Stockwinners Market Radar for January 09, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:05 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. Airlines canceled thousands more flights in recent days as the industry tried to move past its holiday hangover, The New York Times' Niraj Chokshi reported. Bad weather and coronavirus outbreaks among workers continued to disrupt schedules across the United States, but airlines have also called off many recent flights, in advance, so they can correct course at a traditionally slow time for travel without surprising customers with last-minute cancellations, the author noted. About 5,000 flights were canceled from Friday through Sunday, according to FlightAware, a data tracking service, with the daily number of cuts declining steadily over that period. Publicly traded companies in the space include Alaska Air (ALK), American Airlines (AAL), Delta Air Lines (DAL), JetBlue (JBLU), Southwest (LUV), Spirit Airlines (SAVE) and United Airlines (UAL). 2. Citigroup (C) staff in the United States who have not been vaccinated against COVID-19 by Jan. 14 will be placed on unpaid leave and fired at the end of the month unless they are granted an exemption, Reuters' David Henry and Noor Zainab Hussain, Anirban Sen reported, citing a company memo. The U.S. bank announced its plan to impose new vaccination rules in October and now becomes the first major Wall Street institution to follow through with a strict vaccine mandate, the authors noted. 3. While Proterra (PTRA) would seem to have a lot going for it, 2021 was a bumpy road for the company, whose stock is down 20% for the past year, Al Root wrote in this week's edition of Barron's. Its big problem is that it merged with a SPAC in mid-June in order to go public, and has seen its share price tumble as investors sold off SPACs at the end of the year, the author noted. This, however, might spell opportunity for investors, he added. 4. Sony (SONY) and Marvel's "Spider-Man: No Way Home" stayed atop the chart with another $33M in its fourth outing, making it one of the top 10-grossing movies of all time at the domestic box office. Globally, "Spider-Man: No Way Home" also made the top 10 to land at number 8 with a total gross of $1.53 billion. 5. Robinhood (HOOD), Coca-Cola (KO), Vertex (VRTX), and MGM (MGM) saw positive mentions in this week's edition of Barron's.

19:25 EST Exact Sciences acquires PreventionGenetics for $190M - Exact Sciences announced it has acquired PreventionGenetics, a genetic testing laboratory, to complement its advanced cancer diagnostics portfolio and support its entrance into hereditary cancer testing. PreventionGenetics provides the clinical lab, expertise, and foundational technology necessary to accelerate the availability of HCT and help more patients know their germline risk of cancer and other diseases. Under the terms of the agreement, PreventionGenetics received total consideration of $190 million, comprised of 50% in Exact Sciences common stock and 50% in cash. PreventionGenetics expects preliminary, unaudited 2021 revenue of approximately $36 million and $3 million in adjusted EBITDA.

18:56 EST James Hardie Industries announces management appointments - James Hardie announced the appointment of Ryan Kilcullen as Senior Vice President, Global Operations, and the appointment of John Arneil as General Manager of Asia Pacific.

16:45 EST BioMarin announces results from ongoing global Phase 3 GENEr8-1 study - BioMarin Pharmaceutical announced results from its ongoing global Phase 3 GENEr8-1 study of valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A. This is the largest global Phase 3 study to date for any gene therapy in hemophilia, with 134 participants. In the GENEr8-1 Phase 3 study, Annualized Bleeding Rate was significantly reduced by 4.1 treated bleeds per year, or 85% from a baseline mean of 4.8, in the pre-specified primary analysis in participants from a prior non-interventional study. The mean ABR was 0.8 through the entire efficacy evaluation period, 0.9 during year one, and 0.7 during year two. Valoctocogene roxaparvovec also significantly reduced the mean annualized Factor VIII infusion rate in the rollover population by 133 infusions per year or 98% from baseline. The mean annualized infusion rate was 2.6 through the entire efficacy evaluation period, 1.5 during year one, and 3.4 during year two. At the end of the second year post-infusion with valoctocogene roxaparvovec, participants in the modified intent-to-treat population had a mean endogenous Factor VIII activity level of 23.0 IU/dL, as measured by the chromogenic substrate assay and 36.1 IU/dL, as measured by the one-stage assay. In a subset of the mITT population that had been dosed at least three years prior to the data cut, mean Factor VIII activity was 16.8 IU/dL by CS assay and 27.0 IU/dL by OS assay at the end of year three. The mean cumulative ABR for this subpopulation was 0.7 through the entire efficacy evaluation period and 0.6 during year three. BioMarin plans to present additional data from this study at upcoming medical meetings. Overall, in the Phase 3 study, valoctocogene roxaparvovec has continued to be well tolerated. All participants received a single 6e13 vg/kg dose. No participants developed inhibitors to Factor VIII, malignancy, or thromboembolic events. During year two, no new safety signals emerged, and no treatment-related serious adverse events were reported. Most patients had discontinued any corticosteroid use in year one, and there were no CS-related SAEs in the remaining patients being tapered off CS in year two. Overall, the most common adverse events associated with valoctocogene roxaparvovec occurred early and included transient infusion associated reactions and mild to moderate rise in liver enzymes with no long-lasting clinical sequelae. The European Medicines Agency validated BioMarin's resubmission of a Marketing Authorization Application and a Committee for Medicinal Products for Human Use and Committee for Advanced Therapies opinion is anticipated in the first half of 2022. In the United States, BioMarin intends to submit two-year follow-up safety and efficacy data on all study participants from the Phase 3 GENEr8-1 study to support the benefit/risk assessment of valoctocogene roxaparvovec, as previously requested by the Food and Drug Administration. Based on these results, BioMarin is planning to meet with FDA to discuss the resubmission of a Biologics License Application targeted for the second quarter of 2022, followed by an expected six-month review by the FDA. Valoctocogene roxaparvovec has received both Regenerative Medicine Advanced Therapy designation and Breakthrough Therapy Designation from FDA, which are intended to expedite development of drugs for serious or life-threatening diseases and conditions. In addition to the RMAT Designation and Breakthrough Therapy Designation, valoctocogene roxaparvovec also has received Orphan Drug Designation from the FDA and EMA for the treatment of severe hemophilia A.

14:38 EST Caesars Sportsbook debuts mobile sports betting in New York - After being named one of the first operators to receive a license for mobile sports wagering operations in the state, Caesars Entertainment has "made history with its online and mobile sports betting app, Caesars Sportsbook, accepting its first sports wagers in the Empire State," the company said. Caesars Sportsbook brings its customer loyalty program, Caesars Rewards, to New York. With mobile sports betting officially live, eligible New Yorkers can download the Caesars Sportsbook app, register, deposit funds and jump right into the action with launch offers to commemorate this historic moment. Caesars Sportsbook is currently live in 21 states and jurisdictions - 15 of which are mobile.

14:30 EST Embark sees 'number of issues and mischaracterizations' with Bear Cave's report - Contacted by The Fly regarding a report by The Bear Cave's Edwin Dorsey titled "Problems at Embark Technology," a spokesperson for the company said that, "We believe there are a number of issues and mischaracterizations with the report that render it misleading and arise from having no first hand knowledge of the business and selectively highlighting public filings out of context, to generate content for their paid subscribers. We continue to be focused on executing against our long-term business plan and building world-class technology."