Stockwinners Market Radar for June 25, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

APO...

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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. A group of investors led by Apollo Global Management (APO) is making a more than $1B debt investment in Wolfspeed (WOLF), a publicly traded semiconductor maker with a $6B market capitalization, The Information's Maria Heeter reports, citing a person familiar with the matter. The deal could be announced in the coming days and would be one of the largest direct lending deals of the year that doesn't involve a takeover, the author notes. 2. Law-enforcement officials and retailers are investigating a recent wave of bomb threats across the U.S. targeting grocery operators and other stores, The Wall Street Journal's Jaewon Kang reports. Kroger (KR), Walmart (WMT), Amazon's (AMZN) Whole Foods Market and other companies have received bomb threats at stores in various areas from New Mexico to Wisconsin in recent months, according to authorities. Some callers demanded gift cards, bitcoin or money, and threatened to detonate bombs if payments weren't made. 3. Tesla's (TSLA) shares have soared this year, but they're also exceptionally volatile, Al Root writes in this week's edition of Barron's. The publication recommended buying the stock on January 6, and while it is "not giving up on shares," it says this is "as good a time as any to sell a little bit of Tesla," using volatility to one's advantage. 4. Sony's (SONY) "Spider-Man: Across the Spider-Verse" won the weekend at the North American box office, with $19.3M in its fourth outing as the film crossed the $300M mark domestically. "Spider-Man: Across the Spider Verse" sports an impressive $560.3M globally. 5. Boston Beer (SAM), United Rentals (URI), Deere (DE), Eaton (ETN), Schneider Electric (SBGSY), Quanta Services (PWR), Johnson Controls International (JCI), Noble (NE), Transocean (RIG), Valaris (VAL), Seadrill (SDRL), and Diamond Offshore Drilling (DO) saw positive mentions in this week's edition of Barron's.
TAK

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16:25 EDT Takeda presents interim results from pivotal Phase 3 trial for TAK-755 - Takeda presented favorable interim results from a global pivotal Phase 3 randomized, controlled, open-label, crossover trial evaluating the safety and efficacy of TAK-755 replacement therapy for the prophylactic treatment of congenital thrombotic thrombocytopenic purpura, or cTTP, and pharmacokinetics characteristics of TAK-755, as well as long-term data on TAK-755 prophylaxis from a Phase 3b continuation study. In the pivotal trial, no patient had an acute TTP event while receiving TAK-755 prophylactic treatment. TAK-755 also reduced the incidence of thrombocytopenia by 60%, as compared to plasma-based therapy. Thrombocytopenia, an important marker of disease activity, was the most frequently observed TTP manifestation. In addition, the results show that TAK-755 demonstrated a favorable safety and tolerability profile, with a potential safety advantage over plasma-based therapies. In the pivotal trial, treatment-emergent adverse events were reported in 10.3% of patients ages 12-68 receiving TAK-755 compared to 50% of patients receiving plasma-based therapy. PK characteristics of ADAMTS13 after a single infusion were evaluated and compared to plasma-based therapy in 36 cTTP patients aged 12 and older. Patients receiving TAK-755 achieved a five-fold increase in their ADAMTS13 activity levels compared to those receiving plasma-based therapy and lower variability. Takeda also presented an interim analysis of the Phase 3b continuation study, evaluating the safety and efficacy of long-term TAK-755 prophylaxis in 29 patients with cTTP. Results demonstrated a consistently favorable safety profile with TAK-755 prophylaxis and no development of neutralizing antibodies. Zero acute TTP events occurred during TAK-755 prophylaxis, and the incidence rates of subacute TTP events and TTP manifestations were comparable to those with TAK-755 prophylaxis in the pivotal study.
MLTX

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09:36 EDT MoonLake announces Phase 2 results for Nanobody sonelokimab in HS - MoonLake Immunotherapeutics announced top-line results from its global Phase 2 MIRA trial evaluating the efficacy and safety of the Nanobody sonelokimab in patients with moderate-to-severe hidradenitis suppurativa, or HS. The MIRA trial, which recruited 234 patients, is the first randomized, double-blind, placebo-controlled trial to use Hidradenitis Suppurativa Clinical Response 75 as its primary endpoint, a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, therefore representing a landmark milestone in HS clinical development. The trial met its primary endpoint with a significantly greater proportion of patients treated with both sonelokimab 120mg and 240mg achieving HiSCR75 compared to those on placebo at week 12. The primary analysis was based on the most stringent type of analysis for such trials, intent-to-treat non-responder imputation. Both doses performed similarly, with the 120mg dose providing the highest delta on HiSCR75 and HiSCR50. The 120mg dose achieved a 29 ppt delta to placebo on HiSCR75 and a 38ppt delta to placebo on HiSCR50. The results suggest that, as early as week 12, the Nanobody sonelokimab, relative to placebo, reaches the highest clinical activity among all other therapies tested in similarly stringent pivotal-like trials. In addition, other clinically relevant secondary endpoints, such as HiSCR90, improvements in International Hidradenitis Suppurativa Severity Score System 4, abscess/nodule and draining tunnel counts as well as patient reported pain and quality of life outcomes also reached statistical significance at week 12. The high performance of the Nanobody at 120mg, the dose found to be optimal in psoriasis, demonstrates the advantage of using a smaller biologic with albumin-binding capacity to inhibit IL-17A and IL-17F for the treatment of inflammatory diseases. The safety profile of sonelokimab was consistent with previously reported studies with no new safety signals observed. Overall, sonelokimab continues to show a favorable safety profile, in line with the known profile of IL-17 inhibitors.
RLYB

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07:03 EDT Rallybio announces proof-of-concept results, development updates for RLYB212 - Rallybio reported data from the Phase 1b proof-of-concept study of RLYB212, a novel monoclonal anti-HPA-1a antibody in development for the prevention of fetal and neonatal alloimmune thrombocytopenia. The data showed that subcutaneous RLYB212 administration produced a dose-dependent, rapid and complete elimination of transfused HPA-1a positive platelets in HPA-1a negative subjects, with both doses meeting the prespecified proof-of-concept criteria of greater than or equal to 90% reduction in mean platelet elimination half-life. Mean platelet elimination half-life was 5.8 hours and 1.5 hours for RLYB212 compared to 71.7 hours for placebo. Consistent with previously reported data, RLYB212 was observed to be well-tolerated with no reports of serious or severe adverse events. Rallybio remains on track to complete the following RLYB212 milestones in the fourth quarter of 2023: Comprehensive toxicology program, including maternal-fetal toxicology; Multiple dose cohort of Phase 1 safety and PK study; Phase 2 Dose Confirmation Study. The Company plans to initiate a Phase 2 dose confirmation study in the second half of 2024, designed to confirm the RLYB212 dose regimen in pregnant women at higher risk of FNAIT prior to initiation of a larger Phase 3 registrational study. This study will employ a sentinel, sequenced cohort design to allow for any required adjustments to the dose regimen, prior to advancing the confirmed dose regimen into the registrational study.
ESPR

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07:00 EDT Esperion presents results from CLEAR Outcomes primary prevention analysis - Esperion announced the results from the pre-specified, primary prevention CLEAR Outcomes subgroup analysis at the 83rd American Diabetes Association Scientific Sessions. Results from this primary prevention analysis show a significant reduction in cardiovascular risk, including a 36% risk reduction of MACE-3, and a 30% risk reduction of MACE-4 in the primary prevention population. The data were simultaneously published in the renowned peer-reviewed Journal of the American Medical Association.
LLY

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06:58 EDT Eli Lilly's SURMOUNT-2 results show tirzepatide led to superior weight reduction - Detailed results from SURMOUNT-2, a phase 3 clinical trial evaluating the efficacy and safety of Eli Lilly's tirzepatide for chronic weight management in participants with obesity or overweighti and type 2 diabetes, showed that tirzepatide led to superior weight reduction versus placebo for both doses. The data were presented during a symposium at the American Diabetes Association's 83rd Scientific Sessions and were simultaneously published in The Lancet. Tirzepatide met both co-primary endpoints and all key secondary endpoints compared to placebo for both estimands, with those taking tirzepatide achieving a mean weight reduction of 13.4% on 10 mg and 15.7% on 15 mg compared to 3.3% on placebo for the efficacy estimand, which evaluates the treatment effect if all participants adhered to treatment. For the efficacy estimand, 81.6% and 86.4% of people taking tirzepatide achieved at least 5% body weight reduction, compared to 30.5% of those taking placebo. Both doses of tirzepatide achieved all key secondary endpoints at 72 weeks of treatment for the efficacy estimand. Additionally, tirzepatide met the co-primary and all key secondary endpoints for the treatment-regimen estimand, which represents the average results of all study participants regardless of treatment adherence. The overall safety profile of tirzepatide was consistent with previously reported SURMOUNT and SURPASS trials and similar to incretin-based therapies approved for the treatment of obesity and overweight. The most commonly reported adverse events were gastrointestinal-related and were generally mild to moderate in severity, and usually occurred during the dose-escalation period. Regulatory action for the U.S. submission for tirzepatide in adults with obesity, or overweight with weight-related comorbidities is expected by the end of 2023.
ARWR TAK

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06:55 EDT Arrowhead presents updated data from Phase 2 SEQUOIA study - Arrowhead Pharmaceuticals (ARWR) presented updated results from the Phase 2 SEQUOIA clinical study of investigational fazirsiran for the treatment of liver disease associated with alpha-1 antitrypsin deficiency. The SEQUOIA Phase 2 data are consistent with the promising results from an open-label Phase 2 trial of fazirsiran that were published in The New England Journal of Medicine. Takeda (TAK) and Arrowhead are further investigating fazirsiran in the ongoing pivotal Phase 3 REDWOOD clinical study which is actively recruiting a total of 160 patients. The updated Phase 2 clinical data were presented at the European Association for the Study of the Liver Congress 2023 in an oral presentation titled. Fazirsiran reduced serum Z-AAT concentration in a dose-dependent manner. At week 48, patients receiving 25, 100, or 200 mg fazirsiran achieved serum Z-AAT reductions of 74%, 89%, and 94%, respectively, versus an increase of 9% observed in patients receiving placebo. Fazirsiran significantly reduced liver Z-AAT. Patients receiving 200 mg fazirsiran achieved a least-squares mean percentage difference versus placebo at post-dose biopsy of -141%. Fazirsiran consistently reduced hepatic globule burden. 100% of patients in the pooled fazirsiran treatment group achieved at least a 1-point improvement in PASD-positive globule burden. Fazirsiran treatment reduced histological signs of hepatic inflammation. 42% of patients in the pooled fazirsiran treatment group achieved at least a 1-point improvement in portal inflammation versus 0% in the placebo group. 67% of patients in the pooled fazirsiran treatment group achieved at least a 1-point improvement in interface hepatitis versus 0% in the placebo group. 50% of the pooled fazirsiran treated patients showed at least a 1-point improvement in METAVIR liver fibrosis versus 38% in the placebo group. Fazirsiran has been well tolerated to date. Pulmonary function test results for both fazirsiran and placebo were stable over time with no apparent dose-dependent effects.
VIR

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06:47 EDT Vir Biotechnology presents new data evaluating potential for VIR-2218, VIR-3434 - Vir Biotechnology announced new data from its hepatitis B and D virus portfolio that were presented at the EASL, or European Association for the Study of the Liver, Congress. Data presented in a late-breaker oral presentation from a Phase 2 clinical trial demonstrated that when VIR-2218, an investigational small interfering ribonucleic acid, was given for 24 or 48 weeks on top of a course of up to 48 weeks of pegylated interferon alpha, 16% achieved sustained HBsAg loss 24 weeks following the end of treatment. In a poster presentation, new pharmacokinetics data support the safety, tolerability and antiviral activity of a 300 mg dose of VIR-3434, an investigational monoclonal antibody, which is being evaluated for the treatment of chronic HBV and HDV infection across multiple ongoing clinical trials. In addition, preclinical data presented in a separate poster showed evidence of antiviral efficacy of VIR-2218 and VIR-3434 against HDV infection by demonstrating reduced levels of HBsAg, HDV and HBV viremia in vivo with the parental molecule of VIR-3434 as well as reduced HBV antigens and secreted infectious HDV virions in vitro with both single and combination therapies of VIR-2218 and VIR-3434. These data further support the clinical development of these investigational medicines for the treatment of HDV.
ETNB

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06:45 EDT 89bio publishes results from Phase 2 ENTRIGUE trial of pegozafermin in SHTG - 89bio announced that the previously reported positive data from the Phase 2 ENTRIGUE trial of pegozafermin in patients with severe hypertriglyceridemia were published online in Nature Medicine. As previously announced, ENTRIGUE met its primary endpoint of demonstrating statistically significant reductions in median triglycerides from baseline in pegozafermin-treated patients across all dose groups compared to placebo after eight weeks of treatment. Significant reductions in TGs were observed consistently across all prespecified patient subgroups, including those on lipid-modifying background therapies. Additionally, the ENTRIGUE trial met multiple secondary endpoints, showing that treatment with pegozafermin led to improvements in atherogenic lipoproteins, metabolic measures, liver fat, and markers of liver inflammation. Data from the ENTRIGUE trial show pegozafermin significantly reduced TGs after only eight weeks of treatment across all dose groups, with placebo-corrected changes from baseline ranging from -29% to -53%. In pooled data across all doses, pegozafermin lowered TG levels to less than 500 mg/dL in 80% of patients compared to 29% of patients on placebo. The trial also demonstrated that pegozafermin had positive effects on atherogenic lipids, including improvements in levels of non-HDL-C and apolipoprotein B, across the majority of patients. Importantly, reductions in both triglycerides and atherogenic lipoproteins occurred regardless of whether patients were on lipid-modifying background therapy. Additionally, robust reductions in liver fat were observed across all dose groups, as evaluated with magnetic resonance imaging - proton density fat factor, including 88% of patients who achieved a greater than or equal to30% reduction in liver fat from baseline and 24% who achieved normalized levels of liver fat after 8 weeks of treatment. Pegozafermin was well tolerated with a favorable safety profile across doses.
ETNB

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06:41 EDT 89bio presents data from ENLIVEN Phase 2b trial of pegozafermin in NASH - 89bio announced that data from the Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis were published online in the New England Journal of Medicine. The data were simultaneously presented in a late-breaking oral session at the European Association for the Study of the Liver Congress 2023 in Vienna, Austria and were also selected for inclusion in the Best of EASL Congress summary. The randomized, double-blind, placebo-controlled 24-week Phase 2b ENLIVEN trial evaluated 219 adult patients of whom 192 had biopsy-confirmed fibrosis stages F2-F3 NASH and NAS greater than or equal to 4 for 24 weeks. In this trial, treatment with 44mg every-two-week and 30mg dosing groups resulted in statistically significant changes on both primary histology endpoints demonstrating at least one-stage fibrosis improvement without worsening of NASH at 3.5 times the placebo rate and NASH resolution without worsening of fibrosis, between 12 to 14 times the placebo rate. Treatment with pegozafermin also led to clinically meaningful changes compared to baseline in liver fat and other key non-invasive tests of liver inflammation and fibrosis. Improvements were observed in HbA1c, adiponectin and across lipid markers that are important factors for an effective treatment for NASH. In addition, reductions in liver and spleen volume were observed. The trial included 14 biopsy confirmed NASH patients with compensated cirrhosis who were not part of the primary analysis, but continued in the study, 12 of which underwent a follow-up biopsy at Week 24. Five out of eleven of these patients treated with pegozafermin had fibrosis improvement greater than or equal to1 stage without worsening of NASH.
BMEA

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06:38 EDT Biomea Fusion presents data from initial cohorts of Phase II study of BMF-219 - Biomea Fusion announced the presentation of new clinical data from the first two cohorts of patients with T2D enrolled in the Phase II portion of its ongoing Phase I/II clinical study, COVALENT-111, of BMF-219, the company's investigational oral covalent menin inhibitor. 40 patients were enrolled in the first three Multiple Ascending Dose cohorts of COVALENT-111, with the first cohor comprising 16 healthy volunteers; 12 HVs received 100 mg of BMF-219 once daily and 4 HVs received placebo QD for two weeks and thereafter followed off treatment for an additional six weeks. In Cohorts 2 and 3, T2D patients were treated for four weeks with or without food, respectively, and then followed for 22 weeks after treatment. In these two treatment cohorts, enrolled patients had T2D diagnosed for less than 15 years, were between the ages of 18 to 65, had been treated with lifestyle management with or without up to three standard-of-care anti-diabetic medications, excluding sulfonylureas and insulin, with a stable dosing regimen for at least two months prior to screening, had a BMI greater than or equal to 25 and less than or equal to 40 kg/m2, and had poorly controlled diabetes. At baseline, diabetic patients in Cohorts 2 and 3, had a mean HbA1c of 8.0% and 8.1%, respectively. As reported in March 2023, during the 4-week dosing period BMF-219 was generally well tolerated; all patients completed the treatment, and all patients continue to be in follow-up to assess the durability of the treatment effect. There were no dose reductions, dose discontinuations, or severe or serious adverse events. No patients showed symptomatic hypoglycemia, significant changes in hemoglobin levels, or other TEAEs. During the off-treatment period, no severe or serious TEAEs were noted. Dosing of patients in the 200 mg without food cohort was recently completed and is now in the follow-up period. The 200 mg with food cohort led to an increase in mild to moderate nausea compared to 200 mg without food. This cohort will be transitioned to 100 mg BID dosing. No other clinical symptoms or clinical concerns were observed in this dose level. In the HV Cohort 1, 2 of 12 patients treated with BMF-219 and 1 of 4 patients treated with placebo showed mild TEAEs. No other TEAEs were observed.
LLY

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06:34 EDT Eli Lilly announces new Phase 2 data for orforglipron - Eli Lilly announced new Phase 2 data for orforglipron, its first nonpeptide oral glucagon-like peptide-1 receptor agonist being studied for chronic weight management in participants with obesity or overweighti. The results were shared during an oral presentation at the American Diabetes Association's 83rd Scientific Sessions and were simultaneously published in the New England Journal of Medicine. Orforglipron met both primary and secondary endpoints for the efficacy estimandii and demonstrated clinically significant weight reductions in adults with obesity or overweight, with at least one weight-related comorbidity. At the 26-week primary endpoint, orforglipron showed statistically significant dose-dependent body weight reductions for all doses ranging from 8.6% to 12.6% compared to 2.0% for placebo. For those taking orforglipron, body weight continued to decrease at 36 weeks where all doses achieved body weight reductions ranging from 9.4% to 14.7% compared to 2.3% for placebo. The mean baseline body weight of participants was 240 lb. The safety profile of orforglipron was similar to other incretin-based therapies. Gastrointestinal side effects were the most commonly reported adverse events, were generally mild-to-moderate in severity, and usually occurred during the dose escalation period. Lilly has initiated Phase 3 development programs to further study the efficacy and safety of orforglipron for the treatment of obesity and overweight and type 2 diabetes.
MDT

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06:31 EDT Medtronic presents new data on MiniMed 780G system - Medtronic presented a collection of new clinical and real-world data on the MiniMed 780G system. These latest data sets, which evaluated the system across a wide range of users, including historically challenging younger patients, those not meeting glycemic goals, and individuals using a simplified meal announcement leveraging fixed carbohydrate amounts instead of exact carb calculations, found that the proprietary Meal Detection technology supported Time in Range outcomes that exceed consensus guidelines of 70 percent. Additionally, the system is helping reduce the percent of time spent in hyperglycemia in children and adults. These latest results were presented this weekend at the 83rd American Diabetes Association Scientific Sessions in San Diego, CA. The first study randomly assigned adolescents using the MiniMed 780G system into two groups, with some entering a fixed pre-set number of carbs and some calculating a precise number of carbs for their meals. These individuals had lived with diabetes for at least one year and used multiple daily injections or pump therapy prior to the study. Results from the study showed those using the simplified carb entry maintained international targets for glycemic control, including an A1c of 6.9% and Time in Range of 72.7% over 6 months without system modification. Additionally, the simplified entry group lowered their time above 250 mg/dL from 28.3% to 5.3% at six months. After 3 months, 88% chose to continue with the simplified meal management approach, which suggests user satisfaction with this less burdensome approach. These results suggest that reduced accuracy in carb counting can be overcome by the increased automated insulin delivery provided by the MiniMed 780G system, and that even those that cannot or do not input their carbs precisely can reach glycemic goals and reduce hyperglycemia. An analysis of real-world evidence of children less than or equal to 15 years in Europe and Latin America using the MiniMed 780G system with recommended settings of 100 mg/dL and 2-hour active insulin time demonstrated a Time in Range of 78%. A separate analysis of real-world evidence of children less than or equal to 15 years in Europe demonstrated improved glycemic performance in SmartGuard technology regardless of baseline glycemic control. The group with the lowest Time in Range prior to SmartGuard technology, had the largest increase of 23.3% in Time in Range, while patients with the best metabolic control in SmartGuard technology achieved 80.6% Time in Range. Additionally, this increase in Time in Range was seen with less effort as evidenced by fewer user-initiated boluses, indicating decreased patient burden. For the first time, real-world data on the Medtronic Extended Infusion Set was presented and the analysis showed an average infusion set wear time of 6.74 days. Almost half of the individuals evaluated wore the set for 7 days. This real-world data mirrors the results from the U.S. pivotal trial and is delivering a reduced user burden through less frequent infusion set changes.
LXRX

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06:20 EDT Lexicon announces planned advancement of LX9211 into late-stage development - Lexicon Pharmaceuticals announced plans to advance its investigational drug LX9211 into late-stage development in a clinical program directed towards an application for regulatory approval in diabetic peripheral neuropathic pain, or DPNP. The first late-stage study will be a Phase 2b dose optimization study, with start-up scheduled in the third quarter of 2023 and the initiation of dosing expected in the fourth quarter. The Phase 2b study includes an extension to run in parallel with planned next-stage Phase 3 studies.