Stockwinners Market Radar for September 21, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

CDTI

Hot Stocks

18:15 EDT CDTi sees September 21 as effective date of reverse stock split - CDTi Advanced Materials announced the expected effective date of its 1-for-5 reverse stock split. Stockholders granted the board of directors discretionary authority to effect the reverse split at the company's annual meeting of stockholders held on August 24, 2018. CDTi anticipates the reverse split to be effective after the close of trading on NASDAQ on Friday, September 21, 2018, and for the common stock to continue trading on NASDAQ under the trading symbol "CDTI" under new CUSIP number 12514V204 on a split-adjusted basis commencing at the open of trading on Monday, September 24, 2018. The reverse split will reduce the number of outstanding shares of CDTi common stock from approximately 20 million shares to approximately 4 million shares. Correspondingly, the trading price of CDTi common stock is expected to proportionately increase immediately following the Effective Date. The company will not issue any fractional shares resulting from the reverse split. Instead, any stockholder who would otherwise be entitled to less than one full share of CDTi common stock will receive a cash payment for such fractional share at a rate equal to the average of the closing prices per share of CDTi common stock on NASDAQ over the five trading days immediately preceding the Effective Date.
DUK

Hot Stocks

18:08 EDT Duke Energy restored nearly 1.8M outages in NC, SC during past week - Duke Energy crews today focused on the remaining 26,000 customers without power as of 4:30 p.m., after restoring nearly 1.8M outages in North Carolina and South Carolina during the past week in the aftermath of Hurricane Florence. Duke Energy expects to restore power to 99% of customers whose properties are able to receive power by Sunday at 11:45 p.m.
JNJ

Hot Stocks

18:01 EDT Johnson & Johnson's Janssen discloses phase 3 study results of Esketamine - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from a Phase 3 clinical study of the investigational product esketamine nasal spray in patients with treatment-resistant depression. Janssen researchers presented these results at the Ninth Biennial Conference of the International Society for Affective Disorders (ISAD) and the Houston Mood Disorders Conference, taking place September 20-22, 2018 in Houston, TX. This clinical trial was a randomized, double-blind study of two fixed doses of esketamine, 56 mg and 84 mg. The study did not demonstrate statistical significance for the primary endpoint, change in a depression severity rating scale score from baseline to four weeks, for esketamine 84 mg plus oral antidepressant compared to oral antidepressant plus placebo. Therefore, based on the prespecified analysis plan, the esketamine 56 mg plus oral antidepressant group could not be formally evaluated in this study. Importantly, results of analyses of the primary endpoint and key secondary endpoints numerically favored both esketamine plus oral antidepressant treatment groups over the oral antidepressant plus placebo group.
CB

Hot Stocks

17:22 EDT Chubb CEO Greenberg sells $8.6M in common stock - Chubb CEO Evan Greenberg disclosed in a filing that he had sold 61.4K shares of company stock on September 19. The total transaction value was about $8.6M.
VTVT

Hot Stocks

17:21 EDT vTv says FDA advised that azeliragon efficacy be shown in at least 2 trials - According to a regulatory filing, on September 17, 2018, vTv Therapeutics Inc. received a written response from the FDA to its Type C Meeting Request seeking development guidance for azeliragon. In the response, the FDA advised that the efficacy of azeliragon should be demonstrated in at least two adequate and well-controlled trials, unless under the exceptional circumstances in which a single trial might suffice as set forth in the FDA's guidance document entitled "Providing Clinical Effectiveness for Human Drug and Biological Products." The company continues to assess all options for the continued development of azeliragon.
VYGR

Hot Stocks

17:17 EDT Armistice Capital reports 5.3% passive stake in Voyager Therapeutics
GNRC

Hot Stocks

17:16 EDT Generac announces new $250M share repurchase program - The company announced that its Board of Directors has authorized a new stock repurchase program, which will commence subsequent to the expiration of the previously announced company stock repurchase program that is due to expire on October 26, 2018. Under the newly authorized stock repurchase program, the company may repurchase up to $250M of its common stock over a 24 month period, commencing October 27, 2018.
HRS

Hot Stocks

17:13 EDT Harris awarded $255.4M Department of Defense contract - Harris Corp has been awarded a maximum $255,421,604 fixed-price, requirements contract for B-52 and C-130 Special Operation Forces aircraft parts. This is a seven-year contract with no option periods. This was a sole-source acquisition using justification 10 U.S. Code 2304(c)(1), as stated in Federal Acquisition Regulation 6.302-1. Location of performance is New Jersey with a May 24, 2026, performance completion date.
PMBC

Hot Stocks

17:10 EDT FJ Capital Management reports 5.7% passive stake in Pacific Mercantile Bancorp
DTEA

Hot Stocks

17:09 EDT TDM Asset Management reports 9.1% passive stake in DAVIDsTEA
NYT EXPE

Hot Stocks

17:08 EDT Expedia president Bhutani joins New York Times board - The New York Times Company (NYT) announced today that Aman Bhutani, President of the Brand Expedia Group (EXPE) at Expedia Group, Inc., has been appointed to its Board of Directors. In his present role at Expedia, which he has held since 2015, Mr. Bhutani runs all global business operations of the Brand Expedia Group including the Expedia brand globally and a set of regional brands including Travelocity, Orbitz, Cheaptickets, eBookers and Wotif. Prior to this role, he was Brand Expedia Group's chief technology officer and senior vice president of worldwide engineering, where he was well-known for having established a data-driven culture, based in the scientific method, among the group's global technology team. He's an eight year veteran of Expedia Group, Inc.
EPRT

Hot Stocks

16:45 EDT Integrated Core Strategies reports 6.3% passive stake in Essential Properties Realty Trust
BBSI

Hot Stocks

16:43 EDT SEC says Barrett Business to pay $1.5M penalty over improper accounting - The Securities and Exchange Commission yesterday charged the former chief financial officer of Barrett Business Services Inc. for his role in an accounting fraud involving BBSI's workers' compensation expenses. The SEC also charged BBSI in the accounting fraud and charged the company's former controller for his role in improperly approving certain of the CFO's accounting entries. Both BBSI and the former controller agreed to settle the Commission's charges against them. The SEC's complaint against BBSI's former CFO James D. Miller, filed in federal district court in the Western District of Washington, alleges that Miller manipulated BBSI's accounting records to hide the fact that its workers' compensation expense was increasing relative to its revenue. According to the complaint, Miller took steps to conceal from BBSI's independent auditor a third-party actuarial report concluding that BBSI needed to add tens of millions of dollars to its workers' compensation liability. BBSI's stock dropped 32 percent when the Vancouver, Washington-based firm announced it needed to restate its financial results to reflect increased workers' compensation expenses. In a parallel action, the U.S. Attorney's Office for the Western District of Washington announced criminal charges against Miller. The SEC instituted a settled administrative proceeding against BBSI for violations of the antifraud, books and records, internal accounting controls, and reporting provisions of the federal securities laws, and former Controller Mark Cannon for books and records violations. Without admitting or denying the SEC's findings, BBSI agreed to pay a $1.5 million civil penalty and Cannon agreed to pay a $20,000 civil penalty and to be suspended from appearing and practicing before the Commission as an accountant, which includes not participating in the financial reporting or audits of public companies. The SEC's order permits Cannon to apply for reinstatement after one year. BBSI CEO Michael Elich, who was not charged by the SEC, has reimbursed the company for $20,800 in cash bonuses he received during the period of the alleged accounting violations.
EMCF

Hot Stocks

16:36 EDT Emclaire Financial announces shareholder, regulatory approval of merger - Emclaire Financial and Community First Bancorp announced that the shareholders of Community First approved and adopted the agreement and plan of merger providing for the merger of Community with and into Emclaire at a special meeting of shareholders. In addition, all required regulatory approvals for completion of the merger have been obtained. The merger is expected to be completed on or about October 1, subject to satisfaction of customary closing conditions. Under the terms of the merger agreement, Community First will merge with and into Emclaire and immediately thereafter Community First Bank will merge with and into Farmers National. Shareholders of Community First will receive 1.2008 shares of Emclaire common stock and $6.95 in cash for each share of Community First common stock upon completion of the merger. In addition, each share of preferred stock of Community First Bank will be exchanged for similar shares of preferred stock of Emclaire. Following completion of the merger, the two banking companies will create a bank with approximately $900M in total assets providing banking services through 20 locations throughout Western Pennsylvania and in Hancock County, West Virginia. The transaction will strengthen Emclaire's presence in Clarion and Jefferson counties, Pennsylvania.
IDA

Hot Stocks

16:31 EDT IDACORP raises quarterly dividend 6.8% to 63c per share - IDACORP announced that its Board of Directors approved an increase in the regular quarterly cash dividend on IDACORP's common stock of 6.8% to 63c per share. At the new rate, the indicated dividend is $2.52 per share on an annual basis.
NSEC

Hot Stocks

16:01 EDT National Security Group sees losses from Hurricane Florence of $1M-$1.5M - The National Security Group released estimates of reported catastrophe losses from Hurricane Florence incurred by property and casualty subsidiary National Security Fire & Casualty Company. "Based on management's analysis of historical reporting patterns, preliminary post event model output and assessment of early reports of claims to date, we estimate our ultimate gross losses from Hurricane Florence to be in the range of $1,000,000 to $1,500,000. We expect losses, net of tax, from Hurricane Florence to reduce our third quarter and year-to-date earnings in the range of $790,000 ($0.31 per share) to $1,185,000 ($0.47 per share). We maintain catastrophe reinsurance that provides coverage from a catastrophe event up to $72.5 million subject to a $4 million per event retention. We also prepay reinstatement premium protection which provides additional coverage for a subsequent event that exceeds the $4 million per event retention level. Based on estimates outlined above, we do not expect losses from Hurricane Florence to exceed our per event retention level under our catastrophe reinsurance program."
TWTR

Hot Stocks

15:58 EDT Twitter addresses bug that could have resulted in data going to wrong developer - In a blog post, Twitter stated: "We recently published a notice about a bug related to our Account Activity API that could have resulted in data being delivered to the wrong registered developer. As part of our ongoing investigation, we have already emailed all developers who may have been impacted, and want to provide some additional details to potentially affected developers here. So far, our investigations have confirmed only one set of technical circumstances where this issue could have occurred...Our team has been working diligently with our most active enterprise data customers and partners who have access to this API to evaluate if they were impacted. Through our work so far, and the information made available to us by our partners, we can confirm that the bug did not affect any of the partners or customers with whom we have completed our review. Over the coming days, we will continue our investigations to include a review of our remaining enterprise partners who could have been impacted." Reference Link
AAPL

Hot Stocks

15:47 EDT Apple says earlier issues with App Store, iTunes Store resolved - Apple, which said earlier on its System Status page that some users were experiencing a problem with the App Store and iTunes Store services, now says those issues are resolved. Reference Link
BA

Hot Stocks

15:42 EDT Boeing delivers first 787 Dreamliner for Shanghai Airlines - Boeing and Shanghai Airlines today celebrated the delivery of the carrier's first 787-9 Dreamliner. The airline says it plans to use the super-efficient and passenger-preferred Dreamliner to upgrade its regional and long-range service from its base in China's largest city. The 787-9 is the second member of the Dreamliner family, which offers 20 to 25 percent better fuel efficiency per seat and lower emissions than the airplanes they replace. As the longest-range member of the family, the 787-9 can fly 290 passengers, in a typical two-class configuration, up to 7,635 nautical miles (14,140 km). Shanghai Airlines is set to receive additional 787-9s in the coming years. The airline plans to fly their initial 787s on popular domestic routes such as Shanghai to Chengdu and Beijing, as well as regional routes from Shanghai to Japan and Korea. As the carrier's 787 fleet grows, it plans to take advantage of the aircraft's long range and superior fuel efficiency to open new, international routes.
BX KKR

Hot Stocks

15:27 EDT Blackstone president says still studying possible shift to C-Corp - In interview earlier on CNBC, Blackstone (BX) president Jon Gray said the message delivered at Blackstone's investor day meeting was that "the firm is in terrific shape, driven by great performance." He added: "We told folks earnings are going to be accelerating going forward. Not only will they be accelerating, the nature of those earnings is changing. The way they're changing is, as we move more and more to longer duration vehicles, what we call perpetual capital, we get more fee related earnings, more predictable earnings. We think the combination of faster earnings growth, more predictable earnings, steadier earnings, will give the opportunity for a re-rating of our stock." Asked about his stock trading at a discount to KKR (KKR), which has opted to become a C-Corp, Gray said: "We've definitely seen what's happened to their stock and others, and we've been impressed. We're looking at it closely. We said, I think, on the board, actively considering this is an important decision. We want to be thoughtful. We'd like to see sustained stock price performance. We'd like to see what happens in index inclusion. We'd like to see in terms of mutual fund ownership. It is something we're open to, but we're still studying." Reference Link
PYPL

Hot Stocks

14:44 EDT PayPal confirms ending business relationship with Infowars - In a blog post, PayPal confirmed that it is ending its business relationship with Infowars and its related websites. "We understand this decision will be controversial to some," the company said. "As a company, we take seriously our responsibility to ensure that our values are at the core of everything we do, and we will take action to stand for our values. We do not take these actions lightly and we work hard to be rigorous and fair-minded. We undertook an extensive review of the Infowars sites, and found instances that promoted hate and discriminatory intolerance against certain communities and religions that run counter to our core value of inclusion. We believe that hatred and discrimination have no place in our democratic society and, we do not support this conduct." Reference Link
OSTK

Hot Stocks

14:39 EDT Law firm says Overstock.com loses Delaware trial over gift cards - Law firm Grant & Eisenhofer announced that it won a jury verdict on behalf of a whistleblower who exposed a scheme by Overstock.com to avoid reporting and remitting to Delaware millions of dollars in dormant gift cards. A 12-person jury found that Overstock failed to report and remit unredeemed gift card balances that by law should have been reported to the State of Delaware as unclaimed property. As a result, Overstock was found to have violated Delaware's False Claims and Reporting Act over a four-year period of 2010-13. The unanimous verdict was handed down on September 20, according to a press release from the firm. The aggregate amount of unreported gift card balances was just under $3M - under terms of Delaware's whistleblower statute, Overstock is liable for treble damages plus statutory fines and attorneys' fees. Total damages will be determined by presiding Superior Court Judge Paul R. Wallace, according to Grant & Eisenhofer.
EDNT

Hot Stocks

14:16 EDT Louis Foreman reports 5.78% passive stake in Edison Nation
AAPL

Hot Stocks

13:29 EDT Apple says some users reporting issues with App Store, iTunes Store - In posts to its System Status page, Apple indicates that some esers are experiencing a problem with the App Store and iTunes Store services. "We are investigating this issue," the company states on the status page.
BHGE

Hot Stocks

13:02 EDT Baker Hughes reports U.S. rig count down 2 to 1,053 rigs - Baker Hughes reports that the U.S. rig count is down 2 rigs from last week to 1,053, with oil rigs down 1 to 866, gas rigs unchanged at 186, and miscellaneous rigs down 1 to 1. The U.S. Rig Count is up 118 rigs from last year's count of 935, with oil rigs up 122, gas rigs down 4, and miscellaneous rigs unchanged at 1. The U.S. Offshore Rig Count is unchanged at 20 rigs and up 1 rig year-over-year. The Canada Rig Count is down 29 rigs from last week to 197, with oil rigs down 13 to 135 and gas rigs down 16 to 62. The Canada Rig Count is down 23 rigs from last year's count of 220, with oil rigs up 13 and gas rigs down 36.
MDXG

Hot Stocks

12:42 EDT MiMedx trading resumes
MDXG

Hot Stocks

12:37 EDT MiMedx trading halted, volatility trading pause
DUK

Hot Stocks

12:26 EDT Duke Energy confirms cooling pond water flowing into Cape Fear River river - Duke Energy confirmed that Cape Fear River flooding conditions at the company's L.V. Sutton plant in Wilmington, N.C. have caused breaches in the cooling lake dam surrounding the cooling lake and caused the company to shut down the 625-megawatt natural gas plant there. The rising river continues to overtop the north end of the cooling lake dam, a surface that is protected by a layer of compacted soil and cement. Water is now exiting the cooling lake through breaches - one large and several smaller - on the southern end of the impoundment. The cooling lake water also flowed into the natural gas plant footprint. There are two coal ash basins at the site. The company believes that ash in the 1971 ash basin remains in place behind a steel wall separating the excavation area from the cooling lake. That wall is submerged by flood water, but the earthen portion of the basin dam is about two feet above water and stable. There is no visible ash in the cooling lake, and prior to flooding the ash level was at least five feet below the top of the steel wall. Cenospheres are moving from the 1971 ash basin to the cooling lake and into the Cape Fear River. Cenospheres are lightweight, hollow beads comprised of alumni and silica that are a byproduct of coal combustion. Water is more than 10 feet from the earthen dike of the 1984 basin. It is stable and has not been affected. The lined landfill, where most of the site's ash is disposed, has not been affected by the cooling lake and repairs from the hurricane are underway. Site personnel are supplementing on-site supplies with large stone and other materials, engineering experts are moving to the site and personnel continue to develop and activate repair plans. Given the historic level of flooding on the river, there is little to no chance that cooling lake water will contribute to a measurable change to water levels in the area. Sutton Lake is an 1,100-acre man-made reservoir constructed in 1972 to supply cooling water to the Sutton power plant. The cooling lake does not store coal ash.
MTL

Hot Stocks

12:00 EDT Mechel falls -8.8% - Mechel is down -8.8%, or -30c to $3.12.
VRTV

Hot Stocks

12:00 EDT Veritiv falls -12.0% - Veritiv is down -12.0%, or -$5.35 to $39.35.
REV

Hot Stocks

12:00 EDT Revlon falls -13.2% - Revlon is down -13.2%, or -$3.20 to $21.00.
BE

Hot Stocks

12:00 EDT Bloom Energy rises 8.1% - Bloom Energy is up 8.1%, or $2.44 to $32.45.
YRD

Hot Stocks

12:00 EDT Yirendai rises 9.0% - Yirendai is up 9.0%, or $1.71 to $20.64.
SCS

Hot Stocks

12:00 EDT Steelcase rises 15.2% - Steelcase is up 15.2%, or $2.46 to $18.61.
WIRE

Hot Stocks

11:46 EDT Encore Wire reports antidumping and countervailing duty petition filing - Encore Wire announced that it had signed on to antidumping and countervailing duty petitions filed with the U.S. Department of Commerce and the U.S. International Trade Commission to address imports of illegally dumped and subsidized aluminum wire from China. The petitions "describe how surging volumes of Chinese aluminum wire are being unfairly traded and injuring American manufacturers and workers," the company stated. The petitions cover Chinese aluminum building wire used in residential, commercial, and industrial applications. In the weeks that follow, the U.S. Department of Commerce will decide whether to formally initiate unfair trade investigations. Such investigations typically take approximately one year to complete, Encore said.
CMCSA...

Hot Stocks

11:22 EDT Box Office Battle: 'House with a Clock in its Walls' seen to win the weekend - The major release opening this weekend is Universal Pictures' (CMCSA) "The House with a Clock in Its Walls," a children's fantasy film starring Jack Black and Cate Blanchett. The movie, which already grossed $840,000 in Thursday night previews, is expected to win the weekend at the box office with a domestic gross of $18M-$21M. The other major release is Michael Moore's "Fahrenheit 11/9," a political documentary about the 2016 U.S. presidential election. The film is anticipated to end the weekend as the fifth highest grossing movie, bringing in about $6M-$8M. Second place at the box office is forecast to go either Lionsgate's (LGF.A) thriller "A Simple Favor" or Warner Bros.' (T) "The Nun," which are both expected to domestically gross about $9.1M. Meanwhile, Fox's (FOXA) action film "The Predator," which took first place at the box office last weekend, is expected to end this weekend in fourth place with a domestic gross of about $8.4M. Other publicly traded companies in filmmaking include Disney (DIS), Sony (SNE), and Viacom (VIA, VIAB).
DTEA

Hot Stocks

11:19 EDT DAVIDsTEA says 'not aware' of reasons for recent market activity - In light of the recent significant increase in the price of its shares and in trading volume, DAVIDsTEA Inc. wishes to confirm that it is not aware of any corporate development or other reason for the recent market activity.
MU INTC

Hot Stocks

11:14 EDT Micron slides as analysts debate if guidance a sign of downturn - Shares of Micron (MU) are falling after the company reported "solid" fourth quarter results, but missed expectations for its Q1 guidance and company executives said U.S. tariffs on China goods would impact its financial results for as much as one year. EARNINGS AND GUIDANCE: On Thursday after the market close, Micron reported Q4 earnings per share of $3.53 on revenue of $8.44B, which compared to analyst estimates of $3.34 and $8.25B, respectively. Micron also guided to Q1 EPS of $2.95, plus or minus 7c, on revenue in the range of $7.9B-$8.3B. This compares to analyst estimates of $3.06 and $8.44B, respectively. The company said on its earnings conference call that its gross margins will be impacted in the near term by the announced 10% tariff on $200B of imports from China, which will go into effect on September 24. CFO David Zinsner commented that "Clearly, tariffs are impacting us, probably to the tune of 50 to 100 basis points...We are working on steps to mitigate that. That obviously takes some time." "We are working to gradually mitigate most of the impact from these tariffs over the next three to four quarters," Micron added. ANALYST REACTIONS: On Thursday, Evercore ISI analyst C.J. Muse lowered his price target on Micron to $80 from $100, saying that while the softening demand from hyperscale customers was a known headwind, the "negative implications" of tariffs and Intel (INTC) CPU shortages were a new development. The analyst also cites "very little commentary" from the company related to the expected duration of the cloud inventory adjustment. Muse expects softness in the DRAM prices to possibly persist through 2Q19 when the slowdown in pricing will decelerate. On Friday, Morgan Stanley analyst Joseph Moore said he was surprised at the magnitude of the upside Micron reported, but it guided revenues to be down in the strongest seasonal quarter validating some of his recent concerns. While demand factors such as Intel shortages and a few limited inventory adjustments seem "narrow and temporary," the industry "almost certainly will" build inventory in the strongest seasonal quarter, which will have the effect of adding to supply for the seasonally weaker period in early 2019, contended Moore. While there remains debate about what cyclical concerns are already priced in, "this is how memory downturns begin," he said. Moore kept an Equal Weight rating on Micron shares and lowered his price target to $48 from $65. Meanwhile, JPMorgan analyst Harlan Sur views the company's guidance as conservative, saying management has consistently delivered financial results above the midpoint of guidance or above the guided range over the past few years. Further, Sur expects broader supply/demand memory fundamentals to remain in relative balance and believes demand for memory will remain "strong and broad-based." The analyst lowered his price target for Micron shares to $75 from $84 and kept an Overweight rating on the name. In addition, Deutsche Bank analyst Sidney Ho said that while the company reported "solid" results, its guidance missed expectations for the first time in two years. The outlook came with a few negative surprises, namely inventory adjustments, CPU shortages and tariffs on imported goods from China, Ho said. The analyst expects Micron shares to "remain choppy given no clear winner between the bulls and bears." However, at the current valuation, Ho views Micron's risk/reward as favorable. PRICE ACTION: Micron dropped 3.5% to $44.48 in late morning trading.
PLX

Hot Stocks

11:10 EDT Protalix trading resumes
WLDN

Hot Stocks

11:07 EDT NYPA selects Willdan Group for Energy Savings Performance Contracting - Willdan Group announced that the New York Power Authority has selected Willdan as an implementer for its expansion of New York State's BuildSmart NY Program. This contract expands Willdan's reach to New York public facilities by allowing Willdan to implement Energy Savings Performance Contracting projects under NYPA in all areas of the state. The program includes both energy efficiency measures and the implementation of innovative energy solutions such as solar photovoltaic, hybrid, and cogeneration systems; microgrids; and other emerging technologies. The BuildSmartNY five-year contracts have a shared ceiling of $200M.
PLX

Hot Stocks

11:01 EDT Protalix reports 'positive' preliminary data from Fabry Disease study - Protalix BioTherapeutics announced "positive" preliminary data from the BRIDGE study of pegunigalsidase alfa for the treatment of Fabry disease, stating that additional data will be released at the 1st Canadian Symposium on Lysosomal Diseases 2018. Preliminary data from the first sixteen patients enrolled in the trial demonstrated an improvement in kidney function when switched from agalsidase alfa to pegunigalsidase alfa, the company said. Based on available historical serum creatinine and study 3 month screening period values for approximately 2 years while treated with agalsidase alfa before switching to pegunigalsidase alfa treatment, the annualized estimated glomerular filtration rate slope for patients on Replagal was -6.8ml/min/1.73m. The mean eGFR slope for the same patients following six months of treatment with pegunigalsidase alfa was changed to be +3.7ml/min/1.73m , these results were statistically significant. Baseline characteristic of these patients were: mean estimated glomerular filtration rate 75.40 and 86.03 mL/min/1.73m2 for males and females, with annualized eGFR slope of -8.0 and -5.1 mL/min/1.73m2/year, respectively.
PLX

Hot Stocks

10:51 EDT Protalix trading halted, news pending
SGEN TKPYY

Hot Stocks

10:50 EDT Seattle Genetics announces Adcetris approval in Japan - Seattle Genetics (SGEN) announced that its collaborator, Takeda (TKPYY), has received approval from the Japanese Ministry of Health, Labour and Welfare for ADCETRIS in combination with doxorubicin, vinblastine and dacarbazine as a frontline treatment option for CD30-positive Hodgkin lymphoma patients in Japan. As a result, Seattle Genetics will receive a milestone payment from Takeda of $10M. The approval in Japan was based on the positive outcome from the phase 3 ECHELON-1 trial. Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. Seattle Genetics is entitled to receive progress- and sales-dependent milestone payments. In addition, Seattle Genetics receives tiered double-digit royalties with percentages ranging from the mid-teens to mid-twenties based on net sales of ADCETRIS within Takeda's territories.
CTAS

Hot Stocks

10:20 EDT Cintas to construct new facility in Delta Charter Township - Cintas Corporation is constructing a new facility in Delta Township. The new Cintas facility will be a 55,000 square-foot laundry operation that will add approximately 60 jobs in sales, skilled, technical and office operations. The company will begin hiring for positions in the Fall of 2019.
NBEV

Hot Stocks

10:14 EDT New Age Beverages trading resumes
NBEV

Hot Stocks

10:04 EDT New Age Beverages trading halted, volatility trading pause
ADT

Hot Stocks

10:00 EDT ADT Inc. rises 7.5% - ADT Inc. is up 7.5%, or 67c to $9.59.
NEW

Hot Stocks

10:00 EDT Puxin Limited rises 9.5% - Puxin Limited is up 9.5%, or 79c to $9.10.
SCS

Hot Stocks

10:00 EDT Steelcase rises 15.6% - Steelcase is up 15.6%, or $2.53 to $18.68.
BTC...

Hot Stocks

09:57 EDT The Intersection: Crypto and Wall Street This Week - As bitcoin, ethereum and other cryptocurrencies get increasing attention from investors, Wall Street and its traditional banks continue to adjust to the shift. Catch up on this week's top stories highlighting the intersection of these old guard and new school areas of finance with this recap compiled by The Fly. 1. CRYPTO EXCHANGE HACKED: Japanese cryptocurrency exchange operator Tech Bureau Corp. said roughly $60M worth of bitcoin and other digital currencies were stolen from its platform last Friday when its Zaif cryptocurrency exchange was accessed illegally by hackers over a two-hour period, The Wall Street Journal reported Thursday. Tech Bureau, which found abnormal activity on it servers three days later on September 17 and notified Japanese authorities after uncovering the hack, said about two-thirds of the Y6.7B, or $59.7M, in stolen assets were from customer accounts and the rest belonged to the company. 2. NY AG SAYS CRYPTO EXCHANGES LACK INTEGRITY: On Tuesday, New York Attorney General Barbara Underwood announced the results of the Virtual Markets Integrity Initiative, a fact-finding inquiry into the policies and practices of platforms used by consumers to trade virtual or "crypto" currencies like bitcoin and ether. In a statement, Underwood said, "New Yorkers deserve basic transparency and accountability when they invest - whether on the New York Stock Exchange or on a cryptocurrency platform. Yet, as our report details, many virtual currency platforms lack the necessary policies and procedures to ensure the fairness, integrity, and security of their exchanges. With this report, we hope to give New Yorkers the tools they need to make educated decisions on whether to entrust their money to a cryptocurrency platform and to help protect themselves against theft, fraud, and abuse."3. BITCOIN ETFS DELAYED: The Securities and Exchange Commission is seeking additional feedback on a proposal to list an exchange-traded fund that invests in bitcoin from Van Eck Securities and SolidX Management, Bloomberg reported Thursday. The agency, which already received over 1,400 comment letters on the proposal, is looking for views on market manipulation as well as surveillance and those wishing to comment have 21 days after the SEC's order is published. 4. COINBASE NAMES CHIEF LEGAL OFFICER: Coinbase said in a Wednesday blog post that it has named Brian Brooks as its new chief legal officer. Brooks' arrival is part of the company's effort to expand its legal, compliance and government affairs capabilities as its heads "into this next chapter for the company and the cryptocurrency industry as a whole." Brooks most recently served as EVP, general counsel and corporate secretary of Fannie Mae (FNMA). 5. IDEANOMICS, AMPEN TRADE TECH ENTER JV: Ideanomics (SSC) announced that it has entered into joint venture with APMEN Trade Tech to establish an enterprise focusing on digital supply chain services using blockchain and super artificial intelligence for the Asia-Pacific Model Electronic Port Network APEC's online port clearance system. Ideanomics will have a majority interest of 60% in the joint venture. CRYPTO STOCK PLAYS: Cryptocurrency revenues have been pointed to as reasons to be bullish on Advanced Micro Devices (AMD) and Nvidia (NVDA) in select research. Overstock (OSTK), DPW Holdings (DPW), Kodak (KODK), Ideanomics, Riot Blockchain (RIOT), Pareteum (TEUM) and Social Reality (SRAX) are other stocks that have been touted, or promoted themselves, as a way to play the crypto theme. PRICE ACTION: As of time of writing, bitcoin rose about 4.6% this week to $6,747 in U.S. dollars, according to CoinDesk. WANT BITCOIN NEWS ALERTS?: To receive alerts on stories relating to bitcoin and other cryptocurrencies, Fly subscribers can enter "Bitcoin" into the "Add symbols" box of their portfolios.
REV

Hot Stocks

09:47 EDT Revlon falls -7.2% - Revlon is down -7.2%, or -$1.75 to $22.45.
FIYY

Hot Stocks

09:47 EDT Barclays ETN+ FI Enhanced Global High Yield ETN Series B falls -10.1% - Barclays ETN+ FI Enhanced Global High Yield ETN Series B is down -10.1%, or -$10.60 to $94.00.
VRTV

Hot Stocks

09:47 EDT Veritiv falls -10.9% - Veritiv is down -10.9%, or -$4.85 to $39.85.
AYI

Hot Stocks

09:47 EDT Acuity Brands rises 5.8% - Acuity Brands is up 5.8%, or $9.36 to $170.49.
ADT

Hot Stocks

09:47 EDT ADT Inc. rises 9.4% - ADT Inc. is up 9.4%, or 84c to $9.76.
SCS

Hot Stocks

09:47 EDT Steelcase rises 18.6% - Steelcase is up 18.6%, or $3.00 to $19.15.
RIG

Hot Stocks

09:42 EDT Transocean announces six-well contract for Transocean Norge - Transocean announced that the newbuild, harsh environment semisubmersible Transocean Norge was awarded a six-well contract (estimated 300 days) with Equinor in the Norwegian Continental Shelf. The contract is expected to commence in July 2019, following the shipyard delivery of the rig in early 2019. Transocean will operate the Transocean Norge and has a 33% interest in the joint venture that owns the rig, with the remaining 67% interest owned by Hayfin Capital. The contract backlog is approximately $89M, excluding a bonus opportunity and other services. The contract is denominated approximately 55% in U.S. dollars and 45% in Norwegian kroner. Additionally, the contract includes four one-well options.
TKPYY

Hot Stocks

09:35 EDT Takeda Pharmaceutical receives positive CHMP opinion recommending Alunbrig - Takeda Pharmaceutical announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the full approval of ALUNBRIG as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously treated with crizotinib. ALUNBRIG is a tyrosine kinase inhibitor designed to target and inhibit the ALK mutation in NSCLC. Approximately three to five percent of NSCLC patients globally have the ALK mutation. If the CHMP opinion is affirmed, and the European Commission approves ALUNBRIG, it will become the only ALK inhibitor available in the European Union as a one tablet per day dose that can be taken with or without food. The randomized, global Phase 2 ALTA trial was designed to investigate the efficacy and safety of ALUNBRIG in patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib. Patients were randomized to receive one of two regimens of ALUNBRIG: 90 mg of ALUNBRIG once daily or 180 mg once daily with seven-day lead-in at 90 mg once daily. As part of this submission, the CHMP also reviewed data from the first interim analysis of the Phase 3 ALTA-1L trial, which met its primary endpoint, as supportive evidence. In ALTA-1L, treatment with ALUNBRIG resulted in a statistically and clinically significant improvement in PFS versus crizotinib as assessed by a blinded independent review committee. The safety profile associated with ALUNBRIG was generally consistent with prior studies and approved U.S. and Canadian labeling. The CHMP positive opinion for ALUNBRIG will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 member states of the European Union, as well as Norway, Liechtenstein and Iceland.
MYL AMGN

Hot Stocks

09:34 EDT Mylan, Biocon announce positive CHMP opinion for Fulphila - Mylan and Biocon announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Fulphila, a biosimilar to Amgen's (AMGN) Neulasta. The CHMP positive opinion is based upon a review of evidence demonstrating biosimilarity. Data submitted as part of the Marketing Authorization Application included similarity assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity to the reference product, Neulasta. The Phase I program in healthy volunteers and Phase III clinical study conducted in breast cancer patients receiving adjuvant and neoadjuvant chemotherapy demonstrated no clinically meaningful differences in terms of pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity compared to Neulasta. The CHMP positive opinion will now be considered by the European Commission. The decision on approval is expected by November 2018. Fulphila was approved by the U.S. Food and Drug Administration earlier this year and is the first FDA-approved biosimilar for Neulasta in the U.S. Regulatory applications for Fulphila also have been submitted in Australia, New Zealand, Canada and several other countries.
CHDN

Hot Stocks

09:31 EDT Churchill Downs to construct rooftop lounge at Kentucky Derby - Churchill Downs will create an experience for guests of the 2019 Kentucky Derby and beyond. The Louisville, Kentucky racetrack has announced plans for a $5M capital investment that will expand the Starting Gate Suites through the construction of a new 20,000-square-foot rooftop garden which will deliver a unique hospitality experience with exclusive sightlines and access for more than 500 ticketed guests. The rooftop space, located atop the Starting Gate Suites on the north end of the 190-acre facility, will provide covered reserved seating for more than 250 guests and approximately 250 additional standing room only access tickets. More information on the individual tickets to the new space for the 2019 Kentucky Derby will be made available during the online ticket sale later this year. Guests on the rooftop will be able to gaze at a panoramic view of Louisville while enjoying access to several bars and various food offerings. There also will be a tiered balcony for viewing of Churchill Downs' races, including a prime observation that overlooks the start of the Kentucky Derby at the top of the famed homestretch.
AVP

Hot Stocks

09:30 EDT Avon Products targets $400M in cost savings by 2021 - At its 2018 Investor Day, Avon Products provided certain financial initiatives and investment targets by 2021, driven by the execution of its new strategy to Open Up Avon and return to growth. As outlined in the presentation, Avon's priorities include rebooting the Company's direct selling proposition, modernizing the brand, unlocking digital and e-commerce capabilities and driving a performance-led culture. Cost savings: by 2021, totaling a targeted $400M generated from four primary sources: Manufacturing & Sourcing: Manufacturing footprint optimization, outsourcing and targeted sourcing efficiencies; Distribution and General & Administrative: Rationalization of the distribution footprint, outsourcing and targeted general and administrative efficiencies; Back Office: Zero based redesign of back office functions, reduction of certain facilities, real estate and other discretionary spend optimization; and Revenue management, interest and tax. Investments in Commercial initiatives and Digital & IT infrastructure: potentially totaling approximately $300M, allocated as follows: Commercial initiatives: Reinvest in Representative training and recognition; Avon brand modernization initiatives; Restore competitiveness within Core categories; and New categories and markets. Digital & IT infrastructure initiatives, including: Modernized systems environment; Digital talent; and Digital tools and analytics. Continued focus on strengthening the balance sheet: Following the cost savings initiatives, the Company's cash generation should exceed its investment plans. Accordingly, Avon does not anticipate increasing its debt position and will remain focused on reducing debt. "We believe that our strategy to Open Up Avon will enable the Company to stabilize our financial results and achieve our goals of low-single digit revenue growth and low double-digit margins by 2021, delivering on our commitment to shareholders," said Jan Zijderveld, Avon CEO. "We believe that being 'Fit for Purpose' across our manufacturing, distribution and back office structures can yield substantial savings that can be prudently reallocated to fuel innovation, important infrastructure improvements and ultimately grow our business."
MSI

Hot Stocks

09:27 EDT Motorola Solutions, UK Home Office reach agreement to implement ESN approach - Motorola Solutions and the UK Home Office have reached an agreement on terms for the new direction of the UK Emergency Services Network as well as an agreement on terms to extend the Airwave nationwide digital radio network. The ESN agreement supports the phased deployment of the ESN program, ensuring that public safety organizations will benefit from the new network's capabilities as soon as possible. Public safety organizations across the United Kingdom will be able to roll out the capabilities of ESN at their desired pace while maintaining the Airwave network service to ensure uninterrupted service. As part of its delivery of ESN User Services, Motorola Solutions will implement a 3GPP standards-based push-to-talk software solution. This global platform uses technology from Kodiak Networks, which was acquired by Motorola Solutions in 2017. To allow for the new phased deployment strategy, the Motorola Solutions ESN agreement will be extended by 30 months through the end of 2024. The Airwave agreement, which is expected to be completed later in the year, will extend the network on substantially similar terms for three additional years to Dec. 31, 2022, with the option to be further extended. The company will also upgrade this critical public safety network to ensure the requirements of public safety users continue to be met.
ENTX MRK

Hot Stocks

09:21 EDT Entera Bio appoints Arthur Santora as CMO - Entera Bio announced the appointment of Arthur Santora II as its new CMO, effective immediately. Santora has more than 30 years of experience in the biotech industry. He has spent the majority of his career in the clinical research team at Merck (MRK), where he was the lead clinical research physician responsible for much of the clinical development of Fosamax. Santora was closely involved in the clinical development of Merck's once-weekly Fosamax Plus D, the first drug/vitamin combination tablet in the U.S. His position when he retired from Merck in 2017 was as scientific associate VP of clinical research, where he was directly responsible for the technical and scientific support for all clinical research of Fosamax/Fosamax plus D and contributed to the development of many other osteoporosis and endocrine marketed and investigational drugs.
EAST WMT

Hot Stocks

09:05 EDT Walmart authorizes sale of Redneck Riviera Whiskey in Indiana stores - Eastside Distilling (EAST) announced an authorization from Walmart (WMT) to add Redneck Riviera Whiskey to Walmart's line-up of fine spirits in the state of Indiana. The Redneck Riviera Whiskey brand is a joint collaboration between Eastside and John Rich, the multi-platinum country-music artist and one-half of the award-winning duo Big & Rich.
AIG

Hot Stocks

09:04 EDT AIG to acquire Glatfelter Insurance Group, terms not disclosed - American International Group announced it has entered into a definitive agreement to acquire Glatfelter Insurance Group, a full-service broker and insurance company providing services for specialty programs and retail operations. Headquartered in York, Pennsylvania, Glatfelter brings high-quality program underwriting capabilities that will accelerate the strategic positioning of AIG's General Insurance business. The terms of the transaction were not disclosed. The transaction is expected to close in the fourth quarter of 2018.
MU...

Hot Stocks

09:03 EDT Fly Intel: Pre-market Movers - HIGHER: Mazor Robotics (MZOR), up 10% after announcing Medtronic (MDT) will acquire all outstanding ordinary shares of Mazor for $58.50 per American Depository Share... Texas Instruments (TXN), up 2% after raising its dividend 24% and announcing a $12B share repurchase plan... AT&T (T), up 1.5% after revising its operating segments after the acquisition of Time Warner and seeing its upgraded to Buy from Neutral at UBS. UP AFTER EARNINGS: Steelcase (SCS), up 15%. DOWN AFTER EARNINGS: Micron (MU), down 3%... United Natural Foods (UNFI), down 11%. LOWER: GTx (GTXI), down 90% after the company announced that the Phase 2 ASTRID Trial of orally-administered enobosarm in post-menopausal women with stress urinary incontinence did not achieve statistical significance on the primary endpoint... Western Asset Mortgage (WMC), down 5% after its 6.5M share spot secondary offering priced at $10.85 per share.
CTT

Hot Stocks

09:01 EDT CatchMark Timber declines to make firm offer to acquire Phaunos Timber Fund - CatchMark Timber announced the company has determined not to make an offer to acquire Phaunos Timber Fund Limited, a Channel Islands domiciled, closed-end real estate fund. Earlier this month, CatchMark announced a potential offer for Phaunos, which valued Phaunos at 57c per share to be paid in new shares of CatchMark Class A common stock.
MYL ACOR

Hot Stocks

08:59 EDT Mylan announces U.S. launch of generic Ampyra tablets - Mylan (MYL) announced the U.S. launch of Dalfampridine Extended-Release Tablets, 10 mg, the authorized generic version of Acorda's (ACOR) Ampyra, which is indicated to improve walking in adult patients with multiple sclerosis. The launch comes after the United States Court of Appeals for the Federal Circuit upheld the United States District Court for the District of Delaware's decision to invalidate four Ampyra patents: U.S. Patent Nos. 8,663,685, 8,007,826, 8,440,703, and 8,354,437. Acorda's U.S. Patent No. 5,540,938, previously upheld by the District Court, expired on July 30, 2018.
VRSK GWRE

Hot Stocks

08:59 EDT Verisk, Guidewire announce increased adoption of ISO Electronic Rating Content - Verisk (VRSK) and Guidewire Software (GWRE) announced the increased adoption of Guidewire Product Content Management based on Verisk's ISO Electronic Rating Content in the insurance market. Managing ISO rating content with Product Content Management makes it easier for insurers to stay current with the latest commercial lines rules and advisory loss costs because the rating content is received electronically and updated automatically. More than 30 Guidewire PolicyCenter customers have elected to use Product Content Management based on ISO ERC to update their rating content for commercial lines. Guidewire is currently offering access to ISO programs via ISO ERC for businessowners, commercial auto, commercial property, crime, general liability, and workers' compensation.
TBK

Hot Stocks

08:49 EDT Triumph Bancorp sees Q3 EPS to be hurt by charge related to 'fraudulent conduct' - In a regulatory filing last night, Triumph Bancorp disclosed that the company expects its third quarter 2018 net income and EPS to be adversely affected by a charge arising from a single asset-based lending relationship at its banking subsidiary, TBK Bank, SSB. The charge resulted from fraudulent conduct believed to be perpetrated by one or more employees of the borrower. The primary cause of the charge is the borrower's submission of false borrowing base certificates and supporting documentation that resulted in advances in excess of available collateral. A notice of default has been issued to the borrower and the facility is in the process of liquidation. The company currently estimates that it will charge off approximately $4.0M as a result of this loan relationship in its financial statements for the quarter ended September 30, 2018. Approximately $0.7M of the charge off had specific reserves previously recorded. In addition, the company expects that the charge-off will result in an increase in the estimate of its allowance for loan loss reserves recorded against the remaining asset-based lending portfolio in an amount up to approximately $2.7M as a result of higher loss factors being incorporated into the company's allowance for loan loss reserve methodology for the three months ended September 30, 2018. The company estimates that its third quarter after-tax earnings per share will be reduced by an amount up to approximately 17c per diluted share as a result of the aggregate impact of these items. The company is working to preserve and recover assets in connection with the liquidation of the borrower. The remaining balance of the loan after the charge off is $3.2M. "Based on the company's review of the circumstances of the fraudulent activities involving this borrower and a review conducted of the remainder of its asset-based lending portfolio, the company believes this incident is an isolated occurrence and not indicative of deterioration of credit in its overall loan portfolio or an increase in exposure to fraud related losses in its asset-based lending business," Triumph Bancorp stated.
DUK

Hot Stocks

08:36 EDT Duke Energy reaches agreement with consumer groups on Edwardsport costs - If approved by state utility regulators, Duke Energy Indiana customers will pay $30M less for costs at the company's Edwardsport coal gasification power plant due to an agreement with some of the state's consumer groups. The proposal, which was filed with state regulators today, is subject to Indiana Utility Regulatory Commission approval. Participants in the agreement are the Indiana Office of Utility Consumer Counselor, the Indiana Industrial Group representing Duke Energy's Indiana customers, and Nucor Steel-Indiana. The agreement will remain in effect until new rates are established in the company's next base rate case, which is expected to be filed in mid-2019 with rates effective in mid-2020. It addresses the pending Edwardsport filing at the commission and eliminates the need for future filings until the overall rate case. Because of the agreement's provisions, Duke Energy expects to take a pretax charge of approximately $32M in the third quarter of 2018. Key provisions of the proposed settlement include: The company has agreed not to bill customers $30M of operating costs deferred since the plant's in-service date. Customer bills will decrease approximately 0.5% and will not be adjusted for Edwardsport plant costs until the time of a decision in the company's next base rate case. The agreement also designates $1.7M out of shareholder funds for low-income energy assistance and renewable energy development.
YTEN

Hot Stocks

08:35 EDT Yield10 Bioscience grants research license to Forage Genetics for sorghum - Yield10 Bioscience announced that it has granted a non-exclusive research license to Forage Genetics International, a subsidiary of Land O'Lakes, to evaluate five novel yield traits in forage sorghum. Under the license, Forage Genetics plans to conduct research with the novel traits within its sorghum development program as a strategy to improve biomass yields. The novel yield traits included in the research license agreement include C3003, a trait derived from algae, as well as four traits from Yield10's GRAIN platform, C4001, C4002, C4003 and C4029. The C4000 series traits included in the research license have been shown to significantly increase photosynthesis and biomass in research conducted by Yield10. One of the traits, C4029, may increase yield as well as confer drought tolerance to crops. The key objective of the licensing agreement is to provide Forage Genetics with novel traits to test alone and/or in any combination in sorghum that may identify new yield traits for potential future licensing from Yield10 for development and commercial deployment. Yield10 has established an open innovation model for the evaluation of its novel yield traits by agricultural companies. The intended benefit of the model is to allow agricultural companies to deploy traits in their proprietary, elite germplasm and test the performance of these traits in greenhouse and field studies they design and control. The research licenses granted under this model are non-exclusive but allow the licensees to initiate negotiations for exclusive licenses for traits they may seek to license from Yield10. Yield10's innovation platform and pipeline of yield traits are applicable to commercial row crops in North America, and therefore may represent significant opportunity for commercialization of Yield10 discovered traits through licensing agreements.
DUK

Hot Stocks

08:34 EDT Duke Energy reaches agreement with consumer groups on Edwardsport costs - If approved by state utility regulators, Duke Energy Indiana customers will pay $30M less for costs at the company's Edwardsport coal gasification power plant due to an agreement with some of the state's consumer groups. The proposal, which was filed with state regulators today, is subject to Indiana Utility Regulatory Commission approval. Participants in the agreement are the Indiana Office of Utility Consumer Counselor, the Indiana Industrial Group representing Duke Energy's Indiana customers, and Nucor Steel-Indiana. The agreement will remain in effect until new rates are established in the company's next base rate case, which is expected to be filed in mid-2019 with rates effective in mid-2020. It addresses the pending Edwardsport filing at the commission and eliminates the need for future filings until the overall rate case.
ESQ

Hot Stocks

08:32 EDT Esquire Financial announces pre-tax, one-time charge of approximately $1.2M - Esquire Financial announced that the company expects to incur a pre-tax one-time charge of approximately $1.2M, related to the passing of the company's former Executive Chairman, Dennis Shields, on August 10, 2018. The charge is comprised of $673,000 in accelerated vesting of Shields' stock and option grants due to his passing and a $500,000 payment related to Shields' employment as Executive Chairman. The $1.2M charge (pre-tax), or approximately 11c per diluted common share, will be incurred by the company in the third quarter of 2018.
SGBX

Hot Stocks

08:31 EDT SG Blocks establishes alliance with Sequential Modular Partners Business Wire - SG Blocks announced it has established a strategic partnership with Sequential Modular Partners. The new minority-owned and managed company will deliver integrated modular solutions to Fortune 500 companies, local, state and federal agencies and the U.S. military. SG Blocks will be the exclusive product supplier to Sequential, which will be based in Dallas, Texas. The majority partners of the joint venture are Wayne Lawrence, Tim Brown and Pinnacle Design Group. SG Blocks will have a minority interest in the company. Lawrence is CEO of Sequential Modular Partners and has over 30 years of experience in the modular construction sector. He has built an enviable track record of customer relationships during his career. Brown, NFL Hall of Famer and Heisman Trophy winner, has agreed to join the Sequential team and will work closely with Wayne in establishing quality client relationships all over the country. Pinnacle Design Group, located in Norman, Oklahoma, has over 25 years of specialized multi-disciplined design/build experience in government contracting, multi-family, hospitality, commercial and sustainable projects.
GTXI

Hot Stocks

08:30 EDT GTx trading resumes
BNGO

Hot Stocks

08:15 EDT Bionano Genomics announces separate trading of common stock, warrants - Bionano Genomics announced that the units sold in the company's initial public offering have separated in accordance with their terms. Each unit consisted of one share of common stock and one warrant to purchase one share of common stock. At the commencement of trading, the shares of common stock and the warrants will trade separately on the Nasdaq Capital Market under the symbols (BNGO) and (BNGOW), respectively. The units, which traded under the symbol (BNGOU) will no longer be listed.
BSGM

Hot Stocks

08:12 EDT BioSig Technologies begins trading on Nasdaq - BioSig Technologies announced that shares of its common stock have begun officially trading on the Nasdaq Capital Market, under the ticker (BSGM). BioSig's listing on the Nasdaq is the company's most recent operational achievement. In August, the company received 510 clearance from the FDA for their patented advanced signal acquisition and processing technology, PURE EP System. The non-invasive technology is a computerized system intended to enhance electrocardiographic and intracardiac signals for patients undergoing electrophysiology, or EP, procedures in an EP laboratory for the treatments of arrhythmia, or irregular heartbeat. The company completed 13 pre-clinical studies at Mayo Clinic and Mount Sinai to date and received first units from its contract manufacturer, Minnetronix, in September 2018. BioSig recently made an announcement about their ongoing progress with effective physician engagement and continues to add experienced industry hires to its clinical and commercial teams.
BKYI

Hot Stocks

08:09 EDT BIO-key appoints Frederick Corsentino as CRO - BIO-key announced the appointment of Frederick Corsentino as CRO, a new position at the company. Corsentino will be responsible for refining and focusing BIO-key's business development, sales and integrated marketing functions in order to optimize revenue growth from its base of biometric software and hardware solutions. He has decades of sales leadership experience and a track record of revenue growth accomplishment, with a particular emphasis on emerging technologies including security. Corsentino launched a consulting practice that advises security and information research and technology companies on go-to market strategies to increase sales prospects and drive revenue growth. He also recently served as CRO at Comodo, a cyber security provider, where he managed the sales team and successfully launched a new line of end point protection and cloud computing security products. From 2005 to 2007 he led sales at Meru Networks, growing worldwide revenues from $1M to $40M in two years.
ETFC

Hot Stocks

08:06 EDT E-Trade appoints CFO Michael Pizzi to COO - E-Trade Financial announced that CFO Michael Pizzi will expand his role to become COO, assuming oversight of operations while continuing his current responsibilities as CFO.
WHLR

Hot Stocks

08:05 EDT Wheeler REIT receives ISS backing for proxy card - Wheeler REIT announced that ISS has issued its recommendation for shareholders to vote with the company on its white proxy card in favor of: the reelection of seven of its eight members of the board, advisory vote on the frequency of executive compensation advisory votes for one year and the ratification of Cherry Bekaert as the company's independent registered public accounting firm for the fiscal year ending, December 31. ISS has also recommended to not vote for the Stilwell Group's nominees on the green proxy card.
GTXI

Hot Stocks

08:05 EDT GTx annnounces placebo-controlled ASTRID trial did not meet primary endpoint - GTx announced that the ASTRID Trial, a Phase 2 double-blind, placebo-controlled clinical trial of orally-administered enobosarm in post-menopausal women with stress urinary incontinence, did not achieve statistical significance on the primary endpoint of the proportion of patients with a greater than 50% reduction in incontinence episodes per day compared to placebo. The percentage of patients with a greater than 50% reduction after 12 weeks of enobosarm treatment was 58.9% for 3mg, 57.7% for 1mg and 52.7% for placebo. Enobosarm was generally safe and well tolerated. Reported adverse events were minimal and similar across all treatment groups. "We are very disappointed that the ASTRID Trial did not achieve its primary endpoint," said Robert Wills, executive chairman of GTx. "We plan to conduct a full review of all the data. We want to thank the patients, physicians, study coordinators and the entire GTx team for their support of this novel study. We have an ongoing preclinical program assessing the potential of SARDs, our novel selective androgen receptor degrader technology, to treat castration-resistant prostate cancer. We are currently on target to have development candidates by year end, which we potentially plan to take into IND-enabling studies."
NXTD

Hot Stocks

08:02 EDT Nxt-ID announces plans to spin-off payments division into independent company - Nxt-ID announced that it intends to separate its payments, authentication and credential management business into an independent company and distribute shares of the newly created company to its shareholders through the execution of a spin-off, which the company believes will qualify as a tax free distribution. Immediately following the transaction, which is expected to be completed by November 15, 2018, Nxt-ID shareholders who own common shares of Nxt-ID on the dividend date of October 15, 2018 will own shares of both companies. The new company will include the assets acquired in the May 2017 business combination with Fit Pay, Inc. as well as the payment, authentication and credential management assets that the company developed previously. Following the spin-off, the new company has an investment commitment for $6M to fund its operations. The new company will apply for listing on NASDAQ. Michael Orlando, current Nxt-ID COO and President of Fit Pay, will be the CEO of the new company. Orlando and Pereira will serve on the Boards of both companies.
GTXI

Hot Stocks

07:55 EDT GTx trading halted, news pending
LLY

Hot Stocks

07:48 EDT Eli Lilly receives positive CHMP opinion for Emgality - Eli Lilly announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for Emgality for the prophylaxis of migraine in adults who have at least four migraine days per month. In June 2018, Lilly announced the intended brand name, Emgality, was conditionally accepted by the U.S. FDA.
MLNT

Hot Stocks

07:40 EDT Melinta Therapeutics announces CHMP approval recommendation for Vabomere - Melinta Therapeutics announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has adopted a positive opinion recommending Vabomere for approval as a treatment for adult patients with complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia including ventilator associated pneumonia, bacteraemia that occurs in association with any of these infections, and infections due to aerobic Gram-negative organisms where treatment options are limited. The CHMP's opinion will be reviewed by the European Commission, or EC, which is expected to make a final decision regarding marketing authorization within 67 days of receiving the CHMP opinion. If approved by the EC, marketing authorization for Vabomere will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein. Milestone payment obligations related to Vabomere's European approval would not take effect until marketing authorization is granted by the EC.
PRIM

Hot Stocks

07:37 EDT Primoris provides update on Atlantic Coast Pipeline Project - Primoris provided an update to the work being done by Rockford, part of the Pipeline and Underground segment, on the Atlantic Coast Pipeline project. With the decision by the Federal Energy Regulatory Commission, or FERC, to allow construction activities to resume on ACP, Rockford has resumed work on the project doing various activities in West Virginia and North Carolina. Winter weather is expected to curtail some activities in West Virginia later this year, but at this time, the company anticipates that weather permitting, work in North Carolina will continue through the winter months. Primoris estimates that during the five weeks impacted by the FERC stop work order, revenue on ACP was roughly $35M less than originally planned. It remains to be seen how much of the work can be accelerated during Q4.
NVS

Hot Stocks

07:34 EDT Novartis announces CHMP approval recommendation for pegfilgrastim - Sandoz, a Novartis division, announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has adopted a positive opinion for marketing authorization of its proposed biosimilar pegfilgrastim, a long-acting version of supportive oncology care medicine filgrastim. Sandoz is committed to increasing patient access to high-quality biosimilars, with five marketed and seven approved biosimilars in Europe. Pegfilgrastim is a long-acting form of filgrastim, a biosimilar medicine that stimulates the production of white blood cells and stem cells. Sandoz is seeking approval for use of biosimilar pegfilgrastim in the same indication as the reference medicine, for the prevention of chemotherapy-induced infection, known as febrile neutropenia, which includes fever brought on by low neutrophils. The comprehensive data package, submitted as part of the marketing authorization application, includes analytical, preclinical, and clinical data, which demonstrate that Sandoz biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality. The European Commission, or EC, takes binding decisions on the authorization of medicines valid throughout the EU. It bases its decisions on scientific assessments by the CHMP, ensuring that medicines comply with high quality, safety and efficacy standards. If approved by the EC, the centralized marketing authorization will be valid in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area, will take corresponding decisions based on the EC's recommendation.
INVA GSK

Hot Stocks

07:32 EDT Innoviva, GSK receive positive CHMP opinion for Trelegy Ellipta - GlaxoSmithKline (GSK) and Innoviva (INVA) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, has issued a positive opinion today supporting the use of Trelegy Ellipta in a broader group of patients with moderate to severe chronic obstructive pulmonary disease, or COPD, and that labelling, if approved, will be updated to further reflect its effect on exacerbations of COPD. The expanded indication for the once-daily single inhaler triple therapy would enable use by patients not adequately treated by a long-acting muscarinic receptor antagonist and long-acting beta2-agonist. It would also reference the effect on exacerbations based on data from the InforMing the PAthway of COPD Treatment study.
NE

Hot Stocks

07:31 EDT Noble Corp. buys new Gusto MSC CJ46 design jackup rig from PaxOcean - Noble announced the purchase of a new Gusto MSC CJ46 design jackup rig from the PaxOcean Group in connection with a concurrently awarded drilling contract. Noble paid $33.75M of the $93.75M purchase price in cash, with the remainder of the purchase price, or $60M seller-financed at a 4.25% interest rate paid in cash and 1.25% paid in kind over the term of the financing. The Company used existing cash balances for the initial payment and the secured seller-financed amount is to be repaid in four years. The Company also has an option for the purchase of a second newbuild CJ46 jackup from PaxOcean. The newbuild jackup, to be named the Noble Johnny Whitstine, was built at the PaxOcean Graha shipyard in Batam, Indonesia. The robust rig design for moderate environments allows for operations in water depths of up to 375 feet and well depths of 30,000 feet. A modern drilling control system and versatile 70 ft. x 40 ft. envelope cantilever skidding system equipped with two blow out preventers contribute to the rig's enhanced drilling capabilities. In connection with the purchase, Noble has entered into a new drilling contract in the Middle East region with a three-year primary term, plus a one-year option, with an expected commencement of early-2019.
ABBV RHHBY

Hot Stocks

07:30 EDT AbbVie gets positive CHMP opinion for VENCLYXTO in combination with rituximab - AbbVie announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for VENCLYXTO in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia who have received at least one prior therapy. The positive CHMP opinion is a scientific recommendation for marketing authorization to the European Commission, which will deliver its final decision, valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
NVS

Hot Stocks

07:30 EDT Sandoz receives positive CHMP opinion for proposed biosimilar pegfilgrastim - Sandoz, a Novartis, announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for marketing authorization of its proposed biosimilar pegfilgrastim, a long-acting version of supportive oncology care medicine filgrastim. Sandoz is committed to increasing patient access to high-quality biosimilars, with five marketed and seven approved biosimilars in Europe. Pegfilgrastim is a long-acting form of filgrastim, a biosimilar medicine that stimulates the production of white blood cells and stem cells. Sandoz is seeking approval for use of biosimilar pegfilgrastim in the same indication as the reference medicine, for the prevention of chemotherapy-induced infection, known as febrile neutropenia, which includes fever brought on by low neutrophils. The comprehensive data package, submitted as part of the Marketing Authorization Application, includes analytical, preclinical, and clinical data, which demonstrate that Sandoz biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality. Febrile neutropenia is a serious and possibly life-threatening condition that can develop in people with cancer who receive chemotherapy. Despite treatment advances, febrile neutropenia may pose risks to a person's chemotherapy treatment plan, with consequences such as dose reductions, discontinuation of treatment or changing to a less effective regimen. The European Commission takes binding decisions on the authorization of medicines valid throughout the EU. It bases its decisions on scientific assessments by the CHMP, ensuring that medicines comply with high quality, safety and efficacy standards. If approved by the EC, the centralized marketing authorization will be valid in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area, will take corresponding decisions based on the EC's recommendation.
NVS

Hot Stocks

07:30 EDT Novartis announces CHMP approval recommendation for Gilenya - Novartis announced the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended approval of Gilenya for the treatment of children and adolescents 10 to 17 years of age with relapsing remitting forms of multiple sclerosis, or RRMS. If approved, Gilenya is expected to be the first oral disease-modifying therapy indicated for these patients based on a randomized controlled clinical study. The younger patient population experiences two-to-three times as many relapses as adults, often leading to a more severe prognosis and earlier disability compared to adult-onset MS. This market authorization would expand the age range of Gilenya, one of the most prescribed MS treatments worldwide. Gilenya was previously approved for adults with RRMS aged 18 years and older in Europe. The European Commission will review the CHMP opinion and is expected to deliver its final decision within three months. The decision will be applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein. Gilenya received FDA approval for the treatment of children and adolescents 10 years of age and older with MS in May.
NVS

Hot Stocks

07:29 EDT Novartis receives positive CHMP opinion for Gilenya - Novartis announced the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended approval of Gilenya for the treatment of children and adolescents 10 to 17 years of age with relapsing remitting forms of multiple sclerosis, or RRMS. If approved, Gilenya is expected to be the first oral disease-modifying therapy indicated for these patients based on a randomized controlled clinical study. The younger patient population experiences two-to-three times as many relapses as adults, often leading to a more severe prognosis and earlier disability compared to adult-onset MS. If approved, Gilenya would address the urgent need faced by these young people. This market authorization would expand the age range of Gilenya, one of the most prescribed MS treatments worldwide. Gilenya was previously approved for adults with RRMS aged 18 years and older in Europe.
OASM

Hot Stocks

07:26 EDT Oasmia announces CHMP approval recommendation for Apealea - Oasmia announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has adopted a positive opinion recommending approval of Apealea in combination with carboplatin for treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. The CHMP considers that the product Apealea in combination with carboplatin has a positive benefit-risk balance and is considered approvable for the above-mentioned indication. The CHMP's positive opinion will now be considered by the European Commission. If the CHMP opinion is affirmed, the European Commission will grant a centralized marketing authorization with unified labelling that is valid in 28 countries of the European Union, as well as the European Economic Area members, Iceland, Lichtenstein and Norway. The CHMP recommendation is based on clinical trials including the pivotal study OAS 07OVA. This study showed that the risks of disease progression or death after Apealea treatment in combination with carboplatin are similar as after Cremophor EL-formulated paclitaxel in combination with carboplatin.
ONCE NVS

Hot Stocks

07:24 EDT Spark Therapeutics announces CHMP approval recommendation for Luxturna - Spark Therapeutics (ONCE) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, adopted a positive opinion recommending approval of Luxturna, a one-time gene therapy for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. The positive CHMP opinion is based on data from a Phase 1 clinical trial, its follow-up trial and a Phase 3 trial that together enrolled 43 participants with inherited retinal disease caused by mutations on both copies of the RPE65 gene. The Phase 3 trial was the first randomized, controlled Phase 3 gene therapy trial for a genetic disease. Spark Therapeutics has received orphan product designation for Luxturna from EMA for the treatment of inherited retinal dystrophies. A marketing authorization decision from the European Commission is anticipated approximately within two months. If approved, the authorization will be valid in all 28-member states of the European Union, as well as Iceland, Liechtenstein and Norway. In January, Spark Therapeutics entered into a licensing and supply agreement with Novartis (NVS) to commercialize Luxturna when and if approved in Europe and all markets outside the U.S.
RESN

Hot Stocks

07:11 EDT Resonant CFO Michael Seifert resigns, appoints Jeff Killan interim CFO - Resonant announced its CFO, Michael Seifert, has resigned and will be replaced by Resonant's former CFO and current company consultant, Jeff Killian. Killian has been appointed as the company's interim CFO. Resonant has initiated a search for Seifert's successor and Killian will serve until a successor is in place.
T

Hot Stocks

07:11 EDT AT&T revises operating segments after acquisition of Time Warner - In a regulatory filing, AT&T disclosed that due to organizational changes and its June 14, 2018 acquisition of Time Warner Inc., effective for the quarter ended September 30, 2018, the company is revising its operating segments to align with the new management structure and organizational responsibilities. The new reportable segments are: The Communications segment, which provides wireless and wireline telecom, video and broadband services to consumers located in the U.S. or in U.S. territories and businesses globally; The WarnerMedia segment, which develops, produces and distributes feature films, television, gaming and other content in various physical and digital formats globally. Historical results from AT&T's Regional Sports Network and equity investments, predominately Game Show Network and Otter Media Holdings, previously included in Entertainment Group, have been recast into the WarnerMedia segment and are combined with the Time Warner operations for the period subsequent to the acquisition; The Latin America segment, which provides entertainment and wireless services outside of the U.S.; and The Advertising & Analytics segment, which provides advertising services. AT&T is making available the recasting of the historical reported segment and supplemental results, which will be included in its third-quarter 2018 earnings materials, for the quarters and year ended 2017 and for the quarters ended March 31, and June 30, 2018.
XOMA...

Hot Stocks

07:09 EDT Xoma acquires partial interest position in seven antibodies from Agenus for $15M - Xoma (XOMA) announced that for $15M, it has acquired from Agenus (AGEN) a partial interest position in the rights to potential milestone and royalty payments associated with seven immuno-oncology antibodies currently being developed by Merck (MRK) and Incyte (INCY) under their collaborations with Agenus. The seven royalty interest antibodies are: one Phase 1 antibody being developed by Merck on an undisclosed novel target, Incyte's INCAGN1876 in Phase 1/2 studies, Incyte's INCAGN1949 in Phase 1/2 studies, Incyte's INCAGN2385 in Phase 1 studies, Incyte's INCAGN02390 expected to enter the clinic in 2018 and two preclinical antibodies being developed by Incyte on undisclosed targets. Under the terms of the agreement, XOMA will receive low- to mid-single-digit royalties on future sales of these seven immuno-oncology assets. Additionally, XOMA is entitled to a portion of milestone payments associated with the assets. XOMA has drawn $7.5M from its line of credit to partially fund this transaction.
AGEN...

Hot Stocks

07:08 EDT Agenus closes $15M partial royalty monetization with Xoma - Agenus (AGEN) announced the closing of its non-dilutive royalty transaction with Xoma (XOMA), where Xoma purchased a minority interest in the royalties and milestones that Agenus is eligible to receive from Incyte (INCY) and Merck (MRK). Agenus received $15M at closing and retains the majority (67%) of all future royalties and 90% of all milestones from Incyte and Merck. Agenus also remains eligible to receive up to an additional $450M and $85.5M in potential development, regulatory and commercial milestones from Incyte and Merck, respectively.
ELLO

Hot Stocks

07:07 EDT Ellomay Capital announces approval of Talasol project for financing under EFSI - Ellomay Capital announced that the project for construction of a photovoltaic plant with a peak capacity of 300 MW in the municipality of Talavan, Caceres, Spain, promoted by Talasol Solar, which the Company indirectly wholly owns was approved for financing under the European Fund for Strategic Investments. EFSI is an initiative launched jointly by the European Investment Bank, the European Investment Fund and the European Commission. EFSI is a EUR26B guarantee from the EU budget, complemented by a EUR7.5B allocation of the EIB's own capital. The total amount of EUR33.5B aims to unlock additional investment of at least EUR500B by 2020. EFSI is implemented by the EIB Group and projects supported by it are subject to usual EIB procedures.
SD

Hot Stocks

06:57 EDT SandRidge Energy says interim CEO Griffin not candidate for permanent role - On September 17, William M. Griffin, Jr., Interim President and CEO of SandRidge Energy informed the board of directors that he would not be a candidate to serve as the company's permanent President and CEO. The parties intend for Mr. Griffin to continue serving as Interim President and Chief Executive Officer until a successor is appointed and to continue as a non-employee member of the Board thereafter. The Board has formed a four-member search committee to evaluate and recommend to the Board candidates to serve as permanent President and CEO and lead the execution of the company's full development and growth plan announced at the recent conclusion of the strategic review process. The CEO Search Committee consists of the Chairman of each of the Board's standing committees, Robert G. Alexander, John J. "Jack" Lipinski and Randolph C. Read, together with Jonathan Frates, the Board's Chairman
BEDU

Hot Stocks

06:53 EDT Bright Scholar to acquire 75% interest in Chengdu Yinzhe Education for RMB202.5M - Bright Scholar announced that it entered into an agreement to acquire 75% equity interests in Chengdu Yinzhe Education for a total consideration of RMB202.5M which will be paid in four installments subject to the satisfaction of various closing condition and earn-out arrangements. Subject to the future financial performance of Yinzhe and other conditions under the acquisition agreement, the company may acquire up to an additional 15% equity interests in Yinzhe from year 2021 to 2023. Established in 2015, Yinzhe primarily engages in online career and education mentoring services to overseas Chinese students under brand DreambigCareer. During the past four years, Yinzhe successfully helped overseas Chinese students obtain over 4,000 offers, including interview, internship and full-time job offering in many countries and regions, including the United States, Canada, the United Kingdom, Australia, Europe, Mainland China and Hong Kong till the end of May. In 2017, Yinzhe's total revenue and net profit was RMB54.1M and RMB12M, respectively; in the first half of 2018, Yinzhe's total revenue and net profit was RMB30M and RMB6.8M, respectively.
EGC

Hot Stocks

06:51 EDT Energy XXI Gulf Coast provides update on merger with affiliates of Cox Oil - Energy XXI Gulf Coast provided a statement regarding the closing of the merger with affiliates of Cox Oil. As EGC previously announced on September 10, 2018, on September 9, 2018, EGC and Cox entered into an Amendment No. 1 to the Agreement and Plan of Merger to provide for the closing date of the merger to occur on October 10, 2018. The amendment also provided that Cox cannot refuse to consummate the merger because of any material adverse events occurring on or after the date of the amendment until the closing date. In addition, as previously announced, at EGC's September 6, 2018 special meeting of stockholders, EGC received the two-thirds stockholder approval required for EGC's stockholders to approve the merger. None of the voting results from the EGC special meeting will adversely affect the closing of the merger. In anticipation of the September 10, 2018 scheduled closing date, the FTSE Russell 2000 Index began the process to remove EGC's common stock from the index. On September 19, 2018, FTSE Russell informed EGC that, under FTSE Russell's procedures, FTSE Russell was unable to reverse this action, even though the merger closing date had been extended. EGC and Cox continue to work toward closing the merger on October 10, 2018.
TMST

Hot Stocks

06:41 EDT TimkenSteel appoints Kristopher Westbrooks as new CFO - TimkenSteel (TMST) has named Kristopher Westbrooks as executive vice president and CFO to succeed current CFO Christopher Holding, who is leaving the company, effective September 23. Westbrooks will join the company in this new role on September 24. Westbrooks was most recently with A. Schulman, where he served as vice president, Chief Accounting Officer and corporate controller responsible for leading the integration of A. Schulman's recently completed merger with LyondellBasell (LYB).
SRPT

Hot Stocks

06:32 EDT Sarepta receives negative CHMP re-examination opinion for Eteplirsen - Sarepta Therapeutics announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency, has confirmed its 31 May 2018 negative opinion for a Conditional Marketing Application for eteplirsen. Eteplirsen is designed to treat approximately 13% of the Duchenne muscular dystrophy community who have genetic mutations amenable to exon 51 skipping. The company expects the European Commission to adopt the CHMP opinion by year-end 2018.
BTU

Hot Stocks

06:08 EDT Peabody Energy to purchase Shoal Creek coal mine from Drummond for $400M - Peabody Energy announced that it has signed a definitive agreement to purchase the Shoal Creek metallurgical coal mine from private coal producer Drummond for $400M. Shoal Creek is located on the Black Warrior River in central Alabama and serves Asian and European steel mills with high-vol A coking coal. The transaction involves the purchase of the mine, preparation plant and supporting assets, and excludes legacy liabilities other than reclamation. The purchase price is subject to customary working capital adjustments. Closing is expected prior to the end of 2018 and is subject to regulatory approvals, certain conditions precedent, including negotiation by Drummond of a collective bargaining agreement with the union-represented workforce, and other customary conditions. Peabody believes the acquisition is consistent with the company's previously stated investment filters: maintain financial strength; fit within the company's strategic focus areas of the PRB, ILB, seaborne met and seaborne thermal; provide expected returns above Peabody's weighted average cost of capital with a reasonable payback period; bring about tangible synergies; and create value for the company's shareholders. The mine adds approximately 2M tons per year of hard coking coal sales that are expected to expand Peabody's met coal volumes and margins, with costs comparable to Peabody's average met coal range. Shoal Creek is positioned on the Black Warrior River with direct access to barge transportation, eliminating trucking or rail requirements. The mine accesses seaborne markets through the Port of Mobile in the Gulf of Mexico serving Asia-Pacific and European steel mills. Peabody intends to finance the transaction with cash on the balance sheet, putting existing assets to work to create additional value for shareholders. The Shoal Creek Mine was developed in 1994 and employs a workforce of approximately 400. The current mine plan accesses 17M tons of reserves under a minimal-capital plan. Shoal Creek uses longwall mining technology to mine both the Blue Creek and Mary Lee coal seams, with low capital investment requirements. Transportation is accommodated through loading Panamax and Cape-sized vessels at the McDuffie Terminal in Mobile, Ala. with substantial available capacity. In 2017, the mine sold 2.1M tons. Shoal Creek's mining costs per ton approximate the average cost of Peabody's metallurgical coal platform. Shoal Creek coal typically prices at or near the high-vol A index. Peabody intends to revise its guidance targets on relevant key metrics following closing of the transaction.
BOFI

Hot Stocks

06:02 EDT BofI Federal Bank awarded regulatory approval for Nationwide deposit acquisition - BofI Federal Bank, the banking subsidiary of Axos Financial, announced that it has received regulatory approval from the Office of the Comptroller of the Currency to proceed with the definitive purchase and assumption transaction previously announced on August 3, 2018. Under the agreement, BofI Federal Bank will purchase from Nationwide Bank certain assets and assume certain liabilities, including approximately $3B of deposit liabilities of Nationwide Bank, in a transaction expected to close no later than November 16, 2018.
LKCO

Hot Stocks

06:01 EDT Luokung Technology announces updates on delay to listing of shares on Nasdaq - Luokung Technology announced that it is working with Nasdaq for an approval of the listing the ordinary shares of the company, which is necessary due to the delayed issuance of 185,412,599 ordinary shares of the company to the stockholders of C Media Limited as contemplated by that Asset Exchange Agreement, dated January 25, 2018. The company's ordinary shares will not be listed for trading until the company receives the approval from Nasdaq.
SNE

Hot Stocks

05:38 EDT Sony's PlayStation Now adds downloading of PS4, PS2 games - Brian Dunn, senior marketing manager, PlayStation Now, says in a blog post: "We are excited to announce that starting today, you will be able to stream as well as download PlayStation Now games to your PS4 system so that you can play both locally and offline, all with a single subscription. Almost all PS4 games in the service, including Bloodborne, God of War 3 Remastered, NBA 2K16, and Until Dawn, will be available for download, in addition to the PS Now lineup of classic PS2 games remastered for PS4. This feature will be gradually rolled out to PS Now subscribers over the next couple of days, so if you don't see the feature on your PS Now today, make sure to check back again soon. Downloaded PS Now games will support all user-purchased DLCs, microtransactions, and add-ons, as well as PS4 Pro enhancements for subscribers using a PS4 Pro system. And remember, you do not need a PlayStation Plus membership for online multiplayer on PS Now - which stays the same for both streaming and downloaded games." Reference Link
PPDF

Hot Stocks

05:26 EDT PPDAI Group announces change in board composition - PPDAI Group announced the resignation of Zehui Liu from the board of the company, effective September 21, due to his own personal reasons. Upon the effectiveness of Liu's resignation, the board will consist of eight directors, including two independent directors.
WBC

Hot Stocks

05:25 EDT Wabco announces vehicle control systems JV in China with FAW Jiefang - WABCO Holdings announced that it has signed an agreement to establish a new joint venture for vehicle control systems with FAW Jiefang Automotive Company to advance the safety and efficiency of commercial vehicles in China. This includes accelerating WABCO's single-piston air disc brake, or ADB, technology leadership in China. An innovative and market-leading commercial vehicle manufacturer, FAW Jiefang has built its world-class manufacturing capabilities, industry expertise and trusted-partner reputation over 60 years. Combined with WABCO's technology leadership and advanced manufacturing capabilities, the joint venture will commence with the manufacture of WABCO's advanced MAXXTM single-piston ADB from 2019. With over six million single-piston ADB systems sold, WABCO is the long-established global market leader for this advanced technology. A major focus of the joint venture will be heavy-duty trucks given WABCO's mastery of single-piston ADB technology for 30,000 Nm applications which have a compact, lightweight design with fewer components and are proven to deliver the highest standards of safety, performance and reliability. Superbly engineered, WABCO's industry-leading, high-performance single-piston ADB technology is best suited for all types of commercial vehicles - light, medium and heavy-duty platforms. This is the first step in a much broader collaboration. WABCO and FAW Jiefang are also planning to cooperate on advanced braking systems development in the areas of autonomous driving, active safety systems and fleet management systems (FMS) to help support commercial vehicle manufacturers and fleets in China to further transform safety and efficiency.
IPSEY EXEL

Hot Stocks

05:17 EDT Ipsen receives positive CHMP opinion for Cabometyx - Ipsen (IPSEY) announced that the Committee for Medicinal Products for Human Use, or CHMP, the scientific committee of the European Medicines Agency, or EMA, provided a positive opinion for Cabometyx as a monotherapy for the treatment of hepatocellular carcinoma, or HCC, in adults who have been previously treated with sorafenib. The CHMP positive opinion will now be reviewed by the European Commission, or EC, which has the authority to approve medicines for the European Union, or EU. In February of 2016, Exelixis (EXEL) and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan. This agreement was amended in December of 2016 to include commercialization rights for Ipsen in Canada. Under the terms of the Collaboration Agreement with Ipsen, Exelixis is eligible to receive a milestone payment of $40M for the approval of the second-line treatment of HCC. This milestone would be paid by Ipsen within 70 days of the approval decision by the European Commission.
BGNE

Hot Stocks

05:13 EDT BeiGene presents results on anti-PD-1 antibody tislelizumab at CSCO - BeiGene presented clinical data on tislelizumab, an investigational anti-PD-1 antibody, in Chinese patients with lung cancers, in two oral presentations at the 21st Annual Meeting of the Chinese Society of Clinical Oncology, or CSCO, in Xiamen, China. "Advanced lung cancer is one of our focus areas for development of tislelizumab, where we hope to have an impact on the way patients are treated both in China and worldwide. This complex and difficult-to-treat disease has proven to be susceptible to treatment with immunotherapies," commented Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene. "The preliminary data presented today demonstrate that tislelizumab is generally well tolerated and has antitumor activity both as monotherapy and in combination with several chemotherapy regimens used in small cell and non-small cell lung cancer patients. We are hopeful that further study of tislelizumab may lead to a new treatment option for a broad array of patients with lung cancers." The multi-center, open-label Phase 2 trial in China of tislelizumab in combination with chemotherapy enrolled 54 patients with previously untreated locally advanced or metastatic lung cancer. All patients received tislelizumab at 200 mg every three weeks, plus platinum doublet until disease progression. Patients with non-squamous non-small cell lung cancer, or NSCLC, received pemetrexed plus platinum; patients with squamous NSCLC received either paclitaxel plus platinum or gemcitabine plus platinum; and patients with small cell lung cancer, or SCLC, received etoposide plus platinum. As of the June 5, 2018 data cutoff, 35 patients remain on treatment. Treatment discontinuation due to adverse events, or AEs, occurred in three patients. Fifty-one patients had at least one post-baseline tumor assessment and were evaluable for efficacy. Objective responses were observed in 56 percent of 16 evaluable patients with non-squamous NSCLC; 80 percent in 15 evaluable patients with squamous NSCLC, cohort A; 67 percent in six patients with squamous NSCLC, cohort B; and 82 percent in 17 evaluable patients with SCLC. Data continue to mature with follow-up. AEs were considered manageable and reversible, with chemotherapy dose modifications or tislelizumab dose holds, except for one fatal event of myocarditis/myositis. Five patients experienced at least one grade greater than or equal to3 AE that were considered to be possibly related to tislelizumab. Immune-related AEs occurred in 13 patients and included hypothyroidism, decreased tri-iodothyronine, hyperthyroidism, pneumonitis, pyrexia, and rash.
TALO

Hot Stocks

05:09 EDT Pemex and Block 7 consortium sign pre-unitization agreement - Petroleos Mexicanos and Talos Energy, as operator of the Block 7 Consortium, are pleased to announce that Pemex and the international Block 7 Consortium have signed a Pre-Unitization Agreement, or PUA, related to certain tracts within the Amoca-Yaxche-03 allocation and the contiguous Block 7 production sharing contract. Both areas are situated in the offshore portion of Mexico's prolific Southeast Basin. This is the first Pre-Unitization Agreement ever to be signed in Mexico. Under the country's recently revamped legal and regulatory framework, this two-year agreement enables information sharing related to the recently announced Zama discovery and its potential extension into Pemex's neighboring block. It also sets a clear path for the signing of a Unit Agreement and Unit Operating Agreement in the event a shared reservoir is confirmed, as it establishes a defined process based on international practices to determine the resulting participation of each party in the potential overall development. As a result of the agreement, both parties will immediately form a Working Group, with the objectives of maximizing operational and informational efficiencies, defining activities on each tract that optimize the collection of data in the area, and reducing any potential hazards, all to maximize the benefits for Mexico. The Working Group will be comprised by legal and technical representatives from the member companies.