Stockwinners Market Radar for June 27, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:21 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. Johnson & Johnson (JNJ) and its U.S.-based Janssen Pharmaceutical Companies announced a settlement agreement with the State of New York and its participating subdivisions, including Nassau County and Suffolk County, resolving their opioid-related claims against the company. With this agreement, the company is removed from the trial scheduled to begin in Suffolk County on June 28, J&J stated. The settlement will provide New York and its participating subdivisions with up to $263M in funding to address opioid related issues, as well as reimbursement for attorney fees and costs. 2. Brookfield Business Partners (BBU) together with institutional partners announced an agreement to acquire Modulaire Group for approximately $5 billion. Brookfield's investment will be funded with approximately $1.6 billion of equity. Brookfield Business Partners intends to fund approximately $500 million, with the balance being funded by institutional partners. Prior to or following closing, a portion of Brookfield Business Partners' commitment may be syndicated to other institutional investors. Closing of the transaction remains subject to customary closing conditions including regulatory approvals. Closing is expected by the end of 2021. 3. Investors are waiting for more consumers to return and worry about the risks created by a shortage of workers, with those concerns weighing on shares of Olive Garden parent Darden Restaurants (DRI), whose stock dropped 12% from March 26 through June 18, Ben Levisohn wrote in this week's edition of Barron's. They may have been overblown, the author contended. The risks are still there-commodity prices are rising, and labor costs are rising even faster-but the company should have the ability to raise prices to compensate, the author argued, adding that Darden also said that it expects there to be 10% fewer restaurants than before the pandemic, which means it could gain market share. 4. Comcast (CMCSA) subsidiary Universal's "F9" won this weekend's box office with a $70M debut, a pandemic-era record for North America and the biggest domestic opening since "Star Wars: The Rise of Skywalker" in December 2019. Globally, the ninth installment in the Fast and Furious saga crossed $400M. 5. Chart Industries (GTLS), Hertz Global Holdings (HTZGQ), NMI Holdings (NMIH), Essent Group (ESNT) and MGIC Investment (MTG) saw positive mentions in this week's edition of Barron's.

18:06 EDT Tandem Diabetes presents real-world data from t:slim X2 insulin pump use - Tandem Diabetes presented positive real-world data from ongoing use of the t:slim X2 insulin pump with Control-IQ advanced hybrid closed-loop technology, demonstrating statistically significant improvements in glycemic and patient-reported outcomes. Emphasis was placed on qualitative experiences as well as insights from diverse populations using the system. The data was presented this week during the 81st Scientific Sessions of the American Diabetes Association. The presentation reported outcomes from the ongoing Control-IQ Observational study evaluating real-world use of the t:slim X2 insulin pump with Control-IQ technology in diverse groups of people with type 1 diabetes. At baseline, Black participants reported the highest HbA1c compared to participants from other ethnic cohorts. Using Control-IQ technology, Glucose Management Indicator at 21 days reflected significant glycemic improvements across all ethnic groups with Asian participants showing the lowest GMI followed by Caucasian participants. At 21 days, the median sensor time in range of Black participants was significantly lower than for Caucasian participants while controlling for age, gender, reported exercise, annual income, and prior therapy. Baseline HbA1c was the key factor predicting sensor TIR, followed by exercise, annual income, and multiple daily injections. Disparities in glycemic outcomes across socioeconomic and demographic groups recorded at baseline remained after initiating an automated insulin dosing system. However, Control-IQ technology significantly improved glycemic outcomes for all ethnic groups. Another presentation reported insulin use on the t:slim X2 pump with Control-IQ technology from the ongoing CLIO Study evaluating real-world use of the t:slim X2 insulin pump with Control-IQ technology in a large, diverse cohort with type 1 diabetes. Study sample included 1,499 participants who had uploaded at least 21 days of pump data to Tandem's t:connect web application and had 75% CGM use during this time. Insulin delivery during the study was compared to standard formulas for predicting correction factor and carbohydrate ratio. Results demonstrated that insulin use with the t:slim X2 pump with Control-IQ technology differed from standard prediction formulas across age groups, in that the correction factor prediction factor was significantly greater in children and teenagers. CFPF was lowest in children aged 6-9 and in adults aged 66 and above. Additional study is recommended, with comparison to final glycemic outcomes, to determine ideal insulin delivery settings with Automated Insulin Dosing, as examination of insulin use patterns may assist in optimizing outcomes. An additional presentation reported results from qualitative analyses of semi-structured interviews conducted with adult early adopters of Control-IQ technology to understand their experiences of initiating and continued use of this technology. Improved sleep quality, glycemic control, and sensor time in range were common themes reported by participants along with reduced burden of diabetes management. Overall, participants described valuable improvements in their quality of life, including reduced stress and decision-making around diabetes management, and increased freedom and spontaneity in daily life with continued use of Control-IQ technology. Another presentation examined retrospective analysis of real-world glycemic outcomes by previous therapy between people with type 1 and type 2 diabetes over a period of six months after they onboarded to Control-IQ technology. After 180 days of starting Control-IQ technology, for prior pump users with type 1 diabetes, sensor TIR was 74% and time below less than70mg/dL was 1.2%. For prior pump users with type 2 diabetes, sensor TIR was 76% and time below less than70mg/dL was 0.5%. For participants transitioning from MDI, Control-IQ technology resulted in sensor TIR of 74% and 0.9% time below less than70mg/dL for people with type 1 diabetes and 74% TIR and 0.3% time below less than70mg/dL for people with type 2 diabetes. Using Control-IQ technology, both type 1 and type 2 diabetes participants achieved the recommended sensor TIR and time below less than70mg/dL outcomes.

16:11 EDT Lilly's SURPASS-1 results show superior A1C, body weight reductions vs. placebo - Tirzepatide led to superior A1C and body weight reductions from baseline across all three doses in adults with type 2 diabetes after 40 weeks of treatment in Eli Lilly's SURPASS-1 monotherapy clinical trial evaluating the efficacy and safety of tirzepatide compared to placebo. Detailed SURPASS-1 results were presented in an oral presentation during the American Diabetes Association's 81st Scientific Sessions, were simultaneously published in The Lancet and will be featured during an ADA-sponsored symposium on Tuesday, June 29. Study participants in SURPASS-1, 54.2 percent of whom were treatment-naive, had a relatively short mean duration of diabetes of 4.7 years, a baseline A1C of 7.9 percent and a baseline weight of 85.9 kg. For the efficacy estimandi, tirzepatide reduced A1C by up to 2.07 percent and body weight by up to 9.5 kg compared to placebo. Up to 52 percent of participants achieved an A1C less than 5.7 percent - the level seen in people without diabetes. Tirzepatide also led to improvements in the change in fasting serum glucose from baseline. In an additional secondary endpoint, tirzepatide led to improvements in the change in two-hour post-meal glucose values from baseline from self-monitored blood glucose data. The overall safety profile of tirzepatide was similar to the well-established glucagon-like peptide-1 receptor agonist class, with gastrointestinal side effects being the most commonly reported adverse events. Treatment discontinuation rates due to adverse events were less than 7 percent in each tirzepatide treatment arm. For both estimandsii, all three tirzepatide doses reached statistical significance in A1C and body weight reductions from baseline and in the percentage of participants who achieved an A1C of less than 7 percent or less than 5.7 percent. At 40 weeks, tirzepatide led to a significant decrease in fasting serum glucose compared to placebo. In an additional secondary endpoint, the mean two-hour post-meal glucose values for tirzepatide across all three doses were under 140 mg/dL. In an additional exploratory endpoint, all three doses of tirzepatide led to favorable changes from baseline in fasting lipids. The most commonly reported adverse events for tirzepatide were gastrointestinal-related and mostly mild to moderate in severity, usually occurring during the dose escalation period. SURPASS-1 is the first of five global registration studies for tirzepatide in type 2 diabetes, all of which have been completed. Lilly intends to submit the full registration package to regulatory authorities by the end of 2021.

16:04 EDT Intellia, Regeneron announce interim data from Phase 1 study of NTLA-2001 - Intellia Therapeutics (NTLA) and Regeneron Pharmaceuticals (REGN) announced positive interim data from an ongoing Phase 1 clinical study of their lead in vivo genome editing candidate, NTLA-2001, which is being developed as a single-dose treatment for transthyretin amyloidosis. The Phase 1 study, run by Intellia as the program's development and commercialization lead, is evaluating NTLA-2001 in people living with hereditary transthyretin amyloidosis with polyneuropathy. NTLA-2001 is the first CRISPR/Cas9-based therapy candidate to be administered systemically, via intravenous infusion, for precision editing of a gene in a target tissue in humans. NTLA-2001 is designed to inactivate the TTR gene in liver cells to prevent the production of misfolded transthyretin protein, which accumulates in tissues throughout the body and causes the debilitating and often fatal complications of ATTR amyloidosis. The interim data were presented at the 2021 Peripheral Nerve Society Annual Meeting and published in The New England Journal of Medicine. The interim data released cover the first six ATTRv-PN patients across two single-ascending dose cohorts of the Phase 1 study, which is currently being conducted in the United Kingdom and New Zealand. Single doses of either 0.1 mg/kg or 0.3 mg/kg of NTLA-2001 were administered systemically. Reductions in serum TTR levels were measured from baseline to day 28. Treatment with NTLA-2001 led to dose-dependent reductions in serum TTR, with mean reductions of 52% among the three patients in the 0.1 mg/kg dose group, and 87% among the three patients in the 0.3 mg/kg dose group, including one patient with a 96% reduction. By contrast, the standard of care for ATTRv-PN, which requires chronic treatment, typically yields TTR reductions of approximately 80%. At both dose levels, NTLA-2001 was generally well-tolerated by the six patients included in the interim analysis, with no serious adverse events and no liver findings by day 28. Given the safety and tolerability profile so far, NTLA-2001 is continuing to be evaluated in the dose-escalation portion of the study, to determine if a higher dose could result in a deeper reduction in disease-causing protein levels leading to the potential for more meaningful clinical benefit. As of the date of this release, Cohort 3, evaluating NTLA-2001 at the 1 mg/kg dose level, is actively enrolling. Following the identification of a recommended dose in the dose-escalation portion of the study, Intellia expects to begin a single-dose expansion cohort in Part 2 of the Phase 1 trial later this year. After completion of the Phase 1 trial, the company plans to move to pivotal studies for both polyneuropathy and cardiomyopathy manifestations of ATTR amyloidosis. Intellia intends to present additional data from the study at a medical or scientific meeting later this year.

15:53 EDT Arbutus Biopharma announces new data on AB-729, AB-836 programs - Arbutus Biopharma announced the presentation of five abstracts at the European Association for the Study of the Liver International Liver CongressTM. According to the presentations, AB-729 continues to demonstrate robust mean HBsAg reduction across all doses and dosing intervals with a favorable safety and tolerability profile, followed by a sustained plateau phase. William Collier, President and Chief Executive Officer of Arbutus, stated, "Given our focus and commitment to the development of a cure for people living with HBV, we are gratified that all of our abstracts were selected for presentation at the Best of ILCTM. In the second half of 2021, we look forward to the initiation of two Phase 2a proof of concept AB-729 clinical trials and to reporting initial data from both healthy volunteers and HBV subjects in our AB-836 Phase 1a/1b clinical trial. With the extensive amount of AB-729 data presented by Arbutus to date, we are confident that it has the potential to be a cornerstone drug in future HBV combination regimens."