Stockwinners Market Radar for June 14, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:39 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. AstraZeneca (AZN) has reached an agreement with Europe's Inclusive Vaccines Alliance, or IVA, spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400M doses of the University of Oxford's COVID-19 vaccine, with deliveries starting by the end of 2020, the company announced. "With the agreement, the IVA aims to accelerate the supply of the vaccine and to make it available to other European countries that wish to participate in the initiative. The IVA is committed to providing equitable access to all participating countries across Europe. AstraZeneca continues to build a number of supply chains in parallel across the world, including for Europe. The company is seeking to expand manufacturing capacity further and is open to collaborating with other companies in order to meet its commitment to support access to the vaccine at no profit during the pandemic," AstraZeneca stated. 2. Carlos Ghosn always said he was set up and now there seems to be some evidence to support his claim, Bloomberg's Reed Stevenson reported. According to people familiar with what happened and previously unreported internal correspondence, the campaign by top Nissan (NSANY) executives to dethrone one of the most celebrated leaders in the automotive industry started almost a year before Ghosn's arrest in late 2018 for alleged financial misconduct, the author noted. 3. Eating at home may not end even when COVID-related lockdowns do, which are good news for packaged-food companies, Teresa Rivas wrote in this week's edition of Barron's. Barron's previously argued that investors should buy into the group, given their valuation and ability to hold up better than other stocks through the crisis. Four of the five the publication recommended - Campbell Soup (CPB), Conagra (CAG), General Mills (GIS) and Kraft Heinz (KHC) - have outperformed the S&P500 year to date, with Kellogg (K) the only laggard. Of those, Campbell, Conagra, and General Mills remain some of the most appealing of the big packaged-food players, the author added. 4. Dr. Reddy's Laboratories (RDY) announced that it has entered into a non-exclusive Licensing Agreement with Gilead Sciences (GILD) that will grant Dr. Reddy's the right to register, manufacture and sell Gilead's investigational drug, Remdesivir, a potential treatment for COVID-19, in 127 countries including India. Dr. Reddy's will receive technology transfer from Gilead for manufacturing of this drug. Dr. Reddy's would need to do the manufacturing scale up and obtain regulatory approval for marketing of this drug in respective countries. Remdesivir, an investigational antiviral therapy developed by Gilead, received Emergency Use Authorization by the U.S. Food and Drug Administration to treat COVID-19. 5. Goldman Sachs (GS), Progressive (PGR), Home Depot (HD), Johnson & Johnson (JNJ), Lam Research (LRCX), McDonald's (MCD), NextEra Energy (NEE), Procter & Gamble (PG), Roche (RHHBY), Texas Instruments (TXN), MercadoLibre (MELI) and JD.com (JD) saw positive mentions in this week's edition of Barron's.

16:27 EDT Zealand presents clinical, non-clinical evidence for dasiglucagon rescue therapy - Zealand Pharma presented elaborated results from two Phase 3 clinical studies with dasiglucagon as treatment for severe hypoglycemia as well as one preclinical PK/PD study investigating aqueous versus DMSO formulations of glucagon and the pharmacodynamics of dasiglucagon in aqueous solution at the 80th Scientific Sessions of the American Diabetes Association held as a virtual meeting June 12-16, 2020. Dasiglucagon is a potential first-in-class soluble glucagon analog invented and developed by Zealand Pharma. The New Drug Application for the treatment of severe hypoglycemia with dasiglucagon has been accepted for review by the U.S. Food and Drug Administration and given a PDUFA target action date of March 27, 2021. In an oral presentation, Professor Tadej Battelino, Professor of Pediatrics, University Children's Hospital Ljubljna presented Dasiglucagon as a Fast and Effective Treatment for Severe Hypoglycemia in Children with Diabetes. This Phase 3, three-arm, parallel trial in 42 children in the age range of 6-17 years old with Type 1 diabetes, investigated the recovery from insulin-induced hypoglycemia with dasiglucagon versus placebo and with Glucagen as a reference. Primary and all secondary endpoints were met and demonstrated a median time to plasma glucose recovery of 10 minutes with dasiglucagon and 30 minutes for placebo and 10 minutes for Glucagen. Dasiglucagon showed adverse events consistent with known class effects. No serious or severe adverse events were reported. Timothy Bailey, President and CEO of AMCR Institute, presented a poster entitled Dasiglucagon HypoPal Autoinjector as a Fast and Effective Treatment for Severe Hypoglycemia: Results of a Phase 3 Trial. This Phase 3 parallel, two-arm study in 45 adults with Type 1 diabetes, investigated the recovery from insulin-induced hypoglycemia with dasiglucagon versus placebo. All primary and secondary endpoints were met and the median time to plasma glucose recovery was 10 minutes with dasiglucagon versus placebo 35 minutes. Dasiglucagon was generally safe and well-tolerated and these results were consistent with prior pivotal Phase 3 trials evaluating dasiglucagon administered via a pre-filled syringe. Carola Wenander, Principal Scientist, In Vivo Pharmacology at Zealand Pharma, presented a poster entitled PK/PD of Glucagon and the Novel Glucagon Analog, Dasiglucagon, in Aqueous or Non-Aqueous formulations following SC Administrations in Rats. This PK/PD study in male Sprague-Dawley rats characterized the pharmacokinetics of glucagon in aqueous formulation and that formulated in DMSO, and compared these to the pharmacodynamics of dasiglucagon in an aqueous formulation. The pharmacodynamic results of this preclinical model demonstrated that there was comparable blood glucose increase with glucagon and dasiglucagon in aqueous formulations. Glucagon in DMSO showed a delayed increase in blood glucose.

16:20 EDT Sinovac announces preliminary results of Phase 1/2 trials of COVID candidate - Sinovac Biotech announced positive preliminary results of phase I/II clinical trial for the company's COVID-19 vaccine candidate, named CoronaVac, which showed favorable immunogenicity and safety profiles. The phase I/II clinical trials were designed as randomized, double-blind and placebo-controlled studies. In total, 743 healthy volunteers, aged from 18 to 59 years old, enrolled in the trials. Of those, 143 volunteers are in phase I and 600 volunteers are in phase II. There have been no severe adverse event reported in either the phase I or phase II trials. The phase II clinical trial results show that the vaccine induces neutralizing antibodies 14 days after the vaccination with a 0,14 day schedule. The neutralizing antibody seroconversion rate is above 90%, which concludes the vaccine candidate can induce positive immune response. The company expects to submit a phase II clinical study report and a phase III clinical study protocol to China's National Medical Products Administration in the near future and commence application of phase III clinical trials outside of China. As previously announced on June 11, 2020, Sinovac is collaborating with Instituto Butantan in Brazil to prepare and conduct a phase III clinical study.

14:41 EDT Lexicon presents clinical data for Zynquista at ADA Scientific Sessions - Lexicon Pharmaceuticals presented six posters for Zynquista at the virtual 80th American Diabetes Association Scientific Sessions including additional efficacy and safety data patients with type 2 diabetes and moderate and severe renal impairment. In the Phase 3, multicenter, randomized, double-blind, placebo-controlled CKD-3 study, sotagliflozin was tested for superiority versus placebo in reducing A1C after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and moderate renal impairment. The study met its primary endpoint, demonstrating that sotagliflozin 400 mg significantly reduced A1C in the entire population of patients with moderate renal impairment compared to placebo at Week 26. The difference in least squares mean change in A1C from baseline for patients treated with sotagliflozin 400 mg compared to placebo was -0.24%. The change in A1C from baseline was not statistically different in patients treated with sotagliflozin 200 mg compared to placebo. The safety profile of sotagliflozin was generally similar to that of placebo. Incidences of symptomatic hypoglycemia were 20.4% on sotagliflozin 400 mg, 27.3% on sotagliflozin 200 mg, and 25% on placebo. The rates of symptomatic hypoglycemia were 114.0 on sotagliflozin 400 mg, 140.5 on sotagliflozin 200 mg, and 175.4 on placebo. In the Phase 3, multicenter, randomized, double-blind, placebo-controlled CKD-4 study, sotagliflozin was tested for superiority versus placebo in reducing A1C after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and severe renal impairment. The study did not meet its primary endpoint of demonstrating superiority of sotagliflozin versus placebo on A1C reduction after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and severe renal impairment compared to placebo. The placebo-adjusted difference in A1C from baseline for patients treated with sotagliflozin 400 mg compared to placebo was -0.29% at week 26. For sotagliflozin 200 mg, the placebo-adjusted difference in A1C was 0.05%. Several findings indicated clinically meaningful glycemic control over time was achieved with sotagliflozin 400 mg. From baseline to Week 52, the placebo-subtracted A1C reduction for sotagliflozin 400 mg was -0.69%. At Week 52, achievement of A1C less than or equal to 7% was seen in 20.7% of patients on sotagliflozin 400 mg compared to 6.5% on placebo. Over 52 weeks, the incidence of rescue therapy to treat hyperglycemia was 7.6% on sotagliflozin 400 mg and 15.1% on placebo. Results were consistent with a dose related-response, as the 200 mg dose group at Week 52 had a placebo-subtracted A1C reduction of -0.32%, 19.6% of patients achieved A1C less than or equal to 7%, and 10.9% required rescue therapy. The safety profile of sotagliflozin was generally similar to that of placebo. This was a population at high cardiovascular risk, and the incidences of major adverse cardiovascular events were 4.4% on sotagliflozin 400 mg, 1.1% on sotagliflozin 200 mg, and 11.9% on placebo. Incidences of symptomatic hypoglycemia were 27.8% on sotagliflozin 400 mg, 28.7% on sotagliflozin 200 mg and 35.5% on placebo, and the rates were 171.6 on sotagliflozin 400 mg, 226.9 on sotagliflozin 200 mg, and 269.8 on placebo.

14:31 EDT Abbott announces new data on use of FreeStyle Libre System - Abbott announced new late-breaking data demonstrating use of its FreeStyle Libre system is associated with "significant reduction in hemoglobin A1c (HbA1c) levels for people living with type 2 diabetes on either long-acting insulin or non-insulin therapy," according to the company. These results are similar to outcomes typically seen when adding insulin therapy to treatment regimens, indicating people may be able to manage their glucose levels with CGM technology instead of adding insulin. The real-world data were presented as a late-breaking abstract at the American Diabetes Association 80th Scientific Sessions. In an observational, retrospective study, researchers assessed changes in HbA1c levels in people with type 2 diabetes who were either on long-acting insulin or non-insulin therapy. They analyzed HbA1c levels from baseline to six months and baseline to 12 months after initiating use of the FreeStyle Libre system. The results demonstrated overall lower HbA1c levels associated with the use of Abbott's technology, specifically a 0.8% drop after six months and 0.6% drop after one year of FreeStyle Libre system use - clinically significant reductions of average glucose levels over time toward the ADA's recommended A1c goal of 7% for adults with diabetes. Additional notable findings showed: The greatest HbA1c decreases occurred among the non-insulin users with type 2 diabetes, including a 0.9% reduction at six months and 0.7% drop after 12 months; Among those people with type 2 diabetes on long-acting insulin, HbA1c reductions were 0.6% and 0.5% at six and 12 months, respectively. Two additional late-breaking abstracts assessed the impacts of using the FreeStyle Libre system in people living with type 2 diabetes not on intensive insulin therapy. A retrospective study found that a prescription for the FreeStyle Libre system in people with type 2 diabetes not on intensive insulin who had poor glucose control was associated with a substantial decrease in HbA1c, with the greatest reduction in those with higher baseline HbA1c levels. Specifically, A1c levels decreased 0.99% after six months in those on long-acting insulin and 1.56% after six months in those not on insulin. For those not using insulin, these results imply that using FreeStyle Libre technology can have a similar impact to using insulin therapy,4 meaning people could use the FreeStyle Libre system to manage their glucose levels instead of adding insulin. In a retrospective, observational analysis, researchers found that using the FreeStyle Libre system was associated with a sizeable reduction of 30% in acute diabetes events, or complications that can arise from diabetes, and 13% in all-cause hospitalizations among people with type 2 diabetes not on intensive insulin therapy. "These late-breaking data suggest significant cost-savings associated with use of the FreeStyle Libre technology, which is priced at a third of the cost of other CGMs, by lowering costly diabetes-related complications and hospitalizations," the company added.

14:23 EDT Medtronic shares study results on extended wear infusion set - Medtronic announced data on its extended wear infusion set presented at the virtual 80th Scientific Sessions of the American Diabetes Association. Infusion sets allow people on insulin pump therapy to deliver insulin under the skin to maintain healthy blood glucose levels. Current generation infusion sets must be changed every two to three days. The research revealed that Medtronic Extended infusion sets last twice as long as standard infusion sets with study results suggesting they could provide safe and comfortable wear for patients using Medtronic insulin pumps. "It is the only infusion set in the industry with the ability to be used for up to 7 days and adds to the portfolio of technology offerings from Medtronic which aim to reduce burden and enhance user experience," the company said. The Medtronic Extended infusion set has received CE Mark, and a U.S. pivotal trial to study the safety and effectiveness is currently underway. Clinical studies on multiple infusion set platforms demonstrated that the Medtronic Extended infusion set is safe and effective for up to 7 days, more than twice as long as current Medtronic three-day infusion sets. Using proprietary technology, this new infusion set aims to extend patient wear time by maintaining insulin stability and using new adhesive technology. The breakthrough of longer infusion set wear is achieved through a novel and proprietary approach that addresses insulin degradation and preservative loss which result in infusion set occlusion and consequent hyperglycemia. Details shared on the innovative technology included how insulin stability contributes to infusion site performance and occlusions as well as the methodology used to ensure that the adhesive patch will comfortably last for the duration of wear. Additional analysis has revealed that patients may save between 5-10 vials of insulin per year that is currently thrown away in 3-day set changes.

14:12 EDT Halozyme announces findings from Janssen's Phase 3 Andromeda study - Halozyme Therapeutics announced that Janssen Research & Development presented data from its Phase III ANDROMEDA study of subcutaneous daratumumab utilizing ENHANZE in combination with cyclophosphamide, bortezomib and dexamethasone for patients with newly diagnosed light-chain amyloidosis at the 25th Annual Congress of the European Hematology Association. Janssen reported that the study met the primary endpoint of percentage of patients with hematologic complete response.

14:08 EDT American Express receives clearance to process local transactions in China - American Express announced that its joint-venture in mainland China, Express Technology Services Company, has received approval from the People's Bank of China for a network clearing license. With this, American Express becomes the first foreign payments network to be licensed to clear RMB transactions in mainland China. The company expects to begin processing transactions later this year. Express Company is American Express' joint venture with Lianlian DigiTech, a Chinese fintech services company.

13:41 EDT Roche announces results for Venclexta combination in Acute Myeloid Leukemia - Genentech, a member of the Roche (RHHBY) announced positive results from the Phase III VIALE-A study, evaluating Venclexta in combination with azacitidine in people with previously untreated acute myeloid leukemia who were ineligible for intensive induction chemotherapy. Results from the VIALE-A study showed that the Venclexta combination reduced the risk of death by 34% compared to azacitidine alone in people with previously untreated AML. The Venclexta plus azacitidine combination also led to higher rates of composite complete remission at 66.4% compared to 28.3% with azacitidine alone. Safety for Venclexta plus azacitidine appeared consistent with the known safety profile of these medicines and no unexpected safety signals were identified with the combination. Notable Grade 3 or higher adverse events in the Venclexta plus azacitidine and azacitidine alone arms included low platelet count, low white blood cell count, low white blood cell count with fever and low red blood cell count. The study also met its secondary endpoint of CR and CR with partial hematologic recovery, with the combination showing a CR + CRh of 64.7% compared to 22.8% with azacitidine alone. Data from the VIALE-A study has been shared with health authorities globally including the U.S. Food and Drug Administration. Venclexta has previously been granted accelerated approval by the FDA in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of people with newly diagnosed AML who are aged 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies. VIALE-A is part of Venclexta's ongoing development program to convert the current accelerated approval of Venclexta, granted by the FDA in previously untreated AML, to a full approval. Venclexta has also been granted five Breakthrough Therapy Designations by the FDA, including two for previously untreated AML. Venclexta is being developed by AbbVie (ABBV) and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.

13:32 EDT Match Group, Bumble settle litigation - Match Group and Bumble announced the two companies have reached an agreement to settle all litigations between the two companies. Additional details of the settlement are not being disclosed.