Stockwinners Market Radar for September 13, 2017 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:12 EDT Cutera CFO sells 5,775 common shares - In a regulatory filing, Cutera outgoing CFO Ronald J. Santilli disclosed the sale of 5,775 common shares of the company at a price of $40.43 per share.

19:07 EDT Surmodics 'encouraged' by early patient data from PREVEIL study - Surmodics announced that data from the PREVEIL early feasibility study of the company's SurVeil drug-coated balloon was shared in a late-breaking clinical trial presentation at the Vascular Interventional Advances 2017 conference in Las Vegas. PREVEIL is a prospective, U.S., multi-center, single-arm trial designed to assess the safety and feasibility of the SurVeil DCB in the treatment of subjects with symptomatic peripheral artery disease due to de novo lesions of the femoral and popliteal arteries. Gary Ansel, MD, system medical chief of the Vascular Program at OhioHealth, presented six-month results from 13 patients (Rutherford class 2 to 4) at 3 clinical sites who were treated with the SurVeil DCB. Average lesion length was 56 mm. Clinical assessments included primary patency and late lumen loss through six months, plasma paclitaxel levels, and changes in Rutherford classification, resting ankle brachial index/toe brachial index, 6-minute walk test, and walking impairment questionnaire at 1, 6, 12, 24 and 36 months. Key secondary safety endpoints included freedom from major vascular complications, evidence of paclitaxel toxicity, or thrombolysis in myocardial infarction. Data from the study show that acute success measures of safety were achieved in 100 percent of subjects. Results also showed primary patency of 100 percent and mean late lumen loss of 0.27+/-0.54 mm at six months. Significant improvement in Rutherford classification, ABI/TBI, 6-minute walk test, and WIQ were seen at 30 days and six months. Median paclitaxel plasma concentration peaked immediately post-procedure and was undetectable at 30 days. Secondary technical, device, and procedure success criteria were achieved. "We are encouraged by the early patient data using the Surmodics SurVeil DCB platform and are excited to continue clinical evaluation of the product in the U.S. pivotal trial," said Dr. Ansel, who is a principal investigator in both the PREVEIL trial and the SurVeil DCB pivotal trial, TRANSCEND.

18:13 EDT HC2 Holdings to acquire assets of Mako Communications - HC2 Holdings has agreed to enter into an agreement with Mako Communications and certain of its affiliates to purchase all the assets in connection with Mako's ownership and operation of low power television stations. The transaction would result in HC2 acquiring 38 operating stations in 22 cities and is subject to the approval of the Federal Communication Commission, as well as other customary closing conditions.

18:01 EDT Alexion: Soliris study results show sustained treatment benefits - Alexion Pharmaceuticals announced results from an interim analysis of an ongoing Phase 3 open-label extension study of the pivotal, placebo-controlled REGAIN study of Soliris for the treatment of patients with refractory generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive. The new results show sustained treatment benefits across a range of MG-specific assessment scales through an additional 52 weeks for patients who continued to receive Soliris, and also demonstrate rapid, significant and sustained improvements through 52 weeks for patients who had crossed over from placebo in REGAIN to Soliris treatment in the extension study. The safety profile of Soliris was consistent with that observed in the REGAIN study. "There is an urgent need for a treatment for patients with refractory gMG who have attempted multiple therapies and continue to suffer from severe symptoms and complications," said Professor James F. Howard, MD, Department of Neurology at the University of North Carolina, Chapel Hill, USA, and lead investigator in REGAIN and its open-label extension study. "These new results build on the findings of the REGAIN study, and it is encouraging to see the rapid and sustained benefits of Soliris treatment with patients recovering functional ability to carry out activities of daily living, and quality of life."

17:45 EDT Equifax CEO Smith to testify before House in October 3 hearing - U.S. Representative Greg Walden, Republican chairman of the Energy and Commerce Committee, and Republican Representative Bob Latta sent a letter to Equifax chairman and CEO Richard Smith has agreed to testify at the Subcommittee on Digital Commerce Consumer Protection hearing on Tuesday, October 3, 2017. Reference Link

17:38 EDT Boeing awarded $599.99M government contract modification - Boeing Co., Seattle, Washington, has been awarded a $599,999,999 cost-plus-award-fee contract modification to previously awarded contract for new preliminary design activity requirements on the Presidential Aircraft Recapitalization Program. This contract modification supplements work already taking place under the PAR contract, including risk reduction activities and the acquisition of two commercial Boeing 747-8 aircraft. The modification will allow Boeing to complete preliminary design work for the modification of two 747-8 aircraft to replace the two aging VC-25A, Boeing 747-200, presidential support aircraft. The resulting modification to the aircraft, to be negotiated in a future contract modification, will include incorporating a mission communications system, electrical power upgrades, a medical facility, an executive interior, a self-defense system, and autonomous ground operations capabilities. Work will be performed in Seattle, Washington, and is expected to be completed by Dec. 31, 2018. This award is the result of a sole-source acquisition. Fiscal 2017 research and development funds in the amount of $102,189,578 are being obligated at time of award. Air Force Life Cycle Management Center, Wright-Patterson Air Force Base, Ohio, is the contracting activity.

17:35 EDT On The Fly: After Hours Movers - UP AFTER EARNINGS: United Natural Foods (UNFI), up 5.4%... Lakeland Industries (LAKE), up 4.4%. ALSO HIGHER: Tenet Healthcare (THC), up 11.7% after the Wall Street Journal reported that the company was exploring strategic options, including a potential sale... Scorpio Bulkers (SALT), up 3.7% after its board authorized a $50 share repurchase program. LOWER: Summit Therapeutics (SMMT), down 12.1% after it filed to sell $15M of American Depositary Shares... BiondVax (BVXV), down 6% after it filed to sell American Depositary Shares... Vanda (VNDA), down 5.9% after it said that results from as Phase II study of tradipitant improved itch and disease severity in patients with atopic dermatitis... US Foods (USFD), down 2.7% after it filed to sell 40M shares of common stock for holders.

17:26 EDT Dell Technologies sells over 2.3M VMware Class A common shares - In a regulatory filing, Dell Technologies (DVMT) disclosed the sale of 2,308,807 Class A common shares of VMWare (VMW) on September 11, 2017. No price was disclosed.

17:15 EDT Kirby expects impact from hurricanes to lower Q3 EPS by 6c-8c - Kirby announced that Hurricanes Harvey and Irma caused little damage to Kirby vessels and minor flooding to one facility. CEO Grzebinski stated, "Harvey has significantly dislocated normal supply and distribution routes in our inland barge business. Ports from Corpus Christi to Houston started closing on August 23rd, and began reopening on September 1st. Irma has also significantly disrupted our offshore business. We expect lost revenues and costs associated with recovery efforts for both hurricanes to impact Q3 EPS by 6c-8c per share. For Harvey, the lost revenues have been partially offset by an increase in our vessel utilization as the U.S. Gulf Coast petrochemical and refinery complex returns to normal operations. As such, we believe Q3 earnings results will fall within our previously provided guidance range, although towards the low end after the negative impact from the storms." The company had seen Q3 EPS of 40c-55c, consensus is 48c.

17:04 EDT Duke Energy restores power to 313,000 Carolinas customers post-Irma - Duke Energy said it has restored power to 313,000 North Carolina and South Carolina customers impacted by Tropical Storm Irma's high winds, and expects to restore electricity to the remaining 57,000 by 11 p.m. Friday, if not sooner. At the height of the storm, 171,000 Duke Energy customers in the Carolinas were without power simultaneously. More than 3,700 Duke Energy workers are making repairs to heavily damaged power lines and other electrical equipment in multiple cities, towns and rural areas in both states.

16:54 EDT Bruce Paul Eames reports 7.2% passive stake in ITUS

16:45 EDT Court dates revised for Ambac's Segregated Account's Rehabilitation hearings - Ambac Financial Group said that the Commissioner of Insurance for the State of Wisconsin, acting in his capacity as rehabilitator of AAC's Segregated Account, has revised the initial dates of the pre-trial hearing on the Segregated Account's Rehabilitation Plan Amendment to December 14, 2017 and the confirmation hearing to January 4, 2018 through January 5, 2018. The pre-trial hearing and confirmation hearing are related to the holistic restructuring transaction announced on July 19, 2017 designed to facilitate the conclusion of the rehabilitation of the Segregated Account. Ambac expects the Transaction to close during the first quarter of 2018, subject to court approval, among other conditions.

16:36 EDT Integrated Core Strategies reports 5.8% passive stake in NewLink Genetics

16:35 EDT Southwest, AFMA reach agreement in principle for FMT - Southwest and Aircraft Mechanics Fraternal Association, the Union that represents Facilities Maintenance Technicians, announced that negotiators have reached an Agreement in Principle that outlines the group's first contract. This is the second agreement reached by the parties and, if ratified, the five-year deal includes a complete set of work rules, a wage scale, and a ratification bonus. The Agreement in Principle is subject to final review by AMFA's National Executive Committee before it is submitted to its 37 members for a vote. A date for a ratification vote will be determined by AMFA in the near future.

16:35 EDT Terra Tech Corp expands retail dispensary operations into Santa Ana - Terra Tech announced that it has expanded its retail operations into Southern California through the acquisition of 100% of the assets of Tech Center Drive Management. Tech Center Drive operates The Reserve OC medical cannabis dispensary at 2911 South Tech Center Drive Santa Ana, CA 92705. Under the terms of transaction, Terra Tech has the right to operate the dispensary, and to consolidate 100% of Tech Center Drive's financial results into the Company's financial results. In addition, upon receiving regulatory approval from the city of Santa Ana, Terra Tech has the option to acquire the cannabis retail permit associated with the dispensary for no additional consideration.

16:31 EDT BioAmber notified by NYSE about non-compliance - BioAmber announced that the New York Stock Exchange has notified the company that it is no longer in compliance with NYSE listing standards because the price of its common stock has fallen below the NYSE's share price rule. The NYSE requires the average closing price of a listed company's common stock to be at least $1 per share over a consecutive 30 trading-day period. As of September 6, 2017, the 30 trading-day average closing price of the Company's common stock was 90c.

16:30 EDT Cadence Design names John Wall next CFO - Cadence Design Systems announced that John Wall, corporate vice president of finance and corporate controller of Cadence, has been appointed senior vice president and chief financial officer of Cadence, effective October 1, 2017. Geoff Ribar, current CFO of Cadence, will remain with the company as a senior advisor until his previously announced retirement at the end of March 2018. Wall, a 20-year Cadence executive, has been corporate controller for the past year-and-a-half, during which he has worked closely with Mr. Ribar to set and execute the company's financial goals.

16:28 EDT BB&T reopens South Florida branches after Hurricane Irma - BB&T has reopened the majority of its financial centers in the South Florida region in the wake of the damages left behind by Hurricane Irma. In the areas impacted by Hurricane Irma, clients will not be charged for the use of any non-BB&T ATMs; fees charged to BB&T clients by other financial institutions for the use of their ATMs will be refunded; non-BB&T clients who withdraw cash from a BB&T ATM will not be charged. BB&T announced a contribution of $500K to support disaster relief efforts in the aftermath of Hurricane Irma.

16:19 EDT SeaWorld names Yoshikazu Maruyama as Chairman, effective October 9 - SeaWorld announced that its Board of Directors has elected Yoshikazu Maruyama as Chairman, succeeding David D'Alessandro effective October 9. The company has also elected Donald Robinson as Lead Independent Director, effective October 9. Maruyama, a SeaWorld director since June 2017, is President of Zhonghong Group's American operation and represents the perspective of a significant, long-term shareholder. He brings over 20 years of global theme park and family entertainment industry experience and helped to lead the early turnaround of Universal Studios Japan, which was recently acquired by Comcast NBCUniversal. Robinson, a SeaWorld Director since June 2016, was formerly the Executive Vice President of Hong Kong Disneyland. He has extensive operations expertise, as well as over thirty years of executive and management positions in global theme park, retail, restaurant, resort, and entertainment businesses.

16:17 EDT Investors Real Estate acquires 500-unit multifamily property for $92.3M - IRET announced that it acquired Park Place Apartments for $92.3M. This 500-unit multifamily community is located in the highly desirable Twin Cities submarket of Plymouth, Minnesota.

16:13 EDT ImmunoCellular's plan of compliance accepted by NYSE - ImmunoCellular announced that the NYSE has accepted the company's plan to regain compliance with the exchange's continued listing standards. The company was previously notified that it was not in compliance with the stockholders' equity continued listing standard which requires stockholders' equity of $6.0M or more if the company has reported losses from continuing operations and/or net losses in its five most recent fiscal years. The company has been granted until December 23, 2018, subject to periodic review by the NYSE MKT for compliance with the initiatives set forth in the plan, to regain compliance. If the company is not in compliance with the continued listing standards by December 23, 2018, or if it does not make progress consistent with the plan during the plan period, the NYSE MKT staff may initiate delisting proceedings as appropriate. The notice has no immediate impact on the listing of the company's common stock, which will continue to trade on the NYSE MKT exchange under the symbol "IMUC," with the added designation of ".BC" to indicate that the company is not in compliance with listing standards.

16:11 EDT Manning & Napier reports preliminary AUM $27B as of August 31 - Compared with $27.3B at July 31 and $27.1B at June 30.

16:11 EDT Bankrate stockholders approve merger with Red Ventures - Bankrate stockholders voted to adopt the agreement and plan of merger providing for the merger of a wholly owned subsidiary of Red Ventures Holdco, with and into Bankrate, with Bankrate continuing as the surviving corporation and as a wholly owned subsidiary of Red Ventures. Approximately 99% of all votes cast, which represents approximately 90% of all outstanding shares, were voted in favor of the merger. Bankrate stockholders also approved the proposal to approve, on an advisory basis, certain compensation that may be paid or become payable to the company's named executive officers in connection with the merger. Bankrate stockholders will receive $14 per share in cash at the closing of the merger. Completion of the merger is subject to customary closing conditions, including the receipt of required regulatory approvals. The merger is expected to be completed by the end of 2017.

16:07 EDT YRC Worldwide: YRC Freight July tonnage 'essentially flat' vs. last year - YRC Worldwide reported certain operating metrics for the first two months of third quarter 2017. At YRC Freight, July 2017 tonnage per day was essentially flat compared to July 2016 and August 2017 tonnage per day decreased approximately 1.0% compared to August 2016. Quarter-to-date through August 2017, revenue per hundredweight increased approximately 3.8%. At the Regional Segment, July 2017 tonnage per day increased approximately 5.3% compared to July 2016 and August 2017 tonnage per day increased approximately 3.5% compared to August 2016. Quarter-to-date through August 2017, revenue per hundredweight increased approximately 1.3%. "While we are experiencing some near-term challenges as a result of Hurricanes Harvey and Irma, the economy remains stable," said James Welch, chief executive officer at YRC Worldwide. "We continue to believe in the fundamentals of our business and in the ability of our nearly 32,000 employees and 387 North American terminals to serve our customers and our investors well over the long term."

16:04 EDT Duke Energy: 800,000 customers' power restored after Hurricane Irma - Duke Energy has restored more than half of the customers who lost power as a result of Hurricane Irma - with 800,000 customers back on as of Wednesday afternoon. A total of 800,000 customers have been restored, but 600,000 Duke Energy customers are still without power in the state. More than 12,000 workers are working to safely and quickly restore service. Duke Energy serves 1.8M customers in Florida.

16:00 EDT Vanda trading halted, news pending

15:57 EDT AAC Holdings trading resumes

15:52 EDT GlaxoSmithKline confirms FDA panel votes in support of shingles vaccine - GlaxoSmithKline announced that the Vaccines and Related Biological Products Advisory Committee of the U.S. FDA voted unanimously that the data support the efficacy and safety of Shingrix, for the prevention of herpes zoster (shingles) in adults ages 50 and over. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. GSK's shingles candidate vaccine is not currently approved for use anywhere in the world. Regulatory filings in the European Union, Canada, Australia and Japan are underway.

15:43 EDT Kingdom Ridge reports 9.44% passive stake in Immersion

15:22 EDT Verizon CEO says nothing 'major' planned in terms of M&A - Verizon CEO Lowell McAdam was quoted as saying there is "no big M&A planned" for the company, which will be focused on 5G, fiber and digital media, according to Bloomberg's account of comments made at the "Sooner Than You Think" event. On the "almost hysteria" on Wall Street regarding M&A, McAdam reportedly said: "I still don't see it. I am a nice guy. I talk to everybody...[but] we are not looking for anything major."

15:05 EDT Thomas Barnes reports 5.62% stake in Barnes Group - To the knowledge of Thomas Barnes, as of July 26,, there were 53,837,680 shares of common stock of Barnes Group as set forth in the Form 10-Q for the quarter ended June 30. Thomas Barnes beneficially owned as of the date of this report 3,023,996 shares of common stock of the company, representing 5.62% of the outstanding Common Stock. As of September 12, Thomas Barnes has the sole power to vote or to direct the vote of 3,023,996 shares, sole power to dispose of 931,984 shares, and shared power to direct the disposition of 2,092,012 shares of Common Stock. On August 10, Thomas Barnes sold 2,000 shares of Common Stock on the New York Stock Exchange at a price of $59.93 per share. Thomas Barnes received $119,860 as a result of the sale.

14:57 EDT USG falls after CEO points out headwinds for Q3 during industry presentation - Shares of wallboard maker USG (USG) are falling after CEO Jennifer Scanlon spoke earlier at the RBC Industrials Conference. HURRICANE RALLY: Shares of the wall board maker have rallied nearly 30% since mid-August on the thesis that the destruction from this season's two powerful storms, Harvey and Irma, would drive demand for wall board and other building materials. CEO COMMENTS: Speaking earlier at the RBC Global Industrials Conference, CEO Jennifer Scanlon alerted investors to the fact that the company's Houston plant was shut down for a week due to Hurricane Harvey. Scanlon pointed out the obvious demand drivers from the rebuilding efforts that will transpire from the storms but noted that the plant damages from the storms will be a near term operational headwind, especially in the third quarter. Scanlon added that the company is "looking at" cost headwinds just from Harvey in the "$1M-ish" range. The CEO pointed out the change in the company's logistics to get raw materials due to storm damage. "You also do have to pay attention to the longer-term picture that a fair amount of raw materials, the chemicals, are used by this entire country are manufactured in that Texas region. So for the longer term, you also have to pay attention to what it's going to do to cost and inflation and supply chain. But for us in the third quarter, we do see some headwinds on that," said Scanlon during the presentation. Q3 CONSENSUS MAY BE OPTIMISTIC: "But I think it's important to point out that even prior to the hurricane when I was looking at consensus for third quarter and consensus for fourth quarter, in aggregate, the consensus numbers felt correct to me prior to the hurricane. But parsed out quarter-by-quarter, the third quarter felt more optimistic than some of the trends that we're seeing and the fourth quarter felt more pessimistic than some of the trends that we're seeing. And when you add the hurricane, I think it makes that even more pronounced," said Scanlon. WALLBOARD PRICING: Scanlon said that during conversations with customers during the summer about reconstituting price she feels that the company had "good conversations" with customers "despite the fact that we're not going to see pricing in the third quarter." INPUT COSTS RISING: During the company's presentation, the current cost problems with a key manufacturing component OCC, or old corrugated containers, came up. Scanlon pointed out that USG focuses on costs that the company can control, "but OCC is something that we can't control." Scanlon noted the incredible spike in OCC costs for USG due to the demand in China. PRICE ACTION: Shares of USG are down 4% to $30.70 per share in afternoon trading. OTHERS: Shares in other companies in the building materials space are all lower, including Vulcan Materials (VMC), Martin Marietta (MLM), Eagle Materials (EXP), U.S. Concrete (USCR), and Continental Building (CBPX).

14:23 EDT IOS simultaneously awards Olympic Games 2024 to Paris, 2028 to Los Angeles - Meeting in Lima, Peru, the International Olympic Committee elected Paris as host city of the 2024 Olympic Games and Los Angeles as host city for the 2028 games. "Congratulations to Paris 2024 and Los Angeles 2028! This historic double allocation is a 'win-win-win' situation for the city of Paris, the city of Los Angeles and the IOC," said the IOC President, Thomas Bach. "It is hard to imagine something better. Ensuring the stability of the Olympic Games for the athletes of the world for the next 11 years is something extraordinary." Discovery Communications has full European broadcast rights to the 2024 edition.Reference Link

14:20 EDT Anthem to participate in Connecticut healthcare exchange in 2018 - Connecticut Governor Dannel Malloy announced that Anthem (ANTM) and ConnectiCare Benefits have committed to participate in the state's health insurance exchange for 2018. Approximately 100,000 Connecticut residents purchase coverage through the exchange, the governor said in a statement. "With President Trump and Republicans in Congress attempting to sabotage the American healthcare system, we are incredibly pleased that Anthem and ConnectiCare will be offering health insurance plans in 2018 through Access Health CT," said Governor Malloy. "We appreciate their commitment to the tens of thousands of Connecticut residents who buy coverage though Access Health. I am grateful for the leadership of Lt. Governor Wyman, Commissioner Wade, and Access Health CT CEO Jim Wadleigh for their work to improve the stability of Connecticut's insurance marketplace."

14:03 EDT NJ reports August gaming revenue down 0.4% to $244.8M - New Jersey's Division of Gaming Enforcement reported that casino win from the industry was $223.6M, compared to $229.8M in August 2016, reflecting a 2.7% decrease. Internet gaming win was $21.3M, compared to $16.1M in the prior period, reflecting an increase of 32.4%. The industry's total gaming win for the month was $244.8M, compared to $245.9M for August 2016, reflecting a 0.4% decrease. Publicly traded companies in the casino gaming space include Boyd Gaming (BYD), Caesars (CZR), Las Vegas Sands (LVS), MGM Resorts (MGM), Penn National (PENN) and Wynn Resorts (WYNN).

13:40 EDT Marcato Capital nominates slate of ten director nominees for Deckers board - Marcato Capital, a San Francisco-based investment manager which manages funds that beneficially own approximately 6.1% of the outstanding common shares of Deckers Outdoor Corporation, announced that it has nominated a full slate of ten highly qualified candidates for election to the Deckers board of directors at the company's Annual Meeting of Shareholders to be held December 14, 2017. Mick McGuire, Managing Partner of Marcato, said: "Deckers has enjoyed a strong, profitable brand with UGG for many years, yet has failed to translate this enviable position into growth in earnings and shareholder value. Given the company's significant underperformance compared to peers, coupled with the board's failure to take the necessary corrective strategic action, we believe change is required. On numerous occasions we have sought to engage constructively with the board to add new directors and develop a strategy focused on profitable growth while improving margins and returns on invested capital. Unfortunately, our efforts to work collaboratively to enhance shareholder value have been met with significant resistance. While we appreciate that the company is undergoing a strategic review and we are eagerly awaiting the results of that process, we continue to believe that Deckers lacks proper oversight. Should the company's process not culminate in a desirable outcome, we believe the entire board must be replaced. Accordingly, today we are nominating ten highly qualified director candidates who bring the fresh perspectives and relevant retail, apparel and capital markets experience necessary to implement a strategic plan that will generate meaningful shareholder value." Marcato's ten nominees are Deborah M. Derby, Kirsten J. Feldman, Steve Fuller, Matthew P. Hepler, Robert D. Huth, Jan R. Kniffen, Mitchell A. Kosh, Nathanial J. Lipman, Michael W. Rayden, and Anne Waterman.

13:33 EDT Pep Boys acquires Newpark Auto Service; terms not disclosed - Pep Boys, a wholly-owned subsidiary of Icahn Automotive Group LLC, announced it has acquired Newpark Auto Service in Newark, California. Six-year-old Newpark has seven bays and will be transitioned into a Pep Boys Service & Tire Center.

13:15 EDT Apple shares down $1.90 to $158.96

12:51 EDT 21st Century Fox still sees Sky deal closing mid-2018 - 21st Century Fox (FOX, FOXA) Executive Chairman Lachlan Murdoch says he is confident company will meet $1B EBITDA 2020 target for Star TV. Says "very disappointed" the U.K. regulator has asked to further study Sky (SKYAY) deal, still confident the deal will be completed by mid-2018. Sees high single digit subscriber growth. Regarding cord-cutting, Murdoch says "No reason we shouldn't be flat going forward," combining new online distribution with pay TV. Murdoch says the company is looking to launch direct t o consumer services. Comments taken from the Goldman Sachs Communacopia Conference.

12:15 EDT EnviroStar says subsidiary operations unaffected by Hurricane Irma - EnviroStar announced that EVI's corporate office and the operations of its Miami, Florida based subsidiary, Steiner Atlantic, were unaffected by the weather associated with Hurricane Irma and thanks to its dedicated employees, EVI and Steiner Atlantic have resumed normal and ordinary operations. "EVI's thoughts and prayers go out to all those affected by Hurricane Irma. While it is too early to assess the full impact of Hurricane Irma to its laundry customers across the affected areas in Florida, the Florida Keys, and the Caribbean, the team at Steiner Atlantic is prepared to handle all sales, service, and installation matters necessary to help all laundry customers return to normal operations as soon as possible," the company said.

12:08 EDT Viacom CEO: Brexit a 'near-term dampener'

12:00 EDT Lexicon slides after NEJM publishes diabetes study results - Lexicon Pharmaceuticals after lower after the company announced earlier that the New England Journal of Medicine, or NEJM, published the results of the Phase 3 inTandem3 study of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, for the treatment of patients with type 1 diabetes on any background insulin therapy. The data were published online today in conjunction with presentation of these data at the European Association for the Study of Diabetes, or EASD, annual meeting. The study met its primary endpoint with statistical significance, demonstrating the superiority of sotagliflozin 400 mg compared to placebo in the proportion of patients with A1C less than7.0% at Week 24 and no episode of severe hypoglycemia and no episode of DKA after randomization. The responder rate for patients on sotagliflozin was approximately twice the rate as compared to placebo. The difference compared to placebo for patients treated with sotagliflozin was 13.4%, the company reported. The outcome on every secondary endpoint achieved statistical significance favoring sotagliflozin over placebo, including change from baseline in A1C, body weight, systolic blood pressure in patients with baseline SBP greater than or equal to130 mm Hg and bolus insulin. "Sotagliflozin demonstrated a generally well tolerated safety profile during a 24-week treatment period, with rates of treatment-emergent adverse events, serious adverse events, and discontinuations due to adverse events that were consistent with rates seen in two prior pivotal Phase 3 studies," Lexicon said. Lonnel Coats, Lexicon's president and CEO, added, "As we remain committed to advancing the science in diabetes and bringing innovative therapies to patients to help improve outcomes and ease the burden of managing their diabetes, we look forward to Sanofi's filing for global regulatory approval for type 1 diabetes in the first half of 2018." In midday trading, Lexicon shares have slid $1.39, or 9.46%, to $13.35.

11:52 EDT Zillow slides as analyst says CFPB suit is likely - Shares of Zillow (Z) are sliding after Susquehanna analyst Thomas Claps told investors that he believes a lawsuit may be forthcoming from the Consumer Financial Protection Bureau over its co-marketing program. The analyst pointed out that CFPB had "invited" the company to discuss a settlement, but no progress update on the discussions has been announced. CFPB MAY SUE ZILLOW: In a research note to investors, Susquehanna's Claps noted that on August 8, Zillow disclosed that the CFPB had concluded its investigation and "invited" the company to discuss a settlement, which was to occur over the past month. However, to date, there has been no progress update on the settlement discussions, the analyst pointed out, adding that the likelihood of a near-term lawsuit being filed is increasing. Currently, Zillow's co-marketing program allows certain groups of lenders to subsidize up to 90% of an agent's marketing costs, while other lenders are capped at 50%, Claps said. The analyst argued that this subsidy issue is the primary focus of the CFPB investigation, and that the CFPB is likely demanding a 50% contribution cap across the board, regardless of how many lenders are contributing. Therefore, at a bare minimum, the CFPB will demand that Zillow eliminates its ability to collect more than a 50% co-pay from lenders, he added. The analyst reiterated a Neutral rating on Zillow. POTENTIAL LAWSUIT IMPLICATIONS: Susquehanna's Claps also argued that if the CFPB files a lawsuit against Zillow in the near-term, it will be seeking a variety of remedies and monetary fines against Zillow, which could mean total elimination of Zillow's co-marketing program, reduction in co-marketing contribution amounts that would result in lost revenues/EBITDA, disgorgement of profits, civil monetary penalties, banning single lender agreements, increased consumer disclosures and increased compliance measures. PRICE ACTION: In late morning trading, shares of Zillow have dropped over 4% to $38.88.

11:47 EDT Viacom CEO sees launching non-sports entertainment bundle this year - Viacom President and CEO Bob Bakish says that the MTV revitalization "already starting to happen." Commenting on pay TV subscriber trends, Bakish says the U.S. pay TV industry is "in a transition where certain elements have yet to emerge." Says there is "clear data" to suggest that lower price point entertainment bundle that doesn't include sports "has appeal," sees bundle this calendar year. Comments made by Bakish at the Goldman Sachs Communacopia Conference.

11:32 EDT Centene jumps after expanding to NY market with accretive Fidelis acquisition - Health insurer Centene (CNC) is advancing on Wednesday after the Medicaid coverage provider announced Tuesday night a "highly accretive" acquisition of Fidelis Care for $3.75B. Fidelis Care is a health plan that offers affordable health insurance coverage in New York. EXECUTING ON ACA EXCHANGES: As other healthcare insurers like Aetna (AET) and UnitedHealth (UNH) step back from the Affordable Care Act's challenged insurance exchanges, Centene, which specializes in the state and federal Medicaid programs for less advantaged and underserved, continues to execute on the ACA's public insurance exchange, even as President Trump warns of the imminent collapse of the ACA and its exchanges. As of June 30, the company almost doubled the number of its clients in plans purchases on ACA exchanges to 1.1M compared to 617,000 at the same time period in 2016. EXPANDS TO NY WITH FIDELIS: In the Fidelis deal, Centene will now have a "leadership" position in New York, the country's second largest managed care state by membership. The health insurer now will have a leadership position in the country's four largest managed care states by membership -- California, Florida, New York, and Texas. Fidelis Care is a not-for-profit corporation that is a diversified leader in government programs, serving over 1.6M members as of June 30. "We believe our over 30 years of experience, our local approach to the provision of healthcare, and our expertise and capabilities in caring for underserved populations will support the next generation of leadership in government programs in New York State," said Michael F. Neidorff, Chairman, President and CEO of Centene. With the Fidelis acquisition, Centene expects to generate 2018 pro-forma total revenues of over $60B assuming a January 1, 2018 closing date. The transaction is expected to generate immediate accretion to year one GAAP earnings per share, high single-digit and low- to mid-teens percentage accretion to adjusted earnings per share in year one and year two, respectively. Centene expects to achieve $25M of pre-tax net synergies in year one and $100M run-rate synergies beginning in Year two. Synergies will come from areas primarily attributable to reduced medical costs through the use of Centene's systems and medical management, said the company in a statement. ANALYSTS APPLAUD: On the heels of the announcement, Leerink analyst Ana Gupte raised her price target for Centene to $90 from $78 as she is positive on it after the announcement. The analyst reiterated a Market Perform rating on the shares. Cantor analyst Steven Halper also raised his price target for Centene shares to $107 this morning, keeping an Overweight rating on Centene. Fidelis Care is a strong fit, both culturally and in terms of business mix, for Centene, said Morgan Stanley analyst Zack Sopcak, calling the acquisition a deal "in Centene's wheelhouse." PRICE ACTION: Centene is op over 6% to $96.51 per share in morning trading.

11:18 EDT Ballard Power to offer first NPMC-based PEM fuel cell product - Ballard Power Systems announced that the company has collaborated with Nisshinbo Holdings to develop a Non Precious Metal Catalyst for use in the world's first commercialized NPMC-based proton exchange membrane fuel cell product. Nisshinbo and Ballard have jointly collaborated on the development of NPMC since 2013. Ballard has successfully incorporated the Non Precious Metal Catalyst into a high performing catalyst layer under a Technology Solutions program and plans to launch a new 30-watt FCgen-1040 fuel cell stack product incorporating NPMC for commercial use in late-2017. The NPMC-based FCgen-1040 fuel cell stack will be a variant of Ballard's FCgen-micro fuel cell stack, derived from the Company's air-cooled fuel cell technology designed for integration into ultra lightweight applications. In morning trading, Ballard shares rose 63c, or 16.9%, to $4.34.

11:06 EDT Finish Line rallies after analyst puts chance of takeover at 75% - The shares of Finish Line (FINL) are rallying after research firm Susquehanna upgraded the athletic apparel retailer to Positive from Neutral. The firm thinks there is a 75% chance that Finish Line will be acquired, most likely by U.K.-based sporting good retailer Sports Direct. POISON PILL: Finish Line implemented its poison pill on August 28 because it wanted to force Sports Direct into talks and prevent it from completing an acquisition through a hostile takeover or by buying shares on the open market, wrote Susquehanna analyst Sam Poser. The fact that Finish Line's shares were near a five year low made this priority more urgent for the retailer, the analyst stated. 75% CHANCE: There is a 75% chance that Sports Direct will buy Finish Line for about $13.30 per share and a 25% chance that it will remain a standalone company, causing its stock to drop to $8, the analyst wrote. Before today's open, the stock reflected only a 30% chance of an acquisition, he stated. WHAT'S NOTABLE: As of late July, Sports Direct noted it held a stake in Finish Line of 19.7%. At that time, Sports Direct issued an amended filing to refer to its sale of put options in Finish Line. TARGET: Poser raised his price target on Finish Line to $12 from $9. PRICE ACTION: In morning trading, Finish Line jumped about 7% to $10.40.

10:58 EDT U.S. Bancorp: Loan growth being impacted by policy uncertainty, higher paydowns

10:51 EDT Loxo Oncology says 292 data to be presented at upcoming lung cancer conference - Loxo Oncology announced earlier that its investigators will present initial clinical data for LOXO-292 at the International Association for the Study of Lung Cancer, or IASLC, World Conference on Lung Cancer to be held October 15-18. The oral presentation will include case reports for two patients with RET fusion lung cancer, previously treated with multikinase inhibitors, who received LOXO-292, Loxo Oncology's highly selective RET inhibitor in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection kinase. In morning trading, Loxo shares have jumped $12.09, or 16%, to $87.20.

10:47 EDT U.S. Bancorp cuts Q3 total loan growth view to 'slightly below' Q2's 0.9% - President and CEO Andy Cecere says there are "no businesses we're seeking to get out of or into." Says current business mix "optimal." Cecere says 80% of transactions occur on a mobile device, but only 20% of sales occur on a mobile device. Sees Q3 total loan growth slightly below 0.9% growth experienced in Q2 vs. prior view of 1%-1.5% growth. Sees NIM up about 5bps in Q3 on a linked quarter basis vs. prior 4-5bps view. Sees merchant processing revenue about flat in Q3. Sees Q3 tax rate 29%, up from Q2. Comments made by Cecere at the Barclays Global Financial Services Conference.

10:27 EDT CBS streaming seen being worth over $7B as cord-cutting grows - A day after The Wall Street Journal reported that two media agencies had downgraded their forecasts for global ad spending, eMarketeter said it has also reduced its estimate for U.S. TV ad spending due to "faster-than-expected growth in cord-cutting." Meanwhile, Needham analyst Laura Martin told investors that CBS' (CBS) Over The Top, or OTT, assets could be worth $7.2B. CORD CUTTING GROWING: On Monday, The Wall Street Journal reported that two media agencies downgraded their forecasts for global ad spending in 2017 and 2018, citing political uncertainty in the U.K. and slowing growth in China, among other reasons. WPP's (WPPGY) GroupM is now expecting 3% global ad growth in 2017, down from 4.4%, while Publicis Groupe's (PUBGY) Zenith predicts global ad spending will grow 4% in 2017, down slightly from the 4.2% growth forecasted in June, the publication added. Today, eMarketer said it has reduced its estimate for U.S. TV ad spending due to "faster-than-expected growth in cord-cutting" and the corresponding audience shrinkage. The research firm pointed out that consumers shifting their attention to OTT digital video platforms in place of pay TV options is a key reason for anemic growth in TV ad spending, and said it has increased estimates for cord-cutters substantially for 2017 through 2021. eMarketer predicts there will be over 22M cord-cutters this year, up 33% over last year and a big step-up from its earlier estimate of 15.4M. CBS OTT CHANNELS VALUED LIKE NETFLIX?: In a research note to investors, Needham analyst Laura Martin questioned if CBS All Access plus its other OTT channels together "should be valued like Netflix [NFLX]." The analyst noted that she expected CBS All Access plus Showtime OTT will reach over 8M subscribers by 2020, implying about $850M of annual new subscription revenue, with CBS News and CBS Sports OTT services also adding to this revenue upside. If together all CBS OTT services generate revenue of $1.2B in 2020, she contented, and assuming a current Netflix (NFLX) revenue multiple of 6 times revenue, the analyst believes this implies hidden value from CBS's OTT assets of $7.2B, or nearly 30% of CBS's current market capitalization. Martin told investors that she believes CBS has a "nesting strategy" for its OTT assets, and that content will be the key driver of new subscribers. The analyst reiterated a Buy rating and $80 price target on CBS shares. PRICE ACTION: In morning trading, shares of CBS have gained almost 2% to $59.96.

09:42 EDT International Paper raises 2018 synergies run-rate to $200M - International Paper in conference presentation slides raised its acquisition synergies run-rate in Global Cellulose Fibers to $200 from $175M for 2018 and $140M from $100M in 2017.

09:38 EDT U.S. Bancorp sees long-term ROA 1.35%-1.65%, ROE 13.5%-16.5% - In slides being presented at the Barclays Global Financial Services Conference, U.S. Bancorp provided long-term expectations, including ROA of 1.35%-1.65%, ROE 13.5%-16.5%, return on tangible common equity 17.5%-20% and efficiency ratio in the low 50s.

09:32 EDT Coffee Holding announces $2M stock repurchase program - Coffee Holding's board has approved a share repurchase program pursuant to which the company may repurchase up to $2M in value of its outstanding common stock. The company intends to fund the share repurchase program with available cash and from future cash flow from operations.

09:22 EDT CDI Corp. trading halted, news dissemination

09:18 EDT RLJ Lodging Trust reports 'no material property damage' following hurricanes - RLJ Lodging Trust provided an update with respect to the company's properties following Hurricanes Harvey and Irma. "Our thoughts and prayers go out to the people impacted by these two devastating hurricanes," commented Ross Bierkan, president and CEO. In Texas, all of the company's 11 hotels in the Houston market remain operational. To date, there has been no material property damage reported. RLJ's hotels in the Austin and San Antonio markets have also remained operational and were largely unaffected. In Florida, eight of the company's 20 hotels had been temporarily closed to comply with mandatory evacuation orders. A number of the closed hotels are in the process of reopening as evacuation orders are lifted at their respective locations. Based on preliminary information, no material property damage has been reported. RLJ maintains comprehensive insurance coverage on all of its hotels including property, flood and business interruption. The company is working with its insurance providers to assess the overall impact from the two storms and expects the assessment to take several weeks to complete.

09:16 EDT FCB Financial reopens banking centers following Hurricane Irma - The company said, "We opened 25 banking centers in all of our major markets, providing full services to our valued consumer and commercial customers. As your community banking partner, we at Florida Community Bank want to ensure our customers and communities are informed on the status of their local banking institution operations now that Hurricane Irma has passed. Our commercial and consumer bankers have been contacting customers to offer assistance. 'FCB, your Florida Based and Florida Focused institution, is committed to being open for business and is already working with customers to ensure our communities recover quickly. Our thoughts and energy are directed to our customers, employees and neighbors impacted by Hurricane Irma," said Kent Ellert, president and CEO. "Our organic, know your customer approach to community banking has enabled us to quickly reach out across our customer footprint to understand the scale of the impact. Preliminary feedback indicates that luckily, like myself, our customers are mostly experiencing severe inconveniences rather than critical or structural needs with isolated exceptions in certain areas. We expect many of these to be resolved as fuel and electrical services are restored and cleanup efforts progress.'" .

09:06 EDT Shell, Toyota and Honda to build seven hydrogen refueling stations in California - The California Energy Commission awarded a grant of $16,362,500 to Equilon Enterprises, a subsidiary of Shell (RDS:A) for the introduction of seven hydrogen refueling stations in Northern California. The hydrogen refueling stations will be built in collaboration with Honda (HMC) and Toyota (TM), who will provide financial support, at seven Shell-branded retail stations across Northern California.

09:03 EDT Dish Media announces cross-platform addressable ad campaign with Volvo Cars - DISH Media Sales announced its first cross-platform addressable ad campaign, which enabled Volvo Cars to target TV viewers across DISH and Sling TV with a single buy.

09:02 EDT Global Power Equipment's services segment awarded new contracts - Global Power Equipment Group (GLPW) announced new contract awards from the Tennessee Valley Authority and the Jacksonville Electric Authority. The TVA Board of Directors authorized TVA to enter into a $950M, 5-year contract with G*UB*MK Constructors for non-nuclear modifications and supplemental maintenance. Based upon performance, there is an opportunity for an additional 5-year extension. GUBMK is an unincorporated joint venture between WorleyParsons Group Inc., Williams Plant Services, LLC, and AECOM (ACM). Williams Plant Services, LLC is a wholly-owned subsidiary of Global Power's Williams Industrial Services Group, LLC, the company's Services segment. Global Power receives 33% of the net profits generated by the joint venture. In addition, Global Power provides supervision and other services to GUBMK. This contract supersedes the contract extension that was previously announced on August 25, 2015. WISG, through its wholly-owned subsidiary Williams Industrial Services, LLC, also was awarded a contract by JEA for general construction services for fossil-fuel power generating plants. In addition, JEA communicated its intent to award a water and waste water general construction services contract to WISG's subsidiary. Each contract is for a 5-year term and valued at approximately $8M-$10M. WISG has been providing service to JEA since 1989.

08:49 EDT Georgia Power: 95% of customers impacted by Irma to be restored by Sunday night - Georgia Power announced that it expects to have service restored to 95% of customers impacted by Hurricane Irma, who can accept power, by Sunday night. The estimate is the result of a full-scale damage assessment which was completed Monday night and Tuesday as an essential step to efficiently and effectively allocate resources.

08:44 EDT Target recalls Room Essentials dressers due to tip-over, entrapment hazards - Target notified the CPSC that it is recalling about 175,000 Room Essentials 4-drawer dressers, as the recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children. In addition, about 3,000 units were sold in Canada, Target said. The firm has received 12 reports of dressers tipping or collapsing, including tipping over on two three-year-old children. No injuries have been reported.

08:40 EDT S&W Seed granted patent for stevia variety for commercial market - S&W Seed announced that the USPTO has granted S&W a patent covering its unique stevia plant variety 'SW 129.' In trials, 'SW 129' yielded over 5,000 pounds of leaf per acre per year, 98% more Reb-A content and more than a 475% increase in the Reb-A to stevioside ratio, as compared to test samples from a standard stevia variety. This is S&W's third patent granted for its unique stevia varieties. The patent for 'SW 129' will expire in 2035.

08:36 EDT RLJ Entertainment: Total digital channel subscribers surpass 600,000 mark - RLJ Entertainment announced that combined subscribers to its two proprietary digital channels, Acorn TV and Urban Movie Channel or UMC, have surpassed 600,000, an increase of 50,000 subscribers from the end of last quarter and over 60% total growth from a year ago.

08:34 EDT Rockwell Medical updates progress on Calcitriol commercial launch - Rockwell Medical provided an update on the commercial launch of Calcitriol, stating that product stability data for manufacturing approval is suitable for submission to the FDA. The company plans to submit its chemistry, manufacturing and controls, or CMC, post-approval drug manufacturing supplement to the FDA at the end of September 2017, as guided. As a result, the company anticipates Calcitriol to be commercially available in the U.S. approximately 30 days after the CMC submission, provided the FDA has no further requests. Calcitriol is Rockwell's FDA approved active Vitamin D injection for the management of hypocalcemia in patients undergoing chronic renal dialysis.

08:32 EDT T. Rowe Price reports preliminary AUM $934B at August 31 - Client transfers from mutual funds to other portfolios were $1.4B for the month-ended August 31.

08:31 EDT Fifth Third CEO sees economic growth remaining 'muted' in near-term - Sees "lower" profitability of rate increase later this year. Says assuming economic growth remains "muted" in the near-term. Says "hopeful" that real GDP growth will accelerate. Says expects to exit another $600M of commercial loans by end of this year. Says positive operating leverage a "top priority." Expects to achieve NorthStar financial targets without any meaningful benefit from broader economy or higher interest rates. Says making "solid progress" on NorthStar initiatives. Comments made by President and CEO Greg Carmichael at the Barclays Global Financial Services Conference.

08:31 EDT Immersion renews license agreement with PKG - Immersion announced that it has renewed a license agreement with PKG, Inc. Idaho-based PKG is a contract designer, developer and manufacturer of various system-level products with expertise in human-machine interfaces serving customers in the medical, industrial, government and aerospace markets. The agreement provides PKG with access to Immersion's portfolio of over 2,500 haptic patents for its touch-enabled user interface panels.

08:16 EDT Iovance Biotherapeutics announces approval for first CTA by CA in Netherlands - Iovance Biotherapeutics announced the approval of the company's Clinical Trial Application, or CTA, by the competent authority, or CA, in the Netherlands, for a Phase 2 trial of LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma. Iovance initiated the submission of CTAs in multiple countries in Europe starting in August 2017 in support of clinical trials in cervical carcinoma and metastatic melanoma.

08:07 EDT Cracker Barrel CEO says FY18 environment 'to remain challenged' - Commenting on the full fiscal year results, Cracker Barrel President and CEO Sandra Cochran said, "We ended fiscal 2017 with solid operating income margin and earnings growth. Since fiscal 2014, when we laid out our three-year strategic plan, we have grown earnings per share by nearly fifty percent, well above our target growth. As we enter the new fiscal year, we anticipate the environment to remain challenged, yet are confident in our plans to invest in the long-term growth of the Company."

08:06 EDT Mylan names Dennis Zeleny as Chief Human Relations Officer - Mylan appointed Dennis Zeleny as chief human relations officer. Zeleny served as senior vice president and chief human resources officer at Sunoco and Sunoco Logistics Partners. Previously, Zeleny was executive vice president, Administration and Services at Caremark Rx.

08:03 EDT Alibaba's Tmall becomes official partner of New York Fashion Week: The Shows - Alibaba Group's Tmall announced that it has become an official partner of New York Fashion Week: The Shows, in association with Suntchi, to help U.S. designers and brands leverage Alibaba's scale and technology to reach the China market for the first time. As part of the collaboration, Alibaba has selected designers from NYFW to be featured in Tmall's 2017 second-annual 'see-now buy-now' fashion show, a global fashion event taking place this October in the run-up to Alibaba's 11.11 Global Shopping Festival, the biggest shopping day in the world.

08:02 EDT Cracker Barrel reports Q4 comparable store restaurant sales decreased 0.8% - Including a 1.7% decrease in store traffic partially offset by a 0.9% increase in average check. The average menu price increase for the quarter was approximately 1.4%. Comparable store retail sales decreased 4.4% for the quarter. The Company opened two new Cracker Barrel stores during the quarter bringing the combined Cracker Barrel and Holler & Dash store count to 649 locations at fiscal year-end.

08:01 EDT bluebird bio announces first patient treated in expansion cohort of CRB-401 - bluebird bio (BLUE) announced that the expansion cohort of the CRB-401 Phase 1 study of bb2121, an anti-BCMA CAR T therapy, has been initiated. The objective of the CRB-401 study is to evaluate the safety and efficacy of bb2121 in patients with relapsed/refractory multiple myeloma and determine a recommended Phase 2 dose. bluebird bio and Celgene (CELG) are jointly developing bb2121. Patients in the expansion cohort will be treated at a dose range of 150 to 450 x 106 CAR+ T cells and will be required to have prior exposure to a proteasome inhibitor, an immunomodulatory agent and daratumumab.

07:36 EDT Moleculin Biotech engages CRO to begin clinical trials of WP1220 - Moleculin Biotech announced it has engaged contract research organization, or CRO, Bioscience SA to prepare for a proof-of-concept clinical trial in Poland to study its drug candidate WP1220 for the treatment of cutaneous T-cell lymphoma, or CTCL.

07:33 EDT NuVasive launches LessRay software technology system - NuVasive announced the commercial launch of its LessRay software technology system. The LessRay system, comprised of a propriety software algorithm and hardware components, is designed to help address over exposure to radiation in hospital operating rooms, particularly in the case of minimally invasive spine surgery.

07:32 EDT JetBlue says to update on operational, financial impact of Irma in coming weeks

07:31 EDT JetBlue still sees Q3 RASM down 1% to up 1% y/y - JetBlue continues to expect revenue per available seat mile, or RASM growth to range between down 1% to up 1% compared to the third quarter of 2016. RASM guidance does not include any impact of Hurricane Irma.

07:13 EDT RedHill Biopharma initiates promotion of Esomeprazole Strontium in the U.S. - RedHill Biopharma (RDHL) has initiated promotion of Esomeprazole Strontium Delayed-Release Capsules 49.3 mg in the U.S. RedHill's U.S. commercial operations are expected to pave the way for the potential future launch of RedHill's late clinical-stage GI products, if approved by the FDA. Esomeprazole Strontium DR Capsules is a product indicated for adults for the treatment of gastroesophageal reflux disease, risk reduction of NSAID-associated gastric ulcer, H. pylori eradication to reduce the risk of duodenal ulcer recurrence and for pathological hypersecretory conditions. Esomeprazole Strontium DR Capsules is a proprietary prescription drug approved by the FDA under a New Drug Application. PPIs are one of the most commonly prescribed classes of medications in the U.S., with an estimated market value exceeding $20B in 2016. RedHill has an exclusive co-promotion agreement with Concordia Pharmaceuticals, a subsidiary of Concordia International (CXRX), granting RedHill certain U.S. promotion rights for Donnatal. Under the terms of the agreement, RedHill and Concordia will share the revenues generated from the promotion of Donnatal by RedHill, based on an agreed upon split.

07:11 EDT Pluristem awarded two new patents in Hong Kong for CLI, muscle regeneration - Pluristem Therapeutics announced that the company has been issued two new patents by Hong Kong Patents Registry for its cell therapy products relating to two of the company's leading indications, Critical Limb Ischemia, or CLI, and muscle regeneration. The first patent addresses the use of mesenchymal stem cells for the treatment of skeletal muscle damage or injury. The second is for the use of adherent cells to treat ischemia and for connective tissue regeneration and repair.

07:06 EDT NV5 Global announces $60M contract with NYCDDC - NV5 Global announced that it was selected by the New York City Department of Design and Construction, or NYCDDC, to perform engineering design services for city-funded infrastructure projects for $60M. The projects will be driven by mayoral initiatives, community needs, and infrastructure rehabilitation and upgrades as determined by the DDC Commissioner and NYC agencies such as the Department of Transportation, the Department of Environmental Protection, and the Department of Parks and Recreation.

07:05 EDT Calgon Carbon awarded $2.3M water treatment contract - Calgon Carbon Corporation announced that the company and RC Foster Corporation have signed a system supply contract valued at $2.3M, under which Calgon Carbon will provide granular activated carbon and associated equipment systems for the removal of 1,2,3-Trichloropropane from groundwater in the city of Chino, CA. Under the terms of the contract, Calgon Carbon will supply a total of 16 GAC adsorption vessels and 320,000 pounds of Filtrasorb 400 GAC to the Benson Treatment Plant and the Eastside Treatment Plant. The systems will treat up to 5M gallons of water per day at each site.

07:04 EDT Abbott says FreeStyle Libre system now available for reimbursement in UK - Abbott announced that the FreeStyle Libre system is now available for reimbursement in the United Kingdom. The National Health Service Business Services Authority has approved the listing on the Drug Tariff for the FreeStyle Libre system for people with diabetes using insulin. This means that from Nov. 1, 2017 it will be available for reimbursementiii via the NHS across England and Wales, NHS Scotland, and the Health and Social Care in Northern Ireland.

07:03 EDT AVEO Oncology receives payments from EUSA Pharma, CANbridge - AVEO Oncology announced the receipt of a $4M research and development payment from EUSA Pharma related to the approval of FOTIVDA for the treatment of adult patients with advanced renal cell carcinoma in Europe, and a $0.5M milestone payment from CANbridge related to manufacturing development activities for AV-203, AVEO's clinical-stage ErbB3 inhibitory antibody candidate.

07:03 EDT GTx: Daily dose of enobosarm 3mg improved SUI in women in Phase 2 trial - GTx, Inc. announced top-line clinical trial results demonstrating that a daily dose of enobosarm 3 mg -- GTx-024 -- substantially improved stress urinary incontinence in women, as well as related quality of life measurements. In this open-label clinical trial, all 17 patients completing 12 weeks of treatment saw a clinically significant reduction in stress leaks per day, compared to baseline. Mean stress leaks decreased by 83 percent from baseline over 12 weeks, and the reductions in daily stress leaks following completion of treatment have been sustained as patients are being followed for up to 7 months post-treatment to assess the durability of treatment effect. No patient has relapsed to her baseline levels. These results were presented at the International Continence Society (ICS) Annual Meeting currently being held in Florence, Italy from September 12-15, 2017. The podium presentation entitled "Kegels In A Bottle": Preliminary Results Of A Selective Androgen Receptor Modulator For The Treatment Of SUI In Post-Menopausal Women, summarized clinical data from the first 17 patients completing 12 weeks of enobosarm treatment, including the duration of response for up to 7 months following completion of enobosarm treatment. In this trial, a total of 19 post-menopausal women were enrolled by three clinical sites to receive enobosarm treatment. In addition to the 17 patients who completed treatment, another will complete treatment in approximately 8 weeks and one patient previously withdrew consent shortly after her initial visit. Data highlights were as follows: Each of the women treated with enobosarm showed a clinically significant reduction in incontinence episodes per day: Mean stress leaks decreased by 83% percent from baseline over 12 weeks; Stress leaks decreased from a mean of 5.08 leaks/day at baseline, to 0.88 leaks/day at Week 12; All 17 patients achieved the primary endpoint of reductions in leaks per day, compared to baseline, of at least 50% at Week 12.

06:57 EDT Teekay Corp. announces changes to board of directors - Teekay Corporation announced changes to its Board of Directors: Axel Karlshoej, Director and Chairman Emeritus, and Thomas Kuo-Yuen Hsu, Director, have retired from their positions effective September 12, after 25 years with the Company's Board. Karlshoej and Hsu are being replaced by Rudolph W.J. Krediet and Heidi Locke Simon. In addition, David Schellenberg has been appointed to the company's board. Since 2013, Krediet has served as a Partner at Anholt Services, a wholly-owned subsidiary of the Kattegat Trust, which oversees the Trust's globally-diversified investment portfolio.

06:51 EDT Juno Therapeutics treatment of follicular lymphoma granted FDA orphan status - Juno Therapeutics' treatment of follicular lymphoma was granted FDA orphan status, according to a post to the agency's website. Reference Link

06:32 EDT Delcath Systems to switch trading to OTCQB - Delcath Systems has approved the voluntary delisting from NASDAQ. As a result of the shareholder non-approval of its reverse stock split, the company does not meet the requirements for continued listing on the Nasdaq Capital Market. The company expects that its common shares will cease trading on NASDAQ on or about September 22. In preparation for this contingency, the company has applied for listing on the OTCQB and anticipates that its stock will begin trading there on September 22 under the symbol "DCTH".

06:15 EDT VTTI Energy holders approve merger with VTTI B.V. - VTTI Energy Partners LP announced that at a special meeting of the Partnership's unitholders held earlier today, the unitholders voted to adopt the Agreement and Plan of Merger, dated as of May 8, by and among the Partnership, VTTI B.V., VTTI Energy Partners GP LLC, the general partner of the Partnership, VTTI MLP Partners B.V. and VTTI Merger Sub LLC, wholly owned subsidiaries of VTTI, pursuant to which VTTI will become an indirect wholly owned subsidiary of VTTI. Approximately 98.75% of the Partnership's common units and 100% of the Partnership's subordinated units voted at the special meeting voted in favor of the adoption and approval of the Merger Agreement and the transactions contemplated thereby. The votes in favor of the Merger Agreement constituted a majority of the Partnership's common units, other than common units held by VTTI MLP Partners B.V. and by Stichting Administratiekantoor VTTI that do not correspond to a vested depositary receipt issued to an employee, consultant or director of VTTI or its affiliates, and a majority of the VTTI subordinated units outstanding as of the record date of the special meeting, as required for adoption and approval of the Merger Agreement. The merger is expected to close on September 15, 2017.

06:05 EDT Amicus: Phase 3 SD-101 study did not meet primary, secondary endpoints - Amicus Therapeutics reported that top-line data from the randomized, double-blind, placebo-controlled Phase 3 clinical study to assess the efficacy and safety of the novel topical wound-healing agent SD-101 did not meet the primary endpoints or secondary endpoints in participants with epidermolysis bullosa. The Phase 3 ESSENCE study randomized 169 participants with a documented diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz epidermolysis bullosa to SD-101 (n=82) or placebo (n=87) during a three-month primary treatment period. SD-101 did not show a statistically significant difference from placebo in the intent to treat population (n=169). The first primary endpoint, the time to target wound closure within 3 months, was not different between groups (Hazard ratio=1.004, p=0.985).1 The second primary endpoint, the percentage of patients achieving target wound closure by month 3, was also not different between groups (49% SD-101; 54% placebo; p=0.390).2 Similarly, the secondary endpoints did not reach statistical significance versus placebo. Encouraging trends in wound closure were observed in certain sub-populations. Treatment-emergent adverse events were similar across both the SD-101 and placebo groups. The most common TEAEs were nasopharyngitis, pruritis, and pyrexia. Amicus plans to further analyze and share the Phase 3 ESSENCE results with key stakeholders in the epidermolysis bullosa community including physicians, patient organizations and regulators. In the interim, in consultation with their physicians, participants in the ongoing extension studies (SD-004 and -006) will have the opportunity to continue being treated with SD-101. Based on these top-line data Amicus has no current plans to invest in any additional clinical studies or commercial preparation activities for SD-101.

06:02 EDT Harris awarded contract for up to $70M by U.K. Ministry of Defence - Harris has been awarded a contract worth up to GBP55M, or $70M, by the U.K.'s Ministry of Defence, to provide T7 robotic systems to support U.K. explosive ordnance disposal missions around the world.

06:02 EDT BlackBerry, Timex group enter patent license agreement - BlackBerry and Timex Group announced they have entered into a patent license agreement. The financial structure of the deal includes on-going royalty payments from Timex to BlackBerry. Additional terms of the agreement are confidential.

06:00 EDT WhatsApp co-founder Brian Acton leaving to start non-profit - WhatsApp co-founder Brian Acton said in a Facebook post that "After 8 years at WhatsApp, I have decided to move on and start a new chapter in my life. I am very fortunate at my age to have the flexibility to take new risks and focus on what I'm passionate about. I've decided to start a non-profit focused at the intersection of nonprofit, technology and communications. It's something I've thought about for a while, and now it's time to just focus and execute. I'll have more to share in the coming months. This decision is, of course, a tough one. I'm proud of what our team has accomplished in only a few years, and it's humbling to see that so many people rely on WhatsApp every day." Reference Link

05:56 EDT Kay Matadi to join Twitter as head of content partnerships - Kay Madati tweeted, "Excited to join @Twitter (TWTR) as head of content partnerships & to work with @anthonynoto + other amazing leaders." Matadi previously served as EVP and Chief Digital Officer at Viacom's (VIAB) BET Networks. Reference Link

05:54 EDT Novartis: Phase III data shows Cosentyx delivered long-lasting skin clearance - Novartis announced first of its kind Phase III data showing Cosentyx delivered high and long-lasting skin clearance in patients with moderate-to-severe plaque psoriasis at 5 years. These data were presented for the first time at the 26th European Academy of Dermatology and Venereology, or EADV, Congress in Geneva, Switzerland. By specifically targeting interleukin-17A, or IL-17A, Cosentyx addresses the key cytokine involved in the development of psoriasis. IL-17A plays a significant role in the pathogenesis of plaque psoriasis, psoriatic arthritis, or PsA, and ankylosing spondylitis. Inhibiting IL-17A is important as up to 30% of patients with psoriasis may have PsA.

05:45 EDT Amazon says no front-runners yet on new city for headquarters - After Bloomberg reported that the company is weighing Boston as the city for its second headquarters, Amazon.com tweeted, "Bloomberg is incorrect - there are no front-runners at this point. We're just getting started & every city is on equal playing field." Amazon added, "We're energized by the response from cities across NA who have already reached out to express interest in participating in the HQ2 RFP."

05:41 EDT Duke Energy restores power to 160k customers in NC, SC after Hurricane Irma - Duke Energy expects to restore power to almost all North Carolina and South Carolina customers by late Friday, if not sooner, in the wake of Tropical Storm Irma.The company so far has restored power to 160,000 customers in both states. In North Carolina's Piedmont area, including Charlotte, almost all customers can expect to have power restored by 11 p.m. Thursday, though 95 percent will be restored sooner. In the North Carolina mountains and Upstate South Carolina, customers can expect to have power restored by 11 p.m. Friday. However, 95 will be restored sooner.

05:26 EDT Georgia Power says power restored to 405k customers following Hurricane Irma - Electric service to nearly 1M Georgia Power customers was impacted at the height of Hurricane Irma and, 24 hours later, Georgia Power has restored power to more than 405,000 customers across the state. As of 6:30 p.m. Tuesday, approximately 545,000 customers are without power across Georgia. While the company is working around the clock, customers should plan ahead for the potential for extended outages, possibly days or weeks, due to the vast damage from the storm. Regional and statewide restoration estimates will be available as soon as assessment is completed. Damage assessment following widespread destruction from Hurricane Irma is in progress throughout Georgia and must be completed as an essential step to efficiently and effectively allocate resources. During assessment and restoration, Georgia Power must wait until conditions are safe for crews to begin power restoration and additional heavy rain or high winds may impact efforts. Additional challenges faced following the storm include downed trees, blocked roads and bridges that must be inspected by the state following flooding. Restoration progress since the beginning of the storm has been largely possible thanks to Georgia's advanced electric grid, which allows the company to reroute and restore power even when weather conditions prevent work in the field, as well as early work of crews. All of Georgia Power's teams are in the field today working to assess damage and restore power. Georgia Power is the largest electric subsidiary of Southern Company.