Stockwinners Market Radar for November 26, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

15:37 EST Moderna testing existing and new variant-specific vaccine candidates for Omicron - Moderna announced updates to its strategy to address SARS-CoV-2 variants of concern, given the emergence of the B.1.1.529, or "Omicron," variant. "The recently described Omicron variant includes mutations seen in the Delta variant that are believed to increase transmissibility and mutations seen in the Beta and Delta variants that are believed to promote immune escape. The combination of mutations represents a significant potential risk to accelerate the waning of natural and vaccine-induced immunity. A booster dose of an authorized vaccine represents the only currently available strategy for boosting waning immunity. The Moderna COVID-19 vaccine - mRNA-1273 - is authorized as a booster for many populations at the 50 microgram dose level. The Company is working rapidly to test the ability of the current vaccine dose to neutralize the Omicron variant and data is expected in the coming weeks. Since early 2021, Moderna has advanced a comprehensive strategy to anticipate new variants of concern. This strategy includes three levels of response should the currently authorized 50 microgram booster dose of mRNA-1273 prove insufficient to boost waning immunity against the Omicron variant," the company stated. Moderna said it has already tested a higher dose booster of mRNA-1273, 100 microgram, in healthy adults. Moderna has completed dosing of 306 participants in a safety and immunogenicity study of this high dose booster. The 100 microgram dose of mRNA-1273 has also recently been studied by the National Institutes of Health in the U.S. and has generally resulted in the highest neutralizing titers against prior SARS-CoV-2 strains. Moderna is working to rapidly test sera from its high dose booster recipients in neutralizing assays to determine if the 100 microgram dose provides superior neutralizing protection against Omicron. Second, Moderna is already studying two multi-valent booster candidates in the clinic that were designed to anticipate mutations such as those that have emerged in the Omicron variant. The first candidate, mRNA-1273.211, includes several mutations present in the Omicron variant that were also present in the Beta variant of concern. The company has completed dosing in a potentially pivotal safety and immunogenicity study of mRNA-1273.211 at the 50 microgram and 100 microgram dose levels. A second multi-valent candidate, mRNA-1273.213, includes many of the mutations present in the Omicron variant that were also present in the Beta and Delta variants. The company has completed dosing at the 100 microgram dose level and also plans to explore the 50 microgram dose level in approximately 584 participants. Moderna will rapidly expand testing of sera from completed and ongoing multi-valent booster studies to determine if these multi-valent candidates are able to provide superior neutralizing protection against Omicron. Third, Moderna will rapidly advance an Omicron-specific booster candidate, mRNA-1273.529. This candidate is part of the company's strategy to advance variant-specific candidates for a subset of variants of significant concern. During 2021 this has already included Beta- and Delta-specific boosters. The company has repeatedly demonstrated the ability to advance new candidates to clinical testing in 60-90 days. "From the beginning, we have said that as we seek to defeat the pandemic, it is imperative that we are proactive as the virus evolves. The mutations in the Omicron variant are concerning and for several days, we have been moving as fast as possible to execute our strategy to address this variant. We have three lines of defense that we are advancing in parallel: we have already evaluated a higher dose booster of mRNA-1273, second, we are already studying two multi-valent booster candidates in the clinic that were designed to anticipate mutations such as those that have emerged in the Omicron variant and data is expected in the coming weeks, and third, we are rapidly advancing a Omicron-specific booster candidate," said Stephane Bancel, CEO of Moderna.

11:00 EST Pfizer, BioNTech report positive CHMP opinion on vaccine use in children 5 to 12 - Pfizer (PFE) and BioNTech SE (BNTX) yesterday announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency issued a positive opinion on the administration of the companies' COVID-19 vaccine Comirnaty in children 5 to under 12 years of age. "The European Commission will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future. If the EC grants the variation regarding a vaccination in this age group, the decision will be immediately applicable to all 27 EU member states. If approved, Comirnaty will be the first COVID-19 vaccine authorized in the European Union for individuals 5 to under 12 years of age," the companies stated. Reference Link

10:08 EST Biofrontera Inc trading resumes

10:00 EST Direxion Financial Bear 3x rises 11.3% - Direxion Financial Bear 3x is up 11.3%, or $2.07 to $20.39.

10:00 EST Cars.com rises 14.3% - Cars.com is up 14.3%, or $1.90 to $15.21.

09:47 EST Adagio Therapeutics Inc trading resumes

09:37 EST Adagio Therapeutics Inc trading halted, volatility trading pause

09:21 EST Qiagen reaffirms effectiveness of its SARS-CoV-2 PCR tests against new variant - QIAGEN announced its polymerase chain reaction, PCR, tests remain accurate and effective in detecting SARS-CoV-2 infections in light of the emergence of a new variant of concern detected in South Africa. QIAGEN has successfully assessed its SARS-CoV-2 PCR tests against the genetic mutations of the variant, which is known by its scientific name, B.1.1.529. This applies to all of QIAGEN's PCR tests for detection of the SARS-CoV-2 virus involving: artus SARS-CoV-2 Prep&Amp UM Kit, a CE-marked SARS-CoV-2 test that integrates sample preparation and detection in a single kit; QIAstat-Dx syndromic testing system, which includes the CE-marked test QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2; and NeuMoDx 96 and 288 integrated PCR testing systems used in laboratory testing. Furthermore, the new variant is reliably detected by: QIAGEN's QIAcuity digital PCR solution, which uses a SARS-CoV-2 wastewater surveillance assay developed in collaboration with GT Molecular; and QIAGEN's QIAprep& Viral RNA kit, which uses qPCR genotyping assays that are available in collaboration with biomers.net. "The best way to fight the global COVID-19 pandemic is a combination of extensive vaccinations, rigorous testing with gold-standard PCR tests, aggressive surveillance of new variants and above all compassionate treatment for those infected with the SARS-CoV-2 virus," said Dr. Davide Manissero, M.D., Chief Medical Officer of QIAGEN N.V. "We are pleased to report that the emergence of this new variant of concerns, as has been the case with other variants, has had no impact on the effectiveness of our SARS-CoV-2 PCR tests. Further genomic sequencing of SARS-CoV-2 samples worldwide will vastly increase transparency and help us identify and respond to potentially dangerous mutations of the virus, while at the same time broadening the database we can use to verify if vaccines and tests continue to be effective," Manissero said.

09:17 EST FDA posts briefing documents for meeting to discuss EUA for Merck's molnupiravir - The FDA has posted Advisory Committee briefing documents to summarize the data submitted by Merck and Ridgeback Biotherapeutics to support the Emergency Use Authorization of molnupiravir for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death, ahead of the Antimicrobial Drugs Advisory Committee Meeting to be held on November 30. Currently three antivirals monoclonal antibodies, or mAbs, are authorized for the treatment of mild-to-moderate COVID-19 in individuals who are at high risk for progression to severe COVID-19, but these products all require intravenous or subcutaneous injection for administration, noted the FDA. Molnupiravir is an oral prodrug with antiviral activity against SARS-CoV-2. The FDA is asking the Advisory Committee to discuss the available data regarding the known and potential benefits and the known and potential risks of MOV to support the proposed authorized use and is seeking advice from the Committee regarding the population for authorized use. "The Agency's current assessment is that MOV should not be authorized for initiation of treatment in hospitalized patients because benefit of treatment with MOV was not observed in participants already hospitalized due to COVID-19. However, should a patient require hospitalization after starting treatment with MOV, the patient may complete the full 5-day treatment course at the healthcare provider's discretion," the briefing documents state. Additional considerations regarding the patient population for authorized use include, but are not limited to, how "high risk" is defined for progression to severe COVID-19 and whether SARS-CoV-2 vaccination status should be taken into consideration when making a decision about the use of molnupiravir, the FDA said. Reference Link

09:04 EST Ferroglobe idles furnaces as Sabon, Boo, aims to reduce production at Monzon - Ferroglobe announced that the Company has taken incremental actions to counter the impact of rising energy prices in Spain. The Company has decided to idle one furnace at the Sabon facility, a second furnace at the Boo facility, and aims to reduce target production by 25% at the Monzon facility by modulating production in line with volatility in the energy price. Collectively, these actions are aimed at minimizing the impact of rising energy costs in Spain, while enabling us to satisfy our existing obligations to customers. Mr. Marco Levi, Ferroglobe's CEO stated, "During this unprecedented time where energy prices in Spain have more than quadrupled over the past few months, we are constantly seeking ways to minimize the impact. The ability to leverage our broad asset footprint and technical expertise proves to be valuable in countering this problem." Mr. Levi continued, "This latest set of actions enables us to fulfil our customer obligations in Spain, in part by utilizing other assets in the region, with the goal of optimizing each order. We continue to monitor this unique situation on a daily basis and will make operational adjustments accordingly."

08:52 EST Exela announces extension, supportf from over 80% of holders for exchange offer - Exela Technologies announced that it has further extended the early tender time and has extended the expiration time, in each case, from 11:59 p.m., New York City time, on November 24, 2021 until 5:00 p.m., New York City time, on December 1, 2021, with respect to the previously announced exchange offer by certain of its subsidiaries for Old Notes as described in the Offering Memorandum and the Offering Memorandum Supplement No. 1. The Exchange Offer continues in full force and effect, except additional protections will be added to the New Notes for the benefit of investors which are set forth in the Offering Memorandum Supplement No. 2 being distributed on November 26, 2021. As of the Original Tender Time, approximately $430.7 million, or 46.0%, of outstanding Old Notes were validly tendered for exchange pursuant to the Exchange Offer. In addition, certain holders of the Old Notes who collectively hold approximately $350.6 million of outstanding Old Notes have agreed that they would tender for exchange all of their Old Notes. As a result, after taking into account the additional tenders by such Supporting Holders, the Issuers expect that approximately $781.3 million, or 83.5%, of outstanding Old Notes will be tendered pursuant to the Exchange Offer and delivered pursuant to the Consent Solicitation, as applicable, which would allow the Issuers to effectuate the proposed amendments to the indenture governing the Old Notes and the Old Notes to, among others, eliminate substantially all of the restrictive covenants and certain events of default and to release all of the collateral securing the Old Notes. Old Notes validly tendered and not validly withdrawn at or prior to the Extended Tender Time will still be eligible to receive $900 in cash per $1,000 principal amount of the Old Notes, up to the maximum amount of $225 million in cash. As the cash offer is already oversubscribed, Old Notes validly tendered and not validly withdrawn at or prior to the Extended Tender Time will be accepted for cash on a pro rata basis. The remainder of Old Notes validly tendered and not validly withdrawn at or prior to the Extended Tender Time and not accepted for cash will be exchanged into the Issuers' 11.500% First-Priority Senior Secured Notes due 2026 on the basis of $1,000 principal amount of the New Notes for each $1,000 principal amount of outstanding Old Notes. The Company expects settlement for the Exchange Offer to occur promptly after the Extended Tender Time. The deadline to validly withdraw tenders of the Old Notes has passed and has not been extended.

08:17 EST General Electric announces participation upsizing in debt tender offers - GE announces the results as November 24, 2021 for its previously announced offer to purchase for cash, for its own account and on behalf of the Subsidiary Issuers, upon the terms and subject to the conditions set forth in the Offer to Purchase, dated November 10, 2021: up to $7,000,000,000 aggregate principal amount of the Pool One securities; up to $7,950,000,000 aggregate principal amount of the Pool Two securities, previously up to $7.5M; and up to $10,050,000,000 aggregate principal amount of the Pool Three securities, previously up to $8.5M. GE now expects to achieve more than $80B in gross debt reduction between the end of 2018 and the end of 2021. The company said it is, "on track to achieve deleveraging targets and deliver high-single-digit free cash flow margins in today's portfolio of businesses in 2023."

08:09 EST Cabot signs agreement to sell Purification Solutions business for $111M - Cabot Corporation announced that the company entered into an agreement to sell its Purification Solutions business to One Equity Partners, a middle market private equity firm, in a transaction valued at $111M, subject to certain debt-like and other closing adjustments. Cabot's Purification Solutions business researches, develops, manufactures and sells high-performing activated carbon used in a range of environmental, health, safety, and industrial applications. "We are pleased to have reached an agreement with One Equity Partners as they have a proven track record of advancing market-leading industrial companies and are committed to the future success of the business," said Sean Keohane, Cabot president and chief executive officer. "At the same time, this transaction will allow us to focus resources on our core business segments and invest in areas where we see strong future growth and innovation potential for Cabot, such as Battery Materials."

08:06 EST Kratos Defense receives initial production order for jet engines - Kratos Defense & Security Solutions announced that it has recently received an initial production order for a new, affordable, high performance jet engine for an aerial vehicle application from a national security related customer. Kratos is currently under contract from several government and other national security related customers for the development of next generation, affordable, high performance turbojet, turbofan, and other engine types for unmanned aerial system aircraft, cruise missiles, powered munitions, and other related leading technology systems. Work under this new, initial production order will be performed at a secure Kratos manufacturing facility. Due to competitive, customer related, security related, and other reasons, no additional information will be provided related to this recent contract award.

08:04 EST Standard Lithium files preliminary report on South-West Arkansas Lithium Project - Standard Lithium announced it has now filed a Preliminary Economic Assessment Report for the Company's South-West Arkansas Lithium Project, further to its news release dated October 12, 2021. The report is available on www.sedar.com and https://www.standardlithium.com/projects/arkansas-smackover. The Technical Report, entitled "Preliminary Economic Assessment of SW Arkansas Lithium Project" was prepared by independent consulting companies: NORAM, HGA, APEX Geoscience Ltd., ECCI, Matrix Solutions Inc., and METNETH2O Inc. Key Points: Pre-tax $2.83B NPV at 8% discount rate and IRR of 40.5%; After-tax $1.97B NPV at 8% discount rate and IRR of 32.1%; 20-year mine-life producing an average of 30,000 tonnes per year of battery-quality lithium hydroxide monohydrate; Operating costs of $2,599 per tonne of battery quality lithium hydroxide; AACE Class 5 Total CAPEX estimate of $870M including conservative 25% contingency of direct capital costs; and, SW Arkansas Lithium Project PEA lithium brine resource is updated to consider the potential unitized area of production, leading to an increased total in-situ resource of 1,195,000 tonnes Lithium Carbonate Equivalent at the Inferred Category.

08:02 EST Tantech Holdings subsidiary wins $7.8M factoring agreement - Tantech Holdings announced that its subsidiary, First International Commercial Factoring Co., won a major factoring agreement valued at approximately $7.8M. This represents the company's first such agreement since announcing its intention to develop factoring opportunities. Under the agreement, First International will buy approximately $7.8M of outstanding receivables and outstanding invoices at a discounted rate from the customer, which in turn will help improve the customer's cash flow and revenue stability.

07:55 EST COVID vaccine related names gain in pre-market amid new variant scare - Shares of biotech names with COVID-19 vaccine/testing exposure are trading higher in the pre-market following yesterday's World Health Organization warning about a new Covid-19 variant with a large number of mutations in the key spike protein that is reported to be spreading rapidly in South Africa. Among the gainers, Pfizer (PFE) is up 5.6%, BioNTech SE (BNTX), is up 7.4%, Moderna (MRNA) is up 8.8%, Vir Biotechnology (VIR) is up 9.9%, Novavax (NVAX) is up 5.3%, and InflaRx N.V. (IFRX) is up 8.4%.

07:48 EST CP, KSU merger proposal receive Mexican regulatory approvals - Canadian Pacific Railway (CP) and Kansas City Southern (KSU) announced that they have received the required regulatory pre-transaction control approvals from the Mexican Federal Economic Competition Commission, COFECE, and the Mexican Federal Telecommunications Institute, IFT, for the previously announced proposed combination of KCS and CP. "This important milestone marks the next step on our path to creating the first single-line rail network linking the U.S., Mexico and Canada," said Keith Creel, CP President and Chief Executive Officer. "This historic combination will add capacity to the U.S. rail network, create new competitive transportation options, support North American economic growth, and deliver important benefits to customers, employees and the environment."

07:28 EST Crypto names retreat in pre-market trading as bitcoin falls below $54,000 - The price of bitcoin was down sharply overnight, falling below $54,000 - the lowest level since early October. Stocks levered to bitcoin prices are also trading lower in early pre-market trading, with Bit Digital (BTBT) down 6.9%, Riot Blockchain (RIOT) down 7.4%, Marathon Digital (MARA) down 7.5%, and Coinbase Global (COIN) down 3.4%.

07:09 EST Ocugen falls 10% to $6.37 after FDA places clinical hold on vaccine candidate

07:02 EST Ocugen says FDA issues clinical hold on IND application for COVAXIN - Ocugen announced that the U.S. Food and Drug Administration has issued a clinical hold on the Company's Investigational New Drug application to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN outside the United States. The FDA plans to identify the specific deficiencies that are the basis for clinical hold and information on how to address those deficiencies. The Company expects to receive formal written communication with the additional information from the FDA and plans to work with the FDA in an effort to resolve its questions as promptly as possible.

06:50 EST EU commercial vehicle registrations down 16.4% in October - In October, registrations of new commercial vehicles in the EU continued their downward trajectory, posting another double-digit drop of 16.4%, reported the European Automobile Manufacturers Association on Thursday. "All vehicle segments saw declines, but van and bus sales fell most significantly. The region's overall performance was not helped by its largest markets, as all four suffered double-digit losses last month," stated the industry group. Publicly traded truck makers and suppliers include Daimler AG (DDAIF), Paccar (PCAR), CNH Industrial (CNHI), Navistar (NAV), Cummins (CMI) and Allison Transmission (ALSN).

06:47 EST Quotient Technology directors buy about $201K in common stock - In regulatory filings released Wednesday evening, Quotient Technology disclosed that its director Andrew Gessow bought 7K shares of common stock for about $51K and director Robert McDonald bought 20.3K shares for $150K on November 22nd.

06:36 EST Pinduoduo reports Q3 average monthly active users 741.5M, up 15% y/y - Active buyers in the twelve-month period ended September 30 was 867.3M, an increase of 19% from 731.3M in the twelve-month period ended September 30, 2020.

06:15 EST U-Haul Storage of West Jackson facility permanently closes - The U-Haul Storage of West Jackson facility permanently closed its doors on Nov. 1 after 26 years of serving the local community. The facility at 1414 Gibralter Drive opened to DIY moving and self-storage customers in 1995. The property encompassed 29,496 square feet and was a furniture store before U-Haul bought it in 1994. U-Haul provided truck and trailer sharing, self-storage and moving supplies at the store. U-Haul will maintain ownership of the 1.42-acre property. Future plans are undetermined. Five Team Members were let go as a result of the U-Haul Storage of West Jackson closing.

05:56 EST UMC, Micron announce global settlement agreement - United Microelectronics (UMC) and Micron Technology (MU) announced a settlement agreement between the two companies worldwide. The companies will globally withdraw their complaints against the other party, and UMC will make a one-time payment of an undisclosed amount to Micron. UMC and Micron look forward to engaging in mutual business cooperation opportunities.