Stockwinners Market Radar for October 31, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

HOG...

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20:07 EDT Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. The United States and the European Union on Sunday ended a dispute over steel and aluminum tariffs and said they would work on a global arrangement to combat "dirty" production and overcapacity in the industry, Reuters' Jeff Mason and Jan Strupczewski reported. The future EU-U.S. arrangement will be a challenge for China, which produces more than half of the world's steel and which the EU and U.S. accuse of creating overcapacity that is threatening the survival of their own steel industries, the authors noted. Under the deal, Washington will allow EU countries duty free access for steel and aluminum exports to the United States in volumes comparable to those shipped before tariffs imposed by former President Donald Trump's administration in 2018. In response, the EU removed retaliatory tariffs on U.S. products including whiskey, power boats and Harley-Davidson (HOG) motorcycles. Publicly traded companies in the space include AK Steel (AKS), ArcelorMittal (MT), Nucor (NUE), Steel Dynamics (STLD), TimkenSteel (TMST) and U.S. Steel (X). 2. Moderna (MRNA) provided an update that the U.S. Food and Drug Administration has notified the company that it will require additional time to complete its assessment of Moderna's Emergency Use Authorization request for the use of the Moderna COVID-19 vaccine at the 100 microgram dose level in adolescents 12 to 17 years of age. On Friday evening, the FDA informed Moderna that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination. The FDA notified Moderna that this review may not be completed before January 2022. Moderna will delay filing a request for EUA of mRNA-1273 at the 50 microgram dose level in the pediatric population while the FDA completes its review of the adolescent EUA request. 3. Ford (F) has big plans to win the battle for battery supremacy, but it's not the only one, with General Motors (GM) also planning to spend $35B on vehicle electrification by 2025 and Volkswagen (VWAGY) planning to build six battery facilities in Europe by 2030, Al Root wrote in this week's edition of Barron's. Tesla (TSLA), with a big lead over the legacy auto makers, is still investing in battery capacity and technology, the author noted. Auto manufacturers know that the industry has to grow battery capacity fourfold by the middle of the 2020s to meet companies' announced EV goals. Battery manufacturing also has to get much more efficient to bring down the costs, the publication added. 4. AT&T (T) subsidiary Warner Bros.' "Dune" won the domestic box office with a strong $40.1M debut despite its dual release as it opened simultaneously in 4,125 theaters across North America and on streamer HBO Max. Globally, the movie moved past the $100M mark after opening previously in earlier markets. "Dune" grossed another $47.4M from 75 markets overseas for a foreign cume of $180.6M and $220.2M globally. 5. Madison Square Garden Sports (MSGS), MSG Entertainment (MSGE), AMC Networks (AMCX), Sonos (SONO), Cinemark (CNK) and Siemens (SIEGY) saw positive mentions in this week's edition of Barron's.
FLO

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15:51 EDT Flowers Foods issues voluntary recall on certain Tastykake multi-pack cupcakes - As a precautionary measure, Flowers Foods is voluntarily recalling Tastykake multi-pack cupcakes due to the potential presence of tiny fragments of metal mesh wire. The recall was initiated following notification by a vendor of the possible contamination in a supplied ingredient. The products being recalled were distributed to retail customers in Delaware, Maryland, New Jersey, New York, Pennsylvania, Virginia, Washington DC, and West Virginia. No injuries or incidents have been reported in connection with the recalled items.
BF.B BF.A

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15:48 EDT Brown-Forman issues statement on U.S.-EU trade agreement - Brown-Forman said in a statement that it "applauds the Biden Administration for today's announcement between the U.S. and the EU regarding steel and aluminum tariffs. This agreement delivers on the Administration's promise to rebuild the Transatlantic alliance by removing tariffs on American whiskey and other U.S. exports, which have been in place now for more than three years. Brown-Forman looks forward to the return of a level playing field on January 1, 2022, and continued international growth for American Whiskey. We hope a similar outcome can soon be achieved between the U.S. and the UK."
MRK

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15:40 EDT Merck announces new data from studies evaluating KEYTRUDA - Merck, known as MSD outside the United States and Canada, has announced new data from studies evaluating KEYTRUDA, Merck's anti-PD-1 therapy, at the Society for Melanoma Research 2021 Congress. Key data include exploratory 7-year follow-up from KEYNOTE-006, the pivotal trial that supported the indication for KEYTRUDA in advanced melanoma, and updated findings from the KEYNOTE-716 trial that is evaluating KEYTRUDA as an adjuvant treatment for patients with resected stage IIB or IIC melanoma. These data were both selected for inclusion in plenary sessions at the SMR 2021 Congress. KEYNOTE-006 was an open-label, randomized Phase 3 study comparing the efficacy and safety of KEYTRUDA versus ipilimumab in participants with advanced melanoma. After KEYNOTE-006 concluded, participants were eligible to transition to KEYNOTE-587 for extended follow-up. 210 former participants of KEYNOTE-006 were assessed for 7-year follow-up. Findings from this long-term follow-up showed that median OS was 32.7 months for KEYTRUDA and 15.9 months for ipilimumab. The 7-year OS rates were 37.8% for KEYTRUDA and 25.3% for ipilimumab. Findings from this exploratory analysis showed that KEYTRUDA was associated with improved clinical outcomes regardless of BRAF status, prior BRAFi therapy, and poor prognostic characteristics such as high LDH level, larger tumor size, or presence of brain metastases. These results represent the longest follow-up from a Phase 3 trial of anti-PD-1/L1 therapy for advanced melanoma available to date. No formal statistical testing was planned. KEYNOTE-716 is a multicenter, randomized, double-blind Phase 3 trial evaluating adjuvant treatment with KEYTRUDA compared to placebo in adult and pediatric patients with resected stage IIB or IIC melanoma. The trial's primary endpoint is recurrence-free survival. At the protocol-specified second interim analysis, treatment with KEYTRUDA continued to show a clinically meaningful improvement in RFS compared to placebo as adjuvant therapy for these patients, with a reduction in the risk of disease recurrence or death of 39%. As previously announced, KEYNOTE-716 met the primary endpoint of RFS at the first interim analysis, and therefore, statistical testing was not performed at IA2. No new safety signals were observed. At IA2, 14.8% of patients who received KEYTRUDA had recurrence or died compared to 23.5% of patients on placebo. Median RFS continued to not be reached for either group at the time of this analysis. Twice as many patients on placebo. The safety profile of KEYTRUDA at IA2 was consistent with previous reports. Treatment-related adverse events occurred in 82.8% of patients who received KEYTRUDA versus 63.4% of patients who received placebo, while Grades 3-4 TRAEs were observed in 17.0% versus 4.3% of patients, respectively. Grades 3-4 immune-mediated adverse events and infusion reactions occurred in 10.1% of patients and 1.2% of patients in the KEYTRUDA and placebo arms, respectively.
MRNA

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15:33 EDT Moderna says FDA needs more time to complete review of COVID-19 shot for teens - Moderna provided an update that the U.S. Food and Drug Administration has notified the company that it will require additional time to complete its assessment of Moderna's Emergency Use Authorization request for the use of the Moderna COVID-19 vaccine at the 100 microgram dose level in adolescents 12 to 17 years of age. On Friday evening, the FDA informed Moderna that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination. The FDA notified Moderna that this review may not be completed before January 2022. The safety of vaccine recipients is of paramount importance to Moderna. The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence. An increased risk of myocarditis has been described for COVID-19 vaccines, including the Moderna COVID-19 vaccine, particularly in young men and following the second dose. The U.S. Centers for Disease Control and Prevention and the World Health Organization have stated that myocarditis following vaccination with mRNA vaccines has been rare and generally mild. Moderna will delay filing a request for EUA of mRNA-1273 at the 50 microgram dose level in the pediatric population while the FDA completes its review of the adolescent EUA request.
CLF

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15:30 EDT Cleveland-Cliffs comments on U.S.-EU steel Section 232 agreement - Cleveland-Cliffs issued a statement regarding the announcement by President Biden's Administration of an alternative steel Section 232 arrangement between the United States and the European Union. Lourenco Goncalves, Cleveland-Cliffs' Chairman, President and Chief Executive Officer, said, "Today's announcement of an alternative Section 232 measure with the EU is evidence that President Biden and his Administration understand the critical role of the steel Section 232 program in providing a level playing field for American companies and workers. This tariff rate quota arrangement will guard against a harmful surge of steel imports from the EU. The agreement recognizes that the United States has the most environmentally friendly steel industry in the world. Cleveland-Cliffs produces high-quality flat-rolled steel products with all stages of production occurring in the United States, from the mining of key raw materials through melting and finishing. In furtherance of Cleveland-Cliffs' commitment to decarbonization, the company has spent more than $1 billion since 2017 to build the world's most technologically-advanced direct reduction plant in Toledo, Ohio. This plant produces hot briquetted iron that is 70% less CO2 intensive than imported metallics such as pig iron."
TEVA

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15:27 EDT Teva announced results from pivotal Phase 3 RISE study - Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, announced results from the pivotal Phase 3 Risperidone Subcutaneous Extended-release study comparing TV-46000/mdc-IRM once monthly and TV-46000/mdc-IRM once every two months with placebo in patients with schizophrenia who underwent stabilization on oral risperidone. Results showed treatment with TV-46000 significantly prolonged time to relapse, decreased proportions of patients with impending relapse at week 24 and demonstrated significant increase in proportions maintaining stability. The safety profile of TV-46000, as demonstrated in this study, is consistent with other formulations of risperidone. The most common adverse reactions were nasopharyngitis, increased weight, and extrapyramidal disorder. These findings, among others, were presented during the poster session at the 2021 Psych Congress Annual Meeting taking place Oct. 29-Nov. 1, 2021 in San Antonio, TX.
HOG

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15:25 EDT Harley-Davidson issues statement on EU tariff resolution - Responding to the announcement from President Biden, Harley-Davidson "extends its thanks to the U.S. Administration for reaching a solution to the 232-tariff dispute." "Today's news is a big win for Harley-Davidson and our customers, employees and dealers in Europe. Our thanks go out to President Biden, Secretary Raimundo and the U.S. Administration, for their efforts in this negotiation. We are excited that this brings an end to a conflict that was not of our making, and in which Harley-Davidson had no place. This is an important course correction in U.S.-EU trade relations, that will allow us to further Harley-Davidson's position as the most desirable motorcycle brand in the world," said Jochen Zeitz, Chairman, President and CEO of Harley-Davidson.
KSU CP

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15:04 EDT Canadian Pacific, Kansas City Southern file merger application with STB - Canadian Pacific Railway (CP) and Kansas City Southern (KSU) announced they have jointly filed a railroad control application with the Surface Transportation Board regarding the proposed transaction to create Canadian Pacific Kansas City. CP has agreed to acquire KCS in a stock and cash transaction representing an enterprise value of approximately $31 billion, which includes the assumption of $3.8 billion of outstanding KCS debt. The transaction, which has the unanimous support of both boards of directors, values KCS at $300 per share, representing a 34 percent premium, based on the CP closing price on Aug. 9, 2021, the date prior to which CP submitted a revised offer to acquire KCS, and KCS' unaffected closing price on March 19, 2021. The transaction is subject to approval by shareholders of each company along with satisfaction of customary closing conditions, including Mexican regulatory approvals. Shareholders are expected to vote on the transaction later this year. CP's ultimate acquisition of control of KCS' U.S. railways is subject to the approval of the STB. In April 2021, the STB determined it would review the CP-KCS combination under the merger rules in existence prior to 2001 and the waiver granted to KCS in 2001 to exempt it from the 2001 merger rules. In August 2021, the STB reaffirmed that the pre-2001 rules would govern its review of the CP-KCS transaction. On Sept. 30, 2021, the STB confirmed that it has approved the use of a voting trust for the CP-KCS combination. The STB review of CP's proposed control of KCS is expected to be completed in the second half of 2022. Upon obtaining control approval, the two companies will be integrated fully over the ensuing three years, unlocking the benefits of the combination.
VMW DELL

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15:00 EDT Dell announces distribution ratio for VMware spinoff special dividend - Dell (DELL) announced that the final distribution ratio for the special dividend of its shares of VMware (VMW) Class A common stock and Class B common stock to Dell Technologies stockholders is .440626. Accordingly, Dell Technologies stockholders will receive .440626 of a share of VMware Class A common stock for each share of Dell Technologies common stock held as of 5:00 p.m. ET on October 29, 2021. Each share of VMware Class B common stock will be converted into one share of VMware Class A common stock in connection with the distribution and prior to the receipt by Dell Technologies' stockholders of such shares. Dell Technologies stockholders will receive cash in lieu of any fractional shares of VMware Class A common stock. The distribution is expected to be completed on November 1, 2021, following the satisfaction of certain closing conditions.