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10:17 EDT Amgen announces results from Phase 3B study of Repatha - Amgen announced positive results from the EvolocumaB Effect on LDL-C LowerIng in SubJEcts with Human Immunodeficiency ViRus and INcreased Cardiovascular RisK study evaluating the efficacy and safety of Repatha in patients who are human immunodeficiency virus-positive and have high low-density lipoprotein cholesterol despite stable background lipid-lowering therapy. The study demonstrated that treatment with Repatha significantly reduced LDL-C. Results from the double-blind 24-week study show that in people living with HIV with hypercholesterolemia or mixed dyslipidemia, monthly treatment with Repatha reduced LDL-C by 56.9% from baseline compared to placebo, meeting its primary endpoint.1 Patients treated with Repatha also demonstrated improved secondary outcomes versus placebo with 71.9% of patients achieving an LDL-C reduction of more than or equal to 50% from baseline and 65.4% of patients achieving an LDL-C of less than 70 mg/dL. No new safety concerns were identified in the BEIJERINCK trial. The subject incidence of treatment-emergent adverse events was comparable among both groups. The Phase 3b BEIJERINCK study is part of Amgen's PROFICIO program of clinical and real-world evidence studies investigating the impact of Repatha and examining the use of lipid-lowering therapies across different patient populations. To date, the PROFICIO program consists of 35 clinical trials including more than 41,000 patients worldwide and more than 80 real-world evidence studies.

10:11 EDT Merck presents results from VICTORIA trial evaluating vericiguat - Merck (MRK) announced the presentation of results from the VICTORIA trial, a Phase 3 study evaluating the efficacy and safety of its investigational drug vericiguat, an orally administered soluble guanylate cyclase stimulator being developed to treat patients with heart failure with reduced ejection fraction and following a worsening event. VICTORIA is the first contemporary outcomes study focused exclusively on symptomatic chronic heart failure patients following a worsening event. Vericiguat is being jointly developed with Bayer (BAYRY). Patients enrolled in VICTORIA were at high risk of hospitalization and cardiovascular death following a recent heart failure decompensation. Vericiguat, when given in combination with available heart failure therapies, met the primary efficacy endpoint of reducing the risk for the composite endpoint of heart failure hospitalization or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction, compared to placebo. A hazard ratio of 0.90 in this high risk population translated into a clinically relevant 4.2/100 patient-years absolute reduction in event rate. Based on this absolute risk reduction, the number needed to treat with vericiguat for one year to prevent a primary outcome event is approximately 24 patients. The safety profile of vericiguat was consistent with that reported in previous studies. Merck and Bayer plan to share VICTORIA data with regulatory authorities worldwide.

09:56 EDT Esperion announces data presentations of NEXLETOL, NEXLIZET Tablet - Esperion announced that two pooled analyses from four Phase 3 clinical trials of NEXLETOL and results from the Phase 2 study of NEXLIZET were presented at the American College of Cardiology's 69th Scientific Session Together with World Congress of Cardiology. A poster titled "Bempedoic Acid 180 mg + Ezetimibe 10 mg Fixed Combination Drug Product vs Ezetimibe Alone or Placebo in Patients with Type 2 Diabetes and Hypercholesterolemia" highlighted that in the Phase 2 study, NEXLIZET significantly lowered LDL-Cholesterol by a mean 40% compared to placebo, reduced high-sensitivity C-reactive protein by 25% compared to baseline and resulted in no worsening of glycemic control. The incidence of adverse events rates were generally comparable to placebo. In addition, a poster, titled "Factors Influencing Bempedoic Acid-Mediated Reductions in High-sensitivity C-reactive Protein: Analysis of Pooled Patient-level Data from 4 Phase 3 Clinical Trials" highlighted that in the pooled Phase 3 studies, NEXLETOL significantly lowered hsCRP in patients with hypercholesterolemia regardless of the presence or intensity of background statin therapy. In patients whose hsCRP levels were greater than 2 mg/L at baseline, the analysis showed NEXLETOL significantly reduced this marker of inflammation by 42% at 12 weeks. The third poster was titled "Bempedoic Acid Efficacy and Safety in Patients at High Risk for CVD Treated with or Without Ezetimibe: Pooled Analysis of 4 Phase 3 Clinical Trials" and the pooled analysis showed that in the Phase 3 studies, NEXLETOL provided significant additional LDL-C lowering as well as significantly lowered other lipid endpoints, regardless of the presence of background ezetimibe. Importantly, the safety profile of NEXLETOL was similar with or without background ezetimibe therapy.