Stockwinners Market Radar for November 11, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:51 EST Cathie Wood's ARK Investment bought 2.03M shares of 3D Systems on Thursday

20:01 EST Ballard Power acquires Arcola Energy for up to $40M - Ballard Power Systems announced the acquisition of Arcola Energy, a UK-based systems engineering company specializing in hydrogen fuel cell powertrain and vehicle systems integration. Ballard acquired 100% of Arcola for total upfront and earn-out cash and share consideration of up to $40M, based on the achievement of certain performance milestones.

18:23 EST AirBNB, DoorDash, Coinbase, Affirm Holdings among names added to U.S. MSCI - As part of its semiannual index review, MSCI has added Airbnb (ABNB), DoorDash (DASH), Coinbase (COIN), Affirm Holdings (AFRM), Robinhood (HOOD), Upstart (UPST), and UiPath (PATH), among other names. Full list of stocks added and deleted is available here: Reference Link

17:55 EST Adaptive Biotechnologies gets updated coverage for its MRD assay - The company states: "Adaptive Biotechnologies announced that Palmetto GBA's Molecular Diagnostics Program, or MolDX, has finalized a local coverage determination which supports the Medicare coverage for clonoSEQ to detect and monitor minimal residual disease in patients with B-cell acute lymphoblastic leukemia, multiple myeloma and chronic lymphocytic leukemia."

16:44 EST Fiesta Restaurant targets return to adjusted EBITDA margins in 18%-20% - CEO Richard Stockinger says: "In order to improve margins after the wage rate increases, we implemented a phased approach to price increases of 3.7% in mid-third quarter with approximately 4% to 6% planned for the fourth quarter along with accelerating our ongoing actions to optimize restaurant labor efficiency. Those actions have already resulted in Restaurant-level Adjusted EBITDA margin improvement, a non-GAAP financial measure, based on preliminary October 2021 results compared to the third quarter of 2021. Restaurant-level Adjusted EBITDA margins declined during the third quarter compared to 2020 primarily due to hourly wage rate increases, short-term hiring incentives, and additional overtime and training. A large portion of those increases are short term only, estimated at $0.9M, or approximately 100 basis points as a percentage of sales. Third quarter 2021 loss from continuing operations was $3.2M compared to income from continuing operations in the third quarter of 2020 of $4.4M. As we look toward the balance of the year, we are focused on continuing efforts to be a preferred employer and accelerating our margin improvement above the third quarter of 2021. We are targeting Restaurant-level Adjusted EBITDA margins returning to the 18% to 20% range in the first half of 2022, barring unforeseen changes in our cost structure and operating environment. In addition, we will continue enhancing the customer experience across all service channels, further investing in our growing digital platform, and refining our brand proposition and new unit design features in remodel tests to drive future growth."

16:31 EST Travel + Leisure raises quarterly dividend to 35c per share form 30c - The board of directors of Travel + Leisure Co. has declared a regular cash dividend on the company's common stock, increasing the quarterly dividend rate to 35c per share, up from 30c per share. The dividend is payable December 30, 2021 to shareholders of record as of December 15, 2021. On an annualized basis, the dividend increases to $1.40 cents per share, up nearly 17% from the previous annualized level of $1.20 per share. "The continued payment of a dividend throughout the pandemic demonstrated our confidence in the resiliency of this business and its ability to generate free cash flow," said Mike Hug, chief financial officer of Travel + Leisure Co. "The dividend increase announced today reflects the strategy we shared at our Investor Day in September to deploy additional free cash flow to increase the returns to our shareholders."

16:27 EST U.S. Steel permanently de-risks portion of its pension plan - United States Steel Corporation announced it has purchased group annuity contracts from Banner Life Insurance Company and William Penn Life Insurance Company of New York to transfer approximately $284M of the company's pension plan obligations to Legal & General. The purchase of the group annuity contracts will be funded directly by the assets of the pension plan. "Legal & General was carefully selected by an independent fiduciary as a highly rated and experienced retirement benefits provider to ensure our retirees' benefits are secured and maintained, a continued priority of our Best for AllSM strategy," said U. S. Steel President and Chief Executive Officer David B. Burritt. "This transaction is yet another meaningful step in strengthening the Company's balance sheet and further de-risking our pension plan, a plan that remains more than 100% funded and is an important source of differentiation versus some peers in the steel industry." The purchase results in the transfer of administrative and benefit-paying responsibilities for approximately 17,800 U.S. retirees and beneficiaries to Legal & General. Legal & General will begin paying benefits for certain retirees and beneficiaries in the United States Steel Corporation Plan for Employee Pension Benefits (Revision of 2003) on January 1, 2022. There will be no change to the pension benefits for any retirees and beneficiaries as a result of the transaction. Details will be provided to retirees and beneficiaries whose continuing payments will be fulfilled by Legal & General. As a result of the transaction, the company expects to recognize a non-cash pension settlement charge of approximately $110M, subject to finalization of actuarial assumptions and other applicable adjustments in the fourth quarter of 2021.

16:18 EST Ryan Specialty Group raises FY21 organic revenue growth view to 21.5%-22.5% - Prior forecast was 18%-20%. Raises FY21 EBITDAC margin view to 31.5%-32.0% from prior view of 30.0%-30.5%.

16:14 EST 89bio announces anticipated milestones - Report topline data from the open-label histology cohort in biopsy-confirmed fibrosis stage F2 - F3 NASH patients in early to mid-January 2022. Report topline data from the Phase 2 ENTRIGUE trial of BIO89-100 in severe hypertriglyceridemia patients in the first half of 2022. Present new analyses from the Phase 1b/2a NASH trial of BIO89-100 showing beneficial effects on spleen volume in an oral presentation at AASLD's The Liver Meeting 2021. Continue to enroll patients in the ENLIVEN Phase 2b trial of BIO89-100 for the treatment of NASH.

16:10 EST LiveVox affirms FY22 contract revenue growth of 25% - The company states: "For the full year 2022, while we are still not providing formal guidance, we do reaffirm a minimum year-over-year growth rate in Contract Revenue of 25% based on our recent bookings momentum."

16:09 EST Flowers Foods sees FY21 CapEx $125M-$135M

16:07 EST Guardant Health announces Guardant360 test helps guide cancer treatment - The company states: "Guardant Health announced that a study published in Nature Medicine reinforces the benefits of using the Guardant360(R) liquid biopsy test to help guide treatment decisions for patients with HER2-driven metastatic colorectal cancer. Led by the National Cancer Center Hospital East in Japan, the study demonstrates that the Guardant360 test can select patients for HER2-directed therapy, identify which patients are responding to treatment, as well as identify genetic alterations that predict resistance. The Phase 2 TRastuzumab combIned with pertuzUMab for Patients with Her2-positive mCRC study evaluated the efficacy of targeted therapy pertuzumab plus trastuzumab in patients with mCRC harboring HER2 amplification as detected by analysis of circulating tumor DNA or tissue genotyping. All patients were previously treated with monoclonal antibodies targeting EGFR. Additional exploratory analyses were conducted to evaluate the utility of ctDNA genotyping to predict treatment efficacy, monitor response, and identify the resistance mechanisms."

16:02 EST Spotify to acquire Findaway, terms not disclosed - Spotify "announced it has entered into a definitive agreement to acquire Findaway, a global leader in digital audiobook distribution. Terms of the transaction were not disclosed. The company will maintain its headquarters in Solon, Ohio and will continue to be led by Findaway Founder & CEO Mitch Kroll, who will report to Nir Zicherman, Head of Audiobooks at Spotify. The transaction is expected to close in the fourth quarter of 2021 and is subject to regulatory review and approval."

15:37 EST Albertsons announces launch of retail media network - Albertsons Companies announced the launch of Albertsons Media Collective, which it calls "a retail media network designed to deliver digitally native, shopper-centric and engaging branded content to the company's ever-growing network of shoppers." The company added: "With retail media networks rapidly reshaping the advertising space across the consumer media sector, Albertsons Media Collective, led by Kristi Argyilan, Albertsons Cos.' SVP of Retail Media, will offer partners a digital marketing platform and omnichannel solutions with the core consumer in mind." Brand campaigns will begin February 27, 2022, and "allow partners to access some of the most valuable positions across Albertsons Companies' websites and apps," the company added.

14:37 EST Ocugen says COVAXIN showed 77.8% overall efficacy against COVID-19 in study

14:35 EST DoorDash, Payfare launch instant pay nationwide - Last night, DoorDash (DASH) and Payfare (PYFRF) announced instant access to earnings for DoorDash delivery drivers across the United States via DasherDirect. DasherDirect is a financial platform and digital banking solution for Dashers, powered by Payfare. Through DasherDirect, Dashers gain access to automatic, no-fee payouts after every dash, in direct response to Dasher feedback requesting faster access to their earnings. According to the companies, DasherDirect offers Dashers a Business Prepaid Visa Card and mobile banking app along with free digital banking and exclusive rewards, including 2% cash back on every gas purchase. "With no credit check or prior bank account required to sign up, DasherDirect offers Dashers access to quality, secure digital banking on the go, including free withdrawals at more than 20,000 ATMs nationwide. DasherDirect also offers free fund transfers with no minimums, the ability to set savings goals and now earnings available in their DasherDirect account within minutes after every dash," the companies added. The DasherDirect app is available for iOS and Android mobile users on the Apple App Store and Google Play Store. The DasherDirect Business Prepaid Visa Card is issued by Stride Bank, member FDIC, pursuant to a license from Visa U.S.A.

14:28 EST Penn National up after Portnoy tweet on 'exposing Business Insider hit piece' - Shares of Penn National are higher in afternoon trading after Barstool founder Dave Portnoy tweeted about how he was going to "expose" Business Insider's "hit piece" along with a link to a broadcast he was hosting. Previously, on November 4, shares of Penn National Gaming fell after Business Insider reported on sexual assault allegations against Portnoy. In Thursday afternoon trading, Penn National shares are up 4%. Reference Link

14:05 EST Amazon to let users share clips from Prime Video shows on iOS phones - Amazon (AMZN) said that users can you send scenes from various Amazon Original series straight from their iOS (AAPL) phones. "With X-Ray technology, Prime Video customers can now share their favorite clips from select Amazon Original series with friends and family on social media, or via direct message," the company said in a blog post. "From the first scene in Season One of The Boys, to the first time Toni and Shelby meet in The Wilds, to that jaw-dropping reveal at the end of Invincible Episode One, and the many adventures of Dale, Derica, Benny, and Truman in Fairfax, there are plenty of snackable scenes to share." This feature will be available for The Boys, The Wilds, Invincible, and Fairfax, with more Amazon Original movies and series to follow. Reference Link

13:34 EST Zynga acquires mobile game studios ByteTyper, Creasaur Entertainment and ZeroSum - Rollic, a subsidiary of Zynga, announced that it has recently closed the acquisitions of three Turkey-based mobile game studios: ByteTyper, Creasaur Entertainment and ZeroSum. "All three studios have previously published games with Rollic and will continue to develop original mobile titles in-house under the Rollic umbrella," Zynga said. The trio of "hit-making mobile game developers add to Rollic's fast-paced growth," said Zynga, which added that Rollic has surpassed 1 billion total downloads worldwide with three of its titles surpassing 100 million downloads each and 16 of its titles reaching the #1 or #2 top free downloaded game positions in the U.S. App Store to date. Reference Link

13:02 EST Moderna disagrees NIAID scientists co-invented mRNA sequence claims - In a statement, Moderna said: "Moderna has recognized the substantial role that the NIAID has played in helping to develop Moderna's COVID-19 vaccine by including NIAID scientists as co-inventors on published patent applications where they have made inventive contributions. Under U.S. patent law, there are strict rules for determining who should be listed as inventors on a patent. Just because someone is an inventor on one patent application relating to our COVID-19 vaccine does not mean they are an inventor on every patent application relating to the vaccine. We do not agree that NIAID scientists co-invented claims to the mRNA sequence of our COVID-19 vaccine. The mRNA sequence was selected exclusively by Moderna scientists using Moderna's technology and without input of NIAID scientists, who were not even aware of the mRNA sequence until after the patent application had already been filed. Therefore, only our scientists can be listed as the inventors on these claims. This conclusion is supported NIAID's own patent filings, specifically a separate patent application filed on February 11, 2020 with the University of Texas where NIAID scientists claim to have invented similar subject matter. As a legal and practical matter, the same thing cannot be claimed to be invented twice by the same people working with two different collaborators. For those who would seek to twist Moderna's good faith application of U.S. patent law, nothing could be further from the truth. Moderna remains the only company to have pledged not to enforce its COVID-19 intellectual property during the pandemic . Moreover, on September 29th, Moderna offered to resolve its dispute with NIAID by making the government co-owners of those patent applications that only listed Moderna scientists as inventors, including the right as co-owners to license the patents as they see fit. Moderna is grateful for our collaboration with NIH scientists, and highly value their contributions. We remain focused on working together with our collaborators to address the pandemic."

12:52 EST Robinhood says all systems operational following login issue - According to Robinhood's status webpage, all systems are operational following a reported login issue for customers. Reference Link

12:39 EST MDU Resources raised quarterly dividend to 21.75c from 21.25c - MDU Resources Group said its board increased the company's quarterly common stock dividend to 21.75c per share, for an annualized dividend of 87c per share. The previous quarterly dividend was 21.25c per share. The quarterly dividend is payable January 1, 2022, to stockholders of record December 9, 2021. "We remain committed to paying dividends to our shareholders as part of the total value they receive from their investment in MDU Resources," said Dennis Johnson, chair of the board. "We also are proud of our long tradition of annually increasing those dividends."

12:01 EST Oscar Health falls -23.5% - Oscar Health is down -23.5%, or -$3.88 to $12.64.

12:01 EST Paysafe falls -40.2% - Paysafe is down -40.2%, or -$2.92 to $4.35.

12:00 EST Fisker rises 15.7% - Fisker is up 15.7%, or $2.96 to $21.85.

11:55 EST Medicare expands coverage of Natera's Signatera beyond initial indication - Natera announced that the CMS Molecular Diagnostics Services Program has issued a final local coverage determination for pan-cancer immunotherapy monitoring using its Signatera molecular residual disease test. An accompanying Billing and Coding Article specifies that serial testing with Signatera is now covered for Medicare patients being treated with immunotherapy, regardless of tumor type, the company said in a statement. The final LCD is consistent with the draft posted in September 2020, also establishing an accelerated pathway to Signatera coverage in new testing indications.

11:32 EST Cortexyme to present additional data from Phase 2/3 GAIN trial - Cortexyme will present additional data from its Phase 2/3 GAIN Trial at the 14th Clinical Trials on Alzheimer's Disease Conference as a part of the meeting's Late-Breaking Readout Roundtable program. The presentation will expand on previously reported top-line results that demonstrated the relationship between the reduction of Porphyromonas gingivalis infection and the slowing of cognitive decline in Alzheimer's disease with atuzaginstat treatment in a prespecified population of patients based on diagnosis of infection. The 643-participant 48-week GAIN Trial was the first large study to test the efficacy of an oral small-molecule targeting P. gingivalis for disease modification in mild to moderate Alzheimer's patients. While not meeting statistical significance on its co-primary cognitive and functional endpoints in the overall cohort, the study data showed that treatment with atuzaginstat slowed decline compared to placebo on the majority of clinical endpoints in prespecified populations that were selected based on P. gingivalis infection markers. The GAIN Trial results showed that the 40 mg BID arm demonstrated equivalent or better efficacy across key endpoints compared to the higher dose, 80 mg BID, as well as a superior safety profile. Trends to benefit at 40 mg BID were seen with multiple prespecified analytic approaches, including on ADAS-Cog11, CDR-SB, MMSE, and NPI, with increasing separation from placebo throughout the study consistent with disease modification. Benefits were not seen on ADCS-ADL at either dose. Changes in P. gingivalis DNA levels in saliva correlated significantly with clinical outcomes during and at the end of treatment, demonstrating that reduced P. gingivalis bacterial load resulted in better clinical outcomes. A trend to slowing of the primary biomarker endpoint of hippocampal atrophy was seen in treatment groups, but did not reach significance. Across critical safety measures, the rates in the 40 mg BID treatment arm were either comparable to placebo or substantially better than in the 80 mg BID arm. Most adverse events were mild to moderate in severity. The most common were gastrointestinal, such as diarrhea in up to 16% and nausea in 6% of participants treated with atuzaginstat, versus 3% and 2% of placebo participants, respectively. Atuzaginstat was associated with dose-related liver enzyme elevations greater than3X the upper limit of normal: 2% on placebo, 7% on 40 mg BID, and 15% on 80 mg BID. These elevations alone were not clinically significant and virtually all participants were asymptomatic. Two participants in the 80 mg BID arm had concomitant bilirubin elevations without alternative explanation. Lab changes resolved while participants remained on drug or after withdrawal without any known long-term adverse effects. Atuzaginstat treated groups showed no increase in ARIA, including microhemorrhage and edema, or superficial siderosis.

11:11 EST NuZee says Cuvee Coffee expands into select Walmart stores nationwide - Specialty coffee roaster Cuvee Coffee announced its expansion into over 3,000 Walmart (WMT) stores nationwide. "Starting November 8, customers will have the opportunity to shop Cuvee Coffee's single serve filter bags produced by its partner manufacturer, NuZee, Inc., a leading co-packing company for single serve coffee formats," the company announced in a press release. "NuZee is thrilled to see our partner roasters, Cuvee Coffee, expand their customer reach with the single serve filter bags at select Walmart locations nationwide. This partnership is offering a new way for coffee-lovers to easily access this high quality and convenient format, that is ideal for those on the go to enjoy life's adventures,'' said Travis Gorney, Chief Innovation Officer at NuZee (NUZE).

11:06 EST Regeneron: CHMP recommends EU approval of antibody cocktail to treat Covid - Regeneron Pharmaceuticals (REGN) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the casirivimab and imdevimab antibody cocktail, known as REGEN-COV in the U.S. and Ronapreve in the European Union and other countries. The positive opinion is for people aged 12 years and older for the treatment of non-hospitalized patients with confirmed COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19, and to prevent COVID-19. A final decision from the European Commission regarding the approval of the antibody cocktail is expected in the near future.The positive opinion is based on two positive Phase 3 trials involving more than 6,000 individuals that evaluated the efficacy and safety of the antibody cocktail to treat non-hospitalized patients already infected with SARS-CoV-2, and to prevent symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals. Regeneron invented the antibody cocktail and is collaborating with Roche (RHHBY), who is primarily responsible for development and distribution outside the U.S. In addition to this Marketing Authorization Application, the companies intend to submit a future Type II Variation to the EMA that seeks to expand the potential indication to include the treatment of patients hospitalized because of COVID-19. In October, the U.S. FDA accepted for priority review the first of two Biologics License Applications for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The second BLA submission will focus on those hospitalized because of COVID-19 and is expected to be completed later this year.

10:56 EST Novo Nordisk says Wegovy recommended in Europe for obesity - Novo Nordisk announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending marketing authorization for Wegovy for chronic weight management in adults with obesity. Wegovy is a once-weekly semaglutide injection for chronic weight management in adults living with obesity or overweight with at least one weight-related comorbidity such as high blood pressure, heart disease or type 2 diabetes. "With the unprecedented and sustained weight loss for an anti-obesity medication, Wegovy has the potential to transform obesity management and help millions of people living with obesity," said Martin Holst Lange, executive vice president, Development at Novo Nordisk. "We are looking forward to driving change for people with obesity by introducing Wegovy in Europe next year." Novo Nordisk expects to receive final marketing authorization from the European Commission in approximately two months. Wegovy was launched in the U.S. in June.

10:22 EST Gaucho Group makes additional $3.5M investment for Las Vegas project - Gaucho Group Holdings announced it has made a new $3.5M payment to LVH Holdings LLC to further advance the previously announced agreement to develop a project in Las Vegas, Nevada. Gaucho Holdings' new payment of $3.5M toward the project, brings its commitment thus far to $7M paid toward what is expected to be a total commitment of $35M for a 40% ownership of the project. The company said, "Gaucho Holdings believes the Las Vegas project can expand the Gaucho brand in ways that could include opportunities in lodging, hospitality, retail, and gaming."

10:14 EST European Medicines Agency recommends Roche, Regeneron Covid anitbody - The European Medicines Agency's human medicines committee recommended authorizing Ronapreve for treating Covid-19 in adults and adolescents. Ronapreve can also be used for preventing Covid-19 in people aged 12 years and older weighing at least 40 kilograms. The company that applied for authorization of Ronapreve was Roche (RHHBY), in conjunction with Regeneron (REGN). With regard to Regkirona, the committee recommended authorizing the medicine for treating adults with Covid-19 who do not require supplemental oxygen and who are also at increased risk of their disease becoming severe. The applicant for Regkirona was Celltrion Healthcare. The CHMP will now send its recommendations for both medicines to the European Commission for "rapid legally binding decisions." Ronapreve and Regkirona are the first monoclonal antibody medicines to receive a positive opinion from the CHMP for Covid-19. Reference Link

10:03 EST IAA joins Department of Defense Military Spouse Employment Partnership - IAA announces that it has joined the Department of Defense Military Spouse Employment Partnership. In late October, IAA attended a virtual ceremony to be inducted along with 45 other new partners to MSEP, bringing the number of employers to 544. MSEP connects military spouses with hundreds of partner employers who commit to recruit, hire, promote and retain military spouses. Since its inception in 2011, MSEP employers have hired more than 200,000 military spouses.

10:01 EST Bright Health falls -20.5% - Bright Health is down -20.5%, or -$1.50 to $5.80.

10:00 EST DHI Group rises 11.1% - DHI Group is up 11.1%, or 55c to $5.49.

10:00 EST Beazer Homes rises 15.6% - Beazer Homes is up 15.6%, or $2.93 to $21.72.

09:47 EST Blend Labs falls -15.2% - Blend Labs is down -15.2%, or -$2.35 to $13.10.

09:47 EST Paysafe falls -32.4% - Paysafe is down -32.4%, or -$2.35 to $4.92.

09:47 EST Beazer Homes rises 14.3% - Beazer Homes is up 14.3%, or $2.68 to $21.47.

09:41 EST Alibaba lists Apple, L'Oreal among those over RMB100M in GMV in 11.11 lead-up - "Consumer tech company Apple and beauty retailer L'Oreal topped RMB100M, or $15.6M, in sales between midnight on November 1 and 00:45 on November 11," Alibaba Group reported in a 11.11 festival live blog. "They are among 382 brands that saw their gross merchandise value - GMV - surpass RMB100 million in the 10 days before 11.11," Alibaba said. "40 brands which recorded more than RMB10 million in GMV during last year's 11.11 have already surpassed RMB100 million in GMV this year, with almost a full day to go before the event officially ends," Alibaba added in its blog post. Reference Link

09:37 EST GH Research PLC trading resumes

09:32 EST GH Research PLC trading halted, volatility trading pause

09:20 EST USMC advanced reconnaissance vehicle prototypes feature Allison Transmission - Allison Transmission is an active participant in the U.S. Marine Corps' combat vehicle modernization plan. Both Textron Systems and General Dynamics Land Systems have been down-selected by the Marine Corps to build prototypes for the Advanced Reconnaissance Vehicle, ARV, competition and both are equipped with an Allison Specialty Series transmission as their propulsion solution. The Marine Corps also announced it will work with BAE Systems to study the possibility of adapting their Amphibious Combat Vehicle, ACV, to become the ARV. BAE's ACV, which entered full rate production in February 2021, uses an Allison 4000 Specialty Series transmission. "Allison takes great pride collaborating with leading defense partners, providing propulsion solutions for their vehicles, and meeting the requirements of the U.S military and our customers around the world," said Dana Pittard, Vice President for Defense Programs at Allison Transmission.

09:16 EST Surna signs preventative maintenance contracts for HVACD systems - Surna was awarded preventative maintenance contracts for HVACD systems from facilities in Arizona and Michigan. These facilities operate a combined 75,000 square feet of cultivation space.

09:12 EST Mondelez invests in CCOF to help efforts in plastic waste collection, recycling - Mondelez International has joined Circulate Capital Ocean Fund, CCOF, as a limited partner and making an investment in CCOF supporting scalable business solutions to help develop infrastructure for the collecting, sorting and recycling of plastic waste, including flexible films. The goal of this investment, which is part of Mondelez International's Sustainable Futures impact investing platform, is to enhance focus on the physical collection of flexible films - lightweight, multi-layer plastics used by the snacking industry - that have traditionally been more difficult to collect, sort, recycle and ultimately reuse. CCOF is an investment fund dedicated to addressing India and Southeast Asia's plastics challenges. "This investment marks a pivotal step forward in our contribution to a circular economy for plastics and is a clear demonstration of our long-term goal of net zero waste," said Dirk Van de Put, Chairman and Chief Executive Officer, Mondelez International. "As part of our ambition to become a more sustainable snacking company, this partnership will help fund businesses that are trying to fill systemic gaps in the collection, sorting and reuse of plastic waste, including flexible film."

09:11 EST Smartsheet, McLaren Racing in new partnership for McLaren Formula 1 team - McLaren Racing and Smartsheet announced a new partnership that will see Smartsheet become an official technology partner of the McLaren Formula 1 team at the 2021 Brazilian Grand Prix. "Smartsheet technology will be integrated into the McLaren Racing infrastructure to help drive the team's digital transformation, with an initial focus on smarter asset management to support fan engagement and race operations through Smartsheet's digital asset management platform, Brandfolder. The Smartsheet brand will first be represented on the McLaren MCL35M race cars at the 2021 Brazilian Grand Prix, and then on the race cars, pit-crew overalls, pit-wall stand and race suits of the McLaren F1 drivers, Lando Norris and Daniel Ricciardo, for the 2022 season and beyond," said the company in a stsatement.

09:09 EST My Size's MySizeID solution selected by Nautica Lifestyle Brand in Turkey - MySize announced a deal to offer its MySizeID application for global lifestyle brand Nautica in Turkey through the Eren Group, the licensed production owner of Nautica Turkey. The MySizeID app will be made available to Nautica customers in Turkey through their online retail e-commerce site.

09:08 EST California Resources tightens FY21 FCF view to $460M-$510M from $400M-$500M - CRC tightened its full year 2021 free cash flow1 guidance to $460 to $510 million from $400 to $500 million, raised its adjusted EBITDAX1 guidance to $840 to $900 million from $725 to $825 million and raised its production guidance to 99 to 101 MBOE per day from 97 to 100 MBOE per day. Rising natural gas prices are putting upward pressure on operating costs and CRC increased operating guidance to a range of $700 to $720 million for the year, up from $670 to $695 million. Although higher natural gas and electricity prices in 2021 increased CRC's operating costs, higher prices have a net positive effect on its operating results due to higher revenue from sales of these commodities which CRC also produces.

09:07 EST Adaptimmune says SPEARHEAD-1 trial will meet primary endpoint in final analysis - Adaptimmune Therapeutics will report updated clinical and translational data from its pivotal SPEARHEAD-1 trial with afamitresgene autoleucel in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma at the Connective Tissue Oncology Society annual meeting. Clinical data will be presented in an oral presentation by Dr. Brian Van Tine of the Washington University School of Medicine in St. Louis during the Immunotherapy & Immune Microenvironment Session starting at 10:00 a.m. EST on November 12th. Preliminary translational insights from the Phase 2 SPEARHEAD-1 trial will also be presented in a posted by Dr. Sandra P. D'Angelo of Memorial Sloan Kettering Cancer Center during the Immunology & Immunotherapy Session beginning at 2:30 p.m. EST on November 12th. Efficacy data validate the meaningful clinical benefit of afami-cel: 50 patients had received afami-cel; Median age of patients was 41 years and they had received a median of three prior lines of therapy. The median dose was 8.5 billion transduced SPEAR T-cells. Three patients had scans awaiting Independent Review and 47 patients were evaluable. The primary endpoint for SPEARHEAD-1 is response according to RECIST v1.1 evaluated by Independent Review. Based on the reported overall response rate, the trial will meet its primary endpoint in the final analysis planned later this year. Per Independent Review, the overall response rate was 34%. The overall response rate was 36% in patients with synovial sarcoma, and 25% for patients with MRCLS. The disease control rate was 85% per Independent Review. The overall response rate and disease control rate per Independent Review were comparable to the assessments by Investigator Review. Durability is encouraging and the median duration of response has not been reached. 75% of patients with response remain ongoing and the duration ranged from 4.3+ to 65.3+ weeks. Afami-cel was well-tolerated and has a favorable benefit:risk profile as of data cut-off. Thirty-three patients experienced adverse events of cytokine release syndrome, most of which were lower grade: Grade 1 or 2; Grade 3. The most common serious adverse event of any grade was CRS reported in 6% of patients; Eight patients experienced greater than or equal to Grade 3 cytopenia at Week 4. Afami-cel SPEAR T-cells successfully engrafted in all patients and maintained high levels of persistence in most patients followed for at least 6 months post-infusion. CD8+ SPEAR T-cells in drug products administered killed greater than70% tumor cells in vitro. Serum cytokine response profile indicates an IFNgamma-driven mechanism of action, signaling an afami-cel induced immune response. Clinical benefit seen across a broad range of MAGE-A4 expression. Post-infusion biopsies indicated that infiltrating afami-cel SPEAR T-cells co-localize with tumor and additional immune cells, with evidence of activated and proliferative state and adaptive-immune response. The trial will meet its primary endpoint for efficacy for this pivotal trial. As of September 1, 2021, overall response rate was 34% with a disease control rate of 85% per Independent Review in 47 heavily pre-treated patients. Durability of responses is encouraging, and the median duration of response has not been reached. The benefit:risk profile of afami-cel has been favorable, with mainly low-grade CRS and tolerable/reversible hematologic toxicities. Translational data confirm that afami-cel is active against MAGE-A4 expressing targets both in vitro and in vivo. These data will be used to support Adaptimmune's Biologics License Application submission next year.

09:06 EST Euroseas announces agreement to acquire 6,350 teu container vessel for $40M - Euroseas announced that it has agreed to acquire M/V Leo Paramount, a 6,350 teu container vessel built in 2005, for $40M. The vessel, which is expected to be delivered to the company within 2021 and be renamed M/V Marcos V, will be financed by own funds and a bank loan. Contemporaneously with the acquisition, the vessel will enter into a three-year time charter contract at a daily rate of $42,200 with a possible extension for an additional year at the option of the charterer at $15,000 per day. Aristides Pittas, Chairman and CEO of Euroseas commented: "We are pleased to announce the acquisition of M/V Leo Paramount, an intermediate containership, built in 2005. This acquisition continues our strategy of carefully constructed transactions minimizing the market risk by reducing, by the end of the charter, the cost basis to around its scrap value. The charter contract we have entered into with a first class charterer is expected to contribute about $35 million of EBITDA during the first three years of the contract providing us with a significant return on our investment. Furthermore, depending on the market after the end of the charter in three or four years we may have significant additional upside. With a fleet of sixteen feeder and intermediate containerships on the water, after the delivery of the above vessel, and two modern feeder newbuildings expected to be delivered in the first half of 2023, Euroseas reinforces its position as the main US publicly listed company focusing on feeder and intermediate container vessels. We believe, our growing presence in the sector and the public markets provides with a solid platform to consolidate in it other vessels or fleets."

09:03 EST Cadre initiates quarterly cash dividend at 8c per share - Cadre Holdings has declared a quarterly cash dividend of 8c per share, or 32c per share on an annualized basis. Cadre's first dividend payment will be made on December 7 to shareholders of record as of the close of business on the record date of November 22.

08:58 EST American Resources begins activity at reopened McCoy Elkhorn complex - American Resources announced that it has begun selling and shipping metallurgical carbon produced from its recently reopened Carnegie 1 mine. Shipments of carbon are being sold to its customer base to be used for steel making in both the international and domestic steel markets. Located in Pike County, Kentucky, the Company's Carnegie 1 mine is an underground mine producing high vol metallurgical carbon from the Lower Alma seam and part of both the Company's broader Carnegie mining complex and its McCoy Elkhorn processing and logistics facility. Carbon extracted from the Carnegie mines is transported to the nearby McCoy Elkhorn complex where it is processed, loaded and shipped to domestic and international metallurgical customers. Mark Jensen, CEO of American Resources Corporation commented, "It's always a rewarding day for our team when we see our efforts bear fruit by getting our first Carnegie mine reopened, as well as our McCoy Elkhorn facility, up and running and now shipping carbon to our steel customers. We are in a very fortunate spot to be expanding production of high-quality, steel-making carbon in a market that is seeing constrained supply struggling to meet worldwide infrastructure demands. The changes our team has made at this complex are focused on safety, cost and efficiency. While the Carnegie 1 mine was in production briefly before the COVID-19 pandemic hit our region, the mine is essentially new, allowing us to efficiently produce a quality product with decades of mine life. Our Carnegie 2 mine will subsequently be brought online in short order as we have already invested the development capital and have secured the contract mining company to operate this new mine which will access the same boundary of carbon from a different direction as our Carnegie 1 mine." In addition to its Carnegie 1 and Carnegie 2 mines, the Company has plans to develop it Carnegie 3 mine and its Carnegie Surface mine to supplement the complex's overall production at the facility. The Company is also evaluating upgrading the McCoy Elkhorn processing plant to produce a mini stoker industrial product for the specialty alloy metal marketplace given that market's consistently strong demand.

08:52 EST SG Blocks executes purchase agreement for mixed-use property in Oklahoma - SG Blocks announced that the company, on behalf of its development subsidiary, SGB Development, has executed a purchase agreement for a mixed-use property in Durant, Oklahoma with approximately 4,063,276 of square footage. This transaction is anticipated to close within the next sixty to ninety days. The purchase agreement contract is between the Durant Industrial Authority and SG Blocks, Inc.

08:44 EST Comtech files definitive proxy materials and mails letter to stockholders - Comtech Telecommunications announced that it has filed definitive proxy materials with the Securities and Exchange Commission in connection with its upcoming Fiscal 2021 Annual Meeting of Stockholders. In conjunction with the definitive proxy filing, Comtech is mailing a letter to stockholders "highlighting the meaningful steps the Company has taken, and continues to take, to enhance corporate governance, strengthen financial performance and flexibility, and create significant near- and long-term value for all stockholders. The full text of the letter follows: Your Board and management team have taken decisive action over the past several years to create long-term stockholder value and address stockholders' feedback. We have made significant progress in advancing our strategic plan - designing and delivering innovative communication solutions, investing in growth, and strengthening our portfolio by acquiring and integrating complementary technologies and capabilities. Today, we seek your support in voting FOR your Board's highly qualified nominees using the enclosed blue proxy card. Our strategic plan has enhanced our position as a secure wireless technology leader and already delivered strong results for stockholders, including: Leading market positions in attractive segments poised to benefit from secular growth. Since FY 2015, we have been executing a deliberate strategy to balance and enhance our best-in-class satellite communications business with attractive next-generation 911 public safety services capabilities. Our purpose-built organization now boasts industry-leading positions across two large and attractive markets where we provide critical, advanced communication and location solutions to a broad set of blue chip customers. During fiscal year 2021, we were recognized by Frost & Sullivan and Northern Sky Research for both our next-generation 911 solutions and our market leadership position in the growing satellite cellular backhaul market. Significant cross-segment business wins that position Comtech for growth," said the company in a statement.

08:42 EST Osisko Development announces drilling results from San Antonio Gold project - Osisko Development is pleased to announce drilling results from the 2021 exploration and category conversion drill program campaign at its San Antonio Gold Project in Sonora State, Mexico. The San Antonio Gold Project is an iron oxide copper gold style deposit with zones of oxide, transition, and sulphides on three main target areas: Sapuchi, Golfo de Oro and California. A total of 27,000 meters consisting of 156 holes have been drilled thus far in 2021. The objective of the drill program is to conduct exploration and resource drilling at a spacing of 25 meters and historic drilling validation for the three main target areas. The first 41 holes from the Sapuchi target are presented in this news release and include SP-DD-21-001 to SP-DD-21-060 inclusive. The Sapuchi gold mineralization is characterized by hydrothermal breccia that forms an approximately 3,000 m long east-northeast trending mineralization corridor with intense sericite and chlorite alteration in the mineralized zone. The mineralization is intrusion related within host sedimentary rocks. DD-21-038 intersected 21.65 meters of oxide assaying 2.14 g/t Au, extending the oxide an additional 15 meters at depth. DD-21-019 intersected 1.02 g/t Au over 39.90 meters in a newly discovered sulphide zone at 167.4 meters depth indicating significant exploration potential. Sapuchi target has a strike length of 700 meters and is open in all directions. Assay Highlights: 2.16 g/t Au and 2.90 g/t Ag over 12.50 meters in hole SP-DD-21-001 including 11.45 g/t Au and 13.80 g/t Ag over 1.10 meters; 2.37 g/t Au and 2.02 g/t Ag over 10.25 meters in hole SP-DD-21-006; 1.01 g/t Au and 11.75 g/t Ag over 17.70 meters in hole SP-DD-21-006; 1.50 g/t Au and 3.06 g/t Ag over 13.85 meters in hole SP-DD-21-007; 1.58 g/t Au and 32.51 g/t Ag over 9.45 meters in hole SP-DD-21-007; 1.08 g/t Au and 2.69 g/t Ag over 20.45 meters in hole SP-DD-21-008; 1.59 g/t Au and 3.68 g/t Ag over 22.15 meters in hole SP-DD-21-008; 2.94 g/t Au and 3.98 g/t Ag over 12.65 meters in hole SP-DD-21-008 including 44.40 g/t Au and 54.40 g/t Ag over 0.70 meter; 2.24 g/t Au and 14.32 g/t Ag over 9.00 meters in hole SP-DD-21-010; 0.72 g/t Au and 4.13 g/t Ag over 20.85 meters in hole SP-DD-21-011; 1.02 g/t Au and 3.90 g/t Ag over 39.90 meters in hole SP-DD-21-019; 1.60 g/t Au and 3.09 g/t Ag over 19.30 meters in hole SP-DD-21-029; 1.30 g/t Au and 3.06 g/t Ag over 22.00 meters in hole SP-DD-21-034; 2.14 g/t Au and 3.05 g/t Ag over 21.65 meters in hole SP-DD-21-038; 1.52 g/t Au and 13.77 g/t Ag over 29.20 meters in hole SP-DD-21-040; 1.80 g/t Au and 1.19 g/t Ag over 11.85 meters in hole SP-DD-21-047; 2.19 g/t Au and 5.35 g/t Ag over 9.10 meters in hole SP-DD-21-060 The San Antonio Gold Project gold mineralization is characterized by hydrothermal breccia that forms an approximately 3,000 meters long east-northeast trending mineralization corridor with the Luz del Cobre copper deposit at the east. The gold mineralization is associated with intense sericite and chlorite alteration and is intrusion related with host sedimentary rocks. The breccia has been defined to a vertical depth of 500 meters and at an average depth of 250 meters. The upper 250 meters of the breccia is mostly altered and prospective. Drilling has occurred within the three major zones at Sapuchi, Golfo de Oro and California, over a combined strike length of 900 meters of the 3000-meter trend. True widths are estimated to be 80% to 100% of reported core length intervals. Intervals not recovered by drilling were assigned zero grade. Top cuts have not been applied to high grade assays.

08:39 EST SharpLink Gaming resechedules corporate update webcast to December 15 - SharpLink Gaming announced that its Corporate Update Webcast, originally scheduled to occur on Wednesday, November 17, 2021 beginning at 11:30 AM ET, has been rescheduled to Wednesday, December 15, 2021 beginning at 11:30 AM ET. The rescheduling of the event to be hosted by SharpLink CEO Rob Phythian and key members of the Company's leadership is due to an unanticipated scheduling conflict. Investors and analysts are encouraged to submit questions they would like management to address on the December 15 webcast no later than Friday, December 10, 2021 at 5:00 PM ET.

08:38 EST CAE sees FY22 CapEx exceeding C$250M - Total capital expenditures are expected to exceed C$250M in fiscal year 2022, primarily in support of sustainable and accretive growth opportunities. The company usually sees a higher investment in non-cash working capital accounts in the first half of the fiscal year, and as in previous years, management expects a portion of the non-cash working capital investment to reverse in the second half. The company continues to target a 100% conversion of net income to free cash flow for the year. In addition to restructuring, integration and acquisition costs related to the L3H MT acquisition in Defence, CAE expects to incur total restructuring expenses related to its ongoing cost saving initiatives of approximately C$50M in fiscal year 2022. The company continues to expect to reach a run-rate annual recurring cost savings of approximately C$65M-C$70M by the start of fiscal year 2023.

08:37 EST Quoin Pharmaceuticals, Genpharm Services sign exclusive license deal for QRX003 - Quoin Pharmaceuticals announced that they have entered into an exclusive License and Distribution Agreement for QRX003, Quoin's investigational treatment for Netherton Syndrome, a rare and devastating genetic disease. Under the terms of the agreement, Genpharm Services has exclusive rights to commercialize QRX003 in the Middle East and North Africa region, upon the receipt of regulatory approvals in both territories. Upon approval and launch of the product, Quoin will be entitled to a revenue sharing arrangement on net sales of the product. The companies have also entered into an exclusive Supply Agreement, under which Quoin is obligated to manufacture and supply the product to Genpharm Services. Dr. Michael Myers, Chief Executive Officer of Quoin, commented, "The licensing agreement with Genpharm is the second licensing agreement that we've announced for QRX003, which we are developing as a potential treatment for Netherton Syndrome. Genpharm's focus on commercializing drugs for rare and orphan diseases in all of the key Middle East and North African pharmaceutical markets makes them an ideal partner for Quoin."

08:35 EST AGM Group Holdings to establish manufacturing base in North America - AGM Group Holdings is exploring strategic opportunities to set up its North American manufacturing operations in the United States or Canada to strengthen the company's position in the Bitcoin mining sector. Pittsburgh and Seattle are among cities the company is considering for this manufacturing base, which is potentially expected to accommodate AGMH's R&D lab, hardware production, assembly lines, and business development team. As a first step in reaching into the North American industry network, AGMH has sent some sample components of mining machines to local manufacturers for production tests and manufacturing base selection.

08:34 EST Greenlight Capital Re announces investment in Blueprint Holding - Greenlight Re Innovations, part of Greenlight Capital Re, has announced an investment in Blueprint Holding. The title insurance market has historically experienced outsized expense ratios driven by agency commissions. Blueprint reduces these costs by centralizing underwriting and agency operations under a full-stack carrier, significantly reducing the expenses per file. Simon Burton, Chief Executive Officer at Greenlight Re, said, "Title insurance is the perfect example of an inefficient marketplace with high expense ratios. The title market is well-suited to innovative solutions, and we are pleased to partner with Blueprint as they look to transform this market through innovative technology, automated processes, and competitive pricing."

08:33 EST Rockwell Medical submits IND with FDA for proposed clinical trial of FPC - Rockwell Medical announced that it has submitted an Investigational New Drug, IND, application with the U.S. Food and Drug Administration, FDA, in support of its proposed Phase 2 clinical trial of Ferric Pyrophosphate Citrate, FPC, designed for the treatment of iron deficiency anemia and maintenance of hemoglobin in patients receiving infusion therapy in the home setting. "Home infusion represents a large and rapidly growing segment of healthcare. Many patient groups requiring home infusion therapies suffer from chronic diseases that are associated with a high incidence of iron deficiency and anemia," said Marc Hoffman, M.D., Chief Medical Officer of Rockwell Medical. "Current treatment patterns can be inadequate for patients on home infusion therapy with iron deficiency anemia, causing them to suffer extreme fatigue, and can result in serious health risks." Once the IND is submitted, a sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND.

08:31 EST Tapestry continues to see $300M in structural gross run rate expense savings

08:30 EST Tapestry sees 'modest' gross margin pressure due to freight investments for FY

08:29 EST Tapestry: Suppy chain headwinds constricting inventory availability

08:27 EST Freshworks announces new Freshservice capabilities - Freshworks at its Refresh conference unveiled new Freshservice capabilities that mark the company's move deeper into the $34B IT Operations Management market. The company said, "Affordable and easy-to-use, Freshservice's unified incident response management with AI-enhanced alerting enables any business to anticipate service disruption and minimize impact. The new Freshservice capabilities, available in November, help IT and engineering teams increase efficiency and reduce downtime. Instead of many manual hours spotting critical alerts and creating or routing tickets in IT service desks, they can focus on root-causing and fixing the problem at hand. On-call Management helps IT teams to immediately respond to critical incidents and kickstart collaboration between IT and devops teams to prevent service outages. Automated Alert Grouping with machine learning helps reduce alert noise to identify the most pressing issues first and minimize business impact."

08:25 EST Tapestry CEO: Sales now 9% above pre-pandemic levels - Comments taken from Q1 earnings conference call.

08:25 EST Apollo Global names Toby Myerson as Senior Advisor to Apollo Japan - Apollo announced that Toby Myerson has been named as a Senior Advisor to Apollo Japan. Myerson is a veteran of the legal and finance industry with a long history of doing business in Japan, including building the Japan practice for Paul, Weiss, Rifkind, Wharton & Garrison. Myerson joins Apollo as the firm continues to grow its asset management and retirement services business in Japan and the broader Asia Pacific region. "The addition of Toby is another step in Apollo's recent expansion in Japan. This year Apollo's private equity business has completed or announced two significant and complex corporate carveouts in Japan - one with Mitsubishi Chemical and another with Showa Denko - showcasing its ability to help major corporations execute on their corporate objectives. Additionally, the firm's strategic partner Athene recently completed two reinsurance transactions with Japanese insurance companies, helping to provide Japanese individuals with safe retirement income products," the company said. In addition to serving as Senior Advisor to Apollo, Myerson is the CEO and Chairman of Longsight Strategic Advisors, a business advisory firm he founded in 2017.

08:22 EST CymaBay to host KOL webinar of seladelpar for primary biliary cholangitis - CymaBay Therapeutics announced that it will host a Key Opinion Leader webinar on seladelpar for primary biliary cholangitis on Monday, November 15, at 4:30pm EST. The webinar will feature presentations by Professor Marlyn Mayo, M.D. and Professor Cynthia Levy, M.D. who will both discuss the abstracts that were presented at The Liver Meeting Digital Experience 2021 of the American Association for the Study of Liver Diseases. Dr. Mayo will discuss the efficacy and safety of seladelpar during 2 years of treatment in patients with primary biliary cholangitis and Dr. Levy will highlight the treatment effects of seladelpar in compensated cirrhotic patients with portal hypertension after 3 months, which led to ALP changes of -30% in the 5 mg and -45% in the 10 mg groups. Dennis Kim, M.D., Chief Medical Officer of CymaBay, will also discuss the company's progress developing seladelpar for patients with PBC. Seladelpar is a potent, selective, orally active peroxisome proliferator-activated receptor agonist in development for the treatment of patients with the autoimmune liver disease, primary biliary cholangitis. Backed by an extensive body of clinical evidence and global patient experience through its Phase 2 and Phase 3 studies of seladelpar in Primary Biliary Cholangitis, CymaBay initiated an international pivotal Phase 3 study in early 2021.

08:19 EST Whitestone REIT announces restaurants opening in second-generation dining spots - Whitestone announces some second-generation restaurant spots that have been recently announced at Whitestone's properties in Arizona and Texas. Hudson House, Las Colinas. Hudson House is taking over a 5,200-square-foot space previously occupied by another restaurant. Prey, Houston. Prey is taking a spot in Houston, close to the Galleria. Thompson 105, Scottsdale. Thompson 105 will be opening at Scottsdale's Desert Canyon shopping center. It's expected to debut in January. Gabriella's Contemporary American Cuisine, Scottsdale. Gabriella's Contemporary American Cuisine is opening at Whitestone's The Mercado at Scottsdale Ranch.

08:16 EST AllCloud, AWS expand strategic collaboration for cloud migrations - AllCloud announces an expanded strategic collaboration with Amazon Web Services. The collaboration, which began last year in Germany, Austria, Switzerland and Israel, will now include North America. Through the collaboration, AllCloud will provide clients with professional and managed services to accelerate their cloud migration and digital transformation. In December 2020, AllCloud and AWS announced a strategic collaboration to support Medium and Large Enterprise clients in EMEA. The new agreement expands the scope of work to include ISVs, manufacturing and consumer goods clients in the North American market. AllCloud will provide these organizations with services and solutions built around its expertise in cloud migration, Microsoft workloads, DevOps, security, data, analytics and AI/ML.

08:13 EST Just Energy obtains extension of stay period order under CCAA - Just Energy Group announced that the Ontario Superior Court of Justice has, among other things, approved the extension of the stay period under the Companies' Creditors Arrangement Act to February 17, 2022; and an amendment to the CCAA Interim Debtor-In-Possession Financing Term Sheet between the Company and the DIP lenders to, among other things, extend the maturity of the DIP Facility to September 30, 2022. The Stay Extension and DIP maturity extension allow the Company to continue to operate in the ordinary course of business while pursuing a restructuring plan with its stakeholders. In addition, further to the Company's announcement on November 1, 2021, the Court approved Just Energy entering into a support agreement with an affiliate of Generac Holdings to vote in favour of the acquisition of Just Energy's shares of ecobee Inc. by Generac.

08:11 EST Happiness Biotech changes name and re-designates ordinary shares - Happiness Biotech will change its name to "Happiness Development Group Limited" effective on November 12. In addition, the company re-designated its authorized ordinary shares, par value $0.0005 each, into Class A ordinary shares, par value $0.0005 each, and Class B ordinary shares, par value $0.0005 each, on an one-for-one basis. The issued and outstanding ordinary shares will all be re-designated as Class A ordinary shares, except that 12,045,100 issued and outstanding ordinary share held by Happy Group Inc., an entity controlled by Xuezhu Wang, the CEO and chairman of the Company will be re-designated as 12,045,100 Class B ordinary shares, and that 150,000 issued and outstanding ordinary shares held by Xuezhu Wang will be re-designated as 150,000 Class B ordinary shares. The Class A ordinary shares continue to be listing on the Nasdaq Capital Market under the symbol of "HAPP". Currently, there is no public market for the Class B ordinary share.

08:10 EST AEye appoints Dr. T.R. Ramachandran as chief product officer - AEye announced the appointment of Dr. T.R. Ramachandran as chief product officer. Ramachandran, who has more than two decades of experience delivering complex, market-leading solutions to large global customers, will report to AEye CEO Blair LaCorte. His hiring comes amid rapid growth for AEye, as the company builds out its management team and expands globally to meet accelerating market demand for its adaptive LiDAR. Ramachandran brings over 23 years of experience in the technology industry to his new position, including global product launches and related marketing activities. Prior to AEye, he led marketing and product management at LiDAR companies Cepton and Velodyne. His deep experience in the LiDAR industry extends across several key markets, such as autonomous vehicles, advanced driver assistance systems, intelligent transportation systems, and security.

08:07 EST Psomagen partners with Olink Proteomics for multi-omics clinical studies - "Psomagen, a North American sequencing-based contract laboratory service and data analysis provider with both CLIA-certified and CAP-accredited facilities, has partnered with Olink Proteomics, which offers an innovative DNA-coupled immunoassay that identifies and quantifies protein biomarkers in clinical samples. The partnership enables end-to-end multi-omics clinical studies, a step that will enable a whole new generation of precision therapies derived from a more robust knowledge of human biology," the companies said. "This is the kind of partnership that can transform the pharmaceutical industry," said Take Ogawa, Chief Commercial Officer at Psomagen. "Today, drug developers are piecemealing together information from clinical research that is disjointed and resource-draining, but that is about to change." Olink's technology - called the Proximity Extension Assay, uses antibodies with DNA tags that when hybridized with extremely high specificity, can measure the protein profile in patient samples using next-generation sequencing and qPCR. Psomagen's 17-year history as a genomic sequencing and data analysis service provider makes it uniquely qualified to help drug developers add proteomics to their research strategies in this capacity. "Olink's technology is a natural extension of our current service offerings," said Su Hong, Ph.D., Director of Strategy Development at Psomagen. "The fact that we have CLIA-certified and CAP-accredited facilities will open new doors for trailblazers who are pushing the limits of the role proteins play in developing new therapeutics."

08:07 EST Super League Gaming, Screenvision Media expand partnership - Super League Gaming (SLGG) and Screenvision Media announced the launch Super League Spotlight, an exciting multi-episode series showcasing the best in-game action, created specifically for in-theater audiences. The first installment of the series launches today in over 2000 movie theaters nationwide. Super League and Screenvision's Super League Spotlight series presents top highlights from the live stream broadcasts of popular gaming influencers within Super League's established Core Gamer and Young Gamer networks. "With an average two-minute run time, each episode of Spotlight amplifies the best and most exciting in-game moments of the past month," the company said. Hyundai (HYMTF) will serve as the initial series sponsor as part of a year-long partnership with Super League.

08:05 EST PharmaTher announces research results from psilocybin microneedle patch - PharmaTher Holdings (PHRRF) announced that it has completed its first research study evaluating MicroDose-MN, a proprietary microneedle patch for the intradermal delivery of psychedelics, in delivering psilocybin. These results provide support to file for an IND application with the FDA to conduct Phase 2 clinical studies in 2022 with psilocybin for various indications. The aim of PharmaTher's research program was to develop a suitable prototype of MicroDose-MN patch for transdermal drug delivery to confirm compatibility and suitability to deliver psilocybin. The research program scope included, full characterization of psilocybin conjugated on the microneedle patch backbone, establishment and demonstration of the loading capacity for psilocybin, and release rate evaluations for the psilocybin conjugated materials using appropriate models that will be used to support the Company's IND application with the FDA. The Company's research program with psilocybin conjugated microneedles have been successfully fabricated, optimized, and characterized. Both structural aspects and ex-vivo skin insertion assessments of the psilocybin conjugated microneedles have demonstrated successful fabrication and acceptable performance. The incorporation of psilocybin per microneedle without issue and the ability to demonstrate complete ex vivo skin model release over several days demonstrates potential for larger doses and modified release profiles. With these results, the Company believes it has an acceptable prototype for completing IND-enabling studies with the aim to conduct clinical studies in 2022. Details of the research program will be published in a scientific journal. The Company previously announced that it has entered into a collaboration agreement with Revive Therapeutics (RVVTF) for the evaluation of the psilocybin MicroDose-MN patch and is currently in discussions with Revive in finalizing a definitive agreement to advance the clinical and commercial development. The Company believes that its MicroDose-MN(TM) patch for delivering psilocybin and other psychedelics may enable flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles. In addition, the MicroDose-MN patch for psychedelics aims to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office or hospital. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch. The Company is completing its evaluation of MicroDose-MN with 3,4-methylenedioxy-methamphetamine, lysergic acid diethylamide , and N, N-dimethyltryptamine and expects to provide results before the end of this year and pursue clinical studies in 2022. The Company is actively engaged in partnering discussions for the use of its microneedle patch system to deliver psychedelics including, but not limited to, MDMA, LSD, DMT, ibogaine and mescaline. As such, PharmaTher offers potential partners a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards clinical studies in 2022.

08:03 EST PAE awarded USPS contract valued at $63.5M for supporting mail transport center - PAE has been awarded a contract supporting the U.S. Postal Service at the Mail Transport Equipment Service Center in Los Angeles. The contract is valued at $63.5M if all options are exercised. PAE Interim President and CEO Charlie Peiffer said "Keeping with our strategy of expanding the reach of our existing capabilities, PAE will deliver proven innovations and continuous improvement practices for the U.S. Postal Service at its Los Angeles MTESC," Peiffer said. "Our support of MTESC operations around the country position us to successfully provide key management and customer service solutions for critical USPS functions." The three-year base contract may be extended to seven years through two options and includes the processing and management of mail transport equipment used to enclose and transport mail. MTESCs throughout the United States manage and ship transport equipment to USPS and USPS customer facilities.

07:51 EST Shapeways expands Desktop Metal system capacity to additional facilities - Shapeways Holdings (SHPW) and Desktop Metal (DM) unveiled a landmark partnership to offer manufacturing and engineering teams unprecedented flexibility and seamless access to industry-leading 3D printing services. Consistent with the strategic partnership the parties entered into in early 2021, Shapeways is expanding Desktop Metal system capacity and capabilities by providing customers access to these solutions at Shapeways' ISO-9001 manufacturing facilities in both Long Island City, New York and Eindhoven, Netherlands. In addition, Desktop Metal plans to leverage Shapeways' manufacturing capabilities and purpose-built software platform, Otto, to provide its customers with instant access to fully digitized, end-to-end 3D printing workflows. "We're extremely pleased to progress our partnership with Shapeways and propel the additive manufacturing industry forward," said Ric Fulop, Founder and CEO of Desktop Metal. "For customers starting their digital manufacturing journeys who may not be ready to purchase equipment of their own, Shapeways will offer instant access to Desktop Metal's comprehensive portfolio of high-speed, AM 2.0 printing platforms and rich materials library, enabling them to benefit from expedited production, reduced costs, and flexible, overflow manufacturing capacity as dictated by growing business demands."

07:40 EST American Noble Gas announces new advisory board - American Noble Gas announced it has entered into formed a new advisory board containing four noble gas industry members. The advisory board will provide unique guidance and experience to the Company as it evaluates its reserve potential of noble gases, specifically including helium, relative to its recently acquired 11,000-acre oil & gas properties in the Otis/Albert Field located on the Kansas Central Uplift. In addition, AMGAS would like to inform its shareholders about its expansion towards the exploration and production of natural gas, helium, and other noble gases in addition to traditional crude oil production. While we are pleased and continue to be very positive on oil production and have been working closely with the Kansas Tertiary Oil Recovery Program in proving our oil reserves we have uncovered substantial evidence to believe there is natural gas, helium and other noble gases present on our Central Kansas Properties. The Company has been and continues to test its Central Kansas Properties for the possible existence of noble gas reserves and such tests have yielded positive but as yet not conclusive results. The members of the advisory board collectively, are to receive warrants to purchase 1,200,000 common shares with an exercise price of $0.50 per share for a period of five years. The board includes Mssrs. Tom Harrison, Chris Ballentine, Jon Gluyas and Paul Mendell. Harrison is currently Vice President of Industrial Gases at Iwatani Corporation of Japan which is a leading industrial gas company in Japan. Ballentine is the Chair of Geochemistry at the University of Oxford. Gluyas is Executive Director of Durham Energy Institute at Durham University UK. Mendell developed a novel gaseous delivery technology that is being evaluated by different industries and he co-founded a company around this technology called Onza Corp. On November 5, 2021, the Company and USNG entered a Letter Agreement which covers terms and conditions under which USNG will provide consulting services to the Company for exploration, testing, refining, production, marketing and distribution of various potential reserves of noble gases and rare earth element/minerals on the Company's recently acquired Properties. The Letter Agreement will cover all of the noble gas and rare earth elements/minerals potentially existing on the approximate 11,000 acres included in the Company's Properties and future acquisitions. The Letter Agreement also provides that USNG will supply a gas extraction/separator unit which is a large vessel designed for flows up to 5,000 barrels of water per day at low pressures. It is a dewatering vessel that could be used for multiple wells in the future. USNG will also supply a gas metering device currently being installed on the Company's test well. The equipment US Noble delivers free of charge shall belong to AMGAS along with all data and proprietary information regarding gases and minerals collected. USNG will receive as consideration The Company will issue warrants to issue 2,000,000 shares of common stock at an exercise price of $0.50 for a five-year term as consideration for the Letter Agreement to the principal consultants involved with USNG. USNG will also receive a monthly cash fee equal to $8,000 per month beginning at the onset of commercial helium or minerals production and sales, subject to certain thresholds. Such monthly fees will become due and payable for any month that AMGAS receives cash receipts in excess of $25,000 derived from the sale of noble gases and/or rare earth elements/minerals. In addition to the services of Paul Mendell who is a member of the Company's Advisory Board, pursuant to the Letter Agreement,' USNG will provide AMGAS with services from the following consultants including their capacities: Brian Weaver will act as the Company's consulting stimulation engineer and assist in all well and frac designs as well as helping with preparing internal financial forecast for the company's projects. Brian is a mechanical engineer and an MBA that currently consults for Liberty Frac. Eric Anderson as professional landman will provide advice and services with respect to contracts, land acquisitions and other matters related to the company's acquisition of land and mineral rights for the exploration and development of noble gases. Both Brian and Eric will be bound by the same non-compete as the advisory board members.

07:35 EST Arbutus Biopharma appoints Tram Tran to board of directors - Arbutus Biopharma announced that Tram Tran, M.D. has been appointed to the Arbutus Board of Directors effective immediately. Dr. Tran is a liver and viral specialist with over 20 years of academic and industry experience as a physician scientist. Tran currently serves as Chief Medical Officer at Glympse, a biotech company focused on optimizing disease diagnosis and monitoring.

07:34 EST Algoma plans to invest C$700M in electric-arc-furnace transformation - Algoma Steel Group announced that its Board of Directors has authorized the Company to construct two new electric-arc-furnaces to replace its existing blast furnace and basic oxygen steelmaking operations. The transformation is expected to reduce Algoma's carbon emissions by approximately 70%. Following the transformation to EAF steelmaking, Algoma's facility is anticipated to have an annual raw steel production capacity of approximately 3.7 million tons, matched to Algoma's downstream finishing capacity, and is also anticipated to include new vacuum degassing capability to expand Algoma's offering of steel plate grades. The company said, "Algoma has employees and leadership with experience constructing and operating EAF steel mills in addition to downstream value-add finishing lines. Coupled with Algoma's current investments in the Direct Strip Production hot rolling mill and its modernized plate mill project, the Company believes the enhanced capabilities expected to result from the EAF transformation will position Algoma as a competitive, energy-efficient, lower environmental impact steelmaker." The Company plans to invest approximately C$700M in the EAF transformation, funded with previously announced financing commitments and the proceeds related to the Company's recently completed merger. Algoma anticipates a 30-month construction phase for the EAF facility, coming online in 2024, and expects to transition away from blast furnace steelmaking thereafter as more electric power on the grid supplying Algoma becomes available.

07:28 EST Skylight Health announces offering of Series A Preferred Shares - Skylight Health Group announced the launch of a proposed underwritten public offering of its Series A Cumulative Redeemable Perpetual Preferred Shares. The Series A Preferred Shares are entitled to cumulative dividends of 9.25% payable monthly and are redeemable by the Company, at a price of US $25.00 per share, at the Company's option any time on or after three years from closing. In connection with this offering, the Company expects to grant the underwriter a 30-day option to purchase Preferred Shares. The Company plans to contribute the net proceeds it receives from the offering to evaluating and completing possible acquisitions of clinical and medical services businesses, establishing primary care and sub-specialty services within existing facilities, including HR and capacity development, and working capital.

07:21 EST Nabriva Therapeutics announces availability of XENLETA in 10-count oral pack - Nabriva Therapeutics announced the oral formulation of XENLETA is now available in a 10-count oral pack in the U.S. through major specialty distributors. XENLETA is the first oral and IV treatment in the pleuromutilin class of antibiotics. XENLETA has in vitro activity and demonstrated clinical efficacy against the most common pathogens that cause community-acquired bacterial pneumonia, CABP. XENLETA has a novel mechanism of action that targets a binding site on bacterial cells that is different from existing antibiotics, resulting in a low propensity for the development of resistance, as well as a lack of cross-resistance with antibiotic classes commonly used for the treatment of CABP. "This new package size offers pharmacies an option to expand product availability in a cost-effective way to service their local patients and physicians by providing patients a convenient package that contains a complete 5-day course of oral treatment for CABP," said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. "Our community-based sales force is excited to communicate the availability of the 10-count oral pack - or 'X' pack to their target customers."

07:17 EST In8bio to present preclinical data for gamma-delta T-cell therapy combinations - IN8bio announced a poster presentation of preclinical data demonstrating the potential of its cellular therapies in combination with Poly polymerase, PARPi, and checkpoint inhibitors, which may enhance the recognition and killing of cancer cells by its DeltEx drug resistant immunotherapy, DRI, gamma-delta T cells. Kate Rochlin, Ph.D., Vice President, Operations and Innovation at IN8bio, will present on the potential uses of such therapeutic combinations to drive tumor immunogenicity in the solid tumor setting at the 36th Annual Meeting of the Society for Immunotherapy Conference, SITC. Dr. Rochlin will present work that has been conducted as part of a collaboration with the Hjelmeland Laboratory at the University of Alabama at Birmingham, which demonstrated that chemotherapy, in this case temozolomide plus PARPi increases expression of stress ligands on solid tumor cell lines in vitro. In some cell lines up to a 29x increase in mRNA expression of NKG2DL was observed. Increases were seen in both classical and proneural human glioblastoma lines as well as in SB28 cells. SB28 is a treatment and checkpoint resistant glioma cell line used in syngeneic mouse models that is thought to closely resemble treatment responses of human tumors. This suggests that gamma-delta T-cell therapy could be enhanced through the use of orthogonal therapeutic combinations that drive increased tumor cell immunogenicity.

07:15 EST Baudax Bio announces clinical program update for NMBs BX-1000, BX-2000, BX-3000 - Baudax Bio announced a clinical program update for its neuromuscular blocking agents, NMBs, including completion of a dose-escalation study evaluating BX-1000 in healthy volunteers. Baudax's proprietary NMBs are BX-1000, an intermediate duration NMB, BX-2000, an ultra-short duration NMB, and BX-3000, a reversal agent that rapidly reverses the effects of BX-1000 and BX-2000. Used together, these agents to allow a very rapid induction of neuromuscular blockade for surgical settings, followed by a rapid reversal of the neuromuscular blockade. BX-1000: A total of 58 subjects participated in a dose-escalation study evaluating, BX-1000. Per FDA guidance and feedback, the evaluation of BX-1000 was conducted in healthy volunteers who had already undergone endotracheal intubation while under general anesthesia. After intubation, subjects received a single IV bolus dose of BX-1000 and were monitored. Overall BX-1000 was generally well tolerated through the dosing range tested. Muscle paralysis was rapidly achieved along with complete spontaneous recovery. Baudax is preparing the clinical study report for this dose-escalation study and expects to submit it to FDA early in the New Year. Meanwhile Baudax is finalizing plans to proceed to the next study in surgical patients that is expected to commence by about mid-year 2022. BX-2000: BX-2000, an ultra-short acting NMB which began dosing this month. Baudax expects to submit the report for this toxicology study for BX-2000 to the FDA during the first quarter of 2022. BX-3000: BX-3000 was designed to induce chemical cleaving of BX-1000 and BX-2000. Baudax expects to initiate the clinical program for BX-3000 during late 2022.

07:13 EST Tapestry CEO says 'revenue trends accelerated compared to pre-pandemic levels' - Joanne Crevoiserat, CEO of Tapestry, said, "We delivered another quarter of solid performance, reflecting strong customer engagement and increased demand for our brands. Importantly, revenue trends accelerated compared to pre-pandemic levels driven by North America, as well as continued growth in Digital and China - two key drivers of long-term opportunity. Tapestry's standout results highlight our teams' extraordinary execution and the foundational changes we've made to transform into a more consumer-centric, data-driven, and responsive organization through the pillars of our Acceleration Program. Overall, this performance reaffirms our conviction in our ability to fuel continued revenue and profit gains. While supply chain challenges persist due to the global pandemic, we're remaining agile and taking deliberate actions to meet growing consumer demand. The incremental share repurchase program announced today further underscores our confidence in the strength of our brands and our ability to drive sustainable growth. Taken together, we are increasing our revenue and EPS outlook for the fiscal year, reflecting our first quarter performance and strong underlying business trends. We remain sharply focused on accelerating growth and profitability and are committed to creating value for all stakeholders."

07:12 EST Gamida Cell delays omidubicel BLA submission to FDA till 1H22 - Gamida Cell completed a Type B Pre-Biologics License Application BLA meeting with the U.S. Food and Drug Administration FDA for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. The FDA requested that Gamida Cell provide revised analysis of the manufacturing data generated at Gamida Cell's wholly-owned commercial manufacturing facility to demonstrate the comparability to the omidubicel that was produced at the clinical manufacturing sites for the Phase 3 study. The FDA did not request additional clinical data to initiate the BLA submission once analytical comparability is demonstrated. The company will continue to work collaboratively with the FDA and anticipates submitting the BLA in the first half of 2022 in lieu of the company's previous plan to submit the BLA by the end of 2021. "Despite the delay in timing to bring omidubicel to patients after a potential FDA approval, we are encouraged by the FDA's reaction to our Phase 3 data as the pivotal trial of omidubicel. We have gained further clarity with the FDA on the requirements for demonstrating comparability for our commercial manufacturing facility," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "With the FDA's feedback in hand, we believe that we are one step closer for omidubicel to be made available to patients in need."

07:10 EST Sio Gene successfully manufactures three GMP batches of AXO-Lenti-PD - Sio Gene Therapies provided a manufacturing and regulatory update for AXO-Lenti-PD, its clinical-stage gene therapy for Parkinson's disease. Key Highlights: Three GMP batches have successfully completed fill and finish, achieving target titers using the updated suspension-based process; the company is on-track to complete final testing of these three batches to support certification of at least one batch for use as clinical trial material by a Qualified Person in Q4 2021; the Company successfully completed a scientific advice meeting with the Medicines and Healthcare Products Regulatory Agency, MHRA, in the U.K. regarding the AXO-Lenti-PD clinical development program. The MHRA provided guidance on the appropriate development pathway for completion of the Phase 1 dose-ranging study, acceptability of a comparability protocol between the prior adherent and new suspension manufacturing process, and new device administration system to support bilateral simultaneous infusions; and expects to provide a program update in Q1 2022

07:06 EST Alkermes says first patient dosed in Phase 1 study of ALKS 1140 - Alkermes announced dosing of the first subject in a phase 1 study evaluating the safety and tolerability of ALKS 1140 in healthy adults. ALKS 1140 is a novel, investigational CoREST-selective HDAC inhibitor candidate for the treatment of neurodegenerative and neurological disorders. ALKS 1140 is designed to increase functional synaptic connections and synaptic integrity in the brain.

07:06 EST Charles River promotes Birgit Girshick to COO - Charles River announced that Birgit Girshick has been promoted to the position of COO, effective immediately. In her most recent role as corporate executive VP, Girshick has been responsible for oversight and leading the strategic direction of the Discovery Services, Safety Assessment, and Biologics Solutions businesses. She has also been overseeing the integration of the Cognate BioServices and Vigene Biosciences acquisitions, as well as the future growth strategy for the company's Cell and Gene Therapy CDMO business. In her new role as executive VP and COO, and in addition to her current responsibilities,

07:04 EST Compugen expands collaboration with Bristol-Myers - Compugen (CGEN) announced that Bristol Myers Squibb (BMY) completed its $20M investment in Compugen in consideration for the issuance of 2,332,815 shares of Compugen purchased at $8.57333 per share, representing a 33% premium over the closing price on November 9. As part of the expansion of the collaboration, a joint steering committee has been formed to facilitate strategic oversight and guidance for the programs run under the collaboration. This will run alongside the existing joint development committee which acts at an operational level.

06:59 EST ANI Pharmaceuticals receives FTC clearance for acquisition of Novitium Pharma - ANI Pharmaceuticals announced that the U.S. Federal Trade Commission has accepted the proposed consent order in connection with ANI's definitive agreement to acquire Novitium Pharma. The divestitures required by the FTC of development rights to one generic drug and assets with respect to another generic drug are immaterial to the company's business. The acceptance by the FTC satisfies all required antitrust clearances needed to be obtained for the acquisition of Novitium Pharma by ANI. The closing of the acquisition remains subject to other customary closing conditions set forth in the purchase agreement. ANI currently expects that the acquisition will be completed on or about November 18.

06:53 EST Tapestry announces new $1B share buyback authorization - Given Tapestry's first quarter results, robust balance sheet, significant free cash flow generation, and outlook for growth, the company's Board of Directors approved an incremental $1B share repurchase program. As a result, Tapestry now expects to return approximately $1.25B to shareholders in Fiscal 2022, a meaningful increase from the previous outlook.

06:49 EST Merck initiates Phase 3 study evaluating VERQUVO - Merck announced the initiation of VICTOR, a pivotal Phase 3 randomized, placebo-controlled cardiovascular clinical trial of VERQUVO in patients with chronic heart failure and reduced ejection fraction of 40% or less who have not had a recent worsening heart failure event. Recruitment for the VICTOR trial has begun. The study is slated to enroll approximately 6,000 adults with chronic heart failure and reduced ejection fraction who have not been hospitalized for heart failure for 6 months or received outpatient IV diuretic use within 3 months prior to randomization. The primary efficacy endpoint is the time to first event of cardiovascular death or hospitalization for heart failure.

06:45 EST DarioHealth announces three new contracts - DarioHealth announced that it has contracted with two new employers and a new provider partner channel to provide the company's digital therapeutic solutions beginning in Q1. Dario's multi-chronic digital therapeutics platform includes programs for diabetes, pre-diabetes, hypertension, weight management, musculoskeletal and behavioral health integrated across one AI-driven behavior change engine. This single platform approach ensures participants in any program receive holistic digital and live behavior change support informed by data from the more than 208,000 users across all solutions to encourage lasting changes. The new employer clients include a southwest regional employer in the health care industry contracting for behavioral health, and a midwestern employer in the food industry contracting for behavioral health with Employee Assistance Programs. The new provider contract gives Dario access to a wide range of providers through a unique strategic partnership that will launch with Dario's Remote Patient Monitoring solution for hypertension in one practice in California, before expanding access to additional practices throughout 2022.The diversity of the conditions across the three contracts further demonstrates the power of having a multi-condition platform.

06:37 EST Organon CEO says YTD results 'very much in line with expectations' - "Just months after becoming a standalone company, we are delivering on what we set out to do. Our year to date results are very much in line with expectations, and with good visibility into the remainder of the year, we are affirming our financial guidance," said Kevin Ali, Organon's CEO. "Importantly, we have also been disciplined in actioning business development opportunities that have been in the works well prior to spin. Including today's announcement regarding the proposed acquisition of Forendo Pharma, we have executed three transactions in the last six months, demonstrating our commitment to advance innovation in large, underserved markets, which women's health has lacked for decades."

06:34 EST Outbrain sees Q4 adjusted EBITDA $22.5M-$23.5M - Sees Q4 ex-TAC gross profit $74.5M-$76.5M.

06:32 EST Organon to acquire Forendo Pharma for up to $954M - Organon and Forendo Pharma announced that the companies have entered into a definitive agreement, under which Organon will acquire Forendo, a clinical-stage drug development company focused on novel treatments in women's health. Forendo is pioneering the science of intracrinology, addressing disease through a novel, tissue-specific approach. Its lead clinical compound is an investigational, potentially first-in-class oral 17beta-hydroxysteroid dehydrogenase type 1 inhibitor in early clinical development for endometriosis, being evaluated for its potential effect on endometriotic lesions. Consideration for the transaction includes a $75M upfront payment, assumption of approximately $9M of Forendo debt, payments upon the achievement of certain development and regulatory milestones of up to $270 million and commercial milestones payments of up to $600M, which together could amount to total consideration of $954M. Completion of the transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in December.

06:08 EST Gravity says 'Ragnarok Origin' officially launched in U.S., Canada on Nov. 10 - Gravity announced that Ragnarok Origin, a MMORPG mobile game, has been officially launched in the United States and Canada on November 10. Ragnarok Origin, previously released in South Korea and Japan, started services with over 700,000 pre-registered accounts from August 10 with enormous expectations. On the launching day, the game ranked as the second in free download of Google Play in the United States.

06:05 EST Clean Energy, BP broaden RNG joint venture - Clean Energy (CLNE) and BP (BP) announced that its renewable natural gas joint venture will build on previously announced plans to finance and develop new projects at dairy farms, starting in the Midwest. Located in South Dakota and Iowa, the dairy farms, with more than 30,000 cows, have the estimated potential to convert the methane produced from waste into more than seven million gallons of RNG annually. Dynamic Holdings will oversee construction and develop and operate the facilities following the execution of an agreement with the joint venture to execute multiple phases of dairy RNG projects. The first RNG production facility is expected to be operational in 2022.

06:04 EST Tesla Model 3 was traveling 90 mph before fatal September crash, says NTSB - A preliminary report from the National Transportation Safety Board determined that a Tesla Model 3 involved in a fatal crash in Coral Gables, Florida in September was traveling 90 mph in a 30 mph zone. The vehicle was traveling in a residential area before it crashed into two trees and caught fire. The EDR data showed that the Model 3's accelerator pedal had been applied during the incident, and the service brake also remained off. "Preliminary evaluation of the data indicated that application of the accelerator pedal ranged from 0 to 100%, the service brake remained off, and the maximum recorded vehicle speed was 90 mph," the NTSB's preliminary report noted. Reference Link

05:32 EST Faraday Future receives COO for California manufacturing plant - Faraday Future announced that it received the Certificate of Occupancy, or COO, for the major manufacturing area of its Hanford, California manufacturing plant, delivered by Francisco Ramirez, Mayor of Hanford. The completed portion of the plant will be used to assemble the final group of pre-production builds of the FF 91 EV. The company said, "The first COO opens the gates for FF employees to build additional pre-production vehicles for final testing and validation before production officially begins. Previously, only construction-related resources and personnel were able to work out of the facility. The Hanford plant will be a state-of-the-art facility that uses leading-edge automated production processes and highly skilled craftsmanship to rival the top luxury automakers of the world. FF is also ramping up hiring at the plant, as well as across more functions such as engineering, supply chain, design, marketing, brand, sales and other areas."

05:17 EST Elbit Systems awarded $74M in contracts from Republic of Korea Air Force - Elbit Systems announced that it was awarded contracts in an aggregate amount of approximately $74M from the Defense Acquisition Program Administration of the Ministry of National Defense of the Republic of South Korea, to supply a range of airborne munitions as part of the Precision Fires Program of the Republic of Korea Air Force. The contracts will be performed over a five-year period.

05:13 EST Inozyme enters pact with Genomenon to advance diagnosis of rare diseases - Genomenon announced a partnership with Inozyme Pharma to make information readily accessible to genetic testing labs and clinicians. This information will help inform diagnosis and thus treatment decisions in patients with ENPP1 Deficiency, a rare disease also known as generalized arterial calcification of infancy, or GACI, or autosomal recessive hypophosphatemic rickets Type 2, or ARHR2. To help inform and accelerate the diagnosis for patients of all ages with this disease, Genomenon produced a variant landscape for ENPP1 Deficiency. This AI-driven genetic dataset, along with information on available clinical trials and therapies, has been made available to doctors, researchers, and clinicians through Genomenon's Mastermind Genomic Search Engine.