Stockwinners Market Radar for June 28, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
CP... | Hot Stocks20:28 EDT Canadian Pacific says some North American unions oppose CN's use of voting trust - Canadian Pacific Railway Limited (CP) announced that unions representing railroad employees across the U.S., including SMART-Transportation Division General Committee GCA-457 representing Kansas City Southern (KSU) employees, have written letters urging the Surface Transportation Board to reject Canadian National's (CNI) proposed use of a voting trust. "If the CN voting trust and proposed merger were granted approval, we fully expect significant job losses on KCS because ultimately the transaction would require either a sale or abandonment of duplicative rail lines. The consequences for SMART-TD members would be uncertain, adverse, and certainly contrary to the public interest." -- Sam Habjan, General Chairperson of SMART-Transportation Division General Committee GCA-457, representing approximately 675 trainpersons on the KCS.
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CP... | Hot Stocks20:26 EDT Canadian Pacific says Amtrak files STB to oppose CN's use of voting trust - Canadian Pacific Railway (CP) announced that Amtrak, operator of intercity passenger rail service across the United States, has submitted comments urging the Surface Transportation Board to reject Canadian National's (CNI) use of a voting trust in its proposed combination with Kansas City Southern (KSU). In its filing made today, Amtrak said CN's proposed divestiture of the Baton Rouge to New Orleans line "creates a major new impediment to giving the 2.2 million residents along the New Orleans-to-Baton Rouge corridor the Amtrak service they deserve and have long needed." Amtrak also said, "CN's 'divestiture' proposal is the equivalent of a homeowner selling their house but reserving the right to continue to live in it."
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ACI | Hot Stocks20:19 EDT Albertsons supplier Avanti issues shrimp recall due to salmonella risk - Albertsons Companies announced removal of certain Waterfront Bistro shrimp cocktail rings with sauce, in cooperation with supplier Avanti Frozen Foods Pvt. Ltd.'s recall. The shrimp has the potential to be contaminated with Salmonella. The 16-ounce Waterfront Bistro shrimp cocktail ring with sauce was supplied by Avanti Frozen Foods and was available for purchase in California, New Mexico and Texas from the following store banners: Albertsons, Vons, Pavilions, United, Amigos, Market Street and Albertsons Market. Customers may have purchased the shrimp in stores, online for Drive Up and Go or grocery delivery. The Waterfront Bistro shrimp cocktail ring comes in a 16-ounce container and includes a 4-ounce container of cocktail sauce. This is sold frozen. The round plastic container is clear on the top with a black bottom. The Waterfront Bistro logo is visible on the label in the center of the container which describes the product as cooked in shell, deveined shrimp cocktail with sauce. The affected product has a best before date of 10/30/2022 or 10/31/2022 and may have been purchased at one of the banners listed above beginning in January 2021. To date there have not been any reports of Salmonella-related illness associated with Waterfront Bistro shrimp cocktail rings.
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TWI | Hot Stocks20:14 EDT Titan International added to Russell 3000 Index - Titan International announced that it has been added as a member of the broad-market Russell 3000 Index, effective after the US market opened today, as part of the 2021 Russell indexes reconstitution. "We are pleased with the addition to the Russell 3000 Index," stated Paul Reitz, President and Chief Executive Officer of Titan. "Inclusion in this index further highlights the progress we have made during the past twelve months and should assist in continuing to expand our reach and support greater awareness of Titan within the investment community."
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BMEA | Hot Stocks19:11 EDT Biomea Fusion names Franco Valle CFO - Biomea Fusion (BMEA) announced the appointment of Franco Valle as Chief Financial Officer. Valle is an accomplished financial expert who brings extensive experiences to Biomea, in particular with building the necessary infrastructure to support clinical and operational growth within biotech companies, the company said. Valle will also assume the role of Principal Financial Officer and Principal Accounting Officer upon joining. Valle recently served as Principal Accounting Officer & Senior Vice President of Finance at Eidos (BBIO).
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ETSY | Hot Stocks18:50 EDT Etsy CEO: Combination with Elo7 is a perfect marriage - In an interview on CNBC's Mad Money, Josh Silverman said e-commerce in Brazil is really poised for growth. The Elo7 business is modeled after Etsy, he added. Silverman thinks the opportunity for Brazil's e-commerce sector to grow is huge. He noted that resale is currently the biggest opportunity in e-commerce and Depop is uniquely suited to that trend. The company is driven by GenZ which comprises 90% of its customers, he said.
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ROGFF FSM | Hot Stocks18:37 EDT Fortuna, Roxgold shareholders approve business combination - Fortuna Silver Mines Inc. (FSM) and Roxgold Inc. (ROGFF) announced that shareholders of both Fortuna and Roxgold have approved all matters voted on at Fortuna's annual and special meeting as well as at Roxgold's special meeting and annual meeting held earlier today, including the proposed acquisition by Fortuna of all of the outstanding common shares of Roxgold by way of a proposed plan of arrangement, pursuant to the terms and subject to the conditions of the arrangement agreement between Fortuna and Roxgold dated effective April 26, 2021. Subject to the satisfaction or waiver of the remaining conditions to the Arrangement, including approval of the Arrangement by the British Columbia Supreme Court, which application will be heard June 30, 2021, closing of the Arrangement is expected to occur on July 2, 2021. Following completion of the Arrangement, current Fortuna shareholders and former Roxgold shareholders will own approximately 63.6% and 36.4% of the outstanding Fortuna Shares, respectively. Post-arrangement, Fortuna will continue under the name "Fortuna Silver Mines Inc." with the ticker symbol "FVI" on the Toronto Stock Exchange and "FSM" on the New York Stock Exchange, and Roxgold will be a wholly-owned subsidiary of Fortuna. Roxgold will be delisted from the Toronto Stock Exchange and an application will be made for Roxgold to cease to be a reporting issuer.
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GS | Hot Stocks18:34 EDT Goldman Sachs plans to increase dividend to $2.00 from $1.25 per share - On June 24, the Federal Reserve notified the firm of the Stress Capital Buffer for The Goldman Sachs Group of 6.4%, resulting in a Standardized Common Equity Tier 1 ratio requirement of 13.4%, which will become effective on October 1. The net decrease in the SCB of 20 basis points is the result of an improvement of 40 basis points in peak to trough CET1, attributed to the firm's efforts to reduce the stress capital intensity of its businesses, offset by 20 basis points associated with the planned increase in the common stock dividend from $1.25 to $2.00 per share. "We are encouraged by the progress in reducing the capital intensity of our business as reflected in the recent stress test results," said Chairman and CEO David Solomon. "The planned increase in our dividend demonstrates our confidence in the increasing durability of our franchise revenues and is consistent with our capital management framework of prioritizing investment in our client franchise and returning excess capital to shareholders."
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SNSE | Hot Stocks18:24 EDT Sensei reprioritizes pipeline programs to focus on product candidates - Sensei Biotherapeutics announced that it is reprioritizing its pipeline programs to focus on its product candidates, including its multi-antigenic next generation ImmunoPhage candidate, now referred to as SNS-401-NG, and its monoclonal antibody SNS-VISTA candidate. With this reallocation of resources, Sensei expects its cash and cash equivalents will be sufficient to fund its operations into the first half of 2024. "Sensei's approach to drug development is deeply rooted in targeting key mechanisms of checkpoint resistance to induce a robust, focused and coordinated immune response to cancer. We believe our next generation, multi-antigenic ImmunoPhage product candidates have the potential to drive robust antigen-specific T cell responses that will translate into clinical benefit," said John Celebi, president and chief executive officer of Sensei Biotherapeutics. "Given the totality of data generated to-date from the Phase 1/2 combination trial of first-generation SNS-301, we believe we have captured important insights into the power of our ImmunoPhage platform that will further advance development of our pipeline product candidates. Through SNS-301, we have gained important information on key product attributes that we believe contribute to the safety and immunogenicity of our ImmunoPhage platform as well as how to manufacture and scale our product candidates. Specifically, we have learned that the use of gpD fusion as an antigen display technology is suboptimal for use in an active cancer vaccine. We believe the incorporation of new antigen attachment technologies will ensure optimal immunogenicity. We are excited by our next generation programs, and we look forward to further advancing our two ongoing programs SNS-401-NG and SNS-VISTA into the clinic and completing discovery work for our VSIG4 antibody program."
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AMZN | Hot Stocks18:01 EDT Amazon Meeting Center designated as official cooling center in Seattle - With temperatures expected to surpass Seattle's record high on Monday and reach 107 degrees, the City of Seattle has designated the Amazon Meeting Center as an official cooling center with a capacity of 1,000 individuals. Amazon's Meeting Center, located at 2031 7th Avenue, will be open on Monday, June 28 from 10 a.m. - 8 p.m. as a cooling center. Reference Link
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TCON | Hot Stocks17:58 EDT Tracon Pharma's treatment of soft tissue sarcoma receives FDA Orphan designation - According to a post on the FDA's website, Tracon Pharmaceuticals' treatment of soft tissue sarcoma, envafolimab, received Orphan designation. Reference Link
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PNC | Hot Stocks17:47 EDT PNC Financial to recommend 9% dividend hike, $2.9B share repurchase plan - The PNC Financial Services Group last week received the results of the Federal Reserve's 2021 Comprehensive Capital Analysis and Review. The results included the Federal Reserve's estimate of PNC's minimum capital ratios for the period from the first quarter of 2021, through the first quarter of 2023, under the Supervisory Severely Adverse Scenario. Based on its strong results, PNC's Stress Capital Buffer for the four-quarter period beginning Oct. 1, 2021, applicable to PNC inclusive of the BBVA USA acquisition, is 2.5%, which is the regulatory floor and the minimum SCB amount. PNC's Common Equity Tier 1 ratio significantly exceeds the regulatory minimum plus our SCB, reflecting our strong capital levels. PNC plans to recommend to its board of directors an increase in the quarterly cash dividend on common stock of 10c per share, or 9%, to $1.25 per share in the third quarter, consistent with the capital plan approved by its board. PNC's board of directors is expected to consider this recommendation at its next scheduled meeting on July 1. In addition, PNC plans to reinstate its share repurchase programs with repurchases of up to $2.9B for the four-quarter period beginning in the third quarter. PNC's common share repurchases may be executed in privately negotiated transactions or through the open market, including under Rule 10b5-1 plans. The timing and amount of executed repurchases will be based on market conditions and other factors, including the integration of BBVA USA. Common share repurchases will be made under the 100M share repurchase program approved by PNC's board of directors in April 2019.
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WFC | Hot Stocks17:37 EDT Wells Fargo plans roughly $18B in share repurchases
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WFC | Hot Stocks17:37 EDT Wells Fargo to raise quarterly dividend to 20c per share from 10c - Wells Fargo announced that it has completed the 2021 Comprehensive Capital Analysis and Review stress test process. The company expects its stress capital buffer to be 3.1%, which represents a percentage amount of incremental capital the company must hold above its minimum regulatory capital requirements. The Federal Reserve Board has indicated that it will publish the company's final SCB by August 31, 2021. The company expects to increase its third quarter 2021 common stock dividend to 20c per share from 10c per share, subject to approval by the company's Board of Directors at its regularly scheduled meeting in July. Additionally, the company's capital plan includes common share repurchases of approximately $18B for the four-quarter period beginning third quarter 2021 through second quarter 2022. The company will continue to prudently manage capital levels based on its internal capital adequacy framework. "We are pleased that this year's CCAR stress test confirmed the significant strength of our capital position. Since the COVID-19 pandemic began, we have built our financial strength while providing significant support to our employees, customers, and communities, as well as continuing to remediate our legacy issues. We will continue to do so as we return a significant amount of capital to our shareholders," said CEO Charlie Scharf. "The expected increase in our dividend is a priority, and our plan contemplates it will continue to increase as we grow earnings capacity, subject to future stress test results. We will also regularly evaluate market conditions, remaining pandemic related risks, and other risk factors, which may result in adjustments to the timing or amount of our expected capital actions."
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BK | Hot Stocks17:21 EDT BNY Mellon to raise quarterly dividend 10%, repurchase up to $6B of common stock - On June 24, the Federal Reserve released the results of the 2021 bank stress test, which demonstrates the resilience and strength of BNY Mellon's business model and capital position. The Federal Reserve also notified the company that its Stress Capital Buffer requirement, effective October 1, will remain 2.5%, equal to the regulatory minimum. The Federal Reserve's recent restrictions on common stock dividends and share repurchases applicable to the large banks that are subject to the supervisory stress test, including BNY Mellon, will end after June 30. The company intends to increase its quarterly cash dividend on its common stock by approximately 10% from 31c to 34c per share, commencing as early as the third quarter, subject to board approval. Additionally, BNY Mellon's board of directors has authorized the repurchase of up to $6B of the company's common stock over the six quarters beginning in the third quarter and continuing through the fourth quarter of 2022. This new authorization replaces all previously authorized share repurchase plans and, in conjunction with the SCB framework, provides management flexibility to manage the extent and timing of the company's capital distributions. The timing, manner and amount of repurchases is subject to various factors, including the company's capital position and prevailing market conditions.
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BA | Hot Stocks17:21 EDT Boeing awarded $128.84M Air Force contract - Boeing has been awarded a $128.84M firm-fixed-price contract for the F-15 Mission Training Center, or MTC, simulation services to support the Air Combat Command, Pacific Air Forces and Air Force in Europe locations. The contractor will provide all personnel, equipment, supplies, transportation, tools, materials, supervision and other items to perform all MTC services. These services will provide simulation capability to train F-15 pilots and system operators in high-fidelity training devices. Work is expected to be completed Dec. 31. FY21 operation and maintenance funds in the amount of $13.18M are being obligated at the time of award. Air Force Life Cycle is the contracting activity.
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DTM... | Hot Stocks17:18 EDT DT Midstream to replace PRA Health in S&P 400 at open on 7/2 - Icon (ICLR) is acquiring PRA Health Sciences (PRAH) in a deal expected to be completed soon pending final closing conditions. DTE Energy (DTE) is spinning off DT Midstream (DTM) in a transaction expected to be effective prior to the open on Thursday, July 1. Post spin-off, DTE Energy will remain in the S&P 500.
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USB | Hot Stocks17:13 EDT U.S. Bancorp receives SCB of 2.5%, recommends Q3 dividend increase - U.S. Bancorp commented on the results of the Federal Reserve's 2021 Dodd-Frank Act stress test. Based on its 2021 stress test results, the company will be subject to a stress capital buffer requirement, or SCB, of 2.5% for the period beginning October 1 and ending on September 30, 2022. The SCB, when added to the Basel III Common Equity Tier 1, or CET1, minimum of 4.5%, requires the company to maintain a CET1 ratio above 7% through this period. The company's CET1 ratio was 9.9% as of March 31 under CECL transition rules. The Federal Reserve also announced that the capital restrictions instituted in Q3 of 2020 in response to the economic uncertainty from the COVID-19 pandemic will expire on June 30. As a result, the company will recommend that its board of directors approve a 9.5% increase to its Q3 dividend payable in October. The company expects to recommend a Q3 dividend of 46c per common share, equivalent to an annual dividend of $1.84 per common share. U.S. Bancorp's existing share repurchase program announced in December 2020 remains in effect.
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C | Hot Stocks17:09 EDT Citi 2021 Stress Capital Buffer requirement to increase to 3.0% from 2.5% - The Federal Reserve Board communicated that Citi's 2021 Stress Capital Buffer requirement will increase from the currently effective requirement of 2.5% to 3.0% for the four quarter window of 4Q 2021 - 3Q 2022. Incorporating this SCB, and a GSIB surcharge of 3.0%, results in a minimum regulatory requirement of 10.5% under the Standardized Approach, effective October 1, 2021. Citi's minimum regulatory requirement under the Advanced Approaches (using the fixed 2.5% Capital Conservation Buffer) will remain unchanged at 10.0%. As of the first quarter of 2021, Citi's Common Equity Tier 1 Capital ratio was 11.8% under both the Standardized and Advanced Approaches. Based on Citigroup's updated regulatory capital requirements, Citi continues to believe that a targeted Common Equity Tier 1 Capital ratio of approximately 11.5% represents the amount necessary to prudently operate and invest in Citi's franchise. Jane Fraser, Citi CEO, said: "The latest CCAR results further demonstrate Citi's resiliency, as well as the strength of our capital position to withstand a variety of changing risks and circumstances. Throughout this crisis we have served as a source of strength for our customers, clients and communities and have embraced the opportunity to help lead the economic relief and recovery efforts. Our targeted Common Equity Tier 1 Capital ratio already contemplates periodic volatility in regulatory capital requirements under the SCB framework. We look forward to continuing with our planned capital actions, including common dividends of at least $0.51 per share, and to continuing share repurchases, which are particularly attractive when our stock price is below tangible book value per share. Citi remains committed to continuing to invest in our franchise as part of the firm's broader strategy refresh as well as continuing to return any excess capital to shareholders given the flexibility provided by the SCB framework." By the end of the first two quarters of this year, Citi will have returned to shareholders the maximum amount of capital permitted under Federal Reserve rules. All planned capital actions are subject to financial and macroeconomic conditions, and approval by Citi's Board of Directors.
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TFX | Hot Stocks17:05 EDT Teleflex completes portion of respiratory business to Medline Industries - Teleflex announced it has completed the previously announced divestiture of a significant portion of its Respiratory business to Medline Industries or $286M in cash, reduced by $12M in working capital not transferring to Medline. The divested Teleflex respiratory product lines include Hudson RCI products for oxygen and aerosol therapy, active humidification, non-invasive ventilation, and incentive spirometers, all of which generated $139 million in revenue in 2020. In 2021, the divested respiratory product lines were expected to contribute net revenue approximately flat with the $139M in 2020. Based on the date of closing, the company estimates a revenue headwind of $28-$32M and adjusted earnings per share dilution of 10c-15c in 2021 or approximately 1% of 2021 adjusted earnings per share, net of a manufacturing services agreement that Teleflex has entered into with Medline as of the initial closing of the sale transaction. Teleflex intends to use the proceeds from the divestiture to pay down debt, augmenting its financial flexibility to support its growth strategy.
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BZUN | Hot Stocks17:01 EDT Baozun acquires eFashion China, terms not disclosed - Baozun announced that it has signed a definitive agreement to acquire 100% equity interest in Shanghai Yi Shang Network Information Co Ltd, a provider of e-commerce solutions for fashion brands in China, in an all-cash transaction. The acquisition is subject to the satisfaction of customary closing conditions and is expected to be completed in the third quarter of 2021. Vincent Qiu, Chairman and Chief Executive Officer of Baozun commented, "We are pleased to welcome eFashion China's team into the Baozun family. We are excited about this acquisition as both Baozun and eFashion China share an ambition and commitment to bring global fashion brands to the fast-growing China e-commerce market. eFashion China brings a strong understanding of apparel brands, efficient cost structure, and impressive track record of high service quality. We believe our combined strengths will deliver unique added value to our brand partners of various stages of growth and sizes."
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AAPL... | Hot Stocks16:57 EDT Global mobile app spending rose 24% y/y in 1H21, says Sensor Tower - Global consumer spending in mobile apps reached $64.9B across Apple's (AAPL) App Store and Alphabet's (GOOGL) Google Play in the first half of 2021, according to preliminary Sensor Tower Store Intelligence estimates and projections through June 30. This was 24.8% more than the $52B generated by both stores in the same period in 2020. Although spending continued to climb to new heights, the year-over-year growth experienced by mobile markets so far this year trailed that experienced in 2020, the firm said. In the first half of last year, the pandemic boosted consumer spending by 28.4% Y/Y when compared to approximately $40.5B in the first half of 2019. Apple's App Store is projected to generate $41.5B in consumer spending globally from in-app purchases, subscriptions, and premium apps and games in the first half of 2021. This is about 1.8 times the revenue generated by Google Play, which saw an estimated $23.4B in the same period. However, Google's marketplace is projected to experience more Y/Y growth than Apple's. In the first half of 2021, the App Store has grown 22.1% from about $34B in the H1 2020, a little more than 7 percentage points lower than the 29.3% growth experienced during 1H20 due to accelerated spending during the onset of the COVID-19 pandemic. Reference Link
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COF | Hot Stocks16:47 EDT Capital One announces SCB is 2.5% effective October 1 - Capital One announced the company's Stress Capital Buffer Requirement, or SCB, as calculated by the Federal Reserve Comprehensive Capital Analysis and Review process, or CCAR, is 2.5%, effective October 1. The company's previously disclosed SCB of 5.6%, as calculated by the Federal Reserve 2020 CCAR process, will remain in effect for Q3.
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TFC | Hot Stocks16:47 EDT Truist Financial announces planned quarterly dividend raise of 7% to 48c - Truist Financial announced a planned 7% increase in the regular quarterly common dividend from 45c per share to 48c per share, following the completion of the 2021 Comprehensive Capital Analysis and Review process. This increase would take effect in the third quarter. Truist's dividends are subject to approval by its board of directors, and the third quarter dividend will be considered by the Truist board at its upcoming meeting. Truist also announced that the Federal Reserve Board reduced the preliminary stress capital buffer to which Truist will be subject from 2.7% to 2.5%. The new preliminary SCB is in effect from Oct. 1, 2021 to Sept. 30, 2022, and reflects Truist's prudent risk management and sound financial performance under stressful conditions.
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BAC | Hot Stocks16:45 EDT Bank of America raises quarterly dividend 17% to 21c per share - Bank of America commented on the results of the Federal Reserve's 2021 Comprehensive Capital Analysis and Review and announced plans to increase its quarterly common stock dividend by 17%. Based on the 2021 CCAR results, Bank of America will be subject to a preliminary 2.5 percent stress capital buffer, unchanged from the current level. This SCB will be effective from October 1, 2021 to September 30, 2022 and, when combined with the Basel 3 common equity tier 1 minimum of 4.5 percent, and the Global Systemically Important Bank Surcharge of 2.5 percent, will equate to a minimum CET1 ratio under applicable regulatory standards of 9.5 percent, which is unchanged from its current level. At March 31, 2021 Bank of America's CET1 ratio was 11.8 percent, which equated to approximately $35 billion in excess CET1 capital. "Our decade-long focus on responsible growth has put us in a strong position to support consumers, businesses and communities while delivering for shareholders," said Bank of America Chairman and Chief Executive Officer Brian Moynihan. "In April, we announced a plan to repurchase up to $25 billion of common stock over time, and today we are also announcing that we expect to increase the quarterly common stock dividend by 17 percent to $0.21 per share, beginning in the third quarter of 2021." The common stock dividend is subject to approval from the company's Board of Directors.
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FCPT | Hot Stocks16:44 EDT Four Corners Property Trust acquires Stanton Optical property for $2.1M - Four Corners Property Trust is pleased to announce the acquisition of a Stanton Optical property for $2.1M. The property is located in a highly trafficked retail corridor in Wisconsin and is occupied under a triple net lease to the brand's corporate entity with approximately seven years of term remaining. The transaction was priced at a 6.5% going-in cash capitalization rate, exclusive of transaction costs.
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BTC... | Hot Stocks16:42 EDT Cathie Wood's ARK files to form ARK 21Shares Bitcoin - Cathie Wood's ARK Investment announced in a regulatory filing the ARK 21Shares Bitcoin ETF, an exchange-traded fund that issues common shares of beneficial interest that trade on the Cboe BZX Exchange, Inc. The Trust's investment objective is to seek to track the performance of bitcoin, as measured by the performance of the S&P Bitcoin Index, adjusted for the Trust's expenses and other liabilities. S&P Dow Jones Indices LLC is the publisher and index administrator for the Index. The Index is designed to reflect the performance of bitcoin in U.S. dollars. In seeking to achieve its investment objective, the Trust will hold bitcoin and will value its Shares daily based on the Index. 21Shares US LLC is the sponsor of the Trust, Delaware Trust Company is the trustee of the Trust, and Coinbase Custody Trust Company, LLC is the custodian for the Trust, and will hold all of the Trust's bitcoin on the Trust's behalf. ARK Investment Management LLC provides assistance in the marketing of the Shares, according to the filing. Reference Link
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JPM | Hot Stocks16:39 EDT JPMorgan to raise quarterly dividend to $1.00 per share from 90c - JPMorgan Chase announced that it has completed the Federal Reserve's 2021 Comprehensive Capital Analysis and Review stress test process. The Firm's indicative Stress Capital Buffer requirement is 3.2% and the Firm's minimum Standardized Common Equity Tier 1 capital ratio is 11.2%. The Federal Reserve Board will provide the Firm with its final SCB requirement by August 31, 2021, and that requirement will become effective on October 1, 2021 and will remain in effect until September 30, 2022. JPMorgan Chase's Board of Directors intends to increase the quarterly common stock dividend to $1.00 per share, up from the current 90c per share, for the third quarter of 2021. The Firm's quarterly common stock dividends are subject to approval by the Board of Directors at the customary times that those dividends are declared. The Firm continues to be authorized to repurchase common shares under its existing common share repurchase program previously approved by the Board of Directors.
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SJW | Hot Stocks16:37 EDT SJW unit files applications to acquire Kendall West, Bandera East utilities - SJW Group announced that its Texas subsidiary, SJWTX Inc., which does business as Canyon Lake Water Service Company, is planning to acquire the Kendall West Utility operating in Kendall County and the Bandera East Utility in Bandera and Medina Counties, Texas. The companies have filed applications with the Public Utilities Commission of Texas for approval of the transactions. Eric W. Thornburg, chairman, president and CEO of SJW Group, stated, "We are eager to serve the customers of Kendall West and Bandera East Utilities as part of our Canyon Lake Water Service Company. This transaction, if approved by the PUCT, will benefit all of our customers through increased scale and greater resources. We look forward to delivering exceptional drinking water and wastewater services to them in the future."
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STT | Hot Stocks16:35 EDT State Street raises quarterly dividend 10% to 57c per share - State Street announced its preliminary stress capital buffer requirement of 2.5%, effective October 1, 2021, and the intention to increase its quarterly common stock dividend by 10% to 57c per share in the third quarter, subject to consideration and approval by its Board of Directors. State Street's calculated SCB under this year's supervisory stress test was well below the 2.5% minimum, preliminarily resulting in an SCB at that floor. The firm's capital position remains strong and the Company intends to continue share repurchases in upcoming quarters, subject to approval by its Board of Directors, which will be discussed further on our second quarter earnings call. "We are pleased with our solid performance under the 2021 annual stress test, which is another testament to the resiliency and capital stability of our business model. The strength of our balance sheet and capital levels enable us to operate effectively and with resilience, while also positioning us to continue to return capital to our shareholders," said Chairman and Chief Executive Officer Ron O'Hanley. State Street's Board of Directors will consider the common stock dividend at a regularly scheduled board meeting in the third quarter of 2021. State Street's third quarter 2021 common stock and other stock dividends, including the declaration, timing and amount, remain subject to consideration and approval by State Street's Board of Directors at the relevant times.
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MDVL | Hot Stocks16:35 EDT Medavail added to Russell 2000, 3000 Indexes - MedAvail Holdings announced that it has been added to the Russell 2000 Index and the broad-market Russell 3000 Index effective after the U.S. market opened on June 28, 2021, following the 2021 Russell indexes annual reconstitution. Annual reconstitution of the Russell indexes captures the 4,000 largest U.S. stocks as of May 7, 2021, ranking them by total market capitalization. Membership in the Russell 3000 Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
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CPRX | Hot Stocks16:34 EDT Catalyst Pharmaceuticals comments on Health Canada reissuance of Ruzurgi NOC - Catalyst Pharmaceuticals commented on the recent decision by Health Canada to re-issue a notice of compliance, or NOC, for Ruzurgi, once again allowing the product to be marketed in Canada for patients with Lambert-Eaton Myasthenic Syndrome. or LEMS. Health Canada's original NOC for Ruzurgi for marketing in Canada was quashed in a recent decision of the Federal Court of Canada, which sent the matter back to Health Canada to re-determine its decision to grant marketing authority to Ruzurgi despite Firdapse's data protection rights under Canadian law. Patrick McEnany, Catalyst's chairman and CEO commented: "We are obviously disappointed with Health Canada's decision to re-issue an NOC for Ruzurgi(R). Our effort to get Firdapse(R) approved in Canada commenced three years ago, at a time when there was no approved therapy in Canada to treat LEMS patients. Our interest was to assure that all adult LEMS patients had access to a Health Canada approved therapy, despite recognizing that our market opportunity in Canada was always expected to be small." Catalyst and its Canadian sublicensee, KYE Pharmaceuticals, are currently evaluating their further litigation options to challenge Health Canada's most recent decision, since such decision means that the data protection that Catalyst and KYE are entitled to under Canadian law has not been recognized by Health Canada.
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MS | Hot Stocks16:33 EDT Morgan Stanley authorizes stock buyback of up to $12B
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MS | Hot Stocks16:32 EDT Morgan Stanley to double quarterly dividend to 70c per share - Morgan Stanley announced that it will double its quarterly common stock dividend to 70c per share from the current 35c per share, beginning with the common dividend expected to be declared by the Firm's Board of Directors in the third quarter of 2021. In addition, the Firm announced a new increased repurchase authorization of outstanding common stock of up to $12B through June 30, 2022. James P. Gorman, Chairman and Chief Executive Officer of Morgan Stanley, said, "The Board of Directors has approved a 100 percent increase in our dividend and an increase of our share repurchase program to $12 billion. Morgan Stanley has accumulated significant excess capital over the past several years and now has one of the largest capital buffers in the industry. The action taken by the Board reflects a decision to reset our capital base consistent with the needs we have for our transformed business model. In particular, Wealth Management and Investment Management provide stable and durable earnings that support a significantly higher payout ratio. Going forward we remain amply capitalized to drive further growth." On June 24, 2021, the Board of Governors of the Federal Reserve System released its CCAR 2021 results, as a result of which Morgan Stanley will be subject to a Stress Capital Buffer of 5.7 percent from October 1, 2021 to September 30, 2022. Together with other features of the regulatory capital framework, this SCB results in an aggregate U.S. Basel III Standardized Approach Common Equity Tier 1 ratio of 13.2 percent. The Firm's U.S. Basel III Standardized Approach CET1 ratio was 16.7 percent as of March 31, 2021.
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RF | Hot Stocks16:31 EDT Regions Financial board to consider dividend increase - The Federal Reserve has communicated to Regions Financial Corp. that the company exceeded all minimum capital levels under the Federal Reserve's Supervisory Stress Test. Regions voluntarily participated in the 2021 test as an opportunity to both measure and demonstrate the strength of Regions' balance sheet and capital base. Regions' preliminary Stress Capital Buffer requirement for the fourth quarter of 2021 through the third quarter of 2022, as determined by the Federal Reserve, will be floored at 2.5%. Regions believes its sound approach to risk management, including the company's proactive interest rate risk management program, continues to support long-term, sustainable performance through economic cycles. Regions maintains an ongoing and robust capital planning process designed to ensure the efficient use of capital while maintaining a long-term approach to capital allocation and distribution consistent with the bank's strategic priorities. Regions is committed to managing the Common Equity Tier 1 capital ratio in a range over time, currently 9.25-9.75%. Additionally, Regions' Board of Directors will consider an increase in Regions' quarterly common stock dividend, effective for the third quarter of 2021, at the Board's regularly scheduled meeting in July 2021.
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ABG | Hot Stocks16:27 EDT Asbury Automotive announces resignation of CFO Patrick Guido - Asbury Automotive Group announced that Patrick Guido provided notice of his decision to resign from the position of Senior Vice President & CFO of the company effective June 24 for personal reasons. The company also announced that William Stax, Vice President, Corporate Controller & Chief Accounting Officer of the company, was appointed as interim Principal Financial Officer effective June 25 while the company conducts a search for a new CFO.
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TWND | Hot Stocks16:25 EDT Tailwind Acquisition urges stockholders to vote for QOMPLX deal before July 20 - Tailwind Acquisition Corp. said it is reminding its stockholders to vote in favor of the proposed business combination with QOMPLX, Inc. and the related proposals at the Tailwind Special Meeting. Tailwind's stockholders of record as of June 2, 2021, the record date for the Special Meeting are entitled to vote their shares of Tailwind common stock at the Special Meeting. Every stockholder's vote is important, regardless of the number of shares the stockholder holds. As such, all stockholders of record as of the record date who have not yet voted are encouraged to do so as soon as possible before July 20, 2021.
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USDP | Hot Stocks16:24 EDT USD Partners enters Terminal Services Agreement with USD Clean Fuels - USD Partners announced that the Partnership has entered into a Terminal Services Agreement with USD Clean Fuels, a newly-formed subsidiary of US Development Group. The Terminal Services Agreement provides for the inbound shipment of renewable diesel on rail and the outbound shipment of the product on tank trucks to local consumers. The agreement has an initial term of five years with a target commencement date of December 1, 2021, and is supported by a minimum throughput commitment to USDCF from an investment-grade rated, refining customer as well as a performance guaranty from USDG. "We are excited to announce this very accretive opportunity at the Partnership. This opportunity is incremental to our existing ethanol business at West Colton and is projected to generate additional Adjusted EBITDA of approximately $2.0 million per year at the Partnership over the five-year term," said Adam Altsuler, the Partnership's Chief Financial Officer. "Total capital associated with the opportunity is approximately $1.8 million, which we intend to fund from cash flows from operations." USDCF is a newly-created entity formed by USDG, the Partnership's sponsor, to focus on providing production and logistics solutions to the growing market for clean energy transportation fuels.
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UBA | Hot Stocks16:23 EDT Urstadt Biddle sells Newington Park Shopping Center for $13.35M - Urstadt Biddle announced that it has completed the sale of its Newington Park Shopping Center located in Newington, New Hampshire. The purchaser is a subsidiary of Torrington Properties, a real estate investment and development company based in Boston, Massachusetts and Durham, New Hampshire. The sale price was $13.35M.
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JEF | Hot Stocks16:21 EDT Jefferies Financial Group raises annual dividend 25% to $1.00 per share - The Jefferies Board of Directors declared a quarterly cash dividend equal to 25c per Jefferies common share, a 25% increase on the prior dividend rate, payable on August 27 to record holders of Jefferies common shares on August 16.
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BRT | Hot Stocks16:18 EDT BRT Apartments enters contracts to sell two multi-family properties for $226M - BRT Apartments announced that it entered into contracts to sell two multi-family properties, both of which are owned by an unconsolidated joint venture for approximately $226M and expects to recognize its share of the gain, net of any prepayment penalty, of between $28M and $30M from the sale of these properties. These properties, Parc at 980, a 586 unit property located in Lawrenceville, Georgia and The Avenue Apartments, a 522 unit apartment located in Ocoee, Florida, are being sold for $118.3M and $108M, respectively. Both properties are owned by an unconsolidated joint venture in which BRT has a 50% interest. The aggregate debt on the properties is $107.5M which will be repaid or assumed by the buyers. Net proceeds to BRT after the repayment of such debt, the mortgage prepayment charge and closing costs are estimated to be approximately $46M. These transactions, which are subject to customary closing conditions, are expected to close by the end of Q3. BRT also announced it is under contract to sell to its joint venture partners BRT's 76% interests in the unconsolidated subsidiaries that own The Tower at Opop and Lofts at Opop, with an aggregate of 181 units located in downtown St. Louis, Missouri, for $3M. BRT will recognize an impairment charge of approximately $510,000 in the second quarter. The aggregate mortgage debt on these properties total $26.2M. During the year ended December 31, 2020, these four properties generated an aggregate of $929,000 of equity in loss from unconsolidated joint ventures, including an aggregate of $3.6M of depreciation and $3.2M of interest expense. These transactions are subject to customary closing conditions.
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FLMN | Hot Stocks16:17 EDT Falcon Minerals names Bryan Gunderson as CEO, Matthew Ockwood as CFO - Falcon Minerals announces the appointment of Bryan Gunderson as President and CEO and the departure of Daniel Herz, former President and CEO. Gunderson's appointment and Herz's departure are both effective immediately. Gunderson has also been appointed to the Board of Directors to fill the vacancy created by Herz's resignation. Falcon's Board of Directors has also hired Matthew Ockwood to serve as CFO. Ockwood joins Falcon as an experienced oil and gas investor, most recently serving as a Managing Director and member of the investment committee for Chambers Energy Capital.
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TBLA IACA | Hot Stocks16:16 EDT Ion Acquisition Corp. 1 shareholders approve Taboola combination - Taboola (TBLA), a player in powering recommendations for the open web, announced that Ion Acquisition Corp. 1, Ltd's (IACA) stockholders voted to approve the previously announced business combination. The vote took place during a special meeting today and final voting results are being filed by ION with the Securities and Exchange Commission on Form 8-K. The closing of the business combination is expected to take place on June 29. The transaction will generate approximately $526 million upon closing, given the very low redemptions by ION shareholders. Following the closing, the company's ordinary shares and warrants will begin trading on the Nasdaq Global Select Market beginning on June 30 under the ticker symbols "TBLA" and "TBLAW" respectively.
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CHMA | Hot Stocks16:13 EDT Chiasma submits MAA for MYCAPSSA to European Medicines Agency - Chiasma announced that it has submitted a Marketing Authorization Application to the European Medicines Agency seeking approval of MYCAPSSA as a maintenance therapy for adults with acromegaly.
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GILD | Hot Stocks16:10 EDT Gilead submits NDA to FDA for lenacapavir - Gilead Sciences announced that the company completed submission of a New Drug Application to the U.S. Food and Drug Administration seeking approval of lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The submission is supported by data from the Phase 2/3 CAPELLA trial, which evaluated the safety and efficacy of lenacapavir administered subcutaneously every six months in combination with an optimized antiretroviral background regimen. Key data on lenacapavir will be presented during the 11th International AIDS Society Conference on HIV Science in July 2021. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs. Lenacapavir, which is being studied as an every-six-month subcutaneous injection, is a potential first-in-class capsid inhibitor for the treatment of HIV-1 infection without overlapping resistance with any currently approved antiretroviral therapy.
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QTRX | Hot Stocks16:08 EDT Quanterix names Michael Doyle CFO - Quanterix Corporation announced that it has named Michael Doyle to the position of Chief Financial Officer and Treasurer, effective July 12, 2021. Doyle replaces Shawn Stetson, who has served as the Company's Interim Chief Financial Officer and Treasurer. "Mike is a strong financial executive with deep experience serving as a public company CFO, and in light of our company's continued growth and opportunity to transform healthcare through our non-invasive early detection technology, we welcome his business acumen as we scale and strengthen our executive team with top talent," said Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix and Founder of Powering Precision Health Foundation. "Mike's track record for driving organic and inorganic growth coupled with his strong experience scaling businesses processes and financial organizations is a rare find and should serve us well as we scale our research and diagnostic opportunity."
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MLHR | Hot Stocks16:07 EDT Herman Miller reports Q4 gross margin 36% vs. 34.9% a year ago
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MCFT | Hot Stocks16:07 EDT MasterCraft Boat announces up to $50M share repurchase program - MasterCraft Boat announced that its board of directors has authorized a new share repurchase program under which the company may repurchase up to $50M of its outstanding shares of common stock during the three-year period ending June 24, 2024. MasterCraft also announced that it has successfully closed on a new $160M credit facility, consisting of a $60M term loan and a $100M revolving credit facility, of which $33.7M is drawn on the revolver as of the date of this filing. This new credit facility, which replaced the company's previously existing senior secured credit facility, is scheduled to mature on June 28, 2026.
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FHN | Hot Stocks16:07 EDT First Horizon announces tier one capital ratio of 8.5% - First Horizon announced the results of its 2021 Bank Holding Company-run capital stress test results which demonstrate the ability to successfully navigate periods of economic stress and maintain capital ratios well above regulatory minimums. These internal results, which utilized the 2021 Severely Adverse Scenario published by the Federal Reserve on February 12, 2021, reflect continued strong risk discipline. "Our commitment to strong risk management and the benefit of our more diversified business model are highlighted by our stress test results," said William C. Losch, Chief Financial Officer. "Our minimum common equity tier one capital ratio of 8.5% continued to be well above regulatory requirements, and our stressed loss rates and pre-provision net revenue performed significantly better than the Federal Reserve published CCAR-bank medians."
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SKIN | Hot Stocks16:06 EDT Beauty Health joins Russell 3000, 2000 Indexes - The Beauty Health Company announced that it has joined the broad-market Russell 3000 and the Russell 2000 Indexes, effective today, Monday, June 28, 2021 at market open, based on the final index membership lists, which are available on the FTSE Russell website. Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of May 7th, ranking them by total market capitalization. Membership in the US all-cap Russell 3000 Index, which remains in place for one year, automatically includes the Company in the large-cap Russell 1000 Index or the small-cap Russell 2000 Index, as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
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RHE | Hot Stocks16:05 EDT Regional Health Properties set to join Russell Microcap Index - Regional Health Properties, Inc. has joined the Russell Microcap Index at the conclusion of the 2021 Russell indexes annual reconstitution effective upon the US market open on June 28, 2021, in accordance with a final list of additions posted June 28, 2021. Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
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FTCI | Hot Stocks16:05 EDT FTC Solar receives $22M in sale of Dimension Energy stake - FTC Solar announced that it has received a net payout of approximately $22M in connection with the sale of its minority investment position in Dimension Energy, with the potential to receive an additional payout of up to approximately $14M through an earn-out structure. FTC Solar made an investment of $4M in Dimension, a community solar developer based in Atlanta, in 2018. Since the time of that investment, and prior to the sale, FTC Solar has received dividends of approximately $2.1M. With the sale of its original stake, which closed on June 24, FTC Solar has received an additional net payout of approximately $22M, with the potential to receive an additional payout of up to approximately $14M through December 2024, based on Dimension achieving certain performance milestones.
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MICR | Hot Stocks15:39 EDT Contract manufacturing organization Micron Solutions announces CFO resignation - Micron Solutions, a diversified contract manufacturing organization, through its wholly-owned subsidiary, Micron Products, announced that Wayne Coll, Chief Financial Officer, Treasurer and Secretary, will be leaving the company on July 16. The company has initiated a search for Coll's replacement. At this time, the company has not appointed an interim replacement for Coll.
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MSFT | Hot Stocks15:30 EDT Xbox Cloud Gaming now open to Game Pass Ultimate members with Windows 10 PCs - Microsoft said that, starting Monday, Xbox Cloud Gaming is available to all Xbox Game Pass Ultimate members with Windows 10 PCs and Apple phones and tablets, via browser, across 22 countries. Members can go to xbox.com/play on Microsoft Edge, Chrome, or Safari on their PC or mobile device to start playing hundreds of games from the Xbox Game Pass library. "We're also making significant improvements to the overall experience: Xbox Cloud Gaming is now powered by custom Xbox Series X hardware," the company said. "We've been upgrading Microsoft datacenters around the globe with the fastest, most powerful Xbox hardware to give you faster load times, improved frame rates, and an experience of a new generation of gaming. To ensure the lowest latency, highest quality experience across the broadest set of devices, we will be streaming at 1080p and up to 60fps. Going forward we'll continue to innovate and add more features to enhance your cloud gaming experience." Reference Link
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FB | Hot Stocks15:15 EDT Facebook up 3% after district court grants motion to dismiss FTC complaint - Shares of Facebook are up $11.25, or 3%, to $352.62 in afternoon trading following a ruling issued by U.S. District Court for the District of Columbia judge James Boasberg in a suit brought by the FTC against the company.
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FB | Hot Stocks15:03 EDT Court grants Facebook motion to dismiss FTC complaint, but not case - In a ruling issued by U.S. District Court for the District of Columbia judge James Boasberg, the judge wrote: "For the foregoing reasons, the Court will grant Facebook's Motion to Dismiss, but it will dismiss without prejudice only the Complaint, not the case. The Court will also grant leave to amend and order Plaintiff to file any amended Complaint within thirty days. A contemporaneous Order so stating shall issue this day." The ruling relates to "federal and state regulators" contending in two separate actions before this Court that Facebook is violating antitrust laws. "The company, they allege, has long had a monopoly in the market for what they call 'Personal Social Networking Services.' And it has allegedly maintained that monopoly, in violation of Section 2 of the Sherman Act, through two different kinds of actions... Both suits seek equitable relief from this conduct, including forced 'divestiture or reconstruction of businesses' as well as orders not to undertake similar conduct in the future," the ruling stated. Reference Link
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FB | Hot Stocks15:01 EDT FTC antitrust case against Facebook dismissed, The Information's Josh Sisco says - The Information's Josh Sisco said via Twitter that, "Court dismisses FTC's antitrust case against Facebook." "The court orders that Facebook's motion to dismiss is granted; plaintiff's complaint is dismissed without prejudice; and plaintiff shall file any amended complaint by July 29, 2021," according to a picture of the filing shared by the reporter.Reference Link
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PTNR | Hot Stocks14:47 EDT Partner 'examining the implications' of MOC shutdown of 2G and 3G networks - Partner Communications reports, following that stated in sections 4B.8-"Our Network" and 4B.12e-x "Hearings and Examinations" of the company's annual report for 2020 regarding the hearing published by the Ministry of Communications, or MOC, for the shutdown of 2G and 3G networks, or "the Old Technologies," by year end 2025, that on June 27, 2021, the decision of the MOC was received which determines, among other things the termination of Old Technology services on December 31, 2025, or on an earlier date, at the company's request, subject to certain conditions; a ban on the import of cellular devices that support the Old Technologies as of January 1, 2022; prohibition of connecting an existing subscriber or a new customer with equipment operating on the Old Technologies, except for security forces equipment, as of January 1, 2023; and setting the frequency allotments that were allocated at the time for the Old Technologies in the 900, 1800 and 2100 Mhz bands for usage that will also be allowed with more advanced technologies, until December 31, 2030. "The company is examining the implications of the Ministry of Communications' decisions," Partner Communication announced.
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SOAC TMC | Hot Stocks14:10 EDT DeepGreen investors approve deal with Sustainable Opportunities Acquisition - DeepGreen Metals announced that DeepGreen's securityholders passed a special resolution approving the Plan of Arrangement related to the previously-announced business combination with Sustainable Opportunities Acquisition Corp. At the DeepGreen securityholders meeting, held on June 22, 2021, the special resolution approving the Plan of Arrangement was unanimously approved, with 90.4% of the outstanding shares and 98.7% of the outstanding options represented in person or by proxy. No DeepGreen securityholders voted against the resolutions. The closing of the business combination remains subject to approval by SOAC's shareholders and the satisfaction of other customary closing conditions, and is expected to occur in the third quarter of 2021. Following the completion of the business combination, the combined entity will be renamed "TMC the metals company Inc." and is expected to begin trading on the Nasdaq Global Select Market under the ticker symbol "TMC". I want to thank all of our shareholders for their longstanding support. We are thrilled about what we have accomplished together so far, and we look forward to working with SOAC to shape the future supply chain for EV battery metals," said Gerard Barron, Chairman and CEO of DeepGreen. "The vote of our securityholders is a critical step towards listing The Metals Company and ensuring TMC has the resources to achieve its goal of becoming the world's largest producer of EV battery metals through a responsible approach with the lowest lifecycle ESG impact and low production cost."
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AMZN DIS | Hot Stocks13:53 EDT Amazon Music Unlimited customers get up to six months of Disney+ access - Amazon Music and Disney+ are offering new and existing Amazon Music Unlimited customers Disney+, Amazon (AMZN) stated in a post to its site. "Starting today, Amazon Music Unlimited customers in the U.S. and Canada will have access to some of the best new shows and films streaming on Disney+. New Amazon Music Unlimited customers in the U.S. and Canada are eligible for 6 months of Disney+ on us while existing Amazon Music Unlimited customers in those territories will receive 3 months of Disney+ on us," the company announced. Reference Link
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CDXC | Hot Stocks13:18 EDT CMA accelerates recovery in mild-to-moderate Covid-19, says Advanced Science - Researchers at Advanced Science conducted a randomized, controlled, open-label, placebo-controlled phase-2 study to evaluate the efficacy, tolerability, and safety of combined metabolic activators in ambulatory COVID-19 patients. "In the phase-2 study, we recruited 100 adults with a confirmed positive PCR test for COVID-19. Five patients dropped out for personal reasons, and two were hospitalized before administrating the CMA. Of the 93 remaining patients, all of whom completed the study, 71 were randomly assigned to the CMA group and 22 to the placebo group... In the phase-2 study, we observed that the mean recovery time (the primary outcome variable) was shorter in the CMA group than in the placebo group... In the phase-3 study, we observed that the mean recovery time was shorter in the CMA group than in the placebo group." Reference Link
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BBBY | Hot Stocks13:01 EDT Bed Bath & Beyond to begin paid parental leave, other benefits this July - Bed Bath & Beyond announced that three new paid benefit programs will be implemented on July 1, including parental leave, short-term disability, and an associate relief fund, building upon the People pillar of Bed Bath & Beyond's recently unveiled Environmental, Social and Governance strategy. The company will convert Associate-paid voluntary short-term disability program to a company-paid program, providing for 100% of pay for up to 8 weeks and 60% of pay thereafter up to 26 weeks. This program will also be offered to all U.S. benefits-eligible full-time Associates. The company also announced that it will close stores on Thanksgiving Day. "Our purpose is to make it easy to feel at home, and that begins right here with our Associates and making investments that elevate our people-powered culture," said Lynda Markoe, EVP and Chief People and Culture Officer at Bed Bath & Beyond. "We're thrilled to implement these new Company-paid programs to support the well-being of our Associates and their loved ones. As we look ahead to Thanksgiving and a return to a 'new-normal,' we want our Associates to be home, happier and be able to welcome friends and family into their homes." Bed Bath & Beyond, buybuy BABY and Harmon Face Values stores in Canada will close on October 11 in observance of Thanksgiving in Canada, while stores in the U.S. will close on November 25 for the Thanksgiving holiday.
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INTC | Hot Stocks12:19 EDT Intel: New Intel XPU innovations target HPC and AI - At the 2021 International Supercomputing Conference, Intel said it is showcasing how the company is extending its lead in high performance computing with a range of technology disclosures, partnerships and customer adoptions. The latest 3rd Gen Intel Xeon Scalable processors will power the next generation of supercomputers and high-performance computing systems, Intel said, adding that the next generation of Intel Xeon Scalable processors, or "Sapphire Rapids," will integrate High Bandwidth Memory. Intel's Xe-HPC-based Ponte Vecchio GPU has powered-on, is in system validation, and will include OAM form factor and subsystems.
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LWAY | Hot Stocks12:11 EDT Lifeway Foods announces share repurchase program up to 250,000 shares - Lifeway Foods announced that Lifeway's Board of Directors has approved a new share repurchase program of up to 250,000 shares. Under such a program, Lifeway Foods may repurchase up to 250,000 shares of the Company's Common Stock through the open market within a period of two years from the effective date of the program. The Company will use its available cash resources generated through operations to fund the stock repurchase program.
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JPM | Hot Stocks12:05 EDT JPMorgan takes 40% stake in Brazil's C6 Bank - JPMorgan Chase and C6 Bank announced that they have entered into a strategic agreement, whereby JPMorgan Chase will take a 40% ownership stake in the full-service Brazilian digital bank, subject to regulatory approvals. Financial terms of the transaction were not disclosed. "We're excited to be partnering with one of Brazil's fastest growing digital banks," said Sanoke Viswanathan, CEO of International Consumer for JPMorgan Chase. "We've admired C6 Bank, its management team and their strategy for some time. With an impressive platform and product suite, they are well-positioned to sustain their growth trajectory and build a strong franchise. We look forward to supporting C6 Bank in its aspiration to be a long-term winner in the Brazilian banking market." Launched in 2019, C6 Bank has amassed more than 7 million customers on its digital platform.
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ALC | Hot Stocks12:04 EDT Alcon appoints Ian Bell as president, global business & innovation - Alcon announced changes to its Executive Committee of Alcon. Changes take effect September 1, 2021. Ian Bell, currently President, International, and a member of the ECA, is named President, Global Business & Innovation. Michael Onuscheck, current President, Global Business & Innovation, and a member of the ECA, will be stepping down from his roles at the Company. Raj Narayanan, Senior Vice President, Operational Strategy and Chief Transformation Officer, and a member of the ECA, will succeed Ian Bell as President, International. Sue-Jean Lin, Senior Vice President & Chief Information Officer, will be appointed as Senior Vice President, Chief Information & Transformation Officer and will add oversight of Alcon's Transformation program to her remit. She will also become a member of the ECA. The ECA will remain with seven committee members and effective September 1, will be comprised of the following members: David Endicott, Laurent Attias, Ian Bell, Sergio Duplan, Sue-Jean Lin, Raj Narayanan, and Tim Stonesifer.
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CNI KSU | Hot Stocks12:04 EDT CN-KCS voting trust receives additional support from unions - CN (CNI) and Kansas City Southern (KSU) announced that three local union committees representing CN and KCS employees in the United States that are affiliated with the Brotherhood of Locomotive Engineers and Trainmen have filed four letters in support of the proposed voting trust with the Surface Transportation Board. These letters were filed as part of the STB's public comment period for its review of the CN-KCS voting trust, which will close at midnight today. These letters underscore the significant benefits for organized labor from a CN-KCS combination. These local BLET committees represent CN employees in locations from the Canadian border to the Gulf of Mexico who have a direct interest in the proposed pro-competitive CN-KCS combination. The letters express support for CN's and KCS' voting trust from officers including the General Chairmen of BLET General Committees of Adjustment 360, 390 and 910, which collectively represent more than 1,700 locomotive engineers on CN's United States rail operating subsidiaries and approximately 200 engineers working on KCS.
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BNED | Hot Stocks12:01 EDT Barnes & Noble Education announces ten-year partnership with Notre Dame - Barnes & Noble Education announced it has entered into a ten-year partnership with the University of Notre Dame under which Barnes & Noble College will manage all course materials, retail, and online operations for the University's campus retail stores. "BNC, through its strategic alliance with online and offline licensed sports merchandise leaders Fanatics and Lids, will deliver an exceptional retail experience to the Notre Dame community with a reimagined consumer-centric platform to elevate engagement with students, faculty, alumni, family, friends and fans," the company stated.
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NEX | Hot Stocks12:00 EDT NexTier Oilfield falls -9.6% - NexTier Oilfield is down -9.6%, or -51c to $4.83.
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YMM | Hot Stocks12:00 EDT Full Truck Alliance falls -10.0% - Full Truck Alliance is down -10.0%, or -$1.98 to $17.75.
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BBW | Hot Stocks12:00 EDT Build-A-Bear falls -11.1% - Build-A-Bear is down -11.1%, or -$2.20 to $17.57.
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DQ | Hot Stocks12:00 EDT Daqo New Energy rises 13.5% - Daqo New Energy is up 13.5%, or $7.91 to $66.57.
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JKS | Hot Stocks12:00 EDT JinkoSolar rises 21.1% - JinkoSolar is up 21.1%, or $9.06 to $52.06.
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SNR | Hot Stocks12:00 EDT New Senior Investment rises 28.8% - New Senior Investment is up 28.8%, or $1.99 to $8.90.
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MO | Hot Stocks11:36 EDT Juul agrees to pay $40M to settle North Carolina vaping case - North Carolina Attorney General Josh Stein reached agreement on a consent order with e-cigarette maker JUUL, which is 35% owned by Altria, that will require JUUL to pay $40M and make drastic changes to the way it conducts business. Attorney General Stein began investigating JUUL in 2018 and sued the company in 2019 for designing, marketing, and selling its e-cigarettes to attract young people and for misrepresenting the potency and danger of nicotine in its products. JUUL is making the following commitments about its business practices enforceable in North Carolina court in order to avoid appealing to young people: No marketing that appeals to people under the age of 21. No using most social media advertising, influencer advertising, outdoor advertising near schools, and sponsoring sporting events and concerts. No claims that compare the health effects of using JUUL with the health effects of using combustible cigarettes in its marketing materials. No online sales to anyone not age verified by an independent verification system and making sure third-party sales partners do the same. No retail sales to anyone not age verified using a barcode scanner. Ensure its products are sold behind counters so shoppers cannot access them without a shop employee's assistance. Maintain a retailer compliance secret shopper program in North Carolina to ensure these measures are followed and hold accountable retailers that fail. No new flavors or nicotine content levels without FDA authorization. Further, JUUL will pay $40M to the state over the next six years. That money will fund programs to help people quit e-cigarettes, prevent e-cigarette addiction, and research e-cigarettes. Reference Link
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MMS | Hot Stocks11:26 EDT MAXIMUS trading resumes
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MMS | Hot Stocks11:12 EDT Maximus aware of 'incorrect reporting' regarding business bearing similar name - Maximus (MMS), a provider of government services, announced that it is "aware of incorrect reporting circulating among certain news outlets." The company stated: "Maximus, Inc., a Virginia corporation with the ticker symbol MMS, has been mistaken for a privately-held Canadian firm in the agriculture technology business bearing a similar name. Earlier today, Ingersoll Rand (IR) announced an agreement to acquire the Canadian firm."
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AEP | Hot Stocks11:02 EDT SWEPCO issues requests for proposals for purchase of wind, solar - Southwestern Electric Power, or SWEPCO, a subsidiary of American Electric Power, issued three Requests for Proposals for renewable and short-term generating capacity to supply the needs of its customers. The RFPs solicit bids for the purchase of wind resources of up to 3,000 megawatts; solar resources up to 300 MW and short-term accredited deliverable capacity up to 250 MW. Proposals are due by Aug. 12, 2021.
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BTC... | Hot Stocks11:00 EDT UK regulator bans crypto exchange Binance - In a Saturday consumer warning, the UK's Financial Conduct Authority said, "Binance Markets Limited is not permitted to undertake any regulated activity in the UK. This firm is part of a wider Group. Due to the imposition of requirements by the FCA, Binance Markets Limited is not currently permitted to undertake any regulated activities without the prior written consent of the FCA. No other entity in the Binance Group holds any form of UK authorisation, registration or licence to conduct regulated activity in the UK. The Binance Group appear to be offering UK customers a range of products and services via a website, Binance.com." Reference Link
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SABR | Hot Stocks10:54 EDT SCAT Airlines signs up for Sabre's passenger reservations system - SCAT Airlines and Sabre announced a new strategic partnership, building on Sabre's other achievements in the central Asian region. Under the new agreement, SCAT Airlines will migrate to Sabre's passenger reservations system, SabreSonic. It will also leverage Sabre's industry-first Commercial Platform to create a differentiated brand experience for travelers while also helping the airline to maximize revenue. By delivering real-time, customer-centric offers to the airline's customers, Sabre's technology will help SCAT achieve its ambitious plans to lead the recovery and future growth of travel in Kazakhstan.
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RNSDF | Hot Stocks10:52 EDT Renault signs EV battery deals with Envision, Verkor - Renault Group announces its strategy for EV battery design and production in France. A major milestone of the 'Renaulution' road map, the Group's battery strategy comes to life through the signing of two major partnerships: with Envision AESC and Verkor. These two most recent partnerships go hand in hand with existing programmes within Renault Group, in particular the historic agreement with LG Chem which currently supplies battery modules for Renault's electric range and for the upcoming MeganE. In parallel, there are on-going discussions with ACC to potentially join the ecosystem as of 2027. Research also continues within the Alliance to deploy solid battery technology from 2030, with the ASSB project. As part of its EV strategy, Renault Group is partnering with Envision AESC which will develop a gigafactory in Douai with a capacity of 9 GWh in 2024 and with aim of reaching 24 GWh by 2030. As the battery arm of global green tech company Envision Group, it will invest up to EUR 2 billion to produce latest technology, cost-competitive, low-carbon and safe batteries for electric models, including the future R5. Thanks to this partnership, Envision AESC forecasts 2,500 new jobs by 2030. The proximity of the Envision AESC's gigafactory to Renault ElectriCity production sites at Douai, Maubeuge and Ruitz, which will create 700 additional jobs in the Hauts-de-France region, means Renault Group can significantly boost its competitive edge and greatly improve the efficiency of its EV production chain. Douai's gigafactory opens the way for the production of low-carbon batteries as part of the objectives outlined in the European Green Deal and for the development of closed-loop recycling solutions for production waste and end-of-life batteries. In line with commitments made by the Renault Group, it will significantly contribute to achieving carbon neutrality in Europe by 2040 and worldwide by 2050, with EV sales making up 90% of all Renault brand sales by 2030. In addition to its partnership with Envision AESC, Renault Group has signed a Memorandum of Understanding to become shareholder of Verkor with a stake of over 20% in the company and plans to join the consortium that was created around the French start-up in 2020. The consortium aims at tackling challenges relating to digitalisation, de-carbonisation, and the strengthening the French and European industries within the sector. Renault Group and Verkor intend to develop jointly a high-performance battery suitable for the C and higher segments of the Renault range, as well as for the Alpine models. Together with the consortium, they will help create of more than 200 direct jobs. The initial phases of the partnership will involve the financing of a R&D centre and a pilot line for battery cell and module prototyping and production in France as early as 2022. The second phase will see Verkor moving forward to create the first gigafactory for high performance batteries in France, with an initial capacity of 10 GWh for the Renault Group from 2026, potentially rising to 20 GWh by 2030. Cooperation between Renault Group and Verkor will be based on a common road map to reduce carbon emissions from battery manufacturing by 75% compared to traditional process, and to establish a supply chain that allows traceability and secures the availability of raw materials used in EV models. Reference Link
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MMS | Hot Stocks10:50 EDT MAXIMUS trading halted, news pending
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HMC | Hot Stocks10:31 EDT Honda's electric SUV Prologue to come to market in 2024 - Honda announced that its first new volume battery-electric vehicle will be named "Prologue," signaling a new electrified era that will lead to the company's vision for 100% zero emission vehicle sales in North America by 2040. An all-new SUV coming to market in early 2024, the battery-electric Honda Prologue will be highly competitive with the functionality expected by Honda customers. More specific details about the new vehicle will be released over the coming months, and Honda will engage with prospective EV customers throughout the launch. In addition to the Honda Prologue, the company will introduce an all-electric Acura SUV in the 2024 calendar year. Both will utilize the highly flexible global EV platform powered by Ultium batteries based on the company's strategic partnership with General Motors. Honda also plans to launch a new series of EV models in the second half of the decade based on a new e:Architecture, with development led by Honda. Reference Link
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COIN | Hot Stocks10:20 EDT BaFin grants first permission to conduct crypto custody business to Coinbase - BaFin, the Federal Financial Supervisory Authority, has granted permission on June 28 to Coinbase Germany GmbH to conduct a crypto custody business, according to a translation of a German-language notice posted by the financial regulatory authority for Germany. "Coinbase Germany GmbH is therefore the owner of the first license issued by BaFin for the crypto custody business that was newly introduced as a financial service. Since this is a novel business model, shortly after the law implementing the amendment to the fourth EU Money Laundering Directive came into force, BaFin put together an interdisciplinary, cross-divisional and cross-departmental team to deal with the complex issues relating to crypto custody business," the translated notice states. Reference Link
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MDWD | Hot Stocks10:14 EDT MediWound partner says new drug application for KMW-1 submitted in Japan - Kaken Pharmaceutical announced earlier that it has submitted a new drug application to Japan's Ministry of Health, Labour and Welfare to seek manufacturing and marketing approval of KMW-1 for the removal of burn eschar. In April 2016, Kaken entered into an exclusive licensing agreement with MediWound and has developed KMW-1, which is available in certain countries under the brand name NexoBrid. "The Phase 3 clinical trial in Japan, which enrolled patients with deep partial and full-thickness burn, has demonstrated a favorable efficacy and safety profile. If KMW-1 is approved, it would provide a new treatment option for burn patients by enabling non-invasive removal of eschar," Kaken stated. Reference Link
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BAESY LMT | Hot Stocks10:02 EDT BAE Systems ramps F-35 electronic warfare system production - BAE Systems announced it (BAESY) is providing Lockheed Martin (LMT) with additional electronic warfare systems, retrofit kits, and spares for the F-35 Lightning II aircraft. "The contract builds on BAE Systems' on-time delivery of more than 800 state-of-the-art AN/ASQ-239 electronic warfare/countermeasure systems to date, providing F-35 jets with critical situational awareness and survivability capabilities... This Lot 16 award comes as BAE Systems delivers Lot 14 systems and executes material orders for Lot 15. The company is currently producing 18 shipsets a month as it ramps production to more than 20 shipsets a month in 2022 to match F-35 aircraft Low Rate Initial Production," the company stated.
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TK | Hot Stocks10:00 EDT Teekay Corp. falls -6.4% - Teekay Corp. is down -6.4%, or -26c to $3.79.
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NVRO | Hot Stocks10:00 EDT Nevro falls -6.5% - Nevro is down -6.5%, or -$11.61 to $166.98.
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YMM | Hot Stocks10:00 EDT Full Truck Alliance falls -8.6% - Full Truck Alliance is down -8.6%, or -$1.70 to $18.03.
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JKS | Hot Stocks10:00 EDT JinkoSolar rises 8.4% - JinkoSolar is up 8.4%, or $3.63 to $46.63.
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XYF | Hot Stocks10:00 EDT X Financial rises 17.1% - X Financial is up 17.1%, or $2.57 to $17.63.
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SNR | Hot Stocks10:00 EDT New Senior Investment rises 26.8% - New Senior Investment is up 26.8%, or $1.85 to $8.76.
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MFC | Hot Stocks09:53 EDT Manulife Investment Management acquires TriVista on Speer for $144.5M - Manulife Investment Management announced it has acquired TriVista on Speer, a multifamily property in Denver, Colorado for $144.5M on behalf of a third-party managed account. TriVista on Speer is a recently completed class A, 322-unit, seven story, multifamily property located at 1350 Speer Boulevard in the premier Golden Triangle neighborhood of Denver. The building features large floorplans with average unit sizes of 985 square feet, which includes an attractive mix of one studio unit, 179 one-bedroom units, 94 two-bedroom units, and 4 three-bedroom units. The 317,015 square foot property also offers high-end amenities catering to the demands of the young working professional such as a rooftop lounge, pool deck, conference rooms, and multi-floor fitness center. It is currently over 90% occupied.
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RECAF | Hot Stocks09:50 EDT Reconnaissance Energy Africa calls short seller's report 'biased' - Reconnaissance Energy Africa said the company is providing "the real facts in response to falsehoods and distortions from a recent short seller's report. The short seller report published on June 24, 2021 which falsely claims that no petroleum exists in the Kavango Basin completely ignores prominent geoscientists with decades of international experience, who have all verified that ReconAfrica's data clearly confirms a working petroleum system. The short seller has no geological expertise itself, has not seen any data whatsoever, and its financial bias is clear: it admits that it has shorted the stock of ReconAfrica. ...The portion of the short seller's report that addresses the topics described above is riddled with inaccuracies. It displays an ignorance of the geology of Southern Africa in general and Namibia in particular. The results of the 6-2 and 6-1 stratigraphic test wells are misrepresented by the short seller, suggesting there is 'no oil', when in fact results from both wells were much more successful than anticipated, and firmly prove the presence of a working petroleum system. It overstates seismic acquisition costs by over 500%. It has misrepresented the relinquishment provisions of the Petroleum Agreement. Incredibly, it suggests that ReconAfrica is nearly bankrupt, when in fact ReconAfrica has over CDN $63,000,000 of cash reserves, access to additional funds through capital markets and joint venture optionality to pursue its operations. The short seller either lacks the knowledge and experience to assess these matters, or is intentionally distorting the publicly disclosed facts, or both. The short seller report is littered with falsehoods on a variety of other topics. For the most part these are repetitions from earlier publications that ReconAfrica has previously addressed and debunked. We reemphasize what has been stated previously: ReconAfrica directors and officers have consistently been net buyers of ReconAfrica stock. In the past 12 months, according to SEDI.ca, current officers and directors of ReconAfrica have purchased 985,289 shares for a cost of CDN $793,428 and have only sold 112,206 shares for gross proceeds of CDN $744,661, retaining 4,383,289 shares with a current market value of over CDN $48 million. Companies operating any sort of "pump and dump" scheme would surely have sold significantly more shares than the officers and directors of ReconAfrica where the Company's stock has risen 1326% in the past 12 months. Clearly, directors and officers of ReconAfrica are committed to the long term viability and success of the Company. Despite the actions of short sellers and their enablers, ReconAfrica and our joint venture partner NAMCOR, will proceed with our plans to explore for this potentially major energy source for Namibia and Botswana in the Kavango area, in an environmentally and socially respectful manner and for the benefit of all."
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DFPH | Hot Stocks09:50 EDT DFP Healthcare Acquisitions Corporation (Class A Stock) trading resumes
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YMM | Hot Stocks09:47 EDT Full Truck Alliance falls -5.7% - Full Truck Alliance is down -5.7%, or -$1.13 to $18.60.
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SAND | Hot Stocks09:47 EDT Sandstorm Gold falls -6.1% - Sandstorm Gold is down -6.1%, or -49c to $7.59.
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NVRO | Hot Stocks09:47 EDT Nevro falls -7.1% - Nevro is down -7.1%, or -$12.61 to $165.98.
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PSFE | Hot Stocks09:47 EDT Paysafe rises 8.1% - Paysafe is up 8.1%, or 98c to $13.20.
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BODY | Hot Stocks09:47 EDT Beachbody Company rises 10.7% - Beachbody Company is up 10.7%, or $1.28 to $13.28.
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SNR | Hot Stocks09:47 EDT New Senior Investment rises 24.3% - New Senior Investment is up 24.3%, or $1.68 to $8.59.
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AZN | Hot Stocks09:35 EDT AstraZeneca says Vaxzevria induced immunity for at least year following one dose - AstraZeneca announced that a sub-analysis from the Oxford-led COV001 and COV002 trials with Vaxzevria induced strong immune responses following either a prolonged second dose interval of up to 45 weeks or following a third boosting dose. The results, published by the University of Oxford on the pre-print server of The Lancet, demonstrated that antibody levels remain elevated from baseline for at least one year following a single dose. An extended interval between the first and second dose of Vaxzevria of up to 45 weeks, resulted in up to an 18 fold increase in antibody response, measured 28 days after the second dose. With a 45 week dosing interval between the first and second dose, antibody titres were four times higher than with a 12 week interval, demonstrating that a longer dosing interval is not detrimental but can derive stronger immunity. In addition, a third dose of Vaxzevria given at least 6 months after a second dose, boosted antibody levels six fold and maintained T cell response. A third dose also resulted in higher neutralising activity against the Alpha (B.1.1.7, 'Kent'), Beta (B.1.351, 'South African') and Delta (B.1.617.2, 'Indian') variants. Both the late second dose and the third dose of Vaxzevria were less reactogenic than the first dose. Professor Sir Andrew J Pollard, chief investigator and director of the Oxford Vaccine Group at the University of Oxford, said: "This should come as reassuring news to countries with lower supplies of the vaccine, who may be concerned about delays in providing second doses to their populations. There is an excellent response to a second dose, even after a 10 month delay from the first."
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CVM | Hot Stocks09:35 EDT Cel Sci trading resumes
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VRTX | Hot Stocks09:32 EDT Vertex in national reimbursement agreement in France for KAFTRIO - Vertex Pharmaceuticals announced a national reimbursement agreement with the French Health Authorities for the cystic fibrosis medicines KAFTRIOivacaftor /tezacaftor/elexacaftor in a combination regimen with ivacaftor and SYMKEVI tezacaftor/ivacaftor in combination with ivacaftor. Both medicines will be available for all eligible patients once the agreement has been published in the French Official Journal. "Today's announcement represents a major milestone for CF patients in France. Through this national reimbursement agreement, eligible patients 12 years and older now have access to KAFTRIO and SYMKEVI. For those living with CF, we are delighted to have reached this agreement so quickly and that the French Health Authorities have recognized the value of both medicines," said Ludovic Fenaux, Senior Vice President, Vertex International. The reimbursement agreement enables broad access to KAFTRIO for people with CF ages 12 years and older with one F508del mutation and one minimal function mutation. The triple combination therapy will also be reimbursed for patients who are homozygous for the F508del mutation in the CFTR gene, representing a new therapeutic option for treating physicians. In November 2020, the Transparency Commission of the French National Authority for Health granted KAFTRIO an ASMR 2 rating, which indicates "a significant improvement in medical service rendered." Of the 250 first-time listing medicines issued in 2019 by the TC, only two received such a rating. Under the terms of the new reimbursement agreement, SYMKEVI will be reimbursed for people with CF ages 12 years and older with one F508del mutation and one of the mutations resulting in residual activity of the CFTR protein as listed in the Summary of Product Characteristics. It will also be funded for patients who are homozygous for the F508del mutation in the CFTR gene.
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GCMG KKR | Hot Stocks09:31 EDT GCM Grosvenor announces creation of GCM Grosvenor Insurance Solutions - GCM Grosvenor (GCMG) announced that it will form GCM Grosvenor Insurance Solutions to provide alternative investment solutions to insurance company balance sheets globally. In addition, the firm announced that John Morrison will join to become head of GCM Grosvenor Insurance Solutions. John brings over 20 years of experience in financial services and as a strategic advisor to insurance clients, most recently as a Managing Director at Kohlberg Kravis Roberts & Co. (KKR) where he was co-head of KKR's insurance company business development and solutions efforts.
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SPCB | Hot Stocks09:29 EDT SuperCom awarded $3.6M project in Finland - SuperCom was awarded a $3.6M project with the national government of Finland to deploy its PureSecurity Electronic Monitoring Suite. Through its innovative and proven technology and services, SuperCom's aims to help Finland improve public safety efficacy as well as reduce prison overcrowding and lower recidivism. The nationwide project is set to cover all electronic monitoring offender programs within the country and expected to include at least 1,000 enrollees simultaneously for a duration of 4 years, with potential for extensions. The project will include the following PureSecurity offerings: Prison inmate monitoring, GPS tracking of offenders, RF monitoring for house arrest, and officer and offender mobile solutions. This deployment is planned to integrate traditional EM with inmate monitoring in a seamless way, providing continuous tracking of offenders while they are in prison and as they are away from the facilities during short-term releases.
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CVM | Hot Stocks09:27 EDT CEL-SCI announces 9.5 year data indicating OS benefit in Multikine patient group - CEL-SCI announced results from its 9.5 year pivotal Phase 3 study for its immunotherapy Multikine in the treatment of advanced primary squamous cell carcinoma of the head and neck, or SCCHN. In the intent to treat, or ITT, advanced primary SCCHN patients the study showed a statistically significant overall survival benefit of 14.1% with overall survival, or OS, of 62.7% at five years for the group of patients receiving the Multikine treatment regimen followed by surgery and radiotherapy therapy, but not chemotherapy, as part of their standard of care, or SOC, treatment. The OS benefit increased over time. This group represents about 155,000 patients worldwide, or about 40% of all advanced primary head and neck cancer cases annually. Patients treated with the same Multikine treatment regimen prior to surgery and radiotherapy, but who also received chemotherapy, did not exhibit this survival advantage. The chemotherapy, cisplatin, was given intravenously and may have negated the survival benefit imparted by Multikine immunotherapy in these patients. This global trial enrolled 928 stage III and IVa patients through 78 sites on 3 continents. The ITT population comprised of 923 patients, as 5 randomized patients were never treated. The two main comparator arms of the study were: the Multikine treatment regimen plus SOC vs. SOC alone. In each of these comparator arms, patients were determined by pathology following surgery to receive radiotherapy only or concurrent radio-chemotherapy. These treatments were prescribed by the protocol and are based on the NCCN Guidelines for the treatment of SCCHN patients. The data were analyzed per the protocol and the Statistical Analysis Plan. Results for the patients who did not receive chemotherapy treatment as part of their SOC are listed below. This is the group for which CEL-SCI plans to seek FDA approval: Patients treated with the Multikine treatment regimen plus SOC vs. SOC alone had an overall survival benefit of 14.1% at 5 years which exceeded the pre-defined 10% overall survival benefit set out for the study population as a whole. This result was statistically significant with a durable duration effect exceeding five years. The corresponding overall survival at three years and five years for each study treatment group was as follows: Multikine treatment regimen plus SOC was 72.4% at three years, 62.7% at five years; Multikine plus SOC was 78.8% at three years, 55.5% at five years. SOC alone was 67.5% at three years, 48.6% at five years. The primary survival comparison was pre-defined only between the first and last groups. The OS advantage increased over time and was evident from the inception of the study participation for this group of patients through the end of the follow up period with a median follow up time greater than seven years for those still alive. No safety issues for Multikine were found during or as a result of its administration, including no late effects, in the overall treated patient population. When the complete study population to which the Multikine treatment regimen was administered and higher risk was compared to control, the study did not achieve its primary endpoint of a 10% improvement in overall survival. However, the OS benefit of 14.1% at five years for the lower risk subgroup exceeded the 10% OS benefit set out for the study population as a whole. In addition, as the OS results for the lower risk of recurrence patients are significant and the effect is robust, durable and increasing over time, CEL-SCI plans to seek FDA approval for Multikine cancer immunotherapy in this underserved patient population. This indication represents a dire unmet medical need with the last FDA approval being many decades ago. CEL-SCI has Orphan Drug designation from the FDA for the neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck - the patient population treated in this Phase 3 study. The analysis of this separate group is expected to meet regulatory requirements for FDA submission based on the protocol and Statistical Analysis Plan, which were prospectively concluded before database lock and unblinding.
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VIVO | Hot Stocks09:27 EDT Meridian Bioscience resubmits EUA apllication for Revogene assay - Meridian Bioscience announced that it has re-submitted its application for Emergency Use Authorization to the U.S. Food and Drug Administration for the company's SARS-CoV-2 molecular diagnostic test on the Revogene platform. On February 22, 2021, Meridian voluntarily withdrew its EUA application in order to conduct additional studies based on guidance from the FDA. Meridian completed the additional studies and re-submitted its EUA application on Friday, June 25, 2021.
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BIIB | Hot Stocks09:25 EDT House committees to investigate approval, pricing of Biogen Alzheimer's drug - Rep. Carolyn Maloney, Chairwoman of the Committee on Oversight and Reform, and Rep. Frank Pallone, Chairman of the Committee on Energy and Commerce, issued a statement Friday announcing the Committees will examine the approval and pricing of Biogen's (BIIB) Alzheimer's drug, Aduhelm. "We have serious concerns about the steep price of Biogen's new Alzheimer's drug Aduhelm and the process that led to its approval despite questions about the drug's clinical benefit. We strongly support innovative treatments to help the millions of Americans who suffer from Alzheimer's disease, but Aduhelm's approval and its $56,000 annual price tag will have broader implications for seniors, providers, and taxpayers that warrant close examination. Our Committees will be investigating this matter so Congress and the American people can better understand why this drug was approved, how Biogen set its price and what impact this will have on research for future Alzheimer's treatments and federal health care programs," they said. Shares of Biogen in premarket trading are down 1% to $343.11. Reference Link
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AMC | Hot Stocks09:24 EDT AMC reports more than 2M U.S. guests in 'post-reopening record weekend' - AMC Theatres announced that audiences "came roaring back to AMC movie theatres in post-reopening record numbers this weekend" and it credits the opening of "F9: THE FAST SAGA," as well as other movies also currently playing at its theatres, to AMC seeing its "busiest weekend attendance numbers in more than a year." AMC said: "Some 2 million people watched movies at AMC's United States theatre locations between Thursday, June 24 and Sunday, June 27. These are the biggest numbers recorded by AMC in the U.S. since closing its theaters in March of 2020 due to the coronavirus pandemic. 'F9: THE FAST SAGA' opened to an estimated $70 million for its opening weekend in the United States, shattering the previous post-reopening record. In fact, the $70 million is the biggest opening weekend for any movie in the U.S. since late in 2019. As the largest theatrical exhibitor in the United States, it's no surprise that AMC enjoyed its busiest weekend in more than a year. Six of the top 10 busiest theatres in the U.S. across the whole movie theatre industry were AMCs. They were led by the AMC Burbank complex and Universal Cinema AMC at CityWalk Hollywood, which also were the top two movie theatre locations in the entire country. More than 500,000 additional people visited AMC's international theatres in Europe and the Middle East, also a post-reopening record, bringing the total global attendance at AMC's theatres at home and abroad this past weekend to an encouraging 2.5 million." Adam Aron, CEO & President of AMC Theatres, added, The combination of widespread vaccination and the release once again of blockbuster movies is proving to be the magic formula for the return of moviegoing. We could not be more excited about this post-reopening record weekend, and the coming slate of what look to be more blockbuster movies being released this summer and beyond."
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RNVA | Hot Stocks09:21 EDT Rennova Health closes agreement with VisualMED Clinical Solutions - Rennova Health confirms it has closed the agreement with VisualMED Clinical Solutions, a Nevada based public company, to merge its software and genetic testing interpretation divisions, Health Technology Solutions and Advanced Molecular Services Group and their subsidiaries into VisualMED. These entities will operate as wholly owned subsidiaries of VisualMED which will immediately take the steps required to complete a name and trading symbol change. VisualMED intends to complete the required filings to become compliant with SEC reporting requirements to become a fully reporting company as soon as practical. Rennova and VisualMed intend to take the necessary steps to comply with the relevant regulations and rules to permit Rennova to distribute shares in VisualMED to its shareholders at some time in the future.
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MYMMF IMCC | Hot Stocks09:20 EDT ISS, Glass Lewis recommend MYM shareholders vote for IM Cannabis acquistion - MYM Nutraceuticals (MYMMF) announced that both Glass, Lewis & Co. and Institutional Shareholder Services have each issued positive reviews of the proposed acquisition of MYM by IM Cannabis Corp. (IMCC) announced on April 1, 2021. Both Glass Lewis and ISS recommend that MYM shareholders vote in favour of the resolution to be voted on at the special meeting of shareholders to be held on July 5, 2021. A total of 66 & 2/3rds of all common shares voted are required to approve the Transaction as well as a majority of the minority vote in accordance with Multilateral Instrument 61-101 Protection of Minority Security Holders in Special Transactions. To date, including those who have entered into support agreements, over 90% of overall committed and tallied common shares are being voted in favour of the Transaction. The votes attached to the common shares owned by Michael Wiener, CEO, Laird Choi, VP, Human Resources and Corporate Services and Robert Wolf, Independent Director will be excluded for purposes of the Transaction approval required by MI 61-101.
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AMPG | Hot Stocks09:17 EDT AmpliTech Group joins Russell Microcap Index - AmpliTech Group announced it has been added to the Russell Microcap Index in conjunction with the Index's annual reconstitution, which took effect after the market's close on June 25th.
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CSSE | Hot Stocks09:17 EDT Chicken Soup for the Soul to launch services on FreeCast's SelectTV - Chicken Soup for the Soul Entertainment announced the agreement to launch Crackle Spotlight, Crackle Classics, Popcornflix, and Truli linear channels on FreeCast's SelectTV service. Crackle Plus will also make VOD content from its Crackle and Popcornflix libraries available on SelectTV.
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CVM | Hot Stocks09:16 EDT Cel Sci trading halted, news pending
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SVBL | Hot Stocks09:15 EDT Silver Bull closes private placement for proceeds of C$500,000 - Silver Bull Resources is pleased to announce the completion a of a private placement of 500,000 shares of common stock of the Company at a price of C$1.00 per Share for gross proceeds of C$500,000. No placement agent or finder's fees were paid in connection with the Private Placement, and the net proceeds of the Private Placement will be used by Silver Bull for general working capital purposes. The Company also announces that Olympia Trust Company has replaced Equiniti Trust Company and TSX Trust Company as the registrar and transfer agent of the Company. Shareholders need not take action in respect of the change in transfer agent.
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VTR SNR | Hot Stocks09:15 EDT Ventas to acquire New Senior in all equity $2.3B transaction - Ventas (VTR) and New Senior Investment Group (SNR) announced that they have entered into a definitive merger agreement pursuant to which Ventas will acquire New Senior in an all-stock transaction valued at approximately $2.3B including $1.5B of New Senior debt. Under the terms of the agreement, New Senior shareholders will receive 0.1561 shares of newly issued Ventas stock per share of New Senior common stock. Based on the closing price of Ventas common stock on June 25, 2021, this represents approximately $9.10 per New Senior share, a 31% equity premium based on New Senior's 30-day trading average, and a 10% premium on New Senior's total enterprise value. "Building on the strong momentum we are experiencing in our business, we are delighted to announce this strategic and accretive acquisition with New Senior that expands Ventas's position in senior housing at an important inflection point in the cycle as the senior housing industry rebounds," said Debra A. Cafaro, Ventas Chairman and CEO.
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VTR | Hot Stocks09:11 EDT Ventas to acquire New Senior in $2.3B all equity transaction - Ventas (VTR) and New Senior Investment Group (SNR) announced that they have entered into a definitive merger agreement pursuant to which Ventas will acquire New Senior in an all-stock transaction valued at approximately $2.3B, including $1.5B of New Senior debt. New Senior has a high-quality, geographically diversified portfolio of 103 private pay senior living communities, including 102 independent living communities, totaling 12,404 units and located across 36 states in the United States. Under the terms of the agreement, New Senior shareholders will receive 0.1561 shares of newly issued Ventas stock per share of New Senior common stock. Based on the closing price of Ventas common stock on June 25, 2021, this represents approximately $9.10 per New Senior share, a 31% equity premium based on New Senior's 30-day trading average, and a 10% premium on New Senior's total enterprise value. The Transaction valuation is expected to represent approximately a 6% capitalization rate on expected New Senior 2022 Net Operating Income and is expected to be approximately $0.09 to $0.11 accretive to Ventas's normalized funds from operations per share on a full year basis. "Building on the strong momentum we are experiencing in our business, we are delighted to announce this strategic and accretive acquisition with New Senior that expands Ventas's position in senior housing at an important inflection point in the cycle as the senior housing industry rebounds," said Debra A. Cafaro, Ventas Chairman and CEO.
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AVCO | Hot Stocks09:10 EDT Avalon GloboCare CEO issues shareholder letter on SenlangBio acquisition - Avalon GloboCare provided the following letter to shareholders from its President and CEO David Jin: "We recently entered into a definitive purchase agreement to acquire SenlangBio, a world-class cell therapy company. We believe that the acquisition, which is subject to certain previously disclosed closing conditions, will significantly enhance Avalon's capabilities in cell and gene therapy, expanding our therapeutic pipeline by adding 15 autologous and universal cell therapy programs. SenlangBio has applied its cellular therapeutics technology to develop a broad range of cellular therapy candidates including CAR-T, CAR-gammadeltaT and armored tumor infiltrating lymphocytes, with potential applications to a wide array of hematologic malignancies and solid tumors. This transformative acquisition will significantly contribute to sustainable and successful growth and development of Avalon. Importantly, this will be an all-stock transaction, which clearly illustrates the confidence and commitment of SenlangBio and its principals. Avalon was also able to secure approximately $30M from an institutional healthcare investor for an approximately 13.5% equity interest in SenlangBio on favorable terms and without warrants or other equity-linked or debt instrument related to the financing. This funding, which is contingent on the close of the SenlangBio acquisition, should provide us with a substantial cash runway at SenlangBio for several years, as we advance a number of clinical programs and execute on key milestones. In connection with the acquisition, we intend to integrate Avalon's and SenlangBio's technology platforms and manufacturing/bio-processing infrastructure, which is expected to significantly reduce costs and accelerate the clinical translation of cellular technologies. To date, over 300 patients have received one of SenlangBio's 15 cell therapy candidates through investigator-initiated first-in-human clinical trials at 13 partnering hospitals, covering 9 indications with significant unmet medical needs. Importantly, SenlangBio's clinical trials have thus far demonstrated meaningful clinical benefit and favorable safety profiles among patients with solid tumors and hematological malignancies. SenlangBio's intellectual property includes 10 issued patents and 5 patents pending, as well as additional IP and trade secrets. Notably, SenlangBio will bring added capabilities to Avalon with their 16,000 square-foot GMP facility, which supports in-house bio-manufacturing, bio-processing, and QA/QC processes. Furthermore, SenlangBio has a revenue generating clinical laboratory that provides third-party clinical testing services including: general biochemical, genomic and proteomic testing; as well as cell therapy related testing such as hematology, immunology, cancer biomarkers, immuno-phenotyping, and more. For the year ended December 31, 2020 and the three months ended March 31, 2021, SenlangBio generated revenue of $1.1M and $1.2M, respectively, and had a net loss of $2.4M and $135,000, respectively. As a vertically integrated leader in cellular medicine with a strong technology platform that we believe can rapidly deliver life-saving cellular therapeutics to patients, I could not be more excited about the operational and financial outlook for our business. I strongly believe we will be well positioned to execute on our organic growth strategy and drive significant value for shareholders in the years ahead."
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DFPH TOI | Hot Stocks09:10 EDT The Oncology Institute to go public in DFP Healthcare Acquisitions combination - DFP Healthcare Acquisitions Corp (DFPH), a special purpose acquisition company sponsored by an affiliate of Deerfield Management, announced that it has entered into a definitive agreement for a business combination with The Oncology Institute, or TOI. Following the business combination, DFP expects to be renamed The Oncology Institute and will remain listed on the Nasdaq stock market under new ticker symbol (TOI). The transaction values the combined company at a pro forma enterprise value of approximately $842M and implies a multiple of 2.4x estimated 2022 revenue. The current equity holders of The Oncology Institute will be entitled to receive an additional earn out payment of up to 12.5M shares of The Oncology Institute common stock. In addition to the approximately $230M held in the DFP Trust Account, healthcare investors have committed to purchase $275M of shares of common stock of the company at $10.00 per share through a private placement in public entity, or PIPE. Assuming no redemptions of DFP public shares, the current equity holders of The Oncology Institute will collectively own 48%, Deerfield will own approximately 14%, other DFP stockholders will own 33%, and DFP's sponsor will own 5% respectively of the approximately 106M issued and outstanding shares of common stock of The Oncology Institute immediately following the closing. DFP estimates that, assuming no redemptions of DFP shares, the company will have an initial market capitalization of approximately $1.06B, with approximately $225M of cash on the balance sheet and a growth trajectory. The Oncology Institute expects to use this capital to accelerate its de novo and acquisition-driven growth initiatives. The business combination, which has been approved by the board of directors of DFP and The Oncology Institute, is expected to close in Q3 or Q4 of 2021, subject to customary conditions, including the approval by DFP stockholders.
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MDT | Hot Stocks09:08 EDT Medtronic presents InPen real-world data - Medtronic announced key clinical data from the virtual 81st annual American Diabetes Association Scientific Sessions. The presentations illustrated increases in Time in Range when using an InPen smart insulin pen, safety of an extended-wear infusion set that lasts up to 7 days, and patient satisfaction with the longer-wear infusion set. Medtronic presented real-world clinical results that compared glycemic outcomes for 1,736 individuals before and after using the InPen smart1 insulin pen for 90 days with a glucose monitor. Data showed an increase in Time in Range of 2.3% for people whose glucose management indicator was greater than8% and an increase of 5% Time in Range for people whose GMI was greater than9.5%. In both groups, people did not experience any increase in Time Below Range during the study period. Using InPen smart insulin pen also provided improved insulin dosing decision support for those in the study as demonstrated by fewer total doses per day with simultaneously improved glycemic control. The average daily insulin bolus frequency decreased (from 3.7 to 3.6/day and 3.3 to 3.2/day, respectively, for each group) and total rapid acting daily dose of insulin increased (from 26.29 to 27.19 u/day and 27.57 to 29.24 u/day, respectively, for each group). This real-world performance analysis aggregates information from individuals who uploaded their data from January 2018 to October 2020. A minimum of 30 days of CGM data pre- and post-InPen start were required to be part of the analysis.
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VZ... | Hot Stocks09:08 EDT Verizon Visa Card implements new travel, gift card rewards - The companies said, "Verizon (VZ) Visa (V) Card, issued by Synchrony (SYF), is the only credit card that lets customers earn Verizon Dollars, which can be redeemed for Verizon's best phones, 5G tech and even used to lower their monthly wireless bill. Now, those rewards get even better: card holders can redeem their rewards on even more of what they love, outside of Verizon- like gift cards from favorite brands, hotels, flights and car rentals. With travel starting to open back up, that summer trip couldn't come at a better time. Verizon Visa Card holders also get two free days of TravelPass annually and are never charged foreign transaction fees when spending abroad. So, when it's time to go places, the TravelPass allows card holders to use domestic talk, text and data in more than 185 countries-on us. The perfect rewards for that long-awaited summer vacation!"
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LOTZ | Hot Stocks09:06 EDT CarLotz opens three new hubs across the U.S. - CarLotz announced it has opened three new hubs across the country. The hubs, located in Bakersfield, CA, Clearwater, FL, and Highland Park, IL, further expand the company's national footprint, bringing the total open hubs to date to 15.
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CAG | Hot Stocks09:06 EDT Conagra Brands accelerates transition to 100% cage-free eggs - Conagra Brands announced the company's plans to accelerate its transition to 100% cage-free eggs, converting 100% of its egg usage to cage-free by the end of fiscal year 2024, one year earlier than its original commitment to directly source 100% cage-free eggs by 2025.
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CPXWF | Hot Stocks09:05 EDT Capital Power joins Powering Past Coal Alliance - Capital Power announced it has joined the Powering Past Coal Alliance, a coalition of national and sub-national governments, businesses and organizations, co-chaired by the UK and Canadian governments, committed to advancing the transition away from traditional coal generation and accelerating the transition to clean energy. Capital Power's commitment to being net carbon neutral by 2050 is a key driver of its strategy as the Company advances its clean energy goals by investing in world-leading optimization, efficiency and emissions reduction solutions - helping Canada to meet its climate goals and providing reliable, affordable and sustainable electricity integral to Alberta's and Canada's energy future. As part of Capital Power's strategy to meet its mid-century net carbon neutral goal, the Company has announced a $1B initiative to transform its Genesee Generating Station to natural gas power generation, ending coal-fired generation in 2023, six years ahead of the legislated off-coal date. This initiative includes repowering Genesee Units 1 & 2 with best-in-class natural gas combined cycle technology, that will be hydrogen capable and carbon conversion-ready, and converting Genesee Unit 3 to natural gas, delivering increased capacity of 560 MW and 3.4 million tonnes of annual carbon emissions reductions. The Company is also investing in carbon capture, utilization and sequestration technologies onsite to pursue additional carbon emissions reductions, as well as investing in growing its wind and solar asset portfolio.
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VOXX SHCAY | Hot Stocks09:05 EDT VOXX unit enters joint venture with Sharp to acquire certain assets of Onkyo - VOXX International (VOXX) announced that its wholly-owned subsidiary, Premium Audio Company, and Sharp (SHCAY) have successfully entered into a joint venture to acquire certain assets of the audio/video business of Onkyo Home Entertainment. This follows the Asset Purchase Agreement signed by the parties as announced on June 3. The proposed transaction was approved by Onkyo shareholders at its Ordinary General Meeting of Shareholders held on June 25 and was previously approved by Onkyo's Board of Directors. The total purchase price for the transaction is $30.8M, plus the assumption of certain liabilities and future payment of commissions to Onkyo on certain product sales. Premium Audio Company will own approximately 75% and Sharp will own approximately 25% of the JV. Premium Audio Company will handle distribution worldwide and be responsible for all sales and marketing activities. Sharp, though its manufacturing facility in Malaysia, will be responsible for manufacturing. The acquisition will provide the JV with ownership of the brands, intellectual property, engineering, and manufacturing rights of the Onkyo and Integra brands. Further, VOXX International has entered into a new licensing agreement with Pioneer Corporation and per this licensing agreement, Premium Audio Company will market and sell the Pioneer and Pioneer Elite brands worldwide, excluding the Peoples Republic of China. Finalization of the transaction is subject to customary and regulatory closing conditions and is expected to be consummated on or before August 30.
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BWB | Hot Stocks09:04 EDT Bridgewater Bank welcomes Joseph Birkholz as Chief Risk Officer - Bridgewater Bank announced the addition of Joseph Birkholz to its team as Chief Risk Officer. Joseph joins Bridgewater with over 15 years' experience in various enterprise risk management capacities. Joseph most recently served as Senior Vice President of Risk Operations at TCF Bank where he led teams across operational risk, vendor risk and risk operations disciplines. In his new position at Bridgewater, Joseph will help the Bank mitigate key risks by leveraging his expertise in creating and formalizing risk frameworks, developing risk and control assessments, credit risk analytics and operational risk management. Joseph holds a B.S. in accounting from The College of St. Scholastica and an MBA from the University of St. Thomas.
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AMD | Hot Stocks09:03 EDT AMD showcases AMD EPYC processors, AMD Instinct accelerators - At this year's International Supercomputing 2021 digital event, AMD is showcasing momentum for its AMD EPYC processors and AMD Instinct accelerators across the High Performance Computing industry. The company also outlined updates to the ROCm open software platform and introduced the AMD Instinct Education and Research initiative. The latest Top500 list showcased the continued growth of AMD EPYC processors for HPC systems. AMD EPYC processors power nearly 5x more systems compared to the June 2020 list, and more than double the number of systems compared to November 2020. As well, AMD EPYC processors power half of the 58 new entries on the June 2021 list.
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SGBX | Hot Stocks09:03 EDT SG Blocks subsidiary acquires 10% interest in JDI-Cumberland Inlet - SG Blocks announced today that its development subsidiary, SGB Development, has acquired a 10% non-dilutable equity interest in JDI-Cumberland Inlet, a Georgia limited liability company, contributing $3M in capital to develop Cumberland Inlet, a 1,286 acre waterfront parcel in historic downtown St. Marys, Georgia. SG DevCorp in conjunction with Jacoby Development of Atlanta, Georgia expects to develop a mixed-use destination community. The closing on the 1,286 acre waterfront parcel is scheduled to occur prior to the end of Q2.
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SCWX | Hot Stocks09:02 EDT Secureworks appoints Tracey Mustacchio as CMO - Secureworks announced the appointment of Tracey Mustacchio as its new Chief Marketing Officer. "As CMO, Mustacchio is leading Secureworks' global growth and marketing strategies at a pivotal time for the Company, as it combines its years of security expertise with a new security analytics and operations platform to help organizations detect, investigate, and respond to advanced threats more quickly and effectively," the company said. Mustacchio reports to incoming Secureworks CEO Wendy Thomas. Prior to Secureworks, she was interim Chief Marketing Officer for Carbonite and Webroot, taking them through their successful acquisition by Opentext.
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DASH BYND | Hot Stocks09:02 EDT DoorDash, Beyond Meat partner on grilling kits - DoorDash (DASH) announced a partnership with Beyond Meat (BYND) to offer limited-edition, July 4th grilling kits to help customers host the ultimate BBQ featuring this summer's hottest grilling essential: the sizzling new Beyond Burger. The kits are available exclusively on DoorDash for on-demand delivery from DashMart, a new type of convenience store owned, operated, and curated by DoorDash. In addition to the Beyond Burger, the grilling kits offer a custom grilling mit, apron, grilling tools, a bottle opener and a recipe card with custom dishes. The new burger is crafted to look, cook and taste like beef while offering strong nutritional benefits-such as: 35% less fat, 35% less saturated fat, fewer calories and no cholesterol compared to an 80/20 ground beef burger patty-to bring the thrill of grilling plant-based meat to a backyard near you. Additional items-from snacks, beverages, ice cream and more-can be purchased on-demand from DashMart to complete the gathering.
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ASXC | Hot Stocks08:57 EDT Asensus Surgical says hospital in Bern, Switzerland to start Senhance surgery - Asensus Surgical announced Inselspital, University Hospital Bern, Switzerland has initiated its Senhance Surgical System program. This is the second of two new agreements with two hospitals in Europe thus far in 2021, as previously announced in our May 11 news release. "Inselspital University Hospital in Bern is the largest University hospital group in Switzerland," Anthony Fernando, Asensus Surgical President and CEO, says. "We are very pleased they have started surgery with Senhance this week.'' The University department of visceral surgery - Abdominal Center Inselspital department is implementing the digital Senhance platform in their daily surgical practice and will study its clinical utility over the coming months. Asensus Surgical's technology platform, Senhance Surgical System, is the first of its kind digital laparoscopic platform that leverages augmented intelligence to provide unmatched performance and patient outcomes through machine learning. Senhance goes beyond the typical surgical robotic systems, providing surgical assurance through haptic feedback, Eye-tracking camera control, and 3D visualization, and is the first platform to offer 3 mm instruments .
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QRHC | Hot Stocks08:55 EDT Quest Resource to join Russell Microcap Index - Quest Resource Holding announced that it was selected to join the Russell Microcap Index effective after the U.S. market opens today, June 28, 2021, when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes.
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DBGI | Hot Stocks08:54 EDT Digital Brands says Bailey 44 started shipping wholesale orders in May - Digital Brands said second quarter operating results are "still expected to be adversely impacted by those factors which impacted the first quarter operating results. However, the adverse impact will be lesser in the second quarter due to the Harper & Jones contribution, Bailey 44 wholesale shipments for May and June, and some inventory levels starting in late May for DSTLD." The company additionally said "Bailey 44 started shipping wholesale orders in May, which is the first time in fifteen months that Bailey 44 has shipped wholesale orders. Bailey 44 fall 2021 wholesale bookings are in-line with pre-pandemic revenue levels. DSTLD received a men's denim inventory shipment in May, with more men's denim inventory landing in July. DSTLD will receive women's denim inventory shipment in July. DSTLD will receive men's and women's tee shirt inventory shipment in July."
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VERX COUP | Hot Stocks08:52 EDT Vertex announces certified integration for Coupa BSM platform - Vertex (VERX) announced it is releasing Vertex Indirect Tax O Series for Coupa Software (COUP), a new Vertex-built and supported integration to the Coupa Business Spend Management platform.
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MEEC | Hot Stocks08:50 EDT Midwest Energy Emissions eliminates $2.6M of convertible debt - Midwest Energy Emissions announced that all holders of the Company's outstanding 2019 Convertible Promissory Notes have agreed to convert their Notes into ME2C Environmental shares. The Company indicated that between June 17 and June 23, 2021, a total of $2,550,000 outstanding principal, together with interest, has been voluntarily converted into shares of the Company's common stock. The Convertible Notes were issued in 2019 in the aggregate principal amount of $2,600,000. Previously, $50,000 of the principal was converted, leaving $2,550,000 outstanding until the conversion being announced today.
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IMXI | Hot Stocks08:50 EDT International Money Express secures new debt facility, refinances $88M term loan - International Money Express announced that it completed a refinancing of its existing secured debt by entering into a new secured $87.5 million term loan facility, a $150 million revolving credit facility and an uncommitted incremental facility, which may be utilized for additional term or revolving loans of up to $70 million. The new term loan facility has a principal balance of $87.5 million maturing in 2026. Loans under the new term loan facility bear a market interest rate equal to LIBOR plus 250 basis points up to 300 basis points depending on the Company's total leverage ratio. This new rate represents a significant reduction from the prior rate of LIBOR plus 450 basis points. The proceeds of the new term loan facility were used to repay the Company's existing term loan obligations. The Company also successfully increased the commitments under the revolving credit facility to $150 million, maturing in 2026. The new facility replaced the Company's existing $45 million revolving credit facility. Loans under the new revolving credit facility also bear interest at LIBOR plus 250 basis points up to 300 basis points depending on the Company's total leverage ratio, while the prior facility's rate was LIBOR plus 450 basis points
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BTCS | Hot Stocks08:49 EDT BTCS appoints Andrew Lee as Chief Financial Officer - BTCS announced the appointment of Andrew Lee as Chief Financial Officer. Lee was previously an Executive/Entrepreneur-in-Residence at Kylin Management, a multibillion-dollar Tiger Cub hedge fund.
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CLVR | Hot Stocks08:49 EDT Clever Leaves launches research initiative Project Change Lives - Clever Leaves Holdings announces Project Change Lives, a U.S. focused research initiative, whereby the Company has pledged to contribute up to $25,000,000 retail value of medical cannabis products to any eligible U.S. organization to help advance scientific research into the potential medical benefits of cannabinoids. By sponsoring Project Change Lives, Clever Leaves is offering to provide a historic amount of pharmaceutical-grade cannabis to leading research institutions in one of the most advanced pharmaceutical markets in the world. Clever Leaves is looking to supply up to 250,000 bottles of pharmaceutical-grade cannabis oils or approximately 5 tons of medical cannabis flower that will help research institutions develop new therapies. To eliminate an additional impediment to the advancement of scientific knowledge around cannabis, this research material will be provided at no cost to Clever Leaves' research partners. The Company will be partnering with Biopharmaceutical Research Company, a company which holds federal licenses for importing, analyzing and manufacturing controlled substances, as its importer of record. Clever Leaves plans to begin working with U.S. investigators immediately and initiate their efforts with a research study focused on the DNA sequencing of a variety of their cannabis cultivars.
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WNDW LPL | Hot Stocks08:48 EDT SolarWindow announcers former CEO of LG Fuel Cells joins as Global Director - SolarWindow Technologies (WNDW) announced the appointment of Dr. In Jae Chung who will lead development of SolarWindow products and new technologies as Global Director, Technology & Product Innovation. Dr. Chung served as Chief Executive Officer at LG Fuel Cell Systems, and previously as Chief Technology Officer at LG Display (LPL).
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NEOG | Hot Stocks08:48 EDT Neogen, Gencove extend animal genomics partnership - Neogen announced that they have extended their strategic partnership with genomics software company Gencove to continue providing robust and innovative animal genomic testing. Neogen first entered into a partnership with Gencove in January 2020 and has since developed innovative solutions that offer the complete sequencing of entire breeding populations and provide in-depth analysis at high value to the customer.
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DDD UTHR | Hot Stocks08:47 EDT 3D Systems appoints David Leigh as CTO, Additive Manufacturing - 3D Systems (DDD) announced it is expanding its executive leadership team focused on innovation with the addition of a Chief Technology Officer for Additive Manufacturing. Effective today, industry veteran Dr. David Leigh joins the company in this capacity to expand and accelerate application development and product innovation including all hardware, software, and materials development for production-scale additive manufacturing solutions. With Dr. Leigh's arrival, 3D Systems' co-founder, Chuck Hull, will increase his emphasis on biotechnology as Chief Technology Officer for Regenerative Medicine, leading the development of solutions that are creating exciting new opportunities in regenerative medicine. Based upon the breakthroughs that Hull's team of researchers have now demonstrated through the company's partnership with United Therapeutics (UTHR), a broad range of human applications are emerging, ranging from tissue implants to human organs, in addition to laboratory applications that offer the potential to accelerate the development of new drug therapies. Mr. Hull will also continue to support Government programs with the company's next-generation large-scale metal 3D printing platform. Leigh has more than 30 years of experience in the additive manufacturing industry. Prior to joining 3D Systems, he served as the Chief Technology Officer and Chief Operations Officer for EOS, an additive manufacturing equipment vendor.
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EQOS | Hot Stocks08:46 EDT Diginex names Chris Ashe as Chief Technology Officer - Diginex has announced that Chris Ashe has joined the company as Group Chief Technology Officer. Ashe brings more than 20 years of experience in technology development and consultancy to EQONEX, having formerly held the position of CTO at Mox, the virtual bank.
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NOTV | Hot Stocks08:45 EDT Inotiv services to include medical device pathology, hires Jackson as Director - Inotiv announced the expansion of the company's pathology services to include medical device pathology. Nicolette Jackson, DVM, MS, DACVP, has joined the company as Director, Medical Device Pathology, to lead this effort. "I am pleased to announce that we are now able to provide broader and more comprehensive in-house services to our medical device clients," said Dr. Don Maul, the Company's Senior Vice President, Surgical Models. "We believe Dr. Jackson's experience and expertise will enable us to significantly reduce our dependence on outside contractors for medical device pathology."
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VERU | Hot Stocks08:44 EDT Veru announce presentation of Phase 1b/2 clinical study update for sabizabulin - Veru announced updated clinical results from the ongoing Phase 1b/2 clinical study of sabizabulin, an oral cytoskeleton disruptor being evaluated for the treatment of metastatic castration resistant prostate cancer in men who progressed on an androgen receptor targeting agent, were accepted for presentation at the European Association of Urology 36th Annual Congress. The Congress is being held virtually from July 8-12, 2021. "The data from our Phase 1b/2 trial show that oral, daily sabizabulin is well tolerated and based upon its efficacy has the potential to fill the largest and growing unmet clinical need in men who have metastatic castration resistant prostate cancer and who have developed progression of prostate cancer while being treated with an androgen receptor targeting agent, but prior to using IV chemotherapy," said Dr. Mitchell S. Steiner, Chairman, President and CEO of Veru Inc. "We are excited to be initiating the Phase 3 VERACITY trial in this patient population."
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ATRS IDRSF | Hot Stocks08:44 EDT Antares Pharma partner Idorsia initiates Phase 3 study of selatogrel - Antares Pharma (ATRS) announced that its partner Idorsia (IDRSF) initiated its Phase 3 registration study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia's P2Y12 receptor antagonist, in suspected acute myocardial infarction utilizing Antares' Quickshot auto-injector. Idorsia is initiating an international, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the clinical efficacy and safety of 16 mg selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction. The primary efficacy endpoint is the occurrence of death from any cause, or non-fatal AMI after any study treatment self-administration. The study will enroll approximately 14,000 patients who are at high risk of recurrent AMI, at approximately 250 sites in approximately 30 countries. A Special Protocol Assessment has been agreed with the U.S. Food and Drug Administration for Idorsia's selatogrel. This indicates the FDA is in agreement with the adequacy and acceptability of specific critical elements of overall protocol design for a study intended to support a future marketing application. In December 2020, the FDA designated Idorsia's investigation of selatogrel for the treatment of a suspected AMI in adult patients with a history of AMI as a "fast-track" development program. This designation is intended to promote communication and collaboration between the FDA and pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need. Idorsia selected Antares' Quickshot autoinjector for the development of selatogrel due to the robustness, reliability, ease-of-use and emergency-ready capabilities of our technology. Idorsia has confirmed the usability of the Quickshot autoinjector in the clinical development program through human factor validation studies. Antares entered into a global development agreement with Idorsia in November 2019. Under the terms of the agreement, Antares will provide clinical supply to Idorsia during clinical development in addition to fully packaged product upon FDA or foreign regulatory approval. Idorsia is responsible for the clinical development and regulatory approvals of the combination product. Idorsia will be responsible for global commercialization of the product, pending regulatory approvals, and Antares will be entitled to receive royalties on net sales of the commercial product.
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GILD | Hot Stocks08:42 EDT Gilead unit Kite study of Yescarta meets primary endpoint, event-free survival - Kite, a Gilead Company announced top-line results from the primary analysis of ZUMA-7, a randomized Phase 3 global, multicenter study showing superiority of Yescarta, axicabtagene ciloleucel, compared to standard of care SOC in second-line relapsed or refractory large B-cell lymphoma LBCL. With a median follow-up of two years, the study met the primary endpoint of event-free survival . The study also met the key secondary endpoint of objective response rate ORR. The interim analysis of overall survival OS showed a trend favoring Yescarta; however, the data are immature at this time, and further analyses are planned for the future. Kite Pharma ZUMA-7 Global Clinical Trial Sites Map - Centers Overall survival measures deaths over time from any cause. Event-free survival is defined as time from randomization to disease progression, commencement of new lymphoma therapy, or death from any cause. ZUMA-7 was conducted under a Special Protocol Agreement with the U.S. Food and Drug Administration FDA whereby the trial design, clinical endpoints and statistical analysis were agreed in advance with the Agency. "The top-line results of the randomized ZUMA-7 trial paint the picture of a potential paradigm shift in the treatment of large B-cell lymphoma," said Frederick L. Locke, MD, ZUMA-7 Lead Principal Investigator and Co-Leader of the Immuno-Oncology Program at Moffitt Cancer Center, Tampa, Florida. "The outcomes for patients relapsing after frontline chemotherapy in this study are dramatically improved with rapid referral and a single infusion of axicabtagene ciloleucel as compared to chemotherapy and consolidative autologous transplant, the longstanding second-line standard of care."
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SWAV | Hot Stocks08:42 EDT ShockWave Medical announce safety, efficacy reports on Intravascular Lithotripsy - Shockwave Medical announced that the safety, efficacy and mechanism of benefit of IVL for the treatment of coronary and peripheral artery disease has been further elucidated with the publication of three separate manuscripts in the June 28, 2021 issue of the Journal of the American College of Cardiology: Cardiovascular Interventions, comprising a pooled analysis of four studies involving coronary IVL, a randomized clinical trial involving peripheral IVL and a Mechanism of Action paper. The patient-level pooled analysis of the four prospective Disrupt CAD studies analyzed the clinical outcomes of coronary IVL in severely calcified, stenotic de novo coronary arteries prior to stenting. The analysis reports the largest cohort of patients treated with coronary IVL to date. The key findings include: Coronary IVL safely facilitated successful stent implantation and achieved high procedural success in one of the most severely calcified vessel cohorts reported for any PCI trial to date; Primary safety and effectiveness endpoints were achieved in almost all patients; Coronary IVL showed low rates of major adverse cardiovascular events and very low rates of severe angiographic complications in complex target lesions; Coronary IVL was consistently effective in achieving high acute gain and low residual stenosis. Disrupt PAD III is the largest-ever randomized controlled trial assessing the treatment of calcified lower extremity arterial lesions. Below are the key findings: Peripheral IVL was superior to PTA in the primary endpoint, procedural success, at 30-days; Vessel preparation was safely performed with IVL using a significantly lower maximum balloon inflation pressure relative to PTA and a lower rate of provisional or so-called bail-out stenting; There was no distal embolization or perforation in the IVL group; Final residual stenosis following the definitive therapy, DCB and/or stent placement, was similar between the two groups, although the PTA group required more stents. The IVL Mechanism of Action state-of-the-art review presents principles of lithotripsy therapy including the IVL system, procedure, energy distribution, and specific mechanisms for calcium modification. Key findings include: IVL fractures both superficial and deep calcium and minimizes the risk of vascular complications or thermal injury; In the treatment of severely calcified lesions, IVL offers several advantages compared to balloon-based and athero-ablative technologies; and IVL has very high levels of safety and effectiveness across multiple clinical studies involving severely calcified coronary and peripheral artery disease.
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APPH | Hot Stocks08:41 EDT AppHarvest joins Russell 2000 Index - AppHarvest announced the company is being added to the Russell 2000 index, effective Monday, June 28.
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BTN | Hot Stocks08:40 EDT Ballantyne Strong portfolio company Firefly Systems acquires Curb Taxi Media - Ballantyne Strong announced that portfolio company Firefly Systems has acquired Curb Taxi Media, a mobility media company in the U.S. Acquisition terms were not disclosed. Ballantyne Strong holds a $13M preferred investment in Firefly, which is privately held. Based on an announcement distributed by Firefly, the acquisition will provide Firefly with access to over ten thousand top-of-car screens to significantly scale Firefly's disruptive technology and network. The acquisition will establish a leadership position in the U.S. for Firefly through a presence in 11 cities, including the major media markets of New York, Chicago, Las Vegas, San Francisco, Los Angeles, and Miami. As cities reopen and out-of-home advertising returns, the Company believes that the synergy between Curb Taxi Media and Firefly will enable advertisers to capitalize on new growth opportunities through an expanded portfolio of mobility solutions available under the same umbrella and reach new markets through best-in-class taxi media solutions.
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EOSE | Hot Stocks08:39 EDT Eos Energy Enterprises appoints Berube as General Counsel, Leligdon as Senior VP - Eos Energy Enterprises announced the appointment of Melissa Berube as General Counsel and David Leligdon as Senior Vice President, or VP, of Projects, effective immediately. Berube will oversee all legal, compliance and governance functions across the organization and Leligdon will lead the design, execution, commissioning and servicing of customer projects globally. Berube most recently worked at Erickson Incorporated, a global helicopter aerial services provider and manufacturing company. Leligdon has over 25 years of industry experience with Black & Veatch, where he held a number of successive leadership roles.
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ALTO | Hot Stocks08:38 EDT Alto Ingredients joins Russell 2000, 3000 Indexes - Alto Ingredients has been added as a member of the small-cap Russell 2000 Index and broad-market Russell 3000 Index. These additions will be effective after the U.S. market opens on June 28th, as part of the 2021 Russell indexes reconstitution. The stock will be automatically added to the appropriate growth and value indexes.
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PRPH | Hot Stocks08:38 EDT ProPhase Labs added to Russell Microcap Index - ProPhase Labs announces that it has been added to the Russell Microcap Index.
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NFYEF | Hot Stocks08:37 EDT NFI Group announces first order of Enviro400EV electric double deck buses - NFI Group announced that the BYD UK and Alexander Dennis Limited electric vehicle partnership, the UK's leading electric bus producer, has supplied four zero-emission BYD ADL Enviro400EV double deck buses to Lothian Buses in Edinburgh. These buses have been funded as a flagship project of SP Energy Networks' GBP 20m Green Economy Fund.
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PFG | Hot Stocks08:37 EDT Principal Financial to exit retail fixed annuities following strategic review - Principal Financial announced changes to its portfolio and capital management strategy. These changes were approved by the Principal board of directors following a review of the company's business mix and capital management options that was undertaken as a part of a cooperation agreement with one of Principal's largest investors, Elliott Investment Management. Principal will fully exit U.S. retail fixed annuities, discontinuing new sales of its deferred annuities, payout annuities, indexed annuities and will pursue strategic alternatives, including divestiture, of the related in-force blocks, which have policy reserves of approximately $18B. Principal will continue selling its variable annuity offering, which plays a role within its complete suite of retirement solutions. In U.S. individual life insurance, Principal will fully exit the retail consumer market, discontinuing new sales of term life and universal life products to retail consumers. Building on its prior announcement to cease sales of universal life insurance with secondary guarantees, Principal will pursue strategic alternatives, including divestiture, for the in-force ULSG block as well as other related in-force blocks. The company will continue to support business owners and key executives, allowing for an even sharper focus on the business market and products with limited interest rate exposure. Principal will prioritize fee-based businesses and focus on three key areas: retirement in the U.S. and select emerging markets, global asset management, and U.S. specialty benefits and protection in the small-to-medium-sized business market. These businesses are poised for continued growth, are more capital-efficient, and leverage Principal's position and other advantages. Principal's board has approved a new authorization for the repurchase of up to $1.2B of the company's outstanding common stock. This new authorization is in addition to the approximately $675M that remains under the company's prior authorization as of March 31. Principal expects to repurchase between $1.3B-$1.7B of common shares from March 31 through the end of 2022 by utilizing capital generated from operations and reducing excess capital to target levels while retiring $300M of debt maturing in 2022. This repurchase amount does not include additional excess capital that might be generated from any transactions resulting from the strategic review.
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FGF | Hot Stocks08:36 EDT FG Financial unit FGRe announces reinsurance contract with insurtech company - FG Financial announced that the Company's reinsurance subsidiary, FG Reinsurance has entered into a reinsurance contract with a leading Insurtech company. This is FGRe's second contract since FG Global launched the reinsurance subsidiary in June 2020. The contract is with a leader in the Insurtech space that provides automotive insurance utilizing driver monitoring to predictively segment and price drivers, and is underwritten by a contracted team of reinsurance underwriters and priced by a FCAS accredited actuary, with maximum exposure being limited by a loss cap. Tom Heise, CEO of FGRe, stated, "We are pleased to execute our second contract since the launch of FGRe. Other reinsurers on this risk include some of the largest and highest rated carriers in the industry. Due to the unique structuring of this contract, our modeled returns are expected to meet or exceed internal target rates." Larry Swets, CEO of FG Financial Group, stated, "This contract reflects our strategy of patiently deploying capital in compelling, and frequently unique asymmetrical risk reward opportunities. This is a particularly attractive contract given its structure and the other established carriers involved."
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CP... | Hot Stocks08:36 EDT CP: North Dakota Congressional Delegation supports CP/KSU combination - Canadian Pacific (CP) announced that the entire North Dakota Congressional Delegation, consisting of U.S. Senators John Hoeven and Kevin Cramer and U.S. Rep. Kelly Armstrong, submitted a letter to the Surface Transportation Board expressing support for a combination of Canadian Pacific and Kansas City Southern (KSU). The text from the letter written by the Delegation reads in part: "We write to express our support for the proposed merger agreement between Kansas City Southern and Canadian Pacific Railway. We believe such an arrangement would serve the public interest by opening new markets for commodities produced in states served by CP, including North Dakota. Thank you for your attention to this important matter."
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DYAI | Hot Stocks08:36 EDT Dyadic International C1 production platform utilized in ZAPI study - Dyadic International announced findings from the Zoonotic Anticipation and Preparedness Initiative project which has been published in VACCINES, a leading peer-reviewed scientific journal. "Zoonotic diseases represent a serious global threat to human and animal health. The majority of newly evolving pathogens are zoonotic viruses. Safe and effective vaccines that can be developed rapidly following an outbreak are required to effectively combat these diseases. The efficacy, protection and safety data reported from the ZAPI study further supports the mounting library of data - demonstrating a novel approach for the C1 expression platform to be broadly applied for rapid development and manufacturing of vaccines for both human and animals". Dr. Tchelet further commented "we anticipate additional partnerships and external collaborations which will serve to further advance our commercial objectives". The successful ZAPI program focused on the following goals to enable the delivery of targeted vaccines for humans and animals, as well as therapeutic antibodies for hospital use, rapidly following a future disease outbreak by: Identifying the best protective subunit vaccines and neutralizing antibodies against potential new zoonotic diseases or strains, such as bunyaviruses or coronaviruses; Defining optimal manufacturing technologies and processes for these vaccines and antibodies to enable high-volume production capacity; Obtaining alignment with regulatory authorities and policy makers; and Securing pre-approval of new vaccine and antibody manufacturing methodologies for future emerging zoonotic viral diseases. The peer-reviewed study demonstrates the successful use of Dyadic's patented and proprietary C1-cell protein production platform to facilitate a fast, coordinated, and practical response to new infectious diseases as soon as they emerge.
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ATNF | Hot Stocks08:36 EDT 180 Life Sciences joins Russell Microcap Index - 180 Life Sciences announced that it has joined the Russell Microcap Index, effective after the U.S. market opens today, June 28.
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XSPA | Hot Stocks08:34 EDT XpresSpa announces the re-opening of XpresSpa locations by July - XpresSpa announced that it will re-open the following four top performing XpresSpa locations by July 1 with modified hours and top selling services: Hartsfield-Jackson Atlanta Int'l Airport Concourse A; Dallas/Fort Worth Int'l Airport Concourse A; Charlotte Douglas International Airport Concourse D; and Las Vegas McCarran Int'l Airport Concourse D. These re-openings are in addition to two XpresSpa locations in Dubai International Airport, UAE and one single franchised XpresSpa location in Austin-Bergstrom International Airport that are currently operating. Doug Satzman, CEO of XpresSpa Group, said, "We are encouraged by higher passenger flow at our nation's busiest airports due to the growing desire of people to return to travel in a safe manner. With our renewed optimism, we are reopening four top performing XpresSpas in time for a busy 4th of July travel holiday. However, during this pilot program, we will be limiting the operating hours of these four spas to the busiest times and will only be offering our highest performing services - massages, manicures and pedicures - to maximize profitability. We will then take our learnings from these locations and apply them to additional spas that we may selectively reopen later this summer."
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CNI KSU | Hot Stocks08:34 EDT CN announces support for combination with Kansas City Southern - CN (CNI) and Kansas City Southern (KSU) announced that their combination continues to gain support, with letters from customers, suppliers, elected officials and other stakeholders being filed with the Surface Transportation Board in favor of the companies' pro-competitive combination. Nearly 200 additional letters have been sent to CN and KCS and filed with the STB, bringing the total number of letters received to well over 1,650. Importantly, all of the letters being filed today support the companies' request that the STB approve the proposed voting trust agreement. This agreement underpins the pro-competitive CN-KCS combination, which will create a true USMCA railroad and will provide numerous new connections and service options for customers, establishing a seamless single-line service to expand North American trade and power economic prosperity. The plain vanilla voting trust, which is identical to the CP trust approved for use by the STB, is an integral component of the CN-KCS combination. It prevents premature control of KCS, allows KCS to maintain independence and protects KCS' financial health during the STB's review of the ultimate combination of CN and KCS. It also enables KCS shareholders to realize the full value of their shares without the delay related to this review. Additionally, CN has committed to divesting the sole area of overlap between the CN and KCS networks - KCS' 70-mile line between New Orleans and Baton Rouge - thereby making the combination a true end-to-end transaction, and has agreed to preserve existing route options by keeping gateways open on commercially reasonable terms. The proposed CN-KCS combination represents a pro-competitive solution that offers unparalleled opportunities for customers, employees, shareholders, the environment and the North American economy. One of the nearly 200 additional letters filed today is from Congressman Sam Graves, the Ranking Member of the House Committee on Transportation and Infrastructure. Representative Graves "urge[s] approval of the voting trust" and notes that the "CN/KCS trust should meet the unlawful control test, and also meet the public interest financial test." He also observes that "KCS is well-established and well respected within the Kansas City area and merging with CN will create new opportunities for trade and economic growth in the metro area and beyond. From a national and international perspective, the CN/KCS merger has the potential to improve commerce and access to markets by creating a single railroad that will streamline the movement of goods among Canada, the United States, and Mexico." Additional stakeholders from CN and KCS' networks, including Mayor President Sharon Weston Broome of Baton Rouge, the Board and executives of the Baton Rouge Area Foundation, Louisiana Governor John Bel Edwards, and the Port of New Orleans, continue to write letters underscoring the significant benefits available through the combination. Lastly, today's filing includes four letters of support from three local unions affiliated with Brotherhood of Locomotive Engineers and Trainmen, which collectively represent more than 1,700 engineers working on CN's United States rail operating subsidiaries and approximately 200 engineers working on KCS.
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BMRN | Hot Stocks08:33 EDT BioMarin resubmits MAA to EMA for valoctocogene roxaparvovec - BioMarin Pharmaceutical announced that the company resubmitted a Marketing Authorization Application to the European Medicines Agency for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A. In May 2021, the EMA granted the company's request for accelerated assessment. Accelerated assessment potentially reduces the time frame for the EMA Committee for Medicinal Products for Human Use and Committee for Advanced Therapies to review a MAA for an Advanced Therapy Medicinal Product. A CHMP opinion is anticipated in the first half of 2022.
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CVU | Hot Stocks08:32 EDT CPI Aerostructures receives $3.1M purchase order from U.S. Air Force - CPI Aerostructures announced that it has been awarded a $3.1M purchase order under a previously announced contract from the U. S. Air Force to provide structural modification kits, program management, logistics, and other sustainment services in support of Phase 3 of the T-38C Pacer Classic III Fuselage Structural Modification Kit Integration program and the Talon Repair Inspection and Maintenance program. In July 2019, the company announced the PCIII and TRIM contract valued at up to $65.7M. This is the third time this year the Air Force has ordered these kits and year-to-date the company has received firm orders totaling more than $16M in orders. The total funded value of the contract has now increased to $31.5M. The new order extends the currently funded period of performance into 2025. The Northrop T-38 has been the principal supersonic jet trainer used by the Air Force for more than 50 years. PCIII and TRIM are expected to increase the structural service life of the aircraft to beyond 2030.
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VINC | Hot Stocks08:32 EDT Vincerx Pharma announces inclusion in Russell 3000, Microcap Index - Vincerx Pharma announced that the Company has joined the broad-market Russell 3000 and Microcap Indexes as part of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens today, Monday, June 28, 2021.
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LKCO | Hot Stocks08:31 EDT Luokung Technology signs autonomous-driving, data services contracts - Luokung Technology announced the signing of a designated service contract for autonomous-driving data collection and data management in China with one of the world's top auto manufacturers. Luokung's wholly-owned subsidiary eMapgo Technologies Co., Ltd. has begun implementing these services and hopes to have a long-term role as this customer's autonomous-driving data service provider. EMG has also been engaged by a separate international auto parts supplier headquartered in Europe to be its designated service provider for autonomous-driving simulation testing and data management platform projects. EMG will be responsible for carrying out a portion of the autonomous-driving simulation testing, data collection and management and certain related services. In addition to the project service implementation contracts, Luokung is also working closely with this customer on future initiatives.
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QPLX | Hot Stocks08:31 EDT QOMPLX announces partnership with COMBUS - QOMPLX is proud to announce a partnership with Australian industry leader COMBUS to offer its models on the Q:HELM marketplace. The addition of COMBUS adds further geographically diverse options to improve risk management around environmental disasters, as QOMPLX continues to broadly unify data, models and services offerings for the insurance industry. These robust COMBUS models provide insight into natural and man-made disasters across Australia, ranging from bushfires to earthquakes. COMBUS built its simulation models to examine the magnitude of large events and the frequency of smaller events, providing greater understanding in estimating and predicting risk.
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EARS | Hot Stocks08:31 EDT Auris Medical to initiate market launch of Bentrio Nasal Spray in Germany - Auris Medical announced that its affiliate Altamira Medica will start the market roll-out of Bentrio, its nasal spray for protection against airborne viruses and allergens, by launching it in Germany. Bentrio will shortly become available through selected online pharmacies; over the coming months, market coverage will be expanded progressively through additional distribution channels and in further countries. "Following the intense and concerted efforts by our team and external partners, we are very excited to make Bentrio available to consumers who are looking to reduce risks from exposure to airborne viruses and allergens", commented Ueli Fankhauser, Altamira Medica's Head of Commercial. "Despite the important progress with vaccination programs, the continued emergence of SARS-CoV-2 variants and lack of full herd immunity highlight the need for additional means for self-protection such as Bentrio."
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SLGG | Hot Stocks08:30 EDT Super League Gaming, Trovo partner for Mobcrush integration - Super League Gaming announced the integration of Mobcrush's multicasting software solution with the interactive live streaming platform Trovo. This new collaboration enables streamers and content creators to expand their audience on a new and fast-growing destination for live gaming content across the globe Recently acquired by Super League, Mobcrush is a technology platform that empowers gamers and influencers to reach all of their fans simultaneously across the world's biggest digital video and social media channels. By integrating with Trovo and their 300,000 plus streamers, Mobcrush makes it easy for Trovo users to broadcast to additional destinations and grow their audiences across multiple platforms at the same time. Along with free multi-streaming distribution, this integration also includes Mobcrush's proprietary engagement solution Sponsored Live Breaks, which provides creators with a way to entertain their audience even while they are away from their camera.
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QADB | Hot Stocks08:30 EDT QAD Inc trading resumes
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QADA | Hot Stocks08:30 EDT QAD Inc. trading resumes
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HBRM | Hot Stocks08:29 EDT Herborium Group to develop proprietary protein bar - Herborium Group announced that it will be launching its new, proprietary protein derma - bar that combines the benefits of clear, healthy and youthful skin with healthy weight management, in the 4th Quarter of 2021.The target distributors such as Whole Foods, TraderJoe, Walmart and Target will be canvased to distribute this highly competitive product. There is no protein bar on the market that also targets skin health.
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PFS SZEVF | Hot Stocks08:27 EDT Provident Financial names Suez CEO Nadine Leslie to board of directors - Provident Financial Services (PFS) announced that Nadine Leslie has been named to the boards of directors of the company and its wholly owned subsidiary, Provident Bank. Leslie currently serves as Chief Executive Officer of SUEZ (SZEVF) North America, and brings more than 25 years of experience.
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KSLLF | Hot Stocks08:26 EDT Kalera appoints Curtis McWilliams to board of directors - Kalera announced the proposed appointment of Curtis McWilliams to its Board of Directors. In addition, it is expected that McWilliams will chair Kalera's Audit Committee responsible for oversight of the financial reporting and disclosure process. After an extended career in investment banking with Merrill Lynch, McWilliams transitioned to the CEO of Trustreet Properties where over the course of the following 10 years, he oversaw the growth of the company from under $100 million to over $3 billion when it was sold to GE Capital in 2007. He presently is the non-executive chair of Ardmore Shipping Corporation (ASC), an independent director for Braemar Hotels & Resorts (BHR) and lead independent director for Modiv.
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KNTE PGEN | Hot Stocks08:26 EDT Kinnate Biopharma appoint Precigen CEO Helen Sabzevari to board of directors - Kinnate Biopharma announced the appointment of Helen Sabzevari, Ph.D. to its Board of Directors. Dr. Sabzevari is currently President and CEO of Precigen (PGEN). "Her career-long efforts have helped bridge the gap between cancer cell biology and immunology, bringing these disciplines together to understand how the immune system and cancer cells interact on the broader system level and form the basis for many current efforts in immuno-oncology, particularly in the field of cancer vaccines," the company said.
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BNGO | Hot Stocks08:24 EDT Bionano Genomics added to Russell 2000 Index - Bionano Genomics announced that it was added as a member of the US small-cap Russell 2000 Index, effective after the US market opens on Monday, June 28, 2021, as part of the 2021 Russell indexes reconstitution.
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CABA ABBV | Hot Stocks08:22 EDT Cabaletta Bio appoints Scott Brun to board of directors - Cabaletta Bio (CABA) announced the appointment of veteran biopharmaceutical leader, Scott Brun, M.D., to its Board of Directors. Brun has over 20 years of wide-ranging drug development and business development experience, including his time as Vice President and Head of Pharmaceutical Development at AbbVie (ABBV). Dr. Brun will become a member of the Audit Committee and the Nominating and Corporate Governance Committee. Dr. Brun will succeed Brian Daniels, M.D., who resigned from the Board of Directors effective June 24, 2021, and subsequently joined the Scientific Advisory Board. Dr. Daniels has served on Cabaletta's Board of Directors since October 2018.
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CPRX | Hot Stocks08:20 EDT Catalyst Pharmaceuticals announces license, supply agreement with DyDo Pharma - Catalyst Pharmaceuticals announced that it has entered into an exclusive license and supply agreement with DyDo Pharma for the development and commercialization of Firdapse Tablets 10 mg in Japan for the treatment of Lambert-Eaton myasthenic syndrome. LEMS is a rare autoimmune neuromuscular disorder characterized by debilitating and progressive muscle weakness and fatigue. Under the terms of the agreement, DyDo Pharma will have joint rights to develop Firdapse, and exclusive rights to commercialize the product, in Japan. DyDo Pharma will be responsible for funding all clinical, regulatory, marketing and commercialization activities in Japan. Catalyst will be responsible for clinical and commercial supply, as well as providing support to DyDo Pharma in its efforts to obtain regulatory approval for the product from the Japanese regulatory authorities. Subject to the satisfaction of terms and conditions as set forth in the License and Supply Agreement, Catalyst will receive an upfront payment and be eligible to receive further development and sales milestones for Firdapse, as well as a transfer price on product supplied to DyDo Pharma.
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ALAC | Hot Stocks08:18 EDT Alberton Acquisition regains compliance with certain Nasdaq listing requirement - Alberton Acquisition announced that on June 23, 2021, the company received a letter from the Listing Qualifications Department of The NASDAQ Stock Market, confirming that the company had regained compliance with Nasdaq's periodic filing requirement pursuant to Nasdaq Listing Rule 5250c. As previously disclosed, the Company was notified by the Listing Qualifications Department of The NASDAQ Stock Market that it did not comply with the Periodic Filing Requirement. Based on the company's filing of its Quarterly Report on Form 10-Q for the period ended March 31, 2021 on June 22, 2021, the Listing Qualifications Department of Nasdaq has determined that the company regained compliance with the Periodic Filing Requirement.
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LUMO | Hot Stocks08:17 EDT Lumos Pharma announces OraGrowtH212 trial of LUM-201 - Lumos Pharma announced that the OraGrowtH212 Trial, a Phase 2 PK/PD study of the company's lead asset LUM-201 for the treatment of patients with pediatric growth hormone deficiency, is open for enrollment. Lumos Pharma believes an increase in the pulsatile release of endogenous growth hormone has the potential to produce a substantial improvement in height velocity in PGHD patients. The primary goal of our OraGrowtH212 Trial will be to document PK/PD data showing both a dose-related response and increased pulsatile release of GH in response to LUM-201 in a moderately growth hormone deficient subset of pediatric patients with PGHD. Similar PK/PD data showing a dose-related response and increased pulsatile release of GH was previously documented in Phase 2 studies conducted by Merck in adults and in a small subset of PGHD patients. The OraGrowtH212 Trial is being conducted at the Research Institute of Mother and Child Care, an institute of the University of Chile, at the San Borja Arriaran Clinical Hospital, a specialized pediatric center with the ability to perform the more frequent sample collection and monitoring required for this type of clinical trial. The study, A Single-Center, 6-Month, Randomized, Open-Label, Parallel Arm Study of Daily Oral LUM-201 in Naive-to-Treatment, Prepubertal Children with Pediatric Growth Hormone Deficiency, will evaluate the pharmacokinetic and pharmacodynamic effects of LUM-201 in 24 PGHD patients randomized to two separate dose cohorts. Primary outcome measures are evaluation of augmented growth hormone pulsatility and pharmacokinetics of LUM-201. Safety data and height standard deviation score will also be evaluated as secondary outcome measures.
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ENSV | Hot Stocks08:17 EDT Enservco adjourns annual meeting of stockholders to solicit proxies - Enservco Corporation announced that on June 25, 2021, it adjourned its Annual Meeting of Stockholders with respect to its proposal to reincorporate the Company in the state of Nevada. The Annual Meeting will be reconvened on July 23, 2021, at 10:00 a.m. Mountain Time at the Company's headquarters. During the period of adjournment, the Company will continue to accept stockholder votes only on its proposal to reincorporate the Company in the state of Nevada. The Company intends to engage proxy solicitation firm Advantage Proxy to contact shareholders and solicit their support for Enservco's proposal to reincorporate the Company in the state of Nevada. Such reincorporation is expected to result in significant annual cost savings for the Company. Enservco's Board of Directors strongly recommends that shareholders vote in favor the reincorporation proposal. In other business at the June 25th meeting, stockholders ratified the appointment of Plante & Moran, PLLC, as the Company's independent registered public accounting firm; reelected Richard Murphy, William Jolly and Robert Herlin as directors; and approved the adjournment of the Annual Meeting of Stockholders.
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COCP | Hot Stocks08:16 EDT Cocrystal Pharma joins Russell Microcap Index - Cocrystal Pharma announces that it will be added to the Russell Microcap Index after the U.S. market opens today, June 28, 2021.
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MDXG | Hot Stocks08:15 EDT MiMedx joins Russell 3000, 2000 Indexes - MiMedx Group confirmed that FTSE Russell will add the Company's common stock to its broad-market Russell 3000 and Russell 2000 Indexes effective after the U.S. market opens today, June 28, as part of the 2021 Russell indexes reconstitution.
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DNLI SNY | Hot Stocks08:15 EDT Denali Therapeutics announces initiation of phase 2 study by partner Sanofi - Denali Therapeutics (DNLI) announced that its partner Sanofi (SNY) has commenced dosing in a Phase 2 study of DNL758, a peripherally-restricted small molecule inhibitor of RIPK1, in patients with cutaneous lupus erythematosus. Denali and Sanofi entered into a broad collaboration in October 2018 for the global development and commercialization of RIPK1 inhibitors. This includes peripherally restricted molecules such as DNL758 and CNS-penetrant molecules such as DNL788, which is being evaluated in a Phase 1 study in healthy volunteers with potential development for neurological indications such as amyotrophic lateral sclerosis, multiple sclerosis and Alzheimer's disease. Under the agreement, Denali will receive a milestone payment of $15M related to the Phase 2 study with DNL758 from Sanofi. Sanofi is responsible for the development and commercialization of DNL758 and covers all costs related to DNL758. Denali is entitled to receive development, regulatory and sales milestone payments and royalties on product sales. RIPK1 is a critical signaling protein in the tumor necrosis factor receptor pathway and is a regulator of inflammation and cell death. CLE is a type of interface dermatitis characterized by immune cell infiltration, and inhibition of RIPK1 activity is considered a novel approach to modulate the pathophysiology of CLE.
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ATNF | Hot Stocks08:14 EDT 180 Life Sciences files plan with Nasdaq related to delayed quarterly report - 180 Life Sciences announced that as previously disclosed in the Current Report on Form 8-K, filed by 180 Life Sciences Corp. with the Securities and Exchange Commission on April 19, 2021, on April 16, 2021, the Company received a letter from the Listing Qualifications Department of the Nasdaq Stock Market stating that the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1) because it had not yet filed its Annual Report on Form 10-K for the year ended December 31, 2020 with the Commission. Nasdaq Listing Rule 5250(c)(1) requires listed companies to timely file all required periodic financial reports with the SEC. Also, as previously disclosed in the Current Report on Form 8-K, filed by the Company with the Commission on May 21, 2021, on May 19, 2021, the Company received a letter from Nasdaq stating that the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1) because it had not yet filed its Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 with the Commission. Nasdaq provided the Company 60 days, or until June 15, 2021, to submit to Nasdaq a plan detailing how the Company intended to regain compliance with Nasdaq's listing rules regarding timely filings. The Company timely submitted such plan and on June 22, 2021, the Company received notice from Nasdaq that the Company has been granted an extension until July 31, 2021, to regain compliance with Nasdaq's continued listing rule as relates to the untimely filings. In the event the Company does not regain compliance within the extension period, Nasdaq will provide the Company written notice of the delisting of the Company's securities, at which time the Company may appeal the decision to a Hearings Panel. The Company is continuing to work with its auditors to complete the 2020 Form 10-K and Q1 2021 Form 10-Q and plans to file such reports as soon as possible in order to retain compliance.
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PHUN | Hot Stocks08:13 EDT Phunware announces Ten Million PhunToken Sweepstakes - Phunware announced details of its Ten Million PhunToken Sweepstakes to coincide with the release of PhunWallet on iOS on Apple App Store, which is already available on Android on Google Play. The Ten Million PhunToken Sweepstakes will run through the end of July and will give participants an opportunity to earn daily entries to win by engaging with content inside of the PhunWallet app. Ten winners will be selected to receive one million PhunToken each. "Everyone loves to buy, but not everyone loves being sold, especially without their consent," said Alan Knitowski, President, CEO and Co-Founder of Phunware. "With PhunWallet and our dual token economy, we hope to give brands and consumers an innovative new platform to connect that gives each stakeholder more control over their data and compensates consumers fairly for their participation." PhunWallet is a cryptocurrency wallet and mobile application that supports Phunware's blockchain-enabled data exchange and mobile loyalty ecosystem powered by PhunCoin and PhunToken, respectively. While PhunCoin is a regulated store of value that seeks to compensate users for their data, PhunToken is intended to be a medium of exchange that promotes profitable behavior by unlocking key features of Phunware's Multiscreen-as-a-Service platform that reward and measure engagement.
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MDCA | Hot Stocks08:13 EDT MDC Partners issues open letter to MDC Partners regarding Stagwell - Indaba Capital Management , the largest independent shareholder of MDC Partners issued the below open letter to Chairman and Chief Executive Officer Mark Penn following several unsuccessful attempts to open up a productive, private dialogue regarding the prospective merger with Stagwell Media
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RIOCF | Hot Stocks08:13 EDT RioCan REIT announces strategic approach for mixed-use condominium projects - RioCan Real Estate Investment Trust is pleased to announce a new strategic approach for the development of its mixed-use residential condominium projects, which provides additional sources of capital and alternative income streams for the Trust. Given RioCan's long-standing track record, deep pipeline and extensive development platform, the Trust will continue to attract sophisticated investors and establish long-term relationships with capital partners for Condo development. This approach is exemplified by the Trust's recent sale of an 80% interest in its Verge Condos, a mixed-use residential Condo development along The Queensway in Toronto, to a newly formed partnership. This agreement partners RioCan with recognized institutional investors whereby the Trust retains a 20% interest and maintains project oversight as general partner and sole development manager. The partnership structure enables RioCan to monetize 80% of the land density value that it created through a successful entitlement process; earn management fees and a promote; and participate in Condo sales profits. Verge will consist of two Condo towers totalling 545 units, including 12 affordable rental units, with a retail component at grade. Recognizing development potential to intensify for the highest and best use, RioCan's development team successfully rezoned its property located along The Queensway and adjacent to its previously co-owned Queensway Cineplex site. For the development of Verge, RioCan has structured a limited partnership with four institutional investors, resulting in sales proceeds to RioCan of approximately $30.4 million, including reimbursement of its share of development costs incurred to date. Through this structure, RioCan will oversee the entire development process including site plan approval; sales and marketing; and construction of the project, creating incremental value for unitholders along the way. Condo pre-sales are anticipated to launch in August 2021 and construction is expected to start in the second half of 2022. Verge marks the first independent Condo launch under the RioCan Living banner adding to its portfolio of Condo and housing ownership developments that generate inventory profits. These inventory projects form a sustainable source of capital representing yet another lever for RioCan's growth going forward. The prominence of this utilization will be governed by market conditions at the time and composition of the Trust's balance sheet.
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ORIC | Hot Stocks08:11 EDT Oric Pharmaceuticals announces FDA clearance of IND application for ORIC-533 - ORIC Pharmaceuticals announced that the Food and Drug Administration has cleared the company's Investigational New Drug Application for ORIC-533 to proceed into a first-in-human clinical trial. ORIC-533 is a potent, orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy and immunotherapy-based treatment regimens. "The FDA clearance of our IND application for ORIC-533 is a significant milestone for ORIC as we move into the clinic with a second novel, internally discovered oncology drug candidate," said Jacob Chacko, M.D., president and CEO. "In preclinical studies, ORIC-533 has demonstrated higher potency within a high AMP environment compared to all CD73 and adenosine receptor inhibitors against which it was compared. Furthermore, in addition to the potential best-in-class properties of ORIC-533, we are excited about its differentiated clinical development plan that will explore its single agent activity in contrast to the combination studies that dominate the CD73 field today." Based on a preclinical collaboration with an academic key opinion leader that generated single agent activity in patient derived model systems in an undisclosed tumor type, the company plans to pursue a single agent clinical development plan in this indication. ORIC plans to initiate the Phase 1 clinical trial with ORIC-533 in the second half of 2021 to evaluate safety, PK and preliminary efficacy in cancer patients. This is the first of three planned IND/CTA filings for 2021, with the IND filing for ORIC-944 and CTA filing for ORIC-114 expected in the second half of the year.
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BKR | Hot Stocks08:10 EDT Baker Hughes announces investment in bio-methanation tech firm Electrochaea - Baker Hughes has announced an investment in Electrochaea, a growth stage company developing novel proprietary bio-methanation technology. Through its investment, Baker Hughes will enhance its broader carbon capture and utilization portfolio and provide an integrated solution for customers across the carbon dioxide value chain to enable the production of low carbon synthetic natural gas from captured CO2 and green hydrogen, helping meet demand for cleaner fuels to advance the energy transition and industrialization of the technology, and they will develop the commercialization of an innovative integrated carbon capture and utilization solution. Once commercialized, the solution will provide to customers a unique ability to transform CO2 emissions into clean SNG. Baker Hughes will draw from its portfolio of carbon capture technologies, including its Compact Carbon Capture design, to provide integrated solutions tailored to specific applications utilizing both CO2 sources with biogenic origin, such as biomass and waste-to-energy plants, as well as sources based on combustion of fossil fuels, such as industrial plants.
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QUISF TBBK | Hot Stocks08:10 EDT Quisitive Technology executes LOI with The Bancorp for LedgerPay - Quisitive Technology Solutions (QUISF) announced that it has successfully executed its previously announced letter of intent with The Bancorp Bank, the wholly-owned subsidiary of The Bancorp, Inc. (TBBK) to act as a sponsor for direct payment processing for Visa, Mastercard, and other major credit and debit card brands.
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HWM | Hot Stocks08:09 EDT Howmet Aerospace names Lola Lin chief legal officer - Howmet Aerospace has named Lola Lin executive VP, chief legal officer and corporate secretary. Lin will join the Howmet executive leadership team and lead the company's global legal and ethics & compliance functions as a partner to the business. Lin has a career with more than 20 years of legal expertise over multiple industries. She most recently served as senior VP and general counsel of Airgas, a U.S. supplier of industrial gases, safety products and process chemicals, where she was responsible for corporate governance, compliance matters, strategic transactions, crisis management, regulatory matters and litigation resolution.
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CBIO | Hot Stocks08:09 EDT Catalyst Biosciences receives FDA Fast Track Designation for subcutaneous MarzAA - Catalyst Biosciences announced the Food and Drug Administration has granted Fast Track Designation for Marzeptacog alfa, MarzAA, the company's subcutaneously administered next-generation engineered coagulation Factor VIIa for the treatment of episodic bleeding in subjects with Factor VII deficiency. Catalyst is currently enrolling patients with FVII deficiency in a Phase 1/2 open-label study. This trial is being conducted in parallel with the ongoing Phase 3 registration trial evaluating MarzAA for the treatment of episodic bleeds in patients with Hemophilia A or B with inhibitors. "Receiving a second Fast Track designation is another important milestone in our MarzAA development program. We look forward to our continued collaboration with the FDA to bring a safe and effective treatment to patients with Factor VII deficiency, Hemophilia A or B with inhibitors, Glanzmann Thrombasthenia and other severe bleeding disorders." said Nassim Usman, Ph.D., president and CEO of Catalyst. "MarzAA is the only subcutaneously administered bypassing agent under development for the episodic treatment of bleeding events and has the potential to significantly improve the lives of patients with several inherited or acquired bleeding disorders." FDA granted Fast Track Designation for MarzAA for the SQ treatment and control of episodic bleeding in subjects with Hemophilia A or B with inhibitors in December 2020.
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BIVI | Hot Stocks08:09 EDT BioVie added to Russell Microcap Index - BioVie announced has been added as a member of the broad-market Russell Microcap Index, effective after the US market opens on June 28, as part of the 2021 Russell indexes reconstitution.
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DARE | Hot Stocks08:08 EDT Dare Bioscience announces Phase 1 results for DARE-HRT1 - Dare Bioscience announced topline results from its Phase 1 clinical trial of DARE-HRT1. DARE-HRT1 is a novel IVR designed to deliver bio-identical 17beta-estradiol and bio-identical progesterone continuously over a 28-day period as part of a hormone therapy regimen to treat the vasomotor symptoms and genitourinary syndrome associated with menopause. The topline data from the study support DARE-HRT1's potential to be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and bio-identical progesterone hormone therapy in a convenient monthly format to treat both VMS as well as vaginal symptoms of menopause. The North American Menopause Society's guidance on hormone therapy includes that dosing estrogen and progestogen in combination may offer important benefits to women and NAMS observed that non-oral routes of administration may offer advantages over orally administered therapies. The IVR technology used in DARE-HRT1 was developed by Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School. Unlike other vaginal ring technologies, Dare's IVR drug delivery technology is designed to release more than one active ingredient via a solid ethylene vinyl acetate polymer matrix without the need for a membrane or reservoir to contain the active drug or to control the release, allowing for sustained drug delivery. The randomized, open-label, three-arm, parallel group Phase 1 study was designed to evaluate the pharmacokinetics of DARE-HRT1 in approximately 30 healthy, post-menopausal women with intact uteri. The primary objective of the study was to describe the PK parameters of two different dose combinations over 28 days. Secondary objectives of the study were to assess the safety and tolerability of DARE-HRT1 and to compare the systemic exposure of estradiol, estrone, and progesterone of DARE-HRT1 over 28 days against a daily combination of FDA-approved oral estrogen and oral progesterone products evaluated in the Phase 1 study. The study was conducted by the company's wholly owned subsidiary in Australia. Data from the study demonstrate that DARE-HRT1 successfully delivered estradiol and the progesterone over the 28-day evaluation period. The baseline-corrected steady state release of estradiol and progesterone from both the lower and higher dose versions of DARE-HRT1 evaluated in the study demonstrated steady state release levels over 28 days/ The levels of estradiol released from both the lower and higher dose formulation of DARE-HRT1 evaluated in the study achieved or exceeded the levels that were targeted for hormone therapy. Target levels of estradiol for hormone treatment for either the VMS or vaginal symptoms of menopause were established by reviewing PK levels published for FDA-approved products for both the treatment of VMS as well as the genitourinary symptoms of menopause. Based on the estradiol PK data in the DARE-HRT1 Phase 1 study, the results support the potential of DARE-HRT1 as an effective hormone therapy for both VMS and vaginal symptoms associated with menopause. The levels of progesterone released from both versions of DARE-HRT1 evaluated in the study met the objectives of releasing progesterone. Progesterone is used in hormone therapy to reduce the impact of estrogen on nontarget sites, such as the endometrium, to prevent estrogen-induced endometrial hyperplasia. In addition, the study treatment was well tolerated with the most common adverse events consistent with other vaginal products. There was only one early discontinuation due to an adverse event, which was found to be unrelated to study treatment or participation, and no serious adverse events were reported. The proportion of participants reporting adverse events was similar across all dose groups, the two DARE-HRT1 groups as well as the group receiving a daily combination of FDA-approved oral estrogen and oral progesterone products, with 89% of adverse events mild in severity and all other adverse events rated as moderate. DARE-HRT1 had a high level of acceptability in the study, with over 80% of subjects on the lower and higher dose versions of DARE-HRT1 reporting the IVR as comfortable or very comfortable. Additionally, over 80% of subjects in each IVR dose group stated they were either somewhat or very likely to use the IVR for a women's health condition or disease if needed. Dare plans to submit data from the Phase 1 clinical study of DARE-HRT1 for publication in a peer-reviewed publication. Following clinical development, Dare intends to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT1, estradiol and progesterone, to utilize the FDA's 505(b)(2) pathway to obtain marketing approval of DARE-HRT1 in the U.S.
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LSEA | Hot Stocks08:08 EDT Landsea Homes acquires 616 Homesites at Citrus Park - Landsea Homes announced that it has closed on 616 homesites at Citrus Park in Goodyear, Arizona. Construction is slated to begin in summer 2022, with sales expected to begin in fall 2022.
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PAE | Hot Stocks08:07 EDT PAE awarded position on $950M Air Force IDIQ to support foreign military sales - PAE has been selected by the U.S. Air Force as one of 22 contractors on an indefinite delivery, indefinite quantity contract vehicle to support foreign military sales transactions. The Engineering Assessment, Procurement, Integration and Contractor Logistics Support contract is valued at up to $950M over 13 years. PAE will compete for task orders to provide services that include engineering assessments, hardware procurement, integration of aircraft and intelligence, surveillance and reconnaissance sensors and contractor logistics support for foreign military fleets of fixed- and rotary-wing aircraft and intelligence, surveillance, and reconnaissance systems. The 13-year contract includes a 10-year ordering period followed by an additional three-year period of performance. Work on the contract will be performed at awardee facilities and Foreign Military Sales locations.
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EIGR | Hot Stocks08:07 EDT Eiger BioPharmaceuticals reports 'positive' Phase 2 results of Avexitide - Eiger BioPharmaceuticals announced an oral poster presentation of Phase 2 study results of Avexitide in congenital hyperinsulinism at the American Diabetes Association 81st Scientific Session. Avexitide is a targeted, first-in-class, GLP-1 antagonist in development for the treatment of HI, an ultra-rare, life-threatening, pediatric disorder of persistent hypoglycemia that results in irreversible brain damage in up to 50% of children. This Phase 2 study measured the effect of avexitide infusion on glucose requirements in 13 neonates and infants with HI. Patients were randomized to single ascending doses of avexitide or placebo by continuous IV infusion in a crossover study design. Primary endpoint was glucose infusion rate. Avexitide significantly reduced GIR when evaluated across dose levels with dose-dependent improvements observed. Avexitide 100, 200 and 1,000 pmol/kg/min ascending doses demonstrated 1.3 (15%), 2.9 (24%), and 4.3 (56%) mg/kg/min reductions in GIR relative to placebo, respectively, and entirely abolished the glucose requirement in 50% of patients at the top dose. Avexitide was well-tolerated in this study. Adverse events were typically mild in severity and transient, and there were no serious adverse events.
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TEVA | Hot Stocks08:07 EDT Teva and Bioeq in commercial pact for biosimilars - Teva Pharmaceutical and Bioeq AG announced that they have entered into a strategic partnership for the exclusive commercialization of Bioeq's FYB201, a biosimilar candidate to Lucentis, ranibizumab, in Europe, Canada, Israel and New Zealand. This strategic partnership combines Teva's long-standing commercial presence, extensive distribution network and wide-reaching sales and marketing activities across Europe and international markets with Bioeq's capabilities in the development of biosimilar drugs for highly regulated countries with stringent quality standards. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG. "Unlocking the value of biologics with biosimilars is an important new frontier in drug development that offers patients safe and effective treatment options through more affordable alternatives to branded biological products that have lost their exclusivity rights," says Sven Dethlefs, PhD, Executive Vice President, Global Marketing & Portfolio and International Markets Commercial. "This collaboration expands Teva's biosimilar portfolio and again demonstrates the company's firm commitment to creating greater access to quality medications to help improve the lives of more patients." ...According to the terms of the agreement, Bioeq will be responsible for the development, registration and supply of the biosimilar, while Teva will be responsible for commercializing the product. Teva and Bioeq will share revenue from the commercialization of the biosimilar. All other financial terms and product details remain confidential.
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HUM | Hot Stocks08:06 EDT Humana appoints Susan Diamond as permanent CFO - Humana announced that Susan Diamond, currently serving as Humana's interim CFO and segment president for the Home Business, has transitioned to the permanent role of CFO, effective immediately. Diamond joined Humana in 2006 and has served in various leadership roles across the company during her tenure. She spent eight years as part of the Medicare leadership team, with various financial, operational and line of business responsibilities. She also spent two years on the finance team, leading enterprise planning and forecasting and overseeing the company's lines of business CFOs and controllers.
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HOTH | Hot Stocks08:06 EDT Hoth Therapeutics says BioLexa 'well tolerated' in Phase 1b trial - Hoth Therapeutics announced the safety results in Cohort 1 of its first in human clinical trial of the proprietary BioLexa platform to treat atopic dermatitis, also known as eczema. BioLexa has been administered twice per day for 14 days to the first ten subjects within Cohort 1; The interim safety review indicates that BioLexa was well tolerated with no serious adverse events and no drug-related treatment-emergent adverse events observed. "Today's announcement represents a significant milestone for Hoth," stated Robb Knie, CEO of Hoth Therapeutics. "We are very pleased by the Cohort 1 results and are proceeding as planned with submission and enrollment for Cohort 2 with atopic dermatitis patients later this year."
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ONTX | Hot Stocks08:05 EDT Onconova provides update on Phase 1/2a trial of rigosertib-nivolumab combination - Onconova Therapeutics announced an update on the investigator-initiated Phase 1/2a trial of oral rigosertib plus nivolumab in advanced metastatic KRAS mutated non-small cell lung cancer. The clinical data to date provide preliminary evidence of potential anti-cancer activity of rigosertib-nivolumab combination therapy in advanced metastatic KRAS+ non-small cell lung cancer and show that the maximum tolerated dose of rigosertib in combination with nivolumab was not reached in the three cohorts of the trial's dose-escalation phase. Patients enrolled in this trial have failed multiple lines of prior therapy and all have failed immune checkpoint inhibitors in various combinations. The trial continues to recruit patients as part of the expansion phase at the highest dose of oral rigosertib defined in the current protocol. Based on the positive preliminary findings from the trial, a protocol amendment is being prepared that would allow for the evaluation of increased rigosertib doses in combination with the full dose of intravenous nivolumab, as recommended per its product label.
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QADA | Hot Stocks08:05 EDT Qad Inc. to be acquired by Thoma Bravo for $87.50 per share - Qad Inc. (QADA) announced that it has entered into a definitive agreement to be acquired by Thoma Bravo, a private equity investment firm, in an all-cash transaction with an equity value of approximately $2B. Under the terms of the agreement, QAD shareholders will receive $87.50 per share of Class A Common Stock or Class B common stock in cash. Upon completion of the transaction, Qad will become a private company. Anton Chilton will continue to lead QAD as CEO, and the company will maintain its headquarters in Santa Barbara, California. The QAD board of directors formed a special committee composed entirely of independent directors to conduct a process and negotiate the transaction with the assistance of independent financial and legal advisors. Following the special committee's unanimous recommendation, members of the QAD board other than Lopker, who recused herself, unanimously approved the merger agreement with Thoma Bravo, and recommend that Qad shareholders adopt and approve the merger agreement and the transaction. The transaction is expected to close in Q4, subject to the satisfaction of customary closing conditions, including the approval of owners of the majority of QAD shares not held by Lopker, her affiliates and other directors and officers of the company. Following closing of the transaction, Lopker intends to retain a significant ownership interest in the company and will continue to serve on the Qad board.
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KTOS | Hot Stocks08:04 EDT Kratos Defense completes engine testing under KTT's ATTAM contract - Kratos Defense & Security Solutions announced that Kratos Turbine Technologies Division has successfully completed a core engine test campaign under KTT's Advanced Turbine Technologies for Affordable Mission contract. This turbine engine development program is managed by the Turbine Engine Division of the Air Force Research Laboratory. Testing of the engine core supports the development of small, affordable, high-performance jet engines for cruise missiles and Unmanned Aerial Vehicles. During the test campaign, KTT successfully demonstrated key performance and operability targets of the core engine.
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MRNA WPP | Hot Stocks08:04 EDT Kate Cronin to join Moderna as Chief Brand Officer on July 12 - Moderna (MRNA) announced that Kate Cronin will join Moderna as Chief Brand Officer effective Monday, July 12. She will serve on Moderna's Executive Committee and report to Chief Executive Officer Stephane Bancel. "I am thrilled to welcome Kate to Moderna as our Chief Brand Officer and to the Executive Committee. Kate has an impressive track record of strategic planning and execution while using creativity and a digital-first mindset to create integrated, best-in-class campaigns for global commercial biopharmaceutical companies," said Stephane Bancel, Chief Executive Officer of Moderna. "Kate is joining the team during a time of rapid growth as we continue to scale up. I look forward to partnering with her to amplify Moderna's story and the promise of mRNA science for patients." Ms. Cronin joins Moderna from Ogilvy Health, part of WPP (WPP), where she served as Global CEO. In this role, she led the full spectrum of Ogilvy Health's core capabilities including public relations and influence, brand strategy, advertising, medical education, market access, and patient and consumer engagement. Additionally, Ms. Cronin grew Ogilvy's business in the health and wellness arena, encompassing a broad portfolio including pharmaceuticals, consumer health, insurance, hospitals, health technology and medical devices. Ms. Cronin led integrated campaigns involving social, digital, brand and public relations for Ogilvy's largest, long-term health clients including BMS, Boehringer Ingelheim, Merck and Pfizer.
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SINO | Hot Stocks08:03 EDT Sino-Global signs LOI to acquire Clamour for $3M in cash and stock - Sino-Global announced it has signed a nonbinding letter of intent to acquire Clamour, Southeast Asia's first online high-end artworks and collections trading platform. Upon entering a definitive purchase agreement, Sino-Global expects to acquire 100% of Clamour's equity interest for approximately $3M dollars in cash and stock.
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ESPR JNJ | Hot Stocks08:03 EDT Esperion appoints JoAnne Micale Foody as CMO - ESPERION (ESPR) announced the appointment of JoAnne Micale Foody, MD, FACC, FAHA as Chief Medical Officer, effective immediately. She will serve as a member of the executive team and report to Sheldon Koenig, President and CEO. Foody joins ESPERION after six years with Johnson & Johnson (JNJ), where she served in roles of increasing responsibility within the company's Janssen Pharmaceutical Company division.
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ETSY | Hot Stocks08:01 EDT Etsy to acquire Elo7 for $217M in cash - Etsy has signed a definitive agreement to acquire Elo7, a privately held marketplace for unique, handmade items, ranked as a top 10 ecommerce site in Brazil. Etsy will acquire the business for $217M in cash, subject to certain adjustments for Elo7's working capital, transaction expenses, cash and indebtedness, and reduced by the value of certain equity awards of Etsy to be granted to Elo7 employees in connection with the transaction. Following the closing of the transaction, Elo7 will continue to be headquartered in So Paulo, Brazil and operate as a standalone marketplace run by its existing leadership team. In the near term, Elo7's current run rate for GMS and revenue is expected to be neutral to Etsy's top-line results and modestly dilutive to adjusted EBITDA margin. The transaction is currently expected to close during the third quarter, subject to satisfaction of customary closing conditions.
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INOV AMZN | Hot Stocks07:59 EDT Inovalon appoints Eron Kelly as corporate president - Inovalon (INOV) announced the appointment of Eron Kelly as its Corporate President. As Inovalon's Corporate President, Mr. Kelly will be responsible for the management, operation, and results of the Company's multiple business units, their respective growth, product offerings, value achievement, and performance, as well as related support of customer and strategic relationships, total customer experience, and industry leadership. Prior to joining Inovalon, Mr. Kelly was an executive at Amazon (AMZN) where he served as the General Manager of World-Wide Product Marketing for Amazon Web Services.
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FTEK | Hot Stocks07:59 EDT Fuel Tech announces inclusion in Russell Microcap Index - Fuel Tech announced the Company's addition to the Russell Microcap Index effective at the close of trading on June 25. "We believe that inclusion in the Russell Microcap Index reflects our progress as a Company and the significance of the opportunities we are pursuing," said Vincent J. Arnone, President and CEO. "We welcome the enhanced visibility among institutional investors that addition to the Russell provides. We have a strong balance sheet with no debt, and continue to explore a range of opportunities that advance our mission of providing advanced engineering solutions that support environmental remediation, while delivering long-term value to our shareholders."
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ATCO | Hot Stocks07:59 EDT Seaspan announces newbuild order for six 15,000 TEU containerships - Seaspan, a wholly owned subsidiary of Atlas Corp., announced that it has entered into an agreement with a major shipyard for six 15,000 TEU modern newbuild containerships with anticipated deliveries beginning late in the first quarter and extending through the end of the second quarter of 2024. The six high-quality 15,000 TEU containerships will be scrubber-fitted. Upon completion, the Vessels will enter long-term charters with a leading global liner customer.
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QADB | Hot Stocks07:55 EDT QAD Inc trading halted, news pending
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QADA | Hot Stocks07:55 EDT QAD Inc. trading halted, news pending
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TPST | Hot Stocks07:52 EDT Tempest Therapeutics closes merge with Millendo, completes PIPE financing - Tempest Therapeutics announced the closing of its merger with Millendo Therapeutics. Tempest's stock will commence trading on June 28, 2021 on the Nasdaq Global Select Market under the trading symbol "TPST." In support of the merger, Tempest secured investments from a premier syndicate of healthcare investors composed of Versant Ventures, Rock Springs Capital, F-Prime Capital, Monashee Investment Management, Quan Capital, Lyfe Capital, Maven Investment Partners US, Lilly Asia Ventures and Eight Roads Ventures for a $30 million PIPE financing that closed concurrent with the completion of the merger. The net proceeds of the transaction are expected to fund the company's operations and advancement of its programs into early 2023, including: TPST-1495: completion of the ongoing monotherapy Phase 1 dose finding study, opening of a combination dose finding study of TPST-1495 with pembrolizumab, and the planned opening of both monotherapy and combination expansion studies in targeted patient populations; TPST-1120: completion of the ongoing Phase 1 study of TPST-1120 in combination with nivolumab, and the expected initiation and completion of enrollment of a global, randomized Phase 1b/2 study of TPST-1120 in combination with the standard-of-care first-line regimen of atezolizumab and bevacizumab in previously-untreated patients with advanced or metastatic HCC, pursuant to a collaboration between Tempest and F. Hoffmann-La Roche; and Research: advancement of additional novel oncology research programs, including an oral inhibitor of TREX-1 intended to selectively activate STING in tumors and stimulate anti-tumor immunity. In connection with the closing of the merger, Millendo effected a 1:15 reverse split of its common stock. Tempest has approximately 6.7 million shares of common stock outstanding after giving effect to the terms of the transaction. Tempest stockholders prior to the merger, combined with investors in the concurrent financing, collectively own approximately 81% of the outstanding shares, and prior Millendo stockholders own approximately 19% of the outstanding shares. Effective as of the closing of the merger, Geoff Nichol, chief medical officer of BioMarin, and Steve Brady, chief executive officer of Tempest, are joining Mike Raab, president and chief executive officer of Ardelyx, Tom Woiwode, managing director, Versant Ventures, Tom Dubensky, president of Tempest, and Stella Xu, managing director, Quan Capital, on the Tempest board of directors.
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LXXGF | Hot Stocks07:50 EDT Lexagene Holdings engages LaVoieHealthScience as IR, PR agency of record - LexaGene Holdings announced it has retained LaVoieHealthScience as its investor and public relations agency of record. LHS will work side-by-side with LexaGene's senior management, marketing, and financial teams to implement a comprehensive suite of IR and PR services and counsel to help the Company gain visibility among the investment community, as it charts a course toward a potential up-listing to the Nasdaq Stock Market in the United States. The Company and LHS act at arm's length and fees paid by the Company to LHS are for its services only. Neither Ms. LaVoie or LHS holds interest, directly or indirectly, in LexaGene Holdings, Inc. or its securities, or any right or intent to acquire such an interest. LexaGene will make monthly payments of $18,000 to LHS for services rendered.
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DOCRF | Hot Stocks07:43 EDT CloudMD closes Oncidium acquisition, secures credit facilities up to C$62M - CloudMD Software & Services is pleased to announce that it has closed the previously announced acquisition of Oncidium, one of Canada's leading healthcare providers to employers. Oncidium has built an ecosystem of over 500 clients servicing more than 2 million employees across Canada and more than 2,000 health care providers and medical assessors. The acquisition of Oncidium enables CloudMD to evolve its ecosystem of healthcare services through occupational health, medical management and assessment services. COVID-19 has accelerated the need for employers to have robust health and safety solutions resulting in increased demand for new approaches in the workplace. The new capabilities will be a key component of the Company's Enterprise Health Solutions Division and provide Oncidium's clients with access to our new connected healthcare platform. This transformative acquisition expands CloudMD's national footprint to include 5,500 clients and over 5 million individual lives touched. Since announcing the binding agreement, Oncidium acquired an organization specializing in independent medical evaluations and health-related services to employers and insurers. The strategic tuck-in is complementary to Oncidium and will provide immediate cost saving synergies through consolidation and integration. The business has also developed an award-winning technology platform that offers workflow management that will be used across CloudMD with our provider networks. The highly accretive business generated $17 million in revenue with positive earnings before interest, tax, depreciation and amortization for the 12-month period ending April 2021. The addition of Oncidium is immediately synergistic to CloudMD with cross-selling opportunities through a combined network of 5,500 loyal corporate clients and over 5 million covered lives. Oncidium is a rapidly growing business in the fastest growing segment of the Canadian healthcare industry, providing a significant competitive advantage compared to industry peers with a comprehensive platform, addressing whole-person healthcare through assessment, triage and support services across mental health, specialist care, healthcare navigation, short-term and long-term support, and educational resources. The acquisition of Oncidium, which has an annualized revenue run rate of $54M with an Adjusted EBITDA margin of 10%, is highly accretive to CloudMD. The acquisition also enables revenue and margin expansion for the Enterprise Health Solutions division with an annualized revenue run rate of $70M with a healthy gross margin of 38% and Adjusted EBITDA margin of 10%. On a consolidated basis, CloudMD has an annualized revenue run rate of approximately $140M with overall gross margin of 35% and positive Adjusted EBITDA. In consideration for the purchase of 100% of the outstanding securities of Oncidium, CloudMD has paid shareholders of Oncidium: $30 million in cash, subject to an estimated negative net working capital adjustment of $524,279; and $38 million in common shares of the Company, at a deemed price of $2.30 per common share. In addition to the closing considerations, the Company may pay a performance-based earnout of up to an additional $32 million in common shares of the Company or cash, at the election of the Company, and is based on Oncidium meeting certain performance milestones with respect to Oncidium's revenue and Adjusted EBITDA following closing. Specifically, the Company will pay an additional $13.5 million to the vendors if Oncidium meets or exceeds the revenue and Adjusted EBITDA targets for the year ending December 31, 2021, an additional $13.5 million if Oncidium meets or exceeds the revenue and Adjusted EBITDA targets for the year ending December 31, 2022, and an additional $5 million if Oncidium meets or exceeds the revenue and Adjusted EBITDA targets for the year ending December 31, 2023. The common shares will be subject to certain contractual restrictions on trading for a period of 30 months from the date of issuance. Concurrent with the closing of the acquisition, CloudMD is pleased to announce that it has secured credit facilities of up to $62 million with Oncidium entering into a senior credit agreement with the Bank of Montreal. The credit facilities will have a term of 3 years and are secured by a first ranking security interest in all the present and future assets and subsidiaries of Oncidium, including a guarantee from CloudMD. After closing the acquisition of Oncidium, CloudMD will have approximately $55 million in cash, that is available to fund future growth.
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OPGN | Hot Stocks07:39 EDT OpGen's Ares Genetics presents R&D pipeline updates - OpGen announced that its subsidiary Ares Genetics, which strives to become a leader in bacterial genomics and AI-powered prediction of antimicrobial resistance , presented an update on the company's R&D pipeline during two virtual seminars held on May 22 and on May 24, 2021. After having recently announced the development of a target enrichment-based, culture free genomic assay for the comprehensive surveillance of AMR pathogens, Dr. Arne Materna, CEO of Ares Genetics, now presented preliminary data of an ongoing multicenter validation of long-read nanopore sequencing of clinical isolates. With the economic burden of AMR and more importantly the associated fatalities projected to increase globally, the WHO and national public health organizations continue to emphasize the importance of improving antibiotic stewardship through use of technologies and interventions that promote the optimal use of effective antibiotics and avoid the overuse of antibiotics. Sequencing based technologies for AMR surveillance play an important role in informing the choice of appropriate first-line antibiotic treatment options. During the virtual seminars, Dr. Materna pointed out the importance of extending surveillance efforts especially into low- to mid- income countries where there is potential for becoming host to AMR outbreaks. In order to democratize genomic outbreak surveillance, new sequencing technologies are required that can meet the criteria for lower cost, lower workflow complexity and faster turnaround times to facilitate such technology adoption in these low- to mid- income countries. Ares Genetics is currently offering its expertise in isolate sequencing services and the AREScloud software for the analysis and interpretation of pathogen genome data. Ares' isolate sequencing, currently relying mostly on Illumina technology, is fully validated and highly accurate with demonstrated accuracies of 100% for pathogen identification, genotyping and multi-locus sequence typing, and 99.76% for AMR marker detection. In order to enable accurate isolate sequencing at a lower cost, faster turnaround time, and reduced complexity for laboratories, Ares Genetics is conducting a multicenter validation of the nanopore sequencing platform by Oxford Nanopore Technology in combination with AREScloud for data analysis. Preliminary results presented by Dr. Materna confirm the robust performance of pathogen genome assemblies based on ONT data, an important prerequisite for AREScloud based data interpretation and predictive AST. While error rates were consistently higher for ONT data than for the de facto standard platform Illumina, and while variability in data quality among participating laboratories could be observed, the quality of the resulting genome assemblies remained consistently high. As a consequence, the AREScloud assisted conversion of ONT data into clinically and epidemiologically relevant information proved highly accurate for participating labs, with average accuracies of consistently 100% for pathogen identification, up to 97% for AMR marker detection, and up to 100% for predictive AST. In addition to adding ONT sequencing to the Ares NGS service portfolio, Dr. Materna announced that "the company is planning to assess the performance and utility of ONT-based isolate sequencing for clinical routine use in collaboration with a major US academic hospital. In order to facilitate the workflow adoption in laboratories worldwide, results of the multicenter validation and subsequent clinical study are targeted to be published along with the validation protocols in a peer reviewed scientific journal."
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CRNX | Hot Stocks07:38 EDT Crinetics announces dosing of first patient in phase 3 PATHFNDR-1 study - Crinetics Pharmaceuticals announced the randomization of the first acromegaly patient in its Phase 3 clinical trial of paltusotine, PATHFNDR-1. This trial will be one of two planned Phase 3 studies assessing the safety and efficacy of once-daily oral paltusotine in acromegaly patients that together will evaluate paltusotine in a wide cross section of acromegaly patients. If successful, Crinetics believes its Phase 3 program could support registration of paltusotine in the United States and Europe for all acromegaly patients who require pharmacotherapy. "The dosing of the first patient in the PATHFNDR program represents a key step in paltusotine's clinical development. We believe that, if successful, these trials would support paltusotine's approval as the first nonpeptide, oral alternative to the injected standard of care for the treatment of acromegaly," said Alan Krasner, M.D., Crinetics' chief medical officer. "Our goal for paltusotine is to provide a once daily oral option for acromegaly patients that can help control excess hormone levels while at the same time relieving the burden and pain of currently available therapies."
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CVGI | Hot Stocks07:37 EDT Commercial Vehicle Group to join Russell 2000 Index - CVG announced that as part of the annual reconstitution of the Russell stock indexes, CVG has been selected to be added to the Russell 2000 index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens today, June 28, 2021.
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BLCM | Hot Stocks07:37 EDT Bellicum enters licensing agreement with UNC Lineberger, Mass General - Bellicum Pharmaceuticals announced it has entered into a license agreement with the University of North Carolina Lineberger Comprehensive Cancer Center and Massachusetts General Hospital covering certain intellectual property and technology rights regarding the company's CaspaCIDe safety switch and related technologies, and the use of rimiducid. CaspaCIDe may facilitate the use of cell therapies where cytokine release syndrome and neurotoxicities have been observed, in the pursuit of novel targets with on-target/off-tumor safety concerns, and in conjunction with next generation higher potency cell therapy constructs. This agreement with UNC Lineberger and Mass General covers four CAR-T programs incorporating Bellicum's technology currently in development, two of which are owned by UNC Lineberger and two of which are co-owned by both institutions. Under this agreement, upon out-license of each program to an industry partner, Bellicum will receive an upfront payment and be entitled to a percentage of certain consideration paid to the institutions by the industry partner and a single digit percent royalty on the global sales of the product. Additional details of the financial arrangements are not disclosed.
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PSTL | Hot Stocks07:36 EDT Postal Realty Trust announces inclusion in Russell 2000 Index - Postal Realty Trust announced it was added to the Russell 2000 Index and the broad-market Russell 3000 Index effective after the market opens on June 28,. "We are pleased to be included in the Russell 2000 Index, one of the most widely cited performance benchmarks for emerging companies," said Andrew Spodek, CEO of Postal Realty Trust. "This is another milestone for Postal Realty
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EBIX | Hot Stocks07:35 EDT EbixCash selected by Punjab National Bank to operate, manage its network - EbixCash Private, a subsidiary of Ebix, announced that India's second largest Government owned bank - Punjab National Bank, has selected EbixCash as its Network Integrator for designing, monitoring and managing its Enterprise Wide Area Network across India for a period of 3 years beginning July 1, 2021. The agreement involves the deployment of 1000+ dedicated EbixCash employees to assess, optimize and manage the EWAN, Data Center and Disaster Recovery Sites spread pan-India across the PNB headquarters, 24 zonal offices , 161 circle offices and 16,250 branches. Robin Raina, Chairman, President & CEO Ebix Inc, said, "This is a significant and highly prestigious win for EbixCash, to have been selected by one of the largest banks in the country, to service their networking needs. PNB is a technology driven bank that has always shown the way to other financial institutions in terms of its use of technology. We see this as a great step forward for our RCS IT consulting division, in terms of both top line generation and demonstrating its subject matter expertise. Also, this contract reinforces EbixCash's positioning as India's only end-to-end financial services player, with a disruptive pioneering position in back-end technology solutions as well as in the front end, distribution, exchange and consulting arenas."
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HTBX | Hot Stocks07:35 EDT Heat Biologics joins Russell Microcap Index - Heat Biologics announced that it has been added to the Russell Microcap Index, following the annual Russell indexes reconstitution, effective after the US market opens today, June 28, 2021, according to a final list of additions posted on June 25, 2021.
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WPDPF CNSP | Hot Stocks07:34 EDT WPD Pharmaceuticals plans to commence Phase 1b/II study of berubicin - WPD Pharmaceuticals provided an update on its Berubicin drug candidate clinical development program for the treatment of glioblastoma multiforme. Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin's Phase I clinical trial in adults, the first time it was tested in humans, yielded promising results with 44% of the patients with glioblastoma multiforme showing a clinical response of stable disease or better based on limited clinical data. This response rate rises to 49% in Avastin-naive patients. Importantly, Berubicin has shown evidence of improved overall survival in a patient population that currently has a dismal median survival rate of only 14.6 months from diagnosis. WPD expects final approval from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products shortly and anticipates starting a Phase II Trial in the second half of 2021. Based on the promising Phase I results, WPD plans to commence a multicenter, open-label, Phase Ib/II efficacy, and safety study of Berubicin utilizing a Simon's 2-stage design to confirm the efficacy of a single arm of Berubicin treatment, administered at the recommended Phase II dose identified in the Phase I study, on the endpoint of Overall Response Rate in up to approximately 61 patients with GBM. The trials will include an interim analysis of the first 18 patients in the first half of 2022 for efficacy and safety as well as an extensive pharmacokinetic profile for these patients. WPD is planning the Phase I clinical trial for malignant gliomas at two clinical sites in Poland. The study includes a multicenter, open-label, dose escalation Phase I study of intravenous Berubicin in pediatric patients. The purpose of this first-in-pediatrics study is to examine the safety, tolerability, and pharmacokinetics of Berubicin and to estimate its MTD and/or RP2D when administered to pediatric patients with progressive, refractory, or recurrent HGG who have completed at least 1 standard line of therapy. This study will also make a preliminary assessment of the antitumor activity of Berubicin in this patient population in up to approximately 35 patients. This Phase I trial of Berubicin represents the first ever investigation of Berubicin in pediatric brain tumors. WPD has already received Ethical Committee approval for Phase I clinical trial and has submitted its request for approval from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Information on approval and study number in European clinical trials database will be provided within 60 days. WPD expects to commence the Phase I clinical trial in Q3/Q4 2021. CNS Pharmaceuticals (CNSP), the company that sublicenses the compound Berubicin to WPD for 30 countries mainly in Europe and Asia, announced open enrollment in the United States for its clinical study evaluating the efficacy and safety of Berubicin in the treatment of recurrent GBM. CNS's potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme after failure of standard first-line therapy. The primary endpoint of the study is Overall Survival. Overall Survival is a rigorous endpoint that the U.S. Food and Drug Administration has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. Results from the trial will compare Berubicin to the current standard of care, with a 2 to 1 randomization of patients to receive either Berubicin or Lomustine.
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PTN | Hot Stocks07:34 EDT Palatin names Michael Raizman, M.D. as Chief Medical Officer - Palatin Technologies announced the strengthening of its senior leadership team with three key executive management appointments: Michael Raizman, M.D. as Chief Medical Officer; James Hattersley as Senior Vice President of Business Development; and, J. Don Wang, Ph.D. as Vice President of Product Development. In addition to joining Palatin, Dr. Raizman is a physician with Ophthalmic Consultants of Boston and a Diplomate of the American Board of Ophthalmology, with a specialized knowledge and expertise in the field of ophthalmology, including development and clinical evaluation of candidate pharmaceutical products for ocular diseases.
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BX | Hot Stocks07:33 EDT Blackstone Announces Significant Investment in advertising platform Simpli.fi - Blackstone announced that private equity funds managed by Blackstone have entered into a definitive agreement to make a significant equity investment in Simpli.fi , a leader in programmatic advertising and agency management software. Blackstone will join existing investor GTCR, a leading private equity firm, as majority shareholders in the Company. The investment, which would be made through Blackstone's flagship private equity vehicle, values the company at approximately $1.5B. Headquartered in Fort Worth, Texas, Simpli.fi is dedicated to helping media buying organizations perform more effectively and efficiently. Simpli.fi's full suite of mission critical workflow and ad buying software enables agencies and media groups to manage their core operations and execute high ROI media spend through digital ad campaigns. Each month, the Company's innovative CTV and mobile programmatic advertising platform powers over 120,000 campaigns for 30,000 active advertisers. GTCR acquired a majority interest in the Company in 2017 and, alongside co-founders Frost Prioleau and Paul Harrison, has helped build Simpli.fi into a scaled and rapidly growing platform that uniquely serves the needs of independent advertising agencies and local advertisers. Blackstone's investment will enable the Company to further accelerate innovation and organic growth initiatives as well as to continue executing on its targeted acquisition strategy. The investment from Blackstone is a continuation of its thematic focus on high quality digital advertising technology platforms and follows its recent investments in Liftoff and Vungle.
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BIMI | Hot Stocks07:32 EDT BOQI International Medical announces corporate name change - BIMI International Medical announced that on June 15 the shareholders of the company approved an amendment to the company's certificate of incorporation to change the Company's name from BOQI International Medical Inc. to BIMI International Medical Inc. The company's common stock traded under the new name and the same symbol "BIMI". Accordingly, the company filed a Certificate of Amendment to the Company's certificate of incorporation with the Secretary of State of the State of Delaware, which became effective on June 21. The bylaws of the company have also been updated with the new name.
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IAA | Hot Stocks07:32 EDT IAA enters partnership with Marhaba Cars Auction - IAA announced a strategic partnership with Marhaba Cars Auction located in the United Arab Emirates. Marhaba Cars Auction is a provider of online and in-person vehicle auctions and related shipping services. Marhaba Cars Auction will manage IAA's Auction Center in the city of Sharjah, UAE, a major hub of the country's repairable vehicle trade. As an official partner, Marhaba Cars Auction will leverage IAA's technology to operate its auctions through the U.S.-patented AuctionNow bidding platform.
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SEAS SIX | Hot Stocks07:32 EDT SeaWorld names Tom Iven as COO, effective June 28 - SeaWorld (SEAS) announced the appointment of Tom Iven to the position of COO, effective June 28. SeaWorld's Board of Directors unanimously approved the appointment. Prior to joining the company, Iven served as Senior Vice President of Park Operations for Six Flags Entertainment (SIX). Walter Bogumil's employment as COO has been terminated effective June 27.
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MGPI RCM | Hot Stocks07:31 EDT MGP appoints Erika Lapish as VP, human resources - MGP Ingredients (MGPI) has named Erika Lapish Vice President of Human Resources. .Most recently, Lapish was Vice President of Human Resources for R1 RCM (RCM) - Central Operations. files to sell common stock, no amount given
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NDAQ | Hot Stocks07:29 EDT Nasdaq welcomed 395 IPOs, 14 exchange transfers in 1H21 - Nasdaq announced that in the first half of 2021 it welcomed 395 initial public offerings, raising a total of $103 billion, extending its leadership to 30 consecutive quarters. A total of 160 operating companies listed during the first six months of 2021, representing a 78% win rate in the U.S. market. In addition to the IPOs, 14 companies transferred their corporate listing to Nasdaq, including Honeywell. Furthermore, history was made as Nasdaq welcomed Coinbase, the largest direct listing among all exchanges with $65 billion in market cap. Through the first two quarters of 2021, Nasdaq-listed companies raised 61% of all IPO proceeds, including seven of the ten largest IPOs by proceeds raised: Bumble, Applovin, Shoals Technologies, Playtika, Qualtrics, Oatly, and TuSimple.
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DLTNF | Hot Stocks07:27 EDT Delta 9 Cannabis appoints Nitin Kaushal as chair of the board - DELTA 9 CANNABIS announced the voting results on the election of directors from its 2021 general meeting of shareholders of the Company. A total of 38,056,438 common shares of the Company representing 37.30% of the 102,036,914 issued and outstanding Shares were voted in connection with the Meeting. Shareholders approved all items of business before the Meeting, including the election of directors. Shareholders also voted in favour of the reappointing of Baker Tilly HMA LLP as the auditors of the Company until the close of the next annual meeting of shareholders of the Company. Following the Meeting, effective June 25, 2021, Mr. John William Arbuthnot III resigned as President and Chair of the board of directors of the Company. Mr. Arbuthnot III will continue in his role as a director of the Company and in an advisory capacity with a focus on executive strategy, research and development, and continuous improvement initiatives. The Corporation is pleased to announce that Mr. Nitin Kaushal has been appointed the new Chair of the Board effective June 25, 2021.
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AMYT CHMA | Hot Stocks07:25 EDT Amryt Pharma announces publication of circular related to Chiasma acquisition - Amryt (AMYT) announced that: further to the Company's announcement on 5 May 2021 in relation to the proposed acquisition of Chiasma (CHMA), a circular containing notice of a general meeting to be held at the Company's headquarters at 45 Mespil Road, Dublin 4, Ireland at 2:00 p.m. on 28 July 2021, concerning the Transaction has been posted to the Company's shareholders; and the Company's annual report for the 12 months ended 31 December 2020, will be posted to shareholders in the coming days, along with a notice of general meeting. This meeting will be held at the Company's headquarters at 45 Mespil Road, Dublin 4, Ireland at 1:30 p.m. on 28 July 2021. Copies of the Circular and the Company's annual report for the 12 months ended 31 December 2020, and the notice for each of the General Meetings, when posted, will also be available on the Company's website. The Circular provides important information about Amryt, Chiasma and the Transaction. Completion of the Transaction is expected in the third quarter of 2021 and is subject to the receipt of approvals from the shareholders and stockholders of Amryt and Chiasma, respectively. The Transaction has been approved and recommended by the boards of directors of both Amryt and Chiasma and is endorsed and supported by voting agreements with lead security holders of both businesses - Athyrium Capital Management, LP, Highbridge Capital Management and MPM Capital. Under the terms of the Transaction, each share of Chiasma common stock issued and outstanding prior to the consummation of the Transaction will be exchanged for 0.396 Amryt American Depositary Shares, each representing the right to receive five Amryt ordinary shares. Based on the reference price of Amryt ADSs as of the time of final determination of the exchange ratio of $12.95 on Nasdaq on May 4, 2021, the last full trading day before the public announcement of the proposed transaction, the implied per share value of Chiasma common stock was approximately $5.13 per share or $339.2 million in total equity value, assuming the treasury stock method. The enterprise value as of May 4, 2021, the last full trading day before the public announcement of the proposed transaction, implied by the proposed transaction was approximately $268.9 million. The enterprise value implied by the Transaction is calculated incorporating Chiasma's publicly stated debt and debt like items and less Chiasma's cash, in each case as of the last publicly reported March 31, 2021 balance sheet date. Using the treasury stock method for share options, warrants and restricted stock units, Amryt holders prior to the close of the Transaction will own approximately 60% of the combined company post-closing and Chiasma holders prior to the close of the Transaction will own approximately 40% of the combined company post-closing, assuming Amryt's outstanding convertible debentures are not converted. Amryt expects the Transaction to accelerate and diversify Amryt's growing revenues and deliver estimated annual cost synergies of approximately $50 million. The Transaction will create a leading rare and orphan disease company with significant scale, an attractive mix of established cash-flow generating and long-term growth products and a diversified development pipeline.
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ZNTL | Hot Stocks07:21 EDT Zentalis expects interim results of Phase 1/2 trial of ZN-e4 in 4Q21 - The Phase 1/2 dose-escalation trial in patients with advanced non-small cell lung cancer is ongoing with 26 patients enrolled to date. ZN-e4 has been well-tolerated at all doses as of the March 25, 2021 data cut-off, and clinical activity was identified at doses greater than 80 mg QD. Interim results from the Phase 1/2 trial are expected in 4Q 2021.
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ZNTL | Hot Stocks07:21 EDT Zentalis expects interim results of Phase 1 trial of ZN-d5 in 1H22 - The Phase 1 monotherapy dose-escalation trial, initiated in 4Q 2020, has enrolled 14 patients with relapsed/refractory non-Hodgkin's lymphoma thus far in the fifth dose cohort. Additionally, no dose-limiting toxicities have been identified. Patients with acute myeloid leukemia will begin enrollment in 3Q 2021. Interim results from this Phase 1 trial are expected in 1H 2022.
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SNY | Hot Stocks07:20 EDT Sanofi says Dupixent SmPC updated with long-term data - Long-term safety data from a study of adults with moderate-to-severe atopic dermatitis treated with Dupixent will be added to the Dupixent Summary of Product Characteristics, or SmPC, following a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use, the company announced. Data from a single-arm Phase 3 open label extension trial showed the long-term safety profile in adults with moderate-to-severe atopic dermatitis treated with Dupixent and observed up to three years was generally consistent with what was observed in the controlled pivotal Phase 3 trials. The OLE trial assessed the long-term safety of Dupixent 300 mg weekly in adults who had previously participated in Dupixent trials or had been screened for a Phase 3 trial. The approved Dupixent dose in adults is 300 mg every other week.
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ZNTL | Hot Stocks07:20 EDT Zentalis reports additional data on ZN-c5 in breast cancer - The company said, "Based on the interim results from multiple ongoing trials, ZN-c5 has demonstrated the potential to support best-in-class tolerability in both monotherapy and combination settings, with strong clinical results observed. As of May 11, 2021, the following data were collected: Monotherapy Trials: In total, 56 patients with 2 median prior lines of treatment were evaluated for safety and efficacy. Across all doses from 50 mg QD to 300 mg QD, the observed CBR was 33% and the ORR was 5%. ZN-c5 generated 2 PRs at the 150 mg and 300 mg doses. Adverse events were found in less than 10% of the patients and there were no observed cases of bradycardia, visual disturbances, QTC or dizziness. Of note, treatment related diarrhea adverse event rate was 3.6%, with only grade 1 or 2 events observed. The Phase 2 monotherapy trial has been initiated and Zentalis may take multiple doses into this study. An oral dose of 50 mg QD demonstrated a CBR of 40%, with many patients in this dose cohort remaining on study drug and in the trial. Final determination of the monotherapy RP2D will occur following completion of this 50 mg QD dose cohort. Combination Dose Escalation Trials with Pfizer's CDK4/6 Palbociclib and Lilly's CDK4 and 6 Abemaciclib: Tolerability data for ZN-c5 suggests it could be best-in-class in oral SERDS, making this candidate ideal for further evaluation in combination. The two separate trials will continue to enroll patients and the Company expects to report interim results in 1H 2022 from one or more of these trials. Window of Opportunity Trial: The Window of Opportunity trial demonstrated ER degradation across all doses tested."
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NVS | Hot Stocks07:19 EDT Novartis appoints Rob Kowalski as Chief People & Organization Officer - Novartis announced the appointment of Rob Kowalski, Pharm.D., Global Head Regulatory Affairs and US Head of Drug Development as Chief People & Organization Officer. He will report to Vas Narasimhan, M.D., CEO of Novartis and become a member of the Executive Committee of Novartis, effective September 1, 2021. Steven Baert, currently Chief People & Organization Officer, will step down from the Executive Committee of Novartis, effective June 30, 2021 after 15 years with the company and almost 8 years in position. Vicki Rawlinson, US Head People & Organization will lead the function ad-interim until Dr. Kowalski takes over, the company said.
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AA | Hot Stocks07:19 EDT Alcoa sells land in Maryland for $100M - Alcoa announced that it has completed a sale of land in the state of Maryland for $100M in cash. The 2,100-acre property covers more than three square miles in Frederick County, Maryland and once served as the site of the former Eastalco smelter, which permanently closed in 2010. The sale transaction, completed on June 23, was between Eastalco Aluminum, a wholly owned subsidiary of Alcoa Corporation, and a joint venture between Quantum Loophole and TPG Real Estate Partners. Since the smelter's closure, Alcoa has worked to prepare the site for redevelopment, including removing former facilities, completing all required remediation activities, and grading the site's land for new business opportunities. In Q2, Alcoa expects to record a gain of approximately $90M from this transaction. Consistent with prior transactions, Alcoa reflects gains or losses from non-core asset sales as special items.
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ZNTL | Hot Stocks07:18 EDT Zentalis reports updates from ongoing trials of ZN-c3 - The company said, "Updates from our ongoing trials of ZN-c3 continue to support the potential for our WEE1 inhibitor, ZN-c3, to be both first-in-class and best-in-class. Since our last update at AACR in April 2021, and as of the data cut-off date of May 15, 2021: The 2 unconfirmed Partial Responses reported at AACR were confirmed, bringing the total number of confirmed PRs from our monotherapy trial from 3 to 5. Since AACR, an additional unconfirmed PR was reported in a patient with uterine serous carcinoma, resulting in 3 out of 7 USC patients enrolled having responded to treatment. Overall, the objective response rate in the USC population increased from 40% to 43% based on RECIST criteria. Additionally, within the exceptional responder population in the Phase 1 monotherapy trial, we have observed a patient with an ongoing treatment duration of more than 8 months, with a deepening response of 65% to 69% tumor size decrease based on RECIST criteria. Lower overall severe hematological adverse event rates - severe neutropenia adverse event rates decreased from 2.9% to 2.2% with an additional 11 patients enrolled since AACR 2021. Following an End-of-Phase 1 meeting, the U.S. Food and Drug Administration concurred in principle with the proposal that ZN-c3 has the potential for an accelerated approval pathway based on the proposed global study design of a Phase 2 monotherapy trial in women with recurrent or persistent USC. The trial has initiated with multiple sites open. Zentalis is planning to launch a biomarker-driven Phase 2 study pending FDA feedback. The tumor-agnostic trial will investigate ZN-c3 in patients with solid tumors that express the identified predictive biomarker, and is expected to initiate by year-end. ZN-c3 has received orphan drug designation, and rare pediatric disease designation from the FDA for pediatric osteosarcoma. The Phase 1/2 trial of ZN-c3 in combination with chemotherapy in pediatric patients with osteosarcoma is expected to initiate in 3Q 2021. If ZN-c3 were to obtain approval for the designated indication, it could be eligible for a rare pediatric disease priority voucher upon approval. Zentalis will also support two planned additional investigator-initiated trials: a trial with the Ivy Brain Center in glioblastoma multiforme and a trial with immunotherapy with Dana Farber in triple negative breast cancer. Zentalis' China JV Zentera is advancing corresponding clinical trials in China with ZN-c3."
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RNLX | Hot Stocks07:17 EDT Renalytix AI announces new data on KidneyIntelX - Renalytix announces new data demonstrating KidneyIntelX can be effective at monitoring therapeutic response and improvements in kidney health over time in adults with type 2 diabetes. The data from an international study of 1,100 individuals with diabetic kidney disease in the CANagliflozin Cardiovascular Assessment Study, was presented at the American Diabetes Association 81st Scientific Sessions Virtual Meeting. These results will be further evaluated through a growing body of real-world evidence and clinical effectiveness data driven by the KidneyIntelX multi-institutional study network in over 6,000 patients. The network is assessing the ability of KidneyIntelX to appropriately risk stratify patients in early stage kidney disease; help guide the optimal medication regimen based on individualized risk assessment; and monitor therapeutic response and kidney health using repeat testing over time. KidneyIntelX is being deployed to manage DKD populations beginning at primary care level in partnership with large health care systems including the University of Utah, the Mount Sinai Health System, and Atrium Health, Wake Forest Baptist Health. The oral presentation titled, "Longitudinal Changes in KidneyIntelX and Association with Progressive Decline in Kidney Function in the CANVAS Trial," was presented at the American Diabetes Association 81st Scientific Sessions Virtual Meeting. The new analysis based on data from the CANVAS trial demonstrated that canagliflozin reduced the KidneyIntelX risk score compared with a placebo over time, and that changes in the KidneyIntelX score from baseline to one year were strongly prognostic for future risk of DKD progression, whether the changes were treatment-induced or due to natural disease progression. These data are the second output in a series of analyses of the CANVAS cohort in conjunction with Janssen Research and Development including the role of KidneyIntelX in treatment decisions and monitoring therapeutic effect. The first set of results were presented earlier this year in April at the World Congress of Nephrology which demonstrated that KidneyIntelX is effective in identifying high risk patients with DKD who are more likely to benefit from aggressive pharmaceutical management to slow progression.
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RHHBY | Hot Stocks07:17 EDT Roche reports ENSPRYNG approved by European Commission for NMOSD - Roche announced that the European Commission has approved ENSPRYNG for the treatment of adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy. "ENSPRYNG is the first and only NMOSD treatment that is administered subcutaneously every four weeks, allowing home-dosing after appropriate training... Roche is working closely with reimbursement and health technology assessment bodies in EU member states to provide access to ENSPRYNG for people who may benefit from this treatment option as soon as possible," the company said.
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APLT | Hot Stocks07:16 EDT Applied Therapeutics added to Russell Microcap Index - Applied Therapeutics announced that the Company has joined the Russell Microcap Index. The newly reconstituted index took effect after the market close on Friday, June 25, 2021.
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AZN | Hot Stocks07:15 EDT AstraZeneca says CHMP recommends approvoal of Forxiga for CKD - AstraZeneca's Forxiga has been recommended for approval in the European Union for the treatment of chronic kidney disease, or CKD, in adults with and without type-2 diabetes, or T2D, the company announced. The Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency based its positive opinion on results from the DAPA-CKD Phase III trial that showed Forxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the risk of the composite of worsening of renal function, end-stage kidney disease and cardiovascular or renal death, compared to placebo. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "The unprecedented results of the DAPA-CKD Phase III trial show that Forxiga can significantly slow the decline of kidney function and reduce the risk of death for patients with chronic kidney disease. This positive CHMP opinion underscores Forxiga's potential to transform the future care of chronic kidney disease and brings us one step closer to providing a much-needed new treatment option to millions of patients in the EU."
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FNCH | Hot Stocks07:15 EDT Finch Therapeutics added to Russell 2000, Russell 3000 Indexes - Finch Therapeutics Group announced that it was added to the Russell 2000 and Russell 3000 Indexes as part of the 2021 Russell indexes annual reconstitution that took effect after the market close on June 25, 2021.
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RVPH | Hot Stocks07:14 EDT Reviva Pharmaceuticals added to Russell Microcap Index - Reviva Pharmaceuticals Holdings announced it has joined the broad-market Russell Microcap Index at the conclusion of the Russell U.S. Indexes annual reconstitution. The updated Index will become effective after the U.S. equity market opens today, Monday June 28, 2021.
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CMPS | Hot Stocks07:14 EDT Compass Pathways completes COMp360 psilocybin administration for 216 patients - COMPASS Pathways announced toay that it has completed psilocybin administration to the target 216 patients in its phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression. The trial is a randomized controlled, double-blinded, dose-ranging study, investigating the safety and efficacy of psilocybin therapy and comparing a 25mg and 10mg dose of COMP360 psilocybin with a 1mg dose, administered in conjunction with psychological support from specially trained therapists. The 216th patient in the trial had their psilocybin session late last week. The number of patients included in the final analysis will be approximately 230, with all psilocybin sessions expected to be completed by 8 July. Patients are followed-up for 12 weeks after their psilocybin session. COMPASS remains on track to report data in late 2021.
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ANDA SNAX | Hot Stocks07:13 EDT Andina announces effectiveness of registration statement for Stryve combination - Andina Acquisition Corp. III (ANDA) announced that on June 25, 2021, the U.S. Securities and Exchange Commission declared effective its Registration Statement on Form S-4, which includes a definitive proxy statement/prospectus in connection with Andina's special meeting of shareholders. At the Special Meeting, shareholders of Andina will consider the previously announced proposed business combination with Stryve Foods, an emerging healthy snack platform disrupting traditional snacking categories. The declaration of effectiveness by the SEC and the filing of the definitive proxy statement is an important step in Stryve becoming a publicly traded company, with the goal of being listed on the NASDAQ under the symbol "SNAX" at the close of the Transaction. Andina will hold the Special Meeting at 10:00 AM Eastern Time on July 19, 2021, to approve, among other things, the proposed Transaction. Shareholders of record at the close of business on June 7, 2021 will be entitled to receive notice of and to vote at the Special Meeting. Registration for the Special Meeting will begin on July 12, 2021 at 9:00 AM Eastern Time. Andina shareholders will need a control number assigned by Continental Stock Transfer & Trust Company to enter the Special Meeting.
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DTIL SWTX | Hot Stocks07:12 EDT Precision BioSciences, SpringsWorks dose 1st patient in PBCAR269A trial - Precision BioSciences (DTIL) and SpringWorks Therapeutics, Inc. (SWTX) announced that the first patient has been dosed in the combination arm of Precision's Phase 1/2a trial evaluating PBCAR269A. In the study, Precision's investigational allogeneic BCMA-targeted CAR T cell therapy will be combined with nirogacestat, SpringWorks' investigational gamma secretase inhibitor (GSI), in patients with relapsed/refractory multiple myeloma. "We are pleased to begin dosing patients in the combination arm of our ongoing Phase 1/2a study evaluating PBCAR269A, our first-generation allogeneic CAR T candidate targeting BCMA in patients with R/R multiple myeloma. BCMA is a well-established therapeutic target for multiple myeloma and this arm of the study pairs PBCAR269A with SpringWorks' nirogacestat, a gamma secretase inhibitor, a combination intended to offer strong mechanistic rationale for clinical benefit," said Alan List, M.D., Chief Medical Officer at Precision BioSciences. "As we look forward to sharing interim monotherapy data for PBCAR269A later this year, we are also conducting IND enabling studies to advance PBCAR269B, an immune-evading, stealth cell formulation into the clinic in 2022. We have high conviction in both our technology and BCMA as a target and we are pursuing a broad, data-driven strategy to inform our future development plans for this indication." "We are pleased to advance this combination into the clinic so we can evaluate if nirogacestat paired with PBCAR269A offers a safe and efficacious treatment option for patients with multiple myeloma," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "We have made significant progress in developing nirogacestat as a cornerstone of BCMA combination therapy across modalities and look forward to generating clinical data with all of our partners."
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GILT | Hot Stocks07:12 EDT Gilat Satellite $9M in orders for support of low earth orbit constellation - Gilat Satellite Networks announced that it received orders of $9M for support of gateways of Low Earth Orbit constellations. Gilat's subsidiary, Wavestream, was chosen as the vendor of choice to supply Gateway Solid State Power Amplifiers to a leading satellite operator to support the LEO constellation gateways. The orders were received as part of the previously announced contract. Wavestream is proceeding according to plan with orders now exceeding 800 Gateway-Class SSPAs. Wavestream's PowerStream 160Ka is designed specifically for networks using wide bandwidth uplinks and high order modulation schemes, thus best addressing the stringent requirements of Non-Geostationary Satellite Orbit constellations installed in remote locations.
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GRTX | Hot Stocks07:11 EDT Galera Therapeutics completes enrollment of phase 3 trial of avasopasem - Galera Therapeutics announced completion of enrollment in its pivotal Phase 3 ROMAN trial of avasopasem manganese for the treatment of severe oral mucositis in patients with locally advanced head and neck cancer undergoing standard-of-care radiotherapy. This achievement has triggered a $37.5M milestone payment from funds managed by Blackstone Life Sciences to Galera under the amended royalty agreement. The ROMAN trial is a randomized, double-blind, placebo-controlled trial in 455 patients designed to evaluate the ability of avasopasem to reduce radiation-induced SOM in patients with locally advanced HNC, receiving seven weeks of standard-of-care radiotherapy plus cisplatin. Patients were randomized to one of the two treatment groups to receive 90 mg of avasopasem or placebo by infusion on the days they receive their radiation treatment. The primary endpoint of the trial is the reduction in the incidence of SOM through the radiotherapy period. Secondary endpoints include the reduction in the severity of SOM and the number of days patients experience SOM. The FDA has granted Fast Track and Breakthrough Therapy Designation to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy.
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DPZ DKNG | Hot Stocks07:11 EDT Domino's Pizza launches carside delivery 2-minute guarantee - Domino's Pizza (DPZ) believes in offering customers the best and most convenient carryout experience possible, so much so that it is launching a new guarantee. Domino's Carside Delivery 2-Minute Guarantee is simple: order Domino's Carside Delivery online, check in when you arrive, and as soon as your order is ready, a Domino's team member will head to your car in less than two minutes or your next pizza is free. But that's not all. Domino's and DraftKings (DKNG) have launched Domino's Carside Delivery 2-Minute Guarantee Over/Under Challenge as well, giving customers the chance to predict if Domino's Carside Delivery nationwide will be quicker than two minutes, more or less than 80% of the time, for the chance to win a share of $200,000. Domino's Carside Delivery 2-Minute Guarantee Over/Under Challenge is free to play and is taking place now through July 12, 2021, at draftkings.com/dominos and on DraftKings' Daily Fantasy app. Those who correctly predict Domino's performance will split the cash prize of $200,000 at the end of the challenge.
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CLNN | Hot Stocks07:10 EDT Clene added to Russell 2000 Index - Clene announced that it has been added as a member of the U.S. small-cap Russell 2000 Index and the all-cap Russell 3000 Index, effective after the U.S. market opens today, June 28, 2021, as part of the 2021 Russell indexes reconstitution.
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ACET | Hot Stocks07:10 EDT Adicet Bio added to Russell 2000 Index - Adicet Bio announced that the Company has been added to the Russell 2000 Index, effective June 28, 2021, as part of the 2021 Russell indexes annual reconstitution.
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TNXP | Hot Stocks07:09 EDT Tonix Pharmaceuticals added to Russell 2000, Russell 3000 Indexes - Tonix Pharmaceuticals announced that Tonix was added to the broad-market Russell 3000 index and the small-cap Russell 2000 Index, effective after the U.S. market opens today, June 28, 2021, as part of the annual reconstitution of the Russell stock indexes.
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AGIO | Hot Stocks07:08 EDT Agios Pharmaceuticals submits MAA to EMA for mitapivat - Agios Pharmaceuticals announced that it has submitted a Marketing Authorisation Application, or MAA, for mitapivat to the European Medicines Agency, or EMA, for the treatment of adults with pyruvate kinase deficiency in the European Union. This submission follows the company's recent New Drug Application submission of mitapivat to the U.S. Food and Drug Administration for treatment of adults with PK deficiency in the U.S. "With both our NDA and MAA filings, we are poised to deliver the first potentially disease-modifying therapy for people with PK deficiency, a chronic, lifelong hemolytic anemia characterized by serious complications affecting multiple organs," said Chris Bowden, M.D., chief medical officer at Agios. "There are no approved therapies for PK deficiency, and the current management strategies of blood transfusions and splenectomy are associated with both short- and long-term risks, including iron overload, blood clots and increased risk for infections... We are looking forward to working with both the FDA and EMA to provide a potential new treatment option for this community that may help address the significant unmet needs of PK deficiency patients." Like the NDA, the MAA submission is based on results from two pivotal studies, ACTIVATE and ACTIVATE-T. A full analysis of these data - including patient-reported outcomes - was recently presented at the European Hematology Association Virtual Congress.
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RMTI | Hot Stocks07:07 EDT Rockwell Medical files pre-IND meeting request with FDA for FPC trial - Rockwell Medical announced that it has submitted a pre-IND meeting request with the U.S. Food and Drug Administration in support of its proposed Phase 2 clinical trial of Ferric Pyrophosphate Citrate, designed for the treatment of iron deficiency anemia and maintenance of hemoglobin in patients receiving infusion therapy in the home setting.
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SNY AZN | Hot Stocks07:07 EDT Sanofi reports 'positive' results in RSV Phase 2/3 MEDLEY trial of nirsevimab - In "positive" topline results from the Phase 2/3 MEDLEY trial, nirsevimab showed a similar safety and tolerability profile compared to palivizumab when administered to preterm infants or those with chronic lung disease or congenital heart disease entering their first respiratory syncytial virus season, Sanofi (SNY) announced. Safety and tolerability were assessed by the occurrence of all treatment emergent adverse events and treatment emergent serious adverse events. Nirsevimab, being developed in partnership with AstraZeneca (AZN), is the first investigational extended half-life monoclonal antibody aiming to protect all infants entering their first RSV season, when they are at highest risk for severe RSV disease. MEDLEY is the third pivotal trial to report positive data for nirsevimab. In April, Sanofi reported that nirsevimab met its primary endpoint of achieving a statistically significant reduction of LRTI caused by RSV in healthy preterm and term infants in the Phase 3 MELODY trial. Coupled with recently published Phase 2b trial results, MELODY and MEDLEY results are part of a robust body of evidence demonstrating the potential of nirsevimab to provide RSV protection to all infants. Results from the MELODY and MEDLEY trials will be presented at forthcoming scientific congresses and, along with the Phase 2b results, will form the basis of global regulatory submissions planned for 2022.
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ADMP | Hot Stocks07:07 EDT Adamis Pharmaceuticals issues letter to stockholders regarding Tempol treatment - Adamis Pharmaceuticals issued the below letter to stockholders. The letter said, "The Board of Directors (the "Board") appreciates your continued investment in Adamis Pharmaceuticals Corporation ("Adamis" or the "Company"). Ahead of our Annual Meeting of Stockholders on July 16th (the "Annual Meeting"), we want to once again urge you to vote to re-elect all five members of the Board. We believe maintaining continuity in the boardroom is critical as Adamis focuses on driving pipeline progress and initiating its phase 2/3 trial for examining the effectiveness of Tempol in the treatment of COVID-19. We recognize that the road to value creation in the biotechnology industry often includes detours and hurdles. Like many other companies pursuing new drugs and treatments for complex diseases and conditions, Adamis has certainly encountered its own disappointments and setbacks in the course of working to develop, secure approvals for and commercialize our products. The Board is grateful to you for sticking with us - and we want you to know we are listening to you and learning from your feedback... Notably, we believe our role in trying to fight the pandemic is becoming even more vital now that the Delta variant is rapidly spreading across the globe. We believe our efforts related to Tempol are providing us with a unique opportunity to pursue value for society and our stockholders. The Board is focused on this opportunity. Regrettably, Jerald A. Hammann - an opportunistic holder of 1,000 shares with no biopharmaceutical expertise, no public company experience and no articulated strategy - is continuing to wage costly litigation and is attempting to run a slate of directors to take control of the Board at this year's Annual Meeting. Mr. Hammann is doing this despite the fact that the Delaware Court of Chancery ruled against his effort to enjoin the Company from sending you our proxy materials, soliciting your votes and holding our Annual Meeting as currently scheduled. We contend that Mr. Hammann's seemingly unlawful, disingenuous and disruptive efforts are a threat to Adamis and its stockholders. The Board urges stockholders to reject Mr. Hammann's campaign of attacks, distortions and mischaracterizations. Mr. Hammann has no plan or relevant operating background in the biotechnology industry. It is not the time to veer off the Company's path and risk undermining initiatives pertaining to Tempol and our other product initiatives. Once again, we thank you for your investment in Adamis. We encourage you to vote on the WHITE proxy card to elect our full five-member slate and help us sustain the Company's momentum."
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TRVN | Hot Stocks07:06 EDT Trevena added to Russell 2000, Russell 3000, Russell Microcap Indexes - Trevena announced it has been added to the small-cap Russell 2000 Index, the broad-market Russell 3000 Index, and the Russell Microcap Index, effective after the U.S. equity markets open today, Monday, June 28th, 2021.
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AVXL | Hot Stocks07:06 EDT Anavex announces results of ANAVEX 2-73 in phase 2 clinical trial - Anavex Life Sciences reported that the predictive biomarker of response established with SIGMAR1 mRNA expression correlates significantly with responses in primary and secondary clinical efficacy endpoints from the proof-of-concept randomized, double-blind, placebo-controlled Phase 2 trial that randomized 132 patients with Parkinson's disease dementia. Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity. ANAVEX 2-73 treatment resulted in significant mRNA expression increase of SIGMAR1, the gene encoding for the receptor targeted by ANAVEX 2-73, which correlated with clinical efficacy as measured by primary cognitive efficacy endpoints, CDR system Continuity of Attention and CDR system Power of Attention, and secondary Parkinson's efficacy endpoints Movement Disorder Society-Unified Parkinson's Disease Rating Scale 4, MDS-UPDRS Part III and MDS-UPDRS Total. ANAVEX 2-73 high dose demonstrated statistically significant improvements compared to placebo for MDS-UPDRS Total score. From baseline to end of trial at 14 weeks, MDS-UPDRS Total score improved by -10.98 points in the ANAVEX 2-73 high dose group and worsened by 3.53 points in the placebo group, an adjusted mean difference of -14.51 points. This corresponds to a relative improvement of 18.9% over 14 weeks. This exceeds an empirically established cutoff score of -7.1 for detecting meaningful clinical change. Treatment with ANAVEX 2-73 not only slows the progression of motor and non-motor symptoms in moderately advanced patients with Parkinson's. ANAVEX 2-73 also resulted in clinically meaningful improvements as measured by the global composite score of Parkinson's disease symptom severity, MDS-UPDRS Total score on top of standard of care including dopaminergic therapy, levodopa and other anti-PD medications after 14 weeks of treatment, suggesting ANAVEX 2-73's global capability of slowing and reversing symptoms that progress in Parkinson's disease, an urgent unmet medical need. Sleep was a tracked variable both subjectively and objectively including sleep continuity or incidence of sleep disorders symptoms. ANAVE 2-73 does not impair sleep and has a positive effect on REM sleep behavior disorder. Previously reported cognitive outcome measures from this study relevant to Alzheimer's disease presented at CTAD 2020 observed statistically significant improvement of CDR system Episodic Memory of +42.22 between ANAVEX 2-73 high dose and placebo, which was dose-dependent. ANAVEX 2-73 is currently being tested in late-stage placebo-controlled ANAVEX 2-73 Phase 2b/3 clinical Alzheimer's disease study, which recently completed enrollment, and is utilizing the same dosing regimen as in the above-described completed Parkinson's disease dementia study with differentiated patient selection criteria. With this biomarker-correlating efficacy data of this proof-of-concept Phase 2 13 study in patients with Parkinson's disease dementia, data will be submitted to the U.S. Food and Drug Administration to seek regulatory guidance. Data from this study will be submitted later this year for presentation at a scientific medical meeting.
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BBQ | Hot Stocks07:06 EDT KWM proposes financing terms for BBQ's Village Inn/Bakers Square deal - The company said, "Congratulations on the exceptional purchase of Village Inn & Bakers Square, we look forward to the sizeable free cash flow and growth this new asset will provide - along with BBQ Holdings existing businesses. We are troubled by the dilution given the $21M in cash on the balance sheet combined with a robust free cash flow outlook and stark undervaluation of the shares. We are offering the company a $5M convertible preferred financing at 5% and convertible into common stock at $20/share, with few restrictive covenants. We urge the board to act in the best interest of shareholders by accepting our "balance sheet strengthening" preferred financing that will significantly minimize previously planned dilution of common stock. A $5M preferred at 5% with few covenants and convertible at $20/share is clearly significantly more beneficial to shareholders than selling common stock at a net price in the low teens, and especially given the company will have net cash post raise!"
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TECH | Hot Stocks07:04 EDT Bio-Techne announces opening of new Ireland facility - Bio-Techne announced the opening of its new Ireland facility located in Dublin. This new facility reflects Bio-Techne's commitment to supporting the broader life sciences industry in Europe as well as expectations for continued growth and staffing needs in this geography. The Dublin facility is responsible for servicing Bio-Techne's growing number of European-based academic and biopharma customers with the company's full portfolio of life science tools and diagnostic reagents, with the new site serving as the region's primary distribution hub. The 25,000 square foot facility strengthens Bio-Techne's supply chain, positioning the company to address the growing demand for its portfolio of life science reagents and proteomic analytical tools.
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IR | Hot Stocks07:04 EDT Ingersoll-Rand to acquire Maximus for CAD$135.4M - Ingersoll Rand has entered into an agreement to acquire Maximus, a provider of digital controls and Industrial Internet of Things IIoT production management systems for the agritech market. The all-cash transaction, valued at CAD$135.4m is expected to close in Q3 upon obtaining required regulatory approvals. Upon transaction close, Maximus will join the PST segment. "Smart, connected products, digital capabilities and technology are core to our growth and today's announcement delivers on our commitment to deploy capital in pursuit of this strategy," said Vicente Reynal, chief executive officer of Ingersoll Rand. "Maximus has built significant expertise in controls and IIoT technology that aligns well with Ingersoll Rand and our current brands. Leveraging Ingersoll Rand Execution Excellence will help drive additional innovation and significant synergies with Dosatron and other PST brands. This acquisition is expected to generate significant value for our stockholders." The Maximus System is a centralized controller and IIoT platform which connects to farm devices and simplifies facility management. The System tracks the state of farm infrastructure and automates tasks based on artificial intelligence (AI) logic. Based in Montreal, Canada, Maximus has approximately 100 employees and annual revenue of approximately CAD$40M The company has experienced greater than 30% revenue CAGR over the past five years, and is expecting strong double digit growth over the next five years. In 2021 Maximus is expected to achieve Adjusted EBITDA margins in line with current PST segment levels, and Ingersoll Rand expects to achieve meaningful margin improvement and a high single digit post-synergy EBITDA multiple by the end of year three of ownership.
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GSS | Hot Stocks07:03 EDT Golden Star Resources revises 2021 production guidance - The company stated, "As previously highlighted in the Q1 2021 financial and operating results press release, the commissioning process for the new paste fill plant returned lower than expected strength test results in the first test stope. This outcome has resulted in a delay to the commissioning process. Further test work and analysis is being carried out to ensure that the paste plant produces material at the required strength to enable safe mining operations and successful pillar extraction. This test work is ongoing and positive progress has been made, with the most recent strength results more aligned with the design parameters. These need to be confirmed, and given the long testing cycles, we now estimate that the commissioning process will be completed in Q4 2021. As a result, the secondary stopes planned for mining in 2021 have been deferred to 2022, when we expect to extract the secondary stope material as intended. The delay to the commissioning of the paste plant impacts 21% of our planned ore tonnes for 2021. This impact has been exacerbated by the lower than planned development metres, as reported in the Q1 update, primarily due to operator availability caused by COVID-19 related issues. The resolution of both issues is on track for completion in 2021. However, resequencing the mine plan for this year means that the volume of ore available will be lower than initially planned at a slightly lower grade due to the loss of the higher-grade secondary stopes. Production guidance is now reduced to 145-155 thousand ounces, and the all-in sustaining cost is now increased to $1,150-1,250 per ounce. The capital expenditure guidance range is unchanged at $45-50m. The $14M exploration budget for the year is in line with the previous guidance, albeit with an increase in the allocation of spend to the up-dip and down-dip, in-mine, drilling targets that have delivered positive results so far this year."
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CANF | Hot Stocks07:03 EDT Can-Fite BioPharma signs Piclidenoson development agreement with Vetbiolix - Can-Fite BioPharma announced it has signed a development and commercialization agreement with Vetbiolix, a France-based veterinary biotech company, for the development of Piclidenoson for the treatment of osteoarthritis in companion animals including dogs and cats. Vetbiolix will have the exclusive right to Piclidenoson in the veterinary osteoarthritis market for two years, during which time Vetbiolix will conduct proof-of-concept studies and cover all associated costs. If the studies yield positive data and Vetbiolix exercises its option to obtain the license from Can-Fite, then Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval for veterinary use.
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RZLT | Hot Stocks07:03 EDT Rezolute added to Russell Microcap Index - Rezolute has been added to the Russell Microcap Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the US market opens on June 28.
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JOAN | Hot Stocks07:02 EDT Joann set to join Russell 2000 Index - JOANN announced that it has formally joined the Russell 2000 Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the US market opens on June 28.
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SIX | Hot Stocks07:02 EDT Six Flags offers $500-$1,000 bonuses to seasonal employees - Six Flags announced it is rewarding its team members with extra cash this summer. Seasonal team members employed as of July 1, and who work through September 6, can earn up to an additional $500-$1,000 or more.
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EYPT | Hot Stocks07:01 EDT EyePoint joins Russell 2000 Index, Russell 3000 Index - EyePoint Pharmaceuticals announced that the Company will be added to the small-cap Russell 2000 Index and the broad-market Russell 3000 Index effective after the US market opens on June 28, 2021 as a result of the annual Russell index reconstitution.
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SNDX | Hot Stocks07:01 EDT Syndax: FDA grants Fast Track Designation to SNDX-5613 - Syndax announced that the U.S. FDA has granted Fast Track Designation to SNDX-5613 for the treatment of adult and pediatric patients with relapsed or refractory acute leukemias harboring a mixed lineage leukemia rearranged or nucleophosmin mutation. SNDX-5613 is the company's highly selective, oral menin inhibitor.
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AZN | Hot Stocks07:00 EDT AstraZeneca says first participants vaccinated in COVID-19 variant vaccine trial - The first participants in a Phase II/III trial for the new COVID-19 variant vaccine AZD2816 were vaccinated to assess its safety and immunogenicity in both previously vaccinated and unvaccinated adults, AstraZeneca announced on June 27. The trial will recruit approximately 2,250 participants across UK, South Africa, Brazil and Poland. AZD2816 will be administered to individuals who have previously been fully vaccinated with two doses of Vaxzevria or an mRNA vaccine, at least three months after their last injection. In non-vaccinated individuals, AZD2816 will be given as two doses, four or twelve weeks apart, or given as a second dose following a first dose of Vaxzevria four weeks apart. AZD2816 has been designed using the same adenoviral vector platform as Vaxzevria, with minor genetic alterations to the spike protein based on the Beta B.1.351, or South African, variant. Sir Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "It is important we continue to stay ahead of genetically distinct variants of the coronavirus. AZD2816 should help broaden individuals immune response against emerging variants of concern. Initiating the Phase II/III trial for AZD2816 means we can be prepared should a variant vaccine be required in the future."
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OCN | Hot Stocks06:46 EDT Ocwen set to join Russell 2000, Russell 3000 Indexes - Ocwen Financial announced that it is set to join the Russell 2000 and Russell 3000 Indexes at the conclusion of the 2021 Russell indexes annual reconstitution, effective at the opening of the U.S. equity markets on Monday, June 28.
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JBT | Hot Stocks06:35 EDT John Bean Technologies to acquire Prevenio for $170M, sees accretion - JBT Corporation announced it signed a definitive agreement to acquire Prevenio, a provider of food safety solutions primarily for the poultry industry. Prevenio, formerly known as CMS Technology, provides pathogen protection through its anti-microbial delivery solution that enhances food safety and integrity. The acquisition of Prevenio will enhance JBT's recurring revenue portfolio and furthers its investment in solutions that support its customers' daily operations. The company is headquartered in Bridgewater, New Jersey, with a full-service lab in Bogart, Georgia specializing in microbiology focused on both field and R&D testing. The agreed purchase price is $170M, before customary post-closing adjustments, and the transaction is expected to close early in the third quarter. Prevenio expects run rate annual revenue at the end of 2021 of approximately $50M with EBITDA margins accretive to JBT FoodTech's Adjusted EBITDA margins. Including transaction-related costs and after purchase price accounting associated with the acquisition, the transaction is expected to have a minimal impact to GAAP earnings per share, and be accretive to adjusted EPS by approximately 3c in 2021. In 2022, Prevenio is expected to be accretive to GAAP and adjusted EPS by approximately 10c.
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MNOV | Hot Stocks06:35 EDT MediciNova to conduct mouse study to develop MN-166 - MediciNova announced it will conduct a mouse study to investigate the efficacy of MN-166 in a murine model of chlorine-induced lung injury and lethality. After mice are exposed to chlorine gas and treated with MN-166 or control, the study will evaluate survival, clinical outcomes, body weights, lung weights, and upper respiratory tract histopathology. This mouse study and the sheep study announced recently are the result of a partnership between MediciNova and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to repurpose MN-166 as a potential medical countermeasure against chlorine gas-induced lung damage such as acute respiratory distress syndrome and acute lung injury.
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SY | Hot Stocks06:33 EDT So-Young to acquire controlling interest in Wuhan Miracle Laser Systems - So-Young announced that it has entered into definitive agreements with Wuhan Miracle Laser Systems and shareholders of Wuhan Zeqi Technology Co., Ltd., a shareholder of Wuhan Miracle, to acquire controlling interest in Wuhan Miracle for a total consideration of RMB 791M. The closing of the transaction is subject to customary closing conditions and is currently expected to occur in the third quarter.
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DPW | Hot Stocks06:31 EDT Ault Global Holdings to acquire up to 40% of Adtech Pharma for $3M - Ault Global Holdings announced it has entered into a securities purchase agreement to acquire up to 40% of the current equity in Adtech Pharma for $3M. Adtech is a biotech firm that has developed a novel formulation of a sole-sourced synthetic cannabinoid therapeutic targeting glaucoma. Adtech believes that there is a worldwide marketplace of over $4B in annual sales for glaucoma eye drop therapeutics.
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MNKD | Hot Stocks06:25 EDT MannKind announces CMS policy change to LCD allowing both Afrezza, CGMs - MannKind said it appreciates the recent efforts of the Centers for Medicare and Medicaid Service, or CMS, in conjunction with the Medicare Administration Contractors, or MACs, to implement a policy change to the Local Coverage Determination, or LCD, allowing the approval to Medicare patients living with diabetes to select both Afrezza and continuous glucose monitors, or CGMs. Effective July 18, the criteria change lifts the restriction on patients of having to choose between the two diabetes tools.
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VGZ | Hot Stocks06:16 EDT Vista Gold receives final $1M Guadalupe de los Reyes payment - Vista Gold announced receipt of the final $1M payment from Prime Mining Corp. As announced on June 15, 2020, Prime Mining was required to pay Vista $2.1M in lieu of Vista being granted certain royalties and back-in rights relating to the Guadalupe de los Reyes gold / silver project in Mexico. The first payment of $1.1M was paid in January 2021. With this $1M payment, Vista has no remaining right to be granted the royalties and back-in rights. Frederick Earnest, President and CEO of Vista, commented, "We are pleased to receive this final payment and successfully complete this agreement with Prime Mining."
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UCL | Hot Stocks06:09 EDT uCloudlink announces distribution agreement with London-based business partner - uCloudlink announced a new distribution agreement with a London-based business partner. Under the non-exclusive agreement, the new partner will market, distribute and sell uCloudlink's mobile broadband, or MBB, products and services in the European market. As Europe is preparing to welcome tourists back, need for stable mobile data connectivity while traveling increases accordingly. It is reported that The European Council has updated its list of countries/regions whose citizens and residents should be allowed to travel freely to its 27 member nations, while the UK is also planning to open up international travel for fully vaccinated passengers and resume tourism with more than 150 countries and regions as the vaccination program keeps going.
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KW | Hot Stocks06:09 EDT Kennedy Wilson enters new JV with global institutional investor - Kennedy Wilson has entered into a new joint venture with a global institutional investor to acquire and manage core-plus multifamily communities in the Western U.S. The platform was seeded with an $800M portfolio, including nine multifamily properties located in the Western U.S. that were previously wholly owned by Kennedy Wilson. As part of the transaction, Kennedy Wilson sold a 49% interest in these wholly owned assets to its partner. Kennedy Wilson will continue to have a 51% ownership stake in the new joint venture that will target approximately $700M in additional core-plus acquisition opportunities. The creation of the new platform and the sale of the ownership stake in the multifamily assets generated approximately $254M in proceeds for Kennedy Wilson, which includes $92M of proceeds from refinancing certain assets within the seed portfolio prior to the sale. The majority of these proceeds are expected to be reinvested into new wholly owned acquisitions.
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KYMR | Hot Stocks06:07 EDT Kymera Therapeutics reports 'positive' results from Phase 1 trial of KT-474 - Kymera Therapeutics announced positive interim results from the Single Ascending Dose portion of the Phase 1 clinical trial of KT-474, demonstrating the first degrader proof-of-mechanism in targeted protein degradation in a randomized, placebo-controlled healthy volunteer study. KT-474 has achieved and exceeded the Phase 1 target degradation of 85% within the SAD portion of the Phase 1 trial dosed to date, with profound IRAK4 degradation after a single oral dose that lasted for at least six days at all dose levels. The partial clinical hold on the Multiple Ascending Dose portion of the Phase 1 trial of KT-474 has been lifted following review by the U.S. FDA of interim safety, pharmacokinetic and pharmacodynamic data from the first three cohorts of the SAD healthy volunteer portion of the Phase 1 study. In the SAD portion of the trial, healthy volunteer subjects are randomized 6:2 to either a single oral dose of KT-474 or placebo. Interim data, which also include results from the fourth cohort of the trial, showed dose and time-dependent IRAK4 degradation following single oral KT-474 dose administration. IRAK4 levels were measured in peripheral blood mononuclear cells (PBMC) using mass spectrometry. Following a single KT-474 oral dose, IRAK4 reduction was observed as early as eight hours post-dose, reached maximal reduction at 48 to 72 hours, and was sustained for at least six days with subsequent recovery towards pre-treatment baseline across all dose groups. In the fourth cohort, following a single 300 mg dose of KT-474, median IRAK4 reduction from baseline at 48 hours was 90% compared to a 16% increase in the placebo group, with maximum IRAK4 reduction of 94%, demonstrating proof-of-mechanism for KT-474. KT-474, to date, has demonstrated oral bioavailability, predictable and dose-dependent plasma exposures, and a half-life supportive of oral daily dosing. No treatment-related adverse events have been observed to date.
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SNX | Hot Stocks06:07 EDT Synnex enters agreement with SDV Solutions - SDV Solutions announced it has entered into an agreement with Synnex. Under this agreement, Synnex will provide its resellers with SDV Solutions' third party multi-vendor, or TPM, support and hardware maintenance tailored to fit any Federal Government agency's requirements.
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KBR | Hot Stocks06:06 EDT KBR awarded contract by Raizen Argentina for modernizing FCC unit - KBR announced that it has been awarded a contract by Raizen Argentina for modernizing the Fluid Catalytic Cracking, or FCC, unit at its Buenos Aires Refinery. Under the terms of the contract, KBR will provide a basic engineering package for the FCC New Configuration Project. KBR will offer its reaction and catalyst regeneration technologies that will enable Raizen to achieve higher unit profitability, enhanced on-stream availability and a lower carbon footprint.
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CAE LHX | Hot Stocks06:04 EDT CAE gets approval to acquire L3Harris Technologies military training business - CAE (CAE)announced that it has received all the required regulatory approvals for the previously announced acquisition of L3Harris Technologies' (LHX) military training business for $1.05B subject to customary adjustments and expects closing to be complete on July 2. The company said, "The acquisition of L3Harris' Military Training business will expand CAE's position as a platform-agnostic training and simulation company serving the global defence and security market. The L3Harris Military Training business, which includes Link Simulation & Training, Doss Aviation and AMI, will be integrated with CAE USA. This will approximately double CAE's core military training business in the United States. The Acquisition will also serve to broaden CAE's ability to provide training and operational support solutions across multi-domain operations by diversifying CAE's training and simulation leadership in the air domain, complementing land and naval training solutions, and enhancing CAE's capabilities in space and cyber."
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FAT | Hot Stocks06:01 EDT Fat Brands to acquire Global Franchise Group for $442.5M - Fat Brands announced that it has agreed to acquire Global Franchise Group, which franchises and operates a portfolio of five quick service restaurant concepts, Round Table Pizza, Great American Cookies, Hot Dog on a Stick, Marble Slab Creamery and Pretzelmaker, from Serruya Private Equity, Inc. and Lion Capital LLP, for $442.5M in cash and stock. The cash portion of the purchase price will be funded from the issuance of a new series of notes and cash on hand. The company will also issue to the sellers $25 million in common stock and $67.5M in Series B cumulative preferred stock. The transaction is expected to close by the end of July 2021, subject to expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. With the acquisition of GFG, FAT Brands will have more than 2,000 franchised and company owned restaurants around the world with combined annual system-wide sales of approximately $1.4B. Approximately 87% of GFG's stores are located in the United States. Based on current projections and assumptions, including realization of expected synergies and return to pre-COVID restaurant sales, the acquisition is expected to eventually increase annual EBITDA by approximately $40M to approximately $55M-$60M.
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CEO | Hot Stocks05:37 EDT Cnooc commences production of Weizhou 11-2 oilfield phase II project - Cnooc announced that Weizhou 11-2 oilfield phase II project has commenced production. The Weizhou 11-2 oilfield phase II project is located in Beibu Gulf in the South China Sea with water depth of about 40 meters. In addition to fully utilizing the existing processing facilities of Weizhou 11-2 oilfield, the project has built one unmanned wellhead platform. A total of 13 development wells are planned, including seven production wells and six water injection wells. The project is expected to reach its peak production of approximately 6,000 barrels of crude oil per day in 2022. Cnooc holds 100% interest in Weizhou 11-2 oilfield phase II project and acts as the operator.
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ORPH | Hot Stocks05:35 EDT Orphazyme announces two thirds reduction of workforce in restructuring - Orphazyme announced a restructuring intended to enable the company to advance its corporate strategy and the development of arimoclomol for Niemann-Pick disease type C, or NPC. The resulting cost savings include an approximate two thirds reduction in its global workforce. Orphazyme remains committed to pursuing regulatory approval in Europe and assessing a path forward for arimoclomol in the U.S. following receipt of a Complete Response Letter from the FDA on June 17. As part of the restructuring, Orphazyme will significantly scale back its global organization, including teams based in the U.S. and Europe, with the purpose of reducing the number of employees to those who will support essential activities moving forward. This includes pursuing regulatory approval in Europe, assessing the path forward in partnership with the FDA in the U.S., and supporting the existing global Expanded Access Program. In Denmark, Orphazyme will immediately initiate negotiations under the Danish Act on Collective redundancies and the Act on Information and Consultation. Further, Remi Droller, Martijn Kleijwegt, and Anders Hedegaard will resign from the board of directors effective June 30. The board of directors will thereafter consist of Georges Gemayel, chairman, Bo Jesper Hansen, deputy chairman, Carrolee Barlow, Martin Bonde, Catherine Moukheibir, and Stephanie Smith Okey.
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MCFE SSNLF | Hot Stocks05:31 EDT McAfee extends partnership with Samsung - McAfee (MCFE) announced an extension of its partnership with Samsung (SSNLF) to protect consumers' personal data against online threats. Since 2017, McAfee has provided cross-device security to Samsung PC users worldwide via consumer security by McAfee LiveSafe. With this extension, Samsung PC users will be protected by McAfee LiveSafe from the time they turn on their device.
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REGN SNY | Hot Stocks05:30 EDT Regeneron, Sanofi announce EMA to update Dupixent SmPC - Regeneron (REGN) and Sanofi (SNY) announced that the European Medicines Agency will update the Dupixent summary of product characteristics, or SmPC, adding long-term safety results for adults with moderate-to-severe atopic dermatitis based on an opinion by the Committee for Medicinal Products for Human Use, or CHMP. Data from a single-arm Phase 3 open label extension, or OLE, trial showed the long-term safety profile in adults with atopic dermatitis observed up to three years was generally consistent with what was observed in the controlled pivotal Phase 3 trials. The OLE trial assessed the long-term safety of Dupixent 300 mg weekly in adults who had previously participated in controlled Dupixent trials or had been screened for a Phase 3 trial. The approved Dupixent dose in adults is 300 mg every other week.
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EXEL IPSEY | Hot Stocks05:28 EDT Exelixis, Ipsen announce COSMIC-312 trial meets one primary endpoint - Exelixis (EXEL) and Ipsen (IPSEY) announced that COSMIC-312, the ongoing phase 3 pivotal trial evaluating cabozantinib in combination with atezolizumab versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma, or HCC, met one of the primary endpoints, demonstrating improvement in progression-free survival, or PFS, at the planned primary analysis. A prespecified interim analysis for the second primary endpoint of overall survival, or OS, conducted at the same time as the primary analysis for PFS, showed a trend favoring the combination of cabozantinib and atezolizumab, but did not reach statistical significance. Based on the preliminary OS data, Exelixis anticipates that the probability of reaching statistical significance at the time of the final analysis is low. The trial will continue as planned to the final analysis of OS; results are anticipated in early 2022. In the analysis of the primary endpoint of PFS in the PFS intent-to-treat population, cabozantinib in combination with atezolizumab significantly reduced the risk of disease progression or death by 37% compared with sorafenib. Safety for the combination appeared to be consistent with the known safety profiles of the individual medicines, and no new safety signals were identified. Exelixis plans to discuss the trial results and next steps for a potential regulatory filing with the FDA.
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LU | Hot Stocks05:24 EDT Lufax subsidiary establishes strategic partnership with Schroders subsidiary - Lu International, a subsidiary of Lufax, announced that it has established a strategic partnership with Schroders Singapore, a wholly owned subsidiary of Schroders, an asset management company, to co-innovate digital wealth solutions in Southeast Asia with the aim of addressing the needs of retail investors in the region. The partnership aims to drive innovation in digital wealth solutions, leveraging data analytics to enhance the design of customized multi-asset solutions infusing goals, thematics and sustainability investing for a spectrum of clients in Southeast Asia.
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NOK VOD | Hot Stocks05:22 EDT Nokia, Vodafone Turkey complete clear-channel IP interface trial - Nokia (NOK) announced it has successfully completed a trial with Vodafone (VOD) Turkey, linking Asia and Europe with the first intercontinental 1 terabit clear-channel IP interface. The network capacity is part of an ongoing modernization effort for Vodafone Turkey's IP architecture. Using Nokia's 7950 XRS routers with terabit interfaces powered by Nokia's FP4 chipset, the two companies could scale up the capacity of Vodafone Turkey's IP network in support of next generation applications and access technologies. Nokia's FP4 terabit linecard offers two 1T ports and demonstrated deployment readiness by carrying test traffic on Vodafone Turkey's network.
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ORPH | Hot Stocks05:19 EDT Orphazyme announces 24-month interim results for arimoclomol treatment - Orphazyme announced 24-month interim results of an open-label extension, or OLE, trial, providing efficacy and safety data for its investigational treatment arimoclomol in Niemann-Pick disease type C, or NPC, for up to 36 months. The data are featured in a presentation as part of the Parseghian Scientific Conference for Niemann-Pick disease type C Research. The results demonstrate that arimoclomol provided a sustained benefit to study participants by reducing NPC progression as measured by the five-domain NPC Clinical Severity Scale, or 5D-NPCCSS. A slowing of progression from baseline was observed through 36 months in participants who received arimoclomol from the start of the double-blind phase. By comparison, disease progression among NPC patients receiving routine clinical care was estimated to be a mean increase of 5.2 points after three years, based on a statistical model combining placebo data from the NPC-002 double-blind study and prospective data from the observational NPC-001 study. The effect was consistent across pre-specified subgroups, including among participants more than four years of age and those treated with miglustat. Also, slowing of progression through 24 months was observed in those participants who initiated arimoclomol treatment upon entering the open-label period. Arimoclomol demonstrated a consistent safety profile throughout the 36-month treatment period. Adverse events observed during the open label extension phase were similar to those observed in the double-blind phase. A total of 41 patients joined the OLE following the double-blind period; 33 have now completed up to 36 months of treatment. Data from the 36-month period support the findings from the 12-month double-blind period, which showed a clinically meaningful difference on the 5-domain NPCCSS, with a significant p-value of 0.046. Orphazyme continue to pursue regulatory approval in Europe and evaluate a path forward for arimoclomol in NPC in the US.
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NVDA... | Hot Stocks05:15 EDT Nvidia, Google Cloud partner to establish AI-on-5G Innovation Lab - Nvidia (NVDA) announced that it is partnering with Google Cloud (GOOGL) to establish the industry's first AI-on-5G Innovation Lab, enabling network infrastructure players and AI software partners to develop, test and adopt solutions that will help accelerate the creation of smart cities, smart factories and other advanced 5G and AI applications. The lab will provide enterprises with access to Google Cloud's Anthos platform and Nvidia accelerated computing hardware and software platforms that let them harness data and AI. The companies will begin development in the second half of the year. Nvidia announced in April it is teaming with Google Cloud, Fujitsu, Mavenir, Radisys and Wind River to develop solutions for Nvidia's AI-on-5G platform. Google Cloud is extending the Anthos application platform to the network edge, allowing telecommunications service providers and enterprises to deliver new services and applications at the 5G edge.
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SLGL | Hot Stocks05:08 EDT Sol-Gel Technologies, Galderma enter license agreements for Epsolay and Twyneo - Sol-Gel Technologies and Galderma announced they have signed two exclusive five-year license agreements for the commercialization of Epsolay and Twyneo in the United States. Under these agreements, Galderma has an exclusive license to commercialize Sol-Gel's advanced investigational drug products using Sol-Gel's proprietary micro-encapsulation technology, in each case provided the product is approved by the FDA: Epsolay is under investigation for the treatment of inflammatory lesions of rosacea in adults, with a Prescription Drug User Fee Act, or PDUFA, goal date originally set for April 26. Action on the NDA for Epsolay has not yet been taken due to the inability of the FDA to conduct a pre-approval inspection of the production site of Epsolay due to COVID-19 travel restrictions. Twyneo is under investigation for the treatment of acne vulgaris with a PDUFA goal date set for August 1. Sol-Gel is entitled to up to $15M in upfront payments and regulatory approval milestone payments assuming 2021 approval of both products. Sol-Gel is also eligible to receive tiered double-digit royalties ranging from mid-teen to high-teen percentage of net sales as well as up to $9M in sales milestone payments.
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SFRGY BURBY | Hot Stocks05:00 EDT Salvatore Ferragamo says Marco Gobbetti to join as CEO - Salvatore Ferragamo (SFRGY) announced that an agreement has been reached with Marco Gobbetti to join the company as General Manager and Chief Executive Officer. Gobbetti is the current CEO of Burberry (BURBY). Marco Gobbetti will take up the position as soon as he is released from his contractual obligations, Ferragamo said in a statement.
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BURBY | Hot Stocks04:58 EDT Burberry announces resignation of CEO Marco Gobbetti - Burberry announced that Marco Gobbetti has notified the board of his intention to step down as Chief Executive Officer and leave the company at the end of 2021. Marco will be stepping down after nearly five years with the company to take up another opportunity "that will enable him to return to Italy and be closer to his family," Burberry said in a statement. The board will now begin the search for a successor. It anticipates Gobbetti will remain with Burberry until the end of the calendar year.
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