Stockwinners Market Radar for May 16, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:41 EDT Genuine Parts committed to Essendant deal, claims Staples offer not superior - Genuine Parts Company (GPC) commented on its previously announced definitive merger agreement to combine its S.P. Richards business with Essendant (ESND) in response to the announcement of Staples, Inc.'s conditional, non-binding proposal to acquire Essendant for $11.50 per share in cash. Genuine Parts stated: "As announced on April 12, 2018, GPC entered into a definitive agreement to combine our S.P. Richards business with Essendant. We are confident that combining the best elements of both businesses will create an even stronger company with the ability to capitalize on opportunities to create value for all of our stakeholders. We continue to make progress on our integration planning, and we remain committed to completing this transaction, which is on track to close before the end of 2018. On May 7, 2018, GPC demonstrated its confidence in the upside value creation of this merger by proposing to Essendant enhanced transaction terms under which, in addition to owning 49% of the combined company on a diluted basis, Essendant shareholders would receive a Contingent Value Right for each Essendant share held immediately prior to the closing of the transaction. Through the CVR, GPC would provide Essendant shareholders with a potential cash payment of up to $4.00 per CVR based on how Essendant shares trade during a 20-day measurement period at the later of the end of 2019 or 12 months from the closing of the transaction. The cash payment would be equal to $12.00 minus the greater of the weighted average share price of the combined company during the measurement period or $8.00. We do not believe Staples' conditional, non-binding proposal to acquire Essendant for $11.50 per share in cash to be a superior proposal nor reasonably likely to lead to a superior proposal as defined under the terms of the Merger Agreement. Indeed, given the proposed enhanced terms and the expected financial benefits of more than $75 million in annual run-rate cost synergies and more than $100 million in working capital improvements, we are confident that the merger between S.P. Richards and Essendant delivers superior value to Essendant's shareholders. Based on our preliminary analysis, we estimate an implied trading multiple for the combined company of approximately 8.0x EBITDA, in which case these expected synergies would result in an additional $700 million in shareholder value, or approximately $8.75 per share."

20:03 EDT Essendant confirms unsolicited $11.50 per share offer from Staples - Essendant confirmed that it received an unsolicited proposal from Staples, Inc. to acquire all shares of Essendant stock for $11.50 per share in cash. Essendant's confirmation follows today's Schedule 13D filing with the U.S. Securities and Exchange Commission by Staples, Inc., Sycamore Partners and certain affiliates disclosing a 9.9% ownership stake in Essendant. On April 17, 2018, Staples communicated its initial proposal to Essendant, which Essendant declined after thorough review by its Board in consultation with its financial and legal advisors. Staples sent a revised proposal on April 29, 2018 stating that it believed it will be able to identify incremental value opportunities to enable it to increase its offer significantly in excess of $11.50 per share after receiving confidential information and engaging in discussions with Essendant.

19:12 EDT ChannelAdvisor executive chairman Wingo sells 50,000 common shares - In a regulatory filing, ChannelAdvisor executive chairman M. Scot Wingo disclosed the sale of 50,000 common shares of the company at a price of $14.59 per share.

19:09 EDT Met-Ed says service restored to roughly 39,000 customers - Service has been restored to approximately 39,000 Metropolitan Edison Company customers who lost power following the damaging thunderstorms that produced wind gusts approaching 70 mph as it blew across the Mid-Atlantic region late yesterday. Currently, approximately 20,000 Met-Ed customers remain out of service in eastern Pennsylvania, with more than 18,000 of those customers located in the Stroudsburg and Easton areas. Crews are addressing safety hazards and making progress restoring customers. The high winds caused significant damage to a major Met-Ed substation in Shawnee, in Monroe County, including damage to poles, wires, and transformers along a 34.5-kilovolt power line that is connected to the substation. At least a dozen poles are broken and there are multiple spans of downed wire, broken cross-arms, and other damaged equipment that will need to be replaced. The assessment process was delayed due to fog grounding helicopters that would normally have been used to patrol the difficult to access area. As a result, Met-Ed expects customers in the Easton area to be restored by late Friday, and customers in the Stroudsburg area to be restored by late Saturday. Met-Ed is a subsidiary of FirstEnergy.

19:03 EDT Xerox names John Visentin CEO - Xerox announced that its board of directors has appointed John Visentin as chief executive officer. Visentin was also elected vice chairman of the board of directors. Keith Cozza was elected chairman of the board of directors. Xerox also announced that it will hold its 2018 Annual Meeting of Shareholders on July 31, 2018. The board of directors has fixed the close of business on June 13, 2018 as the record date for the 2018 Annual Meeting. The company will continue to waive the advance notice bylaw to enable any Xerox shareholder to provide notice of intent to nominate directors for election or propose business at the 2018 Annual Meeting until June 13, 2018.

18:40 EDT Vivint Solar offering LC Chem RESU batteries to California customers - Vivint Solar announced it is now offering LG Chem RESU batteries, an energy storage system for household use, directly to its California customers. The company plans to expand this solar plus storage solution coast to coast throughout 2018. Following a customized professional installation by Vivint Solar, the battery immediately stores excess clean energy produced by the solar panels and delivers energy to the home without the customer needing to do anything. It also provides emergency backup power during grid outages. The solar plus storage solution can help further cut utility bills of customers in areas with time-of-use electricity rates (i.e. electricity costs change throughout the day). For example, customers in time-of-use areas can avoid peak hour costs day and night by using clean solar energy stored in the home battery system for consumption during these costlier periods.

18:09 EDT Endocyte presents phase 2 data for 177Lu-PSMA-617 at ASCO - Endocyte announced that a poster with data from the Peter MacCallum Cancer Centre will be presented on Endocyte's lead investigational therapy at the 2018 ASCO Annual Meeting on Saturday, June 2, 2018. Updated data from the phase 2 study of 177Lu-PSMA-617 as a potential treatment for metastatic castration-resistant prostate cancer, including data from an additional 20 patient expansion cohort, will be highlighted by the poster. "We are very pleased that we continue to see high rates of PSA response, even in heavily pre-treated patients," said Mike Sherman, president and CEO of Endocyte. "In the 50 patients receiving 177Lu-PSMA-617, 62% had a greater than 50% reduction in their PSA levels. Further, 44% of patients had a PSA reduction of 80% or greater. We look forward to sharing more information on this phase 2 trial at ASCO."

17:53 EDT Staples looks to have discussions to buy Essendant for $11.50 in cash - On April 17, Staples, a 9.9% stake holder in Essendant (ESND), sent a letter to the President and CEO and Board of Directors of the Essendant pursuant to which Staples expressed its interest in engaging in discussions with Essendant's Board of Directors regarding a proposal to acquire all of the remaining common stock of Essendant not owned by Staples. On April 27, the President and CEO of Essendant informed Staples that Essendant was not able to enter into discussions with Staples under the terms of the Agreement and Plan of Merger dated April 12 between Essendant Genuine Parts Company (GPC) and certain other parties thereto. After reviewing the GPC Agreement , on April 29, Staples sent a letter to the President and CEO and Board of Directors of Essendant which reiterated the terms of the April 17 Letter and encouraged Essendant to engage in discussions with Staples regarding its proposal. On Monday, May 10, Essendant sent a draft of an "Acceptable Confidentiality Agreement" The letter sent on April 29 said: "We were surprised and disappointed to receive your letter of April 27 indicating that Essendant's board of directors had determined that our proposal to acquire all of the outstanding shares of Essendant common stock for $11.50 per cash was not a "Superior Proposal" or even reasonably likely to lead to a "Superior Proposal" under your merger agreement with Genuine Parts Company . As you know, based on Friday's closing price of Essendant's stock, our proposal now represents a 44.5% premium over the public value attributed to your proposed combination with S.P. Richards. In addition, our proposed transaction has no financing risk as it will be fully financed with available cash and presents significantly less antitrust completion risk than your current transaction. We are therefore concerned that our proposal is not being thoughtfully and appropriately considered by your board of directors."

17:38 EDT Landcadia Holdings (Class A Stock) trading halted, news pending

17:32 EDT Celgene to present new blood cancer, solid tumor clinical data at ASCO - Celgene announced that data from more than 60 company-sponsored, cooperative group and investigator-initiated clinical studies evaluating Celgene agents will be presented at the American Society of Clinical Oncology Annual Meeting between June 1-5 in Chicago, Ill. In blood cancers, abstracts continue to support the role of Celgene's IMiD therapies as a foundation of multiple myeloma research. Multiple studies highlighting key Celgene research collaborations of investigational compounds will also be presented, including updated data from the first clinical study of anti-BCMA CAR T therapy bb2121 in multiple myeloma. In addition, results of the study evaluating the investigational R2 regimen REVLIMID and rituximab combination) as first-line therapy in previously-untreated follicular lymphoma patients will also be presented. Experts will also share results from a study of JCAR017, an investigational CAR T cell therapy, in relapsed/refractory aggressive b-cell non-Hodgkin's lymphoma. In solid tumors, data evaluating the investigational combination of atezolizumab with ABRAXANE + carboplatin will offer a first look at the clinical profile of an immunotherapy/chemotherapy combination in advanced squamous non-small cell lung cancer patients.

17:28 EDT Spectrum announces results from Rolontis study published in ASCO abstract - Spectrum Pharmaceuticals announced detailed results from ADVANCE, a Phase 3 trial of Rolontis, demonstrating that it was non-inferior to pegfilgrastim in the reduction of duration of severe neutropenia in all four cycles of the study. Rolontis is a novel long-acting granulocyte colony-stimulating factor being studied as a treatment for neutropenia in patients undergoing myelosuppressive cytotoxic chemotherapy. The data released in an abstract as part of the American Society of Clinical Oncology, or ASCO, 2018 Annual Meeting, also showed similar safety profiles between the treatment groups.

17:20 EDT Array BioPharma to present Phase 3 COLUMBUS trial data at ASCO - Array BioPharma announced that it will present data from the Phase 3 COLUMBUS trial of encorafenib and binimetinib in advanced BRAF-mutant melanoma in an oral presentation on June 4, at the 54th Annual Meeting of the American Society of Clinical Oncology, or ASCO, in Chicago, Illinois.

17:19 EDT Cerus announces additional BARDA funding for INTERCEPT - Cerus Corporation announced an amendment to the company's contract with the Biomedical Advanced Research and Development Authority, or BARDA. The expansion of the agreement provides an additional $15M in funding for supplementary support of both the ReCePI acute anemia clinical trial and SCient chronic anemia clinical trial. The total potential value of the amended contract with BARDA is $201M. Funding allocated to date now totals $103M in support of clinical development activities, including two U.S. Phase 3 studies, and the further development of the INTERCEPT system design in order to enable expanded use and manufacturing scale up of key components.

17:16 EDT Tesaro announces Zejula presentations at ASCO - Tesaro announced the presentation of five Zejula abstracts, including two oral presentations, at the 2018 American Society of Clinical Oncology, or ASCO, Annual Meeting, being held June 1 to June 5, 2018, in Chicago, Illinois.

17:12 EDT G1 to present 'promising' Phase 1b data on G1T38 at ASCO - G1 Therapeutics announced that preliminary data from its Phase 1b/2a clinical trial of G1T38 in combination with Faslodex will be presented in a poster session on June 2 at the 2018 American Society of Clinical Oncology, or ASCO, Annual Meeting, being held June 1-5 in Chicago, IL. These data showed promising safety and tolerability when G1T38 was dosed continuously as a treatment for people with estrogen receptor-positive, HER2-negative breast cancer. G1T38 is an oral CDK4/6 inhibitor with broad therapeutic potential in many forms of cancer and may serve as backbone therapy for multiple combination regimens.

17:11 EDT Verastem to present data on duvelisib and defactinib at ASCO - Verastem announced that five abstracts have been selected for poster presentations at the 54th Annual Meeting of the American Society of Clinical Oncology being held June 1-5, 2018 in Chicago. The company will present data on its lead product candidate, duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase delta and PI3K-gamma, as well as defactinib, its oral small molecule inhibitor of Focal Adhesion Kinase. The poster presentations will highlight the latest findings from the company's ongoing clinical trials for duvelisib, the Phase 3 DUO study crossover extension in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, in addition to a Phase 1 study of defactinib in combination with pembrolizumab and gemcitabine in patients with relapsed/refractory pancreatic cancer.

17:09 EDT Bristol-Myers to present immuno-oncology-based research at ASCO - Bristol-Myers Squibb Company announced that data from over 70 company-sponsored studies and collaborations evaluating its oncology compounds across more than 20 types of cancer will be featured at the American Society of Clinical Oncology, or ASCO, Annual Meeting 2018 in Chicago from June 1-5. Presentations will report data from clinical trials highlighting the potential role of immuno-oncology-based combinations, including translational research to help identify patient populations that may have the potential to benefit from I-O therapy. Additional findings include patient-reported outcomes and real-world data.

17:08 EDT Anchor Bolt Capital reports 6.9% passive stake in American Axle

17:08 EDT Just Energy reports Q4 EPS $1.40, may not compare to consensus 15c - Reports Q4 revenue $1.01B, may not compare to consensus $873.77M.

17:07 EDT Merck to present new Keytruda data at ASCO - Merck announced that new combination and monotherapy data from Merck's oncology portfolio, anchored by anti-PD-1 therapy Keytruda, will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology, or ASCO, in Chicago from June 1-5. More than 140 abstracts in over 25 tumor types have been accepted, including new and long-term data for Keytruda across multiple types of cancer.

17:06 EDT Syros sees opening the expansion phase of SY-1365 study in mid-2018 - Syros Pharmaceuticals announced that the company will present on the design of its Phase 1 clinical trial of SY-1365, a first-in-class selective cyclin-dependent kinase inhibitor, at the American Society of Clinical Oncology Annual Meeting taking place June 1-5, 2018 in Chicago. The Phase 1 trial is currently enrolling advanced solid tumor patients in the dose-escalation portion of the trial, with planned expansion cohorts to further evaluate SY-1365 as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations. Syros expects to open the expansion phase of the trial in mid-2018 and to report data from the dose-escalation portion of the trial in the fourth quarter of 2018.

17:05 EDT AbbVie to present investigational oncology portfolio at ASCO - AbbVie announced it will present data about the company's portfolio of investigational oncology medicines during the American Society of Clinical Oncology, or ASCO, annual meeting. More than 30 abstracts have been accepted, featuring data in hematologic malignancies and several solid tumor types, including brain cancer and lung cancer. Researchers will present data across multiple hematologic malignancies evaluating venetoclax, a BCL-2 inhibitor developed by AbbVie and Genentech, and ibrutinib, an inhibitor of Bruton's tyrosine kinase, or BTK. Additionally, updated data will be featured from AbbVie's late-stage investigational products including depatuxizumab mafodotin, an antibody-drug conjugate, or ADC, in amplified-epidermal growth factor receptor recurrent glioblastoma; rovalpituzumab tesirine, an investigational ADC targeting delta-like protein 3 expressing tumors, in small cell lung cancer; veliparib, an investigational oral poly polymerase inhibitor, across multiple solid tumors; elotuzumab, an immunostimulatory antibody that specifically targets signaling lymphocyte activation molecule family member 7, a cell-surface glycoprotein; as well as other early-stage investigational compounds, including ABBV-075, ABT-165 and PF-06647020 .

17:05 EDT Take-Two: 'Fortnite' won't change view about cross-platform availability - Says that nothing about "Fortnite" that changes view about cross-platform availability, says evaluates cross-platform and mobile availability on a case-by-case basis.

17:04 EDT Regeneron, Sanofi share 'positive' clinical data for cemiplimab - Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the first positive Phase 1 clinical data assessing cemiplimab as a potential treatment for advanced non-small cell lung cancer will be shared at the 2018 American Society of Clinical Oncology Annual Meeting. Cemiplimab is an investigational human monoclonal antibody targeting the immune checkpoint PD-1. As published online in advance of ASCO, interim results from the Phase 1 dose-escalation phase and expansion cohort of patients with advanced NSCLC showed that cemiplimab monotherapy resulted in an overall response rate of 29% and a disease control rate of 57 percent as of the data cut-off date. The duration of response exceeded eight months in five of six patients. In the trial, patients received either a 1 mg/kg dose or 200 mg flat dose of cemiplimab, each given every two weeks. The most common treatment-related adverse events were asthenia, pneumonitis and rash. "Cemiplimab is the foundation of our broader immuno-oncology program, and the clinical profile we've seen to date has encouraged us to explore the potential of this anti-PD-1 in multiple malignancies," said Israel Lowy, M.D., Ph.D., Vice President of Global Clinical Development and Head of Translational Science and Clinical Oncology, Regeneron. "In NSCLC, there remains a high unmet need despite recent advances. The positive Phase 1 results in advanced NSCLC support our strategy to advance cemiplimab in multiple Phase 3 trials exploring a number of treatment settings for this disease."

17:02 EDT Pfizer to showcase advanced of its growing portfolio at ASO - Pfizer announced that new data from its diversified portfolio of marketed and investigational oncology medicines will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology in Chicago from June 1-5, 2018. Data from programs in small molecules, immunotherapies, biomarker-driven medicines, as well as biosimilars, will be featured in more than 40 abstracts, including company-sponsored and collaborative research studies. The research to be presented includes new insights on Pfizer's late-phase investigational compounds dacomitinib, lorlatinib, talazoparib and glasdegib, as well as Pfizer's marketed therapy XTANDI. These compounds represent the next five potential Pfizer Oncology advancements in lung, breast, hematologic and prostate cancers.

17:01 EDT Ditech delays 10-Q filing, requires additional time - As a result of various factors, such as the timing of the filing of the Company's Form 10-K for the fiscal year ended December 31, as well as certain accounting and financial reporting matters, including the application of fresh start accounting in connection with the company's emergence from Chapter 11 Bankruptcy on February 9 Ditech Holding requires additional time to complete its financial closing procedures and, as a result, its independent registered public accounting firm requires additional time to complete the interim review of the company's consolidated financial statements as of and for the period ended March 31. Therefore, the company is not able to complete the preparation, review and filing of its Quarterly Report on Form 10-Q for the quarterly period ended March 31 within the prescribed time period without unreasonable effort or expense. The company currently expects to file its Form 10-Q as soon as reasonably practicable.

16:59 EDT Kadant authorizes $20M share repurchase - Kadant announced that its board has authorized the repurchase of up to $20M of its equity securities effective May 16 through May 16. The timing and amount of any repurchases will be at the discretion of company management and will be based on market conditions and other considerations, including limitations contained in our credit agreement entered into on March 1, 2017. Through May 16, 2018, under the existing $20M authorization that will expire on May 17, 2018, the company has not repurchased any shares of its common stock.

16:55 EDT Glenhill Advisors lowers stake in Joint Corp to 3.8% from 9.7%

16:53 EDT VIEX Capital lowers stake in Immersion to 1.4% from 7.5%

16:45 EDT Take-Two: NBA 2K esports league remains 'emergent growth opportunity' - Says "NBA 2K Online" remains very popular in China. Says 2K (TTWO) and Tencent (TCEHY) partnering to release "NBA 2K Online 2" this fall.

16:41 EDT Take-Two: 'Highly-anticipated' title from 'big' 2K franchise to launch FY20 - Says "highly-anticipated" title from one of 2K's "biggest franchises" is now planned for launch during fiscal 2020. Says player reaction to "Red Dead Redemption 2" trailer "phenomenal." Says will have additional "RDR2" details available in the coming months.

16:39 EDT Take-Two sees 'another year of profitable growth' in FY19

16:37 EDT Take-Two says 'NBA 2K18' company's highest selling sports title ever - Says "Grand Theft Auto 5" and "GTA Online" continue to exceed expectations, with continued year-over-year net bookings growth. Says Rockstar was able to continue growth from "GTA" with multiple free updates over the year. Says "NBA 2K18" continues to expand audience, says highest-selling sports title ever. Says average revenue per user increased double-digits in FY18. Says there remains "substantial" worldwide growth opportunity for "NBA 2K." Comments taken from Q4 earnings conference call.

16:33 EDT Laureate Education apoints Timothy Grace as Chief Human Resources Officer - Laureate Education appointed Timothy P. Grace as its new Chief Human Resources Officer, effective May 28. Grace will oversee all global HR functions within Laureate, including organizational design, talent acquisition and development, succession planning, compensation, learning, internal communications, and labor and employee relations. Grace most recently served as the Global CHRO for Toys"R"Us, where he was responsible for all HR activities.

16:27 EDT Ford restarts output of F-150 pickups in Kansas City ahead of schedule - Ford Motor Company is restarting production of the popular F-150 at Dearborn Truck Plant Friday after just over one week of downtime. The company has also successfully repaired the supply chain for Super Duty, with production targeted to restart by Monday at the Kentucky Truck Plant as well as the Kansas City Assembly Plant that also makes F-150 pickups. Work started immediately in the aftermath of the May 2 fire. Teams removed and remediated safety concerns - including dangling siding - and restored electricity, gaining approval to access the site while debris still smoldered inside. This allowed Ford and Meridian to safely retrieve and relocate tools to more quickly resume part production and work to minimize the financial impact of the stalled plants. Ford recovered, repaired and validated most dies that were at the Eaton Rapids facility, and Meridian is now producing parts for the F-150 at two locations - Eaton Rapids and Nottingham, U.K. Production of bolsters for Super Duty is also restarting at the Eaton Rapids plant.

16:25 EDT TakeTwo Interactive Software trading resumes

16:21 EDT Cisco drops almost 4% after Q3 financial results, guidance - Shares are currently down 3.5% to $43.56 after quarterly results.

16:18 EDT Cisco Q3 cash flow from operationb $2.4B, a decrease of 28% - Cash Flow from Operating Activities -- was $2.4B, a decrease of 28% compared with $3.4B for the third quarter of fiscal 2017. Operating cash flow includes the payment of $1.3 billion of one-time foreign taxes as related to the Tax Cuts and Jobs Act. Operating cash flow increased 11%, normalized for these tax payments.

16:16 EDT Cisco reports Q3 GAAP operating income was $3.1B, down 1% - GAAP operating income was $3.1B, down 1%, with GAAP operating margin of 25.1%. Non-GAAP operating income was $3.9B, up 2%, with non-GAAP operating margin of 31.5%.

16:16 EDT Mercury Systems receives $2.4M order - Mercury Systems announced it received a $2.4M order from a leading defense prime contractor to provide radar subsystems and related digital processing technologies for a missile defense application. The order was booked in the company's Q3.

16:15 EDT Cisco operating expenses up 6% in Q3 - Operating Expenses -- On a GAAP basis, operating expenses were $4.6B, up 6%. Non-GAAP operating expenses were $4B, up 6%, and were 32.5% of revenue.

16:13 EDT Take-Two reports Q4 net bookings $411.4M vs. $407.1M last year - Net Bookings from recurrent consumer spending grew 15% year-over-year and accounted for 58% of total Net Bookings. The largest contributors to Net Bookings were Grand Theft Auto Online and Grand Theft Auto V, NBA 2K18, Dragon City and Monster Legends, WWE 2K18 and WWE SuperCard, and Sid Meier's Civilization VI.

16:09 EDT Jack in the Box announces additional $200M share repurchase authorization - "We resumed share repurchases during the quarter, with the purchase of $100 million of stock, and last week our Board of Directors authorized an additional $200 million stock buyback program. We also completed an amendment and extension of our existing credit facility which is an interim step that provides an immediate increase in our borrowing capacity to 4.5 times EBITDA while we work with our advisors to evaluate longer-term financing alternatives. We remain comfortable with ultimately increasing our leverage up to 5.0 times EBITDA."

16:08 EDT Group 1 Automotive raises share repurchase authorization to $126M - Group 1 Automotive announced that its board of directors increased the company's common stock share repurchase authorization by $100M to $125.7M. To date, during the second quarter of 2018, the Company has repurchased 222,098 shares at an average price per common share of $66.26, for a total of $14.7M. The Company expects that any repurchase of shares will be funded by cash from operations. Repurchased shares will be held in treasury.

16:06 EDT PRGX Global appoints Deborah Schleicher as CFO - PRGX Global announced that the board has appointed Deborah Schleicher as CFO, Treasurer and Controller, effective May 21. Peter Limeri, the company's current CFO, Treasurer and Controller, will remain with the company until the end of June.

16:00 EDT TakeTwo Interactive Software trading halted, news pending

15:30 EDT Franklin Resources reports 13.3% passive stake in Talos Energy

15:14 EDT Iqvia remains down 3% after resuming trade following response to FDA

14:59 EDT Iqvia 'takes FDA's concerns seriously,' stands behind data methodologies - Iqvia, in response to an FDA statement earlier, issued a response that reads in part: "Recently, we made a correction to a kilogram conversion measurement in the United States IQVIA National Sales Perspective (NSP) market research service affecting reported measurements for transdermal patches in the opioid market. This kilogram measurement is reported in the NSP market research service. This measurement conversion issue does not impact our widely used US and global dollar and unit information in NSP or information in any other IQVIA market research services, methodologies or offerings. IQVIA's internal processes had already identified the measurement conversion issue prior to the FDA's notification. We notified our clients about this measurement conversion issue in April of this year. Ongoing steps have been undertaken to correct this measurement conversion issue in this offering. We stand behind our data methodologies. We value our long-standing relationship with the FDA. We take the FDA's concerns seriously and will continue working with the FDA to resolve these concerns to its satisfaction."

14:17 EDT Macy's results give boost to Ascena, other retail names - Shares of Ascena Retail (ASNA) are surging on Wednesday along with other retail names after Macy's (M) quarterly report gave hope to investors. Macy's Q1 results surpassed expectations on most measures. Macy's maneuvered a 3.9% jump in comparable sales on an owned basis, resulting in an almost 4% increase in revenue. Adjusted earnings per share of 42c in Q1 was up from 12c during the prior-year period. Analysts were expecting 35c. As a result, Macy's raised its 2018 EPS view to $3.75-$3.95, much higher than the $3.61 that analysts were forecasting. POSITIVE FOR RETAIL PEERS: Jefferies analyst Randal Konik said he liked Macy's "robust" revenue growth, clean inventories and controlled markdowns in the first quarter, though he also noted that Q2 comparable sales were expected to be down given the Friends and Family shift that aided Q1. Following the earnings report, Konik raised his price target on Macy's shares to $30 from $27, but he kept a Hold rating on the stock, citing secular pressures impacting the company and the industry. The analyst, who thinks Macy's report had a positive read-through for retail more broadly, continues to prefer Kohl's (KSS), citing its off-mall positioning, differentiated assortment, and "omni-channel leadership." PRICE ACTION: Shares of Ascena Retail Group are up 15.8% to $3.30 per share, while Macy's is up 11% to $33.20 per share in afternoon trading. OTHER RETAILERS FOLLOW: Shares of other companies in the space, including Express (EXPR), Francesca's Holdings (FRAN), Tilly's (TLYS), and Zumiez (ZUMZ), are all higher in afternoon trading.

13:37 EDT Blink Charging gets a nearly 40% boost after earnings amid expansion plans - Florida-based Blink Charging (BLNK) is getting the attention of investors after gaining almost 500% in less than two weeks. Shares in the EV charging company traded as low as 17c per share last summer before changing its name to Blink Charging from Car Charging Group and announcing a 1-for-50 reverse stock split. Shares in the revamped EV company traded as low as $1.28 in late April of this year. STOCK PRICE GETS CHARGED: News of an upgrade in the San Francisco Bay Area at 16 McDonald's franchises did little to move the stock in early May, but when the company announced on May 7 that Amazon's (AMZN) Whole Foods Market will be including Blink Charging at new locations, shares exploded 220% to around $5 per share. Shares went even higher on May 11 when it announced plans to expand its footprint in the Miami area with a "wave of new EV charging station installations." EARNINGS: Shares of Blink Charging were higher by as much as 37% after announcing first quarter results this morning. The company reported that total assets increased 335.4% to $11.7M from $2.7M, while net income increased to income of $2.2M from a loss of $3.1M. Also, noteworthy liabilities decreased 76.7% from $38.8M to $9M, the company said. EXECUTIVE COMMENTARY: "2018 is already turning out to be a transformative year for Blink Charging as we have launched into a new stage of growth following our $18.5M public offering on Nasdaq in February," said Michael D. Farkas, founder and executive chairman of Blink Charging. "Our financials are showing the result of coordinated and strategic deployment of charging stations and an increased revenue from our charging service. We are focused on the nationwide growth of charging stations at commercial and residential properties so that we will be present and accessible as millions of EV drivers begin pouring into cities across the country. We believe investment in technology will further drive property owners to adopt our various business model offerings so that they can take part in what is the beginning of a mass market EV adoption by the public." POSSIBLE TESLA ACQUISITION: In February, an article by Market Exclusive postured the idea that Blink could be a Tesla (TSLA) acquisition target near-term due to the size of the network it controls. According to the ME article, Tesla is in the process of increasing its driver access to its Superchargers "but this takes time." "An acquisition of Blink Charging could be a quick and easy way to expand considerably the company's network of chargers," the publication contended. PRICE ACTION: Shares of Blink Charging are up 37.4% to $7.48 in afternoon trading. OTHERS TO WATCH: Shares of AeroVironment (AVAV), which has an EV charging business, are falling about 3%.

13:22 EDT IQVIA Holdings Inc trading halted, news pending

12:55 EDT GameStop in focus after Tiger agitates for strategic review - Shares of GameStop (GME) are in focus on Wednesday after a hedge fund sent a letter to the game retailer's board calling on it to conduct a strategic review amid recent management reshuffling. TIGER LETTER: Earlier today, Julian Robertson's Tiger Management sent a letter to the board of GameStop urging the company to conduct a strategic review amid recent management shifts. "We view the recent management departures and crisis of confidence as an unprecedented opportunity for the Board to launch a strategic review and revive shareholder confidence in the sustainability of the GameStop business model," the letter reads, according to CNBC. Tiger noted in the letter that it plans to "remain a passive shareholder" and has "no intention of becoming an activist investor." The hedge fund added, however, that it would sell its shares if the retailer fails to implement a turnaround plan. Tiger has been building up its position in GameStop this year, CNBC noted. GAMESTOP RESPONSE: In response, GameStop confirmed to CNBC that it received Tiger's letter and said that it "welcomes" constructive feedback from the hedge fund and all of its investors. WHAT'S NOTABLE: Tiger's letter comes nearly a week after GameStop announced the resignation of Chief Executive Officer Michael Mauler, who left for personal reasons. The company noted at the time that Mauler's resignation was not due to any disagreement with the retailer regarding its "financial reporting, policies or practices or any potential fraud relating thereto." Mauler had only been in the position since February 6 following the resignation of J. Paul Raines for health reasons. Not long after Mauler began his new role, GameStop disclosed in a regulatory filing that it had terminated the employment of Chief Operating Officer Tony D. Bartel and executive vice president of strategic business and brand development Michael P. Hogan. LOOP BACKS HOLD: Following the Tiger letter, Loop Capital analyst Anthony Chukumba said he is "not terribly surprised" to see one of the game retailer's shareholders become more vocal given the recent underperformance and senior management turnover. Chukumba added that, while he is unclear whether there would be an takers for GameStop's struggling Technology Brands and view the company's International operations as a core business, he believes many of Tiger's demands make sense. The analyst added that he is not confident the letter will result in significant shareholder value creation given that the fund has a relatively small holding in GameStop, has not been an activist investor, and indicated its intent to "bail" if demands are not met. Chukumba maintained a Hold rating and $14 price target on the stock. PRICE ACTION: In afternoon trading, GameStop shares are up marginally to $13.56.

12:11 EDT Iqvia drops after FDA reports quality problems with data provided by firm - The FDA announced that its scientists recently discovered an inaccuracy in certain data provided to the agency by the IQVIA National Sales Perspectives database, including data on certain opioid drug products. "Data integrity and validity are critical to the work FDA does on behalf of the American public. When we discover irregularities or inconsistencies in the data we use, we take such deficiencies very seriously. While conducting analyses to estimate the amount of prescription opioids sold in the U.S., FDA found a discrepancy in the IQVIA data that showed a more than 20 percent drop in the reported amount, expressed in kilograms, of fentanyl sold for a minimum of the past five years compared to what IQVIA's database had previously reported. FDA immediately began an investigation into the cause of this discrepancy and its potential implications. Based on this investigation and discussions with IQVIA, it is our understanding that past data were overestimated by IQVIA because of an error in IQVIA's methods, which we believe resulted from IQVIA utilizing the wrong weight-based conversion factors to determine the amount of fentanyl in a given unit (such as a single fentanyl patch) for a subset of prescription fentanyl products. This error caused IQVIA to overestimate the total amount of fentanyl distributed into the marketplace when that estimated volume was expressed in kilograms. IQVIA has informed FDA that it is conducting a review of these data to ensure that they are now using the correct conversion factors for fentanyl products and that the new lower estimates are accurate. The FDA has asked IQVIA to notify customers who buy access to these data, including impacted federal agencies, of this error," the FDA stated. "These inaccuracies in the IQVIA data have no known implications for the safety and efficacy or the labeling of FDA-approved fentanyl products, and DEA has indicated that the IQVIA data is one of numerous factors it considers when determining the medical and research needs for Schedule I and II controlled substances. Since the FDA identified these issues, our scientists have been looking methodically at the IQVIA data for similar errors relating to other opioid and non-opioid controlled substances. Our effort is to assess whether the errors were more systematic and widespread, to determine the potential impact of such errors on FDA's work, and to provide recommendations for addressing this issue within the agency. We also reached out to federal partners, including the DEA. As a result of this work, we identified additional data quality issues related to several other controlled substances with similar weight-based conversion factors, including oxymorphone and hydrocodone. These additional errors raise serious concerns about systemic issues with IQVIA's data and quality control procedures...To address these challenges and concerns, FDA Commissioner Scott Gottlieb M.D., has called upon IQVIA to immediately retain a qualified independent, third party auditor to conduct a complete review of the data quality and quality control procedures of the controlled substance data utilized by the FDA. Commissioner Gottlieb also has requested that IQVIA hire a third party to conduct an independent audit of the data quality and quality control of all IQVIA products that FDA utilizes, as well as provide more transparency on the methods IQVIA uses to generate its data. The agency will be working with other federal partners on these issues and briefing members of Congress on IQVIA's data quality issues and their potential public health implications. We will provide updates to the public and our public health partners as appropriate," the agency added. Iqvia shares are down $2.72, or 2.7%, to $99.38 after the FDA announcement.

12:02 EDT IQVIA Holdings Inc trading resumes

11:58 EDT Iqvia drops after FDA reports quality issues with data

11:57 EDT IQVIA Holdings Inc trading halted, volatility trading pause

11:35 EDT Audentes Therapeutics reports six serious adverse events in ASPIRO - Audentes Therapeutics announced continuing positive data from the first dose cohort of ASPIRO, a Phase 1/2 clinical trial of AT132 in patients with X-Linked Myotubular Myopathy. ASPIRO is a multicenter, multinational, open-label, ascending dose study to evaluate the safety and preliminary efficacy of AT132 in approximately 12 XLMTM patients less than five years of age. The interim data includes safety and efficacy assessments as of May 12, 2018 for the first dose cohort of ASPIRO, comprised of six AT132-treated patients dosed at 1x1014 vector genomes per kilogram, and one delayed-treatment concurrent control patient. Individual patient follow-up ranged up to 24 weeks. There have been a total of 24 adverse events reported in ASPIRO, six of which were determined to be serious adverse events. One of the six SAEs occurred in Patient 4, the delayed treatment concurrent control patient, who was hospitalized for gastroenteritis at week 10. The patient has recovered and the event was determined to be not treatment-related. The remaining five SAEs occurred in Patient 3. The first was a hospitalization for pneumonia two weeks post study drug administration; the next three were a series of related SAEs that occurred seven weeks post study drug administration and included hospitalization for a gastrointestinal infection during which the patient experienced elevated creatine kinase and troponin levels suggestive of myocarditis. These events have been controlled with treatment, and cardiac function has not been compromised. The final SAE in Patient 3 was a hospitalization at week 21 for monitoring of atrial tachycardia, deemed possibly treatment-related. Patient 3 was noted to have experienced an episode of tachycardia prior to enrollment in ASPIRO. Patient 1 experienced three non-serious AEs that were determined to be possibly treatment-related, including mild, clinically asymptomatic exacerbation of pre-existing hyperbilirubinemia and mild unspecific abnormalities in liver ultrasound and proteinuria. Patient 2 experienced four non-serious AEs determined to be probably treatment related, including clinically asymptomatic hyperbilirubinemia; and liver enzyme and CK elevations which have been controlled by extended steroid coverage. There have been an additional 11 non-serious AEs in ASPIRO, all determined to be not treatment-related. There have been no significant treatment-related adverse events identified to date in Patients 5 through 7, referred to as the Cohort 1 expansion patients. The key assessment of neuromuscular function is the CHOP-INTEND scale, in which a maximal score of 64 reflects the level of neuromuscular function that a healthy baby is expected to approach by three to six months of age. Additional analyses to be reported based on longer term follow-up include the Motor Function Measure and Bayley-III scales of infant and toddler development. Motor developmental milestones are derived from each of the neuromuscular assessments.

11:27 EDT Zimmer says FDA made 11 inspectional observations after Warsaw inspection - As previously disclosed, the U.S. Food and Drug Administration recently performed an inspection of Zimmer Biomet's North Campus manufacturing facility in Warsaw, Indiana. The company announced earlier today that at the conclusion of the inspection on April 24, the FDA issued a Form 483 with 11 inspectional observations. "None of the observations identified a specific issue regarding the performance of any particular product and all products continue to be manufactured by the facility. Zimmer Biomet stands behind the safety of the products manufactured at the Warsaw North Campus," said Zimmer Biomet. "The company notes that this re-inspection occurred as it continues to execute against its approximately two-year quality remediation plan at the Warsaw North Campus. Zimmer Biomet believes that considerable progress has been made over the past year, but more work remains to be completed. The company takes the FDA's observations very seriously and, as part of the ongoing two-year remediation effort, continues to work diligently with independent consultants to address both existing and new Form 483 observations," the company added.

11:06 EDT 21st Century Fox: CFO John Nallen to take broader role as new Fox's COO

11:05 EDT 21st Century Fox: Lachlan Murdoch to serve as CEO of new 'Fox' - 21st Century Fox (FOXA) announced that its Executive Chairman Lachlan Murdoch will serve as Chairman and CEO of the proposed new "Fox," which will be formed after shareholder and regulatory approval of the proposed transaction between 21CF and The Walt Disney Company (DIS). The company also announced that Rupert Murdoch will serve as Co-Chairman of the new Fox, alongside Lachlan Murdoch; and that John Nallen, 21CF's CFO, will take a broader role as new Fox's COO. The new Fox will be home to such branded properties as Fox News Channel, Fox Business Network, Fox Broadcasting Company, Fox Sports, Fox Television Stations Group, and sports cable networks FS1, FS2, Fox Deportes and Big Ten Network. "We have worked through the winter 'standing up' a reimagined independent Fox. The strengths of the new company, a leader in News, Sports and Entertainment, present truly unique opportunities," said Lachlan Murdoch. "I am also personally very pleased that John has agreed to take on the role of COO, and together we look forward to making further announcements as to the management and structure of this new Fox as we get closer to closing our proposed transaction with Disney."

10:33 EDT Smurfit Kappa continues to believe best interests served by staying independent - The Board of Smurfit Kappa Group (SMFTF) noted the announcement made earlier today by the Irish Takeover Panel, setting, at the request of Smurfit Kappa, a deadline of 7 am on 6 June 2018 by which time International Paper must either announce an offer for Smurfit Kappa under Rule 2.5 of the Irish Takeover Rules or announce that it will not proceed with an offer for Smurfit Kappa. Smurfit Kappa welcomes the certainty this provides for the Group and all of its stakeholders. The Board also notes the announcement made today by International Paper. In particular, the Board notes International Paper's confirmation that it will not proceed with a binding offer unless it is recommended by the Smurfit Kappa Board. Smurfit stated: "The Board has unanimously rejected International Paper's proposals on the basis that they are significantly below the Board's assessment of the Group's true intrinsic worth and prospects and remain significantly below the valuations set by recent industry transactions...The Board continues to believe that the best interests of the Group's stakeholders are served by pursuing its future as an independent company, operating as the European and Pan-American leader in paper-based packaging. This announcement is made without the consent of International Paper."

10:19 EDT Before the Move: Watch Micron ahead of analyst day - RBC Capital analyst Amit Daryanani started coverage of Micron (MU) with an Outperform rating this morning, saying the company is offering exposure to DRAM and NAND memory markets at an attractive valuation. The company's analyst day meeting is scheduled for May 21, with Mizuho analyst Vijay Rakesh seeing it as a potential catalyst for the shares as it may reinforce a positive second half of 2018 outlook. ATTRACTIVE VALUATION: RBC Capital's Daryanani initiated coverage of Micron with an Outperform rating and a price target of $80 this morning , as he believes it offers a "unique way" for investors to gain exposure to DRAM and NAND markets at what he views as an "attractive valuation." While the down-price cycle in memory may not be over, the analyst contended that it is more "muted" than estimated and Micron is positioned to generate positive earnings per share and free cash flow in the current environment. Daryanani also pointed out he is positive on Micron's position in the long-term given the more diversified DRAM user base market with much more emphasis on mobile, reduced competition, and the potential for capital allocation steps to be taken. ANALYST DAY COULD BE CATALYST: In a research note of his own, Mizuho's Rakesh said he believes Micron's analyst day could be a catalyst for shares as it may reinforce a positive second half of 2018 outlook with Apple's (AAPL) iPhone/holiday build season and as NAND/DRAM pricing remain stable exiting the June quarter. Rakesh noted that he believes the focus will be on 2019 capex, thoughts on deleveraging/buybacks/dividends, the outlook for NAND and DRAM supply, demand and inventory in the second half of the year, and the ramp of new DRAM and NAND processes. The analyst reiterated a Buy rating and a $70 price target on the shares. Earlier this week, Evercore ISI analyst C.J. Muse told investors in a research note of his own that he expects Micron's analyst day on May 21 to be heavily focused on the CEO and CFO's plans for the ongoing transformation of the company. "Today's Micron is not the Micron of old, and neither is the memory industry," Muse said, adding that he expects management to highlight how memory is no longer just a commodity but a critical component in today's third wave of computing. Muse added that the company's improved financial position puts capital returns on the table and Micron could theoretically buy back as much as half of its stock over the next 3-4 years. "Since the market clearly will not allow this to happen, look for shares to continue to move higher," he contended. Muse reiterated an Outperform rating and $80 price target on Micron shares. "Before the Move" is The Fly's recurring series of exclusive stories that identify potentially market moving events, along with analyst predictions, ahead of the news.

10:04 EDT Medtronic initiates clinical study to assess safety of drug-eluting stents - Medtronic announced the initiation of a clinical study in the U.S. to assess the safety and efficacy of drug-eluting stents for the treatment of bifurcation lesions, which the company notes account for approximately 20% of all percutaneous coronary interventions. The Bifurcation Cohort, part of the Resolute Onyx Post-Approval Study, will include patients with coronary artery disease receiving the Resolute Onyx DES in sizes ranging from 2.0 mm - 5.0 mm in diameter. The Resolute Onyx DES is not approved for the treatment of bifurcation lesions in the U.S.

09:53 EDT Macy's CFO says still expects 2H comp sales to be higher than 1H

09:49 EDT Southwest raises quarterly dividend 28% to 16c per share - Southwest Airlines announces the Southwest Airlines Board of Directors at its meeting increased the company's quarterly dividend by 28%. The quarterly dividend will increase to 16c per share from 12.5c per share, beginning with the 167th consecutive quarterly dividend declared today to Shareholders of record at the close of business on June 6, 2018, on all shares then issued and outstanding. The dividend will be paid on June 27, 2018.

09:48 EDT Macy's CEO: 'This is the most competitive retail environment I've ever seen'

09:47 EDT Macy's CEO says plans to roll out mobile checkout to all stores by end of year - Macy's CEO Jeff Gennette said it is "encouraging" to see improvement in its B&M business. He said the retailer had the "wind at our back" in Q4 as consumer spending remained strong and there was a "significant" improvement in international tourist spending. Gennette noted that the new loyalty program having intended impact on customers. AUR was up 5% in Q1 vs. last year, he added. Gennette said Macy's is testing and fine tuning mobile checkout, and the retailer has plans to roll this out to every Macy's store by end of the year. Macy's also plans to scale VR offerings in its furniture stores to 60 more doors this year. Bloomingdale's and Blue Mercury had a "great" Q1, he added. He sees opening about 25 additional freestanding Blue Mercury stores this year. Comments taken from the Q1 earnings conference call. Macy's is up 7.5% to $32.18 in morning trading.

09:31 EDT Kratos Defense announces $18M in microwave electronics orders - Kratos Defense & Security Solutions announced that its Microwave Electronics Products Division has recently received approximately $18M in orders for electronic warfare and other systems. Work under these recent orders will be performed at secure Kratos manufacturing facilities. "Due to customer related, competitive and other considerations, no additional information will be provided related to these orders," the company stated.

09:06 EDT HealthStream COO J. Edward Pearson recieves promotion to president - HealthStream announced COO J. Edward Pearson has been promoted to president, effective immediately. Pearson will remain as COO as he concurrently assumes the new role of President. CEO and chairman of the board Robert Frist, Jr., who previously also held the title of president, will remain as the company's CEO and chairman.

09:04 EDT Verizon CFO expects 5G offering to be broadband-centric - Says fiber is an important asset for network and company can get access by leasing, building or buying. Says thinks building company's own fiber is best option economically. Says there will continue to be advances in 4G network. Says Spectrum is important part of the network and will continue to be. Says 5G offering will evolve over time but expect to see an offer that is broadband-centric. Expects to have a traditional video offering in OTT format. Expects to partner with third party for initial launch.

09:00 EDT Evolus Inc trading resumes

08:56 EDT Verizon CFO sees growing service revenue from this point forward - Verizon (VZ) CFO Matt Ellis says performance and experience on company's network continues to resonate with customers. Says company has grown accounts over the past 12 months. Says saw customers stepping up to unlimited in the past six to nine months. Says sees growing service revenue from this point forward. Says there is still a good chunk of customer base that can step up to unlimited. Says Comcast (CMCSA, CMCSK) launch hasn't had a material impact on business. Says using zero-based budgeting for $10B target for cumulative cash savings over a four-year period. Expects benefits to increase over the next couple of years. Says believes savings will result in both reinvestment in business and benefits to bottom line. Says combining transport layers of network will increase efficiency of network significantly. Says been doing densification process for five-plus years now. Expects spend to build out 5G is going to take advantage of a lot of the spend from the last five years. Says in Los Angeles, amounts of sites company has to add for 5G is a small fraction of total need. Says a lot of the hard work for 5G has been done. Says believes offering consumer services using 5G is going to offer a lot of upside for the company. Comments taken from the JPMorgan Global Technology, Media and Communications Conference.

08:46 EDT Pareteum awarded $2M agreement for WiFi services - Pareteum announced that their existing U.S. Wireless Internet Service Provider customer will expand connectivity options by adding SmartConnect technology through Pareteum's Global Cloud Service Platform, a single source solution. The amendment to the existing agreement will add $2M in revenue to the existing 3-year contract.

08:39 EDT Albireo Pharma enrolls first patient in Phase 3 PFIC trial of A4250 - Albireo Pharma announced the first patient has been enrolled in PEDFIC-1, a Phase 3 clinical trial of lead product candidate A4250, an ileal bile acid transporter inhibitor being studied for the treatment of patients with progressive familial intrahepatic cholestasis. PFIC is estimated to affect between one in every 50,000 to 100,000 children born worldwide and causes progressive, life-threatening liver disease. Moderate to severe pruritus is a common and problematic clinical presentation of PFIC that can severely diminish quality of life. In many cases, PFIC leads to cirrhosis and liver failure within the first 10 years of life, and nearly all patients with PFIC require treatment before age 30. There are currently no approved pharmacological treatment options for PFIC. The Phase 3 program includes a single randomized, double-blind, placebo-controlled clinical trial designed to evaluate A4250 in 60 patients, ages 6 months to 18 years, with PFIC, elevated serum bile acid levels and pruritus, and an open-label extension study to assess long-term safety and durability of response. Patients in the double-blind trial will receive a 40 or 120 mug/kg oral dose of A4250 or placebo once daily for 24 weeks. The primary endpoint for the US Food and Drug Administration evaluation will be an assessment of change in pruritus, and the primary endpoint for the European Medicines Agency evaluation will be sBA responder rate.

08:32 EDT Cboe Global Markets, IHS Markit, BlackRock partner on U.S. bond index futures - Cboe Global Markets (CBOE) announced a collaboration with IHS Markit (INFO) and BlackRock (BLK) for Cboe to develop the first-ever broad-based U.S. corporate bond index futures. The new futures' groundbreaking design will leverage the deep and liquid iShares ETF ecosystem and iBoxx index expertise to create exchange-listed products that are designed to reflect the performance of the broad U.S. high yield and investment grade bond markets. The futures are expected to provide liquid hedging vehicles for institutional investors with exposure to U.S. corporate debt, and will be listed and traded on Cboe Futures Exchange, pending regulatory review by the U.S. Commodity Futures Trading Commission.

08:28 EDT Viveve announces initiation of VIVEVE II clincal study - Viveve Medical announced that patient enrollment is underway in the multicenter randomized VIveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy clinical study to assess the safety and effectiveness of the Viveve System for the improvement of sexual function in women following vaginal childbirth. The VIVEVE II clinical study is a randomized, double-blinded, and sham-controlled trial with a planned enrollment of approximately 250 patients at up to 25 study sites in the United States and Canada. Subjects will be randomized in a 1:1 ratio for active and sham treatments. A staged approach, or roll-in, for clinical enrollment was required by the U.S. Food and Drug Administration in its Investigational Device Exemption approval letter to the company on March 19, 2018. In the first stage, enrollment is limited to 50 subjects. The roll-in will require safety review by the FDA of a minimum of 25 subjects, one-month post-treatment. Following the roll-in, an IDE Supplement will be submitted to the agency to expand the study up to its intended 250 patients. While the safety data from the initial 25 patients are being reviewed by the FDA, Viveve will continue to enroll up to an additional 25 patients. The primary efficacy endpoint is intended to be the mean change from baseline in the total FSFI at 12 months, following the submission of an IDE supplement. Patients will also be assessed for safety over the 12 months. The approved protocol also includes a variety of secondary and exploratory endpoints measured at six months post-treatment that address the efficacy of and improvement in FSFI domain scores for Desire, Lubrication, Orgasm, Arousal, Satisfaction and Pain.

08:19 EDT Wayfair announces new financing option for Canadian customers - Wayfair announced the availability of a new financing option available at Wayfair.ca. In partnership with PayBright, Wayfair customers in Canada now have the option to pay for orders over time with fixed monthly installments, making shopping on a budget for everything from furniture and decor to housewares and renovation items easier than ever before. Providing fixed, automatic payments, Wayfair.ca customers can now choose PayBright as their payment method for orders above C$400. Customers can complete their order on PayBright and view their monthly payments up front before making a final purchase.

08:16 EDT InspireMD receives approval for both CGuard EPS, MGuard Prime in Ecuador - InspireMD announced that it has received regulatory approval for the CGuard Embolic Prevention System, or EPS, and MGuard Prime from the Ministry of Health in Ecuador. Both of these devices utilize the company's patented MicroNet technology. In May of 2017 the company announced it had entered into an exclusive distribution agreement with CARDIOBENE S.A., a leading medical device distributor in Ecuador. The two companies have worked diligently to successfully secure these regulatory approvals. Sales for both products, CGuard EPS and MGuard Prime, will commence immediately in Ecuador.

08:09 EDT Eiger BioPharmaceuticals to collaborate with Progeria Research Foundation - Eiger BioPharmaceuticals (EIGR) announced a collaboration and supply agreement with The Progeria Research Foundation for the development and pursuit of FDA review and potential approval of lonafarnib for the treatment of Progeria in children. Lonafarnib will mark the first therapy submitted to the FDA for the treatment of Progeria. Occurring in approximately 400 children worldwide, Progeria is caused by a genetic mutation that results in an overabundance of the protein named progerin. Lonafarnib is not currently approved for use outside of clinical trials. Since 2007, PRF has funded four clinical trials to study lonafarnib's effect on Progeria. Published results of a study of lonafarnib in Progeria reported that treatment with lonafarnib alone compared with no treatment was associated with a significantly lower mortality rate after a median of 2.2 years of follow up. Merck (MRK) previously provided lonafarnib free of charge for use in PRF-sponsored clinical trials. Following a transfer of manufacturing technology from Merck in 2015, Eiger began to provide lonafarnib at no cost for use in ongoing clinical trials funded by PRF. Eiger has since expanded its licensing agreement with Merck to include rights to develop lonafarnib for the treatment of Progeria and will be responsible for regulatory execution, commercialization and distribution activities across the licensed and approved indications in the future.

08:06 EDT Fate Therapeutics, MSK Cancer Center expand scope of license agreement - Fate Therapeutics announced the company has gained access to additional intellectual property from Memorial Sloan Kettering Cancer Center that enables the development of gene-edited T-cell immunotherapies. The newly-licensed portfolio of intellectual property covers new chimeric antigen receptor constructs as well as off-the-shelf CAR T cells, including the use of CRISPR and other innovative technologies for their production. Fate Therapeutics is utilizing gene editing under its ongoing collaboration for the research and development of off-the-shelf CAR T-cell immunotherapies with Michel Sadelain, M.D., Ph.D., Director of the Center for Cell Engineering and the Stephen and Barbara Friedman Chair at MSK. At the American Society of Gene and Cell Therapy Annual Meeting, Dr. Sadelain will present preclinical data on FT819, an off-the-shelf, TCR-less, CD19 CAR T-cell product manufactured from a clonal master induced pluripotent stem cell line. The use of clonal master iPSC lines can overcome the complexity, heterogeneity and substantial costs associated with using cells from a patient or an allogeneic donor. Instead, iPSC-derived T-cell immunotherapies can be consistently and repeatedly mass produced and delivered in an off-the-shelf manner, significantly reducing the cost of, and time to, patient treatment. Fate Therapeutics has exclusively licensed from MSK intellectual property covering the production and composition of iPSC-derived T cells for human therapeutic use. In addition, Fate Therapeutics owns an extensive intellectual property portfolio that broadly covers compositions and methods for the genome editing of iPSCs using CRISPR and other nucleases, including the use of CRISPR to insert a CAR in the TRAC locus for endogenous transcriptional control.

08:06 EDT Office Depot to outline pivot to become omni-channel business services platform - Office Depot is hosting an investor and analyst day: Depot. Different!, to review the strategic transformation underway. Office Depot CEO, Gerry Smith, joined by his Executive Leadership team, will outline the compelling market opportunity for business services and Office Depot's pivot to becoming an omni-channel business services platform, providing end-to-end solutions for businesses of all sizes. The Office Depot executive leadership team will also use the meeting to introduce its plan for an integrated business services offering, Workonomy, designed to create a seamless customer experience. The offering will serve both small- to medium-sized businesses, or SMB, and enterprise customers, allowing them to create personalized support based on their business needs. SMB services will include administrative, technology and marketing solutions ranging from digital marketing to 3D printing to packing and shipping offerings. Enterprise services will include managed workplace solutions, infrastructure modernization, technology procurement and IT staffing.

08:05 EDT Macy's jumps 12% in pre-market trading after Q1 results

08:05 EDT Macy's says to remain active on Alibaba's ecommerce platform TMall - Macy's (M) said it has set a new approach to its business in China. The company has come to a mutual agreement to end the joint venture with Fung Retailing Limited. Macy's will remain active on Alibaba's (BABA) e-commerce platform TMall, as well as social media channels. The Macy's e-commerce team in San Francisco will manage the ongoing China business with operational support from Fung Omni in Shanghai.

08:04 EDT BioLife Solutions announces $1M equity investment in SAVSU Technologies - BioLife Solutions announced a $1M equity investment in SAVSU Technologies, a designer and manufacturer of innovative, high-performance cloud-connected storage and transport containers optimized for the cell and gene therapy supply chain. BioLife Solutions now owns 31% of SAVSU Technologies, up from 26% previously, after all historical capital contributions are accounted for. SAVSU's majority shareholder has also agreed to invest an additional $1M in SAVSU. In addition, SAVSU named Mike Rice, BioLife Solutions' CEO, and Roderick de Greef, BioLife Solutions' CFO, to its board of directors.

07:53 EDT Evolus Inc trading halted, news pending

07:33 EDT ADMA Biologics granted U.S. patent for treating respiratory infections - ADMA Biologics announced that the United States Patent and Trademark Office issued to the Company U.S. Patent No. 9,969,793 covering methods of treating respiratory infections. The newly issued patent encompasses methods of treating upper and lower respiratory infections, including those caused by Respiratory Syncytial Virus, or RSV, other viruses, as well as bacteria utilizing ADMA's investigational drug RI-002 that contains elevated, neutralizing antibody titers to RSV as well as elevated antibody titers to other respiratory pathogens, such as influenza virus, coronavirus, parainfluenza virus, and metapneumovirus. The term of the issued patent extends to January 2035.

07:07 EDT Roadrunner integrates three transportation businesses - Roadrunner announced the integration of Active Aero Group, USA Jet and Rich Logistics to unify the company's time definite ground and air transportation operations. Although all three legal entities will continue to exist, they will now be integrated and operate under one management team. The integrated business will go to market as Active On-Demand powered by Rich Logistics and USA Jet. On a combined basis this business platform has annual revenue in excess of $760M. The newly combined Active On-Demand entity will have five key areas of expertise including Scheduled Truckload, Ground Expedite, Air Charter, Hand Carry and International Airfreight.

07:04 EDT Cubic and 4C strategies partner in training solutions - Cubic's Cubic Global Defense business division and 4C Strategies have formed a new strategic partnership to cooperate globally in the development and delivery of next-generation training and readiness capabilities to shared customers. Under the agreement, Cubic and 4C Strategies will explore opportunities to further integrate the companies' complementary products, services and solutions. The partnership will provide open and scalable training solutions with a focus on customer outcomes rather than a "one-size-fits-all" proprietary approach. The companies anticipate improved aggregation between quantitative data generated within training simulation applications.

07:02 EDT Zoetis to acquire Abaxis for $83 per share, or approximately $2B in aggregate - Zoetis Inc. (ZTS) and Abaxis, Inc. (ABAX) announced a definitive merger agreement pursuant to which Zoetis will acquire Abaxis, a leader in the development, manufacture and marketing of diagnostic instruments for veterinary point-of-care services for $83 per share in cash, or approximately $2B in aggregate. The acquisition is expected to enhance Zoetis' presence in veterinary diagnostics, a category of the animal health industry with approximately 10% compound annual growth over the last three years. "This acquisition brings Zoetis a company that has a proven, competitive diagnostic platform for growth that we can help to accelerate in the U.S. and worldwide with our global scale and direct customer relationships in approximately 45 countries," said Juan Ramon Alaix, CEO of Zoetis. "Together we can bring more veterinarian customers a broader range of products that fit into our comprehensive solutions and innovations, from prediction and early detection of disease in animals to prevention and treatment. We are very excited by the passion for customers that Abaxis and Zoetis colleagues share." The transaction is subject to customary closing conditions, including regulatory approvals and the approval of Abaxis shareholders. Zoetis expects to complete the acquisition before the end of 2018, and it intends to fund the purchase through a combination of existing cash and new debt. Zoetis anticipates the transaction will have an impact on 2018 reported earnings related to customary closing activities; however, on an adjusted basis, the company does not expect a material impact. Zoetis will provide additional updates as the transaction progresses towards closing. Zoetis expects the transaction to be accretive to the company's earnings in 2019.

07:00 EDT Churchill Downs enters into real money online gaming and sports betting markets - Churchill Downs entered into real money online gaming and sports betting markets. It also entered a strategic partnership agreement with SBTech to utilize their integrated technology platform for CDI's iGaming and sports betting operations. SBTech will provide CDI with an iGaming platform, consisting of the consumer website, mobile apps, and back office systems to manage iGaming and sports wagering, where permitted, pursuant to which CDI may offer branded products separate from TwinSpires.com to its iGaming and sports betting customers. The strategic partnership with SBTech initially is intended to enable CDI to enter New Jersey and Pennsylvania, which have already approved iGaming and sports betting. In addition, the strategic partnership will enable CDI to enter Mississippi for sports wagering, subject to gaming license approvals and finalization of iGaming and sports betting regulations. In New Jersey, CDI has announced an agreement with Golden Nugget to enter the New Jersey iGaming and sports betting markets.

06:55 EDT Eagle Pharmaceuticals announces FDA approval for bendamustine HCI injection - Eagle Pharmaceuticals announced that the FDA has granted final approval for Eagle's ready-to-dilute, or RTD, bendamustine hydrochloride, or HCl, solution in a 500ml admixture for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Eagle's bendamustine HCl injection does not require reconstitution and is administered as a 500ml admixture over 30 or 60 minutes.

06:50 EDT Circle announces USD Coin, Bitmain partnership - In a blog post, the company said,"We announced the pending availability of tokenized US dollar coins supported by developments in the CENTRE open source framework and by a new partnership with Bitmain, which is also leading a $110M Series E equity investment in Circle. The invention of cryptographic assets and blockchain-based computing have ushered in the next major era of the open internet. But a price-stable medium of exchange and store of value is missing, and badly needed in order for global financial interoperability to function reliably and consistently. Transacting in currencies which fluctuate with extreme volatility creates complexity and fragile settlement contracts, especially when compared to transacting in 'tokenized fiat money' or fiat-pegged crypto assets. A price-stable currency, such as a token pegged to the US dollar, is critical for enabling mainstream adoption of blockchain technology for payments as well as for supporting maturation in financial contracts built on smart contract platforms, such as tokenized securities, loans, and property. There are several interesting approaches to solving this need, spanning algorithmic reimaginations of money supply to crypto-backed tokens to fiat asset-backed tokens. Circle USDC is a solution that enables customers to purchase and use USDC fiat tokens for payments and trading in the crypto ecosystem. USDC provides a full reserve US dollar-backed stablecoin, and is based on the open source fiat stablecoin framework developed and governed by CENTRE, which will provide independent oversight of Circle's offering...Bitmain is becoming a key supporter of CENTRE and USDC, and in conjunction with this new partnership, Bitmain is leading a $110M strategic investment in Circle. Also participating in this financing round are existing investors IDG Capital, Breyer Capital, General Catalyst, Accel, Digital Currency Group, and Pantera, along with new investors Blockchain Capital and Tusk Ventures...Bitmain will also join CENTRE's efforts to introduce multiple fiat-backed stablecoins and provide financial interoperability around the world. This partnership will help drive global interoperability that benefits consumers, business ventures, institutions, and marketplaces everywhere. Specifically, Bitmain will help CENTRE introduce multiple fiat stablecoins in a variety of geo-currency zones." Reference Link

06:35 EDT Eleven Biotherapeutics changes name to Sesen Bio - Eleven Biotherapeutics (EBIO) announced that the company is changing its name to Sesen Bio (SESN), effective on May 17. Additionally, the company announced the appointments of Hagop Youssoufian as senior medical advisor and Madhu Anant as vice president of regulatory affairs.

06:33 EDT Eleven Biotherapeutics changes corporate name to Sesen Bio - Eleven Biotherapeutics is changing its name to Sesen Bio. Sesen Bio will trade under the new Nasdaq ticker symbol "SESN," effective on May 17. The former ticker symbol "EBIO" will remain effective through the market close on May 16.

06:22 EDT International Paper supports Irish Takeover Panel timeline for Smurfit Kappa - Irish Takeover Panel announced that International Paper, or IP, has until 7:00 a.m. on June 6 to announce whether it will or will not make a binding offer for Smurfit Kappa Group under Rule 2.5 of the Irish Takeover Rules. IP supports the Panel's decision and favors a prompt resolution. International Paper believes its current proposal represents a compelling strategic and financial rationale for a combination with Smurfit Kappa. From the outset, IP has stressed the importance of proceeding on an agreed basis. To that end, IP confirms that it will not proceed with a binding offer unless it is recommended by Smurfit Kappa's board. Furthermore, International Paper confirms that it would seek a secondary listing on the London Stock Exchange to enable Smurfit Kappa shareholders to share in the potential value created by a transaction. IP would also provide Smurfit Kappa shareholders with a "mix and match" facility, which would allow Smurfit Kappa shareholders to elect, subject to other shareholders making countervailing elections, to receive a greater or lesser proportion of cash or International Paper shares. International Paper believes both companies should meet to discuss the synergy potential of the combined company and gain a better understanding of each company's current outlook, in order to explore a path forward to a recommended transaction.

06:12 EDT Yum!'s Pizza Hut, Telepizza Group announce international growth alliance - Pizza Hut, a division of Yum! Brands, and Telepizza Group, a pizza delivery company with more than 1,600 stores in over 20 countries, announced a strategic deal and master franchise alliance to accelerate growth across Latin America excluding Brazil, the Caribbean, Spain including Andorra, Portugal and Switzerland. The deal doubles Pizza Hut's footprint in the regions covered by the alliance; places Pizza Hut in the number one position in the category across Latin America and the Caribbean in terms of unit count. As a result of the alliance, Telepizza Group will become Pizza Hut's largest master franchisee globally by unit count and a leading multi-country pizza operator worldwide. Across all the markets covered in the alliance, Telepizza Group will oversee nearly 1,000 Pizza Huts and contribute nearly 1,500 of its stores to Pizza Hut's global unit count. Pizza Hut International franchisees in these regions will continue to operate their businesses, under the management of Telepizza Group as a Pizza Hut master franchisee. This strategic deal is a long-term initiative by Pizza Hut expected to result in accelerated unit development and operating profit growth on what will be a combined initial unit count of nearly 2,500 stores. The transaction is not expected to have a significant impact on Yum! Brands' core operating results or cash flows over the next few years.

05:42 EDT Regeneron says Dupixent Phase 3 trial met primary, key secondary endpoints - Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that a pivotal Phase 3 trial evaluating Dupixent to treat moderate-to-severe atopic dermatitis in adolescents, ages 12-17, met its primary and key secondary endpoints. In the trial, treatment with Dupixent as monotherapy significantly improved measures of overall disease severity, skin clearing, itching and certain health-related quality of life measures. Dupixent is the first and only biologic to show positive results in this patient population. Regeneron and Sanofi are studying dupilumab in a broad range of clinical development programs for diseases driven by Type 2 inflammation, including asthma, pediatric atopic dermatitis, nasal polyps, and eosinophilic esophagitis. Future trials are planned for chronic obstructive pulmonary disease, grass allergy and food allergy. These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority. Dupilumab was discovered using Regeneron's proprietary VelocImmune technology that yields optimized fully-human antibodies, and is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

05:38 EDT Walmart, Lord & Taylor to begin roll out of new online flagship store - Walmart.com (WMT) and Lord & Taylor announced that the companies will begin to roll out the new Lord & Taylor flagship store on Walmart.com in the coming weeks. The flagship, which will debut with more than 125 brands, including Tommy Bahama, Vince Camuto, Miss Selfridge, La La Anthony, Lucky Brand, H Halston and Effy, will be part of Walmart.com's broader fashion destination. Lord & Taylor is part of the Hudson's Bay (HBAYF) brand portfolio.

05:23 EDT Novartis General Counsel Felix Ehrat to retire, Shannon Thyme Klinger to succeed - Novartis announced that Felix Ehrat, Group General Counsel of Novartis, has decided to retire from the company. Shannon Thyme Klinger, currently Chief Ethics, Risk and Compliance Officer, will be appointed Group General Counsel, effective June 1, 2018. Ehrat, who has been Group General Counsel and Member of the Executive Committee of Novartis since 2011, has decided to retire from his position in the context of discussions surrounding Novartis' former agreement with Essential Consultants, owned by Michael Cohen. Ehrat said: "Although the contract was legally in order, it was an error. As a co-signatory with our former CEO, I take personal responsibility to bring the public debate on this matter to an end." Shannon Thyme Klinger is currently Chief Ethics, Risk and Compliance Officer. She became Chief Ethics and Compliance Officer and Global Head of Litigation in 2016 and joined the Novartis Executive Committee earlier this year.