Stockwinners Market Radar for August 28, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

GOOG...

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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. Facebook parent Meta Platforms (META) agreed to settle a lawsuit that accused the social-media platform of allowing third parties, including Cambridge Analytica, to access private user data, The Wall Street Journal's Jennifer Hiller reported, citing a court filing. Meta and the Facebook users suing the company said in the joint filing that they had reached an agreement in principle but didn't provide financial or other details. The two sides requested a 60-day stay of the lawsuit, which followed revelations that Cambridge Analytica, a now-defunct British consulting firm that worked on former President Donald Trump's 2016 campaign, had improperly obtained and exploited Facebook user data, the author noted. 2. Dell Technologies (DELL) said on Saturday it had ceased all Russian operations after closing its offices in mid-August, the latest in a growing list of Western firms to exit Russia, according to Reuters. The U.S. computer firm, a vital supplier of servers in Russia, has joined others in curtailing operations since Moscow sent tens of thousands of troops into Ukraine on Feb. 24. 3. Cablers and broadcasters also face the imminent arrival of serious new competition for advertising dollars, as Netflix (NFLX) plots the debut of an ad-supported subscription tier for early 2023, but the cable audience could be even smaller if more sports shift to streaming, Eric J. Savitz wrote in this week's edition of Barron's. One wild card is what happens to NFL Sunday Ticket, which lets football fans watch out-of-market Sunday afternoon games. DirecTV has had the rights to Sunday Ticket since 1994, but that deal runs out after the coming season. There's an intense bidding war to take control of the service, with bidders reportedly including Apple (AAPL), Amazon.com (AMZN), Alphabet (GOOGL), and Disney (DIS), the author noted. Apple has the deepest pockets. It has been aggressively seeking sports programming to boost Apple TV+. 4. Sony's (SONY) "The Invitation" won the slow weekend at the North American box office with a domestically total of $7M from 3,114 theaters. Overseas, the horror movie earned $1.6M from 19 markets for a global start of $8.6M. 5. T-Mobile (TMUS), Juniper Networks (JNPR), Deutsche Telekom (DTEGY), Alcoa (AA), American Water Works (AWK), Danaher (DHR), Essential Utilities (WTRG), Evoqua (AQUA), Mueller Water Products (MWA) and Xylem (XYL) saw positive mentions in this week's edition of Barron's, while Nvidia (NVDA) was mentioned cautiously.
MDT

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15:09 EDT Medtronic presents data from EV ICD study at ESC Congress - Medtronic announced that its investigational EV ICD System - a first-of-its-kind defibrillator with the lead placed under the breastbone, outside of the heart and veins - achieved a defibrillation success rate of 98.7% and met its safety endpoints in a global clinical trial. Findings from the Extravascular Implantable Cardioverter Defibrillator, or EV ICD, Pivotal Study were presented as late-breaking science at the European Society of Cardiology ESC Congress 2022 in Barcelona and simultaneously published in The New England Journal of Medicine. Worldwide, the EV ICD system is investigational and not yet approved for sale or distribution. The Medtronic EV ICD system is designed to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest, while avoiding certain risks of traditional, transvenous ICDs because its lead is placed outside the heart and veins, under the breastbone using a minimally invasive approach. Placing the lead in this location is designed to help avoid long-term complications that may be associated with leads in the heart and veins, such as vessel occlusion and risks for blood infections. The lead is connected to a device that is implanted below the left armpit. Clinical trial participants received the same therapies provided by traditional ICDs, including defibrillation, anti-tachycardia pacing, and back-up pacing therapies with this single implanted device that is similar in size, shape, and longevity to traditional ICDs.
AMRN

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15:06 EDT Amarin presents new REDUCE-IT data at European Society of Cardiology - Amarin Corporation announced that new REDUCE-IT data show that VASCEPA/VAZKEPA significantly reduced cardiovascular events in patients with a history of smoking. In this post hoc exploratory analysis of REDUCE-IT, icosapent ethyl treatment significantly reduced the risk of fist and total primary composite events in current/former smokers by 23% and in former smokers by 29%, compared to patients who were assigned to placebo. IPE treatment reduced the incidence of CV events in current smokers by 23.8% and former smokers by 23.0% to levels observed in never smokers in the placebo group. These data were presented during an Oral Abstract session at the European Society of Cardiology Congress 2022 in Barcelona, Spain and published in EHJ Cardiovascular Pharmacotherapy. In the study, investigators sought to evaluate the effects of IPE on the risk of CV events and safety measures in patients by history of smoking. The effects of IPE on first and total primary and key secondary endpoints were evaluated in the REDUCE-IT study using post hoc exploratory analyses based upon smoking history. Groups were classified as never smokers, former smokers, and current smokers. Compared with placebo, IPE use in combined current and former smokers was associated with significant reductions in first primary composite events and in total primary composite events. Overall, there were similar estimated rates of first occurrences of CV death, MI, stroke, coronary revascularization, or hospitalization for unstable angina in current smokers and former smokers assigned to IPE compared with never smokers assigned to placebo. Limitations include that REDUCE-IT was not powered for subgroup analyses.
BMY

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14:57 EDT Bristol-Myers presents results from Phase 2 AXIOMATIC-SSP study of milvexian - Bristol Myers Squibb (BMY) in collaboration with Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), announced results from the Phase 2 AXIOMATIC-SSP dose-ranging study of the investigational oral factor XIa inhibitor, milvexian, which showed an approximate 30% relative risk reduction in recurrent symptomatic ischemic strokes and favorable safety profile in three arms compared to placebo when used in combination with background antiplatelet therapy in patients with an acute non-cardioembolic ischemic stroke or transient ischemic attack. The primary objective of this study was to detect a dose response for the composite endpoint of symptomatic ischemic stroke + MRI detected covert brain infarction across a 16-fold dose range; a dose response was not observed. A relative risk reduction of approximately 30% in symptomatic ischemic stroke with milvexian was observed in patients receiving either 25, 50 or 100 mg twice daily compared to placebo. These data were presented in a Hot Line session at the European Society of Cardiology Congress 2022. There was no increase in severe bleeding versus placebo, and there was no fatal bleeding in any arm of the study, even with all patients on background dual antiplatelet therapy for 21 days followed by single antiplatelet therapy for the duration of the trial. The rate of major bleeding for milvexian 25 mg once daily and twice daily doses was similar to placebo, while a numerical increase was observed in milvexian dose arms of 50 mg twice daily and above, with no dose-response. The AXIOMATIC-SSP study is the second study to read out from the AXIOMATIC program and completes milvexian's Phase 2 development.
AZN

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14:53 EDT AstraZeneca presents pooled analysis from Phase III DAPA-HF, DELIVER trials - New results from a pre-specified, patient level, pooled analysis from the Phase III DAPA-HF and DELIVER trials demonstrated mortality benefit of FARXIGA, compared to placebo, in patients with heart failure. These results were presented at the European Society of Cardiology Congress 2022 in Barcelona, Spain and simultaneously published in Nature Medicine. The reduction in risk of cardiovascular death was consistent across pre-specified subgroups and is the first analysis to demonstrate a mortality benefit with an HF medication in patients with HF across the left ventricular ejection fraction range. The analysis showed that FARXIGA reduced the risk of CV death by 14% over the median follow-up of 22 months, death from any cause by 10%, total hospitalization for HF by 29%, and the composite of death from CV causes, myocardial infarction, or stroke by 10%, in patients with HF irrespective of LVEF. The DAPA-HF and DELIVER Phase III trials were randomized and double-blind, comparing FARXIGA to placebo. Each trial enrolled patients with a diagnosis of HF, functional limitation, and elevated natriuretic peptides. The principal difference between the two trials was that patients with an LVEF of 40% or less were randomized in DAPA-HF and those with a LVEF greater than 40% in DELIVER. The studies included 11,007 individuals with HF across 20 countries in each trial.
AZN

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14:48 EDT AstraZeneca presents detailed results from DELIVER Phase III trial - Detailed results from the DELIVER Phase III trial showed AstraZeneca's FARXIGA significantly reduced the composite of cardiovascular death or worsening heart failure in patients with HF and mildly reduced or preserved ejection fraction, compared to placebo. The results were presented at the European Society of Cardiology Congress 2022 in Barcelona, Spain, and simultaneously published in The New England Journal of Medicine. FARXIGA reduced the composite outcome of CV death or worsening of HF by 18%. All individual components contributed to the superiority of the primary endpoint. The findings were consistent across key subgroups examined and extend the benefits of FARXIGA to the full spectrum of patients with HF irrespective of left ventricular ejection fraction status. The trial results also showed a symptom benefit in patient-reported outcomes measured by the Kansas City Cardiomyopathy Questionnaire total symptom score. The updated 2022 joint HF guidelines issued by the American College of Cardiology, the American Heart Association and the Heart Failure Society of America, now recommend sodium-glucose cotransporter 2 inhibitors such as FARXIGA for HF with mildly reduced EF and HF with preserved EF. This expands upon previous recommendations supporting the use of SGLT2 inhibitors in HF with reduced EF. DELIVER was designed with broader inclusion criteria than prior trials in this patient population to also include patients who were hospitalized, recently hospitalized, or those with HF with improved LVEF, for whom evidence-based therapy is limited. These findings build upon the previously reported results from DAPA-HF, the only SGLT2 inhibitor outcomes trial in HF to demonstrate a significant reduction in mortality, to provide further evidence to support the use of FARXIGA as foundational therapy for patients with HF, regardless of EF. The safety and tolerability profile of FARXIGA in the DELIVER Phase III trial was consistent with the well-established safety profile of the medicine.
HIL

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14:44 EDT GISI, Hill International announce enhancements to strategic merger agreement - Global Infrastructure Solutions, or GISI, and Hill International announced that their boards of directors have approved enhancements to their definitive agreement of August 16, 2022, wherein they agreed to merge the diversified construction management companies, setting the stage for increased competitiveness and accelerated organic growth in global, for-fee infrastructure consulting markets. Following the receipt of an unsolicited proposal from a third party, Hill and GISI negotiated an amended and restated Merger Agreement under the terms of which the per share price is $3.40, the transaction remains all-cash, and there is no financing contingency. Further, the transaction structure has been changed to a merger requiring the approval of Hill's stockholders. The transaction is expected to close in the fourth quarter of 2022, pending stockholder approval and regulatory review. The parties have also agreed to work together, if requested to do so by Hill, in order to provide Hill interim capital to allow Hill to take advantage of ongoing organic growth opportunities prior to closing.