Stockwinners Market Radar for September 20, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:46 EDT HCA Healthcare to buy five Utah hospitals from Steward Health Care - HCA Healthcare and Steward Health Care announced the signing of a definitive agreement for HCA Healthcare to acquire the operations of Steward Health Care's five Utah hospitals. HCA Healthcare also entered into an agreement to lease the related real estate from its owner following the expected closing. The hospitals will become part of HCA Healthcare's Mountain Division, which includes 11 hospitals in Utah, Idaho and Alaska.

19:03 EDT Amgen wins patent case on Otezla - Amgen "announced that the U.S. District Court for the District of New Jersey has upheld patents that protect Amgen's psoriasis therapy Otezla in a patent infringement lawsuit against Sandoz and Zydus Pharmaceuticals, Inc. The asserted patents claim apremilast as a composition of matter, methods of treating psoriasis with apremilast, and crystalline forms of apremilast. The court found infringement and upheld the validity of four patents - three against each defendant -- but ruled against Amgen on claims in U.S. Patent No. 10,092,541 covering methods of treating psoriasis with apremilast according to a specific dosing schedule. Today's decision will prevent Sandoz and Zydus from making, using, selling, offering to sell, or importing each of their generic versions of Otezla until expiration of the COM patent, U.S. Patent No. 7,427,638, in Feb. 2028. The decision comes after the New Jersey court held a bench trial in June 2021. Prior to trial, Sandoz acknowledged that its generic version of Otezla infringes eight claims in U.S. Patent Nos. 7,427,638, 7,893,101, 8,455,536, and 10,092,541, and Zydus acknowledged that its generic version of Otezla infringes eight claims in U.S. Patent Nos. 7,427,638, 8,093,283, 8,455,536, and 10,092,541, leaving only the issues of whether Zydus's generic version of Otezla infringes U.S. Patent No. 7,893,101 and the validity of the asserted patent claims to be addressed by the court."

18:24 EDT Airbnb CEO: Our model is very adaptable - In an interview on CNBC's Mad Money, Brian Chesky said 55% of Airbnb's hosts are women. The company's model is incredibly adaptable and it's always innovating, he noted. It's currently in over 100,000 communities. Airbnb used to be an alternative way to travel, but now it's becoming the default option, he added.

17:27 EDT Raytheon Technologies awarded $140.37M Navy contract modification - Raytheon Technologies is awarded a $140.37M fixed-price-incentive-fee, firm-fixed-price modification to a previously awarded contract. This modification adds scope to procure 36 AN/APG-79(V)4 radar systems in support of radar integration into the C/F-18A aircraft for the government of Canada. Additionally, this modification provides supplies and support to include software, obsolescence management, engineering support and associated technical, financial, and administrative data in support of AN/APG-79(V)4 radar integration effort. Work is expected to be completed in March 2024. Foreign Military Sales funds in the amount of $140.37M will be obligated at time of award, none of which will expire at the end of the current fiscal year. The Naval Air Systems Command is the contracting activity.

17:06 EDT BlackSky names J.R. Riordan chief revenue officer - BlackSky Technology announced that J.R. Riordan will be its Chief Revenue Officer effective September 20, 2021. Riordan is a former military strategist and policy expert with deep experience in the space and geospatial intelligence markets. He will be based in BlackSky's headquarters in Herndon, VA. and will be responsible for overseeing revenue operations, strategic partnerships and sales activities. "With a professional background in both defense and geospatial intelligence, J.R. will be an outstanding addition to BlackSky's expanded executive leadership team," said Brian E. O'Toole, CEO of BlackSky. "As our chief revenue officer, J.R. will play a pivotal role in building and sustaining our customer pipeline and strengthening our business development operations so that we can deliver first-to-know insights to more customers around the globe."

17:01 EDT Root names Daniel Rosenthal as COO and Chief Revenue Officer - Root "announced that Daniel Rosenthal has been appointed the company's first Chief Revenue and Operating Officer. As the company's Chief Revenue and Operating Officer, Rosenthal will have responsibility for functions aimed at driving revenue and streamlining operations within the business. In this new role, Dan will oversee performance marketing and growth, corporate strategy, business development, and insurance, including underwriting and pricing initiatives."

17:01 EDT Seagen, Genmab announce FDA accelerated approval for TIVDAK - Seagen (SGEN) and Genmab (GMAB) announced that the U.S. Food and Drug Administration has granted accelerated approval to TIVDAK, the first and only approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is approved under the FDA's Accelerated Approval Program based on tumor response and the durability of the response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. "Once recurrent or metastatic cervical cancer progresses, there is a need for more options for these patients," said Robert L. Coleman, M.D., Chief Scientific Officer, US Oncology Research and lead investigator of the innovaTV 204 clinical trial. "This is an important development for patients with recurrent or metastatic cervical cancer."

16:58 EDT ConocoPhillips to improve Scope 1, 2 GHG emissions intensity reduction targets - The company announced it will improve its Scope 1 and 2 GHG emissions intensity reduction targets. The prior 2030 reduction target of 35%-45% on a gross operated basis will be increased to 40%-50%, versus a 2016 baseline, on both a net equity and gross operated basis.

16:55 EDT Marten Transport director buys 15K shares of common stock - In a regulatory filing, Marten Transport disclosed that director Jerry Bauer bought 15K shares of common stock on September 20th in a total transaction size of $226K.

16:37 EDT Shell to sell Permian interest to ConocoPhillips for $9.5B - Shell Enterprises LLC, a subsidiary of Royal Dutch Shell (RDS.A), has reached an agreement for the sale of its Permian business to ConocoPhillips (COP), a shales developer in the basin, for $9.5B in cash. The transaction will transfer all of Shell's interest in the Permian to ConocoPhillips, subject to regulatory approvals. Shell's Upstream business plays a critical role in the Powering Progress strategy through a more focused, competitive and resilient portfolio that provides the energy the world needs today whilst funding shareholder distributions as well as the energy transition. The cash proceeds from this transaction will be used to fund $7B in additional shareholder distributions after closing, with the remainder used for further strengthening of the balance sheet. These distributions will be in addition to our shareholder distributions in the range of 20-30% of cash flow from operations. The effective date of the transaction is July 1, 2021 with closing expected in Q4 2021. "After reviewing multiple strategies and portfolio options for our Permian assets, this transaction with ConocoPhillips emerged as a very compelling value proposition," said Wael Sawan, Upstream Director. "This decision once again reflects our focus on value over volumes as well as disciplined stewardship of capital. This transaction, made possible by the Permian team's outstanding operational performance, provides excellent value to our shareholders through accelerating cash delivery and additional distributions."

16:34 EDT Lennar reports Q3 deliveries of 15,199 homes, up 10% - Reports Q3: New orders of 16,277 homes, up 5%; New orders dollar value of $7.5B, up 19%; Backlog of 25,819 homes, up 31%; backlog dollar value of $12B, up 52%.

16:31 EDT Conformis cuts Q3 product revenue view to $13.7M-$14.3M from $15.5M-$16.5M - Conformis provided an update of its third quarter revenue performance expectations in advance of the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit. The company has experienced higher than expected levels of deferred and rescheduled knee and hip procedures as a result of the surge in COVID-19 cases associated with the Delta variant. Accordingly, the company has updated its revenue outlook for the third quarter. Conformis now expects product revenue for the quarter to be approximately $13.7 million to $14.3 million. This compares to the $15.5 million to $16.5 million projection announced on August 4, 2021. "Over the last four weeks, we have experienced heightened levels of rescheduled and deferred procedures due to the rise of cases of COVID-19 and the Delta variant. Despite this increased headwind, we remain confident in our growth plan for 2022 and beyond. The recent additions to our product portfolio, the Identity Imprint knee and the products associated with our partnership with Stryker, have us well positioned as we execute our growth strategy. Our team continues to work with our provider network to get needed procedures scheduled and performed so our patients can reclaim living without pain when walking or other daily activities."

16:21 EDT Herc Holdings raises FY21 adjusted EBITDA view to $840M-$870M from $870M-$890M - Backs FY21 net rental equipment capex view of $500M-$550M. Initiates FY22 adjusted EBITDA view of $1.05B-$1.15B. The company also "outlined new strategic initiatives and set a three-year organic rental revenue goal of 12% to 15% compound annual growth from the midpoints of fiscal years 2021 through 2024. It also established an organic adjusted EBITDA goal of 17% to 20% on the same basis." CEO Larry Silber says: "We are pleased with the progress we have made over the last five years as an independently traded public company and are now shifting into high gear to accelerate our growth and return to shareholders," said Larry Silber, president and chief executive officer. "We have strong momentum and intend to invest in new locations and add to our fleet to enhance our urban density, while improving operating leverage and scale. We intend to increase market share through both organic growth and mergers and acquisitions. As we move into the next phase of our journey, we are committing to a capital allocation plan that balances our investment growth options between organic and acquisition growth. We also intend to enhance our returns to shareholders through the establishment of a quarterly dividend. We are well-positioned to execute our strategy and deliver value to all of our stakeholders."

16:19 EDT Willdan Group awarded $21.2M contract from City of Dublin, California - Willdan Group announced that it has been selected by the City of Dublin, California, to implement citywide energy efficiency, infrastructure, resiliency, and smart-city upgrades. Through this comprehensive $21.2M contract, Willdan will perform project engineering, development, construction, commissioning, and savings measurement and verification at over 20 sites across the City, including the deployment of distributed energy resources at 10 sites. The projects are estimated to complete construction within the next 18-24 months, and Willdan will support three years of operations and maintenance once the projects are in service. Ten sites will receive additional solar capacity, totaling 1.4 MW-DC capacity, and four of the sites will be paired with battery storage to support power resiliency during extreme weather events or heavy demands on the local power grid. Two locations will receive an additional 22 electric vehicle chargers to serve public-use and police fleet vehicles.

16:18 EDT Aprea Therapeutics presents data from phase 1/2 trial of APR-246 in solid tumors - The company states: "Aprea Therapeutics presented data at the European Society of Medical Oncology Congress 2021 from its Phase I/II clinical trial in advanced solid tumors. The trial is evaluating the safety and efficacy of eprenetapopt in combination with pembrolizumab. As of the July 31, 2021 data cutoff, 33 patients were enrolled on study and 31 had initiated treatment. The Phase I safety lead-in part was a dose de-escalation design and no dose-limiting toxicities were reported in the 6 enrolled patients. A Phase II expansion part was initiated and, as of the data cutoff, has enrolled 3 patients in the gastric/GEJ cancer, 3 in the bladder/urothelial cancer and 19 in the non-small cell lung cancer cohorts. Patients in the NSCLC Phase II cohort were required to have prior exposure to a PD-1 or PD-L1 inhibitor. Across all patients, 25 had a mutation in the TP53 gene. The trial continues to enroll and treat patients and exploratory studies involving analyses of patient-derived immune cell populations are ongoing. In the bladder/urothelial cohort, 1 patient with locally advanced TP53 mutant high-grade transitional cell bladder cancer had achieved complete remission by RECIST criteria at the first response assessment at 9 weeks. In the NSCLC cohort, 2 patients with TP53 mutant squamous NSCLC had reductions in target lesions of 26.7% and 8.2%, respectively, from baseline by RECIST criteria at the first response assessment at 9 weeks. Adverse events, regardless of causality, were mostly grade 1/2... One patient experienced a fatal adverse event of disease progression which was assessed by an investigator as not related to study treatment, and one patient experienced adverse events of fatigue, dyspnea and maculo-papular rash leading to discontinuation of eprenetapopt."

16:16 EDT APA Corp. raises quarterly dividend to 6.25c per share - The dividend on APA common shares is payable November 22 to stockholders of record on October 22. On an annualized basis, the dividend increases to 25c per share, up 150% from the previous annualized level of 10c per share.

16:15 EDT FedEx Express, FedEx Ground, and FedEx Freight to increase shipping rates - The company states: "FedEx Express, FedEx Ground, and FedEx Freight, subsidiaries of FedEx Corp., will increase shipping rates on January 3, 2022. FedEx Express shipping rates will increase by an average of 5.9% for U.S. domestic, U.S. export, and U.S. import services. FedEx Ground and FedEx Home Delivery shipping rates will increase by an average of 5.9%. FedEx Ground Economy shipping rates will also increase. FedEx Freight shipping rates will increase by an average of 5.9% for customers who use FXF PZONE and FXF EZONE, and by 7.9% for customers who use FXF 1000 and 501. This change applies to shipments within the U.S. and between the contiguous U.S. and Canada. FedEx Freight shipping rates will also increase for shipments within Canada, within Mexico, and between the contiguous U.S. and Mexico. These changes reflect incremental costs associated with the challenging operating environment, while enabling FedEx to continue investing in service enhancement, fleet maintenance, technology innovations, and other areas to serve customers more effectively and efficiently. Beginning January 3, 2022, FedEx will offer customers who ship internationally an additional option for time-definite deliveries in one to three business days. With the new FedEx International Priority Express service, customers will be able to schedule delivery by noon to select destinations. Early morning delivery will continue to be available through the FedEx International First service and end of day delivery to more than 220 countries will continue to be offered through the FedEx International Priority service."

16:12 EDT Sportradar announces Michael Jordan as special advisor to board - Sportradar announced that Michael Jordan, NBA legend and early Sportradar investor, will serve as a special advisor to Sportradar's board, while also increasing his investment in the company, effective immediately. In his new advisory position, Jordan will provide the board and management with guidance and strategic counsel, with a focus on the U.S. market, product development, marketing activities and other business initiatives. On September 14, Jordan joined Sportradar's directors, executive team, lead investors and guests in the Nasdaq opening bell ringing ceremony.

16:11 EDT Great Elm acquires majority interest in Lenders Funding for $7.25M - Great Elm Capital announced that it has acquired a majority equity interest in Lenders Funding a private funding and risk sharing source for factors and asset-based lenders GECC is purchasing a majority ownership position in Lenders Funding for $7.25M, consisting of $4M in cash and $3.25M in GECC shares issued at GECC's net asset value. In connection with the transaction, GECC will also issue to Lenders Funding $10M of additional GECC shares at NAV in exchange for a subordinated note in an equal principal amount. The proceeds from the transaction will be retained by Lenders Funding to help support the growth of the business. Peter A. Reed, GECC's Chief Executive Officer, stated, "We are pleased to announce the acquisition of a majority interest in Lenders Funding as we continue to weight our portfolio more heavily toward specialty finance. Lenders Funding has an excellent, long-term track record of profitably growing its business while maintaining a very strong underwriting culture. We are excited to partner with Bob, a well-known and highly regarded decision maker in asset-based lending. This transaction gives us additional access to proprietary overflow opportunities as well as visibility into the specialty finance market through the relationships with the many businesses to which Lenders Funding provides capital. We look forward to supporting Lenders Funding's growth and expanding our partnership over time."

16:10 EDT Alcoa plans restart of aluminum smelting capacity at Alumar in Brazil - Alcoa announced that it plans to restart 268,000 metric tons per year of aluminum capacity at the Alumar smelter in Sao Luis, Brazil, which has been fully curtailed since 2015. The process to restart the idle capacity will begin immediately. The first molten metal is expected in the second quarter of 2022, and the full 268,000 mtpy of capacity is expected to be operational in the fourth quarter of 2022. By 2024, the Alumar smelter will be powered with 100 percent renewable energy. The Alumar smelter restart will involve the hiring of more than 750 employees and will add to the 850 direct employees at the site's co-located alumina refinery. The cost of the restart is anticipated to be approximately $75 million, including approximately $10 million in capital expenses. Restart expenses expected to be incurred in the fourth quarter of 2021 are estimated to be between $15 million and $20 million pre-tax ($10 million and $13 million after-tax), or $0.05 and $0.07 per share. With this planned restart, Alcoa will have approximately 80 percent of its 2.99 million metric tons of global aluminum smelting capacity operating.

16:06 EDT EDP Renewables, TC Energy execute PPA to add 297MW Alberta wind farm - EDP Renewables, through its fully owned subsidiary EDP Renewables Canada , and TC Energy Corporation have executed a 15-year power purchase agreement, PPA for 100 percent of the output of the 297-megawatt Sharp Hills Wind Farm, located in the Special Areas municipality near the hamlets of Sedalia and New Bridgen, in the province of Alberta. The PPA will enable the continued development and eventual construction and operations of the wind farm, subject to customary regulatory approvals and conditions. The 297-MW Sharp Hills Wind Farm is anticipated to be operational in 2023 and will deliver economic benefits to the local project communities and the province of Alberta in the form of payments to local landowners and property tax revenue to the Special Area Board. Sharp Hills will also contribute to the increase in money spent at businesses in the vicinity of the wind farm. The project will create jobs with approximately 300 employment opportunities during the wind farm's construction and 15-20 permanent, local jobs during the project's operational life. The Sharp Hills Wind Farm will also generate enough electricity to annually power the equivalent of more than 164,000 average Alberta homes and will save approximately two billion litres of water per year. "I want to commend TC Energy and EDP Renewables for their commitment to diversifying Alberta's energy mix. Our province continues to experience significant investment growth in market-based renewable energy as a result of our commitment to an openly competitive electricity market. As a result, Albertans can count on new investments to power our economy while lowering emissions for decades to come," said Dale Nally, Associate Minister of Natural Gas and Electricity. "This agreement, which is Alberta's largest power purchase agreement for wind, is an important step as TC Energy continues to build its renewable energy portfolio," said Corey Hessen, TC Energy's Senior Vice President and President, Power and Storage. "This wind project, added to recent agreements in East Strathmore and Claresholm, gives us the capability to offer a variety of renewable energy solutions to Alberta customers. TC Energy is focused on our own decarbonization efforts as well as being the provider of choice for carbon-free energy to the North America industrial, oil, and natural gas sectors."

16:06 EDT SmileDirectClub to launch in France in Q4 - SmileDirectClub announced its plan to launch in France in the beginning of Q4. The company will introduce its clear aligners, telehealth platform and whitening system at its first France SmileShop in Paris, with additional locations to follow. This marks the company's entry into its seventh European country as it pursues the global market opportunity for its oral care products.

16:05 EDT Lucira Health announces Tony Allen as COO - Lucira Health (LHDX) announced operations expert Tony Allen has joined the company as COO. Allen comes to Lucira with 25 years' experience in operations and management. Most recently, he was VP and head of global internal manufacturing at Ortho-Clinical Diagnostics (OCDX), an in vitro diagnostics company.

16:01 EDT CBRE Group commits to net zero carbon emissions by 2040 - CBRE Group announced its commitment to achieve net zero carbon emissions by 2040. This commitment encompasses carbon emissions from CBRE's own operations and the properties it manages for investors and occupiers, as well as indirect supply chain emissions. "As the world's largest manager of commercial real estate, we have a special obligation to help the world address the many challenges posed by the warming planet," said Bob Sulentic, CBRE's president and chief executive officer. "CBRE is deeply committed to doing our part and to working with our clients and across our vast global supply chain to help achieve net zero emissions as quickly as possible. This is an essential element of our commitment to the communities in which we operate." As a part of its 2040 net-zero emissions strategy, CBRE today signed The Climate Pledge, a commitment to achieving net-zero carbon 10 years ahead of the goal stated in the Paris Agreement. The Climate Pledge, co-founded by Amazon and Global Optimism, forms a cross-sector community of companies and organizations committed to net zero carbon by 2040, working together to take action to address the climate crisis and solve the challenges of decarbonizing our economy.

15:31 EDT Twitter investigating possible irregularity for Twitter API - Twitter states on its status page: "The Twitter API team has identified a possible system irregularity currently affecting all Twitter API endpoints. The presence and scope of any customer impact has not been determined at this time, but we will provide an update as soon as we know more." Reference Link

14:02 EDT Amazon announces opening of first fullfillment center in North Dakota - Amazon's employees at the company's new fulfillment center in Fargo, North Dakota started work within the new one million-plus square foot facility on Sunday, Sept. 19, the company announced. "The new center is the largest structure in the State of North Dakota in terms of square footage and will be the workplace of hundreds of associates in the months and years ahead... In non-sortable fulfillment centers, like the new facility in Fargo, associates pick, pack, and ship bulky or larger-sized customer items such as patio furniture, outdoor equipment, or rugs. Amazon's first investment in the state was a delivery station in West Fargo, which is still operational and thriving," the company stated.

13:48 EDT Neogen acquires companion animal health company CAPInnoVet - Neogen announced that it has acquired Atlanta-based CAPInnoVet, a companion animal health company that provides pet medications to the veterinary market. CAPInnoVet will integrate into Neogen's Animal Safety business segment, which includes veterinary instruments, pharmaceuticals, vaccines, and diagnostic products. "The acquisition of CAPInnoVet provides Neogen a strategic pathway into the parasiticide market and naturally aligns within our Animal Safety business segment. We are excited for the team at CAPInnoVet to join the Neogen family," said Doug Jones, Neogen's Chief Commercial Officer. Terms of the agreement were not disclosed.

13:31 EDT Fannie Mae to enter into new credit risk transfer transactions in Q4 - Fannie Mae announced its intention to enter into new credit risk transfer transactions in Q4 of 2021. The company expects to transfer mortgage credit risk via its Connecticut Avenue Securities and Credit Insurance Risk Transfer programs.

13:25 EDT Vtex, AWS form multiyear collaboration agreement to create DTC solution - VTEX (VTEX) announced a multi-year agreement with Amazon Web Services (AMZN) to create a new direct-to-consumer solution that gives large enterprises-particularly global consumer packaged goods brands-the ability to quickly and easily launch e-commerce sites and experiences to sell directly to consumers, the companies said in a statement. The new DTC Launchpad solution, powered by VTEX on AWS, will combine AWS machine learning services, including Amazon Forecast and Amazon Personalize, and VTEX e-commerce, marketplace, and order management capabilities with logistics and distribution operations provided through Amazon's global Multi-Channel Fulfillment to create an end-to-end DTC solution.

13:08 EDT Facebook's Oculus announces launch of music videos in Oculus TV - Facebook's (FB) Oculus stated in a blog post: "Last year, we introduced official music videos on Facebook, giving people a new way to connect with the music they love and discover new favorites. Today, we're excited to roll out that same premium content in Oculus TV on the Oculus Quest Platform. We're launching in the US in partnership with Sony Music Group, Universal Music Group, Warner Music Group, Merlin, BMG, Kobalt, and more." Reference Link

12:29 EDT Wynn Resorts down after Jim Chanos says stock worth in $40s - Jim Chanos of Kynikos Associates, while speaking on CNBC, said he's short shares of Wynn Resorts and that the stock should be trading in the $40s. In midday trading Wynn is down 3% to $80.51. Chanos said Wynn's U.S. casinos are currently being valued at 20 times estimated 2022 EBITDA, which is too high. He also highlighted the slowdown in Macau traffic and the company's debt levels.

12:23 EDT Wynn Resorts shares should be trading in $40s, Jim Chanos says - Jim Chanos of Kynikos Associates is speaking on CNBC.

12:22 EDT Chanos says short Wynn Resorts on debt, Macau exposure - Jim Chanos of Kynikos Associates is speaking on CNBC.

12:14 EDT Chanos says short some large financial institutions in Hong Kong - Jim Chanos of Kynikos Associates is speaking on CNBC.

12:11 EDT Medtronic recalling Pipeline Flex Embolization Device, FDA says - The FDA announced that Medtronic is recalling the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk of the delivery system's wire and tubes fracturing and breaking off when the system is being used to place, retrieve, or move the stent inside a patient. There have been 59 reported device malfunctions, 10 serious injuries, and two deaths related to this recall, the agency noted. The FDA has identified this as a Class I recall, the most serious type of recall. Reference Link

12:00 EDT Krispy Kreme to be added to Russell 2000 Index - Krispy Kreme announced that it will be added to the Russell 2000 Index on September 20, 2021. This is part of planned third quarter IPO additions to the Russell US Indexes. "Krispy Kreme's inclusion in the Russell 2000 is a meaningful milestone following the successful completion of our IPO in July and is a reflection of our ongoing growth," said Mike Tattersfield, CEO of Krispy Kreme. "We continue to deliver on the strength of the Krispy Kreme brand and our omnichannel strategy around the world, and this is another testament to that fact."

12:00 EDT Nam Tai Property falls -22.9% - Nam Tai Property is down -22.9%, or -$6.43 to $21.65.

12:00 EDT Vicarious Surgical rises 9.8% - Vicarious Surgical is up 9.8%, or $1.13 to $12.70.

11:43 EDT Coinbase shelves plans to launch crypto lending program - Coinbase said in a blog post Friday: "As we continue our work to seek regulatory clarity for the crypto industry as a whole, we've made the difficult decision not to launch the USDC APY program...We have also discontinued the waitlist for this program as we turn our work to what comes next. We had hundreds of thousands of customers from across the country sign up and we want to thank you all for your interest. We will not stop looking for ways to bring innovative, trusted programs and products to our customers." The program was designed for users to earn interest on USD Coin, with rates more than 50 times the national average of a traditional savings account. Shares of Coinbase are down 5% to $233.23 after Bloomberg uncovered Friday's blog post update in late morning trading. Reference Link

11:38 EDT Exelixis announces results from Phase 3 COSMIC-311 trial of CABOMETYX - Exelixis announced final results from the phase 3 COSMIC-311 pivotal trial of CABOMETYX in patients with previously treated radioactive iodine-refractory differentiated thyroid cancer. Following a previous announcement that the trial met one of the two primary endpoints of significant improvement versus placebo in progression-free survival assessed by blinded independent radiology committee, the results of the final analysis are being presented during the Mini Oral Session - NETs and Endocrine Tumours at 5:30 p.m. CEST on Monday, September 20 at the 2021 European Society of Medical Oncology Congress . At a median follow-up of 10.1 months, the significant improvement in PFS with CABOMETYX was maintained, with consistent benefit in subgroups based on prior treatment. At a median follow-up of 10.1 months, CABOMETYX reduced the risk of disease progression or death versus placebo in the intent-to-treat population. Median PFS as assessed by BIRC was 11.0 months for patients treated with CABOMETYX compared with 1.9 months for patients treated with placebo. Subgroup analyses demonstrated that CABOMETYX improved PFS versus placebo irrespective of prior exposure to lenvatinib and/or sorafenib: Prior sorafenib/no lenvatinib: median PFS was 16.6 months for patients treated with CABOMETYX compared with 3.2 months for placebo. Prior lenvatinib/no sorafenib: median PFS was 5.8 months for patients treated with CABOMETYX compared with 1.9 months for placebo. Prior sorafenib and lenvatinib: median PFS was 7.6 months for patients treated with CABOMETYX compared with 1.9 months for placebo.An updated analysis for the primary endpoint of objective response rate as assessed by BIRC in the ITT population favored CABOMETYX at 11%, including one complete response, versus 0% for placebo. Median overall survival, an additional endpoint, was 19.4 months for patients treated with CABOMETYX and not estimable for patients treated with placebo. The safety profile was consistent with that previously observed for CABOMETYX, and adverse events were managed with dose modifications. The discontinuation rate due to treatment-emergent AEs was 8.8% for CABOMETYX versus 0% for placebo. Rates of grade 3/4 treatment-emergent AEs were 62% for CABOMETYX versus 28% for placebo, with no treatment-related deaths. Dose reductions due to AEs were required in 67% of patients treated with CABOMETYX versus 5% for placebo. Results from COSMIC-311 served as the basis for the September 17, 2021 U.S. Food and Drug Administration approval of CABOMETYX for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic DTC that has progressed following prior vascular endothelial growth factor receptor-targeted therapy and who are radioactive iodine-refractory or ineligible. The application was approved well ahead of the Prescription Drug User Fee Act target action date of December 4, 2021.

11:32 EDT Syros Pharmaceuticals presents new data from Phase 1 trial of SY-5609 - Syros Pharmaceuticals announced new data from the dose-escalation portion of the Phase 1 clinical trial of SY-5609, its highly selective and potent oral cyclin-dependent kinase 7 inhibitor, demonstrating clinical activity at tolerable doses as a single agent across multiple tumor types. The data is being presented in an oral presentation at the 2021 ESMO Congress. The Phase 1 multi-center, open-label dose-escalation study of SY-5609 enrolled patients with advanced breast, colorectal, lung, ovarian and pancreatic cancers, as well as patients with solid tumors of any histology harboring Rb pathway alterations. Patients were treated in cohorts exploring continuous daily dosing as well as intermittent dosing regimens, including seven days on treatment and seven days off and five days on treatment and two days off. As of July 6, 54 patients treated with single-agent SY-5609 in the study were eligible for a safety analysis and 45 patients were evaluable for clinical response. The median age of patients enrolled in the study was 65.5. Patients had been heavily pre-treated with as many as eight prior therapies and a median of four prior therapies. Across all doses and schedules, the majority of adverse events were low-grade and reversible. The most common treatment-emergent AEs were nausea, diarrhea, thrombocytopenia, fatigue and anemia. Low rate of discontinuations due to AEs. Tolerability was optimized with 7d on/7d off schedule, which had lowest rates of treatment-emergent AEs, while demonstrating comparable rates of stable disease as seen with more dose-intense regimens, supporting the selection of this schedule for further development of SY-5609. The maximum tolerated dose of the 7d on/7d off schedule has not yet been reached. Changes in POLR2A mRNA expression, a pharmacodynamic marker for CDK7 inhibition, were associated with anti-tumor activity and were sustained for at least three days following drug cessation, supporting intermittent dosing. Thirteen patients achieved SD, with tumor regressions of up to 20% in six of those patients, across multiple tumor types. The most substantial clinical activity was observed in heavily pre-treated patients with advanced pancreatic cancer. Five of 13 evaluable patients achieved SD, with tumor reductions in two of those patients. Reductions in the CA 19-9 tumor marker, which is used in clinical practice to monitor tumor progression, were observed in three of four pancreatic cancer patients with serial CA 19-9 data. These reductions ranged from 32% to 72%. Notably, one metastatic pancreatic cancer patient who had failed two prior lines of therapy and relapsed after a third line of treatment experienced prolonged SD of up to 10 months. Analysis of clinical activity by tumor type and mutational status supports the mechanistic rationale for SY-5609 in Rb-altered and KRAS-mutant cancers. Further development of SY-5609 will explore three combination regimens, focusing initially on indications with compelling clinical and/or preclinical activity, as well as a strong mechanistic rationale and high unmet need. Syros plans to initiate an expansion cohort evaluating SY-5609 in combination with chemotherapy for the treatment of pancreatic cancer in the fourth quarter of 2021. Syros also plans to initiate a Phase 1b trial evaluating SY-5609 in combination with a Bruton's tyrosine kinase inhibitor for the treatment of mantle cell lymphoma in the first half of 2022. Syros plans to employ a 7d on/7d off dosing schedule in both of these trials. In addition, as announced in August 2021, Syros entered into an agreement with Roche to explore SY-5609 in combination with atezolizumab in patients with BRAF-mutant colorectal cancer in Roche's ongoing Phase 1/1b INTRINSIC trial. Syros also presented new preclinical data at ESMO evaluating the anti-tumor and PD activity of intermittent dosing regimens for SY-5609, as well as new preclinical data evaluating SY-5609 as a single agent and in combination with chemotherapy in pancreatic cancer models. Taken together, these data further support Syros' dose expansion strategy, including the decision to use a 7d on/7d off dosing schedule and combine with chemotherapy in patients with pancreatic cancer. The data showed that SY-5609: Induced robust anti-tumor activity as a single agent in ovarian cancer models that was maintained at higher doses on intermittent schedules, including a 7d on/7d off schedule. POLR2A PD effects were sustained in tumor tissue through 72 hours post-dosing, consistent with what was observed in patients in the dose-escalation study. Induced regressions as a single agent in half of the pancreatic cancer models that were studied, including models derived from heavily pre-treated patients. Resulted in deeper responses when combined on 7d on/7d off schedule with gemcitabine in KRAS-mutant pancreatic models than either agent alone.

11:06 EDT PureTech Health announces publication on mesenteric lymphatic dysfunction - PureTech Health announced the publication of a research paper in Nature Metabolism, which showed for the first time that restoring normal function of the mesenteric lymphatics may reverse insulin resistance and modify obesity-associated metabolic disease. Results from the preclinical study provide further support for the therapeutic potential of PureTech's Glyph technology platform, which is designed to enable the trafficking of small molecule drugs directly into the mesenteric lymphatic system following oral administration. The groundbreaking study was led by PureTech collaborators Natalie Trevaskis, Ph.D., Associate Professor at the Monash Institute of Pharmaceutical Sciences in Australia, Christopher Porter, Ph.D., MIPS Director, and Enyuan Cao, Ph.D., Post-Doctoral Research Fellow at MIPS, in collaboration with PureTech scientists. The work demonstrates that obesity may be associated with profound and progressive dysfunction of the mesenteric lymphatic system. As shown in preclinical models, a high-fat diet stimulated the formation of new lymphatic vessels, which grew in a highly disorganized pattern. These tortuous, branching vessels tended to leak lymphatic fluid rich in lipid metabolites and pro-inflammatory mediators into the visceral adipose tissue in the abdomen, triggering the promotion of insulin resistance. Results from ex vivo experiments using clinical samples suggest that these observations may extend to humans as well. The study also found that inhibition of COX-2 and VEGF-C signaling within the mesenteric lymphatics resulted in a repatterning of the lymphatic vasculature, which in turn led to reduced branching and significantly less leakage of lymphatic fluids rich in lipids and pro-inflammatory mediators. Additionally, targeted inhibition of COX-2 function with a celecoxib prodrug developed using PureTech's lymphatic targeting Glyph technology platform led to a normalization of multiple biomarkers, including VEGF-C concentrations specifically within mesenteric lymph and surrounding adipose tissue, and to levels observed in control animals that were not fed a high-fat diet. This correlated with reduced lymphatic vessel branching and leakage as well as restoration of glycemic control, and weight gain was blocked in the animals fed a high-fat diet. In fact, targeted administration of the celecoxib Glyph prodrug led to a 10-fold greater uptake of celecoxib in mesenteric lymph and more effective restoration of lymphatic function and glycemic control compared to the administration of unmodified celecoxib, which is commercially available.

11:02 EDT Group of CytoDyn stockholders announces federal court dismissal of litigation - A group of long-time stockholders of CytoDyn that has nominated director candidates to serve on the Company's Board of Directors announced that Judge Maryellen Noreika has approved a joint stipulation to dismiss CYDY's lawsuit in the United States District Court for the District of Delaware. The litigation, which related to disclosures by the Nominating Stockholders, was an attempt by CYDY to prevent stockholders from having the opportunity to vote for the Nominating Stockholders' director candidates. The Nominating Stockholders said, "While we believe that we would have prevailed in this litigation, as the disclosures were not necessary, we are pleased to provide CYDY stockholders with additional information and resolve this matter. By ending this meritless litigation, we stop the waste of valuable corporate resources at a time when CYDY's finances are dwindling due to years of poor performance as a result of inept management. Stockholders can now focus their attention on the future of their company by voting for directors who will act in their best interest by earning FDA approval for Leronlimab, which will improve thousands of lives and generate significant long-term value." To ensure that voting rights of all CYDY stockholders can be expressed, the litigation brought by the Nominating Stockholders in the Delaware Court of Chancery remains pending. That litigation seeks to enforce the rights of CYDY stockholders and to allow them to vote for the Group's nominees after the current CYDY Board issued several communications falsely stating that stockholders cannot do so. Rhe Nominating Stockholders and their slate of director nominees for the CYDY Board remain fully committed to the proxy contest and the election of the highly qualified nominees. In the coming weeks, the Nominating Stockholders and their team will continue to aggressively make the case for the election of their director nominees and for the positive impact they will have on CYDY's future.

10:21 EDT CytoDyn announces resolution of litigation with Rosenbaum/Patterson Group - The Board of Directors of CytoDyn announced the resolution of its lawsuit brought in the United States District Court for the District of Delaware against the activist group led by Paul Rosenbaum and Bruce Patterson. In connection with the Federal Lawsuit, the Activist Group issued more than 30 pages of corrective and new disclosures, including the corrective disclosures previously made in connection with the Court's Stipulated Order. The new disclosures demonstrate that the Activist Group was not forthcoming with shareholders about its conflicts of interest, sources of funding and agenda at the outset. The Company believes there remain numerous open questions about the Activist Group's disclosures, but the Company has decided it is not worth further litigation on those issues now that it has become fully apparent that the Activist Group has been untruthful. Specifically with respect to the resolution of the Federal Lawsuit, the Activist Group took the following steps, which were conveyed in its public filings made after the close of the market on Friday, September 17, 2021: The Activist Group dissolved its Schedule 13D group and filed an "exit" Schedule 13D. This means that the formal Activist Group has been reduced from 28 members to 7 individuals, now including only Messrs. Rosenbaum and Patterson, their other three purported nominees and two other individuals. The Activist Group's total CytoDyn share ownership has now been reduced from 7.67% to 0.96%. The Activist Group has now made significant new disclosures about their financing sources. The Activist Group had to make corrective disclosures regarding its conflicts of interest, none of which had been disclosed in its initial proxy materials. In their new proxy disclosures, the Activist Group admitted that votes and proxies for their nominees are at risk. To reiterate, CytoDyn urges shareholders to ignore any further emails or mailings from the Activist Group. Shareholders do not need to take any action at this time. Shareholders will be receiving the Company's definitive proxy materials once they have been reviewed by the SEC. To the extent shareholders have voted on the Group's proxy card, they can vote on the Company's proxy card once it becomes available to revoke their vote on the Activist Group's card. Only the latest-dated proxy card counts.

10:15 EDT Coinbase officially launches Prime to all institutions - Coinbase said in a blog post: "We have been working tirelessly since our beta launch in May to ensure that Coinbase Prime is the most comprehensive platform for institutional investors. Today, we're officially launching Coinbase Prime to all institutions. Coinbase Prime combines advanced trading, battle-tested custody, and financing in a single solution. Along the way, we've continued to add more venues to our smart router which allows clients to achieve the best available price, more assets to our custody capability, enhanced our post-trade reporting capabilities, and added to our post trade credit financing options." Reference Link

10:02 EDT Edesa Biotech announces Phase 2 data of EB05 treatment of CVOID-19 patients - Edesa Biotech announced "positive" results from the Phase 2 part of an ongoing Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate, designated EB05, as a single-dose treatment for hospitalized COVID-19 patients. An independent Data and Safety Monitoring Board, or DSMB informed the company that during its initial analysis of the Phase 2 portion of the study they identified an important signal between the treatment arms for 28-day mortality, and requested that the study be preemptively unblinded. While the Phase 2 portion was primarily designed to refine patient stratification and statistical powering for the Phase 3 study, the DSMB concluded that "a clinically important efficacy signal" was detected and that the study has "met its objective." The DSMB further recommended continuation of the study into a Phase 3 confirmatory trial. Among the findings, the DSMB reported a 28-day death rate of 14.3% in the EB05 arm versus 36.8% in the placebo arm in critically severe patients on ECMO therapy. Survival Analysis using Cox's Proportional Hazard Model showed that the patients treated with EB05 plus standard of care had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days. The currently available data indicates that greater than 90% of patients received dexamethasone, more than 45% received both tocilizumab and a steroid. The results from the Phase 2 analysis also suggest that EB05 has been generally well-tolerated and consistent with the observed safety profile to date. In addition, the DSMB identified another patient group with robust signals for mortality reduction at 28 days and the company plans to review this data as well as the full dataset. The analysis reviewed data from approximately 360 patients, 24 to 93 years of age, from investigational sites in the United States, Canada and Colombia. Based on the Phase 2 results and guidance from the DSMB, Edesa plans to focus on patient segments that have demonstrated the strongest efficacy signals and have the greatest potential of rapidly completing enrollment, beginning with critically severe patients. The company intends to file amendments with regulators in the United States, Canada and Colombia to update the Phase 3 protocol and set targeted enrollment. Edesa is also evaluating opportunities to apply for expedited regulatory review programs in the U.S. and Canada.

10:00 EDT iHuman falls -10.4% - iHuman is down -10.4%, or -58c to $5.02.

10:00 EDT Direxion Daily Semiconductor Bear 3X Shares rises 5.9% - Direxion Daily Semiconductor Bear 3X Shares is up 5.9%, or 37c to $6.61.

10:00 EDT Vicarious Surgical rises 11.6% - Vicarious Surgical is up 11.6%, or $1.34 to $12.91.

09:47 EDT IronNet falls -13.5% - IronNet is down -13.5%, or -$4.08 to $26.18.

09:47 EDT Direxion Daily Semiconductor Bear 3X Shares rises 6.6% - Direxion Daily Semiconductor Bear 3X Shares is up 6.6%, or 41c to $6.65.

09:47 EDT Vicarious Surgical rises 12.4% - Vicarious Surgical is up 12.4%, or $1.43 to $13.00.

09:32 EDT BowX Acquisition files proxy statement, to vote Oct. 19 on WeWork deal - BowX Acquisition Corp. has filed its definitive proxy statement/prospectus with the SEC and established September 14, 2021 as the record date in connection with the previously announced proposed business combination with WeWork. A special meeting of BowX's stockholders to approve the business combination will be held virtually on October 19, 2021 at 11:00 AM, Eastern Time. The business combination is expected to close on or about October 21, 2021, subject to BowX stockholder approval and the satisfaction of certain closing conditions. Following the completion of the business combination, WeWork expects to be listed on the New York Stock Exchange under the symbol "WE."

09:29 EDT Brunswick's Advanced Systems Group acquires SemahTronix - Brunswick Corporation announced that it has acquired SemahTronix, a global supplier of high-complexity electrical wiring harnesses for advanced products in the marine, mobile, and defense industries. The company will become part of Brunswick's Advanced Systems Group (ASG) which consists of leading P&A brands in advanced batteries, electrical power management, digital control & monitoring, and networked systems & devices for the marine, RV, specialty vehicle, and other industries. Financial terms of the deal were not disclosed. Headquartered in Flippin, Arkansas, SemahTronix has more than 40 years of experience specializing in all aspects of harnessing solutions from application and design engineering through custom components. This marks the third announced acquisition for Brunswick's Advanced System Group in the past four months, including the June announcement that the Company had entered into a definitive agreement to acquire Navico and the September acquisition of the RELiON Battery, LLC business.

09:28 EDT Merit Medical announces results in first-in-human study of WRAPSODY - Merit Medical Systems announced results from a prospective, observational, first-in-human study to evaluate the safety and effectiveness of the Merit WRAPSODY Endoprosthesis. The WRAPSODY Endoprosthesis is a self-expanding, cell-impermeable endoprosthesis designed for the treatment of arteriovenous fistula access circuit stenosis and AV graft access circuit stenosis. The WRAPSODY FIRST Study enrolled 46 subjects with clinically relevant stenosis, who were treated at three centers. The eligible population consisted of patients undergoing hemodialysis through an AV circuit with clinical and radiological evidence of stenosis at the graft-vein anastomosis, in the peripheral outflow veins or in the central veins up to the superior vena cava. The subjects did not have clinically relevant secondary stenosis or thrombus in the access circuit. The study reported anatomical, clinical and procedural success in all cases. The primary safety outcome measure was the proportion of subjects without localized or systemic safety events affecting the access circuit that resulted in surgery, hospitalization or death during the first 30 days following device placement. All but one subject was free from such a safety event in the first 30 days following device placement. The safety event was adjudicated as not related to the device or study procedure. Over the remainder of the study, there was one adverse event adjudicated as possibly device-related. The primary effectiveness outcome measure for the study was the TLPP rate at 30 days following device placement, which was 100%. At 6 months following device placement, the TLPP rate was 97.7% and at 12 months following device placement, it was 84.6%. The 6- and 12-month ACPP rates were 84.4% and 65.9%, respectively. TLPP rates were similar regardless of access type and lesion location or whether subjects were treated with a single device or overlapping devices. In all cases, reintervention at the target lesion was successful in maintaining patency. Merit is also conducting a large multinational, multicenter study, identified as the WAVE Study, which it plans to use to support a premarket approval application to the United States Food & Drug Administration. Enrollment in the randomized WAVE Study comparing the Merit WRAPSODY Endoprosthesis to percutaneous transluminal angioplasty for treatment of venous outflow circuit stenosis or occlusion in hemodialysis patients began in March 2021. Merit anticipates that the WAVE Study will include 477 subjects.

09:27 EDT Pilgrim's Pride forms special committee to evaluate JBS unsolicited proposal - The board of directors of Pilgrim's Pride Corporation has formed a special committee of independent directors to review and evaluate the previously announced unsolicited proposal received on August 12, 2021 from JBS S.A. to acquire all of the outstanding shares of common stock of PPC that JBS does not currently own. The special committee has retained Skadden, Arps, Slate, Meagher & Flom LLP as legal counsel, and Goldman Sachs & Co. LLC, as financial advisor to assist the special committee in its review and evaluation of the JBS proposal. The board resolutions establishing the special committee expressly provide that the PPC board of directors will not approve the transaction proposed by JBS without the prior favorable recommendation of the special committee, and that any such transaction will be conditioned on the affirmative vote of a majority of PPC shares that are not held by JBS or its affiliates. There can be no assurance that a definitive agreement relating to the JBS proposal will be entered into by PPC, or that any transaction will be consummated.

09:24 EDT AbbVie submits regulatory application to FDA fror risankizumab-rzaa - AbbVie announced that it has submitted an application to the U.S. Food and Drug Administration seeking approval for risankizumab-rzaa induction and 360 mg subcutaneous, an interleukin-23 inhibitor, for the treatment of patients 16 years and older with moderate to severe Crohn's disease. The submission is supported by safety and efficacy data from three Phase 3 studies - ADVANCE, MOTIVATE and FORTIFY. In the analysis plans for the U.S. submission of the ADVANCE and MOTIVATE induction studies, a significantly greater proportion of patients with Crohn's disease treated with either dose of risankizumab-rzaa IV induction therapy met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo. In the analysis plans for the U.S. submission of the FORTIFY trial, a randomized-withdrawal maintenance trial of patients with clinical response to risankizumab-rzaa induction therapy, a significantly greater proportion of participants achieved the co-primary endpoints of endoscopic response and clinical remission with risankizumab-rzaa SC maintenance therapy at one year for both assessed doses, compared to those who were randomized to the withdrawal arm and received placebo SC. The safety profile of all tested doses of risankizumab-rzaa in moderate to severe Crohn's disease in the ADVANCE, MOTIVATE and FORTIFY studies was generally consistent with the known safety profile of risankizumab-rzaa.

09:22 EDT Roche says new Phase 3 data support Tecentriq benefit in early-stage lung cancer - Roche announced that it presented new data from the Phase 3 IMpower010 study at the European Society for Medical Oncology, or ESMO, Congress 2021 Presidential Symposium, reinforcing the significant disease-free survival benefit offered by Tecentriq for people with Stage II-IIIA non-small cell lung cancer, or NSCLC, whose tumors express PD-L1 greater than or equal to 1%. Data from the IMpower010 trial were published simultaneously in The Lancet. In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the risk of disease recurrence or death by 34% in people with Stage II-IIIA NSCLC whose tumors express PD-L1 greater than or equal to 1%, compared with best supportive care. Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified, the company stated.

09:17 EDT AIM ImmunoTech provides update on pending Phase 2a trial of Ampligen - AIM ImmunoTech provided a status update on its Phase 2a Human Challenge Trial to test the company's drug Ampligen as a potential intranasal prophylactic therapy using a human rhinovirus and influenza A virus. The proposed protocol for the AIM-sponsored study was submitted to the Oxford Research Ethics Committee/Medicines and Healthcare Regulatory Agency on September 10, 2021. A meeting is scheduled to review the study on September 24, and the response is expected by mid November. In addition, AIM and hVIVO continue to work to finalize the details of a Clinical Trial Agreement and hope to announce its signing soon. hVIVO is a subsidiary of Open Orphan plc, a rapidly growing specialist contract research organization and world leader in vaccine and antiviral testing using human challenge clinical trials. The study should move forward quickly following the expected approval of the REC/MHRA and a final agreement with hVIVO. The Phase 2a HCT is a single center, prospective, randomized, double-blind, placebo-controlled study of Ampligen administered intranasally to healthy adult male and female participants. In an HCT, subjects are intentionally exposed to particular diseases to test how the diseases will respond to potential therapeutics. An HCT will allow AIM to expedite the development process for Ampligen by ensuring full exposure of both the control group and the Ampligen group, so as to assess whether there is a prophylactic effect. A total of 64 participants are planned to participate in this study; 32 participants will be randomized and inoculated with influenza A/Perth/16/2009 and 32 participants will be randomized and inoculated with HRV-16 for an estimated total of 64 evaluable participants. In each group, 16 participants will be receiving Ampligen and 16 participants will be receiving placebo. A successful Phase 2a study could also help establish Ampligen as a potential prophylaxis against future viral variants and future novel respiratory viruses for which there are no current therapies, as well as known viruses such as SARS-CoV-2, which causes COVID-19.

09:15 EDT eHealth appoints Christine Janofsky as Chief Financial Officer - eHealth announced that Christine Janofsky has joined its leadership team on September 20th as senior vice president, SVP, chief financial officer. In her new role, she will oversee all aspects of finance including financial strategy, planning and analysis, accounting, tax and treasury. John Pierantoni, who served as the company's interim principal financial officer, will remain its chief accounting officer. Janofsky brings more than 20 years of finance and insurance experience to eHealth, most recently serving as senior vice president and chief accounting officer at Lincoln Financial Group since 2016.

09:13 EDT uCloudlink strengthens presence in South-East Asia with new partnership - UCLOUDLINK GROUP is continuing to expand its footprint in South-East Asia such as strengthening business partnerships in Vietnam. uCloudlink has recently extended a partnership agreement with a local telecommunications service company in Vietnam, which will see the partner distribute uCloudlink's mobile broadband products and services to its customer base. uCloudlink has been working with this partner since January 2020 to bring data connectivity services to users across the country. Together with expanding PaaS and SaaS ecosystem, uCloudlink will enable fast, secure and reliable data connection services to more users and business partners globally. uCloudlink is actively seeking to expand and strengthen its partner ecosystem in South-East Asia to ensure more users have access to stable and reliable data connectivity at all times. By leveraging its patented CloudSIM technology and HyperConn solution through its PaaS and SaaS platform, uCloudlink's mobile broadband products and services enable users to overcome limitations and allow users to access all available networks through a single operator entry point. In addition to its partnerships in Vietnam, the company has inked several cooperation agreements in various markets across the region, including new business partners in Malaysia, Philippines, Indonesia, and more.

09:11 EDT Mr. Cooper to sell Xome Field Services unit, terms undisclosed - Mr. Cooper announced that it has entered into a definitive agreement to sell its Xome Field Services unit to Cyprexx Services. The sale is expected to close during Q4, subject to customary conditions. The terms of the transaction have not been disclosed, however, the company does not view the financial impact as significant.

09:07 EDT Accenture to acquire Brazil-based Experity, terms undisclosed - Accenture announced its intent to acquire Experity, a provider of cloud-based customer experience and commerce solutions in Brazil. Experity helps businesses build greater efficiencies and agility in commerce, marketing, content and data through leading cloud-based technologies. Accelerated by the pandemic, Brazil's e-commerce spending has reached historic levels - nearly $10B in the first six months of the year - pushing brands to rapidly reimagine their commerce experience. Marrying Experity's expertise with Accenture Interactive's global scale and capabilities will enhance the company's ability to deliver seamless commerce experiences. Cristiano Dencker, Accenture Interactive Lead for Latin America, said: "Experity will solidify and scale our market capabilities in driving experience-led transformation. The company will bring strong leadership and expertise with key ecosystem partners, which helps us continue to deliver exemplary services in commerce, marketing, content and data for clients in Latin America." Terms of the transaction are not being disclosed. Completion of the acquisition is subject to customary closing conditions.

09:07 EDT Mondelez announces new contracts for U.S. BCTGM-represented employees - Mondelez International announced the ratification of new contracts for BCTGM-represented employees at its Chicago, IL , Portland, OR, and Richmond, VA biscuit bakeries, as well as its Aurora, CO, Addison, IL and Norcross, GA sales distribution facilities. The new contracts will help sustain the Company's long-term growth and need for increased flexibility within the business to meet elevated demand. The agreement also increases wages and ensures competitive benefits for employees. The four-year contracts, which are retroactive to March 1, 2021, include a ratification bonus for each employee, hourly wage increases each year of the contract, increased company match to 401(k) contributions, and new flexible work schedules to unlock additional capacity. These terms represent a significant step forward for both the Company and its employees. As the Company looks ahead and anticipates additional volume growth, it also will be well positioned to increase capacity through potential new investments in these plants.

09:05 EDT Argonne National Lab, Gevo partner to apply GREET Model to net-zero project - The U.S. Department of Energy's Argonne National Laboratory recently partnered with Gevo to perform a critical lifecycle analysis of its next-generation technology. Using data provided by Gevo, Argonne's Greenhouse gases, Regulated Emissions, and Energy use in Technologies Model is expected to yield results regarding carbon footprints of these fuels within a few months. The effort is funded by the DOE's Bioenergy Technologies Office, which is part of the Office of Energy Efficiency and Renewable Energy.

09:04 EDT Xerox promotes Deena LaMarque Piquion as CMO - Xerox Holdings announced the promotion of Deena LaMarque Piquion as Chief Marketing Officer. Previously serving as Senior Vice President and General Manager of Xerox's Latin America Operations, Piquion brings 20 years of experience leading sales, marketing and operations teams for industry-leading information technology companies. As CMO, Piquion will lead Xerox's marketing functions. She will be responsible for enabling go-to-market teams to generate revenue and for building awareness and demand for Xerox's offerings and new businesses. Piquion will serve as a member of the company's Executive Committee and report to Vice Chairman and CEO, John Visentin.

09:03 EDT Virpax Pharmaceuticals acquires rights to Nanomerics MET for CBD delivery - Virpax Pharmaceuticals has acquired the exclusive worldwide rights from Nanomerics to use Nanomeric's molecular envelope platform technology, or MET, for the nasal delivery of a cannabidiol, or CBD, for the management of epilepsy in adults and children. Under the license agreement with Nanomerics, Virpax has the right to develop, manufacture, market and sell VRP324, the first investigational formulation delivered via the nasal route to enhance CBD transport to the brain. VRP324 uses a preassembled device and cartridge to propel the CBD powder formulation into the nose to the brain via the olfactory nerve/bulb. This product candidate will be formulated to potentially treat seizures associated with tuberous sclerosis complex, or TSC, Lennox-Gastaut syndrome and Dravet syndrome in patients one year of age and older. Lennox-Gastaut syndrome and Dravet syndrome are rare central nervous system diseases considered serious epileptic encephalopathies that cause different types of epileptic seizures as well as cognitive and behavioral changes and are generally resistant to treatment. Nanomerics has initiated preclinical studies of VRP324. If animal studies are successfully completed, Virpax plans to immediately proceed with preparing a pre-Investigational new drug application briefing document for the FDA's review.

09:02 EDT Abbott receives FDA approval for Portico with FlexNav TAVR system - Abbott announced that the U.S. Food and Drug Administration has approved the company's Portico with FlexNav transcatheter aortic valve replacement system to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery. With this latest TAVR advancement, Abbott continues to offer the industry's leading portfolio of structural heart solutions that include innovative, minimally invasive therapies to repair or replace diseased or damaged heart valves or close openings in the heart. With years of experience globally, Portico is a self-expanding TAVR valve with intra-annular leaflets that help provide optimal blood flow when placed inside a patient's natural valve. The structure of the replacement valve also preserves access to the critical coronary arteries for future coronary interventions. The Portico device is implanted using Abbott's FlexNav delivery system, which features a slim design to accommodate different patient anatomies and small vessels, and optimizes flexibility, tracking and precision of valve placement.

08:58 EDT AAR Corp. awarded $41M contract by NNSA for transport aircraft - AAR was awarded a firm, fixed-price contract by the Department of Energy's National Nuclear Security Administration for the conversion and delivery of a B737-700 aircraft modified into a "FlexCombi" configuration. With this acquisition, the NNSA will increase its fleet size to support mission-critical activities to maintain the safety, security and effectiveness of the United States' nuclear deterrent capacity. The FlexCombi configuration gives the NNSA the ability to quickly configure the aircraft between passenger and/or cargo modes, serving ever-evolving mission requirements. Work will commence immediately and be completed within twelve months.

08:56 EDT Sify Technologies says Data Center at Vashi completes 21 years in operation - Sify Technologies announced that its Data Center at Vashi, the first commercial Data Center in India, completed 21 years of uninterrupted operations. Sify Technologies expanded into the Data Center business in the year 2000. Sify has built and today operates 10 carrier-neutral Data Centers, currently offering more than 70 MW IT Power. Following the facility at Vashi, Sify followed up with larger capacities in Bangalore, Chennai, Airoli, Noida, Rabale, Hyderabad and Kolkata and aims to add 200 MW in the next 4 years. Through CloudCover, Sify also services a network of 49 Data Centers across India.

08:54 EDT PDS Biotechnology achieves safety requirement milestone in VERSATILE-002 trial - PDS Biotechnology announced its VERSATILE-002 Phase 2 study for the treatment of advanced human papillomavirus-associated head and neck cancer achieved its preliminary safety benchmark in its first 12 patients. Enrollment in the trial, which studies PDS0101 administered in combination with KEYTRUDA, will now continue to full enrollment of the first stage of the study, which will assess efficacy in 17 checkpoint inhibitor naive patients and in an additional group of 21 patients who have also failed prior therapy with checkpoint inhibitors. The trial is being conducted in collaboration with Merck & Co. VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor. The second group of patients have failed multiple treatments including CPI therapy. As specified in the clinical trial design, the achievement of an objective response as measured by radiographic tumor responses according to RECIST 1.1 among at least four of the first 17 patients in the CPI naive arm and at least 2 patients in the first 21 patients of the CPI refractory arm will trigger advancement to the second stage of the study and full enrollment of the planned 95 patients. The advancement of the VERSATILE-002 trial follows the previously disclosed presentation at the American Society of Clinical Oncology 2021 Annual Meeting of interim data in a separate Phase 2 trial being led by the National Cancer Institute. That trial is evaluating the combination of PDS0101 with two investigational immunotherapies in patients with advanced HPV-related cancers. That trial has enrolled patients with anal, cervical, head and neck, vaginal and vulvar cancer, who have failed prior treatment. Objective responses measured according to RECIST 1.1 were reported in 83% of HPV16-positive patients who had failed chemotherapy and radiation but were CPI naive. In CPI refractory patients, tumor reduction was reported in 58% and objective responses in 42%. Two patients, one in each group were reported to have a complete response at the time of reporting. Clinical responses were observed in all HPV16-positive tumor types enrolled.

08:50 EDT Safe-T launches new enterprise data collection solution - Safe-T Group announced the launch of a new enterprise data collection solution, enabling unlimited collection of online, public, web-based data. The new product will be an addition to Safe-T's enterprise privacy business unit solutions portfolio which continues to focus on expanding its presence in the large and growing data collection market. Delivered as a Data Collection-as-a-Service and powered by Safe-T's unique hybrid enterprise privacy network which is utilized by hundreds of business customers around the world, the web data collector solution will allow enterprises to gather information at any scale from any public-facing website. Using a simple, yet powerful API interface that allows for easy integration into any major data analytics platform, enterprise customers will be able to gather needed web data at a 100% success rate without the need for complex web crawlers or utilizing a proxy network. Safe-T's new data collector will address key needs for data-driven decision making based upon publicly available web information across numerous use-cases including e-commerce, price comparison, brand protection, SEO and market research. This will allow enterprises to achieve competitive advantages in their industry without having to invest significantly in their infrastructure, saving time and reducing workload.

08:48 EDT J.Jill CEO buys 5K shares of common stock - In a regulatory filing, J.Jill disclosed that its CEO Claire Spofford bought 5K shares of common stock on September 17th in a total transaction size of $81.4K.

08:46 EDT Johnson Controls, Atos to partner to accelerate journey to net zero buildings - Atos and Johnson Controls announced a global partnership. Atos and Johnson Controls will help private and public sector customers accelerate their journey to Net Zero by providing a set of end-to-end advisory services, digital and other decarbonization capabilities which aims to help clients formulate and sustainably achieve their Net Zero strategy by reducing their commercial, industrial and office building carbon emissions. Atos and Johnson Controls plan to leverage each company's leading capabilities to help customers better assess, plan, manage, report and forecast carbon performance of buildings. Atos' Net Zero Transformation portfolio features Atos EcoAct advisory solutions, such as Digital Decarbonization Assessments and Sustainability Strategy development. These services are activated by Johnson Controls Open Blue Net Zero Buildings portfolio which enables customers to achieve their sustainability strategy and goals that can drive 50 percent and more in improvement in energy efficiency and corresponding carbon emissions. Additionally, the companies plan to work together to deliver new digital capabilities by bringing together the benefits of Atos' Digital Decarbonization Exchange built on the Atos Digital Hub foundation with Johnson Controls' OpenBlue Platform and Net Zero Advisor solution, which will help customers by providing real-time AI enabled monitoring and reporting of sustainability metrics as well as clean energy. The joint collaboration on data and services will enable clients to gain a detailed initial understanding of their real estate energy usage, and to build a strategy and implementation programme of solutions to target energy reduction in line with their Net Zero ambitions. "Our customers have a clear and compelling imperative to reduce carbon emissions as part of the global drive to combat climate change, with many striving for decarbonization by 2030," said George Oliver, Johnson Controls chairman and CEO. "Together, Atos and Johnson Controls bring a powerful set of complementary decarbonization solutions and open technology platforms to help our customers, businesses and others, drive down carbon emissions while creating environments for healthy people, healthy places, and a healthy planet," Oliver added.

08:44 EDT Horizon Bancorp completes acquisition of 14 Michigan branches - Horizon Bank announced the completion of its previously announced acquisition of 14 branches in 11 Michigan counties. The acquisition of the 14 branches and associated deposits and loans from TCF National Bank, now The Huntington National Bank, adds mass and scale to Horizon's Midland market and extends its footprint into attractive markets in the northern and central regions of Michigan's Lower Peninsula. Conversion of the branches began Friday evening, September 17, 2021, and continued through the weekend, with all 14 locations reopening this morning, Monday, September 20, 2021, as Horizon Bank branches. This latest branch transaction is Horizon Bank's 15th acquisition since 2002 and fifth in the last five years. Horizon Bank now operates 88 bank branches, including 29 in Michigan, and customers across its diverse and economically attractive Midwestern markets conduct a majority of their transactions through its convenient digital and virtual banking channels.

08:42 EDT Aadi Bioscience appoints Brendan Delaney as COO - Aadi Bioscience announced the appointment of Brendan Delaney to the role of COO. Most recently Brendan was CCO at Constellation Pharmaceuticals.

08:40 EDT INNOVATE Corp. completes name change from HC2 Holdings - INNOVATE Corp. announced its successful name change from HC2 Holdings, Inc., which became effective today. The Company's common stock will continue to be publicly traded on the New York Stock Exchange, with trading to begin under its new ticker symbol, "VATE", at market open on September 20, 2021. The completion of the name change reflects the Company's focus on innovative growth businesses, including its best-in-class Infrastructure, Life Sciences and Spectrum segments. In connection with the rebranding, the Company has relocated its corporate website to www.INNOVATECorp.com where investors and other stakeholders may find additional information. As previously announced, INNOVATE's common stock will bear a new CUSIP number and a new ISIN. No action is required by stockholders with respect to the name change.

08:39 EDT Allogene Therapeutics appoints Jae Park to Scientific Advisory Board - Allogene Therapeutics announced the appointment of Jae Park, M.D., acting Chief of Cellular Therapeutics at Memorial Sloan Kettering Cancer Center in New York, to its Scientific Advisory Board. Dr. Park, widely recognized as one of the world experts in cell therapies, is the leading principal investigator of several clinical trials in patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia and acute lymphoblastic leukemia.

08:37 EDT PTC Therapeutics presented results from STRIDE study - PTC Therapeutics presented results from the STRIDE patient registry demonstrating that treatment with Translarna delays loss of ambulation by more than five years in boys with nonsense mutation Duchenne muscular dystrophy, or nmDMD, compared to standard of care, or SoC, alone. Pulmonary function decline was also delayed by 1.8 years in those treated with Translarna and SoC. "The five-year analysis of the STRIDE registry clearly demonstrates Translarna's profound impact on changing the course of disease progression, said Stuart W. Peltz, Ph.D., Chief Executive Officer of PTC Therapeutics. "We are all proud to see Translana's life-changing effect on boys with Duchenne. The results robustness showing both a five-year delay in loss of walking as well as its ability to prolong lung function confirms what we have seen in our clinical trials. These results add to the totality of the evidence of Translarna's benefit for the patients and their families." The median age that boys treated with Translarna reached a predicted forced vital capacity lower than 60% was 17.6 years old, compared with 15.8 years old for those who did not receive Translarna. This delay in loss of lung function is critical, as the sub-60% threshold is considered the milestone at which patients usually start to require respiratory physical therapy. The analysis is based on results from 241 boys in 13 countries who were enrolled in the STRIDE patient registry over the past five years. Translarna continues to be well tolerated in nmDMD patients, and the safety results, representing 1059 patient-years of exposure, remain consistent with the therapy's known safety profile.

08:36 EDT Victory Square portfolio company Fantasy 360 signs LOI to acquire Synthesis VR - Victory Square Technologies is pleased to announce that its portfolio company, Fantasy 360 Technologies Inc. d/b/a Immersive Tech as signed a binding letter of intent dated September 17, 2021 in respect of the acquisition of all of the shares of Synthesis VR, A leading Location-based Virtual Reality content store & technology engine empowering nearly 300 out-of-home entertainment locations worldwide. Synthesis VR serves more than the Location-based entertainment industry with its first to market and industry leading technology but also operates a broader sandbox platform serving the education and enterprise sectors as well. As one of the largest and most active location-based VR communities globally, Synthesis VR has seen a large uptick in client operator growth and player engagement across its network. So far in 2021 alone the Synthesis VR global community has already logged over 10,000,000 minutes of game play with over 600,000 booking reservations across its global network of 300+ operator centers and 130,000+ active users. This is a sharp rise in player engagement and bookings over 2019 & 2020 which continued to see strong growth even through a global pandemic. Their catalogue of games and other experiences also continues to grow, to over 325, as the VR entertainment industry as a whole has seen large spikes in audience and game developers creating more VR games to answer the consumer demand as a result of the global pandemic. The acquisition will see the Synthesis VR team continue in their roles and the development roadmap that Fantasy 360 had created prior to this acquisition will be accelerated with an additional investment into the Synthesis VR core platform. Many new features and capabilities will be added to the Synthesis platform, continuing to grow, and providing added revenue opportunities to the Company's growing family of customers. Subject to applicable laws and the policies of the Canadian Securities Exchange, in consideration of the Acquisition, Fantasy 360 will pay an aggregate purchase price of $4,800,000 as follows: (i) $500,000 in cash with $150,000 payable upon closing, $50,000 payable on January 1, 2022, and a further $300,000 payable upon the completion of certain milestones; and (ii) common shares of Fantasy 360 with an aggregate value of $4,300,000 at a deemed price per Fantasy 360 Share equal to the market price of the Fantasy 360 Shares minus permitted discounts per policies of the CSE with a minimum price per Fantasy 360 Share] of $0.35, which such shares shall be subject to contractual escrow with tranches release over a period of 20 months. In addition, subject to applicable laws and the policies of the CSE, Fantasy 360 may issue additional Fantasy 360 Shares with an aggregate value of up to $5,000,000 upon the achievement of certain mutually agreed upon performance milestones The Company also announces that it has retained GRIT Capital CORP, an arm's-length party to the Company to provide social media marketing services, content creation, and distribution. The Company agrees to pay the service provider USD$50,000 for six-month service.

08:35 EDT Cooper-Standard appoints Kulikowski as VP, global internal audit - Cooper Standard announced the appointment of Amy Kulikowski to vice president, or VP, global internal audit and compliance effective September 20, 2021. She replaces Becky McCabe who was recently appointed vice president, chief accounting officer, Cooper Standard. In her new role, Kulikowski will provide leadership, strategy and planning for Cooper Standard's global internal audit and compliance activities. Based at the Company's world headquarters in Northville, Kulikowski will report to Jonathan Banas, executive vice president and chief financial officer.

08:33 EDT Tempest Therapeutics doses first patient in randomized study of TPST-1120 - Tempest Therapeutics announced the first patient has been dosed in the global randomized Phase 1b/2 clinical study evaluating TPST-1120, Tempest's small molecule PPAR antagonist, in combination with the standard-of-care regimen of atezolizumab and bevacizumab in the first-line treatment of patients with advanced or metastatic hepatocellular carcinoma. The trial is being conducted under a clinical collaboration with F. Hoffman La-Roche. The Phase 1b/2 global randomized study will evaluate TPST-1120 in combination with the standard-of-care regimen of atezolizumab and bevacizumab in patients with advanced or metastatic HCC not previously treated with systemic therapy. At least 40 and up to 60 patients will receive the TPST-1120 combination at approximately 25 sites worldwide including the United States, Asia, and Europe, and will be compared to the standard-of-care atezolizumab and bevacizumab regimen with primary objectives of anti-tumor activity and safety. Under the terms of the collaboration agreement, Roche will manage the study operations for this global, multicenter trial. Tempest retains global development and commercialization rights to TPST-1120.

08:31 EDT CommAgility 5G NR hardware, software selected by Shared Spectrum - Wireless Telecom Group announced that Shared Spectrum Company has selected 5G New Radio hardware and software from CommAgility for a US Department of Defense project. CommAgility was selected because of its comprehensive software and hardware portfolio for 5G NR, which simplifies the development of 5G networks by providing integrated, flexible and customizable core software and Radio Access Network elements. Shared Spectrum is working on the National Spectrum Consortium project, part of the DoD's awards for 5G experimentation and testing. The goal of this project is to develop technologies for 5G-enabled dynamic spectrum sharing, which will provide more available spectrum for new system users, with minimal impact on legacy wireless systems.

08:29 EDT electroCore appoints Peter Cuneo as board chairman - electroCore announced that the Board of Directors has appointed Peter Cuneo as Chairman of the Board of Directors effective October 1, 2021. Mr. Cuneo was appointed to the Board of Directors in April 2020. He succeeds Mike Atieh, who served as Chairman since April 2020 and who will remain on the Board as an independent director and member of the audit committee.

08:28 EDT WillScot Mobile Mini acquires three storage service companies - WillScot Mobile Mini Holdings announced that it closed the acquisitions of American Mobile Leasing, Inc., Equipe Container Services, Inc. d/b/a Moveable Container Storage, and Saf-T-Box, LP. The transactions were funded with cash on hand and borrowings under the Company's revolving credit agreement. Combined, these acquisitions add about 11,000 storage units in the Company's existing U.S. markets.

08:25 EDT Selecta Biosciences appoints Kevin Tan as CFO - Selecta Biosciences announced the appointment of Kevin Tan as chief financial officer. Prior to joining Selecta, Mr. Tan served as treasurer at Sarepta Therapeutics where he was responsible for the liquidity and capital management of the company.

08:23 EDT Driven by Stem acquires Artifact Extracts, two additional dispensaries - Stem Holdings announced that it has acquired Artifact Extracts, a premier cannabis extraction company based in Oregon known for its concentrates, as well as two dispensaries. The national market for concentrates grew 40% last year as new and current cannabis consumers turn to this product category. Strategic Highlights: With the acquisition of Artifact, Driven By Stem will be well positioned to capture additional market share, expand its presence in the fast-growing concentrates segment, and maximize value for all its shareholders. Increases footprint of fully-owned dispensaries on the West Coast to six locations. Expand Oregon presence with a dispensary in Salem, to be re-named TJ's on Broadway, and a dispensary in Eugene, to be re-named TJ's on 7th, flanking its two existing dispensaries in the city. Cannabis sales in Salem/Marion County were $73.5 million in 2020 growing 32.4% as compared to the prior year. Immediately launch the Budee proprietary delivery platform in Salem, extending its consumer reach with expedited service, with service expansion to Eugene in October. Supply consistent, high-quality biomass for Artifact from its cultivation operations for Stem's TJ's Gardens and Yerba Buena brands in Oregon, with accretive margins. Integrate Artifact's premier line of concentrates including budder, badder, shatter, crumble, rosin, THC A crystals, and other popular forms into Stem's family of brands and product lines. Expands the Company's distribution footprint by cross-selling into dispensaries not yet supplied with the full portfolio of Stem's brands, as well as including Artifact's presence in all TJ's dispensaries. Strengthen Stem's experienced management team with the integration of Artifact's skilled R&D leadership. The transaction closed September 17th, 2021 with all OLCC approvals granted. In connection with such transaction, Stem issued 8,209,178 shares of common stock of Stem at a deemed aggregate value of $2,925,000 at a 24% premium to Stem's closing share price of common stock. Such share consideration will be held in escrow for a period of six months with a subsequent six month leak out.

08:20 EDT Synnex, Indeni partner to expand security infrastructure automation solutions - Indeni announced its partnership with SYNNEX Corporation. For more than a decade, leading enterprises have trusted Indeni to protect their network reliability and reduce downtime by automating firewall maintenance, high availability assurance, and health and compliance audits. Its security infrastructure automation platform supports leading network security vendors, including Check Point, Palo Alto Networks, Fortinet, F5, Symantec Blue, Cisco ASA, Radware and Juniper. In addition to using automation to identify issues such as misconfigurations, Indeni partners with global users of these devices to develop best practices for resolving them.

08:19 EDT Cerence powers conversational AI in Audi e-tron GT, Audi Q4 e-tron - Cerence Inc. (CRNC) announced its continued work with Audi (AUDVF) to power the in-car assistant platform for the new Audi e-tron GT and the much-anticipated Audi Q4 e-tron compact electric SUV, providing voice-powered access to key features and functions like navigation, media, air conditioning and heating, phone calling and text messaging, and more. Audi's ongoing partnership with Cerence for intuitive, natural interaction in the e-tron GT and Q4 e-tron is indicative of the rising importance of the in-car experience in the next generation of innovative electric vehicles.

08:18 EDT Celularity, Oncternal Therapeutics enter research collaboration - Celularity Inc. (CELU) and Oncternal Therapeutics (ONCT) announced they have entered into a research collaboration to evaluate placental derived-cellular therapies targeting receptor-tyrosine kinase-like Orphan Receptor 1. As part of the collaboration, Celularity will explore the use of Oncternal's ROR1-targeted monoclonal antibody, cirmtuzumab, in combination with Celularity's natural killer cells. ROR1 targeted chimeric antigen receptor gene modification will also be explored in Celularity's CYNK natural killer cell and CyCART T cell platforms in preclinical studies. ROR1 is highly expressed by multiple solid tumors and hematological malignancies and confers both an aggressive phenotype and survival advantage to the tumor cells. Cirmtuzumab binding to ROR1 on leukemia and lymphoma cells decreases tumor cell proliferation and survival by blocking Wnt5a-induced activation, while it does not bind to adult tissues. Celularity will evaluate the use of cirmtuzumab in combination with CYNK-101, a placental derived-allogeneic NK cell therapy that has been genetically engineered to synergize with therapeutic antibodies. As part of the collaboration, Celularity will also evaluate ROR1-targeted CAR-NK and CAR-T cell therapies as extensions of its CYNK and CyCART programs, respectively.

08:17 EDT Phathom Pharmaceuticals secures $200M term loan facility from Hercules Capital - Phathom Pharmaceuticals (PHAT) reported it has obtained a $200 million term loan facility from Hercules Capital, Inc. (HTGC). This additional capital further strengthens Phathom's balance sheet in advance of anticipated key catalysts, including data from the pivotal PHALCON-EE Phase 3 trial of vonoprazan for the treatment of erosive esophagitis in October 2021, data from the Phase 2 trial of vonoprazan for the treatment of non-erosive reflux disease in the first quarter of 2022, and FDA approval and commercial launch of vonoprazan-based regimens for the treatment of H. pylori in the second half of 2022. This non-dilutive financing extends Phathom's projected cash runway to mid-2023 based on the Company's current operating plans. Under the terms of the $200 million term loan facility, $100 million was drawn at closing, and an additional $100 million becomes available in two tranches of $50 million each. The first $50 million tranche becomes available upon the receipt of positive data from the PHALCON-EE Phase 3 trial. The second $50 million tranche becomes available upon the occurrence of both FDA approval of a vonoprazan-based regimen for the treatment of H. pylori and FDA acceptance of filing of a new drug application for vonoprazan for the treatment of erosive esophagitis. Approximately $54 million of the initial $100 million drawn down by the Company will be used to pay off the principal of the Company's existing outstanding term loan. The new facility provides for an interest-only period of three years, which is extendable based on the achievement of certain regulatory milestones. The loan facility is secured by the Company's assets.

08:16 EDT American Airlines becomes anchor partner to Breakthrough Energy Catalyst - American Airlines announced that it has become an anchor partner to Breakthrough Energy Catalyst, investing $100 million in a groundbreaking collaborative effort to accelerate the clean energy technologies necessary for achieving a net zero economy by 2050. In becoming one of Breakthrough Energy Catalyst's first anchor partners, American is backing up its ambitious climate commitments with concrete action to accelerate the development of pivotal emissions-reduction solutions like sustainable aviation fuel. Breakthrough Energy Catalyst is a first-of-its-kind model that brings together companies, governments, and private philanthropy to accelerate the adoption of critical, next generation clean technologies. Catalyst and its partners will work together to finance, produce and buy the new solutions that will underpin a zero-carbon economy but are currently more expensive than their existing fossil-fuel emitting counterparts. The difference between these costs is what is now referred to as the "Green Premium." Catalyst will start by funding projects across four technologies: sustainable aviation fuel, green hydrogen, direct air capture and long-duration energy storage.

08:14 EDT AutoWeb announces results of research report by BPE on click traffic - AutoWeb announced the results of a research report conducted by Brian Pasch Enterprises focused on the quality of its click traffic generation product. The detailed report and accompanying visual components provide a number of insights into the high value of AutoWeb's audience and its consumer engagement levels, validating the high caliber of the company's traffic platform. AutoWeb retained BPE to conduct in-depth research on the company's click traffic generation product to identify how it fits into the larger conversation of assisting dealers in managing their online businesses to drive sales growth. In addition to incorporating its own recent research on traffic acquisition, BPE surveyed existing AutoWeb customers, tested claims of how the product works, and generated analytics reports to verify the actual delivered value matched AutoWeb's promotional collateral. The overall goal of the research was to enable BPE to accurately evaluate how AutoWeb's click traffic product performs for dealers in real world implementation. BPE's recent research into consumer phone calls generated by dealer-funded Google SEM campaigns showed that consumer intent was a mix of sales, parts and service and administrative calls. Most notably, during BPE's assessment of Google SEM traffic for dealers, it found that less than 13 percent of all Google SEM driven phone calls were attributed to an active vehicle shopper.

08:12 EDT Oracle chosen by Cablenet to monetize its products - Cablenet Communication Systems, a Cyprus-based communications service provider, leverages Oracle Communications converged charging, policy and billing solutions to quickly monetize new and existing products and deliver a better customer experience. As part of its investment in next-generation networking and IT technology, Cablenet recently implemented Oracle Communications Billing and Revenue Management along with Oracle Converged Charging and Oracle Policy Management. "As CSPs invest in the networks of tomorrow, they need cloud native, complete solutions that power real-time customer experiences and quick time to market for innovative new products," said Jason Rutherford, senior vice president and general manager, Oracle Communications, Applications. "Oracle's integrated billing, converged charging, and policy solution is providing the flexible, open platform Cablenet needs to support its exponential growth and move to 5G."

08:10 EDT Viaero Wireless selects Ericsson to upgrade network equipment - Viaero Wireless has selected Ericsson to replace and upgrade its existing LTE equipment to end-to-end 5G-ready products and solutions. With this modernization, Viaero will be able to offer upgraded mobility and broadband services, which will result in an improved customer experience. "We needed a partner that could step up and provide a turn-key solution," said Frank DiRico, CEO and Founder of Viaero. "The key to our success is providing the best possible service to our customers. In addition to Ericsson's industry-leading products and solutions, we felt that Ericsson had the best team to make this project successful when looking at different technology options."

08:08 EDT Avadel recognizes World Narcolepsy Day, announces data presentations - Avadel Pharmaceuticals announced its support of the third annual World Narcolepsy Day on Wednesday, September 22. FT218 is the Company's current lead drug candidate, an investigational formulation of sodium oxybate designed to be taken once at bedtime for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. FT218 is currently under review at the U.S. Food and Drug Administration with a Prescription Drug User Fee Act target date of October 15, 2021. In addition to supporting World Narcolepsy Day, Avadel is also participating in upcoming patient and medical conferences, including: The annual Narcolepsy Network conference, taking place virtually October 2-3 where the Company is sponsoring a virtual exhibit booth and presenting patient and clinician perspectives on how to manage the disruption of narcolepsy. The American College of Chest Physicians annual meeting, taking place virtually October 17 - 20 where new data will be shared in three poster presentations. The annual meeting of the American Neurological Association, taking place virtually October 17 - 19 where encore posters featuring post hoc analyses from the REST-ON trial will be presented.

08:08 EDT Capstone Green Energy gets order 'major' Caribbean resort redevelopment - Capstone Green Energy announced that it continues to expand the low emission microturbine market in the Caribbean with an order for a major Caribbean resort redevelopment project that includes 2.4 megawatts of C800 Signature Series microturbine energy systems. The order, secured by E-Finity Distributed Generation , Capstone's exclusive distributor for the Mid-Atlantic and Southeastern United States and parts of the Caribbean, is expected to be commissioned in the Spring of 2022. Three Capstone Green Energy propane-fueled C800 Signature Series microturbine energy systems are designed to provide a reliable, environmentally friendly, and cost-effective alternative to the island's expensive grid power. The new power plant is expected to provide all of the resort's power while potentially generating millions of dollars in estimated annual electric cost savings and reducing the resort's carbon footprint.

08:06 EDT Medicenna Therapeutics issued U.S. Patent for MDNA11 program - Medicenna Therapeutics announced that the US Patent and Trademark Office has issued U.S. Patent No. 11,117,943, titled "Superagonists and Antagonists of Interleukin-2." The patent provides intellectual property protection for methods of treating a wide range of cancers specified in the claims with interleukin-2 variants such as MDNA11, which is Medicenna's selective, long-acting and novel IL-2 super-agonist. The patent's term extends into at least 2032, without accounting for any potential extensions. Medicenna holds an exclusive world-wide license to U.S. Patent No. 11,117,943, through its previously announced agreement with Stanford University, along with additional issued and filed patents in US, Europe, Japan, China, Canada and India which provide foundational composition-type protection for its IL-2 Superkine platform, including MDNA11.

08:05 EDT NextGen Healthcare appoints David Sides as CEO - NextGen Healthcare (NXGN) announced that David Sides has been appointed president and CEO, effective September 22. Sides brings more than two decades of experience in healthcare information technology and product innovation. Most recently he served as COO of Teladoc Health (TDOC).

08:04 EDT Medavail appoints Ramona Seabaugh as CFO - MedAvail Holdings announced the appointment of Ramona Seabaugh as Chief Financial Officer effective immediately. As a key member of MedAvail's executive leadership team, Ms. Seabaugh will lead the Company's financial operations. "Ramona's pharmacy industry expertise and extensive financial leadership experience will be invaluable in executing our strategy to drive operational and financial performance," said Ed Kilroy, President and Chief Executive Officer of MedAvail. "I am pleased to welcome Ramona to our team, as we continue to expand into new geographies and transform the pharmacy experience for seniors." Ms. Seabaugh brings to MedAvail more than 20 years of experience with pharmacy and healthcare services organizations leading strategic growth initiatives. She most recently served as Vice President of Finance at Vixxo Corporation, a facilities management company. Prior to Vixxo, Ms. Seabaugh served as the Vice President of Finance at Ascension Pharmacy Services, a division within one of the largest non-profit health systems in the United States.

08:03 EDT Generac to acquire Tank Utility, terms not disclosed - Generac Holdings announced the signing of a purchase agreement to acquire the shares of Tank Utility, a provider of IoT propane tank monitoring that enables the optimization of propane fuel logistics. The deal further expands Generac's connectivity functionality and services with sophisticated remote monitoring capabilities for propane. Both generator and fuel dealers are seeing increased demand for various power products to support consumers' off-grid power needs and to protect from grid instability. Generac's propane-powered backup generators, battery storage, and home energy management offerings paired with Tank Utility's monitoring and analytics help dealers expand their expertise as total home energy advisors for homeowners and adapt to changing consumer demands for off-grid and backup capabilities. The acquisition is expected to close in October 2021.

07:56 EDT Small Pharma included in AdvisorShares Psychedlics ETF - Small Pharma announces that AdvisorShares Investments has included Small Pharma in the inaugural launch of its AdvisorShares Psychedelics ETF. PSIL invests in the emerging psychedelic drugs sector, offering exposure to biotechnology, pharmaceutical, and life sciences companies leading the way in this nascent industry. The ETF at launch includes 16 publicly listed companies offering investors exposure to companies who are leading the way in the emerging psychedelics space.

07:55 EDT TG Therapeutics announces combination data presentation at iwCLL - TG Therapeutics announced data presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia. Data highlights from each presentation are included below. The Company will also host a virtual investor and analyst event today, September 20, 2021 at 8:30 AM ET, to review the updated Phase 1 data evaluating the investigational combination of UKONIQ and ublituximab plus venetoclax presented at iwCLL, as well as provide an overview of the ULTRA-V Phase 2/3 trial. Oral Presentation Title: Umbralisib Plus Ublituximab Is Superior to Obinutuzumab Plus Chlorambucil in Patients with Treatment-Naive and Relapsed/Refractory Chronic Lymphocytic Leukemia: Results from the Phase 3 UNITY-CLL Study: 421 patients were randomized to the U2 or O+Chl arms; 57% of patients were treatment-naive and 43% had relapsed/refractory CLL. At a median follow-up of 36.7 months, U2 significantly prolonged independent review committee assessed progression-free survival vs O+Chl. PFS improvement with U2 vs O+Chl was consistent across all subgroups examined including treatment naive patients and relapsed/refractory patients. Overall response rate was significantly higher with U2 compared to O+Chl. For the U2 arm, at a median treatment exposure of 21 months, most adverse events were Grade 1 or 2 in severity and were relatively balanced between the treatment naive and previously treated populations. Grade 3/4 Adverse Events of clinical interest included elevated ALT, elevated AST, non-infectious colitis, infectious colitis, pneumonitis, rash, and opportunistic infections. Oral Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia. Regimen was administered with 3 cycles of U2 as induction in cycles 1 through 3, U2 plus venetoclax in cycles 4, 5 and 6, followed by umbralisib plus venetoclax in cycles 7 through 12 in patients with relapsed or refractory CLL. Patients with centrally confirmed undetectable minimal residual disease in the bone marrow after cycle 12 were permitted to stop all therapy, while MRD detectable patients continued on single agent umbralisib. 47 patients have now been treated as of the data cutoff with 57% of patients previously exposed to a BTK inhibitor. Best Overall Response Rate was 100% amongst evaluable patients, including 37% complete response rate. At cycle 12, 91% of patients achieved undetectable minimal residual disease in the peripheral blood, and 72% of patients achieved uMRD in the bone marrow. At a median follow up of 24.5 months, median progression-free survival has not been reached. Grade 3/4 adverse events occurring in greater than5% of patients were neutropenia, leukopenia, lymphocytopenia, infusion related reactions, diarrhea, and anemia. No TLS events were observed during venetoclax administration. Oral Poster Presentation Title: TG-1701, a Selective Bruton Tyrosine Kinase Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib in Patients with Chronic Lymphocytic Leukemia. A total of 50 patients with R/R CLL have been treated with TG-1701, with patients receiving monotherapy in the dose-escalation cohort, 200 mg in a dose-expansion cohort, 300 mg in a dose-expansion cohort, or TG-1701 in combination with U2 in the dose escalation cohort. TG-1701 monotherapy was well tolerated and the maximum tolerated dose was not reached up to 400 mg QD. Grade 3/4 AEs occurring in patients treated with 200 mg QD of TG-1701, included neutropenia, anemia and arthralgia. Grade 3/4 AEs occurring in patients treated with 300 md QD of TG-1701, included neutropenia, COVID-19, ALT increased and AST increased. 100% ORR observed in the 300 mg QD monotherapy expansion cohort at a median follow up of 12 months. 95% ORR observed in the 200 mg QD monotherapy expansion cohort at a median follow up of 19 months. 100% ORR observed in the 1701+U2 dose escalation at a median follow up of 19 months. Poster Presentation Title: Phase I/II Study of Umbralisib, Ublituximab, and Pembrolizumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Richter's Transformation: 5-Year Follow-up: A total of 20 patients with R/R CLL or Richter's Transformation were treated with the triple combination of ublituximab, umbralisib, and pembrolizumab. Patients with CLL received 2 cycles of the U2 regimen before pembrolizumab was added for an additional 4 cycles, followed by umbralisib maintenance. Patients with RT received U2 + pembrolizumab for the first 4 cycles, followed by U2 maintenance. Twenty patients were evaluable for safety and 19 were evaluable for efficacy. The triple combination was well tolerated, with immune mediated toxicities not appearing above what would be expected with either umbralisib or pembrolizumab alone. Grade 3/4 AEs occurring in greater than20% of patients include, neutropenia, thrombocytopenia, ALT increase, leukopenia, nausea, fatigue, and anemia. In this heavily pre-treated cohort with a median of 2 prior lines of therapy: 91% ORR in patients with R/R CLL. 83% ORR in BTK refractory CLL patients, with 4 of 5 responders achieving a response to U2 alone at the patient's first efficacy assessment, prior to the addition of pembrolizumab. 25% ORR in patients with RT, including 25% CR rate.

07:47 EDT Mindset announces preclinical results for MSP-4018 - Mindset Pharma announced that preclinical proof-of-concept data comparing its clinical candidate, MSP-4018, against 5-MeO-DMT further demonstrated strong efficacy and an improved safety profile as a next generation psychedelic medicine. "Given the strong preclinical efficacy and safety data in support of MSP-4018, combined with our expedited manufacturing process, we believe our Family 4 clinical candidate has the potential to provide a safer and more scalable therapeutic alternative to first-generation 5-MeO-DMT. We believe this preclinical data will enable us to quickly advance this novel compound into human clinical trials," said James Lanthier, CEO of Mindset. Mindset's Family 4 compounds are DMT and 5-MeO-DMT-inspired novel drug candidates that offer a broad range of pharmacological diversity suitable for in-clinic settings. The Company has run a battery of specialized in-vitro and in-vivo tests on its patent-pending novel compounds to select the optimal psychedelic drug candidates for progressing towards human clinical trials.

07:45 EDT Document Security to change name to DSS, Inc. - Document Security Systems announced it is changing its name to DSS, Inc. The name change will become effective on September 30, 2021. "Over the past two years, we have undergone sweeping change to our organizational structure, operating companies, and business plan," stated Frank D. Heuszel, CEO of DSS. "Today, document security products and services represent only a small fraction of our operations and continuing to operate under the Document Security Systems brand obfuscates the multiple high-growth business lines we have added, including healthcare, real estate, renewable energy, and securitized digital asset initiatives. We are excited to move forward under the new DSS, Inc. name to more accurately reflect our broad and increasingly diverse portfolio of current and future businesses."

07:44 EDT Intra-Cellular announces publications on mechanism of action of lenrispodun - ntra-Cellular Therapies highlights the publication of four manuscripts that report on the mechanism of action of lenrispodun and the potential cardiovascular therapeutic effects of Phosphodiesterase Type I inhibition. The first manuscript entitled "Acute Hemodynamic Effects and Tolerability of Phosphodiesterase-1 Inhibition With ITI-214 in Human Systolic Heart Failure" was published online in Circulation: Heart Failure. This manuscript reports on the findings of study ITI-214-104. This was the first study of a PDE1 inhibitor in patients with heart failure with reduced ejection fraction. Acute, single oral doses of lenrispodun increased mean left ventricular power index, cardiac output and heart rate while inducing systemic arterial vasodilation. Importantly, lenrispodun was well-tolerated in these patients. The hemodynamic profile of acute lenrispodun in humans was analogous to that reported in our animal preclinical studies. Topline data from this study has previously been presented. The second manuscript entitled "PDE1 inhibition modulates Cav1.2 channel to stimulate cardiomyocyte contraction" was published online in Journal Circulation Research. This manuscript describes studies in cardiomyocytes that express the PDE1C isoform, the predominant isoform in human heart, and elucidates a mechanism by which lenrispodun increases cardiac contractility. New findings in this study reveal that the action of lenrispodun, our PDE1 inhibitor, improves cardiac contractility by activating protein kinase A, results in increased L-type calcium channel conductance but does not require changes in other intracellular calcium stores. The findings of these two studies indicate that PDE1 inhibition caused by lenrispodun may provide a positive inotropic therapy for heart failure which is mediated by a novel mechanism of action. The third manuscript entitled "Selective PDE1 inhibition ameliorates vascular function, reduces inflammatory response, and lowers blood pressure in ageing animals" was published online in the Journal of Pharmacology and Experimental Therapeutics. This manuscript describes the acute and chronic effects of PDE1 inhibition using lenrispodun on prominent aging related changes in macro- and micro- circulation and inflammatory status in a mouse model of accelerated aging involving a genetic deletion yielding a reduction in the activity of the DNA repair enzyme, ERCC1 endonuclease. This accelerated aging model enables pharmacotherapy during the entire course of the aging process. This study showed that lenrispodun treatment reduced age-related elevated vasoconstriction of the aorta, and coronary arteries, and as a consequence increased blood flow in the microcirculation in these mice. In addition, lenrispodun reduced cardiac hypertrophy and levels of pro-inflammatory but not anti-inflammatory cytokines in this model. The fourth manuscript entitled "Vascular Ageing Features Caused by Selective DNA Damage in Smooth Muscle Cell." was published online in Oxidative Medicine and Cellular Longevity. This manuscript describes studies using a model of accelerated aging similar to the one described above but where the activity of the Ercc1 enzyme was selectively knocked out only in smooth muscle and not in the entire body. These SMC- Ercc1undefined/- mice show a progressive aging phenotype in resistant and conduit arteries. Importantly, PDE1 inhibition by lenrispodun normalizes vasodilator function in progressive vascular smooth muscle dysfunction in this mouse model. Stiffening of arteries, vascular endothelial dysfunction, and increased inflammation may represent important risk factors for cardiovascular disease. The ability of lenrispodun to ameliorate these deficits, if translated to humans, suggests a potential therapeutic utility in treating arteriopathy associated with aging.

07:41 EDT Bitcoin slumps below $44,000, crypto names fall in pre-market trading - The price of bitcoin is down by over 1%, falling below the $44,000 level, according to data from Coindesk. This marks a one-week low for the crypto-currency. Stocks levered to bitcoin prices including Riot Blockchain (RIOT), Marathon Digital (MARA), and Coinbase (COIN) are down 6.2%, 8.5%, and 3.3% respectively in pre-market trading.

07:38 EDT Vision Marine Technologies to showcase E-Motion electric outboard motor - Vision Marine Technologies announced it will showcase its E-Motion electric outboard motor at IBEX 2021, taking place September 28 to September 30 in Tampa, Florida. "We are pleased to announce an industry first where our E-Motion outboard motor will be implemented into third-party power boats and pontoons at this year's IBEX. Over the course of the three day event at IBEX, global OEM leaders of the marine industry will have a chance to sea trial our impressive product," said Alexandre Mongeon, CEO of Vision Marine Technologies.

07:36 EDT Ayr Wellness opens new dispensary in West Pensacola - Ayr Wellness announced the opening of Liberty Health Sciences West Pensacola, the Company's 41st operating dispensary in Florida. The West Pensacola dispensary is located at 2146 W. 9 Mile Rd, Pensacola, Florida. The 1,330 sq. ft. retail store expands the Company's presence in the important Pensacola market, the westernmost city in the Florida Panhandle and one of the largest metropolitan areas in the Gulf Coast region with a population of over 500,000.

07:36 EDT BeyondSpring announces Phase 3 DUBLIN-3 study met primary endpoint - BeyondSpring will have a late-breaking oral presentation at the European Society for Medical Oncology 2021 Congress. This includes the final intention-to-treat dataset from the Company's DUBLIN-3 Phase 3 registrational trial of its first-in-class lead asset, plinabulin, in combination with docetaxel vs. docetaxel alone for the treatment of 2nd/3rd line non-small cell lung cancer patients with EGFR wild type. Plinabulin is a selective immunomodulating microtubule-binding agent, which is a potent antigen presenting cell inducer. The DUBLIN-3 Phase 3 trial is a randomized, active controlled, single blind to patients, global trial that enrolled 559 patients in 2nd and 3rd line NSCLC, EGFR wild type, with a measurable lung lesion. Patients were treated on a 21-day cycle with infusion of docetaxel or with docetaxel alone. The primary endpoint of OS was met in the ITT population. The following summarizes the clinical results: Primary endpoint: mean OS months: DP 15.08 M vs. D 12.77 M; p=0.0332; median OS: DP 10.5 M vs. D 9.4 M; Log-rank p=0.0399; HR = 0.82. Key secondary endpoints: ORR; PFS: mean : DP 6.0 M vs. D 4.4 M; p=0.006; median: DP 3.6 M vs. D 3.0 M; Log-rank p=0.008; HR=0.76; Incidence of Grade 4 neutropenia, cycle 1 day 8, DP: 5.3% vs. D: 27.8%; pless than0.0001; 24 Month OS rate DP: 22.1% vs. D: 12.5%; p = 0.0072; 36 Month OS rate DP: 11.7% vs. D: 5.3%; p = 0.0393; 48 Month OS rate DP: 10.6% vs. D: 0%; p value cannot be calculated; Q-TWiST - Quality-adjusted Time Without Symptoms of Disease and Toxicity DP: 12.40 M vs. D: 10.47 M; 18.43% relative gain in Q-TWiST, p=0.0393. Subset Analyses: PD-1/PD-L1 exposed patients DP: n=62; D: n=67; approx. 50% China/50% Western; mean OS: DP 18.33 M vs D 13.97 M; p= 0.0602; median OS 95% CI: DP 12.3 M (9.34, 22.88; D 12.1 M; Log-rank p = 0.0643; HR = 0.68; 24 Month OS rate: DP: 35.8% vs. D: 11.9%; p = 0.0026; 36 Month OS rate DP: 12.5% vs. D: 5.0%; p = 0.2676. 48 Month OS rate, Safety: DP is well tolerated, with lower grade 4 and grade 3/4 AE events per patient per year vs. D. No unexpected AE concerns were identified.

07:32 EDT Shyft Group opens new research, development center - The Shyft Group announced the opening of a dedicated research and development center, located at 47632 Halyard Drive, Plymouth, Michigan. The 40,000-square-foot R&D facility will be home to Shyft Innovations, The Shyft Group's dedicated mobility research and development team, which includes the EV Chassis Engineering group. The building will be used for product development, prototyping, and design, with a focus on a range of future products and leading technologies. An all-electric chassis platform is currently under development. Early prototypes will be assembled at the facility to support the EV chassis' soft launch towards the end of 2022. The facility will officially open on September 20, 2021.

07:29 EDT Equinox Gold announces results for PFS for Aurizona expansion - Equinox Gold announce the results of a Pre-Feasibility Study, or PFS, for an expansion at the company's 100%-owned Aurizona Gold Mine located in Brazil. By mining the underground and satellite open-pit deposits concurrently with the existing Piaba open-pit, the expansion would extend the Aurizona mine life to 11 years with average annual production of 137,000 ounces of gold per year and total life-of-mine production of 1.5M oz of gold. Peak production in years 2026 to 2029 averages more than 160,000 oz of gold per year. Updated Mineral Reserve and Resource estimates for Aurizona, incorporating the new underground and open-pit deposits and offsetting 18 months of mining depletion, show a 73% increase over the December 31, 2019 estimate with 1.7 million oz of Proven & Probable Mineral Reserves grading 1.60 grams per tonne gold plus 868,000 oz of Measured & Indicated Mineral Resources grading 1.49 g/t gold. Christian Milau, CEO of Equinox Gold, stated: "Incorporating the Aurizona underground and satellite deposits into our mine plan will nearly double the Aurizona mine life, increase annual production and generate almost $1 billion of net cash flow at current gold prices. I am incredibly proud of what our team has accomplished at Aurizona. The expansion will create additional economic and social opportunities for our community partners and substantial value for our shareholders, with significant potential for further growth as we continue to explore what could eventually be a multi-decade mine."

07:24 EDT Molina Healthcare targets long-term EPS growth of 15%-18% - Also targets net income growth of 13%-16% and Premium revenue growth of 13%-15%. Outlook taken from Investor Day presentation slides on Friday.

07:19 EDT Delta 9 Cannabis opens sixteenth cannabis store - DELTA 9 CANNABIS is pleased to announce the grand opening of its sixteenth Delta 9 Cannabis retail store, and eleventh cannabis store in the Province of Manitoba. Delta 9's newest retail store is located in the City of Winnipeg and is scheduled to open on September 23, 2021.

07:18 EDT Canaan announces up to $20M share repurchase program - Canaan announced that its board of directors has authorized a share repurchase program under which the Company may repurchase up to $20M worth of its outstanding American depositary shares, each representing 15 Class A ordinary shares, and/or Class A ordinary shares over the next 12 months starting from September 20, 2021. Nangeng Zhang, Chairman and Chief Executive Officer of Canaan, commented, "Canaan remains committed to driving value for shareholders. Given our robust business performance in 2021 to date and encouraging outlook, we believe our current valuation does not fully reflect the growth potential of the Company. As such, we would like to allocate our capital to optimize value creation, in addition to our consistent investment for market expansion, securing production capacity, and R&D innovation. The new share repurchase program demonstrates our strong confidence in both the Company's business operation and long-term prospects of the industry."

07:17 EDT Glaukos announces licensing agreement with Attillaps Holdings, no terms - Glaukos announced that it has entered into a licensing agreement with Attillaps Holdings, Inc. under which Attillaps has granted Glaukos a global exclusive license to research, develop, manufacture and commercialize Attillaps' proprietary library of investigational pharmaceutical compounds that target the eradication of Demodex mites, which are the root cause of Demodex blepharitis and often associated with meibomian gland dysfunction and related ophthalmic diseases. Demodex blepharitis and Demodex-driven meibomian gland dysfunction are caused by an infestation of Demodex mites, the most common ectoparasite found on human skin. Demodex blepharitis is characterized by eyelid inflammation and irritation resulting in eyelid redness, discomfort and debris. Demodex-driven meibomian gland dysfunction is characterized by decreased lipid secretion into the tear film and is a leading cause of dry eye disease. Under the agreement, Glaukos has the exclusive global right to research, develop, manufacture and commercialize products using certain acetylcholinesterase, AChE, inhibitors for the treatment of ophthalmic diseases caused by Demodex mites. Attillaps' lead compounds have demonstrated promising in-vitro results in preclinical settings. "This licensing agreement adds a promising therapeutic class that expands the focus of our emerging Corneal Health franchise into new and globally underserved disease indications," said Thomas Burns, Glaukos president and chief executive officer. "Attillaps' proprietary compounds and targeted ophthalmic indications are highly complementary to our expanding portfolio of sustained pharmaceuticals and represent a synergistic fit with our ongoing Corneal Health R&D initiatives." "We are incredibly excited about the development and commercial prospects of our novel platform in various therapeutic applications, particularly in the ophthalmology sector," said Frank Spallitta, founder and chief executive officer of Attillaps. "Glaukos is a world-class ophthalmic company, and we couldn't envision a more compelling licensing partner to advance our platform as a potential solution for the many patients suffering from these challenging conditions that currently have no approved treatments." Financial terms of the agreement were not disclosed.

07:15 EDT Plug Power to build largest green hydrogen production facility on West Coast - Plug Power is expanding its green hydrogen ecosystem to the west coast with the construction of a new state-of-the-art production facility in Fresno County, California. Green hydrogen is produced through the electrolysis of water with electricity generated from zero-carbon sources and only harmless oxygen is emitted during the process. As the largest green hydrogen production facility on the west coast, the plant will produce 30 metric tons of liquid green hydrogen daily, serving customers from San Diego to Vancouver. The facility will use a new 300 megawatt zero-carbon solar farm to power 120 megawatts of Plug Power's state-of-the-art PEM electrolyzers, which split water into hydrogen and oxygen through an electro-chemical process. The California plant joins the company's growing national network of plants in New York, Tennessee, and Georgia that will supply 500 tons per day of liquid green hydrogen by 2025, replacing 4.3 million metric tons of carbon dioxide emissions, and 1,000 tons per day globally by 2028. When fully built, the network of plants in the U.S. will offer transportation fuel to customers that is price-competitive with diesel. Plug Power's investment in green hydrogen production will contribute to decarbonizing light-duty vehicles, freight-transportation, and logistics operations, and supports California's leading role in developing hydrogen as a zero-emission fuel. The project includes construction of a new tertiary wastewater treatment plant in the city of Mendota that will provide recycled water for the people of Mendota and supply the full needs of the plant. Pending environmental and construction permitting approvals, the plant will break ground in early 2023 and complete commissioning in early 2024.

07:14 EDT Polaris selects TrackX as vehicle inventory management solution - TrackX Holdings announced that Polaris has selected the Company's technology platform as its corporate vehicle inventory system of record. This announcement represents a significant expansion of the two companies' long-standing partnership. Included in this expansion, TrackX becomes the source of record for vehicle inventory by integrating with multiple systems and disparate GPS-tracking systems.

07:14 EDT GameStop to hire up to 500 people at new customer center in Pembroke Pines, FL - GameStop announced that the Company plans to hire up to 500 employees at its newly-leased customer service center in Pembroke Pines, Florida. The new facility is expected to be operational by the end of 2021. The facility will be an integral part of the Company's U.S.-based customer care operations.

07:12 EDT Etihad Guest launches MilesBooster program powered by Points International - Etihad Guest, the loyalty programme of the UAE's national airline, Etihad Airways, has launched a new programme feature, MilesBooster, powered by Points. MilesBooster lets members multiply miles they have earned from almost any activity - from previous flights or even non-travel related expenditures such as credit card transactions and everyday purchases. Members have the option to double or triple miles earned in the past 12 months when they pay a special mileage rate. Those who take advantage of this new member benefit can boost up to 150,000 miles a year depending on their tier status.

07:10 EDT Alvarium Tiedemann to become public through Cartesian Growth combination - Tiedemann Group, Alvarium Investments and Cartesian Growth, jointly announced entry into a definitive business combination agreement. This proposed transaction will form Alvarium Tiedemann. Alvarium Tiedemann's common stock is expected to be publicly traded on Nasdaq under the ticker symbol (GLBL) following the closing of the transaction, which is anticipated in the first quarter of 2022. Alvarium Tiedemann will be headquartered in New York. The transaction is expected to create a combined company with a pro forma equity value of $ 1.4B and will be funded through a combination of Cartesian's cash in trust and approximately $165M fully committed purchase of shares of common stock of Cartesian pursuant to a private investment in public equity. The PIPE capital commitments have been obtained from institutional investors and strategic partners of both Alvarium and the Tiedemann Group. Cartesian has $345M of cash in its trust account. Over 96% of equity held by active operating partners is expected to be rolled into the combined company, with all proceeds from this transaction being used for capital structure optimization. All references to available cash from the trust account and retained transaction proceeds are subject to any redemptions by the public shareholders of Cartesian and payment of transaction expenses. The respective boards of the Tiedemann Group, Alvarium and Cartesian have unanimously approved the proposed business combination. Completion of the proposed business combination is expected in Q1 2022. The transaction will be effected pursuant to the terms and conditions of the business combination agreement, which contains customary closing conditions, including, without limitation, the registration statement being declared effective by the Securities and Exchange Commission, receipt of regulatory approvals in certain jurisdictions where the Tiedemann Group and Alvarium operate, and approval by the shareholders or members, as applicable, of the Tiedemann Group, Alvarium and Cartesian.

07:09 EDT CarLotz announces first hub in Georgia - CarLotz announced it will open its first hub in Georgia today. "We are so happy to open our first hub in Georgia and become a part of the Atlanta community," said Michael Bor, Co-Founder and CEO of CarLotz. "Our continued national expansion will allow even more guests to be a part of CarLotz's peer-to-peer marketplace, our full omnichannel approach and the real service and value that comes with buying and selling through our unique consignment model," Bor continued.

07:08 EDT Innovative Industrial acquires Missouri property, for $1.53M, in lease with CPC - Innovative Industrial Properties IIP announced that it closed on the acquisition of a property in Missouri, and entered into a long-term lease with CPC of Missouri - Smithville, a subsidiary of Calyx Peak .The purchase price for the property was $1.53M. CPC is expected to construct approximately 83,000 square feet of industrial space at the property, for which IIP has agreed to provide reimbursement of up to $26.72 M. Assuming full reimbursement for the construction, IIP's total investment in the property is expected to be $28.25M. CPC intends to operate the property upon completion of construction as a licensed cannabis cultivation and processing facility. "We are excited to announce this new long-term real estate partnership with Calyx, expanding our footprint into Missouri as our 19th state," said Paul Smithers, President and Chief Executive Officer of IIP. "Calyx has developed a strong reputation for quality, award-winning cannabis products in California, and we look forward to working closely with the Calyx team in coming months on the development of this new state-of-the-art facility in Missouri, as Calyx expands its operational platform to meet the tremendous growth in demand from patients throughout the state." Calyx currently operates a 235,000 square foot cannabis cultivation facility in California, and expects to begin construction on a dispensary location in southern California in the near future. Calyx also has a Tier 3 cultivation license and a provisional adult-use dispensary license in Massachusetts, and expects to open a dispensary in the West Plaza neighborhood of Kansas City, Missouri later this year. Founded in 2016, Calyx is headquartered in Massachusetts and plans to be vertically integrated in three states by the end of 2022. "We are thrilled to enter into this long-term real estate partnership with IIP for the development of this new facility in Missouri," said Erin Carachilo, CEO of Calyx, and Lee Hoffman of CPC. "While less than one year since the launch of Missouri's medical cannabis program, we have witnessed a tremendous rate of adoption by patients and growth in sales throughout the state, and look forward to completing the development of this facility, which will be designed with next-generation systems in a highly controlled environment that will enable us to bring our premium, diversified genetics at scale to Missouri patients."

07:06 EDT Live Oak Acquisition II extends tender offer related to combination with Navitas - Live Oak Acquisition Corp. II announced that it is extending its previously announced offer to acquire all issued and allotted ordinary shares and preferred shares of Navitas Semiconductor Limited until October 15, 2021, New York City time, unless the offer is further extended or withdrawn by Live Oak II. Live Oak II is making the offer pursuant to a Business Combination Agreement and Plan of Reorganization, dated as of May 6, 2021, by and among Live Oak II, a wholly owned subsidiary of Live Oak II, and Navitas whereby the parties intend to effect a business combination between Live Oak II and Navitas, on the terms and subject to the conditions set forth therein. Except for the extension of the tender offer, all other terms and conditions of the tender offer remain the same as set forth in the Offer to Acquire dated July 9, 2021 and the related letter of transmittal.

07:05 EDT Verastem announces clinical collaboration with Amgen in NSCLC treatment - Verastem (VSTM) announced a clinical collaboration agreement with Amgen (AMGN) to evaluate the combination of VS-6766, Verastem Oncology's investigational dual RAF/MEK inhibitor, with Amgen's KRAS G12C inhibitor Lumakras in KRAS G12C-mutant non-small cell lung cancer, or NSCLC. The Phase 1/2 trial will evaluate the safety, tolerability and efficacy of VS-6766 in combination with Lumakras in patients with KRAS G12C-mutant NSCLC who have not been previously treated with a KRAS G12C inhibitor as well as in patients who have progressed on a KRAS G12C inhibitor. The study will therefore investigate the potential benefits of a more complete vertical blockade of the RAS pathway with the combination of VS-6766 with Lumakras in KRAS G12C-mutant locally advanced or metastatic NSCLC. Verastem Oncology expects to initiate the clinical trial with VS-6766 and Lumakras by the end of 2021.

07:04 EDT Farmland Partners shares impact from Hurricanes Ida, Nicholas - Farmland Partners announced that over the past few weeks, the Delta region, and Louisiana in particular, has been hit by Hurricanes Ida and Nicholas. While there was substantial rain on the Company's farms in the region, none of the company's farms suffered significant damage from the storms. The company also shared information on its lease renewal cycle. Lease Renewals: Total portfolio: Approximately 158,000 acres owned and approximately 8,300 acres managed; 2021 Renewals: Approximately 40,100 acres, or approximately 27% of total owned portfolio; 2021 Renewals Completed: Approximately 23,250 acres, or 59% of renewals; and Renewal Trends: Weighted average increase of approximately 10% to 11%. The Company's lease renewals signed in 2021 generally commence in Q4 and, accordingly, contribute to revenue to a greater extent in 2022 and beyond than in 2021.

07:04 EDT Verastem announces clinical collaboration with Amgen in NSCLC treatment - Verastem (VSTM) announced a clinical collaboration agreement with Amgen (AMGN) to evaluate the combination of VS-6766, Verastem Oncology's investigational dual RAF/MEK inhibitor, with Amgen's KRAS G12C inhibitor Lumakras in KRAS G12C-mutant non-small cell lung cancer, or NSCLC. The Phase 1/2 trial will evaluate the safety, tolerability and efficacy of VS-6766 in combination with Lumakras in patients with KRAS G12C-mutant NSCLC who have not been previously treated with a KRAS G12C inhibitor as well as in patients who have progressed on a KRAS G12C inhibitor. The study will therefore investigate the potential benefits of a more complete vertical blockade of the RAS pathway with the combination of VS-6766 with Lumakras in KRAS G12C-mutant locally advanced or metastatic NSCLC. Verastem Oncology expects to initiate the clinical trial with VS-6766 and Lumakras by the end of 2021.

07:01 EDT Bristol-Myers: FDA accepts priority review for relatlimab/nivolumab BLA - Bristol Myers Squibb announced that the U.S. Food and Drug Administration has accepted for priority review the Biologics License Application for the LAG-3-blocking antibody relatlimab and nivolumab fixed-dose combination, administered as a single infusion, for the treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022. The BLA submission was based on the efficacy and safety results of the Phase 2/3 RELATIVITY-047 trial, which demonstrated a statistically significant and clinically meaningful progression-free survival benefit of a combination therapy over standard of care anti-PD-1 monotherapy in metastatic melanoma. Relatlimab is the first LAG-3-blocking antibody to demonstrate a clinical benefit for patients with Phase 3 data. Primary results from the RELATIVITY-047 trial were presented in an oral session during the American Society of Clinical Oncology Annual Meeting in June 2021 and were selected for the official ASCO press program. The fixed-dose combination of relatlimab and nivolumab is an investigational therapy and is not approved for use in any country.

06:57 EDT Materion to acquire H.C. Starck's Electronic Materials portfolio - Materion Corporation announced that it has entered into an agreement to acquire H.C. Starck Solutions' electronic materials business, located in Newton, Massachusetts. HCS-Electronic Materials utilizes proprietary technology and extensive material science know-how to deliver tantalum- and niobium-based premium products and services for the semiconductor, industrial, and aerospace & defense markets. HCS-Electronic Materials is a provider of high-quality, high-purity tantalum sputtering targets, important in the manufacture of today's leading-edge semiconductor chips. Building on Materion's existing portfolio of electronic materials and premium thin film target solutions, the acquisition will significantly enhance the company's position as a leading supplier to the high-growth semiconductor industry. HCS-Electronic Materials adds advanced manufacturing processes and technical capabilities necessary to meet the rapidly evolving technology challenges involved in delivering today's most advanced chip architectures and important applications for the industrial and aerospace & defense markets. HCS-Electronic Materials is expected to generate revenue of approximately $145 million in 2021, adding over 19% in Value-Added Sales, and adjusted EBITDA of approximately $29 million, representing an adjusted EBITDA margin of approximately 20%. The addition is expected to be immediately accretive to Materion's adjusted EBITDA margin by 100 basis points. The purchase price of $380 million reflects an approximate 13x estimated 2021 adjusted EBITDA multiple before synergies, and an approximate 10x estimated adjusted EBITDA multiple including projected run-rate synergies. Following closing of the transaction, HCS-Electronic Materials will be part of Materion's Advanced Materials segment. The transaction is expected to be immediately accretive to Materion's adjusted EPS and adjusted EBITDA margins by 100 basis points, and is expected to increase annual value-added sales by over 19%; in addition, the company expects synergies to meaningfully contribute to EBITDA; targeting approximately $10M by 2026 The acquisition of HCS-Electronic Materials builds on Materion's acquisition of Optics Balzers in 2020, which expanded the company's global position in optical thin film coatings, furthering its transformation to a leading advanced materials supplier. The acquisition of HCS-Electronic Materials is structured as an equity purchase. Materion expects to finance the transaction utilizing a new term loan along with borrowings from its revolving credit agreement. Pro forma net debt to adjusted EBITDA is expected to be approximately 2.9x at the time of close, within the company's stated target leverage range of 1.5x to 3.0x. Materion expects to generate strong cash flow and deploy it towards deleveraging to the middle of the range within 24 months post close. The transaction is expected to close in the fourth quarter of 2021, subject to customary closing conditions, including regulatory approval.

06:50 EDT Independence Contract Drilling signs drilling contract to reactivate 16th rig - Independence Contract Drilling announced that it has signed a drilling contract for the reactivation of its 16th rig which will work in the Permian Basin, with a scheduled start date in mid-October. Anthony Gallegos, president and CEO commented, "Overall oil and natural gas market fundamentals and demand for ICD rigs continues to improve. After this most recent reactivation, which will be of a 200 series rig, future reactivations will focus on our 300 series rigs. We expect to reactivate at least one additional 300 series rig by year end. On the dayrate front, rates continue to move upward across our fleet with rates on our most recent awards rating over $3,000 per day higher than our second quarter 2021 reported averages. With our intentional focus on short term contract tenors to capture continued dayrate growth in an improving market, the vast majority of our rigs are scheduled to reprice at least once during the remainder of the year. This along with additional repricing opportunities in 2022 and an increasing percentage of our working fleet being comprised of 300 series rigs, sets up nicely for ICD operating results as we move into 2022."

06:47 EDT Pfizer, BioNTech announce results from trial of COVID-19 vaccine in children - Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 microgram administered 21 days apart, a smaller dose than the 30 microgram dose used for people 12 and older. The antibody responses in the participants given 10 microgram doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 microgram doses. The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. These are the first results from a pivotal trial of a COVID-19 vaccine in this age group. The data summarized from this Phase 2/3 study, which is enrolling children 6 months to 11 years of age, was for 2,268 participants who were 5 to 11 years of age and received a 10 microgram dose level in a two-dose regimen. In the trial, the SARS-CoV-2-neutralizing antibody geometric mean titer was 1,197.6, demonstrating strong immune response in this cohort of children one month after the second dose. This compares well to the GMT of 1146.5 from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 microgram. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age. Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration, European Medicines Agency and other regulators as soon as possible. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group. A request to the EMA to update the EU Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial - children 2-5 years of age and children 6 months to 2 years of age - are expected as soon as the fourth quarter of this year. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.

06:38 EDT ChromaDex announces preclincal research findings from CERP - ChromaDex announced findings from recently published preclinical studies, as well as recently registered clinical research, investigating Niagen in various health outcomes. Through the industry-leading ChromaDex External Research Program, ChromaDex supplies Niagen to researchers around the world at no cost to help advance the understanding of NR's impact on various age-related health conditions. A recent publication in the journal Pharmaceutics found that preventative, systemic administration of NR improved retinal ganglion cell survival in both acute and chronic preclinical models of glaucoma. This is the first study to demonstrate that systemic treatment with NR is protective in acute and chronic models of RGC damage and builds on the growing body of preclinical evidence on NR's role in eye health. A second newly published study in the Proceedings of the National Academy of Sciences, demonstrated administration of NR in a mouse model of Alzheimer's Disease increased brain NAD+ levels and reduced neuroinflammation, DNA damage, and cellular senescence. NR also improved learning and memory in the AD mice. Overall, these findings provide important insights into the interconnection between NR, cellular senescence, and neuroinflammation in AD and warrant further investigation. A third study published in Frontiers in Cardiovascular Medicine investigated the efficacy of cardioprotective compounds such as fingolimod, empagliflozin, melatonin, and NR, in a mouse model of cardiac ischemia-reperfusion injury. Of the compounds tested, only acute administration of NR significantly reduced cardiac IRI in the presence of clinically relevant anesthesia and anticoagulation therapy such as fentanyl, midazolam, and cangrelor. Therefore, the researchers suggested NR is most suitable for a multitarget cardioprotective strategy. However, further research is necessary to test the efficacy of NR prior to clinical use. In addition, ChromaDex is the supplier of Niagen for two recently registered trials on ClinicalTrials.gov. The first trial is investigating the effect of dietary supplementation of NR in children with ataxia-telangiectasia, with the main focus on neurological symptoms. The second trial is exploring whether combined treatment of exercise and Niagen will show greater improvements in skeletal muscle mitochondrial metabolism compared to exercise alone.

06:38 EDT Synlogic announces data from studies evaluating SYNB1618, SYNB1934 - Synlogic announced data from clinical studies evaluating both SYNB1618 and SYNB1934, investigational Synthetic Biotic medicines for the treatment of phenylketonuria, or PKU. SYNB1618 demonstrated clinically meaningful reductions of phenylalanine, or Phe, at several dose levels, across multiple time points, in an interim analysis of the Phase 2 SynPheny-1 study. SYNB1934, an optimized strain evolved from SYNB1618, demonstrated two-fold higher activity than SYNB1618 in a head-to-head Phase 1 study in healthy volunteers, as measured by biomarkers of Phe metabolism. Synlogic intends to incorporate SYNB1934 into an arm of the Phase 2 SynPheny-1 trial with final results expected in the first half of 2022. Based on the favorable clinical data from the SYNB1618 and SYNB1934 programs available to date, the company intends to initiate planning for a pivotal Phase 3 study for the most promising strain. Synpheny-1 is an open-label, single arm Phase 2 study in patients with PKU. The study evaluated a dose-ramp regimen consisting of four dose levels of SYNB1618 over 15 days of treatment. The primary endpoint was reduction of the area under the curve, or AUC, for plasma D5-phenylalanine after a meal challenge. Secondary endpoints include changes from baseline in fasting levels of plasma Phe at multiple timepoints, and incidence of treatment-emergent adverse events, or TEAEs. Dietary intake of Phe was carefully managed during the study through individualized diet management plans. The interim analysis included eight patients. Clinical results demonstrated meaningful reductions of Phe, consistent with prospective biomarker-driven modeling. These results included: 20% reduction in fasting plasma Phe after 14 days of dosing, at a dose of 1e12 live cells. Fasting plasma Phe level began to trend down after seven days of dose titration, at a dose up to 3e11 live cells, and was statistically significant at the 1e12 dose at day 14. There was a 40% reduction in labeled plasma D5-Phe after meal challenge at day 15, at a dose of 2e12 live cells and rebound of plasma Phe levels following cessation of dosing, confirming therapeutic effect. Safety and tolerability were consistent with prior studies, with no serious adverse events or systemic events of any kind. AEs were primarily GI related and mild to moderate in nature. There were no treatment drug related discontinuations. SYNB1934 was evolved from SYNB1618 to potentially provide increased Phe lowering activity for patients living with PKU. Clinical studies of SYNB1934 were initiated following preclinical in vivo and in vitro studies demonstrating an approximately two-fold improvement in the ability of SYNB1934 to break down Phe compared to SYNB1618. The Phase 1 multiple ascending dose study of SYNB1934 evaluated the safety, tolerability and Phe consumption activity of SYNB1934, including a head-to-head comparison with SYNB1618 in healthy volunteers using biomarkers of Phe consumption such as trans-cinnamic acid, or TCA). Results included: dose dependent increase in plasma TCA area under the curve; two-fold higher activity level than SYNB1618 in a head-to-head comparison based on biomarkers of Phe consumption. Safety and tolerability in cohorts 1-3 were similar to other Synthetic Biotic medicines, including SYNB1618, at equivalent doses. The most common adverse events were GI-related, mild to moderate in severity, and some events led to discontinuation of dosing. Dosing continues in the dose escalation portion of the study and the maximum tolerated dose has not been reached. SYNB1934 clinical results were consistent with preclinical data and previously presented prospective biomarker driven modeling. The company believes that the increased activity of SYNB1934, relative to SYNB1618, could provide the opportunity to optimize the clinical profile based on individual patient needs. Synlogic intends to complete the SynPheny-1 study with a cohort of patients receiving SYNB1934 and anticipates final SynPheny-1 results in the first half of 2022. Based on the clinical data from the SYNB1618 and SYNB1934 programs available to date, the company intends to initiate planning for a pivotal Phase 3 study of the most promising strain. Synlogic continues to evaluate Synthetic Biotic medicines for other metabolic diseases such as Enteric Hyperoxaluria, including development of predictive efficacy models. Preclinical and Phase 1A data suggest SYNB8802 has the potential to consume clinically meaningful levels of dietary oxalate in patients with disease. The company is continuing to enroll Part B of the Phase 1 study of SYNB8802 and due to ongoing challenges presented by the COVID-19 pandemic, anticipates study data will be available in the first half of 2022. Synlogic continues to advance preclinical programs targeting additional inherited and acquired metabolic indications. The company expects to file an IND for an additional metabolic indication in 2022.

06:33 EDT Brown & Brown announces asset acquisition of AGIS Network - Brown & Brown and AGIS Network announced that Brown & Brown has acquired substantially all of the assets of AGIS. AGIS Network is an employee benefits enrollment firm with a focus on long-term care benefits options for large employer groups, governmental agencies and individual consumers across the nation. AGIS has developed technology solutions to allow individuals to review financial options for long-term care products more efficiently and complete the enrollment process. AGIS will continue to collaborate with brokers across the country and operate under the leadership of Kevin Sypniewski from offices in San Ramon, California.

06:32 EDT Thomas H. Lee to acquire automation business from Brooks Automation for $3B - Thomas H. Lee Partners announced a definitive agreement with Brooks Automation to acquire its Semiconductor Solutions Group business in a transaction valued at $3B. The transaction is expected to close in the first half of calendar year 2022 upon satisfaction of customary closing conditions and regulatory approvals. This agreement will fulfill Brooks' intention to separate its business into two independent companies, a highly innovative automation technology company with significant expertise in semiconductors and meaningful white space to expand into multi-market automation, and a pure play life sciences company, which will remain public and will adopt a new name prior to closing. The automation business, which will retain the Brooks Automation name, reported approximately $613M in revenue in the last twelve months ended June 30, 2021

06:27 EDT SmileDirectClub up 15% in pre-market trading at $7.71 per share - Shares of SmileDirectClub are up about 15% at $7.71 in pre-market trading following Friday's 11.7% advance. The stock is the highest trending ticker on WallStreetBets Reddit thread and is also in the top-10 on StockTwits in terms of message volume over the past 24 hours.

06:16 EDT Verastem jumps 27% to $3.50 per share after data on VS-6766 in ovarian cancer

06:07 EDT OraSure receives $205M procurement contract for InteliSwab - OraSure Technologies announced that the Defense Logistics Agency has awarded the Company a procurement contract for its InteliSwab COVID-19 Rapid Test for over-the-counter use, which the Defense Logistics Agency estimated to have a value of $205M. Under the terms of the contract, OraSure will provide its InteliSwab COVID-19 Rapid Test to up to 25,000 sites throughout the United States and the tests will be funded by the U.S. federal government. The contract will run from October 2021 through September 2022. InteliSwab is a simple "swab, swirl, see" test that uses an integrated swab to self-collect a sample from the lower nostrils. The result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed. It has three Emergency Use Authorizations from the Food and Drug Administration for professional point-of-care use, prescription home use, and over-the-counter use. As the Company ramps to meet the requirements in this contract, it anticipates having significant incremental manufacturing and operating expenses in the second half of fiscal year 2021. Additionally, given the volume ramp implied in the contract, the Company expects the preponderance of revenue associated with the contract to come in calendar year 2022.

06:04 EDT Amazon, Global Optimism announce 86 new signatories to The Climate Pledge - Amazon (AMZN) and Global Optimism announced that more than 200 companies have now signed The Climate Pledge. The 86 new signatories joining The Climate Pledge include Procter & Gamble (PG), HP (HPQ), Salesforce (CRM), ASOS (ASOMY), and Nespresso. Pledge signatories in total generate over $1.8 trillion in global annual revenues and have more than 7 million employees across 26 industries in 21 countries. By achieving net-zero carbon by 2040, 10 years ahead of the Paris Agreement, current Climate Pledge signatories are expected to collectively mitigate 1.98 billion metric tons of carbon emissions from a 2020 baseline. This is equivalent to 5.4% of current global annual emissions-demonstrating the collective impact The Climate Pledge is expected to have in addressing climate change and prompting more action to tackle the climate crisis. Signatories to The Climate Pledge agree to: Measure and report greenhouse gas emissions on a regular basis. Implement decarbonization strategies in line with the Paris Agreement through real business changes and innovations, including efficiency improvements, renewable energy, materials reductions, and other carbon emission elimination strategies. Neutralize any remaining emissions with additional, quantifiable, real, permanent, and socially beneficial offsets to achieve net-zero annual carbon emissions by 2040.

05:51 EDT Personalis announces Veterans Affairs task order for up to $10M - Personalis, announced that the U.S. Department of Veterans Affairs Million Veteran Program has issued a new task order under its current contract with the company, with a value of up to approximately $10M. The company also announced that it has received, so far in Q3, more than $25M in orders from its oncology customers, "a new record." Personalis said it has delivered over 140,000 whole human genomes to date, and "with this new task order remains on track to reach its goal of 150,000 by the end of 2021. "

05:26 EDT Carnival resumes sailings from port of New Orleans - Carnival Glory is set to depart on a seven-day cruise from the Port of New Orleans marking the first sailing from the city since the industry-wide pause in operations 18 months ago. Carnival Glory's voyage from the Erato Street Cruise Terminal includes visits to three popular Bahamian destinations: Bimini, Freeport and Nassau.

05:20 EDT Rio Tinto approves new solar farm, battery storage at Weipa in Queensland - Rio Tinto has approved a new solar farm and battery storage at Weipa in Queensland, in a move that will more than triple the local electricity network's solar generation capacity and help provide cleaner power to Rio Tinto's operations. Under the plans, EDL has been contracted to build, own and operate a 4MW solar plant and 4MW/4MWh of battery storage at Weipa. Work on the battery facilities will start this year, with construction of the whole project expected to be complete by late 2022. The new solar farm and battery storage will complement the existing 1.6MW solar farm at Weipa, which was completed in 2015 and is also owned and operated by EDL. The 4MWh battery system will be built next to the existing Weipa power station and will help provide a stable power network for Rio Tinto's Weipa Operations bauxite mines and the Weipa township.

05:14 EDT WISeKey signs two MoUs to develop 4IR Center of Excellence - WISeKey announced the signatures of two memoranda of understanding, or MoUs, with Fabian Picardo, Chief Minister of Gibraltar and the Mayor of La Linea de la Concepcion, Juan Franco, for the development of a joint 4th Industrial Revolution Center of Excellence. The business model of the joint 4IR Center of Excellence is to assist start-ups in areas such as AI, Blockchain, IoT, Satellite, IoT, Drones, Cybersecurity and Quantum to perform collective R&D activities, promote their technologies internationally, facilitate the adaptation and on-boarding of 4IR-based solutions, foster stronger collaboration between the public, private and academic sectors and cooperate to ensure that the latest technological standards are made available in a safe and trusted manner. The LLG 4IR Center of Excellence will initialize operations with the launch of WISeSAT Fossa Systems satellites at the end of the 2021 calendar year with an earth station located in La Linea. The objective of this pilot project is to enable the joint center to become a hub for IoT cybersecurity satellite deployment and communication under plans being advanced by WISeKey and Fossa Systems.

05:04 EDT Ceragon Networks secures multi-million-dollar contract from Indonesia government - Ceragon Networks announced that it has secured a multi-million-dollar contract to design and supply a microwave network in Indonesia as part of a government project to provide internet and telecom access to rural areas in the country, including schools, government offices, and hospitals. In this project, Ceragon is the primary vendor selected to provide the wireless transmission solutions for the 4G LTE access network, including design and project management services. With 16,056 islands, extreme humidity that ranges between 70%-90%, heavy rainfall, and climbing cases of COVID-19, the project poses a challenge for Indonesia in the achievement of its Universal Service Obligation goal.