Stockwinners Market Radar for November 04, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
ADMP | Hot Stocks20:04 EDT Adamis Pharmaceuticals says yet to receive FDA response on its ZIMHI injection - Adamis Pharmaceuticals announced that as of the close of business today, Adamis has not received any notice of action from the FDA on the company's New Drug Application relating to its ZIMHI high-dose naloxone injection product for the treatment of opioid overdose. As Adamis has previously stated, in connection with its acceptance for review of the NDA the FDA previously provided a PDUFA target agency action date of October 31, 2019. However, the FDA's review processes can extend beyond, and in some cases significantly beyond, anticipated or target completion or action dates due to the timing of the FDA's review process, FDA requests for additional data, information, materials or clarification, difficulties scheduling an advisory committee meeting, FDA workload issues, extensions resulting from the submission of additional information or clarification regarding information already in the submission, or other reasons. Adamis intends to make an announcement relating to FDA action concerning the NDA after it receives a notice of action or similar communication from the agency.
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SWI | Hot Stocks20:02 EDT SolarWinds expands its Ingram Micro distribution relationship - SolarWinds announced the expansion of its Ingram Micro distributor relationship. Tapping further into Ingram Micro's network as the distributor extends the SolarWinds market presence in the Asia-Pacific region. The expanded relationship will also support the availability and access to the full range of SolarWinds networking, IT systems, database management, and security technologies for Ingram Micro's customers. Ingram Micro will also be distributing the SolarWinds MSP product portfolio, including SolarWinds Remote Monitoring and Management, to its customers in Singapore, Hong Kong, Thailand, Indonesia, Malaysia, and the Philippines. In addition to distribution, Ingram Micro will be using the MSP portfolio to provide Network Operations Center services to their customers "to help them achieve scalability, provide new revenue opportunities, and to create an efficient service delivery resource."
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EVER... | Hot Stocks19:17 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: EverQuote (EVER) up 25.2%... FlexShopper (FPAY) up 13.6%... Chegg (CHGG) up 12.3%... Everbridge (EVBG) up 11.4%... RingCentral (RNG) up 10.2%... Iovance Biotherapeutics (IOVA) up 7.5%... ChemoCentryx (CCXI) up 5.8%... Jack Henry (JKHY) up 4.8%... Gaia (GAIA) up 3.5%... Tenet Healthcare (THX) up 2.0%... Hartford Financial (HIG) up 1.7%... Potbelly (PBPB) up 1.4%. ALSO HIGHER: Shenandoah Telecom (SHEN) up 11.4% after entering S&P 600 index... WWE (WWE) up 5.3% after expanding live event partnership in Saudi Arabia. DOWN AFTER EARNINGS: Myriad Genetics (MYGN) down 35.9%... Synchronoss (SNCR) down 15.9%... Shake Shack (SHAK) down 15.5%... Tandem Diabetes (TNDM) down 11.3%... McDermott International (MDR) down 10.4%... Diodes (DIOD) down 9.4%... Aaron's (AAN) down 8.0%... GroupOn (GRPN) down 6.7%... Mosaic (MOS) down 5.8%... Uber (UBER) down 5.1%... Maxar Technologies (MAXR) down 5.1%...Impinj (PI) down 4.3%... Endo International (ENDP) down 4.3%... Park-Ohio (PKOH) down 4.0%... Gladstone Investment (GAIN) down 3.9%... Capitala Finance (CPTA) down 3.8%... Helios Technologies (HLIO) down 2.3%... Marriott (MAR) down 2.2%... Prudential (PRU) down 1.8%... Hertz (HTZ) down 1.5%. ALSO LOWER: Yeti (YETI) down 4.6% after equity offering... Healthpeak Properties (HCP) down 1.8% after equity offering. Movers as of 18:45ET.
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VLRS | Hot Stocks18:48 EDT Volaris reports October traffic up 17.8% and capacity up 17.3% - Volaris reported October 2019 and preliminary year to date traffic results. In October capacity measured by ASMs, or Available Seat Miles, increased by 17.3% vs the same period of last year, with the demand measured by RPMs, or Revenue Passenger Miles, showing an increase of 17.8%. Volaris carried 1.9M passengers in total, or 18.1% increase vs the same period of last year, with a load factor increase of 0.4 pp vs the same period of last year, for a total of 85.8%.
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JCOM | Hot Stocks18:41 EDT j2 Global CEO: Our purpose is to generate free cash flow - In an interview on CNBC's Mad Money, j2 Global CEO Vivek Shah said: We are a portfolio of media brands... All our brands share highly recurring revenues... We are focused on performance marketing... We focus on delivering customers, not impressions... We are executing well.
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HCA | Hot Stocks18:30 EDT HCA Healthcare's Foster sells 19,477 common shares - In a regulatory filing, HCA Healthcare group president Jon M. Foster disclosed the sale of 19,477 common shares of the company at a price of $132.3462 on October 31.
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AUTL | Hot Stocks18:16 EDT Autolus Therapeutics gets acute lymphoblastic leukemia treatment orphan status - The FDA granted Autolus Therapeutics orphan status for its treatment of acute lymphoblastic leukemia. Reference Link
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BA | Hot Stocks17:53 EDT Bell-Boeing awarded $146.04M Navy contract modification for MV-22 upgrades - Bell-Boeing was awarded a $146,04M modification to a previously awarded cost-plus-fixed-fee, fixed-price-incentive-firm-target and firm-fixed-price contract. This modification exercises the option to upgrade nine MV-22 aircraft from the Block B to the Block C configuration, as well as planned maintenance intervals for eight MV-22 aircraft, in support of the common configuration-readiness and modernization, or CC-RAM, program. Work will be performed in Ridley Park, Pennsylvania and Fort Worth, Texas, and is expected to be completed in March 2022. FY18 and FY20 aircraft procurement and FY20 operation and maintenance funds in the amount of $146.04M will be obligated at time of award, $6,05M of which will expire at the end of the current fiscal year. The Naval Air Systems Command is the contracting activity.
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GRPN | Hot Stocks17:51 EDT Groupon down 7% at $2.79 per share after Q3 earnings miss
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MOS | Hot Stocks17:43 EDT Mosaic raises FY19 synergy target for Mosaic Fertilizantes by up to $50M - The company expects to exceed its previously announced synergy target for Mosaic Fertilizantes of $275M in 2019, by up to $50M. In addition, the company announced a new target of $200M in incremental annual EBITDA growth through ongoing business transformation efforts beginning in 2020 and ending by 2022. The company accelerated development of the Esterhazy K3 potash mine by an additional year, allowing the closure of the K1 and K2 shafts and elimination of brine management costs by mid-2022, as well as lower cost of production.
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NVDA ADBE | Hot Stocks17:38 EDT Adobe apps get 'supercharged' by Nvidia RTX GPUs - Nvidia (NVDA) said in a blog post earlier: "Adobe (ADBE) Dimension, Substance Alchemist and Premiere Pro get a big boost from RTX features, plus new Studio Driver and two new monster RTX Studio Workstations from BOXX. This year, we're helping supercharge creativity with NVIDIA RTX technology. Over 40 top creative and design applications are being accelerated by NVIDIA's RTX ray tracing and AI processors. Meaning, no more waiting on your PC. You're free to create at the speed of your imagination and see your work come to life instantly. Today, this boost is coming to three of Adobe's creative apps: Adobe Dimension, Substance Alchemist and Premiere Pro. From David LaChapelle to M. Night Shyamalan to Dave Grohl, the world's leading creative minds have descended upon Los Angeles this week for Adobe MAX to talk about how technology is improving the way they work.This year, we're helping supercharge creativity with NVIDIA RTX technology. Over 40 top creative and design applications are being accelerated by NVIDIA's RTX ray tracing and AI processors. Meaning, no more waiting on your PC. You're free to create at the speed of your imagination and see your work come to life instantly.Today, this boost is coming to three of Adobe's creative apps: Adobe Dimension, Substance Alchemist and Premiere Pro. Giving 2D Graphics a Third Dimension. 3D design has historically been restricted to programmers and engineers trained in expensive and complicated CAD and DCC tools. At Adobe MAX, the barriers to 3D are crashing down with new apps and capabilities coming to artists' creative portfolios. Adobe Dimension makes it easy and affordable for tens of millions of graphic designers and illustrators to step into 3D with stock assets, point-and-click materials and a powerful new NVIDIA RTX-accelerated ray-traced renderer. Adobe Dimension taps into dedicated ray-tracing processors on RTX GPUs to dramatically speed up rendering of 3D environments. This allows you to see dynamic lighting, beautiful reflections and soft shadows - all without the wait." Reference Link
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SNY | Hot Stocks17:33 EDT Sanofi says FDA approves Fluzone High-Dose Quadrivalent for older adults - The FDA has approved a supplemental Biologics License Application for Fluzone High-Dose Quadrivalent for use in adults 65 years of age and older. Fluzone High-Dose was approved by the FDA in 2009 as a trivalent influenza vaccine, including two influenza A strains and one influenza B strain. Fluzone High-Dose Quadrivalent contains an additional influenza B strain. Fluzone High-Dose Quadrivalent is given to people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine. This approval is the final step toward the company's complete transition to quadrivalent influenza vaccines in the U.S. Fluzone High-Dose Quadrivalent will be made available for immunization efforts during the 2020-2021 influenza season. Sanofi Pasteur will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through the end of the 2019-2020 influenza season.
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UBER | Hot Stocks17:31 EDT Uber sees FY19 gross bookings up 33%-35% - Raises FY19 adjusted EBITDA view to ($2.9B)-($2.8B) from ($3.2B)-($3B). Sees Q4 stock based compensation of $250M-$300M.
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MOS | Hot Stocks17:29 EDT Mosaic CEO expects 'much stronger year' in 2020 - "While the challenging market environment has persisted longer than we had anticipated, the actions we are taking give us an improved platform to deliver value and shareholder returns," said Mosaic President and CEO Joc O'Rourke. "We are seeing volumes move in North America and believe that strong volumes will lead to improved pricing. We believe that the bottom of the market is in and that 2020 will be a much stronger year for Mosaic and the customers we serve."
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MOS | Hot Stocks17:29 EDT Mosaic sees 'strong' North American 2019 fall application season - "Mosaic expects that the North American 2019 fall application season will be strong, but given distributors' high inventories, strong applications may not result in strong near-term revenue recognition. Both Phosphates and Mosaic Fertilizantes are expected to see full year volumes at the low end of the original guidance ranges. Potash sales volumes are expected to reflect the full 600,000 tonne curtailment announced in the quarter, primarily reflecting the delayed China contract, but including a modest, negative impact of fall weather on North American sales."
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UBER | Hot Stocks17:28 EDT Uber says Q3 was best quarter ever for rides - Says putting ballot measure to California voters in November 2020. Says targeting EBITDA profitability by FY21. Says cash and cash equivalents were $12.7B, which was up $900M from the Q2 due to the sale of $1.2B of senior unsecured notes and the closing of the $1B investment in ATG. Says competition has been fierce is some Uber Eats markets. Says willing to exit Uber Eats markets with low return of investment. Says ATG will be testing in Dallas in early November. Says a lot of shares will be unlocked on Wednesday. Comments taken from Q3 earnings conference call.
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MG | Hot Stocks17:28 EDT Mistras sees FY20 revenue up 'modest single digits' - Mistras states: "The company is still developing its 2020 full year budget, but preliminarily anticipates modest single digit top-line growth, while maintaining its year-to-date 2019 gross profit and operating margins and cashflow levels."
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MG | Hot Stocks17:23 EDT Mistras says seeing a weak Oil and Gas market - The company states: "Revenues and operating earnings were ahead of FY18 on a year to date basis through the first nine months, indicating a robust business. However, the strong momentum developed over the past two quarters encountered some headwinds coming into Q4 of 2019. The company is seeing a weak Oil and Gas market, and an overall Fall season that ended much sooner than anticipated. In particular, the company sees weaknesses in the Oil and Gas turnaround market that appears to be attributable to supply buildups earlier in the year, as well as refineries shifting resources to prepare for IMO2020. In addition, towards the middle of September 2019 and into October 2019, a note of caution unexpectedly arose amongst Oil and Gas customers, attributable primarily to increased macroeconomic uncertainty. It is the same note of caution that is being heard in various sectors, stemming from many factors, including trade tensions, negative European interest rates, and the slowdown in domestic GDP growth. Although the long-term outlook remains intact, these factors are clearly influencing current activity in the Oil and Gas market, resulting in pushouts of demand. Although the company feels very good about where it is and its outlook for the long term, this unexpected pause in the Oil and Gas end markets has created some immediate challenges, which will affect performance for the fourth quarter of 2019 and full year 2019."
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SHEN... | Hot Stocks17:19 EDT Shenandoah to replace Genomic Health in S&P 600 at open on 11/8 - Exact Sciences (EXAS) is acquiring Genomic Health (GHDX) in a transaction expected to be completed soon pending final conditions.
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TARO | Hot Stocks17:04 EDT Taro Pharmaceutical board approves $300M stock buyback - Taro board approved a $300 million share repurchase of ordinary shares. The timing, amount and value of any shares repurchased will be determined based on the company's ongoing assessments of the capital needs of the business, the market price of its stock, general market conditions and other factors. Shares will be repurchased using the company's existing sources of liquidity and free cash flow generated in the future.
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WWE | Hot Stocks17:01 EDT WWE up 3.5% to $55 per share after expanding its partnership in Saudi Arabia
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COLM | Hot Stocks17:01 EDT Columbia Sportswear names Timothy Boyle acting chairman - Columbia Sportswear Company announced that, in accordance with prior actions by the company's Board of Directors, President and CEO Timothy P. Boyle will serve as Acting Chairman of the Board following the passing of Gertrude Boyle. The Board intends to consider and take action regarding the formal appointment of a new Chairman of the Board at its next regularly scheduled Board meeting in January 2020. In addition to her leadership role within the company, Boyle held a substantial number of shares of the company's common stock. As of April 1, 2019, Gertrude Boyle held 9.4 million shares of the company's common stock, representing approximately 14% of the total shares outstanding. It is anticipated that the executor of Boyle's estate will be Sarah A. Bany, a longtime member of the Board and the sister of Timothy P. Boyle. The company understands that Boyle's estate plans call for the disposition of assets (which may include shares of the company's common stock) primarily to charitable foundations founded by family members, as well as directly to family members. The company further understands that under current tax law, family charitable foundations receiving shares of the company's common stock would have up to five years to sell those shares, subject to any extensions. The company intends to work with the parties to ensure the orderly transition of share ownership over the coming years.
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BB | Hot Stocks17:01 EDT BlackBerry announces COO Bryan Palma to leave company - BlackBerry announced that Bryan Palma, President and COO, has decided to leave the company to pursue other opportunities. Palma was appointed in January 2019 and oversaw the BlackBerry IoT Business. The BlackBerry IoT Business will report directly to John Chen, Executive Chairman and CEO.
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WWE | Hot Stocks17:00 EDT WWE expands live event partnership with GEA through 2027 - WWE and the Saudi General Entertainment Authority, GEA, have expanded their live event partnership through 2027 to include a second annual large-scale event. WWE and GEA also continue to work towards the completion of a media agreement in the MENA region.
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ORLY | Hot Stocks16:59 EDT O'Reilly Automotive chairman sells 20K shares of common stock - In a regulatory filing, O'Reilly Automotive disclosed that its chairman David O'Reilly sold 20K shares of common stock on November 1st. The total transaction size was $8.8M.
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DK | Hot Stocks16:55 EDT Delek US increases quarterly dividend 3.5% - Delek US announced its board declared a regular quarterly cash dividend of 30c per share. This represents a 3.5% increase from its previous regular quarterly dividend. Shareholders of record on November 18 will receive this cash dividend payable on December 2.
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MYGN | Hot Stocks16:50 EDT Myriad Genetics drops 30% after deletion of CPT codes impacts revenue - "In the fiscal first-quarter, Myriad made approximately an $11 million reserve adjustment for hereditary cancer revenue due to lower cash collections from small payers as a result of the deletion of the current procedural terminology, CPT codes 81211 and 81213. As a result, the company has revised its revenue accrual rate, and is forecasting lower hereditary cancer rates for fiscal year 2020. Myriad will provide a detailed summary of the changes on its fiscal first-quarter 2020 earnings call. Hereditary cancer volumes grew at a double-digit growth rate on a year-over-year basis for both the company's oncology and women's health business units," said the company.
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T RNG | Hot Stocks16:48 EDT AT&T, RingCentral partner over Unified Communications as a Service Solutions - AT&T (T) is expanding its relationship with RingCentral (RNG), making AT&T Office@Hand a lead offer for UCaaS solutions as part of its broad Voice and Collaboration portfolio. Based on the RingCentral platform, AT&T Office@Hand brings extensive mobile-first voice, video, online meetings, messaging and team collaboration capabilities to businesses and vertical sectors worldwide. In addition, AT&T and RingCentral plan to jointly develop capabilities and technologies that will further integrate with AT&T's network. "Businesses, no matter the size, get better results when employees can communicate and collaborate freely and effectively wherever they are," said Roman Pacewicz, Chief Product Officer, AT&T Business. "We've seen great success with the AT&T Office@Hand solution. Together with RingCentral, we're able to deliver premium cloud-based communication solutions that help more businesses improve customer engagement, drive employee productivity and streamline operations."
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FTEK | Hot Stocks16:44 EDT Fuel Tech awarded air pollution control orders totaling $2.1M - Fuel Tech announced the receipt of multiple air pollution control contracts from customers in the US and Europe. These awards have an aggregate value of approximately $2.1M. An order was received for a Selective Catalytic Reduction (SCR) system for an industrial process unit firing natural gas located in the United States. The scope includes Fuel Tech's SCR and UDI(TM) Urea Direct Injection technologies, along with ancillary systems to reduce nitrogen oxide (NOx) emissions from a metal processing line. Fuel Tech's UDI process, similar to our ULTRA(R) technology, provides the safe use of urea reagent where SCR is used to reduce NOx, eliminating the hazards associated with the transport, storage and handling of anhydrous or aqueous ammonia. Equipment deliveries are expected to be completed in the third quarter of 2020. A contract was received for an ULTRA(R) system that will be installed on a natural gas-fired steam boiler in the western United States retrofitted with SCR technology. Fuel Tech's ULTRA process provides for the safe and cost-effective on-site conversion of urea to ammonia for use as a reagent where SCR is used to reduce NOx, eliminating the hazards associated with the transport, storage and handling of anhydrous or aqueous ammonia. This ULTRA system is a permanent system on a unit where a temporary ULTRA rental unit replaced a competing technology. Equipment delivery will be in the first quarter of 2020. In Europe, several change orders to three existing contracts for SCR related systems were also received. Work will be completed in the fourth quarter of 2019.
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RVNC | Hot Stocks16:43 EDT Revance backs FY19 expense guidance - The company states: "Revance reiterates its financial guidance provided in February 2019. Revance expects 2019 GAAP operating expense to be in the range of $173M to $185M and non-GAAP operating expense, which excludes depreciation and stock-based compensation costs, to be in the range of $148 to $158 million as driven by increased research and development expenditures and launch preparation activities. With five clinical programs and preparations to file the BLA underway, Revance anticipates 2019 non-GAAP research and development expense to be $93 to $100 million. With the successful capital infusion through partnering agreements in 2018 and an equity raise in January, management believes the company has adequate cash reserves to fund its current operations through 2020."
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GWGH | Hot Stocks16:42 EDT GWG Holdings expands sales team as it prepares to introduce new products - GWG Holdings announced the hiring of five new executives with experience in the sales and marketing of alternative investments, which expands the Sales and National Accounts Team as the company prepares to introduce additional products early in 2020. The new products will be the direct result of the growing relationship between GWG Holdings and The Beneficient Company Group. While GWG Holdings and Ben announced their intent to form a strategic relationship two years ago, the companies have recently taken important steps to expand their relationship.
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GIFI | Hot Stocks16:40 EDT Gulf Island Fabrication completes strategic review, to remain independent - Gulf Island Fabrication announced the completion of its previously announced review of alternative strategies that began in early May 2019 and was led by a special committee of the board with assistance from the board's financial advisor, Johnson Rice & Company. The review was designed to objectively evaluate alternative strategies for the company, including possible merger or sale transactions, among other things. The review has not resulted in a viable proposal. After careful consideration, the board determined that the interests of the company's shareholders are best served if the company remains independent and the board focuses on executing the company's existing business plan, which includes enhancing the company's resources, processes and procedures to improve competitiveness and overall project execution and consideration of organic and inorganic opportunities for growth.
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DIOD | Hot Stocks16:39 EDT Diodes CEO says well positioned to continue delivering consistent profitability - CEO Keh-Shew Lu says: "Diodes achieved another quarter of record financials, resulting in increased profitability and cash flow from operations. Our nine-month revenue grew 5.4% over the same period last year, while earnings increased over 30%. This growth is especially notable at a time during which our served market was down more than 6.5%. EBITDA also set a new quarterly record and represents the second consecutive quarter to exceed a $300 million annualized run-rate as it approaches 25% of total revenue. Further, gross margin remains solidly above 37% of revenue as product mix continues to benefit from record revenue in the automotive end market as well as our Pericom-branded IC products. Overall, I am very pleased with our year-to-date performance as we carefully navigate the seasonal softness and inventory adjustments that are typical of our industry as we approach year-end. Longer-term, Diodes remains well positioned to continue delivering consistent profitability growth with an ongoing focus on content gains in high-growth areas such as connected cars, high-end servers and storage, 5G as well as IoT."
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LDOS | Hot Stocks16:36 EDT Leidos awarded $60M task order from Centers for Disease Control and Prevention - Leidos has been awarded a new task order by the Centers for Disease Control and Prevention to provide support services for the National Healthcare Safety Network. The single-award, time and materials task order has a one-year base period of performance, followed by four one-year options, and a total approximate value of $60M if all options are exercised. Work will be performed in Atlanta.
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VPG | Hot Stocks16:35 EDT Vishay Precision acquires Dynamic Systems in $41M deal - Vishay Precision announced it acquired New York-based Dynamic Systems Inc., a specialized provider of dynamic thermal-mechanical test and simulation systems used to develop new metal alloys and optimize production processes, for a purchase price of $41 million, subject to customary adjustments, plus a potential earn out of up to an additional $3 million. Commenting on the acquisition, Marc Zandman, Chairman of the Board of VPG said, "We are pleased with the addition of DSI to the VPG platform and the value this transaction creates for our shareholders. Acquiring attractive, profitable businesses is a key element of our capital allocation strategy to create value."
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DXC | Hot Stocks16:34 EDT DXC Technology acquires Bluleader, terms not disclosed - DXC Technology announced it has acquired Bluleader, an Australian consulting company focused on delivering Customer Experience solutions. "We are excited about expanding the reach of Bluleader into DXC's diversified client base, so that our employees are engaged in interesting, challenging and career-enhancing projects," said Robin Apfel, managing director, Bluleader. "This combination will enable us to leverage DXC's market presence, intellectual property and expertise to expand the size and scale of Bluleader as part of DXC Oxygen's Integrated Practice."
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PSTG | Hot Stocks16:34 EDT Pure Storage names Paul Mountford as COO - Pure Storage announced that effective immediately Paul Mountford is joining as the company's COO. Mountford brings 30+ years of senior sales and technology leadership experience, most recently at Riverbed as CEO and previously the Chief Sales Officer. Prior to Riverbed, he was CEO at Sentillian and held senior roles during his tenure at Cisco.
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AAN | Hot Stocks16:32 EDT Aaron's CEO calls Q3 'challenging' - "While the third quarter was challenging, both Progressive and the Aaron's Business accomplished key objectives, which we believe significantly improve our long-term prospects for growth. At Progressive, third quarter invoice growth of 18.6% modestly decelerated from the second quarter. However, we expect increased productivity from new and existing retailers to drive accelerating invoice growth in the fourth quarter. In the Aaron's Business, the team launched new sales and marketing programs, which resulted in the strongest delivery growth the business has experienced in many years but also led to a decline in collections performance as our stores adapted to the new program. Given the positive momentum we are seeing in both businesses, we remain optimistic that we can continue to deliver long-term earnings growth," said John Robinson, CEO.
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AAN | Hot Stocks16:30 EDT Aaron's cuts FY19 adjusted EBITDA view to $425M-$437M from $430M-$452M
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AAN | Hot Stocks16:29 EDT Aaron's lowers FY19 CapEx view to $90M-$100M from $100M-$120M
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PIR | Hot Stocks16:27 EDT Pier 1 Imports names Robert Riesbeck CEO - Pier 1 Importsannounced the appointment of Robert Riesbeck as Chief Executive Officer and as a director of the Company, effective as of the close of business today. Mr. Riesbeck will also continue to serve as Chief Financial Officer. As planned, Cheryl Bachelder, who has served as Interim Chief Executive Officer since December 2018, has stepped down from that role, also effective as of the close of business today, and will continue in her position as a member of Pier 1's Board of Directors.
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RFIL | Hot Stocks16:22 EDT RF Industries acquires Schroff Technologies - RF Industries announced it has acquired Schroff Technologies International, a privately owned Rhode Island-based manufacturer of products serving the high growth wireless, telecom, and cable markets.
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PIR | Hot Stocks16:22 EDT Pier 1 Imports announces NYSE acceptance of continued listing compliance plan - Pier 1 Imports announced that the New York Stock Exchange has accepted the company's business plan to regain compliance with NYSE continued listing standards. As previously disclosed, on August 5, 2019, Pier 1 received notice from the NYSE that it was no longer in compliance with NYSE continued listing standards set forth in Section 802.01B of the NYSE's Listed Company Manual due to the fact that the company's average global market capitalization over a consecutive 30 trading-day period was less than $50 million and, at the same time, its total stockholders' equity was less than $50 million.
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WES | Hot Stocks16:22 EDT Western Midstream sees FY20 CapEx down 20%-30% vs. midpoint of 2019 guidance - For FY20: Adjusted EBITDA is expected to grow approximately 10% year-over-year. Maintenance capital is expected to remain largely consistent as a percentage of Adjusted EBITDA, compared to 2019.
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TRX | Hot Stocks16:20 EDT Tanzanian Gold provides update on Buckreef Project - Tanzanian Gold's board provide shareholders with a guide to the progress that the Buckreef Project has made since the company acquired it. This guide is based on the 43-101 Standard of Reporting. Regulators in Canada require that on any significant matter related to mining, listed companies must follow National Instrument 43-101. Disclosures covered by NI 43-101 include news releases of mineral exploration results, reporting of resources and reserves, technical studies, various levels of feasibility studies, presentations, oral comments, and websites. The company said, "Various authorities have stated that it takes at least 10 years for a mining project to move from exploration to completion of a Final Feasibility Study and Environmental Impact Study, both of which are generally required for government permits, financing and developing comprehensive construction plans. The Company firmly believes that, as illustrated by this guide to NI 43-101, the Buckreef Project has made significant advances. In June 2018, the Company published a comprehensive Pre-Feasibility Study. The authors of this study concluded that the Buckreef Project "is likely to be technically and economically feasible". Highlights of that study, which was done at a gold price of $1,300 per oz are: an after-tax US$ NPV discounted at 5% of $131 million; an IRR of 74%; a capital payback period of 4 years; and an average LOM cash cost of US$ 735 per oz. The Buckreef Project is now one step away from a Final Feasibility Study. Despite the attractive metrics arising from the Pre-Feasibility Study, the Company decided to see if the Buckreef Project can be made bigger and better; and to start to collect the technical data to move the project to the Final Feasibility Stage. To date, the Buckreef Project has; Drilled over 10,000m using at times three drill machines operating 24 hours per day, Developed a geology-resource model of the entire Buckreef Mineralized Zone using technologically advanced data-mine software that will be used for future resource and reserve estimates,Initiated a comprehensive metallurgical review and test data based on a plant that is two times larger than the plant in the Pre-Feasibility Study, and Initiated a rock stress test program to determine the possibility of mining underground below the pit bottom. It is the Company's intention to make a Conceptual Study that incorporates all the new drilling results from the 2019 drill program as well as the data arising from the metallurgical and rock stress tests. This Conceptual Study will most likely be based on a larger open pit than that in the Pre-Feasibility Study and an underground mine that can access resources below the pit bottom. This Study will assist the Company to determine the key parameters of a Final Feasibility Study of the Buckreef Project..."
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MGY | Hot Stocks16:19 EDT Magnolia Oil & Gas sees Q4 production similar to Q3 volume levels - The company said, "We expect our fourth quarter production to be similar as compared to third quarter volume levels. Total capital spending for drilling and completions is expected to decline slightly in the fourth quarter, and in keeping with our business model. As our overall well completions will be weighted more towards Giddings, we expect production in Giddings to increase about 10 percent sequentially during the fourth quarter."
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GNLN | Hot Stocks16:19 EDT Greenlane announces exclusive distribution agreement with Santa Cruz Shredder - Greenlane Holdings announced that it has entered into an exclusive distribution agreement with Santa Cruz Shredder. The agreement became effective on October 1 and grants Greenlane exclusive distribution rights to all Santa Cruz Shredder products and tools.
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ENDP | Hot Stocks16:18 EDT Endo announces CEO Paul Campanelli to retire - Endo announced that Paul Campanelli, President and CEO has notified the Board of Directors of his intention to retire and the Board is implementing its CEO succession plan. Campanelli has been appointed Chairman of the Board effective immediately and will also continue to serve as President and CEO until his successor is appointed. Roger Kimmel, who has served as Chairman of the Board, has been appointed Senior Independent Director. Kimmel replaces Dr. Sharad Mansukani, who is resigning from the Board due to other commitments, including his recent appointment as chairman of the board of another company. The Board is launching a process to identify Campanelli's successor. Campanelli will be actively involved in that process and will help facilitate a smooth transition. In addition, he will continue to serve as Chairman of the Board following the appointment of his successor.
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GEVO | Hot Stocks16:18 EDT Gevo wins bid to supply renewable gasoline to Seattle - Gevo announced it has made the winning bid in a competitive process conducted by the City of Seattle to provide renewable gasoline to its fleet vehicles. Gevo has been awarded a four year contract, with three two-year extensions, to supply at minimum 200,000 gallons/year of renewable isobutanol and 600,000 gallons/year renewable isooctane to the City of Seattle to displace fossil-based gasoline.
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ENSG | Hot Stocks16:16 EDT Ensign Group acquires three skilled nursing facilities in San Antonio, Texas - The Ensign Group, the parent company of the Ensign group of companies, announced that it acquired the real estate and operations of the following skilled nursing facilities in San Antonio, Texas: Hunters Pond Rehabilitation and Healthcare, a skilled nursing facility with 128 skilled nursing beds; Pecan Valley Rehabilitation and Healthcare, a skilled nursing facility with 124 skilled nursing beds; and Westover Hills Rehabilitation and Healthcare, a skilled nursing facility with 124 skilled nursing beds. The acquisitions were effective November 1.
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RYTM | Hot Stocks16:14 EDT Rhythm Pharmaceuticals announces two Phase 3 setmelanotide trials meet endpoints - Rhythm Pharmaceuticals announced additional data from its two pivotal Phase 3 clinical trials evaluating setmelanotide for the treatment of pro-opiomelanocortin, or POMC, deficiency obesity and leptin receptor, or LEPR, deficiency obesity showing the effect of setmelanotide on body mass index, or BMI, scores and certain cardiovascular parameters. These data are being presented by study investigators in a special, late-breaking research forum during the annual meeting of The Obesity Society at ObesityWeek, Rhythm announced that both Phase 3 clinical trials of setmelanotide met their primary endpoints and all key secondary endpoints, demonstrating a statistically significant and clinically meaningful effect on weight loss and reductions in insatiable hunger, or hyperphagia, in patients with POMC deficiency obesity and LEPR deficiency obesity over the course of one year on setmelanotide treatment. Data from both trials also show that when patients withdrew from setmelanotide during a four-week placebo withdrawal period, they experienced rapid increases in weight and hunger. Setmelanotide is a melanocortin-4 receptor, or MC4R, agonist designed to target impairments in the central melanocortin pathway, which is known to regulate weight and hunger. This week's presentations include new data showing the effect of setmelanotide on BMI scores for patients older than 19 and BMI z-scores for patients younger than 19, and its effect on vital signs including diastolic blood pressure, systolic blood pressure and heart rate. Additional analyses of safety data from the Phase 3 trials in POMC deficiency obesity and and LEPR deficiency obesity continue to support that setmelanotide is generally well-tolerated.
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SHAK | Hot Stocks16:14 EDT Shake Shack shares down 12% after earnings report - At time of writing, shares of Shake Shack are down $10.39, or 12.3%, to $73.91.
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PXD | Hot Stocks16:13 EDT Pioneer Natural sees Q4 production 345-360 Mboepd - Fourth quarter 2019 production is forecasted to average between 345 to 360 MBOEPD and 210 to 220 MBOPD. Production costs are expected to average $8.50 per BOE to $10.50 per BOE. DD&A expense is expected to average $13.00 per BOE to $15.00 per BOE. Total exploration and abandonment expense is forecasted to be $10 million to $20 million. G&A expense is expected to be $65 million to $75 million. Interest expense is expected to be $30 million to $35 million. Other expense is forecasted to be $20 million to $30 million. Accretion of discount on asset retirement obligations is expected to be $2 million to $5 million. The Company's effective income tax rate is expected to range from 21% to 25%. Current income taxes are expected to be less than $5 million.
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STRL | Hot Stocks16:12 EDT Sterling sees 'significant boost' to 2020 profitability from Plateau - Sterling Construction said, "In early October, we closed on our acquisition of Plateau, a leading provider of large-scale site infrastructure improvement contracting services that serves primarily large, blue-chip customers in the e-commerce, data center, distribution center and warehousing sectors," remarked Mr. Cutillo. "This acquisition directly aligns with our strategic vision by diversifying Sterling into adjacent end markets with a focus on bottom line growth. Plateau not only positions us in exciting and quickly growing market segments, but also expands our geographic footprint into the highly attractive Southeastern United States. We expect this transaction to result in a significant boost to our profitability in 2020 and beyond and we are excited to ramp up our activities with the Plateau team."
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HTZ | Hot Stocks16:12 EDT Hertz reports Q3 U.S. RAC revenue $2B, up 6% - In Q3: U.S. RAC Transaction Days up 5%, Total RPD up 1%; U.S. RAC Depreciation Per Unit Per Month decreased 5%; Adjusted Corporate EBITDA improved 12%.
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HOLX | Hot Stocks16:11 EDT Hologic launches Definity Cervical Dilator - Hologic has launched the Definity cervical dilator, a "major advancement" for gynecological procedures that uses SureAccess balloon technology to access uterine cavities without a tenaculum, lessening patient discomfort and reducing risk of perforation during dilation. Using SureAccess balloon technology,1 the Definity dilator is designed to eliminate multiple passes and minimize false tracking, reducing injury to the cervix, even in patients with complex or challenging cervical anatomy.
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SHAK | Hot Stocks16:11 EDT Shake Shack sees opening 40-42 new domestic company operated Shacks in FY20 - For the fiscal year ending December 30, 2020, the company see between 40 and 42 new domestic company operated Shacks to be opened and between 20 and 25, net new licensed Shacks to be opened in fiscal 2020.
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ENSG | Hot Stocks16:10 EDT Ensign Group acquires three skilled nursing facilities - The Ensign Group, the parent company of the Ensign group of companies, announced that it acquired the real estate and operations of the following skilled nursing facilities: Treasure Hills Healthcare and Rehabilitation Center, a skilled nursing facility with 110 skilled nursing beds, located in Harlingen, Texas; Keller Oaks Healthcare Center, a skilled nursing facility with 146 skilled nursing beds, located in Keller, Texas; and Kirkwood Manor, a skilled nursing facility with 162 skilled nursing beds, located in New Braunfels, Texas. The acquisitions were effective November 1. Ensign expects these operations to be accretive to earnings in 2020.
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QTS | Hot Stocks16:10 EDT QTS Realty Trust announces expansion of Atlanta-Metro mega data center campus - QTS Realty Trust announced it has commenced an expansion of its Atlanta-Metro mega data center campus. The expansion will include the development of a new data center totaling more than 250,000 square feet of leasable capacity and 72 critical megawatts of incremental power capacity, adjacent to QTS' existing mega data center. The company expects to deliver the first phase of the new development in mid-2020.
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RVNC | Hot Stocks16:09 EDT Revance completes Aspen-1 phase 3 enrollment - Revance announced it has completed patient enrollment of the company's pivotal ASPEN-1 Phase 3 clinical trial for its investigational drug candidate DaxibotulinumtoxinA for Injection, or DAXI, for the treatment of isolated cervical dystonia, a movement disorder affecting the neck. In total, 301 adult patients were enrolled at 60 sites across the U.S., Canada and Europe. Revance plans to announce topline results from the ASPEN-1 Phase 3 trial in the second half of 2020, and is currently enrolling patients in a Phase 2 trial for adult upper limb spasticity and a Phase 2 trial for plantar fasciitis. DAXI is an investigational product and not approved by the FDA.
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XEC | Hot Stocks16:09 EDT Cimarex Energy sees Q4 production volumes 272 - 292 MBOE per day - Fourth quarter 2019 production volumes are expected to average 272 - 292 MBOE per day. Oil volumes are estimated to average 86.0 - 92.0 MBbls per day in the fourth quarter, essentially flat sequentially at the midpoint, with Permian growth expected to outpace total company growth. Total 2019 daily annual oil volumes are estimated to average 84.5 - 86.5 MBbls per day with total production volumes expected to average 274 - 278 MBOE per day, up three percent at the midpoint from previous guidance due primarily to higher than expected NGL recoveries.
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XEC | Hot Stocks16:08 EDT Cimarex Energy cuts FY19 E&D capital guidance view to $1.3B-$1.4B - Estimated 2019 exploration and development investment is $1.30B-1.40B, down four percent at the midpoint from guidance given in February. Midstream investments are estimated to total approximately $70M in 2019.
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ASTE | Hot Stocks16:08 EDT Astec appoints Rebecca Weyenberg CFO - Astec Industries announced that Rebecca Weyenberg will join the company as CFO, effective December 4. In this role, she will lead finance strategy, budgeting and planning, accounting, and financial reporting. Weyenberg succeeds David Silvious, who will be leaving the company at the end of the year to pursue other interests.
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UMRX SGEN | Hot Stocks16:07 EDT Unum Therapeutics shifts focus to ACTR, BOXR product candidates - Unum Therapeutics (UMRX) announced a strategic shift to focus development on its ACTR and BOXR product candidates in solid tumors and supportive platform capabilities. ACTR707 was engineered for properties that optimize its function in solid tumors including increased proliferation, cytokine secretion, and persistence. With Unum's focus on developing therapies for solid tumors, the company will de-prioritize investment in its hematologic programs. Testing through the first four dose levels in the ongoing ATTCK-20-03 Phase 1 trial in non-Hodgkin lymphoma has now established proof-of-concept for ACTR707. Given favorable tolerability to date at relatively low doses, Unum is announcing plans to continue limited dose escalation to inform potential future development of the program in 2020. Separately, Unum and its partner, Seattle Genetics (SGEN) have suspended further dose-escalation of the ATTCK-17-01 Phase 1 trial of ACTR087 with SEA-BCMA in multiple myeloma pending a further review of this program. No dose-limiting toxicities, or DLTs, following ACTR087 administration were reported and no severe adverse events of cytokine release syndrome, or CRS, or neurologic events have been observed to date. Phase 1 ATTCK-34-01 Trial: ACTR707 combined with trastuzumab to treat advanced HER2+ solid tumor cancers. Five clinical sites are now activated to support the Phase 1 trial that is currently enrolling patients. Unum expects to report preliminary safety data from patients treated in the first dose cohort of the trial by the end of this year and to report safety and clinical response data from multiple dose cohorts in 2020. BOXR1030: Incorporating the GOT2 transgene and targeting GPC3+ solid tumor cancers. Unum's first product candidate selected from its Bolt-On Chimeric Receptor, or BOXR, platform, BOXR1030, continues to progress towards first-in-human clinical trials. BOXR1030 expresses a glypican-3, or GPC3, targeted chimeric antigen receptor, or CAR, and leverages the "bolt-on" transgene glutamic-oxaloacetic transaminase 2, or GOT2, to improve T cell function in the solid tumor microenvironment by enhancing T cell metabolism. Preclinical studies have characterized the mechanism of action of BOXR1030's bolt-on transgene with further details to be presented at the upcoming Society for Immunotherapy of Cancer conference during November 6-10, 2019. Based on recent progress, Unum now plans to file an investigational new drug (IND) application for BOXR1030 in late 2020, enabling subsequent clinical testing in GPC3+ cancers. BOXR Platform Expansion: Unum's BOXR platform was established over two years ago with the aim of discovering novel transgenes that can be co-expressed with chimeric-targeting receptors to improve the function of T cells in the solid tumor microenvironment. As part of its strategic shift to target solid tumors, Unum will be scaling up its BOXR platform capabilities with the objectives of: expanding the scope of biological mechanisms and transgenes in its proprietary BOXR library, enabling BOXR bolt-on applications for a broad range of immune cell therapies, including both autologous and allogeneic approaches and advancing new BOXR product candidates into the clinic. Phase 1 ATTCK-20-03 trial: ACTR707 combined with rituximab for relapsed/refractory non-Hodgkin lymphoma. As a preliminary update provided today for the six patients treated in Cohort 4, complete response was achieved at the first response assessment in two of six patients as of the October analysis, yielding a complete response rate of 40% in Cohorts 1 through 4. Of the eight complete responders, four remained in complete response at six months of follow-up, two remain in complete response but have not yet reached the six-month timepoint for evaluation, and two progressed before the six-month timepoint. In Cohorts 1 through 4, ACTR707 was well-tolerated in combination with rituximab. No DLTs, no adverse events of CRS, and no severe neurological adverse events including neurotoxicity have been reported as of the October 2019 cutoff. Further results will be presented at the American Society for Hematology Annual Meeting. Unum plans to enroll up to two additional cohorts (three to four patients per cohort) in the trial, escalating the maximum dose up to 180M ACTR707+ T cells. With patient screening and planned dosing underway, Unum plans to report preliminary results from this dose escalation during 2020. The ability to differentiate on both efficacy and safety relative to currently available therapies and those in development from these additional cohorts will drive a decision during 2020 whether to advance the program into an expanded dose cohort and potential pivotal studies. Phase 1 ATTCK-17-01 trial: ACTR087 combined with SEA-BCMA for relapsed/refractory multiple myeloma. Two additional cohorts of patients have been treated in the Phase 1 trial in 2019, escalating doses of the SEA-BCMA antibody to 2.0 mg/kg and of the ACTR087+ T cells to 50M. Unum and Seattle Genetics have suspended further dose-escalation of the trial and are reviewing the next steps with this program.
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ERII | Hot Stocks16:07 EDT Energy Recovery CEO Chris Gannon resigns, citing personal reasons - Energy Recovery announced the resignation of Chris Gannon as the company's president and CEO and as a member of its board. Gannon submitted his resignation to the board on Friday, November 1, effective immediately, citing personal reasons for his departure. Gannon's resignation was accepted by the Board. The board has appointed Robert Yu Lang Mao as interim President and CEO. Mao currently serves as chairman of Energy Recovery's board, and he will retain his board seat and chairmanship during the transition. Mao will lead the executive search for a permanent replacement for Gannon and will work closely with the company's executive team to provide leadership and ensure continuity until a successor has been appointed.
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WDAY | Hot Stocks16:04 EDT Workday to acquire Scout RFP for $540M in cash - Workday and Scout RFP have signed a definitive agreement under which Workday will acquire Scout RFP in an all cash transaction. Under the terms of the definitive agreement, Workday will acquire Scout RFP for consideration of approximately $540M in cash, subject to adjustments. The transaction is expected to close in Q4 of Workday's fiscal year 2020, ending January 31, 2020, subject to the satisfaction of customary closing conditions, including required regulatory approval.
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QTRX SIEGY | Hot Stocks16:01 EDT Quanterix enters into Neurofilament Light license and supply deal with Siemens - Quanterix (QTRX) announced it has entered into a licensing and supply arrangement with Siemens (SIEGY) Healthineers for access to Quanterix' proprietary Nf-L antibodies, which were recently acquired from UmanDiagnostics. Access to the Nf-L antibodies will allow Siemens Healthineers to begin developing blood-based Nf-L clinical tests for future commercialization. Financial terms were not disclosed.
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DNJR | Hot Stocks15:50 EDT Nasdaq halts Golden Bull Limited for additional information requested - Nasdaq Stock Market announced that trading was halted today in Golden Bull Limited (DNJR) at 15:12:49 p.m. Eastern Time for "additional information requested" from the company at a last sale price of $0.3996. "Trading will remain halted until Golden Bull Limited has fully satisfied Nasdaq's request for additional information," Nasdaq stated.
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LMNX | Hot Stocks15:48 EDT Luminex says it sumitted Verigene II Gastrointestinal Flex Assay to the FDA - Luminex added that it expects to submit the Verigene II Respiratory Flex Assay to the FDA by the end of the year.
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NFLX... | Hot Stocks15:28 EDT TV Time-UTA study sees disparity in consumer awareness for streaming services - A new study called "Beyond the Big Three", was jointly conducted by TV Time and United Talent Agency's IQ data and analytics group this past September to better understand how consumers feel about this new streaming media choices. According to the study there is quire a bit of disparity in the level of consumer awareness of new streaming services coming to market currently. The study says in part: "We know that consumers are cutting the cord at an ever-increasing rate, but what remains unclear is how they feel about the wealth of OTT choices that will soon be available...With so many new entrants, this result suggests the supply of streaming media will soon exceed current consumer demand. As the first of the new services to hit the market, Disney+ (DIS) and Apple TV+ (AAPL) may be less impacted by this dynamic. However, those with launch dates further out may face more of an uphill battle to win new subscribers as they ramp up marketing..., it is not surprising to learn that the vast majority,70%, of respondents feel there will soon be too many streaming video choices...Clearly, there is consumer appetite for both library and original content. However, a lack of library content may put streamers like Apple TV+ at a disadvantage...Disney+ has the highest levels of awareness and intent to subscribe, a healthy mix of library and original content, and the advantage that its service arrives before most others. Other companies in the streaming space include Netflix (NFLX), Dish (DISH), Google's (GOOG, GOOGL), AT&T's (T)HBOYouTube, Comcast (CMCSA), Discovery (DISCA), Amazon.com (AMZN). Reference Link
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PNFP | Hot Stocks14:47 EDT Pinnacle Financial director Richard Callicutt sells over $1.5M in company shares - Pinnacle Financial director Richard Callicutt disclosed in a filing that he had sold 25,000 shares of company stock at an average price o f$60.37 per share between November 1 and November 4. The total transaction value of the sale was $1,509,228.
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PCG | Hot Stocks14:35 EDT PG&E trading resumes
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PCG | Hot Stocks14:29 EDT PG&E trading halted, volatility trading pause
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OMER | Hot Stocks12:08 EDT Omeros sinks after CMS releases final rule on Medicare hospital payments - Shares of Omeros are down 15% in midday trading after the Centers for Medicare & Medicaid Services announced a final rule, with comment period, that revises the Medicare hospital outpatient prospective payment system - OPPS - and the Medicare ambulatory surgical center - ASC - payment system for Calendar Year 2020. As part of its final rule, the CMS stated: "Moreover, the results of a CMS study of cataract procedures performed on Medicare beneficiaries in the OPPS between January 2015 and July 2019 comparing procedures performed with Omidria to procedures performed without Omidria did not demonstrate a significant decrease in fentanyl utilization during the cataract surgeries in the OPPS when Omidria was used. Our results also did not suggest any decrease in opioid utilization post-surgery for procedures involving Omidria. At this time, we do not have compelling evidence to exclude Omidria from packaging after its current pass-through expires on September 30, 2020. We will continue to analyze the evidence and monitor utilization of this drug." Gregory Demopulos, chairman and CEO of Omeros, stated, "Omeros supports CMS' intention and Congress' mandate to remove incentives that lead to increased opioid use, and we are optimistic that CMS will recognize the clear and convincing evidence that packaging OMIDRIA does create such a perverse incentive. OMIDRIA can be readily accessed by veterans as well as commercially insured and Med Advantage patients. We look forward to working with CMS to reduce opioid use and improve patient care by ensuring long-term access to OMIDRIA for Medicare Part B beneficiaries. CMS stated in the final rule that it will continue to analyze the evidence in support of the benefits of OMIDRIA and monitor utilization of this drug, and Omeros intends to address CMS' OMIDRIA-related comments. Omeros also plans to continue its administrative and legislative efforts to secure ongoing separate payment for OMIDRIA beyond the drug's current pass-through extension. OMIDRIA continues to receive separate payment from CMS under its pass-through extension until October 1, 2020." In midday trading, Omeros shares are down $2.50, or 15%, to $13.71. Reference Link
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OMER | Hot Stocks12:08 EDT Omeros sinks after CMS releases final rule on Medicare hospital payments - Shares of Omeros are down xxx% in midday trading after the Centers for Medicare & Medicaid Services announced a final rule, with comment period, that revises the Medicare hospital outpatient prospective payment system - OPPS - and the Medicare ambulatory surgical center - ASC - payment system for Calendar Year 2020. As part of its final rule, the CMS stated: "Moreover, the results of a CMS study of cataract procedures performed on Medicare beneficiaries in the OPPS between January 2015 and July 2019 comparing procedures performed with Omidria to procedures performed without Omidria did not demonstrate a significant decrease in fentanyl utilization during the cataract surgeries in the OPPS when Omidria was used. Our results also did not suggest any decrease in opioid utilization post-surgery for procedures involving Omidria. At this time, we do not have compelling evidence to exclude Omidria from packaging after its current pass-through expires on September 30, 2020. We will continue to analyze the evidence and monitor utilization of this drug." Gregory Demopulos, chairman and CEO of Omeros, stated, "Omeros supports CMS' intention and Congress' mandate to remove incentives that lead to increased opioid use, and we are optimistic that CMS will recognize the clear and convincing evidence that packaging OMIDRIA does create such a perverse incentive. OMIDRIA can be readily accessed by veterans as well as commercially insured and Med Advantage patients. We look forward to working with CMS to reduce opioid use and improve patient care by ensuring long-term access to OMIDRIA for Medicare Part B beneficiaries. CMS stated in the final rule that it will continue to analyze the evidence in support of the benefits of OMIDRIA and monitor utilization of this drug, and Omeros intends to address CMS' OMIDRIA-related comments. Omeros also plans to continue its administrative and legislative efforts to secure ongoing separate payment for OMIDRIA beyond the drug's current pass-through extension. OMIDRIA continues to receive separate payment from CMS under its pass-through extension until October 1, 2020." In midday trading, Omeros shares are down $2.50, or 15%, to $13.71. Reference Link
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UA | Hot Stocks12:01 EDT Under Armour falls -15.1% - Under Armour is down -15.1%, or -$2.86 to $16.05.
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UAA | Hot Stocks12:01 EDT Under Armour falls -16.1% - Under Armour is down -16.1%, or -$3.40 to $17.74.
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NSP | Hot Stocks12:01 EDT Insperity falls -34.0% - Insperity is down -34.0%, or -$36.65 to $71.02.
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VAL | Hot Stocks12:01 EDT Valaris rises 14.2% - Valaris is up 14.2%, or 65c to $5.20.
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SM | Hot Stocks12:01 EDT SM Energy rises 15.3% - SM Energy is up 15.3%, or $1.28 to $9.66.
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SUP | Hot Stocks12:00 EDT Superior Industries rises 24.8% - Superior Industries is up 24.8%, or 66c to $3.32.
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IMRN | Hot Stocks11:31 EDT Immuron receives R&D tax concession refund from Australian government - Immuron Limited announced that under the Australian Government's Research and Development Income Tax Concession incentive program, the company has received a cash refund of A$0.53M for eligible research and development expenditure incurred during the 2019 Financial Year. This refund reflects the company's continual investment made in its research and development programs during the 2019 Financial Year to progress its pipeline programs as well as the continuous development of the company's existing Travelan / Protectyn programs. "We are grateful that the Australian Government is such a strong supporter of the development of early-stage biotechnology companies through the R&D Tax Concession initiative scheme," said Dr. Gary S. Jacob, CEO of Immuron. "This cash refund mechanism provides a non-dilutive way to help with the financing of our in-house programs. Immuron has an ambitious program underway to further the development of our unique hyperimmune bovine colostrum technology directed against gut-specific pathogenic organisms."
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FB | Hot Stocks11:30 EDT Facebook says updating branding, introducing new company logo - Facebook Chief Marketing Officer Antonio Lucio stated in a post to the company's website: "Facebook started as a single app. Now, 15 years later, we offer a suite of products that help people connect to their friends and family, find communities and grow businesses. Today, we're updating our company branding to be clearer about the products that come from Facebook. We're introducing a new company logo and further distinguishing the Facebook company from the Facebook app, which will keep its own branding. The new branding was designed for clarity, and uses custom typography and capitalization to create visual distinction between the company and app. People should know which companies make the products they use. Our main services include the Facebook app, Messenger, Instagram, WhatsApp, Oculus, Workplace, Portal and Calibra. These apps and technologies have shared infrastructure for years and the teams behind them frequently work together...Over the coming weeks, we will start using the new brand within our products and marketing materials, including a new company website." Reference Link
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MCD | Hot Stocks10:42 EDT McDonald's fired CEO Easterbrook can't work for rival for at least two years - In a regulatory filing, McDonald's disclosed details of its separation agreement with Stephen Easterbrook, who was separated from his officer and director positions with the company, as previously reported. The agreement provides that he will be eligible for the severance benefits contemplated by the company's benefit plans upon a termination of employment. "In consideration for such benefits, Easterbrook has agreed to a release of claims in favor of the company, to cooperate with the company following his termination and to various restrictive covenants, including nonsolicitation of employees and non-interference with business partners for two years post-termination and perpetual confidentiality and nondisparagement covenants. In addition, the separation agreement contains a two-year post-termination noncompetition covenant, which is six months longer and more expansive in scope than Mr. Easterbrook's existing noncompetition covenants," the filing stated. "Competitive Companies," as defined by the company's agreement, shall mean any company in the restaurant industry - whether informal eating-out or ready-to-eat - that competes with the business of McDonald's, including examples such as Arby's, BoJangle's, Burger King/Hungry Jacks, Caffe Nero, Checker's, Chick-fil-A, Chipotle, Costa, Culver's, Denny's, Domino's Pizza, Dunkin' Brands, Five Guys, Greggs, Hardee's, In-N-Out Burger, Jack-in-the-Box, Jamba Juice, Long John Silver's Quick Service Restaurant Holdings, Panera Bread, Papa John's, Popeye's Chicken, Potbelly, Q-doba, Quiznos, Seven-Eleven, Sonic, Starbucks, Subway, Tim Horton's, WaWa, Wendy's, YUM Brands, the filing noted.
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SYY | Hot Stocks10:14 EDT Sysco CEO 'feels good about trajectory for 2020' - Comments taken from Q1 earnings conference call.
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ABT | Hot Stocks10:12 EDT Abbott recalls CentriMag System due to pump, motor issues - Abbot is recalling their CentriMag System due to a calibration system error resulting from electromagnetic interference that may cause the pump to slow or stop, the console screen to blank, and various inaccurate alarms. If the pump slows or stops, the patient is at risk of service adverse health consequences such as stroke, severe organ damage or death. Forty-four injuries and one death were reported at the time when Abbot initiated the recall in August 2019, the FDA said in a notice posted on its website. The CentriMag System is intended to pump blood through a patient for up to six hours during open heart procedures. The FDA has identified this as a Class I recall, the most serious type of recall. Reference Link
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TGI ERJ | Hot Stocks10:06 EDT Triumph Group, Embraer collaborate to develop thermoplastic structures - Triumph Group (TGI) and Embraer (ERJ) announced a cooperative agreement to jointly develop and demonstrate the airworthiness of a thermoplastic primary structure in flight. Triumph Aerospace Structures has been developing a thermoplastic elevator assembled using induction welding. The primary detail parts for the elevator structure will be made of unidirectional carbon reinforced thermoplastic material. Embraer will integrate the thermoplastic elevator structure in an aircraft platform and perform in-flight tests to demonstrate the technology readiness. Triumph has made significant investment in thermoplastic technology, and an in-flight testing of the elevator will demonstrate the technology is ready to progress from the lab into production.
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FOCS | Hot Stocks10:03 EDT Focus Financial Partners announces ABG of Michigan to join Sentinel - Focus Financial Partners announced that it has entered into a definitive agreement under which Alliance Benefit Group of Michigan will join Focus partner firm Sentinel Benefits & Financial Group, based in Wakefield, Massachusetts. The transaction is expected to close in the first quarter of 2020, subject to customary closing conditions. Founded in 1969 and located in Bingham Farms, Michigan, ABG of Michigan works with almost 400 benefits and retirement plans representing over 30,000 participants, and provides best-in-class administration and record-keeping services. ABG of Michigan's wholly-owned subsidiary, ABG Portfolio Strategies, Inc., provides investment advisory services primarily for retirement plan assets. ABG of Michigan, will expand Sentinel's geographical reach, creating a premier "super-regional" retirement and benefits-focused financial services firm, and will position Sentinel's business for further growth in the Midwest.
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TRSSF | Hot Stocks09:58 EDT TerrAscend names Ackerman Executive Chairman, President Johnson departs - TerrAscend said it has elected to build a leadership team in New York "with a focus on operational excellence." It announced changes to its board and executive team. New York-based Jason Ackerman, founder and former CEO of online grocer FreshDirect, has been appointed to the company's board and named to the role of Executive Chairman. Effective immediately, Ackerman will oversee day-to-day operations of the company and serve alongside Chairman Jason Wild and CEO Michael Nashat. Heather Molloy has also been promoted to Chief Strategy Officer. Molloy joined the company in May 2018 as EVP Corporate Development. Additionally, President Matthew Johnson has departed the company.
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KOS | Hot Stocks09:47 EDT Kosmos rises 10.0% - Kosmos is up 10.0%, or 64c to $6.96.
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NEXA | Hot Stocks09:47 EDT Nexa Resources rises 12.1% - Nexa Resources is up 12.1%, or $1.04 to $9.60.
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UGAZ | Hot Stocks09:47 EDT VelocityShares 3x Long Natural Gas ETN rises 13.0% - VelocityShares 3x Long Natural Gas ETN is up 13.0%, or $2.22 to $19.26.
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SYPR | Hot Stocks09:46 EDT Sypris awarded long-term supply agreement with Sisamex - Sypris Technologies announced that it has entered into a long-term contract with Sistemas Automotrices De Mexico. Under terms of the agreement, Sypris Technologies will supply components for use in the transmission of a leading global all-terrain and powersports recreational vehicle series. Production begins immediately. Terms of the contract were not disclosed.
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UA UAA | Hot Stocks09:44 EDT Under Armour says sees FY domestic sales 'down slightly' - Says: Moving to playing offense in 2020 vs. defense... Plans to amplify brand in 2020... Sees licensing business up in Q4... "Very happy" with performance in Asia-Pacific region. Kevin Plank says stepping away from CEO position was "my decision."
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PM | Hot Stocks09:36 EDT Philip Morris to end cigarette production in Berlin, take $355M charge - Philip Morris International announced that, as part of its global manufacturing infrastructure optimization, its German affiliate, Philip Morris Manufacturing GmbH reached an agreement with employee representatives to end cigarette production in its factory in Berlin, Germany, by January 1, 2020. In connection with the agreement, Philip Morris expects to record estimated pre-tax charges of approximately $355M. The company expects that most of the pre-tax charges will be recorded in Q4 of 2019 and most of the cash expenditures will occur in 2020. The Berlin factory has a projected 2019 production capacity of approximately 40B units. Approximately 950 employees are impacted under the agreement. Philip Morris Manufacturing GmbH will continue the production of expanded tobacco in Berlin.Cost savings anticipated from the initiative are included in Philip Morris' previously communicated annualized cost efficiencies target of over $1B for the period 2019-2021.
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GE... | Hot Stocks09:28 EDT General Electric teams up with BBAM for AirVault asset transfer system - General Electric Aviation (GE) has teamed up with BBAM Aircraft Leasing & Management to provide the AirVault asset transfer system across a fleet of 510 aircraft including Airbus (EADSY), Boeing (BA) and Embraer (ERJ) airplanes used by more than 90 airlines. The implementation is starting this month. BBAM will start using the system by December, followed by a six-month evaluation. The combination of GE's domain expertise in flight analytics and engine diagnostics to bring disparate data together and the digital leased asset transfer system capability will further enable web-based fleet maintenance across the aviation leasing market. The asset transfer system is a collaborative tool that streamlines and simplifies the way that leased asset documentation is managed between airlines and lessors by allowing operators to organize records in accordance with industry standard. The system enhances the efficiency of lease returns several ways by helping operators harmonize and standardize files, perform collaborative document reviews with their lessor partners, and transfer files through an intuitive digital user interface which includes SPEC 2500 functionality.
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BCML | Hot Stocks09:20 EDT BayCom to acquire Grand Mountain Bancshares for $13.9M - BayCom, the holding company for United Business Bank, and Grand Mountain Bancshares, the holding company for Grand Mountain Bank, FSB, announced the signing of an Agreement and Plan of Merger under which BayCom has agreed to acquire GMB in an all cash transaction valued at approximately $13.9M. Under the terms of the Agreement and Plan of Merger, GMB will be merged with and into BayCom. The agreement also calls for the merger of Grand Mountain Bank with and into United Business Bank. Upon consummation of the merger, each GMB shareholder will receive $3.40 in cash in exchange for each share of GMB common stock. At September 30, 2019, GMB had approximately $130.6 million in assets, $85.6 million in loans, $118.1 million in deposits and $12.2 million in shareholder's equity. The transaction will expand the Company's presence in Colorado. GM Bank serves its communities through its four convenient full-service locations across Grand County and a loan office in Summit County. Upon completion of the transaction, the combined company will have approximately $2.2 billion in total assets, $1.5 billion in total loans and $1.8 billion in total deposits. With this acquisition the United Business Bank will have a total of 36 full service locations, with 17 locations in California, two in Washington, six in New Mexico and 11 in Colorado. The Agreement and Plan of Merger was approved by the boards of directors of BayCom and GMB. The closing of the transaction, which is expected to occur in the first quarter of 2020, is subject to customary conditions, including regulatory approval, and approval by the shareholders of GMB. BayCom anticipates this transaction will be accretive to earnings (before merger costs) in the first year of combined operations and accretive to tangible book value in less than three years.
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HPQ ADBE | Hot Stocks09:18 EDT HP Inc., Adobe announce collaboration for 3D production technology - HP Inc. (HPQ) and Adobe (ADBE) announced Project Captis, a collaboration between HP and Adobe to develop and deliver an end-to-end product that can transform physical materials into digital 3D materials, equipping users with workflow efficiency gains while helping reduce time and costs. Project Captis takes advantage of Z by HP technology and Adobe Substance Alchemist software to take creative workflows to the next level. HP and Adobe plan to deliver Project Captis to partners across various industries, including game development, ecommerce, architecture and fashion, among others. Project Captis kicks off at Adobe MAX and will run through 2020.
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ACST | Hot Stocks09:16 EDT Acasti Pharma partners with Aker BioMarine to supply krill oil for CaPre - Acasti Pharma Inc. announced that it has partnered with Aker BioMarine to deliver krill oil to Acasti, under a two-year, fixed price supply agreement. Raw Krill Oil is the starting material used by Acasti to make CaPre, which is then further processed via a series of complex and proprietary extraction and purification manufacturing steps to produce the drug substance for CaPre. This agreement is intended to ensure an adequate krill oil supply to meet Acasti's anticipated raw material needs through at least mid-2021, including scale-up of production to build future inventory for commercial launch. Furthermore, the parties have agreed to contemplate future commercial collaborations.
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BAC | Hot Stocks09:15 EDT Bank of America to boost minimum hourly rate to $20 from $17 in 2020 - Bank of America announced that it is accelerating the move from its current U.S. minimum hourly rate of pay of $17 to $20 by the end of the first quarter of 2020, more than a year earlier than originally planned. "As part of our commitment to being a great place to work, we are saying thank you, and sharing our success with our teammates who serve our clients and communities every day," said Sheri Bronstein, Chief Human Resources officer at Bank of America.
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BAC | Hot Stocks09:13 EDT Bank of America accelerates move to $20/hour minimum wage in 2020 - Bank of America today announced that it is accelerating the move from its current U.S. minimum hourly rate of pay of $17 to $20 by the end of the first quarter of 2020, more than a year earlier than originally planned. "The decision is part of the company's commitment to delivering sustainable, responsible growth by being a great place to work - through leading physical, financial and emotional benefits as well as innovative learning and development resources that support the needs of its 208,000+ employees. Bank of America is committed to supporting a competitive rate of pay, and has made regular increases to its minimum wage over many years. Since 2010, it has increased by more than $8 per hour."
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AVAV | Hot Stocks09:13 EDT AeroVironment awarded $6.41M Raven follow-on contract - AeroVironment announced it received a firm fixed-price contract valued at $6.41M from an existing Southeast Asian military customer on September 17 for additional Raven unmanned aircraft systems. Delivery is anticipated within 12 months. AeroVironment's Raven system is designed for rapid deployment and high mobility for applications requiring low-altitude intelligence, surveillance and reconnaissance. With a wingspan of 4.5 feet and weighing 4.2 pounds, the hand-launched Raven provides aerial observation, day or night, at line-of-sight ranges up to approximately 6.2 miles. With its stabilized gimbaled payload, the Raven delivers real-time color or infrared imagery to ground control and remote viewing stations.
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LAND | Hot Stocks09:12 EDT Gladstone Land completes acquisition of pistachio orchard in California - Gladstone Land Corporation announced that it has acquired approximately 1,100 gross acres of farmland in Coalinga, California, for $37M. The farm consists of 1,040 planted acres of mature pistachio trees. This was the second and final phase of the purchase of this orchard that includes an eight-year, triple-net lease agreement with RTS Agri Business and Canoas Creek Pistachios. The first phase closed in August for $33M.
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IX | Hot Stocks09:10 EDT ORIX Corp acquires Hunt Real Estate Capital - ORIX Corporation announced that it has signed a definitive agreement to acquire Hunt Real Estate Capital, LLC, a subsidiary of Hunt Companies. "The acquisition combines the financial strength of ORIX USA and the complementary product offerings of ORIX Real Estate Capital brands, Lancaster Pollard and Red Capital Group, with Hunt Real Estate Capital's strong presence in the multifamily industry. Upon closing, 15-year industry veteran James Flynn, Hunt Real Estate Capital's President and Chief Investment Officer, will be the CEO of the combined entity."
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MNKD | Hot Stocks09:09 EDT MannKind receives second $12.5M milestone payment from United Therapeutics - MannKind Corporation announced that it has achieved the second of four specified development milestones under its licensing and collaboration agreement with United Therapeutics for the development and commercialization of a dry powder formulation of treprostinil. Treprostinil Technosphere is an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension. Pursuant to the agreement, MannKind is eligible to earn additional milestone payments up to $25M upon the achievement of other defined development milestones. MannKind will also be entitled to receive low double-digit royalties on net sales of TreT.
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GVP | Hot Stocks09:09 EDT GSE Systems, INL awarded DOE grant to develop solutions for advanced reactors - GSE Systems announced that the U.S. Department of Energy, or DOE, has awarded GSE and Idaho National Laboratory, or INL, a grant to develop dynamic procedures and decision-support solutions for advanced reactors. The grant is aimed towards developing and commercializing a system with the functionality to revolutionize operator and system efficiency, as compared to existing paper-based processes. The new technology aims to address a variety of industry challenges, including barriers to adoption, and the large number of procedures and data architecture required to address advanced reactors that feature increased levels of automation, sensors and instrumentation. By leveraging GSE's highly specialized expertise and technology in control room and plant simulators, software development, and nuclear operations procedures and INL's expertise in human factors, computer-based procedures, and operator decision support, power plant operators will be able to greatly reduce time spent on administrative tasks and increase efficiencies. The system will utilize dynamic procedure decision support for control room operations, emphasizing data analytics and monitoring of plant data, as well as intuitive user interfaces and functionality.
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AKTX | Hot Stocks09:07 EDT Akari Therapeutics expects interim readout from Phase III PNH study in mid 2020 - The company said, "The Company continues to accumulate positive long-term treatment data, which includes over 20 cumulative patient-years of data with no reported drug related serious adverse events. Our ongoing Phase III PNH study in naive patients is expected to have an interim data readout in mid 2020 with the next stage subject to our pen injector program which aims to hold one week's supply of nomacopan stable at room temperature with a daily 0.3ml injection."
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ACAD | Hot Stocks09:07 EDT Acadia appoints Ponni Subbiah CMO - Acadia announced the appointment of Ponni Subbiah as senior VP, global head of medical affairs and CMO. Subbiah will report to Serge Stankovic, Acadia's president and be responsible for corporate medical affairs including medical strategy, scientific communications and medical science liaison activities. Subbiah is a neurologist with over 20 years of experience in the pharmaceutical industry and global health sector. She has led the development and execution of medical and clinical research strategies in various therapeutic areas, including neurology, psychiatry, opioid addiction, pain, oncology, diabetes, urology, inflammation, respiratory and infectious diseases. Subbiah was most recently CMO for Indivior, with responsibility for pharmacovigilance and medical affairs globally.
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GDDY | Hot Stocks09:07 EDT GoDaddy announces strategic partnership with Kabbage - GoDaddy announced its strategic partnership with Kabbage a data and technology company providing small businesses cash flow solutions. Kabbage's online lending platform is now available to GoDaddy's U.S. customers so they can easily access a business line of credit in minutes to manage and grow their businesses. By completing a simple application process from Kabbage, customers can quickly access flexible lines of credit of up to $250,000 in minutes if approved. With increased financial capacity, GoDaddy customers can access the extra cash flow to staff up for the busy holiday season, purchase additional inventory or equipment, apply it toward digital marketing initiatives, or other strategic investments to support their ventures.
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CPE CRZO | Hot Stocks09:06 EDT Callon urges stockholders to vote for acquisition of Carrizo - Callon Petroleum (CPE) issued a statement in response to a report by Institutional Shareholder Services, or ISS, regarding Callon's all-stock acquisition of Carrizo Oil & Gas (CRZO). Statement included: Callon strongly disagrees with ISS's recommendation and believes the following points are essential to understanding the merits of the transaction: Callon's stated strategy remains unchanged: As we have articulated in numerous quarterly investor calls, and on slide 20 of our recently filed investor presentation, Callon has been pursuing four strategic financial objectives: increase cash return on invested capital, generate free cash flow, reduce leverage and maintain a long-term focus. This transaction clearly advances each point of Callon's strategy. Scale is critical in an evolving industry landscape: As the shale industry turns from acreage acquisition to manufacturing mode, the efficiencies gained from large pad development and simultaneous operations are increasingly important for achieving a competitive cost structure.
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AKTX | Hot Stocks09:06 EDT Akari Therapeutics expects data read out of Part B of AKC Phase I/II trial in Q1 - The company said, "Successfully completed Part A of the Phase I/II clinical trial in severe AKC patients who showed a rapid overall improvement of a mean 55% in the composite clinical score. The nomacopan eye drops were found to be comfortable and well tolerated with no reported drug related serious adverse events. Enrollment in the Part B placebo-controlled efficacy arm of the study in 16 patients continues, with a data read out expected in the first quarter of 2020."
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LLY | Hot Stocks09:04 EDT Eli Lilly, Boehringer Ingelheim modernise alliance - Boehringer Ingelheim and Eli Lilly and Company will modernise their current alliance as of 1 January 2020 and focus its combined expertise and investment on the continued development and commercialisation of Jardiance in type 2 diabetes, heart failure, and chronic kidney disease. Trajenta and Basaglar continue to be part of the Alliance, with primary responsibility for development and commercialisation led by the innovator company. Boehringer Ingelheim will continue as strategic lead for Trajenta, and Lilly for Basaglar. Under the amended and restated agreement, there will be a revised margin sharing structure for ongoing payments starting 1 January 2020. There are no changes to Lilly's 2019 financial guidance or 2020 financial goals as a result of this amendment. The specific impact on the upcoming year will be incorporated into Lilly's 2020 guidance, currently scheduled to be issued on 17 December 2019. The net result of the revised margin sharing structure is not expected to be financially material over the duration of the agreement.
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MCD... | Hot Stocks09:04 EDT Fly Intel: Pre-market Movers - HIGHER: Wright Medical (WMGI), up 31% after Stryker (SYK) announced a definitive agreement to acquire all of the issued and outstanding ordinary shares of the company for $30.75 per share, or a total equity value of approximately $4B and a total enterprise value of approximately $5.4B. UP AFTER EARNINGS: Obsidian Energy (OBE), up 9%... Karyopharm (KPTI), up 12%... Bausch Health (BHC), up 2%... Evolus (EOLS), up 7%. DOWN AFTER EARNINGS: Ceragon Networks (CRNT), down 16%... Trevana (TRVN), down 7%. ALSO LOWER: Under Armour (UAA), down 14% after the Wall Street Journal reported both the Justice Department and the Securities and Exchange Commission are investigating the company's accounting practices. Under Armour also reported Q3 results this morning and cut its FY19 revenue growth guidance... McDonald's (MCD), down 2% after firing CEO Steve Easterbrook following the board's determination that "he violated company policy and demonstrated poor judgment involving a recent consensual relationship with an employee"... Aveo Pharmaceuticals (AVEO), down 40% after the FDA said that the company's current interim OS results from the TIVO-3 trial do not abrogate the FDA's concerns over detriment and that those results may worsen with final analysis at 263 events and that the median OS for tivozanib is worse than that of sorafenib... Stryker (SYK), down 3% after announcing the planned acquisition of Wright Medical.
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AKTX | Hot Stocks09:04 EDT Akari Therapeutics exploring pivotal trial designs for nomacopan for BP - The company said, "Phase II trial results with nomacopan were presented at the 28th European Academy of Dermatology and Venereology Congress on October 10, 2019. Four of the six patients were classified as at the upper limit of moderate BP. The four patients saw a rapid and significant improvement in symptoms, with a mean 63% decline in Bullous Pemphigoid Disease Area Index score and mean 68% decline in blister score by day 42, with either no or minimal early steroid treatment. The data showed nomacopan's potential as monotherapy with the additional potential benefit of reducing steroid use which has multiple adverse effects. During the third quarter of 2019, the FDA granted orphan drug designation for nomacopan for the treatment of BP. The company is now exploring pivotal trial designs."
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AKTX | Hot Stocks09:03 EDT Akari Therapeutics expects to start HSCT-TMA pivotal trial in 4Q19 - The company said, "A pivotal trial for HSCT-TMA with nomacopan is expected to start in the fourth quarter of 2019. This devastating condition has an estimated 80% mortality rate in children and has no approved treatments. In August 2019, the FDA granted Fast Track designation to nomacopan for the treatment of HSCT-TMA as well as orphan drug designation for treatment of pediatric patients."
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DAL | Hot Stocks09:01 EDT Delta Air Lines reports October traffic up 5.2%, capacity up 5.1% - Load factor of 85.6% was up 0.1 pts.
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KNDI | Hot Stocks08:58 EDT Kandi Technologies to launch two new EVs in American market - Kandi Technologies Group announced that the Company has newly developed two new mini pure electric vehicle models. The first model is a four-wheeled mini pure EV. The second model is a three-wheeled mini pure EV. These vehicles are intended for use in residential settings to meet U.S. market demand according to DGL Group's market analysis research. After Kandi has undergone several rounds of technical and performance tests on the mini EVs, five of each mini EV model prototypes are completed and ready to be shipped to DGL Group for further tests in the beginning of this month.
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AVGO SYMC | Hot Stocks08:56 EDT Broadcom completes acquisition of Enterprise Security business of Symantec - Broadcom (AVGO) announced that it has completed its acquisition of the Enterprise Security business of Symantec (SYMC). ymantec's Enterprise Security business will now operate as the Symantec Enterprise division of Broadcom and will be led by Art Gilliland as SVP and General Manager. Gilliland most recently served as General Manager of Symantec's Enterprise Security business where he oversaw the Enterprise Security product and engineering teams, Enterprise Security Worldwide Sales and the Enterprise Security customer support organization. He brings more than 20 years of experience in the security software industry.
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ALBO | Hot Stocks08:55 EDT Albireo Pharma appoints Michelle Graham as CHRO - Albireo Pharma announced that Michelle Graham has been appointed Chief Human Resources Officer. She will serve on Albireo's enterprise leadership team, reporting to President and CEO Ron Cooper. Graham comes to Albireo from TESARO, where she served as SVP, CHRO.
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JSDA | Hot Stocks08:52 EDT Jones Soda announces partnership with Harlan Fairbanks - Jones Soda has entered into an agreement with Harlan Fairbanks to distribute Jones fountain and frozen slush products across Canada and select markets in the United States. Beginning in early 2020, Harlan's will offer Jones' signature customized, branded equipment, along with handling the distribution of Jones fountain and frozen slush syrups. In addition to its national footprint across Canada, Harlan's has a strong presence in Alaska and Washington state, which are core markets for Jones' bottle business and its growing fountain business.
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MCF | Hot Stocks08:52 EDT Contango Oil & Gas closes acquisition of assets of White Star Petroleum - Contango Oil & Gas Company has completed its previously announced acquisition of certain assets and liabilities, including approximately 315,000 net acres located in the STACK, Anadarko and Cherokee operating districts in Oklahoma from White Star Petroleum and certain of its affiliates for a total purchase price of $132.5M. Following adjustment for the results of operations for the period between the effective and closing dates, and other estimated customary closing adjustments, the Company paid a total cash consideration of $95.8M which includes the previously funded cash deposit of $12.5M. The acquired White Star assets produced approximately 15,000 barrels of oil equivalent per day as of the July 1, 2019 effective date, and which consisted of approximately 63% oil and NGLs. The acreage is approximately 80% held-by-production. Approximately 65% of the wells are operated by White Star and are mature fields with strong cash flow and that provide significant development potential from PDNP and PUD opportunities. The Properties also include integrated gathering and saltwater disposal systems, which reduces lease operating expenses and adds third party cash flow. The Company also announced today that it has entered into an amendment to its credit agreement by and among the Company, JPMorgan Chase Bank, N.A., as Administrative Agent, pursuant to which two additional banks were added to the bank group, and the borrowing base under the Credit Agreement increased to $145 million. The Acquisition was funded from net proceeds from the previously announced private placement of Series B Contingent Convertible Preferred Stock and borrowings under the Credit Agreement.
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SNCR | Hot Stocks08:50 EDT Indosat Ooredoo selects Synchronoss DXP for user experience - Synchronoss Technologies announced that Indosat Ooredoo has chosen the Synchronoss Digital Experience Platform to deliver a unified, interconnected user experience for customers across all of its engagement channels. The Synchronoss platform will also support Indosat Ooredoo's "future digital economy ecosystem" project, a nationwide initiative to encourage collaboration and develop new ideas, products and use cases involving IoT technology to help drive economic growth.
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SWAV | Hot Stocks08:48 EDT ShockWave Medical announces commercial availability of IVL Catheter - Shockwave Medical announced commercial availability of the Shockwave S4 Peripheral IVL Catheter in select approved geographies. Shockwave S4 is a low-profile catheter specifically designed to access and treat challenging calcified lesions in below-the-knee arteries that are frequently associated with critical limb ischemia, a serious condition associated with significant morbidity and mortality. Many patients with CLI do not respond well to endovascular treatment, especially when calcium is present, often requiring repeat procedures or even limb amputation.
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AGLE GSK | Hot Stocks08:47 EDT Aeglea BioTherapeutics appoints Ravi Rao as CMO, Michael Hanley as CCO - Aeglea BioTherapeutics (AGLE) announced two additions to its senior management team. The Company welcomes Dr. Ravi M. Rao as chief medical officer and Michael C. Hanley as chief commercial officer. Rao joins Aeglea from GlaxoSmithKline (GSK) where he served as Vice President, Global Medical Affairs Head, Immunology and Specialty Franchise, leading programs across a number of emerging disease areas. Hanley was previously Vice President and U.S. Chief Commercial Officer for Esteve Pharmaceuticals.
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UAA UA | Hot Stocks08:45 EDT Under Armour says has clear pipeline of innovation - Says: Gross margin stronger than anticipated... Sees increased marketing spend in 2020... Confident in delivering on long-term plan... Making "incredible progress" in inventory management. Comments taken from Q3 earnings conference call.
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ITMR | Hot Stocks08:45 EDT Itamar Medical announces WatchPAT inclusion in BSC, BCBS FEP policies - Itamar Medical announced that Blue Shield of California and the Blue Cross Blue Shield Federal Employee Plan have included WatchPAT as a covered home sleep apnea diagnostic test. The Company also announced the release of the U.S. Centers for Medicare & Medicaid Services 2020 Fee Schedule which is the second year of a 3-year proposed plan by CMS to reevaluate reimbursement in home sleep apnea diagnostic codes. The changes made in the 2020 Fee Schedule are expected to continue to support and expand the broad use of its WatchPAT technology. In October 2019 both BSC, a health plan that covers approximately 3.7 million lives, and BCBS FEP, a health plan that covers approximately 5.3 million lives, updated their policies to include WatchPAT based on the PAT technology with oximetry and actigraphy, as a covered home sleep apnea diagnostic test. This inclusion of WatchPAT and PAT technology follows an assessment of Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome recently released by Blue Cross Blue Shield Association Evidence Street.
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RNET BP | Hot Stocks08:43 EDT RigNet signs strategic agreement with BP for Intelie Live - RigNet (RNET) announced that it has signed a multi-year agreement with BP (BP). RigNet's Intelie Live will deploy its machine learning based analytics in BP's Remote Collaboration Center, in order to improve operational efficiency and productivity across BP's drilling operations.
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BAM BBU | Hot Stocks08:40 EDT Brookfield closes $9B global private equity fund - Brookfield Asset Management Inc. (BAM) announced the closing of its latest flagship global private equity fund, Brookfield Capital Partners V with total equity commitments of $9 billion in the program. Based on strong investor demand, BCP V attracted total capital commitments exceeding the original $7 billion fundraising target. BCP V's predecessor fund closed in 2016 with $4 billion of total capital commitments. Investors in the Fund are a diverse group of institutional investors, including public and private pension plans, sovereign wealth funds, financial institutions, endowments and foundations, family offices, and private wealth investors. Brookfield Business Partners L.P. (BBU) has committed $3 billion to the Fund, underscoring the alignment of interests with other investors.
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SIBN | Hot Stocks08:37 EDT SI-Bone announces medicare physician payment increase of 27% for SI joint fusion - SI-BONE announced the Centers for Medicare and Medicaid Services has updated the Medicare Physician Fee Schedule for CPT Code 27279, used to report minimally invasive sacroiliac joint fusion procedures, which are commonly performed with the iFuse Implant System. Effective January 1, 2020 the Work Relative Value Units associated with CPT 27279 will increase from 9.03 to 12.13. CMS based its decision in part on comments from surgeons around the U.S., providing extensive evidence that the wRVUs associated for procedures performed from 2015 to 2019 had understated the physician time and work effort required to perform the procedure. As part of this rulemaking, Medicare is finalizing an increase to the CPT code's overall surgeon payment from $720 to $915, an increase of 27%. The Fee Schedule will be updated to reflect this new amount effective January 1, 2020.
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KRYS | Hot Stocks08:36 EDT Krystal Biotech plans on filing INDs on KB104, KB301 in 1H20 - The company said, "We are planning on filing an IND on KB104 for the treatment of Netherton Syndrome and an IND for KB301 in 1H 2020."
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KRYS | Hot Stocks08:35 EDT Krystal Biotech expects interim results from GEM-3 trial in 1H20 - The company said, "In September 2019, we initiated a Phase 1/2, first in-human trial of our second product candidate, KB105, an HSV-1 based gene therapy engineered to deliver a human transglutaminase-1 gene to patients with TGM1-deficient autosomal recessive congenital ichthyosis. TGM1-deficient ARCI is a debilitating rare skin disease characterized by excessive, thick scaling of the skin, causing multiple chronic health conditions. There are approximately 23,000 cases of TGM1-deficient ARCI worldwide and about 400 new cases per year globally. We have dosed two patients in the GEM-3 trial and anticipate announcing interim results in 1H 2020. In October 2019, the FDA granted Fast Track designation to KB105, the company's HSV-1 based gene therapy engineered to deliver a functional human TGM1 gene in patients with TGM1 deficient ARCI. KB105 is currently in a Phase 1/2 clinical study with interim data expected in mid-2020. Fast Track Designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need. The purpose of the Fast Track Designation provision is to help facilitate development and expedite the review and potential approval of drugs to treat serious and life-threatening conditions. Sponsors of drugs that receive Fast Track Designation have the opportunity for more frequent interactions with the FDA review team throughout the development program. These can include meetings to discuss study design, data required to support approval, or other aspects of the clinical program. Additionally, products that have been granted Fast Track Designation may be eligible for priority review of a New Drug Application and the FDA may consider reviewing portions of an NDA before the sponsor submits the complete application. In October 2019, the European Medicines Agency Committee for Orphan Medicinal Product granted orphan drug designation to KB105 for the treatment of TGM1 deficient ARCI. Orphan designation in the EU allows Krystal Biotech to benefit from a number of key incentives, including reduced regulatory fees, protocol assistance, and market exclusivity, to develop a medicine for the treatment of a rare disease affecting not more than five in 10,000 people in the European Union. KB105 was previously granted orphan drug designation by the FDA in August 2018 and is eligible for the pediatric review voucher."
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MPAA | Hot Stocks08:33 EDT Motorcar Parts subsidiary announces strategic partnership with OPAL-RT - Motorcar Parts announced its wholly owned subsidiary D&V Electronics, based in Woodbridge, Ontario, has established a strategic partnership with Montreal, Quebec-based OPAL-RT, combining technologies for electric motor R&D, testing and manufacturing applications. D&V's and OPAL-RT's technologies provide customers the ability to utilize both technologies in combination at any stage of R&D, testing and manufacturing of electric motor inverters used in automotive and other transportation applications, and, specifically, DC powertrains and associated components.
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CURLF | Hot Stocks08:33 EDT Curaleaf Holdings launches first adult-use operations in Massachusetts - Curaleaf Holdings announced the launch of its first Massachusetts adult-use dispensary in Oxford, Massachusetts. The retail store is now open at 425 Main Street in Oxford. In addition to receiving approval on its final license to co-locate the Oxford location by the Massachusetts Cannabis Control Commission on September 13, the company was also granted approval on two provisional licenses to open adult-use retail locations in Ware and Provincetown, Massachusetts. The company was also granted approval on two final licenses for cultivation and manufacturing to be co-located with the current medical cultivation and manufacturing facility in Webster, Massachusetts.
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XFOR | Hot Stocks08:33 EDT X4 Pharmaceuticals appoints Derek Meisner, J.D., as General Counsel - X4 Pharmaceuticals announced the appointment of Derek Meisner, J.D., as General Counsel. Most recently, Meisner held the role of General Counsel at Genocea Biosciences.
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KRYS | Hot Stocks08:33 EDT Krystal Biotech to initiate manufacturing of Phase 3 clinical material in Nov. - The company said, "CMC alignment with the U.S. Food and Drug Administration includes a) support for the proposed commercial manufacturing process, b) the proposed analytical methods and corresponding qualification and validation plans - inclusive of key release assays such as potency, purity and identity and c) the comparability protocol, which helps assess how similar the product derived from our GMP process runs in our Ancoris facility is to the original product used in the Phase 1/2 trial of KB103. Analytical methods are used to assess how reliably and consistently the key product characteristics can be determined in order to ensure patients receive safe and effective product.Following alignment with the FDA on our commercial process and engineering run, we plan to initiate manufacturing of our Phase 3 clinical material at Krystal's Ancoris GMP facility in early November. We anticipate releasing this Phase 3 clinical material in 1Q 2020 and will initiate the B-VEC Phase 3 pivotal trial following release of Phase 3 material. We expect to meet with the FDA before the end of 2019 to finalize trial design and endpoints for the upcoming pivotal trial of B-VEC. Earlier this year B-VEC received RMAT designation from the FDA and PRIME eligibility from the EMA."
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NSP | Hot Stocks08:32 EDT Insperity trading resumes
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PEGI | Hot Stocks08:30 EDT Pattern Energy trading resumes
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CBAY | Hot Stocks08:30 EDT CymaBay reaches target enrollment in ENHANCE global Phase 3 study - CymaBay Therapeutics announced achievement of the targeted 240 patient enrollment goal for ENHANCE, a global Phase 3 study evaluating seladelpar for patients with Primary Biliary Cholangitis. CymaBay is on track to complete full enrollment by the end of November. With more than 240 patients enrolled, ENHANCE is CymaBay's lead regulatory registration study evaluating the safety and efficacy of its investigational drug, seladelpar, for patients already diagnosed with PBC who have been using ursodeoxycholic acid, but have not achieved the recommended treatment goal or cannot tolerate UDCA. ENHANCE is a 52-week, placebo-controlled, randomized study conducted in over 20 countries.
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PGNX LNTH | Hot Stocks08:30 EDT Progenics urges shareholders to revoke any consents delivered to Velan Capital - Progenics Pharmaceuticals (PGNX) issued the following letter that it intends to mail to shareholders, urging shareholders to revoke any consents previously delivered to Velan Capital L.P. by signing and returning Progenics' WHITE Consent Revocation Card. The letter read in part: "Velan Capital, L.P. is attempting to take control of Progenics by replacing five of the seven directors on the Board of Directors through a consent solicitation campaign. Your choice in this matter will determine the future value of your investment. Your Board has heard the call for change and has carefully evaluated the Company's challenges with a clear and open-mind. To address these challenges, your Board determined that combining with Lantheus (LNTH) is the best path forward for the Company and maximizes value for you, our shareholders. Even though they haven't yet had a chance to fully evaluate the Lantheus transaction, the Velan nominees say they have a better idea. But you should be very skeptical of their untested "plan to build a plan" - which we believe could lead to considerable risk and uncertainty...Make no mistake: if you give Velan control of the Progenics Board, they won't just re-examine the transaction, they will do everything they can to undermine it. Don't let Velan rob you of your right to a true and fully informed opportunity to vote on the compelling Lantheus transaction and maximize the value of your investment...Shareholders deserve the right to make a fully informed decision with key information on the process and prospects of the Lantheus transaction."
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MKTX | Hot Stocks08:22 EDT MarketAxess completes acquisition of LiquidityEdge - MarketAxess Holdings has completed its previously announced acquisition of LiquidityEdge, a leading provider of an electronic U.S. Treasuries marketplace. The acquisition was completed on November 1, 2019 following approval from the necessary regulatory authorities. The purchase price is approximately $150 million, including $100 million in cash and 146,450 shares of MarketAxess common stock, subject to customary purchase price adjustments.
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S | Hot Stocks08:21 EDT Sprint says postpaid gross additions in digital channels up over 40% y/y - In Q2, Sprint continued to enhance its digital capabilities and transform the way it engages with customers. Postpaid gross additions in digital channels increased more than 40% year-over-year. Approximately one of every five postpaid upgrades occurred in digital channels. More than 30% of all Sprint customer care web chats are performed by virtual agents using artificial intelligence. The company continued to launch voice-to-digital tools that allow customers calling with specific issues to use a digital self-service option. Web conversions improved and year-to-date orders from digital media more than doubled compared to the same time period last year.
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FOMX | Hot Stocks08:21 EDT Foamix announces publication of AMZEEQ topical foam long-term safety data - Foamix Pharmaceuticals announced the peer review publication of the long term open label safety portions of studies FX2014-04 and FX2014-05 in the Journal of Clinical and Aesthetic Dermatology. Studies 04 and 05 were conducted by Foamix to support the New Drug Application submission of AMZEEQ topical foam, which was approved by the U.S. Food and Drug Administration for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Highlights from the Long-Term Safety Program: The open-label safety portions of Studies 04 and 05 enrolled a total of 657 patients, all of whom had completed 12 weeks of AMZEEQ topical foam, 4% or vehicle treatment in the preceding double-blind phases of these studies. Patients continued for up to an additional 40 weeks of open-label treatment with AMZEEQ. Of those enrolled in this safety study, 291 completed a total of 52 weeks of therapy. The key findings from the study are as follows: Subject satisfaction with AMZEEQ treatment remained high when re-assessed at Week 52 which was consistent with scores obtained at Week 12. Application site adverse events occurred in less than 2% of patients during the additional 40 weeks of open-label treatment with AMZEEQ. In the assessment of facial dermal tolerability at Week 52, more than 95% of patients had "none" or "mild" signs and symptoms, and no severe local tolerability scores were recorded. Non-dermal adverse events were comparable in type and frequency with those reported during the double-blinded portions of each study. The most frequently reported treatment-emergent adverse event was nasopharyngitis. No serious drug-related adverse events were reported.
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RVNC | Hot Stocks08:20 EDT Revance announces publication of SAKURA 1, SAKURA 2 results - Revance Therapeutics announced the publication of results from the Phase 3 studies, SAKURA 1 and SAKURA 2, in Plastic and Reconstructive Surgery, or PRS, the peer reviewed Journal of the American Society of Plastic Surgeons. These two Phase 3 studies evaluated Revance's long-acting neuromodulator product, DaxibotulinumtoxinA for Injection, or DAXI, for the treatment of moderate and severe glabellar lines. This manuscript presents the findings from SAKURA 1 and 2 side-by-side, which demonstrate the consistency of efficacy and safety results evident between the two pivotal studies, as well as the reproducibility of these outcomes with DAXI across patients and clinical trial sites. Both SAKURA 1 and SAKURA 2 demonstrated that half of the patients treated maintained none or only mild frown lines for at least 24 weeks, after a single treatment. Additionally, frown lines did not return to their pre-treatment severity for at least 26-28 weeks for half of the patients treated. "The publication in PRS highlights the quality of the Phase 3 clinical data and underscores how DAXI unlocks the true potential for a next generation neuromodulator product," said Mark Foley, President and CEO of Revance Therapeutics.
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CNHI | Hot Stocks08:19 EDT CNH Industrial acquires K-Line Ag, terms not disclosed - CNH Industrial announced its agreement to acquire the Australian agricultural implement manufacturer K-Line Ag. This acquisition will add key tillage and residue management equipment, which is key to ensuring optimal seedbed preparation, fundamental for productive yields, and will further enhance the crop production portfolios of Case IH and New Holland Agriculture, the global agricultural equipment brands of CNH Industrial. K-Line has become the number one tillage manufacturer in Australia by designing robust and reliable products for some of the world's harshest soil conditions.
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AUDC | Hot Stocks08:18 EDT AudioCodes announces collaboration with NEC - AudioCodes announced that it is collaborating with NEC Corporation to offer a comprehensive voice and data layer network monitoring and analytics solution. The joint solution is facilitated through integration of the AudioCodes One Voice Operations Center, or OVOC, and NEC's MasterScope and is designed to help enterprises, contact centers and service providers simplify voice network operations, improve user experience and reduce downtime. Both companies will sell the joint solution to customers around the world.
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GBT | Hot Stocks08:18 EDT Global Blood Therapeutics announces new employment inducement grants - Global Blood Therapeutics announced that on November 1, 2019, the compensation committee of GBT's board of directors granted 72 new employees options to purchase an aggregate of 55,100 shares of the company's common stock with a per share exercise price of $49.72 and restricted stock units for an aggregate of 144,600 shares of the company's common stock. All of the above-described awards were made under GBT's Amended and Restated 2017 Inducement Equity Plan (the Plan).
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CEMI | Hot Stocks08:17 EDT Chembio Diagnostics receives WHO Prequalification approval for HIV self-test - Chembio Diagnostics announced its SURE CHECK HIV Self-Test has received World Health Organization Prequalification approval. The WHO Prequalification of In Vitro Diagnostics is a comprehensive assessment of individual IVDs through a standardized process that includes inspection of the manufacturing site, review of a product dossier, performance evaluation including operational characteristics, and labelling review. It signifies that the product meets global standards of quality, safety and performance, and is used by United Nations and other procurement agencies such as PEPFAR, UNITAID, and the Global Fund to make purchasing decisions. The SURE CHECK HIV Self-Test provides unparalleled ease of use -- using the world's smallest blood sample required by any rapid HIV test -- and provides results in 15 minutes. The unique design of the SURE CHECK HIV Self-Test integrates the capillary device and buffer solution, eliminating the need for separate collection devices and buffer solution bottles required by other HIV self-tests. The SURE CHECK HIV Self-Test, which detects antibodies to HIV 1 and HIV 2, demonstrated sensitivity of 99.4% and specificity of 100%, when comparing untrained HIV self-test users to trained professionals. The essential element of Chembio's newly WHO Prequalified HIV Self-Test is the company's SURE CHECK HIV 1/2 Assay that is FDA approved, CLIA waived, CE marked, WHO Prequalified, and trusted by health care professionals across the globe. Chembio's SURE CHECK HIV 1/2 Assay was also incorporated into two CE marked private label versions of HIV self-tests that both commenced European commercialization in 2015. In 2016, the WHO published global HIV self-testing guidelines, recommending that HIV self-testing be offered as an additional approach to HIV testing services. Chembio's SURE CHECK HIV Self-Test was evaluated by the HIV Self-Testing Africa Initiative that is funded by UNITAID, with the goal of accelerating self-test adoption by addressing market, regulatory and policy barriers. SURE CHECK HIV Self-Test was found to have superior acceptability and performance, facilitating widespread adoption.
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XRF | Hot Stocks08:15 EDT China Rapid receives NYSE's approval for its Business Transformation Plan - China Rapid Finance announced receipt of a letter from the NYSE accepting the Business Transformation Plan submitted by XRF on September 13. The Plan lays out a roadmap for addressing and achieving the NYSE's continued listing criteria. The Company believes its Plan offers a reasonable and achievable path toward restructuring its business and eventually resuming robust growth, serving the emerging consumer credit market in China. As part of the Plan, XRF intends to file Form 20-F for the fiscal year ended December 31, 2018, on or before November 15.
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FOMX | Hot Stocks08:14 EDT Foamix announces peer review publication on studies FX2014-04 and FX2014-05 - Foamix Pharmaceuticals announced the peer review publication of the long term open label safety portions of studies FX2014-04 and FX2014-05 in the Journal of Clinical and Aesthetic Dermatology, or JCAD. Studies 04 and 05 were conducted by Foamix to support the New Drug Application submission of AMZEEQTM topical foam, which was approved by the U.S. FDA for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. The open-label safety portions of Studies 04 and 05 enrolled a total of 657 patients, all of whom had completed 12 weeks of AMZEEQ topical foam, 4% or vehicle treatment in the preceding double-blind phases of these studies. Patients continued for up to an additional 40 weeks of open-label treatment with AMZEEQ. Of those enrolled in this safety study, 291 completed a total of 52 weeks of therapy. Subject satisfaction with AMZEEQ treatment remained high when re-assessed at Week 52 which was consistent with scores obtained at Week 12.
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S TMUS | Hot Stocks08:13 EDT Sprint CEO says merging with T-Mobile 'best outcome for all consumers' - "I am proud of the resiliency of the Sprint team as they work to deliver results in a challenging environment," said Sprint CEO Michel Combes. "However, I remain convinced that merging with T-Mobile and building one of the world's most advanced 5G networks is the best outcome for all consumers, employees, and shareholders."
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UPS | Hot Stocks08:13 EDT UPS forecasts holiday returns will peak at 1.9M on January 2 - This holiday season UPS is forecasting yet another record-breaking year for e-commerce returns - illustrating how e-commerce is continuing to change the way people shop for the holidays. In December, consumers will ship via UPS more than 1 million return packages back to retailers daily, a pace that is expected to last into early January. An initial spike in returns is expected the week before Christmas, with 1.6 million packages being returned each day the week of Dec. 16. This first spike will likely be driven by retailer promotions, which will prompt shoppers to buy gifts early - both for their loved ones and for themselves. The second and largest spike in returns, which UPS dubs "National Returns Day," is expected to occur on Jan. 2 with a whopping 1.9 million packages returned through the UPS network - a 26 percent increase from last year's peak returns day.
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RUBY HURN | Hot Stocks08:12 EDT Entrada Therapeutics appoints Nathan Dowden as COO - Entrada Therapeutics announced the appointment of Nathan J. Dowden as COO. Dowden was most recently Senior Vice President of Strategy and Corporate Development at Rubius (RUBY) Therapeutics and joins Entrada with almost 30 years of strategy, investment and operational experience in the healthcare field. While serving as Senior Vice President of Strategy and Corporate Development at Rubius, Dowden worked to develop and integrate the company's platform, capital formation and communication strategy to support the organization's evolution from an early discovery company into a clinical development organization. Prior to joining Rubius, Dowden served as Managing Director at the Huron Consulting Group (HURN).
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S TMUS | Hot Stocks08:11 EDT Sprint reports continued execution of Next-Gen Network plan - Sprint (S) made continued progress on executing its Next-Gen Network plan. Sprint has 2.5 GHz spectrum deployed on approximately 85% of its macro sites. Sprint has approximately 35,000 outdoor small cells deployed including both mini macros and strand mounts. Sprint has continued the rollout of Massive MIMO, a breakthrough technology that improves network capacity, enhances LTE performance, and allows for simultaneous use of spectrum for LTE and 5G. The company has thousands of Massive MIMO sites on-air across the country. Sprint completed the initial launch of its True Mobile 5G network and recently announced that the service now covers approximately 16M people within nine metropolitan areas - Atlanta, Chicago, Dallas-Fort Worth, Houston, Kansas City, Los Angeles, New York City, Phoenix and Washington, D.C. In these areas, customers with 5G devices are experiencing dramatically faster speeds, with initial 5G performance results showing a nearly 6X increase in average download speed compared to Sprint LTE. The company is offering 5G capable smartphones from LG, Samsung, and OnePlus, along with a hotspot device from HTC. Sprint continues to advocate for its merger with T-Mobile (TMUS) to deploy a ubiquitous, nationwide 5G network that includes coverage in rural locations. Sprint's existing 5G deployment shows the potential of 5G, and the combined company is expected to have the resources and technology to bring that potential to reality by building a 5G network that fuels innovation across every industry, dramatically increasing competition, unleashing new economic growth, and creating thousands of jobs and billions of dollars in U.S. economic value. Together, the combined company is expected to lead the world in next-generation technology services and applications, bringing 5G service to nearly all Americans.
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NSP | Hot Stocks08:11 EDT Insperity trading halted, news pending
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MANT | Hot Stocks08:11 EDT ManTech appoints Daniel Payne as chief security officer - ManTech announced that it has named Daniel Payne as Senior Vice President and Chief Security Officer, reporting to President and CEO Kevin M. Phillips. In this role, Payne will lead all aspects of security, including physical, personnel, insider threat, digital, and program security. He will ensure compliance with industrial, information, and operational security regulations and prepare ManTech to address emerging threats. Payne joins ManTech from the DoD's Defense Counterintelligence and Security Agency, where as Director he transformed security with an innovative risk-based methodology, fed by intelligence and tailored to support facilities and diverse technologies across 13,000 locations.
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PGNX | Hot Stocks08:10 EDT Glass Lewis recommends stockholders vote for Velan Capital board nominees - Velan Capital, one of the largest stockholders of Progenics, announced that proxy advisory firm Glass Lewis has recommended that stockholders vote on the Green consent card in support of Velan's director nominees, Gerard Ber, Eric Ende, Heinz Mausli and David Mims, to constitute a majority of the Progenics board. Glass Lewis also recommended the removal of CEO Mark Baker and David Scheinberg from the board. Institutional Shareholder Services, or ISS, also recently recommended stockholders support Velan's case for change by voting on the Green consent card in support of its director nominees. Additionally, the third proxy advisory firm, Egan-Jones, has recommended that stockholders vote for all Velan nominees on the Green consent card. Bala Venkataraman, managing partner of Velan Capital, issued the following statement: "We are pleased Glass Lewis agrees with us that a majority of the Progenics Board must be refreshed. In our view, a clear mandate for change now exists - with all three proxy advisory firms, including Glass Lewis, ISS and Egan Jones, supporting our case for change at the Company..."
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BKYI | Hot Stocks08:10 EDT BIO-key adds Technology Transfer Institute of Africa to Channel Alliance Program - BIO-key International announced that the company has added Technology Transfer Institute of Africa as a Channel Alliance Partner. The CAP program is designed for Managed Service Providers, Security Integrators, and value-added resellers who specialize in providing security solutions to their customers. The CAP program, announced in September, enables partners to represent BIO-key's complete line of biometric authentication solutions from our large scale identity management products to BIO-key's ID Director for Windows which operates with Microsoft Active Directory to deliver biometric Single Sign-on or Multi-factor authentication across the organization. The suite of partner solutions also includes ID Director for SAML and BIO-key's complete line of compact fingerprint scanners that have been tested and qualified by Microsoft to support Windows Hello and Windows 10.
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PVAC XOG | Hot Stocks08:08 EDT Penn Virginia appoints Russell Kelley Jr. as CFO - Penn Virginia Corporation (PVAC) announced that Russell T. Kelley, Jr. has been named Senior Vice President, Chief Financial Officer and Treasurer effective November 13, 2019. Kelley previously served as Chief Financial Officer of Extraction Oil & Gas, Inc. (XOG).
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PEGI | Hot Stocks08:07 EDT Pattern Energy reaffirms FY20 cash available for distribution view $185M-$225M - Pattern Energy is re-confirmed its targeted annual cash available for distribution for 2019 within a range of $160M-$190M.
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MT | Hot Stocks08:06 EDT AM InvestCo Italy sends termination notice on purchase agreement for Ilva - AM InvestCo Italy sent to Ilva's Commissioners a notice to withdraw from, or terminate, the agreement for the lease and subsequent conditional purchase of the business of Ilva S.p.A. and certain of its subsidiaries, closed on 31 October 2018. The Agreement stipulates that, in the event that a new law affects the environmental plan for the Taranto plant so as to materially impair the ability to operate it or to implement its industrial plan, the Company has a contractual right to withdraw from the Agreement. Effective on 3 November 2019, the Italian Parliament has removed the legal protection necessary for the Company to implement its environmental plan without the risk of criminal liability, thus justifying the withdrawal notice. In addition, the decisions issued by the criminal court of Taranto bind the Ilva extraordinary Commissioners to complete certain prescriptions by 13 December 2019 - a term the Commissioners themselves deemed impossible to meet - failing which blast furnace number 2 will be shut down. Such prescriptions should also reasonably and prudentially be applied to the other two blast furnaces at the Taranto plant. The shutdown would make it impossible for the Company to implement its industrial plan, operate the Taranto plant and, generally, perform the Agreement. Other serious occurrences, independent of the Company's will, have also led to a situation of legal and operational uncertainty that has further significantly impaired the ability to carry out the necessary operations at Ilva and operate the Taranto plant. All the mentioned circumstances also entitle the Company to terminate the Agreement under the applicable provisions and principles of the Italian Civil Code. In accordance with the content of the Agreement, the Company has asked the extraordinary Commissioners to take responsibility for Ilva's operations and employees within 30 days from the receipt of the notice of withdrawal and termination.
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S | Hot Stocks08:06 EDT Sprint reports Q2 wireless service revenue $5B - Postpaid wireless service revenue of $4.2B was stable sequentially and year-over-year. Postpaid average revenue per account of $124.81 and postpaid phone average revenue per user of $50.10 were stable sequentially and year-over-year.
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EROS | Hot Stocks08:06 EDT Eros acquires international distribution rights to 4 Bollywood films - Eros International announced that it will release four Hindi language films across different genres later this year in several overseas markets including the UK, US and Middle East. "First to release will be the romantic action film titled 'Marjaavaan' on the 15th of November, directed by Milap Zaveri, starring Sidharth Malhotra, Riteish Deshmukh, Tara Sutaria and Rakul Preet Singh. Produced by T-Series and Emmay Entertainment, the film is a dramatic, violent and action-packed love story. The second film to be distributed will be 'Pagalpanti', which is scheduled to release on the 22nd of November. The forthcoming film is a comedy caper directed by filmmaker Anees Bazmee and produced by T-Series and Panorama Studios. The story of the film revolves around a group of Indian tourists on vacation that turns into a patriotic mission. The comedy stars Anil Kapoor, John Abraham, Ileana D'Cruz and Arshad Warsi. Closely followed will be two other releases, one titled 'Pati Patni Aur Woh' and the other, 'The Body'. The two starkly different films are scheduled to release simultaneously on the 6th of December. The former is a remake of a cult Bollywood film of the same name. Produced by T-Series and directed by Mudassar Aziz, the highly awaited film stars Kartik Aaryan, Ananya Panday and Bhumi Pednekar. 'The Body' is a thriller mystery inspired by its Spanish antecedent. Produced by Viacom18 Motion Pictures, the film is headlined by Emraan Hashmi, Rishi Kapoor, Vedhika and Sobhita Dhulipala."
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S | Hot Stocks08:05 EDT Sprint reports Q2 adjusted EBITDA $2.6B
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PHR | Hot Stocks08:04 EDT Phreesia appoints Randy Rasmussen as Chief Accounting Officer - Phreesia (PHR) announced the appointment of Randy Rasmussen as Chief Accounting Officer, reporting to Tom Altier, Phreesia's CFO, effective November 1. Most recently, he was a Senior Vice President and Controller with Medidata Solutions (MDSO).
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PEGI | Hot Stocks08:04 EDT Pattern Energy to be acquired by CPPIB for $26.75 per share in cash - Pattern Energy Group announced a definitive agreement, pursuant to which Canada Pension Plan Investment Board, or CPPIB, will acquire Pattern Energy in an all-cash transaction for $26.75 per share, implying an enterprise value of approximately $6.1B, including net debt. CPPIB and Riverstone Holdings have concurrently entered into an agreement pursuant to which, at or following the completion of the proposed acquisition of Pattern Energy by CPPIB, CPPIB and Riverstone will combine Pattern Energy and Pattern Energy Group Holdings 2 LP under common ownership, bringing together the operating assets of Pattern Energy with "the world class development projects and capabilities" of Pattern Development. Under the terms of the merger agreement, Pattern Energy shareholders will receive $26.75 in cash consideration for each share of Pattern Energy, representing a premium of approximately 14.8% to Pattern Energy's closing share price on August 9, 2019, the last trading day prior to market rumors regarding a potential acquisition of the company. The consideration also represents a 15.1% premium to the 30-day volume weighted average price prior to that date. The Pattern Energy management team, led by Mike Garland, will lead the combined enterprise. The transaction is expected to close by the second quarter of 2020, subject to Pattern Energy shareholder approval, receipt of the required regulatory approvals, and other customary closing conditions. The Pattern Energy transaction is not contingent upon the completion of the Pattern Development transaction. Upon the completion of the transaction, Pattern Energy will become a privately held company and shares of Pattern Energy's common stock will no longer be listed on any public market. Pattern Energy will continue paying its quarterly dividend through the transaction close.
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S | Hot Stocks08:04 EDT Sprint reports Q2 postpaid net additions of 273,000 - Reports Q2 data device net additions of 364,000 were partially offset by phone net losses of 91,000. Average postpaid accounts were stable sequentially and year-over-year for the second consecutive quarter.
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CLSN | Hot Stocks08:03 EDT Celsion says iDMC recommends continuation of Phase III OPTIMA study - Celsion Corporation announced that the independent Data Monitoring Committee has unanimously recommended the OPTIMA Study continue according to protocol. The recommendation was based on a review of blinded safety and data integrity from 556 patients enrolled in the Company's multinational, double-blind, placebo-controlled pivotal Phase III study with ThermoDox plus RFA in patients with hepatocellular carcinoma, or primary liver cancer. The iDMC pre-planned interim efficacy review followed 128 patient events, or deaths, which occurred in August 2019. Data presented demonstrated that PFS and OS data appear to be tracking with patient data observed at a similar point in the Company's subgroup of patients followed prospectively in the earlier Phase III HEAT Study, upon which the OPTIMA Study is based. The data review demonstrated the following: The OPTIMA Study patient demographics and risk factors are consistent with what the Company observed in the HEAT Study subgroup with all data quality metrics meeting expectations. Median PFS for the OPTIMA Study reached 17.3 months as of August 2019. These blinded data compare favorably with 16.8 months median PFS for the 285 patients in the HEAT Study subgroup of patients treated with RFA greater than 45 minutes and followed prospectively for overall survival. At this time point, combined Overall Survival for both treatment arms is consistent with that observed in the 285 patient prospective HEAT Study subgroup. The OPTIMA Study has lost only 4 patients to follow-up from the initiation of the trial in September 2014 through August 2019; the trial design allows for 3% loss per year. The iDMC reviews study data at regular intervals, with the primary responsibilities of ensuring the safety of all patients enrolled in the study, the quality of the data collected and the continued scientific validity of the study design.
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PEGI | Hot Stocks08:03 EDT Pattern Energy to be acquired by CPPIB for $26.75 per share in cash
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NERV | Hot Stocks08:00 EDT Minerva expects seltorexant findings to help define Phase 3 clinical program - The company said, "During 2019, the Company completed and announced top-line results from three Phase 2b trials and one Phase 1b trial with seltorexant. Three of these trials were in MDD and one was in insomnia disorder. Key conclusions following data analyses from these trials include the following. Seltorexant shows clinically meaningful and consistent improvements in mood and sleep symptoms. In depressed patients, seltorexant shows improvement in mood as monotherapy and as add-on therapy to SSRIs or SNRIs, and its effect on mood is stronger in patients with insomnia. Among the doses of seltorexant tested, 20 mg shows the most robust and consistent effect on mood. In both adult and elderly subjects, seltorexant improves both sleep induction and sleep maintenance compared to zolpidem. Seltorexant shows a safety and tolerability profile similar to placebo. These findings are expected to help define a Phase 3 clinical development program for seltorexant that potentially will encompass both MDD and insomnia."
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NERV | Hot Stocks07:58 EDT Minerva expects top-line results for Phase 2b trial of MIN-117 in Q4 - The company said, "Enrollment has been completed in a Phase 2b trial of MIN-117 in the U.S. and Europe, with a total of 360 adult patients enrolled with moderate or severe major depressive disorder with anxious distress and without psychotic features. The Company expects top-line results from this trial in the fourth quarter of 2019. This trial is a 6-week, 3-arm, randomized, double-blind, placebo-controlled study to investigate the safety and efficacy of MIN-117. The primary efficacy endpoint is the change in the Montgomery-Asberg Depression Rating Scale total score from baseline to the end of the double-blind treatment period, and the key secondary endpoint is the change in the Hamilton-Anxiety Rating Scale over the same period."
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OMER | Hot Stocks07:58 EDT Omeros publishes results showing Omidria reduces fetanyl use in cataract surgery - Omeros announced that results of a prospective, controlled study showing that its FDA-approved ophthalmic drug Omidria reduces use of the opioid fentanyl during cataract surgery while also reducing surgical pain were published in the peer-reviewed journal Clinical Ophthalmology. Omidria is approved by FDA for prevention of miosis and for reduction in postoperative pain for adults and pediatric patients undergoing cataract or lens replacement surgery. The study objectives were to evaluate the effect of Omidria compared to epinephrine on perioperative fentanyl use and pain in patients undergoing cataract surgery. Sixty patients were prospectively assigned to have either Omidria or epinephrine added to the irrigation solution used during surgery. Patients in the Omidria group were 6.7 times more likely not to require fentanyl, with 9.8% of Omidria patients requiring fentanyl versus 42.1% of epinephrine patients. In addition, mean visual analog scale pain scores were significantly lower in the Omidria group than in the epinephrine group. The proportion of patients with VAS scores of 3 was significantly greater in the Omidria group than in the epinephrine group. Omidria patients also were 94% less likely to require fentanyl or to have moderate-to-severe pain than patients receiving epinephrine. Congress and CMS understand the public health risk associated with opioid exposure and CMS is required under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment, or SUPPORT, for Patients and Communities Act to review payments under its outpatient prospective payment system for opioids and evidence-based non-opioid alternatives for pain management with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives. In its 2020 OPPS final rule published on November 1, CMS did not add any products to the non-opioid exclusion from packaged payment. Although CMS had received an analysis of the Donnenfeld data, CMS specifically requested peer-reviewed published evidence and the Donnenfeld study had not yet been published at the time the final rule was issued. With the publication of the Donnenfeld opioid-sparing data, Omeros believes that Omidria meets all of CMS' requirements for the non-opioid exclusion. CMS stated in the final rule that it will continue to analyze the evidence in support of the benefits of Omidria and monitor utilization of this drug, and Omeros intends to address CMS' Omidria-related comments. Omeros also plans to continue its administrative and legislative efforts to secure ongoing separate payment for Omidria beyond the drug's current pass-through extension. Omidria continues to receive separate payment from CMS under its pass-through extension until October 1, 2020.
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TRS | Hot Stocks07:58 EDT TriMas announces increased share repurchase authorization to $150M - TriMas announced that its Board of Directors increased the company's common stock share repurchase authorization to $150M. The previous authorization, approved in February, authorized up to $75M in share repurchases.
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NERV CTLT | Hot Stocks07:57 EDT Minerva to complete enrollment for Phase 3 trial of roluperidone at year-end - The company said, "The Company is currently enrolling patients in the U.S. and Europe into a Phase 3 trial of roluperidone for the treatment of negative symptoms in schizophrenia. The Company expects to complete patient enrollment at approximately year-end 2019, and top line results from the 12-week, double-blind part of the trial are expected to be available in the first half of 2020. Following the most recent meeting of the Data Safety Monitoring Board in July, the DSMB recommended continuation of the study with no changes to the protocol. This trial is a multicenter, randomized, double-blind, parallel group, placebo-controlled, 12-week trial to evaluate the efficacy and safety of 32 mg and 64 mg doses of roluperidone as measured by the Positive and Negative Syndrome Scale Marder negative symptoms factor score. The core 12-week study is followed by a 40-week, open-label extension period during which patients on the drug continue receiving their original dose and patients on placebo receive one of the two doses of roluperidone. In September, 2019, the Company entered into a long-term commercial supply agreement with Catalent under which Catalent (CTLT) will manufacture and package the finished dose form of the drug. The Company is working with Catalent to enable the tech transfer from pilot to commercial-scale production."
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DAVA | Hot Stocks07:57 EDT Endava announces acquisition of Intuitus - Endava announced the purchase of Intuitu, headquartered in Edinburgh, Scotland. Intuitus is a leading independent provider of technology and digital due diligence, and other technology advisory services to Private Equity clients. "The acquisition of Intuitus will enhance Endava's capability and accelerate our penetration of this market segment. Technology is becoming ever more crucial to the investment thesis of Private Equity firms as they seek value transforming business change in their portfolio. They need to identify disruption opportunities and require external expertise to navigate the rapidly changing technology landscape."
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ENLV | Hot Stocks07:56 EDT Enlivex announces interim safety, efficacy data from ongoing Allocetra trial - Enlivex Therapeutics announced positive interim efficacy data from the Company's ongoing Phase Ib clinical trial in patients with severe sepsis. The interim analysis is based on a dataset of 43 patients with severe sepsis, all hospitalized at Hadassah Medical Center, which is one of the largest and most prestigious hospitals in Israel. Six patients admitted to Hadassah's intensive care unit with sepsis have been administered with off-the-shelf Allocetra upon their admission, while 37 patients were matched controls that received standard of care treatment during 2016-2019 but did not receive OTS Allocetra. The primary safety parameter was 28 days mortality. None of the OTS Allocetra -treated patients died during this period, compared to 11 of 37 in the matched control group who died during this period. OTS Allocetra treatment resulted in improved efficacy in all analyzed parameters, which included the sequential organ failure assessment score, as well as recovery from sepsis, number of days of hospitalization in the intensive care unit, and others. The matching of the 37 patients to the OTS Allocetra-treated group was based on similar organ failure clinical SOFA score at admission, overall clinical state, age group, sex, and source of severe sepsis. All matched patients were treated at the same hospital as the Allocetra-treated group.
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PEGI | Hot Stocks07:55 EDT Pattern Energy trading halted, news pending
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ESPR | Hot Stocks07:53 EDT Esperion announces pooled analyses from Phase 3 program of bempedoic acid - Esperion announced that pooled analyses from four Phase 3 clinical trials of bempedoic acid will be presented at the American Heart Association Scientific Sessions in Philadelphia on Sunday, November 17, 2019. Bempedoic acid is being developed as a cost-effective, convenient, once-daily, oral therapy for the treatment of patients with elevated low-density lipoprotein cholesterol added onto maximally tolerated statin therapy. Bempedoic acid and the bempedoic acid 180 mg + ezetimibe 10 mg fixed dose combination tablet's new drug applications are currently under regulatory review by the U.S. Food and Drug Administration, and the marketing authorisation applications are currently under centralized review by the European Medicines Agency. Esperion completed its global, pivotal, Phase 3 clinical development program and announced positive cumulative results in October 2018. The program evaluated the safety, tolerability and LDL-C-lowering efficacy of bempedoic acid and the bempedoic acid / ezetimibe combination tablets in patients with hypercholesterolemia who either have atherosclerotic cardiovascular disease or are at high risk of ASCVD, and who continue to have elevated levels of LDL-C despite the use of maximally-tolerated statins and ezetimibe, leaving them at high risk for cardiovascular events. The program included over 4,000 patients across five studies, four for bempedoic acid. With a targeted mechanism of action, bempedoic acid is a first-in-class, ATP Citrate Lyase inhibitor that lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptor. Bempedoic acid has been observed to reduce hsCRP, a key marker of inflammation associated with cardiovascular disease. Completed Phase 3 studies conducted in more than 4,000 patients, with over 2,600 patients treated with bempedoic acid, demonstrated up to 18 percent placebo corrected LDL-C lowering when used with moderate- and high-intensity statins and 21 to 28 percent placebo corrected LDL-C lowering when used with low dose or no background statin. Through the complementary mechanisms of action of inhibition of cholesterol synthesis and inhibition of cholesterol absorption, the bempedoic acid / ezetimibe fixed dose combination tablet is a non-statin, orally available, once-daily, LDL-C lowering therapeutic candidate, currently under review by the FDA and EMA. Inhibition of ATP Citrate Lyase by bempedoic acid lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptor. Inhibition of Niemann-Pick C1-Like 1 by ezetimibe results in reduced absorption of cholesterol from the gastrointestinal tract, thereby reducing delivery of cholesterol to the liver. Phase 3 data demonstrated that this combination resulted in a 29 percent placebo corrected LDL-C lowering when used with maximally tolerated statins, a 44 percent LDL-C lowering when used with no background statin, and a 34 percent reduction in high sensitivity C-reactive protein. The effect of bempedoic acid on cardiovascular morbidity and mortality has not yet been determined. Esperion initiated a global cardiovascular outcomes trial to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease who are only able to tolerate less than the lowest approved daily starting dose of a statin and considered "statin averse." The CVOT - known as CLEAR Cardiovascular Outcomes Trial - is an event-driven, global, randomized, double-blind, placebo-controlled study that completed enrollment in August 2019 of 14,032 patients with hypercholesterolemia and high CVD risk at over 1,400 sites in 32 countries
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TKS | Hot Stocks07:51 EDT Tomkins agrees to sell Lamons business to First Reserve for $135M in cash - TriMas announced that TriMas Company, a wholly-owned subsidiary of TriMas Corporation, has entered into a definitive agreement to sell its Lamons business to First Reserve, a private equity firm focused on energy investing, for $135 million in cash, subject to customary working capital and purchase price adjustments. The closing is expected to occur by the end of the first quarter of 2020, and remains subject to customary regulatory approvals and closing conditions.
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PLPRF | Hot Stocks07:48 EDT Plus Products appoints Jill Braff to board of directors - Plus Products announced the addition of Jill Braff, President of Brit + Co, to the Company's Board of Directors.
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HUBS | Hot Stocks07:47 EDT HubSpot acquires PieSync, terms not disclosed - HubSpot announced that it has acquired PieSync, the fastest-growing real-time intelligent customer data synchronization platform. PieSync is one of the only iPaaS offerings that provides both a current and historical two-way sync of customer data that operates in the background, freeing up precious time so companies can focus their energy on their customers instead of their software.
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KURA BIIB | Hot Stocks07:47 EDT Kura Oncology appoints James Basta as chief legal officer - Kura Oncology (KURA) announced the appointment of James Basta as Chief Legal Officer and corporate secretary. Basta will also serve as the company's Chief Compliance Officer. Most recently, he served as SVP, Chief Corporation Counsel at Biogen (BIIB), where he managed the legal representation for Biogen's securities filings, board of directors, business development, finance and tax, corporate affairs, employment and information technology.
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OPGN | Hot Stocks07:45 EDT OpGen says Curetis' Ares Genetics launches AI-powered molecular AST - OpGen reported an update on the business of Curetis GmbH, the other party to the planned business combination with OpGen. On October 28, 2019, Curetis, N.V. announced that its wholly-owned subsidiary Ares Genetics has launched an early access program for its novel, artificial intelligence powered, next-generation sequencing based molecular antibiotic susceptibility test. Information on antibiotic susceptibility of pathogens is of utmost importance for clinical practice, epidemiology and public health purposes as well as for the development of pharmaceutical products in the infectious disease sector. Ares Genetics therefore has developed a molecular AST that will be marketed under the brand name ARESupa - Universal Pathogenome Assay. It is an expanded version of the NGS-based ARESupa initially launched in August 2019 for the identification of pathogens and resistance genes. The new version of the ARESupa is now capable of also accurately predicting antibiotic susceptibility via AI-powered interpretation of high-throughput DNA sequencing data. Ares Genetics reports that it has received commercial orders for more than 1,000 ARESupa tests, an order volume exceeding EUR 500,000. Together with advanced bioinformatics and AI services leveraging ARESdb for the diagnostics and pharma industry, as well as access to certain rights, Ares Genetics has contracted for and received orders amounting to more than 2 million Euro in 2019 to date. OpGen and Curetis entered into a definitive agreement to combine businesses on September 4, 2019. The closing of the transaction under such definitive agreement has not yet occurred and is subject to a number of significant closing conditions, including receipt of approval from the stockholders of OpGen, Inc. and the shareholders of Curetis, N.V. Until the closing occurs, each of OpGen and Curetis are operating as stand-alone businesses.
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AFYA | Hot Stocks07:42 EDT Afya announces acquisition of UniRedentor for R$225M - Afya Limited announced the acquisition, through its wholly-owned subsidiary Afya Participacoes S.A., of 100% of the total share capital of UniRedentor - Sociedade Universitaria Redentor, or UniRedentor. The transaction is subject to antitrust regulatory approval. UniRedentor is a non-profit post-secondary education institution with governmental authorization to offer on-campus, undergraduate courses in medicine in the State of Rio de Janeiro. UniRedentor also offers other health-related undergraduate degrees and graduation programs in medicine and health. In 2018, UniRedentor's gross revenue totaled R$108M and more than 70% came from health-related programs. The aggregate purchase price was R$225M, of which: R$125M will be paid in cash as of the closing date, and R$20M is payable in five equal installments through June 2024, adjusted by the CDI rate. to The acquisition will contribute 112 medical school seats to Afya, increasing Afya's total medical school seats to 1,684 and will fortify Afya's presence in medical graduation courses.
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ADMA | Hot Stocks07:40 EDT ADMA Biologics announces acceptance to Plasma Protein Therapeutics Association - ADMA Biologics announced that it has been accepted as a member of the Plasma Protein Therapeutics Association as a North America Member effective January 1, 2020. Adam Grossman, President and CEO of ADMA, will join the PPTA North America Board of Directors.
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BCRX | Hot Stocks07:38 EDT BioCryst reports inducement grants under Nasdaq listing rule - BioCryst Pharmaceuticals announced that the compensation committee of BioCryst's board of directors granted five newly-hired employees options to purchase an aggregate of 217,500 shares of BioCryst common stock on October 31, 2019 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4). The options have an exercise price of $2.00 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.
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EYPT | Hot Stocks07:37 EDT EyePoint announces addition of DEXYCU, YUTIQ to VA federal supply schedule - EyePoint Pharmaceuticals announced that it has signed an interim agreement with the U.S. Department of Veteran Affairs for DEXYCU and YUTIQ to be included on the Federal Supply Schedule, providing U.S. veterans and other federal government agencies with access to both products. The VA FSS contract will extend access to Eyepoint products to over nine million VA beneficiaries and others within the federal system. The final VA contract is expected to be executed in the next few months and have a five-year term.
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REKR | Hot Stocks07:36 EDT Rekor Systems signs five-year licensing agreement with ParkSmart - Rekor Systems announced it has signed a five-year licensing agreement with ParkSmart for its iP360 Parking Ticket & Permit Management Software Suite. ParkSmart, a subsidiary of Coinamatic Canada, will first deploy the iP360 system within the City of Ottawa, enabling the city to manage and track parking tickets throughout the ticket lifecycle. Built using cutting edge Microsoft technology, iP360 creates processes for registered owner information management, adjudication management, payment integration, letter creation and reporting. It also comes with a permit management module and can be integrated within a city's handheld enforcement devices. The combination of Rekor's vehicle recognition systems with its iP360 platform creates a parking management solution. The system, powered by OpenALPR's AI-based software, allows additional capabilities such as gate access and fixed and portable camera monitoring using whitelist features. Data captured by the system can be used to create strategies to optimize parking management and enforcement, with more oversight of residential, employee and visitor parking. The powerful, dynamic platform can be used where any type of approved permits are valid. Customers have several permit management options including applying for a new permit for property including office building garages/lots, municipal garages/lots, convention centers, hotels, or multi-purpose developments.
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GNE JPM | Hot Stocks07:33 EDT Genie Energy: Prism Solar receives additional purchase orders from JPMorgan - Genie Energy (GNE) announced that its solar manufacturing subsidiary, Prism Solar Technologies , has received additional purchase orders from JPMorgan Chase Bank (JPM) to supply solar modules for installation at JPMorgan Chase facilities nationwide. JPMorgan Chase and Prism Solar previously reached a module supply agreement pursuant to which Prism Solar was named Preferred Supplier for the 2017-2020 JPMorgan Chase Solar PV Installation Program for locations in the USA.
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LANC | Hot Stocks07:33 EDT Lancaster Colony says Q2 is historically the biggest sales quarter - The company said, "Looking ahead to our fiscal Q2, historically our biggest sales quarter of the year, we will remain focused on our core strategic initiatives to grow our base business, pursue and achieve supply chain cost savings, and continue to integrate our recent acquisitions. Our ERP initiative, Project Ascent, is also progressing as planned with our internal team fully assembled and working with our system integrator. We will pursue a 'fit-to-standard' approach for the design and installation of an SAP software solution with the initial deployment planned to commence in the first half of FY21."
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KPTI | Hot Stocks07:32 EDT Karyopharm expects topline data from Phase 3 portion of SEAL stduy in 2020 - Karyopharm previously reported positive results from the Phase 2 portion of the randomized, blinded Phase 2/3 SEAL study evaluating single-agent selinexor versus placebo in patients with previously treated, advanced unresectable dedifferentiated liposarcoma. Enrollment is currently ongoing in the Phase 3 portion of the SEAL study. Top-line data from the Phase 3 portion of the SEAL study are anticipated in 2020. Assuming a positive outcome on the primary endpoint of PFS, the Company intends to use the data from the SEAL study to support NDA and MAA submissions requesting approval for selinexor for patients with advanced unresectable dedifferentiated liposarcoma.
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CME | Hot Stocks07:31 EDT CME Group says averaged 17M contracts per day in October, down 17% y/y - CME Group reached average daily volume of 17M contracts during October, down 17% from October 2018. Open interest at the end of October was 132M contracts, up 3% from October 2018, and up 14% from year-end 2018.
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KPTI | Hot Stocks07:31 EDT Karyopharm expects to submit NDA for selinexor by end of 2019 - Following the positive results from the Phase 2b SADAL study that were first presented at the America Society of Hematology 2018 Annual Meeting and then updated in June at the 2019 International Conference on Malignant Lymphoma, Karyopharm expects to submit a New Drug Application to the FDA by the end of 2019 requesting accelerated approval for selinexor as a treatment for patients with relapsed or refractory DLBCL after at least two prior multi-agent therapies and who are ineligible for stem cell transplantation including CAR-T therapy. The Company also expects to submit an MAA to the EMA in 2020 requesting conditional approval for selinexor in the same indication. In addition to orphan drug designation, selinexor was granted fast track designation for this indication by the FDA in 2018.
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HALO | Hot Stocks07:30 EDT Halozyme trading resumes
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KPTI | Hot Stocks07:29 EDT Karyopharm expects topline data from Phase 3 BOSTON study in early 2020 - Karyopharm's pivotal, randomized Phase 3 BOSTON study is progressing and patient enrollment was completed in January 2019. Top-line data are expected in early 2020 contingent upon the occurrence of progression-free survival events, the primary endpoint of the study. The BOSTON study is evaluating 100mg of selinexor dosed once weekly in combination with the proteasome inhibitor Velcade and low dose dexamethasone, compared to standard twice weekly Velcade and low dose dexamethasone in patients with multiple myeloma who have had one to three prior lines of therapy. Data from the BOSTON study, if positive, are expected to be used to support regulatory submissions to the FDA and EMA requesting the use of selinexor in combination with Velcade and dexamethasone in patients with multiple myeloma who have received at least one prior therapy.
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KPTI | Hot Stocks07:28 EDT Karyopharm expects to receive decision on MAA for selinexor in early 2020 - In January 2019, Karyopharm submitted an MAA to the EMA requesting conditional approval for selinexor, in combination with dexamethasone, as a new treatment for patients with heavily pretreated multiple myeloma based on the results of the Phase 2b STORM study. The Company expects to receive a decision on the MAA in early 2020.
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RBC | Hot Stocks07:27 EDT Regal Beloit announces new $250M share repurchase program - The Board of Directors on October 25 approved a new $250M share purchase authorization replacing the previous authorization.
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CDNA | Hot Stocks07:26 EDT CareDx announces launch of AlloSure 3.0 - CareDx announces the launch of AlloSure 3.0, the next iteration in continued transplant patient-focused improvements. CareDx has new data showing AlloSure provides more in-depth insights into patients with TCMR1A and borderline rejection. Data suggests the heterogeneous pattern of these diagnoses is associated with varying degrees of organ injury. The prospective, multicenter analysis across leading transplant centers shows that AlloSure remained low in patients that continued to have a stable clinical profile and was elevated in patients that had declining clinical profiles. This highlights the ability to use AlloSure to better risk stratify transplant patients with borderline, TCMR1A, and subclinical rejection.
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TRVN | Hot Stocks07:25 EDT Trevena expects to report topline data from TRV250 PoC study in 2H20 - The company said, "Initiated TRV250 acute migraine proof-of-concept study. This is a single-dose, double-blind, placebo-controlled study with an enrollment target of approximately 120 migraine patients in a validated nitroglycerin provocation migraine model. Patients will be randomized before receiving a continuous NTG infusion, followed by administration of a 20 mg subcutaneous dose of TRV250 or placebo. The primary objective of the study is to determine target engagement, which will be measured as a reduction of sustained NTG-induced headaches. This study will also evaluate the overall safety of TRV250 and its ability to reduce symptomatic anxiety. The Company anticipates reporting topline data from this study in the second half of 2020."
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TRVN | Hot Stocks07:24 EDT Trevena expects to resubmit NDA for oliceridine in 1Q20 - The company said, "Completed multi-dose QT study for oliceridine. No accumulation of effect was observed on the QT interval. A small, transient effect, consistent with that observed in the single-dose QT study, began dissipating after 12 hours and was absent at the end of the 24-hour study period despite repeated dosing of oliceridine. Oliceridine was well tolerated, with 59 subjects receiving the 27 mg maximum daily dose. There were no serious adverse events. In addition to this data, the Company previously announced that it has completed the work to address the other items requested by FDA in their complete response letter for oliceridine. The Company expects to resubmit the NDA for oliceridine in the first quarter of 2020."
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TRVN | Hot Stocks07:22 EDT Trevena expects cash, cash equivalents to fund requirements into 3Q20 - Cash, cash equivalents, and marketable securities were $44.7 million as of September 30, 2019. The Company believes its cash, cash equivalents, and marketable securities as of September 30, 2019, together with interest thereon, to be sufficient to fund the Company's operating expenses, debt service, and capital expenditure requirements into the third quarter of 2020.
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TNXP | Hot Stocks07:19 EDT Tonix announces 12-week primary endpoint for Phase 3 RECOVERY study - Tonix Pharmaceuticals Holding announced that in the currently-enrolling Phase 3 study of Tonmya for the treatment of posttraumatic stress disorder, the timing of the primary endpoint analysis has been changed from Week 4 to Week 12 and the Company plans to add an interim analysis that allows for a potential sample size adjustment, based on guidance from its recent Breakthrough Therapy Type B Clinical Guidance meeting with the U.S. Food and Drug Administration. The Phase 3 study design changes are being implemented after the FDA indicated the importance of showing persistence of treatment effect at Week 12 in a pivotal study. In the revised protocol, the primary endpoint, mean change from baseline in the severity of PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5, will be assessed at Week 12 instead of Week 4. Week 12 measurement of CAPS-5 was the same timepoint measurement used for the primary endpoint in the previous Phase 3 HONOR and the Phase 2 AtEase studies of Tonmya for PTSD. In addition, the RECOVERY study will include an unblinded interim analysis that allows for a potential sample size re-estimation. It will be conducted when 50 percent of the current target number of participants are randomized and have either completed or discontinued the 12-week course of treatment with bedtime Tonmya or placebo sublingual tablets. The introduction of the potential sample size re-estimation was added to address the potential impact of more drop-outs between Week 4 and Week 12, since the study was originally powered for a Week 4 endpoint. The data will be reviewed by an Independent Data Monitoring Committee which will make a non-binding recommendation to the Company based on the unblinded interim analysis. Pending final approval by FDA, the planned interim analysis will have three possible recommendations: 1) keep the current sample size and continue as planned; 2) provide the opportunity to increase the sample size to include up to a maximum of 120 additional participants, based on certain criteria; and 3) stop the study early for futility. The proposed design will not include an option to stop for positive efficacy at the interim analysis. The proposed sample size re-estimation methodology maintains the statistical hurdle of p less than 0.05. If the current sample size is kept at 250 participants at the interim analysis, there will be no statistical penalty on average compared to the current design. With an increase in sample size, the results from the cohorts before and after the interim analysis will be averaged with equal weight and p less than 0.05 will still be required for success. This methodology has been successfully utilized in other pivotal studies and was a component of the Phase 3 HONOR study's interim analysis that was agreed to by the FDA. Since more than 125 participants have already been enrolled, the Company expects to report the results of the interim analysis and the recommendation of the IDMC in the first quarter of 2020. If the current projected population of 250 study participants remains unchanged, the Company expects to report topline data in the second quarter of 2020.
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TIGR | Hot Stocks07:17 EDT UP Fintech subsidiary receives approval to conduct new businesses from FINRA - UP Fintech Holding announced that its wholly-owned subsidiary, US Tiger Securities, or USTS, received approval for conducting new businesses, including underwriting, private placements, mergers and acquisitions, mutual fund retailing, as well as selling group participant services from the Financial Industry Regulatory Authority, or FINRA, on October 16.
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IDXG | Hot Stocks07:15 EDT Interpace announces publication of two peer-reviewed articles on ThyGeNEXT - Interpace Group Interpace Diagnostics announced the publication of two peer-reviewed journal articles and one textbook chapter supporting the clinical utility of ThyGeNEXT when used alone and in combination with ThyraMIR. The most recent article was published in Diagnostic Cytopathology in a paper called "Incremental Utility of Expanded Mutation Panel When Used in Combination with MicroRNA Classification in Indeterminate Thyroid Nodules". An independent peer-reviewed journal article has been published in the Journal of Otolaryngology related to a study lead by Dr. Rick Payne from McGill University, Montreal, QC, Canada.
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IZEA | Hot Stocks07:14 EDT Izea announces contract expansions with multiple Fortune 500 customers - IZEA Worldwide announced that it has expanded its relationships with multiple Fortune 500 customers. The company has signed a mid six-figure managed services contract with a leading global retailer to provide influencer marketing services, pushing their total annual commitment to nearly $1.5M. In addition, the company has signed six-figure expansions with two other leading global retailers, each focused on influencer marketing promotions for the holidays.
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KPTI | Hot Stocks07:14 EDT Karyopharm expects cash, cash equivalents to fund operations into middle of 2021 - The company said, "Based on its current operating plans, Karyopharm expects its non-GAAP operating expenses, which excludes stock-based compensation expense, for the full year 2019 to be in the range of $200M to $210M. Karyopharm has not reconciled the full year 2019 outlook for non-GAAP operating expenses to full year 2019 outlook for GAAP operating expenses because Karyopharm cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense, which is excluded from the full year 2019 outlook for non-GAAP operating expenses. The Company expects that its existing cash, cash equivalents and investments, and the revenue it expects to generate from XPOVIO product sales, will be sufficient to fund its planned operations into the middle of 2021. Additional key activities expected in the remainder of 2019 include supporting the ongoing multiple myeloma regulatory filing for selinexor in Europe, progressing the pivotal Phase 3 BOSTON study in multiple myeloma and submitting an NDA in the U.S. in DLBCL."
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AVEO | Hot Stocks07:13 EDT Aveo Pharmaceuticals provides update after FDA meeting discussing TIVO-3 results - Aveo Pharmaceuticals provided a regulatory update following a meeting with the FDA to discuss results from the August overall survival, or OS, analysis of the TIVO-3 trial and the company's proposal to proceed with a new drug application, or NDA, for tivozanib. TIVO-3 is the company's Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib, the company's vascular endothelial growth factor receptor tyrosine kinase inhibitor, or VEGFR-TKI, to sorafenib in 350 subjects with highly refractory metastatic renal cell carcinoma, or RCC. The TIVO-3 trial was designed to address the FDA's concerns regarding the OS trend in the TIVO-1 trial. In the TIVO-1 trial, the company's initial RCC pivotal trial, the FDA found that the inconsistent progression free survival, or PFS, and OS results and imbalance in post study treatments made the trial results uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval. The company previously announced that the TIVO-3 trial met its primary endpoint of demonstrating a significant improvement in PFS. The study also demonstrated a significant improvement in the secondary endpoint of overall response rate. The August analysis of the secondary endpoint of OS was the second prespecified interim OS analysis of the TIVO-3 trial, and showed an updated OS hazard ratio, or HR, of 0.99 at two years from the last patient enrolled in the study. In the FDA's preliminary feedback, based on its assessment of the totality of evidence presented to date, the FDA recommended that the company not submit an NDA at this time. The FDA stated that it remained concerned about the results of TIVO-3 in the context of the overall development of tivozanib. The FDA noted that the company's current interim OS results do not abrogate the FDA's concerns over detriment and that those results may worsen with final analysis at 263 events and that the median OS for tivozanib is worse than that of sorafenib. In view of the changing first-line treatment landscape as well as the FDA's continued concerns, the company informed the FDA that it intends to narrow its proposed indication to relapsed/refractory RCC. At the meeting, the FDA acknowledged AVEO's responses and reiterated its concerns about the survival information and the totality of data. The FDA noted that the choice to submit the data is the company's, and that a discussion with the Oncologic Drug Advisory Committee will likely be required. The FDA said that if AVEO wishes to proceed with a revised OS analysis in June 2020, AVEO should submit an updated statistical analysis plan, or SAP, with a planned OS update based on the projected number of events at that time. AVEO intends to submit to the FDA an update to the SAP for the final OS analysis consistent with these discussions, followed by an NDA submission in Q1 of 2020. AVEO expects to report the final OS analysis in June 2020 based on a May 1, 2020 cutoff, at which point the company estimates that the study will have reached approximately 263 OS events, as discussed with the FDA. The FDA and the company agreed that if the final analysis yields an OS HR above 1.00, the company will withdraw its NDA application.
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CORV | Hot Stocks07:13 EDT FDA to hold advisory meeting to to review NDA for Correvio's Brinavess - Correvio Pharma announced that the FDA will hold a Cardiovascular and Renal Drugs Advisory Committee, or CRDAC, meeting in connection with its review of the pending New Drug Application, or NDA, for Brinavess. The meeting will be held on December 10 from 8:00 a.m. to 5:00 p.m. ET. The proposed indication to be discussed at this upcoming CRDAC meeting is for the rapid conversion of recent onset atrial fibrillation, or AF, to sinus rhythm in adult patients. Correvio's NDA is currently under review by the FDA with an action date of December 24 under the Prescription Drug User-Fee Act, or PDUFA.
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ICUI | Hot Stocks07:12 EDT ICU Medical to acquire Pursuit Vascular for $75M - ICU Medical announced that it has entered into a definitive agreement to acquire Pursuit Vascular for $75M with an additional earnout payment potentially due in 2021. Pursuit Vascular is a privately-held medical device company with a primary focus on innovative catheter disinfecting products and technologies to reduce costly bloodstream infections and lower healthcare costs. Pursuit Vascular's primary product is the ClearGuard HD cap, which is used for the maintenance of hemodialysis catheters. Patients receiving dialysis treatments are at high risk of getting an infection because of the need to access their blood frequently. ClearGuard HD kills infection-causing bacteria and fungi inside of a hemodialysis catheter to help reduce infections. It is a safe, effective, and easy-to-use solution that has been shown in two large scale clinical studies to reduce bloodstream infections by approximately 70% when compared to current products. Pursuit Vascular's full-year 2019 annual revenues are estimated to be between $10M-$12M with margins comparable to the existing ICU Medical IV consumables business. The transaction will be funded with cash on hand and is not expected to have a material impact on the company's current adjusted EBITDA and adjusted EPS guidance for 2019.
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RESN TDY | Hot Stocks07:11 EDT Resonant enters partnership with Teledyne Scientific - Resonant (RESN) announced that it is partnering with Teledyne Scientific & Imaging (TDY) to develop manufacturing processes for high frequency, wide bandwidth RF filter solutions. "Teledyne's advanced capabilities in microelectromechanical systems and micromachining technologies make it the perfect foundry to partner with on the development of manufacturing processes of our high frequency, wide bandwidth RF filter solutions," said George Holmes, Chairman and CEO of Resonant. "Our filter technology, developed using our Infinite Synthesized Networks software platform, is uniquely positioned to address the wide bandwidth and high frequency requirements for 5G New Radio and WiFi filters in the 3 GHz to 38 GHz spectrum and by partnering with an industry-leading foundry such as Teledyne, we are working on the next step to bring our industry leading technology to the RF filter marketplace in timely and cost effective manner."
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OBE | Hot Stocks07:10 EDT Obsidian Energy reaffirms FY19 production view 26,750boe/d-27,750boe/d
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CGEN | Hot Stocks07:10 EDT Compugen announces FDA clearance on IND application for COM902 - Compugen announced that the U.S. FDA has cleared its investigational new drug application for COM902, its immuno-oncology therapeutic antibody targeting TIGIT in patients with advanced malignancies. Under this IND, the company intends to initiate a Phase 1 clinical trial in patients with advanced malignancies for whom standard of care therapies are currently ineffective. Expected to begin in early 2020, the clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of COM902. The study is planned to be conducted at multiple centers in the United States and site selection activities are currently underway.
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HALO | Hot Stocks07:08 EDT Halozyme announces restructuring, to reduce headcount approximately 55% - Halozyme Therapeutics announced strategic actions to reposition the company with a focus solely on its ENHANZE drug delivery technology. In order to implement this strategic shift, Halozyme will immediately initiate an organizational restructuring to halt development activities for PEGPH20 and close its oncology operations. As a result, Halozyme expects the following: Headcount will be reduced by approximately 55%, or approximately 160 positions, with over 80% of the reduction completed in early January 2020. Restructuring and other cost saving efforts will result in savings of $130M-$140M in 2020 compared with the company's most recent guidance for 2019 operating expenses excluding cost of goods sold. Upon completion of the restructuring and after booking all related one-time charges, Halozyme anticipates becoming a sustainably profitable company beginning in the second quarter of 2020. Projected annualized operating expenses excluding cost of goods sold of between $65M-$75M will be achieved by the fourth quarter of 2020. The company expects to book separation and contract termination fees in the fourth quarter and will provide further details during its third quarter financial results webcast and conference call on Tuesday, November 12. The go-forward organization will comprise approximately 120 employees focused on driving the continued growth of ENHANZE, specifically in areas that are critical to supporting partners such as manufacturing, quality, regulatory and product development. An additional 12 employees will continue promoting the company's commercial drug Hylenex. The company's ENHANZE business continues to grow with three commercial products and 11 products currently in clinical trials. Halozyme will provide a more detailed update for its ENHANZE business during its third quarter financial results webcast and conference call. Halozyme's Board of Directors has also authorized the initiation of a capital return program to repurchase up to $350M of the company's outstanding common stock over the next three years. The timing of share repurchases and the number of shares of common stock that are repurchased will depend on market conditions and other factors. Repurchases may be commenced or suspended at any time or from time-to-time at the company's discretion without prior notice. Repurchases may be made through both public market and private transactions. The Board will regularly review this capital return policy in connection with a balanced capital allocation strategy.
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WMGI SYK | Hot Stocks07:06 EDT Stryker to acquire Wright Medical for $30.75 per share in cash - Stryker (SYK) announced a definitive agreement to acquire all of the issued and outstanding ordinary shares of Wright Medical Group N.V. (WMGI) for $30.75 per share, or a total equity value of approximately $4B and a total enterprise value of approximately $5.4B. Wright Medical, which was founded in 1950, is a global medical device company focused on extremities and biologics. Wright Medical brings a highly complementary product portfolio and customer base to Stryker's trauma and extremities business. With global sales approaching $1B, Wright Medical is a recognized leader in the upper extremities, lower extremities and biologics markets, which are among the fastest growing segments in orthopaedics. Wright Medical's leading upper extremity portfolio and advanced preoperative planning technology will significantly add to Stryker's offering. Additionally, Wright Medical's lower extremity and biologics will complement Stryker's portfolio and strengthen the company's position in this high-growth segment. Under the terms of the agreement, Stryker will commence a tender offer for all outstanding ordinary shares of Wright Medical for $30.75 per share, in cash. The boards of directors of both Stryker and Wright Medical have approved the transaction. The closing of the transaction is subject to receipt of applicable regulatory approvals, the adoption of certain resolutions relating to the transaction at an extraordinary general meeting of Wright Medical shareholders, completion of the tender offer and other customary closing conditions. The acquisition of Wright Medical is expected to close in the second half of 2020 and is expected to have no impact to Stryker's net earnings per diluted share and adjusted net earnings per diluted share in 2019. There is no change to Stryker's previously announced expected adjusted net earnings per diluted share for the full year, which is a range of $8.20 - $8.25. Assuming a September 30, 2020 closing, the transaction is expected to have no impact to Stryker's adjusted net earnings per share in 2020, 10c dilution in 2021 and will be accretive thereafter.
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HALO | Hot Stocks07:05 EDT Halozyme says HALO-301 Phase 3 study fails to meet primary endpoint - Halozyme Therapeutics announced that the HALO-301 Phase 3 clinical study evaluating investigational new drug PEGPH20 as a first-line therapy for treatment of patients with metastatic pancreas cancer failed to reach the primary endpoint of overall survival. The treatment arm of PEGPH20 in combination with gemcitabine and nab-paclitaxel failed to demonstrate an improvement in median overall survival compared to gemcitabine and nab-paclitaxel alone. While there was a higher response rate in the PEGPH20 treatment arm, this did not translate into an improvement in duration of response, Progression Free Survival or Overall Survival. "Patients in both treatment arms of the HALO-301 trial surpassed the published median overall survival rates from the pivotal registration study of ABRAXANE plus gemcitabine as first-line therapy for metastatic pancreas cancer, published in 2013. Based on the lack of benefit over standard-of-care in this study, which performed well versus published data, we will be discontinuing PEGPH20 clinical development," said Dr. Helen Torley, president and CEO of Halozyme. "This well-designed and well-executed study did not have the outcome that we or the study participants wanted or expected. I would like to extend a heartfelt thank you to all those who supported and who made this study possible, including the patients who were enrolled, their families, our investigators, their staff, our investors and all of the dedicated Halozyme employees." Halozyme intends to halt development activities for PEGPH20 and implement an organizational restructuring to focus its operations solely on its ENHANZE drug delivery technology.
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IBKC FHN | Hot Stocks07:04 EDT Iberiabank, First Horizon to combine in all-stock merger of equals - First Horizon National Corp. (FHN) and IBERIABANK Corporation (IBKC) announced that they have entered into a definitive agreement under which the companies will combine in an all-stock merger of equals.Under the terms of the agreement, which was unanimously approved by the Boards of Directors of both companies, the combined holding company and bank will operate under the First Horizon name and will be headquartered in Memphis, Tenn. Once the transaction is completed, the combined company will be one of the largest financial services companies headquartered in the South and one of the top 25 banks in the U.S. in deposits. Under the terms of the merger agreement, IBERIABANK shareholders will receive 4.584 shares of First Horizon for each IBERIABANK share they own. First Horizon shareholders will own 56% and IBERIABANK shareholders will own 44% of the combined company. Additionally, IBERIABANK shareholders will receive a 43% increase in their dividend after consummation of the transaction, based upon each company's current dividend per share. The transaction is projected to deliver approximately 16% EPS accretion to First Horizon and approximately 22% EPS accretion to IBERIABANK by year-end 2021. The transaction is expected to deliver approximately $170M in pre-tax cost synergies, primarily driven by annual run-rate cost savings such as redundancies in overhead, bank branches, operations and computer services. The combined company will be headquartered in Memphis, Tenn., and will maintain a significant operating presence in all of the markets in which both companies operate today. The combined company's regional banking headquarters will be located in New Orleans, La. Upon closing of the transaction, the Board of Directors will consist of nine directors from First Horizon and eight directors from IBERIABANK. The new company will be led by Daryl G. Byrd as Executive Chairman of the Board of Directors and D. Bryan Jordan as CEO. The merger is expected to close in the second quarter of 2020, subject to satisfaction of customary closing conditions, including receipt of customary regulatory approvals and approval by the shareholders of each company
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WMGI SYK | Hot Stocks07:03 EDT Wright Medical to be acquired by Stryker for $30.75 per share in cash - Wright Medical Group (WMGI) announced that it has entered into a definitive agreement under which Stryker (SYK) will acquire all of the issued and outstanding ordinary shares of Wright Medical Group N.V. for a total equity value of approximately $4.7B, including the value of Wright's outstanding convertible notes, and total enterprise value of approximately $5.4B. Under the terms of the agreement, Stryker will commence a tender offer for all outstanding ordinary shares of Wright for $30.75 per share, in cash. The boards of directors of both Stryker and Wright have approved the transaction. The closing of the transaction is subject to receipt of applicable regulatory approvals, the adoption of certain resolutions relating to the transaction at an extraordinary general meeting of Wright's shareholders, completion of the tender offer and other customary closing conditions. The offer of $30.75 per share in cash represents a premium of 52% over the volume-weighted average closing price of Wright ordinary shares over the thirty calendar days ended October 31, 2019, the last trading day prior to speculation that Wright was exploring a sale of the company. The acquisition is expected to close in the second half of 2020. Wright brings a highly complementary product portfolio and customer base to Stryker's trauma and extremities business. With global sales approaching $1B, Wright is a recognized leader in the upper extremities, lower extremities and biologics markets, which are among the fastest growing segments in orthopaedics. Wright's leading upper extremity portfolio and advanced preoperative planning technology will significantly add to Stryker's offering. Additionally, Wright's lower extremity and biologics will complement Stryker's portfolio and strengthen the company's position in this high-growth segment.
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GE | Hot Stocks07:03 EDT GE Healthcare announces FDA approval of Clariscan - The FDA has approved Clariscan, a macrocyclic, ionic, gadolinium-based, MRI contrast agent, expanding the GE Healthcare portfolio for U.S. patients and radiologists. Clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging, or MRI, in brain, spine and associated tissues in adult and pediatric patients to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity.
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IBKC FHN | Hot Stocks07:02 EDT Iberiabank, First Horizon to combine in all-stock merger of equals
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GCO | Hot Stocks06:57 EDT Genesco CEO Robert Dennis to leave role, Mimi Vaughn to succeed - Genesco announced that Mimi Vaughn, currently the company's senior VP and COO, has been named Genesco's next president and CEO, effective February 2, 2020, the start of the company's new fiscal year. In addition, Vaughn was elected to Genesco's board of directors, effective immediately. Vaughn will succeed Robert Dennis, Genesco's current chairman, president and CEO, who will continue to serve as the company's executive chairman. During his 15-year career with the Company, Dennis has led Genesco as president and CEO for 11 years and served as chairman for the past nine years. Matthew Diamond will continue to serve as the company's lead outside director. Vaughn joined Genesco as VP - strategy and business development in 2003, was promoted to senior VP - strategy and business development in 2006, and was named senior VP - strategy and shared services in 2009. Vaughn became CFO in 2015, and was named Genesco's COO in January 2018. She formally assumed the role in May following the appointment of Mel Tucker as CFO.
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HALO | Hot Stocks06:55 EDT Halozyme trading halted, news pending
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NBY | Hot Stocks06:52 EDT NovaBay announces availability of full-strength CelleRx for consumers - NovaBay Pharmaceuticals announces the availability of full-strength CelleRx for consumer purchase without a prescription in the U.S. at CelleRx.com. CelleRx is a skin and wound cleanser based on NovaBay's proprietary pure hypochlorous formulation, and is proven to gently clean and ease discomfort following aesthetic dermatology and cosmetic surgery procedures.
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IGT | Hot Stocks06:48 EDT International Game subsidiary signs contract extension with Kentucky Lottery - International Game announced that its subsidiary, IGT Global Solutions, has signed a contract extension with the Kentucky Lottery Corporation for five years through July 9, 2026. The lottery is exercising its five one-year extension options in which IGT will provide new self-service lottery vending machines and updated technology. Under the terms of the extension, IGT will provide the lottery with additional 575 GameTouch 28 self-service vending machines and equip approximately 1,400 total GameTouch 28, GameTouch 20, and GameTouch draw machines with cashless functionality that enables players to use credit or debit cards to purchase lottery products. In addition to these products, IGT provides the Kentucky Lottery with facilities management, field service, call center services and marketing support.
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MEDIF | Hot Stocks06:38 EDT Medipharm Labs names Robert Kwon as CFO, effective November 18 - MediPharm Labs pleased to announce Robert Kwon will join MediPharm Labs as CFO, effective November 18. Christopher Hobbs, the company's current CFO will continue to serve on the Board of MediPharm Labs. Most recently, Kwon served as the Senior Vice President of George Weston Ltd., Canada's largest food and drug retail business.
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CERC AYTU | Hot Stocks06:34 EDT Cerecor closes sale of pediatric portfolio to Aytu BioScience for $43M - Cerecor (CERC) announced that it has closed the sale of its pediatric portfolio of assets with AYTU BioScience (AYTU) in a deal valued in excess of $43M including the assumption of various liabilities and product-related obligations. The consideration includes a combination of cash and Aytu preferred stock totaling $17M and the assumption of Cerecor's outstanding payment obligations payable to Deerfield CSF in the amount of $15M and certain other liabilities in excess of $11M, providing non-dilutive cash generation for Cerecor. The funds from the transaction, coupled with the removal of the aforementioned short-term obligations, extend the runway toward NDA submission of CERC-801 and its associated Priority Review Voucher. Overall deal valued in excess of $43M as a composite of $17M in cash and preferred stock, the assumption of the Deerfield Note of $15M, the assignment of the existing royalty obligations coupled with various commercial accruals of $11M. Cash has been paid, and the Shares were issued at closing; the Shares are subject to customary lock-ups and are convertible to common shares following Aytu stockholder approval and immediately prior to their sale or distribution.
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IGLD | Hot Stocks06:13 EDT Internet Gold sees Searchlight Transaction closing on November 21 - Internet Gold announced, further to the company's report dated October 27 regarding B Communications Ltd.'s nnouncement of an updated anticipated schedule for closing of the Searchlight Transaction, that on November 1, 2019 BComm announced an additional update to the anticipated schedule for closing of the Searchlight Transaction. According to BComm's announcement, the updated expected date for the closing of the Searchlight Transaction is November 21. As previously announced, if the Searchlight Transaction is completed, the company will not be able to fully pay its debts, and the company intends to initiate a creditors' arrangement which would be submitted to the applicable Israeli court. The company anticipates that pursuant to such arrangement the existing shares of the company will be nullified and that the creditors of the company will receive, inter alia, 100% of the shares of the company.
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BNOEF | Hot Stocks06:11 EDT Bionomics: FDA Fast Track Designation granted to BNC210 development program - Bionomics announced that the U.S. FDA has granted Fast Track designation to the BNC210 development program for the treatment of Post-Traumatic Stress Disorder and other trauma-related and stressor-related disorders. Bionomics is currently developing a novel solid dose formulation of BNC210 which has recently been shown to achieve the blood levels predicted as necessary to meet the clinical trial primary endpoint for effectiveness for treating PTSD patients; preparations are underway for optimization of the solid dose formulation in anticipation of initiation of a Phase 2b trial in PTSD patients.
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AAPL | Hot Stocks06:09 EDT Apple commits $2.5B to address housing crisis in California - Apple announced a comprehensive $2.5B plan to help address the housing availability and affordability crisis in California. "Apple's commitment to the state of California includes: $1 billion affordable housing investment fund: The $1 billion commitment to the state of California is a first-of-its-kind affordable housing fund that will provide the state and others with an open line of credit to develop and build additional new, very low- to moderate-income housing faster and at a lower cost. $1 billion first-time homebuyer mortgage assistance fund: Working with the state, this first-time homebuyer fund will provide aspiring homebuyers with financing and down payment assistance. Apple and the state will explore strategies to increase access to first-time homeownership opportunities for essential service personnel, school employees and veterans. $300 million Apple-owned land will be available for affordable housing: Apple intends to make available land it owns in San Jose worth approximately $300 million for the development of new affordable housing. The funding commitment to California is expected to take approximately two years to be fully utilized depending on the availability of projects. Capital returned to Apple will be reinvested in future projects over the next five years. In addition to these initiatives, Apple is working to identify private developers who, with the right financing and investment, are ready to start construction on affordable housing projects in the Bay Area immediately. Apple will also provide $200 million to support new lower-income housing and help some of the most vulnerable populations in the Bay Area: $150 million Bay Area housing fund: In a public-private partnership, Apple is launching a new $150 million affordable housing fund with partners including Housing Trust Silicon Valley to support new affordable housing projects. The fund will consist of long-term forgivable loans and grants. $50 million to support vulnerable populations: Apple will donate $50 million to support Destination: Home's efforts to address homelessness in Silicon Valley. Apple will focus its contribution on driving systemic change across the many factors affecting homelessness. Apple will also be identifying similar efforts in Northern and Southern California, focusing on strategies that both end and prevent homelessness."
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RDHL | Hot Stocks06:06 EDT RedHill Biopharma announces FDA approval of Talicia - RedHill Biopharma announced that the U.S. FDA has approved Talicia delayed-release capsules 10 mg/250 mg/12.5 mg for the treatment of Helicobacter pylori infection in adults. RedHill expects to launch Talicia in the U.S. in the first quarter of 2020 with its dedicated sales force. Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to current clarithromycin-based standard-of-care therapies. It is estimated that H. pylori resistance to clarithromycin more than doubled between 2009-2013.
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NSTG | Hot Stocks06:06 EDT NanoString announces of its new GeoMx Cancer Transcriptome Atlas - NanoString Technologies announced the availability of its new GeoMx Cancer Transcriptome Atlas through the Technology Access Program, or TAP, for the GeoMx Digital Spatial Profiler, or DSP. This new high-plex RNA expression profiling panel provides the most informed view of the cancer transcriptome based on evidence from the Cancer Genome Atlas Program as well as important immuno-oncology biology. The assay is compatible with both fresh frozen, or FF, and Formalin-Fixed Paraffin-Embedded tissue, or FFPE enabling researchers to access more samples to power their studies.
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APHA | Hot Stocks06:04 EDT Aphria doubles production capacity after receiving cultivation licence - Aphria announced it has received a cultivation licence from Health Canada for Aphria Diamond, the company's second Leamington, Ontario cannabis greenhouse facility, bringing an additional 1,300,000 square feet of production space with an annual growing capacity of 140,000kg. Combined with the company's Aphria One facility and its subsidiary Broken Coast Cannabis, the Company now has more than 2,400,000 square feet of cultivation space capable of reaching a total annualized production capacity of 255,000kg.
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REED | Hot Stocks06:03 EDT Reed's CFO Iris Snyder departs, Joann Tinnelly named interim CFO - Reed's announced the departure of CFO Iris Snyder, who is leaving the company to pursue another opportunity, and the appointment of Joann Tinnelly as Interim CFO. Iris Snyder, who has served as Reed's CFO since July 2018, is leaving the company to pursue an opportunity with a private food company. Snyder will continue to serve as Reed's CFO until November 22, and work closely with Tinnelly to ensure a seamless transition. Tinnelly brings almost 30 years of finance and accounting experience in global public and private equity company environments. She has served as Vice President and Corporate Controller of Reed's since July 2018. Prior to joining Reed's she served at Assistant Controller of Steel Excel, a subsidiary of Steel Partners Holdings.
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UAA UA | Hot Stocks05:45 EDT Under Armour says cooperating with DOJ, SEC accounting investigations - Under Armour said last night in a statement to CNBC: "Under Armour is cooperating with the U.S. Securities and Exchange Commission and the U.S. Department of Justice investigations. The company began responding in July 2017 to requests for documents and information relating primarily to its accounting practices and related disclosures, and the company firmly believes that its accounting practices and disclosures were appropriate." Shares of Under Armour (UAA) are down 16%, or $3.43, to $17.71 in premarket trading. Reference Link
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HTHT | Hot Stocks05:42 EDT Huazhu Group announces acquisition of Deutsche Hospitality for EUR 700M - Huazhu Group announced that the company, through its wholly owned subsidiary China Lodging Holding Singapore, entered into a share purchase agreement to acquire all shares in Steigenberger Hotels Aktiengesellschaft, Germany, or "Deutsche Hospitality," for a base cash consideration of about EUR 700M, which is subject to net working capital and other post-closing adjustments as provided in the Agreement. The acquisition is subject to regulatory approvals and certain other closing conditions, and is expected to close on or around early next year.
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AMZN | Hot Stocks05:23 EDT Amazon expands delivery options during holiday season - With the holiday season officially underway, Amazon has expanded its fast, free, and convenient delivery options. "From Los Angeles, California and Killeen, Texas to Elkhart, Indiana and Philadelphia, Pennsylvania, Prime members across the U.S. now have access to over 10 million items available for delivery the next day for free, including popular holiday gifts such as toys, games, and electronics. Amazon has also expanded its Prime Free Same-Day Delivery, bringing the convenience of doorstep delivery within hours to millions more members since last holiday season. This is in addition to free shipping on millions of items that all customers can enjoy year-round on orders over $25."
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ERYP | Hot Stocks05:15 EDT Erytech Pharma opens U.S. enrollment in TRYbeCA1 Phase 3 clinical trial - Erytech Pharma announced two important milestones for the TRYbeCA1 Phase 3 clinical trial of eryaspase in second line metastatic pancreatic cancer. TRYbeCA1 was opened for patient enrollment in the United States last week, and the first of a planned total of 30 U.S. sites was activated. This marks an important step to expand the trial to approximately 100 sites across several European countries and the U.S. The manufacturing of eryaspase for the patients to be treated in the U.S. will take place at the newly established manufacturing facility in Princeton, N.J. Separately, on October 29, further to its review of the safety data of the first 150 enrolled and treated patients in the TRYbeCA1 trial, the Independent Data Monitoring Committee, or IDMC, identified no safety issues and recommended the trial to continue as planned.
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