Stockwinners Market Radar for October 04, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

ATU

Hot Stocks

20:13 EDT Actuant realigns financial reporting segments - As previously announced, Actuant has realigned its financial reporting segments. The change is effective for the Company's fourth quarter of 2018. The realignment reflects changes in the operating structure of the Company with the combination of the Company's tools and services business and all OEM-related businesses into two operating segments: Industrial Tools & Services and Engineered Components & Systems), respectively. The IT&S segment results from the consolidation of the former Industrial segment, excluding the Precision-Hayes business, with the Hydratight and Mirage businesses from the former Energy segment. The new segment concentrates on product sales and service as well as rental capabilities. Executive Vice President Jeff Schmaling will lead the segment. The EC&S segment is comprised of the former Engineered Solutions segment and now includes the Precision-Hayes business and the former Energy segment businesses, Cortland and Viking. The segment is focused on highly engineered components for transportation, agricultural, construction and other vertical markets and will be led by Executive Vice President, Roger Roundhouse. In addition, the Company's reportable product lines are being reorganized into the following structure: IT&S product lines - Product and Service & Rental; and EC&S product lines - On-Highway; Agriculture, Off-Highway and Other; Rope & Cable Solutions; Concrete Tensioning; and Off-Shore Mooring. The product line reporting change is also effective for the Company's fourth quarter of 2018.
MGM

Hot Stocks

20:10 EDT MGM Resorts Chief Customer Development Officer Robert Baldwin to step down - MGM Resorts International announced that Robert Baldwin, Chief Customer Development Officer of MGM Resorts and CEO and President of CityCenter, will be leaving his positions at both companies later this year.
GPRO

Hot Stocks

19:27 EDT GoPro says HERO7 achieved highest week-one retail sellthrough in company history - GoPro announced that HERO7 Black has achieved the highest week-one retail unit sell-thru of any new camera in the company's history. In addition to HERO7 Black's week-one unit sell-thru performance, social media engagement jumped 80% from last year's launch; and users' feedback on exciting new features like HyperSmooth and TimeWarp Video are overwhelmingly positive. Vloggers like Matti Haapoja, and tech media critics such as Engadget, CNET and Mashable have given HERO7 Black strong accolades. HERO7 Black has also received Editor's Choice Awards from PC Magazine and Tom's Guide.
SGH...

Hot Stocks

19:08 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: SMART Global Holdings (SGH) up 14.1%. ALSO HIGHER: EMCORE Corp (EMKR) up 9.9% after raised Q4 guidance... Chef's Warehouse (CHEF) up 6.3% after entering S&P SmallCap 600 index... Verastem (VSTM) up 4.0% after publication of Phase 3 DUO results in Blood... Paratek Pharma (PRTK) up 2.8% after announcing EMA acceptance of MAA for omadacycline. DOWN AFTER EARNINGS: LeMaitre Vascular (LMAT) down 15.1%... Costco (COST) down 2.5%. ALSO LOWER: Cutera (CUTR) down 16% after lowering FY18 guidance on Juliet headwinds.
PAC

Hot Stocks

19:05 EDT GAP Airports reports September passenger traffic up 12.7% - Grupo Aeroportuario del Pacifico announced preliminary terminal passenger traffic figures for the month of September 2018, compared to traffic figures for September 2017. During September 2018, total terminal passengers increased 12.7% at the Company's 13 airports, compared to the same period of the previous year. Domestic passenger traffic increased by 15.0%, while international passenger traffic increased by 8.7%.
NWN

Hot Stocks

19:04 EDT Northwest Natural Gas raises quarterly dividend to 47.5c per share - The dividend will be paid Nov. 15 to shareholders of record on Oct. 31. The company's indicated annual dividend rate is $1.90 per share.
MNOV

Hot Stocks

19:04 EDT FDA grants MediciNova orphan drug designation to MN-166 for glioblastoma - MediciNova announced that the U.S. Food and Drug Administration has granted orphan-drug designation to MN-166, or ibudilast, as adjunctive therapy to temozolomide for the treatment of glioblastoma.
BOCH

Hot Stocks

19:02 EDT Bank of Commerce to acquire Merchants Holding Company for $37M - Bank of Commerce Holdings and Merchants Holding Company announced the signing of a definitive merger agreement whereby BOCH will acquire Merchants in a stock and cash transaction valued at approximately $37M. As of June 30, 2018, on a pro forma consolidated basis, the combined company would have approximately $1.5Bin assets, $1.2B in deposits, and operate 10 branch offices throughout northern California. Merchants, headquartered in Sacramento, California, is the parent company of The Merchants National Bank of Sacramento, a 97-year-old bank with approximately $218 million in assets as of June 30, 2018. Merchants Bank operates in a single branch location in downtown Sacramento.
ETP ETE

Hot Stocks

18:23 EDT Energy Transfer Partners, Energy Transfer Equity merger granted recommendation - Energy Transfer Partners' (ETP) merger with Energy Transfer Equity (ETE) has been recommended by Institutional Shareholder Services and Glass Lewis & Co., the two independent U.S. proxy advisory firms. The merger will be considered at the October 18 special meeting of ETP unitholders. ETP unitholders of record as of the close of business on September 10 will be entitled to vote at the meeting. Under the terms of the merger agreement, holders of ETP common units will receive 1.28 ETE common units for each ETP common unit they own.
TECK

Hot Stocks

18:17 EDT Teck Resources receives TSX approval for share buyback program - Teck Resources has been informed that the Toronto Stock Exchange has accepted Teck's notice of intention to make a normal course issuer bid to purchase its Class B subordinate voting shares. Under the normal course issuer bid, Teck may purchase up to 40 million Class B Shares during the period starting October 10, 2018 and ending October 9, 2019, representing approximately 7.1% of the outstanding Class B Shares, or 7.9% of the public float, as at October 3, 2018. 566,501,908 Class B Shares were issued and outstanding as at October 3, 2018.
FTNT...

Hot Stocks

18:05 EDT S&P announces changes to S&P 400, 500, 600 indices - S&P Dow Jones Indices will make the following changes to the S&P 500, S&P MidCap 400 and S&P SmallCap 600: S&P MidCap 400 constituent Fortinet (FTNT) will replace Envision Healthcare (EVHC) in the S&P 500, S&P SmallCap 600 constituent ASGN (ASGN) will replace Fortinet in the S&P MidCap 400, and Veritex Holdings (VBTX) will replace ASGN in the S&P SmallCap 600 prior to the open of trading on Thursday, October 11. KKR & Co. (KKR) is acquiring Envision Healthcare in a deal expected to close on or about that date pending final conditions. S&P SmallCap 600 constituent Penn National Gaming (PENN) will replace Convergys (CVG) in the S&P MidCap 400, and The Chefs' Warehouse (CHEF) will replace Penn National Gaming in the S&P SmallCap 600 effective prior to the open of trading on Wednesday, October 10. S&P MidCap 400 constituent SYNNEX (SNX) is acquiring Convergys in a deal expected to close on October 5.
CHEF PENN

Hot Stocks

17:22 EDT Chefs' Warehouse to replace Penn National in S&P 600 at open on 10/10
PENN...

Hot Stocks

17:21 EDT Penn National to replace Convergys in S&P 400 at open on 10/10 - S&P MidCap 400 constituent SYNNEX (SNX) is acquiring Convergys (CVG) in a deal expected to close on October 5.
WHG

Hot Stocks

17:21 EDT Westwood Holdings Group names Terry Forbes new CFO - Westwood Holdings is pleased to announce the promotion of our Vice President of Finance, Murray "Terry" Forbes III, CPA to the position of Chief Financial Officer. Terry takes over from Tiffany Kice, CPA who is resigning to pursue another business opportunity. Terry joined Westwood in December 2014 as Vice President of Finance and has worked closely with Tiffany across all areas of finance, accounting, treasury, tax, internal audit and risk management. He has 18 years of multi-industry experience in the public and private sectors, including 12 years in public accounting.
VBTX ASGN

Hot Stocks

17:19 EDT Veritex to replace ASGN in S&P 600 at open on 10/11
ASGN FTNT

Hot Stocks

17:19 EDT ASGN to replace Fortinet in S&P 400 at open on 10/11
FTNT...

Hot Stocks

17:18 EDT Fortinet to replace Envision Healthcare in S&P 500 at open on 10/11 - KKR & Co. (KKR) is acquiring Envision Healthcare (EVHC) in a deal expected to close on or about that date pending final conditions.
HBM

Hot Stocks

17:12 EDT Hudbay Minerals comments on media report speculating on potential acquisition - "Hudbay Minerals commented on a media report speculating on a potential business acquisition by the company. While the company's policy is to avoid comment on speculation and rumours, Hudbay emphasizes that it has had a consistent strategy of optimizing the value of its current operations and evaluating growth opportunities that are complementary to its current business and that it continues to adhere to this strategy. As described in Hudbay's public disclosure, this may include acquisitions that fit Hudbay's stringent criteria, ranging from early stage exploration to producing mines, provided they are accretive to shareholder value on a per share basis. Further, any acquisitions would ensure that Hudbay retains the financial flexibility and management capacity to maximize the value of its assets and existing growth opportunities."
TFX

Hot Stocks

17:01 EDT Teleflex acquires Essential Medial, terms not stated - Teleflex announced that it has acquired Essential Medical, Inc. Based in Exton, PA, Essential Medical is a privately-held medical device company that has developed and commercialized the CE Marked MANTA Vascular Closure Device specifically designed for closure of large bore arteriotomies following procedures utilizing devices or sheaths ranging in size from 10F to 18F (with maximum outer diameters up to 25F). In its CE Mark study, the MANTA Device demonstrated rapid and reliable hemostasis with its resorbable collagen-based technology and complication rates that were non-inferior to surgical and suture-based closure methods. The MANTA Device is not approved for sale or distribution in the United States.
LMAT

Hot Stocks

16:55 EDT LeMaitre reports Q3 gross margin 71.4% vs 70.8% last year - Reports Q3 EBITDA $5.5M vs. $6.0M last year.
BSET

Hot Stocks

16:38 EDT Bassett Furniture raises share repurchase authorization by nearly $12M - The Board of Directors has increased the company's existing share repurchase authorization by nearly $12M back to the original limit of $20M.
EFII JBL

Hot Stocks

16:38 EDT Electronics for Imaging names William Muir as new CEO - Electronics For Imaging (EFII) announced that its Board of Directors has named William D. Muir as its new CEO. Muir was most recently the COO of Jabil (JBL), a product solutions company. His appointment is effective October 15, when he will also join the Board of Directors. Muir succeeds Guy Gecht, who informed the Board he intended to step down as CEO upon the appointment of his successor, as the Company announced on July 30. Gecht will remain a member of the Board of Directors and will be an advisor to the CEO.
INSM

Hot Stocks

16:33 EDT Insmed extends patent protection in Japan for ALIS till 2033 - Insmed announced that the Japanese Patent Office has issued patent No. 6402097 for the company's amikacin liposome inhalation suspension, ALIS. The claims of the patent relate, in part, to systems for treating pulmonary infections, including nontuberculous mycobacterial infections. This is the eighth patent issued by the JPO to Insmed for ALIS in NTM lung disease, extending patent coverage to May 2033. "This new patent extends the exclusivity of ALIS in Japan by nearly seven and a half years," said Will Lewis, President and Chief Executive Officer of Insmed. "The issuance aligns with our commercial strategy of seeking regulatory approval and launching ALIS in Japan, a region with a relatively high occurrence of NTM lung disease. We will continue to pursue additional patents in Japan and other major markets worldwide to further enhance our intellectual property protection for ALIS, which has the potential to be the first and only inhaled therapy for patients with this devastating disease." The systems described in the Japanese patent include a pharmaceutical formulation containing an aqueous dispersion of liposomal complexed aminoglycoside, which can be amikacin sulfate, with a nebulizer having certain structural features. As previously announced, Insmed received its ninth U.S. patent in February 2018, concerning methods for treating NTM lung infections with ALIS. That U.S. patent will expire in May 2035. ALIS has been approved in the United States by the U.S. Food and Drug Administration under the brand name ARIKAYCE.
CLXT

Hot Stocks

16:33 EDT Calyxt signs agreement with KemX Global to refine high-oleic soybean oil - Calyxt announced that the company has inked an agreement with KemX Global to refine Calyxt's high-oleic soybean oil, an advancement that will allow Calyxt to produce food-grade high-oleic soybean oil as the company's first product that is expected to hit the market in late 2018/ early 2019. Based in Boone, Iowa, KemX Global, with a plant that is organic and non-GMO-certified, has the capacity to refine 115M pounds of premium oils per annum. The plant design incorporates the latest advances in physical refining to reduce the use of chemicals in the oil refining process. Last month, Calyxt announced an agreement with American Natural Processors, or ANP, a leading provider of innovative non-GMO and organic processing of oils, flours and meals, to crush Calyxt's high-oleic soybean variety and produce the company's high-oleic soybean oil. Additionally, in mid-2015, Calyxt received a letter from the United States Department of Agriculture, or USDA, confirming that the company's high-oleic soybean variety is non-regulated, as the product contains no foreign DNA.
GPS...

Hot Stocks

16:28 EDT Gap appoints three new members to board of directors - Gap (GPS) announced the election of three new members to serve on the company's board of directors. Amy Bohutinsky, COO of Zillow Group (Z, ZG), John Fisher, Co-Founder and General Partner of Sansome Partners, and Lexi Reese, COO of Gusto will join Gap's board of directors effective November 1.
KTWO

Hot Stocks

16:26 EDT Gabelli reports 5.61% stake in K2M Group - The aggregate number of securities to which this Schedule 13D relates is 2,455,118 shares, representing 5.61% of the 43,733,631 shares outstanding as reported by K2M Group as of September 11.
ASR

Hot Stocks

16:26 EDT Asur reports total September passenger traffic up 15.4% - Grupo Aeroportuario del Sureste announced that total passenger traffic for September 2018 increased 15.4% when compared to September 2017. Passenger traffic rose 8.3% in Mexico, 56.6% in Puerto Rico and 15.8% in Colombia.
COST

Hot Stocks

16:24 EDT Costco expects to report material weakness in internal control - While Costco is still completing its assessment of the effectiveness of its internal control over financial reporting as of September 2, in its upcoming FY18 annual report, it expects to report a material weakness in internal control. The weakness relates to general information technology controls in the areas of user access and program change-management over certain information technology systems that support the company's financial reporting processes. The access issues relate to the extent of privileges afforded users authorized to access company systems. As of the date of this release, there have been no misstatements identified in the financial statements as a result of these deficiencies, and the company expects to timely file its Form 10-K. Remediation efforts have begun; the material weakness will not be considered remediated until the applicable controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively. The company expects that the remediation of this material weakness will be completed prior to the end of FY19.
SGH

Hot Stocks

16:23 EDT Smart Global reports Q4 gross margin 22.4% vs 21.6% last year
COST

Hot Stocks

16:22 EDT Costco down 3.6% after reporting Q4 earnings results
CUTR

Hot Stocks

16:21 EDT Cutera plunges 16% after slashing guidance due to Juliet headwinds - The company lowered its FY18 revenue view to $165M-$170M from a prior view of $178M-$181M. "A few key factors that negatively impacted our third quarter results are expected to continue into fourth quarter. Given this, we are reducing our 2018 revenue guidance," commented James Reinstein, President and CEO of Cutera, Inc. "Among the factors are headwinds faced by Juliet, our distributed women's health system. We believe there was a clear impact on the overall market following the recent FDA communication to multiple manufacturers. While Cutera did not receive a notification from the agency, we believe our third quarter Juliet sales were negatively affected. Additionally, our hiring goals for US-based capital equipment sales personnel remain unmet. The result is an overburdened sales team, which we also believe will impact the fourth quarter as we hire and train new sales personnel. The newly revised 2018 revenue guidance incorporates these challenges with plans to remediate the latter in preparation for 2019." Reinstein continued, "While the Q3 result did not meet our expectations, it should not overshadow an exceptional launch of our next generation body sculpting offering, truSculpt iD, which delivered a record number of systems in the quarter. We continue to be excited about our prospects in the fast-growing body sculpting segment." Shares of Cutera are down over 16% to $25 per share in after-hours trading.
TSLA

Hot Stocks

16:18 EDT Musk tweets 'Shortseller Enrichment Commission...doing incredible work' - Tesla CEO Elon Musk tweeted, in apparent reference to the SEC: "Just want to that the Shortseller Enrichment Commission is doing incredible work. And the name change is so on point!" Reference Link
COST

Hot Stocks

16:18 EDT Costco reports Q4 total comparable sales increase of 9.5% - Reports Q4 U.S. comparable sales increase of 10.8%, Q4 Canada comparable sales increase of 5.7%, Q4 other international comparable sales increase of 6.7%, and Q4 e-commerce comparable sales increase of 26.2%.
AVB

Hot Stocks

16:17 EDT AvalonBay to sell 80% interest in five Manhattan apartment communities - AvalonBay entered into an agreement to contribute its fee ownership of Avalon Morningside Park, Avalon Bowery Place I, and Avalon Bowery Place II, as well as its leasehold interest in Avalon West Chelsea and AVA High Line, to a newly formed joint venture with an institutional client of global real estate investment manager, Invesco Real Estate, in which AvalonBay will retain a 20% interest and act as the managing member and property manager for the assets. These five communities contain 1,301 apartment homes and approximately 58,000 square feet of retail space in the borough of Manhattan in New York City. The transaction is based on an aggregate asset valuation of approximately $760M and is expected to close before the end of 2018. AvalonBay intends to use the estimated net proceeds of approximately $460M from this transaction for general corporate purposes, which may include the acquisition, development and redevelopment of apartment communities.
TRNC

Hot Stocks

16:17 EDT Tronc announces plan to rename company 'Tribune Publishing Company' - Tronc announced its decision to rename the company Tribune Publishing Company. The change to Tribune Publishing Company will formally take effect on Tuesday, October 9, 2018 at 4:15 pm, Eastern Daylight Time. The company's common stock will resume trading on the NASDAQ with the opening of trading on Wednesday, October 10, 2018 under the ticker "TPCO."
TREE

Hot Stocks

16:16 EDT LendingTree to acquire QuoteWizard.com in roughly $370.2M deal - LendingTree announced that it has entered into a definitive agreement to acquire QuoteWizard.com, LLC, an largest insurance comparison marketplace. The equity purchase has a possible total consideration of $370.2M, which consists of $300M in cash at closing and contingent payments of up to $70.2M, subject to achieving certain growth targets over a three-year period. The acquisition is expected to close in the fourth quarter subject to customary closing conditions and LendingTree intends to fund the acquisition through cash on hand and by drawing on the existing credit agreement. LendingTree expects the acquisition to be accretive to 2019 adjusted earnings per share.
CBOE

Hot Stocks

16:12 EDT Cboe Global Markets reports September options ADV up 3.9% y/y - Reports September futures ADV down 15.9% y/y. Reports September U.S. equities ADV down 3.2%.
EMAN

Hot Stocks

16:11 EDT eMagin names Amal Ghosh CTO - eMagin Corporation announced the promotion of Jeffrey Lucas to President and Dr. Amal Ghosh to Chief Technical Officer. Dr. Ghosh was previously Senior Vice President, Research and Development. Andrew Sculley will continue to serve as eMagin's Chief Executive Officer.
AAU

Hot Stocks

16:10 EDT Almaden Minerals says Rock Creek Mill is ready for shipping in 2019 - Almaden Minerals reported that dismantling of the Rock Creek mill was completed in August and the mill components have since been cleaned, crated and packed to ensure safe storage near the port of Nome, Alaska. The Rock Creek mill is now fully owned by Almaden and ready for anticipated shipping to Mexico in 2019. This work has been completed by Dynamic Engineering Services on time and on budget. The Ixtaca deposit feasibility study, or FS, is nearly complete and is anticipated in 2018. The FS will incorporate the positive results of ore sorting tests that were reported earlier as well as several other opportunities that were identified in the FS work program. As reported previously, Almaden is also in the final stage of preparing an Environmental Impact Assessment for Ixtaca, and is incorporating the most recent updates contained in the FS, into the MIA. Almaden expects to submit the MIA this year.
AKCA IONS

Hot Stocks

16:08 EDT Akcea, Ionis announce Canadian approval of Tegseditm - Akcea Therapeutics (AKCA), an affiliate of Ionis Pharmaceuticals, and Ionis Pharmaceuticals (IONS), announced that Tegseditm is now approved in Canada for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis.
WAAS

Hot Stocks

16:08 EDT AquaVenture signs water agreement in Anguilla - AquaVenture's operating segment Seven Seas Water entered into an agreement with the Water Corporation of Anguilla, the public water utility of Anguilla, to supply potable water under a 10-year contract. Water production, which will commence immediately, will be at an initial capacity of 500 thousand gallons per day and expand to 750 thousand gallons per day within the first several months of commencement. The agreement provides for an additional expansion for a total design capacity of 1 million gallons per day during the term.
RPM

Hot Stocks

16:08 EDT RPM increases quarterly cash dividend 9.4% to 35c per share - RPM International announced at its annual meeting of stockholders that its board declared a regular quarterly cash dividend of 35c per share, payable on October 31 to stockholders of record as of October 16. This payment represents a 9.4% increase over the 32c quarterly cash dividend paid at this time last year.
HPP NFLX

Hot Stocks

16:07 EDT Hudson Pacific leases its EPIC Officer tower in Hollywood to Netflix - Hudson Pacific Properties (HPP) announced that Netflix (NFLX) has signed a lease to fully occupy all 327,913 square feet of EPIC, its 13-story office development located in Hollywood, California. Netflix will occupy the building in phases beginning in January 2020, and the lease concludes in 2031. Netflix also signed a coterminous lease extension for 325,757 square feet of office space at ICON and 91,953 square feet of office space at CUE, both of which are Hudson Pacific assets located on the landmark Sunset Bronson Studios lot, across the street from EPIC. Sunset Bronson is also owned and operated by Hudson Pacific and is home to long-term tenants CBS and KTLA. EPIC, which is currently under construction with delivery anticipated in the first quarter of 2020, is a new model of Class A, creative high-rise office space. Designed by Gensler, the vertically stacked and terraced building is a one-of-a-kind design with spectacular panoramic views of the Hollywood Hills, the Pacific Ocean and downtown Los Angeles. The floor-to-ceiling windows and operable glass doors provide direct access to exterior terraces, fire pits, collaboration areas and a rooftop deck with catering pantry. EPIC offers over 25,000 square feet of usable outdoor space, creating seamless indoor-outdoor flow unlike any other high-rise in Los Angeles.
AKCA

Hot Stocks

16:07 EDT Akcea Therapeutics announces Canadian approval of Tegseditm - Akcea Therapeutics (AKCA), an affiliate of Ionis Pharmaceuticals, and Ionis Pharmaceuticals (IONS), announced that Tegseditm is now approved in Canada for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis.
OPHT

Hot Stocks

16:07 EDT BML Investment Partners reports 5.11% passive stake in Ophthotech
VSTM

Hot Stocks

16:06 EDT Verastem announces publication of Phase 3 DUO results in the journal Blood - Verastem, Inc. announced that the results of the Phase 3 DUO study, which evaluated COPIKTRA capsules versus ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, was published online in the peer-reviewed journal Blood. COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase, and the first approved dual inhibitor of PI3K-delta and PI3K-gamma. COPIKTRA was approved by the U.S. Food and Drug Administration on September 24th, 2018 for the treatment of relapsed or refractory CLL/SLL after at least two prior therapies. The COPIKTRA NDA was supported by clinical data from the randomized, multicenter, open-label Phase 3 DUO study, which compared COPIKTRA versus ofatumumab in 319 adult patients with CLL or SLL after at least one prior therapy. The study randomized patients with a 1:1 ratio to receive either COPIKTRA 25mg BID until disease progression or unacceptable toxicity, or ofatumumab for 7 cycles. "Continued research for new treatment options is important to address the needs of patients with relapsed or refractory CLL/SLL once they have progressed," said Ian Flinn, M.D., Ph.D., Director of the Lymphoma Research Program at Sarah Cannon Research Institute, lead investigator of the Phase 3 DUO study and lead author of the manuscript. "Duvelisib is an important addition to the evolving treatment paradigm for patients with CLL/SLL and we are delighted to have the study results published in Blood to share with the medical and scientific communities."
PRTK

Hot Stocks

16:06 EDT Paratek Pharmaceuticals announces EMA acceptance of MAA for omadacycline - Paratek Pharmaceuticals announced the acceptance of the submission to the European Medicines Agency, or EMA, of the Marketing Authorization Application, or MAA, for omadacycline. Paratek is seeking approval of omadacycline, a modernized tetracycline, for the treatment of community-acquired bacterial pneumonia, or CABP, and acute bacterial skin and skin structure infections. Omadacycline is a once-daily oral and intravenous broad spectrum antibiotic approved under the tradename Nuzyra in the United States. The MAA is supported by the company's Phase 3 program for omadacycline, which included three pivotal registration studies: two studies in ABSSSI and one study in CABP. Omadacycline met all required EMA primary endpoints in each study and demonstrated a generally safe and well-tolerated profile. In the U.S., the FDA approved Nuzyra in October for the treatment of adults with community-acquired bacterial pneumonia and acute skin and skin structure infections.
PHH

Hot Stocks

16:01 EDT PHH Corp. trading resumes
BBW WMT

Hot Stocks

15:54 EDT Build-A-Bear announces additions to company's outbound licensing program - Build-A-Bear Workshop (BBW) , in partnership with licensing agent Brand Activation Consulting, has launched new, D-I-Y plush sets and a mini blind-box plush collection from licensee Just Play, a leader in the children's consumer goods industry, both of which are on shelves now exclusively at U.S. Walmart stores (WMT) and Walmart.com.
SJT

Hot Stocks

15:48 EDT San Juan Basin Royalty Trust trading resumes
LYV

Hot Stocks

15:36 EDT Ticketmaster 'welcomes and looks forward' to FTC workshop on online ticketing - Live Nation's Ticketmaster announced that it "welcomes and looks forward to participating in the FTC workshop on online ticketing in March 2019. To be clear, this is an industry wide workshop - not a probe. We encourage other ticketing companies to take part in educating consumers and lawmakers on the opportunities and challenges in the ticketing industry and to join us in further action to improve the consumer ticket buying experience, including aggressive enforcement of the BOTS Act, the elimination of speculative ticket sales and restrictions on deceptive marketing and misleading ticketing URLs."
RPM

Hot Stocks

15:16 EDT RPM increases quarterly cash dividend 9.4% to 35c per share - RPM International announced at its annual meeting of stockholders that its board declared a regular quarterly cash dividend of 35c per share, payable on October 31 to stockholders of record as of October 16. This payment represents a 9.4% increase over the 32c quarterly cash dividend paid at this time last year.
SJT

Hot Stocks

15:10 EDT San Juan Basin Royalty Trust trading halted, news pending
ESSA

Hot Stocks

15:05 EDT ESSA Bancorp CEO Gary Olson sells over $100K in company stock - ESSA Bancorp CEO Gary Olson disclosed in a filing that he had sold 6,243 shares of ESSA Bancorp at an average price of $16.25 per share on October 3. The total transaction value of the sale was $101,443.
SMCI...

Hot Stocks

15:01 EDT Super Micro Computer refutes claims in Bloomberg article - Super Micro Computer, Inc. (SMCI) announced that it "strongly refutes reports that servers it sold to customers contained malicious microchips in the motherboards of those systems." In an article today, it is alleged that Supermicro motherboards sold to certain customers contained malicious chips on its motherboards in 2015. "Supermicro has never found any malicious chips, nor been informed by any customer that such chips have been found," the company stated, adding that "each company mentioned in the article (Supermicro, Apple, Amazon and Elemental) has issued strong statements denying the claims." Apple (AAPL) stated on CNBC, according to Super Micro: "We are deeply disappointed that in their dealings with us, Bloomberg's reporters have not been open to the possibility that they or their sources might be wrong or misinformed. Our best guess is that they are confusing their story with a previously reported 2016 incident in which we discovered an infected driver on a single Supermicro server in one of our labs. That one-time event was determined to be accidental and not a targeted attack against Apple." Steve Schmidt, Chief Information Security Officer at Amazon Web Services (AMZN) stated, according to Super Micro: "As we shared with Bloomberg BusinessWeek multiple times over the last couple months, at no time, past or present, have we ever found any issues relating to modified hardware or malicious chips in Supermicro motherboards in any Elemental or Amazon systems." Supermicro said it has never been contacted by any government agencies either domestic or foreign regarding the alleged claims. "Supermicro takes all security claims very seriously and makes continuous investments in the security capabilities of their products. The manufacture of motherboards in China is not unique to Supermicro and is a standard industry practice. Nearly all systems providers use the same contract manufacturers. Supermicro qualifies and certifies every contract manufacturer and routinely inspects their facilities and processes closely," the company added.
SMCI

Hot Stocks

14:59 EDT Super Micro Computer refutes claims in Bloomberg article
RPM

Hot Stocks

14:53 EDT RPM announces promotion of Lonny DiRusso to chief information officer - RPM International announced that it has promoted Lonny DiRusso to vice president and chief information officer, Matthew Franklin to vice president - information technology, and Gordon Hyde to vice president - operations. "These promotions are being made as part of an organizational realignment that will support our operating improvement initiatives," the company stated.
AMC

Hot Stocks

14:51 EDT AMC reports over 400,000 enrolled members for Stubs A-List program - AMC Theatres announced that AMC Stubs A-List has crossed more than 400,000 enrolled members. Adam Aron, AMC CEO and President, said, "While we do not plan to issue A-List enrollment statistics on a weekly basis, our hitting more than 400,000 enrolled members only three months and a week after launching the program is an enormous milestone. Those who have been following our progress with A-List are aware that we had originally expected 500,000 enrollments at the one-year mark and 1,000,000 enrollments at the two-year mark. Above our wildest hopes, in just 14 weeks, we have achieved 80% of our one-year goal and 40% of our two-year goal. This all bodes well for the future of increased moviegoing in America."
BX

Hot Stocks

14:49 EDT Blackstone, Peel weigh taking Intu Properties private - The Peel Group, The Olayan Group, and Brookfield Property Group on behalf of funds or vehicles which are managed or advised by it note the recent press speculation and confirm that the Consortium is in the preliminary stages of considering a possible cash offer for the issued share capital of Intu Properties not already owned by members of the Consortium. The Consortium's consideration of the Possible Offer is at a preliminary and exploratory stage and no approach has been made to the Board of Intu. There can be no certainty that any transaction will ultimately be forthcoming, nor can there be any certainty as to the terms of any such transaction.
MNK PX

Hot Stocks

14:37 EDT Mallinckrodt selloff on Praxair FDA approval seen as overreaction - Shares of Mallinckrodt (MNK) are sliding following the FDA approval of an abbreviated new drug application for Praxair's (PX) Noxivent. Commenting on the news, Stifel analyst Annabel Samimy argued that the stock selloff is an overreaction as its competitor will face high commercial hurdles to displace the INOmax System and noted that consensus estimates have reflected potential commercial competition for well over a year. Voicing a similar opinion, her peer at BMO added that there are several important factors to consider that would appear to mitigate the generic risks and make the situation manageable for Mallinckrodt. SELLOFF AN OVERREACTION: Noxivent's filing as a generic has given investors pause that the gas will be used as a substitute to Mallinckrodt's nitrous oxide in the INOmax System, the leading nitric oxide vasodilator for respiratory failure in term/near-term infants, Stifel's Samimy said in a research note. The analyst pointed out, however, that Noxivent cannot be interchanged with the nitric oxide gas used in the INOmax System, and thus far, she has not seen a 510(k) approval from the FDA for Praxair's device. Furthermore, Samimy highlighted that the pending Praxair system will be another branded competitor and not a generic substitute as the Street reaction implies. The pending approval of this ANDA was well known, she contended, adding that she believes estimates have reflected potential competition for well over a year. Overall, the analyst sees the stock move as an "overreaction to a known event" and believes Mallinckrodt is well-positioned to defend its share. Samimy reiterated a Hold rating and $30 price target on the latter's shares. Also commenting on Praixar's Noxivent news, BMO Capital analyst Gary Nachman said in a research note of his own that the generic was expected to be approved at some point, although the timing was uncertain. Moreover, the analyst highlighted that there are several important factors to consider that would appear to mitigate the generic risk and make this situation manageable for Mallinckrodt. Praxair will need its device to be approved in order to have a generic version of INOmax, he noted, adding that he fully expects the device to be approved sometime soon. Additionally, the analyst pointed out that litigation is still ongoing with Mallinckrodt's appeal of the decision that favored Praxair regarding the INOmax patents, with the former indicating that the appeal is expected to be resolved sometime in the first half of 2019. A Praxair generic launch before then would be "at risk," Nachman argued. The analyst believes "this is a very challenging market" with many natural barriers including all the support that Mallinckrodt provides the neonatal intensive care units at hospitals. Nachman reiterated an Outperform rating and $37 price target on Mallinckrodt. PRAXAIR APPROVAL REINFORCES OVERHANG: Noting that INOmax is Mallinckrodt's second largest product, representing approximately $131M of sales in the second quarter, Wells Fargo analyst David Maris told investors that the approval of a generic version of its gas was something that was expected, although the exact timing was unexpected. The analyst pointed out that he was already modelling a slowdown in growth in 2019 for Mallinckrodt but is not modelling "a major loss" of market share. Overall, Maris believes that the Praxair approval "certainly reinforces an overhang issue" and brings market share risk closer to reality, and as such will likely have a negative impact on the shares. He reiterated a Market Perform rating and $30 price target on Mallinckrodt's shares. PRICE ACTION: In afternoon trading, shares of Mallinckrodt have plunged over 18% to $25.43.
HZNP

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13:59 EDT Horizon Pharma rises after presenting data on investigational TED treatment - Shares of Horizon Pharma are higher after the company announced new data from the Phase 2 clinical trial of teprotumumab for people living with moderate-to-severe active thyroid eye disease, or TED. The results of this investigational medicine, presented during an oral session at the American Thyroid Association Annual Meeting, showed that a majority of patients that had reductions in proptosis at week 24 maintained these reductions 48 weeks following the study completion, or nearly a year off therapy, the company said. "Teprotumumab has the potential to be an impactful treatment for people living TED and the first therapy to demonstrate reduction in proptosis. We are encouraged by these data, which suggest proptosis reductions could be maintained in a majority of responders for nearly a year off therapy. Through our ongoing confirmatory Phase 3 trial and extension study, we expect to gain a deeper understanding of the effect of additional treatment for those considered non-responders as well as those who may benefit from retreatment," said Elizabeth Thompson, VP of clinical development, rare disease, for Horizon. In afternoon trading, Horizon Pharma is up 27c, or 1.4%, to $19.20 per share.
TSLA

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13:45 EDT Tesla says one accident registered for every 3.34M autopilot miles in Q3 - Tesla stated in a Q3 'Vehicle Safety Report' issued via its blog: "Earlier this year, when we made the decision to begin publishing our safety data on a regular basis, we designed and introduced a completely new telemetry stream for our vehicles to facilitate these reports. This new data stream allows us to gather the most critical fleet-wide statistics from the exact moment a crash-related event is detected by our system. While there are still some unique cases in which crash data may not be available to us through this channel, we believe this system currently provides the best framework for safety reporting on an ongoing basis. Here's a look at the data we're able to report for Q3: Over the past quarter, we've registered one accident or crash-like event for every 3.34 million miles driven in which drivers had Autopilot engaged; For those driving without Autopilot, we registered one accident or crash-like event for every 1.92 million miles driven. By comparison, the National Highway Traffic Safety Administration's (NHTSA) most recent data shows that in the United States, there is an automobile crash every 492,000 miles. While NHTSA's data includes accidents that have occurred, our records include accidents as well as near misses (what we are calling crash-like events). Moving forward, we will publicly release these accident figures on a quarterly basis." Reference Link
MFC

Hot Stocks

13:36 EDT Short-seller Muddy Waters takes aim at Manulife Financial on lawsuit risks - Muddy Waters announced a new short position in Manulife Financial (MFC), citing lawsuit risks after the company's life insurance subsidiary concluded a trial with a hedge fund that could lead to billions in losses. Muddy Waters' Carson Block acknowledged, however, that there is no "wrongdoing" by the company in an interview with Bloomberg. Responding to the short report, the company said it disagrees with Muddy Waters' conclusions and believes it "will prevail" in lawsuit against company. LAWSUIT RISKS: In a new report posted on its website, the short-selling firm said, "Muddy Waters is short Manulife Financial Corporation because we believe its securities do not price in the significant risk posed by the Mosten Trial. Trials are always hard to handicap; however, we believe there is a reasonable chance that Mosten prevails." The company's life insurance subsidiary just concluded a trial with a hedge fund that could lead to billions in losses, the short-seller argued, noting that a verdict is expected this year. "At issue is one of Manulife's insurance contracts, which was purchased by a hedge fund called Mosten Investment LP. Should Mosten prevail, it could lead to billions of dollars of losses at Manulife, which could greatly impair its future earnings and affect its capital adequacy ratios. The trial judge is expected to render his decision by the end of 2018. The crux of the litigation is not about a particular claim. Rather, the issue is whether Mosten -- or other owners of similar policies -- can force Manulife to provide it with what would likely be one of the highest yielding short-term investment grade products in the developed world," the report said. "Mosten owns a specific insurance contract from 1997, the Architect IIe universal life insurance policy. Mosten argued it can deposit an unlimited amount of money with Manulife and receive an annualized guaranteed return of at least 4.00% -- and possibly a good deal higher -- with one-month liquidity, according to its reading of the contract. If Mosten prevails, it could sell an unlimited amount of limited partnership interests backed by the Manulife insurance contract, and likely become the most lucrative money market fund in the developed world!" MANULIFE DISAGREES WITH MUDDY WATERS' CONCLUSIONS: In a statement, Manulife Financial said that "The Muddy Waters report is a short seller's attempt to profit at the expense of our shareholders, and we disagree with its conclusions. Manulife continues to believe that Mosten's position is legally unfounded. We firmly believe that the consumers purchasing universal life policies, and the insurers issuing these policies, never intended to have the policies function as deposit or securities contracts. We have a sound, highly rated global franchise. We expect we will prevail with respect to this matter and that it will not affect our business operations or our ability to meet obligations to our customers, vendors and other key stakeholders." PRICE ACTION: In afternoon trading, shares of Manulife Financial have dropped 3.6% to $17.40.
WHLR

Hot Stocks

13:29 EDT Stilwell Group: Wheeler REIT's capital structure 'has always been poor' - The Stilwell Group, the largest shareholder of Wheeler Real Estate Investment Trust, announced that it has released the following statements delivered by Joseph Stilwell to the Wheeler Board of Directors at the company's 2018 Annual Meeting of Shareholders held yesterday, October 3: "The capital structure of Wheeler has always been poor. The issuance of a substantial additional amount of the Series D preferred last January - to buy JANAF - which we view as a vanity project for the folks in Virginia Beach - made it a disaster to [Wheeler's common] shareholders. The Series D preferred has a 'death spiral' provision that takes effect in just under five years and will wipe out the common shareholders - giving the company about three years to find a solution. Six of you were here, and you all voted for it. If you were ignorant of the provision, to us - to me - you were grossly negligent. If you knew of the provision, you were recklessly negligent. The most charitable explanation we can imagine is that each of you was dead asleep. It's been our experience that the directors who create problems are seldom the ones to fix those problems. While I hope you prove me wrong in the next year, the signs aren't promising. Westport Capital now has a second director added to the Board; yet Westport's first director voted for all the bad stuff, and you renominated him. At Stilwell, we'd fire someone like that. And North Star's Andy Jones is a very passive guy who's already swapped out a part of his common shares into preferred shares. And of course, the other six of you caused this mess. I approached this election in too lighthearted a manner - a mistake I will not make next year."
MEET

Hot Stocks

13:05 EDT Meet Group jumps over 5% after announcing new livestreaming video milestones - The Meet Group provided an update on its livestreaming video platform, ahead of the company's presentation at the B. Riley FBR Consumer & Media Conference in New York City. "We've made tremendous progress in the last year," said Geoff Cook. "As of September, our video business is now generating more than $48M on an annualized basis - growing from zero in October of last year. It is easily the fastest-growing new product in our history, and we believe we can continue to grow it from here. "For the month of September, daily live video users averaged more than 900,000, of which an average of 125,000 were broadcasting. We've also continued to grow total minutes of livestreaming content," added Cook. For the month of September: Annualized video revenue run-rate exceeded $48 million, an increase of 17% versus the $42 million we last reported in August. Daily video users exceeded 900,000, an increase of 20% from the 750,000 we last reported in July. Increased vDAU reflects growing video penetration at LOVOO. Daily video users as a share of mobile daily active users exceeded 20% for the portfolio. Total daily time spent in video exceeded 25 million minutes. "Livestreaming video is revolutionizing the way people connect," continued Cook. "I believe it is a media form that will rival traditional television for size and diversity, with channels developing for video games, dating, contests, and news, to name just a few. The rise of services like Twitch, HQ, and MOMO, I believe, are indicative of this trend, as is our substantial progress growing a global social entertainment livestreaming network. Shares of the Meet Group are up 5.3% to $5.16 per share in afternoon trading.
MFC

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12:58 EDT Manulife Financial: Mosten's position 'legally unfounded'
MFC

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12:58 EDT Manulife Financial says has 'sound, highly rated global franchise'
MFC

Hot Stocks

12:57 EDT Manulife Financial says 'disagrees' with conclusions of Muddy Waters report - Manulife Financial said in a statement: "The Muddy Waters report is a short seller's attempt to profit at the expense of our shareholders, and we disagree with its conclusions. Manulife continues to believe that Mosten's position is legally unfounded. We firmly believe that the consumers purchasing universal life policies, and the insurers issuing these policies, never intended to have the policies function as deposit or securities contracts. We have a sound, highly rated global franchise. We expect we will prevail with respect to this matter and that it will not affect our business operations or our ability to meet obligations to our customers, vendors and other key stakeholders."
AA...

Hot Stocks

12:47 EDT Norsk Hydro says closing Alunorte will take 30-36 days, restarting 60-90 days - Norsk Hydro (NHYDY) said in an email to Bloomberg that it started the process of closing the Alunorte alumina refinery in Brazil on October 3 and that the closing process will take 30-36 days. Restarting Alunorte would take 60-90 days, the news service added that it was told. Yesterday, following the initial news that Alunorte was preparing for full curtailment of its operation, shares of Alcoa (AA) jumped and those of Century Aluminum (CENX) sank.
RHHBY

Hot Stocks

12:41 EDT Roche's Genentech announces FDA approval of Hemlibra for Hemophilia A - Genentech, a member of the Roche Group, announced that the U.S. FDA has approved Hemlibra for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A without factor VIII inhibitors. Hemlibra is now the only prophylactic treatment for people with hemophilia A with and without factor VIII inhibitors that can be administered subcutaneously and at multiple dosing options. This approval is based on positive results from the Phase III HAVEN 3 and HAVEN 4 studies. Hemlibra prophylaxis led to statistically significant and clinically meaningful reductions in treated bleeds compared to no prophylaxis and across all other bleed-related endpoints in the HAVEN 3 study, and showed a clinically meaningful control of bleeding in the HAVEN 4 study. Hemlibra is now available to people in the U.S. who have hemophilia A without factor VIII inhibitors.
MCD...

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12:29 EDT Bernie Sanders asks McDonald's to follow Amazon in paying $15 per hour - Senator Bernie Sanders, in a letter to CEO Steve Easterbrook, asked McDonald's (MCD) to follow Amazon.com (AMZN) and Disney (DIS) in boosting the minimum wage its pays its employees to $15 per hour. "If McDonald's raised the minimum wage to $15 an hour and respected the constitutional rights of your workers to form a union it would set an example for the entire fast food industry to follow," Sanders wrote to the executive. "Today, McDonald's pays wages that are so low that many of its workers need Food Stamps," the Senator told Easterbrook. McDonald's in midday trading is up 27c to $164.97. Reference Link
BPY

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12:20 EDT Brookfield consortium confirms preliminary stages of considering Intu offer - The Peel Group, The Olayan Group and Brookfield Property Group note the recent press speculation and confirm that the consortium is in the preliminary stages of considering a possible cash offer for the issued share capital of Intu not already owned by members of the consortium. The consortium said its consideration of the possible offer "is at a preliminary and exploratory stage and no approach has been made to the Board of Intu." It added that "there can be no certainty that any transaction will ultimately be forthcoming, nor can there be any certainty as to the terms of any such transaction."
SYNC...

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12:19 EDT Synacor, Cheddar enable Hulu with Live TV access to live business, tech news - Post cable networks company Cheddar and Synacor announced that subscribers of Hulu with Live TV and YouTube TV will have full access to Cheddar's live and on demand programming at no additional charge via the Cheddar web site, as well as mobile and TV apps.
CCOEY...

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12:06 EDT Capcom's 'Mega Man' IP to be adapted into movie distributed by Fox - Capcom (CCOEY) announced that its popular "Mega Man" IP is scheduled to be adapted into a live-action Hollywood film for the first time. The feature film, tentatively titled "MEGA MAN," will be written and directed by Henry Joost and Ariel Schulman, and is scheduled to be distributed by 20th Century Fox (FOX). Chernin Entertainment, responsible for the Planet of the Apes series, will be producing it with Masi Oka, of Heroes fame. Based on the influential and globally beloved "Mega Man" franchise, Capcom aims to appeal to a diverse audience, including not only game players but action movie fans as well, with an adaptation that maintains the world of the "Mega Man" games, while incorporating the grand production and entertainment value that Hollywood movies are known for.
WMB

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12:03 EDT FERC approves Williams's request to put Atlantic Sunrise into full service - Williams reported that the Federal Energy Regulatory Commission, FERC, has approved the company's request to place its Atlantic Sunrise project into full service. The company plans to place the project into full service on Oct. 6. Backed by long-term shipper commitments, the historic project increases the design capacity of the Transco pipeline, the largest-volume natural gas pipeline system in the United States, by 1.7B cubic feet per day to 15.8B cubic feet per day. In the process, the project further strengthens and extends the bi-directional flow of the Transco system, directly connecting Marcellus gas supplies with markets as far south as Alabama. "This project makes the largest-volume pipeline system in the country even larger, further executing on our strategy to connect premier natural gas supply areas with the best markets in the country," said Alan Armstrong, Williams president and chief executive officer. "The project is significant for Pennsylvania and natural gas-consuming markets all along the East Coast, alleviating infrastructure bottlenecks and providing millions of consumers direct access to one of the most abundant, cost-effective natural gas supply sources in the country."
PKX

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12:00 EDT Posco falls -8.7% - Posco is down -8.7%, or -$5.71 to $60.17.
MNK

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12:00 EDT Mallinckrodt falls -17.2% - Mallinckrodt is down -17.2%, or -$5.36 to $25.75.
RTEC

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12:00 EDT Rudolph Technologies falls -17.5% - Rudolph Technologies is down -17.5%, or -$4.20 to $19.76.
CLDR

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12:00 EDT Cloudera rises 11.8% - Cloudera is up 11.8%, or $2.02 to $19.10.
ITG

Hot Stocks

12:00 EDT ITG rises 18.8% - ITG is up 18.8%, or $4.15 to $26.21.
BKS

Hot Stocks

12:00 EDT Barnes & Noble rises 21.3% - Barnes & Noble is up 21.3%, or $1.16 to $6.62.
STZ...

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11:28 EDT Constellation Brands CEO: 'Our core business is stronger than ever' - Constellation Brands management said investment in Canopy Growth was an offensive, not defensive move and there is "no evidence" of alcohol cannibalization from marijuana.
ITG VIRT

Hot Stocks

11:27 EDT ITG jumps 11% after Bloomberg says Virtu pursuing takeover - Investment Technology Group (ITG) shares jumped after Bloomberg reported that Virtu Financial (VIRT) is seeking to acquire the company. Virtu is working with a financial adviser to pursue ITG, Bloomberg said, citing people familiar with the matter. The companies have recently been holding talks about a deal, sources told Bloomverg, but no decision has been made and ITG could decide to remain independent. Shares of ITG jumped 11%, or $2.49, to $24.58 before being halted for volatility. Shares of high-speed trading firm Virtu are up 6%, or $1.29, to $21.94 following the report.
ITG

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11:25 EDT Investment Technology Group trading resumes
ITG

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11:20 EDT Investment Technology Group trading halted, volatility trading pause
LYV EBAY

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11:14 EDT FTC to hold workshop examining online event ticket sales - The staff of the Federal Trade Commission will examine consumer protection and competition issues related to the online event-ticket marketplace at a public workshop on March 27, 2019. The online event ticket industry has been a frequent topic of consumer and competitor complaints, and FTC staff is seeking public input in advance of the workshop, including possible discussion topics and potential participants.The workshop will feature opening remarks by Commissioner Rebecca Kelly Slaughter and will bring together a variety of stakeholders, including industry representatives, consumer advocates, trade associations, academics and government officials, to discuss problematic practices in the online event ticket marketplace. The FTC said: "The Commission has a strong interest in protecting consumer confidence in the online marketplace. Issues that frequently arise in connection with online event ticket sales include practices that prevent consumers from obtaining tickets, mislead consumers about price or availability, or mislead consumers about the entity from which they are purchasing. The U.S. Government Accountability Office recently issued a report summarizing these issues. The workshop will discuss the current state of the online event ticket marketplace, shed light on industry-wide advertising and pricing issues, and explore ways to address deception beyond traditional law enforcement." Publicly traded companies that participate in this space include Live Nation (LYV), StubHub (EBAY).
STZ...

Hot Stocks

11:13 EDT Constellation Brands expects marijuana decriminalization in U.S. - Constellation Brands CEO says "no doubt" that there is a bright future in marijuana.
KEYS

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11:03 EDT Keysight Technologies, Bluetest extend collaboration to 5G new radio solutions - Keysight Technologies has extended the company's collaboration with Bluetest to integrate Keysight's first-to-market 5G new radio network emulation solutions with Bluetest's reverberation chamber for Over-the-Air testing of 5G NR devices in sub-6GHz frequency bands. The integration of Keysight's 5G-based network emulation solutions with Bluetest's reverberation chambers, enables mobile operators, and their respective mobile device ecosystems, to quickly, easily and repeatably verify the data throughput performance of 5G NR devices operating in FR1. This leads to fast and cost-effective validation of 5G mobile devices.
STZ...

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10:55 EDT Constellation Brands CEO says cannabis market opening up faster than anticipated - Comments provided during Q2 earnings conference call.
STZ

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10:48 EDT Constellation Brands CEO says cannabis market opening up faster than anticipated - Comments provided during Q2 earnings conference call.
ORGS

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10:45 EDT Orgenesis, HekaBio enter into license agreement in Japan - Orgenesis announced that it has entered into a License Agreement with HekaBio, pursuant to the Joint Venture Agreement the parties entered into on July 10, 2018. Under the License and Joint Venture Agreements, HekaBio and Orgenesis will collaborate in the clinical development and commercialization of regeneration and cell and gene therapeutic products in Japan. In consideration for the License, HekaBio shall pay Orgenesis royalties equal to ten percent of all net sales and twelve percent of any sublicense receipts. Under the License and Joint Venture Agreements, HekaBio will fund, at its sole expense, all costs associated with obtaining the requisite regulatory approvals for conducting clinical trials, as well as performing all clinical and other testing required for market authorization of the products in Japan.
NVO LLY

Hot Stocks

10:42 EDT Novo Nordisk drops after Eli Lilly reports impressive diabetes drug data - Shares of Novo Nordisk (NVO) plunged in morning trading after Eli Lilly (LLY) said its new diabetes drug proved successful in reducing weight and lowering blood sugar in a mid-stage trial. SUCCESS IN DRUG TRIAL: Eli Lilly said this morning that its dual GIP and GLP-1 receptor agonist, a two-in-one drug, showed "strong" and "meaningful" reduction in blood sugar and weight loss in people with type 2 diabetes in a Phase 2b trial. The six-month data, which were presented at the 54th annual meeting of the European Association for the Study of Diabetes and simultaneously published in The Lancet, showed average HbA1c reductions of up to 2.4% and an average weight reduction up to 12.7%. At 26 weeks, the primary analysis of the trial showed a "robust" dose response compared to placebo throughout the entire dose range of GIP/GLP-1 RA included in the study, and a further study examining an optimal titration schedule to help manage GI side effects was conducted and will be presented next year. Eli Lilly said Phase 3 studies for type 2 diabetes are expected to begin no later than early 2019 and will complete in late 2021 and said it is evaluating its next steps in the study of GIP/GLP-1 RA for obesity and other conditions. WHAT'S NOTABLE: Novo Nordisk current GLP-1 products include Victoza and Omzepic, and the company is also developing an oral version of semaglutide, the active ingredient in Ozempic. BMO Capital Markets analyst Alex Arfaei said Wednesday in a research note that the treatment provides Eli Lilly with an opportunity to be competitive with Novo's semaglutide franchise and should meaningfully strengthen the company's growth prospects in the GLP-1 market. PRICE ACTION: Shares of Novo Nordisk trading in New York dropped 7.2% to $43.35, while Eli Lilly shares gained 4% to $112.94.
AMCX

Hot Stocks

10:37 EDT Goldman sees no life in Walking Dead ratings, says sell AMC - Shares of AMC Networks (AMCX) are sliding after Goldman Sachs analyst Drew Borst downgraded the stock to Sell on estimate risk as The Walking Dead ratings decline and given heightened competition for scripted original series and viewers. SELL AMC: In a research note to investors this morning, Goldman Sachs' Borst downgraded AMC Networks to Sell from Neutral and lowered his price target on the shares to $61 from $64. The analyst expects AMC to underperform peers, with his price target implying 8% downside to current levels. Weakness in National Networks advertising from The Walking Dead ratings declines and heightened competition for scripted original series and viewers, as well as slowing revenue growth and higher content and marketing costs, create risk to consensus estimates, Borst contended. Furthermore, the analyst noted that he does not see a near-term catalyst to drive a multiple re-rating. While the recent rally off the valuation near-lows is largely predicated on M&A in his view, Borst is also skeptical about a premium takeout in the near-term because AMC is a controlled company and there is limited strategic value for an ad-supported basic cable network with a minimal content library. Additionally, the analyst estimates AMC National Network advertising will decline by 6% in 2018, 3% in 2019 and 2% in 2020. Viewership for the AMC Channel's new originals have been "uninspiring," continuing recent trends, he contended, adding that although several of these new shows have received critical acclaim, viewership has not followed. Overall, the analyst argued that he would become more positive on AMC if the ratings declines reversed and it developed a meaningful new company-owned hit series. While co-production or licensing deals can be helpful in ramping up original content with less cost than full production, the more reduced participation in a show's ancillary revenue streams can hinder the ability of a company to fully take advantage of a hit, he noted. PRICE ACTION: In morning trading, shares of AMC Networks have dropped almost 3% to $65.48.
NWLI

Hot Stocks

10:29 EDT National Western Life Group agrees to acquire Ozark National in $203M deal - Ross Moody, chairman, president, and CEO of National Western Life Group, announced that its wholly owned subsidiary, National Western Life Insurance Company, has entered into a Stock Purchase Agreement to acquire Ozark National Life Insurance Company and N.I.S. Financial Services. The transaction is expected to close during the first quarter of 2019, subject to customary closing conditions, including regulatory approval. Ozark National and N.I.S., both based in Kansas City, Missouri, are wholly owned subsidiaries of CNS Corporation. Founded in 1964, Ozark National does business in thirty states and has life insurance inforce of over $6B. N.I.S. is an affiliated broker-dealer of Ozark National. Under the terms of the Stock Purchase Agreement, NWLIC will pay CNS Corporation cash in an aggregate amount of approximately $203M, subject to certain adjustments, in exchange for all of the outstanding stock of Ozark National and N.I.S. Financial Services, Inc.
ACST

Hot Stocks

10:15 EDT Acasti Pharma trading resumes
SNAP FB

Hot Stocks

10:13 EDT Snap slides after analysts cut price targets on decelerating user trends - Shares of Snap (SNAP) are falling after two analysts cut their price targets for shares to $7 citing decelerating user trends. DECELERATING TRENDS: On Thursday, Evercore ISI analyst Anthony DiClemente lowered his price target for Snap to $7 from $9 given decelerating trends, management turnover, and competitive threats. The analyst told investors in a research note that he anticipates another quarter of sequential daily average user declines as competitive pressures in the wake of Snap's app redesign, along with the seasonally weak third quarter, drive DAUs lower by 1M quarter over quarter. Further, DiClemente believes that competition, particularly from Facebook's (FB) Instagram is "irreversibly" reducing Snap's opportunity to deliver on long-term investor expectations. The analyst added that revenue estimates for Q3 do not seem "overly demanding," however the stock is trading at the "loftiest" valuation in his coverage and it's difficult to argue that investors would forgive a continuation of declining user trends. He also notes that there is no evidence to suggest that Snapchat is significantly expanding the pool of advertisers beyond its current base. DiClemente said given the lack of positive catalysts in the face of declining users, decelerating revenue growth and management turnover ahead of seasonally critical Q4, he is lowering his price target. He reiterated an Underperform rating on Snap's shares. MAINTAINING SELL: Despite the 44% decline in shares year-to-date, Citi analyst Mark May kept a Sell rating on Snap, but again lowered his estimates to reflect recent trends in user and average revenue per user growth, Q3 guidance and a projected 2018 exit growth rate. This results in May cutting his price target for the shares to $7 from $8. In support of his Sell rating, May cited the company's recent executive departures, user trends in Q2 and continued operating losses. Further, May told investors in a research note of his own that he believes consensus 2019 revenue forecasts still appear too high and that Snap could be forced to raise additional capital in 2019 or 2020 without meaningful changes in revenue growth and/or operating leverage. He pointed out that despite the recent share price declines, short interest in the name has continued to rise and that Snap "still trades at a premium to most comps." WHAT'S NOTABLE: In a September 10 SEC filing, Snap said its chief strategy officer Imran Khan would depart the company to pursue other opportunities. Khan will continue to serve as chief strategy officer for an interim period to assist with an effective transition of his duties and responsibilities, Snap said, adding that Khan's last day has "not been determined." PRICE ACTION: Snap dropped 6.5% to $7.69 in morning trading.
MFC

Hot Stocks

10:10 EDT Muddy Waters announces new short position in Manulife Financial - Muddy Waters announced a new short position in Manulife Financial. In a new report posted on its website, the short-selling firm said, "Muddy Waters is short Manulife Financial Corporation because we believe its securities do not price in the significant risk posed by the Mosten Trial. Trials are always hard to handicap; however, we believe there is a reasonable chance that Mosten prevails." The stock in morning trading is down 1%, or 21c, to $17.83. Reference Link
MFC

Hot Stocks

10:05 EDT Manulife Financial named new short idea by Muddy Waters
NXTTF

Hot Stocks

10:02 EDT Citron issues second short report on Namaste, sees ' blatant' fraud - In its second short reported published on Namaste Technologies (NXTTF), Citron Research says rarely has it seen a "fraud so blatant." Citron explained, "We honestly view Sean Dollinger as a walking securities violation. If Namaste was a US traded company it would be halted and Dollinger would probably face criminal charges." Shares of Namaste are down 3c to $1.78 in morning trading. Reference Link
GD

Hot Stocks

10:01 EDT General Dynamics awarded $465M contract from U.S. Army - General Dynamics was awarded a contract for the U.S. Army Life Cycle Product Line Management Program from the U.S. Army Contracting Command in Orlando, Florida. The five-year indefinite delivery, indefinite quantity contract is a hybrid, cost-plus fixed fee, firm fixed price, and time and material award worth $465M.
HMNY

Hot Stocks

10:00 EDT Helios and Matheson says Canaccord terminates equity distribution agreement - In a regulatory filing, Helios and Matheson Analytics said that on October 1, the company received a notice from Canaccord Genuity LLC terminating the equity distribution agreement between the company and Canaccord, dated April 18, effective as of October 11. The Equity Distribution Agreement permitted the company to offer and sell in an at-the-market offering shares of the company's common stock having an aggregate offering price of up to $150M from time to time through Canaccord. As of September 30, the company had sold shares of the company's common stock having an aggregate offering price of approximately $126M through Canaccord pursuant to the Equity Distribution Agreement. As a result of the termination of the Equity Distribution Agreement, no further offers or sales of the company's common stock will be made pursuant to the company's at-the-market offering.
RIGL

Hot Stocks

09:57 EDT Rigel estimates 891 bottles of Tavalisse shipped in nine months end Sept. 30 - In a regulatory filing earlier ahead of the company's investor and analyst event, Rigel Pharmaceuticals disclosed that it intends to announce that, based upon its preliminary estimates, Rigel shipped 649 and 891 bottles of Tavalisse to specialty distributors during the three and nine months ended September 30, 2018, respectively. "This estimate has been prepared by and is the responsibility of Rigel's management. Rigel has not yet completed its closing process for the quarter ended September 30, 2018. This information is preliminary, has not been audited and is subject to change upon completion of Rigel's closing procedures," the filing noted.
NXTTF

Hot Stocks

09:53 EDT Citon issues second short report on Namaste, sees ' blatant' fraud - In its second short reported published on Namaste Technologies (NXTTF), Citron Research says rarely has it seen a "fraud so blatant." Citron explained, "We honestly view Sean Dollinger as a walking securities violation. If Namaste was a US traded company it would be halted and Dollinger would probably face criminal charges." Shares of Namaste are down 3c to $1.78 in morning trading. Reference Link
MNR

Hot Stocks

09:47 EDT Monmouth Real Estate falls -7.4% - Monmouth Real Estate is down -7.4%, or -$1.20 to $14.98.
NVO

Hot Stocks

09:47 EDT Novo Nordisk falls -7.4% - Novo Nordisk is down -7.4%, or -$3.46 to $43.23.
RTEC

Hot Stocks

09:47 EDT Rudolph Technologies falls -14.6% - Rudolph Technologies is down -14.6%, or -$3.51 to $20.45.
STZ

Hot Stocks

09:47 EDT Constellation Brands rises 6.1% - Constellation Brands is up 6.1%, or $12.82 to $223.58.
CLDR

Hot Stocks

09:47 EDT Cloudera rises 13.1% - Cloudera is up 13.1%, or $2.24 to $19.32.
BKS

Hot Stocks

09:47 EDT Barnes & Noble rises 26.5% - Barnes & Noble is up 26.5%, or $1.45 to $6.91.
VZ

Hot Stocks

09:40 EDT Gregory Wasson resigns from Verizon board after SEC settlement - Verizon Communications disclosed this morning that on October 1, Gregory Wasson informed the company that he is resigning from the board, effective October 1. Wasson's decision to resign is not the result of any disagreement with the company, Verizon added. Wasson, the former CEO of Walgreens Boots Alliance (WBA), agreed last week to pay $160,000 to settle claims by the SEC that the company's management failed to adequately disclose risks regarding its ability to reach earnings goals.
PNC

Hot Stocks

09:38 EDT Gregory Wasson resigns from PNC board after SEC settlement - PNC Financial (PNC) disclosed this morning that on October 1, Gregory Wasson provided notice of his resignation from the company's board of directors, effective immediately. Wasson's decision to resign is not the result of any disagreement with PNC. the company added. Wasson, the former CEO of Walgreens Boots Alliance (WBA), agreed last week to pay $160,000 to settle claims by the SEC that the company's management failed to adequately disclose risks regarding its ability to reach earnings goals.
MATW

Hot Stocks

09:37 EDT Matthews mentioned cautiously by Grant's Interest Rate Observer
ACST

Hot Stocks

09:35 EDT Acasti Pharma trading halted, news pending
STRO

Hot Stocks

09:32 EDT Citadel reports 7.7% passive stake in Sutro Biopharma - Citadel Advisors disclosed a 7.7% stake in Sutro Biopharma, which represents over 1.7M shares. The filing with the SEC does not allow for activism.
ENSG

Hot Stocks

09:30 EDT Ensign Group acquires Nevada senior housing facility - Ensign Group, the parent company of the Ensign group of skilled nursing, rehabilitative care services, home health care, hospice care and assisted living companies, announced that Bridgestone Living, Ensign's assisted and independent living portfolio company, acquired the real estate and operations of Villa Court Assisted Living and Memory Care, a 53-unit assisted living and 20-unit memory care facility located in Las Vegas, Nevada. This acquisition brings Ensign's growing portfolio to 186 skilled nursing operations, 22 of which also include assisted living operations, 52 assisted and independent living operations, 21 hospice agencies, 22 home health agencies and six home care businesses across sixteen states.
BCLI

Hot Stocks

09:28 EDT BrainStorm announces results from NurOwn Phase 2 trial - BrainStorm announced that their scientific abstract received the clinical abstract award at this year's Annual Northeast Amyotrophic Lateral Sclerosis, or NEALS, conference. To relate CSF miRNA changes to CSF biomarkers of apoptosis and innate immune activation in pre- and 2-weeks post-intrathecal transplantation of MSC-NTF cells in a NurOwn Phase 2 trial. The biomarker data demonstrated increases in miRNA 132 and miRNA 146a and statistically significant decreases in MCP-1, SDF-1, CHIT-1 and Caspase-3 levels in CSF following a single MSC-NTF cell transplantation in the NurOwn Phase 2 trial. The data presented suggests that miRNA secreted by MSC-NTF cells may contribute to CSF biomarker evidence of neuroprotection and immunomodulation. Additional miRNA evaluation and biomarker correlations will be examined in the ongoing NurOwn Phase 3 pivotal trial in ALS.
CDLX LYG

Hot Stocks

09:26 EDT Cardlytics announces multiyear contract renewal with Lloyds Bank - Cardlytics (CDLX) announced a multi-year contract renewal with Lloyds Bank (LYG). On September 28, 2018, Cardlytics UK Limited, a wholly owned subsidiary of Cardlytics, Inc., renewed its Spending Rewards Agreement with Lloyds Bank Plc. Under the agreement, Cardlytics UK Limited will continue to provide Cardlytics Direct to Lloyds customers through December 31, 2020.
CTHR AMZN

Hot Stocks

09:23 EDT Charles & Colvard announces jewelry availability on Amazon in Europe - Charles & Colvard (CTHR) announced the availability of Charles & Colvard moissanite jewelry on Amazon (AMZN) marketplaces in European countries, including Spain, Italy, France and Germany. The launch of these four marketplaces is part of the company's strategic initiative to target the global market opportunity through focused channel expansion and continued brand building. This European marketplace expansion builds on the company's success in driving online sales growth. In Q2, Charles & Colvard net sales from marketplaces increased 182%, led by 225% growth through Amazon, over the year-ago quarter.
BB

Hot Stocks

09:23 EDT BlackBerry and Virginia Tech partnering to train engineers on QNX technology - BlackBerry and Virginia Tech are partnering to educate mechanical engineers on BlackBerry QNX technology, a software for connected and autonomous cars. BlackBerry will help advance the Department of Mechanical Engineering's connected and autonomous vehicle research and provide hands-on training with BlackBerry QNX software. Additionally, BlackBerry has provided its QNX technology for use in Virginia Tech's autonomous vehicle concept cars which are competing in the international AutoDrive Challenge under the Team Victor Tango banner.
SMCI...

Hot Stocks

09:22 EDT Super Micro Computer sinks after report of Chinese hardware attack - Shares of Super Micro Computer (SMCI) are plunging in pre-market trading after the company was mentioned as being implicated in a Chinese scheme to spy on American companies, including giants such as Amazon (AMZN) and Apple (AAPL). BLOOMBERG REPORT: A U.S. government probe, which still remains open, found that tiny microchips hidden on servers' motherboards allowed attackers to create a stealth doorway into any network that included the altered machines, Bloomberg reported. The investigators found that the chips had been inserted at factories run by manufacturing subcontractors in China, according to Bloomberg, citing multiple people familiar with the matter. The chips were first discovered in servers assembled for Elemental Technologies by Super Micro Computer Inc. (SMCI), the report noted. In a statement issued by the company following Bloomberg's report, Supermicro said in part: "While we would cooperate with any government investigation, we are not aware of any investigation regarding this topic nor have we been contacted by any government agency in this regard. We are not aware of any customer dropping Supermicro as a supplier for this type of issue...Furthermore, Supermicro doesn't design or manufacture networking chips or the associated firmware and we, as well as other leading server/storage companies, procure them from the same leading networking companies." PRICE ACTION: In pre-market trading, Super Micro Computers shares have fallen $4.39, or 20.5%, to $17.01 per share. Reference Link
CAR

Hot Stocks

09:18 EDT Avis Budget announces mobility partnership with Brightline - Avis Budget announced a mobility partnership with Brightline. Under the agreement, Avis Budget will expand its footprint in Florida to offer Brightline passengers and those living or working near Brightline's three current stations with convenient access to Avis and Zipcar vehicles. As part of the collaboration, Avis will be integrated into the Brightline mobile app and on Brightline's online booking channel for convenient, one-stop shopping. Alternatively, travelers can reserve vehicles on the Avis or Zipcar mobile apps. Avis facilities are temporarily located at Brightline ticket counters at each of Brightline's three south Florida stations and will be moving to their permanent locations, adjacent to each station, by the end of the year.
MBI AGO

Hot Stocks

09:17 EDT National commences legal action seeking to lift PROMESA litigation stay - National Public Finance Guarantee Corporation, an indirect subsidiary of MBIA (MBI) announced that National, Assured Guaranty (AGO), Assured Guaranty Municipal Corp., and Syncora Guarantee have filed a motion in the U.S. District Court for the District of Puerto Rico to lift the PROMESA litigation stay that will allow the Creditor Group to seek to enforce its right to compel the appointment of an independent receiver for the Puerto Rico Electric Power Authority. The Creditor Group filed a similar motion in July 2017 that was denied by the District Court. The new motion follows a successful appeal of that denial, as the First Circuit Court of Appeals recently vacated the District Court's decision and remanded the case for further proceedings. The appointment of a receiver, which would assume operational control of PREPA to protect the interests of PREPA's customers and creditors, is necessitated by the utility's well-documented history of mismanagement and undue political interference in its operations, the combined results of which were laid bare by Hurricanes Irma and Maria. Bondholders holding at least 25 percent in principal amount of the PREPA bonds outstanding have a statutory right to the appointment of a receiver following an event of default. The Creditor Group represents approximately 27 percent of the outstanding bonds.
RMGN

Hot Stocks

09:16 EDT Virgo Capital, Sachs Capital Group acquire RMG Networks - RMG Networks announced that it has been converted to a privately held entity in a transaction led by Virgo Capital with participation from existing investor Gregory H. Sachs. The transaction included a large capital infusion to be used towards growth and acquisitions.
ADMS

Hot Stocks

09:14 EDT Adamas Pharmaceuticals publishes Phase 3 Gocovri data - Adamas Pharmaceuticals announced that pooled Phase 3 data of Gocovri extended release capsules were published online in Parkinsonism and Related Disorders. Results from pooled Phase 3 ADS-5102 clinical trials, concluded that dyskinesias in people with Parkinson's disease can impact a patient's activities of daily living, or ADLs, across multiple tasks and that treatment with Gocovri can help ameliorate the impairment. Gocovri is the first and only medicine approved by the FDA for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only drug approved by the FDA to treat dyskinesia in people with Parkinson's disease on levodopa therapy, as well as demonstrate a secondary benefit in reducing off time in that population. In the pooled Phase 3 analysis, most adverse reactions were of mild to moderate intensity, and the most common adverse reactions were hallucination, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension.
AVAV

Hot Stocks

09:13 EDT AeroVironment awarded $13M IDIQ contract by U.S. Air Force - AeroVironment announced the United States Air Force awarded the company a $13M indefinite delivery/indefinite quantity, or ID/IQ, contract on Sept. 30, 2018 for RQ-11B Raven small unmanned aircraft systems, or UAS, to support Latin American and Caribbean nations. United States Government fiscal 2018 operations and maintenance funds of $2.8M were committed at the time of the award. The work is expected to be completed by Sept. 28, 2023.
GE WMT

Hot Stocks

09:13 EDT GE Lighting converts Walmart shoppers to LED - GE Lighting (GE) has helped pave the way to shave 1.2 billion kWh of electricity use in consumer homes by converting Walmart (WMT) shoppers from traditional light bulbs to energy-efficient LEDs over the last two years. Not only has this shift supported Walmart's Project Gigaton, a Walmart supplier initiative aimed at reducing greenhouse gas emissions by one gigaton by 2030, the shift is also leaving a measured impact on consumer's energy expenses. LEDs use 70 to 90 percent less energy than traditional lighting options and last 15 to 25 times longer. GE Lighting encourages consumers to use October, Energy Action Month, as motivation to make the switch. To help, GE offers more than 100 energy-saving LED products at Walmart, including 36 ENERGY STAR LEDs, all $2 to $4 bulbs; ensuring consumers can make the switch to an ultra-efficient LED at every-day low prices.
EPD

Hot Stocks

09:11 EDT Enterprise Products raises quarterly distribution to 43.25c per sahre - Enterprise Products Partners announced that the board of its general partner declared an increase in the quarterly cash distribution paid to limited partners with respect to the third quarter of 2018 to 43.25c per common unit, or $1.73 per unit on an annualized basis. The quarterly distribution will be paid Thursday, November 8, 2018, to unitholders of record as of the close of business Wednesday, October 31, 2018.
STZ.B...

Hot Stocks

09:10 EDT Fly Intel: Pre-market Movers - HIGHER: Hortonworks (HDP) and Cloudera (CLDR), up 16% each after announcing a merger of equals... Barnes & Nobles (BKS), up 21% after after announcing a formal strategic review process... Eli Lilly (LLY), up 3% after potential type 1 diabetes treatment meets primary endpoint in a trial... Sarepta (SRPT), up 3% after gene therapy showed functional improvements across all measures. UP AFTER EARNINGS: Constellation Brands (STZ), up 4%. Canopy Growth (CGC), in which Constellation holds a stake, is also up 1%. DOWN AFTER EARNINGS: Pier 1 Imports (PIR), down 9%... Synnex (SNX), down 2%. ALSO LOWER: Select Income REIT (SIR), down 3% after a 24.918M share spot secondary priced at $18.25 per share... Tilray (TLRY), down 6% after providing Q3 guidance and announcing a $400M offering of convertible senior notes... Monmouth Real Estate (MNR), down 8.5% after its 8M share spot secondary offering priced at $15.00 per share.
CPB

Hot Stocks

09:10 EDT Campbell Soup urges shareholders to vote in support of current board directors - The letter, read in part, "The future of Campbell is bright. On August 30th, Campbell announced a series of significant actions stemming from our comprehensive Board-led strategy and portfolio review, which are directly aimed at turning around the business, improving operating and financial performance and returning Campbell to sustainable profitable growth. As part of this review, the Board considered a full slate of strategic options to maximize shareholder value, including optimizing the portfolio, divesting businesses, splitting the Company, and pursuing a sale. All options were on the table....Unfortunately, Third Point, a New York-based hedge fund that only recently became a Campbell shareholder and held material short positions in Campbell stock for most of 2017, is attempting to deprive shareholders of the future value potential of Campbell by forcing a sale of your Company while we are executing on our strategic plan to create value. The Campbell Board strongly objects to Third Point's aggressive and short-sighted tactics and urges shareholders to reject the hedge fund's misguided efforts and "one-point" agenda for Campbell...After considerable analysis and evaluation, the Board concluded that the best path forward to maximize shareholder value at this time is to: Focus Campbell on two distinct businesses, Campbell Snacks and Campbell Meals and Beverages, in our core North American market; Pursue the divestitures of two non-core businesses - Campbell International and Campbell Fresh - to focus and improve our portfolio. We intend to use the proceeds to significantly reduce debt and improve the balance sheet; and, increase our cost savings target by $150M, which will bring our total cost savings efforts to $945M by the end of fiscal year 2022, including the expected Snyder's-Lance savings...To help sharpen our focus, we are pursuing the sale of the Campbell International business, which includes Arnott's and the Kelsen Group, and our Campbell Fresh business, which includes Bolthouse Farms, Garden Fresh Gourmet and the refrigerated soup business. These are great brands and solid businesses, but they do not fit with Campbell's new strategic direction. We believe they will be of greater value to new owners who are focused on these categories and geographies. The proposed divestitures represented approximately $2.1B in net sales in fiscal year 2018. We have engaged leading financial advisers and have initiated a disciplined process aimed at achieving maximum value. We intend to use the proceeds from these divestitures to significantly reduce debt and are targeting a pro forma EBITDA leverage ratio of 3.0x by the end of 2021...Campbell's Board and management team are aligned and working with urgency to improve performance and revitalize the Company to be focused on our franchise businesses to drive sustainable, profitable growth...Over the next several weeks, you will receive additional outreach from Campbell. You also are likely to receive outreach from Third Point. We urge you to NOT vote using any WHITE proxy card or voting instruction forms you might receive from Third Point. Please disregard and discard the WHITE proxy card."
MNKD

Hot Stocks

09:08 EDT MannKind presents Afrezza STAT study data at EASD - MannKind presented data from the STAT study at the 54th Annual Meeting of the European Association for the Study of Diabetes, or EASD. The STAT study is the first randomized, controlled study to assess diabetes control using continuous glucose monitoring, or CGM, and Afrezza in individuals with type 1 diabetes. The dual primary endpoints were an assessment of glucose time-in-range as well as post-prandial glucose excursions in the 1-4 hour post-meal period.
VNRX

Hot Stocks

09:08 EDT VolitionRx expanding its Nu.Q trials to veterinary diagnostics - VolitionRx announced "very encouraging" preliminary results from a proof of concept study using its Nu.Q diagnostic test in veterinary medicine that demonstrated that nucleosomes can be detected in dogs and, therefore, the potential to differentiate cancer from other conditions. Volition will now test its Nu.Q platform in larger trials in veterinary medicine. Volition intends to do as much of this clinical trial work as possible through external collaborations thereby maintaining its internal focus on clinical research for human diseases. Volition has engaged a consultant in the U.S. to define the business strategy and foster key relationships necessary to launch the commercialization process. Volition plans to determine the performance of Nu.Q assays in larger trials in the most prevalent forms of canine malignancies.
ICFI

Hot Stocks

09:07 EDT ICF International acquires We are Vista, terms not disclosed - ICF announced that it has acquired We are Vista, a leading U.K.-based creative communications agency working to support the growth of global brands in the U.K., Europe and beyond. We are Vista will become a part of ICF's full marketing and communication team, which offer unique, broad expertise across the entire spectrum of marketing services, including strategic communications, advertising, digital engagement, public relations, loyalty, customer relationship management and brand management.
OSTK

Hot Stocks

09:06 EDT Overstock.com subsidiary Medici Ventures invests in VinX - Medici Ventures, the blockchain accelerator and subsidiary of Overstock.com announces its latest strategic investment in VinX, an Israel-based company developing a blockchain platform to streamline wine futures trading while reducing fraud through secure supply-chain tracking from product provenance. VinX plans to create a token-based digital wine futures platform based on the Bordeaux futures model that allows for the selling and trading of wine futures on a transparent and secure blockchain to create an even playing field for transactions on a global scale. VinX's platform aims to reduce fraud in the wine industry by using the secure and immutable aspects of blockchain to track provenance of wine to end consumer at a cost bearable to the industry.
HALO

Hot Stocks

09:05 EDT Halozyme's PEGPH20 data featured in Clinical Cancer Research publication - Halozyme announced the publication of nonclinical data for PEGPH20 in Clinical Cancer Research, an American Association for Cancer Research journal. PEGPH20 is the PEGylated version of Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20. The paper demonstrates an association with increased collagen content, high tumor interstitial pressure, vascular collapse, hypoxia, drug resistance and increased metastatic potential. Treatment with PEGPH20 at the human equivalent dose degraded HA in the TME reversing these changes, and also depleted an important proangiogenic growth factor, VEGF-A165, suggesting that treatment with PEGPH20 may diminish the angiogenic potential of the TME. The accumulation of HA is common in many cancers, particularly in pancreatic cancer. A Phase 3 study evaluating the ability of PEGPH20 plus Abraxane and gemcitabine to increase Progression Free Survival and Overall Survival versus Abraxane and gemcitabine alone in metastatic pancreatic ductal adenocarcinoma patients, is under way.
OCN PHH

Hot Stocks

09:04 EDT Ocwen completes acquisition of PHH; Glen Messina becomes president and CEO - Ocwen Financial Corporation (OCN) announced the completion of its acquisition of PHH Corporation (PHH), a mortgage platform with established servicing and origination recapture capabilities, effective October 4, 2018 for approximately $360M in cash or $11 per diluted common share. As previously announced, concurrent with the closing of the PHH merger, Glen A. Messina became the President and CEO of Ocwen and a member of Ocwen's Board of Directors. In connection with the completion of the acquisition, PHH has become a wholly-owned subsidiary of Ocwen and the common stock of PHH has been delisted from the New York Stock Exchange.
CPB

Hot Stocks

09:04 EDT Campbell Soup sends letter to shareholders detailing actions to maximize value - Campbell Soup Company announced it has filed definitive proxy materials, including its definitive proxy statement and GOLD proxy card, with the U.S. Securities and Exchange Commission in connection with Campbell's 2018 Annual Meeting of Shareholders, scheduled for Nov. 29, 2018. Campbell shareholders of record as of the close of business on Oct. 9, 2018 will be entitled to vote at the Annual Meeting. The company said, "In addition to filing these proxy materials, Campbell sent a letter to its shareholders. In the letter, Campbell: Summarizes the results of its comprehensive Board-led strategy and portfolio review and the significant actions that are underway to focus Campbell's portfolio, improve performance and maximize shareholder value; Highlights the strength and experience of its directors and why it has the right Board to lead Campbell going forward; Highlights the strength of its new management team; and Discusses why Third Point's actions are not in shareholders' best interests and its proposed nominees lack the required skills and expertise to oversee a public company like Campbell and its iconic brands. Campbell strongly recommends that shareholders vote to support the current Campbell Board of Directors with a vote on the GOLD proxy card. In conjunction with the definitive proxy filing, Campbell the following letter to shareholders and launched www.CampbellsStrategy.com. These materials will be available at www.sec.gov. The website will be updated as additional information becomes available."
AMD

Hot Stocks

09:03 EDT Moody's upgrades AMD corporate family rating to Ba3 - Moody's Investors Service announced yesterday that it upgraded Advanced Micro Devices' corporate family rating to Ba3, senior unsecured rating to B1, and affirmed the speculative grade liquidity rating of SGL-1. The outlook is stable. "The upgrade of the corporate family rating to Ba3 reflects AMD's improved performance outlook, driven by design wins, modest market share gains, and an expanded set of product offerings. As a result, Moody's expects around 25% revenue growth in 2018 and at least high-single digit revenue growth, slightly higher gross margins, as well as operating profitability and positive free cash flow in 2019. For 2018, Moody's projects revenue over $6.5B, free cash flow over $200M, and adjusted gross debt to EBITDA of about 2.5x with leverage declining below 2.0x in 2019," Moody's stated.
MSFT

Hot Stocks

09:01 EDT Microsoft, Redline Communications announce partnership - Redline Communications and Microsoft announced a new partnership that will help address the rural broadband gap using TV White Space technology. Redline, a leader in private wireless networks, will provide its Virtual Fibera radio technology in the TV White Space band to Microsoft Airband Initiative partners. Together, Redline and Microsoft's partnership will help make broadband internet more affordable and accessible to unserved and underserved customers in rural areas in the United States and globally.
PHH

Hot Stocks

08:51 EDT PHH Corp. trading halted, news dissemination
TMDI

Hot Stocks

08:48 EDT Titan Medical achieves Q3 milestones for SPORT Surgical System - Titan Medical announced that the company has achieved all of its publicly stated Q3 development milestones for the SPORT Surgical System. It completed the improved camera insertion tube engineering confidence build. Titan Medical also completed design enhancements of both the surgeon workstation and patient cart in anticipation of system engineering confidence build by year-end. The company completed and demonstrated full suite of simulation training software for beta testing and filed three Q-submissions containing detailed protocols for animal, cadaver and human confirmatory studies for review by the FDA, approximately one year ahead of plan.
MDU

Hot Stocks

08:48 EDT MDU Resources acquires Sweetman Const. Co., terms not disclosed - MDU Resources announced it has acquired Sweetman Const. Co., a premier provider of aggregates, asphalt and ready-mix concrete in the Sioux Falls, South Dakota, market. Sweetman, which does business as Concrete Materials Company, will become part of Knife River Corporation, the construction materials subsidiary of MDU Resources. Financial details of the acquisition were not disclosed. MDU Resources anticipates the acquisition will be accretive to earnings per share. Sweetman's team of 260 employees will join Knife River's North Central Region, which operates in Iowa, Minnesota, Nebraska, North Dakota and South Dakota.
FLDM

Hot Stocks

08:46 EDT Fluidigm enters into non-exclusive distribution agreement with DNA Software - Fluidigm announced that it has entered into a non-exclusive distribution agreement with DNA Software to provide CopyCount-CNV software for use with the Fluidigm Biomark HD system. Copy number variation, or CNV, plays a role in a number of complex human diseases and in drug metabolism. It occurs when the number of copies of a given gene or genomic region varies between individuals within a population. Biomark HD utilizes microfluidics technology to detect CNVs, with significant cost and time savings over traditional plate-based methods.
ATIS

Hot Stocks

08:42 EDT Attis Industries receives 180 day extension to comply with Nasdaq - Attis Industries announced that Nasdaq has granted the company a 180-day extension to comply with Nasdaq's minimum bid price requirement.
MSG

Hot Stocks

08:41 EDT Madison Square Garden files form 10 with SEC for potential spin-off - Madison Square Garden announced that it has made important progress towards the potential spin-off of its sports business by filing a confidential initial form 10 registration statement with the SEC. The proposed separation of the sports and entertainment businesses would enable investors to more clearly evaluate each company's assets and future potential, while providing both companies with increased strategic flexibility to pursue their own distinctive business plan and capital allocation policy. The proposed separation would be structured as a tax-free spin-off to all MSG shareholders. Upon completion of the transaction, record holders of MSG common stock would receive a pro-rata distribution, expected to be equivalent, in aggregate, to an approximately two-thirds economic interest in the pure-play sports company. The remaining common stock would be retained by the live entertainment company and is expected to be used to raise capital and/or exchange for the common stock of the entertainment company. The Dolan family would maintain majority voting control of both companies through their ownership of Class B shares. The proposed transaction is currently expected to be completed during the first half of calendar 2019, subject to certain conditions.
AMPE

Hot Stocks

08:39 EDT Ampio provides update on BLA for Ampion - Ampio provided an update of ongoing activities required to file a Biologics License Application for Ampion for the treatment of severe Osteoarthritis of the knee. The company is currently focused on completing the following regulatory requirements established by the FDA: perform two pivotal clinical trials of Ampion that demonstrate the safety and efficacy of Ampion; all Ampion clinical studies must provide evidence in support of a BLA; FDA must accept the Chemical and Manufacturing Controls program for the investigational product. The AP-003-C OLE study was designed to support the safety and tolerability of repeat injections of Ampion over the course of at least one year. No serious drug-related adverse events have been reported, and all patients demonstrated a sustained reduction in pain over the course of the trial. On September 27, OTAT provided a favorable response, with no areas of dispute, in support of CMC for the Ampion BLA. The company is continuing discussions with the FDA to determine if the pivotal AP-003-C study is the final trial required to support the Ampion BLA. Should another trial be required, the company will move quickly to meet the FDA requirements under a Special Protocol Assessment. The company believes that Ampion will be identified as a "reference product" upon FDA approval of their BLA, granted twelve years of exclusivity.
IFMK

Hot Stocks

08:38 EDT iFresh to accept UnionPay - iFresh announced that UnionPay will be accepted iFresh stores across the United States. UnionPay cardholders will be able to pay with their smartphones at point-of-sale via the UnionPay mobile application. iFresh will provide UnionPay services online and in stores across the U.S. facilitated through a partnership with CITCON, a leading cross-border mobile payments and marketing solutions provider that helps connect merchants with Chinese mobile wallet users.
MANH

Hot Stocks

08:36 EDT Brooks Brothers selects Manhattan Associates to improve customer experience - Brooks Brothers selected Manhattan Associates to improve contact center operations and deliver a seamless omnichannel shopping experience for customers worldwide. New York-based Brooks Brothers is deploying Manhattan Active Omni to fuel its customer experience platform across its full network of 300 retail locations. Brooks Brothers selected Manhattan Active Omni, which marries order management and store fulfillment applications on a single platform, to deliver superior product fulfillment across all channels.
HTZ

Hot Stocks

08:36 EDT Hertz names Tracy Gehlan as COO for Hertz International - Hertz Global Holdings announced that Tracy Gehlan has joined the company as COO for Hertz International. Reporting to Michel Taride, Group President, Hertz International, Gehlan is based at the car rental company's International headquarters near London, UK.
TEUM

Hot Stocks

08:35 EDT Pareteum promotes Denis McCarthy to President - Pareteum has promoted Denis McCarthy as the company's first president, and Amy Love has joined as Chief Marketing Officer. Formerly senior VP of corporate development, McCarthy was previously senior VP of finance and operations at Mosaic Networx, which delivers cloud-based data and telephony services to enterprises. Love joins Pareteum from the Georgia Institute of Technology Advanced Technology Development Center where she led statewide programs, helping technology startups launch and scale.
GCAP

Hot Stocks

08:35 EDT GAIN Capital reports September operating metrics - In the retail segment in September, OTC Trading Volume was down 14.3% sequentially and down 26.2% y/y. OTC Average Daily Volume was down 1.3% sequentially and down 21.9% y/y. 12 Month Trailing Active OTC Accounts were up 0.2% sequentially and were down 3.5% y/y. 3 Month Trailing Active OTC Accounts were down 2.1% sequentially and down 13% y/y.
SNMX

Hot Stocks

08:32 EDT Firmenich commences tender offer to acquire Senomyx for $1.50 per share - Firmenich announced that its wholly-owned U.S. subsidiary, Sentry Merger Sub, commenced the previously announced tender offer to acquire all of the outstanding common stock of Senomyx for $1.50 per share, net to the seller in cash, without any interest thereon and less any applicable withholding taxes. The tender offer is scheduled to expire at 12:00 midnight, New York City time, on November 2, 2018, unless extended in accordance with the merger agreement and the applicable rules and regulations of the U.S. SEC.
ANIP

Hot Stocks

08:32 EDT ANI Pharmaceuticals launches authorized generic of Atacand HCT tablets - ANI Pharmaceuticals launched Candesartan Hydrochlorothiazide Tablets, an authorized generic of Atacand HCT. The current annual U.S. market for this product is approximately $20M.
ASCMA

Hot Stocks

08:29 EDT Ascent Capital, Monitronics reject proposal from purported ad hoc group - Ascent Capital Group and its wholly owned subsidiary, Monitronics International, announced that Ascent and MONI yesterday received and rejected a counterproposal from an attorney purporting to represent certain unidentified holders of an undisclosed and unsubstantiated amount of MONI's approximately $1.1B term loan. MONI is currently soliciting consents from holders of the Term Loan to implement the second lien exchange offer contemplated in the previously disclosed transaction support agreement, dated September 24, 2018, among Ascent, MONI and holders of approximately 66% of MONI's 9.125% Senior Notes due 2020. As previously disclosed, if the requisite majority consents to amend the Term Loan are not received, Ascent and MONI will instead implement the unsecured exchange offer contemplated by the Support Agreement, which does not require any consents from holders of the Term Loan. The deadline for submitting consents to the Term Loan amendment remains 5:00 p.m., New York City time, on October 4, 2018. The terms of the Term Loan amendment have not been revised. Only Term Loan lenders who affirmatively consent to the amendment by the deadline will be eligible to receive the proposed 50 bps increase in interest rate spread and a share of the proposed $100M aggregate repayment.
ORMP

Hot Stocks

08:26 EDT Oramed enrolls first patient in clinical study for oral insulin in NASH - Oramed has enrolled the first patient in an exploratory clinical study of its oral insulin capsule, ORMD-0801, in the treatment of nonalcoholic steatohepatitis, or NASH. The three-month treatment study will assess the effectiveness of ORMD-0801 in reducing liver fat content, inflammation and fibrosis in patients with NASH. Data from preclinical studies and clinical studies of ORMD-0801 demonstrate Oramed's oral insulin capsule has the potential to reduce inflammation of the liver.
ALSK

Hot Stocks

08:19 EDT Alaska Communications shareholder 22NW Fund writes letter to board - Alaska Communications shareholder 22NW Fund, which owns about 2.2%, of ALSK shares, delivered a letter to the Alaska board of directors. The letter states, among other things: "As President of 22NW, I feel compelled to share my opinion regarding the lack of value creation illustrated by the inadequate performance of the stock over the past 3 1/2 years (...) ALSK has severely underperformed (...) I believe the right path is for the Board to retain an independent, nationally-recognized investment bank to evaluate strategic alternatives in order to maximize shareholder value. (...) the operational and financial gains have stalled since 2016 despite management committing significant funds toward "growth" capital (...) I believe the company has a competitive position that makes these flat results unacceptable. This management team has spent considerable "growth" capital and investors have not received a return on this investment (...) This capital could have been used to further de-lever the company's balance sheet (...) I believe this gross misallocation of capital is a key reason ALSK's stock price continues to trade at a depressed valuation. The board has overseen a slow bloodletting of shareholder value via generous compensation packages for management, and in particular to its CEO Anand Vadapalli. (...) The last time any director or executive made an open market purchase of Shares was in March 2013. (...) I believe there is only one-way forward for stockholders to realize meaningful value creation: the Board must immediately hire an independent, nationally-recognized investment bank to evaluate strategic alternatives. (...) The broader telecom industry is seeing significant consolidation. (...) I believe that if the Board explored a process to sell the Company, ALSK would have at least several suitors and the price to be paid would fall in the range of recent precedent transactions with an EV/EBITDA multiple of 5.5x - 6.5x for an equity value of about $2.62-$3.66 per share, or 59% - 123% upside. (...)
VAR

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08:16 EDT Varian Medical signs educational partnerships with Reliance Group in India - Varian announced it has signed an educational partnership with one of India's leading hospital groups to provide greater access to training in advanced radiotherapy and radiosurgery techniques. The Varian Advanced Clinical School will run courses at the Reliance Group's' Kokilaben Dhirubhai Ambani Hospital in Mumbai, where the region's first Varian Edge radiosurgery system was installed in 2016. In addition to the Clinical School, Varian and KDAH will be providing an advanced fellowship program for radiation therapy technologists, providing them with skills to implement high-end treatment modalities.
SALT

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08:14 EDT Scorpio Bulkers announces commitment for new loan facility - Scorpio Bulkers announced that it has received a commitment from Nordea Bank Abp, acting through its New York branch, and DVB Bank SE for a loan facility of up to $90M. The loan facility will be used to finance up to 60% of the fair market value of six Ultramax dry bulk vessels. The loan facility has a final maturity date of five years from signing date and bears interest at LIBOR plus a margin of 2.35% per annum. This loan facility, which is expected to close within October, would increase the company's liquidity by approximately $28M after repayment of the vessels' existing debt. The terms and conditions are similar to those set forth in the company's existing credit facilities and the loan facility is subject to customary conditions precedent and the execution of definitive documentation.
AMAG

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08:12 EDT Amag Pharmaceuticals to present data on Intrarosa at NAMS - Amag Pharmaceutical and Endoceutics announced an oral presentation regarding the effect of time since menopause, age, and previous hormone therapy on treatment efficacy of intravaginal 6.5 mg prasterone at the Annual Meeting of The North American Menopause Society, or NAMS. David Archer and colleagues analyzed combined data obtained from two prospective, randomized, double-blind, placebo-controlled clinical trials to evaluate the effect of daily intravaginal 6.5 mg Intrarosa administered for 12 weeks to women who identified moderate to severe pain at sexual activity as their most bothersome symptom, or MBS, of vulvar and vaginal atrophy, or VVA. The goal of the analysis was to assess the potential influence of time since menopause, age and previous hormone therapy on the response to treatment. Overall, there were 406 women treated with 6.5 mg Intrarosa and 234 women who received placebo. Women were divided into subgroups based upon time since menopause, age and if they had ever taken hormone therapy. While age and prior hormone therapy did not influence the overall efficacy of Intrarosa, the greatest reduction of dyspareunia had a tendency to be observed in women who were 1-2 years post menopause, compared to 3-5 years and more than 6 years post menopause, although the difference did not reach statistical significance.
AER

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08:10 EDT AerCap purchased, sold 87 aircraft in Q3 - AerCap Holdings has announced its major business transactions during Q3: Signed lease agreements for 62 aircraft, including 9 widebody aircraft and 53 narrowbody aircraft; Purchased 12 aircraft, including 6 Airbus A320neo Family aircraft, 2 Airbus A350s, 2 Boeing 737 MAX 8s and 2 Boeing 787-9s; Executed sale transactions for 13 aircraft, including 4 Airbus A320 Family aircraft, 2 Airbus A330s, 1 Airbus A340, 1 Boeing 737NG, 1 Boeing 757, 2 Boeing 767-300ERs, 1 Boeing 777-200ER and 1 Boeing 777-300; Signed financing transactions for $750 million.
GBT

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08:07 EDT Global Blood Therapeutics to present three SCD abstracts at SCDAA - Global Blood Therapeutics announced that three abstracts related to its sickle cell disease, or SCD, development programs, including voxelotor, have been accepted for oral presentation during the annual National Sickle Cell Disease Association of America, or SCDAA.
RGLS

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08:07 EDT Regulus announces 1-for-12 reverse stock split - Regulus announced that at the special meeting of stockholders, held September 28, 2018, stockholders voted to approve a proposal authorizing the Board of Directors of the Company to amend the Company's certificate of incorporation to effect a reverse stock split of Regulus' outstanding common shares. Following the special meeting of stockholders, the Board of Directors approved a 1-for-12 reverse stock split. The effective time of the reverse stock split was 5:00 p.m. ET on October 3, 2018. The Company's shares will begin trading on a split-adjusted basis commencing upon market open on October 4, 2018.
TDY

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08:07 EDT Teledyne awarded $7M IDIQ contract by NOAA - Teledyne Webb Research, a division of Teledyne Technologies, has received an indefinite delivery/indefinite quantity, or IDIQ, contract from the National Oceanic and Atmospheric Administration, or NOAA, for the provision of Slocum gliders, sensors, and service components. The award has a maximum value of $7M over five years, with an initial procurement in excess of $600,000. The U.S. Antarctic Marine Living Resources, or AMLR, Program of the NOAA Fisheries Service has conducted ship-based acoustic and oceanographic research surveys around the Antarctic Peninsula since 1986. Data collected from this Program are used to provide advice to the Convention for the Conservation of Antarctic Marine Living Resources, or CCAMLR, that establish catch limits for the Antarctic krill fishery. Climate changes have altered the distribution, intensity and timing of this important fishery over the last decade. The fishery season, for example, has expanded as both sea-ice extent and distribution have declined. This expansion leads to a potential negative impact on ecosystem health such as known areas of krill-dependent predators. In an effort to systematically provide ecological data at appropriate spatio-temporal scales, and over a longer sampling season, the U.S. AMLR Program has implemented a krill research program that will utilize an array of moorings and gliders around the Antarctic Peninsula. Data collected from this research will replace traditional ship-based surveys and will provide standardized spatial and temporal data to better understand the consequences of overlap among krill, predators, and the krill fishery, and provide other dynamic oceanic attributes of the study area. Along with arrays of moored ADCPs and CTDs, NOAA has developed a glider-based survey program. Teledyne Webb Research G3 electric Slocum gliders, equipped with Acoustic Zooplankton Fish Profilers, or AZFP, using three acoustic frequencies to record backscatter of krill biomass. This sampling Program will commence in October of 2018, and is expected to provide the framework for sustained ecosystem monitoring using autonomous platforms. This Indefinite Delivery Indefinite Quantity, or IDIQ, services contract will provide The U.S. AMLR Program with the ability to continue to build out its glider fleet, add additional science components and service the gliders.
TM...

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08:06 EDT Toyota, SoftBank agree to form JV for self-driving car services - Shares of Toyota (TM) are in focus on Thursday after the company announced plans to team up with SoftBank (SFTBF) to develop self-driving car services. The news follows an announcement from General Motors (GM) on Wednesday that Honda (HMC) will invest $2.75B and take a 5.7% stake in its Cruise self-driving vehicle unit, in which SoftBank is also an investor. TOYOTA, SOFTBANK TO FORM JV: Toyota announced in a statement that it and SoftBank will form a joint venture called MONET, short for mobility network, to develop businesses that will use driverless-car technology to offer new services, such as mobile convenience stores and delivery vehicles in which food is prepared en route. MONET will provide coordination between Toyota's Mobility Services Platform, Toyota's information infrastructure for connected vehicles, and SoftBank's Internet of Things Platform, which was built to create new value from the collection and analysis of data acquired from smartphones and sensor devices, the companies said. MONET will roll out an autonomous driving service using e-Palette, Toyota's dedicated battery electric vehicle for mobility services, by the second half of the 2020s, Toyota and SoftBank added. The venture will have initial capital of Y2B, and SoftBank will own just over half of the business, which will initially focus on Japan and eventually go global, according to a Reuters report. Junichi Miyakawa, chief technology officer at SoftBank who will be CEO of the new company, commented that "SoftBank alone and automakers alone can't do everything... We want to work to help people with limited access to transportation." WHAT'S NOTABLE: Earlier this year, Toyota set up a new company dedicated to the research and development of self-driving vehicles, with plans to invest $2.8 billion to develop a commercially viable autonomous car. RECENT PARTNERSHIPS IN AUTONOMOUS VEHICLES: On Wednesday, Cruise and GM announced that they partnered with Honda to work towards large-scale deployment of autonomous vehicle technology. Honda will work jointly with Cruise and General Motors to fund and develop a purpose-built autonomous vehicle for Cruise that can serve a wide variety of use cases and be manufactured at high volume for global deployment. Honda will contribute approximately $2B over 12 years to these initiatives, which, together with a $750M equity investment in Cruise, brings its total commitment to the project to $2.75B. SoftBank's Vision Fund committed $2.3B to Cruise earlier this year. Additionally, Renault (RNSDF)-Nissan (NSANY) and Daimler (DDAIF) are considering expanding their collaboration to battery and autonomous vehicle technology as well as mobility services, Reuters reported on Wednesday, citing comments made by the CEOs of both companies. "The industry being in transformation in the area of connectivity, autonomous cars and connected services, there are plenty of areas of cooperation for our entities," Renault Nissan CEO Carlos Ghosn said.
TPX

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08:06 EDT Tempur Sealy finalizes agreement on Danish tax dispute - Tempur Sealy has executed an agreement between the Company, the U.S. Internal Revenue Service and the Danish Tax Authority with respect to income tax assessments from SKAT for the disputed tax years 2001 to 2011. As discussed in the Company's periodic reports filed with the U.S. Securities and Exchange Commission, the Company had received significant income tax assessments from SKAT for prior tax years that the Company had disputed. The tax assessments related to the appropriate royalty rate to be paid to the Company's Danish subsidiary for the right to utilize certain intangible assets owned by the Danish subsidiary. The resolution reached in the three-party agreement is consistent with the Company's tax liability disclosed in its previously filed financial statements, which is significantly less than the amounts originally assessed by SKAT. The settlement will not have a material impact on the Company's financial position or liquidity as the Company maintains funds equal to the estimated Danish tax liability on deposit with SKAT. The Company's go forward effective tax rate is not expected to be materially impacted by the agreement. The Company is in the process of entering into negotiations with the U.S. Internal Revenue Service and SKAT to reach a mutual agreement with respect to the appropriate royalty rates for years after 2011. The outcome of these discussions is not expected to have a material impact on the Company's results of operations, liquidity or financial position.
VXRT

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08:05 EDT Vaxart to present new data from Phase 2 Challenge study of oral H1 Flu vaccine - Vaxart announced it will present new data from the Phase 2 Challenge Study of its H1 influenza oral tablet vaccine at IDWeek 2018 in San Francisco on Saturday, October 6, 2018. "These latest results show that our vaccine elicited a significant expansion of mucosal homing receptor alpha4beta7+ plasmablasts to approximately 60% of all activated B cells, while Fluzone only maintained baseline levels of 20%. We believe these beta7+ plasmablasts are a key indicator of a protective mucosal immune response and a unique feature of our oral recombinant vaccines," said CSO Sean Tucker. "Further analysis of the data also confirm that, while our vaccine also generated protective hemagglutinin inhibition antibodies in serum like conventional injectable flu vaccines, it primarily protected through the mucosal mechanism, providing a robust 39% reduction in illness versus placebo overall. In contrast, Fluzone, the market-leading injectable quadrivalent influenza vaccine, only provided a 27% reduction in illness versus placebo, while protecting primarily through HAI antibodies." Vaxart previously reported only 37% of study participants receiving the Vaxart vaccine developed influenza infection after challenge, compared to 44% of those receiving Fluzone and 71% of those receiving placebo. The new Phase 2 data to be presented at IDWeek 2018 showed that the Vaxart vaccine generated a strong increase in mucosal homing antibody secreting cells, or beta7+ plasmablasts. In protected study participants, the percentage of beta7+ plasmablasts in recipients of the Vaxart vaccine nearly doubled, whereas the percentage of beta7+ plasmablasts in Fluzone recipients remained unchanged. The Phase 2 study was completed with support from Biomedical Advanced Research and Development Authority. Vaxart received a $13.9M contract from BARDA in September 2015 to support the advanced development of more effective influenza vaccines to ultimately improve seasonal and pandemic influenza preparedness. The contract was increased to $15.7M in 2017.
ESTA

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08:04 EDT Establishment Labs transitions to direct sales force in Germany, Spain - Establishment Labs announced that it has entered into definitive asset purchase agreements with its German and Spanish exclusive distributors to acquire certain assets. Under the terms of the agreements, Menke Med and Motiva Matrix, respectively the exclusive distributors of Motiva in Germany and Spain, will transfer distribution arrangements to Establishment Labs. Establishment Labs will acquire all product inventory and customer relationships, effective November 26 in Germany and October 29 in Spain. The company currently sells products in more than 60 countries and employs a direct sales force strategy in a number of these markets, including Brazil, United Kingdom, France, Sweden, Denmark and Norway.
CMT CCK

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08:04 EDT Core Molding names David Duvall as new CEO - Core Molding (CMT) announced that its Board of Directors has appointed David Duvall as its new President and CEO. Duvall will assume his position effective October 22, 2018 and will become a member of the company's Board of Directors. The company also announced that Kevin Barnett, the current President and CEO, will retire from Core Molding on October 22, 2018 and has resigned from its Board of Directors. Duvall respectively, served most recently as the President, Equipment & Tools Division, of Signode Industrial Group, a subsidiary of Crown Holdings (CCK).
BCE

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08:04 EDT BCE appoints Mirko Bibic as COO - BCE appointed Mirko Bibic as Chief Operating Officer for BCE and Bell Canada. Rizwan Jamal, President of Bell Residential and Small Business; Blaik Kirby, President of Bell Mobility; and Tom Little, President of Bell Business Markets report to Bibic in his role as COO. Bibic has been Executive Vice President of Corporate Development. Bell also appointed Wade Oosterman as Vice Chair of BCE and Bell Canada.
CTSH

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08:02 EDT Cognizant to acquire Softvision, terms not disclosed - Cognizant announced it has entered into a definitive agreement to acquire Softvision, a privately-held digital engineering and consulting company focused on agile development of innovative software solutions and platforms. The transaction is expected to close in the fourth quarter of 2018 subject to the satisfaction of the closing conditions, including regulatory review. Terms are not being disclosed.
PTIE

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07:55 EDT Pain Therapeutics awarded $3.5M research grant from NIH for PTI-125 - Pain Therapeutics announced that it has been awarded an approximately $3.5M research grant from the National Institutes of Health, or NIH, to support a Phase II program with PTI-125, the company's drug candidate to treat Alzheimer's disease. The NIH's National Institute on Aging awarded the company this clinical research grant following an in-depth, peer-reviewed evaluation of PTI-125 for scientific and technical merit. The NIH grant award will enable the company to conduct clinical tests of PTI-125 in patients with Alzheimer's disease. In Q4, the company expects to initiate a Phase II study in Alzheimer's patients using PTI-125. In mid-2019, the company expects to initiate a second Phase II study in Alzheimer's patients using PTI-125.
RGNX

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07:55 EDT Regenxbio completes dosing fourth cohort in Phase 1 trial of wet AMD candidate - Regenxbio has completed dosing of the fourth cohort of six patients in a Phase I clinical trial evaluating RGX-314 for the treatment of wet age-related macular degeneration - wet AMD or nAMD. A total of 24 subjects have been dosed in the trial. An updated summary of Phase I study results are to be presented at the American Academy of Ophthalmology 2018 Annual Meeting in Chicago. RGX-314 is currently being evaluated in a Phase I study in adult subjects with wet AMD in the U.S. to evaluate the safety and tolerability of RGX-314 at 24 weeks after a single dose administered by subretinal delivery. Primary endpoints include safety and tolerability and secondary endpoints include ocular examinations, visual acuity, imaging and the need for additional anti-VEGF therapy.
DHXM

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07:55 EDT CPLG to join forces with Pullman Licensing to expand in Russia, CIS and Baltics - CPLG is further extending its international footprint by agreeing to acquire a 49% share in Pullman Licensing, a leading Russian licensing agency owned by Igor Kuleshov, President and owner of Gulliver Holdings, one of Russia's premier toy and clothing manufacturers and distributors. CPLG and Pullman are expected to collaborate on the overall management and operations, utilizing CPLG's international industry knowledge and expertise and Pullman's local strength in the market. Pullman will maintain the existing staff in their Moscow office and look to expand the existing portfolio of rights. Pullman's current portfolio includes Nickelodeon, Paramount, ROI Visual and Emoji across Russia, the Commonwealth of Independent States, and the Baltics. The venture, to be named CPLG Pullman, will also represent certain of CPLG's portfolio, including Line Friends, one of the fastest growing global character brands, and Archie Comics, with further representation to be announced shortly. CPLG is owned by DHX Media.
ARWR

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07:50 EDT Arrowhead trading resumes
GM...

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07:48 EDT GM's Cadillac beat Tesla in CR's ranking of automated driving systems - GM's (GM) Cadillac beat Tesla (TSLA) in ranking of automated driving systems, according to Consumer Reports. The report said Cadillac's Super Cruise does the best job of monitoring if a driver is paying attention when they take their hands off the steering wheel. In CR's rankings, Tesla's Autopilot came in second, followed by Nissan (NSANY)/Infiniti's ProPilot Assist and then Volvo's (VOLVY) Pilot Assist system. Autopilot scored highly for its capabilities and ease of use, while Nissan's system was better at keeping drivers engaged. Volvo scored comparatively lower. Reference Link
ARAY

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07:42 EDT Accuray's Radixact cancer treatment system used for first time in India - Accuray announced that the clinical team at Healthcare Global Enterprises, Kolkata, India, has treated the first patient in India using the Radixact System.
FLS

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07:38 EDT Flowserve expands board to 11 directors - Flowserve announced that its board of directors has elected John Garrison, Jr. and Michael McMurray as independent directors, effective immediately. With the addition of Garrison and McMurray, the Flowserve board expands to eleven directors.
SAIC

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07:38 EDT SAIC awarded three GSA-led Center of Excellence IT modernization contracts - The U.S. General Services Administration awarded Science Applications International Corp. three GSA-led Information Technology modernization Centers of Excellence contract awards to support the U.S. Department of Agriculture. As part of GSA's government-wide IT modernization plan, the CoEs provide agencies with consulting, acquisition, and IT engineering services to improve the way agencies design services and interact with their customers. Under the initiative, SAIC was awarded the following: A single-award task order to provide program management, data science, organizational change management, and training support to more than 100,000 personnel within the USDA. A single-award blanket purchase agreement with firm-fixed-price task orders to provide professional services to develop and deploy advanced analytics and data visualization capabilities within USDA's mission areas. SAIC teams will evaluate alternatives across technologies, including blockchain, to develop and implement solutions to infuse the Voice of the Customer and enhance USDA's mission delivery. A multiple-award blanket purchase agreement to support DevSecOps transformation. Additionally, work includes the migration of more than 800 applications and data center consolidation.
OPHT

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07:38 EDT Ophthotech completes patient recruitment for Phase 2b clinical trial of Zimura - Ophthotech announced completion of patient recruitment for its Phase 2b clinical trial of Zimura, the company's complement factor C5 inhibitor, monotherapy in patients with geographic atrophy secondary to dry age-related macular degeneration, or AMD. Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of AMD. A total of 286 patients have been enrolled into this randomized, double-masked, sham controlled multi-center clinical trial. This clinical trial is designed to assess the safety and efficacy of various Zimura dosing regimens over 12 months. Patients will continue to be treated and monitored until month 18.
T

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07:38 EDT AT&T says plans to offer 5G Evolution in over 400 markets by year-end - AT&T this morning the next 99 new 5G Evolution markets, commenting "This brings, our total number of markets with these technologies to 239 and we plan to offer 5G Evolution in over 400 markets by year's end. In the first half of 2019 we plan to offer nationwide coverage, making 5G Evolution available to over 200 million people. We've also extended availability of our LTE-LAA technology to now offer a better wireless experience through LTE-LAA wireless technology in parts of 20 cities, coming to at least 24 cities this year. With LTE-LAA, the network technologies have a peak theoretical wireless speed for capable devices of 1 gigabit per second."
CP

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07:37 EDT Canadian Pacific sets financial targets for 2018-2020 - Sees: Volume compound annual growth rate of mid-single digits, measured in Revenue Ton-Miles; Double-digit CAGR in adjusted diluted EPS; Continued margin improvement through cost control and operating leverage; Capital expenditures of approximately $1.6B per year. Key assumptions for 2018-2020 targets: Exchange rate of 1.30 CAD/USD; On-Highway Diesel price of $3.20 USD/US gallon; Pension income consistent with 2018; Annualized effective tax rate of approximately 25%, excluding discrete items such as foreign-exchange gains or losses on U.S. dollar-denominated debt and any effects of changes in tax rates.
ARWR JNJ

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07:37 EDT Arrowhead enters $3.7B licence, collaboration agreement with Janssen - Arrowhead Pharmaceuticals (ARWR) announced that it entered into a license and collaboration agreement with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to develop and commercialize ARO-HBV. In addition, Arrowhead entered into a research collaboration and option agreement with Janssen to potentially collaborate for up to three additional RNA interference, or RNAi, therapeutics against new targets to be selected by Janssen. The transactions have a combined potential value of over $3.7B for Arrowhead. Under the terms of the agreement, Arrowhead will receive $175M as an upfront payment. Separately, Johnson & Johnson Innovation - JJDC, Inc., JJDC, will make a $75M equity investment in Arrowhead at a price of $23.00 per share of Arrowhead common stock. Arrowhead is eligible to receive up to approximately $1.6B in milestone payments for the HBV license agreement, including a $50M milestone payment linked to a Phase 2 study. Arrowhead is also eligible to receive approximately $1.9B in option and milestone payments for the collaboration agreement related to up to three additional targets. Arrowhead is further eligible to receive tiered royalties up to mid teens on product sales. Under the agreement, Janssen receives a worldwide exclusive license to the ARO-HBV program, Arrowhead's third-generation subcutaneously administered RNAi therapeutic candidate being developed as a potentially curative therapy for patients with chronic hepatitis B virus infection. Beyond AROHBV1001, Arrowhead's ongoing Phase 1/2 study of ARO-HBV, Janssen will be wholly responsible for clinical development and commercialization. Janssen can also select up to three new targets, against which Arrowhead will develop clinical candidates. These potential new candidates will leverage Arrowhead's proprietary TRiM platform, and do not include Arrowhead's current pipeline. Arrowhead will perform discovery, optimization, and preclinical development, entirely funded by Janssen, sufficient to allow the filing of a U.S. Investigational New Drug application or equivalent, at which time Janssen will have the option to take an exclusive license. If the option is exercised, Janssen will be wholly responsible for clinical development and commercialization. The closing of the transactions is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and is expected to close during the fourth quarter of 2018.
SIGA

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07:35 EDT Siga Technologies enters into CRADA with USAMRIID for TPOXX - SIGA Technologies announced that it has entered into a Cooperative Research and Development Agreement with the United States Army Medical Research Institute of Infectious Diseases. This CRADA will focus on Good Laboratory Practice studies of TPOXX for post-exposure prophylaxis using a U.S. Food and Drug Administration-approved non-human primate model of TPOXX efficacy against smallpox infection. PEP regimens are designed to prevent infection in individuals who have known or potential exposure to an infectious agent but are not symptomatic. Such regimens have been used successfully to reduce the impact of other infections. The FDA has already approved the oral formulation TPOXX for the treatment of smallpox, and its use in the PEP setting could provide significant potential benefit in the event of an outbreak.
ARWR JNJ

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07:34 EDT Arrowhead enters $3.7B licence, collaboration agreement with Janssen
CMI ISUZY

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07:34 EDT Cummins, Isuzu Motors sign LOI to evaluate partnership opportunities - Cummins (CMI) and Isuzu Motors (ISUZY) announced that they have signed a Letter of Intent to jointly evaluate opportunities to deliver globally competitive products. Each company has committed to assign a team of individuals over the next few months to explore potential opportunities in product technology development, service and other areas of collaboration with the potential for a longer-term partnership for the next generation of diesel and natural gas based internal combustion powertrains as well as new powertrain technologies such as electrification. Diesel engines will continue to be the power leader for the foreseeable future in commercial vehicle and off-highway markets. A long-term partnership would enable both companies to grow globally.
AGN

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07:32 EDT Allergan's CoolSculpting cleared by FDA to treat area below jawline - Allergan's CoolSculpting treatment received FDA clearance to treat the submandibular area. In addition, the FDA clearance was expanded to include patients with a BMI of up to 46.2 when treating the submental and submandibular areas. This recent clearance makes CoolSculpting the first and only nonsurgical fat reduction treatment to contour the area below the jawline and improve the appearance of lax tissue in conjunction with submental fat treatments.
CP

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07:30 EDT Canadian Pacific raises FY18 guidance
ARWR

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07:25 EDT Arrowhead trading halted, news pending
CMRX

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07:13 EDT Chimerix study shows correlation of Adv burden, allo-HCT recipients mortality - Chimerix announced the full analysis of adenovirus, or AdV, viral load dynamics and all-cause mortality in pediatric patients. These data from the AdVance study, the first large, multi-center study of AdV incidence, natural history, management and clinical outcomes in allogeneic hematopoietic cell transplant, or allo-HCT, recipients will be presented at IDWeek. Prior to the AdVance study, the epidemiology of AdV after allo-HCT has been generally understood via single-center studies, with little data on the correlation between AdV viral load and risk of mortality. Historically, acceptance of virologic endpoints as surrogates for clinical outcomes such as survival have been important in progressing antiviral development in other viral diseases.
IZEA

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07:09 EDT Izea reports record quarterly bookings of $9.5M for Q3 - IZEA Worldwide reported total bookings of $9.5M for Q3, a 20% increase compared to $7.9M in the same quarter of the prior year. "We are excited by the momentum we have coming out of the third quarter," said Ted Murphy, IZEA's chairman and CEO. "Managed Services bookings saw a strong rebound from the previous quarter and were up 62% from Q2 to $4.4M in Q3. The concentrated effort we have put towards building and diversifying our pipeline over the past several quarters is beginning to pay off. Our new opportunity pipeline value to date is up 32% year-over-year, with a 50% increase in the overall number of opportunities during that same period. This is our fourth consecutive quarter of year over year pipeline growth."
AKTS

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07:08 EDT Akoustis delivers first RF BAW filter order, receives second order for AKF-1938 - Akoustis announced the company shipped its first XBAW RF filter products and recorded product revenue during the September quarter, in-line with earlier expectations. Pre-production orders for the company's new 3.8 GHz high frequency AKF-1938 RF filter have been delivered. Akoustis has received a second production order from the customer for delivery before the end of 2018. The customer, an OEM with over $1B in annual revenues, specializes in non-mobile communication systems including phased-array radar solutions and high-performance RF transceivers.
BBX BXG

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07:06 EDT Bluegreen Vacations provides update on Hurricane Florence impact - BBX Capital (BBX), owner of 90% of Bluegreen Vacations (BXG), provided an initial assessment of the impact of Hurricane Florence on its operations. The company has nine Club Resorts and two Club Associate Resorts that were in the primary path of Hurricane Florence in North and South Carolina. Preliminary reports indicate that physical damage was generally limited to water intrusion in rooms and common areas of the resorts. However, the company experienced cancelations in reservations, sales tours, rentals and other services. As of September 30, all of the company's resorts and sales centers were fully operational, with the exception of the two Club Associate resorts in Bern, North Carolina, both of which are expected to reopen in October. At this time, the company estimates that the storm caused a loss of system-wide sales in Q3 in the $5.0M-$5.8M range, with the related EBITDA impact estimated to be $2.0M-$2.3M. The company also expects an additional impact on system-wide sales and EBITDA in Q4 from the ongoing flooding from Hurricane Florence, as well as the impact of reduced vacation package sales which are expected to impact travel and sales in Q4. Those costs are not expected to be material to the company's results of operations, financial position or cash flows.
ZFGN

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07:05 EDT Zafgen to present data from multiple ZGN-1258 studies at FPWR - Zafgen announced results from three nonclinical, investigational new drug, or IND, -enabling studies of ZGN-1258 to be presented at the Foundation for Prader-Willi Research, or FPWR. ZGN-1258 is Zafgen's second-generation, novel investigational MetAP2 inhibitor for the treatment of rare metabolic disorders, including Prader-Willi syndrome, or PWS, designed to decrease hyperphagia, change the way the body metabolizes fat, and reduce fat mass. Together, these studies demonstrate nonclinical efficacy and safety for ZGN-1258 and support further development. In one poster, the effects of ZGN-1258 are characterized in mouse models of hyperphagia and obesity. In a second poster, in three mouse models that share features with PWS, ZGN-1258 demonstrates improvement in behavioral manifestations commonly observed in PWS, including low physical activity, anxiety and obsessive-compulsive behaviors. A third poster shows a comparison of the effects of ZGN-1258 and Zafgen's first generation MetAP2 inhibitor on safety measures, including measures of thrombotic risk, demonstrating a highly differentiated profile for ZGN-1258 on endothelial cell effects.
VKTX

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07:05 EDT Viking Therapeutics: VK2809 Phase 2 study results selected for presentation - Viking Therapeutics announced that the results from the company's Phase 2 study of VK2809 in patients with non-alcoholic fatty liver disease and elevated low-density lipoprotein cholesterol have been selected for presentation as part of the oral late-breaker session of The Liver Meeting 2018. The presentation will highlight data from the recently completed Phase 2 clinical trial of VK2809. The Liver Meeting 2018, which is the annual meeting of the American Association for the Study of Liver Diseases, is being held November 9 - 13 in San Francisco, CA. As previously reported, the top-line data from this study showed that the trial successfully achieved its primary endpoint, with patients receiving VK2809 demonstrating statistically significant reductions in LDL-C compared with placebo. In addition, the trial's secondary endpoint was achieved, with VK2809-treated patients experiencing statistically significant reductions in liver fat content compared with placebo, and a majority experiencing greater than or equal to50% reductions. VK2809 also demonstrated encouraging safety and tolerability in this study, with no serious adverse events reported among patients receiving VK2809 or placebo.
ALNY

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07:04 EDT Alnylam reports updated 'positive' results from Phase 1/2 study of lumasiran - Alnylam Pharmaceuticals announced updated positive results from its Phase 1/2 clinical study of lumasiran, an investigational, subcutaneously administered RNAi therapeutic targeting glycolate oxidase for the treatment of primary hyperoxaluria type 1. The company also announced the initiation of ILLUMINATE-A, a global Phase 3 pivotal trial of lumasiran in children and adults with PH1. The study will enroll approximately 30 patients and is designed in alignment with FDA with a primary endpoint based on reduction of urinary oxalate at six months. Alnylam expects to report topline results from ILLUMINATE-A in late 2019 and, if positive, submit filings for regulatory approval starting in early 2020. New results from the Phase 1/2 study were as of a data cut-off date of August 15, 2018. Lumasiran demonstrated a mean maximal reduction in urinary oxalate of 75 percent relative to baseline across cohorts dosed at 1 mg/kg monthly or 3 mg/kg monthly or quarterly. The mean reduction relative to baseline was 66 percent when measured 28 days post last dose. All patients achieved oxalate lowering to less than 1.5 times the upper limit of normal. Among patients receiving 3 mg/kg monthly or quarterly doses of lumasiran, 83 percent achieved urinary oxalate levels within the normal range. Furthermore, lumasiran-treated patients in all cohorts experienced a mean maximal decrease of 76 percent in the ratio of urinary oxalate to creatinine - a corroborative measure of oxalate reduction that addresses the variability that is inherent to 24 hour urine collections. The Phase 1/2 safety results in patients with PH1 were based on a median study duration of seven months since first dose. As of the data cut-off date, there were no discontinuations from study treatment. Serious adverse events were reported for one patient receiving placebo and five patients receiving lumasiran; none were related to study drug. The placebo patient experienced acute pyelonephritis and kidney stones. The lumasiran patients with SAEs included one patient with vomiting, one patient with abdominal pain, fever and vomiting, one patient with gastroenteritis, and two patients with kidney stones. Adverse events were reported in three patients during placebo dosing and 19 patients after lumasiran dosing. The majority of AEs were mild or moderate in severity and were assessed as unrelated to study drug. Injection site reactions were reported in three patients receiving lumasiran. ISRs were mild or moderate in severity and were self-limiting. Lumasiran was not associated with any clinically significant adverse laboratory findings. In patients receiving lumasiran, plasma glycolate levels increased consistent with the pharmacology of lumasiran and results from healthy volunteers in Part A of the Phase 1/2 study. This increase was not associated with any safety findings.
ESNC

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07:02 EDT EnSync announces sale of Solar-Plus-Storage PPA with Kona Brewing - EnSync announced the sale of a 20-year power purchase agreement with Kona Brewing Company to an undisclosed investor. The agreement will finance a solar-plus-energy storage system at the beer company's new brewery in Kailua Kona, Hawaii. Construction will be completed early next year. Projected to meet one-quarter of the brewery's electricity needs, the installation will consist of a 336-kilowatt roof-mounted photovoltaic system and an EnSync DER SuperModule that contains a 122 kW-hour battery system to capture and store excess solar energy generation. The project also includes the Matrix Energy Management system, which uses DER Flex IoE technology to find and deliver the lowest-cost, most reliable electricity from multiple sources. Kona Brewing expects to produce a peak output of 6,875 cans of sun-powered beer per hour with the new system. EnSync Energy's tailored project development and financing support enables investors and local energy consumers to commit to clean energy cost savings while furthering Hawaii's state goal to achieve 100% renewable energy by 2045. EnSync Energy has contracted 27 commercial projects in Hawaii, which will account for more than $42.8M in electricity sales over the terms of the agreements.
IDXG

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07:00 EDT Interpace Diagnostics signs agreement with Georgia's Piedmont Healthcare - Interpace Diagnostics has entered in to an agreement with Piedmont Healthcare, Georgia's largest healthcare system serving 2 million patients annually. The agreement enables all physicians across the Piedmont Healthcare Network to use PancraGEN for patients with indeterminate pancreatic cysts or other pancreaticobiliary lesions. The company recently expanded the applications for PancraGEN to include biliary strictures and solid lesions as well as the publication of several peer-reviewed papers and updated guidelines that support the utility of molecular markers in identifying pancreatic cancer.
VFC

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06:56 EDT VF Corp. to sell Reef brand to The Rockport Group, terms not disclosed - VF Corporation announced that it has entered into a definitive agreement to sell the Reef brand to The Rockport Group of Newton, Massachusetts. A leading maker of casual and dress shoes, Rockport is a portfolio company of Charlesbank Capital Partners, a middle-market private equity firm. Reef will operate as an independent global brand under The Rockport Group, and will maintain its Carlsbad, California, headquarters. The transaction, which is expected to close in October 2018, is subject to customary closing conditions and regulatory approvals for a closing to occur. Terms of the agreement were not disclosed.
SRPT

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06:50 EDT Sarepta gene therapy showed functional improvements across all measures - Sarepta Therapeutics announced yesterday that at the 23rd International Congress of the World Muscle Society in Mendoza, Argentina, Jerry Mendell, M.D., of Nationwide Children's Hospital presented updated results from its gene therapy clinical trial assessing AAVrh74.MHCK7.micro-Dystrophin in individuals with Duchenne muscular dystrophy. Dr. Mendell presented the following updated data on the four patients enrolled in the study: All patients showed robust expression of transduced micro-dystrophin, which is properly localized to the muscle sarcolemma, as measured by immunohistochemistry. Mean gene expression for the study, as measured by percentage of micro-dystrophin positive fibers was 81.2% and the mean intensity of the fibers was 96.0% compared to normal control. All post-treatment biopsies showed robust levels of micro-dystrophin as measured by Western blot, with a mean of 74.3% compared to normal utilizing Sarepta's method, or 95.8% compared to normal pursuant to Nationwide Children's quantification of Sarepta's method that adjusts for fat and fibrotic tissue. Gene expression for the fourth patient was robust, as follows: As measured by immunohistochemistry, micro-dystrophin positive fibers was 96.2% and the mean intensity of the fibers was 160.0% compared to normal control. As measured by Western blot, patient 4 showed robust levels of micro-dystrophin, with a mean of 182.7% compared to normal utilizing Sarepta's method, or 222% compared to normal pursuant to Nationwide Children's quantification of Sarepta's method that adjusts for fat and fibrotic tissue. In all patients, expression of micro-dystrophin was associated with significant expression and up-regulation of the dystrophin-associated protein complex, an additional indication of functionality of dystrophin. All patients showed significant decreases of serum creatine kinase levels at last measure, with a mean reduction of CK of over 78% from baseline. Doug Ingram, Sarepta's president and CEO, said, "The encouraging results that we previously saw and reinforced in the fourth patient strengthen our resolve to rapidly move to a confirming trial and, assuming successful, to bring this therapy to the Duchenne community around the world with a sense of urgency."
MRK

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06:46 EDT Merck's DELSTRIGO meets primary endpoint in Phase 3 DRIVE-SHIFT study - Merck announced the first presentation of data from the Phase 3 DRIVE-SHIFT trial evaluating a switch of medication to DELSTRIGO, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg), in adults with HIV-1 infection who demonstrated virological suppression for at least six months on a stable antiretroviral treatment regimen. The study met its primary endpoint of non-inferior efficacy as measured by the proportion of participants who switched to DELSTRIGO and had plasma HIV-1 RNA levels less than50 copies/mL at Week 48 compared to the proportion of participants who continued on their baseline regimen and had HIV-1 RNA levels less than 50 copies/mL at Week 24. These study results will be presented today as a late-breaking oral presentation at IDWeek 2018 taking place Oct. 3-7, 2018, in San Francisco.
LLY

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06:36 EDT Boehringer Ingelheim, Eli Lilly announce empagliflozin meets primary endpoint - Boehringer Ingelheim and Eli Lilly announced that empagliflozin met the primary efficacy endpoint, defined as a change from baseline in A1C versus placebo after 26 weeks of treatment, for all doses investigated in the Empagliflozin as Adjunctive to inSulin thErapy, or EASE, Phase III program in adults with type 1 diabetes. The EASE program results were published online in Diabetes Care ahead of print and presented at the 54th EASD Annual Congress. Empagliflozin is currently not approved for use in type 1 diabetes. The EASE-2 study evaluated doses of 10 and 25 mg of empagliflozin as an adjunct to insulin over 52 weeks, while the EASE-3 study evaluated doses of 2.5, 10, and 25 mg of empagliflozin as an adjunct to insulin over 26 weeks. In EASE-2, placebo-corrected mean change from baseline in A1C at week 26 was -0.54% and -0.53% for empagliflozin 10 and 25 mg, respectively. In EASE-3, placebo-corrected mean change from baseline in A1C at week 26 was -0.28%, -0.45% and -0.52% for empagliflozin 2.5 mg, 10 mg and 25 mg, respectively. In addition to reduction in A1C, empagliflozin treatment was effective on secondary endpoints, showing reductions in weight, decreases in blood pressure, and decreases in total daily insulin dose. In addition, data from continuous glucose monitoring in the EASE program indicates that patients treated with empagliflozin had improved glycemic variability and spent more time in range, although the data for the 2.5 mg dose are limited.There was no increase in the risk of investigator-reported hypoglycemic events, including severe hypoglycemia, with empagliflozin treatment, which was a key secondary endpoint in the trials. Additionally, a reduction in patient-reported hypoglycemic events was observed. The number of adjudicated diabetic ketoacidosis, or DKA, events was comparable between empagliflozin 2.5 mg and placebo, and higher than placebo with empagliflozin 10 and 25 mg. Apart from incidence of DKA, the safety profile observed in the EASE program was generally consistent with the previously reported safety profile of empagliflozin in adults with type 2 diabetes. Based on the totality of the EASE data, Boehringer Ingelheim has initiated regulatory discussions for empagliflozin as adjunct to insulin for adults with type 1 diabetes.
LYB

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06:36 EDT LyondellBasell's A. Schulman announces convertible special stock dividend - LyondellBasell announced that its wholly owned subsidiary, A. Schulman, Inc., has declared a quarterly dividend of $15.00 per share for A. Schulman's convertible special stock. The dividend is payable on November 1, 2018 to shareholders of record as of October 15. LyondellBasell acquired A. Schulman on August 21.
QTRH

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06:33 EDT Wi-LAN subsidiary signs license agreement with ESMT - Wi-LAN, a Quarterhill company, announced that WiLAN's wholly-owned subsidiary, Polaris Innovations, has granted a term license for certain patents owned by Polaris to Elite Semiconductor Memory Technology. The licensed patents relate to technology used in Dynamic Random Access Memory, or DRAM, semiconductor devices. ESMT is a Taiwanese IC Design company offering DRAM, Flash, Mixed Signal and System Integrated Circuit products. The consideration paid by ESMT to Polaris and all other terms of the license agreement are confidential.
AGO

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06:26 EDT Assured Guaranty renews motion for appointment of receiver for PREPA - Assured Guaranty released comments regarding a new motion and form of complaint filed in Federal District Court in Puerto Rico today by two of its bond insurance subsidiaries, as well as National Public Finance Guarantee Corporation and Syncora Guarantee. The motion and form of complaint seek an order lifting the automatic stay to allow Assured Guaranty to seek relief before a court of competent jurisdiction, by filing the proposed complaint, to appoint a receiver for the Puerto Rico Electric Power Authority, or PREPA. Assured Guaranty stated that "PREPA is failing to fulfill its obligations to all of Puerto Rico's stakeholders, including its ratepayers and creditors. As a result of PREPA's defaults, Assured Guaranty and the other parties are entitled to the appointment of a receiver for PREPA (...) This entitlement to a receiver is automatic once PREPA's bonds default. Lifting the automatic stay and appointing a receiver for PREPA is necessary to ensure the collateral package securing PREPA's bonds is not diminished (...) Despite filing the motion, Assured Guaranty stands ready, and would prefer, to work cooperatively with the Financial Oversight and Management Board for Puerto Rico to consensually appoint a receiver for PREPA". Irrespective of PREPA's payment defaults on its bonds and its Title III bankruptcy filing, payments to holders of PREPA bonds insured by Assured Guaranty will continue to be paid without interruption for the life of the bonds.
MO...

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06:15 EDT Juul Labs files complaint with ITC against copycat products - Juul Labs announced that it has filed a complaint with the United States International Trade Commission alleging that multiple entities infringe the claims of several of Juul Labs' patents, and requesting the ITC prevent the continued importation, distribution, selling, and marketing of the identified products in the United States. The ITC action is part of Juul Labs' global efforts to defend the company's intellectual property from infringers, and also serves an important role in the company's effort to combat illegal underage use of Electronic Nicotine Delivery System products. The ITC complaint alleges that over 15 entities, based in China, the United States, and France, blatantly develop and sell products based on Juul Labs' patented technology. Juul Labs has begun a similar action in the United Kingdom. As indicated in the ITC Complaint, whereas Juul Labs implements strict manufacturing and quality controls during the manufacturing of its products, little is known about how most of the accused devices are manufactured. Similarly, whereas Juul Labs applies strict age-gating when selling its products through its website, many of the accused products appear to be sold with little or no real age-verification processes. Notably, in contrast to Juul's products, many of the accused copy-cat products include inappropriate flavors, seemingly directed to attract underage users - flavors like "Bubble Bubble," "Apple Juice" and "Sour Gummy." The ITC complaint follows Juul Labs' August trademark filing against 30 counterfeiters who were selling counterfeit products through the internet with no age verification. In addition, since 2018, Juul has worked to remove more than 17,000 improper listings from online marketplaces, including eBay (EBAY) and Amazon (AMZN). Publicly traded companies in the tobacco space include Altria Group (MO), British American Tobacco (BTI) and Philip Morris (PM).
LLY

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06:09 EDT Eli Lilly presents phase 2b trial data of dual GIP, GLP-1 receptor agonist - Results from a phase 2b clinical trial of Eli Lilly's dual GIP and GLP-1 receptor agonist showed strong and clinically meaningful blood sugar reduction and weight loss in people with type 2 diabetes. The six-month data, showing average HbA1c reductions of up to 2.4 percentage points and an average weight reduction up to 11.3 kg ,were presented at the 54th annual meeting of the European Association for the Study of Diabetes and simultaneously published in The Lancet. The weekly dual glucose-dependent insulinotropic polypeptide, or GIP, and GLP-1 receptor agonist integrates the action of both incretins into a single novel molecule, aiming to build upon the clinical benefits seen with a selective GLP-1 RA. Two statistical approaches were used to evaluate the efficacy of four doses of GIP/GLP-1 RA compared to placebo and dulaglutide 1.5 mg in people with type 2 diabetes. The first was a dose response model evaluating the effect regardless of discontinuation of treatment and use of rescue medication. An additional analysis identified the effect while on treatment and without use of rescue medication. At 26 weeks, the primary analysis showed a robust dose response compared to placebo throughout the entire dose range of GIP/GLP-1 RA included in the study. The safety profile of GIP/GLP-1 RA was similar to the GLP-1 RA class. The most commonly reported side effects were gastrointestinal-related, and dose-dependent. These events included nausea, diarrhea and vomiting which were mild to moderate and generally temporary, most often occurring during the titration period. Dulaglutide 1.5 mg had a similar side effect profile to previous studies. No participants in any of the treatment groups experienced severe hypoglycemia. A further study examining an optimal titration schedule to help manage GI side effects was conducted and will be presented next year. The safety and efficacy of Lilly's GIP/GLP-1 RA are being studied further in a large phase 3 clinical program that will be referred to as the SURPASS program. Phase 3 studies for type 2 diabetes are expected to begin no later than early 2019 and complete in late 2021. Lilly is evaluating next steps in the study of GIP/GLP-1 RA for obesity and other conditions.
BDRBF SIEGY

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06:07 EDT Bombardier signs $229M contract with Siemens - Bombardier Transportation (BDRBF) will continue to make an important contribution to the expansion of Deutsche Bahn's ICE 4 fleet as a Siemens' (SIEGY) partner and supplier. At the end of September, Bombardier signed a contract with Siemens for further cooperation as a supplier for Deutsche Bahn's new order for 18 7-car ICE 4 trains and 50 powered cars. The contract is valued at approximately $229M. Bombardier's scope represents around one third of the overall project. The new order is part of a framework agreement for the development and supply of key components for up to 300 ICE 4 high-speed trains for Deutsche Bahn, which was signed with Siemens in 2011. Bombardier is responsible for the exterior design, the production and design of the steel car bodies, the delivery of the trailer bogies and around 30 percent of the final assembly of the entire ICE 4 fleet.
AHH

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06:05 EDT Armada Hoffler to recognize $5M purchase option sale gain over four quarters - Armada Hoffler has reached an agreement to sell its at-cost purchase option to the developer of The Residences at Annapolis Junction for $5.0M. The company has agreed to allow the developer to refinance the project and extend the maturity of the mezzanine loan in order to realize the full potential value upon expected stabilization in 2019. Although the full option payment is expected to be received in Q4, as a result of this change in strategy, the proper accounting treatment will be to recognize the $5.0M profit over the next four quarters. The company expects the developer to close on these transactions in Q4, at which time the company expects the developer to pay down the mezzanine loan balance by over $10.0M. The company is updating FY18 Normalized FFO guidance to $1.00-$1.03.
TM SFTBF

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06:05 EDT Toyota, SoftBank agree on partnership to establish JV for new mobility services - Toyota (TM) and SoftBank (SFTBF) have agreed to form a strategic partnership to facilitate the creation of new mobility services, and plan to establish a joint venture company, MONET Technologies Corporation, before the end of the 2018 fiscal year. The objective of MONET is to help realize a safer and more comfortable mobility society by combining SoftBank's corporate philosophy, "Information Revolution - Happiness for everyone," with Toyota's vision of "Mobility for All." MONET will provide coordination between Toyota's Mobility Services Platform, Toyota's information infrastructure for connected vehicles, and SoftBank's Internet of Things Platform, which was built to create new value from the collection and analysis of data acquired from smartphones and sensor devices. For the first phase, MONET plans to roll out just-in-time vehicle dispatch services for local public agencies and private companies throughout Japan. These services, which will include on-demand transportation through regional partnerships and corporate shuttles, will be provided in tune with user demand. By the second half of the 2020s, MONET plans to roll out Autono-MaaS*1 (autonomous mobility as a service) businesses using e-Palette, Toyota's dedicated battery electric vehicle for mobility services that can be used for various purposes, including mobility, logistics, and sales. Possibilities include demand-focused just-in-time mobility services, such as meal deliveries vehicle where food is prepared while on the move, hospital shuttles where onboard medical examinations can be performed, mobile offices, and many more. MONET also intends to roll out these businesses in Japan with an eye to future expansion on the global market. Reference Link
BX

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06:02 EDT Blackstone to acquire Clarus, terms not disclosed - Blackstone announced that it has agreed to acquire Clarus, a leading global life sciences investment firm that has raised $2.6B since its founding. Clarus, with offices in the life sciences hubs of Boston and San Francisco, is focused on funding growth-stage investments, often in partnership with major biopharmaceutical companies through R&D collaborations. These investments bring to market promising new medicines that improve patients' lives. Clarus is led by a team of seasoned experts who have invested in more than 50 companies in the biopharmaceutical, medical device and diagnostic sectors-as well as across multiple disease areas, primarily in the oncology space. Upon closing of the transaction, Nick Galakatos, PhD, Managing Director of Clarus, will become Head of Blackstone Life Sciences. Galakatos co-founded Clarus in 2005 and has over 30 years of experience in the healthcare sector. Clarus' team includes both clinical and investing experts with deep experience in the industry, including prior sector experience with 10 of the world's leading life sciences companies. Blackstone's acquisition of Clarus is subject to customary closing conditions and is expected to close in the fourth quarter of 2018.
BX

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06:01 EDT Blackstone to acquire Clarus
ELTK

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05:41 EDT Eltek receives non-compliance notice from Nasdaq - Eltek announced that on October 2, it received a notice from the Listing Qualifications Department of Nasdaq advising the company that as of October 1, the company did not maintain stockholders' equity of $2.5M, nor does it meet the alternatives of market value of listed securities or net income from continuing operations, and therefore is not in compliance with the applicable listing rule. Eltek has 45 calendar days, until November 16, to submit a plan to regain compliance. If the plan is accepted, the Listing Qualifications Department of Nasdaq can grant an extension of up to 180 calendar days from October 2, to allow the company to evidence compliance.
MERC

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05:38 EDT Mercer to acquire Daishowa-Marubeni International for $359.2M - Mercer International announced that it has entered into an agreement with Marubeni Corporation, Nippon Paper Industries Co., Ltd., and Daishowa North America Corporation to acquire all of the issued and outstanding shares of DMI for consideration of $359.2 million, which includes minimum working capital of $85.7 million. DMI owns 100% of a bleached kraft pulp mill in Peace River, Alberta and has a 50% interest in the Cariboo Pulp and Paper Company, or CPP, a joint venture which operates a bleached kraft pulp mill in Quesnel, British Columbia. As a result of this transaction, Mercer's annual production capacity for pulp will increase by approximately 41% to 2.2 million ADMTs, and surplus energy will increase by approximately 8% to 890,000 MWhs. Further, the acquisition of DMI will add NBHK pulp to Mercer's current product mix as well as provide the Company with an expanded market presence in Asia. DMI also holds 20-year term renewable governmental Forest Management Agreements and Deciduous Timber Allocations in Alberta with an Annual Allowable Cut, or AAC, of approximately 2.4 million cubic meters of hardwood and 400,000 cubic meters of softwood. The transaction is subject to customary closing conditions, including receipt of requisite regulatory anti-trust approvals. In connection therewith, Mercer has arranged a fully committed financing in the amount of $350 million to finance the acquisition. The transaction is expected to close in the fourth quarter of 2018.
AEG

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05:35 EDT Aegon: Transamerica settles universal life litigation - Aegon's subsidiary Transamerica announces an agreement that would resolve litigation challenging certain monthly deduction rate adjustments on universal life insurance policies in the United States. This settlement for an amount of $195M removes the uncertainty of ongoing litigation for the company and its customers. Transamerica's universal life insurance policies permit the company to adjust monthly deduction rates up to a contractually guaranteed maximum, subject to certain conditions. Plaintiffs in lawsuits challenged increases to monthly deduction rates on approximately 70,000 universal life policies that were enacted in 2015 and 2016. Transamerica implemented these adjustments, necessitated by low long-term interest rates, changes in expectations as to future mortality experience, and other factors, and in accordance with the policies' contractual terms. The agreement creates a settlement class of all Transamerica policyholders that were subject to the 2015 and 2016 monthly deduction rate adjustments. The settlement will be filed with the United States District Court for the Central District of California on or about October 4, 2018, and is subject to court approval. Impacted policyholders will receive notice approved by the court with details of the settlement. While policyholders may choose to opt out, policyholders who participate in the settlement will receive a monetary award - either through the crediting to policy account values for policies in force or in cash for certain policies no longer in force - and protection against new monthly deduction rate increases on their policies for five years. In turn, these class members will release all claims related to or arising out of the monthly deduction rate increases. This will allow Transamerica to retain its monthly deduction rate increases. Under the terms of the settlement agreement, Transamerica will pay the settlement amount into a common fund, and absorb additional costs for attorneys' fees, class notice and administration. The capital and pre-tax IFRS impacts are expected to be in the range of the amount of the settlement.
CYAD

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05:33 EDT Celyad announces exclusive agreement for Horizon Discovery shRNA platform - Celyad announced an exclusive agreement with Horizon Discovery Group, for the use of its shRNA technology to generate Celyad's second non-gene-edited allogeneic platform. Celyad recently announced its first-in-class non-gene edited allogeneic CAR-T candidate, CYAD-101 a non-gene-edited allogeneic NKG2D-based CAR using the TIM. As a result of the agreement with Horizon Discovery, Celyad now also has access to a novel shRNA-based platform.
RHHBY

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05:31 EDT Baloxavir marboxil 'significantly reduced' time to improvement of flu symptoms - Genentech, a member of the Roche Group, announced that the Phase III CAPSTONE-2 study showed treatment with baloxavir marboxil significantly reduced the time to improvement of influenza symptoms versus placebo in people at high risk of serious complications from the flu, which includes adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, morbid obesity, or heart disease. Baloxavir marboxil was well-tolerated and no new safety signals were identified. Results of the study will be presented as a late-breaking oral presentation during IDWeek 2018 in San Francisco, California on Saturday, October 6, 2018. Baloxavir marboxil was discovered and developed by Shionogi & Co., Ltd., and is sold in Japan under the trade name Xofluza. "This is the first Phase III trial to demonstrate a significant, clinically meaningful benefit in people at high risk for complications from the flu for which there are no currently approved medicines," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "This study adds to the growing body of evidence supporting baloxavir marboxil as a potential first-in-class antiviral flu treatment, and we plan to discuss these data with health authorities around the world."
BB...

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05:15 EDT BlackBerry, Android, PLDT Enterprise enter partnership for MiCab app - BlackBerry (BB) announced it is expanding its partnerships with Android (GOOG, GOOGL) and PLDT Enterprise, through Smart Communications Inc. to provide MiCab, an online taxi-hailing platform, with an integrated, secure enterprise cloud solution that maintains data privacy, meets compliance and accelerates service delivery. The solution combines the ease-of-management and gold-standard security of BlackBerry Unified End-Point Management, with the flexible, customizable nature of Android Enterprise and network connectivity and devices from Smart. Together, the partners are enabling 'mobile-first' company MiCab to securely manage and connect thousands of drivers with millions of passengers via a fleet of tablet devices. In addition, BlackBerry is providing professional cybersecurity consulting services to MiCab.