Stockwinners Market Radar for October 03, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:10 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) announced that in the third quarter, the company produced 237,823 vehicles and delivered 241,300. Model S/X production was 8,941 and deliveries were 9,275. Model 3/Y production was 228,882 and deliveries were 232,025. The total subject to operating lease accounting was 7%. Tesla said, "Our delivery count should be viewed as slightly conservative, as we only count a car as delivered if it is transferred to the customer and all paperwork is correct. Final numbers could vary by up to 0.5% or more." 2. The chief executive of the biotech behind the first COVID-19 vaccine has said a new formulation is likely to be needed by the middle of next year to protect against the virus as it mutates, Financial Times' Erika Solomon and Nikou Asgari reported. Ugur Sahin, chief executive of BioNTech, told the Financial Times that as time passes, mutations will emerge that can evade the body's immune defenses. "This year [a different vaccine] is completely unneeded. But by mid next year, it could be a different situation," he predicted. 3. Facebook (FB) shares began September at an all-time high. The company, and stock, have faced a rough stretch since, Max Cherney wrote in this week's edition of Barron's. Facebook now exists in permanent controversy. Yet the stock over a longer period continues to outperform, the author noted. Facebook's business and its stock remain nearly impervious to negative headlines-and there are surely more of those to come, the publication added. 4. Sony's (SONY) "Venom: Let There Be Carnage" won the domestic box office with $90.1M, the biggest three-day launch of the pandemic area. "Venom 2" marks the second-best October launch of all time behind "Joker" two years ago. Back in August, Sony had pushed the movie from September 24 to October 15 amid uncertainty over the delta variant, but when "Shang-Chi" did so well, the studio relocated "Venom 2" to October 1. 5. Cimarex Energy (XEC), Marathon Oil (MRO), Royal Dutch Shell (RDS.A), Meritor (MTOR), Nucor (NUE), Cleveland-Cliffs (CLF), U.S. Steel (X), and Steel Dynamics (STLD) saw positive mentions in this week's edition of Barron's.

15:31 EDT Elbit Systems' medical device spinoff raises $36M - Elbit Systems announced that its subsidiaries, Beyeonics Surgical and Beyeonics Vision, concluded a financing round in an aggregate amount of $36 million. The financing round is comprised of an investment in Beyeonics Surgical and Beyeonics Vision in an aggregate amount of $26 million led by the Italian investment fund TechWald Holding and the Israeli investment fund Alive Israel HealthTech and with participation of the existing shareholders LR Group, XT Hi-Tech, Aurum Ventures and Mivtach Shamir; and a $10 million convertible loan to Beyeonics Vision by global surgical ophthalmic company BVI Medical. Following the investment, Elbit Systems is a minority shareholder in Beyeonics Surgical and Beyeonics Vision.

15:24 EDT Adaptive presents new data demonstrating capability of immune medicine platform - Adaptive Biotechnologies presented new data from three studies demonstrating the potential clinical utility of T-cell testing using T-cell receptor repertoire characterization for infectious diseases during IDWeek 2021, which is being held virtually. Data demonstrate potential advantages over conventional testing methods in SARS-CoV-2 and Lyme disease. In SARS-CoV-2, new real-world data demonstrate that T-Detect COVID can detect prior infection nearly 12 months after diagnosis in some patients. Additionally, T-cell testing can be used to distinguish natural SARS-CoV-2 infection from COVID-19 vaccine response, an important advantage over antibody tests. In Lyme disease, a late-breaking abstract showed TCR repertoire characterization to be nearly two times more sensitive than standard two-tiered testing at identifying individuals with early disease. T cells are the adaptive immune system's first responders to many different diseases and play a critical role in the clearance of pathogens as well as regulating both cellular and antibody-mediated immunity. Given that T cells are highly specific for their disease target and circulate freely in the blood, they are an easy and desirable target for assessing exposure and potential immunity to specific pathogens. A T-cell response can be measured within days from initial pathogen exposure and can persist for years even when antibodies become undetectable. T-cell testing using TCR repertoire characterization can provide a consistent and trackable measure of the immune response to many diseases, such as SARS-CoV-2 and Lyme disease. Data presented at IDWeek suggest that T-cell testing can provide important insights into the SARS-CoV-2 immune response, with potential implications for clinical management, risk stratification, surveillance, assessing protective immunity, and understanding long-term effects. The first study looked at the clinical performance of T-Detect COVID, the first T-cell test available in the U.S. to confirm recent or prior SARS-CoV-2 infection from whole blood samples. Results from this analysis and a real-world evidence data set confirm and extend previously published findings regarding the durability of the detectable T-cell response, from 5 months after an initial positive Reverse Transcription-Polymerase Chain Reaction test result to nearly 12 months in a small number of evaluable patients. Additionally, another study demonstrated that TCR repertoire characterization produced a quantitative picture of the T-cell response to SARS-CoV-2 and demonstrated the ability to distinguish a vaccine response from a natural infection based on the relative absence of T-cell receptors targeting non-spike antigens in vaccinated individuals. Adaptive also presented data at the meeting from a study evaluating TCR repertoire characterization in patients with early Lyme disease, within 30 days from symptom onset. These results demonstrate that T-cell testing using TCR repertoire characterization is nearly two times more sensitive compared to STTT in early Lyme disease and three times more sensitive in the first few days of symptom onset.

15:17 EDT AnaptysBio presents updated data from Imsidolimab Phase 2 GALLOP trial - AnaptysBio announced that week 16 data from the GPP GALLOP Phase 2 trial of imsidolimab, its investigational anti-interleukin-36 receptor therapeutic antibody, was presented at the 2021 European Academy of Dermatology and Venereology Congress. Six of 8 patients treated with imsidolimab monotherapy achieved the primary endpoint of response on the clinical global impression scale at week 4 and week 16, without requiring rescue medication. Two of 8 patients were considered to have not met the primary endpoint because they dropped out of the trial prior to Day 29. Modified Japanese Dermatology Association severity index total score, which incorporates both dermatological and systemic aspects of GPP, decreased on average by 29% at week 1, 54% at week 4 and 58% at week 16. Erythema with pustules, which clinically defines GPP, decreased by 60% at week 1, 94% by week 4 and 98% by week 16. Dermatology Life Quality Index, which is a patient-reported measure, achieved a reduction of 6 points at week 4 and 11 points by week 16, each of which exceeded the minimal clinically importance difference of 4 points. GPP Physician Global Assessment scale was implemented by protocol amendment during the course of the trial and was assessed in 4 of the 8 enrolled patients, where zero or 1 response was achieved in 2 patients at week 4 and 3 patients at week 16. Genotypic testing indicated homozygous wild-type IL-36RN, CARD14 and AP1S3 alleles for all 7 tested patients. Through week 16, anti-drug antibodies were only detected in one patient, which occurred at week 12 and did not impact imsidolimab pharmacokinetics or efficacy. Imsidolimab was generally well-tolerated and most treatment-emergent adverse events were mild to moderate in severity and resolved without sequelae. No infusion or injection site reactions were observed. As previously reported, one patient dropped out of the trial following diagnosis of Staphylococcal aureus bacteremia in the first week, which was a serious adverse event deemed to be possibly drug-related. Because the patient was symptomatic prior to dosing and had a prior medical history of bacteremia, a common comorbidity of GPP, the company does not believe this event is likely attributable to imsidolimab. Another patient dropped out of the study on Day 22 due to investigator reported inadequate efficacy. One patient contracted COVID-19 during the course of the trial, which was mild, unrelated to imsidolimab, and did not lead to study discontinuation.

15:03 EDT Incyte announces full results from Phase 3 TRuE-V evaluating ruxolitinib cream - Incyte announced the full 24-week results from its pivotal Phase 3 TRuE-V clinical trial program investigating ruxolitinib cream, a topical JAK inhibitor, in adolescent and adult patients with nonsegmental vitiligo. Building on the previously announced positive topline results from the TRuE-V program, findings from the Week 24 analysis showed treatment with 1.5% ruxolitinib cream twice daily resulted in greater improvement to vehicle for the primary and all key secondary endpoints in both the TRuE-V1 and TRuE-V2 studies. Results, which were consistent across both studies, showed: At Week 24, 29.9% of patients applying ruxolitinib cream achieved greater than or equal to75% improvement from baseline in the facial Vitiligo Area Scoring Index, the primary endpoint. More than 51% of patients applying ruxolitinib cream achieved greater than or equal to50% improvement from baseline in F-VASI, and more than 15% of patients applying ruxolitinib cream achieved greater than or equal to90% improvement from baseline in F-VASI, key secondary endpoints. Additional key secondary endpoints were met, including a significantly greater proportion of patients achieving greater than or equal to50% improvement from baseline in total body Vitiligo Area Scoring Index and a Vitiligo Noticeability Scale response with application of ruxolitinib cream compared to vehicle, and a significant improvement on percentage change from baseline in facial body surface area with application of ruxolitinib cream compared to vehicle. The overall safety profile of ruxolitinib cream in vitiligo was consistent with previous study data. In the TRuE-V studies, patients using ruxolitinib cream did not report clinically significant application site reactions. Treatment-emergent adverse events were consistent with previous studies, with no serious treatment-related adverse events reported. As previously disclosed, based on these findings Incyte expects to submit marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo to the U.S. Food and Drug Administration and the European Medicines Agency before the end of 2021. In September 2021, Opzelura cream was approved by the FDA for the short-term and non-continuous treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.