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

18:47 EST Levi Strauss CEO: Lots of pent up demand among consumers - In an interview on CNBC's Mad Money, Chip Bergh said Levi's brand is incredibly strong and he's expecting a solid holiday season. "We have a great story to tell on ESG efforts," he added. The company is focused on reducing water and chemicals in its supply chain. Also, its "buy better, wear longer" advertising strategy really resonates with young consumers, he noted.

18:09 EST Conagra Brands issues voluntary recall of certain Birds Eye Broccoli Tots - Conagra Brands is voluntarily recalling Birds Eye Broccoli Tots in 12 ounce packages with specific best buy dates due to the potential presence of small rocks and metal fragments in the product. Conagra Brands was made aware of this issue through calls from consumers. Conagra Brands will work with retail customers to ensure that the recalled products are removed from store shelves. No other Birds Eye products are impacted by this issue.

18:00 EST Mogu receives NYSE non-compliance letter over ADS trading price - MOGU announced that it has received a letter from the New York Stock Exchange dated November 10, 2021, notifying the Company that it is below the compliance criteria in connection with the performance of its trading price in relation to the Company's American depositary shares. Pursuant to NYSE Rule 802.01C, a company will consider to be below compliance criteria if the average closing price of a security as reported on the consolidated tape is less than US$1.00 over a consecutive 30 trading-day period. Once notified, the company must bring its share price and average share price back above US$1.00 by six months following receipt of the notification. The company can regain compliance at any time during the six-month cure period if on the last trading day of any calendar month during the cure period the company has a closing share price of at least US$1.00 and an average closing share price of at least US$1.00 over the 30 trading-day period ending on the last trading day of that month. In the event that at the expiration of the six-month cure period, both a US$1.00 closing share price on the last trading day of the cure period and a US$1.00 average closing share price over the 30 trading-day period ending on the last trading day of the cure period are not attained, the NYSE will commence suspension and delisting procedures.

17:23 EST Raytheon Technologies unit selected by MDA to develop hypersonic interceptor - Raytheon Missiles & Defense, a Raytheon Technologies business, has been selected by the Missile Defense Agency as one of the companies to develop and test the first interceptor specifically designed to defeat hypersonic threats. The weapon, called Glide Phase Interceptor, will defeat a new generation of hypersonic missiles - weapons that travel more than five times the speed of sound and manuever rapidly in flight. GPI will intercept hypersonic weapons in the glide phase of flight, which occurs once a missile has re-entered Earth's atmosphere and is manuevering toward its target. The initial development phase will focus on reducing technical risk, rapidly developing technology, and demonstrating the ability to intercept a hypersonic threat. Developed on behalf of the MDA, GPI will be integrated into the U.S. Navy's Aegis Weapon System, a ship- and shore-based defense system.

17:20 EST Lockheed Martin awarded $584.84M Navy contract modification - Lockheed Martin was awarded a $584.84M cost-plus-incentive-fee modification to a previously awarded contract. This modification adds scope to provide system integration engineering for the development of new ASQ-239 electronic warfare/counter measure hardware in support of the F-35 aircraft for the Air Force, Marine Corps, Navy, and non-U.S. Department of Defense, or DOD, participants. Work is expected to be completed in April 2026. FY22 research, development, test and evaluation funds in the amount of $33.93M; FY22 research, development, test and evaluation funds in the amount of $33.93M and non-U.S. DOD participant funds in the amount of $14.95M will be obligated at the time of award, none of which will expire at the end of the current fiscal year. The Naval Air Systems Command is the contracting activity.

16:34 EST Cronos Group receives noncompliance letter from Nasdaq, provides MCTO status - Cronos Group provided a default status report in accordance with the alternative information guidelines set out in National Policy 12-203 - Management Cease Trade Orders and disclosing receipt of a Nasdaq Listing delinquency letter. On November 9, the company announced that it applied for a management cease trade order, or MCTO, with the applicable securities regulatory authorities in Canada on the basis that the company would be unable to file its quarterly report on Form 10-Q for the period ended September 30, with the U.S. Securities and Exchange Commission, together with its corresponding quarterly filings in Canada. The MCTO was issued on November 16 and restricts all trading in securities of the company, whether direct or indirect, by the CEO and CFO of the company until two full business days following the filing of the required filings and the MCTO has been revoked. The MCTO does not affect the ability of other shareholders of the Company to trade their securities. The company has received a written notice from the Listing Qualifications Department of Nasdaq, dated November 16, notifying the company that it is not in compliance with the requirements for continued listing set forth in Nasdaq Listing Rule 5250 because it did not timely file the Form 10-Q. The notice has no current impact on the listing or trading of the company's common stock on the Nasdaq Stock Market.

16:31 EST Community Bankers Trust announces special dividend - Community Bankers Trust Corporation, the holding company for Essex Bank, announced that its board has declared a special dividend of 4.42c per share with respect to the company's outstanding common stock. The dividend will be payable on December 2 to shareholders of record at the close of business on November 29. The special dividend is in addition to the company's quarterly dividend of 7c payable on December 1 to shareholders of record at the close of business on November 18.

16:07 EST Tilly's declares special cash dividend of $1.00 per share - Tilly's announced that its Board of Directors has declared a special cash dividend of $1.00 per share, or approximately $31M in the aggregate, on the company's outstanding Class A and Class B common stock. This one-time, special dividend is payable on December 15 to stockholders of record at the close of business on December 7.

16:07 EST Investors Bancorp announces shareholder approval of Citizens deal - Investors Bancorp, Inc. (ISBC) announced that stockholders of the company approved the planned merger with Citizens Financial Group (CFG) at a special meeting of the company's stockholders held earlier today. The transaction is expected to close in the first half of 2022, subject to the receipt of required regulatory approvals and other customary closing conditions. Kevin Cummings, Chairman and Chief Executive Officer, commented, "We are very pleased to have received overwhelming stockholder support for the planned merger with Citizens. Our customers, colleagues, communities and stockholders will benefit from Citizens' scale, capabilities and commitment to excellence."

16:03 EST Link Media Outdoor acquires Keleher outdoor advertising assets - Link Media Outdoor, a subsidiary of Boston Omaha, announced the purchase of the outdoor advertising assets of Keleher Outdoor Advertising, Inc. and Keleher Enterprises, Inc., based in Bartlesville, OK. Keleher was founded in 1975 and operates over 600 billboard faces in Oklahoma and southeast Kansas. These assets add new territory for Link, as well as complement Link's extensive Kansas inventory. Scott LaFoy, President and CEO of Link said, "Link is excited to enter the Oklahoma market and enhance our Kansas footprint as we expand our service to advertisers and customers in that area. Keleher Outdoor is a fine family business founded by Dan Keleher, Sr over 46 years ago. Dan Keleher, Jr and his wife Janie have done a great job further building the company and have been a pleasure to work with on this transaction. Link looks forward to continuing to build on this legacy." The transaction follows Link's acquisition of the assets of Thomas Outdoor Advertising in Manhattan, KS earlier in 2021, which added over 350 faces to the company's existing Kansas footprint. The inventory will be managed by Link's Kansas City office. "We found a quality buyer with Link," said Dan Keleher, Jr, president of Keleher. "We believe they share our sense of community and values for the type of markets we've done business in. We look forward to having them in Oklahoma." Max Drachman of Drachman M&A Co. represented the seller.

16:01 EST Breeze Holdings Acquisition requests deadline extension for business combo - Breeze Holdings Acquisition Corp. announced that its sponsor, Breeze Sponsor, LLC, requested that the ompany extend the date by which it has to consummate a business combination from November 25, 2021 to February 25, 2022. The Extension is the first of up to two three-month extensions permitted under the company's governing documents. In connection with such Extension, the Sponsor has notified the company that it intends to cause an aggregate of $1,150,000 to be deposited into the company's trust account on or before November 25, 2021.

15:29 EST CDC advisory committee backs booster shots for all adults - The CDC advisory committee voted 11 to zero that adults 18 and older may get a booster shot six months following their second mRNA Covid vaccine shot. On whether those aged 50 and above should get a booster, the panel also voted 11 to zero.

15:23 EST CDC advisory committee backs booster shots for all adults - The CDC advisory committee voted to 11 to zero that adults 18 and older may get a booster shot six months following their second mRNA Covid vaccine shot. On weather those aged 50 and above should get a booster, the panel also voted 11 to zero.

15:10 EST NBCUniversal announces six-year extension for U.S. Premier League rights - Comcast's NBCUniversal announced it has agreed to a six-year extension of its partnership with the Premier League and will exclusively present all 380 matches, studio programming, and additional content across NBC, USA Network, Peacock, Telemundo, Universo, and other platforms. "With the new agreement, which begins with the 2022-23 season next summer, NBC Sports, Peacock, and Telemundo Deportes will present the Premier League through 2028 - a span of 15 seasons for NBCUniversal as the exclusive U.S. media home of the world's best soccer league... NBC Sports is averaging a Total Audience Delivery of 609,000 viewers across its English- and Spanish-language Premier League television match windows this season - the highest viewership average through this point in the season since 2015-16 and up 14% from last year. NBC Sports is the home of 489 of the 500 most-watched live Premier League matches in U.S. television history," the company stated. Reference Link

14:23 EST AmpliTech agrees to buy assets, operations of Spectrum Semiconductor Materials - AmpliTech Group announced that it has executed a definitive agreement to acquire the assets and operations of Spectrum Semiconductor Materials, a specialty distributor of semiconductor components based in San Jose, CA. The transaction is expected to close within the company's fiscal year 2021, subject to the satisfaction of certain closing conditions. The purchase price is $8.0M in cash plus $1.5M to be held in escrow through December 2022, to fund any purchase price or other adjustments, plus the grant of 188,442 restricted shares of AmpliTech common stock. The parties have agreed to a purchase price adjustment of 25% of Spectrum's cumulative net revenue above or below $20M in sales for calendar years 2021 and 2022 combined. On September 30, AmpliTech notes it had approximately $28M in cash, cash equivalents, and marketable securities, and no long-term debt. "The purchase is expected to deliver significant strategic and top and bottom-line benefits while also building on AmpliTech's technical and management expertise and distribution reach. Spectrum is on track to achieve unaudited 2021 revenue of $10M - $11M, representing double-digit growth over Spectrum Semiconductor Materials sales in fiscal 2020, with 2021 pre-tax net income of approximately 25% of revenue. Spectrum achieves such strong net margins by stocking a wide variety of specialty products and employing disruptive digital inventory practices that optimize operating efficiency. AmpliTech's revenue for the past four quarters was $3.5M and recently announced a record order backlog of $3.4M following $1.2m in new orders. Spectrum Semiconductors has a record current order backlog of $8M in orders anticipated to ship through June 30, 2022," the company stated.

13:34 EST Micron says 'first semiconductor company to sample and validate' LPDDR5X DRAM - Micron Technology, at the MediaTek Executive Summit, announced that MediaTek has validated Micron's low-power double data rate 5X, or LPDDR5X, DRAM for MediaTek's new Dimensity 9000 5G flagship chipset for smartphones. "Micron is the first semiconductor company to sample and validate this fastest, most advanced mobile memory in the industry and has shipped the first batch of samples of LPDDR5X built on its first-to-market 1-alpha node. Designed for high-end and flagship smartphones, Micron's LPDDR5X allows the smartphone ecosystem to unlock the next wave of data-intensive applications powered by artificial intelligence and 5G innovation... Peak LPDDR5X speeds of 8.533 Gb/s deliver up to 33% faster performance than previous-generation LPDDR5," Micron stated in a press release. MediaTek's Dimensity 9000 mobile SoC will be the first to support LPDDR5X memory, the company noted.

13:03 EST Baker Hughes reports U.S. rig count up 7 to 563 rigs - Baker Hughes reports that the U.S. rig count is up 7 from last week to 563 with oil rigs up 7 to 461, gas rigs unchanged at 102, and miscellaneous rigs unchanged at 0. The U.S. Rig Count is up 253 rigs from last year's count of 310, with oil rigs up 230 gas rigs up 26 and miscellaneous rigs down 3. The U.S. Offshore Rig Count is unchanged at 15, up 3 year-over-year. The Canada Rig Count is down 1 from last week to 167, with oil rigs up 1 to 102, gas rigs down 2 to 65. The Canada Rig Count is up 66 rigs from last year's count of 101, with oil rigs up 60, gas rigs up 6.

12:41 EST Flipkart to acquire majority stake in Sastasundar Marketplace - Walmart-backed Flipkart announced its foray into the healthcare sector through the launch of Flipkart Health+. As part of this development, the Group has signed definitive agreements to acquire a majority share in Sastasundar Marketplace Limited, which owns and operates SastaSundar.com, an online pharmacy and digital healthcare platform, as it focuses on providing consumers access to affordable and convenient healthcare. Flipkart said that Flipkart Health+ will leverage the combined strengths of the Flipkart Group, which includes its pan-India reach and technology capabilities, with SastaSundar's deep expertise to provide consumers end-to-end offerings in the health-tech ecosystem. It will endeavour to give millions of Indian consumers access to quality and affordable healthcare, starting with e-pharmacy and will add new healthcare services such as e-diagnostics and e-consultation over time. Flipkart Health+ will report to Ajay Veer Yadav, Senior Vice President and Flipkart veteran. Reference Link

12:31 EST City Holding boosts quarterly dividend by 3% to 60c from 58c - City Holding declared a dividend of 60c per common share for shareholders of record as of January 14, 2022. The dividend is payable on January 31, 2022. The dividend represents a 3.45% increase from the 58c per share cash dividend paid in Q3. "Our board once again voted to increase the quarterly cash dividend by 2 cents to 60 cents," stated Charles Hageboeck, President and CEO. "This increase reinforces the Company's commitment of returning value to its shareholders. The decision to increase the dividend to $2.40 on an annualized basis is based on the Company's current strong capital and liquidity position, our financial performance during 2021, and our confidence in the Company's ability to sustain this performance."

12:00 EST Cloopen falls -12.1% - Cloopen is down -12.1%, or -53c to $3.83.

12:00 EST Ecovyst falls -13.0% - Ecovyst is down -13.0%, or -$1.39 to $9.29.

12:00 EST Ginkgo Bioworks rises 10.8% - Ginkgo Bioworks is up 10.8%, or $1.29 to $13.27.

11:46 EST NiSource general counsel Anne-Marie D'Angelo to depart - NiSource (NI) announced that Anne-Marie D'Angelo, executive vice president, general counsel and corporate secretary, is leaving NiSource to assume the position of Chief Legal and Government Affairs Officer at Molson Coors Beverage Company (TAP). As a result of Ms. D'Angelo's departure, the company has named Vice President and Deputy General Counsel Kim Cuccia as interim General Counsel, and has commenced a nationwide search for a replacement.

11:24 EST Xbox game 'Forza Horizon 5' draws over 10M players in first week - Microsoft's latest PC title and Xbox console exclusive "Forza Horizon 5" reached over 10M players in its launch week, marking the biggest first week in Xbox history and Xbox Game Pass, according to the Twitter account of the "Forza Horizon" franchise. Reference Link

10:46 EST BioMarin confirms FDA grants accelerated approval to Voxzogo - BioMarin Pharmaceutical announced that the U.S. Food and Drug Administration has granted accelerated approval to Voxzogo for Injection, indicated to increase linear growth in pediatric patients with achondroplasia five years of age and older with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies. To fulfill this post-marketing requirement, BioMarin intends to use the ongoing open-label extension studies compared to available natural history. Voxzogo is the first FDA approved treatment for children with achondroplasia, the company said.

10:27 EST Boeing down 4% to $218.17 after WSJ report on 787 production issues

10:04 EST AstraZeneca, Tempus enter collaboration for oncology therapeutics - Tempus announced a multi-year, strategic collaboration with AstraZeneca in which the two companies will work together to gather insights, discover novel drug targets, and aim to develop therapeutics for the broader oncology community. By combining the capabilities of a technology company with those of a biopharmaceutical company, the two companies hope to advance drug discovery and development, to more quickly deliver innovation to patients. The strategic collaboration aims to optimize Tempus' AI-enabled platform and vast repository of multimodal data to advance novel therapeutic programs in oncology on a global scale. Under the terms of the agreement, AstraZeneca will leverage Tempus' de-identified data and analytical tools across a broad range of capabilities. This collaboration combines Tempus' AI and machine learning capabilities for identifying novel insights with AstraZeneca's deep expertise in R&D to ultimately develop new therapeutic options for patients.

10:02 EST Canada approves Pfizer, BioNTech Covid vaccine for 5 to 11 year olds - Health Canada today authorized the use of the Pfizer-BioNTech Comirnaty Covid-19 vaccine in children 5 to 11 years of age. This is the first COVID-19 vaccine authorized in Canada for use in this age group. Health Canada has authorized a two-dose regimen of 10 micrograms to be administered three weeks apart, which is a lower dose than the 30 micrograms two-dose regimen authorized for people 12 years of age and older. Health Canada "has placed terms and conditions requiring Pfizer-BioNTech to continue providing information to Health Canada on the safety and efficacy of the vaccine in this younger age group."

10:01 EST Piper Sandler board authorizes share repurchase up to $150M - Piper Sandler announced that its board of directors has authorized the repurchase of up to $150 million of the company's outstanding common stock. The share repurchase program will be used as part of the company's capital allocation strategy, which includes returning capital to its shareholders, and to offset the dilutive effect of employee equity-based compensation. The authorization becomes effective on January 1, 2022. The company's previous $150 million repurchase authorization expires on December 31, 2021. The new $150 million authorization will expire on December 31, 2023. As of October 29, 2019, the company had 17,878,195 shares of common stock outstanding.

10:00 EST Farfetch falls -13.1% - Farfetch is down -13.1%, or -$5.95 to $39.64.

10:00 EST CNFinance rises 9.0% - CNFinance is up 9.0%, or 32c to $3.88.

10:00 EST UWM Holdings rises 24.3% - UWM Holdings is up 24.3%, or $1.34 to $6.86.

09:47 EST Ecovyst falls -9.6% - Ecovyst is down -9.6%, or -$1.02 to $9.65.

09:47 EST Farfetch falls -18.3% - Farfetch is down -18.3%, or -$8.33 to $37.26.

09:47 EST Natural Grocers rises 10.0% - Natural Grocers is up 10.0%, or $1.26 to $13.82.

09:34 EST Redbox acquires U.S. distribution rights to 'Assailant' - Redbox Entertainment, the original content division of Redbox, announced it has acquired U.S. distribution rights to the thriller film "Assailant." The film will premiere in 2022 and is expected to have a limited theatrical run and be available day-and-date On Demand. The deal was negotiated by Marc Danon of Redbox Entertainment with Karinne Behr CEO of MSR Media International that handled worldwide distribution rights for the film.

09:29 EST Simplicity Esports signs equipment loan to purchase 80 new PCs - Simplicity Esports and Gaming Company announced that it has signed an equipment loan that will be used to purchase 80 new PCs. The loan is secured by the PCs, has a 10% interest rate, and is payable in 60 monthly installments of principal and interest.

09:25 EST Jaguar Health announces topline results of HALT-D trial - Jaguar Health announced topline results of the third-party, investigator-initiated Phase 2 HALT-D trial evaluating crofelemer for the prevention of chemotherapy-induced diarrhea, or CID, in HER2-positive breast cancer patients being treated with trastuzumab, pertuzumab and a taxane. These therapies are known to cause CID in up to 80% of breast cancer patients, reaching grade 3 in 8%-12% of patients. Jaguar Health believes crofelemer is the only antidiarrheal medication under clinical investigation that specifically targets the underlying mechanism of CID. The study included 51 breast cancer patients randomly assigned to either crofelemer or control standard of care with no prophylactic antidiarrheal medications. Findings showed that the primary endpoint - the incidence of having diarrhea for two or more days - was not statistically different for the two groups since about 70% of patients had this outcome regardless of cycle or CID treatment group, which is consistent with the experience of CID in patients receiving these chemotherapy regimens. The crofelemer group demonstrated better outcomes compared to the control group for a number of key secondary endpoints: Lower incidence of grade 2 or higher-grade diarrhea for the crofelemer group compared to the control group during cycle 2, based on patient-reported outcomes: 9.0% vs. 33.3%. Lower incidence of grade 2 or higher-grade diarrhea for the crofelemer group compared to the control group during cycle 2, based on investigator assessments: 9.5% vs. 41.1%. No patients in the crofelemer group experienced grade 3 or grade 4 diarrhea during cycle 2 compared to 17.6% of patients in the control group, based on patient-reported outcomes.

09:17 EST WisdomTree expands global digital assets team - WisdomTree Investments announced the expansion of its global digital assets team. The team focuses on existing and new investment products, indexes and strategies that provide exposure to crypto assets, along with new blockchain-enabled products and services across global markets. With the recent additions, WisdomTree now has a dedicated team of twelve professionals across the U.S., U.K., and Ireland focused exclusively on technology, compliance, legal, product, marketing, research and education, related to digital assets, blockchain and decentralized finance. Included in the recent new hires is John Davidson, joining as WisdomTree's new Global Head of Financial Crimes, focused on anti-money laundering and regulatory compliance. Before joining WisdomTree, John held a similar title at E*TRADE and was a Managing Director at Morgan Stanley.

09:16 EST HUMBL appoints George Sharp as capital markets advisor - HUMBL announced that it has once again retained the consulting services of George Sharp as Capital Markets Advisor. Mr. Sharp will shepherd HUMBL through an imminent application with OTC Markets for an advancement to the OTCQB tier and then towards an application to the NASDAQ Stock Market. In furtherance of these milestones, the company will file audited financials with the SEC beginning with the yearend statement for 2021.

09:11 EST Forwardly arranges for $2M in non-dilutive debt financing - Forwardly announced that it has arranged for $2 million in debt financing from its CEO, George Sharp. Under the terms of the 12 month loan, Mr. Sharp shall be entitled to an interest rate of 8% APR. The loan is not subject to conversion into Forwardly stock. Proceeds from the loan will be used to immediately purchase 10 million shares of HUMBL through the partial exercise of a warrant the company holds to purchase up to 125 million warrant shares through December 2023 at $.20 per share. Forwardly will be unable to sell these shares until they are registered with the SEC, and the company has no intention of disposing of any stock at depreciated values.

09:10 EST T2 Biosystems enters exclusive distribution agreement in Taiwan - T2 Biosystems announced the execution of a territory exclusive distribution agreement in Taiwan. Under the terms of the agreement,T2 Biosystems will sell T2Dx Instruments, along with T2Bacteria, T2Candida and T2Resistance Panels through this distributor. The execution of this distribution agreement includes an initial purchase of three T2Dx Instruments and marks T2 Biosystems' third entry in the Asia-Pacific market during the last 30 days. T2 Biosystems and its new distribution partner are collaborating with the health authorities in Taiwan to gain regulatory approval and offer patients the highest quality sepsis care available.

09:07 EST Natera's Panorama SMART study results accepted for publication by AJOG - Natera announced that the first manuscript from the landmark SMART study has been accepted for publication by the American Journal of Obstetrics and Gynecology, AJOG. This publication describes the performance of the Panorama non-invasive prenatal test, NIPT, for common trisomies. SMART tested the performance of Panorama. The study also included the validation of a new artificial intelligence-based algorithm for Panorama called Panorama AI. The SMART study enrolled more than 20,000 patients over five years at 21 U.S. and international sites. All patients received Panorama as part of routine clinical care. The key results in this initial publication include: Panorama demonstrated 99% sensitivity and more than 99.5% specificity for trisomy 21 in a real-world setting, consistent with previously published studies; and Panorama AI maintained high sensitivity, detected additional cases of common aneuploidies, and significantly lowered the no-call rate to 1.5%, and to 0.6% after one redraw. "We're proud to have sponsored the SMART study, the largest prospective NIPT validation study ever performed, which focused on a general population cohort and used the gold standard of diagnostic testing for genetic truth," said Ramesh Hariharan, General Manager of Natera's Women's Health business. "This study demonstrates the excellent performance of SNP-based NIPT in a real-world setting, giving practicing physicians around the world greater confidence in screening their pregnant patients for common trisomies."

09:05 EST Roche announces European Commission approval of Gavreto as monotherapy - Roche announced that the European Commission has granted conditional marketing authorization for Gavreto as a monotherapy for the treatment of adults with rearranged during transfection, or RET, fusion-positive advanced non-small cell lung cancer, or NSCLC, not previously treated with a RET inhibitor. "Gavreto is the first and only precision medicine approved in the European Union for the first-line treatment of people with RET fusion-positive advanced NSCLC," the company stated.

09:02 EST Saks x The RealReal pop-up to open at Saks Fifth Avenue Brickell - The RealReal and Saks Fifth Avenue announced the upcoming opening of the Saks x The RealReal Pop-Up at Saks Brickell on Friday, Nov. 26. The innovative retail collaboration marks the first time a luxury retailer has offered a consignment office and resale shop inside of one of its stores. At the pop-up, shoppers will have one-on-one access to The RealReal's experts for complimentary valuations and consignment appointments. Additionally, customers will have the opportunity to shop rare watches, coveted pieces and one-of-a-kind jewelry they can't find at any other retail destination.

08:49 EST Omniq to acquire additional 26% of Dangot Computers - OMNIQ announced the acquisition of an additional 26% of Dangot Computers increasing OMNIQ's ownership to 77%. Dangot is a leader in providing state of the art technology enabling frictionless automated order processing & digital payment processing products for retail, fast food and parking, integrated working stations for physicians, drug delivery and blood tests, robotics for smart warehouses, point of sales and other innovative solutions. OMNIQ, notified the seller of the Partial Exercise of its Option according to the Stock Purchase Agreement, dated May 3, 2021. OMNIQ will pay for the additional 26% based on the Israeli Shekel currency valuation and is valued at approximately $4,136,000. The Company will not issue any equity in connection with the transaction. Closing of the exercise is expected on November 24, 2021. Consolidated OMNIQ and Dangot pro forma revenue for fiscal year 2020 amounts to approximately $91M. OMNIQ acquired 51% of Dangot ownership effective July 1st, 2021, with a 12 month option to acquire the remaining 49%, of which, the acquisition of 26% was provided as an official notice for immediate execution earlier this week, by omniQ. On November 2021, Dangot Computers Ltd was awarded with an approximate $2 Million order for Intelligent Healthcare Carts from Israel's Largest Health Maintenance Organization. On August 3, 2021, OMNIQ announced that Dangot will provide its self-service kiosks to Aroma Espresso Bar, the largest coffee chain in Israel with branches in the US, Canada and other countries. According to a Forbes article titled "Self-Order Kiosks Are Finally Having A Moment In The Fast Food Space", written by Alicia Kelso , it is predicted that the self-service kiosk market will reach $30.8 billion by 2024. Based on Pro Forma 2020 results, the acquisition creates a combined $91 Million revenue provider of automation and object identification solutions. OMNIQ is paying the sole shareholder of Dangot a total of approximately $4,136,000 million. OMNIQ will have an option to acquire the remaining 23% at the same Israeli Shekel valuation.

08:44 EST Samsung joins Via Licensing's MPEG-H 3D Audio licensing program - Via Licensing Corporation announced that Samsung has joined the company's MPEG-H 3D Audio patent pool as both a licensee and a licensor. Launched in June 2021, Via's pool enables innovators and implementors to license MPEG-H 3D Audio standard essential patents under fair and reasonable terms.

08:43 EST Pacira completes acquisition of Flexion Therapeutics - Pacira BioSciences (PCRX) announced the completion of its previously announced acquisition of Flexion Therapeutics (FLXN). "This is an exciting day for Pacira BioSciences as this acquisition expands our industry leadership and marks a major milestone in our strategy to build a robust offering of novel, non-opioid treatments to improve patient care along the neural pain pathway," said David Stack, Chief Executive Officer of Pacira. "ZILRETTA is a highly complementary commercial asset that allows us to provide physicians with another tool in their pain management armamentarium to tackle osteoarthritis earlier in the patient journey as we continue to redefine the role of opioids as a last resort rescue medication. Importantly, ZILRETTA will diversify our revenue stream, enhance our topline, and we believe it will provide meaningful synergies that we expect to drive substantial near- and long-term accretion to our cash flows and earnings."

08:40 EST Canopy Growth CFO Lee, CPO Kovacevic stepping down - Canopy Growth announced changes to its Executive Management Committee. Effective immediately, Mike Lee, Executive Vice President and Chief Financial Officer, CFO, and Rade Kovacevic, President and Chief Product Officer, CPO, will be stepping down from their respective roles on the Executive Management Committee and will depart from the company on December 31, 2021. In the interim, they will serve in an advisory capacity to support transition. The Company has initiated an external search for both roles and to support the transition has named Judy Hong as interim Chief Financial Officer and Tara Rozalowsky as interim Chief Product Officer. In addition to serving as members of the company's Executive Management Committee, both will report directly to CEO David Klein effective immediately.

08:40 EST Dermata Therapeutics announces efficacy, safety data from DMT410 trial - Dermata Therapeutics announced efficacy and safety data from its Phase 1b proof of concept study evaluating a single treatment of DMT410 to treat multiple aesthetic skin conditions. This data was presented at The American Society for Dermatologic Surgery. Global Aesthetic Improvement, or GAI, - the physician measured an improvement in patient's overall GAI at week 4 in 70% of patients, 80% of patients at week 8, and 60% of patients at week 12. GAI is measured on a 4-point scale, with at least a 1-point reduction being a 25% improvement. The mean improvement in GAI score from baseline was 0.8 at week 8. Pore size - the physician observed an improvement in pore size in 50% of patients at week 4, 60% of patients at week 8, and 50% of patients at week 12. An improvement in pore size is measured on a 4-point scale, with at least a 1-point reduction being a 25% decrease in pore size. The mean improvement in pore size from baseline was about 0.7 at week 8. Luminosity - the intensity of light area reflected on the skin, improved in 50% of patients at week 4, 90% of patients at week 8, and 90% of patients at week 12. The mean improvement of luminosity from baseline, on a scale of 0 to 10 points, peaked at 1.4 points of improvement at week 12. Brightness - a measurement of the combined uniformity of skin coloring and texture, improved in 30% of patients at week 4, 60% of patients at week 8, and 60% of patients at week 12. The mean improvement of brightness from baseline, on a scale of 0 to 10 points, peaked at 0.7 points of improvement at week 12. Upper facial lines - a measurement of the visible improvement of a patient's forehead, lateral canthal, and glabellar lines did not show clinically meaningful improvement. This result is consistent with the knowledge that botulinum toxin is only approved for injections into the muscle to treat these endpoints. In terms of safety and tolerability, DMT410 was generally safe and well tolerated with no adverse events reported, no withdrawals due to treatment-related adverse events, and no potential distant spread of toxin reported.

08:37 EST Activist Investing announces 9.9% ownership interest in Schmitt Industries Inc - Activist Investing announced the acquisition of approximately 9.9% of the outstanding shares of Schmitt Industries, Inc. David Elliot Lazar, CEO of Activist Investing, issued the following statement: "We are pleased to announce our significant investment in Schmitt given the meaningful opportunity we believe the Company represents and are eager to begin working with the Board of Directors and management to actively explore potential strategic options to drive shareholder value."

08:36 EST 22nd Century CFO John Franzino transitions to CAO, Richard Fitzgerald succeeds - 22nd Century Group (XXII) announced that Richard Fitzgerald has joined the Company as its CFO, effective November 15, 2021. John Franzino, the Company's previous CFO has transitioned to Chief Administrative Officer, where he will be responsible for further developing the company's business processes and leading the Company's financial planning and analysis, operational finance, human resources, and information technology functions. Previously, Fitzgerald was a consulting CFO for Atrin Pharmaceuticals, a novel DNA Damage Repair focused oncology platform, Co-Founder and CFO of SIRPant Immunotherapeutics and CFO of Immunome, where he helped lead the company's initial public offering onto the Nasdaq.

08:35 EST Blade to launch helicopter service between Manhattan, Newark Airport - Blade Air Mobility announced the expansion of its Blade Airport product with the launch of helicopter service between Manhattan and Newark Airport. Flights are available between 7am and 7pm Monday through Friday, and 3pm to 7pm on Sundays for $195 per seat or $95 per seat for Blade Airport passholders. Fliers will soon enjoy access to Blade's private terminal space at Newark, which is currently being developed adjacent to the airport helipad, pursuant to a long-term agreement with Signature Flight Support. The agreement with Signature, which runs through 2028, will enable Blade to provide a seamless and comfortable experience for fliers, improve flight turn-times and begin planning for the infrastructure requirements of Electric Vertical Aircraft, or EVA. The terminal will also serve to accommodate expected increases in passenger volumes as Blade introduces EVA service.

08:33 EST Telesat Holdings becomes public company - Telesat Corporation (TSAT) announced that it is now a public company and will begin trading on the Nasdaq Global Select Market and the Toronto Stock Exchange (under the ticker symbol "TSAT". This follows the closing of Telesat's previously announced transaction with Loral Space & Communications Inc. (LorL) and Public Sector Pension Investment Board, in which Loral's stockholders and Telesat Canada's other equityholders have exchanged their interests for equity in Telesat's new public holding structure. Telesat did not issue new equity to raise additional cash financing as part of the Transaction. Telesat Canada and Loral have become subsidiaries of Telesat Corporation, the Canadian controlled and incorporated public holding company formed in connection with the Transaction. Telesat Corporation will continue to be led by Telesat's President and Chief Executive Officer Dan Goldberg. In the Transaction, each share of Loral common stock has been converted into the right to receive either one share of Telesat Corporation or one unit of Telesat Partnership LP. PSP Investments and other shareholders of Telesat Canada have also exchanged their shares or equity awards into shares or equity awards of Telesat Corporation or units of Telesat Partnership. In total, Telesat Corporation and Telesat Partnership are expected to have 49,546,940 shares and units outstanding, of which a total of 11,907,246 Class A common shares and Class B variable voting shares of Telesat Corporation will be outstanding initially. The Class A common shares and Class B variable voting shares of Telesat Corporation are listed for trading on NASDAQ and TSX, under the stock symbol TSAT. The equity securities of Telesat Corporation and Telesat Partnership that are not listed for trading consist of Class C shares of Telesat Corporation and units of Telesat Partnership, which are convertible into Class A common shares and Class B variable voting shares of Telesat Corporation in accordance with their terms. Telesat's Board of Directors will have a majority of Canadian directors and will include current Telesat Canada board members Melanie Bernier, Michael Boychuk, Richard Fadden, Henry Intven, Dr. Mark H. Rachesky, Guthrie Stewart and Michael B. Targoff, along with new directors Jason A. Caloras, MHR Fund Management LLC Principal; Jane Craighead, Chartered Professional Accountant and former Scotiabank Senior Vice President, Global Human Resources; Dan Goldberg, Telesat President and CEO. Following the completion of the Transaction, affiliated funds of MHR Fund Management LLC hold securities representing approximately 36% of Telesat's outstanding equity, and PSP Investments beneficially holds securities representing approximately 37% of Telesat's outstanding equity.

08:31 EST Omron opens new Proof of Concept Center in Novi, Michigan - Omron Automation Americas has opened a new Proof of Concept Center, PoCC, in Novi, Michigan, where customers can "collaborate with application engineers and have access to the latest technologies to develop innovative automation solutions," the company said. The PoCC is a connected lab environment that offers real-world, hands-on application development, testing and technical training. The 6,000 square foot PoCC houses the latest industrial automation technologies, including robotics, artificial intelligence, machine control, advanced sensing and safety innovations. The PoCC also features a hands-on traceability experience where a guest can walk through a simulated manufacturing process to better understand the benefits of an advanced quality and traceability solution.

08:27 EST Pfizer, BioNTech receive expanded EUA for COVID-19 vaccine booster dose - Pfizer (PFE) and BioNTech (BNTX) announced that the FDA has expanded the emergency use authorization, or EUA, of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18 years of age and older. The booster dose is to be administered at least six months after completion of the primary series, and is the same dosage strength as the doses in the primary series.

08:22 EST Quotient announces equity awards - Quotient announced the scheduled grant of equity awards to Mr. Ali Kiboro, who has been appointed as the CFO of the Company effective November 1, 2021. In connection with his appointment, the Company granted Mr. Kiboro 203,491 performance-based restricted share units, 122,095 Restricted Share Units and share options to purchase 123,267 of the Company's ordinary shares. Such grants were issued outside of the Company's 2014 Stock Incentive Plan and were approved by the Company's Board of Directors and the Remuneration Committee of the Board of Directors pursuant to the inducement grant exception under the Nasdaq Rule 563(c)(4), as an inducement that is material to Mr. Kiboro joining the Company as the Chief Financial Officer. The Sign-On PSUs will vest on the third anniversary of the grant date, provided specific performance criteria have been met. These performance criteria include the Company achieving certain financial targets. The Sign-On RSUs will vest over three years, with 50% vesting on the first anniversary of the grant date, and 25% vesting on each of the second and third anniversaries of the grant date. The Sign-On Options will vest in three equal instalments on each of the first, second and third anniversaries of the grant date. The vesting of the awards will be subject to Mr. Kiboro's continued service with the Company on each applicable vesting date.

08:20 EST Bilibili prices offering of convertible senior notes - Bilibili announced the pricing of $1,400 million in aggregate principal amount of convertible senior notes due 2026. The Notes have been offered to persons reasonably believed to be qualified institutional buyers in reliance on the exemption from registration provided by Rule 144A under the Securities Act of 1933, as amended. In addition, the Company has granted the initial purchasers in the Notes Offering a 30-day option to purchase up to an additional $200 million principal amount of the Notes. When issued, the Notes will be senior, unsecured obligations of Bilibili. The Notes will mature on December 1, 2026, unless repurchased, redeemed or converted in accordance with their terms prior to such date. Holders may convert their Notes at their option at any time prior to the close of business on the fifth scheduled trading day immediately preceding the maturity date. The initial conversion rate of the Notes is 10.6419 American depositary shares of the Company per $1,000 principal amount of Notes, and is subject to adjustment upon the occurrence of certain events described below. Upon conversion, the Company will pay or deliver, as the case may be, cash, ADSs or a combination of cash and ADSs, at its election. Holders of the Notes may elect to receive Class Z ordinary shares in lieu of any ADSs deliverable upon conversion. The Company may redeem for cash all or any part of the Notes on or after December 1, 2024 if the last reported sale price of the ADSs has been at least 130% of the conversion price for the Notes then in effect for at least 20 trading days, whether or not consecutive, during any 30 consecutive trading day period preceding the date on which the Company provides notice of redemption. In addition, the Company may redeem for cash all but not part of the Notes at any time if less than 10% of the aggregate principal amount of Notes originally issued remains outstanding at such time. The Company may also redeem the Notes upon the occurrence of certain tax-related events. Holders of the Notes may require the Company to repurchase for cash all or part of their Notes in cash on December 1, 2024, or in the event of certain fundamental changes. In connection with certain corporate events or if the Company issues a notice of Optional Redemption, Cleanup Redemption or Tax Redemption, it will, under certain circumstances, increase the conversion rate for holders who elect to convert their Notes in connection with such corporate event or such Optional Redemption, Cleanup Redemption or Tax Redemption. The Notes will bear interest at a rate of 0.5% per year, payable semiannually in arrears on June 1 and December 1 of each year, beginning on June 1, 2022. The Company intends to use the net proceeds from the Notes Offering for the enrichment of content offerings, research and development, and general corporate purposes. The Company plans to use an equivalent amount of the net proceeds from the Notes Offering to finance or refinance, in whole or in part, one or more of its new or existing Eligible Projects pursuant to its Sustainable Finance Framework.

08:18 EST FluroTech provides update on Pandemic Response Platform efforts - FluroTech provided a progress update on its efforts to bring its Pandemic Response Platform to market. FluroTest has been developing its "Pandemic and Emerging Disease Defense Platform" since late January 2021. The Company has made significant progress in its research and development efforts during just this 10-month period. The Company has optimized its test protocol and is realizing a 30x to 40x improvement in all aspects of the process. The Company has recruited key advisors with deep experience in both specific technologies being deployed and commercialization of other diagnostic assays unrelated to COVID. Based on the results from the new protocol, the Company believes it is positioned to achieve a disruptive breakthrough in the development of its "point of entry /point of access" testing solution. Important breakthroughs include: Reduction of steps in sample processing - This resulted in an optimized sample processing protocol reducing time and complexity as well as the elimination of certain laboratory processing equipment in the testing system solution. Testing protocol simplification - The Company has made great strides in refining the type of instrumentation required to read processed test samples, further reducing the time necessary for each reading as well as reducing the capital cost of field-based instrumentation hardware by as much as 50%. Materials cost per test reduced - While initial estimates of the direct cost of each test to the Company would approximate US $ 5.00 to US $6.00, the Company's optimized protocol development efforts produced a cost estimate per test of less than $1.00, thus providing the Company with significant flexibility in pricing tests much lower to the consumer while still maintaining favorable gross profit margins. Platform solution cost per test improved - The optimization of sample processing and equipment necessary to process tests will lower the capital cost per platform by as much as 50%, thus making the platform solution more affordable to significantly more potential customers and enabling more frequent testing. The Company expects in 3 to 4 months it will complete test optimization, protocol development, and prepare to enter clinical trials.

08:16 EST A-Mark Precious Metals, JM Bullion unveil CyberMetals platform - A-Mark Precious Metals and its wholly owned subsidiary, JM Bullion will unveil its new CyberMetals platform during a virtual presentation hosted by D.A. Davidson on Tuesday, December 7, 2021. Following the event, the Company will make available a copy of the slide presentation in the Investor Relations section of its website. Leveraging the core strengths of A-Mark and JMB, CyberMetals is an innovative, online platform that digitizes large gold, silver and platinum bars and allows consumers to buy and sell fractional shares of these bars in a range of denominations. The platform will support both accumulation-type programs where customers acquire precious metals at pre-defined intervals, as well as more opportunistic purchase and sale transactions. This unique structure provides the lowest possible pricing spreads to customers, which is differentiated from existing programs in the industry that generally carry large pricing spreads for smaller valued transactions. Customers will be able to access the CyberMetals portal through an intuitive platform on desktop or mobile device, giving customers 24/7/365 access to buy, sell and monitor their portfolio. CyberMetals' customers will have the option to convert their digital holdings to fabricated precious metals products via an integrated redemption flow with JMB. These products may be designated for storage by the Company or shipped directly to the customer, a feature currently unavailable in the domestic Exchange Traded Fund marketplace. To fund purchases, customers will have a broad array of payment options, including credit/debit card, automated clearing house, bank wire, cryptocurrencies, and PayPal. CyberMetals, a special purpose entity, will store the precious metals at A-Mark's Las Vegas, Nevada depository, which is fully custodied, secured and insured. A-Mark will partner with its current security partner, Loomis, to manage the storage of the metals. A-Mark and JMB plan to start beta testing the CyberMetals marketplace in December 2021 with commercial release scheduled for February 2022.

08:14 EST Bolt Biotherapeutics appoints Brian O'Callaghan, Frank Lee to board - Bolt Biotherapeutics (BOLT) announced the appointments of Brian O'Callaghan and Frank Lee to the Board of Directors. With these additions, longtime Director Peter Moldt, Ph.D. is stepping down from the Board of Directors and current Director Jim Healy, M.D., Ph.D. will be assuming the role of Lead Independent Director. O'Callaghan currently serves as Chief Executive Officer at ObsEva SA (OBSV), a clinical-stage pharmaceutical company developing novel therapies to improve women's health. Lee currently serves as President and Chief Executive Officer of Forma Therapeutics (FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers.

08:12 EST ConnectOne Bancorp completes enrollment of CBP-307 Phase 2 trial - Connect Biopharma announced that it has completed full enrollment of the phase 2 clinical trial evaluating CBP-307 in adult patients with moderate-to-severe Ulcerative Colitis. This global, randomized, double-blind, placebo-controlled phase 2 clinical trial is being conducted at multiple sites, including in the U.S., to evaluate the efficacy and safety of CBP-307 in 134 subjects, where CBP-307 or placebo is expected to be administered to eligible adult subjects with moderate-to-severe UC for 12 weeks. Following this 12-week induction phase, responders to treatment are expected to be treated for a further 36 weeks in a double-blind manner, with non-responders expected to enter an open-label arm and be treated for an additional 36 weeks. All enrolled patients are expected to participate in a follow-up phase of 4 weeks following the end of the maintenance phase.

08:10 EST Moderna announces FDA extension of EUA for COVID-19 vaccine booster - Moderna announced that the FDA has extended the emergency use authorization of a booster dose of the Moderna COVID-19 vaccine at the 50 microgram dose level to all adults aged 18 and older. This booster can be used in all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine.

08:08 EST AbbVie's Allergan Aesthetics to present six abstracts at ASDS - Allergan Aesthetics, an AbbVie company, announced that it will present six abstracts from its portfolio of aesthetic treatments and products at the American Society for Dermatologic Surgery, ASDS. "Our science-based findings continue to help drive the advancement of aesthetic medicine; therefore, we highly value the opportunity to share our published data with the medical community," said Darin Messina, Senior Vice President, Allergan Aesthetics R&D. "We are honored that the congress is recognizing two BOTOX Cosmetic abstracts as 'Best of Cosmetic Oral Abstracts' and look forward to continuing scientific exchange at ASDS in years to come." Also being shared at ASDS, Arisa Ortiz, MD, FAAD, will present product information on Allergan Aesthetics SkinMedica TNS Advanced+ Serum.

08:07 EST Kyndryl, VMware expand partnership to accelerate IT, business modernization - Kyndryl (KD) and VMware ( VM) announced an expansion of the companies' strategic partnership focused on app modernization and multicloud services. The primary goal of the expanded partnership is to accelerate IT and business reinvention for customers through the combination of VMware solutions and Kyndryl's design, build and managed services. The companies also aim to help customers speed their digital transformations by building and deploying secure applications. Kyndryl also plans to work with VMware to expand its existing multicloud advisory, implementation, and management services to support the VMware Tanzu platform and deploy vSphere workloads to VMware multi-cloud infrastructure running in all public clouds. "Multicloud is the digital business model for the next 20 years. With the average organization running hundreds of apps across many different clouds, customers need solutions and strategic partners that enable their organizations to be as agile and resilient as possible. This is the power of the VMware and Kyndryl partnership," said Susan Nash, senior vice president, strategic corporate alliances, VMware. "Kyndryl is a strategic partner that brings world-class solutions, skills, expertise, and experience to the companies' mutual customers. Together, we will empower customers to achieve smarter paths to cloud, edge, and app modernization; provide autonomy for developers; and enable a more secure, frictionless distributed workforce."

08:05 EST Standard Lithium says Blue Orca report 'misunderstands' data reported to AOGC - The company sdaid, "Standard Lithium notes that the report misunderstands the scope of the data reported to the Arkansas Oil and Gas Commission. The Demonstration Plant operated by Standard Lithium, under normal conditions, continuously produces lithium chloride solution, which is then mixed back into the waste brine stream and reinjected back into the geological formation via Lanxess' existing brine disposal system. These large volumes of lithium chloride that were produced are not included in the data reported to the AOGC. To be clear, the only data reported to the AOGC, in compliance with the requirements of the AOGC, were those volumes of lithium chloride solution that were temporarily stored on Standard Lithium's site and these have no correlation with actual lithium recovery rates observed in the plant. A portion of this lithium chloride was sent off-site for conversion to lithium carbonate on four separate occasions when conversion work was scheduled. The reported data forms only a small portion of the total lithium chloride recovered in the process. Blue Orca Capital's interpretation of lithium recovery rates is incorrect and underestimates lithium extraction efficiencies. Similarly, the report's claims that recovery is reducing over time also misinterprets the AOGC data. Standard Lithium has only stored lithium chloride product on site when required and the periods when it is stored do not correlate with actual lithium recovery rates observed in the plant at the time. Points of clarity: The lithium chloride solution reported under the category "The output of lithium carbonate, lithium chloride, and lithium hydroxide" on the AOGC website only represents that portion of lithium chloride solution which was temporarily stored on site and not the much larger volume that is continuously reinjected back into the brine formation; The conclusions of the report prepared by Blue Orca Capital are incorrect and based on misinterpretation of the information and excludes the much large volumes of lithium chloride solution that was produced at the Demonstration Plant; and, Blue Orca Capital has opportunistically issued this report with partial and incomplete information and without consultation or clarification by the Company. Demonstration Plant The report also fundamentally misunderstands the necessity and purpose of the Demonstration Plant. The Demonstration Plant was designed to continuously process an input tail brine flow of 50 gallons per minute which is the equivalent of 100-150 tonnes per annum of lithium carbonate. One of the objectives of the Demonstration Plant to date has been to produce sufficient quantities of solid lithium carbonate product off-site, to validate that battery quality materials can be produced. It has never been the intent to store on-site all of the lithium chloride produced and then convert all of that to lithium carbonate product. The principal purpose of the plant is to optimize the process to allow for design and scale-up of a commercial plant in preparation for a feasibility study. The Company is confident in its lithium extraction technology and Demonstration Plant and will maintain its focus on executing its strategic plans and progressing towards definitive feasibility and commercialisation at the Lanxess facility. The Company will not be providing further comment on the report at this time."

08:04 EST Alaska Air launches first flights to Belize City from Seattle, Los Angeles - Alaska Airlines announces it began nonstop service to Belize City from Seattle and Los Angeles. Given the demand for flights to Belize and building on the prior announcement of seasonal service in the winter, Alaska intends to fly the Los Angeles-Belize City route year-round. "For nearly two decades the Belizean market has been on our radar. We're thrilled to now be inaugurating service from both Seattle and Los Angeles," said Brett Catlin, vice president of network and alliances at Alaska Airlines. "Belize offers terrific family-friendly, eco-conscious possibilities - from iconic islands to lush jungles and ancient sites. And it's closer than you might think: From L.A., it's only a five-hour flight, and from Seattle it's six hours."

08:03 EST Amneal gets FDA approval for difluprednate ophthalmic emulsion ANDA - Amneal Pharmaceuticals announced that it has received Abbreviated New Drug Application, or ANDA, approval from the FDA for difluprednate ophthalmic emulsion 0.05%, which is the generic version of Durezol and is used in the treatment of inflammation and pain associated with ocular surgery.

07:59 EST Brink's appoints Lindsay Blackwood as general counsel - The Brink's Company announced that Lindsay Blackwood has been promoted to executive vice president and general counsel effective immediately. Blackwood joined Brink's in 2012 as assistant general counsel and served in that role until 2020, when she was named vice president, associate general counsel. She has also served as corporate secretary since 2013.

07:36 EST BridgeBio, Helsinn Group enter strategic collaboration for GPX4 inhibitor - BridgeBio Pharma and Helsinn Group announced they have entered into a strategic collaboration to co-develop and co-commercialize a potentially first-in-class inhibitor designed to target glutathione peroxidase 4 with the hope of providing an effective new therapy for patients with difficult-to-treat tumors. The joint collaboration for BridgeBio's GPX4 inhibitor was established as part of a new non-exclusive collaboration framework between BridgeBio and Helsinn that allows the companies to propose co-development and co-commercialization opportunities for preclinical precision oncology programs Under the terms of the non-exclusive agreement, BridgeBio and Helsinn will have the option to collaborate on preclinical oncology programs that are identified from time to time by either party. The agreement is designed to magnify the ability of both companies to identify small oncology interventions that may have greater potential to help patients in combination with larger investigational therapies. For each program that the parties agree to pursue, they will share global development responsibilities under an agreed cost split. Helsinn will have exclusive manufacturing and commercial rights to the programs under the agreement, with BridgeBio receiving a profit share on U.S. sales and tiered royalties on ex-U.S. sales. The first program under the framework collaboration agreement that the parties will pursue is GPX4, a potentially first-in-class inhibitor that may be an effective new therapy for certain cancer patients. GPX4 is an enzyme that is often elevated in cancer tissue and associated with a worse prognosis for patients. GPX4 neutralizes toxic free radicals at the lipid membrane, protecting cells from death by ferroptosis. The GPX4 inhibitor is being developed to induce ferroptosis in cancer cells with the potential to impact approximately 500,000 patients in need of a therapeutic option. The safety and efficacy of GPX4 has not yet been established by any health authority world-wide. The non-exclusive framework agreement builds on an earlier global collaboration and licensing agreement that BridgeBio and Helsinn Group's affiliates, Helsinn Healthcare S.A. and Helsinn Therapeutics, Inc., entered into in March 2021. Under that agreement, Helsinn Therapeutics is jointly responsible for further development and commercialization activities for infigratinib, a small molecule kinase inhibitor of FGFR, in oncology and all other indications except for skeletal dysplasias in the United States and other regions, sharing profits and losses on an equal basis. This includes exclusive commercialization rights for infigratinib in Canada, where Health Canada recently approved TRUSELTIQ under the Notice of Compliance with Conditions policy, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement. Helsinn will fund the majority of ongoing and future research and development related to infigratinib in oncology in the foregoing territory. BridgeBio will be eligible for tiered royalties as a percentage of adjusted net sales, and potential payments totaling up to $2.45B in the aggregate. BridgeBio previously entered a strategic collaboration with LianBio for development and commercialization of infigratinib in oncology indications in China, Hong Kong and Macau.

07:31 EST PCS Edventures!.COM selected by Iowa Governor's STEM Advisory Council - PCS Edventures! announced that the company has been selected by the Iowa Governor's STEM Advisory Council to scale its Ready, Set, Drone! program for upper elementary and middle school students. Each year, Iowa invests $3M in high-quality STEM programming that reaches up to 100,000 learners in and out of school. PCS Edventures is one of the twelve program providers approved for the STEM Scale-Up menu for the 2022-2023 academic year. Educators who apply to participate in the spring of 2022 will receive materials and professional development training over the summer before beginning program implementation.

07:13 EST New Gold updates impact of weather in British Columba at New Afton Mine - New Gold provides an update on the impact of the heavy rains, flooding and mudslides experienced in British Columbia, which have disrupted the transportation routes to the company's New Afton Mine. To date, the flooding in British Columbia has had no material impact on New Afton's infrastructure and operations. "We will continue to monitor the situation closely and assess the impact of these events on New Afton and the implementation of mitigation measures. Any potential impact to production, sales, or costs at the New Afton Mine will depend on the duration of the disruption to the transportation routes," the company said.

07:12 EST Chimerix to present ONC201 data in recurrent H3 K27M-mutant DMG - Chimerix announced the presentation of data from its 50-patient efficacy analysis of ONC201 for the treatment of recurrent H3 K27M-mutant diffuse midline glioma. ONC201 is an orally administered small molecule dopamine receptor D2 antagonist and caseinolytic protease agonist for the treatment of recurrent gliomas that harbor the H3 K27M- mutation. These data will be presented by Isabel Arrillaga-Romany, MD, PhD, Director of Neuro-Oncology Clinical Trials, Massachusetts General Hospital Cancer Center tomorrow, November 20, 2021, during a plenary session at the Society for Neuro-Oncology Annual Meeting in Boston, MA. In addition, Dr. Arrillaga-Romany will join management for a conference call on Monday, November 22, 2021 to give an additional overview of the data. Key Data Highlights: ONC201 monotherapy exhibited durable and clinically meaningful efficacy in recurrent H3 K27M-mutant diffuse midline glioma patients: Response Assessment in Neuro-Oncology Criteria for High Grade Gliomas criteria assessed by dual reader blinded independent central review: Overall response rate: 20%; including one complete response; Median duration of response: 11.2 months; Median time to response: 8.3 months; Disease control rate: 40%; Progression-free survival: 35% at 6 months; 30% at 12 months. Response Assessment in Neuro-Oncology Criteria for Low Grade Gliomas criteria assessed by dual reader BICR; ORR 26%. Among evaluable patients, 46.7% achieved at least a 50% confirmed reduction in corticosteroid dose. Among evaluable patients, 20.6% achieved a confirmed improvement, indicative of improved quality of life. Overall survival: 12 months: 57%; 24 months: 35%. This cohort was comprised of the first 50 patients enrolled across five ONC201 clinical studies who met specific criteria based on feedback from the FDA. These patients were two years of age or older, had a measurable diffuse midline glioma with the H3 K27M- mutation, and had evidence of disease progression following prior therapy with at least radiation completed at least 90 days prior to enrollment.. One serious adverse event was attributed by an investigator as possibly related to ONC201. Full safety data collection and analysis for this cohort is ongoing. Prior safety review of ONC201 identified the most commonly reported adverse events as nausea/vomiting, fatigue and decreased lymphocyte counts. The U.S. Food and Drug Administration granted ONC201 Fast Track Designation for the treatment of adult recurrent H3 K27M-mutant HGG, Rare Pediatric Disease Designation for treatment of H3 K27M-mutant glioma, and Orphan Drug Designations for the treatment of glioblastoma and for the treatment of malignant glioma. Chimerix plans to meet with the FDA in 2022 following completion of ongoing chemistry, manufacturing and controls clinical pharmacology studies and natural disease history evaluation.

07:10 EST Castle Biosciences announces publication of DecisionDx-Melanoma data - Castle Biosciences announced the publication of a study of patients with stage I-III cutaneous melanoma. Data demonstrated that DecisionDx-Melanoma is a significant independent predictor of metastatic recurrence. DecisionDx-Melanoma is Castle's gene expression profile test that uses an individual patient's tumor biology to predict the risk of cutaneous melanoma metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors. The study, titled "The 31-gene expression profile stratifies recurrence and metastasis risk in patients with cutaneous melanoma," analyzed 438 patients who were tested with DecisionDx-Melanoma as part of their clinical care. The study's primary purpose was to show risk stratification by DecisionDx-Melanoma in patients with stage I-III cutaneous melanoma. A secondary end point was to demonstrate the added prognostic value of DecisionDx-Melanoma when combined with complete American Joint Committee on Cancer, or AJCC, staging or with SLN status alone, for recurrence detection. 438 patients with stage I-III melanoma consecutively tested with DecisionDx-Melanoma were analyzed and stratified as low risk, intermediate risk or high risk of recurrence or metastasis. DecisionDx-Melanoma significantly stratified five-year melanoma survival prognoses for patients, including recurrence-free survival, distant metastasis-free survival and melanoma-specific survival. Patients with a DecisionDx-Melanoma low-risk result had higher five-year survival outcomes and were less likely to experience a recurrence than patients with a high-risk result. Multivariable analysis showed that DecisionDx-Melanoma is a significant, independent predictor of metastatic recurrence. DecisionDx-Melanoma increased prognostic survival accuracy over sentinel lymph node status alone. Consistent with previous validation and performance studies, the study demonstrated that DecisionDx-Melanoma added independent prognostic value to current staging guidelines for cutaneous melanoma to identify patients with a high and low recurrence or metastasis risk to improve patient management.

07:07 EST Microbot Medical issued NOA for second patent for LIBERTY Robotic System - Microbot Medical announced that the United States Patent and Trade Office has issued a Notice of Allowance for a second patent application covering the Company's LIBERTY Robotic System. Globally, the Company now has 46 patents issued/allowed and 24 pending patent applications and is continuously submitting applications to protect its Intellectual Property. The allowed claims cover a modular robotic system for manipulation of at least two elongated, flexible surgical tools, the system including at least one unit operable to move a first tool and a base operable to move a second tool, wherein the base serves as a mounting for the units, and each unit communicates with the base in one of a mechanical coupling, electrical power supply and data communication.

07:06 EST Jeune Aesthetics to present pre-clinical data on KB303 in elastin production - Jeune Aesthetics announced the presentation of preclinical data supporting the ongoing development of KB303, an innovative, investigational gene-delivery therapy designed to enable local, full-length elastin production in the skin. The data will be presented at the American Society for Dermatologic Surgery 2021 Virtual Meeting to be held November 19-21, 2021. "The field of aesthetic medicine has been looking for a therapeutic approach that could increase the deposition of full-length elastic fibers in skin for decades," said Dr. Bhushan Hardas, President of Jeune Aesthetics. "Using our proprietary gene delivery platform, we've engineered KB303 to deliver the ELN gene and help cells naturally replenish elastin that has been lost due to photo-damage and aging. We're excited to present these first-ever data on KB303 that, while early, show promise in the potential to be the first approach to produce elastin to naturally improve skin elasticity." Title: KB303, An Innovative And Minimally Invasive HSV-1-Based Therapy to Improve Skin Elasticity: Cutaneous aging affects many layers of the skin, leading to wrinkling, atrophy of the dermis, and loss of elasticity associated with damage to the underlying elastin, a key extracellular matrix protein which provides resilience and elasticity to tissues and organs. Elastic fibers are key components of the skin's extracellular matrix, consisting of the protein elastin and microfibrillar proteins that assemble into long strands. Due to their low turnover rate, elastin fibers are particularly prone to the acc

07:04 EST Tilt Holdings receives approval for adult-use operations at Taunton facility - TILT Holdings announced that the Massachusetts Cannabis Control Commission has awarded a final adult-use cultivation, manufacturing and retail establishment licenses to Commonwealth Alternative Care's Taunton location. Retail and wholesale sales of adult-use cannabis will commence upon final inspection by the CCC. Operating since August 2018, CAC's Taunton facility includes a 100,000 square-foot cultivation and processing facility as well as a co-located dispensary. CAC produces and sells a wide range of flower, concentrate, edible and topical products for patients, customers, and industry partners throughout the state. The Taunton dispensary is located at 30 Mozzone Boulevard and is open daily from 9:30am to 7:30pm. This announcement follows the CCC's final approval for adult-use sales at CAC's Brockton location in October and its recent order authorizing CAC to commence operations at that location. CAC's locations in Brockton and Taunton together serve more than 8,000 patients in the greater Boston area.

07:00 EST Bristol-Myers announces new PDUFA date for mavacamten - Bristol Myers Squibb announced that the U.S. Food and Drug Administration has extended the review of the New Drug Application for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy to April 28, 2022. The FDA notified Bristol Myers Squibb on November 18, 2021 of the extension of the PDUFA date to allow sufficient time to review information pertaining to updates to the proposed Risk Evaluation Mitigation Strategy. A REMS program was included in the initial application for mavacamten. No additional data or studies have been requested.

06:49 EST Foot Locker expects global supply chain constraints to persist throughout Q4 - Andrew Page added, "We expect global supply chain constraints to persist throughout the fourth quarter; that said, we believe we are positioned for the holiday season, with positive momentum and inventory levels ready to meet customer demand."

06:38 EST Idacorp CFO Steven Keen to retire - IDACORP, Inc. and Idaho Power Company SVP and CFO Steven Keen has announced his intent to retire on October 1, 2022 after 40 years of service. He has been with Idaho Power since 1982 and has been the company's CFO since May 2014. The Board of Directors of IDACORP, Inc. and Idaho Power Company have appointed Brian Buckham to succeed Keen, effective March 1, 2022. After March 1, Keen will stay on as a senior vice president until he retires later in the year. Buckham has worked for Idaho Power since 2010, focused on areas such as securities law, capital markets, corporate governance, and risk management, among others, and was named SVP and General Counsel for Idaho Power and IDACORP in March 2017. When Buckham becomes CFO on March 1, Pat Harrington will become Vice President, General Counsel and maintain his role as Corporate Secretary. Harrington has served as the companies' Corporate Secretary since 2007.

06:34 EST Casa Systems to announce transformation toward software, cloud at Investor Day - Casa Systems will host its 2021 Virtual Investor Day. Key Event Highlights: Casa Systems is deploying a disruptive, end-to-end connected cloud solution to help customers generate new revenue from 5G, rural, and mobile private networks. Tens of billions of dollars will be spent to transform networks for 5G, rural and MPN. Long-Term Financial Outlook, Refinancing and Deleveraging Plans. "Casa is in the process of a multi-year transformation from a hardware-heavy to a software and cloud-centric company," said Jerry Guo, President and Chief Executive Officer of Casa Systems. "This is the result of years of product development that is now in the early stages of deployment. Software and cloud are where we see our biggest growth potential and it's where the largest percentage of our development and sales efforts are focused. We are excited to be recognized as an industry leader at such an important time in network transformation." Investor Day Agenda: Jerry Guo, Chief Executive Officer, will outline the Company's vision for a connected cloud with multiple cloud components deployed at data centers, service provider edge, and enterprise and consumer premises. Alf de Cardenas, Chief Customer Officer, will highlight how the Company is expanding to a broader base of customers and addressable market footprint as Casa Systems deploys its 5G, rural and MPN solutions. Steve Collins, Senior Vice President of Access Devices, will detail how the Company is creating a network capable of delivering innovative new features with extreme flexibility for private and public networks with open cloud-native designs. Gibson Ang, Vice President of Technology, will discuss the Company's 5G core and radio solutions. Peter Wolf, Vice President of Wireline Solutions, will explain how the Company is positioning new solutions for the cable market. Scott Bruckner, Chief Financial Officer, will address the Company's current and long-term financial position, including financial targets. As the result of executing on the Company's strategic priorities, Casa Systems anticipates it will deliver measurable performance improvements by fiscal 2025, including: At least 50 percent of revenue coming from software and cloud products. Return to 60 percent or greater gross margin. Gross profit to increase at a compound annual growth rate of no less than 10%.

06:31 EST BioNTech receives FDA fast track designation for BNT111 - BioNTech announced that the U.S. Food and Drug Administration granted Fast Track Designation for BNT111, an investigational cancer immunotherapy for the potential treatment of advanced melanoma. BNT111 is the lead product candidate from BioNTech's fully owned FixVac platform that utilizes a fixed combination of mRNA-encoded, tumor-associated antigens aiming to trigger a strong and precise immune response against cancer. The vaccine candidate is currently being investigated in a Phase 2 trial in patients with anti-PD-1-refractory/relapsed unresectable Stage III or IV melanoma. The ongoing randomized Phase 2 trial in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma investigates BNT111 in combination with Libtayo, an anti-PD-1 monoclonal antibody being co-developed by Regeneron and Sanofi. The BNT111-01 trial which is conducted in collaboration with Regeneron is enrolling a total of 180 patients into three treatment arms in the United States, the United Kingdom, Australia, Spain, Germany, Italy and Poland. This trial seeks to support initial data reported from the ongoing Phase 1 Lipo-MERIT monotherapy dose escalation trial that demonstrated a favorable safety profile and anti-tumor responses of BNT111 alone and in combination with immune checkpoint inhibitor therapy in patients with advanced melanoma.

06:10 EST UTStarcom director Wendong Zhang resigns - UTStarcom announced that Ms. Wendong Zhang resigned from the Company's Board of Directors effective November 16, 2021 to pursue other business interests. Ms. Zhang also served on various board committees, including the Audit Committee, the Compensation Committee, and the Nominating and Corporate Governance Committee. Following Ms. Zhang's resignation, Mr. Hao Zheng was appointed as a member of the Board, the Audit Committee, the Compensation Committee, and the Nominating and Corporate Governance Committee of the Board, effective November 17, 2021. Mr. Zheng is the designee of Beijing E-town International Investment Development Co, pursuant to the stockholders rights agreement entered into by and between the Company and BEIID on February 1, 2010.

06:07 EST Brooklyn ImmunoTherapeutics announces filing of registration statement - Brooklyn ImmunoTherapeutics announced that on November 18, 2021 it filed with the Securities and Exchange Commission a registration statement on Form S-1 relating to the proposed public offering by certain selling stockholders of up to 6,281,454 shares of Brooklyn's common stock received in connection with Brooklyn's acquisition of Novellus, Inc. in July 2021. Brooklyn will not receive any proceeds from any shares sold by the selling stockholders.

06:05 EST BioRestorative Therapies enters LOI with PRC Clinical - BioRestorative Therapies announced that it has entered into a letter of intent with PRC Clinical, a CRO specializing in clinical trial management, with regard to PRC Clinical providing startup clinical project management activities for the Company's BRTX-100 Phase 2 clinical trial to treat chronic lumbar disc disease.

06:03 EST Gracell receives fast track designation for GC012F from FDA - Gracell announced that the FDA has granted orphan drug designation for GC012F, Gracell's FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy for the treatment of multiple myeloma.

05:19 EST Reata Pharmaceuticals receives fast track designation for omaveloxolone from FDA - Reata Pharmaceuticals announced the FDA has granted fast track designation for omaveloxolone for the treatment of Friedreich's ataxia.

05:10 EST Fortuna Silver Mines provides update on appeal of denial order from SEMARNAT - Fortuna Silver Mines provided an update on the status of the appeal to the denial order received on November 10 from the Secretaria de Medio Ambiente y Recursos Naturales, or SEMARNAT, with respect to the application to extend the environmental impact authorization, or EIA, at the San Jose Mine, located in Oaxaca, Mexico. Fortuna's Mexican subsidiary, Compania Minera Cuzcatlan is working with its legal advisors to file an appeal to the Denial Order prior to the end of November. The appeal will be brought by Minera Cuzcatlan in the Mexican courts. The grounds for the appeal are that Minera Cuzcatlan is in full compliance with all material environmental laws, and therefore Minera Cuzcatlan has the right to an extension of the EIA under applicable law. The timing for a decision by the Administrative Court is uncertain, and Fortuna has been advised that such decisions may often take up to a year to be delivered. The San Jose mine is currently operating under the protection of the Mexican courts which allows the continued operation of the San Jose mine beyond the expiry date of the EIA. Under the terms of the company's credit facility, the company is required to obtain a permanent injunction or equivalent protection, in form and substance acceptable to the lenders acting reasonably, by November 20 to allow the company to continue to operate the San Jose mine from October 23. The lenders under the credit facility have agreed to waive that requirement until February 18, 2022, provided such permanent injunction or equivalent protection has not been lifted or stayed prior thereto. The company believes that it is fundamentally in compliance with all material aspects of the EIA and is entitled to an extension. The company is continuing to work with authorities to resolve this matter. Minera Cuzcatlan is continuing to pursue all legal protection available to it in order to continue to operate pending the appeal of the Denial Order.