Stockwinners Market Radar for April 03, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:09 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. Tesla (TSLA) has notified workers and suppliers that production at its Shanghai factory will not resume on Monday as it had hoped, according to an internal notice shared with Reuters. Reuters reported earlier on Sunday that the U.S. automaker aimed to resume production on Monday, citing two sources, as it expected to see its first batch of workers released from a lockdown the city imposed to combat a surge in COVID-19 cases. 2. The union that Amazon.com (AMZN) workers recently voted to represent them has demanded the company start bargaining in early May and cease any changes to employment terms at their warehouse in the interim, according to a letter the group issued Saturday on Twitter. The Amazon Labor Union also demanded the retailer respect workers' rights to union representation during disciplinary meetings, according to Reuters. 3. Micron Technology (MU) gets no respect on Wall Street as investors tend to think of Micron, and memory chip makers generally, as providers of interchangeable commodity parts, tech's version of wheat or frozen orange juice, Eric J. Savitz writes in this week's edition of Barron's. The result is that Micron trades at low multiples of sales and earnings relative to other chip makers, the broad market, or any other comparable measure. And that seems shortsighted, the author argues. 4. Sony's (SONY) "Morbius" won this weekend's domestic box office with a $39.1M debut from 4,268 theaters. Globally, Jared Leto's new movie took in $84M. "Morbius" holds just a 17% rating on Rotten Tomatoes from critics and a C+ CinemaScore. 5. Starry Group Holdings (STRY), Texas Pacific Land (TPL), Air Products and Chemicals (APD) and KKR (KKR) saw positive mentions in this week's edition of Barron's.

16:04 EDT Esperion announces two NEXLETOL data presentations at ACC 2022 - Esperion presented two new analyses from its clinical development program of bempedoic acid - NEXLETOL - at the American College of Cardiology's 71st Annual Scientific Session & Expo. The first analysis was titled, "Safety and Efficacy of Bempedoic Acid in Patients with Renal Impairment." This analysis of a total of 3,619 patients included in four Phase 3 studies demonstrated that bempedoic acid 180 mg significantly lowered low-density lipoprotein cholesterol regardless of renal function. While patients with severe renal impairment or end-stage renal disease receiving dialysis were not recruited for these trials, bempedoic acid was effective and generally well tolerated in the large group of patients with Stage 2 or Stage 3 renal impairment. A second analysis was titled, "Safety and Efficacy of Bempedoic Acid in Patients with Hypertension." In 3,623 patients with ASCVD included in pooled data from four Phase 3 studies, 78% had a history of hypertension. In these patients, bempedoic acid 180 mg significantly lowered LDL-C. Bempedoic acid was associated with substantial decreases in LDL-C (pless than0.0001) regardless of a patient's hypertension history. The presentation included an analysis of a Phase 2 study of patients with hypertension, where a significant reduction in LDL-C was found among patients with blood pressure greater than or equal to140/90 and less than or equal to180/110 mmHg.

10:38 EDT Bristol-Myers announces results from Phase 3 VALOR-HCM study - Bristol Myers Squibb announced results from the Phase 3 VALOR-HCM study, which showed the addition of mavacamten, an investigational, first-in-class cardiac myosin inhibitor, significantly reduced the need for septal reduction therapy in patients with severely symptomatic obstructive hypertrophic cardiomyopathy who had been appropriate for SRT per the 2011 American College of Cardiology/American Heart Association Guidelines at baseline. Study participants were on maximally tolerated background regimens when they entered the trial and remained on them through the duration of the study. These data were presented today as a late-breaking clinical trial at the American College of Cardiology's 71st Annual Scientific Session. At 16 weeks the primary and all secondary endpoints were met. Of patients treated with mavacamten, 82% had not proceeded with SRT and no longer met the criteria for SRT according to the 2011 ACC/AHA Guidelines compared to 23% of patients receiving placebo. Patients in the mavacamten arm also demonstrated reduction in left ventricular outflow tract gradients, improvement in New York Heart Association Classification, improvement in quality-of-life measures and improvement in cardiac biomarkers at a high degree of statistical significance compared to the placebo arm. No new safety signals were observed. The composite percentage of patients who proceeded with SRT before or after Week 16 and those who remained eligible for SRT was significantly lower in those taking mavacamten than those receiving placebo. Post-exercise LVOT peak gradient significantly decreased in patients treated with mavacamten vs placebo. The proportion of patients who improved greater than or equal to1 NYHA Class was significantly greater with mavacamten vs placebo. On the patient-reported 23-item Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, average scores of symptom frequency, symptom burden and physical limitation significantly improved in patients treated with mavacamten vs placebo. Improvement in biomarkers of cardiac wall stress and myocardial injury with mavacamten treatment over placebo showed reduction in N-terminal pro brain natriuretic peptide that was 67% greater and reduction in cardiac troponin I that was 47% greater. Safety data show no subjects permanently discontinuing therapy due to left ventricular ejection fraction less than or equal to30% and no subjects experiencing serious adverse events of congestive heart failure, syncope or sudden cardiac death. Two subjects transiently experienced LVEF less than50% and resumed treatment on a lower dose after a short interruption. In the Phase 3 study, patients with symptomatic obstructive HCM who met the 2011 ACC/AHA Guideline criteria and were referred for SRT were randomized 1:1 to mavacamten or placebo for 16 weeks. Study participants remained consistent on their maximally tolerated baseline standard of care regimens, which included ss-blockers, calcium channel blockers and/or disopyramide administered as monotherapy or in combination. Echocardiograms were conducted to evaluate LVOT gradient and LVEF at baseline and during drug titration to guide dosing and assess safety at Weeks 4, 8 and 12. Change from baseline in SRT eligibility, post-exercise LVOT peak gradient, NYHA Class, KCCQ-23 CSS and biomarkers were analyzed at Week 16. Eligibility for SRT was determined based on NYHA Class III or Class IV and LVOT gradient greater than or equal to 50 mmHg at rest or with exertion from Valsalva or exercise, or NYHA Class II with exertional symptoms of syncope or near syncope and elevated gradients. NYHA Classification ranges from I to IV, with Class I showing no symptoms and Class IV exhibiting symptoms at rest.1 The KCCQ-23 CCS is the average score of patient-reported clinical symptoms, including the frequency and burden of lower extremity swelling, fatigue and dyspnea as well as physical limitations, including, but not limited to, dressing, showering, walking and yardwork.2 Scores are based on a scale of 0 to 100, with a change of 5 points considered clinically important and greater than or equal to10 to 20 points considered a moderate-to-large improvement.

10:29 EDT Amylyx presents safety, tolerability data on AMX0035 from clinical trials - Amylyx Pharmaceuticals announced the presentation of safety and tolerability data on AMX0035 as assessed in the CENTAUR and PEGASUS clinical trials in participants with amyotrophic lateral sclerosis and Alzheimer's disease, respectively. The data support the overall safety profile of AMX0035 as findings from this analysis show adverse event incidence was generally similar between AMX0035 and placebo groups in both sets of trial participants. In the CENTAUR trial participants completing the 24-week randomized phase were eligible to enroll in an open-label extension phase and receive AMX0035. PEGASUS was a 24-week randomized trial in adults with AD or mild cognitive impairment. Evaluation of AMX0035's safety and tolerability was the primary objective of both trials. Results of the summary of the clinical trials showed that: The majority of TEAEs associated with AMX0035 were gastrointestinal, consistent with the observed individual safety profiles of the components of AMX0035. In both trials, diarrhea and, to a lesser extent, abdominal discomfort/pain, abdominal distension, and dyspepsia were more frequent with AMX0035 versus placebo. No new safety signals were identified. While the majority of participants in the phase 2 studies experienced TEAEs, they were largely non-serious, mild or moderate in intensity, and assessed as unrelated to treatment with study medication. Findings in AD further elucidated the safety profile of AMX0035, as TEAEs in the CENTAUR trial appear to have been largely disease driven. Further comparison of the TEAEs across both trials suggests that the higher overall incidence of TEAEs in the CENTAUR trial was attributable to symptoms of natural ALS progression, namely muscular weakness and falls, which were among the most common TEAEs in CENTAUR.

10:22 EDT Lexicon announces results of new analysis data from SCORED Phase 3 trial - Lexicon Pharmaceuticals announced results of a new analysis of data from the SCORED Phase 3 clinical trial of sotagliflozin that was presented at the American College of Cardiology's 71st Annual Scientific Session. The SCORED clinical trial randomized 10,584 patients with type 2 diabetes and chronic kidney disease to sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, or placebo. Treatment with sotagliflozin resulted in a significant reduction in major adverse cardiovascular events of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in the entire cohort as compared to placebo. This analysis also evaluated the effect of sotagliflozin on MACE in prespecified subgroups of patients with cardiovascular disease and without CVD at baseline. The analysis showed consistent reductions in MACE in both subgroups with a relative risk reduction in MACE of 21% in patients with and 26% in patients without CVD, in each case compared to placebo.

10:09 EDT BridgeBio presents updated results from Phase 2 OLE study of acoramidis - BridgeBio Pharma announced updated data from its ongoing Phase 2 open-label extension study of acoramidis in patients with symptomatic transthyretin amyloid cardiomyopathy. An interim analysis of the ongoing Phase 2 OLE study was completed based on available data through August 31, 2021. This corresponds to a median of 38 months since Phase 2 enrollment in the first half of 2018 and 35 months of continuous acoramidis treatment in the OLE. Acoramidis was generally well-tolerated and resulted in sustained, near-complete TTR stabilization as measured by established ex vivo assays and increased serum TTR levels. Median N-terminal Pro-brain natriuretic peptide was stable or improving in trial participants throughout the OLE. In ATTR-CM patients, NT-ProBNP concentrations are strongly correlated with mortality and typically increase progressively in untreated patients. The Phase 2 OLE data continue to suggest long-term tolerability of acoramidis in ATTR-CM patients and a stabilization of disease progression in treated participants. The ongoing OLE study enrolled 47 participants who had completed the 28-day randomized, placebo-controlled Phase 2 study of acoramidis in ATTR-CM patients with New York Heart Association class II or III symptoms. Participants received 800 mg of acoramidis hydrochloride twice daily during the OLE. An interim analysis of the ongoing Phase 2 OLE study was completed based on available data through August 31, 2021. BridgeBio's Phase 3 study investigating acoramidis in ATTR-CM is ongoing with Month 30 topline data expected in mid-2023. In the Month 12 readout, no benefit of acoramidis relative to placebo was observed on the six-minute walk test, but improvements in the Kansas City Cardiomyopathy Questionnaire Overall Score, NT-proBNP, and serum TTR level were observed. The Company remains optimistic in the Month 30 primary endpoint, a hierarchical composite including all-cause mortality and cardiovascular hospitalizations.

10:00 EDT Cytokinetics announces METEORIC-HF results, GALACTIC-HF additional data - Cytokinetics announced that the full results from METEORIC-HF - Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure, a Phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction, were presented at the American College of Cardiology 71st Annual Scientific Session. Additional data from GALACTIC-HF - Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure - were also presented including a healthcare resource utilization analysis and an analysis of the effect of treatment with omecamtiv mecarbil in hospitalized patients compared to outpatients. METEORIC-HF evaluated the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment in patients with HFrEF receiving standard of care therapy. The trial enrolled 276 patients in 9 countries. At baseline, patients had an average left ventricular ejection fraction of 27% and an average peak oxygen uptake of 14.7 ml/kg/min; 79% were New York Heart Association Functional Class II. After 20 weeks of treatment, there was no change in pVO2 in patients treated with omecamtiv mecarbil versus placebo. Patients treated with omecamtiv mecarbil had an average change from baseline in pVO2 of -0.2 ml/kg/min compared to 0.2 ml/kg/min for patients on placebo. There was no beneficial effect observed in any of the secondary endpoints, including change in total workload during exercise, change in ventilatory efficiency and change in daily physical activity. Adverse events, including major cardiac events, were similar between the treatment arms, even with patients reaching peak exercise. GALACTIC-HF: Treatment with Omecamtiv Mecarbil Led to 19% Cost Reduction Per Patient Among Patient Subgroup with Ejection Fraction Less than 30%, Without Atrial Fibrillation and Digoxin. In this analysis, a subgroup of 5,369 patients of the 8,256 patients enrolled in GALACTIC-HF met the specific criteria selected. The excluded patient subgroup comprised those who had atrial fibrillation and were taking digoxin or had an ejection fraction greater than 30%. In the selected subgroup, omecamtiv mecarbil was associated with significant reductions in risk of a first heart failure event, total HF events, and cumulative heart failure events. In this selected subgroup of 5,369 patients, treatment with omecamtiv mecarbil also significantly reduced resource intensity, measured by total days in hospital among patients being hospitalized. The estimated potential cost reductions within the selected subgroup related to heart failure events were $3,085, a 19% reduction per patient. Of the cost reductions, 99% were due to heart failure hospitalizations avoided by those patients in GALACTIC-HF who were treated with omecamtiv mecarbil. GALACTIC-HF: Treatment with Omecamtiv Mecarbil Associated with Similar Risk Reduction in the Primary Composite Endpoint in Both Hospitalized Patients and Outpatients. GALACTIC-HF was designed to enroll 25% of patients during hospitalization for worsening heart failure. Of 8,232 patients enrolled, 2,084 were hospitalized at the time of randomization, while 6,148 were randomized as outpatients. At baseline, compared with outpatients, hospitalized patients had higher NYHA Functional Class, were more likely to have atrial fibrillation, had lower systolic blood pressure, and had higher resting heart rate, more severe renal impairment, and higher NT-proBNP. The rate of the primary outcome was higher in hospitalized patients in the placebo group. There was a stepwise gradient in risk, with those randomized as outpatients in the placebo group within 3 months of a heart failure event at the highest risk as compared with those 9-12 months post-event with an adjusted hazard ratio of 1.20. The effect of omecamtiv mecarbil versus placebo on the primary outcome was similar in hospitalized patients and outpatients, indicating that omecamtiv mecarbil similarly reduced the risk of the primary outcome both when initiated in hospitalized patients and in outpatients. In both hospitalized patients and outpatients, the initiation of omecamtiv mecarbil was safe and well tolerated. Treatment-emergent serious adverse events occurred more frequently in patients randomized during hospitalization but did not differ significantly between the treatment groups.