Stockwinners Market Radar for June 03, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
ASGN | Hot Stocks20:05 EDT ASGN announces $250M stock buyback - ASGN announced that its board approved a stock repurchase program under which the Company may repurchase up to $250M of its common stock over the next two years.
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LMT | Hot Stocks19:53 EDT State Dept. approves possible Lockheed Martin sales of $1.67B to Bulgaria - The State Department has made a determination approving a possible Foreign Military Sale to the government of Bulgaria of F-16C/D Block 70/72 aircraft with support for an estimated cost of $1.673B. The Defense Security Cooperation Agency delivered the required certification notifying Congress of this possible sale on May 30, 2019. The prime contractor will be Lockheed Corporation. Reference Link
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AAL QUBSF | Hot Stocks19:40 EDT American Airlines confirms DOT tentative approval of Qantas partnership - American Airlines (AAL) and Qantas (QUBSF) welcome the U.S. Department of Transportation's tentative approval of the carriers' joint business to better serve customers flying between the United States and Australia and New Zealand. American and Qantas will review the Order, with a final decision from the DOT expected in the next few weeks. As part of the case put to the DOT, Qantas and American flagged an intention to launch several new routes within the first two years of the proposed joint business. Qantas expects to announce details of two new routes - Brisbane, Australia to Chicago and to San Francisco - once final approval is received.
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APPS... | Hot Stocks18:51 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: Digital Turbine (APPS) up 7.3%... Coupa Software (COUP) up 4.4%... Caleres (CAL) up 1.1%... ALSO HIGHER: Continental Resources (CLR) up 3.1% after announcing $1B buyback... Netlix (NFLX) up 0.5% after being upgraded to Buy at Loop Capital... DOWN AFTER EARNINGS: Box (BOX) down 13.0%... ALSO LOWER: Sientra (SIEN) down 7.0% after equity offering... i3 Verticals (IIIV) down 2.7% after equity offering... Ventas (VTR) down 2.0% after equity offering... Movers as of 18:30ET.
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BCO | Hot Stocks18:45 EDT Brink's CEO: We are well positioned to serve the cannabis industry - In an interview on CNBC's Mad Money, Brink's CEO Doug Pertz said: We are going to rename Dunbar trucks as Brinks... We think there is a whole range of customers who are not using our services... Our combined industry serves less than 10% of retail locations... There is still a large retail industry that continues to grow... We provide services on a local basis... On a global basis, cannabis is going to create a huge opportunity.
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WING | Hot Stocks18:23 EDT Wingstop CEO: We are just getting started, there is room to grow - In an interview on CNBC's Mad Money, Wingstop CEO Charlie Morrison said: We have a ton of space for growth... We think the U.S. and international footprint can be equal... We're not a bar... We have an efficient business model... We really don't have a true competitor... Social media is helping to drive comp sales... In our brand, we're pretty well insulated from labor costs.
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CE | Hot Stocks18:03 EDT Celanese to raise China acetyl intermediate product prices by RMB600/MT - Celanese will increase list and off-list selling prices for Acetic Acid and Acetic Anhydride products by RMB600 per MT. The price increases are for orders shipped and will be effective immediately, or as contracts otherwise allow, and are incremental to any previously announced increases.
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MAXR | Hot Stocks18:01 EDT Maxar Technologies awarded contract with National Reconnaissance Office - Maxar Technologies announced that it has been awarded a study contract with the National Reconnaissance Office that will enable the U.S. Government to gain a greater understanding of Maxar's current and future commercial imagery capabilities. The one-year contract will support the NRO's efforts to further research and assess the U.S. commercial electro-optical imagery industrial base's ability to task, collect, process and deliver satellite imagery.
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HTH | Hot Stocks17:44 EDT Hilltop Holdings' Feinberg sells 40,000 common shares - In a regulatory filing, Hilltop Holdings's Hill A. Feinberg, chairman of Hilltop Securities, disclosed the sale of 40,000 common shares of the company at a price of $20.2564 per share.
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MPWR | Hot Stocks17:39 EDT Monolithic Power director sells 10K shares of common stock - In a regulatory filing, Monolithic Power disclosed that its director James Moyer sold 10K shares of common stock on May 30th. The total transaction size was $1.18M.
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GALT | Hot Stocks17:33 EDT Galectin Therapeutics director Uihlein bought 4.7M share of common stock - In a regulatory filing, Galectin Therapeutics disclosed that its director Richard Uihlein bought 4.7M shares of common stock on May 31st. The total transaction size was $20.0M.
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GLD | Hot Stocks17:28 EDT SPDR Gold Shares holdings rise to 759.65MT from 743.21MT - This is the highest level of holdings since April 8th.
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SRI | Hot Stocks17:27 EDT Stoneridge appoints Susan Benedict as Chief Human Resources Officer - Stoneridge announced Susan Benedict as its new Chief Human Resources Officer and assistant general counsel - labor and employment. Benedict joined Stoneridge in November 2017 as director of legal, with primary responsibility for global labor and employment and legal compliance matters.
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LH | Hot Stocks17:27 EDT LabCorp announces new term loan facility - LabCorp entered into a new Term Loan Credit Agreement, which provides for a two-year term loan credit facility in the principal amount of $850M. Bank of America, N.A. is acting as administrative agent for a group of financial institutions providing the New Term Loan Facility. The proceeds from the borrowings under the New Term Loan Facility will be used for general corporate purposes, including to repay other indebtedness and in connection with the previously announced acquisition of the nonclinical research services business of Envigo International Holdings. The entire $850M principal amount of the New Term Loan Facility was advanced on June 3, with approximately $250M of the proceeds being applied to repay a portion of amounts outstanding under LabCorp's prior term loan credit facility entered into on September 15, 2017.
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BOX | Hot Stocks17:24 EDT Box says cloud content management is a $40B+ market opportunity - Says add-on product revenue grew by 57% in Q1. Says businesses need to operate faster than ever. Says saw 90% of deals including at least one add-on product. Says risk of cyber threats and regulations are growing. Says experienced strong customer retention. Says saw continued strength in Japan. Comments taken from Q1 earnings conference call.
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BMS... | Hot Stocks17:22 EDT S&P announces changes to S&P 400, 500 indices - Bemis (BMS) will replace Mattel (MAT) in the S&P 500, and Mattel will replace Bemis in the S&P MidCap 400 effective prior to the open of trading on Friday, June 7. Amcor (AMCRY) is merging with Bemis in a transaction expected to be completed soon pending final conditions. The combined company will be considered U.S. domiciled for index purposes, and Bemis will be treated as the surviving entity. Post merger, the company will be named Amcor plc and will trade on the New York Stock Exchange under ticker symbol "AMCR". Amcor plc will have a projected total market capitalization that is more representative of the large-cap market space. Mattel is ranked near the bottom of the S&P 500 and has a total market capitalization that is more representative of the mid-cap market space.
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CNR | Hot Stocks17:21 EDT Cornerstone Building Brands director Daniel Janki purchases 50K shares of stock - Cornerstone Building Brands director Daniel Janki disclosed in a regulatory filing that he had purchased 50,000 shares of company stock at an average price of $4.60 per share.The total transaction value of the purchase was $230,000.
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MAT BMS | Hot Stocks17:19 EDT Mattel to replace Bemis in S&P 400 at open on 6/7
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BMS... | Hot Stocks17:18 EDT Bemis to replace Mattel in S&P 500 at open on 6/7 - Amcor Limited (AMCRY) is merging with Bemis (BMS) in a transaction expected to be completed soon pending final conditions. The combined company will be considered US domiciled for index purposes, and Bemis will be treated as the surviving entity. Post merger, the company will be named Amcor plc and will trade on the New York Stock Exchange under ticker symbol "AMCR".
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IO | Hot Stocks17:17 EDT ION Geophysical chairman bought 60K shares of common stock - In a regulatory filing, ION Geophysical disclosed that its chairman James Lapeyre bought 60K shares of common stock on May 31st. The total transaction size was $407K.
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AAPL... | Hot Stocks17:12 EDT House panel chairman announces probe into competition in digital markets - House Antitrust Subcommittee Chairman David N. Cicilline announced a bipartisan investigation into competition in digital markets. The investigation will include a series of hearings held by the Subcommittee on Antitrust, Commercial and Administrative Law on the rise of market power online, as well as requests for information that are relevant to the investigation. "The growth of monopoly power across our economy is one of the most pressing economic and political challenges we face today. Market power in digital markets presents a whole new set of dangers," said Antitrust Subcommittee Chairman David N. Cicilline. "After four decades of weak antitrust enforcement and judicial hostility to antitrust cases, it is critical that Congress step in to determine whether existing laws are adequate to tackle abusive conduct by platform gatekeepers or whether we need new legislation to respond to this challenge." The Committee's investigation will focus on three main areas: Documenting competition problems in digital markets; Examining whether dominant firms are engaging in anti-competitive conduct; and assessing whether existing antitrust laws, competition policies, and current enforcement levels are adequate to address these issues. "Big Tech plays a huge role in our economy and our world," said Ranking Member Collins. "As tech has expanded its market share, more and more questions have arisen about whether the market remains competitive. Our bipartisan look at competition in the digital markets gives us the chance to answer these questions and, if necessary, to take action. I appreciate the partnership of Chairman Nadler, Subcommittee Chairman Cicilline and Subcommittee Ranking Member Sensenbrenner on these important issues." Companies that are reportedly to be investigated over antitrust concerns include Apple (AAPL), Facebook (FB), Google (GOOG), and Amazon (AMZN). Reference Link
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AZN MRK | Hot Stocks16:57 EDT AstraZeneca, Merck present full Phase 3 SOLO3 trial results at ASCO - AstraZeneca (AZN) and Merck (MRK) presented full results from the Phase 3 SOLO3 trial which compared Lynparza with physician's choice of chemotherapy in the treatment of patients with germline BRCA1/2-mutated, or gBRCAm, advanced ovarian cancer who had received two or more prior lines of chemotherapy. The results from the trial, presented at the American Society of Clinical Oncology, or ASCO, showed a statistically-significant and clinically-meaningful improvement in objective response rate, or ORR, for Lynparza vs. chemotherapy. ORR measures the proportion of patients with reduction in tumour burden of a predefined percentage. The trial also met the secondary endpoint of progression-free survival, or PFS, demonstrating a statistically-significant and clinically-meaningful improvement in the time patients lived without disease progression for Lynparza vs. chemotherapy. The safety and tolerability profile of Lynparza in the SOLO3 trial was consistent with previous trials. The most common adverse events, or AEs, greater than or equal to 20% were nausea, fatigue/asthenia, anaemia, vomiting, diarrhoea, neutropenia and abdominal pain. The most common greater than or equal to Grade 3 AEs were anaemia, neutropenia, fatigue/asthenia and thrombocytopenia. AEs led to dose interruption in 48% of patients on Lynparza while 7% of patients discontinued treatment. Lynparza, which is being jointly developed and commercialised by AstraZeneca and Merck, is approved for multiple indications in advanced ovarian cancer and metastatic breast cancer and has been used in over 20,000 patients worldwide. SOLO3 was a Phase III randomised, open-label, controlled, multicentre trial to evaluate the efficacy and safety of Lynparza tablets following two or more prior lines of chemotherapy. The trial randomised 266 patients with a deleterious or suspected deleterious BRCA1 or BRCA2 mutation. Eligible patients were randomised to receive Lynparza 300mg tablets twice daily or physician's choice of single-agent chemotherapy. The primary endpoint was ORR by blinded independent central review and key secondary endpoints included PFS, time to second disease progression or death and overall survival. The SOLO3 trial addresses a post-approval commitment from the December 2014 accelerated U.S. approval of Lynparza in ovarian cancer.
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MRK | Hot Stocks16:56 EDT Merck confirms FDA approval of Zerbaxa indication - Merck announced that the U.S. Food and Drug Administration has approved Merck's supplemental New Drug Application for the use of ZERBAXA for the treatment of patients 18 years and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Serratia marcescens. The sNDA for ZERBAXA had previously been designated Priority Review status by the FDA. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This expanded use is based on results of the pivotal Phase 3 ASPECT-NP trial that compared ZERBAXA 3g intravenously every 8 hours to meropenem for 8 to 14 days for the treatment of adult patients with HABP/VABP. "We are grateful to all of the patients who participated in the studies which led to the approval of ZERBAXA for the treatment of HABP/VABP," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "This approval reflects Merck's longstanding commitment to helping alleviate the burden of infectious diseases, including serious infections caused by Gram-negative pathogens."
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CVNA | Hot Stocks16:54 EDT Tiger Global Management reports 5.5% passive stake in Carvana - Tiger Global Management disclosed a 5.5% stake in Carvana, which represents over 2.68M shares. The filing does not allow for activism.
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LH | Hot Stocks16:49 EDT LabCorp and Envigo complete previously announced transactions - LabCorp and Envigo announced that they have completed previously announced transactions that will strengthen and enhance the way their respective businesses support research in the biopharmaceutical and life sciences industries. LabCorp's Covance Drug Development segment has completed the acquisition of Envigo's nonclinical contract research services business, expanding Covance's global nonclinical drug development capabilities with additional locations and resources. Envigo's Research Models and Services business has completed the acquisition of the Covance Research Products business, resulting in an organization dedicated to offering a full range of research models, diets and bedding. The two companies will continue to collaborate through a multi-year, renewable supply agreement. "This unique transaction furthers a key element of our strategy to provide the biopharma industry with comprehensive drug development services that help bring innovative medicines to patients," said David P. King, chairman and CEO of LabCorp. "We are delighted to welcome our new colleagues from Envigo to Covance and look forward to driving growth and innovation with enhanced nonclinical research solutions that ultimately improve health and improve lives."
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ELY | Hot Stocks16:34 EDT Callaway's Tokyo unit acquires remaining 48% stake in Callaway Apparel K.K. - Callaway Golf Company announced that its Tokyo-based subsidiary, Callaway Golf K.K., acquired the remaining 48% stake in Callaway Apparel K.K., an apparel joint venture between Callaway and its long-time partner, TSI Groove & Sports Co, Ltd. Effective June 1st, Callaway Golf K.K. owns 100% of Callaway Apparel K.K., which designs, manufactures and sells Callaway branded apparel, footwear, and headwear in Japan. Callaway Golf K.K. acquired the 48% minority interest for JPY2B, or approximately $18M based upon a 109 US Dollar to Yen exchange rate. This purchase price values Callaway Golf K.K. at approximately 9 times 2019 projected EBITDA. The joint venture began operations on July 1st, 2016 with its headquarters in Tokyo, Japan. Callaway owned 52% of the joint venture and TSI Groove & Sports Co, Ltd. owned 48%. TSI had previously partnered with Callaway as a licensee, helping to successfully launch and grow that business since 2002. Callaway Golf Company reported that this transaction would not affect the company's prior financial guidance for 2019.
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ACM MSG | Hot Stocks16:33 EDT Aecom selected as general contractor by MSG Sphere at the Venetian - The Madison Square Garden Company (MSG) announced that it has engaged AECOM (ACM) to serve as general contractor for MSG Sphere at The Venetian, MSG's state-of-the-art entertainment venue currently under construction in Las Vegas.
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DAC | Hot Stocks16:32 EDT Danaos regains compliance with NYSE - Danaos announced that the New York Stock Exchange, or NYSE, has notified the company that it is has regained full compliance with NYSE minimum average share price listing requirements. Danaos received written notification from the NYSE that it has regained compliance after the company's average stock price for the 30-trading days ended May 31 was above the NYSE's minimum requirement of $1.00. The company, which has continued to trade on the NYSE, is now in compliance with all NYSE listing requirements.
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BR | Hot Stocks16:31 EDT Broadridge names Samir Pandiri as President of Broadridge International - Broadridge Financial Solution announced the appointment of Samir Pandiri as President of Broadridge International. Most recently, Pandiri was Global CEO of BNY's Asset Servicing Division and a member of BNY Mellon's senior leadership team.
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ATKR | Hot Stocks16:31 EDT Atkore acquires United Structural Products, terms not disclosed - Atkore International Group announced that it has acquired the assets of United Structural Products, LLC, a manufacturer of welded aluminum and engineered-to-order cable trays that are built per NEMA standards and certified by Underwriters Laboratories. USP co-owner Dana Black and co-owner Tom Meredith will remain with the company in leadership roles as they support Atkore organization's continued focus on serving electrical products customers. USP is headquartered in Atlanta, Georgia and will continue operating at their current location under their flagship brand of US Tray. Terms of the sale are undisclosed.
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ACN | Hot Stocks16:29 EDT Accenture acquires BRIDGE Energy Group, terms not disclosed - Accenture has acquired BRIDGE Energy Group, a Boston-based consulting and systems integration firm that provides grid modernization, analytics and security services to utilities in North America. Terms of the transaction were not disclosed. BRIDGE's employees have joined the utilities practice of Accenture's Resources operating group.
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COUP | Hot Stocks16:23 EDT Coupa Software up 5.4% to $108.00 after Q1 results beat estimates - The company provided mixed guidance for Q2, but the midpoint of its FY20 outlook topped estimates.
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CAL | Hot Stocks16:22 EDT Caleres down over 3% at $18.80 per share after cutting FY19 EPS outlook
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MRK AZN | Hot Stocks16:20 EDT Merck's Lynparza study demonstrated 72% ORR in Phase 3 Solo3 trial - AstraZeneca (AZN) and Merck (MRK) presented full results from the Phase 3 SOLO3 trial which evaluated LYNPARZA, compared to chemotherapy, for the treatment of platinum-sensitive relapsed patients with germline BRCA1/2-mutated advanced ovarian cancer, who have received two more prior lines of chemotherapy. The results were presented at the 55th ASCO in Chicago. The results from the trial showed a "statistically-significant and clinically-meaningful improvement in objective response rate, or ORR, in the LYNPARZA arm compared to the chemotherapy arm, with ORR of 72.2% for LYNPARZA vs 51.4% for chemotherapy. The key secondary endpoint of progression-free survival was also significantly increased in the LYNPARZA arm at 13.4 months compared to the chemotherapy arm of 9.2 months. The safety and tolerability profile of LYNPARZA in SOLO3 was consistent with previous trials.
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WPC EXR | Hot Stocks16:19 EDT W.P. Carey, Extra Space Storage announce self-storage net lease transaction - W. P. Carey (WPC) and Extra Space Storage (EXR) jointly announced that they have entered into net lease agreements for 36 self-storage properties owned by W. P. Carey. The properties will be triple-net leased by Extra Space Storage for a period of 25 years. The leases include termination rights for both companies on the 10- and 20-year anniversaries, based on certain performance metrics. Commencing on the three-year anniversary, W. P. Carey also has the right to terminate the leases in the event of a sale, with Extra Space Storage retaining the right of first offer to acquire the properties. Rent generally commences by August 2019 and increases annually by a fixed percentage plus a percentage of revenue growth. The transaction includes a large majority of the self-storage properties that W. P. Carey acquired in its merger with CPA:17, representing approximately 90% of its total operating self-storage net operating income.
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ACN | Hot Stocks16:19 EDT Accenture names Joel Unruch chief compliance officer - Accenture has appointed Joel Unruch as general counsel, secretary and chief compliance officer. He succeeds Chad Jerdee, who is taking on a newly created role to lead Accenture's global strategy and programs focused on responsible business, corporate sustainability and citizenship. These changes are effective September 1, 2019. Unruch is currently senior managing director - deputy general counsel and corporate secretary, with responsibility for Accenture's corporate governance activities, working closely with its board of directors.
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CLR | Hot Stocks16:19 EDT Continental Resources announces initial $1B share repurchase program - Continental Resources announced that its Board of Directors approved the initiation of a quarterly dividend of 5c per share 20c per share annualized on the company's common stock and an initial $1B share-repurchase program. Continental maintains its 2019 guidance as announced on February 13, reaffirming the company's commitment to its corporate objectives and a strong alignment with shareholders. "Today marks another milestone in Continental's history as we initiate a total shareholder return strategy," said Harold Hamm, Chairman and Chief Executive Officer. "Our disciplined approach to balancing capital-efficient growth and reducing debt has enabled us to approve both an initial $0.20 per share annualized dividend and an initial $1B share-repurchase program. This demonstrates the confidence we have in the quality and sustainability of our assets and our commitment to maximizing shareholder value. We see the current value of our equity as being unreasonably low, making the acquisition of our stock the best use of excess cash at this time."
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AVB | Hot Stocks16:18 EDT AvalonBay provides Q2 operating update - AvalonBay Communities announced that total rental revenue for Established Communities for the two months ended May 31, 2019 increased 3.4% over the prior year period. This is 40 basis points above what the company's expectation was for total rental revenue growth during this period when the company published its outlook for full year Established Communities rental revenue growth on February 4, 2019. Renewal Offers for June and July 2019 are being delivered to residents at an average increase of 5.3% over the existing lease.
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GMS | Hot Stocks16:17 EDT GMS acquires acoustical, drywall operations of J.P. Hart Lumber Company - GMS Inc. announced that it has acquired the acoustical and drywall operations of J.P. Hart Lumber Company in San Antonio, TX. Hart Acoustical & Drywall Supply distributes drywall, metal studs, insulation and ceiling tiles through two locations in San Antonio, TX and one location in La Feria, TX. HADS will become part of GMS subsidiary, Lone Star Materials, Inc. The acquisition of HADS will enhance Lone Star's existing South Texas distribution network, which includes legacy locations in San Antonio, TX, Austin, TX and Laredo, TX. Post-closing, the HADS operations will transition to the Lone Star brand.
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EW | Hot Stocks16:16 EDT Edwards Lifesciences urges holders to reject 'mini-tender offer' by TRC Capital - Edwards Lifesciences Corporation announced that it has received notice of an unsolicited "mini-tender offer" by TRC Capital Corporation to purchase up to 1,000,000 shares, or approximately 0.48 percent of the company's outstanding shares of common stock as of the date of the offer. Edwards said it does not endorse this unsolicited offer and recommends that the company's stockholders reject the offer, either by doing nothing in response or by withdrawing their shares from the offer, if they have responded. Edwards is not affiliated or associated in any way with TRC Capital, its mini-tender offer or the offer documentation. The Securities and Exchange Commission has cautioned investors about these offers. TRC Capital's offer price is fixed at $162.38, which is lower than the current price of Edwards' shares as of today's close. Accordingly, Edwards urges stockholders to obtain current market quotations for their shares, review the conditions to the offer or consult with their broker or financial adviser before any decision regarding the offer is considered by our stockholders.
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GSM | Hot Stocks16:15 EDT Ferroglobe in pact to sell unit FerroAtlantica to TPG Sixth Street Partners - Ferroglobe announced that it has reached definitive agreement for the sale of its 100% interest in subsidiary FerroAtlantica to investment vehicles affiliated with TPG Sixth Street Partners ,the global finance and investment firm, for a total transaction value of 170M euros. The final price is subject to customary adjustments in this type of transaction, including net debt and working capital adjustments.The assets owned by FerroAtlantica to be transferred in this transaction are ten hydroelectric power plants with a combined generating capacity of approximately 167 MW, and the Cee-Dumbria ferroalloys factory, all located in the province of A Coruna ,Spain.
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IGLD | Hot Stocks16:14 EDT Internet Gold receives noncompliance notice from Nasdaq - Internet Gold reported that it received a notice from the Listing Qualifications Department of Nasdaq advising the company that it is not in compliance with Rule 5450 requiring maintenance of a minimum market value of publicly held shares, or MVPHS, of $5M. The company has a 180 days' period, until December 2, to regain compliance with the $5M MVPHS. If the MVPHS closes at $5M or more for a minimum of ten consecutive business days, the company will regain of compliance and the matter will be closed. In the event the company does not regain compliance with the rule prior to the expiration of the compliance period, it will receive written notification that its securities are subject to delisting. Alternatively, the company may apply to transfer the company's securities to the Nasdaq Capital Market, subject to meeting the Nasdaq Capital Market's continued listing requirements.
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ACHV | Hot Stocks16:13 EDT Achieve Life Sciences receives $4.2M from exercise of warrants - Achieve Life Sciences announced that it entered into an agreement with a single investor to exercise outstanding warrants that will provide an aggregate of $4.2M in total proceeds. The proceeds from the warrant exercise would bring Achieve's pro-forma cash balance to approximately $13.9M as of March 31, based on its most recently reported financial results. Pursuant to the agreement, the investor agreed to exercise outstanding warrants to purchase 270,313 shares of the company's common stock, with an exercise price of $3.1445 per share and outstanding warrants to purchase 837,500 shares of Common Stock with an exercise price of $4.00 per share. In exchange for the warrant exercise, Achieve has agreed to issue the investor a new warrant, exercisable for six years, to purchase up to 1,200,000 shares of Common Stock at an exercise price of $4.50 per share. The company also agreed to file a registration statement covering the resale of the shares issuable upon exercise of the new warrant.
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MATX | Hot Stocks16:12 EDT Matson says on schedule to meet IMO 2020 emission regulation - Matson has begun the installation of state-of-the-art exhaust gas cleaning systems on six vessels deployed in its Hawaii and China-Long Beach Express services as part of its strategy to reduce fleet emissions in line with new worldwide regulations established by the International Maritime Organization that take effect on January 1, 2020. Three of the vessels will receive the new equipment in 2019 and the remaining three in 2020. While new low-sulfur fuels designed to meet the new IMO emission standard have been in development for years in anticipation of the change, there is still uncertainty about their costs and availability. Liquefied Natural Gas is an alternative, but the infrastructure for production and distribution remains insufficient to support Matson's operations in the Pacific. With the deployment of dual-fuel engines in new ships and scrubbers in additional vessels, Matson will be able to meet or exceed the IMO 2020 emission standard while mitigating the expected higher cost of low-sulfur fuel over more than half of its current fleet.
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CAL | Hot Stocks16:12 EDT Caleres reports Q1 Famous Footwear SSS down 1.0%
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BOX | Hot Stocks16:10 EDT Box slips 4.4% after reporting Q1 results, cutting FY20 revenue guidance
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SRRK | Hot Stocks16:10 EDT Scholar Rock announces final top-line results from Phase 1 SRK-015 trial - Scholar Rock announced final top-line results from the Phase 1 clinical trial of its product candidate, SRK-015, a highly specific inhibitor of myostatin activation, in healthy adult volunteers. Consistent with previously announced interim findings, the final results showed target engagement and no apparent safety signals were observed across all tested doses. Detailed results from the Phase 1 trial will be presented at the Cure SMA annual conference. In the single-ascending dose, or SAD, portion of the trial, adverse events, or AEs, were observed in 30% of SRK-015-treated subjects and 50 % of placebo-treated subjects. In the multiple-ascending dose, or MAD, portion of the trial, AEs were observed in 35% of SRK-015-treated subjects and 67% of placebo-treated subjects. There were no discontinuations due to a treatment-related AE, no hypersensitivity reactions and no deaths. A single serious AE of gallstone-induced pancreatitis was observed in an SRK-015-treated subject and was assessed by the trial investigator as unrelated to treatment. Immunogenicity as evaluated by anti-drug antibody testing was negative for all SRK-015 treated subjects in the trial. Target engagement was shown in the Phase 1 trial through increases from baseline in levels of latent myostatin. The levels of target engagement attained a plateau after a single dose of SRK-015 at 3 mg/kg or greater, suggesting target saturation. This plateau was sustained up to Day 84 after a single dose at 20 mg/kg. This durability of effect was further shown in the MAD portion of the trial, during which the plateau was sustained up to at least day 140 after three doses given once every two weeks at 20 mg/kg or 30 mg/kg. In contrast, no meaningful change was observed in the latent myostatin biomarker concentrations in subjects who received placebo. PD was evaluated through a proprietary, exploratory biomarker assay developed by Scholar Rock that measures serum concentrations of latent myostatin. This assay was used previously to measure target engagement in preclinical studies in healthy animals and a mouse model of SMA. Pharmacokinetic, or PK, data. Drug exposure to SRK-015 was dose-proportional and SRK-015's serum half-life was 23-33 days across dose cohorts. In these respects, SRK-015 displayed a PK profile consistent with what is commonly observed for monoclonal antibodies.
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COUP | Hot Stocks16:10 EDT Coupa Software reports Q1 subscription revenue $73M, up 46% y/y - Reports Q1 calculated billings of $75.1M, up 50% y/y.
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BBSI | Hot Stocks16:07 EDT Barrett Business announces upcoming retirement of Gregory Vaughn COO - Barrett Business Services announced the upcoming retirement of Gregory Vaughn,COO of corporate operations, effective June 30. "On behalf of the board of directors of BBSI, I would like to express our gratitude to Greg for his service to the Company over the past 22 years," said Anthony Meeker, chairman of BBSI. "He has contributed tirelessly, and earned the trust and respect of the entire organization. We wish him well in his retirement."
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WAAS | Hot Stocks16:07 EDT AquaVenture's Quench to acquire Aguaman Inc, terms not stated - Quench, an operating segment of AquaVenture Holdings, announced that it has acquired substantially all of the assets of Aguaman, Inc., a point-of-use water filtration company based in Miami, Florida. This acquisition is Quench's 10th since the beginning of 2018 and adds approximately 900 customers, growing Quench's customer base by more than 50% in South Florida area.
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LEAF | Hot Stocks16:06 EDT Leaf Group appoints Brian Gephart Chief Accounting Officer - Leaf Group announced that it has named Brian Gephart as its Chief Accounting Officer. Formerly of JH Capital Group and PricewaterhouseCoopers, Gephart brings extensive expertise in technical accounting and financial reporting. He will oversee Leaf Group's accounting team and be responsible for the financial and accounting process.
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VTR | Hot Stocks16:06 EDT Ventas to acquire $1.8B seniors housing portfolio in Quebec in pact with LGM - Ventas announced that it has signed a definitive agreement to acquire a Class A portfolio of 31 purpose-built seniors housing communities and four in-progress developments in the attractive Quebec market by investing through an 85%/15% equity partnership with Le Groupe Maurice, or LGM. The portfolio is valued at C$2.4B or $1.8B including construction in progress. The LGM transaction is expected to close in two phases. The first phase - expected to close early in the third quarter of 2019 - includes a C$987M bridge loan from Ventas to LGM to enable it to buy out its current private equity partner. The second phase, full investment and partnership closing, is subject to the satisfaction of customary closing conditions, including receipt of regulatory approvals, and is expected to occur in the third quarter of 2019.
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ICE | Hot Stocks16:01 EDT IntercontinentalExchange names John Tuttle vice chairman of NYSE Group - Intercontinental Exchange, Inc. announced that John Tuttle has been appointed Vice Chairman and Chief Commercial Officer of NYSE Group. In this expanded new role, Tuttle will lead commercial outreach and business development of NYSE Group, spearhead its efforts to win the largest IPOs, grow the exchange's community of 2,300 listed companies, and oversee creation of new offerings for industries such as biotechnology and other growing sectors of the economy. Michael Blaugrund, currently Head of Transactions at the NYSE, has been promoted to Chief Operating Officer, overseeing strategy and operations of NYSE Group's five equities exchanges and two options exchanges. Blaugrund, who joined the NYSE from Tower Research Capital in 2016, served as the NYSE's Head of Equities before ascending to his current role. His career in financial services includes prior roles with Nasdaq, Thomson Reuters and Tradeweb.
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MRK | Hot Stocks15:53 EDT FDA approves new indication for Merck's Zerbaxa - The U.S. Food and Drug Administration approved a new indication for the previously FDA-approved drug, Zerbaxa for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in patients 18 years and older. The FDA initially approved Zerbaxa in 2014 to treat complicated intra-abdominal infections and for complicated urinary tract infections. The FDA granted the approval of Zerbaxa for the treatment of HABP/VABP to Merck & Co. "A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant infections," said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. "Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections that can result in death in some patients. New therapies to treat these infections are important to meet patient needs because of increasing antimicrobial resistance. That's why, among our other efforts to address antimicrobial resistance, we're focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections."
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AMD AAPL | Hot Stocks15:35 EDT AMD's Radeon Pro Vega II GPUs to be included in new Mac Pro - AMD (AMD) announced that its new AMD Radeon Pro Vega II GPUs will be included in the all-new Mac Pro (AAPL). Built on 7nm process technology, AMD Radeon Pro Vega II GPUs provide "groundbreaking levels of graphics performance for computation-intensive tasks, including rendering, 8K video, video effects, and other high-end content creation workloads," AMD said in a press release. "Today's high-end professional content creation applications are driving an insatiable need for ever increasing levels of processing power and memory," said Scott Herkelman, corporate vice president and general manager, Radeon Technologies Group at AMD. "Equipped with Radeon Pro Vega II GPUs, the new Mac Pro delivers the computational horsepower and memory bandwidth to power ultra-high screen resolutions and help dramatically accelerate compute and content creation workloads, enabling creative professionals to focus on unleashing their creativity and delivering amazing results."
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AAPL | Hot Stocks15:21 EDT Apple unveils new technologies for app development - Apple unveiled several technologies that "make it dramatically easier and faster for developers to create powerful new apps." SwiftUI is a development framework that makes building powerful user interfaces easier than ever before, the company said. ARKit 3, RealityKit and Reality Composer are advanced tools designed to make it even easier for developers to create AR experiences for consumer and business apps. New tools and APIs greatly simplify the process of bringing iPad apps to Mac, Apple said, adding that updates to Core ML and Create ML allow for more powerful and streamlined on-device machine learning apps. "The new app development technologies unveiled today make app development faster, easier and more fun for developers, and represent the future of app creation across all Apple platforms," said Craig Federighi, Apple's senior vice president of Software Engineering. "SwiftUI truly transforms user interface creation by automating large portions of the process and providing real-time previews of how UI code looks and behaves in-app. We think developers are going to love it."
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AAPL | Hot Stocks15:20 EDT Apple previews app development technologies - Apple unveiled several technologies that the company said will "make it dramatically easier and faster for developers to create powerful new apps." These include SwiftUI, which Apple called "a revolutionary development framework that makes building powerful user interfaces easier than ever before," and ARKit 3, RealityKit and Reality Composer, which the company said are "advanced tools designed to make it even easier for developers to create compelling AR experiences for consumer and business apps."
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AAPL | Hot Stocks15:18 EDT Apple previews macOS Catalina, replaces iTunes with three apps - Apple previewed macOS Catalina, which it said is "packed with cool new features, fresh new apps and powerful new technology for developers." With macOS Catalina, Apple is replacing iTunes with its entertainment apps - Apple Music, Apple Podcasts and the Apple TV app. "The all-new Sidecar feature enables users to extend their Mac desktop by using their iPad as a second display or as a high-precision input device across creative Mac apps. New security features keep users better protected and Voice Control lets users control their Mac entirely with their voice," the company stated. The developer preview of macOS Catalina is available to Apple Developer Program members starting today, and a public beta program will be available to Mac users later this month. macOS Catalina will be available this fall as a free software update for Macs introduced in mid-2012 or later.
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TXRH | Hot Stocks15:06 EDT Texas Roadhouse says Board approves $250M stock repurchase program - In a regulatory filing, Texas Roadhouse reported that its board of directors approved a stock repurchase program under which it authorized the company to repurchase up to $250M of its common stock. Any repurchases will be made through open market transactions. This stock repurchase program has no expiration date and replaces the previous stock repurchase program which was approved on May 22, 2014, the company noted.
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ADUS | Hot Stocks15:04 EDT Addus HomeCare completes VIP Health Care purchase, says looking for more deals - Addus HomeCare announced that it has completed the purchase of the assets of VIP Health Care Services, a provider of home care services, headquartered in Richmond Hill, New York, effective June 1. Dirk Allison, President and CEO of Addus, said, "We are very excited that the team at VIP Health Care Services will be joining the Addus organization. This acquisition is an important step to further our strategy of enhancing operations in key market areas where we already have a strong presence. VIP Health Care Services provides personal care coverage throughout the New York City area that complements our South Shore operations on Long Island. With annualized revenues of approximately $50.0 million, we will have combined revenues of over $110.0M in New York, which is already one of our largest markets. Additionally, with over 1,500 caregivers operating from six locations in the New York metropolitan area, we look forward to the potential growth opportunities in this important region. Now that we have completed the purchase of VIP Health Care Services, our development team is continuing to work on identifying other potential acquisition targets, and our pipeline remains strong. We will remain focused on opportunities that will enhance our service offering and further extend our market reach. With a strong financial position and substantial cash flow from operations, we believe we are well positioned to fund and execute additional accretive acquisitions during 2019."
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NK | Hot Stocks14:52 EDT NantKwest launches Phase 1 trial of CD19 t-haNK cell therapy in lymphoma - NantKwest announced that the company's t-haNK investigational new drug application has cleared FDA review and the program has now transitioned to a first-in-human clinical trial targeting CD19 t-haNK in advanced B-cell lymphoma. "Based on extensive and encouraging preclinical results, we have enhanced our ability to modularly combine this proprietary off-the-shelf t-haNK-based therapy with a wide range of monoclonal antibodies using this multi-targeted approach. We are now ready to transition this innovation in NK cell based therapeutics to a Phase I human clinical trials designed to assess the safety, tolerability and efficacy of CD19 t-haNK cell therapy in advanced b-cell lymphoma. Upon completion of the safety phase, NantKwest intends to combine this CD19 t-haNK cell therapy with other synergistic, immunomodulatory agents as part of an integrative, combination therapy approach that we describe as the NANT Cancer Vaccine to further enhance the synergistic effectiveness of this novel therapeutic intervention," said CEO Patrick Soon-Shiong.
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AAPL | Hot Stocks14:50 EDT Apple announces iPads will be able to be used as external screens for Macs
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AAPL | Hot Stocks14:48 EDT Apple introduces new Mac Pro, Pro Display XDR - Apple introduced the new Mac Pro, which the company called "a completely redesigned, breakthrough workstation for pros who push the limits of what a Mac can do." Apple also unveiled Pro Display XDR, which it called "the world's best pro display." Apple said: "Designed for maximum performance, expansion and configurability, the all-new Mac Pro features workstation-class Xeon processors up to 28 cores, a high-performance memory system with a massive 1.5TB capacity, eight PCIe expansion slots and a graphics architecture featuring the world's most powerful graphics card. It also introduces Apple Afterburner, a game-changing accelerator card that enables playback of three streams of 8K ProRes RAW video simultaneously." The new Mac Pro starts at $5,999 and will be available to order in the fall. Pro Display XDR starts at $4,999, the Pro Stand is $999 and the VESA Mount Adapter is $199. All will be available to order in the fall.
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AAPL | Hot Stocks14:46 EDT Apple announces MacOS Catalina operating system
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AAPL | Hot Stocks14:43 EDT Apple says Pro Display XDR starts at $4,999, available in the Fall - .
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AAPL | Hot Stocks14:42 EDT Apple says new Mac Pro starts at $5,999, available in the Fall
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AAPL | Hot Stocks14:41 EDT Apple says new Mac monitor called Pro Display XDR
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AAPL | Hot Stocks14:36 EDT Apple announces 32" LCD Retina 6K display for Mac Pro
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AAPL | Hot Stocks14:27 EDT Apple previews iOS 13 with Dark Mode, new camera features, improved maps - Apple previewed iOS 13, which the company said introduces "a dramatic new look for iPhone with Dark Mode and new ways to browse and edit photos, sign in to apps and websites, and navigate the world with an all-new map." Apple stated: "iOS 13 is faster and more responsive with optimizations across the system that improve app launch, reduce app download sizes and make Face ID even faster." Apple added: "Apple is introducing a new, more private way to simply and quickly sign into apps and websites. Instead of using a social account or filling out forms, verifying email addresses or choosing passwords, customers can simply use their Apple ID to authenticate and Apple will protect users' privacy by providing developers with a unique random ID...Apple Maps helps millions of people navigate and explore the world, all while protecting user privacy. After driving 4 million miles to rebuild the basemap from the ground up, Apple is delivering a new Maps experience with broader road coverage, better pedestrian data, more precise addresses and more detailed landcover. The new map is available now in select cities and states, and will roll out across the US by the end of 2019 and to more countries in 2020." The developer preview of iOS 13 is available to Apple Developer Program members starting today, and a public beta program will be available to iOS users later this month. New software features will be available this fall as a free software update for iPhone 6s and later, and will be available with iPadOS for iPad Air 2 and later, all iPad Pro models, iPad 5th generation and later, and iPad mini 4 and later.
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AAPL | Hot Stocks14:26 EDT Apple announces tvOS 13 operating system for Apple TV - Apple previewed tvOS 13, the operating system that the company said "makes Apple TV 4K the easiest and most personalized entertainment device for enjoying TV shows, movies, music, photos, games and apps on the biggest screen in the home." Apple added that, with tvOS 13, "Apple TV 4K gains an immersive new Home screen; multi-user support for customers to access their own TV shows, movies, music and recommendations; support for Apple Arcade; expanded game controller support; and new 4K HDR screen savers filmed under the sea." The tvOS developer preview is available for Apple Developer Program members starting today, and a public beta program will be available to tvOS users later this month. tvOS 13 will be available this fall as a free software update for Apple TV 4K and Apple TV HD.
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BMY | Hot Stocks14:24 EDT Bristol-Myers updates results from studies evaluating Opdivo - Bristol-Myers Squibb announced updated results from studies evaluating Opdivo alone or in combination, in patients with advanced or metastatic melanoma. These analyses will be featured on Monday, June 3 from 1:15-4:15 PM CDT at the American Society of Clinical Oncology 2019 Annual Meeting in Chicago. A five-year analysis of the Phase 1 CA209-004 study, the longest follow-up for the Opdivo plus Yervoy combination in patients with previously treated or untreated advanced melanoma to date, showed that with a median follow-up of 43.1 months in all patients, at four years or longer, overall survival rates were stable at 57%.The three-year OS rate following discontinuation of therapy was 56%. The study also showed long-term survival outcomes with Opdivo plus Yervoy, regardless of BRAF or lactate dehydrogenase status, with four-year OS rates of 62% versus 49% for patients with normal and elevated LDH, respectively, and four-year OS rates of 54% and 61% for patients with wild-type and mutant BRAF tumors, respectively. The overall safety of the combination was consistent with previously reported studies of these medicines in patients with advanced melanoma.
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AAPL | Hot Stocks14:23 EDT Apple previews iPadOS with new home screen, split view, Dark Mode - Apple previewed iPadOS, which the company called "the powerful operating system with a new name to recognize the distinctive experience of iPad." Apple said: "iPadOS builds on the same foundation as iOS, adding powerful new capabilities and intuitive features specific to the large display and versatility of iPad...The Home screen has been redesigned with a new layout to show more apps on each page...iPad users can now work with multiple files and documents from the same app simultaneously with updates to Split View, or can quickly view and switch between multiple apps in Slide Over...With iPadOS, Apple Pencil is even more integrated into the iPad experience...Dark Mode delivers a dramatic dark color scheme that looks great across the system and is easier on the eyes in low-light environments." The developer preview of iPadOS is available to Apple Developer Program members starting today, and a public beta program will be available to iPadOS users later this month. iPadOS will be available this fall as a free software update for iPad Air 2 and later, all iPad Pro models, iPad 5th generation and later and iPad mini 4 and later.
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AAPL | Hot Stocks14:23 EDT Apple announces watchOS 6 operating system for Apple Watch - Apple previewed watchOS 6, which "empowers Apple Watch users to better manage their health and fitness, and gives access to dynamic new watch faces and the App Store directly on Apple Watch." Apple watchOS 6 brings the App Store directly to Apple Watch. Users can install third-party apps, search for apps using Siri, dictation or Scribble and view app product pages designed for the watch screen right from the wrist. Developers can build Apple Watch-only apps, created to work independently on Apple Watch without an iOS app. The developer preview of watchOS 6 is available to Apple Developer Program members starting today. New software features will be available this fall as a free software update for Apple Watch Series 1 or later paired with iPhone 6s or later running iOS 13 or later.
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AAPL | Hot Stocks14:20 EDT Apple announces new Apple Mac Pro - This comment was made by Apple CEO Tim Cook at the Apple Special Event.
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TWTR | Hot Stocks14:20 EDT Twitter acquires London-based deep learning firm Fabula AI, terms undisclosed - Twitter has acquired London-based AI firm Fabula AI. Twitter said in a blog posting: "We are excited to announce that, to help us get there, we have acquired Fabula AI, a London-based start-up, with a world-class team of machine learning researchers who employ graph deep learning to detect network manipulation. Graph deep learning is a novel method for applying powerful ML techniques to network-structured data. The result is the ability to analyze very large and complex datasets describing relations and interactions, and to extract signals in ways that traditional ML techniques are not capable of doing.This strategic investment in graph deep learning research, technology and talent will be a key driver as we work to help people feel safe on Twitter and help them see relevant information. Specifically, by studying and understanding the Twitter graph, comprised of the millions of Tweets, Retweets and Likes shared on Twitter every day, we will be able to improve the health of the conversation, as well as products including the timeline, recommendations, the explore tab and the onboarding experience." Reference Link
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DVAX | Hot Stocks14:19 EDT Dynavax reports results from Phase 1b/2 study of SD-101 and Keytruda combination - Dynavax Technologies announced "increasingly favorable" results from the Phase 1b/2 SYNERGY-001 open-label, multicenter study of the combination of SD-101 and KEYTRUDA in advanced melanoma patients who are naive to anti-PD-1/PD-L1 treatment. The results were presented today in a poster session at the 2019 American Society of Clinical Oncology, or ASCO, Annual Meeting. The overall response rate, or ORR, in the SD-101 2 mg/lesion group of 76% was higher than in the SD-101 8 mg/lesion group at 49%. The median duration of response, or DOR, in both groups has not been reached, with the lower bound of the 95% confidence interval of at least 14 months. The 18-month progression free survival, or PFS, rate in the SD-101 2 mg/lesion group of 72% was higher than in the SD-101 8 mg/lesion group at 36%. Similar rates of responses occurred in patients with PD-L1 negative tumors and PD-L1 positive tumors. Tumor shrinkage has been observed in both injected and non-injected lesions, including visceral lesions such as the liver and lung. In addition, the company presented data from the Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced/metastatic melanoma resistant to anti-PD-1/PD-L1 therapy.
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AAPL | Hot Stocks14:18 EDT Apple CEO Tim Cook says Apple Mac #1 in customer satisfaction
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VWAGY | Hot Stocks14:16 EDT Volkswagen plans dual listing for TRATON SE - Volkswagen AG and TRATON SE announce that they are preparing an initial public offering of TRATON and a listing of TRATON shares on the Regulated Market of the Frankfurt Stock exchange and the Regulated Market of Nasdaq Stockholm. The IPO is expected to be completed before the summer break 2019, subject to market conditions. "Given TRATON's strong balance sheet, the IPO is anticipated to consist of existing shares held by Volkswagen only. Volkswagen, which intends to remain a committed shareholder of TRATON, will retain a majority stake in TRATON following the completion of the IPO," the company stated. The TRATON GROUP's operations are divided into two reportable segments, the Industrial Business segment and Financial Services segment. The Industrial Business, which constitutes the core of the Group's business and accounted for 95% of the Group's sales revenue in the fiscal year 2018, comprises the three operating units MAN Truck & Bus, Scania Vehicles & Services, and VWCO, while Financial Services offers its customers a range of financial services, including dealer and retail financing, leasing, banking and insurance products. The IPO is expected to comprise a public offering in Germany and Sweden and private placements in certain other jurisdictions. In the United States of America, the shares of TRATON are planned to be offered and sold only to Qualified Institutional Buyers as defined in and in reliance on Rule 144A under the United States Securities Act of 1933, as amended.
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AAPL | Hot Stocks14:06 EDT Apple announces iPad OS operating system
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UPS | Hot Stocks13:59 EDT UPS appoints Charlene Thomas as Chief Human Resources Officer - UPS announced the appointment of Charlene Thomas as Chief Human Resources Officer, effective July 1, and the retirement of Teri McClure. Charlene Thomas joins the UPS Management Committee, the company's senior-most leadership group, and will report to UPS Chairman and CEO David Abney. Charlene began her career at UPS in 1989 and has progressed through successive leadership roles at the company, UPS noted.
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MRTX AMGN | Hot Stocks13:49 EDT Mirati Therapeutics jumps after Amgen announces AMG 510 data - Shares of biotech firm Mirati Therapeutics (MRTX) are spiking higher on Monday after large-cap peer Amgen (AMGN) announced the first clinical results from a Phase 1 study evaluating investigational AMG 510, the first KRASG12C inhibitor to reach the clinical stage. In the trial, there were no dose-limiting toxicities at tested dose levels. AMG 510 showed anti-tumor activity when administered as a monotherapy in patients with locally-advanced or metastatic KRASG12C mutant solid tumors, Amgen said in a statement. MIRATI'S CANDIDATE: Mirati Therapeutics is developing a KRAS G12C Inhibitor like Amgen's AMG 510. According to the company, MRTX849 has demonstrated broad-spectrum antitumor activity across a panel of KRAS G12C-positive patient- and cell-derived in vivo tumor models, including complete tumor regression in a subset of these models. MRTX849 is now in the clinic and has the potential to provide a long-awaited targeted therapy option for patients exhibiting a KRAS driver mutation, Mirati said on its website. PRICE ACTION: Shares of Mirati Therapeutics are up 31% to $88.39 in afternoon trading, while Amgen is up almost 5% to $174.41.
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BA | Hot Stocks13:45 EDT Boeing CEO expects Max to fly again this year, but not sure of timimg - Dennis Muilenburg is speaking on CNBC.
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BA | Hot Stocks13:45 EDT Boeing has not had single order for Max since grounding, CEO says - Dennis Muilenburg is speaking on CNBC.
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BA | Hot Stocks13:44 EDT Boeing has not had single order for Max since grounding, CNBC says - Dennis Muilenburg is speaking on CNBC.
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BA | Hot Stocks13:44 EDT Boeing plans to step up Max production to 52 per month, CEO says - Dennis Muilenburg is speaking on CNBC.
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AAPL | Hot Stocks13:43 EDT Apple announces Log in with Apple privacy feature
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BA | Hot Stocks13:43 EDT Boeing CEO says long-term MAX production plans have not changed - Dennis Muilenburg is speaking on CNBC.
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BA | Hot Stocks13:42 EDT Boeing CEO can't give specific timeline on end of 737 Max grounding - Dennis Muilenburg is speaking on CNBC.
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BA | Hot Stocks13:40 EDT Boeing CEO says third party being brought in with customer collaboration - Dennis Muilenburg is speaking on CNBC.
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BA | Hot Stocks13:39 EDT Boeing CEO believes he is right person to lead the company - Dennis Muilenburg is speaking on CNBC.
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BA | Hot Stocks13:38 EDT Boeing CEO admits company 'has fallen short in the past' - Dennis Muilenburg is speaking on CNBC.
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BA | Hot Stocks13:37 EDT Boeing CEO says improvements can be made in transparency, MCAS systems - Dennis Muilenburg is speaking on CNBC.
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AAPL... | Hot Stocks13:37 EDT Apple falls during WWDC as Reuters reports DOJ given jurisdiction for probe - A part of a broad tech review among antitrust enforcement agencies, the Department of Justice has been given jurisdiction over Apple (AAPL), Reuters reported, citing sources. The Federal Trade Commission intends to open an antitrust probe into Facebook (FB) under an arrangement that gives the Justice Department chief oversight of Alphabet's (GOOG) Google, The Wall Street Journal reported earlier today. Following the Reuters headlines, shares of Apple are down roughly 2% while the tech giant is conducting its Annual Worldwide Developers Conference.
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BA | Hot Stocks13:36 EDT Boeing CEO says 'very sorry' for both 737 Max accidents - Dennis Muilenburg is speaking on CNBC.
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BA | Hot Stocks13:35 EDT Boeing CEO says Max 737 followed certification processes - Dennis Muilenburg is speaking on CNBC.
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BA | Hot Stocks13:34 EDT Boeing CEO says 'taking a look' at certification processes - Dennis Muilenburg is speaking on CNBC.
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BA | Hot Stocks13:33 EDT Boeing CEO 'confident' Max will be one of the safest airplanes when back - Dennis Muilenburg is speaking on CNBC.
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AAPL | Hot Stocks13:32 EDT Apple announces dark mode for iPhone iOS 13
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SPY SPX | Hot Stocks13:31 EDT Fed's Bullard says rate cut 'may be warranted soon' - James Bullard, President of the Federal Reserve Bank of St. Louis, said in remarks prepared for a presentation to the Union League Club of Chicago, that the U.S. economy "is expected to grow more slowly in 2019; inflation expectations appear to be too low to be consistent with the inflation target of the Federal Open Market Committee; [and] the Treasury yield curve has moved more decisively toward inversion. These considerations suggest a downward adjustment in the policy rate-the federal funds rate target range-may be warranted soon." Reference Link
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AAPL | Hot Stocks13:30 EDT Apple announces iOS 13 - Apple said that unlocking with Face ID is now 30% faster, app launch speed is up to 2x faster.
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AAPL | Hot Stocks13:28 EDT Apple CEO Tim Cook says 85% of iOS customers on latest release
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IBM | Hot Stocks13:28 EDT IBM launches 'self-service advertising solution' Watson Ads Builder - IBM announced the launch of Watson Ads Builder, a self-service advertising solution that harnesses artificial intelligence, AI,designed to empower creative agencies and developers to help them build engaging, one-on-one conversations between brands and consumers across any digital property. Watson Ads Builder is designed to enable agencies and developers to ingest and understand a brand's information and create dialogue that is unique to each consumer, helping to deepen engagement and drive brand loyalty. For example, a creative agency can leverage Watson Ads Builder to create a unique brand experience for an airline client. The ad can enable a conversation and answer the most anticipated questions, like the best time to purchase a plane ticket or details around in-flight experiences -- all based on near real-time dialogue. Prior to Watson Ads Builder, the typical conversational design solutions might take months to develop and could require specialized skills and manual effort. Watson Ads Builder can help simplify this process by using Natural Language Generation and Watson technology to encourage brands to create, deploy, chat and connect with consumers with speed. "Consumer expectations are shifting, and people expect the ability to communicate with brands on demand," said Jeremy Hlavacek, Head of Revenue for IBM Watson Advertising. "Watson Ads Builder can change where, when and how brands connect with consumers -- helping marketers increase loyalty and purchase consideration."
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AAPL | Hot Stocks13:17 EDT Apple announces App Store for Apple Watch
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AAPL | Hot Stocks13:13 EDT Apple's Tim Cook says Apple TV to get support for XBox, Playstation controllers
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AAPL | Hot Stocks13:11 EDT Apple announces multiple user support for Apple TV, Apple Music - This comment was made by Apple CEO Tim Cook at the Apple Special Event.
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RTN | Hot Stocks12:32 EDT Raytheon awarded U.S. Air Force contract to mentor small business - Raytheon and Infinity Technology Services won a two-year Mentor Protege program contract from the U.S. Air Force. "Mentor Protege programs help the Department of Defense diversify its supplier base by giving small businesses experience in high-demand disciplines with a mentor company." Raytheon will help ITS mature its cybersecurity design, testing, defense and verification capabilities.
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NFLX... | Hot Stocks12:32 EDT Netflix, Russo brothers to create 'Magic: The Gathering' series - Netflix (NFLX) announced that it is joining forces with Joe and Anthony Russo, Wizards of The Coast, and Hasbro's (HAS) Allspark Animation to bring the world of trading card game Magic: The Gathering to the screen for the first time in the franchise's 25-year history with an animated series "Magic: The Gathering." The Russos, who directed Disney's (DIS) "Avengers: Infinity War" and "Avengers: Endgame," will oversee the creation of an all new storyline and expand on the stories of the Planeswalkers, which are Magic's unique magic-wielding heroes and villains as they contend with stakes larger than any one world can hold. Reference Link
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FB | Hot Stocks12:15 EDT Facebook down 6% after reports of FTC competition probe - Facebook shares are down $11.33, or 6.38%, to $166.14 following reports that the FTC will be leading an antitrust investigation into the social media giant. Both Bloomberg and The Wall Street Journal have reported on the FTC probe of Facebook.
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VWAGY NIO | Hot Stocks12:12 EDT Volkswagen's ID.R achieves new electric lap record on Nurburgring - Volkswagen's (VWAGY) Motorsport account tweeted that the car maker's ID.R electric racecar achieved a new electric lap record on the Nurburgring-Nordschleife track in Germany. "6:05.336 minutes! New electric lap record by the Volkswagen ID.R on the Nurburgring-Nordschleife," the company said. "Another milestone in electro-mobility." The Verge notes that the ID.R beat the record established by NIO's (NIO) EP9 supercar in 2017. Reference Link
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LEU | Hot Stocks11:56 EDT Centrus Energy awarded $115M U.S. DOE contract - Centrus Energy has been awarded a $115M contract by the U.S. Department of Energy to "facilitate the demonstration of high assay low enriched uranium production to support DOE research and development activities and programs." Reference Link
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ELLXF | Hot Stocks11:10 EDT Elixinol says hopes FDA 'takes strikes' in acceptance of hemp-driven CBD - Elixinol issued the following statement regarding the public FDA hearing in Washington, D.C. on Friday, May 31. "We support the FDA's intentions, we want consumers to make educated decisions, and we want the market to universally supply CBD that's free of metals, molds and pesticides and safe for consumers. Additionally, we support the industry's intentions to develop best-in-class standards, like those of the U.S. Hemp Authority, whose seal of approval means the brand has been through a stringent review of processes, procedures and employee training. We're proud to be one of the first brands to be U.S. Hemp Authority certified. Now that the hearing has ended, we will wait for the outcome to unfold, hoping to see the FDA takes strides in their acceptance of hemp-derived CBD. FDA permitting hemp-derived CBD oil as a food additive will open the floodgates of CBD-infused food and drink, as we see industry projections that U.S. CBD sales will climb from a $600M market in 2018, to a $22B market by 2022, as cited by Green Entrepreneur."
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RDY RHHBY | Hot Stocks10:44 EDT Dr. Reddy's announces re-launch of Zenatane in the U.S. market - Dr. Reddy's Laboratories (RDY) announced the re-launch of Zenatane, 10 mg, 20 mg, 30 mg and 40 mg, a therapeutic equivalent generic version of Accutane, approved by the U.S. Food and Drug Administration. The product is being launched with an approved Risk Evaluation and Mitigation Strategy Program. The Zenatane, 10 mg, 20 mg, 30 mg and 40 mg brand and generic had U.S. sales of approximately $525M MAT for the most recent twelve months ending in March 2019 according to IQVIA Health. Accutane is a trademark of Hoffman LaRoche (RHHBY).
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VUZI | Hot Stocks10:37 EDT Vuzix receives Blade smart glasses purchase order from new partner - Vuzix Corporation announced that it has moved past a proof of concept with a new prosumer-oriented partner and has received a purchase order for 100 Blade Smart Glasses to be integrated into their smart wearable consumer sports platform for production. The proof of concept phase with this company began in Q1 2019 with their initial purchase of Blade units and has proven "very successful," Vuzix said in a statement. The Blade Smart Glasses deployment program with this new partner is expected to expand to approximately 1,000 deployed systems before the end of 2019, it added.
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MKGAY | Hot Stocks10:29 EDT Merck KGaA says tepotinib shows 'durable anti-tumor clinical activity' - Merck KGaA presented updated results from the potentially registrational Phase II Visoin study, showing "durable anti-tumor clinical activity" for the investigational targeted therapy tepotinib across different lines of treatment in advanced non-small cell lung cancer patients harboring MET exon 14 skipping mutations detected by liquid biopsy or tissue biopsy. "Tepotinib has been designed to potentially improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations," said Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck KGaA, Darmstadt, Germany. "Tepotinib is an important part of our strategic focus on precision medicine, and both the proportion of patients responding and the duration of anti-tumor clinical activity demonstrate the potential of this investigational therapy." Results from the ongoing Phase II Vision study in 73 efficacy-evaluable patients with NSCLC with MET exon 14 skipping mutations identified by LBx or TBx demonstrate overall objective response rate of 50.0% for LBx-identified patients as assessed by Independent Review Committee, and 55.3% as assessed by investigators. The ORR for TBx-identified patients was 45.1% and 54.9%, respectively. The overall median duration of response was 12.4 months and 17.1 months among LBx-identified patients, as assessed by IRC and investigators, respectively, while among TBx-identified patients, 15.7 and 14.3 months were observed, respectively. Most treatment-related adverse events were Grade 1 and 2, Merck KGaA said in a statement.
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NSANY | Hot Stocks10:23 EDT Nissan reports May U.S. sales up 0.1% to 131,983 vehicles - Nissan Group announced total U.S. sales for May 2019 of 131,983 units, an increase of 0.1% compared to the prior year. Sales of the Armada SUV set a May record with 4,490 units sold, up 103%. Pathfinder SUV sales, at 7,751 units, were up 27% in May. Frontier truck sales increased 8% to 7,497 units.
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HMC | Hot Stocks10:07 EDT Honda reports May U.S. sales down 4.9% to 145,532 vehicles - Honda's U.S. sales fell 4.9% in May to 145,532 vehicles. Acura sales increased 5.7% in May, the company said. "We're seeing growth opportunities in cars and light trucks for both Honda and Acura brands as the market continues to level off," said Henio Arcangeli, Jr. senior vice president of Automobile Sales at American Honda Motor Co. "Acura SUVs are leading the charge in luxury with RDX and MDX as consistent top sellers, while the Honda brand is extending its industry leadership in passenger car sales and building toward a full decade of SUV sales growth."
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ATI | Hot Stocks10:06 EDT Wynnchurch Capital acquires certain assets of Allegheny Technologies - Wynnchurch Capital announced that it has completed the acquisition of two closed-die forging facilities of Allegheny Technologies Incorporated. The operations are located in Portland, Indiana and Lebanon, Kentucky and were part of ATI's High Performance Materials & Components segment. Wynnchurch Capital is actively investing from its $1.3B Fund IV.
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MYOV | Hot Stocks10:00 EDT Myovant Sciences falls -6.5% - Myovant Sciences is down -6.5%, or -64c to $9.19.
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CEL | Hot Stocks10:00 EDT Cellcom Israel falls -6.9% - Cellcom Israel is down -6.9%, or -26c to $3.51.
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CNC | Hot Stocks10:00 EDT Centene falls -7.4% - Centene is down -7.4%, or -$4.28 to $53.47.
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HMI | Hot Stocks10:00 EDT Huami rises 13.8% - Huami is up 13.8%, or $1.01 to $8.35.
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EE | Hot Stocks10:00 EDT El Paso Electric rises 14.0% - El Paso Electric is up 14.0%, or $8.16 to $66.36.
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SMTA | Hot Stocks10:00 EDT Spirit MTA REIT rises 18.1% - Spirit MTA REIT is up 18.1%, or $1.27 to $8.30.
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BIG | Hot Stocks09:47 EDT Big Lots falls -4.8% - Big Lots is down -4.8%, or -$1.33 to $26.27.
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PHI | Hot Stocks09:47 EDT PLDT falls -5.1% - PLDT is down -5.1%, or -$1.29 to $24.01.
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CNC | Hot Stocks09:47 EDT Centene falls -7.2% - Centene is down -7.2%, or -$4.14 to $53.61.
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CODI | Hot Stocks09:47 EDT Compass Diversified rises 7.7% - Compass Diversified is up 7.7%, or $1.19 to $16.74.
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EE | Hot Stocks09:47 EDT El Paso Electric rises 14.0% - El Paso Electric is up 14.0%, or $8.17 to $66.37.
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SMTA | Hot Stocks09:47 EDT Spirit MTA REIT rises 16.9% - Spirit MTA REIT is up 16.9%, or $1.19 to $8.22.
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MO | Hot Stocks09:43 EDT Altria Group to acquire 80% ownership of certain Burger Group companies - Altria Group earlier announced that it has entered into definitive agreements with the shareholders of Burger Sohne Holding AG, based in Switzerland, to acquire 80% ownership of certain companies of the Burger Group that will commercialize on! products worldwide. on! is an oral tobacco-derived nicotine pouch product. "We're excited to add on! to our companies' terrific non-combustible portfolio," said Howard Willard, Altria's Chairman and CEO. "Through our companies and investments, we have access to the leading products and brands in the moist smokeless tobacco, e-vapor and heated tobacco categories. This acquisition will add another non-combustible product to our portfolio in what we believe is a high-potential, rapidly-developing oral TDN products category." Upon closing, Altria will invest $372M for an 80% ownership interest in the global business. Altria expects to complete the transaction in the second half of 2019, subject to customary closing conditions, and to finance the transaction with available cash.
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HMC | Hot Stocks09:40 EDT Honda's May U.S. sales fell 4.9%, Bloomberg reports
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FCAU | Hot Stocks09:33 EDT Fiat Chrysler reports May U.S. sales up 2% to 218,702 vehicles - It was the best May ever for the Jeep Grand Cherokee and the highest level of May sales for the Dodge Charger in six years, Fiat Chrysler said in a statement. Overall, total sales rose 2% to 218,702 vehicles. Fleet represented 31% of total sales during the month. On a year-to-date basis, fleet accounted for 22 percent of sales. "On a year-over-year basis we have increased our average transaction prices by more than $3,000 a vehicle and still managed some notable sales increases," said Reid Bigland, U.S. Head of Sales. "In its first full month on sale, our all new Jeep Gladiator pickup truck delivered more than 2,500 vehicle sales, our Ram pickup truck sales soared 33 percent and the Jeep Grand Cherokee delivered its best May sales ever."
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DGX | Hot Stocks09:33 EDT Quest Diagnostics notified of breach at billing collections vendor - In a regulatory filing earlier, Quest Diagnostics disclosed that on May 14, American Medical Collection Agency, a billing collections vendor, notified Quest and Optum360, Quest Diagnostics' revenue cycle management provider, of potential unauthorized activity on AMCA's web payment page. "Quest Diagnostics and Optum360 promptly sought information from AMCA about the incident, including what, if any, information was subject to unauthorized access. Although Quest Diagnostics and Optum360 have not yet received detailed or complete information from AMCA about the incident, AMCA has informed Quest Diagnostics and Optum360 that: between August 1, 2018 and March 30, 2019 an unauthorized user had access to AMCA's system that contained information that AMCA had received from various entities, including Quest Diagnostics, and information that AMCA collected itself; the information on AMCA's affected system included financial information, medical information and other personal information; as of May 31, 2019, AMCA believes that the number of Quest Diagnostics patients whose information was contained on AMCA's affected system was approximately 11.9 million people; and AMCA has been in contact with law enforcement regarding the incident. Quest Diagnostics has not been able to verify the accuracy of the information received from AMCA. Quest Diagnostics' laboratory test results were not provided to AMCA and were therefore not impacted by this incident. In response to this incident, Quest Diagnostics has: suspended sending collection requests to AMCA; provided notifications to affected health plans and will ensure that notification is provided to regulators and others as required by federal and state law; and been working and will continue to work diligently, along with Optum360, AMCA and outside security experts, to investigate the AMCA data security incident and its potential impact on Quest Diagnostics and its patients. Quest Diagnostics has insurance coverage in place for certain potential liabilities and costs relating to the incident; this insurance is limited in amount and subject to a deductible. Quest Diagnostics takes this matter very seriously and is committed to the privacy and security of patients' personal, medical and financial information," the filing stated.
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BLUE | Hot Stocks09:30 EDT Bluebird Bio announces EU conditional marketing authorization for ZYNTEGLO - bluebird bio announced that the European Commission has granted conditional marketing authorization for ZYNTEGLO, a gene therapy for patients 12 years and older with transfusion-dependent beta-thalassemia who do not have a beta0/beta0 genotype, for whom hematopoietic stem cell transplantation is appropriate but a human leukocyte antigen-matched related HSC donor is not available. bluebird bio will continue the country-by-country reimbursement process to help ensure access to ZYNTEGLO for appropriate patients. TDT is a severe genetic disease caused by mutations in the beta-globin gene that result in reduced or absent hemoglobin. In order to survive, people with TDT maintain hemoglobin levels through lifelong chronic blood transfusions. These transfusions carry the risk of progressive multi-organ damage due to unavoidable iron overload. ZYNTEGLO is a one-time gene therapy that addresses the underlying genetic cause of TDT and offers patients 12 years and older who do not have a beta0/beta0 genotype the potential to become transfusion independent, which once achieved is expected to be life-long. ZYNTEGLO was reviewed as part of the European Medicines Agency's Priority Medicines and Adaptive Pathways programs, which support medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options.
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AMD SSNLF | Hot Stocks09:27 EDT Samsung to pay AMD license fees and royalties under new partnership - AMD (AMD) and Samsung Electronics (SSNFL) announced a multi-year strategic partnership in ultra low power, high performance mobile graphics IP based on AMD Radeon graphics technologies. As part of the partnership, Samsung will license AMD graphics IP and will focus on advanced graphics technologies and solutions that are critical for enhancing innovation across mobile applications, including smartphones, the companies said in a statement. AMD will license custom graphics IP based on the recently announced RDNA graphics architecture to Samsung for use in mobile devices, including smartphones, and other products that complement AMD product offerings. Samsung will pay AMD technology license fees and royalties. "As we prepare for disruptive changes in technology and discover new opportunities, our partnership with AMD will allow us to bring groundbreaking graphics products and solutions to market for tomorrow's mobile applications," said Inyup Kang, president of Samsung Electronics' S.LSI Business. "We look forward to working with AMD to accelerate innovations in mobile graphics technologies that will help take future mobile computing to the next level." Shares of AMD are up 5%, or $1.37, to $28.78 in premarket trading following the announcement.
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CNST | Hot Stocks09:26 EDT Constellation Pharmaceuticals announces presentation of MANIFEST data at ASCO - Constellation Pharmaceuticals announced the presentation of updated interim data from MANIFEST, the company's Phase 2 clinical trial of CPI-0610 in refractory myelofibrosis, or MF. The interim data, which highlight the tolerability and potentially disease-modifying activity of CPI-0610, were presented in a poster at the annual meeting of the American Society for Clinical Oncology, or ASCO. The data were gathered from 44 patients enrolled as of April 17. Twelve patients received 24-week assessments and 16 patients received 12-week assessments. Fourteen of 16 evaluable patients demonstrated spleen volume reductions. Overall, the median best on-trial spleen volume change from baseline was -19.2%. Of these 16 evaluable patients, 11 were evaluable for improvement in total symptom score, or TSS, according to the Myelofibrosis Symptom Assessment Form. Six of the 11 evaluable patients achieved greater than 50% TSS improvement from baseline as a best response. All of these 16 patients were evaluable for patient global impression of change, or PGIC. Fifteen of 16 evaluable patients reported improvements in PGIC, of which 10 reported feeling either "much improved" or "very much improved" and no patients reported feeling worse following treatment. Of 12 evaluable patients who received at least 24 weeks of treatment, three were severely anemic and dependent on red-blood-cell transfusions at baseline. Of these three patients, two converted to transfusion independence. These two patients have remained transfusion independent for more than 69 and 24 weeks, respectively, as of April 17 and remain on trial.mTen patients were evaluable for bone marrow fibrosis, of which six experienced improvement in bone marrow morphology of at least one point on a scale of 0-3. Four of these six patients exhibited improvements within six months of starting CPI-0610 therapy. Based on the interim data, CPI-0610 was generally well-tolerated, both as a monotherapy and in combination with ruxolitinib. Overall, the most commonly reported side effects were diarrhea, vomiting, upper respiratory tract infection, headache, epistaxis, fatigue, dysgeusia, cough and pruritis. Grade 3 or greater treatment-emergent adverse events were only reported in the combination arm, and those reported in more than one patient included thrombocytopenia, anemia, and decreased platelet counts, each of which was reported in two patients. There was one patient death, which the company assessed as unlikely to have been related to CPI-0610. The combination therapy of CPI-0610 and ruxolitinib showed a non-cumulative, manageable, and mostly reversible asymptomatic thrombocytopenia. Each of the first four patients enrolled in MANIFEST, of which two received CPI-0610 as a monotherapy and two received CPI-0610 in combination with ruxolitinib, remained on therapy and had been treated for approximately 16 and 20 months, respectively, as of April 17.
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AMD | Hot Stocks09:23 EDT AMD jumps 5% to $28.88 after announcing partnership with Samsung
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AMD SSNLF | Hot Stocks09:23 EDT AMD, Samsung announce multi-year strategic partnership
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TM | Hot Stocks09:18 EDT Toyota Motor North America reports May sales up 3.2% to 222,174 vehicles - Toyota Motor North America reported May 2019 sales of 222,174 vehicles, an increase of 3.2% on a volume and daily selling rate basis versus May 2018. Toyota division posted May sales of 197,637 units, up 4.1% on a volume and DSR basis. Lexus division posted May sales of 24,537 vehicles, down 3.4% on a volume and DSR basis.
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CNR | Hot Stocks09:17 EDT Cornerstone Building Brands names Jeffrey Lee as CFO, effective June 17 - Cornerstone Building Brands announced that its Board of Directors has appointed Jeffrey Lee as Executive Vice President and CFO, effective June 17. Lee will assume the role from Executive Vice President and CFO Shawn Poe, who announced his retirement earlier this year. Lee currently holds the position of Vice President and CFO of Wilsonart International Holdings.
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APTO | Hot Stocks09:17 EDT Aptose Biosciences appoints Jotin Marango CBO - Aptose Biosciences announced the appointment of Jotin Marango to the position of senior VP chief business officer, or CBO, effective immediately. In his role as a member of the executive leadership team, Marango is responsible for Aptose's corporate and business development initiatives, including licensing and alliance management, business and product strategy, as well as market and competitive intelligence. Marango brings to Aptose years of industry experience, most recently as a senior research analyst at Roth Capital Partners, where he covered biotechnology and therapeutics.
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SGMS | Hot Stocks09:15 EDT Scientific Games renews contract for use of Fremantle TV game show brands - Scientific Games announced that it has renewed a contract with Fremantle for the exclusive rights to use three iconic TV game show brands in lottery games through 2022. Scientific Games will continue to create games for lotteries in the U.S. and Canada featuring THE PRICE IS RIGHT and FAMILY FEUD and in the U.S. featuring PRESS YOUR LUCK.
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OSS | Hot Stocks09:14 EDT One Stop Systems wins joint design-in from transportation network company - One Stop Systems won an exclusive joint design-in from an international transportation network company for the design, engineering, prototyping and production of AI on the Fly system elements for use in 150 next-generation autonomous vehicles. The initial orders, valued at more than $1M, include collaborative engineering design from the OSS and CDI design teams, 150 liquid-cooled compute accelerators from OSS and networking boards from CDI. The engineering and equipment will be designed to support in-vehicle artificial intelligence training and inferencing. CDI's design and manufacturing of custom networking hardware will include a redundant-path IEC 62439-3:2016 compliant ethernet device that supports precision time protocol. The company expects to ship prototypes in Q3, followed by full production units in Q4.
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OTIV | Hot Stocks09:14 EDT On Track Innovations receives order for 2,000 advanced payment systems in Russia - On Track Innovations announced that it had received another significant order for more than 2,000 advanced payment systems for use in Russian ticketing. This additional order builds on OTI's previous success in the significant Russian market, having delivered to date almost 18,000 cashless payment systems.
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MEIP | Hot Stocks09:12 EDT MEI Pharma presents new clinical data on ME-401 - MEI Pharma announced that updated data presented at ASCO 2019 from a Phase 1b study of investigational ME-401, a selective oral inhibitor of PI3K delta, demonstrate an 80% overall response rate in patients with relapsed or refractory follicular lymphoma. Additionally, the data demonstrate: Comparable overall response rates, ranging from 75%-83%, across patient groups receiving ME-401 as a monotherapy or in combination with rituximab, and in patient groups dosed with ME-401 once daily on a continuous schedule or on an intermittent schedule of once daily for the first 7 days of a 28-day cycle after 2 months of continuous dosing. A lower rate of delayed, grade 3 adverse events observed in patients in the IS group. Durable responses in both CS and IS groups with no median yet reached.
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GOOGL... | Hot Stocks09:11 EDT Fly Intel: Pre-market Movers - HIGHER: Cypress (CY), up 26% after announcing Infineon (IFNNY) will acquire the company for $23.85 per share in cash, corresponding to an enterprise value of EUR9B... Humana (HUM), up 3% after confirming it will not propose a merger with Centene (CNC)... Genocea (GNCA), up 88% after announcing clinical results from its ongoing Phase 1/2a trial for GEN-009, the company's neoantigen vaccine candidate... El Paso Electric (EE), up 14% after announcing Infrastructure Investments Fund will purchase the company for $68.25 in cash per share representing an enterprise value of approximately $4.3B... Nektar (NKTR), up 4% after biomarker and clinical data from PIVOT-02 was presented at the American Society of Clinical Oncology. LOWER: Centene, down 8% after Humana disclosed that it will not propose a merger with the company... Alphabet (GOOGL), down 3% after the Wall Street Journal reported that the U.S. Department of Justice is preparing to open an investigation into Google's compliance with antitrust laws... FedEx (FDX), down 3% after Reuters reported China will investigate whether FedEx damaged the legal rights and interests of its clients after Huawei said parcels intended for it were diverted... Big Lots (BIG), down 4% after BofA/Merrill analyst Jason Haas double downgraded the stock to Underperform from Buy and cut his price target for the shares to $23 from $45... Infinera (INFN), down 4% after JPMorgan analyst Samik Chatterjee downgraded shares to Underweight from Neutral given a "heightened level of near-term and medium-term risks from the much more moderate level" of capex spending from cable customers.
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BPMC | Hot Stocks09:10 EDT Blueprint Medicines announces new data from ARROW trial of BLU-667 - Blueprint Medicines announced updated data from the ongoing registration-enabling ARROW trial of BLU-667 in patients with RET-altered cancers. The data presented at the American Society of Clinical Oncology 2019 Annual Meeting show durable clinical activity in patients with RET-altered non-small cell lung cancer, medullary thyroid cancer and other cancers. Designed by Blueprint Medicines, BLU-667 is a potent and highly selective oral inhibitor of RET fusions and mutations, including predicted resistance mutations. The new results support Blueprint Medicines' plans to submit an initial New Drug Application to the U.S. FDA for BLU-667 for the treatment of patients with RET-fusion NSCLC previously treated with platinum-based chemotherapy in the first quarter of 2020, and an NDA to the FDA for the treatment of patients with RET-mutant MTC previously treated with an approved multi-kinase inhibitor in the first half of 2020.
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GURE | Hot Stocks09:10 EDT Gulf Resources temporarily suspends trial production at Sichuan gas well - Gulf Resources announced the temporary suspension of trial production at its natural gas well in Daying County, Sichuan Province, China in order to comply with new environmental regulations being implemented in China. The company is required to obtain project approval for its well located in Daying, including the whole natural gas and brine water project, and approvals for safety production inspection, environmental protection assessment and to solve the related land issue. Until these approvals have been received, the company have to temporarily halt trial production at its natural gas well in Daying. Management has started discussions with local governmental officials about the oral notice. The company believes that the process that is now occurring in Sichuan Province is similar to the process that is occurring in Shandong Province. However, in this Sichuan case, management expects the process to be shorter and easier to accomplish. While many of the company's factories in Shandong were old and most of them were located near populous centers, all the machinery in Sichuan is new. From the beginning of the project, the company has been working closely with the Daying local governments to ensure the project and the equipment satisfy local requirements. In addition, the Daying well is located at a rural and mountainous area. The company does not believe it will encounter serious problems in meeting the new governmental requirements. It expects that this process could take approximately three months. At this time, the company cannot estimate potential costs in association with the compliance process. Until these approvals have been obtained, the company will not expect to apply for additional drilling permits. However, the company believes it remains highly committed to its Sichuan project.
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TM | Hot Stocks09:09 EDT Toyota's U.S. sales increased 3.2% in May, Bloomberg reports
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AQN | Hot Stocks09:08 EDT Algonquin Power to acquire Bermuda Electric Light Company for $365M - Algonquin Power & Utilities Corp. announced the execution of an implementation agreement with the Ascendant Group Limited pursuant to which APUC's international power and utilities investment platform, AAGES, is expected to acquire Ascendant and its subsidiaries . Ascendant, through its major subsidiary, Bermuda Electric Light Company, is the sole electric utility providing safe and reliable regulated electrical generation, transmission and distribution services to Bermuda. Under the terms of the all-cash transaction, which has been unanimously approved by the Board of Directors of each company, Ascendant's shareholders will receive $36.00 per common share, representing an aggregate share purchase price of approximately $365M. Transaction closing is expected to occur in late 2019, following receipt of shareholder and regulatory approvals.
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SVMK ADSK | Hot Stocks09:07 EDT SurveyMonkey names Autodesk executive Debbie Clifford as CFO - SurveyMonkey (SVMK) announced that Debbie Clifford will join its leadership team on July 8 as CFI In her new role, Clifford will oversee all aspects of finance including financial strategy, planning and analysis, accounting, tax, treasury, and investor relations, in addition to strategic planning and corporate development. With the addition of Clifford, the majority of SurveyMonkey's executive team members will be women. Clifford spent the past 13 years in several finance positions at design software company Autodesk (ADSK), most recently serving as vice president of financial planning and analysis.
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NH | Hot Stocks09:06 EDT NantHealth, NantOmics to present TMB data at ASCO - NantWorks announced that its affiliate companies, NantHealth and NantOmics will present data on the association between increased TMB and increased PD-L1 expression with the presence of SDH/FH mutations in a variety of tumors, using 3,461 paired tumor/normal whole exome sequences from the NantHealth clinical cases database to look into the potential therapeutic role for inhibition of PD-1/PD-L1 pathway in these tumors during the cancer prevention, hereditary genetics and epidemiology session at the ASCO 2019 Annual Meeting, an event bringing together more than 32,000 global oncology professionals from May 31-June 4, at McCormick Place in Chicago, Illinois. NantHealth and NantOmics conducted this study with researchers from Virginia Commonwealth University's Massey Cancer Center.
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GILD | Hot Stocks09:06 EDT Kite announces new Yescarta data from ZUMA-1 - Kite, a Gilead Company, announced findings from two new analyses from the ZUMA-1 trial of Yescarta in adult patients with relapsed or refractory large B-cell lymphoma. These results include a two-year sub-population analysis of efficacy and safety in ZUMA-1 patients by age, as well as preliminary data from a separate safety management study of patients receiving early steroid intervention for cytokine release syndrome and neurologic events. The results were presented at the 2019 American Society of Clinical Oncology Annual Meeting. Yescarta was the first CAR T cell therapy approved by the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Two-Year Analysis of ZUMA-1 by Age Supports Clinical Benefit of Yescarta in Patients 65 and Older: Patients with relapsed large B-cell lymphoma in the two-year follow-up of ZUMA-1 were analyzed in two groups - those 65 years or older and those younger than 65 years. With a median follow-up of 27.1 months, the objective response rate per investigator assessment was 92 percent among greater than or equal to65 patients and 81 percent in the less than65 group, with 75 percent and 53 percent of patients in the respective groups achieving a complete response. At two years, 42 percent of greater than or equal to65 patients and 38 percent of less than65 patients were in an ongoing response. The 24-month overall survival rate was 54 percent and 49 percent in each respective group. Among all patients in the safety analysis, most experienced Grade greater than or equal to3 adverse events. Grade greater than or equal to3 neurologic events occurred in 12 patients greater than or equal to65 and in 23 patients less than65. Grade greater than or equal to3 CRS occurred in 2 patients greater than or equal to65 and in 10 patients less than65. Kite is currently conducting various studies to further evaluate the efficacy and safety profile of Yescarta, including clinical trials evaluating use of bridging chemotherapy and other combination approaches. In a ZUMA-1 safety management study, patients with relapsed or refractory large B-cell lymphoma treated with Yescarta received earlier steroid intervention beginning when patients experienced Grade 1 neurologic events and at Grade 1 CRS when no improvement was observed after three days of supportive care. As of the abstract data cut-off, 21 of 40 planned patients had received Yescarta, with a median follow-up of 7.7 months; 76 percent of patients received corticosteroids and 86 percent received tocilizumab. Grade greater than or equal to3 adverse events occurred in 95 percent of patients; Grade greater than or equal to3 events included decreased neutrophil count and anemia. Grade 1 or 2 neurologic events and CRS occurred in 48 percent and 100 percent of patients, respectively. No patients experienced Grade greater than or equal to3 CRS, and Grade greater than or equal to3 neurologic events occurred in only 10 percent of patients, both numerically lower than in the registrational cohorts of ZUMA-1. There were no deaths due to adverse events in Cohort 4. ORR per investigator assessment was 81 percent in the cohort, and 62 percent of patients achieved a complete response. The median duration of response has not yet been reached.
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AQN | Hot Stocks09:06 EDT Algonquin Power to acquire Bermuda Electric Light Company for $365M
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CELG | Hot Stocks09:05 EDT Celgene announces updated analysis of data from Phase 2 JAKARTA2 clinical study - Celgene announced an updated analysis of data from the Phase 2 JAKARTA2 clinical study demonstrating clinically meaningful response rates with investigational fedratinib in patients with myelofibrosis previously treated with ruxolitinib. "This updated analysis of fedratinib employed intent-to-treat, or ITT, principles and utilized a narrower definition of ruxolitinib relapsed, refractory, or intolerant patients. Results were shared in a poster presentation today at the 2019 American Society of Clinical Oncology, or ASCO, Annual Meeting in Chicago. In the ITT population, the proportion of patients who exhibited a 35% or greater reduction in spleen volume at end of cycle 6 was 31%. Of these 97 patients, 79 met the narrower criteria for ruxolitinib resistance or intolerance. In this cohort, the proportion of patients who exhibited a 35% or greater reduction in spleen volume at end of cycle 6 was 30%, consistent with the response rate observed in the ITT population. In addition, the proportion of patients who exhibited a 50% or greater symptom response rate was 27% in both the ITT population and the patients in the analysis of the narrower criteria. The most common grade 3-4 hematologic abnormalities were anemia and thrombocytopenia. Most common non-hematologic treatment-emergent adverse events in all treated patients were diarrhea, nausea, vomiting, and constipation."
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TRUE | Hot Stocks09:04 EDT TrueCar announces retirement of CEO Chip Perry, Michael Darrow named interim CEO - TrueCar announced that Chip Perry, its President and CEO, has retired. TrueCar is planning for Perry to continue supporting the company in an advisory capacity. The Board has appointed Michael Darrow as interim President and CEO. Darrow is currently Executive Vice President of Partner & OEM Development and President of ALG.
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AMGN | Hot Stocks09:03 EDT Amgen: 5 patients experienced partial response in AMG 510 Phase 1 study - Amgen announced the first clinical results from a Phase 1 study evaluating investigational AMG 510, the first KRASG12C inhibitor to reach the clinical stage. In the trial, there were no dose-limiting toxicities at tested dose levels. AMG 510 showed anti-tumor activity when administered as a monotherapy in patients with locally-advanced or metastatic KRASG12C mutant solid tumors. These data are being presented during an oral session at the 55th Annual Meeting of the American Society of Clinical Oncology in Chicago. The Phase 1, first-in-human, open-label multicenter study enrolled 35 patients with various tumor types. Eligible patients were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumor type and stage of disease. The primary endpoint is safety, and key secondary endpoints include pharmacokinetics, objective response rate, duration of response and progression-free survival. Patients were enrolled in four dose cohorts - 180 mg, 360 mg, 720 mg and 960 mg, taken orally once a day. Five out of 10 evaluable patients with NSCLC experienced a partial response, and another four had stable disease, for a disease control rate of 90 percent. All five patients with response to therapy had a treatment duration of 7.3-27.4 weeks at data cutoff and remain active on treatment. One patient with PR improved further to a complete response of the target lesions at week 18, post data cutoff. In addition, 13 of 18 evaluable patients with CRC achieved SD, with the majority of CRC patients treated at the first two dose levels. Twenty-six patients remain on study and nine have discontinued. "KRAS has been a target of active exploration in cancer research since it was identified as one of the first oncogenes more than 30 years ago, but it remained undruggable due to a lack of traditional small molecule binding pockets on the protein. AMG 510 seeks to crack the KRAS code by exploiting a previously hidden groove on the protein surface," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "By irreversibly binding to cysteine 12 on the mutated KRAS protein, AMG 510 is designed to lock it into an inactive state. With high selectivity for KRASG12C, we believe investigational AMG 510 has high potential as both a monotherapy and in combination with other targeted and immune therapies."
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ZTO | Hot Stocks08:51 EDT ZTO Express says parcel volume exceeds 1B for first time in company history - ZTO Express announced its parcel volume of May exceeded 1B for the first time in its corporate history. Meisong Lai, Founder, Chairman and CEO of ZTO, commented, "Parcel volume of 1 billion is equivalent to the industry's total parcel volume in 2006 or our total parcel volume in 2013, which is a significant achievement. We also hit another record starting in March 2019 with daily parcel volume reaching 30 million leading up to this milestone. ZTO will continue to generate high-quality growth, empower its network partners, and drive the industry forward."
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DMPI | Hot Stocks08:49 EDT DelMar Pharmaceuticals provides update on VAL-083 studies - DelMar Pharmaceuticals presented clinical updates from the company's ongoing first- and second-line trials in patients with MGMT-unmethylated glioblastoma multiforme at a key opinion leader forum focused on brain tumors and the role of VAL-083 to address the unmet medical need in GBM during the 2019 American Society of Clinical Oncology annual meeting in Chicago, IL. At the KOL forum, the company provided an update on the ongoing Phase 1/2 clinical study investigating the front line treatment of VAL-083 with radiation therapy in newly diagnosed MGMT-unmethylated GBM. This trial is being conducted at the Sun Yat-sen University Cancer Center in Guangzhou, China in collaboration with Guangxi Wuzhou Pharmaceutical Company. The trial is designed to enroll up to 30 patients to determine if first-line therapy with VAL-083 treatment, in lieu of first-line temozolomide, improves progression free survival. As of May 17, eighteen patients have been enrolled in the trial. Of these patients, fifteen have received their post-cycle 3 MRI and investigator assessment, and ten have received their post-cycle 7 MRI and investigator assessment. Two patients have not been on the study long enough to reach their first assessment, and one patient died before their first assessment. Assessments are based on the trial investigator's clinical and radiologic assessment, according to the Response Assessment in NeuroOncology (RANO) criteria. For the fifteen patients who have received at least one assessment, eight patients were assessed with a best response of "Complete Response" (8/15, 53.3% CR) and seven patients were assessed with a best response of "Stable Disease" (7/15, 46.7% SD). Fourteen of the eighteen patients were still alive at the data cut-off date. The company also provided an update on the ongoing second-line Phase 2 clinical study of VAL-083 in patients with MGMT-unmethylated, Bevacizumab-naive recurrent GBM. This study is being conducted in collaboration with The University of Texas MD Anderson Cancer Center. This biomarker-driven trial has been amended to enroll up to 83 patients (35 with a starting dose of 40 mg/m2; 48 with a starting dose of 30 mg/m2) to determine the potential of VAL-083 treatment to improve overall survival compared to historical reference control of 7.2 months with lomustine. As of May 5, 51 patients have been enrolled, 35 patients at a starting dose of 40 mg/m, and 16 patients at a starting dose of 30 mg/m. For the 47 patients who have been on study long enough to be assessed at the post-cycle 2 MRI: 9/35 (25.7%) patients initially receiving 40 mg/m exhibited "Stable Disease" per investigator assessment at the end of cycle 2; 4/12 (33.3%) patients initially receiving 30 mg/m2 exhibited "Stable Disease" per investigator assessment at the end of cycle 2. Consistent with prior studies, myelosuppression is the most common adverse event in both ongoing clinical trials.
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AGLE | Hot Stocks08:49 EDT Aeglea BioTherapeutics doses first patient in Phase 3 PEACE trial - Aeglea BioTherapeutics announced the dosing of the first patient in the company's Phase 3 PEACE clinical trial. The pivotal trial is intended to further evaluate the efficacy and safety of pegzilarginase for the treatment of Arginase 1 Deficiency, or ARG1-D, a progressive disease presenting in early childhood that results in severe complications and early mortality. The company expects to report topline data from the PEACE trial in Q1 of 2021. Aeglea anticipates reporting new data in September from all patients who have each received at least 20 doses in the company's ongoing Phase 1/2 extension study.
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NTRA | Hot Stocks08:44 EDT Natera's Signatera test detects immunotherapy treatment response in new study - A new study demonstrates the ability of Natera's Signatera test to assess patient response to immunotherapy in the metastatic setting across multiple cancer types by detecting molecular traces of circulating tumor DNA in the blood. The study was presented at the American Society of Clinical Oncology Annual Meeting in Chicago on June 1. The study, conducted by Princess Margaret Cancer Centre in Toronto, enrolled 70 patients with advanced cancer, including head and neck, triple-negative breast, melanoma, and ovarian cancers. Patients were treated with the single-agent immune checkpoint inhibitor pembrolizumab as part of the phase II INSPIRE trial. The study used Signatera to assess ctDNA at baseline and again at the start of the third treatment cycle. Results showed a strong correlation between changes in ctDNA and overall survival, progression-free survival, and overall clinical response rate, illustrating that ctDNA may be a valuable predictive biomarker for patients with mixed solid tumors treated with checkpoint inhibitors. Signatera, a personalized, tumor-informed blood test, detected ctDNA in 68 out of 70 patients at baseline (97% sensitivity).
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SLS | Hot Stocks08:44 EDT Sellas Life Sciences announces results from trastuzumab +/- NPS trial at ASCO - Sellas Life Sciences announced results from a preplanned analysis of immunologic responses in the cohort of patients with triple negative breast cancer, or TNBC, from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial of nelipepimut-S, or NPS, +/- trastuzumab targeting HER2 low-expressing breast cancer patients. This analysis was presented at the American Society of Clinical Oncology, or ASCO. The Phase 2b study enrolled patients with HER2-low expressing breast cancer who remained clinically disease-free after completion of frontline standard of care therapy. Patients were selected to harbor node-positive disease and/or TNBC, as well as expressing human leukocyte antigen, or HLA, types indicated for NPS administration. Patients were randomized to placebo with granulocyte-macrophage colony-stimulating factor or NPS with GM-CSF, while they all received trastuzumab every 3 weeks for one year. The company previously reported results of the final analysis of efficacy and safety outcomes in the cohort of patients whose tumors did not express hormone receptors. DFS of patients treated with NPS plus trastuzumab was 92.6% compared to 70.2% for those treated with trastuzumab alone and represented a clinically meaningful and a statistically significant improvement with the combination therapy. This was associated with a statistically significant reduction by 71.9% in the frequency of clinically detected recurrences in favor of the combination in the TNBC cohort. Ninety-one of the 97 TNBC patients in this clinical study were analyzed for immune responses, or IR, at five timepoints, 51 of whom received the combination therapy. IR were evaluated ex vivo by clonal expansion of antigen NPS-specific cytotoxic T-lymphocytes, or CTL, by dextramer-staining/flow cytometry at predefined time points over three years. In vivo IR were assessed by cutaneous delayed type hypersensitivity, or DTH, reactions periodically, by measuring the diameter of skin induration post intradermal NPS treatment. NPS plus trastuzumab-treated TNBC patients exhibited increases in CTL frequencies compared with baseline. The mean CTL frequencies in these patients increased at baseline at a 2.86-fold difference that was clinically indicative, as compared with patients receiving trastuzumab only. Three patients in the combination arm recurred as compared with 12 in the trastuzumab-alone arm. TNBC patients treated with NPS plus trastuzumab whose disease recurred did not mount an IR by ex vivo assessment or by in vivo DTH, while non-recurrent patients mounted both vigorous NPS-specific clonal CTL expansion and enhanced in vivo DTH.
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JAX | Hot Stocks08:39 EDT Ancora Advisors urges J. Alexander's holders to withhold votes at Annual meeting - Ancora Advisors, which beneficially owns approximately 8.76% of the outstanding shares of J. Alexander's Holdings, making it one of the company's largest shareholders, announced that it has filed definitive proxy materials with the SEC. The definitive proxy materials urge J. Alexander's shareholders to use the GOLD proxy card to WITHHOLD their votes from the election of Timothy Janszen and Ronald Maggard to the Board of Directors of J. Alexander's at the 2019 Annual Meeting of Shareholders scheduled to be held on June 20. In connection with the filing of its definitive proxy materials, Ancora issued a letter urging shareholders to send a clear message to the J. Alexander's Board that the status quo is unacceptable and that the Board should immediately engage with Ancora on its proposal to acquire the company for $11.75 per share in cash or otherwise run a strategic process focused on the sale of the company. Ancora also issued a detailed investor presentation outlining the reasons for its withhold campaign. Reference Link
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FTSV | Hot Stocks08:38 EDT Forty Seven announces updated data on 5F9 with azacitidine trial at ASCO - Forty Seven announced updated initial data from its Phase 1b clinical trial evaluating 5F9 as a monotherapy and in combination with azacitidine for the treatment of myelodysplastic syndrome, or MDS and acute myeloid leukemia, or AML. The data, which have matured since the abstract submission and now include additional patients and longer-term follow-up, will be presented in a poster discussion session at ASCO. Forty Seven's Phase 1b trial, which is being funded in part by the California Institute for Regenerative Medicine, or CIRM, is designed to evaluate 5F9 as a monotherapy in patients with relapsed or refractory MDS or AML, and 5F9 in combination with azacitidine in higher-risk MDS patients and untreated, induction chemotherapy-ineligible AML patients. All patients received a 1 mg/kg priming dose of 5F9, coupled with intrapatient dose escalation, to mitigate on-target anemia. Patients in the combination cohort were then treated with full doses of azacitidine and a 5F9 maintenance dose of 30 mg/kg once weekly. As of the data cutoff of May 10, 46 patients had been treated in the Phase 1b portion of the trial, including 10 r/r MDS or AML patients who received monotherapy 5F9, and 36 untreated higher-risk MDS patients or untreated AML patients ineligible for induction chemotherapy, who received 5F9 in combination with azacitidine. As of the data cutoff, 5F9 was well-tolerated both as a monotherapy and in combination with azacitidine, with no evidence of increased toxicities compared to azacitidine alone. Adverse events, or AEs, were consistent with what has been previously seen with 5F9, and no significant cytopenias or autoimmune-related AEs were observed in patients treated with monotherapy 5F9. Overall, the most commonly reported treatment-related AEs were expected CD47-mechanism-based effects on red blood cells, which led to a temporary and reversible anemia, and many patients in the combination cohort experienced a hemoglobin improvement over the course of their treatment with a decrease in transfusions. Importantly, no treatment-related infections were observed, and only one patient out of 36 treated with the combination experienced neutropenic fever. No deaths were observed in the first 60 days on combination treatment. Only one patient out of 46 discontinued treatment due to a treatment-related AE. As of the data cutoff, 35 patients were evaluable for response assessment, including 25 patients with untreated higher-risk MDS or AML who were treated with 5F9 and azacitidine and 10 patients with r/r MDS or AML who were treated with monotherapy 5F9. In higher-risk MDS, the overall response rate, or ORR, for the combination was 100%, with six patients achieving a complete response, or CR, four patients achieving a marrow CR and one patient achieving hematologic improvement. In untreated AML, the ORR for the combination was 64%, with five patients achieving a CR, two patients achieving a complete response with incomplete blood count recovery and two patients achieving a morphologic leukemia-free state. Additionally, five patients achieved stable disease. In r/r MDS or AML treated with monotherapy 5F9, the ORR was 10%, consisting of one patient who achieved a MLFS. Additionally, seven patients achieved SD. The median time to response among MDS and AML patients treated with the combination was 1.9 months. Six patients receiving the combination who had an objective response have experienced deepening responses over time resulting in complete remissions. Five patients have also successfully received allogeneic stem cell transplants. Historical response rates for single-agent azacitidine, show CR rates of approximately 15%-20% in higher-risk MDS and untreated AML patients, with initial responses generally occurring after 4-6 months in most patients who respond. Based on the safety profile and clinical activity observed in this Phase 1b clinical trial to-date, expansion cohorts have been initiated in patients with both higher-risk MDS and untreated AML with 5F9 in combination with azacitidine. Additionally, based on feedback from a Type B meeting with the FDA in May, Forty Seven believes that data from a single arm pivotal study evaluating durability, CRs and partial responses may be sufficient to support the registration of 5F9 in combination with azacitidine in patients with untreated, higher-risk MDS. The company is currently finalizing the operational components of the proposed registrational study, including details on trial design and chemistry, manufacturing and controls and will provide a detailed update in the second half of 2019.
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OSIS | Hot Stocks08:37 EDT OSI Systems awarded service contract valued up to $5M - OSI Systems announced that its Security division was awarded a multi-year U.S. state contract, valued at up to approximately $5M, to provide comprehensive service and maintenance support for Rapiscan baggage and parcel checkpoint inspection systems installed at correctional facilities and detection centers.
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WTM | Hot Stocks08:37 EDT White Mountains makes minority investment in Elementum Advisors - White Mountains Insurance Group announced that it has acquired a minority equity stake in Elementum Advisors, an SEC-registered investment advisor focused on managing investment portfolios exposed to natural catastrophe event risk. The terms were not disclosed. White Mountains will also invest $50M across Elementum's funds. Elementum's principals continue to own a significant majority of Elementum and will control the operation of the business following this transaction.
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CUBI | Hot Stocks08:35 EDT Customers Bancorp holders approve 'say on pay' proposal at annual meeting - Shareholders of Customers Bancorp met at the Doubletree by Hilton Hotel in Reading, Pennsylvania on Thursday, May 30 and "affirmed their support of corporate leadership with approval and adoption of a non-binding 'say on pay' proposal, the company's 2019 stock incentive plan, and approval of an amendment to the company's Articles of Incorporation to adopt a majority voting standard in uncontested elections of directors." The non-binding "say on pay" proposal outlining the company's executive compensation program and compensation paid to the company's named executive officers was adopted with approximately 95% shareholder approval. "The proposal is not binding on the corporation, notes the proxy statement, but the board and Compensation Committee value the opinions of shareholders and will continue an outreach program and the study of best practices in considering future executive compensation."
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TRQ | Hot Stocks08:35 EDT Turquoise Hill names Jo-Anne Dudley as COO, effective June 3 - Turquoise Hill Resources announced the appointment of Jo-Anne Dudley as COO, effective June 3rd. Dudley has 25 years of experience in the mining industry. For the past nine years she has been a key member of the Oyu Tolgoi technical team that manages the development of the world-scale Oyu Tolgoi copper-gold mine in Mongolia in consultation with Turquoise Hill.
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ARE | Hot Stocks08:33 EDT Alexandria Real Estate raises quarterly dividend 3% to $1.00 per share - The dividend is payable on July 15 to shareholders of record on June 28.
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IRWD AGN | Hot Stocks08:33 EDT Ironwood, Allergan initiate dosing in Phase II clinical trial of MD-7246 - Ironwood Pharmaceuticals (IRWD) announced the initiation of patient dosing in a Phase II clinical trial evaluating MD-7246 in patients with abdominal pain associated with irritable bowel syndrome with diarrhea. Data from the Phase II trial are expected in the second half of 2020. Ironwood and Allergan (AGN) are evaluating MD-7246, an investigational new product, as an oral, intestinal, non-opioid, pain-relieving agent for patients suffering from abdominal pain associated with certain GI diseases. MD-7246 is a delayed-release formulation of linaclotide designed to provide targeted delivery of linaclotide to the colon, where the majority of the abdominal pain associated with IBS-D is believed to originate, and to limit fluid secretion in the small intestine resulting in minimal impact on bowel function.
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LNG | Hot Stocks08:32 EDT Cheniere Energy revises distributable cash flow per share $8.40-$9.60 - Incorporating the impact of Sabine Pass Train 6 and increased run-rate production guidance, Cheniere has revised its run-rate financial guidance as follows: Consolidated Adjusted EBITDA $5.2 - $5.6B and Distributable Cash Flow per share $8.40 - $9.60.
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UTX | Hot Stocks08:32 EDT United Technologies names CEOs for Carrier, Otis - United Technologies announced the appointments of David Gitlin as president & CEO of Carrier and Judith Marks as president & CEO of Otis, effective immediately. Gitlin most recently served as president and COO of Collins Aerospace. Judith Marks joined United Technologies as president of Otis in 2017 from Siemens, where she served as CEO of Siemens USA and Dresser-Rand, a Siemens business. Previously, she held senior leadership roles at Lockheed Martin and IBM.
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HEI | Hot Stocks08:31 EDT Heico acquires Research Electronics International, terms not disclosed - Heico announced that its Electronic Technologies Group acquired 75% of the ownership of Cookeville, TN-based Research Electronics International in an all cash transaction. REI's two owners/managers retained the remaining 25% ownership. No further financial details were disclosed. Heico expects the acquisition to be accretive to its earnings within the first 12 months after closing.
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LNG | Hot Stocks08:31 EDT Cheniere raises run-rate production guidance to 4.7-5 mtpa per Train - Cheniere has also raised its run-rate production guidance to 4.7 - 5.0 mtpa per Train, up from 4.4 - 4.9 mtpa per Train. The increase in run-rate production is based on the impact of production optimization, maintenance optimization, and debottlenecking projects at both the SPL Project and CCL Project.
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LNG CQP | Hot Stocks08:29 EDT Cheniere announces Sabine Pass Train 6 final invesment decision - Cheniere's (LNG) subsidiary Cheniere Energy Partners (CQP) announced that the Board of Directors of its general partner has made a positive FID with respect to Train 6 of the Sabine Pass Liquefaction Project in Cameron Parish, Louisiana, and Cheniere Partners has issued full notice to proceed with construction to Bechtel Oil, Gas and Chemicals. To fund a portion of the construction of Train 6 and a third LNG berth and required supporting infrastructure at the SPL Project, Cheniere Partners has entered into 5-year, $1.5B senior secured credit facilities with 29 banks and financial institutions in a transaction that closed on May 29, 2019. The facilities include a $750M delayed draw term loan, and a $750M revolving credit facility. SG Americas Securities, LLC acted as Financial Advisor to Cheniere Partners for the transaction, and MUFG Bank, Ltd acted as Sole Coordinating Lead Arranger.
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LNG | Hot Stocks08:27 EDT Cheniere Energy expects to generate over $9B available cash through 1H24 - Cheniere Energy announced that its Board of Directors has approved a comprehensive capital allocation framework for the company that prioritizes reinvestment of cash flows to grow Cheniere's LNG platform, achievement of improved credit metrics for the company's liquefaction project entities and on a consolidated basis, and return of excess capital to shareholders through a framework that provides the Company flexibility to adapt to changes in growth opportunities and market conditions. Cheniere expects to generate over $9B of available cash through the first half of 2024. The capital allocation framework provides for the following allocation through the forecast period of approximately five years: Growth Investments - Reinvest cash flows to fund accretive projects using at least 50% equity funding, Sabine Pass Train 6 - Over 50% equity investment, Corpus Christi Stage 3 - At least 50% equity investment for expansion project adjacent to the Corpus Christi Liquefaction Project with total expected nominal production of approximately 9.5 million tonnes per annum, for which a positive Final Investment Decision is expected as early as 2020. Debottlenecking Projects - capital investments to increase production of existing liquefaction platform Balance Sheet - Ensure resiliency of investment grade ratings at liquefaction project entities and move toward an investment grade corporate rating for Cheniere. Leverage - proactively reduce consolidated debt and achieve an investment grade debt to Consolidated Adjusted EBITDA ratio. Capital Return - Platform that enables meaningful capital return to shareholders while maintaining flexibility for Cheniere/ Share Repurchase Authorization - 3-year, $1B share repurchase authorization approved by Cheniere's Board of Directors.
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LNG APA | Hot Stocks08:24 EDT Cheniere Corpus Christi Stage III, Apache sign long-term gas supply agreement - Cheniere Energy (LNG) announced that its subsidiary, Cheniere Corpus Christi Liquefaction Stage III, has entered into a long-term gas supply agreement with Apache Corporation (APA). Under the GSA, Apache has agreed to sell 140,000 MMBtu per day of natural gas to Corpus Christi Stage III for a term of approximately 15 years. The LNG associated with this gas supply, approximately 0.85 million tonnes per annum, will be marketed by Cheniere. Apache will receive an LNG price, net of a fixed liquefaction fee and certain costs incurred by Cheniere, for the natural gas delivered to Corpus Christi Stage III under this agreement. The LNG price is based on international LNG indices. The Corpus Christi Stage III project is being developed to include up to seven midscale liquefaction trains with a total expected nominal production capacity of approximately 9.5 mtpa. Corpus Christi Stage III received a positive Environmental Assessment from the Federal Energy Regulatory Commission in March 2019 and is expected to receive all remaining necessary regulatory approvals for the project by the end of 2019.
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TMDX | Hot Stocks08:24 EDT TransMedics receives PMA approval from FDA for OCS Lung system - TransMedics announced that it has received an FDA PMA approval for expanded clinical indications of the Organ Care System, or OCS, Lung. This approval will enable the OCS Lung System to be used for the preservation and ex-vivo assessment of both standard criteria donor lungs as well as the larger pool of donor lungs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation. This approval will also enable the OCS Lung System to be used with both donors after brain death, or DBD, and donors after circulatory death, or DCD. Prior to this latest FDA approval, the OCS Lung System was approved for standard criteria lungs from DBD donors only. Based on this FDA PMA approval, TransMedics will expand its post-market thoracic organ perfusion registry to collect long-term post-market data from recipients of all OCS Lung preserved standard criteria and initially deemed unacceptable donor lungs.
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ATI | Hot Stocks08:24 EDT Allegheny Technologies announces sale of 2 non-core forging facilities for $37M - Allegheny Technologies announced that it has agreed to sell two non-core forging facilities to Wynnchurch Capital for $37M in cash. Wynnchurch Capital, based in Chicago, IL, is a leading middle-market private equity investment firm that invests in middle market companies in the United States and Canada which possess the potential for substantial growth and operational improvement. The transaction will close during Q2.
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CQP | Hot Stocks08:22 EDT Cheniere Partners raises run-rate distributable cash flow per unit guidance - Incorporating the impact of Sabine Pass Train 6 and increased run-rate production guidance, Cheniere Partners has revised its run-rate distributable cash flow per unit guidance to $3.70 - $3.90 annually, up from $3.30 - $3.60 annually.
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ESEA | Hot Stocks08:22 EDT Euroseas announces refinancing of two vessels, acquisition of four vessels - Euroseas announced its entry into three material transactions: the refinancing of two of its vessels with simultaneous interest rate reduction for all other existing loans; the redemption of approximately 60% of its outstanding Series B Preferred Shares with simultaneous reduction of the dividend rate for the preferred shares remaining outstanding; and, the signing of memoranda of agreement to acquire four vessels for a combination of cash and common shares. Euroseas believes that the combined effect of these transactions will be to reduce its interest and preferred dividend expenses by approximately $1.4M per year as well as its overall leverage of combined debt and preferred equity. Euroseas agreed to refinance two of its vessels in a transaction that freed up about $8M of cash which together with approximately $3.7M of its available cash will be used to redeem approximately $11.7M of its series B Preferred Shares as described below. Following this refinancing, all of Euroseas' existing vessels are financed by the same bank, which as part of the arrangement agreed to reduce the loan margin of the overall loan facility by 0.5%. Euroseas also announced that it signed memoranda of agreement to acquire four feeder containerships for a consideration that includes a cash payment of $15M and issuance of approximately 22.5 million shares of common stock to the sellers. Euroseas intends to finance the cash portion of the acquisition price with bank debt which will be used to repay the existing indebtedness of the vessels with the sellers receiving only payment in Euroseas common shares. The common shares to be issued to the sellers will represent approximately 64.3% of Euroseas' outstanding common shares. The vessels are owned by affiliates of the Pittas family, controlled by the Company's CEO. As a result, the transactions have been evaluated and approved by a special committee of independent members of the Euroseas Board of Directors. The newly acquired vessels will be delivered to the Company within the next two months.
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VCNX | Hot Stocks08:21 EDT Vaccinex announces interim results of pepinemab with avelumab study at ASCO - Vaccinex announced that updated interim results of the Phase 1b/2 study of pepinemab in combination with avelumab in non-small cell lung cancer, or NSCLC, subjects were reported during a poster session at the American Society of Clinical Oncology, or ASCO. This ongoing Phase 1b/2, open label, single arm, first-in-human combination study is designed to evaluate the safety, tolerability and efficacy of pepinemab in combination with avelumab in 62 subjects with advanced NSCLC. The trial is split into dose escalation and dose expansion phases. The dose escalation phase, in which 12 subjects were enrolled, is complete and the recommended Phase 2 dose of the combination was selected as 10mg/kg pepinemab in combination with 10mg/kg avelumab, both administered intravenously once every two weeks. The dose expansion phase of the study is ongoing and includes two cohorts: 17 subjects who are immunotherapy naive and up to 33 subjects whose tumors will have progressed during or following prior immunotherapy. The combination of pepinemab and avelumab has been well-tolerated and no concerning safety signals have been identified to date. One DLT, a grade 3 pulmonary embolism, occurred in the 10mg/kg pepinemab + 10mg/kg avelumab escalation cohort, resolved and did not recur in that same subject or additional subjects in any cohort. In addition, there have been no drop-outs or discontinuations due to toxicity. Among the 16 evaluable subjects to date who received prior immunotherapy, five had been treated with pembrolizumab or nivolumab for six to 18 months before progression, of whom 2 had partial responses and 2 had stable disease after receiving combination therapy with pepinemab and avelumab. An additional 9 subjects had prior immunotherapy for three to six months before progression, of whom five had stable disease and four continued progressing after receiving the combination of pepinemab and avelumab. Exploratory biomarker immunohistochemical analysis demonstrated increased CD8+ T cell influx into tumors and increased T effector / T regulatory ratio following combination therapy, suggesting a favorable immuno-phenotype in the tumor micro-environment. Tumor was absent or reduced in biopsies from the 2 subjects who had partial responses, and no tumor was evident in biopsies from 3 of 4 subjects with stable disease, as defined by RECIST criteria.
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ANFI | Hot Stocks08:21 EDT Amira Nature Foods Brian Speck as CFO - Amira Nature Foods announced the hiring of Brian Speck as CFO. Since March 2018, Speck has been the CFO of Surge Holdings.
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CQP | Hot Stocks08:20 EDT Cheniere Energy Partners raises run-rate production guidance to 4.8-4.9 mtpa - Cheniere Partners has also raised its run-rate production guidance to 4.8 - 4.9 million tonnes per annum per Train, up from 4.5 - 4.9 mtpa per Train. The increase in run-rate production is based on the impact of production optimization, maintenance optimization, and debottlenecking projects at the SPL Project.
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AWR | Hot Stocks08:19 EDT American States Water says CPUC approves new water rates - American States Water announced that on May 30, the California Public Utilities Commission, or CPUC, approved the water general rate case for AWR's wholly owned subsidiary, Golden State Water Company, or GSWC. GSWC had filed a general rate case application in July 2017 for all of its water regions and the general office to determine new rates for the years 2019 - 2021. The new rates approved by the CPUC are retroactive to January 1, 2019. Among other things, the final decision approves a settlement agreement in its entirety that had been entered into in August 2018 between GSWC and the CPUC's Public Advocates Office. As a result, the final decision authorizes GSWC to invest approximately $334.5 million over the rate cycle in order to continue to provide safe and reliable water utility service to its customers. The $334.5 million of infrastructure investment includes $20.4 million of capital projects to be filed for revenue recovery through advice letters when those projects are completed. In April 2019, the assigned Administrative Law Judge had issued a proposed decision approving the settlement agreement with the exception of these advice letter projects. However, in the final decision, the CPUC adopted a revised proposed decision which was modified to approve the initial settlement as filed, including all of the advice letter capital projects agreed to by GSWC and the Public Advocates Office. Excluding the advice letter project revenues, the new rates approved will increase the water gross margin for 2019 by approximately $7.1 million, adjusted for updated inflation index values since the August 2018 settlement, as compared to the 2018 adopted water gross margin. The 2019 water revenue requirement has been reduced to reflect a decrease of approximately $7 million in depreciation expense, compared to the adopted 2018 depreciation expense, due to a reduction in the overall composite depreciation rates based on a revised study filed in the general rate case. The decrease in depreciation expense lowers the water gross margin, and is offset by a corresponding decrease in depreciation expense, resulting in no impact to net earnings. In addition, the 2019 water revenue requirement includes a decrease of approximately $2.2 million for excess deferred tax refunds as a result of the 2017 Tax Cuts and Jobs Act, which has a corresponding decrease in income tax expense and also results in no impact to net earnings. Had depreciation expense remained the same as the 2018 adopted amount and there were no excess deferred tax refunds that lowered the 2019 revenue requirement, the water gross margin for 2019 would have increased by approximately $16.3 million. Due to the delay in receiving a final decision by the CPUC, billed water revenues to date have been based on 2018 adopted rates. Had new rates been in place as of January 1, pretax income for the water segment would have been higher by approximately $4 million, or 8c per share, for the first quarter of 2019. Because the new rates are retroactive to January 1, this cumulative impact will be recorded during the second quarter of 2019. In addition, the final decision approves the recovery of previously incurred costs that were being tracked in CPUC-authorized memorandum accounts, which will result in a reduction to operating expenses of approximately $1 million, or 2c per share, also to be recorded during the second quarter. Excluding the advice letter project revenues, the final decision allows for potential additional water revenue increases in 2020 and 2021 of approximately $9.6 million and $12 million, respectively, subject to the results of an earnings test and changes to the forecasted inflationary index values.
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CQP | Hot Stocks08:17 EDT Cheniere Energy Partners makes positive final investment decision on Train 6 - Cheniere Energy Partners announced that the Board of Directors of its general partner has made a positive Final Investment Decision with respect to Train 6 at the Sabine Pass liquefaction project in Cameron Parish, Louisiana, and Cheniere Partners has issued full notice to proceed with construction to Bechtel Oil, Gas and Chemicals. To fund a portion of the construction of Train 6, a third LNG berth, and required supporting infrastructure at the SPL Project, Cheniere Partners has entered into 5-year, $1.5B senior secured credit facilities with 29 banks and financial institutions in a transaction that closed on May 29, 2019. The facilities include a $750M delayed draw term loan and a $750M revolving credit facility. SG Americas Securities, LLC acted as financial advisor to Cheniere Partners for the transaction, and MUFG Bank, Ltd. acted as Sole Coordinating Lead Arranger.
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ETSY GRUB | Hot Stocks08:17 EDT Etsy names Ryan Scott Chief Marketing Officer, effective June 24GrubHub - Etsy (ETSY) has named Ryan Scott Chief Marketing Officer, effective June 24. Formerly CMO of Slice, the leading digital marketplace for pizza ordering, Scott has nearly two decades of marketing and e-commerce experience, including leadership roles at Grubhub (GRUB), SoulCycle, and Pond5. In this newly-created position, Scott will have global responsibility for the company's digital marketing, advertising, brand, communications, and market research and international growth initiatives, as Etsy scales its brand and performance marketing operations. He will be based at Etsy's headquarters in Brooklyn, NY and report to CEO Josh Silverman.
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INFN | Hot Stocks08:17 EDT Infinera appoints Sharon Holt to board, increases board size to nine - Infinera announced the appointment of Sharon Holt to its board of directors, effective immediately. Holt brings to the board experience in the global semiconductor industry and an track record of sales and field operations. Holt has served as a principal at Fraser Stuart Ventures, a private investment and advisory firm since 2016.
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MCC | Hot Stocks08:15 EDT NexPoint urges Medley Capital holders to vote for nominees using blue proxy card - NexPoint reminds Medley Capital stockholders to vote for nominees Stephen Mongillo and Mark Goglia using BLUE proxy cards.
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OPI | Hot Stocks08:14 EDT Office Properties announces sale of 2 properties - Office Properties announced that it has sold two properties for an aggregate sales price of $21.9M, excluding closing costs. The two properties include: A six-story, 121,711 square foot office building located at 138 Delaware Avenue in Buffalo, NY. A three-story, 287,037 square foot vacant office building located at 111 Powdermill Road in Maynard, MA. The sales proceeds will be used for general corporate purposes, including the repayment of amounts outstanding on the company's unsecured term loan.
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VBLT | Hot Stocks08:14 EDT VBL Therapeutics presents final VB-111 trial results at ASCO - VBL Therapeutics announced the presentation of the final results from a Phase 1/2 clinical trial of VB-111 in the treatment of patients with recurrent platinum resistant ovarian cancer at the American Society of Clinical Oncology, or ASCO, annual meeting. Data demonstrated a median overall survival, or OS, of 498 days in the VB-111 therapeutic-dose arm, versus 172.5 days in the low-dose arm. Overall, 58% of evaluable patients treated with the therapeutic dose of VB-111 had a GCIG CA-125 response. In comparison, in the AURELIA trial, the GCIG CA-125 response rate was 31.8% with bevacizumab and chemotherapy, and only 11.6% with chemotherapy alone. VB-111 activity signals were seen despite unfavorable prognostic characteristics. There was a trend for favorable survival in patients who had CA-125 decrease greater than 50% in the VB-111 therapeutic-dose arm implicating CA-125 as a valuable biomarker for response to VB-111. Post treatment fever was also associated with a signal for improved survival.
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CLI | Hot Stocks08:12 EDT Mack-Cali Realty urges holders to vote 'FOR' all nominees on White proxy card - Mack-Cali Realty issued the following statement in response to the reports issued by Institutional Shareholder Services and Glass Lewis & Co. in connection with the election of directors to Mack-Cali's Board of Directors at the company's 2019 Annual Meeting of Stockholders, scheduled for June 12: "Mack-Cali strongly disagrees with ISS's and Glass Lewis' recommendations to vote on the gold proxy card for some of the director candidates nominated by Bow Street Special Opportunities Fund XV, LP. The company continues to urge stockholders to protect their investment by voting the WHITE proxy card "FOR ALL" of its 11 highly qualified director nominees: William Mack, Nathan Gantcher, Alan Philibosian, Vincent Tese, Alan Bernikow, Michael DeMarco, Davis Mack, Lisa Myers, Laura Pomerantz, Irvin Reid and Rebecca Robertson."
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RILY | Hot Stocks08:11 EDT B. Riley FBR names Jimmy Baker head of capital markets - B. Riley FBR announced that James "Jimmy" Baker has been promoted to Head of Capital Markets. Baker will continue to serve as Executive Vice President of Brokerage and take on an expanded role overseeing the firm's extensive capital markets platform.
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WSTG | Hot Stocks08:11 EDT Wayside Technology subsidiary enters distribution agreement with Garland - Lifeboat Distribution, a subsidiary of Wayside Technology, announced a new distribution agreement with Garland Technology, a provider of network test access point, or TAPs, and packet broker solutions. Lifeboat will sell Garland Technology's complete line of TAPs to enterprises, service providers and government agencies within North America, enabling data centers to address IT challenges and gain complete network visibility.
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OTLK... | Hot Stocks08:10 EDT Outlook Therapeutics signs manufacturing supply agreement with Fujifilm Diosynth - Outlook Therapeutics (OTLK) announced that it has signed a master services agreement with FUJIFILM Diosynth Biotechnologies (FUJIY, MSBHY) for the production of ONS-5010. Under the terms of this agreement, FDB will provide global manufacturing of ONS-5010 to Outlook in support of the commercialization strategy for the drug. Additional terms of the agreement were not disclosed. "Our master services agreement with FDB secures a world class manufacturing facility for the potential commercial launch of ONS-5010. Most importantly, FDB has the ability to rapidly scale manufacturing of ONS-5010 while maintaining the quality controls that meet or exceed regulatory requirements," said Terry Dagnon, COO at Outlook Therapeutics, Inc. "Identifying a highly-regarded manufacturing partner for ONS-5010 is an important part of our commercialization strategy and is a required part of the Biologics License Application, or BLA, submission in wet AMD." Outlook Therapeutics is currently conducting two Phase 3 clinical studies for ONS-5010. If successful, these studies will support the Company's plan to submit for regulatory approval in multiple markets in 2020. ONS-5010, if approved, has potential to mitigate risks associated with off-label use of Avastin or other drugs. Off-label use of Avastin is currently estimated to account for at least 50% of all wet AMD prescriptions in the United States.
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ETR | Hot Stocks08:09 EDT Entergy's Pilgrim Nuclear Power Station shut down permanently - Control room operators at Entergy's Pilgrim Nuclear Power Station, located in Plymouth, Massachusetts, shut down its reactor for the final time on Friday, at 5:28 p.m. The decision to shut down Pilgrim was the result of a number of financial factors, including low wholesale energy prices. As part of its employee commitment at Pilgrim, the company previously announced its plan to find a position within Entergy for those qualified employees who were willing to relocate. Currently, more than 50 employees from Pilgrim have accepted offers to continue with the company in other locations.
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KYO | Hot Stocks08:09 EDT Kyocera enters collaboration with BYD Japan - Kyocera and BYD Japan, the Japanese arm of China's BYD, announced a joint project to develop an integrated renewable supply-demand energy system for EVs. "By combining renewable energy from Kyocera's solar power generating systems and BYD's electric buses, the collaboration will maximize the effectiveness of renewable energy, greatly reduce power losses, and maintain a stable supply-demand energy balance. For this project, Kyocera will develop the energy charge management system to optimally control the supply-demand balance between energy production and consumption by using aggregation technology developed during Virtual Power Plant test projects over the past several years. This system will also incorporate the Kyocera's renewable energy generating system. Meanwhile, BYD will supply two models of electric buses; K9, a large electric bus already available to the global market and J6, a compact electric bus specifically developed for the Japanese market which will be available in spring 2020. Additionally, BYD will use its technological expertise in developing electric buses and insights from energy consumers to consult on the project."
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NTIC | Hot Stocks08:09 EDT Northern Technologies announces two-for-one stock split - Northern Technologies reported that its board has declared a two-for-one split of the company's common stock, which will be effected in the form of a 100% stock dividend. The stock dividend will be distributed on June 28 to stockholders of record as of June 17. As a result of the split, each stockholder of record at the close of business on June 17 will receive one additional share of common stock for every outstanding share held on the record date. The additional shares will be distributed on June 28.
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XNCR | Hot Stocks08:08 EDT Xencor doses first patient in Phase 1 study of XmAb22841 - Xencor announced that the first patient has been dosed in a Phase 1 clinical study to evaluate the safety and tolerability of XmAb22841, both as a monotherapy and in combination with pembrolizumab, in patients with advanced solid tumors. XmAb22841 is a bispecific antibody that simultaneously targets the immune checkpoint receptors CTLA-4 and LAG-3. The Phase 1 dose-escalation and expansion study, which explores XmAb22841 as a monotherapy and in combination with pembrolizumab will characterize the safety and tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity of intravenous administration in patients with select advanced solid tumors.
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MNKD | Hot Stocks08:07 EDT MannKind says Afrezza inhalation powder approved in Brazil - MannKind Corporation announced that Afrezza Inhalation Powder, an ultra rapid-acting mealtime insulin to improve glycemic control in adult patients with diabetes mellitus, has been registered by the Brazilian Health Regulatory Agency. The commercialization of Afrezza in Brazil is expected to begin in the fourth quarter this year, subject to the pricing registration process by Camara de Regulacao do Mercado de Medicamentos. "The regulatory approval of Afrezza in Brazil is an important milestone for MannKind and our partner Biomm. It not only represents our first international approval of Afrezza, but more importantly, we now have the opportunity to bring a novel mealtime insulin therapy to patients in a country with one of the highest prevalence of diabetes in the world, according to the International Diabetes Federation," said Michael Castagna, CEO.
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SGEN | Hot Stocks08:07 EDT Seattle Genetics announces additional analyses of ECHELON-1, ECHELON-2 trials - Seattle Genetics announced additional analyses of results from ECHELON-1 and ECHELON-2, the frontline phase 3 trials of ADCETRIS, at the 2019 American Society of Clinical Oncology Annual Meeting. The ECHELON-1 analysis highlights a three-year update of this phase 3 clinical trial evaluating ADCETRIS in combination with AVD compared to ABVD in stage III or IV frontline classical Hodgkin lymphoma patients, including analyses by cycle 2 PET status and in patients less than 60 years old. In addition, two poster presentations evaluate CD30 expression and response to ADCETRIS treatment in the ECHELON-2 phase 3 clinical trial in peripheral T-cell lymphomas and an analysis of five additional trials in T-cell and B-cell non-Hodgkin lymphomas. ADCETRIS is an antibody-drug conjugate directed to CD30, a defining marker of classical HL and expressed on the surface of several types of PTCL. Brentuximab Vedotin with Chemotherapy for Stage 3/4 Classical Hodgkin Lymphoma: 3-year Update of the ECHELON-1 Study: This poster presentation examines progression-free survival outcomes per investigator assessment in the intent-to-treat population of 1,334 patients at three-years by PET status and in patients less than 60 years old. As previously reported, the ECHELON-1 trial achieved its primary endpoint with the combination of ADCETRIS plus AVD resulting in a statistically significant improvement in modified PFS versus the control arm of ABVD as assessed by independent review facility. Modified PFS was defined as time to progression, death, or evidence of non-complete response after completion of frontline therapy per IRF followed by subsequent anticancer therapy. Key findings from these analyses include: The three-year PFS for all patients in the ADCETRIS plus AVD arm was 83.1 percent compared to 76 percent in the ABVD arm, a difference of 7.1 percent. PFS benefit at three-years for ADCETRIS plus AVD was observed for all patients independent of PET2 status, including in patients who are less than 60 years old. PET2-negative result was 85.8 percent in the ADCETRIS plus AVD arm compared to 79.5 percent in the ABVD arm, a difference of 6.3 percent. PET2-positive result was 67.7 percent in the ADCETRIS plus AVD arm compared to 51.5 percent in the ABVD arm, a difference of 16.2 percent. Consistent improvement in PFS was observed among patients treated with ADCETRIS plus AVD compared with ABVD across the majority of pre-specified subgroups, including disease stage, age and prognostic score. As previously reported at the primary analysis, on the ADCETRIS plus AVD arm, peripheral neuropathy events were observed in 67 percent of patients compared to 43 percent in the ABVD arm. The three-year analysis shows that among patients with peripheral neuropathy, 78 percent of in the ADCETRIS plus AVD arm and 83 percent in the ABVD arm reported complete resolution or improvement at last follow-up. Response to A+CHP by CD30 Expression in the ECHELON-2 Trial: As previously reported, the ECHELON-2 trial met its primary endpoint with the combination of ADCETRIS plus CHP resulting in a statistically significant improvement in PFS versus the control arm of CHOP per Blinded Independent Central Review. In addition, overall survival in the ADCETRIS plus CHP arm was statistically significant compared to CHOP. Complete remission rate and objective response rate for the ADCETRIS plus CHP arm were also significantly increased. CD30 expression is a hallmark of systemic anaplastic large cell lymphoma, but it is variably expressed among non-sALCL PTCL subtypes. As a lack of correlation between CD30 expression and response to ADCETRIS has been previously reported, an analysis was conducted to examine response to ADCETRIS plus CHP by CD30 expression in 57 patients with angioimmunoblastic T-cell lymphoma and PTCL-not otherwise specified in the ECHELON-2 study, the two histologies with variable expression. Key findings of this exploratory analysis include: Among AITL and PTCL-NOS patients, the ORR in patients treated with ADCETRIS plus CHP was independent of the level of CD30 expression. CRs and PRs were observed in patients with all levels of CD30 expression, including those with the lowest level of 10 percent. The duration of complete response was not associated with CD30 expression level for patients with AITL or PTCL-NOS. Response to Brentuximab Vedotin by CD30 Expression: Results from Five Trials in PTCL, CTCL, and B-cell Lymphomas: Exploratory analyses were conducted to examine the correlation between pretreatment CD30 expression level and ORR for patients with CD30 expression greater than or equal to 10 percent, less than 10 percent, or undetectable by immunohistochemistry. This analysis examined CD30 expression levels of 275 patients across five clinical studies in relapsed or refractory PTCL, cutaneous T-cell lymphoma, and B-cell NHL. All patients in this analysis were treated with ADCETRIS monotherapy. The key findings include: Responses were observed with ADCETRIS treatment in patients with all levels of CD30 expression, including in patients with no detectable CD30 expression by IHC. Response to ADCETRIS was not associated with CD30 expression level. The U.S. Food and Drug Administration approved ADCETRIS in combination with AVD for the treatment of adult patients with previously untreated stage III or IV classical HL in March 2018, based on the results of the ECHELON-1 phase 3 clinical trial. The FDA approved ADCETRIS in combination with CHP for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including AITL and PTCL-NOS based on the results of the ECHELON-2 phase 3 trial, in November 2018.
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VBLT | Hot Stocks08:07 EDT VBL Therapeutics presents VB-111 data at ASCO - VBL Therapeutics announced that MRI data from VB-111 Phase 2 and Phase 3 studies in recurrent GBM, or rGBM, presented at the American Society of Clinical Oncology, or ASCO annual meeting, showed a survival benefit associated with objective responses to the compound and a distinct signature of VB-111 activity. The UCLA analysis compared data from VBL's Phase 2 study of VB-111, which met the primary endpoint of OS benefit with a median OS, or mOS, of 414 days, to MRI data from the treatment arm in the GLOBE Phase 3 study, which had a mOS of 6.8 months, despite similar baseline tumor volume between patient cohorts. The goal of the analysis was to investigate the difference between the trial outcomes, using quantitative radiographic tools. There was a notable difference in the regimens between the studies: in the Phase 2 study, VB-111 was administered first as a single agent therapy with bevacizumab added to VB-111 upon further progression; in contrast, the GLOBE Phase 3 study regimen included co-administration of VB-111 and bevacizumab from the start of study therapy without any VB-111 monotherapy priming period.
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AOS | Hot Stocks08:07 EDT A.O. Smith raises 2019 share repurchase program by 50% to $300M - On June 2, the Board of Directors of A. O. Smith approved adding 3M shares of common stock to an existing discretionary share repurchase authority. Including the additional shares, the company has 7,550,753 shares remaining on the board share repurchase authority. The company increased the amount of its 2019 planned Rule 10b5-1 automatic trading plan and opportunistic share repurchase program from its previously stated $200M to $300M, depending on factors such as stock price, working capital requirements and alternative investment opportunities.
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BTAI... | Hot Stocks08:07 EDT BioXcel Therapeutics announces FDA clearance of IND for BXCL701 therapy - BioXcel Therapeutics (BTAI) announced an update of its immuno-oncology program for BXCL701, an orally-available systemic innate-immune activator with dual mechanisms of action. BTI is a clinical-stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology. BTI reported that its Investigational New Drug application has received clearance from the U.S. Food and Drug Administration to start a clinical trial to evaluate the triple combination of BXCL701, bempegaldesleukin and avelumab for the treatment of pancreatic cancer as a second line therapy. BTI is collaborating with Nektar Therapeutics (NKTR), Merck KGaA (MKGAY) and Pfizer (PFE) to conduct this trial. Louis M. Weiner, M.D., Director of Georgetown Lombardi Comprehensive Cancer Center, a National Cancer Institute-designated comprehensive cancer center, will serve as the Principal Investigator. In addition, BTI announcedthe acceptance of the company's clinical trial authorization by the UK's MHRA of a trial evaluating the combination of BXCL701 and pembrolizumab in tNEPC. Under the supervision of the European Principal Investigator, Professor Johann de Bono, M.D., Ph.D. of The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, BTI plans to open its Phase 1b/2 study of BXCL701 and Keytruda in tNEPC, a hormone-refractory form of prostate cancer, in the UK. BTI currently believes that no viable treatment option exists for this type of cancer. The Company has opened multiple sites in the US, and data from the open-label trial is expected to support the ongoing global clinical development of BXCL701.
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PTCT | Hot Stocks08:05 EDT PTC Therapeutics names Emily Hill as CFO - PTC Therapeutics announced the promotion of Emily Hill to CFO. Hill joined PTC Therapeutics in November 2013 and was most recently Senior Vice President and Head of Investor Relations. Prior to joining PTC Therapeutics, Emily was Director of Investor Relations of Warner Chilcott.
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AINC... | Hot Stocks08:03 EDT Ashford to acquire Remington's Hotel Management business for $275M - Ashford announced that it has signed a definitive agreement to acquire the Hotel Management business of privately-held Remington Holdings. The transaction, which is expected to close sometime in the fourth quarter, is subject to approval by the company's stockholders, the receipt of an acceptable Private Letter Ruling from the Internal Revenue Service, and customary closing conditions. Under the terms of the agreement, Ashford will acquire Remington's Hotel Management business for a purchase price of $275M, payable by the issuance of $275M of a new Series D Convertible Preferred Stock. The company's Board of Directors formed a special committee of independent and disinterested directors to analyze, negotiate, and recommend the transaction to Ashford's Independent Directors. Ashford's Independent Directors have unanimously recommended approval of the acquisition by Ashford's stockholders.
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DAVA | Hot Stocks07:59 EDT Endava announces 2 corporate transactions - Endava: "As previously disclosed, Worldpay has an option to purchase Endava Technology SRL, also referred to as 'the Captive,' from us. The Captive is located in Bucharest, Romania and its 138 current employees work exclusively for Worldpay. Worldpay requested, and Endava agreed to allow, an early exercise of the option, which was not exercisable until September 2019. The aggregate purchase price for the Captive is within the previously agreed range as disclosed in Endava's filings with the SEC. The transaction is expected to close during the first quarter of Endava's 2020 fiscal year, subject to Romanian regulatory approval. Upon closing, the employees of the Captive will become employees of Worldpay. In connection with the transaction, Endava has agreed to provide Worldpay certain transition services under the existing Master Services Agreement, or MSA, between Endava and Worldpay, which will remain in place following the closing of the sale of the Captive. This strong relationship is being further strengthened through an extension of volume commitment timelines under the MSA and a potential opportunity to expand our collaboration into the U.S., which remains subject to entry into a binding agreement. Currently 291 Endavans are deployed on Worldpay projects contracted for under the MSA, which is in addition to and separate from the work done by the Captive and its employees for Worldpay. This transaction does not impact Endava's FY19 guidance and we plan to provide FY20 guidance on our next earnings call. Further, in recognition of growing demand for cloud-based CRM expertise as a facilitator for digital transformation, including requirements identified in many of Endava's clients, we are delighted to announce that a 32 person strong team of highly experienced cloud software implementation specialists based in Romania joined Endava on June 1, bringing with them a profitable revenue stream. Endava intends to build on this core to rapidly grow its cloud software implementation capability."
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VRNT | Hot Stocks07:54 EDT Verint urges stockholders to vote for all of company's directors - Verint Systems announced that it has sent a letter to stockholders in connection with its upcoming Annual Meeting of Stockholders. The letter read, in part, "Over two years ago, Verint's Board began a strategic transformation that is delivering significant value to our stockholders. This successful strategy, which includes accelerated innovation, evolving financial disclosures and Board refreshment - is under serious threat - and so is the value of your investment...Neuberger Berman, a 2.6% stockholder who has already had input into the selection of one of our eight directors, is attempting to gain additional Board influence so that it can force significant and abrupt changes on Verint that we believe would destroy value. Our Board has embraced change and is committed to further change to continue to drive stockholder value, but believes that Neuberger Berman's ideas, if adopted, would harm our customer relationships, disrupt our business momentum, and remove Board members who are vital to the success of our company...We are determined to protect our stockholders from Neuberger Berman's ill-informed and dangerous ideas. We believe their proposed actions - some of which they have not fully disclosed in public - would damage the value of your investment. We have engaged extensively and have tried to reason with Neuberger Berman, but - despite their public claims - they are privately insisting on increasing their influence on our Board, we believe, to further their value-destructive agenda...We believe Neuberger Berman is trying to mislead you by asking for changes that they know have already been underway for two years, at the Board's initiation...We are committed to ongoing Board refreshment, and we have added three new directors over the last three years, including one director at Neuberger Berman's suggestion in 2017. This fiscal year we intend to continue the refreshment process and add a director with recent and relevant experience in cloud, cyber security, and/or software who will also enhance the diversity of the Board...We strongly urge stockholders to support Verint by voting "FOR" Verint's entire slate of eight highly qualified directors on the WHITE proxy card."
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LVS... | Hot Stocks07:52 EDT Macau reports May casino revenue up 1.8% to 25.95B patacas - Macau's gaming bureau reported May gross revenue from games of fortune in the region increased 1.8% year-over-year to 25.95B patacas. Publicly traded companies in the Macau gaming space include Las Vegas Sands (LVS), MGM Resorts (MGM), Wynn Resorts (WYNN) and Melco Resorts (MLCO).
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SNV RF | Hot Stocks07:49 EDT Synovus appoints Jamie Gregory as EVP, CFO - Synovus (SNV) announced the appointment of Jamie Gregory as EVP and CFO, effective June 24. He currently serves as EVP and head of corporate financial strategy for Regions Financial Corporation (RF). Gregory succeeds Kevin Blair, who has served as acting CFO since December 2018, when he was appointed COO of Synovus.
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SGEN ALPMY | Hot Stocks07:43 EDT Seattle Genetics, Astellas announce data from cohort of EV-201 trial - Seattle Genetics (SGEN) and Astellas Pharma (ALPMY) announced that data from the first cohort of a pivotal phase 2 clinical trial known as EV-201 demonstrated that the investigational agent enfortumab vedotin rapidly shrank tumors in most patients, resulting in an objective response rate of 44 percent. Complete responses were observed in 12 percent of patients. The median duration of tumor response was 7.6 months. This cohort was open to patients with locally advanced or metastatic urothelial cancer who had received previous treatment with a platinum-containing chemotherapy and a PD-1/L1 checkpoint inhibitor. Responses were similar in the subgroups of patients analyzed, including those who had the worst prognosis, such as patients who had three or more previous lines of therapy, patients with liver metastases, and those who had not responded to a PD-1/L1 inhibitor. Treatment-related adverse events that occurred in 40 percent or more of patients were fatigue, alopecia, rash, decreased appetite, taste distortion, and peripheral neuropathy. Enfortumab vedotin is an investigational antibody-drug conjugate that targets Nectin-4, a protein that is highly expressed in urothelial cancers. Based on the results of the EV-201 trial, the companies plan to submit a Biologics License Application for enfortumab vedotin to the U.S. Food and Drug Administration this year. Based on preliminary results from the phase 1 EV-101 trial, the FDA granted enfortumab vedotin Breakthrough Therapy designation for people with locally advanced or metastatic urothelial cancer whose disease has progressed during or following checkpoint inhibitor therapy. A global, randomized phase 3 confirmatory clinical trial is ongoing and is intended to support global registrations. Another trial is underway to evaluate enfortumab vedotin in earlier lines of treatment for patients with locally advanced or metastatic urothelial cancer, including in combination with pembrolizumab and/or platinum chemotherapy in newly diagnosed patients as well as patients who progressed from earlier-stage disease. In the first cohort of the EV-201 study, 125 patients were treated with enfortumab vedotin. The primary endpoint of confirmed objective response rate was 44 percent per blinded independent central review. The overall duration of response, a key secondary endpoint, was 7.6 months. Most responses occurred within the first cycle of treatment, and were observed across all pre-specified patient subgroups irrespective of lines of therapy, response to prior PD-1/L1 inhibitor, or presence of liver metastases: Three or more prior therapies: 41 percent ORR; Non-responders to PD-1/L1 inhibitors: 41 percent ORR; Liver metastases: 38 percent ORR; Median overall survival was 11.7 months, and the median progression-free survival was 5.8 months. The most common treatment-related adverse events occurring in more than 40 percent of patients were fatigue; alopecia; rash; decreased appetite; taste distortion; and peripheral neuropathy. Most peripheral neuropathy and rash were less than or equal to Grade 2 in severity. Hyperglycemia occurred in 11 percent of patients. The most common severe AEs were: neutropenia - experienced by 8 percent of patients; anemia in 7 percent of patients; and fatigue in 6 percent of patients. One death due to interstitial lung disease occurred outside the safety-reporting period and was confounded by prolonged high-dose steroid use and suspected pneumonia.
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AEHR | Hot Stocks07:40 EDT Aehr Test Systems announces shipments of FOX-CP, FOX-NP in Q4 - Aehr Test Systems announced that it began shipments of its recently introduced FOX-CP and FOX-NP test and burn-in systems in its Q4, which closed on May 31. These shipments, which included multiple FOX-NP systems, were for orders previously announced earlier this year. The new FOX-CP and FOX-NP systems, which were introduced in the last few months, are the newest additions to Aehr's FOX-PTM family of semiconductor wafer level and singulated die test and burn in systems.
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ALPN | Hot Stocks07:39 EDT Alpine Immune Sciences appoints Wayne Gombotz as Chief Technology Officer - Alpine Immune Sciences (ALPN) announced the appointment of Wayne Gombotz, PhD as Chief Technology Officer. Dr. Gombotz has more than 30 years' experience in the biotech and pharma industries and most recently served as the Chief Development Officer at Immune Design.
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STIM | Hot Stocks07:38 EDT Neuronetics receives national reimbursement listing in Japan for NeuroStar - Neuronetics announced that Japan's Ministry of Health, Labour and Welfare, or MHLW, listed reimbursement for the company's NeuroStar Advanced Therapy System for the treatment of Major Depressive Disorder, or MDD, in adults. MHLW and Japan's Central Social Insurance Medical Council approved reimbursement earlier this year and the listing is effective as of June 1. Reimbursement of NeuroStar Advanced Therapy, listed under Japan's national health insurance, addresses an need for patient access to care. As many as 2.5M people are living with depression in Japan, according to the MHLW.
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EE JPM | Hot Stocks07:37 EDT EPE to be acquired by Infrastructure Investments Fund for $68.25/share - El Paso Electric, or EPE, (EE) and the Infrastructure Investments Fund, an investment vehicle advised by J.P. Morgan Investment Management, or IIF, (JPM) announced that they have entered into a definitive agreement under which IIF will purchase EPE for $68.25 in cash per share representing an enterprise value of approximately $4.3B. IIF will purchase EPE for $68.25 per share in cash representing an enterprise value of approximately $4.3 billion, including EPE's net debt. The per share purchase price represents a 17% premium to EPE's closing price on May 31, 2019, the last trading day prior to the announcement of the agreement. The agreement has been unanimously approved by EPE's Board of Directors and is expected to close in the first half of 2020, subject to the approval of EPE's shareholders, the receipt of regulatory approvals and other customary closing conditions. Dividends payable to EPE shareholders will continue in the ordinary course through the closing.
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SIGA PFE | Hot Stocks07:36 EDT Siga Technologies enters promotion agreement with Meridian for TPOXX - Siga Technologies (SIGA) announced that it has entered into an international promotion agreement with Meridian, a Pfizer (PFE) company. Under the agreement, Meridian will promote the sale of oral TPOXX for the treatment of smallpox in all markets, except for the United States and South Korea. Siga will continue to be the owner of all rights in the U.S. market. Under the terms of the agreement, Meridian has exclusive rights and responsibilities to market and sell oral TPOXX in all geographic regions except for the U.S. and South Korea, and SIGA retains ownership, distribution and supply rights and regulatory responsibilities in connection with TPOXX. The agreement does not include any cash payments at signing, and both parties are responsible for the costs of their respective activities. Meridian will be compensated under the promotion agreement through a fee that will be based on a percentage of net sales of oral TPOXX.
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XON | Hot Stocks07:34 EDT Intrexon to advance GreenVenus Romaine lettuce to commercial trials - Intrexon announced it is advancing GreenVenus Romaine lettuce to commercial trials. Initial data under commercial indoor production conditions indicate that GreenVenus has improved shelf-life up to 2 weeks and a potential for higher marketable yield with no tip burn. In addition, GreenVenus non-browning lettuce has been assessed by the United States Department of Agriculture and determined not to be subject to regulation under 7CFR Part 340 for plants altered or produced through genetic engineering.
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EE | Hot Stocks07:34 EDT EPE to be acquired by Infrastructure Investments Fund for $68.25/share
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ZLAB | Hot Stocks07:33 EDT Zai Lab appoints Valeria Fantin as CSO - Zai Lab announced the appointment of Valeria Fantin as CSO. Fantin will lead the company's internal drug discovery effort on a global basis and will be based in the company's U.S. headquarters in San Francisco, reporting to Samantha Du. Fantin joins Zai Lab from ORIC Pharmaceuticals, where she served as CSO.
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CBAN | Hot Stocks07:33 EDT Colony Bankcorp names Lance Whitley chief people officer - Colony Bankcorp announced that Lawrence A. "Lance" Whitley will join the Bank on June 10, 2019, as its Chief People Officer. In this position, Whitley will manage the strategy and processes related to identifying talented new team members, strengthening the Company's existing organization, and helping it retain the outstanding group of banking professionals needed to drive Colony's future growth. He replaces Julia Shadwick, who is no longer with the Bank. Whitley will report to Kimberly Dockery, Chief Administrative Officer.
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SGEN ALPMY | Hot Stocks07:33 EDT Seattle Genetics, Astellas Pharma: Enfortumab vedotin rapidly shrank tumors - Astellas Pharma (ALPMY) and Seattle Genetics (SGEN) announced that data from the first cohort of a pivotal phase 2 clinical trial known as EV-201 demonstrated that the investigational agent enfortumab vedotin rapidly shrank tumors in most patients, resulting in an objective response rate of 44% (55/125). Complete responses were observed in 12% of patients (15/125). The median duration of tumor response was 7.6 months (range 0.95-11.3+). This cohort was open to patients with locally advanced or metastatic urothelial cancer who had received previous treatment with a platinum-containing chemotherapy and a PD-1/L1 checkpoint inhibitor. Responses were similar in the subgroups of patients analyzed, including those who had the worst prognosis, such as patients who had three or more previous lines of therapy, patients with liver metastases, and those who had not responded to a PD-1/L1 inhibitor. Treatment-related adverse events that occurred in 40% or more of patients were fatigue, alopecia, rash, decreased appetite, taste distortion, and peripheral neuropathy.
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URI | Hot Stocks07:32 EDT United Rentals announces enhanced capital allocation strategy - United Rentals announced that its board of directors has approved an enhanced capital allocation strategy that remains focused on balancing growth and returns. Specifically, the company is lowering its targeted leverage range to 2.0x-3.0x, from 2.5x-3.5x. The company expects to end the year with a net leverage ratio of approximately 2.5x versus a reported net leverage ratio of 2.9x as of March 31, 2019. CEO Matthew Flannery said, "Over the last decade our capital allocation strategy has served our company and our investors well. This change is consistent with other actions we've taken to deploy our capital with a balanced approach to grow our business, enhance our cash flows and improve financial flexibility. The evolution of our business, and the resulting durable cash flow, provides us the further opportunity to both fully support our growth initiatives and reduce our financial leverage."
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TAK | Hot Stocks07:32 EDT Takeda announces new data from ad-hoc analysis of Phase 3 HELP Study - Takeda Pharmaceutical announced new data from an ad-hoc analysis of the Phase 3 HELP Study, designed to evaluate the onset of action for TAKHZYRO during days 0-69 of treatment. The analysis suggests that TAKHZYRO starts to prevent hereditary angioedema, or HAE, attacks during this early treatment phase, with patients experiencing an 80.1% decrease in mean monthly attack rate compared to placebo. The results were presented during the European Academy of Allergy and Clinical Immunology, or EAACI, Congress in Lisbon, Portugal. HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of oedema in various parts of the body. The ad-hoc analysis evaluated the efficacy of TAKHZYRO compared with placebo during days 0-69 of treatment using the same approach that was used to evaluate the primary and secondary endpoints during the complete study period. Results from the analysis showed that in patients receiving the recommended starting dose of TAKHZYRO 300 mg every two weeks, there was a significant reduction in mean monthly attack rate compared to placebo. During this initial treatment phase, patients treated with TAKHZYRO 300 mg every two weeks also experienced fewer severe attacks compared to placebo and were more likely to be HAE attack-free compared to those on placebo.
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EMITF | Hot Stocks07:30 EDT Elbit Imaging announces Insightec receives national reimbursement from MHLW - Elbit Imaging announced that Insightec has received national reimbursement from the Japanese Ministry of Health, Labour and Welfare, or MHLW, for treating essential tremor. The Exablate Neuro device received MHLW approval to treat medication-refractory essential tremor in December 2016. There are currently nine Exablate Neuro systems in Japan performing the MR-guided focused ultrasound treatment for essential tremor on a routine basis. The company holds approximately 62% of the share capital of Elbit Medical which, in turn, holds approximately 22% of the share capital in Insightec.
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NSANY... | Hot Stocks07:30 EDT Nissan CEO says would review Renault relationship after FCA merger - Nissan (NSANY) CEO Hiroto Saikawa said in a statement: "I am aware that FCA's (FCAU) merger proposal will be discussed by Renault's (RNSDF) board this week. I believe that the potential addition of FCA as a new member of the Alliance could expand the playing field for collaboration and create new opportunities for further synergies. That said, the proposal currently being discussed is a full merger which-if realized-would significantly alter the structure of our partner Renault. This would require a fundamental review of the existing relationship between Nissan and Renault. From the standpoint of protecting Nissan's interests, Nissan will analyze and consider its existing contractual relationships and how we should operate business in the future."
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ATXI | Hot Stocks07:30 EDT Avenue Therapeutics trading resumes
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T | Hot Stocks07:23 EDT AT&T little changed after Trump suggests people stop using service - Shares of AT&T are down 10c to $30.48 in pre-market trading after President Trump tweeted, "I believe that if people stoped using or subscribing to @ATT, they would be forced to make big changes at @CNN, which is dying in the ratings anyway. It is so unfair with such bad, Fake News! Why wouldn't they act. When the World watches @CNN, it gets a false picture of USA. Sad!"
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MYGN | Hot Stocks07:21 EDT Myriad Genetics announces results from myRisk studies to be featured at ASCO - Myriad Genetics announced that results from two studies of the myRisk Hereditary Cancer test will be featured in presentations at the annual meeting of the American Society of Clinical Oncology, or ASCO. The key findings were that women with post-menopausal breast cancer had a high rate of inherited mutations in a range of cancer causing genes, and that overall this mutation rate did not diminish with age. In a separate study, panel testing did not appear to result in over-use of preventative surgery. The findings will be presented by research collaborators from Stanford University Cancer Institute and the University of Southern California Norris Comprehensive Cancer Center.
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SPX SPY | Hot Stocks07:21 EDT Trump announces departure of White House economic adviser Kevin Hassett - President Donald Trump said via Twitter: "Kevin Hassett, who has done such a great job for me and the Administration, will be leaving shortly. His very talented replacement will be named as soon as I get back to the U.S. I want to thank Kevin for all he has done - he is a true friend!" Reference Link
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T | Hot Stocks07:20 EDT Trump tweet's AT&T's CNN is 'very bad for U.S.' - President Donald Trump tweeted: "The only problem is that @CNN is the primary source of news available from the U.S. After watching it for a short while, I turned it off. All negative & so much Fake News, very bad for U.S. Big ratings drop. Why doesn't owner @ATT do something? I believe that if people stoped using or subscribing to @ATT, they would be forced to make big changes at @CNN, which is dying in the ratings anyway. It is so unfair with such bad, Fake News! Why wouldn't they act. When the World watches @CNN, it gets a false picture of USA. Sad!"
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MSON | Hot Stocks07:20 EDT Misonix receives 510 clearance for Nexus from FDA - Misonix announced that it received 510 clearance by the FDA for Nexus, its ultrasonic surgical platform. Misonix will commence the commercialization of the Nexus platform in the United States in July. Nexus is an integrated ultrasonic surgical platform that combines all the features of Misonix's existing solutions, including BoneScalpel, SonicOne and Sonastar, into a single fully integrated platform that will also serve to power future solutions. The Nexus platform is driven by a new proprietary digital algorithm.
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GNCA | Hot Stocks07:17 EDT Genocea presents GEN-009 data at ASCO - Genocea announced clinical results from its ongoing Phase 1/2a trial for GEN-009, the company's neoantigen vaccine candidate. The results were presented in a poster over the weekend at this year's American Society of Clinical Oncology, or ASCO. In the five patients for whom immune response results are available to date, GEN-009 monotherapy elicited T cell responses to 91% of the vaccine neoantigens administered. GEN-009 has proven to be unique among neoantigen vaccines in its ability to elicit ex vivo CD8+ T cell responses, which were observed for 47% of vaccine neoantigens. Inclusive of the results seen after in vitro stimulation, the CD8+ T cell response frequency was 53%. GEN-009 has been well tolerated to date, with no dose-limiting toxicities.
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ATXI | Hot Stocks07:15 EDT Avenue Therapeutics Phase 3 tramadol study achieves primary, secondary endpoints - Avenue Therapeutics announced that its second pivotal Phase 3 trial of IV tramadol achieved the primary endpoint of a statistically significant improvement in sum of pain intensity difference over 24 hours, or SPID24, compared to placebo in patients with postoperative pain following abdominoplasty surgery. In addition, the trial met all of its key secondary endpoints. The study also includes a standard-of-care IV opioid as an active comparator: IV morphine 4 mg. In this study, IV tramadol also demonstrated similar efficacy and safety to that of IV morphine. The Phase 3 multicenter, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of IV tramadol in 370 patients following abdominoplasty surgery. Patients were randomized in a 3:3:2 ratio to a postoperative regimen of 50 mg of IV tramadol, placebo, or 4 mg of IV morphine at hours 0, 2, 4 and once every 4 hours thereafter, respectively, for up to 13 doses over the course of 48 hours. Morphine, a standard-of-care analgesic, was included to obtain comparative safety data versus IV Tramadol. The primary efficacy endpoint of the study assessed the analgesic efficacy of IV tramadol compared to placebo as measured by SPID24. The key secondary efficacy endpoints included Patient Global Assessment at 24 hours, SPID48, and total consumption of rescue medicine through 24 hours. A key safety objective of the study was to compare the safety and tolerability of IV tramadol to IV morphine. IV tramadol 50 mg achieved the primary endpoint of statistically superior improvement in pain relief as measured by the SPID24 compared to placebo, as well as met all three key secondary endpoints. IV tramadol and IV morphine demonstrated similar efficacy benefits in the study. IV tramadol was well-tolerated with no drug-related serious adverse events in the trial. Most adverse events were mild or moderate with only 2 patients experiencing a Grade 3 event.
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AVDL | Hot Stocks07:10 EDT Avadel Pharmaceuticals announces Gregory Divis as CEO - Avadel Pharmaceuticals announced the appointment of Gregory Divis as CEO and member of the board. Divis has served as interim CEO since January. Divis joined Avadel as chief commercial officer in January 2017. He was promoted to COO in March 2018 and named interim CEO in January. Prior to joining Avadel, he served as an executive in residence at Linden Capital Partners, a healthcare-focused private equity firm.
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REXR | Hot Stocks07:09 EDT Rexford Industrial acquires two industrial properties for $34.5M - Rexford Industrial Realty announced the acquisition of two industrial properties for a total of $34.5M. The acquisitions were funded using cash on hand. The company acquired 218 S. Turnbull Canyon Road, located in the City of Industry within the LA - San Gabriel Valley submarket, for $27.1M, or $142 per square foot. The company also acquired 9750 San Fernando Road, located in Sun Valley within the LA - Greater San Fernando Valley submarket, for $7.4M, or $63 per land square foot.
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CANF | Hot Stocks07:09 EDT Can-Fite says Phase II liver cancer study did not meet primary endpoint - Can-Fite BioPharma announced that data from its recently completed Phase II trial in patients with hepatocellular cancer, the most common form of liver cancer, was presented at the late-breaking abstract session of the 54th Annual Meeting of the American Society of Clinical Oncology. Prof. Salomon M. Stemmer, Principal Investigator of Can-Fite's Phase II trial, delivered the presentation on Sunday June 2, 2019 at the Developmental Immunotherapy and Tumor Immunobiology session. The presentation is entitled: "A phase II, randomized, double-blind, placebo-controlled trial evaluating efficacy and safety of namodenoson, an a3 adenosine receptor agonist, as a second-line treatment in patients with Child-Pugh B advanced hepatocellular carcinoma." While the Phase II study did not achieve its primary endpoint of overall survival in the whole population, superiority in overall survival was found in the largest study subpopulation of patients who were classified Child Pugh B7, based on severity of disease compared to the placebo treated group. Median survival in the Namodenoson group was 6.8 months, versus 4.3 months for the placebo group. The "most impressive" finding was that 44% of the patients with Child Pugh B7 treated with Namodenoson were alive at one year compared to 18% in the placebo group. In the overall patient population, among patients who had at least one assessment post baseline, disease control was significant in the Namodenoson group, 26% versus 10% in the control group after four months of treatment, P value 0.013. Among the other positive findings that were presented is the 9% partial response in the Namodenoson treated group vs. 0% in the placebo group. An example of a patient demonstrating an excellent tumor shrinkage was presented. A3AR expression level at baseline was 1.98+/-0.36 in comparison to 1 unit in healthy subjects and was not changed substantially during the treatment period, demonstrating that continuous treatment with Namodenoson does not result in de-sensitization or loss of the target. Consistent with its previously demonstrated favorable safety profile, Namodenoson showed an adverse event profile that was comparable to that of placebo.
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MUR | Hot Stocks07:08 EDT Murphy Oil announce close of Gulf acquisition, provides updated production view - Murphy Oil announced that its wholly owned subsidiary, Murphy Exploration & Production Company - USA, has closed the previously announced strategic deep water Gulf of Mexico acquisition from LLOG Exploration Offshore, L.L.C. and LLOG Bluewater Holdings, or LLOG. The transaction was previously announced on April 23, with an effective date of January 1. After taking into account customary closing adjustments, Murphy's total cash consideration paid was $1.23 billion, which was funded primarily through the company's $1.6 billion revolver and other sources of liquidity. The acquired assets will be fully owned by Murphy Exploration & Production Company - USA and not part of MP Gulf of Mexico, or MP GOM, the entity which currently owns all of Murphy's legacy producing Gulf of Mexico assets. During the month of June, after accounting for a planned curtailment from a third-party downstream pipeline outage, the average net production for the acquired assets is expected to be approximately 22,000 to 24,000 Boepd. Following the temporary downstream pipeline outage, Murphy anticipates production for the acquired assets for the second half of the year to be 31,000 to 33,000 Boepd, which is in line with previously disclosed annualized production of 32,000 to 35,000 Boepd.
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NNVC | Hot Stocks07:08 EDT NanoViricides receives favorable FDA comments on lead drug candidate - NanoViricides that it has received favorable comments from the U.S. FDA on the company's pre-IND application for its lead drug candidate. The company reports that the U.S. FDA has generally agreed in its pre-IND response that the plan of drug development presented by the company to the FDA is generally adequate at this time. The company received the response on May 23. In particular, the Agency has agreed that the company's strategy for drug substance and drug product acceptance criteria is adequate. The Agency has further agreed that the IND-enabling non-clinical studies proposed by the company are generally adequate. The U.S. FDA also said that the proposed design of the IND-opening human clinical studies appears reasonable at this time.
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TC | Hot Stocks07:07 EDT TuanChe to acquire Longye for U.S. equivalent of RMB200M - TuanChe announced that it entered into a share purchase agreement with, among other parties, Longye, a company incorporated in the Cayman Islands. Pursuant to the agreement, the company has agreed to acquire the entire equity interest in Longye for a U.S.-dollar equivalent of RMB200M in the form of cash and the company's securities in aggregate. According to the agreement and subject to customary closing conditions, the company agreed to extend a bridge loan of a U.S.-dollar equivalent of RMB100M upon the execution of the agreement and other related documents, credit this bridge loan to the cash portion of the purchase price and issue 8,366,444 Class A ordinary shares of the company to the selling shareholders of Longye. The consideration shares are calculated by dividing a US-dollar equivalent of RMB100M by the average closing price of the company's shares during the thirty-day period ended on May 10. The consideration shares will be subject to contractual restrictions on transfer. Additionally, 20%, 30%, and 50% of consideration shares will have contractual restrictions lifted on January 1, 2020; January 1, 2021 and January 1, 2022, respectively. The acquisition of Longye is subject to the relevant corporate approvals, customary closing conditions, and pre-acquisition corporate restructuring. There is no assurance that any such procedures or transactions will be completed in a timely manner, or at all. Longye has been a system developer that develops and implements social customer relationship management cloud systems for China's automotive industry since June 2013.
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GRP | Hot Stocks07:06 EDT Granite Real Estate announces departure of CFO - Granite Real Estate announced that Ilias Konstantopoulos, Granite's CFO, has left Granite to pursue other opportunities. The appointment of a new CFO will be announced in due course.
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MICT | Hot Stocks07:05 EDT Micronet Ltd. announces new orders of $1M - MICT announced that on June 2, Micronet Ltd. announced that on May 31, it received two purchase orders totaling $1M for the supply and delivery of its TREQ VMX platform. Micronet Ltd., an entity in which MICT has a voting stake of approximately 39.53%, received the purchase orders from a leading U.S. telematics service provider and a current Micronet customer. The TREQ VMX platform is a rugged portable mobile date terminal, installed in the driver's cabin, which enables the monitoring and management of a vehicle fleet.
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PVH GIII | Hot Stocks07:05 EDT PVH Corp., G-III Apparel enter licensing agreement in U.S, Canada - PVH Corp. (PVH) and G-III Apparel (GIII) announced that PVH's Calvin Klein, Inc., or CKI, subsidiary and G-III have entered into a license agreement with an initial term of five years for the design, production and distribution of Calvin Klein Jeans women's jeanswear collections in the United States and Canada. "This business is in addition to the other women's Calvin Klein businesses that are already licensed to G-III by CKI. The arrangement will support PVH's strategy to build a successful women's jeanswear business in North America by leveraging G-III's category and market expertise." The launch of G-III's first women's Calvin Klein Jeans collection is expected for the spring 2020 season.
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CLI | Hot Stocks07:04 EDT Bow Street says Glass Lewis recommends vote for its Mack-Cali nominees - Bow Street, an investment firm that beneficially owns approximately 4.5% of the outstanding shares of common stock of Mack-Cali Realty, announced that Glass, Lewis & Co., has recommended that Mack-Cali shareholders vote the GOLD proxy card "FOR" the election of Bow Street's director nominees MaryAnne Gilmartin and Frederic Cumenal in connection with Mack-Cali's Annual Meeting of Shareholders to be held June 12, 2019. Glass Lewis' recommendation follows Institutional Shareholder Services' recommendation that Mack-Cali shareholders vote the GOLD proxy card "FOR" Bow Street's nominees MaryAnne Gilmartin, Nori Gerardo Lietz and Alan Batkin. In making its recommendation "FOR" Bow Street's nominees Glass Lewis noted: "In short, we believe Mack-Cali's long-term TSR underperformance, multiple shifts in strategies and management through the years, disparate asset portfolio at times, lack of sustainable asset or share value creation, potentially insurmountable financial leverage, persistent trading discount and seemingly limited strategic and financial alternatives, coupled with what appears to remain a somewhat weak corporate governance structure with certain hallmarks of an entrenched board (i.e., founding family shareholder and chairman, lengthy director tenures, long-standing relationships between certain directors, potentially misaligned incentives and interests)...we see ample grounds for shareholders to support incremental board change at this time."
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BMY | Hot Stocks07:03 EDT Bristol-Myers' Opdivo+Yervoy HCC study yields 31% ORR - Bristol-Myers announced first results from the Opdivo plus Yervoy cohort of the Phase 1/2 CheckMate -040 study, evaluating the Immuno-Oncology combination in patients with advanced hepatocellular carcinoma, or HCC, previously treated with sorafenib. With a minimum follow-up of 28 months, the blinded independent central review objective response rate, or ORR, was 31% per Response Evaluation Criteria in Solid Tumors version 1.1. At the time of data cutoff, the median duration of response was 17.5 months. These data will be featured at the ASCO Annual Meeting 2019 in Chicago in a poster display on Monday, June 3. Patient responses were achieved regardless of baseline tumor PD-L1 status. Opdivo plus Yervoy showed an acceptable safety profile and the addition of Yervoy yielded no new safety signals in any treatment arm.
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ARMP | Hot Stocks07:03 EDT Armata Pharmaceuticals announces new patent allowances in Europe, Canada - Armata Pharmaceuticals announced that the company continues to strengthen its intellectual property portfolio with the allowance of two patents by the European Patent Office and one allowance by the Canadian Intellectual Property Office. These newly allowed patents cover various aspects of Armata's bacteriophage program, and its lead product candidate, AP-SA01, which is in development against various diseases or indications caused by Staphylococcus aureus.
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CGEN | Hot Stocks07:02 EDT Compugen presents update on COM701 Phase 1 trial at ASCO - Compugen announced that its ongoing Phase 1 clinical trial evaluating COM701, a first-in-class therapeutic antibody targeting PVRIG, was featured in a trial-in-progress poster at the 2019 ASCO Annual Meeting in Chicago, IL. In a poster titled "A phase I study evaluating COM701 in patients with advanced solid tumors," the company reported that the sixth patient dose cohort of COM701 monotherapy has been completed and that no dose-limiting toxicities were observed in this and prior dose cohorts. Clinical and laboratory assessment for safety and tolerability are ongoing for the next higher dose cohort and for earlier dose cohorts. Furthermore, enrollment in the combination dose escalation of COM701 and Opdivo is ongoing.
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ATXI | Hot Stocks07:00 EDT Avenue Therapeutics trading halted, news pending
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LPX | Hot Stocks06:56 EDT Louisiana-Pacific acquires PSPI, terms not disclosed - Louisiana-Pacific announced that it has acquired Prefinished Staining Product Incorporated, a prefinished siding company located in Green Bay, Wisconsin. PSPI will operate as part of LP's Siding business.
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TROX | Hot Stocks06:53 EDT Tronox announces up to $100M share repurchase program - Tronox announced its board has authorized the repurchase of up to $100M of the company's stock. "This authorization to repurchase shares is consistent with our long-term capital allocation priorities of deleveraging, investing in high-return organic projects to lower our costs and opportunistically returning capital to shareholders," said Jeffry Quinn, chairman and CEO of Tronox. "We believe our shares are drastically undervalued and repurchasing shares at the current price is a high-return use of a portion of our discretionary capital that will not impact our ability to achieve our deleveraging commitments or our timeline to deliver the substantial synergies resulting from the Cristal acquisition."
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SMTS | Hot Stocks06:51 EDT Sierra Metals repurchases royalty at Cusi Silver Mine in Mexico for $4M - Sierra Metals is pleased to announce that the company has agreed to repurchase a royalty on its Cusi Silver Mine in Mexico, from Minera Cusi SA de CV for $4M. The royalty agreement required the company to pay a 3% royalty on the net revenues generated by the mine, less transportation costs, for the life of the mine. The company has already paid $2.5M upon signing the repurchase contract on May 10, and is required to pay a further $1.5M on May 10, 2021. With this repurchase, Sierra Metals will no longer have any royalties on any of its properties or mines, with the exception of those that are legally imposed by the local governments.
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DNN | Hot Stocks06:46 EDT Denison Mines begins environmental impact assessment for Wheeler River project - Denison Mines announced that the Canadian Nuclear Safety Commission, or CNSC, and the Saskatchewan Ministry of Environment, or SK MOE, have accepted the provincial technical proposal and federal project description submitted by Denison for the In-Situ Recovery, or ISR, uranium mine and processing plant proposed for the company's 90% owned Wheeler River Project. Denison also announced that it has executed a series of memoranda of understanding, or MOUs, with indigenous communities in support of the advancement of the project. Acceptance of the project description is the first formal step to officially commence the EIA process in accordance with the requirements of both the Canadian Environmental Assessment Act, 2012 and The Environmental Assessment Act. The project description outlines the major components of the project and the potential interactions with the environment. The CNSC and the SK MOE are expected to carry out a coordinated Federal-Provincial EIA that will follow the spirit of the Canada-Saskatchewan Agreement on Environmental Assessment Cooperation, to the extent possible. The cooperation agreement allows for the production of a single environmental impact statement for the Project, which is intended to present the findings of the EIA in accordance with the requirements of both levels of government. The company said a successful EIA process is critical to securing the approvals necessary to develop and operate a mine in Canada. Accordingly, Denison plans to initiate various studies and assessments as part of the EIA process, which is intended to culminate in the preparation of the Project EIS. The EIA is a planning and decision-making tool, which involves predicting potential environmental effects throughout the project lifecycle at the site, and within the local and regional assessment areas. The EIA objectives are to minimize or avoid adverse environmental effects before they occur and incorporate environmental factors into decision making processes. In addition to predictions made, effective monitoring programs will be developed based on results of the assessments and implemented. The EIA work builds upon the environmental baseline dataset Denison has prepared for the project, and feedback collected from engagement activities completed to date. After careful consideration of the economic results produced by the pre-feasibility study, prepared in accordance with NI 43-101 for the project in late 2018, Denison and the Wheeler River joint venture approved plans to initiate the EIA process as well as the engineering studies and related programs required to advance the development of an ISR mining operation, highlighted by the high-grade Phoenix deposit, with an on-site processing plant.
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PEB | Hot Stocks06:45 EDT Pebblebrook Hotel to sell Hotel Amarano Burbank for about $72.9M - Pebblebrook Hotel Trust announced that it executed a contract to sell the 132-room Hotel Amarano Burbank in Los Angeles, California for approximately $72.9M to a third party. The contracted sale price reflects a 15.8x EBITDA multiple and a 5.7% net operating income capitalization rate (after an assumed annual capital reserve of 4.0% of total hotel revenues) based on the hotel's operating performance for 2018. Based on the trailing 12-month period ended March 2019, the contracted sales price reflects a 16.9x EBITDA multiple and a 5.3% net operating income capitalization rate (after an assumed annual capital reserve of 4.0% of total hotel revenues). Both the EBITDA multiples and net operating income capitalization rates are adjusted for the estimated annualized impact of real estate taxes for California's Proposition 13.
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SM | Hot Stocks06:38 EDT SM Energy promotes Herbert Vogel to COO - SM Energy announces that the company's board has appointed Herbert Vogel to the position of COO. Vogel joined the company in 2012 and has served in the role of Executive Vice President - Operations since August 2014.
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FANH | Hot Stocks06:37 EDT Fanhua provides update on share buyback program - Fanhua announced that it has repurchased 158,393 of its American Depository Shares at an average price of approximately $30.2 per ADS for a total amount of approximately $4.8M for the week of May 27. From March 13, to May 31, it has purchased an aggregate of 1,666,026 ADSs, at an average price of approximately $26.4 per ADS for a total amount of approximately $44M, under its share buyback program to repurchase up to $200M ADSs by December 31, as previously announced by its board of directors in March. Pursuant to its share buyback programs executed in 2018 and 2019, a total of 3,089,800 ADSs have been repurchased at an average price of approximately $26 per ADS for a total amount of approximately $80.4M, as of May 31.
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EPZM | Hot Stocks06:35 EDT Epizyme reports new data from Phase 2 Trial of Tazemetostat at ASCO - Epizyme reported updated data on tazemetostat from the epithelioid sarcoma cohort of its ongoing Phase 2 study in patients with molecularly defined solid tumors. Favorable safety and tolerability have been observed with tazemetostat in this Phase 2 study cohort. The majority of treatment-emergent adverse events were grade 1 or 2, with only 13% of patients experiencing grade 3 or higher treatment-related TEAEs. Reported TEAEs regardless of attribution with an incidence of 10% or greater were fatigue (39%), nausea (35%), cancer pain (32%), decreased appetite (26%), constipation (21%), vomiting (24%), cough and headache (18% each), diarrhea, weight decrease and anemia (16% each), dyspnea (13%) and plural effusion (11.% ). Two percent of patients were dose-reduced due to an adverse event and one patient discontinued treatment due to an adverse event in the Phase 2 cohort. The safety data from the 62 epithelioid sarcoma patients in the study cohort are consistent with the overall safety observed to date in over 800 people in the tazemetostat clinical program. Dr. Shefali Agarwal, chief medical officer of Epizyme said, "We are pleased that the data presented today are consistent with what we have seen throughout our development of tazemetostat for epithelioid sarcoma, demonstrating meaningful clinical activity and good tolerability. Importantly, the totality of these data formed the foundation for our first NDA submission, which we just announced last week. If we are successful, tazemetostat would be the first FDA-approved EZH2 inhibitor."
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EBS | Hot Stocks06:32 EDT Emergent BioSolutions awarded 10-year contract valued at $535M - Emergent BioSolutions announced a contract award by the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services valued at approximately $535M over 10 years for the continued supply of Vaccinia Immune Globulin Intravenous into the U.S. Strategic National Stockpile in support of smallpox preparedness. The contract consists of a one-year base period of performance valued at $23M and nine option years that, when exercised, would bring the total contract value to approximately $535M. The scope of work under the contract includes the collection of plasma, manufacturing, and delivery of finished drug product. During year one, Emergent will use plasma provided by the U.S. government to manufacture VIGIV doses, while all subsequent years will involve Emergent-led plasma collection and production efforts resulting in higher annual revenue potential. VIGIV is the only therapeutic licensed by the FDA for the treatment of complications due to smallpox vaccination and has been stockpiled at a ratio of one dose of VIGIV per 10,000 doses of first or second generation smallpox vaccine.
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DD | Hot Stocks06:28 EDT DuPont announces $2B share buyback program - DuPont announced that its board of directors approved a $2B share buyback program which expires on June 1, 2021. Under the stock buyback program, shares of the company's common stock may be repurchased periodically in open market or private transactions. The actual timing, number and value of shares repurchased under the program will be determined by management at its discretion and will depend on a number of factors, including the market price of DuPont's common stock, general market and economic conditions, applicable legal requirements and other business considerations.
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HUM... | Hot Stocks06:27 EDT Humana confirms it will not propose merger with Centene - In a regulatory filing, Humana (HUM) said, "Humana's long-standing policy is not to comment on rumors or speculation regarding possible M&A activity. However, in light of the significant investor speculation and persistent market rumors regarding the company's intentions with respect to pursuing a combination with Centene (CNC), the company has chosen to make a one-time, limited exception to its no-comment policy (which continues in effect) and confirm that the company will not make a proposal to combine with Centene as an alternative to Centene's proposed transaction with WellCare Health Plans (WCG). The company does not intend to make any further statement regarding the foregoing."
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HUM CNC | Hot Stocks06:25 EDT Humana confirms it will not propose merger with Centene
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EQT | Hot Stocks06:18 EDT Rice Team sends additional letter to EQT Corporation shareholders - The Rice Team, shareholders of EQT Corporation, sent an additional letter to fellow EQT shareholders emphasizing the necessity for new vision and leadership in order to realize the full potential of the merger with Rice Energy. Also in the letter, the Rice Team's exceptional independent director candidates for the EQT Board introduce themselves to shareholders and offer their perspectives on the strengths of the Rice Team and why there is a pressing need for transformational change at EQT. Reference Link
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FHL | Hot Stocks06:16 EDT Futu obtains clearing license in U.S. - Futu Holdings recently announced that its wholly-owned subsidiary in the U.S., Futu Clearing Inc., has been officially granted a clearing license by the United States SEC and the Financial Industry Regulatory Authority. With the clearing license and Futu's proprietary clearing system, the company will be able to provide clearing, settlement and asset custody services to customers and other introducing brokers in the U.S, which will enable Futu to capture the full cycle of client trades and maintain custody of its clients' assets.
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KXIN | Hot Stocks06:15 EDT Kaixin Auto receives delisting notice from Nasdaq for warrants - Kaixin Auto announced receipt of a delisting notice from Nasdaq, which informed the company that, absent an appeal, trading in the company's warrants will be suspended from Nasdaq at the opening of business on June 11. The company received notification on May 31, indicating that the company has not demonstrated that it meets the minimum 400 round lot holder requirement for initial listing of its warrants, following the completion of the company's business combination on April 30. This action does not impact listing of the company's ordinary shares, which will continue to trade on the Nasdaq.
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MAXR | Hot Stocks06:14 EDT Maxar Technologies awarded multiple contracts worth more than $95M - Maxar Technologies announced that it was awarded multiple contracts in the first quarter to provide innovative Earth intelligence solutions to U.S. government agencies, with a total value of more than $95M.
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SRC... | Hot Stocks06:12 EDT Spirit Realty comments on recent announcement by Spirit MTA REIT - Spirit Realty Capital (SRC) commented on the announcement by Spirit MTA REIT (SMTA), externally managed by Spirit, that SMTA's Board of Trustees has reached a definitive agreement to sell the assets held in Master Trust 2014. The closing of the sale is subject to customary conditions, including the receipt of SMTA shareholder approval, and is expected to occur in the later part or end of the third quarter. "As I reiterated in my recent annual letter to Spirit stockholders, the resolution of SMTA's accelerated strategic process is one of the most important 2019 initiatives for SRC. At conclusion of the announced $2.4 billion sale by SMTA, Spirit will be a simplified, pure-play, triple-net REIT. As the external manager of SMTA, we remain focused on helping SMTA's Board of Trustees finalize the liquidation of the remaining SMTA assets. I want to thank SMTA's independent Board of Trustees, the entire Spirit team and the Spirit Board of Directors for their hard work and attention over the past two years," stated Jackson Hsieh, President and CEO of Spirit. In conjunction with the completion of the proposed transaction, Spirit has agreed to: Terminate the existing asset management agreement with SMTA (and as a result of this termination, SMTA will not be required to deliver notice 180 days in advance of termination or enter into an eight month transition services period); the property management agreement for Master Trust 2014 will terminate in connection with the redemption of the Master Trust 2014 notes; Sell the fee interest in three Spirit owned Pilot Travel Centers for $55M in gross proceeds at a 5.7% cash capitalization rate, subject to satisfaction of certain conditions; Waive Spirit's rights to receive any potential promote fee; Enter into an interim asset management agreement with SMTA whereby Spirit will receive $1M during the initial one-year term and $4 million for any renewal one-year term, plus certain cost reimbursements, to manage and liquidate the remaining SMTA assets; such agreement is terminable at any time by SMTA and by Spirit after the initial one year term, in each case without a termination fee. Assuming a closing at the end of the third quarter of 2019, Spirit expects to receive: Termination fee of approximately $48M ($35M net of estimated tax); $150M for the repurchase of Spirit's preferred equity investment in SMTA; Approximately $28M in net proceeds from the sale of the Pilot Travel Centers (net of approximately $27M in related party note repayments); Approximately $34M for the redemption of Master Trust 2014 notes held by Spirit.
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GBX | Hot Stocks06:08 EDT Greenbrier appoints Adrian Downes CFO - Greenbrier announced that its senior VP and acting CFO, Adrian Downes, has been appointed CFO. In addition to continuing his duties managing Greenbrier's accounting, tax, internal audit and IT functions, Downes will also serve as the company's principal financial and accounting Oofficer. He continues to report to Lorie Tekorius, executive VP and COO. Downes has more than 30 years of accounting and finance experience in a variety of industries, both with publicly held and privately held companies. Before joining Greenbrier in 2013 as its CAO, he was executive VP and CFO for Knowledge Universe, a private-equity owned early childhood education provider.
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AAC | Hot Stocks06:07 EDT AAC Holdings engages Cantor Fitzgerald as financial advisor - AAC Holdings announced that it has formally engaged the investment banking firm Cantor Fitzgerald as its exclusive financial advisor with respect to potential strategic corporate transactions involving the company's real estate and other assets, as well as potential recapitalization or refinancing transactions. Earlier this year, AAC closed a $30M incremental term loan. The company had previously announced its intent to explore strategic transactions including those involving the company's real estate.
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UPL | Hot Stocks06:07 EDT Ultra Petroleum backs FY19 production guidance 240-250 Bcfe - Production guidance for full-year 2019 remains unchanged at 240-250 Bcfe while capital investment guidance for full-year 2019 is reduced by $15M to a new range of $305M-$335M. In May, the company drilled 3 wells with spud to total depth times of less than 6 days, compared to its first quarter average of 8.05 days. Improved drilling cycle-time performance and higher working interest in wells planned for the remainder of the year provides for 2019 production guidance to remain unchanged while 2019 capital investment is reduced by approximately 5%. "Our team continues to improve drilling cycle-time performance. As a result, we are drilling wells faster and can accomplish our 2019 plan with the adjustment down to two operated rigs for the remainder of the year. With increased drilling efficiency, along with higher working interest in wells planned for the remainder of the year, we are maintaining full year production guidance, reducing capital investment and moving the Company closer to its projection of free cash flow in the fourth quarter of 2019," said Ultra Petroleum's President and CEO Brad Johnson.
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SHOS | Hot Stocks06:06 EDT Sears Hometown and Outlet to be acquired by Transform Holdco for $2.25 per share - Transform Holdco announced that they have entered into a definitive merger agreement whereby Transform will acquire the outstanding shares of Sears Hometown not owned by ESL Investments and its affiliates for a price of $2.25 per share in cash, subject to an upward adjustment in the event a sale of Sears Hometown's Outlet Segment has occurred that satisfies criteria specified in the merger agreement. ESL Investments, Inc. and its affiliates, the majority owners of Transform, presently hold 58% of the outstanding shares of Sears Hometown. Under the terms of the merger agreement, Sears Hometown has a specified period of time in which it can market and sell its Sears Outlet and Buddy's Home Furnishing Stores businesses to a third party for not less than $97.5M. If the Outlet Segment is sold in accordance with the terms of the merger agreement, it will not be acquired by Transform in the acquisition of Sears Hometown. At the completion of the acquisition of Sears Hometown, each share of Sears Hometown's outstanding common stock not owned by ESL Investments, Inc. and its affiliates will be converted into the right to receive a base amount in cash equal to $2.25 per share. If Sears Hometown completes a sale of the Outlet Segment in accordance with the terms of the merger agreement, this base amount will be subject to an upward adjustment equal to the excess, if any, of the net proceeds received by Sears Hometown as a result of any sale of the Outlet Segment over $97.5M, divided by the aggregate number of shares of Sears Hometown common stock and unvested Sears Hometown restricted stock units issued and outstanding as of the closing of the merger transaction. Sears Hometown must enter into an agreement to sell the Outlet Segment no later than August 24, and the sale must be completed by October 23. Under the terms of the Merger Agreement, Transform will have the opportunity to match the economic terms of any proposed sale of the Outlet Segment to a third party that is expected to result in net proceeds to Sears Hometown of less than $120M.
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CS | Hot Stocks06:05 EDT Credit Suisse names Zhenyi Tang as CEO of China - Credit Suisse announced the appointment of Zhenyi Tang as CEO China. Based in Beijing, Tang will drive the execution of Credit Suisse's strategy in China across its business and regulatory activities. He will have oversight of the bank's onshore entities, and report to Helman Sitohang, CEO Asia Pacific of Credit Suisse. Tang will join Credit Suisse this month and will be a member of the bank's Asia Pacific Operating Committee. His appointment follows Credit Suisse's announcement in April of its plan to increase its stake in its onshore securities joint venture to 51%, subject to regulatory approvals, and the recent appointment of Shan Li to the Board of Directors of Credit Suisse Group AG. Li is the second Asia-based member of the Board of Directors, alongside Kai S. Nargolwala. In the past eight years, Tang held various executive roles at CITIC Group in Beijing and Hong Kong, most recently as Chairman and Executive Committee member of CLSA Limited in Hong Kong, a wholly-owned subsidiary of CITIC Securities.
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DD | Hot Stocks06:05 EDT DuPont begins regular way trading on NYSE - DuPont announced its debut as an independent company following the successful separation of its agriculture division through the spin-off of Corteva. The company was formerly known as DowDuPont. DuPont common stock begins regular way trading on the New York Stock Exchange, or NYSE. DuPont has a presence in over 70 countries, with headquarters in Wilmington, Delaware, and operates approximately 170 manufacturing sites, over 10 global R&D centers and 10 global innovation centers. Immediately following the distribution of Corteva common stock on June 1, DuPont completed a 1-for-3 reverse stock split and as a result DuPont common stockholders now hold one share of common stock of DuPont for every three shares of DowDuPont common stock held prior to the reverse stock split.
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CUO | Hot Stocks06:04 EDT Continental Materials acquires American Wheatley and Global Flow Products - Continental Materials announces the acquisition of American Wheatley HVAC and Global Flow Products based in Broken Arrow, Oklahoma. With this acquisition, CMC expands its commercial HVAC reach and capabilities, and adds manufacturing expertise in a number of new markets. GFP is a family-owned business with over 40 years' experience in providing American Wheatley HVAC branded products, including a broad line of ASME pressure vessels, custom fabricated products, valves, strainers and other hydronic accessories, for discerning commercial HVAC customers. Terms of the transaction were not disclosed.
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HPT SMTA | Hot Stocks06:03 EDT Hospitality Properties to buy net lease portfolio from Spirit MTA REIT for $2.4B - Hospitality Properties Trust (HPT) announced it entered into a definitive agreement to acquire a net lease portfolio from Spirit MTA REIT (SMTA) for $2.4B in cash, excluding transaction costs. The portfolio consists of 774 service-oriented retail properties net leased to tenants in 22 different industries. The portfolio has a weighted average remaining lease term of 8.6 years, a weighted average property level rent coverage of 2.68x and annual cash rent of $172M as of March 31. This acquisition excludes SMTA's assets leased to certain bankrupt tenants. HPT expects this transaction to be accretive to annualized Normalized Funds From Operations, or FFO, per share in 2020. Based on estimated GAAP net operating income and pending completion of HPT's accounting analysis, HPT believes the acquisition capitalization rate will be approximately 7.2%. HPT's accretion estimate for 2020 assumes that debt incurred with this transaction is refinanced with longer term debt financing at current market rates and is after expected asset sales. HPT does not plan to issue common shares in connection with this transaction. The purchase price is subject to certain adjustments. The transaction is subject to approval by SMTA shareholders and other customary conditions and is expected to close in the third quarter.
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HPT SMTA | Hot Stocks06:01 EDT Hospitality Properties to buy net lease portfolio from Spirit MTA REIT for $2.4B
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IFNNY CY | Hot Stocks05:59 EDT Infineon to acquire Cypress Semi in deal with enterprise value of EUR9B - Infineon Technologies (IFNNY) and Cypress Semiconductor Corporation (CY) announced that the companies have signed a definitive agreement under which Infineon will acquire Cypress for $23.85 per share in cash, corresponding to an enterprise value of EUR9B. The companies said that expected economies of scale will create cost synergies of EUR180M per annum by 2022. The complementary portfolios will enable the offering of further chip solutions with a revenue synergies potential of more than EUR1.5B per annum in the long term. The offer price represents a 46% premium to Cypress's unaffected 30-day volume-weighted average price during the period from 15 April to 28 May 2019, the last trading day prior to media reports regarding a potential sale of Cypress. Cypress expects to continue its quarterly cash dividend payments until the transaction closes. This includes Cypress's previously announced quarterly cash dividend of 11c per share, payable on July 18, 2019 to holders of record of Cypress's common stock at the close of business on June 27, 2019. The funding of the acquisition is fully underwritten by a consortium of banks. Infineon is committed to retaining a solid investment grade rating and, consequently, Infineon intends to ultimately finance approximately 30 percent of the total transaction value with equity and the remainder with debt as well as cash on hand. The financial policy to preserve a strategic cash reserve remains in place. The acquisition is subject to approval by Cypress's shareholders and the relevant regulatory bodies as well as other customary conditions. The closing is expected by the end of calendar year 2019 or early 2020. Hassane El-Khoury, President and CEO of Cypress, said: "The Cypress team is excited to join forces with Infineon to capitalize on the multi-billion dollar opportunities from the massive rise in connectivity and computing requirements of the next technology waves. This announcement is not only a testament to the strength of our team in delivering industry-leading solutions worldwide, but also to what can be realized from uniting our two great companies. Jointly, we will enable more secure, seamless connections, and provide more complete hardware and software sets to strengthen our customers' products and technologies in their end markets. In addition, the strong fit of our two companies will bring enhanced opportunities for our customers and employees."
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IFNNY CY | Hot Stocks05:57 EDT Infineon to acquire Cypress Semiconductor for $23.85 per share
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VICL | Hot Stocks05:47 EDT Vical and Brickell Biotech announce merger agreement - Vical and Brickell Biotech announced they entered into a definitive merger agreement under which Brickell would merge with a wholly-owned subsidiary of Vical in an all-stock transaction. The Merger would create a pharmaceutical company focused on developing novel and differentiated prescription therapies addressing unmet patient needs in hyperhidrosis, cutaneous T-cell lymphoma, psoriasis, and other debilitating dermatologic disorders. Brickell's lead pipeline asset, sofpironium bromide, is a pivotal Phase 3-ready topical soft anticholinergic intended for axillary hyperhidrosis. Brickell's development partner, Kaken Pharmaceutical, has reported positive Phase 3 results in a clinical trial conducted in Japan. Upon closing of the transaction, the combined company would operate under the name, Brickell Biotech, Inc. and trade on the Nasdaq Capital Market under a new ticker symbol still to be determined. Under the terms of the Merger, it is anticipated that existing Vical stockholders will own 40% of the combined company and Brickell stockholders will own 60% of the combined company, in each case upon completion of the Merger and subject to assumptions regarding the calculation of the fully diluted shares of the parties. The ownership split is based on a $60 million valuation for Brickell and a $40 million valuation for Vical, a premium to the 30-day volume weighted average share price of Vical. The actual allocation between the two groups of stockholders is subject to adjustment based on Vical's and Brickell's respective net cash and net working capital balances prior to the completion of the Merger. The transaction has been approved by the boards of directors of both companies and the required percentage of stockholders of Brickell needed to approve the transaction. The Merger is anticipated to close in the third quarter of 2019, subject to customary closing conditions, including approval of the Merger by the stockholders of Vical, and the satisfaction of the closing conditions to the Funding Agreement. An affiliate of NovaQuest Capital Management has committed up to $25 million in near-term research and development funding to Brickell following the closing of the Merger. Immediately following the closing of the Funding Agreement, the combined company will issue a warrant to NovaQuest to purchase shares of Vical common stock in an amount based on 10% warrant coverage on the $25 million funding commitment and the exchange ratio for the Merger. The combined company intends to use proceeds from NovaQuest, in addition to Vical's cash balance expected to be approximately $35 million at the closing of the Merger, to primarily fund the development of sofpironium bromide through Phase 3 clinical trials in axillary hyperhidrosis. Following the Merger, the combined company will be led by the current Brickell management team, including, Robert Brown as CEO, Andy Sklawer, Co-Founder and COO, Deepak Chadha, Chief R&D Officer, R. Michael Carruthers, CFO, Gary Walker, Chief Marketing Officer, and David McAvoy, General Counsel. The corporate headquarters will be located in Boulder, Colorado.
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NVS INCY | Hot Stocks05:42 EDT Novartis to present new data, trial updates in NSCLC at ASCO - Novartis (NVS) announced new data and clinical trial updates in non-small cell lung cancer, or NSCLC, at the ASCO 2019 Annual Meeting. This includes primary efficacy results from the GEOMETRY mono-1 Phase II clinical trial demonstrating that investigational MET inhibitor capmatinib shows promise as a potential treatment option for patients with locally advanced or metastatic NSCLC that harbor MET exon-14 skipping mutation. There are currently no approved targeted therapies to treat this particularly aggressive form of NSCLC. Results of the Phase II study will be presented at an oral session at ASCO. Primary analysis of investigational capmatinib in the GEOMETRY mono-1 study demonstrates promising efficacy in patients with locally advanced or metastatic NSCLC harboring MET exon-14 skipping mutation. Overall response rate among patients receiving capmatinib was 68% for treatment-naive and 41% for previously treated patients; median duration of response was also clinically meaningful irrespective of prior line of therapy. Capmatinib is an investigational, oral and selective MET inhibitor licensed to Novartis by Incyte (INCY) in 2009. Under the Agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.
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NVS | Hot Stocks05:36 EDT Novartis to present new data, trial updates in NSCLC at ASCO - Novartis announced new data and clinical trial updates in non-small cell lung cancer, or NSCLC, at the ASCO 2019 Annual Meeting. This includes primary efficacy results from the GEOMETRY mono-1 Phase II clinical trial demonstrating that investigational MET inhibitor capmatinib shows promise as a potential treatment option for patients with locally advanced or metastatic NSCLC that harbor MET exon-14 skipping mutation. There are currently no approved targeted therapies to treat this particularly aggressive form of NSCLC. Results of the Phase II study will be presented at an oral session at ASCO. Primary analysis of investigational capmatinib in the GEOMETRY mono-1 study demonstrates promising efficacy in patients with locally advanced or metastatic NSCLC harboring MET exon-14 skipping mutation. Overall response rate among patients receiving capmatinib was 68% for treatment-naive and 41% for previously treated patients; median duration of response was also clinically meaningful irrespective of prior line of therapy.
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RHHBY NVS | Hot Stocks05:32 EDT Genentech: POLYP 1, POLYP 2 Phase III trials met co-primary, secondary endpoints - Genentech, a member of the Roche Group (RHHBY), announced positive topline data from two Phase III multicenter studies evaluating Xolair for the treatment of adults with chronic rhinosinusitis with nasal polyps, or CRSwNP, who have not adequately responded to intranasal corticosteroids. The POLYP 1 and POLYP 2 Phase III trials met both co-primary endpoints and key secondary endpoints. Xolair, an injectable biologic medicine designed to target and block immunoglobulin E, or IgE, was shown to be well tolerated and the safety profile was consistent with that observed in previous studies in people with moderate to severe allergic asthma and chronic idiopathic urticaria. The co-primary endpoints of POLYP 1 and POLYP 2 were change from baseline in Nasal Polyp Score and change from baseline in average daily Nasal Congestion Score over 24 weeks. Xolair demonstrated statistically significant and clinically relevant improvements in both of these co-primary outcomes. Patients enrolled in the study included those with and without a history of surgery. Key secondary endpoints were met, including improvement in smell, post-nasal drip, runny nose and the Sino-Nasal Outcome Test-22, or SNOT-22, health-related quality of life assessment. In the U.S., Genentech and Novartis Pharmaceuticals (NVS) work together to develop and co-promote Xolair.
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RHHBY | Hot Stocks05:31 EDT Genentech: POLYP 1, POLYP 2 Phase III trials met co-primary, secondary endpoints - Genentech, a member of the Roche Group, announced positive topline data from two Phase III multicenter studies evaluating Xolair for the treatment of adults with chronic rhinosinusitis with nasal polyps, or CRSwNP, who have not adequately responded to intranasal corticosteroids. The POLYP 1 and POLYP 2 Phase III trials met both co-primary endpoints and key secondary endpoints. Xolair, an injectable biologic medicine designed to target and block immunoglobulin E, or IgE, was shown to be well tolerated and the safety profile was consistent with that observed in previous studies in people with moderate to severe allergic asthma and chronic idiopathic urticaria. The co-primary endpoints of POLYP 1 and POLYP 2 were change from baseline in Nasal Polyp Score and change from baseline in average daily Nasal Congestion Score over 24 weeks. Xolair demonstrated statistically significant and clinically relevant improvements in both of these co-primary outcomes. Patients enrolled in the study included those with and without a history of surgery. Key secondary endpoints were met, including improvement in smell, post-nasal drip, runny nose and the Sino-Nasal Outcome Test-22, or SNOT-22, health-related quality of life assessment.
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BA SPR | Hot Stocks05:22 EDT Boeing says one batch of slat tracks found to have a potential nonconformance - Boeing (BA) said yesterday in a statement that it is working with the Federal Aviation Administration and has contacted 737 operators advising them to inspect the slat track assemblies on certain airplanes. "One batch of slat tracks with specific lot numbers produced by a supplier was found to have a potential nonconformance. If operators find the parts in question, they are to replace them with new ones before returning the airplane to service," Boeing announced. Slat tracks are used to guide the slats located on the leading edge of an airplane's wings. Boeing has not been informed of any in-service issues related to this batch of slat tracks. Boeing is now "staging replacement parts at customer bases to help minimize aircraft downtime while the work is completed. Once the new parts are in hand, the replacement work should take one to two days. Boeing will also issue a safety service bulletin outlining the steps to take during the inspections." Boeing has identified 21 737 NGs most likely to have the parts in question. A separate service bulletin will go to 737 MAX operators to do inspections before the MAX fleet returns to service, added the company. Boeing identified 20 737 MAX airplanes that are most likely to have the parts in question. Operators will be asked to check an additional 159 MAXs to ensure a thorough assessment. Boeing has identified Spirit AeroSystems (SPR) as the supplier of the faulty slat tracks, according to Bloomberg. Reference Link
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FTD | Hot Stocks05:19 EDT FTD Companies expects common stock to be delisted from Nasdaq - FTD Companies expects that the company's common stock will be delisted from the Nasdaq Stock Market for non-compliance with marketplace rules as a result of the Chapter 11 filing. In addition, based on the values for the company's businesses contemplated by the potential asset sales referred to above, the company expects that existing company stockholders will receive no recovery at the end of the court-supervised restructuring process, consistent with legal priorities.
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FTD | Hot Stocks05:18 EDT FTD Companies files voluntary Chapter 11 petitions - FTD Companies announced that the company and substantially all of its domestic subsidiaries have filed voluntary petitions commencing cases under Chapter 11 in the U.S. Bankruptcy Court for the District of Delaware to facilitate the completion of strategic initiatives resulting from the company's previously announced strategic review. The company intends to use the court-supervised restructuring process to support and protect its ongoing business operations, including its relationships with member florists and business partners, to provide an efficient and binding mechanism for the potential sales of its businesses and to address a near-term debt maturity. The company is operating in the ordinary course and remains focused on supporting its extensive network of member florists and business partners connected by its iconic FTD brand in North America and Latin America. The company's other businesses, including ProFlowers, Shari's Berries and Personal Creations, are also continuing to provide floral, specialty foods, gifts and related products to consumers. The company has received commitments for up to approximately $94.5M in debtor-in-possession, or DIP, financing from a syndicate comprised of its existing lenders. Upon approval by the Bankruptcy Court, this financing, combined with cash generated from the company's ongoing operations, will be used to, among other things, support the business during the court-supervised restructuring process. The company has filed pleadings, referred to as "first day motions," with the Bankruptcy Court. The relief sought in the first day motions is expected to enable the company to continue to support its business operations during the restructuring process, including by continuing payments and services to member florists and business partners without interruption, managing its continuing relationships with vendors and customers and paying wages and benefits for continuing employees. The company has entered into a definitive asset purchase agreement with an affiliate of Nexus Capital, a California-based private equity sponsor, to acquire the company's North America and Latin America florist and consumer business, including ProFlowers. The purchase price is $95M in cash, subject to customary adjustments. The company also announced that it is restructuring its ProFlowers business to better support the FTD florist network and to reduce costs. Under the new operating model, floral order fulfilment and distribution for ProFlowers are being transitioned to the FTD florist network and third-party fulfilment partners. The ProFlowers website will continue to serve customers and process orders. Under the asset purchase agreement with Nexus Capital, Nexus Capital would acquire the as-restructured ProFlowers business. The company has sold its Interflora business in the U.K. to a subsidiary of The Wonderful Company for $59.5M in cash. The Interflora business operated independently from FTD's North America and Latin America businesses and it is not part of the Chapter 11 filing.
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BA | Hot Stocks05:16 EDT FAA says some Boeing 737 NG and MAX models contain improper slat tracks - The Federal Aviation Administration announced yesterday in a statement Boeing (BA) has informed the agency that certain 737 NG and 737 MAX leading edge slat tracks may have been improperly manufactured and may not meet all applicable regulatory requirements for strength and durability. "Following an investigation conducted by Boeing and the FAA Certificate Management Office, we have determined that up to 148 parts manufactured by a Boeing sub-tier supplier are affected. Boeing has identified groups of both 737NG and 737MAX airplane serial numbers on which these suspect parts may have been installed," the FAA said. 32 NG and 33 MAX are affected in the U.S. Affected worldwide fleet are 133 NG and 179 MAX aircraft. The affected parts may be susceptible to premature failure or cracks resulting from the improper manufacturing process, it added. "Although a complete failure of a leading edge slat track would not result in the loss of the aircraft, a risk remains that a failed part could lead to aircraft damage in fight," says the FAA. The agency will issue an Airworthiness Directive to mandate Boeing's service actions to identify and remove the discrepant parts from service. Operators of affected aircraft are required to perform this action within 10 days. The FAA today also alerted international civil aviation authorities of this condition and required actions. Shares of Boeing are down $4.60 to $337.01 in premarket trading. []:[https://www.faa.gov/news/updates/?newsId=93206]
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BX | Hot Stocks05:12 EDT Blackstone to buy U.S. logistics assets from GLP for $18.7B - GLP and Blackstone announced that they have entered into an agreement for Blackstone to acquire assets from three of GLP's U.S. funds for a purchase price of $18.7B. This overall transaction totals 179M square feet of urban, infill logistics assets, nearly doubling the size of Blackstone's existing U.S. industrial footprint. Blackstone Real Estate's global opportunistic BREP strategy will acquire 115M square feet for $13.4B and its income-oriented non-listed REIT, Blackstone Real Estate Income Trust, will acquire 64M square feet for $5.3B.
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BX | Hot Stocks05:10 EDT Blackstone to buy U.S. logistics assets from GLP for $18.7B
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