Stockwinners Market Radar for February 09, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
SNE... | Hot Stocks19:45 EST Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. Facebook (FB) and the Internal Revenue Service will square off in a U.S. Tax Court case that could cost the social-media giant more than $9B, The Wall Street Journal's Richard Rubin wrote. The trial slated to start in the week ahead caps a nine-year dispute over how Facebook structured its international operations, the report noted, adding that the IRS argues that more of the company's profits should have been taxed at higher rates in the U.S., rather than in the company's Irish subsidiary. Facebook contends that it deserves a refund, the author wrote. 2. The Chinese embassy in Paris urged the French government not to discriminate against Huawei as it selects suppliers for its 5G mobile network, according to Reuters. The U.S. has been trying to convince countries to ban Huawei from their mobile networks, as Washington believes its technology could allow "back doors" for Chinese spying - an allegation denied by Huawei and Beijing, the report added. The Chinese embassy noted in a statement that China had used foreign companies such as Finland's Nokia (NOK) and Sweden's Ericsson (ERIC) to equip its own domestic networks, and that "We do not wish to see the development of European companies in China affected due to discrimination against Huawei and protectionism in France and other European countries." 3. The coronavirus is killing hundreds of people and sickening thousands more, and it is also disrupting the global tech supply chain, Eric Savitz wrote in this week's edition of Barron's. For now, it is nearly impossible to measure coronavirus risk for companies like Apple (AAPL), which is probably more reliant on China for parts, production, and sales than any company not based there, the author noted. But it isn't just Apple at risk, he contended, adding that a Dell Technologies (DELL) spokesperson told him that it is "assessing all options and mitigation plans to help ensure our supply chain remains operational and we're meeting customers' needs." At HP Inc. (HPQ), the story is much the same, Savitz wrote. 4. Sony's (SNE) "Birds of Prey" won the weekend, with a $33.3M debut from 4,236 theaters. This was one of the lowest domestic launches in modern times for a studio superhero pic. The movie also struggled overseas, earning $48M from 78 markets for a global start of $81.3M. "Birds of Prey" sports a B+ CinemaScore and an 80% Rotten Tomatoes rating. 5. FirstCash (FCFS), Kraft Heinz (KHC), and General Motors (GM) saw positive mentions in this week's edition of Barron's, while Tesla (TSLA) was mentioned negatively.
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NSC | Hot Stocks17:51 EST Norfolk Southern reports bridge washout, restores service in Columbia, SC - Norfolk Southern said in an emailed alert: "Norfolk Southern restored the main line to service following the mainline derailment in Columbia, South Carolina; however, a bridge washout, not related to the derailment, has occurred approximately four miles west of the derailment site. NS expects the route between Spartanburg, South Carolina and Columbia, South Carolina subsequently to remain out of service for approximately one week. Norfolk Southern personnel are en route to begin damage assessments. NS is detouring traffic to minimize the delay. Customers with traffic moving through both areas should anticipate a delay of 24 to 48 hours while normal operations are restored. Norfolk Southern will provide updates as conditions change."
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REGN | Hot Stocks08:04 EST Regeneron announces two-year results from Phase 3 PANORAMA evaluating EYLEA - Regeneron Pharmaceuticals announced two-year results from the Phase 3 PANORAMA trial evaluating EYLEA Injection 2 mg in patients with moderately severe to severe non-proliferative diabetic retinopathy. The two-year pre-specified exploratory data demonstrate that untreated moderately severe and severe NPDR can lead to vision-threatening events, which includes vision-threatening complications and center-involved diabetic macular edema. Based on a Kaplan-Meier analysis, more than half of patients in the untreated sham arm developed a VTC or CI-DME within two years of entering the trial, while EYLEA treatment was shown to reduce the likelihood of these vision-threatening events by at least 75%. According to the company, the two-year results also showed a "greater benefit" for EYLEA patients treated at regular intervals compared to patients who received EYLEA treatment less frequently. Per the protocol, the group of trial patients who received EYLEA every 8 weeks in the first year were switched to receive it when their doctor determined they needed it in the second year. The proportion of these patients with a greater than 2-step improvement from baseline in Diabetic Retinopathy Severity Scale scores decreased in the second year. By comparison, in patients who continued to receive EYLEA every 16 weeks, the greater than 2-step DRSS scores remained consistent. In the second year, patients received an average of 1.8 injections in the 8-week/PRN group; a review of data from the independent reading center of investigator PRN decisions suggests that some of these patients may have been under-dosed based on the protocol rules of the trial. Patients in the 16-week group received 2.6 injections in the second year. During the 2-year PANORAMA trial, adverse events were consistent with the known profile of EYLEA. Serious ocular adverse events in the study eye occurred in 2% and 0% of the EYLEA 8-week/PRN and 16-week groups, respectively, and 2% of patients in the sham group. Ocular inflammation occurred in 2% and 1% of patients in the EYLEA treatment groups, respectively, and 1% of patients in the sham group. Anti-platelet trialists' collaboration-defined arterial thromboembolic treatment emergent events occurred in 3% and 6% of patients in the EYLEA treatment groups, respectively, and 5% of patients in the sham group. Also presented was the rationale for high-dose aflibercept clinical trials. A Phase 2 trial evaluating high-dose aflibercept in wet age-related macular degeneration is currently enrolling. Phase 3 trials planned to start in 2020 in wet AMD and DME will evaluate dosing intervals of 12 weeks and longer. The potential use of high-dose aflibercept is currently under clinical development and the safety and efficacy for this use have not been fully evaluated by any regulatory authority.
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KOD | Hot Stocks07:58 EST Kodiak announces additional safety, efficacy, durability data from KSI-301 trial - Kodiak Sciences announced promising safety, efficacy and durability data from the ongoing Phase 1b study of its investigational therapy KSI-301, an intravitreal anti-VEGF antibody biopolymer conjugate, in patients with treatment-naive wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion. "With further maturation of the Phase 1b study, the safety and efficacy of KSI-301 continue to be very encouraging, and we continue to see the potential for KSI-301 to have class-leading durability across all of the common retinal vascular diseases," said Jason Ehrlich, Chief Medical Officer of Kodiak Sciences. "Our belief is that a next-generation biologic should bring nearly all wet AMD and DME patients to a three month or longer dose interval and the majority of RVO patients to a two month or longer interval. In the data presented at Angiogenesis, we observed that 84% of wet AMD eyes and 76% of DME eyes were extended to four months or longer after the last loading doses before receiving their first retreatment. Remarkably, 55% of wet AMD eyes and 64% of DME eyes were extended to six months. In RVO, a disease which typically requires monthly anti-VEGF therapy to achieve the best results, we continued to observe that over half the patients were extended beyond three months after only three loading doses and without receiving retreatment," he added. "Compared to the data previously presented, more patients have been followed for longer intervals. The safety, efficacy, and durability data continue to be robust and are suggesting the potential for KSI-301 to demonstrate a novel Generation 2.0 durability profile," said Victor Perlroth, Chief Executive Officer of Kodiak Sciences. "We are very pleased with what we continue to learn about the clinical performance of KSI-301 in this exploratory study, and we are using the data to thoughtfully design high conviction pivotal studies of KSI-301 in each of the core indications. Our DAZZLE study in wet AMD, where KSI-301 is given on an every three-, four-, or five-month dosing interval, continues to recruit well. We appreciate the strong support from the ophthalmology community of patients and providers, and we look forward to initiating pivotal studies in DME, RVO, and NPDR later this year as part of our accelerating development program for KSI-301."
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ADVM | Hot Stocks07:55 EST Adverum Biotechnologies reports new interim data from Phase 1 trial of ADVM-022 - Adverum Biotechnologies announced new interim clinical data from the OPTIC Phase 1 dose-ranging clinical trial of ADVM-022 intravitreal injection gene therapy. OPTIC includes treatment-experienced patients with wet age-related macular degeneration. For the first time, data was presented from patients in cohort 2 at 24 weeks following treatment with a single intravitreal injection of a three-fold lower dose of ADVM-022 compared to the cohort 1 dose. ADVM-022 demonstrated a robust efficacy signal and evidence of a dose response: Cohort 1: 6 of 6 patients remain rescue-injection-free at a median follow up of 50 weeks, with 3 patients at 52 weeks. Cohort 2: 4 of 6 patients remain rescue-injection-free at 24 weeks at the lower dose. In both cohorts combined, 10 of 12 patients remain rescue-injection-free. For these patients: Vision was generally maintained as demonstrated by stable mean best corrected visual acuity compared to baseline. Retinal anatomy improvements were achieved and maintained as demonstrated by mean central subfield thickness compared to baseline. ADVM-022 continues to demonstrate a favorable safety profile and be well tolerated with no drug-related or procedure-related serious adverse events, no drug-related systemic adverse events, and no adverse events meeting the criteria for dose-limiting toxicities. ADVM-022-related adverse events have been mild to moderate. Low-grade ocular inflammation was commonly reported and was responsive to steroid eye drops.
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MITK | Hot Stocks07:33 EST Mitek appoints Aaron Korsen as Vice President, North American Identity Sales - Mitek Systems announced that Aaron Korsen has been named Senior Vice President, North American Identity Sales. In connection with Korsen's employment, the Board of Directors of the company granted to Korsen options to purchase up to 92,610 shares of the company's common stock. The options have an exercise price of $9.49 per share, the closing price of the company's common stock as quoted on The NASDAQ Stock Market on the grant date. The options vest over four years, with 25% of such options vesting on the first anniversary of the date of grant, with the remaining 75% vesting ratably on a monthly basis thereafter. The options have a ten-year term. The options were granted as an inducement to Korsen to accept employment with the company and were granted in accordance with NASDAQ Listing Rule 5635(c)(4).
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EIX | Hot Stocks07:31 EST Southern California Edison files 2020-22 Wildfire Mitigation Plan - Southern California Edison has filed its proposed 2020-22 Wildfire Mitigation Plan with the California Public Utilities Commission. SCE's multiyear plan builds on the progress made last year to reduce the risk of fire ignitions caused by utility infrastructure. The company's 2020 plan will advance the maturity of SCE's wildfire mitigation capabilities in a number of dimensions. In 2020, SCE proposes to: Install at least 700 circuit miles of covered conductor, reducing ignitions caused by objects that contact distribution power lines or conductor-to-conductor contact; Install fast-acting fuses at more than 3,000 locations; Continue enhanced inspections, applying advances in the company's risk model to prioritize and address the inspection findings for the overhead assets across transmission, sub-transmission, distribution and generation facilities in high fire risk areas; Deploy at least 375 weather stations; Actively identify and trim or remove trees that may pose a risk of falling into power lines; Advance new technologies; Leverage machine learning and analytics, also known as "big data," to improve inspections and automated sensing of electric system and equipment conditions; Engage Access and Functional Needs customers and partner with community-based organizations and community stakeholders to support their resiliency, working with existing philanthropic partners and deploying customer programs for PSPS preparedness, all-hazard awareness and emergency planning. The company will seek opportunities to accelerate efforts beyond the targets in the plan where possible. SCE plans to invest approximately $3.8B to implement the 2020-22 Wildfire Mitigation Plan. To further reduce PSPS impacts this year, the company is rapidly developing circuit-specific plans. For targeted circuits, SCE is applying a multipronged approach that includes: leveraging existing isolation equipment and/or installing additional sectionalization equipment; targeting grid hardening and remediation measures; providing resiliency solutions such as assistance with battery backup generation; pursuing microgrid opportunities where they are feasible. SCE remains committed to providing timely notification to potentially impacted customers, local governments, public safety agencies and the California State Warning Center before, during and after a de-energization event. SCE will continue to work with local governments and public safety agencies, as well as essential service providers and business customers, to refine the program. SCE met or exceeded nearly all the goals in its 2019 Wildfire Mitigation Plan.
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NSC | Hot Stocks07:07 EST Norfolk Southern reports mainline derailment in Columbia, South Carolina - Norfolk Southern said in an emailed alert: "At approximately 1 p.m. EST Friday, Feb. 7, Norfolk Southern experienced a mainline derailment in Columbia, South Carolina, affecting the route between Spartanburg, SC and Columbia, South Carolina. NS has an alternate route which will be used for detours as capacity permits. Customers with traffic moving through this area should anticipate a delay of 24 to 48 hours. Norfolk Southern is in the process of assessing the situation and will provide updates as conditions change."
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