Stockwinners Market Radar for December 13, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

PS

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21:54 EST Pluralsight to be acquired by Vista for $20.26 per share in cash or $3.5B - Pluralsight announced that it has entered into a definitive agreement to be acquired by Vista Equity Partners. Under the terms of the agreement, Vista, in partnership with its institutional co-investors including Partners Group, will acquire all outstanding shares of Pluralsight common stock for $20.26 per share in an all-cash transaction valued at approximately $3.5B. The purchase price represents a premium of approximately 25% to the company's volume weighted average closing stock price for the 30 trading days prior to today's announcement. The deal has been unanimously approved and recommended by an independent Transaction Committee and then unanimously approved by the Pluralsight board. Pluralsight has also entered into a voting agreement with certain of its shareholders, under which such shareholders have agreed to vote all of their Pluralsight shares in favor of the transaction. The Pluralsight shares subject to the voting agreement represent a majority of the current outstanding voting power of Pluralsight shares. "In response to receipt of unsolicited acquisition interest, Pluralsight engaged in a robust process, including evaluating transaction alternatives against Pluralsight's standalone plan and other strategic alternatives," the company said. The transaction is expected to close in the first half of 2021.
PFE...

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19:54 EST Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. Pfizer (PFE) and BioNTech (BNTX) have announced that the Food and Drug Administration has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. The vaccine is now authorized under an Emergency Use Authorization while Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application with the FDA for a possible full regulatory approval in 2021. Under Operation Warp Speed, the Department of Defense in partnership with agencies within the Department of Health and Human Services, including the U.S. Centers for Disease Control and Prevention, will manage allocation and distribution of the vaccine in the U.S., the companies said in a statement. Following the announcement, FedEx Express, a subsidiary of FedEx (FDX), said that operations are in motion to transport its first shipments of COVID-19 vaccines. Express will begin transport of the vaccine using its FedEx Priority Overnight service supported by FedEx Priority Alert advanced monitoring. Meanwhile, UPS (UPS) also announced its involvement and full support of distribution efforts for Pfizer-BioNTech's COVID-19 vaccine as part of Operation Warp Speed. Pfizer's and BioNTech's vaccine. UPS will move the Pfizer-BioNTech COVID-19 vaccine within the first days to states designated by Pfizer based on orders received by Operation Warp Speed and CDC officials. 2. AstraZeneca (AZN) and Alexion Pharmaceuticals (ALXN) have entered into a definitive agreement for AstraZeneca to acquire Alexion. Alexion shareholders will receive $60 in cash and 2.1243 AstraZeneca American Depositary Shares, or ADSs, with each ADS representing one-half of one ordinary share of AstraZeneca, as evidenced by American Depositary Receipts, or ADRs, for each Alexion share. Based on AstraZeneca's reference average ADR price of $54.14, this implies total consideration to Alexion shareholders of $39B or $175 per share. 3. Electric vehicles are the future of the auto industry, so it's no surprise they have captured Wall Street's imagination, Al Root wrote in this week's edition of Barron's. Xpeng's (XPEV) ADRs have tripled, Li Auto (LI) is up 180% from its July 30 IPO and Nio's (NIO) ADRs are up nearly 600%, the author noted, adding that while It can be hard to part with a stock after such enormous gains, taking profits in the Chinese EV trio looks like the prudent thing to do. High valuations aren't a reason to sell a stock-just ask anyone who bet against Tesla (TSLA), whose shares have soared about 650% this year. But China's EV upstarts face potential risks that don't appear to be factored into their stock prices, Root contended. 4. Gaming company Roblox (RBLX) had been preparing to go public this month but has decided to delay its initial public offering until next year, The New York Times' Kellen Browning reported. Meanwhile, Affirm Holdings (AFRM) is also postponing its initial public offering, The Wall Street Journal's Maureen Farrell and Cara Lombardo report, citing people familiar with the matter. 5. Mercury General's (MCY), Disney (DIS), and Starbucks (SBUX) saw positive mentions in this week's edition of Barron's.
TCRR

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10:37 EST TCR2 announces interim data from ongoing Phase 1 of TC-210 Phase 1/2 trial - TCR2 Therapeutics announced interim data from the ongoing Phase 1 portion of the TC-210 Phase 1/2 clinical trial for mesothelin-expressing solid tumors. As of the November 24, 2020 data cutoff, three PRs according to RECIST 1.1 criteria have been recorded among the first eight patients treated on study, with its first ovarian cancer patient having achieved a confirmed PR up to month six. In addition, the first patient treated at a higher gavo-cel dose without lymphodepletion achieved stable disease through two months without any significant toxicities, which has allowed patients to start treatment at that dose with the addition of lymphodepletion. The toxicity profile remains manageable with only two patients to date exhibiting gavo-cel-related non-hematologic grade greater than 2 toxicity and no evidence of neurotoxicity or on-target, off-tumor toxicity. Translational data further demonstrated TRuC-T cell expansion and cytokine induction in all patients. The primary objectives of the Phase 1 portion of the study are to define the safety profile of gavo-cel in patients whose tumors overexpress mesothelin and to determine the recommended Phase 2 dose. Secondary objectives include ORR and disease control rate. Exploratory objectives include the assessment of expansion, tumor infiltration, and persistence of gavo-cel.
BNTX PFE

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10:27 EST CDC Committee recommends Pfizer, BioNTech COVID vaccine for '16 years and older' - Pfizer (PFE) and BioNTech (BNTX) announced that the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to recommend the use of the Pfizer-BioNTech COVID-19 vaccine in people 16 years of age and older under the Emergency Use Authorization issued by the U.S. Food and Drug Administration. This ACIP vote follows the December 1, 2020, ACIP recommendation for a Phase 1a rollout where first priority of COVID-19 vaccines is given to health care personnel treating patients, and residents in nursing homes and other long-term care facilities. ACIP advises the CDC on the types of populations and circumstances for which vaccines should be used. The advisors based the recommendation on the scientific evidence supporting the COVID-19 vaccine, including data from a Phase 3 clinical study announced last month and published in The New England Journal of Medicine on December 10, 2020, as well as on interim guidance that ACIP made on December 1, 2020 regarding the allocation of initial vaccine doses. The vaccine was authorized by the FDA on December 11, 2020 under an EUA while Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application with the FDA for a possible full regulatory approval in 2021. The first vaccine supplies are being prepared to ship from Pfizer's Kalamazoo, MI site, and will be distributed by the U.S. Department of Defense in partnership with agencies within the Department of Health and Human Services, including the CDC, to government-designated facilities across the country.
REGN NTLA

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10:19 EST Intellia achieves normal human Alpha-1 Antitrypsin protein levels in NHPs - Intellia Therapeutics (NTLA) presented the first demonstration of physiological protein levels of human alpha-1 antitrypsin in non-human primates following a single administration. Compared to traditional adeno-associated virus gene therapy, Intellia's targeted liver gene insertion technology has the ability to achieve therapeutic levels of protein expression, in a stable and durable manner, after a single course of treatment. The company presented these data at the Alpha-1 Foundation's 20th Gordon L. Snider Critical Issues Workshop: The Promise of Gene-Based Interventions of Alpha-1 Antitrypsin Deficiency. Intellia is advancing multiple genome editing strategies that may treat both lung and liver manifestations of AAT deficiency, which occur due to mutations in the SERPINA1 gene. The normal human AAT protein levels Intellia achieved following targeted insertion of the human SERPINA1 gene remained stable through 11 weeks in an ongoing NHP study. The observed levels of human AAT protein produced from the liver may be therapeutically sufficient to restore protease inhibition to protect the lungs and liver from improperly regulated neutrophil elastase activity. The NHP data build on previous results showing that consecutive in vivo genome editing achieved therapeutically relevant results in an AATD mouse model. The findings presented reinforce recent data showing the use of the same proprietary insertion technology for targeted gene insertion of Factor 9 resulted in circulating human Factor IX, a blood-clotting protein that is missing or defective in hemophilia B patients, that ranged from normal levels to supratherapeutic levels in a six-week NHP study. Intellia and Regeneron (REGN), the lead party, are co-developing potential hemophilia A and B CRISPR/Cas9-based treatments using their jointly developed targeted transgene insertion capabilities. Intellia is continuing to develop its proprietary platform to advance its wholly owned research programs, such as AATD.
BNTX...

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10:13 EST UPS to support distribution of approved vaccine as part of Operation Warp Speed - UPS (UPS) announced its involvement and full support of distribution efforts for Pfizer (PFE)-BioNTech's (BNTX) COVID-19 vaccine as part of Operation Warp Speed. Pfizer's and BioNTech's vaccine, approved through a U.S. Food and Drug Administration emergency use authorization, is the first to be deployed in a months-long global race to develop safe vaccines to combat the spread of the COVID-19 virus. UPS will move the Pfizer-BioNTech COVID-19 vaccine within the first days to states designated by Pfizer based on orders received by Operation Warp Speed and CDC officials. "This is the moment of truth we've been waiting for at UPS," says Wes Wheeler, president of UPS Healthcare. "We have spent months strategizing with Operation Warp Speed officials and our healthcare customers on efficient vaccine logistics, and the time has arrived to put the plan into action." Pfizer-BioNTech COVID-19 vaccines will originate from storage sites in Michigan and Wisconsin. The vaccines will be transported to UPS Worldport facilities in Louisville, where they will be expedited Next Day Air to select destinations, including hospitals, clinics and other medical facilities, to inoculate healthcare workers.
BNTX...

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10:10 EST FedEx to ship first wave of COVID-19 vaccines across the U.S. - FedEx Express, a subsidiary of FedEx (FDX), announced that operations are in motion to transport its first shipments of COVID-19 vaccines. Following the Food and Drug Administration's approval of Emergency Use Authorization for the Pfizer (PFE)-BioNTech (BNTX) COVID-19 vaccine, FedEx Express will begin transport of the vaccine using its FedEx Priority Overnight service supported by FedEx Priority Alert advanced monitoring. After months of preparation and close planning with Pfizer, other healthcare companies, and federal and state officials, the first COVID-19 vaccines will move to dosing centers in the United States. Vaccine distribution will be balanced among major cargo carriers, and FedEx is working closely with healthcare customers to prepare for additional vaccine shipments and transportation of critical vaccine-related supplies. "This is among the most important work in the history of our company, and we're honored to be a part of the effort to help end this pandemic," said Raj Subramaniam, president and chief operating officer, FedEx. "I am immensely proud of our dedicated team members who continue to go above and beyond to help ensure the safe movement of these critical COVID-19 vaccines, especially during our busiest holiday shipping season to date. This is who we are and what we do at FedEx."
PFE WBA

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10:06 EST Walgreens issues statement regarding FDA EUA of COVID-19 vaccine - Walgreens Boots Alliance (WBA) said in a statement that, "The announcement from the FDA providing Pfizer [PFE] with emergency use authorization on its COVID-19 vaccine is a historic milestone and important step toward ending the pandemic. We have the opportunity to turn the tide on a pandemic that has wreaked havoc on our lives and livelihoods. Walgreens is preparing to immediately bring vaccines to high-priority populations, as determined by the Centers for Disease Control and federal and state governments. These include long-term care facility residents and staff, as well as healthcare workers. We will be collaborating with nearly 35,000 skilled nursing and assisted living facilities nationwide that have selected Walgreens as their vaccine provider. As states finalize their distribution plans, we believe we can begin administration in some long-term care facilities on the date of activation approved by the CDC to help ensure those most vulnerable are among the first to be protected against the virus. With our nationwide store footprint, extensive vaccine experience and pharmacy team members embedded in communities across the country, we are prepared to expand access to the general population through our more than 9,000 stores once COVID-19 vaccines become available more broadly in 2021. We will continue to work closely with Operation Warp Speed, as well as the CDC, Health and Human Services and federal and state governments to ensure the administration of COVID-19 vaccines across the nation as soon as possible."