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19:32 EDT Downdetector shows Instagram down for thousands of users - Instagram was down for thousands of users on Sunday, according to Downdetector.com. Over 180,000 users reported issues with accessing Meta Platform's Instagram. Reference Link

16:35 EDT Regeneron, Sanofi present Dupixent late-breaking Phase 3 COPD results - Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) presented "positive" Phase 3 results evaluating the investigational use of Dupixent, or dupilumab, compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled chronic obstructive pulmonary disease, or COPD, and evidence of type 2 inflammation. The Dupixent Phase 3 results were presented in the 2023 American Thoracic Society International Conference session "New England Journal of Medicine and JAMA. The results presented at ATS and published in NEJM are from the BOREAS trial, which met the primary and all key secondary endpoints. As presented and published, patients receiving Dupixent compared to placebo added to maximal standard-of-care inhaled triple therapy experienced a: 30% reduction in moderate or severe acute COPD exacerbations over 52 weeks, the primary endpoint. 160 mL improvement in lung function from baseline at 12 weeks versus 77 mL. Numerical improvements were observed as early as 2 weeks, with the benefit versus placebo sustained through 52 weeks. 9.7-point improvement in health-related quality of life from baseline at 52 weeks versus a 6.4-point improvement, with numerical improvements observed as early as 4 weeks. 2.7-point reduction in respiratory symptom severity from baseline at 52 weeks versus a 1.6-point reduction. In a pre-specified analysis from a subgroup of patients with elevated levels of fractional exhaled nitric oxide - an airway biomarker of type 2 inflammation - Dupixent treatment also led to a significant 38% reduction in exacerbations compared to placebo at 52 weeks. In this subgroup, Dupixent also led to an improvement in lung function of 232 mL versus 108 mL for placebo at 12 weeks that was sustained at 52 weeks with an improvement in lung function of 247 mL versus 120 mL for placebo. The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Overall rates of adverse events were 77% for Dupixent and 76% for placebo. AEs leading to deaths were balanced between the two arms. The second, replicate Phase 3 trial of Dupixent in COPD with evidence of type 2 inflammation is ongoing, with data expected in 2024. The safety and efficacy of Dupixent in COPD are currently under clinical investigation and have not been evaluated by any regulatory authority.

08:40 EDT Boston Scientific presents data at Hearth Rhythm 2023 - Boston Scientific announced data supporting use of the company's key electrophysiology and cardiac rhythm management therapies, and the WATCHMAN FLX Left Atrial Appendage Closure Device. All data were presented at Heart Rhythm 2023, the annual meeting of the Heart Rhythm Society, held in New Orleans from May 19-21. Real-world outcomes from the multi-center EU-PORIA registry were highlighted in a late-breaking data presentation, further demonstrating the safety, efficacy and learning curve characteristics of the FARAPULSE PFA System. The registry data included favorable single procedure success rates, along with efficient procedure times in a broad patient population. More than 1,200 patients with paroxysmal or persistent atrial fibrillation were enrolled and treated at seven high-volume European centers. Key findings from the registry: Rates of freedom from recurrence of AF and atrial tachycardia were high at 74.0% per the Kaplan-Meier estimate at a median follow-up of one year. The freedom from recurrence rate was 80.0% in patients with paroxysmal AF and 66.0% in patients with persistent AF. Level of physician experience with AF ablation did not impact procedure times or patient outcomes, reinforcing the procedural reproducibility of the FARAPULSE PFA System. Data demonstrated a predictable workflow with a median of 58 minutes within an interquartile range of 40 to 87 minutes. There was a 1.7% major complication rate and 1.9% minor complication rate with no reported esophageal damage or pulmonary vein stenosis and a single case of sustained phrenic nerve palsy, which was reported in the MANIFEST PF study. Results from the global, prospective, non-randomized, single-arm FROZEN-AF IDE study of the POLARx Cryoablation System met the safety and effectiveness endpoints of the trial. The study, which examined use of the device for the treatment of patients with paroxysmal, or intermittent atrial fibrillation, included an extension arm for the POLARx FIT Cryoballoon Catheter, a single device capable of enabling 28 and 31mm sizes. The extension arm sub-study also achieved its safety and effectiveness endpoints and included 50 patients who were treated with at least one application of the 31mm cryoballoon and will be followed for 12 months. At the time of data release, patients had undergone six out of a total of 12 months of follow up. Key findings from the trial: The primary safety endpoint of composite acute and chronic primary safety events through 12 months was achieved with an event-free rate of 96.3% at 12 months in the IDE trial and 100% at six months in the extension arm of the study. There were no reports of moderate or severe pulmonary vein stenosis, persistent phrenic nerve palsy or esophageal fistulas in either patient cohort. The rate of freedom from documented atrial arrhythmias was 79.9% at 12 months in the IDE trial and 88.0% at six months in the extension arm. Effects of the EMBLEM MRI Subcutaneous Implantable Defibrillator on tricuspid regurgitation Data from a secondary analysis of the investigator-sponsored, randomized ATLAS trial compared among nearly 450 patients the severity of tricuspid regurgitation at six months following the implantation of a transvenous implantable cardioverter-defibrillator versus the EMBLEM MRI S-ICD. Tricuspid regurgitation is a disease that occurs when the tricuspid valve does not close properly and is a risk factor for heart failure. Key findings from the analysis: At six months, patients in the TV-ICD group were seven times more likely to have worsening tricuspid regurgitation. Of those with worsening tricuspid regurgitation, moderate or severe symptoms developed in 6.9% of patients receiving a TV-ICD versus 2.3% of those receiving an S-ICD. Hybrid strategy for secondary prevention of sudden cardiac death using ventricular tachycardia (VT) ablation and the EMBLEM MRI S-ICD The prospective, investigator-sponsored VTabl-SICD trial explored among 32 patients the safety and efficacy of a novel hybrid management strategy combining VT ablation with S-ICD implantation in patients who have scar-related VT. Findings from the study suggested that the combination strategy was superior to conventional TV-ICD implantation for the secondary prevention of sudden cardiac death by significantly reducing the need to deliver ICD therapy and avoiding untreated, symptomatic arrhythmias. At two years, the rate of delivery of any appropriate ICD therapy was significantly lower in the VTabl-S-ICD group compared to the TV-ICD group. There were no cases of untreated symptomatic VT or ventricular fibrillation in the VTabl-S-ICD group. Data presented from two new sub-analyses of the SURPASS study out of the National Cardiovascular Data RegistryLAAO Registry provided insights into real-world treatment strategies with the WATCHMAN FLX LAAC Device. The first analysis assessed outcomes with different post-procedural antithrombotic therapies and demonstrated that patients treated with direct oral anticoagulants alone had the lowest risk of major adverse events in comparison to other drug regimens following the implant. The second analysis demonstrated that concomitant catheter ablation and LAAC with the WATCHMAN FLX device was safe and had similar outcomes when compared to device implantation alone. In addition, the latest preclinical data for the investigational WATCHMAN FLX Pro LAAC Device demonstrated that its new thromboresistant coating may further reduce the risk of device-related thrombus and result in faster and more uniform tissue coverage on the device at 45 days post implant.

08:32 EDT Alnylam presents 18-Month results from APOLLO-B Phase 3 study of patisiran - Alnylam Pharmaceuticals announced new results from an interim analysis of exploratory data from the open-label extension period of the APOLLO-B Phase 3 study of patisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated amyloidosis with cardiomyopathy. The results were presented at the Annual Congress of the Heart Failure Association of the European Society of Cardiology. The company previously announced that APOLLO-B achieved its primary endpoint and met its first secondary endpoint during the 12-month double-blind period and that it has submitted the 18-month data to the U.S. Food and Drug Administration as an amendment to the supplemental New Drug Application for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis. The 18-month findings indicate that the favorable effects on functional capacity and health status and quality of life, as measured by the 6-Minute Walk Test and the Kansas City Cardiomyopathy Questionnaire Overall Summary, respectively, observed during the DB period were sustained with continued patisiran treatment during the OLE period. Patients treated with patisiran through 18 months also appear to have maintained relative stability of NT-proBNP and Troponin I levels, measures of cardiac stress and injury, respectively. Patients who crossed over from placebo in the DB period to patisiran during the OLE period appear to show slowing of disease progression or relative stabilization across these same endpoints at Month 18. While the APOLLO-B study was not designed to show benefits in cardiac outcomes between patisiran and placebo, evidence of favorable, but non-statistically significant, trends were observed for composite all-cause death and hospitalization, and mortality analyses across the DB and OLE periods.

08:19 EDT Abbott unveils late-breaking results from AVEIR DR i2i IDE study - Abbott announced late-breaking results from the AVEIR dual-chamber, or DR, i2i Investigational Device Exemption, or IDE, study, a large-scale study to assess the world's first dual-chamber leadless pacemaker, showing that the leadless pacemaker met its three prespecified primary endpoints for safety and performance. The data further suggests that AVEIR DR could offer new benefits for people with slower-than-normal heart rhythms. The results are being presented during a late-breaking clinical trial session at the Heart Rhythm Society's 44th annual meeting in New Orleans, and simultaneously published in The New England Journal of Medicine. The data has been provided to the U.S. Food and Drug Administration as part of Abbott's submission for approval of the AVEIR DR device. Under the AVEIR DR i2i IDE study, primary safety and efficacy endpoints were analyzed in the first 300 people enrolled across 55 centers in the United States, Canada and Europe. The design goals of AVEIR DR1 include technologies to regulate the heart rate synchronously and continuously between both chambers that enable true dual-chamber leadless pacing. Results of the AVEIR DR i2i IDE study through three-months post-implant showed: Physicians demonstrated a 98.3% implant success rate. Safety endpoint evaluating freedom from device or procedure complications was achieved. More than 97% of people had successful atrio-ventricular synchrony, so that the upper and lower chambers were beating normally, despite different types of underlying slow heart rhythms. The average AV synchrony was more than 95% in each of seven different posture and walking speeds, demonstrating the system will function appropriately during everyday life activities.