Stockwinners Market Radar for September 14, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
ON | Hot Stocks20:37 EDT ON Semiconductor CEO sells 300K shares of common stock - In a regulatory filing, ON Semiconductor disclosed that its CEO Keith Jackson sold 300K shares of common stock on September 10th-11th in a total transaction size of $6.5M.
|
CP | Hot Stocks19:51 EDT Canadian Pacific opens new multi-commodity transload facility in Montreal - The company states: "Canadian Pacific will officially open its new multi-commodity transload facility in Montreal tomorrow. The new facility will offer transloading services and supplementary intermodal transportation and distribution services from CP's Cote Saint-Luc yard, with more space available for future expansions to provide customers with access to new markets. CP will operate the facility with TYT Group, a Quebec-based freight transportation services provider. The new rail-served facility features 118,000 square feet of customizable space designed to receive, unload, carry and deliver rail traffic for various commodities. Surrounded by more than 4,000 feet of existing and adjacent track, the location is ideal for indoor or outdoor transloading operations to keep goods moving efficiently on and off rail and throughout the broader supply chain."
|
RLGT | Hot Stocks19:18 EDT Radiant Logistics up over 7% at $5.57 per share after preliminary Q4 results
|
SKT | Hot Stocks18:03 EDT Tanger Factory says open stores account over 98% of total occupied - The company states: "The company's operations generated positive cash flow again in August. Tanger repaid its unsecured lines of credit in full during August using internally generated cash flow. The company had total liquidity at the end of August of approximately $606.6 million, including $6.6 million of cash on hand and $600.0 million of unused capacity under its lines of credit. For August, rent collections improved to 85% of billed rents, excluding variable rents and lease termination fees. July collections represented 81% of rents billed, up from the 77% previously reported on August 4, 2020. Second quarter collections have improved to 40% of rents billed from 33% as previously reported as of July 31, 2020. Consolidated portfolio occupancy at the end of August was 93.7%, reflecting year-to-date store closures totaling 542,000 square feet related to tenant bankruptcy filings and restructuring announcements. As of September 13, open stores represented over 98% of total occupied stores in the consolidated portfolio and nearly 98% of both leased square footage and annualized base rent. Traffic over the last six weeks has averaged 89% of prior year levels."
|
GRAF | Hot Stocks17:45 EDT Graf Industrial sets shareholder meeting to approve combination with Velodyne - Graf Industrial announced that it has scheduled the special meeting of its stockholders to approve its proposed business combination with Velodyne for September 29, 2020. Graf, whose securities are currently listed on the New York Stock Exchange, also announced that it intends to list the shares of common stock and warrants of the post-combination company, to be named Velodyne Lidar, Inc., on The Nasdaq Stock Market LLC under the ticker symbols "VLDR" and "VLDRW", respectively, following the closing of the Business Combination.
|
RTX | Hot Stocks17:32 EDT Raytheon Technologies subsidiary awarded $103.58M Army contract - Rockwell Collins was awarded a $103.58M firm-fixed-price contract to acquire avionics support services and incidental materials for the UH-60M Black Hawk multifunction display avionics suite for UH-60M mission design series and variant helicopters. Bids were solicited via the internet with one received. Work locations and funding will be determined with each order, with an estimated completion date of September 15, 2025. U.S. Army Contracting Command is the contracting activity.
|
SPG | Hot Stocks17:32 EDT Simon Property will not open properties on Thanksgiving Day - Simon announced it will not open properties on Thanksgiving Day. "In these challenging times, we made the decision that we will not open on Thanksgiving Day, instead allowing our associates to spend the holiday with their loved ones," said David Simon, Chairman, Chief Executive Officer and President of Simon.
|
VAC | Hot Stocks17:21 EDT Marriott Vacations to lay off 3,800 staff, sees pandemic impact 'longer, deeper' - In a regulatory 8K filing, the company states: "As you are aware, across the globe, many travel and leisure companies have been hit extremely hard by the COVID-19 pandemic, and we are no different. While occupancies have rebounded to some extent in many of our drive-to resort destinations, they remain low by historic standards, and several key markets, such as Orlando and Hawaii, continue to experience very low occupancies. For our exchange business, while we have seen exchange transactions rebound over the summer, business activity and revenue remain substantially lower than prior years. Over the past six months, the Executive Committee and I have made several difficult decisions and taken a number of actions to lessen the impact of the pandemic on our associates while ensuring the financial viability of the company. But the impact of the pandemic has been deeper and longer than initially expected. Given current business levels and our near-term recovery expectations, we have come to the conclusion that the company can no longer sustain its existing cost structure. As a result, we are now in the position where involuntary layoffs impacting approximately 3,300 of our associates are necessary."
|
LEN | Hot Stocks17:17 EDT Lennar chairman sees Q4 closings 15.5K-16.0K - Sees Q4 average sales price $390K vs. $396K in Q3. Chairman Miller states: "Balancing the early year pause with currently robust market conditions, we expect fourth quarter closings of 15,500 - 16,000 homes with gross margins in the 23.25% - 23.5% range. Given strong demand and limited new and existing home inventory, we expect home sales to remain strong for the foreseeable future. As we maintain a balance between sales and deliveries, we expect fourth quarter sales between 13,800 and 14,300 homes."
|
LEN | Hot Stocks17:15 EDT Lennar chairman says Q3 benefited from 'robust market conditions' - Executive Chairman Stuart Miller says: "Our third quarter results benefited from robust market conditions combined with the solid execution of our homebuilding and financial services businesses. Fundamentals in the housing market continued to remain strong supported by record low interest rates and a continued undersupply of new and existing inventory. The housing market continued its strong rebound from the significantly weaker sales environment earlier in the year as a result of COVID-19... During the quarter, we used the strength of the homebuilding market to accelerate starts to catch up on production lost earlier in the year. We carefully matched new orders and starts, with a continued focus on cash management which has led to greater returns. In the third quarter, new orders and starts were up 16% and 17%, respectively, over last year. As expected, our new home deliveries, limited by the production pause in the second quarter, increased only 2% over last year, but our gross margin climbed to 23.1%, a 270 basis point increase over the prior year, and our net margin reached an all-time, third quarter high of 15.1%. Additionally, we paid off approximately $400 million of debt during the quarter, had no borrowings under our $2.4 billion revolving credit facility and ended the quarter with $2.0 billion in cash and homebuilding debt to capital ratio of 29.5%, an all-time low."
|
LEN | Hot Stocks17:14 EDT Lennar reports Q3 deliveries up 2% at 13,842 homes - Reports Q3 : New orders of 15,564 homes - up 16%; New orders dollar value of $6.3B - up 20%; Backlog of 19,697 homes - up 4%; Backlog dollar value of $7.9B - up 4%.
|
HEXO | Hot Stocks17:13 EDT Hexo CFO Stephen Burwash to depart company, Trent MacDonald to succeed - Hexo announced that it has hired Trent MacDonald to join the company in the role of CFO, with a start date expected in the coming months. MacDonald will begin as CFO upon following Health Canada's personnel change and security clearance processes, as required for his position under the Cannabis Act and Cannabis Regulations. He will succeed Stephen Burwash, who will remain on as CFO through the transition period. MacDonald brings more than 15 years of financial executive experience to Hexo, working for both publicly listed and private enterprises. Most recently, he served as the CFO for Rx Drug Mart, a private pharmacy operator/consolidator, helping to guide it through significant growth in sales.
|
MGEN | Hot Stocks17:12 EDT Miragen up 12.8% after announcing new CEO, strategic review
|
MOS | Hot Stocks17:09 EDT Mosaic announces 741K tons of potash sold in August versus 755K tons last-year - The Mosaic Company announced its August 2020 sales revenue and sales volumes by business unit. The company sold 741K tons of potash in August 2020 compared to 755K tons in August 2019.
|
MGEN | Hot Stocks17:05 EDT Miragen Therapeutics conducting review of strategic alternatives - miRagen's board has determined it is in the best interests of the company and its stockholders to conduct a comprehensive review of available strategic alternatives with a focus on maximizing stockholder value. The board has engaged Ladenburg Thalmann & Co. Inc. as its financial advisor to assist in the strategic review process. Potential strategic alternatives may include, but are not limited to, an acquisition, merger, business combination, in-licensing, or other strategic transactions. There can be no assurance that this process will result in any such transaction. miRagen has not set a timetable for completion of this process and does not intend to comment further on this process unless or until the board has approved a definitive agreement.
|
MGEN | Hot Stocks17:05 EDT Miragen Therapeutics conducting strategic review of pipeline - The company is conducting a comprehensive review of its research and development pipeline, which includes MRG-229, cobomarsen, MRG-110 and remlarsen. The company plans to prioritize its resources toward advancing the development of its lead compound, MRG-229, for Idiopathic Pulmonary Fibrosis, IPF. MRG-229 is a conjugated miR-29 mimic that acts to replace miR-29, a microRNA that is found at abnormally low levels in a number of pathologic fibrotic conditions. Later this month, miRagen is scheduled to present new data from its recent non-human primate toxicology study of MRG-229 at the Oligonucleotide Therapeutics Society's annual meeting. This presentation will include data showing no adverse effects associated with MRG-229 when dosed up to 45mg/kg twice a week for two weeks. Following the announcement of these new data, the company is planning IND enabling activities for MRG-229, which are intended to advance the development of this potential therapy. The company also announced that it will conclude its Phase 2 SOLAR clinical trial of cobomarsen in patients with Cutaneous T-Cell Lymphoma, CTCL, and report topline data that has been collected to date in this clinical trial from 37 CTCL patients. The company believes that the controlled data from this set of patients can provide important evidence regarding the safety and efficacy of cobomarsen for the treatment of CTCL. miRagen plans to announce the topline data for its Phase 2 SOLAR clinical trial by the end of 2020. As this will be the first controlled clinical data available from CTCL patients, the company believes it may allow for a better assessment of the clinical potential of cobomarsen in this indication.
|
VVV | Hot Stocks17:03 EDT Valvoline to expand company-owned quick-lube network - Valvoline plans to acquire 14 quick-lube locations that will expand its company-owned service center network in Texas. The company has signed a definitive agreement with Kent Lubrication Center purchase its existing quick-lube centers which will be rebranded as Valvoline Instant Oil ChangeSM service centers. This acquisition is expected to close in the company's first quarter of fiscal 2021. Financial terms of the acquisition were not disclosed. "A core element of Valvoline's business strategy is to continue to grow and strengthen our industry-leading quick-lube network through organic store expansion and high-quality acquisitions in both core and new markets." said Tony Puckett, senior vice president and president, Valvoline Quick Lubes. "With Avis Lube's focus on customer service and employee professional training, their culture is an excellent fit for the Valvoline brand. These 14 service centers in the Midland/Odessa area will enable us to expand deeper into Texas beyond our current base of company and franchise service centers in the Houston, Dallas, San Antonio and Austin markets."
|
MGEN | Hot Stocks17:02 EDT Miragen Therapeutics appoints Lee Rauch as CEO - miRagen Therapeutics announced that its board has appointed Lee Rauch, the company's current COO, as president, CEO and a director, following the resignation of William Marshall. Marshall has also resigned from the company's board of directors and has agreed to act as Senior Technical Advisor to the company. Rauch, who joined miRagen in June 2020 as its COO, has more than 25 years of experience in the biotech and pharmaceutical industries. Rauch has held various executive positions at Global Blood Therapeutics, Onyx Pharmaceuticals, Nuon Therapeutics and COR Therapeutics.
|
TGH | Hot Stocks17:01 EDT Textainer increases share buyback by $50M - Textainer announced that its board authorized an increase to the company's share repurchase program of up to $50M of the company's outstanding common shares. The authorization is effective immediately and adds to the previous $50M program, which had approximately $1.0M remaining authorized and available for repurchase as of September 11, 2020.
|
KR | Hot Stocks17:00 EDT Kroger Dallas Division associates ratify new labor agreement - The Kroger Co. announced that associates working at 98 stores across Kroger's Dallas division ratified a new labor agreement with the United Food and Commercial Workers Union Local 1000. "Across the Kroger family of companies, we are proud that by the end of 2020 we will have increased our associate wage investments by approximately $800 million-$300 million more than we had originally planned as part of our Restock Kroger initiative," said Tim Massa, Kroger's senior vice president and chief people officer. "Kroger in Dallas is one of the numerous markets across the country that is rewarding and recognizing associates for their hard work with wage increases." The Kroger agreement includes: Increased wages for all associates; Ratification bonuses and retroactive pay for department heads, store leads, high-performing associates and other store positions; Improved Kroger health benefits including lower associate contributions and lower deductibles.
|
CLDT | Hot Stocks16:56 EDT Chatham Lodging CEO buys 45K share of common stock - In a regulatory filing, Chatham Lodging disclosed that its CEO Jeffrey Fisher bought 45K share of common stock on September 14th in a total transaction size of $348K.
|
NKLA | Hot Stocks16:54 EDT Nikola falls over 6% to $33.62 per share after Bloomberg report of SEC inquiry
|
LB NXGPY | Hot Stocks16:54 EDT L Brands forms partnership with Next plc for Victoria's Secret UK - L Brands (LB) announced a partnership with Next plc (NXGPY) for its company-owned Victoria's Secret business in the United Kingdom and Ireland. Under the agreement, which is subject to regulatory clearance, Victoria's Secret UK and Next plc have formed a joint venture, where the JV will acquire the majority of the assets of the Victoria's Secret UK business that is currently in Administration. The newly formed JV will operate all Victoria's Secret stores in the U.K. and Ireland, subject to agreeing to terms with landlords. The U.K. digital business, which is currently operated by Victoria's Secret in the United States, will be folded into the JV in Spring 2021. Under the terms of the agreement, Next plc will own 51% of the JV, while Victoria's Secret will own 49%.
|
GES | Hot Stocks16:39 EDT Guess CEO buys 83K shares of common stock - In a regulatory filing, Guess disclosed that its CEO Carlos Alberini bought 83K shares of common stock on September 10th in a transaction with total value of $1.0M.
|
PCTY | Hot Stocks16:33 EDT Paylocity director Diehl sells over $226K in company shares - Paylocity director Jeffrey Diehl sold 1,554 shares of company stock on September 10 at $145.48 per share for a total transaction value of $226,071.
|
VYGR | Hot Stocks16:30 EDT Voyager Therapeutics names Michelle Quinn Smith chief HR officer - Voyager Therapeutics announced the appointment of Michelle Quinn Smith as Chief Human Resources Officer. Smith brings over 30 years of experience in human resources to Voyager, including leadership roles at Flagship Pioneering, Takeda Pharmaceuticals, Genzyme, and Sanofi. "We are excited to welcome Michelle to Voyager in this important role. She brings a strong track record of purpose-driven, inclusive leadership, and will be a great addition to our team," said Andre Turenne, President and CEO of Voyager. "We believe Michelle's experience in driving organizational strategy in R&D organizations and growth companies will be instrumental in supporting our continued evolution as a gene therapy leader."
|
FSP | Hot Stocks16:29 EDT Franklin Street director McGillicuddy buys over $660K in shares - Franklin Street director Dennis McGillicuddy purchased 152,300 shares of company stock at $4.34 per share between September 10 and September 11 for a total of $660,327.
|
PUGOY FCAU | Hot Stocks16:27 EDT FCA, PSA to both consider potential distribution of EUR500M
|
PUGOY FCAU | Hot Stocks16:27 EDT FCA, PSA lower special dividend to EUR2.9B from EUR5.5B
|
FDX | Hot Stocks16:26 EDT FedEx units to increase shipping rates effective January 4th, 2021 by 4.9% - The company states: "FedEx Express, FedEx Ground and FedEx Freight, subsidiaries of FedEx Corp., will increase shipping rates beginning January 4, 2021. These rate changes enable FedEx to continue investing in service enhancement, fleet maintenance, technology innovations and other areas to serve customers more effectively and efficiently. FedEx Express shipping rates will increase by an average of 4.9% for U.S. domestic, U.S. export and U.S. import services. FedEx Ground and FedEx Home Delivery shipping rates will increase by an average of 4.9%. FedEx SmartPost shipping rates will also increase. FedEx Freight shipping rates will increase by an average of 4.9% for customers who use FXF PZONE and FXF EZONE, and by 5.9% for customers who use FXF 1000 and FXF 501 for shipments within the U.S. and between the contiguous U.S. and Canada. FedEx Freight shipping rates will also increase for shipments within Canada, within Mexico, and between the contiguous U.S. and Mexico."
|
PUGOY FCAU | Hot Stocks16:26 EDT FCA, PSA shareholders to receive equal 23% holdings in Faurecia
|
PUGOY FCAU | Hot Stocks16:26 EDT FCA, PSA amend certain terms of combination agreement - Fiat Chrysler (FCAU) and Peugeot (PUGOY) have agreed to amend certain terms of their binding 50/50 Combination Agreement to create Stellantis, the world's fourth largest global automotive OEM by volume. The parties have agreed the amendments in order to address the liquidity impact on the automotive industry of the COVID-19 pandemic while preserving the economic value and fundamental balance of the original Combination Agreement. The amendments have been unanimously approved by the Boards of both companies with the strong support of their reference shareholders. The existing commitments to support the transaction from EXOR, the Peugeot family Group, Bpifrance and Dongfeng Motor Group remain in effect. Specifically, the special dividend to be distributed by FCA to its shareholders before closing is set at EUR2.9B, previously EUR5.5B, while Groupe PSA's 46% stake in Faurecia will be distributed to all Stellantis shareholders promptly after closing following approval by the Stellantis Board and shareholders. As a result of these amendments, FCA's and Groupe PSA's respective shareholders will receive equal 23% shareholdings in Faurecia, while their 50/50 ownership of Stellantis - a group that will now have EUR2.6B more cash on its balance sheet - will remain unchanged. Additionally, it has also been agreed that the Boards of both Groupe PSA and FCA will consider a potential distribution of EUR500M to the shareholders of each company before closing or, alternatively, a distribution of EUR1B to be paid following the closing to all Stellantis shareholders. These decisions will be taken in light of the performance and outlook of both companies, market conditions and performance in the intervening period. Any such distributions will be made only if approved by the Boards of both companies. FCA and Groupe PSA confirm that in all other respects the economic terms of their Combination Agreement as signed on 17 December 2019 remain unchanged and that completion of the proposed combination is expected to take place by the end of the first quarter of 2021, subject to the previously agreed conditions to closing in the Combination Agreement. As a result of the significant progress made by the joint workstreams over the past months, the estimated annual run-rate synergies from the creation of Stellantis have been significantly increased to in excess of EUR5B from the EUR3.7B originally estimated. The total estimated one-time implementation cost of achieving these synergies has also increased from EUR2.8B to a figure of up to EUR4B.
|
CLPT | Hot Stocks16:20 EDT ClearPoint Neuro CFO Harold Hurwitz to retire, Danilo D'Alessandro to succeed - ClearPoint Neuro announced that global medical device financial executive Danilo D'Alessandro has been appointed the company's next CFO succeeding Harold Hurwitz who plans to retire in 2021. D'Alessandro will join the company on September 29, initially as VP of finance. D'Alessandro will assume the CFO position on January 1, 2021. D'Alessandro has a background in global corporate finance, financial planning and growth and M&A. D'Alessandro most recently served as the global head of finance of the image guided therapy devices division at Philips, a business unit representing cumulative inorganic investments of approximately $4B and more than 3,000 employees.
|
NEE | Hot Stocks16:18 EDT NextEra Energy approves 4-for-1 split - NextEra Energy board of directors has approved a four-for-one split of NextEra Energy common stock, which is intended to make stock ownership more accessible to a broader base of investors. Each shareholder of record on Oct. 19, 2020, will receive three additional shares of common stock for each then-held share, to be distributed on Oct. 26, 2020. Trading will begin on a stock split-adjusted basis on Oct. 27, 2020.
|
WK | Hot Stocks16:16 EDT Workiva selected by DOJ agencies to streamline performance management - Workiva announced that two agencies from U. S. Department of Justice, namely the Justice Management Division and the Bureau of Alcohol, Tobacco, Firearms, and Explosives, have selected the Workiva platform to streamline and automate a wide array of financial and performance management processes. Vertosoft, a government software distributor, was awarded the contract for Workiva to simplify and standardize complex workflows, data management, collaboration and reporting.
|
NEE | Hot Stocks16:16 EDT NextEra Energy raises FY21 EPS by 20c to $9.60-$10.15, consensus $9.88
|
AIZ | Hot Stocks16:15 EDT Assurant names Dimitry Dirienzo chief accounting officer - Assurant announced that Dimitry DiRienzo has been named senior vice president, chief accounting officer and controller. He will report to Richard Dziadzio, executive vice president, chief financial officer. "Dimitry's extensive and diverse financial background provides a depth of experience that will be highly valued and leveraged across our global organization," said Dziadzio. "I look forward to his partnership as he leads our global accounting team."
|
GNMK | Hot Stocks16:15 EDT GenMark's Diagnostics' ePlex respiratory pathogen panel 2 achieves CE mark - GenMark Diagnostic announced that it has achieved CE Mark under the European In-Vitro Diagnostic Devices Directive (98/79 for its ePlex Respiratory Pathogen Panel 2. The molecular test provides results in less than two hours for more than 20 viruses and bacteria that cause common and often serious respiratory infections, including COVID-19, influenza A and B, respiratory syncytial virus (RSV) and rhinovirus. This panel was previously made commercially available in the U.S. and is awaiting Emergency Use Authorization by the FDA. A syndromic diagnostic test, RP2 provides rapid results for infections with similar symptoms such as fever, cough and body aches, which will be critical in preparing for fall and winter as the flu season coincides with the ongoing risk of COVID-19. "Fast and comprehensive molecular testing has become even more essential since the arrival of COVID-19," said Scott Mendel, President and CEO of GenMark. "Cold and flu season is right around the corner and while we can't predict what it will be like, healthcare systems and providers must be prepared. Syndromic testing will be vital in helping health care professionals accurately diagnose seriously ill patients with similar symptoms, speeding up treatment and helping improve resource management."
|
CWH | Hot Stocks16:14 EDT Camping World believes it can grow adj. EBITDA in mid-single digits over 5 years - Camping World Holdings outlined the following initiatives and 2021 outlook highlights: The company believes it can grow adjusted EBITDA in the mid-single digits over the next 5 years, with a goal of generating more than $500 million in Adjusted EBITDA in 2021, up from a projected range of $460 to $490 million in 2020. Annually, the Company is targeting a minimum Adjusted EBITDA margin of 7.5% and SG&A expenses as a percentage of gross profit of approximately 68%. The company's goal is to have a net leverage ratio of less than 2.0x by December 31, 2020. Currently each of the company's 2.1 million Good Sam Members generate average annual revenue of approximately $1,850. The company's goal is to grow both its file size and average revenue per member by 10% in the next 36 months. The company has launched proprietary technology this year called the Good Sam RV Valuator. This technology leverages over 15 years of internal data and a proprietary algorithm to generate fair market values of all used RV inventory. The company believes this could benefit its used vehicle revenue growth by up to an additional 5% annually. The company plans to launch a new peer-to-peer RV rental marketplace in the spring of 2021. The company believes this platform will expand the RV community, provide Good Sam Members an opportunity to yield a return on their RV investment, generate opportunities to source used inventory, and introduce the breadth of products offered by the company to a larger consumer base. The company plans to launch a mobile service marketplace in the spring of 2021 that allows Good Sam Members to schedule service appointments and request immediate support from independent repair centers and mobile service providers. In exchange for a monthly fee, independent repair centers and mobile service providers will be provided a platform to join the network. This marketplace embodies the philosophy of supporting the RV enthusiast, which is shared by our Good Sam Park Network and Good Sam Roadside Assistance. The company is committed to investing heavily in product development that continues to create more efficient, more responsible, light weight, innovative and tech-savvy products both with RV's and the products that complement them.
|
NKLA | Hot Stocks16:12 EDT Nikola executive chair Milton buys 41,400 shares - In a regulatory filing, Nikola executive chairman Trevor Milton disclosed his purchase of 41,400 shares of Nikola's common stock in transactions with average price per share ranging from $30.10 to $33.60 on September 14.
|
MDLA | Hot Stocks16:07 EDT Medallia acquires Sense360 for about $44M in cash - Medallia announced it has acquired Sense360, the next generation consumer insights platform. Sense360 provides always-on, consumer and competitive intelligence from buyer and non-buyer segments and answers pressing questions such as what is driving traffic, what are the growth opportunities in a specific market and which competitors are gaining share and why. "We are thrilled to join forces with Medallia as the combination of our extensive consumer intelligence paired with the leading customer experience platform and signals breadth is a game changer," said Eli Portnoy Founder and CEO of Sense360. "Bringing our solutions together will create the comprehensive real-time insights that are acutely needed to make strategic decisions on how to grow the business at this moment." Under the terms of the agreement, Medallia acquired Sense360 for approximately $44M in cash, subject to certain adjustments as set forth in the merger agreement.
|
RICK | Hot Stocks16:06 EDT RCI Hospitality appoints Bradley Chhay CFO - RCI Hospitality Holdings announced Bradley Chhay will succeed Phillip Marshall as CFO effective today as part of a planned transition. Marshall, who has been CFO since 2007, will continue as part of RCI's Financial Team to assist in ensuring a smooth transition and will continue focusing on income tax matters. In his new position, Chhay will be responsible for managing all financial functions and strategy, as well as corporate development, mergers and acquisitions, and integration. After briefly serving as CFO for a smaller, privately-held, multi-unit restaurant chain, Chhay joined RCI in November 2015 as Controller.
|
NVS | Hot Stocks16:04 EDT California AG announces $11.8M settlement against Novartis - California Attorney General Xavier Becerra announced an $11.8M settlement against Novartis Pharmaceuticals related to allegations that the company engaged in a kickback scheme from January 2002 through November 2011 that impacted beneficiaries of Medicare and Medi-Cal. Novartis was accused of violating the federal Anti-Kickback Statute and False Claims Act, as well as the California False Claims Act, by offering payment in the form of cash, meals, and honoraria to healthcare practitioners to encourage them to prescribe certain Novartis drug products, including drugs such as Lotrel, Valturna, Starlix, Tekamlo, Diovan HCT, Tekturna HCT, and Exforge HCT, Diovan, and Exforge, to recipients of Medicare and Medicaid. Reference Link
|
MRNS | Hot Stocks16:02 EDT Marinus says ganaxolone met primary endpoint in Phase 3 trial - Marinus Pharmaceuticals announced positive top-line results from its registrational Phase 3 clinical trial evaluating the use of oral ganaxolone in children and young adults with CDKL5 deficiency disorder, a rare, genetic epilepsy with refractory seizures. In the trial, patients given ganaxolone showed a significant 32.2 percent median reduction in 28-day major motor seizure frequency, compared to a 4.0 percent reduction for those receiving the placebo, achieving the primary endpoint. The trial's primary efficacy endpoint was the percentage change in 28-day frequency of major motor seizures during the double-blind phase relative to the 6-week prospective baseline period. Ganaxolone was generally well tolerated with a safety profile consistent with previous clinical studies. The most frequent adverse event was somnolence. Based on these results, Marinus plans to submit an NDA for ganaxolone in the treatment of CDD to the U.S. Food and Drug Administration in mid-2021 and a Marketing Authorization Application for ganaxolone for the treatment of CDD to the European Medicines Agency by the end of Q3 2021.
|
BYD... | Hot Stocks15:42 EDT New Jersey reports August gaming revenue down 7.5% to $326.3M - New Jersey's Division of Gaming Enforcement reports that total gaming revenue for August was $326.3M, compared to $352.8M in August 2019, reflecting a 7.5% decrease. Internet gaming win was $87.8M in August compared to $41.1M in the prior period, reflecting an increase of 113.6%. Sports wagering gross revenue was $39.5M for the month. Casino win for August was $199.1M, decreasing 30.5% from the same month last year. "During August, the casinos operated with certain restrictions due to COVID-19," the DGE stated. 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). Reference Link
|
NFLX | Hot Stocks15:37 EDT Ted Cruz urges DOJ investigation of Netflix film 'Cuties' - U.S. Sen. Ted Cruz has sent a letter to Attorney General Bill Barr calling on the Department of Justice to investigate whether Netflix, its executives, or the makers of the film "Cuties" violated any federal laws against the production and distribution of child pornography, the Senator announced on September 11. Reference Link
|
FB | Hot Stocks14:55 EDT Facebook Gaming to let partnered streamers play copyrighted music - Facebook said that its Gaming unit is partnering with the music industry to open up a vast catalogue of popular music for Facebook Gaming Partners to play while livestreaming games. "Our work with music labels, publishers and societies, including Universal Music Group, Warner Music Group, Sony Music Entertainment, Kobalt Music Group, BMG Publishing, Merlin and many partners means you're able to include a vast amount of music across a variety of genres - current pop hits, dance floor beats, hip hop, 80s classics and much more," the company said. Reference Link
|
UUUU | Hot Stocks14:55 EDT Energy Fuels call U.S. agreement with Russia 'important step' - Energy Fuels announces that the U.S. Department of Commerce has obtained Russia's agreement to extend limits on uranium imports into the U.S. from Russia through 2040 under an extended Russian Suspension Agreement, or "RSA." Energy Fuels said: "This is an important step toward maintaining the long-term health of the U.S. uranium mining industry, especially since the expiration of the RSA at the end of 2020 could have resulted in unlimited Russian uranium imports into the U.S. Commerce won important concessions from Russia, including lower quotas starting in the mid-2020's, allowing only a portion of the quotas to be used for the sale of U3O8 and conversion into the U.S., and strict controls on Russian enrichment service contracts." Commerce is releasing a draft amendment of the RSA for public comment, with comments to be due by 5:00 pm EDT on September 28, and is seeking to finalize an amendment to the RSA no later than October 5, 2020, at which time it will go into effect and become binding on the U.S. and Russia, according to Energy Fuels.
|
SCIL | Hot Stocks13:59 EDT Scientific Learning acquired by affiliates of Carnegie Learning - Scientific Learning announced that it has been acquired by an affiliate of Carnegie Learning in an all-cash merger transaction valued at approximately $15M. Under the terms of the agreement, Carnegie Learning acquired all of the outstanding shares of Scientific Learning common stock for a cash payment of 53c per share. After applying a portion of the transaction value to items noted below, the estimated total per share consideration to be received by Scientific Learning's securityholders is approximately 25c, which comprises a closing merger consideration of approximately 16c per share and an estimated additional merger consideration of approximately 9c per share, on a fully diluted basis. The transaction was unanimously approved by Scientific Learning's Board of Directors, by a majority of Scientific Learning's stockholders via written consent, and by the Board of Directors of Carnegie Learning. Scientific Learning is now a privately-owned subsidiary of Carnegie Learning and will no longer be listed on the OTC Markets.
|
C | Hot Stocks13:49 EDT Citi sees Q3 reserve build meaningfully lower than prior quarters
|
C | Hot Stocks13:48 EDT Citi sees Q3 firmwide revenue up in the high single digit range y/y - Sees Q3 expenses roughly flat to up slightly. Says trading revenue has remained "strong" in Q3. Sees Q3 FICC revenue up in the low double digit range y/y.
|
C | Hot Stocks13:47 EDT Citi CFO sees total FY20 revenue flat to slightly down - CFO Mark Mason is speaking at the Barclays Global Financial Services Conference.
|
GDDY | Hot Stocks13:16 EDT GoDaddy agrees to acquire WooCommerce product developer SkyVerge - GoDaddy (GDDY) announced it has entered into a definitive agreement to acquire SkyVerge, which it calls "a leading WooCommerce product developer." All SkyVerge employees, including its co-founders and leadership team, will join GoDaddy. Financial details of the transaction were not disclosed. "SkyVerge advances GoDaddy's WordPress strategy and enhances our ability to deliver intuitive eCommerce experiences that help everyday entrepreneurs sell online. The SkyVerge team is incredibly talented and its WooCommerce expertise will play an instrumental role in accelerating the development of future WordPress eCommerce solutions," said Patrick Pulvermuller, President of the Partners Business at GoDaddy.
|
CLGX | Hot Stocks13:04 EDT CoreLogic confirms receipt of revised proposal from Cannae, Senator - CoreLogic confirmed that it has received a revised unsolicited proposal from Senator Investment Group LP and Cannae Holdings Inc. to acquire all outstanding common shares of CoreLogic for $66.00 per share in cash. Consistent with its fiduciary duties and in consultation with its financial and legal advisors, CoreLogic's Board of Directors will carefully review the revised proposal with the assistance of financial and legal advisors to determine the course of action it believes is in the best interests of the Company and its shareholders. CoreLogic previously announced on July 7 that its Board of Directors had unanimously rejected the unsolicited proposal from Senator/Cannae it received on June 26 to acquire all outstanding common shares of CoreLogic for $65.00 per share in cash. "After a careful and thorough review, conducted in consultation with its independent financial and legal advisors, CoreLogic's Board of Directors unanimously concluded that the unsolicited proposal significantly undervalues the company, raises serious regulatory concerns, and is not in the best interests of all shareholders. Since that time, CoreLogic has reported strong second quarter financial results, significantly increased forward guidance based on the strength of its business, raised its quarterly dividend by 50%, and committed to a $1 billion share repurchase. CoreLogic's Board of Directors will review the revised proposal from Senator/Cannae which reflects a proposed $1 per share increase and a request for due diligence."
|
PACB ILMN | Hot Stocks12:56 EDT FDA notes PacBio, Illumina technology use in COVID research project - The FDA posted a description of a Medical Countermeasures Initiative, or MCMi, regulatory science project during which the University of Liverpool and international partners will analyze SARS-CoV-2, SARS-CoV, and MERS-CoV clinical samples, collected through global partnerships, to better understand coronavirus evolution and virulence, characterize host-pathogen interactions and immunity, and identify biomarkers of disease progression and severity. "Through the sequence analysis of current and ongoing collection of samples from humans and animals, this project will help inform the real-time performance of molecular-based diagnostics," the FDA states in its post on the project. Among the primary planned outcomes of this project are to identify viral evolution in longitudinal samples taken from patients with MERS-CoV and SARS-CoV-2 using Illumina (ILMN), PacBio (PACB), and Oxford Nanopore-based technologies, the FDA post notes. Reference Link
|
CAH | Hot Stocks12:48 EDT Cardinal Health: Electives a bit better, pharma a bit worse than prior guidance - Comments taken from the Morgan Stanley Global Healthcare Conference.
|
GM | Hot Stocks12:37 EDT General Motors 'more committed than ever' to Cruise
|
GM NKLA | Hot Stocks12:33 EDT GM CEO: Questions swirling around Nikola should be referred to Nikola
|
GM | Hot Stocks12:33 EDT General Motors CEO: EVs core to strategy, will continue to build on strategy
|
GM NKLA | Hot Stocks12:30 EDT General Motors CEO: 'Appropriate diligence' done before Nikola deal - Comments taken from RBC Capital Markets Global Industrials Conference.
|
CZR... | Hot Stocks12:15 EDT Caesars announces deal with ESPN for William Hill sports book odds - As announced earlier today by Disney's (DIS) ESPN, Caesars Entertainment (CZR) has entered into a multi-year agreement with ESPN. The new deal includes link integrations from ESPN's digital platforms to sportsbooks from Caesars Entertainment's sports betting partner, William Hill (WIMHY). William Hill Sports Book's odds and markets connect directly to their sports betting apps in legalized states. The deal comes shortly after William Hill became the exclusive sports betting operator for Caesars Entertainment, following the merger with Eldorado Resorts, Caesars stated. "As our exclusive sports betting operator, William Hill has added immediate value to Caesars Entertainment's portfolio of properties nationally. Our new agreement with ESPN, as the largest provider in sports content, completes what is sure to be a momentous partnership in gaming and sports wagering," added Tom Reeg, CEO of Caesars Entertainment.
|
DIS DKNG | Hot Stocks12:07 EDT DraftKings announces co-exclusive content integration agreement with ESPN - DraftKings (DKNG) announced it has entered into a multi-year agreement with Disney's (DIS) ESPN to become a co-exclusive sportsbook link-out provider and exclusive daily fantasy sports provider of the "media giant." Links across ESPN digital platforms will connect fans to DraftKings' products and services. Under the agreement, DraftKings will now be able to integrate its products and offerings across ESPN's digital platforms. DraftKings will also power existing and future ESPN studio shows with dedicated segments for promotion, beginning with daily fantasy sports. "ESPN helped revolutionize the 24/7 sports news cycle and continues to be the go-to source for many fans today on the latest and largest sports stories," said Jason Robins, Co-Founder, Chairman and CEO, DraftKings. "We look forward to this collaboration to exclusively showcase DraftKings' daily fantasy content and offerings while also advancing further visibility and mainstream adoption of our regulated sports betting products."
|
M | Hot Stocks12:06 EDT Macy's Thanksgiving Day Parade to shift to TV only - Macy's and the City of New York announced details of the reimagined plan for the safe production of Macy's Thanksgiving Day Parade celebration. For the first time in its more than 90-year history, the annual Macy's Parade will be modified to safely bring the magic to more than 50 million viewers nationwide on Thanksgiving Day. This year the celebration will shift to a television only special presentation. As part of Macy's comprehensive health and wellness plan a number of changes will be implemented in order to execute this event safely. These changes include, but are not limited to the following: Reducing the overall number of participants by approximately 75%, and splitting the remaining participants over two days; All participants will be appropriately socially distanced during performances and be required to wear face coverings and additional personal protective equipment depending on their role; Shifting to a television-broadcast-only production with staging for Parade elements focused solely in/ around the Herald Square area of Midtown Manhattan; The traditional 2.5-mile Parade route will not be utilized this year; Previously selected regional High School and College Marching Bands performances will be deferred to the 2021 Macy's Parade, with locally based professional marching and musical ensembles taking musical duties in the lineup; Macy's traditional Giant Balloon Inflation public event on Wednesday will not take place.
|
WIMHY... | Hot Stocks12:05 EDT ESPN enters into co-exclusive agreements with Caesars, DraftKings - ESPN (DIS) announced that it has entered into two separate multi-year agreements with Caesars Entertainment (CZR) and DraftKings (DKNG). Both deals include co-exclusive link integrations across ESPN digital platforms connecting fans to sportsbooks from Caesars Entertainment's sports betting partner, William Hill (WIMHY), and DraftKings. As part of the new agreements, ESPN expands its relationships with both Caesars, as the exclusive odds provider and co-exclusive sportsbook link-out provider, and DraftKings, as the exclusive daily fantasy sports provider and co-exclusive sportsbook link-out provider. As part of the new Caesars agreement, Caesars Sportsbook by William Hill will also become a sponsor of ESPN's Fantasy products, deepening its relationship as ESPN's exclusive odds provider. The news follows the recent launch of ESPN's Las Vegas studio at The LINQ Hotel + Experience and its expanded content collaboration. Under the new DraftKings deal, DraftKings will also become ESPN's exclusive daily fantasy sports and co-exclusive sportsbook link-out provider. Additionally, DraftKings will power integrations across all ESPN content, beginning with daily fantasy sports segments on ESPN's premier studio shows.
|
VZ | Hot Stocks12:03 EDT Verizon forms partnership with The Paley Center for exclusive content rights - Verizon and The Paley Center announced a partnership that will grant the tech giant exclusive streaming rights to the Paley Center's robust lineup of 2020/2021 signature events. As part of the partnership, Verizon will also serve as the official sponsor of the Paley Center programs, including its premier public programs, signature television festivals, education programs, and the prestigious Paley International Council Summit. Verizon will also serve as the official sponsor of the Paley Center's "Tribute to Hispanic Achievements in Television." Verizon Media's brands, including Yahoo Finance, Yahoo News, Yahoo Sports, Yahoo Entertainment, and Yahoo Life, will have exclusive rights to livestream and broadcast Paley Center programs such as PaleyFest Fall TV Previews, PaleyFest Fall 2020, PaleyFest LA Spring 2021, Paley Front Row, A Tribute to Hispanic Achievements in Television, and the Paley International Council Summit.
|
PARR | Hot Stocks12:00 EDT Par Pacific falls -8.2% - Par Pacific is down -8.2%, or -66c to $7.36.
|
JDST | Hot Stocks12:00 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares falls -9.6% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is down -9.6%, or -$1.02 to $9.65.
|
LABD | Hot Stocks12:00 EDT Daily S&P Biotech Bear 3x Shares falls -19.7% - Daily S&P Biotech Bear 3x Shares is down -19.7%, or -$15.14 to $61.76.
|
NTP | Hot Stocks12:00 EDT Nam Tai Property rises 15.0% - Nam Tai Property is up 15.0%, or $1.37 to $10.51.
|
ZYME | Hot Stocks12:00 EDT Zymeworks rises 15.3% - Zymeworks is up 15.3%, or $5.86 to $44.13.
|
WTTR | Hot Stocks12:00 EDT Select Energy Services rises 18.1% - Select Energy Services is up 18.1%, or 73c to $4.76.
|
MSFT | Hot Stocks11:48 EDT Microsoft's cloud gaming service to launch with over 150 games - Microsoft unveiled the initial launch line-up of more than 150 games that Xbox Game Pass Ultimate members can play via the cloud in 22 countries starting September 15 at no additional cost. xCloud users will find a curated selection of games available in the Xbox Game Pass library, including Xbox Game Studios titles such as Tell Me Why, Grounded, Forza Horizon 4, and Battletoads, along with third party titles like Spiritfarer, Untitled Goose Game, and Destiny 2. Similar to Xbox Game Pass for Console and PC, users can expect the library to evolve over time based on members' feedback, with new games added all the time. "This is a pivotal step on our journey to put the player at the center of their experience and empower gamers to play the games they want, with the people they want, anywhere they want," said Kareem Choudhry, corporate vice president of Cloud Gaming at Microsoft. "What you'll see on day one is just the beginning. Over time we'll continue to innovate and add more games that you want." Reference Link
|
EGLE | Hot Stocks11:46 EDT Eagle Bulk Shipping announces 1-for-7 reverse stock split - Eagle Bulk Shipping announced that it has resolved to effect a reverse stock split of the Company's issued common stock and has determined the ratio to be 1-for-7. The Company's shareholders approved the reverse stock split and granted the Board the authority to determine the exact split ratio and when to proceed with the reverse stock split at the Company's Annual Meeting of Shareholders held on June 19, 2020. The reverse stock split will take effect on September 15, 2020 at 9:00 a.m. Eastern time, and the Company's common stock is expected to begin trading on a split-adjusted basis on the Nasdaq Global Select Market on the same day under the existing ticker symbol "EGLE". The new CUSIP number for the Company's common stock will be Y2187A 150. When the reverse stock split becomes effective, every seven shares of the Company's issued and outstanding common stock will be automatically combined into one issued and outstanding share of common stock without any change in the par value per share or the total number of authorized shares. This will reduce the number of outstanding shares of the Company's common stock from approximately 77.1M shares to approximately 11M shares.
|
CLUB | Hot Stocks11:32 EDT Town Sports files for Chapter 11 bankruptcy, says 'not going out of business' - Town Sports International announced to its members today that it and a number of its affiliates have filed voluntary Chapter 11 petitions to restructure under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware. The company said, "Town Sports intends to use the Chapter 11 process to engage in further discussions with their landlords and other creditors to successfully restructure their debts to best position the Company for long-term success in the current fitness industry environment. This includes our New York Sports Clubs, Boston Sports Clubs, Philadelphia Sports Clubs, Washington Sports Clubs, Lucille Roberts, Total Woman, and Around the Clock Fitness brands. With Chapter 11, companies generally seek a seamless transition in operations upon a filing, so our members will not recognize a break in service. Town Sports International is not going out of business. Restructuring is the best way to properly respond to the COVID-19 pandemic, with the long-term goal to emerge as a thriving powerhouse in the fitness industry. The goal is to emerge from Chapter 11 as an even stronger company, better positioned to serve members into the future. Town Sports will continue to operate its facilities as usual throughout this process, and members should not notice any changes to their fitness journeys. To ensure we operate in a safe and calculated manner, we will continue to reopen clubs as well as certain amenities in a 'phased' approach as we evaluate the best time and locations."
|
ALTR | Hot Stocks11:15 EDT Altair acquires Univa; terms not disclosed - Altair announced the acquisition of Univa, a company engaged in enterprise-grade workload management, scheduling, and optimization solutions for HPC and artificial intelligence on-premises and in the cloud. Altair will continue to invest in Univa's technology to support existing customers while integrating with Altair's HPC and data analytics solutions. These efforts will further enhance the capability and performance requirements for all Altair customers and solidify the company's leadership in workload management and cloud enablement for HPC. "Altair has invested significantly in HPC and cloud technologies for several years," said James Scapa, Altair's CEO and founder. "The addition of Univa's technology and its very experienced team further cements our leadership position in this fast-moving space."
|
BLL | Hot Stocks11:02 EDT Ball Aerospace selected by NASA for three studies to develop SLI technologies - Ball Aerospace was selected by NASA to move forward with three studies to develop and demonstrate innovative Sustainable Land Imaging technologies for potential use on future missions of the Landsat program, a series of Earth-observing satellite missions jointly managed by NASA and the U.S. Geological Survey that is entering its fifth decade of existence. The studies leverage previous SLI Technologies, including the Ball-built Operational Land Imager 2, which will fly on the Landsat 9 mission launching in 2021.
|
GOOGL GOOG | Hot Stocks11:00 EDT YouTube launches YouTube Shorts for 15-second videos - In a blog post, Chris Jaffe, VP of Product Management said, "We're excited to announce that we are building YouTube Shorts, a new short-form video experience right on YouTube for creators and artists who want to shoot short, catchy videos using nothing but their mobile phones. Over the next few days in India, we're launching an early beta of Shorts with a handful of new creation tools to test this out. This is an early version of the product, but we're releasing it now to bring you - our global community of users, creators and artists - on our journey with us as we build and improve Shorts. We'll continue to add more features and expand to more countries in the coming months as we learn from you and listen to your feedback. Here are more details on what to expect.Shorts is a new way to express yourself in 15 seconds or less." Reference Link
|
JNJ... | Hot Stocks10:26 EDT President Trump issues executive order on lowering drug prices - On September 13, President Donald Trump issued an "Executive Order on Lowering Drug Prices by Putting America First," which stated in part "When the Federal Government purchases a drug covered by Medicare - the cost of which is shared by American seniors who take the drug and American taxpayers - it should insist on, at a minimum, the lowest price at which the manufacturer sells that drug to any other developed nation." The order also stated: "It is the policy of the United States that the Medicare program should not pay more for costly Part B or Part D prescription drugs or biological products than the most-favored-nation price." Publicly traded large-cap drugmakers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Reference Link
|
ORCL | Hot Stocks10:21 EDT Oracle trading resumes
|
ORCL | Hot Stocks10:08 EDT Oracle says will serve as 'trusted technology provider' to ByteDance - Oracle confirmed in a press release Secretary Mnuchin's statement that it is part of the proposal submitted by ByteDance to the Treasury Department over the weekend in which Oracle "will serve as the trusted technology provider." The company added, "Oracle has a 40-year track record providing secure, highly performant technology solutions."
|
SIRI GM | Hot Stocks10:04 EDT SiriusXM extends, expands relationship with General Motors - SiriusXM (SIRI) announced an extension of its long-term agreement with General Motors (GM) that will continue the relationship between the two companies into 2027. As part of the new agreement, GM will increase vehicles equipped with SiriusXM to nearly all Chevrolet, Buick, GMC and Cadillac vehicles beginning with model year 2021. Chevrolet, Buick, GMC and Cadillac customers purchasing or leasing SiriusXM equipped vehicles will continue to receive a three-month trial subscription to SiriusXM All Access. Additionally, GM will continue to roll out its integration of SiriusXM with 360L to nearly 1 million Chevrolet, Buick, GMC and Cadillac vehicles
|
VIVO | Hot Stocks10:02 EDT Meridian Bioscience launches novel SARS-CoV-2 antibody pair - Meridian Bioscience announced the launch of a novel highly sensitive SARS-CoV-2 antibody pair to the trimeric spike protein to accelerate development of COVID-19 assays from patient saliva. Coronavirus-neutralizing antibodies primarily target the trimeric spike glycoprotein on the viral surface that mediates entry into the host cell. This antibody pair binds to recombinant SARS-CoV-2 trimeric spike protein. Intentionally designed and screened for the development of rapid saliva antigen tests, these antibodies recognize a linear epitope of the SARS-CoV-S1 trimeric protein. The antibody pair is the first-of-its-kind, having sensitivity down to picograms per milliliter as measured by ELISA. Further, the antibody pair is highly specific to the SARS-CoV-2 trimeric spike protein and does not cross react with other coronaviruses, such as SARS-CoV, HCoV-229F, HCoV-HKUI, HCoV-NL63 and HCoV-OC43.
|
SHLL | Hot Stocks10:00 EDT Tortoise Acquisition falls -6.7% - Tortoise Acquisition is down -6.7%, or -$3.21 to $44.57.
|
JDST | Hot Stocks10:00 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares falls -7.1% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is down -7.1%, or -76c to $9.91.
|
LABD | Hot Stocks10:00 EDT Daily S&P Biotech Bear 3x Shares falls -14.6% - Daily S&P Biotech Bear 3x Shares is down -14.6%, or -$11.25 to $65.65.
|
HMI | Hot Stocks10:00 EDT Huami rises 12.5% - Huami is up 12.5%, or $1.53 to $13.74.
|
NTP | Hot Stocks10:00 EDT Nam Tai Property rises 13.8% - Nam Tai Property is up 13.8%, or $1.26 to $10.40.
|
ZYME | Hot Stocks10:00 EDT Zymeworks rises 14.7% - Zymeworks is up 14.7%, or $5.64 to $43.91.
|
PRU | Hot Stocks09:47 EDT Prudential sees any COVID-19 vaccine being distributed slowly
|
PRU | Hot Stocks09:47 EDT Prudential: Share buybacks to remain on pause
|
SHLL | Hot Stocks09:47 EDT Tortoise Acquisition falls -5.6% - Tortoise Acquisition is down -5.6%, or -$2.68 to $45.10.
|
TWI | Hot Stocks09:47 EDT Titan International falls -6.4% - Titan International is down -6.4%, or -21c to $3.08.
|
LABD | Hot Stocks09:47 EDT Daily S&P Biotech Bear 3x Shares falls -12.1% - Daily S&P Biotech Bear 3x Shares is down -12.1%, or -$9.34 to $67.56.
|
ADCT | Hot Stocks09:47 EDT ADC Therapeutics rises 11.7% - ADC Therapeutics is up 11.7%, or $4.53 to $43.21.
|
GME | Hot Stocks09:47 EDT GameStop rises 12.6% - GameStop is up 12.6%, or 77c to $6.86.
|
ZYME | Hot Stocks09:47 EDT Zymeworks rises 16.6% - Zymeworks is up 16.6%, or $6.34 to $44.61.
|
PRU | Hot Stocks09:46 EDT Prudential sees staff working from home for rest of 2020 - Comments made at the Barclays Global Financial Services Conference.
|
GFSZY | Hot Stocks09:34 EDT G4S board 'unanimously' reject new proposal from BC Partners and GardaWorld - Following this morning's announcement by Garda World Security Corporation, the Board of G4S plc (GFSZY) confirms that on September 1, it received an unsolicited proposal from BC Partners and GardaWorld, regarding a possible cash offer of 190 pence per G4S share for the entire issued, and to be issued, share capital of G4S, which represents a premium of 31% to the price of 145 pence per share prevailing immediately prior to the announcement of the possible offer. This followed earlier proposals at 145 pence per share on June 15, 2020) and 153 pence per share on June 26, 2020, each of which was unanimously rejected by the Board. "Following careful consideration, together with its financial advisors, the Board of G4S unanimously rejected the new proposal on 12 September 2020, on the basis that it significantly undervalues the company and its prospects. The Board believes that the timing of the proposal is highly opportunistic, coming as it does at a time of severe turbulence in global financial markets. Furthermore the company's financial performance following the outbreak of COVID-19 has been particularly resilient, as outlined in the company's interim results for the six months ended 30 June 2020, issued on 23 July 2020. A further announcement will be made by the company in due course," G4S announced.
|
ORCL | Hot Stocks09:33 EDT Oracle trading halted, news pending
|
WFC | Hot Stocks09:32 EDT Wells Fargo: A lot of stimulus still sitting in customer accounts
|
WFC | Hot Stocks09:31 EDT Wells Fargo CFO: Q2 was 'high water mark' for trading
|
INPX | Hot Stocks09:31 EDT Inpixon announces approx. $2.6M in new orders for Indoor Intelligence platform - Inpixon announced it has received new and additional follow-on orders and subscription renewals with a value of approximately $2.6M during the third quarter of 2020 to date for the application of its Indoor Intelligence platform across multiple uses cases.
|
DMAC | Hot Stocks09:30 EDT DiaMedica Therapeutics doses first patient in DKD cohort of REDUX Phase II study - DiaMedica Therapeutics said in a release, "DiaMedica Therapeutics announced dosing of the first participants in the diabetic kidney disease, or DKD, cohort of the REDUX Phase II Chronic Kidney Disease, or CKD, study. In total, 16 additional participants have been enrolled in the REDUX study in the past six weeks, 11 of which were enrolled in the DKD cohort III, bringing the total enrolled participants to 34, including 11 African American subjects into cohort I and 12 subjects with IgA Nephropathy, or IgAN, into cohort II of the REDUX study. The Phase II REDUX clinical trial is a multi-center, open-label investigation targeting 90 participants with Stage II or III CKD, who will be enrolled in three equal cohorts. The study is being conducted in the United States at up to 13 sites. Cohort I is studying African Americans with hypertension but who are not diabetic. African Americans are at greater risk for CKD than Caucasians and those who have the APOL1 gene mutation are at an even higher risk. The study is designed to capture APOL1 gene mutation as an exploratory biomarker in this cohort. Cohort II is studying participants with IgA Nephropathy previously confirmed by biopsy. Cohort III is studying participants with Type II diabetes mellitus, hypertension and albuminuria."
|
TRXC | Hot Stocks09:26 EDT TransEnterix establishes first Asia-Pacific region Senhance training center - TransEnterix announced that it established the first training center for the Senhance Surgical System in the Asia-Pacific region in Japan at the Saitama Medical University International Medical Center in the Greater Tokyo Area.
|
WFC | Hot Stocks09:26 EDT Wells Fargo sees deposit, card fees higher in Q3 vs. Q2
|
GEL | Hot Stocks09:25 EDT Genesis Energy provides update on offshore operations, Q3 adjusted EBITDA - Genesis Energy provided an update on its offshore operations, following Hurricane Laura, as well as disclosed the receipt of some $41M in cash that will also be accounted for as an increase in reported adjusted EBITDA for Q3. The company said, "Turning first to the offshore, there is no apparent damage to our 100% owned and operated Cameron Highway Oil Pipeline System ("CHOPS") nor any of its appurtenant facilities. As currently configured, the CHOPS pipeline goes up and over a junction platform located in Garden Banks block 72, where it can receive pigs and launch pigs for proper maintenance of two of its 30 inch diameter pipeline segments. That platform, located in 520 feet of water, recorded waves in the 70-80 foot range and sustained winds in excess of 130 mph as the eye of Laura passed some 17 miles to the southwest of its location. The platform experienced damage to its topside facilities which is usual and customary, and not significant nor unexpected, after experiencing those type of weather conditions. Below the waterline, through diving and remotely operated vehicle inspections, several areas of structural stress have been identified that will require further investigation and analysis. As a result, no oil is currently flowing through the CHOPS pipeline. We are aggressively working to collect data and conduct a rigorous structural analysis for review by the Bureau of Safety and Environmental Enforcement to hopefully be able to re-occupy the platform, conduct the cleanup tasks required and return the CHOPS pipeline to normal operations. Based upon continuing data collection, observations and analysis, it would appear that CHOPS is more than likely not going to be in a position to resume operations before October 1 at the earliest. However, we have been successful, to date, in working with shippers to divert all available and affected CHOPS barrels into our 64% owned and operated Poseidon Oil Pipeline for deliveries by it directly to shore or for Poseidon to deliver barrels into the Auger Pipeline for further transportation to shore via this alternative path. Because of the rate structures amongst the various pipelines, we expect minimal revenue impact to Genesis during this period of interrupted operations of CHOPS, other than when the volumes were shut in for the storm, and assuming the continuing conditions that there is enough available capacity on Poseidon and/or Auger to receive and transport all of the affected CHOPS volumes. We would expect to incur total expenses associated with inspections, analyses and topside facility repairs in the range of $3-5 million, most of which will be reflected in the third quarter. Any potential costs associated with structural reinforcement or modification, either to the platform or pipeline facilities, will be treated as capital in future periods. We are working diligently and as hard as possible to determine what it will take to return CHOPS to normal service as soon as we can, while never losing sight of our commitment to safe and responsible operations. Shifting gears a bit, I would like to also take this opportunity to disclose that we have received approximately $41 million in cash that will be recognized as Adjusted EBITDA in the third quarter for covenant compliance purposes, all as more fully described in our senior secured credit agreement. The cash received is associated with the exercise of a letter of credit we had issued to us as beneficiary from a customer that defaulted under a twenty year term agreement entered into in 2008. The dollars collected from such contractual right will be credited to dollars owed us under the last years of the contract. Under the mechanics of said agreement, we will continue to be paid the dollars owed to us. Having already received this cash and being able to recognize it as increased Adjusted EBITDA this quarter is a positive development for us under the circumstances. Accordingly, we see no scenarios where we have the risk of not comfortably living within all of our financial covenants as we deal with the aftermath of this hurricane season and the Covid-19 pandemic which has directly and indirectly challenged our businesses, like virtually all others, but which are clearly recovering and looking forward to better things in 2021."
|
CSSE | Hot Stocks09:22 EDT Chicken Soup for the Soul Entertainment announces license deals for Crackle Plus - Chicken Soup for the Soul Entertainment announced new programming license deals for Crackle Plus. The new license deals cover over 1,000 hours of content from companies including Gravitas Ventures, Distribution Solutions, Insight TV, BGP Releasing, Asian Media Rights, MPI, and Binge Networks. The 1,000 hours of content includes movies, TV series, and documentaries with must-see programs like The Bill Murray Stories: Life Lessons Learned from a Mythical Man from Gravitas Ventures, a documentary series highlighting Americans' spontaneous and unexpected encounters with actor Bill Murray that has a 95% on the Rotten Tomatoes Tomatometer; and National Lampoon's Snatched from Distribution Solutions, the comedy film starring Andrew McCarthy and Ernest Borgnine. The above titles, alongside existing library titles, bring total Crackle Plus content to approximately 79,000 hours. This includes original and exclusive programming such as The Sonata, Blue Iguana, Corporate Animals, Crown Vic, The Clearing, On Point, Going From Broke, '85: The Greatest Team in Football History, Road to Race Day and Cleanin' Up the Town. Crackle Plus obtained the right to exhibit new content from various license deals through sister company Screen Media.
|
LODE | Hot Stocks09:22 EDT Comstock Mining completes Lucerne sale, recognizes $18M gain - Comstock Mining announced that it has completed the sale of its Lucerne mine to Tonogold Resources for total value and consideration of approximately $25.9M. The consideration includes $7.1M in cash, $6.1M in convertible preferred stock, or CPS and a $4.475M, 12% notes receivable, due and payable on September 20, 2021, plus the assumption of $6.7M in future lease and reclamation obligations, that together represent a permanent reduction of annual operating expenses of approximately $1M. The CPS had an initial recorded fair value of $7.6M. Comstock retained a 1.5% net smelter return, or NSR, royalty on Lucerne and will recognize a tax-free gain on the sale of approximately $18M, with substantially all of the gain expected in Q3. The company also entered into a long-lived mineral lease with Tonogold for additional mineral properties in Storey County, Nevada, granting Tonogold the mineral rights to these properties. Tonogold also announced that it recently completed a $4.25M equity capital raise, with now over $6M in cash on hand and an additional $3.5M in drilling equity credit, fully funding an estimated $7M drill program. Tonogold's initial drill program will focus on the nearly two-mile mineralized strike where most of the historical production and where more favorable mining conditions were enabled by the dewatering of the Sutro Tunnel. Comstock retains a 3% net smelter return royalty on these additional leased properties, reduced to 1.5%, one year after the commencement of mining operations.
|
CMTL | Hot Stocks09:21 EDT Comtech announces international service expansion with Indian Motorcycle - Comtech said in a release, "Comtech Telecommunications announced its Location Technologies group, a division of Comtech's Commercial Solutions segment, has finalized agreements with Indian Motorcycle. These agreements will enable expanded coverage for the Ride Command feature in Europe, the Middle East and Africa."
|
RNVA | Hot Stocks09:21 EDT Rennova Health to deploy rapid COVID-19 test at two hospitals - Rennova Health announced that it has purchased and taken delivery of equipment to provide rapid testing for Coronavirus Disease 2019 at three sites, two of its hospitals in East Tennessee and its rural clinic in Kentucky. Rennova entered an agreement with Abbott laboratories to install and provide the ID NOW testing to our facilities. ID NOW provides results in 15 minutes utilizing state of the art molecular techniques. This test is approved under U.S. Food and Drug Administration Emergency Use Authorization from direct nasal or noso-pharyngeal swabs. Testing is expected to begin in September at all 3 facilities. Patients may come to the facilities at their own wish or with a doctor's order for the testing and leave with a result.
|
WFC | Hot Stocks09:20 EDT Wells Fargo CFO: Demand for new credit 'not particularly robust'
|
WFC | Hot Stocks09:20 EDT Wells Fargo CFO: Cost cuts 'will be a little bit of everything'
|
KNDI | Hot Stocks09:19 EDT Kandi Technologies establishes China Battery Exchange Technology - Kandi Technologies Group announced the establishment of a wholly-owned subsidiary for its battery swapping services: China Battery Exchange Technology Co., Ltd. By establishing the China Battery Exchange Technology Company, Kandi can better monetize its dozens of patents in the field of battery swap systems. The new Company can also attract strategic investors to participate across the whole sector value chain, including battery swapping services and used battery recycling.
|
SPTN | Hot Stocks09:18 EDT SpartanNash appoints Tony Sarsam as CEO - SpartanNash announced that it has hired Tony Sarsam as President and CEO. The company said in a release, "Sarsam will assume that role and join the Board of Directors, effective September 21, 2020. Interim President and CEO Dennis Eidson will continue in his role as Chairman of the Board and will serve as Executive Chairman for a period of thirty days to ensure a smooth transition with Mr. Sarsam. Sarsam most recently served as CEO of Borden Dairy Company."
|
NOVN | Hot Stocks09:18 EDT Novan seeking potential strategic partner for companion animal program - Companion Animal Program: Initiated exploratory work to evaluate NITRICIL as a potential product candidate for antimicrobial indications in companion animal health. Program Highlights: Contracted drug delivery technology specialist to undertake initial formulation development to assess viability; Engaged animal health experts to assess technical feasibility and market potential; Target seeking a potential strategic partner or collaborator following initial proof-of-concept work.
|
NOVN | Hot Stocks09:17 EDT Novan targets year end to report findings from in vitro assessments of NITRICIL - Coronaviridae: Currently conducting in vitro assessments to evaluate the ability of NITRICIL to inhibit the replication mechanisms of SARS-COV-2. Program Highlights: Nitric oxide may inhibit viral replication by cytotoxic reactions through intermediates such as peroxynitrite; In vitro assessments targeting the reduction of viral shedding and transmission; Targeting year end to report findings from in vitro assessments.
|
CMTL | Hot Stocks09:16 EDT Comtech awarded $20M contract with tier-one carrier - Comtech said in a release, "Comtech Telecommunications announced that during its fourth quarter of fiscal 2020, its Location Technologies group, a division of Comtech's Commercial Solutions segment, has finalized a 5-year contract worth over $20.0 million for location-based services, or LBS, with a tier-one carrier as part of their 5G implementation."
|
NOVN | Hot Stocks09:16 EDT Novan expects topline results from B-SIMPLE4 Phase 3 study in 2Q21 - SB206: Topical antiviral gel for the treatment of viral skin infections, with a current focus on the treatment of molluscum contagiosum, a contagious skin infection caused by the molluscipoxvirus, a double-stranded DNA virus. Program Highlights: B-SIMPLE4 pivotal Phase 3 study for treatment of molluscum underway; Target completion of enrollment in Q1 2021; Topline results targeted for Q2 2021, subject to the timing and trial execution plan which have been and may be further impacted by the COVID-19 pandemic For more information about the B-SIMPLE4 trial, please visit clinicaltrials.gov and reference identifier: NCT04535531.
|
NTRA | Hot Stocks09:15 EDT Natera announces program for cancer patients in organ transplantation - Natera announced a program to improve care for organ transplant patients with a history of cancer, using the Signatera test for molecular residual disease, or MRD, assessment pre- and post-transplant, in combination with the Prospera test for transplant rejection assessment. The goal of the program is to understand how the Signatera and Prospera tests can be used to improve decision making at the complex intersection of organ transplantation and oncology, and respond to the unmet needs within these communities.
|
WFC | Hot Stocks09:15 EDT Wells Fargo sees 2020 NII of $40.5B vs. prior $41B-$42B range - Comments made by CFO John Shrewsberry at the Global Financial Services Conference.
|
NOVN | Hot Stocks09:14 EDT Novan directing pre-IND development activities toward work on cornaviridae - Novan provided a priority pipeline update. In addition to focusing its primary efforts toward SB206, its lead product candidate for molluscum, the Company is also directing pre-IND development activities toward the ongoing in vitro work related to coronaviridae, as well as exploring the potential of its NITRICIL platform technology for use in an antimicrobial indication for companion animal health. "Over the course of the past few months, we have dedicated time and efforts evaluating our internal pipeline of late-stage assets, our broader dermatology platform and underlying NITRICIL technology. These components represent what we believe to be a solid foundation to build momentum and support Novan's next phase of growth," commented Paula Brown Stafford, Chairman, President and CEO of Novan. "We are focused on successfully executing our pivotal Phase 3 study of SB206 for the treatment of molluscum, which is now underway and dosing patients, and are pleased with the progress our team has continued to make in this important program. Additionally, we have continued to make progress with our in vitro work to evaluate the ability of NITRICIL to target the replication mechanisms of SARS-COV-2 and target reporting of key findings from these assessments before year end. I am also pleased to announce that we have launched exploratory efforts to evaluate the use of NITRICIL for antimicrobial indications in companion animal health, an area we believe diversifies our pipeline and provides opportunities in an adjacent, yet important market."
|
MOTS | Hot Stocks09:12 EDT Motus GI Holdings announces patent for method to mount Pure-Vu System - Motus GI Holdings announced that the China National Intellectual Property Administration issued patent 201680002365, titled "Distal Front End for Coordination Positioning of an Endoscope with a Suction Device." The patent covers the method of mounting Motus GI's proprietary sensing technology and enhanced suction systems with the distal end of a colonoscope. This patent further protects the Company's flagship product - the Pure-Vu System - in this key potential market.
|
MGM | Hot Stocks09:11 EDT MGM Resorts to complete reopening of properties worldwide - MGM Resorts announced that Park MGM and NoMad Las Vegas will open their doors on September 30, completing the reopening of all of its properties around the world following closures earlier this year amid the Covid-19 crisis. Upon reopening, Park MGM/NoMad will be The Strip's first fully smoke-free casino resort.
|
AMIN | Hot Stocks09:11 EDT ZipDoctor executes marketing agreement with Captify Condulting - American International announced that it has retained the services of Captify Consulting to spearhead, support and champion the ZipDoctor's digital marketing and social media advertising efforts as it relates to its recently launched subscription based online telemedicine platform, located at www.ZipDoctor.co. Captify specializes in helping B2C companies, eCommerce Brands, and entrepreneurs scale and increase their revenue with highly-targeted, consistently-converting digital advertisement campaigns.
|
TRNF | Hot Stocks09:10 EDT Taronis Fuels announces execution of $20M in unit sales - Taronis Fuels provided a corporate update on recent international business developments related to an existing contract in the Republic of Turkey. Most importantly, the existing $18.75 million, five-unit purchase order was formally approved and released by the Turkish authorities, and the order has been modified to $20 million to account for additional design specifications unique to the Turkish market. All five units are currently in production, with the first units projected for shipment in January of 2021. Beginning on August 23rd, a technical and engineering team from Taronis was deployed for over two weeks in Ankara. The team was able to successfully commission a mobile 50KW Venturi plasma arc gasification unit at its new location in Gazi, on the southwest outskirts of Ankara. The unit was officially commissioned by technical and legal representatives from the Turkish Ministry of Finance and Trade on August 30, 2020. On September 3rd, the Company jointly hosted a commissioning and ribbon-cutting ceremony at the facility in Gazi. The event was widely attended by government officials, representatives from the majority of the industrial gas companies in Turkey, as well as a select group of prospective buyers of the gasification units both within Turkey and from neighboring markets in Central Asia. The Company subsequently conducted more than a dozen private demonstrations for prospective buyers of the gasification unit the week of September 7th. In particular, representatives from the majority of the leading industrial gas providers in Turkey participated in these private, technical presentations. Virtually all of these prospective buyers have expressed interest in securing access to scalable quantities of MagneGas, the Company's patented, renewable metal cutting fuel. In several instances, these industrial gas competitors have also expressed interest in purchasing one or more gasification units. In addition, the Company has identified multiple promising channels to sell MagneGas or gasification units into other end-use applications. As examples, the Company presented to a cement producer, an operator of hydroelectric power plants, and a steel foundry. In each instance, the prospective consumers require significant quantities of acetylene for their infrastructure. In several additional instances, the client expressed interest in the comingling, or co-combustion of MagneGas with traditional fossil fuel products to increase the efficiency of the combustion process. Taronis has previously researched this application and has validated that this co-combustion process can increase heat output by up to 800%, while reducing harmful emissions by up to 50%. This co-combustion opportunity may expand to include coal-fired electric power plants across much of Turkey. With 47 power plants producing over 19GW of power each year, Turkey is the 12th largest user of coal-powered electric utilities today. The use of MagneGas through co-combustion could quickly become the primary justification for the government to procure the remaining 25 gasification units under the $165 million, 30-unit contract currently in place through a Turkish joint venture in which Taronis Fuels is a 49% minority owner. As part of the initial $20M, five-unit funding approval, the Turkish government also granted the Turkish joint venture a five-year importation approval for both virgin and waste ethanol. Ethanol is in scarce supply in both forms in Turkey and is priced at a significant premium to prevailing market prices in Europe and the United States. Through the Turkish joint venture, the Company is actively looking to scale its existing relationship with Catalent, a global leader in the pharmaceutical manufacturing industry.
|
MYT | Hot Stocks09:09 EDT Urban Tea regains compliance with Nasdaq - Urban Tea announced that it has regained compliance with Nasdaq's minimum bid price requirement. The company received a written notification from Nasdaq, indicating that the company has regained compliance with the minimum bid price requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550 based on the company's closing bid price being $1.00 per share or greater for 10 consecutive business days from August 27 to September 10.
|
LOGM | Hot Stocks09:08 EDT LogMeln reports 25M LastPass users - LogMeIn announced that LastPass has reached a great milestone: 25 million LastPass users around the globe.
|
SEEL | Hot Stocks09:08 EDT Seelos Therapeutics issued patent from Japanese Patent Office covering SLS-002 - Seelos Therapeutics announced that it has received an issued patent from the Japanese Patent Office covering SLS-002. The issued claims cover a formulation and method of using SLS-002 to treat patients experiencing anxiety due to phobic disorders such as: Specific Phobia, Agoraphobia, and Social Phobia. Additionally, Seelos has received a Notice of Allowance from the Japanese Patent Office covering SLS-002. The allowed claims cover a formulation and method of using SLS-002 to prevent anxiety in patients prior to medical or dental procedures.
|
MSFT EEFT | Hot Stocks09:08 EDT Euronet's epay to manage transactions between Microsoft, retailers - Euronet Worldwide (EEFT) its epay division has been selected to manage monthly recurring billing between Microsoft (MSFT) and select telecommunications retailers for sales of Games Pass Ultimate and Xbox All Access subscriptions worldwide. The agreement covers two Xbox offerings for consumers: Xbox Game Pass Ultimate includes Xbox Game Pass for Console, Xbox Game Pass for PC, Xbox Live Gold, and Microsoft's recently announced Cloud Gaming that provides consumers access to more than 100 AAA console games streamable to their mobile Android devices in 22 markets for one low monthly price on a recurring monthly subscription basis. In a separate offering, Xbox All Access provides qualifying consumers with their choice of an Xbox One console and accessories plus a recurring monthly subscription to Xbox Game Pass Ultimate. The All Access subscription is billed to the consumer monthly with the cost of the console bundled with the gaming content. The consumer has no up front costs for the console at the point of purchase. This new agreement enables epay to help Microsoft reach an exploding new cloud-based mobile gaming market. With rising smartphone usage and introduction of 5G networks, studies suggest mobile games will generate revenues of $77.2 billion in 2020 worldwide and that the overall global gaming market including mobile, PC, and consoles will exceed $200 billion at the end of 2023. Xbox is a leading game platform in worldwide market share2, and the subscription option in the Xbox All Access offering is popular among consumers who are anticipating the expected release of new Xbox consoles at the end of 2020. Furthermore, Microsoft announced there were more than 10 million Xbox Game Pass members in 41 countries worldwide - all prior to delivering its traditional console gaming to 22 global mobile markets with Cloud Gaming.
|
VAR | Hot Stocks09:05 EDT Varian appoints Chris Toth as COO - Varian announced Chris Toth, Varian oncology systems president, has been appointed to the newly created role of president and COO. As President and COO, Toth will oversee Varian's business operations, including execution of the company's FY21 goals and strategic initiatives. Toth will continue to report to CEO Dow Wilson.
|
BYND | Hot Stocks09:05 EDT Beyond Meat launches Beyond Meatballs at grocery stores nationwide - Beyond Meat announced that Beyond Meatballs will be rolling into grocery stores nationwide starting this week. With more consumers looking for nutritious options that are delicious and easy to prepare, Beyond Meatballs are conveniently pre-seasoned with a signature blend of Italian spices, pre-rolled and ready to cook. The nutritious plant-based meatballs are made from simple, plant-based ingredients with no GMOs, soy, gluten or synthetic ingredients and have 30% less saturated fat and sodium. Beyond Meatballs will be launching at grocery stores nationwide including Whole Foods Market, Stop & Shop, Sprouts, Harris Teeter, Kroger, Albertsons, and others by early October. Sold in the fresh meat section with a suggested retail price of $6.99 for 12 meatballs, Beyond Meatballs have a juicy, meaty taste and texture, with a versatile flavor profile perfect for pastas, sandwiches, pizzas, soups and more.
|
PLYA | Hot Stocks09:03 EDT Playa Hotels & Resorts announces final phase of post pandemic openings - Playa Hotels & Resorts announced that their entire collection of all-inclusive resorts will be open by December 2020. Since early Summer, Playa has been bringing resort operations back online after temporarily suspending operations earlier in the year due to the COVID-19 pandemic. Recent guests have been welcomed by Playa's unmatched customer experience of all-inclusive luxury, the trust and assurance of legendary partners such as Hyatt and Hilton and leading safety measures as part of Playa SAFE STAY.
|
PACB | Hot Stocks09:02 EDT Pacific Biosciences appoints Susan Kim as CFO - Pacific Biosciences of California announced the appointment of Susan Kim as CFO, effective as of September 28, 2020. Kim brings twenty plus years of senior-level finance and operations experience to Pacific Biosciences, having most recently served as CFO for App Annie and Katerra.
|
NTP | Hot Stocks08:52 EDT Nam Tai Property CEO Ying Chi Kwok resigns - Nam Tai Property announced that Ying Chi Kwok has resigned as the director of board and CEO of the company due to personal reasons. Upon the resignation, Kwok ceases to be the chairman of the board. The resignation becomes effective immediately.
|
BKH | Hot Stocks08:47 EDT Black Hills Colorado gas subsidiary requests rate review - Black Hills Corp.'s Colorado natural gas utility, Black Hills Colorado Gas filed a rate review application with the Colorado Public Utilities Commission requesting $13.5M in new annual revenue to recover the investments made in its natural-gas infrastructure to serve customers. In a separate filing, as required by the Colorado commission, the company is also proposing a five-year system safety and integrity rider to recover the investment cost of maintaining the safety and integrity of the natural gas system. From July 2018 through year-end 2020, Colorado Gas will have invested over $105M in replacing, upgrading and expanding its natural gas system in the state. The 7,000 miles of natural gas transmission and distribution pipeline in Colorado provide the critical infrastructure required to meet the growing needs of its 192,000 Colorado customers. These investments have maintained safety and reliability by replacing aging infrastructure while meeting compliance requirements of state and federal regulations. As proposed, the rate review is requesting a capital structure of 50% percent equity and 50% percent debt and a return on equity of 9.95% for investments Colorado Gas made in its natural gas system. The company is seeking to implement new rates in the second quarter of 2021.
|
TRHC | Hot Stocks08:46 EDT Tabula Rasa HealthCare, Medplus Solutions form partnership for MedWise - Tabula Rasa HealthCare announces that Medplus Solutions, a pharmacy services provider in Puerto Rico, will deploy MedWise medication safety solutions for their long-term care clients. Additionally, Medplus will enhance their clinical pharmacy services by certifying their pharmacists as MedWise Advisors.
|
APA TOT | Hot Stocks08:43 EDT Apache provides update on Kwaskwasi-1 Discovery well offshore Suriname - Apache Corporation (APA) and Total S.A. (TOT) provided an update to the technical evaluation of the Kwaskwasi-1 discovery well offshore Suriname. As previously announced, Kwaskwasi-1 discovered hydrocarbons in multiple stacked targets in the upper Cretaceous-aged Campanian and Santonian intervals. The well encountered 278 meters of net oil and volatile oil/gas condensate pay. The shallower Campanian interval contains 63 meters of net oil pay and 86 meters of net volatile oil/gas condensate pay. The Santonian interval contains 129 meters of net pay. Fluid samples from the Campanian validated the presence of oil with API gravities between 34 and 43 degrees. Since the discovery announcement on July 29, 2020, the Noble Sam Croft drillship has gathered reservoir and other technical data in the Santonian. The company was able to successfully retrieve rotary sidewall cores but was unable to collect representative fluid samples from the reservoir due to conditions caused by cementing operations, which were required to mitigate increased pressure below the base of the Santonian formation. Hydrocarbon shows were observed in the Santonian reservoirs, and the results of the formation evaluation indicate the presence of oil. The Noble Sam Croft has commenced operations at the Keskesi East-1 exploration well approximately 14 kilometers southeast of Sapakara West-1. The Keskesi well will test upper Cretaceous targets in the Campanian and Santonian. Apache holds a 50% working interest in Block 58 and will continue to be the operator through the completion of the Keskesi well. Total S.A. holds the remaining 50% working interest.
|
CLCT | Hot Stocks08:41 EDT Collectors Universe expands board of directors to eight members - Collectors Universe announced that its Board of Directors has implemented a significant refreshment through the appointment of three new, highly qualified independent directors. The new directors have been appointed effective immediately, expanding the Collectors Universe Board from five to eight members, seven of whom are independent. The new directors are: Kate Duchene, CEO of RGP, Vina Leite, CPO at The Trade Desk and Jon Sullivan, EVP and CFO of Behr Paint Company.
|
PK | Hot Stocks08:39 EDT Park Hotels & Resorts reopened 14 hotels since June, provides business update - Thomas Baltimore, Jr., Chairman and CEO, stated, "I am extremely pleased with the progress we have made on many fronts as we continue to navigate this crisis. Over the past couple of months, we have opened additional hotels and experienced better than expected results through July and August, and we have begun to quantify and execute on cost-savings initiatives as we work with our operating and brand partners to reposition the operating model. Additionally, we have completed an amendment process with our lending partners to extend our revolving credit facility by two years, further improving our liquidity position and providing us additional flexibility as we look to turn the corner and pursue opportunities as they develop in the coming months. I would like to personally thank all of our partners and stakeholders for their efforts in support of Park as we weather this global pandemic." The company provided the following highlights: "Reopened 14 hotels since June, increasing the total number of hotels open to 46 of 60 hotels (77%), or 59% of total room count; Occupancy improved to 32.3% for Park's 33 consolidated hotels open during the entirety of July and 38.8% for Park's 37 consolidated hotels open during the entirety of August; Initiated permanent property-level full-time staff reductions, representing expected future annual savings of $50 million to $70 million throughout the portfolio based on 2019 operations; continuing its efforts to remove costs from the hotel operating model; Agreed to an increase in aggregate commitments under the revolving credit facility and near-term liquidity by $75 million to $1.075 billion and agreed to extend $901 million of the aggregate commitments for two years to December 2023; and Agreed to amend its bank credit facilities to obtain additional financial covenant relief and increase its carve out for acquisitions funded with equity proceeds from $500 million to $1 billion, among other amended provisions."
|
LPRO | Hot Stocks08:39 EDT Open Lending signs Sound Credit Union to Lenders Protection Program - Open Lending Corporation announced that Sound Credit Union, a $2.1 billion institution based in Tacoma, WA, has signed with Open Lending to implement their Lenders Protection program.
|
MRMD | Hot Stocks08:38 EDT Marimed to commence adult use operations at Panacea Wellness Dispensary - MariMed announced that the Massachusetts Cannabis Control Commission completed its final inspection and has authorized MariMed's Panacea Wellness Dispensary in Middleborough, Massachusetts to commence adult-use retail sales which it has scheduled to begin on Monday, September 14th. Panacea Wellness has been open under the Massachusetts Medical Cannabis Program since December of last year. Panacea Wellness will now be open to sell cannabis flowers and products to all customers over 21 years of age in compliance with the Massachusetts Adult Use Cannabis Program. Entry into the adult-use market significantly expands MariMed's addressable market in Massachusetts and is expected to drive revenue growth in the last two quarters of 2020 and into 2021.
|
MDGS | Hot Stocks08:37 EDT Medigus says ScoutCam upgrades to OTCQB Venture Market - Medigus announced it was informed by ScoutCam, Medigus' subsidiary and a leading developer and manufacturer of customized visual solutions and supplementary technologies, that ScoutCam has been upgraded to the OTCQB Venture Market.
|
ACRX | Hot Stocks08:37 EDT AcelRx announces Dsuvia added to DoD JDF - AcelRx announced that the U.S. military's access to Dsuvia has been expanded with the addition of Dsuvia to the Department of Defense's, or DoD, Joint Deployment Formulary, or JDF. The JDF is a core list of pharmaceutical products that are designated for deploying military units across all service branches.
|
AYLA | Hot Stocks08:36 EDT Ayala Pharmaceuticals to host KOL event on Phase 2 ACCURACY trial data - Ayala Pharmaceuticals announced that it will host a virtual Key Opinion Leader event to review new interim data presented from the ongoing Phase 2 ACCURACY study of AL101 for the treatment of recurrent/metastatic adenoid cystic carcinoma harbouring Notch activating mutations at the European Society for Medical Oncology Virtual Congress 2020. The event will take place on Friday, September 18, 2020 at 8:00 am ET. The event will feature presentations from Ayala management and KOL, Dr. Alan L. Ho, M.D., Ph.D., Medical Oncologist at Memorial Sloan Kettering Cancer Center and a lead investigator in the ACCURACY trial.
|
MYOV | Hot Stocks08:35 EDT Myovant Sciences presents data from Phase 3 LIBERTY Program, observational study - Myovant Sciences announced the presentation of one-year data on bone mineral density from the Phase 3 LIBERTY program evaluating the safety and efficacy of once-daily relugolix combination therapy in women with uterine fibroids. The BMD results from the LIBERTY program demonstrated maintenance of BMD through one year and were consistent with those observed in a separate prospective observational study of untreated, age-matched women with uterine fibroids. The findings were presented at the American Society for Bone and Mineral Research 2020 Annual Meeting Virtual Event, held September 11-15, 2020. Details of the presentations are as follows: Relugolix Combination Therapy Preserves Bone Mass in Patients with Uterine Fibroids: Results from Phase 3 LIBERTY Program: The Phase 3 LIBERTY program evaluated the safety and efficacy of once-daily relugolix combination therapy in premenopausal women with heavy menstrual bleeding due to uterine fibroids. The program met its primary endpoints and demonstrated that relugolix combination therapy significantly reduced menstrual blood loss and pain. In this analysis, pooled data from 768 women in the LIBERTY 1 and LIBERTY 2 studies showed that mean changes in lumbar spine bone mineral density were comparable for relugolix combination therapy and placebo. Evaluation of Relugolix Combination Therapy to Maintain Bone Mass in Women with Uterine Fibroids Through 52 Weeks: LIBERTY Long-Term Extension Study: Eligible women who completed the LIBERTY 1 or LIBERTY 2 studies were offered the opportunity to enroll in an active treatment extension study in which all women received relugolix combination therapy for an additional 28-week period, for a total treatment period of up to 52 weeks. In this analysis, data from 163 women who entered the extension study after receiving 24 weeks of relugolix combination therapy demonstrated maintenance of BMD through 52 weeks of treatment. A Prospective Observational Study of Bone Mineral Density in Premenopausal Women with Uterine Fibroids: This prospective observational study was designed to characterize longitudinal BMD in 262 premenopausal women with uterine fibroids. Mean LS BMD showed minimal changes over the 52-week observational period. Relugolix combination tablet is under review by the U.S. Food and Drug Administration for the treatment of women with uterine fibroids, with a target action date of June 1, 2021. Myovant submitted a Marketing Authorization Application to the European Medicines Agency in March 2020 for relugolix combination tablet in uterine fibroids. Additionally, 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. Myovant has also reported positive data from two replicate Phase 3 studies evaluating relugolix combination therapy in women with endometriosis.
|
PEP ACN | Hot Stocks08:34 EDT PepsiCo appoints Athina Kanioura as chief strategy and transformation officer - PepsiCo (PEP) announced that Athina Kanioura has been appointed executive VP and chief strategy and transformation officer. She will report to chairman and CEO Ramon Laguarta. In this new role, Kanioura will lead PepsiCo's end-to-end strategy to win both as a total company and in key markets, including the company's digitalization and data strategy. She will also lead company-wide transformation-ensuring that PepsiCo's scale is leveraged as the company focuses on accelerating growth and identifying areas of cost efficiency and optimization. Prior to joining PepsiCo, Kanioura was the chief analytics officer and global head of applied intelligence at Accenture (ACN), where she specialized in applying AI and analytics to drive business value.
|
ZIOP | Hot Stocks08:33 EDT Ziopharm granted rare pediatric disease designation for controlled IL-12 - Ziopharm Oncology announced that the U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation to Ad-RTS-hIL-12 with veledimex for the investigational treatment of diffuse intrinsic pontine glioma, a lethal brain tumor occurring in the pontine region of the brain. DIPG accounts for approximately 10 to 15 percent of all cases of brain tumors in children. The Rare Pediatric Disease Designation program is intended to encourage the development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.
|
BKYI | Hot Stocks08:30 EDT Partners in Health selects BIO-key PortalGuard Identity, Access Management - BIO-key International announced that Partners in Health selected BIO-key's PortalGuard Identity and Access Management solution to address their ongoing challenges with password resets and to improve authentication options to secure access to critical enterprise applications.
|
STAA | Hot Stocks08:30 EDT Staar Surgical reports completion of patient enrollment in EVO lens trial - STAAR Surgical Company announced that patient enrollment for the primary study analysis cohort of 300 subjects has been achieved in its U.S. FDA clinical trial, "A Multicenter Clinical Evaluation of the EVO/EVO+ Visian Implantable Collamer Lens." Primary study analysis will be conducted when 300 primary eyes complete 6 months of follow-up, which is anticipated early in the second quarter of 2021 with submission of the study results to the FDA shortly thereafter. "Completion of patient enrollment in the clinical trial is a critical step towards the future availability of our proprietary EVO Visian ICL family of products in the U.S. We are very grateful to our clinical trial sites and study investigators for their dedicated work and commitment to successfully achieving the trial's enrollment milestone in the midst of a challenging COVID-19 operating environment," said Caren Mason, President and CEO of STAAR Surgical. The objective of the U.S. pivotal study is to evaluate the safety, and to collect supportive data on effectiveness, of the EVO Visian ICLs in study participants who have a diagnosis of myopia or myopia with astigmatism.
|
BNGO | Hot Stocks08:29 EDT Bionano Genomics launches Lineagen EpiPanelDx PLUS gene panel test - Bionano Genomics announced the release of EpiPanelDx PLUS by its diagnostics services business, Lineagen. The new laboratory developed test and associated clinical support bolsters Lineagen's diagnostic services for physicians providing care for pediatric patients with neurodevelopmental disorders. EpiPanelDx PLUS is based on a proprietary panel of 223 genes associated with epilepsy-related conditions, more genes than typically found on epilepsy panels available from other service providers and customized for Lineagen's core market of neurodevelopmental disorders. Epilepsy refers to an array of neurological disorders characterized by involuntary seizures and affects approximately 1.2% of the population, or 3.4 million people, in the United States. It is frequently comorbid with other NDDs of childhood development, including intellectual disability and autism spectrum disorder and also can co-occur with neuro-behavioral disorders such as attention deficit hyperactivity disorder. Collectively, NDDs represent the most common form of developmental disorder with an estimated prevalence of 1 out of 6 children affected in industrialized countries. Lineagen's current menu of FirstStepDx PLUS chromosomal microarray and NextStepDx PLUS whole exome sequencing offers leading molecular diagnostic tests designed to help pediatricians and pediatric neurodevelopmental specialists manage their patients with NDDs. Offering such physicians a test for epilepsy allows Lineagen to more comprehensively serve their needs. EpiPanelDx PLUS is designed for patients who have experienced seizures, infantile spasms, encephalopathy, or febrile seizures, and has an expected 30% diagnostic yield. Lineagen also offers testing to the parents of the patients. By including the analysis of the genomes of one or both biological parents of the patient from the start, it is possible to increase the detection rate of disease-causing variants and inform on recurrence risk for the family. EpiPanelDx PLUS has been curated based on thorough literature review and includes genes with pathogenic variants identified in more than 2,000 epileptic patients tested by Lineagen. The use of a targeted gene panel such as EpiPanelDx PLUS fits the testing strategy that is recommended by the American Academy of Neurology and complements existing genetic tests offered by Lineagen such as FirstStepDx PLUS chromosomal microarray and NextStepDx PLUS whole exome sequencing, which are recommended for patients who show a wider array of neurological symptoms. To help tailor medical management, Lineagen also offers pharmacogenomic testing which includes certain genes that are responsible for the metabolism of important anti-epileptic or anticonvulsant drugs prescribed for epilepsy.
|
OR | Hot Stocks08:27 EDT Osisko Gold provides update on Stornoway Renard mine - Osisko Gold Royalties announced that, following a thorough review of operations and the establishment of a detailed restart plan, the Renard diamond mine, operated by Stornoway Diamonds Canada, will be restarting operations in September 2020. The detailed plan approved by the Board of Directors of Stornoway and its shareholders includes cost reductions of over $30M over the next 16 months of operations, with a projected impact of significantly reducing the all-in cost of production. Further to this cost reduction plan, the current shareholders of Stornoway have committed to reinvest up to $30M in a senior secured working capital facility. This additional commitment will provide the required financial flexibility for Stornoway to continue operating in a challenging diamond market. No initial drawdown is expected on the facility at this time as Stornoway currently has $10M in cash as well as approximately 332,000 unsold carats in inventory which it expects to sell later in 2020. The diamond market continues to be challenging, however, structural impediments to diamond sales are easing and increased demand has improved observed pricing for specific goods. Osisko holds a 9.6% diamond stream on the Renard mine and also became a 35.1% shareholder following the creditors' bid transaction which closed in November 2019. As part of the new commitment, the shareholders and streamers have agreed to continue deferring payments on their respective instruments until April 2022. Payments can be made prior to this date if the financial situation of Stornoway allows it.
|
LIFE | Hot Stocks08:26 EDT aTyr Pharma enters $20M common stock purchase agreement with Aspire Capital - aTyr Pharma announced that it has entered into a Common Stock Purchase Agreement providing for the sale of up to $20M of common stock to Aspire Capital Fund. Under the terms of the Agreement, Aspire Capital has committed to purchase up to $20 million of aTyr's common stock over a period of up to 30 months at prices based on the market price at the time of each sale, subject to certain terms and conditions. aTyr will control the timing and amount of any shares of common stock sold to Aspire Capital. There are no warrants, options, financing swaps, derivatives or other securities associated with this Agreement. aTyr retains the right to terminate the Agreement at any time, at its discretion, without any additional cost or penalty.
|
DAL | Hot Stocks08:25 EDT Delta Air Lines, SkyMiles IP to enter term loan for aggregate $6.5B - In a regulatory filing, Delta announced it is planning a private offering of senior secured notes in one or more tranches by Delta and SkyMiles IP Ltd., a newly formed exempted company incorporated with limited liability under the laws of the Cayman Islands and an indirect wholly-owned subsidiary of Delta, and to enter into a new senior secured term loan facility concurrently with the closing of the offering of the Notes. The aggregate principal amount of the Notes and the New Credit Facility is expected to be $6.5B. The Notes and the New Credit Facility will be guaranteed by certain of Delta's subsidiaries. SkyMiles IP Ltd. intends to lend the net proceeds from the offering of the Notes and the New Credit Facility to Delta, after depositing a portion of the proceeds in a reserve account. The final terms and amounts of the Notes and the New Credit Facility are subject to market and other conditions and may be materially different than expectations. Delta expects to use the proceeds of the Notes and New Credit Facility for general corporate purposes and to bolster its liquidity position.
|
XP | Hot Stocks08:24 EDT XP Inc. reduces pricing for online trading by eliminating stock brokerage fees - XP Inc. announced the elimination of brokerage fees for online stock trades at Rico, our online-only solution for self-directed investors, and a reduction of 75% at XP Direct for the same type of trades. In terms of the impact on XP's financials, Bruno Constantino, CFO, estimates a 2% reduction to total gross revenue based on Rico and XP Direct online equity trade revenues in 1H20. "We strongly believe that the long-term benefits to our ecosystem related to the reduction in fees will more than offset short-term financial impacts. As we saw when we successfully eliminated brokerage fees at Clear, we expect ongoing growing in Active Clients, their engagement and satisfaction and, consequently, a lower client acquisition cost. Furthermore, we understand that the initiative has potential to drive higher Net Inflows, AUC and cross selling opportunities across the platform to generate and grow other revenues. The strategic move will accelerate the disruption in the Brazilian financial markets led by XP, and while two million new individuals have joined the B3 over the past two years, we are still in the early stages of this. The Brazilian retail investor, with less than R$3 million, maintains around a 3% allocation to equities, which is very low. We believe that the ongoing equitization process in Brazil will accelerate and that number of individuals in the stock market could surpass 10 million in the next two to three years."
|
RCEL | Hot Stocks08:24 EDT AVITA Therapeutics enrolls first patient in RECELL System pivotal study - AVITA said in a release, "AVITA Therapeutics announced the initiation of the pivotal study assessing the use of the RECELL(R) System to treat stable vitiligo with the enrollment of the first patient at Miami Dermatology and Laser Institute in Miami, FL. The study will evaluate the safety and effectiveness of AVITA Therapeutic's RECELL System to repigment skin in patients who have vitiligo that has been stable for at least one year."
|
ATIF | Hot Stocks08:22 EDT ATIF Holdings signs strategic cooperation with Dexin Dahua Asset Management - ATIF Holdings announced that through its viable interest entity, Qianhai Asia Times International Finance Services Co. Ltd., it signed a strategic cooperation agreement with Shenzhen-based Dexin Dahua Asset Management Co. Ltd. on September 11, 2020. ATIF and Dexin Dahua will seek in-depth collaboration via the ATIF's recently launched online financial consulting service platform IPOEX.com. Pursuant to the Agreement, Dexin Dahua will serve as a channel for IPOEX to introduce and bring in different types of enterprises that could register as free and paid members on IPOEX. IPOEX shall provide all-encompassing consulting in corporate financing, initial public offerings and other project incubation services both online and offline. Dexin Dahua will also join as an institutional investor on IPOEX, to provide capital and fundraising-related services for member companies.
|
ALXN | Hot Stocks08:21 EDT Alexion, Caelum announce start of Phase 3 studies of CAEL-101 in AL Amyloidosis - Alexion Pharmaceuticals and Caelum Biosciences announced the initiation of the Cardiac Amyloid Reaching for Extended Survival, or CARES, Phase 3 clinical program to evaluate CAEL-101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care, or SoC, therapy in AL amyloidosis. The companies said in a release, "The CARES clinical program includes two parallel Phase 3 studies - one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease - and will collectively enroll approximately 370 patients globally. Enrollment is underway in both studies. The primary objective of the clinical program is to assess overall survival. The CARES clinical program consists of two parallel double-blind, randomized, event-driven global Phase 3 studies, which are evaluating the efficacy and safety of CAEL-101 in AL amyloidosis patients who are newly diagnosed and naive to standard of care, or SoC, treatment (cyclophosphamide-bortezomib-dexamethasone (CyBorD) chemotherapy). One study is enrolling approximately 260 patients with Mayo stage IIIa disease and one study is enrolling approximately 110 patients with Mayo stage IIIb disease. The studies will be conducted at approximately 70 sites across North America, the United Kingdom, Europe, Israel, Japan, and Australia. In each study, participants are being randomized in a 2:1 ratio to receive either CAEL-101 plus SoC or placebo plus SoC once weekly for four weeks. This will be followed by a maintenance dose administered every two weeks until the last patient enrolled completes at least 50 weeks of treatment. Patients will continue follow-up visits every 12 weeks. The primary study objectives are overall survival and the safety and tolerability of CAEL-101. Key secondary objectives will assess functional improvement in the six-minute walk test (6MWT), quality of life measures (Kansas City Cardiomyopathy Questionnaire Overall Score & Short Form 36 version 2 Physical Component Score) and cardiac improvement (Global Longitudinal Strain, or GLS)."
|
CANN | Hot Stocks08:21 EDT General Cannabis appoints Diane Jones as CFO - General Cannabis announced it has named Diane Jones as CFO. She becomes a member of the Company's senior management team as it expands its operations within Colorado and maintains a continued focus on creating and driving shareholder value across its business. Prior to joining General Cannabis Corp, Ms. Jones served as Corporate Controller for the Americas at Cardino. General Cannabis Corp also announced today a change in the composition of its Board of Directors, as its three independent Directors-Peter Boockvar, Mark Green and Seth Oster-have decided to step down after nearly a decade of collective service on the Board. The Board has elected Carl Williams, Richard Travia and Barker Dalton to replace Boockvar, Green and Oster. Williams, who will become Chairman of the Board and an independent director, has extensive company building experience, having lead private and public companies for over 30 years.
|
CODI | Hot Stocks08:18 EDT Compass Diversified appoints Katie Melzer as head of business development - Compass Diversified Holdings announced the appointment of Katie Melzer as Managing Director and Head of Business Development. Ms. Melzer will work closely with CODI's investment team to develop and maintain relationships with intermediaries across the country and work with CODI's existing subsidiaries to foster growth through opportunistic acquisitions. Prior to joining CODI, Ms. Melzer spent more than 15 years at Robert W. Baird & Co., most recently serving as a Director in the Consumer Investment Banking group.
|
MDXG | Hot Stocks08:18 EDT MiMedx launches EpiCord Expandable Placental Allograft - MiMedx Group announced the launch of EpiCord Expandable, the latest advancement in its portfolio of products. At the core of this technology is EpiCord, which has demonstrated clinical efficacy in the treatment of diabetic foot ulcers. The patent-pending design of EpiCord Expandable allows the allograft to cover up to twice the surface area once expanded. This new placental tissue allograft provides healthcare professionals an additional option to support the advanced wound care needs of their patients with larger, chronic, and hard-to-heal wounds.
|
SUPN | Hot Stocks08:17 EDT Supernus submits NDA for SPN-830 for treatment of ON-OFF episodes - Supernus announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for its apomorphine infusion pump for the continuous treatment of ON-OFF episodes in adults with Parkinson's disease whose motor control is unsatisfactory with oral levodopa and at least one other noninvasive PD therapy. The NDA for SPN-830 is based on data from an extensive development program, completed by Supernus' partners, US WorldMeds, LLC and Brittania Pharmaceuticals Ltd. The program includes the TOLEDO study, a pivotal Phase III study and a supportive safety and efficacy study. TOLEDO was a Phase III, multi-center, double-blind, placebo-controlled study that investigated the efficacy and safety of apomorphine subcutaneous infusion in PD subjects whose motor fluctuations were not adequately controlled on optimized treatment. The US study is an open label study which investigated the safety and effectiveness of SPN-830. The study eligibility criteria, apomorphine administration and dosing, study schedule, and efficacy and safety measures in both studies were similar. Both studies included PD subjects with average daily OFF time greater than or equal to3 hours. The primary efficacy endpoint in both studies was the change from baseline to Week-12 in mean daily OFF time over 24 hours recorded by the subject in a motor symptom diary. In TOLEDO, the reduction in mean daily OFF time with SPN-830 in comparison with placebo was statistically significant. In the US study, mean daily OFF time decreased from baseline to Week-12 by 3.0 hours. Most of the treatment-related adverse events were mild or moderate in severity. Infusion site AEs, nausea and dyskinesia were the most frequently reported AEs related to study treatment.
|
JKS | Hot Stocks08:15 EDT JinkoSolar supplies Trung Nam Group with 611MW of Tiger modules - JinkoSolar announced that it has supplied Trung Nam Group with 611MW of Tiger bifacial transparent backsheet modules, which were installed at the Thuan Nam solar power plant project in Vietnam. Located in Thuan Nam, the Thuan Nam solar power plant project is one of the largest solar power projects by capacity that are using bifacial modules in both Vietnam and Southeast Asia. The Tiger series modules utilize half-cell technology and incorporated tiling ribbon technology into the cell design to improve shading tolerance and eliminate any inter-cell gap to ensure high reliability and high efficiency. Tiger bifacial modules with transparent backsheet technology are able to generate higher power compared with conventional modules and reduce the levelized cost of electricity, or LCOE. Apart from these competitive advantages, the Tiger 163mm wafer size modules are able to generate 20W-25W more power than the 166mm modules and save more on Balance of System cost. Tiger modules are also suitable for projects with land scarcity challenges as they are smaller in size compared with 166mm modules. In addition, the Tiger bifacial transparent backsheet modules are about the same weight as mono-facial modules and are much lighter than conventional bifacial modules, which will help to save on logistics and labor costs for installation.
|
VYNE | Hot Stocks08:14 EDT VYNE Therapeutics appoints Patrick LePore to board of directors - VYNE Therapeutics appointed Patrick LePore to serve as a director of the Company, effective as of September 10, 2020. He served as Chairman, CEO and President of Par Pharmaceutical Companies, Inc. from September 2006 to 2012.
|
CTL | Hot Stocks08:12 EDT CenturyLink to change name to Lumen Technologies - CenturyLink has a new brand name. As Lumen Technologies, or Lumen, the company will aim to lead enterprises through the challenges and opportunities of the 4th Industrial Revolution, a time when smart, connective devices are everywhere. The company said, Lumen brings a new focus to how it views the marketplace and the world with the purpose to further human progress through technology. The company does not intend to change its financial strategy or financial reporting as a result of this announcement. Effective with the opening of the trading day on September 18, the company stock ticker will change from CTL to LUMN. The legal name of CenturyLink is expected to be formally changed to Lumen Technologies upon the satisfaction of all legal and regulatory requirements.
|
MYRG | Hot Stocks08:11 EDT MYR Group awarded construction contract with LS Power Grid NEw York - MYR Group announced it has executed a contract with LS Power Grid New York Corporation I, an affiliate of LS Power, to provide procurement and construction services for the Marcy to New Scotland Upgrade Project in the State of New York. The project consists of nearly 100 miles of 345-kilovolt transmission construction within existing utility corridors. The contract is valued at more than $250M. Under the contract, MYR Group will provide project management, construction management, material procurement, and construction services including right-of-way clearing, environmental controls, foundation installation, structure assembly and erection and conductor stringing. Construction planning has begun, and construction is expected to begin in early 2021 with a scheduled in-service date by the end of 2023.
|
SSKN | Hot Stocks08:10 EDT Strata Skin Sciences announces new direct distribution contract with JMEC Co. - STRATA Skin Sciences announced the signing of a new direct distribution contract with JMEC Co., Ltd. which now provides for a combination of direct recurring revenue from placements and direct capital sales in Japan. Contract Highlights: Strengthens the STRATA XTRAC and VTRAC brand value proposition in Japan to expand the installed base of over 300 devices in-country. Takes advantage of STRATA's strong balance sheet to support the unique recurring revenue business model, now in Japan. Leverages the over 15-year relationship with JMEC, a preeminent medical device distributor active in Japan since 1995, distributing and providing support for STRATA Excimer devices since 2005. The treatment by 308nm Excimer is covered by Japan's national health insurance with reimbursement rates of $33 per procedure. Provides a strategy to target the over 12,000 dermatologists in Japan with an enhanced and unique business proposition never before seen in the Japanese clinical dermatology market. STRATA expects to see the impact of the recurring revenue business model in Japan as early as the end of 2020.
|
BBBY | Hot Stocks08:09 EDT Bed Bath & Beyond appoints Juan Guerrero as chief supply chain officer - Bed Bath & Beyond has appointed Juan Guerrero as senior VP, chief supply chain officer, effective immediately. Guerrero will report directly to COO and president of buybuy BABY, John Hartmann, and be responsible for leading the transformation and optimization of the company's global supply chain network. Guerrero will lead Bed Bath & Beyond's work to reconstruct and modernize supply chain operations as it further improves the omni-always shopping experience for customers. This will include supporting strategic sourcing and the introduction of an array of owned brands. Guerrero will lead a cross-functional team to improve the company's logistics proficiencies and rebuild supply chain infrastructure systems, while leveraging data and analytics. Prior to joining Bed Bath & Beyond, Guerrero led the supply chain and merchandising teams at FleetPride.
|
FBIO ALXN | Hot Stocks08:09 EDT Fortress Biotech initiates Phase 3 studies of CAEL-101 - Fortress Biotech (FBIO) announced that Caelum Biosciences, in collaboration with Alexion Pharmaceuticals (ALXN), initiated the Cardiac Amyloid Reaching for Extended Survival Phase 3 clinical program to evaluate CAEL-101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care therapy in AL amyloidosis. In 2019, Caelum, a company founded by Fortress, entered into a collaboration agreement with Alexion under which Alexion acquired a minority equity interest in Caelum and an exclusive option to acquire the remaining equity in the company based on Phase 3 CAEL-101 data. Fortress maintains a 40 percent ownership in Caelum's issued and outstanding stock and is eligible to receive approximately 43 percent of the proceeds from an Alexion acquisition option exercise. The CARES clinical program includes two parallel Phase 3 studies - one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease - and will collectively enroll approximately 370 patients globally. Enrollment is underway in both studies. The primary objective of the clinical program is to assess overall survival. AL amyloidosis, also called primary amyloidosis, is a rare disease that occurs when an abnormal protein called amyloid builds up in organs and interferes with their normal function. It affects many organs, including the heart and kidneys, causes significant damage and impairs organ function. Median survival in patients with AL amyloidosis that has affected the heart is less than a year following diagnosis.
|
ONEW | Hot Stocks08:09 EDT OneWater Marine: Revenue up in excess of 20% QTD - Based upon preliminary financial information for the quarter-to-date ended August 31, 2020, OneWater estimates that revenue increased in excess of 20% and consolidated same-store sales increased in excess of 17% compared to the same period in the prior year. In addition, the company has also achieved a solid improvement in gross margins in the fiscal fourth quarter-to-date period ended August 31, 2020, over the prior year comparable period.
|
BAESY LMT | Hot Stocks08:07 EDT BAE Systems awarded contract from Lockheed Martin - BAE Systems (BAESY) said in a release, "BAE Systems has been awarded a contract from Lockheed Martin (LMT) for the production and delivery of additional electronic warfare, or EW, systems for Lot 15, Lot 16 long lead, sustainment spares and retro fit kits for the 5th Generation F-35 Lightning II, providing advanced situational awareness and threat response capabilities that support critical missions in contested airspace. The contract follows BAE Systems' production and delivery of more than 500 EW systems for the F-35 as a key system partner, matching Lockheed Martin's airframe production. BAE Systems supports all stages of the product's lifecycle, from development and production to sustainment. The company is actively designing and developing new capabilities to enhance the system's offensive and defensive capabilities, and maintains its readiness for warfighters under a performance-based logistics sustainability contract."
|
AVDL FTSV | Hot Stocks08:07 EDT Avadel Pharmaceuticals CMO Jordan Dubow to depart - Avadel Pharmaceuticals (AVDL) announced that Jordan Dubow, M.D. will be stepping down as CMO to pursue another opportunity. He will continue in a consultancy role in order to support the Company through the filing, review and anticipated approval of the new drug application for FT218 with the FDA. Mark McCamish, M.D., Ph.D., an Independent Director on Avadel's Board of Directors, will assume a direct leadership role for the FT218 filing working with Avadel CEO Greg Divis, Dr. Dubow and the rest of the team to ensure continuity of the FT218 program, including the completeness and timeliness of the NDA submission. McCamish, who joined the Avadel Board of Directors in December 2019, is an internationally recognized expert in drug development, regulatory affairs and manufacturing. Most recently, he was the President and CEO of Forty Seven (FTSV).
|
VZ | Hot Stocks08:05 EDT Verizon enters agreement with American Movil to acquire Tracfone - Verizon announced that it has entered into an agreement with America Movil to acquire Tracfone, the leading pre-paid and value mobile provider in the U.S. The acquisition expands Verizon's portfolio into the value segment, bringing enhanced access to its industry-leading wireless network and comprehensive suite of mobility products and services to a new customer base. Tracfone is the largest reseller of wireless services in the US, serving approximately 21 million subscribers through a network of over 90,000 retail locations nationwide. A longtime partner of Verizon, more than 13 million Tracfone subscribers currently rely on Verizon's wireless network through an existing wholesale agreement. Following the acquisition, Verizon expects to bring its award-winning 4G LTE and 5G networks and other innovative technologies to Tracfone customers, further develop Tracfone's distribution channels, and expand Tracfone's market opportunities.The acquisition of Tracfone aligns with Verizon's growth oriented Network as a Service strategy, and will provide more U.S. consumers seeking value wireless plans with improved experiences and enhanced services, including fixed wireless residential broadband solutions, 5G access and expanded international calling and roaming options. The portfolio of Tracfone brands creates a platform for growth and innovation in Verizon's support of the value and low income segments. Verizon will continue to offer Lifeline service through Tracfone and further develop its core brands, products and distribution channels, including StraightTalk, the vast majority of whose customers operate on the Verizon network. The consideration for the transaction will include $3.125 billion in cash and $3.125 billion in Verizon common stock, subject to customary adjustments, at closing. The agreement also includes up to an additional $650 million in future cash consideration related to the achievement of certain performance measures and other commercial arrangements.Verizon expects to drive significant benefits and network synergies from the transaction. Verizon expects the transaction to be accretive in the first full year following closing, excluding transaction and integration costs, and does not expect the transaction to materially impact capital expenditures. The transaction is subject to receipt of regulatory approvals and other customary closing conditions. Verizon expects the transaction to close in the second half of 2021.
|
CNTY | Hot Stocks08:05 EDT Century Casinos announces reopening of live table games in casinos - Century Casinos announced that it successfully reopened live table games at Century Casino and Hotel in Edmonton, Canada; Century Casino Calgary, Canada; Century Casino St. Albert, Canada and Century Casino and Hotel Central City, Colorado, between September 7 and September 11.
|
MRNS | Hot Stocks08:04 EDT Marinus Pharmaceuticals awarded BARDA contract - Marinus Pharmaceuticals said in a release, "Marinus Pharmaceuticals announced it has entered into a five-year development contract with the Biomedical Advanced Research and Development Authority, or BARDA, part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, to support the development of IV ganaxolone for the treatment of refractory status epilepticus, or RSE, a life-threatening condition in which a significant number of patients do not respond to first- and second-line anticonvulsant drugs. RSE can occur as a result of a variety of serious, acute medical conditions or after exposure to nerve agents. The agreement covers a base period during which BARDA will provide subject matter expertise and $21 million to fund, on a cost share basis, the company's planned Phase 3 clinical trial of ganaxolone for the treatment of RSE (as a result of an underlying medical condition) and will fund preclinical studies of ganaxolone in nerve agent exposure animal models. Contingent on favorable clinical and preclinical outcomes in the base period, the contract includes up to approximately $30 million of additional BARDA funding spanning three options in support of manufacturing, supply chain, clinical, regulatory and toxicology activities. Under the contract, Marinus will be responsible for cost-sharing in the amount of $33 million if all development options are completed. On a successful development, BARDA and Marinus may negotiate a procurement agreement for a supply of ganaxolone for potential response to nerve gas exposure threats. Marinus plans to pursue further discussions with BARDA to evaluate additional routes of administration for ganaxolone that would support field-based rapid response treatment in the event of a nerve gas attack."
|
ATIF | Hot Stocks08:04 EDT ATIF Holdings signs strategic cooperation agreement for IPOEX platform - ATIF Holdings announced that through its viable interest entity, Qianhai Asia Times, it signed a strategic cooperation agreement with Shenzhen-based Dexin Dahua Asset Management. ATIF and Dexin Dahua will seek in-depth collaboration via ATIF's recently launched online financial consulting service platform IPOEX.com. Pursuant to the agreement, Dexin Dahua will serve as a channel for IPOEX to introduce and bring in different types of enterprises that could register as free and paid members on IPOEX. IPOEX shall provide consulting in corporate financing, initial public offerings and other project incubation services both online and offline. Dexin Dahua will also join as an institutional investor on IPOEX, to provide capital and fundraising-related services for member companies.
|
VXRT | Hot Stocks08:03 EDT Vaxart announces FDA clearance of IND application for oral COVID-19 vaccine - Vaxart announced that the U.S. Food and Drug Administration has completed its review of the Company's Investigational New Drug application for its Phase 1 clinical trial evaluating its oral COVID-19 vaccine candidate. The Company also provided an update on its COVID-19 program. The Phase 1, open-label, dose-ranging study will be conducted in healthy adults ages 18 to 55 years old. The study's primary objective is to examine the safety and reactogenicity of two-doses of the vaccine. Secondary objectives include immunogenicity, duration of immune response and occurrence of symptomatic COVID-19. Vaxart is conducting a SARS-CoV-2 challenge study in hamsters to provide efficacy data and insights into the optimal dose regimen of our vaccine candidate. Results from this study, which began in early August, are expected mid-October. In addition, and as previously disclosed, Vaxart is awaiting results from a non-human primate challenge study that is testing its vaccine in a harmonized protocol as part of Operation Warp Speed. This preclinical program is being conducted in collaboration with the Biomedical Advanced Research and Development Authority and other entities working with Operation Warp Speed.
|
PLAB | Hot Stocks08:01 EDT Photronics announces $100M share repurchase program - Photronics announced that its Board of Directors has authorized the repurchase of up to $100M of its common stock. The purchases will occur pursuant to a new repurchase plan under SEC Rule 10b5-1.
|
LX | Hot Stocks07:53 EDT LexinFintech announces management share purchase plan - LexinFintech Holdings announced that members of its senior management, including chairman and CEO Jay Wenjie Xiao, president Jared Yi Wu, and other members of senior management, have informed the Company of their intention to use their personal funds to purchase up to an aggregate of $20M worth of the Company's American depositary shares within the next six months, pursuant and subject to applicable laws and the Company's securities trading policy. Each senior management member will make his or her own independent decision on the share purchase and its terms. The share purchases may be made from time to time in the open market at prevailing market prices, in privately negotiated transactions, in block trades and/or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations. Lexin's senior management team is confident in the Company's prospects and growth potential, and intends to purchase up to an aggregate of $20M worth of the Company's American depositary shares within the next six months as discussed above.
|
MTNB PLXP | Hot Stocks07:43 EDT Matinas BioPharma appoints Natasha Giordano to board of directors - Matinas BioPharma (MTNB) announced the appointment of Natasha Giordano to its Board of Directors as an independent director and a member of the audit committee, effective Monday, September 14, 2020. She has served as President, CEO, and a director of PLx Pharma (PLXP) since January 2016. The Company also announced that Adam Stern will not stand for re-election to the Company's Board of Directors at the Company's Annual Meeting of Stockholders on November 2, 2020, instead transitioning to a consulting role where he will be available to the CEO and the Board of Directors on matters related to overall corporate and financial strategy.
|
AAU | Hot Stocks07:41 EDT Almaden Minerals announces exploration plans at Ixtaca property - Almaden Minerals reports on its intention to resume exploration in the area of the Ixtaca project. Since discovery with the first drill hole, exploration work at Ixtaca has been almost entirely focused on the discovery area, and this work has led to the silver and gold reserve which underpins the feasibility study, results of which were announced in December, 2018. The highlights of the FS, using base case prices of $1275/oz gold and $17/oz silver unless noted otherwise, include the following: Average annual production of 7.06 million ounces silver and 108,500 ounces gold over the first 6 years; After-tax IRR of 42% and after-tax payback period of 1.9 years; After-tax NPV of $310 million at a 5% discount rate; After-tax IRR of 57% at the highest upper case price deck of $1425/oz Au and $20/oz Ag; After-tax NPV of $466 million at the highest upper case price deck of $1425/oz Au and $20/oz Ag; Initial Capital of $174 million; Average LOM annual production of 6.14 million ounces silver and 90,800 ounces gold. All-in Sustaining Costs, including operating costs, sustaining capital, expansion capital, private and public royalties, refining and transport of $11.30 per silver equivalent ounce, or $850 per gold equivalent ounce; Elimination of tailings dam by using filtered tailings, which reduces the project footprint and water usage. Construction of a water reservoir providing a permanent and consistent long-term supply of water for residents. While it awaits the outcome of its permitting application and related processes, the Company has taken the decision to resume exploration at this large property with a focus on some previously identified high potential targets which lie outside of the currently defined reserve and feasibility study envelope. This program is starting with a desktop review of exploration data previously gathered, which is expected to lead to further field work in the near-term which may include mapping, surface sampling, geochemical stream silt and soil sampling, and geophysics. These data will be used to design a future drill program.
|
RVLGF | Hot Stocks07:38 EDT Revival drilling program 25% complete, third rig secured for Beartrack-Arnett - Revival Gold reports on the status of exploration and development activities at the Company's Beartrack-Arnett Gold Project located in Lemhi County, Idaho. Following a successful C$15 million equity financing in August, Revival Gold doubled its planned drilling program to 10,000 meters with two drill rigs covering four target areas. The Company today reports that the expanded drill program is now 25% complete and that a third drill rig will soon be mobilized. Meanwhile, Revival Gold's Preliminary Economic Study on the potential restart of heap leach operations at Beartrack-Arnett is progressing through trade-off studies and remains on track for completion and release by year end. 15 holes totaling approximately 2,450 meters have been completed this season to-date at the Haidee target at Arnett. Drilling to-date amounts to approximately 25% of the 10,000 meters of drilling planned for Beartrack-Arnett in the current program. Assay results from the first batch of drill holes this season are expected to be released by mid-October; A third Boart Longyear core drill rig has been secured and is due to arrive on site in late September. Drilling this year at Beartrack-Arnett will continue, weather and access dependent, through to the end of December; Revival Gold's geophysical contractor, Geofisica TMC, S.A. de C.V., arrived on site in late August. Twenty-one line-kilometers of gradient array induced polarization-resistivity geophysical survey has been completed at Arnett and the geophysical crew has moved on to initiate planned surveys at Beartrack; The program of geologic mapping and sampling at Arnett that commenced in July is expected to be completed by the end of September. The program has covered approximately 19 square kilometers to date. Over the past year, geologic work on the Arnett property has clarified several important geologic relationships including expanding Revival Gold's understanding of potential host rocks for gold mineralization and clarifying the structural model for the district. The result of this work has been the identification of new conceptual targets for potential future testing, and; The Beartrack-Arnett heap leach PEA is on track for completion and release by year-end. Wood plc, the principal consultant for the study, is completing trade-off studies this month. Trade-off study work has focused on trucking ore from Arnett to a heap leach pad at Beartrack, crusher configurations at Beartrack, mining equipment selection, and grade optimization in the early part of the mine life. Engineering work will now focus on completing capital and operating cost estimates and finalizing the project financial model.
|
KRG | Hot Stocks07:37 EDT Kite Realty Group collects over 89% of Q3 base rent, recoveries - As of September 11, 2020, KRG has collected over 89% of third quarter base rent and recoveries, exclusive of security deposits. An additional 2% of third quarter base rent and recoveries have been contractually deferred. Currently, September rent collections are on a similar pace to July and August.
|
IFRX | Hot Stocks07:35 EDT InflaRx initiates Phase III part of Phase II/III trial with IFX-1 - InflaRx announced today the start of the global Phase III part of its Phase II/III trial with IFX-1 in severe COVID-19 induced pneumonia with the initiation of the first clinical site in the Netherlands. In parallel, the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase III clinical trial in Germany. The randomized, double-blinded and placebo-controlled Phase III part of the Phase II/III trial plans to enroll approximately 360 early intubated, critically ill patients with COVID-19 induced pneumonia across sites in the US, EU, South America and other regions. Patients will be randomized 1:1 to receive either IFX-1 or placebo; all patients will receive standard of care. The primary endpoint will be 28-day all-cause mortality; key secondary endpoints will include assessment of organ support and disease improvement. An interim analysis is planned after enrollment of 180 patients, with a potential for an early stop for efficacy or futility. The data from the Phase II part of the study, which evaluated IFX-1 treatment plus best supportive care and best supportive care alone in 30 patients, have been accepted for publication in the peer-reviewed journal, The Lancet Rheumatology. IFX-1, which has recently been granted the International Nonproprietary Name, vilobelimab, currently has additional ongoing Phase II studies in ANCA-associated vasculitis and Pyoderma Gangraenosum and has completed Phase IIb development in Hidradenitis Suppurativa, for which a Phase III clinical development strategy is currently being developed.
|
MBRX | Hot Stocks07:34 EDT Moleculin Biotech to test WP1122 portfolio in COVID-19 animal model. - Moleculin Biotech announced that it has contracted with an independent laboratory to test the antiviral activity of its WP1122 portfolio in a COVID-19 animal model. Moleculin contracted with an independent laboratory for in vivo testing of its drug candidate, WP1122 and another candidate from the same portfolio in development as a possible treatment for COVID-19. The testing will involve that laboratory's hamster model and SARS-CoV-2. Based on the estimated start date of the study, final data may be available in December. Based on feedback from FDA, the company believes it may need to demonstrate activity in a COVID-19 animal model to successfully submit a request for IND status for WP1122. In addition, the company also continues to contract with independent labs to conduct additional in vitro studies, which are currently under way.
|
BIIB | Hot Stocks07:33 EDT Biogen to invest $250M in 20-year initiative to eliminate fossil fuels use - Biogen announced Healthy Climate, Healthy Lives, a groundbreaking $250M, 20-year initiative to eliminate fossil fuels across its operations and collaborate with renowned institutions with the aim to improve health, especially for the world's most vulnerable populations. The company said, "Building on its long-standing commitment to corporate responsibility, Biogen's goal is to eliminate its fossil fuel emissions by 2040, as well as be a catalyst for positive change by advancing the science around how fossil fuels impact human health and taking action to promote climate and health equity. Fossil fuel emissions drive the climate crisis and emit harmful air pollutants that are a leading cause of death around the globe,1 claiming nearly 9 million lives annually with the greatest toll on the most vulnerable. Evidence shows that fossil fuel emissions play a direct role in the worsening of various health conditions, and emerging data suggests possible links to COVID-19 as well as brain health. It is Biogen's objective to advance the science in this area. With this announcement, Biogen becomes the first Fortune 500 company committing to become fossil fuel free across its operations by 2040." Healthy Climate, Healthy Lives has two principal components: Biogen intends to become fossil fuel free - to go beyond carbon neutrality by eliminating emissions on an accelerated timeframe. The company plans to: Power operations entirely by renewable energy by 2040. Support and encourage suppliers to become fossil fuel free. Biogen's objectives include that 80 percent of suppliers commit to science-based targets by 2025 and that 50 percent source 100 percent of their electricity from renewable sources by 2030, expanding to 90 percent of suppliers by 2040. Transition its fleet of more than 1,500 vehicles to electric by 2025 and deploy infrastructure for workplace charging at more than 30 corporate locations. Establish new green chemistry targets by 2021, integrating these principles into all stages of therapy development by 2023. Biogen intends that all products achieve more than 90 percent of the green chemistry targets by 2030. Address fossil fuel-derived plastics by eliminating, minimizing or closed-loop recycling all plastics across all business functions and eliminating plastics in secondary and tertiary packaging by 2040. Actively support other institutions in their efforts to combat climate change by increasing investments in high-performing ESG companies and investment funds. Assist employees' ability to go fossil fuel free in their homes and enable them to invest in ESG options in eligible retirement plans. Biogen is collaborating with global leaders, including MIT and the Harvard T.H. Chan School of Public Health, to use data science and predictive analytics to drive strategies to mitigate environmental and health impacts from climate change as well as influence policy and improve health outcomes, particularly for the world's most vulnerable populations. The Healthy Climate, Healthy Lives initiative will be divided across two principal areas during a 20-year period: the company's operations, including employee benefits and related programs; and support of new collaborations. The initiative's funding will start in 2021.
|
CNSL | Hot Stocks07:31 EDT Consolidated Communications to receive up to $425M investment - Consolidated Communications announced that it has entered into an agreement with an affiliate of Searchlight, in connection with which affiliates of Searchlight have committed to invest up to an aggregate of $425M in the company. The investment has been unanimously approved by the Consolidated board. In connection with the investment from Searchlight, Consolidated will reduce net debt by $325M and launch a refinancing of substantially all of its remaining $2B of outstanding debt to extend debt maturities and enhance liquidity through an upsize in revolver capacity. As a result, Consolidated expects to have access to additional capital to accelerate fiber deployment and the company expects to reduce its net leverage ratio to 3.5x upon the receipt of the entire $425M investment. The company intends to use the proceeds from this investment to enhance its fiber infrastructure and accelerate investments in high-growth areas of its business. The first stage of the investment is not subject to any regulatory approvals and is expected to occur concurrently with the refinancing, subject to the satisfaction of customary conditions. The second stage of the investment is subject to certain regulatory approvals and other customary closing conditions. The parties expect to close the second stage of the investment in mid-2021, subject to satisfaction of these conditions.
|
EVLO | Hot Stocks07:30 EDT Evelo Biosciences appoints Julie Carretero as CPO - Evelo Biosciences announced the appointment of Julie Carretero as chief people officer. In her new role, Ms. Carretero will assume leadership responsibilities for people initiatives, including talent acquisition and employee development, and will be a member of the Evelo Leadership Team. Carretero joins Evelo from FXI Corporation, a private equity held manufacturing company, where she served as CHRO since 2018.
|
DAL | Hot Stocks07:29 EDT Delta Air Lines has parked approximately 40% of mainline fleet
|
DAL | Hot Stocks07:28 EDT Delta Air Lines doesn't intend to participate in CARES Act loan program - While Delta is eligible and entered into a non-binding letter of intent to the U.S. Department of the Treasury for $4.6B under the loan program, Delta has indicated it does not intend to participate in this program.
|
AOTVF | Hot Stocks07:28 EDT Ascot announces discovery of gold mineralization at Premier Gold Project - Ascot Resources announced the discovery of new high-grade gold mineralization at the "Day Zone" at the Company's Premier Gold Project. The high-grade intercepts are located 300m west from the planned underground development at Big Missouri. Mineralization is open along strike to the north and the south. The Day Zone is located on the Big Missouri Ridge, approximately 5 kilometres north of the Premier Mill. Additionally, an update is provided on Premier West. Highlights from the Day Zone include: 20.62g/t Au over 4.10m in hole P20-2212; 54.60g/t Au over 2.05m in hole P20-2213. As weather conditions improved in August, exploration was shifted to higher elevation targets at the Big Missouri Ridge after initial drilling was completed at Premier West. This news release summarizes the results from three drill holes at the Day Zone at Big Missouri and seven drill holes from Premier West. Exploration drilling at the Day Zone was prompted by anomalous soil geochemistry on the west side of the Big Missouri Ridge and sporadic drilling from the 1980s that indicated the presence of quartz breccia with associated gold mineralization. Drill pad Day-1 was established below the top of the ridge in order to test as much vertical extent as possible. A total of six drill holes were completed from this pad. All three drill holes intercepted gold mineralization at two different elevations with the best intercepts exceeding historical results in this area. These intercepts occur at a depth that appears to be equivalent to the well-established Big Missouri zone on the east side of the ridge. The first two holes intercepted impressive grades with visible gold in hole 2213. The drill core indicates that the area may be affected by structures that offset mineralization and possibly rotated structural blocks which may account for the different orientation compared to what is known from the eastern side of the ridge where mineralization dips gently to the west. Figure 2 shows a 300m gap between the Day Zone and the planned underground development at Big Missouri. Additional drilling will be necessary and is currently being planned to explore this area as well as the northern and southern strike extent of the high-grade zone. The potential for additional resources in this area appears to be very high. The Company reported drill results from drill pad PW-1 at Premier West pictured in news releases on July 29 and August 19. The results reported in those releases indicated the presence of high-grade mineralization to the west of Premier. The fences of drill holes from the one available drill pad followed the mineralization to the west by rotating the orientation of the drill holes. The westernmost drill holes suggest that the mineralized zone has a flatter dip than anticipated. The results summarized in Table 2 are believed to be from peripheral material to the established high-grade zone. Follow-up drilling will have to be conducted from a different drill pad that allows for drill holes perpendicular to the zone. The location of the planned drill pad PW-2 will have to be moved. Ascot is working to establish an alternative location and is hoping to conduct drilling before the end of the year.
|
DAL | Hot Stocks07:28 EDT Delta Air Lines sees September quarter capacity down approx. 60% y/y - For the September 2020 quarter, system capacity is expected to be down approximately 60% compared to the September 2019 quarter, with international capacity to be reduced approximately 80% and domestic capacity to be reduced approximately 50%. As a result of reduced demand expectations and lower capacity in the September 2020 quarter and beyond, Delta has parked approximately 40% of its mainline fleet, including the permanent retirement of certain aircraft. The company also said: "The impact of the pandemic on demand for air travel is also negatively affecting the performance of the SkyMiles loyalty program and its contribution to our financial results. Travel among SkyMiles members is consistent with Delta's overall travel patterns, as total miles redeemed in the first six months of 2020 declined by 78%. As a result, loyalty travel award revenue for Delta declined 59%, in line with the 60% decline in passenger revenue Delta reported for the first half of 2020. However, over the same period, cash received from sales to American Express declined by less than 5% year over year to $1.9 billion, as SkyMiles members continue to use co-brand cards."
|
NVRO | Hot Stocks07:25 EDT Nevro to establish manufacturing operations in Costa Rica - Nevro announced that it will establish global manufacturing operations in Costa Rica to invest in and support the company's future growth expectations. Nevro has entered into a 10-year lease for a 35,000 square foot manufacturing facility in Costa Rica. Total capital expenditures are expected to be approximately $11M from 2020-2023 with an additional $10M of implementation costs over the same period. The company expects the new manufacturing facility to be validated and approved in 2022, after which the company believes it will realize cost efficiencies and gross margin improvements from this initiative.
|
ATNM | Hot Stocks07:24 EDT Actinium Pharmaceuticals provides update on Actimab-A CLAG-M combination trial - Actinium Pharmaceuticals provided an update on the Actimab-A CLAG-M combination Phase 1 trial being conducted at the Medical College of Wisconsin, or MCW, in patients with Relapsed or Refractory, or R/R, Acute Myeloid Leukemia, or AML, age 18 and above who are fit for intensive therapy. All patients in the third dosing cohort, which was scheduled as the final cohort of the planned Phase 1 dose escalation trial, completed treatment with a 0.75 uCi/kg dose of Actimab-A followed by CLAG-M and have cleared their initial safety evaluation. Results from the planned portion of the Phase 1 trial including complete safety and efficacy data are expected to be presented by year end. Previously, it was reported that the second dose cohort demonstrated an 86% complete remission rate with 71% of patients achieving negative minimal residual disease status. Investigators at MCW have indicated that based on safety results thus far, they intend to expand the Phase 1 portion of the trial assuming FDA clearance. Dr. Mark Berger, Actinium's Chief Medical Officer, said, "We are excited that the planned portion of the Actimab-A CLAG-M trial has been completed and look forward to presenting results of the trial by year-end. The high rates of remission and MRD negativity with good tolerability seen in this trial thus far demonstrate the potential of our Antibody Radiation Conjugate (ARC) approach and the power of delivering radiation to a highly relevant target such as CD33, particularly in combination with other synergistic modalities. In the second dose cohort in this study, 0.50 uCi/kg of Actimab-A was administered, which was previously shown to be a subtherapeutic dose as a single agent. Despite receiving a subtherapeutic dose of Actimab-A, the second cohort in this study demonstrated an 86% complete remission rate, an improvement of nearly 60% over CLAG-M alone-implying mechanistic synergy. We look forward to the results of the full trial including the third cohort and a matured data set. If the trial continues to yield such strong results, we believe that the Actimab-A plus CLAG-M combination regimen will warrant further development as relapsed or refractory patients continue to have high unmet needs despite current treatments."
|
SAVA | Hot Stocks07:24 EDT Cassava Sciences announces results of Phase 2b study of sumifilam - Cassava Sciences announced final results of a Phase 2b study with its lead drug candidate, sumifilam, in Alzheimer's disease. In a clinical study funded by the National Institutes of Health, sumifilam significantly improved an entire panel of validated biomarkers of disease in patients with Alzheimer's disease. The ability to improve multiple biomarkers from distinct biological pathways with one drug has never been shown before in patients with Alzheimer's disease. Study results are expected to be published in a peer-reviewed publication. Sumifilam is the first of a new class of drug compounds that bind to a protein called Filamin A. In addition, Alzheimer's patients treated with sumifilam showed directional improvements in tests of remembering new information, versus patients on placebo. Improvements in cognition correlated most strongly with decreases in P-tau181, a biomarker that, when elevated, leads to tangles in the brain. Sumifilam decreased brain levels of Ptau-181 by 8-11%, versus placebo. In this study, Alzheimer's patients treated with 50 mg or 100 mg of sumifilam twice-daily for 28 days showed statistically significant improvements in biomarkers of disease pathology, neurodegeneration and neuroinflammation, versus Alzheimer's patients who took placebo. In addition, Alzheimer's patients treated with sumifilam showed directional improvements in validated tests of episodic memory and spatial working memory, versus patients on placebo. Cognitive improvements correlated most strongly with decreases in P-tau181. The study achieved a 98% response rate, defined as the proportion of study participants taking sumifilam who showed improvements in biomarkers. Phase 2b was a randomized, placebo-controlled, double-blind, multi-center clinical study of sumifilam. Sixty-four patients with mild-to-moderate Alzheimer's disease, age 50-85, were randomized to 100 mg or 50 mg oral sumifilam or matching placebo. Treatment was administered twice daily for 28 days. Nine U.S. study sites enrolled patients. A clinical diagnosis of Alzheimer's disease was confirmed with the Mini-Mental State Examination greater than or equal to16 to less than or equal to26 and a CSF T-tau/Abeta42 ratio greater than or equal to0.28. Safety was assessed by ECGs, clinical labs, adverse event monitoring and physical examinations. In this study, drug was safe and well-tolerated, with no drug-related patient discontinuations. The study used biomarkers to measure drug effects. Biomarkers are objective biological endpoints used to track the progression of Alzheimer's disease. Molecular aberrations in the brain are reflected in biomarkers found in cerebrospinal fluid, a fluid that surrounds the brain. A key objective of this study was to measure changes in levels of CSF biomarkers in study participants before and after 28 days of treatment. Key biomarker results include the following: Core markers of Alzheimer's pathology are total tau, phosphorylated tau, and amyloid beta42. In Alzheimer's, tau and P-tau levels are elevated and Abeta42 is low. T-tau decreased 15% for patients in the 50 mg drug group. T-tau decreased 18% for patients in the 100 mg drug group. P-tau decreased 8% for patients in the 50 mg drug group. P-tau decreased 11% for patients in the 100 mg drug group. Abeta42 increased 17% for patients in the 50 mg drug group. Abeta42 increased 14% for patients in the 100 mg drug group. Elevated CSF levels of two proteins, Neurogranin and Neurofilament Light Chain indicate neurodegeneration. Ng decreased 36% for patients in the 50 mg drug group. Ng decreased 43% for patients in the 100 mg drug group. NfL decreased 28% for patients in the 50 mg drug group. NfL decreased 34% for patients in the 100 mg drug group. Proinflammatory IL-6 is produced in response to tissue stress and injury. IL-6 decreased 10% for patients in the 50 mg drug group. IL-6 decreased 11% for patients in the 100 mg drug group. Elevated levels of neuroinflammatory marker YKL-40 indicate microglial activation. YKL-40 decreased 10% for patients in the 50 mg drug group. YKL-40 decreased 12% for patients in the 100 mg drug group. sTREM2 is a neuroinflammation biomarker that has commanded substantial recent attention from researchers for its role in Alzheimer's disease and frontotemporal dementia. sTREM2 decreased 43% for patients in the 50 mg drug group. sTREM2 decreased 46% for patients in the 100 mg drug group. A further objective of this study was to measure drug effects on cognition. Patients were tested at baseline and again on Day 28. Changes in episodic memory and spatial working memory were assessed on CANTAB, a validated, computer-based battery of tests. CANTAB is designed to measure cognitive skills regardless of the subject's language skills, speed, gender or education. Only directional trends are observed, due to limitations around study size. Key cognition results include: Alzheimer's patients in both drug groups showed directional improvements on tests of episodic memory and spatial memory after 28 days of treatment, versus patients on placebo. Effect Sizes were 46-17% versus placebo.Episodic memory improved by -5.7 for Alzheimer's patients in the 50 mg drug group, versus -1.5 for patients on placebo.Episodic memory improved by -4.3 for Alzheimer's patients in the 100 mg drug group, versus -1.5 for patients on placebo. Spatial memory improved by -1.6 for Alzheimer's patients in the 50 mg drug group, versus -0.4 for patients on placebo. Spatial memory improved by -3.3 for Alzheimer's patients in the 100 mg drug group, versus -0.4 for patients on placebo. Improvements in cognition correlated most strongly with decreases in CSF P-tau181, a biomarker that, when elevated, leads to tangles in the brain. Sumifilam decreased brain levels of Ptau-181 by 8-11%, versus placebo. CSF was drawn from all study participants by lumbar puncture, an outpatient procedure used to remove a small sample of CSF from the lower spine. Study participants underwent two CSF draws: before treatment started and again after 28 continuous days of treatment. All CSF samples were sent to outside labs for bioanalysis. Bioanalysis refers to a set of laboratory tests that detect and measure very small amounts of biomarkers in CSF. Bioanalyses were conducted under blinded conditions to eliminate any possibility of bias. An academic lab generated final results. The validity of final results is evidenced by robust correlations between biomarker movements over 28 days in the dataset for placebo samples, and only small changes in biomarkers in the placebo group, as expected. As previously disclosed, an initial bioanalysis by a different lab showed highly anomalous data, e.g., huge swings in levels of biomarkers, as well as biomarkers moving in opposite directions in the same patients, all in the group who took placebo for 28 days. With its validity in question, the initial bioanalysis serves no useful purpose. A small, well-controlled study of sumifilam showed promising treatment effects in patients with mild-to-moderate Alzheimer's disease. In this study, sumifilam treatment over 28 days improved an entire panel of validated biomarkers of Alzheimer's disease, decreased measurements of neuroinflammation, showed a 98% responder rate, appears safe and well-tolerated, and appears to benefit cognition. Importantly, the data are consistent with prior clinical and preclinical results, the drug's mechanism of action and over 10 years of basic research. Cassava Sciences is conducting an ongoing, long-term, open-label, multi-center, extension study of sumifilam 100 mg twice-daily for 12 months. The study's target enrollment is approximately 100 patients with mild-to-moderate Alzheimer's disease, including patients from prior studies of sumifilam. The open-label study is currently over 50% enrolled.
|
WMT | Hot Stocks07:20 EDT Walmart teams up with Zipline for U.S. drone delivery service - Walmart said in a statement: "We recently announced we're exploring how drones can deliver items in a way that's convenient, safe and fast. In our latest initiative, we are teaming up with Zipline to launch a first-of-its-kind drone delivery operation in the U.S. The new service will make on-demand deliveries of select health and wellness products with the potential to expand to general merchandise. Trial deliveries will take place near Walmart's headquarters here in Northwest Arkansas using Zipline's proprietary technology which is, simply put, really cool. Zipline will operate from a Walmart store and can service a 50-mile radius, which is about the size of the state of Connecticut. And, not only does their launch and release system allow for quick on-demand delivery in under an hour, but it also eliminates carbon emissions, which lines up perfectly with our sustainability goals. The operation will likely begin early next year, and, if successful, we'll look to expand."
|
USAS | Hot Stocks07:20 EDT Americas Gold and Silver announces increase to Galena Complex resource - Americas Gold and Silver, a growing North American precious metals producer, provides an update to its Mineral Reserve and Resource statement as at June 30. On a consolidated and attributable basis, estimated contained metal in the proven and probable mineral reserve categories totaled 610,000 ounces of gold, 30.6M ounces of silver, 134M pounds of zinc, 129M pounds of lead and 28M pounds of copper. Since the June 2019 Mineral Reserve and Resource statement, exploration drilling was focused solely at the Galena Complex as the company constructed and commissioned Relief Canyon. Drilling to date at the Galena Complex includes approximately 33% of planned exploration drilling based on the Galena Complex recapitalization plan. Based on this initial drilling at the Galena Complex, measured and indicated silver resources on a 100% basis increased from 27.4M ounces to 37.3M ounces and inferred silver resources increased from 39M ounces to 78.6M ounces. This represents a 36% and 101% increase, respectively, from previous reported estimates.
|
MATN | Hot Stocks07:17 EDT Mateon receives clearance for enrollment for study for Artemisinin Intervention - Mateon Therapeutics announced that its global study based on its ARTI-19 protocol for Artemisinin Intervention against COVID-19 has been cleared for patient enrollment in India. ARTI-19 in India is being conducted by Windlas as part of a co-development agreement between Windlas Biotech Private Limited and Mateon. The two companies executed an MOU on August 19, 2020 for the development and commercialization of Artemisinin as both a therapeutic pharmaceutical as well as herbal supplement against COVID-19. Windlas is a 20-year-old company with large scale manufacturing facilities in India employing more than 1500 employees and is the 5th largest Contract Development and Manufacturing Organization serving pharma companies across the world. The development of Artemisinin against COVID-19 is dependent on the successful completion of the ARTI-19 clinical trial "Artemisinin Intervention trial against COVID-19", which is being initiated globally in Africa, India, and South America. Windlas is Mateon's manufacturing partner for clinical trial and commercial product roll out.
|
CLGN | Hot Stocks07:17 EDT CollPlant signs distribution agreement for Vergenix FG in six CIS countries - CollPlant announced that it has signed an agreement for distribution of its Vergenix Flowable Gel, or FG, product in six Commonwealth of Independent States, or CIS, countries: Belarus, Kazakhstan, Georgia, Azerbaijan, Armenia and Uzbekistan. The company also reported that it has received the first order in an amount of hundreds of thousands of U.S. dollars. Based on deal terms, CollPlant will deliver a portion of the order immediately and the remainder over the next six months. The distributor is a Swiss-headquartered pharmaceutical group of companies and the agreement is for a five-year period. Vergenix FG is based on the Company's rhCollagen technology and is a wound-care product designed to treat acute and chronic hard-to-heal wounds, such as diabetic ulcers, pressure sores, surgical cuts and trauma wounds. A single application of the product provides an optimized treatment for the healing process until full wound closure.
|
EPIX | Hot Stocks07:14 EDT Essa Pharma announces fast track designation from FDA for EPI-7386 - Essa Pharma announced that the FDA granted fast track designation to EPI-7386, its oral and highly-selective N-terminal domain inhibitor of the androgen receptor, for the treatment of adult male patients with metastatic castration-resistant prostate cancer resistant to standard-of-care treatment.
|
NKLA | Hot Stocks07:13 EDT Nikola issues statement regarding Hindenburg Research report - Nikola issued the following statement commenting on report published by Hindenburg Research: "Nikola believes that the Hindenburg report, and the opportunistic timing of its publication shortly after announcement of Nikola's partnership with General Motors Co. and the resulting positive share price reaction, was designed to provide a false impression to investors and to negatively manipulate the market in order to financially benefit short sellers, including Hindenburg itself. Nikola has contacted and briefed the U.S. Securities and Exchange Commission (SEC) regarding Nikola's concerns pertaining to the Hindenburg report. Nikola intends to fully cooperate with the SEC regarding its inquiry into these matters... Short Seller Distorts Nikola One 2017 Third Party "Future of Transportation" Promotion Video and Creates a Popular Lie: Hindenburg seeks to portray Nikola as misrepresenting the capabilities of the Nikola One prototype in a 2017 video produced by a third party, as "simply filmed rolling down a big hill." Nikola never stated its truck was driving under its own propulsion in the video, although the truck was designed to do just that (as described in previous point). The truck was showcased and filmed by a third party for a commercial. Nikola described this third-party video on the Company's social media as "In Motion." It was never described as "under its own propulsion" or "powertrain driven." Nikola investors who invested during this period, in which the Company was privately held, knew the technical capability of the Nikola One at the time of their investment. This three-year-old video of a Nikola prototype is irrelevant except for the fact that the short seller is trying to use it for its main thesis. The fact is, Nikola has real working hydrogen fuel-cell powered semi-trucks. Any reports intended to suggest that Nikola's trucks do not drive are erroneous, and recent videos of Nikola vehicles driving can be found here. These allegations by the short seller are false and misleading, and designed to manipulate the market to profit from a manufactured decline in Nikola's stock price. Short Seller Intentionally Underestimates Extent of Hydrogen Production Capabilities: Nikola continues to believe that its planned hydrogen station network, and the production and distribution of hydrogen, will provide key competitive advantages that drive sustained profitability and shareholder value over the long term. Nikola representatives occupy leadership positions in industry organizations, including as working group chairs within the worldwide International Standards Organization (Heavy Duty) hydrogen fueling standard development and the Society of Automotive Engineers fuel cell standards committee for the HD vehicles' fuel economy. The Company has also partnered with one of the most well-known hydrogen experts in the world, Nel ASA. Further, Nikola has already installed a 1,000 kg hydrogen storage and dispensing demo station at its headquarters and ordered over $30 million of electrolyzers to support the initial hydrogen station rollout. Read more in the Company's press release. These allegations by the short seller are false and misleading, and designed to manipulate the market to profit from a manufactured decline in Nikola's stock price. Short Seller Alleges NZT Program Was Scrapped after Unveiling: The program remains underway. The first NZT enclosed cab display model is sitting in Nikola's showroom at its headquarters. The Company has since spent millions of dollars preparing the NZT enclosed cab version for production using both internal and external resources. More to come at Nikola World 2020. These allegations by the short seller are false and misleading, and designed to manipulate the market to profit from a manufactured decline in Nikola's stock price.Short Seller Quotes Spokesman of Fuel-Cell Competitor, Powercell AB, as Saying Nikola Battery and Hydrogen Fuel-Cell Technology is "Hot Air": Third-party competitor views of Nikola and the Company's technology are not relevant. These allegations by the short seller are false and misleading, and designed to manipulate the market to profit from a manufactured decline in Nikola's stock price. Short Seller Takes Shots at Nikola Employees: Nikola believes in talent, and each of the employees unfairly described in the short seller report are making important contributions to the success of the Company. Nikola has built a deep bench of experienced leaders, with significant expertise in the automotive and electric-vehicles industry. Kevin Lynk is a talented mechanical engineer who has specialized in computational fluid dynamics (CFD), finite element analysis (FEA), computer-aided design (CAD) and product data management (PDM). Kevin has also played an instrumental role in the design and development of most Nikola vehicles since the beginning of the Company. Travis Milton previously owned and operated his own construction company preparing him for hydrogen station infrastructure and buildouts. Dale Prows has over 30 years of experience in supply chain and purchasing in the petrochemical and aluminum industries. These allegations by the short seller are false and misleading, and designed to manipulate the market to profit from a manufactured decline in Nikola's stock price. Short Seller Misrepresents Value of 2010 Contract between Swift Transportation and dHybrid Systems LLC: This agreement was from 2010, and has no connection with or association to Nikola. In its report, Hindenburg criticizes Mr. Milton's statements about the approximately $250 million value of the contract between Swift Transportation and dHybrid (not Nikola), and cites only selected clauses to misrepresent the value of the contract as being worth "only $16 million." What Hindenburg fails to include are the provisions in the contract whereby Swift was granted an option to acquire up to an additional 11,700 systems at $20,000 per vehicle, bringing the total potential value of the contract to $250 million. The contract can be found here (see paragraph 6(b)). These allegations by the short seller are false and misleading, and designed to manipulate the market to profit from a manufactured decline in Nikola's stock price. There are dozens more inaccurate allegations made by the short seller, which are not relevant to Nikola..."
|
EGAN | Hot Stocks07:12 EDT eGain achieves FedRAMP "In Process" status - eGain announced that it has achieved "in process" status on the Federal Risk and Authorization Management Program Marketplace. The company is currently working with its sponsor, the Internal Revenue Service and the FedRAMP PMO to achieve FedRAMP Authorization.
|
AIV | Hot Stocks07:10 EDT Aimco to separate business into two public companies
|
AIV | Hot Stocks07:09 EDT Aimco announces formation of Apartment Income REIT, closing of $2.4B JV - Aimco said in a release, "Aimco announced its plan to separate its business into two, separate and distinct, publicly traded companies, Apartment Income REIT, or AIR, and Aimco. AIR, a newly formed, self-managed real estate investment trust will provide a simple and transparent way to invest in the multi-family sector: ownership with public market liquidity of a diversified portfolio of apartment communities, with low financial leverage, limited execution risk, best-in-class operations, and sector low management costs. Aimco will retain its growing business of developing and redeveloping apartment communities while also pursuing other accretive transactions. The decision was based on a longer-term strategic review by management and made through a highly engaged board process over the past several months. Bob Miller, Aimco Lead Director, thanked his colleagues for their long hours spent in numerous meetings to refine the concept of AIR as a "pure play" apartment investment vehicle and to refocus Aimco on its growing pipeline of development and redevelopment opportunities. "We came to understand deeply that today's Aimco includes two businesses: ownership with active management and development. We believe that both will benefit from separation with balance sheets tailored to the individual businesses, enhanced management focus, expanded opportunities, and distinctive risks and rewards for shareholders." Aimco also announced, as part of its longer-term strategy to reduce financial leverage and to rebalance its capital allocation among target markets, that it has entered into a ten-year joint venture with a passive institutional investor to own jointly 12 multi-family properties with 4,051 units located in California. The properties were valued at $2.4 billion, or approximately $592,000 per unit, equivalent to an implied NOI cap rate of ~4.2% and an implied free cash flow cap rate of ~4.0% (based upon NOI and free cash flow annualized for the six months ended June 30, 2020). The properties secure non-recourse property debt of $1.22 billion with a weighted average interest rate of 3.17% and have an implied equity value of $1.18 billion. In exchange for a 39% interest subject to $475 million of property debt, Aimco received $461 million cash plus an additional $24 million for future redevelopment spending. Aimco retains ownership of the remaining 61% interest and is responsible to operate the properties, earning property and asset management fees. The valuation is equal to 97% of the Gross Asset Value ("GAV"), as of 1Q20, previously calculated and published by Aimco."
|
SYBX | Hot Stocks07:08 EDT Synlogic appoints David Hava as chief scientific officer - Synlogic announced the appointment of David Hava as chief scientific officer. Hava will provide strategic leadership to the research organization and build Synlogic's portfolio of research partners. Hava is an experienced drug developer and CSO known for generating partnerships which build clinical and scientific value. He has previously served as chief scientific officer at Metera Pharmaceuticals.
|
DISH NOK | Hot Stocks07:06 EDT Dish selects Nokia 5G standalone Core software for U.S. 5G network - Nokia (NOK) announced that DISH Network (DISH) has chosen Nokia's cloud-native, standalone Core software products to help it build the most advanced, disruptive, fully-automated, cloud-native 5G network in the U.S. with high-level scale, performance, and efficiency. The deal follows months of joint testing as Nokia and DISH proved their respective "any cloud" capabilities in multiple cloud environments, along with Nokia's ability to integrate and deliver a fully cloud-native, containerized, end-to-end solution. The agreement includes subscriber data management, device management, packet core, voice and data core, as well as integration services. Nokia will also deliver additional cloud-native products that will provide 4G, 5G standalone and Voice over Wi-Fi access to core network functions. These products will provide DISH the speed, agility, intelligence, and security to deliver new 5G-era services, while cost-effectively managing its network with near zero-touch automation and adherence to Service Level Agreements.
|
REGN | Hot Stocks07:05 EDT Regeneron, Oxford RECOVERY trial to evaluate REGN-COV2 for COVID-19 patients - Regeneron and the University of Oxford announced that RECOVERY, one of the world's largest randomized clinical trials of potential COVID-19 treatments, will evaluate Regeneron's investigational anti-viral antibody cocktail, REGN-COV2. The Phase 3 open-label trial in patients hospitalized with COVID-19 will compare the effects of adding REGN-COV2 to the usual standard-of-care versus standard-of-care on its own. REGN-COV2 is the first specifically designed COVID-19 therapy being evaluated by RECOVERY. It was selected in part based on its emerging safety profile in humans, pre-clinical data showing it could protect against viral escape mutations, and prevention and treatment studies in non-human primates showing it reduced the amount of virus and associated damage in the lungs. REGN-COV2 is currently being studied in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals. The open-label RECOVERY trial will assess the impact of adding REGN-COV2 to the usual standard-of-care on all-cause mortality 28 days after randomization. Other endpoints include the impact on hospital stay and the need for ventilation. It is anticipated that at least 2,000 patients will be randomly allocated to receive REGN-COV2 plus usual standard-of-care, and results will be compared with at least 2,000 patients who receive standard-of-care on its own. Usual standard-of-care varies by local hospital.
|
ETNB | Hot Stocks07:05 EDT 89bio announces topline results from Phase 1b/2a trial of BIO89-100 - 89bio announced positive topline results from its Phase 1b/2a trial with BIO89-100, an investigational FGF21 analog, in patients with nonalcoholic steatohepatitis. All dose groups demonstrated significant reductions in liver fat at week 13, with relative reductions up to 60% versus baseline and up to 70% versus placebo, as measured by magnetic resonance imaging - proton density fat factor. A significant proportion of subjects responded to therapy with up to 88% and 71% of subjects achieving a greater than or equal to30% or a greater than or equal to50% reduction in liver fat versus baseline, respectively. Treatment with BIO89-100 also resulted in significant improvements in liver transaminases, with a 35 U/L decrease in ALT from baseline in subjects with elevated baseline levels, and reductions in ProC3, a marker of fibrosis. Importantly, BIO89-100 is the first FGF21 analog to show benefit in subjects with NASH with every two-week dosing. BIO89-100 was well tolerated at all doses with low incidence of adverse events that occurred in greater than or equal to10% of subjects and very low frequency of gastrointestinal events relative to placebo. BIO89-100 had a favorable safety and tolerability profile with no deaths or serious adverse events related to treatment. The frequency of GI events compared favorably to placebo with diarrhea and nausea being the only GI events occurring in greater than or equal to5% of BIO89-100-treated subjects. The only treatment-related adverse event that occurred in greater than or equal to10% of all BIO89-100-treated subjects was mild, increased appetite consistent with other investigational FGF21 analogs. No adverse effects on heart rate or blood pressure were observed. Treatment with BIO89-100 resulted in significant reductions in triglycerides, non-HDL and LDL-C. Triglycerides were reduced to a greater extent in subjects with elevated triglycerides at baseline, and 53% of the BIO89-100 subjects in this group normalized triglyceride levels versus 0% in the placebo group. BIO89-100 also demonstrated significant increases in the insulin-sensitizing hormone adiponectin. This study was a randomized, double-blind, placebo-controlled, multiple ascending dose-ranging trial in biopsy-proven NASH or phenotypical NASH subjects. A total of 81 subjects were randomized to receive weekly or every two-week dosing of BIO89-100 or placebo for up to 12 weeks. Key endpoints assessed were safety, tolerability, and PK of BIO89-100 as well as change in liver fat measured by MRI-PDFF and other metabolic markers.
|
ENTA | Hot Stocks07:03 EDT Enanta initiates Phase 1 clinical study of EDP-297 - Enanta Pharmaceuticals said in a release, "Enanta Pharmaceuticals announced that it has dosed the first subjects in its Phase 1 clinical trial of EDP-297, a highly potent and targeted follow-on farnesoid X receptor, or FXR, agonist, being developed for the treatment of non-alcoholic steatohepatitis, or NASH. The Phase 1, randomized, double-blind, placebo-controlled, first-in-human study is designed to assess the safety, tolerability, and pharmacokinetics, including the effect of food intake, of orally administered EDP-297 in approximately 74 healthy adult subjects. Two phases are planned: a single ascending dose phase enrolling six cohorts, including a two-part food effect cohort, and a multiple ascending dose phase enrolling three cohorts."
|
SLNCF ORTX | Hot Stocks07:02 EDT Silence Therapeutics appoints Mark Rothera as president, CEO - Silence Therapeutics (SLNCF) announces the appointment of Mark Rothera as President and CEO and Board member, effective immediately. Iain Ross, who has been Executive Chairman since December 2019, has assumed his previous position of Non-Executive Chairman. Prior to joining Silence, Mr. Rothera served as CEO of Orchard Therapeutics (ORTX), where he oversaw its transformation from a small U.K.-based, privately held company with two clinical-stage programmes into a leading gene therapy company with seven clinical-stage programmes and fully integrated capabilities.
|
TPX | Hot Stocks06:57 EDT Tempur Sealy provides business update - Tempur Sealy announced that quarter-to-date order trends have improved from previous expectations and the company now estimates total Q3 net sales to grow more than 30% compared to prior year. The change in expectation was primarily driven by improving order trends on U.S. Tempur-Pedic products. The company continues to experience capacity constraints for U.S. Sealy products, including supply chain limitations outside the Company's control. The company is working closely with suppliers to find solutions for component shortfalls to support the elevated U.S. Sealy demand. The company's board has approved the early termination of its shareholder rights plan to now expire at the close of business on September 14. The limited duration rights plan was adopted on March 27 with a previous expiration date of March 26, 2021. Shareholders are not required to take any action as a result of this expiration. The company also announced Cliff Buster will be promoted to the CEO of Tempur Sealy North America effective January 1, 2021.
|
NAV | Hot Stocks06:55 EDT Navistar issues statement regarding revised proposal from TRATON - Navistar issued a statement from its board regarding the revised proposal from TRATON SE. "Navistar's board, after careful consideration with the assistance of its financial and legal advisors, has unanimously concluded that while TRATON's revised proposal of $43.00 per share significantly undervalues the Company and substantial synergies from a combination, it does represent a starting point for further exploring the possibility of a transaction. TRATON has developed a strong strategic relationship with the Company in recent years, and, in light of the 23% increase in their proposal, the Board believes the best way for TRATON to appreciate the true value of a potential combination is to allow it to conduct due diligence and engage in further synergy discussions with the Company. Navistar does not intend to make any additional comments regarding the proposal, its engagement with TRATON, or the due diligence process unless and until it is appropriate to do so, or a formal agreement has been reached."
|
SGEN MRK | Hot Stocks06:55 EDT Merck to acquire $1B equity stake in Seattle Genetics as part of collaborations - Seattle Genetics (SGEN) and Merck (MRK) announced two new strategic oncology collaborations. The companies will globally develop and commercialize Seattle Genetics' ladiratuzumab vedotin, an investigational antibody-drug conjugate, or ADC, targeting LIV-1, which is currently in phase 2 clinical trials for breast cancer and other solid tumors. The collaboration will pursue a broad joint development program evaluating ladiratuzumab vedotin as monotherapy and in combination with Merck's anti-PD-1 therapy Keytruda in triple-negative breast cancer, hormone receptor-positive breast cancer and other LIV-1-expressing solid tumors. Under the terms of the agreement, Seattle Genetics will receive a $600M upfront payment and Merck will make a $1B equity investment in 5M shares of Seattle Genetics common stock at a price of $200 per share. In addition, Seattle Genetics is eligible for progress-dependent milestone payments of up to $2.6B. Separately, Seattle Genetics has granted Merck an exclusive license to commercialize Tukysa, a small molecule tyrosine kinase inhibitor, for the treatment of HER2-positive cancers, in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. Seattle Genetics will receive $125M from Merck as an upfront payment and is eligible for progress-dependent milestones of up to $65M. Under the terms of the agreement, Seattle Genetics and Merck will collaborate and equally share costs on the global development of ladiratuzumab vedotin and other LIV-1-targeting ADCs. The companies have agreed to jointly develop and share future costs and profits for ladiratuzumab vedotin on a 50:50 basis worldwide. Merck will pay Seattle Genetics $600M upfront and make a $1B equity investment in 5M shares of Seattle Genetics common stock at a price of $200 per share. In addition, Seattle Genetics will be eligible to receive up to $2.6B in milestone payments, including $850M in development milestones and $1.75B in sales milestones. The companies will jointly develop and commercialize ladiratuzumab vedotin and equally share profits worldwide. The companies will co-commercialize in the U.S. and Europe. Seattle Genetics will be responsible for marketing applications for approval in the U.S. and Canada, and will record sales in the U.S., Canada and Europe. Merck will be responsible for marketing applications for approval in Europe and in countries outside the U.S. and Canada, and will record sales in countries outside the U.S., Europe and Canada. Including the upfront payment, equity investment proceeds and potential milestone payments, Seattle Genetics is eligible to receive up to $4.2B. Under the terms of the agreement, Merck has been granted exclusive rights to commercialize Tukysa in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. Seattle Genetics retains commercial rights and will record sales in the U.S., Canada and Europe. Merck will be responsible for marketing applications for approval in its territory, supported by the positive results from the HER2CLIMB clinical trial. Merck will also co-fund a portion of the Tukysa global development plan, which encompasses several ongoing and planned trials across HER2-positive cancers, including breast, colorectal, gastric and other cancers set forth in a global product development plan. Seattle Genetics will continue to lead ongoing Tukysa global development planning and operational execution. Merck will solely fund and conduct country-specific clinical trials necessary to support anticipated regulatory applications in its territory. Seattle Genetics will receive from Merck $125M as an upfront payment and is eligible to receive progress-dependent milestones of up to $65M. Seattle Genetics will also receive $85M in prepaid research and development payments to be applied to Merck's global development funding obligations. In addition, Seattle Genetics would receive tiered royalties on sales of Tukysa in Merck's territory.
|
MNK | Hot Stocks06:53 EDT Mallinckrodt receives CRL from FDA for terlipressin - Mallinckrodt announced that the FDA has issued a Complete Response Letter, or CRL, regarding the company's New Drug Application, or NDA, seeking approval for the investigational agent terlipressin to treat adults with hepatorenal syndrome type 1, or HRS-1. Mallinckrodt said in a release, "The CRL stated that, based on the available data, the agency cannot approve the terlipressin NDA in its current form and requires more information to support a positive risk-benefit profile for terlipressin for patients with HRS-1. HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis for which there is currently no FDA-approved treatment. HRS-1 is estimated to affect between 30,000 and 40,000 Americans annually, and often is a challenge to effectively diagnose in a timely manner due to its diagnosis of exclusion. If left untreated, HRS-1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months. U.S. discharge data in a recently published study indicated an in-hospital mortality rate of 34.2%, while an additional 14.4% of patients were discharged to hospice."
|
LLY INCY | Hot Stocks06:37 EDT Eli Lilly, Incyte: baricitinib/remdesivir combo reduce COVID-19 recovery time - Eli Lilly (LLY) and Incyte (INCY) said in a release, "Eli Lilly and Incyte announced initial data emerging from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health, or NIH. ACTT-2 included more than 1,000 patients and began on May 8 to assess the efficacy and safety of a 4-mg dose of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. Baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir. Study investigators noted an approximately one-day reduction in median recovery time for the overall patient population treated with baricitinib in combination with remdesivir versus those treated with remdesivir. This finding was statistically significant. Recovery was defined as the participant being well enough for hospital discharge, meaning the participant either no longer required supplemental oxygen or ongoing medical care in the hospital, or was no longer hospitalized at Day 29. The study also met a key secondary endpoint comparing patient outcomes at Day 15 using an ordinal 8-point scale ranging from fully recovered to death. An independent data and safety monitoring board overseeing the double-blind, randomized controlled trial met regularly throughout the trial to review safety data. Additional analyses are ongoing to understand other clinical outcome data, including mortality and safety data. NIAID is expected to publish full details of the study in a peer-reviewed journal. Based on the ACTT-2 data, Lilly plans to discuss the potential for emergency use authorization, or EUA, with the FDA and to explore similar measures with other regulatory agencies for baricitinib as a treatment of hospitalized patients with COVID-19. If authorized for use, Lilly will propose that baricitinib be available through commercial channels and will work with hospitals and governments to ensure patient access. Lilly will continue to create adequate supply for rheumatoid arthritis, or RA, patients and ensure baricitinib remains available in countries where it is approved. In the U.S., baricitinib is approved for RA patients at a 2-mg daily dose; an EUA would potentially authorize a 4-mg dose for COVID-19. Lilly will review the ACTT-2 data with NIAID and assess any impact on COV-BARRIER, the Phase 3 randomized, double-blind, placebo-controlled study it initiated in June to evaluate the efficacy and safety of baricitinib versus background therapy in hospitalized adults with COVID-19 in the U.S., Europe, Asia and Latin America."
|
FHN | Hot Stocks06:37 EDT First Horizon to launch ClearPath Fast Payments in partnership with Interchecks - First Horizon announced that it will be launching ClearPath Fast Payments in partnership with Interchecks. This partnership will provide a platform that delivers immediate payments capability to treasury management clients. "Following our merger with IBERIABANK, we are able to bring this industry-leading payment innovation to a broader market and better serve our clients," said Somesh Kasibhatla, head of treasury product management. "Whether receiving wages, commission payouts, insurance claim payments, or an incentive for renewing with your utility service, businesses and consumers want to be paid as quickly and conveniently as possible. Leveraging Interchecks' platform allows First Horizon to offer the latest digital payment methods while still accommodating payees who choose to receive a direct deposit or even a paper check."
|
SWTX JNJ | Hot Stocks06:34 EDT SpringsWorks Therapeutics enters collaboration, supply agreement with Janssen - SpringWorks Therapeutics (SWTX) announced that the company has entered into a clinical collaboration and supply agreement with Janssen (JNJ) to evaluate SpringWorks Therapeutics' investigational gamma secretase inhibitor, or GSI, nirogacestat, in combination with Janssen's bispecific antibody targeting B-cell maturation antigen, or BCMA and CD3, teclistamab, in patients with relapsed or refractory multiple myeloma. Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of myeloma cells. In preclinical models, nirogacestat has been shown to increase the cell surface density of BCMA and reduce levels of soluble BCMA, which may enhance the activity of BCMA-targeted therapies, including CD3 bispecific antibodies. Under the terms of the agreement, Janssen will sponsor and conduct the Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of the combination, and will assume all costs associated with the study, other than expenses related to the manufacturing of nirogacestat. SpringWorks Therapeutics will also form a joint oversight committee with Janssen. Pending discussions with regulators, the study is anticipated to commence by early 2021. In addition to its ongoing clinical collaborations with BCMA-directed therapies, SpringWorks is also currently conducting a global Phase 3, double-blind, randomized, placebo-controlled clinical trial to evaluate nirogacestat in adults with progressing desmoid tumors.
|
SGMS | Hot Stocks06:25 EDT Scientific Games investors to acquire 34.9% stake owned by MacAndrews & Forbes - Scientific Games announced that a number of long-term institutional investors, including Caledonia, have reached agreement to acquire a 34.9% stake in Scientific Games from MacAndrews & Forbes at a price of $28.00 per share. In connection with the transaction, Scientific Games is implementing a series of governance changes and enhancements, including refreshment of its board and termination of the stockholders agreement with MacAndrews & Forbes, to reflect its new investor base and continue to position the company for growth and value creation. The Scientific Games board will be reconstituted to include all existing directors, other than the MacAndrews & Forbes representatives, as well as three new directors. The board will comprise a majority of independent directors with a deep and diverse mix of gaming industry, financial, strategic and operational experience. Former Aristocrat CEO Jamie Odell, along with former Aristocrat CFO Toni Korsanos, will join the Scientific Games board as executive chair and executive vice chair, respectively. They will be joined on the board by an additional independent non-executive director. Ronald Perelman, current executive chairman of the Scientific Games board and MacAndrews & Forbes chairman and CEO, as well as Barry Schwartz and Frances Townsend, the two other MacAndrews & Forbes representatives, will resign from the board. During Odell's tenure as CEO of Aristocrat from 2009 to 2017, Aristocrat's market capitalization increased from $1.3B to approximately $7.5B. Odell and Korsanos currently serve as senior advisors to the Scientific Games board and work with Cottle to develop and support the company's current growth strategies. Upon completion of the transaction, the stockholders agreement with MacAndrews & Forbes will be terminated and all rights held by MacAndrews & Forbes, other than registration rights, will no longer be in effect. This includes any rights to appoint directors to the Scientific Games board. Following the transaction, the company's corporate governance provisions will be in line with typical publicly traded companies. No investor is expected to beneficially own more than 9.9% of the company's shares as a result of the transaction.
|
AXSM | Hot Stocks06:20 EDT Axsome Therapeutics presents new data from GEMINI Phase 3 trial - Axsome Therapeutics said in a release, "Axsome Therapeutics announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, rapidly and significantly improved patient-reported outcomes of depression in patients with major depressive disorder, or MDD, in the GEMINI Phase 3 trial. These findings were presented at the 33rd Congress of the European College of Neuropsychopharmacology, or ECNP, being held virtually September 12-15. The GEMINI study was a randomized, double-blind, placebo-controlled, multi-center, U.S. trial, in which 327 adult patients with confirmed moderate to severe MDD were randomized to treatment with either AXS-05 (dextromethorphan/bupropion modulated delivery tablet) or placebo once daily for the first 3 days and twice daily thereafter for a total of 6 weeks. Two patient-reported outcomes, or PROs, for depression were assessed in this trial: the Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR-16), and the Patient Global Impression of Improvement (PGI-I) for depression. The QIDS-SR-16 is a well-established PRO that was the primary outcome measure in the landmark NIH-funded STAR*D trial of antidepressant treatments3. A PRO is a report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else. PROs therefore provide a measurement of patients' perception of their own depression status as a result of an intervention. The PROs complement the clinician-rated measures, such as the Montgomery-Asberg Depression Rating Scale, or MADRS, that were also assessed in the GEMINI trial. AXS-05 demonstrated a highly statistically significant reduction in patient-reported depressive symptoms compared to placebo at Week 6, with mean reductions from baseline in the QIDS-SR-16 total score of 7.8 points for AXS-05 and 5.4 points for placebo, representing 48% and 34% reductions from baseline, respectively. AXS-05 rapidly and durably improved patient-reported depressive symptoms as compared to placebo with statistical significance on the QIDS-SR-16 total score demonstrated at Week 1, the earliest time point assessed, at Week 2, and at all time points thereafter. Clinical response on the QIDS-SR-16 (defined as greater than or equal to50% improvement) was statistically significantly greater for AXS-05 compared to placebo at Week 1, at Week 2, and at every time point thereafter, being achieved by 53.4% of AXS-05 patients compared to 32.9% of placebo patients at Week 6. On the patient-reported global measure of depression, the PGI-I, AXS-05 demonstrated highly statistically significant improvements as compared to placebo, with 47.2% of patients treated with AXS-05 reporting that their depression was "very much" or "much" improved compared to 31.3% of placebo patients at Week 6. Improvement on the PGI-I with AXS-05 as compared to placebo was rapid and durable with statistical significance demonstrated at Week 1 and at all time points thereafter. The results on these patient-reported measures are consistent with those observed with the corresponding clinician-rated scales, the MADRS and the Clinical Global Impression of Improvement (CGI-I). As previously reported, AXS-05 met the primary endpoint in the GEMINI trial by demonstrating a highly statistically significant reduction in the MADRS total score compared to placebo at Week 6, with mean reductions from baseline of 16.6 points for AXS-05 and 11.9 points for placebo. AXS-05 also demonstrated statistically significant improvement at Week 6 compared to placebo on the CGI-I. Rapid improvement in depressive symptoms was also demonstrated on these clinician-rated scales, with statistically significant improvements starting at Week 1 and every timepoint thereafter."
|
SRNE | Hot Stocks06:10 EDT Sorrento Therapeutics enters license pact with Mayo Clinic for ADNIC platform - Sorrento Therapeutics announced it has entered into an exclusive license agreement with Mayo Clinic for a potential breakthrough technology platform that is capable of generating a great diversity of stable antibody-drug-nanoparticle albumin-bound, or nab, immune complexes, or ADNICs, targeting many types of human diseases including various solid and liquid tumors. The ADNIC is the next generation in antibody drug conjugate, or ADC, technology that potentially addresses limitations of current ADC technology, such as complex manufacturing processes, which can affect drug half-life, stability and tumor accessibility, and result in high cost of goods, or COGs. The ADNIC platform is currently generating clinical data at Mayo Clinic through clinical trials with multiple investigational products in a variety of cancers including ovarian, endometrial, and multiple lymphoma sub-types. These trials will continue and are expected to be expanded. The ADNIC technology, developed at Mayo Clinic, offers many potential advantages: optimizes the likelihood that a chemotherapeutic payload will be preferentially delivered to the specific, targeted cancer cell type; potentially more efficient and effective than traditional ADCs because ADNICs allow for the entire ADNIC complex to be absorbed into the targeted cancer cell rather than just the chemotherapeutic payload and uses non-covalent binding to external albumin sites to potentially facilitate delivery of both a monoclonal antibody and chemotherapeutic payload directly to the tumor and its microenvironment. The ADNIC technology potentially eliminates the need to use covalent linker technology by incorporating therapeutically or immunologically active antibodies in a reversible manner with a nanoparticle composed of albumin and a payload of one or more drugs. The technology platform is protected by a intellectual property portfolio comprised of 17 patent families, 32 patents granted to date with life through at least 2035 and another 135 patents pending.
|
VIACA VIAC | Hot Stocks06:07 EDT ViacomCBS to sell CNET Media to Red Ventures for $500M - Red Ventures said in a release, "Red Ventures, a portfolio of digital brands, today announced that it has entered into a definitive agreement to acquire CNET Media Group from ViacomCBS for $500 million. CNET Media Group is a pioneer in digital media. CNET, a leading global technology news brand, has grown over 25 years to cover all aspects of technology in our lives, including automotive coverage at Roadshow and Spanish-language technology coverage at CNET en Espanol. CNET paved the way for CNET Media Group, an expansive portfolio of digital media brands that advise consumers across leading consumer tech, business tech, gaming, and entertainment media brands including ZDNet, a leader in B2B focused content and Gamespot, a renowned games information brand in the US, according to ComScore. The portfolio also includes revered entertainment and lifestyle brands like TVGuide, Metacritic, and Chowhound. The transaction, which is expected to close in Q4 2020, is subject to regulatory approvals and customary closing conditions."
|
VIACA VIAC | Hot Stocks06:05 EDT ViacomCBS to sell CNET Media to Red Ventures for $500M
|
GCP | Hot Stocks06:04 EDT GCP Applied Technologies CEO Randy Dearth to depart, Simon Bates to succeed - GCP Applied Technologies announced that its board of directors has appointed Simon Bates as its president and CEO effective October 1. Bates will succeed Randy Dearth, who has served as the company's President and CEO since August 2019. Craig Merrill, GCP's CFO will assume the combined role of Interim CEO and Cfo until Bates joins the company on October 1. Bates, joins GCP Applied Technologies following a 24-year career in the specialty construction chemicals and building products industries. Most recently, he served as president, infrastructure products group, a division of CRH, with more than 85 locations globally. During his tenure, the business delivered growth in both revenues and profitability.
|
RADA | Hot Stocks05:57 EDT RADA Electronic announces $10M in new orders since mid-July - RADA Electronic said in a release, "RADA Electronic announced the receipt of $10 million in accumulated new orders since mid-July 2020. To date, the aggregate amount of new orders since the beginning of 2020 has reached $59 million, compared to $35 million received for the same period in 2019, demonstrating an increase of over 68% year-over-year. Out of the $10 million new orders, 70% were for RADA's growth-engine, software-defined tactical radars, for counter UAV and counter fires (C-RAM). Most of the new radar orders were follow-ons from existing customers. Deliveries of these orders are planned to be concluded within the next six months. The rest of the orders were for digital video recorders and debriefing stations for fighter aircraft, along with maintenance orders for RADA's avionics installed base. RADA reiterates its recently increased guidance for 2020, provided on August 11, with revenues expected to grow to over $70 million and representing an increase of over 58% year-over-year."
|
MOGU | Hot Stocks05:57 EDT Mogu announces up to $10M share repurchase program - Mogu announced that its board of directors has authorized a new share repurchase program, where the company is authorized to repurchase up to $10M of its shares, effective until September 12, 2021. The company expects to fund the repurchases under this program with its existing cash balance.
|
VRTX | Hot Stocks05:53 EDT Vertex Pharmaceuticals announces EMA validation of MAA for Kaftrio - Vertex Pharmaceuticals announced the European Medicines Agency, or EMA, has validated a Type II Variation Marketing Authorization Application, or MAA, for the expanded indication of Kaftrio in combination with ivacaftor to treat CF in patients ages 12 years and older with at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator, or CFTR, gene. If approved, eligible patients who have one copy of the F508del mutation and another CFTR mutation, such as a gating or residual function mutation, will also be eligible for treatment. The MAA is supported by results from the global Phase 3 study with Kaftrio announced in July. The application will now be reviewed by the Committee for Medicinal Products for Human Use, which will issue an opinion to the European Commission regarding the potential approval for these patients. Kaftrio in combination with ivacaftor is currently approved in Europe to treat people with CF ages 12 years and older with one F508del mutation and one minimal function mutation, or two F508del mutations in the CFTR gene.
|
FIT | Hot Stocks05:45 EDT Fitbit receives regulatory clearance in U.S., Europe for ECG app for AFib - Fitbit has received 510(k) clearance from the FDA, as well as Conformite Europeenne, or CE, marking in the European Union, for its electrocardiogram, or ECG, app to assess heart rhythm for atrial fibrillation, or AFib, a condition that affects more than 33.5M people globally. The Fitbit ECG App, unveiled in Fitbit's recent fall product launch, will be available in October to users on Fitbit Sense in the following countries: the United States, United Kingdom, Germany, Austria, Luxembourg, the Netherlands, Sweden, Switzerland, Czech Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France, Hong Kong and India.
|
AMZN | Hot Stocks05:42 EDT Amazon to hire additional 100,000 full- and part-time employees in U.S., Canada - Amazon announced that it is hiring an additional 100,000 regular employment opportunities throughout the U.S. and Canada on top of the 33,000 corporate and technology jobs announced last week. The roles offer a starting wage of at least $15 per hour, and in select cities Amazon is offering sign-on bonuses up to $1,000 to new hires. On top of Amazon's minimum $15 wage, the company offers full-time employees benefits, which include health, vision and dental insurance from day one, 401(k) with 50% company match, up to 20 weeks paid parental leave and Amazon's innovative career choice program, which pre-pays 95% of tuition for courses in high-demand fields.
|
CEL | Hot Stocks05:37 EDT Cellcom Israel appoints Shai Amsalem as CFO, announces two new board members - Cellcom Israel announced the appointment of Shai Amsalem as the company's CFO effective immediately and Eran Shenar and Diana Elsztein-Dan as members of the company's board, effective September 14. Shenar was nominated to the board by the company's employees, as per the February collective employment agreement. Amsalem has served as CFO of Golan Telecom since 2017. Shenar is the founder and co-owner of Best-Medical Center as of 2019 and of the Multidisciplinary Center of Gastroenterology since 2015 and has served as a business and financial consultant since 2010. Diana Ingrid Elsztain-Dan has served as a director of Discount Investment Corporation since December 2019 and as a director of IDB Development Corporation since 2016.
|
WTKWY | Hot Stocks05:34 EDT Wolters Kluwer to acquire XCM Solutions, valued at EUR 136M - Wolters Kluwer announced that it has entered into an agreement to acquire XCM Solutions, a cloud-based workflow solutions provider for professional tax and accounting firms. The acquisition offers integration opportunities with CCH Axcess, the company's cloud-based software suite for professional firms in North America. Wolters Kluwer Tax & Accounting North America has had a longstanding strategic partnership with XCM Solutions since 2006, enabling firms to integrate XCM workflow tools with CCH ProSystem fx on-premise software and, since 2012, with CCH Axcess, our cloud-based, modular software platform. Wolters Kluwer and XCM share a common approach to providing cloud-based solutions. Founded in 2002, XCM serves professional tax and accounting firms of all sizes across the U.S. and Canada. XCM solutions help firms control their workflow processes and allocate their resources in order to achieve greater efficiency, productivity and profitability. The company's main product is XCMworkflow, a cloud-based system that aligns with a firm's existing systems and helps them manage all types of work across multiple clients, projects, and offices, streamlining workflows between systems and facilitating a more open and collaborative way of working. XCM recorded revenues of EUR 19M in calendar year 2019. Approximately 75% of XCM 2019 revenues were from cloud-based software, of which the majority was subscription-driven. XCM also provides outsourcing and technology-enabled services to support clients during the tax season. The transaction values XCM Solutions at EUR 136M. With revenue and cost synergies anticipated over the medium to long term, the company expects the acquisition to achieve a return on invested capital above after-tax weighted average cost of capital within three to five years. The near-term impact on Wolters Kluwer adjusted net profit is immaterial. Headquartered in Quincy, Massachusetts, XCM has approximately 440 employees located in the U.S. and India. The transaction is expected to close in the next few weeks once customary closing conditions have been met.
|
NSRGY AIMT | Hot Stocks05:33 EDT Nestle commences tender offer for Aimmune - Societe des Produits Nestle (NSRGY) announced that its wholly-owned subsidiary, SPN Merger Sub, is commencing today a cash tender offer to purchase all of the outstanding shares of common stock of Aimmune Therapeutics (AIMT) for a price of $34.50 per share, net to the seller in cash, without interest and subject to any withholding taxes. The company said in a release, "The Offer is being made upon the terms and subject to the conditions set forth in the Offer to Purchase, and related Letter of Transmittal and other related materials that will be filed by Nestle and Purchaser with the United States SEC on September 14 and pursuant to the terms of the previously announced Agreement and Plan of Merger, dated as of August 29, by and among Nestle, Purchaser and Aimmune. In addition, Aimmune will file today a Solicitation/Recommendation Statement on Schedule 14D-9 and a Schedule 13E-3 transaction statement relating to the Offer with the SEC. The independent members of the board of directors of Aimmune have declared the Offer to be fair to and in the best interests of Aimmune and Aimmune's stockholders and recommend that such stockholders accept the Offer and tender their shares of Aimmune common stock pursuant to the Offer. The Offer will expire at 12:00 midnight, Eastern time, on October 9, unless extended or earlier terminated. Any extension of the Offer will be announced in a press release or other public announcement before 9:00 a.m., Eastern time, on the first business day after the Expiration Date."
|
DVAX | Hot Stocks05:31 EDT Dynavax, Valneva announce commercial supply agreement for COVID-19 vaccine - Valneva and Dynavax Technologies announced a commercial partnership for the supply of Dynavax's CpG 1018 adjuvant for use in Valneva's SARS-CoV-2 vaccine candidate, VLA2001. The companies said in a release, "Valneva separately announced today an agreement with the UK government to provide up to 190 million doses of VLA20011 over a five year period. Dynavax will supply CpG 1018 to produce up to 100 million doses of vaccine in 2021. Valneva has the option to purchase up to an additional 90 million doses through 2025. Valneva expects VLA2001 to enter clinical studies by the end of 2020 and to potentially reach regulatory approval in the second half of 2021. This commercial supply partnership follows Valneva and Dynavax's initial collaboration to advance COVID-19 vaccine development, announced in April 2020."
|
REGN SNY | Hot Stocks05:28 EDT Regeneron, Sanofi granted Breakthrough Therapy designation for Dupixent by FDA - Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced the FDA has granted Breakthrough Therapy designation to Dupixent (dupilumab) for the treatment of patients 12 years and older with eosinophilic esophagitis, or EoE. The companies said in a release, "The designation for this investigational use is based on positive results from Part A of a Phase 3 trial in patients with EoE. There are currently no FDA-approved medicines for EoE, a chronic and progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly. Over time, excessive type 2 inflammation causes scarring and narrowing of the esophagus, making it difficult to swallow. If left untreated, EoE can affect a patient's ability to eat and cause food to become stuck after being swallowed (food impaction), which can lead to a medical emergency. In the U.S. alone, there are approximately 160,000 patients with EoE who are currently being treated with various unapproved therapies or diet modification. Of these patients, approximately 50,000 have failed multiple treatments."
|
DOW | Hot Stocks05:21 EDT Dow Inc. announces sale of U.S. Gulf Coast marine, terminal operations, assets - Dow Inc. said in a release, "Dow announced that it has entered into a definitive agreement to divest certain U.S. Gulf Coast marine and terminal operations and assets to Vopak Industrial Infrastructure Americas, a joint venture of Royal Vopak and BlackRock's Global Energy & Power Infrastructure Fund, for $620 million. The transaction includes marine and storage terminal operations and assets at Dow's sites in Plaquemine and St. Charles, Louisiana, and Freeport, Texas. Royal Vopak is a leading global independent tank storage company with over 400 years of expertise in independent storage and infrastructure services and a strategy designed to support growth opportunities and care for the assets, employees, as well as the broader sites and communities where they reside. In connection with today's announcement, Dow and Vopak Industrial Infrastructure Americas have entered into long-term service agreements, ensuring reliable and cost-advantaged services for existing Dow businesses at the in-scope sites. The transaction is expected to close in the fourth quarter of 2020, subject to customary regulatory approvals and other closing conditions in the United States and the European Union. Normal operations will continue throughout the divestment process. Dow continues to evaluate its ownership of non-revenue-generating assets across its global portfolio as announced on July 6, 2020, when the Company announced a signed agreement to sell its rail infrastructure and assets at six North American sites. Also, as announced separately on July 23, 2020, the Company is taking other actions to exit non-competitive assets."
|
JILL | Hot Stocks05:15 EDT J.Jill obtains consents to implement out of court consensual restructuring deal - J.Jill said in a release, "J.Jill announced it has obtained the necessary consents from its term loan lenders to implement the previously announced financial restructuring transaction on an out of court basis. The Company received consents from lenders holding 97.8% of the Company's term loans on the terms of the Transaction that are intended to result in a waiver of any past non-compliance with the Company's credit facilities and provide the company with additional liquidity. The Company expects the Transaction to close on or about September 30, subject to obtaining consent to the Transaction and a waiver of all existing non-compliance with the terms of the Company's asset-based credit facility from the requisite lenders under the Company's ABL Facility, and finalizing the other terms and documentation related to the Transaction. Under the terms of the Transaction, the maturity of certain participating term loan debt will be extended to May 2024, all existing non-compliance with the terms of the Company's credit facilities will be waived, the Company will be granted a financial covenant holiday under certain participating term loan debt until Q4 2021, and will receive an investment of no less than $15 million in the form of a junior term loan facility. The Transaction provides J.Jill with the financial flexibility to continue to meet its obligations to its vendors in full and continue to execute on its business plan. As previously announced, all vendor claims will be unimpaired and paid in the ordinary course under the Transaction."
|