Stockwinners Market Radar for June 29, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
BE | Hot Stocks20:19 EDT Bloom Energy enters joint ship development deal with Samsung Heavy - Bloom Energy and Samsung Heavy Industries have signed a joint development agreement to design and develop fuel cell-powered ships. SHI and Bloom Energy are "working towards the next milestone in this development with a target to present the design to potential customers in 2022. Following commercialization, the two companies anticipate that the market for Bloom Energy Servers on SHI ships could grow to 300 megawatts annually."
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USB | Hot Stocks19:46 EDT U.S. Bancorp announces CCAR SCB of 2.5% through Q3 of 2021 - U.S. Bancorp commented on the results of the Federal Reserve's 2020 Dodd-Frank Act stress tests and related Comprehensive Capital Analysis and Review, or CCAR. Based on its 2020 CCAR results, the company will be subject to a preliminary stress capital buffer, or SCB, of 2.5% for the period beginning October 1, 2020 and ending on September 30, 2021. The SCB, when added to the Basel III Common Equity Tier 1 minimum of 4.5%, requires the company to remain above 7.0% through this period. The Company's CET1 ratio was 9.0% at March 31, 2020 under the CECL transition rules. U.S. Bancorp expects to recommend to its Board that the company continue to maintain its current quarterly common dividend of 42c per common share.
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DFS | Hot Stocks18:34 EDT Discover announces CCAR SCB of 3.5% through Q3 of 2021 - Discover announced that the company has received the results of the Federal Reserve's 2020 supervisory stress testing and capital plan review exercise. Discover's preliminary stress capital buffer, or SCB, has been set at 3.5%. The final SCB for Discover and other firms subject to the Federal Reserve's capital plan rule is expected to be finalized in August and will take effect on October 1, 2020. With regard to capital actions, the company plans to continue its 44c per share common stock dividend in the third quarter. The company suspended its share repurchase program in March 2020 in recognition of the economic environment at that time and will not repurchase shares during the third quarter of 2020.
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FRD | Hot Stocks18:32 EDT Friedman Industries announces 1.06M share stock repurchase - Friedman Industries announced a share repurchase program authorized by the board on June 25, 2020 under which the company may repurchase up to 1,062,067 shares of the company's outstanding common stock through June 30, 2023, which equates to 15% of the company's outstanding shares of common stock as of June 29, 2020.
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BPMC | Hot Stocks18:31 EDT Blueprint Medicines announces AYVAKIT data published in Lancet Oncology - Blueprint Medicines announced that The Lancet Oncology published data from the NAVIGATOR clinical trial showing an unprecedented overall survival rate and a well-tolerated safety profile for AYVAKIT in patients with advanced PDGFRA D842V mutant gastrointestinal stromal tumor. The paper, titled "Avapritinib in advanced PDGFRA D842V-mutant gastrointestinal stromal tumour: a multicentre, open-label, phase 1 trial," was published online in The Lancet Oncology on June 29, 2020. "The data published in The Lancet Oncology show that patients with PDGFRA D842V mutant GIST treated with AYVAKIT had deep and durable clinical responses as well as a high overall survival rate. These results represent a transformative advancement for patients whose tumor type is resistant to other approved therapies," said Michael Heinrich, M.D., Professor of Medicine at Oregon Health & Science University and primary author of the paper. "As a scientist who has dedicated my career to understanding the molecular basis of GIST and as a clinician treating patients, it's tremendously rewarding to be able to offer - for the first time - a highly effective treatment option to my patients with PDGFRA D842V mutant GIST."
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BK | Hot Stocks18:05 EDT BNY Mellon announces Stress Capital Buffer of 2.5% effective October 1st - BNY Mellon announced that the Federal Reserve has notified the company that its Stress Capital Buffer, or SCB, requirement will be 2.5%, equal to the regulatory minimum, effective as of October 1, 2020. Additionally, on June 25, 2020, the Federal Reserve released the results of the 2020 Dodd-Frank Act Stress Test, which demonstrate the "resiliency and strength of BNY Mellon's business model and capital position." The company states that it "intends to maintain its quarterly cash dividend on common stock of 31c per share and will not conduct open market common stock repurchases during the third quarter of 2020 and will resume common share repurchase program as early as possible."
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SNMP | Hot Stocks18:01 EDT NYSE American approves Sanchez Midstream Partners' plan to regain compliance - Sanchez Midstream Partners LP announced that on June 25, 2020, the NYSE American LLC notified the Partnership that it has accepted the Partnership's plan to regain compliance with the Exchange's continued listing standards. As previously disclosed, on April 3, 2020, the Partnership received a letter from the Exchange stating that the Partnership was below compliance with Section 1003(a)(i) of the Exchange's continued listing standards, specifically because the Partnership reported partners' capital of less than $2,000,000 as of December 31, 2019 and had net losses in two of its three most recent fiscal years. The Partnership submitted a compliance plan to the Exchange on May 4, 2020 advising the Exchange how the Partnership plans to regain compliance with the Exchange's continued listing standards by October 3, 2021. The Exchange has reviewed and accepted the plan and the Partnership has been granted a targeted completion date of October 3, 2021 to implement its plan and regain compliance.
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CFG | Hot Stocks18:00 EDT Citizens Financial announces CCAR SCB of 3.4% through Q3 of 2021 - The company states: "Citizens Financial Group announces key aspects of its 2020 Capital Plan, which includes maintaining quarterly common dividends at the current level of 39c per share through the stress capital buffer, or SCB, window period ending third quarter 2021. The company previously announced its intention to cease stock repurchases through December 31, 2020. The company will assess potential changes to its capital distributions over the planning horizon as conditions warrant. The company's announcement follows the publication by the Board of Governors of the Federal Reserve System of the results from its DFAST stress tests and the related Comprehensive Capital Analysis and Review on June 25, 2020 and communication to Citizens of its preliminary SCB of 3.4%. Citizens has concluded that its proposed capital distributions under the Plan would be consistent with effective capital distribution limitations assuming the 3.4% SCB requirement provided by the Federal Reserve were in place during the relevant quarters."
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ARYA | Hot Stocks17:38 EDT Arya Sciences shareholders approve combination with Immatics - Arya Sciences Acquisition Corp. and Immatics Biotechnologies GmbH announced that its respective shareholders approved the business combination between Arya and Immatics announced on March 17. None of Arya's shareholders redeemed their shares in connection with the shareholder approval. The respective boards of directors of both Arya and Immatics had previously approved the business combination. Following the Arya shareholder vote, Immatics and Arya commenced final procedures towards the closing of the business combination and expect the closing to be completed in the coming days. It is further expected that the trading of the shares of the combined company, called Immatics N.V., will commence under the symbol "IMTX" on the first trading day thereafter. Immatics will continue to operate under its existing management team led by CEO Harpreet Singh.
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CVIA | Hot Stocks17:21 EDT Covia Holdings trading halted, news pending
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JPM | Hot Stocks17:18 EDT JPMorgan says SCB requirement will be 3.3% through Q3 of 2021 - JPMorgan announced that it has completed the 2020 Comprehensive Capital Analysis and Review, or CCAR, stress test process. The Firm's indicative Stress Capital Buffer, or SCB, requirement is 3.3% and the Federal Reserve Board will provide the Firm with its final SCB requirement by August 31, 2020. The SCB requirement will become effective on October 1, 2020 and will remain in effect until September 30, 2021. The SCB will be integrated into the Firm's ongoing risk-based capital requirements, increasing the Firm's Basel III Standardized approach minimum Common Equity Tier 1 capital ratio to 11.3%, up from 10.5%.
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LMT | Hot Stocks17:15 EDT Lockheed Martin awarded $360.8M Navy contract modification - Lockheed Martin was awarded a $360.8M not-to-exceed undefinitized contract modification to previously awarded fixed-price-incentive-firm-target contract. This modification provides for the procurement of four F-35C Carrier Variant Lot 14 aircraft for the Navy. Work is expected to be completed by May 2023. FY20 aircraft procurement funds for $170M 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.
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HII | Hot Stocks17:12 EDT Huntington Ingalls awarded $936.03M Navy contract modification - Huntington Ingalls was awarded a $936.03M fixed-price-incentive-firm-target modification to a previously awarded contract to exercise the FY20 option for the construction of a USS Arleigh Burke DDG-51 class ship. This modification also includes options for engineering change proposals, design budgeting requirements and post-delivery availabilities on the FY20 option ship. If exercised, the cumulative value of the fiscal 2020 option ship will increase to $947.7M. Work is expected to be completed by June 2027. FY19 and FY20 shipbuilding and conversion funding in the amount of $926.03M will be obligated at the time of award and will not expire at the end of the current fiscal year. The Naval Sea Systems Command is the contracting activity.
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WFC | Hot Stocks17:11 EDT Wells Fargo sees Q2 results including increase in allowance for credit losses - "There remains great uncertainty in the path of the economic recovery and though it's difficult to accurately predict the ultimate impact on our credit portfolio, our economic assumptions have changed significantly since last quarter. Accordingly, we expect our second quarter results will include an increase in the allowance for credit losses substantially higher than the increase in the first quarter," said CEO Charlie Scharf. "Wells Fargo continues to have one of the strongest capital positions relative to regulatory minimums among the world's financial services firms as demonstrated by our stress test results. These are certainly extremely challenging times for many and we remain committed to supporting our customers and communities, and we will continue to take appropriate measures to maintain strong capital and liquidity levels and to improve the earnings capacity of the company."
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ALTM | Hot Stocks17:04 EDT Altus Midstream to affect 1-for-20 reverse stock split - Altus Midstream announced that effective on June 30, the company will affect a 1-for-20 reverse stock split of its outstanding common stock. The Altus board authorized the reverse stock split, following shareholder approval of the action at the company's annual meeting on May 21. Upon the effectiveness of the reverse stock split, each of the company's shareholders will receive one new share of Altus common stock for every 20 shares of Altus common stock held prior to that date, with no changes in par value per share. Altus will pay cash in lieu of any fractional shares to which a shareholder would otherwise be entitled as a result of the reverse stock split. The company's Class A common stock will begin trading on a split-adjusted basis on the Nasdaq Global Market at the market open on July 1. The reverse stock split is primarily intended to bring the company into compliance with the minimum bid price requirement for maintaining its listing on Nasdaq. Once effective, the number of outstanding shares of common stock will be reduced from approximately 324,929,305 to approximately 16,246,465 shares, including 3,746,465 shares of Class A common stock and 12,500,000 shares of Class C common stock.
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MU | Hot Stocks16:53 EDT Micron up 5.8% at $52/share after Q3 beat, data center outlook commentary
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VRCA | Hot Stocks16:51 EDT Verrica Pharmaceuticals drops over 11% after getting FDA letter on VP-102 NDA - Shares are down over 11% in post-market trading to $12.50 after the company announced that, on June 24 the company received a letter from the U.S. Food and Drug Administration as part of the FDA's ongoing review of the company's New Drug Application for VP-102, Verrica's lead product candidate for the treatment of molluscum contagiosum. The letter states that there are deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
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PTON LULU | Hot Stocks16:46 EDT Lululemon up over 3% after announcing $500M acquisition of MIRROR - Share of Lululemon (LULU) are up 3.5% at $304.54 after announcing a $500M deal for in-home fitness company MIRROR. Shares of Peloton (PTON) are also trading down over 2% after the announcement.
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STT | Hot Stocks16:45 EDT State Street suspends share repurchases for Q3
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ETFC MS | Hot Stocks16:43 EDT Morgan Stanley CEO says E-Trade will diversify, anticipates maintaining dividend - James P. Gorman, Chairman and Chief Executive Officer of Morgan Stanley (MS), said, "The CCAR 2020 results affirm our strong capital position and reflect the stability of our business model. Our E*TRADE (ETFC) transaction will further diversify our business model and add to our excess capital and liquidity positions. We anticipate continuing to pay our quarterly common stock dividend of 35c per share. We voluntarily suspended our share repurchases in March and have continued to accrete capital. The updated capital rules provide us flexibility to deploy our excess capital, and we will reevaluate our capital actions when we have more confidence in the shape and path of the economic recovery. We will continue to invest in our businesses and support our clients, evidenced by the approximately $100 billion of incremental balance sheet that we have deployed since January 1, 2019."
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AGEEF | Hot Stocks16:41 EDT Halo Labs announces extension of LOI with Canmart - Halo Labs announced that the company has agreed to another extension of the binding letter of intent, or LOI, to acquire all of the common shares of Canmart, a licensed importer and distributor of cannabis based products for medicinal use. Due to the ongoing global COVID-19 pandemic, the company has agreed to the extension to allow both parties adequate time to complete due diligence and negotiate the definitive agreements while under shelter-in-place restrictions. While the extension grants until August 21 to finalize, the company anticipates signing the final SPA and closing the transaction on or about July 15. The total purchase price of the Canmart acquisition is anticipated to be C$6M, payable in Halo common shares and at a deemed price of C$0.35 per share, which is based on the 30-day VWAP of the Halo Shares on the NEO Exchange as of December 23, 2019, the day the LOI was originally executed. The consideration will be paid periodically as Canmart achieves critical business milestones.
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BNED | Hot Stocks16:40 EDT Barnes & Noble Education confirms Outerbridge nominates four director candidates - Barnes & Noble Education confirmed that it has received correspondence from Outerbridge Capital regarding its intent to nominate four director candidates to stand for election at BNED's 2020 Annual Meeting of Stockholders. The Corporate Governance and Nominating Committee and the BNED board will carefully review and consider Outerbridge's director candidates, as well as the validity of the purported nomination notice delivered by Outerbridge. A formal recommendation regarding director nominees will be included in the company's proxy statement and other materials.
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MS | Hot Stocks16:40 EDT Fed tells Morgan Stanley it will be subject to Stress Capital Buffer of 5.9% - On June 25, the Board of Governors of the Federal Reserve System released its CCAR 2020 results and notified Morgan Stanley that it will be subject to a Stress Capital Buffer, SCB, of 5.9% from October 1 to September 30 . Together with other features of the regulatory capital framework, this SCB results in an aggregate U.S. Basel III Standardized Approach Common Equity Tier ,CET1, ratio of 13.4%. The Firm's U.S. Basel III Standardized Approach CET1 ratio was 15.7% as of March 31. James P. Gorman, Chairman and Chief Executive Officer of Morgan Stanley, said, "The CCAR 2020 results affirm our strong capital position and reflect the stability of our business model. Our E*TRADE transaction will further diversify our business model and add to our excess capital and liquidity positions. We anticipate continuing to pay our quarterly common stock dividend of 35c per share. We voluntarily suspended our share repurchases in March and have continued to accrete capital. The updated capital rules provide us flexibility to deploy our excess capital, and we will reevaluate our capital actions when we have more confidence in the shape and path of the economic recovery. We will continue to invest in our businesses and support our clients, evidenced by the approximately $100 billion of incremental balance sheet that we have deployed since January 1, 2019." The Firm remains focused on closing the acquisition of E*TRADE Financial Corporation in the fourth quarter of 2020, subject to customary closing conditions, which will continue its business transformation towards more durable sources of revenue and strengthen and increase its capital and liquidity positions.
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HEPA | Hot Stocks16:40 EDT Hepion Pharmaceuticals advances final dose level in clinical trial of CRV431 - Hepion Pharmaceuticals announced the advancement to the final dose level in its ongoing clinical trial of CRV431, a Phase 1b multiple ascending dose, or MAD, study. The company states its "open-label MAD study is designed to assess safety, tolerability and pharmacokinetics of CRV431, administered orally to healthy volunteers, once daily for 28 days. To date, the study has examined doses of 75 mg, 150 mg, 225 mg and 300 mg. The Clinical Trial Management team has reviewed the 300 mg cohort data and determined this dosing level to be safe and well tolerated, authorizing advancement to the final dosing level of 375 mg daily for 28 days." Dr. Patrick Mayo, Hepion's Senior Vice-President, Clinical Pharmacolony, says: "However, we have not yet observed any dose-limiting side effects, even at 300 mg. As such, we decided to add one final dosing cohort of 375 mg to fully evaluate safety and tolerability, and pharmacokinetics of CRV431. This study has demonstrated that steady-state CRV431 concentrations achieved at a 75 mg daily dose are in the range that demonstrates efficacy in animal models and human liver tissue. This suggests that the dosing range captured in this study effectively explored clinically relevant exposures."
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STT | Hot Stocks16:39 EDT State Street to continue 52c per share quarterly dividend
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STT | Hot Stocks16:39 EDT State Street sees SCB requirement of 2.5% starting in 4Q20 - State Street announced its preliminary inaugural stress capital buffer (SCB) requirement of 2.5% beginning in the fourth quarter of 2020 and the intention to continue its quarterly common stock dividend of $0.52 per share in the third quarter subject to consideration and approval by its Board of Directors. State Street's calculated SCB under this year's supervisory stress test was well below the 2.5% minimum, preliminarily resulting in an SCB at that floor. The firm's capital position remains strong amid the considerable economic uncertainty created by the COVID-19 pandemic. Accordingly, the Company will consider a full range of capital actions, including the potential resumption of share repurchases, in upcoming quarters but will do so commensurate with economic conditions at the time, the importance of safety and soundness, the review of the supplemental CCAR scenarios to be established by the Federal Reserve, and subject to any interim regulatory limitations. The Company is suspending share repurchases for the third quarter of 2020, consistent with the Federal Reserve's instructions to all large banks. "We are pleased with our 2020 CCAR results and the inaugural determination of our stress capital buffer at the minimum 2.5% level. The COVID-19 pandemic has provided an unprecedented, real-time, stress test and our strong capital position has enabled us to operate effectively, help stabilize the financial markets and support our employees, clients and communities. While the environment remains uncertain, State Street's performance under the Federal Reserve's severely adverse scenario is another reminder of our business model's resiliency and capital stability," said Chairman and Chief Executive Officer Ron O'Hanley. State Street's Board of Directors will consider the common stock dividend at a regularly scheduled board meeting in the third quarter of 2020. State Street's third quarter 2020 common stock and other stock dividends, including the declaration, timing and amount, remain subject to consideration and approval by State Street's Board of Directors at the relevant times.
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WFC | Hot Stocks16:37 EDT Wells Fargo sees Q3 dividend being reduced from current 51c per share level
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WFC | Hot Stocks16:36 EDT Wells Fargo sees SCB requirement to be 2.5% - Wells Fargo commented on the results of the Federal Reserve Board's Dodd-Frank Act stress test and related Comprehensive Capital Analysis and Review, including the FRB's instructions regarding capital distributions through the end of third quarter 2020. The company expects its common stock dividend in third quarter 2020 will be reduced from the current level of $0.51 per share. The company expects that the level of the third quarter dividend will be announced when it releases second quarter financial results on July 14, 2020. In addition, following the FRB's final publication of the CCAR results, the company expects its stress capital buffer to be 2.5%. The stress capital buffer represents a percentage amount of excess capital the company must hold above its minimum capital requirements beginning in October 2020. The stress capital buffer of 2.5% reflects a reduction in quarterly common stock dividends for the stress capital buffer period from the company's current level of $0.51 per share.
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MS | Hot Stocks16:36 EDT Morgan Stanley's CCAR results to require Stress Capital Buffer of 5.9% - The company states: "On June 25, 2020, the Board of Governors of the Federal Reserve System released its CCAR 2020 results and notified Morgan Stanley that it will be subject to a Stress Capital Buffer of 5.9% from October 1, 2020 to September 30, 2021. Together with other features of the regulatory capital framework, this SCB results in an aggregate U.S. Basel III Standardized Approach Common Equity Tier 1 ratio of 13.4%. The Firm's U.S. Basel III Standardized Approach CET1 ratio was 15.7% as of March 31, 2020. James Gorman, CEO, said, "The CCAR 2020 results affirm our strong capital position and reflect the stability of our business model. Our E*TRADE transaction will further diversify our business model and add to our excess capital and liquidity positions. We anticipate continuing to pay our quarterly common stock dividend of $0.35 per share. We voluntarily suspended our share repurchases in March and have continued to accrete capital. The updated capital rules provide us flexibility to deploy our excess capital, and we will reevaluate our capital actions when we have more confidence in the shape and path of the economic recovery. We will continue to invest in our businesses and support our clients, evidenced by the approximately $100 billion of incremental balance sheet that we have deployed since January 1, 2019."
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POAI | Hot Stocks16:36 EDT Predictive Oncology receives cash proceeds of $2.2M form warrant exercise - Predictive Oncology announced the closing of its previously announced transaction resulting in gross cash proceeds to the Company of approximately $2.2 million, prior to deducting placement agent fees and offering expenses, through the exercise of certain existing warrants by several holders to purchase an aggregate of up to 1,396,826 shares of common stock at an exercise price of $1.575 per share. The shares of common stock issued upon exercise of the existing warrants are registered for resale pursuant to a registration statement on Form S-1. In consideration for the immediate exercise of the existing warrants for cash, the exercising holders received new unregistered warrants to purchase up to an aggregate of 1,396,826 shares of common stock at an exercise price of $1.80 per share with an exercise period of five and one-half years from the date of issuance. The Company expects to use the net proceeds from this offering for working capital and general corporate purposes.
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BAC | Hot Stocks16:35 EDT Bank of America says preliminary SCB set at 2.5% effective Oct 1 - Bank of America commented on the results of the Federal Reserve's 2020 Comprehensive Capital Analysis and Review. The company continues to be well capitalized and able to serve clients, communities and businesses, even during times of severe economic and financial market stress. "Our decade-long focus on Responsible Growth has put us in a strong position to support consumers and businesses with capital and advice, while continuing to strengthen communities and deliver returns to shareholders through the economic cycle. This annual regulatory review, conducted since 2009, provides evidence to support that," said Bank of America Chairman and Chief Executive Officer Brian Moynihan. Based on its 2020 CCAR results, Bank of America will be subject to a preliminary 2.5% stress capital buffer for the period beginning October 1, 2020 and ending on September 30, 2021. In addition to the Basel 3 common equity tier 1 minimum of 4.5%, and the Global Systemically Important Bank Surcharge of 2.5%, this requires the company's CET1 ratio under applicable regulatory standards to remain above 9.5% during this period. The Federal Reserve has stated it expects to finalize the SCB for all firms by August 31, 2020.
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GS | Hot Stocks16:34 EDT Goldman Sachs says SCB requirement is 6.7% effective Oct 1 - On Thursday, June 25, the Federal Reserve notified the firm of the Stress Capital Buffer for The Goldman Sachs Group, Inc. of 6.7%, resulting in a Standardized Common Equity Tier 1 ratio requirement of 13.7%, which will become effective on October 1, 2020. In adapting to the capital requirements under the SCB, the firm remains committed to the medium and long-term strategic direction detailed at its Investor Day in January, including strengthening existing businesses, expanding into new and adjacent businesses, and operating with greater efficiency. "Our durable earnings profile, continued performance, and highly liquid balance sheet allow us to serve our clients, maintain our dividend, and deliver for all our stakeholders," said Chairman and CEO David Solomon. "We have a track record of rebuilding capital when necessary, and have brought our standardized CET1 ratio above 13% as this quarter comes to a close. We fully intend to continue this dynamic capital management while helping our clients continue to navigate challenging markets."
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SGEN | Hot Stocks16:33 EDT Seattle Genetics reports 'positive' results from Phase 2 tisotumab vedotin trial - Seattle Genetics every three weeks for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer. Results from the trial showed a 24 percent confirmed objective response rate by independent central review with a median duration of response of 8.3 months. The most common treatment-related adverse events included alopecia, epistaxis, nausea, conjunctivitis, fatigue and dry eye. The data will be submitted for presentation at an upcoming medical meeting. Tisotumab vedotin is an investigational antibody-drug conjugate directed to tissue factor, which is expressed on cervical cancer and can promote tumor growth, angiogenesis and metastases. Standard therapies for previously treated recurrent and/or metastatic cervical cancer generally result in limited objective response rates of typically less than 15 percent with median overall survival ranging from 6.0 to 9.4 months, in an all-comers population. Tisotumab vedotin is being developed by Seattle Genetics in collaboration with Genmab. "Available therapies upon progression after first line chemotherapy in recurrent or metastatic cervical cancer are limited, and there is a significant unmet need for new treatment options," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "Tisotumab vedotin has demonstrated clinically meaningful and durable objective responses with a manageable safety profile, and we look forward to discussing with the FDA the potential submission of a Biologics License Application to support an accelerated approval."
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UNVR | Hot Stocks16:33 EDT Univar appointed as distributor for Vink Chemical's Biocides in Brazil - Univar Solutions announced that it has reached an agreement with Vink Chemicals to distribute a portfolio of biocides in Brazil. The new authorization from Vink, a specialty biocide and biocidal products producer, includes brands appropriate for a wide variety of industries such as homecare and industrial cleaning, energy, and performance chemicals as well as coatings, adhesives, sealants, and elastomers.
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SYNC QUMU | Hot Stocks16:32 EDT Synacor and Qumu mutually terminate merger pact announced on February 11 - Synacor (SYNC) and Qumu (QUMU) announced that the companies have mutually agreed to terminate their proposed all-stock merger agreement, previously announced on February 11. QUMU and Synacor mutually agree to terminate proposed all-stock merger agreement. The termination was approved by the Boards of Directors of both companies. In a joint statement, Kevin Rendino, Chairman of Synacor, and Neil Cox, Chairman of Qumu, said, "We mutually concluded after careful consideration that it would not be prudent to continue to pursue the combination and integration of our companies. We are confident this is the right decision for our shareholders, our customers and our employees. This decision will ensure each of Synacor and Qumu can dedicate the resources and focus to pursue opportunities in their respective industries and businesses."
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HDS | Hot Stocks16:32 EDT HD Supply discloses SEC completed investigation, no enforcement recommended - The company states: "On June 24, 2020 the company received a letter from the staff of the Atlanta Regional office of the U.S. Securities and Exchange Commission confirming that the staff has completed its investigation of HD Supply Holdings, Inc. and, based upon the information the Staff has currently, does not intend to recommend to the Commission that an enforcement action be brought against the Company."
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C | Hot Stocks16:32 EDT Citi says SCB requirement will be 2.5% from 4Q20-3Q21 - The Federal Reserve Board communicated that Citi's interim Stress Capital Buffer requirement would be 2.5% for the four quarter window of 4Q 2020 - 3Q 2021. Incorporating this SCB, and a GSIB surcharge of 3%, results in a minimum regulatory requirement of 10% for both Standardized and Advanced Approaches relative to Citi's Common Equity Tier 1 ratio of 11.2% using Advanced Approaches as of the first quarter of 2020. Michael Corbat, Citi CEO, said, "These results are consistent with our expectations, and indicate that we have the capacity to withstand extreme stress. The strength of our franchise has allowed us to support our customers, clients and communities around the world as we navigate through this crisis, while maintaining significant capital and liquidity. While we will continue to evaluate our planned capital actions relative to the most recent financial and macroeconomic conditions, we believe we are well positioned to continue to support our customers and the broader economy, while also continuing with our planned capital actions. The planned capital actions include common dividends of $0.51 per share in the third quarter and over the four quarters covered by the 2020 CCAR cycle (i.e., 4Q 2020 - 3Q 2021), subject to the latest financial and macroeconomic conditions."
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COF | Hot Stocks16:31 EDT Capital One says Stress Capital Buffer Requirement is 5.6% effective Oct 1 - Capital One Financial Corporation announced the company's Stress Capital Buffer Requirement, as calculated by the Federal Reserve 2020 Comprehensive Capital Analysis and Review process, is 5.6%, effective October 1st, 2020.
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XLNX | Hot Stocks16:26 EDT Xilinx up over 6% at $98 per share after raising Q1 revenue view
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VRCA | Hot Stocks16:25 EDT Verrica reports FDA communicates 'deficiencies' in NDA for VP-102 - Verrica Pharmaceuticals announced that, on June 24 the company received a letter from the U.S. Food and Drug Administration as part of the FDA's ongoing review of the company's New Drug Application for VP-102, Verrica's lead product candidate for the treatment of molluscum contagiosum. The letter states that there are deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The letter further states that the notification does not reflect a final decision on the information under review. In a letter dated November 26, 2019, the FDA had assigned a Prescription Drug User Fee Act, or "PDUFA," goal date of July 13, 2020 for completion of its review of the NDA. "The FDA's letter does not identify any specific items. But, the company notes that information requests from the FDA during the NDA review have focused on CMC aspects of the drug-device combination. Verrica's ability to address these CMC-related requests, however, was significantly impacted in large part by the COVID-19 pandemic. The requests include, but are not limited to, a specific request related to a potential safety issue with the applicator that could arise if the instructions for use were not properly followed. In response, the company incorporated an additional user feature into the applicator to address that issue. The addition of that user feature, however, has affected human factors testing as well as requiring additional supportive stability data on the fully assembled device incorporating such feature. The company believes that both its long-term and registration stability data with the ampule, and the as-submitted applicator, support significant shelf life and stability for VP-102. The company anticipates interactions with, and additional communication from, the FDA and intends to work with the FDA to resolve and address any items as quickly as possible. Notwithstanding the pandemic or the CMC-related requests that have arisen during the review cycle, the company believes that the positive results from its two double-blind Phase 3 trials that evaluated the safety and efficacy of VP-102 compared to placebo in patients two years of age and older diagnosed with molluscum indicates that VP-102 remains viable for FDA approval," Verrica stated.
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VCRA | Hot Stocks16:22 EDT Correction: Vocera did not provide regulatory update - The previous headline "Vocera provides regulatory update on VP-102" was issued in error.
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MRK | Hot Stocks16:21 EDT Merck's Keytruda approves by FDA for first-line treatment of MSI-H, dMMR cancer - Merck announced that the U.S. Food and Drug Administration has approved KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer. The approval is based on results from the Phase 3 KEYNOTE-177 trial, in which KEYTRUDA significantly reduced the risk of disease progression or death by 40% compared with chemotherapy, the current standard of care. In the study, treatment with KEYTRUDA also more than doubled median progression-free survival compared with chemotherapy. "Today's approval has the potential to change the treatment paradigm for the first-line treatment of patients with MSI-H colorectal cancer, based on the important findings from KEYNOTE-177 that showed KEYTRUDA monotherapy demonstrated superior progression-free survival compared to standard of care chemotherapy," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "Our commitment to pursuing biomarker research continues to help us bring new treatments to patients, particularly for those who have few available options."
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BMRN | Hot Stocks16:21 EDT BioMarin promotes Brian Mueller to executive VP, CFO - BioMarin Pharmaceutical announced the promotions of Brian Mueller to executive VP, CFO and of Andrea Acosta to Group VP, Chief Accounting Officer. Mueller had been serving as senior VP, Acting CFO since February this year.
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ERII SLB | Hot Stocks16:21 EDT Energy recovery in pact with Schlumberger to exit from VorTeq deal - Energy Recovery (ERII) announced an agreement with Schlumberger (SLB) to exit its 15-year licensing deal for Schlumberger's exclusive use of Energy Recovery's VorTeq hydraulic pumping system. Under the terms of the new agreement, no further payments will be made by either party. Energy Recovery will now be fully responsible for commercialization of the VorTeq technology globally. At this time, the two parties have different strategic perspectives as to the path to VorTeq commercialization," said Robert Mao, Energy Recovery Chairman of the Board of Directors and President and Chief Executive Officer. "We believe this to be a positive outcome for all parties and are grateful to Schlumberger for their partnership through the years."
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BMRN | Hot Stocks16:17 EDT BioMarin names Brian Mueller as new CFO - BioMarin announced the promotions of Brian Mueller to Executive Vice President, CFO and of Andrea Acosta to Group Vice President, Chief Accounting Officer. Mr. Mueller had been serving as Senior Vice President, Acting CFO since February this year.
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MNR | Hot Stocks16:17 EDT Monmouth Real Estate reports occupancy rate, rent collection figures - Monmouth Real Estate reported that its occupancy rate from March 1 through June 30 averaged 99.4%. Rent collections throughout this period were as follows: March 100%, April 99%, May 98% and June 99%.
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ARYA | Hot Stocks16:17 EDT Arya Sciences Acquisition holders approve Immatics business combination - Arya Sciences Acquisition and Immatics Biotechnologies GmbH announced that its respective shareholders approved the business combination between Arya and Immatics announced on March 17, 2020. None of Arya's shareholders redeemed their shares in connection with the ARYA shareholder approval. The respective boards of directors of both Arya and Immatics had previously approved the business combination. Following the Arya shareholder vote, Immatics and Arya commenced final procedures towards the closing of the business combination and expect the closing to be completed in the coming days. It is further expected that the trading of the shares of the combined company, called Immatics N.V., will commence under the symbol "IMTX" on the first trading day thereafter. Immatics will continue to operate under its existing management team led by Chief Executive Officer, Harpreet Singh, Ph.D.
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MSGE | Hot Stocks16:16 EDT MSG Entertainment names Scott Packman as General Counsel - Madison Square Garden Entertainment announced that Scott Packman has been named Executive Vice President and General Counsel, effective July 1. In this role, Mr. Packman will oversee and direct all of MSG Entertainment's legal affairs, supporting the company's growth initiatives.
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AIZ | Hot Stocks16:16 EDT Assurant finalizes 2020 property catastrophe reinsurance program - Assurant announced it has finalized its 2020 property catastrophe reinsurance program, limiting the company's financial exposure and protecting more than 3 million homeowners and renters policyholders against severe weather and other hazards. "At Assurant, not only is our commitment to social responsibility critical, but we believe we have an obligation to strengthen and protect the communities where we work and live for all of our stakeholders, including our customers and consumers," said Assurant President and Chief Executive Officer Alan Colberg. "And one way we demonstrate that commitment is by implementing a comprehensive catastrophe reinsurance program." Michael Campbell, President of Global Housing added, "This year, our strong reinsurance partnerships enabled us to increase our multi-year coverage to nearly 50 percent of our total U.S. program, while maintaining our $80 million per-event retention at attractive terms and conditions, compared to the broader market. Importantly, we continued to execute on our long-term strategy to reduce less attractive risk exposure, as we exited businesses that do not meet our risk-return expectations, allowing us to lower our overall tower limit by $230 million."
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VCRA | Hot Stocks16:15 EDT Vocera provides regulatory update on VP-102 - Verrica Pharmaceuticals announced that, on June 24, the Company received a letter from the U.S. Food and Drug Administration as part of the FDA's ongoing review of the Company's New Drug Application for VP-102, Verrica's lead product candidate for the treatment of molluscum contagiosum. The letter states that there are deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The letter further states that the notification does not reflect a final decision on the information under review. In a letter dated November 26, 2019, the FDA had assigned a Prescription Drug User Fee Act goal date of July 13 for completion of its review of the NDA. The FDA's letter does not identify any specific items. But, the Company notes that information requests from the FDA during the NDA review have focused on CMC aspects of the drug-device combination. Verrica's ability to address these CMC-related requests, however, was significantly impacted in large part by the COVID-19 pandemic. The Company anticipates interactions with, and additional communication from, the FDA and intends to work with the FDA to resolve and address any items as quickly as possible.
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OCX | Hot Stocks16:15 EDT OncoCyte DetermaDx did not meet endpoints of clinical validation study - Oncocyte announced the completion of the clinical validation study of DetermaDx, the company's liquid biopsy test intended to clarify whether a lung nodule is suspicious or likely benign. Findings from the study demonstrated that the performance of DetermaDx did not meet the predetermined endpoints for the study. DetermaRx, intended for treatment selection in early stage lung cancer management, is launched for clinical use. It is covered by Medicare, has been reimbursed by several commercial payers and is gaining traction in community-based health systems despite the challenges in the macroenvironment relating to the COVID-19 pandemic. This test has a global opportunity of more than 350,000 patients annually and a worldwide market size of over $500M. The second test is DetermaIO for immunotherapy response prediction, with studies completed in non-small cell lung cancer and triple negative breast cancer by researchers at the West Clinic and MD Anderson Cancer Center, respectively, with results presented at SITC 2019 and the ASCO 2020 annual meetings. This test is currently available for biopharma diagnostic development and research use only and has significant potential as a companion test to select patients for clinical trials and, ultimately, as a full companion diagnostic for clinical use of immunotherapies in patient management. CEO Ron Andrews said, "Based on the results of the Clinical Validation study, we have made the decision to cease further investment in DetermaDx and focus our efforts on maximizing the significant opportunities that we see for our two more advanced commercial tests. We have a balanced portfolio of tests in market launch phases and are enthusiastic about the Company's progress over the last year and our future prospects."
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SGMS | Hot Stocks16:14 EDT Scientific Games appoints Eileen Moore Johnson Chief Human Resources Officer - Scientific Games Corporation announced that Eileen Moore Johnson will join the global gaming entertainment company as executive VP and Chief Human Resources Officer. Moore Johnson joins Scientific Games from Caesars Entertainment where she served as Regional President of The Cromwell, Flamingo, Harrah's and The LINQ resorts.
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MU | Hot Stocks16:12 EDT Micron sees data center outlook remaining healthy - "Looking ahead to the second half of calendar 2020, let me discuss certain key market trends," said Micron CEO Sanjay Mehrotra. "First, we expect the data center outlook to remain healthy. Second, we expect smartphone and consumer end-unit sales to continue to improve, accelerating inventory consumption across the supply chain. And third, new gaming consoles will drive stronger DRAM and NAND demand. Despite these trends, our short-term visibility across end markets remains limited due to COVID-19, macro and trade uncertainties, as well as customer inventory changes. The recent restrictions on Huawei are also impacting our opportunity in the near term. As these risks recede, we expect a resumption of industry growth, with a long-term bit growth CAGR of mid to high teens for DRAM and approximately 30% for NAND. This growth will be supported by powerful secular technology trends ranging from AI and machine learning to cloud computing, 5G and the growth in edge computing, and the industrial IoT economy. Turning to industry supply, second-half 2020 supply growth may be somewhat muted compared to preCOVID-19 expectations. Some suppliers have commented about delays in equipment deliveries, which can result in slower node transitions and lower bit growth. Specific to Micron, we are proactively aligning our bit supply to market demand. Our FY20 front-end equipment CapEx is down more than 40% from FY19 and is at its lowest level in the last 5 years. While we expect to increase FY21 CapEx to support high ROIC node transitions, this capex will be meaningfully lower than our pre-COVID-19 plan. We have also made changes to our DRAM utilization to align with the current lower demand in the automotive market. As end-market conditions evolve, we will remain flexible to make any needed adjustments to our supply."
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SPG | Hot Stocks16:12 EDT Simon Property provides update, declares Q2 dividend - Simon provided an update on the reopening of the company's retail properties and declared a common stock dividend for Q2. Simon has reopened 199 of its 204 U.S. retail properties in 37 states which represent more than 95% of the company's property net operating income. These properties are located where governmental orders have enabled reopening and the remaining five properties are expected to reopen within the next week. More than 18,000 stores across the company's U.S. portfolio have reopened. Since reopening, many tenants have reported higher-than-expected conversion rates and sales. In addition, 30 of Simon's Designer and international Premium Outlets properties are open, including all of the company's international Premium Outlets in Asia and Designer Outlets in Continental Europe, with nearly 100% of retail stores open. The last remaining international Premium Outlet is expected to open next week. The company recently announced the grand opening of Siam Premium Outlets Bangkok, marking Thailand's first Premium Outlet center. The company maintains a strong liquidity position of approximately $8.5B, consisting of approximately $3.5B of cash on hand, including its share of joint venture cash, and $5.0B of available capacity under its revolving credit facilities and term loan, net of outstanding U.S. and Euro commercial paper as of May 31. Simon's board declared a $1.30 per common share dividend, payable in cash, for Q2. The dividend will be payable on July 24 to shareholders of record at the close of business on July 10. The company expects to pay at least $6.00 per share in common stock dividends for 2020, in cash, subject to board approval.
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CATB | Hot Stocks16:10 EDT Catabasis Pharmaceuticals joins Russell 3000 Index - Catabasis Pharmaceuticals announced that it has joined the broad-market Russell 3000 Index at the conclusion of the 2020 Russell Indexes annual reconstitution, effective after the US market opened today.
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JEF | Hot Stocks16:10 EDT Jefferies Financial Group authorizes additional $250M stock buyback - The company states: "We repurchased 10.1M shares for $166M, or an average price of $16.42 per share, including the 8.0 million shares repurchased early in March and previously disclosed; a further $250M now authorized for repurchase."
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MU | Hot Stocks16:10 EDT Micron says pandemic has impacted cyclical recovery in DRAM, NAND - "The pandemic has impacted the cyclical recovery in DRAM and NAND, causing stronger demand in some segments and weaker demand in others," the company said. "Market segments driven primarily by consumer demand have seen a negative impact. Calendar 2020 analyst estimates for end-unit sales of autos, smartphones and PCs are meaningfully lower than pre-COVID-19 levels, even though estimates for enterprise laptops and Chromebooks have increased. The reduced level of global economic activity has also curtailed near-term demand. The pandemic is driving rapid change in consumer and corporate practices around the world. Consumers are significantly increasing online activity, including e-commerce, gaming and video streaming, all of which drive additional data center capacity requirements. Trends like working-from-home and online learning are likely to drive long-term changes in how we think about workforce flexibility and education. Several governments around the world are considering ways to ensure a level playing field by considering significant programs that provide Chromebooks or tablets to students who cannot afford them, as online learning becomes a necessity in these times. Additional government fiscal stimulus programs are also supportive of economic activity and will accelerate trends like electric vehicle production. Emerging technologies such as drone-based deliveries and the increased use of robotics across many applications are now being pursued with urgency. Technology solutions are rapidly helping society adapt and manage the temporary and permanent changes stemming from this pandemic. Clearly, certain trends that would have taken 2 to 4 years to develop have been accelerated into months. It is easy to see how these changes will drive higher consumption of memory and storage in the long term. The faster pace of digital transformation in the economy is here to stay." Comments taken from Q3 conference call prepared remarks.
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AVA | Hot Stocks16:08 EDT Avista announces 10-year wildfire resiliency plan - Avista is implementing additional measures to enhance its ability to mitigate the potential for, and impact of, wildfires within its service territories. Building on prevention and response strategies that have been in place many years, the company has committed to a new comprehensive 10-year wildfire resiliency plan that includes improved defense strategies and operating practices for a more resilient system. Avista spent the last year developing its plan through a series of internal workshops, industry research and engagement with state and local fire agencies. Improvements to infrastructure and operational practices were identified as key components to the plan. The formalized plan emphasizes continued collaboration with land-management and fire-response agencies. It promotes increased public and worker safety as well as protection of physical assets and property. It also identifies measures to further minimize service disruptions caused by wildfires and other extreme weather events.
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SYNC QUMU | Hot Stocks16:07 EDT Synacor, Qumu terminate merger agreement - Synacor (SYNC) and Qumu (QUMU) announced that the companies have mutually agreed to terminate their proposed all-stock merger agreement, previously announced on February 11, 2020. The termination was approved by the Boards of Directors of both companies.
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LULU | Hot Stocks16:06 EDT Lululemon to acquire MIRROR for $500M - Lululemon Athletica announced that it has entered into a definitive agreement to acquire MIRROR, an in-home fitness company that created an interactive workout platform that features live and on-demand classes, for a purchase price of $500M. Calvin McDonald, Chief Executive Officer, commented, "In 2019, we detailed our vision to be the experiential brand that ignites a community of people living the sweatlife through sweat, grow and connect. The acquisition of MIRROR is an exciting opportunity to build upon that vision, enhance our digital and interactive capabilities, and deepen our roots in the sweatlife. We look forward to learning from and working with Brynn Putnam and the team at MIRROR to accelerate the growth of personalized in-home fitness." This transaction builds on a successful partnership between the two companies, which began in mid-2019 with an initial investment in MIRROR by lululemon, and also includes a content partnership which brought sweat and meditation classes to the MIRROR platform by lululemon's Global Ambassadors. This acquisition will further expand the content creation partnership between the two brands and will help lululemon, MIRROR and lululemon Ambassadors reach new guests. The purchase price is expected to be paid from the company's primary sources of liquidity, which include over $800M in cash, its existing $400M revolving credit facility, and a new one-year, $300M revolving credit facility. Following completion of the transaction, MIRROR will operate as a standalone company within lululemon and Ms. Putnam will continue as MIRROR's chief executive officer, reporting to Mr. McDonald. The transaction is subject to customary closing conditions and is expected to close in the second quarter of fiscal 2020.
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LQDA | Hot Stocks16:04 EDT Liquidia to acquire RareGen and expand presence in PAH - Liquidia Technologies announced it has entered into a definitive agreement to acquire RareGen,, a portfolio company of PBM Capital, through an all-stock merger. Liquidia and RareGen will consolidate under a new holding company, to be named Liquidia Corporation, which is expected to trade on the Nasdaq Capital Market under the ticker symbol "LQDA," as the successor to Liquidia Technologies. RareGen provides strategy, investment, and commercialization for rare disease pharmaceutical products. RareGen has a small, targeted sales force focused on PAH. RareGen acquired the right to promote Sandoz's first-to-file generic of Remodulin for the treatment of patients with PAH. In March 2019, Sandoz and RareGen launched their generic treprostinil injection, making it the first generic of Remodulin to market. Liquidia Corporation will assume RareGen's responsibilities under the agreement with Sandoz following closing of the merger transaction. This acquisition reinforces Liquidia's commitment to the PAH community and continued pursuit to address the unmet needs of patients and the healthcare professionals who treat them. The potential introduction of LIQ861 as a more convenient inhaled treprostinil over the currently available inhaled option, combined with RareGen's parenteral treprostinil option emphasize Liquidia's commitment to addressing the patient continuum of treatment. In addition, these combined entities further enhance the organization's knowledge base, customer reach and commercial planning in preparation for the potential launch of LIQ861, if approved.
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LMNX | Hot Stocks16:02 EDT Luminex submits EUA request to FDA for COVID-19 antibody test - Luminex Corporation announced that the company has submitted an Emergency Use Authorization, or EUA, request to the FDA for its xMAP SARS-CoV-2 Multi-Antigen IgG assay. The assay was developed to provide additional capacity to detect antibodies in patients who may have been exposed to or infected by SARS-CoV-2. It delivers results for up to 96 samples in under three hours and is designed to be run on all xMAP platforms, with more than 17,000 systems sold globally, and 65+ Luminex global partners offering 1,300+ kits and custom assay solutions.
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MRK | Hot Stocks15:37 EDT FDA approves Keytruda as first-line therapy for certain colorectal cancers - The U.S. Food and Drug Administration approved Keytruda for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high, or MSI-H, or mismatch repair deficient, or dMMR, colorectal cancer. "This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy," the FDA said. The FDA granted this approval of Keytruda to Merck.
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ROKU T | Hot Stocks15:22 EDT Roku weakness attributed to rise in HBO Max streaming - Roku (ROKU) shares are down the most in over six weeks today, noted Bloomberg, which reported an analysis of Apptopia data showed that AT&T's (T) HBO Max had the biggest increase in video streaming last week with a 12% increase in mobile app users. That compares to Roku's 0.9% increase, said Bloomberg, which added that HBO Max does not have its own app available for Roku's platform. In late afternoon trading, Roku shares are down $9.80, or 8%, to $112.75.
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HPQ FB | Hot Stocks15:12 EDT HP Inc. stopping U.S. advertising on Facebook, to review social media strategy - HP Inc. (HPQ) issued the following statement on social media advertising on its corporate site: "HP is a purpose-driven brand and we expect all platforms on which we advertise to uphold responsible policies that prevent our ads from appearing alongside objectionable content, regardless of the source. We have expressed deep concerns to Facebook and are stopping U.S. advertising on the platform until we see more robust safeguards in place. We are also reviewing our social media strategy across all markets and platforms, and we will take additional actions as needed to protect our brand and combat hateful content." Reference Link
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NYT AAPL | Hot Stocks14:22 EDT New York Times exits partnership with Apple News - The New York Times (NYT) said that it will exit its partnership with Apple News (AAPL), as news organizations struggle to compete with big tech firms. Beginning Monday, Times stories were no longer appearing alongside other publications' stories in the curated Apple News feed on Apple devices. "Core to a healthy model between The Times and the platforms is a direct path for sending those readers back into our environments, where we control the presentation of our report, the relationships with our readers, and the nature of our business rules," Meredith Kopit Levien, chief operating officer, wrote in a memo to employees. "Our relationship with Apple News does not fit within these parameters." Reference Link
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NYT AAPL | Hot Stocks14:21 EDT New York Times exits partnership with Apple News - The New York Times (NYT) said that it will exit its partnership with Apple News (AAPL), as news organizations struggle to compete with big tech firms. Beginning Monday, Times stories were no longer appearing alongside other publications' stories in the curated Apple News feed on Apple devices. "Core to a healthy model between The Times and the platforms is a direct path for sending those readers back into our environments, where we control the presentation of our report, the relationships with our readers, and the nature of our business rules," Meredith Kopit Levien, chief operating officer, wrote in a memo to employees. "Our relationship with Apple News does not fit within these parameters."
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GILD ABC | Hot Stocks14:16 EDT HHS secures over 500,000 treatment courses of Remdesivir - The Department of Health and Human Services announced an agreement to secure "large supplies" of Remdesivir for the United States from Gilead Sciences (GILD) through September, "allowing American hospitals to purchase the drug in amounts allocated by HHS and state health departments." HHS has secured more than 500,000 treatment courses of the drug for American hospitals through September, the agency said in a statement. This represents 100% of Gilead's projected production for July, 90% of production in August, and 90% of production in September, in addition to an allocation for clinical trials, it added.. A treatment course of remdesivir is, on average, 6.25 vials. Hospitals will receive the product shipped by AmerisourceBergen (ABC) and will pay no more than Gilead's wholesale acquisition price, which amounts to approximately $3,200 per treatment course, the HHS said. Reference Link
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FB | Hot Stocks14:10 EDT Facebook up 2% after acknowledging more work needed on platform safety
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FB | Hot Stocks14:09 EDT Facebook intends to include prevalence of hate speech in reports - Facebook said in a statement, "In May, we made the announcement our Community Standards Enforcement Report (CSER) is moving to a quarterly basis. The next report will be released in August. This detailed report showcases how we are doing at removing content that violates our Community Standards, in more detail than any other major internet service. As part of our ongoing commitment to transparency we intend to include the prevalence of hate speech in our CSER reports over the coming year, pending no further complications from COVID-19. As Mark said in February, we're also looking at opening up our content moderation systems for external audit. We're reaching out to key stakeholders spanning government regulators, civil society, and the advertising industry as this is designed. This separate third-party audit will be completed by a reputable firm and include the incidence of violating content. We are in the early days of this process and will share more details as we are able."
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FB | Hot Stocks14:08 EDT Facebook to evaluate partner and content monetization policies - Facebook said in a statement, "We plan to evaluate our partner and content monetization policies and the brand safety controls we make available to advertisers. This audit, run by the Media Rating Council, will include (but not be limited to): An evaluation of the development and enforcement of our Partner Monetization Policies; An evaluation of the development and enforcement of our Content Monetization Policies and how these policies enforce the 4A's/GARM Brand Suitability Framework, and comply with MRC's Standards for Brand Safety; An assessment of our ability to apply brand safety controls to ads shown within publisher content such as in-stream, Instant Articles or Audience Network; A determination of the accuracy of our available reporting in these areas We will share an update on the scope and timing of this audit once finalized with the MRC."
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FB | Hot Stocks14:06 EDT Facebook acknowledges 'much more work to do' on keeping platform safe - Facebook said in a statement, "We recognize our responsibility to facilitate a safe environment for everyone using our platforms. To do this, we have to provide our partners with transparency of how well we are doing at keeping the platform safe by removing violating content. We have work underway to address the major concerns expressed but acknowledge there is much more work to do."
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AMC | Hot Stocks14:06 EDT AMC announces new U.S. reopening date of July 30 - AMC Theatres announced a new U.S. reopening date of July 30, when it will resume operations of 450 U.S. theatres as part of a phased plan that is expected to bring the 600-plus U.S. theatre circuit essentially to full operation by early August. The new reopening date aligns with updated release timing for major theatrical blockbusters Warner Bros' TENET (August 12) and Disney's MULAN (August 21). AMC is also excited to offer movie-goers a broad selection of other new releases in July and August, including Solstice's action thriller UNHINGED (July 31), Sony's romantic comedy THE BROKEN HEARTS GALLERY (August 7), A24's psychological horror film SAINT MAUD, Disney/Marvel's action fantasy film NEW MUTANTS (August 28), Picturehouse's inspirational drama FATIMA (August 28), Orion's comedy BILL AND TED FACE THE MUSIC (August 28), and others. Additionally, Warner Bros. will celebrate the 10th anniversary of Christopher Nolan's INCEPTION with a re-release on July 31st. Once the U.S. reopening commences, AMC will have theatres open in all 15 countries in which AMC operates. Theatres in all 14 countries AMC serves in Europe and the Middle East either opened in June or are planned to open in July as well. Barring further complications from the coronavirus outbreak, AMC expects to be open at essentially its full complement of approximately 1,000 theatres globally by early August. Adam Aron, CEO & President, AMC Theatres said, "We continue to devote extraordinary resources into our plan to operate our theatres with a hyper commitment to the safety and health of our guests and associates, notably in the United States through our new AMC Safe & Clean initiative. Our theatre general managers across the U.S. started working full time again today and are back in their theatres gearing up to get their buildings fully ready just a few weeks from now for moviegoers. That happy day, when we can welcome guests back into most of our U.S. theatres, will be Thursday, July 30."
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FB | Hot Stocks14:04 EDT Facebook shares updates on making 'systems more transparent'
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IMTE | Hot Stocks14:03 EDT Integrated Media Technology evaluating options to resolve listing deficiency - Integrated Media Technology announces that on June 19 the company received a written notice from the Listing Qualifications Department of The Nasdaq Stock Market advising the company that, based upon its annual report on Form 20-F for the fiscal year ended December 31, 2019, the reported stockholders' equity of approximately $55,322 does not meet the requirement of a minimum of $2,500,000 in stockholders' equity for continued listing requirement set forth in Nasdaq Listing Rules. The notification also stated that the company would be provided 45 days to submit a plan to regain compliance with the listing requirement. If the plan is accepted, the company can be granted up to 180 calendar days from the date of the Notice to evidence compliance. If the company is unable to evidence compliance in that period, the Nasdaq Staff will provide the company with written notification that its securities are subject to delisting from The Nasdaq Capital Market. "The company is currently evaluating its available options to resolve the deficiency and regain compliance with the Nasdaq minimum stockholders' equity requirement," Integrated Media stated.
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UHAL | Hot Stocks14:02 EDT U-Haul to bring new self-storage center to St. Augustine - U-Haul is bringing a retail and self-storage facility to St. Augustine with its recent land acquisition on the south side of CR 16A and the north side of SR 16. U-Haul Moving & Storage of Mill Creek will offer truck and trailer sharing, towing equipment, moving supplies and U-Box portable storage containers. There will be more than 1,000 self-storage units for rent with climate-control options and high-tech security features at affordable price points. The 100,000-square-foot building is expected to be completed by fall 2021.
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GE | Hot Stocks14:02 EDT GE Aviation awarded $203M contract from Japan Ministry of Defense - GE Aviation Distribution Japan said it has been awarded a contract valued at $203M from the Japan Ministry of Defense for CF6-80C2K1F Propulsion Systems to power Japan Air Self-Defense Force C-2 transport aircraft. The contract includes 12 units due for deliveries, starting from late 2021. Reference Link
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CNSL | Hot Stocks14:01 EDT Consolidated Communications introduces CCiTV in Texas - Consolidated Communications introduced CCiTV to residential and small and medium business customers in its Texas service areas. "We're excited to bring this new, one-of-a-kind TV service to Texas," said Rob Koester, senior vice president of consumer product management at Consolidated Communications. "CCiTV breaks the traditional mold of television services by removing the two biggest pain points customers experience when dealing with traditional providers - weather-related outages and never-ending fees on the bill. Customers have the flexibility to watch on a TV, computer, tablet or phone and use their own streaming device, like Amazon Fire TV and Apple TV, or receive a set-top box from Consolidated." Consolidated's CCiTV provides a fully customizable, cloud-enabled TV experience that supports individual preferences, parental controls and viewing recommendations. The service's bring-your-own-device functionality creates a highly flexible in-home viewing experience that serves a wide variety of viewing habits. It can be delivered in high-definition quality to a big-screen TV, as well as to tablets and mobile devices through compatibility with a wide variety of Apple iOS-, Amazon- and Android-supported devices. CCiTV delivers content from the most popular networks including: A+E, USA, FX, ESPN, Longhorn Network, HBO, Showtime, local broadcast channels, regional sports networks and others.
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RICK | Hot Stocks13:53 EDT RCI Hospitality CEO says 'well positioned to weather temporary closings' - RCI Hospitality announced new reopenings and closings of subsidiary locations in response to changing COVID-19 conditions and regulations in different regions. Eric Langan, President & CEO, said, "Based on a combination of revenues generated, locations currently operating and those anticipated to reopen, and cash on hand, we believe we are well positioned to weather temporary closings due to regional conditions. We anticipate having approximately $12M-$13M in cash as of June 30. Revenues have grown eight consecutive weeks from approximately $500,000 in May when Bombshells first started to open, to more than approximately $2.4M the week ending June 21st. Sales for last week were approximately $1.8M due to the transition between reopenings and closings. Some softness is typical through the July 4th holiday. After that, we hope to resume growth, especially if there is enough progress with Covid-19 where our subsidiaries operate to enable reopenings. Since reopenings started, there have been temporary voluntary closures. Subsidiaries have learned from and dealt with them, and they haven't disrupted operations. Looking ahead, there may be other temporary closings ordered in various regions of the country, but we believe we are geographically diverse enough to deal with them, too. We are disappointed at our subsidiaries' staff being laid off again at certain locations but pleased to report quick recovery times for all those who have had the coronavirus, and we hope that trend continues. We also hope government officials will only keep bars closed for a short time so staff at affected subsidiaries will be able to return to earning a living as quickly as possible." RCI said it plans to report club and restaurant sales for the third quarter ending June 30 on July 9.
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NIO | Hot Stocks13:53 EDT NIO jumps after announcing 'substantial' cash 'injections' in June - Shares of EV maker NIO are up 4% to $7.21 per share in afternoon trading on Monday after announcing earlier that investors have substantially completed the cash injection obligations for the first two installments of their investments in NIO China. NIO Holding, or NIO Anhui, the legal entity of NIO China wholly owned by the Company prior to the investments, has received from the investors RMB4.8B out of the RMB5 billion of cash investments for the first two installments. Under the definitive agreements, as amended and supplemented, the investors will inject an aggregate of RMB7 billion in cash into NIO Anhui. NIO will inject its core businesses and assets in China, including vehicle research and development, supply chain, sales and services and NIO Power, or together as the Asset Consideration, into NIO Anhui. Further, the Company will inject RMB4.26 billion in cash into NIO Anhui. Upon the completion of the investments, NIO will hold 75.885% of controlling equity interests in NIO China, and the Strategic Investors will collectively hold the remaining 24.115%.
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NKLA | Hot Stocks13:41 EDT EV maker Nikola jumped over 10% after announcing Badger preorders open June 29 - Shares Nikola are trading at $68 per share currently but jumped as high as $72 per share earlier after announcing preorders are now being accepted at 11 AM ET on June 29. Preorders received before November 15, 2020 will also be entered to win a Badger, receive a match of your deposit, up to $5,000 off the final purchase price of the vehicle, and be invited to the Badger debut at Nikola World, which is slated for December 3-5, 2020 in Phoenix, Ariz. "The technology on the Badger is next to none; it has one of the most advanced powertrains and infotainment systems on the market. The features include over-the-air updates, keyless entry, independent torque control of every wheel, 906 HP, 980 ft. lbs. of torque, 15 kilowatt power export with 220V and 110V, tie-down tracks inside the truck for cargo, hidden refrigerator, up to 600 miles of range, and waterproof displays. You couldn't dream of building a better pickup truck than the Badger and we offer it in both fuel cell and battery-electric options," said Founder and Executive Chairman Trevor Milton. "At Nikola World 2020, our followers will have the chance to see the Badger in action, so you don't want to miss this show."
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IAG | Hot Stocks13:30 EDT IAMGold attains milestone in permitting for Cote Gold project - IAMGold Corporation confirms that it has received approval for its application under Section 36 of the Fisheries Act, Canada, for the Cote Gold Project, "a key milestone in attaining permits relating to impacts on fish habitats and tailings management. Final publication of the amended Schedule 2 of the Metal and Diamond Mining Effluent Regulations is expected on July 8. Cote, located in northern Ontario, is a 70/30 Joint Ventur with Sumitomo Metal Mining, demonstrating potential to produce 460,000 ounces of gold annually at low all-in sustaining costs of approximately $700 per ounce in the first six years of production with a 16-year mine life. The JV has been very active in de-risking the Project since the feasibility study was published in late 2018 ;The Company's share of the anticipated go-forward range for capital is $875 - 925 millionour proposed growth plans, with over $800 million in cash on hand, access to a currently undrawn $500 million committed revolving credit facility, and expected stronger operating cash flows from our current mining operations, including anticipated contributions from Saramacca at Rosebel and steady performance from Essakane and Westwood." Addressing the Boto Gold Project, Mr. Stothart commented, "In Senegal, we are actively engaged in advancing Boto through a disciplined, staged approach, building essential initial infrastructure to secure access to the site, and further de-risking the Project as we have successfully done for Cote."
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CLX FB | Hot Stocks13:21 EDT Clorox to stop advertising spending with Facebook through December - In a post to its corporate blog entitled "Clorox's Response to Hate Speech," the company stated: "The Clorox Company will stop advertising spending with Facebook through December. As a people-centered company committed to our values, we feel compelled to take action against hate speech, which we believe will increase through the balance of the year. This creates an increasingly unhealthy environment for people and our purpose-driven brands. We will maintain our planned level of advertising spending but shift to other media. We will continue to monitor this situation and revisit our position as needed. In the meantime, we will evolve our standards and guidelines for progress for all platforms and publishers to reflect our rising expectations for greater responsibility as these channels continue to become a more important part of people's lives." Reference Link
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CLX | Hot Stocks13:17 EDT Clorox to stop advertising spending with Facebook through December - In a post to its corporate blog entitled "Clorox's Response to Hate Speech," the company stated: "The Clorox Company will stop advertising spending with Facebook through December. As a people-centered company committed to our values, we feel compelled to take action against hate speech, which we believe will increase through the balance of the year. This creates an increasingly unhealthy environment for people and our purpose-driven brands. We will maintain our planned level of advertising spending but shift to other media. We will continue to monitor this situation and revisit our position as needed. In the meantime, we will evolve our standards and guidelines for progress for all platforms and publishers to reflect our rising expectations for greater responsibility as these channels continue to become a more important part of people's lives." Reference Link
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LLEX | Hot Stocks13:12 EDT NYSE American suspends trading in Lilis Energy, commences delisting - NYSE American announced that the staff of NYSE Regulation has determined to commence proceedings to delist the common stock of Lilis Energy, ticker symbol "LLEX", from the Exchange. Trading in the Company's common stock on the NYSE American will be suspended immediately. NYSE Regulation has determined that the Company is no longer suitable for listing and will commence delisting proceedings pursuant to Section 1003(c)(iii) of the NYSE American Company Guide. On June 29, 2020, the Company announced that it had filed petitions under Chapter 11 of the United States Bankruptcy Code to initiate voluntary cases in the United States Bankruptcy Court for the Southern District of Texas. NYSE Regulation noted the uncertainty as to the timing and outcome of the bankruptcy process, as well as the ultimate effect of this process on the value of the Company's common stock. The Company has a right to a review of staff's determination to delist the common stock by a committee of the Board of Directors of the Exchange. The NYSE American will apply to the Securities and Exchange Commission to delist the Company's common stock upon completion of all applicable procedures, including any appeal by the Company of the NYSE Regulation staff's decision.
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CHK | Hot Stocks13:10 EDT NYSE suspends Chesapeake trading, to commence delisting proceedings - The New York Stock Exchange announced that the staff of NYSE Regulation has determined to commence proceedings to delist the common stock of Chesapeake Energy - ticker symbol CHK - from the NYSE. Trading in the company's common stock will be suspended immediately. NYSE Regulation reached its decision that the company is no longer suitable for listing after the company's June 28 disclosure that the company filed voluntary petitions for reorganization under Chapter 11 of the Bankruptcy Code in the United States Bankruptcy Court for the Southern District of Texas. In reaching its delisting determination, NYSE Regulation noted the uncertainty as to the ultimate effect of this process on the value of the company's common stock. NYSE Regulation also noted that, under the consensual plan of reorganization, each holder of equity interest in the company would have such interest cancelled, released, and extinguished without distribution.
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HALO RHHBY | Hot Stocks12:59 EDT Halozyme announces FDA approval of Roche's Phesgo with Enhanze technology - Halozyme Therapeutics (HALO) announced that the U.S. FDA has approved Roche's (RHHBY) Phesgo injection, a fixed-dose combination of Perjeta and Herceptin with Halozyme's ENHANZE technology, administered subcutaneously in combination with intravenous chemotherapy, for the treatment of eligible patients with early and metastatic HER2-positive breast cancer. This is the first time a product has been approved combining two monoclonal antibodies that can be administered by a single subcutaneous injection utilizing Halozyme's ENHANZE technology. "We are excited that HER2-positive breast cancer patients in the U.S. will now have the option to receive this important therapy in a meaningfully shorter period of time," said Dr. Helen Torley, president and CEO. "This subcutaneous delivery was shown to be preferred to IV administration by 85% of patients in the PHranceSCa study due to less time in the clinic and more comfortable treatment administration. Phesgo is the second product to receive FDA approval this year, and the first demonstrating the ability to combine two monoclonal antibodies, utilizing our ENHANZE technology."
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LNG | Hot Stocks12:59 EDT DOT says Cheniere can commission Train 3 fuel gas system - The Department of Transportation notified Cheniere Energy that its June 16 request for Corpus Christi Liquefaction to introduce gas and commission the Train 3 fuel gas system has been granted. Shars of Cheniere Energy are up 4% to $46.88 in afternoon trading. Reference Link
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RHHBY | Hot Stocks12:54 EDT FDA approves Genentech's Phesgo for HER2-positive breast cancer - Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has approved Phesgo, a fixed-dose combination of Perjeta and Herceptin with hyaluronidase, administered by subcutaneous injection in combination with intravenous chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Genentech has combined two monoclonal antibodies that can be administered by a single SC injection. "The FDA approval of Phesgo reflects our commitment to improving outcomes for the many people living with HER2-positive breast cancer," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "Phesgo offers a treatment administration that supports the needs and preferences of individual patients, and helps to meet the increasing demand across the healthcare system for faster and more flexible treatment options." The approval is based on results from the pivotal Phase III FeDeriCa study, which met its primary endpoint with Phesgo showing non-inferior levels of Perjeta in the blood during a given dosing interval when compared to IV administration of Perjeta. The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity.
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IPATF | Hot Stocks12:50 EDT IPA confirms discovery of human, neutralizing antibodies targeting SARS-CoV-2 - ImmunoPrecise announced the identification of numerous lead candidate antibodies with highly-potent neutralizing activity in vitro, which are being manufactured for further testing and possible inclusion in the Company's PolyTope mAb Therapy to combat the COVID-19 pandemic. On March 12th, 2020, ImmunoPrecise announced several preclinical programs currently being undertaken to assist in the efforts against SARS-CoV-2. Today's announcement updates the company's progress on the development of a PolyTope mAb therapy designed to treat severely ill patients, as well as protect high-risk individuals such as those exposed to the virus, front-line workers, the elderly, and the immunocompromised. "Arriving at this critical point in our preliminary research with many lead, functional therapeutic candidates is indicative of the broad scientific scope of IPA's anti-COVID-19 programs," stated Dr. Jennifer Bath, CEO and President of IPA. "An effective cocktail therapy for COVID-19, targeting multiple epitopes on the virus, could prove fundamental in combating this pandemic in an effective and enduring way."
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PLNT | Hot Stocks12:44 EDT Planet Fitness drops after West Virginia county asks clients to quarantine - Shares of Planet Fitness are lower after West Virginia's Monongalia County Health Department announced over the weekend that a client of the fitness center tested positive for COVID-19. Monongalia County is "urging members who were there during a window of time to quarantine and watch for symptoms." The agency said in a statement, "Anyone who was at Planet Fitness between 9 a.m. and 3 p.m. Wednesday, June 24 should stay at home for 14 days since being exposed, which would be until Wednesday, July 8. They also should watch for symptoms of COVID-19, which include shortness of breath, fever, dry cough, headache, nausea, vomiting, muscle aches and loss of smell." About 205 individuals were at Planet Fitness during that window of time, according to Monongalia County, who pointed out that West Virginia is seeing an increase in COVID-19 cases. Shares of Planet Fitness are down 3% to $59.94 in midday trading. Reference Link
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AEGN | Hot Stocks12:32 EDT Aegion awarded $6M wastewater rehabilitation contract in MA - Aegion announced that its subsidiary, Insituform Technologies, has been awarded a contract valued at $6m from the City of Newton, Massachusetts, for the rehabilitation of its wastewater systems. Aegion said in a release, "Insituform will perform a number of trenchless services on the project, including 70,000 linear feet of 6-inch to 12-inch cured-in-place pipe, or CIPP, lining, lateral lining, sectional liners and geopolymer manhole rehabilitation. Insituform has been installing CIPP lining for Newton since 2007 and has won more than $12 million in contracts since 2017. The project is recently underway and is expected to be fully completed by June 2021."
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KNOS | Hot Stocks12:31 EDT Kronos Advanced Technologie jumps after announcing pre orders for air filter - Kronos Advanced Technologies announced that the company is now taking pre-orders for its next-generation smart air disinfection active technology purifiers, Kronos Air 5G model, also marketed as AIRDOG X5 "This product line takes air purification to an entirely new level since it not only purifies by collecting and storing pollutants but in fact it kills the worst infectious viruses and bacteria with powerful output and speed, using intelligent laser air quality sensors and other innovative features. Utilizing the world's most advanced air purification combined with disinfection technology- our products terminate and collect more than 99.9% of infectious airborne viruses, bacteria, and mold inside your home or business. Earlier on Monday, Kronos Worldwide announced that The Kronos powerful multiple-speed fan automatically draws airborne pathogens through the electrostatic cold plasma disinfection and filtration 5-step process. Electrically charged ions generated within the device, trap, attract, zap and destroy mold, allergens bacteria, and infectious viruses. Unlike other passive air purification devices, it does this without the need to have an expensive replaceable filter. This air purifier/disinfection process produces clean safe air and incorporates a multi-stage high voltage electronic filtration method that uses eco-friendly washable carbon filters that virtually maintain 100% of the cleaning efficiency. Unlike HEPA, Kronos captures up to 14.6nm levels which is 20 times beyond HEPA. Conventional passive HEPA filters merely capture collect the worst which literally can then cause living microbial infestations to multiple since inside a HEPA it is dark, damp and warm which is the ideal condition to multiple germs and viruses, while Kronos destroys them in the collection process. This electronic filtration method not only attracts but annihilates bacteria and viruses via using high voltage electricity. The Model 5 captures 14.6nm/0.0146 Microns - smaller than one hundred millionth of a meter which is 20 times smaller than the best HEPA can collect. By eliminating the guesswork when to clean the electronic filter our smart technology reads out clean on its screen. Shares of Kronos Advanced Technologies are up almost 10% in midday trading to 85c per share.
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BLL LHX | Hot Stocks12:03 EDT Ball Aerospace selected for four NOAA operational weather studies - Ball Aerospace (BLL) was selected by the National Oceanic and Atmospheric Administration for four, six-month study contracts that will inform mission, spacecraft and instrument concepts for future operational weather architectures and Earth observation capabilities. Ball Aerospace is also collaborating on a fifth study contract awarded to L3Harris Technologies (LHX).
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TZA | Hot Stocks12:00 EDT Small Cap Bear 3x falls -9.0% - Small Cap Bear 3x is down -9.0%, or -$2.20 to $22.24.
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NOVA | Hot Stocks12:00 EDT Sunnova Energy falls -10.9% - Sunnova Energy is down -10.9%, or -$2.05 to $16.80.
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DGAZ | Hot Stocks12:00 EDT VelocityShares 3x Inv Natural Gas ETN falls -18.6% - VelocityShares 3x Inv Natural Gas ETN is down -18.6%, or -$100.55 to $440.00.
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LEAF | Hot Stocks12:00 EDT Leaf Group rises 18.8% - Leaf Group is up 18.8%, or 63c to $3.99.
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SHLL | Hot Stocks12:00 EDT Tortoise Acquisition rises 29.9% - Tortoise Acquisition is up 29.9%, or $7.35 to $31.92.
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UGAZ | Hot Stocks12:00 EDT VelocityShares 3x Long Natural Gas ETN rises 37.6% - VelocityShares 3x Long Natural Gas ETN is up 37.6%, or $2.70 to $9.89.
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RDHL | Hot Stocks11:51 EDT RedHill Biopharma receives approval for COVID-19 Phase 2/3 study with opaganib - RedHill Biopharma announced that the UK Medicines & Healthcare products Regulatory Agency has approved the Company's Clinical Trial Authorization application to commence a Phase 2/3 study evaluating opaganib in patients hospitalized with severe SARS-CoV-2 infection and pneumonia. RedHill has also submitted CTA applications for this study in Russia and Italy and plans to expand the study to additional countries. The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study is set to enroll up to 270 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects will be randomized at a 1:1 ratio to receive either opaganib or placebo, along with standard-of-care therapy. The primary endpoint of the study is to evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14. An unblinded futility only interim analysis will be conducted by an independent data safety monitoring board when approximately 100 subjects have been evaluated for the primary endpoint. The study is planned to be conducted in clinical sites across Italy, the UK, Russia and additional countries. In parallel, RedHill has initiated enrollment for a randomized, double-blind, placebo-controlled Phase 2a clinical study with opaganib in the U.S. This study is set to enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen. This clinical trial is not powered for statistical significance.
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SYNL | Hot Stocks11:30 EDT Privet, UPG urge Synalloy stockholders to vote for director nominees - Privet Fund Management and UPG Enterprises, which collectively own approximately 24.9% of the outstanding common stock of Synalloy Corporation, commented on Synalloy's rescindment of the limited duration stockholder rights plan unanimously authorized by its eight-member Board of Directors roughly three months ago. Privet and UPG have nominated independent candidates - Andee Harris, Chris Hutter, Aldo Mazzaferro, Ben Rosenzweig and John Schauerman - for election to the Company's Board at the 2020 Annual Meeting of Stockholders scheduled to be held on June 30, 2020. Ben Rosenzweig, Partner at Privet, and Chris Hutter, Co-Founder at UPG, commented: "Only three months after adopting a poison pill without stockholder approval, the Board is now trying to court favor with dissatisfied investors and win their votes by walking its decision back on the eve of the Annual Meeting. The Board's clandestine rescindment of Synalloy's poison pill over the weekend does not address the fact that the step was taken without stockholder approval in the first place. Moreover, conspicuously missing from Synalloy's announcement is a commitment from the Board that it will not just unilaterally put the pill back in place following the Annual Meeting should the incumbent directors retain control. This is why we are urging stockholders to avoid being misled by what amounts to a contradictory and disingenuous ploy. Stockholders should recognize that this latest maneuver, which was enacted by the Board as Synalloy's stock continues its descent toward a five-year low, only reinforces the need for meaningful change in the boardroom. The same entrenched directors who claimed they were implementing a poison pill because of the pandemic and Synalloy's purported trading price discount have now covertly rescinded it for entirely self-serving purposes. In light of this, we question how stockholders can believe that a Board dominated by the incumbents is best situated to save Synalloy. After failing to produce a strategic plan with tangible targets and projected goals over the course of this election contest, the incumbents have demonstrated once and for all that their priority is self-preservation over stockholder value creation."
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DKNG | Hot Stocks11:21 EDT Stats Perform announces multi-year extension with DraftKings - Stats Perform announced a multi-year extension with DraftKings. The deal provides DraftKings access to Stats Perform's sports data feeds for use in its daily fantasy sports contests and DK Live, the company's play-by-play fantasy app. Through the partnership extension, DraftKings will incorporate Stats Perform data from a multitude of professional sports leagues, including the NBA, MLB, NHL, WNBA, FIBA, CFL, college football, men's college basketball and most top soccer leagues worldwide. The increase in data accessibility will allow DraftKings to further expand its daily fantasy contests across different sports and countries.
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CNI | Hot Stocks11:17 EDT Canadian National investing C$445M in British Columbia - CN announced that, as part of its strategic investments to support growing demand and enable supply chains, it plans to invest approximately C$445 million across British Columbia in 2020. CN said in a release, "The investments will include expansion projects that will add track in yards to handle growing traffic, new sidings as well as continued investments in multi-year initiatives to increase capacity at the Port of Vancouver and at the Port of Prince Rupert in collaboration with the Government of Canada, the Vancouver Fraser Port Authority, and the Prince Rupert Port Authority. The maintenance program will focus on the replacement of rail and ties and maintenance work on level crossings, culverts, signal systems and other track infrastructure. The Company's investments will create greater capacity, which supports reductions in its customer's transportation supply chain GHG emissions, by encouraging the use of rail for long haul needs. This reduces emissions, traffic congestion, accidents and burdens on public transportation infrastructure as one freight train can replace over 300 trucks from roads. Moving freight by rail instead of truck reduces GHG emissions by 75%. The Company will continue to deploy important safety enhancing technologies across its network, such as the Autonomous Track Inspection Program, Distributed Air Cars and Automated Inspection Portals."
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WINR | Hot Stocks11:12 EDT Simplicity Esports acquires PL Gaming Texas, terms not disclosed - plicity Esports and Gaming Company announced that it formed a new, majority owned subsidiary and acquired all of the assets of PL Gaming Texas, franchisee-owned esports gaming centers. The consideration paid for the acquisition was a combination of cash and restricted shares of common stock. Additionally, Simplicity Esports executed a lease assignment and amendment with the landlord that does not require a specified fixed rent, but instead determines rent as a percentage of gross sales.
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DVAX... | Hot Stocks11:10 EDT Dynavax, Moderna, Novavax COVID-19 vaccine candidates listed in WHO review - The World Health Organization released landscape documents that it has prepared "for information purposes only concerning the 2019-2020 global of the novel coronavirus." WHO stated that inclusion of any particular product or entity in any of its landscape documents "does not constitute, and shall not be deemed or construed as, any approval or endorsement by WHO of such product or entity." Among the 17 candidate vaccines in clinical evaluation, WHO listed products under development from or in partnership with AstraZeneca (AZN), Moderna (MRNA), Sinopharm Group (SHTDF), Novavax (NVAX), BioNTech (BNTX) and Pfizer (PFE), Inovio (INO), GlaxoSmithKline (GSK) and Dynavax (DVAX), and others. Reference Link
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AMZN | Hot Stocks10:46 EDT Amazon to pay one-time bonuses of $500 to logistics workers - Dave Clark, SVP WW Operations, sent a note to Amazon's front-line employees and partners-those who have been preparing orders in one of our fulfillment centers, delivering orders to customers' homes, helping customers in a store, or one of the many roles in between. "Our front-line operations teams have been on an incredible journey over the last few months, and we want to show our appreciation with a special one-time Thank You bonus totaling over $500 million. All front-line employees and partners who were with the company throughout the month of June [June 1 - June 30, 2020], will receive a bonus of: 500 for full-time Amazon employees, Whole Foods Market employees, and Delivery Service Partner drivers; $250 for part-time Amazon employees, Whole Foods Market employees, and Delivery Service Partner drivers; $1,000 for all front-line Amazon and Whole Foods Market leaders; $3,000 for our Delivery Service Partner owners; $150 for each Amazon Flex driver with more than 10 hours in June. Again, my thanks and gratitude for the truly remarkable commitment to customers you have shown throughout this journey. I have never been more proud of our teams." Reference Link
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DNK | Hot Stocks10:00 EDT Phoenix Tree rises 9.8% - Phoenix Tree is up 9.8%, or 90c to $10.11.
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SHLL | Hot Stocks10:00 EDT Tortoise Acquisition rises 19.0% - Tortoise Acquisition is up 19.0%, or $4.68 to $29.25.
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UGAZ | Hot Stocks10:00 EDT VelocityShares 3x Long Natural Gas ETN rises 27.8% - VelocityShares 3x Long Natural Gas ETN is up 27.8%, or $2.00 to $9.19.
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ACST | Hot Stocks09:59 EDT Acasti Pharma says 'substantial doubt' on ability to continue as going concern - Cash and cash equivalents and short-term investments totaled $14.2M as of March 31, 2020, compared to $25.8M for the year ended March 31, 2019. Acasti believes that existing cash will fully fund the Company's operations into the first calendar quarter of 2021. Acasti projects that additional funds will be needed in the future for activities necessary to prepare for the commercial launch of CaPre if regulatory approval is received, including the scale-up of its manufacturing operations, the completion of the potential regulatory NDA submission package, and the expansion of business development and U.S. commercial launch activities. The Company is working towards development of strategic partner relationships, as well as actively seeking additional non-dilutive funds in the near future, but there can be no assurance as to when or whether Acasti will complete any strategic collaborations or non-dilutive financings. If the Company does not raise additional funds or find one or more strategic partners, it may not be able to realize its assets and discharge its liabilities in the normal course of business. As a result, there exists substantial doubt about the Company's ability to continue as a going concern, and therefore, realize its assets and discharge its liabilities in the normal course of business.
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ACST | Hot Stocks09:56 EDT Acasti Pharma expects TRILOGY 2 topline results in Q3
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ACST | Hot Stocks09:55 EDT Acasti Pharma sees cash sufficient into 1Q21 - As of March 31, 2020, Acasti had cash, cash equivalents and short-term investments totaling $14.2M, compared to $25.8M as of March 31, 2019. The Company believes it is sufficiently funded into the first calendar quarter of 2021, based on management's current projections.
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ACST | Hot Stocks09:54 EDT Acasti identifes 'Triglyceride Normalization' phenomenon in TRILOGY study - Acasti Pharma provided a business and TRILOGY Phase 3 Clinical Program update, and announced its operating and financial results for the fiscal year ended March 31, 2020. The Company also reported a phenomenon that it refers to as "Pre-Randomization Triglyceride Normalization" that occurred between the screening and randomization periods of the study, and prior to patients starting on drug or placebo. The Company released topline results from its TRILOGY 1 Phase 3 trial in January 2020, reporting a 30.5% median reduction in triglyceride levels among patients receiving CaPre at 12 weeks, and a 42.2% median reduction in triglyceride levels among patients receiving CaPre while on background statin therapy at 12 weeks. Additionally, the Company reported a 36.7% median reduction in triglyceride levels among patients receiving CaPre at 26 weeks. Despite positive results in the CaPre arm, TRILOGY 1 did not reach statistical significance due to an unusually large placebo response of 27.5% and 28.0% median reductions in triglyceride levels at 12 and 26 weeks, respectively. The safety profile of CaPre in TRILOGY 1 was similar to placebo, as there was no significant difference in treatment-related serious adverse events in the trial. The protocol for TRILOGY 1 and 2 had input from and was approved by the FDA, and followed essentially the same standard design as has been used by all other companies running trials in sHTG. There were some slight differences in the TRILOGY 1 patient population as compared to previous studies with other omega-3 therapeutics in sHTG, but none that were believed to have contributed to the significant placebo effect. As previously reported, despite monitoring activities conducted throughout the TRILOGY 1 trial to ensure adherence to the protocol and to detect potential protocol violations, Acasti subsequently identified some unexpected and inconsistent findings that the Company believes may have negatively contributed to the unusual placebo effect. These findings were further explored via a comprehensive and rigorous post-hoc review of the data by the Company, the academic Principal Investigator of the study, Dariush Mozaffarian M.D., Dr.P.H., and external clinical and statistical experts, as well as audits of the central blood testing laboratory and certain clinical sites, which were conducted by an independent team of auditors. This post-hoc analysis of the TRILOGY 1 data revealed a rapid, significant and sustained reduction in TG levels during the patient qualification period, which took place between screening and the time of patient randomization. Acasti refers to this phenomenon as "Pre-Randomization TG Normalization." This phenomenon, which to our knowledge has not been reported in any other TG studies, resulted in an artefactual overestimation of TG reduction in both treatment groups. However, the Pre-Randomization TG Normalization was much greater in the placebo group as compared to the CaPre group, resulting in a significant underestimation of the post-randomization treatment effect of CaPre in TRILOGY 1, and further compromising the ability of the study to detect a clinically significant drug treatment effect. TG values are normally quite variable, and it is expected that the intra-individual TG variation in subjects on a healthy, low fat National Cholesterol Education Program diet may be 10% or greater within a one to two week period. Thus, it is standard practice to include 2 or 3 pre-randomization TG measurements in the determination of the baseline for the calculation of the primary endpoint. The pre-randomization reduction in TGs across all subjects in TRILOGY 1 was about 20%, with 25% of all subjects experiencing a reduction equal to or greater than 38%. The median Pre-Randomization TG Normalization reached 30% or more in 12 out of 54 sites, in all, much greater than the 10% variation that would have been expected based on physiological variability. In addition, natural variability would have resulted in both increases and decreases in individual levels which would largely offset each other, limiting aggregate variability below 10%. The magnitude of pre-randomization reduction in TG levels seen in TRILOGY 1 indicated a largely unidirectional variability, which was not likely due solely to physiological intra-individual variation, and therefore is considered to be artefactual. The unexpected and large magnitude of this Pre-Randomization TG Normalization phenomenon resulted in about 40% of all randomized and eligible subjects having TG levels at randomization that fell below the protocol specified average qualification lower threshold of greater than or equal to 500 mg/dL for patients with sHTG. Based on the above observations, we believe that the Pre-Randomization TG Normalization substantially impacted the outcome of TRILOGY 1, and the ability of the study to accurately determine the therapeutic impact of CaPre as measured by the pre-specified primary endpoint. Specifically, we believe that the use of an average of 3 values for the calculation of the baseline TG levels corresponding to time points during Qualification, and Week 0, resulted in an overestimation of the TG reduction, particularly in the placebo group - with significant TG reduction occurring in many patients even before either drug or placebo were started. The Company conducted post-hoc analyses of the primary endpoint using a revised, single point baseline value from Week 0, the date of randomization, which is referred to as the "Revised Baseline." Furthermore, only those subjects meeting the protocol-specified TG threshold of greater than or equal to 500 mg/dL and less than or equal to 1500 mg/dL at Week 0 were included in this post-hoc analyses. This revised approach for calculating the baseline TG levels corrected for a significant amount of the pre-randomization TG reduction in the subjects that were most affected by this normalization phenomenon. After patients with TG values less than500 mg/dL and greater than1500 mg/dL on the date of randomization were removed, a total of 143 subjects remained, including 42 subjects in the placebo group, and 101 subjects remained in the CaPre group, and were included in the post-hoc analyses representing 61% and 58% of all randomized subjects, respectively. In this post-hoc analysis of subjects with TG levels meeting the protocol specified TG threshold of greater than500 mg/dL and less than1500mg/dL at Week 0, subjects receiving CaPre showed a 28.1% median reduction in TG compared to a 15.4% median reduction among subjects receiving placebo after 12 weeks. As compared to the original analysis, the Revised Baseline attenuated the placebo response by approximately 12 percentage points, while the response in the CaPre arm remained mostly unaffected. After 26 weeks of double-blind treatment, the efficacy of CaPre showed good persistency of effect with a 32.6% median reduction compared with a 14.6% median reduction in the placebo group, reaching a non-adjusted difference of -18.0%, which trended toward statistical significance. As compared to the original analysis, the Revised Baseline attenuated the placebo response at 26 weeks by approximately 13 percentage points, while the response in the CaPre arm remained mostly unaffected. The median TG reductions seen with CaPre using this post-hoc methodology compare favorably to those of previous published studies of other FDA approved drugs for sHTG. The subgroup of subjects with Revised Baseline TG levels above 750 mg/dL at Visit represented 41% of the subjects retained in the post-hoc analyses. Within this group, the median TG reduction in the subjects receiving CaPre was larger as would be expected, reaching 36.3% and 43.0% at Week 12 and Week 26, respectively. In comparison, the median TG reduction for the placebo group was 11.8% at Week 12 and 14.4% at Week 26, resulting in non-adjusted differences of 24.5% and 28.6% respectively in favor of CaPre. Not surprisingly, a post-hoc power calculation revealed that these substantially smaller sample sizes resulted in reduced statistical power to detect a treatment difference of 20% as specified in the original Statistical Analysis Plan. However, the Company believes that these post-hoc results suggest clinical relevance even if statistical significance was not demonstrated, as it is plausible that the trend revealed in the post-hoc analysis may have achieved statistical significance with a larger sample size. In summary, the post-hoc analyses of TRILOGY 1 data using the Week 0 calue as a Revised Baseline in subjects with TG greater than or equal to 500 mg/dL and less than or equal to 1500 mg/dL at Week 0, showed a strong trend towards correcting for the unexpectedly large placebo response observed in the original analysis, without major changes in the CaPre response observed, and we believe allows for a clearer understanding of the impact on the TG primary endpoint, and the potential therapeutic effect of CaPre. However, the median difference in TG levels between CaPre and placebo from the TRILOGY 1 post-hoc analyses still fell short of reaching statistical significance at the Week 12 primary endpoint in this patient adjusted sample The Company provided all of the TRILOGY 1 background information and accompanying data to the FDA in a Type C briefing package which was filed on April 29, 2020. The FDA provided Acasti with a written response to its Type C Meeting request and briefing package, and confirmed that it will require pivotal efficacy analyses for TRILOGY 2 to be performed on the full Intent to Treat population, as contemplated in the original Statistical Analysis Plan, and they supported the conduct of post-hoc analyses in TRILOGY 1 for exploratory purposes. Consistent with the Company's prior disclosures, and depending on the outcome of TRILOGY 2, an additional clinical study may still be needed prior to submitting a New Drug Application. Acasti and its expert advisors are now carefully considering the FDA's comments on the TRILOGY 1 data and will conduct further post-hoc analysis based on their feedback.
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ARL | Hot Stocks09:47 EDT American Realty Investors falls -6.6% - American Realty Investors is down -6.6%, or -62c to $8.78.
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AMC | Hot Stocks09:47 EDT AMC Entertainment falls -8.7% - AMC Entertainment is down -8.7%, or -36c to $3.81.
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DGAZ | Hot Stocks09:47 EDT VelocityShares 3x Inv Natural Gas ETN falls -13.1% - VelocityShares 3x Inv Natural Gas ETN is down -13.1%, or -$70.55 to $470.00.
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COTY | Hot Stocks09:47 EDT Coty rises 13.6% - Coty is up 13.6%, or 57c to $4.75.
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SHLL | Hot Stocks09:47 EDT Tortoise Acquisition rises 19.1% - Tortoise Acquisition is up 19.1%, or $4.71 to $29.27.
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UGAZ | Hot Stocks09:47 EDT VelocityShares 3x Long Natural Gas ETN rises 23.1% - VelocityShares 3x Long Natural Gas ETN is up 23.1%, or $1.66 to $8.85.
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VERO | Hot Stocks09:41 EDT Venus Concept receives 510(k) premarket notification for Venus Viva MD Device - In a decision dated June 26, the FDA judged the Venus Viva MD Device submitted by Venus Concept USA as "Substantially Equivalent," a post to the FDA website indicates. Reference Link
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RTIX | Hot Stocks09:39 EDT RTI receives 510(k) premarket notification for Streamline Navigated Instruments - In a decision dated June 26, the FDA judged the Streamline Navigated Instruments submitted by Pioneer Surgical Technology, Inc. DBA RTI Surgical, as "Substantially Equivalent," a post to the FDA website indicates. Reference Link
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T | Hot Stocks09:33 EDT AT&T announces 5G launch in 28 new markets, including Miami, Dallas - AT&T's 5G network is now live for consumers in 28 additional markets across the country and covers more than 160 million people. With today's launch, AT&T now offers access to 5G in a total of 355 markets in the U.S. "DSS is an important steppingstone on our path to nationwide 5G," said Igal Elbaz, SVP of wireless and access technology. "We were the first U.S. carrier to deploy this technology in our network, and it's now playing an important role as we work toward a nationwide 5G footprint this summer."
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IDEX | Hot Stocks09:33 EDT Ideanomics responds to J Capital and Hindenburg short-selling report - Ideanomics announced a response to the recent short-selling communications from J Capital and Hindenburg. The company said, "According to their websites, these companies take short positions in publicly traded companies then disseminate very negative reports on these companies." "After consultation with our legal counsel, we believe these communications, marketed as research are illegal or have been banned in many countries, but continue to operate in the grey areas of financial regulatory law in the United States," said Alf Poor, CEO of Ideanomics. Ideanomics response said, "J Capital alleged that Ideanomics does not have sufficient cash to fund operations for more than three months. This statement can easily be reconciled from the Company's recent series of filings of form 424B2 with the SEC, which clearly shows the company has raised capital in recent weeks and months.Hindenburg Research alleged that Ideanomics claims to own and operate a large-scale facility in Qingdao for its MEG division sales and that their investigators have been on-site and claim MEG does not have a presence there. Ideanomics has never claimed or disclosed ownership of the site. It holds a 15-year rent-free agreement which was signed by Ideanomics in Nov. 2019 and has since provided images to show its participation at the site. Hindenburg Research disseminated social media content regarding their conversation with MEG partner's sales staff with auto dealers at this site. We have since obtained statements from these staff members that refute Hindenburg's claims. J Capital has alleged it made inquiries with the local Qingdao city investment group for the Chengyang business district - Qingdao Chengyang Xinyang Investment Co. Ltd - and that they have no knowledge of Ideanomics or its MEG division. Ideanomics is providing government-issued registration of the venture with our Company, which is a matter of public record in China. Furthermore, the city investment entity has released details of its interest in the ventures, including a recent RMB 50 Million investment received by the Company in January 2020, as part of a potential series of investments, and recent media coverage in the People's Republic of China corroborates this. J Capital further alleges that it has inquired with recent deals signed by Ideanomics MEG division, and its subsidiaries, and that these companies deny having a business relationship with our Company. We have contacted each of the partners and they have provided statements confirming their business relationships with our Company, and have each applied their respective company seal for authenticity, in order to refute those claims entirely. These partners include Tianjin Zhongcheng order for 42 units of Toyota Land Cruiser, Jiudao Group for 400 units of Aoxin X30L EV, Beijing Silk Road Rainbow, and Qinou Group order of 200 units of Dong Feng Liuzhou S50EV for the City of Neijiang, Sichuan."
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CEQP CHK | Hot Stocks09:32 EDT Crestwood Equity responds to Chesapeake bankruptcy filing - Crestwood Equity Partners (CEQP) announced that Chesapeake Energy (CHK), a customer in the Powder River Basin and northeast Marcellus, has filed for protection under Chapter 11 of the U.S. bankruptcy code. Crestwood said in a release, "Crestwood has been preparing for this event over the past few months and is well-positioned to maintain full operations to Chesapeake throughout bankruptcy proceedings. Crestwood's gathering and processing systems are integral to Chesapeake's operations in the Powder River Basin, as a substantial amount of its revenues are derived from the sale of natural gas and natural gas liquids, or NGLs, produced from acreage dedicated to Crestwood, which is the most economic path to market. Chesapeake is current on all outstanding invoices payable to Crestwood and additional cash flow protection is in place via letters of credit. In the Powder River Basin, Crestwood's midstream assets are supported by a 358,000 acreage dedication by Chesapeake and a 30,000 acreage dedication by Panther Energy, as well as dedications by other producers in the basin. The Bucking Horse processing facility and the Jackalope gas gathering system are supported by a 20-year fixed fee gathering and processing agreement with Chesapeake that was restructured in the first quarter 2017 and reflects competitive market terms in-line with other midstream operators in the basin. Crestwood provides a critical service to Chesapeake with over 320 wells connected to the Jackalope system. Following today's announcement, Crestwood does not anticipate any changes to its ability to achieve the revised 2020 cash flow forecast and financial metrics provided on May 5."
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AVCO | Hot Stocks09:32 EDT Avalon GloboCare completes Phase 1 study of AVA-001 - Avalon GloboCare announced it has completed Phase I first-in-human clinical study of its leading Chimeric Antigen Receptor T-cell therapy candidate, AVA-001. Nine out of ten patients with relapsed/refractory B-cell acute lymphoblastic leukemia have achieved complete remission within one month after the initiation of AVA-001 CAR T-cell therapy treatment. The treatment with AVA-001 was generally well tolerated with minimal toxicities and adverse side effects. No neurotoxicity or greater than Grade-1 cytokine release syndrome was observed in this cohort of patients treated with AVA-001. All patients who achieved CR successfully proceeded to allogeneic bone marrow transplant with curative intent. AVA-001 is a third generation CAR T-cell therapy which involves the 4-1BB co-stimulation signaling pathway. Accessary laboratory testing that accompanied this pilot clinical study has demonstrated evidence of enhancement in CAR T cell persistence and protection against CAR T cell exhaustion. Avalon will present the results of this AVA-001 Phase 1 clinical trial on July 11,2020 at The Eighth Annual Lu Daopei Hematology Forum, the largest Hematology Conference in Asia.
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SNPS | Hot Stocks09:30 EDT Synopsys signs multi-year agreement with Arm to accelerate SoCs - Synopsys announced it has signed a multi-year agreement with Arm for the purpose of accelerating design and verification of Arm-based system-on-chips, or SoCs, for mutual customers. With this agreement, Synopsys and Arm will jointly develop and distribute optimized Synopsys product reference methodologies to Arm customers and deliver training on the use of Synopsys products and flows with Arm IP. Under the agreement, Synopsys receives early access to Arm Cortex and Arm Neoverse processors, Arm Mali GPUs, Arm CoreLink system IP, Arm Artisan physical IP, Arm Mali image signal processors and Arm POP IP.
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WRTC | Hot Stocks09:29 EDT Wrap Technologies receives international order for 21,600 BolaWrap cartridges - Wrap Technologies announced the Company has received a new follow-on order for 21,600 additional BolaWrap cartridges for the Indonesia National Police force. Wrap Technologies said in a release, "Earlier this month, the Company reported the fulfillment of an initial order of devices and cartridges placed by the Company's distributor in Indonesia at the end of 2019. The Company's distributor recently secured a contract with the Indonesian National Police force following successful BolaWrap demonstrations across the country. The Company supplied the Indonesian National Police force with BolaWrap devices customized with the police force's logo and matching uniform colors. The Indonesian National Police force consists of approximately 387,000 police officers, and they plan to use this new order of cartridges with previously purchased BolaWrap devices to begin training thousands of officers in their agency. The Company expects to recognize revenue on this order in Q2 and Q3 of 2020."
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CBAT | Hot Stocks09:28 EDT CBAK Energy subsidiary enters framework investment agreement with Gaochun EDZ - CBAK Energy announced that its wholly owned subsidiary, China BAK Asia Holdings entered into a framework investment agreement with Jiangsu Gaochun Economic Development Zone, or EDZ, pursuant to which the company intends to develop certain lithium battery projects that aim to have a production capacity of 8Gwh. Meanwhile, Gaochun EDZ agreed to provide various support to, including but not limited to subsidies, preferential financing support and tax incentives, to facilitate the development and operation of the projects.
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CMTL | Hot Stocks09:27 EDT Comtech receives $1.8M delivery order to support U.S. Air Force - Comtech Telecommunications announced that during its fourth quarter of fiscal 2020, its Tempe, Arizona-based subsidiary, Comtech EF Data, which is part of Comtech's Commercial Solutions segment, received a delivery order in support of a recently awarded contract for engineering services from a large prime U.S. Department of Defense contractor. Comtech said in a release, "This latest delivery order is for $1.8 million to support a critical Air Force and Army Anti-jam Modem, or A3M, program under the U.S. Space Force's Space and Missile Systems Center. The $4.7 million contract has been funded $2.3 million to date. The A3M program will provide the Air Force and Army with a secure, wideband, anti-jam satellite communications terminal modem for tactical satellite communication operations. The jam-resistant modems will support SMC's Protected Tactical Waveform technology, an anti-jam capability operating on military satellite communication terminals through the Wideband Global Satcom constellation."
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D | Hot Stocks09:25 EDT Dominion announces installation of two turbine, 12-megawatt CVOW pilot project - Dominion announced the installation of the two turbine, 12-megawatt Coastal Virginia Offshore Wind, or CVOW, pilot project 27 miles off Virginia Beach. The first offshore wind farm to be approved by the Bureau of Ocean Energy Management, or BOEM, and installed in federal waters, and second constructed in the United States, was built safely and on schedule despite the worldwide impact from the coronavirus pandemic. The turbines will now undergo acceptance testing before being energized later this summer and producing enough clean, renewable energy, at peak output, to power 3,000 Virginia homes. Dominion Energy will apply the permitting, design, installation and operations experience from the pilot project to its proposed 2,600-megawatt commercial project. That project, which is the largest announced offshore wind project in North America, is on track to commence construction in 2024, and upon completion, will provide enough renewable electricity to power up to 650,000 homes.
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MYSZ | Hot Stocks09:22 EDT MySize announces Sweet Fit integrates MySizeID into platform - MySize announced that Sweet Fit, an interactive virtual fitting mirror, has integrated MySizeID into its technology platform. Sweet Fit is a virtual fitting mirror that uses augmented reality technology to scan a person's figure and display a virtual outfit. With the integration of MySizeID, shoppers can select the appropriate apparel size for a specific brand, based on real-time body measurements. Sweet Fit is currently available in France, with plans to expand internationally.
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NDAQ | Hot Stocks09:21 EDT Nasdaq announces board of directors of U.S. Exchanges - Nasdaq announced the election of all nominated directors to the boards of the U.S. exchanges operated by the company, which include The Nasdaq Stock Market LLC, Nasdaq PHLX LLC, Nasdaq BX, Inc., Nasdaq ISE, LLC, Nasdaq MRX, LLC, and Nasdaq GEMX, LLC: Tal Cohen, EVP and Head of North American Markets, Nasdaq; Virgis W. Colbert, Retired EVP, Miller Brewing Co., Senior Advisor, MolsonCoors; Michael Curran, Retired Chairman and CEO, Boston Stock Exchange; David Frear, Senior EVP and CFO, SiriusXM Holdings; Thomas Kloet, Retired CEO and Executive Director, TMX Group Limited; Elizabeth Martin, Global Co-Head of GS Electronic Trading and Futures, and EMEA Execution Services and Equities Systematic Market Making, Goldman Sachs; David Rosato, Senior EVP and CFO, People's United Financial; Andrew Schultz, Head of Strategic Options, Susquehanna International Group; Wendy White, SVP and General Counsel, University of Pennsylvania and Penn Medicine.
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TFFP | Hot Stocks09:20 EDT TFF announces first human dosing with Tacrolimus Inhalation Powder - TFF Pharmaceuticals announced the initiation of its second clinical trial program with the dosing of healthy subjects with Tacrolimus Inhalation Powder. TFF said in a release, "This Phase 1 single ascending dose, or SAD, and multiple ascending dose, or MAD, study will assess the safety, tolerability and pharmacokinetics of tacrolimus, an important immunosuppressive agent for the prophylactic treatment of lung transplant rejection. Subjects were dosed at a single site in Australia under the Australian CTN process. The Company also announced topline safety data from the single ascending dose portion of its Phase 1 clinical trial of Voriconazole Inhalation Powder, a next-generation, direct-to-lung, inhaled dry powder version of Voriconazole. Voriconazole is generally considered to be the most effective antifungal drug for treating Invasive Pulmonary Aspergillosis."
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TNDM ABT | Hot Stocks09:20 EDT Abbott, Tandem Diabetes to develop integrated diabetes solutions - Abbott (ABT) and Tandem Diabetes (TNDM) announced that they have finalized an agreement to develop and commercialize integrated diabetes solutions that combine Abbott's continuous glucose monitoring, or CGM, technology with Tandem's insulin delivery systems to provide more options for people to manage their diabetes. The companies first announced their intention to work together in October 2019, and this resulting agreement covers the technical development of device integration and associated commercial support activities. The companies will partner to integrate Abbott's FreeStyle Libre continuous glucose monitoring technology with Tandem's insulin delivery products to provide options for diabetes management.
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CIDM | Hot Stocks09:19 EDT Cinedigm announces MyTime Movie Network debut in Fall - Cinedigm announced the launch of the all-new female-focused streaming linear channel MyTime Movie Network, to debut in early Fall 2020. MyTime Movie Network is the latest addition to Cinedigm's growing portfolio of digital-first linear networks, which currently includes popular networks including The Bob Ross Channel, fandom network CONtv, family entertainment network Dove Channel, and the documentary-focused Docurama, among many others.
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MATW | Hot Stocks09:19 EDT Matthews announces sale of investment in pet cremation business - Matthews International announced the sale, on June 26, 2020, of its noncontrolling ownership interest in a pet cremation services business. The Company sold its ownership interest for a sales price of $57.2M, consisting of $42.2M cash and $15.0 million preferred stock. Matthews International intends to apply the cash proceeds from the sale to debt repayment.
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NWVCF | Hot Stocks09:17 EDT EnWave signs equipment purchase agreement with Calbee - EnWave announced that it has signed an Equipment Purchase Agreement with Calbee to commission an additional two 10kW Radiant Energy Vacuum dehydration machines in Japan. The addition of the two 10kW REV machines will significantly expand Calbee's commercial manufacturing capacity to launch its new line of REV-based snack products. Calbee has successfully developed several "better-for-you" snack products internally using REV technology and intends to intensify its commercial efforts throughout 2020, focusing on premium, healthy fruit and vegetable snack products. Calbee entered into a royalty-bearing commercial license agreement with EnWave approximately one year ago, and the purchase of the two additional REV machines demonstrates the commercial value of using EnWave's proprietary technology for producing premium snack products. albee continues to have the exclusive rights to commercialize EnWave's REV food dehydration technology for the development of several premium, healthy fruit and vegetable snack products and ingredients in the country of Japan. The installation of the two additional 10kW machines will triple the royalty-bearing production capacity of Calbee in Japan.
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MDB | Hot Stocks09:17 EDT MongoDB appoints Mark Porter as CTO - MongoDB announced the appointment of Mark Porter as CTO, effective July 20. Porter will oversee the office of the CTO and play a role in driving the company's technology vision. With this appointment, Porter will step down from MongoDB's board. Porter joins MongoDB from Grab, Southeast Asia's app that provides services such as ride-hailing, food, package, grocery delivery, mobile payments and financial services to millions of people. At Grab, Porter was CTO, core technology and transport, and he led teams across Grab's eight R&D centers in Asia, America and Europe.
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BRQS | Hot Stocks09:16 EDT Borqs Technologies ruggedized mobile phones certified by mobile operators - Borqs Technologies announced that the intrinsically safe mobile rugged phones which it developed for its German technology partner has passed the stringent certification of two of the largest mobile operators in North America. Borqs has started to deliver products ordered by the German technology partner and is ramping up production rapidly. In April this year, Borqs has announced that it has formed a partnership with a leading German partner for its Intrinsically Safe Mobile Devices and has supplied key technologies which enable the German partner to deliver rugged enterprise-class mobile products that can be used in hazardous areas, with high levels of expertise and reliability in demanding projects in the field of explosion-shielded products. As a partner to customers from the most diverse sectors, which include the chemical, petrochemical, pharmaceutical and mining industries, Borqs' technologies are used in the German partner's market-winning Android smartphones. One of these phones is the world's first intrinsically safe smartphone for Zone 1/21 and Div. 1 areas that meets Google's sophisticated Android Enterprise Recommended validation. The devices together with the accessories provide a wide range of safe and reliable mobile instruments for measuring and calibrating inside and outside hazardous parameters, ranging from the multimeter to devices for measuring temperature, pressure and rpm, plus pressure, current loop and process calibrators, etc. These orders will be filled in the second half of 2020 and also into 2021.
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STZ | Hot Stocks09:14 EDT Constellation Brands announces comprehensive effort in advancing social justice - Constellation Brands announced its commitment to a multi-initiative social justice action plan aimed to achieve greater equity for African American/Black colleagues at Constellation, within the beverage alcohol industry, and within the communities they operate in. Constellation Brands Ventures, the company's corporate venture capital group, will invest $100 million in African American/Black and minority-owned businesses in the beverage alcohol space and adjacent categories by 2030 through a new program, Focus on Minority Founders. Data has shown that the venture capital ecosystem is starkly homogeneous. In a study of U.S. venture activity from 2013 through 2017, just 1% of VC-backed entrepreneurs were Black. In addition to funding, the Focus on Minority Founders initiative will support the growth and development of Black and minority-owned businesses by providing sales, marketing, operations, and finance expertise through the CBV team and Constellation's many subject matter experts. In support of societal reform, Constellation is entering a multi-year partnership with the Equal Justice Initiative. The partnership will include a contribution of $1M to further EJI's mission and provide training opportunities for Constellation leadership. Founded by Bryan Stevenson in 1989, EJI is committed to challenging racial and economic injustice, advocating for equal treatment in the criminal justice system, and protecting basic human rights for the most vulnerable in American society. Also part of its action plan, Constellation is taking steps internally and within its extended network of business partners to create greater equity for African American/Black colleagues. The company is reviewing recruitment, hiring, and talent development practices to ensure African American/Black talent is supported and unconscious bias is addressed at all levels. The company is also evaluating brand engagements and advertising policies to ensure media partners, brand sponsorships, and other activations are aligned to brand and company values. For example, true to its brand ethos of supporting and empowering all women, Kim Crawford has partnered with Black Girl Ventures, a non-profit providing greater access to funding and resources for Black and Brown female entrepreneurs and a stronger pathway for women of color to launch and grow their own business.
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CONE | Hot Stocks09:11 EDT CyrusOne appoints Bruce Duncan as CEO - CyrusOne announced that CyrusOne's board has elected Bruce Duncan as President & CEO and as a member of the board, effective July 6. CyrusOne said in a release, "Duncan succeeds Tesh Durvasula, who has served as CyrusOne's interim President & CEO since February 20. Durvasula will work with Duncan to ensure a smooth leadership transition."
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GOVX | Hot Stocks09:10 EDT GeoVax Labs announces closing of $1M private placement - GeoVax Labs announced the closing, on June 26, 2020, of a private placement offering whereby the Company entered into a securities purchase agreement with an institutional investor. Pursuant to the Purchase Agreement, the Company issued the Investor convertible senior secured debentures in the aggregate principal amount of $1,200,000 and Warrants to purchase an aggregate of 2,400,000 shares of the Company's common stock. The Debentures accrue interest at a rate of 5% per annum and are initially convertible into shares of the Company's common stock at a conversion price of $0.50 per share, subject to adjustment. The Debentures mature one year from the date of issuance, are secured by substantially all of the Company's assets, and contain customary events of default. The Debentures are mandatorily convertible into common stock upon the Company's consummation of a public offering with gross proceeds of $6 million or more at the lower of the conversion price or 80% of the offering price for the offering. Further details are contained in the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on June 26, 2020. Pursuant to the Purchase Agreement, the Investor also received Warrants to purchase shares of the Company's common stock equal to the number of shares of common stock initially issuable upon conversion of its Debenture as of the date of issuance. The Warrants are exercisable for a period of five years from the date of issuance at a price of $0.50 per share, subject to adjustment.
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HRTX | Hot Stocks09:10 EDT Heron Therapeutics trading resumes
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FAT | Hot Stocks09:09 EDT Fatburger, Buffalo's Express debuts in Alaska - FAT Brands announces the opening of a co-branded Fatburger and Buffalo's Express in Fairbanks, AK. The grand opening of the restaurant, the first to open in Alaska, will be open, Monday, June 29, 2020.
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IMAX | Hot Stocks09:08 EDT Imax, CGV to launch 117 new theaters internationally - Imax and CGV announced an expansion of their partnership with an agreement to launch 17 new theaters around the world. The agreement includes nine new Imax theaters in South Korea as well as theaters across CGV's global footprint, which includes Turkey, Vietnam and Indonesia. The agreement is the biggest theatre deal for IMAX in 2020 to date. As a result of their 15-year partnership, CGV and IMAX now have more than 185 open or contracted theaters worldwide.
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INVE | Hot Stocks09:08 EDT Identiv announces strategic partnership with CertiPath - Identiv announced a strategic partnership with CertiPath. The two companies are teaming up to launch TrustVisitor, a Federal Identity, Credential, and Access Management, pre-screening enterprise visitor management platform integrated with Hirsch Velocity Software. TrustVisitor, the first of its kind to manage the complete life cycle of a visit, is designed for federal, energy, banking, healthcare and defense customers utilizing high-assurance credentials for physical access. Visitor management is a key component of a complete FICAM-compliant platform. Hirsch Velocity Software-based TrustVisitor enables federal agencies to utilize PIV, PIV I, CAC, and high-assurance CIV and government ID credentials as sanctioned by Homeland Security Presidential Directive 12. The platform establishes pre-visit questions that reinforce the most up-to-date Centers for Disease Control and Prevention and Department of Homeland Security requirements for COVID-19, whereby agencies and clients determine whether visitors are permitted to enter their buildings.
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PLBC | Hot Stocks09:07 EDT Plumas Bancorp to join Russell 2000 index - Plumas Bancorp announced that Plumas Bancorp has been included in the Russell 2000 Index by FTSE Russell. The announcement was made after the U.S. stock market closed on June 26, 2020.
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NBSE | Hot Stocks09:06 EDT NeuBase Therapeutics added to Russell 3000, Microcap Indexes - NeuBase Therapeutics announced that it has been added to the Russell 3000 and Russell Microcap Indexes at the conclusion of the 2020 Russell indexes annual reconstitution.
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PS | Hot Stocks09:05 EDT Frontier Software leverages Pluralsight to close skills gaps - Pluralsight announced that Frontier Software is partnering with Pluralsight to upskill its workforce and modernize its technologies while executing on its mainstay software solutions. Based in Australia, Frontier Software provides integrated HR and payroll solutions to more than 1,500 organizations across 23 countries throughout Europe, Asia Pacific and the Far East, including payroll services to nearly 10% of Australia's workforce. To keep up with the rapid pace of change and enable the business to continually evolve to meet client expectations in the age of technology, Frontier Software has partnered with Pluralsight to implement a technology skills development strategy that will close its skills gaps and transition the company's manual processes to intelligent workflow automation and robotic automated processes.
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GOVX | Hot Stocks09:04 EDT GeoVax Labs to participate in webinar on COVID-19 vaccines - GeoVax Labs announced that its Chief Scientific Officer Emeritus, Harriet Robinson, PhD, will be an invited speaker during a webinar on the topic "The Fight Against COVID-19: What We Know About Vaccines." The webinar will be held on July 1, 2020 and is sponsored by the Sheikh Hamdan Bin Rashid Al Maktoum Award for Medical Science. Registration for the webinar is available at www.dicms.ae/covid19/#/home. During the webinar, Dr. Robinson will speak on the "prospects of a SARS-COV-2 vaccine." Also speaking during the webinar will be Stanley Plotkin, MD, a world-renowned vaccine expert and member of GeoVax's Scientific Advisory Board. Dr. Plotkin will speak on the topic "vaccine for a difficult target." GeoVax's COVID-19 vaccine effort, currently in animal challenge testing, is based on a unique multi-antigen approach utilizing its Modified Vaccinia Ankara Virus Like Particles platform technology. GV-MVA-VLP is built on a proprietary MVA vector system that is optimized for high expression and stable transgenes during manufacture. Similar to its parent MVA, it has the advantages of being a live replication-competent vector in avian cells for manufacturing, yet replication-deficient in mammalian cells for vaccination, thus inherently safe. Importantly, GV-MVA-VLP vaccines elicit protective T cell as well as antibody responses in animals and humans. In non-clinical studies, GV-MVA-VLP vaccine candidates against various virus families induced strong antibody and T cell responses and conferred full protection after single dose vaccinations against lethal challenges. Single dose protection is a favourable characteristic of preventive vaccines for response to an emerging infectious disease outbreak, given the speed of spread of pathogens and the impracticality of multi-dose regimens in the under-resourced settings where outbreaks often occur.
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PHG | Hot Stocks09:02 EDT Philips expands remote clinical collaboration offering based on Reacts platform - Royal Philips announced that it is expanding its remote clinical collaboration and virtual training offerings across its portfolio, building on the IIT Reacts collaborative platform. Leveraging innovative technologies, such as augmented reality, for remote virtual guidance, supervision and training, the platform provides unique interactive tools designed to meet the multi-faceted collaborative needs of healthcare professionals and patients. The Reacts platform has already been deployed in more than 80 countries, across various disciplines in both clinical and educational settings. It allows healthcare professionals to interact remotely and dynamically in a wide range of applications, from teleconsultations, secure messaging, remote wound care and tele-ultrasound, to interactive telesurgical assistance and remote procedure supervision.
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STM | Hot Stocks09:01 EDT STMicroelectronics extends USB fast charging over USB-C to embedded applications - STMicroelectronics is facilitating modernization of battery-powered products to capture the advantages of the latest USB Power Delivery technology including faster charging and easy reuse of USB-C chargers and cables. The universal fast-charging ecosystem is rapidly expanding as products like mobile handsets gain ever-larger batteries. The latest USB PD chargers can have power ratings up to 100W and can optimize charging by dynamically adjusting current and voltage thanks to the USB Programmable Power Supply feature of USB PD. A huge diversity of products such as smart speakers, power tools, wearables, robots, gaming controllers, power banks, and drones -- traditionally recharged at 5V through older USB micro-B or proprietary connectors -- can now leverage this ecosystem to benefit from the advantages and interoperability of USB-C technology while charging faster.
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HRTG AIG | Hot Stocks09:01 EDT Heritage Insurance enters agreement with member companies of AIG, Safeco - Heritage Insurance (HRTG) announced that it has entered into an agreement with member companies of AIG (AIG) and Safeco Insurance, a Liberty Mutual company, to offer AIG's private client group, or PCG, agents the ability to transition their upper middle market personal insurance business to Safeco and Heritage. As part of AIG PCG's decision to focus its personal lines business on the high net worth segment, Heritage will offer policy renewals to a select portion of AIG PCG's personal lines business that provides upper middle market clients with homeowners coverage.
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HRTX PCRX | Hot Stocks09:00 EDT Heron receives Complete Response Letter from FDA for pain treatment - Heron Therapeutics (HRTX) announced that it received a Complete Response Letter from the Food and Drug Administration on June 26 regarding its New Drug Application for HTX-011 for the management of postoperative pain. The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information, Heron said in a statement. It added, "Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues or CMC issues. There are four non-clinical issues in the CRL, none of which relate to any observed toxicity. Three relate to confirming exposure of excipients in preclinical reproductive toxicology studies, and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage. We do not believe that any of the issues are significant barriers to ultimate approval, as all of the excipients have extensive histories of use in pharmaceuticals and the specification can be revised. The Company will request a Type A meeting to obtain agreement with the Agency on our responses and resubmit the application as quickly as possible." Shares of Heron are down 11% to $17.55 in premarket trading while Pacira Biosciences (PCRX), which sells Exparel as a pain treatment, is up 10% to $48.40.
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LTRN | Hot Stocks08:58 EDT Lantern Pharma's AI platform for precision oncology surpasses 450M data points - Lantern Pharma announced that it surpassed the milestone of 450 million curated data points being utilized in its proprietary A.I. and machine learning-powered platform, RADR. RADR leverages genomic, transcriptomic, clinical and drug sensitivity data points across more than 145 drug-tumor interactions to predict the potential response cancer patients will have to potential drugs, therefore enabling a more personalized approach to therapy that is aimed at better outcomes. Lantern is establishing collaborations and partnerships to expand the functionality of RADR, including algorithms that can operate 200 to 300 percent faster than its existing algorithms, enabling the company to develop robust gene signatures that can be used to guide patient enrollment in trials and as a companion diagnostic. During the most recent data enrichment campaign, Lantern focused on significantly increasing the depth and amount of data for: non-small cell lung cancer, ovarian cancer, glioblastoma, and gliomas. Reaching this milestone of over 450 million curated data points for oncology drug development will bring greater precision and speed in helping Lantern with its objective of personalizing oncology therapy with reduced risk and cost. As a pioneer in the application of machine learning to oncology-focused drug development and clinical trial design, Lantern has published gene signatures derived from RADR as posters and presentations at both ASCO and AACR. Lantern's pipeline of compounds includes one candidate in an active Phase 2 clinical trial for metastatic, hormone-refractory prostate cancer using a genomic signature for patient selection; another candidate in preparation for a Phase 2 clinical trial in non-small cell lung cancer in a targeted patient population; and a third candidate in two preclinical programs for biomarker-defined solid tumors and glioblastoma. Lantern Pharma is ahead of the initial platform development schedule, reaching 400 million data points by the end of 2020, which puts Lantern on track to reach over 1 billion data points earlier than expected. The developmental focus on increasing the number of data points, and improving the performance of the algorithms is expected to yield additional targeted indications for Lantern's current pipeline of drugs, and also help to uncover additional compounds and therapies that can be in-licensed or acquired and subsequently developed in a more efficient manner that leverages the insights from Lantern's data-driven, A.I.-enabled approach.
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PCRX HRTX | Hot Stocks08:55 EDT Pacira jumps 6% after Heron pain drug given Complete Response Letter
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FLDM | Hot Stocks08:55 EDT Fluidigm says muti-site study of COVID-19 using Mass Cytometry Technology - Fluidigm announced that Fluidigm mass cytometry technology and the Maxpar Direct Immune Profiling Assay are being utilized in a prospective observational cohort surveillance study of up to 2,000 adult participants hospitalized with COVID-19. Ten leading U.S. medical institutions are engaging in the study, sponsored by the National Institutes of Health and entitled Immunophenotyping Assessment in a COVID-19 Cohort. The study could help inform recommendations for COVID-19 care and potentially identify new strategies and optimal timing for experimental treatments. Investigators at the NIH National Institute of Allergy and Infectious Diseases, in collaboration with the Human Immunology Project Consortium and the Asthma and Allergic Diseases Clinical Research Consortium, are exploring how certain immunological responses correspond to, or may even predict, the clinical severity of COVID-19. COVID-19 patients age 18 and older are enrolled in the study within 36 hours after admission to a hospital. Samples are collected from nasal swabs, blood and tracheal fluid at 10 time points from hospital admission to up to one year after discharge. When possible, researchers will also examine lower airway secretions collected from patients requiring a ventilator for breathing support. As IMPACC study patients recover, investigators will continue to evaluate their immune responses to identify factors that may relate to long-term protection against re-infection. Institutions participating in the study are Brigham and Women's Hospital; University Hospitals Case Medical Center; University of California, Los Angeles Department of Medicine; University of California, San Francisco School of Medicine; Drexel University College of Medicine; Emory University School of Medicine; Icahn School of Medicine at Mount Sinai; Oregon Health & Science University; Stanford Medicine's Sean N. Parker Center for Allergy & Asthma Research; and Yale School of Medicine.
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KBAL ULTA | Hot Stocks08:53 EDT Kimball International appoints Scott Settersten to board of directors - Kimball International (KBAL) announced that Director Geoffrey Stringer has decided to retire from the Board of Directors at the end of his current term, following 17 years of dedicated service. Mr. Stringer's term expires at the Company's 2020 annual meeting of shareholders on October 27, and he will not be seeking re-election. The Company has appointed Scott Settersten as an independent member of its Board of Directors, effective July 1, 2020. Settersten will also serve on the Audit Committee and will stand for election at the Company's 2020 annual meeting of shareholders. Settersten is CFO, Treasurer and Assistant Secretary for Ulta Beauty (ULTA).
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RKNEF | Hot Stocks08:51 EDT ESW continues to consider acquisition of additional securities of Optiva - In response to the press release of Optiva dated June 26, 2020 and the receipt of a related redemption notice from Optiva relating to the redemption of all of the Series A Preferred Shares of Optiva held by ESW Investment Corp., an affiliate and joint actor of ESW Capital, LLC), and the material changes related thereto, ESW announces an update to its previously disclosed investment intentions to confirm that it continues to consider the acquisition of additional securities of Optiva in the market, or through private or other transactions, and the sale of all or some portion of the securities of Optiva that it owns or controls, including the entering into of derivative or other transactions, with respect to its securities of Optiva, subject to market conditions, ESW's current and future investment objectives and developments to the business of Optiva. ESW has not eliminated any of its options with respect to how it may transact in the securities of Optiva in the future. Currently, ESW, and its joint actors, including ESW Investment Corp. and ESW Holdings, Inc., own or control 800,000 Series A Preferred Shares of Optiva, representing 100% of the issued and outstanding Series A Preferred Shares, 1,476,851 Subordinate Voting Shares of Optiva and 975,712 Subordinate Voting Share purchase warrants of Optiva, representing approximately 27.78% of the issued and outstanding Subordinated Voting Shares on a non-diluted basis and approximately 38.98% of the issued and outstanding Subordinated Voting Shares, assuming the exercise of all of the Warrants.
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NEO | Hot Stocks08:50 EDT NeoGenomics commercially launches InVisionFirst-Lung in the U.S. - Inivata announces that NeoGenomics, its strategic commercialization partner in the United States for the InVisionFirst-Lung liquid biopsy has commercially launched the test in the US. InVisionFirst-Lung is a ctDNA next-generation sequencing liquid biopsy assay testing 37 genes relevant to the care of advanced non-small cell lung cancer. The test covers all National Comprehensive Cancer Network guideline-recommended genomic drivers with FDA-approved targeted therapies for NSCLC. InVisionFirst-Lung results are delivered within seven calendar days and the test is covered by Medicare and various private insurance payers for patients with advanced NSCLC meeting certain clinical criteria.
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FBIO | Hot Stocks08:48 EDT Fortress Biotech added to Russell 3000 Index - Fortress Biotech announced that the company has been added to the Russell 3000 index, effective after the U.S. market opens today, following Russell's annual reconstitution of its U.S. and global equity indexes.
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NVAX | Hot Stocks08:47 EDT Novavax names John Herrmann CLO, Jill Hoyt CHRO - Novavax announced the appointment of Ben Machielse as EVP, CMC, with responsibility for overseeing Novavax' manufacturing, process technology, quality and regulatory functions. The Company also announced several leadership promotions: John Trizzino to EVP, chief business officer and CFO; John Herrmann III, to EVP, chief legal officer; Jill Hoyt to EVP, CHRO. Machielse was most recently CEO of rare disease company Vtesse. In 2014, Mr. Trizzino rejoined Novavax and was appointed CFO and CBO. Herrmann has been general counsel and corporate secretary since 2010, and will now also lead corporate and business development. Hoyt joined Novavax in 2008 with responsibility for human resources.
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AIR | Hot Stocks08:42 EDT AAR Corp. to divest non-core composites manufacturing business - AAR CORP. announced that it has entered into a definitive agreement to divest its aerospace composite manufacturing business after running a sale process that began earlier this year. The buyer is an affiliate of Architect Equity. The Composites business designs, fabricates and assembles composite aerospace products for customers in the commercial aerospace and defense industries. The divestiture of the Composites business, which was unprofitable in fiscal year 2020, along with AAR's previously announced cost reduction actions, are expected to drive meaningful margin improvement once demand recovers from the impact of COVID-19. Our other cost reduction actions include: Closing the Duluth, Minnesota maintenance, repair and overhaul facility and transferring the equipment to other AAR operations; Furloughing approximately 1,000 full-time employees ; Eliminating significant headcount through contractor and employee reductions; Implementing executive and other employee pay reductions; Consolidating the Goldsboro, North Carolina facility into the Cadillac, Michigan facility; Exiting underperforming contracts and product lines. Architect is an experienced investor, and AAR believes it is the right partner to leverage Composites' history of designing and manufacturing complex aerospace products, and to ensure the continued success of the business and its customers and employees going forward. The Composites business employs approximately 150 people at facilities located in Clearwater, Florida and Sacramento, California. The transaction is expected to close in the third quarter of calendar year 2020, subject to the satisfaction of customary closing conditions. Terms of the transaction were not disclosed.
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JAGX | Hot Stocks08:42 EDT Jaguar Health, Napo enter an amendment to accounts receivable purchase agreement - Jaguar Health announced that Jaguar and its wholly owned subsidiary, Napo Pharmaceuticals,have jointly entered into an amendment to the accounts receivable purchase agreement with Oasis Capital, dated May 12, pursuant to which Oasis agreed to purchase additional accounts receivable of the Company related to the sales of the Company's Mytesi drug product to Cardinal Health for the period of May 2020 through June 24. Jaguar Health said in a release, "The Spring 2020 Accounts Receivable have a gross value of $2,859,132. Per the terms of the agreement, Oasis will receive a fee of 5.45% of the $2,859,132 Spring 2020 Accounts Receivable following their purchase of the Spring 2020 Accounts Receivable for $1,215,131, an increased percentage of the gross accounts receivable compared to the April 2020 purchase. As with the April 2020 sales of Mytesi, Oasis will return to the Company any amount that exceeds the sum of the Purchase Price and the Fee. As with all Mytesi gross sales, the Spring 2020 Accounts Receivable will be reduced by Medicare, ADAP 340B chargebacks, returns, and wholesale distribution fees based on historical trends to determine net sales. Under the amendment, Oasis is entitled to a one-time transaction fee of $10,000."
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LEAF | Hot Stocks08:42 EDT Leaf Group investors send letter to board to remove CEO, sell certain assets - Investors, owning over 40% of the issued and outstanding shares of Leaf Group, released a letter to the company's board of directors "expressing their concern with the current corporate strategy, management team and lack of corporate governance." The list of signatories to the letter includes Osmium Partners, PEAK6 Investments, Boyle Capital Opportunity Fund, Oak Management, Generation Capital Partners II, Spectrum Equity Investors and Spectrum Equity Associates and is comprised of several of the company's largest and longest-standing shareholders. The investors said, "In the letter, the Investors contend that the Company is not realizing its full potential, and there are clear opportunities to unlock shareholder value. In order to address many of the issues plaguing the Company, the Investors call on the board to immediately: Remove the Company's CEO, Enhance corporate governance by refreshing and de-staggering the board, and Sell both the Media and Marketplace assets of the Company."
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OSTK | Hot Stocks08:41 EDT Overstock.com awarded GSA contract for commercial e-marketplace platform - Overstock.com was awarded a U.S. government contract with the General Services Administration as one of three online retailers providing business-to-business e-commerce capabilities for federal agencies. The GSA Commercial e-Marketplace Acquisition contract leverages Overstock's technology and 20 years of experience in B2B and B2C e-commerce to the government with easy access to furniture, supplies, and other commercial off-the-shelf goods. GSA expects to have the e-commerce platform ready to launch in approximately thirty days. The platform will allow GSA to test the use of commercial e-commerce portals for purchases below the micro-purchase threshold of $10,000 using a proof-of-concept. As part of GSA's e-commerce platform, Overstock will help federal agency employees save time and taxpayer dollars on the company's commercial marketplace and will help GSA streamline its spend data to increase efficiency. According to GSA, open market purchases on government purchase cards represent an estimated $6 billion annually. The platform will offer a wide assortment of products from established partners, and will allow government personnel to easily find, research, and order necessary COTS products, including many items from small businesses. Along with the commercial e-commerce platform, Overstock will provide concierge customer care service to aid with efficiency and ensure a top-of-the-line experience for government purchasers.
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HRTX | Hot Stocks08:40 EDT Heron Therapeutics trading halted, news pending
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VERU | Hot Stocks08:39 EDT Veru added to Russell 2000, 3000 Index - Veru announced that it has been added to the Russell 2000 Index and the Russell 3000 Index.
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OSIS | Hot Stocks08:38 EDT OSI Systems receives $60M in orders - OSI Systems announced that its Security division received orders valued at approximately $60 million from a U.S. customer to provide several platforms of its cargo inspection systems and solutions, related upgrades, integration and maintenance services.
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GNSS | Hot Stocks08:38 EDT Genasys added to Russell 3000 Index - Genasys announced that it joined the broad-market Russell 3000 Index at the conclusion of the annual Russell U.S. Indexes reconstitution.
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SMED | Hot Stocks08:37 EDT Sharps Compliance joins Russell 2000, 3000 Indexes - Sharps Compliance announced that it has been added to the U.S. broad-market Russell 3000 and Russell 2000 Indices.
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LOW | Hot Stocks08:36 EDT Lowe's announces $100M in bonuses for U.S. associates - Lowe's announced $100M in bonuses to recognize and reward front-line associates for their contributions, increasing the company's total commitment to associates and communities during the pandemic to more than $450M. All active hourly associates in Lowe's U.S. stores, distribution centers and store support centers will receive the bonuses in mid-July. Full-time hourly associates will receive $300 and part-time and seasonal associates will receive $150. In addition to these bonuses, Lowe's increased pay for full-time, part-time and seasonal associates by $2 per hour for the month of April. The company also previously announced $87M in profit-sharing bonuses to front-line associates in June and continues to offer telemedicine services to all associates and their families, even if they are not enrolled in Lowe's medical plans.
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SF LKQ | Hot Stocks08:36 EDT Stifel Financial hires Rob Wagman as senior advisor - Stifel Financial (SF) announced the hiring of Rob Wagman, former President and CEO of LKQ Corp. (LKQ), as a senior advisor. He will primarily work with Stifel's growing investment banking team, which includes a diverse group of senior investment bankers covering all facets of the global automotive, mobility, capital goods, auto aftermarket, and auto technology sectors. Mr. Wagman currently serves as a board member to a number of leading automotive aftermarket and industrial companies and brings to Stifel more than three decades of experience as a senior executive.
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PFSW | Hot Stocks08:35 EDT PFSweb pledges commitment to advance diversity, inclusion - PFSweb is pledging its commitment to workplace diversity and inclusion. Specifically, the company has engaged The FutureWork Institute to help develop a phased approach for further enhancing diversity and inclusion within the company. FWI will help lead PFSweb through a three-phased approach, including Admission, Listening, and Action, where the company will enable permanent change within the organization and advocate for permanent change within our communities. Throughout the phases, interviews, focus groups and surveys are conducted to gather valuable insights and data. In addition, CEO Mike Willoughby has signed the CEO Action for Diversity & Inclusion pledge, the largest CEO-driven business commitment to advance diversity and inclusion within the workplace. The pledge outlines a specific set of actions that participating organizations will take to cultivate diversity, including: Creating and maintaining a workplace environment that allows for conversations about diversity and inclusion; Implementing and expanding unconscious bias education to help employees recognize, acknowledge, and minimize any potential blind spots they may have; Sharing both successful best practices and programs and unsuccessful actions around diversity and inclusion; and Creating and sharing strategic inclusion and diversity plans with their board of directors or equivalent governing bodies.
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ARTL | Hot Stocks08:34 EDT Artelo Biosciences expands Stony Brook commercial license agreement - Artelo Biosciences announced that it has expanded its existing research and worldwide commercial license agreement with The Research Foundation For The State University of New York, Stony Brook. Artelo has obtained exclusive rights to recently developed, third-generation fatty acid binding protein 5 inhibitors. The company plans to select a lead cancer therapeutic compound from these compounds, as well as to identify additional candidates for pain, inflammation and other conditions, facilitating a potentially significant expansion to the company's development pipeline. Many of the third generation FABP5 inhibitors have shown greater potency and/or selectivity to FABP5. Fatty acid binding proteins are intracellular lipid chaperones, and transport fatty acids, including the endocannabinoids anandamide and 2-arachidonoylglycerol, as well as related N-acylethanolamines. Inhibition of FABP5 has been shown to suppress the growth and migration of breast and prostate cancers in preclinical models, and may have the potential to treat pain, based on animal studies where elevated levels of endocannabinoids showed beneficial effects on measures of stress, pain, and inflammation.
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ALRN | Hot Stocks08:33 EDT Aileron begins enrollment in schedule optimatization part of Phase 1b/2 study - Aileron Therapeutics announced that it has enrolled the first patient in the open-label Phase 1b schedule optimization part of its ongoing Phase 1b/2 clinical trial, evaluating ALRN-6924's potential to protect patients against chemotherapy-induced toxicities. Patients in this open-label trial have p53-mutated extensive disease small cell lung cancer and are being treated with second-line topotecan following administration of ALRN-6924. The schedule optimization part of the trial is intended to determine whether ALRN-6924 given six hours before topotecan further enhances the protective effect of ALRN-6924 against severe hematological adverse events observed when ALRN-6924 was given 24 hours before topotecan in the dose optimization part of the trial, as reported by Aileron earlier this month. ALRN-6924's novel mechanism of action leverages the innate ability of intracellular p53 protein to induce cell cycle arrest in healthy cells to prevent toxicities driven by chemotherapy's off-target effects in bone marrow and potentially other tissues and organs. In patients with p53-mutant cancers, which represent approximately 50% of all cancer patients, ALRN-6924 is designed to shield healthy cells from chemotherapy while preserving the susceptibility of cancer cells to chemotherapy. The ongoing Phase 1b/2 study is designed to identify an optimal dose and schedule of ALRN-6924 administration to reduce chemotherapy toxicities such as severe anemia, thrombocytopenia, and neutropenia caused by topotecan in patients with small cell lung cancer. There are two parts to the Phase 1b study: dose optimization and schedule optimization. In the dose optimization part, which enrolled 18 patients, ALRN-6924 was administered at three dose levels 24 hours before each dose of topotecan on days 1 through 5 of every 21-day treatment cycle. An expansion cohort of the dose optimization part of the trial at the 0.3 mg/kg dose level is ongoing. Aileron announced positive interim findings from this part of the trial in June 2020. ALRN-6924 demonstrated a protective effect against severe chemotherapy-induced anemia and thrombocytopenia across all dose levels as compared to historical controls. In addition, patients treated with 0.3 mg/kg ALRN-6924 met the protocol-defined criteria for reduction of NCI CTC Grade 3/4 neutropenia to less than or equal to50% in the first treatment cycle triggering the expansion cohort in up to eight patients. In the schedule optimization part, ALRN-6924 is being administered at two dose levels 6 hours before each dose of topotecan on days 1 through 5 of every 21-day treatment cycle. Aileron expects to enroll approximately 20 patients in this part of the study. While enrollment in the 6-hour dosing schedule is underway, Aileron is continuing to enroll patients in the expansion cohort of its 0.3mg/kg dose level using the 24-hour schedule. As previously reported, the company plans to report topline data from the schedule optimization and final data from the dose optimization parts of the trial in the fourth quarter of 2020. Aileron expects that these results will enable the company to determine a recommended ALRN-6924 dose and schedule for subsequent trials. Aileron is carefully monitoring the effect of the coronavirus pandemic on its clinical trial sites and the healthcare system, which may impact the future timing of the trial and the company's planned data announcements.
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RVT | Hot Stocks08:33 EDT Royce Value Trust receives Glass Lewis recommendation for advisory agreement - Royce Value Trust announced that Glass Lewis recommends that stockholders vote in order to approve the new investment advisory agreement with Royce Investment Partners, the Fund's investment manager. Glass Lewis is the second independent proxy advisory firm to recommend that stockholders vote for the agreement on the white proxy card. As previously announced on June 24, Institutional Shareholder Services, or ISS, has also recommended that the fund's stockholders vote for the agreement. "We are pleased that Glass Lewis and ISS recognize that approval of the new investment advisory agreement with Royce is in the best interest of all stockholders," said Christopher Clark, president of Royce Value Trust. "Voting 'FOR' the new investment advisory agreement ensures the Fund continues to operate and execute the strategy that has delivered superior relative returns and an impressive performance record for stockholders."
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DD | Hot Stocks08:29 EDT DuPont announces expanded distribution agreement with Essential Ingredients - DuPont and Essential Ingredients have reached an expanded distribution agreement in which Essential Ingredients will be the exclusive distributor for DuPont's cleaning enzyme solutions in the United States and Canada for the household, industrial and institutional market segment.
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LIVX | Hot Stocks08:26 EDT LiveXLive Media paid subscribers increases to record 873,000 - LiveXLive Media announced the international pay-per-view, or PPV, event with Monsta X sold out of all $149.99 VIP packages in just two minutes with still more then 30 more days of ticket sales remaining. Ticket sales kicked off on June 26 on LiveXLive's site and apps. The upcoming Monsta X PPV concert follows LiveXLive's recent 90-minute special in partnership with Live Nation, Lift Every Voice: A Juneteenth Special which garnered over 3M views, as well as this past weekend's Shaq's Fun House vs. Gronk Beach live stream which garnered over 9M views. Since January 1, LiveXLive has live streamed 59 live music events and 1,200 artists, an increase of over 300% and over 1100%, respectively, as compared to the same time period last year. LiveXLive's platform has generated over 78M live stream views and over 5B video views on TikTok. LiveXLive paid subscribers has increased to a record 873,000 and has achieved a total potential reach of 7.3B between press and social.
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CRBP | Hot Stocks08:25 EDT Corbus Pharmaceuticals presents data on ACR CRISS Score - Corbus Pharmaceuticals Holdings announced the presentation of 3 abstracts at the 6th Systemic Sclerosis World E-Congress. The data presented in these abstracts show that the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score positively correlates with improvements in multiple patient-reported outcomes. Importantly, the ACR CRISS score also correlates more strongly with these patient-reported outcomes than change in modified Rodnan Skin Score. Together, these data show that the ACR CRISS score broadly reflects changes from baseline in how patients feel and function. These data will be presented in a recorded oral presentation and two e-posters at the 6th Systemic Sclerosis World E-Congress on June 29, 2020. Two live discussions sessions for the oral presentation will be held during the Live Congress on July 12, 2020 at 16:00-16:30 UCT+2 time and on July 13, 2020 at 11:30-12:00 UCT+2 time. All three abstracts will be published in the Journal of Scleroderma and Related Disorders. In addition, the Company announced it will sponsor a satellite symposium titled "The Role of the Endocannabinoid System in Chronic Inflammation and Fibrosis" hosted by Professor Christopher Denton, MB, BS, PhD, FRCP, Head of Centre and Consultant Rheumatologist, University College London Division of Medicine, and Tracy Frech, M.D., MS, Director of the Systemic Sclerosis Clinic at the University of Utah Hospital and the Director of Clinical Trials for the Division of Rheumatology. The symposium will be held at the Live Congress on Sunday, July 12, 2020 at 14:30 UCT+2 time. Once the presentation is made public, it will be available along with the three abstracts on the Company's website in the Scientific Conferences section.
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TLSA BMY | Hot Stocks08:25 EDT Tiziana announces agreement with STC Biologics for manufacturing of TZLS-501 - Tiziana Life Sciences (TLSA), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, announces the execution of an agreement with STC Biologics for GMP manufacturing of TZLS-501, an anti-IL-6 receptor monoclonal antibody acquired from Novimmune in 2017, currently in agreement with Bristol Myers Squibb (BMY). Tiziana is simultaneously developing an inhalation technology, in collaboration with Sciarra Laboratories, for the direct delivery of TZLS-501 into the lungs using a handheld inhaler or nebulizer for treatment of patients with COVID-19. The proprietary novel technology to administer TZLS-501 directly into the nasal passages or lungs by inhaler or nebulizer has potentially significant clinical advantages for the treatment of COVID-19 patients. The company recently submitted a patent application for the inhalation delivery of anti-IL6R-monoclonal antibody for the treatment of COVID-19. "We are aggressively advancing GMP manufacturing of TZLS-501 concurrently with the development of inhalation technology using a hand-held nebulizer and safety toxicology studies in cynomolgus monkeys. Our objective is to submit an Investigational New Drug Application in the first quarter of 2021 for the treatment of COVID-19 patients," said Kunwar Shailubhai, Ph.D., CEO and CSO of Tiziana Life Sciences.
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IO | Hot Stocks08:23 EDT ION Geophysical, PGS to collaborate on 2D exploration data - ION Geophysical and PGS announced an agreement to collaborate globally on 2D exploration data. Both companies have multi-client data libraries that together cover significant hydrocarbon provinces around the world. The new joint data library will comprise nearly a million kilometers of data, including many areas of genuine broadband seismic, that have opportunity for integration and reimaging. Drawing on ION's latest imaging technology and PGS' broadband 2D GeoStreamer offering, the companies will produce deliverables with higher resolution and greater spatial coverage, offering insights and more pre-stack attributes for exploration screening on a global basis. ION and PGS intend to develop an integrated 2D seismic data library over time, creating an environment to inform exploration business decisions for E&P operators. The combined data library will be jointly marketed.
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ARCT | Hot Stocks08:23 EDT Arcturus Therapeutics added to Russell 2000 Index - Arcturus Therapeutics announced that it will be added to the Russell 2000 Index, as part of the 2020 Russell indexes reconstitution.
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HFFG | Hot Stocks08:22 EDT HF Foods Group secures lower fixed interest rate on $80M floating rate debt - HF Foods Group has secured a lower fixed interest rate on $80M of its floating rate debt with J.P. Morgan Chase, potentially reducing the Company's anticipated interest expense in the coming years. On June 24, 2020, HF Foods Group entered into an interest rate swap contract for the notional amount of $80M with its current lender, J.P. Morgan Chase. Under the terms of the agreement, $80M of the Company's floating rate loan portfolio will now be fixed at an interest rate of 0.413% plus the agreed spread from June 30, 2021 to June 30, 2025. The Company's existing term loan of approximately $74.3M was pegged to a floating rate of 1-month LIBOR+ 1.875% per annum, whereas the revolving line of credit was pegged to 1-month LIBOR + 1.375% per annum. The IRS contract effectively locks in the Company's future interest expense at 2.288% per annum for the Company's outstanding term loan and 1.788% per annum for a portion of the revolving line of credit up to an aggregate amount of $80M during the contract period, mitigating the potential risk of rising interest rates from June 30, 2021 to June 30, 2025.
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AWH VRML | Hot Stocks08:21 EDT Aspira Women's Health enrolls first patient in OVANex study - Aspira Women's Health announced the first patient enrolled in a national clinical study of benign pelvic mass management. The study will enroll over 1,000 women for assessing ovarian cancer risk in women who have an adnexal mass and a high probability for developing the disease. In this recently launched study, ovarian cancer risk will be assessed by a newly developed, multi-biomarker, proprietary algorithm based on AWH's experience and vast specimen bank in developing algorithms and FDA-cleared products for assessing ovarian cancer risk. This study will enroll women in three distinct cohorts; women with pelvic masses without symptoms, women with pelvic masses with indeterminate symptoms, and women without pelvic masses that are high risk for ovarian cancer due to hereditary genetic risk. The primary objective is to determine which patients are low risk and can be monitored without surgery, and which women are at higher risk and need to be sent for further clinical assessment.
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FRG | Hot Stocks08:20 EDT Franchise Group added to Russsell 2000 Index - Franchise Group announced it was added as a member of the U.S. small-cap Russell 2000 Index, effective after the U.S. markets opens on June 29th, as part of the 2020 Russell indexes reconstitution
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ORGS | Hot Stocks08:19 EDT Orgenesis added to Russell 3000 Index - Orgenesis announced that it has been added to the Russell 3000 Index, following the annual Russell indexes reconstitution.
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OVID | Hot Stocks08:18 EDT Ovid Therapeutics added Russell 2000, 3000 Indexes - Ovid Therapeutics announced that it has been added to the Russell 2000 and the Russell 3000 indexes following the annual reconstitution.
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AMRK | Hot Stocks08:17 EDT A-Mark Precious Metals joins Russell 3000 Index - A-Mark Precious Metals was added to the broad-market Russell 3000 Index at the conclusion of the annual reconstitution of the Russell indexes.
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PWFL | Hot Stocks08:16 EDT PowerFleet joins Russell 3000 Index - PowerFleet was added to the broad-market Russell 3000 Index at the conclusion of the annual reconstitution of the Russell indexes.
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SCS | Hot Stocks08:15 EDT Steelcase partners with MIT researchers for safer workplaces - Steelcase announces its collaboration with MIT professor and disease transmission specialist Dr. Lydia Bourouiba, director of The Fluid Dynamics of Disease Transmission at MIT to study disease transmission in the workplace. Bourouiba specializes in fluid dynamics and understanding properties of turbulent gas clouds that are produced when people exhale, sneeze or cough and how that spreads respiratory pathogens. The goal of the research is to not only understand how these pathogens spread in typical office layouts, but also to develop design strategies for how to mitigate the spread of COVID-19 and other illnesses at work. Steelcase will be working with Dr. Bourouiba to conduct combined laboratory testing and modelling of furniture configurations and materials to determine the best combinations for reducing the spread of respiratory diseases. The work will happen over a series of phases, insights immediately benefiting organizations by providing best practices to assist in retrofitting or reconfiguring existing workplaces. In future phases, the teams will focus on advanced mitigation strategies supported by scientific research, mathematical algorithms, and modeling to inform better workplace designs. While many employees are currently working from home due to the COVID-19 crisis, the vast majority, 88-90%* want to work in an office again. In order for employees to return though, the workplace must be safe. Steelcase data about the most common office configurations among its global customers shows that 98% of seats in the office will be at risk. This means these settings do not have either 6 feet of distance between the next closest employee or a space divider that is 54 inches high. Workplaces that were designed to foster creativity and innovation now must be reimagined to help mitigate the spread of disease.
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UNFI | Hot Stocks08:15 EDT United Natural Foods reaches long-term supply agreement extension with NCG - United Natural Foods and National Co+op Grocers, or NCG, announced they have reached a long-term supply agreement extension for UNFI to continue as the primary grocery wholesaler and national distributor to NCG-affiliated retail food co-ops. United Natural Foods said in a release, "NCG is one of UNFI's largest customers. UNFI and NCG have worked together since NCG's inception in 1999, with UNFI primarily supplying NCG member co-ops with a wide variety of natural products. With the signing of this new agreement, NCG and UNFI will focus on numerous business development initiatives resulting from UNFI's expanded offering, providing NCG's 147 member co-ops access to over 250,000 SKUs of natural, organic, conventional, specialty, bulk, and wellness products. This offering includes the addition of UNFI's Brands+ portfolio and its more than 5,000 products across 200 store categories. To support its members, NCG is working closely with UNFI to find the best program offerings within the over 150 customizable solutions designed to provide operational flexibility and financial savings through UNFI's Professional Services division."
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IDEX | Hot Stocks08:15 EDT Ideanomics subsidiary announces delivery of $3.15M order - Ideanomics announced that its mobile energy global, or MEG, subsidiary, Qingdao Ai Neng Ju New Energy has completed delivery of multiple orders for a total of 117 units. Total value of complete delivery orders is $3.15M. The multiple orders consisted of 25 Dongfeng Heavy Truck units ordered by Hangzhou Deqian, 40 Aoxin EV500 logistic vehicles for Jiudao Group and various customer orders for a combined 52 units of various electric vehicle types. As part of the delivery, the financing, licensing, insurance, vehicle registration plate administration and tax invoice issuance are all complete.
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CBIO | Hot Stocks08:14 EDT Catalyst Biosciences added to Russell 2000 Index - Catalyst Biosciences announced that it has been added to the Russell 2000 Index.
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CDTX | Hot Stocks08:14 EDT Cidara Therapeutics added to Russell 3000 Index - Cidara Therapeutics announced that it has been added to the Russell 3000 Index at the conclusion of the Russell indexes annual reconstitution.
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SLNO | Hot Stocks08:13 EDT Soleno Therapeutics added to Russell 3000 Index - Soleno Therapeutics announced that it has been added to the Russell 3000 Index at the conclusion of the Russell indexes annual reconstitution.
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BLPH | Hot Stocks08:12 EDT Bellerophon added to Russell 3000, Microcap Indexes - Bellerophon Therapeutics announced that the company has been added to the Russell 3000 and Microcap Indexes at the conclusion of the Russell indexes annual reconstitution.
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CMG GRUB | Hot Stocks08:12 EDT Chipotle announces partnership with GrubHub to expand delivery footprint - Chipotle (CMG) announced that it is partnering with Grubhub (GRUB) to expand its delivery footprint in the U.S. Chipotle and Grubhub have established a fully-integrated partnership to provide operations and a diner experience, ensuring food arrives "as fresh and fast as possible." Available now, customers can order from Chipotle locations through the Grubhub app or Grubhub.com. Digital orders from Chipotle are customized via the brand's Digital Kitchens, which are comprised of a dedicated ingredient station and operated by a special team in nearly all Chipotle locations. Chipotle deliveries also feature a tamper evident packaging seal to help ensure food is untouched during delivery. Grubhub users will also default into contact-free delivery, which allows diners to request their food be left in the lobby or at the doorstep.
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IMMP MRK | Hot Stocks08:12 EDT Immutep completes recruitment for Part A of Phase II TACTI-002 study - Immutep Limited (IMMP) reports it has enrolled and safely dosed the last patient for stage 2 of Part A of its TACTI-002 Phase II study, completing recruitment for Part A. TACTI-002 is being conducted in collaboration with Merck & Co (MRK) and is evaluating the combination of Immutep's lead product candidate, eftilagimod alpha with MSD's KEYTRUDA. Immutep recently reported new data from TACTI-002 at the American Society of Clinical Oncology's Annual Meeting 2020, including results from stage 1 of Part A which showed an improving Progression Free Survival estimate of more than 9 months in patients with 1st line NSCLC. The Company expects to report more mature data from TACTI-002 in H2 CY20. In total 81 patients out of up to 109 are already enrolled in the trial at 12 clinical sites across Australia, Europe, the UK and US. Recruitment is ongoing for Part B and for stage 2 of Part C.
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LSXMA... | Hot Stocks08:11 EDT Liberty Media announces amendment to Formula One financial covenant - Liberty Media announced an amendment to the term loan and revolving credit facility of certain subsidiaries of Delta Topco Limited, the Liberty subsidiary that holds all of its interests in Formula 1. Liberty Media said in a release, "The amendment has been made to the net leverage financial covenant under the facilities agreement governing the $2,902 million first lien term loan and the $500 million first lien revolving credit facility at Formula 1. The amendment provides that, subject to compliance by Formula 1 with certain additional conditions, the net leverage financial covenant shall not apply until January 1, 2022. The relevant conditions applicable to Formula 1 include the maintenance of minimum liquidity (comprised of unrestricted cash and cash equivalent investments and available revolving credit facility commitments) of $200 million and certain restrictions on dividends, other payments and the incurrence of additional debt. Formula 1 retains an ability pursuant to the amendment to recommence the requirement to comply with the net leverage financial covenant prior to 1 January 2022 and in which case the relevant additional conditions will cease to apply. As of today, the $500 million first lien revolving credit facility is undrawn. Delta Topco Limited and its subsidiaries, together with the debt described herein, are attributed to the Formula One Group tracking stock."
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ITCI | Hot Stocks08:10 EDT Intra-Cellular announces top-line results from ITI-214 Phase I/II study - Intra-Cellular Therapies announced topline results from Study ITI-214-104, a Phase I/II translational study of single ascending doses of ITI-214, a novel, selective phosphodiesterase-1 inhibitor, in patients with chronic systolic heart failure with reduced ejection fraction. ITI-214 is the first PDE1 inhibitor to be tested in patients with HFrEF. In this study, ITI-214 improved cardiac output by increasing heart contractility and decreasing vascular resistance. Agents that both increase heart contractility and decrease vascular resistance are called inodilators. Inodilators in current clinical use are associated with the development of arrhythmias, which are abnormal heart rhythms that when serious can impair heart function and lead to mortality. ITI-214, which acts through a novel mechanism of action, was not associated with arrhythmias in this study and was generally well tolerated in all patients. The results of Study ITI-214-104 are consistent with our prior findings in preclinical models of heart failure and indicate that single-dose administration of ITI-214 can improve heart function in patients with HFrEF. These findings warrant further investigation of acute and chronic PDE-1 inhibition with ITI-214 in this patient population. The initiation of Study ITI-214-104 followed findings in preclinical models that ITI-214 had improved cardiac output through a mechanism of action different from those of available heart failure therapies. These findings in preclinical models of heart failure were published by researchers at Johns Hopkins University and Intra-Cellular Therapies scientists in the journal Circulation1. Currently available heart failure drugs that strengthen heart contractions, such as PDE3 inhibitors and ss-adrenergic agonists, are associated with potentially dangerous complications, such as arrhythmias. ITI-214 does not interact with the ss-adrenergic signaling pathway and does not stimulate abnormal rhythms in an animal model of heart failure. These experimental results demonstrated that ITI-214 may exert its effects via distinct pathways, one of which involves adenosine A2B receptor signaling, and suggest that ITI-214 may represent a mechanistically novel and potentially safe approach for the treatment of human heart failure. Study ITI-214-104 was a randomized, double-blind, placebo-controlled study of escalating single oral doses of ITI-214 in patients with HFrEF NYHA class II-III. The primary objective of the study was to determine the effects of ITI-214 on cardiac function, using echocardiography with Doppler imaging, in patients with reduced ejection fraction who were already maintained on standard-of-care treatment. Safety was evaluated by monitoring for hemodynamic effects and changes in cardiac rhythm. Thirty-five patients were enrolled in this study, 9 in each of three dose cohorts and 8 in the placebo arm. The mean age of the patients was 54; 57% were male, and 57% were black. The etiology of the heart failure was ischemic heart disease in 31% of the patients. The mean left ventricular ejection fraction at screening was 25%. In this study, compared to placebo, single doses of ITI-214 increased mean left ventricular power index and cardiac output while systemic vascular resistance and mean arterial blood pressure decreased. Reported adverse events were all mild to moderate and consisted of three occurrences of orthostatic hypotension and three episodes of non-postural hypotension. Patients were monitored by continuous telemetry, and no changes in heart rhythms were noted. No serious adverse events were reported. Further details of these results will be presented at upcoming medical conferences.
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DHR | Hot Stocks08:08 EDT Danaher operating company receives EUA for SARS-CoV-2 IgG assay from FDA - Beckman Coulter, an operating company of Danaher, announced that its Access SARS-CoV-2 IgG assay has received emergency use authorization, or EUA, from the U.S. FDA. Beckman Coulter has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the U.S., and has begun distribution of the new antibody test globally to countries that accept the FDA EUA and CE Mark. The company is able to deliver more than 30M tests a month.
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XNET | Hot Stocks08:08 EDT Xunlei announces $20M share buyback program - Xunlei announced that the board of directors of the Company has approved a plan under which the Company may repurchase up to $20M of its shares over the next 12 months. The board will review the share repurchase program periodically and, if needed, adjust its size and terms. Under the Share Buyback Program, repurchases may be made from time to time on the open market at the prevailing market prices, in privately negotiated transactions, in block trades and/or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations. The shares to be repurchased can be both its ADS and common shares. The repurchase plan will be funded from the Company's cash balance. As of March 31, 2020, the Company had cash, cash equivalent and short-term investments of approximately $255.7M, and the balance of bank borrowings was about $11.2M.
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BCDA | Hot Stocks08:07 EDT BioCardia resumes cases in CardiAMP Heart Failure Trial - BioCardia announced that the Company has resumed cases in the CardiAMP Heart Failure Trial. The first patient procedure completed since elective procedures were paused due to COVID-19 took place at Morton Plant Hospital in Clearwater, Florida this month. New consents have also taken place at additional centers. The CardiAMP Heart Failure Trial is studying CardiAMP cell therapy, an autologous bone marrow-derived mononuclear cell formulation designed to stimulate the body's natural healing response in treating heart failure which develops after a heart attack. The trial is evaluating the cell therapy's ability to improve patient survival, exercise capacity and quality of life, as well as its safety. The CardiAMP Heart Failure Trial is the first multicenter clinical trial of an autologous cell therapy to prospectively select patients based on cell potency to maximize the probability of patient benefit. The ongoing multi-center, double-blinded, randomized, controlled pivotal CardiAMP Heart Failure Trial is expected to enroll 260 patients at up to 40 centers nationwide. The national co-principal investigators are Amish Raval, MD, of the University of Wisconsin and Carl Pepine, MD, of the University of Florida, Gainesville. In March 2020, the Data Safety Monitoring Board indicated there were no safety concerns with the CardiAMP study results and recommended that the trial continue, as planned. To date, 75 patients have been enrolled at 25 active centers. The trial is sponsored, in part, by the Maryland Stem Cell Research Foundation and has reimbursement from the Centers for Medicare and Medicaid Services.
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NVEE | Hot Stocks08:06 EDT NV5 Global awarded $12M project management contract by Caltrans - NV5 Global announced that it has been awarded a $12M contract by the California Department of Transportation - District 6 to provide construction management not at risk services, including on-call construction inspection, office engineering, claims resolution, and constructability support services for transportation facilities throughout Kern, Tulare, Kings, Fresno, and Madera Counties. Work has already begun on the contract, which has a duration of 36 months.
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EMMA | Hot Stocks08:05 EDT Emmaus Life Sciences receives marketing authorization for Endari in Israel - Emmaus Life Sciences announced that it was issued a license from the Israeli Ministry of Health on June 17, 2020 granting marketing authorization for the commercial distribution and sale of Endari in Israel. Endari is approved in Israel as in the U.S. as an amino acid indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
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PTCT | Hot Stocks08:04 EDT PTC Therapeutics announces CHMP opinion to remove Translarna statement - PTC Therapeutics announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended by a majority of votes to remove the statement "efficacy has not been demonstrated in non-ambulatory patients" from the SmPC for Translarna. This label change enables healthcare professionals to use their clinical judgement to make treatment decisions for their patients on Translarna who have lost ambulation. The company said the change also should support reimbursement agencies granting continued access to Translarna for patients who become non-ambulatory during the course of their treatment. The CHMP's opinion is subject to final approval by the European Commission, which is normally granted in a two-month time frame.
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TFII | Hot Stocks08:04 EDT TFI International acquires assets of MCT Transportation for $9.6M - TFI International announced the acquisition of substantially all the assets of MCT Transportation. Originally Midwest Coast Transport, MCT Transportation was a refrigerated and dry van subsidiary of Comcar Industries, Inc., which along with its other subsidiaries filed Chapter 11 petitions in the U.S. Bankruptcy Court on May 17, 2020. TFI International paid total consideration of $9.6M for the assets acquired including accounts receivable, along with $2.8M for two real estate properties. Headquartered in Sioux Falls, South Dakota, MCT Transportation provides quality transportation for major companies in the packaged food, agricultural, medical and automobile industries, primarily throughout the Southeast and Midwest regions of the U.S., and generated 2019 revenue before fuel surcharge of approximately $45M. Its highly professional driving team operates more than 130 tractors in addition to 90 owner-operator tractors, plus 340 reefer trailers and 275 dry van trailers. MCT Transportation, which will become part of TFI International's Truckload segment, had four terminal locations, including two acquired by TFI, in Florida and Arkansas.
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TFII | Hot Stocks08:03 EDT TFI International acquires assets of CT Transportation for $15M - TFI International announced the acquisition of substantially all the assets of CT Transportatio. Originally Coastal Transport & Trading Company, CT Transportation was the flatbed subsidiary of Comcar Industries, Inc., which along with its other subsidiaries filed Chapter 11 petitions in the U.S. Bankruptcy Court on May 17, 2020. TFI International paid total consideration of $15M for the assets acquired. Founded in 1939 and headquartered in Savannah, GA, CT Transportation operates more than 270 tractors and 560 trailers, with 11 terminals from Maryland to Florida, and generated revenue before fuel surcharge of approximately $50M in 2019. Its approximately 250 drivers provide quality transportation of drywall, lumber, tiles, cement board and other materials to major building product manufacturers and home improvement distributors throughout the Southeast and Mid-Atlantic regions of the U.S. CT Transportation will become part of TFI International's Truckload segment and operate under the business name Coastal Transport.
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PLPRF | Hot Stocks07:58 EDT Plus Products completes non-dilutive share exchange, updates share structure - Plus Products announced the completion of a non-dilutive share exchange transaction, under which an existing shareholder of the Company exchanged 75,500 Common Shares for 15,100,000 newly created Class B Common Shares, on the basis of 200 Class B Subordinate Voting Shares for each Common Share. The aggregate value of the exchanged Common Shares was equivalent to the aggregate value of the newly issued Class B Subordinate Voting Shares. In aggregate, the 15,100,000 Class B Subordinate Voting Shares represent the same economic and voting rights as the 75,500 Common Shares for which they were exchanged. The Transaction will not adversely impact the economic or voting rights of current holders of Common Shares. The shareholders of the Company authorized the creation of Class B Subordinate Voting Shares by special resolution of the shareholders at the 2020 Annual General & Special Meeting held on June 15, 2020. With the creation of the Class B Subordinate Voting Shares, the Company's authorized capital consists of the following: Common Shares: Common Shares are sometimes referred to as the "Subordinated Voting Shares", and are publicly traded on the CSE and OTCQX. Each Common Share represents one vote per share at meetings of the shareholders of the Company and distributions and dividends of the Company are made pro rata based on the number of issued and outstanding Common Shares, on an as converted basis. Class A Common Shares: Class A Common Shares are sometimes referred to as the "Proportionate Voting Shares". Subject to certain restrictions, each Proportionate Voting Share is convertible into 100 Common Shares, and holders are entitled to vote and participate in economic rights, on an as converted basis, with Common Shares. Class B Common Shares: Class B Common Shares are sometimes referred to as the "Class B Subordinate Voting Shares". Subject to certain restrictions, each Class B Subordinate Voting Share is convertible into 1/200 of one Common Share, and holders are entitled to vote and participate in economic rights, on an as converted basis, with Common Shares. The Transaction was completed on a private placement basis pursuant to a share exchange agreement between the Company and Matt Schmidt, a Non-Executive Director of the Company. Mr. Schmidt owned 75,600 Common Shares, representing 0.17% of the Company's 43,288,460 issued and outstanding Common Shares, on an as-converted basis. Under the share exchange agreement, Mr. Schmidt exchanged 75,500 Common Shares for 15,100,000 Class B Subordinate Voting Shares, which are convertible into 75,500 Common Shares, subject to certain conversion limitations set forth in the Company's articles. Mr. Schmidt's voting and economic interest in the Company following the Transaction remains at 0.17% of the Company's issued and outstanding Common Shares, on an as-converted basis. The Transaction is exempt from the issuer bid requirements under applicable securities legislation due to the fact that Mr. Schmidt is a director of the Company, the value of the consideration for the Class B Subordinate Voting Shares acquired is not greater than the market price determined in accordance with applicable legislation and the aggregate number of Common Shares acquired by the Company does not exceed 5% of the outstanding Common Shares. The Transaction was structured, in part, to preserve the Company's status as a "foreign private issuer" under Rule 3b-4 of the Securities Exchange Act of 1934, as amended.
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WSPOF ASGTF | Hot Stocks07:56 EDT WSP Global, Altus Group launch GeoVerra geomatics firm - WSP Global (WSPOF) and Altus Group Limited (ASGTF) announced that the previously announced transaction to combine their respective geomatics business units has closed. The combined entity launched as GeoVerra Inc., forming a leading Canadian geomatics firm with offices in Western Canada and Ontario. With offices in 29 cities and towns across Western Canada and Ontario, GeoVerra is well equipped to serve its clients by offering a broad variety of geomatics services. Through the combination, GeoVerra has the expertise and scope to take on large, complex projects, while remaining agile to be competitive at the local level for smaller projects. GeoVerra will be led by John Nielsen as CEO, who served as Vice President, Operations, Infrastructure, at WSP Canada, and Mitch Ettinger as COO, who was President of Altus Group's Geomatics business unit.
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IMVT | Hot Stocks07:53 EDT Immunovant reports $280.4M cash balance as of June 29
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ELVT | Hot Stocks07:52 EDT Elevate Credit to exit UK market - Elevate Credit announced that its wholly-owned subsidiary in the UK, Elevate Credit International Limited, or ECIL, will cease operations in the UK effective June 29. Elevate Credit said in a release, "The ECIL Board of Directors placed the UK subsidiary in administration under the UK Insolvency Act 1986 and appointed insolvency practitioners from KPMG LLP to take control and management of the UK business. ECIL's entry into administration will place its business under the direct control of the Administrator. Accordingly, Elevate will deconsolidate ECIL as of June 29 and will present ECIL as discontinued operations starting in the second quarter of 2020. Upon deconsolidation of ECIL, Elevate will recognize an estimated net impairment loss on its investment in ECIL of approximately $10 million (which includes an estimated US federal tax benefit of $20 million). Please reference Elevate's Form 8-K filing today, which contains additional pro forma financial information. After recognizing this estimated net impairment loss, Elevate's only remaining material exposure to ECIL will be its guarantee of ECIL's repayment of its outstanding debt, which was approximately GBP 10.2 million as of June 29, 2020. As of May 31, ECIL's cash balances totaled over GBP 11 million with the book value of loans receivable, net of the allowance for loan losses totaling over GBP 11 million as well. Elevate expects ECIL to completely repay its outstanding debt obligation by the end of this year."
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IMVT | Hot Stocks07:52 EDT Immunovant plans Phase 3 registrational trial of IMVT-1401 - In March, Immunovant announced positive clinical results from ASCEND GO-1, a Phase 2a trial of IMVT-1401 in Thyroid Eye Disease, which reaffirmed IMVT-1401's prior safety and pharmacodynamic findings and demonstrated encouraging potential efficacy for patients with TED. Complementing these findings, two recent successful studies for other drug candidates with the same mechanism of action provided strong clinical validation in MG and demonstrated a within-study relationship between the degree of IgG lowering and the magnitude of clinical benefit in MG. With proof-of-biology now established for anti-FcRn agents in MG, Immunovant has chosen to accelerate Phase 3 development of IMVT-1401 in MG. "Immunovant expects to engage the FDA on the design and conduct of the pivotal program and we expect the Agency's feedback to be an important part of the final plan," said CEO Pete Salzmann. Immunovant expects to report results from ASCEND MG, a Phase 2a trial of IMVT-1401 in MG, in late calendar Q3 or early calendar Q4. As previously communicated, results from the high dose cohort of ASCEND WAIHA, a Phase 2a trial of IMVT-1401 in Warm Autoimmune Hemolytic Anemia. are still possible by the end of the second half of 2020 and results from ASCEND GO-2, a Phase 2b trial of IMVT-1401 in TED, are still possible in the first half of 2021. Immunovant intends to provide an update on its anticipated clinical development timelines for TED and WAIHA in the third quarter of calendar year 2020.
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CBWTF | Hot Stocks07:48 EDT Auxly rationalizing cultivation portfolio by focusing on domestic cultivation - Auxly Cannabis Group provided an update on the Company's national and international cultivation strategy. The Company is pleased by the progress of its cultivation portfolio, which is instrumental in supplying a secure, cost-efficient and consistent source of input material for the Company's growing portfolio of cannabis products. In order to sharpen the Company's near-term focus on Cannabis 2.0 dominance in Canada, the Company has decided to rationalize its cultivation portfolio by focusing on its domestic cultivation, while maintaining optionality in Uruguay. On June 15, 2020, the Company announced that Sunens Farms, the Company's organic cultivation joint-venture with legendary greenhouse operator Peter Quiring, secured a standard cultivation licence from Health Canada for the first phase of its fully automated, purpose-built, 1.1 million sq. ft. greenhouse facility in Leamington, Ontario. The first phase of the licensed area includes approximately 360,000 sq. ft. of cultivation, processing, and storage space, with the additional licence amendments for the remaining phases being submitted throughout the course of 2020. Since announcing receipt of the cultivation licence, the Sunens team has already commenced cultivation of organic cannabis within the licensed area. Cannabis harvested from the Sunens facility will provide Auxly with a consistent, traceable source of low-cost, organic dried flower to support Auxly's commercial strategy, including the manufacturing of Auxly's branded cannabis products at its Dosecann facility in Prince Edward Island and continued product innovation. The Company believes that the Sunens facility will be the cornerstone of its cultivation portfolio and, when fully operational, will produce approximately 100,000 kg of organic cannabis annually. On May 20, 2020, the Company announced that its wholly owned subsidiary, Robinsons Cannabis received its sales licence from Health Canada, expanding Auxly's product portfolio to include hand-crafted cannabis flower for the connoisseur market. Since receipt of its cultivation licence, Robinsons has been growing small-batch cannabis at its 27,700 sq. ft. state-of-the-art facility in Kentville, Nova Scotia. Robinsons will release a selection of its favorite genetics in select Canadian provinces in July of 2020, each grown with an uncompromising commitment to quality, flavor and craftsmanship. On November 15, 2019, the Company announced the launch of Robinsons Outdoor Grow, a large-scale outdoor cultivation project located in Hortonville, Nova Scotia, with over 158 acres of land available for development. Robinsons OG will provide the Company with access to organic, sun grown cannabis flower to help support the Company's ongoing development of Robinsons branded cannabis products. The Company is pleased to announce that Robinsons OG has secured a standard cultivation licence from Health Canada. However, given timing for the optimal outdoor planting season and the operational challenges posed by COVID-19, the Company has made the strategic decision to delay the commencement of cultivation activities at the Robinsons OG site and, instead, focus its efforts on the continued development of the Robinsons OG land and facility in preparation for the 2021 cultivation season. During 2019, the Kolab Project facility located in Carleton Place, Ontario, was focused on providing quality cannabis flower and pre-rolls to registered medical patients across Canada. In 2020, the Company made the strategic decision to cease cultivation at the Kolab facility and fully focus Kolab's operations on pre-roll manufacturing and innovation activities to support the Company's branded pre-roll product offering. Inverell is the Company's 80%-owned subsidiary located in Montevideo. Inverell has completed its 2019-2020 harvest which resulted in approximately 43,000 kilograms of packed hemp biomass. However, due to the slower than anticipated pace of cannabis-specific regulatory development in Latin America and, consequently, the slower development of viable near-term commercial channels in the region, the Company has chosen not to proceed with planting for the 2020-2021 growing season nor with the development of extraction capabilities with a view to reducing headcount and keeping operating expenditures to a minimum. This strategy will reduce future operating expenses by approximately $6-7 million annually, which can be redirected into the Canadian market with a view to driving more immediate revenue to Auxly. Auxly will maintain the optionality Inverell provides and continue to monitor the regulatory landscape in LATAM, while exploring extraction opportunities as well as sales channel opportunities for the current stored biomass into legally permissible jurisdictions.
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AKBA | Hot Stocks07:45 EDT Akebia announces approval for vadadustat in Japan - Akebia announced the first regulatory approval of vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor, or HIF-PHI, for the treatment of anemia due to chronic kidney disease, or CKD. Mitsubishi Tanabe Pharma, or MTPC, Akebia's collaboration partner in Japan for vadadustat, has obtained manufacturing and marketing approval of vadadustat as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients by the Ministry of Health, Labour and Welfare in Japan. Vadadustat will be marketed by MTPC in Japan under the trade name Vafseo.
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HROW | Hot Stocks07:45 EDT Harrow Health to join Russell 2000, 3000 Index - Harrow Health announced that it is set to join the small-cap Russell 2000 Index and the broad-market Russell 3000 Index at the conclusion of the 2020 Russell indexes annual reconstitution, effective after the US market opens this morning, according to a preliminary list of additions posted June 5.
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SYK WMGI | Hot Stocks07:44 EDT Stryker extends cash tender offer for shares of Wright Medical - Stryker (SYK) announced that Stryker B.V., an indirect, wholly owned subsidiary of Stryker, has extended the offering period of its previously announced cash tender offer for all outstanding ordinary shares of Wright Medical Group N.V. (WMGI). The tender offer is being made pursuant to the purchase agreement, dated November 4, 2019, among Stryker, Stryker B.V. and Wright Medical. The tender offer is now scheduled to expire at 5:00 p.m., Eastern Time, on August 31, 2020, unless the tender offer is further extended or earlier terminated in accordance with the purchase agreement.
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NKLA | Hot Stocks07:43 EDT Nikola to commence Badger preorders at 11 a.m. eastern time - In February, Nikola announced its entry into the electric pick-up market with its electric pickup, Nikola Badger. The company has now announced that preorders are now being accepted at 11 a.m. eastern time.
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GPL | Hot Stocks07:38 EDT Great Panther Silver announces agreement with Nystar to defer bond requirements - Great Panther Silver announced an agreement with Nyrstar International, Nyrstar Netherlands and NN2 Newco, the parent of the Nyrstar entities, to amend certain agreements in respect of the company's remediation obligations in connection with Great Panther's 2017 acquisition of the Coricancha mine from Nyrstar. The amended agreements include the share purchase agreement under which the company purchased Coricancha from Nyrstar and the related agreement for Coricancha under which Nyrstar agreed to fund a portion of the bond to secure remediation costs for Coricancha in future in respect of a permanent closure of the mine. under the amending agreements, Nyrstar has agreed to extend its remediation bond obligations beyond the original June 30, 2020 expiry date. The Amending Agreements provide that Nyrstar will maintain a $7M bond until June 30, 2021 and $6.5M for the following year, effectively deferring Great Panther's funding requirements for these amounts until June 30, 2022. The amending agreements provide that Great Panther will use commercially reasonable efforts to seek an amendment to a closure plan for certain legacy tailings facilities which Nyrstar is obligated to fund. The objective of the amendment is to seek a technically superior closure plan for approval by the Ministerio de Energia y Minas de Peru with potentially lower costs. In addition, Great Panther has agreed to pay interest on the bond amounts Nyrstar has agreed to continue to fund at an annual rate of 3-month LIBOR plus 5%, and to defer any relocation of the legacy tailings until an agreement on a modified closure plan is achieved or there is a legal requirement to move the tailings. The amending agreements also provide Nyrstar with certain offer rights for Coricancha concentrates which are secondary to those of a third party. The amending agreements do not impact on the maximum reclamation obligation that Nyrstar is obligated to fund under the share purchase agreement.
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ACRGF | Hot Stocks07:38 EDT Acreage Holdings closes acquisition of CCF of New Jersey - Acreage Holdings announced the closing of the transactions contemplated by the previously announced Reorganization Agreement, dated November 15, 2019, among Acreage, Compassionate Care Foundation, a New Jersey vertically integrated medical cannabis nonprofit corporation, and certain affiliates thereof, pursuant to which Acreage CCF New Jersey, LLC acquired 100% of the operations of CCF, and, accordingly, Acreage will subsequently consolidate the results of operations of the New Jersey medical cannabis business into its consolidated financial statements. In accordance with the terms of the Reorganization Agreement, Acreage assumed all debts, liabilities and obligations of CCF, including fees, costs and expenses to be incurred by CCF in connection with the dissolution and wind-up of CCF and paid to the former trustees of CCF an aggregate total of $10,000,000 at closing. Acreage's New Jersey vertically integrated operations include licenses for cultivation, manufacturing & processing, and three retail dispensaries. A description of the operations follows: Cultivation: Acreage operates one of New Jersey's largest indoor growing facilities, primarily for high end flower, in Egg Harbor, NJ. Acreage is planning to expand this facility to serve the existing demand for medical cannabis and in anticipation of adult-use legalization, and to build out a robust wholesale business. Retail Dispensary Operations: Acreage has licenses to operate two retail dispensaries, one in Egg Harbor and one on the iconic Atlantic City Boardwalk.
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MORF | Hot Stocks07:37 EDT Morphic Holding presents preclinical data on MORF-057 - Morphic Therapeutic announced a presentation highlighting Morphic's product candidate MORF-057 at the 2020 Digestive Disease Week virtual event. The new data presented at DDW expand on Morphic's recent oral presentation at the 15th Congress of the European Crohn's and Colitis Organisation, which support MORF-057's development as a potent, selective, and orally available small molecule inhibitor of the integrin alpha4beta7, a validated target for the treatment of inflammatory bowel disease. The data presented at DDW demonstrate MORF-057's inhibition of alpha4beta7-expressing lymphocyte migration to the gut, which is a fundamental contributor to IBD. In mice, its inhibitory activity demonstrated potency comparable to an anti-alpha4beta7 antibody. In non-human primate models, MORF-057 demonstrated important proof of mechanistic activity by driving accumulation of mucosal homing alpha4beta7-high expressing T cells in the peripheral blood, in an analogous manner to the approved anti-alpha4beta7 antibody, vedolizumab. Importantly, a MORF-057 analog demonstrated greater than90% receptor occupancy of alpha4beta7 in NHPs, providing an important indicator of the product candidate's target engagement. In biochemical assays MORF-057 demonstrated high selectivity over a broad panel of integrins. These results were consistent in cell adhesion assays, where MORF-057 showed greater than 3,000-fold targeted selectivity of alpha4beta7 integrin over its nearest family members, including alpha4beta1. MORF-057 was designed to achieve high selectivity for alpha4beta7 over alpha4beta1 to help prevent unwanted localized immune suppression potentially leading to certain adverse opportunistic infections. In contrast to small molecule or antibody inhibitors of alpha4beta1, a MORF-057 analog did not show a statistically significant increase in lymphocytes in mice in these studies.
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XOMA | Hot Stocks07:35 EDT Xoma added to Russell 2000, Russell 3000 Indexes - XOMA Corporation announced the Company has been added to the Russell 2000 and Russell 3000 Indexes following the annual reconstitution, which took effect after the U.S. market closed on June 26, 2020.
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FMC | Hot Stocks07:35 EDT FMC Corporation announces collaboration with Cyclica, terms not disclosed - FMC Corporation has entered into a collaboration with Cyclica, a biotechnology company specializing in artificial intelligence, or AI, and computational biophysics, to accelerate and improve the efficiency of discovering new crop protection chemistry. FMC said in a release, "This is among the first of several new technology collaborations and approaches that FMC is pursuing to expand its research of novel active ingredients that protect crops from diseases and destructive pests. FMC will use Ligand Design and Ligand Express, Cyclica's proprietary AI platforms, to optimize the discovery of novel compounds at a pace that far exceeds typical chemistry discovery research programs. Powered by MatchMaker, a deep learning proteome screening technology, and POEM, a machine learning technology for predicting molecular properties, Ligand Design and Ligand Express will assess millions of chemical structures, providing FMC researchers with a greater volume of high-quality molecule predictions that are specific to the pesticidal target of interest. A similar AI-augmented approach to discovery research has been used successfully for years in industries that require extensive data analysis, significant investments and lengthy development timelines, such as pharmaceuticals and healthcare. Terms of the collaboration with Cyclica are not disclosed."
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ITRM | Hot Stocks07:34 EDT Iterum Therapeutics evaluating corporate, strategic, financial alternatives
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ITRM | Hot Stocks07:33 EDT Iterum Therapeutics announces results from Phase 3 trial of oral sulopenem - Iterum Therapeutics announced topline results from its Sulopenem for Resistant Enterobacteriaceae 1 clinical trial for the treatment of Uncomplicated Urinary Tract Infections. Sulopenem is a novel anti-infective compound that, if approved, would be the first penem antibiotic with an oral formulation indicated for treatment of uUTI. In SURE1, there were two independent primary endpoints, with achievement of either of those endpoints expected to provide a potential path to marketing approval based on previous discussions with the U.S. Food and Drug Administration. In the population of patients with baseline pathogens resistant to quinolones, sulopenem achieved the related primary endpoint by demonstrating superiority to ciprofloxacin, providing substantial evidence of a treatment effect in patients with uUTI. With a p-value of less than0.001, this result was highly statistically significant. In the second population of patients with organisms susceptible to quinolones, sulopenem was not non-inferior to ciprofloxacin and did not achieve the related primary endpoint, with the difference in outcomes driven by the rate of asymptomatic bacteriuria post treatment. In SURE1, sulopenem was well tolerated with a favorable safety profile, consistent with the SURE2 and SURE3 trials. The randomized, multi-center, double-blind SURE1 clinical trial enrolled 1,670 patients to measure efficacy, tolerability, and safety of oral sulopenem/probenecid for the treatment of uUTI in adult women. Patients were randomized to receive either oral sulopenem/probenecid twice daily for five days of treatment, or oral ciprofloxacin twice daily for three days of treatment. The End of Treatment visit occurred on Day 5 and the Test of Cure Visit at Day 12. Two independent populations were prespecified and tested for an overall response of success at the TOC: a quinolone resistant population being assessed for superiority, defined as a p value less than0.05, and a quinolone susceptible population being tested for non-inferiority, based on the lower limit of the 95% confidence interval for the difference in the microbiologic-modified intent to treat population being greater than -10%. A prespecified analysis of the outcome in both susceptible and non-susceptible patients combined was also performed to describe the overall results of treatment of uUTI with sulopenem relative to ciprofloxacin. In the safety population of 1,660 patients, treatment related adverse events were observed in 11.4% and 11.9% of patients on sulopenem and ciprofloxacin, respectively. The most commonly reported adverse events were diarrhea, 7.3% and 7.6%, nausea, 3.4% and 4.0%, and headache 2.2% and 2.2%, for sulopenem and ciprofloxacin patients, respectively. Discontinuations due to adverse events were uncommon on both regimens and were seen in 1.1% of patients on sulopenem and 1.5% of patients on ciprofloxacin. Serious adverse events were seen in 0.6% of patients on sulopenem with no drug-related SAE and 0.4% of patients on ciprofloxacin with one drug-related SAE. Based on these trial results, the Company plans to request a pre-NDA meeting with the FDA to discuss its filing strategy. In parallel, the Company is also evaluating its corporate, organizational, strategic, financial and financing alternatives with the goal of maximizing value for its stakeholders, while prudently managing its resources.
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NMTR | Hot Stocks07:32 EDT 9 Meters Biopharma amends definition of primary endpoint for larazotide trial - 9 Meters Biopharma announced that, after consultation with the FDA, the company will modify its definition of the primary endpoint in the ongoing Phase 3 trial evaluating larazotide for treating celiac disease. The company said in a release, "The validated instrument used for the primary assessment remains the Celiac Disease Patient-Reported Outcome, or CeD PRO. However, the definition of the primary endpoint will now utilize a continuous variable instead of a responder analysis. The design and execution of the ongoing trial have not been affected. The trial is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of larazotide for patients with celiac disease who continue to experience gastrointestinal symptoms while following a gluten-free diet. The primary efficacy outcome of the study comprises the mean change from baseline on the CeD PRO rating scale abdominal domain over 12 weeks for two active treatment doses (0.25 mg and 0.50 mg) compared to placebo. The trial is currently underway at over 100 clinical sites, with an interim analysis still anticipated during the first half of 2021 and topline data anticipated in the second half of 2021."
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RGEN | Hot Stocks07:31 EDT Repligen to acquire Engineered Molding Technology, terms not disclosed - Repligen announced that it has entered into an agreement to acquire Albany, New York based Engineered Molding Technology, an innovator and manufacturer of single-use silicone assemblies and components used in the manufacturing of biologic drugs. EMT's standard and custom molded and over-molded connectors and silicone tubing products are key components in single-use filtration and chromatography systems. The proposed acquisition is expected to close during Repligen's third quarter of 2020. Financial details were not disclosed. Perella Weinberg Partners LP is acting as financial advisor and Goodwin Procter LLP is serving as legal counsel to Repligen.
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INCY NVS | Hot Stocks07:30 EDT Incyte announces approval of Tabrecta in Japan - Incyte (INCY) announced that the Japanese Ministry of Health, Labour and Welfare, or MHLW, approved Tabrecta for MET exon 14 skipping, or METex14, mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer, or NSCLC. Incyte said in a release, "Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type. Tabrecta is the third Incyte-discovered medicine to receive approval in Japan. Novartis has exclusive worldwide development and commercialization rights to Tabrecta. Approval of Tabrecta in Japan triggers a $20 million milestone payment to Incyte, and Incyte is also eligible to receive 12-14% royalties on global net sales of Tabrecta by Novartis (NVS)."
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ICPT... | Hot Stocks07:26 EDT Intercept plunges, drags down some NASH peers after CRL from FDA - Shares of Intercept Pharmaceuticals (ICPT) have plunged in early morning trading after the company announced that the U.S. Food and Drug Administration has issued a Complete Response Letter regarding the New Drug Application for obeticholic acid for the treatment of fibrosis due to nonalcoholic steatohepatitis, or NASH. Based on the data the FDA has reviewed to date, the Agency has determined that the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH, Intercept tells investors. Following the announcement, shares of Intercept are down $25.82, or 33%, to $51.67 in pre-market trading. A number of other companies working on NASH treatments are also moving lower, with CymaBay (CBAY) down about 3% and NGM Biopharmaceuticals (NGM) fractionally lower. Other companies exploring NASH treatments include Madrigal Pharmaceuticals (MDGL), Novo Nordisk (NVO), Genfit (GNFT), Eli Lilly (LLY), and Alnylam Pharmaceuticals (ALNY).
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PRVB | Hot Stocks07:25 EDT Provention Bio added to Russell 2000, 3000 - Provention Bio announced that it has been added to the broad-market Russell 3000 Index and the small-cap Russell 2000 Index as part of the Russell U.S. Indexes annual reconstitution.
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KNSA REGN | Hot Stocks07:25 EDT Kiniksa says Phase 3 trial of rilonacept meets efficacy endpoints - Kiniksa Pharmaceuticals (KNSA) reported data from RHAPSODY, a pivotal Phase 3 trial of rilonacept, a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha and interleukin-1 beta signaling, in recurrent pericarditis. RHAPSODY met its prespecified primary and all major secondary efficacy endpoints, showing that rilonacept improved clinically meaningful outcomes associated with the unmet medical need in recurrent pericarditis, a painful and debilitating autoinflammatory disease. The U.S. Food and Drug Administration granted Breakthrough Therapy designation to rilonacept for the treatment of recurrent pericarditis in 2019, and Kiniksa expects to submit a Supplemental Biologics License Application later this year. RHAPSODY is a global, randomized withdrawal design, pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis. The trial's primary analysis population included 61 actively symptomatic recurrent pericarditis patients who were failing standard of care treatment, including nonsteroidal anti-inflammatory drugs, colchicine, or corticosteroids, initiated rilonacept treatment during a run-in period, discontinued background medications, and achieved and maintained clinical response on rilonacept monotherapy. Clinical responders were randomized 1:1 to receive continued weekly rilonacept or placebo in a blinded manner in the randomized withdrawal period. The primary efficacy endpoint of time-to-first adjudicated pericarditis recurrence in the randomized withdrawal period was highly statistically significant. Median time to pericarditis recurrence for rilonacept recipients in the randomized withdrawal period could not be estimated due to the low number of recurrences in the rilonacept treatment arm. The median time-to-recurrence for placebo recipients was 8.6 weeks. Rilonacept recipients experienced a 96% reduction in risk of recurrent pericarditis events. All major secondary efficacy endpoints in the randomized withdrawal period were also highly statistically significant. 81% of rilonacept recipients maintained clinical response at Week 16 of the randomized withdrawal period, compared to 20% of placebo recipients. Consistent results were observed at Week 8 and Week 24 and were also highly statistically significant. The proportion of rilonacept recipients with absent or minimal pericarditis symptoms at Week 16 of the randomized withdrawal period was 81% compared to 25% for placebo recipients. Consistent results were observed at Week 8 and Week 24 and were also highly statistically significant. Rilonacept was well-tolerated in the study, with adverse events consistent with the FDA-approved label for the treatment of Cryopyrin-Associated Periodic Syndromes. The most common adverse events were injection site reactions. Additional analyses of the RHAPSODY trial results are ongoing, and Kiniksa plans to present the data at a future medical meeting or in a publication. Rilonacept was discovered and developed by Regeneron Pharmaceuticals (REGN) and is approved by the FDA under the brand name ARCALYST for the treatment of CAPS. Kiniksa licensed rilonacept from Regeneron in 2017 for evaluation in diseases believed to be mediated by both IL-1alpha and IL-1beta, including recurrent pericarditis. The FDA granted Breakthrough Therapy designation to rilonacept for recurrent pericarditis in 2019. Based on the Phase 3 RHAPSODY data announced today, the Biologic License Application (BLA) for CAPS will transfer to Kiniksa, and the company plans to submit an sBLA with the FDA in recurrent pericarditis later this year. Upon receipt of FDA approval for rilonacept in recurrent pericarditis, Kiniksa would assume the sales and distribution of rilonacept for the approved indications in the United States and will evenly split profits on sales with Regeneron.
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CUB NOC | Hot Stocks07:25 EDT Cubic teams with Northrop Grumman, Carley to pursue Navy ID/IQ contract - Cubic (CUB) announced its Cubic Global Defense, or CGD, business division has partnered with Carley and Northrop Grumman (NOC) to pursue the U.S. Navy's potential $93M Indefinite Delivery/Indefinite Quantity, or ID/IQ, contract for the design, development, testing and delivery of products in support of the FY21 Ready Relevant Learning, or RRL, Content Conversion program. Cubic said in a release, "The Cubic-led team will use innovative instructional systems design, systems engineering and training assessment approaches in conjunction with new and modernized technologies to support ratings-accession training while simultaneously supporting the broader Sailor 2025, or S2025, overarching goal of improving Sailors' transfer of training to the operational work environment. The FY21 RRL CC program falls under the 'Ready, Relevant Learning' pillar of S2025, which focuses on learning continuums where training is delivered by modern methods to enable faster learning, more effective knowledge retention and delivery for Sailors."
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DPZ | Hot Stocks07:19 EDT Domino's Pizza offers Carside Delivery carryout option - Domino's Pizza is offering customers another way to carry out their pizza via Domino's Carside Delivery. Domino's Carside Delivery is a new contactless carryout option that customers can choose when placing a prepaid online order, and it is now available in stores across the U.S. When customers place a prepaid digital carryout order, they'll see the option for Domino's Carside Delivery. Once they make that selection, they will be prompted to add their vehicle color, make and model, which will be used to identify them when they arrive at the store. Customers can also select where in the car they'd like their order placed.
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RESN | Hot Stocks07:18 EDT Resonant to join Russell 2000, 3000 Indexes - Resonant is set to join the small-cap Russell 2000 Index and broad-market Russell 3000 Index at the conclusion of the 2020 Russell indexes annual reconstitution. The Russell Index changes will be effective after the US market opens on June 29, 2020. The stock also was automatically added to the appropriate growth and value indexes.
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LH | Hot Stocks07:18 EDT LabCorp introduces Xcellerate COVID-19 clinical study solution - LabCorp announced that Covance, its drug development business, has deployed the Xcellerate COVID-19 solution as part of its award-winning Xcellerate platform. LabCorp said in a release, "Covance has developed a comprehensive approach to reinitiate ongoing research and start up new studies, with a focus on patient safety and study delivery. Designed in conjunction with Covance's COVID-19 Operational Recovery Team, the Xcellerate COVID-19 solution offers integrated data collection, actionable views of critical study data, COVID-19 targeted risk management and recovery assessment. Global clinical research has been disrupted by the COVID-19 pandemic. Specific impacts include studies being halted or paused and enrollment being delayed. Many clinical research sites around the world have restricted all but essential visits except for patient safety, with study monitoring conducted remotely where possible. As healthcare conditions improve globally, research sites are positioned to resume studies."
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MATN | Hot Stocks07:17 EDT Mateon Therapeutics announces $2M financing with Golden Mountain Partners - Mateon Therapeutics announces it has secured a $2 million in debt financing with Golden Mountain Partners for the conduct of a clinical trial evaluating OT-101 against COVID-19. This is a 1-year convertible note with 2% annual interest, personally guaranteed by Dr. Vuong Trieu, the Chief Executive Officer of Mateon. The note is convertible at the 1 year anniversary of the note, at the common stock price of the Company on conversion with no discount. GMP does not have the option to convert prior to the 1-year anniversary. Such financing will be utilized solely to fund the clinical trial. OT-101 is an antisense againt the host TGF-beta protein required for viral replication and its overexpression likely to cause the wide range of clinical symptoms associated with COVID-19 including Kawasaki syndrome and acute respiratory distress syndrome.
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OFIX | Hot Stocks07:17 EDT Orthofix announces FDA clearance of FIREBIRD SI Fusion System - Orthofix Medical announced the FDA 510(k) clearance and the first patient implants of the FIREBIRD SI Fusion System. Orthofix said in a release, "Designed to compress and stabilize the sacroiliac joint during fusion, the FIREBIRD SI Fusion System is the first 3D printed titanium bone screw to launch in the U.S. for treating SI joint dysfunction. The FIREBIRD SI Fusion System is designed with a porous mid-shaft region that allows bone to grow into its surface - creating a bond between the implant and the patient's bone at the SI joint. Featuring a cannulated screw design, the system enables the surgeon to pack the device with autograft and/or allografts like the Trinity ELITE Allograft with viable cells to help ensure bone fusion. The FIREBIRD SI screws are available in an assortment of lengths and diameters to address a variety of patient anatomies. This novel system is being launched in the U.S through a limited market release."
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ICPT | Hot Stocks07:16 EDT Intercept receives FDA CRL for obeticholic acid recommending additional data - Intercept Pharmaceuticals announced that the U.S. Food and Drug Administration has issued a Complete Response Letter regarding the New Drug Application for obeticholic acid for the treatment of fibrosis due to nonalcoholic steatohepatitis. The CRL indicated that, based on the data the FDA has reviewed to date, the Agency has determined that the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH. The FDA recommends that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the study should continue. Intercept had previously disclosed that, based on the FDA's decision to postpone a tentatively scheduled advisory committee meeting, it was expected that the Agency's review of its NDA would extend beyond the PDUFA goal date and that the FDA would move forward with rescheduling the Adcom. The NDA submission for OCA is the first for NASH and was based on data from 35 clinical trials and more than 1,700 NASH patients treated with the drug. OCA is the only investigational NASH drug with Breakthrough Therapy designation and has uniquely demonstrated reproducible ability to reverse or otherwise stabilize liver fibrosis in patients with advanced fibrosis due to NASH. According to the FDA draft guidance for NASH fibrosis, of the histologic features of NASH, fibrosis is considered the strongest predictor of adverse clinical outcomes, including liver-related death. There is currently no approved therapy for this devastating disease, which has become a leading cause of liver failure and resulting poor clinical outcomes.
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GILD | Hot Stocks07:16 EDT Gilead says remdesivir treatment to be priced at $2,340 per U.S. patient - Gilead CEO Daniel O'Day said in an open letter, "In the weeks since we learned of remdesivir's potential against COVID-19, one topic has attracted more speculation than any other: what price we might set for the medicine. This degree of speculation is understandable. Remdesivir, our investigational treatment, is the first antiviral to have demonstrated patient improvement in clinical trials for COVID-19 and there is no playbook for how to price a new medicine in a pandemic. We are aware of the significant responsibility that comes with pricing remdesivir, and the need to be transparent on our decision. After giving this the considerable care, time and amount of discussion that it merits, we are now ready to share our decision and explain how we reached it. As with all our actions on remdesivir, we approached this with the aim of helping as many patients as possible, as quickly as possible and in the most responsible way. This has been our compass point throughout, from collaborating to find rapid answers on safety and efficacy, to scaling up manufacturing and donating our supply of remdesivir through the end of June. In each case, we recognized the need to do things differently to reflect the exceptional circumstances of the pandemic. Now, as we transition beyond the donation period and set a price for remdesivir, the same principle applies. In normal circumstances, we would price a medicine according to the value it provides. The first results from the NIAID study in hospitalized patients with COVID-19 showed that remdesivir shortened time to recovery by an average of four days. Taking the example of the United States, earlier hospital discharge would result in hospital savings of approximately $12,000 per patient. Even just considering these immediate savings to the healthcare system alone, we can see the potential value that remdesivir provides. This is before we factor in the direct benefit to those patients who may have a shorter stay in the hospital. We have decided to price remdesivir well below this value. To ensure broad and equitable access at a time of urgent global need, we have set a price for governments of developed countries of $390 per vial. Based on current treatment patterns, the vast majority of patients are expected to receive a 5-day treatment course using 6 vials of remdesivir, which equates to $2,340 per patient. Part of the intent behind our decision was to remove the need for country by country negotiations on price. We discounted the price to a level that is affordable for developed countries with the lowest purchasing power. This price will be offered to all governments in developed countries around the world where remdesivir is approved or authorized for use. At the current price of $390 per vial, remdesivir is positioned to achieve the aim of providing immediate net savings for healthcare systems. In the U.S., the same government price of $390 per vial will apply. Because of the way the U.S. system is set up and the discounts that government healthcare programs expect, the price for U.S. private insurance companies, will be $520 per vial. At the level we have priced remdesivir and with government programs in place, along with additional Gilead assistance as needed, we believe all patients will have access. Gilead has entered into an agreement with the U.S. Department of Health and Human Services whereby HHS and states will continue to manage allocation to hospitals until the end of September. After this period, once supplies are less constrained, HHS will no longer manage allocation. In the developing world, where healthcare resources, infrastructure and economics are so different, we have entered into agreements with generic manufacturers to deliver treatment at a substantially lower cost. These alternative solutions are designed to ensure that all countries in the world can provide access to treatment. Our work on remdesivir is far from done. We continue to explore its potential to help in this pandemic in various ways, such as evaluating treatment earlier in the course of the disease, in outpatient settings, with an inhaled formulation, in additional patient groups and in combination with other therapies. As we accumulate more data from global clinical trials and initiate many additional studies, we will understand more about the full value of remdesivir over time. Our teams also remain focused on increasing supplies to meet the high global demand. By the end of this year, we expect our investment on the development and manufacture of remdesivir to exceed $1 billion and our commitment will continue through 2021 and beyond. In making our decision on how to price remdesivir, we considered the full scope of our responsibilities. We started with our immediate responsibility to ensure price is in no way a hindrance to ensuring rapid and broad treatment. We also balanced that with our longer-term responsibilities: to continue with our ongoing work on remdesivir, to maintain our long-term research in antivirals and to invest in scientific innovation that might help generations to come. As with many other aspects of this pandemic, we are in unchartered territory in pricing remdesivir. Ultimately, we were guided by the need to do things differently. As the world continues to reel from the human, social and economic impact of this pandemic, we believe that pricing remdesivir well below value is the right and responsible thing to do."
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ACB | Hot Stocks07:16 EDT Aurora Cannabis director, co-founder Terry Booth retires - Aurora Cannabis announced that co-founder Terry Booth has retired from his role as director of the company, effective immediately. Booth was the CEO of Aurora from December 2014 through February and served on Aurora's board since December 2014.
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APRE BMY | Hot Stocks07:14 EDT Aprea Therapeutics appoints Fouad Namouni, Richard Peters to board - Aprea Therapeutics (APRE) announced the appointments of Fouad Namouni, M.D. and Richard Peters, M.D., Ph.D. to its Board of Directors. In addition, Guido Magni, M.D., Ph.D. will step down from the Company's Board of Directors, effective June 30, 2020. Fouad Namouni most recently serving as Senior Vice President & Head of Oncology Development at Bristol-Myers Squibb (BMY). Richard Peters currently serves as President, Chief Executive Officer and Director at Yumanity Therapeutics.
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INSU | Hot Stocks07:13 EDT Insurance Acquisition to combine with Shift Technologies for $380M in stock - Shift Technologies and Insurance Acquisition announced they have entered into a definitive merger agreement whereby Shift will combine with Insurance Acquisition. In connection with the closing of the transaction, Insurance Acquisition intends to change its name to Shift Technologies and remain Nasdaq-listed under a new ticker symbol. The transaction is expected to close in Q3. Following the close of the transaction, Shift's management team will continue to operate the combined company. Insurance Acquisition will combine with Shift for aggregate consideration of approximately $380M in Insurance Acquisition Class A common stock, plus an additional 6M shares of Class A common stock that will be earned if the combined company achieves certain price targets over time. In connection with the transaction, institutional investors, including Fidelity Management & Research and ArrowMark Partners, have committed to a $185M private purchase of Insurance Acquisition Class A common stock that will close concurrently with the business combination. Insurance Acquisition has committed to register these private shares shortly following the closing of the combination. The combined company will retain up to $300M of cash following the transaction, which will be used to support working capital and fund growth. The boards of directors of both Insurance Acquisition Corp. and Shift unanimously approved the transaction. The proposed transaction is expected to be completed in the third quarter of 2020, pending stockholder approval of both Insurance Acquisition Corp. and Shift, and is subject to customary regulatory and other closing conditions.
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ULBI | Hot Stocks07:12 EDT Ultralife added to Russell 2000 Index - Ultralife Corporation announced it has been added to the Russell 2000 Index as part of the 2020 Russell U.S. Indexes annual reconstitution.
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GILD | Hot Stocks07:11 EDT Gilead says remdesivir treatment to be priced at $2,340 per U.S. patient
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TNXP | Hot Stocks07:11 EDT Tonix says enrollment in Phase 3 RELIEF trial 'ahead of schedule' - Tonix announced that due to faster-than-expected enrollment, the Company anticipates topline Phase 3 RELIEF results in the fourth quarter of 2020, rather than the first quarter of 2021 as previously guided. RELIEF is a potential pivotal study of TNX-102 SL 5.6 mg, a non-opioid, centrally acting analgesic, taken daily at bedtime for the management of fibromyalgia. An optional interim analysis of the first 50 percent of randomized participants that are evaluable for efficacy will be conducted, with results expected in September 2020. The RELIEF study is a double-blind, randomized, placebo-controlled adaptive design trial designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg in fibromyalgia. The trial is expected to enroll approximately 470 participants across approximately 40 U.S. sites. For the first two weeks of treatment, there is a run-in period in which participants start on TNX-102 SL 2.8 mg or placebo. After the first two weeks, all participants have the dose increased to TNX-102 SL 5.6 mg or two placebo tablets for 12 weeks. The primary endpoint is daily diary pain severity score change from baseline to Week 14, analyzed by mixed model repeated measures with multiple imputation.
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SLGL... | Hot Stocks07:10 EDT Sol-Gel signs agreements with Perrigo for three generic product candidates - Sol-Gel Technologies (SLGL) announced that it has entered into collaborative agreements with Perrigo Company (PRGO), for the development, manufacturing and commercialization of three new, generic product candidates. Consistent with Sol-Gel's prior agreements with Perrigo, Perrigo will seek regulatory approval with the U.S. Food and Drug Administration for these generic product candidates. If approved by the FDA, Perrigo will lead the commercialization efforts for the generic product candidates in the United States. Sol-Gel and Perrigo will share the development costs and any gross profits generated from potential sales of the generic product candidates. Separately, Sol-Gel notes that Bausch Health Companies (BHC) filed a patent infringement action regarding Perrigo's Abbreviated New Drug Application for a generic version of Bryhali lotion, 0.01%, for the treatment of plaque psoriasis in adults. The halobetasol propionate lotion, 0.01%, development is covered under a previous collaboration between Sol-Gel and Perrigo.
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ALT | Hot Stocks07:08 EDT Altimmune receives $4.7M award from DoD for Phase 1/2 trial of T-COVID - Altimmune announced it was awarded $4.7 million from the U.S. Army Medical Research & Development Command to fund its Phase 1/2 clinical trial of T-COVID, an investigational intranasal immune modulator for the treatment of outpatients with early COVID-19. The competitive award was granted by USAMRDC in collaboration with the Medical Technology Enterprise Consortium, a 501(c)(3) biomedical technology consortium working in partnership with the Department of Defense. The award is expected to provide Altimmune sufficient funding to cover the entire cost of conducting this clinical trial. As previously announced, patient enrollment in the T-COVID Phase 1/2 trial is expected to commence in the coming weeks, with data readout expected in the fourth quarter of 2020. If the Phase 1/2 clinical trial is successful, the Company plans to initiate a Phase 2/3 trial of T-COVID early next year and commence discussions regarding a potential Emergency Use Authorization. On June 1, Altimmune announced that the U.S. Food and Drug Administration authorized the Company to proceed with a clinical trial of T-COVID, which is based on the same technology supporting Altimmune's intranasal vaccine candidates, including AdCOVID for COVID-19, NasoShield for anthrax and NasoVAX for influenza. T-COVID is differentiated from most other COVID-19 therapeutics currently in development as it is focused on non-hospitalized patients prior to the development of pulmonary dysfunction with a goal to prevent the progression to severe lung inflammation and thereby decrease the development of severe COVID-19 and the need for hospitalization. The T-COVID therapeutic program complements the Company's novel single-dose COVID-19 vaccine candidate, AdCOVID, that utilizes the Company's proprietary intranasal vaccine technology and has the potential to prevent infection by activating multiple arms of the immune system. On May 13, Altimmune announced the initiation of AdCOVID preclinical studies at the University of Alabama at Birmingham. Multiple candidates of the AdCOVID vaccine are currently being evaluated at UAB, and the topline immunogenicity results are expected to identify the best vaccine candidate for manufacturing and clinical development. The Company intends to initiate manufacturing in July with the Phase 1 clinical trial expected to begin in Q4 of this year.
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GNMK | Hot Stocks07:06 EDT GenMark announces commercial launch of ePlex Respiratory Pathogen Panel 2 - GenMark Diagnostics announced that its ePlex Respiratory Pathogen 2 Panel is now available for U.S. commercial distribution and clinical use. The ePlex RP2 Panel is one of the first rapid-result multiplex panel tests that can identify 21 pathogens, including SARS-CoV-2, to be made available for clinical use. The company also submitted an Emergency Use Authorization to the U.S. Food and Drug Administration for the ePlex Respiratory Pathogen 2 Panel earlier this month. The ePlex RP2 Panel is designed to provide results for SARS-CoV-2 - the virus that causes COVID-19 - in addition to a number of other common respiratory pathogens, including influenza, adenovirus, rhinovirus and respiratory syncytial virus, in under two hours. The panel also includes a new, simplified workflow making it even easier for labs to run the test. The ability to quickly determine the cause of infections will be vital in the fall and winter when many of these respiratory pathogens are likely to be circulating, along with SARS-CoV-2. Incorporating the SARS-CoV-2 assay into the existing ePlex RP Panel is intended to streamline the diagnostic process for hospitals by allowing them to check for multiple pathogens with a single test, saving time and resources and improving bed management. A study at two acute large tertiary care hospitals demonstrated that using the ePlex RP panel in the Emergency Department led to earlier patient results which resulted in an 8.4% reduction in hospital admissions.
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AKCA AMAG | Hot Stocks07:06 EDT Akcea Therapeutics appoints Tracy Palmer Berns as CCO - Akcea Therapeutics (AKCA) announced that Tracy Palmer Berns has joined the company as chief compliance officer, or CCO. In this role, Berns will be responsible for the company's ongoing compliance program focusing on policy development and training. She will also collaborate with other members of the executive team to provide counsel related to development of business goals and compliance matters related to Akcea's commercial products and investigational therapies. Before Akcea, Berns served as vice president, CCO and legal affairs at Amag Pharmaceuticals (AMAG) where she was responsible for the company's compliance program and therapeutic product legal team and provided legal advice on regulatory, development, pharmacovigilance and quality matters.
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AQST | Hot Stocks07:05 EDT Aquestive Therapeutics files IND for PK trials of AQST-108 - Aquestive Therapeutics announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for pharmacokinetic clinical trials of its drug candidate AQST-108, a "first of its kind" oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis using Aquestive's proprietary PharmFilm technologies. The Company intends to initiate its planned PK trials before the year end 2020. Aquestive plans to initiate its PK clinical trials of AQST-108 in a crossover study to compare the pharmacokinetics and pharmacodynamics of epinephrine administered as sublingual film to that of epinephrine administered as an injection. As proposed by Aquestive and confirmed by the FDA at the pre-IND meeting held in February 2020, the clinical development for AQST-108 will be reviewed under the 505(b)(2) regulatory approval pathway. The FDA acknowledged that there appears to be an unmet medical need among patients who resist the standard of care use of subcutaneous and intramuscular injection in the treatment of anaphylaxis. The Company believes that AQST-108 may potentially address some of those unmet needs.
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APTO | Hot Stocks07:04 EDT Aptose receives FDA allowance of IND for Phase 1a/b study of CG-806 - Aptose Biosciences announced that the U.S. Food and Drug Administration completed its review of the company's Investigational New Drug application and has granted IND allowance for the initiation of a Phase 1a/b clinical study of CG-806, the company's highly potent, oral FLT3/BTK inhibitor, in patients with acute myeloid leukemia. CG-806 is currently in a Phase 1 dose escalation study in patients with B-cell malignancies, including chronic lymphocytic leukemia and non-Hodgkin's lymphomas, who have failed or are intolerant to current therapies. Aptose intends to initiate the Phase 1 a/b study in the second half of 2020 in AML patients who have relapsed, are resistant or refractory to current treatment.
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NEPT | Hot Stocks07:04 EDT Neptune Wellness receives cannabis sales license from Health Canada - Neptune Wellness announced it has been authorized by Health Canada to sell cannabis products to provinces and territories. This sales license includes edibles, vapes, extracts and topicals, including beverage products. This authorization adds to previously held processing license and will expand Neptune's cannabis operations to include proprietary branded products. Additionally, the authorization enhances the capabilities of the company's white label offerings, providing incremental value and service offerings to its B2B customers. In addition to the sales license, Neptune's cold storage and added operating space have been approved for operation. The enlarged cold storage and approved space in the Sherbooke facility provide greater capacity to process larger volumes of product and store at low temperature to protect product. The increased storage adds to Neptune's logistic capabilities and provides incremental solutions to the company's clients.
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NVO MRK | Hot Stocks07:03 EDT Novo Nordisk reports Rybelsus approved in Japan for treatment of type 2 diabetes - Novo Nordisk (NVO) announced that the Japanese Ministry of Health, Labour and Welfare has approved Rybelsus, which it calls "the first and only oral glucagon-like peptide-1 receptor agonist in a tablet," for the treatment of adults with type 2 diabetes. Novo Nordisk will now initiate reimbursement negotiations and expects to launch Rybelsus in Japan thereafter. Novo Nordisk and Merck (MRK), known as MSD outside the United States and Canada, will be co-promoting Rybelsus in Japan.
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LLEX | Hot Stocks07:02 EDT Lilis Energy voluntarily files for Chapter 11 Bankruptcy - Lilis Energy announced that it has filed petitions under Chapter 11 of the United States Bankruptcy Code to initiate voluntary cases in the United States Bankruptcy Court for the Southern District of Texas, Houston Division. The Chapter 11 petitions were filed in accordance with a Restructuring Support Agreement entered into among the Company and certain of its subsidiaries, certain investment funds and entities affiliated with Varde Partners, which collectively own all of the Company's outstanding preferred stock, a subordinated portion of the indebtedness outstanding under the Company's Second Amended and Restated Senior Secured Revolving Credit Agreement, a portion of the Company's common stock, and all other lenders under the Credit Agreement. Under the RSA, the Company and its subsidiaries, the RBL Lenders and the Varde Funds have agreed, subject to certain conditions set forth in the RSA, to support a restructuring of the Company and its subsidiaries under a Chapter 11 plan of reorganization to be proposed with terms set forth in the RSA. Such Plan, if consummated, is expected to reduce the Company's funded debt obligations by more than $34.9 million, and right-size the Company's bank indebtedness for future operations. The Plan contemplated by the RSA further provides that shares of the Company's common stock will be canceled for no consideration. The Company believes it is unlikely that the holders of shares of its common stock will receive any consideration for their shares under any plan approved by the Court, irrespective of whether such plan contemplates terms consistent with or similar to those agreed upon in the RSA. Consummation of any restructuring plan will be subject to confirmation by the Court and the satisfaction, or waiver by appropriate parties, of any conditions set forth in such plan and related transaction documents. The Company expects to continue to operate in the ordinary course throughout the restructuring process without material disruption to vendors, suppliers and partners. The Plan is contingent upon the Varde Funds' election to provide, on or before August 17, 2020, an agreed equity commitment and provision of additional debtor-in-possession financing. In the event the Varde Funds elect not to provide DIP financing and to make the equity investment in the Company or the Plan contemplated in the RSA is not otherwise pursued, the RSA provides that the Company will pursue an agreed sales process with respect to its assets. The RSA is also subject to termination by the RBL Lenders and the Varde Funds in the event certain milestones in the reorganization process are not met. With the filing, and subject to court approval, the Company has received a commitment from its bank lenders under its Credit Agreement to provide up to $15.0 million in DIP financing. The Company anticipates up to $5.0 million will be available on an interim basis. With the Company's usual operating cash flows, these financings are expected to provide sufficient liquidity for the Company to continue to operate in the ordinary course through the restructuring process. Vinson & Elkins L.L.P. is serving as legal advisor to the Company, Barclays Capital is serving as investment banker for the Company, and Opportune LLP is serving as restructuring advisor to the Company. On June 27, 2020, Markus Specks resigned as a director of the Company. Under their rights as holders of the Company's outstanding preferred stock, the Varde Funds named Mr. Nicholas Winter, a Managing Director of Varde Partners, Inc. as their new designated director, replacing Mr. Specks.
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BSX | Hot Stocks07:01 EDT Boston Scientific receives FDA clearance for LUX-Dx - Boston Scientific has received FDA 510(k) clearance for the LUX-Dx Insertable Cardiac Monitor, or ICM, System, a new, long-term diagnostic device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation, cryptogenic stroke and syncope. The company said in a release, "The new LUX-Dx ICM System is designed with a dual-stage algorithm that detects and then verifies potential arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making. Further, the remote programming capabilities of the device via the LATITUDE Clarity Data Management System website allow physicians and care teams to adjust event detection settings without requiring an in-person patient appointment, a feature unavailable on any other ICM currently on the market."
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WEX | Hot Stocks07:01 EDT Wex announces $400M investment from Warburg Pincus - WEX announced it has agreed to a $400M investment from an affiliate of Warburg Pincus LLC which includes convertible notes in an aggregate principal amount of $310M and $90M in common stock through a private placement. The Private Placement is subject to customary closing conditions and is expected to close in the next several days. Importantly, WEX has also obtained an amendment to its existing senior secured credit facilities, providing WEX with increased financial flexibility. The combination of the investment and the credit agreement amendment will strengthen WEX's financial profile and will enable the company to remain focused on its strategic initiatives as it navigates the global COVID-19 pandemic. "We are pleased to further fortify our balance sheet during the current uncertain operating environment while reaffirming our relationship with Warburg Pincus, who has demonstrated their strong commitment to the future growth of WEX," said Melissa Smith, WEX's Chair and CEO. Smith continued, "The combination of this investment and the recent credit agreement amendment put us in an even stronger financial position with additional financial flexibility, improved liquidity and increased cash on hand. This better positions us to remain focused on our long-term strategic initiatives to drive our future success, and capitalize on the economic recovery when market conditions improve."
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WEX | Hot Stocks07:00 EDT Wex announces $400M investment from Warburg Pincus - WEX announced it has agreed to a $400M dollar investment from an affiliate of Warburg Pincus LLC which includes convertible notes in an aggregate principal amount of $310M and $90M in common stock through a private placement. The Private Placement is subject to customary closing conditions and is expected to close in the next several days. Importantly, WEX has also obtained an amendment to its existing senior secured credit facilities, providing WEX with increased financial flexibility. The combination of the investment and the credit agreement amendment will strengthen WEX's financial profile and will enable the company to remain focused on its strategic initiatives as it navigates the global COVID-19 pandemic. "We are pleased to further fortify our balance sheet during the current uncertain operating environment while reaffirming our relationship with Warburg Pincus, who has demonstrated their strong commitment to the future growth of WEX," said Melissa Smith, WEX's Chair and CEO. Smith continued, "The combination of this investment and the recent credit agreement amendment put us in an even stronger financial position with additional financial flexibility, improved liquidity and increased cash on hand. This better positions us to remain focused on our long-term strategic initiatives to drive our future success, and capitalize on the economic recovery when market conditions improve."
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DSGX | Hot Stocks06:53 EDT Descartes Systems platform selected by DHL Aviation - Descartes Systems announced that Brussels-based DHL Aviation has selected Descartes' global air messaging gateway as its platform to standardize electronic messaging with its global customer base, including freight-forwarding organizations, other airlines, postal service operators and express courier companies, as well as ground handling agents, or GHAs. DHL will also deploy Descartes air shipment management, or ASM, and Descartes AEI, a solution to collect, prepare and submit the required advance electronic information for global air cargo security filings to a range of countries worldwide.
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COTY | Hot Stocks06:49 EDT Coty to acquire 20% ownership in Kim Kardashian West beauty business for $200M - Coty and Kim Kardashian West announced that they have entered into a strategic transaction to further develop Kardashian West's business globally. Together, Coty and Kardashian West will focus on entering new beauty categories and global expansion beyond her existing product lines. Kardashian West and her team will lead all creative efforts in terms of product and communications initiatives, building on her reach capabilities through social media. In January, Coty acquired a 51% stake in Kardashian West's half-sister Kylie Jenner's brands. Under the terms of the agreement, Coty will acquire a 20% ownership interest in Kardashian West's beauty business for $200M. Coty will have overall responsibility for the portfolio's development in skincare, haircare, personal care and nail products, leveraging its understanding of the industry and its commercial and go-to-market strategy. The acquisition is expected to close in Q3 of FY21. All the business's products will be sold through luxury beauty retailers as well as owned digital channels.
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PRTS | Hot Stocks06:23 EDT U.S. Auto Parts added to Russell 2000 Index
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FLR | Hot Stocks06:19 EDT Fluor segment divests EQIN business to VE Partners - Fluor announced that Stork, part of Fluor's diversified services segment, has come to an agreement with VE Partners to sell EQIN, Stork's professional equipment rental business in Europe. This intended divesture is pending final approval by the Dutch Authority for Consumers and Markets, or ACM. After final ACM approval, Stork and the new owner VE Partners, a Netherlands-based private equity firm, will proceed with a transfer of EQIN. The new company will continue to operate as EQIN.
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CYDY | Hot Stocks06:14 EDT CytoDyn, NIH of Mexico complete MOU to conduct small COVID-19 trial - CytoDyn announced the Company and the Coordinating Commission of the National Institutes of Health and High Specialty Hospitals of Mexico, or NIH, have entered into a Memorandum of Understanding, or MOU, to conduct a COVID-19 clinical trial with leronlimab for severe and critically ill patients, with the potential to collaborate on additional COVID-19 trials. The NIH of Mexico is an organization that coordinates the main institutions of medical care and public research in the country. The MOU provides CytoDyn will supply leronlimab at its expense to the NIH and both parties are proceeding forward expeditiously to complete the mutually agreed protocol for this clinical trial.
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SMHI CKH | Hot Stocks06:12 EDT SEACOR Marine expects to receive $28.2M from CARES Act carryback NOLs - SEACOR Marine (SMHI) announced that it expects to receive a net amount of approximately $28.2M of cash from tax refunds as a result of its ability to carryback net operating losses, or NOLs, under the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act. Approximately $23.7M of the CARES Act tax refunds are expected to be received within the next nine months, subject to the filing of the necessary tax refund claims and the refund schedule of the Internal Revenue Service. On June 26, SEACOR Marine entered into a Tax Refund and Indemnification Agreement, with its former parent company, Seacor (CKH), permitting the carry back by SEACOR Marine of net operating losses generated in 2018 and 2019 to tax years prior to SEACOR Marine's spin-off from Seacor in 2017. The agreement with Seacor does not restrict the use of approximately $16M of the refund with the remaining approximately $12.2M deposited into an account to be used solely to satisfy certain of SEACOR Marine's obligations that remain guaranteed by Seacor. These obligations primarily relate to scheduled monthly payments toward vessel operating leases, most of which will mature on or prior to December 2021. Under the terms of this agreement, SEACOR Marine will pay a one-time $3M transaction fee to SEACOR Holdings concurrently with the signing of the agreement as consideration for its cooperation in connection with the filing of tax refunds claims for tax years prior to the spin-off. The refund amounts listed above are after giving effect to this fee.
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TOUR | Hot Stocks06:12 EDT Tuniu regains compliance with Nasdaq - Tuniu announced that it received a notification letter from the Listing Qualifications Department of the Nasdaq Stock Market dated June 26, indicating that the Company has regained compliance with the Nasdaq Listing Rule 5450(a)(1) and the matter is closed.
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LCA | Hot Stocks06:11 EDT Landcadia to acquire Golden Nugget Online Gaming, GNOG to become public company - Tilman Fertitta and Landcadia announced that Landcadia II has entered into a Purchase Agreement to acquire Golden Nugget Online Gaming, or GNOG, a U.S. online real money casino owned by Tilman Fertitta. The parties said in a release, "Landcadia II is a publicly traded special purpose acquisition company co-sponsored by Fertitta Entertainment, Inc. and Jefferies Financial Group Inc. GNOG will become only the second pure publicly traded online casino company in the US. The transaction is expected to close in the third quarter of this year. Upon closing, Landcadia II intends to change its name to Golden Nugget Online Gaming, Inc. and its Nasdaq trading symbol to GNOG."
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NTCT ORCL | Hot Stocks06:06 EDT NetScout announces cloud collaboration with Oracle - NetScout (NTCT) announced that it is collaborating with Oracle (ORCL) to help customers gain end-to-end visibility for service assurance and security of mission-critical applications and services across their hybrid cloud infrastructures. NetScout is a gold level member of the Oracle PartnerNetwork, or OPN. NetScout's vStream and virtual nGeniusOne are now available from the Oracle Cloud Marketplace, offering Oracle Cloud customers application visibility and the ability to leverage information contained in application and network traffic for real-time telemetry. This enables I.T. teams to gain visibility and perform monitoring and troubleshooting of their critical services, regardless of the application or underlying infrastructure, with the ability to provide the forensics needed for responses. Deployable from Oracle Cloud Infrastructure, the nGeniusOne platform uses ISNG software, appliances, and vStream agents, to provide service assurance by identifying developing service delivery problems across any hybrid cloud environment. It analyzes network and application traffic to deliver end-to-end visibility into the availability and performance of applications, networks, service enablers and end-users.
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KBR | Hot Stocks06:03 EDT KBR awarded contract for solvent deasphalting technology by ANCAP - KBR's Solvent Deasphalting, or SDA, Technology, ROSE, has been selected by Uruguay's sole refinery, ANCAP, for a strategic upgrade project. KBR said in a release, "Under the terms of the contract, KBR will provide technology licensing, basic engineering design, and proprietary equipment for a 6,000 BPSD ROSE unit. The unit will allow ANCAP the operational flexibility for changing market conditions while supplying higher grade cleaner products and reducing its environmental footprint."
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CEO | Hot Stocks06:01 EDT CNOOC announces 'significant' discovery of Huizhou 26-6 - CNOOC announced that the Company made a significant discovery of Huizhou 26-6 in Eastern South China Sea. CNOOC said in a release, "It is expected to become the first mid-to-large sized condensate oil and gas field in the shallow water area of Pearl River Mouth Basin. The Huizhou 26-6 structure is located in Huizhou Sag in Zhu1 Depression of Pearl River Mouth Basin in Eastern South China Sea with an average water depth of about 113 meters. The discovery well HZ26-6-1 was drilled and completed at a depth of 4,276 meters and encountered oil and gas pay zones with a total thickness of approximately 422.2 meters. The well was tested to produce around 2,020 barrels of oil and 15.36 million cubic feet of gas respectively per day. The successful exploration of Huizhou 26-6 oil and gas structure is the first time that the Company has achieved commercial and highly productive oil and gas flow in buried hill exploration in Eastern South China Sea, marking a significant exploration breakthrough in Paleogene and buried hill complex oil and gas reservoir in Pearl River Mouth Basin, and further proving the huge exploration potential in this new field."
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FICO | Hot Stocks05:59 EDT FICO awarded 13 new patents related to fraud, AI, decision management - FICO announced that it has been awarded 13 new patents related to fraud, artificial intelligence, or AI, and decision management. In total, FICO currently holds 198 U.S. and foreign patents and 103 pending patent applications. FICO said in a release, "FICO now holds 198 US and foreign patents and currently has 103 pending patent applications."
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RIO | Hot Stocks05:57 EDT Rio Tinto reaches power supply deal with Mongolia for Oyu Tolgoi mine - Rio Tinto, Turquoise Hill and the Government of Mongolia have reached an agreement on the preferred domestic power solution for Oyu Tolgoi that paves the way for the Government to fund and construct a State Owned Power Plant at Tavan Tolgoi. The agreement, which is a revision of the Power Source Framework Agreement signed in 2018, states that the Parties will work towards finalizing a Power Purchase Agreement by the end of March 2021. In addition, the amended PSFA sets a proposed timetable for development, with construction of the coal-fired power plant set to begin no later than July 1, 2021, and commissioning within four years thereafter. Oyu Tolgoi currently uses imported power and both the Government of Mongolia and Oyu Tolgoi have committed to extending the current arrangement to ensure continued stable power is supplied to the mine and underground project until the State Owned Power Plant is commissioned and is able to supply stable, reliable and continuous power. Arnaud Soirat, Copper & Diamonds CEO, said, "This agreement provides a potential pathway to securing a domestic power supply for the Oyu Tolgoi mine and underground project for the benefit of all shareholders and the wider community. We look forward to working with the Government of Mongolia to progress the solution."
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INFO AMZN | Hot Stocks05:55 EDT IHS Markit selects AWS as preferred cloud infrastructure provider - Amazon Web Services, or AWS, an Amazon.com company (AMZN), announced that IHS Markit (INFO) has selected AWS as its preferred cloud infrastructure provider and is moving the majority of its data processing infrastructure, corporate platforms, and end user applications and services out of its data centers to AWS to accelerate innovation and improve resiliency. Under the new agreement, the company will migrate hundreds of additional applications over the next three years.
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CMCL | Hot Stocks05:49 EDT Caledonia Mining raises quarterly dividend to 8.5c per share - Mining Corporation announces that the board has declared a further increased quarterly dividend of 8.5c per share from 7.5c per share.
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KOS | Hot Stocks05:47 EDT Kosmos enters into crude oil prepayment agreement with Trafigura Trading - Kosmos Energy announced that it has entered into a crude oil prepayment agreement with Trafigura Trading. Kosmos said in a release, "The Prepayment Agreement provides up to $200 million of crude oil sales primarily related to a portion of the Company's 2022 and 2023 Gulf of Mexico production, with $150 million committed by Trafigura. Kosmos expects to execute $50 million of advance crude oil sales in June 2020. Later this year, following the completion of the Prepayment Agreement conditions subsequent, an additional $100-150 million of advance crude oil sales is expected, subject to finalizing additional commitments for $50 million. Kosmos is evaluating the classification of the Prepayment Agreement as deferred revenue on its balance sheet, although such accounting treatment is subject to final analysis."
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ALXN | Hot Stocks05:45 EDT Alexion announces EMA approval of ULTOMIRIS - Alexion Pharmaceuticals announced that the European Commission has approved ULTOMIRIS-the first and only long-acting C5 complement inhibitor administered every eight weeks-for the treatment of adults and children with a body weight of 10 kg or above with atypical hemolytic uremic syndrome, or aHUS, who are complement inhibitor treatment-naive or have received SOLIRIS for at least three months and have evidence of response to eculizumab. Alexion said in a release, "The European Commission approval is based on data from two global, single-arm open-label studies of ULTOMIRIS - one in adults and one in children, referred to as pediatrics in the study - with aHUS. Both studies are ongoing. A total of 18 out of 21 complement inhibitor treatment-naive children and 56 out of 58 complement inhibitor treatment-naive adults were enrolled and included in the interim analysis. The FDA approved ULTOMIRIS for the treatment of aHUS to inhibit TMA for adult and pediatric (one month of age and older) patients in October 2019."
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BP | Hot Stocks05:43 EDT BP sells petrochemicals business to Ineos for total of $5B - BP announced that it has agreed to sell its petrochemicals business to Ineos for a total consideration of $5B, subject to customary adjustments. Under the terms of the agreement, Ineos will pay BP a deposit of $400M and will pay a further $3.6B on completion. An additional $1B will be deferred and paid in three separate instalments of $100M in March, April and May 2021 with the remaining $700M payable by the end of June 2021. Subject to regulatory and other approvals, the transaction is expected to complete by the end of 2020. Bernard Looney, BP CEO said: "This is another significant step as we steadily work to reinvent bp. These businesses are leaders in their sectors, with world-class technologies, plants and people. In recent years they have improved performance to produce highly competitive returns and now have the potential for growth and expansion into the circular economy." The agreement means that BP has now agreed $15B of divestments and other disposals through 2019 and 2020 to date, an amount originally expected to be reached by mid-2021.
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RCEL | Hot Stocks05:42 EDT AVITA Medical implements scheme to redomicile to U.S. from Australia - AVITA Medical announced that the scheme of arrangement to effect the redomiciliation of the Company and its subsidiaries from Australia to the United States of America has been implemented. AVITA said in a release, "As previously announced, the Scheme was approved by the Company's shareholders at the Scheme meeting held via live webcast on 15 June 2020 and approved by the Federal Court of Australia on June 22. In accordance with the Scheme, all ordinary shares in the Company have today been transferred to AVITA Therapeutics, Inc. (Avita US), a company incorporated in the State of Delaware in the United States of America. Avita US is now the sole shareholder in the Company and the ultimate parent company of the Avita Group."
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BNR | Hot Stocks05:40 EDT Burning Rock Biotech announces strategic partnership with CStone Pharmaceuticals - Burning Rock Biotech announced a strategic partnership with CStone Pharmaceuticals to co-develop and commercialize companion diagnostics, or CDx, for pralsetinib, an investigational treatment developed by CStone's partner Blueprint Medicines, in China for the detection of RET alterations in cancer patients. "In an era of rapid development of precision medicines, CDx is of great significance to accurately identify the patient populations who could benefit from specific therapies. Burning Rock will continue to develop CDx-related products based on advanced next generation sequencing, or NGS, technology, and work with partners to promote the clinical application of precision diagnostics and treatment, potentially bringing clinical benefits to more patients," said Dr. Hao Liu, Chief Medical Officer at Burning Rock. "CStone is an excellent company focusing on innovative immuno-oncology and precision medicine programs. CStone's partner Blueprint Medicines released promising global data for pralsetinib this June at ASCO 2020. Burning Rock's close cooperation with CStone is expected to promote the standardization of RET gene testing in China."
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KKR | Hot Stocks05:13 EDT KKR acquires stake in First Gen through voluntary tender offer - KKR announced that, following the completion of the voluntary tender offer period by Valorous Asia Holdings, an entity owned by KKR investment funds, the Offeror has accepted all of the 427,041,291 common shares of First Gen Corporation that were tendered by shareholders at the close of the tender offer, representing approximately 11.9% of First Gen's outstanding common shares. KKR said in a release, "The Offeror intends to acquire all of these tendered common shares at a price of 45c per common share on July 1, the cross date previously set out in the Offeror's tender documents, representing a total investment value of $192.2M. First Gen is one of the Philippines' largest independent power producers and is a subsidiary of First Philippine Holdings Corporation. First Philippine Holdings is controlled by the Lopez family and is one of the most established conglomerates in the Philippines. The Company primarily generates power through renewable energy and indigenous fuel sources such as natural gas, geothermal energy from steam, hydro-electric, wind, and solar power. First Gen has 3,492 megawatts of installed capacity in its portfolio, which accounted for 21% of the Philippines' gross power generation in 2019. KKR makes its investment from its Asia Pacific infrastructure strategy."
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