Stockwinners Market Radar for September 30, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:53 EDT Alcoa to enter deal with FYI Resources to produce high-purity alumina - Alcoa intends to enter the growing high-purity alumina market to address increasing demand for sustainable products through a joint development project. Alcoa of Australia, a subsidiary of Alcoa Corp, has executed a binding term sheet with Western Australia-based FYI Resources Ltd for development activities to produce high-purity alumina, or HPA. Alcoa of Australia will hold a 65% ownership interest in the project, which will have stages of development before potential construction, in 2024, of a full-scale, 8,000 metric-ton-per-year HPA plant.

18:55 EDT Zoom Video confirms termination of merger agreement with Five9 - Zoom Video Communications (ZM) announced that Zoom and Five9 (FIVN) have mutually terminated the merger agreement executed by the parties on July 16. At Five9's special meeting of stockholders held on September 30, Five9 did not obtain the requisite stockholder support for the merger agreement. As a result, Zoom and Five9 each had the ability to terminate the merger agreement. "While we were excited about the benefits this transaction would bring to both Zoom and Five9 stakeholders, including the long-term potential for both sets of shareholders, financial discipline is foundational to our strategy," said Eric Yuan, CEO and Founder of Zoom. "The contact center market remains a strategic priority for Zoom, and we are confident in our ability to capture its growth potential. At Zoomtopia, we announced the Zoom Video Engagement Center, our cloud-based contact center solution, which will launch in early 2022. Video Engagement Center will be a flexible, easy-to-use solution that connects businesses and their customers. We are building this new solution with the same scalability and trusted architecture that has made Zoom the platform of choice for businesses around the world. We also plan to maintain our valued existing contact center partnerships with companies like Five9, Genesys, NICE inContact, Talkdesk, and Twilio. We remain focused on driving long-term value creation for Zoom shareholders and delivering happiness to our customers through our broad-based communications platform including unified communications, developer, and events solutions."

18:34 EDT Five9 CEO says positioned to grow market share - CEO Rowan Trollope states: "Five9 has built an industry-leading and differentiated cloud contact center platform that has transformed the way businesses engage with their customers. Over the past few months, we have continued to execute relentlessly in the market. With a focus on product innovation, excellence in go-to-market execution and a strong and evolving partner ecosystem, we continue to strengthen our relationships with customers and bring new businesses onto the Five9 platform. We also hosted our largest ever annual CX Summit and, this week, were recognized by expert industry analysts as having the best application of Artificial Intelligence. The contact center is the new front door for business and, as the market shifts from on-premises to cloud and digital transformation accelerates, we believe we are positioned to build on this momentum and grow market share. We had the opportunity to engage extensively with our shareholders since our transaction announcement. We greatly appreciate their feedback and confidence in Five9's future prospects and share their views regarding the significant potential for value creation as a standalone company. We look forward to sharing additional information on our plans to deliver continued industry outperformance and profitable growth in connection with our third quarter financial results on November 8 and Financial Analyst Day on November 18."

18:14 EDT Lordstown Motors jumps 11% after Hon Hai Precision partnership on EV production - In after-hours trading, shares of Lordstown Motors are up 11% to $8.84.

18:06 EDT Lordstown Motors provides production, financial update - Lordstown Motors (RIDE) announced that the company and Hon Hai Technology Group (HNHPF) have reached an agreement in principle to work jointly on electric vehicle programs in the company's assembly plant in Lordstown, Ohio. In connection with this announcement, the company is updating its production plan and financial outlook. The Lordstown Motors team continues to move forward with its plan to build a limited number of vehicles for testing, validation, verification and regulatory approvals during the balance of 2021 and the first part of 2022. In light of the Foxconn agreement, the company will evaluate the potential impact of the parties' contract manufacturing relationship on commercial production, supply chain opportunities with Foxconn and the appropriate integration and timing of the parties' operations teams and will provide an update on its production plan during its upcoming Q3 2021 earnings call currently slated for mid-November. The company is updating its 2021 financial outlook last provided during its Q2 earnings call, as follows: Capital expenditures - unchanged in total from $375M-$400M, including changes in timing of tooling and equipment purchases and the inclusion of forecasted soft tooling expense purchases previously included in R&D expense. SG&A expenditures - $105M-$120M, up from $95M-$105M, primarily due to higher legal and professional fees. R&D expenditures - $320M-$340M, up from $310M-$320M, largely due to increased prototyping and pre-production expenses, reduced by the impact of moving forecasted soft tooling expense to capital expenditures as mentioned above. Cash balance on September 30, 2021 - $210M$240M, down from $225M-$275M, which includes approximately $20M of proceeds from the issuance of common stock under the company's Equity Purchase Agreement in August and September but excludes proceeds from Foxconn's purchase of $50M of the company's common stock as announced on September 30.

18:01 EDT Stamps.com stockholders approve merger with Thoma Bravo - Stamps.com announced that at a special meeting of stockholders held on September 30, 2021, the stockholders of the company voted to approve a proposal to adopt the merger agreement entered into between the Company and Thoma Bravo, a leading software investment firm. Under the terms of the merger agreement announced on July 9, 2021, Stamps.com stockholders will receive $330.00 per share in cash for each share of Stamps.com common stock they own.

17:37 EDT Union Pacific appoints Sheri Edison to Board of Directors - Union Pacific (UNP) announced Sheri Edison has been elected to the company's board of directors, effective December 1. Edison most recently served as executive vice president and general counsel for Amcor (AMCR).

17:33 EDT GlaxoSmithKline awarded $279.86M Army contract - GlaxoSmithKline was awarded a $279.86M firm-fixed-price contract for procurement, storage, and distribution of GlaxoSmithKline's monoclonal antibody therapeutic treatment Sotrovimab. Bids were solicited via the internet with one received. Work will be performed in Durham, North Carolina, with an estimated completion date of May 19, 2022. FY21 Defense Production Act purchases, defense funds in the amount of $279.86M were obligated at the time of the award. U.S. Army Contracting Command is the contracting activity.

17:29 EDT Boeing awarded $391.36M Army contract - Boeing was awarded a $391.36M fixed-price incentive contract for up to five CH-47F renew aircraft. Bids were solicited via the internet with one received. Work locations and funding will be determined with each order, with an estimated completion date of September 30, 2025. U.S. Army Contracting Command is the contracting activity.

17:24 EDT Churchill Downs provides update on Louisiana operations reopenings - Churchill Downs announced that Fair Grounds Race Course & Slots and 12 of the company's 15 Off-Track Betting facilities in Louisiana that were impacted by Hurricane Ida have reopened. Fair Grounds and eight of the OTB's were reopened by September 15 and four of the OTB's were reopened between September 20 and September 26. CDI continues to actively develop and execute plans to reopen the three properties that are closed. CDI has property insurance including business interruption coverage subject to applicable deductibles.

17:21 EDT Fluor awarded $1.16B Navy contract modification - Fluor was awarded a $1.16B cost-plus-fixed-fee modification to a previously awarded contract to exercise the FY22 option for naval nuclear propulsion work at the Naval Nuclear Laboratory. FY21 operation and maintenance funds in the amount of $11.72M; FY19 other procurement funds in the amount of $2.84M; FY21 shipbuilding and conversion funds in the amount of $2.66M and FY20 research, development, test and evaluation funds in the amount of $101,058 will be obligated at time of award, of which, funds in the amount of $11.72M will expire at the end of the current fiscal year. This contract modification was not competitively procured. The Naval Sea Systems Command is the contracting activity.

17:20 EDT SunPower to replace Cimarex Energy in S&P 400 at open on 10/5 - Cabot Oil & Gas (COG) is acquiring Cimarex Energy (XEC) in a deal expected to close on October 1.

17:06 EDT DOJ says Banco Santander Consumer USA fined $134K in car lease termination suit - The Department of Justice announced that Santander Consumer USA Chrysler Capital or Santander, has agreed to pay more than $134,000 to settle a federal lawsuit alleging that the company denied early motor vehicle lease terminations to servicemembers who qualified for them under the Servicemembers Civil Relief Act, SCRA. The department previously settled an SCRA lawsuit against Santander in 2015 for repossessing the vehicles of 1,112 servicemembers without a court order. "The civil rights of servicemembers who sacrifice so much for our country must be respected," said Assistant Attorney General Kristen Clarke of the Justice Department's Civil Rights Division. "We are committed to ensuring that those serving in our nation's military receive the full range of benefits and protections that they are entitled to under the Servicemembers Civil Relief Act." Reference Link

17:03 EDT Olema Oncology announces trials in progress at AACR-NCI-EORTC - Olema Pharmaceuticals "announced a poster presentation on OP-1250, a complete estrogen receptor antagonist and a selective ER degrader being developed for the treatment of metastatic breast cancer and other women's cancers, at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, being held virtually from October 7-10, 2021. The trials in progress poster will summarize the design of the Company's ongoing Phase 1/2 open-label, first-in-human, multicenter, dose escalation and dose expansion study evaluating OP-1250 monotherapy in adult subjects with recurrent, locally advanced or metastatic ER-positive, human epidermal growth factor receptor 2-negative breast cancer. Preliminary data from the dose-escalation stage of the study are anticipated in Q4 2021."

16:51 EDT Kite submits sBLA to FDA for earlier use of Yescarta - Kite, a Gilead company, announced that it has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration for Yescarta to expand its current indication to include the treatment of adults with relapsed or refractory large B-cell lymphoma in the second-line setting. The sBLA filing is based on data from the ZUMA-7 study with the longest follow-up - over two years - of any Phase 3 CAR T-cell therapy trial. Top-line results from the primary analysis of ZUMA-7 were recently reported and showed superiority of Yescarta compared to standard of care in second-line relapsed or refractory LBCL. With a median follow-up of two years, the study met the primary endpoint of event-free survival. This represents a clinically meaningful 60% reduction in risk of EFS events versus standard of care. The study also met the key secondary endpoint of objective response rate. The interim analysis of overall survival showed a trend favoring Yescarta; however, the data are immature at this time, and further analyses are planned for the future. Detailed results from ZUMA-7 have been submitted for presentation at an upcoming medical congress. Kite is in discussions with global health authorities regarding submissions to expand the currently approved indications for Yescarta.

16:47 EDT QuickLogic announces investment by two long-time investors - QuickLogic announced two of its long-time investors have purchased, in separate private placement transactions, 198,664 shares, or 1.7% of the current shares outstanding, raising gross proceeds of approximately $1.08M. "We are honored to have long-time and committed shareholders who believe in the potential of our eFPGA business and Open-Source initiatives and are making additional investments in QuickLogic to ensure its success," said Brian Faith, President and CEO of QuickLogic. "Following the $2 million eFPGA Contract we announced earlier this month, interest in our QORC initiative has grown at a faster pace than even we had expected just a few months ago. Recognizing this positive trend, these two long-time investors reached out to us wanting to increase their investment in the Company to further demonstrate their continued support of QuickLogic. The additional capital provides the resources to continue to execute on our near-term eFPGA growth objectives and meet our profitability targets in early fiscal 2022."

16:42 EDT Kronos Bio to present preclinical data in poster on oral CDK9 inhibitor at AACR - Kronos Bio, announced that it will present preclinical data in a poster at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics. The meeting will be held from Oct. 7-10. The poster will include preclinical data on the pharmacokinetics and pharmacodynamics of KB-0742, Kronos Bio's internally discovered oral CDK9 inhibitor. The data build on results first shared at the American Association for Cancer Research, AACR, meeting earlier this year.

16:35 EDT CenterPoint Energy raises quarterly dividend to 17c per share from 16c - CenterPoint Energy, Inc.'s board of directors today declared an increase in the company's regular quarterly cash dividend from 16c to 17c per share on the issued and outstanding shares of Common Stock. This increase will be effective with the dividend payment to be distributed on December 9, 2021 to shareholders of record at the close of business on November 18, 2021.

16:34 EDT PDC Energy reports preliminary Q3 total daily production 197,000-200,000 boepd - PDC Energy announced preliminary third quarter operating results. The company anticipates total daily production between 197,000 and 200,000 barrels of oil equivalent per day and daily oil production between 63,000 and 65,000 barrels per day.

16:32 EDT Phillips 66 sets targets for reduction of greenhouse gas emissions by 2030 - Phillips 66 intends to reduce greenhouse gas emissions intensity from its operations and energy products by 2030. The company plans to reduce Scope 1 and Scope 2 emissions intensity from operations by 30% and Scope 3 emissions intensity of its energy products by 15%, below 2019 levels. Phillips 66 previously disclosed changes to its annual bonus program that are intended to reinforce its priorities around greenhouse gas emissions reductions and lower-carbon efforts. Phillips 66 will continue to invest in improving the energy efficiency of its assets. Additionally, the company plans to increase the production of renewable fuels, advance the electric vehicle battery supply chain, implement carbon capture technologies at select facilities, and participate in commercial-scale lower-carbon hydrogen production. The company has active U.S. patents in a number of areas, including biofuels, carbon capture and sequestration, fuel cells and low-carbon hydrogen.

16:22 EDT First Horizon appoints Tammy LoCascio as COO, announces further appointments - First Horizon announced that effective November 1, Anthony Restel will become President of Regional Banking and continue to serve as interim CFO until a successor is named, Tammy LoCascio will become COO and Tanya Hart will become Chief Human Resources Officer. Restel and LoCascio will continue to report to CEO Bryan Jordan and Hart will continue reporting to LoCascio. Restel is replacing Michael Brown who plans to retire to pursue personal interests and will stay until year end to help ensure a seamless transition. Restel has been COO since July, 2020 and Interim CFO since August. LoCascio has been Chief Human Resources officer since July, 2020. She joined First Horizon in 2011. Hart has been Executive Vice President of Executive Compensation and Total Rewards since January, 2017. She joined First Horizon in 1991.

16:20 EDT Welbilt stockholders approve merger with Ali Holding - Welbilt "announced that the proposal to adopt and approve the merger agreement with Ali Holding S.r.l., Ali Group North America Corporation and Ascend Merger Corp. was approved today by Welbilt stockholders with 99.72% of shares that were voted cast in favor of the pending merger. In addition, Welbilt and Ali Group have submitted regulatory filings in all required jurisdictions, including the U.S., United Kingdom, and European Union. The companies have received a second request for information from the U.S. Department of Justice which focuses on the companies' ice brands. The companies have decided that they will proceed with divesting Welbilt's Manitowoc Ice brand to address concerns raised by the U.S. Department of Justice. The companies expect to complete the sale of Manitowoc Ice in early 2022 and then close the acquisition of Welbilt by Ali Group shortly thereafter."

16:18 EDT Tarena delivers notice of intent to terminate merger with Parent and Merger Sub - Tarena International announced that it has delivered a written notice to Kidedu Holdings Limited, Kidarena Merger Sub, a wholly owned subsidiary of Parent and Ascendent Capital Partners, of the company's intention to terminate the Agreement and Plan of Merger dated April 30, 2021 with Parent and Merger Sub due to the breach of the Merger Agreement by Parent and Merger Sub. If Parent and Merger Sub fail to cure their breaches by October 30, 2021 by confirming that Parent and ACP will, respectively, take all actions and do all things necessary, proper or advisable to close the transactions contemplated by the Merger Agreement by December 31, 2021, the company intends to terminate the Merger Agreement and will be entitled to the parent termination fee pursuant to the Merger Agreement and other transaction documents. While the Merger Agreement continues in effect, the Board of Directors of the company cautions the company's shareholders and the public that there can be no assurance that the transactions contemplated by the Merger Agreement will be consummated, as substantial uncertainty exists as to whether Parent and Merger Sub will timely cure their breaches. The company will provide further updates as required by applicable law.

16:16 EDT Primo Water appoints Cate Gutowski as COO - Primo Water has appointed Cate Gutowski as Chief Operating Officer, effective October 27. Since March 2019, Gutowski held roles of progressive responsibility at Amazon Web Services, a provider of on-demand cloud computing platforms to individuals, companies, and governments. Most recently, she was the Worldwide Head of Enablement, Training, & Communications. Prior to Amazon, Gutowski worked in the aviation industry as the Senior Vice President of Global Sales and Service at Panasonic Avionics.

16:12 EDT Electronic Arts names Laura Miele COO - In a regulatory filing, Electronic Arts chairman and CEO Andrew Wilson announced the appointment of Laura Miele, who "successfully led" EA studios, as the company's COO. Blake Jorgensen, EA's COO and CFO, will begin a process to transition from EA, culminating in his departure next summer, the CEO said. Wilson also noted that Chris Bruzzo will become chief experience officer, leading the comapny's efforts to "build social ecosystems that forge stronger connections and create amazing player experiences" in EA games. Mala Singh will remains as chief people officer, Ken Moss will continue as CTO, and Jake Schatz will saty as chief legal officer. "First, Laura Miele will become our Chief Operating Officer, a critical role with elevated responsibilities to manage company-wide operations, including leadership of our strategic planning framework and ensuring we are all executing and accountable to it every day," Wilson said. "There is no one that has deeper trust and respect across our company than Laura to lead this for us. Laura successfully led EA Studios with strong strategic and operational discipline, and she will bring that focus and rigor to the entire company as COO." "After nearly a decade of impactful contributions, Blake Jorgensen has decided that this is the right moment to begin a process to transition from Electronic Arts, culminating in his departure next summer," Wilson added. "Through our time working together, Blake has been an incredible partner, advisor, and dear friend. His expertise and the team he has built have been instrumental to our growth and financial achievements, and his leadership has set us on the successful path we are on today. The internal and external search for a new CFO will begin immediately, working closely with Blake, and he will help us with the transition and onboarding when a new CFO is appointed. Thank you, Blake, for everything you've done and continue to do for our company."

16:10 EDT AnPac Bio receives noncompliance notification from Nasdaq - AnPac Bio announced that it has received a written notification from Nasdaq dated September 24 indicating that the company is not in compliance with the minimum Market Value of Listed Securities set forth in the Nasdaq Rules for continued listing on the Nasdaq Global Market. Nasdaq Listing Rule 5450 requires companies to maintain a minimum market value of $50M and Listing Rule 5810 provides that a failure to meet the market value requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the market value of the company for the 30 consecutive business days from August 12 to September 23, the company no longer meets the minimum market value requirement. This notification does not impact the listing and trading of the company's securities at this time. Pursuant to Nasdaq Listing Rule 5810, the company has a compliance period of 180 calendar days to regain compliance. If at any time during this compliance period the company's MVLS closes at $50M or more for a minimum of ten consecutive business days, Nasdaq will notify the company that it has achieved compliance with the MVLS requirement and this matter will be closed. In the event the company does not regain compliance with Rule 5450 prior to the expiration of the compliance period, it will receive written notification that its securities are subject to delisting. Alternatively, the company may consider applying to transfer its securities to the Nasdaq Capital Market. The company's business operations are not affected by the receipt of the notification letter. The company intends to monitor its market value between now and March 23.

16:08 EDT MSP Recovery enters into $3B pact to sell select healthcare claims recoveries - MSP Recovery (MSPR), which in July announced a planned business combination with Lionheart Acquisition Corporation II (LCAP), announced an agreement to monetize up to $3B of select healthcare claims recovery interests to its investment partner, Virage Capital Management LP. This initial agreement provides the platform to create a new source of revenue for MSP Recovery, the company said. The agreement gives Virage the right to buy recoveries otherwise due to MSP's assignors - up to an aggregate total of $3B. MSP's 50% share of the recovery amount remains untouched by the agreement, which now provides an additional avenue to monetize the Clients' 50% of the total recovery amount. "In the five years we have been working with Virage, they have been instrumental in helping build the scope and magnitude of our business model, having raised hundreds of millions of dollars from top notch investors," said John H. Ruiz, CEO of MSP Recovery. "We are thrilled to enter into this ground-breaking $3 billion-dollar deal with Virage. This agreement represents MSP's initial step toward realization of an additional revenue opportunity that will further support our market leadership in the healthcare recovery space. MSP is working hard to continue developing revolutionary systems that will provide never-before-seen solutions for patients, providers and payers."

16:04 EDT SmartFinancial announces sale of Richmond assets to Virginia-based First Bank - SmartBank announced that it has entered into a Purchase and Assumption Agreement, dated September 30, to sell a portfolio of loans and certain assets associated with its branch office located in Richmond, Virginia to Strasburg, Virginia-based First Bank. The terms of the Purchase and Assumption Agreement provide for First Bank to acquire approximately $83M in loans and, substantially all fixed assets related to the Bank's Richmond branch, and First Bank will also assume the facility lease. The Bank will receive a premium based on a specific percentage of the loans sold, and fixed assets will be acquired at book value. Additionally, the SmartBank employees in the Richmond branch will transition to become employees of First Bank. SmartBank will not transfer any deposit liabilities to First Bank in connection with the transaction, and SmartBank has provided notice to the relevant banking agencies that it intends to close the branch effective December 31. The Company does not anticipate that the divestiture will result in the accrual of material gains or charges upon consummation. The sale of the loans and certain assets to First Bank has been completed, and First Bank's assumption of the lease and acquisition of the remaining assets is expected to be completed in the fourth quarter, subject to customary closing conditions. The branch will continue operating as a SmartBank branch until the branch is closed on December 31.

16:03 EDT ITA to lease 31 new Air Lease aircraft - Air Lease (AL) "announced that ITA, the new national airline of Italy, has agreed to lease 31 new ALC aircraft consisting of 15 A220s, two A320neos, nine A321neos and five A330-900neos on long-term lease from ALC's orderbook with Airbus (EADSY). The 31 aircraft will deliver to the airline progressively beginning in the second half of 2022 through early 2025. In addition to these 31 ALC Airbus aircraft, ITA has signed a Memorandum of Understanding with Airbus for the purchase of 28 new aircraft: 10 Airbus A330neo aircraft for long-haul flights, seven Airbus A220 family regional jets and 11 Airbus A320neo family aircraft".

16:01 EDT Helbiz CEO acquires 200,000 units of PIPE offering - Helbiz announced that on August 9, 2021, Salvatore Palella, Founder and Chief Executive Officer of Helbiz, purchased 200,000 units of the PIPE offering which consisted of 200,000 shares of Class A Common Stock and warrants to purchase an additional 200,000 shares of Class A Common Stock for $11.50 per share. Palella commented, "Since founding Helbiz I have been fully committed to our shared success, especially now that we are publicly traded and have significant funding for our growth initiatives. Although the vast majority of my family's net worth is invested in Helbiz, I am further increasing our commitment with this additional $2 million investment, which reflects our growing optimism and confidence in the Company's prospects. Helbiz is quickly emerging as one of the leading enablers of the modern urban lifestyle. With an extensive micro-mobility network, a nascent food delivery business, and strong early traction in media and financial services, Helbiz is more than just a way to get from point A to point B -- our app is becoming a portal to the excitement and convenience of modern urban life."

15:58 EDT Avoro Capital says Merck deal undervalues Acceleron - Avoro Capital, which beneficially owns approximately 7% of Acceleron Pharma (XLRN) together with certain of its affiliates and managed funds, issued a statement that reads in part: "Despite the fact that Avoro believes that Acceleron's management team has done an excellent job at creating value for shareholders and that the company has great potential, we do not view the proposed sale of Acceleron to Merck & Co. (MRK) for $180 per share as being in the best interests of all Acceleron shareholders. Avoro believes that, first and foremost, the Merger consideration drastically undervalues XLRN... In particular, this transaction premium of approximately 38% would rank at the very bottom of the 19 comparable transactions in the biopharmaceuticals sector since the beginning of 2020, during which premiums have averaged approximately 89%. Based on our initial conversations with other market participants, it seems that the justification for the transaction and the price has been that this was the highest premium available... While we do not typically comment publicly, we feel incredibly strongly that this transaction if allowed to proceed would do a disservice to XLRN shareholders. We look forward to engaging constructively with Acceleron management, as well as our fellow investors, in order to hear other perspectives and to further articulate our rationale in the hope that we can be part of identifying a better path forward."

15:11 EDT DMV issues autonomous vehicle deployment permits to Cruise, Waymo - The California Department of Motor Vehicles has issued autonomous vehicle deployment permits to Cruise (GM) and Waymo (GOOGL), allowing the companies to charge a fee and receive compensation for autonomous services offered to the public. Unlike an autonomous testing permit, which limits the compensation that a manufacturer can receive from the public while validating the technology on public roads, a deployment permit allows a company to make its autonomous technology commercially available outside of a testing program. Commercial passenger service in an autonomous vehicle also requires authorization from the California Public Utilities Commission. The deployment authorization grants Cruise permission to use a fleet of light-duty autonomous vehicles for commercial services on surface streets within designated parts of San Francisco. The vehicles are approved to operate on public roads between 10 p.m. and 6 a.m. at a maximum speed limit of 30 miles per hour and can operate in light rain and light fog. Cruise has had state authority to test autonomous vehicles on public roads with a safety driver since 2015 and authority to test autonomous vehicles without a driver since October 2020. Waymo is authorized to use a fleet of light-duty autonomous vehicles for commercial services within parts of San Francisco and San Mateo counties. The vehicles are approved to operate on public roads with a speed limit of no more than 65 mph and can also operate in rain and light fog. Waymo has had state authority to test autonomous vehicles on public roads with a safety driver since 2014 and received a driverless testing permit in October 2018. Reference Link

15:02 EDT First Financial accelerates branch optimization plan, sees charges in Q4, 1Q22 - First Financial announced plans to optimize its banking center network as part of a plan to improve operating efficiencies and accommodate changing customer preferences. Subject to regulatory requirements, over the next two quarters the company will close and consolidate nine of its eighty-one branches. These steps are in addition to the consolidation of its Terre Haute Maple Avenue and Plaza North branches into a new, efficient, state-of-the-art facility at Lafayette Avenue and Fort Harrison Road, which occurred earlier this year, bringing the total number of closed and consolidated branches by the end of the first quarter of 2022 to ten. These consolidations which are expected to be completed over the next two quarters, are projected to save the company approximately $2.3M per year in operating expenses, commencing in the first quarter of 2022. The company expects to record pre-tax charges of approximately $1.5M during the fourth quarter of 2021 and the first quarter of 2022.

14:35 EDT Raven Industries acquires intellectual property from Loon - Raven Industries (RAVN announced that Raven Aerostar has acquired intellectual property and patents from Loon, a subsidiary of Alphabet (GOOGL,GOOG) and the developer of an autonomous constellation of high-altitude balloons for communications. In January, Alphabet announced the wind down of Loon. The 176 assets acquired by Raven are directly related to stratospheric balloon technology, including balloon navigation, launching operations and balloon manufacturing. Raven Aerostar continues to deliver key capabilities, including remote sensing, long-range communications and scientific research. "For the past nine years, Raven partnered with Loon on the development of this unique technology. Loon launched and navigated thousands of balloon platforms to help serve its mission. In parallel, we leveraged the Loon partnership and our 60 year history of balloon expertise to design and build our Thunderhead stratospheric platform," said Jim Nelson, Division Manager of Raven Aerostar. "Having the technology under one house is exceptionally valuable, especially as demand for our solutions continue to increase." The acquisition of the assets was completed on May 4.

14:24 EDT Amazon-owned Whole Foods Market CEO John Mackey to retire, COO to succeed - In a letter to Whole Foods Market team members, CEO John Mackey, said in part: "I'd like to share some news with you before it's announced publicly. September marked Whole Foods Market's 43rd anniversary (including 2 years at Safer Way-the precursor to Whole Foods) and I've decided that it's time to begin to transition my role as CEO to the next generation of leadership. I have thought long and hard about this, and while it is still surreal to write, I have decided to retire on September 1,.That is just about 11 months from today...Next September, I'll be ready to pursue some of my other life passions and I am excited to announce that our Chief Operating Officer, Jason Buechel, will become Chief Executive Officer upon my retirement. Jason is a true servant leader and champion of Whole Foods' culture and values, and he will lead the company into the future. Jason was my personal choice to replace me as the CEO and I'm pleased Amazon leadership agreed that he is the right person for the role." Reference Link

14:17 EDT MGE and FanDuel announce launch of retail sports betting in Connecticut - Mohegan Gaming & Entertainment, or MGE, and FanDuel Group, a subsidiary of Flutter Entertainment plc, announced their launch of a retail sports betting experience for residents and visitors to the state of Connecticut. "To celebrate the launch of sports betting in Connecticut, a temporary Mohegan Sun FanDuel Sportsbook retail location at Bow & Arrow Sports Bar opened to the public at 9:30am ET... After launching today in Connecticut, MGE and FanDuel will collaborate on the online casino experience under the Mohegan Sun brand, with more details on an official online launch date to be provided soon," the casino operator and sports-tech entertainment company stated.

13:27 EDT Tarena trading halted, news pending

12:40 EDT Catalyst Pharmaceuticals trading resumes

12:13 EDT Catalyst Pharmaceuticals to resume trading at 12:40 pm ET - Catalyst Pharmaceuticals is scheduled to resume trading at 12:40 pm ET, with quotation set to resume at 12:35 pm ET, according to Nasdaq.

12:03 EDT Orbital Energy appoints La Doris Harris as CDO, CEO of Orbital Solar Services - Orbital Energy Group nnounced the appointment of The Honorable La Doris Harris as the Company's Chief Diversity Officer and CEO for its subsidiary, Orbital Solar Services, effective October 1, 2021. Harris served as Director of the Office of Economic Impact and Diversity, which included the role of Chief Diversity Officer at the DOE, during President Barack Obama's administration.

12:00 EDT Kensington Capital Acquisition falls -19.8% - Kensington Capital Acquisition is down -19.8%, or -$1.95 to $7.90.

12:00 EDT Volta falls -25.8% - Volta is down -25.8%, or -$2.90 to $8.35.

12:00 EDT Onion Global rises 27.4% - Onion Global is up 27.4%, or $1.86 to $8.66.

11:52 EDT Apellis announces results from Phase 3 DERBY, OAKS studies - Apellis Pharmaceuticals announced that detailed data from the Phase 3 DERBY and OAKS studies were presented for the first time as part of two oral presentations at the Retina Society Annual Scientific Meeting in Chicago. The studies evaluated the efficacy and safety of pegcetacoplan, an investigational, targeted C3 therapy, in geographic atrophy secondary to age-related macular degeneration. GA is a leading cause of blindness that impacts more than five million people globally including one million people in the United States. In the OAKS study, monthly and every-other-month treatment with pegcetacoplan met the primary endpoint, significantly reducing GA lesion growth compared to pooled sham at 12 months. The DERBY study narrowly missed the primary endpoint, showing a reduction in GA lesion growth with monthly and every-other-month treatment compared to pooled sham at 12 months. In a prespecified analysis of the combined studies, pegcetacoplan showed a reduction in lesion growth in patients with foveal and extrafoveal lesions, with a greater effect in patients with extrafoveal lesions at baseline. Apellis plans to submit a New Drug Application for pegcetacoplan for GA to the U.S. Food and Drug Administration in the first half of 2022. "The data presented at Retina Society reinforce that pegcetacoplan is a breakthrough for patients with GA, a relentless disease that leads to blindness and has no treatment," said Charles Wykoff, M.D., Ph.D., investigator of the OAKS study and director of research, Retina Consultants of Texas. "Pegcetacoplan demonstrated a clinically meaningful treatment effect and favorable safety profile with both monthly and every-other-month dosing, highlighting the potential of pegcetacoplan to become the first treatment for GA."

11:30 EDT Disney says 'Star Wars: Galactic Starcruiser' bookings open Oct. 28 - The inaugural voyage of "Star Wars: Galactic Starcruiser" at Walt Disney World Resort will depart March 1, 2022, the company announced. General bookings for this "first-of-its-kind immersive adventure in a galaxy far, far away" open Oct. 28, the company announced. "Star Wars: Galactic Starcruiser is a vacation experience going beyond anything Disney has created before, inviting guests to become the heroes of their own stories during a two-night adventure where they see, feel and live Star Wars," Disney stated in a press release. "Some Disney and Star Wars fans, including Disney Vacation Club members, Disney Passholders and Disney Visa Cardmembers, will receive special booking opportunities ahead of the general booking date," the company added. Reference Link

11:18 EDT Gogo jumps 9% to $18.28 after issuing long-term targets

11:12 EDT D.R. Horton promotes Paul Romanowski to EVP, co-COO, effective October 1 - D.R. Horton announced the promotion of Paul J. Romanowski to EVP and Co-COO, effective October 1. In this role, Romanowski will share oversight of the company's homebuilding operations nationwide with Michael J. Murray, EVP and Co-COO, the company said in a statement. Donald R. Horton, Chairman of the Board, said, "Paul has been an essential member of the D.R. Horton management team for over 20 years. This internal promotion underscores the strength and depth of D.R. Horton's leadership and will support the Company's continued expansion of our operations, volume growth and consolidation of market share across the country."

11:10 EDT Markel says SEC, DOJ will not take action against MCIM subsidiary - Markel Corporation disclosed that as previously reported, late in the fourth quarter of 2018, the company received inquiries from the U.S. Department of Justice, U.S. Securities and Exchange Commission and Bermuda Monetary Authority into loss reserves recorded in late 2017 and early 2018 at Markel CATCo Re Ltd., an unconsolidated subsidiary managed by Markel CATCo Investment Management Ltd. that has been in runoff since June 2019. "As a result of the governmental inquiries, the company engaged outside counsel to conduct an internal review. The internal review was completed in April 2019 and found no evidence that MCIM personnel acted in bad faith in exercising business judgment in the setting of reserves and making related disclosures during late 2017 and early 2018. After completing the internal review, the company's outside counsel met with the governmental authorities and reported the findings. On September 27, 2021, the SEC notified the company that it has concluded its investigation and it does not intend to recommend an enforcement action against MCIM. On September 28, 2021, the company was advised by the DOJ that it has concluded its investigation and will not take any action against MCIM. Throughout the inquiries, the company has proactively kept the BMA informed of the status of the SEC and DOJ investigations, including the recent conclusion of those investigations. There are currently no pending requests from the BMA and it has been over a year since it has contacted the company in relation to the governmental inquiries," Markel said in a regulatory filing.

11:02 EDT Sony Interactive Entertainment to acquire Bluepoint Games - Sony Interactive Entertainment, a wholly owned subsidiary of Sony Group Corporation, announced that SIE has entered into a definitive agreement to acquire Bluepoint Games, a game developer and "long-time partner of SIE with a history of developing critically-acclaimed remasters and remakes for PlayStation consoles." Sony added: "With a relationship spanning more than 15 years, Bluepoint's expertise in high-quality world building and character creation will aid in the development of future PlayStation Studios properties... Based in Austin, Texas, Bluepoint will join the global development operation of PlayStation Studios and will be the 16th studio to join the PlayStation Studios family... The day-to-day operations post-acquisition will continue to be run by Bluepoint's current management team. Terms of this transaction including the acquisition cost are not disclosed due to contractual commitments."

10:33 EDT GM set to reach 100% renewable energy in the U.S. 5 years ahead of schedule - General Motors announced that it plans to source 100% renewable energy to power its U.S. sites by 2025 - five years earlier than previously announced, and 25 years ahead of its initial target that was set in 2016. By accelerating its renewable energy goal, GM said in a statement that it aims to avoid 1 million metric tons of carbon emissions that would have been produced between 2025 and 2030. "We know climate action is a priority and every company must push itself to decarbonize further and faster," said GM Chief Sustainability Officer Kristen Siemen. "That's what we are doing by aiming to achieve 100% renewable energy five years earlier in the U.S. as we continue to advance on our commitment to lead an all-electric, carbon-neutral future." The company has committed to invest $35B in electric and autonomous vehicles and plans to introduce more than 30 electric vehicle models globally by 2025, GM added.

10:01 EDT DoorDash, Dream Diners announce meal kit delivery partnership - Dream Diners and DoorDash announced a new partnership that will make Dream Dinners' family meal kits available on-demand for the first time. Dream Dinners operates 69 franchised and company-owned local kitchens in 22 states. Co-founder/CEO Tina Kuna is credited with creating the retail meal prep concept in suburban Seattle in 2002. Local Dream Dinners kitchens are offering DoorDash customers a box of three ready-to-cook medium meals, which feed up to three people for $75 (fees apply), or three large meals, which feed up to six, for $150 (fees apply). Customers choose from five family-friendly options. "As Dream Dinners heads into our 20th year, we are excited to partner with DoorDash as its first national meal kit offering on the Marketplace," Kuna said. "This opportunity allows us to reach a new, younger customer base, increase our brand awareness and serve a wider audience of families as they gather around the table and enjoy pre-prepped homemade meals."

10:00 EDT Kohl's falls -12.4% - Kohl's is down -12.4%, or -$6.67 to $46.99.

10:00 EDT Perrigo rises 12.0% - Perrigo is up 12.0%, or $5.21 to $48.71.

10:00 EDT Regal Beloit rises 101.5% - Regal Beloit is up 101.5%, or $76.72 to $152.33.

09:51 EDT Hexion Holdings announced plans to form two independent companies - Hexion Holdings announced yesterday its plan to separate into two independent companies. The two companies will be Hexion Holdings, composed of the company's Adhesives and Versatic Acids and Derivatives product lines, and Hexion Coatings and Composites, composed of Hexion's former epoxy-based Coatings and Composites products. The latter will be renamed at a later date. Hexion anticipates that the HCC separation transaction will be in the form of a distribution of 100% of the stock of HCC, a new and independent company to current holders of Hexion Holdings common stock and warrants. Upon completion of the HCC spin, current Hexion Holdings shareholders will own shares of both Hexion Holdings and HCC. Hexion Holdings generated historical net sales of $2.5B and pro forma net sales of approximately $1.4B for the year-ended December 31, 2020. Hexion is "expected to maintain appropriate debt levels going forward." HCC generated total sales of approximately $1.1B for the year-ended December 31, 2020. HCC is "expected to maintain appropriate debt levels going forward."

09:47 EDT AbbVie presents long-term efficacy and safety data on Skyrizi - AbbVie presented results from new Phase 3 data analyses of KEEPsAKE-1 and KEEPsAKE-2, evaluating risankizumab, or Skyrizi, 150 mg in adults with active psoriatic arthritis for one year. These results were featured during the "Late Breaking News, Reviews and Updates" session at the 30th European Academy of Dermatology and Venereology, or EADV, Virtual Congress. The new long-term data from the open-label extension period showed that 70 and 58% of patients initially treated with risankizumab achieved American College of Rheumatology 20, or ACR20, response in KEEPsAKE-1 and KEEPsAKE-2 respectively at one year, where patients with missing data were categorized as non-responders. Among patients initially treated with risankizumab, 43% in KEEPsAKE-1 and 32% in KEEPsAKE-2 achieved ACR50 response, and 26% in KEEPsAKE-1 and 17% in KEEPsAKE-2 achieved ACR70 response at one year. Additionally, at one year, 68 and 64% of patients initially treated with risankizumab and with a body surface area greater than or equal to 3 percent at baseline achieved a 90% reduction in the Psoriasis Area and Severity Index in KEEPsAKE-1 and KEEPsAKE-2, respectively.

09:47 EDT Kohl's falls -9.9% - Kohl's is down -9.9%, or -$5.30 to $48.36.

09:47 EDT Perrigo rises 15.8% - Perrigo is up 15.8%, or $6.86 to $50.36.

09:47 EDT Regal Beloit rises 101.9% - Regal Beloit is up 101.9%, or $77.02 to $152.63.

09:33 EDT Nevada reports August statewide gaming win up 56.9% to $1.17B - Nevada reports August Las Vegas Strip gaming win up 97.22% compared to 2020 to $625.69M. Publicly traded companies in the casino and betting space include Boyd Gaming (BYD), Caesars (CZR), Churchill Downs (CHDN), DraftKings (DKNG), Flutter Entertainment (PDYPY), Gan Limited (GAN), Las Vegas Sands (LVS), MGM Resorts (MGM), Penn National (PENN), William Hill (WIMHY) and Wynn Resorts (WYNN).

09:30 EDT Adial expects to complete ONWARD Phase 3 trial of AD04 in 1Q22 - Adial Pharmaceuticals announces that greater than 50% of patients expected to complete the ONWARD Phase 3 trial evaluating AD04 as a therapeutic agent for the treatment of Alcohol Use Disorder in persons with certain target genotypes related to the serotonin transporter and receptor genes have completed the full, 24-week, treatment period. ONWARD is a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, pivotal Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of AD04 in patients with AUD and selected polymorphisms in the serotonin transporter and receptor genes. The intended primary endpoint for analysis of efficacy is the change from baseline in the monthly number of heavy drinking days during the last 8 weeks of the 24-week treatment period, where heavy drinking is defined as the consumption of 5 or more drinks/day for men and 4 or more drinks/day for women. Drinking levels are self-reported using the timeline follow-back method. The TLFB method is a daily calendar for alcohol consumption and employs memory aids to prompt recall. The TLFB has been used extensively in pharmacotherapy trials for AUD and other substance abuse disorders. Baseline is the 4-week period prior to the screening visit. For each subsequent clinic visit, alcohol consumption is recorded as the number of drinks per day. Patients have been randomized based on a one-to-one ratio, so that approximately 50% of enrolled patients will be in the placebo group and 50% in the AD04 group. Both placebo and active clinical trial material were manufactured in two batches of equal amounts and are light-yellow, oval tablets for oral administration with each tablet weighing approximately 80 mg. Placebo and active tablets are indistinguishable from each other. The active tablets have 0.33 mg of AD04's active ingredient, Ondansetron, in place of a similar volume of excipient in the placebo. They have been packaged in blister-packs of 18 tablets, which allows for 7-days of dosing plus 2-days extra to allow for flexibility in appointment scheduling. During packaging, the clinical trial material was coded so that neither the Company, the doctors, nor the patients can determine whether a package contains placebo or active tablets. Adverse events are monitored by the Company's Chief Medical Officer; Crown CRO, and the trial's Data Monitoring Committee. Clinical trial material can be unblinded in the event one of these safety reviewers determines unblinding is necessary to ensure the safety of any particular trial patient on a case-by case basis. To date, no situations have arisen where it was determined unblinding would be warranted, and therefore, no trial patients have had their dosing unblinded to determine if they were taking placebo or active tablets. ONWARD is being conducted in 25 clinical sites in six countries in Scandinavia and Central and Eastern Europe: Sweden, Finland, Poland, Latvia, Bulgaria and Croatia. The Coordinating Principal Investigator is Professor Hannu E.R. Alho, Emeritus Professor of Addiction Medicine at the University of Helsinki. Patients are genetically screened prior to enrollment in the ONWARD trial so that only genetically positive patients are enrolled. A total of 1216 people were genetically screened with 403 showing genetic positivity for the AD04 target genotypes. Behavioral therapy is administered to all trial patients so that the placebo or drug will be an adjunct therapy to behavioral therapy. This was required by the regulatory authorities because behavioral therapy is considered the standard of care. A successful approval would therefore likely result in a label stating that AD04 should be administered in combination with behavioral therapy. This would be expected to be similar to psychiatric drugs, such as anti-depressants. The Company agreed that use of a standardized counseling protocol in the trial would be important and the Company's Chief Medical Officer provided training for all clinical sites to administer the behavioral therapy. All clinical sites have been certified for using this protocol. In order to qualify for enrollment in ONWARD, in addition to having the genotype, patients had to meet the following additional requirements, among others: Male or female over the age of 18 years old; Qualify as having AUD under the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; Have experienced 6 or more heavy drinking days in the previous 4 weeks; Have not been abstinent for more than 14 days in the previous 4 weeks; and Expression of a desire to reduce or stop alcohol consumption; Patients meeting the above inclusion criteria were rejected for enrollment in ONWARD based on the following key criteria, among others: Withdrawal symptoms requiring medical intervention at either the screening of baseline visit; Diagnosis of any of the following concomitant psychiatric disorders: non-treated, unstable schizophrenia, bipolar disorder, other psychotic disorder during the lifetime of the patient; Recentdiagnosis of a major depressive disorder, post-traumatic stress disorder, panic disorder or eating disorder; Current or recent treatment with antipsychotics or antidepressants medications, which can have an effect on serotonin receptor or transporter actions, or opiate antagonists, glutamate antagonists, anticonvulsants, serotonin reuptake inhibitors, serotonin antagonists, other antidepressants , dopamine antagonists, and disulfiram; Clinically significant untreated and unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance; Clinically abnormal ECG or significantly abnormal vital signs; Clinically significant hepatic disease; and; Positive pregnancy test; The ONWARD Phase 3 clinical trial commenced with the opening of a site in Finland in February 2020, and 302 patients have been enrolled. Enrollment was closed on August 30, 2021 immediately after the 302nd patient was randomized for placebo or active treatment and completed the first treatment visit. Since each trial patient undergoes approximately 24 weeks of treatment, the last patient should complete dosing in February 2022. Each patient receives a follow-up call approximately 4 weeks after completing of the full treatment cycle to collect additional safety and tolerability information. As of the week ending September 24th, 120 patients had successfully completed their participation in the trial, 60 patients had discontinued participation in the trial prior to completion, and 122 patients are still being dosed in the trial. As stated above, the last of these patients is expected to complete dosing in February 2022. Patient retention rates continue to exceed projections. As each ONWARD trial site discharges its last patient, the Company will work expeditiously to resolve any outstanding data queries at each site so that it can be closed upon the last follow-up call 4 weeks later. Once the last patient completes his or her final dose, which is expected in February 2022, the Company anticipates closing the last site within 6 weeks. Following closure of the last site, the database containing all the information will be "locked," meaning it can no longer be changed; the trial will be unblinded so that it will be known for each patient whether the patient received placebo or active tablets; and data analysis will commence by the Company's outside statisticians. Results will be released expeditiously, likely within a few weeks of the last site closure.

09:21 EDT Shift Technologies appoints Jeff Clementz as President - Shift (SFT) announced that Jeff Clementz, recent SVP, GM of Walmart (WMT) US Marketplace and Partner Operations, will be appointed as Shift's President, effective Oct. 1, 2021. Clementz brings over twenty years of experience leading payments and marketplace businesses.

09:20 EDT Roku announces This Old House to premiere new seasons - Roku announced Emmy Award-winning series This Old House and Ask This Old House will premiere new seasons of both top-rated shows starting Thursday, September 30th. For the first time in its 43-year history, the 2021-22 season will feature 39 episodes of each show - 13 more episodes than previous seasons. New episodes will premiere on PBS as well as an all-new dedicated This Old House premium subscription channel on The Roku Channel on Thursdays. Viewers will be able to stream new episodes for free on demand on The Roku Channel the following Mondays.

09:18 EDT Financial firms join TNFD to build nature-related risk management framework - Senior executives from across financial institutions, corporates and market service providers representing major global markets have been selected to serve for two years as Members of the Taskforce on Nature-related Financial Disclosures. Led by TNFD Co-Chairs Elizabeth Mrema, United Nations Assistant Secretary General and Executive Secretary of the UN Convention on Biological Diversity and David Craig, Former CEO of Refinitiv and Strategic Advisor to London Stock Exchange Group, the Taskforce Members are convening for the first time on the 6th of October to kick off their work developing and delivering a risk management and financial disclosure framework to support a shift in global financial flows away from nature-negative outcomes and towards nature-positive outcomes. The finalised framework is earmarked for release in late 2023. However, a draft beta version will be circulated in early 2022 to be tested and refined via an open-innovation approach with market participants throughout next year. The 30 Taskforce Members have been selected for their sector and geographical coverage and their individual subject-matter expertise across nature and finance that can support TNFD's mission. The Members represent sectors with the largest impact and dependencies on nature, such as agribusiness, the blue economy, food & beverage, mining, construction, infrastructure and others, and are globally representative coming from 14 countries across 5 continents. The Taskforce membership will ultimately consist of up to 35 individuals. Selection of the remaining senior executives is currently underway, bringing in further specialists from sectors and geographies to broaden the Taskforce's geographic and sector coverage and its diversity of expertise. Taskforce members in the TNFD include executives from Bank of America (BAC), Axa (AXAHY), BlackRock (BLK), BNP Paribas (BNPQY), HSBC (HSBC), Swiss Re (SSREY), UBS (UBS), AB InBev (BUD), Anglo American (NGLOY), GSK (GSK), and Nestle (NSRGY). Reference Link

09:17 EDT Franklin Resources buys quantitative asset firm O'Shaughnessy Asset Management - Franklin Resources announced that it will acquire O'Shaughnessy Asset Management, a quantitative asset management firm. Through this acquisition, Franklin Templeton adds to its offerings in the high growth separately managed account industry, where it is already one of the largest providers with $130B in SMA assets under management as of August 31. OSAM's capabilities, both as a factor-based investment manager and as a Custom Indexing solution via OSAM's flagship Canvas platform, will serve as an important expansion and enhancement of Franklin Templeton's existing strengths in SMA and custom solutions capabilities. The Canvas platform launched in late 2019 and has seen strong growth since its inception, now representing $1.8B of OSAM's total $6.4B in assets under management as of August 31. Canvas also provides the opportunity for advisors to efficiently plan, set tax budgets, identify realized and unrealized gains and losses, and systematically sell certain positions to create offsets. OSAM is also regarded as a pioneer in factor-based investing with a long history of delivering its investment strategies through SMA and mutual fund solutions. Through this transaction, OSAM's more than 40 team members are expected to join Franklin Templeton along with all of the necessary intellectual property, investment management processes, and principal business assets necessary to evolve and grow the business within the Franklin Templeton Product Solutions group. The transaction is subject to customary closing conditions and expected to close in the fourth quarter of calendar year 2021.

09:17 EDT Illumina opens entities in Colombia and Mexico - Illumina announced the creation of Illumina Colombia and Illumina Mexico Productos de Biotecnologia. Colombia S.A.S. will be located in Bogota, Colombia. The entities will help advance Illumina's clinical business in Colombia and Mexico, with a focus on key healthcare systems and hospitals. In addition, the entities will support local and nearby Illumina channel partners across Latin America, including countries in the Caribbean, Central America and South America.

09:15 EDT Limonetik selects Nuvei to enhance marketplace payment capabilities - Nuvei Corporation announced an agreement with Limonetik. The move will enable Limonetik to enhance its marketplace payment services offering in Europe, as the company looks to embark on its international expansion strategy. Through this collaboration, Limonetik will leverage Nuvei's European acquiring services and plans to incorporate international acquiring as part of its global expansion. This enables its wide portfolio of marketplace platform clients to accept an even broader range of payments, while taking advantage of Nuvei's powerful authorization optimization features to enhance acceptance rates.

09:13 EDT Churchill Downs announces historical racing machine expansion in Kentucky - Churchill Downs announced plans to open a new historical racing machine, or HRM, entertainment venue, Derby City Gaming Downtown, in Louisville, Kentucky. The 43,000-square-foot entertainment venue will be located at 140 South 4th Street, at the corner of South 4th and West Market, diagonal to the Kentucky International Convention Center. Derby City Gaming Downtown will initially include 500 HRMs, a gaming area and over 200 onsite parking spaces. The new entertainment venue will provide guests three bar concepts. A retail and merchandise store will be located on the street level where guests can shop for Kentucky Derby-themed merchandise. Construction on Derby City Gaming Downtown will begin later this year with an anticipated opening date in early 2023. The investment in the new entertainment venue will create 450 jobs for the local economy, including 350 construction jobs and more than 100 new permanent jobs. CDI also announced a pledge of $1M to the West End Opportunity Partnership, a collaborative community-led initiative that will finance projects to kick start economic development and quality of life improvements in a district comprised of nine West End neighborhoods. "CDI is committed to investing in the city of Louisville and today we are particularly excited to announce this new downtown entertainment venue," said Bill Carstanjen, CEO of CDI. "Our HRM expansion will be a win for the entire community in the Louisville area and will create $10 to $12M per year in additional purse money for Churchill Downs Racetrack. It is important that Louisville is a city that is thriving - a great place to live, work and visit and we are committed to helping create economic vibrancy for every area of our community. The West End Opportunity Partnership and our collaboration with OneWest can help us responsibly and sustainably achieve that vision."

09:11 EDT Nvidia partners with Electronic Arts to bring games to GeForce NOW - NVIDIA (NVDA) announced that Electronic Arts (EA) is bringing more of its hit games to the NVIDIA GeForce NOW cloud gaming service, beginning with Battlefield 1 Revolution, Mirror's Edge Catalyst, Unravel Two, Dragon Age: Inquisition and Apex Legends. GeForce NOW membership has more than doubled in the last year, giving Electronic Arts access to more than 12 million gamers. Collectively, over 20 million hours of gameplay are streamed each month via GeForce NOW, from 30 data centers in more than 70 countries.

09:10 EDT Magal Security completes name, ticker symbol change - Senstar Technologies (SNT) announced that as of September 30, its ordinary shares will be traded under its new name, Senstar Technologies, following the name change from Magal Security Systems (MAGS). In addition, the company also announced that its common stock will begin trading under ticker symbol "SNT" on the Nasdaq Capital Market at the opening of the market on September 30. The company implemented the name and ticker symbol change in conjunction with the divestiture of its Integrated Solutions Division as part of its strategic decision to focus primarily on the company's product division. The divestiture was completed on June 30.

09:09 EDT Bragg says Spin Games awarded Connecticut online gaming service provider license - Spin Games announced that the State of Connecticut Department of Consumer Protection has granted the Company an Online Gaming Service Provider license pursuant to Connecticut General Statutes Public Act 21-23. This license enables Spin, upon receiving approvals for complying with the state's technical standards, to deploy its ROC Remote Gaming Server platform and its online content via State-approved online gaming operators when they go live later this year. Connecticut received final approval from the U.S. Bureau of Indian Affairs to the revisions it made to the current gaming compacts between the State, the Mashantucket Pequot Tribe and the Mohegan Tribe earlier this month, and Connecticut Governor Ned Lamont anticipates that online gaming will be available as early as October.

09:09 EDT Microsoft launches Xbox Cloud Gaming in Australia, Brazil, Japan, Mexico - Microsoft announced that Xbox Cloud Gaming as part of Xbox Game Pass Ultimate is launching in Brazil and Mexico later Thursday, and Australia and Japan on October 1, as announced at Tokyo Game Show. "With the expansion of Xbox Cloud Gaming to gamers in Australia, Brazil, Japan and Mexico, we're now opening the opportunity for over one billion people in 26 countries across five continents to be able to play Xbox Game Pass games from the cloud on their phones, tablets and PCs," the company said. "Since cloud gaming is powered by custom Xbox Series X consoles, that means these games are being played on an Xbox in the cloud, bringing faster load times and improved frame rates to the gameplay experience." Reference Link

09:07 EDT Canoo and AVL partner to build proprietary Electric Vehicle software - Canoo announced a partnership to develop, test and validate Advanced Driver Assistance Systems software for Canoo's Lifestyle Vehicle. The technology provides a human interface that gives vehicle feedback to notify drivers to make safer choices on the road. The software will be owned by Canoo, beginning with the Lifestyle Vehicle. The engineering services AVL will provide Canoo with include software development of 13 ADAS features comprising SAE Level 2 such as lane centering and adaptive cruise control. Canoo's Lifestyle Vehicle - its first product to market - will start production in late 2022 and have Level 2 ADAS functionality at launch.

09:06 EDT Oscar Health teams with four Chicago area health systems - Oscar Health announced that it's partnering with four leading Chicago area health systems: Edward-Elmhurst Health, Loyola Medicine, NorthShore University HealthSystem, and University of Chicago Medicine. These partnerships will make Oscar's Individual and Family health insurance plans available to individuals across Chicago beginning 2022, including Cook, Lake, and DuPage counties, pending regulatory approval.

09:05 EDT Katapult announce its lease-purchase solution, integration with Salesforce Cloud - Katapult announced that it has launched its eCommerce point-of-sale lease-purchase solution through an integration with Salesforce Commerce Cloud. Now retailers can deliver unified experiences for their customers that extend beyond commerce to include marketing, customer service and more. Katapult's technology integrates with online platforms to retailers across several industries and funding is quick so retailers can spend their energy focused on attracting new customers and growing, while consumers get an enhanced checkout experience. Katapult's lease-purchase solution provides consumers with no credit or developing credit a way to access their retail partners' durable goods products and obtain what they need when they need it. Retail partners who have implemented Katapult's solutions have seen an expanded customer base, increased transactions, and improved customer loyalty. With access to Commerce Cloud, retailers will experience a streamlined integration process, allowing them to offer a lease-purchase checkout option through Katapult.

09:04 EDT Smith & Wesson Brands to relocate headquarters to Tennessee in 2023 - Smith & Wesson Brands announced that it is moving its headquarters and significant elements of its operations to Maryville, Tennessee in 2023. Smith & Wesson has been based in Springfield, Massachusetts since the company was incorporated in 1852. Smith & Wesson will also close facilities in Connecticut and Missouri as part of consolidating in Tennessee. This process will result in the company reducing the number of locations it maintains from four to three and will significantly streamline its manufacturing and distribution operations. The company emphasized that the move will not begin until 2023 and will not have an impact on employees' jobs until then. Total investment in the project is estimated at $120M, will be funded from cash on hand, and is expected to be accretive to EPS by 10c-12c per year once fully operational. Construction in Maryville, Tennessee is expected to begin in the calendar fourth quarter of 2021 and be substantially complete by the summer of 2023.

09:04 EDT Summit presents further insights on novel mechanism of action of ridinilazole - Summit Therapeutics is displaying a ePoster at IDWeek 2021. Summit's ePoster provides enhanced details regarding the newly discovered novel mechanism of action of ridinilazole. The ePoster will be available throughout IDWeek 2021, which takes place between September 29 and October 3, 2021. Ridinilazole is Summit Therapeutics' investigational first-in-class drug that recently completed enrollment of a Phase III clinical trial, Ri-CoDIFy. The primary endpoint of this trial seeks to demonstrate the superiority of ridinilazole in sustained clinical response as compared to vancomycin. Ridinilazole is not currently approved for use by any regulatory authority. Summit's poster presentation provides demonstrable scientific evidence of ridinilazole's novel mechanism of action which involves binding to the minor groove of Clostridioides difficile bacteria's DNA. This is believed to be the primary mechanism through which ridinilazole elicits its bactericidal action against C. difficile bacteria. Ridinilazole has a novel mechanism of action and is the first of a new class of antibiotics: this is consistent with the World Health Organization's recommendation for developing antibiotics with novel mechanisms of action or that are new classes of drugs, which it considers a key point in overcoming existing bacterial resistance. Our updated research, through collaboration with the University of Houston, provides new images from high-resolution confocal microscopy. This technique has allowed intracellular visualization of ridinilazole binding to DNA within C. difficile and confirms this novel mechanism of action. Ridinilazole, if approved, has the potential to be the first antibiotic with a novel mechanism of action approved in over ten years.

09:03 EDT Philips signs long-term stratefic partnership with Main Line Health's Lankenau - Royal Philips and Lankenau Heart Institute, part of Main Line Health, announced they have entered a five-year strategic partnership focused on integrated cardiovascular solutions. Working together, Philips and Main Line Health will develop an ecosystem of clinically-enabled cardiovascular solutions that will allow Main Line Health to standardize and integrate technology across its network. In addition, the partnership aims to help Main Line Health drive predictability and consistency in costs, as well as focus on clinical and technical training. "By partnering with Philips, we will be able to continue our world-class cardiovascular care system-wide, including fully renovating and installing state-of-the-art Philips equipment to provide advanced cardiovascular and neuro care at Bryn Mawr Hospital and Paoli Hospital," said William Gray, MD, System Chief, Cardiovascular Diseases, Main Line Health and Co-director, Lankenau Heart Institute. "This will allow us to define a strategy for the future, adopting novel technology as it evolves." This long-term strategic partnership will uniquely focus on integrated cardiovascular solutions. As part of the partnership, a dedicated team of Philips solutions architects will work collaboratively with Main Line Health to understand their challenges and develop technology plans around the cardiovascular service line. These technology plans are tailored to their needs with three objectives in mind: clinical, operational and business model innovation.

09:02 EDT Perforce to acquire BlazeMeter Continuous Testing platform from Broadcom - Perforce Software, backed by Clearlake Capital Group and Francisco Partners, announced that it has agreed to acquire the BlazeMeter Continuous Testing platform from Broadcom. Financial terms were not disclosed. Completion of the acquisition is subject to customary closing conditions, and the transaction is expected to close in October.

08:51 EDT Cathie Wood's ARK Investment bought 210K shares of Kratos Defense on Wednesday

08:50 EDT Workhorse Group announces new executive leadership appointments - Workhorse Group (WKHS) announced executive leadership appointments to support its go-forward operating and commercial plans.The leadership changes announced include: Greg Ackerson, Workhorse's Corporate Controller, has been appointed interim Chief Financial Officer, effective immediately, and will report to Dauch. He succeeds Steve Schrader, who has left the Company. Mr. Schrader's departure is not based on any disagreement with the Company's accounting principles or practices or financial statement disclosures. Jim Harrington, who formerly served as Senior Vice President, General Counsel, Secretary and Chief Compliance Officer at Delphi Technologies, has been appointed as the Company's Chief Administrative Officer, General Counsel and Secretary, effective August 16, 2021, and reports to Dauch. Josh Anderson, who most recently served in several capacities including as Founder and President of Leiten, President of RexRover, and President of DESCH Systems, has been appointed Chief Technology Officer, a newly created role responsible for managing and overseeing the development and implementation of Workhorse's advanced technology into its products, effective September 21, 2021, and reports to Dauch. Jim Peters, formerly Executive Director of Procurement and Supplier Quality Worldwide Operations-Powertrain at American Axle & Manufacturing (AXL), has been named Vice President, Purchasing and Supply Chain, effective September 1, 2021, and reports to Dauch. Dave Bjerke, former President of Triad Services Group, has been appointed Vice President, Product Development, effective September 27, 2021, and reports to Ryan Gaul, President of Commercial Vehicles. Rob Willison, Chief Operating Officer, has left the Company, effective immediately. The Company is eliminating the role of Chief Operating Officer.

08:47 EDT Nomad Foods closes accretive acquisition of Fortenova Group's frozen food unit - Nomad Foods announced that it has completed its previously announced acquisition of Fortenova Group's frozen food business for a purchase price of approximately EUR 615M. The acquisition of Fortenova Frozen is expected to be high-single digit % accretive to Adjusted EPS in year 1, before synergies, and result in 2021 Adjusted EPS above $2.00 per share on a combined and annualized basis. Based on strong performance year-to-date, Fortenova Frozen is expected to achieve mid-single digit revenue growth and Adjusted EBITDA slightly ahead of the prior expectation of EUR 53M in 2021 on a full year basis. Management continues to see an opportunity for Adjusted EBITDA to grow by approximately 50%, driven in part by an estimated EUR 15M of annual run-rate synergies by 2024 through a combination of scale, operational excellence, commercial optimization, and expense management.

08:45 EDT ElectraMeccanica SOLO EV selected as exclusive vehicle during Canadian E-Fest - ElectraMeccanica Vehicles announced that its flagship SOLO EV has been selected as the exclusive vehicle used in a celebrity race on July 1st, 2022 at the Canadian E-Fest, a three-day festival that showcases the latest projects in the EV space. The Canadian E-Fest-which includes various events such as a sustainability conference, concerts, a variety of fan experiences and a celebrity race-precedes the 2022 Vancouver E-Prix, an all-electric international street-racing series culminating in the ABB FIA Formula E World Championship on July 2, 2022. The celebrity race will compete in ElectraMeccanica's SOLO EV - an all-electric, single-seat, three-wheeled electric vehicle that is revolutionizing the urban driving experience. "Our participation as the exclusive vehicle for the celebrity race at the Canadian E-Fest is a testament to the fun and unique driving experience that our flagship SOLO EV provides," said Kevin Pavlov, CEO of ElectraMeccanica. "Formula E is the premier zero-emissions racing series globally and our partnership through the Canadian E-Fest -which is just a short distance from our headquarters in Vancouver, Canada- is an excellent way to support this purpose-driven, global initiative towards vehicle electrification."

08:44 EDT Aspen Group director Douglas Kass buys 11.8K shares of common stock - In a regulatory filing, Aspen Group disclosed that board member Douglas Kass bought another 11.8K shares of common stock on September 28th in a total transaction size of $63.5K, boosting his stake by about 12%. Shares of Aspen Group are up 2.4% at $5.47 per share in pre-market trading.

08:42 EDT Arcutis Biotherapeutics announces new data on roflumilast - Arcutis Biotherapeutics announced new patient-reported outcome data that show topical roflumilast provides significant reductions in itch, a common and bothersome symptom of multiple dermatologic conditions. Once-daily roflumilast cream reduced both the severity and burden of itch, and improved quality of life, in the DERMIS-1 and DERMIS-2 Phase 3 pivotal studies in chronic plaque psoriasis. In addition, in two separate Phase 2 studies, topical roflumilast foam showed a robust and rapid reduction of itch in scalp and body psoriasis and seborrheic dermatitis. Dr. Melinda Gooderham presented patient-reported outcome data from the DERMIS studies in patients with chronic plaque psoriasis treated with roflumilast cream that showed the mean reduction in Worst-Itch Numeric Rating Scale, or WI-NRS, score was significantly greater with roflumilast cream than vehicle at all study timepoints, with improvements achieved as early as two weeks. In addition, more than two-thirds of patients with a WI-NRS of four or greater at baseline achieved a reduction of four-points or more with roflumilast cream compared to less than one-third of individuals using vehicle at week 8. Overall quality of life was also improved with the use of once-daily roflumilast cream as measured by the Dermatology Life Quality Index with an improvement of 65.2% from baseline in the DLQI score for roflumilast cream vs 12.7% vehicle in DERMIS-1 and a 69.4% improvement from baseline DLQI score roflumilast cream vs 9.0% vehicle in DERMIS-2. In a separate poster presentation highlighting results from the Phase 2 randomized, double-blind, vehicle-controlled study of roflumilast foam in patients with plaque psoriasis on the scalp and body, 68.2% of patients with a WI-NRS score of four or greater at baseline using roflumilast foam achieved a four point or greater reduction in WI-NRS compared to only 23.1% of patients using vehicle at week eight. These results are consistent with that observed specifically in the scalp with 71.0% of patients with a baseline Scalp Itch, or SI,-NRS of four or greater at baseline achieving a four-point or greater improvement in SI-NRS as compared to 18.5% in the vehicle treated group. Likewise, data presented in a poster presentation from a Phase 2 study of patients with seborrheic dermatitis showed approximately 64.6% of patients with a WI-NRS score of four or greater at baseline using roflumilast foam achieved a four point or greater reduction in WI-NRS compared to only 34.0% of patients using vehicle at week eight. In these studies, both roflumilast cream and roflumilast foam met their primary endpoints and were generally well-tolerated.

08:41 EDT Logiq engages The Benchmark Company to explore restructuring initiative - Logiq has engaged The Benchmark Company to assist Logiq in a recently announced restructuring initiative for enhancing shareholder value. These alternatives could include, among others, mergers and acquisitions for Logiq's DataLogiq business, which provides data-driven, end-to-end e-commerce marketing solutions. It could also include the spinoff of Logiq's AppLogiq business into another public or private company, IPO or trade sale. AppLogiq includes PayLogiq e-Wallet, GoLogiq hyper-local food delivery, and other mobile e-commerce solutions, as well as a recently announced mobile fintech platform for microlending.

08:40 EDT Evercel, Inc responds to 'misstatements' by former chairman James Gerson - Evercel, Inc. issued a statement in response to misstatements contained in James Gerson's latest statement to the public. The statement read in part, "As we have written to you in recent weeks, Evercel and its board are keenly focused on taking steps to move into the future to build shareholder value. These include significant and positive steps forward, including closing the ZAGG transaction earlier this year, moving towards a listing on the OTCQX market for greater liquidity and frequent reporting and the recently approved $20 million share repurchase program. We continue to believe that the last thing the Company needs is a costly, distracting and disruptive proxy contest. Sadly, however, the wealthy 78-year-old former Chairman Jim Gerson, who was forced to resign from the Company, is continuing to try and drag the Company backward, issuing vindictive, mudslinging diatribes in press releases designed to distract you from the truth. We do not wish to engage in a prolonged war of words - but because your vote is important, we believe it is yet again necessary to clarify a few key points as you consider how to vote at the upcoming annual meeting: Mr. Gerson's effort is motivated by his personal vendetta to gain outsized influence over Evercel after resigning as a result of his own actions. Mr. Gerson misleadingly claims his campaign is "not about Jim Gerson," but the fact is that he is trying to change the bylaws to expand the Board so he-who owns less than 12% of Evercel's outstanding shares-can install his long-time friends-who own a negligible number of shares-as directors and control half of your Board. Giving Mr. Gerson this sort of outsized influence would disrupt the functioning of the Board, and we believe it is likely to result in the departure of management, who would be trapped in a dysfunctional environment, leaving the Company with no path forward to source or manage new investments. Mr. Gerson's resignation was not truly voluntary. Mr. Gerson had no choice but to resign to avoid a formal investigation into his conduct. All directors-other than his long-time collaborator Mr. Krantz-who were on the Board at the time of his resignation can confirm that Mr. Gerson's version of events is pure fabrication. Mr. Gerson's effort to pretend his departure was truly voluntary is simply untrue and exemplifies his lack of honesty and credibility. Mr. Gerson's track record is one of value destruction at Evercel. It makes no sense for Mr. Gerson to ask shareholders to trust him and his friends with Evercel's future without holding him accountable for his own track record. The fact is that before the current CEO joined Evercel, Jim Gerson oversaw the Company, and during that time Evercel's share price decreased 59.7%, Evercel's assets dwindled to only $18 million and Evercel's stock was delisted. Mr. Gerson negotiated and approved the current CEO compensation program, which is standard in the investment community and has helped build value. Mr. Gerson now implies that there is something wrong with the way CEO compensation works at Evercel, which includes a negligible base salary for running Evercel. Yet he fails to mention that most of the compensation does not come from Evercel, is based on the performance of the Company's investments and is standard in the investment community - which is why Mr. Gerson proposed and then approved it in the first place. The current Board is dedicated to shareholder interests, not their own, and is excited to pursue a plan that will continue to build value. This includes maximizing the value of Evercel's assets, pursuing new, value creating opportunities, providing more timely financial reporting, listing on the OTCQX market and returning capital to shareholders through the recently announced share repurchase program. We ask that you not derail this progress. "

08:38 EDT Safe-T completes development of iShield - Safe-T Group announced it has completed the development of iShield, an advanced cybersecurity product designed to help consumers as well as small and mid-sized businesses in detecting and defending against dangerous and malicious threats during online browsing activities. The first version of iShield is expected to launch by the beginning of 2022 and will include protection of consumers' personal data and identity, control of consumers' web footprints, encrypted browsing and safe keeping of consumers' devices. iShield will be offered to users through a recurring monthly or yearly subscription-based pricing model.

08:37 EDT Moderna selects Alexandria Real Estate for new headquarters - Moderna (MRNA) has selected Alexandria Real Estate (ARE) to develop, operate and construct its new corporate headquarters and core R&D facility on the Alexandria Center at One Kendall Square mega campus in Cambridge, Boston. This development is expected to eliminate most of the fossil fuel consumption for building heating and enable the building to operate as a net-zero energy commercial laboratory facility. The building is targeting LEED Platinum Core & Shell, LEED Zero Energy and Fitwel certifications. Construction at the site is underway, and the project is expected to deliver in 2023, when Moderna anticipates beginning a phased move-in process. The location at 325 Binney Street enables Moderna to expand in proximity to its manufacturing center in Norwood, Massachusetts, also owned and operated by Alexandria.

08:35 EDT Bridgeline's Hawksearch launches updated integration for Salesforce - Bridgeline Digital announced that their Hawksearch software launched an updated 'Lightning-Ready' integration for Salesforce B2B Commerce Cloud on Salesforce AppExchange. The exclusive new connector empowers customers to increase conversions through advanced search, personalization, recommendations, and navigation. As the newest addition to Bridgeline software portfolio, Hawksearch is developing fully dedicated resources to their expansive partner network. The committed resources are able quickly identify and support new growth opportunities for customers of Salesforce.

08:33 EDT Sanofi announces results from Phase 2a study of amlitelimab - Results from a Phase 2a study evaluating the safety and efficacy of amlitelimab, a human monoclonal antibody targeting key immune system regulator OX40-Ligand, were presented as a late-breaker today at the European Academy of Dermatology and Venerology 2021 Virtual Congress. In the study, amlitelimab showed significant improvements in signs and symptoms of moderate-to-severe atopic dermatitis with a well-tolerated safety profile in adults whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach. In this Phase 2a double-blind, placebo-controlled study, participants were randomized to either intravenous amlitelimab-low dose, intravenous amlitelimab-high dose or placebo and were treated every four weeks over a 12-week period. Eligible patients included adults with moderate-to-severe atopic dermatitis whose disease is inadequately controlled with topical therapies such as corticosteroids, or where such therapies were not advisable. Co-primary endpoints included percent change in EASI from baseline, and incidence of treatment-emergent adverse events, at week 16. At week 16, the data demonstrated that when dosed every four weeks: Patients treated with amlitelimab-LD showed 80% improvement in average EASI from baseline, and patients treated with amlitelimab-HD showed 70% improvement in average EASI from baseline, compared to 49% for the placebo group. The difference between amlitelimab-LD and placebo was nominally statistically significant. The onset of response versus placebo was seen as early as Week 2 for both amlitelimab groups. No meaningful difference in responses was seen for the amlitelimab-LD and amlitelimab-HD groups. The overall rate of TEAEs was 35% for amlitelimab-LD, 17% for amlitelimab-HD and 31% for placebo. One serious adverse event was reported in the amlitelimab-LD group deemed related by the investigator at week 16; the event was resolved, and the patient was able to complete the study. No hypersensitivity reactions were reported. Also, at 16 weeks, key secondary endpoint data included: 44% of patients treated with amlitelimab-LD and 37% of patients treated with amlitelimab-HD achieved a score of 0 or 1 on the validated Investigator's Global Assessment scale compared with 8% with placebo. The vIGA is a 5-point scale ranging from 0 to 4 that measures the overall severity of skin lesions. 59% of amlitelimab-LD and 52% of amlitelimab-HD patients achieved 75% or greater skin improvement compared to 25% with placebo. 33% of amlitelimab-LD and 30% of amlitelimab-HD patients achieved 90% or greater skin improvement compared to 13% with placebo. A 60% improvement in the amlitelimab-LD group and a 59% improvement in the amlitelimab-HD group compared with 37% improvement in the placebo group in mean percent change from baseline in SCORing Atopic Dermatitis, a combined measure of area and severity of atopic dermatitis on the skin as well as patient-reported symptoms of itch and sleeplessness. At Week 36, 68% of patients who achieved a vIGA score of 0 or 1 at Week 16 maintained their response - 24 weeks after their last dose. Amlitelimab is a fully human non-depleting monoclonal antibody that binds to OX40-Ligand, a key immune regulator, and has the potential to be a first-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis. By targeting OX40-Ligand, amlitelimab aims to restore immune homeostasis between pro-inflammatory and anti-inflammatory T cells. Amlitelimab is being studied in patients with moderate-to-severe atopic dermatitis with suboptimal response to topical therapies. The potential for long-lasting treatment responses in atopic dermatitis patients may help reduce the burden of frequent dosing, and further investigation will be conducted in a future Phase 2b study. Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority

08:24 EDT SentinelOne, Blackpanda and Pandamatics team on incidence response for APAC - SentinelOn announced a strategic partnership with Blackpanda, Asia's premier digital forensics and incident response firm, and Pandamatics Underwriting, an Asia-focused cyber insurance coverholder. The partnership delivers a single source cyber resilience solution, providing customers with protection against advanced threats. "We've brought a comprehensive cyber resilience offering to market with the goal of providing Asian businesses with complete protection against sophisticated threats," said Gene Yu, CEO, Blackpanda. "The best way to provide incident response services following a breach is to deploy EDR technology that delivers autonomous detection and response capabilities. SentinelOne provides us with this, even as the attack surface has significantly expanded with the shift to work from home and cloud environments." "Blackpanda's unique offering in conjunction with SentinelOne detects threats early to mitigate risk," said Barnaby Page, Senior Director of Business Development, SentinelOne. "Deploying SentinelOne has proven to be an essential first step in incident response cases. The level of autonomy that our Storyline Active Response technology provides accelerates detection time and delivers unrivaled breach recovery."

08:19 EDT Bed Bath & Beyond CEO: Q2 a 'disruptive moment' amid multiyear transformation - Comments taken from Q2 earnings conference call.

08:17 EDT AstraZeneca Covid-19 vaccine shows 74.0% overall estimated efficacy in trial - The New England Journal of Medicine published a paper on the Phase 3 safety and efficacy of AZD1222, the Covid-19 vaccine developed by AstraZeneca and the University of Oxford, in a large, diverse population at increased risk for severe acute respiratory syndrome coronavirus 2, or SARS-CoV-2, infection in the United States, Chile, and Peru. A total of 32,451 participants in the United States, Chile, and Peru underwent randomization, in a 2:1 ratio, to receive AZD1222 or placebo. "Overall estimated vaccine efficacy was 74.0% and estimated vaccine efficacy was 83.5% in participants 65 years of age or older. High vaccine efficacy was consistent across a range of demographic subgroups. In the fully vaccinated analysis subgroup, no severe or critical symptomatic Covid-19 cases were observed among the 17,662 participants in the AZD1222 group; 8 cases were noted among the 8550 participants in the placebo group. The estimated vaccine efficacy for preventing SARS-CoV-2 infection - nucleocapsid antibody seroconversion - was 64.3%. SARS-CoV-2 spike protein binding and neutralizing antibodies increased after the first dose and increased further when measured 28 days after the second dose," the paper stated. Reference Link

08:13 EDT Aspira, Black Women's Health Imperative lead congressional briefing - Aspira Women's Health together with the Black Women's Health Imperative participated in a Congressional Briefing on September 27, 2021 to discuss the gaps in ovarian health diagnostics and treatments as well as solutions to successfully address them. Immediate and innovative actions regarding education, research investment, detection, and insurance coverage were highlighted, in addition to the dire consequences of racial and ethnic disparities and inequities endemic to this malignancy. Leadership at Aspira was able to drive awareness for our proprietary ovarian cancer risk assessment, OVA1plus for women with pelvic masses, as well as stress the need for streamlining the process for payor coverage and highlight the superior performance of OVA1plus in Black women. Ovarian cancer remains one of the most lethal gynecological cancers, despite decades of research. Ovarian cancer is the only gender-specific cancer with a greater than 50% mortality rate; every day approximately 60 women are diagnosted with ovarian cancer and there are an estimated 235,000 women living with ovarian cancer in the United States each year. The briefing was well-attended by more than 350 guests including many members of Congress and received significant media attention.

08:12 EDT BioDelivery Sciences to host ELYXYB Investor Day - BioDelivery Sciences International announced it will host a virtual ELYXYB Investor Day on Thursday, October 14, 2021, at 10:30am ET. The webinar will feature insights from migraine key opinion leaders including a presentation by Richard B. Lipton, M.D., Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine, Director of the Montefiore Headache Center, and internationally noted authority on migraine. Dr. Lipton will discuss the current treatment landscape, the unmet medical needs in treating patients with acute migraine, and the role ELYXYB may play as a treatment option for those patients. ELYXYB is the first and only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. The BDSI management team will also provide an update that will include an overview of the migraine market and details on ELYXYB.

08:11 EDT Spero Therapeutics enters into non-dilutive revenue interest financing agreement - Spero Therapeutics announced that it has entered into a revenue interest financing agreement with HealthCare Royalty Partners for up to $125M. Spero intends to use the proceeds from the agreement and existing cash on hand to prepare for the anticipated launch of tebipenem HBr, as well as to support the continued clinical development of SPR720 and SPR206. Under the terms of the agreement, Spero will receive $50 million from HealthCare Royalty Partners by October 21, 2021. Spero is also entitled to receive an additional $50 million upon the U.S. Food and Drug Administration approval of tebipenem HBr for a complicated urinary tract infection indication, and an additional $25 million upon the attainment of a prespecified commercial milestone and mutual agreement between Spero and HealthCare Royalty Partners. In exchange for the total investment amount received by Spero, HealthCare Royalty Partners will receive a tiered royalty on applicable revenue generated by tebipenem HBr, SPR720 and SPR206 and other products marketed by Spero until the aggregate amount paid to HealthCare Royalty Partners is two and a half times the total investment amount funded. The tiered royalty will begin in the low double digits and decrease to the low single digits upon the achievement of certain annual revenue thresholds. Applicable revenue includes net sales made by Spero worldwide and any payments received by the Company from its licensees on net sales outside the United States. Based on its current projections, and assuming approval of Tebi in 2022, Spero believes that the $50 million in upfront proceeds from the revenue interest financing and the $50 million approval milestone payment will extend its cash runway into 2H 2023, without accounting for the addition of a potential milestone payment.

08:10 EDT Aemetis signs offtake agreement with Delta for 250M gallons of SAF - Aemetis (AMTX) announced that an offtake agreement has been signed with Delta Air Lines (DAL) for 250M gallons of blended fuel containing sustainable aviation fuel, or SAF, to be delivered over the 10 year term of the agreement. The aggregate value of the agreement is estimated to be more than $1B, including LCFS, RFS, 45Q and tax credits. Delta's agreement with Aemetis builds on Delta's current effort for a future of net zero aviation, which includes committing to airline carbon-neutrality from March 2020 onward, aspiring to replace 10 percent of its conventional jet fuel consumption with sustainable aviation fuel by the end of 2030 and committing to set science-based targets aligned with the Paris Agreement. The sustainable aviation fuel is expected to be produced by the Aemetis renewable jet/diesel plant under development on a 125 acre former U.S. Army Ammunition production plant site in Riverbank, California. The blended sustainable aviation fuel is expected to be available for use by Delta starting in 2024.

08:08 EDT Amazon continues Las Vegas investment with delivery station - Amazon has officially launched its newest delivery station in Las Vegas at 650 E Owens Ave, North Las Vegas. The new 147,000 square foot delivery station has created hundreds of new jobs locally and is the third delivery station in the Las Vegas Valley. Amazon's Operations pay an average starting wage of $18 per hour with benefits starting on day one. This delivery station allows Amazon to continue to better serve customers in Las Vegas while being able to support our local community with quality career opportunities," said Daryl Desimone, Amazon Site Lead. "It's important that we are a positive addition to the neighborhood and are fully integrated into the communities in which we operate." This is the first Amazon operations site in the state to commission a local artist to create a mural on its exterior walls. Jerry Misko, one of Las Vegas' most prolific muralists, is a Las Vegas born artist with a unique talent of translating the famous neon lights of The Strip into paintings and murals. His mural, "Aurora," is a combination of abstract neon colors, desert flora, fossil fauna depictions, desert animals, and geometric elements.

08:07 EDT G-III Apparel, Inter Parfums enter licensing agreement for fragrance products - G-III Apparel (GIII) and Inter Parfums (IPAR) announced that they have entered into a long-term global licensing agreement for the creation, development and distribution of fragrances and fragrance-related products under the Donna Karan and DKNY brands. Inter Parfums will take on the exclusive license, effective July 1, 2022.

08:06 EDT CNS Pharmaceuticals doses first patient with Berubicin - CNS Pharmaceuticals announced the dosing of the first patients in its Berubicin clinical development program for the treatment of recurrent glioblastoma multiforme, one of the most aggressive types of brain cancer. Further patient enrollment, randomization and dosing is currently underway as well as a robust lineup of clinical sites located globally which are advancing toward activation and enrollment. A pre-planned, non-binding futility analysis will be performed after approximately 30%-50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

08:05 EDT OncoCyte publishes study on DetermaIO test in TNBC - Oncocyte announced the publication of peer-reviewed data showing the strong predictive ability of its 27-gene DetermaIO test in predicting immunotherapy responses in high-risk early-stage triple negative breast cancer, ot TNBC. The article titled "A Novel Immunomodulatory 27-Gene Signature to Predict Response to Neoadjuvant Immunochemotherapy for Primary Triple-Negative Breast Cancer", was published in the journal Cancers. Oncocyte's DetermaIO is a precision diagnostic test used to determine the likelihood of a patient response to immunotherapy and is the only multivariate diagnostic test that has shown prediction of immune therapy response in multiple tumor types using the same test and threshold. Existing studies support DetermaIO's utility in advanced lung, renal and bladder cancers. This newly published validation study of DetermaIO in TNBC, was a partnership with researchers from MD Anderson, Yale University, and Baylor University who collected baseline core needle biopsy samples from 55 patients with stage I-III primary TNBC who were enrolled in a neoadjuvant clinical trial assessing the effectiveness of IMFINZI combined with chemotherapy. The researchers found that DetermaIO was significantly associated with response to treatment and superior to PD-L1 immunohistochemistry, the standard biomarker employed for informing use of immune checkpoint inhibitors. Interestingly, the researchers explored a combination of PD-L1 IHC and DetermaIO and found potential utility in the combined use of these markers to most accurately identify responders. These results address an unmet need for a biomarker that can identify patients with TNBC who are most likely to respond to immunotherapy, and conversely those who are less likely to benefit and may choose to avoid the significant side effects that can affect long term survivors.

08:04 EDT Leidos awarded contract by U.S. Customs and Border Protection - Leidos was awarded a new prime contract by U.S. Customs and Border Protection to provide Low-Energy Portal systems for non-intrusive inspection of passenger vehicles at U.S.-Mexico land border crossings. The multiple-award LEP indefinite delivery/indefinite quantity contract has a total ceiling value of $390M. Under this award, Leidos has received an initial delivery order with a value of $107M, including options. The LEP systems will be integrated in Vista, California, and deployed to existing vehicle inspection sites across the U.S. southern border with Mexico. The LEP contract is a companion to the Multi-Energy Portal program awarded to Leidos in April 2021. CBP also recently awarded Leidos a second delivery order with a value of $95M, including options, under this existing MEP multiple-award indefinite delivery/indefinite contract. It has a total ceiling value of $480M.

08:03 EDT AppHarvest completes 'Summer Refresh', replanting at Morehead farm - AppHarvest announced it completed the "Summer Refresh" and replanting of its flagship high-tech indoor farm in Morehead, Ky. in preparation for the second season of harvesting. The more than 700,000 tomato plants in the 2.8 million sq. ft. facility are expected to reach a mature height of about 40 feet and begin producing within a couple of months after planting. Thus, the company continues to expect tomato net sales to be modest in the third quarter, approximately $300,000 to $400,000, with ramp-up in the fourth quarter as the planted acreage becomes fully productive. AppHarvest currently is operating one 60-acre high-tech indoor farm in Morehead, Ky., which is estimated to be able to produce about 40 million pounds of tomatoes per year, serving some of the top national grocery store chains and food service outlets. The company has more farms under construction in Eastern Kentucky that are expected to produce vine crops, berries and leafy greens. The Berea, Ky. 15-acre leafy green facility and Richmond, Ky. 60-acre tomato facility are each approximately 50 percent complete and are expected to be operational by the end of 2022. AppHarvest also announced that it has entered a $25 million cash-backed credit facility with JP Morgan based on its third high-tech, 30-acre indoor farm under construction that plans to grow berries in Somerset, Ky., which broke ground in June 2021. Proceeds from the 364-day credit facility, which is priced at LIBOR plus 225 basis points, will be applied toward capital expenditures and improvements, including construction of the company's fourth high-tech indoor farm.

08:02 EDT Nikola, OPAL Fuels sign MoU to develop hydrogen fueling stations - Nikola and OPAL Fuels have entered into a Memorandum of Understanding on the development, construction, and operation of hydrogen fueling stations in North America and the use of renewable natural gas in hydrogen production. Under this strategic engagement, Nikola and OPAL Fuels intend to co-develop and co-market hydrogen refueling infrastructure to accelerate the adoption of heavy-duty zero-emission fuel-cell electric vehicles. Under their Memorandum of Understanding, Nikola and OPAL Fuels intend to initiate beta projects with select customers to drive engagement and accelerate development. The Parties intend to also develop best-practices and standards for hydrogen refueling station design and protocols allowing for a more safe, reliable, scalable, and low total cost of ownership for the transportation market.

08:01 EDT SmileDirectClub partners with comedian Heather McMahan - SmileDirectClub is launching a social media kindness chain, prompting followers to inspire smiles by sharing random acts of kindness during World Smile Week, from October 1st through 8th. SmileDirectClub will be partnering with comedian Heather McMahan to kick-off this social media kindness chain, which will reward selected participants with our award-winning smile care products and free aligner treatment.

07:55 EDT Bed Bath & Beyond sees Q3 adjusted gross margin 34%-35% - Sees Q3 adjusted EBITDA $80M-$85M. Sees Q3 interest expense approximately $16M, tax rate 26%-28%. Comments taken from Q2 earnings conference call presentation slides.

07:53 EDT Arch Therapeutics appoints Larry Hicks to board of directors - Arch Therapeutics announced the appointment of Larry Hicks to its Board of Directors. Hicks is currently the CEO of Healthcare Components Group, a global manufacturer of OEM and replacement parts used for the manufacture and repair of medical devices.

07:50 EDT Bed Bath & Beyond CEO says 'results this quarter were below expectations' - Mark Tritton, Bed Bath & Beyond's President and CEO said, "While our results this quarter were below expectations, we remain confident in our multi-year transformation. Following solid growth in June, we saw unexpected, external disruptive forces towards the end of the quarter that impacted our outcome. In August, the final and largest month of our second fiscal period, traffic slowed significantly and, therefore, sales did not materialize as we had anticipated. As COVID-19 fears re-emerged amid the on-going Delta variant, we experienced a challenging environment. This was particularly evident in large, key states such as Florida, Texas and California, which represent a substantial portion of our sales. Furthermore, unprecedented supply chain challenges have been impacting the industry pervasively, and we saw steeper cost inflation escalating by month, especially later in the quarter, beyond the significant increases that we had already anticipated. This outpaced our plans to offset these headwinds. These factors impacted sales and gross margin." Tritton added, "Encouragingly, we've continued to make progress against the fundamentals of our three-year transformation strategy. Our buybuy BABY banner continued to build on its positive momentum from the past several quarters, growing double digits due to strength in apparel and travel gear and increasing market share for the period. We also celebrated the July re-opening of our Bed Bath & Beyond banner's NYC flagship store in Chelsea as part of our comprehensive store remodel program, which is exceeding our expectations. Our higher margin Owned Brands are outperforming our penetration goals across the overall chain, and even stronger in remodeled stores. As a group, we continued to leverage our enhanced digital channel, with significant growth above 2019 at nearly double the proportion of sales. Operationally, we entered the next phase of our supply chain modernization through our partnership with Ryder which is instrumental to our strategy. We are committed to executing over the short, mid and long term, especially during these early stages of our multi-year plan." "Our financial foundation is strong. We generated positive operating cash flow during the quarter. Our cash balance, coupled with our recently amended asset-based revolving credit facility, provides us on-going capital and liquidity strength of $2.0 billion. We are well positioned to continue our planned investments in our business and pave the way towards a more profitable future. We have the plan, the team and the resources to unlock our potential."

07:47 EDT Dole up 7.7% in pre-market at $17.07 per share - Shares of Dole are up 7.7% at $17.07 in pre-market trading following yesterday's 5.5% advance. The stock is seeing momentum on the WallStreetBets Reddit thread in terms of message volume this morning with a top-10 position over the past 24 hours.

07:46 EDT Lexagene Holdings reports on recent veterinary trade shows - LexaGene Holdings provided an update on the three veterinary conferences attended by the Company in September. During the month of September, the Company exhibited at the WVC Annual Conference, the International Veterinary Emergency and Critical Care Conference, and the Southwest Veterinary Symposium. Dr. Jack Regan, LexaGene's CEO and Founder stated, "At these shows, we believe that we had one of the busiest booths due to the uniqueness of our technology. We are happy to report that during these shows and through our digital marketing campaign, we have generated more than 750 leads during the month of September and have added to our number of sales. The sheer number of booth visitors and the excitement they showed over our technology has hardened our stance that in-clinic PCR testing will soon become common place in veterinary medicine. These shows marked the first time LexaGene demonstrated - in person - the usability and features of our MiQLab System. Universally, visitors showed excitement over the availability of our system that automates PCR testing for pathogen identification and anti-microbial resistance detection. Visitors at our booths included practice managers, veterinarians, veterinary technicians, and corporate decision makers. Our sales reps are actively following up with these individuals and are optimistic about closing many additional sales from these conferences. As most visitors first learned of LexaGene and our product at these shows, we need to allow sufficient time for closing the many opportunities that these shows provided us."

07:40 EDT Minim joins Telecom Infra Project Open Converged Wireless Project Group - Minim announced it joined the Telecom Infra Project Open Converged Wireless Project Group and will be supporting the Open Source TIP OpenWiFi Project. Minim and TIP OpenWiFi members are evaluating the use of Minim's intelligent connectivity software as a standard element in the Project Group's OpenWiFi framework. This move would allow ISPs and OEMs to activate Minim or any other Wi-Fi management software that supports OpenWiFi's new subscriber management framework on TIP OpenWiFi compliant devices.

07:39 EDT Insulet presnts Omnipod 5 trial extension phase results - Insulet has presented trial extension phase results for the Omnipod 5 Automated Insulin Delivery System. Omnipod 5 improved time in range and reduced HbA1c in children, adolescents, and adults, aged 6-70 years, with type 1 diabetes over a period of 12 months. The data was presented at EASD 2021, the annual meeting of the European Association for the Study of Diabetes. Insulet also presented new clinical outcomes data for people with type 1 diabetes using the Omnipod DASH System for 90 days, as well as overall positive self-management behaviors among individuals using Omnipod DASH, Continuous Glucose Monitoring, or CGM, and a cloud-based diabetes data management system. Following completion of the 3-month pivotal trial, the results of which were previously shared, 95% of study participants chose to continue use of Omnipod 5 in an ongoing extension study. Insulet presented its data in two groups of extension study participants with type 1 diabetes: 114 adults and adolescents between 14 and 70 years old, and 110 children aged 6 to 13.9 years. The participants used Omnipod 5 at home for a period of 12 months after a 14-day period using their standard therapy, which included both pump therapy and multiple daily injections. The results were presented in three-month intervals: months 1-3, months 4-6, months 7-9, and months 10-12. After 3 months of system use, adults and adolescents had a decrease in HbA1c from 7.2% to 6.8%. This decrease was maintained after a total of 12 months of use, with mean HbA1c remaining at 6.8%. Time in range increased from 63.6% to 73.8% in the first 3 months of use, and persisted at 72.7% in months 10-12 of use, corresponding to an additional 2.3 hours in target range. Median time less than70 mg/dL decreased from 2.1% to 1.1% after 3 months of use and remained at 1.1% in months 10-12 of use. Children had a decrease in HbA1c from 7.7% to 7.0% after 3 months of system use. This decrease was maintained after a total of 12 months of system use, with mean HbA1c remaining at 7.0%. TIR increased from 52.4% to 67.9% in the first 3 months of use, and persisted at 66.8% in months 10-12 of use, corresponding to an additional 3.5 hours per day in target range. Median time less than70 mg/dL remained low at 1.5% in the first 3 months of use and 1.4% in months 10-12 of use. The company expects to launch Omnipod 5 in limited release in the U.S. late in the fourth quarter 2021. The device is currently not CE marked or available in Europe. Insulet also presented two studies of people living with type 1 diabetes using Omnipod DASH. The first study evaluated glycemic improvement after 90 days of use in 4,738 individuals ranging in age from under 2 to over 65 years. The study was divided into two groups: children and adolescents under 18 years of age and adults 18 years or older. Overall, there was a significant decrease in HbA1c of -0.9% and a reduction in self-reported hypoglycemic events from 2.9 episodes to 1.3 episodes per week in adults and from 2.8 to 1.5 in children and adolescents. These patient-reported outcomes provide positive evidence that the use of Omnipod DASH was associated with significant reductions in HbA1c and hypoglycemic events after the initial 90 days of use for children, adolescents, and adults living with type 1 diabetes. The second presentation covered the first real-world study of 2,586 people living with type 1 diabetes on Omnipod DASH with CGM and cloud-based data management. Participants included Omnipod DASH users with at least 90 days of insulin pump data in a cloud-based data management system between July 2018 and August 2021, as well as a minimum of 14 days of CGM readings over a 3-month period. The study resulted in positive glycemic outcomes, with mean estimated HbA1c ranging from 7.2 to 7.7%, and a low percentage of time in hypoglycemia across all age groups. Overall, the mean TIR was 59.6%, with median 1.3% of time below 70mg/dL and 0.2% of time below 54 mg/dL. These real-world data demonstrate positive self-management behaviors among a large cohort of Omnipod DASH users, ranging from young children to older adults.

07:37 EDT Adaptive Biotechnologies launches closeSEQ assay reports - Adaptive Biotechnologies announced the launch of an enhanced version of its clonoSEQ B-cell Clonality report, which will now feature the immunoglobulin heavy chain - V mutation status for patients with chronic lymphocytic leukemia, or CLL. clonoSEQ is the first and only in vitro diagnostic cleared by the U.S. Food and Drug Administration to detect and monitor minimal residual disease in blood or bone marrow from patients with CLL. All clonoSEQ B-cell Clonality reports will automatically include IGHV mutation status. IGHV mutation status has been shown to be prognostic of outcomes in CLL, with mutated IGHV genes inferring better outcomes. Adding this feature to the clonoSEQ Assay will enable physicians to assess both IGHV status and MRD status with just one assay. Performing clonality assessment at time of diagnosis is an important step to establish patient-specific sequences to track for subsequent MRD monitoring, and studies have demonstrated that trackable sequences can be found in more than 95% of CLL patients. MRD describes the small number of cancer cells that remain in the body during and after treatment. MRD assessment with clonoSEQ is performed as a series of tests throughout a patient's cancer journey to evaluate prognosis, determine response to treatment, monitor disease during remission and detect potential relapse. Evidence generated in CLL clinical trials have shown that even the smallest amounts of residual disease can predict a patient's long-term clinical outcomes.

07:35 EDT Eve & Co appoints Jeannette VanderMarel to board of directors - Eve & Co announces that Jeannette VanderMarel has joined the Board of Directors of Eve & Co. An early entrepreneur in the cannabis industry, Jeannette VanderMarel was the Co-Founder and President of Good & Green, a cannabis company committed to setting a new standard for product quality and reliability as well as corporate social responsibility. VanderMarel replaces Yasir Naqvi on the Board of Directors who has resigned as a result of his election as a Member of Parliament for Ottawa Centre in the recent federal election.

07:35 EDT Arrowhead begins Phase 2b study of ARO-APOC3 for mixed dyslipidemia treatment - Arrowhead Pharmaceuticals announced that it has dosed the first patient in AROAPOC3-2002, a Phase 2b clinical study of ARO-APOC3 in adults with mixed dyslipidemia. ARO-APOC3 is the company's investigational RNA interference therapeutic being developed as a treatment for patients with severe hypertriglyceridemia mixed dyslipidemia, and familial chylomicronemia syndrome . Arrowhead intends to initiate a Phase 3 study of ARO-APOC3 in patients with FCS in the fourth quarter of 2021. Javier San Martin, M.D., chief medical officer at Arrowhead, said: "AROAPOC3-2002 is the second of three clinical trials that we plan to initiate this year to study investigational ARO-APOC3 in various patient populations, each with a unique lipid profile. The '2001 study, which we initiated in June of 2021, is enrolling patients with severe hypertriglyceridemia. The '2002 study is enrolling patients with mixed dyslipidemia, defined by moderately elevated triglycerides and elevated non-high-density lipoprotein cholesterol or elevated low-density lipoprotein cholesterol at screening. The planned '3001 study, which is on track to begin in the fourth quarter of 2021, will be a Phase 3 study in patients with genetically defined FCS. We look forward to continued progress for the clinical program and, if successful, providing new potential treatment options for patients with various levels of hypertriglyceridemia."

07:33 EDT InMed Pharmaceuticals commences Phase 2 trial of cannabinol - InMed Pharmaceuticals announced that it has commenced its Phase 2 clinical trial of INM-755 cream in the treatment of Epidermolysis Bullosa. This marks the first time cannabinol has advanced to a Phase 2 Clinical trial to be studied as a therapeutic option to treat a disease. This study will be taking place at eleven sites across seven countries including Austria, Germany, Greece, France, Italy, Israel and Serbia. Clinical Trial Applications have been filed in all participating countries with regulatory authority and ethics committee approvals currently in place in four countries. The first site initiation visit was completed at a clinical site in Austria, where screening for eligible patients will begin shortly. INM-755 is a cannabinol cream intended as a topical therapy to treat EB and potentially other dermatological diseases. Preclinical data demonstrate that INM-755 cream may help relieve hallmark EB symptoms, such as inflammation and pain, as well potentially restore the integrity of the skin in a subset of EB Simplex patients. Phase 1 data in healthy volunteers demonstrated INM-755 cream to be well-tolerated on both normal, intact skin as well as on open wounds and caused no delay in wound healing. The 755-201-EB study is designed to enroll up to 20 patients, conservatively within 12 months. All four subtypes of inherited EB, being EB Simplex, Dystrophic EB, Junctional EB, and Kindler Syndrome, are eligible for this study in which InMed will evaluate the safety of INM-755cream and its preliminary efficacy in treating symptoms and healing wounds over a 28-day period. The study will use a within-patient, double-blind design whereby matched index areas will be randomized to INM-755 cream or vehicle cream as a control.

07:32 EDT OptimizeRx appoints Edward Stelmakh as CFO, COO - OptimizeRx announced the appointment of Edward Stelmakh as chief financial officer, or CFO, and chief operating officer, COO, effective October 11th, 2021. He succeeds Doug Baker within the financial organization, who will continue as executive vice president of finance and accounting. Stelmakh is an accomplished senior executive with over 30 years of experience leading multiple areas of finance and operations across a variety of geographies and areas in the pharmaceutical industry.

07:26 EDT Bombardier announces firm order for 20 Challenger 3500 business jets - Bombardier announced a firm order for 20 Challenger 3500 business jets to a customer who wishes to remain confidential. This is Bombardier's largest business jet transaction of 2021, representing a value of $534M, based on current list pricing. The Challenger 3500 business jet is expected to enter service in the second half of 2022.

07:14 EDT CarMax drops 7% to $136.00 after Q2 earnings miss estimates

07:11 EDT Xebec Adsorption announces on-site hydrogen contact with flat steel manufacturer - Xebec Adsorption announced that it has signed a contract to supply two Hy.GEN 150 units with a Turkey-based flat steel manufacturer. The two units will have a capacity of approximately 600 kg of hydrogen per day at 99.999% purity to create a protective atmosphere within the annealing heat-treatment process. This contract from a flat steel producer represents the first of its kind received by Xebec and the third site in Turkey.

07:10 EDT Synairgen appoints Theodora Harold to board of directors - Synairgen is pleased to announce the appointment of Theodora Harold as an independent Non-Executive Director of the Company and Chair of the Audit Committee with immediate effect. Theodora has over 20 years' experience in the biotech sector and is currently CEO of Crescendo Biologics. Theodora is also a Chartered Accountant having qualified at PricewaterhouseCoopers.

07:10 EDT Nurix Therapeutics expands board of directors with two additional appointments - Nurix Therapeutics (NRIX) announced the appointments of Judith Reinsdorf and Paul Silva to its board of directors, effective October 1, 2021. Reinsdorf is the former executive vice president and general counsel of Johnson Controls (JCI), and Silva is the former senior vice president, chief accounting officer at Vertex Pharmaceuticals (VRTX).

07:07 EDT View's Smart Windows chosen by Ah Haa School for new facility - View announced its Smart Windows have been installed throughout the new home for the Ah Haa School for the Arts, a newly constructed community art and event center in Telluride, Colorado. "Multiple studies have shown that students thrive in environments with abundant natural light and outdoor views. View Smart Windows, which use artificial intelligence to automatically adjust in response to the sun, are designed to solve exactly this problem," the company said. Smart windows maximize the amount of natural light while minimizing heat and glare.

07:05 EDT Sutro Biopharma and Merck extend cytokine derivative research program - Sutro Biopharma (STRO) announced that Merck (MRK) has extended the research term for the first cytokine derivative program under the 2018 Merck Agreement, for an additional two years. The research extension is intended to facilitate completion of preclinical research and development activities for a second candidate, which has a novel design and approach. As part of this extension, Sutro is eligible to receive up to $10M. Under the terms of the 2018 Merck collaboration agreement, Sutro and Merck are conducting preclinical research and development of cytokine derivatives utilizing Sutro's proprietary cell-free protein synthesis and site-specific conjugation platforms, XpressCF and Xpress CF+. Merck has exclusive worldwide rights to therapeutic candidates derived from the collaboration. Additionally, research on a second cytokine derivative program on a separate target is ongoing.

07:04 EDT CynergisTek selected for $300,000 cybersecurity contract - CynergisTek has been selected for a new contract by one of the largest U.S. based federal credit unions valued at nearly $300,000 to provide Red Team and Security Assessment services.

07:03 EDT Trevena announces results from TRV027 study in COVID-19 patients - Trevena announced data from 30 patients enrolled in the proof-of-concept study of TRV027, the Company's novel AT1 receptor selective agonist, in hospitalized COVID-19 patients. The results showed that TRV027 was well-tolerated and provided initial evidence of its potential to improve biomarker and clinical endpoints associated with COVID-19 disease severity and progression. "I am pleased to announce the results from this analysis, which provide initial evidence of the therapeutic potential of TRV027 to improve COVID-19 patient outcomes. With the ACTIV and REMAP-CAP COVID-19 platform trials currently evaluating TRV027, and data expected as early as mid-2022, we look forward to building upon these promising results," said Carrie Bourdow, President and CEO of Trevena. The primary endpoint was mean change from baseline D-dimer levels at three days. D-dimer is a biomarker used to monitor the risk of abnormal clotting throughout the vascular system. In patients with COVID-19, elevations in circulating D-dimer are also known to be an accurate predictor of critical disease progression and death. Among TRV027 treated patients, 70% experienced a reduction in circulating D-dimer, compared to of patients on placebo. TRV027 was associated with a 92% probability of a potential beneficial treatment effect, based on a Bayesian model analysis recommended by the study's Data Monitoring and Safety Committee, or DSMC. Notably, a post-hoc analysis indicated that patients receiving TRV027 experienced a 12 day reduction in average length of hospital stay compared to placebo, with a median reduction of 4 days.

06:53 EDT CarMax plans to open total of 10 new locations in FY22 - Opened three new locations in Q2.

06:51 EDT CarMax sold 419,895 units in Q2 - Sold 419,895 units through retail and wholesale channels combined, up 19.9% from the prior year quarter, primarily driven by strong demand for used autos and solid execution supported by the omni-channel experience. Retail used unit sales increased 6.7% to a second quarter record of 231,797 vehicles and comparable store unit sales increased 6.2% compared with the same quarter a year ago. Wholesale units increased 41.4% to 188,098 vehicles from the prior year second quarter, an all-time high quarterly record.

06:49 EDT Reata Pharmaceuticals plans NDA submission for omaveloxolone in 1Q22 - Reata Pharmaceuticals announced that it has completed its pre-New Drug Application meeting with the United States FDA for omaveloxolone for the treatment of patients with Friedreich's ataxia and reaffirmed its plan to submit an NDA in the first quarter of 2022. The company stated, "The purpose of the pre-NDA meeting was to discuss the content of Reata's planned NDA submission. We plan to submit the NDA seeking standard approval for omaveloxolone for the treatment of Friedrich's ataxia. We are not planning to conduct a second pre-approval clinical study prior to the submission. The FDA indicated that the appropriate approval pathway would be a matter of review after submission of the NDA. In response to our questions about the contents of the filing and because of the seriousness of the indication, the FDA exercised its discretion subject to review to permit us to submit the results of certain nonclinical and clinical studies after approval."

06:48 EDT Pfizer's Cibinqo approved in Japan for atopic dermatitis - Pfizer-s Cibinqo - abrocitinib -, an oral, once-daily, JAK1 inhibitor, has been approved by the Japanese Ministry of Health, Labour and Welfare, or MHLW, for the treatment of moderate to severe atopic dermatitis in adults and adolescents aged 12 years and older with inadequate response to existing therapies. The approval of Cibinqo in Japan was based on the results from 1,513 patients across four Phase 3 studies, ranging from 12 to 16 weeks of treatment, and a long-term extension study from a robust clinical trial program. Regulatory applications for abrocitinib have been submitted to countries around the world for review, including the U.S., Australia, and the European Union. The UK Medicines and Healthcare products Regulatory Agency granted Great Britain marketing authorization for Cibinqo earlier this month.

06:47 EDT Merck to acquire Acceleron for $180 per share in cash, or $11.5B - Merck (MRK) and Acceleron Pharma (XLRN) announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Acceleron for $180 per share in cash for an approximate total equity value of $11.5B. Under the terms of the acquisition agreement, Merck, through a subsidiary, will initiate a tender offer to acquire all outstanding shares of Acceleron. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Acceleron's outstanding shares, receipt of applicable regulatory approvals, and other customary conditions. Upon the successful completion of the tender offer, Merck's acquisition subsidiary will be merged into Acceleron, and any remaining shares of common stock of Acceleron will be canceled and converted into the right to receive the same $180 per share price payable in the tender offer. The transaction is expected to close in the fourth quarter of 2021.

06:45 EDT Merck to acquire Acceleron for $180 per share in cash

06:43 EDT Immunic enrolls first patient in CALLIPER trial - Immunic announced enrollment of the first patient in its phase 2 CALLIPER trial of lead asset IMU-838, the company's selective oral DHODH inhibitor, in patients with progressive multiple sclerosis, or PMS. The trial, which is intended to run concurrently with and as a complement to the company's twin phase 3 ENSURE trials in relapsing-remitting multiple sclerosis is focused on progressive forms of multiple sclerosis and designed to corroborate IMU-838's neuroprotective potential in this patient population.

06:33 EDT Babcock & Wilcox's Renewable segment awarded $38M for waste-to-energy solution - Babcock & Wilcox's B&W Renewable segment has received an award for more than $38M to supply waste-to-energy technologies for municipal waste projects in East Asia. B&W Renewable will design, manufacture and supply its Volund DynaGrate combustion grates and provide technical site services, in addition to designs for the plants' fuel-feeding and ash-removal equipment. B&W also will supply a waste-to-energy boiler under a technology license. The facilities will be capable of processing approximately 2 million tons of municipal waste annually.

06:22 EDT Google's YouTube bans all anti-vaccination content - YouTube announced Wednesday that it will ban all content that claims approved vaccines do not work or are harmful, not just misinformation about COVID-19 shots. YouTube said in a blog post: "We've long removed content that promotes harmful remedies, such as saying drinking turpentine can cure diseases. At the onset of COVID-19, we built on these policies when the pandemic hit, and worked with experts to develop 10 new policies around COVID-19 and medical misinformation. Since last year, we've removed over 130,000 videos for violating our COVID-19 vaccine policies... We've steadily seen false claims about the coronavirus vaccines spill over into misinformation about vaccines in general, and we're now at a point where it's more important than ever to expand the work we started with COVID-19 to other vaccines. Specifically, content that falsely alleges that approved vaccines are dangerous and cause chronic health effects, claims that vaccines do not reduce transmission or contraction of disease, or contains misinformation on the substances contained in vaccines will be removed. This would include content that falsely says that approved vaccines cause autism, cancer or infertility, or that substances in vaccines can track those who receive them. Our policies not only cover specific routine immunizations like for measles or Hepatitis B, but also apply to general statements about vaccines." Reference Link

06:12 EDT AIM ImmunoTech signs clinical trial agreement for Phase 2a Ampligen trial - AIM ImmunoTech and hVIVO have a signed Clinical Trial Agreement for a Phase 2a Human Challenge Trial to test the company's drug Ampligen as a potential intranasal prophylactic using a human rhinovirus - HRV-16, a common cold virus - and influenza A virus - H3N2 -. This antiviral study will be conducted by hVIVO, a subsidiary of Open Orphan, a specialist pharmaceutical services clinical research organization in vaccine and antiviral testing using human challenge clinical trials. The AIM-sponsored study is expected to start in Q4. The proposed protocol for the study has been submitted to the Oxford Research Ethics Committee/Medicines and Healthcare Regulatory Agency and its response is expected by mid November. Preparations to commence the study are now underway, pending the expected approval. A successful Phase 2a study could also establish Ampligen as a potential prophylaxis against future viral variants and future novel respiratory viruses for which there are no current therapies, as well as mutations of known viruses such as SARS-CoV-2, which causes COVID-19. Further, exploratory endpoints are designed to develop data related to Ampligen's potential ability to confer enhanced and expanded immunity post-infection.

06:07 EDT SEC charges former Goldman Sachs compliance analyst with insider trading - The Securities and Exchange Commission on Wednesday charged Jose Luis Casero Sanchez, a Spanish national and former Senior Compliance Analyst who worked in the Warsaw, Poland office of an international investment bank, with insider trading in advance of at least 45 corporate events involving the investment bank's clients. The SEC has obtained an emergency court order to freeze Sanchez's assets, including certain accounts he used to place the illicit trades. According to the SEC's complaint, filed in the United States District Court for the Southern District of New York, Sanchez had broad access to highly sensitive information regarding mergers and other transactions in which his firm was involved, in connection with his work as a compliance analyst. Sanchez had access to this information so that he could assist the firm's efforts to ensure that employees kept the information confidential and did not engage in insider trading. However, between September 2020 and May 2021, Sanchez allegedly abused that position of trust by trading on at least 45 events involving the investment bank's clients based on the investment bank's material, nonpublic information. The complaint alleges that Sanchez generated more than $471,000 in ill-gotten gains during the course of the scheme. The Fly notes that Sanchez worked for Goldman Sachs. Reference Link

06:04 EDT Diginex shareholders vote to change name to Eqonex - Diginex announced that its shareholders voted in favor of changing its corporate name to Eqonex. The company's Nasdaq ticker, EQOS will remain. The change in name was approved by shareholders at the company's first annual general meeting.

06:02 EDT Eli Lilly, Incyte present detailed BRAVE-AA1 and BRAVE-AA2 trial results at EADV - Eli Lilly (LLY) and Incyte (INCY) announced detailed results from two pivotal Phase 3 trials, BRAVE-AA1 and BRAVE-AA2, which found once-daily Olumiant 4-mg was superior to placebo in achieving significant scalp hair regrowth as early as 24 weeks in adults with severe alopecia areata, or AA, as defined by 50% scalp hair loss at baseline. Significant improvements in scalp hair regrowth compared to placebo were achieved at 36 weeks for patients taking OLUMIANT 2-mg and 4-mg oral doses, as previously disclosed in topline findings from BRAVE-AA1 and BRAVE-AA2 earlier this year. In both studies, a greater proportion of patients taking OLUMIANT 4-mg compared to placebo also achieved full regrowth or regrowth with minimal gaps in coverage of eyebrow and eyelash hair at 36 weeks, which were key secondary endpoints of the studies. These results, along with safety data in adult patients with moderate to severe atopic dermatitis, or AD, are being presented virtually at the 30th European Academy of Dermatology and Venerology, or EADV, Congress, taking place from September 29-October 2.

05:37 EDT JetBlue announces new, nonstop service between New York and London - JetBlue announced it has expanded its presence in the transatlantic market with new, nonstop service between New York's John F. Kennedy International Airport, or JFK, and London Gatwick Airport, or LGW. The first customer-carrying JetBlue flight from the U.S. touched down at Gatwick just before 8 o'clock this morning, local time. The flights - which operate four times weekly in October, then daily onward from November - arrive well timed for the long-awaited easing of U.S. entry requirements for travelers from the U.K. and other European destinations.

05:29 EDT JinkoSolar provides update on proposed IPO in China - JinkoSolar provided updates on the status of the proposed initial public offering and listing of the shares of its principal operating subsidiary, Jinko Solar on the Shanghai Stock Exchange's Sci-Tech innovation board. During the 75th review meeting of 2021, the stock listing committee of the STAR Market reviewed Jiangxi Jinko's application and considered that Jiangxi Jinko had met the offering, listing and disclosure requirements related to its proposed STAR Market IPO. As a next step, Jiangxi Jinko will need to go through the registration process with the China Securities Regulatory Commission before Jiangxi Jinko's STAR Market IPO can take place.

05:24 EDT Regeneron announces REGEN-COV trial meets primary endpoint - Regeneron announced that a trial assessing investigational REGEN-COV in patients hospitalized with COVID-19 met its primary endpoint. Trial results will be presented at IDWeek 2021 and show that REGEN-COV significantly reduced viral load in patients hospitalized with COVID-19 who entered the trial without having mounted their own antibody response (seronegative) and required low-flow or no supplemental oxygen. The trial also had clinical results supportive of the much larger UK RECOVERY trial in hospitalized patients, with numeric improvements observed across all clinical endpoints assessed. The trial, which was stopped due to slow enrollment after recruiting just over one third the patients originally planned, found that patients who received REGEN-COV in addition to standard-of-care, or SOC, experienced numeric improvements across all clinical endpoints assessed, compared to SOC alone. Researchers did not observe any clinical difference between the two REGEN-COV doses or any serious or dose-dependent safety signals in REGEN-COV treated patients. In a safety analysis involving 2,007 patients serious adverse events occurred in 21% REGEN-COV patients and 26% placebo patients. Infusion-related reactions and hypersensitivity reactions that were grade 2 occurred more commonly among REGEN-COV patients than placebo patients. The trial originally assessed a broader group of patients; however in late 2020 the trial was adjusted to exclude patients who were on mechanical ventilation or high-flow oxygen at baseline based on a potential safety signal identified by an Independent Data Monitoring Committee in 199 patients on mechanical ventilation or high flow-oxygen, a finding that was not replicated in the much larger RECOVERY trial that enrolled hospitalized patients with a broad range of severe COVID-19, including these patient groups.

05:15 EDT Takeda Pharmaceutical, JCR Pharmaceuticals announce JR-141 license agreement - Takeda Pharmaceutical and JCR Pharmaceuticals announced a geographically-focused exclusive collaboration and license agreement to commercialize JR-141, an investigational, next-generation recombinant fusion protein of an antibody against the human transferrin receptor and iduronate-2-sulfatase, or IDS, enzyme for the treatment of Hunter syndrome. Hunter syndrome is caused by a deficiency of IDS and manifests in different forms. JR-141, applied with J-Brain Cargo, JCR's proprietary blood-brain barrier, or BBB, technology, is engineered to transport the therapeutic enzyme across the BBB to directly reach the brain and address both the somatic and neuronopathic manifestations of the disease, which can lead to progressive cognitive decline. Under the terms of the exclusive collaboration and license agreement, Takeda will exclusively commercialize JR-141 outside of the United States, including Canada, Europe, and other regions. JCR will receive an upfront payment for such ex-U.S. license, and is eligible to receive additional development and commercial milestones as well as tiered royalties on potential sales. The two companies will collaborate to bring this therapy to patients as quickly as possible upon completion of the global Phase 3 program, which will be conducted by JCR. Takeda receives an option under a separate option agreement, which allows Takeda to acquire an exclusive license to commercialize JR-141 in the U.S. upon completion of the Phase 3 program.

05:07 EDT Paysafe announces partnership with Fubo Gaming - Paysafe (PSFE) announced a partnership with Fubo Gaming, the Chicago-based subsidiary of FuboTV (FUBO). Expected to launch in Q4 subject to obtaining requisite regulatory approvals, Fubo Gaming's mobile sportsbook, Fubo Sportsbook, will plug into Paysafe for credit and debit card payments, the Skrill USA digital wallet, and paysafecard and Paysafecash eCash solutions.