Stockwinners Market Radar for October 10, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:23 EDT Cathie Wood's ARK Investment bought 23.6K shares of Adobe today

20:20 EDT Venator Materials closes $51M sale-leaseback transaction - Venator Materials "announced that its U.S. affiliate has closed a sale-leaseback transaction for its Color Pigments manufacturing facility located in Los Angeles, California, with New Mountain Net Lease for $51.3 million. As part of the transaction, Venator entered into an agreement to lease the property from New Mountain for an initial period of 15 years, with an option to extend the lease for two additional terms of approximately 10 years each. The annual lease cost will be $3.4 million in the first year with an initial corresponding capitalization rate of 6.7%."

19:23 EDT Zscaler reports Sinha resigns as President to become CEO at private company - Earlier, Zscaler announced that Amit Sinha has accepted a CEO position at a privately-held technology company and will resign from Zscaler effective October 21. Dr. Sinha will continue his role as a member of the company's board of directors. Functions of R&D, Cloud Operations and Customer Support that reported to Dr. Sinha will now report directly to Jay Chaudhry, Chairman and CEO, the company said. "I'd like to thank Amit for his outstanding contributions to Zscaler over the past 12 years in multiple roles including most recently as President. His technical brilliance and people leadership has helped grow Zscaler into the market leader in cloud security. With strong and talented leaders in R&D, cloud operations and customer support, Zscaler will continue to drive our customer-centric growth strategy and innovate on our cloud platform and offerings. I am pleased that Amit will remain on the Board of Directors of the company as a trusted advisor and strong supporter of Zscaler as we continue to scale our business to our $5 billion ARR target and beyond," said Chaudhry.

17:40 EDT AWS announces general availability of Amazon EC2 Trn1 instances - Amazon Web Services announced the general availability of Amazon Elastic Compute Cloud Trn1 instances powered by AWS-designed Trainium chips. Trn1 instances are purpose built for high-performance training of machine learning models in the cloud while offering up to 50% cost-to-train savings over comparable GPU-based instances. Trn1 instances provide the fastest time to train popular machine learning models on AWS, enabling customers to reduce training times, rapidly iterate on models to improve accuracy, and increase productivity for workloads like natural language processing, speech and image recognition, semantic search, recommendation engines, fraud detection, and forecasting. There are no minimum commitments or upfront fees to use Trn1 instances, and customers pay only for the amount of compute used. "Over the years we have seen machine learning go from a niche technology used by the largest enterprises to a core part of many of our customers' businesses, and we expect machine learning training will rapidly make up a large portion of their compute needs," said David Brown, vice president of Amazon EC2 at AWS. "Building on the success of AWS Inferentia, our high-performance machine learning chip, AWS Trainium is our second-generation machine learning chip purpose built for high-performance training. Trn1 instances powered by AWS Trainium will help our customers reduce their training time from months to days, while being more cost efficient."

17:02 EDT Angi Inc. CEO Oisin Hanrahan steps down, IAC CEO Joey Levin succeeds - Angi (ANGI) announced the appointment of Joey Levin, CEO of IAC (IAC) and chairman of Angi, to CEO of Angi. Oisin Hanrahan has stepped down as CEO and director of Angi. Levin will assume the role of CEO of Angi in addition to his duties as CEO of IAC and will oversee Angi's executive leadership team and daily management of the company. These changes are effective immediately.

16:48 EDT Rigel Pharmaceuticals announces 16% workforce reduction - Rigel announced that it will reduce its workforce by 16%, resulting in the elimination of 30 positions primarily in development and administration. As a result, Rigel expects that it will recognize a one-time cash severance-related charge of approximately $1.5M in the fourth quarter of 2022. This measure is expected to provide reduced operating expenses ranging from $7M-$8M annually, starting in 2023.

16:32 EDT Dycom appoints Jason Lawson Chief Human Resources Officer - Dycom Industries announced the appointment of Jason T. Lawson as Vice President and Chief Human Resources Officer. Mr. Lawson brings more than 25 years of human resources and cross-functional leadership experience to Dycom where he will be responsible for the strategy and direction of HR programs, policies and practices. This includes providing leadership for organizational design and effectiveness, talent acquisition, learning and development, recognition and retention, total rewards and other programs.

16:19 EDT Laser Photonics CEO comments on post-IPO stock performance - Laser Photonics commented on its post-IPO stock performance. The shares began trading on September 30 on the Nasdaq Capital Market under the ticker symbol (LASE) with a float of 3M shares. LPC Management and ICT Investments are subject to a 180-day lockup that prevents them from selling stock, as are other insiders that bought stock as part of the IPO. Wayne Tupuola, chief executive officer of Laser Photonics, commented: "While I can only speculate about the share price performance since pricing the IPO, I know that our fundamentals are solid, with strong revenue growth and profits. I also know the management team did not sell a single share in the IPO and has not sold any shares in subsequent trading. Our IPO provided us with the necessary funding to execute the initial phases of our growth strategy to disrupt the corrosion control market with our line of CleanTech laser cleaning products. I believe the sheer size of the opportunity, the disruptive capability of our current products and those in development, and our ability to execute will create significant shareholder value over time for our current and prospective investors."

16:17 EDT Camden Property estimates $1.0M in expenses related to Hurricane Ian - Camden Property "announced that it expects to incur approximately $1.0 million in expenses during the third quarter of 2022 as a result of Hurricane Ian. These projected expenses relate primarily to cleanup and repairs for water intrusion, roofing, and landscaping at the Company's apartment communities located in Florida and North Carolina. Camden will provide an update to its full-year 2022 earnings guidance in conjunction with its 3Q22 earnings release scheduled for late October 2022."

16:16 EDT XPO Logistics appoints Carl Anderson as chief financial officer - XPO Logistics (XPO) announced the appointment of Carl Anderson as chief financial officer, effective November 8. Anderson will replace Ravi Tulsyan, who will leave the company after assisting with the CFO transition. Anderson most recently served as chief financial officer of Meritor (MTOR).

16:15 EDT Light & Wonder names Matt Wilson CEO - Light & Wonder announced that its Board of Directors has named Matt Wilson as President and Chief Executive Officer and a member of the company's Board of Directors, effective immediately. Wilson has served as interim Chief Executive Officer since August 2022 and previously served as Chief Executive Officer of the company's Gaming business. "The Board of Directors unanimously determined that Matt is the right choice to lead Light & Wonder's next chapter given his impressive track record, extensive industry experience and his pivotal role in transforming our business," said Jamie Odell, Executive Chair of the Light & Wonder Board of Directors. "Matt has demonstrated impressive leadership, strategic vision and a passion for our business. He fully embodies the Light & Wonder culture rooted in embracing innovation, a player-first mentality and a deep commitment to performing and winning as a team. The Board is confident in Matt's ability to unlock the full potential of Light & Wonder as we enter this exciting next chapter." In connection with Wilson's appointment, the Company also announced that Siobhan Lane, Senior Vice President and Chief Commercial Officer of Gaming, has been named the new Chief Executive Officer of Gaming.

16:15 EDT Cohen & Steers reports preliminary AUM $79.2B as of September 30 - A decrease of $10.6B from assets under management at August 31. The decrease was due to market depreciation of $9.2B, net outflows of $1.1B and distributions of $318M.

16:07 EDT Aravive receives $6M development milestone payment from 3D Medicines - Aravive announced that it received a $6M development milestone payment from its licensee, 3D Medicines Inc. This milestone is based on the initiation of the global Phase 3 platinum resistant ovarian cancer, or PROC, clinical trial in China for the development of Aravive's batiraxcept. Aravive's collaboration and license agreement with 3D Medicines Inc. is for the development and commercialization of batiraxcept in oncology indications in Greater China. Under the terms of the agreement, Aravive is eligible to receive up to an aggregate of $207M in development and commercial milestone payments and royalties. In addition to achieving this $6M development milestone, the company had previously received a $9M in development milestones related to development of batiraxcept for platinum resistant ovarian cancer in the United States and China, as well as a $12M upfront payment in 2020, totaling $27M that has been achieved by Aravive from 3D Medicines.

16:07 EDT Floor & Decor launches grand opening of Omaha, NE market - Floor & Decor "opens the doors to its newest location in Omaha, Nebraska on October 17, 2022. The Floor & Decor warehouse store and design center will open with a team of about 50 full-time and part-time associates led by Steve Hatch, the new store's Chief Executive Merchant."

16:06 EDT Kaman selected to build cargo UAS prototype for U.S. Marine Corps. - Kaman Air Vehicles announced that it has been selected to build a logistics UAS prototype for the United States Marine Corps. Kaman will build a funded military version of its KARGO UAV, a purpose-built autonomous medium-lift logistics vehicle. KARGO UAV carries up to 800 pounds of payload and is designed to operate in austere environments. The USMC project is being managed by NAVAIR PMA-263 under the Medium Unmanned Logistics Systems - Air (MULS-A) program. Once the prototype is constructed, KARGO UAV will complete a Field User Capability Assessment conducted in an operationally relevant test environment. Kaman began development of its KARGO UAV last year and flew a scaled demonstrator in Fall of 2021 to prove out the concept. A full-scale demonstrator is under construction, and first flight is scheduled for later this year. Near Earth Autonomy, from Pittsburgh, PA was selected as the autonomy provider on KARGO UAV, and parallel testing is ongoing for the autonomy systems that will be employed on the Marine Corps prototype.

15:47 EDT Carvana launches co-signer financing in Baltimore - Carvana is now offering Baltimore residents the ability to add a co-signer to buy a vehicle. By sharing responsibility for the vehicle loan, Carvana customers in Baltimore who qualify may unlock more attractive financing offers, including lower down payments, lower interest rates, or lower monthly payments.

15:27 EDT Carvana launches co-signer financing in Wilmington, Delaware - Carvana said it is now offering Wilmington, Delaware residents the ability to add a co-signer to buy a vehicle. "Adding a co-signer couldn't be easier," the company said. "Customers can simply apply alongside their co-signer and include the co-signer's information on Carvana's website or app. Customers will see their financing terms-both with and without their co-signer-in a matter of seconds with no impact to either individual's credit score. If eligible customers want to move forward with a co-signer, Carvana collects driver's licenses and other documents from both individuals and schedules a delivery where both individuals must be present to check out the new ride."

15:05 EDT VPX Sports, maker of Bang Energy drinks, seeks Chapter 11 bankruptcy protection - Vital Pharmaceuticals, or "VPX Sports," along with certain of its domestic subsidiaries and affiliates, announced it has filed voluntary petitions for protection under Chapter 11 of the Bankruptcy Code in the Southern District of Florida. "VPX Sports is the maker of Bang energy drinks, among other consumer products. All business operations will continue, with improved product delivery and service to retailers through VPX/Bang Energy's newly constituted legacy distribution network consisting of more than 269 best-in-class distributors. VPX's Chapter 11 efforts are being supported by $100 million of additional financing from VPX's esteemed syndicate lenders to help ensure operations continue uninterrupted during the restructuring process," the company stated. "VPX/Bang Energy intends to reclaim the formidable market share that dwindled while Pepsi was the national distributor of Bang energy drink products. Immediately prior to VPX/Bang Energy switching to Pepsi in early 2020, Bang's share of the energy drink market was roughly 9.7%. Under Pepsi's distribution, roughly 3.4% of that market share was lost. At $200 million per share point, that equates to $680 million in today's energy drink market. Bang Energy's newly orchestrated and soon-to-launch direct store distribution network currently covers nearly 95% of the entire United States market," the company added. Bang Energy competes with products marketed by Monster Beverage (MNST), Coca-Cola (KO) and PepsiCo (PEP).

13:24 EDT Genius Sports says litigation with Sportradar resolved - Genius Sports (GENI) issued the following statement regarding a settlement of litigation with Sportradar (SRAD): "The litigation has been resolved. The resolution enables FDC to continue to license and market FDC data, in future as it determines. Genius Sports shall maintain the exclusive right to provide low latency Official FDC betting data rights through 2024. Sportradar has agreed to refrain from unofficial in-stadia scouting of Premier League, Football League, and Scottish Professional Football League matches, and has purchased a sublicense from Genius Sports for a delayed feed to be marketed as the Official FDC Secondary Feed, through 2024. The remaining terms of the settlement are confidential."

13:04 EDT Leonardo DRS awarded $579M contract for advanced thermal weapon sights - Leonardo DRS announced that it has received a contract to produce its next-generation thermal weapon sights for the U.S. Army. The firm-fixed-price contract from the U.S. Army Contracting Command is valued at $579M over five years. The contract was originally awarded on April 28, 2022. On June 21, 2022, DRS and RADA Electronic (RADA) announced an all-stock merger transaction. Upon completion, RADA will become a wholly-owned subsidiary of DRS and the combined company plans to be listed on Nasdaq and on the TASE under the ticker symbol "DRS".

13:01 EDT RADA Electronic trading halted, volatility trading pause

12:39 EDT Denbury up 6% to $98.14 after Bloomberg says Exxon weighs buyout

12:32 EDT Digital World Acquisition announces further adjournment of Special Meeting - Digital World Acquisition announced that it is further adjourning its special meeting of stockholders from October 10, 2022 to 10:00 a.m. Eastern Time on November 3, 2022. The Special Meeting, which was originally scheduled for September 6, 2022, is being further adjourned in order to solicit more votes toward the approval to further amend the Company's amended and restated certificate of incorporation to extend the period of time available to complete a business combination up to four times, each by an additional three months, for an aggregate of 12 additional months or such earlier date as determined by the Company's Board of Directors. The Extension Amendment would effectively provide for an additional six months, past the two three-month extensions currently permitted by the Company's existing governing documents, to complete a business combination. The Company plans to continue to solicit proxies for the Special Meeting until November 3, 2022.

12:28 EDT Johnson & Johnson announces data from long-term extension Stelara trial - Janssen Pharmaceutical of Johnson & Johnson announced final data from the long-term extension of the Phase 3 UNIFI study demonstrating efficacy and safety of Stelara through four years of treatment in adult patients with moderately to severely active ulcerative colitis. Among all patients who had achieved clinical response with Stelara during induction, 64.9% were in symptomatic remission after 44 weeks of maintenance. At week 200, this proportion of patients was 55.2%, the majority were not receiving corticosteroids. Among the 174 patients receiving Stelara as their first biologic for ulcerative colitis, 71.8$% of these patients were in symptomatic remission after 44 weeks of maintenance, and 67.2% were in remission at week 200. Reference Link

12:00 EDT TAL Education falls -11.9% - TAL Education is down -11.9%, or -59c to $4.41.

12:00 EDT Veris Residential rises 11.4% - Veris Residential is up 11.4%, or $1.18 to $11.55.

12:00 EDT HCI Group rises 14.0% - HCI Group is up 14.0%, or $4.66 to $37.91.

11:33 EDT Xerox appoints Fred Beljaars as EVP, chief delivery, supply chain offic - Xerox Holdings announced it has appointed Fred Beljaars as Executive Vice President and Chief Delivery and Supply Chain Officer. Beljaars assumes the position following the departure of Mary McHugh earlier this month. In this newly expanded role, Beljaars is responsible for leading all delivery, manufacturing, supply chain, and procurement operations globally and will focus on continuing to transform these missions to become more client-centric and strategic drivers for Xerox's success. Beljaars first joined Xerox in 2018 as Chief Supply Chain Officer and led the global supply chain, procurement, and real estate functions.

11:01 EDT BAE Systems to provide electric drive solutions for ENC's next-gen buses - BAE Systems announced it will provide ElDorado National, or ENC, a subsidiary of REV Group, with its Gen3 product line solutions for ENC's next-generation battery-electric and hydrogen fuel cell transit buses under a long-term supply agreement. "BAE Systems and ENC have worked together for years to help cities improve air quality with electric bus solutions. Our expanded collaboration now includes multiple zero-emission options, delivering efficient, proven, and clean transportation solutions for transit fleets," said Steve Trichka, vice president and general manager of Power & Propulsion Solutions at BAE Systems.

10:48 EDT TYRA Biosciences trading halted, volatility trading pause

10:19 EDT Perficient enters multiyear agreement with Dallas Mavericks - Perficient announced a multi-year expansion of its partnership with the Dallas Mavericks NBA franchise. Under terms of the agreement, Perficient will receive a variety of marketing and corporate engagement benefits, including courtside and digital signage and client hospitality amenities. Perficient will also continue as the exclusive sponsor of the Honorary Co-Captain program, in which young Mavericks fans receive an exclusive, on-court pre-game experience.

10:00 EDT Credit Suisse falls -7.0% - Credit Suisse is down -7.0%, or -34c to $4.51.

10:00 EDT New Oriental Education falls -7.9% - New Oriental Education is down -7.9%, or -$2.00 to $23.48.

10:00 EDT Direxion Daily Semiconductor Bear 3X Shares rises 7.3% - Direxion Daily Semiconductor Bear 3X Shares is up 7.3%, or $4.63 to $67.84.

09:51 EDT Martin Midstream Partners sells Stockton Sulfur Terminal to Gulf Terminals - Martin Midstream Partners announced the sale of its Stockton Sulfur Terminal to Gulf Terminals. The net proceeds of approximately $5.25M will be used to reduce outstanding borrowings under the partnership's revolving credit facility.

09:47 EDT Credit Suisse falls -6.6% - Credit Suisse is down -6.6%, or -32c to $4.53.

09:47 EDT Itau Corpbanca rises 5.7% - Itau Corpbanca is up 5.7%, or 17c to $3.14.

09:47 EDT Toast rises 7.0% - Toast is up 7.0%, or $1.17 to $17.99.

09:41 EDT AMV Stock trading resumes

09:39 EDT UMH Properties says damage was 'minimal' from Hurricane Ian - UMH Properties reported on the impact of Hurricane Ian on its manufactured housing community, owned through its joint venture with Nuveen Real Estate, located in Sebring, Florida. Samuel Landy, President and CEO, commented, "We are proud to report that Sebring Square and our modern manufactured homes performed exceptionally well through a devastating storm. The community experienced a direct hit from the storm with sustained winds of over 75 miles per hour with gusts much stronger and over 10 inches of rain. We had a hurricane preparedness plan in place and emergency supplies on site. Fortunately, none of our residents or employees were injured. Several of our homes had minor roof and skirting damage, 4 sheds were destroyed, and a few palm trees were uprooted. The limited damage to our homes and our community demonstrates the quality and durability of our homes. While our damage was minimal, others were not as fortunate and faced significant damage. We have homes available and are working to provide housing to those who have been displaced. UMH is discussing with federal, state, and local officials the assistance UMH can provide for the current housing emergency. UMH will accelerate, if possible, the development of new homes in Florida to address this urgent housing need."

09:32 EDT Correction: Nutanix did not announce U.S. expansion - The incorrect story at 5:04 AM today has been removed.

09:30 EDT Singing Machine announces updates to subscription karaoke app - The Singing Machine Company announced new updates to its integrated WiFi streaming karaoke app and mobile iOS and Android karaoke music subscription apps. Starting this month, the Company's suite of subscription-based karaoke music apps will begin to include official artist album cover art, viewable within the App. The latest update provides access to highly recognized and often-iconic album cover artwork that has become synonymous with chart-topping hits of the original artist. The new addition of album art comes with recent additions to the karaoke catalog which has grown to over 70,000+ songs, including new additions from AC/DC, Megan Thee Stallion, Billie Eilish, and many more.

09:29 EDT Biogen announces first patient dosed in Phase 2/3 AMETHYST study - Biogen announced that the first patient has been dosed in the global clinical study, AMETHYST. The Phase 2/3 study will evaluate the clinical efficacy and assess the safety of litifilimab, also known as BIIB059, a first in-class, humanized IgG1 monoclonal antibody, or mAb, targeting blood dendritic cell antigen 2, as compared to placebo, in participants with cutaneous lupus erythematosus, or CLE. AMETHYST is expected to be conducted at approximately 238 sites worldwide and aims to enroll 474 adults with CLE, the company noted. The Phase 2 and Phase 3 parts of the study will each be 52 weeks in duration. Participants will be randomized to receive subcutaneous treatment with litifilimab or placebo every four weeks for 20 weeks with an additional loading dose at Week 2. All participants will receive litifilimab during the 28-week extended treatment period from Weeks 24 to 48. The primary endpoint will assess the effect of litifilimab on skin disease activity, compared to placebo.

09:16 EDT Imperial Petroleum announces delivery of Japanese built dry bulk carrier - On September 21, 2022 it took delivery of a 2011 Japanese built dry bulk carrier the Eco Bushfire for a consideration of $20.5 million. The Company also announces the closing and drawdown by two of its product tanker ship owning subsidiaries of a new $17.0 million term loan facility. This facility will be repayable in sixteen consecutive quarterly installments of $0.55 million each and a balloon installment of $8.2 million payable concurrent with the 16th repayment installment on the final maturity date. The facility will be guaranteed by the Company and secured with first priority ship mortgages over its vessels Clean Justice and Clean Nirvana In addition to the aforementioned facility, the Company has also entered into a commitment letter for a senior secured credit facility in an amount of up to $30.8 million related to the financing of the two crude tanker vessels, the Suez Protopia and the Suez Enchanted, which will collateralize the facility. This facility remains subject to the conclusion and execution of final documentation.

09:08 EDT American Airlines makes equity investment in Universal Hydrogen - American Airlines (AAL) announced its strategic equity investment in Universal Hydrogen, a company building a green hydrogen distribution and logistics network for aviation. The investment supports American's science based targets to reduce greenhouse gas GHG emissions by 2035, and ultimately its commitment to achieve net zero GHG emissions by 2050. This investment makes American the first U.S. airline to make two direct investments focused on the development of both hydrogen-electric propulsion technology and the future of hydrogen distribution logistics. Universal Hydrogen's fuel distribution network uses modular hydrogen capsules that are handled like cargo, eliminating the need for new fueling infrastructure at airports and speeding up fuel loading operations..."This technology has the potential to be a game-changer on the industry's path to zero-emission flight," said American's Chief Financial Officer Derek Kerr. "As the world's largest airline, American has a responsibility to exercise leadership in making aviation sustainable. Our investment in Universal Hydrogen represents a vote of confidence for green hydrogen as a key element of a sustainable future for our industry." American joins Airbus Ventures (EADSY), GE Aviation (GE) and Toyota Ventures (TM), as well as several major hydrogen producers and aircraft lessors, as strategic investors in Universal Hydrogen.

09:07 EDT Cumulus Media launches 810 THE SPREAD sports betting station - Cumulus Media announces that it has launched the Bay Area's first Sports radio station focused on sports betting, 810 THE SPREAD. The new station brings sports and sports betting news, information, and insights to the burgeoning and underserved sports betting audience in San Francisco. 810 THE SPREAD will deliver behind-the-book perspectives from experts in a highly entertaining and engaging format. 810 THE SPREAD goes live today on the legendary 810am frequency that has been the 80-year home of historic Talk Radio KGO-AM. Cumulus San Francisco also launched the station's new website at www.810thespread.com. Kevin Graham, Program Director of Cumulus' sister sports stations KNBR 680AM/104.5FM and 1050 KTCT, adds Program Director duties for 810 THE SPREAD.

09:04 EDT JX Luxventure changes ticker symbol to 'JXJT' starting October 10 - JX Luxventure announced that it changed its trading symbol from "LLL" to "JXJT," and that at the opening of the market on October 10, the company's common stock began trading on the Nasdaq Capital Market under the company's new trading symbol, "JXJT."

09:04 EDT TOP Ships announces compliance with NASDAQ minimum bid price requirement - TOP Ships announced that NASDAQ notified the Company that it has regained compliance with the minimum bid price requirement for the Nasdaq Capital Market, set forth in Nasdaq Listing Rule 5550(a)(2).

08:56 EDT PPG drops 6% to $107.00 after lowering Q3 EPS outlook

08:47 EDT IES Holdings divests STR Mechanical to SkyKnight Capital affiliate - IES Holdings announced that it has sold STR Mechanical and its subsidiary Technical Services II to an affiliate of SkyKnight Capital. STR, originally acquired by IES in 2016, is a Charlotte, North Carolina-based provider of heating, ventilation and air conditioning maintenance, repair, and replacement services to commercial customers and had operated as part of IES's Commercial & Industrial segment.

08:43 EDT Rapid Micro Biosystems announces new product RMBNucleus Mold Alarm - Rapid Micro Biosystems announced its newest product, RMBNucleus Mold Alarm, which is designed to rapidly detect environmental molds in the pharmaceutical manufacturing process. RMBNucleus Mold Alarm is expected to be available on the Growth Direct System before the end of 2022. Slow detection and confirmation of mold contamination continues to be a critical challenge within environmental monitoring at pharmaceutical manufacturing facilities and can compromise products, putting patients at risk. RMBNucleus Mold Alarm, a new software offering for use on the Growth Direct System, adds rapid detection allowing for early intervention. "RMB is committed to supporting life-saving therapies, one patient at a time," said Rob Spignesi, President and CEO of Rapid Micro Biosystems. "We are excited to introduce RMBNucleus Mold Alarm, which will enable our Growth Direct System to rapidly detect environmental molds in the pharmaceutical manufacturing process. As with each of our products on the Growth Direct System, RMBNucleus Mold Alarm comes with enhanced data integrity and generates automated alerts at the first sign of mold detection in as little as one day, allowing for early intervention and reduced risk of contamination."

08:41 EDT Tomi to install custom engineered iHP System in Avid Bioservices facility - TOMI Environmental Solutions (TOMZ) announced that it has recently received a purchase order for an iHP Custom Engineered System from Avid Bioservices (CDMO) for implementation in Avid's new purpose-built viral vector development and manufacturing facility in Costa Mesa, California. During site development, a SteraMist iHP Custom Engineered System will be implemented within four GMP manufacturing suites. This will require eleven applicators with a single control panel and a 55-gallon BIT solution container. Earlier this month, the TOMI team began working with Avid's team on planning the installation, which is projected to be finalized in the first half of 2023.

08:40 EDT Tenax Therapeutics announces presentation of data from study of levosimendan - Tenax Therapeuti announces the presentation of positive data from a study of PH-HFpEF patients being treated with oral levosimendan. The data, collected during the transition from intravenous to oral levosimendan in the open-label extension, OLE, of the HELP trial, were presented at the Heart Failure Society of America, HFSA, Scientific Sessions 2022, held from October 1 -3, 2022. Title: "The Transition from Chronic Intravenous to Oral Levosimendan Is Safe and Effective in Patients with Pulmonary Hypertension with Heart Failure and Preserved Ejection Fraction" This substudy of 18 PH-HFpEF patients who transitioned from IV to oral levosimendan, included an evaluation of safety and efficacy across several measures. As compared with the patient's baseline, the mean change in resting heart rate was 4.9 beats/min, the mean systolic arterial blood pressure was 4.1 mm Hg, the mean change in 6-minute walk distance was 13.1 meters, BNP was -133.3 pg/dl, and NT-proBNP was -239.4 pg/dl. The mean Kansas City Cardiomyopathy Questionnaire scores improved by 4.7, 2.5 points and 3.7 points, respectively. The authors concluded that the levosimendan oral formulation was well tolerated without safety concerns over a 6-8-week period in patients with PH-HFpEF who received IV levosimendan for an average of 18 months. There were no serious adverse events related to oral levosimendan therapy. Oral levosimendan was associated with further numerical improvements in 6MWD, BNP/NT-ProBNP, and all key KCCQ domains, suggesting oral levosimendan at 3-4 mg/day may provide a superior formulation for chronic use in PH-HFpEF patients when compared to the intravenous administration of levosimendan.

08:39 EDT Minim participates in first Amazon Prime Early Access sale - Minim announces its full list of promotions on its collection of home networking devices that will be available to Prime members during the inaugural Prime Early Access sales event from October 11 - October 12. During the pre-holiday sales event, the company will offer shoppers discounts on its mesh systems, as well as its gateways and cable modems from the Motorola networking portfolio, which holds the top market share of category sales on the Amazon Marketplace. During the 48-hour sale, Prime members will have the opportunity to upgrade the security and performance of their home networks just in time for the holiday shopping rush, as all Motorola-branded home networking devices support the motosync app powered by Minim. This intuitive network management software is an excellent solution to keep users' personal information safe, thanks to sophisticated security measures, such as malware monitoring, ad-blocking, parental controls and much more. Additionally, access to in-app chat support places home networking experts at users' fingertips, offering a direct connection to our team of troubleshooters in under a minute.

08:38 EDT Bebuzee announces Shopping Buz on Bebuzee Super App - Bebuzee has completed a global e-commerce platform called Shopping Buz on Bebuzee Super App. The company said, " Shopping Buz is a unique technology driven e-commerce platform, which gives merchants incredible tools to sell their products. Shopping Buz is packed with functionality like never before seen on an e-commerce platform. Details are currently under wraps as the Company prepares to unveil the Western Hemisphere's First-to-Market SuperApp, following in the steps of companies in Asia, and others who see trillions of dollars in transactions pass through the apps."

08:36 EDT ToughBuilt announces Q3 Amazon sales $3.91M - ToughBuilt Industries announced that gross sales for Q3 2022 through Amazon.com were $3.91M. This represents a 28% rise from the same quarter in 2021. Sales for the 9-month period ending on September 30, 2022, increased by 24% to approximately $10.92M, compared to $8.3M for the same period in 2021.

08:35 EDT Supernus says FDA requires additional information, analysis for SPN-830 NDA - Supernus Pharmaceuticals announced that the U.S. Food and Drug Administration has issued a Complete Response Letter for the SPN-830 New Drug Application. SPN-830 is an investigational apomorphine infusion device under review for the continuous treatment of motor fluctuations in Parkinson's disease. The CRL requires additional information and analysis related to the infusion device and drug product across several areas of the NDA including, but not limited to, labeling, product quality and manufacturing, device performance and risk analysis. In addition, the FDA mentions that approval of the NDA requires inspections that could not be completed in a timely manner due to COVID-19 travel restrictions. The CRL does not request additional efficacy and safety clinical studies. Supernus will continue to work closely with the FDA to address all questions, and when possible, to provide clarity regarding the potential timing of a resubmission of the NDA. The FDA has made an initial determination that the amendment to the Company's application in response to the CRL will be subject to a Class 2, or six-month, review timeline.

08:26 EDT Amazon to invest over EUR 1B to electrify European transportation network - In a Sunday blog post, the About Amazon Team said, "Amazon announced plans to invest more than EUR 1 billion over the next five years to further electrify and decarbonize its transportation network across Europe, delivering packages to customers more sustainably. The investment is also intended to drive innovation across the industry and encourage more public charging infrastructure, which will help enable the broader transportation industry to more quickly reduce emissions. The company is already using thousands of zero-emission vehicles across its European operations, and this investment will add thousands more, accelerating Amazon's progress toward becoming net-zero carbon by 2040-10 years ahead of the Paris Agreement...Amazon has more than 3,000 electric vans delivering packages to customers across Europe and, with the investment announced today, expects to grow its fleet to more than 10,000 by 2025. Amazon has launched micro-mobility hubs in more than 20 cities across Europe, including London, Munich and Paris, and expects to double that figure by the end of 2025. Micro-mobility hubs are smaller, centrally-located delivery stations. In Europe's traditionally dense cities, the hubs enable Amazon to operate new delivery methods, such as e-cargo bikes and on-foot deliveries, to bring packages to customers more sustainably. Micro-mobility hubs take traditional delivery vans off the road, which alleviates traffic congestion in city centres and improves air quality. In addition to these new vans and micro-mobility hubs and vehicles, Amazon will also invest in thousands of chargers across its European facilities. The investment will allow the company and its partners to improve fleet charging hardware...Long haul transportation is a hard-to-decarbonize sector due to the size and weight of the trucks and trailers, and the long distances they need to travel. Electric heavy goods vehicles are a promising technology, but eHGV production and charging infrastructure availability are limited. Amazon today has five eHGVs on the road in the UK, and will have 20 on the road in Germany by the end of this year. Amazon is using its size and scale to help spark the scaling of eHGV production so Amazon and others can more quickly transition away from diesel trucks. With the investment announced today, Amazon expects to purchase and roll out more than 1,500 eHGVs in its European fleet in the coming years. To power its eHGVs, Amazon will build hundreds of specialized fast chargers across its European facilities, allowing the company to charge the vehicles in approximately two hours." Reference Link

08:18 EDT WisdomTree reports monthly metrics for September - WisdomTree Investments released monthly metrics for September 2022, including assets under management and flow data by asset class. Key Highlights: Approximately $1.75 billion of Q3 2022 inflows extends WisdomTree's inflow streak to 8 consecutive quarters; Achieved approximately 12% total annualized inflow rate in 2022, with year-to-date inflows in 7 of WisdomTree's 8 primary asset categories; U.S. Equity products are inflowing at a 13% annualized rate in 2022 year-to-date; WisdomTree achieved key milestone toward blockchain enabled financial products and services with SEC approval of WisdomTree Short-Term Treasury Digital Fund.

08:16 EDT XS Financial receives $10M from delayed drawdown of convertible notes - XS Financial Inc. (XSHLF) announces receipt of its delayed draw of $10 million. The aggregate principal amount of the unsecured convertible notes financing was $43.5 million, of which $33.5 million was funded at closing on November 1, 2021. The financing was led by a large institutional investor, with additional participation from strategic partners including, urban-gro (UGRO), Landrace Financial, Bengal Capital, and KEY Investment Partners.

08:15 EDT scPharmaceuticals announces $100M debt financing agreement - scPharmaceuticals announced that the company has entered into a binding term sheet with respect to a $100 million secured debt facility with funds managed by Oaktree Capital Management, L.P. The potential transaction is subject to the parties' execution of definitive agreements and customary closing conditions to be stipulated therein. The definitive agreements are expected to be signed by mid-October. Cowen acted as exclusive financial advisor to scPharmaceuticals on this transaction. scPharmaceuticals plans to use these available funds, together with cash on-hand, to repay indebtedness under its existing loan and security agreement and to execute on the launch of FUROSCIX, which received marketing approval from the U.S. Food and Drug Administration on October 7, 2022. Per the terms of the binding term sheet, Oaktree is expected to provide scPharmaceuticals with $50 million immediately upon signing of the definitive agreements. The remaining $50 million would be made available in two additional $25 million tranches based upon the achievement of pre-specified commercial milestones. The debt facility is expected to carry an interest rate equal to the three month secured overnight financing rate plus 8.75%, with the interest rate capped at 11.75% per annum. Following the achievement of $100 million in trailing twelve-month U.S. net sales of FUROSCIX, the interest rate margin will be lowered to 8.25%. The debt facility is expected to mature five years from funding and carry a 36 month interest-only period.

08:14 EDT Procept BioRobotics announces $52M debt refinancing - PROCEPT BioRobotics announced that it has entered into a new five-year $52 million loan arrangement with CIBC Innovation Banking. Proceeds from the new term loan were used to retire a $50 million debt facility with the Company's existing lender. The Company's new term loan includes a final maturity date of five years from the closing date. The new term loan has an interest-only period of 36 months, which may be extended to 48 months.

08:13 EDT Bragg Gaming enters license agreement with Sega Sammy Creation - Bragg Gaming announced that it has entered into a licensing agreement with Sega Sammy Creation, or SSC, a provider of slot games for land-based casino slots, pursuant to which Bragg has exclusive rights to distribute select titles from SSC's popular content portfolio to iGaming operators in the USA, U.K. and other global markets. The partnership between Bragg and SSC furthers the company's content-led strategy, bringing to Bragg's partner lineup a new content provider in the North American market. Under the terms of the exclusive licensing agreement, Bragg will license select SSC titles, adapting the games for the North America, European and other regulated online gaming markets. All titles developed using SSC's intellectual property will join the "powered by Bragg" library of exclusive slot titles from its partner studios.

08:12 EDT Silo Pharma initiates toxicity study of ketamine formulation - Silo Pharma announced that it has initiated a preclinical toxicity study of its novel time-released, dosage controlled formulation of ketamine, designated as SP-26, for the treatment of fibromyalgia. In the safety evaluation study, the tolerability of the SP-26 compound will be determined in a mini pig study using an ascending dosing regimen. Data from the study is expected in the first quarter of 2023. Silo Pharma recently announced that it is working with a regulatory partner to prepare an FDA Pre-Investigational New Drug package for SP-26. The Company intends to pursue a 505(b)(2) regulatory pathway for the drug candidate.

08:08 EDT Chemours in JV with BWT to facility transportation fuel cell market - The Chemours Company announced plans to enter into a joint venture with BWT FUMATECH Mobility GmbH, an established player in multiple hydrogen markets, focused on membrane manufacturing in the field of fuel cell technology. Completion of the transaction is subject to customary regulatory approvals. The joint venture-THE Mobility F.C. Membranes Company GmbH-is rooted in both companies' understanding of the critical role heavy-duty fuel cell membranes play in driving the global hydrogen economy. Through this partnership, Chemours and BWT will integrate their complementary capabilities, resources, and technological expertise-as well as more than 85 years of combined experience in fuel cell membrane innovation-to expedite supply to original equipment manufacturers and to ensure growing demand is met in the near and long terms.

08:07 EDT Dare announces IDE approval for single arm contraceptive study of Ovaprene - Dare Bioscience announced that the U.S. Food & Drug Administration, FDA, approved an Investigational Device Exemption, IDE, application allowing Dare to conduct a single arm, open-label pivotal contraceptive efficacy study of Ovaprene, an investigational hormone-free monthly intravaginal contraceptive. The IDE approval reflects that the FDA determined the Company provided sufficient data to support the initiation and conduct of the study. The IDE submission included the results of the postcoital test, PCT, clinical study of Ovaprene, in which Ovaprene prevented essentially all sperm from entering the cervical canal across all women and all cycles evaluated. PCT clinical trials have been used as a surrogate marker for contraceptive effectiveness. In order for the planned study to serve as the primary clinical support for a future marketing approval or clearance, the FDA provided additional study design considerations with the IDE approval letter. "The FDA communication," Sabrina Martucci Johnson, President & CEO of Dare Bioscience said, "confirms our alignment on a number of key aspects of the clinical study, including the adequacy of a 12-month duration. The additional study design considerations provided by the FDA are considered by the FDA to be recommendations that do not need to be addressed in order for us to initiate and conduct this study. However, implementing the guidance that we received from the FDA will further position this pivotal study to collect safety and effectiveness data that will support the submission of a Premarket Approval application. Therefore, we look forward to working with our collaborators at the NIH and at Bayer to review and implement the recommendations and we are targeting mid-year 2023 study recruitment initiation." The multi-center, single arm, non-comparative, pivotal Phase 3 contraceptive study of Ovaprene will evaluate its effectiveness as a contraceptive device along with its safety and usability. If successful, Dare expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries. If Ovaprene is approved by the FDA, it could be the first monthly non-hormonal contraceptive product for women and a first-in-category option for women seeking a hormone-free, self-administered and monthly birth control method.

08:05 EDT Opera: 360 shareholders vote 'yes' on repurchase agreement with Opera - Opera announced that the shareholders of 360 Security Technology have approved the previously announced share repurchase agreement between Opera and its pre-IPO shareholder Qifei International Development Co. Ltd., a 360 subsidiary. Following the transaction, 360 will no longer be a shareholder in Opera. Opera will update the market once the transaction is closed, which is expected to take place within 10 business days.

08:04 EDT Morphic presents new MORF-057 Phase 1 data at UEG week 2022 - Morphic Therapeutic announced the presentation of new phase 1 data from MORF-057 phase 1 studies at the United European Gastroenterology, UEG, Week 2022. These new data describe a 200 mg BID MORF-057 dose cohort and build upon the previously reported safety and pharmacodynamic data from the MORF-057-101 study. MORF-057 is being developed as an oral alpha4beta7 inhibitor candidate for the treatment of inflammatory bowel disease, IBD, with an initial focus in ulcerative colitis, UC. "The MORF-057 data presented at UEG Week 2022 reinforce data from previous studies indicating that MORF-057 drives activity consistent with vedolizumab, the biologic alpha4beta7 inhibitor approved the treatment of ulcerative colitis. These new UEG data demonstrate saturating alpha4beta7 receptor occupancy at the 200 mg BID dose and statistically significant changes in key lymphocyte subsets," commented Bruce Rogers, PhD, President of Morphic. "We believe that these data strongly underpin the EMERALD studies in ulcerative colitis, including the ongoing open-label phase 2a study of MORF-057, and may provide additional understanding of the dose-related activity of MORF-057 to be evaluated in the upcoming EMERALD-2 global randomized controlled phase 2b trial."

08:04 EDT iRadimed withdraws 510(k) application for MR IV pump - IRADIMED CORPORATION announced that the Company voluntarily withdrew its 510(K) application on October 5, 2022, for its next-generation MR IV pump. Roger Susi, President and CEO of the Company, commented, "We have been engaged in several productive and positive discussions with the FDA. The FDA requested additional information that was not feasible to provide within FDA's review deadline; therefore, we decided to withdraw our application to provide us more time to understand and resolve the FDA's concerns. We are confident that after working with the FDA, we will be able to submit a 510(k) application that leads to a timely clearance for the MRidium 3870 Infusion Pump System. It is important to note that this withdrawn 510(k) is for a future product and in no way affects our current revenue-generating product portfolio."

08:03 EDT Elys Game Technology announces partnership with Bookmakers - Elys Game Technology announced a partnership with Bookmakers to provide land-based sportsbook services within the Top Hat Sports Bar & Grill, located in Parkville, Maryland. Under the agreement, Elys will receive a percentage of all sports betting revenue generated pending final regulatory approval of the Maryland Lottery and Gaming Control Commission. Michele Ciavarella, Executive Chairman of Elys Game Technology, stated, "We are pleased to enter this partnership with Bookmakers, LLC to provide them with an end-to-end, best-in-class sportsbook solution for their customers. Top Hat Sports Bar & Grill, Parkville's premier pool hall for over three decades, includes a sports bar and lounge area with multiple flat screen TVs for viewing your favorite sports, making it an ideal location to include our sportsbook solution for their customers. We look forward to working with Karen Senac and the Bookmakers team to fulfil their inaugural sportsbook goals."

08:02 EDT scPharmaceuticals announces FDA approval of FUROSCIX - scPharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has approved FUROSCIX, a proprietary formulation of furosemide delivered via an On-Body Infusor for the treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure. FUROSCIX is not indicated for emergency situations or in patients with acute pulmonary edema. FUROSCIX Infusor will deliver only an 80-mg dose. FUROSCIX is the first and only FDA-approved subcutaneous loop diuretic that delivers IV equivalent diuresis at home via the FUROSCIX Infusor. "Congestion due to worsening heart failure is one of the most common causes of hospital admissions in patients over 65, and today's approval of FUROSCIX represents an important treatment advancement for the over seven million heart failure patients in the U.S. that will be able to self-administer IV equivalent diuresis at home," said John Tucker, President and Chief Executive Officer of scPharmaceuticals. "We are preparing to optimize commercialization efforts to offer FUROSCIX to patients in the first quarter of next year with the goal of driving rapid patient adoption to meet the needs of the $5.9 billion addressable market in the U.S."

07:47 EDT Immatics reports interim clinical data update on ACTengine IMA203 - Immatics announced a clinical data update for the IMA203 monotherapy covering the completed Phase 1a dose escalation part of the trial and initial data from the first 5 patients in the ongoing Phase 1b dose expansion cohort A. In the Phase 1 trial with ACTengine IMA203, Immatics is treating recurrent and/or refractory solid cancer patients utilizing TCR-T cells directed against an HLA-A*02-presented peptide derived from PRAME, which is frequently expressed across several solid cancer indications. Overall, IMA203 continues to be well tolerated and achieved confirmed objective responses across multiple solid cancers such as cutaneous melanoma, ovarian cancer, head and neck cancer, uveal melanoma, and synovial sarcoma. Encouraging early signs of improved durability were seen with a 50% confirmed objective response rate, when patients were infused at the target dose or above with more than 1 billion TCR-T cells. The data obtained during the Phase 1a and Phase 1b cohort A trial provide clinical validation of PRAME as a highly promising T cell target for solid cancers. Confirmed clinical responses were observed at high and low PRAME-expression levels above threshold, indicating IMA203's potential to provide clinical benefit for all PRAME biomarker-positive cancer patients. The predicted high PRAME prevalence across key indications has so far been supported by prevalence rates obtained during the clinical screening of patients. Moving from Phase 1a to Phase 1b, Immatics has continued to introduce planned improvements that may influence clinical outcomes including applying higher cell doses, optimizing the cell product through manufacturing enhancements and working with disease area experts to gradually reduce the fraction of very heavily pre-treated patients with extreme tumor burden who have exhausted standard of care and have undergone multiple clinical trials. In addition, the focus in Phase 1b is also shifting from initial objective response rate determined at the ~6-week scan to confirmed ORR determined at the ~12-week scan. Positively evolving durability profile for IMA203 was observed at higher doses: 6 of 12 patients treated with more than 1 billion infused TCR-T cells in the Phase 1a and Phase 1b cohort A part of the trial experienced a confirmed objective response. In the Phase 1b part of the trial alone, 4 of 5 patients had a confirmed objective response which were all ongoing at the timepoint of data cut-off. Safety data for IMA203 monotherapy across Phase 1a and Phase 1b: Treatment with IMA203 continues to show manageable tolerability profile. At data cut-off on September 6, 2022, 32 patients were infused with IMA203 TCR-T cells. Most frequent treatment-emergent adverse events were as expected for cell therapies. All patients experienced expected cytopenia associated with lymphodepletion. 31 patients experienced cytokine release syndrome of any grade: 29 patients had low to moderate, and 2 patients had Grade 3 CRS that occurred in Phase 1a; both recovered to Grade less than or equal to2 after 3 and 4 days. 5 patients experienced a low to moderate immune effector cell associated neurotoxicity syndrome. No dose-dependent increase of CRS and ICANS was observed. No additional dose limiting toxicities were observed since the initial data release in March 2021. Phase 1a - Clinical activity: IMA203 demonstrated a high initial objective response rate in several solid tumor types. At data cut-off on September 6, 2022, a total of 27 patients received IMA203 monotherapy in the Phase 1a dose escalation trial: High initial objective response rate of 48% was observed at the first CT scan post infusion at ~week 6, and a confirmed ORR of 19% the second CT scan at ~week 12. 7 out of 27 patients received doses above 1 billion TCR-T cells; initial ORR was 57% and confirmed ORR was 29% in these patients. Patients were heavily pre-treated with a mean of 4.2 lines of prior systemic treatment and a particularly high baseline tumor burden. The provisional recommended Phase 2 dose for Phase 1b dose expansion was determined to be DL4. Phase 1b Cohort A - Clinical activity: IMA203 monotherapy demonstrates high confirmed objective response rate of 80% with early signs of prolonged durability. At data cut-off on September 6, 2022, 5 patients received IMA203 monotherapy at DL4 and DL5 in the Phase 1b cohort A dose expansion trial: 4 out of 5 patients experienced an initial objective response at ~week 6. In all 4 patients, objective responses were confirmed at ~week 12 and were ongoing at data cut-off: confirmed ORR was 80%. All 4 responses were observed in different solid tumor types: cutaneous melanoma, ovarian cancer, uveal melanoma and head and neck cancer. Patients were heavily pre-treated with a mean of 4.0 lines of prior systemic treatment and high to moderate baseline tumor burden.

07:35 EDT Gaming and Leisure, Penn Entertainment agree to new master lease terms - Gaming & Leisure Properties (GLPI) announced that it agreed to create a new master lease with PENN Entertainment, Inc. (PENN) for seven of PENN's current properties. The companies have also agreed to a funding mechanism to support PENN's pursuit of relocation and development opportunities at several of the properties included in the new master lease. The transaction, including the creation of the new master lease, is subject to customary regulatory approvals and is expected to be effective January 1, 2023. Pursuant to the terms agreed upon by the parties, the current PENN master lease will be amended to remove PENN's properties in Aurora and Joliet, Illinois; Columbus and Toledo, Ohio; and Henderson, Nevada and those properties will be added to the new master lease. In addition, the existing leases for the Hollywood Casino at The Meadows in Pennsylvania and Hollywood Casino Perryville in Maryland will terminate and these properties will be transferred into the new master lease. GLPI has agreed to fund up to $225 million for the relocation of PENN's riverboat casino in Aurora at a 7.75% cap rate and to fund up to $350 million for the relocation of the Hollywood Casino Joliet as well as the construction of hotels at Hollywood Casino Columbus and a second hotel tower at M Resort Spa Casino at then current market rates. The new master lease and GLPI's funding commitment will allow PENN to pursue several growth projects including the planned projects in Aurora and Joliet, Illinois; Columbus, Ohio; and Henderson, Nevada. The terms of the new master lease and the amended PENN master lease are expected to be substantially similar to the current PENN master lease with the following key differences: The new master lease will be cross-defaulted, cross-collateralized and co-terminus with the existing PENN master lease; The initial term of the new master lease will expire on 10/31/2033, with three 5-year extensions at PENN's option; All rent in the new master lease will be fixed with annual escalation of 1.50%, with the first escalation occurring for the lease year beginning on November 1, 2023; The rent for the new lease will be $232.2 million in base rent. The rent for the original PENN master lease will be $284.1 million, consisting of $208.2 million of Building Base Rent, $43.0 million of land base rent, and $32.9 million of percentage rent.

07:33 EDT Iovance Biotherapeutics doses first patient with PD-1 inactivated TIL therapy - Iovance Biotherapeutics announced that the first patient was dosed, and completed the safety observation period, in the IOV-GM1-201 trial of Iovance's genetically modified, PD-1 inactivated tumor infiltrating lymphocyte, TIL, therapy, IOV-4001. IOV-GM1-201 is a Phase 1/2, first-in-human study investigating the safety and efficacy of IOV-4001 in patients with previously treated metastatic non-small cell lung cancer or advanced melanoma. Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, "Dosing the first patient with IOV-4001 is an important first step in providing proof-of-concept for delivering genetically modified TIL therapy to solid tumor patients with significant unmet needs and few treatment options. We look forward to dosing the next patient. This trial may also support our broader platform of genetically modified Iovance TIL therapies to potentially address difficult-to-treat solid tumor cancers."

07:09 EDT Smart Share Global receives notice of noncompliance from Nasdaq - Smart Share Global announced that it has received a written notification from the staff of the Listing Qualifications Department of The Nasdaq Stock Market dated October 7, 2022, indicating that for the last 30 consecutive business days, the closing bid price of the Company's American depositary shares was below the minimum bid price of US$1.00 per share requirement set forth in Nasdaq Listing Rule 5450(a)(1). The Nasdaq notification letter has no current effect on the listing or trading of the Company's ADSs on Nasdaq. Pursuant to the Nasdaq Listing Rule 5810(c)(3)(A), the Company is provided with a compliance period of 180 calendar days, or until April 5, 2023, to regain compliance under the Nasdaq Listing Rules. If at any time during the 180-day compliance period, the closing bid price of the Company's ADSs is US$1.00 per share or higher for at least ten consecutive business days, Nasdaq will provide the Company written confirmation of compliance and the matter will be closed. In the event the Company does not regain compliance by April 5, 2023, subject to the determination by the staff of Nasdaq, the Company may be eligible for an additional 180-day compliance period. The Nasdaq notification letter does not affect the Company's business operations, and the Company will take all reasonable measures to regain compliance within the prescribed grace period.

07:06 EDT Bicycle Therapeutics publishes article with preclinical data from BT8009 program - Bicycle Therapeutics announced that an article highlighting preclinical data from BT8009, a Nectin-4 targeting Bicycle Toxin Conjugate, was published in the Journal of Medicinal Chemistry. The article, titled "Discovery of BT8009: a Nectin-4 Targeting Bicycle Toxin Conjugate for the Treatment of Cancer" is available at the publications section of the Bicycle website at this link. "The pre-clinical data published in the Journal of Medicinal Chemistry describe the discovery of our clinical-stage Bicycle Toxin Conjugate candidate targeting Nectin-4 expressing tumors," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "Together with our study published recently in Molecular Cancer Therapeutics, these articles describe the preclinical work supporting the development of BT8009, which we are currently evaluating in a Phase I/II clinical trial across a number of solid tumor cancers. Nectin-4 is a validated tumor antigen target and we are excited to develop a novel approach to Nectin-4 expressing tumors."

07:06 EDT Axsome Therapeutics joins WHO 2022 World Mental Health Day campaign - Axsome Therapeutics is joining the World Health Organization's 2022 World Mental Health Day campaign to make mental health and well-being for all a global priority.

07:05 EDT First Wave BioPharma presents research on adrulipase drug delivery formulation - First Wave BioPharma announced that research demonstrating key advantages of its improved adrulipase drug delivery formulation will be the subject of a poster presentation at AAPS 2022 PharmSci 360 on October 19. First Wave is developing adrulipase as a treatment for exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. A Phase 2 clinical trial investigating the optimized adrulipase formulation is expected to initiate before year-end 2022. The poster, entitled, "Formulation Development of Enterically Protected Spray Dried Dispersions of Adrulipase," highlights research conducted by First Wave BioPharma and its drug delivery formulation partner, Pace Life Sciences, involving the development of a new drug delivery formulation for adrulipase. In vitro data suggest the formulation has the potential to offer the best protection against the acidic pH in the stomach followed by rapid release of adrulipase in the small intestine. "We are very pleased that research into the development of a microgranule delivery formulation for adrulipase will be highlighted at the AAPS 2022 PharmSci 360 conference," said James Sapirstein, President and CEO of First Wave BioPharma. "As the data indicate, we have been able to identify a drug delivery formulation of adrulipase that should consistently deliver the drug to the precise location in the gastrointestinal tract where it can produce its therapeutic effect. In addition, we have made significant strides in increasing our manufacturing yields and decreasing our cost of goods. We are now in the process of completing the Investigational New Drug application for a proposed Phase 2 clinical trial of this optimized formulation, which we expect to initiate prior to year-end."

07:05 EDT Dragonfly Energy completes business combination with Chardan NexTech - Dragonfly Energy announced that it completed its business combination with Chardan NexTech Acquisition 2 Corp (CNTQ) on October 7, 2022. The combined company will operate under the name Dragonfly Energy Holdings Corp. Commencing today, October 10, 2022, at the open of trading, Dragonfly's common stock and warrants are expected to trade on the Nasdaq Stock Exchange under the symbols "DFLI" and "DFLIW," respectively. The company will continue to be led by Dr. Denis Phares, CEO, alongside the rest of the current Dragonfly management team. The transaction was approved by CNTQ's shareholders at a special meeting held on October 6, 2022. Over 99.9% of the votes cast on the business combination proposal at the Special Meeting were cast in favor of approving the business combination. CNTQ's shareholders also voted to approve all other proposals presented at the Special Meeting. Transaction generated committed capital of ~$250M in gross proceeds consisting of $25M in equity, including the private strategic investment from THOR Industries (THO) that closed in July 2022, $75M senior secured term loan facility led by Energy Impact Partners, and the post-closing availability of a $150M Chardan Equity Facility. Dragonfly intends to use the proceeds to accelerate the market penetration of its existing business and commercialize its proprietary and patented All-Solid-State-Battery technology that will dramatically reduce reliance on the power grid.

07:04 EDT Target says Black Friday deals available now - Target announced its biggest savings of the season starts three weeks earlier than last year with Weeklong Black Friday Deals and the return of the popular Deal of the Day. Both weekly and daily deals are available to shop now and feature the retailer's best planned prices for the holiday season on the most popular national brands and only-at-Target exclusive brands. Whether searching for the perfect on-trend gift, hosting a holiday celebration, or stocking up on everyday essentials, guests will find incredible prices up to 50% off or more across must-have toys and games, electronics, kitchen appliances, and more.

07:03 EDT Nevro comments on UnitedHealthcare medical coverage policy update - Nevro announced that on October 1, UnitedHealthcare released an update to its medical coverage policy and added language to indicate spinal cord stimulation devices are not covered for treating chronic intractable back pain without prior spine surgery. This policy becomes effective on December 1, 2022. All other elements of their SCS coverage policy remained as they were before, including their recent decision to cover the use of SCS for Painful Diabetic Neuropathy. Prior to this change, United had no coverage policy regarding NSBP patients. The company will continue to utilize the outcomes of its SENZA-NSRBP randomized controlled trial for chronic intractable back pain patients without prior spine surgery to support the patient prior authorization and appeals process. The company does not expect this coverage decision to have a material impact on its go-forward revenue, and currently estimates the potential impact on 2023 revenues could be no more than the low to mid-single digit millions of dollars.

06:57 EDT International Game to provide Oregon Lottery with cashless solutions - International Game announced that it will provide the Oregon Lottery with IGT's video lottery account-based cashless solutions via its Intelligen central system. The Oregon Lottery will enable the account-based cashless technologies on the more than 11,500 video lottery terminals (VLTs) throughout the state.

06:54 EDT Turmeric Acquisition to redeem shares, will not consummate business combination - Turmeric Acquisition Corp. announced that it will redeem all of its outstanding Class A ordinary shares, par value $0.0001 previously issued to the public, effective as of the close of business on October 20, because the company will not consummate an initial business combination within the time period required by its Amended and Restated Memorandum and Articles of Association. Net of taxes and dissolution expenses, the per-share redemption price for the Public Shares is expected to be approximately $10.05. In accordance with the terms of the related trust agreement, the company expects to retain $100,000 of the interest and dividend income from the Trust Account to pay dissolution expenses. The company anticipates that the Class A ordinary shares will cease trading as of the open of business on October 20, 2020. As of the close of business on October 20, the Public Shares will be deemed cancelled and will represent only the right to receive the Redemption Amount. The Redemption Amount will be payable to the holders of the Public Shares upon presentation of their respective share or unit certificates or other delivery of their shares or units to the company's transfer agent, Continental Stock Transfer & Trust Company. Beneficial owners of Public Shares held in "street name," however, will not need to take any action in order to receive the Redemption Amount. There will be no redemption rights or liquidating distributions with respect to the company's warrants, which will also cease trading as of the open of business on October 20. The company's sponsor has waived its redemption rights with respect to the outstanding outstanding Class B ordinary shares and private placement shares. After October 20, the company shall cease all operations except for those required to wind up the company's business. The company expects that The Nasdaq Stock Market will file a Form 25 with the Commission to delist its securities. The company thereafter expects to file a Form 15 with the Commission to terminate the registration of its securities under the Securities Exchange Act of 1934, as amended.

06:46 EDT Merck reports 'positive' results from Phase 3 STELLAR trial - Merck announced positive top-line results from the pivotal Phase 3 STELLAR trial evaluating the safety and efficacy of sotatercept, an investigational activin receptor type IIA-Fc fusion protein being evaluated as an add-on to stable background therapy for the treatment of pulmonary arterial hypertension. The trial met its primary efficacy outcome measure, demonstrating a statistically significant and clinically meaningful improvement in 6-minute walk distance from baseline at 24 weeks. Eight of nine secondary efficacy outcome measures achieved statistical significance, including the outcome measure of proportion of participants achieving multicomponent improvement (defined as improvement in 6MWD, improvement in N-terminal pro-B-type natriuretic peptide level, and either improvement in WHO FC or maintenance of WHO FC II, and the outcome measure of time to death or the first occurrence of a clinical worsening event. The Cognitive/Emotional Impacts domain score of PAH-SYMPACT, which was assessed as the ninth and final secondary outcome measure, did not achieve statistical significance. The overall safety profile of sotatercept in STELLAR was in general consistent with what has been observed in Phase 2. Results from the study will be presented at an upcoming scientific congress.

06:33 EDT G1 Therapeutics completes enrollment in Phase 3 clinical trial of trilaciclib - G1 Therapeutics announced that the last patient has been randomized in PRESERVE 2, G1's Phase 3 clinical trial of trilaciclib in patients with metastatic triple negative breast cancer receiving chemotherapy. The trial includes 187 patients receiving first line trilaciclib or placebo prior to gemcitabine and carboplatin. The U.S. FDA has granted Fast Track designation to trilaciclib investigation for use in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer.

06:14 EDT Terreno Realty reports Q3 occupancy of 98.4% vs. 97.9% in Q2 - Last Thursday, Terreno Realty reported: As of September 30, 2022, Terreno Realty Corporation owned 252 buildings aggregating approximately 15.4 million square feet and 46 improved land parcels consisting of approximately 159.9 acres. In addition, Terreno Realty Corporation had two properties under redevelopment that, upon completion, will consist of two improved land parcels aggregating approximately 12.1 acres: The operating portfolio was 98.4% leased at September 30, 2022 to 575 tenants as compared to 97.9% at June 30, 2022 and 98.0% at September 30, 2021; The same-store portfolio of approximately 12.2 million square feet was 98.9% leased at September 30, 2022 as compared to 98.0% at June 30, 2022 and 98.6% at September 30, 2021; The improved land portfolio of 46 parcels, excluding two parcels under redevelopment, totaling approximately 159.9 acres was 91.6% leased at September 30, 2022 as compared to 97.0% at June 30, 2022 and 96.1% at September 30, 2021. Occupancy at September 30, 2022 included acquired vacancy of 6.7 acres (approximately 430bps); Cash rents on new and renewed leases totaling approximately 0.7 million square feet and 5.1 acres of improved land commencing during the third quarter increased approximately 65.9% with a tenant retention ratio of 76.2% for the operating portfolio and 53.3% for the improved land portfolio. Cash rents on new and renewed leases totaling approximately 1.9 million square feet and 16.5 acres of improved land commencing during the nine months ended September 30, 2022 increased approximately 50.3% with a tenant retention ratio of 51.4% for the operating portfolio and 74.2% for the improved land portfolio."

06:06 EDT eHealth appoints Jana Brown as chief people officer - eHealth announced the appointment of Jana Brown as SVP, chief people officer. Brown joins eHealth from Centurion Health, where she served as EVP and chief human resource officer.

06:03 EDT New Oriental Education updates status under HFCAA - New Oriental Education updated its status under the Holding Foreign Companies Accountable Act, or HFCAA. The company filed its annual report on Form 20-F for the fiscal year ended May 31 with the SEC on September 29 and was provisionally named by the United States Securities and Exchange Commission as a Commission-Identified Issuer on October 6. This is the first time that the company was named so after the SEC started to make such identification pursuant to the HFCAA and its implementation rules issued thereunder. The company understands that this identification indicates that the SEC determines that the Company used an auditor whose working paper cannot be inspected or investigated completely

05:09 EDT Stellantis, GME Resources sign MOU for battery grade nickel and cobalt sulphate - Stellantis and GME Resources announced the signing of a non-binding memorandum of understanding, or MOU, for the future sale of quantities of battery grade nickel and cobalt sulphate products from the NiWest Nickel-Cobalt Project in Western Australia. NiWest is an advanced nickel-cobalt development project and will produce approximately 90,000 tons per annum of battery grade nickel and cobalt sulphate for the burgeoning electric vehicle market. To date, more than A$30M has been invested into drilling, metallurgical test work and development studies. A Definitive Feasibility Study for NiWest is due to commence this month. The proposed location of the processing facility for NiWest is within approximately 30 kilometers of Glencore-owned Murrin Murrin operation, the largest nickel-cobalt operation in Australia. The closing of the non-binding MOU is subject to customary closing conditions, including regulatory approvals.

05:04 EDT Nutanix provides update on U.S. expansion - Nutex provided a corporate update. The company reiterated that it expects to open 20 new facilities by the end of 2024, resulting in expansion into four new states: Florida, Wisconsin, Ohio and Idaho. These facilities are either under construction or in advanced planning stages. The company has formed two new independent practice associations, or IPAs, one in Houston and one in South Florida, and is actively working on contracting with primary care physicians and specialists. Once this phase is completed, the company expects to contract with health insurance plans and start enrolling patients in 2023. Nutex also anticipates forming one more IPA in 2022 in Phoenix, Arizona, where it already operates two micro hospitals. The company currently operates one IPA in Los Angeles, California with over 22,000 patients. In addition, the company is actively exploring building additional micro hospitals and anticipates launching one to three additional IPAs per year around its existing micro hospitals. As of September 30, the company had cash and cash equivalents of approximately $35M. This estimate is preliminary only and may change prior to the release of the company's next quarterly financial information. As disclosed in the company's 10-Q for the second quarter of 2022, for the six months ended June 30, the company had net revenue of $137.2M, net income attributable to Nutex Health of $2.1M, EBITDA of $29.7M and adjusted EBITDA of $33.6M. There can be no assurance that these new facilities and IPAs will open and be operational in the anticipated timeframes or that they will open at all.