Stockwinners Market Radar for October 12, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
GLD | Hot Stocks18:22 EDT SPDR Gold Shares holdings rise to 1,277.65MT from 1,271.52MT - This is the highest level of holdings since September 22nd.
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AOS | Hot Stocks17:52 EDT A.O. Smith raises quarterly dividend 8% to 26c from 24c per share - The dividend increase affects the company's Common Stock and Class A Common Stock. The dividend is payable on November 16 to shareholders of record October 30.
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SRNE | Hot Stocks17:26 EDT Sorrento Therapeutics enters exclusive license agreement with PSC for MSC rights - Sorrento Therapeutics announced that it has entered into an exclusive license agreement with Personalized Stem Cells, or PSC, to acquire global rights to its adipose derived mesenchymal stem cells, or MSCs, for patients suffering from acute respiratory distress syndrome, or ARDS, associated with COVID-19, which have been cleared for a Phase 1 clinical trial by the FDA. The study is a single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of an adipose-derived allogeneic MSC product candidate. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site as the enrolled patients. The primary objective is to evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 and in respiratory distress. The secondary objective is to evaluate a set of safety and efficacy outcome variables to give guidance regarding the risk/benefit ratio in patients with COVID-19 respiratory distress. Sorrento will be assuming responsibility for executing the Phase 1 trial, which is targeted to enroll about 20 hospitalized COVID-19 patients in California. Pending the results of the Phase 1 trial, Sorrento expects to expand into Phase 2 trials in multiple relevant geographies as may be determined in consultation with applicable regulatory authorities. Stem cells have been demonstrated to support resolution of symptoms in multiple disease settings and have the potential to reduce the long-term effects associated with pulmonary tissue damage for these patients. Stem cells represent a treatment modality with high potential to help in the fight against COVID-19 as a stand-alone therapy or in synergy with other product candidates in Sorrento's pipeline, including small molecules and neutralizing antibodies.
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LIVN | Hot Stocks17:17 EDT LivaNova confirms discussions with PrimeStone Capital over past several months - LivaNova confirmed receipt of a letter from PrimeStone Capital to its Board of Directors and issued the following statement: "LivaNova welcomes open communication and values constructive input toward the goal of enhancing value for all LivaNova shareholders. The company's Board of Directors and management will continue to take actions to achieve this objective. Members of the company's executive leadership team and the Board have held discussions with PrimeStone over the past several months. LivaNova regularly evaluates the company's strategic plan and remains focused on execution, while upholding its mission to provide hope for patients through innovative medical technologies and to deliver life-changing improvements for the Head and Heart."
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ATVI... | Hot Stocks17:09 EDT Twitch Studio announces new 'tools to achieve pro quality streams' - Amazon's (AMZN) Twitch said in a blog posting, in part: "Since we first launched Twitch Studio we've continued to work with the community to provide even more features to help you take your streams to the next level. Today we're excited to share our latest batch of tools to help you achieve pro quality streams, whether you're brand new to Twitch Studio or have been using the app since day one. A Customizable and Flexible Interface: Design your Twitch Studio layout in a way that best suits your style and channel content. Control which panels you want to display and where exactly you want them placed by dragging and dropping to save time building your personalized layout. Editor Updates, Countdown Timer Chat Overlay, Dual-PC Support. Other publicly traded companies in the space include Activision Blizzard (ATVI), Electronic Arts (EA), GameStop (GME), Nintendo (NTDOY), Take-Two (TTWO) and Ubisoft (UBSFY). Reference Link
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MRUS | Hot Stocks17:05 EDT Merus, myTomorrows expand NRG1 fusion cancers collaboration - MyTomorrows, a global health technology company, and Merus announced the expansion of their ongoing collaboration to raise awareness of screening opportunities for and recruitment of patients with neuregulin 1, or NRG1, fusion cancers. Under a 2019 agreement, myTomorrows has been providing support to eligible patients with NRG1 gene fusion cancers to participate in Merus' early access program and to receive zenocutuzumab. Expanding the relationship, myTomorrows has agreed to raise awareness of the molecular screening offered by Merus focusing on pancreatic cancer, to identify the presence of NRG1 fusions and to increase awareness of and potential enrollment in Merus' eNRGy clinical trial. Patients recruited into the eNRGy clinical trial have cancers that harbor the NRG1 gene fusion, a rare and powerful driver of cancer cell growth found in lung, pancreatic and other solid tumor types. Merus is currently enrolling patients on the Phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers. The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and NRG1+ other solid tumors.
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WSM | Hot Stocks17:01 EDT Williams-Sonoma resumes share repurchase program - Given the on-going strength of its business and liquidity position, the company has also decided to resume its share repurchase program and has repaid in full the short-term borrowings under its $500M revolver. "Our decisions to increase our quarterly dividend, resume our share buyback program and pay down our revolver reflect the strength of our business and financial position, and our commitment to maximizing returns for our shareholders," said Laura Alber, President and CEO. "Our strong performance during this pandemic reinforces the relevance of our curated, sustainable products and the power of our digital-first platform. We are seeing an inflection point in our business and are more confident than ever in our strategies to deliver strong, long-term growth with increasing profitability."
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WSM | Hot Stocks17:01 EDT Williams-Sonoma raises quarterly dividend 10% to 53c per share - This quarterly dividend is payable on November 27 to stockholders of record as of the close of business on October 23.
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SAIA | Hot Stocks16:41 EDT Saia opens new, 60% larger cross-dock facility in Memphis - Saia announced the opening of its new, larger Saia LTL Freight cross-dock facility in Memphis, Tennessee. The 200 door terminal continues includes an eight bay maintenance facility and a high speed fueling station. Saia will still employ nearly 300 team members at the new terminal, which has the space to accommodate an expansion over time as the company continues to see long-term growth both in Memphis and nationally. This is the third Saia re-location in the last couple of months. Saia recently moved its operations to new, larger facilities in Sherman and Wichita Falls, Texas. Earlier this year, Saia moved its Las Vegas, Nevada terminal and this November, it will be moving its Green Bay, Wisconsin operations to a new facility as well. "The new terminal is 60 percent larger than our previous facility and will allow us to meet the needs of our shippers today and for the foreseeable future," said executive VP of operations Paul Peck. "It's a significant investment in our network, and the community, and is another flagship facility that we are tremendously proud of."
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DIS | Hot Stocks16:39 EDT Disney up 4% after announcing reorganization of media, entertainment units - In after hours trading, shares are up over 4% to $130.60.
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UDR CONE | Hot Stocks16:38 EDT UDR appoints CyrusOne CFO Diane Morefield to its board - UDR (UDR) announced the appointment of Diane Morefield to its board effective October immediately. Morefield will serve as an independent director. Morefield has served as executive VP and CFO at CyrusOne (CONE) since joining the company in 2016.
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DIS | Hot Stocks16:36 EDT Disney CEO says theme parks operating at 25% capacity - Says reorganization of its media and entertainment businesses may result in more layoffs. Bob Chapek is speaking on CNBC.
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SNPS | Hot Stocks16:31 EDT Synopsys unveils Silicon Lifecycle Management platform - The company states: "Synopsys unveiled its Silicon Lifecycle Management platform, the industry's first data-analytics-driven approach to optimizing SoCs from the design phase through to end-user deployment. The SLM platform, which is tightly coupled with Synopsys' market-leading Fusion Design Platform, will provide visibility into critical performance, reliability and security issues for the entirety of a chip's lifespan. It will enable new levels of insights for both SoC teams and their customers and provide the ability to optimize operational activities at each stage of the device and system lifecycles."
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AB | Hot Stocks16:21 EDT AllianceBernstein reports preliminary AUM $631B as of September 30 - Down from $643B at the end of August. The 1.9% decrease was due primarily to market depreciation, and to a lesser extent, firmwide net outflows. By channel, net outflows were predominantly in Institutions, partially offset by net inflows to Private Wealth. There were no outflows resulting from AXA S.A.'s ongoing redemption of certain low-fee fixed income mandates. Year-to-date through September, these redemptions amounted to approximately $11.1B of the total expected redemptions of $14B.
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DIS | Hot Stocks16:18 EDT Disney says reorganization in light of 'tremendous success' of Disney+
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ETH | Hot Stocks16:18 EDT Ethan Allen jumps 14% to $17.88 after Q1 guidance tops estimates
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DIS | Hot Stocks16:17 EDT Disney reorganizes businesses with more focus on DTC strategy - Disney announced a strategic reorganization of its media and entertainment businesses. Under the new structure, Disney's creative engines will focus on developing and producing original content for the company's streaming services, as well as for legacy platforms, while distribution and commercialization activities will be centralized into a single, global Media and Entertainment Distribution organization. The new Media and Entertainment Distribution group will be responsible for all monetization of content-both distribution and ad sales-and will oversee operations of the company's streaming services. It will also have sole P&L accountability for Disney's media and entertainment businesses. The creation of content will be managed in three distinct groups-Studios, General Entertainment, and Sports-headed by current leaders Alan F. Horn and Alan Bergman, Peter Rice, and James Pitaro. The Media and Entertainment Distribution group will be headed by Kareem Daniel, formerly President, Consumer Products, Games and Publishing. All five leaders will report directly to Bob Chapek, Chief Executive Officer, The Walt Disney Company. Disney Parks, Experiences and Products will continue to operate under its existing structure, led by Josh D'Amaro, Chairman, Disney Parks, Experiences and Products, who continues to report to Mr. Chapek. Rebecca Campbell will serve as Chairman, International Operations and Direct-to-Consumer. Bob Iger, in his role as Executive Chairman, will continue to direct the company's creative endeavors. Under the new structure, the Company's three content groups will be responsible and accountable for producing and delivering content for theatrical, linear and streaming, with the primary focus being the Company's streaming services. Horn and Bergman will serve as Chairmen, Studios Content, which will focus on creating branded theatrical and episodic content based on the company's powerhouse franchises for theatrical exhibition, Disney+ and the company's other streaming services. The group will include the content engines of The Walt Disney Studios, including Disney live action and Walt Disney Animation Studios, Pixar Animation Studios, Marvel Studios, Lucasfilm, 20th Century Studios and Searchlight Pictures. Rice will serve as Chairman, General Entertainment Content, which will focus on creating general entertainment episodic and original long-form content for the Company's streaming platforms and its cable and broadcast networks. The group will include the content engines of 20th Television, ABC Signature and Touchstone Television; ABC News; Disney Channels; Freeform; FX; and National Geographic. Pitaro will serve as Chairman, ESPN and Sports Content, which will focus on ESPN's live sports programming, as well as sports news and original and non-scripted sports-related content, for the cable channels, ESPN+, and ABC. With the reorganization, the Direct-to-Consumer and International business will no longer be managed on a combined basis. In Ms. Campbell's role leading international operations, she will be responsible for coordinating and integrating activities across the various business units in each market to best represent the Company's overall interests, and will report to Mr. Chapek. In her role leading direct-to-consumer operations for Disney+, Hulu and ESPN+, she will report to Mr. Daniel. The new structure is effective immediately, and the Company expects to transition to financial reporting under this structure in the first quarter of fiscal 2021.
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AMK | Hot Stocks16:17 EDT AssetMark Financial reports platform assets $67.3B at the end of Sept., up 16.2% - AssetMark Financial reports September-end platform assets of $67.3B, up 16.2% year-over-year. Net flows were $349M in the month of September, up 11.9% year-over-year. In the third quarter, net flows totaled $1.2B.
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IVZ | Hot Stocks16:16 EDT Invesco reports preliminary AUM $1.218T as of September 30 - A decrease of 2.2% versus previous month-end. Total net outflows were $0.7B. The firm achieved net long-term inflows of $1.4B this month.
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XGN | Hot Stocks16:15 EDT Exagen provides data evaluating 'economic benefits AVISE Lupus testing' - Exagen announced the publication of a study evaluating the economic benefits AVISE Lupus testing, titled "Evaluation of the Economic Benefit of Earlier Systemic Lupus Erythematosus, SLE, Diagnosis using a Multivariate Assay Panel in ACR Open Rheumatology. Lead author Dr. Ann Clarke, Professor and Arthritis Society Chair in Rheumatic Diseases at the Cumming School of Medicine, University of Calgary, stated, "It is widely known there are varying limitations to the decades-old standard diagnostic tests for SLE, and these findings support the clinical need for an improved SLE diagnostic test." Over the four-year time horizon AVISE Lupus demonstrated an estimated total direct cost savings of $1,991,152, or $1,991 per patient Year 1 savings of $655,403, or $655 per eligible patient, with the use of AVISE(R) Lupus, which aligns with early benefit to health plans looking for savings in the first year "We are proud to provide in collaboration with leading health economic experts the first ever published data demonstrating the economic benefit of AVISE(R) Lupus compared to SDLTs," said Ron Rocca, President and CEO of Exagen. "Patients suffering from SLE face significant health disparities, and it is well established that earlier diagnosis often leads to improved patient outcomes. This study quantifies the added economic benefit of early intervention in the treatment of this hard-to-diagnose disease."
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ETH | Hot Stocks16:15 EDT Ethan Allen says Q1 retail segment written orders up 10.8% y/y - Retail segment written orders continued to accelerate with growth of 10.8% over the prior year. Wholesale segment orders, while benefitting from the strong retail growth, were down 0.4% due to the timing of GSA and other government orders that were negatively impacted by COVID-19 pandemic related disruptions. Excluding GSA and other government orders, Wholesale segment orders booked were up 9.2% for the quarter.
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ETH | Hot Stocks16:13 EDT Ethan Allen CEO says 'our fundamentals remain strong' - Farooq Kathwari, Ethan Allen's Chairman, President and CEO commented, "Our fundamentals remain strong. Retail written orders and backlogs continue to grow, with significant growth both in our design centers and from our e-commerce business. With our manufacturing production now reaching pre-COVID-19 levels, we are increasing capacity and production. Our unique vertical structure, whereby we produce about 75% of what we sell, mostly on a custom made-to-order basis in our own North American manufacturing plants, allows us to maintain stronger service levels with greater control over inventory. We plan to continue our marketing efforts and are well positioned to grow with our relevant offerings as well as our complimentary personal interior design service combined with technology and in-home white-glove delivery."
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ETH | Hot Stocks16:13 EDT Ethan Allen sees Q1 consolidated gross margin of 56.8%
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SP | Hot Stocks16:12 EDT SP Plus appoints Colleen Kozak as CHRO - SP Plus announced the appointment of Colleen Kozak as chief human resources officer, or CHRO, where she now serves as a member of the company's executive team, reporting directly to Marc Baumann, CEO. She replaces Gerry Klaisle, who is transitioning from his position as chief administrative officer prior to his retirement at the end of the year. Kozak joined the company in 2015, as VP, human resources and holds 25 years of experience. Prior to joining SP+, she was the Head of HR for retail stores at Sears.
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ATNX | Hot Stocks16:11 EDT Axis Therapeutics, a n Athenex and XLifeSc JV, in pact with h PharmaEssentia - Axis Therapeutics , a joint venture between Athenex and Xiangxue Life Sciences Limited, XLifeSc, announced that it has entered into a research collaboration with PharmaEssentia. The collaboration involves the development of T Cell Receptor, TCR-T therapy in Taiwan. Under the terms of the agreement, Axis Therapeutics and PharmaEssentia will collaborate to conduct an initial clinical study of Axis Therapeutics' TCRT-ESO-A2 therapy, targeting solid tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients, and to manufacture the investigational products, in Taiwan. PharmaEssentia will be responsible for all activities relating to the clinical development in Taiwan. Athenex recently announced that the U.S. Food and Drug Administration, FDA, has allowed the Investigational New Drug, mIND, application for this same compound. Dr. Johnson Lau, CEO of Athenex, and CEO of Axis Therapeutics, stated, "PharmaEssentia represents an important long-term partner of Athenex. We are excited to expand our relationship beyond the Orascovery and Src Kinase platforms to include a collaboration with Axis Therapeutics for the development of TCR-T therapy. We look forward to collaborating with PharmaEssentia on the development of this novel T-cell technology in Taiwan." Dr. Daniel Lang, President of Axis Therapeutics, added, "The agreement expands the longstanding relationship between Athenex and PharmaEssentia. We are excited to work with such a trusted partner to further advance our TCR-T therapy."
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PSN | Hot Stocks16:11 EDT Parsons selected by SCRRA as one of five firms for 3-year, $50M task order - Parsons Corporation announced that the company has been selected by the Southern California Regional Rail Authority as one of five engineering firms for a three-year $50M task order contract. Parsons will support an unprecedented plan for expansion, rehabilitation and state of good repair projects that will improve the safety and service of the Metrolink System and its facilities. "The Metrolink System is continually optimizing its network, which connects six Southern California counties to provide safe, seamless and reliable transportation," said Tom Topolski, executive vice president, connected communities market for Parsons. "With deep roots in California, Parsons will utilize our extensive expertise in railroad project management, design, and construction management to support SCRRA as they expand and improve their system to better connect riders to the community."
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VCTR | Hot Stocks16:11 EDT Victory Capital reports September AUM $132.7B vs. $136.8B in prior month
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LPLA BAC | Hot Stocks16:09 EDT LPL Financial announces Thomas Cappello as chief risk officer - LPL Financial (LPLA) announced that Thomas Cappello has joined the firm as executive VP and chief risk officer, effective immediately. In his new role, Cappello is responsible for LPL's risk functions, including enterprise risk management, business risk management and product risk management. He reports to Michelle Oroschakoff, LPL managing director and chief legal officer and is based at the firm's Carolinas location. Cappello joins LPL from Bank of America (BAC), where he served as managing director, enterprise strategic risk executive and chief risk officer for the investment solutions group. In this role, he was responsible for providing risk oversight of key priorities across Bank of America, as well as material risks related to investment advice, strategy and products across Merrill Lynch and Bank of America Private Bank.
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HSTM | Hot Stocks16:06 EDT HealthStream acquires ShiftWizard for $32M in cash - HealthStream announced that it has acquired ShiftWizard, a Raleigh, North Carolina-based company focused on providing a SaaS-based solution that integrates key workforce management capabilities, including scheduling, productivity, and forecasting. HealthStream acquired ShiftWizard, Inc. for approximately $32.0M in cash, subject to working capital and other customary purchase price adjustments.
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MN | Hot Stocks16:06 EDT Manning & Napier reports preliminary AUM $19.2B as of September 30 - Which included approximately $13.6B in separately managed accounts and approximately $5.6B in mutual funds and collective investment trusts.
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VYGR | Hot Stocks16:04 EDT Voyager Therapeutics provides update on VY-HTT01 IND - Voyager Therapeutics announced that it has received feedback from the FDA on the investigational new drug, or IND, submission for VY-HTT01 for the treatment of Huntington's disease. Voyager submitted the IND for VY-HTT01 in September and has been notified that the IND was placed on clinical hold pending the resolution of certain chemistry, manufacturing and controls, or CMC, matters. The company expects to receive specific feedback from the FDA on these matters within 30 days and plans to work closely with the agency to resolve them and promptly begin the clinical evaluation of VY-HTT01.
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IVA | Hot Stocks16:02 EDT Inventiva receives breakthrough therapy designation for lanifibranor from FDA - Inventiva announced that the FDA has granted breakthrough therapy designation to lanifibranor, the company's lead drug candidate, for the treatment of NASH. The company said lanifibranor is believed to be the first drug candidate to be granted this status for the treatment of NASH since January 2015.
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MCC | Hot Stocks14:04 EDT Medley Capital trading resumes
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MDLY | Hot Stocks13:52 EDT Medley Management 'not aware' of any material change in business, operations - Medley Management is issuing s press release in light of unusual trading activity related to the common shares of the Company. The company said, "While the Company does not normally comment on market activity, the Company confirms that it is not aware of any undisclosed material change in the business, operations or affairs of the Company that would account for the recent increase in trading activity, and related increase in trading price."
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BRG | Hot Stocks13:32 EDT Bluerock Residential reports preliminary Q3 multifamily rent collections of 97% - Bluerock Residential Growth REIT provided a third quarter update on rent collections and occupancy. On a preliminary basis, for the third quarter of 2020, the company reported rent collections from its multifamily properties of 97%, including payment plans of 1%. The company's operating portfolio occupancy at September 30, 2020 was approximately 95.1%. "The company's continued stability is attributable to several factors, including the focus on knowledge economy markets, primarily in the south and west: the strategy to own Class A affordable luxury apartment communities; and a tenancy targeted towards knowledge economy renters by choice, including those employed in health care, technology, education, sciences, and finance, a demographic often characterized by healthier, more stable, wage-to-rent ratios," Bluerock stated.
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LIVN | Hot Stocks13:09 EDT PrimeStone Capital sends letter to LivaNova, says shares reach $100 - PrimeStone Capital, a 2.2% stakeholder in LivaNova, disclosed this morning a public letter to the sent to the company's board. The letter reads in part: "Our work has led us to believe that LivaNova holds attractive assets and that its shares are significantly undervalued versus their full potential due to the combination of a misconceived strategy and poor execution. We think that its share price can more than double to $100. However, to get there, several changes need to take place and our recent discussions have led us to conclude that the appropriate next step is to share our diagnosis and recommendations more broadly for the benefit of all stakeholders. Doing so will enable the Company to better gauge investors' and analysts' perspectives on these matters. Given the conversations we have had with some of them, we have little doubt that our suggestions will be met with support." Capital allocation, transparency, governance and leadership are areas PrimeStone wants the company to address. Reference Link
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TSLA | Hot Stocks12:07 EDT S&P raises issuer credit rating on Tesla to 'BB-' from 'B+' - S&P Global Ratings raised its issuer credit rating on Tesla to "BB-" from "B+" and raised its issue-level ratings on its unsecured debt to "BB-" from "B+," stating "improved execution, increasingly efficient production, and global expansion continue to strengthen the company's competitive position." S&P added: "The stable outlook reflects our view that Tesla's financial performance will stay in line with our expectations, namely: a weighted free operating cash flow to debt ratio above 5%, even as it expands its manufacturing footprint around the world."
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VEDL | Hot Stocks12:00 EDT Vedanta falls -10.7% - Vedanta is down -10.7%, or -64c to $5.32.
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MN | Hot Stocks12:00 EDT Manning & Napier falls -12.4% - Manning & Napier is down -12.4%, or -58c to $4.07.
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SOL | Hot Stocks12:00 EDT ReneSola falls -19.6% - ReneSola is down -19.6%, or -81c to $3.33.
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IH | Hot Stocks12:00 EDT iHuman rises 23.2% - iHuman is up 23.2%, or $3.71 to $19.71.
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DDS | Hot Stocks12:00 EDT Dillard's rises 32.0% - Dillard's is up 32.0%, or $13.48 to $55.56.
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ATV | Hot Stocks12:00 EDT Acorn International rises 36.8% - Acorn International is up 36.8%, or $5.55 to $20.62.
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FB | Hot Stocks10:38 EDT Facebook to ban Holocaust denial content - In a blog post, Monika Bickert, VP of content policy, said, "We are updating our hate speech policy to prohibit any content that denies or distorts the Holocaust. Organizations that study trends in hate speech are reporting increases in online attacks against many groups worldwide, and we continue our efforts to remove it. We have banned more than 250 white supremacist organizations and updated our policies to address militia groups and QAnon. We also routinely ban other individuals and organizations globally, and we took down 22.5 million pieces of hate speech from our platform in the second quarter of this year. Following a year of consultation with external experts, we recently banned anti-Semitic stereotypes about the collective power of Jews that often depicts them running the world or its major institutions. Today's announcement marks another step in our effort to fight hate on our services. Our decision is supported by the well-documented rise in anti-Semitism globally and the alarming level of ignorance about the Holocaust, especially among young people. According to a recent survey of adults in the US aged 18-39, almost a quarter said they believed the Holocaust was a myth, that it had been exaggerated or they weren't sure...Beginning later this year, we will direct anyone to credible information off Facebook if they search for terms associated with the Holocaust or its denial on our platform." Reference Link
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WEX | Hot Stocks10:04 EDT WEX Inc. trading resumes
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LUV | Hot Stocks10:03 EDT Southwest, Stanford University School of Medicine partner for Southwest Promise - Southwest Airlines is working with the Stanford University School of Medicine to review the carrier's multi-layered approach to supporting the well-being of Customers and Employees during the ongoing COVID-19 pandemic. The Southwest Promise encompasses the changes the airline has made to its around-the-clock operations, cleaning procedures, and physical-distancing measures, and representatives from Stanford Medicine will now offer medical advice and protocol recommendations to guide the airline's ongoing and future efforts during the pandemic. As part of the collaboration, Southwest will have access to an advisory council comprised of Stanford Medicine's physician-scientists with knowledge and expertise in infectious diseases, prevention and testing protocols, and the latest medical research about COVID-19. This advisory council will provide insights to support Southwest's commitment to keeping Safety as an uncompromising priority.
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HUYA | Hot Stocks10:00 EDT Huya falls -9.7% - Huya is down -9.7%, or -$2.51 to $23.28.
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VEDL | Hot Stocks10:00 EDT Vedanta falls -10.6% - Vedanta is down -10.6%, or -63c to $5.33.
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SOL | Hot Stocks10:00 EDT ReneSola falls -13.8% - ReneSola is down -13.8%, or -57c to $3.58.
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MCC | Hot Stocks10:00 EDT Medley Capital rises 12.9% - Medley Capital is up 12.9%, or $2.51 to $22.00.
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DDS | Hot Stocks10:00 EDT Dillard's rises 24.0% - Dillard's is up 24.0%, or $10.11 to $52.19.
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ATV | Hot Stocks10:00 EDT Acorn International rises 35.8% - Acorn International is up 35.8%, or $5.39 to $20.47.
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MCS... | Hot Stocks09:54 EDT Stephen King feels terrible for industry after seeing first movie in months - Author Stephen King said yesterday on Twitter: "I went to the movies last night. First time since February. No problem social distancing. Saturday night, 7 screens, 4 total customers including me and my nephew. I feel terrible for the film industry." Publicly traded companies in the movie space include AMC Entertainment (AMC), Cinemark (CNK), Cineworld Group (CNNWF), Imax (IMAX), Marcus (MCS) and National CineMedia (NCMI).
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MCC | Hot Stocks09:47 EDT Medley Capital trading halted, news pending
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IPOB | Hot Stocks09:47 EDT Social Capital Hedosophia Holdings II rises 12.3% - Social Capital Hedosophia Holdings II is up 12.3%, or $2.61 to $23.85.
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DDS | Hot Stocks09:47 EDT Dillard's rises 19.5% - Dillard's is up 19.5%, or $8.21 to $50.29.
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ATV | Hot Stocks09:47 EDT Acorn International rises 33.3% - Acorn International is up 33.3%, or $5.03 to $20.10.
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WEX | Hot Stocks09:38 EDT Wex 'pleased' with England High Court Issues Hearing outcome - Wex is "pleased with the outcome" of the Preliminary Issues Hearing relating to the May 11 lawsuit filed by eNett and Optal denying that there has been a Material Adverse Effect on their businesses, in the High Court of Justice of England and Wales in the United Kingdom. Melissa Smith, Wex's Chair and CEO commented, "We are very pleased with the court's positive ruling in our favor. This upholds WEX's position that in the context of the Material Adverse Effect Clause, eNett and Optal operate in the B2B Payments Industry. We believe this ruling supports our determination that they have been disproportionately impacted by COVID-19 and WEX is not required to close the transaction as we stated in May." The trial of preliminary issues has concluded, among other things, that for the purposes of the Material Adverse Effect clause in the purchase agreement, eNett and Optal operate in the B2B payments industry with numerous other well-known participants, and that when determining whether eNett or Optal have been disproportionately impacted by COVID-19, a comparison will be made against these other B2B payments companies, the company said in a statement. It added, "Although there is a possibility that the decision will be appealed, Wex remains confident in its belief that eNett and Optal have been and are disproportionately impacted, and that Wex is not required to close the transaction pursuant to the terms of the purchase agreement because of this Material Adverse Effect. This matter will be decided conclusively at a subsequent trial."
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NET | Hot Stocks09:34 EDT Cloudflare spikes higher after announcing Cloudflare One - Cloudflare moves up 8% or $3.70 per share to 49.97 per share after announcing the company released Cloudflare One, "a comprehensive, cloud-based network-as-a-service solution for your workforce," "As more businesses rely on the Internet to operate, Cloudflare One protects and accelerates the performance of devices, applications, and entire networks to keep workforces secure. Now businesses can protect their workforce in a flexible and scalable way, without compromising security as distributed teams work from multiple devices and personal networks. "After decades of building legacy corporate networks, organizations are left with clunky systems designed to protect their now empty offices. The only way to secure today's work-from-anywhere economy is to secure each individual employee, protecting their individual networks, devices, and access to business-critical applications," said Matthew Prince, co-founder and CEO of Cloudflare. "With Cloudflare One, we're giving organizations of any size the power to solve their security and networking needs seamlessly, no matter how their business needs shift," noted the company.
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CTVA ON | Hot Stocks09:33 EDT Starboard sees upside in shares of Corteva and ON Semiconductor - Starboard Value pitched Corteva (CTVA) and ON Semiconductor (ON) as long ideas Friday at the 2020 Active-Passive Investor Summit. Corteva can create "substantial value for shareholders through improved operational execution, which will inspire greater confidence from shareholders, and lead to an improved valuation multiple," Starboard wrote in its presentation. A year-end 2021 price target at the current multiple is $47 while a year-end 2021 target at the high end of peers' multiple yields a $55 share price, Starboard wrote. Corteva closed Friday at $33.43. The firm believes ON "represents a compelling investment opportunity" due to attractive end markets, long product life cycles, the ability to expand margins, industry consultation and an attractive valuation. Semi industry consolidation will continue and ON is "uniquely positioned as a scaled asset trading at a discount," says Starboard.
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JPM | Hot Stocks09:32 EDT Chase First Banking announces new checking account designed for kids - Launching today, Chase First Banking is a new checking account with no monthly fees designed to help parents teach kids and teens about the importance of money management through the Chase Mobile app. The account was built by Chase in collaboration with Greenlight-a company on a mission to help parents raise financially smart kids. Exclusively for Chase retail deposit account customers, Chase First Banking accounts can be opened for free by parents, adult family members and legal guardians through their Chase Mobile app. Chase has over 54 million digitally active and 39 million mobile active customers. To learn more, including videos on how it works, visit Chase.com/FirstBanking starting today, or visit a Chase branch. In addition to Chase First Banking, the bank also offers checking and savings accounts for high school and college-aged youth.
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WEX | Hot Stocks09:29 EDT WEX Inc. trading halted, news pending
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CCL CUK | Hot Stocks09:26 EDT Carnival cancels Miami, Port Canaveral cruises for November - Carnival Cruise Line has notified guests and travel agents that it is cancelling the remaining cruises for the six total ships operating from PortMiami and Port Canaveral for November, 2020. It has also cancelled five cruises scheduled to operate from Sydney, Australia from Jan. 16 - Feb. 8, 2021. Following the U.S. Centers for Disease Control's decision to extend its no-sail order for cruise operations until Oct. 31, Carnival cancelled all but PortMiami and Port Canaveral cruises for the rest of the year. It has now determined that November 2020 operations will not be feasible. Carnival continues to work on protocols and procedures that would allow for the resumption of cruise operations, with a gradual, phased-in approach, designating Miami and Port Canaveral as the first two homeports for embarkations. Cruises currently scheduled for December from those two homeports remain in place for the time being while Carnival evaluates options. However, guests booked on cruises in December out of Miami and Port Canaveral still have the ability to voluntarily cancel their reservation and receive the same offer that all other impacted guests are receiving, which includes a combination future cruise credit and onboard credit, or a full refund. In Australia, Carnival is notifying guests and travel agents that five cruises on Carnival Splendor from Jan. 16 - Feb. 8, 2021 have been cancelled. Those guests will receive the same offer of the combination FCC/OBC, or a full refund.
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GILD GLPG | Hot Stocks09:23 EDT Gilead and Galapagos present data on filgotinib for UC treatment at UEGW - Gilead Sciences (GILD) and Galapagos (GLPG) presented late-breaking data demonstrating sustained efficacy and safety with filgotinib, an investigational, oral, once-daily, JAK1 preferential inhibitor, for the treatment of moderately to severely active ulcerative colitis, UC. The data from the randomized, double-blind, placebo-controlled, Phase 2b/3 SELECTION trial showed that a significantly igher proportion of patients treated with filgotinib 200 mg, versus placebo, achieved clinical remission at Week 10 and maintained remission through Week 58. In addition, significantly more patients achieved six-month corticosteroid-free remission. The full results were presented at the 2020 United European Gastroenterology Week, UEGW, Virtual Meeting.
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ZYXI | Hot Stocks09:21 EDT Zynex CEO: Order growth slightly lower than what we originally projected for Q3 - Thomas Sandgaard, CEO of Zynex said: "Similar to most companies we have seen the impact of the COVID-19 pandemic, not only on the availability of physicians to prescribe our products but also on navigating employee and supply chain issues. Our order growth during this pandemic has been encouraging with 96% growth year over year and 87% sequentially but was slightly lower than what we originally projected for Q3. During Q3, we continued to aggressively hire sales reps as we eclipsed 400 sales reps in early September. We expect to have approximately 500 sales reps in the U.S. by the end of 2020 and over 600 by the end of 2021."
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GILD GLPG | Hot Stocks09:20 EDT Gilead, Galapagos presents data from Phase 2b/3 trial of filgotinib - Gilead Sciences (GILD) and Galapagos (GLPG) presented late-breaking data demonstrating sustained efficacy and safety with filgotinib, an investigational, oral, once-daily, JAK1 preferential inhibitor, for the treatment of moderately to severely active ulcerative colitis. The data from the randomized, double-blind, placebo-controlled, Phase 2b/3 SELECTION trial showed that a significantly higher proportion of patients treated with filgotinib 200 mg, versus placebo, achieved clinical remission at Week 10 and maintained remission through Week 58. In addition, significantly more patients achieved six-month corticosteroid-free remission. The full results were presented today at the 2020 United European Gastroenterology Week Virtual Meeting. UC is a longer-term condition characterized by inflammation of the mucosal lining of the colon and rectum. An increasingly prevalent disease, UC has a significant impact on the quality of life of more than 2 million people around the world. Despite current treatments, many patients experience fecal urgency, incontinence, recurring bloody diarrhea, and the need to empty their bowels frequently, often accompanied by abdominal pain, poor sleep and fatigue. The SELECTION study included biologic-naive patients, for whom prior conventional therapy had failed, as well as biologic-experienced patients, a high proportion of whom had been non-responders to at least two different lines of prior biologics. In total, 43 percent of patients in the biologic-experienced cohort had failed treatment with both a TNF inhibitor and vedolizumab. The study allowed the enrollment of patients who were taking steroids, and/or immunomodulators, including methotrexate, mercaptopurine or azathioprine, as they would in real-world clinical practice. Overall, 1,348 biologic-naive or biologic-experienced adult patients with moderately to severely active UC were randomized and treated in the SELECTION study. Among biologic-naive patients treated with filgotinib 200 mg, a significantly higher proportion of patients achieved clinical remission at Week 10 compared with placebo. Additionally, a significantly higher proportion of biologic-naive patients treated with filgotinib 200 mg versus placebo achieved Mayo Clinic Score remission, endoscopic remission and histologic remission. A significantly higher proportion of biologic-experienced patients treated with filgotinib 200mg achieved clinical remission at Week 10 compared with placebo. Patients treated with filgotinib who achieved clinical response or remission at Week 10 were re-randomized to their induction dose of filgotinib or placebo in a 2:1 ratio and treated through Week 58. At Week 58, 37.2 percent of patients receiving filgotinib 200 mg achieved clinical remission, compared with 11.2 percent of patients treated with placebo. A significantly higher proportion of those treated with filgotinib 200 mg versus placebo achieved sustained clinical remission, MCS remission, endoscopic remission and histologic remission. Additionally, a significantly higher proportion of patients treated with filgotinib 200 mg achieved six-month corticosteroid-free clinical remission at Week 58 compared with placebo. Overall, the incidence of adverse events, serious AEs and discontinuations due to AEs were similar in the filgotinib and placebo groups in both the induction and maintenance periods of the study. Serious infections, herpes zoster, venous thrombosis, pulmonary embolism and gastrointestinal perforation were infrequent and comparable across treatment groups. The most common adverse events of interest in the induction trials were serious infections, herpes zoster, opportunistic infections and pulmonary embolism. In the maintenance trial, the most common adverse events of interest were serious infections, herpes zoster and venous thrombosis. Two deaths were observed in the filgotinib 200 mg treatment group in the maintenance trial; both adverse events leading to deaths were considered by the study investigators to be unrelated to study drug.
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BBQ | Hot Stocks09:12 EDT Famous Dave's signs 25-unit development deal to grow BBQ brand - Famous Dave's recently signed a 25-unit development agreement to grow the BBQ brand in select locations across the U.S., adding to its 125 existing locations. The BBQ franchise is partnering with Bluestone Hospitality Group to open both Famous Dave's ghost kitchens and dual restaurant concepts with the group's Italian brand, Johnny Carino's. Famous Dave's of America is a wholly owned subsidiary of BBQ Holdings.
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APPN VWAGY | Hot Stocks09:10 EDT Volkswagen Group of America deploys Appian workforce safety solution - Appian (APPN) announced that Volkswagen Group of America is using Appian's Workforce Safety solution to automate the process of helping manage the safe and healthy return of the majority of its U.S. workforce to the workplace in phases, and in accordance with local health conditions. The solution, built on the Appian Low-code Automation Platform, enables Volkswagen to manage the complexities of the workplace return, including prioritizing workforce health and workplace safety. Volkswagen Group of America is the North American operational headquarters and a subsidiary of Volkswagen AG (VWAGY).
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LHX | Hot Stocks09:08 EDT L3Harris to develop defense satellite system for Space Development Agency - L3Harris Technologies will develop and integrate an end-to-end satellite system under a $193M firm fixed-price contract for the Space Development Agency. L3Harris will support the agency with technology that will protect against advanced missiles, such as hypersonic. "L3Harris has brought a different perspective to this mission including our experience as a responsive space prime and decades of electro-optical and infrared payload development," said Ed Zoiss, President, Space and Airborne Systems, L3Harris. "We understand the mission and the need to move quickly, which we're able to do by drawing capabilities from across the company." L3Harris is prioritizing investments in end-to-end satellite solutions in spacecraft, payloads, ground software and advanced algorithms. L3Harris also supports the Missile Defense Agency's Hypersonic and Ballistic Tracking Space Sensor and the U.S. Space Force's Overhead Persistent Infrared Satellite Program.
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GLBS | Hot Stocks09:08 EDT Globus Maritime announces acquisition of Kamsarmax vessel for $18.4M - Globus Maritime announced that it has entered into, through a separate wholly owned subsidiary, an agreement with an unaffiliated third party to purchase a 2015-built Kamsarmax vessel built by the Hudong-Zhonghua Shipbuilding shipyard, for $18.4M. The vessel is expected to be delivered to Globus during the fourth quarter of 2020. On completion of this acquisition, the fleet of Globus will expand to six modern dry bulk carriers with a total carrying capacity of 381,738 deadweight tons and a weighted average age of 10.9 years.
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QLYS | Hot Stocks09:07 EDT Qualys expands into China, partners with Digital China - Qualys announced it is expanding into China through the establishment of a Private Cloud Platform and a partnership with Digital China, the largest value-added provider of integrated IT products, solutions and support for enterprises in China. Digital China will manage and support the Qualys Private Cloud Platform from China and distribute and resell Qualys' leading cloud-based IT, security and compliance solutions.
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BEN | Hot Stocks09:06 EDT Franklin Resources reports preliminary AUM of $1.42B as of August 31 - Franklin Resources reported preliminary month-end assets under management of $1,418.9B at September 30, compared to $1,441.3B at August 31, 2020.
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ICLK | Hot Stocks09:05 EDT iClick Interactive Asia increases controlling interest in Changyi - iClick Interactive Asia Group announced that it has increased its controlling interest in Changyi Information Technology Co., Ltd, an independent software vendor in China which provides intelligent retail and CRM solutions, through which iClick has further enhanced its data-driven Enterprise Solutions business. Building on its success in the China market, iClick also anticipates the synergies generated from its increased stake in Changyi will help it expand into the regional market as well, especially the ASEAN market where the company has already formed strategic partnerships with top local partners.
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LGND | Hot Stocks09:05 EDT Ligand sells Vernalis research ops, internal program to HitGen for $25M in cash - Ligand Pharmaceuticals announces the sale of Ligand's Vernalis research operations and internal programs to HitGen for $25M in cash. Under the terms of the agreement, Ligand will retain economic rights on completed collaboration licenses as well as a share of the economic rights on current research collaboration contracts. In addition, Vernalis will continue to support certain existing Ligand partnerships. The transaction is expected to close in the fourth quarter of 2020, subject to customary closing conditions. Ligand retains economic rights to a portfolio of eight fully-funded partnered programs, including RPL554, Ensifentrine, a Phase 3 novel treatment for COPD partnered with Verona Pharma, and CPI-444, Ciforadenant, a Phase 1b/2 adenosine A2A receptor antagonist for treating various cancers partnered with Corvus Pharmaceuticals. Ligand also maintains rights to a Phase 1/2 HSP90 inhibitor, which has potential application for the treatment of COVID-19.
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EVI | Hot Stocks09:04 EDT EVI Industries to acquire Yankee Equipment Systems for $13.5M in cash, stock - EVI Industries announced that it executed a definitive merger agreement to acquire Barrington, New Hampshire based Yankee Equipment Systems, a distributor of commercial laundry products and a provider of related technical installation and maintenance services. Yankee Equipment Systems is led by Peter Limoncelli. The company said this acquisition complements other EVI acquisitions completed in 2019, including the purchase of PAC Industries and Professional Laundry Systems. Limoncelli will also be named the president of EVI's Northeast Operations, which will consist of the operations of Yankee Equipment Systems, PAC Industries, and Professional Laundry Systems and include a combined 120 commercial laundry professionals serving customers throughout the region. The consideration to be paid by EVI in connection with this acquisition is $13.5M, which consistent with EVI's historical transactions, will be paid in a combination of cash and EVI common stock. The transaction is expected to close upon the satisfaction of closing conditions.
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HON | Hot Stocks09:03 EDT Honeywell awarded repair, overhaul contract for U.S. Army Chinook fleet - Honeywell has won a five-year IDIQ contract for the repair and overhaul of its T55-GA-714A engines that operate on the U.S. Army's CH-47 Chinook helicopters. This contract award will ensure that the U.S. Army's Chinook fleet has spare engines to sustain its future missions and overall readiness. The engines will be serviced at Honeywell's new maintenance facility at the company's Aerospace global headquarters in Phoenix.
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ABT | Hot Stocks09:01 EDT Abbott receives FDA Emergency Use Authorization for COVID-19 IgM antibody test - Abbott announced that the U.S. FDA issued Emergency Use Authorization for the company's AdviseDx SARS-CoV-2 IgM lab-based serology test for use on the ARCHITECT and Alinity platforms. IgM antibody testing can play an important role in understanding if someone has developed antibodies in response to the virus, indicating a recent or prior infection. The new IgM antibody test is Abbott's latest test to support in the fight against COVID-19. Since the start of the pandemic, Abbott has received emergency use authorization for seven tests, including molecular tests, a rapid antigen test and an IgG antibody test.
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CNDT | Hot Stocks08:47 EDT Social Security Administration renews Conduent's blanket purchase agreement - Conduent announced the award of a blanket purchase agreement from the Social Security Administration to provide automated mailroom technology that improves the efficiency of disability claims processing for millions of Americans in need. The award extends Conduent's support to the federal government, helping agencies keep pace with increasing volumes and compliance mandates while reducing costs to better serve constituents. The SSA blanket purchase agreement, which includes options to extend until 2025, marks a continuation of services Conduent has provided to the agency since 2003. From facilities primarily in Kentucky and Utah, the company uses technology to scan, review and process an average of 570,000 pages every day for beneficiaries and applicants of SSA. The agency depends on Conduent for a near-perfect 99.9 percent accuracy rate on documents scanned.
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BNED | Hot Stocks08:43 EDT Barnes & Noble College introduce custom-branded version of First Day Complete - Barnes & Noble College announced it has partnered with Sam Houston State University in Huntsville, Texas, to introduce the Bearkat Bundle, a new course material delivery model that will drive affordability, access and convenience for students. The Bearkat Bundle is a custom-branded version of the Barnes & Noble College First Day Complete program. First Day Complete addresses affordability and equitable access across all courses at an institution by bundling the cost of materials into a flat rate fee for all students. The program results in a 35% to 50% average reduction in cost to students, and ensures they have all of their materials for the semester available to them before the first day of class. In addition, First Day Complete fully supports academic freedom and faculty choice. Faculty members can choose the materials that are best suited for their teaching, regardless of publisher or format.
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ONCS | Hot Stocks08:36 EDT OncoSec names Sandra Aung, Ph.D. as Chief Clinical Development Officer - OncoSec Medical announced that Sandra Aung, Ph.D. joined the company as Senior Vice President, Chief Clinical Development Officer. Dr. Aung will be responsible for overseeing KEYNOTE-695, the company's Phase 2b trial evaluating intratumoral delivery of its interleukin-12 based immunotherapy, TAVO, in combination with intravenous KEYTRUDA in patients with unresectable, advanced melanoma, as well as overseeing OncoSec's additional clinical trials evaluating TAVO.
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ALXN | Hot Stocks08:35 EDT Alexion gets FDA Aaproval for Ultomoris - Alexion Pharmaceuticals announced the U.S. Food and Drug Administration, FDA, has approved ULTOMIRIS, ravulizumab-cwvz, 100 mg/mL formulation for the treatment of adults with paroxysmal nocturnal hemoglobinuria, PNH, and for atypical hemolytic uremic syndrome, aHUS, to inhibit complement-mediated thrombotic microangiopathy for adult and pediatric (one month of age and older) patients. ULTOMIRIS 100 mg/mL is an advancement in the treatment experience for patients with aHUS and PNH, as it reduces average annual infusion times by approximately 60 percent compared to ULTOMIRIS 10 mg/mL while delivering comparable safety and efficacy. With ULTOMIRIS 100 mg/mL, most patients will spend six hours or less a year receiving treatment. "We have seen the significant clinical benefits ULTOMIRIS has demonstrated for patients, through its complete C5 inhibition and sustained efficacy," said Jamile Shammo, M.D., FASCP, FACP, Professor of Medicine and Pathology, Department of Internal Medicine, Rush University Medical Center. "Based on the scientific evidence presented, the advanced formulation demonstrated comparable safety and efficacy to the original formulation, with the additional benefit of significantly shorter infusion times. This reduced treatment burden is important to consider for patients, as it has the potential to make a meaningful difference in their lives." Alexion plans to make ULTOMIRIS 100 mg/mL available within a few days and has comprehensive training plans to educate all stakeholders about the new formulation. ULTOMIRIS 10 mg/mL will continue to be available until mid-2021, at which time Alexion will remove ULTOMIRIS 10 mg/mL from the market, as communicated to the FDA. The transition period is intended to provide a seamless conversion to the new formulation without interruption to patients' infusion schedules. Regulatory filings for marketing authorizations of the 100 mg/mL formulation of ULTOMIRIS are under review with regulators in the European Union and Japan. The Committee for Medicinal Products for Human Use, CHMP, has recently adopted a positive opinion, recommending marketing authorization of ULTOMIRIS 100 mg/mL in the European Union, and we anticipate receiving a decision from the European Commission in November.
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TROW | Hot Stocks08:35 EDT T. Rowe Price reports preliminary AUM $1.31T at September 30 - Client transfers from mutual funds to other portfolios, including trusts and separate accounts, were $0.5B in September, and $2.4B for the quarter-ended September 30.
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CNTY | Hot Stocks08:34 EDT Century Casinos partners with Tipico for internet sports betting in Colorado - Century Casinos announced that it has finalized an agreement with Tipico to become the company's third internet sports betting operator partner in Colorado. The company, through a subsidiary, has already obtained its master license with the State of Colorado. Tipico will complete the necessary application and approval process with the State of Colorado and will operate an internet and mobile sports betting application under the Tipico brand. The online sportsbook operations agreement with Tipico is a 10-year agreement that includes a one-time market access fee being paid to the company on contract signing, plus a minimum annual revenue guarantee and a percentage share of net gaming revenue payable to the company each year.
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GVA | Hot Stocks08:32 EDT Granite Construction awarded $16M task order by FEMA - Granite Construction announced it has been awarded a $16M task order contract by the U.S. Department of Homeland Security's Federal Emergency Management Agency, or FEMA, for the Permanent Housing Construction - New Construction for Disaster Declaration project in Saipan, CNMI. The contract will be booked into Granite's Q4 backlog. This project is part of a previously awarded U.S. Department of Homeland Security's national multiple award construction contract, or NMACC II, to construct twenty new homes, replacing those severely damaged by Super Typhoon Yutu, the strongest typhoon ever recorded to impact the Mariana Islands, and the second-strongest to strike the United States or its territories. As part of their design-build services, Granite will be responsible for all permitting, site design and construction of all the cast-in-place concrete homes. Granite has worked in Guam and the Marianas Islands since 2011. Construction is expected to begin in fall 2020 and conclude by spring 2021.
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SON | Hot Stocks08:20 EDT Sonoco to divest Europe contract packaging business for $120M - Sonoco announced it has signed an agreement to sell its Europe contract packaging business to Prairie Industries Holdings, a Wisconsin-based contract packaging and contract manufacturing firm backed by The Halifax Group for $120M in cash. The transaction is subject to normal closing requirements and is expected to be completed in the fourth quarter of 2020. Sonoco's Europe contract packaging business produced net sales of approximately $300M in 2019 and provides full-service custom packaging and supply chain management solutions to global consumer product goods companies through six contract packaging facilities in three locations and a warehouse all in Poland. The business is part of Sonoco's Display and Packaging segment and has approximately 2,600 employees. According to Howard Coker, Sonoco President and CEO, the divestiture is part of the Company's efforts to simplify its operating structure to focus on growing its core Consumer and Industrial packaging businesses. Net proceeds from the transaction are expected to be used to reduce short-term debt and further improve the Company's strong liquidity position.
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AYI | Hot Stocks08:18 EDT Acuity Brands enters strategic agreements with Violet Defense, PURO Lighting - Acuity Brands announced it has entered into strategic agreements with Violet Defense and Puro Lighting. These strategic agreements will give Acuity Brands access to Violet Defense's patented UV technology to expand its portfolio of UV disinfection products. PURO and Acuity Brands will also work together on the development of a next generation of UV lighting products. The products from Violet Defense and PURO employ a method pioneered by Violet Defense to deliver high intensity full spectrum ultraviolet light, using a pulsed xenon lamp and UV transmissive lens, in unoccupied spaces, to quickly kill bacteria and inactivate viruses. Independent clinical testing has confirmed that pulsed xenon products can substantially reduce the pathogenic bioburden. The compact size of the UV disinfection products from both companies make them unobtrusive when installed in a ceiling and easier to implement than many traditional UV solutions. Violet Defense and PURO have each been involved to date in several high-profile installations of UV disinfection products using the pulsed xenon technology.
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VAR | Hot Stocks08:16 EDT Varian receives IDE from FDA for clinical trial of FLASH therapy - Varian announced the company has received an Investigational Device Exemption from the FDA for the first-ever clinical trial of FLASH therapy, an experimental treatment modality delivering radiation therapy at ultra-high dose rates. FLASH therapy, involving ultra-high dose rates, and delivery in typically less than one second, may be over 100 times faster compared to conventional radiation therapy. The study, named FAST-01, will involve the investigational use of Varian's ProBeam particle accelerator modified to offer this advanced non-invasive treatment option for patients with cancer. Varian anticipates enrollment of the first patient in the FAST-01 Feasibility Study by the end of 2020.
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NAVI | Hot Stocks08:16 EDT Navient, members of American Federation of Teachers agree to settlement - Navient and members of the American Federation of Teachers, representing public service workers, agreed to a settlement that was approved by a U.S. District Court today. Through the agreement, Navient will help more people learn about the government's Public Service Loan Forgiveness program, including by implementing enhancements in its call center. These enhancements, along with a contribution of $2.25 million to a nonprofit organization that will provide education and student loan counseling to public service workers, resolve a lawsuit originally filed by AFT members.
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ATIF | Hot Stocks08:15 EDT ATIF collaborates with Workforce Development Board of San Bernardino County - ATIF Holdings announced that it has recently reached a collaboration arrangement with the Workforce Development Board of the San Bernardino County, California to foster local employment and reemployment. In July, ATIF established its new headquarters in the City of Rancho Cucamonga in the San Bernardino County within the Greater Los Angeles area, to expand its business to the North America market. Based on the collaboration arrangement, ATIF will recruit 100 experienced professionals with background in corporate business, marketing and financial market though the career center of San Bernardino WDB. These new talents to be recruited will actively focus on assisting ATIF to establish business relations with U.S. listed companies, and companies that are preparing to be listed on a stock exchange, in order for ATIF to provide investor relations services to these companies, such investor relations services include capital market strategic communications and various media programs. The purpose of the collaboration will also assist the San Bernardino WDB to mitigate the rising problem of unemployment during the current epidemic period, and to alleviate the financial difficulties faced by some local workers whom are no longer qualified for unemployment benefits. Additionally, ATIF is seeking licenses for providing financial services in the United States, and plans to diversify and expand its businesses into IPO underwriting, securities brokerage and asset management in the U.S market. To prepare for this, ATIF is launching a comprehensive talent recruitment program.
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NOW | Hot Stocks08:14 EDT ServiceNow becomes official workflow partner of the NBA and WNBA - The National Basketball Association, NBA, and Women's National Basketball Association, WNBA, announced a multiyear partnership that makes ServiceNow their inaugural Official Workflow Partner. ServiceNow, the company that makes work, work better, will deliver the products and technologies needed to create and streamline workflows across the NBA and WNBA. As part of the multiyear partnership, the NBA and WNBA used ServiceNow's Employee workflows to manage the complex, manual processes associated with the 2019-20 NBA Season Restart and 2020 WNBA season. ServiceNow's workflows enabled the NBA and WNBA to execute essential onboarding and health-screening processes to promote a safer environment on their campuses. This month, the NBA and WNBA safely completed seasons in Orlando and Bradenton, respectively, bringing basketball back to fans around the world amid the COVID-19 pandemic.
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NWGI | Hot Stocks08:14 EDT Newgioco Group to install up to 400 new NGoy virtual operator terminals in Italy - Newgioco Group announced that through its wholly owned subsidiary Multigioco, the company plans to install up to 400 new self-service point of sale locations throughout Italy with the launch of NGoy virtual operator terminals. The company has commenced installations with the first 100 NGoy terminals to be operational in Italy by December and an additional 300 to be installed through 2021. Additionally, the company intends to expand deployment of the NGoy terminal in other European countries that permit regulated sports betting. The Newgioco design-built kiosk, commissioned under a previously announced agreement with VNE Produzione, is a self-service terminal that allows access to player gaming accounts for remote deposits and withdrawals along with the loading and re-loading of pre-paid cards, phone cards and a variety of other banking services including bill paying features.
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RAIL | Hot Stocks08:14 EDT FreightCar America completes steps in manufacturing repositioning - FreightCar America announced that it has made significant progress in its manufacturing repositioning and business transformation strategy. Highlights: Successfully finalized early termination of the lease at Cherokee, Alabama manufacturing facility effective February 28, 2021; Completed Association of American Railroads certification audits for new joint venture facility in Castanos, Mexico and now awaiting approval to start shipping railcars; Castanos completed its first car in early September and continues to ready itself for full production in 2021; Obtained new asset-backed credit facility to facilitate the business and repositioning process going forward. FreightCar America completed an amendment to its Shoals manufacturing facility lease with the RSA. The amendment accelerates the expiration date of the lease from December 31, 2026 to February 28, 2021, which aligns with FreightCar America's decision to close the Shoals facility by the end of the first quarter of 2021. In addition, the RSA has agreed to waive the base rent payable under the original lease for the months of October 2020 through February 2021. As consideration for the early termination and rent waiver, the Company agreed to sell and transfer certain basic infrastructure at the facility to the RSA. Under the amendment, FreightCar America has the ability to store railcars and other rolling stock from the end of the term through June 30, 2021 for no additional rent or other costs. In September, AAR representatives visited Castanos as a part of the certification process for the new plant. The AAR is the world's leading railroad policy, research, standard-setting and technology organization that focuses on safety and productivity. The AAR representatives conducted two customary audits and, subject to the final documentation from the AAR, the Company expects to begin shipping railcars by the end of the year. FreightCar America recently obtained a new asset-backed credit facility with a maximum aggregate principal amount of up to $20 million, subject to a borrowing base, with Siena Lending Group as lender. The Credit Facility was used to finance certain letter of credit obligations and will provide improved working capital flexibility for the Company. This new facility replaced the Company's prior $50 million revolving credit facility with BMO Harris Bank N.A., which substantially limited the company's ability to invest in its expanding Mexico operations. The agreement has a term of three years and carries an interest rate equivalent to the Base Rate plus 3.0% per annum, but not less than 6.25%.
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GOLD | Hot Stocks08:12 EDT Bullfrog Gold signs agreements with Barrick Gold, Augusta Investments - Bullfrog Gold entered into definitive agreements with certain Barrick Gold Corporation subsidiaries and Augusta Investments in connection with the previously announced transaction pursuant to which Bullfrog will acquire rights to 1500 acres adjoining the Company's Bullfrog Gold Deposit from Barrick, and Augusta and certain individuals identified by Augusta will concurrently complete a C$22 million investment in Bullfrog. Upon completion of the Transaction, Barrick and Augusta will become significant shareholders in Bullfrog. Additionally, the Board of Directors and Management of the Company will be reconstituted upon closing such that Maryse Belanger will be appointed President, CEO and Director of the Company along with the appointment of Donald Taylor, Daniel Earle, and a Barrick nominee to the Company's Board of Directors. David Beling will remain on the Board. The Definitive Agreements formalize the terms in the binding term sheet dated September 7, 2020, and detailed in the Company's press release dated September 8, 2020. The Mineral Lease and Option to Purchase Agreement between a subsidiary of BFGC and Barrick dated March 23, 2015, as amended, has been terminated and the Barrick back-in right has been eliminated. A 2% NSR royalty granted to Barrick also decreases to a minimum 0.5% NSR royalty on certain Barrick lands already subject to royalties. Closing of the Transaction is expected to follow during the fourth quarter of 2020, subject to customary conditions, including certain government approvals and the approval of the Canadian Securities Exchange.
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GOSS | Hot Stocks08:11 EDT Gossamer Bio announces updates for GB004 program - Gossamer Bio announced multiple updates for its GB004 program. GB004 is an oral, gut-targeted HIF-1alpha stabilizer, designed to promote mucosal healing and resolve local inflammation through a non-immunosuppressive mechanism of action in patients with inflammatory bowel disease. The company presented data at the UEGW virtual week from the successful Phase 1b translational medicine study of GB004 in mild-to-moderate ulcerative colitis, or UC. The Phase 1b study evaluated safety, tolerability and pharmacokinetics over 4 weeks of treatment in patients with active UC despite treatment with 5-aminosalicylate, or 5-ASA, therapy. In addition to trends disclosed earlier this year, the presentation included newly disclosed data on the reduction of an important inflammatory biomarker in IBD, fecal calprotectin and the resolution of rectal bleeding, which is considered to be an objective measure of disease activity. GB004's differentiated mechanism of action was also highlighted in a second poster summarizing data from two pre-clinical studies. In a human monolayer assay, GB004 demonstrated superior protection of barrier integrity compared to tofacitinib, a pan-JAK inhibitor approved for the treatment of moderate-to-severe UC. In a separate mouse organoid study, GB004 induced HIF-1a-dependent genes, including barrier function genes such as Claudin 1, which were elevated in patients in the Phase 1b trial, further validating GB004's mechanism of action. Gossamer has begun screening patients in a global Phase 2 study of GB004 in patients with active ulcerative colitis despite treatment with 5-ASA. Up to 195 subjects are expected to be enrolled, randomized evenly across two dose arms of GB004 and placebo. The primary endpoint of the study is clinical remission at week 12. Patients will continue blinded treatment through week 36, after which they will have the option to roll onto an open-label extension. Additional endpoints such as mucosal healing, histologic remission, clinical response, and disease clearance also will be assessed.
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GPMT | Hot Stocks08:10 EDT Granite Point Mortgage announces internalization of management - Granite Point Mortgage Trust announced that it and its external manager, Pine River Capital Management As previously announced, Granite Point will make a one-time cash payment of $44.5M to Pine River in connection with the completion of the internalization. The internalization transaction, which was negotiated and approved by an independent committee of Granite Point's Board of Directors, is expected to be effective on December 31. At that time, the management agreement between the Company and Pine River will be terminated and Granite Point will no longer pay any management or incentive fees going forward.
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ENPH | Hot Stocks08:10 EDT Enphase Energy, Natura Living partner for commercial solar projects - Enphase Energy announced that the Company and Natura Living have joined forces on commercial solar installation projects for PepsiCo Thailand. Natura Living has selected Enphase products to strengthen its commitment to providing commercial customers with high-quality microinverter-based systems.
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UBX | Hot Stocks08:08 EDT Unity Biotechnology doses first patient in Phase 1 study of UBX1325 - UNITY Biotechnology announced that the first patient has been dosed in a Phase 1 study of UBX1325 in patients with diabetic macular edema. The Phase 1, first-in-human, open-label, single-ascending dose study is designed to evaluate the safety, tolerability and pharmacokinetics of UBX1325 in patients with advanced DME. The trial is designed to enroll approximately 15 patients, with safety and tolerability data expected in the first half of 2021. UNITY anticipates initiating a proof of concept study in the first half of 2021.
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OPI RMR | Hot Stocks08:08 EDT Office Properties names Christopher Bilotto COO - Office Properties Income Trust (OPI) announced that Christopher Bilotto has been appointed as President and Chief Operating Officer of OPI, effective January 1, 2021. Mr. Bilotto has been Vice President of OPI since 2019 and Chief Operating Officer of OPI since May 2020. Mr. Bilotto is also Senior Vice President of The RMR Group (RMR), responsible for portfolio management oversight for all office, industrial and retail properties managed by RMR as well as responsible for all development and redevelopment activities at RMR across the United States. Prior to joining RMR in 2011, Mr. Bilotto worked at General Growth Properties in various management roles. He has more than 15 years of experience working in the commercial real estate industry, specializing in asset management, leasing and development.
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ATIF | Hot Stocks08:08 EDT ATIF Holdings forms collaboration with San Bernardino WDB - ATIF Holdings announced that it has recently reached a collaboration arrangement with the Workforce Development Board of the San Bernardino County, California to foster local employment and reemployment. In July, ATIF established its new headquarters in the City of Rancho Cucamonga in San Bernardino County within the Greater Los Angeles area, to expand its business to the North America market. Based on the collaboration arrangement, ATIF will recruit 100 experienced professionals with background in corporate business, marketing and financial market though the career center of San Bernardino WDB. These new talents to be recruited will actively focus on assisting ATIF to establish business relations with U.S. listed companies, and companies that are preparing to be listed on a stock exchange, in order for ATIF to provide investor relations services to these companies, such investor relations services include capital market strategic communications and various media programs. The purpose of the collaboration will also assist the San Bernardino WDB to mitigate the rising problem of unemployment during the current epidemic period, and to alleviate the financial difficulties faced by some local workers whom are no longer qualified for unemployment benefits.
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CLSN | Hot Stocks08:07 EDT Celsion continuing to follow patients overall survival from OPTIMA study - Celsion Corporation announced that Michael Tardugno, the company's chairman, president and CEO, issued a letter to stockholders providing an update on the ongoing data analysis from its Phase III OPTIMA Study. It read, in part, "In response to the recent inquiries that we are receiving, I'd like to provide you with the following update regarding the OPTIMA Study's ongoing analysis of probable futility findings, and ThermoDox, generally. As I have indicated in earlier press announcements and conference calls, since the unblinding of the OPTIMA Study at the second preplanned interim data analysis on July 9, 2020, which was conducted after reaching the prescribed 158 patient deaths in late April 2020, Celsion continues to follow patients for overall survival. Since April 27, 2020, a total of 14 new deaths have been reported, five of which occurred since July. These deaths are reasonably in line with deaths of 3.0 per month, or 0.7 per week, that had been forecasted by our consulting statistician. We now have a total of 174 deaths in the Study from a total patient enrollment of 556. The Study's statistical plan specifies a minimum of 197 deaths for the final data analysis. At the second interim analysis by the independent Data Monitoring Committee , which covered 80% of the deaths needed for the final analysis, indicated that the OPTIMA Study had narrowly crossed the futility boundary of Hazard Ratio=0.90 with substantial uncertainty. The reported HR suggested by the Kaplan-Meier analysis was 0.903 with a p-value of 0.524. The DMC advised Celsion of its findings, leaving the decision to stop the study up to the Company. n our preliminary evaluation of the topline data, Celsion determined that we should continue to follow patients until such time as futility is either confirmed or dispelled. We based this decision on enrollment trends at study sites in China and Vietnam, among other observations, suggesting that data maturity may be at issue. Additionally, despite the Study's first interim analysis appearing to be on track for a successful outcome, we noted a timed-based change in deaths in the ThermoDoxtreatment arm suggested a proportionality issue that required further evaluation. Specifically, 16 deaths occurred in five different Asia-Pacific countries between the first and second interim analyses, and 15 of these deaths were in the ThermoDox treatment arm...Celsion feels strongly that we owe it to patients, physicians and our investors to continue examining the data from the OPTIMA Study, particularly given how surprising the recommendation was from the DMC. While the trial outcome as predicted by the second interim analysis may not change, and as unlikely as it may be, in the event we see substantial clinical benefit from the CRO and NIH analyses, we will carefully review our options with the 14 regulatory agencies under which the OPTIMA Study is being conducted. In the meantime, we are heartened by multiple requests from investigators to include ThermoDox in their own studies involving a number of clinical indications. We believe this interest in investigator-sponsored trials reflects support for the potential of ThermoDox despite the confounding findings from the OPTIMA Study second preplanned interim analysis. While we await the outcome of additional data analyses from the OPTIMA Study, we continue to enroll patients in the Phase II portion of the OVATION 2 study evaluating GEN-1 for the treatment of advanced ovarian cancer. We expect patient enrollment in this clinical trial to be completed by the end of the second quarter of 2021."
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DAC | Hot Stocks08:06 EDT Danaos repurchases 4,339,271 shares of common stock - Danaos announced it has repurchased 4,339,271 shares of its common stock for an aggregate purchase price of $31.1M in privately negotiated transactions, including 2,517,013 shares from the Royal Bank of Scotland and 1,822,258 shares from Sphinx Investment Corp. These transactions will result in the company's previously announced share repurchase program being terminated.
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AZN | Hot Stocks08:06 EDT U.S. expands collaboration with AstraZeneca for COVID-19 monoclonal antibody - The U.S. Department of Health and Human Services and Department of Defense announced late Friday an agreement with AstraZeneca for late-stage development and large-scale manufacturing of the company's COVID-19 investigational product AZD7442, a cocktail of two monoclonal antibodies, that may help treat or prevent infection with SARS-CoV-2, the coronavirus that causes COVID-19. "The goal of AstraZeneca's partnership with the U.S. Government is to develop a monoclonal antibody cocktail that can help prevent infection. An effective monoclonal antibody that can prevent COVID-19, particularly one that is long-lasting and delivered by intramuscular injection, may be of particular use in certain groups. This includes people who have compromised immune function, those who are over 80 years old, and people undergoing medical treatments that preclude them from receiving a COVID-19 vaccine. If the FDA authorizes use of AZD7442 for prevention of SARS-CoV-2, as outlined in agency guidance, the federal government will distribute the doses at no cost. As is customary with government-purchased medical products, healthcare professionals could charge for the cost of administering the product," the HHS said. The Biomedical Advanced Research and Development Authority, or BARDA, part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command, to provide approximately $486M to AstraZeneca for two Phase 3 clinical trials and related development activities, including a large-scale manufacturing demonstration project and supply of AZD7442 doses in the United States. Reference Link
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GE | Hot Stocks08:05 EDT General Electric gets FDA clearance for Vivid Ultra Edition - GE Healthcare announced U.S. FDA 510k clearance for its Ultra Edition package on Vivid1 cardiovascular ultrasound systems, which includes new features based on artificial intelligence, AI, that enable clinicians to acquire faster, more repeatable exams consistently. Methodical assessments of heart function are key in echocardiography but can be tedious and time-consuming to acquire. High quality data acquisition and operator skill are key elements to achieve accurate and complete exams. And, as patients undergo subsequent monitoring exams, the reproducibility of exam assessments is key to identifying improvement or disease progression. Vivid Ultra Edition brings increased efficiencies to the scanning process for reduced exam time through up to 80% fewer clicks3, 99% accuracy4 and less inter-operator
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TMO | Hot Stocks08:05 EDT Thermo Fisher introduces two new SARS-CoV-2 antibody tests - Thermo Fisher introduced two new SARS-CoV-2 antibody tests: the Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test, and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test. These new tests for detecting COVID-19 antibodies expand the company's leading response to the pandemic, which ranges from molecular diagnostic tests and sample collection products, to personal protective equipment, to support of therapy and vaccine development and manufacturing. Both of these new antibody tests are designed to meet the need for open ELISA and automated workflows. This flexibility enables laboratories to run the tests at customizable speed and throughput while using automated instruments already in place, minimizing initial costs and reducing the time needed to begin testing. Additionally, these tests are now available in Europe and countries accepting the CE Mark.
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EBAY | Hot Stocks08:03 EDT eBay to authenticate sneakers $100+ in U.S. - eBay announces the expansion of its Authenticity Guarantee service for sneaker sales on the platform. Through this program, all new and pre-owned collectible sneakers sold on eBay for over $100 in the U.S. will be fully vetted and verified by an independent team of industry experts. The service launches this month with the initial authentication of the most popular sneaker styles and brands on the marketplace, and will ramp to include all $100+ sneaker sales by early 2021.
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VLDR BIDU | Hot Stocks08:03 EDT Velodyne Lidar announces three-year sales agreement with Baidu - Velodyne Lidar (VLDR) announced a three-year sales agreement with Baidu (BIDU) for its Alpha Prime lidar sensors. The Alpha Prime sensors will be utilized for autonomous applications. Velodyne's manufacturing delivers attractive pricing for Baidu and its Apollo partners. Velodyne Lidar announced a three-year sales agreement with Baidu for its Alpha Prime lidar sensors. Baidu and Baidu's Apollo program, an open-source autonomous vehicle software platform, selected the Alpha Prime for its range, resolution and field of view that collectively address the requirements for autonomous vehicles. The Alpha Prime sensor produces millions of data points per second, enabling navigation in real time to detect objects, vehicles and people that might pose a collision threat. The Alpha Prime can help autonomous vehicles navigate roadways at various speeds, traveling in a range of road conditions such as rain, sleet and snow. Baidu has been a strategic investor in Velodyne since 2016.
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NVEE | Hot Stocks08:03 EDT NV5 Global awarded $4M USGS lidar survey contract - NV5 Global has been awarded a $4M contract by the United States Geological Survey to conduct a lidar survey across 16,981 miles in the State of Montana to support the 3D Elevation Program. This project was initiated by the Montana State Library and will provide valuable data for flood plain mapping and land management across lands of tribal nations and high hazard dam areas.
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ACA | Hot Stocks08:03 EDT Arcosa acquires Strata Materials for approximately $87M - Arcosa announced that it has acquired Strata Materials for approximately $87M. Strata is a leading provider of recycled aggregates in the Dallas-Ft. Worth area, with 5 recycled aggregates locations and 1 natural aggregates plant. Strata had trailing 12 month Adjusted EBITDA of approximately $10.2M as of August 31, implying an ~8.5x EBITDA multiple. Strata produced more than 2 million tons of aggregates in the last 12 months. Commenting on the transaction, Antonio Carrillo, Arcosa's President and CEO, noted, "Building on the Cherry acquisition we completed in January 2020, we are excited to replicate this model in the Dallas-Ft. Worth region. Strata's strategic network will allow us to serve customers with a complementary product offering that includes both recycled and natural aggregates. We believe that this model will have increasing value as the construction industry seeks to reduce transportation costs and its carbon footprint by using both recycled and natural
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GRWG | Hot Stocks08:02 EDT GrowGeneration acquires Hydroponics Depot, terms not disclosed - GrowGeneration announced its acquisition of Hydroponics Depot, Phoenix's largest indoor and outdoor garden center. With the addition of Hydroponics Depot, GrowGen's portfolio of hydroponic garden centers now includes 29 stores across 11 states.
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IMMU | Hot Stocks08:01 EDT Immunomedics announces orphan drug designation for Trodelvy - Immunomedics announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration has granted Trodelvy orphan status for the treatment of adult and pediatric patients with glioblastoma.
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HUYA | Hot Stocks07:49 EDT HUYA trading resumes
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APDN | Hot Stocks07:37 EDT Applied DNA Sciences subsidiary secures over $1M in COVID-19 testing contracts - Applied DNA Sciences announced that Applied DNA Clinical Laboratories, or ADCL, its wholly-owned subsidiary, has secured COVID-19 surveillance testing contracts under its testing-as-a-service, or TaaS, offering that are estimated to generate more than $1M in total annualized revenue beginning October 1. The company's surveillance testing revenue expectation is contingent on full-term participation by TaaS customers, including: private schools based in Long-Island, N.Y., including Harbor Country Day School. Education customers comprise the bulk of the company's current testing volume; several New York State-based small enterprises and private clients. Unlike diagnostic testing, which looks for the occurrence of COVID-19 at the individual level, surveillance testing looks for infection within a defined population or community and can be used for making health management decisions at the population level. Surveillance testing does not require a prescription. In surveillance testing, pooled test results are returned to the sponsoring organization in the aggregate, not directly to the individual, and may be performed without CLIA certification. Concurrently, the company is executing on a sales and marketing strategy to build a pipeline of Linea COVID-19 Diagnostic Assay Kit and TaaS opportunities through: Outreach to independent and hospital laboratories in COVID-19 hotspots nationally and regionally to offer an additional diagnostic kit supply line; Outreach to local laboratories to construct a reference laboratory relationship for overflow testing; Deployment of testing at Stony Brook University in accordance with a recently signed Master Services Agreement. Separately, the company announced that the State of New York Department of Health, or DoH, completed the initial inspection of ADCL on October 7. Inspection reports are generally filed by the DoH within 4 to 6 weeks of the inspection date. A passing grade would confer onto ADCL DoH's Clinical Laboratory Program certification under which ADCL can function as a certified clinical lab. CLEP-approved clinical laboratories located in New York State meet Clinical Laboratory Improvement Amendments of 1988 proficiency testing and accreditation requirements that would enable ADCL to receive patient samples collected nationally for testing. A failing grade would require ADCL to remediate deficiencies prior to any re-inspection request. The company offers no timetable for receipt of CLEP-CLIA certifications at this time.
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DOYU... | Hot Stocks07:36 EDT DouYu, Huya enter stock-for-stock merger agreement - Huya (HUYA) and DouYu International Holdings (DOYU) announced that they have entered into an Agreement and Plan of Merger, dated October 12, with Tiger Company Ltd., a newly formed company with limited liability incorporated under the laws of the Cayman Islands and a direct wholly owned subsidiary of Huya, and, solely for the limited purposes set forth therein, Nectarine Investment Limited, a wholly owned subsidiary of Tencent Holdings (TCEHY). Pursuant to the Merger Agreement, Huya will acquire all the outstanding shares of DouYu, including ordinary shares represented by American depositary shares, through a stock-for-stock merger. Pursuant to the Merger Agreement, at the effective time of the Merger, each ordinary share of DouYu issued and outstanding immediately prior to the Effective Time (other than the DouYu Shares represented by American depositary shares, each representing 1/10 of a DouYu Share (the "DouYu ADSs"), the Excluded Shares and any Purported Dissenters Shares, each as defined in the Merger Agreement) will be cancelled in exchange for the right to receive 7.30 validly issued, fully paid, non-assessable Class A ordinary shares of Huya, and each DouYu ADS issued and outstanding immediately prior to the Effective Time will be cancelled in exchange for the right, at the direction of DouYu's depositary bank, to receive 0.730 American depositary shares of Huya, each representing one Huya Class A Share. If the Merger is completed, the shareholders of Huya and DouYu immediately prior to the Merger, respectively, will each hold approximately 50% shares of the combined company on a fully diluted basis. Concurrently with the execution of the Merger Agreement, DouYu and Tencent entered into a Reassignment Agreement, dated October 12, 2020, pursuant to which Tencent will assign its interests in the game live streaming business operated by the Tencent group under the "Penguin e-Sports" brand to DouYu and deepen its business cooperation with DouYu in order to integrate the Penguin Business with the business of the combined Huya and DouYu upon the Merger, for a total consideration of $500M. The closing of the Reassignment is conditioned on, and is expected to occur substantially concurrently with, the closing of the Merger. The closing of the Merger is also conditioned on, and is expected to occur substantially concurrently with, the closing of the Reassignment. The Merger, which is currently expected to close during the first half of 2021, is subject to customary closing conditions including the approval of the Merger Agreement and the Merger by an affirmative vote of holders of the DouYu Shares representing at least two-thirds of the voting power of the DouYu Shares present and voting in person or by proxy as a single class at a meeting of DouYu's shareholders which will be convened to consider the approval of the Merger Agreement and the Merger. Tencent and Messrs. Shaojie Chen and Wenming Zhang, the Chief Executive Officer and co-Chief Executive Officer of DouYu, have agreed to vote all of the DouYu Shares and DouYu ADSs they beneficially own, which collectively represent approximately 54.6 % of the voting rights attached to the total outstanding DouYu Shares as of the date of the Merger Agreement, in favor of the authorization and approval of the Merger Agreement and the Merger.
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TWLO | Hot Stocks07:34 EDT Twilio to acquire customer data platform Segment for approximately $3.2B - Twilio (NYSE: TWLO) announced that it has entered into a definitive agreement to acquire Segment for approximately $3.2B in Twilio Class A common stock, on a fully diluted and cash free, debt free basis. The transaction is expected to close in the fourth quarter of 2020. "Data silos destroy great customer experiences," said Jeff Lawson, co-founder and CEO of Twilio. "Segment lets developers and companies break down those silos and build a complete picture of their customer. Combined with Twilio's Customer Engagement Platform, we can create more personalized, timely and impactful engagement across customer service, marketing, analytics, product and sales. We are thrilled to welcome Segment to the Twilio team." The transaction will accelerate Twilio's growth with a combined total addressable market of $79 billion, bringing Twilio one step closer to achieving the company's vision of becoming the world's leading customer engagement platform trusted by developers and companies globally. Twilio will acquire Segment for approximately $3.2B in Twilio Class A stock, and Segment will become a division of Twilio. The boards of directors of Twilio and Segment have each approved the transaction The transaction is expected to close during the fourth quarter of Twilio's fiscal 2020, ending December 31.
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EVBG SONO | Hot Stocks07:33 EDT Everbridge appoints John Maeda as chief customer experience officer - Everbridge (EVBG) announced the appointment of John Maeda to the new role of chief customer experience officer. Prior to Everbridge, Maeda served as chief experience officer at Publicis where he led their CX/DX practices. Maeda serves on the boards of Sonos (SONO) and the Cooper Hewitt Smithsonian Design Museum.
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REKR | Hot Stocks07:33 EDT Rekor Systems announces Rekor One roadway intelligence platform - Rekor Systems announced Rekor One, a new platform that will serve as a unifying source of roadway intelligence for government agencies across cities, counties and states. The platform will support multiple community safety, intelligent roadway and revenue generation activities. Rekor One will provide government agencies with a comprehensive vehicle intelligence system that supports multiple agency-specific missions. With Rekor One, governments will be able to leverage their existing IP cameras and transform them into a safe and smart multi-dimensional intelligent roadway network. By interfacing with multiple databases and operating systems, Rekor One will allow governmental units to observe security and privacy protocols and fractionalize costs based on relative end user value. Each participating agency receives a unique user interface and dashboard, which draws on Rekor One's unified vehicle recognition intelligence to provide data customized to the agency's specific needs. This will eliminate redundant systems and single function applications to help use public funds wisely.
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DOYU... | Hot Stocks07:32 EDT DouYu, Huya enter merger agreement -
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RVMD | Hot Stocks07:32 EDT Revolution Medicines to present interim fata from Phase 1b/2 trial of RMC-4630 - Revolution Medicines announced that interim data from the company's ongoing Phase 1b/2 clinical trial evaluating the combination of RMC-4630 and cobimetinib will be reported in an oral presentation in a plenary session at the upcoming EORTC-NCI-AACR 32nd Symposium on Molecular Targets and Cancer Therapeutics being held virtually October 24-25, 2020. The ongoing Phase 1b/2 RMC-4630-02 trial is an open-label, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic proles of RMC-4630 and cobimetinib in adult patients with relapsed/refractory solid tumors that harbor specific genomic mutations. The study tested several dosing regimens, including intermittent RMC-4630 plus daily or intermittent cobimetinib. Preliminary data to be presented at ENA 2020 will focus on safety, tolerability and pharmacokinetic findings from combination dosing regimens. Details of the upcoming oral presentation at ENA 2020 are as follows: Title: Intermittent dosing of RMC-4630, a potent, selective inhibitor of SHP2, combined with the MEK inhibitor cobimetinib, in a Phase 1b/2 clinical trial for advanced solid tumors with activating mutations of RAS signaling Session: Plenary Session 1: Late-Breaking and Best Proffered Papers Presenting Author: Johanna C. Bendell, M.D., Sarah Cannon Research Institute, Nashville, Tennessee Presentation Date/Time: Saturday, October 24, 2020, 3:45 - 3:55 p.m. RMC-4630 and cobimetinib are targeted inhibitors of oncogenic proteins at distinct positions within the RAS signaling cascade that is frequently exploited by human cancers and may develop adaptive resistance to single agent treatment. RMC-4630 is a potent and orally bioavailable small molecule designed to selectively inhibit the activity of SHP2, an upstream cellular protein that plays a key role in modulating cell growth by transmitting signals from receptor tyrosine kinases to RAS. Cobimetinib, marketed in the U.S. by Genentech, a member of the Roche group, inhibits the activity of MEK, a downstream effector of RAS that affects cell survival and growth. Cobimetinib is approved in the U.S. for the treatment of patients with BRAFV600E or BRAFV600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib.
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PSN | Hot Stocks07:20 EDT Parsons awarded SharkSeer 2.0 task order worth up to $28M - Parsons was awarded the SharkSeer 2.0 task order under the Defense Information Systems Agency's Systems Engineering, Technology, and Innovation contract. The firm-fixed price contract includes one base year and four option years, which, if exercised, will provide for a total potential value of $28M. SharkSeer 2.0 is a new requirement for DISA and will enhance the program's original operational capability with revamped architecture and new task requirements. The effort supports an enterprise boundary defense system that uses artificial intelligence to identify and mitigate zero-day cyber attacks and advanced persistent threats to protect the Department of Defense networks.
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TSC | Hot Stocks07:17 EDT TriState Capital in pact for $105M in new capital to fund 'high-growth' - TriState Capital Holdings has entered into a definitive agreement with funds managed by Stone Point to raise $105M in new capital to fund the continued execution of the company's high-growth strategy for its TriState Capital Bank and Chartwell Investment Partners businesses. TriState Capital expects to issue common equity, preferred stock and warrants to Stone Point-managed funds upon closing of the transaction, which is expected during the fourth quarter of 2020, subject to approval by the Pennsylvania Department of Banking and Securities, the parties entering into a registration rights agreement to provide customary registration rights and satisfaction of other customary closing conditions. "We are well positioned with growth capital through 2021 and have never been more excited about the opportunities we're positioned to take advantage of than we are at this moment," TriState Capital Chairman and Chief Executive Officer James F. Getz said. "Stone Point shares our confidence in TriState Capital's ability to excel in the current economic environment by remaining squarely focused on providing exceptional service to our sophisticated clients and to financial intermediaries."
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DSPG | Hot Stocks07:16 EDT DSP Group ships 100 millionth SmartVoice SoC - DSP Group announced it has shipped its 100 millionth SmartVoice system-on-chip, marking a major milestone. This milestone is testimony to the importance DSP Group's global customers, including Google, Amazon, Facebook, GoPro, Logitech, Samsung, Lenovo, and Leviton all place on performance, cost-effectiveness, low power, and reliability when it comes to ensuring a satisfying and enjoyable end-user VUI experience.
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BYSI... | Hot Stocks07:15 EDT BeyondSpring announces formation of Partnership Advisory Committee - BeyondSpring (BYSI) announced that it has formed a Partnership Advisory Committee comprised of former pharmaceutical veterans and industry leaders. The committee is tasked with supporting BeyondSpring's business development activities related to its lead asset, Plinabulin, and other pipeline assets. Mukul Agarwal, former Vice President, Corporate Development, at Forty Seven (FTSV) and Dr. Daniel Zabrowski, former Global Head of Pharma Partnering at Roche (RHHBY) and current BeyondSpring Board member, have been appointed as initial members of the committee. The Company expects to name additional members over time. Agarwal currently serves as ReCode Therapeutics' Chief Business Officer. Zabrowski currently serves as a Venture Partner at Decheng Capital.
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GNLN | Hot Stocks07:12 EDT Greenlane announces global distribution expansion of Marley Natural accessories - Greenlane Holdings announced that it will be distributing Marley Natural accessories worldwide. The exclusive deal brings the brand to specialty locations in Central and South America, the Caribbean, and Europe. Marley Natural accessories pay homage to the legacy of Bob Marley, the musical pioneer and activist who is synonymous with cannabis culture.
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VEEV RHHBY | Hot Stocks07:11 EDT Roche selects Veeva Systems for cloud applications - Veeva Systems (VEEV) announced that Roche (RHHBY) has selected Veeva Development Cloud applications globally to streamline Veeva Systems The company is switching to unified applications in Vault Clinical, Vault RIM, and Vault Quality suites to increase efficiency, enhance data quality, and drive compliance throughout the product lifecycle. "Speeding drug development and product supply are strategic priorities for innovative life sciences companies like Roche," said Rik Van Mol, vice president of Veeva Development Cloud. "Veeva Development Cloud breaks down system and process silos so life sciences companies can more quickly bring innovative treatments to patients."
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VBLT | Hot Stocks07:11 EDT VBL Therapeutics announces European patent for Anti-MOSPD2 antibodies - VBL Therapeutics announced that the European Patent Office has granted Patent #3328408, which covers VBL's proprietary investigational anti-MOSPD2 monoclonal antibodies to treat inflammatory conditions. VBL is currently advancing its lead anti-MOSPD2 candidate through IND-enabling studies. VBL has recently demonstrated ex-vivo activity of anti-MOSPD2 antibodies in patients with relapsing-remitting and progressive multiple sclerosis, as well as in animal models of rheumatoid arthritis, nonalcoholic steatohepatitis and inflammatory bowel disease. The claims in the granted patent cover the use of such an antibody/antibody fragment to treat a wide range of inflammatory and autoimmune conditions. The patent is expected to provide protection for VBL's MOSPD2 antibodies for inflammation, until at least July 2036. The Company recently held a pre-IND meeting with the FDA and has reached alignment with the Agency on the path forward for its lead anti-MOSPD2 candidate. A first-in-human study is planned to commence in the second half of 2021.
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ICE | Hot Stocks07:10 EDT IntercontinentalExchange provides update on launch of ICE Futures Abu Dhabi - Intercontinental Exchange provides an update on its plans to launch ICE Futures Abu Dhabi and the world's first futures contracts based on Murban crude oil. Subject to the completion of regulatory approvals, ICE plans to launch IFAD and trading in Murban futures contracts late in the first quarter of 2021. A more specific date for the launch of trading will be announced in due course. In November 2019, ICE announced its plans to launch IFAD, with the Abu Dhabi National Oil Company and nine of the world's largest energy traders partnering with ICE on the launch. ICE Murban Futures will be a physically delivered contract with delivery at Fujairah in the United Arab Emirates on a free on board basis. ICE Murban Futures will be complemented with a range of cash settled derivatives which IFAD plan to launch for day one of trading.
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CERC | Hot Stocks07:09 EDT Cerecor appoints Gilla Kaplan to board of directors - Cerecor announced the appointment of Gilla Kaplan, Ph.D., to the Board of Directors. She was the Director of the Global Health Program, Tuberculosis, at the Bill and Melinda Gates Foundation from January 2014 until April 2018.
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LIVX | Hot Stocks07:08 EDT LiveXLive Media exceeds $2M in total pay-per-view sales since May launch - LiveXLive Media announced that it has generated over $2M in total sales from Pay-Per-View livestream concerts and vodcast/podcasts including ticket sales, merchandise, advertising and sponsorships since launch in May 2020. Over 8% of all PPV ticket buyers also became LiveXLive Annual Plus subscribers.
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HUYA | Hot Stocks07:08 EDT HUYA trading halted, news pending
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KYMR | Hot Stocks07:08 EDT Kymera Therapeutics to present at Annual Targeted Protein Degradation Summit - Kymera Therapeutics will share two key presentations at the 3rd Annual Targeted Protein Degradation Summit on Oct. 14 and 15. Kymera Co-Founder, President and CEO, Nello Mainolfi, PhD, will deliver a keynote presentation, "Targeted Protein Degradation Beyond Oncology," and share recent data related to the company's IRAK4 program including findings from the company's non-interventional trial in hidradenitis suppurativa patients. Haojing Rong, PhD, Vice President of Pre-Clinical Development, will present on Kymera's efforts to elucidate preclinical pharmacokinetic/pharmacodynamic relationships to predict clinical PK/PD. "Targeted Protein Degradation: Beyond Oncology" will be presented by Dr. Mainolfi, PhD, Co-Founder, President and Chief Executive Officer of Kymera on Oct. 15 at 9:00 AM ET. Dr. Mainolfi will present on the company's Pegasus platform and approach to target selection, focusing on the IRAK4 degrader program in immunology/inflammation, and will present interim findings from a non-interventional trial evaluating IRAK4 expression and the activity of Kymera's lead IRAK4 protein degrader KT-474 in hidradenitis suppurativa and atopic dermatitis. Data were first shared during a poster presentation at the 5th Annual Symposium on Hidradenitis Suppurativa Advances on October 9th, 2020. Key findings presented demonstrated that IRAK4 levels were higher in diseased compared to unaffected skin, further supporting the relevance of the IRAK4 signaling pathway in HS. The study also showed that ex vivo incubation of HS blood with Kymera's protein degrader KT-474 reduced IRAK4 to a level approaching the lower limits of detection across all PBMC subsets. "PK/PD Relationship in Targeted Protein Degradation" will be presented by Dr. Rong, PhD, Vice President of Pre-Clinical Development on Oct. 14 at 4:00 PM ET. Kymera's second presentation will center on the critical need to understand key principles of PK/PD relationships in preclinical species for this new modality and use these learnings to establish optimal dosing paradigms and schedules in preclinical species and eventually to predict human PK/PD and active doses as accurately as possible.
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VRTS | Hot Stocks07:07 EDT Virtus Investment reports preliminary total AUM $116.5B as of September 30 - Virtus Investment Partners reported preliminary long-term and total assets under management as of September 30, of $115B and $116.5B, respectively. The increase in long-term AUM from June 30 reflected market appreciation and positive net flows, including net inflows in retail separate accounts, mutual funds, and exchange traded funds, partially offset by net outflows in other products.
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CUB | Hot Stocks07:06 EDT Cubic announces CMPS unit awarded a $7.5M contract by U.S. Army - Cubic announced its Cubic Mission and Performance Solutions, CMPS, business division was awarded a contract worth $7.5M to develop and flight test prototype software-defined radios (SDR) for the U.S. Army. The contract is part of an effort to develop a next-generation datalink waveform for unmanned aircraft systems, UAS, and manned-unmanned teaming, MUM-T. The SDRs will feature an emerging communications waveform, designed to operate in contested environments. Cubic's advanced solution will be offered in a package with optimized size, weight, power and cooling for hosting on several host platforms including the U.S. Army's small unmanned aerial system platforms. Successful flight tests at the end of the one-year program are expected to inform future waveform specifications and future related acquisitions.
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ALT | Hot Stocks07:06 EDT Altimmune, UAB announces publication of preclinical data for AdCOVID - Altimmune pre-published a comprehensive preclinical evaluation of its single-dose, intranasal COVID-19 vaccine candidate, AdCOVID, in a manuscript entitled, "Single-dose intranasal administration of AdCOVID elicits systemic and mucosal immunity against SARS-CoV-2 in mice." The studies were conducted as part of Altimmune's ongoing collaboration with the University of Alabama at Birmingham and expand upon earlier preclinical data presented for the AdCOVID program. AdCOVID is based on the Company's adenovirus-based intranasal vaccine platform and expresses the receptor binding domain of the SARS-CoV-2 spike protein. The RBD is essential for viral infection and the majority of neutralizing antibodies from people that have recovered from COVID-19 bind to the RBD, highlighting the importance of the RBD in controlling infection. AdCOVID is designed to offer significant advantages over other COVID-19 vaccine approaches, including intranasal administration, single-dose effectiveness, broad activation of the immune response, and the ability to ship and store the vaccine conveniently and inexpensively. Altimmune anticipates filing an IND with the U.S. Food and Drug Administration and commencing a Phase 1 safety and immunogenicity trial of AdCOVID in the fourth quarter of 2020. Key Findings of the Study: In the BioRxiv.org publication, the authors present data demonstrating strong activation of all three arms of the adaptive immune system following a single intranasal dose of AdCOVID. These data, conducted in two strains of mice, show that AdCOVID stimulated strong immune responses including: Serum Neutralizing Immunity: AdCOVID elicited a median serum neutralization titer against wild-type SARS-CoV-2 virus of up to 1:563 one-month post-vaccination in a 50% focus reduction neutralization test. For context, this level of neutralizing activity was at least 3-fold higher than the minimum titer recommended by the FDA for convalescent plasma used in the treatment of COVID-19. T cell Immunity: AdCOVID stimulated both CD4+ and CD8+ antigen-specific T cell responses following a single intranasal vaccination. The response was focused in the lungs of the vaccinated mice and was biased toward CD8+ T cells. A significant fraction of the CD8+ T cells in the lung were found to be non-circulating tissue-resident memory T cells, which have been shown to play a front-line role in fighting respiratory viral infections. Mucosal Immunity: Nasal mucosal immunity is a local type of immunity that has the potential to stop both infection and transmission of the virus. Significantly, only an intranasal vaccine can activate this important type of immunity. AdCOVID induced a 29-fold increase in mucosal IgA specific to the RBD, well above the level associated with protection in clinical studies of mucosal influenza vaccines where a 2 to 4-fold increase in IgA was found to be correlated with protection. The observed IgA response, together with the lung-associated Trm T cell response noted above, provided an additional level of immune response that may provide enhanced protection against COVID-19 disease and transmission.
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GAN | Hot Stocks07:06 EDT Gan Limited launches new simulated internet sports betting - Gan Limited announced the launch of a simulated internet sports betting experience for an existing major midwestern region retail casino operator client and available at www.PlayJACK.com. Available online, simulated sports betting represents a material extension of GAN's current simulated gaming product and leverages the existing technical integration between Gan's GameSTACK enterprise software platform, alongside sports betting technology partner Kambi. Sports gamblers can sign up online, commence sports betting purely for entertainment purposes, and see how they perform relative to other sports gamblers in their state. All major U.S. sports events are available together with a full range of pre-game and in-running betting, powered by Kambi. GAN's retail casino operator clients of simulated gaming can now seek to gain an advantage previously only enjoyed by major daily fantasy sports operators by acquiring future sports gamblers online, at a lower marketing cost than the expected cost tomorrow, once the real money regulated sports betting market commences. The company said Gan clients can now appeal to and engage online with the young-to-middle-aged male sports gambler who sits at the center of the Internet sports gambling consumer demographic and future Internet sports betting revenue opportunity. Management anticipates the addition of simulated sports betting to accelerate sales of simulated gaming to additional U.S. retail casino operators. Gan's integrated solutions offer both simulated internet casino gaming to our partners' existing retail customers, as well as simulated sports betting.
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BHC EYEN | Hot Stocks07:06 EDT Bausch Health licenses Eyenovia's investigational atropine ophthalmic solution - Bausch Health, Bausch + Lomb, and Eyenovia (EYEN), announced that an affiliate of Bausch Health has acquired an exclusive license in the United States and Canada for the development and commercialization of an investigational microdose formulation of atropine ophthalmic solution, which is being investigated for the reduction of pediatric myopia progression, also known as nearsightedness, in children ages 3-12. This investigational formulation of atropine is delivered with Eyenovia's proprietary Optejet dispenser technology.
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FOLD | Hot Stocks07:04 EDT Amicus announces additional interim clinical data for AT-GTX-501 - Amicus Therapeutics announced additional positive interim results from its CLN6 Batten disease gene therapy program, AT-GTX-501. The results are featured in a virtual poster presentation at the Joint 16th International Child Neurology Congress and 49th Annual Child Neurology Society Meeting being held October 12-23, 2020. The Abigail Wexner Research Institute at Nationwide Children's Hospital is conducting the ongoing Phase 1/2 clinical study of a single one-time intrathecal administration of AT-GTX-501 gene therapy for variant late-infantile neuronal ceroid lipofuscinosis 6 disease, also known as CLN6 Batten disease. With no approved treatments, CLN6 Batten disease is a fatal neurologic disease that rapidly robs children of their ability to walk, speak, think, and see. Clinical Data Highlights: Interim safety data are available for 13 children with CLN6 Batten disease. Interim efficacy data are available for the first 12 children reaching the 12-month timepoint and for eight children up to 24 months, post-administration of the AAV-CLN6 gene therapy. Safety: Treatment with AT-GTX-501 was generally well tolerated. The majority of adverse events were mild and unrelated to treatment. No pattern of adverse events related to AAV or CLN6 immunogenicity was observed. Additional details are provided in the presentation. Hamburg Motor & Language Aggregate Score: The Hamburg Motor & Language Score, an assessment of ambulation and speech, shows a meaningful effect in slowing disease progression at 12 and 24 months: On a combined scale of 0 to 6, the mean rate of decline was 0.4 vs 1.2 points over 12 months in treated patients vs subjects from the natural history cohort. On a combined scale of 0 to 6, the mean rate of decline was 0.6 vs 2.4 points over 24 months in treated patients vs subjects from the natural history cohort. Natural History: Within the natural history cohort, two years from their first decline on the Hamburg Motor & Language Score 63% of subjects experienced an additional 2-point decline, compared to only 13% of treated patients. Regulatory interactions for AT-GTX-501 are ongoing and the Company expects to provide feedback on the path forward in 2021. Amicus has exclusive rights to the CLN6 gene therapy program developed at the Abigail Wexner Research Institute at Nationwide Children's Hospital.
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KEN | Hot Stocks07:03 EDT Kenon's OPC to acquire CPV power business in U.S. for $630M in cash - Kenon Holdings' subsidiary OPC Energy announced the execution of an agreement by CPV Group, an entity in which OPC holds a 70% stake, for the acquisition of Competitive Power Ventures group from Global Infrastructure Management. CPV is engaged in the development, construction and management of renewable energy and conventional energy (natural gas-fired) power plants in the United States. Consideration for the acquisition is $630M (payable in cash), subject to post-closing adjustments based on closing date cash, working capital and debt. Additionally, an amount in the range of $54M-$95M is payable by the Buyer in respect of CPV's equity in the Three Rivers project, which is currently under construction, which may be paid at the Buyer's option in cash or a vendor loan at terms that have been agreed between the parties. The acquisition of CPV will be conducted through the acquisition by CPV Group LP of 100% of the equity interests of three companies, which hold CPV's interests in companies with plants in operation as well as development projects and CPV's management company. The acquisition agreement includes representations and warranties and covenants by the parties, including covenants regulating the conduct of the CPV business between signing and closing. The Seller's representations will generally expire at closing, other than certain fundamental representations which will survive for two years. The Buyer has obtained a representation and warranty insurance policy in connection with the acquisition agreement with international insurers with a liability cap of up to $52M for a period ranging from three to six years, depending on the particular representation and warranty.
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ALRN | Hot Stocks07:02 EDT Aileron Therapeutics to present PoC data for ALRN-6924 at ENA 2020 - Aileron Therapeutics announced that proof-of-concept data from the company's Phase 1b study of ALRN-6924 will be featured in a late-breaking poster presentation during the 32nd EORTC-NCI-AACR Annual Symposium on Molecular Targets and Cancer Therapeutics, being held virtually October 24 - 25, 2020. The abstract entitled, "Prevention of Chemotherapy-induced Myelosuppression in SCLC patients treated with the Dual MDM2/MDMX inhibitor ALRN-6924," will be presented starting Saturday, October 24, on the ENA 2020 website. The data to be presented is from Aileron's Phase 1b study, which is evaluating ALRN-6924 as a therapeutic agent administered ahead of chemotherapy to prevent chemotherapy-induced toxicities, such as severe anemia, neutropenia and thrombocytopenia, in patients with p53-mutated small cell lung cancer who are being treated with the chemotherapy topotecan. In June 2020, Aileron announced positive interim data from this study. Aileron's long-term vision is to bring chemoprotection to all patients with p53-mutated cancers, which represent at least 50% of cancer patients, regardless of cancer type or chemotherapy.
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MESA | Hot Stocks07:01 EDT Mesa Air reports 21,780 block hours in September - Mesa Air Group reported Mesa Airlines' operating performance for September 2020. Mesa Airlines reported 21,780 block hours in September 2020, a 40.3 percent drop from September 2019 as a result of reduced schedules during the COVID-19 pandemic. The company also reported a controllable completion factor of 99.87 percent and 99.95 percent for its American and United operations, respectively.
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CEIX CCR | Hot Stocks06:56 EDT Consol Energy, Consol Coal generate income on asset sales - Consol Energy (CEIX) and Consol Coal (CCR) provided an update on several transactions that were executed during the last several months. Since July 1, Consol has taken steps to bolster its financial flexibility and liquidity that included sales of land and mineral assets, gas wells and coal reserves outside of its active operations. In aggregate, CEIX and CCR expect to generate miscellaneous income and gains on sale of assets in the second half of 2020 totaling $60M-$70M and $9M-$10M, respectively, related to these transactions. Consol believes these transactions enable it to enhance liquidity and bolster financial flexibility. The company said these transactions also allow CEIX to accelerate its strategy of de-leveraging its balance sheet through open market repurchases, and they position the company well to take advantage of a potential coal market recovery.
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ALPMY SGEN | Hot Stocks06:53 EDT Astellas Pharma, Seagen announce results from second cohort of EV-201 trial - Astellas Pharma (ALPMY) and Seagen (SGEN) announced topline results from the second cohort of patients in the pivotal phase 2 single-arm clinical trial known as EV-201. The cohort is evaluating the antibody-drug conjugate Padcev for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and have not received a platinum-containing chemotherapy and are ineligible for cisplatin. Results showed a 52% objective response rate, or ORR, per blinded independent central review and a median duration of response of 10.9 months. The most frequently reported treatment-related adverse events Grade 3 or greater that occurred in more than 5% of patients were: neutropenia, rash, fatigue, increased lipase, diarrhea, decreased appetite, anemia and hyperglycemia. Data from cohort 2 of the trial will be submitted for presentation at an upcoming scientific congress and will be discussed with regulatory authorities. Padcev is a first-in-class antibody-drug conjugate, or ADC, that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. The FDA granted accelerated approval to Padcev in 2019 based on results from the first cohort in this trial, which included patients whose disease had progressed during or following platinum-based chemotherapy and a PD-1/L1 inhibitor.
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NBY | Hot Stocks06:51 EDT NovaBay regains compliance with NYSE American listing standards - NovaBay Pharmaceuticals announces it believes that it has regained full compliance with the NYSE American's continued listing standards, subject to NYSE American's formal confirmation that the company has regained compliance after the company files its Quarterly Report on Form 10-Q for the quarter ended September 30.
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LAZ | Hot Stocks06:50 EDT Lazard reports preliminary AUM approximately $227.8B as of September 30 - The month's AUM included market depreciation of $3.2B, foreign exchange depreciation of $2B and net inflows of $0.7B. Preliminary average assets under management for the quarter ended September 30 were $226B.
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LLY | Hot Stocks06:49 EDT Eli Lilly announces new efficacy, safety data from SERENITY trial - Eli Lilly announced new efficacy and safety data from the Phase 2 SERENITY study evaluating mirikizumab in patients with moderately to severely active Crohn's disease, a form of inflammatory bowel disease, or IBD, that can cause systemic inflammation manifested as abdominal pain, diarrhea, fever, weight loss and lead to intestinal obstruction, fibrosis and other complications. SERENITY included a 12-week induction period and 40-week continued treatment period, which evaluated the safety and efficacy of multiple dosing regimens and two methods of administration through Week 52 as measured by endoscopic response, which reflects substantial reduction in inflammation of the lining of the bowel as seen during an endoscopy, and by Patient Reported Outcomes, or PRO, remission, two important treatment goals in Crohn's disease. Detailed results from the trial are being presented virtually in an abstract session at the United European Gastroenterology Week, or UEG Week. In the induction period, patients were randomized across four treatment arms to receive placebo or one of three doses of mirikizumab intravenously. At 12 weeks, patients who showed endoscopic improvement were randomized to continue mirikizumab treatment, administered either intravenously or subcutaneously. Patients who did not show endoscopic improvement or who had been randomized to the placebo arm in induction were assigned to receive mirikizumab treatment intravenously. In the continued treatment period of the study, patients achieved key secondary outcomes at Week 52 including endoscopic response, PRO remission and endoscopic remission. Nearly 60% of patients achieved endoscopic response. More than 45% of patients achieved PRO remission. Among the subset of patients who achieved endoscopic response at Week 12, 69.6% and 66.7% in the IV and SC groups, respectively, also had endoscopic response at Week 52. Additionally, among those with endoscopic remission at Week 12, 50.0% and 64.3% in the IV and SC groups, respectively, also had endoscopic remission at Week 52. One patient in each group among those who showed endoscopic improvement at Week 12 discontinued due to an adverse event, or AE. Similar frequencies of treatment-emergent AEs and serious AEs were reported in IV and SC groups. The most common treatment-emergent AEs reported were nasopharyngitis, headache and arthralgia. At UEG Week, Lilly also virtually presented additional results for mirikizumab from the Phase 2 Crohn's disease study as well as data on bowel urgency and quality of life in patients with ulcerative colitis, or UC.
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WDR | Hot Stocks06:49 EDT Waddell & Reed reports preliminary AUM $67.9B as of September 30 - Compared to $70.3B on August 31.
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BRO | Hot Stocks06:48 EDT Brown & Brown acquires substantially all assets of Bright & Associates - J. Scott Penny, Chief Acquisitions Officer of Brown & Brown, and James Bright, the principal owner of Bright & Associates and its affiliate Auto Care Essentials, announced that Brown & Brown Dealer Services has acquired substantially all of the assets of Bright & Associates. Bright & Associates is an independent sales and service organization providing F&I products and sales support to the automotive, marine, power sport, and RV markets since 1977.
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SGEN ALPMY | Hot Stocks06:47 EDT Seagen, Astellas announce positive topline results from Phase 2 EV-201 trial - Seagen (SGEN) and Astellas Pharma (ALPMY) announced positive topline results from the second cohort of patients in the pivotal phase 2 single-arm clinical trial known as EV-201. The cohort is evaluating the antibody-drug conjugate PADCEV for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and have not received a platinum-containing chemotherapy and are ineligible for cisplatin. Results showed a 52% objective response rate per blinded independent central review and a median duration of response of 10.9 months. The most frequently reported treatment-related adverse events Grade 3 or greater that occurred in more than 5% of patients were: neutropenia, rash, fatigue, increased lipase, diarrhea, decreased appetite, anemia and hyperglycemia. Data from cohort 2 of the trial will be submitted for presentation at an upcoming scientific congress and will be discussed with regulatory authorities.
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ATV | Hot Stocks06:37 EDT Acorn International enters merger agreement for going private transaction - Acorn International announced that it has entered into a definitive agreement and plan of merger with First Ostia Port, a Cayman Islands exempted company and its wholly owned subsidiary Second Actium Coin, a Cayman Islands exempted company, pursuant to which, the merger sub will merge with and into the company thereby becoming a wholly-owned subsidiary of the controlling shareholder. The company will be acquired in an all-cash transaction by the controlling shareholder. Pursuant to the terms of the merger agreement, each ordinary share, par value 1c per share, of the company, including shares represented by American Depositary Shares, each representing twenty shares, issued and outstanding immediately prior to the effective time, other than the excluded shares shall be cancelled in exchange for the right to receive $1.05 in cash per share without interest. As each ADS represents twenty shares, each ADS issued and outstanding immediately prior to the effective time, other than ADSs representing excluded shares, shall represent the right to receive $21.00 in cash without interest pursuant to the terms and conditions set forth in the merger agreement. The per share merger consideration represents a premium of 44.1% over the company's closing price of $14.57 per ADS as quoted on the New York Stock Exchange, or NYSE, on August 17, the last trading day prior to the day when the company received a non-binding "going private" proposal from the controlling shareholder. The merger consideration also represents an increase of approximately 38.0% over the $15.22 per ADS offered by the controlling shareholder in its revised going-private proposal on August 18 and a premium of approximately 39.4% over the company's closing price of $15.07 per ADS on October 9, the last trading day prior to issuance of this press release. The controlling shareholder intends to fund a substantial portion of the consideration for the merger in the form of debt funding from a third-party lender and has delivered to the company duly executed copies of the loan and security agreement. The board, acting upon the unanimous recommendation of a committee of independent directors established by the board, approved the merger agreement and the merger. The special committee negotiated the terms of the merger agreement with the assistance of its independent financial and legal advisors. The merger, which is currently expected to close during the last quarter of 2020, is subject to customary closing conditions, including the approval of the merger agreement by a requisite company vote of shares representing at least two-thirds of the voting power of the shares present and voting in person or by proxy at a meeting of the company's shareholders which will be convened to consider the approval of the merger agreement and the merger. The company will call a shareholders meeting for the purpose of voting on the adoption of the merger agreement and the transactions contemplated by the merger agreement as soon as practicable. If the merger is completed, the company will continue its operations as a privately held company and will be wholly owned by the controlling shareholder and, as a result of the merger, the company will no longer be listed on the NYSE.
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DPW | Hot Stocks06:33 EDT DPW Holdings announces acceptance plan by NYSE American - DPW Holdings announced that on October 8, the NYSE American notified the company that it has been granted a listing extension until January 24, 2022 on the basis of the plan recently submitted by the company to regain compliance with the NYSE American Company Guide. Specifically, the company has demonstrated how it intends to regain compliance with Sections 1003(a)(ii) and (iii) of the Listing Standards by having stockholders' equity be $6M or more. The company will be subject to periodic review by NYSE during the extension period. Failure to make progress consistent with the plan or to regain compliance with the continued Listing Standards by the end of the extension period could result in the company being delisted from the NYSE.
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ATXI | Hot Stocks06:32 EDT Avenue Therapeutics receives CRL from FDA for IV tramadol - Avenue Therapeutics announced it has received a Complete Response Letter from the U.S. FDA regarding the company's New Drug Application for IV tramadol. The CRL stated that although the pivotal Phase 3 clinical trials demonstrated statistically significant outcomes for all of the primary and many secondary endpoints, the FDA has determined that it cannot approve the application in its present form. The CRL stated that IV tramadol, intended to treat patients in acute pain who require an opioid, is not safe for the intended patient population. Specifically, if a patient requires an analgesic between the first dose of IV tramadol and the onset of analgesia, a rescue analgesic would be needed. The likely choice would be another opioid, which would result in opioid "stacking" and increase the likelihood of opioid-related adverse effects. Other than this potential safety concern, the FDA did not identify a safety signal in Avenue's clinical development program. In addition, the CRL stated that the FDA requires an adequate terminal sterilization validation prior to NDA approval, which is planned for later this quarter. "We believe that our extensive clinical database strongly supports the value of treatment with IV tramadol as an effective alternative to intravenous Schedule II conventional opioids. We firmly stand behind the safety data in our NDA and the ultimate approvability of IV tramadol," said Lucy Lu, MD, President and CEO of Avenue Therapeutics. "We will request a meeting with the FDA as soon as possible and are committed to working closely with the agency to resolve these issues in order to bring this important medicine to patients and clinicians in the U.S."
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LGND | Hot Stocks06:26 EDT HitGen enters agreement with Ligand to acquire Vernalis for $25M in cash - HitGen announces it has entered into a definitive agreement with Ligand Pharmaceuticals to acquire Vernalis Limited, Cambridge, UK-based world leaders in fragment and structure-based drug discovery research. The acquisition is for the entire issued share capital of Vernalis Limited, for $25M in cash. The closing of this transaction is subject to customary conditions and approvals, expected to complete before the end of 2020. Vernalis combines excellence in protein science and structure determination, fragment screening and biophysics with medicinal chemistry leadership to enable novel drug discovery against highly challenging targets. They are a 80-person experienced research team, working out of fully equipped laboratories in Granta Park, Cambridge.
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TANH | Hot Stocks06:15 EDT Tantech Holdings subsidiary receives $3.34M order from existing customer - Tantech Holdings announced its subsidiary, Zhejiang Tantech Bamboo Technology, received an order valued at $3.34M from an existing customer. Shipment under the multi-million dollar order will start this month and will complete within 5 months. The products, which were customized, will be mainly sold in Taiwan. They include activated carbon for water purification, far-infrared bamboo charcoal dehumidifying cushions and far-infrared height adjustable bamboo charcoal pillows. The customer is a global trading company, focusing on washing supplies, packaging materials, household products, environmental protection materials and more.
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AEYE | Hot Stocks06:09 EDT AudioEye appoints Bryan Rodrigues as CMO - AudioEye announced that Bryan Rodrigues has joined the company as CMO. Bryan brings 20 years of technology marketing experience to AudioEye, where he will be responsible for the company's branding and marketing efforts. He will report to interim CEO David Moradi and will join the senior leadership team in its mission to increase digital accessibility on the web. Most recently, Bryan was VP of marketing and e-commerce at Tile, helping drive growth of Tile's core business and playing a role in the company's expansion through partnerships and subscription services.
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BAND | Hot Stocks06:04 EDT Bandwidth to acquire Voxbone for EUR 446M - Bandwidth announced it has signed a definitive agreement to acquire Voxbone, an international enterprise cloud communications leader, for an enterprise value of EUR 446M, representing a multiple of approximately six times anticipated Voxbone 2020 revenue. Voxbone has been majority-owned by Vitruvian Partners since 2015. Voxbone is a European-based communications platform and IP voice network. The company said through this combination, Bandwidth will play an even greater role in leading the transformation of enterprise cloud communications, enabling companies around the world to develop, launch, and hyper-scale applications and customer experiences using rich voice and text. Enterprises everywhere in 2020 are prioritizing voice, video, and text communications in their digital transformations. IDC projects worldwide spending on communications as a service to be $17.7B by 2041. Upon close, Bandwidth will power 11 out of 12 of Gartner's magic quadrant leaders for UCaaS, CCaaS, and Meeting Solutions enterprises. The consideration to Voxbone shareholders will consist of cash in the amount of $400M with the remainder being paid in Bandwidth Class A common stock. The transaction is expected to close on October 31, and following the closing, Voxbone will operate under the Bandwidth brand.
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HLIO | Hot Stocks06:02 EDT Helios Technologies to acquire Balboa Water Group for $218.5M - Helios Technologies has entered into a definitive agreement to acquire BWG Holdings, operating as Balboa Water Group, for $218.5M from investment funds affiliated with AEA Investors. Helios plans to fund the Acquisition through a combination of cash and existing and new credit facilities. Helios expects to close the transaction in the fourth quarter, subject to customary closing conditions and regulatory approvals. Balboa is an innovative market leader of electronic controls for the health and wellness industry with proprietary and patented technology that enables end-to-end electronic control systems for therapy bath and spas. Headquartered in Costa Mesa, CA, Balboa is a global operation selling into 47 different countries and utilizing a new state-of-the-art manufacturing facility in Baja, Mexico. Balboa has delivered compounded annual growth in the mid-single digits for nearly 10 years and is expected to achieve Adjusted EBITDA margins of approximately 20 percent by year-end 2021. The Acquisition is expected to be accretive to Adjusted EPS day one onward, and the first year ROIC is expected to exceed Helios's WACC. The purchase price of $218.5M represents a 2020E Adjusted EBITDA transaction multiple of 9.3x on a pro forma basis.
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WIX VOD | Hot Stocks05:38 EDT Wix.com partners with Vodafone to help customers build online presence - Wix (WIX) has announced a partnership with Vodafone (VOD). Vodafone's business customers in the UK will be the first to benefit. Wix will be available via the Vodafone Business Marketplace platform, enabling Vodafone customers to build an online presence or online store. Vodafone customers can select a Wix subscription package that fits their needs, including launching a professional business website and adding online capabilities such as a store to sell products or online scheduling and appointment booking. In addition, customers will benefit from online access to a technician who will guide them through the steps of setting up their website including choosing a domain name, a website theme and the initial website design via Wix Artificial Design Intelligence, or Wix ADI, as well as training on website creation and maintenance.
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NTRS | Hot Stocks05:34 EDT Northern Trust selected by M&SPT to provide asset servicing solutions - Northern Trust announced it has been selected by Marks & Spencer Pension Trust, or M&SPT, in the UK to provide a range of asset servicing solutions to the M&S Pension Scheme, a defined benefit pension scheme of which M&SPT is trustee. With GBP 11B of assets as at March 31, the M&S Pension Scheme is one of the country's 25 largest corporate pension schemes. Northern Trust will provide global custody, financial reporting and analytical services to support M&SPT's oversight and administration of its investment strategy, across its range of traditional, insurance and alternative investments. These solutions include specialist fund administration and analytics for M&SPT's private market portfolio.
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DIS | Hot Stocks05:32 EDT Disney announces the return of Frozen Fan Fest - Disney announced Frozen Fan Fest is back with exclusive content, digital adventures and new toys, apparel, games, books and more inspired by the films from Walt Disney Animation Studios. This year includes a Virtual Playdate hosted by chef, two-time New York Times best-selling author, entrepreneur, television host and producer, Ayesha Curry, that will air on October 18. The digital event will be available for one day only. Participants will also get an exclusive first look at the trailer for "Once Upon a Snowman," the new short from Walt Disney Animation Studios, which debuts on Disney+ on October 23.
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ARGO | Hot Stocks05:29 EDT Argo Group enters RITC transaction with RiverStone with GBP 356M in provisions - ArgoGlobal, the Lloyd's insurer and member of Argo Group, announced a reinsurance-to-close, or RITC, transaction with legacy specialist RiverStone. Upon completion of the transaction, RiverStone will undertake an RITC of ArgoGlobal's Syndicate 1200 for 2017 and prior years with net technical provisions of GBP 356M. The transaction is expected to receive regulatory approval in Q4, with the RITC becoming effective on January 1, 2021.
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MASI | Hot Stocks05:26 EDT Masimo announces findings from Masimo ORi study at Anesthesiology 2020 - Masimo announced the findings of an abstract recently presented at Anesthesiology 2020, the annual meeting of the American Society of Anesthesiologists, or ASA. In this independent, retrospective study, researchers investigated whether Masimo ORi, or Oxygen Reserve Index, could predict whether children with obstructive sleep apnea syndrome, or OSAS, undergoing tonsillectomy required postoperative oxygen therapy. ORi, available outside the U.S., is a noninvasive and continuous parameter intended to provide insight into a patient's oxygen status during moderate hyperoxia. Enabled by the multi-wavelength rainbow Pulse CO-Oximetry platform, ORi is provided alongside oxygen saturation, or SpO2, a clinically proven Masimo SET pulse oximetry measurement. Yoshimi Inagaki and colleagues at Tottori University in Yonago, Japan sought to determine whether Masimo ORi could serve as a useful predictor of the need for postoperative oxygen therapy, or POT. They enrolled 45 pediatric patients with OSAS, ranging from seven to 120 months, who were anesthetized with sevoflurane and monitored with ORi while undergoing tonsillectomy. Of the 45 patients, 16 required POT. For those 16, the mean lowest ORi and SpO2 values were 0.28 and 93%, respectively. For the remaining patients, who did not receive POT, the mean lowest values were 0.64 and 97%, respectively. The researchers calculated sensitivity and specificity for ORi predicting when POT would not be needed of 0.815 and 0.9310, respectively. The researchers concluded that ORi is "likely to become an index of POT in pediatric patients with OSAS." They also noted, "In children with OSAS, [the] requirement of POT following tonsillectomy and adenoidectomy is probably able to be predicted on the basis of the results of this retrospective cohort study." ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
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TAK | Hot Stocks05:20 EDT Takeda Pharmaceutical announces interim results from VISIBLE OLE study - Takeda Pharmaceutical announced interim results from the VISIBLE open-label extension, or OLE, study on the long-term safety and efficacy of maintenance treatment with the subcutaneous, or SC, formulation of the gut-selective biologic Entyvio in patients with moderately to severely active ulcerative colitis, or UC. In evaluating the primary safety endpoint of the trial, interim data of the UC patient population showed that following two years of maintenance therapy with vedolizumab SC, long-term safety findings were consistent with the known safety profile of vedolizumab. Patients also continued to demonstrate clinical benefit from treatment, through maintenance of clinical remission and corticosteroid-free clinical remission rates, the clinical efficacy outcomes of the trial. These data were announced in an oral presentation at the UEG Week Virtual congress. VISIBLE OLE is an ongoing open-label, phase 3b, multinational, multicenter study to evaluate the long-term safety and tolerability of vedolizumab SC in adult patients with ulcerative colitis or Crohn's disease, or CD, following enrollment and participation in the VISIBLE 1, or UC, or VISIBLE 2, or CD, studies. Participants who completed the maintenance period up to week 52, or who achieved clinical response at week 14 after a third vedolizumab IV infusion at week 6, received vedolizumab SC 108 mg every two weeks. Interim data from the VISIBLE OLE study in the UC patient population demonstrated that adverse events were consistent with the known safety profile of vedolizumab. During two years of maintenance treatment, adverse events occurred in 69% of patients with UC, with disease exacerbations, nasopharyngitis, upper respiratory tract infection and anemia reported most frequently. Injection site reactions were reported in 4.5% of patients and all were mild or moderate in severity. Serious adverse events occurred in 14% of patients, with no cases of progressive multifocal leukoencephalopathy and no deaths. In randomized completers, rates of clinical remission and corticosteroid-free clinical remission were maintained up to week 108. In non-randomized week 14 responders, the comparative rates were 62.6% at week 14 and 33.3% at week 110 for clinical remission, and 24.5% at week 54 and 25% at week 110 for corticosteroid-free clinical remission.
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MAT | Hot Stocks05:16 EDT Mattel, Nelvana Studio to co-produce 104 new 'Thomas & Friends' episodes - Mattel announced that it has greenlit 104 11-minute episodes and two 60-minute specials for the "Thomas & Friends" television series over two seasons. The company has partnered with Corus Entertainment's Nelvana Studio, an international producer and distributor of children's animated and live-action content, to co-produce the series starting with Season 25, which will premiere beginning in Fall 2021, and will introduce a new creative approach to the show, contemporizing the series.
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MNK | Hot Stocks05:13 EDT Mallinckrodt voluntarily initiates Chapter 11 proceedings in bankruptcy court - Mallinckrodt announced that it has voluntarily initiated Chapter 11 proceedings in the U.S. Bankruptcy Court for the District of Delaware to modify its capital structure, including restructuring portions of its debt, and resolve several billion dollars of potential legal liabilities. Mallinckrodt and all of its subsidiaries are continuing to operate and supply customers and patients with products as normal. The entities that filed Chapter 11 petitions include Mallinckrodt, substantially all of its U.S. subsidiaries, including its specialty generics-focused subsidiaries and specialty brands-related subsidiaries, and certain of its international subsidiaries. The company intends to use the Chapter 11 process to provide a mechanism to implement a restructuring support agreement, or RSA, that, among other things, provides for an amended proposed opioid claims settlement and a financial restructuring that would: reduce the company's total debt by approximately $1.3B; resolve opioid-related claims against the company, its subsidiaries and related entities; and resolve various Acthar Gel-related matters, including the CMS Medicaid rebate dispute, an associated False Claims Act, or FCA, lawsuit and an FCA lawsuit relating to Acthar's previous owner's interactions with an independent charitable foundation. In connection with the Chapter 11 filing, the company has entered into an RSA that provides for a financial restructuring designed to strengthen the company's balance sheet and reduce its total debt by approximately $1.3B. Parties to the RSA include: Holders of approximately 84% of the company's guaranteed unsecured notes; 50 states and territories; and the court-appointed plaintiffs' executive committee representing the interests of thousands of plaintiffs in the opioid multidistrict litigation, or Opioid MDL, which has agreed to recommend that the more than 1,000 counties, municipalities, Native American tribes and other opioid claimants in the Opioid MDL support the RSA. Under the terms of the RSA, at the end of the court-supervised process: all allowed first lien credit agreement claims, first lien note claims and second lien note claims are expected to be reinstated at existing rates and maturities; holders of allowed guaranteed unsecured note claims are expected to receive their pro rata share of $375M of new secured second lien notes due seven years after emergence and 100% of new Mallinckrodt ordinary shares, subject to dilution by the warrants described below and certain other equity; trade creditors and holders of allowed general unsecured claims are expected to share in $150M in cash and equity holders and non-guaranteed unsecured noteholders are expected to receive no recovery. The company has reached an agreement in principle on the terms of an amended proposed settlement that would resolve opioid-related claims against Mallinckrodt and its subsidiaries and eliminate billions of dollars in alleged liabilities. The amended proposed settlement is supported by a broad array of opioid plaintiffs as detailed above. Under the terms of the amended proposed settlement, which would become effective upon Mallinckrodt's emergence from the Chapter 11 process, subject to court approval and other conditions: opioid claims would be channeled to one or more trusts, which would receive $1.6B in structured payments. A total of $450M would be received upon the company's emergence from Chapter 11; $200M would be received on each of the first and second anniversaries of emergence, and $150M would be received on each of the third through seventh anniversaries of emergence with a one-year prepayment option at a discount for all but the first payment. Opioid claimants would also receive warrants for approximately 19.99% of the Company's fully diluted outstanding shares, including after giving effect to the exercise of the warrants, exercisable at a strike price reflecting an aggregate equity value of $1.551B. Upon commencing the Chapter 11 filing, the company will comply with an agreed-upon operating injunction with respect to the operation of its opioid business. Mallinckrodt has reached an agreement in principle with certain governmental parties to resolve certain disputes relating to Acthar Gel. The agreement in principle is conditioned upon Mallinckrodt entering the Chapter 11 restructuring process. The company has agreed to pay $260M over seven years and reset Acthar Gel's Medicaid rebate calculation as of July 1, such that state Medicaid programs will receive 100% rebates on Acthar Gel Medicaid sales, based on current Acthar Gel pricing. Additionally, upon execution of the settlement, the company will dismiss its appeal of the CMS Medicaid rebate ruling currently pending in the U.S. Court of Appeals for the D.C. Circuit. The settlement would resolve the CMS Medicaid rebate dispute, the associated FCA lawsuit in Boston and an FCA lawsuit in the Eastern District of Pennsylvania relating to Acthar's previous owner's interactions with an independent charitable foundation. Mallinckrodt expects to complete the settlement over the next several months, subject to bankruptcy court approval. The current consolidated cash balance of the Chapter 11 filing entities is more than $650M. Together with cash generated from ongoing operations, this is expected to provide ample liquidity to support continued operations during the court-supervised process. The company has filed a number of customary motions seeking court authorization to continue to support its business operations during the court-supervised process, including the continued payment of employee wages and benefits without interruption. The company intends to pay vendors and suppliers in full under normal terms for goods received and services rendered on or after the filing date. The company expects to receive court approval for all of these routine requests. The company's foreign non-debtor affiliates will continue to operate their businesses in the ordinary course. Separating the specialty generics and specialty brands businesses remains one of Mallinckrodt's goals. The company will continue to evaluate strategic options for the Specialty Generics business at an appropriate time and when market conditions are favorable.
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MNK | Hot Stocks05:04 EDT Mallinckrodt voluntarily initiates Chapter 11 proceedings
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