. 33% and 27% reduction in their nasal polyps score compared to a 7% and 4% increase with placebo in SINUS-24 and SINUS-52, respectively. Secondary endpoints: 42% and 27% improvement in sinus opacification compared to 4% and 0% with placebo in SINUS-24 and SINUS-52, respectively. 52% and 45% improvement in loss of smell compared to a 12% and 10% improvement for placebo in SINUS-24 and SINUS-52, respectively. In a pre-specified pooled analysis of the two trials up to 52 weeks, Dupixent treatment resulted in a significant reduction of systemic corticosteroid use and the need for sino-nasal surgery compared to placebo.

13:08 EDT Cherokee Global Brands to change name to APEX Global Brands - Cherokee Global Brands (CHKE) announced that it will be changing its name to APEX Global Brands (APEX) to reflect the company's expanded brand portfolio, marketing and design services, effective June 27, 2019. Cherokee Global Brands will officially become APEX Global Brands on Thursday, June 27, 2019. On that date, the company's common stock will trade on the Nasdaq Capital Markets under the ticker "APEX," previously "CHKE". In addition to a name and ticker change, the company's corporate rebranding efforts will include an updated website and a revised communications offering to promote APEX's unique platform of capabilities.

13:02 EDT Bayer treatment of Fontan-palliated patients granted orphan status - Bayer's treatment of Fontan-palliated patients was granted orphan status by the FDA, according to a post to the agency's website. Reference Link

12:37 EDT Bayer retains John Beisner to advise on glyphosate litigations

12:30 EDT Kretzmer & Associates reports 8.22% passive stake in Enlivex Therapeutics - In a regulatory filing, Kretzmer & Associates disclosed an 8.22% stake in Enlivex Therapeutics, which represents about 830,000 shares. The filing does not allow for activism.

12:00 EDT Care.com falls -17.1% - Care.com is down -17.1%, or -$2.42 to $11.68.

12:00 EDT Ensco Rowan rises 11.6% - Ensco Rowan is up 11.6%, or 89c to $8.49.

12:00 EDT Aerohive rises 39.0% - Aerohive is up 39.0%, or $1.25 to $4.43.

11:40 EDT Gilead unit Asegua and Louisiana team to announce Hep C treatment pay plan - Governor John Bel Edwards joined Secretary Rebekah Gee of the Louisiana Department of Health, Secretary James LeBlanc of the Louisiana Department of Corrections, and Asegua Therapeutica, a wholly-owned subsidiary of Gilead Science, to announce a deal that will allow the implementation of an innovative payment model for hepatitis C treatment, part of Louisiana's plan to eliminate the disease. "This new model has the potential to save many lives and improve the health of our citizens. It is an important day for our state, for our partner Asegua Therapeutics, for providers, but most importantly for the patients and their families who will benefit from treatment," said Governor Edwards. "Asegua was willing to come to the table to work with us to help Louisiana residents and we are pleased to initiate this five year partnership. Ultimately, our goal is to eliminate this disease in Louisiana, and we have taken a big step forward in that effort."

11:21 EDT Insmed reports underwriters exercised options to purchase additional shares - In a regulatory filing earlier, Insmed reported that, as previously announced, the company and William Lewis, Chairman and CEO, referred to as the "selling shareholder", entered into an underwriting agreement, dated May 21, with Morgan Stanley, SVB Leerink and Goldman Sachs as managers of the underwriters, pursuant to which the company agreed to sell to the underwriters, and the underwriters agreed to purchase from the company, 9,615,385 shares of common stock. The company also granted the underwriters an option to purchase up to an additional 1,042,307 shares of common stock and Lewis granted the underwriters an option to purchase up to 400,000 shares of common stock. The offering of the company firm shares pursuant to the underwriting agreement closed on May 24 and on June 20 the underwriters exercised their options to purchase all of the additional shares, the filing stated. The net proceeds to the company from the sale of the additional company shares, after deducting underwriting discounts and commissions but before expenses, are expected to be approximately $25.6M. "The company will not receive any proceeds from the sale of the selling shareholder shares," the filing said.

11:01 EDT Avnet promotes Jessica Daughetee to Chief Marketing Officer - Avnet announced the internal promotion of Jessica Daughetee to Chief Marketing Officer, reporting to MaryAnn Miller, chief administrative officer. Daughetee most recently served as vice president of global content, marketing and media.

10:16 EDT Boston Scientific says plans to launch approximately 75 new products by 2022

10:01 EDT Accenture Federal Services wins position on IAAI contract from Dept. of HHS - Accenture has been selected to provide intelligent automation / artificial intelligence services to the U.S. Department of Health and Human Services Program Support Center. A five-year indefinite delivery / indefinite quantity contract valued at $49M, the IAAI contract will provide the PSC with a range of next-generation technologies, enabling the Department to transform business processes and enhance mission delivery in the federal government. Through the contract, Accenture Federal Services will compete for task orders for the piloting, testing and implementation of advanced technologies such as AI, machine learning, natural language processing and robotic process automation.

10:00 EDT Arcus Biosciences falls -9.6% - Arcus Biosciences is down -9.6%, or -91c to $8.56.

10:00 EDT Synnex rises 7.1% - Synnex is up 7.1%, or $6.51 to $98.53.

10:00 EDT Aerohive rises 40.3% - Aerohive is up 40.3%, or $1.28 to $4.47.

09:47 EDT Britannia Bulk falls -7.3% - Britannia Bulk is down -7.3%, or -49c to $6.22.

09:47 EDT Care.com falls -16.3% - Care.com is down -16.3%, or -$2.30 to $11.79.

09:47 EDT UniFirst rises 8.8% - UniFirst is up 8.8%, or $14.60 to $181.19.

09:33 EDT Tucows mentioned cautiously at Kerrisdale Capital

09:20 EDT Elbit Systems receives $30M in patent infringement litigation case - Elbit Systems announced that the Court of Appeals for the Federal Circuit in Washington, DC ruled completely in Elbit Systems' favor against Hughes Network Systems for infringing an Elbit Systems patent relating to high-speed satellite communications. The Court of Appeals' judgment affirmed the judgment of the District Court for the Eastern District of Texas, which had also ruled in Elbit Systems' favor. The amount of damages awarded to Elbit Systems, and interest to which Elbit Systems is entitled - including a $21.1M jury award, pre-verdict and post-verdict royalties and costs - totals approximately $30M. The trial court has yet to rule on the extent to which it will grant Elbit Systems' request for $13.8M in attorneys' fees due to Hughes' "bad faith litigation misconduct," which the Court found to be "exceptional." Any eventual award of attorney's fees would be subject to a separate potential appeal by Hughes.

09:15 EDT OncoCyte to require additional time for CLIA Validation study of DetermaVu - OncoCyte Corporation provided a mid-year update and announced that the Company will require additional time to complete its ongoing CLIA Validation study of DetermaVu, its liquid biopsy test for lung cancer. In the CLIA Validation Study, started in late April, OncoCyte is assaying approximately 120 samples previously tested in its R&D Validation study, with the goal of demonstrating that the same results can be obtained in the Company's CLIA-validated laboratory. To complete a technology transfer from an R&D setting to full commercial production in a CLIA lab typically requires several components of workflow validation, including sample prep and sample extraction kits that can ultimately be automated. Due to ongoing efforts to create consistency in this process and to ensure the CLIA assay provides the most consistent, sensitive results for patients the company will continue its development work before releasing the final data.

09:13 EDT GameStop announces agreement with 'Street Fighter' gamer Justin Wong - GameStop announced an agreement with Justin Wong, ranked No. 1 in countless Street Fighter gaming tournaments, to create a comprehensive gaming clinic coming this fall for GameStop's customers. Wong currently holds the world record for the longest fighting game winning streak, with 300 wins, and is well-known for his ability to comeback against impossible odds - also known as "The Wong Factor."

09:10 EDT Y-mAbs Therapeutics to present data at 2019 SIOP - Y-mAbs Therapeutics announced the acceptance of two oral presentations and five poster presentations at the International Society of Pediatric Oncology Annual Congress. The abstracts include the following presentation of omburtamab, one of the Company's lead product candidates, which is currently being evaluated for the treatment of patients with CNS/Leptomeningeal metastasis from neuroblastoma, diffuse intrinsic pontine glioma, and desmoplastic small round cell tumors: "A curative approach to central nervous system metastatis of neuroblastoma," submitted by Memorial Sloan Kettering Cancer Center in New York: The abstracts also include the following presentations of naxitamab, the Company's second lead product candidate, which is currently being evaluated for the treatment of pediatric patients with relapsed or refractory high-risk neuroblastoma, osteosarcoma and other GD2-positive tumors: "Naxitamab-based chemoimmunotherapy for resistant high-risk neuroblastoma: Preliminary results of "HITS" pilot/phase II study," submitted by Memorial Sloan Kettering Cancer Center in New York. "Preliminary tolerability assessment of naxitamab therapy in a phase 2 osteosarcoma trial," submitted by Memorial Sloan Kettering Cancer Center in New York. "High-dose naxitamab plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor for consolidating greater than or equal to2nd complete remission of high-risk neuroblastoma," submitted by Memorial Sloan Kettering Cancer Center in New York. "High-dose naxitamab plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor for neuroblastoma: Outpatient treatent low immunogenicity, and major responses in a Phase II trial," submitted by Memorial Sloan Kettering Cancer Center in New York. "High-dose naxitamab plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor for relapsed neuroblastoma resistant to salvage therapy: A Phase II trial," submitted by Memorial Sloan Kettering Cancer Center in New York. "High-dose naxitamab plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor for high-risk neuroblastoma: Efficacy against histologically-evident primary refractory metastases in bone marrow," submitted by Memorial Sloan Kettering Cancer Center in New York.

09:06 EDT Canopy Growth acquires KeyLeaf Life Sciences - Canopy Growth has completed a transaction to acquire Saskatoon-based bio-product extractor KeyLeaf Life Sciences, related entities, and intellectual property. Canopy Growth assumed control of KeyLeaf for accounting purposes in November 2018. The company is acquiring a large-scale Canadian extraction facility as well as an extraction-related facility in the U.S. to support its U.S. CBD expansion. KeyLeaf's chemists, engineers, and operators will remain within the organization. Canopy Growth's Saskatchewan facility, which is currently in the Health Canada licensing process, is anticipated to process up to 5,000 kg of input materials daily when operational. Canopy Growth intends to leverage this facility, along with other owned and partner extraction options, to process its over 5,000 acres of Canadian CBD hemp production, over 160 acres of outdoor cannabis production, as well as any extraction materials outputted from its over 4 million square feet of greenhouse growing operations. Additionally, the acquisition includes KeyLeaf's ingredient science and innovation industrial scale facility in Batavia, Illinois. The Batavia facility focuses on short path distillation and the concentration of key compounds, ensuring that the output is free of impurities in products intended for consumption and currently holds several certifications.

09:02 EDT UPS opens Indianapolis 'super hub' for package sortation, distribution - UPS announced the official opening of its new 893,000 square foot Plainfield, Indiana package sortation and distribution center. The Indianapolis-area facility initially started processing packages in 2017 during the busy holiday season while construction of the new "super hub" was still underway. Now operating at full capacity, customers are receiving all of the benefits from the facility's increased speed, efficiency and dynamic routing technology.

08:58 EDT Knight Therapeutics files new drug submission for Ibsrela in Canada - Knight Therapeutics announced that Knight's New Drug Submission for Ibsrela has been accepted for review by Health Canada for the treatment of irritable bowel syndrome with constipation. Knight and Ardelyx entered into a license agreement in March 2018 granting Knight the exclusive right to commercialize tenapanor in Canada.

08:54 EDT Acasti sees material uncertainty about 'ability to continue as going concern' - The company said, "As at March 31, 2019, Acasti had total cash of $34.4 million, an increase of $26.2 million over last year, due to net proceeds from the May and October public offerings, partially offset by the cash used in operating activities. Acasti believes that the current cash on hand will fully fund the Company's operations beyond the completion of the Phase 3 clinical trials for CaPre. Acasti will need to raise additional capital in the future to complete the funding of its NDA preparations and US commercial launch activities, which could be in the form of dilutive and/or non-dilutive financings. If Acasti does not raise additional funds, it may not be able to realize its assets and discharge its liabilities in the normal course of business. As a result, there exists a material uncertainty about the Acasti's ability to continue as a going concern."

08:50 EDT Acasti Pharma 'on track' to report topline results for TRILOGY 1 in December - Jan D'Alvise, president and CEO of Acasti Pharma, commented, "Fiscal 2019 was an eventful year for the Company as we achieved several key milestones related to our ongoing Phase 3 clinical trials, which remain on schedule and within budget. We recently announced that we had achieved 100% patient randomization in both TRILOGY clinical studies, and more than 60% of patients have now completed the trial. As a result, we remain on track to report topline results for our primary endpoint of lowering triglycerides for TRILOGY 1 in December 2019, and for TRILOGY 2 in January 2020. In addition to our preliminary topline data, we will seek to present the full data set, which will include results for our key secondary and exploratory endpoints of interest such as LDL-C, VLDL, HDL-C and HbA1c, as a late breaker presentation at the American College of Cardiology meeting at the end of March 2020."

08:46 EDT CareDx receives U.S. patent for transplants - CareDx announced the addition of a new transplant patent to the company's intellectual property portfolio. Title: Non-invasive diagnosis of graft rejection in organ transplant patients. "CareDx continues to collaborate with a wide range of leading researchers in transplantation to bring innovation and advance the science in the field," said Peter Maag, CareDx Chief Executive Officer. "This latest patent extends our position as the leading provider of genomics-based information in transplantation. Our strong leadership position allows us to focus on our commitment to improve outcomes for transplant patients."

08:43 EDT Barrick Gold 'continues to believe' proposal reflects 'the fair value' of Acacia - Barrick Gold Corporation provides the following response to the announcement made by Acacia Mining. The company said, "Barrick continues to believe that the terms of its Proposal reflect the fair value of Acacia, not taking into account any further discount which could be applied to reflect the significant risk inherent in the Acacia business and remaining uncertainties of any settlement with the Government of Tanzania. In the absence of a take-private transaction, Barrick does not consider there is any credible alternative solution which will preserve, to the extent possible, value for all stakeholders. Barrick has considered the statements made in the Acacia Announcement and has concluded that the Acacia Announcement contains no information of which Barrick was not already aware. Barrick therefore remains firmly of the view that certain assumptions made by Acacia in relation to its mine plans are not appropriately risked or supportable and that adjustments should be made. Whilst Barrick does not consider it necessary to respond to each and every statement made by Acacia in its announcement, it wishes to underline the following key points: Barrick notes the reference to Canadian Institute of Mining, Metallurgy and Petroleum Definition Standards in the Acacia Announcement, and fully endorses the Acacia 2018 Mineral Resources and Mineral Reserves Statement, which included the update to the classification of previously reported Indicated Mineral Resources to the Inferred Resources category at Bulyanhulu to reflect the wide spaced drill data for the Deep West zone of the orebody. Barrick maintains that the inclusion of the Deep West Inferred Mineral Resources inventory on an equal footing to the Measured and Indicated Mineral Resources within the Optimisation Study of Bulyanhulu materially overstates the value of the mine, is inconsistent with acceptable industry practice and not in compliance with the CIM Standards...Barrick also notes that Acacia's rebuttal of Barrick's views on conversion and dilution rates by reference to the 96.5% reconciliation factor of gold mined versus the historical Mineral Resource Model over the life of mine is misleading. The 96.5% historic reconciliation is reflective of Mineral Resources supported by 25m spaced drill sample data and development face sample data and thus should not be considered applicable to the expected conversion of Deep West Inferred Mineral Resources, which are based upon on an average of 200m spaced drill data. Barrick is content with the utilization of the Measured and Indicated Resources by Acacia in its Optimisation Study, but not the Inferred Resources in the Deep West. Furthermore, Barrick is of the opinion that the Deep West Inferred Mineral Resources still require full geotechnical stress modelling and therefore any current mine plans should acknowledge this related risk... Barrick intends to continue to engage on these points, and on the merits of its proposal, with shareholders, Acacia's Board of Directors, its management and other stakeholders."

08:39 EDT Beyond Meat announces nationwide retail launch of Beyond Beef - Beyond Meat announced its latest groundbreaking product, Beyond Beef, will start to hit retail shelves nationwide later this week. Beyond Beef is a new plant-based ground meat made without GMOs, soy or gluten designed to deliver the same versatility, meaty texture and juiciness of traditional ground beef.

08:37 EDT Corteva names Marcos Lutz to Board of Directors - Corteva announced that Marcos Lutz, CEO of Cosan Limited, has been elected to Corteva's Board of Directors, effective June 25. He will serve on the Audit and People and Compensation committees of the Board.

08:36 EDT Ziopharm completes enrollment of controlled IL-12 plus Opdivo Phase 1 trial - Ziopharm Oncology announced completion of enrollment of the third cohort of a phase 1 clinical trial evaluating Controlled IL-12, in combination with the PD-1 inhibitor OPDIVO for the treatment of recurrent or progressive glioblastoma multiforme in adults. Investigators from this multi-center trial, conducted at Northwestern University in Chicago, Brigham and Women's Hospital in Boston, and The University of Texas MD Anderson Cancer Center in Houston, have indicated interest in expanding the study and the Company now expects to enroll additional patients at the highest dosing level, subject to final agreement by the Data and Safety Monitoring Board. Ziopharm's Controlled IL-12 platform is an investigational gene therapy designed to induce and control the production of human interleukin 12 a master-regulator of the immune system. In the setting of rGBM, the Company is leveraging the anti-tumor effects for Controlled IL-12 as monotherapy by combining with PD-1 inhibitors. Previously reported data from serial biopsies in patients with rGBM revealed that Controlled IL-12 results in sustained influx of T cells and upregulation of PD-1 expression, providing a compelling rationale for this combination. Initial phase 1 data from this trial were presented at the American Society for Clinical Oncology Annual Meeting on June 2, 2019, showing Controlled IL-12 can be combined with PD-1 inhibitor OPDIVO and the initial data were consistent with immune mediated anti-tumor effects with a favorable safety profile. Ziopharm anticipates reporting on further data from this combination trial at medical meetings later this year and into 2020.

08:36 EDT Ascena Retail reduces size of board to 10 members from 12 members - Ascena Retail announced the resignation of two of its board members, Steven Kirshenbaum and Marc Lasry, effective June 30. The board has approved a reduction in the size of the Board from 12 to 10 directors, effective as of that date.

08:34 EDT Veru announces completion of pre-NDA meeting with FDA for TADFIN - Veru announced that the Company concluded its pre-New Drug Application meetings with the U.S. Food and Drug Administration for TADFIN formulation for the treatment of benign prostatic hyperplasia. The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical, non-clinical, and chemistry, manufacturing and controls requirements for the Company's NDA submission utilizing the FDA expedited 505(b)(2) regulatory pathway. Veru submitted a pre-NDA briefing document to the FDA that outlined the Company's preliminary data package being prepared for the NDA submission, including bioequivalence and bioavailability clinical study results, CMC and other regulatory elements for a 505(b)(2) submission. The Company believes it has reached agreement with FDA on the regulatory data package requirements that will be sufficient for submission. FDA requested that the company submit 12-month stability data on manufacturing batches to support the expiry date of TADFIN at the time of the NDA submission. Tadalafil is currently approved for treatment of BPH and erectile dysfunction and finasteride is currently approved for treatment BPH and male pattern hair loss. The co-administration of tadalafil and finasteride has been shown to be more effective for the treatment of BPH than by finasteride alone.

08:34 EDT Corteva announces common stock dividend of 13c per share - The company's Board of Directors authorized a common stock dividend of 13c per share, payable September 13 to the company's shareholders of record on July 31. This marks the first cash dividend to be issued by the company since its spinoff from DowDuPont on June 1.

08:32 EDT Booking Holdings announces leadership changes at Booking.com - Booking Holdings announced that Gillian Tans has been appointed to the role of Chairwoman of Booking.com and Glenn Fogel, CEO of Booking Holdings, will take on an expanded role that includes CEO of Booking.com, effective immediately. Tans was appointed CEO of Booking.com in 2016. Prior to that, Tans served as Booking.com's President and COO, a role she was appointed to in 2011, as well as other positions at the helm of Booking.com's global sales, operations, IT, content and customer care departments. Fogel previously served as head of worldwide strategy and planning, a position he held from November 2010 to December 2016. He joined Booking Holdings in February 2000.

08:31 EDT AMSC announces contract modification of REG agreement with DHS - AMSC announced that the Department of Homeland Security has signed the modification of its Resilient Electric Grid agreement with AMSC. The contract modification with DHS approves the scope of AMSC's REG project with Commonwealth Edison and will enable AMSC to recover a portion of the project cost. Chicago's REG project is funded in part by the DHS Science and Technology Directorate initiative to secure the nation's electric grid against extreme weather or other catastrophic events. The REG system uses AMSC's high temperature superconductor technology and, under the terms of the agreement between AMSC and ComEd, will link existing electric power infrastructure within the City of Chicago. The REG system is expected to strengthen Chicago's electric grid and to enhance its load serving capacity, resiliency and reliability. AMSC expects that the engineering work for the REG project in Chicago will begin in calendar year 2019, the REG project hardware will be delivered in 2020 and the REG system will be operational in 2021.

08:26 EDT Nuance signs strategic partnership with research institution Mila - Nuance Communications announced it has signed a partnership with Mila, an academic research institution dedicated to advancing machine learning with an intensive focus on deep learning related to language and image processing. This expanded partnership enables Nuance and Mila to collaborate on research, advance cutting-edge work in machine learning, and meaningfully enhance AI applications. As part of the partnership, Nuance will staff an AI lab at Mila's Montreal-based headquarters, where researchers will partner with Mila interns on projects, and participate in joint research, publications, and knowledge-sharing talks

08:23 EDT Valley National sees Oritani transaction accretive to earnings in 2020 - The company said, "Under the terms of the definitive agreement signed by the companies, each Oritani shareholder will receive 1.60 shares of Valley common stock for each share of Oritani common stock they own. Oritani's normal quarterly cash dividend policy for the period ended June 30, 2019 will not be impacted by this transaction. However, any subsequent quarterly dividends declared by Oritani will be limited to the current rate paid by Valley, exchange adjusted to 18c per common until the close of the merger. The following are selected terms and metrics associated with the transaction based upon current projections, including the proposed refinancing of FHLB borrowings: Purchase price represents a fixed 1.60x for 1 exchange ratio; Total transaction value of approximately $740M; Price to 2020 Fully Synergized EPS of 9.8x; Price to tangible book value of 1.4x; Tangible book value accretion of 0.0%; Anticipated to be accretive to earnings in 2020, including FHLB restructuring."

08:19 EDT Valley National to acquire Oritani Financial in transaction valued at $740M - Valley National Bancorp (VLY) announced that it is doubling its market share in demographically attractive Bergen County and enhancing its presence in Hudson County by acquiring Oritani Financial (ORIT). The companies have entered into a merger agreement in which the common shareholders of Oritani will receive 1.60 shares of Valley common stock for each Oritani share they own. The transaction is valued at an estimated $740M, based on Valley's closing stock price on June 25, 2019. Valley, and its wholly-owned subsidiary, Valley National Bank, has approximately $32.5B in assets, $25.4B in loans, $24.9B in deposits and more than 200 branches in New Jersey, New York, Florida and Alabama. Oritani, and its wholly-owned subsidiary, Oritani Bank has approximately $4.1B in assets, $3.5B in loans, $2.9B in deposits, and maintains a branch network of 26 offices. The acquisition represents a significant addition to Valley's New Jersey franchise, and will meaningfully enhance its presence in the densely populated and affluent Bergen County market. The acquisition will also bolster capital, providing greater balance sheet optionality and the acceleration of previously disclosed strategic initiatives. The combined company at close is expected to have approximately $38B in assets, $30B in loans, $29B in deposits, and 245 branches across New Jersey, New York, Florida, and Alabama. The Boards of Directors of both companies, after extensive review and due diligence, unanimously approved the transaction. The acquisition is expected to close late in the fourth quarter of 2019, subject to standard regulatory approvals, shareholder approvals from Valley and Oritani, as well as other customary conditions. In conjunction with the closing of this transaction, Valley is planning on restructuring approximately $635M of higher cost FHLB borrowings. Valley anticipates the result of the merger, combined with debt restructuring will be immediately neutral to slightly accretive to earnings per share and tangible book value while increasing Tier 1 Common Equity by over 50 basis points.

08:16 EDT Gemphire announces data from FPLD Phase 2a proof-of-concept NAFLD/NASH trial - Gemphire Therapeutics announced top-line results based upon the Company's preliminary review of the limited top-line dataset from the investigator-led Phase 2a study of adult FPLD patients evaluating efficacy, safety, and tolerability of oral gemcabene. Five FPLD patients were enrolled in this open-label study with two patients having lamin Agene mutations and three patients with unknown causes of the condition. Average baseline serum triglyceride levels were 587.3 mg/dL and average MRI-PDFF liver fat fraction was 14.1%. All patients received a 300 mg/day dose of gemcabene for the first 12 weeks, with randomization to either the same dose or a higher dose of 600 mg/day for the subsequent 12 weeks. Gemcabene treatment resulted in a median change in serum triglycerides of -19.6% for the five patients at twelve weeks. The range of TG responses was +40.4 % to -52.9%, with three patients showing decreases. Secondary endpoints included measurement of liver fat fraction by MRI-PDFF which showed reduction in 2 of the 3 responding patients. Four patients completed treatment and a fifth one discontinued at 22 weeks. Gemcabene appeared to be generally safe and well-tolerated in these five patients. There was one serious adverse event of benign paroxysmal positional vertigo, considered unrelated to gemcabene. In the Company's INDIGO-1 trial, in patients with severe hypertriglyceridemia, gemcabene lowered median serum TGs by -47%. In the COBALT-1 familial hypercholesterolemia trial, gemcabene lowered LDL-C by a mean of -25% to -30% in a population with an average baseline LDL-C of 351 mg/dL and already on background LDL-lowering therapies. Gemcabene has been tested as monotherapy and in combination with statins and other drugs in more than 1,100 subjects, across 25 Phase 1 and Phase 2 clinical trials and has demonstrated promising evidence of efficacy, safety and tolerability. As previously announced, Gemphire continues to work with Ladenburg Thalmann & Co., Inc. to pursue strategic alternatives. In addition, the Company is continuing to make progress with the preclinical studies requested by the FDA to address the partial clinical hold on gemcabene.

08:11 EDT BlackBerry expands relationship with LG Electronics - BlackBerry announced that it is expanding its partnership with LG Electronics to accelerate the deployment of connected and autonomous vehicle technology for automotive OEMs and suppliers around the world. As part of the agreement, LG Electronics will use a range of BlackBerry QNX software and services to build next generation digital consolidated cockpits, including infotainment systems, digital instrument clusters, and telematics systems for multiple OEMs.

08:09 EDT Evine Live to focus on execution of interactive media growth strategy - Evine Live announced the completion of its previously announced review of strategic alternatives. After careful consideration of a broad range of strategic alternatives in consultation with its financial and legal advisors, the board of directors has determined the interests of the Company's shareholders are best served by focusing on the execution of the Company's new interactive media growth strategy that was previously announced on May 29, 2019.

08:02 EDT Golden Star Resources COO Daniel Owiredu to step down, Graham Crew to succeed - Golden Star Resources announces that Daniel Owiredu will be stepping out of the role of Executive Vice President and COO of Golden Star with effect from July 8, and will be replaced in that role by Graham Crew. During the transition period until December 31, Daniel will take on the role of President of the company. As of January 1, 2020, Owiredu will step down as President and be appointed as Chairman of the Boards of Directors of the company's subsidiaries, Golden Star Limited and Golden Star Limited. Crew most recently was General Manager Mining for Barminco Limited, a global underground mining services company.

07:37 EDT Novocure announces publication of IQWiG rapid report for Optune - Novocure announced that the German Institute for Quality and Efficiency in Healthcare, or IQWiG, has published its rapid report concluding that, based on a review of Novocure's EF-14 phase 3 pivotal trial, patients with newly diagnosed glioblastoma, or GBM, lived longer when treated with Optune in addition to standard chemotherapy, without affecting quality of life. This conclusion is an important step in Novocure's process to secure national reimbursement for Optune in Germany. In November 2018, the German Federal Joint Committee, or G-BA, commissioned IQWiG to prepare its report, which IQWiG did in an accelerated procedure, known as a rapid report. IQWiG sent this rapid report to the G-BA in May. G-BA should now continue the process toward a national reimbursement decision for Optune in Germany. According to its published timeline, a directive is expected no later than October 2020. As the review process advances in Germany, Novocure will continue to bill payers for individual cases. Each case is evaluated individually on its merits and under the payer's specific rules for such cases. IQWiG's evaluation was based on the EF-14 phase 3 pivotal trial data published in JAMA in December 2017. EF-14 demonstrated that patients with newly diagnosed GBM who added Optune to standard chemotherapy, temozolomide, had a greater opportunity to live longer than those who used chemotherapy alone. Patients treated with Optune plus temozolomide experienced overall survival of 20.9 months versus 16 months for patients treated with temozolomide alone. Two and five-year survival rates were better with Optune with 13% of patients treated with Optune plus chemotherapy alive at five years versus 5% of patients treated with chemotherapy alone. Patients treated with Optune were also able to maintain their mental, emotional and physical well-being longer than those on chemotherapy alone.

07:33 EDT Intrexon doses first patient in Phase 1/1b study of Acute Myeloid Leukemia drug - Intrexon's wholly-owned subsidiary Precigen, specializing in the development of gene and cellular therapies, announced that the first patient has been dosed with PRGN-3006, a first-in-class investigational therapy using Precigen's non-viral UltraCAR-T therapeutic platform. PRGN-3006 UltraCAR-T is an autologous chimeric antigen receptor T cell therapy under investigation for the treatment of patients with relapsed or refractory acute myeloid leukemia or higher risk myelodysplastic syndrome. PRGN-3006 utilizes Precigen's UltraCAR-T therapeutic platform, which eliminates ex vivo expansion and reduces manufacturing time to fewer than two days following non-viral gene transfer at the cancer center. The PRGN-3006 UltraCAR-T clinical study is a single center, nonrandomized, investigator-initiated Phase 1/1b safety and tolerability study. The safety and tolerability of PRGN-3006 UltraCAR-T will be assessed following intravenous administration of escalating doses in patients with relapsed or refractory AML or higher risk MDS.

07:32 EDT Primoris announces heavy civil award valued over $24M - Primoris Services Corporation announced a new heavy civil award valued over $24M. The contract was secured by Primoris Heavy Civil, part of the Civil segment. The project was awarded by the Texas Department of Transportation and is located in Travis County, Texas. The project involves the construction of a diverging diamond intersection to alleviate an existing traffic bottleneck. Work also includes widening and extending a frontage road, adding a bypass lane, reconstructing two entrance/exit ramps, and improving bicycle and pedestrian accommodations. Construction is scheduled to begin in the third quarter of 2019, and completion is anticipated for the first quarter of 2021.

07:13 EDT IZEA announces Instagram Stories support in IZEAx Unity Suite - IZEA Worldwide (IZEA) announced the release of Instagram Stories (FB) in IZEAx 3.0 Unity Suite. Marketers can now add a series of Instagram Story frames to any influencer marketing campaign within Unity Workflow. Both photo and video Stories can be created either as standalone sponsorships, or as part of a larger sponsored content initiative that includes other social channels such as blogs, Twitter (TWTR), Facebook, and YouTube (GOOG, GOOGL). Campaigns can be multi-channel in nature, with any number of posts on any number of channels over any period of time.

07:10 EDT Cara Therapeutics initiates Phase 2 trial of Oral KORSUVA - Cara Therapeutics announced the initiation of a Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with hepatic impairment due to primary biliary cholangitis. Pruritus is a common symptom of cholestatic liver diseases with a prevalence of up to 70 percent in patients with PBC. The Phase 2 multicenter, randomized, double-blind, placebo-controlled 16-week trial is designed to evaluate the safety and efficacy of 1 mg tablet of Oral KORSUVA taken twice daily versus placebo in approximately 60 patients with PBC and moderate-to-severe pruritus. The primary efficacy endpoint is the change from baseline in the weekly mean of the daily 24-hour Worst Itch Numeric Rating Scale score at Week 16 of the treatment period. Secondary endpoints include change from baseline in itch-related quality of life scores at the end of Week 16 as assessed by the total Skindex-10 and 5-D itch scales, as well as the assessment of proportion of patients achieving an improvement from baseline of greater than or equal to3 points with respect to the weekly mean of the daily 24-hour WI-NRS score at week 16. The dose of Oral KORSUVA in the Phase 2 trial is based on comparison to the exposure levels achieved with 0.5 mcg/kg dose of I.V. KORSUVA that exhibited statistically significant and clinically meaningful reduction in itch intensity in hemodialysis patients with moderate-to-severe pruritus in the Phase 2 and 3 trials.

07:08 EDT General Mills expects to 'generate top-tier total holder returns over long term' - General Mills is pursuing its Consumer First strategy and executing against its global growth framework to drive consistent topline growth: 1) competing effectively through strong innovation, effective consumer marketing, and excellent in-store execution; 2) accelerating growth on its four differential growth platforms including Haagen-Dazs ice cream, snack bars, Old El Paso Mexican food, and its portfolio of natural and organic food brands; and 3) reshaping its portfolio through growth-enhancing acquisitions and divestitures, including the acquisition of Blue Buffalo, the leading brand in the fast-growing wholesome natural pet food category in the U.S. By combining consistent topline growth, margin expansion, and disciplined cash conversion and cash returns, General Mills expects to generate top-tier total shareholder returns over the long term.

07:05 EDT Plug Power 'on track to set a record quarter' in Q2 for units produced, deployed - Plug Power highlights record numbers as the close of the 2019 second quarter approaches. The Company remains on track to set a record quarter in Q2 for units produced and deployed in any second quarter in its history. In the second quarter 2019, Plug Power is on track to deploy approximately 2,000 fuel cell units to a variety of new customers and for expansions of many existing customer programs. The deployment volumes equate to an approximately 70% increase from the prior year second quarter. "Ongoing commercial traction and growth has led us to this record quarter," said Andy Marsh, CEO of Plug Power. "We continue to further the commercial adoption of hydrogen and fuel cells in material handling applications, Plug Power's core market. Additionally, we've successfully moved the proven technology into adjacent applications with our ProGen fuel cell engine product line, namely on-road with StreetScooter, into small-scale robotics and UAVs through the acquisition of EnergyOr, and into telecommunication back-up and remote village power with global channel partners like Chem."

07:03 EDT Translate Bio announces FDA clearance for SAD Phase 1/2 trial of MRT5201 - Translate Bio announced that it has received clearance from the U.S. Food and Drug Administration to proceed with a single-ascending dose Phase 1/2 clinical trial of MRT5201 in adult patients with ornithine transcarbamylase deficiency. MRT5201 is a first-in-class treatment designed to directly address the underlying cause of OTC deficiency by providing mRNA encoding the fully functional OTC enzyme in patients with the disease. As previously announced, in December 2018, the Company submitted an investigational new drug application for a SAD and multiple-ascending dose Phase 1/2 study of MRT5201, which the FDA placed on clinical hold, pending additional preclinical toxicology data. After discussions with the FDA and after the Company amended the protocol, the FDA has removed the clinical hold and will allow the Company to move forward with a SAD clinical trial. Additional preclinical studies will be required to support future clinical development of MRT5201, including a MAD clinical trial. These additional preclinical studies are currently underway, and the Company plans to submit data from these studies to the FDA in the fourth quarter of 2019.

06:55 EDT Eli Lilly AWARD-11 study of Trulicity meets primary, secondary endpoints - Eli Lilly's trial studying higher investigational doses of Trulicity met its primary efficacy endpoint of superiority, significantly reducing A1C from baseline in people with type 2 diabetes, compared to once-weekly Trulicity 1.5 mg after 36 weeks. The trial also met the secondary efficacy endpoint for superiority on weight reduction. The safety and tolerability profile of the investigational dulaglutide doses was consistent with the known profile of Trulicity 1.5 mg. AWARD-11, a phase 3 randomized, double-blind, parallel arm study, evaluated the safety and efficacy of dulaglutide 3.0 mg and 4.5 mg doses in 1,842 participants with type 2 diabetes. The AWARD-11 trial will continue through 52 weeks to evaluate longer-term safety data and is expected to complete in late 2019. Lilly plans to submit to regulatory authorities by late 2019 and will share detailed results at a future date.

06:48 EDT CrossAmerica and Applegreen sign site operation agreement in Midwest - CrossAmerica has entered into a definitive agreement with Applegreen for the global roadside convenience retailer to operate 46 company operated retail sites in the U.S. Upper Midwest. As part of this agreement, CrossAmerica will enter into a master fuel supply and master lease agreements with Applegreen. The deal is expected to close in Q3.

06:38 EDT Extreme Networks to acquire Aerohive for $4.45 per share in cash - Extreme Networks (EXTR) and Aerohive (HIVE) announced they have entered into a definitive agreement under which Extreme will acquire all of the outstanding shares of common stock of Aerohive at a price of $4.45 per share in cash, representing an aggregate purchase price of approximately $272M. Accounting for Aerohive's net cash balance of $62M at the end of March, the deal is equivalent to an enterprise value of $210M. The acquisition of Aerohive will add cloud management and edge capabilities to Extreme's portfolio of end-to-end, edge to cloud networking solutions. It will provide a subscription revenue stream and strengthen Extreme's position in wireless LAN at a technology transition to Wi-Fi 6. Extreme expects the acquisition to be accretive to non-GAAP earnings per share starting in FY20. Aerohive has a global footprint of 30,000 cloud wireless LAN customers in verticals including education, healthcare, state and local government, and retail. This acquisition will bring new automation and intelligence capabilities to Extreme's elements portfolio. Extreme expects to gain new SD-WAN capabilities, in all expanding its total addressable market by a total of $1B in a market with a CAGR of 19% through 2022. At a time when many of Extreme's customers and partners are turning toward as-a-service/subscription models to reduce costs and gain efficiencies, Aerohive will expand Extreme's mix of revenues to approximately 30% from subscription recurring revenue. The acquisition is structured as an all-cash tender offer for all outstanding common stock of Aerohive, followed by a merger of a wholly-owned subsidiary of Extreme with and into Aerohive. Under the terms of the merger agreement, Extreme will commence a tender offer to acquire all of the outstanding shares of Aerohive's common stock at a price of $4.45 per share in cash, representing an aggregate purchase price of $272M, plus the assumption of unvested options and restricted stock units. The board of both Extreme and Aerohive have unanimously approved the terms of the merger agreement and the board of Aerohive has resolved to recommend that Aerohive's stockholders accept the offer once it is commenced. The acquisition is not subject to a financing condition and Extreme expects to fund the acquisition from a combination of available cash and committed debt financing. The acquisition is subject to customary conditions, including the tender of the majority of the outstanding shares of Aerohive's common stock and regulatory approvals in the U.S. and Germany. The acquisition is expected to close during Extreme's Q1 of FY20.

06:07 EDT Kaman sells distribution segment to Littlejohn & Co. for $700M - Kaman has entered into a definitive agreement to sell its Distribution segment to affiliates of Littlejohn & Co. for total cash consideration of $700M subject to customary closing conditions and working capital adjustments. The transaction value represents a multiple of 10.4 times trailing twelve-month Segment Adjusted EBITDA for the Distribution segment. Following the completion of the transaction, Kaman will continue to design and manufacture critical components, structures, and systems for commercial and military customers. The Aerospace Segment currently operates out of fourteen facilities around the world with almost 3,000 employees and is expected to generate $730M-$760M of revenue in 2019. Kaman's Distribution Segment has 2,200 employees and generated $1.1B in net revenue in 2018. Kaman expects to receive approximately $600M in net proceeds from the transaction. The company will allocate proceeds to pay down approximately $100M of debt and accelerate internal development efforts. In addition, the company will pursue strategic acquisitions focused on attractive engineered product end markets. The transaction is expected to close in Q3.

06:04 EDT Argo AI to invest $15M into self-driving car research center at CMU - Carnegie Mellon University and Ford-backed Argo AI announced a five-year, $15M sponsored research partnership under which the self-driving technology company will fund research into advanced perception and next-generation decision-making algorithms for autonomous vehicles. Argo AI and Carnegie Mellon will establish the Carnegie Mellon University Argo AI Center for Autonomous Vehicle Research, which will pursue advanced research projects to help overcome hurdles to enabling self-driving vehicles to operate in a wide variety of real-world conditions, such as winter weather or construction zones. "We are thrilled to deepen our partnership with Argo AI to shape the future of self-driving technologies," CMU President Farnam Jahanian said. "This investment allows our researchers to continue to lead at the nexus of technology and society, and to solve society's most pressing problems. Together, Argo AI and CMU will accelerate critical research in autonomous vehicles while building on the momentum of CMU's culture of innovation."

06:03 EDT IHS Markit CFO says 'positioned well' to deliver FY19 financial commitments - "Our business model continues to perform well as we delivered another quarter of diversified revenue growth and strong margin and profit in the quarter," said Lance Uggla, chairman and CEO at IHS Markit. "We delivered a solid first half of the year and are positioned well to deliver upon our full year financial commitments," said Todd Hyatt, CFO at IHS Markit.

05:59 EDT NBCUniversal secures exclusive domestic streaming rights to 'The Office' - NBCUniversal announced Tuesday that it has secured the exclusive domestic streaming rights to "The Office." All nine seasons of this beloved NBC sitcom will be available on the company's soon-to-be-launched streaming service for five years, beginning 2021. "'The Office' has become a staple of pop-culture and is a rare gem whose relevance continues to grow at a time when fans have more entertainment choices than ever before," said Bonnie Hammer, Chairman of NBCUniversal Direct-to-Consumer and Digital Enterprises. "We can't wait to welcome the gang from Dunder Mifflin to NBCUniversal's new streaming service." NBCUniversal's ad-supported streaming service is set to launch in 2020.

05:32 EDT Bombardier awarded 10-year $220M APM operations, maintenance contract in CA - Bombardier Transportation announced that it has signed a new contract with the City and County of San Francisco to provide ten years of operations and maintenance services for the BOMBARDIER INNOVIA APM 100 automated people mover, or APM, system at San Francisco International Airport. The contract is valued at $220M and includes an option for an additional five years.