Stockwinners Market Radar for October 27, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:01 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. TSMC (TSM) suspended shipments to China-based chip designer Sophgo after a chip it made was found on a Huawei AI processor, Reuters' Karen Freifeld and Fanny Potkin report, citing two people familiar with the matter. Sophgo had ordered chips from TSMC that matched the one found on Huawei's Ascend 910B, the people said. Huawei is restricted from buying the technology to protect U.S. national security. 2. McDonald's (MCD) on Sunday ruled out beef patties as a source of the E. coli outbreak linked to Quarter Pounder hamburgers, which has killed at least one person and sickened nearly 75 others, Reuters reports. "We remain very confident that any contaminated product related to this outbreak has been removed from our supply chain and is out of all McDonald's restaurants," the fast-food chain's Chief Supply Chain Officer Cesar Pina said in a statement. 3. Schneider Electric (SBGSY) might not be a household name in the U.S., but there's a good chance an investor has one of its "Square D" breaker boxes in their basement. Its business is much more than fuses and electrical outlets, though. Its 168,000-strong global workforce makes hardware and software enabling the electrification of just about everything, Al Root writes in this week's edition of Barron's. Sales in 2024 are expected to come in at about $41 billion, up about 5% from the previous year, driven, in part, by insatiable electricity demand from power-hungry AI data centers. If all goes well, the stock can gain 25% in the coming year, the author writes. 4. Sony's (SONY) "Venon: The Last Dance" won this weekend at the North American box office with a $51M debut, which was slightly behind expectations. Overseas, the final title in Sony's franchise earned and estimated $124M for a global cume of $175M. 5. General Motors (GM), Marathon Petroleum (MPC), Wells Fargo (WFC), AIG (AIG), State Street (ST), Jabil (JBL), Expedia (EXPE), MGM Resorts (MGM), Archer Daniels-Midland (ADM), Altria Group (MO), Dupont (DD), and Comcast (CMCSA) saw positive mentions in this week's edition of Barron's.

16:17 EDT Novartis presents 12-month data from the Phase III APPEAR-C3G study - Novartis presented 12-month data from the Phase III APPEAR-C3G study at American Society of Nephrology Kidney Week 2024 showing that patients with C3 glomerulopathy treated with oral Fabhalta in addition to supportive care experienced clinically meaningful, sustained results at one year. These data confirm treatment with Fabhalta resulted in clinically meaningful proteinuria reduction, which was seen as early as 14 days, and sustained at 12 months. Similarly, in an open-label period of the study, proteinuria reduction was seen in participants who were switched to Fabhalta. In addition, improvement in estimated glomerular filtration rate slope was observed upon Fabhalta initiation compared to patients' historic rapid decline based on results from a prespecified exploratory analysis. Fabhalta showed a favorable safety profile, with no new safety signals. APPEAR-C3G evaluated the efficacy and safety of twice-daily oral Fabhalta in adult patients with C3G. The study was comprised of a 6-month randomized, double-blind treatment period with Fabhalta compared to placebo, followed by an additional 6-month open-label treatment period where all participants received Fabhalta.1 Results previously presented at the 2024 European Renal Association Congress demonstrated a statistically significant and clinically meaningful 35.1% proteinuria reduction vs. placebo on top of supportive care at 6 months. Approximately 50% of C3G patients progress to kidney failure within 10 years of diagnosis, at which point they require lifelong dialysis and/or kidney transplantation.

08:37 EDT Apellis, Sobi announced results from Phase 3 VALIANT study - Apellis Pharmaceuticals and Sobi announced that results from the Phase 3 VALIANT study were presented as an oral presentation during the High-Impact Clinical Trials session at the American Society of Nephrology Kidney Week. The results highlighted the strength of systemic pegcetacoplan treatment in patients with C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis, which are rare, debilitating kidney diseases. Statistically significant 68% proteinuria reduction across a broad study population, with reduction observed as early as Week 4 Pegcetacoplan-treated patients showed a statistically significant and clinically meaningful 68.1% proteinuria reduction compared to placebo, both in addition to standard of care therapy, at Week 26. The proteinuria reduction was observed as early as Week 4 and continued through the six-month treatment period. Proteinuria reduction was consistent across broad patient subgroups including adolescent and adult patients, C3G and IC-MPGN patients, and patients with native and post-transplant kidneys. Patients treated with pegcetacoplan achieved stabilization of estimated glomerular filtration rate, a key measure of kidney function, with a difference of +6.3mL/min/1.73m2 over six months compared to placebo. Additionally, a substantial proportion of patients treated with pegcetacoplan demonstrated a reduction in C3c staining intensity. Excessive C3c deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. 74.3% of patients in the pegcetacoplan group and 11.8% on placebo achieved a reduction in C3c staining intensity by two or more orders of magnitude from baseline, resulting in 27-fold higher odds of achieving this reduction with pegcetacoplan. 71.4% of pegcetacoplan-treated patients achieved zero C3c staining intensity, demonstrating complete clearance of C3c deposits. In addition to the positive results on proteinuria, eGFR, and C3c staining, pegcetacoplan demonstrated statistical significance on the key secondary endpoints of composite renal endpoint, which combines proteinuria reduction and eGFR stabilization, and proteinuria reduction of at least 50% compared to baseline, as well as a numerical improvement in the C3G histologic index activity score. During the randomized, controlled 26-week treatment period, pegcetacoplan demonstrated favorable safety and tolerability, as well as a high compliance rate, consistent with its established profile. Rates of treatment-emergent adverse events, serious AEs, severe AEs, and AEs leading to study discontinuation were similar between the pegcetacoplan and placebo groups. There were no cases of meningococcal meningitis or serious infections attributed to encapsulated bacteria. All patients who have already completed the VALIANT study have now enrolled into the VALE long-term extension study. Apellis plans to submit a supplemental new drug application to the U.S. Food and Drug Administration in early 2025. Sobi plans to submit a marketing application with the European Medicines Agency in 2025.

08:32 EDT Travere presents data reinforcing clinical benefit of FILSPARI in IgAN - Travere Therapeutics presented new data further demonstrating the clinical benefit of FILSPARI in IgA nephropathy and reinforcing its potential in focal segmental glomerulosclerosis at the American Society of Nephrology Kidney Week 2024. Key findings from the PROTECT study subgroup analysis of patients with proteinuria above and below 1 g/g: FILSPARI delivered superior proteinuria reduction, and complete proteinuria remission earlier and more frequently compared to irbesartan regardless of baseline UPCR, including those at less than 1.0 g/g. Key Findings from the SPARTAN study evaluating FILSPARI as a first-line therapy: FILSPARI delivered a rapid and sustained reduction in proteinuria of approximately 70% from baseline over 24 weeks in newly diagnosed, RASi-naive patients, and nearly 60% of patients in the SPARTAN study achieved complete remission of proteinuria at any point in time during the treatment period. Throughout the 24 weeks, estimated glomerular filtration rate was stable. Key Findings from the SPARTACUS Study, PROTECT OLE and Real-World Use Evaluating FILSPARI in Combination Therapy for IgAN Interim data from the SPARTACUS Study demonstrated that FILSPARI, when added to stable SGLT2i, was generally well tolerated. Approximately one-third of patients had their proteinuria reduced by at least 50%, and two-thirds of patients by at least 30% when measured after 24 weeks of treatment. Data from the ongoing PROTECT Study open-label extension and real-world use showed favorable safety and additive efficacy results when SGLT2i or immunosuppressants were combined with foundational FILSPARI treatment. Key Findings from the DUPLEX Study Evaluating Sparsentan in Focal Segmental Glomerulosclerosis In a late-breaking presentation from the DUPLEX Study in a subset of patients with genetic mutations in podocyte proteins, a high-risk, treatment resistant FSGS, sparsentan delivered a rapid and sustained proteinuria reduction, including some patients who achieved complete remission and long-term kidney health benefits. An analysis of patient-reported outcomes from 306 adult patients in the DUPLEX Study showed that health-related quality of life for these patients with FSGS on sparsentan was stable over the two-year treatment period, and that patients' burden of kidney disease was improved compared to those receiving irbesartan. Key Findings from the EPPIK Study Evaluating Sparsentan in Rare Proteinuric Disease in Pediatric Patients Preliminary data from the EPPIK Study showed that children with a range of rare proteinuric glomerular disease treated with sparsentan experienced rapid and robust proteinuria reduction of approximately 50% over 12 weeks.