Stockwinners Market Radar for October 08, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

FMX

Hot Stocks

22:53 EDT Femsa reaches deal with SMU to acquire OK Market stores for CLP43.5B - Fomento Economico Mexicano announced that its subsidiary, FEMSA Comercio has reached an agreement with SMU, S.A, a Chilean retailer, to acquire its OK Market store chain for a total amount of approximately CLP $43.5B. The transaction is subject to final confirmatory due diligence, the signing of definitive agreements and customary regulatory and anti-trust approvals and is expected to close during 2021.
CZR

Hot Stocks

20:01 EDT Caesars resumes operation at Planet Hollywood Resort & Casino - The company states: "In accordance with directives from Nevada Governor Steve Sisolak and the Nevada Gaming Control Board, Caesars Entertainment has resumed gaming operations daily and hospitality operations for weekend stays at Planet Hollywood Resort & Casino today, Oct. 8. This follows the successful reopening of Caesars Palace Las Vegas, Flamingo Las Vegas, Harrah's Las Vegas, Paris Las Vegas, Bally's Las Vegas and The LINQ Hotel + Experience. As previously announced, the Company has also reopened The LINQ Promenade, High Roller Observation Wheel, FLY LINQ and Eiffel Tower Viewing Deck."
VLDR

Hot Stocks

19:00 EDT Velodyne Lidar, RoboSense enter global cross-licensing relationship - Velodyne Lidar announced that the two companies have entered a long-term global cross-licensing relationship encompassing a broad range of 360 degrees surround-view lidar sensors. This mutually beneficial relationship covers both existing and future patents of both companies. Velodyne and RoboSense have also agreed to dismiss all the current legal proceedings in the U.S and China that exist between the two companies. Velodyne and RoboSense are looking forward to a lidar market that will offer highly diverse products for real time 3D sensing applications to benefit the community of autonomous vehicles and other applications.
JE

Hot Stocks

18:49 EDT Just Energy up over 11% at $6.25 per share after PIMCO disclosed 29% stake - Shares of Just Energy are up 11.8% at $6.25 per share after PIMCO disclosed a 28.9% activist stake in a 13D filing afterhours. PIMCO stated: "In connection with the closing of the Recapitalization, the PIMCO Entities entered into an investor rights agreement with the Issuer, Sagard Credit Partners. Pursuant to the Investor Rights Agreement, the PIMCO Entities and Sagard Entities will be entitled to designate one individual for election or appointment to the Issuer's board of directors or, whenever the PIMCO Entities and Sagard Entities collectively hold 20% or more of the Common Shares, the PIMCO Entities and Sagard Entities will be entitled to designate two individuals for election or appointment to the Issuer's board of directors. The Investor Rights Agreement also provides the PIMCO Entities and the Sagard Entities with customary demand and "piggyback" registration rights. The PIMCO Entities may exercise any of their director designation rights and registration rights pursuant to the Investor Rights Agreement in their sole discretion; however, the PIMCO Entities have agreed to consult with the Sagard Entities prior to, in each case, designating a director to the Issuer's board or exercising any registration rights under the Investor Rights Agreement."
DIS

Hot Stocks

18:44 EDT Disney's 'Soul' to stream exclusively on Disney+ on December 25 - Disney said that Pixar film "Soul" will be streaming exclusively on Disney+ on December 25, 2020. Reference Link
DPZ

Hot Stocks

18:26 EDT Domino's Pizza CEO: It's simply more expensive to operate during the pandemic - In an interview on CNBC's Mad Money, Ritch Allison said the company saw some cost pressures over the short term due to the COVID-19 pandemic, but he expects them to be temporary. Domino's had a "great quarter" in top-line growth with strong sales of specialty pizzas, Allison noted. "We've seen a nice tailwind for pizza deliveries in the markets that remained open," he said.
ET

Hot Stocks

18:03 EDT Energy Transfer LP names Mackie McCrea and Tom Long as Co-CEOs - Energy Transfer LP announced that long-time Energy Transfer executives Mackie McCrea and Tom Long have been named as Co-CEOs, effective January 1, 2021. Energy Transfer co-founder Kelcy Warren will remain as Executive Chairman of Energy Transfer and Chairman of the Board of Directors. As Co-CEOs, McCrea and Long will work together in the manner of an "Office of the CEO" and will jointly direct the business of the Partnership. Warren will continue to be actively involved in the strategic direction of the Partnership. McCrea first joined the Partnership in 1997 as Senior Vice President Business Development. Since that time he has served in a number of leadership roles including Group COO and Chief Commercial Officer of Energy Transfer Operating, L.P., and most recently as President and Chief Commercial Officer of Energy Transfer. McCrea also serves on the Energy Transfer Board of Directors. Long has served as the Partnership's CFO since February of 2016. Prior to assuming this role, he served for five years as Executive Vice President and CFO of Regency Energy Partners LP, which was acquired by Energy Transfer in 2010.
FB

Hot Stocks

17:53 EDT Facebook removes fake account networks based in U.S., Myanmar, Nigeria - Facebook shared an update on the enforcement actions it has taken since its last monthly report on coordinated inauthentic behavior. This includes both its September CIB report and a set of enforcement actions the company has taken in the last few days. In total, Facebook is publishing its findings about 10 networks - six operations we removed in September, most of which it has already announced, and four new operations that it removed since October 1. Facebook said it has removed 200 Facebook accounts, 55 Pages and 76 Instagram accounts for violating its policy against coordinated inauthentic behavior. This activity originated in the U.S. and focused primarily on domestic U.S. audiences and also on Kenya and Botswana. The company also removed 17 Pages, 50 Facebook accounts and 6 Instagram accounts for violating its policy against coordinated inauthentic behavior. This domestic-focused activity originated in Myanmar. Facebook also removed 589 Facebook accounts, 7,906 Pages and 447 accounts on Instagram that were involved in coordinated inauthentic behavior. This network originated in Azerbaijan and focused primarily on domestic audiences. In addition, the company removed 79 Facebook accounts, 47 Pages, 93 Groups and 48 Instagram accounts engaged in coordinated inauthentic behavior. This activity originated primarily in Nigeria and focused on domestic audiences. Reference Link
NWN

Hot Stocks

17:35 EDT Northwest Natural Gas raises quarterly dividend to 48c per share - The board of directors of Northwest Natural Holding Company has increased the quarterly dividend to 48c per share on the company's common stock. The dividend will be paid on November 13, 2020 to shareholders of record on Oct. 30, 2020. The company's indicated annual dividend rate is $1.92 per share.
ADI MXIM

Hot Stocks

17:19 EDT Analog Devices, Maxim Integrated shareholders approve merger - Analog Devices (ADI) and Maxim Integrated Products (MXIM) announced that, at their respective special meetings of shareholders, ADI and Maxim shareholders voted to approve their respective proposals relating to the pending combination of ADI and Maxim. The companies continue to expect that the transaction will be completed in the summer of 2021.
GILD

Hot Stocks

17:18 EDT Gilead anticipates meeting real-time demand for remdesivir - The company states: "Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of Veklury for the treatment of COVID-19, in different patient populations, formulations, and in combination with other therapies. Based on available data from these studies, Veklury has been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide. As announced on October 1, 2020, Gilead is now meeting real-time demand for Veklury in the United States and anticipates meeting global demand for Veklury in October, even in the event of potential future surges of COVID-19."
GILD

Hot Stocks

17:13 EDT NEJM publishes ph.3 trial data for Gilead's remdesivir showing faster recovery - The company states: "The New England Journal of Medicine published the final results from the NIAID's double-blind, placebo-controlled, Phase 3 ACTT-1 trial of Gilead's investigational antiviral Veklury, or remdesivir, for the treatment of adults hospitalized with mild-moderate or severe COVID-19. The final ACTT-1 study results build on the preliminary results published in NEJM in May 2020, showing that treatment with Veklury resulted in consistent, clinically meaningful improvements across multiple outcome assessments compared with placebo in COVID-19 patients. The final results demonstrate that treatment with Veklury resulted in a faster time to recovery than previously reported. In the preliminary Day 15 results, Veklury plus standard of care shortened the time to recovery by four days, compared with placebo plus standard of care - 11 vs. 15 days. The primary endpoint of the study was time to clinical recovery through Day 29. The study met its primary endpoint, demonstrating Veklury plus standard of care was superior in shortening the time to recovery through Day 29 compared with placebo plus standard of care. In the final Day 29 results, patients receiving Veklury achieved clinical recovery five days faster than those receiving placebo, with a median time to recovery of 10 days with Veklury and 15 days with placebo and an increased recovery rate by 29% compared with placebo . This result was most pronounced in patients who required oxygen support at baseline; in this group, patients receiving Veklury achieved clinical recovery seven days faster than those receiving placebo, with a median time to recovery of 11 days with Veklury and 18 days with placebo. The key secondary study endpoint of clinical status at Day 15 was also met. Patients receiving Veklury were 50% more likely to have improved by Day 15 compared with those receiving placebo, and the effect was maintained through Day 29. The benefit of Veklury was greater when given within 10 days of symptom onset, though benefit was observed across most ranges of symptom duration. In the overall study population, there was a trend toward reduced mortality, a secondary study endpoint, at Day 15 and Day 29 in Veklury-treated patients compared with placebo. Given the range of disease severity in the overall study population, a post-hoc analysis with no adjustment for multiple testing was conducted to determine whether there were differences in mortality based on patients' baseline clinical status and to better understand where Veklury may have the most benefit. In this analysis, patients requiring low-flow oxygen at baseline who received Veklury achieved a statistically significant 72% reduction in mortality at Day 15 and a statistically significant 70% reduction in mortality at Day 29. The difference in mortality in other subgroups based on baseline clinical status was not statistically significant."
HCA

Hot Stocks

17:05 EDT HCA Healthcare to repay about $6B in government assistance funds through CARES - The company states: "The CARES Act, enacted on March 27, 2020, was intended to provide emergency financial assistance to healthcare providers for the adverse impact the COVID-19 pandemic could have on their operations. During the early days of the pandemic, the company took a conservative approach which included a number of actions to meet the operational and financial challenges this global health crisis was expected to present. Many aspects of our approach were outlined in our first quarter release. As a result of these actions, and other factors, HCA Healthcare is able to return, or repay early, all of its share of Provider Relief Fund distributions of approximately $1.6B and approximately $4.4B in Medicare accelerated payments. The company will work with the appropriate government agencies to arrange the payment of these funds. The company expects to fund the entire amount of such payments from available cash and future cash flows from operations."
HCA

Hot Stocks

17:03 EDT HCA Healthcare sees Q3 facility admissions down 4% - The company states: "Same facility admissions for the third quarter of 2020 are expected to decline 4%, and same facility equivalent admissions are expected to decline 9%, when compared to the third quarter of 2019. Same facility emergency room visits for the third quarter of 2020 are expected to decline 20% from the prior year's third quarter."
KBH

Hot Stocks

17:03 EDT KB Home raises quarterly dividend 67% to 15c per share - KB Home announced that its Board of Directors approved an increase in the company's quarterly cash dividend on its common stock to 15c per share from 9c per share. This 67% increase raises the company's annual dividend rate to 60c per share from the previous rate of 36c per share, representing a yield of approximately 1.5%, based on the closing price of the company's common stock on October 8, 2020. In addition, the Board of Directors declared the next quarterly cash dividend, at the 15c per share rate, will be payable on November 26, 2020 to stockholders of record on November 12, 2020.
AAV

Hot Stocks

17:01 EDT Advantage Oil & Gas raises FY20 capital guidance to $147M-$162 from $130M-$145M - Advantage Oil & Gas Ltd. announced a modest increase in 2020 capital guidance, as a result of continued strengthening of the corporation's outlook. Spending for 2020 is now projected to be between $147M and $162M, an increase of approximately $17 million, primarily to accelerate a four-well pad into Q4 2020 and augment natural gas production through the winter season. Advantage's 2021 production is expected to grow between 5% and 10%, with exceptional growth anticipated in adjusted funds flow based on current natural gas futures pricing. Directionally, Advantage expects that 2021 net capital expenditures will be approximately 75% of AFF, and that net debt to AFF ratio will approach 1x by year-end 2021. The Corporation plans to provide formal 2021 guidance during the fourth quarter of 2020.
HL

Hot Stocks

16:58 EDT Hecla Mining backs FY20 silver and gold production guidance - Backs FY20 total silver production of 12.4-13.0 million ounces and total gold production of 199-210 million ounces.
HL

Hot Stocks

16:57 EDT Hecla Mining reports Q3 production - Hecla Mining reported Q3 production results and its cash position at quarter end. Q3 silver production was up9% year-over-year to 3.5 million ounces, gold production was down 47% year-over-year at 41,174 ounces, and equivalent production for silver of 9.0 million ounces or gold of 114,998 ounces. Reports Q3 lead production up 60% to 9,750 tons; zinc production up 17% year-over-year to 17,997 tons. The company had cash and cash equivalents of approximately $97M at September 302020. CEO Phillips Baker stated, "Hecla's strong operating performance was from increasing silver production at Greens Creek and Lucky Friday and managing COVID-19 at all the mines. This operating performance combined with higher silver prices allowed us to close the quarter with $97M of cash and cash equivalents while fully repaying our revolving credit facility. Given our free cash flow generation, we expect to spend about $5M more in exploration, and based on our realized silver price for the quarter being above $25, we expect the silver-linked dividend to be triggered."
CRUS

Hot Stocks

16:47 EDT Cirrus Logic director sells 19.3K shares of common stock - In a regulatory filing, Cirrus Logic disclosed that its VP of R&D Jeffrey Baumgartner sold 19.3K shares of common stock on October 6th in a total transaction size of $1.35M. The holding represents about 67% of his total owned.
VEEV

Hot Stocks

16:46 EDT Veeva officer Zuppas sells 4,099 company shares - Veeva officer Eleni Nitsa Zuppas sold 4,099 shares on October 6 at $287.73 per share for a transaction total of $1,179,386.
TMUS

Hot Stocks

16:44 EDT T-Mobile General Counsel sells 15K shares of common stock - In a regulatory filing, T-Mobile disclosed that its General Counsel David Miller sold 15K shares of common stock on October 6th in a total transaction size of $1.7M. The holding represents about 9% of his total owned.
FIS

Hot Stocks

16:41 EDT FIS names Ido Gileadi as COO - Effective October 7, the Board of Directors of Fidelity National Information Services appointed Ido Gileadi to be the company's COO. Gileadi has served as the Chief Information Officer of the company since 2014, during which time he set and managed the company's technology strategy and its internal and external facing systems. Prior to his role as CIO for the company, Gileadi was a senior partner at The Capital Markets Company, which was acquired by, and became a subsidiary of, the company in 2010, and he continued in that role through 2013.
VERI LIVX

Hot Stocks

16:33 EDT Veritone appoints Michael Zemetra as CFO - Veritone (VERI) has appointed Michael Zemetra as Executive VP, CFO and Treasurer, effective today, as part of a planned transition. Zemetra succeeds Peter Collins, who will continue to serve in an advisory capacity during a transition period. Collins and Zemetra will work with the company's management team and other stakeholders to ensure a smooth transition. Zemetra most recently served as Executive VP and CFO of LiveXLive Media (LIVX). Prior to that, he held senior financial leadership positions with a number of publicly-traded SaaS, technology and digital media companies. Zemetra began his career in the technology and entertainment groups of PricewaterhouseCoopers.
NXPI

Hot Stocks

16:29 EDT NXP Semiconductors jumps 6% after providing improved Q3 revenue view - Shares of shares NXP Semiconductors jumped over 6% or to more than $8.00 per share to $143 in after-hours trading on Thursday, after the chip-maker said it sees Q3 revenue of $2.27B, compared with an earlier mid-point forecast of $2B. Analysts were expecting Q3 revenue of $2B.
MODN

Hot Stocks

16:21 EDT Model N CFO David Barter departs - Model N CEO Jason Blessing stated, "After the completion of our fiscal year, our CFO, David Barter, decided to accept a new opportunity. He will be joining C3.ai, and while he will be sorely missed at Model N, we wish him much success. (,...) David will continue to support the Model N team in an advisory capacity through our earnings release on November 10th to ensure a smooth transition. We have begun a search for David's replacement and appreciate David's continued support and engagement during the transition period."
CXP

Hot Stocks

16:18 EDT Columbia Property, Allianz Real Estate complete JV for San Francisco property - Columbia Property and Allianz Real Estate announced that they have completed the formation of a joint venture, or JV, to recapitalize 221 Main Street in San Francisco. Allianz contributed cash of $180M for a 45% ownership interest in the joint venture, which values 221 Main Street at $400M. Consistent with most of the other ventures between Columbia and Allianz, Columbia will retain a 55% ownership stake and function as general partner for the venture. Columbia will also continue to oversee the day-to-day operations of the asset. 221 Main Street is a 381,000-square-foot, LEED Platinum and Energy Star-certified office building in San Francisco's South Financial District. Acquired by Columbia in 2014, the property features Bay views and outdoor space. The building is fully leased. With this transaction, 221 Main Street has become the fifth office asset owned by joint ventures between Columbia and Allianz Real Estate, which now have a collective gross asset value of approximately $2.3B.
GPS

Hot Stocks

16:16 EDT Gap confirms Nancy Green as President and CEO of Old Navy - Gap announced the appointment of Nancy Green as the President and CEO of Old Navy, the company's largest brand. Green will report to Sonia Syngal, CEO of Gap Inc. and will serve on the company's senior leadership team. Green has served as interim head of Old Navy since March and was previously President and Chief Creative Officer of the brand.
SELB

Hot Stocks

16:14 EDT Selecta, IGAN in research and option pact to study combo treatment of IgAN - Selecta Biosciences and IGAN Biosciences announced that they have entered into a Research License and Option agreement to study Selecta's ImmTOR immune tolerance platform in combination with IGAN's immunoglobulin A, IgA, protease for the treatment of IgA Nephropathy, IgAN. In advance of exercising its option to enter into an exclusive license agreement, Selecta will conduct preclinical research to evaluate the utility of the combination of ImmTOR and IGAN's IgA protease. Previous studies in animal models conducted at independent laboratories established the ability of IGAN's IgA protease to remove injurious IgA from kidneys and improve markers of renal dysfunction. These results suggest that it is an excellent candidate to decrease the rate of disease progression and possibly even reverse the disease. The barrier to IgA protease commercialization is the bacterial origin of the protease, which makes it immunogenic. Selecta's proprietary immune tolerance platform, ImmTOR, has shown in clinical studies the ability to mitigate the formation of anti-drug antibodies, ADAs,to immunogenic enzymes. This has been demonstrated with its phase 3 lead product candidate, SEL-212, which is a combination of ImmTOR and pegadricase, an immunogenic proprietary pegylated uricase for the treatment of chronic refractory gout. Selecta and IGAN intend to combine IGAN's IgA protease with Selecta's ImmTOR platform to develop a novel combination product to treat IgA nephropathy, a disease with significant unmet medical need. "We are excited to build on our learnings from SEL-212 in combining an immunogenic enzyme with our ImmTOR platform to develop a product candidate for IgA nephropathy," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta Biosciences. "IGAN's IgA protease has shown tremendous promise in preclinical studies and combining it with ImmTOR to prevent ADAs could lead to a transformational product for patients with this debilitating disease."
CNS

Hot Stocks

16:11 EDT Cohen & Steers reports preliminary AUM $70.5B as of September 30 - A decrease of $1.6B from assets under management at August 31.
GNMK

Hot Stocks

16:10 EDT GenMark ePlex RP2 test receives EUA from FDA - GenMark has received Emergency Use Authorization, or EUA from the FDA for its ePlex Respiratory Pathogen Panel 2, or RP2. In less than two hours, the test provides results for more than 20 viruses and bacteria that cause common and often serious respiratory infections, including COVID-19, flu, bronchitis and the common cold. A multiplex, or syndromic, test, the RP2 Panel provides rapid results for infections with similar symptoms such as fever, cough and body aches, which will be essential in preparing for fall and winter as the flu season coincides with the ongoing risk of COVID-19.
EXTR

Hot Stocks

16:10 EDT Extreme Networks jumps 13% to $4.65 after raising Q1 guidance
EBS

Hot Stocks

16:09 EDT Emergent BioSolutions Covid-19 candidate to be included in NIH sponsored trial - Emergent BioSolutions announced the initiation of the Phase 3 clinical trial that will evaluate plasma-derived therapy COVID-HIG as a potential treatment for hospitalized patients with coronavirus disease, COVID-19. The INSIGHT-013 clinical study called "Inpatient Treatment with Anti-Coronavirus Immunoglobulin, ITAC," is sponsored by the National Institute of Allergy and Infectious Diseases, NIAID, part of the National Institutes of Health, NIH. The study will evaluate the safety, tolerability, and efficacy of hyperimmune globulin products derived from plasma of individuals who have recovered from COVID-19 and have developed neutralizing antibodies to SARS-CoV-2, the virus that causes COVID-19. The randomized controlled clinical trial assigns participants to receive infusions of either a placebo or one of four hyperimmune globulin products, which includes Emergent's COVID-HIG, with a background therapy of remdesivir in all groups. "Emergent is proud to continue our partnership with NIAID/NIH and the Biomedical Advanced Research and Development Authority, BARDA, to advance potential therapeutic solutions for COVID-19 in hospitalized patients," said Dr. Laura Saward, SVP and therapeutics business unit head at Emergent BioSolutions. "We are drawing from decades of experience developing treatments on our well-established hyperimmune platform to address this serious public health threat."
EXTR

Hot Stocks

16:08 EDT Extreme Networks sees Q1 gross margin 'slightly better than original guidance' - The company said, "We expect GAAP and Non-GAAP Gross Margin to be slightly better than original guidance, while we expect GAAP and Non-GAAP Operating Expenses to be in-line with Extreme's prior guidance." "Our first fiscal quarter outlook improved across a number of financial metrics. Our better-than-expected performance is a result of strong bookings and customer response to our 'effortless' strategy. The simplicity of our ExtremeCloud IQ platform, edge switching and Wi-Fi applications, and our end-to-end fabric technology is creating differentiation in the market during a challenging business environment. We are especially pleased with our team's execution, as this marks the second quarter of sequential revenue and EPS growth in our business at a higher level of Non-GAAP profitability," stated Ed Meyercord, President and CEO. "The combination of improving business trends and continued cost and expense control drove solid operating leverage, and in turn strong cash flow. This allowed us to repay $20 million of our $55 million revolving credit facility during the quarter and reduce our net debt by approximately $24 million sequentially - all while maintaining ample liquidity as cash and cash equivalents remained relatively stable compared to the prior quarter," added Remi Thomas, CFO.
TRNO

Hot Stocks

16:08 EDT Terreno Realty reports Q3 quarter-end occupancy 97.3% vs. 96.0% prior quarter - The company states: "As of September 30, 2020, Terreno Realty Corporation owned 219 buildings aggregating approximately 13.1 million square feet and 22 improved land parcels consisting of approximately 85.0 acres. In addition, Terreno Realty Corporation had one property under redevelopment that upon completion will contain approximately 234,000 square feet: The operating portfolio, excluding one property under redevelopment, was 97.3% leased at September 30, 2020 to 476 tenants as compared to 96.0% at June 30, 2020 and 97.2% at September 30, 2019; The same-store portfolio of approximately 12.0 million square feet was 98.5% leased at September 30, 2020 as compared to 96.5% at June 30, 2020 and 98.1% at September 30, 2019. The increase in occupancy as compared to the prior quarter was driven primarily by the commencement of a 192,000 square foot lease at the Company's 130 Interstate property; The improved land portfolio of 22 parcels totaling approximately 85.0 acres was 98.5% leased at September 30, 2020 as compared to 98.5% at June 30, 2020 and 93.2% at September 30, 2019."
REI

Hot Stocks

16:06 EDT Ring Energy says buyer requested extension on Delaware Basin asset deal - Ring Energ provided an update on the sale of its Delaware Basin asset located in Culberson and Reeves Counties, Texas. Ring management stated that the buyer has requested an extension to October 29, 2020, and, as a show of good faith, has wired the company an additional non-refundable $1 million. The company went on to say that the on-going conversations with the buyer and the additional wired funds has continued to provide management with a heightened level of confidence that the transaction will close by the end of the month, however management has made it clear there will be no further extensions.
OYST

Hot Stocks

16:05 EDT Oyster Point chairperson Michael Ackermann steps down, Ali Behbahani succeeds - Oyster Point Pharma announced changes to its board, consistent with the company's strategic evolution. Effective immediately, Ali Behbahani, who has served as a member of Oyster Point's board since July 2017, will step into the role of chairperson of the board, replacing Michael Ackermann, who will step down to focus on new company creation and his positions as CEO of Presidio Medical and chairperson of Tarsus Pharmaceuticals, two earlier-stage healthcare companies. Ackermann will continue to provide Oyster Point his expertise as an external strategic consultant going forward.
PRVL

Hot Stocks

16:04 EDT Citadel Advisors reports 7.0% passive stake in Prevail Therapeutics - Citadel Advisors disclosed a 7.0% stake in Prevail Therapeutics, which represents over 2.41M shares. The filing does not allow for activism.
CONE

Hot Stocks

16:01 EDT CyrusOne names Katherine Motlagh CFO - CyrusOne announced that the company's Board of Directors has elected Katherine Motlagh as Executive Vice President and Chief Financial Officer. Effective October 30, 2020, Motlagh will succeed Diane Morefield, who announced her retirement earlier this year. Morefield will work with Motlagh to ensure a seamless transition, remaining full time with the company until December 31, and then part time through March 1, 2021. Motlagh is currently Chief Financial Officer for the Europe, Africa and Latin America regions at American Tower Corporation, a global infrastructure REIT which develops, owns, and operates multitenant communications real estate.
PLYA

Hot Stocks

15:31 EDT Playa Hotels & Resorts resumes normal operations at Yucatan resorts - Playa Hotels & Resorts has resumed normal operations at its Yucatan resorts, including those managed by AMResorts, subsequent to Hurricane Delta. "We are happy to report that none of our associates nor guests were harmed on the property, or during the evacuation process, and the eventual landfall of the storm only presented us with aesthetic landscaping repairs but with no identifiable structural damage at this time," said Gregory Maliassas, executive VP and COO of Playa Resorts Management.
LUV

Hot Stocks

15:25 EDT Southwest announces winter flight schedule with new destinations - Southwest primed its winter flight schedule with service details for new destinations in Florida, California and in the Colorado Rockies. The carrier announced new seasonal service to Montrose Regional Airport on the Western Slope of Colorado, begins December 19, the same day as previously announced seasonal service to Steamboat Springs. Service to Miami and Palm Springs both will begin November 15. New routes to Miami, Palm Springs and Montrose now available on Southwest.com. The number of seats are limited by days of week and market, from the first date of service through March 4, 2021, if booked by 11:59 p.m. on October 15. Blackout dates apply. Beginning Sunday, November 15, Southwest will offer nonstop service to Miami from Tampa, Baltimore, Houston and Chicago and Palm Springs from Oakland, Phoenix and Denver. Beginning Saturday, December 19 and mirroring the flight schedule previously announced for Steamboat Springs, Southwest will operate new service seasonally through April 5, 2021:As low as $49 one-way nonstop between Montrose and Denver and as low as $79 one-way nonstop between Montrose and Dallas. Southwest also reestablished service to Puerto Vallarta, Mexico, offering the airline's inaugural international nonstop service from Phoenix. The carrier is now operating daily service between Phoenix Sky Harbor International Airport and both Los Cabos and Puerto Vallarta. Southwest flight schedules are currently published through April 11, 2021, offering connecting international service to customers in the majority of its airports across the United States through a dozen gateway airports with international departures: Austin, Baltimore/Washington, Chicago, Denver, Houston, Indianapolis, Nashville, Orlando, Phoenix, Sacramento, St. Louis and Tampa. Southwest currently offers published service to five countries: three cities in Mexico-Cancun, Los Cabos and Puerto Vallarta-Aruba, Montego Bay in Jamaica, Punta Cana in the Dominican Republic and Havana in Cuba. Southwest recently revised its published flight schedule for November and December and added new routes linking existing Southwest cities across the country with nonstop service.
ROKU AMZN

Hot Stocks

15:17 EDT Roku Channel now available on Amazon Fire TV - Roku's (ROKU) Rob Holmes said in a post to the company's blog: "Calling all Amazon Fire TV users! We have some exciting news for you - The Roku Channel, the home for free and premium TV on The Roku platform, will begin rolling out today to Amazon Fire TV streaming devices, Fire TV Edition smart TVs, and Fire TV Edition soundbars in the US. In short, if you have an Amazon Fire TV device in your home, you'll now have access to The Roku Channel's vast library of free entertainment, featuring thousands of ad-supported movies and TV shows, and more." Reference Link
GOOG GOOGL

Hot Stocks

14:53 EDT Google debuts Sound Notifications, Android push notifications for critical sound - Google said in part in an earlier blog posting :"Sound Notifications is a new feature on Android that provides push notifications for critical sounds around you. Designed for the estimated 466 million people in the world with hearing loss, Sound Notifications makes important and critical household sounds more accessible with push notifications, a flash from your camera light, or vibrations on your Android phone. This feature can also be helpful if someone is unable to hear temporarily as a result of an injury, wearing earplugs or headphones...Developed with machine learning, Sound Notifications works completely offline and uses your phone's microphone to recognize ten different noises-including baby sounds, water running, smoke and fire alarms, appliances beeping and door knocking. This expands our sound detection work in Live Transcribe which shows over 30 sound events alongside real time captions, to provide a better picture of overall sound awareness." Reference Link
SURF

Hot Stocks

14:28 EDT Surface Oncology treatment of hepatocellular carcinoma granted orphan status - Surface Oncology's fully human, antagonistic IgG1 monoclonal antibody targeting IL-27 subunit alpha was granted FDA orphan designation as a treatment of hepatocellular carcinoma, according to a post to the agency's website. Reference Link
GME

Hot Stocks

14:23 EDT GameStop up 21.5% to $11.37 after announcing Microsoft cloud partnership
IONS

Hot Stocks

14:21 EDT Ionis Pharmaceuticals treatment of Lafora disease granted orphan status - Ionis Pharmaceuticals' treatment of Lafora disease was granted orphan status by the FDA, according to a post to the agency's website. Reference Link
GME

Hot Stocks

14:21 EDT GameStop trading resumes
RPM

Hot Stocks

14:16 EDT RPM raises dividend 5.6% to 38c per share - RPM International announced at its annual meeting of stockholders that its board of directors declared a regular quarterly cash dividend of 38c per share, payable on October 30 to stockholders of record as of October 19. This payment represents a 5.6% increase over the 36c quarterly cash dividend paid at this time last year, the company stated.
GOOG GOOGL

Hot Stocks

14:09 EDT Waymo opens driverless service to general public in Phoenix - Alphabet's Waymo said that, starting October 8, it is opening up its fully driverless offering to Waymo One riders in Phoenix, Arizona. " In 2017, we began our early rider program in the Metro Phoenix area with the next generation of our technology, using the full-size hybrid Chrysler Pacifica," the company said in a blog post. "This 4th-generation Waymo Driver was significantly more sophisticated than Firefly's technology, and for the last year, has pioneered fully driverless, paid rides on high-speed roads across a service area larger than the city of San Francisco." Reference Link
WDC

Hot Stocks

14:06 EDT Western Digital expands WD_BLACK portfolio for gaming - Western Digital introduded three new and upcoming products for its WD_BLACK portfolio of storage solutions for optimal gaming performance on PC. These include its first NVMe solid-state drive with next-gen PCIe Gen4 technology, a fully bootable Gen3 x8 add-in-card and a Thunderbolt 3-powered NVMe SSD gaming dock, each offering eye-catching RGB lighting options. "As game developers move towards creating immersive titles that require higher performance, consumers need to equip themselves with the best tools to stay up-to-speed," said Jim Welsh, senior vice president, Consumer Solutions, Western Digital. "Innovative, high-performance storage solutions are essential to keep up with this ever-changing landscape. Our latest WD_BLACK products have been purpose-built to allow gamers to meet the increasingly high standards of future games and gaming platforms. We've optimized these products to not only provide more storage for gamers but to elevate the gaming experience as a whole." The WD_BLACK SN850 NVMe SSD non-heatsink version will be available in 500GB, 1TB and 2TB capacities starting at $149.99, while the WD_BLACK D50 Game Dock NVMe SSD is available in a 1TB capacity2 starting at $499.99. A non-SSD option, the WD_BLACK D50 Game Dock, is also available for purchase for $319.99.
MS

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14:06 EDT Morgan Stanley fined $60M by OCC for oversight failures - The Office of the Comptroller of the Currency has assessed a $60M civil money penalty against Morgan Stanley Bank, N.A., and Morgan Stanley Private Bank, N.A. The OCC took these actions based on the banks' failure to exercise proper oversight of the 2016 decommissioning of two Wealth Management business data centers located in the U.S. Among other things, the banks failed to effectively assess or address risks associated with decommissioning its hardware; failed to adequately assess the risk of subcontracting the decommissioning work, including exercising adequate due diligence in selecting a vendor and monitoring its performance; and failed to maintain appropriate inventory of customer data stored on the decommissioned hardware devices. In 2019, the banks experienced similar vendor management control deficiencies in connection with decommissioning other network devices that also stored customer data. The OCC found the noted deficiencies constitute unsafe or unsound practices and resulted in noncompliance. The OCC penalty will be paid to the U.S. Treasury.
AMD

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14:04 EDT AMD unveils Ryzen 5000 Series desktop processors - AMD introdued the Ryzen 5000 Series desktop processor lineup powered by the new "Zen 3" architecture. Offering up to 16 cores, 32 threads and 72 MB of cache in the top-of-the-line AMD Ryzen 9 5950X, AMD Ryzen 5000 series processors dominate in heavily threaded workloads and power efficiency, while the AMD Ryzen 9 5900X processor offers up to a 26% generational uplift in gaming performance, the company said. With extensive improvements throughout the core including a unified 8-core complex with direct access to 32MB L3 cache, the new AMD "Zen 3" core architecture delivers a 19% generational increase in instructions per cycle, the largest since the introduction of "Zen" processors in 2017. "Our commitment with each generation of our Ryzen processors has been to build the best PC processors in the world. The new AMD Ryzen 5000 Series Desktop Processors extend our leadership from IPC, power efficiency to single-core, multi-core performance and gaming," said Saeid Moshkelani, senior vice president and general manager, client business unit, AMD. "Today, we are extremely proud to deliver what our community and customers have come to expect from Ryzen processors - dominant multi-core and single-core performance and true gaming leadership - all within a broad ecosystem of motherboards and chipsets that are drop-in ready for AMD Ryzen 5000 Series Desktop Processors."
GME MSFT

Hot Stocks

14:02 EDT GameStop moves to Microsoft cloud solutions in multi-year partnership - GameStop (GME) announced that it has entered into a multi-year partnership agreement with Microsoft (MSFT). "Through this partnership, GameStop will standardize the Company's business operations on Microsoft's cloud solutions and hardware products to deliver rich new digital experiences to customers, creating the "ultimate gaming destination" for gamers in its vision to be the premier omni-channel customer access point for video game products," the company said in a statement. Under the agreement, GameStop will standardize its back-end and in-store solutions on Dynamics 365. Additionally, its associates will be equipped with new Microsoft Surface devices. "As part of its transformation, GameStop plans to roll out Microsoft 365 and Microsoft Teams to its stores, empowering more than 30,000 store associates with enhanced productivity and collaboration tools," the company added.
GME

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14:00 EDT GameStop trading halted, news pending
BBY

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13:57 EDT Best Buy kicks off Black Friday sales on October 13 - Best Buy said it is kicking off Black Friday sales next week. For two days, on Oct. 13 and 14, shoppers can get dozens of deals straight from the not-yet-released Black Friday ad. The rest of Best Buy's Black Friday ad, and more opportunities to score Black Friday deals, will come later this month, the company said. Reference Link
CNI...

Hot Stocks

13:54 EDT North American rail traffic rose 1% in week ended October 3 - U.S. railroads originated 1,119,546 carloads in September, down 9.7%, or 119,909 carloads, from September 2019. U.S. railroads also originated 1,423,883 containers and trailers in September, up 7.1%, or 94,351 units, from the same month last year. Combined U.S. carload and intermodal originations in September 2020 were 2,543,429, down 1% or 25,558 carloads and intermodal units from September 2019. "September was the fourth best intermodal month in history for U.S. railroads, as retailers and others restocked their inventories and prepared for the holiday season," said AAR Senior Vice President John T. Gray. "Meanwhile, rail carloads, which don't include intermodal, remained down in September compared with last year, but showed marked improvement compared to a few months ago, especially if you exclude coal. In the meantime, railroads remain focused on keeping their employees safe while delivering the goods our nation needs." Total combined U.S. traffic for the first 40 weeks of 2020 was 18,602,163 carloads and intermodal units, a decrease of 10.4% compared to last year. Total U.S. weekly rail traffic was 518,761 carloads and intermodal units, up 0.8% compared with the same week last year. Total carloads for the week ending October 3 were 232,273 carloads, down 5.9% compared with the same week in 2019, while U.S. weekly intermodal volume was 286,488 containers and trailers, up 6.9 percent compared to 2019. North American rail volume for the week ending October 3, on 12 reporting U.S., Canadian and Mexican railroads totaled 330,778 carloads, down 3.8% compared with the same week last year, and 380,792 intermodal units, up 5.7% compared with last year. Total combined weekly rail traffic in North America was 711,570 carloads and intermodal units, up 1%. North American rail volume for the first 40 weeks of 2020 was 25,606,616 carloads and intermodal units, down 9.8 percent compared with 2019. Publicly traded companies in the space include CSX (CSX), Canadian National (CNI), Canadian Pacific (CP), Genesee & Wyoming (GWR), Kansas City Southern (KSU), Norfolk Southern (NSC) and Union Pacific (UNP). Reference Link
ACMR

Hot Stocks

13:39 EDT ACM Research says J Capital Research report 'contains numerous misstatements' - ACM Research responded to the issuance of a report by J Capital Research USA with respect to ACM and its operations. The company said, "The report contains numerous misstatements of historical facts regarding ACM's business and operations, including, among others, errors regarding revenue, tool ASPs, gross margins, key suppliers, inventory, and other balance sheet-related items. ACM expects to release its financial results for the third quarter of 2020 and to host its quarterly earnings conference call in early November 2020. ACM expects to respond in more detail to the report's misstatements during the upcoming earnings call, when ACM's current disclosure quiet period will end."
CURLF

Hot Stocks

13:25 EDT Curaleaf receives approval for acquisition of Alternative Therapies Group - Curaleaf Holdings announced the Massachusetts Cannabis Control Commission has approved the company's previously announced acquisition of Alternative Therapies Group. In August of 2018, Curaleaf entered into an agreement to acquire ATG's 53,600 square foot cultivation and processing facility in Amesbury, Massachusetts. In connection with the acquisition, ATG's dispensaries located in Amesbury, Salisbury and Salem will be spun off and continue to operate under the ATG brand and will be supplied by Curaleaf. Closing of the ATG transaction is expected to be completed in the coming days.
BBQ

Hot Stocks

12:05 EDT Famous Dave's signs 25-unit development deal - Famous Dave's recently signed a 25-unit development agreement to grow the BBQ brand in select locations across the U.S. - adding to its 125 existing locations. The BBQ franchise is partnering with Bluestone Hospitality Group to open both Famous Dave's ghost kitchens and dual restaurant concepts with the group's Italian brand, Johnny Carino's. Famous Dave's is also looking to implement a drive-thru while it focuses on improving current locations and growing into new territories. Famous Dave's of America, Inc. is a wholly owned subsidiary of BBQ Holdings.
FUBO

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12:00 EDT FuboTV falls -8.4% - FuboTV is down -8.4%, or -$1.02 to $11.18.
AYI

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12:00 EDT Acuity Brands falls -10.1% - Acuity Brands is down -10.1%, or -$11.42 to $101.84.
SOL

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12:00 EDT ReneSola falls -10.6% - ReneSola is down -10.6%, or -37c to $3.13.
YALA

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12:00 EDT Yalla rises 12.5% - Yalla is up 12.5%, or $1.01 to $9.09.
JMIA

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12:00 EDT Jumia Technologies rises 17.4% - Jumia Technologies is up 17.4%, or $1.48 to $10.01.
EV

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12:00 EDT Eaton Vance rises 47.8% - Eaton Vance is up 47.8%, or $19.58 to $60.52.
IMMU

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11:44 EDT Immunomedics granted orphan designation for sacituzumab govitecan - Immunomedics was granted FDA orphan designation for sacituzumab govitecan as a treatment of malignant glioma, according to a post to the agency's website. Reference Link
TSHA

Hot Stocks

11:43 EDT Taysha Gene Therapies granted orphan designation by FDA - Taysha Gene Therapies was granted FDA orphan designation for its treatment for Rett syndrome, according to a post to the agency's website. Reference Link
JNJ

Hot Stocks

11:42 EDT Janssen's daratumumab SC receives orphan designation status from FDA - According to the FDA, Janssen's daratumumab SC, a treatment of light-chain amyloidosis, has received orphan designation status. The drug has not been FDA approved for orphan indication. Reference Link
LLY INCY

Hot Stocks

11:42 EDT Eli Lilly, Incyte: Baricitinib has effect on COVID-19 patients requiring oxygen - Eli Lilly and Company (LLY) and Incyte (INCY) shared additional data showing baricitinib in combination with remdesivir reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with remdesivir. This finding was part of additional efficacy and safety data from the Adaptive COVID-19 Treatment Trial sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health presented today by John Beigel, M.D., associate director for clinical research in the Division of Microbiology and Infectious Diseases at NIAID. These data were presented at a special International Society for Influenza and other Respiratory Virus Diseases Antiviral Group Virtual Conference on 'Therapeutics for COVID-19.' The largest benefits were observed in patients requiring supplemental oxygen and those who required high-flow oxygen/non-invasive ventilation at baseline. A numerical decrease in death through Day 29 was observed in patients treated with baricitinib plus remdesivir compared to remdesivir in the overall population. The reduction in mortality was more pronounced for patients receiving oxygen, as mortality at Day 29 was 60% lower and 43% lower for the OS5 and OS6 subgroups respectively. No new safety signals were observed for baricitinib-treated patients in this study. NIAID authors are working to have the full analysis completed and a peer-reviewed manuscript will be made available soon.
AMZN

Hot Stocks

11:39 EDT Amazon unveils electric delivery van created with Rivian - In a blog post, the company said, "Just a year since announcing The Climate Pledge, Amazon is excited to reveal its first custom electric delivery vehicle, designed and built in partnership with Rivian. In support of The Climate Pledge commitment to be net zero carbon by 2040, 10,000 Amazon custom electric delivery vehicles will be on the road delivering to customers worldwide as early as 2022 and all 100,000 by 2030. This is one of three different models that Amazon has invested in and completely customized with Rivian to enhance the driver experience and optimize safety...Amazon's custom electric vehicle is packed with industry leading safety, navigation and design features, including: State-of-the-art sensor detection, a suite of highway and traffic assist technology, and a large windshield to enhance driver visibility. Exterior cameras around the vehicle that are linked to a digital display inside the cabin, giving the driver a 360-degree view outside the vehicle. Alexa integration for hands-free access to route information and the latest weather updates. A strengthened door on the driver's side for additional protection. A "dancefloor" inside the driver's cabin for easy movement inside the van. Bright tail lights surrounding the rear of the vehicle to easily detect braking. Three levels of shelving with a bulkhead door, which can easily be opened and closed for additional driver protection while on the road...In support of The Climate Pledge, Amazon is committed to creating a delivery fleet that helps reach its goal to be net zero carbon across its operations by 2040." Reference Link
VIACA VIAC

Hot Stocks

11:27 EDT CBS announces brand refresh across all divisions, platforms - CBS has unveiled a new brand identity that "evolves, simplifies and elevates the look and feel of all its divisions across platforms while creatively featuring iconic elements of the brand's rich history," announced by President and CMO Mike Benson. The updated brand identity for entertainment programming debuted on the Network this week in advance of the upcoming fall season. Viewers can expect to see it rolled out across CBS News leading up to the 2020 election and for CBS Sports by the Network's broadcast of Super Bowl LV on Sunday, Feb. 7, 2021. Similar iterations are being developed for CBS Television Stations and CBS Television Distribution. The company said, "New elements of the CBS brand strategy and its evolved look, feel and sound: The iconic CBS Eye will be used across the brand identity in a flexible style that elevates it as a standalone logo and leans into the shapes and elements that make it up - separating and rejoining in unity via lively animation. Brand attribution will be applied to programming and promotion that drives better connection between the CBS core brand, its sub-brands and our premium content available across CBS-owned and third-party platforms. Content on CBS and CBS-owned platforms will be tagged with 'CBS Original,' 'CBS News,' 'CBS Sports' or 'CBS Presents' to reinforce its role as a leading creator and content provider for its platforms and many others. Content produced by CBS Studios will also include "A CBS Studios Production" and CBS Studios branded marks. An audio expression of the updated brand identity comes to life in a five-note mnemonic written by assigning musical notes to the historic 'This is CBS' voiceover slogan, creating a new melody and animation that will appear at the top of the hour during primetime programming on CBS. Unified logos and graphics that simplify and closely identify CBS as the core brand across divisions. Updated avatars and watermarks to be used across all CBS social media handles. "
RHHBY

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11:23 EDT Roche's Genentech granted orphan designation for Atezolizumab - Roche's Genentech was granted orphan designation from the FDA for Atezolizumab as a treatment of soft tissue sarcoma, according to a post to the agency's website. Reference Link
UNVR

Hot Stocks

11:14 EDT Biosynthetic Technologies, Univar enter distribution agreement for BioEstolides - Biosynthetic Technologies announced a distribution partnership with Univar Solutions for Europe, Middle East and Africa. This partnership will extend Biosynthetic Technologies' footprint for the personal care market outside of the U.S. market to meet the demand for biobased personal care ingredients with its' BioEstolides product line. Biosynthetic Technologies entered in a distributor agreement with Univar Solutions for the USA earlier this year. Under the terms of the new agreement, Univar Solutions will market, sell, warehouse and support Biosynthetic Technologies full BioEstolide product portfolio starting September 30, 2020.
BFRA

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11:08 EDT Biofrontera reports completion of clinical phase of pharmacokinetics study - Biofrontera reports the completion of the clinical phase of the pharmacokinetics study to test the safety of photodynamic therapy using three tubes of Ameluz at the same time. The maximal use PK study included a total of 32 patients with extended fields of actinic keratosis who received one PDT treatment with a total of three tubes of Ameluz either on the face/scalp, or on extremities/trunk/neck. Ameluz was applied in accordance with the currently licensed protocol, except that three tubes of the drug were used to cover a total skin area of 60 cm, which could be either in one continuous or two separate fields. Illumination was performed after 3 hours of occlusion, using either one or two BF-RhodoLED lamps, depending on number and localization of the treatment area. The study was carried out in one specialized dermatological phase I unit in Texas/USA. The primary endpoint of the study is to obtain pharmacokinetics profiles in the subjects' blood when three tubes of Ameluz are applied. The assessment of systemic bioavailability of drugs and metabolites that are applied to the skin and intended for local action at the application site is mandatory within the framework of FDA regulations. In addition, safety and tolerability of Ameluz PDT with three tubes are assessed under maximal use conditions as a further important endpoint. These data aid to understand the safety profile and to describe treatment related side effects, such as local skin reactions on both face/scalp and extremities/trunk/neck. Following the completion of the clinical phase, Biofrontera expects to receive the results on both pharmacokinetics and safety during Q4 2020. The Company aims at a regulatory submission to expand the existing license to include the use of up to three tubes of Ameluz for the lesion-directed and field-directed treatment of mild to moderate actinic keratoses on the face and scalp in combination with the BF-RhodoLED lamp.
GDRX KR

Hot Stocks

11:02 EDT GoodRx, Kroger Health announce renewal agreement - GoodRx (GDRX) announced it had agreed with Kroger Health - the healthcare division of The Kroger Co. (KR) - to a three-year renewal of their relationship, "enabling customers across the country to continue to use the Kroger Rx Savings Club program to help reduce costs for prescription drugs." Jim Sheninger, GoodRx's Pharmacy Strategy Officer, said, "Kroger is the largest supermarket chain in the U.S. and is visited by millions of consumers every day, so we're proud to continue working together to further our mission of providing Americans with access to affordable and convenient healthcare."
REGN

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10:40 EDT Regeneron submits request to FDA for EUA of COVID-19 antibody combination - In a statement issued last night, Regeneron said: "Subsequent to our discussions with regulatory authorities, we have submitted a request to the U.S. Food and Drug Administration for an Emergency Use Authorization, or EUA, for our REGN-COV2 investigational antibody combination for COVID-19. Under our agreement with the U.S. government for the initial doses of REGN-COV2, if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution. At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months." Reference Link
LLY

Hot Stocks

10:36 EDT Lilly provides additional details on SARS-CoV-2 neutralizing antibody programs - Eli Lilly and Company announced additional details on its SARS-CoV-2 neutralizing antibody programs - including interim data on combination therapy in recently diagnosed patients with mild- to moderate COVID-19 - and plans to make these therapies broadly available to patients. Data from a new interim analysis of the BLAZE-1 clinical trial showed that combination therapy with two of Lilly's SARS-CoV-2 neutralizing antibodies reduced viral load, symptoms, and COVID-related hospitalization and ER visits. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555 and LY-CoV016, which bind complementary regions of the SARS-CoV-2 spike protein, for the treatment of symptomatic COVID-19 in the outpatient setting. The combination cohort enrolled recently diagnosed patients with mild- to moderate COVID-19, who were assigned to 2800 mg of each antibody or placebo. The combination therapy significantly reduced viral load at day 11, meeting the primary endpoint of the study. Most patients, including those receiving placebo, demonstrated near complete viral clearance by day 11. Further, combination treatment reduced viral levels at day 3 and day 7-earlier time points during the course of infection when higher viral loads are typically seen. Combination therapy also significantly reduced the time-weighted average change from baseline from day 1 to 11. An exploratory analysis showed that the proportion of patients with persistent high viral load at day 7 for combination therapy was lower versus placebo, corresponding to a nominal p value of pless than0.0001 without multiplicity adjustment. No emergent putative resistance variants have been observed thus far in patients treated with combination therapy. Combination therapy also met prespecified clinical endpoints, including the time-weighted average change from baseline in total symptom score from day 1 to 11. The improvement in symptoms was observed as early as three days after dosing and was similar in magnitude and timing to improvements previously seen with LY-CoV555 monotherapy. The rate of COVID-related hospitalization and ER visits was lower for patients treated with combination therapy versus placebo, a relative risk reduction of 84.5 percent. This was also similar to observations for LY-CoV555 monotherapy. Combination therapy has been generally well tolerated with no drug-related serious adverse events. In LY-CoV555 monotherapy studies there have been isolated drug-related infusion reactions or hypersensitivity that were generally mild (two reported as serious infusion reactions, all patients recovered). Treatment-emergent adverse events were comparable to placebo for both LY-CoV555 monotherapy and combination therapy. Lilly is working to publish the monotherapy and combination therapy data in peer-reviewed journals as soon as possible. To be able to quickly provide treatment to patients around the world, Lilly invested in large-scale manufacturing of both antibodies at risk - even before data demonstrated their potential to become a meaningful therapeutic option for COVID-19. For monotherapy, Lilly is focused on the 700 mg dose of LY-CoV555 since similar clinical effects were seen across all dose levels tested in BLAZE-1. Lilly anticipates it could supply as many as one million doses of 700 mg LY-CoV555 monotherapy in Q4 2020, with 100,000 available in October. With respect to the supply of combination therapy, Lilly anticipates it will have 50,000 doses available in Q4 2020. The supply of combination therapy will increase substantially beginning in Q1 2021, as additional manufacturing resources come online throughout the year, including Lilly's recently announced manufacturing collaboration with Amgen (AMGN). Lilly is also pursuing additional partnerships to provide antibodies to resource-limited countries. Based on the combination therapy data, along with the previously disclosed findings for LY-CoV555 monotherapy, Lilly has engaged global regulators, including the FDA, regarding potential Emergency Use Authorization. Lilly has now submitted an initial request to the FDA for EUA for LY-CoV555 monotherapy in higher-risk patients who have been recently diagnosed with mild- to moderate COVID-19. We expect to submit a subsequent request for EUA for combination therapy in November, pending clinical trial enrollment, once additional safety data accumulate and sufficient supply is manufactured. Lilly anticipates having data to support a biologics license application submission for combination therapy as early as Q2 2021. Conversations with global regulators, including Health Canada, are ongoing. The BLAZE-1 clinical trial continues to enroll a confirmatory cohort of higher-risk patients who have been recently diagnosed with mild- to moderate COVID-19, testing the ability of the antibody combination to reduce the number of patients with persistently high viral load and reduce COVID-related hospitalizations. In addition, Lilly is studying lower doses of combination therapy and alternative delivery options in planned or ongoing clinical trials. Other ongoing clinical trials include a Phase 3 study of LY-CoV555 monotherapy for the prevention of COVID-19 in residents and staff at long-term care facilities. In addition, LY-CoV555 monotherapy is being tested in the National Institutes of Health-led ACTIV-2 and ACTIV-3 studies of ambulatory and hospitalized COVID-19 patients. Data from these other ongoing trials are not yet available. Thus far, over 850 trial participants have been dosed with LY-CoV555, contributing to the safety data supporting this potential treatment. To generate additional efficacy and safety data, Lilly plans to initiate a pragmatic, open-label study in the coming weeks, enrolling patients treated with either monotherapy or combination therapy, with a focus on collecting data regarding hospitalizations, deaths and safety. Moving forward, LY-CoV555 and LY-CoV016 will be referred to as bamlanivimab and etesevimab, respectively.
RDHL AZN

Hot Stocks

10:32 EDT RedHill Biopharma adds Israel rights to Movantik from AstraZeneca - RedHill Biopharma (RDHL) announced that it has gained the rights to Movantik in Israel from AstraZeneca (AZN). RedHill now holds the worldwide rights to Movantik, excluding Europe and Canada. Movantik is approved in Israel, under the brand name Moventig, for the treatment of opioid-induced constipation but is not yet commercialized. RedHill is evaluating the potential for a local commercialization partnership for Movantik in order to bring this OIC treatment to patients in Israel. "Our commercial focus for Movantik remains firmly fixed on the U.S., where we have sole and exclusive commercialization rights. We have built a strong and expanding commercial team to support Movantik, which despite the challenging COVID-19 pandemic environment generated approximately $20M in net revenue in the second quarter of 2020 - its first quarter as a RedHill product." said Adi Frish, Senior Vice President Business Development and Licensing at RedHill.
DPZ

Hot Stocks

10:27 EDT Domino's Pizza sees FY20 G&A expense $405M-$410M
DPZ

Hot Stocks

10:27 EDT Domino's Pizza resassessing timing of 25,000 stores opened by 2025 goal - Comments taken from Q3 earnings conference call.
SAH

Hot Stocks

10:17 EDT Sonic Automotive sinks after CEO arrested, charged with assaulting a female - Shares of Sonic Automotive are lower in Thursday morning trading after the company's CEO, David Bruton Smith, was arrested on several charges Monday, including assault by strangulation, assault on a female, false imprisonment and interfering with emergency communications, according to records publicly available from the Mecklenburg County Jail. The jail's records indicate that Smith was released on Tuesday, October 6. The official arrest report states the victim was a 22-year-old woman who told officers Smith "assaulted an unlawfully restrained her without her consent," according to a report from WBTV 3. When reached for comment about the arrest, a Sonic Automotive spokesperson released the following statement to local news station WBTV 3: "The Board of Directors of Sonic Automotive remains steadfast in its support of our CEO, David Smith. We believe in David's leadership, honesty and transparency, which he has demonstrated throughout his tenure as Chief Executive Officer and over 20 years of service to the Company. David has informed the Board that he is innocent of these charges and expects to be fully exonerated." In Thursday morning trading, shares of Sonic Automotive are down $2.41, or 5.35%, to $42.56. Reference Link
DPZ

Hot Stocks

10:00 EDT Domino's Pizza falls -6.2% - Domino's Pizza is down -6.2%, or -$26.83 to $404.22.
RENN

Hot Stocks

10:00 EDT Renren falls -7.9% - Renren is down -7.9%, or -38c to $4.40.
SOL

Hot Stocks

10:00 EDT ReneSola falls -9.7% - ReneSola is down -9.7%, or -34c to $3.16.
UMC

Hot Stocks

10:00 EDT UMC rises 10.3% - UMC is up 10.3%, or 54c to $5.77.
LEAF

Hot Stocks

10:00 EDT Leaf Group rises 11.5% - Leaf Group is up 11.5%, or 74c to $7.16.
EV

Hot Stocks

10:00 EDT Eaton Vance rises 46.3% - Eaton Vance is up 46.3%, or $18.96 to $59.90.
BAX

Hot Stocks

09:53 EDT Baxter withdrew 510(k) applications to FDA for new Novum IQ infusion platform - In a regulatory filing, Baxter International disclosed that in fourth quarter 2019 the company submitted three 510(k) applications for its new Novum IQ infusion platform to the U.S. Food & Drug Administration. The applications cover the NOVUM IQ Large Volume Pump, the NOVUM IQ Syringe Pump and Dose IQ Safety Software. Following discussions with FDA the week of September 28, 2020, the company elected to withdraw its applications on October 2, 2020 in advance of the deadline for FDA's completion of its review of the applications in accordance with the Medical Device User Fee Amendments, the company disclosed. "The company did so in the interest of being able to close out open items on the applications and is working collaboratively with FDA to update its submissions with additional technical information and documentation. The company currently intends to submit its updated 510(k)s no later than December 31, 2020. Baxter remains confident in the fundamentals of the Novum IQ platform. To date, Health Canada has approved the NOVUM LVP for distribution in Canada. Baxter plans to provide additional details regarding the anticipated timing and nature of these updated submissions on its upcoming earnings call for third quarter 2020, currently scheduled for October 29," Baxter said.
DKS

Hot Stocks

09:52 EDT Dick's Sporting to hire up to 9,000 seasonal associates - Dick's Sporting announced it will hire up to 9,000 associates for the 2020 holiday season. DICK'S third-annual "National Signing Day" on October 14 launches the company's recruiting efforts for positions nationwide. All Dick's Sporting Goods, Golf Galaxy and Field & Stream store locations and the company's distribution centers will be closed on Thanksgiving Day, November 26, allowing teammates to spend the holiday with their families. Black Friday offers will be available on Thanksgiving Day at dicks.com, golfgalaxy.com and fieldandstreamshop.com with stores re-opening on Black Friday to serve customers nationwide.
CCL CUK

Hot Stocks

09:24 EDT Carnival CFO: Company to return to 'investment grade credit rating over time' - Carnival Corporation & plc CFO and Chief Accounting Officer David Bernstein noted, "As of the end of the Third Quarter, we had over $8 billion of available cash and additional financing alternatives to opportunistically further improve our liquidity profile. We have recently begun to optimize our capital structure with the early extinguishment of debt on favorable economic terms and the extension of debt maturities. In addition, with the re-launch of our fleet, we saw a good opportunity to improve our balance sheet with an equity offering. So last month we announced an at-the-market or ATM equity offering program. However, once we fully resume guest cruise operations, we expect our cash flow potential will build a path to further strengthen our balance sheet and return us to an investment grade credit rating over time." Due to the pause in guest operations, the company has taken significant actions to preserve cash and secure additional financing to increase its liquidity. Since March, the company has raised $12.5B through a series of financing transactions.
WTRH

Hot Stocks

09:24 EDT Waitr Holdings shares move up after announcing the addition of dine in function - Shares of Waitr Holdings are up 2% in pre-market trading to $3.75 per share after announcing that it has launched tableside service technology for restaurants. Through the scanning of a QR code on a smartphone, the new product allows diners to access the menu from the table, place an order, pay and tip all in the Waitr app without contact. "Contactless service has become increasingly important amid the pandemic for safety reasons. This new product will serve the need of restaurants that are bolstering their safety protocol, and will help make diners feel safer since the ordering process is contact free," said Carl Grimstad, CEO and chairman of the Board of Waitr. "This product also has the potential to increase the number of times a table can turnover due to the lack of waiting on the diner side." Grimstad continued, "Waitr is diversifying its' product offerings to include a further integrated payment solution that with my experience in the payments industry is of great importance today. I believe this is a natural next step to better position Waitr for the long term, and best support our restaurant partners in these trying times and beyond." Since Mr. Grimstad has taken over at Waitr in January 2020, Waitr has quickly implemented many strategic initiatives around service and profitability. Waitr also began delivering same-day groceries, offering No-Contact delivery for all restaurant and grocery orders and now Dine-In service capabilities.
CCL CUK

Hot Stocks

09:20 EDT Carnival sees Q4 monthly average cash burn rate approximately $530M - As of August 31, the company has a total of $8.2B of cash and cash equivalents. Currently, the company is unable to predict when the entire fleet will return to normal operations, and as a result, unable to provide an earnings forecast. The pause in guest operations continues to have a material negative impact on all aspects of the company's business, including the company's liquidity, financial position and results of operations. The company expects a net loss on both a U.S. GAAP and adjusted basis for the quarter and year ending November 30. The company's monthly average cash burn rate for the third quarter 2020 was $770 million, which was in line with the anticipated monthly cash burn rate. The company expects the monthly average cash burn rate for the fourth quarter of 2020 to be approximately $530 million. This results in an average monthly burn rate for the second half of the year of $650 million as previously disclosed. This rate includes approximately $250 million of ongoing ship operating and administrative expenses, working capital changes (excluding changes in customer deposits), interest expense and committed capital expenditures (net of unfunded export credit facilities) and also excludes scheduled debt maturities as well as other cash collateral to be provided. The company continues to explore opportunities to further reduce its monthly cash burn rate. The company estimates non-newbuild capital expenditures during the fourth quarter of 2020 to be approximately $130 million
CSSE

Hot Stocks

09:20 EDT Chicken Soup for the Soul's Screen Media acquires rights to 'Skyfire' movie - Chicken Soup for the Soul Entertainmentannounced that Screen Media has acquired all North American rights to Simon West's big-budget action/disaster film Skyfire and will release the film in theaters and on demand in December 2020.
WTER

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09:19 EDT Alkaline Water appoints Frank Lazaran to board of directors - The Alkaline Water Company announced the appointment of Frank Lazaran to its board of directors, effective October 8, 2020. Lazaran will serve on the Company's audit and compensation committees. Simultaneous to Lazaran's appointment, the Company announces that Bruce Leitch has decided to step down from the Company's board of directors. Leitch is leaving the board to focus on other business endeavors. Lazaran was most recently the Chairman, CEO, and President of Marsh Supermarkets, Inc., a multi-format regional food retailer based in Indianapolis, Indiana.
CCL CUK

Hot Stocks

09:18 EDT Carnival expects to dispose of 18 ships - The company expects future capacity to be moderated by the phased re-entry of its ships, the removal of capacity from its fleet and delays in new ship deliveries. Since the pause in guest operations, the company has accelerated the removal of ships in fiscal 2020 which were previously expected to be sold over the ensuing years. The company now expects to dispose of 18 ships, ten of which have already left the fleet. In total, the 18 ships represent approximately 12 percent of pre-pause capacity and only three percent of operating income in 2019. The sale of less efficient ships will result in future operating expense efficiencies of approximately two percent per available lower berth day and a reduction in fuel consumption of approximately one percent per ALBD. The company expects only two of the four ships originally scheduled for delivery in 2020, following the start of the pause, to be delivered prior to the end of fiscal 2020, including Enchanted Princess which was delivered last week. The company currently expects only five of the nine ships originally scheduled for delivery in fiscal 2020 and 2021 to be delivered prior to the end of fiscal year 2021. The company currently expects nine cruise ships and two smaller expedition ships of the 13 ships originally scheduled for delivery prior to the end of fiscal year 2022 to be delivered by then. Based on the actions taken to date and the scheduled newbuild deliveries through 2022, the company's fleet will be more efficient with a roughly 13 percent larger average berth size per ship and an average age of 12 years in 2022 versus 13 years, in each case as compared to 2019.
UPS

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09:17 EDT UPS' Ware2Go announces combined warehouse management system FulfillmentVu - Ware2Go announced FulfillmentVu, "a new technology platform with a combined warehouse management system, order management system, and transportation management system that empowers merchants of all sizes to easily meet customer expectations across all sales channels to drive revenue growth," said the company. Integration points across any sales channel, eCommerce storefront, or ERP allow for further standardization across Ware2Go's extensive warehouse network and enable merchants to fully customize their fulfillment operations with little to no oversight or operational burden. The Fly notes that Ware2Go is a UPS company, operates a turnkey nationwide fulfillment network designed to help merchants easily position products closer to end customers for a fast, inexpensive, and reliable order-to-delivery experience.
CCL CUK

Hot Stocks

09:17 EDT Carnival says advanced bookings for 2H21 at 'higher end' of historical range - Carnival said, "While the company believes bookings in the first half of 2021 reflect expectations of the phased resumption of its guest cruise operations and anticipated itinerary changes, as of September 20, 2020, cumulative advanced bookings for the second half of 2021 capacity currently available for sale are at the higher end of the historical range. The company believes this demonstrates the long-term potential demand for cruising. Pricing on these bookings are lower by mid-single digits versus the second half of 2019, on a comparable basis, reflecting the effect of future cruise credits from previously cancelled cruises being applied. The company continues to take bookings for both 2021 and 2022. The company is providing flexibility to guests with bookings on sailings cancelled by allowing guests to receive enhanced FCCs or elect to receive refunds in cash. Enhanced FCCs increase the value of the guest's original booking or provide incremental onboard credits. As of September 20, 2020, approximately 45 percent of guests affected by the company's schedule changes have received enhanced FCCs and approximately 55 percent have requested refunds. Total customer deposits balance at August 31, 2020, was $2.4 billion, the majority of which are FCCs, compared to total customer deposits balance of $2.9 billion at May 31, 2020. The decline in customer deposits is consistent with previous expectations. As of August 31, 2020, the current portion of customer deposits was $2.1 billion with $0.1 billion relating to fourth quarter sailings. Approximately 60 percent of bookings taken during the three weeks ended September 20, 2020 were new bookings as opposed to FCC re-bookings, despite minimal advertising or marketing."
MKGI

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09:13 EDT Monaker Group releases Maupintour mobile apps on Apple App, Google Play - Monaker Group announced the launch of its mobile apps allowing travelers and customers the versatility to explore Maupintour's global individual tour packages, and book vacation home rentals on the Apple App and Google Play stores. This follows the launch of the new Maupintour.com website and Monaker's initiatives to re-energize the historic Maupintour brand.
CETX

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09:11 EDT Cemtrex receives $500,000 upgrade order in Advanced Technology Segment - Cemtrex has received a $500,000 order to upgrade a security technology system through its Advanced Technology Segment for a large Tennessee based corrections facility. The mission-critical enterprise-class system is an upgrade from Cemtrex's legacy system to its latest offering, which includes a state-of-the-art video surveillance security system, Valerus software solution, cameras and related storage hardware.
RICK

Hot Stocks

09:10 EDT RCI Hospitality reports Q4 club and restaurants sales - RCI Hospitality reported sales for its Nightclubs and Bombshells restaurants for Q4. Results reflect continued rebound from April when all locations were closed due to the Covid-19 pandemic. Total club and Bombshells sales of $28.4M in Q4 were up 98.5% from Q3 with 24 locations open the duration of the quarter and 44 by period end. FY20 club and Bombshells sales totaled $130.3M. Bombshells sales of $15.5M in Q4 were up 82.1% from Q3 with 8 of 10 locations open the duration of the quarter. FY20 Bombshells sales totaled $43.2M. SSS increased 50.4% and 18.3% for Q4 and FY20, respectively, from the prior year. Club sales of $12.9M in Q4 were up 122.7% from Q3 with 16 locations open the duration of the quarter and 34 by period end. FY20 club sales totaled $87.1M. SSS declined 13.2% and 9.0% for Q4 and FY20, respectively, from the prior year. 46 of 48 locations are currently open.
SYKE

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09:10 EDT Sykes Enterprises appoints David Brain as CDO - Sykes Enterprises announced the appointment of David Brain as chief digital officer, effective immediately. As CFO Brain will be responsible for reconstituting and leading SYKES' portfolio of best-in-class digital capabilities gained largely through strategic acquisitions under one roof. Since co-founding Symphony Ventures in 2014, which was later acquired by SYKES, Brain has specialized in developing innovative solutions that leverage Intelligent Automation and Robotic Process Automation to digitize the back, middle and front office operations of enterprises.
VZ

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09:08 EDT Verizon rolls out 5G Innovation Hub as University of Illnois Research Park - Verizon Business continues to accelerate the development of real-world 5G use cases with the rollout of its latest 5G Innovation Hub at the University of Illinois Research Park. Students, startups and large corporations will now be able to develop and test 5G-enabled solutions at the Research Park's headquarters. The Research Park, a technology innovation hub for startups and corporate R&D operations, is home to more than 120 companies employing students and full-time tech professionals. It is located on campus at the University of Illinois at Urbana-Champaign. Verizon 5G Ultra Wideband service at the Innovation Hub will drive new research and development around using 5G for machine learning, IoT, robotics, artificial intelligence, guided vehicles, drones, manufacturing process automation, virtual reality, data analytics and more.
CSX XON

Hot Stocks

09:08 EDT CSX appoints Thomas Bostick to board of directors - CSX Corp. (CSX) announced that Lt. General Thomas Bostick has been appointed to the company's board of directors, effective immediately. Bostick served in the U.S. Army for 38 years. He served as the Chief of Engineers and Commanding General of the U.S. Army Corps of Engineers. After retiring from the military, Bostick was COO of Intrexon and President of Intrexon Bioengineering (XON).
ALGT

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09:07 EDT Allegiant Travel reports Q3 traffic down 47% y-o-y - Allegiant Travel reported preliminary passenger traffic results for September and Q3. For scheduled service, in September, passengers were down 38.3%, revenue passenger miles were down 36.6%, available seat miles were down 9%, load factor was down 25 points, vs. September 2019. For scheduled service in Q3, passengers were down 46.6%, revenue passenger miles were down 45.9%, available seat miles were down 6.5%, load factor was down 36.3 points, vs. 3Q19. For total system, in September passengers were down 39.6%, available seat miles were down 14.1%, vs. September 2019. For total system, in Q3, passengers were down 47%, available seat miles were down 9.4%, vs. 3Q19. "Average daily cash burn came in at roughly $1.3M for Q3," stated CFO Gregory Anderson. "Gross bookings for the quarter averaged more than $2.0M per day, which is better than our previous booking levels of less than $2M per day, due primarily to steady improvements in bookings throughout the month of September. During Q3, we paid approximately $15M to Sixth Street Partners in conjunction with the termination of the Sunseeker loan agreement, which drove cash burn up slightly. As previously stated, our cash burn figure includes debt payments. We continue to expect Q4 daily cash burn to be well below $1M based on the assumption of average daily gross bookings of more than $2.0M, which is inclusive of the remaining $5M payment to Sixth Street Partners. "As we enter the final quarter of the year, we meaningfully increased our liquidity position to over $850M, primarily driven by the $84M in senior secured debt backed by two A320 aircraft and eight CFM engines along with the sale of $150M of senior secured notes, which is backed by collateral pledged to our existing Term Loan. We believe this improved liquidity coupled with our industry-best cash burn rate not only bolsters liquidity further, but provides enhanced flexibility to best respond to the fluid environment."
AVD

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09:06 EDT American Vanguard acquires Australian crop protection firm - American Vanguard announced that its wholly-owned subsidiary American Vanguard Australia Pty Ltd has acquired all shares of the Australian specialist agrochemical company, AgNova Technologies Pty Ltd. Details of the transaction were not disclosed. AgNova is focused on serving customers primarily in the value-added fruit and vegetables segment of the Australian market. It has a growing product portfolio and ample R&D resources to create a pipeline of tailored solutions to meet the needs of Australian growers.
GDDY

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09:06 EDT GoDaddy launches Over app in 12 new languages - GoDaddy announced its award-winning Over app is now available in 12 new languages: Danish, Dutch, Finnish, French, German, Indonesian, Italian, Norwegian, Portuguese (Brazil), Portuguese (Portugal), Spanish, and Swedish. Over by GoDaddy provides the tools small businesses need to enhance their brands and promote their products and services by easily creating impactful visual content on a mobile device for any platform online.
TGEN

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09:05 EDT Tecogen announces additional sales of TecoChill systems - Tecogen announced multiple sales of TecoChill STx series chillers, including a 200 ton TecoChill for a school in Connecticut, and two 150 ton TecoChill units to a public works utility in Virginia. These systems will provide a total of 500 tons of natural gas engine driven cooling and reduce electric demand by 300 kW using inexpensive natural gas instead of electricity. By using the free heat recovery from the TecoChill systems, the aggregate greenhouse gas reduction potential from the projects is estimated to be approximately 150 tons of CO2 per year.
SQ

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09:05 EDT Square invests $50M in 4,709 bitcoins - Square announced that it has purchased approximately 4,709 bitcoins at an aggregate purchase price of $50M. Square believes that cryptocurrency is an instrument of economic empowerment and provides a way for the world to participate in a global monetary system, which aligns with the company's purpose. The investment represents approximately 1% of Square's total assets as of the end of Q2.
NAOV

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09:05 EDT NanoVibronix receives positive Nasdaq listing determination - NanoVibronix announced that the company has received formal notification that the Nasdaq Hearings Panel has granted the Company's request for continued listing on The Nasdaq Capital Market pursuant to an extension through December 15, 2020, to evidence compliance with the minimum $2.5 million stockholders' equity requirement set forth in Nasdaq Listing Rule 5550(b) for continued listing on The Nasdaq Capital Market. As previously disclosed, the Company earlier received notice from the Listing Qualifications Staff of The Nasdaq Stock Market LLC indicating that the Company no longer satisfied the Rule and was therefore subject to delisting. In response, the Company timely requested a hearing before the Panel, which request stayed any further action by the Staff. The hearing was held on September 24, 2020.
BYND

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09:04 EDT Beyond Meat introduces Beyond Breakfast Sausage Links at stores nationwide - Beyond Meat announced the addition of Beyond Breakfast Sausage Links to its line of plant-based meat offerings.Beyond Breakfast Sausage Links have no GMOs, bioengineered ingredients, synthetic colors, hormones, antibiotics or cholesterol, and have 40% less sodium than a leading brand of traditional pork breakfast sausage links. Beyond Breakfast Sausage Links will roll into grocery stores nationwide, including at select Kroger, Albertsons, Sprouts, Harris Teeter, Wegmans, Whole Foods Market and more throughout October. Sold in the meat case with a suggested retail price of $5.99 for eight links, Beyond Breakfast Sausage Links feature a signature blend of savory herbs and spices.
OTEX

Hot Stocks

09:03 EDT OpenText expands electronic signature offering - OpenText announced that it has expanded its electronic signature offering, which is now available to small and medium-sized businesses, large enterprises and developers. The offering includes a full feature, low-cost option of Core Signature for small and medium-sized businesses and the Core Signature Service for developers looking to integrate e-signature into custom-built applications.
TWLO CRM

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09:03 EDT Twilio announces Jeremiah Brazeau as CTO - Twilio (TWLO) announced that Jeremiah Brazeau will join the company as its CTO. As CTO, Brazeau will be responsible for leading Twilio's technology strategy and roadmap. With this hire, Twilio brings its technology architecture, platform, and data design, under one leader. Brazeau will report directly to Twilio chief product officer Chee Chew. Prior to Twilio, Brazeau was a senior vice president and distinguished architect at Salesforce (CRM), where he led a team of engineers and software architects to deliver scalable and secure SaaS solutions.
QLGN

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09:02 EDT Qualigen Therapeutics enters agreement with Yi Xin Zhen Duan Jishu - Qualigen Therapeutics announces it has entered into an agreement with Yi Xin Zhen Duan Jishu Ltd, of Suzhou, China to develop, manufacture and sell new generations of diagnostic test systems based on Qualigen's core FastPack "laboratory in a pouch" technology. In addition, Yi Xin Zhen Duan Jishu will have the rights to manufacture and sell Qualigen's current generations of rapid point-of-care FastPack diagnostic products in China. Under the terms of this agreement, Qualigen is to receive net cash payments this quarter and next quarter totaling in the mid- to high-hundreds of thousands of dollars, plus low- to mid-single-digit royalties on net sales. Qualigen will provide technology transfer and patent/know-how license rights to facilitate Yi Xin's development and commercialization.
JUSHF

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09:02 EDT Jushi Holdings' BEYOND/HELLO to enter California - Jushi Holdings announced it will enter California with the opening of its 11th retail location nationally: BEYOND / HELLO Santa Barbara. Earlier this year, Jushi acquired GSG SBCA, Inc., a licensed cannabis dispensary in Santa Barbara, and concurrently signed a $3.2M sale-leaseback agreement with a financing partner related to the real estate previously purchased in connection with the acquisition of GSG SBCA, Inc.
NDSN

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08:53 EDT Nordson director Puma sells over $366K in shares - Nordson director Mary Puma sold 1,848 shares of company stock on October 6 for $198.12 per share for a total transaction of $366,126.
CBRL

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08:53 EDT Cracker Barrel shareholder Biglari Capital issues letter to shareholders - Cracker Barrel shareholder Biglari Capital issued a letter to shareholders stating, among other things: "As significant owners of Cracker Barrel Old Country Store, we have nominated Raymond Barbrick, an experienced restaurant executive, to represent all shareholders on the company's board of directors. (...) My aim in this letter is to present you with the facts underlying Cracker Barrel's strategy and the reasons why adding an independent, unaffiliated board member would be beneficial to enhancing the value of your shares. (...) We fully support enhancing the core base of existing Cracker Barrel stores. In our view, enhancing the core - that is, improving store-level performance - represents the greatest lever to augment value. (....) The Board should focus on such value-creating strategies rather than on distracting concepts that bear no resemblance to Cracker Barrel. (...) We question the expansion of the footprint because we do not have the data necessary to assess its validity. (...) Where we have our greatest concern is with the third strategic priority, which morphed over the years to include "new concepts and acquisitions." (...) These "new concepts and acquisitions" are unproven businesses that are both unrelated to the brand and financially burdensome under the umbrella of the corporation. (...) Why Raymond Barbrick should replace Norman Johnson (...) By the Company's own admission, Mr. Johnson possesses neither financial nor restaurant industry experience. Thus, his main contribution has been in the form of "acquisition and growth strategies." (...) By contrast, our nominee, Raymond Barbrick, has over 30 years of restaurant experience in casual dining chains and quick-service restaurants. (....) After the dismal outcomes of chancy, unrelated acquisitions and start-ups, we believe shareholders would benefit from being represented on the Board by an individual with an extensive restaurant background. (....)"
VSLR RUN

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08:51 EDT Sunrun completes acquisition of Vivint Solar - In a regulatory filing, Vivint Solar (VSLR) disclosed that on October 8, 2020, Sunrun (RUN) completed the acquisition of Vivint Solar pursuant to their merger agreement, pursuant to which merger sub merged with and into Vivint Solar, with Vivint Solar continuing as the surviving corporation. As a result of the merger, Vivint Solar became a direct wholly owned subsidiary of Sunrun. In connection with the completion of the merger, on October 8 Vivint Solar notified the New York Stock Exchange that the transaction had closed and requested that the NYSE suspend trading of the Vivint Solar common stock on the NYSE, withdraw the Vivint Solar common stock from listing on the NYSE and file with the SEC a notification on Form 25 to delist the Vivint Solar common stock from the NYSE. As a result, the Vivint Solar common stock will no longer be listed on the NYSE.
PAE

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08:43 EDT PAE selected by Navajo Nation as joint logistics, medical integrator - PAE was chosen by the Navajo Nation to serve as the joint logistics and medical integrator for the Navajo Department of Health's COVID-19 response, to apply proven turnkey solutions operating multiple Alternate Care Sites and deploying mobile testing teams. The award is valued at $50M. In conjunction with Navajo Nation virus response efforts, PAE will employ multiple approaches within a broad strategy to manage the spread of COVID-19. PAE will provide comprehensive ACS facility services and medical staffing 24-hours-a-day at multiple locations, including the Chinle Community Center in Chinle, Arizona. To facilitate wider COVID-19 testing coverage, PAE will deploy mobile testing teams throughout the territory. Support also includes establishing facilities to anticipate future pandemic responses.
RUN

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08:42 EDT Sunrun completes acquisition of Vivint Solar - Sunrun has completed its acquisition of Vivint Solar which was initially announced on July 6, 2020. This follows approval by regulators and stockholders of both companies. With the transaction complete, Sunrun solidifies its position as the leader in home solar and energy services across the United States and a top owner of solar assets globally with more than three gigawatts of solar energy and more than 500,000 customers. Sunrun will be a meaningful contributor to a fully renewable and electrified energy system. Our growing fleet of solar homes and batteries will be networked to provide greater benefits to the grid and energy consumers. Generating energy at the point it is used reduces the need for dirty energy being produced far away that is increasingly expensive to transmit. Our customers have already and will continue to help shut down inefficient carbon-producing power plants. Over the coming months, product offerings will be transitioned to offer customers the best solutions, including expanded access to Sunrun's leading Brightbox rechargeable battery solution which enables homeowners to power through grid outages. Vivint Solar will continue to operate as a Sunrun company for the immediate future and will be integrated into the Sunrun organization over the coming quarters. Sunrun estimates annual cost synergies of approximately $90M to be realized over 12 to 18 months. As previously announced, Vivint Solar stockholders will receive 0.55 shares of Sunrun common stock for each share of Vivint Solar common stock they own immediately prior to the consummation of the acquisition. The combined company will continue to trade on The Nasdaq Global Select Market under the ticker symbol RUN. Post-closing, Sunrun now has a market capitalization of approximately $17B based on the closing prices of Sunrun common stock on October 7, 2020 and an enterprise value of approximately $22B on a fully-diluted basis pro-forma for the transaction as of the most recently reported quarter.
FLDM

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08:41 EDT Fluidigm to offer Advanta COVID-19 tests at low cost to colleges, universities - Fluidigm Corporation announced a program to expand availability of Fluidigm COVID-19 tests for U.S. colleges and universities. The Fluidigm COVID-19 Campus Safeguard Program will provide millions of noninvasive, saliva-based tests for the SARS-CoV-2 virus to qualifying institutions at a cost as low as $5 per test. The Advanta Dx SARS-CoV-2 RT-PCR Assay on the high-throughput Fluidigm Biomark HD system features an integrated testing platform and a reliable supply chain and can be easily combined with commonly available automation platforms. Fluidigm has received Emergency Use Authorization from the U.S. Food and Drug Administration for the Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARSCoV2 virus. The assay does not require collection via invasive nasopharyngeal swab. The company's submission to the FDA demonstrated 100 percent agreement between saliva results from the Advanta Dx SARS-CoV-2 RT-PCR Assay and results from paired nasopharyngeal samples tested with authorized assays. Development, commercialization and implementation of the Advanta Dx SARS-CoV-2 RT-PCR Assay are supported by a $34M definitive contract with the National Institutes of Health under the agency's Rapid Acceleration of Diagnostics initiative. The RADx initiative fast-tracks development and commercialization of innovative technologies to significantly increase U.S. testing capacity for SARS-CoV-2. With the scale-up support, the low-cost, saliva-based Advanta Assay will be targeted to all universities and colleges across the United States. Many higher education systems are struggling to deploy affordable testing programs to serve large populations. Fluidigm has a large number of Biomark HD placements in academic clinical laboratories in the United States that meet requirements to perform high-complexity tests in significant numbers.
VSLR

Hot Stocks

08:40 EDT Vivint Solar trading halted, news dissemination
HJLI

Hot Stocks

08:39 EDT Hancock Jaffe Laboratories engages Syntactx to assist with VenoValve trial - Hancock Jaffe Laboratories announced that it has engaged Syntactx to assist Hancock Jaffe with the VenoValve U.S. pivotal trial. Syntactx will work with Hancock Jaffe in several key areas including strategy, clinical operations, regulatory affairs and safety, as the company prepares for, seeks approval, and conducts the U.S. pivotal trial for the VenoValve. HJLI is currently preparing a pre-IDE submission for the FDA and expects to meet with the FDA in the late Q4 or early Q1 of 2021 to discuss several issues related to the VenoValve U.S. pivotal trial. The company expects to file an IDE application seeking approval from the FDA for the U.S. pivotal trial in Q1 of 2021. Syntactx will assist HJLI with its submissions and interactions with the FDA.
EXLS

Hot Stocks

08:38 EDT AMA Insurance, EXL announce strategic relationship for LifePro deployment - EXL announced that AMA Insurance has selected EXL LifePRO to provide leading edge new business and policy administration platform services. The cloud-based deployment will be hosted by EXL along with ongoing application management support.
AMGN CYTK

Hot Stocks

08:37 EDT Amgen, Cytokinetics, Servier: GALACTIC-HF trial met primary composite endpoint - Amgen (AMGN), Cytokinetics, Incorporated (CYTK) and Servier announced topline results from GALACTIC-HF, a Phase 3 pivotal clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction. The results of GALACTIC-HF show that treatment with omecamtiv mecarbil achieved the primary composite efficacy endpoint and demonstrated a statistically significant effect to reduce cardiovascular death or heart failure events compared to placebo in patients treated with standard of care. No reduction in the secondary endpoint of CV death was observed. Adverse events, including major ischemic cardiac events, were balanced between treatment arms. Additional analyses of data are underway and results from GALACTIC-HF will be presented at the American Heart Association Scientific Sessions 2020, in a virtual Late Breaking Clinical Trial session on Friday, November 13, 2020 from 10:35-10.45 a.m. CDT. Omecamtiv mecarbil is an investigational cardiac myosin activator, the first of a novel class of myotropes1 designed to directly target the contractile mechanisms of the heart.
PHUN

Hot Stocks

08:36 EDT Phunware announces MaaS contract extension by U.S. real estate company - Phunware announced a Multiscreen-as-a-Service, MaaS, contract extension by one of the largest, privately held real estate companies in the United States for its Smart Shopper Solution to enhance their retail shopping experience on mobile. The Customer specializes in shopping, entertainment and residential developments, while also developing parks, plazas integrated with retail environments and mixed-use developments that feature a blend of shopping, dining and entertainment alongside residential living. "Real estate companies, real estate investment trusts and retailers are great partners for Phunware because there is a growing trend in favor of mixed-use development blending business, retail and residential living in pedestrian-friendly environments," said Randall Crowder, COO of Phunware. "These types of complex user experiences demand the kind of tech-enabled mobile engagement that our MaaS platform was specifically designed to achieve, and it's increasingly clear that the COVID-19 pandemic has greatly accelerated adoption curves for digital transformation on mobile as businesses of all types look to foster Healthy Spaces for their customers to work, live and shop again."
AMGN CYTK

Hot Stocks

08:35 EDT Amgen, Cytokinetics, Servier announce results from GALACTIC-HF Phase 3 trial - Amgen (AMGN), Cytokinetics (CYTK), and Servier announced topline results from GALACTIC-HF, a Phase 3 pivotal clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction. The results of GALACTIC-HF show that treatment with omecamtiv mecarbil achieved the primary composite efficacy endpoint and demonstrated a statistically significant effect to reduce cardiovascular death or heart failure events compared to placebo in patients treated with standard of care. No reduction in the secondary endpoint of CV death was observed. Adverse events, including major ischemic cardiac events, were balanced between treatment arms. Additional analyses of data are underway and results from GALACTIC-HF will be presented at the American Heart Association Scientific Sessions 2020, in a virtual Late Breaking Clinical Trial session on Friday, November 13, 2020 from 10:35-10.45 a.m. CDT.
AYI

Hot Stocks

08:34 EDT Acuity Brands CEO expects weakness in nonresidential building activity - CEO Neil Ashe commented, "We continued to demonstrate the durability of our business and our ability to generate cash despite challenging market conditions. We believe the uncertainty around the economic recovery due to the COVID-19 pandemic remains and, as a result, we expect weakness in nonresidential building activity based on current construction indicators. As we look forward to fiscal 2021, we see an opportunity to leverage our expanded product portfolio in lighting, lighting controls, and intelligent buildings along with our investment in our digital transformation to expand market share."
ITI

Hot Stocks

08:34 EDT Iteris awarded $6.9M operational services contract - Iteris announced that the Metropolitan Transportation Commission, or MTC, has awarded Iteris a $6.9M contract to provide operational services for two operations centers in the San Francisco Bay Area. Under the terms of the three-year agreement, which includes an option to extend for an additional four years, Iteris will provide staffing and management services to the 511 Operations Center in Oakland, California that is responsible for collecting, curating and disseminating traffic and transit information for the nine-county Bay Area region. The 511 Operations Center staff disseminate transportation information through the 511 SF Bay traveler information system, of which the 511 Phone System and Transit Data System have been managed by Iteris since 2015. In addition, Iteris will also provide staffing and management services to the Regional Operations Center in San Francisco, California to monitor traffic and toll collection systems along the MTC-operated Express Lanes, and help maximize mobility through congestion management and coordinated incident response.
LXU

Hot Stocks

08:33 EDT LSB Industries announces new 7 year nitric acid contract - LSB Industries announced that it has signed a new long term nitric acid supply contract with a customer. Under the agreement, LSB will supply between 70,000 to 100,000 tons of nitric acid per year. Sales are expected to begin in the first quarter of 2021. "We are very pleased to have been chosen as key long-term supplier of nitric acid to an important customer," stated Mark Behrman, LSB's President and Chief Executive Officer. "Notably, his contract advances one of our key operating initiatives to leverage our underutilized nitric acid production capacity at our El Dorado facility. This contract, along with the previously released CO2 and LDAN agreements, is the result of our focused marketing efforts to sell our excess production capacity and change product mix in order to enhance our margins. We expect these agreements, when combined with the impact of a new fertilizer storage facility that we completed construction on in April, will provide a meaningful increase in incremental annual EBITDA when fully implemented."
AMGN CYTK

Hot Stocks

08:33 EDT Amgen, Cytokinetics Servier announce results from GALACTIC-HF Phase 3 trial - Amgen (AMGN), Cytokinetics (CYTK) and Servier announced topline results from GALACTIC-HF, a Phase 3 pivotal clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction. The results of GALACTIC-HF show that treatment with omecamtiv mecarbil achieved the primary composite efficacy endpoint and demonstrated a statistically significant effect to reduce cardiovascular death or heart failure events compared to placebo in patients treated with standard of care. No reduction in the secondary endpoint of CV death was observed. Adverse events, including major ischemic cardiac events, were balanced between treatment arms. Additional analyses of data are underway and results from GALACTIC-HF will be presented at the American Heart Association Scientific Sessions 2020, in a virtual Late Breaking Clinical Trial session on Friday, November 13, 2020 from 10:35-10.45 a.m. CDT.
LAZY

Hot Stocks

08:31 EDT Lazydays acquiring Camp-Land - Lazydays has signed a letter of intent to acquire Camp-Land, located in Burns Harbor, Indiana. Camp-Land RV is an RV dealership with RV brands including Grand Design, Jayco, Coachmen, Thor and Winnebago. The acquisition of Camp-Land RV is expected to be finalized within 45 days.
ONEXF

Hot Stocks

08:27 EDT Onex to make approx. $960M majority investment in OneDigital - Onex Corporation announced it has agreed to make a majority investment in OneDigital. New Mountain Capital, the former majority shareholder, and OneDigital employees will roll a significant portion of their existing investments into the transaction. Founded in 2000, OneDigital is headquartered in Atlanta, Georgia and has more than 2,000 employees in over 100 offices across the United States. The transaction values OneDigital at $2.65B. The new equity investment of approximately $960M will be made by the Onex Group, including Onex Partners V. Upon closing, the Onex Group and employees of OneDigital will own approximately 83% of the company. The transaction is anticipated to close by the end of 2020 subject to customary conditions and regulatory approvals.
BKYI

Hot Stocks

08:25 EDT U.S. GSA deploys BIO-key's PortalGuard IAM solution - BIO-key International announced that the U.S. Government Services Agency selected BIO-key's PortalGuard IAM solution to deliver flexible, secure and compliant two-factor authentication for a public facing central communication application.
RWBYF

Hot Stocks

08:22 EDT Red White & Bloom Brands' Platinum Vape to expand into Arizona - Red White & Bloom Brands announced that Platinum Vape has entered into agreements with a third-party licensed MSO to launch Platinum products in Arizona later this quarter. PV has entered into a services agreement and sublease with a leading MSO in the State of Arizona. Under these agreements, PV has subleased a licensed facility that encompasses approximately 6,000 square feet of space and expects to see PV branded products in the Arizona market this quarter.
OCX

Hot Stocks

08:21 EDT OncoCyte, Fondazione Michelangelo enter immune therapy biomarker collaboration - Oncocyte Corporation announced a strategic collaboration with the Fondazione Michelangelo in Milan, Italy to evaluate DetermaIO as a biomarker for response in the NeoTRIPaPDL1 trial. The biomarker trial is a prospectively designed, retrospective study of archived study material from the therapeutic trial in triple-negative breast cancer, one of the new frontiers for immune therapy treatment. At recently held scientific conferences, The Society for Immunotherapy of Cancer Annual Meeting 2019 and American Society of Clinical Oncology Annual Meeting 2020, researchers from the West Clinic and MD Anderson Cancer Center, respectively, presented results on the predictive performance of DetermaIO in response to PD-1 therapies in advanced non-small cell lung cancer and TNBC. In these initial studies, the test outperformed the two currently available biomarkers, PD-L1 and TMB, most commonly used to inform patient selection for immunotherapy.
ATIF

Hot Stocks

08:19 EDT ATIF Holdings awarded additional film ads contracts of $1M - ATIF Holdings announced that its majority-owned subsidiary, Leaping Group Co. recently has been awarded additional film advertisement contracts with multiple well-known brands such as Audi, Honda, Construction Bank of China, IKEA, etc. for cinema screen advertising during the prime time of National Day's Golden week holiday. The contracts with the domestic and international companies including Hongqi, Bank of Communications, Country Garden, Poly, Audi, Honda, Construction Bank of China and IKEA are valued at an aggregate amount of $1M. Based on the contracts, LGC will provide advertisement services for the brands in its four theaters in Shenyang City and multiple theaters of Wanda Film in North East China. Wanda Film is one of the top film companies in China and LGC serves as its exclusive agency in the region of Northeast China.
CSCO

Hot Stocks

08:18 EDT Cisco, Qwilt, Digital Alpha collaborate for open caching solution - Cisco, Qwilt and Digital Alpha announced how they are disrupting the commercial Content Delivery Network market with a new as-a-service offering based on Open Caching, with BT as the flagship customer. Open Caching, an open architecture developed and endorsed by the Streaming Video Alliance, offers a platform that federates content delivery infrastructure deployed deep inside service provider networks, into a global CDN with open APIs for content publishers. It is designed to help service providers easily deploy an edge CDN footprint, offering them more control over content flows. It also caters to the needs of global and regional content providers for more capacity, consistency in content delivery and performance assurance. Featuring Digital Alpha as the investing partner providing a unique funding solution, this partnership combines Qwilt's innovative content delivery platform based on Open Caching, with Cisco's edge compute and networking infrastructure to deliver the solution as-a-service to service providers of all sizes around the world.
BNGO

Hot Stocks

08:16 EDT Bionano Genomics announces publication on Bionano's Saphyr - Bionano Genomics announced that its Saphyr system played a key role in a research study by Marcin Imielinski, M.D., Ph.D., Assistant Professor of Pathology and Laboratory Medicine at Weill Cornell Medical School, which was published in the peer-reviewed journal Cell. The study identified three new distinct classes of structural variations in the DNA of thousands of cancer samples across multiple cancer types, and used Saphyr to characterize the precise structure and genomic location of these variations. These previously unknown types of complex rearrangements help explain different mechanisms that enable cancer cells to expand and grow rapidly while simultaneously evading natural defense mechanisms and treatment. With the addition of Bionano's Saphyr data, the study demonstrated that these structural variants generate a large number of fusion proteins and represent therapeutic targets and/or prognostic biomarkers of disease progression. While cancer genomes traditionally have been studied with a combination of low-resolution cytogenetic methods or with next-generation sequencing, Bionano's Saphyr instrument provides long-range data that enables a high-resolution, long-range view into the cancer genome and cancer biology. At a presentation providing an update on the study given at the March 31, 2020 Advances in Genome Biology and Technology Conference, Dr. Imielinski explained how short-read data alone is unable to resolve the structure of these newly discovered structural variants because short reads provide a very local view of the genome, and further explained how integrating long-range data generated by Bionano's optical mapping technology was essential to obtaining a complete understanding of these structures, including their biological significance. As previously announced, a high-profile paper published last month by UCSD Professor Vineet Bafna in Nature Communications similarly used a combination of NGS and Bionano's Saphyr data to resolve the structure of extra-chromosomal circular DNA, another type of complex rearrangement of the cancer genome which similarly allows for tumor cells to increase their growth rate while evading natural defenses. In both studies, only the combination of short-read sequencing technology with optical mapping data generated by Saphyr was able to fully resolve these complex structures and provide a comprehensive picture of the cancer genome.
AMRX

Hot Stocks

08:16 EDT Amneal, PL Developments ship store brand equivalent Voltaren Arthritis Pain Gel - Amneal Pharmaceuticals and PL Developments, PLD, announced that they have commenced shipments of store brand equivalent Voltaren Arthritis Pain Gel, diclofenac sodium topical gel, 1%, in 50, 100 and 150g laminate tubes following FDA clearance. Amneal and PLD have partnered to bring this important product to US retailers.Voltaren Arthritis Pain was switched OTC in February of 2020, making it available to US consumers without a prescription. prior to switching OTC, sales of diclofenac sodium topical gel, 1% totaled approximately $250M. We, along with our partners at PLD, are excited to announce the launch of the first brand matching portfolio of store brand Voltaren OTC," said Chirag and Chintu Patel, Co-Chief Executive Officers. "We were the first to market generic Voltaren Gel in 2016 and are pleased to launch an OTC version. This represents another example of Amneal's commitment to bringing affordable generic medicines to US consumers."
CVX PSX

Hot Stocks

08:16 EDT Chevron Phillips Chemical completes first scale production of polyethylene - Chevron Phillips Chemical, equally owned indirectly by Chevron (CVX) and Phillips 66 (PSX), announced success in its first commercial scale production of polyethylene using advanced recycling technology. Advanced recycling, sometimes referred to as "chemical recycling," converts plastic waste to valuable liquids that can become new petrochemicals. This approach complements traditional recycling by converting a range of materials, including many difficult-to-recycle plastics, into important building blocks for new chemicals. Because of the potential to repeatedly recycle post-use plastics into new materials, polymers produced through advanced recycling are often referred to as "circular polymers." Chevron Phillips Chemical's circular polyethylene matches the performance and safety specifications of the virgin polymers Chevron Phillips Chemical is known for globally. Commercial scale production is a result of the company's two-year exploration into the technical viability of creating circular polymers from waste plastics. Chevron Phillips Chemical is now working on scaling up its production of circular polyethylene to meet its ambitious production plans. That includes working with several proven suppliers of pyrolysis oil, the feedstock made from waste plastics, and pursuing certification for the new polyethylene through the International Sustainability and Carbon Certification Plus approach using their mass balance certification methodology.
NIO CRNC

Hot Stocks

08:15 EDT NIO Inc. selects Cerence for collaboration on voice technologies - Cerence (CRNC) announced that NIO (NIO) has selected Cerence for collaboration to deploy voice technologies in its products.
XENE NBIX

Hot Stocks

08:13 EDT Xenon, Neurocrine: FDA requests further non-clinical data for NBI-921352 study - Neurocrine Biosciences (NBIX) and Xenon Pharmaceuticals (XENE) provided an update on the ongoing collaboration for the clinical development of NBI-921352, previously known as XEN901. Neurocrine Biosciences has an exclusive license to NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy syndrome a rare pediatric epilepsy, and other forms of epilepsy, including focal epilepsy. The U.S. Food and Drug Administration provided feedback on an Investigational New Drug application submitted by Neurocrine Biosciences in support of a Phase II clinical trial in pediatric SCN8A-DEE patients. As part of its review of the IND, the FDA is requesting additional non-clinical data to support dose justification in this pediatric study. Neurocrine Biosciences and Xenon will engage with the FDA to address the feedback received with the goal of initiating a Phase II clinical trial in 2021. In parallel with this interaction, Neurocrine Biosciences is advancing clinical plans to develop NBI-921352 for the treatment of adult focal epilepsy. In addition, the FDA recently granted Rare Pediatric Disease Designation for NBI-921352 for the treatment of SCN8A-DEE. Pursuant to the Collaboration Agreement, upon FDA acceptance of an IND for NBI-921352 in either SCN8A-DEE or another major indication, Xenon is eligible to receive a milestone payment of either $25M or $10M, respectively, with 55% of the amount in the form of an equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.
OZK

Hot Stocks

08:11 EDT Bank OZK reports resignation of Chief Credit Officer of the bank - In a regulatory filing, Bank OZK disclosed that on October 5, John Carter notified Bank OZK of his decision to resign as Chief Credit Officer of the bank to pursue an opportunity with a real estate development and construction company. "To ensure a smooth transition of his duties, Mr. Carter has agreed to continue to serve as the Bank's Chief Credit Officer until October 29, 2020, the effective date of his resignation. Effective October 29, 2020, Tim Hicks, the Bank's Chief Administrative Officer and Executive Director of Investor Relations, will assume the role of Chief Credit Officer in addition to his current duties... Mr. Carter's resignation was not a result of any disagreement with the Bank or any matter relating to its operations, policies or procedures. The Bank appreciates Mr. Carter's hard work and dedication throughout his 11 years of service to the Bank and wishes him success in his new endeavor," the filing added.
SCPH

Hot Stocks

08:11 EDT scPharmaceuticals provides business update for Furoscix befor PDUFA date - scPharmaceuticals provided a business update on FUROSCIX, its investigational proprietary formulation of furosemide for subcutaneous administration. "As we look forward to our upcoming December 30 PDUFA date for FUROSCIX, we are building out what we believe is a world-class commercial team capable of executing a successful product launch, if approved," stated John Tucker, president and chief executive officer of scPharmaceuticals. "In addition, our three posters at this year's Heart Failure Society of America virtual meeting contributed to the growing body of evidence suggesting that FUROSCIX has the potential to be a cost-effective treatment for congestion in patients with heart failure outside the hospital. This is a significant unmet medical need highlighted by Drs. Bensimhon and Desai during our recent Key Opinion Leader webinar. We believe FUROSCIX can help to address this need." To prepare for the launch of FUROSCIX, if approved, the Company has made key additions to its commercial team, including vice presidents of marketing, sales and market access. In addition, recruitment for the Company's field sales team is ongoing and remains closely aligned with currently anticipated regulatory timelines. The Company has submitted twelve-month drug stability data to the U.S. Food and Drug Administration (FDA). Pursuant to an agreement with the FDA, scPharmaceuticals was permitted to submit its New Drug Application (NDA) with nine months of drug stability data and submit the remining three months during the FDA's review. All drug stability data has now been submitted.
XFOR

Hot Stocks

08:10 EDT X4 Pharmaceuticals granted Fast Track Designation for mavorixafor - X4 Pharmaceuticals announced that the U.S. Food and Drug Administration has granted Fast Track Designation to its lead asset, mavorixafor, for the treatment of adult patients with WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor is a potential first-in-class, once-daily, oral, small molecule antagonist of chemokine receptor CXCR4, currently being investigated in a global pivotal Phase 3 clinical trial, 4WHIM, for the treatment of WHIM syndrome. In addition to Fast Track Designation, mavorixafor was previously granted Breakthrough Therapy Designation by the FDA, as well as Orphan Drug status by the FDA and the European Commission for the treatment of WHIM syndrome.
WBA

Hot Stocks

08:10 EDT Walgreens Boots Alliance launches Find Rx Coverage Advisor - Walgreens has launched Find Rx Coverage Advisor, a new resource providing guidance to customers seeking information on available health and prescription drug coverage options. With Medicare Part D and individual marketplace open enrollment approaching, Find Rx Coverage Advisor connects eligible customers directly to health plan partners who can assist with questions about enrollment. Customers can access a personalized report from Find Rx Coverage Advisor by answering a few questions to identify health coverage options. Results include available health plans in their area, including Medicaid, marketplace health plans, Medicare Advantage and Medicare Part D plans, as well as additional prescription savings resources based on the information provided. In the next month, reports can be emailed to customers for additional research or follow-up needs.
CLBS

Hot Stocks

08:09 EDT Caladrius opens PoC study of CLBS119 in COVID-19-induced lung damage - Caladrius Biosciences announced that it has opened its proof-of-concept study of CLBS119 as a treatment for COVID-19-induced lung damage and begun screening prospective patients for inclusion at NYU Langone Health. This planned 12-patient open-label clinical trial is designed to evaluate the safety and efficacy of a single administration of CLBS119 for the treatment and repair of COVID-19-induced lung damage in adults. The study will target patients who are experiencing hypoxia due to prior infection with SARS-CoV-2 and who require supplemental oxygen.
OCUL

Hot Stocks

08:08 EDT Ocular Therapeutix announces topline Phase 1 Clinical trial results of OTX-CSI - Ocular Therapeutix announced topline Phase 1 clinical trial results of OTX-CSI, cyclosporine intracanalicular insert, for the treatment of dry eye disease, DED. "The results of the Phase 1 clinical trial provide an early look at the safety, tolerability, durability, and potential biological activity of OTX-CSI," said Michael Goldstein, MD, MBA, Chief Medical Officer. "While the study enrolled a small number of subjects and was open-label, the results seen thus far are very encouraging. Our novel intracanalicular insert delivered a consistent dose of cyclosporine without preservatives over approximately 12 weeks, in a manner we believe to be both less irritating to the ocular surface and also faster acting than current standard of care eye drop therapies. We believe that if approved by the FDA, OTX-CSI has the potential to become a highly differentiated treatment that would provide significant benefit to patients with dry eye disease and allow them a hands-free alternative to current therapies."
AER

Hot Stocks

08:07 EDT AerCap reports financing transactions for $2.2B in Q3 - AerCap Holdings reported its Q3 major business transactions: signed financing transactions for approximately $2.2B, signed lease agreements for 28 aircraft, including 3 widebody aircraft and 25 narrowbody aircraft; purchased 9 new aircraft, including 8 Airbus A320neo Family aircraft and 1 Boeing 787-9; executed sale transactions for 7 owned aircraft, including 2 Airbus A320 Family aircraft, 1 Boeing 737NG, 1 Boeing 747, 2 Boeing 767s and 1 Boeing 777-200ER.
BB NOW

Hot Stocks

08:07 EDT BlackBerry partners with ServiceNow - BlackBerry (BB) announced it has partnered with ServiceNow (NOW) to integrate the BlackBerry AtHoc service within the Now platform for rapid crisis communications and IT service management. By integrating BlackBerry AtHoc into the Now Platform workflow stack, IT operations teams can now leverage multiple communications channels in the case of an incident, allowing for more efficient and secure communication. This leads to higher levels of collaboration with the wider business to maintain efficiency, productivity and profitability.
CRBP

Hot Stocks

08:06 EDT Corbus to reduce workforce by 54%, extend cash runway to mid-2022 - Corbus Pharmaceuticals Holdings announced a restructuring of its workforce designed to reallocate capital to certain clinical and preclinical programs. Corbus will allocate resources towards its lenabasum clinical development program in dermatomyositis and systemic lupus erythematosus, and our pipeline of other novel ECS-targeting drug candidates. The pipeline includes cannabinoid receptor type 1 inverse agonists, follow-on cannabinoid receptor type 2 agonists, as well as other programs with their own unique mechanism of action in the ECS field. The Company is allocating resources and implementing cost reductions designed with the objective of extending its cash runway to mid-2022. Corbus recorded cash and cash equivalents of approximately $83M at September 30, 2020. The Company intends to reduce ongoing expenses and extend its existing cash runway through the following restructuring initiatives and to prioritize its pipeline: Implementing a restructuring program which will result in a reduction of its workforce by 54%; Focusing on those tasks on the critical path for lenabasum in DM and SLE; and Prioritizing its preclinical pipeline based on what the Company believes is its most promising candidates.
SGEN

Hot Stocks

08:05 EDT Seattle Genetics changes corporate name to Seagen - Seagen is the new corporate name for Seattle Genetics. The company said the evolution of the corporate name reflects the transformation of Seagen as it expands operations globally to bring its marketed medicines to more patients, pursues new indications for approved medicines and continues to advance its pipeline of novel therapies for solid tumors and blood-related cancers. The company's common stock will continue to trade under its current ticker symbol.
CSOD

Hot Stocks

08:05 EDT Cornerstone OnDemand appoints Duane La Bom chief diversity officer - Cornerstone OnDemand announced the appointment of Duane La Bom as the company's first Chief Diversity Officer. In this role, La Bom is responsible for driving the company's diversity, equity and inclusion, DEI, strategy by introducing new programs that foster an inclusive workplace environment and ensure the entire global Cornerstone team is doing its part to contribute to lasting, cultural change. La Bom joins Cornerstone today as a seasoned leader in the DEI space. He brings nearly 20 years of experience leading successful HR and DEI programs at both emerging, high-growth organizations and established Fortune 100 companies. Most recently, he was the Executive Director of Global Diversity & Inclusion for Texas Instruments, and prior to that, he was the Chief Diversity Officer and VP of Talent Management for Andeavor. He also held HR and DEI leadership positions at Rackspace, Toyota Motors Manufacturing North America and Willamette Industries.
MCD

Hot Stocks

08:05 EDT McDonald's reports Q3 U.S. SSS up 4.6% - Monthly comparable sales results improved sequentially for all segments throughout the third quarter of 2020. U.S.: Comparable sales were positive throughout the quarter, benefiting from strong average check growth from larger group orders as well as strong performance at the dinner daypart. The Company's strategic marketing investments and resulting promotional activity drove low double-digit comparable sales for the month of September, including positive comparable sales across all dayparts. Comparable guest counts remained negative for the quarter. International Operated Markets: Comparable sales results improved throughout the quarter, with consumer sentiment and government regulations impacting the pace of recovery from COVID-19. Limited operations also remained in place for some markets. Comparable sales varied across markets with negative comparable sales in France, Spain, Germany and the U.K., partly offset by positive comparable sales in Australia. International Developmental Licensed Markets: Comparable sales results were impacted by negative comparable sales in Latin America and China, partly offset by strong positive comparable sales in Japan.
XENE

Hot Stocks

08:04 EDT Xenon on track to initiate Phase 3 trial with KCNQ2-DEE before year-end - Xenon Pharmaceuticala provided regulatory updates on its proprietary pediatric neurology program, XEN496, a Kv7 potassium channel modulator that is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy. With the U.S. Food and Drug Administration having completed its review of the clinical trial protocol, Xenon is on track to initiate the XEN496 Phase 3 clinical trial in pediatric patients with KCNQ2-DEE before year-end. In addition, Xenon has received a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency, which recommends the granting of an orphan medicinal product designation for XEN496 for the treatment of KCNQ2-DEE. This European designation is in addition to the FDA granting Fast Track designation for XEN496 for the treatment of seizures associated with KCNQ2-DEE as well as Orphan Drug Designation for the treatment of KCNQ2-DEE. The XEN496 Phase 3 "EPIK" clinical trial is titled "A Phase 3 Study of Adjunctive XEN496 in Pediatric Subjects with KCNQ2 Developmental and Epileptic Encephalopathy." This study is designed as a randomized, double-blind, placebo-controlled, parallel group, multicenter clinical trial to evaluate the efficacy, safety and tolerability of XEN496 administered as adjunctive treatment in approximately 40 pediatric patients aged one month to less than 6 years with KCNQ2-DEE. After screening, patients will enter a baseline period to assess the frequency of seizures. Eligible subjects will be randomized on a 1:1 basis to receive either XEN496 or placebo for approximately 15 weeks. At the end of treatment, there will be a period of tapering off of study drug, followed by a 28-day safety monitoring period. Patients may be considered for an open-label extension if they meet all requirements. The primary endpoint is the percent change from baseline in monthly countable motor seizure frequency during the blinded treatment period, as recorded by caregivers in a daily seizure diary. Key secondary endpoints include the proportion of patients experiencing greater than or equal to 50 percent reduction in monthly seizure frequency from baseline, caregiver global impression of change scores, and caregiver global impression of severity scores.
ATIF

Hot Stocks

08:04 EDT ATIF Holdings awarded $1M in additional film ads contracts - ATIF Holdings' majority-owned subsidiary, Leaping Group, a multimedia, advertising and theatre operating firm in Northeast China, has been awarded additional film advertisement contracts with multiple wellbrands such as Audi, Honda, Construction Bank of China, IKEA, etc. for cinema screen advertising during the prime time of National Day's Golden week holiday. The contracts with the domestic and international companies are valued at an aggregate amount of $1M.
BERY

Hot Stocks

08:03 EDT Berry Global is investing in a Reicofil R5 asset to serve Asia market - Berry Global Group announced that it is investing in a state-of-the-art Reicofil R5 asset to provide incremental capacity to serve the fast growing Asia healthcare markets. The investment is targeted to meet forecasted market and customer growth and will be focused on high performance applications in the desired healthcare markets. The nonwovens investment supports Berry's strategy to further its leadership position in healthcare. The new asset will be installed at Berry's Nanhai, China, facility, which is strategically positioned to serve customers in the rapidly growing Southeast Asia region. Current projections are for startup in the September quarter of 2022. "We are committed to further partnering with our customers to pursue growth opportunities around the world. The added capacity achieved through this asset is a next step in advancing our market leading position in healthcare material solutions," said Curt Begle, President of Berry's Health, Hygiene, and Specialties Division. "This investment comes on the heels of the successful commercialization of the first of its kind R5 asset in Berry's Nanhai, China, facility, serving the high-loft soft material needs of the premium hygiene markets throughout the Asia region." Berry will be the first company in the world to secure two state-of-the-art R5 assets. Once installed, the asset will be critical in the manufacturing of healthcare nonwoven materials, primarily surgical drapes and gowns.
AMC

Hot Stocks

08:03 EDT AMC Entertainment to reopen 14 locations in Washington - AMC Entertainment announced that 14 AMC locations in the state of Washington will begin operations on October 16. Washington is the 43rd state out of the 45 U.S. states served by AMC in which AMC will have a theatre that is open for moviegoers. This announcement, along with recent announcements about reopenings in California, Michigan and North Carolina, means AMC will open more than 50 locations in the first three weeks of October. Beginning October 16, AMC expects to have more than 520 of its approximately 600 theatre circuit open and serving guests. In areas where theatres are not yet able to open, AMC continues to have discussions with local authorities about resuming operations. AMC will reopen its remaining theatres once authorized to do so by state and local officials. All reopened AMCs stringently enforce AMC Safe & Clean and follow all local guidelines and directives.
THO

Hot Stocks

08:02 EDT Thor Industries appoints Josef Hjelmaker as Chief Innovation Officer - Thor Industries created a new executive leadership team position of Chief Innovation Officer and has appointed Josef Hjelmaker. Most recently, Hjelmaker led the global cooking product development organization at Whirlpool Corporation.
ETON

Hot Stocks

08:02 EDT Eton announces acceptance of NDA filing for dehydrated alcohol injection - Eton Pharmaceuticals announced the U.S. Food and Drug Administration has accepted for filing the company's new drug application for dehydrated alcohol injection. The application has been assigned a Prescription Drug User Fee Act date of May 27, 2021. Eton's application previously received orphan drug designation for the treatment of methanol poisoning and is expected to receive seven years of market exclusivity upon its approval.
MCD

Hot Stocks

08:01 EDT McDonald's reports Q3 total SSS down 2.2% - Reports Q3 International SSS down 4.4%.
MCD

Hot Stocks

07:59 EDT McDonald's raises quarterly dividend 3% to $1.29 per share - Payable on December 15 to shareholders of record at the close of business on December 1.
MCD

Hot Stocks

07:58 EDT McDonald's reports Q3 SSS up 4.6% in U.S.
CSTL

Hot Stocks

07:54 EDT Castle Biosciences announces expanded Medicare coverage for DecisionDx-Melanoma - Castle Biosciences announced that Medicare Administrative Contractor, Palmetto GBA MolDx, has issued a final expanded local coverage determination, or LCD, for the company's DecisionDx-Melanoma test. The LCD effective date is November 22. Details on the LCD and the billing and coding article are posted to the Medicare Coverage Database on the Centers for Medicare and Medicaid Services, or CMS, website. DecisionDx-Melanoma is a gene expression profile test that uses an individual patient's tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors. The test has been studied in more than 5,700 patient samples.
JNJ

Hot Stocks

07:53 EDT Johnson & Johnson: EC approves Advance Purchase Agreement with Janssen - Johnson & Johnson announced the European Commission, acting on behalf of the European Union Member States, has approved an Advance Purchase Agreement in which the Janssen Pharmaceutical Companies will supply 200M doses of its COVID-19 vaccine candidate to EU Member States following approval or authorization from regulators. The EU Member States also have the option to secure up to 200M additional doses. This contract follows the conclusion of exploratory talks with the EC. The company is in ongoing discussions with other stakeholders, including national governments and global organizations, as part of its efforts to meet its commitment to make its vaccine candidate accessible globally, provided the vaccine has a good safety profile, is efficacious and receives approval or authorization from regulators. Separate to the agreement with the EC, as part of the company's larger commitment to respond to the COVID-19 pandemic, Johnson & Johnson has also announced plans to allocate up to 500M vaccine doses toward international efforts to ensure access for lower income countries, with delivery beginning mid next year following approval or authorization from regulators.
DPZ

Hot Stocks

07:41 EDT Domino's Pizza drops 5% to $410.22 after reporting mixed Q3 results
NUZE

Hot Stocks

07:39 EDT NuZee forms sales advisory team to implement sales strategies - NuZee announced that it has formed an Advisory Team to help develop and implement enhanced sales strategies to fuel growth and to identify potential operational efficiencies. Selected by NuZee's management for their industry knowledge, alignment with the goals of the company, expertise in packaging, B2B sales, production efficiencies, and dedication to coffee, the team members will make themselves available from time to time to make introductions to companies who could benefit by doing business with NuZee.
TAK ARWR

Hot Stocks

07:38 EDT Takeda Pharmaceutical, Arrowhead to co-develop ARO-AAT to treat AATLD - Takeda Pharmaceutical (TAK) and Arrowhead (ARWR) announced a collaboration and licensing agreement to develop ARO-AAT, a Phase 2 investigational RNA interference, or RNAi, therapy in development to treat alpha-1 antitrypsin-associated liver disease, or AATLD. ARO-AAT is a potential therapy designed to reduce the production of mutant alpha-1 antitrypsin protein, the cause of AATLD progression. Under the terms of the agreement, Takeda and Arrowhead will co-develop ARO-AAT which, if approved, will be co-commercialized in the United States under a 50/50 profit-sharing structure. Outside the U.S., Takeda will lead the global commercialization strategy and receive an exclusive license to commercialize ARO-AAT with Arrowhead eligible to receive tiered royalties of 20%-25% on net sales. Arrowhead will receive an upfront payment of $300M and is eligible to receive potential development, regulatory and commercial milestones up to $740M. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the U.S.
DPZ

Hot Stocks

07:37 EDT Domino's Pizza reports Q3 global retail sales growth, ex-FX, of 14.8%
EQX

Hot Stocks

07:36 EDT Equinox Gold increases Mesquite Gold Mine reserves 28% - Equinox Gold announced that exploration during the first half of 2020 has significantly increased Mineral Reserves and Mineral Resources at the company's Mesquite Gold Mine in California, USA. Proven and Probable Mineral Reserves increased 28% to 658,000 ounces of contained gold net of mining depletion to June 30; measured and Indicated Mineral Resources increased 94% to 837,000 oz of contained gold, exclusive of reserves; inferred Mineral Resources increased 38% to 703,000 oz of contained gold. Ongoing exploration continues to demonstrate growth potential at the Brownie deposit; initial drilling highlights include: 35.1 m at 0.51 g/t gold; 33.5 m at 0.66 g/t gold; 52.6 m at 0.85 g/t gold; and 44.2 m at 0.58 g/t gold. At year-end 2019, the Company had identified approximately 40 million short tons of potentially mineralized material from previous operations that had not been drill tested and the Company initiated a 35,000 m exploration drill program.
BIOX

Hot Stocks

07:36 EDT Bioceres says Argentina approves HB4 Wheat 'event' for growth and consumption - Bioceres Crop Solutions announced that Argentina's Ministry of Agriculture has granted approval of the Company's HB4 Wheat 'event' for growth and consumption. Argentina is Latin America's largest wheat producer and the world's first country to adopt HB4 drought tolerance technology for this staple crop. The country's regulatory clearance follows approval of HB4 Soybean, which has been approved in other major production geographies, including the US and Brazil which, together with Argentina, represent nearly 80% of the world's total soybean acreage. Commercialization of HB4 Wheat in Argentina is contingent upon import approval in Brazil, which purchases just over 85% of its wheat from Argentina. Currently, regulatory processes for HB4 Wheat also continue advancing in the US, Uruguay, Paraguay and Bolivia. Bioceres intends to initiate regulatory processes in Australia and Russia as well as certain countries in Asia and Africa.
HSDT

Hot Stocks

07:36 EDT Helius Medical announces formation of MS Scientific Advisory Board - Helius Medical Technologies announced the formation of a Multiple Sclerosis Scientific Advisory Board. The company said, "The Helius MS Scientific Advisory Board currently consists of nine esteemed researchers, clinicians and medical doctors with a body of work in MS and neurorehabilitation that follows the continuum of MS care. The main purpose of the Helius Medical MS Scientific Advisory Board is to advise the Company on aspects of its commercial, reimbursement and market access strategies related to the use of its novel PoNS technology for the treatment of MS. They will review and discuss the Company's existing clinical data, including its real world evidence, as well as its on-going research opportunities. The MS Scientific Advisory Board's initial goals will also include developing a new foundational scientific message, helping to validate the positive effects of neuromodulation in improved neurorehabilitative care, informing the development of the Company's planned U.S. launch strategy to the MS community following the receipt of clearance and providing guidance on the Company's reimbursement and market access strategies." The nine members of the Helius MS Scientific Advisory Board include: Dr. Deborah Backus, PT, PhD, FACRM, Director, MS Research, Shepherd Center, immediate past president and current Board Member, ACRM; Dr. Francois Bethoux, MD, Director of Rehabilitation Services at the Cleveland Clinic Mellen Center; Dr. Michelle Cameron, MD, PT, MCR, Neurologist, Associate Professor, Multiple Sclerosis Center, Oregon Health & Science University; Dr. Evan T. Cohen, PT, MA, PhD, NCS., Associate Professor, Rehabilitation and Movement Sciences, Rutgers University School of Health Professions; Dr. Nora Fritz, PT, PhD, Assistant Professor, Department of Health Care Sciences and Department of Neurology, Wayne State University School of Medicine; Brian Hutchinson, PT, MSCS, Executive Director, Dignity Health, Multiple Sclerosis Achievement Center; Dr. Stephen Kanter, PT, DPT, ATC, Director of Rehabilitation Services at the International Multiple Sclerosis Management Practice; Dr. Prudence Plummer, PT, PhD, Professor, Department of Physical Therapy in the School of Health and Rehabilitation Sciences at MGH Institute of Health Professions; Dr. Mandy Rohrig, PT, DPT, MSCS, Can Do Multiple Sclerosis.
MS EV

Hot Stocks

07:35 EDT Morgan Stanley to acquire Eaton Vance for $7B in cash, stock transaction - Morgan Stanley (MS) and Eaton Vance (EV) have entered into a definitive agreement under which Morgan Stanley will acquire Eaton Vance for an equity value of approximately $7B. Morgan Stanley Investment Management, or MSIM, will be an asset manager with approximately $1.2T of AUM and over $5B of combined revenues. The company said MSIM and Eaton Vance are highly complementary with limited overlap in investment and distribution capabilities. The combination will also bring Eaton Vance's U.S. retail distribution together with MSIM's international distribution. The combination will position Morgan Stanley to generate financial returns through increased scale, improved distribution, cost savings of $150M and revenue opportunities. By financing the transaction with 50% cash, Morgan Stanley will utilize approximately 100bps of excess capital, and the firm's common equity tier 1 ratio is expected to remain approximately 300bps above the firm's stress capital buffer requirement of 13.2%. The transaction is expected to be breakeven to earnings per share immediately and marginally accretive thereafter, with fully phased-in cost synergies, and add approximately 100bps to return on tangible common equity. Under the terms of the merger agreement, Eaton Vance shareholders will receive $28.25 per share in cash and 0.5833x of Morgan Stanley common stock, representing a total consideration of approximately $56.50 per share. Based on the $56.50 per share, the aggregate consideration paid to holders of Eaton Vance's common stock will consist of approximately 50% cash and 50% Morgan Stanley common stock. The merger agreement also contains an election procedure allowing each Eaton Vance shareholder to seek all cash or all stock, subject to a proration and adjustment mechanism. In addition, Eaton Vance common shareholders will receive a one-time special cash dividend of $4.25 per share to be paid pre-closing by Eaton Vance to Eaton Vance common shareholders from existing balance sheet resources. It is anticipated that the transaction will not be taxable to Eaton Vance shareholders to the extent that they receive Morgan Stanley common stock as consideration. The transaction has been approved by the voting trust that holds all of the voting common stock of Eaton Vance. The acquisition is subject to customary closing conditions, and is expected to close in Q2 of 2021.
SIGA

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07:34 EDT SIGA announces PHAC intent to purchase up to 33,300 courses of oral TPOXX - SIGA Technologies announced that the Public Health Agency of Canada has issued an advanced contract award notice, indicating that the PHAC intends to purchase up to 33,300 courses of oral TPOXX within five years as specified in the ACAN, with 3,700 courses to be delivered by March 31, 2021; a cumulative total of 18,500 courses to be delivered by March 31, 2023; and an additional 14,800 courses to be delivered after March 31, 2023, subject to option exercise. The ACAN is required to remain open for at least 15 days, during which time a potential alternative supplier may submit a competing Statement of Capabilities. This ACAN follows, but is separate and incremental to, the issuance in April, 2020 of a contract by the Canadian Department of National Defence for the delivery of up to 15,325 courses of oral TPOXX. The value of courses to be sold to Canada will be disclosed upon any final award by the Canadian government. In any contract issued by Canada, Meridian Medical Technologies, will be the counterparty to the contract and SIGA will be responsible for the manufacture and delivery of product. SIGA was also previously awarded separate funding by the Canadian authorities to support submission of an application for marketing authorization of oral TPOXX to Health Canada, which is targeted to be submitted by the end of 2020. SIGA anticipates approval in 2021.
SAIC

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07:34 EDT SAIC wins $49.5M U.S. Navy contract for RSN C4ISR upgrades and refurbishment - The U.S. Navy awarded Science Applications International a $49.5M single-award task order to continue to provide the Royal Saudi Naval Forces support services for command, control, communications, computers, and intelligence, surveillance and reconnaissance, C4ISR, upgrade and refurbishment. Work will take place in the Kingdom of Saudi Arabia. Under the cost-plus fixed-fee task order, awarded as part of the SeaPort-NxG contract, SAIC will leverage repeatable solutions such as engineering, design and integration, integrated product support and sustainment capabilities on critical networks. These networks fulfill the Naval Information Warfare Systems Command's requirement for Program Executive Office C4I International Integration Program Office Royal Saudi Naval Forces RSNF, In-Kingdom of Saudi Arabia Support Services. "For more than 40 years, SAIC has supported the Navy's mission to help maintain the Royal Saudi Naval Forces' C4ISR capability modernization, engineering and logistics," said Jim Scanlon, SAIC executive vice president and general manager of the Defense Systems Group. "As a leader in technology integration, SAIC is excited to continue its assistance to the Navy as it continues to build this strategic partnership with the Kingdom of Saudi Arabia."
DPZ

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07:33 EDT Domino's Pizza reports 209 gross new stores, 83 net new stores in Q3 - During the quarter, the company reported 209 gross new stores and 83 net new stores, comprised of 44 net new U.S. stores and 39 net new international stores. The company's net store growth reflects the closure of 126 stores, primarily in India. The number of temporary store closures in certain of the company's international markets declined during the third quarter of 2020. Based on information reported to the company by its master franchisees, the company estimates that as of October 5, 2020, there were fewer than 300 international stores temporarily closed.
JAZZ

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07:33 EDT Jazz Pharmaceuticals reports positive Phase 3 results of Xywav in hypersomnia - Jazz Pharmaceuticals announced positive top-line results from the Phase 3 withdrawal study evaluating the efficacy and safety of an investigational use of Xywav oral solution in adult patients with idiopathic hypersomnia. Patients entering the study had excessive daytime sleepiness typical of the idiopathic hypersomnia population. All patients were treated with Xywav during the open-label titration period and clinically meaningful improvements in the Epworth Sleepiness Scale were observed. Those who were administered Xywav showed clinically meaningful maintenance of efficacy for ESS, PGIc and IHSS, and there were highly statistically significant worsenings in patients administered placebo compared with Xywav. The safety profile in this study was consistent with the known safety profile of Xywav with no new safety signals observed in this population. Jazz will submit the Phase 3 study data for presentation at an upcoming medical meeting and these data will be included in the planned submission of a supplemental New Drug Application to the FDA as early as 1Q21. The FDA granted Fast Track designation to Xywav in September.
DOCRF

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07:32 EDT CloudMD launches CloudMD On Demand telemedicine service - CloudMD Software & Services announced the launch of a new service: CloudMD On Demand, an online, virtual care service for companies, insurers and pharmacies to offer their customers easier, more convenient access to virtual telemedicine. CloudMD On Demand aims to provide turnkey and readily accessible virtual healthcare options to enterprise level partners. Through the offering, CloudMD develops a white-labeled, customizable landing page where individuals can get access to a doctor on demand for non-emergency medical appointments. This offering is especially important for employers, insurance providers and pharmacies, who have been instrumental in the development of this service. In addition, corporations with e-commerce websites can streamline the process for customers to see a doctor online and refill a prescription for pick up at a pharmacy location of their choice, or have it delivered directly to their doorstep.
DPZ

Hot Stocks

07:31 EDT Domino's Pizza reports Q3 U.S. same store sales growth of 17.5% - Reports Q3 International same store sales growth of 6.2%; Global net store growth of 83.
IMV

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07:16 EDT IMV Inc. provides update on COVID-19 vaccine program - IMV Inc. provided updates on its vaccine candidate, DPX-COVID-19, for the prevention of infection caused by the novel coronavirus SARS-COV-2. IMV received notification from the Government of Canada indicating that it had reviewed IMV's proposal and its DPX-COVID-19 vaccine candidate had met the required scientific and technical thresholds for funding. As part of the Government of Canada's continuing support for the development of domestic COVID-19 vaccines, the National Research Council of Canada Industrial Research Assistance Program, or NRC IRAP, is providing advisory services and up to $5.4M in funding to support the continuation of clinical trials for IMV's DPX-COVID-19 vaccine candidate. The total DPX-COVID19 funding secured by IMV from different governmental sources to date is approximately $10M. The current funding secured, and further potential funding are milestone based and dependent on the achievement of certain objectives. In consultation with Health Canada, IMV decided to combine its original Phase 1 and 2 studies into a single trial with the potential to accelerate the clinical development and the timeline of the overall project. In collaboration with its lead investigators for the Phase 1/2 clinical study, the design of this larger study will incorporate the same two-age strata cohorts as originally designed. The Phase 1/2 trial is expected to be initiated before the end of 2020 after the completion of the preclinical safety, GLP toxicology and challenge studies that are required to advance into Phase 1/2 studies. These preclinical studies have been ongoing since mid-August. To increase its current manufacturing capacity, IMV has entered a collaboration with a global manufacturing partner and initiated transfer and scale-up activities of DPX-COVID-19. This collaboration has the potential to bring two additional production sites in India and Europe with capacity to produce several hundred million doses of DPX-COVID-19. In parallel, the Company continues its efforts to secure additional non-dilutive funding and agreements with commercial partners to conduct its clinical trials and publish preclinical study results on the selection of the peptides composing DPX-COVID-19 and the data supporting the Phase 1/2 clinical trial in a peer-reviewed scientific journal which are expected before the end of 2020.
MESA

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07:14 EDT Mesa Air operates first revenue cargo flight for DHL Express - Mesa Air Group operated its first revenue cargo flight for DHL Express from its crew and maintenance base at Cincinnati/Northern Kentucky International Airport. Mesa Airlines is the first regional airline to operate narrow-body aircraft like the Boeing 737. The company is currently completing the introduction of the Boeing 737 into the Mesa aircraft fleet. Under the previously announced agreement, Mesa will operate two Boeing 737-400F aircraft on behalf of DHL for a five-year term. Monday marked the official start of that agreement as Mesa begins operations with its first Boeing 737-400F aircraft. The second aircraft is scheduled to enter service in November.
EYPT

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07:13 EDT EyePoint announces amendment to CRG debt facility - EyePoint Pharmaceuticals announced an amendment to its existing debt facility with CRG Servicing. Under the terms of the amendment, CRG has waived the covenant associated with the Company's net product revenue of DEXYCU and YUTIQ for the twelve-month period ending on December 31, 2020. The parties also agreed to a reduction of the December 31, 2021 net product revenue covenant to $45M from $80M based on the promising recovery and return in customer demand for both products following COVID-19-related closures. There were no other material changes made to the term loan agreement with CRG. The Company drew an initial $35M under the debt facility in February 2019. In April 2019, the Company exercised its option to borrow an additional $15M under the terms of the loan. Prior to the conclusion of the debt facility's five-year term, the Company is required to make interest-only payments. At September 30, 2020 the Company had approximately $28.7M of cash.
JPM

Hot Stocks

07:12 EDT JPMorgan commits $30B to advance racial equity including 'affordable' housing' - JPMorgan Chase announced new long-term commitments to advance racial equity. "The firm will harness its expertise in business, policy and philanthropy and commit an additional $30B over the next five years to provide economic opportunity to underserved communities, especially the Black and Latinx communities. Structural barriers in the U.S. have created profound racial inequalities that have been exacerbated by the COVID-19 pandemic. The existing racial wealth gap puts a strain on families' economic mobility and restricts the U.S. economy. Building on the firm's existing investments, this new commitment will drive an inclusive economic recovery, support employees and break down barriers of systemic racism, added JPM. The firm has made commitments to :Promote and Expand Affordable Housing and Homeownership for Underserved Communities Originate an additional 40,000 home purchase loans for Black and Latinx households. To do this, the firm is committing $8 billion in mortgages. Provide an additional 15,000 loans to small businesses in majority-Black and -Latinx communities. To do this, the firm will deliver $2B in loans. The firm will also provide $2B in philanthropic capital over the next five years to drive an inclusive economic recovery and support Black, Latinx and other underserved communities. This extends and increases the firm's current five-year $1.75B philanthropic commitment made in 2018. It will also include an emphasis on supporting Black- and Latinx-led organizations.
XPO

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07:12 EDT XPO Logistics named official transportation partner for Susan G. Komen walks - XPO Logistics announced that it has been named the official transportation partner for all Susan G. Komen 3-Day fundraising walks in 2021. This marks a significant expansion of XPO's partnership with Susan G. Komen, the world's leading nonprofit breast cancer organization. XPO will donate trucks and drivers to support the events, which have drawn more than 500,000 participants nationwide. The company will also provide storage for the equipment, supplies and merchandise used during the 60-mile walks, and XPO trucks will display the iconic Susan G. Komen Running Ribbon.
AOTVF

Hot Stocks

07:11 EDT Ascot Resources intercepts 1,320 g/t silver at Silver Hill - Ascot Resources announced high-grade silver intercepts at the Silver Hill prospect at the Company's Premier Gold Project. These holes are from drill pad SH-02 at Silver Hill located 260 metres to the northeast of last year's intercepts from SH-01, demonstrating the presence of wide-spread mineralization in the area. Highlights from Silver Hill include: 1,320g/t Ag over 1.00m in hole P20-2211; 154.3g/t Ag over 7.12m in hole P20-2220; 4.31g/t Au over 1.00m in hole P20-2219. The Company completed six drill holes from three pads at Silver Hill in August 2020. This news release summarizes the results from four drill holes (for a total of 1,005m). Assays for the other two holes at Silver Hill and for additional holes from the Day Zone are pending and will be released as soon as they are available. We are experiencing delays at our assay lab caused by end of season crunch and reduced capacity for sample preparation due to Covid-19 procedures.
GDDFF

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07:09 EDT Goodfood Market launches Goodfood WOW same-day delivery service - Goodfood Market announces the launch of Goodfood WOW, its new unlimited same-day grocery delivery service, in the Greater Montreal Area. This new service is scheduled to expand to other major Canadian cities over the next year. Goodfood WOW offers an even more flexible and convenient online grocery experience, allowing members to order any combination of meal kits, groceries, prepared meals, and other products as frequently as needed during the week, with same-day delivery included for all orders over $35 - all for only $9.99 a month.
NX ATKR

Hot Stocks

07:08 EDT Quanex appoints William Waltz to board of directors - Quanex Building Products (NX) announced the appointment of William Waltz to its Board of Directors effective October 7, 2020. Waltz has been the President and CEO of Atkore International Group (ATKR) since 2018.
IO

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07:08 EDT Ion Geophysical completes Phase 1 North Sea multi-client program ahead of time - ION Geophysical announced the initial phase of the company's North Sea 3D multi-client program was acquired safely and ahead of schedule. While the majority of the up to ~11,000 sq km industry-supported survey will be acquired next summer, this initial phase enables the company to complete the entire program by the end of the 2021 season. The Mid North Sea High program covers one of the last underexplored sections of the UK Continental Shelf, and is now an area of industry focus following recent play-opening wells. Since the program launched, additional acreage was awarded over the survey area. Final deliverables will be available in April 2021.
CPSS

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07:08 EDT Auto Experience proposes to buy Consumer Portfolio for $135M in cash - Auto Experience announced it has informed the board of directors of Consumer Portfolio Services of its interest in acquiring the company in an all-cash transaction valued at $135M. An acquisition at that price would nearly double the current value of the Nasdaq-listed company. In an October 7, letter to the company formally conveying an "indication of interest," Auto Experience said it proposes to acquire CPS for approximately $6.18 per share of common stock. CPS shares closed at $3.35 on October 7. In its letter to CPS, Auto Experience said it would add value to the company and its shareholders by re-engineering aspects of CPS's operations, applying proprietary technology and enhanced digital capabilities as the market increasingly shifts online, and employing a combination of existing resources and new leadership steeped in automobile financing and digital commerce. In its letter to the company, Auto Experience asked for a response from the CPS Board by October 30.
NX ATKR

Hot Stocks

07:08 EDT Quanex appoints William Waltz to board of directors - Quanex Building Products (NX) announced the appointment of William Waltz to its Board of Directors effective October 7, 2020. Waltz has been the President and CEP of Atkore International Group (ATKR) since 2018.
SLNCF

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07:06 EDT Silence Therapeutics initiates search for CFO - Silence Therapeutics announces that, following its successful Nasdaq listing in September 2020, it has initiated a search for a CFO based in the United States. Rob Quinn, the current CFO who is based in the United Kingdom, will leave the Company in January 2021 to take up a new position, following an orderly transfer of work. A search for the new U.S. based CFO has commenced and a further announcement will be made in due course.
NTEC MRK

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07:06 EDT Intec Pharma enters new research collaboration agreement with MSD - Intec Pharma (NTEC) has entered into a new research collaboration agreement with MSD, the tradename of Merck (MRK). Details of the agreement are confidential.
ATCX...

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07:05 EDT Atlas Technical Consultants appoints Laura Strunk as CLO, Britni Aucoin as CIO - Atlas Technical Consultants (ATCX) announce Laura Strunk as the new Chief Legal Officer and Britni Aucoin as the new Chief Information Officer. Strunk previously served as Associate General Counsel and Assistant Corporate Secretary at USA Compression (USAC) Partners, LP in Austin. Aucoin, a former Digital Practice & Offering Developer Senior Manager at Accenture (ACN) North America, has worked with clients in Oil & Gas and Food & Beverage industries to develop digital strategies for operational technology and manufacturing.
AXGT

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07:03 EDT Axovant appoints Parag Meswani as CCO - Axovant Gene Therapies announced the appointment of Kristiina Vuori, M.D., Ph.D., to its Board of Directors and the promotion of Parag Meswani, Pharm.D., from SVP, Commercial Strategy & Operations to Chief Commercial Officer, effective October 6, 2020. Vuori is a Professor at the Sanford Burnham Prebys Medical Discovery Institute, where she also serves as President and member of the Board of Directors.
LIVX SSNLF

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07:03 EDT LiveXLive Media adds linear OTT channel to Samsung TV Plus - LiveXLive Media (LIVX) announced that Samsung Electronics (SSNLF) will add the LiveXLive linear streaming channel to Samsung TV Plus, its free Smart TV video service that delivers instant access to 145 channels and growing in news, sports, entertainment and more. Samsung TV Plus is one of the top apps on Samsung Smart TVs and is also available in the Galaxy Store and Google Play for select Galaxy smartphones.
ALTR

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07:02 EDT Altair acquires M-Base Engineering + Software, terms not disclosed - Altair announced the acquisition of M-Base Engineering + Software GmbH, a leading international supplier of material database and material information systems, with a focus on plastics. The acquisition of M-Base will allow Altair to offer the most comprehensive, high-fidelity plastics database available on the market, which will directly connect with Altair's powerful solvers. The company said, "One of the most important decisions in product development is the selection of materials for production. Altair has been investing significantly in the area of material modeling for several years. The acquisition of M-Base is an important additional step to deliver comprehensive material information and infrastructure to predict and optimize product performance through simulation. M-Base's offering covers the complete lifecycle of material data, from testing and test evaluation to computer-aided engineering interfaces, with a focus on plastics. M-Base brings to Altair first-rate plastics material data supplied directly by material producers, deep knowledge in material database technology, and plastics material data preparation from raw data to data consumable by designers and engineers. M-Base is the official software supplier to Computer Aided Material Preselection by Uniform Standards, the world's most successful plastic material database adhering to rigorous international standards. Altair will continue to invest in CAMPUS to ensure consistent, high-quality material data for customers to drive accurate simulation results."
TGT

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07:01 EDT Target announces exclusive collection with FAO Schwarz - Target announces an exclusive collection with FAO Schwarz, alongside the largest Bullseye's Top Toys list ever. Whether shopping in store or on Target.com, guests can enjoy more than 600 exclusives and incredible value all season long. And in the season of giving, Target will donate up to $1M as it continues its partnership with Toys for Tots. Later this month, Target and FAO Schwarz's exclusive 70-piece toy collection will be available at Target stores nationwide, on Target.com and at the FAO Schwarz store in New York City, with many items under $20. Known for over 150 years as the most famous toy store in the world, the famed FAO Schwarz store in New York City also will carry more than 300 Target items from the retailer's exclusive brands, including kid-favorites Cat & Jack and Pillowfort.
DG

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06:59 EDT Dollar General launches new retail store format Popshelf - Dollar General launched its newest retail store concept popshelf. This new store aims to engage customers with seasonal and home decor, health and beauty, home cleaning supplies, party goods and more with approximately 95% of items priced at $5 or less. Customers can visit these stores when the first two popshelf locations open near Nashville, Tennessee this fall. popshelf plans to debut its first two locations near Nashville, Tennessee in the Hendersonville and Clarksville communities with current plans to have approximately 30 locations in various markets by the end of fiscal year 2021. Initial targeted customers are primarily female and are located in diverse suburban communities with a total household annual income ranging from $50K to $125K.
CARR AMZN

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06:57 EDT Carrier Global, AWS collaborate to co-develop Lynx digital platform - Amazon Web Services, an Amazon.com company (AMZN), and Carrier Global (CARR), announced a multi-year agreement to co-develop Carrier's new Lynx digital platform. This suite of tools will provide Carrier customers around the world with enhanced visibility, increased connectivity, and actionable intelligence across their cold chain operations to improve outcomes for temperature-sensitive cargo, including food, medicine, and vaccines. The collaboration builds on Carrier's selection of AWS as its preferred cloud services provider in February, 2020.
BKE

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06:54 EDT The Buckle reports September net sales up 22.7% year-over-year - The Buckle reported comparable store net sales, for stores open at least one year, for the 5-week period ended October 3 increased 22.9% from comparable store net sales for the 5-week period ended October 5, 2019. Net sales for the 5-week fiscal month ended October 3 increased 22.7% to $94.9M from net sales of $77.3M for the prior year 5-week fiscal month ended October 5, 2019. Comparable store net sales year-to-date for the 35-week period ended October 3, 2020 decreased 9.6% from comparable store net sales for the 35-week period ended October 5, 2019. Net sales for the 35-week fiscal period ended October 3, 2020 decreased 9.9% to $504.4M from net sales of $559.6M for the prior year 35-week fiscal period ended October 5, 2019.
MRNA

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06:53 EDT Moderna awarded $56M from DARPA - Moderna announced an agreement for a commitment of up to $56M from the Defense Advanced Research Projects Agency to fund development of a mobile manufacturing protype leveraging Moderna's existing manufacturing technology that is capable of rapidly producing vaccines and therapeutics. The agreement builds on a previous assistance grant with DARPA established in 2013.
TPX

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06:52 EDT Tempur Sealy enters new joint venture to reposition Sealy products in the UK - Tempur Sealy announced that it is reacquiring the rights and acquiring the assets to manufacture, market and distribute Sealy and Stearns & Foster branded products in the United Kingdom from its current licensee. The company has entered into a new 50/50 joint venture to develop, expand and reposition Sealy products in one of the largest bedding markets in Europe. Sealy United Kingdom is a 50/50 joint venture between the company and its Asian joint venture partners. The joint venture in Asia has established Sealy in its markets as a premium brand with innerspring products and strong retailer relations. Over the last 20 years, the Sealy Asian joint venture has grown net sales at an annual compounded growth rate of approximately 36%, opened seven new manufacturing facilities and increased consideration for Sealy branded products across the Asia-Pacific region. Tempur Sealy chairman and CEO Scott Thompson stated, "We identified that the premium innerspring segment in the United Kingdom market is not being fully served. We believe we have brought together the right people, brands and strategy to satisfy the market's needs. Sealy is the number one brand in the United States, and we believe this transaction will significantly improve our competitive position in the United Kingdom for generations to come. I would also like to acknowledge the Silentnight Group for their strong management of the Sealy brand in the United Kingdom over the last 47 years and thank our joint venture partners, the Dyer Family, for working with us on this new growth opportunity."
HELE

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06:52 EDT Helen of Troy CEO Julien Mininberg to continue through February 29, 2024 - Helen of Troy CEO Julien R. Mininberg intends to extend his employment with the company through February 29, 2024. The company and Mininberg are working to finalize an amended employment agreement. CFO Brian Grass intends to retire to pursue entrepreneurial interests and will step down from his position effective November 1, 2021, after more than 15 years at the company and more than seven years in the CFO role.
MRNA MRK

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06:52 EDT Moderna regains all rights to RSV vaccine mRNA-1172 from Merck - Moderna (MRNA) announced that it has regained all rights to the respiratory syncytial virus vaccine (mRNA-1172) from Merck (MRK), including rights to develop RSV vaccines for adult populations. mRNA-1172, which uses a Merck lipid nanoparticle for delivery, entered Phase 1 development in 2019. Under the terms of the agreement, Merck will complete the Phase 1 study and transition the program to Moderna. Moderna has now consolidated all global commercial rights to all development candidates in its core prophylactic vaccines modality. Among its RSV candidates, Merck decided to focus its efforts on RSV infections through its antibody program that is currently in Phase 2 development. Separately, Moderna also announced the initiation of dosing in the Phase 1 study of its solely owned RSV vaccine candidate (mRNA-1345). This Phase 1 study includes initial dosing in adults, followed by age de-escalation into children. The company previously announced its intent to advance mRNA-1345 in children in combination with mRNA-1653, a vaccine against two other pediatric respiratory viruses which is currently in its own age de-escalation study. With today's announcement, Moderna will have the right to also advance RSV vaccines in adults, either alone or in combination with other respiratory virus vaccines. Moderna's mRNA-1345 vaccine uses the Company's proprietary lipid nanoparticle delivery technology also used in the company's COVID-19 vaccine (mRNA-1273) and CMV vaccine (mRNA-1647). Moderna and Merck will continue their ongoing collaboration in cancer vaccines. In 2016, Moderna and Merck entered into a collaboration for mRNA-4157, a personalized cancer vaccine candidate, which is currently being evaluated in a Phase 2 study. In 2018, the companies expanded the collaboration to include the development and commercialization of mRNA-5671 a mutant KRAS vaccine candidate currently in a Phase 1 study.
LLY...

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06:50 EDT Eli Lilly arranges for potential COVID-19 therapy supply to low-income countries - Eli Lilly (LLY) and the Bill & Melinda Gates Foundation, as part of the COVID-19 Therapeutics Accelerator, have entered into an agreement to facilitate access to future Lilly therapeutic antibodies under development for the prevention and treatment of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus, to benefit low- and middle-income countries. Therapeutic antibodies have the potential to prevent and treat COVID-19, reducing the burden on healthcare systems worldwide. This effort to bring equitable access to novel treatments is part of the COVID-19 Therapeutics Accelerator, an initiative launched by the Gates Foundation, Wellcome, and Mastercard (MA) to speed the development of and access to therapies for COVID-19. Commercial manufacturing will commence in April 2021 at the Fujifilm (FUKIY) Diosynth Biotechnologies facility in Denmark, where the Therapeutics Accelerator reserved manufacturing capacity in an agreement announced in April. The Gates Foundation based its decision to collaborate with Lilly for the manufacturing capacity on pre-set criteria, including available information regarding safety, efficacy and ability to implement in lower-resource settings. Lilly has already started the manufacturing technology transfer at risk, in anticipation of regulatory authorization for its antibody therapy. In the interest of making supply of COVID-19 therapeutic innovations available globally as quickly as possible, Lilly will make certain volumes of its antibody therapeutic manufactured in other facilities available to lower-income countries prior to April 2021, pending the timing of regulatory authorization. Lilly and its collaboration partners will continue to be responsible for research and development of the product. Lilly's collaborators, AbCellera Biologics, Shanghai Junshi Biosciences and Columbia University have agreed to waive their royalties on the Lilly therapeutic antibodies distributed in low- and middle-income countries as part of this initiative.
MRK

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06:49 EDT Merck announces week 96 data from the Phase 2b trial (NCT03272347) - Merck announced Week 96 data from the Phase 2b trial (NCT03272347) evaluating the efficacy and safety of islatravir, the company's investigational oral nucleoside reverse transcriptase translocation inhibitor, in combination with doravirine, in treatment-naive adults with HIV-1 infection. Week 96 findings demonstrated that the combination of islatravir and doravirine maintained virologic suppression, and the findings were consistent with Week 48 results. Additional Week 96 data from the study show low rates of participants meeting the definition of protocol-defined virologic failure in both the islatravir plus doravirine and the DELSTRIGO treatment arms, and no participants in either arm met the criteria for resistance testing. Merck also announced results from Phase 1/1b studies for MK-8507, the company's investigational once-weekly oral non-nucleoside reverse transcriptase inhibitor, which showed that the antiviral potency and pharmacokinetics of MK-8507 support further investigation for once-weekly oral administration as part of combination antiretroviral therapy. These analyses were presented as oral and poster presentations at the virtual 2020 International Congress on Drug Therapy in HIV Infection.
PFE OPK

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06:47 EDT Pfizer, Opko Health: C0311002 Phase 3 study met primary endpoint - Pfizer (PFE) and OPKO Health (OPK) announced that C0311002, a Phase 3, randomized, multicenter, open-label, crossover study evaluating somatrogon dosed once-weekly in children 3 to less than18 years of age with growth hormone deficiency, met its primary endpoint of improved treatment burden compared to GENOTROPIN for injection administered once-daily. Top-line results from the study demonstrated that treatment with somatrogon once-weekly improved the mean overall Life Interference total score after 12 weeks of treatment (8.63) compared to treatment with somatropin administered once-daily (24.13). The point estimate of the treatment difference was -15.49 in favor of somatrogon at the nominal 0.05 level. In addition, key secondary endpoints showed an overall benefit in treatment experience with the somatrogon once-weekly dosing regimen compared to the somatropin once-daily dosing regimen.
CDXC

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06:38 EDT ChromaDex's licensed nicotinamide riboside shows anti-cancer function in study - ChromaDex highlighted a new study from Nature Immunology that found nicotinamide riboside helped energize tumor infiltrating T-cells in samples extracted from mice. ChromaDex is the exclusive licensee of Dr. Charles Brenner's patented NR. In a preclinical mouse model, NR was shown to improve T-cell function, which is a component of new cancer immunotherapies such as PD-1 and PDL-1 inhibitors. These findings lend further data to the potential role of NR in supporting healthy mitochondrial function. T-cells are immune cells tasked with recognizing and eliminating infected, damaged or cancerous cells. The researchers found that NR was shown to improve responsiveness to anti-PD-1 cancer immunotherapy. The tumor bearing mice fed with NR experienced less tumor growth, and an additive antitumor effect was observed when NR was combined with immunotherapy. This latest study from Nature Immunology indicates a new potential niche for NR supplementation by suggesting a synergistic effect with T-cell immunotherapies used for many solid tumors. More research is required to validate this preclinical data and translate the findings into humans. Over 50 human trials investigating NR's various health benefits are registered on ClinicalTrials.gov.
IBM

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06:37 EDT IBM to execute spin-off of Managed Infrastructure Services unit - IBM announced it will accelerate its hybrid cloud growth strategy. Additionally, IBM will separate its Managed Infrastructure Services unit of its Global Technology Services division into a new public company. The separation is expected to be achieved as a tax-free spin-off to IBM shareholders, and completed by the end of 2021. IBM will focus on its open hybrid cloud platform. With tighter integration and focus on its open hybrid cloud and AI solutions, IBM will move from a company with more than half of its revenues in services to one with a majority in cloud software and solutions. IBM will also have more than 50% of its portfolio in recurring revenues. As part of this strategic acceleration, IBM is taking action to simplify and optimize its operating model for speed and growth. This includes streamlining its geographic model and transforming its go-to-market structure. IBM is also continuing to consolidate its shared services. The company said this operating model will support accelerated innovation for the hybrid cloud, and provide more flexibility to increase investment in growth areas. The new company has relationships with more than 4,600 technology-intensive clients in 115 countries, including more than 75% of the Fortune 100 and a backlog of $60B. The new company will be entirely focused on managing and modernizing client-owned infrastructures. It will leverage its expertise to offer hosting and network services, services management, infrastructure modernization, and migrating and managing multi-cloud environments. With a streamlined business model, the new company will help enterprises optimize their performance through AI and automation. NewCo will also be able to partner fully across all cloud vendors, while maintaining a strong strategic partnership with IBM and continuing to serve existing and new clients. The proposed separation is expected to be effected through a pro-rata spin-off to IBM shareowners that will be tax-free for U.S. federal income tax purposes. The transaction is subject to customary closing conditions, including Form 10 registration with the U.S. Securities and Exchange Commission, receipt of a tax opinion from counsel, and final approval by IBM's board. The separation is currently expected to be completed by the end of 2021. Following separation, the companies together are initially expected to pay a combined quarterly dividend that is no less than IBM's pre-spin dividend per share. Following the completion of the separation, each company's dividend policy will be determined by its respective board. One-time transaction costs are expected to include tax charges, operational separation activities, and other customary items.
BW

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06:31 EDT Babcock & Wilcox unit awarded $2M contract - Babcock & Wilcox announced that its B&W Environmental segment will design and supply its highly efficient SPIG S.p.A. cooling towers for a pulp mill operated by LD Celulose S.A. in the Triangulo Mineiro region in Brazil. The contract is valued at approximately $2M. LD Celulose S.A. is a joint venture between the Austria-based Lenzing Group and the Brazil-based Duratex. The plant will produce 500,000 tons of soluble cellulose annually
EVTCY BMY

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06:25 EDT Evotec receives $6M payment from Bristol-Myers following portfolio expansion - Evotec (EVTCY) announced that the company has received a $6M payment from Bristol-Myers (BMY) following the decision to expand the portfolio by another drug discovery project. Evotec and Bristol-Myers initiated the collaboration in 2016 to identify disease-modifying treatments for a broad range of neurodegenerative diseases. Currently approved drugs only offer short-term management of patients' symptoms and there is a huge unmet medical need for therapies that slow down or reverse disease progression in the field of neurodegenerative diseases. This collaboration pursues an approach to the discovery and development of novel medicines by leveraging several of Evotec's technology platforms in conjunction with the human iPSC-based platform. The partnership between Bristol-Myers and Evotec has already found several access points into neurodegenerative diseases. Adding yet another approach with direct relevance to Alzheimer's disease further complements the portfolio, which currently covers a range of incurable neurodegenerative conditions.
TSM

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06:24 EDT TSMC reports September revenue NT$127.59B, up 24.9% y/y - TSMC announced its net revenues for September 2020: On a consolidated basis, revenues for September 2020 were approximately NT$127.59B, an increase of 3.8% from August 2020 and an increase of 24.9% from September 2019. Revenues for January through September 2020 totaled NT$977.72B, an increase of 29.9% compared to the same period in 2019.
FB

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06:21 EDT Facebook to suspend U.S. political ads after polls close on Election Day - Facebook will suspend indefinitely all political and social-issue advertising in the U.S. after the polls close November 3. "While ads are an important way to express voice, we plan to temporarily stop running all social issue, electoral or political ads in the US after the polls close on November 3, to reduce opportunities for confusion or abuse. We will notify advertisers when this policy is lifted," the company said. Facebook also said it would add restrictions to posts about poll-watching operations that use militarized language or suggest an aim to intimidate voters. Reference Link
SPI

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06:18 EDT SPI Energy regains compliance with Nasdaq - SPI Energy announced that it received a letter from the Listing Qualifications Department of Nasdaq, indicating that for the ten consecutive trading days from September 23 to October 6, the company's market value of publicly held shares, or MVPHS, had been $15M or greater as required for continued listing on Nasdaq. Accordingly, the company has regained compliance with such requirement, and the matter is now closed.
KR

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06:06 EDT Kroger launches two on-premise ghost kitchens at stores in Indiana, Ohio - Kroger announced the launch of two on-premise kitchens, respectively at stores in Metro Indianapolis, Indiana and Metro Columbus, Ohio. Developed in partnership with ClusterTruck, a technology start-up that operates delivery-only restaurants, the kitchens will provide a variety of freshly prepared meals on-demand with no service or delivery fees. Kroger and ClusterTruck's on-premise kitchens were developed from the momentum and insights of a pilot launched in December 2019 in Carmel and Indianapolis, Indiana and Columbus, Ohio. Different from the off-premise concept, the new concept will repurpose approximately 1,000 square feet at each participating store to create a culinary space for ClusterTruck staff to prepare meals for quick delivery and in-store pickup. Customers can order from a menu of more than 80 meals, spanning a variety of ingredients. The expansion of Kroger's relationship with ClusterTruck reflects the retailer's ongoing investments in providing a variety of prepared fresh food options and creating an experience for customers. Kroger experienced a 127% digital sales lift in Q2, as customers continued to use digital ordering options, including pickup, delivery and ship to home.
AFIN

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06:03 EDT American Finance Trust provides Q3 rent update - American Finance Trust announced that 91% of the original cash rent due for Q3 has been received as of October 2, including 96% of the original cash rent due in the company's single-tenant portfolio. "Once again, we are reporting excellent rent collection for the third quarter," said Michael Weil, CEO of AFIN. "Our collection rate continued to improve across our portfolio as compared to our second quarter results. The continued strength of our single tenant portfolio is evident with 96% rent collection in addition to a 14% increase in rent collected in the multi-tenant portfolio as compared to the second quarter as rent deferral agreements end and tenants resume paying full rent. With 91% of the original cash rent received, we believe our success on this front is largely due to the high-quality and resiliency of our necessity retail focused portfolio, which is primarily leased to investment grade or implied investment grade tenants including 80%1 of our top ten tenants in the portfolio."
GILD

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05:30 EDT Gilead, European Commission sign JPA to enable access to Veklury in the EU - Gilead and the European Commission signed a joint procurement agreement, or JPA, that will enable access to Veklury, the first antiviral drug proven to be effective for the treatment of COVID-19 in the European Union, or EU. The JPA enables participating countries in the EU and the European Economic Area, or EEA, and the UK to purchase Veklury for both real-time demand and stockpiling needs, coordinated by the European Commission. The agreement covers purchases of Veklury over the next six months and has the option to be extended. In the EU, EEA and UK, Veklury is indicated for the treatment of COVID-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen. The JPA replaces an emergency support instrument, or ESI, that enabled the European Commission to procure Veklury for EU Member States, including the UK, from August through October. Both the ESI and JPA temporarily remove the need for country-by-country reimbursement processes that typically follow marketing authorization, in recognition of the current health crisis. Gilead will begin fulfilling orders the week of October 12. The European Commission granted conditional marketing authorization of Veklury on July 3, based on data from the randomized, double-blind, placebo-controlled ACTT-1 trial that demonstrated the clinical efficacy and safety of Veklury in COVID-19 patients with pneumonia requiring supplemental oxygen. The filing was also supported by data from two randomized clinical trials demonstrating the efficacy and safety of Veklury in five-day and ten-day dosing durations. The increased supply of Veklury will expand access to the medicine to additional appropriate patients with COVID-19, offering the potential for patients to recover faster, thereby reducing hospital stays and healthcare resource utilization. Supply of Veklury is expected to meet global demand by the end of this month, enabling the purchase of Veklury both to treat patients and to support national stockpiling of the medicine for current and future surges of COVID-19. The significant increase in Veklury supply is the result of early investments that Gilead made to increase internal manufacturing capacity, expand external contract manufacturing network and shorten the production timeline through process improvements. More than 40 contract manufacturing organizations, including more than 10 partner sites in Europe, support the production of Veklury supply for patients and clinical trials around the world. Through these efforts, Gilead is on track to produce more than 2M treatment courses of Veklury this year, increasing supply by more than 400-fold since January and will produce several million more treatment courses in 2021, if required.
INFY

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05:26 EDT Infosys to acquire Blue Acorn iCi - Infosys announced a definitive agreement to acquire Blue Acorn iCi. Blue Acorn iCi is a digital customer experience company. It brings to Infosys cross-technology capabilities through the convergence of customer experience, digital commerce, analytics, and experience driven commerce services. With services that include strategy, analytics, design, and engineering, Blue Acorn iCi elevates marquee global brands across industries from media, consumer goods & retail, to financial services, manufacturing and technology. Together with Infosys' earlier acquisition of Wongdoody that offers creative and marketing services, BlueAcorn iCi brings capabilities to help global CMOs and businesses in a digital commerce world. The acquisition is expected to close during Q3 of FY21, subject to customary closing conditions.
WMT

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05:20 EDT Sam's Club to hire 2,000 associates for holiday shopping season - Sam's Club, owned by Walmart, is adding more days of deals, introducing more newness, more often in clubs and online. And, as Sam's Club gears up for a busy shopping season, it is hiring 2,000 supply chain associates to support the expected demand. Additionally, Sam's will unveil all its November deals in a single savings book, mailed to members' homes the week of October 21. The deals for the December events will also be shared with members in just one book that is mailed to members' homes in late November. Sam's Club is hiring 2,000 permanent, full-time associates across the country for its supply chain operations in both its fulfillment centers and distribution centers. All fulfillment center hourly associates will receive a $2 hourly premium during the holiday season. Hundreds of those new hires will work at the retailer's new fulfillment center in Perris, California, just outside of Los Angeles, which opened last month. This will be the first holiday season that club associates will fulfill online orders. The program, called Ship from Club, will utilize more than 100 clubs across the country to pick online orders from club inventory and ship directly to members' homes. Ship from Club is expected to speed up the fulfillment of orders and account for about one-fifth of all online orders. Also new this year, members will be able to shop online and pick up at their club in all 597 locations. Launched earlier this year, curbside pickup is the latest contactless shopping offer from Sam's Club. As always, Sam's Club members can use its Scan & Go technology for a contactless experience when shopping in clubs.
DNB

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05:14 EDT Dun & Bradstreet to acquire Bisnode for approximately $818M - Dun & Bradstreet announced that it has entered into a definitive agreement to purchase the outstanding shares of Bisnode, a European data and analytics firm and long-standing member of the Dun & Bradstreet worldwide network. The estimated purchase price upon closing is 7.2B SEK or approximately $818M. The transaction is expected to close in January 2021, subject to required regulatory approvals and customary closing conditions. The acquisition positions Dun & Bradstreet to expand across Scandinavia, Germany, Austria, Switzerland and central Europe. Upon transaction close, Dun & Bradstreet will add over 110,000 Bisnode customers to its client base, ranging from small businesses to large enterprises, including having direct access to nearly 50 Global 500 companies headquartered in Bisnode territories. The deal provides direct access to Bisnode's 33M records from over 550 sources throughout Europe, contributing to the scale, depth, diversity and accuracy of the company's constantly expanding Data Cloud that contains information on more than 360M total businesses. Upon transaction close, the company plans to introduce its modern finance & risk and sales & marketing solutions at scale to clients across Europe. The company said the Dun & Bradstreet and Bisnode teams are well-positioned to realize operational efficiencies and hit the ground running upon transaction close. Upon the close of the transaction and to further support its growth agenda, Dun & Bradstreet will establish an International Strategic Advisory Board which will be led by Sahai with inclusion of Jonas Wistrom, CEO for Ratos. Upon the close of the transaction, it is expected that 75% of the consideration would be paid in cash and 25% of the consideration would be paid in newly issued shares of common stock of the company in a private placement.
AVAV SFTBY

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05:07 EDT AeroVironment completes Sunglider HAPS stratospheric test flight - AeroVironment (AVAV) announced the Sunglider solar-powered high-altitude pseudo-satellite, or HAPS reached an altitude of more than 60,000 feet above sea level and demonstrated mobile broadband communication. Sunglider's development and testing is funded by HAPSMobile, a joint venture majority-owned by SoftBank (SFTBY) and minority-owned by AeroVironment. During the test flight, which began at 5:16 a.m. MDT on September 21 and concluded at 1:32 a.m. MDT on September 22, the AeroVironment team piloted Sunglider to a stratospheric altitude of 62,500 feet above Spaceport America in New Mexico. Sunglider achieved test objectives relating to propulsion, power systems, flight control, navigation and datalink integrity, as well as structural performance during the most turbulent phases of the flight as it entered and exited the jet stream. The broadband communication demonstration linked teams in Tokyo, Spaceport America and Silicon Valley using an LTE payload jointly developed by Alphabet's Loon LLC and HAPSMobile. Employing standard LTE smartphones, a team at Spaceport America conducted multiple video calls via the Sunglider's payload while the aircraft circled for more than five hours in the stratosphere. The Sunglider, a solar-powered HAPS, has a wingspan of 262 feet and is propelled by 10 electric motors powered by solar panels covering the surface of the wing and rechargeable battery packs, resulting in zero emissions. Flying at an altitude of approximately 65,000 feet above sea level and above the clouds, the Sunglider can carry payloads weighing as much as 150 pounds and is designed for continuous, extended missions of months without landing.