Stockwinners Market Radar for September 02, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

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LUV...		Hot Stocks 20:00 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. Elliott Investment Management now holds 10% of Southwest Airlines' (LUV) common stock, crossing the threshold that allows the hedge fund to call a special meeting at the carrier, Reuters' Svea Herbst-Bayliss reports, citing a person familiar with the matter. The news comes days before the two sides are scheduled to meet on Sept. 9 to discuss ways to solve problems that have contributed to Southwest's stock losing roughly half its value over the last three years. 2. Intel (INTC) CEO Pat Gelsinger and key executives are expected to present a plan later this month to the company's board of directors to slice off unnecessary businesses and revamp capital spending, Reuters' Max A. Cherney and Milana Vinn report, citing a source familiar with the matter. The plan will include ideas on how to shave overall costs by selling businesses, including its programmable chip unit Altera, that Intel can no longer afford to fund from the company's once-sizeable profit, the authors write. Gelsinger and other high-ranking executives at Intel are expected to present the plan at a mid-September board meeting, the same source said. 3. DexCom (DXCM) stock blew up after the company mismanaged its investments in new growth opportunities. Shares could be ready to rebound now that the company has introduced a new product, Jacob Sonenshine writes in this week's edition of Barron's. DexCom, which is expected to sell the devices to just under three million people this year, has plenty of growth potential. It even announced this week Stelo, a new CGM for noninsulin Type 2 diabetics and prediabetics, the author adds. 4. Disney (DIS) and Marvel's "Deadpool & Wolverine" won the North American box office in a slow moviegoing weekend, as Labor Day usually is, with most people marking the end of summer with other more outdoorsy activities. For the four-day weekend, the movie grossed about $19.5M in its sixth outing as it crossed the $600M mark domestically, the 16th film in history to do so. 5. Bright Horizons Family Solutions (BFAM), Vertiv Holdings (VRT), Citigroup (C), Goldman Sachs (GS), Dow (DOW), Hasbro (HAS), CarMax (KMX) and Albemarle (ALB) saw positive mentions in this week's edition of Barron's.
MRNA		Hot Stocks 08:50 EDT Taiwan FDA approves Moderna's COVID-19 vaccine for SARS-COV-2 variant JN.1 - Moderna announced that the Taiwan Food & Drug Administration has approved an updated formulation of the COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. In April 2024, the World Health Organization Technical Advisory Group on COVID-19 Vaccine Composition issued guidance recommending the use of a monovalent JN.1 lineage for COVID-19 vaccine antigen composition.
ARWR		Hot Stocks 06:49 EDT Arrowhead presents new pivotal Phase 3 data from PALISADE study of Plozasiran - Arrowhead Pharmaceuticals announced results from the Phase 3 PALISADE study of investigational plozasiran in patients with familial chylomicronemia syndrome, a severe and rare genetic disease which currently has no approved treatments in the U.S. PALISADE successfully met its primary endpoint and all multiplicity-controlled key secondary endpoints, including statistically significant reductions in triglycerides, apolipoprotein C-III, and the incidence of acute pancreatitis. These data were presented today in a late-breaking oral presentation at the European Society of Cardiology Congress 2024 and simultaneously published in The New England Journal of Medicine. Based on these positive findings from the PALISADE study, Arrowhead intends to file a New Drug Application with the United States Food and Drug Administration by year-end 2024 and plans to seek regulatory approval with additional global regulatory authorities thereafter. In PALISADE, 75 patients with persistent chylomicronemia, with or without a genetic diagnosis, were randomly assigned to receive subcutaneous plozasiran at 25 mg or 50 mg or placebo every three months for 12 months. At baseline, the median triglyceride level was 2044 mg/dL. Forty-four patients had genetically confirmed FCS and 31 patients had clinically diagnosed persistent chylomicronemia suggestive of FCS. At month ten, the median reduction from baseline in the fasting triglyceride level was -80% in the 25 mg plozasiran group, -78% in the 50 mg plozasiran group, and -17% in the placebo group. Marked reductions in the median triglyceride level below guideline-directed risk thresholds associated with acute pancreatitis occurred as early as one month after trial initiation and showed modest variation throughout the 12-month blinded treatment period. The mean percentage change in triglyceride level was similar to median values. At month ten, APOC3 was significantly reduced with median reductions of -93% in the 25 mg plozasiran group, -96% in the 50 mg plozasiran group, and -1% in the placebo group. The final alpha-controlled secondary efficacy end point compared the incidence of positively adjudicated acute pancreatitis in a pre-specified pooled analysis of the 25 mg and the 50 mg plozasiran groups versus the pooled placebo group. Among the 38 suspected cases of acute pancreatitis that were referred for adjudication, nine episodes in seven patients were positively adjudicated. Plozasiran demonstrated statistical significance for this endpoint, with patients receiving plozasiran achieving an 83% reduction in the risk of developing acute pancreatitis versus placebo. A total of two cases occurred in two of 50 patients receiving plozasiran, and seven cases occurred in five of 25 patients receiving placebo. Plozasiran demonstrated a favorable safety profile in the PALISADE study.
IRTC...		Hot Stocks 06:33 EDT iRhythm Technologies announces results of GUARD-AF trial - iRhythm Technologies (IRTC) announced the presentation and publication of the GUARD-AF randomized clinical trial at the European Society of Cardiology Congress 2024. The trial was sponsored by Bristol-Myers Squibb (BMY)-Pfizer (PFE) Alliance and iRhythm provided the Zio XT patch ECG long-term continuous monitoring monitor used in the interventional arm of the study. GUARD-AF was a prospective, parallel-group, randomized controlled trial designed to test whether screening for AF in people aged greater than or equal to 70 years using an on-label Zio XT 14-day single-lead LTCM could identify patients with undiagnosed AF and reduce stroke. Participants were randomized 1:1 to screening with Zio XT LTCM or usual care. The primary efficacy and safety outcomes were hospitalization due to all-cause stroke and bleeding, respectively. During a median follow-up of 15 months in 11,905 enrolled patients from 149 primary care sites in the U.S., the study found that Zio XT LTCM led to an increase in new diagnosis of AF vs usual care through the end of follow-up. There was no significant difference between groups in incidence of the primary endpoint of stroke hospitalization, although event rates were low and the trial was stopped before achieving enrollment of the planned total of 52,000 patients during the COVID-19 pandemic, thereby reducing statistical power.
BLTE		Hot Stocks 06:30 EDT Belite Bio announces appointment of Hendrik Scholl as Chief Medical Officer - Belite Bio, a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, announced that its board of directors has appointed Hendrik Scholl as the Chief Medical Officer of the company, effective immediately.
NIO		Hot Stocks 06:28 EDT Nio delivers 20,176 vehicles in August, 128,100 vehicles year-to-date - Nio announced its August 2024 delivery results. The company delivered 20,176 vehicles in August 2024. The deliveries consisted of 11,923 premium smart electric SUVs, and 8,253 premium smart electric sedans. Cumulative deliveries of Nio vehicles reached 577,694 as of August 31, 2024. The company delivered 128,100 vehicles year-to-date in 2024, increasing by 35.8% year-over-year.
XPEV		Hot Stocks 06:26 EDT XPeng delivers 14,036 Smart EVs in August, up 3% year-over-year - XPeng announced its vehicle delivery results for August 2024. The company delivered 14,036 Smart EVs in August, representing increases of 3% year-over-year and 26% over the prior month. In the first eight months of 2024, XPeng delivered 77,209 Smart EVs, a 17% increase from the same period last year.
ZK		Hot Stocks 06:24 EDT Zeekr delivers 18,015 vehicles in August, up 46% year-over-year - Zeekr announced its delivery results for August 2024. The company delivered 18,015 vehicles in August 2024, marking a 46% year-over-year increase. Year-to-date, Zeekr has delivered 121,540 vehicles in 2024, representing 81% growth compared to the same period last year. By the end of August 2024, ZEEKR's cumulative deliveries had reached 318,173. On August 30, Zeekr officially launched its mid-to-large SUV, the ZEEKR 7X, revealing additional interior design details. The ZEEKR 7X boasts an exceptionally spacious and comfortable cabin, offering best-in-class front-row headroom and second-row legroom among midsize SUVs. Deliveries for the Chinese market are scheduled to commence by the end of September, with global deliveries expected to follow within the next year.
CYTK		Hot Stocks 06:23 EDT Cytokinetics presents new safety, long-term use data of aficamten - Cytokinetics announced that new data related to the safety and long-term use of aficamten were presented in a Late Breaking Clinical Trial presentation and oral presentation at the European Society of Cardiology Congress 2024 in London, U.K. The presentations included an integrated safety analysis from three clinical studies of aficamten and an analysis of the withdrawal of standard of care medications in patients treated with aficamten in FOREST-HCM, the open label extension clinical study of aficamten in patients with hypertrophic cardiomyopathy. Patients with obstructive HCM who received at least one dose of aficamten or placebo were included in this analysis. A total of 283 patients received at least one dose of aficamten and 153 patients received at least one dose of placebo. Overall, treatment with aficamten was well-tolerated with an adverse event profile similar to placebo. Across all three clinical studies, 11 patients experienced incidents of left ventricular ejection fraction less than50%, but none were associated with clinical heart failure, and all were successfully managed by dose down-titration. Additionally, of the 1,588 total echocardiograms performed on patients treated with aficamten during the maintenance phases of each clinical study, only 0.7% of echocardiograms that were performed impacted the clinical management of patients and led to a reduction in dose. There were no dose interruptions and no treatment discontinuations in these three clinical studies of aficamten due to decreased LVEF. Additionally, among patients treated with aficamten and compared to placebo, there was a low incidence of new onset atrial fibrillation and myocardial infarction. The rate of syncope events was also similar between groups. This integrated safety analysis reinforces the safety profile of aficamten as relates to the potential management of HCM in a real-world setting. Of the 145 patients with obstructive HCM who completed at least 24 weeks of treatment with aficamten at the time of this analysis, 136 were receiving SoC medications including beta blockers, calcium channel blockers and disopyramide. Withdrawal of SoC medications was attempted at the discretion of the investigator in 64 patients, while a comparator group of 72 patients did not undergo SoC withdrawal. Successful withdrawal was defined as at least a 50% dose-reduction in one medication relative to baseline. Among patients who attempted withdrawal of SoC medications, 59 were successful, including 38 patients who discontinued at least one SoC medication and 27 patients who achieved and maintained monotherapy with aficamten. Following successful withdrawal of SoC medications, 23 patients underwent dose up-titration with aficamten. Among those who attempted withdrawal of SoC medications, there were no statistically significant differences in the treatment effect of aficamten post-withdrawal compared to pre-withdrawal on resting left ventricular outflow tract gradient, Valsalva LVOT-G, change in LVEF, New York Heart Association Functional Class, Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, high-sensitivity cardiac troponin I and NT-proBNP. There were no differences in the efficacy of aficamten between the group of patients who attempted SoC withdrawal and the control group of patients who did not attempt SoC withdrawal. Further, no differences in safety profile emerged, with similar rates of adverse events, instances of LVEF less than50% and new onset atrial fibrillation between groups. These data suggest that aficamten may be tolerated and effective as monotherapy in patients with obstructive HCM and warrants further evaluation.
CYTK		Hot Stocks 06:20 EDT Cytokinetics presents additional data from SEQUOIA-HCM - Cytokinetics announced that additional data from SEQUOIA-HCM, the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy, related to cardiac remodeling and improvements in patient symptoms, cardiac structure, function and biomarkers, were presented in three Late Breaking Clinical Trial presentations and one oral presentation at the European Society of Cardiology Congress 2024 in London, U.K. The primary endpoint in the CMR sub-study was the change from baseline to Week 24 in left ventricular mass index from baseline. Treatment with aficamten significantly improved LVMI and resulted in favorable cardiac remodeling as demonstrated by reductions in left ventricular maximal wall thickness, left atrial volume index, and extracellular volume mass index, while replacement fibrosis remained stable. These observed structural changes are suggestive of ongoing favorable remodeling and occurred in conjunction with improvements in clinical endpoints including resting and Valsalva left ventricular outflow tract gradient, NT-proBNP and NYHA Functional Class. A CMR sub-study is also being conducted in FOREST-HCM, the ongoing open-label extension clinical trial of aficamten, to evaluate cardiac remodeling associated with long-term treatment with aficamten, as well as in ACACIA-HCM, the pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive HCM. As previously reported, treatment with aficamten significantly improved gradients by approximately 60%, improving placebo-corrected resting LVOT-G -40 mmHg and Valsalva LVOT-G -50 mmHg, with no significant adverse changes in left ventricular systolic function, as measured by left ventricular ejection fraction. Aficamten also improved measures of left ventricular structure and function including maximal wall thickness, septal wall thickness, inferolateral wall thickness, left ventricular mass index, and left ventricular end systolic volume index, with no change in left ventricular end diastolic volume index. Aficamten also improved LAVI as well as left ventricular relaxation and filling as indicated by an increase in lateral e' velocity and decrease in lateral E/e', findings consistent with an improvement in diastolic function. The improvements in these echocardiographic measures were each associated with improvements in pVO2, Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and NT-proBNP, demonstrating that the effects of aficamten on cardiac function and structure were associated with improvements in exercise capacity, symptoms and quality of life. Very large improvements in KCCQ-OSS were achieved by 30% of patients treated with aficamten compared to 12% of patients treated with placebo. Similarly, aficamten significantly improved SAQ-SS scores by 7.8 points, with 31% of patients treated with aficamten experiencing a very large improvement compared to 14% of patients on placebo. No significant heterogeneity was observed in improvements in KCCQ-OSS and SAQ-SS according to patient baseline characteristics, including the severity of disease or level of symptom burden. Even in patients with minimal angina at baseline, SAQ-SS scores improved after 24 weeks of treatment with aficamten. These results indicate that treatment with aficamten significantly improves patient health status including symptoms, function and quality of life. Higher baseline concentrations of NT-proBNP and hs-cTnI were associated with worse baseline echocardiographic measures of disease severity including resting and Valsalva LVOT-G, LVEF and left ventricular wall thickness. Treatment with aficamten for 24 weeks resulted in an 80% reduction in NT-proBNP and a 43% reduction in hs-cTnI. Both measurements returned to baseline after washout. Baseline measurements of NT-proBNP and hs-cTnI were not correlated with change in pVO2 such that treatment with aficamten significantly improved pVO2 irrespective of baseline biomarkers. Baseline NT-proBNP and hs-cTnI also did not predict future instances of LVEF less than50%. However, at 24 weeks, improvements in NT-proBNP and hs-cTnI were strongly associated with improvements in LVOT-G, pVO2 and KCCQ. Improvements in NT-proBNP were shown to closely mirror improvements in pVO2, which was not directly related to the reduction in LVOT-G, indicating that NT-proBNP may serve as an independent surrogate for change in pVO2. Additionally, changes in NT-proBNP as early as Week 2 were strongly associated with changes in Valsalva LVOT-G, KCCQ-CSS, LAVI and lateral E/e' at Week 24, indicating that early improvements in NT-proBNP may be a signal of future treatment effect. These results indicate that NT-proBNP may be a potentially useful tool to monitor functional and symptomatic improvements in response to treatment with aficamten.
BMY		Hot Stocks 06:15 EDT Bristol announces new long-term follow-up data from Phase 3 Study of CAMZYOS - Bristol Myers announced new long-term follow-up results from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension study evaluating CAMZYOS in adult patients with New York Heart Association class II-III symptomatic obstructive hypertrophic cardiomyopathy. The long-term follow-up efficacy and safety data, presented today at the European Society of Cardiology Congress in London, reinforce the established efficacy and safety profile of CAMZYOS, a first-in-class cardiac myosin inhibitor. With inclusion in both the ESC and AHA/ACC clinical guidelines as a recommended option for when symptoms persist after first-line therapy, CAMZYOS is a standard of care for symptomatic oHCM. Patients experienced consistent and sustained improvements in echocardiographic measures and biomarkers after up to 3.5 years of continuous treatment, including resting left ventricular outflow tract gradient, Valsalva LVOT gradient, left atrial volume index and N-terminal pro B-type natriuretic peptide levels. They also experienced an improvement in symptoms and functional capacity as measured by NYHA class and patient-reported outcomes, including most patients achieving NYHA class I. The safety profile of CAMZYOS for up to 3.5 years remained consistent with the established safety profile, with no new safety signals identified. Key findings from the EXPLORER-LTE data analysis showed sustained improvements from baseline to Weeks 156 and 180 in echocardiographic measures and biomarkers. In echocardiographic markers, patients experienced a reduction of 55.3 mmHg in Valsalva LVOT gradient at both Week 156 and 180 and a reduction of 40.2 mmHg and 40.3 mmHg in mean resting LVOT gradient at Week 156 and 180, respectively. Improvements from baseline to Weeks 144 and 180 were sustained in mean left atrial volume index, with patients experiencing a reduction of 3.5 mL/m2 and 5.5 mL/m2, respectively. The mean left ventricular ejection fraction decreased by 11% from baseline to Week 180, and the mean (63.9%) remained within normal range. Evaluation of biomarker data showed that median NT-proBNP levels decreased by 504 ng/L at Week 156 and 562 ng/L by Week 180. At Week 180, most patients were NYHA class I. Overall, 108 patients achieved a complete response - defined as achieving NYHA class I and a Valsalva LVOT gradient of less than or equal to30 mmHg during the study and retained a complete response until the data cutoff. Patient-reported outcomes as measured by the HCM Symptom Questionnaire found improvement in shortness of breath score from baseline with treatment during the first 12 weeks and was sustained through Weeks 156 and 180.
LI TSLA		Hot Stocks 06:12 EDT Li Auto delivers 48,122 vehicles in August, up 37.8% year-over-year - Li Auto announced that it delivered 48,122 vehicles in August 2024, an increase of 37.8% year-over-year. This brought the company's total deliveries in 2024 to 288,103. As of August 31, 2024, its cumulative deliveries reached 921,467 vehicles. "Li L6 has gained widespread popularity among young users, with deliveries exceeding 20,000 for the third consecutive month, further expanding our market share. Notably, our share of the RMB200,000 and higher NEV market grew to 18% in July, outpacing Tesla to become the sales champion among NEV brands in China. We maintained our strong momentum, retaining the top spot in sales among China's emerging new energy auto brands in August. During the third quarter, we have been enhancing the product strength across all our models through continued OTA updates, further boosting user satisfaction and driving our NPS to a new high for the year to date. Additionally, our full-stack proprietary autonomous driving architecture, which integrates an end-to-end (E2E) model and a vision-language model (VLM), showcased its strong capabilities and potential for further evolution during user testing. The penetration rate of city NOA mileage among test users has exceeded 50%," commented Xiang Li, chairman and chief executive officer of Li Auto. "As we enhance autonomous driving system, we are also maximizing the effectiveness of our active safety features. We rolled out the industry's first fully automatic emergency steering function, providing users dual protections in extreme scenarios through AEB and AES. We would like to express our gratitude to over 900,000 families for choosing Li Auto. Their recognition serves as a long-term driving force behind our commitment to investing in research and development. We will remain steadfast in our focus on user value to create greater happiness for families in this era of AI innovation."