Stockwinners Market Radar for September 20, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:28 EDT Ball Corp. enters into alliance with Boomerang Water - Ball Corp "announced an alliance to bring consumers a sustainable way to stay hydrated. At resorts, cruise ships, campuses and elsewhere, Ball will provide its aluminum bottles for the Boomerang Bottling System, a cutting edge technology that offers the convenience of bottled water in a sustainable package while limiting the environmental impact. Boomerang's Bottling System washes, rinses, filters, fills and caps fresh water in refillable, returnable and recyclable Ball aluminum bottles, therefore eliminating the waste and carbon emissions produced by manufacturing and transporting traditional, disposable bottles."

20:06 EDT Cathie Wood's ARK Investment bought 316.2K shares of CareDx today

18:35 EDT Nvidia CEO: Market for gaming is fundamentally strong - In an interview on CNBC's Mad Money, Jensen Huang said the gaming market is solid and vibrant. It has grown 70% in two years. The company is working on normalizing inventory in the channel, he noted. Huang cited a strong pipeline of products in development. "It has been a little tough, but we're coming back," he added.

17:50 EDT Southern Missouri Bancorp, Citizens Bancshares agree to merge - Southern Missouri Bancorp, the parent corporation of Southern Bank, and Citizens Bancshares Co., the parent company of Citizens Bank and Trust Company, announced the signing of a definitive merger agreement whereby Southern Missouri will acquire Citizens in a stock and cash transaction. Citizens operates 14 banking centers throughout greater Kansas City, St. Joseph and Northwest Missouri. At June 30, 2022, Citizens' consolidated assets were $1.0 billion, including net loans of $465 million, while deposits totaled $879 million. Southern Missouri reported total assets at June 30, 2022, of $3.2 billion, including net loans of $2.7 billion, and total deposits of $2.8 billion. On a pro forma basis, following the acquisition, the combined company's total assets will approximate $4.5 billion, with net loans of $3.3 billion, and total deposits of $3.8 billion. The combined company will operate 65 locations in Missouri, Arkansas, Illinois, and Kansas. Under the terms of the merger agreement, unanimously approved by the boards of both entities, Citizens' shareholders will have the right to elect either a fixed exchange ratio of 1.1448 shares of Southern Missouri common stock or a cash payment of $53.50 for each Citizens' share, subject to adjustment based on Citizens' capital and the total outstanding shares of Citizens at closing. Based on Southern Missouri's average closing stock price of $52.53 over the 20-day trading period ended September 19, 2022, the aggregate transaction value is approximately $140 million. The deal value equates to 150% of Citizens' tangible capital at June 30, 2022, represents a 5.9% premium to core deposits, and is a multiple of 7.1 times Citizens' projected forward earnings including fully phased-in cost savings, which are estimated at 35%. Excluding certain one-time merger charges, including Southern Missouri's additional provision for credit losses as required under ASU 2016-13 ("CECL''), the transaction is anticipated to be accretive to earnings per share by approximately 5% in our fiscal year ended June 30, 2023, and by 17% in our fiscal year ended June 30, 2024. Tangible book value per common share is expected to be diluted by approximately 8% at closing, with a projected earnback period of less than 2.75 years, based on the crossover method. Southern Missouri and Citizens anticipate completion of the transaction early in the first calendar quarter of 2023, subject to satisfaction of customary closing conditions, including regulatory and shareholder approvals for both parties.

17:37 EDT Equity Bancshares approves 1M shares repurchase program - The Equity Bancshares Board of Directors authorized the repurchase of up to 1,000,000 shares of Equity's outstanding common stock, par value 1c per share, from time to time, beginning October 1, 2022, and concluding September 30, 2023. The repurchase program does not obligate Equity to acquire a specific dollar amount or number of shares, and it may be extended, modified or discontinued at any time without notice. Non-objection from the Federal Reserve Bank of Kansas City related to this repurchase plan was received September 16.

17:23 EDT Stitch Fix says consumer discretionary spend pulled back from apparel - Says June and July were particularly challenging. Says setting the stage for profitable growth in 2024. Says recognizes challenges of current macro environment. Says July was especially challenging. Says consumer discretionary spend pulled back from apparel. Says expects lower inventory levels in back half of 2023. Says will likely maintain level of spend in FY23. Comments taken from Q4 earnings conference call.

17:03 EDT Granite announces two projects near Houston, Texas worth around $107M - Granite announced that is has been awarded two construction contracts worth approximately $107M on State Highway 288 near Houston, Texas. When combined with the previously announced $40M contract on a different segment of SH 288, the additional segments give Granite more than $145M of work on SH 288. The contracts were awarded and will be funded by the Texas Department of Transportation. They are anticipated to be included in Granite's third quarter CAP. In total, the two projects-one centered on SH 288 at Cedar Rapids Parkway, the other on SH 288 at Dubuque Parkway-cover 24 lane miles in six miles of four lane highway. The scope of work includes construction of five new bridges, the reconstruction and reconfiguration of entry and exit ramps approaching the new structures, and new grade separations. Granite will set up a batch concrete plant to provide material for these projects.

17:02 EDT North Mountain Merger to redeem public shares, will not complete combination - North Mountain Merger Corp. announced that it will redeem all of its outstanding shares of Class A common stock, par value $0.0001, effective as of the close of business on September 30, because North Mountain will not consummate an initial business combination within the time period required by its Amended and Restated Certificate of Incorporation. The per-share redemption price for the public shares will be approximately $10.00. As of the close of business on September 30, 2022, the public shares will be deemed cancelled and will represent only the right to receive the Redemption Amount. There will be no redemption rights or liquidating distributions with respect to the company's warrants, which will expire worthless. The company's sponsor has waived its redemption rights with respect to the outstanding founder shares and private placement shares. After September 30, 2022, the company shall cease all operations except for those required to wind up the company's business.

16:52 EDT Google debuts search tools for eco-friendly hotels, flights and train tickets - "According to recent research, people want to make sustainable choices when they travel, but they often lack the information needed to do so. To help solve this problem, we've embedded sustainability into our travel tools over the past year. For example, you can see estimated carbon emissions on Google Flights, and when you search for hotels, you'll find an eco-label on properties that carry a certification from a trusted third-party group. Today, we're introducing even more tools to help you make greener choices when you travel. With new filters for both flights and hotels, it's easier to find more sustainable options. If you want to view only flights that have lower emissions compared to the average for similar trips, simply tap the "Low Emissions" filter on Google Flights," said Richard Holden VP of Travel Products gor Google. Reference Link

16:40 EDT Schlumberger, Aramco team on digital sustainability solutions for abatement - Schlumberger and Aramco have announced plans to collaborate and develop a digital platform that will provide sustainability solutions for hard-to-abate industrial sectors. The proposed platform will enable companies in industries such as oil and gas, chemicals, utilities, cement and steel to collect, measure, report and verify their emissions, while also evaluating different decarbonization pathways. "Aramco and Schlumberger are hoping to draw on our long history of collaboration and partnership to deliver a digital sustainability ecosystem that enables global organizations to manage their carbon emissions and realize ambitious sustainability goals," said Olivier Le Peuch, chief executive officer, Schlumberger. "The sustainability platform will be a game changer for the energy and hard-to-abate industry sectors as they look toward a lower-carbon future." "This collaboration represents an unprecedented opportunity for both companies to leverage digitalization to tackle one of the most critical challenges of our generation. At the same time, it would expand digital capabilities within the Kingdom of Saudi Arabia and harness Schlumberger's global reach to potentially deliver a worldwide impact," said Ahmad A. Al-Sa'adi, senior vice president of Technical Services at Aramco.

16:34 EDT Destination XL CMO Ujjwal Dhoot to depart, James Reath to succeed - Destination XL (DXLG) announced that James Reath will join its team as chief marketing officer, or CMO, on September 26. Reath brings over 20 years of marketing leadership experience with a particular focus on omni-retail, digital marketing, brand building and consumer insights. Prior to joining DXL, Reath served as SVP, Marketing, Bed Bath & Beyond (BBBY). At DXL he will be responsible for the marketing organization, including the overall marketing strategy, brand, consumer, creative, media, CRM and digital commerce. Reath will replace Ujjwal Dhoot, the company's current chief marketing officer, who has informed the company that he will be leaving the company effective October 11.

16:33 EDT Vaccitech promotes Gemma Brown to CFO - Vaccitech announced the promotion of Gemma Brown as Chief Financial Officer . Gemma Brown succeeds Georgy Egorov. "Gemma has been highly engaged with all financial activities at Vaccitech including working with our auditors, corporate budgeting, SEC financial filings and other activities so we anticipate a seamless transition," said Bill Enright, Chief Executive Officer of Vaccitech. "I want to personally thank Georgy for his contributions to Vaccitech particularly his efforts that led to our successful IPO in 2021. We wish him the best in his future endeavors."

16:32 EDT International Game unit signs 15-year contract with OLG - International Game Technology announced that its subsidiary, IGT Global Solutions, was chosen by the Ontario Lottery and Gaming Corporation following a competitive procurement as the primary technology provider of self-serve lottery terminals. This agreement marks the first time that self-serve technology is expected to be available to lottery players in Ontario. The contract will run until June 2027 and includes 10 additional one-year contract extension options. Subject to further government approvals, terminals will begin to be installed in retail locations in the second half of 2023.

16:24 EDT Beyond Meat says COO Doug Ramsey suspended, effective immediately - Beyond Meat issued the following statement: "Doug Ramsey, Beyond Meat's Chief Operating Officer, has been suspended effective immediately. Operations activities will be overseen on an interim basis by Jonathan Nelson, Senior Vice President, Manufacturing Operations."

16:22 EDT Schmitt Industries receives not in compliance letter from NASDAQ - On September 14 Schmitt Industries received written notice from the Listing Qualifications Department of The Nasdaq Stock Market notifying the Company that it did not file its Annual Report on Form 10-K for the fiscal year ended May 31 by September 13 as required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5250. Under Nasdaq rules, the Company has 60 calendar days, or until November 13, to submit to Nasdaq a plan to regain compliance with Nasdaq rules. If Nasdaq accepts the plan, the Company will have until February 27, 2023 to regain compliance. The Company is working to finalize the Form 10-K and intends to file the Form 10-K in October to regain compliance. Schmitt's common stock will continue to be listed and traded on the Nasdaq Capital Market during the 60-day grace period, subject to its compliance with the other continued listing requirements of the Nasdaq Capital Market. Schmitt has determined that its financial statements as of and for the quarterly periods ended from August 31, 2021 through February 28, 2022 included in the associated Form 10-Qs for the periods ended August 31, 2021, November 30, 2021 and February 28, 2022, including the comparative periods, filed with the SEC, should no longer be relied upon due to certain errors in the ineffective application of cut-off procedures resulting primarily in the exclusion of certain general and administrative expenses from the statement of operations in the Company's financial statements during the fiscal year ended May 31 and will require restatement. The Company's preliminary estimate is that the cumulative effect of these errors is a misstatement of $330,203 in under-recognized expenses over the first three quarters of its fiscal year; however such amount is subject to revision as the Company finalizes its analysis.

16:21 EDT Massachusetts AG announces $12M settlement with Encore Capital - Massachusetts Attorney General Maura Healey announced a $12M settlement, including restitution and debt relief for Massachusetts consumers, with a national debt collection company and its subsidiaries for allegedly engaging in unfair and deceptive debt buying and collection in violation of state laws and the AG's Debt Collection Regulations. The assurance of discontinuance, filed in Suffolk Superior Court, with Encore Capital Group, Inc., and its subsidiaries, Atlantic Credit and Finance, Inc., Midland Funding, LLC., and Midland Credit Management, Inc., alleges that the companies were collecting on debts without sufficient proof that the debts were valid and accurate, using misleading collection tactics to obtain payments from consumers experiencing financial hardship, making repeated and harassing debt collection calls, failing to prevent its collection law firm from using falsified information about the existence of lawsuits and judgments, and attempting to collect debts that were beyond the statute of limitations, the AG's office said. Reference Link

16:18 EDT Aurora Cannabis reaffirms $150M-$170M in annualized cost savings by Dec 31 - Reiterates adjusted EBITDA profitability run rate by December 31, 2022.

16:16 EDT Farmer Bros. gets notice from JCP Investment of intention to nominate directors - Farmer Bros. confirmed receipt of notice from JCP Investment Partnership and its affiliates of its intent to nominate three individuals to stand for election to the company's board of directors at the company's annual meeting of stockholders. The board will review JCP Partnership's proposed nominees and present its recommendations in the company's definitive proxy statement, which will be filed with the U.S. Securities and Exchange Commission and mailed to all stockholders eligible to vote at the 2022 annual meeting. The company's stockholders are not required to take any action at this time.

16:12 EDT ClearPoint Neuro announces Mazin Sabra to join as COO - ClearPoint Neuro announced that Mazin Sabra will join the Company effective October 10th as Chief Operating Officer. Mr. Sabra will report directly to Joe Burnett, ClearPoint Neuro's Chief Executive Officer, and serve as a member of the Company's senior leadership team.

16:11 EDT Cidara says FDA accepts NDA for priority review for rezafungin treat candidemia - Cidara Therapeutics announced that the U.S. Food and Drug Administration has accepted for filing and granted Priority Review to its New Drug Application for rezafungin for the treatment of candidemia and invasive candidiasis. The FDA has assigned a Prescription Drug User Fee Act target action date of March 22, 2023 enabled by rezafungin's designation as a Qualified Infectious Disease Product and has indicated that it is currently planning to hold an advisory committee meeting to discuss the application. QIDP designation is reserved for antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections. Rezafungin is a novel, once-weekly echinocandin antifungal being developed for the treatment of candidemia and invasive candidiasis, as well as for the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplant. "Today's announcement is an important step forward for patients fighting difficult-to-treat and often deadly candidemia and invasive candidiasis, and represents a critical milestone for Cidara's rezafungin development program," said Jeff Stein, President, and CEO of Cidara Therapeutics. "The data generated across our Phase 2 and Phase 3 trials demonstrated that rezafungin could transform the current standard of care for the treatment of invasive Candida infections, and we are excited that rezafungin could potentially be the first new drug approved for this indication in over a decade." The NDA submission for rezafungin was supported by positive clinical data from the global ReSTORE Phase 3 and STRIVE Phase 2 clinical trials. Rezafungin dosed once-weekly demonstrated statistical non-inferiority versus caspofungin, the current standard of care, dosed once-daily, meeting the primary endpoints for both the FDA and the European Medicines Agency .

16:06 EDT VeriSign closes Q2 with 351.5M domain name registrations - The company states: "VeriSign announced that the second quarter of 2022 closed with 351.5 million domain name registrations across all top-level domains, an increase of 1.0 million domain name registrations, or 0.3%, compared to the first quarter of 2022.1,2 Domain name registrations have increased by 10.4 million, or 3.0%, year over year. The .com and .net TLDs had a combined total of 174.3 million domain name registrations in the domain name base3 at the end of the second quarter of 2022, a decrease of 0.4 million domain name registrations, or 0.2%, compared to the first quarter of 2022. The .com and .net TLDs had a combined increase of 3.7 million domain name registrations, or 2.2%, year over year. As of June 30, 2022, the .com domain name base totaled 161.1 million domain name registrations, and the .net domain name base totaled 13.2 million domain name registrations. New .com and .net domain name registrations totaled 10.1 million at the end of the second quarter of 2022, compared to 11.7 million domain name registrations at the end of the second quarter of 2021."

16:06 EDT Puma announces exclusive license agreement with Takeda - Puma Biotechnology (PBYI) announced an agreement with Takeda (TAK) to license the worldwide research and development and commercial rights to alisertib, a selective, small-molecule, orally administered inhibitor of aurora kinase A. Alisertib is an adenosine triphosphate-competitive and reversible inhibitor of aurora kinase A and results in disruption of mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on aurora kinase A. Alisertib has been tested in clinical trials in patients with metastatic cancers including breast cancer, small cell lung cancer, head and neck cancer, ovarian cancer, peripheral T cell lymphoma and acute myeloid leukemia. Under the terms of the agreement, Puma will assume sole responsibility for the global development and commercialization of alisertib. Takeda will receive an upfront license fee of $7 million and is eligible to receive potential future milestone payments of up to $287.3 million upon Puma's achievement of certain regulatory and commercial milestones over the course of the agreement, as well as tiered royalty payments for any net sales of alisertib.

16:04 EDT Capital Southwest raises dividend to 52c per share - Capital Southwest announced its Board of Directors has declared a quarterly dividend of 52c per share for the quarter ending December 31.

15:58 EDT Fennec Pharmaceuticals' PEDMARK approved by FDA - Fennec Pharmaceuticals' PEDMARK was approved by FDA to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors, according to an approval and prescribing information notice posted to the agency's website. Reference Link

15:33 EDT West Virginia AG announces opioid settlement with Walmart and CVS - West Virginia Attorney General Morrisey is giving an update on the opioid settlement in a livestreamed press conference. Reference Link

14:44 EDT Walmart Canada announces $1B in major infrastructure investments this year - Walmart Canada is investing $1B in infrastructure this year as part of the retailer's efforts to speed up and transform the business for its customers.A cornerstone of the investment includes more than $100M to build a new high-tech sortable fulfillment centre near Montreal in Vaudreuil-Dorion, Quebec - the first of its kind for Walmart in the province. The new facility, currently slated to open in 2024, will offer better product availability and quicker service for customers choosing to shop in-store or online at Walmart.ca. This year's $1B investment also includes plans to update and remodel a record number of stores in a year. Store changes include modernizing and upgrading physical spaces with a focus on improving the customer experience both in-store and online. These projects are all part of Walmart Canada's multi-year $3.5B investment to make the online and in-store shopping experience simpler, faster and more convenient for customers as the retailer invests for continued growth to help more Canadians save money and live better. Reference Link

13:59 EDT FDA says 'committed to strengthening U.S. infant formula supply' - Robert Califf, M.D., MACC, Commissioner of Food and Drugs - Food and Drug Administration, issued a statement that reads in part: "For the past several months, the U.S. Food and Drug Administration has been working around the clock with our U.S. government partners, including the U.S. Department of Health and Human Services and the U.S. Department of Agriculture, to expand consumer access to infant formula products, while also ensuring that these products meet the agency's safety, nutrition and quality standards. This has been no small undertaking. Years of consolidation in the infant formula industry and concerning food safety processes and general procedures at some of the facilities producing these products have resulted in a fragile supply chain that is susceptible to production disruptions when quality issues are identified... Earlier this year I asked Dr. Steven Solomon, director of the Center for Veterinary Medicine, to conduct a top-down review of agency activities and decision-making related to the shutdown of Abbott's Sturgis, Michigan, infant formula facility in February 2022. Today, Dr. Solomon released the results of the review in a 10-page report, which includes information gleaned from interviews with FDA staff directly involved in the agency's response to infant formula shortages as a result of the Sturgis facility closure. I agree with the findings and recommendations identified in the report, but it is important to note that I have also requested a broader and more comprehensive evaluation of the FDA's Foods Program... The situation at the Abbott Sturgis facility has highlighted just how little authority the FDA has to compel many companies to 'do the right thing' without intervention. While domestic infant formula manufacturers have stepped up to meet the call to increase their production capacity and are working diligently, the long-term resiliency of the infant formula supply chain will rely on greater diversification of manufacturers, including new entrants to the U.S. marketplace, investment in new manufacturing facilities by infant formula producers and a commitment by these companies to consistently and continuously adhere to the FDA's quality and safety standards. Ultimately, these combined approaches will protect the most vulnerable individuals." Reference Link

13:30 EDT Nvidia says company 'quite far ahead' in ray-tracing - Says everything in keynote was rendered in real time.

13:05 EDT Avangrid consolidates onshore and offshore renewables businesses - AVANGRID announced the consolidation of its onshore and offshore renewables businesses. Leading the consolidated business will be Jose Antonio Miranda, who will serve as President and CEO of Avangrid Renewables. "As we strive to maximize asset value, efficiently execute projects, and manage the changing dynamics of business in the U.S., consolidation of the onshore and offshore businesses will allow AVANGRID to leverage human capital, supply chain synergies, and project execution experience across Renewables," said Pedro Azagra, AVANGRID CEO. "With critical milestones for our offshore wind projects approaching, Miranda's key experience in the wind turbine industry, and his successful asset optimization of AVANGRID's onshore wind business, ensures we have strong consolidated leadership." Miranda was appointed Co-CEO and President of Onshore for Avangrid Renewables in October of 2021.

12:47 EDT Super Micro Computer expands Nvidia-certified server portfolio - Super Micro Computer (SMCI) announced a full line of new systems optimized for NVIDIA (NVDA) H100 Tensor Core GPUs, encompassing over 20 product options. With a large portfolio of NVIDIA-Certified Systems, Supermicro is now leveraging the new NVIDIA H100 PCI-E and NVIDIA H100 SXM GPUs, it said in a statement.

12:28 EDT Nvidia announces OVX computing systems powered by Ada Lovelace GPU - NVIDIA announced the second generation of NVIDIA OVX, powered by the NVIDIA Ada Lovelace GPU architecture and enhanced networking technology, to deliver real-time graphics, AI and digital twin simulation capabilities. The company said: "The new NVIDIA OVX systems are designed to build 3D virtual worlds using leading 3D software applications and to operate immersive digital twin simulations in NVIDIA Omniverse Enterprise - a scalable, end-to-end platform enabling enterprises to build and operate metaverse applications."

12:23 EDT Hoegh LNG Partners shareholders approve merger at special meeting - Hoegh LNG Partners LP announced that at a special meeting held today, the Partnership's common unitholders voted on and approved the Agreement and Plan of Merger, dated as of May 25, 2022, by and among Hoegh LNG Holdings Ltd., Hoegh LNG Merger Sub LLC, Hoegh LNG Partners LP and Hoegh LNG GP LLC, and the merger contemplated thereby. Pursuant to the Merger Agreement, Hoegh LNG has agreed to acquire all of the outstanding common units of the Partnership for $9.25 per unit in cash. The Merger is expected to close on or about September 23, 2022.

12:18 EDT Nvidia announces partnership with the Broad Institute of MIT, Harvard - NVIDIA announced a partnership with the Broad Institute of MIT and Harvard to provide the Terra cloud platform and its over 25,000 users with the AI and acceleration tools needed to quickly analyze massive amounts of healthcare data. The company said: "The collaboration is designed to connect NVIDIA's AI expertise and healthcare computing platforms with the Broad Institute's world-renowned researchers, scientists and open platforms with a focus on three key areas: Making NVIDIA Clara Parabricks available in the Terra platform; Building large language models; Bringing improved deep learning to Genome Analysis Toolkit."

12:02 EDT Hertz plans to order up to 175,000 EVs from GM over next five years

12:00 EDT General Motors, Hertz plan major EV expansion

12:00 EDT AMTD Digital falls -9.8% - AMTD Digital is down -9.8%, or -$9.00 to $83.00.

12:00 EDT Genco Shipping rises 7.4% - Genco Shipping is up 7.4%, or 97c to $14.09.

12:00 EDT Ampex Corp rises 89.5% - Ampex Corp is up 89.5%, or $5.28 to $11.18.

11:51 EDT Nvidia announces launch of new Jetson Orin Nano system-on-modules - Nvidia announced it has expanded the Jetson lineup with the launch of new Jetson Orin Nano system-on-modules, which the company said "deliver up to 80x the performance over the prior generation, setting a new standard for entry-level edge AI and robotics." The Orin Nano modules will be available in two versions. The Orin Nano 8GB delivers up to 40 TOPS with power configurable from 7W to 15W, while the 4GB version delivers up to 20 TOPS with power options as low as 5W to 10W. The Jetson Orin Nano modules will be available in January, starting at $199.

11:51 EDT iRobot, Amazon receive request for additional information from FTC - In a regulatory filing, iRobot (IRBT) disclosed that the company and Amazon (AMZN) each received a request for additional information and documentary materials from the FTC in connection with the FTC's review of the Merger. The Second Request is a next step in the regulatory review process. The effect of the Second Request is to extend the waiting period imposed by the HSR Act until 30 days after iRobot and Amazon have substantially complied with the Second Request, unless that period is extended voluntarily by the parties or terminated sooner by the FTC. Both parties expect to promptly respond to the Second Request and to continue to work cooperatively with the FTC in its review of the Merger. Completion of the Merger remains subject to the expiration or termination of the waiting period under the HSR Act and the satisfaction or waiver of the other closing conditions specified in the Merger Agreement.

11:44 EDT U.S. video game spending declined 5% year-over-year to $4.1B, says NPD - NPD analyst Mat Piscatella said that August 2022 consumer spending across video game hardware, content and accessories declined 5% when compared to a year ago, to $4.1B. This total is slightly higher than the $4.07B total reached during the August 2020 tracking period. Year-to-date spending through August 2022 totaled $34.6B, a 9% drop when compared to the same period in 2021, but 3% higher than the $33.5B achieved during the 2020 comparable period. 2022 video game monthly consumer spending has returned to 2020 levels, Piscatella noted. Video game hardware dollar sales grew 14% when compared to a year ago, to $375M, helped by improved supply of PlayStation 5 (SONY) and Xbox Series (MSFT) consoles. Year-to-date hardware spending declined by 4% to $2.9B. PlayStation 5 was August's best-selling hardware platform in both unit and dollar sales. The Nintendo Switch (NTDOY) has sold the highest number of units in 2022 thus far, while PlayStation 5 led the market in dollar sales. As was noted in July, both PlayStation 5 and Xbox Series again experienced double-digit percentage growth during the month when compared to a year ago. Other publicly traded companies in the video game space include Electronic Arts (EA), Activision Blizzard (ATVI), Take-Two (TTWO), Tencent (TCEHY), Ubisoft (UBSFY), GameStop (GME), Nvidia (NVDA), Roblox (RBLX), Bandai Namco (NCBDY), and Capcom (CCOEY). Reference Link

11:36 EDT Nvidia announces launch of Omniverse Cloud services - Nvidia announced what it calls its "first software- and infrastructure-as-a-service offering - NVIDIA Omniverse Cloud - a comprehensive suite of cloud services for artists, developers and enterprise teams to design, publish, operate and experience metaverse applications anywhere." "The metaverse, the 3D internet, connects virtual 3D worlds described in USD and viewed through a simulation engine. With Omniverse in the cloud, we can connect teams worldwide to design, build, and operate virtual worlds and digital twins," said Jensen Huang, founder and CEO of Nvidia. Omniverse Farm, Replicator and Isaac Sim containers are available today on NVIDIA NGC for self-service deployment on AWS using Amazon EC2 G5 instances featuring NVIDIA A10G Tensor Core GPUs. In addition, Omniverse Cloud will be available as NVIDIA managed services via early access by application, the company stated.

11:22 EDT Nvidia says GeForce RTX 40 Series 'delivers quantum leap in performance' - Nvidia has unveiled the GeForce RTX 40 Series of GPUs, which the company says are "designed to deliver revolutionary performance for gamers and creators, led by its new flagship, the RTX 4090 GPU, with up to 4x the performance of its predecessor." "The age of RTX ray tracing and neural rendering is in full steam, and our new Ada Lovelace architecture takes it to the next level. Ada provides a quantum leap for gamers and paves the way for creators of fully simulated worlds. With up to 4x the performance of the previous generation, Ada is setting a new standard for the industry," said Jensen Huang, Nvidia's founder and CEO, at the GeForce Beyond: Special Broadcast at GTC. "The RTX 4090 is the world's fastest gaming GPU with astonishing power, acoustics and temperature characteristics. In full ray-traced games, the RTX 4090 with DLSS 3 is up to 4x faster compared to last generation's RTX 3090 Ti with DLSS 2. It is also up to 2x faster in today's games while maintaining the same 450W power consumption. It features 76 billion transistors, 16,384 CUDA cores and 24GB of high-speed Micron GDDR6X memory, and consistently delivers over 100 frames per second at 4K-resolution gaming. The RTX 4090 will be available on Wednesday, Oct. 12, starting at $1,599. The company also announced the RTX 4080, launching in two configurations. The RTX 4080 16GB has 9,728 CUDA cores and 16GB of high-speed Micron GDDR6X memory, and with DLSS 3 is 2x as fast in today's games as the GeForce RTX 3080 Ti and more powerful than the GeForce RTX 3090 Ti at lower power. The RTX 4080 12GB has 7,680 CUDA cores and 12GB of Micron GDDR6X memory, and with DLSS 3 is faster than the RTX 3090 Ti, the previous-generation flagship GPU. Both RTX 4080 configurations will be available in November, with prices starting at $1,199 and $899, respectively," Nvidia stated.

11:22 EDT Tellurian sinks after canceling bond offering needed to fund project - Tellurian shares are falling after the company announced last night that, due to uncertain conditions in the high-yield market, it has withdrawn its proposed public offering of units consisting of 11.25% senior secured notes due 2027 and warrants to purchase shares of Tellurian common stock. Tellurian has struggled to attract financing for its liquefied gas complex in Lake Charles, Louisiana, which it began constructing prior to obtaining funding, Bloomberg reports. The canceled bond deal and warrants were intended to kickstart further financing on the first phase of the project known as Driftwood LNG, it adds. Shares of Tellurian are down 23% to $3.00 in morning trading.

11:18 EDT AMPX Stock trading halted, volatility trading pause

11:10 EDT Arcutis announces results from two Phase 3 roflumilast studies published in JAMA - Arcutis Biotherapeutics announced that the Journal of the American Medical Association, or JAMA, published "positive" results from two pivotal Phase 3 studies - DERMIS-1 and DERMIS-2 - evaluating roflumilast cream 0.3% as a once daily, topical treatment for chronic plaque psoriasis. The "Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS" One and Two, or DERMIS-1 and DERMIS-2, were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which roflumilast 0.3% cream or matching vehicle cream were applied once daily for eight weeks to subjects age 2 years and above with mild, moderate, or severe chronic plaque psoriasis involving between 2% and 20% body surface area. DERMIS-1 enrolled 439 subjects, and DERMIS-2 enrolled 442 subjects. In both studies, significantly more patients treated with roflumilast cream reached IGA Success at week eight compared to the control group of vehicle-treated patients. Patients with clinically significant itch, as measured by a baseline Worst Itch Numerical Rating Scale of greater than or equal to four, achieved a 4-point reduction in WI-NRS at week eight. Improvement in itch was observed by two weeks, the earliest timepoint measured, with consistent improvements achieved through week eight. "These data highlight the robust efficacy of ZORYVE as a novel non-steroidal treatment option for individuals with plaque psoriasis. Both studies met the primary endpoint of IGA success and demonstrated rapid clearance of plaques and reduction of itch. Coupled with ZORYVE's favorable safety and tolerability data, these results reinforce that ZORYVE can offer patients a single topical therapy for use on all psoriasis-affected areas - including hard to treat areas such as elbows and knees and intertriginous areas. We are thrilled that such a prestigious journal has published the results of our pivotal Phase 3 trials," said Patrick Burnett, M.D., Ph.D., Chief Medical Officer of Arcutis.

10:43 EDT NeuroBo Pharmaceuticals trading resumes

10:37 EDT Borqs subsidiary signs agreement to provide solar + energy systems in Hawaii - Borqs Technologies announced its solar energy storage subsidiary, Holu Hou Energy, has signed a power purchase agreement with Kapolei Diversified Properties to deliver energy to Luhauola, a new mixed-use development in Kapolei, on the island of Oahu, Hawaii. The property includes 10,000 square feet of commercial space, plus outdoor dining for local food establishments. The residential portion of the property includes 29 workforce housing rental apartments. The contract is valued at several million dollars and includes 200KW of PV and 500KWh of energy storage. The system will be placed into service in 2023. "In July of this year, HHE signed agreement with Honokea Villages to deliver a major renewable energy generation and storage system to Honokea's planned ecological sports training and Hawaiian Cultural facility in their "ahupua'a", or local community. The development will have Olympic calibre training facilities for surfing, sport climbing, kayaking, beach volleyball, and more, and will serve as tool to celebrate athletics in Hawaii. The renewable energy system will feature over 3 MW of PV generation and over 4 MWh of energy storage, enough to power 100% of the operations of the facility, and will be financed under a 20-year power purchase agreement, or PPA. The system provided by HHE will begin construction in 2023 and its value is estimated at nearly $20M. This project is included in the $49.8 million of Q2 2022 signed contracts announced earlier this month," stated Pat Chan, CEO of Borqs Technologies, "ESG is becoming increasingly imperative in this global energy crisis. Global warming and dependence on fossil fuel continue to affect the economy and people's everyday life. Our Holu Hou Energy subsidiary is on track to executing an exciting business plan to grow its market share in Hawaii, one of the states with the highest electricity prices in the U.S., and is actively in discussions with potential customers in California, which is expected to be more than 30 times bigger than the market in Hawaii merely based on residential electricity usage."

10:34 EDT TravelCenters sees $75M-$125M annual tuck-in acquisitions - Sees LT low to mid single digit fuel volume CAGR, with mid to high single digit truck service revenue CAGR and low to mid single digit hospitality revenue CAGR. Also sees LT mid single digit fuel gross margin plus non fuel revenue CAGR. Plans to maximize operating leverage through 100-150bps improvement in labor/site operating expense over the medium term. Sees mid single digit total gross margin CAGR over 3-5 years, with a target to improve blended CPG into the range of 17c-19c over the term. Comments taken from investor presentation slides.

10:25 EDT Uniper says Germany to obtain 'significant majority stake' - Uniper (UNPRF) said it is in final discussions with the German government and Fortum (FOJCY) regarding an amendment to the stabilization package of July 22. The amended stabilization package now inter alia provides for a capital increase in the amount of EUR 8B with exclusion of subscription rights, to be subscribed exclusively by the Federal Government, the company said in a statement. In addition, the German government is to acquire the Uniper shares currently held by Fortum. "As a result, it is envisaged that the Federal Government will obtain a significant majority stake in Uniper. The final agreement has not yet been concluded," Uniper added.

10:23 EDT Iron Mountain sees deploying about $4B in growth capex over 2023-2026 - Commenting on its capital allocation priorities in investor presentation slides, Iron Mountain said it is planning to deploy about $4B in growth-oriented capital over the next four years, or 2023-2026, which it said will "fully fund" its growth plan. The company is expecting to incur about $150M of one-time costs annually from 2023-2025 for transformation support, it added in the slides.

10:02 EDT SSAB partners with McNeilus, Oshkosh to build commercial vehicles in U.S. - McNeilus Truck and Manufacturing, Inc., an Oshkosh Corporation company, announced a partnership with SSAB in fossil-free steel applications for severe-duty commercial vehicles. SSAB initiated this partnership with Oshkosh Corporation because of its reputation as a leading innovator of mission-critical vehicles and essential equipment, including McNeilus' refuse collection vehicles, the company said in a statement. Oshkosh Corporation and McNeilus are working together on future research and development initiatives across multiple commercial vehicle product lines, it added.

10:01 EDT L3Harris Technologies awarded $91.5M contract from Boeing - L3Harris Technologies (LHX) won a $91.5M contract from Boeing (BA) to supply mission-management processors for the T-7A Red Hawk, the newest U.S. Air Force jet trainer in 60 years. The mission-management processors, developed specifically for the Red Hawk, collate multiple data streams, making the information a pilot has to process in-flight easier to decipher. The sensors and communication capabilities maximize battlespace awareness by connecting internal and external data networks and link video feeds to flight displays. The processors also host specific simulations for pilots undergoing training.

10:00 EDT Annovis Bio falls -7.2% - Annovis Bio is down -7.2%, or -$1.34 to $17.33.

10:00 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares rises 6.8% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is up 6.8%, or 97c to $15.21.

10:00 EDT Ampex Corp rises 8.8% - Ampex Corp is up 8.8%, or 52c to $6.42.

09:54 EDT Social Capital Hedosophia Holdings Corp. VI to close down with no deal - Social Capital Hedosophia Holdings Corp. VI announced that it would not complete its initial business combination by October 14, the deadline for the company to complete its initial business combination. Due to the company not completing a business combination by October 14, it will "as promptly as possible, but not more than ten business days thereafter," redeem 100% of its issued and outstanding class A ordinary shares. The redemption is expected to be completed on October 17. Based upon the amount held in the trust account as of June 30, the company estimates that the per share redemption Amount will be approximately $10.01. The company anticipates that the public shares will cease trading as of the close of business on October 14.

09:52 EDT BCAN Stock trading resumes

09:47 EDT Direxion Daily Jr Gld Mnrs Bull 3X Shrs falls -5.5% - Direxion Daily Jr Gld Mnrs Bull 3X Shrs is down -5.5%, or -$1.54 to $26.36.

09:47 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares rises 5.6% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is up 5.6%, or 80c to $15.04.

09:47 EDT Banco Bradesco rises 8.8% - Banco Bradesco is up 8.8%, or 27c to $3.35.

09:42 EDT Mullen places $92M stalking horse bid for Electric Last Mile Solutions - In a regulatory filing on Monday, Mullen Automotive (MULN) announced that on September 16, it entered into a "stalking horse" Asset Purchase Agreement with David W. Carickhoff, solely as Chapter 7 trustee of the Bankruptcy Estates of Electric Last Mile Solutions, Inc. (ELMS) and Electric Last Mile, Inc. In June 2022, the Debtors commenced bankruptcy proceedings by filing voluntary petitions for relief under the provisions of Chapter 7 of Title 11 of the United States Code in the United States Bankruptcy Court for the District of Delaware. Pursuant to the Agreement, the company agreed to purchase certain assets of the Debtors, including a plant in Mishawaka, Indiana and assumption of the related land contract, all inventory and tangible personal property, customer and supplier information, and certain intellectual property rights, out of the Chapter 7 Bankruptcy for approximately $55M plus the assumption of monetary liabilities related to assumed contracts, including the land contract, which are estimated to be approximately $37M. Pursuant to the Agreement, the closing will take place within 30 days after entry of the sale order of the Bankruptcy Court approving such sale pursuant to the Bankruptcy Code in a form reasonably acceptable to the company and the seller. The Company provided a deposit of $5.5 million, which will be applied towards the purchase price. The deposit will be retained by the Seller if the Agreement is terminated based on a material breach of the Agreement by the Company or returned to the Company if the Agreement is otherwise terminated. If the Seller closes on a competing transaction for the Assets, then, subject to any order of the Bankruptcy Court, the Company is entitled to a break-up fee in the amount of $1.65 million.

09:36 EDT Save Foods announces growing interest in Europe for eco-treatment - Save Foods announced growing interest among European retailers and distributors in Save Foods innovative eco-treatment. As regulators and retailers across Europe move toward a "zero-tolerance" policy regarding pesticide residue limits, a growing number of European retailers and distributors are pursuing pilots with Save Foods to fight waste of fresh produce all along the food supply chain.

09:32 EDT Wintermute loses $160M in DeFi hack - Wintermute founder and CEO Evgeny Gaevoy disclosed in a series of Tuesday tweets that the crypto market maker has lost roughly $160M in a hack. He said, "Short communication on the ongoing Wintermute hack...We've been hacked for about $160M in our defi operations. Cefi and OTC operations are not affected...We are solvent with twice over that amount in equity left...If you have a MM agreement with Wintermute, your funds are safe. There will be a disruption in our services today and potentially for next few days and will get back to normal after...Out of 90 assets that has been hacked only two have been for notional over $1 million (and none more than $2.5M), so there shouldn't be a major selloff of any sort. We will communicate with both affected teams asap...If you are a lender to Wintermute, again, we are solvent, but if you feel safer to recall the loan, we can absolutely do that." Publicly traded companies in the space include Bit Digital (BTBT), Coinbase (COIN), Core Scientific (CORZ), Greenidge Generation (GREE), Marathon Digital (MARA), MicroStrategy (MSTR), Riot Blockchain (RIOT), Stronghold Digital Mining (SDIG) and TeraWulf (WULF). Reference Link

09:29 EDT Intermediate, long-term Treasury Bond ETFs fall to 2022 lows - Ahead of tomorrow's FOMC decision, the iShares 7-10 Treasury Bond ETF (IEF) is down 0.5% at $97.70, below June lows, with U.S. 10-year Treasury Yield rising by 7bps to 3.56% - the highest level since 2011. iShares 20+ Year Treasury Bond ETF (TLT) is also down 1.5% at $105.72 and indicated to open at fresh 2022 lows.

09:23 EDT Corphousing acquires rights to 217 units in downtown Manhattan - CorpHousing announced it has acquired long-term rights for 217 units in downtown Manhattan in New York through a 15-year Master Lease Agreement, or MLA, with one of the largest privately held real estate investment companies in the world. The 217 units associated with this luxury hotel is the first step in the company's post IPO scaling strategy and increases units by 34% bringing CHG's total units under long-term lease to 853. CorpHousing plans to start operating this property during Q4 2022.

09:21 EDT Cuentas appoints Jay Adams as CEO of Cuentas Mobile - Cuentas announced that it has hired Jay Adams as the new CEO of Cuentas Mobile. Adams previously held executive positions at IDT Corporation and Kare Distribution, where he consistently grew annual revenue to more than $200 million.

09:20 EDT Optex Systems announces final results of tender offer - Optex Systems Holdings announced the final results of its "modified Dutch auction" tender offer to purchase up to $4.25 million in value of shares of its common stock, par value $0.001 per share which expired at 5:00 P.M., New York City time, on September 15, 2022. Based on the final count by Continental Stock Transfer & Trust Company, the depositary for the Offer, a total of 1,727,926 shares of Common Stock were properly tendered and not properly withdrawn at or below the purchase price of $2.65 per share. In accordance with the terms and conditions of the Offer, and based on the final count by the depositary, Optex accepted for purchase 1,603,774 shares of Common Stock at a price of $2.65 per share, for an aggregate cost of approximately $4.25 million, excluding fees and expenses relating to the Offer. These shares represent approximately 19.3% of its shares of Common Stock outstanding as of September 15, 2022. Based on these final numbers, immediately following settlement of the Offer, Optex will have approximately 6,716,637 shares of Common Stock outstanding. A director and an executive officer of the Company participated in the Offer. Because the Offer was oversubscribed, Optex accepted for payment only a pro-rated portion of the shares of Common Stock properly tendered by each tendering stockholder. Based on the final tender count, and taking into consideration the effect of odd lot priority on the pro-ration factor, the final pro-ration factor for the Offer was approximately 92.8% of the shares of Common Stock properly tendered at or below the purchase price of $2.65 per share. Payment for the shares of Common Stock accepted for purchase under the Offer will occur promptly, in accordance with applicable law.

09:16 EDT The Brick opens Commercial Design Centre in Richmond Hill - The Brick announced the opening of its new Commercial Design Centre in Richmond Hill, ON. Under the banner of The Brick Commercial Division / Midnorthern Appliance, the centre will serve builders, developers, designers and property managers, offering high-end premium and luxury appliances, hospitality restaurant equipment, commercial office furniture and more.

09:12 EDT Neovasc provides corporate update following clinical data release - Neovasc announced positive clinical data at the Transcatheter Cardiovascular Therapeutics Conference, CTC, held September 16-19 in Boston. Prof. Shmuel Banai, MD, Neovasc Medical Director and Head of Interventional Cardiology at the Tel Aviv Medical Center, Israel, presented new interim clinical data on the use of the Neovasc Reducer in patients who have angina with non-obstructive coronary artery disease, so-called "ANOCA" patients, most often caused by underlying microvascular disease. Prof. Banai presented interim data from the first 11 patients in a clinical trial in Israel aimed at evaluating the impact of the Reducer in patients with microvascular disease. The study aims to enroll 30 patients in total. 67% of patients enrolled in the study thus far are female. The interim results suggest improvements in objective measures of blood flow in the microvascular system of the heart. After invasive physiological assessment the following observations were made: Coronary microvascular flow parameters improved; Symptoms of angina improved; Functional capacity improved; Quality of Life improved. "This is intriguing early clinical data that could lead to Reducer being used as a treatment option for a patient population at least as large as our current target market and at a much earlier stage in the patient treatment cycle," commented Fred Colen, President and CEO of Neovasc. Neovasc Provides Update on Mitral Valve Program: After careful analysis and given the emerging opportunities for the Reducer in the ANOCA patient population, the Company has decided to put further development and the European CE-Marking regulatory approval process for the Tiara-TA on hold and focus the organization on Reducer therapy and the ongoing COSIRA-II clinical trial. Strategically, the Company believes this is the best use of its financial and workforce resources.

09:11 EDT AeroVironment awarded $20.87M in DoD contract awards - AeroVironment announced it received two firm-fixed-price U.S. Department of Defense Foreign Military Sales, or FMS, contract awards totaling $20.87M to provide Puma 3 AE small unmanned aircraft systems, initial spares packages, training and Contractor Logistics Support to two allied nations.

09:09 EDT Datasea completes delivery of smart hotel solution software - Datasea announced that Shuhai Zhangxun Information Technology, a subsidiary of the Chinese operating company contractually controlled by the Company, has completed the delivery of Smart Hotel Solution to a leading general contractor, China Mobile Construction Nanjing after having successfully passed the software system testing conducted by CMCNC. The delivery was made pursuant to an approximately $961,000 procurement agreement that entails the Smart Hotel Solution development, maintenance, and integration services. Commenting on today's announcement, Zhixin Liu, CEO of Datasea stated, "This project dovetails nicely with our focus on the smart city market where our differentiated products provide a design and production solution for performance and security. The agreement with CMCNC is reflective of the growing popularity of smart city services across the nation and the momentum we've witnessed in the adoption of the cloud-based IoT applications. With an anticipated upward trend in demand for smart city solutions, Datasea is able to help enterprises and citizens make informed, data-driven decisions to improve overall efficiency."

09:08 EDT Hoth Therapeutics partners with Altasciences to manufacture HT-TBI product - Hoth Therapeutics has signed an agreement with Altasciences, a fully integrated early phase CRO/CDMO, to develop and manufacture the HT-TBI drug product formulation. HT-TBI is being developed as a novel, point-of-care therapy for the treatment and/or prevention of secondary brain injury resulting from ischemic stroke and traumatic brain injury. HT-TBI will be developed as a ready-to-use drug-device combination product for use in non-healthcare settings by patients and caregivers at risk for stroke/TBI, emergency healthcare professionals, and military personnel. The HT-TBI formulation development and manufacturing work by Altasciences will be used to support a future Investigational New Drug Application to initiate clinical trials.

09:07 EDT Ibex continues expansion in Central America, hiring 500 employees in Nicaragua - ibex announced the continued growth of its operations in Nicaragua to support multiple new client accounts and is hiring 500 new employees at all levels located in its Invercasa and Ofiplaza sites. "ibex is excited to expand its operations in Nicaragua to deliver amazing customer experiences for its growing list of top companies," said Henry Bermudez, Vice President of Operations - Nicaragua, at ibex. "We are hiring 500 new employees ranging from customer service agents to management positions. Now is a great time to join the winning team at ibex."

09:06 EDT Walgreens Boots Alliance to acquire remaining 30% stake in Shields for $1.37B - Walgreens Boots Alliance announced the acceleration of its plans for full ownership of Shields Health Solutions , which is delivering strong financial performance, clinical excellence and value-add contributions to WBA's business. WBA has entered into a definitive agreement to acquire the remaining 30% stake, approximately 35% on a fully-diluted basis, for approximately $1.37B, which is based on the exit multiple agreed at the time of WBA's 2021 investment in Shields. "Our full acquisition of Shields will complete another major milestone as part of our consumer-centric healthcare strategy to drive sustainable long-term growth, and we are very pleased with our partnership and integration with Shields," said Roz Brewer, CEO, WBA. "We can now make further progress on our strategy through Shields' integrated model, increasing our value to health systems, expanding access to payor partners and supporting improved outcomes and lower costs." ...Shields will continue as a distinct business and brand within Walgreens. John Lucey, co-founder and current president of Shields, will lead the organization as CEO of Shields, and current Shields CEO Lee Cooper will take on a new executive role within WBA. Lucey partnered with Jack Shields 10 years ago to start the business and has led its operations for most of that time.

09:06 EDT Dutch Bros appoints Victoria Tullett as chief legal officer - Dutch Bros announced that legal expert Victoria Tullett has joined the drive-thru beverage company as its first chief legal officer. Tullett brings more than 20 years of experience helping organizations manage operational risk and achieve record levels of growth, compliance and profitability. Tullett assumed the role of chief legal officer on September 20. Prior to joining Dutch Bros, Tullett served Papa Murphy's for more than 20 years in various roles.

09:04 EDT Choice Hotels signs agreement with ServiceStar Capital - Choice Hotels signed an agreement on July 29, 2022, with Colorado-based real estate investment firm ServiceStar Capital Management to develop 21 new Everhome Suites hotels. This transaction represents Choice's largest investment in the brand, outlining a significant expansion across the U.S. with future Everhome Suites planned in Colorado, Arizona, Utah, Nevada and Florida over the next few years.

09:04 EDT Schneider, Torc Robotics announce pilot for autonomous test fleet - Torc Robotics announced that Schneider and Torc are working toward implementing a pilot program utilizing Torc's autonomous test fleet. As part of the agreement, Schneider will provide freight loads for Torc's pilot operations and unique insights on truckload freight that will help guide the development and ongoing commercialization of autonomous trucks for long-haul applications.

09:03 EDT Shuttle Pharmaceuticals signs manufacturing agreement for Ropidoxuridine - Shuttle Pharmaceuticals entered into an agreement with TCG GreenChem to manufacture Ropidoxuridine, the company's lead clinical sensitizer drug candidate, for use in formulating the drug product for testing in clinical trials of Ropidoxuridine and RT of cancers. In conjunction with manufacturing Ropidoxuridine, TCG GreenChem will perform process research, development and optimization work for Shuttle Pharma related to Ropidoxuridine and create working standards of starting materials and intermediates to support the qualitative/quantitative analysis of the drug reaction progress, determination of impurities, total mass balance and assay yields of the reactions. Shuttle Pharma will own all intellectual property and improvements developed through the Manufacturing Agreement. TCG GreenChem was founded by former pharma pharmaceutical executives with a track record in the development of hundreds of New Chemical Entities into the clinic and commercialization of pharmaceutical products.

09:02 EDT Microsoft raises quarterly dividend 10% to 68c per share - Microsoft announced that its board of directors declared a quarterly dividend of 68c per share, reflecting a 6c or 10% increase over the previous quarter's dividend. The dividend is payable Dec. 8, 2022, to shareholders of record on Nov. 17, 2022. The ex-dividend date will be Nov. 16, 2022.

09:00 EDT Compass sees pre-tax cash charge of $23M-$26M on workforce reduction - In a regulatory filing, Compass, Inc. disclosed that on September 20, the company "took significant action towards achieving a non-GAAP operating expense level in 2023 of $1.05 billion to $1.15 billion" with a workforce reduction as part of the company's cost reduction efforts previously highlighted on the company's August 15 earnings call. "The workforce reduction is separate from and in addition to the strategic actions that were reported on the company's Form 8-K dated June 14," Compass stated. "The company believes it is in a position to reduce its go forward investment in technology given the maturity of the company's technology platform. As a result, a significant portion of the workforce reduction involves reductions in headcount on the company's product and engineering team," the filing stated. The company currently estimates that as a result of the workforce reduction and non-material workforce reduction actions taken since the time the company filed its June 14 Form 8-K, it will incur a pre-tax cash charge of approximately $23M-$26M for severance and other termination benefits for employees whose roles were or are being eliminated during the quarter ending September 30. "The charge that the company expects to incur in connection with the workforce reduction and the non-material actions is subject to a number of assumptions, and actual expenses and results may differ materially from the company's estimates disclosed above," the filing stated.

08:50 EDT Bonum Health signs telemedicine services deal with Wakefern Food - TRxADE HEALTH announced that Bonum Health has signed a Telemedicine Services Distribution Deal with Wakefern Food Corp., to deploy telemedicine services throughout ShopRite pharmacy-led locations in New Jersey, New York, Pennsylvania, Connecticut, and Maryland. Bonum Health will provide affordable telemedicine services and prescription discount savings to ShopRite customers by offering Bonum Health's signature Mobile Health Services application and prescriber program, staffed by over 650+ Board-Certified Medical Providers. The service, which allows customers to connect virtually with doctors and healthcare providers, to get the care they need, also provides access to prescription discount savings through the innovative Bonum Health telemedicine application, which can be downloaded from both Google Play and Apple App stores.

08:48 EDT Yoshiharu appoints Gateway Group to lead investor relations - Yoshiharu Global has appointed Gateway Group to grow and lead its investor relations program, provide corporate messaging and engage with the investment community alongside the Company. Gateway will work closely with Yoshiharu's management team to develop and deploy a comprehensive outreach and communications program. Activities will include refining the Company's investment-oriented messaging and corporate positioning, strategic advisory services and introductions to institutional investors, sell-side analysts, and other key influencers in the broader financial community. Gateway will also assist in organizing roadshows and securing invitations to select financial conferences.

08:48 EDT SaverOne 2014: SaverOne Systems to be installed across Strauss Frito-Lay fleet - SaverOne 2014 (SVRE) announced that SaverOne Systems will be installed across Strauss Frito-Lay's entire fleet of food delivery trucks in Israel. This follows a successful trial period over a number of months, in which Strauss Frito-Lay tested all aspects of the system. Strauss Frito-Lay is a joint venture between Strauss Group, among the largest food manufacturers in Israel, and Frito-Lay, U.S. subsidiary of multinational food and beverage company, PepsiCo (PEP).

08:47 EDT Jupiter Wellness signs exclusive license agreement with Rejoy - Jupiter Wellness announced it has signed an exclusive licensing agreement with Rejoy to develop prescription products for the treatment of nipple neuropathies and associated sexual problems in women that have been treated for breast cancer. The exclusive license includes issued patents and technology, including formulations. In clinical studies, one topical formulation improved nipple sensitivity and alleviated associated sexual problems. Concomitantly, the formulation was also shown to increase female sexual lubrication and improve overall orgasmic response. The product has been named JW-500 to be added to a line of other clinical stage products currently under development at the Company. Jupiter Wellness plans to file for a pre-IND meeting with the US FDA within the next 12 months and intends to seek Orphan Drug Designation. An expedited 505 (b)(2) regulatory pathway for development is anticipated as the current formulation contains an already approved drug.

08:46 EDT Bank of America comfortable with NII growth, says CFO

08:45 EDT AppHarvest announces fall planting progress - AppHarvest announced it has completed calibration of its "touchless growing system" for salad greens at its 15-acre Berea, Ky., indoor farm by having successfully grown more than 20 varieties of lettuce and is approximately 80% complete with planting of its 30-acre AppHarvest Somerset Farm, which has thecapacity to grow about 1 million strawberry plants. The company's 60-acre flagship farm in Morehead, Ky., is expected to start harvesting itsthird season of tomatoesmid-fourth quarter. The AppHarvest Berea Farm is expected to be the world's largest high-tech farm for autonomously harvested salad greens with the latest "touchless growing system" by Green Automation. The hands-off system helps to improve both food safety and efficiency. To calibrate the touchless growing system, the company has successfully grown more than 20 types of salad greens, which go from seed to maturity in about three to four weeks depending on variety. AppHarvest expects commercial shipments from the Berea facility to start in the fourth quarter. The AppHarvest Berea growing environment leverages sunshine and rainwater and is automated for lighting, humidity and temperature. The farm uses a closed-loop irrigation system, which enables expected water savings of up to 90 percent compared to open-field farming and allows for precision dosing of nutrients, resulting in far less use of fertilizer compared to open-field farming while avoiding pollution from agricultural runoff. The AppHarvest Berea farm also employs integrated pest management-using good bugs to take care of bad bugs and early detection and prevention-to avoid the use of harsh chemical pesticides. The AppHarvest Somerset Farm is expected primarily to grow strawberries and is expected seasonally to grow cucumbers. The AppHarvest Somerset farm also uses sunshine, boosted with a hybrid LED lighting array when needed, and rainwater in a closed-loop irrigation system. AppHarvest also continues construction on its 60-acre Richmond, Ky. farm, which will double the company's capacity to grow tomatoes. Combined with the Morehead farm, the Richmond facility is expected to enable the company to grow about 1.5 million tomato plants per season thatcontinuously produce for more than 10 months of the year. The AppHarvest Richmond farm is expected to start producingbefore the end of 2022.AppHarvest currently sells to the top 25 national grocery store outlets as well as to select restaurants and food service providers through its distribution partner, Mastronardi Produce.

08:43 EDT Quantum Computing launches subscription service for Dirac 1 EQC system - Quantum Computing announced the launch of a subscription service that provides enterprises with access to its Dirac 1 Entropy Quantum Computing system. Dirac 1, QCI's first commercially available photonic EQC system, takes a different computational approach to existing quantum computing providers and can solve business problems with over 5,000 variables. Customers now have web-based access to Dirac 1, the same EQC that QCI used during the public Quantum Computing for Automotive Challenges event hosted and organized by the BMW Group in July. In that challenge, the EQC solved a large-scale optimization problem in six minutes and delivered a superior and feasible solution. The Company achieved this landmark result by applying this new quantum information processing technology to the BMW Vehicle Sensor Placement challenge, a complex problem constructed with 3,854 qubits and over 500 constraints. QCI will offer subscriptions to the EQC at various levels; from several hours per month to a fully dedicated system, depending upon customer requirements. Pricing will be competitive with subscription levels offered by others in the marketplace, but with significantly more availability and computational capability.

08:41 EDT CVW Cleantech announces upsize of private placement, grant of stock options - CVW CleanTech announces that as a result of significant investor interest, the non brokered private placement originally announced September 6, 2022, will be increased to allow for the issuance of up to 1,166,667 Units, with gross proceeds of up to $1.4 million. The Units are priced at $1.20 per Unit, and each Unit will be comprised of one common share and one share purchase warrant. Each warrant entitles the holder to acquire one common share at a price of $1.80 per share for a period of four years from the date of issuance. The common shares and warrants issued pursuant to the offering will be subject to a four month hold period from the closing date. The Offering is subject to the approval of the TSX Venture Exchange and is anticipated to close in early October 2022. CVW Cleantech also announces a grant of stock options to Akshay Dubey, the Chief Executive Officer of the Company, for the purchase of 2,600,000 shares of the Company, exercisable at a price of $1.35, with a term of 5 years to expiry. The grant is pursuant and subject to the terms and conditions of the Company's existing stock option plan and is subject to all regulatory requirements. The options will vest after a minimum of 18 months and after attaining certain performance and market-based conditions. This grant of options was first announced as part of the appointment of Mr. Dubey to the position of Chief Executive Officer on September 6, 2022, and is a component of an aggregate grant of options to Mr. Dubey to acquire 5,000,000 shares of the Company. In addition, five members of the Company's Board of Directors exercised 2.6 million stock options during the week ended September 16, 2022. Gross proceeds of $1.2 million were provided to the Company as a result.

08:40 EDT Centessa to present on OX2R agonist discovery pipeline - Centessa Pharmaceuticals announced that non-clinical data from its oral orexin receptor 2 agonist discovery pipeline have been accepted for poster presentation at the 26th Conference of the European Sleep Research Society meeting being held on September 27-30, 2022, in Athens, Greece. Centessa's OX2R agonists are designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1, with potential expansion into narcolepsy type 2, and other sleep disorders. The poster presentation will feature the non-clinical activity profiles of small-molecule OX2R agonists from multiple lead chemical series developed using structure-based drug design with an OX2R protein stabilized in the agonist conformation together with CryoEM and high-resolution protein crystallography. These novel OX2R agonist compounds showed high potency in activating recombinant human and endogenous mouse OX2Rs, with more than a thousand-fold selectivity for OX2R compared to OX1R. The OX2R agonists also showed efficacy in promoting wakefulness and in reducing cataplexy events in NT1 model mice, and increased wakefulness in healthy mice.

08:40 EDT FoxWayne Enterprises Acquisition Corp trading resumes

08:39 EDT HeartSciences granted US patent for ECG assessment of heart diastolic function - Heart Test Laboratories announced that it has been granted a patent from the United States Patent and Trademark Office, USPTO, for ECG quantification of echocardiographic measures of diastolic function of the heart using AI methods. HeartSciences' first device, the MyoVista Wavelet ECG leverages AI machine learning to detect cardiac dysfunction that cannot be diagnosed by current conventional ECGs. Its first algorithm is designed to provide diagnostic information related to impaired cardiac relaxation associated with diastolic dysfunction as well as all conventional ECG information in a single test. Andrew Simpson, Chief Executive Officer of HeartSciences, stated, "The ECG is a ubiquitous, relatively low-cost, simple and quick test that can be performed in a wide range of clinical settings by a non-specialist clinician or clinical aide. One of the most significant needs in healthcare is the ability to detect cardiac dysfunction early. Adding diagnostic information related to cardiac dysfunction to an ECG would not only make it a far more valuable cardiac screening tool, but also addresses a significant unmet need in the market with an estimated 100 million plus ECG tests performed annually in the USA alone. A growing body of published ECG research demonstrates that ECGs can have far greater clinical value and the grant of this patent reinforces our belief the HeartSciences is positioned at the forefront of what is expected to be a new era for ECGs. This latest patent is an important extension of our IP portfolio - providing significant prospective value for the company," concluded Simpson.

08:37 EDT Invitae's Ciitizen data utilized in Praxis' PRAX-222 IND filing - Invitae (NVTA) and Praxis Precision Medicines (PRAX) announced that real-world clinical insights from Invitae's Ciitizen platform were utilized as natural history data to support the submission of Praxis' Investigational New Drug, IND, application for PRAX-222 for the treatment of pediatric patients with early-onset SCN2A developmental and epileptic encephalopathy. Praxis announced earlier this month that the U.S. Food and Drug Administration, FDA, cleared the IND application for the initial dose cohort for the PRAX-222 EMBRAVE clinical study. Invitae's Ciitizen platform enables the rapid and comprehensive collection and analysis of medical history data, which supports understanding of the patient population and disease severity, may be used as natural history data for regulatory submissions, and can inform protocol design and inclusion and exclusion criteria for clinical studies. "The comprehensive real-world clinical evidence generated through Invitae's Ciitizen platform was a critical component to the PRAX-222 IND application, integrating a significant amount of natural history data in a highly efficient manner to help bring PRAX-222 one step closer to SCN2A-DEE patients," said Steven Petrou, Ph.D., co-founder and chief scientific officer of Praxis. "In order to make real progress and offer hope to patients living with SCN2A-DEE and their caregivers, it requires a committed ecosystem and a community willing to consider innovative approaches to drug development. We look forward to our continued partnership with Invitae for PRAX-222 and for other precision medicines targeting rare genetic epilepsies with high unmet need." The data, collected on behalf of SCN2A-DEE patients or their parents/guardians, is de-identified and shared with their consent, and represent the aggregation of real-world clinical evidence for SCN2A-DEE patients. The data generated by Invitae's Ciitizen platform is comprehensive, leveraging the HIPAA right of access to gather full medical records, longitudinally, from all of the patients' sites of care.

08:35 EDT CACI awarded a $54.6M research contract to back U.S. AFC, Redstone Arsenal - CACI International has been awarded a $54.6M contract to support U.S. Army Futures Command AFC to provide mission expertise to the Assured Positioning, Navigation, Timing, and Space APNT/Space Cross Functional Team for the U.S. Army Futures Command at the Redstone Arsenal in Huntsville, Alabama. CACI was awarded this contract under the Department of Defense Information Analysis Center's DoD IAC multiple-award contract MAC vehicle. These DoD IAC MAC task orders are awarded by the U.S. Air Force's 774th Enterprise Sourcing Squadron to develop and create new knowledge for the enhancement of the DTIC repository and the R&D and S&T community. John Mengucci, CACI President and Chief Executive Officer, said, "CACI is proud to support the critical Assured Positioning, Navigation, and Timing mission. Through this opportunity, we will bring industry-leading mission expertise and innovative ideas to Redstone Arsenal to meet immediate and future warfighter needs."

08:34 EDT Evoke receives notice of allowance from USPTO for patent related to GIMOTI - Evoke Pharma announced the United States Patent and Trademark Office, USPTO, issued a Notice of Allowance for U.S. Application No. 16/469,092 for GIMOTI. When granted, the patent will cover methods for treating moderate-to-severe gastroparesis with metoclopramide with an intranasal route of administration. Once issued, the patent, entitled "Treatment of Moderate and Severe Gastroparesis," will expire in 2037. The patent will add to Evoke's existing U.S. Food and Drug Administration, FDA, Orange Book-listed patents and other patents in the EU, Japan, and Mexico. "The patent protects our Phase 3 clinical trial outcomes and data showing efficacy with nasal metoclopramide formulations for persons suffering from moderate-to-severe diabetic gastroparesis. The grant of this new patent further enhances Evoke's growing position in this market and our continued efforts to ensure patients and doctors have access to GIMOTI in the U.S.," commented Matt D'Onofrio, Chief Business Officer of Evoke Pharma. "Through market surveys and healthcare provider and patient anecdotes, we've learned that there is an imperative need for a nasal formulation of metoclopramide rather than the traditional standard of care. Therefore, we believe the transition from oral administration of metoclopramide to a nasal route is revolutionary for both patients and doctors, and we are thrilled to have IP protections in place to protect a novel product like GIMOTI," D'Onofrio continued.

08:32 EDT Blue Hat Interactive announces signing of MoU with Singapore partner - Blue Hat Interactive Entertainment Technology announced on September 20, 2022, Fujian Blue Hat Interactive Entertainment Technology, a wholly owned subsidiary of the Company, has signed a memorandum of understanding, MoU, with Bigg World Pet, a Singapore company, regarding being a general agent to develop and operate Company's business strategy games including "Mengqu Monopoly", and "Mengqu Game Box" in Southeast Asia. Chen Xiaodong, CEO of Blue Hat, said that through cooperation with Bigg, the Company can quickly and confidently open the Southeast Asian market with the help of Bigg's own operating channels, unique business model and blockchain technology, which in turn helps the Company improve our global layout capabilities.

08:29 EDT BofA has 'a lot of time' to meet capital requirement minimum, says CFO

08:25 EDT Bank of America CFO says deposit balances remain 'steady at record levels'

08:24 EDT Zai Lab to present analysis from Phase 3 PRIME study of ZEJULA - Zai Lab will present a poster featuring initiation timing analysis from the Phase 3 PRIME study of ZEJULA as maintenance therapy at the upcoming 2022 International Gynecologic Cancer Society, ICGS, Annual Meeting. This post-hoc analysis of the PRIME Phase 3 study evaluated adults with newly diagnosed advanced ovarian cancer who responded to first-line platinum-based chemotherapy, and they were randomized to receive niraparib maintenance treatment or placebo within 12 weeks after chemotherapy completion. The results are as follows: For patients who received niraparib treatment less than 9 weeks after chemotherapy completion, the median progression-free survival was measured at 29.4 months with niraparib versus 8.3 months with placebo. For patients who received niraparib at 9 - 12 weeks after chemotherapy completion, the median PFS was 24.7 months with niraparib versus 10.8 months with placebo. The initiation timing of niraparib maintenance treatment had no significant impact on its safety profile. "We are excited to be presenting at the 2022 International Gynecologic Cancer Society Annual Meeting showing these results improved clinical efficacy when niraparib maintenance treatment is initiated within 12 weeks after chemotherapy in patients with advanced ovarian cancer," said Alan Sandler, M.D., President and Head of Global Development, Oncology, Zai Lab. "This study further supports ZEJULA as an important maintenance treatment therapy after platinum-based chemotherapy in people with advanced ovarian cancer."

08:22 EDT Otonomo Technologies' The Floow unveils FloowFusion technology - Otonomo Technologies announced that The Floow, an Otonomo company, has unveiled FloowFusion, a breakthrough new technology that enables insurance providers to easily leverage connected vehicle data with existing smartphone data to power connected insurance policies. Following Otonomo's acquisition of The Floow, FloowFusion is the first solution of its kind that can bring together The Floow's smartphone-based insurtech solution with connected vehicle data available through the Otonomo Smart Mobility Data Platform, providing access to unique insights that will transform the way auto insurance is written and managed. With FloowFusion, insurance providers can easily leverage mobile and vehicle telematics data to create new connected insurance policy offerings, as well as bolster existing offerings with additional highly accurate data sources to deliver a competitive advantage.

08:20 EDT MiMedx announces launch of AXIOFILL - MiMedx Group announced the launch of AXIOFILL, an Extracellular Matrix Particulate product derived from human placental tissue. AXIOFILL is the first and only human placental-derived particulate product available for Surgical Recovery procedures. The existing market for xenograft products, including particulates, is estimated at $230M. AXIOFILL provides a cost-effective human collagen scaffold that is conducive for use in large, complex wounds and those of irregular geometries. "The launch of AXIOFILL is particularly significant for MIMEDX," said Rohit Kashyap, Ph.D., MIMEDX President, Wound Care & Surgical. "We have added another new product to our portfolio that is designed for the needs of the Surgical Recovery market, enhancing the value we provide to customers. As the first human placenta-derived ECM particulate, we believe that AXIOFILL offers a distinct advantage over other particulate products and provides impressive clinical utility for physicians treating complex surgical wounds. Importantly, we continue to execute on our customer needs-driven innovation roadmap and view AXIOFILL as a strong platform for future product innovation."

08:20 EDT FoxWayne Enterprises Acquisition agrees to business combination with Clover Inc. - Clover Inc., which identifies itself as "a highly rated live streaming company focused on Gen Z and Millennial audiences and creators," and FoxWayne Enterprises Acquisition Corp., a special purpose acquisition company, announced they have entered into a definitive business combination agreement. Upon closing of the transaction, which is currently anticipated to occur in the first quarter of 2023, the combined company will be named "Clover Media Inc." and will be led by Isaac Raichyk, Chief Executive Officer of Clover, and the current management team. The combined company's common stock is expected to continue to be listed on the Nasdaq Capital Market. "We are deeply committed to advancing Clover's exciting live streaming platform. This transaction is expected to accelerate the development of our lead offerings for over 9 million and growing users," said Raichyk. As part of the transaction, FoxWayne will be issuing 15.745M shares of its common stock, which represents consideration of approximately $157.45M. Current Clover stockholders will convert 100% of their existing equity interests into common stock of the combined company and will own a majority of the outstanding shares of the combined company post-closing. Assuming no redemptions of FoxWayne shares, the combined company's cash resources are expected to be comprised of approximately $13.7M in cash proceeds currently in trust, along with the existing cash resources of Clover at closing. The boards of directors of both Clover and FoxWayne have unanimously approved the proposed transaction. The transaction is subject to, among other things, the approval of the stockholders of both Clover and FoxWayne and satisfaction or waiver of the conditions stated in the definitive business combination agreement.

08:19 EDT Alimera reimbursement of uveitis indication granted for ILUVIEN in Ireland - Alimera Sciences announces that Alimera Sciences Europe Limited, its Ireland-based European subsidiary, has been granted reimbursement for ILUVIEN 0.19 mg sustained release intravitreal implant for non-infectious uveitis affecting the posterior segment in Ireland. Reimbursement was granted by the Health Service Executive Corporate Pharmaceutical Unit and National Centre for Pharmacoeconomics in Ireland in line with its label in Europe. "We continue to expand the availability of our non-infectious uveitis indication in our International Segment with it now accessible to patients in all of our direct markets in addition to our key distributor markets," said Rick Eiswirth, President and Chief Executive Officer of Alimera. "We are excited to make ILUVIEN available for patients suffering from this persistent inflammatory condition and give physicians in these countries a better tool to help their patients see better, longer, with fewer injections."

08:17 EDT Shoals Technologies, Nextracker unveil new North-South BLA trunk bus product - Shoals Technologies and Nextracker unveiled a new North-South Big Lead Assembly, BLA, trunk bus product. Shoals' latest innovation will be on display at the RE+ trade show in Anaheim, California, September 20-22. To address challenges associated with site access, Shoals and Nextracker collaborated to innovate a new North-South BLA trunk product, which is specially optimized for NX HorizonTM tracker rows. In this North-South BLA product, the trunk bus runs parallel, rather than perpendicular, to the torque tube and transition boxes along the North-South row step down the size of the trunk bus along the tracker rows. Without any structures to impede site access, ongoing power plant O&M is simpler and faster. Compared to conventional in-field North-South wiring methods, Shoals North-South BLA delivers a 43% savings in PV wiring installation labor, a 60% savings in DC wiring O&M, and a 0.25% increase in energy yield due to less DC wiring voltage drop. "We are proud to partner with Nextracker to make our leading solar ecosystems work optimally together, resulting in utility-scale solar that is more cost effective for our customers," said Jason Whitaker, Chief Executive Officer of Shoals. "We will continue to innovate collaboratively with Nextracker to enhance our North-South BLA product to further optimize its architecture and installation methodologies, enabling even more cost savings."

08:15 EDT Cybin cites 'achievements research and development milestones' - "Cybin announced that it has successfully achieved its research and development milestones that helped to build and progress its innovative pipeline of investigational psychedelic therapeutics ahead of projected timelines," noted the company. These milestones were set forth in the acquisition agreement of Adelia Therapeutics Inc. in December 2020. The achievement of these milestones has supported Cybin's transition from a discovery- to clinical-stage development organization in less than two years. "It is extremely gratifying that we have been able to progress our ambitious R&D pipeline - from discovering new drug candidates to entering the clinic - ahead of our projected schedule," said Doug Drysdale, Chief Executive Officer of Cybin. "Our clinical development work continues in earnest, and with each day we get closer to our goal of creating new psychedelic-based treatments for mental health conditions and potentially improving the patient and therapist experience across multiple indications. Our commitment to bringing these important and new potential treatments to patients in need and delivering value to all our stakeholders is unwavering."

08:14 EDT Blackstone, Bourne Leisure agree to sale of Butlin's - Blackstone and Bourne Leisure announced that funds managed by Blackstone's private equity and real estate businesses have agreed to the sale of Butlin's, the British seaside resorts, to a newly formed company backed by the Harris family. Lionel Assant, European Head of Private Equity, Blackstone, said: "Staying true to our high-conviction investment approach, we believe we are well positioned to drive the continued success of both the Haven and Warner businesses. Proceeds from the Butlin's sale will enable us to continue delivering our ambitious investment programmes across both brands, supporting upgrades to the existing estates and adding new sites to the portfolio, to the benefit of millions of customers. Butlin's is in a strong position to take advantage of the continued growth in the staycation market, and I have no doubt it will continue to flourish. We wish everyone there every success for the future."

08:13 EDT Infinera, Iscte collaborate to provide students modernized technology lab - Infinera and Iscte - Instituto Universitario de Lisboa announced plans to collaborate on modernizing the university's Department of Information Science and Technology lab to support students' educational journey, providing them with equipment, optical networking research and development projects, and internships that offer real-world, firsthand experience. Infinera will offer students the opportunity to intern at Infinera's Lisbon campus, where students will be able to observe, learn, and participate in research and development projects. "As a global leader in optical networking solutions, Infinera is proud to support future technology engineers, innovators, and pioneers," said Goncalo Crispim, Country Manager at Infinera. "Collaborating with Iscte to inspire and empower our next generation of talent enables us to move forward together and build a more connected society."

08:12 EDT Stem in joint solar, storage, and EV charging offering with InCharge Energy - Stem announced its partnership with InCharge Energy, a fleet electrification services leader, to equip businesses with a complete EV fleet infrastructure solution to maximize their charging assets. The offering combines Athena , Stem's clean energy management platform, with InCharge Energy's "In-Control" software platform, giving fleet owners the tools to manage EV charger loads with clean energy using solar and storage, optimize utility bills, build out EV charging in areas of the grid that are constrained, and monitor progress toward environmental, social and governance goals.

08:11 EDT MicroStrategy acquired about 301 bitcoins for $6M from August 2 to September 19 - In a regulatory filing, MicroStrategy announced that, during the period between August 2 and September 19, MicroStrategy acquired approximately 301 bitcoins for approximately $6.0M in cash, at an average price of approximately $19,851 per bitcoin, inclusive of fees and expenses. MicroStrategy purchased the bitcoins using excess cash. As of September 19, MicroStrategy, together with its subsidiaries, held an aggregate of approximately 130,000 bitcoins, which were acquired at an aggregate purchase price of approximately $3.98B and an average purchase price of approximately $30,639 per bitcoin, inclusive of fees and expenses.

08:10 EDT Porch Group's Floify announces technology partnership with NAMB - Porch Group announces that Floify has partnered with National Association of Mortgage Brokers, NAMB, as a Technology Industry Partner. This is the first year the organizations have partnered to advance the mortgage industry. Additionally, Floify has been recognized as a Service Partner of the Year by the NAMB as part of its 2022 Recognition Awards. "We are proud to be recognized by NAMB for our contribution to the industry in the software and technology space," said Floify's President and General Manager, Sofia Rossato. "This partnership and recognition is a testament to our company's ongoing commitment to growth and innovation, which is strengthened through our integration with our parent company, Porch Group."

08:08 EDT Eargo announces proxy solicitation for 2022 annual meeting - Eargo announced that it had begun its proxy solicitation for the 2022 Annual Meeting of the Stockholders to be held on Wednesday, October 12, 2022 at 11 A.M. Pacific Time. The Company filed its definitive proxy Statement for the Annual Meeting on September 13, 2022 and has commenced mailing of the Definitive Proxy Statement and related proxy materials to stockholders of record as of the close of business on September 6, 2022. Christian Gormsen, President and CEO, said, "Today we are announcing our proxy solicitation campaign and web site to stress the importance that Eargo stockholders vote on a number of critical proposals that are key to the Company's future. Specifically, Eargo and its Board of Directors urge stockholders to vote FOR Proposals Four, Five and Six. We encourage stockholders to visit our newly launched web site for important background and detailed information on why and how to vote. We truly appreciate your continued support of Eargo."

08:08 EDT Stryker receives FDA 510(k) clearance for OptaBlate bone tumor ablation system - Stryker announced that its OptaBlate bone tumor ablation system received 510(k) clearance from the U.S. FDA. The addition of the OptaBlate technology to Stryker's Interventional Spine portfolio expands on its core competencies in vertebral augmentation and radiofrequency ablation and completes its portfolio of treatment options for metastatic vertebral body fractures.

08:06 EDT Leidos awarded contract to support Federal Highway Administration policy - Leidos has been awarded a new Blanket Purchase Agreement by the U.S. Department of Transportation to provide program and technical support to the Federal Highway Administration's Office of Policy and Governmental Affairs. The multiple-award BPA contract has a five-year base period of performance followed by a six-month option period. It holds an estimated value of $60M. Work will be performed at multiple Leidos facilities. Through this contract, Leidos will support FHWA efforts to develop highway and intergovernmental policy positions, analyze the impact of investment on transportation performance and the economy, and enhance the administration's strategic plan and performance management processes. This will enable expert consultation services on cutting-edge data acquisition and demand modeling.

08:06 EDT FOXWU Stock trading halted, news pending

08:05 EDT Zebra Technologies and ARC team to further biology research in Australia - Zebra Technologies announced Bespoke Manufacturing Company, BMC , an apparel manufacturer, selected S&H Systems, Inc. and Zebra's Fetch autonomous mobile robots and fixed industrial scanners to improve visibility and productivity. Zebra's solution will improve BMC's workflow visibility from the initial printing and cutting of fabric to the final phase of packing and shipping, increasing efficiency and productivity and allowing the manufacturer to scale up to meet growing demand. Australia's commitment to the growing market of synthetic biology is made clear by the long-term funding commitment from the ARC in synthetic biology. 'Australia has all the hallmarks required to enable a successful and sustainable synthetic biology future,' says Dr Emily Leproust, Ph.D., CEO and co-founder of Twist Bioscience. 'The partnership will provide researchers access to our industry leading DNA synthesis products. We gain access to the capabilities and availability of CoESB members to shape new products, while they are able to gain early access to upcoming products within Twist's synthetic biology product program.'

08:05 EDT Playa Hotels & Resorts re-authorizes $100M share repurchase program - Playa Hotels & Resorts has re-authorized the repurchase of up to $100M of the company's outstanding ordinary shares. Depending on market conditions and other factors, these repurchases may be commenced or suspended from time to time without prior notice.

08:04 EDT OptimizeRx extends exclusive partnership with Therapy Brands - OptimizeRx announced a renewed exclusive partnership agreement with Therapy Brands, leveraging their NewCrop solution, a leading electronic prescribing service trusted by hundreds of EHRs nationwide. The new agreement is an extension of the exclusive partnership between Therapy Brands and OptimizeRx initiated in 2019. The agreement gives NewCrop's ePrescribing platform unparalleled access to innovative resources for healthcare professionals via the OptimizeRx Therapy Initiation and Persistence Platform, which provides the most comprehensive diagnosis support, affordability, access, and adherence resources. "We continue to see great benefit in this partnership and are enthused that we're extending this exclusive agreement," commented Steve Silvestro, Chief Commercial Officer, OptimizeRx. "It is a testament to the pioneering mindset of both of our companies in continuing to strengthen HCP access to valuable treatment information and resources for themselves and their patients. The expansion of this alliance further cements our leadership in contextual point-of-care HCP messaging as we consistently leverage an increasing number of touchpoints throughout the patient journey with our best-in-class platform."

08:04 EDT Medtronic receives FDA clearance for expanded indication of LINQ II ICM system - Medtronic announced the LINQ II Insertable Cardiac Monitor system is the first-and-only ICM to receive 510(k) clearance by the U.S. FDA for use in pediatric patients over the age of 2 who have heart rhythm abnormalities and require long-term, continuous monitoring.

08:04 EDT Citizens Financial enters power purchase agreement with Orsted - Citizens announced that it has entered into a power purchase agreement with Orsted, supporting the construction of the Sunflower Wind Project, which will match 100% of Citizens' power consumption across its entire operational footprint with renewable energy credits. The Sunflower Wind Project is a 200-Megawatt wind generation facility in Marion County, Kansas. Orsted began construction of the project in 2022 and by 2023 it is expected to generate enough electricity to power approximately 96,000 homes annually. Citizens' share of the project is 25.8 MWs.

08:03 EDT Humacyte expands board of directors, leadership team with new appointments - Humacyte announced the appointments of two healthcare professionals to the Company's Board of Directors and leadership team. Lt. General Bruce Green, M.D., USAF-ret., former Surgeon General of the U.S. Air Force, joins as a member of the Board of Directors. In addition, pharma industry veteran Yang Cao, Ph.D. joins as the Company's Chief Regulatory Officer. Current Chief Regulatory Officer, Bill Tente, will remain with Humacyte as an Executive Advisor, partnering on regulatory initiatives for the organization with Dr. Cao and team. General Green served as Assistant Surgeon General for Health Care Operations and Deputy Surgeon General, and was appointed Air Force Surgeon General in 2009. Prior to joining Humacyte, Dr. Cao served as Senior Vice President and Head of Regulatory Affairs and Quality Assurance at Ascentage Pharma.

08:02 EDT Lithium Americas enters collaboration agreement with Green Technology Metals - Lithium Americas entered a Strategic Collaboration Agreement with Green Technology Metals to advance a common goal of developing an integrated lithium chemical supply chain in North America. In North America, Lithium Americas is focused on developing its 100%-owned Thacker Pass project in Humboldt County, Nevada. The Company has received all federal and state permits necessary to begin construction and awaits a ruling on an appeal filed against the Bureau of Land Management on the issuance of the Record of Decision. The Company is actively preparing to commence construction, including planning early-works construction for late 2022, finalizing the selection of an engineering, procurement and construction management firm, hiring lead construction and project management roles, advancing financing and offtake discussions, and progressing the U.S. Department of Energy Advanced Technology Vehicles Manufacturing loan program. Following Lithium Americas' strategic equity investment of US$10 million in April 2022 and entry into an initial non-binding collaboration framework agreement with GT1, this Collaboration Agreement provides non-exclusive rights for Lithium Americas and GT1 to undertake collaborative activities. This agreement represents a further step forward for both parties in their goal towards the joint development of midstream and downstream processing strategies and routes for battery-grade lithium chemicals in Ontario and across North America. The Collaboration Agreement is intended to encourage increased communication and knowledge-sharing between Lithium Americas and GT1's management and technical teams, with the following objectives: Develop an integrated technical working group to consult on improving assets, metallurgical and process recoveries, and the refining of battery-grade chemical products; Share resources and knowledge of early-stage lithium spodumene resources in North America, including consultations on findings, developments, new techniques and opportunities; Leverage Lithium Americas' Lithium Technical Development Center in Reno for testing and processing of hard rock lithium ore into intermediate and final lithium products; Develop midstream and downstream processing strategies and routes for battery-grade lithium chemicals in Ontario and across North America; Advance development plans and project financing for an integrated lithium chemicals business to deliver an integrated supply chain battery-grade chemical solution to customers; and Engage offtake and downstream partners and customers. The Collaboration Agreement includes the establishment of a Strategic Management Committee comprised of equal representatives from Lithium Americas and GT1, to discuss strategic opportunities for joint exploration or development and pursuit, establish a strategy development framework and facilitate and oversee a joint development plan. There are no conditions precedent to the Collaboration Agreement and the Collaboration Agreement can be mutually terminated for convenience by 30 days' notice. There are no formal requirements on either Lithium Americas or GT1 to provide service in kind of a certain value or to commit funds towards the objectives of the Collaboration Agreement.

08:01 EDT Sientra receives regulatory approval to market breast implants in Saudi Arabia - Sientra announced that it has received approval from the Saudi Food & Drug Authority to market the Company's line of smooth surface, High-Strength Cohesive silicone gel breast implants in the Kingdom of Saudi Arabia. Ron Menezes, President and Chief Executive Officer of Sientra, said, "The swift SFDA approval of Sientra implants for the KSA market represents another stamp of approval from the global community which is actively seeking Sientra's products to address the needs existing manufacturers fail to meet, and is a testament to the quality Sientra brings in safety, innovation and execution. As the largest country in the Middle East and GCC, and a growing aesthetics hub for the region, we see the Kingdom of Saudi Arabia as the tremendous launchpad for our international expansion efforts into the Middle East region." This is the second new expansion market for the company in 2022, reaching a new milestone in global reach to provide even more patients with both choice and safety.

07:48 EDT Logiq announces digital marketing initiatives for EV charger installation - Logiq announced that it has strengthened its position in the high-growth home improvement vertical arena for the electric vehicle charger installation industry. Haig Newton, President of DataLogiq, Inc., commented, "Our team recognized the growing demand as many of our construction and electrical clients were interested in gaining access to the growing EV home, multifamily and commercial charger installation marketplace. As such, we launched our on-demand digital marketing platform system to allow our clients to meet this dynamic market opportunity." Sales of electric cars doubled in 2021 to a new record of 6.6 million. That growth contributed to the total 16.5 million electric vehicles on the road in 2021, more than triple the number in 2018. Demand for charging stations continues to grow apace with EV sales, though not evenly distributed across the U.S. California leads the country in total stations available, while many southern states have far fewer stations per capita.

07:39 EDT Ivanhoe Electric provides update on exploration at Tintic Copper-Gold project - Ivanhoe Electric Chairman and CEO Robert Friedland and President Eric Finlayson are pleased to provide an update on recent exploration activities at the Tintic Copper-Gold Project in Utah. As part of the targeting program underway ahead of the future exploration drill program, Ivanhoe Electric has re-sampled drill core from a number of historic holes. Recent high-grade re-assay results have continued to enhance the Company's understanding of the Tintic District and have shown that high-grade copper and precious metals mineralization may be present nearby to existing historic underground mine infrastructure. Speaking at the Denver Gold Group - Gold Forum Americas, Friedland commented: "We continue to be astounded by the high-grade mineral potential of the Tintic District. A lot of copper, gold, silver, lead and zinc ended up at Tintic, and it certainly did not fall from the sky. These results from the New Park Reserves area continue to demonstrate that the old-timers did not mine all of the high-grade copper, gold and silver. In addition, these results provide further evidence of the presence of one or more large-scale porphyry copper-gold deposits located at depth at Tintic. Using our proprietary high-powered Typhoon geophysical surveying system we completed a 72 square kilometer three-dimensional induced polarization and resistivity survey and imaged three large-scale anomalies - each comparable with the scale of the nearby Bingham Canyon copper-gold mine. Bingham Canyon has milled more than 2.7 billion tonnes of copper and gold-bearing rocks and produced over 20 million tonnes of refined copper metal and more than 28 million ounces of gold over the past 119 years. Our geologists continue to identify new features that support the thesis that one or more of these Typhoon anomalies may be the porphyry targets that have produced all of the copper and precious metals in the historic Tintic District. These anomalies are located at depth from surface, meaning any potential mining operation at Tintic would likely be an underground operation."

07:38 EDT Mind Medicine announces first dosing in Phase 1 trial of MDMA-like substances - Mind Medicine announced the first patient has been dosed in a Phase 1 investigator-initiated study led by MindMed collaborators. The study aims to evaluate the effects of MDMA-like substances, including MDA, Lys-MDMA, Lys-MDA, versus a placebo in healthy volunteers.By using pharmacokinetics and modern psychological and psychometric tests, this study will investigate the potential to better control the bioavailability, slow the effect onset and reduce possible adverse effects of MDMA and MDA by using these prodrugs. The study will also investigate effects of MDA in direct comparison with MDMA for the first time in humans. The Phase 1 clinical trial plans to enroll 24 healthy subjects who will receive MDMA, MDA, Lys-MDMA, Lys-MDA , and placebo. The primary outcome measures for this study will assess acute subjective effects using Visual Analog Scales assessing the intensity and duration of subjective effects on a scale as well as plasma levels of MDMA and MDA at each study day across the 18-month study period.

07:35 EDT Biomea Fusion presents preclinical data on BMF-219 - Biomea Fusion presented "Oral menin inhibitor, BMF-219, displays a significant and durable reduction in HbA1c in a type 2 diabetes rat model", the first of two oral presentations at the EASD Annual Meeting. These data further support BMF-219's potential as an oral, long-acting, disease-modifying treatment for type 2 diabetes."Today we reported new data demonstrating BMF-219's ability to improve HOMA-B scores to the range of normal pancreatic beta cell function with 4-week oral treatment in the ZDF rat model of type 2 diabetes. This data provides mechanistic support that the durable glycemic control and significant reduction of HbA1c achieved by BMF-219 is the result of improved beta cell function," said Priyanka Somanath, Biomea's Associate Director of Translational Research. Biomea's second accepted abstract "Oral long-acting menin inhibitor normalizes type 2 diabetes in two rat models" will be presented during the session 'OP 33 Therapy Outside the Box' on Thursday, September 22 at 15:30-15:45 CEST. Menin, a transcriptional scaffold protein, regulates pancreatic beta cell homeostasis; inhibiting menin function with BMF-219 increased beta cell function in a preclinical animal model, driving an improvement in glycemic control and insulin sensitivity. New data presented in a Short Oral Discussion, at EASD in Stockholm, Sweden, highlights the ability of BMF-219, a covalent menin inhibitor, to restore normal HOMA-B, a measure of pancreatic beta cell function, over 4-weeks of treatment in the Zucker Diabetic Fatty Rat model of type 2 diabetes BMF-219 significantly lowered HbA1c compared to active control, liraglutide, -3.5% vs -1.7%, respectively. BMF-219 also outperformed liraglutide in reducing fasting glucose, fasting insulin, total cholesterol and triglycerides; furthermore, BMF-219 treatment resulted in a substantive weight loss Biomea remains on track to file an IND to study BMF-219 in patients with Type 2 Diabetes in the second half of 2022

07:35 EDT Invitae's citizen data used in Praxis Precision Medicines' PRAX-222 IND filing - Invitae (NVTA) and Praxis Precision Medicines (PRAX) announced that real-world clinical insights from Invitae's Ciitizen platform were utilized as natural history data to support the submission of Praxis' Investigational New Drug - IND - application for PRAX-222 for the treatment of pediatric patients with early-onset SCN2A developmental and epileptic encephalopathy, or DEE. Praxis announced earlier this month that the FDA cleared the IND application for the initial dose cohort for the PRAX-222 EMBRAVE clinical study. For many rare diseases, including certain severe genetic pediatric epilepsies such as SCN2A-DEE, natural history studies are not yet available to document the high disease burden and significant unmet medical need. Invitae's Ciitizen platform enables the rapid and comprehensive collection and analysis of medical history data, may be used as natural history data for regulatory submissions, and can inform protocol design and inclusion and exclusion criteria for clinical studies. The data, collected on behalf of SCN2A-DEE patients or their parents/guardians, is de-identified and shared with their consent, and represents the richest aggregation of real-world clinical evidence for SCN2A-DEE patients.

07:33 EDT OpGen subsidiary Curetis, FIND sign R&D collaboration agreement - OpGen announced the signing of an R&D collaboration agreement with FIND, the global alliance for diagnostics, for the Unyvero A30 RQ platform for use in rapid pathogen ID and AMR testing from blood culture samples in low and middle income countries, LMICs. The Unyvero A30 RQ platform is a sample to answer instrument running a disposable one-time use cartridge that can test for up to 33 diagnostic targets from a single specimen. Oliver Schacht, President & CEO of OpGen, commented, "We are excited to partner with FIND, in demonstrating that our Unyvero A30 RQ platform is ideally suited to being used in LMICs for rapid detection of AMR which is a truly global issue that must be addressed in a multilateral and indeed global fashion. The R&D contract and associated funding will support the required R&D efforts on our side and expedite such development." If successful, after demonstrating feasibility and completing this initial R&D project phase, both parties have agreed to discuss the option of a potential future collaboration and commercialization agreement between OpGen and FIND.

07:31 EDT Virax Biolabs launches monkeypox virus antigen rapid test kit - Virax Biolabs announced the distribution of a Monkeypox Virus Antigen Rapid Test Kits which has been launched in markets accepting the CE mark, such as the European Union. The test kits are for use in point of care settings and can help healthcare professionals accurately identify a monkeypox infection in people suspected of carrying the monkeypox virus with results typically available in 15 minutes. It also serves as initial screening test for individuals that have been exposed to monkeypox infected patients or a high-risk environment.

07:31 EDT Clear Secure, Virdee partner for frictionless hotel check-in - Virdee has announced it will implement CLEAR's secure identity platform to power its industry leading digital, self-service check-in solutions. The partnership marks the first integration within the hotel space for CLEAR and its 13 million members. CLEAR is now integrated into Virdee's suite of solutions as its preferred method for identity verification, strengthening the ease, security, and holistic reach of Virdee's platform. While checking into a hotel, existing CLEAR Members will verify their identity with a photo - while new users enroll for free with a few simple steps. As verified guests complete check in on the Virdee platform, they can process payment, customize the stay, receive a mobile or physical key, and head straight to room without stopping at the front desk. The partnership enables a seamless and predictable travel experience from air travel to car transportation to hotel check-in, avoiding long lines along the way.

07:27 EDT Alterity Therapeutics' IND application for MSA candidate approved by FDA - Alterity Therapeutics announced the approval of its Investigational New Drug - IND - application by the FDA to allow evaluation of ATH434 in individuals with Multiple System Atrophy, or MSA, a rare and highly debilitating Parkinsonian disorder. The approval of this IND authorizes Alterity to conduct its Phase 2 clinical trial in the U.S. The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will explore the effect of ATH434 treatment on neuroimaging and protein biomarkers, such as excess brain iron and aggregating alpha-synuclein. Patients will receive treatment for 12 months which will provide an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study.

07:18 EDT IBI Group awarded statewide contract with Florida Department of Transportation - IBI Group has recently been awarded a new statewide contract and contract extension with the Florida Department of Transportation for its Advanced Traffic Management Systems portfolio. The contracts are expected to improve the State's ability to manage transportation networks and improve traveller safety and ease of travel. The continuation of work with the Florida Department of Transportation will allow IBI to build upon its working relationship and offer improved, intelligent solutions based on a history of working knowledge.

07:15 EDT AmeriDrive partners with HyreCar on $100M revolving line of credit joint venture - AmeriDrive Holdings announced a joint venture with HyreCar, through which it will significantly grow its fleet and geographic footprint. HyreCar, Inc. and AmeriDrive recently announced closing a $100M warehousing line of credit with a premier global investment bank and Medalist Partners. Under the agreement, AmeriDrive will use this facility to purchase vehicles for exclusive listing on the HyreCar platform. The announcement follows the recent addition of industry veteran Daniel Florence as COO of AmeriDrive, who will work closely with the HyreCar team to lead the joint venture as AmeriDrive scales its fleet by adding 6,000 to 7,000 cars over the next 12 to18 months. Under Florence's leadership, AmeriDrive will focus on optimizing the company's fleet operations to add inventory quickly and sustainably while maintaining high utilization. Through the new warehouse line of credit, AmeriDrive anticipates opening 40 more locations with a footprint in markets across the United States over the next 18 months.

07:11 EDT Renalytix announces change to board of directors, Berman to resign - Renalytix announces that Ann Berman, non-executive director and chair of the audit and nomination committees, has resigned as a director of the Company for personal reasons effective immediately. The Company has begun a process to appoint a non-executive director and committee chair successors.

07:10 EDT Apollo Silver commences Phase 2 drill program at Calico Silver Project - Apollo Silver announces that Phase 2 of the 2022 drill program has commenced at its Calico Silver Project, located in San Bernardino County, California. Reverse circulation drilling began September 19, 2022, on the Waterloo Property. The Phase 2 Drill Program is one component of the multi-component 2022 Calico Technical Program that aims to upgrade and expand the recently announced Inferred Mineral Resource Estimate of 166 million ounces of silver contained in 58.1 million tonnes at an average grade of 89 grams per tonne. "Phase 2 of the 2022 drill program has commenced on schedule," Apollo CEO Tom Peregoodoff commented. "The second phase of drilling will focus on the central and northern portions of the Waterloo resource and is designed to maximize the amount of silver which may be upgraded to a more advanced resource category and enable commencement of engineering studies in 2023."

07:08 EDT Versus Systems appoints Pruitt to board of directors - Versus Systems announced the appointment of Shannon Pruitt to its Board of Directors. As the Global Chief Content Officer of Stagwell Media Network, Pruitt partners with agency CEOs, clients, publishers, creative, entertainment, sports and gaming companies to develop innovative partnerships, products and solutions to grow and scale the businesses and their offerings. The addition of Pruitt to the Versus board bolsters the Company's existing professional sports partnerships and expansion into Over-the-Top streaming and media, Corporate Events, and experiential marketing agencies.

07:08 EDT Scholar Rock appoints Jay Backstrom, M.D CEO - Scholar Rock announced that its Board of Directors appointed Jay Backstrom, M.D., M.P.H., as Chief Executive Officer-Elect, effective September 20. Dr. Backstrom will work closely with Founding and Interim CEO Nagesh Mahanthappa, Ph.D., M.B.A., before officially assuming the role of President & CEO on October 20 , at which time he will also join the company's Board of Directors.

07:06 EDT FDA grants rare pediatric disease designation to Avrobio's AVR-RD-04 - Avrobio announced that the U.S. Food and Drug Administration has granted rare pediatric disease designation to AVR-RD-04, an investigational gene therapy for the treatment of cystinosis, a life-threatening disease that causes progressive multi-organ damage, including early, acute kidney disease progressing to end-stage kidney disease. FDA's Rare Pediatric Disease Designation and Voucher Program is intended to facilitate the development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. Companies that receive approval for a New Drug Application or Biologics License Application for a rare pediatric disease may be eligible to receive a voucher for a priority review of a subsequent marketing application for a different product. The priority review voucher may be used by the company or sold to a third party. AVR-RD-04 is designed to genetically modify patients' own hematopoietic stem cells to express the gene encoding cystinosin, the protein that is critically deficient in people living with cystinosis. Preliminary data from the ongoing University of California San Diego Phase 1/2 clinical trial suggest that this approach is well tolerated, with no adverse events related to the drug product reported to date. All AEs reported were related to myeloablative conditioning, stem cell mobilization, underlying disease or pre-existing conditions. The majority of AEs were mild or moderate and resolved without clinical sequelae. Clinical data to date indicate this investigational approach provides benefits in multiple tissues evaluated, including the eyes, skin, gastrointestinal mucosa and the neurocognitive system. The collaborator-sponsored Phase 1/2 clinical trial is funded in part by grants to University of California San Diego from the California Institute for Regenerative Medicine , Cystinosis Research Foundation and National Institutes of Health .

07:05 EDT Singing Machine enters partnership with Sam's Club - The Singing Machine Company announced it has launched 3 new karaoke products into over 550 Sam's Club locations nationwide and 1 new item into more than 100 Sam's Club Mexico locations. The new fall program will feature the new Singing Machine Singcast Ultimate, Singing Machine Groove Mini, and Party Machine Duet Microphones. This program is intended to appeal to a wide variety of consumers as the Company heads into the peak holiday season.

07:04 EDT Xos, ShipX enter partnership to accelerate adoption of battery-electric vehicle - Xos announced a partnership with delivery solutions provider ShipX to accelerate the adoption of battery-electric vehicles into delivery fleets. As part of the agreement, ShipX will promote the purchase or lease of Xos battery-electric vehicles amongst its clients and Xos may offer discounts or incentives to those clients. "Xos and ShipX share a common belief that the way we move goods should be smarter, cleaner, and more efficient, so working together is a natural fit," said Giordano Sordoni, Chief Operating Officer and Co-Founder of Xos. "With ShipX as a partner, we're excited to continue offering our customers the best possible delivery solutions available today."

07:03 EDT MediWound says EMA accepts application for NexoBrid extended indication - MediWound announced that the European Medicines Agency has validated for review the Type II Variation submitted by MediWound in order to expand the current approved indication for NexoBrid into the pediatric population. MediWound expects a decision from the European Commission in the first quarter of 2023. EMA has initiated evaluation of the application to extend the use of NexoBrid to children aged newborn through eighteen. The submission is supported by the interim results of a global, Phase 3 trial, evaluating the safety and efficacy of NexoBrid in hospitalized pediatric patients, and by additional data available from children who participated in the EU phase 3 study and phase 2 studies conducted during the clinical development of NexoBrid.

07:02 EDT BorgWarner to acquire charging business of Hubei Surpass Sun Electric - BorgWarner and Hubei Surpass Sun Electric or SSE have entered into an Equity Transfer Agreement under which BorgWarner has agreed to acquire the Electric Vehicle Solution, Smart Grid and Smart Energy businesses of SSE. The transaction has an enterprise value of up to RMB410M, of which approximately RMB267M would be delivered at or soon after closing. Up to RMB143M could be paid in the form of contingent payments over approximately two years following the closing. Headquartered in Xiangyang, Hubei province, China, SSE's electrification business supplies patented electric vehicle charging solutions to customers in China and more than 70 other countries. SSE's 2022 revenues for the electrification business are expected to be approximately RMB180M. The transaction is subject to satisfaction of customary closing conditions and SSE shareholder approval. The closing is expected in 1Q23.

07:01 EDT Skye Bioscience completes drug production of SBI-100 for Phase 1 clinical study - Skye Bioscience has been advised by its contract manufacturer that it has completed the production of SBI-100 Ophthalmic Emulsion for Skye's Phase 1 clinical trial. The final drug product will be released and available for clinical use in October, following receipt of acceptable results from quality and analytical testing that has been initiated. "We are pleased to have completed this critical step toward initiating enrollment for our first-in-human study for SBI-100 OE," said Punit Dhillon, CEO and Chair of Skye. "Our team is scheduled to conduct our clinical site initiation in the second week of October to train staff and investigators of our clinical partner, CMAX, in Australia. Following site initiation and release of SBI-100 OE drug product, we expect dosing in subjects to begin in November."

06:49 EDT Stantec awarded $16M feasibility study for Resolution Copper - Stantec (STN) has been selected by Resolution Copper Mining to deliver a $16M feasibility study providing engineering and technical services for the Resolution Copper mine in Superior, Arizona. The proposed underground mine has the potential to be one of the largest producers of copper in North America-supplying up to 25% of US copper demand each year. Copper from the mine will be used in products that are vital to the energy transition, such as electric vehicles, batteries, solar panels, wind turbines, and more. Resolution Copper is a limited liability company that is owned by Rio Tinto (RIO) (55%) and BHP (BHP) (45%). Stantec has been a lead underground mining and infrastructure consultant on the project since early 2019. Stantec will assist Resolution Copper by providing engineering and execution planning services for the mine.

06:46 EDT Merck to initiate new Phase 3 program for once-daily islatravir - Merck announced that the company will initiate a new Phase 3 clinical program with once-daily islatravir for the treatment of people with HIV-1 infection. These new Phase 3 studies will evaluate a once-daily oral combination of doravirine 100 mg and a lower dose of islatravir. One study will evaluate DOR/ISL in previously untreated adults with HIV-1 infection and two studies will evaluate DOR/ISL as a switch in antiretroviral therapy in adults with HIV-1 infection who are virologically suppressed. Certain study participants currently enrolled in once-daily treatment studies with DOR 100 mg/ISL 0.75 mg will have the option of transitioning to a new study with the lower islatravir dose. The U.S. FDA has reviewed and agreed with this plan. The investigational new drug application for the once-daily oral DOR/ISL treatment program remains under a partial clinical hold for any studies that would use doses higher than the dose to be studied in the new Phase 3 program. Refer here for more information on the islatravir clinical hold.

06:37 EDT Zedge announces pilot program with Saregama master recordings for ringtones - Zedge announced a pilot program that avails Zedge users with access to 1,000 of Saregama's master recordings for ringtones. Saregama India owns the largest music archives in India and one of the biggest in the world.

06:35 EDT ViewRay announces MD Anderson Cancer Center purchase of MRIdian therapy system - ViewRay announced that the University of Texas MD Anderson Cancer Center in Houston, Texas purchased a MRIdian MR-Guided Radiation Therapy System. This will be the first MRIdian system to be installed at MD Anderson main campus at the Texas Medical Center in Houston, Texas.

06:33 EDT Immunic announces results from Part A, Part B of IMU-856 trial - Immunic announced unblinded safety, tolerability and pharmacokinetic , or PK, results from Part A and Part B of its phase 1 clinical trial of IMU-856 in healthy human subjects. IMU-856 is an orally available and systemically acting small molecule modulator that targets a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. In the SAD part of the phase 1 clinical trial, healthy human subjects were randomized in a double-blinded manner to either placebo or active treatment with single ascending doses of IMU-856 at 10 mg, 20 mg, 40 mg, 80 mg, 120 mg and 160 mg. Single ascending doses of IMU-856 were found to be safe and well-tolerated and no maximum tolerated dose was reached. No serious adverse events occurred. Moreover, a dose-linear PK profile was observed across the investigated dose range. These results allowed a transition to the MAD part of the trial. In the MAD part of this phase 1 clinical trial, healthy human subjects were dosed for 14 consecutive days with 40 mg, 80 mg or 160 mg once-daily of IMU-856 or placebo in a double-blinded manner. Multiple ascending doses of IMU-856 were found to be safe and well-tolerated and no maximum tolerated dose was reached. Treatment emergent adverse events, or TEAEs, were mostly mild in severity. No Investigational Medicinal Product-related serious adverse events were reported. No dose-dependent changes in laboratory parameters, vital signs, physical examination or electrocardiographic evaluations were found. PK analysis showed a quick achievement of stable steady-state plasma concentrations within the first week and stable steady-state trough levels over the 14-day treatment period with a low accumulation factor for IMU-856, allowing predictable trough levels during daily dosing. PK parameters in steady-state revealed a Tmax of two to three hours post-dose, a plasma half-life of 17.4 to 21.5 hours and dose proportional increases in Cmax and AUC. The ongoing Part C of the phase 1 program includes a double-blind, randomized, placebo-controlled trial designed to assess the safety and tolerability of IMU-856 in patients with celiac disease during periods of gluten-free diet and gluten challenge. A total of approximately 42 patients are planned to be enrolled in two consecutive cohorts with 80 mg or 160 mg of IMU-856 given once-daily over 28 days. Secondary objectives include pharmacokinetics as well as acute and chronic disease markers, including those evaluating gastrointestinal architecture and inflammation. Sites in Australia and New Zealand are participating in Part C.

06:19 EDT Infosys enters collaboration with Telenor Norway - Infosys announced its collaboration with Telenor Norway, Telenor's wholly owned Norwegian telecommunications operator, in its business transformation program to become a digital telecommunications company. Through this engagement, Infosys will accelerate Telenor Norway's modernization while supporting its 'Beyond Connectivity' strategy. This collaboration will drive Telenor Norway's business growth and make the company future ready.

06:09 EDT AstraZeneca's Evusheld approved in E.U. for COVID-19 treatment - The company states: "AstraZeneca's Evusheld has been approved in the European Union for the treatment of adults and adolescents with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The approval by the European Commission was based on results from the TACKLE Phase III COVID-19 treatment trial which showed one intramuscular (IM) dose of Evusheld provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo. Evusheld treatment earlier in the disease course led to more favourable outcomes. TACKLE was conducted in non-hospitalised adults with mild-to-moderate COVID-19 who were symptomatic for seven days or less. 90% of trial participants were at high risk of progression to severe COVID-19 due to co-morbidities or age. Evusheld was generally well tolerated in the trial." Reference Link

06:05 EDT Ambow Education CFO KJ Tan resigns - Along with the proposed sale of its operations in China, the company also announced that KJ Tan, Ambow's CFO, has resigned, effective September 19. Jin Huang, president and CEO of Ambow, will serve as acting CFO until a replacement is appointed.

06:04 EDT Ambow receives proposal letter from Clover Wealth to acquire China assets - Ambow Education announced that its board has received a preliminary non-binding proposal letter from Clover Wealth to acquire all of the company's business assets in China. The sale of these assets is in-line with applicable PRC's regulatory requirements introduced in 2021. The proposal letter outlines the SPV's intent to acquire all of the equity interests in WFOEs and VIEs of the Company, and (ii) all of the intellectual properties used in the conduct of business of WFOEs and VIEs and owned by a subsidiary of the company. The purchase price for the target is approximately $10M. The board has begun to carefully evaluate the proposal letter to determine the course of action it believes is in the best interest of the company and its various stakeholders, including plans to engage an independent valuation firm to assess the Target's valuation. AMBO shareholders do not need take any action at this time.

06:02 EDT Mannatech authorizes share repurchase program for up to $1.5M - Mannatech has approved a share repurchase program to acquire up to $1.5M of its outstanding common stock. The timing, volume and nature of share repurchases will be at the discretion of management and dependent on market conditions, applicable securities laws and other factors, and may be suspended or discontinued at any time. This repurchase program begins on September 19, 2022 and ends on the earlier of September 18, 2023 or the purchase of common stock having an aggregate purchase price of $1.5M. Mannatech intends to finance the repurchases with available cash.

05:32 EDT Spirit AeroSystems SEAS joint venture to open in October - Spirit AeroSystems announced at MRO Asia-Pacific in Singapore that Spirit Evergreen Aftermarket Solutions, or SEAS, a joint venture with Evergreen Aviation Technologies, will open for business on October 3 in Taiwan. Spirit announced the joint venture agreement with EGAT in April 2021. The agreement will bring nacelles and flight control surfaces solutions for 777, 747-8, 737, 747/767, 787, A330 and A320.

05:25 EDT Virgin Orbit, Wagner enter MOU to bring national launch capability to Australia - Virgin Orbit announced that it has signed a Memorandum of Understanding, or MOU, with Wagner. The agreement will allow the companies to begin the process of implementing a national launch capability from Australia, with the goal of providing satellite launch services from the Toowoomba Wellcamp Airport using Virgin Orbit's LauncherOne System. Virgin Orbit and Wagner Corporation are exploring the potential to certify Toowoomba Wellcamp Airport as a national spaceport to perform an orbital launch demonstration as early as 2024. The cooperative effort is designed to catalyze the maturing Australian small satellite and space solutions market, stimulate local economic growth, support commercial and civil endeavors and provide Australian defense and government with a flexible, responsive and flight-proven national launch capability in support of a wide range of mission applications.

05:14 EDT Stellantis to raise production of eDCT, open Circular Economy Hub in 2023 - Stellantis announced two additional major initiatives within its Italian industrial footprint aimed at driving the company's global electrification value chain and supporting its decarbonization targets. Stellantis and its joint venture partner, Punch Powertrain, signed a new agreement increasing production of the future-generation electrified dual-clutch transmissions, or eDCT, for Stellantis hybrid and plug-in hybrid electric vehicles, or PHEV. The upgraded facility, developed within the Mirafiori Complex in Turin, Italy, will complement the existing capacity in Metz, France. This builds on the skills the company currently has and is another step in the implementation of the strategic plan for Stellantis' Circular Economy Business Unit as it pushes to quadruple extended life revenues for parts and services and multiply recycling revenues by 10 times by 2030 as compared to 2021. The new Mirafiori e-Transmissions Assembly site is expected to start production in the second half of 2024. At full production, the Mirafiori and Metz, France, facilities together will supply all relevant Stellantis manufacturing sites in Europe. The announcement confirms the global Circular Economy Hub will be launched in 2023 in Mirafiori Complex. The dedicated operation will enable the expansion of Stellantis' current activities and support its 'cradle-to-cradle' business model in Europe. Later announcements will be made that will support Stellantis globally.