Stockwinners Market Radar for June 09, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:21 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. Raytheon (RTN) and United Technologies (UTX) have entered into an agreement to combine in an all-stock merger of equals. The combined company will be named Raytheon Technologies Corporation, and will exclude Otis and Carrier, which are expected to be separated from United Technologies in the first half of 2020 as previously announced. The combined company will have approximately $74B in pro forma 2019 sales. Under the terms of the agreement, which was unanimously approved by the Boards of Directors of both companies, Raytheon share owners will receive 2.3348 shares in the combined company for each Raytheon share. Upon completion of the merger, United Technologies shareowners will own approximately 57% and Raytheon shareowners will own approximately 43% of the combined company on a fully diluted basis. The merger is expected to close in the first half of 2020, following completion by United Technologies of the previously announced separation of its Otis and Carrier businesses. 2. Group of 20 finance ministers have agreed to compile common rules to close loopholes used by global tech giants such as Facebook (FB) to reduce their corporate taxes, Reuters' Stanley White and Jan Strupczewski reported. Facebook, Google (GOOG; GOOGL), Amazon (AMZN) and other large technology companies face criticism for reducing their tax bills by booking profits in low-tax countries regardless of the location of the end customer, the authors noted. 3. Falling interest rates and a threatening economic slowdown bode ill for U.S. banks, and their stocks have fallen out of favor, but there are some compelling reasons to embrace the banks, especially JPMorgan (JPM), Andrew Bary wrote in this week's edition of Barron's. The company's strengths are underappreciated, with shares trading for 11 times projected 2019 earnings of $10 a share and yield almost 3%, the author noted, adding that the bank is expected to boost its quarterly payout to about 90c. 4. Comcast (CMCSA) subsidiary Universal's "The Secret Life of Pets 2" won the weekend's North American box office, earning $47.1M in its debut from 4,561 locations. The animated family film received a 54% rating on Rotten Tomatoes and an A- CinemaScore. "The Secret Life of Pets 2" is the tenth team-up for animation studio illumination and Universal. 5. Alibaba (BABA), Tencent (TCEHY) and British Land (BTLCY) saw positive mentions in this week's edition of Barron's, while Uber (UBER) was mentioned cautiously.

18:57 EDT Tandem reports results from studies of t:slim X2 insulin pump with Control-IQ - Tandem Diabetes announced results from two studies of the t:slim X2 insulin pump with Control-IQ advanced hybrid closed-loop technology. Data from both studies demonstrated that the system achieved the primary outcome of increasing time in range without any severe hypoglycemic events. The t:slim X2 insulin pump with Control-IQ technology utilizes Dexcom G6 continuous glucose monitoring sensor values to predict glucose levels and adjust insulin delivery to prevent highs and lows, while still allowing the user to manually bolus for meals. The system also automates correction boluses, which is a feature not commercially available today on automated insulin delivery devices. Details from the two studies, which included Protocol 3 of the National Institutes of Health-funded International Diabetes Closed Loop trial and interim data from the Freelife Kid AP study, were presented at the 79th Scientific Sessions of the American Diabetes Association. The NIH-funded DCLP3 study is the first large-scale, 6-month closed-loop study that included a dedicated control group, increasing the clinical significance of the study results. There were no exclusion criteria based on hemoglobin A1c, history of acute complications, or previous experience using an insulin pump or CGM. Following a two to eight-week run-in period, the length of which was determined based on previous pump and CGM experience, 168 patients with type 1 diabetes ages 14 and up were randomized 2:1 to Control-IQ technology or sensor-augmented pump therapy and followed for 26 weeks. The entry HbA1c for participants in the study ranged from 5.4 to 10.6 with a mean of 7.4%. Approximately 20% of participants were new to pump therapy and the large majority were already using a CGM. All participants completed the study. The Freelife Kid AP study is a multi-center, randomized assessment of the efficacy of closed-loop insulin therapy in prepubertal children, comparing nocturnal and 24-hour use of Control-IQ technology over 18 weeks, followed by an 18-week extension. The completed study, taking place in France, is expected to include 120 participants with type 1 diabetes ages 6 to 12 years old. An interim analysis was planned after 12 weeks from the first 30 included subjects to assess percent of time in closed-loop mode, incidence of any severe adverse events and efficacy measures based on CGM data. The t:slim X2 insulin pump with Control-IQ technology utilizes Dexcom G6 CGM sensor values to predict glucose levels 30 minutes ahead and adjust insulin delivery to help prevent highs and lows, while still allowing the user to manually bolus for meals. The system also automates correction boluses, which is a feature not commercially available today on automated insulin delivery devices.

16:42 EDT Raytheon, United Technologies agree to all-stock merger of equals - Raytheon (RTN) and United Technologies (UTX) have entered into an agreement to combine in an all-stock merger of equals. The combined company will be named Raytheon Technologies Corporation, and will exclude Otis and Carrier, which are expected to be separated from United Technologies in the first half of 2020 as previously announced. The combined company will have approximately $74B in pro forma 2019 sales. Under the terms of the agreement, which was unanimously approved by the Boards of Directors of both companies, Raytheon share owners will receive 2.3348 shares in the combined company for each Raytheon share. Upon completion of the merger, United Technologies shareowners will own approximately 57% and Raytheon shareowners will own approximately 43% of the combined company on a fully diluted basis. The merger is expected to close in the first half of 2020, following completion by United Technologies of the previously announced separation of its Otis and Carrier businesses. The timing of the separation of Otis and Carrier is not expected to be affected by the proposed merger and remains on track for completion in the first half of 2020. The combined company expects to return $18B-$20B of capital to shareowners in the first 36 months following completion of the merger. As a result of the combination, the company also expects to capture more than $1B in gross annual run-rate cost synergies by year four post-close, with approximately $500M in annual savings returned to customers. In addition, the combination presents significant long-term revenue opportunities from technology synergies. Raytheon plans to consolidate its four businesses into two businesses to be named Intelligence, Space & Airborne Systems and Integrated Defense & Missile Systems. The new businesses will join Collins Aerospace and Pratt & Whitney to form the four businesses of Raytheon Technologies. Net debt for the combined company at the time of closing is expected to be approximately $26B, with United Technologies expected to contribute approximately $24B. The combined company targets an 'A' category credit rating at the time of the closing. The combined company's Board of Directors will be comprised of 15 members, consisting of 8 directors from United Technologies and 7 from Raytheon, with the lead director from Raytheon. Tom Kennedy will be appointed Executive Chairman and Greg Hayes will be named CEO of Raytheon Technologies. Two years following the close of the transaction, Hayes will assume the role of Chairman and CEO. There is no change to either Raytheon's or United Technologies' financial outlook for 2019.

16:11 EDT Five Prime announces departure of Sheila Gujrathi From Board of Directors - Five Prime (FPRX) announced the departure of Sheila Gujrathi from the company's board of directors. Gujrathi has served as a board member of Five Prime since December 2015 and is stepping down from the board to focus on her role as President and Chief Executive Officer of Gossamer Bio (GOSS).

13:55 EDT Provention Bio announces results from At Risk study in Type 1 Diabetes - Provention Bio announced that results from the National Institutes of Health-sponsored "At-Risk" Study were published on-line in The New England Journal of Medicine and presented at the Scientific Sessions of the 79th Annual American Diabetes Association meeting. The "At-Risk" Study was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, with additional support from JDRF. The study was conducted by the Type 1 Diabetes TrialNet, an international collaboration aimed at discovering ways to delay or prevent type 1 diabetes, and evaluated Provention's PRV-031 for the prevention or delay of clinical T1D in relatives of type 1 diabetics at high-risk of developing the disease. PRV-031 is an anti-CD3 monoclonal antibody in development for the interception and prevention of clinical T1D. The "At Risk" Study enrolled 76 participants ages 8 to 49 who were "At-Risk" because they had two or more T1D autoantibodies and abnormal glucose metabolism; 72% of participants were under the age of 18. Subjects were randomized to receive either PRV-031 or placebo. Results from the study showed that a single 14-day course of PRV-031 significantly delayed the onset and diagnosis of clinical T1D, as compared to placebo, by a median of 2 years in children and adults considered to be at high risk. The median time to clinical diagnosis of T1D for placebo participants was just over 24 months. In comparison, the median time for PRV-031-treated participants to clinical diagnosis of T1D was just over 48 months. During the trial, 72% in the placebo group developed clinical diabetes compared to only 43% of the PRV-031 group. PRV-031 was well tolerated and the safety data were consistent with prior studies in newly diagnosed patients.

13:37 EDT Eli Lilly's tirzepatide demonstrates benefits in data presented - Results from several studies of Eli Lilly's investigational dual GIP and GLP-1 receptor agonist, tirzepatide, reinforce its potential in lowering A1C and body weight in people with type 2 diabetes. Early research results also support tirzepatide's potential benefit in treating other metabolic conditions. A sub-analysis of phase 2b results show tirzepatide improved markers of beta cell function and insulin sensitivity in people with type 2 diabetes. Improvements in insulin sensitivity markers seen with GLP-1 RAs have been primarily explained by weight loss; therefore, researchers further analyzed these markers to better understand if the GIP action in tirzepatide contributes to a unique profile. Unlike GLP-1 RAs, the improvements seen with tirzepatide were only partially attributed to weight loss, suggesting an independent effect of GIP on insulin sensitivity may contribute to the strong and clinically meaningful blood glucose control seen in the 26-week phase 2b study. Tirzepatide shows consistent positive impact on blood glucose control and weight loss while improving tolerability with dose escalations. Data from a 12-week, phase 2 study showed dose escalations with tirzepatide resulted in fewer gastrointestinal side effects while maintaining the efficacy seen in the phase 2b study. Reduced study discontinuation rates were also observed. To inform optimal dosing for the phase 3 program, researchers evaluated three tirzepatide dose-escalation regimens to determine impact on composite GI side effects and efficacy. Tirzepatide treatment led to significant A1C reductions and weight loss, consistent with the phase 2b study; GI side effects were mild to moderate in intensity and overall lower than in the phase 2b study; treatment discontinuation rates due to adverse events with tirzepatide were less than 5 percent, comparable to placebo and overall lower than in the phase 2b study. Data learned from this and other tirzepatide studies, along with modeling, support that a lower initial dose and smaller incremental dose escalations improve tolerability, which informed the selected dosing approach for the phase 3 clinical trial program - SURPASS - initiated in late 2018. Results from another study - an eight-week trial in Japanese people with type 2 diabetes - showed significant reductions in A1C and body weight after treatment with tirzepatide.3 This study also supports the significant A1C and body weight reductions seen in the phase 2b study, suggesting tirzepatide's potential for effectively treating people with type 2 diabetes is consistent across populations. Given the relationship between NASH and type 2 diabetes, researchers analyzed tirzepatide's impact on several markers associated with NASH. In an analysis of the phase 2b study of people with type 2 diabetes, researchers found that treatment with tirzepatide led to improvements in NASH-related markers. A phase 2b study exploring tirzepatide in NASH will initiate later this year.

13:12 EDT President Trump says U.S. to release more details on Mexico deal - President Donald Trump said via Twitter that, "Another false report in the Failing @nytimes. We have been trying to get some of these Border Actions for a long time, as have other administrations, but were not able to get them, or get them in full, until our signed agreement with Mexico. Additionally, and for many years,... Mexico was not being cooperative on the Border in things we had, or didn't have, and now I have full confidence, especially after speaking to their President yesterday, that they will be very cooperative and want to get the job properly done. Importantly, some things... not mentioned in yesterday press release, one in particular, were agreed upon. That will be announced at the appropriate time. There is now going to be great cooperation between Mexico & the USA, something that didn't exist for decades. However, if for some unknown reason... there is not, we can always go back to our previous, very profitable, position of Tariffs - But I don't believe that will be necessary. The Failing @nytimes, & ratings challenged @CNN, will do anything possible to see our Country fail! They are truly The Enemy of the People!" Reference Link

12:43 EDT Medtronic initiates trial for next-generation Guardian CGM sensor - Medtronic announced that it has initiated the company's pivotal trial for its next-generation Guardian continuous glucose monitoring sensor designed to improve accuracy and overall system performance, reduce sensor calibrations and enhance overall user experience. The multi-center, prospective trial will study the next-generation CGM sensor in up to 460 participants with type 1 or type 2 diabetes aged two to 80 years old over the course of seven days. Study participants will be randomly assigned to sensor wear location and testing days and times.

12:36 EDT Medtronic initiates trial for bluetooth enabled MiniMed 780G AHCL systems - Medtronic announced the enrollment of the first study participants in the company's pivotal trial of its Bluetooth enabled MiniMed 780G advanced hybrid closed loop system, designed to automate the delivery of correction boluses when the user experiences, or is predicted to experience, prolonged high glucose levels based on their sensor readings. The trial will evaluate the safety of the MiniMed 780G system in participants with type 1 diabetes at home, at work, during exercise and other daily activities. The study will enroll up to 350 adult and pediatric participants. Data from the feasibility study demonstrated the safety of the system and its potential to improve overall glycemic control and simplify diabetes management for individuals who forget to administer a bolus of insulin at mealtime, carb count inaccurately or choose to forgo announcing meals. Additionally, hypoglycemia dropped by 27% and hyperglycemia was reduced by 14% with no serious adverse events reported.