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

AMD

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18:41 EDT AMD CEO: We're laser focused on technology leadership - In an interview on CNBC's Mad Money, Lisa Su said AMD currently has significant scale. "Everyone needs more computing, especially high end computing, and that is our sweet spot," she added. Billions of people are using AMD's technology, and she only sees that increasing going forward. The company is still extremely focused on the data center, but there are huge opportunities in AI, she noted. Su expects a down PC market in 2022 after two years of strength. AMD is generating a lot of cash and she expects that continue.
AMD

Hot Stocks

18:25 EDT AMD CEO: We're laser focused on technology leadership - In an interview on CNBC's Mad Money, Lisa Su said AMD currently has a significant scale. "Everyone needs more computing, especially high end computing, and that is our sweet spot," she added. Billions of people are using AMD's technology, and she only sees that increasing going forward. The company is still extremely focused on the data center, but there are huge opportunities in AI, she noted. Su expects a down PC market in 2022 after two years of strength. AMD is generating a lot of cash and she expects that continue.
MUDS

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18:00 EDT Mudrick Capital Acquisition Corp II trading resumes
MUDS

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17:42 EDT Blue Nile to go public via merger with Mudrick Capital Acquisition Corporation II - Blue Nile, an online retailer of GIA graded, conflict-free diamonds, diamond engagement rings, and fine jewelry, and Mudrick Capital Acquisition Corporation II, announced they have entered into a definitive agreement for a business combination that will result in Blue Nile becoming a public company. Upon closing of the transaction, the combined company will be named Blue Nile and is expected to be listed on NASDAQ. The post-combination company will be led by Sean Kell, Blue Nile's CEO, and the current management team. The transaction is anticipated to generate approximately $450M of capital before expenses, assuming no redemptions by the public stockholders of Mudrick Capital Acquisition Corporation II. This includes $50M of new preferred equity provided by Mudrick Capital. It also includes $80M of committed PIPE capital (~$50M of which has been pre-funded) from existing sponsors Bain Capital Private Equity, Bow Street, and Adama Partners, and from Mudrick Capital. Existing Blue Nile shareholders will roll over their existing equity, retaining 39% of the combined company's pro forma equity. The pro forma implied equity value of the combined company is $873M at the $10.15 per share PIPE price, assuming no redemptions by the public stockholders of Mudrick Capital Acquisition Corporation II. The transaction implies a pro forma enterprise value for Blue Nile of approximately $683M. The Boards of Directors of Blue Nile and Mudrick Capital Acquisition Corporation II have approved the transaction. The transaction, which will require the approval of Mudrick Capital Acquisition Corporation II stockholders, is subject to other customary closing conditions, including the receipt of certain regulatory approvals and a minimum cash condition. It is expected to close early in Q4.
LHCG UNH

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17:39 EDT LHC Group, UnitedHealth receive second request for information from FTC - As previously disclosed, on March 28, LHC Group(LHCG) entered into an Agreement and Plan of Merger with UnitedHealth Group Incorporated (UNH), pursuant to which UnitedHealth Group will acquire the company. The obligation of the parties to consummate the Merger is subject to, among other things, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, applicable to the Merger. As previously disclosed, on April 7, each of the company and UnitedHealth Group filed its respective notification and report form with the U.S. Department of Justice and the U.S. Federal Trade Commission under the HSR Act. As part of the parties' continuing cooperation with the Agencies and in order to provide the Agencies with additional time for review, on May 5, UnitedHealth Group, in consultation with the company, voluntarily withdrew its premerger notification and report form effective as of May 9, and then refiled the premerger notification and report form on May 11. On June 10, the company and UnitedHealth Group each received a request for additional information and documentary materials from the FTC in connection with the FTC's review of the Merger. The effect of the Second Request is to extend the waiting period imposed under the HSR Act until the 30th day after substantial compliance by the company and UnitedHealth Group with the Second Request, unless the waiting period is terminated earlier by the FTC or extended by the parties to the Merger. The parties have been working cooperatively with the FTC and will continue to do so.
GOOG...

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17:38 EDT Google says 'Resident Evil Village' cloud demo now available in browser - Google (GOOGL) said in a blog post yesterday that Immersive Stream for Games, Google's cloud gaming technology which powers both the company's Stadia gaming platform and publishers' ability to deliver games directly to their players, now supports Capcom (CCOEY) with the launch of a cloud demo for 2021 game "Resident Evil Village." More players than ever can now try the game in seconds on Capcom's website via their computer browser, compatible smartphone or tablet at no additional cost, Google said. Reference Link
MUDS

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17:32 EDT Mudrick Capital Acquisition Corp II trading halted, news dissemination
QS

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17:08 EDT QuantumScape CMO Mikolajczak to leave company - According to a regulatory filing, on June 6, 2022, Quantumscape and Celina Mikolajczak entered into a Separation Agreement and Release, pursuant to which the parties agreed to a mutual separation that will transition Mikolajczak from her full-time role as the company's Chief Manufacturing Officer to an advisory role on the company's Scientific Advisory Board. This transition is being made due to differing management styles between the parties, and as part of this change, the executives leading the company's manufacturing operations and supply chain teams will report directly to the CEO. Mikolajczak has informed the company that she intends to focus her career on the development of a fully U.S.-based battery supply chain.
AEM

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17:01 EDT Agnico Eagle urges shareholders to reject TRC Capital's mini-tender offer - Agnico Eagle Mines has been notified of an unsolicited mini-tender offer made by TRC Capital Investment to purchase up to 2M Agnico Eagle common shares, or approximately 0.44% of Agnico Eagle's outstanding common shares, at a price of C$64.00 per share. Agnico Eagle does not endorse this unsolicited offer, has no association with TRC Capital or its offer, and recommends that shareholders do not tender their shares to the offer. Agnico Eagle cautions shareholders that the mini-tender offer has been made at a price below the current market price for Agnico Eagle's shares. The offer represents a discount of approximately 4.51% and 4.68% to the closing price of Agnico Eagle's shares on the Toronto Stock Exchange and the New York Stock Exchange, respectively, on June 7, the last trading day before the mini-tender offer was commenced. The mini-tender offer is also subject to numerous conditions.
ZVO

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16:50 EDT Zovio files appeal in California case - Zovio announced it has filed a notice of appeal of the March 2022 decision of the Superior Court of the State of California, County of San Diego awarding statutory penalties in favor of the California Attorney General. Zovio said it is appealing because it believes the trial court's decision is flawed and the penalties ordered by the court are excessive. "The court's assessed penalty amounts were based on a questionable statistical extrapolation of a scant 126 phone calls from millions of calls that were made," the company said. "The court also failed to make any findings on Zovio's net worth, and we believe the penalties awarded are grossly disproportionate and excessive under both statutory and constitutional standards."
NAAS REDU

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16:40 EDT NaaS Technology Inc. announces completion of merger - NaaS Technology Inc. (NAAS) announced the successful completion of the transaction previously announced on February 8 between RISE Education Cayman Ltd (REDU), the company's predecessor, and Dada Auto Inc. As announced on April 29, the Transaction and certain additional Transaction-related proposals were approved by RISE's shareholders at an extraordinary general meeting held on April 29. The company, with its name changed to "NaaS Technology Inc.," continues to be listed on Nasdaq with its new ticker "NAAS." Yang Wang, a founder of NaaS, has been appointed the company's CEO and a director of the company. Lei Zhao, previously the CFO of NaaS, has been appointed the chief financial officer of the company.
OFLX

Hot Stocks

16:37 EDT Omega Flex raises quarterly dividend to 32c per share from 30c - Omega Flex announced that the Board of Directors declared a regular quarterly dividend of 32c per share payable on July 5, 2022, to shareholders of record on June 24, 2022. The new dividend is an increase from its previous quarterly dividend of 30c per share. Kevin R. Hoben, the company's chairman stated that: "The sustained growth of Omega Flex, Inc. recommended an increase in the regular quarterly dividend. As the Company emerges from this challenging time for the country and the economy, this increase is the best indication of our belief in the Company's ability to weather this storm." In determining the amount of future regular quarterly dividends, the Board will review the cash needs of the company, and based on results of operations, financial condition, capital expenditure plans, and consideration of possible acquisitions, as well as such other factors as the Board of Directors may consider relevant, determine on a quarterly basis the amount of a regular quarterly dividend.
BJ

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16:35 EDT BJ's Wholesale opens four new clubs in IN, OH, NJ, VA - BJ's Wholesale Club is continuing its expansion with the opening of four new clubs as the next phase of its 2022 development plans. BJ's brings a fresh approach to the wholesale club experience by offering members incredible value and convenience. The newest clubs will be in Noblesville, IN., New Albany, OH., Wayne, N.J., and Midlothian, V.A. "We've seen tremendous success in growing our footprint over the last several years, both in our core east coast communities as well as in new markets like the greater Detroit and Pittsburgh areas," said Bill Werner, executive vice president, strategy and development, BJ's Wholesale Club. "Our expansion into the greater Indianapolis and Columbus markets allows us to bring the value of our membership to these new communities we look forward to serving."
DECK

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16:35 EDT Deckers Brands COO David Lafitte to step down - David Lafitte will step down from his role as COO to accept another opportunity, effective June 24. The supply chain functions currently reporting to Lafitte will now report to the Chief Supply Chain Officer, with other functions transitioning to the appropriate leaders on Deckers' executive team.
TSLA ORCL

Hot Stocks

16:32 EDT Tesla says Larry Ellison to not seek board re-election - According to a regulatory filing, Tesla (TSLA) said that, this month, Oracle (ORCL) chairman Larry Ellison determined collectively with the Nominating and Corporate Governance Committee and the Board that he will not stand for re-election to the Board when his current term ends at the 2022 Annual Meeting. The Board currently expects to reduce the number of Board seats to seven upon the expiration of Ellison's term at the 2022 Annual Meeting, and therefore votes or proxies may not be submitted for the election of more than two board seats. The Board and the Nominating and Corporate Governance Committee will continue to frequently evaluate the optimal size and composition of the Board to allow it to operate nimbly and efficiently, while maintaining new ideas, expertise and experience among its membership.
DECK

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16:31 EDT Deckers Brands names Angela Ogbechie as Chief Supply Chain Officer - Deckers Brands announced the promotion of Angela Ogbechie to the newly created role of Chief Supply Chain Officer, effective June 24. Ogbechie has served in various operational roles at Deckers since 2008, most recently as SVP, Global Operations & Supply Chain Strategy. In her new role, Ogbechie will oversee all activities related to the global supply chain operations and logistics organization. She will become a member of the Executive Leadership Team, reporting directly to Dave Powers, CEO and President of Deckers Brands. Ogbechie's promotion follows David Lafitte's decision to step down from his role as COO to accept another opportunity, effective June 24. The supply chain functions currently reporting to Lafitte will now report to the Chief Supply Chain Officer, with other functions transitioning to the appropriate leaders on Deckers' executive team.
TSLA

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16:19 EDT Tesla files for 3-for-1 common stock split in form of dividend - According to a regulatory filing, Tesla filed an Authorized Shares Amendment for the purpose of facilitating a 3-for-1 split of its common stock in the form of a stock dividend. As of June 6, 2022, we have 1,036,390,569 shares of common stock outstanding, and the current number of authorized shares of Tesla's common stock is 2,000,000,000, which is insufficient to effectuate the Stock Split. The company's Board intends to approve the Stock Split, subject to and contingent upon stockholder approval of the Authorized Shares Amendment.
LAX

Hot Stocks

16:19 EDT 8i Acquisition 2, EUDA Health amend share purchase agreement - 8i Acquisition 2 Corp. and EUDA Health announced an amendment to the Share Purchase Agreement to, among other things, reduce the consideration payable by LAX to EUDA Health, and limit the earn-out payment available to the seller of EUDA Health in connection with the Share Purchase. As previously announced, LAX entered into the Share Purchase Agreement dated April 11, with EUDA Health, Watermark Developments Limited, a British Virgin Islands business company, and Kwong Yeow Liew, acting as Representative of the Indemnified Parties. Pursuant to the terms of the SPA, a business combination between LAX and EUDA Health will be effected through the purchase by LAX of all the issued and outstanding shares of EUDA Health from the Seller. EUDA Health has revised its financial projections for 2022 to 2026 to account for the delays caused by the ongoing COVID-19 restrictions in some overseas markets, such as Indonesia and India, where EUDA Health has plans to expand into from 2022 to 2026. EUDA Health estimates that these restrictions would cause a delay of between twelve to twenty-four months in the commercial launch of EUDA Health's services in these markets. In the revised projections, the Singapore market is set as the core market in determining the valuation of EUDA Health, and its regional expansion plan has been excluded even though EUDA Health is currently actively continuing its regional expansion plan particularly in Indonesia and India. LAX and EUDA Health have agreed to revised transaction terms resulting in a pro forma enterprise value for the combined company of $172N by issuing 14 million new LAX ordinary shares for 100% of EUDA Health and an earn out of up to 4M LAX ordinary shares before December 31, 2024.
RMO

Hot Stocks

16:16 EDT Romeo Power receives NYSE notice of non-compliance - Romeo Power announced that it received a letter from the New York Stock Exchange indicating that the company is not in compliance with the NYSE continued listing standard as set forth in Section 802.01C of the NYSE Listed Company Manual. The Letter does not result in the immediate delisting of Romeo Power's common stock from the NYSE.
SJM

Hot Stocks

16:15 EDT J.M. Smucker to resume manufacturing Jif products at Lexington plant - According to a regulatory filing, on June 10, 2022, J.M. Smucker announced that it plans to resume manufacturing Jif peanut butter products at its Lexington Facility immediately. The company's Memphis, Tennessee facility was not affected by the recall and has continued to manufacture Jif peanut butter products. However, the company temporarily paused shipments from the Memphis Facility to eliminate confusion while customers cleared their shelves of potentially impacted products manufactured at the Lexington Facility. The company will resume shipping from the Memphis Facility and the Lexington Facility and is partnering with retailers to restock Jif products as soon as possible.
VRTS

Hot Stocks

16:05 EDT Virtus Investment reports preliminary AUM $167.2B as of May 31 - In addition, the company provided services to $3.2B of other fee-earning assets, which are not included in assets under management.
PETZ

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16:00 EDT TDH Holdings announces 1-for-20 reverse stock split - TDH Holdings announced that the Company's Board approved to effect a reverse stock split of the Company's common shares at the ratio of one-for-twenty with the market effective date of June 14, 2022. The objective of the reverse stock split is to enable the Company to regain compliance with NASDAQ Marketplace Rule 5550(a)(2) and maintain its listing on Nasdaq. Beginning with the opening of trading on June 14, 2022, the Company's common shares will trade on the NASDAQ Capital Market on a split-adjusted basis, under the same symbol "PETZ" but under a new CUSIP Number, G87084110. As a result of the reverse stock split, each twenty common shares outstanding will automatically combine and convert to one issued and outstanding common share without any action on the part of the shareholder. No fractional shares will be issued because of the reverse stock split. Instead, any fractional shares that would have resulted from the reverse split will be rounded up to the next whole number. The reverse stock split will reduce the number of common shares issued and outstanding from approximately 126,260,157 to approximately 6,313,014. The authorized number of common shares will be reduced by the same one-for-twenty ratio from 1,000,000,000 to 50,000,000.
BLUE

Hot Stocks

15:23 EDT Bluebird Bio confirms 13-0 FDA panel vote in favor of beti-cel - Bluebird Bio announced the outcome of the Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee discussion of betibeglogene autotemcel, or beti-cel, for the treatment of people with beta-thalassemia who require regular red blood cell transfusions. On the question "Do the benefits of beti-cel outweigh the risks for the treatment of subjects with transfusion-dependent beta-thalassemia?" the panel voted 13 yes to zero no. The advisory committee's recommendation is based on the Biologics License Application currently under priority review by the FDA with a decision goal date set for August 19. "Today's advisory committee recommendation is recognition of the substantial body of clinical data that support beti-cel as a potentially curative treatment option for these patients. We are grateful to the members of the beta-thalassemia community who contributed to today's discussion and remain committed to working with the FDA as it completes its review of the beti-cel Biologics License Application," said Bluebird CEO Andrew Obenshain. On June 9, the FDA panel unanimously endorsed eli-cel, an investigational gene therapy for the treatment of cerebral drenoleukodystrophy, in a 15 to 0 vote.
CSSE

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15:05 EDT Chicken Soup for the Soul Entertainment trading resumes
CSSE

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15:02 EDT Chicken Soup for the Soul halted for volatility after rising 18% to $8.63
CSSE

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15:00 EDT Chicken Soup for the Soul Entertainment trading halted, volatility trading pause
BLUE

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14:59 EDT FDA panel backs Bluebird's beti-cel for beta-thalassemia in 13-0 vote - An FDA panel voted 13-0 that the benefits of Bluebird Bio's betibeglogene autotemcel outweigh the risks for the treatment of subjects with transfusion-dependent beta-thalassemia. Yesterday, the FDA panel voted 15-0 that the benefits of Bluebird's elivaldogene autotemcel outweigh the risks for the treatment of any sub-population of children with early active cerebral adrenoleukodystrophy. The shares remain halted.
REV

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14:31 EDT Revlon halted again for volatility with shares down 42% to $2.52
REV

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14:24 EDT Revlon extends decline, shares now down 50% to $2.16
REV

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14:23 EDT Revlon sinks after Reorg says Chapter 11 may come next week - Shares of Revlon moved lower after Reorg's Harvard Zhang reported via Twitter that the company is preparing to file Chapter 11 bankruptcy as soon as next week, according to sources. Shares of Revlon are down 47% to $2.31 in afternoon trading.
REV

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14:19 EDT Revlon falls 42% to $2.53 after halting for volatility
WBS

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13:20 EDT Webster appoints Vikram Nafde to EVP, CIO - Webster Financial announced that Vikram Nafde has been appointed to EVP, Chief Information Officer in charge of Information Technology. As a member of Webster Bank's Executive Management Committee, Vikram is responsible for the strategy and execution of all Webster technology, including cybersecurity, data strategy and tech innovation. Nafde joined Webster in 2020 as SVP, Head of Software Engineering, Digital Delivery and Agility, shaping and leading all aspects of the Bank's software development and the rollout of the Scaled Agile operating model.
MGI

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13:17 EDT MoneyGram launches crypto-to-cash service on Stellar Network - MoneyGram and the Stellar Development Foundation announced the initial roll-out of a first-of-its-kind global on/off-ramp service for digital wallets to increase the utility of digital assets by creating a bridge between cash and cryptocurrencies. The service, a result of the partnership between MoneyGram and SDF announced in October 2021, is now available in a number of key remittance markets, including Canada, Kenya, Philippines and the U.S. for the first wave of users, with global cash-out functionality expected to be available by the end of June 2022. Powered by the Stellar blockchain and Stellar-enabled digital wallets, MoneyGram's retail agent network, and Circle's USD Coin, a fully-reserved dollar digital currency, the service provides cash users access to the world of cryptocurrency via any participating MoneyGram location. This service is a monumental step towards bridging the gap between physical and digital currencies in a way that has not been done before at scale. As it develops, this solution will pave the way for blockchain technology to further financial inclusion, creating fluidity between cash and crypto so more people can benefit from the digital economy. To support adoption, MoneyGram will offer this as a zero-fee service for the first 12 months.
REDU

Hot Stocks

13:15 EDT RISE Education Cayman trading resumes
DRTS

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13:05 EDT Healthcare Capital Corp trading resumes
BKR

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13:01 EDT Baker Hughes reports U.S. rig count up 6 to 733 rigs - Baker Hughes reports that the U.S. rig count is up 6 from last week to 733 with oil rigs up 6 to 580, gas rigs unchanged at 151 and miscellaneous rigs unchanged at 2. The U.S. Rig Count is up 272 rigs from last year's count of 461 with oil rigs up 215, gas rigs up 55 and miscellaneous rigs up 2. The U.S. Offshore Rig Count is down 1 to 15, up 2 year-over-year. The Canada Rig Count is up 24 from last week to 141, with oil rigs up 22 to 94, gas rigs up 2 to 47. The Canada Rig Count is up 48 rigs from last year's count of 93, with oil rigs up 35, gas rigs up 13.
BKR

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13:01 EDT Baker Hughes reports U.S. rig count up 6 to 733 rigs
DRTS

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13:00 EDT Healthcare Capital Corp trading halted, volatility trading pause
REDU

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12:35 EDT Rise Education expects Dada Auto merger to close today - RISE Education Cayman announced that it expects to close the merger between RISE and Dada Auto Inc. previously announced on February 8, 2022 after the close of trading hours for the Nasdaq Stock Market later today. As a result of the Transaction, RISE will change its corporate name to "NaaS Technology Inc." and its ticker to "NAAS." The number of the Company's shares represented by each American Depositary Share will also be changed from two shares per ADS to ten shares per ADS, which will have the same effect as a one-for-five reverse split on the existing ADSs. The CUSIP of the Company's ADSs will be changed to 62955X102. The ISIN of the Company's ADSs will be changed to US62955X1028. All of the aforementioned changes will be effective prior to 4:00 A.M. on June 13, 2022. The ADSs of the Company are expected to start trading under the new name and ticker at 4:00 A.M. on June 13, 2022.
BNKU

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12:00 EDT Bank United Corporation falls -12.6% - Bank United Corporation is down -12.6%, or -$3.47 to $24.16.
VVNT

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12:00 EDT Vivint Smart Home falls -14.8% - Vivint Smart Home is down -14.8%, or -80c to $4.58.
WE

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12:00 EDT WeWork falls -15.4% - WeWork is down -15.4%, or -$1.11 to $6.09.
SOXS

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12:00 EDT Direxion Daily Semiconductor Bear 3X Shares rises 9.9% - Direxion Daily Semiconductor Bear 3X Shares is up 9.9%, or $4.62 to $51.09.
FAZ

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12:00 EDT Direxion Financial Bear 3x rises 10.3% - Direxion Financial Bear 3x is up 10.3%, or $2.55 to $27.25.
LABD

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12:00 EDT Daily S&P Biotech Bear 3x Shares rises 13.8% - Daily S&P Biotech Bear 3x Shares is up 13.8%, or $6.99 to $57.68.
JCSE

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11:27 EDT JE Cleantech Holdings Ltd trading resumes
JCSE

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11:22 EDT JE Cleantech Holdings Ltd trading halted, volatility trading pause
VRTX

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11:03 EDT Vertex Pharmaceuticals to present data on treatment with CFTR modulators - Vertex Pharmaceuticals announced that five scientific abstracts on the company's portfolio of cystic fibrosis medicines will be presented at the European Cystic Fibrosis Society's 45th European Cystic Fibrosis Conference held June 8-11, 2022, in Rotterdam, the Netherlands. Vertex will present the first analysis of data collected in the U.S. CF Foundation Patient Registry of over 16,000 people with CF treated with TRIKAFTA for an average of nine months. This first interim analysis of an ongoing five-year post-authorization study showed that real-world treatment with TRIKAFTA was associated with improved lung function and a 77% reduced risk of pulmonary exacerbations compared to pre-TRIKAFTA baseline, as well as an 87% lower risk of lung transplant and a 74% lower risk of death, compared to the historical 2019 U.S. CFFPR population. No new safety concerns were identified. Vertex will also present data comparing the annual rate of lung function change in people with CF ages 12 years and older with two F508del mutations or one F508del mutation and one minimal function mutation treated with TRIKAFTA in pivotal studies and an open-label extension study compared to propensity-score matched historical CFTR-modulator-untreated controls from the U.S. CFFPR. Results show that TRIKAFTA demonstrated on average no decrease in ppFEV1 over a two-year period in this population, in contrast to declines seen in the matched controls. The analysis indicates that treatment with TRIKAFTA has a significant impact on the trajectory of CF lung disease. Additionally, Vertex will present data from a long-term real-world study demonstrating that initiating KALYDECO early in life preserves lung function to a greater extent than if KALYDECO is initiated at an older age. These results show the importance of early initiation of KALYDECO for eligible patients.
AFMD

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10:35 EDT Affimed presents preclinical data on AFM28 - Affimed presented a poster at the Annual Meeting of the European Hematology Association in Vienna, Austria. The data demonstrate the cytotoxic potential of the CD123/CD16A-targeting bispecific innate cell engager AFM28 which is in development as a novel treatment for patients with myeloid diseases, e. g. relapsed/refractory acute myeloid leukemia. AFM28 binds to natural killer cells and CD123-positive tumor cells and demonstrated the induction of tumor cell killing in vitro and a good tolerability and strong anti-tumor activity in vivo. The data presented at EHA provide validation of the mechanism of action as well as preclinical proof-of-concept for AFM28 in a range of in vitro and in vivo assays. AFM28 exhibited high-affinity binding to CD16A expressed on NK cells and high avidity conferring long cell surface retention in comparison to Fc-enhanced anti-CD123 antibody. Moreover, AFM28 demonstrated the ability to destroy CD123-positive tumor cell lines and primary leukemic cells via antibody-dependent cell-mediated cytotoxicity. Importantly, AFM28 was active irrespective of mutational status of tumor cells and also induced depletion when CD123 expression was very low. Strikingly, AFM28 was also active against cells not killed by an Fc-enhanced CD123-targeting comparator antibody suggesting the potential for improved clinical effectiveness. Moreover, AFM28 also depleted leukemic cells from patient bone marrow without destroying CD34-positive/CD123-negative cells, suggesting sparing of hematopoietic stem and progenitor cells. In vivo studies in an AML murine model demonstrated anti-tumor efficacy, and cynomolgus toxicology models predicted pharmacodynamic activity with a well-tolerated safety profile and low risk of cytokine release syndrome. Efficient depletion of leukemic blasts and leukemic stem cells is critical for inducing long-term remission in AML patients. As both cell types express CD123, AFM28's ability to redirect NK cells to this target killing both leukemic blasts and leukemic stem cells makes this an attractive treatment strategy. Currently, there are no curative immunotherapies available, the only option is allogenic hematopoietic stem cell transplantation. Affimed plans to initiate clinical development of AFM28 with a first-in-human phase 1 monotherapy trial in adult patients with R/R AML in the second half of 2022. In addition, Affimed plans to investigate AFM28 in combination with allogeneic NK cell therapy after a safe starting dose has been determined.
AGIO

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10:33 EDT Agios Pharmaceuticals presents clinical data on benefits of PYRUKYND - Agios Pharmaceuticals reported new data further underscoring the significant burden of disease in adults with pyruvate kinase deficiency regardless of genotype and supporting the potential benefits of treatment with PYRUKYND for these patients. Data are being presented at the European Hematology Association Annual Congress, hosted virtually and in person in Vienna on June 9-12, 2022. PYRUKYND was approved in February 2022 by the U.S. Food and Drug Administration for the treatment of hemolytic anemia in adults with PK deficiency. PYRUKYND is also under review by the European Medicines Agency as a potential treatment for adults with PK deficiency, and Agios expects a regulatory decision in the EU by the end of 2022. Both the FDA and EMA have granted orphan drug designation to PYRUKYND in PK deficiency. Long-term Treatment with Oral Mitapivat Is Associated with Normalization of Hemoglobin Levels in Patients with Pyruvate Kinase Deficiency: This analysis of data from the Phase 3 ACTIVATE study and the ongoing long-term extension study assessed the proportion of patients who achieved normal hemoglobin levels, as defined by central and local laboratory manuals, at least once while receiving PYRUKYND without requiring any transfusions. Data demonstrate that treatment with PYRUKYND was associated with normalization of hemoglobin levels. A greater proportion of patients achieved normalization of hemoglobin levels among the subset who met the primary endpoint as hemoglobin responders, defined as a hemoglobin increase of greater than or equal to1.5 g/dL at greater than or equal to2 scheduled assessments at weeks 16, 20 and 24 during the fixed-dose period. As of the September 21, 2021 data cut-off, 40/40 patients in the mitapivat arm and 38/40 patients in the placebo crossover arm continued treatment in the extension study. Results were as follows: Across the ACTIVATE and extension studies, 28/78 of all patients achieved a normal hemoglobin level at least once during treatment with PYRUKYND; Among hemoglobin endpoint responders, 26/31 achieved a normal hemoglobin level at least once while receiving treatment with mitapivat; The majority of patients who achieved a normal hemoglobin level at least once in the ACTIVATE and extension studies achieved their first normal hemoglobin level within four months of treatment with PYRUKYND. Improvements in Patient-Reported Outcomes in Mitapivat-treated Patients with Pyruvate Kinase Deficiency: A Descriptive Analysis from the Phase 3 ACTIVATE Trial: The purpose of this post-hoc analysis of the ACTIVATE Phase 3 study was to describe the changes in patient-reported outcomes for the subset of patients who achieved the primary endpoint of hemoglobin response. Measurements were taken using two disease-specific PRO instruments: the PK deficiency diary and the PK deficiency impact assessment. As previously reported, PYRUKYND-treated patients in the ACTIVATE study demonstrated significant improvements in signs, symptoms and impacts based on these PRO instruments compared with patients receiving placebo. This analysis further revealed that improvements were greater in the patients who met the primary endpoint of hemoglobin response and sustained over time. Comorbidities and Complications Across Genotypes in Adult Patients with Pyruvate Kinase Deficiency: Analysis from the Peak Registry: This analysis of the Peak Registry, a global retrospective and prospective observational study of adult and pediatric patients diagnosed with PK deficiency, was designed to characterize comorbidities and complications across genotypes in adult patients. The analysis demonstrates that adult patients experienced a wide range of serious comorbidities and complications across multiple systems, regardless of PKLR genotype. In addition, these data highlight the existence of multiple complications in individual patients with PK deficiency and the need for appropriate monitoring and management of these patients, regardless of genotype.
UPH

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10:24 EDT UpHealth stockholders urge other stockholders not to return white proxy card - Jeffery Bray, Dr. Mariya Pylypiv, Syed Sabahat Azim, Richa Sana Azim, Dr. Azfar Malik, Alfonso Gatmaitan, Dr. Chirinjeev Kathuria and other stockholders announced today they issued an open letter urging stockholders of UpHealth to STOP, LOOK and LISTEN before taking any action in response to the Company's solicitation of proxies for the 2022 Annual Meeting of Stockholders set for 9:00 a.m. Pacific Time, on Tuesday, June 28, 2022. The stockholders said, "The UpHealth Concerned Stockholders strongly urge stockholders NOT to return the white proxy card or voting instruction form from the Company and NOT to allow the Company to take their vote over the telephone or by internet, but to wait until they receive and review the UpHealth Concerned Stockholders' definitive proxy materials and BLUE proxy card, which will be sent to UpHealth stockholders soon, before voting. If UpHealth stockholders have already voted the Company's white proxy card or voting instruction form or had their vote taken by the Company over the telephone or by internet, a later-dated BLUE proxy card will revoke their previously cast vote. When the UpHealth Concerned Stockholders' proxy solicitation materials are available, they will be seeking the vote of UpHealth stockholders because they believe that the Company needs to act now in order to restore stockholder value and do not believe that the Board, as currently constituted, and as currently proposed by the Board to be constituted following the Annual Meeting, is in the best position to achieve that objective. The Board has proposed a slate of three existing directors, adding no new viewpoints or expertise. The UpHealth Concerned Stockholders intend to solicit proxies from UpHealth stockholders to (permit them to withhold the voting of their shares at the Annual Meeting to prevent the Annual Meeting from being held until a Special Meeting of Stockholders can be held to amend the Bylaws to allow them to nominate a slate of three highly qualified independent directors and then vote those shares to elect those director nominees who the UpHealth Concerned Stockholders believe will help to enhance the value of the Company and better align the Board with the objectives of its stockholders."
PPG

Hot Stocks

10:18 EDT PPG sees $150M in acquisition synergies, up 15% from original goal - PPG said it highlighted its "growth through recent acquisitions," including Tikkurila, and its latest environmental, social and governance initiatives and goals at its investor day in Helsinki, Finland, on June 9. "Acquisitions are a key to PPG's long-term growth strategy and continue to create value for the company. We are pleased with the integration pace of our five most recent acquisitions," said Tim Knavish, PPG Chief Operating Officer. "Since we completed the acquisitions, we have identified further opportunities to drive our total synergy target to $150 million - a 15% increase from the original goal." The company added, "We have made great progress towards our 2025 targets, which include the goal of 40% of our sales from sustainably advantaged products. We are leveraging capabilities to continue to drive innovation and new product development toward more sustainable solutions, which will enable our customers' ability to meet their sustainability commitments and targets."
SNTI

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10:13 EDT Senti Biosciences Inc trading resumes
SNTI

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10:03 EDT Senti Biosciences Inc trading halted, volatility trading pause
IZEA RBLX

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10:02 EDT Izea awarded $2.8M contract by global Fortune 20 technology company - IZEA Worldwide (IZEA) announced that it has been awarded a $2.8M contract expansion by a global Fortune 20 technology company. IZEA has been contracted to execute a metaverse influencer activation inside Roblox (RBLX), with supporting activations on traditional social media platforms, including Instagram and TikTok, as well as appearances IRL.
FRGE

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10:00 EDT Forge Global falls -8.6% - Forge Global is down -8.6%, or -93c to $9.83.
ARIS

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10:00 EDT Aris Water Solutions falls -11.0% - Aris Water Solutions is down -11.0%, or -$2.33 to $18.82.
CDRE

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10:00 EDT Cadre falls -11.1% - Cadre is down -11.1%, or -$2.74 to $21.89.
KOLD

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10:00 EDT ProShares UltraShort Bloomberg Natural Gas rises 5.9% - ProShares UltraShort Bloomberg Natural Gas is up 5.9%, or $1.12 to $20.16.
LABD

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10:00 EDT Daily S&P Biotech Bear 3x Shares rises 7.0% - Daily S&P Biotech Bear 3x Shares is up 7.0%, or $3.53 to $54.22.
EDU

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10:00 EDT New Oriental Education rises 14.9% - New Oriental Education is up 14.9%, or $2.19 to $16.91.
USER

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09:47 EDT UserTesting falls -8.4% - UserTesting is down -8.4%, or -42c to $4.60.
CDRE

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09:47 EDT Cadre falls -8.6% - Cadre is down -8.6%, or -$2.12 to $22.51.
ARIS

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09:47 EDT Aris Water Solutions falls -11.1% - Aris Water Solutions is down -11.1%, or -$2.35 to $18.81.
BEKE

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09:47 EDT KE Holdings rises 6.3% - KE Holdings is up 6.3%, or 96c to $16.29.
EVEX

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09:47 EDT Eve Holding rises 7.4% - Eve Holding is up 7.4%, or 59c to $8.53.
EDU

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09:47 EDT New Oriental Education rises 12.3% - New Oriental Education is up 12.3%, or $1.81 to $16.53.
REDU

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09:46 EDT NYSE cancels Rise Education trades above $1.72 between 6:26 and 8:06 ET - NYSE Arca Equities has ruled to bust all trades in Rise Education executed between 6:26 and 8:06 ET today, at or above $1.72. "This ruling is not eligible for appeal," it added.
AZYO

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09:42 EDT Aziyo Biologics Inc (Class A Stock) trading resumes
FULC

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09:39 EDT Fulcrum Therapeutics trading resumes
FULC

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09:34 EDT Fulcrum Therapeutics trading halted, volatility trading pause
AZYO

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09:32 EDT Aziyo Biologics Inc (Class A Stock) trading halted, volatility trading pause
YNDX

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09:22 EDT Yandex announces terms for purchase of convertible notes - Yandex has announced that the terms of its $1.25 billion 0.75% Convertible Notes due 2025 have been amended and that it has agreed terms with the steering committee of an ad hoc group of noteholders for the purchase by Yandex and its subsidiary of Notes from participating noteholders. The Ad Hoc Group is being advised by Weil, Gotshal & Manges (London) LLP and Houlihan Lokey EMEA LLP. The indicative terms of the Purchase provide for a purchase price of $140,000 in cash and 957 Yandex Class A shares for each $200,000 in principal amount of Notes purchased. Yandex will use its commercially reasonable efforts to deliver the share consideration following the closing of the Purchase when it is permissible for the relevant shares to be delivered and received under applicable laws and regulations.The Yandex group intends to fund the cash component of the Purchase Price primarily by means of a commercial loan in compliance with Russian, United States, United Kingdom, European Union and United Nations laws and regulations. Yandex intends to implement the Purchase by way of one or more agreements with participating noteholders. Yandex expects that each Purchase Agreements will be subject to certain conditions precedent, including the agreement of all definitive documentation required to implement the Purchase, that all necessary authorisations and government approvals will have been obtained for the Purchase and that the consummation of the Purchase will not conflict with any applicable law or regulation. Yandex intends to surrender any Notes purchased by it pursuant to the Purchase to the Principal Paying, Transfer and Conversion Agent for the Notes for cancellation in accordance with the terms and conditions of the Notes. The majority of such cancellations are expected to take place immediately after completion of the Purchase, with the remainder taking place when it is permissible to do so in accordance with applicable laws and regulations.
CDW AN

Hot Stocks

09:21 EDT CDW announces addition of two new strategy, marketing executives - CDW (CDW) announced the addition of two new strategy and marketing leaders. Anand Rao is joining the organization as chief marketing and digital officer while Michael Drory has joined as senior vice president of strategy and corporate development. Both leaders will serve on the company's executive committee and report to Sona Chawla, chief growth and innovation officer. Rao joins CDW from AutoNation (AN) where he served as senior vice president, digital business. Drory comes to CDW from ADT Security Services, where he most recently served as vice president, consumer sales operations and strategy.
WTBA

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09:20 EDT West Bancorp announces pricing of subordinated notes offering - West Bancorporation announced the pricing of its offering of $60 million of 5.25% Fixed-to-Floating Rate Subordinated Notes due 2032. The Notes will initially bear interest at 5.25% per annum, with interest payable semi-annually in arrears, commencing on the issue date, to, but excluding, June 15, 2027. Commencing June 15, 2027, the interest rate on the Notes will reset quarterly to a floating rate per annum equal to a benchmark rate that is expected to be Three-Month Term SOFR plus 241 basis points, with interest payable quarterly in arrears. The Company may redeem the Notes, in whole or in part, on and after June 15, 2027, at a price equal to 100% of the principal amount of the Notes being redeemed plus accrued and unpaid interest. The Notes will mature on June 15, 2032 if they are not earlier redeemed. The Company expects to close the transaction, subject to customary conditions, on or about June 14, 2022. The Company intends to use the net proceeds of the offering for general corporate purposes, including providing capital to support organic growth and for investing in West Bank as regulatory capital. The Notes are intended to qualify as Tier 2 capital for regulatory purposes. Piper Sandler & Co. is acting as the sole underwriter for the offering.
ZYME

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09:16 EDT Zymeworks adopts limited-duration shareholder rights plan - Zymeworks announced that its board of director has adopted a limited-duration shareholder rights plan. The Board adopted the Rights Plan in response to the unsolicited, non-binding proposal by All Blue Falcons FZE to acquire Zymeworks and All Blue's continued share accumulations. The Rights Plan is intended to enable all shareholders to realize the full value of their investment in Zymeworks. The Rights Plan will reduce the likelihood that any entity, person or group gains control of Zymeworks through open market accumulation without paying all shareholders an appropriate control premium. It will also provide the Board with the appropriate time to make informed judgments and take actions that are in the best interests of all shareholders. The Rights Plan does not prevent the Board from engaging with parties or accepting an acquisition proposal if the Board believes that it is in the best interests of Zymeworks and its shareholders. The Rights Plan is similar to shareholder rights plans adopted by other companies in comparable circumstances. The Rights Plan will expire on June 8, 2023.
ENG

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09:09 EDT ENG announces annual meeting results - ENG reported that the company's 2022 annual stockholders' meeting was held yesterday morning in Houston. Approximately 61% of ENG's total common stock outstanding was represented at the meeting, either in person or by proxy. Of those shares, at least 94% were cast in favor of the election of William Coskey, P.E., Mark Hess, Lloyd Kirchner, Christopher Sorrells, and Kevin Palma to a one-year term on the company's Board of Directors. Approximately 98% of the shares were cast in favor of the ratification of the appointment of Moss Adams for the fiscal year 2022 and approximately 99% of the shares were cast in favor of a non-binding "say-on-pay" advisory vote on the compensation of the above named executive officers.
DKNG

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09:08 EDT DraftKings, UFC extend strategic relationship for gamified NFTs - UFC and DraftKings announced plans to launch a new iteration of DraftKings' "Reignmakers" gamified digital collectibles franchise focused on UFC. Reignmakers UFC will allow fans to build collections of their favorite UFC fighters and utilize them in games to compete for prizes. The first season of Reignmakers UFC NFT-based games is expected to go live later this year. Ahead of the launch of the game, fans can soon begin collecting the initial NFTs of fighters via auctions and drops in DraftKings' "Heatwave Series," which will be based around this summer's UFC events schedule, beginning with UFC 276: ADESANYA vs. CANNONIER on July 2. Collectors will receive rewards both leading into and following the game rollout based on the utility of the NFT which could include entries into special daily fantasy contests for cash, custom merchandise and more. Under the new agreement with UFC, DraftKings Marketplace will have access to fighter IP from over 500 different athletes on the active UFC roster from which to choose to create the Reignmakers UFC collection.
ATVI MSFT

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09:08 EDT Activision Blizzard to recognize, begin negotiations with CWA - Activision Blizzard (ATVI) CEO Bobby Kotick today sent the following letter to all US employees: "Team, I wanted to share the news that we will begin negotiations with the Communications Workers of America, CWA, related to the 27 quality assurance employees at Raven Software, the majority of whom have chosen to be represented by this union. With the election having concluded, we will engage in good faith negotiations to enter into a collective bargaining agreement. While first labor contracts can take some time to complete, we will meet CWA leaders at the bargaining table and work toward an agreement that supports the success of all our employees... We begin this process after major investments in our QA team members over the past couple years, including significantly increasing starting pay for QA specialists and converting over 1,100 U.S.-based temporary and contingent QA workers to full-time positions. This conversion is providing access to comprehensive company benefits for QA employees and their eligible dependents." The Fly notes that Microsoft (MSFT) earlier this year agreed to acquire Activision Blizzard.
ONCT

Hot Stocks

09:07 EDT Oncternal Therapeutics presents rationale, plans for Phase 3 ZILO-301 trial - Oncternal Therapeutics announced that the rationale and plans for its upcoming Phase 3 ZILO-301 clinical trial will be highlighted in a poster presentation at the European Hematology Association 2022 Hybrid Congress. ZILO-301 is designed to evaluate the efficacy and safety of zilovertamab, an investigational anti-ROR1 monoclonal antibody, plus ibrutinib compared to ibrutinib monotherapy for the treatment of patients with relapsed or refractory mantle cell lymphoma. Poster Title: Study ZILO-301: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Zilovertamab Plus Ibrutinib vs. Ibrutinib in Patients with Relapsed or Refractory Mantle Cell Lymphoma. Zilovertamab is being evaluated in combination with ibrutinib in patients with R/R MCL and chronic lymphocytic leukemia in the Phase 1/2 study, CIRM-0001. The most recent interim data update showed an Objective Response Rate of 85% and a Complete Response rate of 41% in 27 evaluable patients with mantle cell lymphoma, both of which compare favorably to the historical ORR of 66% and CR rate of 20% for ibrutinib monotherapy. The phase 3 study, ZILO-301, will evaluate the potential benefit for patients who achieve either a partial response or stable disease during a lead-in with ibrutinib monotherapy. Initially, patients enrolled in ZILO-301 will receive single agent ibrutinib for 4 months. Patients with an inadequate response will be randomized to receive zilovertamab or placebo while continuing to receive ibrutinib. The study aims to randomize approximately 250 patients. Key Inclusion criteria: Adults with histologically confirmed MCL; Relapsed or refractory with at least 1 prior therapy; Primary Objective: Progression-free survival among subjects who had a PR or SD after open-label ibrutinib monotherapy phase and were randomized to receive zilovertamab + ibrutinib or ibrutinib + placebo. Secondary Objectives: Objective Response Rate and Duration of Response; Complete Response Rate; Overall Survival; Proportion of subjects experiencing grade 3 or 4 neutrophil count decrease and overall safety profile.
VZ

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09:04 EDT Verizon reports 5G Ultra Wideband at Governors Ball Music Festival - Verizon is bringing concertgoers a new way to experience Governors Ball Music Festival this weekend with Verizon 5G Ultra Wideband. For the more than 150,000 people expected to attend the popular music festival at Citi Field in New York City, Verizon and Snap Inc. will power a transformative 5G AR experience in front of the festival's main stage. Following the first-of-its-kind Connected Lens for Super Bowl LVI, Verizon and Snap have teamed up again for a new Connected Lens experience at The Governors Ball Music Festival, a continuation of how Verizon and Snap are partnering to enhance the fan experience and future of live events. Remote Connected Lenses on Snapchat allow people to create shared AR experiences that friends can utilize together at the same time, and return to over time.
TTOO

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09:04 EDT T2 Biosystems granted extension from Nasdaq to comply with bid price rule - T2 Biosystems announced that the Nasdaq Hearings Panel has granted the Company's request for an extension until November 1, 2022, to regain compliance with Nasdaq's minimum bid price requirement, as set forth in Nasdaq Listing Rule 5550(a)(2). To satisfy the Bid Price Rule in accordance with the terms of the Panel's decision, by November 1, 2022, the Company must evidence a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days. If the Company is able to do so within the prescribed time period and satisfies all other applicable criteria for continued listing, the matter will be closed. During the extension period, the Company will continue to actively monitor the stock price while it considers the options available to it and to take action, if necessary and as deemed appropriate by the Company's board, to remedy the deficiency, including potentially effecting a reverse stock split. There can be no assurance that the Company will be able to timely comply with the terms of the Panel's decision and, if it cannot, the Company's common stock will be delisted from Nasdaq. The Panel also approved the Company's request to transfer its listing of common stock from The Nasdaq Global Market to The Nasdaq Capital Market tier, which transfer will take effect prior to the open of business on June 13, 2022. The transfer is not expected to have any impact on trading in the Company's common stock, which will continue to trade under the symbol "TTOO." The Capital Market tier operates in substantially the same manner as the Global Market tier, with both tiers requiring issuers to satisfy certain minimum financial and corporate governance criteria to qualify for continued listing on Nasdaq.
CVGI

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09:03 EDT CVG appoints Minja Zahirovic as president, warehouse automation - CVG announced that Minja Zahirovic has been appointed to the role of President of Warehouse Automation. This new role was created to advance the company's warehouse automation program as it continues strategic expansion in the market. Most recently, Zahirovic served as the Vice President of System Solutions at Festo North America, and prior to that held leadership and engineering positions at Irco Automation and Liburdi Engineering.
YAMHF

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09:02 EDT Yamaha Motor breaks ground on SMART Warehouse in Georgia - Yamaha Motor Manufacturing broke ground yesterday on a new, advanced, and innovative "SMART" Warehouse, the first-of-its-kind for Yamaha Motor Company worldwide. Using state-of-the-art automated storage and retrieval systems, the new 200,000 square foot facility will be capable of reducing response time for fulfilling dealer orders for Yamaha WaveRunners, Golf Cars, ATVs, and Side-by-Sides by more than 50 percent. "The new Yamaha SMART Warehouse will improve our overall operational efficiency and the velocity of material flow to our factory assembly lines, allowing us to ultimately get product in the hands of our dealers and customers faster," said Mike Chrzanowski, President and CEO of Yamaha Motor Corporation. "The demand for all our outdoor recreational products produced at this factory continues to exceed supply and we are pleased to bring this new warehouse facility online as soon as possible." SMART is an acronym for Sequenced Material and Reduced Transportation. Yamaha expects to complete the SMART Warehouse in 2024.
BCC

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08:47 EDT Boise Cascade reaches agreement to acquire Coastal Plywood for $512M - Boise Cascade Company announced that it has reached an agreement to acquire Coastal Plywood Company, including its two manufacturing locations, from Coastal Forest Resources Company for $512M, subject to certain closing adjustments. The Company currently plans to fund the transaction and closing-related expenses from its existing cash balances. "This acquisition incrementally expands our veneer capacity in support of our customers," said Nate Jorgensen, CEO, Boise Cascade. "Near term, it provides us the ability to optimize our existing engineered wood products asset base. Longer term, we are excited to fully integrate this strategic venture and we intend to invest $50 million into our Southeast operations over a three-year period to further our EWP production capacity." The scope of this transaction does not include Coastal's parent company or timberlands assets. Closing of the acquisition is expected in the third quarter of 2022, subject to customary closing conditions, including receipt of antitrust approval under the Hart-Scott-Rodino Act of 1976, as amended.
IFMK

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08:36 EDT iFresh CEO Long Deng responds to SEC allegations - On May 31, 2022, the Securities and Exchange Commission filed a civil lawsuit alleging civil violations of the federal securities laws against iFresh and Long Deng, the company's CEO throughout the period at issue in the Complaint, for not fully disclosing related party transactions, which, the Commission alleged made certain of the company's financial statements materially inaccurate. Mr. Deng, through one of his attorneys, Jacob Frenkel, Chair of the Securities Enforcement and Government Investigations Practice at national law firm, Dickinson Wright, PLLC, responds to the allegations. "Mr. Deng looks forward to his day in court to fight vigorously the SEC's allegations. The defense that Mr. Deng will present already is well-known to the SEC from his cooperation in and multi-day sworn testimony in the SEC's inquiry that gave rise to the civil lawsuit. Mr. Deng, who had no prior experience with US public companies, hired professionals internally to iFresh in financial reporting leadership roles and externally as independent auditors and lawyers to make certain that the Company's financial statements and disclosures complied fully with US federal securities laws. We are confident that the evidence will be that Mr. Deng relied on the advice and counsel of these professionals, and that a jury in this civil case will find that Mr. Deng is not responsible for the violations that the Commission alleges were committed in connection with the Company's financial reporting. The evidence also will be that Mr. Deng did not profit personally as a result of the allegations. I look forward to working closely with Angus Ni of AFN Law PLLC, to defend Mr. Deng in this civil lawsuit. This case is just beginning, and we are a long way from any evidence being presented to a jury."
JNJ

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08:35 EDT Janssen presents updated data at EHA for teclistamab - The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated efficacy and safety results from the teclistamab cohort of the Phase 1b TriMM-2 study. Patients in the study, including a high proportion with prior anti-CD38 monoclonal antibody exposure, achieved encouraging overall response rates, ORR, with this combination treatment. These data will be presented at the 2022 European Hematology Association, EHA, Annual Congress as an oral presentation on Sunday, 12 June. At a median follow-up of 8.6 months, 76.5 percent of response-evaluable patients enrolled in the study achieved a response, including 36 patients who achieved a very good partial response or better. In patients with prior anti-CD38 exposure, an ORR of 73.7 percent was achieved.1 The median time to first confirmed response was one month, and responses remained durable and deepened over time.1 At the analysis cut-off, 66.7 percent of patients who achieved a response were alive and continuing on therapy. The open-label, multicentre, multicohort Phase 1b TriMM-2 study is investigating the safety and efficacy of teclistamab in combination with daratumumab SC for patients with RRMM. As of April 6, 2022, 65 patients received daratumumab SC 1,800mg at the approved schedule plus teclistamab 1.5mg/kg weekly or 3mg/kg every other week subcutaneously. Pre-medications, including steroids, were limited to the two step-up doses and the first full dose of teclistamab. Treatment with the combination regimen were tolerable and no unexpected or overlapping toxicities were observed. The most common adverse events were cytokine release syndrome; neutropenia; and anaemia. One patient had Grade 1 immune effector cell-associated neurotoxicity syndrome which fully resolved. Infections were experienced by 67.7 percent of patients. Four patients died from AEs, all unrelated to teclistamab or daratumumab SC treatment. The efficacy and pharmacodynamic profile of teclistamab in combination with daratumumab SC in patients refractory to anti-CD38 therapy suggest that higher response rates may be observed in patients with anti-CD38 naive or sensitive disease who are enrolling in the MajesTEC-3 study.
BIMI

Hot Stocks

08:33 EDT BIMI International Medical enters $5M stock purchase agreement - BIMI International Medical announced that on June 9, 2022, the Company entered into a Stock Purchase Agreement with Mr. Fnu Oudom, the Chairman of the Board of the Company, for the sale of 12,500,000 shares of common stock of the Company for $5 million, subject to stockholder approval. On June 9, 2022, the Company entered into a Stock Purchase Agreement with the Chairman of the Board of the Company, Mr. Fnu Oudom, whereby Mr. Oudom agreed to purchase 12,500,000 shares of common stock of the Company for $5 million, or $0.40 per share, subject to stockholder approval. The purchase price per share reflects a 9% discount on the five-day average closing price of the Common Stock on NASDAQ before signing the SPA. On June 9, 2022, Mr. Oudom provided the Company with $5 million as interim financing in consideration for the issuance of a $5 million subordinated promissory note, bearing no interest, which will become due and payable immediately if the sale of the Chairman's Shares is not approved by the Company's stockholders. The Company expects to seek stockholder approval of the sale at the upcoming annual meeting of stockholders. If approved and the Chairman's Shares are issued, all obligations under the Chairman's Note will have been performed and discharged in full without any payment of interest. The Company has no obligation to file a registration statement with the SEC for the resale of the Chairman's Shares. On June 9, 2022, the Company entered into a waiver and consent agreement with two institutional investors with respect to the Company's obligations under the Securities Purchase Agreement dated November 18, 2021 by and among the Company and the Holders. Pursuant to the Waiver Agreement, the Holders waived certain the Company's obligations under the 2021 SPA with respect to additional issuances of securities and the issuance of additional debt and the Holders' right with respect to participation rights. In consideration for the Holders providing the waivers, the Company agreed that it will use $500,000 of the proceeds to pay down portions of each Holder's promissory note, half of which amount will be paid upon the issuance of the Chairman's Note and the remainder will be paid if stockholder approval is obtained.
ABVC

Hot Stocks

08:32 EDT ABVC BioPharma announces termination of two contracts - ABVC Biopharma announced that two contracts entered into in the last 45 days have been terminated. The first of the two contracts, announced on May 3, 2022, was a $3.0 million clinical services agreement between BioKey, a wholly-owned subsidiary of the company based in Fremont, California, and NeuCen BioMed, based in Taipei, Taiwan. Under the terms of the now terminated agreement, BioKey was to be paid $3.0 million over a 3-year period to guide two NeuCen drug products, CEN501 and NEU001, through completion of Phase II clinical studies under U.S. FDA IND regulatory requirements. ABVC and NeuCen had also agreed, subject to further negotiation, that ABVC would loan NeuCen $1.0 million through a series of convertible debentures. The second terminated contract was between ABVC BioPharma and Orion Biotech, a Taipei-based affiliate of NeuCen. The second contract, announced on May 25, 2022, called for ABVC BioPharma to identify candidates interested in out-licensing Orion developmental products. Under the terms of this engagement, ABVC was to use its business relationships around the world to identify licensing partners for Orion products and, in return, would receive a monthly retainer fee and 15% of the licensing income and royalties received by Orion for each licensed product. The party's inability to agree to the final terms of the loan between BioKey and NeuCen led to termination of both contracts on June 6, 2022, effective immediately.
TROW

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08:31 EDT T. Rowe Price reports preliminary AUM $1.40T at May 31 - Client transfers from mutual funds to other portfolios, including trusts and separate accounts, were negligible for the month of May. Client transfers for the quarter-to-date and year-to-date periods ended May 31 were $1.7B and $5.8B, respectively. These client transfers include $0.6B and $3.9B, respectively, transferred to the target date retirement trusts during the quarter-to-date and the year-to-date periods.
GDBYF

Hot Stocks

08:28 EDT Goodbody Health announces intention to delist from CSE - Goodbody Health announced its intention to de-list from the Canadian Securities Exchange and to re-domicile the Company from the Province of British Columbia to Guernsey, subject to shareholder approval. This re-domiciliation is intended to better align Goodbody's corporate structure with its current and future business activities. Goodbody has a substantial business presence in the United Kingdom and the European Union, including all of its operations, management and workforce. In addition, the fastest-growing segments of Goodbody, are currently in the United Kingdom. Goodbody does not anticipate any impact for employees, day-to-day operations, or products and services as a result of the re-domiciliation, and Goodbody intends to retain its listing on the AQSE Growth Market in London and the OTCQB in North America, which will ensure that trading in the Company's shares remains possible for both UK and North American investors. Goodbody's Board of Directors believes that the proposed plan to change its location of incorporation from the Province of British Columbia to Guernsey will provide the Company with many benefits, including: Positions the Company in proximity to a leading global financial centre and Europe's transaction hub, a location where it has substantial existing business activities and significant opportunities for continued growth; Elevates the Company's visibility among potential U.K. and other European institutional investors; Positions the Company to allow future earnings and cash flows to more efficiently fund its ongoing U.K. and European expansion; Reduces the costs and time spent procuring that the Company complies with the requirements associated with two material listings that have entirely different regulatory regimes which will allow management to focus on commercial activities; and Reduces currency risk. Shareholders will have the opportunity to vote on the proposed plan at the annual general and special meeting expected to be held in August 2022. Subject to shareholder approval, the Company anticipates that the change of the place of incorporation will become effective later in the third quarter of 2022. Shareholders' will continue to hold the exact number of shares, as they currently hold in Goodbody common shares and their shareholdings will be unchanged following the re-domiciliation. As the Company will be subject to the laws of Guernsey following the re-domiciliation, new articles of association of the Company will be adopted detailing the rights attaching to the Company's shares. With effect from the re-domiciliation, the Company's common shares will be renamed as "ordinary shares". The Company also intends to have its common shares voluntarily de-listed from trading on the CSE prior to or concurrently with the effective time of the re-domiciliation and the Company also intends that its ordinary shares will continue to be admitted to trading on the AQSE Growth Market in London. The Company expects to publish a circular to propose the CSE de-listing of the Company and re-domiciliation to Guernsey by no later than 19th July 2022, being at least 21 days prior to the expected date of the Annual General Meeting. The circular will include, amongst other things, particulars of the main differences between the Company's current constitution and the new articles to be adopted pursuant to the re-domiciliation. Goodbody is pleased to announce that it has appointed Peterhouse Capital Limited as the Company's Corporate Adviser with immediate effect.
GLAQ AFRI

Hot Stocks

08:26 EDT Globis Acquisitionc closes business combination with Forafric - Globis Acquisition announced that it has closed a business combination with Forafric Agro Holdings Limited, a global agribusiness company serving Africa. The transaction was approved at a special meeting of Globis' stockholders on June 9, 2022. The combined company, which will do business as Forafric Global, expects that its ordinary shares and public warrants will commence trading on the Nasdaq Capital Market under the new trading symbols 'AFRI' and 'AFRIW,' respectively, starting on Friday, June 10, 2022. In conjunction with the business combination, Forafric raised $44.8 million in new capital, which includes $19.4 million in a SPAC trust account. The company plans to use the proceeds to support its strategic and operational plans for expansion.
STLA

Hot Stocks

08:25 EDT Stellantis demonstrates DWPT technology at 'Arena del Futuro' - After months of testing at the "Arena del Futuro" circuit, Stellantis, together with its project partners, demonstrated in Chiari, Italy, the capability of Dynamic Wireless Power transfer technology to wirelessly recharge electric vehicles as they travel over specially equipped, dedicated road lanes. DWPT is a system of coils positioned under the asphalt that transfers energy directly to cars, trucks and buses without the need to stop at charging stations to refill the battery. The technology can be adapted for all vehicles equipped with a special "receiver" that transfers the energy incoming from the road infrastructure directly to the electric motor, extending the range, while conserving the vehicle battery charge. The pilot project of Stellantis and all partners involved is coordinated by A35 Brebemi, a company owned by the global transportation infrastructure operator Aleatica that focuses on sustainable and innovative mobility solutions.
DUOL

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08:24 EDT Duolingo set to join Russell 3000, Russell 2000 Indexes - Duolingo announced it is set to join the broad-market Russell 3000 and the small-cap Russell 2000 Indexes at the conclusion of the 2022 Russell indexes annual reconstitution, effective after the U.S. market opens on June 27, 2022 according to a preliminary list of additions posted June 3, 2022.
AGEN GSK

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08:23 EDT Agenus says GSK announces interim analysis of AReSVi 006 Phase III trial - Agenus shared that partner GSK announced headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial evaluating their investigational RSV vaccine in adults aged 60 years and above. The primary endpoint was exceeded with no unexpected safety concerns observed. Engagement with regulators is planned to start immediately with anticipated regulatory submissions in H2 2022. GSK's RSV vaccine candidate contains Agenus' proprietary QS-21 STIMULON within its AS01 adjuvant, which - in the context of other antigens - has already demonstrated positive immune responses as well as a favorable safety profile. QS-21 STIMULON is a critical component of the AS01 adjuvant used in multiple GSK vaccines, including GSK's FDA approved Shingrix shingles vaccine, and the world's first malaria vaccine Mosquirix, endorsed by the WHO. Agenus' subsidiary, SaponiQx, has developed a plant cell culture method of manufacturing QS-21 STIMULON, which is designed to support its broader use based on sustainable, scalable, and cost-effective supply. SaponiQx expects to generate GMP material using this process before the end of the year to enable partner clinical trials. Once SaponiQx's plant cell culture process is fully scaled, Agenus' wholly-owned manufacturing campus is designed to support the capacity for broad use across disease settings, as well as scalability to address future pandemic threats.
GTBP

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08:22 EDT GT Biopharma presents preclinical data on GTB-7550 in CLL - GT Biopharma announced preclinical data in chronic lymphocytic leukemia to be presented at the European Hematology Association 2022 Congress. The poster presentation titled, "Second-Generation CD19 Targeting Tri-Specific Killer Engager Drives Robust NK Cell Function Against B Cell Malignancies," presented by Dr. Jeff Miller's laboratory, University of Minnesota. GTB-7550 is the Company's CD19-targeted tri-specific killer engager targeted against B-cell lymphomas and is part of GT Biopharma's portfolio of TriKE product candidates being investigated in several preclinical models against a broad class of solid tumors and hematological cancers. Poster Title - "Second-Generation CD19 Targeting Tri-Specific Killer Engager Drives Robust NK Cell Function Against B Cell Malignancies": Background - According to the American Cancer Society, CLL accounts for about one-quarter of the new cases of leukemia. In 2022, an estimated 20,160 people will develop CLL, and about 4,410 will die from CLL. Existing targeted therapies for B cell malignancies work well in a subsegment of the patient population, but face limitations such as development of drug resistance and lower treatment efficacy ratio in high-risk patients. Other therapeutic options such as CAR-T cell immunotherapy have failed to produce effective treatment outcomes against CLL, mostly due to the defects in the effector T cells leading to product failures, as well as being associated with high levels of off-target cytotoxicity. Therefore, there is a critical need for novel and targeted therapeutic interventions for the treatment of CLL patients. Study Design and Analysis - CLL involves uncontrollable clonal expression of CD5+/CD19+ B lymphocytes. While patients can sometimes coexist with CLL for years, eventually there is progression to bulky adenopathy and pancytopenia from bone marrow suppression requiring therapy. We developed and tested the ability of GTB-7550, a second-generation tri-specific killer engager to enhance NK killing specific to CD19+ cancer targets. This TriKE molecule includes a humanized camelid anti-CD16 VHH single domain antibody CAM16, a wild-type IL-15 component, and anti-CD19 tumor antigen scFv all linked via short peptide linkers. We assessed GTB-7550 killing of Raji tumor targets by C9-dervied expanded NKs in IncuCyte real time imaging assay. Results - GTB-7750 TriKE enhances NK cell proliferation as compared to IL-15 moiety and no treatment at the end of a seven-day long assay. GTB-7550 TriKE enhanced CLL patient NK activation and Raji target killing, and it amplified feeder-expanded NK cell function against B-ALL targets. Conclusions - There is a critical need for a novel approach to CLL treatment that can effectively address the limitations in existing approaches that induce development of drug resistance and have lower treatment efficacy in high-risk patients. Other novel approaches such as CAR-T cell immunotherapy have failed to produce effective treatment outcomes against CLL, mostly due to defects in the effector T cells leading to product failures, as well as high levels of off-target cytotoxicity. Treatment with GTB-7750 TriKE enhances proliferation of NK cells and improves normal NK cell function against multiple B cell malignancies. Ongoing experiments will evaluate the functionality and efficacy of GTB-7750 in vivo. Future studies will involve assessments of the GTB-7750 TriKE in other hematological malignancies.
EGO

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08:20 EDT Eldorado announces election of directors, voting results from annual meeting - Eldorado Gold Corporation announced that all director nominees, as listed in the Management Proxy Circular dated April 25, 2022, were elected as directors of Eldorado at the Company's Annual Meeting of Shareholders held on June 9, 2022. "On behalf of the Board, we would like to thank our shareholders for their ongoing feedback and support for the governance efforts and the strategic direction we have undertaken," said Steven Reid, Chair of Eldorado Gold's Board of Directors. Further, we would like to thank George Albino, who did not stand for re-election this year, for his sound counsel and guidance during his tenure. During his five-and-a-half-years of service, George served on numerous key Board committees and was Chair during three transformative years at Eldorado, from 2018 to 2021. His guidance during this time was invaluable to the Board and Eldorado's leadership team, and he will be greatly missed. In addition, we are pleased to welcome Stephen Walker. Mr. Walker has over 35 years of experience in capital markets, focused on the mineral resource industry. Prior to his retirement from his 20-year tenure at the Royal Bank, he held varying roles, including Managing Director and Head of Global Mining Research from 2007 to 2020. Please join me in welcoming Stephen to the Board." At the Meeting, shareholders of the Company also approved: The appointment of auditors; Setting the auditor's pay; and The advisory resolution on executive compensation.
BNGO

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08:18 EDT Bionano Genomics announces participation at ESHG 2022 featuring OGM - Bionano Genomics announced its participation at the European Society of Human Genetics 2022 Conference, with 13 scientific and poster presentations highlighting the application of OGM across rare undiagnosed genetic disease and genetic disorders. Additionally, Bionano and Hamilton will present the Long String VANTAGE, the world's first automation solution for UHMW extraction used in OGM. ESHG is an annual conference that brings together industry and academic professionals to discuss new technologies and advances in the field of human genetics. ESHG sessions will take place June 11-14, 2022 virtually and in Vienna, Austria. Bionano and Hamilton jointly announced the Long String VANTAGE, which is the first Assay Ready Workstation solution in Hamilton's Long String Genomics product program which supports extraction of UHMW DNA at increased scale. Attendees at ESHG will be able to learn more about the Long String VANTAGE at both companies' booths and can experience a demonstration of the workflow at Hamilton's booth throughout the conference. As part of a corporate satellite presentation, Dr. Detlef Trost from Laboratoire CERBA, and Dr. Alexander Hoischen from Radboud UMC, will share their latest research on OGM for RUGD. Three genomics researchers will participate in separate featured scientific presentations, highlighting use of OGM in genetic disorder testing. Dr. Claudia Carvalho of the Pacific Northwest Research Institute will present on complex genomic rearrangement structures in neurodevelopmental disorders. Dr. Laila El Khattabi will present on a recent study highlighting the OGM in the characterization of complex SVs. Dr. Kornelia Neveling from Radboud UMC will present on repeat expansion disorder testing using OGM.
VTSI

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08:17 EDT VirTra granted listing extension by Nasdaq - VirTra announced today that the Company received notice from the Listing Qualifications Department of the Nasdaq Stock Market that its request for an extension to regain compliance with the Nasdaq Listing Rules has been granted. VirTra has until August 12, 2022 to file both its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and its Form 10-Q for the quarter ended March 31, 2022 with the U.S. Securities and Exchange Commission. VirTra expects to file the 2021 Annual Report and Form 10-Q by August 12, 2022 and regain compliance with the Nasdaq Listing Rules. As previously disclosed on April 7, 2022 and May 19, 2022 VirTra received notices from the Listing Qualifications Department of Nasdaq on April 5, 2022 and May 17, 2022, respectively, stating that the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1) because it had not timely filed its 2021 Annual Report and Form 10-Q with the U.S. Securities and Exchange Commission. Nasdaq Listing Rule 5250(c)(1) requires listed companies to timely file all required public financial reports with the SEC.
IVCGF

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08:16 EDT IVECO, IVECO BUS partner with 'Arena del Futuro' - Italy's pilot project on inductive recharging technology for electric vehicles was presented today at the "Arena del Futuro" test circuit in Chiari. IVECO and IVECO BUS are involved in the project alongside other industrial partners, universities and international institutions. Coordinated by A35 Brebemi and Aleatica, the project was launched in May 2021. Its aim is to demonstrate the effectiveness and efficiency of charging electric vehicles using contactless dynamic inductive currents. The technology makes it possible for electric vehicles to recharge their batteries while travelling in dedicated lanes, thanks to an innovative system of coils positioned under the asphalt that transfer energy directly to on-board batteries. IVECO BUS contributed to the project with a 12-metre electric E-WAY, retrofitted with the necessary connectivity and recharging technology. Tests were carried out on a 1 km asphalt circuit powered by inductive currents, with the bus reaching speeds of over 70 km/h and receiving 75kW of electrical power. These test conditions are very close to real conditions, which is one of the reasons why "Arena del Futuro" is a unique project.
MSSTF

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08:15 EDT Mindset receives notice of allowance for patent covering Psilocin derivates - Mindset Pharma announced that the United States Patent and Trademark Office has issued a Notice of Allowance for Mindset's patent application number 17/387,845, titled, "Psilocin Derivatives as Serotonergic Psychedelic Agents for the Treatment of CNS Disorders." The patent carries a priority date of February 4, 2020. Included within this application are several drug candidates that the Company classifies as belonging to its "Family 1" which are second-generation compounds with potential improvements compared to psilocybin in pharmacokinetics, effect size, safety, and manufacturing.
ORYZF

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08:14 EDT Oryzon Genomics presents efficacy data from Phase IIa ALICE trial - Oryzon Genomics presents new efficacy data from its ongoing Phase IIa ALICE trial, investigating iadademstat in combination with azacitidine in elderly or unfit patients with acute myeloid leukemia , in a poster at the European Hematology Association annual congress, being held in Vienna on June 9-12. The evidence of clinical efficacy continues to be robust and consistent with previously reported data, with an objective response rate of 81%; of these, 64% were complete remissions and 36% partial remissions. The historical ORR in elderly or unfit AML population treated with azacitidine alone is 28%. Eighty-six percent of the CR/CRi patients became transfusion-independent, and 75% of CR tested samples were MDR negative by flow cytometry. Of note, among AML subgroups all evaluable patients with FLT3-ITD and 6 of 8 evaluable patients with p53 mutations responded. Responses are rapid, with 91% of patients responding by end of cycle 2, and durable, with 64% of CR/CRi responses lasting more than 6 months. Three patients remained on study for more than 1 year, 2 patients for more than 2 years and 1 patient for more than 3 years. Six patients are still ongoing in the trial. The combination of iadademstat with azacitidine continues to show a good safety profile, with only two serious adverse events reported as probably related to treatment. The most frequent adverse reaction was platelet reduction, observed in about half of patients, although thrombocytopenia was already present at baseline in a high proportion of patients. Besides the expected hematological impact, in line with the pharmacologic mode of action and previously presented at several ASH and EHA meetings, the combination continues to appear safe and well tolerated by elderly AML patients, with no other significant non-hematological toxicities or other organ-related toxicities observed. Thirty-six patients have been enrolled in the trial and are reported in the poster, with 27 evaluable for efficacy.
GRTS

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08:12 EDT Gritstone announces results from preclinical study of samRNA vaccine - Gritstone bio announced results from a preclinical study evaluating a self-amplifying mRNA vaccine candidate against SARS-CoV-2 were published in Nature Communications, in an article titled "Low-dose self-amplifying mRNA COVID-19 vaccine drives strong protective immunity in non-human primates against SARS-CoV-2 infection". The results of the study, which were previously pre-printed in bioRxiv, show that the samRNA vaccine candidate induced broad and potent neutralizing antibodies and T cell immune responses following administration to non-human primates at low doses, and that these immune responses were protective against SARS-CoV-2 challenge. Since the pre-publication of these data in November 2021, Gritstone disclosed initial results from a Phase 1 study of a samRNA vaccine candidate demonstrating similar outcomes against SARS-CoV-2. The company is currently evaluating samRNA vaccines for coronaviruses and other infectious diseases. Gritstone is currently evaluating four distinct SARS-CoV-2 product candidates across three different Phase 1 clinical trials containing various Spike variants plus additional highly conserved non-Spike T cell epitope sequences within its CORAL program. These studies include homologous and heterologous prime-boost regimens. All three of these studies are ongoing, and data from all are expected during the second half of 2022.
AMTX PCG

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08:11 EDT Aemetis, PG&E hold ribbon cutting for RNG project - Aemetis and Pacific Gas and Electric Company will recognize and celebrate a significant Aemetis Biogas LLC renewable natural gas project milestone today at a ribbon cutting ceremony to be held at the Aemetis Advanced Fuels facility in Keyes, California. The event will feature the commissioning of the company's dairy RNG cleanup and compression unit and interconnection with PG&E's gas pipeline for the Aemetis Biogas Central Dairy Digester Project. The Aemetis RNG system testing has been completed, including testing of the PG&E interconnection unit, which will enable the production and delivery of utility-grade RNG for sale as transportation fuel to California customers via pipeline delivery. When fully built out, the planned 60+ dairies in the Aemetis biogas project are expected to capture more than 1.6 million MMBtu of dairy methane annually, and reduce millions of tons of CO2 equivalent greenhouse gas emissions over the next decade. The Aemetis biogas cleanup unit is co-located at the Aemetis Advanced Fuels ethanol plant and is directly connected to the PG&E natural gas pipeline.
TLSA

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08:09 EDT Tiziana Life Sciences announces purchase of common shares by chairman - Tiziana Life Sciences announces that it has been notified that Panetta Partners Limited, an entity in which Gabriele Cerrone, the Executive Chairman has a beneficial interest, purchased 50,000 common shares at $0.88 per share. The acquisition takes Mr Cerrone's interests from 37.60% to 37.64%.
ODV

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08:09 EDT Osisko Development files technical report for Tintic project - Osisko Development is pleased to announce the filing of a technical report, prepared in accordance with National Instrument 43-101 - Standards of Disclosure for Mineral Projects, on its recently acquired Tintic Project, including the producing underground Trixie Mine located in the state of Utah, USA, pursuant to its 100% acquisition of Tintic Consolidated Metals Company on May 27, 2022. The Tintic Project consists of various past producing precious and base metal mines located in the East Tintic Mining District, Utah, 95 km southwest of Salt Lake City. The Tintic Project is comprised of approximately 17,000 acres, including 14,200 acres of patented mining claims, and was acquired by Osisko Development on May 27, 2022. Trixie, located within the Tintic Project, is an operating gold mine and produces approximately 45 tons per day.The technical report on the Tintic Project, entitled "Technical Report on the Tintic Project, East Tintic Mining District, Utah County, Utah, USA", dated June 10, 2022, prepared by Tom Henricksen provides a summary of the geology and mineralization, description of land and ownership, property history, current development and production at Trixie and recommendations on future work programs. There is currently no mineral resource estimate on the Tintic Project that complies with NI 43-101 and, as such, any decisions in respect of the Tintic Project have been informed by data collected and current best practices adopted by management. The current production at Trixie is directed by underground exploration, face sampling, and drilling. Based on 1,996 underground samples taken in the T2 and T4 mineralized zones along a strike length of 630 ft, the uncapped and unweighted grade is 5.49 oz/t Au and 6.64 oz/t Ag. Mineralization is open in all directions. The discovery of the T2 and T4 structures in late 2020 by TCM showed Au grades associated with high sulphidation alteration hosted within quartzites that are capped by impermeable shales and volcanics. Trixie production is approximately 45 tpd. A total of 27,400 tons of mineralized material was mined at Trixie from September 2020 through to the end of December 2021 generating 15,752 oz of Au and 17,605 oz of silver from the 625 level predominantly from the T2. Total revenue for TCM from January to end of December 2021 was approximately $26.1 million USD. Access to the underground workings is available via an existing operating shaft. Underground exploration is being conducted on the upper level at the same time as extraction of mineralized material for processing. The Company intends to invest at Trixie over the following months to advance exploration initiatives, including the construction of an underground exploration ramp and continuing with diamond drilling and sampling, to inform the preparation of a technical report for an initial mineral resource estimate in accordance with NI 43-101, which is anticipated for release by the end of Q4, 2022. Sean Roosen, CEO of Osisko Development, commented, "The Tintic acquisition is an exciting acquisition for our shareholders as it provides the Company with immediate production and a clear opportunity for exploration. We believe that we have the potential to define the resource estimate and provide a basis for future production at a low capital cost. We are excited about the quality of exploration targets at Trixie, and the areas beyond Trixie within the large wholly owned district."
VINC

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08:07 EDT Vincerx Pharma presents preclinical, clinical data on VIP152 in Lymphoma - Vincerx Pharma announced a poster presentation of preclinical and clinical data on VIP152, the Company's PTEFb/CDK9 inhibitor, at the European Hematology Association 2022 Congress, being held virtually and in Vienna, Austria from June 9-12, 2022. The EHA poster presents data from a high-grade B-cell lymphoma patient with a treatment-related decrease in circulating tumor TP53 mutation and preclinically demonstrates sensitivity of cells derived from chronic lymphocytic leukemia patients relapsed after ibrutinib and venetoclax to VIP152 regardless of their TP53 mutation status. The EHA poster also shares new data for 5 lymphoma patients: 3 with HGBL, 1 double expressor diffuse large B-cell lymphoma and 1 CLL patient from 2 ongoing phase 1 trials. The safety, treatment duration, pharmacokinetics, and progressive disease were pooled with 7 previously reported HGBL patients for a total of 12 lymphoma patients shown in the presentation. Key Presentation Highlights: Poster presentation, titled, "VIP152 is a novel CDK9 inhibitor with improved selectivity, target modulation, and cardiac safety in patients with lymphoma," presented by Melanie Frigault, Ph.D., Vice President of Translational Medicine, Vincerx, include: A KINOMEscan assay revealed a range of 'hits' with VIP152 compared with other CDK9 inhibitors. In depth evaluation of all potential hits was performed by Kd determination. Kd values showed VIP152 as the most selective CDK9 inhibitor in the clinic today. In the presence of low ATP, VIP152 has an IC50 value of 4.5 nM, and low nanomolar potency was also maintained in the presence of high ATP. The VIP152 IC50 of 4.5 nM was maintained for 15 to 20 hours in the plasma of patients treated at the current clinical dose of 30 mg. Therefore, VIP152 is a highly potent inhibitor of CDK9 kinase activity even in the presence of high ATP concentrations. These data show that physiologically relevant levels of VIP152 are achieved in patients with the 30-mg dose. In vitro VIP152 treatment led to the most robust downregulation of MYC mRNA expression, observed by a downregulation of 85% genes in two DLBCL cell lines, SU-DHL-4 and SU-DHL-10, compared with atuveciclib and KB-0742. Pooled cardiac safety data from 57 patients demonstrated that VIP152 does not prolong QTc interval after single or multiple doses. VIP152 cytotoxicity was evaluated in CRISPR/Cas9 edited CLL cells with homozygous TP53 mutations and showed that wild type and TP53 mutant cell lines were sensitive to VIP152 treatment at 0.5 and 1.0 microM. In vitro treatment of CLL patient-derived cells showed a concentration-dependent reduction in cell viability regardless of number of lines of prior therapy including cells from patients who had relapsed or were refractory to ibrutinib or venetoclax therapy. This presentation includes new data from five patients. The safety, treatment duration, pharmacokinetics, and progressive disease were pooled with 7 previously reported HGBL patients for a total of 12 lymphoma patients shown in the presentation. Duration of treatment for this cohort ranges from 2 weeks to over 3 years. Of the 12 total treated patients, five were evaluable for best overall response. Of these, two patients with double-hit DLBCL achieved complete remission and remain in remission nearly two years after stopping therapy, while others stopped treatment due to clinical or radiographic progression; and, in one case due to investigator decision. The absolute neutrophil count was measured at each treatment visit. Our data show that once weekly dosing of VIP152 allows for the recovery of neutrophils before the next dose. Neutropenia was considered monitorable and manageable with supportive care. Blood-based PD effect showed a robust down-modulation of MYC, MCL1 and PCNA mRNA in all 11 patients analyzed. Circulating tumor DNA changes were monitored in three newly reported patients. In one patient, ctDNA reduction in TP53 mutation, and in CDK6 and MYC copy number was observed after three weeks of VIP152 treatment. ctDNA is currently being investigated as a non-invasive tool to aid with predicting outcomes to treatment in patients with high-risk B-cell lymphoma. Clinical evaluation of VIP152 is currently ongoing in two phase 1 trials in patients with solid tumors or aggressive NHL, and with CLL and Richter Syndrome.
REDU

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08:05 EDT RISE Education Cayman trading halted, news pending
ERFSF

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08:05 EDT Eurofins J3 Resources expands AIHA LAP certification for industrial hygiene - Eurofins J3 Resources, part of Eurofins Built Environment Testing US, announces it has been granted AIHA LAP accreditation as part of a National expansion program of Industrial Hygiene credentials. Eurofins J3 Resources' industrial hygiene service offering to Texas, Louisiana and Gulf Coast based refineries and chemical plants has been extended to now include rapid turnaround time, media/pump supplies and on-staff Certified Industrial Hygienists. The extension to the Eurofins J3 Resources service offering means it now comprises of BTEX and other organics, hexavalent chromium as well as detection of welding fumes and other metals. The expanded accreditation includes NIOSH 1003 Modified, NIOSH 1501 Modified, AT Organic Vapor Analytical Method Modified, SKC 575 Series Passive Sampler Method Modified for Volatile Organic Compounds in air; NIOSH 7303 Modified for metals in air; and OSHA ID-215 Modified for hexavalent chromium.
VCTR

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08:04 EDT Victory Capital reports AUM of $166.9B as of May 31, 2022 - The company reported assets under management, AUM, of $166.9B as of May 31, 2022. Previously, the company reported assets under management of $165.99B on April 30, 2022.
VOR

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08:04 EDT Vor Bio demonstrates multiplex editing of hematopoietic stem cells - Vor Bio announced dual editing of CD33 and CLL-1 in human hematopoietic stem cells demonstrating continued progress on its novel approach for the treatment of acute myeloid leukemia. The data is being presented at the European Hematology Association Congress in Vienna, Austria. The pre-clinical data demonstrates that multiplex deletion by CRISPR/Cas9 of CD33 and CLL-1 from human CD34+ hematopoietic stem and progenitor cells maintained cell function and persisted long-term post engraftment in vivo, with a high-level of editing, no counterselection, and minimum translocation risk when compared to unedited control cells. In addition, genetically modifying HSPCs to remove select cell surface targets does not impair their function and these dual engineered cells showed significant protection from targeted immunotherapy in vitro. AML is the most common type of acute leukemia in adults and is characterized by excessive proliferation of immature myeloid progenitor cells and their failure to properly differentiate into mature blood cells. Healthy donor HSC transplantation is the standard of care and currently around 40% of patients with AML who receive HSC transplantation suffer a relapse of their cancer, with two-year survival rates of less than 20%, highlighting the need for new therapeutic approaches for these patients. Vor Bio is developing a first-in-class treatment approach consisting of gene-edited HSC transplants that are designed to be resistant to targeted therapies, enabling post-transplant use of powerful therapies such as CAR-Ts or other targeted immuno-therapies. This new approach has the potential to protect healthy cells from the damaging effects of cancer-targeted therapies, leaving the cancerous cells exposed and, for the first time, allowing these targeted therapies to be truly cancer-specific sparing the healthy cells.
MSBI MTZ

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08:03 EDT Midland States appoints Sherina Maye Edwards to board of directors - Midland States Bancorp, Inc. (MSBI) announced that Sherina Maye Edwards has been appointed to the Board of Directors of the Company and Midland States Bank. Ms. Edwards is the Chief Strategy Officer of MasTec, Inc. (MTZ).
MN

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08:03 EDT Manning & Napier reports preliminary AUM $19.4B as of May 31 - Compared with $19.6 B at April 30 and $20.6B at March 31.
NISN

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08:02 EDT Nisun International announces $8M share repurchase program - Nisun International announced that its Board of Directors has approved a share repurchase program under which the company may purchase up to $8M of its Class A common shares. The Share Repurchase Program will go into effect in June and is expected to last through the next six months.
TTNP

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08:01 EDT Activist Investing discloses 9.9% ownership interest in Titan Pharmaceuticals - David Lazar, CEO of Activist Investing, one of the largest stockholders of Titan Pharmaceuticals, with 9.9% of the Company's outstanding shares, issued the following statement: "As disclosed in our initial Schedule 13D filing in April 2022, we continue to engage in discussions with the Board of Directors and management concerning the Company's strategic alternatives. As a result of our belief in the prospects of the Company and its ability to unlock significant stockholder value through a strategic transaction, we filed an amendment to our Schedule 13D yesterday disclosing an increase in our already sizeable position in the Company to 9.9% of TTNP's outstanding shares. We remain hopeful that the Company's strategic review will result in a positive outcome that is in the best interest of all TTNP stockholders."
HIRRF

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07:57 EDT Hire Technologies discusses strong demand for IT professionals - HIRE Technologies discusses staffing trends driving demand for IT professionals. ProVision Staffing, HIRE's dedicated IT recruiting practice based out of Ontario, is seeing a surge in the IT recruitment sector across North America as it offers solutions to assist with staffing, recruiting, and people management. "We have been building out our people management solutions in many ways, including by expanding our footprint into the U.S. and offering Pulsify's people management platform to our new and existing client bases," said Sarah Baker, Managing Director at ProVision. "This broadening of our capabilities and regions served has allowed us to play a more critical role within our clients' teams in addition to the core recruiting and onboarding of their IT resources."
FUSN

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07:44 EDT Fusion Pharmaceuticals, Niowave announce actinium-225 supply agreement - Fusion Pharmaceuticals and Niowave, a manufacturer of medical radioisotopes from radium and uranium, announced that the companies have entered into a collaboration and supply agreement for the development, production, and supply of actinium-225. Under the agreement, Fusion will invest up to $5M in Niowave to further develop their technology to increase current production capacity of actinium-225, and in return Fusion will have guaranteed access to a pre-determined percentage of Niowave's capacity of the resulting actinium-225, as well as preferred access to any excess supply produced. As part of the agreement, Fusion will also have an option to invest in future production of actinium-225 to scale with Fusion's needs.
OSIIF

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07:35 EDT Osino Resources provides update on current drilling at THW area - Osino Resources is pleased to provide an update on current drilling at the THW area, 3km along strike to the southwest of Bulge and Twin Hills Central. THW contributed 0.23 Moz in the Inferred category to the Twin Hills Gold Project Mineral Resource Estimate published on April 13, 2022. The current drill program is designed to grow and upgrade this resource to the Indicated category. THW is structurally complex and is divided into two distinct lobes of mineralization named Oryx and Kudu, which have so far been drilled over a combined strike length of approximately 1,500m. Dave Underwood, Osino's VP Exploration, commented: "The current resource conversion drill program at THW continues to produce very promising assay results including a very high-grade shoot which has now been intersected twice returning 5m @ 10.11g/t and 7m @ 7.94g/t. The next Twin Hills Gold Project resource estimate should see an increased contribution from the THW area in terms of grade and tonnage. Mineralization is still open along strike and down dip and there is plenty of scope for new discoveries in the area which will be targeted with ongoing exploration program after the Twin Hills Gold Project PFS has been published in a few months' time." Twin Hills is an orogenic-style, sedimentary-hosted, structurally controlled gold deposit contemplated as a series of open pits, which Osino is fast-tracking through development. The THW gold discovery was first announced on December 1, 2021 and is the latest discovery in the Twin Hills cluster of resources. Since the cut-off date for drill assays used in the last MRE, a total of 21,456m of drilling from 107 holes has been completed at THW. The geology and mineralisation at THW dips southeast i.e. in the opposite direction to the mineralization at the other existing resources and therefore drillholes are orientated at 340 azimuth and 60 degrees dip.
BBIO

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07:34 EDT BridgeBio affiliate Venthera presents preliminary results from VT30 trial - BridgeBio Pharma and its affiliate company Venthera announced preliminary data from the Phase 1b trial of VT30 topical gel in patients with venous, lymphatic and mixed venolymphatic lesions of the skin, which are rare genetic vascular anomalies driven by dysregulated activation of intracellular PI3K. The data are being shared in a virtual presentation to the International Society for the Study of Vascular Anomalies. The data presented are preliminary results from an open-label, dose-finding study of VT30 topical gel in patients with cutaneous VM/LM/VLM lesions associated with mutations that result in dysregulated PI3K activation. VT30 topical gel is designed to potently inhibit PI3K in the treated tissue without systemic side effects. Early findings include: Across 15 subjects treated in escalating-dose cohorts, VT30 topical gel has been generally well-tolerated; local self-limited rash was the only adverse experience of note, occurring at an increased incidence with the highest gel concentration. All reported adverse experiences were characterized as mild to moderate. Pharmacokinetic and pharmacodynamic skin punch biopsies were taken from within the lesion. These data demonstrate that high concentrations of drug are present in the lesion at day 28 and show a reduction of pS6 in the lesion from baseline to day 28. No circulating drug was detected in plasma with any of the gel strengths studied. Based on the findings shared during ISSVA 2022, Venthera has tentatively selected the 0.6% gel for further study. Venthera is currently seeking partners to support development of VT30 topical gel in Phase 2.
ANPC

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07:32 EDT AnPac Bio regains compliance with requirements on Nasdaq Capital Market - AnPac Bio-Medical Science announced that The Nasdaq Stock Market notified the Company on June 9, 2022 that Nasdaq has determined the Company has regained compliance with the requirements to remain listed in The Nasdaq Capital Market, as required by a hearing panel's decision dated May 4, 2022, subject to a one-year Mandatory Panel Monitor of the Company's ongoing compliance with such requirements. On May 31, 2022, the Company filed a Form 6-K with the SEC, including unaudited financial statements, and referencing the receipt of proceeds from the sale of the Company's ordinary shares to certain investors in May 2022. On an adjusted basis, the Company's pro forma balance sheet reported stockholders' equity of $7,442,000, as of May 31, 2022. In addition, the Company represented in the Filing that it complies with the minimum $2.5 million stockholders' equity required for continued listing on The Nasdaq Capital Market as of the report date. Accordingly, the Company complied with the terms of the panel's decision dated May 4, 2022. Pursuant to Listing Rule 5815(d)(4)(B), the Company will be subject to a Mandatory Panel Monitor for a period of one year from June 9, 2022. If, within that one-year monitoring period, Listing Qualifications staff finds the Company again out of compliance with the requirement that was the subject of the exception, notwithstanding Rule 5810(c)(2), the Company will not be permitted to provide the Staff with a plan of compliance with respect to that deficiency and Staff will not be permitted to grant additional time for the Company to regain compliance with respect to that deficiency, nor will the company be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3). Instead, Staff will issue a Staff Delist Determination and the Company will have an opportunity to request a new hearing with the initial Hearings Panel or a newly convened Hearings Panel if the initial Hearings Panel is unavailable. The Company will have the opportunity to respond/present to the Hearings Panel as provided by Listing Rule 5815(d)(4)(C). If the hearing is unsuccessful, the Company's securities may be at that time delisted from Nasdaq.
ZLAB

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07:31 EDT Zai Lab announces breakthrough therapy designation for repotrectinib in China - Zai Lab announced that the Center for Drug Evaluation of the National Medical Products Administration granted two Breakthrough Therapy Designations for investigational repotrectinib for the treatment of patients with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and one prior line of platinum-based chemotherapy and for those with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and no chemotherapy or immunotherapy. The Breakthrough Therapy Designations for repotrectinib were supported by the data from both global and Chinese TKI-pretreated ROS1-positive NSCLC patients enrolled in the Phase 1/2 TRIDENT-1 study.
FMTX

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07:24 EDT Forma Therapeutics announces presentations at EHA 2022 Hybrid Congress - Forma Therapeutics announced its participation in the European Hematology Association, EHA, 2022 Hybrid Congress, taking place June 9-17, the Foundation for Sickle Cell Disease Research, FSCDR, Sickle Cell Disease Research and Educational Symposium and Sickle Cell Disease Scientific Meeting, held June 10-12, and the Global Congress on Sickle Cell Disease, GCSCD, held June 16-18. Forma's accepted presentations cover updated results from the open-label extension cohort of the completed Phase 1 study of etavopivat, including an analysis of the frequency and severity of pain-related adverse events, as well as the study design and key enrollment criteria of the Phase 2 Gladiolus Study of etavopivat in TD SCD, non-TD thalassemia and TD thalassemia. "We believe that data from our Phase 1 study support a highly differentiated etavopivat profile that can potentially improve the lives of patients with SCD by increasing hemoglobin levels, improving red blood cell health, and decreasing vaso-occlusive crises," said Patrick Kelly, M.D., chief medical officer. "We are pleased to have additional opportunities to share our findings and look forward to attending the upcoming meetings."
BGNE

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07:18 EDT BeiGene presents data from its hematology portfolio at EHA 2022 - BeiGene presents data from its hematology portfolio at the European Hematology Association, EHA, 2022 Hybrid Congress being held June 9-12, 2022, in Vienna, Austria. Highlights from the broad clinical program for zanubrutinib presented at EHA include: ASPEN: Long-term safety and efficacy results from the Phase 3 ASPEN trial of zanubrutinib versus ibrutinib in patients with Waldenstrom macroglobulinemia, WM, showed that, at a median follow up of 43 months, zanubrutinib continued to demonstrate clinically meaningful efficacy and a tolerable safety profile in patients with WM. ROSEWOOD: The Phase 2 ROSEWOOD trial of zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed/refractory follicular lymphoma met its primary endpoint of overall response rate and was generally well-tolerated, with safety results consistent with previous studies of both medicines. ALPINE: In the head-to-head ALPINE trial of zanubrutinib versus ibrutinib in patients with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma, those who received zanubrutinib monotherapy reported improvements in key health-related quality of life, HRQoL endpoints compared with patients who received ibrutinib monotherapy. SEQUOIA: In the SEQUOIA trial of zanubrutinib vs. bendamustine plus rituximab, zanubrutinib was associated with significant improvements in HRQoL in patients with treatment-naive CLL/SLL without del, as indicated by patient reported outcome, PRO, endpoints. The ROSEWOOD and ASPEN study findings were presented at the American Society of Cancer Oncology Annual Meeting in June 2022. BeiGene also presented two posters from proof-of-concept studies of BGB-11417, a highly selective investigational BCL2 inhibitor in CLL, non-Hodgkin's lymphoma and acute myeloid leukemia. Preliminary data from an ongoing Phase 1/1b dose-escalation and expansion study evaluating the safety, tolerability, maximum tolerated dose, and recommended Phase 2 dose of oral BGB-11417 as monotherapy or in combination with zanubrutinib, in patients with B-cell malignancies, showed promising efficacy potential for BGB-11417 and an improved safety profile, particularly in combination cohorts. Preliminary data from an ongoing Phase 1b/2 global, multi-center dose escalation and expansion study evaluating BGB-11417 plus azacytidine in patients with AML demonstrated the combination to be generally well-tolerated with the majority of complete responses observed by the end of Cycle 1.
ISEE

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07:15 EDT Iveric announces presentation of post-hoc analysis from GATHER1 trial of zimura - IVERIC bio announced a post-hoc analysis from the Zimura GATHER1 clinical trial which explored enhanced Optical Coherence Tomography, OCT, image analysis to examine the effect of Zimura on change in Ellipsoid Zone, EZ, integrity and growth of OCT-measured geographic atrophy, GA, and to examine the correlation between Fundus Autofluorescence, FAF,-measured and OCT-measured GA progression in the GATHER1 trial. The results of the post-hoc analysis showed that OCT-measured GA area strongly correlated with FAF-measured GA area, with minimal average differences in GA area between modalities. As typically used in GA clinical trials, FAF was utilized to measure GA in the GATHER1 clinical trial. A 30% reduction was observed in OCT-measured GA growth with Zimura at 12 months, which is consistent with findings using FAF-measured GA growth in GATHER1. In addition, a 22% reduction in progressive EZ loss/attenuation at 18 months was observed with Zimura compared to sham. The analyses were performed in collaboration with The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, at the Cole Eye Institute, Cleveland Clinic, and included macular cube OCT scans from the Zimura 2 mg and 4 mg groups, and sham group.
GMDA MDWD

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07:13 EDT Gamida Cell appoints Borrello to board of directors - Gamida Cell (GMDA) announces the appointment of Ivan Borrello, M.D. to its Board of Directors, effective June 9, 2022. Borrello is an Associate Professor of Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The Company also announces the resignation of Ofer Gonen from its Board of Directors, effective June 9, 2022. Gonen will be joining MediWound (MDWD) as chief executive officer effective June 30, 2022.
FULC

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07:12 EDT Fulcrum Therapeutics announces proof-of-concept data for FTX-6058 - Fulcrum Therapeutics announced clinical proof-of-concept data from the ongoing Phase 1b trial of FTX-6058 for the treatment of sickle cell disease. Initial data from the first subjects to receive a 6 mg dose of FTX-6058, an oral HbF inducer, showed a rapid and robust induction of HbF, and subjects achieved increases of up to 6.3% over baseline. HbF levels were increasing at the last measured time point, and maximal levels of HbF may have not yet been achieved. Increases in HbF have been shown to reduce the frequency or severity of a broad range of SCD symptoms, including vaso-occlusive crises, anemia, pain, infection, stroke, and others. Based on a large body of genetic, clinical, and observational evidence showing the effects of higher levels of HbF in patients with SCD, the induction of HbF by 5-10% over baseline is associated with reduced disease burden and improved clinical outcomes. These initial data showing that FTX-6058 increases HbF levels by up to 6.3% support its potential to become a transformative therapy for people living with SCD. The first cohort of the Phase 1b study has enrolled six of up to ten subjects. These six subjects received at least one 6 mg dose of FTX-6058 and all were included in the safety analyses. As of the data cut-off on May 25, 2022, three subjects were evaluable at day 28 and beyond for increases in HbF. Three subjects were not evaluated due to non-adherence or protocol deviation, as specified in the statistical analysis plan. All subjects evaluable for HbF change over baseline achieved increases in HbF by day 28. Changes in additional parameters, such as total bilirubin, reticulocyte count, and total hemoglobin were also observed, consistent with reduced hemolysis. FTX-6058 was generally well-tolerated in the initial cohort. No serious TEAEs were reported, and there were no discontinuations due to TEAEs. All non-serious TEAEs were transient and deemed unrelated to study drug.
BGNE

Hot Stocks

07:11 EDT BeiGene announces China NMPA approves tislelizumab - BeiGene announced that the China National Medical Products Administration, NMPA, has approved BeiGene's anti-PD-1 antibody, tislelizumab, in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer, NPC. "NPC is one of the most common head and neck cancers in China and many parts of Asia. Treatment options have been limited, with chemotherapy primarily provided for front-line care. On behalf of these patients, today's approval of tislelizumab, a potentially differentiated checkpoint inhibitor, for patients with recurrent or metastatic NPC could provide new hope," commented Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "We look forward to bringing this important immunotherapy to the underserved patient community in China." This approval was supported by clinical results from the randomized, double-blind, Phase 3 clinical trial RATIONALE 309 to evaluate the efficacy and safety of tislelizumab combined with gemcitabine and cisplatin versus placebo combined with gemcitabine and cisplatin as a first-line treatment for patients with recurrent or metastatic NPC.
ORN

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07:10 EDT Orion Group expands facilities maintenance platform - Orion Group announced that it has partnered with American Project & Repair, AP&R. AP&R is a leading national facilities maintenance company based in Brighton, MI. AP&R specializes in providing handyman, plumbing, electrical, and locksmith services across the U.S. and Puerto Rico. "Ted has created a unique interior service offering that prioritizes long-term relationships with service partners and advocating for customers. His industry expertise and commitment to excellence is inspiring and I am thrilled to welcome AP&R to the Orion FM platform," said Isaiah Brown, co-CEO of Orion.
COGT

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07:10 EDT Cogent Biosciences announces initial clinical data from Phase 2 APEX trial - Cogent Biosciences announced positive initial data from its ongoing Phase 2 APEX clinical trial evaluating the selective KIT D816V inhibitor bezuclastinib in patients with advanced systemic mastocytosis. The data are being presented today in a poster presentation at the 2022 European Hematology Association Congress in Vienna, Austria. APEX is a global, open-label, multi-center, two-part Phase 2 clinical trial in patients with AdvSM evaluating the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of bezuclastinib. As of the data cutoff date of May 24, 2022, 11 patients had been treated in Part 1 at one of four dose levels. The median age of patients at study entry was 70 years. Patients were enrolled with the following sub-types: two patients with aggressive systemic mastocytosis, eight patients with systemic mastocytosis with associated hematologic neoplasm, and one patient with mast cell leukemia. Two patients had received prior avapritinib and midostaurin treatment. As of the cutoff date, May 24, 2022, bezuclastinib was generally well-tolerated at all doses. The majority of adverse events were Grade 1/2 and seen in no more than one patient with one serious adverse event and no Grade 4 events reported. Grade 3 events reported as at least possibly related were anemia, neutropenia and hypersensitivity/mediator flare. There were no reported cases of periorbital/peripheral edema, cognitive effects or intracranial bleeding events, which have been associated with other KIT inhibitors. As of the cutoff date, all patients remained on study. Subsequently, one SM-AHN patient with chronic myelomonocytic leukemia transformed to acute myeloid leukemia and discontinued participation in the trial. As of the data cutoff date of May 24, 2022, all 11 patients treated were evaluated for signs of clinical activity. Eight of 11 patients had been treated for at least two cycles, had available data from bone marrow biopsy, and were evaluated for additional endpoints Cycle 3 Day 1 evaluable. 11/11 patients achieved greater than or equal to50% reduction in serum tryptase levels by central assessment; 89% median reduction in serum tryptase; Six of these patients achieved reduction to less than20 ng/mL; 8/8 patients achieved greater than or equal to50% reduction in bone marrow mast cells by central review; Six of these patients achieved complete clearance of bone marrow mast cell aggregates; 8/8 patients demonstrated decreases in KIT D816V variant allele fraction by droplet digital polymerase chain reaction; All patients remained on treatment with treatment duration ranging from 0.5 - 4.8 months. Two patients enrolled had previously received and discontinued avapritinib for toxicity reasons. Both patients have demonstrated clinical outcomes consistent with the avapritinib-naive patients, including similar magnitude reductions in serum tryptase. Based on the favorable initial safety and tolerability profile and clinical activity observed to date in the Phase 2 APEX clinical trial with bezuclastinib for AdvSM,Cogentwill continue enrolling patients in Part 1 of APEX to determine a recommended dose for use in Part 2 of the trial. A pre-planned interim analysis is scheduled once approximately 28 patients have received at least two cycles of study treatment in Part 1. Cogent plans to present additional data from APEX by the end of 2022. In addition,Cogent continues to actively enrollpatients in SUMMIT, a Phase 2 clinical trial with bezuclastinib for NonAdvSM, and PEAK, a registrational randomized, open-label, global, Phase 3 clinical trial in patients with imatinib-resistant Gastrointestinal Stromal Tumors. Cogent plans to present initial data from SUMMIT and lead-in data from PEAK in the first half 2023.
CRIS

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07:07 EDT Curis presents new findings on biomarker development for emavusertib - Curis announced the presentation of novel findings on biomarker development for IRAK4 inhibitor emavusertib, collaborative work from the University of Florida in primary CNS lymphoma, and clinical data from the TakeAim Leukemia and TakeAim Lymphoma studies at the 2022 European Hematology Association Hybrid Congress currently taking place in Vienna, Austria and online until June 12. "We are delighted to share with our colleagues in Europe our findings regarding IRAK4's previously undescribed localization in the nucleus of cancer cells. It appears that when IRAK4 is found in the nucleus with active NF-kB proteins p50 and p65, using a technique which we refer to as 'triple staining,' this triple nuclear presence is associated with better responses to emavusertib," said James Dentzer, President and CEO of Curis. "Also at EHA this year, collaborative work by Dr. Duane Mitchell's team at the University of Florida is being presented on the potential role of emavusertib in treating pCNSL, including data on one patient who achieved a complete response following previous treatment with ibrutinib," Dentzer continued. "And finally, in addition to this foundational work on IRAK4 biology, we are presenting data from our TakeAim Lymphoma and TakeAim Leukemia studies as we continue to spread the word on IRAK4 and the utility of inhibiting this important target to our European colleagues."
CYCN

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07:07 EDT Cyclerion Therapeutics announces clinical data from study of CY6463 - Cyclerion Therapeutics announced positive topline data in its signal-seeking clinical study of CY6463, for the potential treatment of Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes. Chad Glasser, Pharm.D., Director of Clinical Research at Cyclerion Therapeutics, will present results from this clinical study today during the Clinical Trial Updates Panel at the United Mitochondrial Disease Foundation Mitochondrial Medicine 2022 Symposium, taking place June 8-11, 2022, in Phoenix, Arizona. CY6463 is a positive allosteric modulator of soluble guanylate cyclase, which amplifies endogenous NO signaling, a pathway that has been linked to mitochondrial biogenesis and function. In this open-label, single-arm study of the oral, once-daily sGC stimulator in eight MELAS patients, improvements were seen across a range of biomarkers, including mitochondrial disease-associated biomarkers such as lactate and GDF-15, a broad panel of inflammatory biomarkers, cerebral blood flow, and functional connectivity between neural networks. These positive effects after 29 days of dosing were supported by correlations across several endpoints and were more pronounced in patients with greater baseline disease burden. A return toward baseline levels after discontinuation of CY6463 dosing across several biomarkers was also observed. CY6463 was well tolerated with no adverse events leading to treatment discontinuation, and pharmacokinetics were consistent with the Phase 1 study in healthy volunteers. The positive data from this study further support the potential of CY6463, the first and only CNS-penetrant sGC stimulator in clinical development, to provide therapeutic benefit to people living with MELAS. Study Highlights: The single-arm, open-label study enrolled eight participants who spanned a range of disease burden; 6 of the 8 were also taking a daily regimen of oral arginine or citrulline, precursors to nitric oxide that are current standard of care for MELAS patients. CY6463 was well tolerated; there were no reports of serious adverse events or treatment discontinuation due to adverse events. The PK profile and concentrations in the cerebrospinal fluid and plasma were consistent with exposures observed in Phase 1 healthy volunteer studies. Effects were observed across multiple domains of disease activity: Improvements in biomarkers associated with mitochondrial function including lactate and GDF-15. These changes correlated with each other and with CY6463 plasma concentrations; Improvements across a broad panel of inflammatory biomarkers; Increases in cerebral blood flow across all brain regions. These changes correlated with clinical improvement as assessed by the patient global impression of change scale; Increases in functional connectivity between brain regions and activation of occipital brain regions in response to the visual stimulus as measured by fMRI BOLD.
RNLX

Hot Stocks

07:05 EDT Renalytix announces presentation of data on KidneyIntelX testing - Deployment of Renalytix's KidneyIntelX bioprognostic testing in 1,112 adult diabetic kidney disease patients at Mount Sinai Health System demonstrated utility in driving guideline appropriate use of therapies, including SGLT-2 inhibitors and RAAS inhibitor use, and timely consultation to specialists in high-risk patients. The Mount Sinai clinical utility data was presented as a late-breaking ePoster session on June 5th at the American Diabetes Association 82nd Scientific Sessions in New Orleans. In the study, more than half of KidneyIntelX prognostic tests were ordered by primary care physicians, followed by endocrinologists. Application of guideline-based care, including therapeutics and appropriate specialist consultation, increased in proportion to reported risk of rapid progressive decline in kidney function. The breakdown of risk in the real-world evidence population was similar to what was observed in peer-reviewed, published KidneyIntelX clinical validation cohorts: High risk 13% vs. 17%; intermediate 40% vs. 37%; and low risk 46% vs 46%. In the 1,112 patients tested, KidneyIntelX re-stratified patient's risk from standard kidney function metrics and identified high risk adult patients with type 2 diabetes that were in stages 1, 2, and 3 of chronic kidney disease. Most importantly, the KidneyIntelX test helped physicians overcome the inertia seen with novel therapeutics proven to slow CKD progression and reduce associated patient cardiovascular event risk. As compared to patients who scored low risk, there were increases in use of anti-hypertensives, a 6-fold increase in the initiation of guideline-recommended treatments, and a nearly 3-fold increase in referrals to nephrologists, endocrinologists or dietitians. In the high-risk patient category, 20% of patients were referred to a specialist. Additionally, there was an increase in appropriate use of SGLT-2 inhibitor prescriptions by increased level of risk score. There are approximately 71,000 patients with type 2 diabetes and chronic kidney disease in the Mount Sinai Health System across New York City. Clinical utility study results are being prepared to be published in a peer reviewed publication in 2022. The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. KidneyIntelX is available clinically as a laboratory developed test. It has received Breakthrough Device Designation from the U.S. Food and Drug Administration and has been submitted to the FDA for De Novo marketing authorization. KidneyIntelX includes technology that was initially developed by Mount Sinai faculty. This technology has been licensed by Mount Sinai to Renalytix. Mount Sinai and a small number of Mount Sinai faculty inventors have a financial interest in Renalytix. Mount Sinai also has representation on the Renalytix Board of Directors.
CTIC

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07:04 EDT CTI BioPharma presents data from pacritinib program at EHA - CTI BioPharma announced two scientific poster presentations from the company's pacritinib clinical program at the European Hematology Association 2022 Congress, being held in Vienna, Austria, June 9-12. "Our presentations today demonstrate that full dose pacritinib achieved higher response rates and a similar, manageable safety profile compared to lower-dose ruxolitinib in patients with myelofibrosis who have moderate or severe thrombocytopenia," said Adam Craig, President and CEO of CTI BioPharma. "As the commercial launch of VONJOTM (pacritinib) in the U.S. continues to exceed our expectations, we are pleased to highlight VONJO's clinical value as a potential best in class treatment for patients with cytopenic myelofibrosis with platelet counts below 50 109/L."
NCNA

Hot Stocks

07:03 EDT NuCana announces presentation on activity of NUC-7738 - NuCana announced data to be presented at the European Hematology Association 2022 Hybrid Congress highlighting the activity of NUC-7738, a phosphoramidate transformation of 3'-deoxyadenosine, in a broad range of Acute Myeloid Leukemia cell lines. NUC-7738 has already shown promise as monotherapy in patients with solid tumors in a Phase 1/2 study and will also be combined with a PD-1 checkpoint inhibitor. The data at EHA 2022 show that NUC-7738 can suppress the expansion and survival of AML cells by reducing beta-catenin signaling, a key pathway in AML. NUC-7738's effect was observed in multiple different AML cell lines suggesting broad therapeutic potential. Furthermore, it was observed that NUC-7738 resulted in a reduction of the cells that are resistant to standard chemotherapy drugs and thought to be responsible for disease relapse. These findings, combined with the anti-cancer activity and favorable safety profile of NUC-7738 observed in the NuTide:701 study provide a strong rationale for the evaluation of NUC-7738 in patients with leukemia.
CLEU

Hot Stocks

07:02 EDT China Liberal Education to acquire Oriental Wisdom Cultural Development Co. - China Liberal Education announced that on June 9, the company, through its wholly-owned subsidiary, China Liberal Education Technology Co., Ltd., entered into a definitive stock purchase agreement with Beijing Cloud Class Technology Co., Ltd. to acquire from Cloud Class 100% of the issued equity interests of Beijing Oriental Wisdom Cultural Development Co., Ltd., an integrated education service provider focusing on operating jointly-managed academic programs in the vocational higher education industry in China. This acquisition is a critical initiative of the company's business strategy of boosting the Company's development in the vocational education industry through integrating enterprises and developing vocational education across various industries. Pursuant to the Agreement, China Liberal Beijing agrees to acquire 100% of the equity interests of Oriental Wisdom from Cloud Class in consideration of 7M ordinary shares of the company, subject to certain payment schedules set forth in the Agreement. The transaction contemplated by the Agreement has been approved by the company's board of directors at a special meeting on June 1, with the closing expected to occur near the end of June.
EYPT

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07:02 EDT EyePoint to present 12-month results from Phase 1 DAVIO trial - EyePoint Pharmaceuticals announced that a late-breaking abstract highlighting 12-month data from the Phase 1 DAVIO clinical trial evaluating EYP-1901 for the treatment of wet age-related macular degeneration has been selected for presentation at the American Society of Retinal Specialists 2022 Annual Meeting to be held in New York City from July 13 - 16, 2022. The Phase 1 DAVIO trial is an open-label, dose escalation clinical trial of EYP-1901 that enrolled 17 patients with previously treated wet AMD. EYP-1901 is an investigational sustained delivery anti-VEGF treatment utilizing a bioerodible formulation of EyePoint's Durasert drug delivery technology that has been used in four FDA-approved products, including EyePoint's YUTIQ for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
ALTR

Hot Stocks

06:49 EDT Altair announces pricing of offering of $200M convertible senior notes - Altair announced the pricing of $200 million aggregate principal amount of Convertible Senior Notes due 2027 in a private offering to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Altair also granted the initial purchaser of the notes a 13-day option to purchase up to an additional $30 million aggregate principal amount of notes. The sale of the notes to the initial purchaser is expected to settle on June 14, 2022, subject to customary closing conditions, and is expected to result in approximately $194.6 million in net proceeds to Altair after deducting the initial purchaser's discounts and commissions and estimated offering expenses payable by Altair. The notes will be senior, unsecured obligations of Altair. The notes will bear interest at a rate of 1.750% per year, payable semi-annually in arrears on June 15 and December 15 of each year, beginning on December 15, 2022. The notes will mature on June 15, 2027 unless earlier repurchased, redeemed or converted. Altair may not redeem the notes prior to June 20, 2025. Altair may redeem for cash all or, subject to certain limitations, any portion of the notes, at its option, on or after June 20, 2025 if the last reported sale price of Altair's Class A Common Stock has been at least 130% of the conversion price then in effect for at least 20 trading days during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which Altair provides notice of redemption, at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. The notes will be convertible at an initial conversion rate of 13.9505 shares of Altair's Class A Common Stock, per $1,000 principal amount of notes. Prior to the close of business on the business day immediately preceding December 15, 2026, the notes will be convertible at the option of the noteholders only upon the satisfaction of specified conditions and during certain periods. On or after December 15, 2026 until the close of business on the business day immediately preceding the maturity date, the notes will be convertible at the option of the noteholders at any time regardless of these conditions. Upon conversion, Altair will satisfy its conversion obligation by paying and/or delivering, as the case may be, cash, shares of its Class A Common Stock or a combination of cash and shares of its Class A Common Stock, at Altair's election. Altair intends to use approximately $192.4 million of the net proceeds from the offering to repurchase approximately $148.2 million aggregate principal amount of Altair's 0.250% Convertible Senior Notes due 2024 in the repurchase transactions described below and to use the remainder of the net proceeds for working capital and other general corporate purposes, which may include potential acquisitions and strategic transactions as well as repurchases of its Class A Common Stock. From time to time, Altair evaluates potential acquisitions and strategic transactions of businesses, technologies, or products. However, Altair has not designated any specific uses and has no current agreements with respect to any material acquisition or strategic transaction. Altair's intentions with respect to its use of such net proceeds are subject to change. Contemporaneously with the pricing of the notes, Altair entered into separate privately negotiated transactions with certain holders of the 2024 notes to repurchase approximately $148.2 million aggregate principal amount of the 2024 notes for an aggregate of approximately $192.4 million of cash. Altair expects that certain holders of 2024 notes that agreed to sell their 2024 notes in negotiated transactions with Altair will, concurrently with or shortly after the pricing of the notes, enter into or unwind various derivatives with respect to Altair's Class A Common Stock and/or purchase shares of Altair's Class A Common Stock in the market. The amount of Altair's Class A Common Stock that such holders purchase may be substantial in relation to the historic average daily trading volume of Altair's Class A Common Stock. In addition, Altair expects that certain purchasers of the notes may establish a short position with respect to Altair's Class A Common Stock by short selling Altair's Class A Common Stock or by entering into short derivative positions with respect to Altair's Class A Common Stock, in each case, in connection with the offering.
CEIX

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06:47 EDT Consol Energy releases 2021 Corporate Sustainability Report - CONSOL Energy announced the release of its 2021 Corporate Sustainability Report, "ESG-i: Innovating for Tomorrow." The report is CONSOL's fifth since becoming an independent, publicly listed company in 2017 and pinpoints innovation as integral to the Company's strategy and ESG management approach. The report provides an update of the Company's efforts to advance its Forward Progress sustainability initiative in 2021, including: Pennsylvania Mining Complex employees achieving a total recordable incident rate of 2.25, or 53% below Mine Safety and Health Administration industry averages for the underground bituminous coal mining industry; Maintaining an environmental compliance record exceeding 99.9% for the ninth consecutive year, as measured by the rate of compliance with permit effluent limits; and Achieving record water reuse volumes, with 721 million gallons of water recycled for use in operations. Additionally, the report highlights the Company's continued efforts under CONSOL's Forward Progress sustainability initiative, including its previously announced direct operating greenhouse gas emission reduction targets and the Company's technology endeavors, which include multiple U.S. Department of Energy sponsored projects seeking to develop alternative uses for coal and advance GHG emissions control technologies.
LAZ

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06:46 EDT Lazard reports preliminary AUM $236B as of May 31 - Lazard reported that its preliminary assets under management as of May 31 totaled approximately $236B. The month's AUM included foreign exchange appreciation of $1.4B, market depreciation of $1.1B, and net outflows of $1B.
JAGGF

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06:36 EDT Jaguar Mining announces normal course issuer bid - Jaguar Mining announces that the Toronto Stock Exchange has accepted Jaguar's notice to make a normal course issuer bid to purchase for cancellation up to 3,623,640 common shares in the capital of the Company in total, being 5% of the issued and outstanding Common Shares as at the date of Jaguar's notice to the TSX, to be transacted through the facilities of the TSX. The actual number of Common Shares that may be purchased pursuant to the Bid will be determined by management of the Company. The Bid will commence on June 15, 2022 and will terminate on June 14, 2023, or such earlier time as the Bid is completed or terminated at the option of Jaguar. Purchases pursuant to the Bid will be made by Pollitt & Co. Inc. on behalf of the Company. Decisions regarding the timing of purchases under the Bid will be determined by Management based on market conditions, share price and other factors. Management may elect to not purchase any Common Shares under the Bid, or may elect to suspend or discontinue the Bid at any time. Any purchases pursuant to the Bid will be financed from the working capital of Jaguar. In accordance with the rules of the TSX governing normal course issuer bids, the total number of Common Shares the Company is permitted to purchase is subject to a daily purchase limit of 22,395 Common Shares, representing 25% of the average daily trading volume of Common Shares on the TSX calculated for the six-month period ended May 31, 2022, being approximately 89,581 Common Shares. However, the Company may make one block purchase per calendar week which exceeds the daily repurchase restriction. The price that Jaguar will pay for any Common Shares under the Bid will be the prevailing market price on the TSX at the time of such purchase. The Board of Directors of Jaguar believes that the underlying value of the Company may not be accurately reflected at times in the market price of the Common Shares. Accordingly, the purpose of the Bid is to enhance long-term shareholder value through the purchase and cancellation of Common Shares at a discount to the underlying value of the Company. Furthermore, the purchases by Jaguar will help mitigate the dilutive effects of any future potential issuances of additional Common Shares as consideration for capital raises, joint ventures or asset acquisitions.
FEDU

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06:35 EDT Four Seasons Education announces change to ADS ratio - Four Seasons Education announced that it will change the ratio of its American depositary shares representing its ordinary shares from two ADSs representing one ordinary share to one ADS representing ten ordinary shares. For Four Seasons Education's ADS holders, the change in the ADS ratio will have the same effect as a one-for-twenty reverse ADS split. There will be no change to the Company's underlying ordinary shares, and no ordinary shares will be issued or cancelled in connection with the change in ADS ratio. The Company will file a post-effective amendment to its registration statement on Form F-6 with the United States Securities and Exchange Commission to reflect the change in the ADS ratio. The effect of the ratio change on the Company's ADS trading price on the New York Stock Exchange is expected to take place on or about June 21, 2022. Each ADS holder of record at the close of business on the date when the change in the ADS ratio is effective will be required to surrender their ADSs to the Company's depositary bank, Deutsche Bank Trust Company Americas, for cancellation and exchange in the ratio of every twenty existing ADSs for one new ADS. Four Seasons Education's ADSs will continue to be traded on the NYSE under the symbol "FEDU".
SECO

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06:34 EDT Secoo to build up Black Card service system - Secoo Group has made an official announcement that it will build up a Black Card service system concerning exquisite lifestyle--to turn its high-end users into its spokesman. According to Bain& Company's annual China Luxury Report 2021, despite mounting global social and economic challenges, China's Luxury goods mainland market finished 2021 with strong double-digit growth overall, with some brands exceeding a 70% increase. Even though China market has reached a high level of digitization and continues to grow, the report forecasts that the online sales of China market's person luxury goods will increase approximately by 56%. It shows that the most concerned China's high-end users of luxury goods has shifted from offline consumption to online consumption due the epidemic outbreak. On top of that, consumers use to be influenced by others when they make luxury goods purchase decision and now they tend to be more rational. A newly-released report by Bain&Company Unpacking Asia-Pacific Consumers' New Love Affair With Sustainability suggests that 90% of the respondents of a survey of 16,000 consumers in Asia-Pacific countries are willing to pay for products' sustainability and 40% of the respondents show willingness to increase their budgets on sustainable products in next 3 years. In consideration of the needs of high-end users, Secoo has launched its Black Card service system concerning exquisite lifestyle. Nevertheless, the services provided is not standardized, instead, it's personalized and customized luxury service. Based on the personalized demands, Secoo will tailor the high-end customized service for users by providing both online and offline services. Experts, buyers and consultants from various high-end areas of life will provide the most detailed services and experiences for its users covering life modes and scenes.
CDXC

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06:33 EDT ChromaDex signs distribution agreement with Sinopharm Xingsha - ChromaDex announced a signed distribution agreement with Sinopharm Xingsha to accelerate cross-border sales of Tru Niagen into mainland China. Tru Niagen features ChromaDex's proprietary Niagen ingredient, which is the world's most efficient NAD+ precursor on the market, particularly over NMN. Sinopharm Xingsha is the main platform of Sinopharm Group for food supplements and healthcare products and is a subsidiary of Sinopharm Group, with businesses including pharmaceutical manufacturing, marketing and distribution of drugs, and food supplements and healthcare products. Sinopharm Group is a large healthcare group directly under the State-owned Assets Supervision and Administration Commission of the State Council, with a full value chain in the industry covering R&D, manufacturing, logistics and distribution, retail chains, healthcare, engineering services, exhibitions and conferences, international business, and financial services. In line with ChromaDex's recent China Joint Venture announcement, Sinopharm Xingsha will collaborate to secure Health Food Registration in China.
MTDR

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06:31 EDT Matador announces intention to double quarterly dividend to 10c per share - Matador Resources announced that its Board of Directors amended the company's dividend policy pursuant to which the company intends to pay quarterly cash dividends on its common stock of 10c per share, which is an increase from its prior policy of 5c per share initiated in October 2021. The company anticipates that the Board will implement such amended policy in connection with the declaration of its next quarterly dividend, which is expected during the third quarter.
KROS

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06:22 EDT Keros Therapeutics reports results from KER-050 Program - Keros Therapeutics announced that it presented additional data from its ongoing Phase 2 clinical trial of KER-050 in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes, as well as preclinical data on the differentiated mechanism of action of KER-050 and its activity on multiple stages of thrombopoiesis, at the 27th Annual Congress of the European Hematology Association, held in person and virtually June 9 through 17, 2022. In addition, Keros announced preclinical data evaluating ALK2 inhibition as a potential treatment option for anemia of inflammation. "We believe the additional data from our ongoing Phase 2 clinical trial of KER-050 in MDS patients continues to support the potential of KER-050 as a treatment for multilineage cytopenias, and are pleased to present at EHA this year," said Jasbir S. Seehra, Ph.D., President and CEO of Keros. "Additionally, we are excited to announce that we have recently initiated dosing for Part 2 of the trial, at a starting dose of 3.75 mg/kg, with an opportunity for patients to dose escalate to 5.0 mg/kg based on individual titration rules, following the Safety Review Committee recommendation for this trial." Sustained increases in platelets were observed in HTB patients achieving HI-E or TI, which supports the potential of KER-050 as a treatment for multilineage cytopenias in difficult-to-treat HTB patients. Increases in reticulocytes and serum soluble transferrin receptor levels, as well as decreases in serum ferritin, were also observed in HTB patients. Together, these exploratory pharmacodynamic data suggest an improvement in erythropoiesis. As of the data cut-off date, KER-050 was observed to be generally well-tolerated in the 31 patients in Cohorts 1 through 5 who had received at least one dose of KER-050. No drug-related serious adverse events or dose-limiting toxicities were reported. The most commonly reported treatment-emergent adverse events were dyspnea, fatigue, anemia, diarrhea, headache and nausea. Treatment-related adverse events were reported in five patients, which were mild or moderate in severity. No patients developed acute myeloid leukemia. Four patients withdrew from the trial prior to completing treatment with KER-050, one due to death deemed unrelated to study drug, one due to withdrawn consent and two due to unrelated treatment-emergent adverse events. Following recommendation by the Safety Review Committee, dosing for Part 2 of the trial was initiated at a starting dose of 3.75 mg/kg, with an opportunity for patients to dose escalate to 5.0 mg/kg based on individual titration rules.
RHHBY

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06:16 EDT Roche reports 'positive' data from blood cancer portfolio at EHA - Five-Year Results of Phase III CLL14 Study of Venclexta Plus Gazyva: After a median of 65.4 months following treatment with Venclexta plus Gazyva, results confirm the combination continues to be an effective fixed-duration and chemotherapy-free option for patients with previously untreated CLL and coexisting conditions. The estimated investigator-assessed progression-free survival rate at this follow-up was 62.6% with Venclexta plus Gazyva and 27.0% with Gazyva plus chlorambucil, and the estimated overall survival rate was 81.9% versus 77.0%. In addition, the analysis found that 72.1% of patients in the Venclexta plus Gazyva arm did not require another treatment for CLL in the five years following initial treatment. No new safety signals were observed. The CLL14 study is being conducted in cooperation with the German CLL Study Group, headed by Michael Hallek, M.D., University of Cologne. Final Analysis of Phase III GALLIUM Study of Gazyva: After eight years of follow-up in people with previously untreated FL, a meaningful improvement in PFS was maintained with Gazyva plus chemotherapy, confirming its role as a standard of care for first-line treatment. Seven-year investigator-assessed PFS was significantly improved with Gazyva plus chemotherapy compared with Rituxan plus chemotherapy. This translated into a longer time to next anti-lymphoma treatment. At seven years, 74.1% of patients receiving Gazyva plus chemotherapy had not started new anti-lymphoma therapy compared to 65.4% receiving Rituxan plus chemotherapy. The incidence of serious adverse events was 48.9% with Gazyva plus chemotherapy and 43.4% with Rituxan plus chemotherapy. Subgroup Analyses of Pivotal Phase III POLARIX Study: Exploratory subgroup analyses of the Phase III POLARIX study of Polivy with R-CHP compared to the current standard of care, Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone, in people with previously untreated DLBCL further support the potential for Polivy to transform the standard of care for people with this aggressive type of lymphoma. One of the datasets being presented is an analysis of study participants from Asia. Among this subgroup, results showed a significant improvement in PFS with Polivy plus R-CHP versus R-CHOP, reducing the risk of disease progression, relapse or death by 36%. The safety profile was generally comparable for both regimens. Based on the positive POLARIX results from the overall study population, the European Commission approved Polivy plus R-CHP in May 2022 for the treatment of adult patients with previously untreated DLBCL.
CRBU

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06:12 EDT Caribou Biosciences presents data from ANTLER Phase 1 trial for CB-010 - Caribou Biosciences announced the presentation of additional initial clinical data from its ANTLER Phase 1 trial for CB-010 in patients with relapsed or refractory B cell non-Hodgkin lymphoma. Following a single dose at the initial dose level of CB-010, a 100% complete response rate was observed as best response. At 6 months following the single dose of CB-010, 40% of patients remained in CR as of the May 13, 2022 data cutoff date. The data are being presented at the European Hematology Association 2022 Hybrid Congress, being held in Vienna, Austria, June 9-17, 2022. "The preliminary safety and efficacy results are promising. All six patients treated with CB-010 at the initial dose level of 40 million CAR-T cells achieved a complete response, and we are now enrolling dose level 2 and look forward to seeing this study mature," said Loretta J. Nastoupil, M.D., associate professor, Department of Lymphoma/Myeloma in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center and the presenting investigator on the ANTLER trial. "CB-010 was generally well-tolerated and the adverse events observed are consistent with autologous or allogeneic CAR-T cell therapies."
APLS

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06:10 EDT Apellis, Sobi present data reinforcing efficacy, safety profile of EMPAVELI - Apellis Pharmaceuticals and Sobi reported new analyses of Phase 3 studies that reinforce the robust efficacy and safety profile of EMPAVELI/Aspaveli for paroxysmal nocturnal hemoglobinuria. The data will be presented at the hybrid European Hematology Association Congress in Vienna, Austria. New analyses demonstrated that treatment with EMPAVELI resulted in meaningful improvements in quality of life for treatment-naive patients and suggested the incidence of thrombosis was comparable to eculizumab, a C5 inhibitor. Additionally, a matching-adjusted indirect comparison showed significant improvements in clinical outcomes in treatment-naive patients who received EMPAVELI compared to C5 inhibitors. "The data presented at EHA add to a growing body of evidence, which shows that EMPAVELI leads to both clinically meaningful efficacy and improved quality of life regardless of prior treatment," said Peter Hillmen, M.B. Ch.B., Ph.D., head of hematology engagement at Apellis. "Many patients experience a significant disease burden, even with C5 inhibitor treatment, so these data further emphasize that EMPAVELI has the potential to become a new standard of care for PNH."
GBT

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06:08 EDT Global Blood Therapeutics presents data supporting use of Oxbryta - Global Blood Therapeutics announced new data from a large multicenter real-world evidence study supporting the clinical use of Oxbryta for the treatment of sickle cell disease in patients 12 years of age and older. In addition, Phase 1 data of GBT021601, the company's next-generation sickle hemoglobin polymerization inhibitor, support its progression into the Phase 2 portion of a Phase 2/3 trial that is anticipated to commence by mid-year. These data, as well as new research from the United Kingdom demonstrating that an improvement of anemia as measured by hemoglobin reduces the risk of end-organ damage in SCD patients, will be presented at the European Hematology Association 2022 Hybrid Congress from June 9-12, 2022 in Vienna, Austria and online. "At EHA2022 this week, we presented data from the first multicenter retrospective study of SCD patients treated with Oxbryta in a real-world setting, which demonstrated the positive clinical impact of Oxbryta - results that were consistent with the pivotal Phase 3 HOPE Study. In addition, our study in the U.K. of the impact of the improvement of anemia adds to the growing body of data that supports the need to maximize hemoglobin levels in sickle cell patients in order to help protect against end-organ damage," said Ted W. Love, M.D., president and chief executive officer of GBT. "As more clinicians gain experience with Oxbryta and we build on our recent regulatory approvals by the European Commission and in the Middle East, we're very pleased with our progress on making this transformative, first-in-class therapy available to more patients around the world."
NGVC

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06:06 EDT Natural Grocers partners with Solaray for Bean Trailer give away - Natural Grocers. is partnering with Solaray to give away a limited-edition customized Solaray Bean Trailer. The chance to win the prize coincides with the introduction of Solaray's new High Potency Liposomal Multivitamins, now available at Natural Grocers stores, nationwide.
COTY

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06:05 EDT Coty announces intention to gradually recommence shareholder returns - Coty announced its intention to gradually return its Equity distributions as deleveraging continues, while also entering into agreements with several banks to start hedging a planned $200M share buyback program in calendar 2024. Having made substantial progress in lowering its leverage from ~7x exiting FY21 to 4.7x exiting 3Q FY22, or approximately 3.6x when factoring in the value of its retained 26% stake in Wella, Coty anticipates continued strong free cash flow generation and steady deleveraging progress in the coming years. As Coty progresses on its trajectory to reach its targeted leverage of approximately 2x by calendar 2025, this will open opportunities for Coty to gradually recommence shareholder distributions, within the scope of the Ccompany's financial policy. Coty has therefore entered into total return swaps in respect of its Class A Common Stock with several banks to hedge its potential exposure at around prevailing stock price trading levels over the applicable hedging periods for a planned $200M share buyback program. Any total return swap settled in shares would be covered by the company's existing share repurchase authorization.
NUTX USPH

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06:04 EDT Nutex Health appoints Jon Bates as CFO - Nutex Health (NUTX) announced the appointment of Jon Bates as the Company's CFO effective on or about June 30, 2022. On May 3, 2022, Michael Bowen notified the company that he intends to retire as CFO of the Company. In connection with Mr. Bowen's retirement, the Company's Board formed a search committee. On June 8, 2022, the Company announced the appointment of Jon Bates as the Company's new CFO, effective on or about June 30, 2022. Mr. Bowen will remain employed with the Company for the purpose of providing transition and other consulting services for an additional twelve months. Since 2006, Bates has served as Vice President of Accounting and Corporate Controller at U.S. Physical Therapy, Inc. (USPH).
AMRN

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06:03 EDT Amarin: UK's NICE recommends reimbursement, use of VAZKEPA - Amarin announces that the UK's National Institute for Health and Care Excellence is recommending icosapent ethyl, marketed under the brand name VAZKEPA, for reimbursement and use across the National Health Service in England and Wales to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk who have elevated triglycerides, LDL-C levels greater than1.04 mmol/L, and established cardiovascular disease, at a price of GBP 144.21 per 120 soft capsules.
IMOS

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06:02 EDT ChipMOS reports May revenue of $82.7M vs. $80.7M last year - ChipMOS TECHNOLOGIES reported its unaudited consolidated revenue for the month of May 2022. Revenue for the month of May 2022 was NT$2,396.7 million or $82.7M, an increase of 2.5% compared to May 2021 and an increase of 2.2% compared to April 2022. The Company noted its record May revenue was the result of a combination of sustained demand and favorable dynamics in its memory products and DDIC businesses.
IMGO

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05:57 EDT Imago BioSciences reports 'positive' data from Phase 2 study of bomedemstat - Imago BioSciences presented updated positive data from its ongoing global Phase 2 clinical study evaluating bomedemstat in patients with essential thrombocythemia. Updated Highlights: Enrollment completed with 73 patients in April 2022. Of the 32 patients treated with bomedemstat for more than 24 weeks: 97% achieved platelet count reduction to less than or equal to400 x 109/L. 94% achieved platelet count reduction to less than or equal to400 x 109/L with no thromboembolic events, the primary efficacy endpoint of this study. 81% of patients achieved a durable response, defined as platelet count of less than or equal to400 x 109/L for at least 12 weeks. Of the 31 patients with Total Symptom Score data available at 24 weeks: 58% showed a decrease in TSS. 32% showed improvements greater than or equal to10 points, one component of the ELN criteria for response. Importantly, platelet response rates were similar across all genotypes identified in the study. Additionally, 67% patients demonstrated a net decrease in mutation allele frequencies including both CALR and JAK2.
ABBV

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05:54 EDT AbbVie reports five-year follow-up results from Phase 3 CLL14 trial - AbbVie announced five-year follow-up results from the Phase 3 CLL14 trial, finding that over 60% of patients with previously untreated chronic lymphocytic leukemia who had received one-year fixed-duration combination treatment of VENCLYXTO/VENCLEXTA plus obinutuzumab continued to show longer progression-free survival and higher rates of undetectable minimal residual disease after four years off treatment. The findings were presented at the 2022 European Hematology Association Annual Congress.
ABBV

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05:52 EDT AbbVie presents new data from Cohort 3 of Phase 2 REFINE study - AbbVie announced new data from Cohort 3 of its Phase 2 REFINE study of investigational navitoclax in combination with ruxolitinib in JAK inhibitor naive patients with myelofibrosis, a rare and difficult to treat blood cancer. These preliminary findings show spleen volume and symptomatic improvement in this cohort. These data are consistent with previously observed data from relapsed/refractory patients in Cohort 1a1 and will be shared in an oral presentation at the 2022 European Hematology Association Annual Congress. REFINE is a Phase 2 non-randomized open-label multi-cohort study evaluating the safety and efficacy of navitoclax alone or in combination with ruxolitinib in MF.
TAC

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05:50 EDT Appeals Court upholds TransAlta's favorable force majeure arbitration decision - TransAlta announced that the Alberta Court of Appeal released a unanimous decision dismissing an application filed by ENMAX Energy Corporation and the Balancing Pool seeking to set aside an arbitration decision in favor of TransAlta. The Court of Appeal upheld the company's claim of force majeure that arose when its Keephills 1 generating unit tripped off-line in 2013. As a result of the decision, the company's claim of force majeure remains valid and the associated costs of the force majeure event will not be reassessed against TransAlta.
CPA

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05:48 EDT Copa Holdings reports preliminary May traffic down 4.2%, capacity down 3.7% - Load factor was down 0.4 p.p. Given the irregular nature of the company's operations starting in March 2020 due to the Covid-19 pandemic, this traffic report will compare to 2019 statistics. Consolidated capacity came in 3.7% lower than May 2019, while passenger traffic decreased 4.2%, which resulted in an 85.7% load factor.
GSK

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05:47 EDT GSK says RSV vaccine candidate showed significant efficacy in Phase III trial - GSK plc announced headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial. The interim analysis was reviewed by an Independent Data Monitoring Committee, and the primary endpoint was exceeded with no unexpected safety concerns observed. AReSVi 006 is a phase III trial investigating GSK's respiratory syncytial virus vaccine candidate for adults aged 60 years and above. Hal Barron, Chief Scientific Officer and President, R&D, GSK, said: "These data suggest our RSV vaccine candidate offers exceptional protection for older adults from the serious consequences of RSV infection. RSV remains one of the few major infectious diseases without a vaccine, and these data have the potential to meaningfully impact the treatment of RSV and may reduce the 360,000 hospitalisations and more than 24,000 deaths worldwide each year. Given the importance of these data, we plan to engage with regulators immediately and anticipate regulatory submissions in the second half of 2022." Results from this phase III trial will be presented in a peer-reviewed publication and at an upcoming scientific meeting. The AReSVi 006 trial will continue to evaluate both an annual revaccination schedule and longer-term protection over multiple seasons following one dose of the RSV older adult vaccine candidate.