Stockwinners Market Radar for September 23, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:02 EDT Point72 reports 5.1% passive stake in Angi Homeservices - Point72 Asset Management disclosed a 5.1% stake in Angi Homeservices, which represents over 3.78M shares. The filing does not allow for activism.

18:44 EDT Anaplan CEO: We're working with companies to provide business agility - In an interview on CNBC's Mad Money, Frank Calderoni said companies are looking for more agility and that is where Anaplan comes into play. "We bring more intelligence into the forecasting process," he said. Google (GOOG, GOOGL) has been a customer since 2016, using Anaplan's (PLAN) products for finance and sales, according to Calderoni.

18:03 EDT Westpac to pay A$1.3B to settle laundering suit with AUSTRAK - Westpac Group has "announced it has reached an agreement with AUSTRAC to resolve the civil proceedings commenced in the Federal Court of Australia on 20 November 2019. Under the agreement, the parties have today, agreed to: file with the Federal Court a Statement of Agreed Facts and Admissions*recommend to the Court that Westpac pay a civil penalty of $1.3 billion in relation to admitted contraventions of the Anti-Money Laundering and Counter-Terrorism and Financing Act 2006. As part of the agreement, Westpac has admitted to additional contraventions that are outlined in the amended statement of claim, and which contribute to the agreed penalty."

17:54 EDT American Outdoor Brands up over 2% after disclosing insider purchase by CEO, CFO

17:45 EDT Green Brick promotes Jed Dolson to COO - Green Brick announced that Jed Dolson has been promoted to COO and executive VP of Green Brick. Dolson previously served as president of the Texas region where he oversaw Green Brick's majority ownership position in Centre Living Homes, total ownership position of CB Jeni Homes, Normandy Homes and Southgate Homes, as well as the launch of Trophy Signature Homes.

17:32 EDT Marcus & Millichap division sells multifamily asset in Phoenix for $90M - Institutional Property Advisors, or IPA, a division of Marcus & Millichap, announced the sale of Liv North Valley, a 385-unit luxury multifamily asset in Phoenix, Arizona. The property sold for $90M, which equates to $233,766 per unit.

17:26 EDT Golub Capital CEO David Golub buys 10,000 shares of company stock - Golub Capital CEO David Golub purchased 10,000 shares of company stock for $13.21 per share between September 21 and September 22 for a total amount of $132,071.

17:22 EDT Amazon, Kratos and Venator Materials awarded on $950M ceiling Air Force contract - Amazon Web Services (AMZN), Kratos (KTOS), Venator Materials (VNTR) and others have been awarded a $950M ceiling in indefinite-delivery/indefinite-quantity contracts to compete for future efforts associated with the maturation, demonstration and proliferation of capability across platforms and domains, leveraging open systems design, modern software and algorithm development in order to enable Joint All Domain Command and Control. These contracts provide for the development and operation of systems as a unified force across all domains in an open architecture family of systems that enables capabilities via multiple integrated platforms. Work will be performed at locations determined at the contract direct order level and is expected to be complete by May 28, 2025. Air Force Life Cycle Management is the contracting activity.

16:57 EDT Arlington Asset Investment CEO buys 100K shares of common stock - In a regulatory filing, Arlington Asset Investment disclosed that its CEO J. Rock Tonkel bought 100K shares of common stock on September 21st in a total transaction size of $267.9K.

16:39 EDT Ulta Beauty suspends planned expansion to Canada - According to a regulatory filing, Ulta Beauty said it has decided to prioritize growth of its U.S. operations and is suspending its planned expansion to Canada. As previously announced, the company has identified investment opportunities to support continued profitable growth in the U.S., including expansion of its omnichannel capabilities; improvements to support guest experience and discovery; market share growth in key merchandising categories; increased loyalty and personalization efforts; and new store openings. Investments to support the expansion into Canada have largely been limited to early-stage infrastructure buildout and lease obligations for a small number of stores. In conjunction with this decision, the company expects to incur costs in the range of $55M-$65M, the majority of which will be recognized in fiscal 2020.

16:30 EDT SeaSpine commercially launches WaveForm C Interbody Implant System - SeaSpine announced the limited commercial launch of its WaveForm C Interbody Implant System. WaveForm C represents the first of five 3D-printed interbody devices that the company anticipates launching by mid-2021. This first limited launch marks the one-year anniversary of the SeaSpine and restor3d exclusive field-based licensing agreement.

16:18 EDT South Jersey Industries announces NJBPU approval for rate changes - South Jersey Industries announced that the New Jersey Board of Public Utilities, or NJBPU, approved changes to its base rates, as well as other rates including those related to the company's accelerated infrastructure programs. These rate changes, combined with those related to the company's basic gas supply service and conservation incentive program rates approved earlier this month are effective October 1 and result in a 14c monthly net bill decrease for the average customer. The base rate change recognizes the investments made since the prior rate case in 2017. With this settlement, South Jersey Gas annual revenues from base rates will increase by $39.5M and include a return on equity of 9.6%, with a 54% common equity component. Customers will experience a net decrease on their bills, as a result of the prudent management of gas commodity costs and changes to other company rates.

16:16 EDT Universal Insurance announces Q3 QTD catastrophe losses of $58M - Universal Insurance announced third quarter-to-date estimated catastrophe losses resulting in full retention events for Hurricane Isaias ($15M, pre-tax, Other States program) and Hurricane Sally ($43M, pre-tax, All States program). These events resulted in a total net impact of approximately $58M, pre-tax (approximately $44M, after-tax).

16:13 EDT SeaSpine announces limited commercial launch of WaveForm C by mid 2021 - SeaSpine Holdings announced the limited commercial launch of its WaveForm C Interbody Implant System. WaveForm C represents the first of five 3D-printed interbody devices that the Company anticipates launching by mid-2021. This first limited launch marks the one-year anniversary of the SeaSpine and restor3d exclusive field-based licensing agreement. "WaveForm technology represents a purpose-driven approach to maximizing patient outcomes in the anterior cervical spine," said Dr. Erik Olsson, Southern Oregon Spine Care. "Every aspect of this interbody was designed to provide efficiency in the procedure for the surgeon and help achieve a successful fusion for the patient. WaveForm C, coupled with OsteoStrand fibers, offers a synergy that is unrivaled in the current interbody and orthobiologics market." The WaveForm C implant offers the next level of 3D-printed architectural innovation, balancing key geometric, manufacturing and clinical requirements. WaveForm C utilizes innovative WaveForm technology to deliver a highly porous and robust interbody solution. WaveForm C features targeted 65% porous endplates* and 75% porous architecture* within the body of the implant. This design is intended to balance subsidence resistance, implant stiffness, and orthobiologics packability, while maintaining radiographic visualization during intraoperative and postoperative imaging.

16:10 EDT Luminex receives $683.5K BARDA award for COVID-19 antibody test enhancement - Luminex has received an award of $683,500 from the Biomedical Advanced Research and Development Authority, or BARDA, part of the Office of the Assistant Secretary for Preparedness and Response within the Department of Health and Human Services, to support the enhancement of the company's xMAP SARS-CoV-2 Multi-Antigen IgG Assay. The company intends to submit this enhanced serology assay for an Emergency Use Authorization when this project is completed. The xMAP SARS-CoV-2 Multi-Antigen IgG Assay detects antibodies to three different viral antigens to assess if a person has been infected with SARS-CoV-2. In this new BARDA-funded project, information from all three of these antigens will be integrated to provide a more comprehensive view of a person's immune status. By combining all of this information in one assay, Luminex seeks to create a test that not only identifies prior infection, but also assesses the neutralizing activity of the immune response. The FDA granted Emergency Use Authorization for this assay on July 20. This project has been funded at approximately 37% of the expected overall cost of development with Federal funds from the Department of Health and Human Services.

16:09 EDT Covenant Logistics provides Q3 update regarding adjusted operating ratio - Executive VP and CFO, Paul Bunn, commented: "The freight environment in the third quarter has been favorable across all of our service offerings, leading to operating results that are exceeding our prior expectations. After reviewing preliminary financial information through the end of August and operating trends through mid-September, we expect to report an adjusted operating ratio(1) in the low 90's as compared to our previously disclosed expectations of an adjusted operating ratio(1) in the mid 90's. We expect freight revenue (which excludes fuel surcharge revenue) to range between $190 million and $200 million, average tractor count to be approximately 2,525 and average freight revenue per tractor per week to be approximately $4,025, for the third quarter of 2020. Our anticipated results reflect sequential and year-over-year improvements attributable primarily to a combination of (1) a significant improvement in freight fundamentals, including increased demand across markets and less industry-wide trucking capacity, (2) a partial recovery of the U.S. economy in the third quarter from the second quarter impact of Covid-19-related business shutdowns and reduction in personal and commercial economic activity, as well as inventory restocking, and (3) reduced overhead and fixed costs related to the ongoing execution of our strategic plan. We are excited about the progress to date and remain focused on continuing to refine the business model so that it is less-cyclical, more sustainable, and operating in higher margin sectors where we can add value to our customers and for our stakeholders."

16:06 EDT Hermitage Offshore trading halted, news pending

16:02 EDT Aspen Technology receives staff determination from Nasdaq - Aspen Technology announced that it received a notice from Nasdaq on September 17, 2020 stating that, as a result of not having timely filed its annual report on Form 10-K for the year ended June 30, 2020, AspenTech is not in compliance with Nasdaq Listing Rule 5250(c)(1), which requires timely filing of periodic financing reports with the Securities and Exchange Commission. The Nasdaq notice has no immediate effect on the listing or trading of AspenTech's common stock on the Nasdaq Global Select Market. Under Nasdaq's listing rules, AspenTech has 60 calendar days from the date of the letter to submit a plan to regain compliance. If the plan is accepted by Nasdaq, AspenTech can be granted an exception of up to 180 calendar days from the original due date of the Form 10-K, or until February 27, 2021, to regain compliance. AspenTech expects to regain compliance within the timeline prescribed. This announcement is made in compliance with Nasdaq Listing Rule 5810(b), which requires prompt disclosure of receipt of a deficiency notification.

15:06 EDT Ormat Technologies VP Krieger buys 3,000 shares of company stock - Ormat Technologies VP Zvi Krieger purchased 3,000 shares of company stock at $55.77 per share on September 22 for a total transaction amount of $167,310.

14:59 EDT Facebook will reject ads that claim election victory before results declared - Andy Stone of Communications at Facebook tweeted: "Facebook will be rejecting political ads that claim victory before the results of the 2020 election have been declared." Reference Link

14:37 EDT California to phase out gasoline-powered cars, reduce fossil fuel demand - California's Governor Gavin Newsom has announced that he will "aggressively move the state further away from its reliance on climate change-causing fossil fuels while retaining and creating jobs and spurring economic growth - he issued an executive order requiring sales of all new passenger vehicles to be zero-emission by 2035 and additional measures to eliminate harmful emissions from the transportation sector." Following the order, the California Air Resources Board will develop regulations to mandate that 100% of in-state sales of new passenger cars and trucks are zero-emission by 2035. In addition, the Air Resources Board will develop regulations to mandate that all operations of medium- and heavy-duty vehicles shall be 100% zero emission by 2045 where feasible, with the mandate going into effect by 2035 for drayage trucks. To ensure needed infrastructure to support zero-emission vehicles, the order requires state agencies, in partnership with the private sector, to accelerate deployment of affordable fueling and charging options. It also requires support of new and used zero-emission vehicle markets to provide broad accessibility to zero-emission vehicles for all Californians. The executive order will not prevent Californians from owning gasoline-powered cars or selling them on the used car market. To protect the health and safety of our communities and workers, the Governor is also asking the Legislature to end the issuance of new hydraulic fracturing permits by 2024. Publicly traded companies in the space include Daimler AG (DDAIF), Fiat Chrysler (FCAU), Ford (F), General Motors (GM), Honda (HMC), Nissan (NSANY), Tesla (TSLA), Toyota (TM) and Volkswagen (VWAGY).Reference Link

13:54 EDT Triumph Group selected by Turkish carrier for wheel services - Triumph Group announced that its Triumph Aviation Services-Asia business was awarded a contract by a Turkish airline to provide aircraft wheel maintenance and repair services for 25 aircraft in its Boeing fleet. TASA is a subsidiary of Triumph Systems & Support located in Chonburi, Thailand. Under the new agreement, TASA will offer a fixed price or 'Power-by-Event' program for the repairs and maintenance services it provides to the unnamed carrier.

13:40 EDT Intel debuts 11th Gen CPUs for edge customers improving IoT - Intel announced new enhanced internet of thing capabilities. The 11th Gen Intel Core processors, Intel Atom x6000E series, and Intel Pentium and Celeron N and J series bring new artificial intelligence , security, functional safety and real-time capabilities to edge customers. With a robust hardware and software portfolio, an unparalleled ecosystem and 15,000 customer deployments globally. "By 2023, up to 70% of all enterprises will process data at the edge.1 11th Gen Intel Core processors, Intel Atom x6000E series, and Intel Pentium and Celeron N and J series processors represent our most significant step forward yet in enhancements for IoT, bringing features that address our customers' current needs, while setting the foundation for capabilities with advancements in AI and 5G."..when combined with 11th Gen's SuperFin process improvements and other enhancements, OpenVINO running on an 11th Gen Core i5 delivers amazing AI performance: up to 2 times faster inferences per second than a prior 8th Gen Core i5-8500 processor when running on just the CPU in each product," said Intel in an earlier statement. Building on the recently announced client processors, 11th Gen Core is enhanced specifically for essential IoT applications that require high-speed processing, computer vision and low-latency deterministic computing. It delivers up to a 23% performance gain in single-thread performance including : Mission-critical control systems, PLC, robotics, industrial PCs and human-machine interfaces;Intelligent, immersive digital signage, interactive kiosks and automated checkout; Next-generation medical imaging devices with high-resolution displays and AI-powered diagnostics; Smart network video recorders with onboard AI inferencing and analytics.

12:58 EDT FirstEnergy down 3% after report of lawsuit from Ohio's Attorney General

12:43 EDT Volkswagen presents the ID.4, its first fully electrically driven SUV - Volkswagen unveiled the ID.4, the company's first fully electrically driven SUV generating zero local emissions and is produced with a carbon-neutral balance. It will be launching into the world's largest market segment, the compact SUV class. "The ID.4 is an emotional all-rounder which will impress many customers with its efficient electric drive, generous amount of space, modern assist systems and powerful design," says Ralf Brandstatter, Chief Executive Officer of Volkswagen brand. "As the first global electric car, this model will roll out our modular electric drive matrix platform that has been developed specifically for electric mobility the world over. Volkswagen is thus once again demonstrating its leading role in innovation, technology and quality on the high-volume market." The ID.4 is an all-round talent that can be driven in a sporty, yet also easy and comfortable way, the company said. The battery stores up to 77 kWh of energy and enables ranges of up to 520 km. It is installed below the passenger compartment which guarantees a low centre of gravity. The electric drive motor, positioned at the rear axle, generates 150 kW - enough to accelerate from 0 to 100 km/h in 8.5 seconds and deliver a top speed of 160 km/h. Thanks to the rear-wheel drive's strong grip and its 21 centimetres of ground clearance, the E-SUV also performs well in gentle off-road terrain, VW added. Reference Link

12:40 EDT PSEG reports New Jersey BPU approval for 'centerpiece' of proposal - The "centerpiece" of Public Service Electric and Gas Co.'s Clean Energy Future proposal was approved today by the New Jersey Board of Public Utilities, or BPU, the company announced. "This decision clears the way for the state's largest utility to commit $1 billion toward energy efficiency investments over the next three years, the largest commitment ever in New Jersey, which is expected to provide environmental benefits and reduce customer bills while creating jobs and boosting the state's economy. Today's action is a vital step toward achieving Gov. Phil Murphy's clean energy vision, propelling New Jersey's economic and environmental sustainability policies to a new level," PSEG stated in a press release regarding the BPU approval.

12:09 EDT Spotify testing new Polls feature for podcasts - Spotify said it is testing a new Polls feature that gives podcasters the opportunity to ask their audience questions within the app. Both the host and listeners will be able to see the responses in real time, opening up an entirely new way for creators and listeners to interact. "Through Polls, listeners can share feedback and opinions as requested by the show's hosts, who can use that information to better connect with their fans in future episodes-whether it's discovering what topics listeners want more of, or learning about the type of guests they love to hear from," the company said. "You can find the poll at the bottom of the episode page for any podcasts where the feature is activated, or on the episode's Now Playing page." Reference Link

12:00 EDT Lithium Americas falls -18.1% - Lithium Americas is down -18.1%, or -$1.63 to $7.41.

12:00 EDT Hilltop Holdings rises 13.5% - Hilltop Holdings is up 13.5%, or $2.46 to $20.65.

12:00 EDT JinkoSolar rises 19.1% - JinkoSolar is up 19.1%, or $5.27 to $32.93.

11:53 EDT Javelin Biotech announces 'organ-on-a-chip' collaboration with Pfizer - Javelin Biotech, a venture-backed company spun out from Dr. Murat Cirit's lab at MIT, announces a three-year collaboration with Pfizer to design and build "what could potentially be an industry-leading platform to evaluate ADME - absorption, distribution, metabolism and excretion - properties of small molecules." Javelin said: "The ADME platform will integrate a microphysiological system (MPS), commonly referred to as "organ-on-a-chip," with interactive computational software to help inform human pharmacokinetic (PK) predictions, a key measure in evaluating new drug candidates in preclinical research. If successful, Javelin plans to commercialize the platform for broad industry adoption; it would potentially be the first 'organ-on-a-chip' system on the market specifically designed for human PK predictions. Under terms of the agreement, the companies will bring together Javelin's in-depth tissue engineering and microfluidics expertise and Pfizer's leading expertise in human PK predictions to create the ADME platform. Javelin will design, build and test the platform, and Pfizer will provide industry guidance for real-world usage, as well as drug and data sets to help validate the platform's predictions." Javelin will retain any potential commercialization rights to the platform. Financial details were not disclosed.

11:04 EDT CPSI, ChartWise partner to offer TruBridge clinical documentation solutions - CPSI and ChartWise Medical Systems announced a partnership that will help healthcare organizations of all sizes improve clinical documentation accuracy and overall medical reimbursement. To strategically manage costs, while also requiring improvements in the quality of patient care, payers continue to shift from fee-for-service to fee-for-value reimbursement models. However, providers struggle with incomplete or inaccurate documentation that often results in incorrect billing, reimbursement and quality reporting. By leveraging the ChartWise computer-assisted CDI software, physicians and clinical documentation specialists have the tools and guidance necessary to improve documentation quality, resulting in reduced claim denials and more accurate reimbursement.

10:15 EDT Wells Fargo CEO apologizes for 'insensitive comment' on diversity - Wells Fargo CEO Charlie Scharf sent a message to all employees today which it also released in a press release. The message reads in part: "Some of you may have seen media stories referencing a comment on diverse talent from my June 'Our commitment to change' memo. I apologize for making an insensitive comment reflecting my own unconscious bias. There are many talented diverse individuals working at Wells Fargo and throughout the financial services industry and I never meant to imply otherwise. I've worked in the financial services industry for many years, and it's clear to me that, across the industry, we have not done enough to improve diversity, especially at senior leadership levels. And there is no question Wells Fargo has to make meaningful progress to increase diverse representation. As I said in June, I have committed that this time must be different..Over the past several months, I have greatly enjoyed and benefited from many conversations with the Black/African American Connection and other Team Member Network affinity groups. I am committed to continuing to listen and learn and appreciate all of your help in driving meaningful change at our company."

10:00 EDT Lithium Americas falls -11.1% - Lithium Americas is down -11.1%, or -$1.00 to $8.04.

10:00 EDT JinkoSolar rises 13.1% - JinkoSolar is up 13.1%, or $3.62 to $31.28.

10:00 EDT Amwell rises 19.0% - Amwell is up 19.0%, or $4.69 to $29.39.

09:47 EDT Lithium Americas falls -7.6% - Lithium Americas is down -7.6%, or -69c to $8.35.

09:47 EDT Aurora Cannabis falls -18.0% - Aurora Cannabis is down -18.0%, or -$1.32 to $6.00.

09:47 EDT Hilltop Holdings rises 12.9% - Hilltop Holdings is up 12.9%, or $2.34 to $20.53.

09:45 EDT Diodes receives approval from China's SAMR for Lite-On acquisition - Diodes Incorporated announced the company has received approval from the China's State Administration for Market Regulation to proceed with its planned acquisition of Lite-On Semiconductor, as announced on August 8, 2019. LSC has initiated the process to terminate its listing on the Taiwan Stock Exchange as of the record date and revoke its public offering with the Taiwan Financial Supervisory Commission. With the exception of the remaining customary closing conditions, all other conditions to the deal's closing have been satisfied, including the approvals from the Taiwan Fair Trade Commission, the Investment Commission of the Ministry of Economic Affairs and China's National Development and Reform Commission and SAMR. Closing is expected to occur by the end of November of this year.

09:26 EDT Microsoft challenges Twilio with launch of Azure Communication Services - Microsoft (MSFT) is challenging Twilio (TWLO) with the launch of Azure Communication Services, a new set of features in its cloud that enable developers to add voice and video calling, chat and text messages to their apps. Reference Link

09:24 EDT Ashford Hospitality shareholder Cygnus Capital issues new letter - Ashford Hospitality stockholder Cygnus Capital, one of its largest stockholders with approximately 7.8% of the company's outstanding common stock, issued another open letter to the company's common stockholders, urging stockholders to vote against all proposals at the company's upcoming special meeting of stockholders on October 6. The letter states that AHT's manager, Ashford, Inc., is conflicted and not aligned with AHT common stockholders, believes multiple unexplored liquidity options exist for AHT, does not believe there is a liquidity emergency at AHT, encourages independent directors of AHT to hire third party advisor to independently review financing and strategic alternatives. Cygnus states, among other things: "In our view, AHT's highly dilutive exchange offers are merely an opportunistic attempt to transfer value from AHT to its insider-controlled manager, and publicly listed company, Ashford, Inc. (...) It is critical that AHT common and preferred stockholders understand that the management team of AHT and AINC are essentially the same. (...) Lismore, a subsidiary of AINC, has been forced upon AHT to renegotiate all the debt of AHT. We believe this entity is yet another construct to create fees to flow from AHT to AINC. (...) It's interesting how the SEC has noticed and begun an investigation into some of these related party transactions. (...) sources show steady recovery in the economy and in the hospitality sector. Even qualitative data is encouraging; schools are reopening, professional sports leagues are restarting, air traffic passenger loads are slowly increasing, restaurants and malls are reopening, businesses are increasingly sending their workers back to offices, and traffic levels are increasing, among other things. (...) Yet, AHT management keeps beating the drum that the company is about to collapse. It won't, in our view, if AINC doesn't keep draining AHT of its cash. (...) At least in the foreseeable future (which could be until there is a vaccine or there is more long term clarity on COVID-19, most lenders are taking a wait and see approach. (...) we believe the preferred stockholders' dividend payments can wait. (...) AINC should immediately hire an independent, third party advisor to solicit and negotiate alternative financing structures. (...) Cygnus Capital has spoken with several parties that would be interested in extending working capital lines and short-term bridge loans to AHT if they are even needed, to preserve the rights and assets of common stockholders. (...) we believe there is time for a formal and non-conflicted third party review to take place".

09:16 EDT PAE to provide COVID-19 testing services for the NCAA Southeastern Conference - PAE was chosen by the Southeastern Conference of the National Collegiate Athletic Association to provide COVID-19 testing services for in-season fall sports at its 14 university locations. Teaming with Premier Medical Group, PAE will deploy trained and ready test teams to each campus for testing and related logistics to support the safe execution of football, soccer, volleyball and other scheduled sports through December 2020 with an option to extend services for playoffs and bowl games. PAE's experience in complex project management and operational logistics is key to meeting the SEC's need for a COVID-19 test provider. Having served on the front lines of the Ebola crisis in Liberia, PAE has the skills, knowledge and capabilities to respond effectively to the current pandemic. President and CEO John Heller said PAE will provide expertise acquired supporting other infectious disease outbreaks on the SEC contract. Notably, the company mobilized and supported Ebola treatment units and a field hospital in Liberia for USAID in 2014 and 2015. PAE's expeditionary skillset will be applied to deploying and managing testing services across the SEC.

09:11 EDT Medtronic announces first enrollments in ALLEVIATE-HF clinical trial - Medtronic announced first enrollments in the ALLEVIATE-HF clinical trial which will evaluate the ability of its Reveal LINQ Insertable Cardiac Monitor in identifying patients at high-risk of worsening heart failure. The trial will determine if early information provided by the LINQ devices enable clinicians to take action before patients' conditions worsen. The LINQ device will alert clinicians if a patient is at high risk for a heart failure event, allowing time for a physician to adjust medications to enhance patient health. The first patients were enrolled at Cardiology Associates of North Mississippi by Dr. Barry Bertolet, and Florida Heart Center by Dr. Prasad Chalasani. The trial is a prospective, randomized, multisite, interventional, investigational device exemption study that will enroll up to 300 patients at up to 30 sites across the United States. Patients will be followed a minimum of seven months and up to three years. With the commencement of the ALLEVIATE-HF trial, Medtronic is the first to study the use of an ICM to manage heart failure in a remote setting.

09:08 EDT Regenxbio slips after Novaris says FDA requested confirmatory study - Shares of Regenxbio (RGNX) are down in pre-market trading after partner Novartis (NVS) announced that it recently received feedback from the U.S. Food and Drug Administration following their review of data from the STRONG study of the intrathecal, or IT, formulation of AVXS-101 in older patients with spinal muscular atrophy, or SMA. The FDA recommends a pivotal confirmatory study to supplement the existing STRONG data and further support the regulatory submission for AVXS-101 IT, Novartis said. Analysts at SVB Leerink have estimated that this additional pivotal study will cause about a two year delay to launch of intrathecal Zolgensma from the firm's previous estimates of approval in early 2022.

09:06 EDT Seelos Therapeutics signs research agreement with Duke University in Parkinson's - Seelos Therapeutics signed a Sponsored Research Agreement with Duke University to use the MPTP-induced Parkinson's Disease mouse model to establish in vivo proof-of-concept study to demonstrate that administration of LV-dCas9-DNMT3A virus can prevent and/or delay PD and test the efficacy and safety of SLS-004. Subsequently, other pre-clinical models would be utilized to further validate the investigational product. Seelos has also begun work on designing a vector capable of inducing and suppressing PD-related phenotypes. The process aims to create a next-generation suppressive unit, carrying a more effective effector molecule than previously used. This research may help to advance a potential tool for reversing SNCA pathologies that can provide a new therapeutic strategy for treating PD.

09:05 EDT BioHiTech Global to supply food waste digesters to Princess Cruises - BioHiTech Global announced it has received an initial purchase order for its Revolution Series Digesters from Princess Cruises, valued at approximately $300,000. BioHiTech's Revolution Series Digesters covered under this purchase order are expected to be delivered for installation on Princess Cruises' 1,780 room ship, Royal Princess in the fourth quarter of 2020. These digesters, equipped with BioHiTech's proprietary data analytics platform, will be utilized as part of a comprehensive plan to limit food waste, achieve safe onboard disposal, and improve associated environmental outcomes.

09:03 EDT Novartis to initiate new pivotal confirmatory study to evaluate AVXS-101 IT - Novartis Gene Therapies recently received feedback from the U.S. Food and Drug Administration following their review of data from the STRONG study of the intrathecal, or IT, formulation of AVXS-101 in older patients with spinal muscular atrophy, or SMA, Novartis announced. "The FDA has acknowledged the potential of AVXS-101 IT in this patient population and recommends a pivotal confirmatory study to supplement the existing STRONG data and further support the regulatory submission for AVXS-101 IT. This guidance provides clarity on the path to registration for AVXS-101 IT. Trial design and other details are being evaluated and a comprehensive update on the overall Novartis SMA clinical development program will be provided at a future time following further discussions with health authorities. This request for a study is unrelated to the partial clinical hold on AVXS-101 IT, and the new study will not be initiated in the US until the hold has been lifted by the FDA. Novartis Gene Therapies remains confident in the overall benefit-risk profile for patients on treatment. This does not impact marketed Zolgensma and the company continues to advance its regulatory filings and intravenous clinical studies," the company stated.

09:02 EDT Urban Tea to acquire 80% interest in Guokui Management - Urban Tea announced that it has entered into a share purchase agreement, pursuant to which the company agreed to pay $400,000 in cash to acquire 80% of the equity interest in Guokui Management. Guokui is incorporated under the laws of New York State and has been operating CROP CIRCLE, a casual street food restaurant in New York City, since August 2020. The Agreement also includes details of how the two parties may collaborate in the future. Upon closing of the transaction contemplated by the Agreement, MYT will own the registered trademark of "CROP CIRCLE" in the United States and operate the Crop Circle restaurant, which features guokui, an oval shaped baked flatbread with various filling selections, a popular street snack originating from northern China's Shaanxi Province. CROP CIRCLE also provides other meals combining classic and modern styles. MYT currently owns the trademark "MENO" and operates MENO, a modern tea and coffee shop with a small curated food menu. The ownership of these two restaurants marks the implementation of MYT's initial brand strategy in the United States. Going forward, the company plans to deepen its roots in the US market based on the restaurants' operating performances.

08:48 EDT Halo Labs signs definitive agreement to acquire Cannafeels - Halo Labs has entered into a definitive share exchange agreement, dated effective September 22 to acquire Cannafeels , pursuant to which the Company will acquire all the issued and outstanding shares of Cannafeels in exchange for common shares of Halo. Cannafeels is a software company developing an online application to provide consumers with relevant, web-sourced and curated information about cannabis strains. The App is currently being developed for both the North American recreational market, as well as the UK and select EU medical cannabis markets.

08:42 EDT Tivity Health adding Walmart and other retail channels to Nutrisystem program - Tivity Health (TVTY) brand Nutrisystem announced the debut of its Body Select program in Walmart (WMT) stores and on Walmart.com. The Nutrisystem Body Select program is designed to work with an individual's distinct body type and includes recommendations for the best approach to weight loss for each body type. Customers can also purchase individual items a la carte. Nutrisystem Body Select can help customers lose up to seven pounds in two weeks* and provides free access to the NuMi app, which matches the customer's Nutrisystem plan to seamlessly track their Nutrisystem foods, Flex Meals, activity, measurements and more. Body Select is sold exclusively through retail channels. Throughout the remainder of 2020, Nutrisystem will expand Body Select into more retail channels including Amazon, Target.com, and select grocery chains.

08:41 EDT General Mills sees increasing market share in North America in Q2

08:40 EDT Plug Power, Universal Hydrogen partner on hydrogen fuel cell propulsion system - Plug Power announced a new partnership with Universal Hydrogen, an end-to-end fuel logistics company making hydrogen-powered commercial flight a near-term reality. Under this partnership, the companies plan to develop, build, and certify a commercially-viable hydrogen fuel cell-based propulsion system designed to power commercial regional aircraft. This initiative is part of Plug Power's strategy to bring its proven hydrogen ProGen fuel cell technology to new markets through engaging leaders in industries such as commercial aviation and aerospace. This partnership also furthers Plug Power's ambitions to build a hydrogen economy. Bringing together Universal Hydrogen's aerospace expertise with Plug Power's fuel cell stack technology and systems capabilities, the partnership aims to certify and fly the world's first 2 megawatt hydrogen-electric aircraft powertrain. The carbon-free propulsion system incorporates a lightweight Plug Power ProGen-based hydrogen fuel cell stack designed for aerospace applications and Universal Hydrogen's modular hydrogen distribution and fuel delivery system. This technology will enable a converted mid-sized regional turboprop aircraft to fly missions up to 1,000 km. This range serves over 90 percent of existing routes, and is far longer than what would be achievable with battery power alone. As part of this program, Universal Hydrogen and Plug Power will integrate and test a full-scale, ground-based powertrain prototype-or iron bird. After a successful ground demonstration, the teams will retrofit the powertrain into the aircraft with flight test completion and regulatory approval under a supplemental type certificate expected by 2024.

08:39 EDT Sinovac's Coronavac approved by NMPA for clinical trials - Sinovac Biotech announced that the inactivated COVID-19 vaccine candidate developed by Sinovac Life Sciences, or "CoronaVac", was approved by the National Medical Products Administration for clinical trial in adolescents and children in August 10th. This randomized, double-blinded, and placebo-controlled phase I/II clinical trial among adolescents and children between the ages of 3-17 years old was approved by the Ethics Committee of the Hebei Provincial CDC on September 11, with the trial expected to commence soon. In this clinical trial, low dosage and medium dosage with two-dose immunization scheduled at 28-day intervals will be adapted. Sinovac has accelerated its vaccine development against the rapid spread of the coronavirus, so as to maximize the safety and health of citizens in China and other select countries around the world. In recent months, the Company's Phase I/II clinical trials of CoronaVac in adults and elderly volunteers were conducted in Jiangsu and Hebei Provinces on April 16th and May 22nd, respectively. The vaccine candidate appeared to be well tolerated for different dosage and no serious vaccine-related adverse events were reported. Both seroconversion rates in adults and elderly volunteers were above 90%, indicating favorable safety and immunogenicity of CoronaVac.

08:38 EDT Surmodics receives FDA clearance for Thrombus Retrieval System - Surmodics announced it has received FDA 510 clearance for its Pounce Thrombus Retrieval System. The Pounce Thrombus Retrieval System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. Depending on the age and magnitude of the occlusion and the viability of the threatened limb, existing treatments for this condition may include catheter directed thrombolysis, surgical embolectomy, and/or percutaneous mechanical thrombectomy. In cases in which the occlusion has caused irreversible damage to the limb, acute limb ischemia can result in the amputation of a lower extremity.

08:35 EDT Myovant Sciences launches 'Forward for Health Equity' grant program - Myovant Sciences announced the launch of its "Forward for Health Equity" grant program. The program will provide funding to nonprofit healthcare organizations with innovative projects focused on improving healthcare access, with an initial focus on reducing racial disparities in prostate cancer and uterine fibroids in the U.S. Myovant will award as many as four grants of up to $50,000 each, for a total of $200,000. Prostate cancer is the second deadliest cancer in men in the U.S. and has the largest racial disparity of any major cancer, killing Black men twice as often as white men. Uterine fibroids can cause debilitating symptoms such as heavy menstrual bleeding and pain, leading to over 250,000 hysterectomies each year in the U.S., with Black women more likely to undergo more invasive surgical procedures. Studies have also shown that Black men and women have less access to healthcare, and access issues such as lack of insurance coverage have been shown to contribute to the racial disparities in prostate cancer and uterine fibroids.

08:34 EDT Luckin gets RMB61M fine from Chinese State Administration for Market Regulation - Luckin Coffee announced the receipt of penalty decisions from the Chinese State Administration for Market Regulation and certain of its sub-bureaus. The SAMR imposed an aggregate fine of RMB61M on two Luckin Coffee entities and certain implicated third-party companies due to their involvement in the fabricated transactions, which the Company disclosed in its press release on April 2, 2020. Pursuant to the Penalty Decisions, the conduct related to the Fabricated Transactions violated the PRC Anti-Unfair Competition Laws. The Company is fully committed to cooperating with the SAMR, and will dedicate all necessary resources to ensure full compliance by the Implicated Companies with the Penalty Decisions.

08:29 EDT SPI Energy launches EdisonFuture subsidiary to develop EV, charging solutions - SPI Energy announced the launch of EdisonFuture, a wholly owned subsidiary of SPI Energy, to design and develop electric vehicles, or EV, and EV charging solutions. EdisonFuture is based at Silicon Valley in Santa Clara, California and complements the company's current suite of PV solutions, including solar and battery storage technologies. EdisonFuture will focus on the design and development of new EV technologies and plans to partner with manufacturers, as necessary.

08:17 EDT Marathon Patent Group engages Gateway to lead investor relations program - Marathon Patent Group has appointed Gateway Investor Relations to provide investor relations and consulting services to the company. Gateway will work closely with Marathon management to develop and deploy a comprehensive capital markets program. Gateway will also assist in organizing non-deal roadshows and securing invitations to select financial conferences for Marathon management over the next 12 months.

08:15 EDT JP Energie Environnement selects First Solar's PV solar modules - First Solar announced that JP Energie Environnement is using its advanced Series 6 photovoltaic solar modules to power the 59-megawatt DC Labarde solar power plant. The facility, believed to be the largest urban solar PV power plant in Europe, is being built on the site of a former open-air municipal landfill in Bordeaux in South West France. The land was designated as a wasteland, unfit for residential or commercial buildings, or agricultural use. JPee, however, secured a 35-year lease for the 600,000-square meter site and began developing the Labarde solar project, which was selected under successive rounds of the PV tenders organized by France's Commission de Regulation De L'Energie. Based in Caen, France, JPee has over 15 years of experience developing, financing, constructing, and operating renewable energy assets. The company operates 263MWDC of wind and solar projects, generating enough energy to power 230,000 average homes, making it one of France's leading independent renewable energy producers.

08:12 EDT CHF Solutions to share COVID-19 experience with government commission - CHF Solutions announced it will be providing testimony to the U.S. International Trade Commission concerning the availability of U.S.-sourced medical supplies to treat COVID-19 and future pandemics. On August 13, 2020, two Congressional committees - the House Committee on Ways and Means and the Senate Committee on Finance - jointly issued a formal request to USITC calling on it to further its investigation into COVID-19 related supply chain challenges and to submit its findings in a report to Congress. This report is widely anticipated to aid Congress in making what the committees term "critical policymaking decisions" concerning U.S. COVID-related industry sectors, including the medical device industry. On Wednesday, September 23, 2020, USITC will hear from industry experts, including Nestor Jaramillo, President and COO of CHF Solutions. In his testimony, Mr. Jaramillo will focus on the need for medical supply security in the U.S., and he will offer CHF Solutions as an example of how U.S.-sourced solutions can rapidly scale to meet critical needs, such as those arising during pandemics like COVID-19. When COVID-19 struck, frontline medical teams quickly realized the pandemic was causing many patients to suffer a complication known as hypervolemia, an overload of fluids resulting from cardiac or renal dysfunction. Unless addressed, hypervolemia causes COVID-19 patients to face a much higher risk of dying due to fluid in their lungs, respiratory failure, kidney injury and failure, septic shock, and multi-system organ failure. Aquadex therapy has been deployed in COVID-19 frontline hospitals as an adjunct therapy for patients afflicted by the pandemic, enabling physicians to treat volume overload before patients succumbed to the ravages of hypervolemia. At the same time, the Aquadex systems also enabled frontline hospitals to free up dialysis equipment and supplies, both of which experienced extreme shortages in COVID-19 hot spots.

08:10 EDT Amazon announces program to make shopping for 'more sustainable products' easier - "Amazon announced Climate Pledge Friendly, a new program to help make it easy for customers to discover and shop for more sustainable products. Customers will now see the Climate Pledge Friendly label when searching for more than 25,000 products to signify that the products have one or more of 19 different sustainability certifications that help preserve the natural world, such as reducing the carbon footprint of shipments to customers," said the company in a statement. Climate Pledge Friendly selection includes grocery, household, fashion, beauty, and personal electronics products, as well as items from a range of other categories-from brands including Seventh Generation, Burt's Bees Baby, and HP Inc. Climate Pledge Friendly products are clearly labeled in shopping results, have additional sustainability information on the product page, and are featured in a dedicated section of our store. Amazon has partnered with trusted third-party certifications, and customers will be able to discover sustainable products that meet sustainability standards that help preserve the natural world. For example, Amazon is partnering with the Cradle to Cradle Products Innovation Institute, a global non-profit dedicated to transforming the safety, health, and sustainability of products. Cradle to Cradle Certified products are safe, sustainable products made to support a circular economy.

08:09 EDT Biocept partner Aegea awarded Japanese patent for Primer-Switch technology - Biocept partner Aegea Biotechnologies, a biotechnology company focusing on the development and commercialization of next generation nucleic acid and clinical diagnostic technologies, has been awarded Japanese Patent. The patent provides intellectual property protection for the Primer-Switch technology, for detecting rare genetic events and for improving real-time PCR amplification reaction as well as associated analysis methods, including next-generation sequencing. This patented technology can also be applied to molecular diagnostic tests for SARS-CoV-2, or COVID-19. The intellectual property underlying the Primer-Switch and the Switch-Blocker technologies is jointly owned by Aegea and Biocept. Under Aegea and Biocept's cross licensing agreement relating to the Primer-Switch and Switch-Blocker intellectual property, Aegea has exclusive rights in the field of infectious disease, and Biocept has certain rights within the field of clinical oncology. Aegea is the sole owner of its 9 other issued US patents and their foreign equivalents. Beyond its use for the detection of rare genetic events, the Primer-Switch technology can be used to enhance the performance and specificity of PCR amplification reactions, which are widely used in molecular diagnostic testing, including COVID-19, and many others.

08:07 EDT ON Semiconductor image sensing technology selected for Subaru ADAS - ON Semiconductor (ON) announced that Subaru (FUJHY) has selected its image sensing technology to enable camera-based advanced driver assistance systems, or ADAS, in the car manufacturer's new-generation EyeSight Driver Assist platform. The Levorg is the first model to offer the new system. The new generation continues the stereo camera architecture, providing a range of ADAS features including adaptive cruise control, lane keep assist and pre-collision braking system. As with previous versions of EyeSight, ON Semiconductor's image sensing technology acts as the 'eyes' to enable this safety functionality. The new-generation Eyesight, recently announced in the Japan market, provides additional features such as active lane change assist and an emergency driver stop system.

08:05 EDT MarketAxess to acquire Regulatory Reporting Hub, terms not disclosed - MarketAxess Holdings (MKTX) has entered into an agreement to acquire the Regulatory Reporting Hub, the regulatory reporting business of Deutsche Borse Group (DBOEY). MarketAxess will acquire the business through Trax NL B.V., its wholly owned subsidiary in the Netherlands. The Regulatory Reporting Hub is a pan-European reporting and compliance platform that enables buy- and sell-side clients to meet their regulatory obligations and transparency requirements across multiple regulations, such as MiFID II and EMIR. Services include transaction and trade reporting, best execution reporting and SI services, as well as APA and ARM services. MarketAxess is already a leading provider of post-trade reporting and pre- and post-trade data services. The acquisition of the Regulatory Reporting Hub will help to further expand and enhance these services across a broader European client base, particularly in Germany, France and the Nordics. The transaction is expected to close in the fourth quarter of 2020, subject to the satisfaction of customary closing conditions. Both MarketAxess and Deutsche Borse commit to a smooth service transition for all customers. The Regulatory Reporting Hub is being sold through Regulatory Services GmbH, a subsidiary of Deutsche Borse Group. The sale of the Regulatory Services GmbH does not affect any other services provided by Deutsche Borse Group.

08:05 EDT Bed Bath & Beyond names Scott Lindblom as Chief Technology Officer - Bed Bath & Beyond (BBBY) has appointed Scott Lindblom as Chief Technology Officer of Bed Bath & Beyond, effective September 28. Lindblom will report directly to John Hartmann, COO and President of buybuy BABY, and will lead the company's enterprise technology transformation. Prior to joining Bed Bath & Beyond, Lindblom was Executive Vice President and Chief Information Officer at Michael's (MIK).

08:03 EDT Maxim Integrated and Serial Microelectronics sign distribution agreement - Maxim Integrated have entered into a distribution agreement with Serial Microelectronics for the distribution of all Maxim Integrated products in China and Hong Kong. The agreement is effective immediately. The strategic partnership between Maxim Integrated and SMHK will provide a brand-new opportunity for both parties in China. Established in 2001, Serial Microelectronics is one of leading authorized distributors of electronic components in the Asia-Pacific region. In 2017, SMHK crossed the $1B revenue mark.

07:39 EDT DraftKings appoints Jocelyn Moore, Valerie Mosley to board of directors - DraftKings announced that the Company's Board of Directors has appointed Jocelyn Moore and Valerie Mosley as new directors effective as of September 23, 2020. Ms. Moore and Ms. Mosley fill two newly created seats on the Board, which will now consist of 15 members. The new board appointments follow DraftKings' recent announcement that Michael Jordan, NBA Hall of Fame inductee, six-time NBA Finals MVP and Chairman of Hornets Sports & Entertainment, will serve as a Special Advisor to the Board. Jocelyn Moore is currently a Venture Partner at Ozone X Ventures in New York and serves as the Executive-in-Residence at The Gathering Spot in Atlanta. Valerie Mosley is the founder and CEO of Upward Wealth, a wealth-tech platform that helps hard-working Americans grow their net worth.

07:36 EDT AGF Management, SAF Group extend partnership for private credit opportunities - AGF Management announced it is accelerating the firm's commitment to its private alternatives business through an expanded partnership with the SAF Group, securing the opportunity to increase its ownership over time. AGF has entered into a definitive option agreement with SAF which grants AGF the right to acquire management fee earnings of select SAF funds, and any new private credit funds, exercisable at any time over the next 12 months. While the extension of AGF and SAF's partnership is initially focused on bringing new investment products to market, including opportunistic funds in late 2020, the option agreement also creates a path forward to a joint private credit firm in the future that is well-positioned to capitalize on the expected growth in private debt investments. Later this year, AGF and SAF expect to initially bring to market a direct lending private credit strategy for institutional and high-net worth investors, with a focus on originating, structuring and lending to middle and lower middle market companies, primarily in Canada and the United States. The General Partner expects to make a capital commitment of $15M to the fund. Subsequently, AGF and SAF will bring to market offerings with varying liquidity and return profiles designed to meet the needs of a wider audience and different segments of the investor market.

07:33 EDT Global Technologies announces acquisition, vendor approval - Global Technologies announced that the Company has taken steps to expand its revenue stream through an acquisition and vendor approval. On September 3, 2020, the Company entered into a Commitment to be Bound by the Amended Operating Agreement to Effect Transfer of Membership Interest in order to facilitate the transfer of 25 Membership Units issued by Global Clean Solutions and held in the name of Graphene Holdings to the Company. In exchange for the transfer of the Units to the Company, the Company issued to Graphene a Convertible Promissory Note in the amount of $250,000. The Note has a term of 6 months, is due on March 3, 2021 and accrues interest at 3% per annum. Upon Closing, the Company holds a twenty-five percent interest in Global. Global is a purpose-built entity with a focus on supplying and facilitating the sale of Personal Protective Equipment. In addition to the sale of masks, gowns and gloves, Global recently released its two proprietary hand sanitizer brands: Purple Mountain Clean, and Blue Sky Pure. In addition, the Company's wholly owned subsidiary, Markets on Main, was recently approved as a product and dropship vendor for one of the largest live home shopping networks in the country. The approval will allow MOM to begin facilitating the fulfillment of packaging and shipping of certain products sold on live airings and through third party websites.

07:32 EDT Lumber Liquidators appoints Alice G. Givens As Chief Legal Officer - Lumber Liquidators appointed Alice Givens as the company's Senior VP, Chief Legal Officer and Corporate Secretary, effective September 21. Givens most recently served as Senior VP, General Counsel, Chief Compliance Officer & Secretary of Ruth's Hospitality Group.

07:17 EDT Selecta Biosciences, Sobi: Phase 3 study of SEL-212 commences - Swedish Orphan Biovitrum AB and Selecta Biosciences announced the commencement of the phase 3 clinical programme of SEL-212 for chronic refractory gout, with the randomisation of the first patient in the study. Sobi has in-licensed SEL-212 from Selecta and will be responsible for development, regulatory and commercial activities in all markets outside of China. The phase 3 programme for SEL-212 is being run by Selecta and funded by Sobi. Topline data from the phase 3 clinical programme is expected in the second half of 2022. Biologics license application filing to the US FDA for SEL-212 is expected in Q1, 2023.

07:14 EDT Clearside Biomedical announces data presentations at The Retina Society 2020 - Clearside Biomedical announced several clinical data presentations were given at the virtual 53rd Annual Scientific Meeting of The Retina Society. Clearside also announced that data from the Company's Phase 2 clinical trial in diabetic macular edema was published in Ophthalmology Retina and can be accessed here. The trial, entitled TYBEE, evaluated the investigational drug XIPERE when used with intravitreally administered aflibercept in patients with DME over a 6-month evaluation period. This early data suggests that, if approved, XIPERE administered suprachoroidally, may have the potential to reduce treatment burden for some patients. Title: Suprachoroidal CLS-AX, as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration. Conclusions: CLS-AX was observed to be well tolerated in all animal species evaluated, with no overt signs of toxicity. There was sustained, high exposure observed in ocular tissues with the highest concentration found in the tissues of the sclera, choroid, and retinal pigment epithelium, followed by the retina. CLS-AX has intrinsic high potency, pan-VEGF inhibition through receptor blockade, and demonstrated prolonged duration observed in pharmacokinetic studies, as well as pharmacodynamic effect in multiple animal models. CLS-AX is intended to be a targeted therapy to affected tissue layers via suprachoroidal injection and has the potential to be a bi-annual therapy for wet AMD. Title: Post Hoc Analysis of Clinical Suprachoroidal Injection Experience Across Indications. Conclusions: To date, this is the most robust aggregate dataset of clinical suprachoroidal injections with mounting evidence pointing to the potential reliability and consistency of the procedure. The results from the retrospective analysis demonstrated the robustness of the suprachoroidal injection regardless of indications. The two needle length options successfully accommodated for anatomical variations across patients. Title: Suprachoroidal Delivery of Small Molecule Suspensions and Nanoparticles Conclusions: Delivery of small molecule suspensions may provide targeted, well-tolerated, and long-acting delivery of a wide variety of pharmacologic agents, including corticosteroids, tyrosine kinase inhibitors, and complement inhibitors to the RPE, sclera and choroid. Preclinical models for these compounds were promising and based on the favorable clinical results of a small molecule corticosteroid for macular edema associated with noninfectious uveitis, further testing is warranted for these other molecules. Additionally, suprachoroidal delivery of DNA nanoparticle-based gene has potential as an office-based retinal gene therapy; and further testing is warranted. Title: Suprachoroidally delivered non-viral DNA nanoparticles transfect chorioretinal cells in non-human primates and rabbits. Conclusions: Suprachoroidal injections of DNA Nanoparticles may address several unmet needs in ocular gene delivery. DNA nanoparticles are relatively non-immunogenic compared to viral vector-based gene therapy, and suprachoroidal injection facilitates the potential for office-based repeat dosing with fewer safety risks compared to subretinal injection via pars plana vitrectomy surgery. In addition, DNA nanoparticles can transfer genes beyond the capacity of viral vectors, including those in common inherited retinal diseases such as Stargardt disease and Usher syndrome. Additional research evaluating suprachoroidal injection in non-human primates and delivery of a therapeutic transgene is needed. Title: Results from the Phase 3 PEACHTREE Clinical Trial: Systemic Therapy and the Efficacy of CLS-TA, a Post-Hoc Analysis. Conclusions: These post hoc results corroborate the pre-specified study analyses in the PEACHTREE trial. With respect to best corrected visual acuity and central subfield thickness, CLS-TA showed a clinically meaningful relative benefit over control in patients receiving systemic immunosuppression and patients not receiving systemic immunosuppression. Title: Correlation of Best Corrected Visual Acuity and Central Subfield Thickness in Macular Edema Due to Retinal Vein Occlusion, Diabetic Retinopathy and Uveitis. Conclusions: In this cohort of over 1,000 eyes, there were moderate baseline relationships between BCVA and CST in patients with macular edema due to retinal vein occlusion, diabetic macular edema (DME) and noninfectious uveitis. There were also moderate relationships between BCVA and CST across these disease states with respect to change from baseline to 6 months. These correlations provide context around the use of CST in clinical decision making.

07:12 EDT Akoustis receives XBAW RF filter design win, order - Akoustis Technologies announced that it has received a design win and pre-production order for band n79 XBAW filters from a new 5G small cell network infrastructure customer. This is the second customer in 5G small cell infrastructure where Akoustis now has more than five active engagements. The new customer has completed sampling of the Akoustis band n79 filter and plans to use the current order to complete qualification and test its new 5G network infrastructure equipment before commercial launch in early calendar 2021. Akoustis is currently shipping two XBAW RF filter designs in band n77 to its first 5G small cell network infrastructure customer. In addition to the two design wins with its first customer, Akoustis has active engagements with numerous tier-1 and tier-2 small cell network equipment OEMs who are currently evaluating the Company's existing band n77 and n79 RF filter solutions. In addition, multiple OEMs have indicated the desire for additional new filters in the sub-6 GHz 5G bands.

07:10 EDT 36Kr Holdings announces strategic collaboration with Youku - 36Kr Holdings announced a business collaboration agreement with Youku Tudou. The collaboration with Youku will help further expand the Company's content ecosystem and accelerate the commercialization of its content productions. Pursuant to the Agreement, 36Kr and Youku will jointly develop pan-commercial themed video programs to enrich the Company's content ecosystem and attract more renowned content creators in the commercial vertical. The integration of 36Kr's stellar content production capabilities and Alibaba's leading presence in digital media and entertainment video offerings coupled with its robust user communities, will further empower the Company to deliver premium business-related content with concentrated exposure while accelerating the monetization of the Company's content offerings.

07:08 EDT General Mills expects Q2 at-home food demand to remain elevated - General Mills continues to expect the largest factor impacting its FY21 performance will be the relative balance of at-home versus away-from-home consumer food demand, driven by the COVID-19 pandemic and resulting global macroeconomic headwinds. Through Q1 of FY21, at-home food demand remained elevated relative to pre-pandemic levels, though it moderated from Q4, as expected, driven by the easing of pandemic-related restrictions and increased restaurant re-openings. The company expects second-quarter at-home food demand to remain elevated compared to pre-pandemic levels, including high single-digit aggregate retail sales growth in General Mills' North America retail categories. The magnitude and duration of elevated at-home food demand remains highly uncertain, and as a result, the company is not currently providing a full-year outlook for fiscal 2021 growth in organic net sales, adjusted operating profit, and adjusted diluted EPS.

07:07 EDT Shopify reports data breach impacting 'less than 200 merchants' - Shopify staff stated in a post to the company's community site last night: "Recently, Shopify became aware of an incident involving the data of less than 200 merchants. We immediately launched an investigation to identify the issue--and impact--so we could take action and notify the affected merchants. Our investigation determined that two rogue members of our support team were engaged in a scheme to obtain customer transactional records of certain merchants. We immediately terminated these individuals' access to our Shopify network and referred the incident to law enforcement. We are currently working with the FBI and other international agencies in their investigation of these criminal acts. While we do not have evidence of the data being utilized, we are in the early stages of the investigation and will be updating affected merchants as relevant. This incident was not the result of a technical vulnerability in our platform, and the vast majority of merchants using Shopify are not affected. However, those whose stores were illegitimately accessed may have had customer data exposed. This data includes basic contact information, such as email, name, and address, as well as order details, like products and services purchased. Complete payment card numbers or other sensitive personal or financial information were not part of this incident. Our teams have been in close communication with affected merchants to help them navigate this issue and address any of their concerns. We don't take these events lightly at Shopify. We have zero tolerance for platform abuse and will take action to preserve the confidence of our community and the integrity of our product." Reference Link

07:05 EDT FDA accepts sNDA for Pfizer's Xalkori for pediatric patients with ALCL - Pfizer announced that the U.S. Food and Drug Administration, FDA, has accepted and granted priority review to the Company's supplemental New Drug Application for XALKORI for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase positive. XALKORI received Breakthrough Therapy designation for the ALK-positive ALCL indication in May 2018 and if approved, would be the first biomarker-driven therapy for this type of pediatric lymphoma. The Prescription Drug User Fee Act, PDUFA, goal date for a decision by the FDA is January 2020. "Despite high survival rates for children with ALK-positive anaplastic large cell lymphoma, many will relapse, requiring novel treatment approaches," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. "Today's FDA filing exemplifies Pfizer's commitment to broadening the use of biomarker-driven therapies in areas with significant needs, such as rare, pediatric cancers. Given XALKORI's proven efficacy in ALK-positive lung cancer and activity seen in clinical trials investigating relapsed or refractory ALK- and ROS-1 positive anaplastic large cell lymphoma, if approved, XALKORI could represent an important step toward improving outcomes for children with this type of cancer."

07:04 EDT Bio-Techne's ExoDx prostate test shows predictive capacity in published study - Bio-Techne announced publication in BMC Urology demonstrating that using the ExoDx Prostate test, or EPI, resulted in "good performance" ruling out high-grade prostate cancer in prior negative biopsy patients with the previously validated 15.6 cut point that was developed on an initial biopsy cohort. The EPI test yielded a negative predictive value of 92% independent of other clinical features and would have avoided 27% of unnecessary prostate biopsies in men while missing only five patients with HGPCa. Initial prostate biopsy often fails to identify prostate cancer, resulting in patient anxiety especially when clinical features such as prostate specific antigen remain elevated, and leading to the need for repeat biopsies.

07:03 EDT Ion Geophysical commercializes Gemini extended frequency source technology - Ion Geophysical announced the commercialization of its proprietary Gemini extended frequency source technology following a successful survey deployment in the Gulf of Mexico. Developed with support from an E&P operator, the new source technology addresses industry demand for increased geophysical fidelity in complex geologies while satisfying both improved operational and environmental performance. Gemini is flexible across both seabed and towed streamer data acquisition platforms and is immediately available as a plug-in component to existing source infrastructure.

07:01 EDT KKR to acquire 1-800 Contacts from AEA Investors, terms not disclosed - 1-800 Contacts announced a definitive agreement under which KKR will acquire the company from AEA Investors. The sale follows many years of strong growth and technology innovation for the vision brand, which was purchased by AEA Investors in 2016. Financial terms of the transaction were not disclosed

06:57 EDT LabCorp launches new test for non-small cell lung cancer - LabCorp has launched a new, non-invasive test for patients with non-small cell lung cancer. Resolution ctDx Lung is a fast and accurate liquid biopsy test that was developed and will be run by Resolution Bioscience. The test is performed on a standard blood sample and detects actionable mutations in genes associated with NSCLC, providing valuable information to help select the most effective targeted treatments for individual patients. The test is covered by Medicare.

06:51 EDT Johnson & Johnson initiates global Phase 3 trial of COVID-19 vaccine candidate - Johnson & Johnson announced the launch of its large-scale, pivotal, multi-country Phase 3 ENSEMBLE trial for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows interim results from the company's Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development, the company said. These results have been submitted to medRxiv and are due to be published online. Based on these results and following discussions with the FDA, ENSEMBLE will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19. Johnson & Johnson has continued the scaling up of its manufacturing capacity and remains on track to meet its goal of providing 1B doses of a vaccine each year, J&J stated.

06:44 EDT United Wholesale Mortgage to become public through Gores Holdings IV combination - United Wholesale Mortgage and Gores Holdings IV, a special purpose acquisition company sponsored by an affiliate of The Gores Group, announced that they have entered into a definitive agreement with respect to a business combination. Upon completion of the proposed transaction, the combined company will operate under the UWM name and the Class A common stock will be listed on NASDAQ under the new ticker symbol (UWMC). The transaction values UWM at approximately $16.1B, or 9.5x the company's estimated 2021 adjusted net income of approximately $1.7B. Founded in 1986 and based in Pontiac, Michigan, UWM is a wholesale mortgage originator in the United States with nearly 7,000 dedicated team members. UWM's differentiated business model focuses exclusively on providing wholesale mortgage clients superior service through proprietary technology. The combined company will have an equity value of approximately $16.1B at closing, making it the largest business combination for a special purpose acquisition company to date. Along with approximately $425M in cash held in Gores Holdings IV's trust account, additional investors have committed to participate in the proposed business combination via a $500M private placement, led by Alec Gores, chairman and CEO of The Gores Group, and including large institutional investors. Upon completion of the transaction, including the private placement, the current owners of UWM will retain approximately 94% ownership of the combined company. The existing management team, led by long-standing president and CEO Mat Ishbia, will continue to lead the business. The proposed transaction will be effected pursuant to the business combination agreement, entered into by and among Gores Holdings IV, United Wholesale Mortgage and the other parties thereto. Concurrently with the consummation of the proposed business combination, additional investors will purchase shares of common stock of Gores Holdings IV in a private placement. After giving effect to any redemptions by the public stockholders of Gores Holdings IV, the balance of the approximately $425M in cash held in Gores Holdings IV's trust account, together with the $500M in private placement proceeds, will be used to pay cash consideration to the newly formed holding company that will own 100% of the company, as well as to pay transaction expenses. The proposed business combination has been unanimously approved by the boards of directors of both Gores Holdings IV and the company, and is expected to close in Q4, subject to customary closing conditions, including the receipt of regulatory approvals, and approval of the stockholders of Gores Holdings IV. Upon closing of the proposed business combination, the name of Gores Holdings IV will be changed to UWM Corporation.

06:34 EDT MediciNova's intranasal COVID-19 vaccine prototype induces antibodies in mice - MediciNova's intranasal SARS-CoV-2 vaccine prototype for COVID-19, using BC-PIV technology, induced systemic serum IgG and mucosal IgA neutralizing antibodies against the S1 antigen of SARS-CoV-2 in mice. A mouse model study was conducted to assess systemic IgG and mucosal IgA antibody production against S1 Ag after intranasal vaccination with MediciNova's BC-PIV SARS-CoV-2 vaccine prototype. THe company confirmed a high IgA antibody titer against S1 Ag in the nasal lavage fluid from mice given intranasal BC-PIV SARS-CoV-2 vaccine and also confirmed that a high IgG antibody titer against S1 Ag was induced in mice serum. BC-PIV, an innovative non-transmissible viral vector co-developed by BioComo and Mie University, is derived from the recombinant human parainfluenza virus type 2. It is efficient in its ability to transfer multiple foreign proteins to recipients and no secondary infectious virus is produced. The BC-PIV SARS-COV-2 vaccine can be developed as an intranasal vaccine in addition to an intramuscular injection because of its high affinity to nasal and upper respiratory tract mucosa, which is the same route of the natural infection of SARS-CoV-2.

06:33 EDT Babcock & Wilcox announces contracts totaling more than $15M - Babcock & Wilcox announced that its B&W Thermal segment will design and supply industry leading low-NOx combustion technology and an innovative pulverizer system upgrade for Taiwan Power Company's Taichung Power Plant in Longjing District, Taichung, Taiwan. The contracts total more than $15M. Four of the plant's boilers were supplied by B&W in the 1990s. B&W Thermal will upgrade the combustion system for one unit, providing its custom-engineered AireJet low-NOx burners. B&W Thermal's AireJet burners offer significantly reduced nitrogen oxides levels compared to other low-NOx combustion technology, burning cleaner, with high boiler efficiency and improved plant heat rate. B&W Thermal will also convert the existing pulverizer systems on two units from B&W-89 to B&W-92 pulverizers to provide additional fuel grinding capability and efficiency, and will also provide DSVS rotating classifiers and associated equipment as part of these pulverizer system upgrades.

06:17 EDT Hilltop Holdings begins modified Dutch auction tender offer for up to $350M - Hilltop Holdings has commenced a modified "Dutch auction" tender offer to purchase for cash up to $350.0M of its common stock at a price per share not less than $18.25 and not greater than $21.00, less any applicable withholding taxes and without interest, using available cash on hand. On September 22, the closing price of the Common Stock was $18.19 per share. The Tender Offer will expire at the end of October 30, unless extended or terminated. If the Tender Offer is fully subscribed, the company will purchase between 16,666,666 shares and 19,178,082 shares, or between 18.5% and 21.3%, respectively, of the company's outstanding Common Stock. Any shares tendered may be withdrawn prior to expiration of the Tender Offer. All shares accepted in the Tender Offer will be purchased at the same price even if tendered at a lower price.

06:15 EDT Cellcom Israel reports controlling shareholder announcement - Cellcom Israel announced that its indirect controlling shareholder, Discount Investment, or DIC, announced that the debenture holders of certain debentures series of IDB Development, or IDB, a company controlled by the company's controlling shareholder, resolved to call for the immediate repayment of the full outstanding balance of certain of IDB's debentures, to enforce the pledges provided in favor of IDB debenture holders, including the pledge on DIC's shares and filed motions to the court for the appointment of a receiver to that end. Additional motion was filed to the court by holders of another series of IDB debentures to take certain receivership actions against IDB. All motions are based on the Israeli Bankruptcy and Economic Rehabilitation Law, 2018.

06:12 EDT Zynga Launches Harry Potter: Puzzles & Spells worldwide - Zynga (ZNGA) announced that its magical Match-3 mobile game Harry Potter: Puzzles & Spells has officially launched and begun rolling out to territories worldwide. Officially licensed from Warner Bros. Games and published under the Portkey Games label, the game is available for free download on Android and iOS devices, as well as on Amazon (AMZN) Kindle and Facebook (FB).

06:08 EDT Fortis announces five-year capital investment plan of $19.6B - Fortis announced its new five-year capital investment plan of $19.6B for the period 2021 to 2025, up $800M from the prior year's plan. Consolidated rate base is projected to increase from $30.2B in 2020 to $36.4B in 2023 and $40.3B in 2025, translating into three and five-year compound annual growth rates of 6.5% and 6.0%, respectively. "With nearly $20 billion of capital planned over the next five years, our customers will continue to benefit from the safe, reliable and affordable service we provide," said Barry Perry, President and CEO, Fortis. "The new five-year plan supports our investment-grade credit ratings and dividend growth, providing stability for our shareholders."

06:07 EDT Fortis raises quarterly dividend 5.8% - The Board declared a common share dividend of 50.5c per share on the issued and outstanding fully paid common shares of the Corporation, representing a 5.8% increase in the quarterly dividend, payable on December 1 to the common Shareholders of Record at the close of business on November 18. In addition, the Corporation has extended its targeted average annual dividend per common share growth of approximately 6% to 2025 based on a 2020 annualized dividend of $1.91. Effective December 1, 2020, the 2% discount offered on common share issuances under the dividend reinvestment plan will be reinstated.

06:03 EDT Lion Electric to deliver 10 battery electric trucks to Amazon - Lion Electric announced that it will deliver 10 battery electric trucks to Amazon and the first two will be delivered this year. Amazon plans to use Lion's trucks in its middle mile trucking operations, which transports items within the company's network. The addition of these battery electric trucks to Amazon's fleet will help the company deliver on its goal of decarbonizing its transportation operations in support of the climate pledge. As part of the delivery, Lion will provide a one-time training to Amazon and the drivers who will operate the trucks upon delivery of the vehicles. They will also establish a maintenance program for the trucks, as part of Lion's expanding network of experience centers. The trucks will be manufactured at Lion's Canadian facility, which has a current capacity to produce 2,500 electric trucks per year. Lion is also planning to open a larger manufacturing facility in the U.S. in the foreseeable future.

06:02 EDT Athersys: MultiStem cell therapy granted RMAT designation from FDA - Athersys announced that MultiStem cell therapy was granted Regenerative Medicine Advanced Therapy designation from the U.S. FDA for the acute respiratory distress syndrome program. The RMAT designation enables sponsors to work closely with the FDA and receive their guidance on expediting development of their products, including providing advice on generating the evidence needed to support approval in an efficient manner. RMAT designation invites the Company to schedule a Type B meeting with the FDA to discuss multidisciplinary strategic development plans, including expediting manufacturing development for commercialization to support priority review and/or accelerated approval.

05:39 EDT Bluebird Bio announces LentiGlobin granted PRIME program eligibility by EMA - Bluebird Bio announced that its investigational treatment for sickle cell disease, or SCD, LentiGlobin for SCD gene therapy, was granted eligibility to the Priority Medicines, or PRIME, program by the European Medicines Agency, or EMA. The EMA's PRIME initiative provides enhanced support and increased interaction to companies, with the goal of optimizing development plans and speeding regulatory evaluations to potentially bring innovative medicines to patients more quickly. To be accepted for PRIME, a therapy must demonstrate potential to benefit patients with unmet medical need through early clinical data. Clinical data from the completed Phase 1/2 HGB-205 study, the ongoing Phase 1/2 HGB-206 study and ongoing long-term safety and efficacy follow-up study LTF-303 supported the PRIME application for LentiGlobin for SCD.

05:35 EDT RingCentral launches in Germany with new datacenter, office - RingCentral announced that its unified communications platform including team messaging, video meetings and cloud phone system will now be available in Germany with a new datacenter in Frankfurt, and a new office in Hamburg, Germany. As RingCentral continues its expansion efforts, Germany remains a strategic location for the company. The new datacenter will also give users access to local phone numbers and emergency services in compliance with local laws and regulations. RingCentral will offer customers local data storage, the ability to register endpoints in-country, and keep voice and video call media local. The new datacenter will also give users access to local phone numbers and emergency services in compliance with local laws and regulation. All team messaging, voicemails, audio and video recordings, call logs, faxes and analytics data will also be stored locally.

05:29 EDT Fiat Chrysler announces Groupe PSA to repurchase 10M shares of Peugeot from DFG - Fiat Chrysler (FCAU) informed that Groupe PSA announced that it is repurchasing 10M common shares of Peugeot (PUGOY) from Dongfeng Motor Group, or DFG. The acquired PSA Shares, representing approximately 1.10% of the share capital of Peugeot., will be cancelled after the settlement of the transaction. In addition, subject to final approval by the board of DFG, Groupe PSA and DFG have agreed to amend the share repurchase agreement in force among them to provide that the remaining 20.7M PSA Shares to be sold pursuant to the share repurchase agreement will be sold by DFG to Groupe PSA by December 31 or, if not sold to Groupe PSA by that date, to third parties by the end of 2022. FCA is providing this information in connection with the proposed combination of FCA and Groupe PSA announced on December 18, 2019.

05:19 EDT Walmart addresses changing needs for upcoming holiday shopping season - Walmart announced how it plans to address three shopping trends expected for this holiday season: an increase in online shopping, evolving wish lists and the need for a safe shopping experience. To prepare for an expected increase in online shopping this holiday season, Walmart will hire more than 20,000 seasonal associates in its e-commerce fulfillment centers across the country. Seasonal employment will begin immediately upon hiring, with shifts scheduled as quickly as 48 hours from applying, and continue through January 1, 2021. In many instances, these positions will have the opportunity to convert to regular employment. These seasonal positions in Walmart's e-commerce fulfillment centers follow the company's hiring of more than 500,000 new associates since March across its stores and supply chain to ensure the retailer could provide essential items to customers during the COVID-19 pandemic. With these new hires over the last six months, its new seasonal associates, and ongoing hiring of full-time and part-time positions as needed in its stores, Walmart said it will be staffed and ready to serve customers for the holiday season. As customer shopping habits have changed over the past six months, the retailer is increasing availability of unexpected holiday gifts that reflect lifestyles in this "new normal," including athleisure, loungewear and sleepwear, outdoor grills, bicycles and exercise equipment and outdoor sporting equipment. And, Walmart has increased its assortment and supply of pet products in its stores and online and is ready to sell over 3M pet beds. Walmart has increased inventory in electronics, with a focus on TVs, laptops and video games. Walmart will have over 1,300 new toys, including puzzles, games and Legos, and more than 800 Walmart-exclusives this holiday season. Walmart has expanded its holiday bake center to more of its stores and is increasing availability of popular kitchen appliances, like the KitchenAid Plus Stand Mixer.

05:06 EDT Best Inc., Cainiao Network launch logistics service between China and Malaysia - Best Inc., together with Cainiao Network, announced the launch of an end-to-end logistics service between China and Malaysia, facilitating the growth of cross-border e-commerce and expanding BEST's footprint in the Southeast Asia region. The partnered logistics service will cover customs clearance, sea freight forwarding, overseas warehousing and last-mile delivery, meaning Best Inc. will send e-commerce parcels from cross-border warehouses in China to Malaysia via international shipping and deliver those parcels to consumers directly through its local express network. Best's. integrated solution will streamline cross-border e-commerce and shorten shipping durations, allowing Malaysian consumers to receive parcels as soon as the next day upon clearing customs in Malaysia. Best's current express network in Malaysia is comprised of over 100 last-mile service stations, with future plans to operate 270 stations and seven sortation centers in the next three years. These plans also include the establishment of a flagship smart sortation hub in Kuala Lumpur that will be equipped with technology such as high-speed automatic sorting and scanning. During the region's recent 9.9 sales event, BEST's parcel deliveries tripled in East Malaysia and this is expected to increase significantly during the upcoming Double 11 shopping festival.