Stockwinners Market Radar for September 02, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:41 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. Tension between Boeing (BA) and international air-safety authorities could delay the grounded 737 Max fleet from getting back into service, Andy Pasztor and Alison Sider reported, citing government and pilot union officials briefed on the matter. The friction stems from a Boeing briefing in August that was cut short by regulators from the U.S., Europe, Brazil and elsewhere, who complained that company failed to provide technical details and answer specific questions about modifications in the operation of Max flight-control computers, the authors wrote. As a result, Boeing has to resubmit briefing documents describing proposed software changes, sources told the Journal. The changes then have to be vetted by the U.S. Federal Aviation Administration before a follow-up meeting with the same participants can be held and simulator and flight tests of the final software revisions scheduled. Additional weeks of delay could significantly reduce the likelihood that the 737 Max is back in the air during the Christmas holidays, Pasztor and Sider added. 2. The U.S. and Poland believe suppliers of 5G network equipment should be rigorously evaluated for foreign government control, Alan Charlish and Marcin Goclowski reported, citing a joint declaration signed on Monday. Chinese telecoms giant Huawei Technologies has denied U.S. accusations that its equipment provides back doors for Beijing's intelligence agencies, at a time when the two nations are embroiled in a trade war, the authors noted. 3. The retail sector continues to split into winners and losers, with the trend toward convenience and low prices has elevated discounters and big box stores, but has left other retailers in a riskier position, Avi Salzman wrote in this week's edition of Barron's. For instance, Best Buy (BBY) fell even after reporting better-than-expected earnings, Tiffany (TIF) stock wobbled after management reported higher earnings than expected but said that the pro-democracy protests in Hong Kong had disrupted business there, while Ulta Beauty (ULTA) tumbled after missing earnings forecasts and lowering its guidance. Discounters, however, continue to impress Wall Street, the author noted, with Five Below (FIVE) up even though same-store sales fell short of expectations, Dollar General (DG) reporting much better than expected results, and Burlington Stores (BURL) soaring 18%. 4. Lionsgate's (LGF.A) "Angel has Fallen" won the long Labor Day weekend with an estimated $14.8M for the four-day holiday, in its second outing. The movie is expected to finish Monday with a 10-day domestic cume of $44M. "Angel has Fallen" received an A- CinemaScore and 40% on Rotten Tomatoes. 5. Translate Bio (TBIO), Moderna (MRNA), and Activision Blizzard (ATVI) saw positive mentions in this week's edition of Barron's.

14:39 EDT S&P Global Platts acquires Live Rice Index - S&P Global Platts announced it has acquired Live Rice Index. The purchase expands Platts portfolio of agricultural price assessments while extending its data and news coverage in key export regions for international grains. The addition of LRI broadens S&P Global Platts agriculture coverage beyond grains, oilseeds, vegetable oils, animal feed & protein, sugar and biofuels and supports Platts global growth in agriculture markets more generally. In the past year alone, Platts has launched a range of new daily physical price assessments in global soybeans, Argentinean and Brazilian corn, Black Sea sunflower oil and an Asian palm oil complex. S&P Global Platts is a division of S&P Global.

14:27 EDT The Medicines Co. presents results from Phase 3 ORION-11 trial of Inclisiran - The Medicines Co. announced the presentation of results from ORION-11, its first pivotal Phase 3 clinical study of inclisiran, an investigational twice-yearly therapy to reduce low-density lipoprotein cholesterol and the first and only cholesterol-lowering therapy in the siRNA class. In ORION-11, twice-yearly dosing with inclisiran sodium 300 mg met all primary and secondary efficacy endpoints, was well-tolerated and demonstrated an excellent safety profile. For the primary endpoints of ORION-11, inclisiran delivered placebo-adjusted LDL-C reductions of 54% at day 510 and demonstrated time-averaged placebo-adjusted LDL-C reductions of 50% from days 90 through 540. The overall adverse event profiles of the placebo- and inclisiran-treated groups in ORION-11 were similar. A similar proportion of patients in the placebo- and inclisiran treated groups experienced at least one serious treatment emergent adverse event. The incidence of deaths and malignancies was similar between the placebo and inclisiran groups, respectively. A difference between placebo and inclisiran was observed in the incidence of fatal and non-fatal myocardial infarctions and fatal and non-fatal strokes. Clinically relevant elevations in liver function tests and serum creatinine increases were similar between the placebo and inclisiran groups, respectively. The incidence of clinically relevant injection site reactions between the placebo and inclisiran groups was infrequent, with events predominantly mild and transient. ORION-11 data will be submitted to a peer-reviewed medical journal. The sequential release of topline Phase 3 data readouts for the ORION-9 and ORION-10 studies is expected to continue later in the third quarter in advance of anticipated regulatory submissions in the U.S. in the fourth quarter of 2019 and in Europe in the first quarter of 2020. Patients who have completed their respective Phase 3 studies are now enrolling into ORION-8, an open-label, long-term extension study where patients completing ORION-9, ORION-10 and ORION-11 will receive inclisiran for three years to evaluate the efficacy, safety and tolerability of long-term dosing of inclisiran.

14:12 EDT Genentech presents Phase 3 MINISTONE-2 study results for one-dose Xofluza - Genentech, a member of the Roche, announced that the Phase III MINISTONE-2 study showed that one-dose Xofluza was a well-tolerated and effective potential treatment for the flu in otherwise healthy children aged one to less than 12 years old. The study met its primary endpoint, which evaluated the proportion of patients with adverse events or severe AEs up to study day 29, demonstrating results consistent with the safety profile of Xofluza. In Xofluza-treated participants, 46.1% experienced at least one treatment-emergent AE compared to 53.4% in the oseltamivir arm. The study also showed the efficacy of Xofluza to be comparable to oseltamivir. In addition, consistent with data in adults and adolescents, Xofluza reduced the length of time that the flu virus continued to be released from the body by more than two days compared with oseltamivir. MINISTONE-2 is the first global Phase III study for Xofluza in children. It showed that Xofluza was comparable to oseltamivir in relation to key secondary endpoints, including time to alleviation of influenza signs and symptoms. This is the fourth positive Phase III study for Xofluza, which has now demonstrated benefit in several populations and treatment settings. Xofluza is being further studied in an ongoing Phase III development program, including children under one year, severely ill hospitalized people with the flu, and to assess the potential to reduce transmission of the flu from an infected person to healthy people.

14:03 EDT AstraZeneca announces detailed results from Phase 3 DAPA-HF trial - AstraZeneca announced detailed results from the landmark Phase III DAPA-HF trial that showed FARXIGA on top of standard of care reduced both the incidence of cardiovascular death and the worsening of heart failure. DAPA-HF is the first outcomes trial with an SGLT2 inhibitor investigating the treatment of heart failure in patients with reduced ejection fraction, with and without type 2 diabetes. FARXIGA is currently approved to improve glycemic control in patients with T2D. Top-line results announced in August 2019 showed DAPA-HF met the primary endpoint. The detailed results of the trial presented at the ESC Congress 2019 showed FARXIGA reduced the composite of CV death or worsening of heart failure by 26% and showed a reduction in each of the individual components of the composite endpoint. FARXIGA is not indicated to reduce the risk of heart failure or CV death. In analyzing each of the components of the primary composite endpoint, there was a 30% decrease in the risk of experiencing a first episode of worsening heart failure and an 18% decrease in the risk of dying from CV causes. The effect of FARXIGA on the primary composite endpoint was generally consistent across the key subgroups examined. The trial results also showed a significant improvement in patient reported outcomes measured by the Kansas City Cardiomyopathy Questionnaire total symptom score and a nominally significant reduction in all-cause mortality by 17% in favor of FARXIGA. The safety profile of FARXIGA in the DAPA-HF trial was consistent with the well-established safety profile of the medicine. The proportion of patients with volume depletion and renal adverse events, which are commonly of concern when treating heart failure, were comparable to placebo. Major hypoglycemic events were rare in both treatment groups. FARXIGA is also being studied in patients with heart failure with preserved ejection fraction in the DELIVER and DETERMINE trials.

13:53 EDT MyoKardia presents data from PIONEER-OLE study of Mavacamten - MyoKardia presented positive data from the company's PIONEER open-label extension study of mavacamten for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy at the European Society of Cardiology Congress 2019, in Paris, France. The PIONEER-OLE study enrolled 13 patients from the Phase 2 PIONEER-HCM study of mavacamten, and 12 patients were evaluable at 36 weeks. Patients received once-daily oral doses of mavacamten individually adjusted to target concentrations to eliminate the obstruction of the left ventricular outflow tract. Mavacamten treatment resulted in reductions in patients' resting and provoked LVOT gradient while maintaining a left ventricular ejection fraction above 55% at all times of assessment during the study through week 36. Mavacamten was well tolerated throughout the treatment period, with no cardiac-related adverse events attributed to study drug. The longest continual duration of mavacamten treatment is now 1.3 years.