Stockwinners Market Radar for June 11, 2017 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:36 EDT Microsoft unveils Xbox One X videogame console - Microsoft (MSFT) unveiled the Xbox One X videogame console during its press conference Sunday at the "E3" videogame trade show. The product, previously code-named Project Scorpio, is "the world's most powerful console" and will launch in all Xbox One markets beginning November 7 for $499. All Xbox One games and accessories are compatible with the new console. "Xbox One X was created to deliver uncompromised power, ultimate compatibility and design excellence. It's both the most powerful and smallest console Xbox has ever built," the company commented. Other publicly traded companies in the space include Sony (SNE) and Nintendo (NTDOY).

17:14 EDT Novartis receives Orphan designation for neuroendocrine tumor candidate - The FDA has granted Orphan designation for Novartis' "humanized monoclonal antibody against human PD-1" in the treatment of neuroendocrine tumors. The designation was granted June 8, according to an online notice from the agency. Reference Link

16:14 EDT vTv Therapeutics reports Phase 2 data on TTP273 in diabetes - vTv Therapeutics announced that results from a Phase 2 clinical study of TTP273, an investigational, oral small molecule GLP-1 receptor agonist for the treatment of Type 2 diabetes, were presented at the American Diabetes Association annual meeting. Researchers from vTv reviewed results from a concentration/effect analysis on the LOGRA study showing that lower doses of TTP273 "may show more pronounced effects for key efficacy endpoints," including a reduction in HbA1c, weight and fasting plasma glucose. "The characteristics of TTP273 -- functionally biased and neuro-endocrine signaling -- provide a potential scientific rationale supporting the concept that for TTP273, less may be more... Further analysis of the Phase 2 data has highlighted a trend where a lower dose shows more pronounced effects," the company added. TTP273 was well tolerated with no severe hypoglycemia adverse events. The most common TEAE was diarrhea, mostly mild in intensity, with only one subject discontinued due to mild diarrhea. Less nausea was observed in active groups than placebo and the only incidence of vomiting occurred with placebo dosing. Once daily dosing of TTP273 demonstrated placebo-subtracted decrease from baseline of 0.9% in HbA1c and 0.9 kg in weight.

15:21 EDT Regeneron, Sanofi say two studies of Praluent meet primary goals - Regeneron (REGN) and Sanofi (SNY) announced Sunday "positive" results from two Phase 3b/4 ODYSSEY-DM trials in patients with diabetes. In the studies, Praluent when administered on top of maximally tolerated doses of statins significantly reduced low-density lipoprotein cholesterol, the primary endpoint of the ODYSSEY-DM INSULIN study, and was superior to usual care in reducing non-high-density lipoprotein cholesterol, the primary endpoint of the ODYSSEY-DM DYSLIPIDEMIA study. Both studies also found that a majority of patients reached their lipid goals with Praluent 75 mg every two weeks, with an overall safety profile comparable to the ODYSSEY Phase 3 program. The results were unveiled as part of the American Diabetes Association annual meeting. Specifically, in ODYSSEY-DM INSULIN, approximately 80 percent of patients reached their LDL-C goals with Praluent 75 mg every two weeks in this study. Praluent in combination with MTD statins reduced LDL-C by 48.2 percent from baseline compared to a 0.8 percent increase for placebo. The mean difference between the two treatment arms was -49 percent. Treatment with Praluent also improved the overall lipid profile. Treatment emergent adverse events were similar between the two groups and no emerging safety findings were identified from the study. The most frequent TEAEs included nasopharyngitis, myalgia, arthralgia and cough. There was no new safety signal with the concomitant use of Praluent and insulin. There was no impact on glycemic control as assessed by fasting plasma glucose, A1C and glucose lowering treatments remained stable over time in both treatment groups. In ODYSSEY-DM DYSLIPIDEMIA, approximately 64 percent of patients reached their lipid goals with the Praluent 75 mg dose. Praluent was superior to usual care in lowering non-HDL-C, at 37.3 percent and 4.7 percent, for the usual care arm. The mean difference between the two treatment arms was 32.5 percent. Praluent in combination with MTD statins reduced LDL-C by 43.3 percent from baseline compared to a 0.3 percent increase for usual care. Treatment with Praluent also improved the overall lipid profile. Praluent was generally well-tolerated. There was no impact on glycemic control observed as assessed by fasting plasma glucose, A1C and glucose lowering treatments remained stable over time in both treatment groups.

15:04 EDT Mylan: Data confirms efficacy, safety of MYL-1501D - Mylan and Biocon announced Saturday the presentation of new data from the insulin glargine clinical program, including the INSTRIDE studies at the American Diabetes Association's annual meeting. The studies "confirmed the efficacy, safety and immunogenicity" of MYL-1501D, insulin glargine, in comparison to Lantus in patients with Type 1 and Type 2 diabetes, the company said. Data demonstrating pharmacokinetic and pharmacodynamic equivalence also was presented. "We are pleased with the positive results of the INSTRIDE clinical program, which demonstrate comparable clinical efficacy and safety of our insulin glargine to Lantus," said Mylan.

14:52 EDT Sanofi reports data from real-world 'DELIVER 3' study - Sanofi announced Saturday new evidence from a real-world observational study demonstrating "significantly" less risk of documented hypoglycemia with similar blood sugar control after switching to Toujeo compared to switching to another basal insulin including Lantus, Levemir and Tresiba, in an at-risk population of senior adults with type 2 diabetes. The results of the DELIVER 3 retrospective observational study comparing two cohorts were presented at the American Diabetes Association annual meeting. In the DELIVER 3 study, patients switching to Toujeo were 57 percent less likely to experience hypoglycemia at 6-month follow-up than those who switched to another basal insulin, with similar glycemic control -- least squares mean difference -0.09%. These findings are "broadly consistent" with Toujeo evidence from DELIVER 2, the company noted. Sanofi noted in its announcement that initial results from its ACHIEVE CONTROL, REACH CONTROL and REGAIN CONTROL studies are anticipated "later in 2017."

14:45 EDT Zafgen reports two data sets on ZGN-1061 - Zafgen announced Saturday the presentation of new data for ZGN-1061, its second-generation MetAP2 inhibitor, in two posters at the American Diabetes Association's scientific sessions. The data show ZGN-1061 treatment causes improvements across multiple metabolic measures consistent with MetAP2 inhibition, demonstrates rapid drug absorption and clearance, and has a "favorable" safety profile with no evidence of prothrombotic effects, the company said. The first poster details the full results from the Phase 1 clinical trial of ZGN-1061, including new efficacy data related to secondary endpoints. As previously reported, on average, patients treated with ZGN-1061 for four weeks lost weight relative to placebo: -4.6 lbs, -2.2 lbs, and -3.8 lbs for 0.2 mg, 0.6 mg, and 1.8 mg vs. -0.51 lbs for placebo. Body weight loss was steady and progressive during treatment with ZGN-1061 and rebounded post-treatment. ZGN-1061 produced improvements in waist circumference relative to placebo. In addition, treatment with ZGN-1061 resulted in a trend for reduced food intake. The clinical trial demonstrated trends for reductions in LDL-cholesterol, and high-sensitivity C-reactive protein. Notably, there were greater reductions in mean LDL-cholesterol and hsCRP in ZGN-1061-treated subjects with abnormally elevated LDL or hsCRP at baseline. The clinical trial also showed a trend for reductions in leptin and increases in adiponectin with ZGN-1061 compared to placebo, "reflective of favorable changes in adipose function and signaling." ZGN-1061 is rapidly metabolized and cleared following administration, with a much shorter half-life than beloranib. Single and repeat doses of ZGN-1061 were generally safe and well tolerated. There were no severe adverse events, no serious AEs, and no AEs leading to early withdrawal from the clinical trial. As previously reported, there was no prothrombotic effect observed with ZGN-1061. No treatment emergent venous thromboembolisms, no clinically meaningful D-dimer elevations indicative of thrombosis and no elevations in mean D-dimer levels were observed in the dosing groups compared to baseline or placebo. There were no clinically significant changes in coagulation laboratory parameters or other key biomarkers of interest, including von Willebrand factor and soluble thrombomodulin. "We advance toward initiating our Phase 2 clinical trial in patients with type 2 diabetes who are obese, in the second half of 2017," the company noted. The second poster featured preclinical data demonstrating that ZGN-1061 showed similar effects on diabetes, obesity, and other metabolic endpoints, but with a greatly improved safety profile in comparison to the company's prior development compound, beloranib. Highlights include: ZGN-1061 showed statistically significant improvements in glycemic control, insulin sensitivity, body weight, body fat, lipids and cardiometabolic biomarkers compared to vehicle, and these improvements were comparable to those seen for beloranib. ZGN-1061 is rapidly metabolized and cleared following administration, with a much shorter half-life than beloranib. ZGN-1061 displays a reduced impact on endothelial cells compared to beloranib, and on several thrombotic markers, including P21, thrombomodulin, and plasminogen activator inhibitor-1, in vitro, as well as thrombin time and D-dimer in vivo. ZGN-1061 has improved safety margins for morbidity and coagulopathy, with a 200-fold margin for ZGN-1061 compared to approximately 4-fold for a clinically equivalent dose of beloranib.

14:20 EDT Merck, Pfizer say Phase 3 diabetes studies meet primary goals - Merck (MRK) in partnership with Pfizer (PFE) announced Saturday that two Phase 3 studies -- VERTIS MET and VERTIS SITA -- of ertugliflozin, an oral SGLT-2 inhibitor in development to help improve glycemic control in adults with type 2 diabetes, met their primary endpoints. Both doses of ertugliflozin tested achieved statistically significant reductions in A1C, a measure of blood glucose, when added to metformin or in initial co-administration with sitagliptin. The results of these studies, along with 52-week extension data from three other studies in the VERTIS clinical development program of ertugliflozin, will be presented at the scientific sessions of the American Diabetes Association. VERTIS MET showed patients taking ertugliflozin 5 mg or 15 mg and metformin experienced greater reductions in A1C compared to placebo -- 0.7 percent and 0.9 percent, respectively, compared with 0.0 percent for placebo. Ertugliflozin in combination with metformin also met a secondary endpoint in the study, as significantly more patients taking either ertugliflozin 5 mg or 15 mg achieved the ADA's recommended A1C treatment goal of less than 7 percent compared with placebo and metformin. As add-on therapy to metformin, treatment with ertugliflozin also resulted in significant reductions in fasting plasma glucose, body weight, systolic blood pressure and diastolic blood pressure, compared with placebo. VERTIS SITA showed that patients taking ertugliflozin 5 mg or 15 mg, in combination with sitagliptin 100 mg, experienced greater reductions in A1C compared with patients taking placebo alone -- 1.6 percent and 1.7 percent, respectively, compared with 0.4 percent. Additionally, the co-administration of ertugliflozin and sitagliptin met a secondary endpoint in the study, as significantly more patients taking ertugliflozin 5 mg or 15 mg, in combination with sitagliptin 100 mg, achieved the A1C treatment goal of less than 7 percent. Treatment with the initial combination of ertugliflozin and sitagliptin also resulted in significant reductions in FPG, body weight and SBP, compared with placebo.

14:07 EDT CooperVision says three-year study shows benefit of contact lens product - Cooper Companies subsidiary CooperVision announced Saturday that "a pioneering contact lens therapy has considerable potential to impact the rising prevalence of myopia in children, according to highly-anticipated study outcomes presented today at the British Contact Lens Association Clinical Conference." At the conference, CooperVision reviewed three-year results from the clinical trial assessing a specially-designed, dual-focus myopia control 1-day soft contact lens in reducing the rate of progression of juvenile-onset myopia. Three-year findings indicated that use of the dual-focus contact lens was effective in slowing myopia progression 59% as measured by mean cycloplegic spherical equivalent and 52% as measured by mean axial elongation of the eye when compared to the children in the control group wearing a single vision 1-day contact lens. Three-year results indicated the dual focus lens was well accepted by children, and did not affect their daily activities. Children in both the test and control groups had a higher satisfaction with contact lenses over spectacles. Parents of study participants also had a very positive response, noting their children could mostly manage their lens wear independently. "No other prospective randomized controlled study has offered conclusive data for such a high degree of continued efficacy in myopia management using a 1-day soft contact lens over three years," the company remarked.

13:57 EDT Alibaba Cloud to open data centers in India, Indonesia - Alibaba Cloud, the cloud computing arm of Alibaba Group, announced Friday that it plans to establish two new data centers in Mumbai, India and Jakarta, Indonesia, and currently anticipates opening the two new IDCs during the current fiscal year, ending on March 31, 2018. "Together with the recently announced data center in Malaysia, Alibaba Cloud will significantly increase its computing resources in Asia, allowing greater support for small and medium enterprises throughout the region," the company remarked. With the three new data centers planned, Alibaba Cloud will increase its total number of data center locations to 17.