Stockwinners Market Radar for September 22, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:30 EDT Cricut holder Abdiel Capital buys 268.7K shares of common stock - In a regulatory filing, Cricut disclosed that its institutional holder Abdiel Capital bought 268.7K shares of common stock on September 20th in a total transaction size of $8.17M, boosting its stake by about 1%. Shares of Cricut are up 5.7% after-hours.

19:38 EDT Buenaventura announces strike at Uchucchacua Mine - Compania de Minas Buenaventura announced that the local community surrounding the Company's Uchucchacua mine initiated a strike at midnight on September 13, 2021. Mine operations have therefore since been suspended as access has been blocked. However, essential work associated with mine maintenance and functionality, including water drainage, water treatment and tailings dams inspection, continue without interruption.

18:53 EDT Amazon Web Services to open data centers in New Zealand - Amazon Web Services announced plans to open an infrastructure region in Aotearoa New Zealand in 2024. The new AWS Asia Pacific Region will consist of three Availability Zones and join the existing 81 Availability Zones across 25 geographic AWS Regions at launch. The Region will be owned and operated by a local AWS entity in New Zealand. Globally, AWS has announced plans for 24 more Availability Zones and eight more AWS Regions in Australia, India, Indonesia, Israel, Spain, Switzerland, the United Arab Emirates, and the new AWS Region in New Zealand. "AWS supports thousands of organizations across New Zealand in their drive to innovate, succeed, and grow globally. AWS Cloud technology is providing new ways for government to further engage with citizens, for enterprises to innovate for their next phase of growth, and for entrepreneurs to build businesses and compete on a global scale," said Prasad Kalyanaraman, Vice President of Infrastructure Services, AWS. "Our investments reflect AWS's deep and long-term commitment to New Zealand. We are excited to build new world-class infrastructure locally, train New Zealanders with in-demand digital skills, and continue to help local organizations deliver applications that accelerate digital transformation and fuel economic growth." Amazon said it intends to invest NZ$7.5B in New Zealand over the next 15 years through the new AWS Asia Pacific Region, which includes capital expenditures on the construction of data centers, operational expenses such as ongoing utilities and facility costs, and purchases of goods and services from regional businesses.

18:42 EDT Amplitude Healthcare Acquisition Corp stockholders approve Jasper combination - Amplitude Healthcare Acquisition Corp announced that its stockholders voted to approve the previously announced business combination with Jasper Therapeutics and all other proposals presented at AMHC''s special shareholder's meeting held on September 22, 2021.

18:14 EDT Axonics Medtronic provides update on inter partes review proceedings - Axonics (AXNX) announced that the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office has issued final written decisions on three additional Medtronic (MDT) patents that Axonics is contesting. In March 2020, Axonics filed petitions with the PTAB requesting inter partes review to contest the validity of patents Medtronic has alleged to be infringed by Axonics. In September 2020, the PTAB granted Axonics' request and instituted a review of the six Medtronic patents. On September 13, 2021, the PTAB issued its decision with respect to Patent Nos. 7,774,069; 8,626,314, and 8,036,756. Today, the PTAB issued its decision on the three remaining Medtronic patents Axonics is contesting: Patent Nos. 9,821,112 ('112 patent), 8,457,758 ('758 patent); and 8,738,148 ('148 patent). Either party may appeal the IPR decisions to the Director of the Patent & Trademark Office and to the U.S. Court of Appeals for the Federal Circuit. Axonics expects the stay on legal proceedings in the U.S. District Court in the Central District of California to continue until the appeals process is complete. "First and foremost, it is important to understand that the PTAB rulings as to whether the claims in the Medtronic patents are valid or not do not mean that anyone has 'won' anything. When one party suggests that another party is infringing, the other party often asks the PTAB to determine if the claims in the patents are actually valid. This is what Axonics has done and for Medtronic to claim 'victory' is purely posturing. The fact that the PTAB decided to invalidate several claims in Medtronic's '112 patent is a net positive for Axonics. Moreover, we believe the PTAB's narrow construction of the claims in the '758 patent and '148 patent strengthens our non-infringement argument. Axonics remains confident that it does not infringe any Medtronic patents - valid or invalid - and that we will ultimately prevail on the patent claims asserted against us," said Raymond Cohen, CEO of Axonics.

18:05 EDT Yum China and Lavazza to accelerate expansion of Lavazza cafes in China - Yum China and Luigi Lavazza plan to accelerate the expansion of the store network of Lavazza cafes in China through the existing joint venture, aiming to open 1,000 stores by 2025. Together they will inject $200M initially into the joint venture to fund its future growth. In addition, the joint venture is expected to be Lavazza's exclusive distributor in mainland China to introduce more products from Lavazza's global portfolio. In early 2020, Yum China and Lavazza Group formed a joint venture to explore and develop Lavazza cafe concept in China. The joint venture is owned by Yum China and Lavazza with a stake of 65% and 35%, respectively. The first Lavazza flagship store in Shanghai, the first store outside of Italy, opened its doors to customers in April 2020. Sales to Lavazza members accounted for approximately 50% of total sales for the first half of 2021. The next phase of Lavazza store expansion in China is to increase the density of Lavazza cafe network in higher tier cities with a variety of store formats for a wider range of occasions.

17:50 EDT Amazon partners with Billie Eilish over limited-edition Echo Studio - Amazon has teamed up with singer and songwriter Billie Eilish to release a one-of-a-kind, limited-edition Echo Studio, giving fans an immersive way to listen to her sophomore album, Happier Than Ever, on Amazon Music Unlimited. "The new Billie Eilish Limited-Edition Echo Studio is adorned with the album's cover art, with Billie at the forefront against a backdrop of soft beige-hued fabric," the company said. "Echo Studio is perfect for listening to Billie Eilish's latest collection of songs in spatial audio, a multidimensional audio format available to Amazon Music Unlimited subscribers that adds space, clarity, and depth to music, so you hear sound from every direction. The new Billie Eilish Limited-Edition Echo Studio is available for pre-order starting September 22 for $229.99, and will ship to customers in October. Customers will also receive a free six-month subscription to Amazon Music Unlimited with the device." Reference Link

17:36 EDT Salesforce Chairman Marc Benioff sells over $5M in company shares - Salesforce Chairman Marc Benioff disclosed in a filing that he had sold 20,000 shares of company stock at $259.60 per share on September 21, for a total transaction value of $5,191,902.

17:23 EDT Medirom Healthcare jumps 60% to $11.82 after buying ZACC Kabushiki Kaisha

17:20 EDT BlackBerry jumps 10% to $10.49 after Q2 results beat estimates

17:13 EDT BlackBerry COO Tom Eacobacci to leave company on October 29th - Tom Eacobacci, BlackBerry's President and COO, has decided to pursue other opportunities and will leave the company on October 29th

17:10 EDT BlackBerry CEO says 'revenue for all businesses beat expectations' in Q2 - "Revenue for all businesses beat expectations this quarter. The Cyber Security business unit delivered robust sequential billings and revenue growth and the IoT business unit performed well in the face of global chip shortage pressures," said John Chen, Executive Chairman & CEO, BlackBerry. "We are already seeing benefits from establishing the two key business units and are delighted to appoint John Giamatteo as President of Cyber Security. Giamatteo, who was previously President and Chief Revenue Officer at McAfee, adds leading industry expertise. In IoT, design activity for our QNX products remains very strong, demonstrating both our industry leadership position and secular trends, such as ECU consolidation. In Cyber Security we received strong third-party validation of the effectiveness of our AI-driven, prevention-first suite of products, illustrating progress made with recent product launches."

17:06 EDT Yum China accelerating store network expansion to reach 20,000 store milestone - CEO Joey Wat commented, "Yum China has been demonstrating its resiliency and agility during the pandemic. Our core brands KFC and Pizza Hut responded quickly to the situation and delivered solid results over the past 18 months. As we manage risks in the short term, we see plenty of opportunities to grow quickly. We are accelerating our store network expansion to reach our 20,000 store milestone. We will drive growth from our core brands, as well as emerging brands such as Lavazza, which we aim to grow to 1,000 stores by 2025. We will widen our strategic moat by investing in digitalization and supply chain, our key growth enablers. We are committed to and confident in achieving sustainable long-term growth."

17:05 EDT Visa CHRO Jennifer Grant to step down - Visa announced the promotion of Kelly Mahon Tullier to vice chair, chief people and administrative officer and Julie Rottenberg to executive VP, general counsel. Both appointments are effective as of October 1. In her newly created position, Tullier will assume leadership of Visa's people organization in addition to her current responsibilities as corporate secretary and head of global communications and global corporate services. Rottenberg will oversee Visa's global legal and compliance function, expanding upon her promotion earlier this year. Tullier will assume responsibility from Jennifer Grant, Visa's chief human resources officer, or CHRO, since 2018, who has announced her intention to step down at the end of the year. In her new role, Tullier will take on responsibility for the human resources team which includes global talent acquisition and talent management, total rewards, training and development, people operations and employee relations.

17:01 EDT Brixton, Shidler offer to acquire Transcontinental Realty for $44.40 per share - Brixton Capital and The Shidler Group, together the TC Acquisition Group, seek to acquire 100% of the outstanding capital stock of Transcontinental Realty Investors for $44.40 per share in cash. For the last two months TC Acquisition Group has attempted to engage in constructive conversations with the TCI's Board of Directors to discuss how the transaction would benefit all the shareholders of TCI. TC Acquisition Group's efforts have been largely ignored or dismissed by TCI's Board without any apparent effort to understand the value behind TC Acquisition Group's proposal or why a transaction with the TC Acquisition Group would be in the best interest of TCI's shareholders, the group said. TC Acquisition Group reached out again September 21, 2021 to TCI's Board to further communicate the terms of its offer and further detail its proposal. TC Acquisition Group is sharing this information publicly to ensure that all of the shareholders are informed and aware of its offer and the potential to realize meaningful value in the near term. TC Acquisition Group hopes to facilitate a productive discussion and ultimately negotiate a mutually agreeable transaction that is in the best interest of all TCI shareholders. TC Acquisition Group is eager to engage on a friendly basis with the board and management of TCI, however TC Acquisition Group is concerned about the lack of substantive response to the prior four private letters it sent to the TCI Board outlining the proposal. TC Acquisition Group believes its proposal would deliver a meaningful premium to TCI's shareholders that also represents an attractive opportunity for shareholders to obtain immediate liquidity at what TC Acquisition Group believes is a full and fair valuation based on its extensive review of TCI's publicly available information. The $44.40 offer price represents a 48% premium to TCI's year-to-date volume-weighted average stock price of $30.00 and a 28% premium to TCI's last closing stock price of $34.77 as of September 20, 2021. TC Acquisition Group has a strong business interest in TCI and believes that the company is a good strategic fit with its extensive real estate operational and development capabilities. TC Acquisition Group has been following the TCI story and is impressed with the fundamentals underlying the assets in the portfolio. However, TC Acquisition Group believes TCI's ongoing liquidity constraints, near-term cash obligations, complex ownership structure and thinly traded public currency have presented meaningful challenges for management to operate the portfolio to its maximum potential.

16:54 EDT ChargePoint, Wex to expand partnership on EV charging integration - WEX (WEX) and ChargePoint (CHPT) have "announced plans to expand their existing relationship to provide seamless integration of EV charging for mixed fleets that include internal combustion engine vehicles. This expanded global partnership is expected to not only provide customers ready access to the largest public EV charging network for on-route charging needs, but also enable 'depot' and 'at-home' charging along with the means to facilitate employee reimbursement. WEX and ChargePoint intend to offer a robust end-to-end solution to help mixed fleets incorporate on-route, depot and at-home charging solutions including streamlined program enrollment, centralized reporting and billing, real-time data on energy use to support driver reimbursement for commercial electric charging and installation services. The companies expect to offer at-work and fleet depot charging solutions for customers looking to install on-site charging stations at workplace facilities and integrate them into their fleet operations as well as private site charging solutions."

16:50 EDT Ardagh Group declares special cash dividend of $1.25 per share - Ardagh Group (ARD) has declared a special cash dividend of $1.25 per common share, payable on October 12 to shareholders of record on October 4. Under the terms of the exchange offer, Ardagh Group is offering to exchange 2.5 shares of Ardagh Metal Packaging (AMBP) for each Class A common share of Ardagh Group validly tendered and not withdrawn at the closing of the exchange offer. The special cash dividend is separate from, and in addition to, the regular quarterly cash dividend of 15c per share of Ardagh Group payable on October 1 to shareholders of record on September 17.

16:32 EDT Blue Ridge Bankshares installs first electric vehicle charging station - Blue Ridge Bankshares has installed its first branch electric vehicle charging station, located in North Chesterfield, Virginia. Drivers can use the charging station to power up their electric vehicles, free of charge, while they do their banking or visit other local businesses. Blue Ridge Bank partnered with ChargePoint, the world's largest electric vehicle charging network, to install the ChargePoint charger. The bank is also participating in ChargePoint's Smart Charging Infrastructure Pilot Program, which supports electric vehicle adoption in Virginia.

16:30 EDT Facebook CTO Schroepfer to step down, Andrew Bosworth named next CTO - Facebook chief technology officer Mike Schroepfer said in a Facebook post: "After 13 amazing years at Facebook, I have made the decision to step down as Chief Technology Officer and transition to a new part time role as Facebook's first Senior Fellow at the company sometime in 2022. This is a difficult decision because of how much I love Facebook and how excited I am about the future we are building together. This change in role will allow me to dedicate more time to my family and my personal philanthropic efforts while staying deeply connected to the company working on key initiatives including recruiting and developing technical talent and continuing to foster our AI investments in critical technologies like PyTorch. I'm excited that Andrew Bosworth (Boz) will be transitioning into the role of CTO in 2022. Boz created Facebook's AR/VR organization, which was renamed Facebook Reality Labs (FRL) in 2020, where he drives all of Facebook's efforts in augmented reality, virtual reality and consumer hardware across Oculus, Portal, and Facebook Reality Labs Research. These contributions are foundational components of our broader efforts to help build the metaverse. I'm confident and grateful for Boz's leadership and the deep and talented technical bench of leaders we have at the helm. I am extraordinarily proud of what the team has achieved from unleashing the benefits of AI to bringing VR to life and connecting more people around the world through technology. I am honored to be able to continue to support Facebook's exciting future in my role as Senior Fellow." Reference Link

16:28 EDT Eargo target of DOJ criminal investigation, withdraws 2021 guidance - Eargo was informed it is the target of a criminal investigation by the U.S. Department of Justice related to insurance reimbursement claims the company has submitted on behalf of its customers covered by federal employee health plans. Eargo said it is cooperating with the investigation. In addition, the company "intends to work with the government with the objective of validating the process to support any future claims that the company may submit for reimbursement." As previously disclosed, Eargo has been the subject of an ongoing claims audit by an insurance company that is the company's largest third-party payor. The company has been informed by the insurance company that the DOJ is now the principal contact related to the subject matter of the audit. In light of this information, Eargo is withdrawing its financial guidance for the fiscal year ending December 31, 2021.

16:22 EDT Rezolute presents results from natural history study of congenital HI patients - Rezolute presented results from a natural history study designed to quantify the extent of hypoglycemia in congenital hyperinsulinism HI patients on standard of care therapies. The results were presented at the European Society for Paediatric Endocrinology 2021, held virtually September 22-26. The two-week observational study was conducted in 22 patients ages two years old and older with HI of various genetic causes, 15 of whom were on at least one standard of care therapy, including diazoxide and octreotide . The remaining patients were managed by other means . Glucose control was evaluated by continuous glucose monitors for at least two weeks. The mean time in hypoglycemia as measured by CGM for all participants was 1165 and 1101 minutes in weeks 1 and 2, respectively. This included 115 and 91 minutes of severe hypoglycemia . The two-week observational study was conducted in 22 patients ages two years old and older with HI of various genetic causes, 15 of whom were on at least one standard of care therapy, including diazoxide and octreotide . The remaining patients were managed by other means (tube feeds and/or diet). Glucose control was evaluated by continuous glucose monitors for at least two weeks. The mean time in hypoglycemia as measured by CGM for all participants was 1165 and 1101 minutes in weeks 1 and 2, respectively. This included 115 and 91 minutes of severe hypoglycemia . "Cumulative hypoglycemia places patients with congenital HI at risk for adverse clinical outcomes, including developmental delays and permanent neurologic damage," said Davelyn Hood, M.D., Director, Scientific and Patient Affairs at Rezolute. "This natural history study highlighted the extended periods of hypoglycemia regularly experienced by vulnerable pediatric and adult congenital HI patients on currently available therapies, at levels more than three times the magnitude than is recommended for the management of hypoglycemia in diabetes. These results further validate the urgent need to develop innovative new treatments for congenital HI to more effectively treat hypoglycemia and minimize time outside of the recommended blood glucose range, and also highlight the potential role of continuous glucose monitoring to assess glycemic status and responsiveness to therapies." Rezolute is currently enrolling patients into the second cohort of the Phase 2b RIZE study of RZ358, the Company's monoclonal antibody for the treatment of HI, with topline data expected in Q1 of 2022.

16:10 EDT Vertex provides update on proposed acquisition of the mobile refinery - Vertex Energy (VTNR) provided an update on the proposed acquisition of the Mobile refinery located in Mobile, Alabama from Equilon Enterprises a Shell Oil Products US, Shell Oil Company and Shell Chemical subsidiaries of Royal Dutch Shell (RDS.A). The planned transition of commercial operations from Shell to Vertex remains on-schedule. The transaction is currently expected to close during the first quarter 2022, subject to regulatory clearance, financing, and various closing conditions.

16:07 EDT H.B. Fuller reports Q3 adjusted EBITDA up 5% to $111M - Q3 organic revenue was up 13% when compared with the non-COVID-impacted Q3 of 2019.

16:06 EDT Procore to acquire Levelset for roughly $500M - Procore Technologies has signed a definitive agreement to acquire Levelset. This acquisition will add lien rights management to the Procore platform, enabling Procore to manage complex compliance workflows and improve the payment process in construction. It also presents future growth opportunities for Procore, including capitalizing on the companies' complementary data assets. Procore Founder and CEO Tooey Courtemanche said, "Construction work is hard enough - getting paid shouldn't be. Levelset helps the construction industry get paid faster, and their offering will be a perfect addition to the Procore platform. This acquisition will also give Procore access to industry data, including payments and compliance activity, allowing us to deliver valuable risk intelligence to our customers, and to develop innovative financial products." Procore has agreed to acquire Levelset for a purchase price of approximately $500M, which will consist of approximately $425M in cash, subject to customary adjustments for working capital, transaction expenses, cash and indebtedness, and approximately $75M in Procore common stock. The closing of the transaction is anticipated to occur in the fourth quarter of this year and is subject to customary closing conditions.

16:02 EDT FireEye to change its corporate name to Mandiant as of October 4th - FireEye announced that it plans to change its corporate name on Monday, October 4, 2021, and relaunch as Mandiant, Inc. at its annual Cyber Defense Summit 2021. In connection therewith, the Nasdaq ticker symbol for the company's common stock will change to MNDT at the opening of trading on Tuesday, October 5, 2021. The plan to change the corporate name and stock ticker symbol follows the announcement on June 2, 2021 that the company entered into a definitive agreement to sell the FireEye Products business, including the FireEye name, to a consortium led by Symphony Technology Group.

15:31 EDT Medtronic says PTAB rejects more Axonics challenges - Medtronics announced that the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office has affirmed an additional three patents in a dispute with Axonics over intellectual property for its sacral neuromodulation device family, the InterStim systems. Today's decisions complete the review process initiated by Axonics to challenge the validity of the seven total patents involved in the IP infringement case brought by Medtronic. Cumulatively, the PTAB has now affirmed claims in all seven of the Medtronic patents. The PTAB's latest decisions today affirmed all claims at issue in Medtronic's U.S. Patent Nos. 8,457,758 ('758) and 8,738,148 ('148); and affirmed claims 1-7, 16-18 and 22 of Medtronic's U.S. Patent No. 9,821,112 ('112), while invalidating claims 9-13 and 20. These patents relate to recharging technology. Medtronic is weighing its legal options with regard to the handful of invalidated patent claims in the '112 patent. The '758 patent and the '148 patent expire in April 2025, the '112 patent expires in April 2024. Now that the IPR is complete - including the PTAB's decision in September 2020 to reject without hearing the challenge to Medtronic U.S. patent No. 9,463,324 ('324) - Medtronic will request that the U.S. District Court in the Central District of California lift the stay on the IP infringement case and resume proceedings. The decision on the '324 patent is final and not appealable. The '324 patent expires in April 2024. All Medtronic patents affirmed by the PTAB have been in force for every sale Axonics has made to-date. "Medtronic appreciates the Patent Trial and Appeal Board's efforts in this matter," said Brett Wall, executive vice president and president of the Neuroscience Portfolio at Medtronic. "We are pleased with the outcome of the review process and look forward to our day in court to protect the proprietary technology that brings SNM therapy to patients around the world."

15:08 EDT Powell says will take 'appropriate' action if Wells Fargo fails to fix problems - Jerome Powell said the asset cap on Wells Fargo won't be removed until the bank's issues have been resolved, but added that he cannot speak about confidential supervisory assessments related to it and other individual banks. Fed Chair Powell continues to hold a post-FOMC press conference.

13:59 EDT Robinhood spikes over 5% after announcing crypto wallets are coming to the app - Shares of Robinhood are up $2.16 per share or 5.12% to $44.45 per share in afternoon trading on Wednesday after that crypto wallets are coming to the app.

13:14 EDT North American rail traffic dropped 2.8% in week ended September 18 - The Association of American Railroads, AAR reported U.S. rail traffic for the week ending September 18. For this week, total U.S. weekly rail traffic was 505,622 carloads and intermodal units, down 3.1% compared with the same week last year. Total carloads for the week ending September 18 were 234,790 carloads, up 3.5% compared with the same week in 2020, while U.S. weekly intermodal volume was 270,832 containers and trailers, down 8.3% compared to 2020. North American rail volume for the week ending September 18 on 12 reporting U.S., Canadian and Mexican railroads totaled 331,319 carloads, up 1.3% compared with the same week last year, and 359,788 intermodal units, down 6.2% compared with last year. Total combined weekly rail traffic in North America was 691,107 carloads and intermodal units, down 2.8% North American rail volume for the first 37 weeks of 2021 was 25,631,842 carloads and intermodal units, up 8.5% compared with 2020. Publicly traded companies in the space include CSX (CSX), Canadian National (CNI), Canadian Pacific (CP), Kansas City Southern (KSU), Norfolk Southern (NSC), Union Pacific (UNP), Trinity Industries (TRN) Greenbrier (GBX) and FreightCar America (RAIL). Reference Link

13:03 EDT Facebook completes six-month privacy assessment ordered by FTC - Facebook provided an initial six-month assessment of the progress it has made so far under a 20-year order levied by the FTC over oversight and accountability to Facebook's privacy program. "The report recognizes the high level of access and cooperation that we provided throughout the assessment process," Facebook said. "It also calls out our extensive investments in privacy compliance and notes that the scope of our privacy program and the structure we've used to organize it are comprehensive. As a result, the key foundational elements necessary for an effective program are now in place even if some are still developing." As required by the FTC Order, the report also identifies key areas where Facebook can improve its program. These include: Enhancing the Privacy organization's oversight role so it increases its effectiveness as an independent and standard-setting compliance function; Continuing to develop a compliance mindset focused on evaluating risks and controls while evolving existing processes and prioritizing compliance documentation and consistency, and; Bolstering privacy safeguards and controls using technology that builds on the company's core strengths in automation and analytics. "We agree with these focus areas and identified many of the same ones ourselves for further investment," Facebook added. "The report's recommendations are consistent with what one would expect to see for a rapidly evolving, early stage program of this level of complexity." Reference Link

12:41 EDT Toyota announces recall of about 8,400 2022 Prius, Prius Prime vehicles in U.S. - Toyota is conducting a safety recall involving certain 2022 Prius and Prius Prime vehicles in the United States. Approximately 8,400 vehicles are involved in this recall. In the involved vehicles, a software error can cause a control computer to erroneously determine that it does not have the correct information about the transmission position if the position changes during a short window of time when the computer is checking this information. For all involved vehicles, Toyota dealers will update the hybrid vehicle ECU software to correct the programming in the hybrid vehicle ECU's shift monitoring logic. Owners of vehicles will be notified by November 21, 2021. Reference Link

12:39 EDT Incyte says FDA approves Jakafi for treatment of chronic GVHD - Incyte announced that the U.S. Food and Drug Administration has approved Jakafi for treatment of chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. "GVHD is the leading cause of morbidity and mortality in patients following an allogeneic stem cell transplant, yet there historically have been limited treatment options available beyond first-line systemic therapies," stated Steven Stein, M.D., Chief Medical Officer, Incyte. "Incyte is proud to have contributed to the overall scientific understanding of GVHD through our REACH program, which has led to important treatment advances on behalf of patients and the medical community, including today's approval of Jakafi for certain people who develop chronic GVHD." The FDA approval was based on the REACH3 study, a Phase 3, randomized, open-label, multicenter study of Jakafi in comparison to best available therapy for treatment of steroid-refractory chronic GVHD after allogeneic stem cell transplantation. The primary endpoint of overall response rate at Week 24 was 49.7% for Jakafi compared to 25.6% for BAT.

12:25 EDT Epic CEO says 'Fortnite' to be blacklisted from Apple ecosystem - Epic Games CEO Tim Sweeney said via Twitter: "Late last night, Apple (AAPL) informed Epic that Fortnite will be blacklisted from the Apple ecosystem until the exhaustion of all court appeals, which could be as long as a 5-year process." Investors in Epic include Tencent (TCEHY), KKR (KKR), Disney (DIS), and Sony (SONY). Reference Link

12:01 EDT Vicarious Surgical falls -7.6% - Vicarious Surgical is down -7.6%, or -$1.11 to $13.42.

12:00 EDT Rockley Photonics falls -10.6% - Rockley Photonics is down -10.6%, or -$1.18 to $9.95.

12:00 EDT Mechel rises 14.5% - Mechel is up 14.5%, or 51c to $4.03.

11:31 EDT Vertex says Kalydeco supplement submission accepted by Canada - Vertex Pharmaceuticals announced its supplement to a New Drug Submission for Kalydeco has been accepted for priority review by Health Canada for the treatment of cystic fibrosis in patients from 4 months to 18 years of age and weighing at least 5 kg with the R117Hmutation in the cystic fibrosis transmembrane conductance regulator gene.

11:10 EDT Snowflake announces strategic partnership with Citi around data flows - Snowflake (SNOW) and Citi (C) announced a strategic initiative to "re-imagine how data flows across financial services transactions to provide a frictionless solution for post-trade processes across the industry." "This strategic partnership with Citi will address some of the most prevalent data challenges faced by today's financial services organizations in order for them to drive innovation for their customers and grow their business. Snowflake's Financial Services Data Cloud can redefine data experiences for the financial services industry, so data is more connected and flows more seamlessly across industry transactions than previously possible," said Matt Glickman, VP and Global Head of Financial Services Industry at Snowflake. "Clearly, if we were to start afresh, we would not design market transaction data workflows in the way they function today. In partnership with Snowflake, we are striving to provide solutions to the challenge of multiple records across multiple systems and the associated costs and data reconciliation consequences that hinder our clients and the industry today," added Okan Pekin, Global Head of Citi Securities Services.

11:02 EDT Paccar, Aurora and FedEx launch autonomous truck commercial pilot - Paccar (PCAR) announced it has teamed up with Aurora, which it calls "a leading autonomous driving technology company," and FedEx (FDX) to launch a commercial pilot of autonomous trucks in linehaul trucking operations. "This is the first collaboration of its kind between a truck manufacturer, an autonomous technology developer and a logistics provider. Starting today, PACCAR's autonomously enabled trucks configured with the Aurora autonomous Driver will haul FedEx loads between Dallas and Houston, a 500-mile round trip, along the I-45 corridor. The trucks will operate autonomously, with a backup driver for additional safety," Paccar said.

10:31 EDT AT&T CEO sees WarnerMedia-Discovery deal closing in mid-2022 - John Stankey, CEO of AT&T (T), spoke recently at the Goldman Sachs Communacopia Conference, where he provided an update to shareholders. In discussing the company's priorities since he became CEO last year, Stankey said AT&T has now successfully restructured its asset base to position its largest remaining entities - AT&T Communications and WarnerMedia - to better capitalize on the long-term structural tailwinds of each of their respective markets. Following the close of the WarnerMedia-Discovery (DISCA) transaction, Stankey believes AT&T Communications and Warner Bros. Discovery will each have the right scale, capital structure and asset base to lead their respective industries. AT&T continues to deploy fiber across its wired footprint and remains confident in its ability to reach about 2.5 million incremental customer locations passed by the end of 2021. As previously noted, AT&T has experienced some disruption in its supply chain. However, the company now believes this has been addressed and remains comfortable with its long-term guidance to reach 30 million locations by the end of 2025. Stankey indicated that AT&T continues to expect to close the pending WarnerMedia-Discovery transaction in mid-2022. In the interim, AT&T remains focused on expanding HBO Max's global footprint. HBO Max launched in 39 Latin America territories in June and is set to launch in six European countries next month, with plans to launch in at least 14 additional European territories in 2022. AT&T expects HBO Max subscriber growth in the second half of 2021 to primarily come from outside the United States.

10:11 EDT Ensysce Biosciences down 16% after holders register 27M shares of common stock

10:07 EDT Rocket Lab wins contract to launch orbital debris removal demonstration mission - Rocket Lab announced earlier it has signed a dedicated launch contract with Astroscale Japan, a subsidiary of Astroscale Holdings. Scheduled for lift-off from Rocket Lab Launch Complex 1 in 2023, the Electron rocket will launch the Active Debris Removal by Astroscale-Japan, or ADRAS-J, satellite, which has been selected by the Japan Aerospace Exploration Agency, or JAXA, for Phase I of its Commercial Removal of Debris Demonstration Project, or CRD2, one of the world's first technology demonstrations of removing large-scale debris from orbit. Once deployed to a precise orbit by Electron's Kick Stage, the ADRAS-J satellite is designed to rendezvous with a piece of orbital debris, a long abandoned upper stage rocket body. ADRAS-J aims to demonstrate proximity operations and obtain images of the rocket body, delivering observational data to better understand the debris environment. A planned second phase of the mission, which has yet to be competed, intends to demonstrate the de-orbit of the debris. "The ability to actively remove satellites and debris from orbit at the end of their operational life will likely play a key role in ensuring a sustainable space environment for the future," said Rocket Lab Founder and Chief Executive Officer, Peter Beck. "Rendezvousing with a piece of debris on orbit, travelling at around 27,000 km per hour, is a highly complex task that requires absolute precision when it comes to orbital deployment. Electron's Kick Stage has demonstrated this precision across 18 missions, providing in-space transportation to place our customers' satellites exactly where they need to go." Shares of Rocket Lab are up 61c to $15.09.

10:06 EDT Macquarie Infrastructure completes reorganization into limited liability company - Macquarie Infrastructure Holdings, LLC announced the completion of a previously approved corporate reorganization. As a result of the reorganization, Macquarie Infrastructure Corporation is now a subsidiary of Macquarie Infrastructure Holdings, LLC, a limited liability company treated as a partnership for tax purposes. At the close of trading on September 22, 2021, shareholders of Macquarie Infrastructure Corporation will become unitholders of Macquarie Infrastructure Holdings, LLC on a one-for-one basis without an exchange of certificates. Commencing September 23, 2021, units of Macquarie Infrastructure Holdings, LLC will trade on the New York Stock Exchange under the same symbol.

10:01 EDT Medtronic enrolls first patient in BRAIVE IDE study - Medtronic announced that it has enrolled its first patient and completed the first surgical procedure in its BRAIVE IDE study, which will evaluate the safety and effectiveness of the Braive growth modulation system for treatment of progressive Adolescent Idiopathic Scoliosis. The first patient was recruited by The Newcastle Upon Tyne Hospitals NHS Foundation Trust, United Kingdom. The device is Medtronic's latest innovation in the pediatric spine category, and the study's initiation reaffirms the company's commitment to continued innovation for pediatric patients.

10:00 EDT Telus International falls -5.9% - Telus International is down -5.9%, or -$2.17 to $34.80.

10:00 EDT FedEx falls -8.1% - FedEx is down -8.1%, or -$20.32 to $231.75.

10:00 EDT Mechel rises 10.5% - Mechel is up 10.5%, or 37c to $3.89.

09:47 EDT Safehold falls -5.5% - Safehold is down -5.5%, or -$4.41 to $75.15.

09:47 EDT FedEx falls -7.5% - FedEx is down -7.5%, or -$18.96 to $233.11.

09:47 EDT Mechel rises 10.1% - Mechel is up 10.1%, or 35c to $3.88.

09:36 EDT Discovery Communications trading resumes

09:34 EDT Sasol commits to net zero ambition by 2050 - Sasol announced its updated strategy that commits it to be at net zero emissions by 2050. This is in line with Sasol's commitment to accelerate its transition to a low carbon world in support of the objectives of the Paris Agreement. In aligning with its 2050 ambition, Sasol has stepped up its 2030 scope 1 and 2 greenhouse gas emission reduction target, from an initial 10% for its South African operations, announced last year, to 30% for its Energy and Chemicals businesses, off a 2017 baseline. The company is also introducing a scope 3 reduction target, for its Energy Business, off a 2019 baseline. This is consistent with what its peers have committed to. Beyond 2030, Sasol has more than one viable pathway to get to its net zero ambition by 2050, with different options to transform its Southern Africa value chain by progressively shifting its feedstock away from coal, towards more transition gas, and then, green hydrogen and sustainable carbon over the longer term, as economics improve for these options.

09:30 EDT BofA does digital transformation work on 50 weekends out of 52 a year, CEO says

09:30 EDT Bank of America is a 'subscription business' CEO Moynihan says

09:18 EDT Bank of America CEO: Supply chain disruption still an issue

09:18 EDT Bank of America CEO: Consumers still have more to spend - CEO Brian Moynihan is speaking at the BofA Global Research Financials CEO Conference.

09:16 EDT Veklury 'significantly' reduced hospitalization risk in high-risk Covid patients - Gilead announced positive results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury or remdesivir, for intravenous use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. This late-breaking data will be presented at the IDWeek 2021 virtual conference. In an analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 compared with placebo 5.3% p=0.008. Results also showed an 81% reduction in risk for the composite secondary endpoint of medical visits due to COVID-19 or all-cause death by Day 28 for participants treated with Veklury, 1.6% compared with placebo, 8.3% p=0.002. In the study, no deaths were observed in either arm by Day 28. Enrollment for this trial was stopped prior to fulfilling enrollment targets in April 2021, reflecting the changing epidemiology and adoption of additional treatment options at the time; however, the study continued to collect data on enrolled participants and both investigators and participants remained blinded to their assignment of Veklury or placebo. These results complement positive results from ACTT-1 and other studies in hospitalized patients in which Veklury helped patients recover significantly faster and reduced the likelihood of disease progression. "Antiviral medications provide maximal benefit when used early in the disease course. Last summer, data from clinical trials demonstrated the benefit of remdesivir in patients hospitalized with COVID-19, even when not yet requiring oxygen. These latest data show remdesivir's potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether," said Robert L. Gottlieb, MD, PhD, Cardiologist and Principal Investigator at Baylor University Medical Center and Baylor Scott & White Research Institute. "We are seeing very high numbers of hospitalized patients as new COVID-19 infections surge, placing increased demands on already over-burdened healthcare systems. Remdesivir, also known as Veklury, is an effective antiviral for the treatment of hospitalized patients with COVID-19 and an essential tool to help reduce disease progression."

09:14 EDT Berkshire Grey announces launch of AI-powered Robotic Shuttle Put Wall solution - Berkshire Grey announced the launch of its AI-powered Robotic Shuttle Put Wall (RSPW) solution for eCommerce order fulfillment. The RSPW is an automated put wall that increases capacity and throughput with robotic automation, which is more important than ever given today's heightened customer expectations for fast and efficient fulfillment and the parallel industry pressure of labor scarcity.

09:13 EDT Silicon Valley Bank doubles CareCloud's credit facility - CareCloud, Inc. (MTBC) announced that Silicon Valley Bank (SIVB), the bank of the world's most innovative companies and their investors, has increased its secured line of credit, which is currently untapped, to $20 million to support future growth. The term of the line of credit was also extended by two years, to October 13, 2023. CareCloud's revolving line of credit from Silicon Valley Bank provides up to $20 million of capital to be used for growth and general corporate purposes

09:11 EDT Gilead says Veklury reduced COVID-19 related hospital risk 87% in study

09:10 EDT Horizon Bancorp board increases quarterly dividend 15.4% to 15c per share - Horizon Bancorp announced that its Board of Directors approved a 15.4% increase in its quarterly cash dividend from 13c to 15c per share. Horizon's quarterly dividend will next be payable on October 22, 2021 to common stockholders of record as of October 8, 2021. "This will be the company's second dividend increase of 2021 and its ninth over the last 10 years, reflecting the strength and profitability of our business, and further enhancing what we believe is the compelling value proposition presented by Horizon's recent share price," Chairman and CEO Craig Dwight said. "Horizon's balance sheet, efficient operations, asset quality and commercial and consumer relationships have allowed us to continue generating meaningful retained earnings, building cash, and enhancing capital, all of which enable us to continue our uninterrupted 30-year record of paying quarterly cash dividends while maintaining a payout ratio aligned with profitability."

09:09 EDT Bombardier expands customer offerings at Dallas Service Centre - Bombardier is pleased to announce the enhancement of its interior repair and refurbishment activities at its service centre in Dallas, Texas, providing customers with even more maintenance and support capabilities. Bombardier will collaborate with Global Engineering & Technology to offer customers the industry's highest quality of enhanced interior services and support at the Dallas Service Centre. Built on a long-standing relationship between the two companies, the collaboration with Wichita-based GETI will benefit from the supplier already being well-versed with Bombardier business jets at Bombardier's service centre in Wichita, Kansas.

09:08 EDT Weyerhaeuser sets greenhouse gas emission targets - Weyerhaeuser is taking actions to contribute to climate change solutions, including: growing the company's Natural Climate Solutions business to capitalize on opportunities associated with emerging carbon markets; aligning carbon disclosures with the future Greenhouse Gas Protocol on Carbon Removals and Land Use; releasing its inaugural carbon record, disclosing that the company is significantly carbon negative and stores billions of metric tons of carbon dioxide equivalents in its U.S. timberlands; and setting a science-based greenhouse gas emissions reduction target that aligns with limiting global warming to 1.5 degrees Celsius and supports the pathway to net-zero.

09:07 EDT Outbrain, Pijper Media enter multiyear partnership agreement - Outbrain announced a new partnership agreement with Pijper Media, a media owner in The Netherlands. Via a multiyear partnership, Outbrain will be exclusively managing audience engagement and development via the company's recommendation technology across all the websites within the Pijper Media's network. Pijper Media, which includes brands such as Grazia, Marie Claire, and Beau Monde, serves more than 12 millions page views per month to their Dutch audience.

09:06 EDT GM to offer OnStar emergency service at home via Amazon partnership - General Motors (GM) and Amazon (AMZN) announced plans to introduce the OnStar Guardian skill for Amazon Alexa, a new feature that will provide a voice-enabled connection to Emergency-Certified OnStar Advisors at home through compatible Alexa-enabled devices. "The OnStar Guardian skill for Amazon Alexa is part of the OnStar Guardian platform, which aims to help keep people safe no matter where they are located. When the OnStar Guardian skill for Amazon Alexa is enabled on compatible, in-home Alexa devices, household members can reach OnStar Emergency-Certified Advisors by saying, 'Alexa, call for help,' during crisis situations, such as house fires, medical emergencies, break-ins and more," GM stated. The OnStar Guardian skill for Amazon Alexa will initially be available to select OnStar members, with the intent to broadly roll out the service, beginning in 2022, to anyone in the United States with a compatible, in-home Alexa-enabled device, such as an Echo, Echo Dot or Echo Show. Initial OnStar members will receive more details about how to sign up for the OnStar Guardian skill for Amazon Alexa via email, the company stated. Reference Link

09:06 EDT Weyerhaeuser establishes long-term strategic growth targets for 2025 - Weyerhaeuser reports its targets for driving strategic growth by year-end 2025, including: growing the company's timberlands portfolio through $1B of disciplined investments with strong returns; generating $100M of Adjusted EBITDA from Natural Climate Solutions, a fivefold increase from current levels; capturing $175M-250M of additional operational performance improvements; and growing lumber production by 5% annually to serve increasing market demand.

09:06 EDT CMS approves Clover Health's expansion plans for 2022 - Clover Health announces that the Centers for Medicare and Medicaid Services has approved the company's service area expansion to operate in 101 new counties. With this approved service area expansion beginning January 1, 2022, Clover's Medicare Advantage plans will be available to eligible individuals in 101 new counties across Georgia, New Jersey, South Carolina, Texas, and Alabama - a new state for the company. This will bring Clover's total coverage area for its Medicare Advantage plans to 209 counties across nine states. Individuals eligible for Medicare in any of the 209 counties can sign up for Clover's plans during the Annual Election Period, which runs from October 15 to December 7.

09:05 EDT Goodyear Tire to adopt 100% renewable energy at plants across Europe, Turkey - The Goodyear Tire & Rubber Company announced it will adopt 100% renewable energy at its Goodyear plants across Europe and Turkey in the first of a multiple-phase plan to procure 100% renewable energy in all its facilities across Europe, Middle East and Africa by the end of 2022. The decision, made in conjunction with the company's development of its long-term climate strategy, will enable Goodyear to reduce operational impacts and aligns with its goal of reducing carbon emissions intensity by 25% by 2023 versus a 2010 baseline. The company already achieved 19% intensity reduction in 2020 as reported in its latest Corporate Responsibility Report.

09:04 EDT First American names Lisa Cornehl VP chief legal officer - First American Financial announced that Lisa Cornehl has been named senior vice president and chief legal officer. In her new position, Cornehl will be responsible for setting the company's legal strategy and for overseeing its legal affairs. She previously served as deputy general counsel, litigation and as chief privacy officer. "Lisa is a proven legal strategist and operator who has skillfully managed our company's risk and vigorously defended its reputation," said Ken DeGiorgio, president of First American Financial Corporation. "Her keen insights into our business and strategic counsel will serve our company well as we execute on our growth strategy." Cornehl will serve as a member of First American's executive management team and report directly to DeGiorgio.

09:04 EDT BriaCell announces TSXV acceptance of Normal Course Issuer Bid - BriaCell Therapeutic announces that the TSX Venture Exchange has accepted the Company's Notice of Intention to implement a normal course issuer bid. Pursuant to the Buyback, the Company may, during the 12-month period commencing on September 28, 2021 and ending September 27, 2022 purchase, through the facilities of the TSXV or The Nasdaq Capital Market or alternative exchanges, up to 1,341,515 common shares and up to 411,962 publicly traded BCTXW warrants in total, representing 10% of the 13,415,154 Common Shares and 10% of the 4,119,622 Listed Warrants, respectively, that comprise the "public float" as of September 21, 2021. Independent Trading Group Inc. will act as the Company's advisor and dealer manager in respect of the Buyback. The Buyback will in no way interfere with BriaCell's ambitious growth plans to expand into previously-announced areas of cancer immunotherapy and/or advance its current breast cancer clinical trials.

09:03 EDT Compass to acquire First Alliance Title, terms not disclosed - Compass announced that it has signed a definitive agreement to acquire First Alliance Title, a title company serving the Denver metro area. The acquisition extends the company's growing portfolio of title and escrow businesses that now serves nine states. The transaction is expected to close before the end of the year and the terms of the deal are not being disclosed.

09:02 EDT Weyerhaeuser declares 50c interim supplemental dividend - Weyerhaeuser is declaring a one-time interim supplemental dividend of 50c per share on the common stock of the company, payable in cash on October 19 to holders of record of such common stock as of the close of business on October 5.

09:01 EDT Intrado unveils new capabilities in HouseCalls Pro - Intrado unveiled new capabilities within HouseCalls Pro, its digital patient engagement platform. HouseCalls Pro automates workflows and fosters true two-way communication between patients and health systems, creating a superior healthcare experience for patients and improving long-term outcomes.HouseCalls Pro's new automated referral management capability improves referral closure rates and care coordination for patients that require treatment by a specialist. Instead of staff calls to patients ending up in voicemail, patients are contacted via text messaging for scheduling. Based on their response, the patient can self-schedule the appointment via SMS or be connected, in real time, to the referred department.

08:55 EDT General Mills: Supply chain holding up 'as well or better than' competitors

08:54 EDT General Mills: Supply chain environment also 'dynamic,' 'challenging' - Now expects total input cost inflation in FY22 will be roughly 7% to 8%, up from prior estimate of 7%.

08:49 EDT Orion Group says company's Marine segment awarded $35M in contracts - Orion Group Holdings announced contract awards totaling approximately $35M. The Company's Marine segment has been awarded four contracts valued at a combined $35M to perform marine and infrastructure construction work in the gulf coast, as well as in Alaska. In the gulf coast, the Company has been awarded three contracts to construct marine infrastructure for private sector clients in Texas and Louisiana. Two of these awards, valued at $11.8M and $6.7M, are in the greater Houston area and call for the construction and dredging of new ship and barge berths for petrochemical loading and unloading. The third project, valued at approximately $9M, calls for the replacement of an existing barge dock at a terminal located west of New Orleans. Work on all three projects is expected to commence in the fourth quarter of 2021 and be complete by third quarter of 2022. In addition, the Company has been awarded a contract from the US Department of Transportation to demolish and replace an existing bridge in Alaska's Denali National Park. This project is valued at $7.8M and will commence late in the first quarter of 2022 with the work completed in late 2023. "We're pleased to announce these project awards, particularly those in the private sector energy and industrial spaces," said Mark Stauffer, Orion's President and Chief Executive Officer. "Our disciplined approach to bidding project opportunities is paying off, and we expect to see significant additional awards in our marine business in the coming weeks."

08:46 EDT Fulton Financial announces Anthony Cossetti joins as Chief Accounting Officer - Fulton Financial announced that Anthony L. Cossetti has joined the company as Executive Vice President, Chief Accounting Officer and Controller. Cossetti currently serves as a Finance Committee member for the National Board of Osteopathic Medical Examiners, where he was previously an Audit Committee member. He also served as an Advisory Board member to the Federal Home Loan Bank of Pittsburgh.

08:41 EDT Verizon Frontline earns Harris County, Texas ESD contract - Verizon Frontline has been awarded the contract to deliver connectivity and smartphones for the Harris County, Texas Emergency Services District, or ESD, No. 11. Verizon Frontline delivers the advanced network and technology first responders need to achieve their mission. Verizon Frontline will deliver network and smartphones for use in Harris County ESD No. 11 Emergency Medical Services trucks and ambulances.

08:39 EDT Cassava Sciences announces results of 12-month analysis of simufilam - Cassava Sciences announced clinical data from a pre-planned interim analysis of an on-going open-label study with its drug candidate simufilam in patients with mild-to-moderate Alzheimer's disease. In a study funded by the National Institutes of Health, ADAS-Cog11 scores improved an average of 3.2 points from baseline in the first 50 study subjects who completed 12 months of open-label treatment with simufilam. In the first 50 study subjects who completed 12 months of open-label treatment with simufilam: ADAS-Cog11 scores improved an average of 3.2 points from baseline; 68% of study subjects improved on ADAS-Cog at 12 months, these study subjects improved an average of 6.8 points; an additional 20% of study subjects declined less than 5 points on ADAS-Cog at 12 months, these study subjects declined an average of 2.5 points; and study subjects entered the open-label study with a clinical diagnosis of mild-to-moderate Alzheimer's, Mini-Mental State Examination range 16-26. Safety Analysis: Drug is well-tolerated. There are no drug-related serious adverse events through the 12-month interim analysis. Next Step: Phase 3 Clinical Program under FDA Special Protocol Assessments. Cassava Sciences is advancing simufilam into a Phase 3 clinical program in Alzheimer's disease. Study initiation is on-track for Q4 2021. On August 24, 2021, Cassava Sciences announced it had reached agreement with the U.S. Food and Drug Administration under a Special Protocol Assessment for both of its Phase 3 studies.

08:37 EDT Eos Energy appoints Carlos Restrepo as CTO - Eos Energy Enterprises announced that Carlos Restrepo has been named Chief Technology Officer. In this role, he will provide strategic direction over Eos' proprietary technology and its alignment with overall business goals and customer needs. Restrepo joins Eos after seven years at sonnen Inc., a global market leader in smart residential energy storage systems, where he served as Chief Technology Officer and Managing Director.

08:36 EDT Iteris awarded $1M on-call contract by City of Suffolk - Iteris announced that it has been awarded an open-ended annual services on-call contract by the City of Suffolk, Virginia's Department of Public Works for traffic signal optimization engineering services. Under the contract, which is renewable for an additional four years with an estimated potential value of up to $1M, Iteris will develop signal timing plans for signalized intersections, provide vehicle turn movement counts, perform before-and-after corridor analysis, develop hurricane evacuation timing plans and Interstate 664 diversion timing plans, and design intelligent transportation system equipment plans. The City of Suffolk encompasses 1,600 roadway miles for which Iteris' ITS experts will support traffic management operations, emergency planning and operations, and the deployment of new technologies.

08:35 EDT E-Home Household Service acquires Sijie Cleaning Service - E-Home Household Service's affiliated variable interest entity, Pingtan Comprehensive Experimental Area E Home, entered into an equity transfer agreement to acquire 51% equity interests of Fuzhou Sijie Cleaning Service in cash. Sijie Cleaning is an integrated and professional cleaning company, providing one-stop cleaning services. It is mainly engaged in providing cleaning services, environmental testing, formaldehyde treatment and indoor and outdoor wall cleaning.

08:34 EDT Acasti Pharma regains compliance with Nasdaq listing standards - Acasti Pharma provided a business update and announced that the Nasdaq Stock Market has confirmed to Acasti that the Company has regained compliance with Nasdaq's minimum bid price requirement. Jan D'Alvise, President and CEO of Acasti Pharma, commented, "We are pleased to have regained compliance with the listing requirements for Nasdaq, and are laser focused on the integration of Grace Therapeutics, which is progressing seamlessly. We could not be more excited by the outlook for the business and are working aggressively to advance our clinical pipeline of late-stage drug candidates focused on rare diseases that address significant markets with unmet medical needs. We believe our approach of customizing the formulation of marketed drugs in new ways-backed by more than 40 granted and patents pending in various jurisdictions-significantly de-risks our clinical programs. Specifically, these drug candidates are designed to achieve faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Our confidence is further reinforced by the fact that all three of our lead programs have received Orphan Drug Designation from the U.S. Food & Drug Administration, which offers a number of regulatory, cost and timing benefits. We look forward to providing continual updates on our clinical and regulatory progress in the weeks and months ahead."

08:33 EDT Franklin Wireless launches sub-6 5G mobile hotspot in conjunction with C Spire - Franklin Wireless announced that it is launching a new sub-6 5G mobile hotspot in conjunction with C Spire. All necessary certifications and approvals have been granted. Products will be available for use on C Spire's state-of-the-art 5G network beginning next month at competitive prices. Franklin's new mobile hotspot features dual connectivity, 4G LTE and the latest sub-6 5G mobile Broadband service combined with the advanced Wi-Fi6 local networking and USB tethering. Wi-Fi6 doubles the Wi-Fi bandwidth and allows multiple users to work, play, game, and enjoy 8K videos simultaneously without the delays of buffering. In addition, 2.4GHz/5Ghz dual Wi-Fi bands adds flexibility of dual connectivity and a separate guest network with added security. The new mobile hotspot is one of the smallest, lightest, and sleekest designs on the market.

08:27 EDT Comcast seeking Peacock partnerships outside the U.S., says CEO Roberts

08:22 EDT Biocept has implemented COVID-19 testing services at over 30 California colleges - Biocept announced it has implemented its COVID-19 testing services at more than 30 community college campuses across California. Since launching SARS-CoV-2 testing services for customers in June 2020, the company has received more than 570,000 samples for processing.

08:17 EDT Comcast has bought wireless spectrum in 80% of company's footprint, says CEO

08:15 EDT Comcast CEO sees 'a lot of runway' in business services

08:14 EDT Theratechnologies announces results for Trogarzo IV Push administration study - Theratechnologies announced that a study evaluating an intravenous push form of administration of Trogarzo for the treatment of human immunodeficiency virus type 1 infection achieved consistent and statistically significant results demonstrating that there was no difference in pharmacokinetics between IV Push and IV Infusion. Based on these results, a supplemental Biologics License Application is expected to be filed with the U.S. Food and Drug Administration in the fourth quarter of 2021. The TMB-302 study was conducted by the Company's partner, TaiMed Biologics, to evaluate the safety and comparability of the current Trogarzo IV Infusion mode of administration with a more convenient IV Push form of administration that can be infused within 30 seconds without dilution compared to the 15-minute infusion time of the original IV Infusion. The primary endpoint measuring a 90% confidence interval of the ratio of IV Push to IV Infusion was within the target value. The proportion of subjects with mean trough serum drug concentration equal or exceeding the target concentration was also the same for both forms of administration. Additionally, there were no serious adverse events observed and drug-related adverse events were considered mild to moderate. Secondary endpoints were also achieved confirming no difference in HIV-1 viral load due to the change from IV Infusion to IV Push. Additionally, there were no anti-Trogarzo antibodies or immunogenicity concerns of Trogarzo detected. Theratechnologies and TaiMed are currently evaluating an intramuscular method of administration for Trogarzo as part of the TMB-302 study with patient screening planned for the fourth quarter of 2021. The study will be conducted and funded by Theratechnologies with support from TaiMed. Under the terms of the agreement with TaiMed, Theratechnologies is entitled to commercialize the new IV Push and IM methods of administration of Trogarzo if, and when, approved.

08:12 EDT Comcast had 'terrific' second quarter, says CEO Roberts

08:10 EDT Certara announces new clinical science group for IDD division - Certara announced that it is expanding its Integrated Drug Development division with a new clinical science group, headed up by Philippa Marshall, M.D., Vice President of Clinical Science. The Company also appointed David Mitchell, Ph.D., as Senior Vice President of Strategic Engagement and added C. Glenn Begley M.D., Ph.D., and Colin Pillai, Ph.D., as Senior Scientific Advisors. Philippa Marshall, M.D., Vice President, Clinical Science, is a fellow of the faculty of pharmaceutical medicine at the Royal College of Physicians in the U.K. David Mitchell, Ph.D., Senior Vice President of Strategic Engagement, brings more than three decades of experience in the biopharmaceutical industry with deep expertise in clinical pharmacology and pharmacometrics. C. Glenn Begley, M.D., Ph.D., Senior Scientific Advisor, is a world-leading cancer drug development expert with more than 20 years of experience. Colin Pillai, Ph.D., Senior Scientific Advisor, has spent nearly 20 years in drug development in various leadership roles, where he has focused on applying mathematical models to decision making.

08:09 EDT CytoDyn gets Brazil clearance for study of Covid IV, four dose treatment - CytoDyn announced that Brazil's regulatory authority, ANVISA or Agencia Nacional de Vigilancia Sanitaria, has approved the start of an additional Phase 3 CD16 clinical trial of leronlimab. The new clinical trial will focus on hospitalized COVID-19 patients in critical condition who require mechanical and invasive ventilation or Extracorporeal Membrane Oxygenation, ECMO. The trial will be carried out across 22 research centers with a total of 316 patients. An interim analysis will be conducted after 40% of the patients have been enrolled and have completed a 28-day trial. The first goal for this trial is to enroll 127 patients as soon as possible. The Academic Research Organization ARO Albert Einstein Israelite Hospital in Brazil will conduct the trial in coordination with CytoDyn and BIOMM, the Company's exclusive partner for the commercialization of leronlimab in Brazil. Nader Pourhassan, Ph.D., CytoDyn's President and Chief Executive Officer, commented: "We are excited about this news and what it means for leronlimab's potential ability to successfully treat critically ill COVID-19 patients in the future all over the world. We believe the IV treatment in this trial will have an enormous advantage over treatment via subcutaneous injections, which was the route of administration in our last COVID-19 trial in the US. Furthermore, in our CD12 study, the survival benefit in the critically ill population was 78% after the first-week post the first dose of leronlimab and 82% after the second week

08:09 EDT Restaurant Brands commits to 50% greenhouse emission reduction by 2030 - Restaurant Brands will collaborate with franchisees and suppliers to pursue science-based targets for reducing greenhouse gas emissions by 50% by 2030. In addition, RBI has set a target to achieve net-zero emissions by 2050 or sooner. Achieving these targets would prevent an estimated 25.4 million metric tons of carbon dioxide equivalent emissions from being released into the atmosphere by 2030 as compared to a business-as-usual scenario.

08:07 EDT Erasca announces first patient dosed in HERKULES-3 trial evaluating ERAS-007 - Erasca announced dosing of the first patient in HERKULES-3, a Phase 1b/2 master protocol clinical trial evaluating ERAS-007 in combination with various agents in patients with gastrointestinal cancer, or GI, with initial focus on patients with advanced colorectal cancer, or CRC. "A major barrier to durable responses with current treatment regimens for GI cancers is the emergence of resistance mechanisms, which are often associated with reactivation of the MAPK pathway," said Jonathan Lim, M.D., Erasca's chairman, CEO, and co-founder. "We have developed HERKULES-3, our GI master protocol, to evaluate ERAS-007 in rational combinations to assess the possibility of reducing susceptibility to resistance and increasing durability of treatment. Initially focused on CRC subtypes with BRAF V600E, KRAS, or NRAS mutations, HERKULES-3 has the potential to address over half of patients with CRC and could be further expanded into other GI cancers with additional combinations." HERKULES-3 will examine the safety, tolerability, and preliminary efficacy of ERAS-007 in combination with other cancer therapies in study participants with GI malignancies. The dose escalation portions of the first two sub-studies will assess ERAS-007 in combination with the current standard of care, encorafenib and cetuximab, in patients with BRAF V600E-mutant mCRC, and ERAS-007 in combination with the CDK4/6 inhibitor palbociclib in patients with KRAS- or NRAS-mutant mCRC.

08:06 EDT Ceridian to participate in investor group meeting hosted by Baird - Ceridian HCM Holding announced that David Ossip, Chair and CEO, alongside Ceridian management will participate in an investor group meeting event hosted by Baird on Thursday, September 23, 2021 at 1:00 p.m. Eastern Time. The purpose of the event will be to discuss Ceridian's selection by the Government of Canada to deliver the design and experimentation phase of the Next Generation Human Resources and Pay pilot.

08:05 EDT Comcast CEO 'feels great' about company's momentum - Chairman and CEO Brian Roberts is speaking at the Goldman Sachs Communacopia Conference.

08:04 EDT Motorcar Parts unit in strategic distribution pact with TECTRA - Motorcar Parts of America announced its wholly owned subsidiary D&V Electronics, based in Woodbridge, Ontario, has established a non-exclusive strategic distribution partnership with TECTRA a.s. to leverage this Prague-based organization's position in the European testing solutions market. "The partnership enhances our presence within the Czech Republic and leverages D&V's reputation for leading-edge testing and diagnostic equipment utilized in the development and production of electric vehicles," said Selwyn Joffe, chairman, president, and chief executive officer.

08:04 EDT Kaltura selects Oracle Cloud Infrastructure to accelerate its global expansion - Oracle (ORCL) announced that Kaltura (KLTR) selected Oracle Cloud Infrastructure to support its growth and accelerate its global expansion. To meet fast-growing demand in the enterprise video market, Kaltura will deliver its Video Experience Cloud on OCI to power real-time, live, and on-demand video experiences to customers around the world. In addition, Kaltura and Oracle are extending their strategic OEM partnership to make the full range of Kaltura video capabilities and experiences such as video content management, live streaming, real-time conferencing, interactive video paths, and visual marketing available across Oracle Cloud.

08:02 EDT Atlas Air announces new ACMI contract with FedEx - Atlas Air Worldwide (AAWW) announced its subsidiary Atlas Air has entered into a long-term agreement with FedEx (FDX) to provide two 747-400 freighter aircraft on a full-time aircraft, crew, maintenance and insurance, or ACMI, basis. This new agreement is in addition to the company's existing multi-year peak season contract that provides FedEx with a minimum of five aircraft during the fourth quarter. Both 747-400 freighters have entered service and are flying on behalf of FedEx to support their growing express and e-commerce network. "We are pleased to grow our long-term relationship with FedEx. This agreement reflects the continued strong demand for airfreight capacity, particularly in the express and e-commerce markets," said John Dietrich, President and Chief Executive Officer of Atlas Air Worldwide. "Atlas is a leader in supporting express networks, with a focus on operating the most modern, fuel-efficient aircraft to deliver high levels of on-time performance for our customers."

08:01 EDT Inovio receives Mexican authorization to conduct Phase 3 trial of INO-4800 - Inovio announced that it has received authorization from COFEPRIS, the national health regulatory agency of Mexico, to conduct a clinical trial in that country as part of the Phase 3 segment of INOVIO's global Phase 2/3 trial, INNOVATE, for its DNA vaccine candidate for COVID-19, INO-4800. INOVIO is working with its partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. on the INNOVATE Phase 3 segment in multiple countries. INOVIO recently announced that it has received regulatory authorization to proceed with Phase 3 clinical trials in Brazil and the Philippines and is seeking authorization to conduct trials in additional countries.

07:44 EDT Biogen falls after STAT says just over 100 patients on Aduhelm as of Sept. 11

07:42 EDT Cathie Wood's ARK Investment bought 189K shares of Teladoc on Tuesday

07:40 EDT Cathie Wood's ARK Investment bought 84K shares of Roku on Tuesday

07:38 EDT Dicerna appoints Rob Ciappenelli as Chief Strategy Officer - Dicerna Pharmaceuticals announced the appointment of Rob Ciappenelli as Chief Strategy Officer, the promotion of Marc Abrams, Ph.D., to Senior Vice President, Discovery Research and the addition of Kristen Sheppard to Dicerna's executive leadership team as Senior Vice President, Investor Relations and Corporate Communications. "As we advance our innovative pipeline and position Dicerna for the next phase of growth, we believe these new executive appointments reinforce our strong focus on operational execution across our organization and the effective communication of Dicerna's performance and strategy to all our stakeholders," said Douglas Fambrough, Ph.D., President and Chief Executive Officer at Dicerna. "I am excited to welcome Kristen to our executive management team and look forward to Rob's and Marc's additional leadership in furthering Dicerna's mission as a biopharmaceutical leader in RNAi innovation."

07:37 EDT Salarius Pharmaceuticals, Fox Chase Cancer Center launch partnership - Salarius Pharmaceuticals announced a research partnership with the Cancer Epigenetics Institute at Fox Chase Cancer Center. The research, to be carried out by the laboratory of Johnathan Whetstine, PhD, the institute's director, will help identify new indications and potential biomarkers for Salarius' lead drug candidate, seclidemstat. Seclidemstat is a novel, oral, reversible inhibitor of lysine-specific histone demethylase 1, also referred to as LSD1, an enzyme that plays a key role in the development and progression of several cancers. Therapies designed to inhibit LSD1's cancer-promoting activity represent a growing field of research. Salarius believes seclidemstat uses a unique approach compared to other LSD1 inhibitors now in development by simultaneously targeting the enzymatic activity of LSD1 and its scaffolding properties, creating a dual mechanism of action that could provide differential therapeutic activity in several cancer types, including solid tumors. To date, the therapeutic activity of LSD1 inhibitors in clinical development has largely been confined to hematological cancers and myeloproliferative neoplasms. A Phase 1/2 clinical trial is now underway exploring seclidemstat as a therapy for sarcomas. This trial is treating patients with myxoid liposarcoma and other FET-rearranged sarcomas with single-agent seclidemstat and evaluating seclidemstat in combination with the chemotherapy agents topotecan and cyclophosphamide as a potential second- and third-line therapy for Ewing sarcoma, a deadly pediatric bone cancer. Recently, Salarius' clinical program for seclidemstat expanded into hematologic cancers, with the MD Anderson Cancer Center in Houston initiating a Phase 1/2 clinical trial studying seclidemstat in combination with azacytidine in myelodysplastic syndromes and chronic myelomonocytic leukemia. "This is an exciting opportunity to advance our development of seclidemstat by harnessing the scientific expertise of a renowned cancer research center and one of the rising stars in the field of LSD1 inhibition," stated David Arthur, Chief Executive Officer of Salarius Pharmaceuticals. "To have Fox Chase and a scientist of Dr. Johnathan Whetstine's caliber involved in this project is a strong validation of our work with seclidemstat. With the help of Fox Chase Cancer Center and Dr. Whetstine, our ultimate aim is to bring new treatment options and hope to more patients and their families fighting hard-to-treat cancers."

07:35 EDT Frequency Therapeutics reports data from FX-322-111 open-label study - Frequency Therapeutic announced that four additional sensorineural hearing loss, SNHL, subjects from its FX-322-111 open-label study achieved statistically significant hearing improvements when evaluated 8 to 12 months following initial dosing. Including the five initial responders, there are now a total of nine subjects that participated in the FX-322-111 study that have been shown to have statistically significant improvements in word recognition scores, a key measure of speech perception, at time points between 90 days and one year. These new results suggest that the hearing of individuals administered with a single dose of FX-322 may improve over extended periods. The longer-term measures of their treated ear demonstrated word recognition score improvements when compared to pre-treatment baseline levels and no significant changes were detected in their untreated ears. Of the five subjects that had a statistically significant response at day-90, the four that returned for evaluation had scores that remained above their baseline word recognition measures, though were below the threshold for statistical significance. FX-322 is Frequency's lead product candidate for the treatment of acquired SNHL, which is the primary cause of more than 90 percent of all cases of hearing loss. FX-322 is designed to regenerate auditory sensory hair cells located in the cochlea within the inner ear and to potentially restore hearing in individuals with SNHL...An overview of the FX-322-111 study will be shared in a late-breaking scientific presentation titled, A Second Independent Phase 1b Demonstrates Hearing Improvement with FX-322, at the American Academy of Otolaryngology - Head and Neck Surgery Annual Meeting and OTO experience, on October 4 .

07:34 EDT Revival Gold completes initial stage of 2021 heap leach test work program - Revival Gold announces completion of the initial stage of the Company's 2021 heap leach metallurgical test work program for the Beartrack-Arnett Gold Project located in Idaho, USA. The work is being performed by SGS Lakefield under the direction of metallurgical staff from Revival Gold's engineering consultant, Wood. Sample material, consisting of 1.94 tonnes of material from Beartrack and 0.80 tonnes of material from Arnett, was delivered to SGS in June 2021. The first stage of the test work program included head analysis, acid base accounting and bottle roll tests. The second stage of the program consists of column tests and will commence this month. The primary goal of the test work program is to optimize Beartrack-Arnett heap leach recoveries and build on previous test work used in Revival Gold's 2020 phase one heap leach Preliminary Economic Assessment. Results will be used to establish recovery parameters for a heap leach Pre-Feasibility Study, which is scheduled to be completed by Wood in the second half of 2022. Bottle roll tests were undertaken at three crush sizes, with nine tests per size, for a total of 27 tests. The effect of crush size on overall gold recovery was evaluated. Test results are summarized below in Tables 1 and 2 with gold grades and recoveries reported on a fire assay basis. While these results do not represent the ultimate gold extraction levels to be used in the PFS, they are generally consistent with, or more favourable than, recovery assumptions used in the PEA. The second stage of Revival Gold's metallurgical test work program will consist of twelve standard column tests including tests on Beartrack oxide, transition and sulphide mineralization, and Arnett oxide gold mineralization. The tests will also include the evaluation of a mixed sample consisting of 50% Beartrack oxide and 50% Beartrack sulphide material. Column tests will be undertaken over 120-day, 180-day, 240-day and 360-day periods. The total program will require one year to complete. The longer test periods are intended to capture the effect of blending transition and sulfide mineralization into the leach pads with respect to metallurgical and environmental behaviour. Based on the results from the bottle roll tests reported above, columns were set to a P80 crush size of 38 mm. This size is consistent with the standard crushing system adopted in the PEA and will allow for optimal leach kinetics. The PEA featured Beartrack-Arnett mineralization amenable to gold recovery using standard cyanide heap leach processing. This first phase project encompasses less than one third of the available mineralized material in the overall project resource. The estimated average recovery of gold from the heap leach pad in the PEA was estimated to be 60% reflecting average recoveries of 87% for oxide material, 55% for transition material and 28% for sulfide material. Historical heap leach recoveries at the Beartrack Mine averaged approximately 70% of contained gold. Historical test-work on Arnett material indicated that the material tested is highly amenable to gold recovery by cyanide leaching. Tests were leached for 48 hours and resulted in gold extractions of 85-95%.

07:33 EDT Axon receives Taser order from Puebla Municipal Police, Mexico - Axon announced that Puebla Municipal Police Department will equip officers with Taser conducted electrical devices. Puebla Police joins Monterrey Police Department in Taser device expansion in Mexico.

07:11 EDT View Inc. Smart Windows installed at NTT's newly opened hub - View announced its smart windows have been installed at NTT's new innovation headquarters, the NTT OneVision Center, in Sunnyvale, CA, which formally opened this week. View Smart Windows use artificial intelligence to automatically adjust in response to outdoor conditions, increasing access to natural light and views of the outside while controlling temperature and glare. View Smart Windows have been shown to reduce building energy consumption from lighting and HVAC by up to 20%, helping the LEED Platinum building achieve a NetZero rating. In addition, by eliminating glare, View Smart Windows also increase the amount of usable floor space. "View is on a mission to transform buildings into smart, connected environments that improve human health and address climate change," adds Dr. Rao Mulpuri, Chairman and CEO of View. "NTT is a global leader in the Internet of Things and we are thrilled to help them showcase how smart buildings can improve employee wellbeing and enhance environmental sustainability."

07:10 EDT Millicom announces early participation results for exchange offer - In connection with its previously-announced offer to exchange its outstanding 6.625% Senior Notes due 2026 for 4.500% Senior Notes due 2031, Millicom International Cellular announces the results as of the Early Participation Date and increases the Maximum Acceptance Amount for the Exchange Offer to accept all 2026 Existing Notes that were validly tendered and not validly withdrawn by the Early Participation Date. The Early Participation Date with respect to the Exchange Offer occurred at 5:00 PM, New York City time, on September 21, 2021. According to information provided by D.F. King, the information and exchange agent for the Exchange Offer, US$335,716,000 aggregate original principal amount of the Old Notes, were validly tendered and were not validly withdrawn prior to or at the Early Participation Date, resulting in the oversubscription of the Exchange Offer. As discussed in the offering memorandum related to the Exchange Offer, dated September 8, 2021, in February 2021, the Company redeemed 10%, or US$50 million, of the then-outstanding aggregate principal amount of the Old Notes, which amount was recorded by Euroclear, Clearstream and DTC as a prepayment of principal. In accordance with the procedures of Euroclear, Clearstream and DTC, book-entry positions of the Old Notes reflect the aggregate original issued principal amount and a pool factor of 90%. The Old Notes trade with the Pool Factor, which means the percentage of the US$500,000,000 aggregate original principal amount of the Old Notes that remains outstanding after the impact of the Company's optional redemption of US$50 million in Old Notes in February 2021, which equals 90%. References to the "original" principal amount of the Old Notes refer to the US$500 million aggregate original principal amount of the Old Notes issued in October 2018, or portions thereof, without giving effect to the Partial Redemption or the Pool Factor. Holders of the Old Notes validly tendered and not validly withdrawn by the Early Participation Date are eligible to receive $1,018.12 in principal amount of New Notes per US$1,000 in outstanding principal amount on the Old Notes validly tendered and accepted for exchange pursuant to the terms of the Offering Memorandum. The principal amount of New Notes to be issued in exchange for each US$1,000 outstanding principal amount of the Old Notes was calculated by dividing $1,053.75 of which US$31.05 constitutes an early participation payment, by $1,035.00. Concurrently with the Early Participation Date, the Withdrawal Date has also occurred. As a result, any Old Notes validly tendered on or after the date of the Early Participation Date may not be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law.

07:08 EDT Arcturus Therapeutics receives Vietnam approval to continue ARCT-154 enrollment - Arcturus Therapeutics announced that it has completed dosing of 100 subjects for the Phase 1 portion of the ARCT-154 Phase 1/2/3 clinical trial, which consisted of a two-dose regimen with injections 28 days apart. The Vietnam Ministry of Health has reviewed the safety data following both injections in the Phase 1 part of the study and has given permission to proceed with enrollment of Phase 2 and Phase 3a. Recruitment of these cohorts is now progressing. Emergency Use Authorization filing in Vietnam could be as soon as December. The tolerability profile of ARCT-154 in the Phase 1 study was favorable. The Phase 2 and Phase 3a studies will evaluate safety and immunogenicity in an additional 900 subjects in total, and the subsequent Phase 3b will evaluate safety and efficacy in approximately 20,000 subjects.

07:05 EDT Oxford Biomedica announce strategic investment by Serum Life Sciences - Oxford Biomedica announces that Serum Life Sciences has agreed to invest just over GBP50M in the Group in return for new ordinary shares representing 3.9% of the outstanding shares after the capital increase. The subscription price per new ordinary share to be paid by SLS is equal to the closing middle market price on Tuesday, 21 September 2021. The proceeds of the Transaction will be used to fund the development of the fallow area at Oxbox, the Group's 84,000 sq. ft manufacturing facility based in Oxford, UK, into a flexible advanced manufacturing space and the validation of several independent cGMP suites, expected to come online in mid-2023. Oxbox was constructed by the Group during 2019 and the first phase of development, totalling 45,000 sq. ft., consisted of four GMP manufacturing suites, two fill and finish suites and supporting areas such as warehouse, cold chain facilities and QC laboratories. Three suites are currently dedicated to producing COVID-19 vaccine at 1000L scale and one suite is producing lentiviral vector-based products for the Group's other partners. The remaining 39,000 sq. ft. will be developed using the proceeds of the Transaction to allow for flexible expansion and use. This is expected to include manufacturing capacity for viral vector-based products, including vaccines. The investment from SLS, a company which was set up to market coronavirus disease vaccines manufactured by Serum Institute of India, will allow Oxford Biomedica to continue to expand the capacity of the Group's world class facilities in anticipation of growing demand for the Group's world leading capabilities. Under the Subscription Agreement entered into by SLS and Oxford Biomedica in relation to the Transaction, SLS has agreed to subscribe for 3,382,950 new ordinary shares of 50 pence each in Oxford Biomedica at a price of GBP14.78 per share, amounting to an investment of GBP50,000,001. The Subscription Shares are to be issued on a non pre-emptive basis utilising the authority granted at the Group's 2021 AGM which allows Oxford Biomedica to issue ordinary shares free of pre-emption rights for the purposes of an acquisition or specified capital investment. Applications will be made for the Subscription Shares to be admitted to the premium listing segment of the Official List of the Financial Conduct Authority and to be admitted to trading on the main market for listed securities of the London Stock Exchange. Admission of the Subscription Shares and completion of the Transaction is expected to take place at 8.00 a.m. on 27 September 2021.

07:05 EDT Verastem appoints Louis Denis M.D Chief Medical Officer - Verastem Oncology announced the appointment of Louis J. Denis, M.D., as Chief Medical Officer. Dr. Denis brings more than 25 years of clinical development and oncology expertise to Verastem. "Louis' proven track record in drug development, including targeting the RAS pathway for treatment of cancer, and his background as a medical oncologist will be invaluable as we advance our registration-directed trials of VS-6766 and defactinib through the clinic," said Brian Stuglik, CEO of Verastem Oncology.

07:03 EDT Taysha Gene Therapies receives orphan drug designation for TSHA-102 from EC - Taysha Gene Therapies announced that it has been granted orphan drug designation from the European Commission for TSHA-102, an AAV9-based gene replacement therapy in development for Rett syndrome.

06:58 EDT Carrier Global to acquire Nlyte Software, terms undisclosed - Carrier Global announced that it has signed an agreement to acquire Nlyte Software. Nlyte helps customers manage their IT infrastructure and drives digital transformation of data centers. Its DCIM software provides centralized management of all data center resources. Nlyte will become part of Automated Logic, Carrier's building automation and controls business, within Carrier's HVAC segment. Carrier expects to close its acquisition of Nlyte in Q4 subject to customary closing conditions. The terms of the transaction were not disclosed.

06:57 EDT Aecom to develop hydrogen-powered railway in central Italy - Aecom announced it has signed a memorandum of understanding with Spanish renewables group Iberdrola, and Italian partners Cinque International and Ancitel Energy and Environment, to upgrade Italy's historic Apennine diesel railway with hydrogen trains. This project aims to aid economic growth for the Apennine region. Aecom and its partners are working on four projects to support sustainable economic recovery in the region, which was badly affected by earthquakes in 2009 and 2016 and has suffered from decades of depopulation. Under the MOU, Aecom is leading engineering and program management, with Iberdrola acting as industrial partner.

06:50 EDT NanoViricides reports improved safety profile of remdesivir - NanoViricides reported on the advantages gained by remdesivir encapsulation within its lead COVID-19 candidate NV-CoV-2 thereby resulting in the dual-acting drug candidate NV-CoV-2-R with the promise of a potential pan-coronavirus cure. Almost double the amount of remdesivir remained intact in plasma when given as the encapsulated NV-CoV-2-R form, in comparison to the standard remdesivir formulation made in betadex sulfobutyl ether sodium, during the first day of dosing in a rat pharmacokinetics study. Additionally, remdesivir accumulation was observed on repeated dosing of NV-CoV-2-R. After the fifth dose of NV-CoV-2-R, in comparison to the standard remdesivir dosing pattern, the circulating level of intact remdesivir in plasma was 75% greater in the NV-Cov-2-R group as compared to the standard remdesivir group. The data were normalized to reflect the same amount of remdesivir given to the animals per kg body weight for uniform comparison. The assays were performed using the well-established isotopic internal standard method of remdesivir estimation with LCMS detection. The increased circulating level of intact remdesivir when given as NV-CoV-2-R encapsulated formulation without any increase in toxicity is significant. It can be expected to result in improved antiviral effectiveness of the remdesivir component in human usage of NV-CoV-2-R treatment. This is important because remdesivir is a highly effective drug in cell culture and pre-clinical studies but does not show clinical effectiveness in humans at levels that would be expected based on its cell culture efficacy because of its rapid metabolism. Additionally, there is very little margin to increase remdesivir dosing in its standard formulation because of dose limiting toxicity. NV-CoV-2-R was found to be less toxic than the standard remdesivir formulation in this study. At day 7, when a total of 80mg/kg remdesivir was dosed in the standard formulation, the body weight loss was approximately 9.5% in male and 9.5% in female animals. In contrast, when 80mg/kg of remdesivir was delivered as NV-CoV-2-R encapsulated formulation, at day 7, the weight loss was only approximately 3% in male animals and 1% in female animals which was the same as with the vehicle treatment reflecting injection trauma itself and no drug toxicity. These data demonstrate that the pan-coronavirus nanoviricide drug candidate NV-CoV-2-R decreases the loss of remdesivir to bodily metabolism in comparison to the standard formulation. The company anticipates that this stabilizing effect should lead to a highly effective pan-coronavirus drug that could potentially cure most cases of COVID-19 infection. Both remdesivir and NV-CoV-2 have demonstrated broad-spectrum activity against coronaviruses. Thus NV-CoV-2-R is expected to continue to be active in spite of evolution of novel variants of SARS-CoV-2. In contrast, antibody drugs and vaccines which induce antibodies lose effectiveness against variants. The more the variant drifts from the original strain, the less protection is offered by vaccines, and effectiveness of antibodies also diminishes significantly. This is now known to be occurring for current vaccines and antibodies during the global COVID-19 pandemic. NV-CoV-2-R combines the nanoviricides platform attacking the virus particle outside cells with remdesivir in attacking the virus reproduction inside cells. Additionally, the company believes that NV-CoV-2-R would be improving the effect of remdesivir by enabling a higher effective concentration of remdesivir in the body and sustaining this higher concentration for a substantially longer period of time, both compared to the standard formulation of remdesivir, as observed in this pharmacokinetic animal study. NV-CoV-2-R combines two different mechanisms of attack against the virus and therefore is expected to be substantially more difficult for the virus to evade than either NV-CoV-2 or remdesivir alone. This is important because scientists believe it is only a matter of time before variants of SARS-CoV-2 that evade current vaccines and antibody drugs become commonplace. Both NV-CoV-2 and remdesivir are expected to retain their effectiveness against variants of SARS-CoV-2. NV-CoV-2 has shown effectiveness against multiple unrelated coronavirus types. Remdesivir has been demonstrated to possess antiviral activity in cell culture against a large number of RNA viruses. The standard Veklury formulation of remdesivir in betadex sulfobutyl ether sodium helps with suspending remdesivir in solution, but does not appear to significantly improve upon the metabolic effects. In contrast, NV-CoV-2-R is an encapsulation approach wherein remdesivir would slowly leak out into the bloodstream from the polymeric nano-micelle over time, imparting protection against metabolism and sustained effective levels of the encapsulated drug component over a longer time period.

06:37 EDT Immunic enters in-license deal with UMC Goettingen for DHODH inhibitors combo - Immunic announced the execution of an in-license agreement with the University Medical Center Goettingen, Germany, covering the combination of DHODH inhibitors and nucleoside analogues to treat viral infections such as COVID-19 and Influenza. Terms of the agreement were not disclosed.

06:10 EDT Allot Ltd.'s NetworkSecure solution selected by Italian broadband provider - Allot Ltd. announced that Italian broadband provider Eolo has decided to expand their Allot NetworkSecure capacity to meet the demand of a growing number of their fixed wireless consumer customers who are requesting cybersecurity services. To enable the growth in requests, Eolo has ordered an expansion of its software license from Allot. NetworkSecure is a network-based cybersecurity service platform, requiring no application installation by the end customer. With NetworkSecure, the service provider can offer its customers protection from cybersecurity threats, including malware, viruses, phishing and ransomware.

06:04 EDT Corvus Pharmaceuticals provides update on mupadolimab in viruses and tumors - Corvus Pharmaceuticals provided an update on its development programs in oncology and infectious disease for mupadolimab. Corvus is developing mupadolimab as a therapeutic for oncology indications and for infectious disease, starting with COVID-19. Results from its Phase 3 clinical trial of mupadolimab for COVID-19, which cover 40 patients enrolled in the trial prior to its voluntary discontinuation, suggest improvement in the primary and key secondary endpoints in patients treated with single doses of mupadolimab at 2mg/kg and 1mg/kg compared to placebo. No drug related adverse events were reported in the trial. The company believe there is mounting evidence that mupadolimab could become a universal treatment for viral diseases, with the ability to address immune escape from variants. The company plans to evaluate next steps with mupadolimab for COVID-19 as it explores partnership opportunities to continue its development as a therapeutic. Mupadolimab also is currently being studied in a Phase 1b/2 clinical study in patients with HPV+ oropharyngeal cancers and non small cell lung cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy. Data from the Phase 1b/2 clinical study has been accepted for presentation at the Society for Immunotherapy of Cancer annual meeting in November.

05:51 EDT Netflix confirms acquisition of Roald Dahl Story Company - Ted Sarandos, Co-CEO and Chief Content Officer at Netflix, and Luke Kelly, Managing Director, RDSC and Roald Dahl's grandson, said in a blog post that Netflix (NFLX) and the Roald Dahl Story Company are "joining forces to bring some of the world's most loved stories to current and future fans in creative new ways." "This acquisition builds on the partnership we started three years ago to create a slate of animated TV series. For example, Academy Award winning filmmaker Taika Waititi and Academy Award nominee Phil Johnston are now hard at work on a series based on the world of Charlie and the Chocolate Factory. In addition, we're working with Sony (SONY) and Working Title on an adaptation of Matilda The Musical. These projects opened our eyes to a much more ambitious venture - the creation of a unique universe across animated and live action films and TV, publishing, games, immersive experiences, live theatre, consumer products and more... These stories and their messages of the power and possibility of young people have never felt more pertinent." Reference Link

05:32 EDT Aerojet Rocketdyne selected by NASA to build OME for Orion spacecraft - NASA has selected Aerojet Rocketdyne to build the Orion Main Engine, or OME, the primary propulsion element for NASA's Orion spacecraft that will be used to explore deep space. Under the contract, which runs through 2032, Aerojet Rocketdyne will deliver up to 20 new OME engines for use on future Artemis missions beginning with Artemis VII, or to support other NASA-sponsored, deep space exploration missions. The OME is a 6,000 pound-thrust bipropellant engine that is mounted on Orion's European Service module and will be built at Aerojet Rocketdyne's Los Angeles, California, and Redmond, Washington, facilities. The engine is used for major maneuvers in space, such as entering and departing lunar orbit, and in some mission abort scenarios. The first six Orion missions will use refurbished Orbital Maneuvering System engines that were provided by Aerojet Rocketdyne for the space shuttle program.

05:29 EDT Liberty Global to sell Poland operations to iliad subsidiary for $1.8B - Liberty Global announced it has reached a definitive agreement to sell 100% of its operations in Poland to iliad S.A.'s Polish mobile subsidiary Play. At June 30, networks in Poland passed 3.7M homes and served 1.5M customers who subscribed to 1.3M broadband, 1.4M video, and over 600,000 telephony services. Liberty Global has agreed to sell UPC Poland for a total enterprise value of $1.8B subject to customary debt and working capital adjustments at completion. The sale price represents a multiple of approximately 9x UPC Poland's estimated 2021 adjusted EBITDA, and nearly 20x its estimated 2021 operating free cash flow. Closing of the transaction is subject to satisfaction of customary closing conditions, including receipt of requisite regulatory approvals. The closing is currently expected to occur in the first half of 2022. Iliad S.A. is the parent company of the iliad Group, which operates under the trade names of Free in France, iliad in Italy and Play in Poland. Play is a consumer-focused mobile network operator in Poland with over 15 million subscribers. It provides mobile voice, messaging, data and video services for both consumers and businesses on a contract and prepaid basis under the umbrella brand Play. Its modern and cost-efficient 4G LTE/5G telecommunications network covers 99% of the Polish population. Proceeds from the sale are expected to be used for general corporate purposes, which may include reinvestment into our business and support for the company's significant, multi-year share buyback commitment. In conjunction with the transaction, Liberty Global has agreed to provide Play with certain transitional services for a period of up to four years. These services principally will be comprised of network and information technology-related functions. Annual charges will depend upon the actual level of services required by Play.

05:19 EDT Integer to construct new medical device, manufacturing facility in Ireland - Integer announced it will further expand its presence in Galway, Ireland, with the construction of a new medical device innovation and manufacturing facility in the Parkmore East area of Galway. This new facility is required to meet increased demand for regional research, development and manufacturing capabilities as well as capacity for catheters and delivery systems. It adds to Integer's 15 global manufacturing sites and current presence in Ireland, which includes an R&D center in Galway and manufacturing facilities in Galway and New Ross, County Wexford. The initial phase of the project will include construction of a 60,000 square foot facility on land purchased from IDA Ireland and involves a projected $30M investment over the next several years. Construction is anticipated to kick off in 2022, with an estimated completion in late 2023. Once complete, all new regional research, development and manufacturing will be housed in this facility, with equipment investments continuing over the following two to three. This initial phase will satisfy Integer's immediate space requirements in the region; however, the company has obtained planning permission for a total of 147,000 square feet for future expansion when needed. The company currently employs approximately 1,300 people in Ireland, with 350 located in Galway. The addition of the new Galway facility is projected to add an estimated 100-200 engineering, administration and manufacturing jobs to Integer over the next several years, while the design and construction activities are expected to employ several hundred third-party contractors in the Galway region.

05:11 EDT Lear, Hu Lane Associate enter joint venture in Yangzhou - Lear announced it has signed a definitive agreement for a joint venture with Hu Lane Associate, a manufacturer of automotive connector products. Assuming expected regulatory approvals are obtained, the joint venture will be based initially in Yangzhou, China. It will immediately expand Lear's vertical integration capabilities to engineer and produce a portfolio of connection systems products for current and future vehicle architectures offered by global automotive manufacturers. Founded in 1977, Hu Lane has multiple sales offices throughout southeast Asia. It operates manufacturing operations in Nanjing and Dongguan, China, and in Hanoi, Vietnam. Lear and Hu Lane anticipate regulatory approval and the joint venture management to be appointed during the fourth quarter. Lear will own a majority equity interest in the joint venture and will consolidate its financial results.