Stockwinners Market Radar for May 31, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
TWLO | Hot Stocks20:10 EDT Cathie Wood's ARK Investment bought 51.2K shares of Twilio today
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MCK | Hot Stocks19:32 EDT McKesson CFO sells $9.1M in common stock - In a regulatory filing, McKesson disclosed that its CFO Britt Vitalone sold 27.3K shares of common stock on May 27th in a total transaction size of $9.1M.
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HPQ | Hot Stocks18:49 EDT HP Inc. CEO: Supply chain situation continues to be challenging - In an interview on CNBC's Mad Money, Enrique Lores said HP had a very strong performance in its PC business. "We see hybrid work as a great opportunity for us to grow in the future," he added. The company's print performance was driven by supply, and it's looking to gain back lost market share. Lores is "confident" in 2H22.
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POAHY... | Hot Stocks18:37 EDT Eve Holding partners with Porsche consulting on eVTOL strategy - Eve Holding (EVEX), a carve-out from Embraer (ERJ), announced that it has chosen Porsche Consulting to help define the eVTOL supply chain, global manufacturing and logistics macro strategy. Considering advanced manufacturing research and innovation, the companies will combine their aeronautic and automotive expertise to support Eve's implementation plan. The master services agreement that has been entered into by and between the companies includes studies on industrial operation, logistics, supply chain and parts distribution in an unprecedented approach optimized for efficiency, productivity and safety.
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CRM | Hot Stocks18:24 EDT Salesforce co-CEO Benioff: It was a remarkably healthy quarter - In an interview on CNBC's Mad Money, Marc Benioff said the company's pipeline is strong for the rest of the year. There were many exciting customer wins in Q1 and large clients are extending contracts, he noted. The company's FY23 guidance was impacted by foreign exchange, he added.
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KYMR | Hot Stocks18:11 EDT Kymera's treatment of Peripheral T-cell Lymphoma granted orphan designation - According to a post on the FDA's website, Kymera Therapeutics' treatment of Peripheral T-cell Lymphoma was granted orphan designation. Reference Link
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APPN | Hot Stocks17:54 EDT Appian institutional holder Abdiel Capital buys $3.89M in common stock - In a regulatory filing, Appian disclosed that one of its top institutional holders, Abdiel Capital, bought 81.8K shares of common stock on May 26th in a total transaction size of $3.89M. Shares of Appian are up 4.7% at $50.00 afterhours.
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RIVN | Hot Stocks17:44 EDT Rivian Automotive director buys $1.17M in common stock - In a regulatory filing, Rivian Automotive disclosed that its director Jay Flatley bought 40K shares of common stock on May 26th in a total transaction size of $1.17M.
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SAVE... | Hot Stocks17:23 EDT Spirit Airlines disagrees with ISS recommendation on proposed deal with Frontier - Spirit Airlines (SAVE) commented on a report from Institutional Shareholder Services regarding the company's definitive merger agreement with Frontier Group Holdings (ULCC), parent company of Frontier Airlines. "We disagree with ISS' recommendation against the Frontier-Spirit merger, which we continue to believe is in the best interest of Spirit stockholders. ISS appears overfocused on the absence of a reverse termination fee in that deal, and we have consistently maintained, as ISS also acknowledges, that the JetBlue (JBLU) proposal carries significantly greater regulatory obstacles, and JetBlue absolutely should pay Spirit stockholders more to compensate for that risk," said Ted Christie, President and CEO of Spirit. "During the extensive discussions held between Spirit and JetBlue, JetBlue admitted that a lawsuit from DOJ seeking to block a merger with Spirit was a 100% certainty; therefore, JetBlue would have to prevail in or settle DOJ litigation in order to consummate the deal. Moreover, ISS did not recognize the elevated business disruption that Spirit would face from a lengthy review and litigation process ultimately resulting from a failed transaction with JetBlue after 18-24 months, nor did it adequately weigh the loss of substantial value Spirit stockholders otherwise would have received in a merger between Spirit and Frontier. We continue to believe the reverse termination fee is a moot point because there is nothing stopping JetBlue from walking away after achieving their goal of disrupting the Spirit-Frontier combination. Further, we disagree with ISS' characterization that stockholders can reinvest the cash proceeds from a JetBlue transaction to maintain exposure to the airline industry recovery. Spirit stockholders would not receive $30 of cash per share for up to two years, if ever, during which time the airline industry recovery may have delivered value for stockholders that far exceeds JetBlue's capped, inadequate and highly opportunistic offer. In contrast, the Frontier combination presents a compelling value creation opportunity due to the combination of cash and stock consideration, which gives our stockholders the chance to participate in the upside of the post-pandemic recovery in the airline industry upon close and benefit from up to $500 million in annual run-rate operating synergies. ISS also recommends Spirit stockholders do not vote JetBlue's proxy card, indicating ISS still sees a potential path forward for Spirit to merge with Frontier. Overall, we ask our stockholders not to be distracted by JetBlue's highly conditional tender offer, and our Board continues to unanimously recommend that Spirit stockholders vote FOR the merger proposal with Frontier," said Christie.
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SAVE ULCC | Hot Stocks17:21 EDT Spirit Airlines disagrees with ISS recommendation on proposed deal with Frontier - Spirit Airlines (SAVE) commented on a report from Institutional Shareholder Services regarding the company's definitive merger agreement with Frontier Group Holdings (ULCC), parent company of Frontier Airlines. "We disagree with ISS' recommendation against the Frontier-Spirit merger, which we continue to believe is in the best interest of Spirit stockholders. ISS appears overfocused on the absence of a reverse termination fee in that deal, and we have consistently maintained (as ISS also acknowledges) that the JetBlue proposal carries significantly greater regulatory obstacles, and JetBlue absolutely should pay Spirit stockholders more to compensate for that risk," said Ted Christie, President and CEO of Spirit. "During the extensive discussions held between Spirit and JetBlue, JetBlue admitted that a lawsuit from DOJ seeking to block a merger with Spirit was a 100% certainty; therefore, JetBlue would have to prevail in or settle DOJ litigation in order to consummate the deal. Moreover, ISS did not recognize the elevated business disruption that Spirit would face from a lengthy review and litigation process ultimately resulting from a failed transaction with JetBlue after 18-24 months, nor did it adequately weigh the loss of substantial value Spirit stockholders otherwise would have received in a merger between Spirit and Frontier. We continue to believe the reverse termination fee is a moot point because there is nothing stopping JetBlue from walking away after achieving their goal of disrupting the Spirit-Frontier combination. Further, we disagree with ISS' characterization that stockholders can reinvest the cash proceeds from a JetBlue transaction to maintain exposure to the airline industry recovery. Spirit stockholders would not receive $30 of cash per share for up to two years, if ever, during which time the airline industry recovery may have delivered value for stockholders that far exceeds JetBlue's capped, inadequate and highly opportunistic offer. In contrast, the Frontier combination presents a compelling value creation opportunity due to the combination of cash and stock consideration, which gives our stockholders the chance to participate in the upside of the post-pandemic recovery in the airline industry upon close and benefit from up to $500 million in annual run-rate operating synergies. ISS also recommends Spirit stockholders do not vote JetBlue's proxy card, indicating ISS still sees a potential path forward for Spirit to merge with Frontier. Overall, we ask our stockholders not to be distracted by JetBlue's highly conditional tender offer, and our Board continues to unanimously recommend that Spirit stockholders vote FOR the merger proposal with Frontier," said Christie.
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LMT | Hot Stocks17:15 EDT Lockheed Martin awarded $185.69M Navy contract modificaiton - Sikorsky Aircraft, a Lockheed Martin company, was awarded an $185.69M fixed-price incentive firm modification to a previously awarded contract. This modification adds scope to procurement and delivery of two unfunded priority list CH-53K Heavy Lift Aircraft under low rate initial production Lot six. Work is expected to be completed in December 2025. FY22 aircraft procurement funds in the amount of $185.69M will be obligated at the time of award, none of which will expire at the end of the current fiscal year. The Naval Air Systems Command is the contracting activity.
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LPI | Hot Stocks17:02 EDT Laredo Petroleum announces $200M share repurchase program - Laredo Petroleum announced that its board of directors authorized a $200M share repurchase program. The two-year program is authorized through May 27, 2024. Highlights: $200M share repurchase program realizes the company's commitment to begin returning significant cash to shareholders approximately nine months ahead of schedule; Debt repayment target updated to ~$700M by year-end 2023; On track to achieve targeted Net Debt/Consolidated EBITDAX1 ratio target of 1.0x by first-quarter 2023; Free Cash Flow for 2022-23 estimated at ~$900M at current commodity prices.
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VALU | Hot Stocks17:01 EDT Value Line announces renewal of buyback program - Value Line "reported that on May 31, 2022, the board approved a renewal of the share repurchase program, effective immediately, allowing the repurchase of shares from time to time, up to an additional amount of $3,000,000. The new repurchase program, which replaces the March 2022 program, has no set price limit and no expiration date and makes available a total of approximately $3.04M."
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OSTK | Hot Stocks16:58 EDT Overstock.com up 2.5% at $31.77 after Simcoe disclosed 5.7% stake
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OSTK | Hot Stocks16:58 EDT Simcoe Capital discloses 5.7% activist stake in Overstock.com - Simcoe Capital disclosed a 5.7% stake in Overstock.com, which represents over 2.44M shares. The filing allows for activism.
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APPS | Hot Stocks16:56 EDT Digital Turbine delays 10-K filing - In a regulatory filing, the company said, "As previously announced, Digital Turbine consummated two significant strategic acquisitions during the fiscal year ended March 31, 2022. In addition, the company filed amended Form 10-Q/As for the quarterly and year-to-date periods ended June 30, 2021, September 30, 2021, and December 31, 2021, on May 27, 2022 related to the previously-disclosed restatement of financial statements during such periods. The inclusion of the acquisitions in the audit of the company's Annual Report on Form 10-K for the fiscal year-ended March 31, 2022 and the filing of the Form 10-Q/As have utilized significant internal resources, which has impacted the company's ability to provide all the necessary information to their auditors for them to complete the audit. As a result, the Form 10-K cannot be filed within the required time period. The company expects to file the Form 10- K within the fifteen-calendar day grace period, as provided by Rule 12b-25 of the Securities Exchange Act of 1934. As disclosed in the company's Form 10-Q/As filed with the SEC on May 27, 2022, the company has identified a material weakness in its internal control over financial reporting related to the presentation of certain revenue net of license fees and revenue share expense and the classification of certain hosting costs. Although the company's management is still in the process of assessing the effectiveness of internal control over financial reporting as of March 31, 2022, the company expects to report such material weakness in the company's internal control over financial reporting in the Form 10-K, and to therefore conclude that the company did not maintain effective internal control over financial reporting and disclosure controls and procedures as of March 31, 2022."
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APPS | Hot Stocks16:53 EDT Digital Turbine delays 10-K filing - In a regulatory filing, the company said, "As previously announced, Digital Turbine consummated two significant strategic acquisitions during the fiscal year ended March 31, 2022. In addition, the company filed amended Form 10-Q/As for the quarterly and year-to-date periods ended June 30, 2021, September 30, 2021, and December 31, 2021, on May 27, 2022 related to the previously-disclosed restatement of financial statements during such periods. The inclusion of the acquisitions in the audit of the company's Annual Report on Form 10-K for the fiscal year-ended March 31, 2022 and the filing of the Form 10-Q/As have utilized significant internal resources, which has impacted the company's ability to provide all the necessary information to their auditors for them to complete the audit. As a result, the Form 10-K cannot be filed within the required time period. The company expects to file the Form 10- K within the fifteen-calendar day grace period, as provided by Rule 12b-25 of the Securities Exchange Act of 1934."
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IDN | Hot Stocks16:52 EDT Intellicheck receives not in compliace letter from Nasdaq - Intellicheck announced that it received on May 24, a written notice from the Listing Qualifications Department of the Nasdaq Stock Market notifying the Company that it was not in compliance with the requirements of Nasdaq Listing Rule 5250 as a result of not having timely filed its Quarterly Report on Form 10-Q for the quarterly period ended March 31. The Notice has no immediate effect on the listing or trading of Intellicheck's common stock on the Nasdaq CStock Market. Under the Nasdaq Rules, the Company has 60 calendar days to file the Q1 Form 10-Q with the SEC or submit a plan to regain compliance with Rule 5250. Intellicheck currently anticipates that it will file the Q1 Form 10-Q within the next 10 days, and at such time will regain compliance with Nasdaq Listing Rule 5250.
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SQZ | Hot Stocks16:46 EDT SQZ Biotechnologies appoints Marshelle Smith Warren as Chief Medical Officer - SQZ Biotechnologies announced that it has appointed Marshelle Smith Warren, as Chief Medical Officer. Warren will report to the CEO and lead the company's clinical development, clinical operations, translational medicine, and regulatory affairs functions. Warren brings over 25 years of clinical development industry experience to the company, including a particular focus on viral malignancies and T cell-directing therapeutics. Previously, she was Chief Medical Officer and Senior Vice President of R&D at Viracta Therapeutics, where she led the development of investigational therapeutics for the treatment of Epstein-Barr virus associated lymphoid malignancies. Her prior experience also includes clinical development positions at Allovir, Atara Biotherapeutics, Ionis, Gilead Sciences, Amgen, and AstraZeneca Pharmaceuticals. Warren has also recently served as a senior advisor on Phase 2 and Phase 3 clinical research programs for investigational T cell therapies targeting cancer, autoimmunity, and viral infections.
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UNVR CBT | Hot Stocks16:38 EDT Univar appointed distributor of Cabot's specialty carbon black product in Brazil - Univar Solutions (UNVR) "announced it has been appointed as distributor of Cabot Corporation's (CBT) specialty carbon black products for the plastics and batteries markets in Brazil. The agreement builds on the companies' existing relationship and will provide customers with innovative materials and solutions that help improve sustainability and product performance."
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PTVE VAL | Hot Stocks16:33 EDT Pactiv Evergreen appoints Jonathan Baksht as CFO - Pactiv Evergreen (PTVE) announced that Jonathan "Jon" Baksht joined the company as CFO, effective May 27. Baksht serves as a member of Pactiv Evergreen's Executive Leadership Team reporting to its President and CEO, Michael King. Baksht joins Pactiv Evergreen after having most recently served as Executive Vice President and CFO of Valaris (VAL), the world's largest global offshore drilling contractor. Baksht serves as a key strategic partner to King and his executive leadership team, while overseeing every aspect of the Company's finance function, including accounting, financial planning and analysis, investor relations, tax, treasury and internal audit. He is also responsible for the Company's Information Technology function. Prior to assuming the role of CFO of Valaris in 2015, Baksht served as Vice President - Finance, where he led all FP&A activities and served as Valaris' Principal Accounting Officer.
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FLO | Hot Stocks16:32 EDT Flowers Foods COO Bradley Alexander to retire, Heeth Varnedoe to succeed - Flowers Foods announced that effective December 31, 2022, Bradley Alexander, COO, will retire from the company after 41 years of service. Consistent with the company's management succession plan, on January 1, 2023, Heeth Varnedoe, the company's current chief transformation officer, will succeed Alexander as COO.
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BKH | Hot Stocks16:31 EDT Black Hills announces Colorado Electric plan to achieve 90% cut in CO2 emissions - Black Hills "announced plans for its Colorado Electric utility subsidiary, doing business as Black Hills Energy, to achieve a 90% reduction in greenhouse gas emissions by 2030 based on 2005 levels. This milestone, and the journey to 2030, is outlined in the company's Clean Energy Plan, "2030 Ready Plan," submitted to the Colorado Public Utilities Commission on May 27, 2022. The plan establishes a roadmap and preferred resource portfolio for Black Hills Energy to cost-effectively achieve the state of Colorado's "80 x 30" requirement calling upon electric utilities to reduce GHG emissions by a minimum of 80% by 2030."
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CRM | Hot Stocks16:21 EDT Salesforce reports Q1 cRPO up 21% y/y at $21.5B
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STRL | Hot Stocks16:19 EDT Sterling Construction to change its name to Sterling Infrastructure, Inc. - Sterling Construction "announced that the company will change its name to "Sterling Infrastructure, Inc.", which the company expects to take effect on June 1, 2022. The new name, logo and branding elements were introduced to better reflect the company's position as an industry leader specializing in E-Infrastructure, Building and Transportation Solutions. Once primarily a highway and bridge construction company, Sterling is now an infrastructure solutions provider with a portfolio of diversified, value-added services and an expanded footprint in high-growth end markets."
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SIX | Hot Stocks16:18 EDT Six Flags names Gary Mick as new CFO - Six Flags "announced that it has appointed Gary Mick as Chief Financial Officer effective June 1, 2022. In his new role, Mr. Mick will have responsibility for the company's financial strategy, budgeting, accounting, financial reporting, audit, tax and capital planning functions. Steve Purtell, who has filled the CFO position on an interim basis since March 2022, will continue to serve as Senior Vice President, Corporate Communications, Investor Relations and Treasurer, reporting to Selim Bassoul, President and CEO."
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CASS | Hot Stocks16:18 EDT Cass Information Systems to acquire TouchPoint - Cass Information Systems "has entered into an agreement to acquire the assets of mobile church management software developer TouchPoint, a division of The Pursuant Group, Inc., based in Dallas, Texas. TouchPoint's solutions help faith-based and non-profit organizations engage members and efficiently manage activities."
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VICI | Hot Stocks16:17 EDT VICI Properties names Kellan Florio as Chief Investment Officer - VICI Properties announced the appointment of Kellan Florio, Senior Vice President, Chief Investment Officer and Moira McCloskey, Vice President, Capital Markets. Mr. Florio will be responsible for leading VICI's expansion across experiential real estate investments with world class operators, reporting to John Payne, President and Chief Operating Officer. Ms. McCloskey will be responsible for leading VICI's capital markets initiatives and continuing to expand VICI's relationships and access to capital across domestic and international debt and equity markets, reporting to David Kieske, Executive Vice President, Chief Financial Officer.
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GLBL | Hot Stocks16:16 EDT Cartesian Growth gets pre-closing approvals for combination with Tiedemann - Cartesian Growth "announced that it has received the required pre-closing approvals from the applicable regulatory and governmental authorities in certain jurisdictions where Tiedemann Group and Alvarium Investments Limited operate with respect to the previously announced business combination among Cartesian, Tiedemann and Alvarium. Upon closing of the transaction, the combined company will operate as Alvarium Tiedemann Holdings and will be listed on NASDAQ under the ticker symbol "GLBL," consistent with Cartesian's current listing. The successful closing of the transaction, expected in the second half of 2022, is subject to the satisfaction of customary closing conditions, including the registration statement being declared effective by the Securities and Exchange Commission and shareholder approval."
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HGBL | Hot Stocks16:14 EDT Heritage Global appoints Brian Cobb CFO - Heritage Global announced that VP of Finance Brian Cobb has been appointed CFO, effective immediately. As CFO, Cobb will be responsible for all financial activities including accounting, financial reporting, planning and analysis, investor relations, mergers and acquisitions, taxes, and treasury to support the company's overall growth objectives. Cobb joined the Heritage team in 2017 as the Director of Financial Reporting, with extended responsibilities to manage corporate and divisional accounting functions and personnel.
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TNXP | Hot Stocks16:14 EDT Tonix Pharmaceuticals board approves $12.5M share repurchase program - Tonix Pharmaceuticals Holding announced that its Board of Directors has approved a share repurchase program pursuant to which the Company may repurchase up to $12.5M in value of its outstanding common stock, par value, $0.001 per share, from time to time on the open market and in privately negotiated transactions subject to market conditions, share price and other factors . The Company intends to fund the Share Repurchase Program with available cash.
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FB META | Hot Stocks16:13 EDT Meta Platforms to change ticker symbol to 'META' on June 9 - Meta Platforms announced that its Class A common stock will begin trading on NASDAQ under the ticker symbol 'META' prior to market open on June 9. This will replace the company's current ticker symbol 'FB', which has been used since its initial public offering in 2012. The new ticker symbol aligns with the company's rebranding from Facebook to Meta, announced on October 28, 2021.
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SB | Hot Stocks16:10 EDT Safe Bulkers to acquire two Chinese dry-bulk vessels - Safe Bulkers announced that it has entered into an agreement for the acquisition of two Chinese dry-bulk, 82,500 dwt, Kamsarmax class vessels with scheduled delivery dates within August 2024 and January 2025. The newbuild vessels are designed to meet the requirements of Energy Efficiency Design Index related to Green House Gas, GHG emissions, 'EEDI, Phase 3' to comply with the NOx emissions regulation, NOx-Tier III. Including this agreement and following the delivery of its first Phase 3 newbuild in May, the company has an outstanding orderbook of 10 newbuild vessels, with scheduled deliveries one in 2022, five in 2023, three in 2024 and one in 2025, of which three are Post-panamax class and seven are Kamsarmax class vessels.
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ICFI... | Hot Stocks16:09 EDT ICF International partners with Google Cloud - ICF (ICFI) is partnering with Google Cloud (GOOG, GOOGL) to expand its cloud and analytics services to public sector clients. ICF's partnership with Google Cloud illustrates ICF's success in accelerating digital transformation for federal agencies on Google Cloud's platform, which includes supporting federal health clients such as the National Cancer Institute and many others. The partnership further expands the company's digital and partnership ecosystem in support of its multi-cloud strategy. Combining ICF's deep domain and technology consulting expertise with new Google Cloud capabilities enhances ICF's capabilities to rapidly deploy digital solutions that advance our customers' missions and increase operational efficiency.
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FHN TD | Hot Stocks16:07 EDT First Horizon shareholders approve transaction with Toronto-Dominion - First Horizon (FHN) announced that it has received shareholder approval for The Toronto-Dominion Bank (TD) to acquire First Horizon. The transaction is expected to close in the first quarter of TD's 2023 fiscal year subject to U.S. and Canadian regulatory approvals and the completion of other necessary closing conditions.
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FB | Hot Stocks16:06 EDT Meta Platforms to change ticker symbol to 'META' on June 9 - Meta Platforms announced that its Class A common stock will begin trading on NASDAQ under the ticker symbol 'META' prior to market open on June 9. This will replace the company's current ticker symbol 'FB', which has been used since its initial public offering in 2012. The new ticker symbol aligns with the company's rebranding from Facebook to Meta, announced on October 28, 2021.
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ALGM | Hot Stocks16:04 EDT Allegro to acquire Heyday Integrated Circuits for $19M in cash - Allegro MicroSystems announced the entry into an agreement to acquire Heyday Integrated Circuits Heyday. Heyday is a privately-held company specializing in compact, fully-integrated isolated gate drivers that enable energy conversion in high-voltage gallium nitride GaN and silicon carbide SiC wide-bandgap WBG semiconductor designs. The Heyday acquisition will complement Allegro's existing solutions for energy efficiency, including its market-leading current sensor solutions. Additionally, it is expected to significantly expand Allegro's addressable market for electric vehicles xEV, solar inverters, datacenter and 5G power supplies, and broad-market industrial applications. "With high-powered GaN and SiC wide bandgap systems expected to grow significantly over the next decade, our customers are facing an exponential demand for simplified power management solutions," said Michael Doogue, Senior Vice President of Technology and Products at Allegro. "High-voltage isolated gate drivers are a fundamental enabling technology for the future of high-efficiency power system designs. Coupled with our market-leading integrated current sensors, Heyday's Power-Thru technology will allow our customers to build some of the smallest high-voltage and high efficiency power systems available. Allegro will pay approximately $19M in cash for the acquisition of Heyday, subject to customary purchase price adjustments. The acquisition is expected to close in the third quarter of calendar year 2022, subject to customary closing conditions and required regulatory approvals
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ARQQ | Hot Stocks16:00 EDT Arqit Quantum trading resumes
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ARQQ | Hot Stocks15:51 EDT Arqit Quantum trading halted, volatility trading pause
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RGF | Hot Stocks15:45 EDT Real Good Food Company Inc trading resumes
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RGF | Hot Stocks15:40 EDT Real Good Food Company Inc trading halted, volatility trading pause
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NFLX | Hot Stocks15:38 EDT Netflix says 'Stranger Things' had record English language premiere weekend - Netflix tweeted: "Stranger Things 4 has been running up that hill since Friday, becoming the biggest premiere weekend ever for an English language TV show on Netflix with 286.79 million hours viewed globally! It also skyrocketed to the 001 spot in 83 countries - another premiere weekend record!" Reference Link
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DIS | Hot Stocks15:35 EDT Disney says Obi Wan 'most-watched' Disney+ original series premiere to date - The official Twitter account of Disney+ tweeted: "Thank you to the best fans in the galaxy for making @ObiWanKenobi the most-watched #DisneyPlus Original series premiere globally to date, based on hours streamed in an opening weekend." Reference Link
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XELB | Hot Stocks15:20 EDT Xcel Brands trading resumes
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XELB | Hot Stocks15:03 EDT Xcel Brands sells controlling stake in Isaac Mizrahi to WHP Global for $68M - Xcel Brands and WHP Global announced that WHP will purchase a controlling 70% interest in fashion brand Isaac Mizrahi. The transaction, valued at $68M, includes $46.2M in cash proceeds to Xcel, which will retain a 30% minority interest in the Isaac Mizrahi brand. Under the terms of a services agreement with WHP Global, Xcel will continue to manage the QVC business with WHP Global and has entered into a new license agreement to design and distribute Isaac Mizrahi apparel in the U.S. and Canada. The Isaac Mizrahi brand has generated more than $1B in retail sales since its founding. Isaac Mizrahi will continue to serve as chief design officer
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XELB | Hot Stocks14:59 EDT Xcel Brands trading halted, news pending
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MDXG | Hot Stocks14:09 EDT Prescience Point accuses MiMedx board of 'failures,' 'massive value destruction' - Prescience Point Capital Management, which said it beneficially owns approximately 6.7% of the outstanding common stock of MiMedx Group, released a presentation detailing what it calls "the colossal failures and massive value destruction that have taken place" under the company's current Board of Directors and management. The presentation also "documents a misalignment of interests that has given an incentive to management, the Board and EW Healthcare Partners to keep MDXG's share price depressed," the firm stated in a press release.
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SPTN | Hot Stocks13:50 EDT SpartanNash says Glass Lewis recommends vote for company's director nominees - SpartanNash announced that independent proxy advisory firm Glass Lewis & Co has recommended that shareholders vote "for" all of SpartanNash director nominees on the white proxy card at the company's 2022 Annual Meeting of Shareholders scheduled for June 9. Commenting on the Glass Lewis report, SpartanNash issued the following statement: "We are pleased that Glass Lewis supports voting on the WHITE proxy card to elect all nine of the company's highly qualified director nominees and clearly recognizes that SpartanNash has the right Board and the right strategy to continue to deliver enhanced value for shareholders. Further, Glass Lewis recognizes that Macellum and Ancora have not offered a sufficiently compelling case to warrant supporting their nominees and that electing their nominees would deprive SpartanNash of skills and expertise that are essential to continuing the company's momentum."
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INTC | Hot Stocks13:40 EDT Intel debuts Rialto Bridge GPU, succeeding Ponte Vecchio architecture - Jeff McVeigh, VP, General manager of Intel's Super Compute Group said in part in a company blog : "This year, Intel committed to achieve net-zero greenhouse gas emissions in our global operations by 2040 and to develop more sustainable technology solutions. Keeping up with the insatiable demands for computing while creating a sustainable future is one of the biggest challenges for high performance computing, HPC. While daunting, it is achievable if we address every part of the HPC compute stack - silicon, software, and systems. We have an aggressive HPC roadmap planned through 2024 that will deliver a diverse portfolio of heterogeneous architectures. These architectures will allow us to improve performance by orders of magnitude while reducing power demands across both general-purpose and emerging workloads such as AI, encryption and analytics...The Intel Xeon processor code-named Sapphire Rapids with High Bandwidth Memory, HBM, is a great example of how we are leveraging advanced packaging technologies and silicon innovations to bring substantial performance, bandwidth and power-saving improvements for HPC...We are not stopping here... We are announcing our successor to this powerhouse data center GPU, code-named Rialto Bridge. By evolving the Ponte Vecchio architecture and combining enhanced tiles with next process node technology, Rialto Bridge will offer significantly increased density, performance and efficiency, while providing software consistency." Reference Link
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ZKIN | Hot Stocks13:18 EDT ZK International portfolio company announces partnership with Nicki Minaj - Shares of ZK International Group are up 26%, or 33c, to $1.60 after the company announced that Nicki Minaj has agreed to a sports betting multi-year, global partnership with MaximBet, a ZKIN portfolio company. ZKIN has invested $25M into MaximBet and currently owns 16% of the company, ZK International noted in its press release announcing the pact. MaximBet is currently live in the state of Colorado and is on track to launch in nine additional U.S. states and the Canadian province of Ontario, the company noted. "Nicki Minaj is one of the most iconic and influential entertainers in the world. The conversion of entertainment and sport is happening at warp speed, and we've built a brand that can appropriately stand at the center of that. Nicki's business experience and relationships open a wealth of opportunity for MaximBet and her involvement as an owner will allow us to work together on decisions in all parts of the business," said Daniel Graetzer, CEO, MaximBet.
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ORPH KMPH | Hot Stocks13:00 EDT Orphazyme completes sale of assets, business activities to KemPharm - Orphazyme A/S (ORPH) announced that it has completed the sale of substantially all of its assets and business activities for a cash consideration of $12.8M and assumption of liabilities estimated to equal approximately $5.2M to KemPharm (KMPH) following the adoption of the restructuring proposal. Following completion of the Sale of Assets to KemPharm, Orphazyme will no longer have any material ongoing operational business activities and KemPharm will retain all of Orphazyme's remaining Danish employees, to continue the early access programs with arimoclomol, and to continue to pursue the potential approval of arimoclomol as a treatment option for NPC.
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SPR | Hot Stocks12:01 EDT Spirit AeroSystems announces long-term strategic partnership with Sierra Space - Sierra Space and Spirit AeroSystems announced the formation of a long-term strategic partnership intended to "accelerate access to a vibrant commercial space economy of the future." The companies said: "Spirit Defense & Space will assist in the development and production of future affordable Shooting Star Transport Vehicles under a Letter of Intent signed between the two companies. The agreement also provides for the two companies to work together to develop innovative technologies and processes to accelerate Sierra Space's expanding Dream Chaser family of scalable spaceplanes to the market."
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PGRU | Hot Stocks12:00 EDT PropertyGuru falls -12.8% - PropertyGuru is down -12.8%, or -93c to $6.33.
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FRO | Hot Stocks12:00 EDT Frontline falls -14.0% - Frontline is down -14.0%, or -$1.60 to $9.83.
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GFI | Hot Stocks12:00 EDT Gold Fields falls -22.3% - Gold Fields is down -22.3%, or -$2.71 to $9.48.
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BKKT | Hot Stocks12:00 EDT Bakkt rises 14.5% - Bakkt is up 14.5%, or 39c to $3.04.
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YMM | Hot Stocks12:00 EDT Full Truck Alliance rises 14.7% - Full Truck Alliance is up 14.7%, or 87c to $6.81.
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CTT | Hot Stocks12:00 EDT CatchMark Timber rises 42.2% - CatchMark Timber is up 42.2%, or $3.50 to $11.80.
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CP KSU | Hot Stocks11:31 EDT Canadian Pacific announces multiyear agreement with CMA CGM - Canadian Pacific (CP) announced a new multi-year agreement with CMA CGM Group. CP will become CMA CGM's primary rail provider in Canada, servicing the ports of Vancouver, Montreal and Saint John, N.B. "CP is proud to provide CMA CGM with safe and reliable service that includes the shortest route miles to key markets," said John Brooks, CP Executive Vice-President and Chief Marketing Officer. This agreement also recognizes the future growth opportunities connected to CP's proposed combination with the Kansas City Southern (KSU), which remains subject to approval by the Surface Transportation Board.
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JBLU... | Hot Stocks10:55 EDT ISS recommends Spirit shareholders 'vote no' on Frontier transaction - JetBlue (JBLU) announced that Institutional Shareholder Services has issued a report recommending that Spirit (SAVE) shareholders vote AGAINST the "inferior, high-risk, and low-value" Frontier (ULCC) transaction at Spirit's upcoming special meeting. "We are pleased that ISS recognized that our proposal offers Spirit shareholders superior value and has a clear path to completion," said Robin Hayes, CEO, JetBlue. "The ISS report highlights the flawed process that the conflicted Spirit Board followed, which only underscores the need for Spirit's Board to now come to the table and negotiate - this time in good faith - with JetBlue. Spirit shareholders can send that strong message to their Board by voting against the Frontier transaction and against adjournment. The ISS report highlighted: "The offer from JetBlue is superior from a financial standpoint, with a cash consideration at a meaningfully higher premium than the mostly stock deal from Frontier ... On balance, a potential agreement with JetBlue would appear to offer shareholders superior optionality, allowing those concerned with the turbulence ahead to exit at a significant premium, while allowing those with a more optimistic outlook to reinvest the premium consideration."
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STLA TM | Hot Stocks10:43 EDT Stellantis, Toyota expand partnership with new large-size commercial van - Stellantis (STLA) and Toyota Motor Europe (TM) announced the expansion of their existing partnership with an agreement for a new large-size commercial van, including a battery electric version. Stellantis will supply TME with the new large-size commercial van for sale in Europe under the Toyota brand. The new vehicle will be produced at Stellantis' plants in Gliwice, Poland and Atessa, Italy. Planned for mid-2024, the new large-size commercial van marks TME's first entry into the large-size commercial vehicle segment. "Operational excellence is by definition recognized in this expanded deal," said Carlos Tavares, Stellantis CEO. "With this third successful engagement, Stellantis is further demonstrating its expertise in the commercial vehicle segment and in developing battery electric technology built to support a full range of needs. This agreement strengthens our leadership in the EU30 for LCVs and low emission vehicles and moves us a step closer to realizing our Dare Forward 2030 goal of becoming the undisputed global light commercial vehicle leader, in terms of technology, manufacturing, market share and profitability."
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BLNK | Hot Stocks10:33 EDT Blink Charging unit to deploy 600 charging points in U.K., Ireland - EB Charging, a Blink Charging wholly owned company, announced an agreement with Q-Park, a parking infrastructure owner and operator in Europe, to deploy nearly 600 charging points across 80 sites in the United Kingdom and Ireland. The agreement, totaling over GBP 3M, or more than $3.7Mn, will initiate EB Charging's rollout of over 600 charging points across Q-Park's portfolio of parking facilities in the UK and Ireland. Installations are due to commence in July 2022 and will include the modernization of the existing charging infrastructure with EB Charging's hardware. As part of this agreement, EB Charging will be responsible for the installation of the EV charging hardware and for the management of the charging provision, including a 24/7 customer support service to Q-Park EV customers.
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PGRU | Hot Stocks10:00 EDT PropertyGuru falls -11.7% - PropertyGuru is down -11.7%, or -85c to $6.41.
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FRO | Hot Stocks10:00 EDT Frontline falls -13.2% - Frontline is down -13.2%, or -$1.51 to $9.92.
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GFI | Hot Stocks10:00 EDT Gold Fields falls -19.6% - Gold Fields is down -19.6%, or -$2.39 to $9.81.
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NINE | Hot Stocks10:00 EDT Nine Energy Service rises 12.8% - Nine Energy Service is up 12.8%, or 41c to $3.65.
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EC | Hot Stocks10:00 EDT Ecopetrol rises 13.6% - Ecopetrol is up 13.6%, or $2.08 to $17.39.
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CTT | Hot Stocks10:00 EDT CatchMark Timber rises 41.0% - CatchMark Timber is up 41.0%, or $3.40 to $11.70.
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IMTE | Hot Stocks09:57 EDT Intergrated Media Technology Ltd trading resumes
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IMTE | Hot Stocks09:52 EDT Intergrated Media Technology Ltd trading halted, volatility trading pause
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PGRU | Hot Stocks09:47 EDT PropertyGuru falls -11.6% - PropertyGuru is down -11.6%, or -84c to $6.42.
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FRO | Hot Stocks09:47 EDT Frontline falls -12.8% - Frontline is down -12.8%, or -$1.47 to $9.96.
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GFI | Hot Stocks09:47 EDT Gold Fields falls -15.2% - Gold Fields is down -15.2%, or -$1.85 to $10.35.
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EC | Hot Stocks09:47 EDT Ecopetrol rises 11.8% - Ecopetrol is up 11.8%, or $1.80 to $17.11.
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BORR | Hot Stocks09:47 EDT Borr Drilling rises 12.0% - Borr Drilling is up 12.0%, or 60c to $5.63.
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CTT | Hot Stocks09:47 EDT CatchMark Timber rises 42.0% - CatchMark Timber is up 42.0%, or $3.49 to $11.79.
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SGML | Hot Stocks09:46 EDT SGML Stock trading resumes
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BMRN | Hot Stocks09:44 EDT BioMarin delays hemophilia FDA submission to end of September - BioMarin said it plans to include the previously reported results from the two-year follow-up safety and efficacy data from the Phase 3 GENEr8-1 study in a Biologics Licensing Application resubmission for valoctocogene roxaparvovec, an investigational gene therapy treatment for adults with severe hemophilia A, to the Food and Drug Administration. Based on recent feedback received from the FDA related to BioMarin's plans for the upcoming BLA, the Agency has requested additional information and analyses of data to be included in the BLA prior to submission, the company noted in a press release. The FDA has not requested additional pre-clinical or clinical studies. "While at present, no requests have been made concerning evaluation of efficacy and safety three years after dosing from the GENEr8-1 study, BioMarin is aware that such data will become available during the anticipated BLA review. Based on these new information requests, the BLA resubmission is now expected by the end of September," the company said. Shares of BioMarin are down 3% to $78.89 in early trading.
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ASXC | Hot Stocks09:38 EDT FDA posts 510(k) Premarket Notification for Asensus' Senhance Surgical System - The FDA posted a 510(k) Premarket Notification for Asensus Surgical's Senhance Surgical System, dated May 27, that showed that the system was judged to be "Substantially Equivalent." Reference Link
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SGML | Hot Stocks09:36 EDT SGML Stock trading halted, volatility trading pause
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JCSE | Hot Stocks09:35 EDT JE Cleantech Holdings Ltd trading resumes
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JCSE | Hot Stocks09:30 EDT JE Cleantech Holdings Ltd trading halted, volatility trading pause
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PODD DXCM | Hot Stocks09:29 EDT Insulet down 11% after DexCom says 'not in active discussions' about merger - Bloomberg had reported last week that CGM maker DexCom (DXCM) was in talks to buy insulin pump maker Insulet (PODD), but the former announced this morning in "response to recent media and market speculation" that "Dexcom is not in active discussions regarding a merger transaction at this time."
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TYL | Hot Stocks09:19 EDT Tyler Technologies acquires Quatred, terms undisclosed - Tyler Technologies announced it has acquired Quatred, a systems integrator and solution provider that assists clients with implementing advanced touchless technologies, including barcoding. Quatred has been a Tyler partner since 2018, when Tyler began integrating with Quick, a wireless, service-oriented architecture foundation, providing rapid deployment. These mobile solutions interact in real-time with Tyler's Enterprise ERP solution, powered by Munis, to track assets and inventory transactions. Through this acquisition, Tyler will integrate Quatred's barcoding technology into additional Tyler solutions. Founded in 2005 by Marc Doyon, Quatred is based in Center Barnstead, New Hampshire. The company's employees will join Tyler as full-time employees.
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BIOR | Hot Stocks09:15 EDT Biora Therapeutics shares presentation on tofacitinib at DDW 2022 - Biora Therapeutics shared a presentation delivered during Digestive Disease Week, DDW, May 21-24, 2022 in San Diego. Key opinion leader Dr. Severine Vermiere gave a presentation titled "Tofacitinib tissue exposure correlates with endoscopic outcome," which Dr. Vermiere co-authored with lead author Dr. Bram Verstockt and others. In the presentation, Dr. Vermiere presented patient data confirming a significant relationship between drug levels in tissue and endoscopic improvement in patients with moderate to severe ulcerative colitis who were treated with tofacitinib. "This study supports the hypothesis that a tissue concentration of tofacitinib at or exceeding IC90 is directly correlated to significant improvement in patient outcomes," Adi Mohanty, Chief Executive Officer of Biora Therapeutics. "Our targeted delivery platform is uniquely positioned to be able to safely deliver the desired amount of drug to the diseased tissue in UC. Our phase 1 clinical study planned to begin later this year, along with the various safety data, will provide us with valuable information on concentrations of tofacitinib in tissue as well as the level of systemic exposure," continued Mohanty. "We recently also shared data about the potential importance of combination therapy for the UC patient community. Reducing systemic uptake with PGN-600 could enable combination therapy to target multiple inflammatory pathways. We believe our approach could allow for multiple ways to improve therapeutic outcomes for the large number of UC patients who are still significantly lacking in options."
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BOWL | Hot Stocks09:14 EDT Bowlero acquires bowling centers in Florida, Colorado - Bowlero Corp. announced that it has acquired two additional bowling centers - Manatee Lanes in metro Tampa, FL and Fat Cats in Westminster, CO. Bowlero Promenade will mark the company's 13th location in Colorado, joining seven Bowlero centers and five AMF centers in the state.
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YMAB | Hot Stocks09:14 EDT Y-mAbs Therapeutics announces FDA acceptance of BLA for OMBLASTYS - Y-mAbs Therapeutics announced that the Biologics License Application, BLA, for OMBLASTYS for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma has been accepted for priority review by the U.S. Food and Drug Administration, FDA. The FDA set an action date of November 30, 2022, under the Prescription Drug User Fee Act, PDUFA. The Agency also indicated in the BLA filing communication letter that it is planning to hold an advisory committee meeting in October 2022 to discuss the application. "We believe that the FDA's acceptance of our OMBLASTYS BLA for priority review is a significant achievement for Y-mAbs and a crucial step forward as we anticipate that OMBLASTYS, if approved by the FDA, can address a significant unmet medical need for children with CNS/leptomeningeal metastasis from high-risk neuroblastoma, where no standard therapy currently exists, potentially adding a second rare disease product to our commercial portfolio and without any significant further investment in our existing commercial infrastructure. Further, OMBLASTYS has a Rare Pediatric Disease Designation which, if approved, will provide Y-mAbs with a Priority Review Voucher, our second PRV, which would further strengthen our financial position as we would seek to monetize the OMBLASTYS PRV," stated Thomas Gad, Founder, President and Interim CEO. "We look forward to working with the Agency to bring OMBLASTYS to the appropriate patients. We are excited to move forward and plan for a seamless commercial launch of OMBLASTYS, if approved by the FDA."
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GTLS | Hot Stocks09:12 EDT Chart Industries provides ESG update - Chart Industries provides an update to their environmental, social and governance, ESG, and sustainability progress. Effective as of its Annual Shareholder Meeting, ASM, on May 13, 2022, Singleton McAllister is the company's independent Chairwoman of our Board of Directors. Also effective as of our ASM, the board is comprised of seven directors; six directors are independent and four are female. Received our American Society of Mechanical Engineers XII certificate at our Theodore, Alabama facility effective May 20, 2022. Six additional Engineering Key Experts. Seven new Emerging Leaders. Two newly dedicated Emerging Leaders to our Lean/Continuous Improvement Center of Excellence. Implemented a dedicated team to energy management.
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ISIG | Hot Stocks09:11 EDT David Lazar announces 5.1% ownership interest in Insignia Systems - David E. Lazar, a private investor specializing in reverse merger and other event-driven opportunities, filed a Schedule 13D announcing his acquisition of approximately 5.1% of the common stock outstanding of Insignia Systems. Lazar issued the following statement: "I invested in ISIG due to the Company's stated intention to explore strategic options to maximize shareholder value, including, but not limited to, a potential acquisition, merger, business combination or other strategic transaction and its retention of a strategic financial advisor to assist the Company in this review process. I believe significant value can be unlocked at the Company and will be monitoring its developments with interest."
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CAT | Hot Stocks09:10 EDT Caterpillar announces project for hydrogen-fueled CHP system - Caterpillar announced a three-year project with Minnesota-based District Energy St. Paul to demonstrate a hydrogen-fueled combined heat and power, or CHP, system. The project is supported and partially funded by the U.S. Department of Energy and backed by the National Renewable Energy Laboratory. CHP systems from Caterpillar provide both electricity and heat simultaneously, increasing overall efficiency and reducing exhaust emissions. To assess the potential of a hydrogen-fueled CHP system under real-world operating conditions, power and heat from the demonstration project will integrate into District Energy St. Paul's electrical and thermal infrastructure. District Energy St. Paul distributes chilled water and hot water to heat and cool buildings and single-family homes in downtown St. Paul, Minnesota, and adjacent areas.
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GTLS | Hot Stocks09:10 EDT Chart Industries acquires Fronti Fabrications for $20M - Chart Industries completed the acquisition of Fronti Fabrications for $20M. Fronti is a specialist in engineering, machining and welding for the cryogenic and gas industries, and also supplies new build pressure vessels and performs repairs with certification to American Society of Mechanical Engineers, ASME, code. With over 20 years of experience in liquefaction, heat exchangers and cold boxes, Fronti adds a known team to expand Chart's cold box manufacturing capacity and capability, including work currently underway on Chart hydrogen and helium liquefiers. "The acquisition of Fronti brings another cryogenic industry partner into the Chart portfolio, expands our cold box manufacturing capability and capacity, and creates the foundation for our mid-Atlantic flexible manufacturing location," stated Jill Evanko, Chart's CEO and President. "We are also very excited to have Joe Fronti and the entire Fronti team continue with the business and work even closer with our existing teams on the heart and soul of LNG, hydrogen and helium liquefaction equipment."
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SILK | Hot Stocks09:10 EDT Silk Road Medical secures up to $250M in debt financing - Silk Road Medical announced that it has entered into a new five-year loan arrangement with Oxford Finance LLC comprising up to a $200M term loan and up to a $50M revolving line of credit. The transaction brings the company's total cash, cash equivalents, and access to liquidity to approximately $340M. "We are tremendously pleased to bolster our capital position through this financing, substantially enhancing our runway to invest for growth," said Lucas Buchanan, CFO and COO of Silk Road Medical. "This agreement provides additional financial flexibility at very favorable cost and terms in today's environment, including a capped interest rate through maturity. We look forward to leveraging this facility to strengthen our organization as we continue driving TCAR adoption and advancing the less invasive standard of care in stroke prevention."
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JAN | Hot Stocks09:08 EDT JanOne to sell GeoTraq to SPYR Technologies - SPYR Technologies announced its entry into a material definitive agreement to acquire GeoTraq, Inc. from NASDAQ traded JanOne Inc. GeoTraq develops and manufactures entirely self-contained and ultra-small Mobile IoT modules for asset tracking, location-based services, and sensor modules for remote monitoring. GeoTraq's initial product offerings are in the later stages of development and testing and will be available for deployment in Q1 of 2023.
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BEN BK | Hot Stocks09:08 EDT Franklin Templeton to acquire Alcentra from BNY Mellon in accretive transaction - Franklin Resources (BEN) a global investment management organization operating as Franklin Templeton, and The Bank of New York Mellon (BK) announced that Franklin Templeton has entered into a definitive agreement to acquire BNY Alcentra Group Holdings from BNY Mellon. One of the largest European credit and private debt managers, Alcentra has $38B in assets under management with global expertise in senior secured loans, high yield bonds, private credit, structured credit, special situations and multi-strategy credit strategies. Through this acquisition, Franklin Templeton's U.S. alternative credit specialist investment manager, Benefit Street Partners , will expand its alternative credit capabilities and presence in Europe, doubling its assets under management to $77B globally. The transaction will also continue to strengthen the breadth and scale of Franklin Templeton's alternative asset strategies and brings firmwide alternative assets under management to $257B after the transaction closes. The transaction is expected to be completed early in the first calendar quarter of 2023, subject to customary closing conditions, including certain regulatory approvals. The acquisition will be funded from Franklin Templeton's existing balance sheet resources and is expected to be immediately accretive to adjusted earnings per share. Franklin Templeton will pay $350 million in cash at close and up to a further $350 million in contingent consideration dependent on the achievement of certain performance thresholds over the next four years. In addition, Franklin Templeton has committed to purchase all seed capital investments from BNY Mellon related to Alcentra which, as of March 31 , were valued at approximately $305M. The seed capital investments will be valued at the time of close to determine the final seed capital purchase amount. An investor presentation on the transaction is available via investors.franklintempleton.com. Upon closing, BNY Mellon Investment Management will continue to offer Alcentra's capabilities in BNY Mellon's sub-advised funds and in select regions via its global distribution platform, and BNY Mellon will provide Alcentra with ongoing asset servicing support. At close, BNY Mellon expects the transaction to increase BNY Mellon's Common Equity Tier 1 capital by approximately $0.5B
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BEN BK | Hot Stocks09:08 EDT Franklin Templeton to acquire Alcentra from BNY Mellon in accretive transaction - Franklin Resources (BEN) a global investment management organization operating as Franklin Templeton, and The Bank of New York Mellon (BK) announced that Franklin Templeton has entered into a definitive agreement to acquire BNY Alcentra Group Holdings from BNY Mellon. One of the largest European credit and private debt managers, Alcentra has $38B in assets under management with global expertise in senior secured loans, high yield bonds, private credit, structured credit, special situations and multi-strategy credit strategies. Through this acquisition, Franklin Templeton's U.S. alternative credit specialist investment manager, Benefit Street Partners , will expand its alternative credit capabilities and presence in Europe, doubling its assets under management to $77B globally. The transaction will also continue to strengthen the breadth and scale of Franklin Templeton's alternative asset strategies and brings firmwide alternative assets under management to $257B after the transaction closes. The transaction is expected to be completed early in the first calendar quarter of 2023, subject to customary closing conditions, including certain regulatory approvals. The acquisition will be funded from Franklin Templeton's existing balance sheet resources and is expected to be immediately accretive to adjusted earnings per share. Franklin Templeton will pay $350 million in cash at close and up to a further $350 million in contingent consideration dependent on the achievement of certain performance thresholds over the next four years. In addition, Franklin Templeton has committed to purchase all seed capital investments from BNY Mellon related to Alcentra which, as of March 31 , were valued at approximately $305M. The seed capital investments will be valued at the time of close to determine the final seed capital purchase amount. An investor presentation on the transaction is available via investors.franklintempleton.com. Upon closing, BNY Mellon Investment Management will continue to offer Alcentra's capabilities in BNY Mellon's sub-advised funds and in select regions via its global distribution platform, and BNY Mellon will provide Alcentra with ongoing asset servicing support. At close, BNY Mellon expects the transaction to increase BNY Mellon's Common Equity Tier 1 capital by approximately $0.5B
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BKI | Hot Stocks09:06 EDT Black Knight announces strategic alliance with Percy - Black Knight announced a strategic alliance with Nashville-based Percy, formerly known as Buyside, a data analytics and marketing company that collects and analyzes real estate consumer behavior using machine learning and artificial intelligence. The alliance will allow Black Knight to offer clients a new, advanced consumer engagement solution fueled by billions of behavioral datapoints that helps real estate professionals and lenders cultivate deeper customer relationships. Using proprietary machine learning to monitor homeowner behavior "signals" through custom landing pages with engaging content, Percy helps identify the precise timing that a homeowner is likely to transact.
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V | Hot Stocks09:05 EDT Visa partners with Fundbox on payment capabilities - Visa announced that it is partnering with Fundbox, an embedded working capital platform for small businesses, to strengthen Fundbox's platform with the power of digital payments. The first step in this collaboration is the launch of the Fundbox Flex Visa Debit Card, issued by Pathward, N.A. In addition to the Fundbox Flex Card, Fundbox and Visa will work together in the coming months in an effort to introduce a series of new payment products, including a Buy Now, Pay Later, or BNPL, solution for small businesses looking for flexible payment options when making purchases, and a push-to-card transfer option for instant fund disbursement through Visa Direct1, Visa's real-time money movement network.
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SYK | Hot Stocks09:04 EDT Stryker receives FDA clearance for Q guidance system for spine applications - Stryker announced that its Q Guidance System received 510k clearance from the U.S. Food and Drug Administration. The System, when used with the Spine Guidance Software, is an advanced planning and intraoperative guidance system designed to enable open or percutaneous computer-assisted surgery. The Spine Guidance Software is the first spine navigation software to receive clearance from the FDA for use with pediatric patients aged 13 and older. Stryker's Q Guidance System aims to deliver surgical spine planning and navigation capability through multiple tracking options, sophisticated software algorithms and smart instrumentation. It features a high-performance navigation camera built on the company's 20 years of experience developing guidance technologies. Q Guidance features completely redesigned software applications, semi-automatic and automatic segmentation features, gesture recognition, and broad compatibility with various types of image sets. When used with Airo TruCT mobile CT scanner, this ecosystem delivers automatic image registration and pairs high performance tracking capabilities with cutting edge intraoperative image quality and scan volume. "The versatility of the Q Guidance System will help to streamline our technologies across multiple specialties such as cranial, spine, ENT and orthopaedics," said Robbie Robinson, President of the Spine division. "The System is designed for future compatibility with a fully integrated ecosystem, driving more value for our customers. With a robust product pipeline in place, we are positioned to provide a well-rounded, end-to-end platform for our surgeon customers, with the ability to incorporate robotics and intelligent handheld instruments in the future."
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SSTK | Hot Stocks09:04 EDT Shutterstock acquires Splash News, no terms disclosed - Shutterstock announced the acquisition of Splash News, one of the world's "leading" entertainment news networks for newsrooms and media companies. A leading source for image and video content across celebrity, red carpet and live events for over three decades, Splash News is an industry leader with customers including E! News, People, Daily Mail, TMZ, Dow Jones, Reach and News UK. Splash's comprehensive collection includes an archive of over 27M images, and a contributor network of more than 4,000 photographers. Terms of the transaction were not disclosed.
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AMGN | Hot Stocks09:02 EDT Amgen reports data from Phase 2 OCEAN-DOSE clinical study - Amgen announced positive topline data from the Phase 2 OCEAN-DOSE clinical study, evaluating olpasiran in 281 adult patients with Lipoprotein, or Lp, levels over 150 nmol/L and evidence of atherosclerotic cardiovascular disease, or ASCVD. Olpasiran is a small interfering RNA designed to lower the body's production of apolipoprotein, a key component of Lp that has been associated with an increased risk of cardiovascular events. In the double-blind placebo-controlled treatment period, olpasiran was administered up to 225 mg subcutaneously every 12 weeks to patients with a median baseline Lp of approximately 260 nmol/L. These data demonstrated a significant reduction from baseline in Lp of up to or greater than 90% at week 36 and week 48 for the majority of doses. No new safety concerns were identified during this treatment period.Data from the Phase 2 study will be presented at a future medical congress and submitted for publication.
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CYTO | Hot Stocks09:00 EDT Altamira announces Bentrio approved by Ministry of Health of Indonesia - Altamira Therapeutics announced that Bentrio has been approved by the Ministry of Health of Indonesia and is, therefore, cleared for commercialization in that country.
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HOOD | Hot Stocks08:48 EDT Robinhood to settle customer lawsuit over 2020 outage, Reuters reports - Robinhood Markets has agreed to settle a customer lawsuit over a March 2020 outage of its trading app, Reuters' Jody Godoy reports. A court filing shows that the company is working out final details of the settlement, but did not say how much Robinhood would pay to resolve the lawsuit. Reference Link
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SNY | Hot Stocks08:44 EDT Sanofi: FDA places Actual Use Trial of Cialis Rx to OTC switch on clinical hold - The U.S. Food and Drug Administration informed Sanofi that its planned Actual Use Trial to support the Rx-to-OTC switch for Cialis has been placed on clinical hold due to matters surrounding the protocol design. Sanofi's AUT has not yet recruited any patients. Sanofi said in a statement that it continues to work with FDA to move the Cialis program forward and will engage the Agency in upcoming meetings as we determine next steps.
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SNY | Hot Stocks08:44 EDT Sanofi Rx-to-OTC switch AUT for Cialis placed on clinical hold by FDA - The FDA has informed Sanofi that its planned Actual Use Trial , or AUT, to support the Rx-to-OTC switch for Cialis has been placed on clinical hold due to matters surrounding the protocol design. Sanofi's AUT has not yet recruited any patients. Sanofi continues to work with FDA to move the Cialis program forward and will engage the Agency in upcoming meetings as we determine next steps.
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DE | Hot Stocks08:43 EDT Deere names Raj Kalathur as CFO - Deere announced the election of Raj Kalathur as the company's CFO. He will retain his present duties for John Deere Financial and have continued oversight for information technology. His areas of responsibility as CFO include accounting and reporting, treasury, taxes, internal audit, strategy and business development, sustainability, and investor relations. Prior to assuming his current role, Kalathur was President, John Deere Financial and Chief Information Officer where he led the team responsible for ensuring that John Deere equipment customers throughout the world have ready access to competitive financing. His CIO responsibilities will now be led by Ganesh Jayaram who has been appointed as the Chief Information Officer, effective May 31.
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PHOT | Hot Stocks08:40 EDT GrowLife: Dave Dohrmann to succeed Marco Hegyi as CEO - GrowLife announced that company President Dave Dohrmann will assume the role of CEO of GrowLife. The change is set to become effective on July 1, 2022, following the departure of CEO Marco Hegyi. Dohrmann will also be replacing Marco Hegyi on the GrowLife board of directors. Dohrmann has served as the Company President since December 2021.
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HSDT | Hot Stocks08:40 EDT Helius Medical announces poster to be presented at CMSC annual conference - Helius Medical Technologies announced that an abstract highlighting real-world data, which shows the impact of translingual neurostimulation as a rehabilitation therapy to improve gait in people with multiple sclerosis, MS, has been selected for a poster presentation at the Consortium for Multiple Sclerosis Centers, CMSC, Annual Meeting taking place June 1-4 in National Harbor, Maryland. "We are excited to share our real-world findings on neuromodulation to improve MS patients' ability to walk steadily and safely," said Antonella Favit-Van Pelt, MD, PhD, Helius Medical's Chief Medical Officer. "Our findings show that neuromodulation stimulation is an effective rehabilitative intervention that is thought to engage mechanisms of upregulation and long-term potentiation, promoting neuroplasticity and improving gait functionality and mobility."
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SPRC | Hot Stocks08:39 EDT SciSparc announces collaboration agreement with Polyrizon - SciSparc announced it has signed a collaboration agreement with Polyrizon Ltd., a biotech company focused on the development of innovative medical device hydrogels delivered in the form of nasal sprays. As part of the collaboration, the two companies will work to develop a unique technology for the treatment of pain, based on SciSparc's SCI-160 platform and Polyrizon's Trap and Target intranasal drug delivery technology to target the central nervous system.
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BWV | Hot Stocks08:37 EDT Blue Water announces sponsored research agreement amendment - Blue Water Vaccines announced the signing of an amendment to its existing Sponsored Research Agreement with The University of Oxford. Under this amendment, BWV will extend funding for research into its universal influenza vaccine candidate, BWV-101, for an additional 18 months. Under the original agreement signed in December 2019, BWV agreed to fund research and development of its universal influenza vaccine at The University of Oxford for a period of three years, ending on December 19, 2022. The signing of this amendment, as well as additional funding provided by BWV, will enable Oxford to continue research and optimization of the company's universal influenza vaccine candidate, BWV-101. "We are thrilled to continue our partnership with The University of Oxford," said Joseph Hernandez, Chairman and CEO of Blue Water Vaccines. "In addition to the original work on H1 epitopes of limited variability, the team at Oxford recently found epitopes of limited variability for H3 and influenza B. This work brings us one step closer to a truly universal influenza vaccine, and we look forward to reaching that milestone with our partners at Oxford."
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AZ ACN | Hot Stocks08:37 EDT A2Z Smart Technologies enters strategic partnership with Accenture Italy - A2Z Smart Technologies (AZ) announced that it has entered, through its subsidiary and its European partners, into a partnership agreement with Accenture Italy (ACN) to increase the brand recognition and expand the market presence of the Cust2Mate Smart Cart Platform in Europe. A2Z's state-of-the-art Cust2Mate Smart Cart provides a contactless and convenient shopping experience by recognizing every purchased item and enabling in-cart payment so that shoppers don't have to wait on lines. The platform also allows retail grocers to direct shoppers to discounted products with in-store promotions and collects valuable in-store shopping data to optimize operations and inventory management.
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CCXI AZN | Hot Stocks08:36 EDT ChemoCentryx announces changes to board of directors - ChemoCentryx (CCXI) announced changes to the composition of its Board of Directors. David Wheadon, M.D., has been elected to the Board as an independent director, and Henry McKinnell, Jr., Ph.D., is retiring from the Board, effective May 26, 2022. Dr. Wheadon retired from AstraZeneca (AZN) in 2019 as Senior Vice President, Global Regulatory Affairs, Patient Safety and Quality Assurance, a position he had held since 2014.
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BMRN | Hot Stocks08:36 EDT BioMarin announces updated results from Phase 1/2 study of valoctocogene - BioMarin Pharmaceutical announced updated results from its ongoing open-label Phase 1/2 study, which represents the longest duration of clinical observation for valoctocogene roxaparvovec, an investigational gene therapy treatment for adults with severe hemophilia A. The Company plans to share the data during an oral presentation at the upcoming International Society on Thrombosis and Haemostasis, or ISTH, 2022 Congress. Six-year and five-year post-treatment follow-up of the 6e13 vg/kg and 4e13 vg/kg cohorts, respectively, demonstrated sustained hemostatic efficacy of valoctocogene roxaparvovec. All participants in the 6e13 vg/kg cohort remain off prophylactic Factor VIII treatment at the time of the data cut. The mean cumulative annualized bleed rate (ABR) remains less than one and substantially below baseline levels; the mean ABR in year six was 0.7 with a mean cumulative ABR reduction of 95% and Factor VIII use reduction of 96% through six years, compared to baseline. BioMarin plans to include the previously reported results from the two-year follow-up safety and efficacy data from the Phase 3 GENEr8-1 study in a Biologics Licensing Application resubmission for valoctocogene roxaparvovec to the FDA. Overall, the safety profile of valoctocogene roxaparvovec in the Phase 1/2 study remains consistent with previously reported data with no delayed-onset treatment related adverse events.
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FBIO | Hot Stocks08:35 EDT Fortress Biotech reports first patient dosed in Phase 1 Dotinurad trial - Fortress Biotech announced that its subsidiary company, UR-1 Therapeutics, dosed the first patient in a Phase 1 clinical trial evaluating Dotinurad for the treatment of gout in the United States.The principal objective of this Phase 1 clinical trial is to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of Dotinurad in Western subjects. Subjects will be randomized into a placebo-controlled crossover clinical trial design to evaluate a wide range of Dotinurad doses.Lindsay A. Rosenwald, M.D., Fortress' Chairman and CEO, said, "The successful dosing of the first patient in this Phase 1 clinical trial to evaluate Dotinurad for the treatment of gout is an important milestone for UR-1 and Fortress and we expect to announce topline data in the second half of 2022."
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DXCM PODD | Hot Stocks08:35 EDT DexCom says 'not in active discussions regarding a merger transaction' - DexCom (DXCM) issued the following statement in response to recent media and market speculation: "Like many companies, Dexcom's Board and management team regularly review opportunities to enhance stockholder value and create benefits for customers, including through mergers and acquisitions. It is generally our policy not to comment on rumors or speculation, however, in light of recent sustained media and market speculation as well as the upcoming American Diabetes Association conference, we wish to confirm that Dexcom is not in active discussions regarding a merger transaction at this time. We do not intend to comment further on this topic and we assume no obligation to make any further announcement or disclosure should circumstances change." Bloomberg had reported last week that CGM maker Dexcom was in talks to buy insulin pump maker Insulet (PODD).
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HUGE | Hot Stocks08:35 EDT FSD Pharma files IND for FSD-201 trial for inflammation, gives updates - FSD Pharm announces the submission of an Investigational New Drug application with the U.S. Food and Drug Administration and Health Canada detailing a planned Phase 2 clinical trial of FSD-PEA for the treatment of a yet-to-be-disclosed inflammatory disorder. "Our current submissions of applications to FDA and Health Canada for FSD-201 efficacy trials represent a significant milestone in our drug development efforts," said Zeeshan Saeed, Co-Founder and President of FSD Pharma. "With our elite team and solid cash position, we find ourselves in a strong position initiating the efficacy trials with FSD-201. Further details on the clinical trial will be released as soon as the applications complete their review processes, and the clinical trial commences." FSD Pharma holds exclusive worldwide licensing rights to FSD-201 for all conditions in all regulatory categories. FSD-201 is a proprietary formulation of ultra-micronized palmitoyl ethylamine FSD Pharma's successfully completed Phase 1 clinical trial showed FSD-201 to be safe and well tolerated . FSD Pharma would also like to provide shareholders additional insight as the Company looks ahead to the second half of 2022. On May 6, 2022, FSD Pharma completed the sale of its former cannabis production facility in Cobourg, Ontario, Canada for CAD$16.4 million, growing its cash on hand to approximately CAD$50.0 million and completing its transition away from the cannabis industry to focus on its pipeline of novel therapeutics for inflammatory, neurodegenerative, and neuropsychiatric diseases. "Over the last year, we have strategically exited the cannabis business, whilst making a generous profit on the sale of the Cobourg facility and in the process, providing sufficient capital for at least three years of operations and clinical trials," said Zeeshan Saeed. "No treatment currently exists to target neurodegeneration, Major Depressive Disorder is an indication in desperate need for new therapeutic approaches, and, as aforementioned, there are no PEA-based drugs approved by the FDA either. That said, we have unique drug candidates that have the potential to revolutionize patient outcomes in each of these notoriously hard-to-treat diseases via innovative mechanisms of action."
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ATNF | Hot Stocks08:35 EDT 180 Life begins consultations with UK, US authorities for Dupuytren treatment - 180 Life Sciences announced, following publication of promising data from a Phase 2b Dupuytren's trial in the June 2022 issues of The Lancet Rheumatology, that 180 Life Sciences has initiated preliminary consultations with regulatory agencies in both the UK and USA, with the assistance of Kinexum, the Company's regulatory advisor. At a scientific advice meeting with the Medicines and Healthcare products Regulatory Agency, UK MHRA, on May 18, 2022, the Company presented the results of the Phase 2b trial and received guidance on the path forward for further development. The Company awaits formal feedback from UK MHRA. The U.S. Food and Drug Administration, FDA, has agreed to provide a written response to the Company's briefing materials including the results of the Phase 2B trial, on a Type C meeting request. Guidance from the FDA is expected to shape the Company's clinical development strategy in the USA. "We believe our recent results present the potential for an earlier treatment for patients with Dupuytren's disease, which is easy to diagnose at an early stage," said James Woody, M.D., Chief Executive Officer of 180 Life Sciences, who continued, "We look forward to feedback from the regulatory agencies which we believe may help us bring this potential treatment to patients to prevent the disease from advancing to the stage that surgery is needed to maintain hand function."
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AGEN | Hot Stocks08:34 EDT Agenus announces three new clinical collaborations - Agenus announced that it has entered into 3 new clinical collaborations with Targovax, Oxford BioTherapeutics, and Immunogenesis, doubling its current number of clinical collaborations. These 6 collaborations span a range of Agenus' clinical assets, including botensilimab, balstilimab, zalifrelimab, and QS-21 STIMULON. Agenus' new and ongoing clinical collaborations are supporting and enabling:Targovax to conduct a clinical trial combining botensilimab and balstilimab with ONCOS-102 in patients with PD-1 relapsed/refractory melanoma. ONCOS-102 is designed to induce immune activation and immunogenic cell death to improve response to immunotherapy. Oxford BioTherapeutics to conduct a clinical trial combining balstilimab with OBT076 in patients with solid tumors, including lung, gastric, and ovarian cancer. Immunogenesis to conduct a clinical trial combining balstilimab and zalifrelimab with evofosfamide in patients with advanced solid tumors, including prostate, pancreatic, HPV-negative head and neck cancer. Targovax to conduct a clinical trial combining QS-21 STIMULON with TG01 in up to 3 cancer indications, including multiple myeloma. Rottapharm Biotech is conducting a clinical trial combining balstilimab with CR6086 in patients with pMMR-MSS colorectal cancer. Nelum is conducting a clinical trial combining zalifrelimab with NLM-001 and chemotherapy in patients with advanced pancreatic cancer.
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DXCM | Hot Stocks08:34 EDT DexCom says 'not in active discussions regarding a merger transaction'
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MULN | Hot Stocks08:32 EDT Mullen Automotive announces results from testing with BIC in Indiana - Mullen Automotive announces results of Mullen's solid-state polymer battery testing with the Battery Innovation Center, BIC, in Indiana. Testing results from BIC show the solid-state polymer cell, rated at 300 Ah and 3.7 volts, tested in at 343.28 Ah at 4.2 volts, exceeding expectation and in line with test tolerance from previous EV Grid test results. Testing conducted at Battery Innovation Center, BIC, in Indiana, show Mullen's solid-state polymer cell coming in at 343.28 Ah at 4.2 volts, which is in line with previously quoted test results from EV Grid. In EV Grid's testing, the solid-state battery cell was rated at 300 Ah at 3.7 volts, with the battery yielding 343 Ah at 4.3 volts. The test data collected from both BIC and EV Grid have exceeded expected test tolerance and show an impressive outcome and future for solid-state batteries. It is expected that with this technology, when scaled to the vehicle pack level, a 150-kilowatt hour solid-state battery can deliver over 600 miles of range on a full charge for the Mullen FIVE EV Crossover. In general, solid-state batteries offer higher energy density, faster charging time, smaller size and safety compared to traditional lithium-ion cells. "I'm impressed with the ongoing performance of the solid-state cell after going thru multiple intense testing sessions from accredited testing facilities," said David Michery, CEO and chairman of Mullen Automotive. "The battery has performed exceptionally well, and I'm pleased with the results from BIC in Indiana."
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ARE | Hot Stocks08:32 EDT Alexandria Real Estate raises quarterly dividend to $1.18 from $1.15 per share - Alexandria Real Estate Equities announced that its Board of Directors declared a quarterly cash dividend of $1.18 per common share for the second quarter. The dividend is payable on July 15 to shareholders of record on June 30. The common stock dividend for the 12 months ending June 30 of $4.60 per common share represents an increase of 24c, or 6%, over the 12 months ended June 30, 2021.
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JAN | Hot Stocks08:32 EDT JanOne sells assets of GeoTraq subsidiary for $13.5M - JanOne announced that it has sold substantially all of the assets, and none of the liabilities, of GeoTraq, its wholly-owned subsidiary, to SPYR Technologies. Pursuant to the Asset Purchase Agreement, the aggregate purchase price for GeoTraq was $13.5M, payable in cash and shares of SPYR's common stock. At closing, SPYR issued to JanOne 30,000,000 shares of its common stock and delivered to JanOne a five-year Promissory Note in the initial principal amount of $12.6 million. The Promissory Note bears simple interest at the rate of 8% per annum and provides quarterly interest payments in arrears, which may be prepaid at any time without penalty.
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MAAQ | Hot Stocks08:30 EDT Mana Capital Acquisition Corp trading resumes
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KYKOF | Hot Stocks08:28 EDT Kyowa Kirin, InveniAI announce achievement of milestone in collaboration - InveniAI and Kyowa Kirin announced the achievement of the first milestone in disease model systems that triggered a milestone payment that has been received by InveniAI under the research collaboration between the companies. Yoshifumi Torii, Ph.D., Executive Officer, Vice President, and Head of R&D Division of Kyowa Kirin, added, "We are excited to achieve a successful outcome by leveraging InveniAI's platform AlphaMeld(R) that detected very early signals of association between targets/mechanism of action and clinical utility based on the platform's analytics. We have since validated this program which, as predicted, has shown signals of efficacy in preclinical proof-of-concept studies for the treatment of a disease indication where current therapeutic options lack efficacy and have adverse effects. We are eager to test this very promising candidate for further studies. We also look forward to the selection of additional novel programs identified by InveniAI's truly game-changing platform and believe that our collaboration will contribute to addressing enduring unmet medical needs."
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SDC | Hot Stocks08:27 EDT SmileDirectClub appoints Williams to board of directors - SmileDirectClub announced the appointment of Linda Williams as an independent director on its Board of Directors. Her appointment as an independent director will be effective June 3, 2022, immediately following the Company's annual meeting of stockholders to be held on the same date. Williams currently serves as the Senior Vice President and Chief Risk and Audit Executive at Blue Cross Blue Shield of Massachusetts where she leads audit efforts and provides oversight of investments and enterprise level business risks including cybersecurity.
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ABM | Hot Stocks08:26 EDT ABM launches business ventures program - ABM announced the establishment of ABM Ventures, the company's business venture program, and an important extension of its ELEVATE strategy to accelerate growth through investments in both client and team member experiences and industry leading use of technology and data. ABM Ventures will explore new strategic growth opportunities and quicken the innovation cycle through investments primarily in growth-stage companies that are solving for the facility services industry's biggest challenges, including sustainability, virtual and digital workplace services and e-mobility, the company said in a statement.
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OTLK | Hot Stocks08:26 EDT Outlook Therapeutics: FDA requests more information on ONS-5010 BLA - Outlook Therapeutics announced that the U.S. FDA has requested additional information in order to complete the filing of the company's Biologics License Application for ONS-5010/ LYTENAVA for the treatment of wet age-related macular degeneration. Outlook Therapeutics has voluntarily withdrawn its BLA for ONS-5010 and is actively working to respond to the FDA's request. The Company plans to re-submit a revised BLA by September 2022. Russell Trenary, President and CEO of Outlook Therapeutics, commented, "We remain confident in ONS-5010 and its potential to be the first FDA-approved ophthalmic formulation of bevacizumab that avoids the public health risk to patients of off-label treatment of bevacizumab that was never approved for any ophthalmic indications. We are continuing to have productive discussions with the FDA and are committed to providing the additional information necessary to support the application. We look forward to a successful resubmission and ultimately the potential approval of ONS-5010 for the treatment of wet AMD. We also look forward to a future where virtually all retina patients treated with bevacizumab are receiving an FDA-approved ophthalmic therapy." Based on a compilation of the data from its previously completed clinical trials - NORSE ONE, NORSE TWO and NORSE THREE - Outlook Therapeutics submitted the BLA to the FDA in March 2022. NORSE ONE, a proof-of-concept and clinical experience trial, helped validate the protocols and approach for NORSE TWO, the pivotal safety and efficacy trial. The NORSE TWO data were statistically significant and clinically relevant for the primary and all secondary endpoints. NORSE THREE was an open-label supplementary safety trial conducted to ensure that a sufficient number of patients had been dosed with ONS-5010 ophthalmic bevacizumab to support the regulatory submission.
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UGRO | Hot Stocks08:24 EDT Urban-Gro signs MOU for turn-key design build of facility in New York with E29 - urban-gro announced that it has signed an agreement with E29 Labs to provide full architecture, engineering and design services for their application to build an approximately 100,000 square foot cannabis production facility located in New York State. Upon securing a license, the agreement provides that urban-gro will be E29 Labs' design-build partner to complete the build out of its facility. Shelley Roberts, CEO of E29 Labs, commented, "We are looking forward to working with urban-gro to access their deep experience and expertise in indoor CEA as we plan for our high-performance facility. We're excited to leverage urban-gro's turn-key design-build capabilities as we revitalize a dormant industrial site into a productive, vibrant development that integrates with the existing fabric of the historic Village of Canajoharie. As a socially conscious business, our goal is to be a force for improving lives and fostering sustainable community renewal through economic opportunity."
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ESPR | Hot Stocks08:24 EDT Esperion announces five abstracts accepted for presentation at NLA 2022 - Esperion announced five abstracts have been accepted for presentation at the National Lipid Association Scientific Sessions, NLA 2022 Scientific Sessions, being held in-person in Scottsdale, Arizona. "In the wake of the pandemic, the US is in serious risk of moving backward on critical public health initiatives like maintaining a healthy cholesterol and metabolic profile. We believe Esperion is uniquely positioned to help address this issue with our approved therapies," said Sheldon Koenig, president and chief executive officer of Esperion. "That is one reason we are presenting our real-world analysis on the major gaps in cardiovascular and metabolic care in advance of readouts from our upcoming pivotal CLEAR Outcomes study."
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DZSI | Hot Stocks08:23 EDT DZS completes acquisition of assets from ASSIA - DZS announced it has closed the acquisition of specific core assets of Adaptive Spectrum and Signal Alignment. As part of the transaction, DZS has gained an elite team of highly skilled cloud and AI software engineers, architects and business leaders, as well as the Expresse service assurance and CloudCheck WiFi experience management solutions deployed by leadingtier 1 operators globally. The acquired assets also include patents and patents pending related to the CloudCheck software portfolio. This all-cash acquisition expands the DZS Cloud platform's recurring Software-as-a-Service revenue and will accelerate the previously stated DZS target margin expansion timeline. The acquisition is accretive to DZS adjusted gross margin, adjusted EBITDA margin and non-GAAP EPS.
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ENLV | Hot Stocks08:21 EDT Enlivex data shows improvements in survival with Allocetra, anti-PD1 - Enlivex Therapeutics announced new preclinical data from an ovarian cancer study conducted in collaboration with Yale Cancer Center. The study showed substantial and statistically significant improvements in survival benefit, survival duration and tumor burden reduction when Allocetra was combined with an anti-PD1 checkpoint inhibitor. The data will be featured in an upcoming poster presentation at the ASCO Annual Meeting, which is taking place both virtually and in-person at the McCormick Place convention center in Chicago, Illinois from June 3 - 7, 2022. The upcoming ASCO poster will also highlight a prior preclinical study in mesothelioma cancer that showed a substantial survival benefit when Allocetra was combined with a commercially approved anti-CTLA4 checkpoint inhibitor. Previously reported preclinical data in peritoneal cancer that show a substantial survival benefit when Allocetra is combined with chimeric antigen receptor T-cell therapy will also be presented.
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DNLI BIIB | Hot Stocks08:21 EDT Denali Therapeutics, Biogen announce initiation of Phase 2b study of BIIB122 - Denali Therapeutics (DNLI), and Biogen (BIIB) announced that dosing has commenced in the global Phase 2b LUMA study to evaluate the efficacy and safety of BIIB122, or DNL151, as compared to placebo in approximately 640 participants with early-stage Parkinson's disease. LUMA is a Phase 2b multi-center, randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of BIIB122 in people with early-stage Parkinson's disease between the ages of 30 and 80. The primary endpoint of LUMA is Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale parts II and III combined score over the treatment period. Participants will be randomized to receive oral BIIB122 or placebo once daily. BIIB122 is an investigational small molecule inhibitor of LRRK2 that was discovered and developed by Denali. Denali and Biogen are co-developing and co-commercializing BIIB122 for the potential treatment of Parkinson's disease. The BIIB122 clinical development program includes both the LUMA Phase 2b study and the Phase 3 LIGHTHOUSE study in individuals with Parkinson's disease with LRRK2 pathogenic variants.
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PXS | Hot Stocks08:20 EDT Pyxis Tankers regains compliance with Nadaq's minimum bid price requirement - Pyxis Tankers announced that it has regained compliance with the minimum bid price requirement under the continued listing requirements of the Nasdaq Stock Market. On May 27, 2022, the company received a written notification from Nasdaq's Listing Qualifications Department stating that the closing bid price of the company's common shares has been $1.00 per share or higher for ten consecutive trading days, from May 13, 2022 to May 26, 2022. Accordingly, the company has regained compliance with the exchange's minimum bid price rule. Separately, the company continued its mixed chartering strategy with three of its medium range product tankers employed in the spot market and two of its MR tankers employed under short-term time charters. Chartering conditions remain robust, and as of May 30, 2022, approximately 77% of the company's available days in second quarter of 2022 were booked for the Company's MR tankers at an average estimated daily Time Charter Equivalent rate of approximately $27,500.
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BREZ | Hot Stocks08:19 EDT D-Orbit secures additional launch ports with SpaceX for 2023 rideshare missions - D-Orbit, the space logistics and orbital transportation company that is going public through a transaction with Breeze Holdings Acquisition Corp., announced that it has secured 11 ports for D-Orbit's ION Satellite Carrier for launch on SpaceX Rideshare missions in 2023. Securing these slots is in line with D-Orbit's plans to launch 13 IONs in 2023, as the Ccompany works to meet the increasing demand for last-mile space transportation solutions and in-orbit demonstration of third-party payloads.
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MFGCF | Hot Stocks08:18 EDT Mayfair Gold's Fenn-Gib Canada's first carbon neutral gold project - Mayfair Gold announces that the 100 percent controlled Fenn-Gib Projec is now Canada's first carbon neutral gold project following the completion of carbon offset purchases to account for emissions from Company-wide activities undertaken during 2021, the Company's first year of operations. Located in the Timmins region of Northeast Ontario, Fenn-Gib hosts a NI43-101 Indicated Resource of 2.08M ounces with disseminated gold mineralization striking east-west on the Pipestone Fault over 1.25 kilometers and up to 300 meters wide at the west end. Mayfair Gold President and CEO Patrick Evans commented: "Gold is Canada's most valuable mined commodity, valued in excess of $12 billion annually. The industry is a significant driver of economic activity across Canada, directly employing approx. 400,000 Canadians and offering the highest average annual industrial rate of pay in the country. The future of the industry depends critically upon sustainable development. At Fenn-Gib, we are laying the foundation for Canada's first carbon neutral gold mine. Our commitment started on January 1, 2021, when Mayfair acquired Fenn-Gib, and will continue through our exploration program, mine development, operations and eventual closure."
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SGHT | Hot Stocks08:18 EDT Sight Sciences' OMNI reduces IOP as shown in 12-month clinical data - Sight Sciences announced publication in Clinical Ophthalmology of its 12-month outcomes in the GEMINI study, including results from a Hispanic population subset. The final study results demonstrated that canaloplasty and trabeculotomy performed as an implant-free minimally invasive glaucoma surgery using the OMNI Surgical System in conjunction with cataract surgery significantly reduced unmedicated mean diurnal intraocular pressure, medication use and daily fluctuations in IOP in patients with open-angle glaucoma. The GEMINI study exhibited a mean unmedicated diurnal IOP reduction of 35%, from 23.8 mmHg at baseline to 15.6 at month 12 and a medication reduction of 80% from 1.8 at baseline to 0.4 at month 12. At month 12, 84.2% of eyes achieved IOP reductions greater than 20% from baseline, 80% of eyes were medication-free, and 76% of eyes achieved IOP between 6- 18 mmHg, inclusive. In a post hoc analysis, a reduction in the variation and amplitude of mean IOP was observed at each diurnal time point evaluated. In the study, 95% of patients had a diminished peak IOP postoperatively when compared to preoperative measurements. The difference between "high" and "low" IOP at 12 months reduced an average of 36% compared to preoperative measurements. Suppression of diurnal, or daily, fluctuations in IOP, is a significant and independent risk factor for the progression of glaucoma. In the Hispanic population subset of the GEMINI study, the unmedicated mean diurnal IOP was reduced from 22.8 mmHg (2.5) to 14.9 (3.6) at 12 months - also a 35% reduction, as with the larger study
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MAAQ | Hot Stocks08:18 EDT Cardio Diagnostics to become public through Mana Capital Acquisition deal - Cardio Diagnostics and Mana Capital Acquisition (MAAQ) announced that they have entered into a definitive business combination agreement that will result in Cardio Diagnostics becoming a publicly listed company. Upon closing of the transaction, Mana will be renamed Cardio Diagnostics and it expects to remain listed on the Nasdaq Global Market under a new ticker symbol (CDIO). Founded in 2017, Cardio Diagnostics' mission is to help physicians better detect and treat cardiovascular disease, the leading cause of death in the United States. At the core of the company's cardiovascular solutions is a proprietary Integrated Genetic-Epigenetic Engine created at the University of Iowa by company founders Meesha Dogan and Rob Philibert. This technology enables the development of a series of tests for precision prevention, early detection, and assists in personalized treatment of major types of cardiovascular diseases and associated co-morbidities. Cardio Diagnostics' flagship product, Epi+Gen CHD, is a clinical test that was recently commercialized to assess the three-year risk for coronary heart disease, the most common type of heart disease and the primary cause of heart attacks. This highly sensitive and accessible test that profiles a panel of genetic and epigenetic biomarkers is radiation-free, does not require fasting and is associated with cost savings per quality-adjusted life year and improved survival. The combined company is expected to have an approximate post-transaction equity market capitalization of $175M assuming no redemptions. Cardio Diagnostics is expected to have approximately $10M in gross proceeds raised in 2022 from common stock equity investors prior to closing. Cardio Diagnostics' cash on the balance sheet prior to closing is expected to fund the combined company's operations through the end of 2023; net proceeds raised in conjunction with the transaction will be used to support the growth strategy. Current Cardio Diagnostics management, employees and existing shareholders will roll 100% of their existing equity holdings into equity of the combined company. Depending on levels of redemptions, existing Cardio Diagnostics security holders will receive between 52% and 85% of the pro forma equity as part of the transaction. The business combination has been approved by the boards of directors of both Mana and Cardio Diagnostics, and is expected to close in the second half of 2022, subject to regulatory and stockholder approvals and other customary closing conditions.
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KTOS | Hot Stocks08:17 EDT Kratos Defense's satellite ground platform selected by Intelsat - Kratos Defense & Security Solutions announced that its OpenSpace Platform has been selected by Intelsat, operator of the world's largest satellite services business, as a key component to unify the operations of its ground and space systems in its next generation network. Intelsat's next generation network will combine the latest in space, ground and cloud technologies to deliver robust, dynamic and flexible services to their customers. Kratos' OpenSpace Platform is the first and only software-defined satellite ground system. Fully virtualized and orchestrated, and built upon widely accepted industry standards, OpenSpace enables scalable deployment within an elastic, cloud-agnostic environment. With the OpenSpace Platform, Intelsat will be able to instantiate carrier-grade services in minutes instead of the weeks or even months commonly required with traditional hardware-based ground systems, allowing its customers to quickly deploy services and make service changes to meet evolving user needs.
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LXRX | Hot Stocks08:16 EDT Lexicon resubmits NDA for Sotagliflozin for treatment of heart failure - Lexicon Pharmaceuticals announced that it has resubmitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of sotagliflozin for the treatment of heart failure. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. "The resubmission of our NDA places us a step closer to the possibility of bringing this innovative new investigational treatment to heart failure patients," said Lonnel Coats, Lexicon's chief executive officer. "We believe sotagliflozin's dual SGLT1 and SGLT2 mechanism and the data from our SOLOIST-WHF and SCORED Phase 3 trials address important areas of need in the treatment of heart failure. We look forward to working closely with the FDA during the review process." The NDA submission is supported by the results from the Phase 3 SOLOIST-WHF clinical study in patients with type 2 diabetes who had recently been hospitalized for worsening heart failure and the Phase 3 SCORED clinical study in patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease.
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MDXG | Hot Stocks08:15 EDT MiMedx receives $4.6M awarded from DoD - MiMedx Group announced receiving a $4.6M award to evaluate PURION processed Dehydrated Human Amnion Chorion Membrane as an advanced treatment option for wound and burn care. The award from the Medical Technology Enterprise Consortium, a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement with the U.S. Army Medical Research and Development Command, is sponsored and will be managed by the Naval Medical Research Center to advance medical treatments for combat wounds and burns.
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TMBR | Hot Stocks08:14 EDT Timber Pharmaceuticals receives FDA Breakthrough Therapy designation to TMB-001 - Timber Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy designation to TMB-001, a topical isotretinoin formulated using the Company's patented IPEG delivery system, for the treatment of congenital ichthyosis, CI. "This is a significant moment for people who are living with CI, their families and caregivers, and clinicians and researchers who have been working for years to find new treatment options for this debilitating condition," said John Koconis, Chairman and Chief Executive Officer of Timber. "A Breakthrough Therapy designation is no small achievement. Through half of FDA's 2022 fiscal year, more breakthrough applications have been rejected by FDA or withdrawn (16), than have been granted (9). I am proud of our team for demonstrating the potential of TMB-001 in our Phase 2b program, and we are rapidly pushing forward with a pivotal Phase 3 clinical trial." Timber is developing TMB-001 for the treatment of moderate to severe forms of CI, including X-linked recessive ichthyosis and autosomal recessive congenital ichthyosis lamellar ichthyosis. CI is a group of rare genetic keratinization disorders that lead to dry, thickened, and scaling skin. In patients with XRI and ARCI-LI, cutaneous manifestations include large, dark scaling throughout the body.
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PDSB MRK | Hot Stocks08:13 EDT PDS Biotechnology announces expansion of Versatile-002 trial into Europe - PDS Biotechnology Corporation (PDSB) announced the acceptance of its Clinical Trial Application from the Medicines and Healthcare products Regulatory Agency in the United Kingdom to allow expansion of its VERSATILE-002 study of PDS0101 in combination with Merck's (MRK) anti-PD-1 therapy KEYTRUDA to the UK. The MHRA is among several regulatory agencies that PDS Biotech is seeking approval from to expand the trial into various sites outside of the United States. PDS Biotech anticipates that enrollment in the UK could begin during the third quarter of 2022. "The acceptance of this CTA marks another important regulatory milestone for PDS Biotech. Initiation of our global expansion is a key advancement to expedite enrollment into the VERSATILE-002 clinical study," stated Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "Additionally, this expansion allows PDS to expose global regulators to our novel molecularly targeted immunotherapies."
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SIBN | Hot Stocks08:13 EDT SI-Bone receives FDA 510(k) clearance for iFuse Bedrock Granite - SI-BONE announces FDA 510(k) premarket clearance of the iFuse Bedrock Granite Implant System. The Granite implant provides sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion. This clearance follows the earlier designation by the Food & Drug Administration, FDA, of Granite as a Breakthrough Device, BDD, and most recently, a proposal by the Centers for Medicare and Medicaid Services, CMS, for a New Technology Add-on Payment, NTAP. CMS has also issued new technology "Section X" ICD-10 unique procedure coding for hospitals to report NTAP eligible cases that use Granite as an Internal Fixation Device with Tulip Connector, for either open or percutaneous sacroiliac joint fusion and sacropelvic fixation. "We are thrilled to receive FDA 510(k) clearance to launch Granite to the market. The anticipation has been building ever since the FDA awarded BDD for its promise of providing more effective treatment than the current standard of care, and CMS' recently proposed NTAP, recognizing it as a new technology that can provide substantial clinical improvement over already available therapies," said Laura Francis, CEO of SI-BONE. "Based on the early pre-clinical data from in vivo animal studies suggesting significant bone ingrowth and superior mechanical stability, internal studies showing markedly improved biomechanics, and initial feedback from surgeons, we couldn't be more enthusiastic about Granite's clinical and commercial promise as a uniquely disruptive technology."
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IMAX PARA | Hot Stocks08:12 EDT Imax announces best ever global four-day Memorial Day Weekend opening - Imax (IMAX) soared to its best global four-day Memorial Day Weekend opening ever with the $32.5M debut of Paramount Pictures' (PARA) "Top Gun: Maverick", starring cinema icon Tom Cruise. Crushing industry expectations, the aerial actioner also scored the biggest domestic four-day Memorial Day Weekend opening ever in IMAX with $21M, good for a stunning 14% of the overall North American box office.
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JANX | Hot Stocks08:11 EDT Janux announces FDA clearance of JANX007 IND for mCRPC treatment - Janux Therapeutics announced that the U.S. Food and Drug Administration has cleared the Company's investigational new drug application for its lead product candidate, JANX007, a PSMA-TRACTr in development for the treatment of metastatic castration-resistant prostate cancer. JANX007 is the Company's lead novel T cell engager therapeutic from its TRACTr platform. Janux plans to initiate a Phase 1 clinical trial for JANX007 in the second half of 2022. "We are proud to announce today the clearance of Janux's first IND - a critical milestone for our TRACTr platform and for the Company as we advance a broad pipeline of next generation immunotherapies to address unmet needs and improve the treatment of cancer," said David Campbell, Ph.D., President and CEO of Janux. "JANX007 is uniquely designed to overcome the clinical limitations of existing TCE approaches, potentially providing mCRPC patients a safer therapeutic option, while also generating potent anti-tumor activity by enabling the delivery of a higher concentration of active drug. With this IND acceptance, we are on track to advance JANX007 into the clinic in the second half of this year." Unlike existing TCE approaches to prostate cancer that have been limited to-date by dose-limiting toxicities, poor pharmacokinetic profiles and attenuated efficacy, JANX007 is designed as a safer, highly potent anti-tumor approach to mCRPC. In preclinical studies, JANX007 was well tolerated in non-human primates with limited healthy tissue toxicities and cytokine release syndrome and exhibited enhanced safety and PK properties relative to unmasked TCEs. These data along with the superior manufacturability properties of JANX007 support its further development as an attractive mCRPC therapeutic.
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RELI | Hot Stocks08:11 EDT Reliance Global names William Lebovics as CFO - Reliance Global Group announced the appointment of William Lebovics as CFO, effective June 1, 2022. Blumenfrucht, who previously served as CFO, will continue as a member of the company's Board of Directors and will provide support through the transition period.
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ENPH | Hot Stocks08:11 EDT Enphase Energy expands home solar, battery storage deployments in Germany - Enphase Energy announced that installers of Enphase products in Germany have seen growing deployments of Enphase Energy Systems powered by IQ Microinverters and IQ Batteries. This growth comes as the region faces rising energy prices and growing demand for electrification. Enphase announced the launch of the IQ Battery in Germany last June, the product's first market expansion outside of the United States. Enphase also recently announced that IQ Batteries will now support third-party inverters in Europe, further enabling the growth of Enphase's business in Germany to help meet installer and homeowner needs for a safe and reliable all-in-one home energy solution. This growth in Germany will be further supported by Enphase's strategic agreements with several installation partners, including German climate tech startup 1KOMMA5. The partnership with 1KOMMA5 aims to extend Enphase's footprint in Germany and other European markets while also extending energy trading benefits to Enphase's customers via 1KOMMA5 virtual power plant applications.
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ALLG | Hot Stocks08:10 EDT Allego announces strategic partnership with ATU in Germany - Allego announced a strategic partnership with ATU. With this agreement in place the EV charging infrastructure roll out in Germany is about to get an enormously strong boost: ATU and Allego have agreed to equip an additional 400 ATU branch locations with e-charging stations. This nationwide project and charging network is to begin as early as this year. Specifically, the partnership provides for the installation of fast charging stations at 400 ATU stores totaling around 900 charging points.
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EAR | Hot Stocks08:10 EDT Nasdaq confirms continued listing of Eargo stock - Eargo announced that it received a letter from The Nasdaq Stock Market LLC dated May 26, 2022 informing Eargo that the company's filing delinquency for the period ended March 31, 2022 has been cured, that the scheduled hearing on June 16, 2022 has been cancelled, that the Nasdaq matter regarding the listing of Eargo's securities is now closed and that Eargo's stock will continue to be listed and traded on Nasdaq. The letter from Nasdaq follows the company's filing on May 24, 2022 of its Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, which made the company current in its filing obligations with the U.S. Securities and Exchange Commission. Christian Gormsen, President and CEO, said, "Becoming current on our SEC filings is yet another example of our people's tenacity. We are thrilled to achieve this milestone and excited to continue focusing on our operational execution, growth, and passion to help more people hear better."
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RAD | Hot Stocks08:10 EDT Rite Aid, Homeward announce partnership to serve rural areas - Homeward, a company committed to improving access to high-quality, comprehensive care in rural communities, announced a strategic partnership with Rite Aid to provide access to comprehensive care for those living in rural areas across the U.S. Beginning this summer, Homeward and Rite Aid will partner to connect underserved seniors with providers and other clinical services. Rite Aid pharmacists will be able to introduce Medicare-eligible customers to Homeward's clinical services, including annual wellness visits, screenings, and risk assessments. In addition, Rite Aid will host Homeward's mobile care units at select rural Michigan locations to provide care and services to underserved communities with the goal of expanding to additional markets nationwide.
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AADI PSTX | Hot Stocks08:10 EDT Aadi Bioscience appoints Graham as SVP, IR, Corporates Communications - Aadi Bioscience (AADI) announced the appointment of Marcy Graham to the new position of Senior Vice President, SVP, Investor Relations, IR, and Corporate Communications. Graham brings more than 20 years of biotech and pharma-specific investor relations and corporate communications experience, leading these functional areas at companies in all stages of development. She joins Aadi after most recently serving as the Vice President of Corporate Affairs at Poseida Therapeutics (PSTX).
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IMAB | Hot Stocks08:08 EDT I-Mab completes patient enrollment in Phase 3 clinical trial of eftansomatropin - I-Mab announced the completion of patient enrollment in a Phase 3 clinical trial, or TALLER, of highly differentiated long-acting recombinant human growth hormone eftansomatropin alfa which is being investigated as a weekly treatment for pediatric growth hormone deficiency, or PGHD, in China. The primary endpoint is annual height velocity. TALLER is a multi-center, randomized, open-label, active-controlled phase 3 clinical study that has enrolled 168 patients in China. The study aims to evaluate the efficacy, safety, and pharmacokinetics of eftansomatropin alfa in PGHD, as compared to Norditropin(R), a daily rhGH marketed in China.
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GRTS BMY | Hot Stocks08:08 EDT Gritstone announces updates OS results from Phase 1/2 study of GRANITE - Gritstone bio (GRTS) announced updated overall survival, OS, results from its Phase 1/2 study evaluating GRANITE, an individualized vaccine-based immunotherapy, to treat advanced solid tumors. Additionally, the company announced it is presenting a "Trial in Progress" poster summarizing the Phase 2/3 GRANITE-CRC-1L- study at the 2022 American Society for Clinical Oncology, ASCO, Annual Meeting. The Phase 1/2 study is evaluating the safety, immunogenicity, and clinical activity of GRANITE in combination with PD-1 checkpoint inhibitor, Opdivo and subcutaneous anti-CTLA-4 antibody, Yervoy in advanced solid tumors. This study enrolled and treated 26 patients as of ESMO 2021 presentation with previously treated, metastatic solid tumors including patients with colorectal cancer, gastroesophageal adenocarcinoma, and non-small cell lung cancer. As presented at ESMO 2021, of 9 patients with MSS-CRC who were treated and evaluable for molecular response, 4 experienced a molecular response and continue to have an OS advantage compared to those patients who did not have a molecular response. Opdivo and Yervoy are trademarks of Bristol-Myers Squibb Company (BMY). Updated overall survival data from GRANITE Phase 1/2: 4 of 9 treated patients with MSS-CRC had a molecular response and the observed median overall survival in this group will now exceed 18 months. All patients with MSS-CRC assessed for molecular response and alive at the time of the ESMO 2021 data presentation remain alive after an additional 35 weeks of follow-up.
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CGEM | Hot Stocks08:07 EDT Cullinan data shows median duration of response over 21 months in Phase 1/2a - Cullinan Oncology announced updated clinical research highlighting the therapeutic potential of CLN-081 in patients with epidermal growth factor receptor exon 20 insertion mutation positive non-small cell lung cancer. Findings will be presented on Friday, June 3 at the 2022 American Society of Clinical Oncology Annual Meeting as an oral presentation during the "Lung Cancer - Non-Small Cell Metastatic" session from 4:12- 4:24 p.m. CT. CLN-081 is being evaluated in an ongoing Phase 1/2a clinical trial in patients with NSCLC whose tumors harbor EGFR exon 20 insertion mutations that have progressed on or after prior therapy. As of May 2022, 73 patients have been treated across doses ranging from 30 to 150 mg twice daily. Of the patients enrolled, 66% of patients had received two or more prior lines of treatment; 36% of patients had prior EGFR tyrosine kinase inhibitor treatment, 55% of patients had received prior immunotherapy. Among the 73 patients treated across all dose levels, 28 had confirmed partial response, 42 had stable disease and 3 had progressive disease according to RECIST guidelines. Of the 39 patients in the 100 mg BID dose group: 16 had a confirmed partial response. The estimated median duration of response was greater than 21 months. Median progression-free survival was 12 months. "These data demonstrate a high response rate, improved response durability over standard of care treatment, and favorable safety and tolerability, supporting the rationale for CLN-081 in patients with NSCLC whose tumors harbor EGFR exon 20 insertion mutations," said Helena Yu, MD, Memorial Sloan Kettering. "These data demonstrate the potential for improvement upon the standard of care with effective and less toxic novel therapies to treat NSCLC harboring EGFR exon 20 insertion mutations where patients tend to have poorer outcomes than those with more common EGFR mutations."
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VNRX | Hot Stocks08:06 EDT VolitionRx's Nu.Q NETs achieves CE mark for detection and evaluation of NETosis - VolitionRx has announced that its Nu.Q NETs test has been CE marked for the detection and evaluation of NETosis, enabling clinical use in more than 27 countries across Europe. NETosis is a unique form of cell death that is characterized by the release of neutrophil extracellular traps, or NETs, composed of decondensed chromatin, that trap and kill bacteria and viral particles. Although NETs play an important role in our immune system, excessive production can lead to tissue damage and, in severe cases, sepsis, shock, and death.
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ZLAB | Hot Stocks08:06 EDT Zai Lab to present new PRIME subgroup analysis for niraparib - Zai Lab announced the presentation of a new subgroup data analysis from the Phase 3 PRIME study for niraparib in women in China with ovarian cancer at the upcoming 2022 American Society of Clinical Oncology, ASCO, Annual Meeting in Chicago, June 3-7, 2022. Since patient response to chemotherapy is associated with ovarian cancer prognosis, this subgroup analysis explores the treatment effect of niraparib maintenance therapy in patients with advanced ovarian cancer based on first-line platinum-based chemotherapy response. This presentation highlights a new prespecified subgroup analysis examining 384 newly diagnosed stage III or IV ovarian cancer patients enrolled in the PRIME study, who also experienced a complete response or partial response to first-line platinum-based chemotherapy. The median progression-free survival was measured at 29.4 months for niraparib vs 8.3 months for placebo in the complete response group. In the partial response group, the results showed median progression-free survival of 19.3 months for niraparib versus 8.3 months for placebo. The safety profile of niraparib was consistent with previous clinical trials, with no new safety issues identified in this subgroup analysis. "Since response to chemotherapy is closely associated with the long-term outcome of advanced ovarian cancer, we are proud to present this data analysis showing the effect of niraparib on progression-free survival in patients who responded to first-line platinum-based chemotherapy," said Alan Sandler, M.D., President and Head of Global Development, Oncology, Zai Lab. "This study helps us better understand advanced ovarian cancer regarding a potential treatment for women newly diagnosed with this serious disease."
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LDOS | Hot Stocks08:05 EDT Leidos unit awarded two prime contracts worth up to $1.7B - QTC Medical Services, a Leidos company, was recently awarded two prime contracts to provide medical disability examination services to both veterans and separating or retiring service members. The indefinite delivery/indefinite quantity, firm-fixed-price contracts were awarded by the Veterans Benefits Administration, Medical Disability Examination Office. The contracts each have six-month base periods of performance with six one-year options and a combined estimated value of $1.7B, if all options are exercised.
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CYBN | Hot Stocks08:05 EDT Cybin submits IND for 1st in human trial for CYB003 in MDD treatment - Cybin announces the submission of an Investigational New Drug application to the U.S. Food and Drug Administration for its Phase 1/2a first-in-human clinical trial evaluating a proprietary deuterated psilocybin analog, for the treatment of major depressive disorder . "Following the successful completion of our IND-enabling work just last month, we are very excited to have reached this major milestone toward advancing CYB003 into clinical development so quickly. Based on preclinical studies, our proprietary psilocybin analog has the potential to offer numerous advantages over classic psilocybin with the potential to ultimately provide better outcomes for people suffering with MDD," said Doug Drysdale, Chief Executive Officer of Cybin. "This FDA submission is the next major step in the advancement of CYB003, and we continue to work tirelessly to bring this innovative therapeutic option to people as quickly as possible. We look forward to continuing to work with the FDA to initiate the Phase 1/2a trial in mid-2022."
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ABT | Hot Stocks08:03 EDT Abbott announces FDA cleared its FreeStyle Libre 3 system - Abbott announced the FDA cleared its FreeStyle Libre 3 system for use by people four years and older living with diabetes. FreeStyle Libre 3 System Features: Greatest accuracy, with a 7.9% overall mean absolute relative difference, the FreeStyle Libre 3 system is the most accurate 14-day continuous glucose monitor with readings sent directly to a smartphone every minute. It's the first CGM to demonstrate a sub-8% MARD1,6 - which is the standard way to measure continuous glucose accuracy - the lower percentage, the better. Smallest and thinnest - at the size of two stacked U.S. pennies, it's the smallest and thinnest4,7 CGM sensor in the world. Even easier to use - with a one-piece applicator the sensor is uncomplicated to apply. Strongest Bluetooth integration with a range of up to 33 feet - 50% further range than other CGMs.4,8.
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LPSN | Hot Stocks08:03 EDT Starboard Value delivers open letter to LivePerson stockholders - Starboard Value LP, one of the largest stockholders of LivePerson, with an ownership interest of approximately 9.4% of the company's outstanding shares, today announced that it has delivered an open letter to LivePerson stockholders. Reference Link
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MAAQ | Hot Stocks07:55 EDT Mana Capital Acquisition Corp trading halted, news pending
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AXSM | Hot Stocks07:45 EDT Axsome Therapeutics announces publication of GEMINI Phase 3 trial of AXS-05 - Axsome Therapeutics announced the publication on May 30, 2022 of the results from the pivotal GEMINI Phase 3 clinical trial of AXS-05 in major depressive disorder, MDD. AXS-05 is a novel, oral, investigational N-methyl-D-aspartate receptor antagonist with multimodal activity. The article, "Efficacy and Safety of AXS-05 in Patients with Major Depressive Disorder: A Phase 3 Randomized Clinical Trial," was published in The Journal of Clinical Psychiatry. The GEMINI trial assessed the efficacy and safety of AXS-05 versus placebo in patients with MDD. A total of 327 patients with a confirmed diagnosis of moderate to severe MDD were randomized to receive AXS-05, or placebo, once daily for the first 3 days and twice daily thereafter, for a total of 6 weeks. The primary endpoint was the change on the Montgomery-Asberg Depression Rating Scale score from baseline to week 6. The key secondary endpoints were the change from baseline in the MADRS total score at week 1, change from baseline in the MADRS total score at week 2, remission on the MADRS at week 2, and clinical response on the MADRS at week 6. In the trial, AXS-05 demonstrated rapid, substantial, and statistically significant improvement in depressive symptoms and induction of remission compared with placebo. The change from baseline in MADRS score to week 6 was significantly greater with AXS-05 than with placebo. The MADRS score change with AXS-05 was significantly greater than placebo at week 1, the first timepoint, and at every timepoint thereafter. Remission rates were significantly greater with AXS-05 at week 2 and every timepoint thereafter. The majority of secondary outcomes favored AXS-05. Results for most other secondary endpoints were significantly better with AXS-05 than with placebo at almost all timepoints.
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GFAI | Hot Stocks07:44 EDT Guardforce receives notification letter from Nasdaq Stock Market - Guardforce AI announced that it has received a notification letter from the Nasdaq Stock Market dated May 27, 2022, notifying the Company that it is not in compliance with the minimum bid price requirement as set forth under NASDAQ Listing Rule 5550(a)(2) for continued listing on the NASDAQ. This press release is issued pursuant to NASDAQ Listing Rule 5810(b), which requires prompt disclosure upon the receipt of a deficiency notification. NASDAQ Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of US$1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company's ordinary shares for the 30 consecutive business days from April 14, 2022 through May 26, 2022 the Company no longer meets the minimum bid price requirement. In accordance with the NASDAQ Listing Rule 5810(c)(3)(A), the Company has been provided 180 calendar days, or until November 23, 2022, to regain compliance with NASDAQ Listing Rule 5550(a)(2).
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GFAI | Hot Stocks07:44 EDT Guardforce extends contract with government savings bank in Thailand - Guardforce AI announced that Guardforce Cash Solutions Security Company Limited, the secured logistic subsidiary of Guardforce AI, has extended its contract as the automated teller machine, ATM, service provider for Government Savings Bank, GSB, in Thailand. The contract starts on June 1, 2022 and is worth approximately USD $19.5M over a three-year period. Under the agreement, GFCS will service approximately 4,000 units across Thailand and provide full a full suite of ATM services, including replenishment, maintenance and cleaning services. "We are delighted to have extended this significant multi-year ATM contract with Government Savings Bank in Thailand. This contract is a further illustration of our competitiveness, reliability, and solid reputation in the industry," commented, Kee Yun Kwan, Chief Operating Officer at Guardforce AI. "The cash logistic market represents a significant growth opportunity for our cost-effective and secure cash management solutions. Based on a recent report from Allied Market Research, the global cash logistic market is projected to grow from $16.83 billion in 2020 to $33.28 billion by 2030. Additionally, with the easing of COVID-19 restrictions and the revival of the economy, especially tourism, we anticipate that the demand for our secured logistics solutions will continue to increase. We look forward to accelerating the commercial rollout of our cash solutions across Thailand, which play an important role in reducing risks and public exposure of cash transfer."
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THTX | Hot Stocks07:42 EDT Theratechnologies announces new Head of Investor Relations - Theratechnologies announced that Elif McDonald has joined the team as Senior Director, Investor Relations. McDonald brings experience earned over 20 years in capital markets, investor relations, financial communications, and corporate governance.
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HBI | Hot Stocks07:40 EDT Hanesbrands announces ransomware attack - In a regulatory filing, the company said, "On May 24, 2022, Hanesbrands identified that it had become subject to a ransomware attack and activated its incident response and business continuity plans designed to contain the incident. The company's forensic investigation and assessment of the impact of this event is ongoing. The company has notified appropriate law enforcement authorities and is cooperating with the investigation. Legal counsel, a cybersecurity forensic firm, and other incident response professionals have been engaged. As the company is in the early stages of its investigation and assessment of this event, the company cannot determine at this time whether or not such event will have a material impact on its business, operations or financial results."
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PYR | Hot Stocks07:39 EDT PyroGenesis announces completes another commercial order - PyroGenesis Canada announces that the Company has received, and completed, another commercial order for its plasma atomized titanium powders for 3D printing. "This latest order, for 100kg, represents the second consecutive commercial batch of metal powders produced using the Company's NexGen plasma atomization system, at our state-of-the-art production facility in Montreal, in as many weeks," said Massimo Dattilo, VP, PyroGenesis Additive. "We are excited to release this second 100kg batch so soon after the first. Creating the NexGen plasma atomization process, to produce the highest quality metal powders in the additive manufacturing industry, has been a long and exacting journey," continued Dattilo. "As mentioned in our previous press release, we are now producing larger commercial batches measuring in hundreds of kilograms, as opposed to sample batches measured in grams. The commercial milestones we have achieved over the previous few months have positioned us to move to the next step, which is to produce powders by the tonne."
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TGTX | Hot Stocks07:37 EDT TG Therapeutics announces FDA extension of BLA PDUFA date for ublituximab - TG Therapeutics announced that the U.S. Food and Drug Administration, FDA, has extended the Prescription Drug User Fee Act, PDUFA, goal date to December 28, 2022, for the Biologics License Application, BLA, for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis, RMS. The FDA extended the PDUFA goal date to allow time to review a submission provided by the Company in response to an FDA information request, which the FDA deemed a major amendment. The submission comprised an integration and summary of certain clinical information that was previously provided to the FDA by the Company. Michael Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, "While we are disappointed with the extension of our PDUFA goal date for ublituximab, a delay of this duration is not unprecedented, with both of the currently marketed CD20s in MS experiencing a similar 3-month PDUFA extension prior to approval. As we were targeting a launch for late this year or early next, we do not believe this will impact our overall launch plans for ublituximab in RMS." Mr. Weiss added, "We will continue to work with the FDA to complete the review of the ublituximab BLA and plan to be prepared and ready to launch upon approval. We believe ublituximab has the potential to offer RMS patients a valuable treatment option that can be administered in a one-hour infusion every six months following the first dose."
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LILM | Hot Stocks07:36 EDT Lilium achieves main wing transition - Lilium announced that its technology demonstrator Phoenix 2 has achieved main wing transition. This means it is the first ever full-size electric jet aircraft to transition from hover to wing-borne flight. "This is a landmark moment for Lilium and for electric aviation as a whole," the company said. Phoenix 2 has now achieved this milestone across the entire main wing while, most importantly, remaining stable and behaving as predicted by Lilium's proprietary Flight Dynamics Model. Matthias Meiner, Phoenix Chief Engineer and Lilium Co-Founder of Lilium said: "Main wing transition is a huge step forward on our path to launch and it validates our Flight Dynamics Model. Full credit goes to the outstanding Lilium team who worked so hard to get us here, and who remain laser-focused on the rest of the Flight Test Campaign.
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BIOT | Hot Stocks07:36 EDT Biotech and Blade announce postponement of extraordinary general meeting - Biotech Acquisition and Blade Therapeutics announced the postponement of BAC's extraordinary general meeting of shareholders originally scheduled to be held on June 1. The Extraordinary Meeting has been postponed until June 3 at 10:00 a.m. Eastern Time. As previously announced, the Extraordinary Meeting will occur at the offices of Ellenoff Grossman. The Extraordinary Meeting is being held to vote on the proposals described in BAC's definitive proxy statement, filed with the SEC on May 9 as supplemented by a Prospectus Supplement dated May 23 relating to the previously announced proposed business combination with Blade. The record date for the determination of shareholders entitled to vote at the Extraordinary Meeting, including all adjournments thereof, remains March 28. The BAC Board of Directors continues to recommend that shareholders vote in favor of the proposals. As of the date of this press release, a sufficient number of BAC's shareholders have voted to approve the proposed business combination. The postponement of the Extraordinary Meeting is intended to permit more time to satisfy all conditions necessary to effect the closing of the proposed Business Combination.
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MGDPF | Hot Stocks07:35 EDT Marathon Gold makes engineering, construction management appointments - Marathon Gold provides an update on project execution planning at the Valentine Gold Project located in central Newfoundland. Marathon announces that is has signed a Letter of Intent with SNC-Lavalin to complete detailed engineering for the Project's mill and major facilities, and develop related equipment and construction packages. SNC-Lavalin is a fully integrated professional services and project management company with offices around the world that has particular experience in the engineering and delivery of mineral processing projects. Marathon further announces the appointment of Progesys to partner with Marathon in the development of an integrated construction management team. Progesys will provide project management, facilities construction, and project control services. The Progesys-Marathon construction team will continue through to the operational readiness and commissioning phases of the Project until delivery to a Marathon operating team.
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LIND | Hot Stocks07:34 EDT Lindblad Expeditions names Noah Brodsky as Chief Commercial Officer - Lindblad Expeditions Holdings announced it has named Noah Brodsky as its Chief Commercial Officer, effective today. Brodsky has built a 20+ year career focused on inspirational travel experiences and premium guest service through a succession of sales, marketing and operating roles at leading global hospitality companies. He is a demonstrated leader in innovative marketing strategies, revenue growth and digital transformation. Most recently, Brodsky served as the President of the Travel + Leisure Group and Chief Brand Officer for Travel + Leisure, the world's leading membership and leisure travel company. During his tenure, he led the rebranding of the Company, substantially grew the rental division, and created and launched multiple branded products, including a full-service travel agency, a subscription travel club, and a licensed goods business.
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SGC | Hot Stocks07:34 EDT Superior Group appoints Koempel as CFO - Superior Group of Companies announces that the Board of Directors of the Company has appointed Michael Koempel to the role of Chief Financial Officer, CFO, of the Company, effective May 31, 2022. Most recently, Koempel was chief operating officer of IT'SUGAR. Koempel will report directly to SGC's Chief Executive Officer, Michael Benstock. Alongside the hiring of Koempel comes the announcement that Andrew Demott, Jr. will resign as Chief Financial Officer, effective May 31, 2022, but will remain with the Company as its Chief Operating Officer and as a Director. Demott intends to retire as an employee in 2023.
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ENIA | Hot Stocks07:33 EDT Enel Americas voluntarily delists American Depositary Shares from NYSE - Enel Americas announced that its Board of Directors has unanimously approved the voluntary delisting of its American Depositary Shares from The New York Stock Exchange, termination of its American Depositary Receipt facility and deregistration with the U.S. SEC upon satisfaction of the requirements for deregistration. In connection with its intended delisting, Enel Americas notified the NYSE that it will apply for voluntary delisting of its ADSs and has requested that the ADSs be suspended from trading on June 20. As a result, the last day of trading for the ADSs on the NYSE is expected to be on June 19. Following the merger transaction and related tender offer that occurred in April 2021, its parent company, Enel S.p.A., now owns 82.3% of the total outstanding shares of Enel Americas' common stock and Enel Americas ADSs as of April 30, comprise only approximately 2.49% of the total outstanding shares of common stock. Enel Americas believes that the costs associated with continuing the listing of its ADSs on the NYSE exceed the benefits received by the company, as the primary market for the shares of Enel Americas not owned by Enel S.p.A. is now the Santiago Stock Exchange. As a result, Enel Americas has decided to file an application for voluntary delisting from the NYSE as part of its effort to reduce operational expenses.
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BTX RMED | Hot Stocks07:32 EDT Brooklyn ImmunoTherapeutics announces changes to executive management - Brooklyn ImmunoTherapeutics (BTX) announced the appointment of Matt Angel, Ph.D., Co-Founder, Chairman, and CEO of Factor Bioscience Inc., as Interim Chief Executive Officer and President. He will replace Howard Federoff, M.D., Ph.D., Chief Executive Officer and President, who departs to focus on building a new venture. The Company also announces the appointment of Andrew Jackson as Chief Financial Officer. Dr. Angel is an experienced biotechnology entrepreneur and executive, having led Factor Bioscience as CEO since its founding in 2011. Jackson joins the Company from Ra Medical Systems (RMED), a medical device company focused on vascular diseases where he served as its Chief Financial Officer and Secretary and for a period, its Interim Chief Executive Officer.
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MITO | Hot Stocks07:26 EDT Stealth granted orphan drug designation for elamipretide by EMA - Stealth BioTherapeutics announced that the European Medicines Agency, or EMA, has granted orphan drug designation, or ODD, for elamipretide for the treatment of myopathic mitochondrial DNA depletion syndrome, M-MDS, a designation which applies to patients with nPMM eligible for enrollment in the NuPOWER Phase 3 clinical trial, which is currently enrolling patients at multiple clinical trial sites in the U.S. and Europe.
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SPTN | Hot Stocks07:21 EDT SpartanNash shareholder announces ISS recommendation for its proxy card - Macellum Advisors and Ancora Holdings, who beneficially own approximately 4.5% of the outstanding common shares of SpartanNash announced that Institutional Shareholder Services, or ISS, an independent proxy advisory firm, has recommended the company's shareholders vote for boardroom change on the blue proxy card. In particular, ISS recommends the addition of two of the investor group's nominees - Michael Lewis and John Fleming - to SpartanNash's board of directors. Jonathan Duskin, managing partner of Macellum, and Fredrick DiSanto, chairman and CEO of Ancora, commented: "We are pleased that ISS has endorsed our case for change at SpartanNash and recommended shareholders vote on the BLUE proxy card to elect two of our highly qualified, independent director candidates to the Company's nine-member Board. In our view, ISS' recommendation validates our thesis that the current Board lacks the operational knowhow, industry expertise and shareholder perspective required to unlock the Company's full potential. It is particularly notable that ISS affirmed our view that leadership's reactionary three-year plan includes targets that are meager and fall short of what shareholders deserve over the long run. Indeed, shareholders have already suffered through years of financial and operational underperformance."
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CROJF | Hot Stocks07:20 EDT Marimaca Copper announces progression of various ESG initiatives - Marimaca Copper announces the progression of various ESG initiatives in its commitment to integrate ESG best practice into development activities. Marimaca Copper has completed its first independent ESG performance assessment via the Digbee ESG reporting and assessment framework, to assist in its evaluation of ESG performance and current positioning. Hayden Locke, President and CEO of Marimaca Copper commented: "We see clear benefits in taking part in the Digbee ESG performance assessment as we have always understood the significant ESG opportunities provided to us as a Company and for the Marimaca project itself. This process will help us to refine our plans and thinking as we move towards development. We have already taken significant steps to adopting our new Sustainability Commitments, which we will use to take the project forward. We are also looking to provide a new basis for stakeholder engagement, one which focuses on dialogue at an early stage to address any issues as they may arise. We will be completing our second Digbee assessment in Q3/Q4 2022, by which time we expect to have made additional strides in the development of ESG-related areas, particularly with our plans for long-term sea water supply for operations and anticipated sourcing of power."
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ZEAL | Hot Stocks07:14 EDT Zealand Pharma announces multiple presentations at ADA Scientific Sessions - Zealand Pharma announced that three oral presentations and two poster abstracts with Zealand Pharma products have been accepted for the upcoming 82nd Scientific Sessions of the American Diabetes Association, ADA, which is being held in New Orleans from June 3-7, 2022. Zealand Pharma has two oral presentations, including Phase 1 clinical data demonstrating significant weight loss with Zealand's dapiglutide, a novel GLP1/GLP2 dual agonist and preclinical data on the antidiabetic potential of the company's long-acting amylin analogue ZP8396. Zealand also has a poster presentation with preclinical data highlighting the weight loss effects of ZP8396. Two additional abstracts include study results from a Zealand supported, investigator-initiated trial with dasiglucagon led by investigators from the Steno Diabetes Center. This oral presentation reports novel data on the use of low dose dasiglucagon for prevention and treatment of non-severe hypoglycemia in people with type 1 diabetes. Additionally, Boehringer Ingelheim will have a poster presentation with preclinical data on the dual glucagon and glucagon-like peptide-1 receptor agonist BI 456906 co-invented with Zealand Pharma, for the treatment of obesity.
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RVVTF | Hot Stocks07:13 EDT Revive Therapeutics advances inflammatory liver disorders programs - Revive Therapeutics announced that in light of the growing cases of acute hepatitis in children reported by the World Health Organization, WHO, the Company will advance its drug pipeline for inflammatory liver disorders including Bucillamine in the prevention of ischemia-reperfusion injury during liver transplantation and Cannabidiol for autoimmune hepatitis. As of May 26, 2022, six hundred and fifty probable cases of acute hepatitis of unknown aetiology in children have been reported to WHO from 33 countries in five WHO Regions between 5 April and 26 May 2022. Revive has entered into a clinical trial agreement with The Trustees of Indiana University to develop and manage a proposed Phase 2 clinical study using Cannabidiol as an adjunct therapy for difficult to treat autoimmune hepatitis. Revive will also explore the use of Bucillamine for liver transplantation with clinical investigators on the protocol design and regulatory pathway to obtain FDA acceptance to proceed with a clinical study under an investigational new drug application. The Company believes the use of Bucillamine during liver transplantation has the potential to be a safe and effective approach to address the unmet medical need for a novel strategy to limit or prevent ischemia-reperfusion injury.
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EQX | Hot Stocks07:12 EDT Equinox Gold receives approval for TSF raise at RDM Mine in Brazil - Equinox Gold announces that further to its press release dated May 16 approval for the tailings storage facility, or TSF, raise at its RDM Mine in Brazil has been received. The TSF raise contractor is mobilizing equipment to begin the raise in early June. Equinox Gold expects that full operations will resume by mid-July. Equinox Gold will update RDM guidance with its Q2 disclosures in the first week of August.
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FLGC AMZN | Hot Stocks07:12 EDT Flora Growth subsidiary launches JustCBD on Amazon - Flora Growth (FLGC) announced that its wholly-owned subsidiary JustCBD will be launching its line of Novel Foods registered CBD products on Amazon.co.uk. Amazon UK (AMZN) entered the now GBP 700M CBD market in October 2021 and has since expanded the initial pilot-only program to include vendors who have demonstrated their compliance with the UK CBD Novel Food regulations. Producers awarded with UK Novel Food authorization must prove the product is safe for consumption and labeled correctly.
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HAS | Hot Stocks07:10 EDT Hasbro board issues letter to shareholders ahead of June 8 meeting - Hasbro issued the following letter to Hasbro shareholders in connection with the Company's 2022 annual meeting of shareholders to be held on June 8. "As we approach the last few days leading up to Hasbro's Annual Meeting of Shareholders, taking place June 8 we ask you to vote the WHITE proxy card and "FOR ALL" the nominees proposed by the Hasbro Board... With our newly appointed CEO, Chris Cocks, we are charting Hasbro's next chapter of growth and success. Chris, together with Liz Hamren and Blake Jorgensen - each of whom have joined the Board in the last couple of months - bring depth of expertise, talent and informed points of view about our business. They have been change agents with a track record of delivering value. Their new perspective, combined with the depth of experience of our other board members, provide the right combination of skills and experience, and also stability and context, to position Hasbro to deliver long-term value and returns for our shareholders."
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ZNTL | Hot Stocks07:10 EDT Zentalis promotes cofounder Cam Gallagher to President - Zentalis Pharmaceuticals announced the promotion of Cofounder Cam Gallagher, MBA, to President. Gallagher, who previously served as an Executive Director of Zentalis, will remain a member of the Board of Directors, which he has served on since the Company's founding. He will report to Chief Executive Officer Dr. Kimberly Blackwell.
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PYPD | Hot Stocks07:09 EDT PolyPid announces completion of enrollment in Phase 3 SHIELD I trial - PolyPid announced the completion of enrollment in the SHIELD I Phase 3 study of D-PLEX100 for the prevention of surgical site infections, SSIs, in abdominal surgery. Following a review of unblinded efficacy data from the first 750 enrolled patients in the trial, the independent Data Safety Monitoring Board, DSMB, recently recommended concluding the study upon enrollment of 950 patients, which is the minimum number of targeted patients in the trial protocol. "The conclusion of enrollment in the pivotal SHIELD I trial, the largest colorectal surgery clinical study conducted in more than a decade, represents an important milestone for our D-PLEX100 development program and our company as a whole," stated Amir Weisberg, PolyPid's Chief Executive Officer. "We look forward to the availability of top-line results from SHIELD I by the end of the third quarter of 2022. Subsequent to these expected data, we intend to pursue a pre-NDA meeting with the FDA to discuss a rolling NDA submission, consistent with the Breakthrough Therapy Designation previously granted, with potential NDA and MAA submissions planned for the first half of 2023. We are also focused on further advancing commercial pre-launch activities, while expediting partnership discussions in and outside of the United States."
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SII | Hot Stocks07:08 EDT Sprott announces CEO transition - Sprott announced that its board of directors has named Whitney George as Chief Executive Officer of Sprott, effective June 30, 2022. George, currently the Company's President, will take over from Peter Grosskopf, who will focus full time on his roles as Chief Executive Officer of Sprott Capital Partners and as an advisor to Sprott's private resource strategies. Concurrent with the transition, Grosskopf will resign from the Sprott board of directors and George will be appointed to the board on June 30, 2022. Whitney George joined Sprott in 2015 serving in a number of roles, including as Chief Investment Officer of Sprott Asset Management since 2018 and as President of Sprott since 2019.
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TELA | Hot Stocks07:07 EDT Tela Bio secures up to $50M in debt financing from MidCap Financial - TELA Bio announced that the Company has entered into a new credit facility with MidCap Financial, providing TELA with access to up to $50M in total credit. A portion of the proceeds from the new credit facility were used to fully repay TELA's existing $30M credit facility with OrbiMed Royalty Opportunities II, LP, with the remaining proceeds under the credit facility available for working capital needs and other corporate purposes. "We are excited about our new partnership with MidCap which provides TELA with cost-effective funding and financial flexibility. This transaction is reflective of TELA's strong financial condition and prospects, which enabled us to access the debt capital markets to obtain non-dilutive financing," said Antony Koblish, president and CEO of TELA Bio. "The proceeds from this loan will allow TELA to fund its current key business objectives and drive future growth initiatives, with minimal further capital required to be raised, if at all."
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EQX | Hot Stocks07:07 EDT Equinox completes exploration of western drill targets of Imperial Gold Project - KORE Mining announced completion of the 2021-2022 winter exploration field season and provides a summary of the western drill targets of the Imperial Gold Project. This release summarizes the geologic context for the five western targets: Ogilby, Powerline Discovery Outcrop, Ironwood, Smoketree, and East Mesquite,which are in the western exploration target area between the Imperial deposit and the Mesquite gold mine. The western target areas include five targets covering over 2,400 acres across 8.3 kilometers of strike length. There are a total of nine drill target areas identified in the overall Mesquite-Imperial-Picacho District that captures a 28 kilometers trend. KORE's Executive Chairman, James Hynes, commented, "KORE had a great field season on the Mesquite-Imperial-Picacho trend. While the area is still not fully covered with field mapping and sampling, KORE field tested all satellite alteration and historic known gold anomalies and outcrops aligned with the regional geophysical trend from the Mesquite mine through Imperial towards the closed Picacho mine. We have a large number of drill targets in inventory and must now prioritize for additional drill permit applications ." In Ogilby Target Area Ground resistivity and induced polarization surveys provide strong evidence that the primary mineralizing structure at the Imperial deposit is continuous across the 3 km of strike length to the Ogilby target area. This data indicates two anomalous trends which completed reconnaissance scale mapping and sampling in February. Assay results have confirmed the presence of gold near the surface trace of these anomalies, including highlights of 1.4 g/t gold and 0.8 g/t Au stream sediment samples. To date, a total of 19 strongly anomalous samples have been collected along the 2 km strike length of this WNW-ESE structural corridor.
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AMOT | Hot Stocks07:06 EDT Allied Motion acquires FPH Group, terms of were not disclosed - Allied Motion Technologies announced that it has acquired FPH Group an industry participant in developing technically advanced, reliable and cost-effective electrical drive systems and light weighting technologies for existing and future ground-based vehicles in the defense industry. "This acquisition is an excellent strategic fit as it provides us with a deeper penetration within defense applications including the necessary manufacturing licenses and certifications, which is a key end market focus for Allied. FPH has a proven relationship with leading defense prime contractors, which we believe we can leverage for future modernization designs as we combine Allied's scale and defense solutions with FPH's knowledge base of electrical, mechanical, fluid dynamics and composite technologies," commented Dick Warzala, Chairman and CEO. "In addition, FPH is expected to be accretive to both Allied's margin profile and earnings per share in the first year. We are very excited about our potential together and we welcome the entire, very capable FPH team to the Allied family." Barry Gilmour, Chairman of FPH, stated, "Joining forces with Allied will enhance our ability to advance our core competencies in support of our existing customers and provide a platform to further scale the business. Equally important is that our companies share similar cultures, and we look forward to a bright future together." Financial terms of the transaction were not disclosed.
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GUROF | Hot Stocks07:06 EDT GURU Organic Energy partners with The Amazing Race Canada - GURU Organic Energy announceds that it has partnered with CTV's THE AMAZING RACE CANADA as a sponsor. Showcasing unique activations for the racers throughout the season and offering the winners a once-in-a-lifetime trip for two around the world, GURU will also be running a contest online and in store allowing Canadians to get in on the action and win their own unforgettable trip to anywhere in the world, for a value of up to $10,000.
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TCRX | Hot Stocks07:05 EDT TScan Therapeutics announces FDA clearance of IND application for TSC-101 - TScan Therapeutic announced that the U.S. Food and Drug Administration, FDA, has cleared its investigational new drug, IND, application to evaluate TSC-101 for the treatment of patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation, HCT. The target of TSC-101 is the minor histocompatibility antigen HA-2, which is a lineage-specific antigen expressed on blood cells. TScan believes that TSC-101 is the first clinical program to target the HA-2 antigen. As previously announced, TScan's IND for TSC-100, which targets the minor histocompatibility antigen HA-1, was cleared by the FDA in January 2022. TSC-100 and TSC-101 are designed to address different subsets of patients undergoing allogeneic HCT. "This marks TScan's second IND clearance in our leukemia program. Our TCRs against both HA-1 and HA-2 antigens are aimed at reducing the risk of relapse following HCT, thereby enabling increased use of more tolerable conditioning regimens to allow more leukemia patients to be cured by transplantation," said David Southwell, President and Chief Executive Officer. "With the FDA clearance of TSC-101, we will now proceed with all components of our planned multi-arm Phase 1 clinical trial, with preliminary data from all three arms of the trial expected by the end of 2022."
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BABYF | Hot Stocks07:03 EDT Else Nutrition complete second preclinical study for Plant-Based infant formula - ELSE NUTRITION announces that it has concluded a second successful preclinical study on its Plant-Based infant formula, which is a crucial phase for bringing the Company's innovative 0-12 month infant formula to market. The study's results showed proper protein efficiency in a preclinical model; a significant step on the path with the Food and Drug Administration and other regulatory authorities to demonstrate the protein bioavailability of Else's infant formula. "This is a big step forward for the Company," said Hamutal Yitzhak, CEO & Co-Founder of Else Nutrition. "Since inception, our vision has been to fill the major market gap for an alternative to dairy and bring a whole-food, plant-based, soy-free infant formula to millions of families worldwide. These results mark further validation of our formulation, as we continue to push ahead in seeking FDA approval."
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AXSM | Hot Stocks07:03 EDT Axsome Therapeutics announces publication of results of Phase 3 trial of AXS-05 - Axsome Therapeutics announced the publication on May 30 of the results from the pivotal GEMINI Phase 3 clinical trial of AXS-05 in major depressive disorder. AXS-05 is a novel, oral, investigational N-methyl-D-aspartate receptor antagonist with multimodal activity. The article, "Efficacy and Safety of AXS-05 (dextromethorphan-bupropion) in Patients with Major Depressive Disorder: A Phase 3 Randomized Clinical Trial," was published in The Journal of Clinical Psychiatry. "The results published in The Journal of Clinical Psychiatry are consistent with strong and rapid antidepressant effects, and with a favorable safety profile with AXS-05," said Maurizio Fava, MD, Psychiatrist-In-Chief, Department of Psychiatry, Massachusetts General Hospital, Executive Director, Clinical Trials Network & Institute, Associate Dean for Clinical & Translational Research, Slater Family Professor of Psychiatry, Harvard Medical School, and co-author of the publication. "Depression is a difficult-to-treat condition with potentially devastating consequences for patients and their families. Based on these results and its novel oral NMDA antagonist mechanism, AXS-05 may represent an important new treatment option for patients with depression." "We are very pleased with the publication of the pivotal GEMINI trial results in The Journal of Clinical Psychiatry, a leading scientific journal, less than two weeks after the publication of the pivotal ASCEND trial results in The American Journal of Psychiatry," said Herriot Tabuteau, MD, CEO of Axsome. "These studies demonstrate a consistent efficacy profile for AXS-05 and form the basis of our NDA for the treatment of depression. If approved, we look forward to making AXS-05 available to Americans suffering from depression as soon as possible."
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PEI | Hot Stocks06:58 EDT Pennsylvania REIT executes purchase and sale agreement, expects $32M in proceeds - Pennsylvania REIT announced execution of a purchase and sale agreement for 11 outparcels that will generate gross proceeds in excess of $32M. The company also executed an agreement of sale for a vacant parcel at Springfield Town Center set to be developed into a hotel site for $2.5M as the company executes on its vision of delivering one-stop destinations for the communities it serves. These transactions represent a portion of the asset sale pipeline referenced in conjunction with the company's first quarter earnings release dated May 5 with $275M of transactions in process.
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RYAM | Hot Stocks06:57 EDT Rayonier Advanced Materials names De Lyle Bloomquist as CEO - Rayonier Advanced Materials announced that De Lyle Bloomquist has been appointed President and CEO of the company, effective immediately. Bloomquist succeeds Vito Consiglio, who has stepped down as President and CEO of the company, and as a member of the company's Board of Directors, with the mutual agreement of the Board. In connection with Bloomquist's appointment, the Board named Lisa Palumbo as Non-Executive Chair of the Board. Bloomquist most recently served as a partner at Windrunner Management Advisors LLC, a management advisory services business, and prior to that served as the President, Global Chemical Business of Tata Chemicals Limited, and President, CEO and Director of Tata Chemicals North America.
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TRN | Hot Stocks06:56 EDT Trinity Industries to acquire Quasar Platform from Cando Rail & Terminals - Trinity Industries announced the acquisition of Quasar Platform from Cando Rail & Terminals. Quasar is an end-to-end rail logistics software platform providing a real-time data universe to freight rail shippers and operators. The acquisition enhances Trinity's digital product portfolio, including Trinsight(TM), by adding additional capabilities like yard management, activity-based costing, and new data visualization tools. The acquisition closed on May 26 and is not expected to be material to Trinity's results. Trinity will retain all of the employees of Quasar as part of the transaction. PricewaterhouseCoopers Corporate Finance was the exclusive financial advisor to Quasar.
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APTS | Hot Stocks06:47 EDT Glass, Lewis & Co. recommends Preferred Apartment's stockholders to vote "FOR" - Preferred Apartment Communities announced that Glass, Lewis & Co., another leading independent proxy advisory firm, has joined Institutional Shareholder Services, or ISS, in recommending that stockholders vote "FOR" the previously announced all-cash acquisition of PAC by Blackstone Real Estate Income Trust, or BREIT, at PAC's upcoming Special Meeting of Stockholders scheduled for June 7 at 9:00 a.m., Eastern Time. As previously announced, PAC and affiliates of BREIT have entered into a definitive merger agreement pursuant to which BREIT has agreed to acquire PAC for $25.00 per share of common stock. The proposed acquisition is expected to be completed on or about June 9, subject to approval by PAC's common stockholders and the satisfaction or waiver of other customary closing conditions. PAC's Board of Directors recommends that you vote "FOR" the proposed acquisition of PAC by BREIT. All PAC stockholders of record as of the close of business on April 11, 2022 are entitled to vote.
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HTH | Hot Stocks06:45 EDT Hilltop Holdings announces preliminary results of tender offer - Hilltop Holdings announced the preliminary results of its modified "Dutch auction" tender offer to purchase up to $400M of its common stock for cash at a price per share not less than $28.00 and not greater than $32.00, which expired at 12:00 midnight, New York City time, at the end of the day on May 27. Based on the preliminary count by American Stock Transfer & Trust Company, the depositary for the tender offer, a total of 14,876,179 shares of Hilltop's common stock, 1c par value per share, were properly tendered and not properly withdrawn at or below the purchase price of $29.75 per share, including 5,332,758 shares that were tendered by notice of guaranteed delivery. The number of shares conditionally tendered was 13,103 based on the preliminary count by the depositary. In accordance with the terms and conditions of the tender offer, and based on the preliminary count by the depositary, the Company expects to acquire approximately 14,876,179 shares of its common stock at a price of $29.75 per share, for an aggregate cost of approximately $442,566,325, excluding fees and expenses relating to the tender offer. Included in the 14,876,179 shares that the Company expects to accept for purchase, which represent approximately 18.7% of the shares outstanding, are 1,430,801 shares that the Company expects, subject to an additional non-objection from its regulators, to purchase pursuant to its right to purchase up to an additional 2% of its outstanding shares. As the Company expects to accept for purchase all the Shares that were properly tendered at a price at or below $29.75 and not properly withdrawn, the Company expects there to be no proration factor.
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RHHBY | Hot Stocks06:41 EDT FDA approves Roche's Evrysdi for use in babies under two months with SMA - Roche announced that the U.S. Food and Drug Administration has approved a label extension for Evrysdi to include babies under two months old with spinal muscular atrophy, or SMA. The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment. Evrysdi is now approved in the U.S. to treat SMA in children and adults of all ages. As part of the label extension, the Evrysdi prescribing information has also been updated to include recent two-year pooled data from Parts 1 and 2 of the FIREFISH study, which demonstrate long-term efficacy and safety in symptomatic infants with Type 1 SMA. The study enrolled babies aged 1-7 months and after two years of treatment with Evrysdi at the recommended dose, 60% of infants were able to sit without support* for five seconds, 40% for 30 seconds and 28% of infants were able to stand, the company noted.
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GSK... | Hot Stocks06:38 EDT ViiV Healthcare announces marketing approval in Japan for Vocabria combo - ViiV Healthcare, the global specialist HIV company majority-owned by GSK (GSK) with Pfizer (PFE) and Shionogi (SGIOY) as shareholders, announced it obtained approval for Vocabria used in combination with Janssen Pharmaceutical Companies of Johnson & Johnson's (JNJ) Rekambys and Edurant, which it calls "the first and only complete long-acting treatment for HIV," from the Ministry of Health, Labour and Welfare in Japan. Cabotegravir injection used in combination with rilpivirine long-acting is indicated to treat human immunodeficiency virus type 1 infection in adults who are virologically suppressed, on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
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AXNX | Hot Stocks06:11 EDT Axonics files premarket approval supplement with FDA for its sacral INS - Axonics has filed a premarket approval supplement with the FDA for its fourth generation rechargeable sacral neuromodulation implantable neurostimulator, or INS. The fourth generation rechargeable INS reduces how frequently a patient needs to recharge their implanted device to only once every six months for one hour. This compares to the current recharging interval of once a month for one hour with the Axonics third generation rechargeable INS. The new INS utilizes the same small 5cc form factor as the Axonics R15 and is paired with the same tined lead and intuitive, easy to use patient remote control. Axonics expects the new INS to receive FDA labeling for 20 years of useful life in the body. Axonics anticipates receiving FDA approval for the fourth generation rechargeable INS in the Q4 and expects to begin shipping the new device to customers in the Q1 of 2023. This filing follows the recent FDA approval of the Axonics F15, the company's newly developed, long-lived, recharge-free system, which commenced a comprehensive U.S. commercial launch in April.
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TXMD | Hot Stocks06:08 EDT TherapeuticsMD signs definitive agreement to be accquired by affiliate of EW - TherapeuticsMD announced that it has entered into a definitive merger agreement to be acquired by an affiliate of EW Healthcare Partners, a private equity firm dedicated to making investments in rapidly growing healthcare companies. Under the terms of the transaction EW Healthcare Partners will commence a tender offer to acquire all outstanding shares of TXMD common stock for $10.00 per share in an all-cash transaction, followed immediately by a merger. The purchase price represents a premium of 367.3% over TherapeuticsMD's closing share price on May 27. The transaction, which has been unanimously approved by TherapeuticsMD's Board of Directors, implies a total enterprise value for the Company of approximately $177M and will be structured as an all-cash tender offer to acquire all issued and outstanding shares of TherapeuticsMD common stock, followed immediately by a merger. In connection with entering into the transaction, the lenders and administrative agent under the Company's Financing Agreement with Sixth Street Partners have agreed to extend the maturity date of the Financing Agreement to July 13, allowing the Company to complete the transaction with EW Healthcare Partners on or before that date. In addition, the lenders and administrative agent have agreed to roll-over the Company's indebtedness under the Financing Agreement in connection with, and conditioned on, the closing of the merger. Closing of the tender offer and merger are subject to certain conditions, including that a majority of the shares of TherapeuticsMD's common stock are tendered and not withdrawn in the tender offer, that there is no default or event of default under the Company's Financing Agreement, and other customary closing conditions. Greenhill & Co. is serving as financial advisor and DLA Piper LLP (US) is serving as legal counsel to TherapeuticsMD. EW Healthcare Partners was advised by Kirkland & Ellis, PwC, and BCG.
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CODA | Hot Stocks06:08 EDT Coda Octopus CFO Mike Midgley to retire, Nathan Parker to succeed - Coda Octopus Group announced the retirement of its current CFO, Mike Midgley who will formally leave his post in June 2022 and the appointment of Nathan Parker who will succeed Midgley as CFO, effective June 13. Parker will be based in Salt Lake City. Nathan Parker joins the Group as a well-qualified and experienced financial professional who will bring a number of additional skills to this role. From 2021 to 2022, Nathan was CFO for the Water Treatment business of Franklin Electric, a Fort Wayne Indiana based $2B global leading manufacturer and distributor of water and fuel systems for use across residential, commercial, agricultural, industrial, and municipal applications.
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ALLE DE | Hot Stocks06:06 EDT Allegion CEO David Petratis to retire, John Stone to succeed - Allegion (ALLE) announced that John Stone will succeed David Petratis as president and CEO, effective July 11. Stone will also become a member of the company's Board of Directors at that time, and Petratis will serve as executive chairman until his retirement, which is expected by Jan. 2, 2023. Stone brings to Allegion more than 18 years of senior leadership experience. Most recently, he served as president of Deere & Company's (DE) Worldwide Construction, Forestry and Power Systems business, overseeing the nearly $11.4B segment.
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PCH CTT | Hot Stocks06:03 EDT PotlatchDeltic, CatchMark Timber to combine in an all-stock transaction - PotlatchDeltic (PCH) and CatchMark Timber Trust (CTT) announced that they have entered into a definitive agreement to combine in an all-stock transaction. The acquisition by PotlatchDeltic will strengthen and diversify a leading integrated timber REIT and continue to enhance shareholder value. Based on the closing stock prices of PotlatchDeltic and CatchMark on May 27, 2022, the combined company is expected to have a pro forma market capitalization over $4B and total enterprise value of more than $5B, including $557M in net debt. Under the terms of the agreement, which has been unanimously approved by the Board of Directors of both companies, CatchMark stockholders will receive 0.23 common shares of PotlatchDeltic stock for each common share of CatchMark that they own. This reflects a price per share of $12.88 for each common share of CatchMark, and a 55% premium to CatchMark's common share price as of the close of business on May 27, 2022. Following close of the transaction, PotlatchDeltic stockholders will own approximately 86% of the combined company, and CatchMark stockholders will own approximately 14% on a fully diluted basis. The combination brings together two high quality timberland REITs resulting in PotlatchDeltic owning approximately 2.2M acres of diversified timberlands including 626,000 acres in Idaho and over 1.5M acres in strengthening markets in the U.S. South. PotlatchDeltic also remains the timber REIT with the most leverage to lumber prices, including 1.1B board feet of lumber capacity. The transaction also combines two successful and complementary real estate businesses. The Board of Directors of the combined company will consist of nine Directors from PotlatchDeltic and one Director from CatchMark. The corporate headquarters will be maintained in Spokane, Washington. A regional office will be maintained in Atlanta, Georgia. The transaction is expected to close in the second half of 2022. The transaction requires approval of stockholders of CatchMark and is subject to the satisfaction of customary closing conditions and regulatory approvals. Due to the transaction, CatchMark has postponed the 2022 annual meeting of its stockholders that had been scheduled for June 14.
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ELDN | Hot Stocks06:02 EDT Eledon announces results from Phase 2a clinical trial of tegoprubart - Eledon Pharmaceuticals announced topline results from a Phase 2a clinical trial of tegoprubart, formerly AT-1501, in patients with amyotrophic lateral sclerosis, or ALS. Tegoprubart is an investigational humanized monoclonal antibody that inhibits CD40 Ligand, or CD40L, a membrane protein linked to increased peripheral immune responses and neuroinflammation in ALS. The 12-week trial included 54 patients with ALS at 13 treatment sites in the United States and Canada. The primary objectives of the study were to assess the safety and tolerability of multiple doses of tegoprubart in four sequential, ascending dose cohorts. Secondary outcome measures included pharmacokinetic assessment of multiple intravenous doses of tegoprubart on target engagement and on pro-inflammatory biomarkers associated with ALS. Each subject served as their own control, with changes being compared to baseline. Tegoprubart successfully met the primary endpoints of safety and tolerability. Adverse events were equally distributed across dose levels. Tegoprubart was well-tolerated, and no drug-related serious adverse events were observed. Anti-drug antibodies, or ADAs, were present in less than 5 percent of samples. All ADAs were of low titer and did not impact tegoprubart drug levels.
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PCH CTT | Hot Stocks06:01 EDT PotlatchDeltic, CatchMark Timber to combine in an all-stock transaction
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GSK | Hot Stocks05:50 EDT GlaxoSmithKline reaffirms FY22 guidance, medium-term outlook - New GSK reaffirms its full-year 2022 guidance and the medium-term outlook for 2021-2026 of more than 5% sales and 10% adjusted operating profit CAGR at CER.
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GSK | Hot Stocks05:49 EDT GlaxoSmithKline to buy Affinivax in potential $3B deal - GSK announced that it has entered into a definitive agreement to acquire Affinivax, a clinical-stage biopharmaceutical company based in Cambridge, Boston, Massachusetts, for a $2.1B upfront payment and up to $1.2B in potential development milestones. Affinivax is developing a novel class of vaccines, the most advanced of which are next-generation pneumococcal vaccines, GSK said in a statement. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "The proposed acquisition further strengthens our vaccines R&D pipeline, provides access to a new, potentially disruptive technology, and broadens GSK's existing scientific footprint in the Boston area. We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialization capabilities to make this exciting new technology available to those in need." Under the terms of the agreement, GSK will acquire 100% of the outstanding shares of Affinivax. The consideration for the acquisition comprises an upfront payment of $2.1B to be paid upon closing and two potential milestone payments of $0.6B to be paid upon the achievement of certain paediatric clinical development milestones. The transaction is subject to customary closing conditions, including the expiration or early termination of the waiting period under the Hart-Scott- Rodino Anti-Trust Improvements Act of 1976. The transaction is expected to close in the third quarter of 2022.
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REGN | Hot Stocks05:27 EDT Regeneron, Sanofi announce Dupixent sBLA accepted for priority review - Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the supplemental biologics license application, or sBLA, for Dupixent Medical to treat adults with prurigo nodularis, a chronic skin disease that causes extreme itch and inflammatory skin lesions. The target action date for the FDA decision is September 30.
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ARGX | Hot Stocks05:24 EDT Argenx announces efgartigimod awarded scientific opinion by the MHRA - Argenx announced that efgartigimod, the company's neonatal Fc receptor, or FcRn, blocker has been awarded a scientific opinion by the MHRA under the EAMS. Within the EAMS, efgartigimod is indicated for the treatment of adult patients with anti-acetylcholine receptor, or AChR, antibody seropositive gMG, including patients with refractory gMG who have failed, not tolerated or are ineligible for licensed treatment. The European Medicines Agency is currently reviewing the MAA for efgartigimod for the treatment of gMG, with a decision expected in the second half of 2022, followed by an anticipated decision from the MHRA on a UK marketing authorization. Efgartigimod was previously granted a PIM designation by the MHRA in November 2021.
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PTCT | Hot Stocks05:22 EDT PTC Therapeutics announces FDA approval for Evrysdi label extension - PTC Therapeutics announced that the FDA has approved a label extension for Evrysdi to include infants under two months old with spinal muscular atrophy, or SMA.
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GFI AUY | Hot Stocks05:20 EDT Gold Fields to acquire Yamana Gold in $6.7B transaction - Gold Fields (GFI) and Yamana Gold (AUY), announced that they have entered into a definitive agreement, under which Gold Fields will acquire all of the outstanding common shares of Yamana pursuant to a plan of arrangement. Under the terms of the transaction, all of the outstanding Yamana Shares will be exchanged at a ratio of 0.6 of an ordinary share in Gold Fields or 0.6 of a Gold Fields American depositary share for each Yamana share. The transaction implies a valuation for Yamana of $6.7B and represents a premium of 33.8% to the 10-day Volume-Weighted Average Price, or VWAP, of Yamana's Shares of $5.201 on Friday, May 27, being the last trading day on the NYSE prior to the date of this announcement, based on the 10-day VWAP of Gold Fields ADSs of $11.592. Upon closing of the transaction, it is anticipated that Gold Fields shareholders and Yamana shareholders will own approximately 61% and 39% of the combined group, respectively. The combined group will maintain its presence in all regions while continuing to honor commitments to stakeholders. The transaction has been unanimously approved by the board of directors of both Gold Fields and Yamana and is expected to close in the second half of 2022 subject to and following the satisfaction of the conditions precedent to the transaction. Gold Fields will remain headquartered in Johannesburg. The acquisition will be implemented by way of a plan of arrangement of Yamana under the Canada Business Corporations Act, or CBCA, pursuant to the arrangement agreement entered into between Gold Fields and Yamana. The consideration payable to the shareholders of Yamana will consist of either, at the election of a Yamana shareholder, newly issued Gold Fields shares or newly issued Gold Fields ADSs, which each represent one Gold Fields Share, in accordance with the exchange ratio. The Gold Fields shares are listed on the Johannesburg Stock Exchange and the Gold Fields ADSs are listed on the NYSE. The board of directors of Gold Fields has unanimously approved the arrangement agreement. The board of directors of Gold Fields recommends that Gold Fields Shareholders vote in favor of the transaction. After consultation with its outside financial and legal advisors, the Board of Directors of Yamana has unanimously approved the Arrangement Agreement. The Board of Directors of Yamana recommends that Yamana Shareholders vote in favour of the Transaction. In addition, all of the Directors and Senior Officers of Yamana, have entered into binding voting support agreements with Gold Fields under which such individuals have agreed to support and vote their Yamana Shares in favour of the Transaction. The Board of Directors of Yamana has received fairness opinions from Canaccord Genuity Corp. and Scotiabank that, as of the date of each such opinion, and based upon and subject to the assumptions, limitations and qualifications stated in each such opinion, the Transaction Consideration to be received by Yamana Shareholders is fair from a financial point of view to Yamana Shareholders. The Transaction will be effected by way of a plan of arrangement under the CBCA, pursuant to which all of the Yamana Shares will be acquired by a wholly-owned indirect subsidiary of Gold Fields in exchange for the Transaction Consideration to be settled by Gold Fields in the form of the Gold Fields Consideration Shares. Pursuant to the terms of the Transaction, the consideration payable to the Yamana Shareholders at closing of the Transaction will consist of: either newly issued Gold Fields Shares; or at the election of Yamana Shareholders, newly issued Gold Fields ADSs, which each represent one Gold Fields Share together the "Gold Fields Consideration Shares"), in accordance with the Exchange Ratio. The Transaction will require the approval of at least 66 2/3% of the votes cast by Yamana Shareholders voting in person or represented by proxy at a special meeting of Yamana Shareholders called for that purpose. The issuance of Gold Fields Consideration Shares under the Transaction is also subject to the approval of at least 75% of the voting rights exercised on such resolution by Gold Fields Shareholders at a special meeting of Gold Fields shareholders called to approve the Transaction. The Transaction is subject to, among other things, the approval by the Ontario Superior Court of Justice (Commercial List), applicable stock exchange approvals and other regulatory approvals. The Arrangement Agreement includes reciprocal non-solicitation provisions (subject to provisions allowing the Board of Directors of each of Gold Fields or Yamana to exercise their fiduciary duties to change their recommendation and/or to enter into a permitted acquisition agreement in certain circumstances), and rights to match superior proposals. In addition, the Arrangement Agreement provides that, under certain circumstances, Gold Fields would be entitled to a US$300m termination fee and Yamana would be entitled to a US$450m termination fee. Senior officers and directors of each of Yamana and Gold Fields have entered into voting support agreements with Gold Fields and Yamana, respectively, agreeing to vote their Yamana Shares and Gold Fields Shares, respectively, in favour of the Transaction It is anticipated that both the Yamana and Gold Fields shareholder meetings will take place, and closing and completion of the transaction is expected to occur, in the second half of 2022, subject to satisfaction of the conditions under the arrangement agreement. Following the completion of the Transaction, the Gold Fields Shares will continue to trade on the JSE and the Gold Fields ADSs will continue to be listed on the NYSE, and the Yamana Shares will be delisted from each of the Toronto Stock Exchange, NYSE and London Stock Exchange.
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KW | Hot Stocks05:10 EDT Kennedy Wilson acquires portfolio of 20 UK urban logistics assets for $287M - Kennedy Wilson has acquired a portfolio of 20 UK urban logistics assets totaling 1.3M square feet, via an off-market transaction with UK logistics specialist, Leftfield, for $287M. Kennedy Wilson has a 20% ownership in the portfolio and invested $24M of equity in the transaction. The industrial properties are situated in urban logistics locations across the UK, including London and the South East, Yorkshire and the Midlands. The portfolio is 100% occupied.
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UL | Hot Stocks05:09 EDT Unilever names Nelson Peltz non-executive director, shares rally 7% - Unilever announced the appointment of Nelson Peltz as a non-executive director of the company and as a member of its Compensation Committee. It is expected that the appointments will be effective from July 20. Nils Andersen, Chair of Unilever, said: "We are pleased to be welcoming Nelson to the Unilever Board. We have held extensive and constructive discussions with him and the Trian team and believe that Nelson's experience in the global consumer goods industry will be of value to Unilever as we continue to drive the performance of our business. We look forward to working closely together to create long term sustainable value for our shareholders and wider stakeholders." Peltz's Trian Fund Management has confirmed that it manages funds which hold interests in approximately 37.4M ordinary shares of Unilever, constituting approximately 1.5% of Unilever's share capital, the company noted. Shares of Unilever are up 7% to $47.08 following the news.
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MRNA TAK | Hot Stocks05:07 EDT Moderna, Takeda announce plan to transfer Spikevax authorization in Japan - Moderna (MRNA) and Takeda (TAK) announced plans to transfer the marketing authorization in Japan for Moderna's COVID-19 vaccine Spikevax from Takeda to Moderna in Japan as of August 1. Moderna will assume responsibility for all Spikevax activities, including import, local regulatory, development, quality assurance and commercialization. Takeda will continue to provide distribution support under the current national vaccination campaign for Moderna COVID-19 vaccines for a transitional period. Both companies will be responsible for ensuring proper implementation of operations associated with this transfer.
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