Stockwinners Market Radar for September 16, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:18 EDT Arctic Vision, Eyenovia to partner on MydCombi commercialization in China, Korea - Arctic Vision announced that it will expand its exclusive license agreement with Eyenovia to include a third asset, MydCombi, for development and commercialization in Greater China and South Korea. MydCombi is Eyenovia's proprietary, first-in-class combination microdose formulation of tropicamide and phenylephrine for mydriasis. MydCombi was developed leveraging the Optejet dispenser, Eyenovia's proprietary microdose array print formulation and delivery platform, to ensure consistent and easy application of two mydriatic medications in a quick, high-precision, and touchless, micro-mist application. In August 2020, Arctic Vision entered into an exclusive license with Eyenovia for the development and commercialization of ARVN002 for treatment of paediatric progressive myopia and ARVN003 for presbyopia treatment in Greater China and South Korea. In China, IND applications for Phase III studies of ARVN002 and ARVN003 have both been cleared.

18:33 EDT Agenus to present data on combination of Balstilimab and Zalifrelimab at ESMO - Agenus presented final results from the Bal/Zal combination study at the European Society for Medical Oncology Virtual Conference 2021 in an abstract titled Balstilimab in combination with zalifrelimab: final results from a Phase 2 study in patients with recurrent/metastatic cervical cancer... The Phase 2 trial was conducted in 155 patients with recurrent/metastatic cervical cancer which has limited effective treatment options and disproportionately affects younger women. In the 125 evaluable patients, the objective response rate in all patients was 26%, with 9% of patients achieving a complete response, and 17% of patients achieving a partial response. The median duration of response was not reached after a 19.4-month median follow-up. Notably, responses were also observed in the PD-L1 negative and adenocarcinoma populations, with 9% of both patient groups achieving an ORR. Based on these observations, we predict more than half of the patients to be alive beyond 12 months. The Bal/Zal combination continued to show no unexpected toxicities and no new safety signals were identified. Steven O'Day, MD, Chief Medical Officer of Agenus, stated: "With a median follow-up of almost 2 years, the Bal/Zal combination showed high response rates, durable clinical activity, and promising overall survival results. Furthermore, later this year we expect to present new data on our next-generation CTLA-4 inhibitor AGEN1181, which we expect to further define the positive role this combination strategy could have in addressing unmet needs for cancer patients."

18:29 EDT Coherus, Junshi to present PFS, OS results from JUPITER-06 - Coherus Biosciences and Shanghai Junshi Biosciences announced positive interim results from the pivotal study "JUPITER-06," a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with chemotherapy as a first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma. The study met the co-primary endpoints with statistically significant and clinically meaningful improvements in progression free survival and overall survival for patients treated with the toripalimab and chemotherapy combination compared to chemotherapy alone. The results will be summarized by Dr. Feng Wang, Professor at Sun Yat-sen University Cancer Center, Guangzhou, in a mini-oral session during the ESMO Congress 2021 on Friday, September 17, 2021 at 12:05 pm Eastern Time. The abstract is now available on the ESMO website. "The findings of this interim analysis provide strong evidence that the addition of toripalimab to chemotherapy as a first-line treatment for advanced or metastatic ESCC patients has superior PFS and OS than chemotherapy alone," said Dr. Wang. "We look forward to updated analyses of overall survival of the JUPITER-06 study in the future and believe that these results will build a strong argument to support the use of toripalimab in combination with chemotherapy as a new standard first-line treatment in patients with advanced or metastatic ESCC." "A strong and consistent efficacy and safety profile is emerging for toripalimab across multiple tumor types as data read out from pivotal clinical trials in melanoma, nasopharyngeal carcinoma, urothelial cancer, lung cancer and now also esophageal squamous cell carcinoma," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "We believe toripalimab could be a potential new treatment choice where patients truly need better options. We will collaborate with Coherus to advance a BLA supplement for ESCC to make toripalimab available as quickly as possible for these patients in the U.S."

18:05 EDT McAfee CFO sells 29,630 class A shares - In a regulatory filing, McAfee CFO Venkat Bhamidipati disclosed the sale of 29,630 class A common shares of the company on September 14 at a price of $21.7125 per share.

18:04 EDT McAfee CEO Leav sells nearly 130,000 class A shares - In a regulatory filing, McAfee president and CEO Peter Leav disclosed the sale of 129,591 class A common shares of the company on September 14 at a price of $21.7125 per share.

17:31 EDT Ballard Power launches FCmove product for buses and trucks - The company states: "Ballard Power Systems announced the launch of the FCmove-HD+, designed for buses and medium and heavy-duty trucks, and is the latest product in Ballard's 8th generation heavy duty power module portfolio. Since 2019, Ballard has been developing a family of FCmove products to serve the commercial vehicle market. The new FCmove-HD+, with a 100kW power output, is smaller, lighter, more efficient, and lower cost than previous generations, and has been designed to improve ease of vehicle integration. With its compact innovative design, it has been engineered for both engine bay and rooftop configurations, enabling optionality in truck and bus applications. The FCmove-HD+ is more than 40% more compact and over 30% lighter than the previous 100kW module, with 50% less component parts. This results in an anticipated 40% improvement in total lifecycle cost while maintaining leading operating performance, high efficiency, and wide operating range. FCmove products are being integrated by our bus and truck OEM partners. The first vehicles powered by the 100kW, FCmove-HD+ are anticipated in 2022, including in the fuel cell trucks recently announced with Hexagon Purus and QUANTRON."

17:27 EDT ShotSpotter CFO Stewart purchases 5K shares of company stock - ShotSpotter CFO Alan Stewart disclosed in a filing that he had purchased 5,000 shares of company stock at $34.74 per share between September 14 and September 15, for a total transaction value of $173,716.

17:23 EDT VeriSign CEO sells 8K shares of common stock - In a regulatory filing, VeriSign disclosed that its CEO James Bidzos sold 8K shares of common stock on September 14th in a total transaction size of $1.78M, reducing his stake by about 1%.

17:01 EDT Nexa Resources names Ignacio Rosado CEO, replacing Tito Martins - Nexa Resources announced that Ignacio Rosado has been selected to replace current President and Chief Executive Officer Tito Martins. Rosado will join Nexa on November 1, 2021 and start an orderly transition process with Martins, who will remain as CEO until December 31, 2021 to assist during the transition period. "As part of our long-term CEO succession planning, and following an extensive and careful search by the nominating and governance committee of our Board of Directors, we believe Mr. Rosado is uniquely qualified to build on the Company's achievements under Mr. Martins' leadership, and we are confident in his ability to continue Nexa's strong results, creating sustainable value", said Jaime Ardila, Chairman of the Board of Directors.

16:46 EDT Emcor CEO sells 13,247 common shares - In a regulatory filing, Emcor chairman, president, and CEO Anthony Guzzi disclosed the sale of 13,247 common shares of the company on September 15 at a price of $118.038 per share.

16:40 EDT Atlas Crest Investment, Archer close business combination - Archer Aviation announced that it has closed its business combination with Atlas Crest Investment (ACIC). Upon the completion of the transaction, Atlas Crest changed its name to "Archer Aviation Inc." Archer's common stock and warrants will commence trading on the New York Stock Exchange on September 17, under the ticker symbols "ACHR" and "ACHR WS", respectively.

16:38 EDT Pedevco CEO Kukes buys 100K shares of company stock - Pedevco CEO Simon Kukes disclosed in a regulatory filing that he had purchased 100,000 shares of company stock at $1.41 per share on September 15, for a total transaction value of $140,900.

16:34 EDT International Game awarded 10-year contract by Connecticut Lottery - International Game subsidiary IGT Global Solutions has won a facilities management lottery contract from the Connecticut Lottery Corporation following a competitive procurement. The contract includes an implementation period to install a new central system, which is expected to go live in April 2023. Once the system is live, the contract will run for 10 years through April 2033, with an additional five years of extension options. IGT will deliver its Aurora central lottery management system through a system conversion that replaces the system currently in place. In addition, IGT will distribute 3,000 Retailer Pro and Retailer Compact lottery terminals, along with 200 GameTouch 28 self-service vending machines to lottery retailers.

16:33 EDT Carrier Global to acquire BrokerBay, terms undisclosed - Carrier Global has signed an agreement to acquire BrokerBay. Supra has been serving the real estate industry for over 60 years, with mobile credentialing technology deployed across an installed base of 4M locking devices in multiple industries. Following closing, which is expected in October, BrokerBay and Supra will provide a shop for realtors that combines scheduling and mobile lockbox access. The terms of the transaction were not disclosed.

16:30 EDT W.P. Carey raises quarterly dividend to $1.052 per share from $1.05 - The dividend is payable on October 15, 2021 to stockholders of record as of September 30, 2021.

16:19 EDT Usana raises share repurchase program to $150M - The company reported that its Board of Directors has increased the company's share repurchase authorization to $150M, which is inclusive of the $14M remaining under the share repurchase authorization as of September 16.

16:18 EDT IFF appoints Glenn Richter CFO - IFF announced that Glenn Richter has been appointed executive VP and CFO, effective September 27. Richter was most recently CFO of TIAA. He succeeds Rustom Jilla, who will be leaving the company following a period of transition. With this appointment, Richter becomes a member of IFF's executive committee.

16:16 EDT Scientific Games names Connie James as new CFO - Scientific Games announced the appointment of Connie James as Executive Vice President, CFO, Treasurer and Corporate Secretary, effective October 15, 2021. Ms. James has served as Chief Financial Officer of Scientific Games' Gaming business since January 6, 2020. Current CFO Mike Eklund will be stepping down to pursue other opportunities and will remain with the company until October 15, 2021.

16:15 EDT Tanger Factory raises quarterly dividend by 2.8% to 18.25c per share - The dividend is payable on November 15, 2021 to common shareholders of record on October 29, 2021.

16:09 EDT Align Technology introduces exclusive professional whitening system - Align Technology, iTero intraoral scanners and exocad CAD/CAM software for digital orthodontics and restorative dentistry, announced an exclusive supply and distribution agreement with Ultradent Products, a developer and manufacturer of high-tech dental materials, devices, and instruments worldwide. As part of the multi-year agreement, Align will offer Invisalign trained doctors an exclusive professional whitening system with the Opalescence PF whitening formula from Ultradent, optimized for use with Invisalign clear aligners and Vivera retainers. The system will carry the co-branded name of 'Invisalign Professional Whitening System - powered by Opalescence' and will offer whitening outcomes and practice experience from the Opalescence PF product during active tooth movement with Invisalign aligners, as well as during passive retention using Vivera retainers. The Invisalign Professional Whitening System will be commercially available globally in 2022.

16:05 EDT Floor & Decor launches Waltham, MA store - Floor & Decor will expand its nationwide footprint when it opens the doors to its newest location in Waltham, Massachusetts on September 23, 2021. This opening marks the third store in the Massachusetts market.

16:01 EDT Northern Trust Asset Management names Angelo Manioudakis CIO - Northern Trust Asset Management announced that Angelo Manioudakis has been named Chief Investment Officer for the global financial institution with more than $1.2T in assets under management as of June 30, 2021. He will assume the position on September 27. Manioudakis will be reporting to Northern Trust Asset Management President Shundrawn Thomas, who said, "Angelo has a proven track record of leadership in the investment management industry spanning three decades. His experience is ideally aligned with our investment philosophy centered on compensating investors for the risk they take in all market environments."

15:57 EDT New Jersey reports August gaming revenue up 31.0% to $427.7M - New Jersey's Division of Gaming Enforcement reports total gaming revenue for August was $427.7M, compared to $326.3M in August 2020, reflecting a 31.0% increase. Casino win for August was $262.4M compared to $199.1M in August 2020. Internet gaming win was $113.2M in August compared to $87.8M in the prior period, reflecting an increase of 29.0%. Sports wagering gross revenue was $52.0M for the month. Publicly traded companies in the casino, sports betting and iGaming space include Boyd Gaming (BYD), Caesars (CZR), Churchill Downs (CHDN), DraftKings (DKNG), Flutter Entertainment (PDYPY), Gan Limited (GAN), Las Vegas Sands (LVS), MGM Resorts (MGM), Penn National (PENN), William Hill (WIMHY) and Wynn Resorts (WYNN).

15:23 EDT Square says investigating issues with debit transactions - Square's official support account on Twitter stated: "Our engineers are investigating issues with debit transactions. We'll continue to share information as we receive updates on https://ca.issquareup.com. We apologize for the disruption." Reference Link

14:39 EDT Dominion and trade unions reaffirm commitment on CVOW, project - Dominion Energy Virginia, the NABTU and their state affiliate Virginia Building Trades reaffirmed their commitment to the participation of a unionized workforce in the construction of the Coastal Virginia Offshore Wind, CVOW, project and also affirmed their commitment to utilizing local workers; the hiring, apprenticeship, and training of veterans; and the use of workers from historically economically disadvantaged communities. Dominion Energy will work collaboratively with NABTU and its affiliates on tripartite discussions with CVOW suppliers to promote project labor agreements to maximize union labor performance of the onshore electrical infrastructure work, turbine pre-assembly work, and offshore work. For the offshore work in particular, the parties will work together to identify the skills training, and schedule necessary to accelerate an offshore wind U.S union construction workforce. "This agreement is another important step forward in making Virginia the nation's leader in clean energy and offshore wind," said Governor Ralph S. Northam. "It's good news to see more well-paying clean energy jobs on the way. Once again, Virginia companies and labor groups together are demonstrating that the Commonwealth is a great place to work and do business."

14:05 EDT Biomea Fusion Inc trading resumes

13:48 EDT Berkeley Lights down for second day after short-seller Scorpion sets $0 target - Shares of Berkeley Lights are down a further 19% in Thursday trading after the stock fell yesterday following the publication of a short report targeting the company from Scorpion Capital. According to Scorpion, which set a target price of $0 for the stock, Berkeley Lights is "fleecing customers and IPO bagholders with a $2M black box that's a clunker." The firm claims to have interviewed customers who allege they were "tricked," misled, or over-promised regarding the company's cell screening systems. In addition, the firm claims its interviews with ex-employees "corroborate the scathing feedback from customers." Reference Link

13:36 EDT Biomea Fusion announces FDA clearance of IND for BMF-219 - Biomea Fusion announced that the U.S. Food and Drug Administration has cleared the company's Investigational New Drug, or IND, application to begin a Phase I trial of BMF-219, a selective irreversible menin inhibitor, in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation. The Phase 1, first-in-human, open-label, dose-escalation and dose-expansion clinical trial of BMF-219 will assess the safety, pharmacokinetic and pharmacodynamic profile of BMF-219 in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation.

13:11 EDT Matterport appoints Pranab Sinha as CIO - Matterport announced that Pranab Sinha has joined the company as chief information officer. Pranab will lead business services strategies that drive resiliency and operational effectiveness as the company continues to grow and scale globally. He brings more than 20 years of experience leading high-performing teams responsible for all aspects of IT vision, security, infrastructure, applications and SaaS execution.Pranab comes to Matterport from Genesys, a company in multichannel customer experience and contact centers solutions where he was the CIO.

13:05 EDT Caesars expects Virginia casino to to break ground by the end of year - Caesars Entertainment shared official renderings today for Caesars Virginia, its $500M resort expected to break ground by the end of the year in Danville. The casino will feature more than 1,400 slot machines and table games, Caesars Sportsbook and a live poker room.

13:01 EDT Caesars named sports betting and casino partner of Indianapolis Colts - The NFL's Indianapolis Colts and Caesars Entertainment announced a partnership making Caesars Sportsbook a premier sports betting partner and the only official casino partner of the team. The new multi-year agreement expands upon the existing Colts-Caesars partnerships with Harrah's Hoosier Park Racing & Casino and Indiana Grand Racing & Casino, the team and company stated. "Expanding our sponsorship with the Colts to serve as their premier sports betting partner and only casino partner is an exciting step in our longstanding relationship," added Chris Holdren, Co-President of Caesars Digital.

12:58 EDT AEye Inc trading resumes

12:16 EDT Moderna says Canada approves Covid vaccine for ages 12 and older - Moderna announced Health Canada has approved the new drug submission for Spikevax for active immunization to prevent COVID-19 in individuals 12 years of age and older. The Moderna Covid-19 vaccine was originally authorized in Canada under an interim order for individuals 18 years of age and older granted by Health Canada on December 23, 2020. On August 27, 2021, Health Canada expanded order authorization to include adolescents 12 years of age and older.

12:00 EDT Direxion Daily Jr Gld Mnrs Bull 3X Shrs falls -10.2% - Direxion Daily Jr Gld Mnrs Bull 3X Shrs is down -10.2%, or -$6.71 to $59.01.

12:00 EDT Coeur Mining falls -13.4% - Coeur Mining is down -13.4%, or -95c to $6.14.

12:00 EDT Spire Global rises 26.5% - Spire Global is up 26.5%, or $2.59 to $12.35.

11:53 EDT Facebook's WhatsApp piloting in-app local business directory - Will Cathcart, head of Facebook's WhatsApp, said that WhatsApp is starting to pilot a local business directory within the app. "This will help you find and contact local businesses, like your neighborhood coffee shop, florist, clothing store and more," Catchart said via Twitter. "We're kicking this off in Sao Paulo which is home to millions of small businesses." Reference Link

11:35 EDT Ford investing additional $250M into F-150 Lightning truck production - Ford said it is investing an additional $250M and adding 450 more jobs across the Rouge Electric Vehicle Center, Van Dyke Electric Powertrain Center and Rawsonville Components Plant as the first pre-production F-150 Lightning trucks roll out. he investment and added jobs will help increase production capacity to 80,000 trucks a year, the company said in a statement. Ford has taken more than 150,000 reservations for the trucks to date. "We knew the F-150 Lightning was special, but the interest from the public has surpassed our highest expectations and changed the conversation around electric vehicles. So we are doubling down, adding jobs and investment to increase production," said Bill Ford, executive chair, Ford Motor Company.

10:52 EDT SunPower up 1% to $21.93 after announcing California pact with Toll Brothers

10:20 EDT Pfizer recalls all lots of Chantix on presence of a nitrosamine - Pfizer (PFE) announced it is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg tablets to the patient level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. "As alternative suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure," the company said in a statement. Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication, it added. Pfizer said any product in inventory should be returned to Stericycle (SRCL). Reference Link

10:03 EDT Babcock & Wilcox acquires 60% stake in Fosler Construction - Babcock & Wilcox last night announced that it has signed a definitive agreement to acquire a majority ownership stake in Illinois-based solar energy contractor Fosler Construction Company. The transaction is expected to close at the end of September. Fosler Construction will be part of B&W's Renewable segment and will continue to be led by its Chief Executive Officer Paul Fosler, who will retain a minority ownership in the company. Fosler Construction provides commercial, industrial and utility-scale solar services and owns two community solar projects in Illinois being developed under the Illinois Solar for All program. "The company is positioned to capitalize on the high-growth solar market in the U.S., with a near-term pipeline of more than 1 gigawatt of solar capacity," Babcock & Wilcox said.

10:00 EDT Direxion Daily Jr Gld Mnrs Bull 3X Shrs falls -10.0% - Direxion Daily Jr Gld Mnrs Bull 3X Shrs is down -10.0%, or -$6.58 to $59.14.

10:00 EDT Great Western rises 13.9% - Great Western is up 13.9%, or $3.97 to $32.57.

10:00 EDT IronNet rises 19.2% - IronNet is up 19.2%, or $6.18 to $38.31.

09:47 EDT X Financial falls -7.6% - X Financial is down -7.6%, or -31c to $3.77.

09:47 EDT Blue Apron falls -9.8% - Blue Apron is down -9.8%, or -55c to $5.06.

09:47 EDT IronNet rises 25.7% - IronNet is up 25.7%, or $8.27 to $40.40.

09:43 EDT Sabre, Etihad announce long-term partnership with technology renewals - Sabre Corporation announced a renewed technology agreement with Etihad. Under the new agreement, Etihad will continue leveraging a suite of Sabre's industry-leading IT solutions to aid recovery, help drive post-pandemic growth and enhance the passenger experience. Under the new multi-year agreement, the following products will be among a suite of technology for Etihad as it focuses on optimizing its operations to fuel its recovery: Fares Optimizer - Uses near real-time responses to provide dynamic price recommendations for Etihad's fares. Network Planning and Optimization - this planning and scheduling suite is able to scale to the largest airlines in the world. Inflight - In previous years of using Sabre's Inflight solutions, Etihad has been able to achieve significant savings, while continuing to provide a guest experience onboard.

09:20 EDT Cameco, X-energy to explore collaboration for Xe-100 SMRs - Cameco and X-energy have entered a non-binding and non-exclusive Memorandum of Understanding to explore possible areas of cooperation to support the potential future deployment, fuelling and servicing of Xe-100 small modular reactors in Canada and the United States.

09:17 EDT SPAC Rotor Acquisition say holders approve combination with Sarcos Robotics - Rotor Acquisition a publicly-traded special purpose acquisition company, announced that its shareholders voted to approve the business combination with Sarcos Robotics, a company in the development of robotic systems that augment humans to enhance productivity and safety. Upon completion of the transaction, subject to the satisfaction of certain customary closing conditions, Rotor will change its name to Sarcos Technology and Robotics Corporation. The post-closing company's common stock and warrants are expected to commence trading on the Nasdaq on September 27 . under the ticker symbols "STRC" and "STRCW," respectively. The current Sarcos management team, including chairman and CEO Ben Wolff, will continue to lead the company. The company's new board of directors will be comprised of current and former leaders from Apple, The Boeing Company, Credit Suisse, Delta Air Lines, Microsoft, Nextel, and the U.S. Department of Defense. "The growing shortage of skilled workers that are able to conduct physically demanding tasks is a critical problem for companies, industries, and the global economy," said Ben Wolff, chairman, and CEO, Sarcos. "Sarcos has a unique opportunity to usher in a new age of human and machine collaboration by deploying a fleet of its highly dexterous mobile robotic systems that augment humans rather than replace them. We think we can put a meaningful dent in the skilled labor shortage challenges by enabling skilled workers and the companies they work for to be more productive and safer across a wide range of industries for those jobs where automation is not feasible. Consummation of the business combination with Rotor will help ensure that Sarcos has the resources we need to realize our vision for a safer and more productive industrial workforce of the future."

09:13 EDT Clarus Therapeutics, McGill announce exclusive licensing agreement - Clarus Therapeutics Holdings and McGill University announced a licensing agreement whereby Clarus will develop and commercialize McGill's proprietary technology designed to treat conditions associated with CoQ10 deficiencies in humans. "This collaboration with world-renowned McGill University expands our focus beyond androgen-based medicines to a metabolic therapy for CoQ10 deficiencies that have very limited treatment options," said Dr. Robert Dudley, Clarus's Founder, President and Chief Executive Officer. "Knowing the role McGill's discovery may have to address this important, unmet medical need is a terrific opportunity, and we are excited to get started." Under the terms of the licensing agreement, Clarus will pay McGill a one-time upfront payment of $350,000 and up to $10.5M in potential development and regulatory milestone payments. Additionally, McGill would be eligible for up to $30M in potential commercial milestone payments. The success-based milestones denote important steps associated with building value for these programs.

09:09 EDT Neovasc announces FDA approval of COSIRA-II clinical trial - Neovasc announced that it has received FDA approval for the Investigational Device Exemption, or IDE, regarding the COSIRA-II IDE Clinical Trial. Following multiple discussions with FDA over the past several months, the approved protocol for the COSIRA-II study is designed to answer key questions arising from the October 2020 Circulatory Systems Devices Panel Meeting regarding the Neovasc Reducer. The approval of the supplement is consistent with Neovasc's internal target, and the Company remains on track to enroll the first patient in the trial late this year. COSIRA-II is a randomized, sham-controlled trial investigating the safety and effectiveness of the Reducer for patients suffering from refractory angina. The primary endpoint of the trial is change in exercise tolerance testing time via a modified Bruce protocol between baseline and six-month follow-up. The study is planned to enroll approximately 380 patients at up to 50 sites in the United States and will also include limited sites outside of the United States.

09:08 EDT CleanSpark, Partnership Gwinnet announce $145M in capital, human investments - CleanSpark joined Partnership Gwinnett to announce expected capital and human investments of nearly $145 million over the next five years at CleanSpark's data center in Norcross, Georgia. The $6.55 million purchase of the former Sprint/Nextel data center, announced earlier in August, is expected to bring 20 skilled and highly skilled jobs to the community, at an average yearly wage of approximately $50,000. CleanSpark expects the facility to be operational by late 2021. CleanSpark is working with Partnership Gwinnett because of the organization's substantial role in the county and surrounding area. Partnership Gwinnett is supported by over one hundred companies, municipalities, and educational institutions to strengthen Gwinnett County's diverse economy and ability to compete in the global marketplace. In addition to direct upgrades to the facility, CleanSpark is partnering with Georgia Power to invest in a $2 million power expansion. Improvements are expected to benefit power customers and community members living near CleanSpark's new facility. The Company will also participate in Georgia's Simple Solar program and anticipates the addition of onsite renewables, solar installations, and other microgrid energy solutions. The mining operations are expected to be 100 percent carbon neutral.

09:08 EDT USAID awards Tetra Tech infrastructure contracts with shared capacity of $800M - Tetra Tech announced that the U.S. Agency for International Development, USAID, awarded Tetra Tech a multiple-award contract to provide global infrastructure services with a shared capacity of $800M. Under the five-year contract Tetra Tech will provide global architect-engineer services to USAID to drive sustainable economic growth, expand educational opportunities, enhance food security, protect the environment, and address global health challenges. Tetra Tech's engineers, scientists, and architects will provide comprehensive engineering design services to support the development of climate- and seismic-resilient infrastructure programs including water supply and sanitation, transportation, solid waste, electrical grids, and master planning of urban and commercial zones. The U.S. Agency for International Development administers the U.S. foreign assistance program providing economic and humanitarian assistance in more than 100 countries worldwide. "Tetra Tech has provided engineering support services to USAID for more than 15 years," said Dan Batrack, Tetra Tech Chairman and CEO. "We look forward to continuing to apply our Leading with Science(R) approach to design climate-resilient infrastructure across the globe."

09:07 EDT Warner Music, David Bowie sign global, career-spanning partnership - Warner Music Group and the estate of David Bowie have signed a global, career-spanning partnership for Bowie's recorded music catalog. With this new deal, Warner Music will now have worldwide rights to five decades of Bowie's work. Expanding on Warner Music's current agreement with the estate, which encompasses Bowie material from 1968 to 1999, the new licensing agreement will include the entirety of Bowie's 2000-2016 works. Heathen, Reality, The Next Day, and the worldwide No.1 album are among the works that will come into the Warner Music fold in 2023. Max Lousada, CEO, Recorded Music, Warner Music Group said: "It's an incredible honor to have been chosen as the stewards of one of the most important and dynamic bodies of creative work in modern culture. The impact of Bowie's repeated reinvention and endless experimentation continues to resonate around the world - through the genres he transformed, the timeless songs and sounds he invented, and the immeasurable influence he's had on music, art, and fashion. We're excited that our expanded partnership with the Bowie estate will help us deliver innovative, career-spanning projects and attract new generations to his extraordinary musical universe."

09:06 EDT ServiceNow expands partnership with Microsoft - ServiceNow (NOW) announced an expanded strategic partnership with Microsoft (MSFT) to empower employees as they continue to navigate new ways of working. As part of ServiceNow's Now Platform Rome release, the company introduced a new collaborative app for its employee center that integrates with Microsoft Teams and offers employee experiences in the hybrid work environment. The companies also announced expanded investments in co-innovation and go-to-market efforts across ServiceNow workflows and Teams.

09:05 EDT Luokung Technology and Microsoft launch autonomous driving services in China - Luokung Technology's (LKCO) operating affiliate eMapgo Technology, a provider of navigation and electronic map services in China, has signed a cooperation agreement with Microsoft (MFST) to launch autonomous driving services for automakers. EMG will work with Microsoft to provide auto manufacturers with services including the collection, storage, analysis, management and simulation testing of autonomous driving data, to assist automakers in the implementation of autonomous driving technologies in China. EMG and Microsoft plan to form a cooperation that addresses the market opportunities presented by autonomous driving in China. EMG has already obtained service contracts from a European car manufacturer and a U.S. car manufacturer. These contracts are expected to be implemented in the coming months.

09:04 EDT PharmaCyte Biotech announces first test results of CypCaps clinical trial - PharmaCyte Biotech announced the first test results of the biocompatibility studies of its CypCaps clinical trial product candidate. These results were from an "In Vitro Complement Activation Study of Empty Cellulose Sulphate Capsules," the same capsules PharmaCyte uses in its treatment for pancreatic cancer. The complement system consists of multiple proteins, approximately 30 of which are circulating blood proteins that work together to promote immune and inflammatory responses. The complement system's principal role is to help identify, destroy, and remove foreign pathogens such as bacteria and viruses, as well as damaged cell materials. The objective of the ISO 10993-4: 2017 compliant study was to evaluate the complement activation potential of empty cellulose sulphate capsules when mixed with normal human serum complement under in vitro test conditions. The study was performed by a third-party GLP laboratory. That laboratory concluded that empty cellulose sulphate capsules did not activate the complement system under defined experimental conditions based on the results of the study. These results were also supported by statistical comparisons.

09:03 EDT Evoqua Water in pact with Ostara Nutrient Recovery Technologies - Evoqua Water Technologies announced the signing of an exclusive agreement with Ostara Nutrient Recovery Technologies . The collaboration combines Ostara's market-leading process solutions for nutrient recovery with Evoqua's established water and wastewater treatment solutions to help customers recover nutrients and convert them into valuable fertilizers. Under the agreement, Evoqua will lead the sales and implementation of Ostara's unique nutrient recovery solutions into the North America and Western Europe markets. Evoqua's established project delivery resources provide additional strength to further accelerate the growing adoption of nutrient recovery solutions to mitigate the excessive richness of nutrients in lakes and other bodies of water. Nutrient recovery solutions such as these can convert the excessive nutrient loads into a usable, beneficial product.

09:02 EDT L3Harris Technologies awarded $100M order for ENVG-B system - The U.S. Army has awarded L3Harris Technologies a $100M order for the Enhanced Night Vision Goggle - Binocular, or ENVG-B, system that will enhance soldier situational awareness, mobility, survivability and lethality. The ENVG-B delivers imagery and data from the battlefield directly to the soldier's eye. The complete system will interface with the Army's family of weapon sights, while enhancing interoperability and data sharing. This marks the second delivery order L3Harris has received from the U.S. Army for the ENVG-B Program of Record, or POR, which has a total value of $442M. Since 2018, L3Harris has delivered more than 6,000 ENVG-B systems to the Army as part of both the POR and Directed Requirements contracts.

09:02 EDT Clover Health to provide in-home COVID-19 vaccinations to Medicare members - Clover Health announced that it will provide in-home COVID-19 vaccinations, which is especially critical to support Clover's medically-complex and homebound members. Clover has partnered with MedArrive, a healthcare logistics and services platform, to kick off the vaccination program in New Jersey. "Many Clover members have disabilities or face other challenges that can make it difficult for them to leave their homes, even to obtain life-saving medical care like the COVID-19 vaccine," said Kumar Dharmarajan, Associate Chief Medical Officer of Clover Health. "This service allows our most vulnerable members to get essential care in the most timely and convenient way possible, which we believe will ultimately improve their quality of life, reduce hospital admissions and drive down healthcare costs." MedArrive's platform enables payers and providers to leverage a network of EMTs, paramedics and other types of skilled healthcare workers to extend care services into the home to improve patient outcomes while empowering an underutilized segment of the healthcare workforce.

08:56 EDT Calliditas Therapeutics provides regulatory timeline update for Nefecon - Calliditas Therapeutics announced that the European Medicine Agency's Committee for Human Medicinal Products has decided to continue the assessment of the marketing authorization application, or MAA, for Nefecon under standard procedure assessment timelines. Calliditas was in April granted an accelerated assessment procedure on its MAA for Nefecon in IgA Nephropathy and submitted the MAA in May. With the revised standard assessment timeline Calliditas estimates a potential impact of 3 months on the previously communicated timelines with an expected decision by EMA in 1Q22. If approved, Nefecon could be available to patients in Europe in mid-2022.

08:37 EDT Metromile integrates Dwolla to automate insurance claim payments - Metromile Enterprise Solutions announced an integration with Dwolla into its no-code claims automation platform Metromile STREAMLINE. With Metromile STREAMLINE and Dwolla, insurers worldwide can offer digital claims payments, including Real-time Payments via the RTP Network, Automated Clearing House transfers via the ACH Network or Push-to-Debit disbursements, helping to resolve claims more quickly and accurately.

08:36 EDT Phunware selected by Dignity Health, YRMC for mobile healthcare solution - Phunware has secured a new Multiscreen-as-a-Service contract win that will give Dignity Health, Yavapai Regional Medical Center, or YRMC, a new digital front door application portfolio for mobile. Phunware's digital front door enables "feature-rich mobile application solutions for healthcare providers that eliminate the pain of having to manage dozens of point solutions while simultaneously offering staff, patients and visitors a far more simplistic, cohesive and integrated healthcare experience," the company said.. Capabilities include, but are not limited to: Mobile engagement for contextual notifications, including appointment reminders; Real-time "blue dot" indoor positioning, including mapping, navigation and wayfinding; Beacon Maintenance to ensure optimal performance of MaaS Location Based Services; Mobile bill pay; Staff directory; and Analytics. "We are thrilled to work with the YRMC team, who are committed to ensuring that their patients, visitors and clinicians have access to cutting edge technology that demystifies the continuum of care," said Alan Knitowski, President, CEO and Co-Founder of Phunware. "By tech-enabling the healthcare experience at YRMC, we expect to see improvements in operational efficiencies and financial performance, as well as in clinical health outcomes."

08:34 EDT Allison Transmission to buy India-based AVTEC's off-highway assets for $27M - Allison Transmission is pleased to announce that it has signed an asset purchase agreement to acquire the transmission portfolio of India-based AVTEC Ltd.'s off-highway business and AVTEC's Madras Export Processing Zone, MEPZ, off-highway component machining business. Headquartered in New Delhi and part of the CK Birla Group, AVTEC is one of India's largest independent manufacturers of powertrain and precision-engineered products for automotive, off-highway, defense, agriculture and railway industry, in areas of both proprietary products and contract manufacturing. "The acquisition of the transmission portfolio of AVTEC's off-highway business and associated IP will accelerate Allison's pursuit of additional opportunities in these segments in India and global markets with purpose-built products that deliver performance and productivity to our customers," said John Coll, Senior Vice President, Global Marketing, Sales and Service at Allison Transmission. Allison will pay approximately $27M in cash for AVTEC's off-highway transmission portfolio and MEPZ off-highway component machining assets. Allison does not expect the acquisition to have a material impact on current fiscal year earnings. The transaction is subject to completion of certain conditions precedent and is anticipated to close by the end of 2021.

08:33 EDT Color Star Technology to acquire Elephant Games, terms not disclosed - Color Star Technology announces that its wholly-owned subsidiary, Color China, signed an memorandum of understanding to acquire Guangzhou Elephant Interactive Network Technology Co., Ltd., hereinafter referred to as "Elephant Games," to utilize their respective advantages for jointly developing online mobile games for the international market. The two companies will cooperate globally in the areas of game development, copyright distribution, and peripheral product sales. Color China will benefit from the strategic layout and overseas listing experiences of its parent company, Color Star, which provides a diverse interactive game experience for hundreds of millions of players worldwide. Elephant Games specializes in the development and operation of online games with local characteristics.

08:32 EDT Missfresh expands on-demand live seafood delivery business to 8 cities in China - Missfresh is accelerating the rollout of its instant live seafood delivery to customers across China, having seen 20X growth in live seafood delivery sales since March. Missfresh has launched the new category in eight of the country's most populous first-tier and second-tier cities: Beijing, Shanghai, Shenzhen, Tianjin, Hangzhou, Ningbo, Suzhou, and most recently Nanjing. Customers can currently choose from more than 100 products and access test reports for each product in the product details section of the Missfresh app.

08:31 EDT Axalta Coating breaks ground on new coatings facility in Northern China - Axalta broke ground for construction of a state-of-the-art coatings facility in Jilin City, Jilin Province, North China. The 46,000-square-meter new plant will produce mobility coatings to support growing customer demand in China for light vehicles, commercial vehicles, and automotive plastic components. The new plant is scheduled to open in 2023 and will mainly produce basecoats, primers, and clearcoats used in Axalta's eco-friendly processes such as high solids technology.

08:28 EDT Soligenix to advance synthetic hypericin development in psoriasis - Soligenix announced that following the validation of synthetic hypericin's biologic activity in the positive pivotal Phase 3 FLASH study in cutaneous T-cell lymphoma, as well as positive proof-of-concept demonstrated in a Phase 1/2 pilot study, the company will be expanding this novel therapy under the research name SGX302 into psoriasis. Visible light-activated synthetic hypericin is a novel, first-in-class, photodynamic therapy that is expected to avoid much of the long-term risks associated with other PDT treatments. Synthetic hypericin or HyBryte was demonstrated in this study to be equally effective in treating both plaque and patch lesions of this orphan disease. This treatment approach avoids the risk of secondary malignancies inherent with drugs and phototherapies. The use of synthetic hypericin coupled with safe, visible light also avoids the risk of serious infections and cancer associated with the systemic immunosuppressive treatments used in psoriasis.

08:23 EDT Homeowners of America introduces services in Nevada - Homeowners of America announced the launch of service in Nevada. Porch completed its acquisition of HOA in April 2021 with plans to drive growth in HOA's current markets and begin national expansion. With the addition of Nevada, HOA now operates in eight states. This expansion furthers Porch's reach for its InsurTech business, now offering a competitively priced homeowners insurance product to homebuyers, homeowners and HOA agents.

08:21 EDT Adaptive Biotechnologies to present new COVID-19 data from immune platform - Adaptive Biotechnologies will be presenting data from two studies employing Adaptive's immune medicine platform to understand the T-cell response to SARS-CoV-2 infection at IDWeek 2021, which takes places virtually from September 29-October 3, 2021. Adaptive will present new SARS-CoV-2 research at IDWeek that has implications for disease monitoring and vaccine development. A study evaluating the clinical performance of T-Detect COVID, the first T-cell-based test available in the U.S. to confirm recent or prior SARS-CoV-2 infection from whole blood samples, provides continued analysis and real-world evidence that confirms and extends previously published data regarding the durability of the detectable T-cell response, from 5 months up to nearly 12 months in a small number of evaluable patients after an initial positive Reverse Transcription-Polymerase Chain Reaction test result. Similarly, a study employing Adaptive's T-cell assay produced a quantitative picture of the T-cell response to SARS-CoV-2 and demonstrated the assay's ability to distinguish a vaccine response from a natural infection based on the relative absence of T-cell receptors targeting non-spike antigens in vaccinated individuals. "When it comes to understanding SARS-CoV-2, the current focus on the vaccine-induced antibody response is incomplete, because antibodies do not provide the entire picture. T cells are contributing to vaccine efficacy even when the antibody response diminishes," said Lance Baldo M.D., Chief Medical Officer, Adaptive Biotechnologies. "Adaptive's immune medicine platform enables us to identify T-cell response signals repeatedly and reliably from the cells found in a tube of blood, and to translate those insights into therapeutic and diagnostic tools. As we support more patients and our knowledge accelerates, we can scale quickly, exploring applications in infectious diseases and beyond."

08:19 EDT RIP Medical Debt, TransUnion expand partnership - National nonprofit RIP Medical Debt reached a new milestone, helping to relieve more than $5B in medical debt for patients experiencing financial hardship. Medical debts continue to be a nationwide problem. The U.S. Census Bureau indicates that nearly one in five families carry such obligations with a median balance of $2,000. To better support hospitals, health systems, and physician groups in helping patients resolve these debts, TransUnion Healthcare and RIP Medical Debt announced the strengthening of their partnership. The enhanced partnership will allow healthcare providers to more easily implement RIP Medical Debt's model as part of their revenue cycle process.

08:15 EDT CytomX Therapeutics announces employment inducement grants - CytomX Therapeutics announced that on September 15, 2021, the Company granted nine new employees options to purchase a total of 157,200 shares of the Company's common stock at an exercise price per share equal to $4.97, which was the closing trading price on September 15, 2021, the date of the grant. The stock options were granted pursuant to the Company's 2019 Employment Inducement Incentive Plan, which was approved by the Company's board of directors in August 2020 under Rule 5635(c)(4) of The Nasdaq Global Market for equity grants to induce new employees to enter into employment with the Company.

08:12 EDT Worksport starts countdown on website for Terravis System launch - Worksport is excited to start the countdown on a website the Company has been preparing in anticipation of the Terravis System launch. It will provide a simple way for the public to reserve their order spot for the market's first-of-its-kind solar-integrated tonneau cover and COR mobile Energy Storage Systems (ESS), designed and manufactured by Worksport and Terravis Energy. The systems can operate standalone or with the COR ESS, which features hot-swapping technology. For those who prefer to pay for the systems in installments, Worksport will be setting up financing solutions, details of which will be provided closer to full-scale production. Management believes that providing a financing option will be beneficial to the Company and its customers.

08:10 EDT NuCana announces four poster presentations at ESMO Congress - NuCana announced the presentation of four posters at the European Society for Medical Oncology Congress 2021. The Company presented additional data from the ongoing Phase 1b/2 study of NUC-3373 in combination with standard therapies in patients with advanced colorectal cancer, final data from the Phase 1 study of NUC-3373 in patients with advanced solid tumors, and additional interim data from the Phase 1 study of NUC-7738 in patients with advanced solid tumors. The Company also presented a trials-in-progress poster describing the ongoing Phase 3 study of Acelarin plus cisplatin in patients with advanced biliary tract cancer. NuCana presented two posters on NUC-3373, its ProTide transformation of the active anti-cancer metabolite of 5-fluorouracil, one of the most widely used anti-cancer medicines. NUC-3373 has been designed to overcome the main challenges associated with 5-FU, including cancer-resistance mechanisms, the generation of toxic metabolites and unfavorable pharmacokinetics. Poster Title: A Phase Ib study of NUC-3373, a targeted inhibitor of thymidylate synthase, in combination with standard therapies in patients with advanced colorectal cancer: This poster describes encouraging interim data from 38 patients with metastatic colorectal cancer. In this difficult-to-treat group, with patients having received a median of four prior lines of therapy, NUC-3373, with or without leucovorin, demonstrated encouraging signs of efficacy. In addition to several patients achieving a longer progression-free survival on NUC-3373 than they had on their prior therapy, tumor reductions were observed in three patients: one who experienced a 40% reduction in their target lesion and two others with 28% and 15% reductions, respectively, in overall tumor burden. NUC-3373 also demonstrated a favorable safety profile in this patient population with no FBAL or FUTP-associated Grade 3 or 4 toxicities, such as hand-foot syndrome, diarrhea or neutropenia. Based on these encouraging interim results, NuTide:302 has been expanded to a Phase 1b/2 study and now allows enrollment of less heavily pre-treated patients, including second-line colorectal cancer patients. A registrational study of NUC-3373 in second-line colorectal cancer patients is also planned. Poster Title: Final results of a first-in-human study of the ProTide thymidylate synthase inhibitor NUC-3373, in patients with advanced solid tumours: This poster highlights final results from the NuTide:301 study in patients with advanced solid tumors. NUC-3373 showed a favorable safety profile and encouraging anti-cancer activity, including in patients previously treated with 5-FU. Additionally, three patients achieved stable disease lasting at least 9 months. NUC-3373 demonstrated an attractive pharmacokinetic profile with a long plasma half-life of between 6 and 14 hours compared to 8 to 14 minutes for 5-FU. Furthermore, NUC-3373 generated approximately 300 times higher levels of the active anti-cancer metabolite, FUDR-MP, than 5-FU. The recommended Phase 2 monotherapy dose of NUC-3373 was established at 2,500mg/m2. NUC-7738, a ProTide transformation of a novel anti-cancer nucleoside analog, 3'-deoxyadenosine, has multiple potential anti-cancer mechanisms of action and is being evaluated in a Phase 1 study in patients with advanced solid tumors who have exhausted all standard therapies. Poster Title: A first-in-human study of NUC-7738, a ProTide transformation of 3'-deoxyadenosine, in patients with advanced solid tumors: This poster describes interim data from the ongoing Phase 1 study and the data demonstrate NUC-7738's encouraging anti-cancer activity in multiple tumor-types. NUC-7738 has been well tolerated with no Grade 3 or 4 treatment-related adverse events and no dose-limiting toxicities. The ProTide generated high levels of the key anti-cancer metabolite, 3'-dATP, which had a prolonged intracellular half-life and was still detectable after 50 hours. Three case studies were described detailing two patients with metastatic melanoma and one patient with metastatic lung adenocarcinoma who achieved reductions in the size of target lesions coupled with prolonged stable disease. Following treatment with NUC-7738, one patient with metastatic melanoma became eligible for surgery and their tumor was completely resected. Recruitment to the NuTide:701 study is ongoing and once the recommended Phase 2 dose has been established, NUC-7738 is expected to advance into the Phase 2 part of the study. Poster Title: Phase III study of NUC-1031 + cisplatin vs gemcitabine + cisplatin for first-line treatment of patients with advanced biliary tract cancer: This trial-in-progress poster highlights the Company's global multi-center, randomized Phase 3 study comparing Acelarin, a ProTide transformation of gemcitabine, in combination with cisplatin, to gemcitabine in combination with cisplatin in up to 828 patients with advanced biliary tract cancer who have not previously received treatment for advanced disease. Enrollment of 418 evaluable patients has been achieved and the first of three interim analyses is expected to occur in the first half of 2022. NuCana believes that a statistically significant improvement in the Objective Response Rate at the first interim analysis, accompanied by positive trends in other endpoints, has the potential to allow for accelerated approval of a new drug application (NDA) for Acelarin in the United States.

08:09 EDT Nisun International enters strategic cooperation to create financial services - Nisun International has entered into a strategic cooperation agreement with Sunshine Chengyang Financial. Under this agreement, the two parties will enter a cooperation to develop supply chain services targeting the finance industry and build the "Qingdao Sunshine Nisun Supply Chain Platform". Nisun and Sunshine Financial will work together to migrate core resources to Qingdao City's Chengyang District in an effort to accelerate the district's development. Established in September 2020, Sunshine Chengyang Financial is a wholly-owned subsidiary of Chengyang Sunshine Chengyang Holding located in Qingdao City, China. Holding Group was established on December 19, 2019 with a registered capital of RBM5B. It is 100% invested and controlled by the state-owned Assets Development Center of Chengyang District, Qingdao City.

08:07 EDT Cree to transfer the listing of common stock to NYSE, with new ticker symbol - Cree announced that it will transfer the listing of its common stock to the New York Stock Exchange from The Nasdaq Global Select Market. Cree expects to commence trading as a NYSE-listed company at market open on October 4, 2021 under the new ticker symbol 'WOLF'. The Company will continue to trade its common stock on the Nasdaq until the close of the market on October 1, 2021. As previously announced, the Company will also change its corporate name from Cree, Inc. to Wolfspeed, Inc. effective October 4."We are pleased to join the NYSE, one of the world's most prestigious trading platforms, as we continue on our transformational journey as a pure play global semiconductor powerhouse leading the industry transition from silicon to Silicon Carbide," said Gregg Lowe, Chief Executive Officer at Cree Wolfspeed. "Importantly, our company name change to Wolfspeed capitalizes on our 30-year heritage of working with Silicon Carbide and underscores our ambitious plans to compete and win in the rapidly expanding marketplace, which we believe will continue to provide long-term value for our customers and shareholders."

08:06 EDT Braskem announces partnership with Gelmart International - Braskem (BAK) announces its partnership with Gelmart International, a global manufacturer of intimate apparel. Braskem in supplying its I'm green EVA biopolymer to support production of the world's first-of-its-kind plant-based bra cup sourced from sustainably grown sugarcane. Gelmart's new kindly line of sustainable intimate apparel launched in August and is available exclusively across 3,300 Walmart (WMT) retail stores and online at Walmart.com

08:04 EDT Univar and Novozymes to provide biological waste and wastewater solutions - Univar announced a new agreement with Novozymes, a provider of biological solutions, expanding its relationship to include biological solutions for waste and wastewater treatment in the U.S. and Canada. The new agreement follows previous announcements expanding the partnership into a range of markets in the U.S., Canada and Latin America. Novozymes' biological solutions in enzyme- and microbial technology catalyze key processes, transforming, for instance, dissolved organic matter in wastewater into a biomass that can be separated from the treated wastewater and safely disposed.

08:03 EDT Landsea Homes closes on 489 homesites in Fontana's Monarch Hills - Landsea Homes announced that it has closed on 489 homesites in the Monarch Hills master-planned community in Fontana, California. Monarch Hills is spread out across more than 136 acres and backs up to the majestic San Bernardino National Forest, and is the only master planned community in the City of Fontana that will feature homes with views west of the I-15.

08:02 EDT Monopar Therapeutics initiates Phase 1b clinical trial evaluating camsirubicin - Monopar Therapeutics announced its Phase 1b open-label dose-escalation clinical trial of camsirubicin in the US is active and recruiting patients. The trial is evaluating the safety and anti-tumor activity of increasing doses of camsirubicin in combination with growth factor support for the treatment of advanced soft tissue sarcoma. "Camsirubicin has already shown anti-tumor activity comparable to doxorubicin in a pilot study in ASTS patients, without any signs of irreversible heart damage," said Andrew Mazar, PhD, Monopar's Chief Scientific Officer. "We are excited, as the previous study's dose of camsirubicin will be the first dose level in this Phase 1b clinical trial. From there the dose will increase, hopefully with corresponding increases in anti-cancer effect, to identify a recommended Phase 2 dose of camsirubicin when given with concomitant pegfilgrastim."

07:55 EDT EU passenger car registrations down 19.1% in August - In July 2021, the European passenger car market "suffered a significant setback after four months of accelerated growth," with new registrations down 23.2% to 823,949 units, reported the European Automobile Manufacturers Association. During the month of August, car registrations across the European Union decreased by 19.1% - compared to the same month last year - to reach 622,993 units as the largest car markets posted double-digit declines for the second month in a row, the group reported. Publicly traded automakers include Daimler AG (DDAIF), Ford (F), General Motors (GM), Honda (HMC), Nissan (NSANY), Stellantis (STLA), Tesla (TSLA), Toyota (TM) and Volkswagen (VWAGY). Reference Link

07:47 EDT Savaria raises annual dividend 4.17% to 50c per share - Savaria Corporation announces that its Board of Directors approved an increase to the Corporation's monthly dividend, raising it to 4.17c per common share. On an annual basis, this represents an increase of two cents, raising the dividend to 50c per share representing a 4.17% increase. This increase will apply to the dividends payable monthly starting on October 8, 2021 to shareholders of record of the Corporation at the close of business on September 30, 2021. This is an eligible dividend within the meaning of the Income Tax Act.

07:44 EDT Offerpad Solutions up another 38% in pre-market trading at $17.40 - Shares of Offerpad Solutions are up another 38% at $17.40 in pre-market trading following yesterday's 13.7% advance. The stock is in the top-5 in terms of message volume over the past 24 hours on the WallStreetBets Reddit thread as a potential short-squeeze opportunity.

07:40 EDT Chalice Brands acquires Cannabliss retail stores from Acreage Holdings - Chalice Brands has entered into an asset purchase agreement and a services agreement effective September 16, 2021 to acquire four retail stores branded Cannabliss & Co. from Acreage Holdings, located in Portland, Eugene, and Springfield, Oregon for total consideration of $6.5 million or 0.8 times FY 2020 annualized revenue. With the Cannabliss acquisition, Chalice strengthens its customer base in the Oregon market, while also significantly increasing vertical margin contribution through the distribution of its Bald Peak flower, Chalice, Private Stash, RXO, and Elysium Fields branded products into the Cannabliss stores. The closing of the transaction is subject to approval by the OLCC and the satisfaction of other closing conditions. Transaction Highlights: Under the terms of the Asset Purchase Agreement, Chalice will acquire the assets of the four Cannabliss retail dispensaries for total consideration of $6.5 million, consisting of $250,000 cash payment at the time of signing, offset by working capital surplus of $500,000, plus a 10-month secured promissory note for $6.25 million carrying interest of 6% for the first five months, 10% for the remaining five months, if necessary. Under the terms of the Services Agreements, immediately upon signing, Chalice contracts to operate the retail stores including staffing, pricing, and procurement which allows Chalice to deploy its world class retail management best practices and immediately boost top line, bottom line, and restore lost market share as well as optimize vertical margin contribution. Cannabliss lost market share and momentum during the COVID crisis, providing the opportunity to turn around performance under the guidance of Chalice's leadership team and its retail expertise. Oregon dispensaries include two in Portland, one in Eugene, and one in Springfield. Two of the store locations are in buildings that are on the national registry of historic places - Sorority House in Eugene and Firestation 23 in Portland. The Firestation 23 location was the first adult use dispensary to open in the city of Portland and was Oregon's first medical marijuana dispensary. Chalice retail footprint increases from twelve to sixteen stores in Oregon, making this nearly a 130% increase in the current fiscal year. Cannabliss is expected to carry Chalice Brands products immediately upon commencement of services agreements providing the opportunity to increase total gross margins gradually from approximately 42% to at least 52% within a year. Vertical sales of Chalice branded products are expected to be approximately 25% of products sold within a year.

07:36 EDT Biogen announces results of CONVEY study of vixotrigine - Biogen announced positive topline results from its Phase 2 CONVEY study of vixotrigine, a non-opioid investigational oral pain drug being evaluated for the treatment of small fiber neuropathy. The CONVEY study 200 mg twice daily arm met its primary endpoint of change from baseline to week 12 of the double-blind period in mean average daily pain score. In this study, all participants who enrolled received the higher dos in an open-label portion which preceded the double-blind portion of the study. While the 350 mg twice daily arm did not meet the primary endpoint, it met statistical significance in the Patient Global Impression of Change at week 12, an important self-reported measure of a patient's overall improvement since with the start of the study. The totality of data from the vixotrigine program will inform potential doses for study in future Phase 3 clinical trials. There is a significant unmet need for non-opioid treatments for people suffering from chronic neuropathic pain. CONVEY was a Phase 2 placebo-controlled, double-blind, enriched enrollment, randomized withdrawal study that evaluated the efficacy and safety of vixotrigine in treating pain experienced by participants with confirmed idiopathic or diabetes mellitus-associated small fiber neuropathy. Vixotrigine 200 mg twice daily resulted in a statistically significant reduction in the mean average daily pain score versus placebo at week 12. Treatment effect was noted in participants with diabetes mellitus based on a subgroup analysis but was not evident in the smaller subgroup of patients with idiopathic SFN. The 200 mg dose also resulted in statistically significant improvement versus placebo on the mean worst daily pain score at week 12. Numeric advantage of 200 mg over placebo was observed in additional secondary endpoints, but these did not meet statistical significance. Vixotrigine 350 mg twice daily did not meet the primary endpoint of mean change in ADP at week 12. However, treatment with 350 mg vixotrigine resulted in a statistically significant increase in the proportion of participants who reported they were "very much improved" or "much improved" when compared to baseline, using the Patient Global Impression of Change questionnaire. In addition, numeric advantage of 350 mg over placebo was observed in some secondary endpoints but these did not meet statistical significance. Both doses of vixotrigine were generally well tolerated and the safety profile was consistent with previous studies of vixotrigine with no evidence of abuse potential. In the open-label period, common AEs were dizziness, headache, vertigo, and nausea. 5.3% of subjects discontinued the open-label part of the study due to adverse events; across the entire study the majority of the AEs were mild or moderate in severity.

07:32 EDT Intellia Therapeutics announces FDA acceptance of IND application for NTLA-5001 - Intellia Therapeutics announced that the U.S. Food and Drug Administration has accepted the investigational new drug application for NTLA-5001, the company's first wholly-owned ex vivo CRISPR genome editing candidate for the treatment of cancer. NTLA-5001 is an autologous T cell receptor-T cell therapy engineered to target the Wilms' Tumor antigen for the treatment of all genetic subtypes of acute myeloid leukemia. Intellia intends to initiate patient screening by year-end in a Phase 1/2a study evaluating NTLA-5001 in adults with persistent or recurrent AML who have previously received first-line therapy. "The FDA's acceptance of our IND for NTLA-5001 is an important milestone in our pursuit of developing advanced cell therapies utilizing Intellia's proprietary engineering platform to treat patients with cancer. NTLA-5001 is our first wholly-owned ex vivo candidate to enter the clinic, and we expect to initiate this first-in-human study in adults with AML by year-end. Our treatment strategy is to leverage CRISPR/Cas9 genome editing technology to create next-generation engineered immune cells with the potential to attack cancer cells more effectively and safely than previously developed cell therapies," said Intellia President and Chief Executive Officer John Leonard, M.D. The Phase 1/2a study will evaluate the safety, tolerability, cell kinetics and anti-tumor activity of a single dose of NTLA-5001 in adults who have detectable AML after having received standard first-line therapy. The study will contain a dose escalation and expansion phase, with up to 54 participants. Once a dose is identified in each arm, two expansion cohorts will be opened for further safety assessment. In addition to the U.S., Intellia has also submitted a regulatory application to the U.K. for NTLA-5001.

07:15 EDT Autolus Therapeutics receives planning approval for UK manufacturing facility - Autolus Therapeutics announced that planning approval has been granted to build the Company's new manufacturing facility in Stevenage, UK. The 70,000 square foot facility is being built by Merit Holdings Limited as general contractor for the Reef Group, who will lease the facility to Autolus. Global commercial launch capacity for obecabtagene autoleucel will initially be provided by the existing clinical trial manufacturing facility at The Cell and Gene Therapy Catapult facility, and will then move to the new Autolus facility which will allow for GMP capacity for approximately 2,000 batches a year initially, with scope to expand.

07:12 EDT Electric Last Mile Solutions announces opening of APOC - Electric Last Mile Solutions announced that it has officially opened its new Asia Pacific Operations Center, or APOC, in Shanghai, China. The establishment of APOC further expands ELMS' global footprint and will serve as a hub for supply chain and logistics management, engineering operations, project management and quality functions. The team in Shanghai will work closely with ELMS' suppliers and be fully integrated with the Company's global headquarters in Troy, Michigan. "Combined with our global team in Michigan, APOC will allow ELMS to improve supplier engagement, increase our speed to market and efficiently execute our unique business plan," stated James Taylor, ELMS CEO. "To support our aggressive growth plans, we fully expect APOC to exceed 100 employees by the end of the year." ELMS is set to begin production of its Urban Delivery Class 1 commercial EV later this month at its Mishawaka, Indiana production facility.

07:11 EDT Instil Bio presents subset analysis of patients from compassionate use study - Instil Bio announced that a subset analysis of treatment outcomes with unselected autologous tumor infiltrating lymphocytes in patients with checkpoint inhibitor-refractory advanced cutaneous melanoma was presented today at the 2021 European Society for Medical Oncology Congress, taking place virtually from September 16-21, 2021. Among the 12 patients featured in this subset analysis who had disease progression following treatment with a PD-1 inhibitor, all were also resistant to CTLA-4 inhibition with ipilimumab. Seven patients achieved an objective response, with 1 achieving a complete response. With a median duration of follow-up of 45.5 months, the median overall survival was 21.3 months with nearly half of patients experiencing long term survival. Side effects of treatment were largely transient, manageable with supportive care, and generally attributable to the lymphodepleting chemotherapy regimen and post-TIL high-dose IL-2 treatment. Outcomes in this highly treatment-refractory subgroup were similar to those observed in all 21 treated patients, with high response rates and an expected safety profile.

07:10 EDT Ion Geophysical receives grants to advance port decarbonization - ION Geophysical Corporation's Edinburgh-based Software group announced the company received a grant to advance port decarbonization through its climate-smart platform, Marlin SmartPort. The grant supports the UK's Ten Point Plan to address climate change and help achieve the country's net-zero emissions target by 2050. The Data-Led Emissions Management project is part of the Clean Maritime Demonstration Competition, funded by the UK Department for Transport and delivered in partnership with Innovate UK. The 6-month pilot study will validate whether vessel fuel usage and carbon dioxide emissions can be reliably estimated in and around ports using the International Maritime Organization global standard. "Today approximately 90% of goods are transported by sea and global shipping accounts for nearly 3% of global CO2 emissions," said Stuart Darling, Senior Vice President of ION's Software group. "Our technology is focused on creating high value information that drives smarter, safer management of the 5,000+ ports globally and the 50,000+ cargo vessels that transit between them. This grant enables us to continue advancing our maritime digitalization platform, Marlin SmartPort, which integrates systems and data to provide better real-time visibility and actionable intelligence to operate with just-in-time efficiency, minimizing fuel consumption and emissions. Our goal is to develop and validate fuel monitoring capabilities to start tracking and, ultimately, to reduce port-related shipping emissions. On behalf of ION, I would like to thank our project partners, Plymouth Marine Laboratory, who will supply the data, and the Offshore Renewable Energy Catapult, who will assist with the analysis."

07:09 EDT Phio Pharmaceuticals' Intasyl combination shows anti-tumor efficacy - Phio Pharmaceuticals announced results of a new study showing that local treatment in vivo with Intasyl can cure tumors and generate systemic tumor immunity that is both durable and tumor specific. These data were presented at the European Society of Medical Oncology Congress,. The study was performed to show the synergistic activity of co-targeting PD-1 and BRD4 with one Intasyl formulation in a preclinical in vivo hepatocellular carcinoma model. The results show that up to 83% of the animals treated with PH-3861 had a complete response when treated at low doses, namely doses suboptimal for monotherapy. This treatment induced a durable and specific systemic anti-tumor immune response, without requiring further treatment. Subcutaneous Hepa1-6 tumors in mice were treated with a murine version of dual targeting Intasyl PH-3861 by local administration to the tumor. All of the rechallenged mice previously cured by mPH-3861 were cured again without requiring further treatment. These data show that treatment with mPH-3861 provides a durable and systemic anti-tumor immune response that can combat tumor growth.

07:08 EDT Gilead says data evaluating Trodelvy in patients with TNBC show improvement - Gilead Sciences announced new data from the Phase 3 ASCENT study evaluating Trodelvy, sacituzumab govitecan-hziy, in patients with relapsed or refractory metastatic triple-negative breast cancer TNBC who received two or more prior systemic therapies, at least one of them for metastatic disease. In a retrospective subgroup analysis, Trodelvy improved progression-free survival PFS, overall survival OS and objective response rate ORR compared with chemotherapy chosen by the patients' physicians in patients who were not initially diagnosed with TNBC. The results were presented at the European Society of Medical Oncology Congress 2021 from September 16-21, 202 "In the metastatic stage of breast cancer, it is not uncommon for people to change from one subtype to another," said Javier Cortes, MD, Head of the International Breast Cancer Center (IBCC), Madrid and Barcelona, Spain. "Roughly one-third of patients with TNBC in the ASCENT study were not originally diagnosed with TNBC, and they still experienced a survival benefit with Trodelvy compared with chemotherapy. For treating physicians, this reinforces Trodelvy's efficacy in more complex patients." "Trodelvy is already transforming outcomes for patients with second-line or later metastatic TNBC," said Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Research, Gilead Sciences. "Gilead is committed to continued research that further defines the clinical profile of Trodelvy. As such, we are pleased that this sub-analysis in patients not initially diagnosed with TNBC demonstrated similarly strong overall survival, progression-free survival and response rates as were observed in the overall ASCENT study population."

07:06 EDT Axsome Therapeutics initiates SYMPHONY Phase 4 trial of AXS-12 in narcolepsy - Axsome Therapeutics enrolled the first patient in SYMPHONY, a Phase 3, randomized, double-blind, placebo-controlled trial of AXS-12 in patients with narcolepsy. AXS-12 is a novel, oral, potent, and highly selective norepinephrine reuptake inhibitor. Topline results from the SYMPHONY trial are anticipated in the first half of 2023. "The advancement of AXS-12 into Phase 3 testing for narcolepsy demonstrates Axsome's commitment to developing important new medicines for patients living with serious CNS conditions," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. "Narcolepsy impairs almost every aspect of a patient's life including cognitive, psychological, social, and emotional functioning. If successfully developed, AXS-12 may address multiple symptoms of this debilitating condition."

07:05 EDT BeyondSpring announc new data on plinabulin for its CIN prevention program - BeyondSpring Pharmaceuticals announced new positive data on plinabulin from its chemotherapy-induced neutropenia, or CIN, prevention program with three poster presentations at the European Society for Medical Oncology 2021 Congress taking place from September 16-21, 2021. Plinabulin, the Company's first-in-class lead asset, in combination with G-CSF for the prevention of chemotherapy-induced neutropenia is currently under U.S. and China regulatory review with an FDA PDUFA date of November 30, 2021. Poster: "Severe Neutropenia as a Population-Based Predictor for Adverse Clinical Outcome of Chemotherapy Induced Neutropenia." Correlations of exponential equations between rate of febrile neutropenia, duration of severe neutropenia and absolute neutrophil count nadir were statistically significant and in agreement with each other. Grade 4 neutropenia, or Gr4N, is a valid binary predictor of CIN outcomes, and a 65% Gr4N threshold depicts low vs. high CIN outcome risk.Poster: "Prediction of Febrile Neutropenia, Hospitalization Rates, and Infection Rates in Chemotherapy-Induced Neutropenia Patients Treated with the Plinabulin and Pegfilgrastim Combination using a Meta-Analysis-based Tool." In the PROTECTIVE-2 Phase 3 trial, the combination of plinabulin and pegfilgrastim had superior efficacy in preventing Gr4N versus pegfilgrastim alone; Gr4N of 68% in the combination vs. Gr4N of 86% for pegfilgrastim alone. The reduction in Gr4N frequency from 86% in pegfilgrastim alone to 68% in the combination is predicted to result in a statistically significant and clinically meaningful reduction) in key clinically relevant CIN outcomes including mean DSN, FN rate, mean ANC nadir, hospitalization rate and infection rate. Poster: "Impact of Adding Plinabulin to Pegfilgrastim for the Prevention of Chemotherapy Induced Neutropenia, on Patient Quality of Life" The physical wellbeing of patients receiving plinabulin and pegfilgrastim was significantly less impacted by TAC compared to those receiving pegfilgrastim alone. In addition, patients receiving plinabulin and pegfilgrastim recovered to their pre-chemotherapy physical wellbeing levels more rapidly and experienced less deterioration in their QoL over the duration of the 4-cycle trial.

07:04 EDT Bristol-Myers reports Opdivo combination meets Phase 3 RCC survival endpoint - Bristol Myers announced that Opdivo - nivolumab - plus Yervoy - ipilimumab - continued to demonstrate durable, long-term survival in the Phase 3 CheckMate -214 trial, with a five-year survival rate of 48% in patients with previously untreated advanced or metastatic renal cell carcinoma, or RCC. After a median follow-up of 67.7 months, Opdivo plus Yervoy maintained superior overall survival and response benefits versus sunitinib in both patients with intermediate- and poor-risk prognostic factors, the primary endpoint population, and across all randomized patients. In intermediate- and poor-risk patients, Opdivo plus Yervoy maintained treatment effects over five years, with ongoing improvements in OS and overall response rate, as well as in supportive endpoints. Median OS was 47.0 months for intermediate- and poor-risk patients treated with Opdivo plus Yervoy versus 26.6 months with sunitinib. ORR benefits were maintained with Opdivo plus Yervoy compared to sunitinib - 42% vs. 27%. The safety profile of Opdivo plus Yervoy was manageable, and no new safety signals emerged with extended follow-up. Patients who were alive three years after starting treatment with Opdivo plus Yervoy had an 81% probability of remaining alive for an additional two years, compared to 72% with sunitinib. Patients who responded to treatment with the combination and remained in response for three years had an 89% probability of remaining in response for two additional years vs. 63% with sunitinib.

07:03 EDT SOC Telemed, Ob Hospitalist Group announce nationwide partnership - SOC Telemed and Ob Hospitalist Group announced a collaboration combining OBHG's leading OB hospitalist programs with SOC Telemed's maternal-fetal medicine experts. The first hospital partner to go live with the new service in early August 2021 was Hendrick Medical Center in Abilene, Texas. The combined OB hospitalist/teleMFM offering is currently expanding to additional OBHG hospital partner sites nationwide. The new partnership enables patients to receive 24/7 onsite care from OBHG's skilled OB physicians and access to SOC Telemed's MFM physicians. When needed, OBHG clinicians can connect to MFM specialists in minutes for consultation to assist with the management of high-risk pregnancies or deliveries using SOC Telemed's telemedicine platform, Telemed IQ. The program is designed to complement the in-person physician care delivered by the OB hospitalists with care recommendations from the remote MFMs.

07:01 EDT Nabors Industries reiterates financial outlook for Q3 - Nabors Industries reiterated its financial outlook for the third quarter. The company published the original outlook in the July press release detailing results for second quarter. Anthony Petrello, Nabors Chairman, CEO and President, commented, "Our overall activity has developed as we expected in the third quarter with all of our segments continuing their strong performance. We are also encouraged by our cash generation quarter-to-date and expect once again to reduce our net debt as anticipated. We remain committed to improving the company's balance sheet leverage and we have completed another step. With the retirement of the 4.625% notes, our next pending maturity occurs in early 2023 and amounts to less than $25 million."

06:57 EDT Ryder, Embark Trucks announce partnership on transfer points - Ryder System and Embark Trucks announce a partnership aimed at launching a nationwide network of up to 100 Embark transfer points, where Ryder will provide yard operations, maintenance, and fleet management to support a seamless coast-to-coast autonomous network for Embark fleet partners. Through the partnership, Embark plans to establish a network of strategically located transfer points-where freight is moved from driverless long-haul trucks to driver-enabled trucks for first- and last-mile delivery. Ryder plans to serve as the transfer point operator, managing the logistical operations throughout the yard, performing pre- and post-trip inspections, and providing maintenance services for the vehicles as well as the autonomous hardware. Initially, the partnership will focus on developing select sites in key freight markets in California, Arizona, Texas, Georgia, Tennessee, and Florida, through which Embark plans to begin hauling loads in early 2022 in preparation for a larger commercial launch in 2024. Over the next five years, working with a network of real estate operators, the two companies aim to open as many as 100 Embark transfer points nationwide.

06:52 EDT Golden Minerals begins reverse circulation drill program at Rodeo mine in Mexico - Golden Minerals is pleased to announce additional assay results from 20 recently completed diamond drill holes and to announce it has commenced a reverse circulation drill program focusing on resource definition at its Rodeo gold-silver mine located in Durango State, Mexico. The reverse circulation program is being conducted by Major Drilling and will consist of 35 drill holes totaling approximately 2,500 meters. The program is designed to expand on the high-grade resource currently being mined and to drill several exploration targets located adjacent to the open pit. The reverse circulation drilling is expected to be completed in September. The company has reported assay results from an additional 20 holes, totaling 1,253 meters, from the ongoing diamond drilling program that is exploring for the continuation of Au-Ag mineralization to the north of the current mining area. Drilling has intersected several wide zones of disseminated gold mineralization and has identified several additional high-grade zones that appear to be hosted in a series of silicified structures running parallel to the high-grade gold zones currently being mined.

06:49 EDT BWX Technologies, Bayer partner to develop Actinium-225 - BWX Technologies (BWXT) announced that its BWXT Medical Ltd. subsidiary has entered into an agreement with Bayer AG (BAYRY) to develop Actinium-225 supply and further partnering opportunities on finished products as both companies broaden their respective commercialization strategies for targeted radionuclide therapies and other innovative products. Ac-225 is a highly powerful radioisotope used in targeted alpha therapies, an emerging class of radionuclide therapy for various tumors with a high unmet medical need, delivering alpha radiation directly to tumors either via its bone-seeking properties or by combining alpha radionuclides such as Ac-225 with specific tumor-seeking targeting vectors. BWXT Medical plans to utilize its deep relationships with strategic partners in irradiation services and development of Ac-225. Much like BWXT Medical's other products, processing and manufacturing would then be conducted at BWXT Medical facilities. Bayer and BWXT Medical have structured the evolution of their relationship to progress over stages, and the complete terms of the commercial agreements will be finalized at a later date.

06:39 EDT Aptinyx secures $50M growth capital credit facility from K2 HealthVentur - Aptinyx has entered into a $50M loan facility and security agreement with K2 HealthVentures. The funds will provide general growth capital as Aptinyx advances its late-stage clinical pipeline of novel NMDA modulators. Aptinyx will receive $15M after execution of the loan agreement from K2HV, with an option to draw down an additional $10M, which will support the future clinical development of multiple pipeline programs. Under the terms of the agreement, the remaining $25M is subject to the achievement of certain terms and conditions, including regulatory and developmental milestones.

06:31 EDT Shoe Carnival appoints Diane Randolph to Board of Directors - Shoe Carnival (SCVL) announced the appointment of Diane Randolph to its Board of Directors, effective immediately. Following the appointment of Randolph, the Board will be composed of seven directors, and five are independent. From 2014 to 2020, Randolph held the position of Chief Information Officer of U.S. beauty retailer, Ulta Beauty (ULTA).

06:15 EDT Molson Coors announces Topo Chico to expand nationwide in January 2022 - Molson Coors announced Topo Chico Hard Seltzer will officially expand product distribution nationwide starting January 2022.

06:04 EDT dMY Technology Group IV, Planet Labs announce upsized PIPE - Planet Labs and dMY Technology Group, Inc. IV announced that they have received a commitment for a $50M investment in dMY IV from Canada Pension Plan Investment Board. Together with CPP Investments, Cypress Point Investment Management participated in a co-investment. Planet recently entered into a definitive Merger Agreement with dMY IV to become a publicly traded company later this year. The commitments by CPP Investments and Cypress Point are on substantially similar terms as the $200M private placement investment initially announced on July 7, in conjunction with the Business Combination. The new commitments bring proceeds raised in the PIPE transaction to over $250M, which will satisfy the minimum cash closing condition of the Business Combination. These proceeds, along with over $345M in dMY IV's trust account, will be used to fund Planet's operations and support new and existing growth initiatives.

06:02 EDT UTStarcom signs strategic cooperation agreement with Zhongrui Technology - UTStarcom signed a strategic cooperation agreement with China Comservice Zhongrui Technology on September 8. The strategic cooperation between the two companies will focus on the development and production of software and hardware products of UTStarcom and Zhongrui Technology in the fields of blockchain, Internet of Things, cloud computing, big data, artificial intelligence, 5G + Industrial Internet, information security and others. Initial focus is going to be on the blockchain and 5G access/IoT devices and applications. Zhongrui Technology is a state-owned enterprise established in 1982 and affiliated to China Communications Services.

06:00 EDT Prudential to sell $31B PALAC block of legacy variable annuities to Fortitude Re - Prudential Financial and Fortitude Group Holdings, LLC, the parent company of Fortitude Re, on Wednesday announced that they have entered into a definitive agreement under which Prudential will sell a portion of its in-force legacy variable annuity block to Fortitude Re for a total transaction value of $2.2B. Under the terms of the agreement, Prudential will sell one of its stand-alone legal entity subsidiaries, Prudential Annuities Life Assurance Corporation, including PALAC's in-force annuity contracts, to Fortitude Re, for an all-cash purchase price of $1.5B, subject to certain adjustments at closing, plus a capital release to Prudential and an expected tax benefit. The PALAC block primarily consists of non-New York traditional variable annuities with guaranteed living benefits that were issued prior to 2011, which constitute approximately $31B or 17% of Prudential's total in-force individual annuity account values as of June 30, 2021. Prudential will continue to service and administer all contracts in the PALAC block following the transaction to ensure a consistent experience for customers. Prudential does not expect there to be any direct impact to employee head count as a result of the transaction. Prudential will retain its interest in all FlexGuard buffered annuity contracts and PALAC recently issued fixed and fixed indexed annuities through a reinsurance agreement with Fortitude Re and, subject to regulatory approvals, intends to offer those FlexGuard and other recent PALAC customers the option to replace the issuer of their contract with another Prudential subsidiary. The transaction, which is subject to regulatory approval and other customary closing conditions, is expected to close during the first half of 2022. Upon closing, Prudential anticipates a reduction to pre-tax annual adjusted operating income of approximately $290M. Proceeds from the transaction are expected to be used for general corporate purposes.

05:55 EDT Athenex presents data from paclitaxel with pembrolizumab study - Athenex announced the presentation of data from a Phase 1 study to assess the safety, tolerability, and activity of oral paclitaxel and encequidar in combination with pembrolizumab in patients with advanced solid malignancies. The data are being presented in a poster presentation at the European Society for Medical Oncology Virtual Congress, being held from September 16 to September 21. The primary objective for the dose escalation phase of the study was to determine the maximum tolerated dose, or MTD, and identify the recommended Phase 2 dose, or RP2D, of Oral Paclitaxel in combination with pembrolizumab in patients with advanced solid tumors. The dose escalation phase of the study enrolled 21 patients. Activity data were presented on 17 patients who were evaluable for a response, including eight NSCLC patients as well as patients with head and neck cancer, uveal melanoma, oesophageal cancer, colon cancer and bladder cancer. Four patients had partial response, 10 patients had stable disease, and three patients had progressive disease. The duration on treatment ranged from 9 to 676+ days. There were a total of 10 NSCLC patients enrolled, of which eight were evaluable for response. Four patients achieved partial response and four patients achieved stable disease. All had discontinued previous checkpoint inhibitor therapy due to progressive disease. MTD of the combination was not reached. The RP2D in combination with pembrolizumab was selected as Oral Paclitaxel 270 mg QD Days 1-3 for 2 weeks of a 3-week cycle. The study is proceeding to expansion cohorts and will enroll additional patients with NSCLC to further evaluate the safety and clinical activity of Oral Paclitaxel with pembrolizumab. The Phase 1 study is an open-label dose-escalation design study, to be followed by a 2-arm expansion cohort. The dose escalation utilized the "3+3" design and eligible patients had metastatic or unresectable solid tumors for which pembrolizumab is an FDA approved therapy. The Oral Paclitaxel dose range explored was 270-330mg administered for 2 days up to a maximum of five days per week x 2 weeks of a three-week cycle. Pembrolizumab 200mg IV was administered every three weeks. The primary objective for Part A of the study was to determine the maximum tolerated dose, or MTD, and identify the recommended Phase 2 dose of Oral Paclitaxel in combination with pembrolizumab in subjects with advanced solid tumors. Secondary objectives included safety and tolerability, the pharmacokinetics of paclitaxel, and preliminary anti-tumor activity. MTD and dose limiting toxicities were determined based on toxicities observed during the first 3-week cycle of treatment. Response was determined by CT scan evaluated by RECIST 1.1 every nine weeks. The Part B dose expansion phase will enroll subjects with NSCLC to further evaluate the activity, safety and tolerability of the study treatment.

05:48 EDT Leap Therapeutics presents data from first-line cohort of DisTinGuish study - Leap Therapeutics (LPTX) announced the presentation of updated data from the first-line cohort of the DisTinGuish study, a Phase 2a clinical trial evaluating Leap's anti-Dickkopf-1, or DKK1, antibody, DKN-01, in combination with tislelizumab, BeiGene's (BGNE) anti-PD-1 antibody, and chemotherapy, in patients with gastric or gastroesophageal junction cancer at the European Society for Medical Oncology Congress. The company will host a conference call on Friday, September 17 to discuss preliminary results from the study. The company announced initial data from the DisTinGuish study based on 25 G/GEJ patients enrolled in the trial that showed DKN-01 in combination with tislelizumab and chemotherapy as first-line therapy was well tolerated with compelling activity. The results presented at the ESMO Congress included additional patient data stratified by tumoral PD-L1 expression levels based on visually-estimated combined positive score, or vCPS, showing that objective clinical responses can be achieved from this combination regimen independently of PD-L1 expression. Among patients who received a full cycle of DKN-01 therapy, the ORR was 68.2%, with 90% ORR in DKK1-high patients and 56% in DKK1-low patients Response was independent of PD-L1 expression, and particularly strong in the less favorable to checkpoint inhibitor therapy, PD-L1 low, population. Among those patients with PD-L1-low expression, the ORR was 79%, with 100% in DKK1-high patients and 57% in DKK1-low patients . Among those patients with PD-L1-high expression, the ORR was 67%, with 75% ORR in DKK1-high patients and 50% in DKK1-low patients. DKK1 levels could not be determined in one patient who had PD-L1 expression data; however, the patient's PD-L1 expression level was determined to be low and the patient achieved a partial response. DKK1 expression and PD-L1 expression are not correlated Median duration of response and progression-free survival data are not yet mature, and patient follow-up continues. Twenty-five first-line patients were enrolled, and as of the cut-off date of the presentation, 15 patients had experienced a partial response, six patients had a best response of stable disease, one patient was non-evaluable for response and three patients were unable to complete a full cycle of DKN-01 therapy. Among the 21 patients that had RNAscope DKK1 expression available, 12 were DKK1-high and nine were DKK1-low. Among the 20 patients that had PD-L1 expression available, 14 were PD-L1 low vCPS less than 5 and six were PD-L1 high vCPS greater than 5.

05:36 EDT MacroGenics announces results from MAHOGANY clinical trial - MacroGenics announced results from Cohort A Part 1 of the Phase 2/3 MAHOGANY clinical trial of margetuximab. Margenza is approved in HER2+ metastatic breast cancer and is being investigated as a potential first-line treatment for patients with HER2+ gastric cancer, or GC, or gastroesophageal junction, or GEJ, cancer in combination with a checkpoint inhibitor, with or without chemotherapy. The dataset is available in a poster at the 2021 European Society for Medical Oncology Virtual Conference taking place September 16-21. The efficacy data and safety cutoff dates were July 19 and August 3, respectively. In Cohort A Parts 1 and 2, the efficacy and safety of combining margetuximab and retifanlimab is planned to be evaluated in approximately 100 patients whose tumors are HER2+ at the 3+ level by immunohistochemical staining, PD-L1+ and non-microsatellite instability-high. A pre-specified interim analysis assessing efficacy and safety was conducted on the first 40 non-MSI-H patients enrolled in Part 1. These data support advancement to Part 2 with plans to enroll approximately 60 additional response-evaluable non-MSI-H patients. A total of 43 HER2 3+ and PD-L1+ patients were enrolled in Cohort A Part 1 and received margetuximab 15 mg/kg plus retifanlimab 375 mg/kg administered intravenously every three weeks. Twenty-five patients had gastric cancer and 18 patients had gastroesophageal junction cancer; 36 patients had metastatic disease at study entry. Anti-tumor activity was observed in patients treated with margetuximab plus retifanlimab in MAHOGANY Cohort A after the first scan. Tumor shrinkage was observed in 32 of 41 patients with at least one post-baseline target lesion measurement. Twenty-one of 40 response-evaluable patients achieved an objective response, including four confirmed complete responses and 17 confirmed partial responses. The number of confirmed responders by independent assessment exceeded the prespecified futility boundary for the trial, and enrollment is proceeding to Cohort A Part 2. Disease control was achieved in 29 of 40 patients and the median duration of response was 10.3 months. Median progression-free survival, or PFS, was 6.4 months by independent assessment; median overall survival, or OS, was not yet reached. At both 12 and 18 months, OS was 85%. Antitumor activity was comparable to historical data from the experimental arm of the Trastuzumab for Gastric Cancer study of 47%; median duration of response of 6.9 months and initial data from the control arm of the KEYNOTE-811 study. The safety analysis of all 43 patients treated with margetuximab plus retifanlimab suggests the combination was well tolerated in the study population. The most common TRAEs were fatigue, infusion-related reaction, rash, diarrhea and pruritus. A total of nine Grade 3 TRAEs were reported in eight patients; no Grade 4 TRAEs were observed. Eight serious TRAEs were reported in seven patients. Infusion-related reactions considered as adverse events of special interest occurred in six patients. Treatment-emergent AEs of Grade 3 occurred in 18 of 43 patients of patients. Three of 43 patients discontinued therapy due to immune-related AEs: renal dysfunction, hepatitis and diabetic ketoacidosis; no AEs led to death. Safety data from MAHOGANY compare favorably to the experimental arm of ToGA in which overall Grade 3-4 AEs were 68% and the treatment-related mortality was 3%. Initial results from KEYNOTE-811 data presented at the 2021 ASCO Annual Meeting indicated that AEs of Grade 3-5 occurred in 57.1% of patients in the experimental arm and in 57.4% of patients in the control arm, AEs leading to death occurred in 3.2% vs 4.6%, and AEs leading to discontinuation of any study drug occurred in 24.4% vs 25.9% of patients, respectively. Despite limitations of cross-study comparisons, regimens containing chemotherapy may have clinically relevant safety differences compared to the chemotherapy-free regimen in MAHOGANY Cohort A.

05:16 EDT FinVolution Group to be added to FTSE Russel Indexes - FinVolution Group announced that it will be added to the FTSE Global Equity Index Series, or GEIS, including the FTSE Global All Cap Index and FTSE Global Small Cap Index, effective after the close of business on Friday, September 17.

05:09 EDT Gogoro to become public through Poema Global business combination - Gogoro and Poema Global (PPGH), a publicly traded special purpose acquisition company, announced a definitive agreement for a business combination that would result in Gogoro becoming a publicly listed company. The combined company will focus on accelerating the global expansion of Gogoro's subscription-based battery swapping service along with its electric vehicle and component sales business. Upon the transaction closing, the combined company will be named Gogoro and will be listed on the Nasdaq under the ticker symbol (GGR). As part of its growth strategy, Gogoro will be introducing its battery swapping in China in late 2021, and is partnering with Yadea, an electric two-wheel maker, and Dachangjiang Group, a gas-powered two-wheel maker in China. The company has also announced a joint venture with Hero MotoCorp, a two-wheel vehicle maker in India, to build its battery swapping ecosystem in India. In addition, Gogoro has established partnerships with other companies in two-wheel mobility, including Yamaha, Tailing eReady, AeonMotor, PGO and CMC eMOVING. The Gogoro-Poema Global business combination sets Gogoro's enterprise value at $2.35B. The business combination is expected to provide approximately $550M in proceeds to Gogoro's balance sheet including an oversubscribed PIPE over $250M and $345M currently held in trust by Poema Global. The PIPE is backed by strategic partners, and new and existing financial investors. Current Gogoro shareholders are rolling 100% of their equity and will hold majority ownership of the combined company at closing. Cash proceeds raised in connection with the transaction will primarily be used to fund geographic expansion and operations, continued research and development, and for general corporate purposes. The boards of directors of both Poema Global and Gogoro have approved the proposed transaction. Completion of the proposed transaction is subject to the approval of Poema Global and Gogoro shareholders and other customary closing conditions, including a registration statement being declared effective by the U.S. Securities and Exchange Commission. The transaction is expected to be completed in Q1 of 2022.