Stockwinners Market Radar for August 30, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:15 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. The head of the U.S. Food and Drug Administration promised that the review of a potential COVID-19 vaccine in the U.S. will be transparent to the public, with any clearance by the agency driven by data alone, Bloomberg's Drew Armstrong reported. In an interview on Sunday, Commissioner Stephen Hahn responded to questions about the different ways the FDA could clear a vaccine for use: either under an emergency authorization, likely based on more limited data and for use in a narrow group, or a broader approval that could lead to wider use. No decision on that has been made, because the agency hasn't seen trial results yet, he said. Pfizer (PFE) and Moderna (MRNA) are among those developing a COVID vaccine. 2. United Airlines (UAL) announced that it is permanently getting rid of change fees on all standard Economy and Premium cabin tickets for travel within the U.S., effective immediately. And starting on January 1, 2021, any United customer can fly standby for free on a flight departing the day of their travel regardless of the type of ticket or class of service, a first among U.S. carriers, while MileagePlus Premier members can confirm a seat on a different flight on the same day with the same departure and arrival cities as their original ticket if a seat in the same ticket fare class is available. United is also extending its waiver for new tickets issued through December 31, 2020, to permit unlimited changes with no fee. This policy applies to all ticket types issued after March 3, 2020 and is valid for domestic and international travel. 3. Home-buyer interest has soared, fueled by demographic trends, ultralow interest rates, and urban flight spurred by the coronavirus pandemic, Shaina Mishkin wrote in this week's edition of Barron's. At the same time, a tighter-than-usual supply of existing homes and chronic underbuilding of new homes has led to bidding wars, rising prices, and a run-up in home-builder stocks, the author noted. Shares of D.R. Horton (DHI) have risen nearly 40% this year, as have shares of Lennar (LEN), while Meritage Homes (MTH) has seen its stock rocket more than 60%. PulteGroup (PHM) is up only 18%, but trades for a rich 2.1 times book value, or the liquidation value of its assets, one valuation metric favored by industry analysts, the report added. All of these stocks could keep climbing as housing demand grows, Mishkin argues, but luxury-home builder Toll Brothers (TOL) and Taylor Morrison Home (TMHC) look like better bets in the near-term. 4. Plans to quickly finalize a deal between the Chinese parent company of TikTok and suitors for the app's U.S. operations have been thrown off track as the parties huddled to weigh new Chinese restrictions that appear designed to affect a potential sale, The Wall Street Journal's Georgia Wells and Cara Lombardo reported, citing people familiar with the matter. China late on Friday issued new restrictions on the export of artificial-intelligence technology that forced ByteDance, TikTok's parent, to slow down talks with companies including Microsoft (MSFT), Walmart (WMT) and Oracle (ORCL) for a portion of the social media app, sources said. 5. Magna International (MGA), Starbucks (SBUX), McDonald's (MCD), Vornado Realty Trust (VNO), SL Green Realty (SLG), and Empire State Realty Trust (ESRT) saw positive mentions in this week's edition of Barron's.

16:36 EDT MyoKardia presents results from Phase 2 EXPLORER-HCM trial of Mavacamten - MyoKardia announced that 30-week results from its pivotal Phase 3 EXPLORER-HCM clinical trial of mavacamten for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy were presented during a live Hot Line session at the European Society of Cardiology Congress 2020. Results from the EXPLORER-HCM study were simultaneously published in The Lancet. MyoKardia previously announced topline data from the EXPLORER-HCM study showing that patients treated with mavacamten experienced statistically significant and clinically meaningful improvements in symptoms, functional status and key aspects of quality of life. In addition to meeting the primary and all secondary endpoints, mavacamten was well tolerated with a safety profile similar to placebo. The data presented and reported in the published manuscript also include mavacamten's positive impact on reducing cardiac biomarkers associated with poor prognosis and demonstrate the consistency of its therapeutic benefit across multiple prespecified subgroups. The randomized, controlled, pivotal EXPLORER-HCM Phase 3 clinical trial enrolled 251 symptomatic, obstructive patients with HCM, most of whom were on standard background HCM therapy. Among the new data presented today, mavacamten treatment was shown to markedly reduce key biomarkers of cardiac wall stress and injury in a pronounced and clinically meaningful way. Serum concentrations of N-terminal pro B-type natriuretic peptide from baseline to Week 30 were reduced by 80%, to near normal levels, in the mavacamten treatment group relative to placebo. NT-proBNP is a well-established biomarker of cardiac wall stress that has been associated with increased mortality in HCM patients. The decrease in NT-proBNP was observed at the earliest timepoint measured and was sustained throughout the 30-week treatment period. Similarly, reductions in cardiac troponin from baseline to Week 30 were 41% greater in the mavacamten-treated cohort compared to placebo. Cardiac troponin I is closely associated with increased incidence of heart failure, atrial fibrillation and death in patients with HCM. As previously reported, mavacamten demonstrated a robust treatment effect in the Phase 3 study. The primary endpoint, a composite functional analysis designed to capture the treatment effect of mavacamten relative to placebo on both symptoms and cardiac function, was met with statistical significance. Additionally, mavacamten demonstrated beneficial results for all secondary endpoints. Data presented and published in The Lancet reveal that mavacamten's benefit versus placebo for the primary and all secondary endpoints extended across all prespecified subgroups. Specifically, the reduction in obstruction and the improvements in exercise capacity and clinician and patient assessments favoring mavacamten over placebo were highly consistent regardless of age, gender, genetic status, body mass index, background use of beta blockers, or baseline measures of ejection fraction, NYHA class and NT-proBNP. Mavacamten was well tolerated and demonstrated safety results similar to placebo, with no new findings observed from those previously reported. Ninety-seven percent of patients enrolled completed the study treatment period. Overall rates of adverse events, serious adverse events, and cardiac adverse events, including atrial fibrillation, were comparable for patients treated with mavacamten and placebo. Mavacamten was granted breakthrough therapy designation from the U.S. Food and Drug Administration in July 2020. MyoKardia plans to submit a New Drug Application for mavacamten to the U.S. Food and Drug Administration in the first quarter of 2021.

16:28 EDT Mirum Pharmaceuticals presents Maralixibat 5-year transplant-free survival data - Mirum Pharmaceuticals presented an analysis from its Phase 2 INDIGO study in an oral late-breaker session at the Digital International Liver Congress 2020. The five-year analysis showed that patients with PFIC2, also known as bile salt export pump deficiency, who achieved sBA control on long-term maralixibat treatment have a significant improvement in transplant-free survival. In February 2020, the NAPPED consortium published an analysis showing that surgical interruption of the enterohepatic circulation of bile acids can lead to transplant-free survival when sBAs are reduced by 75% or below 102 micromol/L. Data presented this weekend demonstrate that, similar to the findings of NAPPED, patients exhibiting sBA control with pharmacological interruption of the enterohepatic circulation with maralixibat have significantly improved transplant-free survival. Seven of the 19 non-truncating patients with PFIC2 achieved this response threshold. In addition, the data showed that maralixibat responders achieved improvement across numerous parameters including quality of life scores, normalization of liver enzyme and bilirubin levels if abnormal at baseline, decreased pruritus and accelerated growth. Long-term treatment with maralixibat was well-tolerated. The most frequent treatment-emergent adverse events were nasopharyngitis, vomiting, cough, diarrhea, pyrexia and abdominal pain. The majority of TEAEs were mild to moderate in severity and transient.

16:21 EDT Bluebird Bio presents data from Phase 2/3 Starbeam, Phase 3 ALD-104 studies - Bluebird bio announced updated results from the clinical development program for its investigational elivaldogene autotemcel gene therapy in patients with cerebral adrenoleukodystrophy, including long-term results from the Phase 2/3 Starbeam study and data from the Phase 3 ALD-104 study. These data were presented today at the 46th Annual Meeting of the European Society for Blood and Marrow Transplantation. The Starbeam Study, ALD-102, study has completed enrollment. All reported data are as of January 2020 and reflect a total population of 32 patients with a median follow-up time of 30.0 months. Of the 32 patients who have received eli-cel as of January 2020, 20 have completed ALD-102 and enrolled in a long-term follow-up study, or LTF-304. Nine additional patients continue to be followed in ALD-102 and have not reached 24 months post-treatment. As previously reported, two patients withdrew from the study at investigator discretion, and one experienced rapid disease progression early on-study resulting in MFDs and death. To date, 104.3 patient-years of follow-up have been reported for ALD-102 and LTF-304. The primary efficacy endpoint in the study is the proportion of patients who are alive and free of MFDs at Month 24. Of those patients who have or would have reached Month 24, 87% have met the primary endpoint and continue to be alive and MFD-free at more than two years of follow-up. Fourteen patients have at least four years of follow-up, including 10 patients who have reached at least their Year 5 follow-up visit. The nine patients from ALD-102 that have not reached Month 24 have shown no evidence of MFDs. Data on several secondary and exploratory efficacy outcomes are reported, including changes in neurologic function score, a 25-point score used to evaluate the severity of gross neurologic dysfunction across 15 symptoms in six categories; resolution of gadolinium enhancement, an indicator of active inflammation in the brain; and change in Loes score, an MRI measurement of white matter changes in CALD. Of the 32 patients treated, 31 had stable NFS following treatment with eli-cel, defined as NFS less than4, without a change of greater than 3 from baseline, and 24 patients maintained an NFS of 0. An NFS of 0 indicates that there are no concerns with the neurologic functions that are assessed on the 25-point scale. Loes scores generally stabilized within 12-24 months and GdE was no longer seen in most patients following eli-cel treatment. The primary safety endpoint is the proportion of patients who experience acute or chronic GvHD by Month 24. GvHD is a condition that may occur after an allo-HSCT, where the donated cells view the recipient's body as foreign and attack the body. No events of acute or chronic GvHD have been reported post-eli-cel treatment. There have been no reports of graft failure or graft rejection. In addition, there have been no cases of replication competent lentivirus or insertional oncogenesis to date. Integration site analysis was conducted to determine the pattern of integration post-eli-cel infusion and assess whether dominant or expanding clones were present. In one patient, now enrolled in LTF-304 for long-term follow up, a case of benign clonal expansion was observed with three separate integrations in the DNA of the cell at ACER3, RFX3, and MECOM. As of the patient's Month 62 visit in March 2020, the patient remained clinically stable. Bone marrow analyses showed no dysplasia or molecular abnormalities. The treatment regimen, comprising mobilization/apheresis, conditioning, and eli-cel infusion, had a safety and tolerability profile primarily reflective of the known effects of mobilization/apheresis and conditioning. In ALD-102, as previously reported, three adverse events were considered possibly related to drug product and include one serious AE, BK viral cystitis, and two non-serious AEs, vomiting. All three AEs resolved using standard measures. Bluebird bio is currently enrolling patients for ALD-104, a Phase 3 study designed to assess the efficacy and safety of eli-cel in patients with CALD after myeloablative conditioning using busulfan and fludarabine, a different chemotherapy conditioning regimen than what is used in ALD-102. The primary efficacy endpoint is the proportion of patients who are alive and free of MFDs at Month 24, and the primary safety endpoint is the proportion of patients with neutrophil engraftment after eli-cel infusion. All reported data are as of February 2020. In ALD-104, the 13 patients currently on study have a median of 6.1 months of follow-up to date. All 13 patients achieved neutrophil engraftment and 12/13 evaluable patients had platelet engraftment. No events of acute or chronic GvHD have been reported and there have been no reports of graft failure, graft rejection, cases of insertional oncogenesis, or replication competent lentivirus. The treatment regimen, comprising mobilization/apheresis, conditioning, and eli-cel infusion had a safety and tolerability profile primarily reflective of the known effects of mobilization/apheresis and conditioning. In ALD-104, two AEs of pancytopenia were considered possibly related to eli-cel. These two ongoing AEs were deemed as suspected unexpected serious adverse reactions by the principal investigator and were diagnosed approximately two months post-eli-cel infusion in two patients. An additional AE was ongoing as of February 2020, a Grade 3 SAE of transverse myelitis that was diagnosed in the presence of viral infection approximately six months after eli-cel infusion and deemed unrelated to eli-cel.

16:09 EDT Amgen announces data from Phase 3B study of Repatha - Amgen announced positive data from the HAUSER-RCT Phase 3b study evaluating the safety and efficacy of Repatha in pediatric patients, 10-17 years of age, with heterozygous familial hypercholesterolemia. The study showed that Repatha, in combination with statins and other lipid-lowering therapies, significantly reduced low-density lipoprotein cholesterol compared to placebo. These data was presented during an oral presentation at ESC 2020 - The Digital Experience, organized by the European Society of Cardiology, and simultaneously published in The New England Journal of Medicine. Results from the randomized, double-blind 24-week study show that in pediatric patients with HeFH, monthly treatment with Repatha reduced LDL-C by mean 38.3% from baseline compared to placebo, and absolute reduction in LDL-C was 68.6 mg/dL meeting its primary endpoint and showing superiority of evolocumab administered on top of statins. Patients treated with Repatha had improved secondary lipid parameters from baseline in comparison to placebo, including a 42.1% reduction in mean LDL-C from weeks 22-24, a 35.0% reduction in non-high-density lipoprotein cholesterol at week 24, a 32.5% reduction in apolipoprotein B at week 24, and 36.4% reduction in ApoB/apolipoprotein A1 ratio at week 24.5 No new safety risks were identified. The most common treatment-emergent adverse events proportionally higher in the Repatha group compared with placebo were headache, oropharyngeal pain, influenza, influenza-type illness, upper respiratory tract infection and constipation.

16:01 EDT Akcea Therapeutics presents data from Phase 2 study of AKCEA-APOCIII-LRx - Akcea Therapeutics (AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, and Ionis Pharmaceuticals, (IONS), presented data today from the Phase 2 study of AKCEA-APOCIII-LRx in an online Late Breaking Clinical Trial Session at the ESC Congress 2020, the annual meeting of the European Society of Cardiology. Results showed that AKCEA-APOCIII-LRx met primary and key secondary endpoints with significant reductions in triglyceride and apoC-III levels, and a favorable safety and tolerability profile in the treatment of patients with hypertriglyceridemia who have established cardiovascular disease or are at risk for CVD. AKCEA-APOCIII-LRx is designed using Ionis' proprietary Ligand Conjugated Antisense technology platform to inhibit production of apolipoprotein C-III, a protein produced in the liver that plays a central role in the regulation of serum triglycerides. Epidemiological studies show that apoC-III levels may help predict risk of CVD. The Phase 2 study was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study designed to evaluate the safety, tolerability and efficacy of AKCEA-APOCIII-LRx in patients with hypertriglyceridemia and a clinical diagnosis of CVD or who are at high risk of CVD. The study was also designed to identify the optimal dose and dose regimen to lower TG, apoC-III and other lipid and lipoprotein levels for subsequent Phase 3 studies. The study involved 114 patients randomized to four cohorts and in a 4:1 ratio within each cohort. AKCEA-APOCIII-LRx or placebo was administered via subcutaneous injection for at least six months, with some patients treated up to a year. Weekly, bi-weekly, and monthly dosing regimens were explored with total monthly doses ranging from 10 mg to 50 mg.

15:53 EDT Amarin announces results from EVAPORATE study at ESC Congress 2020 - Amarin announced trial results from Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy. Final results of the EVAPORATE Trial were presented at ESC Congress 2020, the annual meeting of the European Society of Cardiology. VASCEPA, or icosapent ethyl, demonstrated significant, 17% regression of low attenuation plaque volume on multidetector computed tomography compared with placebo over 18 months. A total of 80 patients were enrolled in the randomized, double-blind, placebo-controlled EVAPORATE trial. Patients had to have coronary atherosclerosis as documented by MDCT, be on statin therapy, and have persistently elevated triglyceride levels. Patients underwent an interim scan at 9 months and a final scan at 18 months. The prespecified primary endpoint was a comparison of change in LAP volume at 18 months between icosapent ethyl and placebo. EVAPORATE was not powered for long-term outcomes. According to the company, the final results showed a significant reduction in the primary endpoint; icosapent ethyl reduced LAP plaque volume by 17% from baseline to the 18-month scan, whereas there was a progression of LAP plaque volume in the placebo group. There were significant differences between icosapent ethyl and placebo at study end for secondary endpoints of other types of plaque volume changes, including and sequentially total, total non-calcified, fibrofatty, and fibrous plaque volumes. All regressed in the icosapent ethyl group and progressed in the placebo group. The only secondary endpoint which did not achieve a significant difference between groups in multivariable modeling was dense calcium. The mineral oil placebo, used for consistency with REDUCE-IT, was also analyzed against plaque changes from baseline in another placebo in a separate study. Rates of plaque changes in patients randomized to mineral oil in the EVAPORATE study were compared with rates of plaque changes in the placebo arm of a second study that used a cellulose-based placebo. There was no difference in plaque progression between mineral oil and cellulose based placebos. Limitations of this single study include a small sample size. More study is needed to demonstrate the effects of VASCEPA on coronary plaque to determine the relationship of such effects, if any, on cardiovascular risk reduction, Amarin noted.

10:00 EDT Natural Grocers falls -8.9% - Natural Grocers is down -8.9%, or -$1.19 to $12.11.

10:00 EDT Plantronics falls -13.3% - Plantronics is down -13.3%, or -$1.95 to $12.74.

10:00 EDT Contura Energy rises 12.8% - Contura Energy is up 12.8%, or 49c to $4.33.