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Stockwinners Market Radar for October 10, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
| HON | Hot Stocks20:06 EDT Honeywell forecasts up to 7,400 new business jet deliveries from 2022 to 2031 - Honeywell's 30th annual Global Business Aviation Outlook forecasts up to 7,400 new business jet deliveries worth $238B from 2022 to 2031, up 1% in deliveries from the same 10-year forecast a year ago. In 2021, surveyed business jet operators reported a sharp increase in used jet purchase plans, 12% above last year's report, equivalent to 800 additional used business aircraft. Business aircraft manufacturers also announced a strong increase in jet orders, indicating that the industry has almost completely shaken off the effects of the COVID-19 pandemic. "The increased demand for used jets is estimated at more than 6,500 units over the next five years, putting pressure on an already record low inventory and driving additional demand for new jets," said Heath Patrick, president, Americas Aftermarket, Honeywell Aerospace. "Our latest operator survey results support continued private jet usage growth, as more than 65% of respondents anticipate increased business jet usage in 2022. Despite the ongoing challenges presented by the pandemic, flight hours have recovered and grown beyond pre-pandemic levels. The overall health of the business jet market is strong, and growth is expected to continue."
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| LUV... | Hot Stocks20:02 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. Southwest Airlines (LUV) canceled over 1,800 flights over the weekend, citing bad weather and air-traffic control problems in Florida that rippled throughout its operation, The Wall Street Journal's Alison Sider reported. The airline canceled over 1,000 flights Sunday, or 28% of its schedule, according to FlightAware, a flight tracking site. Over 500 flights were delayed. 2. Apple (AAPL) asked a federal appeals court on Friday to throw out a legal decision that would require the tech giant to tweak its strict App Store rules and force it to allow app developers to inform customers of ways to pay for subscriptions and services outside the App Store, The New York Times' Kellen Browning reported. The September verdict followed a yearlong legal battle between Apple and Epic Games, the maker of the game Fortnite. Apple also asked a judge to delay the ruling mandating App Store changes until after the appeal is heard, the author noted. Changing its rules too quickly, Apple argued, "would upset the careful balance between developers and customers provided by the App Store, and would irreparably harm both Apple and consumers." 3. Everyone has a complaint about Facebook (FB), but there's far less will to force a change, Eric Savitz wrote in this week's edition of Barron's. No question, Facebook continues to receive intense criticism from both sides of the political spectrum, along with growing scrutiny from regulators here and abroad, the author noted. There is growing buzz that Facebook is having a Big Tobacco moment, that Facebook is proving to be toxic, like cigarettes. But for all the buzz, the betting here is that almost nothing will happen, Savitz argued. Further, this past week's service outage could be a reminder of Facebook's staying power, the publication added. 4. "No Time to Die" won the domestic box office with a $56M debut, the fifth-best domestic opening of the pandemic era. The movie had been pushed back three times due to COVID. "No Time to Die" earned an A- CinemaScore from audiences in North America. 5. Gray Television (GTN) and Prudential (PRU) saw positive mentions in this week's edition of Barron's.
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| HAS | Hot Stocks18:55 EDT Hasbro Chairman, CEO Brian Goldner to take medical leave - Hasbro has announced that Brian Goldner is taking a medical leave of absence from his role as CEO, effective immediately. The announcement follows Goldner's disclosure in August 2020 that he was undergoing continued medical care following treatment for cancer in 2014. Rich Stoddart, most recently the Lead Independent Director of Hasbro's Board of Directors, has been appointed as Interim CEO, effective immediately. In conjunction with appointing Stoddart as Interim CEO, Hasbro's Board of Directors has re-appointed Edward Philip as Lead Independent Director, and Tracy Leinbach as Chair of the Nominating, Governance and Social Responsibility Committee of the Board.
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| BGNE | Hot Stocks17:07 EDT BeiGene announces BRUKINSA approved for mantle cell lymphoma in Australia - BeiGene announced that BRUKINSA has been approved in Australia for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy. On October 7, 2021, BRUKINSA received its initial approval in Australia for the treatment of adult patients with Waldenstrom's macroglobulinemia who have received at least one prior therapy or in first line treatment for patients unsuitable for chemo-immunotherapy. Following registration of BRUKINSA with the Australian Therapeutic Goods Administration in both approved indications, these patients will have immediate access to BRUKINSA through the BeiGene sponsored post-approval, pre-reimbursement access program. BeiGene submitted for reimbursement of BRUKINSA to the Australian Pharmaceutical Benefits Advisory Committee, with MCL recommended for listing in July 2021. The Australian registration for BRUKINSA in MCL is based on efficacy results from two single-arm clinical trials. Across both trials, as assessed by independent review committee per 2014 Lugano Classification, BRUKINSA achieved an overall response rate of 83.7%, defined as the combined rate of complete responses and partial responses. In the multicenter Phase 2 trial of zanubrutinib in patients with relapsed or refractory MCL BGB-3111-206, with a median follow-up time of 18.4 months, the ORR was 83.7%, including 68.6% CRs and 15.1% PRs; the median duration of response was 19.5 months. In the global Phase 1/2 trial BGB-3111-AU-003, with a media follow-up time of 14.75 months, the ORR was 84.4%, including 25.0% CRs and 59.4% PRs; the median DoR was 18.5 months. Of the 118 patients with MCL who received at least one prior therapy and received BRUKINSA treatment, 13.6% of patients discontinued treatment due to adverse events in the trials, with the most frequent being pneumonia. Adverse events leading to dose reduction occurred in 3.4% of patients, including hepatitis B, neutropenia, allergic dermatitis, and peripheral sensory neuropathy. The overall safety profile of BRUKINSA is based on pooled data from 779 patients with B-cell malignancies treated with BRUKINSA in clinical trials.
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| FDMT | Hot Stocks16:42 EDT 4D Molecular presents interim results from ongoing 4D-125 Phase 1/2 trial - 4D Molecular Therapeutics announced interim safety and clinical activity data from the Phase 1/2 clinical trial of intravitreal 4D-125 in patients with advanced X-linked retinitis pigmentosa. The data described are from the first-in-human, on-going Phase 1/2 dose escalation and dose expansion clinical trial assessing intravitreal 4D-125, 4DMT's targeted and evolved R100-based product candidate for XLRP. As of the data cutoff date, eight patients with clinically advanced XLRP due to RPGR gene mutation had been enrolled. A standard 3+3 dose escalation design was used, followed by a dose expansion cohort. Patients were enrolled in one of three dose cohorts: dose-escalation cohort 1, dose-escalation cohort 2 and the dose expansion cohort. Patients enrolled in the dose escalation cohorts of the first-in-human clinical trial had clinically-advanced XLRP, with patients having limited or no measurable remaining photoreceptor area or retinal sensitivity. As of the data cutoff date, two dose escalation patients were evaluable for clinical activity defined as having both measurable ellipsoid-zone area by spectral domain optical coherence tomography and retinal sensitivity by microperimetry in both the treated and untreated control eye with at least six months follow-up; dose expansion cohort patients had not yet reached six months follow-up but are expected to be evaluable with sufficient follow up. On-going enrollment in the dose expansion cohort is expected to enroll patients with less advanced disease than those enrolled in dose escalation, and who we expect to be evaluable for clinical activity based on central reading center confirmation at screening. 4D-125 was well-tolerated in all eight XLRP patients, including in five patients at the top dose level of 1E12 vg/eye. No dose-limiting toxicities or serious adverse events were observed. No chronic inflammation was observed.
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| TSLA | Hot Stocks15:46 EDT Tesla CEO says software update should be ready to go 'Sunday or Monday' - Tesla's CEO Elon Musk said via Twitter late Saturday that the company's FSD Beta 10.2 software update should be released Sunday or Monday. "A few last minute concerns about this build. Release likely on Sunday or Monday. Sorry for the delay," the tweet reads. Reference Link
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| RGNX | Hot Stocks15:23 EDT Regenxbio presents initial data from Phase II ALTITUDE trial of RGX-314 - Regenxbio announced initial data from the ongoing Phase II ALTITUDE trial of RGX-314 for the treatment of diabetic retinopathy without center-involved diabetic macular edema using in-office suprachoroidal delivery. ALTITUDE is a multi-center, open-label, randomized, controlled dose-escalation trial that will evaluate the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314 using the SCS Microinjector in patients with a DR diagnosis of moderately severe or severe nonproliferative diabetic retinopathy or mild proliferative diabetic retinopathy. Twenty patients in Cohort 1 were randomized to receive RGX-314 at a dose level of 2.5x1011 genomic copies per eye versus observational control at a 3:1 ratio. Cohort 2 will include 20 patients randomized to receive RGX-314 at an increased dose level of 5x1011 GC/eye versus observational control at a 3:1 ratio. Cohort 3 is designed to evaluate RGX-314 at the same dose level as Cohort 2 in 20 patients who are neutralizing antibody positive. Enrollment is ongoing in Cohorts 2 and 3. Patients in this trial do not receive prophylactic immune suppressive corticosteroid therapy before or after administration of RGX-314. As of September 29, 2021, RGX-314 was reported to be well tolerated in the 15 patients dosed with RGX-314 in Cohort 1. One serious adverse event was reported in one patient dosed with RGX-314, which occurred in the patient's untreated fellow eye and is considered not related to RGX-314. Among patients in Cohort 1 dosed with RGX-314, no intraocular inflammation was observed on slit-lamp examination. One patient experienced a mild case of episcleritis that resolved with topical corticosteroids. Common ocular treatment emergent adverse events in the study eye were not considered drug-related and were predominantly mild. These included conjunctival hemorrhage and conjunctival hyperemia. Of the 15 patients dosed with RGX-314 in Cohort 1, five patients demonstrated a two-step or greater improvement from baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at three months, compared to zero of the five patients in the observational control group. One patient dosed with RGX-314 had a four-step improvement. In the seven patients who had NPDR at baseline, three patients demonstrated a two-step or greater improvement at three months after administration of RGX-314. In the eight patients who had PDR at baseline, two patients demonstrated a two-step or greater improvement at three months after administration of RGX-314.
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| MYOV | Hot Stocks15:18 EDT Enzyvant receives FDA approval for RETHYMIC for pediatric congenital athymia - Enzyvant announced the U.S. Food and Drug Administration approval of RETHYMIC, a one-time regenerative tissue-based therapy for immune reconstitution in pediatric patients with congenital athymia. With this FDA approval, Enzyvant has obtained a Priority Review Voucher under the Rare Pediatric Disease Program. Ten prospective single-arm, open-label studies with patient enrollment from 1993 to 2020 form the basis of the RETHYMIC data set. One hundred and five patients were surgically implanted with RETHYMIC under one of 10 Institutional Review Board-approved protocols. Ninety-five patients were included in the Efficacy Analysis Set and 105 patients were included in the Safety Analysis Set. Survival rates were analyzed with the longest follow-up period of 25.5 years. In the EAS, Kaplan-Meier estimated survival rates were 77% at one year and 76% at two years. For patients who were alive at one year post implantation, the Kaplan-Meier estimated long-term survival rate was 94% at a median follow-up time of 10.7 years. For the patients in the clinical trials, naive T-cell levels were measured using flow cytometry at six, 12, and 24 months after implantation with RETHYMIC. Patients in the clinical trials started out with very few naive T cells but naive CD4+ and CD8+ T cells began to reconstitute over the first year, with a durable increase through year two. Reductions in the number of infections over time during the first two years after treatment were statistically significant. Of the 105 patients in the clinical trials, 29 patients died after receiving RETHYMIC, including 23 deaths in the first year after implantation. Causes of death in the first year included 13 deaths due to infection or complications due to infection, five deaths due to respiratory failure/hypoxia, three deaths due to hemorrhage-related events, and two deaths due to cardiorespiratory arrest. Of the six patients who died more than one year post-implantation, the deaths were considered unrelated to study treatment. Enzyvant is a wholly-owned subsidiary of Sumitovant Biopharma, which is the majority-shareholder of Myovant.
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