Stockwinners Market Radar for September 29, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
PGNY | Hot Stocks20:19 EDT Progyny CEO sells 77.8K shares of common stock - In a regulatory filing, Progyny disclosed that its CEO David Schlanger sold 77.8K shares of common stock on September 25th in a total transaction size of $2.22M. The holding represents about 11% of his total owned.
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GOVX | Hot Stocks19:09 EDT GeoVax Labs CEO buys 82K shares, CFO buys 60K shares - In a regulatory filing, GeoVax disclosed that its CEO David Dodd bought 81,870 shares and CFO Mark Reynolds bought 60,184 shares of common stock in respective transaction sizes of $409K and $301K. Shares of GeoVax are up 17.2% at $3.47 in after-hours trading.
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SRGA | Hot Stocks19:05 EDT Surgalign to acquire Holo Surgical for up to $125M - Surgalign Holdings announces that it has entered into a definitive agreement to acquire Holo Surgical Inc., a Chicago-based private technology company developing Augmented Reality and Artificial Intelligence platform, to enable digital spine surgery. Total consideration for the transaction is valued at up to $125M, consisting of consideration valued at $42M payable at closing in cash and shares plus potential future milestone payments. The transaction is expected to close during the fourth quarter of 2020, subject to customary closing conditions.
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ETON | Hot Stocks18:51 EDT Eton Pharmaceuticals announces FDA approval of ALKINDI SPRINKLE - Eton Pharmaceuticals announced that the U.S. FDA has approved ALKINDI SPRINKLE (hydrocortisone) oral granules as replacement therapy for Adrenocortical Insufficiency in children under 17 years of age. ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for the treatment of adrenocortical insufficiency specifically designed for use in children.
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NEWA | Hot Stocks18:51 EDT Newater to be acquired by Crouching Tiger Holding for $3.65 per share - Newater Technology announced that it has entered into a definitive Agreement and Plan of Merger with Crouching Tiger Holding Limited, an exempted company with limited liability incorporated under the laws of the Cayman Islands, and Green Forest Holding Limited, a company with limited liability incorporated under the laws of the British Virgin Islands and a wholly-owned subsidiary of Parent, pursuant to which Parent will acquire the company for $3.65 per common share of the company. Subject to the terms and conditions of the Merger Agreement, at the effective time of the merger, Merger Sub will merge with and into the company, with the company continuing as the surviving corporation and becoming a wholly-owned subsidiary of Parent. At the Effective Time, each of the company's Common Shares, par value $0.001 per share, issued and outstanding immediately prior to the Effective Time will be cancelled in exchange for the right to receive $3.65 per share in cash and without interest, except for the excluded shares, which include shares beneficially owned by Mr. Li Yuebiao, Ms. Zhang Zhuo, and Mr. Sui Xiangqian, Shares owned by the holders of Shares who have validly exercised and not effectively withdrawn or lost their appraisal rights pursuant to Section 179 of the BVI Companies Act, 2004, as amended, and Shares (if any) owned by the company or any direct or indirect wholly-owned subsidiary of the company. Each Excluded Share issued and outstanding immediately prior to the Effective Time, by virtue of the merger and without any action on the part of its holder, shall be cancelled and shall cease to exist as of the Effective Time, and no consideration shall be delivered with respect thereto. The Merger, which is currently expected to close during the second quarter of 2021, is subject to customary closing conditions, including the approval by an affirmative vote of shareholders representing more than fifty percent of the outstanding Shares of the Company, present and voting in person or by proxy as a single class at a general meeting of the Company's shareholders duly convened to consider the approval of the Merger Agreement and the transactions contemplated thereby, including the Merger. As of the date of the Merger Agreement, the Rollover Shareholders have agreed under a voting agreement to vote all in favor of the Merger Agreement and consummation of the transactions contemplated thereby, including the Merger. If completed, the Merger will result in the Company becoming a privately held company and its Common Shares will no longer be listed on the NASDAQ Capital Market.
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MKC | Hot Stocks18:25 EDT McCormick CEO: Consumer segment seeing strong demand - In an interview on CNBC's Mad Money, Lawrence Kurzius said McCormick's household penetration is up 8% and the company has gained market share in most categories. Hot sauce was one of the strongest categories in Q3, growing 43%, Kurzius noted. The company is also seeing sustained consumer demand in China, Kurzius said. The 2-for-1 stock split was instituted to make shares more accessible to individual investors, according to Kurzius.
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MRNA | Hot Stocks18:20 EDT Moderna says COVID-19 vaccine candidate analysis published in NEJM - Moderna announced the publication of the second interim analysis of the open-label Phase 1 study of mRNA-1273, its vaccine candidate against COVID-19, in The New England Journal of Medicine. This interim analysis evaluated a two-dose vaccination schedule of mRNA-1273 given 28 days apart in 40 healthy adult participants across two dose levels in two age cohorts, and reports results through Day 57. This analysis found that both the 25 microgram and 100 microgram dose levels were generally well-tolerated in both age cohorts. Immune responses were dose-dependent with the 100 microgram dose eliciting higher binding and neutralizing antibody titers, supporting the selection of the 100 microgram dose for further study in the Phase 3 trial. The study was led by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. "These interim Phase 1 data suggests that mRNA-1273, our vaccine candidate for the prevention of COVID-19, can generate neutralizing antibodies in older and elderly adults at levels comparable to those in younger adults," said Tal Zaks, M.D., Ph.D., Chief Medical Officer of Moderna. "Given the increased morbidity and mortality of COVID-19 in older and elderly adults, these data give us optimism in demonstrating mRNA-1273's protection in this population, which is being evaluated in the Phase 3 COVE study."
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BNGO | Hot Stocks17:55 EDT Bionano Genomics announces adoption of Saphyr system in Australia and Slovenia - Bionano Genomics announced that its Saphyr system has been adopted through reagent-rental agreements by two renowned institutions in Australia and Slovenia: the Royal North Shore Hospital in Northern Sydney, New South Wales, Australia; and the University Medical Center Ljubljana in Ljubljana, Slovenia. Both hospitals aim to assess Saphyr's potential for diagnosing leukemias as compared to current standards of care, including karyotyping, chromosomal microarray and fluorescence in situ hybridization, or FISH.
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NOC | Hot Stocks17:38 EDT Northrop Grumman awarded maximum $249.3M Navy ordering agreement - Northrop Grumman was awarded a maximum ceiling $249.3M, firm-fixed-price and cost-plus-fixed-fee basic ordering agreement for the procurement of sustainment engineering and logistics services for ground/air task-oriented radar. This agreement includes engineering changes, technical refresh, studies and analyses, and the following support services: contractor logistics, depot lifecycle, software support activity, diminishing manufacturing sources and material shortages. Work locations will be determined by individual task orders and is expected to be complete by September 28, 2025. No funds will be obligated at the time of award. Funds will be obligated on individual task orders as they are issued. The agreement was not competitively procured pursuant to Federal Acquisition Regulation 6.302-1. Marine Corps Systems is the contracting activity.
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REGN | Hot Stocks17:37 EDT Regeneron rises 2.2% after REGN-COV2 antibody cocktail lowers viral levels
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HCYT | Hot Stocks17:35 EDT H-CYTE CEO William Home steps down, Robert Greif succeeds - H-CYTE announced that Robert Greif has been named the company's new CEO. Greif joins H-CYTE with experience in pharmaceutical and biotech businesses. Most recently, he was chief commercial officer and business development leader at Atox Bio, where he built the North American commercial organization in preparation for the launch of an immunomodulator. Greif joins H-CYTE as CEO and president effective immediately. He replaces William Horne, who is stepping down as CEO but will remain on the company's board.
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AEM NEM | Hot Stocks17:33 EDT Agnico Eagle announces exploration joint venture with Newmont - Agnico Eagle Mines Limited (AEM) announced that it has formed an exploration joint venture in Colombia with Newmont Corporation (NEM). The 50-50 joint venture, which will be operated by Agnico Eagle, will explore the Anza project and seek other prospective gold targets of district-scale potential in Colombia. Agnico Eagle will sole fund the joint venture until expenditures equal Newmont's previous investment in the Anza project, approximately $2.9M, which is expected to be achieved in the next 12 months. Thereafter the parties will continue funding on a 50-50 basis.
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MD | Hot Stocks17:22 EDT Mednax CFO Stephen Farber to depart company effective October 1st - MEDNAX entered into an employment agreement with Mr. C. Marc Richards, the company's Executive Vice President , pursuant to which Mr. Richards will assume the additional roles of CFO and Principal Financial Officer of the company, effective October 1, 2020. Mr. Richards will succeed Mr. Stephen D. Farber, who will depart as Executive Vice President, CFO and Principal Financial Officer of the company, effective October 1, 2020.
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GH | Hot Stocks17:18 EDT Guardant Health chairman sells 75K shares of common stock - In a regulatory filing, Guardant Health disclosed that its president and chairman of the board Amirali Talasaz sold 75K shares of common stock on September 25th in a total transaction size of $8.3M. The holding represents about 2% of his total owned.
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MRNA | Hot Stocks17:14 EDT Moderna up over 3% after report expanding COVID vaccine trial to older subjects
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MRNA | Hot Stocks17:13 EDT Moderna's COVID vaccine 'well tolerated' with immune response, NIAID reports - According to NIAID, "Moderna's Phase 1 trial of its mRNA vaccine to prevent COVID-19 has shown to be "well-tolerated and generates a strong immune response in older adults. In its expansion to include older adults, the trial enrolled 40 healthy volunteers: 20 adults ages 56 to 70 years, and 20 adults ages 71 years and older. Ten volunteers in each age group received a lower dose of the vaccine, and 10 volunteers in each age group received a higher dose (100 microgram). After approximately one month, volunteers then received a second dose of the same vaccine at the same dosage. Throughout the study, volunteers attended clinic visits to track their responses to the vaccine and assess safety... The study will continue to follow the older volunteers for approximately a year after second vaccination to monitor the long-term effects of the vaccine." Reference Link
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LOW | Hot Stocks17:07 EDT Lowe's to restart its stock repurchase program - On September 29, 2020, Lowe's determined to restart its previously authorized stock repurchase program, which was temporarily suspended in Q1 of 2020 in response to the uncertainties surrounding the COVID-19 pandemic. The company currently has $8.7B remaining under the board's repurchase authorization.
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WMT ORCL | Hot Stocks17:06 EDT TikTok rolls out in-app guide to U.S. elections - TikTok said in a blog post that it is launching an in-app guide to the 2020 U.S. elections to provide access to authoritative information as we continue our work to protect against misinformation. The guide connects 100M Americans with trusted information about the elections from the National Association of Secretaries of State, BallotReady, SignVote, and more, the company said. Rolling out to users in the US beginning today, the elections guide offers information about candidates at the federal, state, and local level, powered by BallotReady; how to vote in every state, powered by the National Association of Secretaries of State; and educational videos about misinformation, media literacy, the elections process, and more, powered by MediaWise. The Fly notes that TikTok owner ByteDance has said it reached a preliminary agreement for Walmart (WMT) and Oracle (ORCL) to acquire stakes in TikTok. Reference Link
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OII | Hot Stocks17:05 EDT Oceaneering says ADTech unit secures contract with NAVSEA with $119M potential - Oceaneering International announced that its Aerospace and Defense Technologies, ADTech, segment has secured a contract with Naval Sea Systems Command, NAVSEA, to operate and maintain the U.S. Navy's submarine rescue systems. The contract duration is one year, with four one-year extension options, with a potential value of $119M.Oceaneering's scope of work is to engage with the U.S. Navy's Undersea Rescue Command, based at Naval Air Station North Island in San Diego, California, to maintain, certify and operate submarine rescue systems and supporting equipment. For over 20 years, Oceaneering has supported the U.S. Navy Submarine Rescue program with significant engineering efforts and capability enhancements. This new contract represents significant growth in Oceaneering's role in supporting operations and maintenance.
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MSFT | Hot Stocks17:04 EDT Microsoft: Most nation-state hacks in last year came from Russia, Iran, China - Microsoft released a new annual report, called the Digital Defense Report, covering cybersecurity trends from the past year. This report makes it clear that threat actors have rapidly increased in sophistication over the past year, using techniques that make them harder to spot and that threaten even the savviest targets, the company said. For example, nation-state actors are engaging in new reconnaissance techniques that increase their chances of compromising high-value targets, criminal groups targeting businesses have moved their infrastructure to the cloud to hide among legitimate services, and attackers have developed new ways to scour the internet for systems vulnerable to ransomware. In addition to attacks becoming more sophisticated, threat actors are showing clear preferences for certain techniques, with notable shifts towards credential harvesting and ransomware, as well as an increasing focus on Internet of Things devices, Microsoft noted. Additionally, Microsoft said it observed 16 different nation-state actors either targeting customers involved in the global COVID-19 response efforts or using the crisis in themed lures to expand their credential theft and malware delivery tactics. These COVID-themed attacks targeted prominent governmental health care organizations in efforts to perform reconnaissance on their networks or people. Academic and commercial organizations involved in vaccine research were also targeted. "In recent years there has been an important focus on vulnerabilities in critical infrastructure," the company said. "While we must remain vigilant and continue to increase security for critical infrastructure, and while these targets will continue to be attractive to nation-state actors, in the past year such actors have largely focused on other types of organizations. In fact, 90% of our nation-state notifications in the past year have been to organizations that do not operate critical infrastructure. Common targets have included nongovernmental organizations (NGOs), advocacy groups, human rights organizations and think tanks focused on public policy, international affairs or security. This trend may suggest nation-state actors have been targeting those involved in public policy and geopolitics, especially those who might help shape official government policies. Most of the nation-state activity we observed the past year originated from groups in Russia, Iran, China and North Korea." Reference Link
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CVNA ALLY | Hot Stocks17:02 EDT Ally increases Carvana's loan purchase commitment by $1B - Carvana (CVNA0 announced a $1.0B increase to its current loan sale program with Ally Financial (ALLY). This increase represents a total of $3.0B in commitment to fund Carvana customer loans since March 2020. In addition to the increased loan purchase commitment, Ally Financial has also increased its commitment to provide funding through Carvana's inventory floor plan from $950M to $1.25B and has extended the facility from October 2020 through March 2023.
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MU | Hot Stocks17:01 EDT Micron sees FY21 capital expenditures $9B
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DEI | Hot Stocks16:52 EDT Douglas Emmett CEO buys 39.3K shares of common stock - In a regulatory filing, Douglas Emmett disclosed that its CEO Jordan Kaplan bought 39.3K shares of common stock on September 25th in a total transaction size of $997.4K.
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BCBP | Hot Stocks16:47 EDT BCB Bancorp completes sale and leaseback of corporate offices - BCB Bancorp, the holding company for BCB Community Bank, announced that the Bank completed the sale and leaseback of its corporate offices to a local investor group. The sale transaction consists of one city-block of property, located at 591-611 Avenue C in Bayonne, New Jersey, which includes the Company's executive offices, a parking lot, and a bank branch. The Company anticipates to realize a pre-tax gain of approximately $4.4M on the sale. In the lease transaction, the Bank will lease back the property for an initial term of seven years and will have four optional terms of five years each. The base annual rent will be $450,000, subject to annual rent increases of 2.5%. We expect to be able to offset a substantial portion of this rental expense with the elimination of depreciation expense on the property.
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MU | Hot Stocks16:46 EDT Micron says short-term outlook has weakened - Says short-term outlook weaker on enterprise spending. Says NAND flash market risks oversupply in 2021. Says cloud, laptop demand continues to be healthy. Says short-term outlook has weakened due to pandemic and weakened enterprise demand due to lower IT spending and somewhat higher inventories at some customers. Says halted shipments to Huawei on September 14. Says expects to offset impact by end of Q2 of 2021. Comments taken from Q4 earnings conference call.
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CPRX | Hot Stocks16:42 EDT Catalyst Pharmaceuticals gets adverse ruling in case against FDA, will appeal - The company states: "Catalyst Pharmaceuticals reported that the federal judge handling Catalyst's case against the FDA has adopted the previously reported Report and Recommendation of the Magistrate Judge, granted summary judgment in favor of the FDA and Jacobus, and dismissed Catalyst's case. Catalyst is currently reviewing the District Judge's decision, which it believes to be erroneous, and intends to appeal the result to the Eleventh Circuit Court of Appeals. In the order, the District Judge found that Catalyst's interpretation of the Orphan Drug Act "is not necessarily wrong, but it is not the only reasonable way to interpret the plain language of the statute." The District Judge found that the relevant statutory language was ambiguous and adopted FDA's interpretation rather than Catalyst's. The District Judge also rejected Catalyst's argument that the approved labeling for Ruzurgi is false and misleading. As a result of the District Judge's decision, Ruzurgi remains approved for the treatment of pediatric LEMS patients in the United States."
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MU | Hot Stocks16:41 EDT Micron shares turn negative, down 1.6% after providing DRAM, NAND outlook
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MU | Hot Stocks16:40 EDT Micron provides NAND, DRAM company outlook - Sees CY-20 DRAM bit supply growth expected to be above industry demand. Sees CY-21 bit supply growth moderate to less than industry demand. Sees long-term Micron bit supply growth CAGR in line with industry demand. Sees FY-21 cost reductions in mid-single-digit percent range,impacted by mix. Sees CY-20 NAND bit supply growth expected to be well below industry demand. Sees CY-21 bit supply growth expected to grow somewhat below industry demand. Sees long-term Micron bit supply growth CAGR in line with industry demand. Sees FY21 cost reductions expected to be in the low-to-mid-teens percent range, impacted by mix.
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CVAC | Hot Stocks16:38 EDT CureVac spikes up 9.5% to $50 per share after initiating COVID vaccine ph2 trial
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MU | Hot Stocks16:38 EDT Micron provides DRAM, NAND industry outlook - Sees CY20 DRAM industry bit demand growth in the mid-teens percent range with supply constraints for 8Gb-based DRAM products. Sees CY-21 industry bit demand growth of approximately 20%; disciplined industry capex to result in improving market conditions in 2H CY-21. Sees long-term DRAM bit demand growth CAGR of mid-to-high teens. Sees CY-20 NAND industry bit demand growth in the mid-20s, with supply and demand roughly balanced. Sees CY-21 industry bit demand growth of approximately 30%; risk of some excess supply unless industry capex moderates. Sees long-term NAND bit demand growth CAGR of approximately 30%. Comments taken from Q4 prepared remarks.
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CVAC | Hot Stocks16:37 EDT CureVac initiates phase 2a trial for COVID vaccine candidate CVnCoV - CureVac announced that the first participant has been dosed in a Phase 2a clinical trial of its COVID-19 vaccine candidate, CVnCoV. The dose-confirmation study, entitled CV-NCOV-002, is being conducted in Peru and Panama and will enroll a total of 690 healthy participants in two distinct groups: older adults ages 61 and above, and younger participants 18 to 60 years old. The participants will receive two vaccinations at intervals of 28 days. Different dose levels will be investigated, starting at 6 microgram, with the aims to confirm safety and evaluate reactogenicity of the vaccine in older adults. In addition, in a geographical environment with a high incidence of COVID-19 infection, the humoral immune response after administration of CVnCoV will be assessed and the safety database will be expanded to prepare for the start of a phase 2b/3 study. First comprehensive data of Phase 2a in older adults are expected later in the fourth quarter 2020. The study design was coordinated with and approved by the health authorities and ethics committees of Peru and Panama and is based on preliminary safety and immunogenicity data from CureVac's ongoing Phase 1 CV-NCOV-001 study in healthy adult volunteers in Germany and Belgium. Pending further data from the ongoing Phase 1 and the Phase 2a study, CureVac plans to initiate the global Phase 2b/3 clinical trial enrolling approximately 30,000 participants in the fourth quarter of 2020.
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PENN | Hot Stocks16:33 EDT Penn National backs Q3 guidance for revenue, adjusted EBITDAR - Penn National Gaming announced that it has closed on its underwritten public offering of 16.1M shares of its common stock, which includes 14M shares of its common stock initially offered by the company and 2.1M shares of its common stock issued pursuant to the option granted the underwriters, which the underwriters exercised in full on September 25. Penn National currently continues to expect Q3 consolidated revenues will range from $1.04B-$1.145B and Q3 consolidated adjusted EBITDAR will range from $410M-$450M, consistent with the ranges previously reported in its prospectus supplement. Jay Snowden, President and CEO of Penn National, added: "In short, we believe our company is incredibly well positioned for long-term success based on its highly differentiated approach to both land-based and interactive gaming and sports betting." Pro forma for the transaction, as of June 30, 2020, the company had net traditional debt of approximately $1B, "representing a significant reduction from pre-COVID-19 periods," Penn National said.
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AVAV | Hot Stocks16:31 EDT AeroVironment partners with Robot Skies for drone maintenance support - AeroVironment announced a teaming agreement with Robotic Skies, a global maintenance, repair, and overhaul network for UAS, to provide field maintenance, inspection and repair support for AeroVironment customers. Robotic Skies, through teaming agreements with companies such as AeroVironment, provides UAS fleet operators with local, aviation-grade maintenance services. "Our customers rely on AeroVironment's market-leading unmanned aircraft systems to perform critical missions, making timely field maintenance and local support essential," said Rick Pedigo, AeroVironment vice president of sales and business development. "By teaming with Robotic Skies, our valued customers can expect an even higher level of responsiveness and customer service through a broad service center network, which comprises 200 independently owned and operated, certified repair stations. This relationship will enable our customers to keep their UAS in operation, maximizing their productivity."
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PENN | Hot Stocks16:30 EDT Penn National says Barstool Sportsbook momentum has continued into second week - Penn National Gaming announced that it has closed on its underwritten public offering of 16.1M shares of its common stock, which includes 14M shares of its common stock initially offered by the company and 2,100,000 shares of its common stock issued pursuant to the option granted the underwriters, which the underwriters exercised in full on September 25. "This successful offering provides our company with additional resources to accelerate our unique omni-channel strategy, including launching the Barstool Sportsbook app in new markets, developing new products and features, establishing Barstool-branded sports bars and retail sportsbooks and reimagining the customer experience at our casinos, all while fortifying our balance sheet... On September 18, we officially introduced the Barstool Sportsbook app in the state of Pennsylvania, which broke records for the most downloads ever for the launch of a new mobile sportsbook, and it generated impressive handle. This momentum has continued into our second week of operation, as this weekend's handle grew by 14% over our initial weekend despite continuing to spend $0 in external marketing. In addition, we are extremely pleased with the operating performance of our properties this quarter, despite continued occupancy restrictions," said Jay Snowden, President and CEO of Penn National.
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SNX | Hot Stocks16:29 EDT Synnex up 4% to $137.50 after Q3 results, Q4 guidance beat estimates
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BKI | Hot Stocks16:29 EDT Black Knight General Counsel sell $5M in common stock - In a regulatory filing, Black Knight disclosed that its General Counsel Michael Gravelle sold 59.2K shares of common stock on September 25th in a total transaction size of $5.01M. The holding represents about 41% of his total owned.
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BIIB | Hot Stocks16:26 EDT Biogen 'looks forward' to engaging meaningfully with ICER - Biogen said, "In 2020, the cost of Alzheimer's in the U.S. is estimated to be over $500 billion, impacting countless patient, family and caregiver lives. If approved, aducanumab may slow clinical decline and potentially help patients maintain independence longer. This could constitute an important breakthrough, after more than 100 clinical programs that have failed in this space. We look forward to engaging meaningfully with ICER and other stakeholders to help ensure that appropriate considerations and data representing the substantial cost and impact to patients, families, and society, as well as the benefits of aducanumab, are applied appropriately and transparently. The aducanumab Biologics License Application is the first for a product that aims to slow the clinical decline of Alzheimer's disease, as well as one of its hallmarks, the buildup of amyloid plaque. The BLA is currently under priority review with the FDA. As pioneers in neuroscience, we aim to bring transformative treatments to patients and are deeply committed to making ongoing investments in the science and research required to create breakthrough therapies. We recognize that prices for these treatments - and the ability of patients to obtain access to them - are important concerns for patients, physicians, payers, and policy makers, and we are dedicated to engaging with all stakeholders in a constructive dialogue about innovation, price, and access."
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BIIB | Hot Stocks16:25 EDT Biogen confirms FDA to convene advisory committee on aducanumab - Biogen issued the following statement: "On September 29, 2020, it was published in the Federal Register that the U.S. Food and Drug Administration will convene a virtual advisory committee meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to review data supporting the Biologics License Application - BLA - for aducanumab, an investigational product for Alzheimer's disease. The advisory committee meeting is scheduled for November 6, 2020 and will be available for live streaming. The notice stated that the FDA intends to make the advisory committee meeting's background materials and pre-recorded presentations available to the public no later than two business days before the meeting. The notice also stated that, if the FDA is unable to post the background materials and/or pre-recorded presentations on its website prior to the advisory committee meeting, the background material and/or pre-recorded presentations will be made publicly available on the FDA's website at the time of the advisory committee meeting. The notice stated that the advisory committee meeting will include brief summaries of the pre-recorded presentations, discussion and oral presentations from the public." Reference Link
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FUSN | Hot Stocks16:19 EDT Fusion Pharma appoints Maria Stahl as Chief Legal Officer - Fusion Pharmaceuticals announced the appointment of Maria Stahl as Chief Legal Officer. Prior to joining Fusion, Stahl held executive leadership roles at Tetraphase Pharmaceuticals, including chief business officer and general counsel. Before joining Tetraphase, Stahl was the senior vice president, general counsel of Idenix Pharmaceuticals. Ms. Stahl began her career with the law firm Wilmer Cutler Pickering Hale and Dorr. Stahl holds a bachelor of arts from Providence College and a juris doctorate from Yale Law School.
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MU | Hot Stocks16:19 EDT Micron rises 2.5% after Q4 earnings beat
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EGBN | Hot Stocks16:19 EDT Eagle Bancorp lifts suspension of share repurchase program - Eagle Bancorp announced that the company's board has approved lifting the suspension of the company's share repurchase program. The company's share repurchase program was previously suspended during Q1.
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SNX | Hot Stocks16:18 EDT Synnex CEO says 'on track with the proposed spin-off of Concentrix' - "Our strong third quarter performance is a reflection of our resiliency, our ongoing focus on serving our partners and clients and the continued dedication of our associates on the growth and improvement of our business during these unprecedented times," said Dennis Polk, SYNNEX President and CEO. "We remain on track with the proposed spin-off of Concentrix and believe this will result in incremental value for all of our stakeholders."
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FROG ZS | Hot Stocks16:17 EDT JFrog appoints Micheline Nijmeh as chief marketing officer - JFrog (FROG) announced the appointment of Micheline Nijmeh as its chief marketing officer, or CMO. Nijmeh has experience in developing global marketing strategies to drive revenue for enterprise technology companies. Nijmeh was most recently the senior vice president and chief marketing officer at Zscaler (ZS).
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NEE | Hot Stocks16:17 EDT NextEra Energy subsidiary to acquire GridLiance for $660M - NextEra Energy Transmission, a subsidiary of NextEra Energy, announced it has entered into definitive agreements with affiliates of Blackstone to acquire GridLiance Holdco, and GridLiance for approximately $660M, including the assumption of debt. A portion of the net proceeds from NextEra Energy's recent equity units issuance will be used to finance the transaction. GridLiance owns approximately 700 miles of high-voltage transmission lines and related equipment with utility rates set by the Federal Energy Regulatory Commission, or FERC. The company's assets span three regional transmission organizations and six states. The transaction requires approval from the FERC, utility commissions in Kansas, Missouri, and Oklahoma, as well as expiration or termination of the waiting period under the Hart-Scott-Rodino Act. Assuming timely regulatory approvals, the transaction is expected to close in 2021. Wells Fargo Securities, served as financial advisor, and Pillsbury Winthrop Shaw Pittman LLP served as counsel to NextEra Energy Transmission.
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TDC | Hot Stocks16:16 EDT Teradata names Nicolas Chapman chief strategy officer - Teradata announced the appointment of Nicolas Chapman as Teradata's Chief Strategy Officer. In this newly created position, Chapman will be responsible for working collaboratively across the organization to develop Teradata's strategic plan, annual operating plan, as well as the ongoing measurement and refinement needed to achieve the company's strategic goals. "As we execute across the company to be cloud-first and accelerate our position as a profitable growth company, we must ensure that we have a well-defined strategic and operational plan that guides our way," said Steve McMillan, CEO at Teradata. "Nicolas has a proven track record in accelerating organizational performance through cohesive strategy planning and execution. Teradata has made solid progress on this front over the last several years and Nicolas will help us build on our momentum."
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TNXP | Hot Stocks16:14 EDT Tonix ito complete Relief study of TNX-102 SL for fibromyalgia - Tonix Pharmaceuticals Holding announced the outcome of the pre-planned interim analysis for the Phase 3 RELIEF study of TNX-102 SL 5.6 mg for the management of fibromyalgia. An independent statistical team conducted the unblinded interim analysis of the primary endpoint of the first 50 percent of randomized participants who entered the 14-week study. Based on the interim results and the prespecified sample size re-estimation, the independent data monitoring committee, IDMC, made the non-binding recommendation that the trial continue to completion with the addition of 210 participants to the original sample size of 470 participants, which is the maximum number of participants that could be added under the interim statistical analysis plan. Based on this information, the Company plans to complete the study with the 503 currently enrolled participants and to report topline results in the fourth quarter of 2020. The Company remains blinded to the interim analysis results. "We plan to complete the Phase 3 RELIEF study without adding new participants," commented Seth Lederman, M.D., President and Chief Executive Officer. "We started enrolling RELIEF in December 2019 and continued to enroll and study fibromyalgia sufferers through the onset and progression of the COVID-19 pandemic. We made changes to the protocol to conform to the U.S. Food and Drug Administration's (FDA's) guidance on research during the COVID-19 public health emergency. We need to consider the possibility that the onset of the COVID-19 pandemic affected both the reporting and variability of fibromyalgia symptoms in the interim analysis cohort, or first half, of the RELIEF participants in a way that was not anticipated prior to the pandemic. It is also possible that the second half of the RELIEF participants, enrolled after April 22, 2020, may have been affected by the ongoing nature of the pandemic, but differently than the first half which comprised the interim analysis cohort."
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TPRE AIG | Hot Stocks16:12 EDT Third Point Reinsurance names David Junius as COO - Third Point Reinsurance (TPRE) announced that David Junius has been appointed COO, effective October 1. Upon the company's anticipated closing of its merger transaction with Sirius International Insurance Group Ltd., Junius will be appointed CFO of the company, to be renamed SiriusPoint Ltd. Junius brings more than 23 years of industry experience to his new role having most recently served as the CFO for the International division of the General Insurance segment at American International Group (AIG).
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CTIC | Hot Stocks16:06 EDT CTI BioPharma to submit NDA for accelerated approval of pacritinib - CTI BioPharma announced that following a recent Pre-NDA meeting with the U.S. FDA, the company has reached an agreement to submit an NDA for the potential accelerated approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia. The NDA will be based on the available data from the company's completed Phase 3 PERSIST-1 and PERSIST-2 trials and the Phase 2 PAC203 dose-ranging trial. The FDA has agreed to a rolling NDA submission which is expected to commence within a few weeks, with completion of the NDA submission anticipated in the first quarter of 2021. The ongoing Phase 3 PACIFICA trial is expected to be completed as a post-marketing commitment.
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AMP | Hot Stocks16:05 EDT Ameriprise announces additional $2.5B share repurchase authorization - The board of directors of Ameriprise Financial, Inc. has authorized an additional $2.5B for the repurchase of shares of its common stock through September 30, 2022. As of June 30, 2020, the company had approximately $500M available from its February 2019 authorization, which is available through March 31, 2021. The company intends to fund share repurchases through existing working capital, future earnings and other customary financing methods. The share repurchase program does not require the purchase of any minimum number of shares, and depending on market conditions and other factors, these purchases may be commenced or suspended at any time without prior notice. Acquisitions under the share repurchase program may be made in the open market, through privately negotiated transactions or block trades or other means.
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WSTL | Hot Stocks16:04 EDT Westell Technologies shareholders approve 1-for-1,000 reverse stock split - Westell Technologies announced that at the Annual Meeting on September 29,the company's stockholders voted to approve proposals authorizing the Board of Directors of the Company to amend the Company's certificate of incorporation to effect a 1-for-1,000 reverse stock split of the Company's Class A and Class B Common Stock, followed immediately by an 1,000-for-1 forward stock split. The reverse and forward stock splits will be effected on October 1 and the company's Class A Common Stock is expected to begin trading on the NASDAQ Capital Market on a post-forward stock split basis upon the opening of trading on October 2. As a result of the reverse stock split, each share of the Company's Common Stock held by a stockholder of record owning immediately prior to the effective time of the reverse stock split fewer than 1,000 shares of the Company's Common Stock will be converted into the right to receive $1.48 in cash, without interest, and such stockholders will no longer be stockholders of the Company. To be entitled to such cash payment, a stockholder must be a record holder of fewer than 1,000 shares immediately prior to the effective time of the reverse stock split. Investors who purchase fewer than 1,000 shares prior to the effective time of the reverse stock split and settle such purchases after the effective time shall not be entitled to such cash payment and instead their trades will be settled on a post-forward stock split basis. Trades in the Company's Common stock made on or after October 1, 2020 will settle on a post-forward stock split basis.
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CMTL | Hot Stocks16:03 EDT Comtech announces $100M stock repurchase program - Comtech Telecommunications Corp. announced that its board of directors has authorized a new $100M share repurchase program pursuant to which the company may repurchase shares of its common stock from time to time in open market transactions at prevailing market prices, in privately negotiated transactions, or by other means in accordance with federal securities laws. "Authorizing the use of our strong balance sheet for share repurchases demonstrates our confidence in the underlying value of our stock and our commitment to providing long-term value for our stockholders," commented Fred Kornberg, Chairman and Chief Executive Officer of the Company.
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REGN | Hot Stocks16:03 EDT Regeneron says REGN-COV2 antibody cocktail reduced viral levels in Phase 1/2/3 - Regeneron announced the first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its investigational antibody cocktail REGN-COV2 showing it reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. REGN-COV2 also showed positive trends in reducing medical visits. The ongoing, randomized, double-blind trial measures the effect of adding REGN-COV2 to usual standard-of-care, compared to adding placebo to standard-of-care. This trial is part of a larger program that also includes studies of REGN-COV2 for the treatment of hospitalized patients, and for prevention of infection in people who have been exposed to COVID-19 patients. "After months of incredibly hard work by our talented team, we are extremely gratified to see that Regeneron's antibody cocktail REGN-COV2 rapidly reduced viral load and associated symptoms in infected COVID-19 patients," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "The greatest treatment benefit was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally-occurring immune response. These patients were less likely to clear the virus on their own, and were at greater risk for prolonged symptoms. We are highly encouraged by the robust and consistent nature of these initial data, as well as the emerging well-tolerated safety profile, and we have begun discussing our findings with regulatory authorities while continuing our ongoing trials. In addition to having positive implications for REGN-COV2 trials and those of other antibody therapies, these data also support the promise of vaccines targeting the SARS-CoV-2 spike protein." The descriptive analysis included the first 275 patients enrolled in the trial and was designed to evaluate anti-viral activity with REGN-COV2 and identify patients most likely to benefit from treatment; the next cohort, which could be used to rapidly and prospectively confirm these results, has already been enrolled. Patients in the trial were randomized 1:1:1 to receive a one-time infusion of 8 grams of REGN-COV2 (high dose), 2.4 grams of REGN-COV2 (low dose) or placebo. All patients entering the trial had laboratory-confirmed COVID-19 that was being treated in the outpatient setting. Patients were prospectively characterized prior to treatment by serology tests to see if they had already generated antiviral antibodies on their own and were classified as seronegative (no measurable antiviral antibodies) or seropositive (measurable antiviral antibodies). Approximately 45% of patients were seropositive, 41% were seronegative and 14% were categorized as "other" due to unclear or unknown serology status.
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GLPG | Hot Stocks16:03 EDT Galapagos announces first patient dosed in psoriasis trial - Galapagos announced dosing of a first patient in their psoriasis trial, one of three patient trials currently recruiting to evaluate efficacy and safety of Toledo compound GLPG3970. Furthermore, Galapagos plans to unveil the novel Toledo target class and share GLPG3970 Phase 1 data at its inaugural Toledo Roundtable to be held virtually on October 27.
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CTIC | Hot Stocks16:02 EDT CTI BioPharma trading halted, news pending
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REGN | Hot Stocks16:01 EDT Regeneron trading halted, news pending
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GDDY FB | Hot Stocks15:49 EDT GoDaddy says customers can now sell products on Instagram, Facebook through W+M - GoDaddy (GDDY) announced earlier that customers can now sell their products on Instagram and Facebook (FB) through Websites + Marketing Ecommerce, "further expanding the opportunity for them to find new customers and grow sales." GoDaddy added: "As an official Facebook Marketing Partner, GoDaddy is one of the early adopters of Facebook's Business Extension... To make the most of the social commerce opportunity for small businesses, Websites + Marketing will integrate with Instagram Checkout and more automated Facebook Shops on-boarding in the near future."
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ITHUF | Hot Stocks15:44 EDT iAnthus provides update on fairness hearing for recapitalization transaction - iAnthus provided an update with respect to the fairness hearing for the company's plan of arrangement voted on by securityholders on September 14 to implement the company's previously announced recapitalization transaction. iAnthus appeared before Justice Gomery of the Supreme Court of British Columbia on September 25 for the fairness hearing and on September 28, Justice Gomery delivered his reasons for the decision orally. Justice Gomery indicated that his reasons are expected to be reduced to writing and released. Justice Gomery held that the plan of arrangement was put forward in good faith and met the statutory requirements of the British Columbia Business Corporations Act, or BCBCA. Justice Gomery was also satisfied that the plan of arrangement had a valid business purpose and was approved by the securityholders in accordance with the requirements of the BCBCA. The plan of arrangement included a release of claims and Justice Gomery did not approve the form of release of claims presented to the court. Justice Gomery invited iAnthus and the parties to the restructuring support agreement, or RSA, to consider whether some other form of release language may be presented and ruled, in part, that: "...It is possible that iAnthus and the noteholders may agree to amend the plan to narrow the release and injunction to the point of acceptability. To preserve that possibility, I do not dismiss the petition. I grant iAnthus liberty to apply, if it thinks fit, on the basis of an amended plan of arrangement. I am seized of any further applications on this matter." Accordingly, Justice Gomery will have conduct of the matter and has not made a final ruling on the fairness of the plan of arrangement. Under the RSA, iAnthus is obligated to pursue the recapitalization transaction under the Companies' Creditors Arrangement Act within five business days if the final court order for the plan of arrangement was not granted by September 28. The parties to the RSA have agreed to extend the deadline to October 6.
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GDDY | Hot Stocks15:44 EDT GoDaddy announces integration of content design app into Websites + Marketing - GoDaddy announced earlier that its content design app, Over by GoDaddy, is now "deeply integrated" into Websites + Marketing. "This enables anyone to easily create impactful visuals right inside of Websites + Marketing, its website builder and set of marketing tools," the company stated. The new Over features will be available to users of all Websites + Marketing tiers. GoDaddy VP Product Matt Winn added: "Websites + Marketing was built to make it easy for entrepreneurs to show up everywhere that matters, from Amazon to Google to Facebook. But it's not enough to just show up. They need to look great too. Our integration with Over's powerful design tools means that anyone can create polished content, regardless of their graphic design experience. It's one more way to make sure a business gets noticed online, without requiring a huge investment of time or money for entrepreneurs."
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NVDA VMW | Hot Stocks15:10 EDT VMware, Nvidia partner over enterprise AI - VMware (VMW) and Nvidia (NVDA) announced a broad partnership to deliver both an end-to-end enterprise platform for AI and a new architecture for data center, cloud and edge that uses NVIDIA DPUs to support existing and next-generation applications. Through this collaboration, the rich set of AI software available on the NVIDIA NGC hub will be integrated into VMware vSphere, VMware Cloud Foundation and VMware Tanzu. This will help accelerate AI adoption, enabling enterprises to extend existing infrastructure for AI, manage all applications with a single set of operations, and deploy AI-ready infrastructure where the data resides, across the data center, cloud and edge. "We are partnering with NVIDIA to bring AI to every enterprise; a true democratization of one of the most powerful technologies," said Pat Gelsinger, CEO of VMware. "We're also collaborating to define a new architecture for the hybrid cloud-one purpose built to support the needs and demands of the next generation of applications. Together, we're positioned to help every enterprise accelerate their use of breakthrough applications to drive their business."
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CHDN | Hot Stocks15:10 EDT EPA, DOJ announce settlement with Churchill Downs Louisiana Horseracing - The U.S. Environmental Protection Agency and the Department of Justice have announced a settlement with the Churchill Downs Louisiana Horseracing, d/b/a Fair Grounds that will resolve years of Clean Water Act violations at its New Orleans racetrack. Under the settlement, Fair Grounds will eliminate unauthorized discharges of manure, urine and process wastewater through operational changes and construction projects at an estimated cost of $5,600,000. The company also will pay a civil penalty of $2,790,000, the largest ever paid by a concentrated animal feeding operation in a CWA matter. Fair Grounds was purchased by Churchill Downs in 2004. Reference Link
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ASFI | Hot Stocks14:21 EDT Asta Funding completes take-private transaction, to be delisted - Asta Funding announced that its merger whereby the company has become a wholly-owned subsidiary of Asta Finance Acquisition, Inc. is complete. The transaction was previously announced on April 8, 2020. Under the terms of the merger agreement, Asta's stockholders will receive $13.10 per share in cash. As a result of the closing of the transaction, Asta's common stock has ceased trading as of today on the NASDAQ Global Select Market and will be delisted.
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SKYW | Hot Stocks14:07 EDT SkyWest reports entry into $573M secured loan facility under CARES Act - SkyWest announced that it and its wholly-owned subsidiary SkyWest Airlines, Inc. have entered into a five-year Loan and Guarantee Agreement with the U.S. Treasury Department which provides SkyWest Airlines with a secured term loan facility to borrow up to $573M under the Coronavirus Aid, Relief, and Economic Security Act, or "CARES Act." On September 29, upon entry into the Loan Agreement, SkyWest Airlines borrowed $60M under the facility and has until March 26, 2021 to determine if it will borrow additional amounts in up to two subsequent borrowings. The interest rate under the secured term loan facility is LIBOR plus 3.0% with no amortization. In consideration for the loan, SkyWest is obligated to issue warrants to the U.S. Treasury Department to purchase shares of common stock based on, and in connection with, amounts drawn under the secured term loan facility. In connection with the initial $60M draw under the facility, SkyWest issued warrants to purchase 211,416 shares of common stock at an exercise price of $28.38 per share. The Loan and Guarantee Agreement also includes certain restrictions, including restrictions on the payment of dividends and the repurchase of SkyWest shares. The Secured Loan is collateralized by aircraft engines and aircraft parts.
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DIS | Hot Stocks14:05 EDT Disney working on 'The Lion King' sequel with Barry Jenkins as director - "Moonlight" and "If Beale Street Could Talk" director Barry Jenkins has confirmed reports that he has been named to director a sequel to the 2019 remake of "The Lion King" for Walt Disney Studios. Reference Link
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MGM | Hot Stocks14:05 EDT MGM Resorts announces 'Convene with Confidence' plan for meetings, conventions - MGM Resorts International announced what it has called "a comprehensive plan designed to facilitate the safe return of meetings and conventions at the company's properties in Las Vegas and throughout the United States, subject to local regulations and restrictions." MGM Resorts' "Convene with Confidence" plan "is the result of months of work with experts and builds on the company's Seven-Point Safety Plan to provide a comprehensive approach to health and safety. This includes the option for a multi-layered health screening process using CLEAR's Health Pass and utilizing on-site rapid, molecular COVID-19 testing that can deliver results within approximately 20 minutes," the company stated.
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IFRX | Hot Stocks13:53 EDT Results of study of vilobelimab in patients with severe COVID-19 published - An exploratory, open-label, randomized phase 2 trial, as part of the adaptive phase 2/3 PANAMO trial, of intravenous IFX-1 in adults with severe COVID-19 was conducted at three academic hospitals in the Netherlands, according to a post published by The Lancet. The interpretation section of the post states: "In this small exploratory phase 2 part of the PANAMO trial, C5a inhibition with IFX-1 appears to be safe in patients with severe COVID-19. The secondary outcome results in favour of IFX-1 are preliminary because the study was not powered on these endpoints, but they support the investigation of C5a inhibition with IFX-1 in a phase 3 trial using 28-day mortality as the primary endpoint." Funding for the study came from InflaRx, the post notes. Reference Link
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AMZN | Hot Stocks13:44 EDT Spain's competition regulator CNMC says Amazon 'must comply as postal operator - The CNMC concludes that Amazon performs postal operator work and that it must comply with the regulations of the postal sector. The Fly notes that the Comision Nacional de los Mercados y la Competencia or National Commission on Markets and Competition or CNMC, is Spain's independent competition regulator responsible for enforcing competition law. Reference Link
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SBH | Hot Stocks13:17 EDT Sally Beauty acquires Quebec's La Maison Ami-Co. - Sally Beauty announced the acquisition of La Maison Ami-Co., a professional beauty products distributor in the Canadian province of Quebec, by its subsidiary Beauty Systems Group. The transaction includes the acquisition of 10 La Maison Ami-Co stores, the addition of 17 direct sales consultants and exclusive distribution rights in Quebec to premier professional hair color and hair care brands including Wella Professional, Goldwell and Oribe. "This acquisition will allow BSG to further expand its operations throughout Quebec and will increase BSG's professional beauty product offerings in its existing Chalut store network and full-service business that was acquired in 2017," Sally Beauty said in a statement.
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SBH | Hot Stocks13:10 EDT Sally Beauty acquires Quebec,'s La Maison Ami-Co. - Sally Beauty announced the acquisition of La Maison Ami-Co., a professional beauty products distributor in the Canadian province of Quebec, by its subsidiary Beauty Systems Group. The transaction includes the acquisition of 10 La Maison Ami-Co stores, the addition of 17 direct sales consultants and exclusive distribution rights in Quebec to premier professional hair color and hair care brands including Wella Professional, Goldwell and Oribe. "This acquisition will allow BSG to further expand its operations throughout Quebec and will increase BSG's professional beauty product offerings in its existing Chalut store network and full-service business that was acquired in 2017," Sally Beauty said in a statement.
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FB | Hot Stocks13:04 EDT Facebook testing Accounts Center in Facebook, Instagram, Messenger settings - Facebook said in a blog post that, starting this week, it is testing Accounts Center in settings on Facebook, Instagram and Messenger. "Switching apps to post the same content or entering your credit card information dozens of times is a pain," the company said. "We want to make that easier while giving you better controls to manage your experience. Whether you want to share a story to Instagram and Facebook at the same time, or use your Facebook account to log into Instagram, setting up your Accounts Center will allow you to control connected experiences that work across our apps." Reference Link
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ABT | Hot Stocks12:56 EDT Canada purchases up to 7.9M rapid Covid tests from Abbott - The Government of Canada said it has signed an agreement with Abbott Rapid Diagnostics to purchase up to 7.9M ID NOW rapid point-of-care tests, pending Health Canada authorization of the tests. Under the agreement with Abbott (ABT), the Government of Canada is also purchasing up to 3,800 analyzers, which are the devices that perform the test and deliver the rapid results. Reference Link
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JPM | Hot Stocks12:26 EDT Justice Department confirms $920M deferred prosecution agreement with JPMorgan - he Department of Justice announced that JPMorgan Chase has entered into a resolution to resolve "criminal charges related to two distinct schemes to defraud: the first involving tens of thousands of episodes of unlawful trading in the markets for precious metals futures contracts, and the second involving thousands of episodes of unlawful trading in the markets for U.S. Treasury futures contracts and in the secondary (cash) market for U.S. Treasury notes and bonds." JPMorgan entered into a deferred prosecution agreement in connection with a criminal information filed today in the District of Connecticut charging the company with two counts of wire fraud. Under the terms, JPMorgan will pay over $920M in a criminal monetary penalty, criminal disgorgement, and victim compensation, with the criminal monetary penalty credited against payments made to the Commodity Futures Trading Commission under a separate agreement with the CFTC and with part of the criminal disgorgement credited against payments made to the Securities Exchange Commission under a separate agreement with the SEC. Reference Link
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JPM | Hot Stocks12:17 EDT JPMorgan resolves probes into precious metals, U.S. treasuries markets - JPMorgan Chase announced that the firm has entered into agreements with the U.S. Department of Justice, the U.S. Commodity Futures Trading Commission and the U.S. Securities & Exchange Commission to resolve investigations into historical trading practices by former employees in the precious metals and U.S. treasuries markets, and related conduct between 2008 and 2016. "The conduct of the individuals referenced in today's resolutions is unacceptable and they are no longer with the firm," said Daniel Pinto, co-President of JPMorgan Chase and CEO of the Corporate & Investment Bank. "We appreciate that the considerable resources we've dedicated to internal controls was recognized by the DOJ, including enhancements to compliance policies, surveillance systems and training programs." In connection with the agreements, the firm will pay a total of approximately $920M and has entered into a deferred prosecution agreement with the DOJ. The DPA will expire after three years so long as the firm and its subsidiaries, JPMorgan Chase Bank, N.A. and J.P. Morgan Securities LLC, fully comply with their respective obligations under the DPA. The firm does not expect any disruption of service to clients as a result of these resolutions. Today's agreements fully resolve investigations by the DOJ, CFTC and SEC facing the firm on these matters.
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MKGAY BIIB | Hot Stocks12:11 EDT Merck KGaA reverses EUR 365M provision for lawsuit after ruling in Biogen fight - Merck KGaA (MKGAY) announced: "In the United States, Merck KGaA's subsidiary EMD Serono is involved in a US patent dispute with Biogen (BIIB). Biogen sued Merck for damages in connection with a patent infringement caused by Merck's product Rebif before the U.S. District Court New Jersey, Newark. Merck defended itself against the allegations and brought a countersuit claiming that Biogen's patent is invalid. In February 2018 a jury declared Biogen's patent invalid vis-a-vis Merck. The jury verdict was overturned by the District Court Judge, who upheld the validity of Biogen's patent. Merck filed a complaint with the U.S. Court of Appeals for the Federal Circuit against this ruling. On September 28, 2020, the U.S. Court of Appeals for the Federal Circuit set aside the decision of the District Court Judge, invalidated Biogen's patent and instructed the District Court to reinstate the jury verdict. Therefore, Merck KGaA has decided today to reverse the provisions for the patent dispute proceedings in the amount of EUR 365 million. Thereof, up to a mid to high double-digit million amount might be booked into the financial result. Merck KGaA will adjust its forecasts accordingly as part of its regular financial reporting."
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SQ | Hot Stocks12:05 EDT Square unveils QR-based, self-serve ordering feature for restaurants - Square announced a QR-based self-serve ordering feature for restaurants. Square Online sellers can now limit in-person contact, increase safety, improve order accuracy, and adapt to changing consumer preferences - all helping to ensure that they never miss a sale. Consumers visiting a restaurant simply scan the QR code with their personal device and place the order via the seller's mobile-optimized ordering page. Once the buyer completes their order, it is received at the seller's point of sale and relayed to their kitchen printers just as if the order was inputted directly by a server. Once the order is ready, a food runner looks for the table identifier on the order ticket and brings out the food. Self-serve ordering also enables sellers to collect customer information on sales and foster deeper relationships with buyers through Square Loyalty and Square Marketing. Buyers can collect and redeem loyalty points on purchases made through Square Online just as they would at a Square point-of-sale. Self-serve ordering is available now for Square Online sellers in the US, UK, Canada, and Australia. This is just the latest feature we've built to help sellers continue serving their customers in this challenging new business environment. Every business has different needs, and using Square Online, restaurants can engage with their customers in the way that best suits their business - whether that's via curbside pickup, delivery, or self-serve ordering. Reference Link
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ZS VMW | Hot Stocks12:01 EDT Zscaler, VMware announce extension of strategic partnership - Zscaler (ZS) announced an expanded strategic partnership with VMware (VMW) to help organizations simplify security in the workplace. By more closely aligning the next-generation networking and security capabilities from both companies, Zscaler will work with VMware to help large global enterprises simplify the adoption of a complete Secure Access Service Edge architecture and more effectively implement Zero Trust security, Zscaler said in a statement.
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UNFI | Hot Stocks12:00 EDT United Natural Foods falls -12.1% - United Natural Foods is down -12.1%, or -$2.31 to $16.87.
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MYOV | Hot Stocks12:00 EDT Myovant Sciences falls -21.4% - Myovant Sciences is down -21.4%, or -$4.52 to $16.57.
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JE | Hot Stocks12:00 EDT Just Energy falls -36.7% - Just Energy is down -36.7%, or -$3.52 to $6.08.
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NCR | Hot Stocks12:00 EDT NCR Corp. rises 7.8% - NCR Corp. is up 7.8%, or $1.56 to $21.59.
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BEKE | Hot Stocks12:00 EDT KE Holdings rises 8.2% - KE Holdings is up 8.2%, or $5.03 to $66.42.
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TCS | Hot Stocks12:00 EDT Container Store rises 10.7% - Container Store is up 10.7%, or 66c to $6.83.
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MSFT EA | Hot Stocks11:56 EDT Microsoft says EA Play coming to Xbox Game Pass for console on November 10 - Microsoft (MSFT) said in a blog post that Xbox Game Pass Ultimate subscribers will have access to an EA Play (EA) membership at no additional cost starting November 10. The company noted that members with an Ultimate or PC subscription will be able download EA Play games beginning in December. The Fly notes that the Xbox Series X and Series S, which will both have Game Pass access, are coming out on November 10 as well.
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BTU | Hot Stocks11:24 EDT Court upholds FTC decision to block Peabody, Arch joint venture - Peabody announced that the U.S. District Court concluded its review and is supporting Federal Trade Commission efforts to block the formation of the joint venture combining the companies' Powder River Basin and Colorado assets. "We are deeply disappointed with the court's decision as the intense all-fuels competition is clearly apparent to us," said Peabody President and CEO Glenn Kellow. "Our focus now is on continuing to be the low-cost PRB coal provider to best compete against natural gas and subsidized renewables. We remain committed to ensuring our customers continue to have access to a reliable and affordable fuel source."
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BYD... | Hot Stocks11:23 EDT NFL confirms Titans, VIkings suspend in-person club activities - Publicly traded companies in the gambling space include Boyd Gaming (BYD), Caesars (CZR), Churchill Downs (CHDN), DraftKings (DKNG), Flutter Entertainment (PDYPY), Gan Limited (GAN), Las Vegas Sands (LVS), MGM Resorts (MGM), Penn National (PENN), William Hill (WIMHY) and Wynn Resorts (WYNN).
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MGM... | Hot Stocks11:23 EDT Titans, Vikings halt in-person work amid multiple positive COVID tests - In a statement, NFL said that, "On Tuesday morning, the Titans COVID testing results returned three new player positives and five new personnel positives. The Titans will suspend in-person club activities starting today. Likewise, the Vikings, who played the Titans on Sunday, will also suspend in-person club activities. Both clubs are working closely with the NFL and the NFLPA, including our infectious disease experts, to evaluate close contacts, perform additional testing and monitor developments. All decisions will be made with health and safety as our primary consideration. We will continue to share updates as more information becomes available." Publicly traded companies in the sports betting space include Boyd Gaming (BYD), Caesars (CZR), Churchill Downs (CHDN), DraftKings (DKNG), Flutter Entertainment (PDYPY), Gan Limited (GAN), Las Vegas Sands (LVS), MGM Resorts (MGM), Penn National (PENN), William Hill (WIMHY) and Wynn Resorts (WYNN). Reference Link
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DMRC | Hot Stocks11:12 EDT TCM Strategic to buy $53.5M of Digimarc common, convertible preferred equity - TCM Strategic announced today it has agreed to acquire $53.5M of common and convertible preferred equity in Digimarc Corporation. TCM Strategic's decision to make this investment was the result of two conclusions: The Legacy Business and the Growth Business are each worth more today than the current enterprise value of the entire company. The Growth Business has not only the opportunity but also the high likelihood of being worth significantly more in the future. "This financing provides Digimarc with enough capital to ensure the continued acceleration of growth in the Barcode business. Furthermore, it should be sufficient to fund the company through profitability, even assuming the most conservative macro and micro scenarios. Therefore, we believe that the next time Digimarc accesses the equity market, it will be to reduce - rather than increase - shares outstanding."
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NBEV | Hot Stocks10:55 EDT Zachert Private Equity acquires Brands Within Reach from NewAge for $15M - Zachert Private Equity has acquired Brands Within Reach including its owned retail brands and various licensing and distribution rights from NewAge in a deal valued at $15M. The divested operations include BWR's owned brands which are Xing, bucha, Aspen Pure and CoCo Libre and other assets and licensed brands such as Nestea, Volvic, evian, Illy, Kusmi Tea, Saint Geron, Grand Mere, Lucien and Found; and the machinery, equipment and other assets necessary for the distribution of these brands.
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CFMS | Hot Stocks10:47 EDT Conformis announces 510(k) clearance for Cordera Hip System - Conformis announced 510(k) clearance by the U.S. Food and Drug Administration of the company's new Cordera Hip System. The first product in the Conformis hip product line, the Conformis Hip System, was launched commercially in November 2019 and provided a patient-specific stem, the company said. "Our new Cordera(TM) Hip System is the first expansion of our growing total hip portfolio. The system, which is inserted using an anterior or posterior surgical approach, will allow surgeons to treat a wider range of patients effectively. And surgeons have the option to select an accompanying personalized surgical plan and best in class PSI guides provided through a safe, sterile, and efficient model for hospitals and ambulatory surgery center sites of care," added Mark Augusti, President and CEO of Conformis.
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SUI | Hot Stocks10:24 EDT Safe Harbor Marinas enters merger agreement with Sun Communities for $2.11B - Safe Harbor Marinas announces it has entered into a definitive merger agreement with Sun Communities and one of its subsidiaries in a transaction for cash and SUI equity valued at $2.11B. The transaction is expected to close during the fourth quarter and is subject to customary closing conditions. Safe Harbor Marinas was built in partnership with American Infrastructure Funds, Koch Real Estate Investments, Weatherford Capital, and Guggenheim Partners.
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CTXR | Hot Stocks10:19 EDT Citius: DMC recommends continuing Mino-Look trial without modifications - Citius Pharmaceuticals announced that a Data Monitoring Committee meeting was held to review the data being generated and analyzed in the Mino-Lok phase 3 trial, and to make recommendations to Citius as to any action that may be necessary regarding the study. After reviewing these data, the DMC members stated that they did not find any safety signals; and they also recommended continuing the trial without any modifications. The DMC further requested to have an ad hoc meeting in the near future. The Data Monitoring committee is an independent panel of experts that review progress regarding the safety and efficacy of drugs in clinical trials, and to determine if the trial may be futile in achieving its endpoints or if the trial should be modified in any way. "We are very pleased with the outcome of the DMC's independent review of the Mino-Lok data. This information is very encouraging and supports the confidence that we have long held in the safety and efficacy of Mino-Lok," said Myron Holubiak, CEO of Citius. "Despite challenges in recruiting patients recently due to the COVID-19 pandemic, we have continued to recruit patients and are now approaching the late stage of our pivotal study." Holubiak continued, "I want to thank the DMC committee members for their thoughtful review, and also all of the study investigators and their staff that continue to support our trial in these challenging times."
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JPM | Hot Stocks10:19 EDT CFTC commissioner supports $920M penalty against JPMorgan - Commodity Futures Trading Commission Commissioner Dan Berkovitz announces support for the Commission action ordering JPMorgan to pay $920M for "manipulating" the precious metals and U.S. Treasury futures markets. "However, I oppose the CFTC's determination that JPMorgan's conduct should not result in any disqualifications under the 'bad actor' provisions of the securities laws, for the reasons outlined below," Berkovitz added in a statement. He went on, "For eight years, a group of traders at JPMorgan systematically "spoofed" precious metals and Treasury futures markets by entering hundreds of thousands of orders with the intent to cancel them before execution. The Commission's Order finds that JPMorgan manipulated these markets and failed to diligently supervise its traders. The scope of misconduct and market harm described in the Order is unparalleled among prior spoofing cases brought by the Commission. This enforcement action illustrates how vital it is for firms to maintain adequate surveillance systems and promptly investigate red flags." Reference Link
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INTC | Hot Stocks10:08 EDT Intel enters into strategic collaboration with Lightbits Labs - Intel and Lightbits Labs have announced an agreement "to propel development of disaggregated storage solutions to solve the challenges of today's data center operators who are craving improved total-cost-of-ownership due to stranded disk capacity and performance.," the companies said. This strategic partnership includes technical co-engineering, go-to-market collaboration and an Intel Capital investment in Lightbits Labs. Lightbits' LightOS will be fully optimized for Intel hardware. According to the companies, "Lightbits Labs will enhance its composable disaggregated software-defined storage solution, LightOS, for Intel technologies, creating an optimized software and hardware solution. The system will utilize Intel Optane persistent memory and Intel 3D NAND SSDs based on Intel QLC Technology, Intel Xeon Scalable processors with unique built-in artificial intelligence acceleration capabilities and Intel Ethernet 800 Series Network Adapters with Application Device Queues technology. Intel's leadership FPGAs for next-generation performance, flexibility and programmability will complement the solution." Reference Link
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JWN | Hot Stocks10:03 EDT Nordstrom to stop selling products made using fur, exotic animal skins - Nordstrom announcedthe company willstopsellingproducts made using animal fur or exotic animal skin by the end of 2021. The new companywide policy includes Nordstrom, Nordstrom Rack and Last Chance stores, as well asNordstrom's e-commerce sites. The commitment was made in partnership with the Humane Society of the United States.
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PCTY | Hot Stocks10:02 EDT Paylocity appoints Tauhidah Shakir as chief diversity officer - Paylocity announced the appointment of Tauhidah Shakir as Vice President of Human Resources, Chief Diversity Officer. The company also announced its renewed commitment to diversity, equity and inclusion policies and programs that are focused on education & awareness, conscious products, company representation, advocacy & support, fairness & equity and community action. Shakir brings more than 20 years of experience in providing strategic HR support, developing DEI programs and coaching leaders.
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HUM | Hot Stocks10:02 EDT Humana, Rush Health sign Medicare network agreement - Rush Health and Humana announced an agreement to expand access to quality, in-network medical care in the Chicago area for Humana Medicare Advantage members. The agreement provides in-network access for Humana Medicare Advantage Health Maintenance Organization, Preferred Provider Organization, and Private Fee-for-Service health plan members at Rush Health, which is comprised of its flagship Rush University Medical Center in Chicago, as well as three suburban hospitals: Rush Copley Medical Center, and Rush Oak Park Hospital, and Riverside Medical Center. The contract also offers in-network access for Humana Medicare Advantage members seeking care from Rush Health's clinically integrated network of more than 1,800 providers, which includes both physicians and non-physician clinicians. Furthermore, the agreement includes a value-based care agreement with the providers in order to improve health outcomes and the patient experience.
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UNFI | Hot Stocks10:00 EDT United Natural Foods falls -12.5% - United Natural Foods is down -12.5%, or -$2.41 to $16.77.
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MYOV | Hot Stocks10:00 EDT Myovant Sciences falls -23.5% - Myovant Sciences is down -23.5%, or -$4.95 to $16.14.
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JE | Hot Stocks10:00 EDT Just Energy falls -26.5% - Just Energy is down -26.5%, or -$2.54 to $7.06.
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OAC | Hot Stocks10:00 EDT Oaktree Acquisition rises 8.2% - Oaktree Acquisition is up 8.2%, or 93c to $12.18.
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ASC | Hot Stocks10:00 EDT Ardmore Shipping rises 9.0% - Ardmore Shipping is up 9.0%, or 27c to $3.28.
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GPMT | Hot Stocks10:00 EDT Granite Point Mortgage rises 11.3% - Granite Point Mortgage is up 11.3%, or 78c to $7.64.
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APDN | Hot Stocks09:47 EDT Applied DNA signs master services agreement with Stony Brook University Hospital - Applied DNA Sciences announced the signing of a Master Services Agreement with Stony Brook University Hospital. Under the terms of the one-year MSA, Applied DNA will supply its EUA authorized LineaTM COVID-19 Assay Kit to SBUH on an as-needed basis. Concurrently, the Company announced the receipt of an initial purchase order under the MSA. Terms of the MSA and initial purchase order were not disclosed. Under the MSA, the Company designed and implemented an automated, high-throughput COVID-19 testing workflow in the SBUH clinical lab. The implemented high-throughput testing workflow is a fully integrated offering that includes equipment, software, and services leased through the Company, including robotic RNA extraction, robotic sample preparation, and RT-PCR custom software and interfaces with laboratory information systems. The testing workflow offers the SBUH clinical lab enhanced operational flexibility and an enhanced testing capacity with the Assay Kit. The Company is willing to offer similar equipment arrangements to other diagnostic labs looking for high sensitivity, high throughput testing solutions for COVID-19.
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VUZI | Hot Stocks09:46 EDT Vuzix receives international approvals, begins shipping Vuzix Blade glasses - Vuzix announced that the company has received regulatory approvals for the Blade Upgraded Smart Glasses from the US and Canada, EU and Japanese regulatory agencies. Concurrently, Vuzix has begun shipping early Blade Upgraded Smart Glasses orders, as well as making the Blade Upgraded Smart Glasses available for purchase from Vuzix' directly and shortly available from Amazon online stores in the US, Canada and Japan, the company said in a statement. "With its integrated in-frame stereo audio featuring patent pending technology, alongside the improved auto focus camera, the Vuzix Blade Upgraded version opens up significant doors across enterprise and prosumers for Vuzix," said Paul Travers, President and CEO at Vuzix.
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NOVA | Hot Stocks09:41 EDT Sunnova falls after Spruce Point issues short report with $5-$8 target - Shares of Sunnova Energy are moving lower after Spruce Point Capital Management issued a short report on the company predicting up to 88% downside in the shares. Sunnova is a "specialty finance company with undifferentiated offerings that operates in a competitive industry facing secular headwinds," Spruce Point said in a report posted on its website. Management "masks its poor and unsustainable economics with potentially misleading and assumption-based non-GAAP metrics and aggressive accounting," the firm known for short selling added. Spruce Point put a price target of $5 to $8 on the shares. Sunnova Energy in early trading is down 7.5%, or $2.00, to $24.74.
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OPTN | Hot Stocks09:36 EDT Optinose announces peer-review publication on XHANCE data - Optinose announced the peer-review publication of a paper titled, "Efficacy of the exhalation delivery system with fluticasone in patients who remain symptomatic on standard nasal steroid sprays"1 in the International Forum of Allergy & Rhinology, the journal of the American Rhinologic Society. EDS-FLU is U.S. Food and Drug Administration approved for the treatment of nasal polyps in patients 18 years of age or older and is marketed under the trade name XHANCE for the up to 1 in 3 patients whose chronic rhinosinusitis is complicated by nasal polyps. First-line treatment for the 10 million patients who suffer with nasal polyps is often conventional, over the counter, inhaled steroids that were originally approved for allergic rhinitis. But unlike AR, the nasal polyps associated with chronic rhinosinusitis start deep in the nasal cavity where nasal sprays usually do not reach. This analysis of data from the Phase 3 XHANCE studies showed comparable improvement across multiple outcome measures for patients receiving XHANCE, regardless of whether they were previously treated with a conventional inhaled nasal spray.
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NOVA | Hot Stocks09:35 EDT Spruce Point issues Strong Sell opinion on Sunnova Energy - Spruce Point Capital Management, a New York-based investment management firm that focuses on forensic research and short-selling, issued a 91-page report entitled "Is There Really Something New Under The Sun?" that outlines why shares of Sunnova Energy International face up to 80% downside risk. Based on extensive forensic analysis and a holistic review of Sunnova's accounting practices, financial controls and reporting, and corporate governance, Spruce Point has reached a clear conclusion: although the company markets itself as a solar energy business, the reality is that Sunnova is a highly over-valued specialty finance business that lacks differentiated offerings and operates in a very competitive industry facing significant secular headwinds. "Notably, our research reveals that CEO William Berger's biography curiously omits his previous role at Enron Corporation, which was the early 2000s Wall Street darling known for its aggressive accounting and financial reporting, which ultimately led to a historic bankruptcy and fraud charges against the CFO. Additionally, we uncovered that Sunnova's CFO Robert Lane obscured his tenure at Madison Williams in public filings, a bankrupt energy broker-dealer backed by two dubious investors. A bankruptcy trustee later referred to one of Madison Williams' investors as having, "...many of the characteristics of a Ponzi scheme." Spruce Point finds it incredibly worrisome that under Mr. Berger and Mr. Lane, Sunnova's non-GAAP metrics employ highly aggressive and non-standard industry assumptions that we believe are similar to financial interpretations used by Enron. Shareholders should be particularly alarmed that Mr. Berger and Mr. Lane have attempted to conceal their connections to failed enterprises. We contend that such affiliations are highly germane to any investor's due diligence and assessment of Sunnova." Spruce Point believes that Sunnova faces up to 80% downside risk once the market evaluates the Company for what it truly is: a specialty finance business that has been benefiting from investor euphoria for solar energy stocks.
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DMRC | Hot Stocks09:31 EDT TCM Strategic Partners invests $53.5M in Digimarc - Digimarc announced a $53.5M investment from TCM Strategic Partners led by long time shareholder Riley McCormack. TCM purchased approximately 2.5M shares of common stock, representing 19.9% of the company's outstanding common stock, with the balance of the investment to be made through the purchase of convertible preferred shares, subject to the satisfaction of customary closing conditions. The convertible preferred shares will convert automatically following shareholder approval required under Nasdaq Listing Rules 5635(b) and 5635(d).
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SUI | Hot Stocks09:29 EDT Sun Communities to acquire Safe Harbor Marinas for $2.1B - Sun Communities announced that it has entered into a definitive merger agreement to acquire Safe Harbor Marinas. Safe Harbor's full operating team, led by Baxter Underwood, will run Safe Harbor as a subsidiary of the Company independently from Sun's manufactured home and recreational vehicle community business. Safe Harbor is the largest and most diversified marina owner and operator in the United States. It owns and operates 101 marinas, manages five marinas on behalf of third parties and has an approximate 40,000-member network of boat owners across 22 states. Safe Harbor's portfolio of high quality, prime coastal market marinas generates recurring rental income from annual and seasonal leases and further diversifies Sun's geographic and demographic footprint. Safe Harbor has a proven ability to generate organic and external growth. The acquisition, which is expected to be accretive to 2021 Core FFO per share, will comprise approximately 15% of the Company's pro forma total annual rental revenue. Subject to closing adjustments, the aggregate purchase price for Safe Harbor is approximately $2.11B. At the closing, the Company will assume debt in the estimated amount of approximately $808M, issue the sellers REIT operating partnership common and preferred OP units in the estimated amount of approximately $130M, and pay the balance of the purchase price in cash. The mix of consideration will depend on the amount of common and preferred OP units the sellers elect to receive and other factors. The actual amounts of each component of the merger consideration may be materially higher or lower than the foregoing estimates. The transaction is subject to customary closing conditions and is expected to close in the fourth quarter 2020.
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AGYS | Hot Stocks09:21 EDT Caesars Entertainment UK selects Agilysys IG OnDemand - Agilysys announced that Caesars Entertainment - UK has expanded its existing relationship with Agilysys with the addition of its innovative new contactless food and beverage ordering solution, IG OnDemand, across its properties. A longtime user of Agilysys' award-winning InfoGenesis POS, Caesars looked to Agilysys again to solve their touchless guest food & beverage ordering challenges while encouraging social distancing. IG OnDemand is helping Caesars to provide contactless self-service at 7 of their UK based casinos for their main bars and gaming floors, while providing an exceptional guest experience. "When we looked for a way to extend our existing InfoGenesis POS with contactless guest self-service, Agilysys IG OnDemand was ready," said Caesars-UK Food and Beverage Director, Rob Wear. "IG OnDemand is helping us enhance our service while encouraging social distancing to help keep guests and staff safe as well as optimising operations and increasing F&B revenue."
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INDXF | Hot Stocks09:16 EDT Indus Holdings launches lineup of Moon Edibles - Indus Holdings is expanding its lineup of best-selling MOON edibles with all-new MOON gummies and mints, while announcing the return of two out-of-this-world seasonal flavors - back by popular demand. Announcing two new additions to our lineup; All New Moon Gummies: Our new 5mg THC MOON gummies are sold in tin packs of 20. The debut flavor lineup includes: Tropical Sunrise, a sativa blend of bright mango and juicy pineapple flavors; Fruit Punch, a hybrid mix featuring the taste of wild strawberries, red raspberries, and citrus; and Blueberry Lemonade, an indica blend of sweet and sour - perfect for the after-work unwind. All New Moon Mints: Each one of these new mints contain 2.5mg THC and is sold in servings of 40. As with our MOON gummies, the mints are created using all-natural ingredients without a hint of cannabis taste. And, the refined return of two seasonal favorites; The Pumpkin Spice Orbit Bar: A terpene-enriched hybrid edible chocolate bar - a uniquely crafted blend of 10mg THC, Guittard chocolate, and Amoretti flavoring - is back just in time for fall. The Peppermint Parallax Bar: a classic 10mg THC, the terpene-enriched, hybrid dark chocolate will return to retailers in early November just in time to fill stockings abound with holiday cheer.
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EFOI | Hot Stocks09:15 EDT Energy Focus appoints James Warren as general counsel, corporate secretary - Energy Focus appointed James Warren as its Senior Vice President, General Counsel and Corporate Secretary. Mr. Warren's responsibilities include corporate governance, securities, intellectual property, and commercial transactions, as well as corporate strategic development. Mr. Warren previously served as a corporate lawyer at GrafTech International Ltd., a global manufacturer of graphite electrodes for electric arc furnace steel production.
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NWVCF | Hot Stocks09:14 EDT EnWave signs equipment purchase agreement with Intakt Snacks - EnWave announced that it has signed an Equipment Purchase Agreement with Lake Blue SpA d.b.a. INTAKT SNACKS. Intakt Snacks has purchased a second 10kW Radiant Energy Vacuum machine to double its royalty-bearing capacity for the commercial production of dried cheese snacks in Chile. Intakt Snacks previously signed a royalty-bearing commercial license with EnWave in July 2015 and pays the Company a royalty equal to five percent of the revenues it generates from REV-dried products. Intakt Snacks' portfolio of crunchy cheese products includes different types of cheese infused with various natural ingredients like Chili Pepper and Coriander, Black Pepper, Oregano, Mozzarella-Blue Cheese, Onion, Tomato-Basil-Oregano, Blueberry, Raspberry, and Honey. Intakt Snacks currently distributed its products through domestic retailers in Chile and the U.S. through several keto snack distribution companies and e-commerce platforms. Intakt Snacks plans to expand its distribution into the Chinese and the Japanese markets in 2021, and recent growth has led to the need for additional REV machine capacity. EnWave currently has forty active royalty-partners, including twelve companies that are using REV technology to create innovative, nutritious, shelf-stable dairy applications. REV offers its users proven scalability, reliability and material economic advantages.
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BYND WMT | Hot Stocks09:13 EDT Beyond Meat shares jump after Walmart triples Beyond Burger locations - Shares of Beyond Meat are moving higher after the company announced an expansion in its relationship with Walmart (WMT). Walmart plans to triple availability of the Beyond Burger from approximately 800 locations to more than 2,400 stores nationwide beginning next week, Beyond Meat said in a statement. Beyond Meat first launched its frozen products at Walmart in 2015. Since then, Walmart has expanded its Beyond Meat in-store offerings to include the Beyond Burger and Beyond Sausage in the fresh meat aisle and most recently, the Beyond Breakfast Sausage patties in the freezer aisle, the company noted. Shares of Beyond Meat are up 7%, or $10.20, to $161.50 in premarket trading.
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TRUE AUDVF | Hot Stocks09:12 EDT TrueCar partners with Audi to provide military shoppers preferred pricing - TrueCar (TRUE) has teamed up with luxury automaker Audi (AUDVF) to provide preferred pricing and exclusive incentives to verified TrueCar Military car shoppers on new Audi cars and SUVs. The TrueCar Military Auto Member Offer is available from now until January 4, 2021 through TrueCar Military. Verified TrueCar Military members can receive a $750 - $1,000 additional incentive on select new 2020 & 2021 models. This offer is valid at any Audi dealership nationwide.
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SLAB | Hot Stocks09:12 EDT Silicon Labs promotes Serena Townsend to vice president and Chief People Officer - Silicon Labs announced Serena Townsend, formerly vice president of Human Resources, has been promoted to senior vice president and Chief People Officer. Townsend's promotion is effective immediately and includes responsibility for the company's global talent strategy, people programs, and values-driven, inclusive culture. Lori Knowlton, previously senior vice president and Chief People Officer, is leaving Silicon Labs to focus on family and pursue other interests. Townsend joined Silicon Labs in February 2017 as director, HR business partners. She was promoted to vice president, HR business partners in March 2020. Before joining Silicon Labs, Townsend held various HR leadership positions at companies including Samsung Austin Semiconductor and HomeAway. She holds a Bachelor of Arts from The University of Texas, is a UT distinguished college scholar, and volunteers for organizations including Crossing Thresholds and Make-A-Wish Central & South Texas.
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ACHC | Hot Stocks09:11 EDT Acadia to 'shortly relaunch the formal process' regarding sale of U.K. business - Acadia Healthcare provides an update on the sale process for the U.K. business. The Company previously suspended the sale process due to the market dynamics related to the COVID-19 pandemic. Debbie Osteen, Chief Executive Officer of Acadia Healthcare, remarked, "We have notified potential buyers that we will shortly relaunch the formal process regarding the sale of our U.K. business. Our objective continues to be maximizing value for our stockholders. As we continue to work with our financial and legal advisors, we will update the market on the sales process when and as we determine it is appropriate."
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VZ | Hot Stocks09:10 EDT Verizon expands 5G home internet to Minneapolis & St. Paul customers - Beginning October 1, Verizon will launch 5G Home Internet in Minneapolis & St. Paul, bringing the blazing fast 5G Home Internet service to customers in eight cities, along with newly designed hardware including easy self-setup using augmented reality. It's an ideal broadband service for those who are working or schooling from home, binge-watching content or powering a smart home
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ZM LUMN | Hot Stocks09:09 EDT Zoom Video, Lumen partner to deliver collaboration experience - Zoom Video Communications (ZM) and Lumen Technologies, Inc. (LUMN) announced that the companies will partner allowing Lumen to offer Zoom as part of its Unified Communications and Collaboration Suite. Lumen will deliver enhanced services around Zoom's best-in-class video-first unified communications platform to their large and growing base of customers across the globe. Zoom and Lumen will partner to provide enhanced delivery, customer success, and managed services to companies using Zoom, to deliver an outstanding enterprise experience throughout the customer lifecycle. Additionally, the Lumen network will allow it to deliver an enhanced quality experience, as well as combining its embedded network security with Zoom's built-in security features to proactively protect customers using the combined services.
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BYND WMT | Hot Stocks09:08 EDT Beyond Meat to expand Walmart distribution - Beyond Meat (BYND) announced a major expansion in its long-standing relationship with Walmart (WMT). Following this summer's successful launch of the Cookout Classic value pack, Beyond Meat's most affordable product offering to date, this fall, Walmart plans to triple availability of the Beyond Burger from approximately 800 locations to more than 2,400 stores nationwide beginning next week. The move comes as part of Beyond Meat's effort to increase worldwide accessibility to simple, plant-based meat products made without GMOs.
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VST | Hot Stocks09:08 EDT Vistra Energy raises FY2020 EBITDA view to $3.485B-$3.685B from $3.285B-$3.585B - Vistra provided certain financial updates, including raising and narrowing its 2020 financial guidance, initiating its 2021 financial guidance, and announcing its long-term capital allocation plan. Specifically, Vistra raised and narrowed its 2020 financial guidance for ongoing Ops. Adjusted EBITDA from $3.285B-$3.585B to $3.485B-$3.685B and Ongoing Ops. Adj. FCFbG from $2.160B-$2.460B to $2.375B-$2.575B. FCF Conversion~67%~69%. Sees FY21 Ongoing Ops. Adj. EBITDA $3.075B-$3.475B and Ongoing Ops. Adj. FCFbG $1.765B-$2.165B and FCF Conversion ~60%. The company announced its long-term capital allocation plan: 2021/2022 debt Reduction~$550 and Share Repurchases Up to $1.500B.
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SMAR | Hot Stocks09:07 EDT Smartsheet Gov gets PA by DISA at impact level 4 - Smartsheet announced that Smartsheet Gov has been granted Provisional Authorization, PA by the Defense Information Systems Agency, DISA, at Impact Level, IL 4. The DISA Cloud Provisional Authorization process allows the Department of Defense to authorize cloud service offerings that meet certain security requirements mandated by the level of the information the offering will support. Smartsheet Gov's DISA IL-4 authorization verifies the platform has demonstrated compliance with the Federal Risk and Authorization Management Program,nFedRAMP, and meets the US DoD's strict security requirements. "Leveraging cloud technologies more extensively is a key initiative for the Department of Defense. Legacy technologies not only come with security risks and rising costs, but can impede the mission-critical work of defending our country," said Mark Mader, CEO of Smartsheet. "This authorization meets the demand we're seeing for Smartsheet from DoD agencies and workers, and gives them the ability to modernize workflows, improve transparency, and collaborate with increased effectiveness while knowing the information they share is secure and protected."
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TTEK | Hot Stocks09:07 EDT Tetra Tech acquires BlueWater Federal Solutions, terms undisclosed - Tetra Tech announced that it has further expanded its advanced analytics business with the addition of BlueWater Federal Solutions, an information technology systems and services firm. Based in Chantilly, Virginia, BlueWater has built a team of more than 350 employees who bring expertise in cybersecurity, mission-critical systems design, and development and operation of federal enterprise systems for U.S. government clients, including the Federal Emergency Management Agency, Department of Energy, and Department of Defense. The terms of the acquisition were not disclosed. BlueWater is joining Tetra Tech's government services group.
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DDAIF KNX | Hot Stocks09:05 EDT Knight-Swift aims to reduce carbon emissions by 50% by 2035 - Knight-Swift (KNX) announced that the company has set a goal to reduce its carbon emissions in half by the year 2035. The company anticipates meeting this goal through various initiatives, including: implementing next generation tractor and trailer aerodynamic solutions; continuing deployment of advanced idle reduction technologies; utilizing next generation clean diesel engines; operating Zero-Emissions vehicles, including battery electric and hydrogen fuel cell technology and executing various other strategies as technology is developed and introduced to the market. To formally kickoff this initiative, Knight-Swift has teamed with Daimler (DDAIF)Trucks North America, or DTNA, to deploy the company's first zero-emissions battery electric vehicle, consisting of a pre-production freightliner eCascadia day cab tractor as part of DTNA's freightliner customer experience fleet. This freightliner eCascadia, equipped with a fully electric drivetrain, will be used by Knight-Swift to service the Greater Los Angeles area with the benefit of zero tailpipe emissions.
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HON | Hot Stocks09:05 EDT Honeywell, Carolina Panthers collaborate to offer PPE to fans, staff - Honeywell announced that it is supporting the NFL's Carolina Panthers to help protect players, fans and staff this season. The Panthers and Honeywell are collaborating to create a safer stadium experience by offering individual personal protective equipment packs for Panthers fans and staff, as well as deploying air quality monitoring solutions, via a custom real-time Healthy Buildings dashboard.
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OXFD | Hot Stocks09:05 EDT Oxford Immunotec announces FDA clearance of the T-SPOT.TB test - Oxford Immunotec Global announced that it has received clearance from the FDA to amend the pediatric age limitation to allow use of the T-SPOT.TB test in individuals two years of age and older.
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FBRX | Hot Stocks09:04 EDT Forte Biosciences announces first patient dosing in atopic dermatitis trial - Forte Biosciences announced that the first patient has been dosed in the clinical trial of FB-401 for the treatment of atopic dermatitis. The multi-center, placebo controlled clinical trial of FB-401 is expected to enroll approximately 124 pediatric, adolescent and adult subjects aged 2 years of age and older with atopic dermatitis,AD. The primary endpoint of the trial is EASI-50, which is a measure of the proportion of patients that achieve at least a 50% improvement in the atopic dermatitis disease burden as measured by the Eczema Area and Severity Index, EASI. FB-401 is a topically applied live biotherapeutic consisting of specifically selected strains of commensal Roseomonas mucosa and has demonstrated excellent tolerability and significant improvement in atopic dermatitis disease activity in both adults and children in a Phase 1/2a trial which was recently published in Science Translational Medicine. "We are very excited to be initiating this clinical study," said Paul Wagner, Ph.D., Chief Executive Officer of Forte Biosciences. "FB-401 has the potential to address a significant unmet need for pediatric and adult patients suffering from atopic dermatitis. Children, in particular have limited treatment options and account for the majority of the approximately 17 million AD patients in the U.S. alone." For additional information about the trial, see ClinicalTrials.gov using identifier NCT04504279.
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CLNY | Hot Stocks09:03 EDT DataBank to acquire zColo Data Center assets - DataBank announced that it has signed definitive agreements to acquire zColo, including certain U.S. and European data center assets, from Zayo Group Holdings. The zColo acquisition brings to DataBank an additional 44 data centers including 13 key interconnect locations across 23 markets in the U.S. and Europe. The transaction creates one of the largest privately held data center operators in the U.S. and positions DataBank as a leading provider of edge colocation and connectivity solutions to hyperscale, technology and content customers across the U.S. The transaction is being funded by an investor group led by Colony Capital, DataBank's controlling shareholder, which includes Nuveen Real Estate and others. In addition to leading a consortium of world-class institutional investors to support the acquisition, Colony Capital is investing $145M from its balance sheet to maintain its 20% stake in DataBank. Debt financing associated with the transaction has been underwritten by TD Securities, Truist Securities and Societe Generale, acting as Joint Lead Arrangers and Joint Bookrunners for the new Credit Facility. The closing of the deal is subject to customary conditions and regulatory approvals. The transaction is anticipated to close by year-end 2020.
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EXPE FIVE | Hot Stocks09:03 EDT Five Below appoints Scott Washington to board of directors - Five Below (FIVE) announced that Zuhairah Scott Washington has been appointed an independent member of its Board of Directors, effective today. Ms. Washington becomes the third female member of nine non-employee directors. She is currently the SVP and Global Head of Strategic Partners, Lodging and Vacation Rentals at Expedia Group (EXPE).
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GCI | Hot Stocks09:02 EDT Gannett selects Uberall as global-local presence management solution - Uberall has been selected by Gannett Co., Inc. and its digital marketing subsidiary ReachLocal to become their premier provider of presence management solutions. Gannett is the largest media publisher in the U.S., operating more than 250 local media brands, USA TODAY and Newsquest in the U.K., and digital marketing services companies serving clients around the world. As part of the agreement, Uberall will acquire Gannett's SweetIQ subsidiary. Providing an array of local digital marketing services, the SweetIQ team will join Uberall and become part of a new Montreal hub, the company's seventh location outside its Berlin headquarters.
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SOLY | Hot Stocks09:00 EDT Soliton selects Lippe Taylor to advance commercialization of RAP device - Soliton announced that it has appointed Lippe Taylor Group as its consumer health public relations and customer engagement agency. The partnership aims to support the launch of the Rapid Acoustic Pulse, or RAP, device through connected experiences within aesthetic practices and across digital channels. Soliton's selection of Lippe Taylor Group is "another step in advancing the U.S. commercialization of the Rapid Acoustic Pulse device in the first half of 2021".
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AUVI | Hot Stocks08:57 EDT Applied UV subsidiary files patent application for pathogen-neutralizing system - Applied UV announced that its subsidiary, SteriLumen, has filed a patent application with the U.S. Patent and Trademark Office, or USPTO, pertaining to a system to neutralize pathogens on physical surfaces.
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NAOV | Hot Stocks08:53 EDT NanoVibronix files patent for a transdermal patch - NanoVibronix announces its recent filing of a U.S. patent application entitled "A Transdermal Patch of a Portable Ultrasound-Generating System for Improved Delivery of Therapeutic Agents and Associated Methods of Treatment." According to the application, the transdermal patches are strategically infused with one or more cannabidiol, or CBD, or other pharmaceutical composition and incorporate the company's proprietary low-profile transducer to concomitantly deliver ultrasound energy generated by the PainShield device. The application also covers methods of topically delivering cannabinoids, specifically CBD, for treatment or alleviation of chronic and acute pain.
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TAP KO | Hot Stocks08:50 EDT Molson Coors, Coca-Cola enter agreement to bring Topo Chico Hard Seltzer to U.S. - Molson Coors (TAP) has entered into an exclusive agreement with Coca-Cola (KO) to manufacture, market and distribute Topo Chico Hard Seltzer in the U.S., in an effort to grow the company's above premium portfolio and become a competitor in the hard seltzer segment. Topo Chico Hard Seltzer blends purified sparkling water, a gluten-free alcohol base and natural flavors, with minerals added for taste, and is inspired by Topo Chico sparkling mineral water. Topo Chico Hard Seltzer will be developed in four flavors including: Tangy Lemon Lime, Exotic Pineapple, Strawberry Guava and Tropical Mango, available in 4 flavor, 12-pack variety pack. Molson Coors will use its marketing, sales and distribution for a scaled national launch in the first half of 2021, prioritizing markets where Topo Chico sparkling mineral water is known. The production and packaging of the products will be initially handled by a third party.
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AYRO | Hot Stocks08:49 EDT AYRO, Karma Automotive's Innovation and Customization Center enter partnership - AYRO and Karma Automotive's Innovation and Customization Center announced the formation of a strategic manufacturing, engineering and design partnership. This partnership will utilize Karma's state-of-the-art Innovation and Customization Center, Karma Engineering resources and the Karma Design Studio to provide expertise and contract manufacturing services for the next generation of AYRO's light-duty vehicles. KICC will also provide strategic engineering and development services for electrified solutions within the fast-growing delivery and microdistribution markets. By combining AYRO's end-user, market and engineering expertise with KICC's manufacturing capabilities, development experience and global supply chain capabilities, the companies aim to be able to deliver over 20,000 light-duty trucks and electric delivery vehicles over the next three years, valued at more than $300M. The partnership will initially serve customers in North America, but the supply chain capabilities and resources of the two companies can be leveraged to meet demand across global markets in the future. Dedicated inventory space and assembly lines have been planned for AYRO's EVs within KICC's ISO-certified, 550,000 sq. ft. factory in Moreno Valley, CA. KICC's vertically integrated development capabilities, including frame/chassis build, fabrication center, body shop, robotic paint shop and powertrain integration, should allow the partnership to rapidly respond to customer and market demands for unique, task-oriented configurations and build-outs.
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SGLB | Hot Stocks08:48 EDT Sigma Labs awarded contract by 'major' oil and gas services company - Sigma Labs has been awarded a contract for an initial system by a leading global energy technology provider, to begin production deployment of PrintRite3D in-process quality assurance software, following a successful Rapid Test and Evaluation, RTE, program. The extensive evaluation process involved running PrintRite3D on an EOS single laser machine and a SLM dual laser machine. The customer's engineers worked in collaboration with Sigma's engineering team to address issues specific to their application of the PrintRite3D technology.
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OSTK | Hot Stocks08:47 EDT Overstock.com to celebrate Customer Day on October 4 - On October 4, Overstock.com launches its biggest sale of the year, offering customers 36 hours of massive markdowns on more than one million top-rated products. With an ongoing commitment to quality and value, Customer Day celebrates Overstock shoppers - offering consumers 70% off on thousands of home furnishings and home improvement items.
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GURE | Hot Stocks08:46 EDT Gulf Resources expects sales of bromine to increase 60%-65% over Q2 - Gulf Resources provides update on 3rd and 4th Quarter Bromine and Crude Salt Sales and Profits. Gulf Resources has continued to ramp up production of bromine and crude salt in the third quarter. The company said, :"We currently estimate sales of bromine in terms of tonne will increase 60-65% over that of the second quarter. Each of the months has shown an increase, with the greatest increase occurring in September 2020. At the present time, bromine is priced at approximately $4,441 per metric tonne, compared to $3,672 per metric tonne at the end of the second quarter, representing an increase of 20.9%. Crude salt sales are expected to increase about 45% in the third quarter. Sales in the third quarter are estimated to be between 75,000 and 80,000 metric tonnes, compared to 53,532 in the second quarter. While the company does not make projections, based on the expected sales level and current pricing, these businesses should operate at break-even closely. The company is very pleased with the continuing progress being made in its bromine and crude salt facilities. The company expects that October 2020 will also be a good month in terms of bromine sales. November sales also expected to be strong, although it may be lower than October. December is likely to be seasonally weaker as customers reduce purchases of raw materials in advance of the Chinese New Year. As a reference, in 2015 and 2016, the third quarter contributed approximately 29.3% of bromine tonnes sold compared to 18.5% in the fourth quarter. In these two years, bromine sales in tonnes were approximately 58.6% higher in the third quarter than in the fourth quarter. In addition, crude salt production can be negatively impacted by cold weather. There is no way to predict the weather in December. In 2016, when the weather was mild, we sold more tonnes of crude salt than in any other quarter of the year. However, at this point in time, it is impossible to predict the weather for November and December. Given our assumptions that weather could impact crude salt sales and that customers are likely to reduce bromine purchases prior to the Chinese New Year, the company still believes it may operate are break-even closely. The company plans to report 2020 third quarter results around mid-November, 2020."
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ADXS | Hot Stocks08:44 EDT Advaxis adopts limited duration stockholder rights plan - Advaxis announced that its Board of Directors has approved the adoption of a limited duration stockholder rights plan and declared a dividend distribution of one right for each outstanding share of common stock. The record date for such dividend distribution is October 12, 2020. The rights plan expires, without any further action being required to be taken by the Company's Board of Directors, on September 28, 2021. The adoption of the rights plan is intended to protect Advaxis and its stockholders from the actions of third parties that Advaxis' Board of Directors determines are not in the best interests of Advaxis and its stockholders, and to enable all stockholders to realize the full potential value of their investment in Advaxis. The rights plan was not adopted in response to any specific takeover proposal or any currently threatened or pending effort to acquire control of Advaxis of which the Board of Directors is aware. The rights plan was adopted to provide the Board of Directors with time to make informed decisions that are in the best long-term interests of Advaxis and its stockholders and does not prevent Advaxis' Board of Directors from considering any offer to acquire Advaxis that it considers to be in the best interest of Advaxis' stockholders. The rights plan is similar to stockholder rights plans adopted by other publicly-traded companies. Under the rights plan, the rights generally would become exercisable only if a person or group acquires beneficial ownership of 10% or more of Advaxis' common stock in a transaction not approved by Advaxis' Board of Directors. In that situation, each holder of a right will have the right to purchase, upon payment of the exercise price and in accordance with the terms of the rights plan, a number of shares of Advaxis' common stock having a market value of twice such price. In addition, if Advaxis is acquired in a merger or other business combination after an acquiring person acquires 10% or more of Advaxis' common stock, each holder of the right would thereafter have the right to purchase, upon payment of the exercise price and in accordance with the terms of the rights plan, a number of shares of common stock of the acquiring person having a market value of twice such price. The acquiring person or group would not be entitled to exercise these rights. In the rights plan, the definition of "beneficial ownership" includes derivative securities. Stockholders who beneficially owned 10% or more of Advaxis' outstanding common stock prior to the first public announcement by Advaxis of the adoption of the rights plan will not trigger any penalties under the rights plan so long as they do not acquire beneficial ownership of any additional shares of common stock at a time when they still beneficially own 10% or more of such common stock, subject to certain exceptions as described in the rights plan.
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SLP | Hot Stocks08:44 EDT Simulations Plus in 'accelerated' phase of pact with large pharma company - Simulations Plus announced that it has entered into an accelerated second phase of its collaboration with a large pharmaceutical company to tailor its high-throughput pharmacokinetic, HTPK, simulation functionality within ADMET Predictor to support the sponsor partner's lead selection activities for small molecule programs. "The feedback received from our partner on the first phase of customization work has been overwhelmingly positive, and they have identified several additional enhancements which will solidify our HTPK Simulation technology as a key component aligning research teams in discovery with early development," said Dr. David Miller, vice president of ADMET Cheminformatics at Simulations Plus. "These improvements, coupled with other software engineering advances implemented in the recent APX release, will make it possible for exposure predictions and optimal dose estimates to factor into compound prioritization decisions at the discovery stage." "Our unique ability to collaborate 1-on-1 with companies is the definition of a win-win-win outcome," added John DiBella, Lancaster division president for Simulations Plus. "For our sponsoring partner, they are able to design new functionality and workflows tailored to their specification within a commercially supported and validated platform. For Simulations Plus, we can leverage funding, external scientific expertise, and, most importantly, novel data to drive advances in modeling and simulation science. Finally, our entire user community can access these new capabilities to accelerate research timelines and develop better medicines more efficiently for the patients we all serve. We welcome and invite future collaborations across our entire suite of software programs."
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PBIP | Hot Stocks08:43 EDT Prudential Bancorp announces updated loan deferral information - Prudential Bancorp announced updated loan deferral information which includes a substantial decrease in the amount of loans on temporary deferral compared to June 30, 2020. As of September 15, 2020, loan deferrals totaled approximately $4.9 million, or 0.7%, of total loans as of such date compared to approximately $149.7 million, or 21.6%, of total loans on deferral at June 30, 2020. The loans still on deferral at September 15, 2020 consisted of six commercial loans, four of which with an aggregate principal balance of approximately $644,000 were still in the first 90 day deferral period. Of the six loans still on deferral, two are participation interests totaling approximately $4.3 million for which the Bank is not the lead lender, and which relate to one borrowing relationship. The four remaining loans are all related to one borrowing relationship. All the loans which are no longer on temporary deferral are current in their loan payments.
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GNSS | Hot Stocks08:43 EDT Genasys receives second contract to power delivery of emergency alerts - Genasys announced that it has been awarded a multi-year contract from a second mobile telecom carrier to deliver emergency alerts for Australia's next-generation early warning system. The Company recently announced it had been awarded a multi-year contract from mobile network operator, Optus. Australia's Emergency Alert System helps keep residents and visitors informed and safe during bushfires and other critical events.
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VERU | Hot Stocks08:42 EDT Veru completes enrollment of Phase 2 trial of VERU-111 - Veru announced that it has fully enrolled its Phase 2 clinical study of VERU-111, its novel, oral, alpha and beta tubulin targeting drug for metastatic castration and novel androgen receptor targeting agent resistant prostate cancer. The study enrolled a total of 40 men at 13 clinical sites in the United States. The open label, single arm, Phase 2 clinical trial will evaluate the efficacy and safety of VERU-111 in 40 men with metastatic prostate cancer who have become resistant to at least one androgen receptor targeting agent, but prior to IV chemotherapy in the metastatic setting. Enrolled men will receive 63 mg of VERU-111 per day, the recommended dose selected from the Phase 1b portion of the study which was conducted in 39 men. In the Phase 1b study, VERU-111 63mg oral daily continuous dosing chronic administration was well tolerated with no reports of neurotoxicity, hypersensitivity reactions and neutropenia. Promising antitumor activity was also observed in the Phase 1b clinical study with evidence of PSA declines, objective tumor responses, and durable responses. The key efficacy endpoint of the Phase 2 study is radiographic imaging of progression-free survival.
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RVVTF | Hot Stocks08:41 EDT Revive finalizes five clinical sites for Phase 3 trial for bucillamine - Revive Therapeutics announced an update on the Company's U.S. Food & Drug Administration Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19. The Company has selected and finalized with five clinical sites in Florida, Texas and California for enrollment of patients in the Phase 3 clinical study, and is finalizing agreements with an additional ten clinical sites in these states including Arizona and Ohio where patient enrollment should start in October within these other locations.
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CACI | Hot Stocks08:41 EDT CACI awarded up to $59M task order by OUSD for operational support - CACI announced that it has been awarded a four-year, 10-month task order, with a ceiling value of more than $59M, by the Office of Under Secretary of Defense, or OUSD, to provide enterprise expertise and technology in support of the Defense Finance and Accounting Service's Comptroller critical mission systems. Under the task order, CACI will provide onsite operational support to the program and budget systems of OUSD in the areas relating to system maintenance, information security/assurance, integration, conversion, migration, report generation, documentation, training and guidance. Awarded under the GSA Alliant 2 contract, the task order represents continuing work for CACI. This work will include continual, on-site software maintenance, technical support, and development support of software products for OUSD's automated mission systems, which assist the comptroller in managing the Defense Department's budget, which for FY19 totaled more than $686B. CACI will provide continued delivery of rapid, cost-effective software and support for enhancing the systems and for resolving defects, as well as complete life-cycle support, management and documentation for the OUSD Resource Management Systems suite.
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OSIS | Hot Stocks08:40 EDT OSI Systems gets $5M in orders for electronic sub-assemblies - OSI Systems announced that its Optoelectronics and Manufacturing division has received orders for approximately $5M to provide electronic sub-assemblies for an innovative water solutions provider. OSI Systems' Chairman and Chief Executive Officer, Deepak Chopra, stated, "We are pleased to continue supporting this long-standing customer by providing components for its touchless sanitation products."
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MYOV | Hot Stocks08:40 EDT Myovant: Relugolix did not achieve statistical superiority in Phase 3 HERO study - Myovant Sciences announced results of an additional secondary endpoint from the Phase 3 HERO study evaluating relugolix in men with advanced prostate cancer. Relugolix did not achieve statistical superiority for castration resistance-free survival compared to leuprolide acetate in men with metastatic disease through 48 weeks. Castration-resistant prostate cancer is defined by disease progression despite achieving testosterone suppression to castrate levels. In the subgroup of men with metastatic disease treated with relugolix, 74% were castration-resistance free through 48 weeks compared to 75% men treated with leuprolide acetate. In the secondary endpoint analysis, castration resistance-free survival was defined as the time from first dose to prostate-specific antigen progression per the Prostate Cancer Clinical Trials Working Group 3 criteria or death from any cause. PSA progression was defined as a PSA increase greater than or equal to 25% and greater than or equal to 2 ng/mL above the nadir, and confirmed by a second PSA value greater than or equal to 3 weeks later. The incidence of adverse events in the subgroup of men with metastatic disease was consistent with that observed in primary analysis of HERO with no new safety signals observed. Relugolix is under Priority Review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of December 20, 2020. In the Phase 3 HERO study, relugolix met the primary efficacy endpoint, with 96.7% of men treated with relugolix achieving sustained testosterone suppression to castrate levels through 48 weeks versus 88.8% of men treated with leuprolide acetate. Relugolix also met six key secondary endpoints, demonstrating rapid and profound suppression of testosterone and PSA response, in addition to improved testosterone recovery after discontinuation of treatment. Men in the relugolix group had a 54% lower risk of major adverse cardiovascular events compared to men in the leuprolide acetate group. In men with a reported history of MACE, the relugolix group had 80% fewer MACE events reported compared to the leuprolide acetate group. The overall incidence of adverse events in the relugolix and leuprolide acetate groups was comparable.
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ENV | Hot Stocks08:39 EDT Envestnet appoints Dana D'Auria as Co-Chief Investment Officer - Envestnet announces that Dana D'Auria has joined the organization as Co-Chief Investment Officer of Envestnet. In her new role, she will join Envestnet PMC's Investment Committee, and utilize her expertise to further grow and align PMC's fiduciary solutions and other resources, including overlay services, research and portfolio management. D'Auria most recently served as Managing Director of Symmetry Partners, where she has worked for the last 14 years and also served as President and Portfolio Manager of Symmetry Panoramic Mutual Funds, the firm's multi-factor family of funds. At Symmetry Partners, D'Auria led the investments/research, mutual fund, and investment communications departments, and helped develop new investment strategies to meet the needs of clients.
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ITI | Hot Stocks08:39 EDT Iteris awarded $4.7M traffic signal synchronization project by OCTA - Iteris announced that it has executed the final contract and received the formal notice to proceed for a $4.7M initiative with the Orange County Transportation Authority, or OCTA, for a regional traffic signal synchronization project. The three-year project includes signal coordination and timing improvements, with the aim of improving traffic flow, enhancing public safety and decreasing stops. Under the project agreement, Iteris will provide services that will upgrade traffic signal electronics and communications equipment, and optimize signal timing along Katella Avenue. On January 7, Iteris announced that it had been awarded a $3.6M contract to perform the same services across Orange County's Main Street corridor. Iteris expects to commence the traffic signal coordination and ITS design project immediately.
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VMW | Hot Stocks08:38 EDT VMware delivers multi-cloud strategy, acquires SaltStack for automation - This week at VMworld 2020, VMware announced new innovations to help customers build, run, manage, connect, and protect any app on any cloud. " Today, more than 15M enterprise workloads run on VMware in the cloud, and more than 4,300 partners offer VMware-based cloud services. This includes all major public cloud providers. With these new and updated offerings, customers and partners can unlock multi-cloud's full potential value by providing more developer freedom while providing IT with consistent and efficient security and operations. The company also announced its intent to acquire SaltStack, a pioneer in building intelligent, event-driven automation software. Following close, SaltStack will enable VMware to significantly broaden its software configuration management and infrastructure and network automation capabilities. "VMware has reached a major milestone in its plan to unlock the power of every cloud for every business. We now support customers' application strategies by delivering VMware-based services on every major public cloud provider and hundreds of VMware Cloud Verified partners worldwide," said Raghu Raghuram, chief operating officer, products and cloud services, VMware...VMware supports organizations across all clouds and all application types. The company offers a complete cloud portfolio that delivers consistent infrastructure and operations and enables a flexible and agile developer model. At VMworld, VMware is announcing Migrating and Modernizing Apps on VMware Cloud on AWS: VMware Cloud on AWS (AMZN) momentum continues to grow. As of August 2020, total VMs are up 140% and the total number of hosts are up 130% year over year on VMware Cloud on AWS. VMware Cloud Management enables organizations to consistently deploy, operate, and govern applications, infrastructure, and platform services across any cloud environment. New cloud management innovations include the following: Innovative Cloud Management Hybrid Subscription Solution"
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XGN | Hot Stocks08:37 EDT Exagen announces agreement with Provider Network of America for AVISE tests - Exagen announced that it has entered into a preferred provider network agreement with Provider Network of America. Under the terms of the agreement, over 8 million PNOA members in the U.S. will have in-network access to Exagen's unique suite of AVISE tests for autoimmune disorders, including rheumatoid arthritis and lupus. PNOA is a nationwide, direct contracted provider network accessed by 526 payers, which has over 375,000 contracted physicians and 12,000 hospitals and ancillary facilities under contract, assuring reliable access to healthcare for providers, payers and patients. More than 8 million PNOA members have access to PNOA's preferred provider organization network through a client base consisting of cost containment companies, third party administrators, commercial payers, Taft-Hartley Trust plans and Native American Tribal Plans.
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AA | Hot Stocks08:36 EDT Alcoa announces San Ciprian aluminum plant consultation ends without agreement - The formal consultation process regarding the San Ciprian aluminum plant in Spain officially ended without an agreement with the workers' representatives. Alcoa will now have up to 15 days to determine and announce a decision regarding the smelter's 228,000 metric tons of annual capacity. On August 13, Alcoa announced it had agreed to extend the formal consultation period for collective dismissal so the company could consider a potential sale of the aluminum plant to GFG Alliance. After a comprehensive negotiation process, GFG Alliance and Alcoa did not agree on terms. Per an agreed-upon timeline, if a sales agreement was not reached by September 27, Alcoa and the workers' representatives would then meet for one day to agree on a social plan that would include government-supported unemployment benefits or the implementation of a permanent collective dismissal. On September 28, the workers' representatives declined to agree on a social plan, and Alcoa has 15 days, per Spanish regulations, to make a decision. On June 25, Alcoa began the formal consultation process to discuss a reorganization plan with the workers' representatives. The plan, aimed at halting persistent and recurring financial losses at the aluminum plant, recommended curtailment of the smelter while keeping a portion of the site's casthouse operational. The alumina refinery at San Ciprian was not included in the consultation or the sales process.
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WTT | Hot Stocks08:35 EDT Wireless Telecom Group joins NSC, IWRP to contribute 5G solutions - Wireless Telecom Group announced its membership to the National Spectrum Consortium and the Information Warfare Research Project Consortium to collaborate on the research, development, and implementation of 5G-based technologies. Wireless Telecom Group will leverage its expertise in specialized 5G radio access network solutions to contribute to the development of next generation 5G network applications. The National Spectrum Consortium was founded to foster collaboration among industry, academia, and government agencies working to solve the toughest problems facing the nation with regard to 5G, 5G-based technologies, and spectrum access and sharing. The Information Warfare Research Project Consortium, is a consortium focused on advancing information warfare capabilities to enhance United States Navy and United States Marine Corps mission effectiveness, with specific technology focus areas that include assured communications, Internet of Things enabled systems, and mobility.
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BYSI | Hot Stocks08:34 EDT BeyondSpring announces publication of manuscript on plinabulin - BeyondSpring announced that the Company's manuscript, titled "Efficacy of Plinabulin vs. Pegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Adults With Non-Small Cell Lung Cancer," has been published in JAMA Oncology, the American Medical Association's peer-reviewed journal. The manuscript analyzed BeyondSpring's Phase 2 portion of its PROTECTIVE-1 randomized clinical trial, which consisted of four treatment arms and was conducted in 19 treatment centers in the U.S., China, Russia and Ukraine from April 2017 through March 2018, with Covance serving as its contract research organization. Key primary and secondary endpoints were calculated using objective data, such as the absolute neutrophil count and platelet counts, which were based on validated assays conducted at Covance's central labs in three continents. Participants were adult patients with non-small cell lung cancer whose cancer had progressed after platinum-based chemotherapy. The objective was to assess the efficacy and safety of the Company's lead asset, Plinabulin, compared with Pegfilgrastim, a long-lasting G-CSF, which is currently the predominant therapy for chemotherapy-induced neutropenia prevention. The protocols were as follows: All NSCLC patients received docetaxel on Day 1 and were randomly assigned to four arms: three dose levels of Plinabulin monotherapy on Day 1 or Pegfilgrastim monotherapy on Day 2. Patients were treated every 21 days for four chemotherapy cycles.Key results included: Plinabulin's CIN effect in terms of Grade 4 frequency was dose-dependent, and the 20 mg/m2 was selected as the Phase 3 dose. Plinabulin as a single agent was equally effective as Pegfilgrastim for preventing Grade 4 neutropenia and infections. In contrast to Pegfilgrastim, patients who received Plinabulin maintained their overall quality of life and experienced significantly less bone pain and less thrombocytopenia.
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IMMR | Hot Stocks08:34 EDT Immersion signs multi-year license renewal with LG for TouchSense software - Immersion announced that it has signed a multi-year license renewal with LG Electronics for continued use of TouchSense software and haptic technologies in its mobile devices. The company said TouchSense software makes it easy to program haptic effects for basic and intricate use cases that require high fidelity haptic rendering to feel real.
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BCDA | Hot Stocks08:32 EDT BioCardia issued patent for delivery of cardiac cell therapy - BioCardia announced the issuance of U.S. Patent No: 10,780,248 for a "Radial and Transendocardial Delivery Catheter" that further protects the Helix Biotherapeutic Delivery System and enhances its cell therapy delivery capabilities. The patent does not expire until after September 29, 2034. This patent covers a needle injection catheter system appropriate for transradial biotherapeutic delivery to the heart, and strengthens the Company's clinical stage biotherapeutic programs in heart failure and chronic myocardial ischemia.
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ASC | Hot Stocks08:32 EDT Ardmore Shipping announces new $30M share repurchase plan - Ardmore Shipping announced that the company's Board of Directors has authorized a new Share Repurchase Plan, expanding and replacing the company's earlier plan. Pursuant to the New Plan, Ardmore may purchase up to $30M of the company's common shares through to September 30, 2023, at times and prices that are considered to be appropriate by the company.
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SINO | Hot Stocks08:32 EDT Sino-Global signs MOU of joint venture with Tianjin Anboweiye Technology - Sino-Global Shipping America announced that it has signed an MOU of joint venture with Tianjin Anboweiye Technology. The newly joint venture company will help Sino-Global to build up its Hi-Tech and Information-based logistic services enhance to meet the higher and complicate demand of customers.
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APRE | Hot Stocks08:32 EDT Aprea Therapeutics appoints Michael Kelly to board of directors - Aprea Therapeutics announced the appointment of Michael A. Kelly to its Board of Directors. Mr. Kelly will serve as a member of the audit committee and nominating and corporate governance committee. Kelly brings more than 20 years of executive leadership in the life sciences industry, including 14 years in senior leadership roles with Amgen Inc., and is the Founder and President of Sentry Hill Partners, LLC, a global life sciences management consulting business.
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RCM | Hot Stocks08:31 EDT R1 RCM increases footpring in hospital-based physician market - R1 RCM announced its continued expansion into the hospital-based physician market with the addition of EMpower Emergency Physicians, a premier physician group in Arizona, and Integrated Care Physicians, a rapidly-expanding emergency medicine and hospitalist provider management company in Tampa, Florida. EMpower Emergency Physicians selected R1 to provide revenue cycle management services across the group's emergency department presence at acute care hospitals and freestanding emergency departments to drive enhancements in patient satisfaction, quality and performance and gain better visibility into the financial, clinical and operational sides of the business. Integrated Care Physicians selected R1 to provide revenue cycle management services across their provider management network to achieve cost savings and increase revenue yield.
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CLCT MSFT | Hot Stocks08:30 EDT Collectors Universe enters settlement agreement with Alta Fox - Collectors Universe (CLCT) announced the appointment of Lorraine G. Bardeen to its Board of Directors, effective immediately. In connection with her appointment, the Company has entered into a settlement agreement with Alta Fox Capital Management, which owns approximately 5.4% of Collectors Universe's outstanding shares. Separately, the Board also announced the appointment of Jennifer H. Leuer to the Collectors Universe Board of Directors, effective immediately. Ms. Bardeen serves as VP and Chief Technology Officer of World Wide Enterprise and Commercial Industries at Microsoft (MSFT). Leuer serves as Chief Executive Officer of CyberScout. With the appointment of Ms. Bardeen and Ms. Leuer, the Board will comprise 10 directors, 9 of whom are independent. The Board has also appointed A.J. "Bert" Moyer as Chairman of the Board. Bruce A. Stevens will continue his service to the Board as a director following the conclusion of his tenure as Chairman. In addition, two current directors, Deborah A. Farrington and Joseph R. Martin, have informed the Board that they will not stand for re-election to the Board at the Company's 2020 Annual Meeting.
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LMND | Hot Stocks08:28 EDT Lemonade announces early lock-up expiration extension - Lemonade announced an extension of the early lock-up expiration date pursuant to the terms of lock-up agreements with the underwriters of its initial public offering of common stock until one business day following the release of earnings for the third quarter of 2020. In connection with the company's IPO, all of its executive officers, directors, and substantially all of the holders of the company's common stock, or securities exercisable for or convertible into the company's common stock outstanding immediately prior to the IPO, are parties to market standoff agreements with the company or entered into lock-up agreements that restrict their ability to sell or transfer their securities, or otherwise engage in certain transactions related to their securities, for a period of up to 180 days after July 1, which is the "lock-up period," the company said. Pursuant to the lock-up agreements, the lock-up period is scheduled to end with respect to 33% of the securities subject to each lock-up agreement on September 29, 2020, which falls within the company's quarterly blackout period. Therefore, in accordance with the lock-up agreements, the lock-up period with respect to 33% of the securities subject to each lock-up agreement will end one business day following the release of earnings for the third quarter, which date will be separately announced. The company will also release the same portion of securities restricted under the market standoff agreements on the early lock-up expiration extension date, Lemonade said. The company estimates that, based on the number of shares of the company's common stock, which as of September 29, 2020 are: outstanding or subject to stock options that have vested, approximately 15,058,356 shares of the company's common stock may become eligible for sale in the public market at the open of trading on the early lock-up expiration extension date. This includes 9,899,362 shares held by affiliates which are subject to volume and other restrictions of Rule 144 of the Securities Act of 1933, as amended.
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NTLA | Hot Stocks08:27 EDT Intellia Therapeutics presents preclinical data on in vivo CRISPR/Cas9 edits - Intellia Therapeutics is presenting new data demonstrating the persistence of in vivo CRISPR/Cas9 edits to either reduce a disease-causing protein or restore a functional protein, in a mouse model of accelerated liver regeneration. These data will be included in the company's invited talk at this year's 16th Annual Meeting of the Oligonucleotide Therapeutics Society, taking place virtually from September 27-30, 2020. The OTS talk titled, "A Modular CRISPR/Cas9 Genome Editing Platform for Durable Therapeutic Knockout and Targeted Gene Insertion Applications," will be given today at 10 a.m. ET by Anthony Forget, Ph.D., senior director of genome editing at Intellia. Persistent In Vivo Liver Gene Knockouts and Corresponding Protein Reduction Achieved Employing Intellia's Modular Platform: Accelerated hepatocyte turnover following PHx in mice was employed to assess the durability of gene knockout and insertion edits. After resection of 2/3 of the liver, and subsequent full-liver regeneration, genome edits and corresponding protein levels were unchanged, supporting the permanent nature of the edit, which is carried through when liver cells proliferate. This update builds upon previously reported data of the edits' year-long durability demonstrated in rodents and non-human primates for Intellia's liver knockout therapeutic candidates, transthyretin amyloidosis and hereditary angioedema. Intellia's lead in vivo candidate, NTLA-2001, is being studied as a single-course treatment for ATTR using the company's liver knockout editing approach. NTLA-2001 employs a proprietary lipid nanoparticle delivery system and is designed to permanently inactivate the disease-causing gene in the liver. Knocking out the transthyretin gene may lead to a lifelong reduction of TTR protein and associated ATTR symptoms. The company expects to dose the first ATTR patient by year-end with NTLA-2001, which is part of a co-development/co-promotion agreement between Intellia, the lead development and commercialization party, and Regeneron Pharmaceuticals, Inc. The modularity of Intellia's proprietary platform allows Intellia to modify only a single component, the guide RNA sequence, to develop other in vivo therapies for additional targets of interest. Intellia also is applying its LNP delivery system to develop NTLA-2002 to treat HAE by targeting and knocking out the prekallikrein B1 gene in the liver. The company anticipates submitting an Investigational New Drug application or IND-equivalent for NTLA-2002 in the second half of 2021. CRISPR-Mediated Targeted Gene Insertion Has Demonstrated Advantages Over AAV-Based Gene Therapy Approaches: Intellia will present additional data highlighting the potential of its liver insertion platform, as exemplified by the company's hemophilia B program. Intellia and Regeneron, the lead party, are co-developing potential hemophilia A and B CRISPR/Cas9-based treatments using their jointly developed targeted transgene insertion capabilities. Data shows the company achieved circulating activity levels for Factor IX, a blood-clotting protein that is missing or defective in hemophilia B patients, ranging from normal levels to supratherapeutic levels in a six-week non-human primate study. Insertion efficiency and transgene expression can be controlled by three independent factors: the precise insertion site targeted by the guide RNA; the dose of LNP, which delivers the CRISPR machinery; and the amount of the promoter-less DNA template donor that encodes the transgene's DNA sequence for insertion. These levers allow for optimization of transgene expression according to the desired therapeutic target levels and may allow for higher levels of expression than those attained by traditional adeno-associated virus gene therapy, if required. Furthermore, unlike traditional gene therapy, for which a significant loss in transgene expression was observed after in vivo PHx and liver regeneration, Intellia's targeted gene insertion approach yielded durable edits as cells proliferate, with no significant loss in expression. These findings support the development of gene insertion therapies.
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CRNC | Hot Stocks08:25 EDT Cerence, PATEO selected by SGMW for conversational AI - Cerence announced that SAIC-GM-Wuling Automobile has selected Cerence and PATEO to develop first-of-its-kind, cloud-based voice recognition for its cars in Indonesia, a major milestone for automotive assistant technology in the region. This new, cloud-based automotive assistant is an extension of Cerence and SGMW's previous work to build Wuling Motors' award-winning WIND, Indonesia's first Indonesian-language voice control technology platform based on embedded voice recognition technologies. Together with PATEO, Cerence now brings a hybrid approach to SGMW cars, providing conversational AI and natural language understanding technology in both the cloud and embedded in the car, as well as on-board text-to-speech, to deliver a highly intelligent, lightning-fast, and interactive assistant experience.
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KTOS | Hot Stocks08:24 EDT Kratos Defense awarded multi-million dollar contract for target system aircraft - Kratos Defense & Security Solutions announced that Kratos has received a multi-million dollar order for 20 high performance target system aircraft from a key, long-term, international customer. Work under this contract will be primarily conducted in Kratos' facility in Oklahoma City, OK.
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AMZN SFIX | Hot Stocks08:23 EDT Amazon launches $4.99 per month personal shopping service for men - Amazon (AMZN) launched a $4.99 per month personal shopping service for men, an expansion of its existing Prime Wardrobe service. The new service will compete with Stitch Fix (SFIX). Reference Link
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BDRBF | Hot Stocks08:23 EDT Bombardier enters share purchase agrrement with Lufthansa Technik, ExecuJet - Bombardier announced that the company has entered into share purchase agreements with each of Lufthansa Technik AG and ExecuJet Aviation Group AG to acquire all of the issued and outstanding shares of Lufthansa Bombardier Aviation Services that it does not own. This transaction enables Bombardier to further expand its worldwide customer support footprint by establishing a wholly-owned service centre in Berlin. The transactions are subject to customary closing conditions with closings anticipated to occur before the end of the year. Strategically located at Berlin-Schonefeld airport, the service centre has been providing exceptional MRO services to Bombardier business aircraft customers since 1997. With more than 160,000 sq. ft. of service capacity and 240 highly-skilled employees on site, the service centre provides customers with the highest-level maintenance and support for Bombardier's growing fleet of Learjet, Challenger and Global business jets based in Europe, Russia, Africa and the Middle East.
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STIM | Hot Stocks08:21 EDT Neuronetics announces 500,000 treatment milestone for Greenbrook TMS - Neuronetics congratulated Greenbrook TMS, a NeuroStar Advanced Therapy provider with 125 treatment centers across the U.S., for delivering its 500,000th transcranial magnetic stimulation treatment.
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LSAC | Hot Stocks08:20 EDT LifeSci Acquisition announces merger agreement with Vincera Pharma - LifeSci Acquisition and Vincera Pharma announced that they have entered into a definitive agreement for a business combination. The combined company is expected to have approximately $60 million in cash at closing. In addition, it is expected that LSAC will be renamed Vincera Pharma, Inc. and the combined company's common stock will remain listed on The Nasdaq Capital Market under the new ticker symbol "VINC." Post-closing, stockholders will include Acuta Capital, RTW Investments, Surveyor Capital, Logos Capital, EcoR1 Capital, Perceptive Advisors, Boxer Capital of Tavistock Group, Monashee Investment Management, Altium Capital, and Affinity Asset Advisors. Proceeds from the transaction will provide Vincera with capital and the flexibility of being a publicly listed company to accelerate the growth of their pipeline, currently driven by an exclusive option to license agreement with Bayer for an oncology portfolio, which includes a highly selective, clinical-stage PTEFb/CDK9 inhibitor, as well as a preclinical bioconjugation platform developed to overcome the limitations of antibody and small molecule drug conjugates. Vincera will be led by Chief Executive Officer, Ahmed Hamdy, M.D., cofounder of Acerta Pharma BV and former Chief Medical Officer of Pharmacyclics LLC, along with an experienced management team who brings a successful track record in discovering and developing blockbuster oncology drugs. The Boards of Directors of LSAC and Vincera have unanimously approved the merger and related agreements and transactions. In connection with the merger, stockholders of Vincera and certain stockholders of LSAC will be entering into a voting agreement relating to the nomination and election of directors of the combined company following the merger. Completion of the merger is subject to approval of LSAC's stockholders; the execution of a definitive license agreement with Bayer providing Vincera with certain rights and obligations with respect to Vincera's expected product candidates; and other customary closing conditions, including a definitive proxy statement being filed with the Securities and Exchange Commission. The transaction is currently expected to be completed in the fourth quarter of 2020. LSAC raised $66 million in its IPO, which is now held in a trust account. Under the terms of the proposed transaction announced today, LSAC will issue 5.5 million shares of its common stock to current securityholders of Vincera upon the closing of the proposed transaction. These Vincera stockholders may also receive, subject to the terms of the merger agreement, up to an additional 6.0 million shares of LSAC common stock based on the daily volume weighted average share price of LSAC common stock in any 20 trading days within a 30 trading day period: 2.0 million shares if the share price exceeds $20.00 prior to the 42 month anniversary of the closing, an additional 2.0 million shares if the share price exceeds $35.00 prior to the six year anniversary of the closing, and an additional 2.0 million shares if the share price exceeds $45.00 prior to the eight year anniversary of the closing. Assuming no redemption from LSAC stockholders, it is estimated that the current stockholders of Vincera will own approximately 40% of the issued and outstanding common stock of the combined company at closing. Post-closing, Ahmed Hamdy and Raquel Izumi from Vincera will join Andrew McDonald and Chris Lowe from LSAC, along with five independent directors on the nine-person Board of Directors.
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AQMS | Hot Stocks08:18 EDT Aqua Metals receives additional $1.5M insurance payment - Aqua Metals announced it has received an additional progress payment of $1.5 million from its insurance provider. The Company has now collected a total of $21.8 million of insurance proceeds related to the November 2019 fire event. Of the total proceeds received to date, $14.2 million have been paid to Aqua Metals and the balance of $7.6 million have been allocated to the retirement of the Veritex Bank loan. Including this payment, Layer 3 has now paid out $9.3 million, which is approximately 75% of the total Layer 3 insurance coverage amount of $12.5 million. Layer 4, for which the Company previously submitted property, casualty and business interruption claims, accounts for the remaining $25.0 million of the potential $50.0 million of total collections. The Company continues to collaborate with its insurance provider and is making progress toward receiving additional anticipated progress payments.
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FDS | Hot Stocks08:17 EDT FactSet launches coverage of Danish bonds - FactSet announced that it has launched content and analytics for Danish covered bonds across its distribution channels, including the FactSet workstation. The company is working with Scanrate, a leading provider of fixed income software, models, and data for the Danish bond market, to deliver increased coverage of the Danish market.
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SWM | Hot Stocks08:17 EDT SWM increases production of Alphastar Electrostatic Media product - SWM International is ramping up production of its Alphastar Electrostatic Media product at its Wilson, North Carolina manufacturing facility. Alphastar Electrostatic Media is a primary component in HVAC air filtration products, including MERV 13 rated air filters. The company is expanding the workforce at the facility to support the higher production level and is continuing to evaluate further actions to increase output. This follows efficiency projects earlier in 2020 to increase capacity on the existing production lines. SWM anticipates ongoing demand for Alphastar media as commercial and residential customers respond to recommendations from the Centers for Disease Control and ASHRAE to upgrade building filtration to a minimum of MERV 13, which requires more frequent changes compared to lower level filters such as MERV 8.
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IRWD | Hot Stocks08:16 EDT Ironwood down over 10% after discontinuing IW-3718-302, cutting staff - Shares of Ironwood are down 10.5% or $1.00 at $8.53 after the company announced its plans to discontinue IW-3718 development and reduce headcount by 35% accompanying its disclosure that one if its two Phase III trials evaluating IW-3718 in refractory gastroesophageal reflux disease, or GERD, did not meet the pre-specified criteria.
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HIL | Hot Stocks08:15 EDT Hill International selected to support transportation infrastructure projects - Hill International announced it was selected by the European Investment Bank to support the EIB's Project Advisory Support Team in the implementation of transportation-related infrastructure projects in Romania, Bulgaria, Poland, and Croatia. Under a framework agreement, Hill's subject matter experts will provide expertise to EIB-supported projects to accelerate project planning and execution, as well as European Union structural and investment funds absorption. Supported projects may involve roads, rail, light rail and bus lines, aviation, waterborne transit, logistics platforms, and/or intermodal platforms.
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CSGS | Hot Stocks08:14 EDT CSG's Forte Payment System in strategic pact with Accela - Forte Payment System, a CSG company, announced a strategic partnership with Accela to provide a powerful payments processing engine for Accela's SaaS solutions. Together, the two organizations will streamline processes for residents, contractors, and government agencies, leveraging a best-in-breed, integrated solution for online and in-office transactions. Governments must navigate new business and citizen needs in light of the COVID-19 pandemic. As work-from-home mandates for citizen and agency employees have complicated team workflows for accepting paper or in-person payments, online transactions have become an absolute requirement. Agencies are also under pressure to keep costs low while also providing robust online services for transactions related to regulatory processes and business growth opportunities. This partnership will empower government agencies to refine otherwise cumbersome manual processes for evolving regulatory and business procedures. Accela customers leveraging this integration will gain value with a partner like Forte that can serve as a gateway for 90 percent of online payment processors. Moreover, this partnership provides a cost-competitive solution that enables customers to process service and convenience fees. Forte has a long history of delivering innovative solutions to help manage customers' payments processing needs," said Jeff Thorness, head of payments solutions, CSG. "The ability to partner and integrate with Accela's SaaS solutions will give government agencies the ability to benefit from an end-to-end dual partnership that simplifies and increases business operation efficiencies."
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LAUR | Hot Stocks08:13 EDT Laureate Education closes sale of INTI Education Group - Laureate Education announced that it has closed on the previously announced sale of INTI Education Holdings to HOPE Education Group Company Limited. The total transaction value was $140M. Laureate's net proceeds from the transaction are estimated to be approximately $120M after a $14M payment to a minority equity shareholder and other fees.
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HSTO | Hot Stocks08:12 EDT Histogen says HST-002 designated as drug-biologic-device combination product - Histogen announced that it received communications from the Office of Combination Products, a division of the United States Food and Drug Administration, that HST-002 is a drug-biologic-device combination product and will be assigned to the Center for Biologics Evaluation Research Office of Tissues and Advanced Therapies as the agency lead for premarket review and regulation. In April of 2020, Histogen had submitted an IDE application for HST-002 based upon its primary mechanism of action and historical regulatory precedence for approved dermal fillers. "Assuming the IDE had been granted by FDA, we planned to initiate a Phase 1 clinical trial designed to assess the safety and tolerability of HST-002, as well as look for early indications of efficacy versus Restylane-L in moderate to severe nasolabial folds, in the fourth quarter of 2020," said Richard Pascoe, Histogen's President and CEO. "Based upon FDA's communications that HST-002 will be regulated as a drug-biologic-device combination product, we are evaluating the impact to our clinical timeline and expect to provide an update in the fourth quarter of 2020. We remain on track to announce top line data results in the fourth quarter of this year for our HST-001 phase 1b/2a trial for androgenic alopecia in men. HST-001, if approved, could be a first-in-class product given its potential to stimulate new long-lasting hair growth in contrast to existing therapies that focus on reducing hair loss. In addition, we continue to make progress on our HST-003 program for regeneration of cartilage in the knee and anticipate filing an IND in the fourth quarter of 2020."
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WDDD MSFT | Hot Stocks08:10 EDT Worlds Inc. files patent infringement complaint against Microsoft - Worlds (WDDD) on Sept. 25th, 2020 filed a complaint, for patent infringement against Microsoft (MSFT). In the complaint, Worlds accuses Microsoft and its "Minecraft" video game product of infringing Worlds' U.S. Patent No. 8,082,501, titled "System and Method for Enabling Users to Interact in a Virtual Space". The '501 Patent was previously asserted against Activision Blizzard, Inc., though that litigation was temporarily suspended after the patent's validity was challenged in 2015 in an inter partes review petition filed by Bungie, Inc. with the U.S. Patent & Trademark Office's Patent Trial and Appeal Board. The defense of the '501 Patent included a trip to the U.S. Court of Appeals for the Federal Court, where Worlds' legal team, led by Wayne M. Helge of Davidson, Berquist, Jackson & Gowdey, convinced the CAFC that the PTAB had applied an incorrect test as part of its analysis. Finally, on January 14, 2020, the '501 Patent emerged from the inter partes review process with all claims intact.
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ARQT | Hot Stocks08:08 EDT Arcutis Biotherapeutics reports data from Phase 2 trial of ARQ-154 - Arcutis Biotherapeutics announced positive topline data from its Phase 2 clinical trial evaluating ARQ-154 as a potential treatment for seborrheic dermatitis. Roflumilast foam 0.3% administered once daily for 8 weeks demonstrated statistically significant improvement compared to a matching vehicle foam on key efficacy endpoints in subjects with moderate-to-severe seborrheic dermatitis. On the study's primary endpoint assessed at week 8, roflumilast foam 0.3% achieved an Investigator Global Assessment success rate of 73.8% compared to a vehicle rate of 40.9%. IGA success is defined as the achievement of an IGA score of 'clear' or 'almost clear' on a 5-grade scale PLUS at least a two-point change from baseline. The onset of effect was rapid, with ARQ-154 statistically separating from vehicle as early as week 2, the first visit after baseline, on IGA success as well as multiple secondary endpoints. For example, at week 8, 64.6% of subjects treated with roflumilast foam who had a baseline Worst Itch Numeric Rating Scale score of 4 achieved an itch reduction of at least 4 points compared to 34.0% of vehicle treated subjects. Other secondary endpoints included overall assessment of erythema and overall assessment of scaling, which also had positive outcomes. Importantly, roflumilast foam was well-tolerated, with rates of application site adverse events, treatment-related adverse events, and discontinuations due to adverse events low and similar to vehicle. Only 2 out of 154 subjects treated with roflumilast foam discontinued the study due to an adverse event, compared to 1 out of 72 subjects treated with the vehicle. Between December 2019 and June 2020, the Phase 2 trial enrolled 226 adult subjects with moderate-to-severe seborrheic dermatitis. This 8-week, multi-center, multi-national, double blind, vehicle-controlled study evaluated the safety and efficacy of roflumilast foam 0.3% administered once-daily to affected areas on the scalp, face, and body. Topline efficacy data, including the primary endpoint, IGA success at week 8, were analyzed using the population of all randomized subjects with the exception of subjects who missed the week 8 IGA assessment specifically due to COVID-19 disruption. Importantly, only two subjects missed the week 8 IGA assessment due to concerns arising from COVID-19, and therefore the Intent-to-Treat and modified ITT populations differed by only two subjects. Arcutis expects to present the full results from the trial at a future medical conference. Roflumilast foam is a once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 inhibitor that Arcutis is developing particularly to treat inflammatory dermatoses in hair-bearing areas of the body such as the scalp. Roflumilast has been approved by the FDA for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease since 2011. Roflumilast has shown greater potency than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis. Arcutis believes roflumilast foam has significant potential as a treatment for seborrheic dermatitis. Roflumilast foam is nearly identical to ARQ-151, Arcutis' investigational topical cream PDE4 inhibitor that has demonstrated symptomatic improvement and a favorable tolerability profile in Arcutis' clinical trials in plaque psoriasis, as well as encouraging results in atopic dermatitis. Arcutis completed enrollment in DERMIS-1 and DERMIS-2, the Company's pivotal Phase 3 clinical trials evaluating topical roflumilast cream as a potential topical treatment for plaque psoriasis, and the Company expects to announce topline data in the first quarter of 2021 and to submit a New Drug Application submission by the end of 2021. In addition, following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration, Arcutis plans to advance its program to develop topical roflumilast cream for the treatment of atopic dermatitis into Phase 3 clinical trials beginning in late 2020 or early 2021. In addition to this Phase 2 trial, Arcutis is also conducting a Phase 2 long-term safety study in seborrheic dermatitis. This is a multicenter, open-label study of roflumilast foam 0.3% applied once daily in patients with seborrheic dermatitis and will include patients who were treated previously in the Phase 2 trial, as well as patients naive to treatment with topical roflumilast foam. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement, or progression.
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BKR | Hot Stocks08:07 EDT Baker Hughes announces LNG turbomachinery order from Qatar Petroleum - Baker Hughes announced an order with longtime partner Qatar Petroleum to supply multiple main refrigerant compressors, MRCs,for Qatar Petroleum's North Field East, NFE, project, executed by Qatargas. The total award is part of four LNG "mega trains," representing 33 million tons per annum of additional capacity, which will increase Qatar's total liquefied natural gas production capacity from 77 MTPA to 110 MTPA and help to propel the Gulf nation to global LNG production leadership by 2025. This order is among the largest LNG deals secured by Baker Hughes in the past five years, for both MTPA and equipment awarded. The order reinforces more than two decades of trust and successful turbomachinery collaboration between Baker Hughes, Qatar Petroleum and Qatargas. With Qatargas already operating six existing LNG "mega trains" driven by Frame 9E gas turbine refrigerant compressors provided by Baker Hughes, the NFE project underscores the leadership of Baker Hughes LNG technology in the Gulf region and for the world's most complex LNG projects.
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PTE | Hot Stocks08:06 EDT PolarityTE announces termination of shareholder rights plan - PolarityTE announced that the board voted to terminate the company's shareholder rights plan after receiving stockholder input and evaluating that input in the context of company objectives. The termination of the shareholder rights plan, often referred to as a "poison pill," is effective September 28. Shareholders are not required, nor do they need, to take any action because of the termination of this shareholder rights plan.
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IART SNN | Hot Stocks08:05 EDT Integra to divest Extremity Orthopedics business to Smith & Nephew for $240M - Integra LifeSciences Holdings Corporation (IART) announced it has entered into a definitive agreement to sell its Extremity Orthopedics business to Smith+Nephew (SNN) for $240M in cash. The transaction is expected to close at or around the end of 2020, subject to the satisfaction of customary conditions including regulatory approvals and consultation with employee representative bodies. The transaction includes the sale of Integra's upper and lower extremity orthopedics product portfolio, including ankle and shoulder arthroplasty and hand and wrist product lines. The Extremity Orthopedics business generated revenues of $90M in 2019 and approximately $32.7M dollars during the first six months of 2020. The Company anticipates this transaction will close at or around the end of 2020 and will not have a material impact on 2020 financial results. The Company will provide a more detailed update on this transaction as part of our third quarter earnings call. Under the terms of the definitive agreement, Integra will receive $240M in cash, subject to certain customary adjustments. In connection with the transaction, Integra will pay $41.5M to the Consortium of Focused Orthopedists pursuant to the terms of certain agreements between Integra and CFO relating to the development of shoulder arthroplasty products. The Company intends to use the net proceeds in a manner consistent with its current capital allocation strategy, which may include debt reduction and/or reinvestment in both organic and inorganic opportunities.
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PME | Hot Stocks08:05 EDT Pingtan's $20M squid catches from Argentina arrive to China - Pingtan Marine Enterprise announced that the Argentina squid catches from 15 squid jigging vessels that the Company deployed in the fishing grounds located in the waters of the Southwest Atlantic Ocean have been transported back to Mawei Port in Fuzhou of China via refrigerated transport vessel. The transport vessel loaded with the catches entered the Chinese territorial waters in late August and started unloading early this morning. The total landing catches of Argentina squid is over 5100 tons, valuing over $20M based on current market price of about $4 per kg. The catches will be unloaded and delivered to the Company's warehouse in about a week.
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UTZ CAG | Hot Stocks08:04 EDT Utz Brands to purchase H.K. Anderson assets from Conagra - Utz Brands (UTZ) announced that its subsidiary Utz Quality Foods, has entered into a definitive agreement with Conagra (CAG) to acquire certain assets of the H.K. Anderson business, a leading brand of peanut butter-filled pretzels. The transaction, with a purchase price of less than $10 million which will be funded from current cash-on-hand, enables Utz to jump-start its entry into the growing filled pretzel segment, leveraging the synergies of its salty snack platform. The acquisition includes intellectual property specific to the H.K. Anderson brand and does not include employees, facilities or equipment. The transaction is expected to close in November 2020, subject to customary closing conditions. "The approximate $100 million filled segment of pretzels is ripe for innovation and growth," said Dylan Lissette, Chief Executive Officer of Utz Brands, Inc. "As we look to increase our share in the rapidly expanding salty snack category through new products and geographic growth, this type of acquisition is tailor made for the synergies and growth opportunity afforded by our platform." While traditional versions of pretzels continue to enjoy popularity, increased consumer snacking presents opportunities to accelerate momentum in the pretzel category through innovation. According to IRI, dollar sales of pretzels increased 10% percent to $1.4 billion, based on data for the 52 weeks ending September 6, 2020, an increase of more than $120M versus a year ago.
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ARTL | Hot Stocks08:03 EDT Artelo Biosciences receives ethics approval to commene CAReS study - Artelo Biosciences announced the receipt of Ethics Committee approval in the U.K. for the Company's Cancer Appetite Recovery Study entitled A Phase 1/2 Trial of the Synthetic Cannabinoid ART27.13 in Patients with Cancer Anorexia and Weight Loss. Barry J. A. Laird, M.D. of the Institute of Genetics and Molecular Medicine at the University of Edinburgh and St. Columbia's Hospice Reader in Palliative Medicine, will serve as the coordinating investigator. ART27.13 is a highly potent, peripherally restricted synthetic, dual cannabinoid agonist believed to target peripheral CB1/CB2 receptors, and has the potential to increase appetite and food intake. Artelo intends to initially develop ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss.
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IGIC | Hot Stocks08:03 EDT International General Insurance announces up to $5M share repurchase program - International General Insurance announced that its board has approved a repurchase authorization, under which the company may repurchase its common shares and/or warrants for an aggregate consideration of up to $5M.
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BBBY | Hot Stocks08:02 EDT Bed Bath & Beyond launches Same Day Delivery - Bed Bath & Beyond launched Same Day Delivery at Bed Bath & Beyond and buybuy BABY, expanding the array of omnichannel shopping services available to its customers ahead of the 2020 holiday season. Same Day Delivery follows the successful introduction earlier this year of Buy-Online-Pickup-In-Store, or BOPIS, and contactless Curbside Pickup, and will enable customers to shop their favorite products online and have them delivered to their doorstep within hours of purchase. The Company is also announcing a new strategic partnership with Shipt and Instacart. Same Day Delivery service will also be conveniently available on the Shipt and Instacart websites and mobile apps, for customers shopping for their homes, baby or holiday essentials.
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OCUL | Hot Stocks08:02 EDT Ocular Therapeutix doses first patient in OTX-CSI trial - Ocular Therapeutix announced that it has dosed the first patients in its Phase 2 clinical trial of OTX-CSI, or cyclosporine intracanalicular insert, for the treatment of dry eye disease. The Phase 2 clinical trial is a U.S.-based, randomized, masked, multi-center trial evaluating two different formulations of OTX-CSI with vehicle insert in approximately 105 subjects who will be followed for a period of 16 weeks. The enrollment of the Phase 2 trial follows the successful completion of the U.S.-based, open-label, single-center Phase 1 study evaluating the safety, tolerability and durability of OTX-CSI and assessing biological activity by measuring signs and symptoms of dry eye disease in five subjects over approximately 16 weeks. The Phase 2 clinical trial is designed to further assess the safety, tolerability and durability and evaluate the efficacy of OTX-CSI in the treatment of dry eye disease.
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FRME | Hot Stocks08:01 EDT First Merchants president, CEO Michael Rechin to retire - After more than 13 years of leading significant growth and success for First Merchants Corporation, President & CEO Michael Rechin announced he will retire from his position effective December 31, 2020. Rechin will remain on the First Merchants Board of Directors and will serve as an advisor to First Merchants going forward. Succeeding Rechin will be Mark Hardwick, current COO and CFO, who will become CEO, and Michael Stewart, current Chief Banking Officer, who will become President. Michele Kawiecki, current Senior Vice President of Finance, will become CFO. All leadership changes will be effective January 1, 2021.
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BDTX GSK | Hot Stocks07:49 EDT Black Diamond Therapeutics appoints Robert Ingram as chairman of the board - Black Diamond Therapeutics (BDTX) announced the appointment of Robert Ingram as the chairman of its Board of Directors. Brad Bolzon, Ph.D., Chairman and Managing Director at Versant Ventures and Black Diamond's founding chairman, will remain on the Company's board. Ingram served as CEO and Chairman of GlaxoWellcome, where he co-led the merger and integration that formed GlaxoSmithKline (GSK). Mr. Ingram is currently a General Partner at Hatteras Venture Partners, a venture capital firm that invests in early stage life sciences companies.
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J | Hot Stocks07:47 EDT Jacobs Engineering selected by Metra - Jacobs was selected by Metra to provide engineering and design services for the Rock Island Connection, or P2, as part of the Chicago Region Environmental and Transportation Efficiency, or CREATE, Program's 75th Street Corridor Improvement Project. Combined for logistic and environmental reasons, the 75th St. CIP is the CREATE Program's largest project and addresses Chicago's top congestion point. When constructed as part of the 75th St. CIP, P2, a double-track flyover structure will help provide faster and more reliable service on the Metra SouthWest Service line, which frequently experiences freight interference, by routing this line to join the Metra Rock Island line on its own track.
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FLDM | Hot Stocks07:46 EDT Fluidigm says funding for NIH project for COVID-19 tests increased by $22M - In a regulatory filing, Fluidigm said: "As previously disclosed in its Quarterly Report on Form 10-Q filed August 7, 2020, Fluidigm Corporation entered into a letter contract in July 2020 with the National Institutes of Health - NIH - for a project under the NIH Rapid Acceleration of Diagnostics - RADx - program aimed at increasing the number, type, and availability of tests for SARS-CoV-2, the virus that causes COVID-19. On September 28, 2020, the company executed a definitive contract with the NIH as an amendment to the letter contract to expand production capacity and throughput capabilities for COVID-19 testing with Fluidigm microfluidics technology. Pursuant to the terms of the definitive contract, the funding for the project was increased by approximately $22.0M, for a total contract value of up to approximately $34.0M upon the achievement of milestones. The project will be funded in whole or in part with Federal funds from the National Institute of Biomedical Imaging and Bioengineering, NIH, Department of Health and Human Services, under Contract No. 75N92020C0009. The contract contains a number of terms and conditions that are customary for government contracts of this nature, including, but not limited to, provisions giving the government the right to terminate the contract or to order the company to stop all or any part of the work under the contract for the government's sole convenience."
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PRFX | Hot Stocks07:44 EDT PainReform prepares for launch of its Phase 3 clinical trials of PRF-11 - PainReform announced that following the closing of its initial public offering, it has commenced preparations for the launch of its pivotal Phase 3 clinical trials of PRF-110 for the treatment of post-operative pain. Upon completion of the Phase 3 studies, if successful, the Company plans to apply for a New Drug Approval for the management of post-operative pain.less than/pgreater thanless thanpgreater thanBased on extensive toxicology and pharmacokinetic studies, as well as positive Phase 2 results, the FDA has granted the Company an IND for PRF-110 and approved the initiation of Phase 3 trials for the treatment of post-operative pain. Unlike many drug trials that take months to years to complete, which are complex and whose endpoints are difficult to interpret, the planned trials are expected to last for a brief number of days with a one-month follow-up.
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INFI RHHBY | Hot Stocks07:39 EDT Infinity receives fast track designation for eganelisib combination - Infinity Pharmaceuticals (INFI) announced that the FDA has granted fast track designation for eganelisib in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer, or TNBC, in the first-line setting. Infinity is currently enrolling patients in MARIO-3, the company's ongoing Phase 2 study in collaboration with Roche/Genentech (RHHBY) to evaluate eganelisib in a novel triple combination front-line regimen with Tecentriq and Abraxane in TNBC. Earlier this year Infinity also received fast track designation for eganelisib in combination with the checkpoint inhibitor Opdivo for the treatment of advanced urothelial cancer which the company is studying in MARIO-275, the company's global, randomized, controlled Phase 2 study in patients with advanced urothelial cancer.
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PEB | Hot Stocks07:37 EDT Pebblebrook Hotel says monthly hotel portfolio cash burn is $6M-$9M - Pebblebrook Hotel reports monthly hotel portfolio cash burn is currently running at $6 to $9M; a $9M reduction to the Company's early May midpoint estimate and a $3M further reduction to the Company's mid-August midpoint estimate: Total monthly corporate cash burn is currently running at $17 to $22 million; an $8 million reduction to the Company's early May midpoint estimate and a $2 million further reduction to the Company's mid-August midpoint estimate.
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SYK WMGI | Hot Stocks07:37 EDT Stryker extends cash tender offer for shares of Wright Medical - Stryker (SYK) announced that Stryker B.V., an indirect, wholly owned subsidiary of Stryker, has extended the offering period of its previously announced cash tender offer for all outstanding ordinary shares of Wright Medical Group (WMGI). The tender offer is being made pursuant to the purchase agreement, dated November 4, 2019, among Stryker, Stryker B.V. and Wright Medical. The tender offer is now scheduled to expire at 5:00 p.m., Eastern Time, on October 14, 2020, unless the tender offer is further extended or earlier terminated in accordance with the purchase agreement.
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FCEL | Hot Stocks07:36 EDT FuelCell announces multiple awards to provide clean energy - FuelCell Energy announces multiple project awards by the local Connecticut electric distribution companies, Eversource and United Illuminating, totaling 11.2 megawatts, as part of the state-sponsored Shared Clean Energy Facility program. Each of the four FuelCell Energy power plants to be constructed pursuant to these awards will supply 2.8 megawatts of clean power to the Connecticut electric grid. The clean baseload power generated by each FuelCell Energy 2.8 megawatt platform is enough to power approximately 3,000 homes, or a total of 12,000 homes taking into account all four FuelCell Energy platforms, with continuous clean energy. The FuelCell Energy projects selected include: A 2.8 megawatt project located in New Britain, CT; A 2.8 megawatt project located in East Hartford, CT; A 2.8 megawatt project located in Derby, CT; and A 2.8 megawatt project located in Danbury, CT. The next steps in developing these projects include working with the local electric distribution utilities to finalize the power purchase agreements, obtaining siting approvals and interconnection agreements, and finalizing site engineering. These projects will provide clean baseload power, grid resiliency benefits and renewable energy credits to the Connecticut utilities under 20-year agreements.
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MBRX | Hot Stocks07:36 EDT Moleculin discovers antiviral activity against SARS-Cov-2 in WP1096 - Moleculin Biotech announced that its research team has discovered that a molecule within its portfolio of antimetabolites has displayed significant in vitro antiviral activity against SARS-CoV-2. Independent laboratory testing of the new drug candidate, called "WP1096," has now repeatedly demonstrated a therapeutic index of greater than 10, which is considered by our team to be an industry-standard commercialization threshold for in vitro performance of antiviral drugs. Walter Klemp, Chairman and CEO of Moleculin, stated, "While we continue to see encouraging progress with WP1122 in preparation for clinical trials for the potential treatment of COVID-19, we have also continued our antiviral drug discovery program to expand the range of potential therapies. Our efforts led to a new discovery that we believe can be a game-changer. WP1096 and its close analog, WP1097, are structurally slightly different agents within the WP1122 portfolio. However, small structural changes unexpectedly resulted in high levels of antiviral activity and potentially a unique mode of action. The in vitro performance is significant enough that we simply must now consider proceeding with the necessary preclinical support for these additional molecules for antiviral clinical trials in addition to the lead molecule, WP1122."
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PEB | Hot Stocks07:36 EDT Pebblebrook Hotel has opened 1 additional urban hotel since August 17 - Since August 17, the Company has reopened 1 additional urban hotel, bringing its total number of open hotels and resorts to 35; these 35 properties accounted for approximately 71% of Pebblebrook's 2019 Hotel EBITDA
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KLDO | Hot Stocks07:35 EDT Kaleido Biosciences doses first patient in clinical study of KB295 - Kaleido Biosciences announced that the first patient has been dosed in its clinical study evaluating Microbiome Metabolic Therapy candidate KB295 in patients with mild-to-moderate ulcerative colitis. UC is an inflammatory bowel disease that can cause debilitating symptoms, including abdominal pain, bowel urgency and diarrhea. Evidence suggests that a feature of UC is alteration of the gut microbiome, including an increase in inflammatory bacteria and decrease in commensal diversity which interfere with the normal immune response. In ex vivo studies, KB295 has demonstrated the ability to increase the production of short chain fatty acids and suppress the growth of inflammatory bacteria such as Enterobacteriaceae. This non-IND/non-CTA open label, single arm clinical study is expected to enroll approximately 30 patients with mild-to-moderate UC. Patients will receive KB295 for eight weeks titrated up to 40 g twice daily and then enter a one-month follow-up period. The study will evaluate the safety and tolerability of KB295 and other assessments including the Simple Clinical Colitis Activity Index composite score, changes in microbiome composition and biomarkers of inflammation.
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ARCE | Hot Stocks07:34 EDT Arco Platform acquires Studos, terms not disclosed - Arco Platform announces it has acquired 100% of Studos Software, a technology provider for personalized student assessment, data-based academic performance diagnostics and AI-powered adaptive learning and test prep. Studos was founded in Santa Catarina state in 2013, with the objectives of increasing student performance at university entrance exams and reducing teacher workload. Studos supplies K-12 schools with content and tools that enable teachers to easily create and grade online and offline assessments, reducing assessment-related teacher workload by 80%. Studo's solution also analyses data on student performance and uses AI to provide adaptive learning paths focused on the individual needs of each student. On average, 50% of the 10 first-placed students in Santa Catarina Federal University's entrance exam used Studos for their test prep.
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PLSE | Hot Stocks07:33 EDT Pulse Biosciences receives MDSAP certification - Pulse Biosciences announced the receipt of Medical Device Single Audit Program, or MDSAP, certification. The Medical Device Single Audit Program allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system to satisfy the requirements of multiple regulatory jurisdictions or authorities to enable appropriate regulatory oversight of medical device manufacturers' quality management systems while minimizing regulatory burden on the industry. The program was developed by the International Medical Device Regulators Forum and currently representatives from The Therapeutic Goods Administration in Australia, Brazil's Agencia Nacional de Vigilancia Sanitaria, Health Canada; Canadian Medical Device Regulations, Japan's Ministry of Health, Labour and Welfare and Pharmaceutical and Medical Devices Agency and the FDA Center for Devices and Radiological Health participate in the program.
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WINT | Hot Stocks07:33 EDT Windtree's IND application for Phase 2 clinical study of KL4 approved by FDA - Windtree Therapeutics announced that FDA has accepted its Investigational New Drug, or IND, application for a Phase 2 clinical trial studying lyo lucinactant, its KL4 surfactant drug, in COVID-19 associated lung injury and acute respiratory distress syndrome, or ARDS, patients. Lucinactant is also used in the Company's drug and device combination development program called AEROSURF, being developed for treating preterm infants with Respiratory Distressed Syndromes. The SARS-CoV-2 virus causing COVID-19 uses the angiosten-converting enzyme 2, or ACE2, receptor for entry into host cells. ACE2 is a surface molecule on alveolar Type 2 cells in the lungs. The Type 2 cells are the source of surfactant production in the lung. Damage or loss of Type 2 cells and the viral pneumonia often associated with COVID-19 may result in impaired surfactant production leading to a loss of lung compliance and impaired gas exchange. The Company believes its synthetic KL4 surfactant may have the potential to mitigate surfactant deficiency and resist the widespread surfactant destruction that can occur as a result of COVID-19 associated lung injury. The initial study will evaluate changes in physiological parameters in COVID-19 patients who are intubated and mechanically ventilated for associated lung injury and ARDS.
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BBIO | Hot Stocks07:33 EDT BridgeBio, Origin Biosciences announce FDA acceptance of fosdenopterin NDA - BridgeBio Pharma and affiliate Origin Biosciences announced the US Food and Drug Administration has accepted its New Drug Application for fosdenopterin, a cyclic pyranopterin monophosphate substrate replacement therapy, for the treatment of patients with molybdenum cofactor deficiency Type A. The NDA has been granted Priority Review designation. Fosdenopterin has previously been granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation in the US and may be eligible for a priority review voucher if approved. It received Orphan Drug Designation in the US and Europe. This is BridgeBio's first NDA acceptance.
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MREO | Hot Stocks07:31 EDT Mereo BioPharma says discussions continuing for financing for acumapimod study - Acumapimod for Acute Exacerbations of Chronic Obstructive Pulmonary Disease: Discussions continuing on separate financing for the Phase 3 study agreed with the FDA and EMA
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DKS | Hot Stocks07:31 EDT Dick's Sporting takes actions to a future free of single-use plastic bags - Dick's Sporting announced two major actions to help create a future free of single-use plastic bags: a commitment to remove all single-use point-of-sale plastic bags from its stores by 2025 and a partnership with Closed Loop Partners' Center for the Circular Economy.
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MREO | Hot Stocks07:30 EDT Mereo BioPharma says partner discussions continuing for leflutrozole - Leflutrozole for hypogonadotropic hypogonadism: Partnering discussions continuing based on development in male infertility.
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MREO | Hot Stocks07:30 EDT Mereo BioPharma sees topline data from Phase 2 PoC study of alvelestat in 2H21 - Topline data from an ongoing Phase 2 proof of concept study remains on track for 2H 2021. Announced the initiation of a Phase 1b/2 placebo-controlled clinical trial to evaluate the safety and efficacy of alvelestat in hospitalized, adult patients with moderate to severe COVID-19 respiratory disease. Investigator-sponsored studies underway in AATD and in the orphan disease, bronchiolitis obliterans syndrome.
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MREO | Hot Stocks07:29 EDT Mereo BioPharma intends to partner setrusumab prior to conducting OI trial - Following regulatory discussions in 1H 2020, both the FDA and EMA have agreed on the principles of a design of a single Phase 3 pediatric pivotal study in OI. Intend to partner setrusumab prior to conducting a pivotal trial of setrusumab in children with severe OI. Partnering discussions are well underway with a range of potential structures including options for Mereo to retain commercial rights in certain regions.
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MREO | Hot Stocks07:28 EDT Mereo BioPharma on track to initiate Phase 1b/2 study of etigilimab in Q4 - On track to initiate a Phase 1b/2 study of etigilimab in combination with an anti-PD-1 in a range of solid tumor types in Q4 2020.
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MREO | Hot Stocks07:27 EDT Mereo BioPharma sees cash runway to early 2022 - Reports cash resources of GBP56.8M as of June 30.
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SMMT | Hot Stocks07:24 EDT Summit Therapeutics ceasing work on gonorrhea program - Based on results from recent preclinical studies, the DDS-01 series of antibiotics against Neisseria gonorrhoeae was determined not to have suitable qualities for further development as it had shown toxicity in animal studies and therefore, Summit is ceasing work on the gonorrhea program. The Company expects CARB-X will cover its remaining share of the work that has been funded under the award.
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SMMT | Hot Stocks07:24 EDT Summit withdraws commentary on timing of completion of Phase 3 Ri-CoDIFy trials - The company said, "Summit published data from its Phase 2 clinical trial of ridinilazole evaluating the effects of a narrow-spectrum or broad-spectrum antibiotic on intestinal bile acid profiles. This was the first study to demonstrate in humans the relationships between Clostridioides difficile antibiotic treatment choice and bile acid metabolism both during therapy and after treatment cessation. The results indicated that ridinilazole maintained an intestinal bile acid profile associated with a lowered risk of recurrence. The data were published in the American Journal of Physiology - Gastrointestinal and Liver Physiology. As of August 31, 2020, Summit had enrolled a total of 369 patients into its Phase 3 Ri-CoDIFy clinical trials of ridinilazole. Due to the uncertainties surrounding COVID-19, Summit is withdrawing public commentary on the timing of completion of the Phase 3 Ri-CoDIFy clinical trials. The Company plans to publicly update stakeholders quarterly as to enrollment status. The Ri-CoDIFy clinical trials aim to support application for marketing approval of the precision antibiotic ridinilazole in the United States and other territories and the goal of it being used as a first-line treatment for CDI by: testing for superiority over the current standard of care, vancomycin, in the primary endpoint of sustained clinical response at 30 days after treatment has ended; generating health economic data to support ridinilazole's commercial launch, when as and if approved by regulatory authorities; and undertaking microbiome and metabolome analysis that aims to show ridinilazole's impact on the gut microbiome and bile acids composition. BARDA is supporting the Phase 3 clinical trials and regulatory development of ridinilazole with a financial award of potential funding of up to $72.5M. As of June 30, 2020, an aggregate of $46.6M had been received."
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IRWD | Hot Stocks07:22 EDT Ironwood to discontinue IW-3718 development, reduce headcount by 35% - Ironwood announced that data from IW-3718-302, one of Ironwood's two identical Phase III trials evaluating IW-3718 in refractory gastroesophageal reflux disease, or GERD, did not meet the pre-specified criteria associated with a planned early efficacy assessment. Following the assessment from an independent data monitoring committee, Ironwood unblinded the data and confirmed that IW-3718-302 did not meet the criteria, including the study's primary endpoint of achieving a statistically significant improvement in heartburn severity. IW-3718 was generally well-tolerated in study IW-3718-302. Based on these findings, Ironwood plans to discontinue development of IW-3718, including stopping enrollment in IW-3718-301, the second Phase III trial. Ironwood plans to implement an organizational restructuring, reducing headcount by approximately 100 full-time employees, or nearly 35% of the current workforce. This is expected to affect both field-based and home-office employees, including the relevant general & administrative support functions. Following the changes, Ironwood expects to have approximately 210 full-time employees. The planned workforce reduction is anticipated to be substantially completed in Q1 of 2021. Ironwood expects these changes to result in total cost savings of greater than $95M, comprised of at least $45M in annualized cost savings related to the planned workforce reduction and an additional approximately $50M related to external spend for IW-3718 previously expected through 2021. Ironwood expects to incur one-time costs of approximately $10M-$12M in connection with discontinuing development of IW-3718, primarily associated with the planned reduction in workforce. Such costs are expected to be incurred primarily in Q4. As part of this workforce reduction and in light of recent changes in market dynamics related to the COVID-19 pandemic, Ironwood plans to restructure its commercial organization. Ironwood remains committed to seeking to maximize Linzess, and commercial efforts are being designed to focus primarily on gastroenterologists where Ironwood has strong, established relationships and a demonstrated ability to educate and impact treatment decisions.
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SMMT | Hot Stocks07:21 EDT Summit Therapeutics sees cash, cash equivalents sufficient through Jan. 31, 2021 - Cash and cash equivalents at June 30, 2020, of $36.4M compared to $63.8M at December 31, 2019. The Company's existing cash and cash equivalents and committed external funding are expected to be sufficient to enable the Company to fund its operating expenses and capital expenditure requirements through January 31, 2021. The Principal shareholder of the Company, Mr. Robert W. Duggan, has given his intention to the Board of Directors to participate in a future fundraise as required in order to support the Company with its clinical operations and planned research and development efforts.
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NOVS | Hot Stocks07:19 EDT AppHarvest, Novus Capital enter into definitive combination agreement - AppHarvest and Novus Capital Corp. announced a definitive agreement for a business combination that would result in AppHarvest becoming a public company. Upon closing of the transaction, the combined company will be named AppHarvest and is expected to remain listed on Nasdaq under a new ticker symbol. The combined company will be led by Jonathan Webb, AppHarvest's Founder & CEO. Upon the closing of the transaction, AppHarvest will retain its highly experienced management, a team of growers with over 140 years of agricultural experience, including 120 years of sustainable agriculture experience, a sustainability team with more than 40 years of experience; and construction managers who have successfully managed over $19B in projects. In addition, AppHarvest announced that Peter Halt has joined the executive team as CFO. Mr. Halt is a seasoned finance professional with several years of experience as a publicly traded company CFO, most recently having served as the CFO for TiVo Corporation. Investment highlights: Operates a 60-acre controlled environment agriculture facility in Morehead, KY - one of the largest high-tech greenhouses in the world - and has an active and robust development pipeline for future large-scale controlled environment indoor farm projects; First produce scheduled to be harvested, in early 2021, will be tomatoes, a crop that has seen imports rise to 60% of all fresh tomatoes available in U.S. stores; Designed to reduce water usage by 90% compared to traditional open-field agriculture and eliminate agricultural runoff; Aims to improve access to fresh non-GMO fruits and vegetables, as approximately 70% of the U.S. population is within a one-day drive of the Morehead, KY facility, which AppHarvest estimates will lower transportation costs compared to existing growers by up to 80%; Positioned to capitalize on the secular shift to plant-based foods, creating increased demand for locally grown, high-quality produce ; Long-term distribution agreement in place to reach top grocers in the United States. The business combination values AppHarvest at a $1B pro forma equity value, at the $10.00 per share PIPE price and assuming minimal redemptions by Novus Capital shareholders. The transaction will provide $475M of gross proceeds to the company, including $375M fully committed common stock PIPE at $10.00 per share anchored by existing and new investors - including Fidelity Management & Research Company, LLC, Inclusive Capital and Novus Capital Corporation. Assuming minimal redemptions, it is anticipated that this transaction provides AppHarvest over $435M of unrestricted cash at close, which will primarily be used to fund operations, including building additional high-tech controlled environment indoor farms, support growth and for other general corporate purposes. In addition, AppHarvest issued a $30M convertible note to Inclusive Capital which funded on September 28, 2020. The proceeds of the convertible note will primarily be used to fund operations, including development of new high-tech controlled environment indoor farms, during the period prior to the close of this transaction. This note will convert to shares of AppHarvest's common stock in connection with the close of this transaction. The Boards of Directors of each of Novus Capital and AppHarvest have unanimously approved the transaction. The transaction will require the approval of the stockholders of both Novus Capital and AppHarvest, and is subject to other customary closing conditions, including the receipt of certain regulatory approvals. The transaction is expected to close late in the fourth quarter of 2020 or early in the first quarter of 2021
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CNCE | Hot Stocks07:19 EDT Concert Pharmaceuticals completes patient enrollment in CTP-692 trial - Concert Pharmaceuticals announced that it has completed patient enrollment of its Phase 2 clinical trial to evaluate CTP-692 as an adjunctive treatment in patients with schizophrenia. Topline data from the trial are expected in Q1 of 2021.
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PZZA | Hot Stocks07:18 EDT Papa John's reports preliminary Q3 North America comparable sales up 23.8% - Reports preliminary Q3 domestic company-owned restaurants comparable sales up 18.2%. Reports preliminary Q3 system-wide international restaurants comparable sales up 20.5%. Of the company's approximately 2,100 international franchised stores, approximately 90 are temporarily closed, primarily in Latin America and Europe, in accordance with government policies. In North America, almost all traditional restaurants remain open and fully operational. A number of non-traditional restaurants located in universities and stadiums are temporarily closed; these non-traditional locations are not material to the company's revenues and operating results.
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BIG | Hot Stocks07:15 EDT Big Lots jumps 6% to $50.50 after Q3 guidance exceeds estimates
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MMC | Hot Stocks07:14 EDT Marsh & McLennan CHRO Laurie Ledford, CIO Scott Gilbert to retire - Marsh & McLennan announced two leadership appointments. Effective January 1, Carmen Fernandez will be senior VP and chief human resources officer, or CHRO, and Paul Beswick will be senior VP and chief information officer, or CIO. In their new roles, Fernandez and Beswick will report to Marsh & McLennan president and CEO Dan Glaser and join the company's executive committee. They succeed Laurie Ledford and Scott Gilbert, who have served their roles as CHRO and CIO and will retire from the company at the end of the year. Over her 15-year career at Marsh & McLennan, Fernandez has served as CHRO of Guy Carpenter and held various HR leadership roles at Mercer, including North America HR leader and global HR Leader for the career business. As Marsh & McLennan's Deputy CHRO, she has been leading initiatives that align and strengthen the Company's HR capabilities for all colleagues. Beswick worked at Oliver Wyman for over two decades, partnering with clients in a range of sectors on strategic, operational and technology issues. He also founded and led the business's digital practice, with a focus on agile development, data analytics and technical innovation.
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AXSM HTGC | Hot Stocks07:14 EDT Axsome Therapeutics announces $225M term loan facility with Hercules Capital - Axsome Therapeutics (AXSM) has secured a $225M term loan facility with Hercules Capital (HTGC). The committed capital strengthens the Company's balance sheet through the anticipated commercial launches of its two lead product candidates, AXS-05 for major depressive disorder and AXS-07 for migraine, and extends its cash runway into at least 2024, based on current operating plans. Under the terms of the new $225M term loan facility, $60M may be drawn at closing; $115M may be drawn at the Company's option, in three separate tranches, upon approval of AXS-05 in MDD, upon approval of AXS-07 in migraine, and upon certain combined sales criteria for AXS-05 and AXS-07; and an additional $50M is available, subject to the approval of Hercules Capital, to support future strategic initiatives, including further pipeline advancement or expansion. Of the initial $60M, the Company drew down $50M at closing, with the additional $10M available to be drawn at the Company's option. A portion of the initial drawdown was used to repay the Company's previously existing $20M principal loan with Silicon Valley Bank along with associated final payment fees. The new term loan facility bears interest at a calculated prime-based variable rate currently at 9.15%. It matures in October 2025 and has an initial interest-only payment period of 30 months, which may be extended to up to 48 months upon the drawing of future tranches. Axsome will issue warrants to purchase 15,541 shares of Axsome common stock upon initial funding of the facility.
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ALEAF | Hot Stocks07:12 EDT Aleafia Health launches Cannabis 2.0 portfolio with 510 vape cartridges - Aleafia Health announced the launch and release of 510 vape cartridges which represent the Company's first Cannabis 2.0 product format in market. The company said highlights include, "510 Vape Cartridges: Sold under the Symbl adult-use and Emblem medical brands, the vapes are inspired by Aleafia Health's signature cultivars. The custom-made, unique terpene blends deliver robust flavours and consistent effects. They contain CO2-extracted distillate mixed with a custom blend of botanically sourced terpenes. No fillers or artificial flavours are used, offering consumers and patients an authentic experience. Sublingual Strips: Full production and packaging of the first production lot of cannabis-infused sublingual strips is underway, with a near-term launch expected. Featuring a rapid onset time and novel form factor, the sublingual strips offer patients and consumers a discreet, consistent experience. Confectionary Edibles: Initial production of confectionary edibles has also begun at the Company's Paris Facility following extensive research & development. They represent a major growth format with limited availability in Canada to date. Expanded Dried Flower Offering: Expanding upon its signature strains, the Company has acquired a roster of new cultivars that are now in production at the Niagara Facility. Leveraging the greater scale of cultivation at Niagara, the Company will begin introducing a broader assortment of dried flower SKUs to align with the demand of key consumer segments."
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USEG | Hot Stocks07:10 EDT U.S. Energy to acquire upstream assets in New Mexico, Wyoming for $500,000 - U.S. Energy announced that the Company has entered into an Asset Purchase Agreement and closed a transaction to acquire operated and non-operated producing assets primarily located in Lea County, New Mexico and Converse County, Wyoming. The acquired Properties consist of select upstream assets of FieldPoint Petroleum Corporation and were acquired pursuant to Fieldpoint's Chapter 7 bankruptcy process. Acquisition Highlights: Proved Developed Producing reserves estimated at approximately 237,263 barrels of oil equivalent. PDP PV-10 estimated at $2.5M Lea County, New Mexico assets comprise approximately 82% of total PDP volumes. Converse County, Wyoming assets comprise approximately 15% of total PDP volumes. Assets acquired for $500,000 in cash. As of August 1, 2020, the Properties had total estimated proved reserves of approximately 237,263 Boe, all of which are Proved Developed Producing reserves, and had a present value of estimated future net revenues before income taxes discounted at 10% value of approximately $2.5less than. The properties are 59% non-operated and 41% operated, with the non-operated assets being operated primarily by Cimarex Energy and ConocoPhillips in Lea County, New Mexico. The consideration paid at closing by U.S. Energy consisted of $500,000 in cash.
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JCOM | Hot Stocks07:10 EDT j2 Global to acquire RetailMeNot for $420M from Vericast - J2 Global announced that it has entered into a purchase agreement to acquire RetailMeNot for approximately $420M from Vericast, a marketing solutions company. The transaction, subject to customary closing conditions and regulatory approvals, is expected to close in Q4. Upon completion of the transaction, J2 Global expects to provide an update on the estimated financial contribution of the acquisition.
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SOGO SOHU | Hot Stocks07:10 EDT Sogou announces merger plan with Tencent - Sogou (SOGO) announced that it has entered into a definitive Agreement and Plan of Merger with THL A21, TitanSupernova, and Tencent Mobility, collectively, the Tencent Parties, each of which is a direct or indirect wholly-owned subsidiary of Tencent Holdings, pursuant to which Parent will be merged with and into the Company in an all-cash transaction, and the Company will become an indirect wholly-owned subsidiary of Tencent. Upon the effectiveness of the Merger, outstanding Class A ordinary shares of the Company, including Class A Ordinary Shares represented by American depositary shares, other than Excluded Shares and ADSs representing Excluded Shares, will be cancelled in exchange for the right for the holders thereof to receive $9.00 in cash per share or ADS. The Merger Consideration represents a premium of approximately 56.5% to the closing trading price of the ADSs on July 24. On or about the same time as the Company entered into the Merger Agreement, Sohu.com (SOHU). Also on or about the same time, THL and Parent entered into a contribution agreement, pursuant to which THL has agreed to contribute all of the Class B Ordinary Shares of the Company owned by it to Parent. The Merger is currently expected to close in the Q4. If completed, the Merger will result in the Company becoming a privately-held indirect wholly-owned subsidiary of Tencent, the Company's ADSs will no longer be listed on the New York Stock Exchange, and the ADS program will be terminated. Duff & Phelps is serving as independent financial advisor to the Special Committee and Goulston & Storrs PC is serving as U.S. legal counsel to the Special Committee. The validity of the Merger and certain other legal matters with respect to Cayman Islands law are being passed upon and advised for the Company by Conyers Dill & Pearman. Goldman Sachs is serving as financial advisor to the Tencent Parties and Davis Polk & Wardwell is serving as U.S. legal counsel to the Tencent Parties.
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CASI | Hot Stocks07:09 EDT Casi Pharmaceuticals restructures partnership with Juventas Cell Therapy - CASI Pharmaceuticals announced a restructuring of its partnership with Juventas Cell Therapy Ltd. relating to CNCT19, an investigational CD19 CAR-T Cell therapy. Juventas is currently developing CNCT19 for the treatment of patients with relapsed B-cell Non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia, and expects to initiate registration trials in early 2021. Under the terms of the original licensing agreement between CASI and Juventas, CASI obtained a worldwide license for the commercialization of CNCT19 and Juventas was responsible for the clinical development, manufacturing and supply of CNCT19. As part of the original agreement, CASI Biopharmaceuticals invested in Juventas' Series A financing. The original agreement also provided that CASI would be responsible for payment of certain sales royalties and a development milestone in the amount of RMB 70M upon the initiation of the registration trials. Effective as of September 22, Juventas and its shareholders agreed to certain terms and conditions in connection with Juventas' Series B financing. In order to facilitate the Series B financing, CASI agreed to restructure its partnership with Juventas by amending and supplementing its original licensing agreement. Under the Supplementary Agreement, CASI and Juventas will partner to co-commercialize CNCT19 and jointly be responsible for forming an integrated marketing team to carry out marketing activities, and CASI will continue to be responsible for recruiting and establishing a sales team to commercialize CNCT19. In addition, the Supplementary Agreement provides CASI with co-commercial rights to a second pipeline product from Juventas, subject to certain terms and conditions. As part of this transaction, Juventas will waive the RMB 70M milestone payment due from CASI in connection with the upcoming start of registration trials for CNCT19. CASI and Juventas will share a percentage of total net profits, with CASI receiving a tiered percentage of up to 50% of the net profit from commercial sales of CNCT19 depending on annual net sales, with a specified minimum annual target net profit to be distributed to Juventas as a percentage of net profit from commercial sales. In addition, CASI will be responsible for single digit royalty fee equal to a percentage of net sales that varies by region. As part of this transaction, CASI Wuxi Bio will invest RMB 70M in Juventas' Series A Plus equity, resulting in equity ownership of approximately 19.65% and entitling it to appoint a director to the Juventas' board of directors.
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NXST | Hot Stocks07:08 EDT Nexstar promotes Thomas Carter to COO - Nexstar announced that Thomas Carter has been named president and COO, effective October 1. Carter will retain his current responsibilities as CFO for the foreseeable future. In conjunction with his promotion, Carter has entered into a new employment agreement that extends through December 31, 2023. Carter joined Nexstar as CFO in August 2009 and has played a role in the execution of the company's growth plan through the completion and integration of acquisitions, including Tribune Media Company and Media General, which have resulted in a expansion of Nexstar's free cash flow and operating portfolio. He has also led integration planning and post-transaction synergy realization teams as well as continuous capital structure improvements, ongoing cost of capital reduction, operational efficiency enhancements and return of capital initiatives.
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NBEV | Hot Stocks07:07 EDT NewAge completes divestment of 'Brands Within Reach' group - NewAge announced that is has signed and closed a definitive agreement with Zachert Private Equity to sell its 'Brands Within Reach' group and associated retail brands effectively immediately. The divestiture includes sales of the membership interests and assets of NewAge's subsidiary, Brands Within Reach, including the licensed brands Nestea, Volvic, Evian, Illy, Kusmi Tea, Saint Geron and various other retail brands, including Xing, Bucha Live Kombucha, Aspen Pure and CoCo Libre. On July 20, 2020, NewAge, Inc., announced the signing of a definitive agreement to acquire ARIIX and four other e-commerce/direct selling companies. The combination is expected to create a company with expected annual revenues of more than $500M, a blended gross margin of 70%, and expected EBITDA of more than $30M.
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DHR | Hot Stocks07:06 EDT Danaher's Cepheid receives FDA EUA for Xpert Xpress SARS-CoV-2/Flu/RSV - Cepheid announced it has received Emergency Use Authorization from the U.S. FDA for Xpert Xpress SARS-CoV-2/Flu/RSV, a rapid molecular diagnostic test for qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample. The four-in-one test is designed for use on any of Cepheid's over 26,000 GeneXpert Systems placed worldwide, with results delivered in approximately 36 minutes. The new EUA combination test is expected to begin shipping to US customers this week, with expected CE-IVD availability in November.
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NUPMF | Hot Stocks07:06 EDT New Pacific extends areas of silver mineralization at Silverstrike Project - New Pacific Metals is pleased to provide an update on its exploration activities at its Silverstrike Project, Bolivia. New Pacific acquired a 98% interest in the Project in December 2019. Reconnaissance and detailed mapping and sampling programs have been completed on the northern portion of the Project. The results to date indicate good to excellent exploration potential for hosting narrow high-grade and near-surface broad-zones of silver mineralization. Silverstrike North is centred on the historic Berenguela Mining District and is characterized by abundant historic mine adits, declines, shafts and spoil heaps scattered intermittently over an approximately 3.5 by 2.2 km area. It includes the Valley Zone, North Top, Tarafaya Mine, South Top, West Top, and CP Zone in addition to the former San Luis Mine, Lourdes Ines Mine and the Turini Mine which are discussed below. In March 2020, the Company initiated an integrated exploration program consisting of 1:5000 scale reconnaissance and 1:500 scale detailed geological, structural and alteration mapping and geochemical sampling programs. The program aimed to geologically define and sample the extents of the hydrothermal system(s), including extensive Spanish Colonial-era historic workings to develop drill targets. The exploration team identified and sampled numerous mining adits, declines, shafts and surface open pits. Historic mining operations were developed along steeply dipping fracture zones which ranged from 0.5-2 meters wide developed in altered / bleached Tertiary aged sandstones. In addition, several new mineralized zones were identified as part of the field work. A total of 2,751 samples were collected including 2,607 channel chip samples and 144 mine dump grab samples. Majority of the samples were taken from surface outcrops of alteration and mineralization. All 2,751 assay results have been received of which, 56 samples have silver grades greater than300 g/t, 163 samples with greater than100 g/t, and 236 samples greater than50 g/t. Representative channel chip samples were collected perpendicular to outcropping altered fractures, however, in many areas historic mining activities and resultant waste dumps obscure the facture zones. Underground channel chip sampling across mineralized zones typically returned grades ranging from a few hundred to more than one thousand ppm Ag and associated base metals. New Pacific's exploration team is currently completing mapping and sampling of the Silverstrike Central and South areas summary results of which will be released upon receipt. Following integration of the geochemical sample results and geological data, the Company will generate drill targets for testing upon receipt of required drill permits which is tentatively anticipated in Q4 2020.
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TGT | Hot Stocks07:04 EDT Target announces Target Deal Days on October 13, 14 - Target announced the return of Target Deal Days on Oct. 13 and 14, kicking off a holiday season that will feature nearly 1M more deals than last year, Black Friday pricing all November long and an extended Price Match Guarantee. "This year, in a holiday season unlike any other, we know it's more important than ever for our guests to get great deals in a convenient and safe shopping environment," said Christina Hennington, executive vice president and chief merchandising officer, Target. "By kicking off our holiday deals earlier than ever, offering Black Friday pricing throughout the full month of November and extending our Price Match Guarantee, we're letting guests know they don't need to wait or face the crowds to get the best deals, all with no membership fees required."
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UHS | Hot Stocks07:03 EDT Universal Health announces information technology security incident - Universal Health Services experienced an information technology security incident in the early morning hours of September 27. As a result, the company suspended user access to its information technology applications related to operations located in the United States. The company has implemented extensive information technology security protocols and is working diligently with its security partners to restore its information technology operations as quickly as possible. In the meantime, while this matter may result in temporary disruptions to certain aspects of our clinical and financial operations, our acute care and behavioral health facilities are utilizing their established back-up processes including offline documentation methods. Patient care continues to be delivered safely and effectively. "At this time, we have no evidence that patient or employee data was accessed, copied or misused."
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IMTX IFRX | Hot Stocks07:02 EDT Immatics appoints Arnd Christ as CFO - Immatics (IMTX) announced that Arnd Christ will join its leadership team as CFO as of October 1, 2020. Arnd Christ was previously the CFO of InflaRx (IFRX). Immatics' current CFO, Thomas Ulmer, is stepping down to pursue new opportunities.
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XLRN BMY | Hot Stocks07:01 EDT Acceleron, Bristol-Myers announce Health Canada approval of REBLOZYL - Bristol Myers Squibb Canada (BMY) and Acceleron Pharma (XLRN) announced that Health Canada has approved REBLOZYL for the treatment of adult patients with red blood cell transfusion-dependent anemia associated with beta(beta)-thalassemia.1 REBLOZYL is the first and only erythroid maturation agent in Canada, representing a new class of treatment for eligible patients.
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GFL | Hot Stocks06:59 EDT GFL Environmental receives DOJ approval for WCA Waste acquisition - GFL Environmental announced that the U.S. Department of Justice, or DOJ, has approved the company's proposed acquisition of WCA Waste, or WCA, under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. As previously announced, on August 12, GFL entered into a definitive agreement with an affiliate of Macquarie Infrastructure Partners II to purchase WCA and its subsidiaries for an aggregate purchase price of $1.21B. With the receipt of DOJ approval, one of the conditions to the closing of the acquisition, the parties expect to close the acquisition on October 1.
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LH | Hot Stocks06:59 EDT LabCorp and Infirmary announce collaboration - LabCorp and Infirmary Health, the largest non-governmental health care system in Alabama, announced that they have entered into a multi-year collaboration to provide laboratory services to patients and providers throughout the eastern Gulf Coast region. LabCorp, which has a long-standing presence in Alabama through laboratory facilities in Birmingham, will provide lab management, phlebotomy and logistics services, and reference testing to Infirmary Health. Infirmary Health recently underwent a complete laboratory transformation so it could fully utilize LabCorp services. The process, which was complicated by the global pandemic, required unprecedented coordination to maintain safety and quality.
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SAH | Hot Stocks06:57 EDT Sonic Automotive acquires four acres of land adjacent to EchoPark - Sonic Automotive announced it has purchased approximately four acres of land directly adjacent to the Company's Charlotte, North Carolina, EchoPark retail hub location. The expanded property will accommodate approximately 400 additional inventory parking spaces, bringing the total inventory capacity at the Charlotte EchoPark retail hub location to approximately 1,000 vehicles. Located at 3648 East Independence Boulevard, the Charlotte, North Carolina, EchoPark store opened in October 2018, one of the Company's earliest EchoPark locations, with approximately 1,500 vehicle sales in the Q2. Overall, EchoPark saw retail used vehicle sales volume of 13,207 units in the Q2and is on pace to retail over 61,000 pre-owned vehicles in 2020.
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ACST | Hot Stocks06:56 EDT Acasti Pharma announces review of strategic alternatives - Acasti Pharma announces the company has commenced a formal process to explore and evaluate strategic alternatives to enhance shareholder value. Towards this end, the company has engaged Oppenheimer & Co. as its financial advisor to assist in the process. There can be no assurance of a successful outcome from these efforts, or of the form or timing of any such outcome. The company does not intend to make any further disclosures regarding the strategic review process unless and until a specific course of action is approved by the Company's Board of Directors. In the meantime, the company and its clinical advisors plan to complete the full data analyses as contemplated in the Statistical Analysis Plan for TRILOGY 2, including the secondary and exploratory endpoints, and the pooling of the data from TRILOGY 1 and 2.
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NI | Hot Stocks06:50 EDT NiSource provides growth strategy update at virtual investor day - NiSource has nearly $14B of regulated rate base, following the sale of CMA. NiSource's core business strategy is expected to drive long-term revenue and dividend growth, supported by stable, rate base driven revenue streams and approximately $40B in expected infrastructure investment opportunities over 20 years. These investment opportunities represent an increase of $10B over prior expectations, driven by incremental investments in renewable generation and safety and asset modernization enhancements across both gas and electric operations which total $9.9B-$10.5B of capital investment opportunities during the 2021 - 2024 plan period. At investor day, NiSource will discuss its recently launched NiSource Next initiative, a program designed to identify long-term, sustainable capability enhancements and cost efficiency improvements. Through this program, the company anticipates driving continuous operational learnings and improvements throughout the organization, while also contributing to an approximately 8% reduction in O&M costs in 2021 from expected 2020 levels. This cost reduction is expected to offset future inflationary pressure to keep O&M costs relatively flat through 2024 and ensure customers realize the value of the company's enhanced capabilities. Execution of NiSource's strategy is expected to drive a rate base compound annual growth rate, or CAGR, of 10%-12%, which is expected to result in a 7%-9% NOEPS CAGR, and annual dividend growth to maintain the company's targeted 60%-70% payout ratio over 2021-2024. NiSource continues to execute its renewable generation transition strategy that embraces the need for clean energy in supporting its customers and communities through its NIPSCO gas and electric distribution company in Indiana. The company is focused on retiring 100% of coal generation assets by 2028 and replacing them primarily with renewables. As part of NIPSCO's planned replacement of approximately 1,400 megawatts of retiring coal-fired generation in 2023, NiSource has identified $1.8B- $2B in capital investment opportunities, incremental to our previous capital plan, to be deployed primarily across 2022 and 2023. These investments in renewable energy will provide benefits for customers and value for shareholders. The overall replacement plan is expected to save NIPSCO's electric customers more than $4B in costs over 30 years when compared to the continued operation of NIPSCO's current generation fleet and to reduce greenhouse gas emissions 90% by 2030 compared to a 2005 baseline.
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APM | Hot Stocks06:47 EDT Aptorum Group launches infectious disease liquid biopsy subsidiary - Aptorum Group Limited announced its launch of Aptorum Innovations - an infectious disease liquid biopsy diagnostics subsidiary and its newly established exclusive in-licensing arrangements with Accelerate Technologies Pte Ltd, commercialization arm of the Singapore's Agency for Science, Technology and Research, to co-develop novel molecular-based rapid pathogen identification and detection diagnostics technology. Aptorum Innovations, intends to target the global molecular diagnostics market estimated to reach $13.8B in market size by 2025, of which 60% is estimated to be attributable to the infectious disease segment, with its next-generation RPIDD technology. Aptorum Innovations Pte Ltd is the exclusive licensee and commercializing party of the technology being developed in close cooperation with A*STAR and licensed by Accelerate Technologies. Subject to further validation and optimization of the RPIDD technology, Aptorum Group intends to open its initial series of RPIDD-driven infectious disease liquid biopsy diagnostics laboratories over the course of the next two years, with at least one flagship location in Singapore in collaboration with local hospitals and clinics; other targeted follow-on locations include the United States, European Union and the United Kingdom. Through A*STAR, the technology is currently undergoing product optimization at its Diagnostics Development Hub and A*STAR will continue to perform further clinical validation with Singapore based hospital provider; Aptorum Innovations will facilitate further clinical validation with other locations including but not limited to Australia-based Talem Medical Group, Raffles Medical Group and other future collaboration potentials.
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ANVS | Hot Stocks06:46 EDT Annovis Bio announces publication of peer-reviewed data on Posiphen - Annovis Bio announced the publication of peer-reviewed data demonstrating the ability of its lead candidate, ANVS401, also known as Posiphen, to improve axonal transport, the information highway of nerve cells. The publication, "Targeting increased levels of APP in Down syndrome: Posiphen-mediated reductions in APP and its products reverse endosomal phenotypes in the Ts65Dn mouse model," was published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association. The study was conducted at the University of California San Diego's Department of Neurosciences in Dr. William Mobley's lab at UCSD. Professor Mobley, MD, PhD..
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LXRP | Hot Stocks06:45 EDT Lexaria Bioscience provides research initiative update, introduces new project - Lexaria Bioscience provided an update on a previously announced antiviral research initiative and introduces a new research project with potential COVID-19 applications. On March 19, Lexaria announced that it planned to conduct a pilot human pharmacokinetic exploratory study in healthy volunteers of antiviral drugs that have previously been studied against other coronavirus strains, comparing Lexaria's DehydraTECH formulations to controls without Lexaria's technology. The ethics board approval required as a first step in this pilot study has now been received, conditional on further government regulatory approval also being granted. Lexaria will now begin the process of pursuing the necessary steps to file for approval from federal regulators. In parallel with this, Lexaria is also announcing the launch of a separate rodent antiviral study to evaluate pharmacokinetic benefits from the use of DehydraTECH in the delivery of representative drugs from two classes of antiviral drugs heavily under investigation against COVID-19. The drugs to be used have already been processed with DehydraTECH and sent to the testing facility. Dosing of the rodents has already begun and study results are expected in December.
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MKC | Hot Stocks06:36 EDT McCormick announces 2-for-1 stock split - The company announced a 2-for-1 stock split of the company's common stock and common stock non-voting shares. The additional shares will be distributed on November 30 to stockholders of record as of November 20. The split will double the number of outstanding common and common non-voting shares. Common and common non-voting shares and per-share data in this press release have not been adjusted for the impact of the split. We expect trading will begin on a split-adjusted basis on December 1.
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AERI | Hot Stocks06:33 EDT Aerie announces positive review of IND from FDA for AR-15512 eye drop - Aerie Pharmaceuticals announced that the FDA has reviewed the Investigational New Drug Application, or IND, for AR-15512, or TRPM8 agonist, eye drop for dry eye and it is now in effect, allowing Aerie to initiate clinical studies in the treatment of dry eye. Aerie expects to initiate a Phase 2b clinical study in the Q4. AR-15512, formerly AVX-012, was acquired by Aerie in November 2019 in the acquisition of Avizorex Pharma, a Spanish ophthalmic pharmaceutical company developing therapeutics for the treatment of dry eye disease. The active ingredient in AR-15512 is a potent and selective agonist of the TRPM8 cold thermoreceptor ion channel that regulates tear production and blink rate. "The acceptance of the IND for AR-15512 marks the first clinical-stage dry eye product candidate for Aerie, another important milestone for the company. We expect to commence a Phase 2b clinical study, which will be powered as a Phase 3, later this year, with a topline readout expected in the Q3 of FY21," said Vicente Anido, Jr., Ph.D., Chairman and CEO.
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TIF LVMUY | Hot Stocks06:33 EDT Tiffany responds to 'baseless and misleading' counterclaims filed by LVMH - Tiffany & Co. (TIF) responded to baseless and misleading counterclaims finally filed yesterday by LVMH (LVMH) in Delaware Chancery Court -- 18 days after LVMH said it intended to assert claims. Chairman of the Board Roger Farah said, "LVMH's specious arguments are yet another blatant attempt to evade its contractual obligation to pay the agreed-upon price for Tiffany. Tiffany has acted in full compliance with the Merger Agreement, and we are confident the Court will agree at trial and require specific performance by LVMH. Had LVMH actually believed the allegations made in its complaint, there would have been no need for LVMH to procure the letter from the French Foreign Minister as an excuse for its refusal to close." CEO Alessandro Bogliolo said, "I am so proud of how Tiffany has gone above and beyond during the pandemic to deliver our brand mission and keep delighting our customers, even in the most uncertain of times. I want to thank the entire Tiffany team for their continued professionalism and dedication in the face of baseless accusations and misinformation." LVMH also criticizes Tiffany for closing its stores in Arizona, Florida and Texas "five days to over two weeks" before the closures were mandated by law in those states. LVMH cannot show that the steps Tiffany took to protect the health and welfare of its employees and customers during the pandemic violated the Merger Agreement. Tiffany took swift action around the world to protect the safety of its stakeholders during the pandemic, and those actions were entirely consistent with its legal obligations, its Code of Business and Ethical Conduct, and its brand and corporate identity. The fact that LVMH felt compelled to even suggest that Tiffany's decision to close a limited number of stores "five days to over two weeks" early in order to protect employees and customers provides adequate grounds to walk away from its contractual obligations underscores the obvious weakness of its case.
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OSTK | Hot Stocks06:31 EDT Utah District Court rules in favor of Overstock in Class Action securities case - Overstock.com announced that the United States District Court for the District of Utah ruled in favor of Overstock in a 27-page memorandum decision and order dismissing the securities class action case filed against the company, Patrick Byrne, Greg Iverson, and Dave Nielsen in September 2019. Overstock and other defendants filed motions to dismiss with the district court and argued that the complaint filed against them by the Mangrove Partners Fund, LTD, should be dismissed in its entirety. The district court agreed.
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WBAI | Hot Stocks06:29 EDT 500.com says auditor resigned, old financial statements should not be relied on - 500.com Limited announced that Friedman LLP has resigned as its auditor on September 23, 2020; and the company appointed MaloneBailey, LLP on September 27, 2020 to conduct an audit of the company's consolidated financial statements and effectiveness of its internal controls over financial reporting for the fiscal year ended December 31, 2019, and to re-audit the company's consolidated financial statements and effectiveness of its internal control over financial reporting for each of the fiscal years ended December 31, 2017 and 2018. Pursuant to the company's articles of association, the decision to appoint a new auditor was unanimously approved by the directors of the company, including all members of the Company's Audit Committee, on September 27, 2020. "Friedman has elected to resign as the auditors of the company because of the disagreement with the management of the company on the effectiveness of the company's internal control over financial reporting in light of certain alleged unlawful payments by three former consultants while they were engaged by the company in connection with the potential development of an integrated casino resort project in Japan. The company is not involved in any legal proceeding in Japan but has treated the allegations seriously. As announced by the company in its December 31, 2019 and January 16, 2020 press releases furnished to the SEC on Form 6-K, the Special Investigation Committee of the Company's Board of Directors engaged King & Wood Mallesons to investigate the money transfers and the related conduct of the company's Japanese consultants. KWM has completed a substantial portion of its investigation, and presented a preliminary review to the SIC. To date, the SIC, after considering KWM's findings, did not identify any violation of the US Foreign Corrupt Practices Act of 1977 by the company in connection with the payments or the company's prior activities in Japan, which view has been shared with Friedman. The SIC is also in the process of reviewing the company's compliance policies, procedures and internal controls based on the recommendations from KWM, and the company has updated and will continue to enhance its policies, procedures and internal controls as appropriate. Regardless, Friedman determined that the payments may have reflected material weakness in relation to internal controls of the company. Friedman further advised us on September 23, 2020 that because some of the payments had occurred in 2017 and 2018, the allegedly unlawful purpose of which was not known to Friedman at the date of the audit reports relating to the company's consolidated financial statements for the years ended December 31, 2017 and 2018. Accordingly, the integrated audit reports issued by Friedman on the company's consolidated financial statements for fiscal years ended December 31, 2017 and 2018 should no longer be relied upon. The company's Audit Committee has discussed the issue with Friedman, and it does not agree with Freidman's conclusion. The Audit Committee is not aware of any information suggesting that the relevant audit reports are inaccurate or misleading. Friedman's audit reports on the company's consolidated financial statements for each of the fiscal years ended December 31, 2017 and 2018 do not contain an adverse opinion or a disclaimer of opinion, or was qualified or modified as to uncertainty, audit scope, or accounting principles. During Friedman's term as the company's independent auditors, except for the above-mentioned disagreement, Friedman did not have any other disagreements on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements, if not resolved to the satisfaction of Friedman, would have caused Friedman to make reference to the subject matter of the disagreements in connection with its audit reports. During each of the fiscal years ended December 31, 2017 and 2018, there have been no other reportable events requiring disclosures, as defined in Item 16F(a)(1)(v) of Form 20-F. The company provided a copy of the above statements contained in the first, second and fourth paragraphs to Friedman and requested that Friedman furnish a letter addressed to the SEC stating whether it agrees with the above statements, and if not, stating the respects in which it does not agree," 500.com stated. The company will closely work with MaloneBailey to complete the audit and review process as soon as possible, 500.com added.
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BEDU | Hot Stocks06:17 EDT Bright Scholar to acquire 60% equity interests in Leti Camp - Bright Scholar announced that it entered into agreements to acquire 60% equity interests in Leti Camp. The company targets to complete the transaction in November, subject to the satisfaction of customary closing conditions and the completion of relevant corporate and regulatory procedures. Established in 2017, Leti Camp specializes in providing summer and winter camp activities for teenagers and owns a product offering in hands-on inquiry based learning, or HIBL, and camp business. Leti Camp has served around 100,000 students across China with services well received by its partner schools and educational institutions.
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INFO | Hot Stocks06:07 EDT IHS Markit says 'exiting the year in good position to achieve our 2021 outlook' - "In Q3, we delivered solid results as the markets we operate in have begun to recover at varying speeds. We are managing the COVID challenges well while continuing to make the right long-term decisions for the company, shareholders, and the communities that we operate in and serve," said Lance Uggla, chairman and CEO at IHS Markit. "We are positioned to deliver results for the year that include recurring organic revenue growth, strong margin expansion, and double-digit normalized earnings growth and are exiting the year in good position to achieve our 2021 outlook," said Jonathan Gear, CFO at IHS Markit.
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MSFT | Hot Stocks06:06 EDT Microsoft Outlook, Office 365, Teams back for most users following outage - Some Microsoft services, including Outlook, Office 365, and Microsoft Teams, experienced a multi-hour outage on Monday, but they should be back for most users, according to the company. "We have confirmed via our monitoring that the majority of services have recovered for most customers," reads a notice on Microsoft's Office status page. "However, we continue to see a small subset of customers whose tenants are located in North America region who are still impacted. We're now investigating mitigation steps for those customers who are still affected." Reference Link
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INFO | Hot Stocks06:06 EDT IHS Markit reports Q3 cash flow from operations of $403M, free cash flow $339M
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ORCL ZM | Hot Stocks06:06 EDT Oracle, Zoom Video announce integrations for customer experience - Oracle (ORCL) announced new integrations between Oracle fusion cloud customer experience, or CX, and Zoom (ZM) that will help sales, marketing, and customer service teams incorporate video into existing processes and workflows. To support the rapid growth in digital selling, marketing, and customer service, Oracle and Zoom are introducing a series of integrations between Zoom's communications platform and Oracle Cloud CX applications.
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RDWR | Hot Stocks06:05 EDT Radware, Bharti Airtel announce partnership - Radware and Bharti Airtel, India's largest integrated telco, announced a partnership under which Airtel will offer Radware's Cloud DDoS Protection, Cloud WAF, and Bot Manager cloud security services to enterprise customers. As part of the agreement, traffic from Airtel's customers will be secured via a new India-based scrubbing service center, which is hosted by Airtel's Nxtra Data.
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MOH | Hot Stocks06:04 EDT Molina Healthcare to acquire Affinity Health Plan for $380M - Molina Healthcare announced that it has entered into a definitive agreement to acquire substantially all of the assets of Affinity Health Plan. The purchase price for the transaction is approximately $380M, net of expected tax benefits and inclusive of an amount representing Molina's target allocation of required regulatory capital. Molina intends to fund the purchase with cash on hand. Affinity is a Medicaid managed care organization serving members in New York City, Westchester, Orange, Nassau, Suffolk, and Rockland counties in New York. It has a 35 year history of supporting Medicaid managed care populations. As of August 31 Affinity served approximately 284,000 Medicaid members. Affinity's premium revenue for the trailing twelve months ended July 31, was approximately $1.3B. The net purchase price of approximately $380M represents less than 30% of premium revenues for the twelve months ended July 31 and the transaction is expected to be immediately accretive to adjusted earnings per share. The transaction is subject to receipt of applicable federal and state regulatory approvals, and satisfaction of other customary closing conditions. It is expected to close in the Q2 of FY21.
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PRSC | Hot Stocks06:03 EDT Providence Service to acquire Simplura Health Group for $575M in cash - Providence Service announced that the company has entered into a definitive agreement to acquire Simplura Health Group, which operates a large network of home health and personal care agencies across seven states, from One Equity Partners in an all cash transaction at an enterprise value of $575M. The transaction is expected to be immediately accretive to adjusted EPS before synergies and is expected to close in the fourth quarter.
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TIF LVMUY | Hot Stocks05:49 EDT LVMH files countersuit against Tiffany, says conditions not met to close deal - LVMH (LVMUY) said it filed yesterday its countersuit against Tiffany (TIF) in Delaware Chancery Court. "LVMH continues to have full confidence in its position that the conditions necessary to close the acquisition of Tiffany have not been met and that the spurious arguments put forward by Tiffany are completely unfounded," the company said in a statement. LVMH's position is that a "Material Adverse Effect has occurred." The company added, "The notable absence of a pandemic carveout in the definition of a Material Adverse Effect in the Tiffany Merger Agreement is clear. It was common before COVID-19 for transactions to contain a pandemic carveout. In the course of the negotiation, Tiffany sought and received carveouts for highly specific events, such as 'cyberattacks';, the 'Yellow Vest' movement and the 'Hong-Kong Protests'. Yet Tiffany did not obtain a carveout for public health crises or pandemics."
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CCL | Hot Stocks05:44 EDT Carnival Cunard announces new nine month program in 2021 - Cunard's new 2021 itineraries on Queen Elizabeth have gone on sale. The ship will chart three to 14 night voyages around Europe before making her way through Asia to Australia to end the season. The new program will start in Southampton on April 27 and end on December 19, 2021 in Melbourne, Australia. The 2021 itineraries will feature a series of overnight port calls to Amsterdam, Copenhagen, Lisbon, Rotterdam, Singapore and Auckland, with late evening departures from Amsterdam, Barcelona, Rotterdam, Aqaba, Colombo and Fremantle.
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ELLO | Hot Stocks05:41 EDT Ellomay Capital reports mechanical completion of Talasol Project - Ellomay Capital reported that the photovoltaic plant constructed by Talasol Solar S.L., with a peak capacity of 300MW in the municipality of Talavan, Caceres, Spain, reached mechanical completion. The company owns 51% of Talasol Solar S.L. Ran Fridrich, CEO and a board member of the company, commented: "This is a very important milestone in the development and construction of The Talasol project, which is one of the largest mega-projects built in Europe in the past year. Despite potential difficulties and delays due to the Covid-19 crisis, the Talasol project reached mechanical completion, meeting the schedule and the budget. The process of connection to the grid, which is expected to take between 5-7 weeks, is expected to commence shortly."
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PII | Hot Stocks05:40 EDT Polaris, Zero Motorcycles enter 10-year partnership to co-develop EVs - Polaris announced it has signed a 10-year partnership with Zero Motorcycles. This exclusive partnership in off-road vehicles and snowmobiles is a component of rEV'd up, Polaris' long-term strategy to position the company as the leader in powersports electrification. Through rEV'd up, Polaris aims to offer customers an electric vehicle, or EV, option within each of its core product segments by 2025, with the first vehicle from the Zero-Polaris partnership debuting by the end of 2021.
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NOK | Hot Stocks05:38 EDT Nokia signs 5G equipment provider deal with BT - Nokia announced that it has extended its long-term strategic relationship with BT into the 5G arena, following its selection as a 5G RAN vendor for the UK operator. As part of the deal, which will make Nokia BT's largest equipment provider, Nokia will provide equipment and services at BT radio sites across the UK, helping to evolve BT's radio access network to 5G. BT's Nokia-powered network, which currently includes Greater London, the Midlands and rural locations, will be extended to also cover multiple other towns and cities across the United Kingdom. This enhanced Nokia footprint will support BT's commitments to the UK government around the use of high risk vendors, or HRVs, in UK network infrastructure. Nokia will supply its AirScale Single RAN, or S-RAN, portfolio for both indoor and outdoor coverage, including 5G RAN, AirScale base stations and Nokia AirScale radio access products. These solutions will enable BT to build on its existing network leadership in the UK to deliver connectivity and capacity benefits to consumers at ultra-low latencies as well as reducing complexity and increasing cost efficiencies. The deal will also see Nokia optimize BT's 2G and 4G networks and work alongside BT on the development of the OpenRAN ecosystem. As part of BT's network transformation, the operator will also utilize Nokia Software's ng-SDM and NetAct network management platform, supporting the network evolution to 5G. These build upon the existing network architecture and provide an immediate cornerstone and single platform for new 5G-based services.
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AVYA... | Hot Stocks05:34 EDT Avaya, RingCentral announce expansion of Avaya Cloud Office across Europe - Avaya (AVYA) and RingCentral (RNG) announced the expansion of Avaya Cloud Office by RingCentral across Europe, with the solution now generally available in France, Ireland and the Netherlands. In addition, the companies also announced that they have signed their first seven-figure deal with a United Kingdom-based government customer. This geographic expansion of Avaya Cloud Office follows the launch of the solution in Canada, the United Kingdom and Australia in June and the United States in March. Since then, the solution has seen uptake continue to accelerate, with a growing number of new customers being signed across every country in which Avaya Cloud Office is available. Avaya has initiated a go-to-market strategy in Europe, having announced new master agent partnerships to meet the growing regional demand for Avaya Cloud Office. Avaya has signed a new master agent agreement with Itancia and ScanSource (SCSC) to rapidly enable adoption of the solution in France. The Netherlands will see Avaya Cloud Office offered by ScanSource. Finally, Avaya has expanded its master agent agreement with Westcon so that it now covers Ireland, France and the Netherlands.
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ACIW MA | Hot Stocks05:30 EDT ACI Worldwide, MasterCard to collaborate to provide payment solutions globally - ACI Worldwide (ACIW) and Mastercard (MA) announced that they will partner to provide a wide range of real-time payment solutions globally. They will initially collaborate to offer central infrastructure, payments localization and access solutions to central banks, scheme operators, financial institutions, payment service providers, and other organizations launching real-time payments initiatives. With a complementary real-time payments vision, the combination of Mastercard's central infrastructure and ACI's payments access and real-time message transformation technology delivers an end-to-end offering.
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SPGI | Hot Stocks05:28 EDT S&P Global Platts announces Petronet LNG selects WIM for LNG cargo tender - S&P Global Platts announced that Petronet LNG has adopted the Platts West India Marker, or WIM, for a tender to buy an LNG spot cargo in November. The LNG cargo will be delivered to Petronet's Dahej or Kochi terminals. This marks the first time an Indian LNG company has concluded a spot cargo tender priced off the Platts WIM.
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FCAU PUGOY | Hot Stocks05:25 EDT Fiat Chrysler, Peugeot announce Stellantis board composition - Fiat Chrysler (FCAU) and Peugeot (PUGOY) announce the composition of the board of Stellantis, the new company that will result from the combination of their respective businesses. Consistent with the terms of their combination agreement, announced on December 18, 2019, the board of Stellantis will be comprised of 11 members, the majority of the non-executive directors being independent. FCA and its reference shareholder Exor have nominated five members and Groupe PSA and two of its reference shareholders have nominated five members. Carlos Tavares, Stellantis' CEO, will also be a member of the board. The full composition of the Stellantis board will be as follows, subject to shareholder vote: John Elkann, Robert Peugeot, Henri de Castries, Andrea Agnelli, Fiona Clare Cicconi, Nicolas Dufourcq, Ann Frances Godbehere, Wan Ling Martello, Jacques de Saint-Exupery, Kevin Scott and Carlos Tavares. Completion of the proposed combination is expected to take place by the end of Q1 of 2021, subject to the previously agreed conditions to closing in the combination agreement.
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MGNI DISCA | Hot Stocks05:20 EDT Magnite announces expanded relationship with Discovery for advertising - Magnite (MGNI) announced its expanded relationship with Discovery (DISCA) in support of its real life entertainment streaming service, dplay platform, to maximise programmatic advertising capabilities. Magnite's platform provides Discovery with control for ad podding, inventory hierarchy, targeting and real-time reporting. Magnite will also develop custom solutions to support Discovery's product range and roadmap, as well as auction capabilities, like bidding, in a private environment.
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CYAD MRK | Hot Stocks05:14 EDT Celyad, Merck enter collaboration to evaluate CYAD-101 with Keytruda - Celyad (CYAD) announced that the company has entered into a clinical trial collaboration with Merck (MRK), through a subsidiary. Celyad Oncology will conduct the Phase 1b KEYNOTE-B79 clinical trial, which will evaluate Celyad Oncology's investigational non-gene edited allogeneic CAR T candidate, CYAD-101, following FOLFIRI preconditioning chemotherapy, with Merck's anti-PD-1 therapy, Keytruda in refractory metastatic colorectal cancer, or mCRC, patients with microsatellite stable / mismatch-repair proficient disease.
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SRNE | Hot Stocks05:10 EDT Sorrento Therapeutics releases preclinical STI-1499, STI-2020 data - Sorrento Therapeutics released preclinical data reporting on COVI-GUARD and COVI-AMG neutralizing antibodies, or nAbs, against SARS-CoV-2 as well as a D614G virus variant infection in a preprint publication. Both STI-1499 and STI-2020 demonstrated potent neutralizing activities against SARS-CoV-2 virus infection in preclinical models. STI-1499 nAb has been cleared by the FDA for a Phase 1 clinical trial in hospitalized COVID-19 patients. STI-2020 is an affinity-matured version of the COVI-GUARD nAb and has demonstrated a greater than 50-fold increase in potency in in vitro experiments. In preclinical cell-based assay, both STI-1499 and STI-2020 have shown 100% in vitro neutralization of SARS-CoV-2 at concentrations of six microgram/ml and 78 ng/ml, respectively. The neutralization activity at these concentrations protected against both SARS-CoV-2 and the highly contagious Spike D614G isolate. The company has generated preclinical animal data for STI-1499 and STI-2020 nAbs in a Syrian golden hamster model infected with SARS-CoV-2. A few highlights of the data from the most recent STI-2020 study: Hamsters infected with SARS-CoV-2 and then treated with a single dose of 500 microgram STI-2020 started gaining weight within 48 hours of STI-2020 administration, as compared to control animals that steadily lost weight for five days before recovery. At day 5, STI-2020-treated hamsters had gained 5% weight, versus a weight loss of about 10% for the control animals. At day 5, all STI-2020-treated hamsters had undetectable virus load in lungs as compared to the lungs of animals in the control group, where more than 1,000 infectious viral particles per gram of tissue were readily detected. Based on interspecies allometric scaling methods, the 500 microgram single dose of STI-2020 administered to the hamsters in the preclinical studies would be equivalent to a human dose of less than 100 mg of antibody. In contrast to other currently-used dosing regimens requiring grams of antibody per patient for treating COVID-19, this antibody could be highly potent at a very low dose. COVI-AMG could therefore potentially be administered as a rapid injection to treat COVID-19 patients.
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PCG | Hot Stocks05:06 EDT PG&E restores power to customers impacted by PSPS event - PG&E has restored power to essentially all customers who can receive service that were impacted by the Public Safety Power Shutoff, or PSPS, event that started early on September 27. The PSPS event was initiated due to a severe weather pattern that included strong, dry winds coupled with elevated temperatures in portions of the Northern and Central Sierra region. The scope of the PSPS included nearly 65,000 customers in 15 counties, including: Alpine, Amador, Butte, Calaveras, El Dorado, Lake, Napa, Nevada, Placer, Plumas, Shasta, Sierra, Tehama and Yuba counties. Two customers within Sonoma County were also included in this PSPS. A few customers in Kern County had initially been included, but due to improved weather conditions, were removed from the scope. Once the strong winds subsided Monday morning and the weather "all clear" was given, PG&E crews began patrols on the ground beginning early Monday morning to inspect more than 3,915 miles of transmission and distribution power lines for damage or hazards. This patrol and inspection effort included nearly 1,700 ground personnel and 50 helicopters. PG&E crews began restoring customers in areas where they found no damage or hazards to electrical equipment. In areas where equipment was damaged by the severe wind event, crews worked safely and as quickly as possible to make the repairs and restore those customers. Preliminary data shows 13 instances of weather-related damage and hazards in the PSPS-affected areas. Examples include downed lines and vegetation on power lines. If PG&E had not de-energized power lines, these types of damage could have caused potential wildfire ignitions. PG&E continues to monitor the Glass and Zogg Fires and is working closely with first responders and Cal Fire. Approximately 24,000 PG&E customers in Napa, Sonoma, Shasta and Tehama Counties impacted by wildfires are without power. In some instances, power was turned off in partnership with Cal Fire and for the safety of firefighters in active fire areas or due to damage caused from wildfire related impacts to equipment. PG&E has not filed an Electric Incident Report related to these fires, and has no information indicating that the Glass or Zogg fire ignitions could be attributable to its facilities.
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