Stockwinners Market Radar for June 26, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

TRIL

Hot Stocks

18:30 EDT Trillium Therapeutics joins Russell 2000, 3000 Indices - Trillium Therapeutics joins the broad-market Russell 2000 and 3000 Indices effective after the US market opens on June 28. Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of May 7, ranking them by total market capitalization. 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. "Trillium's inclusion in the Russell 2000 index marks an important milestone in the Company's evolution. After a major turnaround in 2020 and an ambitious Phase 1b/2 program announced in April 2021, Trillium is well positioned as a leader in the CD47 space," said Jan Skvarka, President and CEO. "We look forward to sharing our story with a broader base of institutional investors over the coming months."
OG

Hot Stocks

18:01 EDT Onion Global, Sunwah Chuanyu establish JV targeting Southwest China - Onion Global announced that it has entered into a strategic partnership with Sunwah Chuanyu, the Sichuan Area Branch of Sunwah Group to establish a joint venture Xinyang Wujie. The joint venture will target new consumer opportunities in Southwest China, and aims to boost cross-border e-commerce in the region with the mission of "cross-promoting local Sichuan goods to overseas markets, and bringing international goods to Sichuan." Currently, Xinyang Wujie has successfully introduced and incubated the first collection of premium international brands. Cong Li, Founder and CEO of Onion Global, commented, "Southwest China is a rapidly evolving market that presents us with many new growth drivers and business opportunities. The changing consumer behaviors and overall progression towards a higher quality of living and healthier lifestyle will continue to drive the economic growth, leading to massive, untapped market opportunities for us. Only the brands that have effectively integrated global supply chains, high-quality distribution resources, and elevated their operational efficiencies will be able to remain competitive and continue to gain market share to reshape their brand's landscape moving forward."
LMT

Hot Stocks

17:08 EDT Lockheed Martin awarded $735.9M Navy contract modification - Sikorsky Aircraft, a Lockheed Martin company, was awarded a $735.9M modification to previously awarded firm-fixed-price contract. This modification increases the scope for nine Lot Five low rate initial production CH-53K heavy-lift aircraft and associated aircraft, programmatic and logistical support. Work is expected to be completed in December 2024. FY21 aircraft procurement funds in the amount of $735.9M will be obligated at time of award, none of which will expire at the end of the current fiscal year. The Naval Air Systems Command is the contracting activity.
GCMG

Hot Stocks

17:01 EDT GCM Grosvenor added to Russell 2000 Index - GCM Grosvenor announced that it joined the Russell 2000 Index after the equity markets closed today as part of the 2021 Russell indexes reconstitution. The new index will be effective at the opening of U.S. equity markets on June 28, 2021. "Our inclusion in the Russell 2000(R) Index is the latest milestone in the firm's 50-year history, following our successful transition to a public company last year," said Michael Sacks, Chairman and Chief Executive Officer of GCM Grosvenor. "We look forward to continuing to deliver value to our clients and shareholders." Membership in the Russell 2000 Index, which remains in place for one year, is based on membership in the broad-market Russell 3000 Index. The stock also was automatically added to the appropriate growth and value indexes.
ECL

Hot Stocks

16:30 EDT Ecolab's Industrial segment announces price increases - Ecolab Inc. announced that its Industrial segment is implementing price increases for all Industrial segment divisions, effective immediately or as contracts permit. The need for these price increases is driven by the continued and significant escalation of energy and raw material costs, tightening availability of raw materials and rising packaging, transportation, personnel and utility costs. Pricing for most Industrial segment programs will increase between 9% and 15%. Price increases will vary by country and industry, driven by local cost increases.
COTY

Hot Stocks

16:21 EDT Coty Chief Supply Officer Richard Jones leaving the company - Coty announced that Richard Jones is stepping down from his role as Chief Supply Officer and Head of R&D. Jones, who joined Coty in 2019, will remain with Coty until June 30. The company intends to separate Jones' role into two positions, appointing an expert leader over each of Supply Chain and R&D. These new appointments will be announced in due course. In the interim, current Coty leaders will be assuming Jones' responsibilities.
IMAX

Hot Stocks

16:19 EDT Imax announces 12-month extension to share repurchase program - Imax announced a 12-month extension to the company's share-repurchase program through June 30, 2022. The current share-repurchase program authorized the company to repurchase up to $200M of its common shares, of which approximately $89.4M remains available, and was set to expire on June 30. With this extension effective July 1, the company remains authorized to repurchase up to approximately $89.4M worth of common shares through June 30, 2022. In light of the current operating environment, the company does not currently intend to repurchase shares.
OCFC

Hot Stocks

16:07 EDT OceanFirst Financial announces stock repurchase program - OceanFirst Financial Corp. announced the authorization of the board of the 2021 stock repurchase program to repurchase approximately 5% of the company's outstanding common stock up to an additional 3M shares. This amount is in addition to the remaining 1.52M shares available under the existing 2019 stock repurchase program.
SO

Hot Stocks

16:05 EDT Georgia Power says Vogtle Unit 3 hits normal operating pressure during testing - Georgia Power announced Vogtle Unit 3 plant systems have successfully reached normal operating pressure and temperature during hot functional testing. Over the next several weeks, plant systems will continue to be tested at normal operating pressure and temperature. Hot functional testing started on April 25 and marks the last series of major tests for the new nuclear unit ahead of fuel load. The testing represents a significant step towards operations and providing customers with a reliable, carbon-free energy source for the next 60 to 80 years.
MSFT

Hot Stocks

15:44 EDT Microsoft investigating malicious actor distributing malicious drivers in gaming - Microsoft said in post to it security response blog: "Microsoft is investigating a malicious actor distributing malicious drivers within gaming environments. The actor submitted drivers for certification through the Windows Hardware Compatibility Program. The drivers were built by a third party. We have suspended the account and reviewed their submissions for additional signs of malware. We have seen no evidence that the WHCP signing certificate was exposed. The infrastructure was not compromised. In alignment with our Zero Trust and layered defenses security posture, we have built-in detection and blocking of this driver and associated files through Microsoft Defender for Endpoint. We are also sharing these detections with other AV security vendors so they can proactively deploy detections. The actor's activity is limited to the gaming sector specifically in China and does not appear to target enterprise environments. We are not attributing this to a nation-state actor at this time. The actor's goal is to use the driver to spoof their geo-location to cheat the system and play from anywhere. The malware enables them to gain an advantage in games and possibly exploit other players by compromising their accounts through common tools like keyloggers." Reference Link
BAC...

Hot Stocks

15:34 EDT Fed extends Paycheck Protection Program Liquidity Facility for 'final time' - The Federal Reserve Board announced it will extend for "a final time" its Paycheck Protection Program Liquidity Facility, or PPPLF, by an additional month to July 30, 2021. "The extension is being made as an operational accommodation to allow additional processing time for banks, community development financial institutions, and other financial institutions to pledge to the facility any Paycheck Protection Program, or PPP, loans approved by the Small Business Administration through the June 30 expiration of the PPP program. The PPPLF extends term credit to financial institutions making PPP loans, accepting the PPP loans as collateral. The liquidity provided by the PPPLF bolsters the effectiveness of the PPP by helping eligible financial institutions fund PPP loans. The PPPLF was established in April 2020 under the Board's 13(3) authority and the extension from June 30 to July 30, 2021, was approved by the Secretary of the Treasury," the Fed said. Publicly traded U.S. money center banks include Bank of America (BAC), Citi (C), Goldman Sachs (GS), JPMorgan (JPM), Morgan Stanley (MS), U.S. Bancorp (USB) and Wells Fargo (WFC).
FIII ELMS

Hot Stocks

15:23 EDT Electric Last Mile Solutions closes deal, expects to trade as 'ELMS' on June 28 - Electric Last Mile and Forum Merger III Corporation (FIII) announced the completion of the companies' previously announced business combination, which was approved by Forum stockholders on June 24. The merger has resulted in Electric Last Mile Solutions, a pure-play commercial electric vehicle company, becoming a publicly traded company and its common stock and warrants are expected to begin trading on the Nasdaq Stock Market under the ticker symbols "ELMS" and "ELMSW", respectively, on June 28. "The ELMS Urban Delivery, anticipated to launch later this year, is expected to be the first Class 1 commercial electric vehicle available in the U.S. market and will be produced at the Company's facility in Mishawaka, Indiana. The Urban Delivery is anticipated to have a range of approximately 150 miles and is also expected to come with a suite of connectivity and productivity solutions, including over-the-air updates. As part of its integrated business model, ELMS also plans to offer upfitting solutions to customize the Urban Delivery to fleets' individual end-use cases. ELMS also recently announced plans to reveal a working prototype of its second vehicle, the Urban Utility, an all-electric medium duty cab forward truck, later this summer," the company stated.
HCDI

Hot Stocks

14:18 EDT Harbor Custom Development contracts to purchase 112 unit condominium site - Harbor Custom Development announced that it has entered into a purchase and sale agreement for the acquisition of approximately 2.34 acres of land for the construction of 112 condominium units in Burien, Washington for $2.6M. The purchase is expected to close on or before September 3.
TOSBF TOSYY

Hot Stocks

14:00 EDT Toshiba stakeholders oust Osamu Nagayama as chairperson - Toshiba Corporation announced that the newly elected Board of Directors of Toshiba has issued a statement. The full text of the statement is as follows: "The newly elected Board of Directors of Toshiba Corporation acknowledges and respects the outcome of the vote at the Company's Annual General Meeting of Shareholders today. Listening to shareholders' concerns and responding to them is a critical responsibility of the Board. Toshiba is in the middle of a period of considerable change, focused around an improvement in corporate governance, greater emphasis on capital management, increase in shareholder returns, and the rebuilding of trust and support from our shareholders. The Board of Directors has undergone considerable change as a result of the independent investigation report published on June 10th, 2021 and the voting at the Annual General Meeting this afternoon. Today, the Board unanimously elected Satoshi Tsunakawa as Interim Chairperson of the Board. Mr. Tsunakawa brings to this role a deep understanding of Toshiba's strategic capabilities and competitive advantages, as well as an objective view of its challenges and opportunities. Mr. Tsunakawa will provide stability for our customers and employees while enabling the Board to advance its commitment to constructive change. The Board has resolved on a new composition of all board committees, focused on the skills and capabilities of the current members of the board. In the coming weeks, the Nomination Committee and other members of the Board and management will engage with Toshiba's major stakeholders-our shareholders, management, employees and customers- to consider any additional changes that may be needed to achieve the best possible outcome for Toshiba's stability, governance and future profitability."
VRTX

Hot Stocks

13:47 EDT Vertex Pharmaceuticals announces new portfolio reimbursement agreement in Italy - Vertex Pharmaceuticals announced it has reached a new portfolio agreement with the Italian Medicines Agency, AIFA, for the reimbursement of all of Vertex's approved medicines for the treatment of cystic fibrosis, or CF, including Kaftrio in a combination regimen with ivacaftor. Italian patients ages 12 years and older with one F508del mutation and one minimal function mutation or two F508del mutations in the cystic fibrosis transmembrane conductance regulator gene will now have access to Kaftrio in a combination regimen with ivacaftor. Additionally, under the terms of the agreement, eligible patients ages two years and older with CF who have two copies of the F508del mutation in the CFTR gene will now have access to Orkambi. Eligible patients ages 12 years and older who either have two copies of the F508del mutation, or one copy of the F508del mutation and another responsive residual function mutation in the CFTR gene, will have broad access to Symkevi in combination with ivacaftor. The agreement also expands access to Kalydeco for eligible patients ages one year and older. In addition, the agreement covers any new approved indication extensions for Vertex's CF medicines submitted and approved for reimbursement during the term of the contract.
SNPX

Hot Stocks

13:39 EDT Synaptogenix jumps after CSO speaks on TD Ameritrade Network - Previously, Synaptogenix announced that Dr. Daniel Alkon, the company's President and Chief Scientific Officer, will appear as a featured guest on TD Ameritrade Network's "The Watch List" on Friday, June 25, at 1:20pm ET. "Dr. Alkon will discuss the progression of treatments for Alzheimer's disease ("AD"), the regenerative mechanism of action for Synaptogenix's lead drug, Bryostatin-1, and how the recently approved drug from Biogen may impact future treatments in the AD space," the company said ahead of the CSO's planned appearance. In afternoon trading, shares of Synaptogenix have jumped $2.08, or 19%, to $13.10. Reference Link
GFSZY

Hot Stocks

13:34 EDT DOJ says G4S to plead guilty for role in conspiracy to rig bids - G4S Secure Solutions NV, a Belgian security firm, has agreed to plead guilty for its role in a conspiracy to rig bids, allocate customers and fix prices for defense-related security services, including a multimillion-dollar contract issued in 2020 to provide security services to the U.S. Department of Defense for military bases and installations in Belgium, the Department of Justice stated. "This is the first international resolution obtained by the Procurement Collusion Strike Force," the DOJ said. "In addition to agreeing to plead guilty, G4S has agreed to pay a criminal fine of $15 million. The company began cooperating with the United States in April 2020 and will continue to cooperate in the ongoing investigation. The plea agreement is subject to court approval," the DOJ added. Reference Link
RCL

Hot Stocks

13:22 EDT Two Royal Caribbean guests under 16 tested positive for Covid - Royal Caribbean announced that two guests on Adventure of the Seas tested positive for Covid-19 after routine testing that is required before returning home. The company said, "Both guests, under the age of 16 and unvaccinated, were immediately quarantined. One guest is asymptomatic, and the other guest is experiencing mild symptoms. Those in their immediate travel party are vaccinated and have tested negative. Close contacts were quickly identified and tested. All are vaccinated and tested negative. The guests and their travel party disembarked today in Freeport, The Bahamas and are on their way home to Florida. Ninety-two percent of our guests on Adventure are fully vaccinated and the remaining 8% are under 16 years old. One hundred percent of our crew are fully vaccinated." Shares of Royal Caribbean are up 2% to $88.43 in afternoon trading.
RDFN

Hot Stocks

13:02 EDT Redfin Demand Index falls below 2020 levels for first time in 2021 - Redfin announced that its Homebuyer Demand Index, a measure of requests for home tours and other home-buying services from Redfin agents, has fallen below 2020 levels for the first time this year. It was 1% year over year for the week ending June 20. "As a result of declining sales, the active supply of homes for sale has crept up 5% from the 2021 low in mid-March. However, home prices are still rising, homes are selling in fewer days than ever and more homes than ever are selling above list price. These indicators will take longer to reflect a slowdown since they are based on homes that went under contract a month or two ago," the company said in a statement.
BKR

Hot Stocks

13:02 EDT Baker Hughes reports U.S. rig count flat at 470 rigs - Baker Hughes reports that the U.S. rig count is unchanged from last week at 470 with oil rigs down 1 to 372, gas rigs up 1 to 98, and miscellaneous rigs unchanged at 0. The U.S. Rig Count is up 205 rigs from last year's count of 265, with oil rigs up 184 gas rigs up 23 and miscellaneous rigs down 2. The U.S. Offshore Rig Count is up 1 to 14, up 3 year-over-year. The Canada Rig Count is up 9 from last week to 126, with oil rigs up 8 to 82, gas rigs up 1 to 44. The Canada Rig Count is up 113 rigs from last year's count of 13, with oil rigs up 78, gas rigs up 35.
BKR

Hot Stocks

13:01 EDT Baker Hughes reports U.S. rig count flat at 470 rigs
XELA

Hot Stocks

13:01 EDT Court grants Exela Technologies' motion to dismiss class action lawsuit - Exela Technologies announced that U.S. District Judge Sydney A. Fitzwater has granted Exela's motion to dismiss in its entirety the Texas federal securities class action suit filed March 2020. Plaintiffs have the option to file an amended complaint correcting the deficiencies set forth in the Court's June 24 dismissal order by August 5.
REGN LLY

Hot Stocks

12:59 EDT U.S. 'immediately pausing' distribution of Lilly's Covid monoclonal antibodies - The Assistant Secretary for Preparedness and Response and the Food and Drug Administration within the Department of Health and Human Services said they are "immediately pausing" all distribution of Eli Lilly's bamlanivimab and etesevimab together and etesevimab alone on a national basis "until further notice." In addition, FDA recommends that health care providers nationwide use alternative authorized monoclonal antibody therapies and not use bamlanivimab and etesevimab administered together at this time. The Centers for Disease Control and Prevention has identified that the combined frequencies of the SARS-CoV-2 P.1/Gamma variant and the B.1.351/Beta variant throughout the United States now exceed 11% and are trending upward. Results from in vitro assays that are used to assess the susceptibility of viral variants to particular monoclonal antibodies suggest that bamlanivimab and etesevimab administered together are not active against either the P.1 or B.1.351 variants, the agencies said in a statement. REGEN-COV and sotrovimab are alternative monoclonal antibody therapies that are currently authorized for the same use as bamlanivimab and etesevimab administered together, they added. Reference Link
DKNG

Hot Stocks

12:59 EDT Florida authorizes sports, event betting at venues via online betting platforms - Florida has authorized sports and event betting under Florida law at "professional sports venues and pari-mutuel facilities and statewide via online sports betting platforms by entities authorized to conduct online sports betting, and by Native American tribes with a Florida gaming compact, only for persons age 21 years or older," according to a statement. The statement goes on to say that it "Requires legislative action to regulate sports betting. Legislature may tax betting revenues, and all such taxes are required to supplement the Educational Enhancement Trust Fund." Reference Link
AZN

Hot Stocks

12:12 EDT AstraZeneca reports exenatide Phase 3 trial in adolescents met primary endpoint - Results from a Phase 3 pivotal trial showed AstraZeneca's exenatide extended-release 2mg once weekly significantly reduced blood sugar-as measured by HbA1c-versus placebo in adolescents aged 10-17 with type 2 diabetes, or T2D, the company announced. "This Phase III trial is the first and only completed trial of a once-weekly glucagon-like peptide-1 receptor agonist in adolescents aged 10-17 with T2D. The results were presented today at the 2021 American Diabetes Association Virtual 81st Scientific Sessions," the company noted. The trial met its primary endpoint, demonstrating that exenatide once weekly significantly reduced HbA1c from baseline compared with placebo at 24 weeks, with least squares mean changes of -0.36% and +0.49%, respectively and a between-group LS mean difference of -0.85%. Data at week 24 also showed that exenatide once weekly was generally well tolerated and consistent with the existing safety profile in adults. The most common adverse events were upper respiratory tract infections and abdominal pain. Gastrointestinal disorders were reported less frequently in the exenatide once weekly group than in the placebo group.
FSR

Hot Stocks

12:06 EDT Fisker CEO notes 'something to check out this weekend' - Fisker Chairman and CEO Henrik Fisker said via Twitter: "Something to check out this weekend ; going live in 5 minutes: see http://Fiskerinc.com !" Reference Link
YPF

Hot Stocks

12:00 EDT YPF falls -9.0% - YPF is down -9.0%, or -47c to $4.75.
AGRO

Hot Stocks

12:00 EDT Adecoagro falls -9.3% - Adecoagro is down -9.3%, or -$1.05 to $10.31.
AGTI

Hot Stocks

12:00 EDT Agiliti falls -9.8% - Agiliti is down -9.8%, or -$2.30 to $21.17.
XYF

Hot Stocks

12:00 EDT X Financial rises 22.5% - X Financial is up 22.5%, or $2.60 to $14.16.
EXPR

Hot Stocks

12:00 EDT Express rises 24.7% - Express is up 24.7%, or $1.42 to $7.13.
SPCE

Hot Stocks

12:00 EDT Virgin Galactic rises 32.8% - Virgin Galactic is up 32.8%, or $13.22 to $53.48.
MPC CAPL

Hot Stocks

11:52 EDT Marathon, 7-Eleven agree to divest hundreds of stores, FTC announces - 7-Eleven and Marathon Petroleum Corporation (MPC) have agreed to divest hundreds of stores used to sell gasoline and diesel fuel in 293 local markets across 20 states to settle Federal Trade Commission charges that 7-Eleven's acquisition of Marathon's Speedway subsidiary violated federal antitrust laws, the FTC announced. 7-Eleven consummated the acquisition on May 14, "even though the company knew the acquisition violated Section 7 of the Clayton Act and Section 5 of the FTC Act," the FTC stated. Under the terms of the proposed consent order, 7-Eleven, Inc. and Marathon are required to divest 124 retail fuel outlets to Anabi Oil, comprising 123 Speedway outlets and one 7-Eleven outlet. They are also required to divest 106 retail fuel outlets to Cross America Partners (CAPL), comprising 105 Speedway outlets and one 7-Eleven outlet. And they must divest 63 Speedway retail fuel outlets to Jacksons Food Stores. In addition, to remove impediments that could prevent the buyers from competing vigorously in these markets, the proposed order also prohibits 7-Eleven from enforcing any noncompete provisions as to any franchisees or employees working at or doing business with the divested assets. The proposed order also requires 7-Eleven, Inc. and Marathon, for a period of five years, to obtain prior Commission approval before purchasing any of the divested outlets. For 10 years, the companies must provide prior notice of future acquisitions of the divested assets and other assets identified by the Commission within the 293 local markets at issue, plus an additional three markets. Reference Link
MNKD

Hot Stocks

11:38 EDT MannKind to present posters on 923-P in Diabetes, 722-P in clinical therapeutics - MannKind Corporation will present two posters at the American Diabetes Association's virtual 81st Scientific Sessions, June 25-29. The submissions include 923-P in Pediatrics-Type 1 Diabetes, and 722-P in Clinical Therapeutics/New Technology-Insulins. MannKind is also hosting a booth in the virtual Exhibit Hall at the Scientific Sessions. An insulin regimen that closely mimics physiologic insulin for pediatric patients with type 1 diabetes remains a critical goal. Poster 923-P reports on a Phase 2 clinical study to characterize the pharmacokinetics and safety of prandial Afrezza in 30 children aged 8 to 17 years with T1D. Afrezza - an ultra rapid-acting dry-powder prandial insulin - is currently indicated to improve glycemic control in adults with T1D or type 2 diabetes. "The final results from the phase 2 pediatric study revealed that serum insulin concentrations peaked rapidly within 10-15 minutes of inhaled administration of TI, similar to the results observed previously in adults. In addition, there were no severe hypoglycemic events or clinically relevant declines in pulmonary function, and no new or unexpected signals with TI," said Dr. Kevin Kaiserman, Vice President, Medical Affairs and Safety of MannKind and the presenting author of the study. "The pharmacokinetics and safety results provide us the rationale to move forward with conducting a phase 3 safety and efficacy study in pediatric patients with diabetes, which we expect to initiate in the fall." Poster 722-P presents a retrospective analysis of data from the Levin study, an investigator-initiated trial sponsored by MannKind, to determine the effect of prandial inhaled insulin on daytime glucose levels in people with uncontrolled type 2 diabetes. For purposes of the study, daytime was defined as 6:00 am to midnight. Twenty T2D patients who had never been on mealtime insulin before were started on TI and rapidly titrated during the first week and followed for 12 weeks. On average, patients showed an 83.5% increase in daytime time-in-range. The study concluded that TI reduced patients' daytime time spent in hyperglycemia by 76.4% and without a significant increase in daytime time spent in hypoglycemia.
LLY

Hot Stocks

11:37 EDT Eli Lilly says tirzepatide beat semaglutid in body weight reductions - Eli Lilly announed that tirzepatide led to superior A1C and body weight reductions from baseline compared to injectable semaglutide 1 mg in 40-week results from its SURPASS-2 clinical trial, which were simultaneously published today in The New England Journal of Medicine. These results showed that all three tirzepatide doses achieved greater A1C and weight reductions compared to semaglutide, the company said in a statement. Additionally, a prespecified exploratory composite endpoint comprised of participants who achieved an A1C level less than or equal to 6.5% and weight loss of 10% or greater, while not experiencing hypoglycemia less than 54 mg/dL or severe hypoglycemia, was evaluated. Across the three doses of tirzepatide, 32%, 51% and 60% of participants achieved this composite endpoint compared to 22% of participants taking semaglutide 1 mg. The overall safety profile of tirzepatide was similar to the glucagon-like peptide-1 receptor agonist class, according to Lilly. SURPASS-2 was a 40-week, randomized, open-label trial comparing the efficacy and safety of tirzepatide to semaglutide as an add-on to metformin in adults with type 2 diabetes. The study randomized 1,879 participants, who had a mean duration of diabetes of 8.6 years, a baseline A1C of 8.28 percent and a baseline weight of 93.7 kg.
MDGL

Hot Stocks

11:36 EDT Madrigal announces presentation of 'positive' data from MAESTRO-NAFLD-1 study - Madrigal Pharmaceuticals announced the presentation of "positive" clinical data from the open-label portion of its ongoing Phase 3 MAESTRO-NAFLD-1 study of resmetirom at the European Association for the Study of the Liver Annual Meeting, The International Liver Congress 2021, being held virtually, June 23-26. "The data continue to position resmetirom as a promising treatment option for nonalcoholic steatohepatitis - NASH - patients," the company said. At the time of this presentation, in this Phase 3 open label arm of MAESTRO-NAFLD-1, 52 week data was available on 115 non-cirrhotic presumed NASH patients, including safety analyses, various blood chemistry measurements, magnetic resonance imaging proton density fat-fraction, magnetic resonance elastography, and FibroScan. All patients received 100 mg of resmetirom, once-a-day. The study demonstrated rapid and sustained reduction in hepatic fat and fibrosis. Reductions were also observed in multiple liver enzymes, inflammatory biomarkers, LDL cholesterol, and other atherogenic lipids. Resmetirom was safe and well-tolerated with the only adverse event observed at more than 5% frequency being a transient increase in stool frequency in the first two weeks of therapy, about 10% over historical placebo rates, and COVID infection of 6.8%. As seen throughout the resmetirom clinical trial program, no central thyroid axis changes or adverse effects on vital signs were observed. "Based on Phase 2 results, together with the open-label data from the ongoing MAESTRO-NAFLD-1 Phase 3 clinical trial, we remain confident that resmetirom has the potential to become the best-in-class and first-to-market treatment option for patients with NASH, especially those with significant liver fibrosis," said Paul Friedman, M.D., CEO of Madrigal.
ABT

Hot Stocks

11:33 EDT Abbott announces late-breaking data on FreeStyle Libre presented at ADA meeting - Abbott announced late-breaking data that showed FreeStyle Libre "can support health equity through access to more affordable, life-changing technology for Americans living with diabetes, including those in underserved communities." Presented at the American Diabetes Association, or ADA, 81st Scientific Sessions, the data demonstrate meaningful outcomes for people with diabetes using FreeStyle Libre system, including reductions in HbA1C levels, acute diabetes events and all-cause hospitalizations, the company said. In comparative real-world data for U.S.-only matched patient groups, the FreeStyle Libre system was shown to achieve the same health benefits, including reductions in HbA1C levels and acute complications, while being accessible to a greater population of people with diabetes compared to other competitor CGM systems. Demographic data from these studies show that FreeStyle Libre users more closely represent America's diverse type 1 and type 2 diabetes population, including older people, those living in rural areas, people of color and those with higher rates of comorbidities.
UEHPF

Hot Stocks

11:30 EDT Cobham Group says considering possible combination with Ultra Electronics - Cobham Group issued the following "response to media speculation" to the London Stock Exchange: "Following recent media speculation, Cobham Group confirms that it is currently considering a possible combination with Ultra Electronics Holdings plc with a view to creating a global defence electronics champion. Ultra and Cobham both have long heritage as innovators, and share advanced complementary capabilities delivering mission critical solutions to the US, UK and other key allies. A number of structures are under consideration to effect such a combination, including a contribution of Cobham into Ultra in exchange for new Ultra shares or a possible offer for Ultra by Cobham. There can be no certainty that any combination will result, and therefore there is no certainty that an offer will be made for Ultra or Cobham, nor as to the terms on which any such offer will be made. In accordance with Rule 2.6(a) of the Code, Cobham must, by not later than 5.00 p.m. on 23 July 2021 (being 28 days after today's date), either announce a firm intention to make an offer for Ultra in accordance with Rule 2.7 of the Code or announce that it does not intend to make an offer, in which case the announcement will be treated as a statement to which Rule 2.8 of the Code applies. This deadline can be extended with the consent of the Panel on Takeovers and Mergers in accordance with Rule 2.6(c) of the Code. A further announcement will be made in due course."
TOSYY

Hot Stocks

11:08 EDT Toshiba board elects Satoshi Tsunakawa as interim chairman - Toshiba Corporation announced that the newly elected Board of Directors of Toshiba has issued a statement. "The newly elected Board of Directors of Toshiba Corporation acknowledges and respects the outcome of the vote at the Company's Annual General Meeting of Shareholders today. Listening to shareholders' concerns and responding to them is a critical responsibility of the Board. Toshiba is in the middle of a period of considerable change, focused around an improvement in corporate governance, greater emphasis on capital management, increase in shareholder returns, and the rebuilding of trust and support from our shareholders. The Board of Directors has undergone considerable change as a result of the independent investigation report published on June 10th, 2021 and the voting at the Annual General Meeting this afternoon. Today, the Board unanimously elected Satoshi Tsunakawa as Interim Chairperson of the Board. Mr. Tsunakawa brings to this role a deep understanding of Toshiba's strategic capabilities and competitive advantages, as well as an objective view of its challenges and opportunities. Mr. Tsunakawa will provide stability for our customers and employees while enabling the Board to advance its commitment to constructive change."
AMZN

Hot Stocks

10:45 EDT Amazon's AWS acquires encrypted messaging service Wickr - In an AWS Security blog post, the company said, "We're excited to share that AWS has acquired Wickr, an innovative company that has developed the industry's most secure, end-to-end encrypted, communication technology. With Wickr, customers and partners benefit from advanced security features not available with traditional communications services - across messaging, voice and video calling, file sharing, and collaboration. This gives security conscious enterprises and government agencies the ability to implement important governance and security controls to help them meet their compliance requirements...AWS is offering Wickr services effective immediately and Wickr customers, channel, and business partners can continue to use Wickr's services as they do today." Reference Link
T EA

Hot Stocks

10:19 EDT AT&T elects Luis Ubinas to board; board expands to 13 directors - AT&T (T) has elected Luis Ubinas to its board of directors, effective immediately. Ubinas is currently the lead director of Electronic Arts (EA). Ubinas's election brings the number of directors on AT&T's board to 13. He will serve on the board's Public Policy and Corporate Reputation committee.
HFC CVI

Hot Stocks

10:18 EDT HollyFrontier up 3% after Supreme Court rules in renewable fuels case - Shares of HollyFrontier (HFC) are up $1.00, or 3%, to $34.68 while shares of refiner peer CVR Energy (CVI) are up nearly 5%, or 86c, to $19.90.
HFC CVI

Hot Stocks

10:17 EDT Supreme Court rules for HollyFrontier in renewable fuels case - The Supreme Court wrote in a decision posted on its website: "When Congress created the renewable fuel program requiring most domestic refineries to blend renewable fuels into the transportation fuels they produce ... it added features designed to lessen the impact of the program's mandates on small refineries... three small refineries initially received an exemption, saw it lapse for a period, and then again petitioned for an exemption under subparagraph (B)(i). EPA granted the exemptions, and a group of renewable fuel producers objected. The Tenth Circuit vacated EPA's decisions, concluding that the small refineries were ineligible for an "extension" under subparagraph (B)(i) because they had allowed previous exemptions to lapse." The Supreme Court reversed the prior decision, ruling "the respondents have not shown that EPA's approval of the petitioners' extension requests was in excess of the agency's statutory authority. 5 U. S. C. Section706(2)(C). To the extent the court of appeals vacated EPA's orders on this ground, the judgment is reversed." Reference Link
AGRO

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10:00 EDT Adecoagro falls -6.8% - Adecoagro is down -6.8%, or -77c to $10.60.
EDN

Hot Stocks

10:00 EDT Edenor falls -6.8% - Edenor is down -6.8%, or -35c to $4.76.
YPF

Hot Stocks

10:00 EDT YPF falls -8.0% - YPF is down -8.0%, or -41c to $4.80.
SPCE

Hot Stocks

10:00 EDT Virgin Galactic rises 15.9% - Virgin Galactic is up 15.9%, or $6.38 to $46.64.
PSFE

Hot Stocks

10:00 EDT Paysafe rises 17.6% - Paysafe is up 17.6%, or $1.95 to $13.06.
XYF

Hot Stocks

10:00 EDT X Financial rises 28.9% - X Financial is up 28.9%, or $3.34 to $14.90.
BBAR

Hot Stocks

09:47 EDT Banco BBVA Argentina falls -7.5% - Banco BBVA Argentina is down -7.5%, or -27c to $3.34.
YPF

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09:47 EDT YPF falls -8.3% - YPF is down -8.3%, or -43c to $4.79.
DOCS

Hot Stocks

09:47 EDT Doximity falls -9.1% - Doximity is down -9.1%, or -$4.84 to $48.16.
PSFE

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09:47 EDT Paysafe rises 10.1% - Paysafe is up 10.1%, or $1.13 to $12.24.
NKE

Hot Stocks

09:47 EDT Nike rises 13.4% - Nike is up 13.4%, or $17.84 to $151.44.
SPCE

Hot Stocks

09:47 EDT Virgin Galactic rises 18.7% - Virgin Galactic is up 18.7%, or $7.53 to $47.79.
CYT

Hot Stocks

09:46 EDT Cyteir Therapeutics Inc trading resumes
CYT

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09:36 EDT Cyteir Therapeutics Inc trading halted, volatility trading pause
CSSE

Hot Stocks

09:31 EDT Chicken Soup for the Soul Entertainment's Crackle App to launch on TCL - Chicken Soup for the Soul Entertainment announced the agreement to launch an android powered, Crackle-branded application on TCL's service.
XXII

Hot Stocks

09:30 EDT 22nd Century CEO says 'high-value commercial prospects' in reach - 22nd Century Group released an update letter to its shareholders from CEO James Mish. The letter read in part, "We have made incredible progress over the last 12 months and believe even more exciting developments are on the horizon.It is my privilege to tell you that our high-value commercial prospects are in reach. Our commercially focused intellectual property platform provides us with industry-leading technology and a wide R&D moat. Our financial position and operating efficiency are stronger than ever. Shares of 22nd Century have soared over 470% in the past 12 months. In short, we have successfully advanced our strategic initiatives and reinforced a strong financial foundation and long, growth runway, making this an even more exciting time to be involved with 22nd Century. On the political front, recent policy and regulatory developments are generating increasing momentum in our favor as we advance toward our next operational milestones. We have seen renewed interest in and support for a menthol ban on tobacco products, a reduced nicotine mandate requiring that all cigarettes be made "minimally or non-addictive" based on their nicotine content and, with 36 states now legalizing cannabis in some form, major progress on potential reform to hemp/cannabis regulation. There is also growing offshore momentum that has opened near-term opportunities. This grand slam scenario continues to power forward. In our tobacco franchise, I again want to reiterate that we are highly confident that our Modified Risk Tobacco Product application for our VLN brand of reduced nicotine content (RNC) cigarettes is in the final stages of review with the U.S. Food and Drug Administration. 22nd Century offers the FIRST and ONLY reduced nicotine content combustible cigarette product authorized for sale by the FDA, and our pending MRTP authorization will allow us the headline marketing claim that our industry-disrupting cigarettes contain "95% Less Nicotine." Securing this marketing authorization and launching VLN remains my number one priority as CEO. It is our home run scenario which I believe will exponentially increase the market capitalization of our Company. We are fully prepared for the commercial launch of VLN King and VLN Menthol King cigarettes within 90 days of receiving authorization from the FDA. We have expanded our VLN tobacco growing program for the current crop year to support anticipated demand, and last fall we received a new patent on our breakthrough technology that delivers precise genetic control over nicotine levels in virtually any variety of the tobacco plant. The new technology provides 22nd Century with a rapid pathway to introduce reduced nicotine traits into virtually all varieties of tobacco. We have a terrific opportunity in reduced nicotine products across the entire tobacco landscape both in the U.S. and offshore, and these opportunities are already in motion. Turning to hemp/cannabis, after conducting a careful strategic evaluation of this franchise, we refocused our strategy in 2020 to build out and prioritize the more attractive upstream segments of the cannabinoid value chain. We believe that we are now uniquely positioned in the cannabis industry, steeped in plant science and genetic IP critical to quickly develop high-quality, large-scale and stable commercial plant lines. 22nd Century's plant science focus will serve as the critical link to create the specific characteristics needed to optimize cannabis products at scale as the industry evolves toward mass production. Our highly differentiated upstream capabilities are based on patented breakthrough hemp/cannabis technology that allows us to genetically engineer hemp/cannabis plants to modulate their cannabinoid and terpene profiles in a fraction of the time of our competitors. We can tailor the plant's therapeutic qualities, and, in turn, enhance our strategic partner's economics and the consumer's hemp/cannabis experience...The Company is actively pursuing multiple hemp/cannabis revenue streams in 2021. These include monetization of a portion of the Company's valuable hemp/cannabis intellectual property, including the recently announced strategic partnership with Aurora, and offtake commitments for our high CBD and CBG plant lines currently growing in Needle Rock Farms in Colorado for commercialization in the forms of flower, distillate, or isolate. Then additional new plant lines coming through the development pipeline will expand growing and revenue generation opportunities next year."
DSX

Hot Stocks

09:27 EDT Diana Shipping announces time charter contract for M/V Melia - Diana Shipping announced that, through a separate wholly-owned subsidiary, it has entered into a time charter contract with Viterra Chartering B.V., Rotterdam, for one of its Panamax dry bulk vessels, the m/v Melia. The gross charter rate is US$25,750 per day, minus a 5% commission paid to third parties, for a period until minimum April 7, 2022 up to maximum June 7, 2022. The charter commenced retroactively on June 11, 2021. The m/v Melia was chartered, as previously announced, to Ausca Shipping Limited, Hong Kong, at a gross charter rate of US$10,000 per day, plus US$500,000 gross ballast bonus, minus a 5% commission paid to third parties. The "Melia" is a 76,225 dwt Panamax dry bulk vessel built in 2005. The employment of "Melia" is anticipated to generate approximately US$7.65 million of gross revenue for the minimum scheduled period of the time charter.
CIDM

Hot Stocks

09:27 EDT Cinedigm to join Russell Microcap Index - Cinedigm is set to join the Russell Microcap Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens on June 28, according to a preliminary list of additions posted June 4.
FGEN ALPMY

Hot Stocks

09:26 EDT FibroGen, Astellas Pharma receive positive CHMP opinion for EVRENZO - Astellas (ALPMY) and FibroGen (FGEN) announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion relating to the use of roxadustat for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease. CKD impacts one in 10 people globally, of whom one in five are affected by anemia. Anemia of CKD is associated with significant impairment in quality of life and progression to adverse cardiovascular and renal outcomes.4-6 Anemia of CKD is often untreated or not treated to target If approved by the European Commission, roxadustat will be the first orally administered inhibitor of hypoxia-inducible factor prolyl hydroxylase available in Europe. Roxadustat increases hemoglobin levels through a different mechanism of action compared to erythropoiesis-stimulating agents. As a HIF-PH inhibitor, roxadustat activates the body's natural response to reduced oxygen levels in the blood. This response involves the regulation of multiple, coordinated processes that lead to the correction of anemia with a reduced need for intravenous iron. The positive opinion from the CHMP will now be reviewed by the EC, which has the authority to approve medicines for European Union member states, as well as Iceland, Norway, Liechtenstein and Northern Ireland.13 The EC has 67 days from the CHMP opinion to issue a final decision.
AMPE

Hot Stocks

09:17 EDT Ampio announces dosing in AP-019 Phase II clinical trial - Ampio Pharmaceuticals announced randomization and dosing of patients in its multi-center AP-019 Phase II clinical trial, using inhaled Ampion in the treatment of respiratory distress due to COVID-19, is underway. "We saw strong, positive results in our Phase I trial, reducing all-cause mortality in COVID-19 respiratory distress by 78%. If this Phase II study further confirms the efficacy results seen in our Phase I study, I can envision moving forward quickly with an application for Emergency Use Authorization for Ampion in treating patients suffering from respiratory distress due to COVID-19," said Michael Macaluso, President and CEO of Ampio.
DTE DTM

Hot Stocks

09:14 EDT DTE Energy declares 82.5c per share dividend, payable October 15 - The DTE Energy (DTE) Board of Directors on Thursday declared an 82.5c per share dividend on its common stock payable Oct. 15, 2021 to shareholders of record at the close of business Sept. 20, 2021. The company said: "This continues DTE Energy's history issuing a cash dividend for more than 100 years. The October dividend reflects the company's performance as a predominantly pure-play utility company."As previously announced, the Board of Directors authorized management to spin off the midstream company. "The spin generates a combined dividend of DTE and DT Midstream ( DTM) that is expected to be higher than DTE's pre-spin dividend," said Jerry Norcia, DTE Energy president and CEO. DTE Energy expects to continue a payout ratio and dividend growth target consistent with pure-play utility companies. DTM plans to establish a growing dividend with an initial level competitive with midstream peers.
TSLA PCRFY

Hot Stocks

09:14 EDT Panasonic sells Tesla stake for $3.6B - Panasonic (PCRFY) has confirmed it has sold its entire stake in Tesla (TSLA) for about $3.6B, stating that it completed the share sale during its last fiscal year, which ended in March, and notified Tesla of the transactions. The Japanese battery maker said the move wouldn't affect its supply of batteries to Tesla and that the two companies maintain a good relationship. Panasonic was a partner with Tesla on its Nevada "Gigafactory" that caused years of losses at Panasonic before the company said this year it was finally turning a quarterly profit, noted Dow Jones' Yang Jie. A Panasonic spokeswoman told Jie that the company intended to allocate the funds for "growth investments," without giving details.
STON

Hot Stocks

09:10 EDT StoneMor Partners set to join Russell 3000, Russell Microcap Indexes - StoneMor announced that the company will be added to the Russell 3000 and Russell MicroCap Indexes at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the US market opens on June 28, according to a preliminary list of additions posted June 4.
IKNX

Hot Stocks

09:10 EDT Ikonics trading resumes
CMLS

Hot Stocks

09:06 EDT Cumulus Media announces completion of $175M debt paydown - Cumulus Media announced that it has successfully completed its previously announced actions to pay down $175M of debt using cash on hand as further described below.
FSBW

Hot Stocks

09:05 EDT FS Bancorp announces two-for-one stock split, increased quarterly dividend - FS Bancorp announced that its Board of Directors declared a two-for-one stock split in the form of a 100% stock dividend, payable July 14, 2021, to shareholders of record as of July 6, 2021. Under the terms of the stock split, the Company's shareholders will receive a dividend of one share for every share held on the record date. The dividend will be paid in authorized but unissued shares of the Company's common stock. The par value of the Company's stock will not be affected by the split and will remain at $0.01 per share. The Company anticipates that the outstanding shares of stock after the split will be increased from approximately 4.2 million shares to 8.4 million shares. The Company's most recent quarterly cash dividend was $0.27 per share and was paid on May 20, 2021. The Board of Directors approved a one cent $0.01 increase at its June 24, 2021 meeting for shareholders as of July 23, 2021, payable on August 6, 2021. The quarterly dividend post-split is $0.14 per share.
YMAB

Hot Stocks

09:04 EDT Y-mAbs' 177Lu-omburtamab-DTPA receives positive opinion on OMPD by EMA - Y-mAbs Therapeutics announced that the Committee for Orphan Medicinal Products of the European Medicines Agency, or EMA, has recommended the granting of orphan medicinal product designation, OMPD, in the European Union for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma. The positive opinion from the EMA's COMP has been sent to the European Commission, which is expected to grant the orphan drug designation within 30 days. Obtaining OMPD for 177Lu-omburtamab-DTPA is part of an overall plan to expand the Company's European development programs and ultimately obtain orphan drug exclusivity to protect 177Lu-omburtamab-DTPA for the treatment of medulloblastoma in the EU.
USWS

Hot Stocks

09:03 EDT Surge Energy to partner with U.S. Well Services on field trial - Surge Energy US Holdings announces it will partner with U.S. Well Services on a field trial using USWS' all-electric Clean Fleet. This project represents Surge's first well completions using all-electric hydraulic fracturing technology.
FSTR

Hot Stocks

09:03 EDT L.B. Foster CEO Robert Bauer to retire, John Kasel to succeed - L.B. Foster Company announced that Robert Bauer is retiring from the Company after serving as its President and CEO since 2012. The decision is the culmination of a comprehensive CEO succession planning process resulting in the appointment of John Kasel as the Company's next President and CEO, effective July 21, 2021, and his election as a member of the Board of Directors with his term commencing on that same date. Kasel has held senior management positions with L.B. Foster for 18 years, most recently serving as the COO. In order to ensure a seamless transition, Bauer will step down from his role as President and CEO and as a director on July 21, 2021, to serve as a senior advisor to Mr. Kasel through December 31, 2021, at which point he will retire from employment with the Company.
GLBS

Hot Stocks

09:02 EDT Globus Maritime down over 22% at $4.30 after registered direct placement
IEA

Hot Stocks

09:02 EDT Infrastructure and Energy Alternatives appoints new executive vice president - Infrastructure and Energy Alternatives announced the appointment of Erin Roth as Executive Vice President, General Counsel & Corporate Secretary, effective immediately. Roth has over twenty years of legal experience, most recently as the Executive Vice President, General Counsel & Secretary of Strada Education Network. Roth is replacing Gil Melman who has left to pursue other opportunities.
OPRA

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09:02 EDT Opera to integrate first stablecoins in its crypto wallet - Opera and Celo announced that Opera will integrate Celo Native Asset, Celo Dollar, and Celo Euro stablecoins in its Crypto Wallet. This integration enables millions of Opera users to make purchases, send peer-to-peer remittances, trade, or cash in and cash out in Celo's native asset or cUSD stablecoin from the browser's built-in crypto wallet. Opera has also joined the Celo Alliance for Prosperity, a mission-aligned network of 140+ organizations fostering social impact and financial inclusion through the use of blockchain technology.
ALPMY FGEN

Hot Stocks

08:59 EDT Astellas Pharma, FibroGen announce positive CHMP opinion for roxadustat - Astellas Pharma (ALPMY ) and FibroGen (FGEN) announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion relating to the use of roxadustat for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease.
SJI

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08:55 EDT SJI joint venture Catamaran Renewables announces fuel cell project in NY - Catamaran Renewables announced the acquisition of a third fuel cell project in Bronx, New York. The partners acquired the fuel cell from NineDot Energy. The Fuel Cell Project comprises 5.0 MW of installed capacity and is projected to achieve commercial operation in Q4 2021. Similar to the two fuel cells in Staten Island that we brought on-line in 2020, this investment qualifies under New York's Value of Distributed Energy Resources program. With roughly 75% of fuel cell revenues fixed under VDER and an anticipated 95% availability rate, these projects produce steady, low-risk cash flows and unlevered returns in line with our hurdle rate for non-utility investments. Marina will own 92% of the project and accordingly, receive 92% of the ITC, cash flows and net income associated with the project. The project is supported by long-term offtake agreements with two creditworthy anchor customers. This project will support a substantial portion of our 2021 ITC goals.
VIR

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08:53 EDT Vir Biotechnology presents clinical data from trials of VIR-2218, VIR-3434 - Vir Biotechnology announced new data from its ongoing Phase 2 clinical trials of VIR-2218 and ongoing Phase 1 studies of VIR-3434 in patients with chronic hepatitis B virus infection. The results, which demonstrate positive safety findings plus a reduction in hepatitis B surface antigen for both compounds, were presented in two oral and two poster presentations at the European Association for the Study of the Liver International Liver Congress 2021, which is taking place virtually. Vir will hold a conference call and webcast, Friday, June 25, 2021, at 11:00 a.m. ET, to discuss the new data presented at the meeting. In summary, data presented this week demonstrate the promising safety profile and potential durable response of VIR-2218, an investigational small interfering ribonucleic acid that mediates RNA interference, through 48 weeks. In a separate analysis evaluating VIR-2218 in combination with pegylated interferon alfa for 12 weeks, a more rapid and substantial HBsAg decline was observed in the co-administration cohort compared to VIR-2218 alone. The treatment regimen resulted in no new safety signals. Additionally, two new analyses from an ongoing Phase 1 trial of VIR-3434 showed no safety signals in healthy volunteers dosed with up to 3,000 mg, and a rapid reduction in HBsAg levels one week after subcutaneous administration of this investigational HBV-neutralizing monoclonal antibody, which has been Fc engineered to include the XX2 "vaccinal mutation," allowing it to potentially function as a T cell vaccine. VIR-2218: Key Data: Results from a Phase 2 multiple-ascending dose trial of VIR-2218 in 32 patients with chronic HBV infection evaluating the safety and antiviral activity of two doses of VIR-2218 administered subcutaneously four weeks apart demonstrate: Dose-dependent reductions in HBsAg through 48 weeks in both trial participants with hepatitis B e antigen, a marker of actively replicating HBV, and those without. Of the 12 participants who received the 100 mg or 200 mg dose, four participants experienced sustained HBsAg reductions of greater than1 log10 IU/mL and absolute HBsAg levels below 100 IU/mL through Week 48. Treatment with VIR-2218 achieved dose-related reductions in other viral biomarkers; one patient receiving 200 mg experienced HBeAg loss at Week 24 and anti-HBe seroconversion at Week 16 that was sustained through Week 48. Adverse events were mild, and no dose-dependent changes in post-treatment ALT levels occurred. No trial participants discontinued treatment. In a separate ongoing Phase 2 trial, 47 adult patients with chronic HBV infection were assigned to receive subcutaneously injected VIR-2218 alone or in combination with PEG-IFN-alpha. Preliminary results through Week 12 of the treatment period demonstrate: VIR-2218 alone and in combination with PEG-IFN-alpha were associated with HBsAg reductions of greater than1 log10 IU/mL by Week 12. Co-administration of VIR-2218 with PEG-IFN-alpha resulted in a more rapid and substantial HBsAg decline compared to VIR-2218 alone. In Cohort 3, the mean HBsAg decline from baseline was 2.0 log10 IU/mL at Week 12 and 0.6 log10 IU/mL greater than in the two cohorts evaluating VIR-2218 alone. In published studies, PEG-IFN-alpha alone in virally suppressed patients was associated with less than or equal to 0.25 log10 IU/mL HBsAg decline, on average, over the first 12 weeks. No treatment-related grade greater than or equal to3 treatment-emergent adverse events or serious adverse events were reported with VIR-2218 alone or in combination with PEG-IFN-alpha, and the combination did not appear to increase the known side effects of PEG-IFN-alpha. VIR-3434: Key Data: Results from a Phase 1 trial evaluating VIR-3434 in 40 virally suppressed patients with chronic HBV infection who were randomized to receive a single low dose of either 6 mg or 18 mg for four weeks demonstrate: Treatment with VIR-3434 resulted in rapid greater than1 log10 IU/mL reductions in HBsAg, with the largest reductions observed in the 18 mg cohort; maximum reductions were generally observed within one week. No new safety signals were identified with single doses of VIR-3434; all adverse events were grade 1 or 2. No significant changes in liver-related laboratory parameters or clinically significant changes in ALT or other liver-related laboratory parameters were reported. In a separate Phase 1 trial in 40 healthy adult volunteers evaluating single doses of up to 3,000 mg of VIR-3434 administered subcutaneously or intravenously, results demonstrate: Subcutaneous administration of VIR-3434 showed favorable pharmacokinetic properties, with VIR-3434 remaining in the serum for 24 weeks. No new safety signals were identified; specifically, no grade 3/4 adverse events, serious adverse events or adverse events leading to trial discontinuation were reported.
IKNX WULF

Hot Stocks

08:43 EDT IKONICS, TeraWulf announce merger agreement - TeraWulf announced it expects to become a Nasdaq-listed company through a business combination with IKONICS (IKNX). The companies have entered into a definitive merger agreement to combine under a new holding company, which will change its name to TeraWulf Inc. and is expected to be listed on The Nasdaq Stock Market under the trading symbol "WULF". Under the terms of the agreement, which has been unanimously approved by the Boards of Directors of both companies, each outstanding share of IKONICS common stock will receive $5.00 in cash, one CVR, and one share of the combined company's common stock. Through the CVRs, which will not be publicly traded, the IKONICS shareholders will be entitled to received 95% of the net proceeds from any sale of IKONICS's legacy business completed during the 18 months following the closing of the business combination, and will expire at the end of such 18 month period with respect to any portion of IKONICS's legacy business which has not been sold. The shares of the combined company's common stock to be received by the IKONICS shareholders will collectively represent 2% of the combined company's pro forma common equity ownership. As of March 31, 2021, IKONICS had a net book value of $11.6M, cash of $4.4M and working capital of $4.1M. Following consummation of the transaction, the legacy business of IKONICS will be operated consistent with past practices but will be positioned for sale on terms that are acceptable to the Board of Directors of the combined company. The transaction is expected to close in the second half of 2021, subject to the receipt of regulatory approvals, the approval of IKONICS and TeraWulf shareholders, and other customary closing conditions.
F

Hot Stocks

08:39 EDT Ford issues Canadian safety recall for certain 2015- 2020 Ford Transit vehicles - Ford Motor is issuing a safety recall for certain 2015-2020 model year Ford Transit vehicles with short-arm, manual-fold, power-adjust outside rearview mirrors in corrosion provinces that can corrode at the mirror pivot, potentially loosening or breaking the mirror pivot flange. An outside rearview mirror that has become separated from the mirror pivot can limit the field of view of the driver to observe traffic conditions surrounding the vehicle, increasing the risk of a crash. This action affects approximately 37,221 vehicles that were originally sold in - or currently reside in - the Canadian provinces of New Brunswick, Newfoundland and Labrador, Nova Scotia, Ontario, Prince Edward Island, or Quebec. Ford is not aware of any reports of accidents or injuries related to this condition. Dealers will replace outside rearview mirror assemblies on affected vehicles. Customer notifications will begin the week of August 16.
CNI KSU

Hot Stocks

08:35 EDT CN, KCS announces publication of op-ed on rail merger transaction - CN (CNI) and Kansas City Southern (KSU) highlighted the benefits realized by grain customers, including farmer-owned grain co-operatives, through CN's open gateways commitment in the CN-KCS combination. These stakeholders, including agricultural customers in the Upper Midwestern U.S., would benefit from a choice of routes and competitive rates, better service and innovation resulting from the competition for their business. "CN's commitment to keep gateways open on commercially reasonable terms means that agricultural customers, including farmer-owned co-operatives, enjoying competitive joint line routings with CN or KCS, will continue to have those routings available upon completion of the merger," said James Cairns, CN's Senior Vice President, Rail Centric Supply Chain. "This commitment assures grain customers shipping over CP lines to Kansas City and beyond will continue to enjoy the interline service they have today, along with new, enhanced rail-to-rail competition. However, for these benefits to be realized, the CN voting trust must be approved by the Surface Transportation Board". In an op-ed published by Railway Age on June 22nd, Dr. William Huneke, the former Director of the Office of Economics and Chief Economist at STB described CN's open gateways commitment as a "big deal," stating:"This commitment ensures that shippers who today enjoy competitive joint line routings with either CN or KCS will continue to have those routings available to them in a post CN/KCS merger environment, even if a merged CN/KCS could handle the entire movement via a single-line routing." "This means continued competition, and we know that competition encourages lower rates, better service and innovation...The commitment is not just about maintaining physical routings, but also about ensuring that the routings are commercially reasonable to the shipper. What is meant by "open on commercially reasonable terms"? This means all market participants, railroads and shippers will benefit: They will get a fair chance to compete. They will pay and receive remunerative rates and get efficient service. If a shipper is not happy with their service, they can switch to another carrier because they will still have a choice...A CN/KCS combination will create a strong new rail-to-rail competitor that will provide new single-line rail movements in competition with other rail carriers. In addition, with the gateway commitment, shippers will also have the option to use an existing routing or other routings involving more than just the merged CN/KCS."
CSCW

Hot Stocks

08:35 EDT Color Star Technology added to Russell Microcap Index - Color Star Technology announces that it will be added to the Russell Microcap Index at the close of trading on June 25.
PLBY

Hot Stocks

08:33 EDT PLBY Group to join Russell 2000 Index, Russel 3000 Index - PLBY Group announced that PLBY Group is expected to join the small cap Russell 2000 Index and the broad-market Russell 3000 Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the US market opens on June 28, 2021, according to a preliminary list of additions posted by FTSE Russell on June 4, 2021.
VERU

Hot Stocks

08:32 EDT Veru enrolls first patient in phase 3 VERACITY clinical trial of sabizabulin - Veru announced that it has enrolled the first patient in its Phase 3 VERACITY clinical trial of sabizabulin, an oral, new chemical entity, androgen receptor transport disruptor, for metastatic castration and androgen receptor targeting agent resistant prostate cancer. The Phase 3 VERACITY clinical trial is an open label, randomized, multicenter registration study to evaluate the efficacy and safety of sabizabulin 32mg oral daily dosing versus an alternative androgen receptor targeting agent for the treatment of chemotherapy naive men with metastatic castration resistant prostate cancer who have progressed on at least one androgen receptor targeting agent. The primary endpoint is median radiographic progression free survival and key secondary endpoints are overall response rate, duration of objective response, overall survival, time to chemotherapy, and pain progression. The study is expected to enroll 245 patients and will be conducted in over 45 clinical sites across the United States. "We are excited to begin enrolling patients in our open label Phase 3 VERACITY clinical trial," said Mitchell Steiner, MD, Chairman, President and CEO of Veru Inc. "As we have previously reported, in the Phase 1b/2 clinical trial sabizabulin had significant evidence of tumor efficacy including PSA declines and responses as well as objective and durable tumor responses. Furthermore, sabizabulin was well tolerated without neutropenia... If the Phase 3 is successful, sabizabulin could be the next 'go to drug' in the largest and growing unmet medical 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."
ABBV PFE

Hot Stocks

08:32 EDT AbbVie: FDA won't meet PDUFA action dates for sNDAs for RINVOQ - AbbVie (ABBV) announced that the U.S. FDA has informed the company that the FDA will not meet the Prescription Drug User Fee Act action dates for the supplemental New Drug Applications for RINVOQ for the treatment of adults with active psoriatic arthritis and adults with active ankylosing spondylitis. The FDA cited its ongoing review of Pfizer's (PFE) post-marketing study, ORAL Surveillance, evaluating tofacitinib in patients with rheumatoid arthritis. No formal regulatory action has been taken on the sNDAs for RINVOQ in psoriatic arthritis and ankylosing spondylitis. "RINVOQ has demonstrated strong efficacy data, a safety profile that is well characterized from large long-term studies and a favorable benefit-risk profile," said Michael Severino, M.D., vice chairman and president, AbbVie. "We remain committed to working with the FDA to bring RINVOQ to patients living with psoriatic arthritis, ankylosing spondylitis and other immune-mediated diseases."
IKNX

Hot Stocks

08:25 EDT Ikonics trading halted, news pending
VZ RBGLY

Hot Stocks

08:11 EDT Verizon appoints Reckitt Benckiser CEO Laxman Narasimhan to board - Verizon Communications (VZ) announced the election of Laxman Narasimhan, to the Verizon Board of Directors, effective July 1, 2021. Laxman is CEO of Reckitt Benckiser Group (RBGLY), a FTSE 12 listed British multinational consumer health, hygiene and nutrition company. He also serves as a director of Reckitt. The addition of Mr. Narasimhan will bring Verizon's total board membership to ten, nine of whom are independent, effective July 1, 2021.
CNI KSU

Hot Stocks

08:09 EDT CN, KCS publish op-ed on rail merger transaction - An op-ed co-authored by JJ Ruest, President and CEO of CN (CNI) and Patrick Ottensmeyer, President and Chief Executive Officer of Kansas City Southern ("KSU) was published in The Hill yesterday under the headline "Rail merger is a key to economic growth, supply chain security." In the op-ed, Ruest and Ottensmeyer articulated how the combination of CN and KCS will supply critical infrastructure to shorten supply chains. They underscored that the combination will enhance competition and support the economies of the United States, Mexico and Canada, allowing the US-Mexico-Canada Agreement to reach its full potential: "Consider an auto manufacturer in Michigan: Our track would directly connect Detroit to the heart of Mexico, giving U.S. manufacturers more competitive routes and the ability to create U.S. jobs as they meet new domestic and regional content requirements under the USMCA. Other potential beneficiaries include grain farmers in Illinois, Iowa and Wisconsin who would have expanded reach into global markets, as well as ethanol producers in Iowa who would have direct access to markets in Mexico; home-builders in Texas and poultry farmers in Arkansas would benefit from expanded supply networks of lumber and source feed ingredients." Ruest and Ottensmeyer also highlighted key environmental benefits the combination will deliver to customers and communities: "For a single route, from San Luis Potosi, Mexico, to Detroit, Mich., moving freight from trucks to trains would save 260,000 tons of CO2 per year, the equivalent of the average annual emissions of more than 300 long-haul trucks. Multiply that across multiple routes and years, and the impact would be significant." The op-ed also advocated for the approval of CN-KCS' proposed plain vanilla voting trust.
ADIL

Hot Stocks

08:08 EDT Adial Pharmaceuticals' AD04 denied FDA Fast Track Designation - Yesterday evening , the company "announced that it has received correspondence related to its request for Fast Track Designation from the FDA for its drug candidate, AD04, for the treatment of Alcohol Use Disorder in pediatric patients and adult patients with Alcoholic Liver Disease with select polymorphisms of the serotonin transporter and receptor genes. The Company is reporting that its request for Fast Track Designation has been denied at this time. While the FDA did acknowledge the unmet medical needs of adolescents and ALD patients with AUD, the FDA stated in its letter that the Company has not yet demonstrated that the product shows potential to address an unmet medical need in the situation where other treatments are available. Additionally, the FDA stated additional information would be required regarding how AD04 might compare to other therapies if the Company desires further consideration. Based on this feedback, Adial will review the additional requirements and data requested by the FDA for a Fast Track Designation... While AD04 is being developed and undergoing a pivotal Phase 3 trial to treat any adult with AUD with the targeted genetics, Adial believes AD04 holds the potential to effectively and safely treat AUD patients that are adolescents or have ALD."
CRIS

Hot Stocks

08:07 EDT Curis set to join Russell 2000, 3000 and Microcap indexes - Curis announced that it will be added to the Russell 2000, 3000 and Microcap indexes at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens on June 28, according to a preliminary list of additions posted June 4.
AKYA

Hot Stocks

08:06 EDT Akoya Biosciences appoints Scott Mendel to board of directors - Akoya Biosciences announced the appointment of Scott Mendel to its board of directors. Mendel is currently CEO of GenMark Diagnostics.
BTB

Hot Stocks

08:05 EDT Bit Brother Limited announces completion of name and ticker symbol change - The company stated, "Bit Brother Limited is pleased to announce that effective on June 16, its name has changed from Urban Tea to Bit Brother Limited, and its ticker symbol has changed from MYT to BTB, reflecting our vision for the future to conduct business in the cryptocurrency and blockchain industry. We are also pleased to announce that our US subsidiary, Bit Brother New York Inc., has obtained the money services business license from the U.S. Financial Crimes Enforcement Network Department of the Treasury. The MSB license issued by FinCEN allows Bit Brother NY to act as a foreign exchange dealer, money transfer agent and seller of money orders."
BBQ

Hot Stocks

08:04 EDT BBQ Holdings to acquire Village Inn, Bakers Square restaurants - BBQ Holdings is adding two exciting brands to its roster with the acquisition of Village Inn, a family restaurant concept with 21 company-owned restaurants and 114 franchised restaurants, and Bakers Square, a pie and comfort food concept currently with 13 company-owned restaurants. The transaction, which was announced by BBQ Holdings and VIBSQ-the parent company behind Village Inn and Bakers Square-is expected to close by the end of July. "We believe the Village Inn and Bakers Square concepts are a great complement to our growing portfolio of restaurants," said Jeff Crivello, CEO of BBQ Holdings. "Adding them to our family of brands will only strengthen our company as a whole. We can't wait to start working with the wonderful people who have made Village Inn and Bakers Square what they are today, and we're excited to put these two brands on a new and reinvigorated growth path."
LDOS

Hot Stocks

08:03 EDT Leidos awarded $950M prime contract by U.S. Air Force - Leidos announced it has been awarded a prime contract by the U.S. Air Force to provide solutions for a broad spectrum of aviation requirements. Leidos will support the Air Force's Intelligence Surveillance Reconnaissance & Special Operations Forces Directorate, Sensors Division Non-Standard Foreign Military Sales branches. The multi-award, indefinite delivery/indefinite quantity contract has a total estimated value of $950M. The period of performance for the contract is 13 years total with a 10-year ordering period and an additional 3-year performance period. Work will be performed at locations worldwide.
IMAC

Hot Stocks

08:02 EDT IMAC acquires Active Medical Center in Illinois - IMAC announces the company's expansion in the Chicago market with the asset purchase of Active Medical Center's Naperville, Illinois location, effective Monday, June 28. The medical clinic will be rebranded as a Mike Ditka IMAC Regeneration Center, the third such location in the Chicago metro area and the first in the southwestern suburbs of Chicago. The practice was purchased for an undisclosed amount that represents approximately 2.0x 2020 cash flow. Immediate expense synergies are expected to deliver an additional 0.4x cash flow annually. This acquisition price is consistent with the company's targeted capital allocation for such acquisitions. Moreover, the medical focus of Active Medical Center is consistent with the Company's focus of offering non-surgical pain treatment options and sports medicine services.
IMAB

Hot Stocks

08:02 EDT I-MAB announces China NMPA clearance for Phase 1b trial of felzartamab - I-Mab announced that the Center for Drug Evaluation of the China National Medical Products Administration has approved the Investigational New Drug application to initiate a phase 1b trial of felzartamab, a CD38 antibody, in patients with systemic lupus erythematosus. I-Mab is also currently conducting two parallel registrational trials with felzartamab to aim for registration for the treatment of multiple myeloma in Greater China. Felzartamab originally derived from MorphoSys' HuCAL antibody technology and MorphoSys is currently evaluating the safety and efficacy of felzartamab in patients with anti-PLA2R antibody-positive membranous nephropathy.
FWRD

Hot Stocks

08:02 EDT Forward Air appoints Rebecca Garbrick as CFO - Forward Air announced that Rebecca Garbrick has been named CFO and treasurer of the Company, effective July 4. Garbrick joined Forward in November 2020 as VP and controller before assuming the role of chief accounting officer in March.
BDRBF

Hot Stocks

07:49 EDT Bombardier announces one-day extension to cash tender offer - Bombardier announced a one-business day extension with respect to its cash tender offer previously announced on June 3, 2021 to purchase for cash up to $1,000,000,000 aggregate purchase price of three series of its outstanding senior notes due 2022 and 2023 as identified in the Offer to Purchase, subject to the Acceptance Priority Levels and the 2023 Tender Cap, as applicable, and possible proration, as set forth in the Offer to Purchase containing the terms and conditions of the Tender Offer. Capitalized terms used but not defined herein shall have the meanings assigned to such terms in the Offer to Purchase dated June 3, 2021 with respect to the Tender Offer. The Tender Offer and the Offer to Purchase are hereby amended as follows: The expiration date of the Tender Offer shall be extended by one U.S. federal business day to July 1, 2021, due to the fact that on June 17, 2021, the United States declared June 18, 2021 to be a federal holiday in the United States.
SKIN

Hot Stocks

07:48 EDT Beauty Health announces agreements to acquire four global distributors - Yesterday, The Beauty Health Company, parent of The HydraFacial Company, announced the expansion of its global footprint, with the pending or completed acquisitions of four international, third-party distributors for HydraFacial. The total purchase price for the four distributors will be approximately $35M, consisting of approximately $28M in cash and $7M in shares of the company's Class A Common Stock. This represents an average of 20% seller equity rollover across the four transactions. The company will also be required to issue up to 7.5M shares of Class A common stock to the former owners of HydraFacial pursuant to the earnout provision in the merger agreement related to the company's May 2021 business combination. The transactions, which are expected to be immediately accretive to earnings, and have closed or are expected to close in June 2021, "further solidify the company's direct presence in key international markets, including Germany, Australia, France and Mexico," Beauty Health stated. Expected results from the anticipated acquisition of these distributors in the second half of the year were included in the company's previously provided 2021 outlook. Three of the acquisitions remain subject to customary closing conditions.
JAZZ

Hot Stocks

07:46 EDT Jazz Pharmaceuticals announces Orphan Drug Exclusivity for Xywav - Jazz Pharmaceuticals announced that the U.S. FDA has recognized seven years of Orphan Drug Exclusivity for Xywav oral solution for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. Xywav is an oxybate product with a unique composition of cations resulting in 92% less sodium - or approximately 1,000 to 1,500 mg/night - than sodium oxybate at the recommended dosage range of 6 to 9 grams. The seven-year market exclusivity for Xywav began on July 21, 2020, the date of FDA approval.
INCY MOR

Hot Stocks

07:46 EDT Incyte, MorphoSys receive CHMP opinion for tafasitamab combination authorization - Incyte (INCY) and MorphoSys (MOR) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, has issued an opinion recommending the conditional marketing authorization of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL, who are not eligible for autologous stem cell transplantation, or ASCT. The CHMP opinion to recommend the use of tafasitamab is now being reviewed by the European Commission, which has the authority to grant marketing authorization for medicinal products in the European Union. If approved, tafasitamab would be commercialized in the EU under the brand name Minjuvi. Incyte and MorphoSys share global development rights to tafasitamab and Incyte has exclusive commercialization rights to tafasitamab outside the United States. Incyte and MorphoSys co-commercialize tafasitamab under the brand name Monjuvi in the United States.
AYRWF

Hot Stocks

07:39 EDT AYR Wellness launches Big Pete's Cookies - Ayr Wellness announced the launch of Big Pete's cookies in Florida on Saturday, June 26, and the planned opening of Liberty Health Sciences Spring Hill, on Sunday, June 27, the Company's 36th open dispensary in the state. Big Pete's is the first of many edibles brands Ayr will bring to the Florida market following the approval and opening of its industrial kitchen and manufacturing facility earlier this month. Ayr plans to bring many of its successful product lines from other markets to expand offerings available to patients in Florida and to enhance the customer experience.
ATUSF

Hot Stocks

07:37 EDT Churchill enters LOI to acquire Florence Lake property from Altius - Churchill Resources is pleased to announce that it has entered into a binding letter of intent dated June 24, 2021 with Altius Resources to acquire a 100% undivided interest in certain mining claims comprising the Florence Lake Ni-Cu-PGE property in central Labrador near the coastal community of Hopedale and 175 km south of the Voisey's Bay mine. The Florence Lake Property is host to several Raglan-type ultramafic volcanic-hosted massive and disseminated sulphide nickel showings, and was last explored by Falconbridge between 1990-1997 during which time approximately 6,250m of drilling in 45 shallow holes were conducted, with drill core present on the property for relogging and sampling. Highlights of that work included drill testing of the high-grade Baikie Showing where shallow drilling returned: DDH FLK-92-02: 2.19% Ni, 0.22% Cu, 0.16% Co over 11.32 metres from 44.7 to 56m; DDH FLK-92-12: 1.33% Ni, 0.05% Cu over 13.5 metres from 83.0 to 96.5m The Baikie Showing has demonstrated mineralized continuity over 110m of strike length from twelve drillhole intercepts and mapping, and is interpreted as a near vertically plunging subzone of disseminated, semi-massive and massive sulphide mineralization, consistent with the Raglan or Kambalda style of nickel deposits. Other showings along strike have generated +1.0% nickel grab samples or short intersections and need modern exploration work along with Baikie. The Florence Lake Property is in need of modern, helicopter-borne magnetic and time domain EM surveying and Churchill has engaged a leading contractor for this work in September, with compilations of all historical data already well along. Ground follow-up, prospecting and till sampling work will also be initiated this fall. Under the terms of the LOI, the Company shall have the exclusive option for a period of 24 months to acquire an undivided 100% ownership interest in the Florence Lake Property by: issuing such number common shares in the capital of the Company to Altius, or its nominee, upon the execution date of a definitive option agreement which represents 9.9% of the pro forma basic number of Common Shares outstanding following the issuance of such Common Shares to Altius; incurring a minimum of $1,500,000 in exploration expenditures within 12 months following the execution date of the Option Agreement; completing an equity financing on a private placement basis for aggregate gross proceeds of at least $4 million; following the completion of the Private Placement, issuing to Altius 7,000,000 Common Shares or such lesser number of Common Shares such that after such issuance, Altius shall not own more than 19.9% of the Common Shares outstanding following the issuance of such Common Shares to Altius, on a partially diluted basis; and providing Altius with a nomination right to elect one nominee to the board of directors of Churchill until such time that Altius beneficially owns less than 9.9% of the Common Shares; and providing Altius with a pre-emptive right to participate in future equity financings of Churchill to maintain its share ownership percentage interest in Churchill to a maximum of 19.9% of the issued and outstanding Common Shares until such time that Altius beneficially owns less than 9.9% of the Common Shares. Following the date that the option is deemed to have been exercised in accordance with its terms, Churchill will issue and grant to Altius a 1.6% gross sales royalty on any minerals produced from the claims comprising the Florence Lake Property.
EVAX

Hot Stocks

07:34 EDT Evaxion Biotech develops method to enhance AI drug development - Evaxion Biotech announced the acceptance of a new scientific paper by the International Conference on Machine Learning. The paper is entitled "Efficient Generative Modelling of Protein Structure Fragments using a Deep Markov Model." The paper describes BIFROST, a novel predictive system based on deep probabilistic programming that enables the rapid conversion of sequence data into structural information on protein fragments, which we believe may be useful for drug or vaccine design. Deep probabilistic programming is a new development in machine learning that combines the principled treatment of uncertainty provided by Bayesian statistics with the capabilities of deep learning. Compared to existing protein structure prediction approaches, BIFROST appears to be computationally more efficient, only requires sequence information and, importantly, incorporates an assessment of the reliability of its own predictions.
ARWR

Hot Stocks

07:34 EDT Arrowhead presents ARO-DUX4 data, to file for regulatory clearance in Q3 - Arrowhead presented preclinical data on the development of ARO-DUX4, the company's investigational RNA interference, or RNAi, therapeutic being developed as a treatment for patients with facioscapulohumeral muscular dystrophy, or FSHD, at the FSHD Society International Research Congress. Arrowhead intends to file for regulatory clearance in Q3 to begin clinical studies of ARO-DUX4. Preclinical data demonstrated that Arrowhead's Targeted RNAi Molecule muscle delivery platform can achieve functional delivery to various types of skeletal muscle. Using RNAscope to detect RNAi, after a single 3 mg/kg intravenous dose in a mouse, 76-99% of myofibers in gastrocnemius contained TRiM RNAi. In addition, nonhuman primates receiving three doses of 10 mg/kg of a TRiM RNAi targeting myostatin achieved 79% serum myostatin knockdown with a greater than 70% reduction still being observed at week 12. ARO-DUX4 also achieved dose-dependent knockdown of DUX4 and a deep reduction of DUX4 target gene expression in differentiated FSHD patient-derived myotubes. Additionally, ARO-DUX4 was evaluated in a transgenic FSHD-like mouse model, which has muscle-specific expression of human DUX4 and increased expression of DUX4 target genes. These animals develop a FSHD-like muscle phenotype which includes functional loss. In this model, ARO-DUX4 treatment prevented and reversed a tamoxifen-induced increase in DUX4 and DUX4 target gene expression and prevented DUX4-induced body weight loss. Treatment reversed DUX4-induced body weight loss by day 17 allowing a return to baseline body weight by day 22. The treatment also prevented and reversed muscle fibrosis and prevented rotarod performance loss Lastly, ARO-DUX4 reversed rotarod performance loss by day 15.
SSNLF BIIB

Hot Stocks

07:33 EDT Samsung Bioepis, Biogen receive positive CHMP opinion for BYOOVIZ - Samsung Bioepis (SSNLF) and Biogen (BIIB) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for BYOOVIZ, a biosimilar candidate referencing Lucentis, also known as SB11. Ranibizumab is an anti-VEGF for retinal vascular disorders, which are a leading cause of blindness. BYOOVIZ has been recommended for approval for the treatment of neovascular age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular odemea secondary to retinal vein occlusion and visual impairment due to choroidal neovascularization in the European Union. The CHMP's positive opinion will now be referred to the European Commission, which will decide whether to grant a marketing authorization for BYOOVIZ. If a marketing authorization is granted by the EC, BYOOVIZ would be added to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in Europe: BENEPALI, IMRALDI and FLIXABI.
DYN

Hot Stocks

07:33 EDT Dyne Therapeutics presents preclinical data from FSHD study - Dyne Therapeutics is presenting preclinical data from its facioscapulohumeral muscular dystrophy, FSHD, program during the 28th Annual FSHD Society International Research Congress. Data from in vitro studies in an FSHD patient cell line being presented highlight that Dyne's proprietary FORCE platform enabled targeted muscle delivery with its lead FSHD candidate demonstrating potent suppression of DUX4 transcriptome markers. "It is critically important that we continue to advance the science and new therapeutic candidates for FSHD, a highly debilitating, progressive genetic disease with no approved treatments," said Oxana Beskrovnaya, Ph.D., chief scientific officer of Dyne. "We are excited to share these data, which build upon our prior in vitro studies and support our approach to targeting the genetic basis of FSHD. These results demonstrate that our lead FSHD candidate achieved potent suppression of key DUX4 biomarkers, reinforcing the potential of the FORCE platform to enable targeted delivery to muscle tissue. We look forward to advancing our FSHD program toward the clinic as one of the three IND submissions we have planned between the fourth quarter of 2021 and the fourth quarter of 2022." The in vitro proof of concept studies were conducted using an immortalized FSHD patient cell line. Three well-known DUX4 transcriptome markers MBD3L2, TRIM43, and ZSCAN4 were tracked and a significant increase in expression was observed in these markers once cells were differentiated to myotubes. Dyne's lead FSHD candidate was subsequently evaluated in vitro and showed potent suppression of these DUX4 transcriptome markers with IC50 in the low nanomolar range and also demonstrated superior reduction of these same markers compared to naked PMO.
LDI

Hot Stocks

07:31 EDT LoanDepot names Karin Lockovitch as Chief Risk Officer - loanDepot announced that Karin Lockovitch has joined the company as Executive Vice President, Chief Risk Officer. She will be responsible for all aspects of enterprise risk management. Lockovitch has a deep background in building and leading risk disciplines, having previously held the positions of Executive Vice President, Chief Compliance Officer for both Bank of the West/BNP Paribas and Zions Bancorporation, and Chief Compliance Officer for Consumer Banking at SunTrust.
BMRN

Hot Stocks

07:30 EDT BioMarin receives positive CHMP opinion in Europe for vosoritide - BioMarin Pharmaceutical announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for vosoritide, a once daily injection analog of C-type Natriuretic Peptide to treat achondroplasia in children from the age of 2 until growth plates are closed, which occurs after puberty when children reach final adult height. Achondroplasia is the most common form of disproportionate short stature in humans. A final approval decision, typically consistent with the CHMP recommendation, is expected from the European Commission in Q3. Vosoritide is potentially the first medicine to be approved to treat children with achondroplasia in Europe and would be marketed under the brand name VOXZOGO.
AKU

Hot Stocks

07:20 EDT Akumin to acquire Alliance HealthCare Services for $820M - Alliance HealthCare Services announced that it has entered into an agreement to be acquired for $820M by Akumin. The closing of the transaction is expected in Q3, subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. Upon the closing of the transaction, the combined company will offer the radiology and oncology solutions to patients in the U.S., operating in 46 states, with more than 1,000 hospital and health system customers, 154 independent outpatient radiology centers and 34 radiation therapy centers. The combined company expects to have over 4,000 team members serving more than two million radiology and oncology patient visits annually.
KMX

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07:07 EDT CarMax jumps 6% to $127 after Q1 results beat estimates
RGLS

Hot Stocks

07:07 EDT Regulus presents additional data from ADPKD Program - Regulus Therapeutics announced the presentation of additional data from the first cohort of patients in the company's Phase 1b clinical trial of RGLS4326 for the treatment of autosomal dominant polycystic kidney disease, as well as new preclinical data from relevant animal models of the disease. The E-poster presentation, titled "Preclinical Evaluation and Results from the First Cohort of Phase 1b Clinical Trial of RGLS4326 for the Treatment of Patients with Autosomal Dominant Polycystic Kidney Disease," is available to attendees of the PKD Connect Conference 2021, on Friday, June 25, from 2-3 p.m. CDT. The poster presents results from the company's ongoing Phase 1b study evaluating the safety, pharmacokinetics, and effects on pharmacodynamic biomarkers of multiple doses of RGLS4326 in patients with ADPKD. The data demonstrate clinical proof of mechanism by showing target engagement in the kidneys through a statistically significant increase in urinary biomarkers PC1 and PC2, validating miR-17 as a target for ADPKD treatment. Levels of PC1 and PC2 have previously been shown to be inversely correlated with disease severity. RGLS4326 was well-tolerated with no serious adverse events. The poster also describes new data from relevant preclinical models showing treatment with RGLS4326 results in increased gene and polycystin levels in vitro. In addition, improvements in key disease markers including serum creatinine and BUN were demonstrated in the Pkd1 mouse model that harbors Pkd1 mutation equivalent to human ADPKD.
MHLD

Hot Stocks

07:06 EDT Maiden Holdings to rejoinRussell 2000 Index
PIRS

Hot Stocks

07:06 EDT Pieris Pharmaceuticals announces development of PRS-220, $17M grant - Pieris Pharmaceuticals announced the development of PRS-220, an oral inhaled Anticalin protein targeting connective tissue growth factor, or CTGF, also known as CCN2, for the treatment of idiopathic pulmonary fibrosis, or IPF. The company also announced it has been selected to receive a $17M grant from the Bavarian Ministry of Economic Affairs, Regional Development and Energy for the research and development of PRS-220 for post-acute sequelae of SARS-CoV-2 infection, or PASC, pulmonary fibrosis, or PASC-PF, also known as post-COVID-19 syndrome pulmonary fibrosis or "long COVID". Clinical development of the program for both indications is expected to begin next year.
SPCE

Hot Stocks

07:05 EDT Virgin Galactic jumps 12% to $45.18 after FAA approval of full launch license
PLUG

Hot Stocks

07:04 EDT Plug Power issues 2020 corporateESG report - Plug Power released its 2020 Corporate Environmental, Social and Governance report. The ESG report focuses on data available in the year 2020 and details Plug Power's efforts to link environmental and social impacts to its business strategy to lead the global green hydrogen economy. The report's focus includes Plug Power's GenDrive, GenFuel, GenSure and ProGen product lines, and the operation of its Latham, NY, Clifton Park, NY, Rochester, NY, Spokane, WA, Romeoville, Il, Dayton, OH and Montreal, Canada offices. The company conducted a materiality assessment which will guide our focus in the coming years, and will influence our approach to managing ESG expectations internally, as well as with suppliers and partners. Plug Power's dynamic work in 2020 has laid the building blocks to position the company to become an industry leader in the $10T hydrogen economy. Key results from the year include: Green hydrogen generation activity with renewable energy partners to generate a combined 40+ tons per day with room to expand; 76,944 kilowatt hours of electricity generated to power the Clifton Park facility using Plug Power fuel cell systems; 39.1 million hydrogen fills enabled with Plug Power's dispensing infrastructure; $42,000 raised by Plug Power employees to support local charities; 54% increase in employment of Veterans of the U.S. Armed Services from 2019; Executed recycling program with ELEMENT reducing landfill to only 0.13% of product weight.
ROK

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07:02 EDT Rockwell Automation acquires Plex Systems for $2.22B - Francisco Partners announced it has signed a definitive agreement to sell Plex Systems, a cloud-native smart manufacturing software platform, to Rockwell Automation for $2.22B in cash. The company said Plex's software solutions help manufacturers streamline and modernize their global operations by leveraging the power of shop-floor data to drive improved production performance. Plex has over 700 customers across 37 countries and manages more than 8B transactions per day. The transaction is expected to close in Rockwell's Q4, subject to customary closing conditions and completion of regulatory review.
BMY

Hot Stocks

07:00 EDT Bristol-Myers receives positive CHMP opinion for Opdivo - Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Opdivo for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. The European Commission, which has the authority to approve medicines for the European Union, will now review the CHMP recommendation.
KMX

Hot Stocks

06:57 EDT CarMax CEO says 'we delivered exceptional results in the first quarter' - "We delivered exceptional results in the first quarter thanks to excellent execution by our team in a high demand environment," said Bill Nash, president and CEO. "Our strong performance, which included record net revenues and profitability, reflects the strength of our omni-channel experience and diversified business model across retail, wholesale and CAF. I am also pleased to report we completed our acquisition of Edmunds on June 1, 2021, welcoming an extremely talented set of associates into the CarMax family. While Edmunds will continue to operate as an independent business within CarMax, we look forward to extending and enhancing the success of our partnership, including market leading products like our online instant appraisal offering. As I said at our analyst day in May, we are really excited about our future," concluded Nash. With the most customer-centric experience in our industry, a highly profitable operating and financial model, and significant opportunities to grow our existing businesses and expand across the broader used auto ecosystem, we remain confident in our ability to meet our long-term targets of revenue growth, total unit growth and market share gains."
KMX

Hot Stocks

06:56 EDT CarMax reports 452,188 units sold in Q1, up 128% y/y - The company stated, "Sold 452,188 units through our retail and wholesale channels combined, up 128% from the prior year quarter and up 31% over a record first quarter in fiscal year 2020, primarily driven by significant demand for used autos and solid execution supported by our rapidly evolving omni-channel experience. Retail used unit sales increased 100.6% to 270,799 vehicles; comparable store units increased 99.1% compared with a year ago and two-year comparable units grew 16.0%. Wholesale units increased 186.6% to 181,389 from the prior year first quarter and 50.2% versus the first quarter of fiscal year 2020. Bought 341,275 vehicles from consumers in the first quarter, a 236% increase versus the prior year quarter and 77% increase versus the first quarter of fiscal year 2020. We believe CarMax became the largest online buyer of used vehicles from consumers as a result of our nationwide online instant appraisal offerings, with approximately 163,000 vehicles bought in the quarter. Gross profit per retail used unit was $2,205 and wholesale gross profit per unit was $1,025, a $268 and $47 per unit increase, respectively, when compared with the first quarter last year. CarMax Auto Finance income increased to $241.7M due to the combined effects of favorable loan loss performance, higher net interest margin and an increase in average managed receivables."
OSMT

Hot Stocks

06:53 EDT Osmotica Pharmaceuticals to sell legacy business to Alora for up to $170M - Osmotica Pharmaceuticals announced that it has entered into a definitive Purchase and Sale Agreement with Alora Pharmaceuticals, pursuant to which Alora will acquire Osmotica's portfolio of legacy products and its Marietta, Georgia manufacturing facility, for up to $170M. The Boards of Directors of both Osmotica and Alora have approved the transaction, which is expected to close in the third quarter.
BMY

Hot Stocks

06:52 EDT Bristol-Myers receives positive CHMP opinion for Abecma - Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended granting Conditional Marketing Authorization for Abecma, the company's B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The CHMP adopted a positive opinion based on results from the pivotal Phase 2 KarMMa study evaluating the efficacy and safety of Abecma in 128 patients with heavily pre-treated and highly refractory multiple myeloma.
SPCE

Hot Stocks

06:49 EDT Virgin Galactic receives FAA approval for full commercial launch license - Virgin Galactic announced that the Federal Aviation Administration updated the company's existing commercial space transportation operator license to allow the spaceline to fly customers to space. The company also announced that it has completed an extensive review of data gathered from its May 22 test flight and confirmed that the flight performed well against all flight objectives. The adjustment to Virgin Galactic's operator's license, which the company has held since 2016, marks the first time the FAA has licensed a spaceline to fly customers. It is further validation of the company's methodical testing program, which has met the verification and validation criteria required by the FAA. With the data analysis from the May flight now complete, Virgin Galactic will continue preparing for the remaining three test flights.
ADN

Hot Stocks

06:48 EDT Advent Technologies to acquire fuel cell systems businesses of fischer Group - Advent Technologies announced that it has entered into a definitive agreement to acquire the fuel cell systems businesses of fischer Group for an aggregate consideration of cash and stock of EUR52M. These businesses include Serenergy A/S, based in Aalborg, Denmark, and fischer eco solutions GmbH, based in Achern, Germany. The transaction consideration is EUR15M in cash and EUR37M in ADN shares based on Advent's closing share price for the 20 trading days prior to closing, subject to certain closing adjustments. The closing of the acquisition of the SerEnergy and FES businesses is subject to the satisfaction of customary closing conditions for regulatory approval. The transaction is expected to close in the third quarter.
ETN

Hot Stocks

06:46 EDT Eaton acquires 50% stake in Jiangsu YiNeng Electric's busway business - Eaton announced it has completed the acquisition of a 50% stake in Jiangsu YiNeng Electric's busway business, which manufactures and markets busway products in China and had sales of $60M in 2020. Jiangsu YiNeng Electric is a Chinese electrical equipment manufacturer. Founded in 2002 and headquartered in Jiangsu, China, the company serves the data center, infrastructure, commercial building, telecommunications, and industrial segments.
APOG

Hot Stocks

06:35 EDT Apogee Enterprises CEO says Q1 a 'solid start to our fiscal year' - "This was a solid start to our fiscal year, putting us on track to achieve our full year goals," said Ty R. Silberhorn, CEO. "The business recovered strongly from the pandemic-related issues that impacted last year's first quarter. We achieved sales growth in all of our segments, with significantly improved earnings." Silberhorn continued, "During the quarter, we also made good progress on our key initiatives. We continued to take steps to improve our cost structure and strengthen operational execution across the business. We launched several foundational projects to enable our enterprise transformation, and we made substantial progress on our enterprise strategy project, to better position the company for long-term profitable growth."
ROK

Hot Stocks

06:34 EDT Rockwell Automation to acquire Plex Systems for $2.2B in cash - Rockwell Automation and Plex Systems announced that Rockwell has entered into an agreement to acquire Plex for $2.22B in cash. Plex offers the only single-instance, multi-tenant SaaS manufacturing platform operating at scale, including advanced manufacturing execution systems, quality, and supply chain management capabilities. It has over 700 customers and manages more than 8B transactions per day. Plex's software capabilities will be further differentiated by Rockwell's global market access, complementary industry expertise, and ability to turn real-time data into actionable insights. Plex will be reported as part of Rockwell's Software and Control operating segment which provides leading hardware and software offerings for the design, operation, and maintenance of production automation and management systems. As a part of the acquisition, Rockwell will welcome more than 500 highly engaged new employees. The acquisition will be financed with a combination of cash and short-term and long-term debt. Subject to customary closing conditions and completion of regulatory review, the acquisition is expected to close in Rockwell's fiscal fourth quarter.
WD

Hot Stocks

06:32 EDT Walker & Dunlop acquires TapCap, terms undisclosed - Walker & Dunlop announced that it acquired TapCap, a technology firm with proprietary web-based software that provides real-time, online quotes for commercial real estate debt to streamline the loan application and origination process. TapCap's technology is designed to remove friction from the borrower experience. Zac Rosenberg, founder and CEO of TapCap, will join Walker & Dunlop as a leader in their technology group.
ROK

Hot Stocks

06:32 EDT Rockwell Automation to acquire Plex Systems for $2.2B in cash
AMZN...

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06:18 EDT Amazon, Google face formal fake review inquiry in Britain - The U.K.'s CMA has opened a formal probe into Amazon (AMZN) and Google (GOOGL) over concerns that they have not been doing enough to combat fake reviews on their sites. In this next phase of the work, the Competititon and Markets Authority will gather further information to determine whether these two firms may have broken consumer law by taking insufficient action to protect shoppers from fake reviews. The move comes after an initial CMA investigation, which opened in May 2020, and assessed several platforms' internal systems and processes for identifying and dealing with fake reviews. Andrea Coscelli, the CMA's CEO, said: "We are investigating concerns that Amazon and Google have not been doing enough to prevent or remove fake reviews to protect customers and honest businesses. It's important that these tech platforms take responsibility and we stand ready to take action if we find that they are not doing enough." Reference Link
TOSYY

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06:11 EDT Toshiba shareholders oust chairman Osamu Nagayama - Toshiba's chairman, Osamu Nagayama, was ousted in a vote at the company's annual meeting, the company said in a statement. Shareholders also voted against another incumbent director, Nobuyuki Kobayashi, who served on the audit committee. They elected nine directors nominated by the company, and CEO Satoshi Tsunakawa was also re-elected to the board. Reference Link
AMZN

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06:08 EDT Amazon acquires Art19, terms not disclosed - Amazon is acquiring Art19, a podcast hosting and monetization platform, for an undisclosed amount. On its website, Art19 said: "Art19 is joining Amazon Music... Together, we will be able to expand our offerings and even better serve your podcasting needs." Reference Linkvg[p]22313432[t]w[r]feedly.com[d]D]
HITI

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06:05 EDT High Tide to acquire Daily High Club for $10M - High Tide is pleased to announce that it is taking another step towards solidifying itself as the leader within the U.S. e-commerce marketplace for consumption accessories by entering into a definitive agreement pursuant to which High Tide USA Inc., a wholly-owned U.S. subsidiary of the company, will acquire 100% of the issued and outstanding shares of DHC Supply operating as Daily High Club. The Transaction, which is an arm's length transaction, is subject to, among other things, receipt of required TSX Venture Exchange approval, and other customary conditions of closing, is expected to close around the end of June. Pursuant to the terms of the Transaction, High Tide USA , a Nevada corporation and a wholly-owned subsidiary of High Tide, will acquire 100% of the issued and outstanding shares of Daily High Club. Total consideration to Daily High Club shareholders will be $10M and Daily High Club is expected to have approximately $0.8M of cash on closing. The consideration will be comprised of: (i) $6.75M in common shares of High Tide on the basis of a deemed price per High Tide Share equal to the volume weighted average price per High Tide Share on Nasdaq for the 10 consecutive trading days preceding the closing of the Transaction; and (ii) $3.25M in cash. In connection with the Transaction, High Tide is excited to announce that Harrison Baum will be joining the High Tide team on Closing as Director of Digital Marketing to oversee all social media initiatives for High Tide globally. The Transaction has been unanimously approved by the board of directors/managers of each of High Tide and Daily High Club. The High Tide Shares issued pursuant to the Share Consideration are subject to a statutory hold period of four months and one day. In addition, shares having a value of 25% will be held in escrow to insure certain indemnification obligations if claims arise.
HITI

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06:04 EDT High Tide to acquire Daily High Club for $10M in shares and cash - High Tide announced that it is entering into a definitive agreement pursuant to which High Tide USA, a wholly-owned U.S. subsidiary of the company, will acquire 100% of the issued and outstanding shares of DHC Supply operating as Daily High Club. The transaction, which is an arm's length transaction, is subject to, among other things, receipt of required TSX Venture Exchange, or TSXV, approval, and other customary conditions of closing, is expected to close around the end of June. Pursuant to the terms of the transaction, High Tide USA will acquire 100% of the issued and outstanding shares of Daily High Club. Total consideration to Daily High Club shareholders will be $10M and Daily High Club is expected to have approximately $0.8M of cash on closing. The consideration will be comprised of: $6.75M in common shares of High Tide on the basis of a deemed price per High Tide Share equal to the volume weighted average price per High Tide Share on Nasdaq for the 10 consecutive trading days preceding the closing of the transaction and $3.25M in cash. In connection with the transaction, High Tide is excited to announce that Harrison Baum will be joining the High Tide team on closing as director of digital marketing to oversee all social media initiatives for High Tide globally. The Transaction has been unanimously approved by the board of directors/managers of each of High Tide and Daily High Club. The High Tide Shares issued pursuant to the Share Consideration are subject to a statutory hold period of four months and one day. In addition, shares having a value of 25% will be held in escrow to insure certain indemnification obligations if claims arise.
JKS

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05:29 EDT JinkoSolar sees FY21 total shipments 25 GW-30 GW - The company said, "The Company's business outlook is based on management's current views and estimates with respect to market conditions, production capacity, the Company's order book and the global economic environment. This outlook is subject to uncertainty on final customer demand and sale schedules. Management's views and estimates are subject to change without notice."
AUPH

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05:23 EDT Aurinia Pharmaceuticals announces OPEL files voclosporin MAA to EMA - Aurinia Pharmaceuticals announced that the company's licensing partner, Otsuka Pharmaceutical, or OPEL, filed an initial marketing authorization application, or MAA, for voclosporin for the treatment of lupus nephritis, or LN, to the European Medicines Agency, or EMA. LN is a complication of the autoimmune disease systemic lupus erythematosus, or SLE, that impacts the kidneys. Once the MAA is approved, OPEL would be authorized to market voclosporin in the European Union, Norway, Iceland, and Liechtenstein. As part of the agreement, Aurinia received a $50M U.S. upfront cash payment with the potential to secure up to $50M in additional regulatory and reimbursement milestone payments. In addition, Aurinia will receive tiered royalties ranging from 10% to 20%, dependent on net and annual sales following commercialization, along with additional milestone payments based on the attainment of certain annual sales by OPEL. Voclosporin will be provided to OPEL under a cost-plus supply agreement.
CEO

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05:19 EDT Cnooc commences production on Lingshui 17-2 gas field - Cnooc announced that the China's first offshore large-sized independent deepwater gas field, Lingshui 17-2 gas field has commenced production. The Lingshui 17-2 gas field is located in the northern sea of Qiongdongnan Basin, with water depth of approximately 1,560 meters. It was the first large-sized deepwater discovery, with proven geological resources of natural gas exceeding 100B cubic meters, made by independent exploration, proving the potential of deepwater area of South China Sea. A new semi-submersible production platform has been built, with condensate oil storage capacity, a mooring system, as well as a set of underwater production system and subsea pipeline. A total of 11 production wells are planned. It is expected to reach peak production of 328M cubic feet of natural gas and 6,751 barrels of condensate per day in 2022, with a 10-year stable production period. After the commencement of production, natural gas will be connected to the national gas pipeline network through submarine pipelines, and will become one of the sources of stable natural gas supply for Guangdong-Hong Kong-Hainan area. Cnooc holds 100% interest of Lingshui 17-2 gas field and acts as the operator.
REGN SNY

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05:17 EDT Regeneron, Sanofi receive European Commission approval for Libtayo - Regeneron (REGN) and Sanofi (SNY) announced that the European Commission, or EC, has approved the PD-1 inhibitor Libtayo to treat adults with locally advanced or metastatic basal cell carcinoma, or BCC, who have progressed on or are intolerant to a hedgehog pathway inhibitor, or HHI.
ABBV

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05:15 EDT AbbVie receives CHMP recommendation for Rinvoq approval - AbbVie announced the European Medicines Agency's, or EMA, Committee for Medicinal Products for Human Use, or CHMP, adopted an opinion recommending the approval of Rinvoq, an oral, selective and reversible JAK inhibitor, for the expanded use in adults and adolescents 12 years and older with moderate to severe atopic dermatitis who are candidates for systemic therapy. Rinvoq is being studied in several immune-mediated inflammatory diseases. If approved, this will be the fourth indication for Rinvoq, and Rinvoqwill be the first JAK inhibitor in the European Union to treat moderate to severe atopic dermatitis in both adults and adolescents 12 years and older.
KW

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05:13 EDT Kennedy Wilson acquires The Capitol Building in England for $66.2M - Kennedy Wilson and its equity partner have acquired The Capitol Building, a 173,000 square-foot institutional quality office campus for $66.2M, reflecting a cap rate of 7.7%. The partnership invested $29M of equity and Kennedy Wilson's ownership interest is 51%. The Capitol Building, in Bracknell, is part of the active Thames Valley submarket.
TIGR

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05:10 EDT TBSPL gets approval-in-principle for Singapore securities trading - UP Fintech announced that its Singapore subsidiary, Tiger Brokers, or TBSPL, has received approval-in-principle to be admitted as a Clearing Member of The Central Depository, or CDP. TBSPL also received approval-in-principle from Singapore Exchange Securities Trading, or SGX, as well as Singapore Exchange Derivatives Trading for admission as a trading member. The company expects to use these approvals-in-principle to improve the user experience and services it offers to clients. TBSPL looks forward to developing its partnerships with CDP and SGX and strengthening its presence in the Singapore market.
RNLSY STM

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05:06 EDT Renault, STMicroelectronics enter cooperation on power electronics systems - Renault (RNLSY) and STMicroelectronics (STM) announced a strategic cooperation on the design, development, manufacturing, and supply to Renault Group of STMicroelectronics' products and related packaging solutions for the power electronics systems of battery-operated and hybrid vehicles. These technologies will have impacts on electric vehicles' driving range and charging by reducing power losses and improving efficiency, which will result in lower battery costs, more kilometers per charge, shorter charging time and reduced user-cost. Renault and STMicroelectronics will work together with the objective of improving the power performance of Renault's Group's applications for electric and hybrid vehicles, based on STMicroelectronics' wide bandgap semiconductor technologies and products. The companies will collaborate on the development of efficient, rightsized, and modular components based on the understanding of Renault Group's technology needs for Silicon Carbide, or SiC, devices, Gallium Nitride (GaN) transistors, along with related packages and modules. As Renault's innovation partner, STMicroelectronics will benefit from significant volumes guaranteed for the annual usage of these power modules and transistors from 2026-2030.