Stockwinners Market Radar for October 10, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
SAP... | Hot Stocks19:30 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: SAP (SAP), up 3.3%... ALSO HIGHER: Synthesis Energy (SES), up 82.7% after it agreed to acquire Australian Future Energy... Roku (ROKU), up 5% after RBC Capital analyst Mark Mahaney upgraded the stock to Outperform from Sector Perform... ALSO LOWER: ExOne (XONE), down 21% after it revised its Q3 revenue guidance.
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SAP | Hot Stocks19:00 EDT SAP CEO Bill McDermott to step down - SAP announced that Bill McDermott has decided not to renew his contract and is stepping down from his position as chief executive officer. In activating the company's long-term succession plan, SAP Executive Board Members Jennifer Morgan and Christian Klein have been appointed co-chief executive officers, effective immediately, with the approval of the Supervisory Board of SAP SE. McDermott will remain in an advisory capacity until the end of the year to ensure a smooth transition. McDermott joined SAP in 2002.
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HRL | Hot Stocks18:26 EDT Hormel Foods CEO: We are a food company and proud of it - In an interview on CNBC's Mad Money, Hormel Foods CEO Jim Snee said: SPAM is an iconic brand and has never gone away... SPAM is the foundation of the company... Pumpkin Spice SPAM sold out in seven hours... The consumer is changing faster than they ever have... Innovation is the lifeblood of our company... We are focused on growing our business organically and making disciplined acquisitions... We feel we have amazing brands... We think the trade war with China is a short-term problem... We know how to navigate pricing and manage supply... Food has a way of connecting people like nothing else can..
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TRPX | Hot Stocks18:16 EDT Therapix Biosciences provides update on merger with Destiny Biosciences - Therapix Biosciences announced an update on its planned merger with Destiny Biosciences. The company expects to execute a definitive agreement pertaining to the merger during Q3. According to the Letter of Intent, the parties agreed to allow until October 31 to complete the definitive agreement before abandoning the transaction. The company's board is willing to provide Destiny with additional time to complete its due diligence process. In addition, Destiny has retained an investment bank to carry out a relative valuation analysis of both companies to assist the Destiny Board of Directors in connection with the merger. Destiny informed the company that the valuations are being completed, but initial draft results of the valuations support the transaction and the relative pricing.
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GILD GLPG | Hot Stocks18:01 EDT Gilead, Galapagos announces efficacy, safety results of Filgotinib - Gilead Sciences (GILD) and Galapagos (GLPG) announced that Week 52 data from the registrational Phase 3 FINCH 1 and FINCH 3 trials of filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of moderately-to-severely active rheumatoid arthritis are consistent with and support the efficacy, safety and tolerability profiles demonstrated in the Week 12 and 24 analyses presented earlier this year. "We are encouraged by the durability of both the efficacy and safety profiles of filgotinib seen in these studies," said John Sundy, MD, PhD, Senior Vice President, Inflammation and Respiratory Diseases, Gilead Sciences. "These data suggest that filgotinib if approved, may play an important role in helping people living with rheumatoid arthritis achieve sustained, clinically meaningful responses." "These recent updates from the FINCH 1 and 3 trials continue to provide consistent evidence to support filgotinib's profile in RA patients. In the second half of the FINCH 1 and FINCH 3 trials, filgotinib exhibited the same favorable safety profile seen in the first 24 weeks, including similar rates of thrombotic events as previously observed, as well as persistent efficacy," said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.
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SES | Hot Stocks17:52 EDT Synthesis Energy Systems to acquire Australian Future Energy for $36M - Synthesis Energy Systems announced that it has signed a definitive Merger Agreement, whereby Australian Future Energy Pty Ltd, a private company incorporated in Brisbane, Australia in 2014, will merge with a wholly owned subsidiary of SES. As a result of the transaction, AFE will become a wholly owned subsidiary of SES. SES currently holds approximately 35% of the issued capital of AFE. Upon closing and subject to the terms and conditions of the Merger Agreement, SES will issue 3,875,000 new shares of SES common stock for the acquisition of AFE. Each holder of AFE ordinary shares will receive one share of SES's common stock for approximately each 24.44 ordinary shares of AFE. The current other major shareholders of AFE, representing approximately 90% of the current issued capital of AFE, have formally pre-committed their shares in support of the merger transaction. The mutually agreed purchase value of AFE is approximately $36M, based on $6 per share of SES common stock to be issued. In connection with entry into the Merger Agreement, SES also announces that it has offered to acquire 100% of the issued capital of Batchfire Resources Pty Ltd, owner of the Callide Mine in Queensland, Australia, via the issuance and exchange of one share of SES common stock for each ten ordinary shares of Batchfire. SES has set a minimum participation level by Batchfire shareholders of 25% inclusive of SES's own 7.37% holding in Batchfire. Each participating Batchfire shareholder will enter into a Share Exchange Agreement with SES and, to date, SES has received signed Share Exchange Agreements from 33% of Batchfire shareholders, inclusive of SES Group's ownership, meeting the minimum participation level. The Batchfire share exchange is subject to conditions specified in the Share Exchange Agreements, including the completion of Batchfire's pre-emptive rights procedure and the consummation of the transactions contemplated by the Merger Agreement. The valuation basis for the offer to acquire Batchfire is based on $6 per each share of company common stock placing the value of 100% of Batchfire at approximately $80M. As part of the transaction, at merger closing, Kerry Parker, current CEO of AFE, will be appointed as President and Chief Executive Officer of SES, and Ron Higson, current COO of AFE, will be appointed as Chief Operating Officer of SES. An appointment of a new Chief Financial Officer for SES will be named at, or prior to, closing. Additionally, Edek Choros, Stephen Lonie, and Mr. Richard Barker will be appointed to the SES Board of Directors. Robert W. Rigdon, a long-time SES executive who has served as Deputy Chairman and Director of AFE since its inception and is the current Vice Chairman, President and CEO of SES, will remain on the board of SES. Once convened, the Board of Directors is expected to appoint one or more additional, independent directors. All other current directors of SES will resign their positions at merger closing.
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KSS | Hot Stocks17:47 EDT Kohl's CFO Bruce Besanko to step down on November 1, Jill Timm to succeed - Kohl's announced that Bruce Besanko has decided to retire from Kohl's at the end of the fiscal year and will step down from his position as CFO, effective November 1. At that time, Jill Timm, Kohl's Executive Vice President of Finance, will be promoted to CFO. Besanko will remain in a Senior Advisor role until he departs the company to assist with the CFO transition and provide support for current company initiatives. In the CFO role, Timm will oversee Kohl's financial planning and analysis, investor relations, financial reporting, accounting operations, tax and treasury. She will report directly to the CEO. Timm joined Kohl's in 1999, holding progressive leadership positions across several areas of finance, most recently as Executive Vice President of Finance. She has more than 25 years of finance experience in financial planning, analysis, accounting, capital planning, investor relations, treasury and tax.
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NOC | Hot Stocks17:45 EDT Northrop Grumman awarded on $986M Air Force contract - Northrop Grumman has been awarded on a combined ceiling $986M multiple-award, indefinite-delivery/indefinite-quantity, firm-fixed-price contract with a nine year ordering period. The contract seeks to capitalize on the emerging small launch providers while providing dedicated and primary launch services to the Department of Defense and other government agencies. The program allows for the rapid acquisition of launch services to meet mission requirements for payloads greater than 400 pounds, enabling launch to any orbit within 12-24 months from task order award. Work will be performed at the contractor facilities and a variety of government launch sites, depending on mission requirements. This award is the result of a competitive source acquisition and nine offers were received. FY19 space procurement funds in the amount of $50,000 are being obligated at time of award. The Space and Missile Systems Center is the contracting activity.
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NWBO | Hot Stocks17:42 EDT Northwest Biotherapeutics enters into settlement with SEC - Northwest Biotherapeutics announced that it has entered into a settlement with the SEC. As previously reported, the company has been investigated by the SEC and has cooperated with the investigation. The company has now successfully entered into a settlement agreement with the SEC under Rule 13a-15. Under the settlement, in which the company neither admits nor denies any violations, the company will pay a fine of $250,000 in connection with past weaknesses in its internal controls, and the company will retain an additional independent consultant to help the company remediate its remaining weaknesses.
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GERN | Hot Stocks17:32 EDT Geron announces first patient has been dosed in IMerge Phase 3 clinical trial - Geron Corporation announced that the first patient has been dosed in the IMerge Phase 3 clinical trial to evaluate imetelstat, a first-in-class telomerase inhibitor, in lower risk myelodysplastic syndromes, or MDS. IMerge is a two-part Phase 2/3 clinical trial of imetelstat in transfusion dependent patients with lower risk MDS who are relapsed after or refractory to erythropoiesis-stimulating agents, or ESAs. The Phase 3 is planned to enroll approximately 170 patients in a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that imetelstat improves the rate of red blood cell transfusion independence, or TI. The primary endpoint is 8-week TI rate, which is defined as the proportion of patients achieving transfusion independence during any consecutive eight weeks since entry into the trial. Key secondary endpoints include the rate of transfusion independence lasting at least 24 weeks, or 24-week TI rate, durability of transfusion independence and the amount and relative change in transfusions. Based upon current planning assumptions, Geron expects top-line results for the IMerge Phase 3 clinical trial to be available by mid-year 2022.
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UDR | Hot Stocks17:19 EDT UDR CEO sells 40,000 common shares - In a regulatory filing, UDR chairman and CEO Thomas W. Toomey disclosed the sale of 40,000 common shares of the company at a price of $48.6139 per share.
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TGE | Hot Stocks17:17 EDT Tallgrass Energy says 'no change' to 'take private' proposal - There has been no change to the "take private" proposal received by TGE pursuant to the non-binding preliminary proposal letter, dated August 27, from Blackstone Infrastructure Partners, its partners and respective affiliates to acquire all of the outstanding Class A shares representing limited partner interests in TGE not already owned for $19.50 per Class A Share in cash. The proposal continues to be reviewed, evaluated and negotiated by members of an independent conflicts committee. While the committee process is ongoing, TGE plans to only provide business updates, and any further updates to the proposal, on its upcoming quarterly earnings call, unless earlier disclosure is required under applicable law.
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TGE | Hot Stocks17:15 EDT Tallgrass Energy increases quarterly dividend - Tallgrass Energy announced its quarterly dividend for Q3. The dividend will be paid on Thursday, November 14 to shareholders of record as of the close of business on Thursday, October 31. The board of directors of TGE's general partner declared a quarterly cash dividend of 55c per Class A share for Q3, or $2.20 on an annualized basis. This represents a 1.9% sequential increase from the Q2 dividend of 54c per Class A share and an increase of 7.8% from the Q3 2018 dividend of 51c per Class A share.
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WORK | Hot Stocks17:12 EDT Slack Technologies up over 1% after saying it now has 12M DAUs - Shares of Slack Technologies are up 1.2% or 28c to $24.10 in after-hours trading on Thursday.
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TGI | Hot Stocks16:47 EDT Triumph Group sells Nashville structures assembly site to TECT Aerospace - Triumph Group announced a definitive agreement to sell its Nashville based assembly operations to an affiliate of TECT Aerospace. TECT Aerospace manufactures complex aerostructure components, parts and assemblies from the full spectrum of traditional and aerospace alloys, and is headquartered in Wichita, Kansas. The Nashville operations consist of long and large machining, processing and large-scale assembly. It has a workforce of approximately 300 people who support wing skin assembly and machining of stringers and spars. The business generated revenues of approximately $125M during Triumph Group's fiscal year ended March 31, 2019. The transaction is expected to close by calendar year end.
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NWPX | Hot Stocks16:45 EDT Northwest Pipe awarded large steel pipe contract by Oscar Renda Contracting - Northwest Pipe Company was recently selected by Oscar Renda Contracting to supply pipe for Reach 4C through Reach 8 of the Navajo-Gallup Water Supply Project. The Navajo-Gallup Water Supply Project is a multi-phased major infrastructure project underway in northwest New Mexico. The U.S. Bureau of Reclamation in conjunction with the Navajo Nation is constructing the project. Once complete, the project will convey reliable municipal and industrial water supply from the San Juan River to the eastern section of the Navajo Nation, the southwestern portion of the Jicarilla Apache Nation, and the City of Gallup. At build out, the project will encompass 280 miles of pipeline, several pumping plants, and two water treatment plants.
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XONE | Hot Stocks16:45 EDT ExOne trading resumes
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WORK | Hot Stocks16:41 EDT Slack Technologies says it has more than 12M daily active users - Slack Technologies VP & General Manager of Platform, Brian Elliott, wrote in a blog post: "We're seeing a generational shift in how we collaborate at work. People are moving away from email and into channels, away from legacy suites of badly connected products and onto a new customizable platform that can more easily connect the tools they use to work. In September 2019, we exceeded 12 million people actively using Slack every day - up approximately 37% year over year. In addition, with more than 6 million paid seats, the number of engaged and active people who are relying on Slack continues to grow rapidly...DAUs get cited a lot, but what, really, is their significance? In our book, the "U" is what matters: Use! Engagement is what makes Slack work - you can't transform a workplace if people aren't actually using the product. And we love the people building apps and integrations on the Slack platform, because they help drive that engagement." Reference Link
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SABR DAL | Hot Stocks16:36 EDT Sabre extends long-term relationship with Aeromexico - Sabre (SABR) announced that it has extended its long-term relationship with Aeromexico. Aeromexico will continue utilizing Sabre's passenger service system, or PSS, expand its use of the Sabre commercial platform and enhance its utilization of Sabre's global distribution system. Through this technology and distribution expansion, Aeromexico will have the flexibility to support its omni-channel strategies while also delivering customer satisfaction through products. Additional upgraded solutions will allow the airline to improve its personalized offer management, passenger self-service interface and data and analytics reporting. In addition, Sabre will deliver new technologies to enable a customer experience between Aeromexico and its partner Delta (DAL) throughout the traveler journey from passenger recognition to day of departure at the airport. Also, this expansion will allow Aeromexico to reduce costs. Aeromexico and Sabre have partnered since 2011, when the carrier implemented the SabreSonic passenger services system. Additionally, Sabre and Aeromexico have aligned on business initiatives and innovation timelines to support the airline's goals and expectations.
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BURG | Hot Stocks16:35 EDT Chanticleer Holdings Inc trading resumes
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CDE | Hot Stocks16:34 EDT Coeur Mining reports Q3 production of 99,782 ounces of gold - Coeur Mining announced third quarter production of 99,782 ounces of gold, 3M ounces of silver, 4.2M pounds of zinc and 4.5M pounds of lead. Metal sales for the quarter totaled 100,407 ounces of gold, 3M ounces of silver, 4.1M pounds of zinc and 4.3M pounds of lead. The company is reaffirming full-year 2019 production guidance of 334,000 - 372,000 ounces of gold, 12.2M-14.7M ounces of silver, 25M-40M pounds of zinc and 20M-35M pounds of lead.
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POL | Hot Stocks16:33 EDT PolyOne increases quarterly dividend to 20.25c per share - PolyOne has declared a quarterly cash dividend of 20.25c per share on the common stock outstanding. The share will be paid on January 9, 2020 to stockholders of record on December 13, 2019. On an annualized basis, the dividend will increase from 78c to 81c per share on the common stock outstanding.
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EAST | Hot Stocks16:31 EDT Eastside Distilling interim CEO Steve Shum resigns - Eastside Distilling announced the resignation of Steve Shum as the Company's interim Chief Executive Officer, effective immediately, to accept a Chief Executive Officer position with another company. Additionally, Shum submitted his resignation as Chief Financial Officer, effective upon the filing of Eastside's quarterly report on Form 10-Q for the period ended September 30, 2019, expected to be made on or before November 14, 2019. Shum has agreed to consult with the management team and Board of Directors as needed in the future. The company's Board of Directors is running a process to fill the necessary management positions at Eastside with a focus on the Chief Executive Officer role initially. The company is considering both internal and external candidates and will move quickly to fill the position. The company's Board of Directors is committed to enhancing value for shareholders. Working together with its management team, the board has begun a strategic review and evaluation of a number of strategic directives aimed at maximizing shareholder value. The company is reiterating its outlook for the remainder of the year previously issued on August 14, 2019, regarding sales, Redneck Riviera Whiskey case volumes, and Adjusted EBITDA improvements within its related operations. Further, the company remains on track to deliver strong results from its Azunia operations, which were acquired on September 12, 2019.
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VCTR | Hot Stocks16:31 EDT Victory Capital reports AUM $145.8B on September 30
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FPRX | Hot Stocks16:30 EDT Five Prime trading resumes
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ACRS | Hot Stocks16:30 EDT Aclaris Therapeutics trading resumes
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SAVE | Hot Stocks16:26 EDT Spirit Airlines jumps after Q3 TRASM view better than previously anticipated - Shares of Spirit Airlines are up 3% to $34.97 per share in after hours trading after seeing Q3 TRASM better than the company estimated in early September 2019 primarily due to less-than-expected impact on forward bookings related to Hurricane Dorian and higher-than-expected passenger volume.
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WMT | Hot Stocks16:21 EDT Walmart names John Furner President & CEO of Walmart U.S. - Walmart announced that John Furner will become the President and CEO of Walmart U.S., following a successful five years for the business segment under Greg Foran. Furner will report directly to Walmart President and CEO Doug McMillon, and the move will be effective November 1. Foran, who is taking a role as CEO at Air New Zealand Limited, will stay on with Walmart through January 31 to ensure a smooth transition.
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SAVE | Hot Stocks16:20 EDT Spirit Airlines sees Q3 total revenue per ASM or TRASM down 2% YoY - For the third quarter 2019, Spirit estimates its total revenue per ASM or TRASM, will be down about 2% year over year. "This is better than the company estimated in early September 2019 primarily due to less-than-expected impact on forward bookings related to Hurricane Dorian and higher-than-expected passenger volume. Adjusted CASM ex-fuel for the third quarter 2019 is expected to be up about 8.5% year over year, better than the company's most recent guidance largely due to lower crew disruption and passenger re-accommodation expense as a result of better operational performance. Since early September, the company achieved a better-than-expected controllable completion factor, despite higher weather-related cancellations," said Spirit Airlines.
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DOV | Hot Stocks16:19 EDT Dover Fueling Solutions collaborates with ChargePoint over EV charging - Dover Fueling Solutions, a part of Dover that delivers advanced fuel dispensing equipment, electronic systems and payment, fleet systems, automatic tank gauging and wetstock management, is pleased to announce an agreement with ChargePoint to bring electric vehicle chargers to retail and commercial locations in North America. The collaboration will add DC fast chargers, Level 2 AC chargers and fleet chargers to DFS' product portfolio in North America. "As the transition to electric mobility continues to accelerate, partnerships with companies like DFS are key to expanding access to charging and enabling businesses across industries to be part of the build out of the future fueling network," said Scott Miller, Vice President of Global Sales Operations and Channel, ChargePoint. "As a leader in the industry, DFS is well positioned to play a significant role in the shift to electric mobility and we are confident that this collaboration will bring tremendous value to the fueling and convenience retail market in North America."
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JAZZ | Hot Stocks16:19 EDT Jazz Pharmaceuticals commences enrollment in Phase 2 defibrotide trial - Jazz Pharmaceuticals announced that the first patient has been enrolled in an exploratory Phase 2 clinical trial evaluating the ability of defibrotide to prevent neurotoxicity in patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL, receiving CAR T-cell therapy. The prospective, multicenter, open-label, single-arm study will evaluate the safety and efficacy of defibrotide in the prevention of CAR T-cell associated neurotoxicity in patients with relapsed or refractory DLBCL receiving axicabtagene ciloleucel. Patients may experience neurotoxicity after CD19 targeted CAR-T therapy and while the exact cause is unknown, research suggests that endothelial cell damage may play a role. Some researchers hypothesize that the damage caused by cytokine release after CAR-T therapy may compromise the ability of endothelial cells to protect the central nervous system, or CNS, causing neurotoxicity. This study will explore whether defibrotide could help prevent CNS endothelial cell damage, thereby protecting the CNS and minimizing neurotoxicity. This study will be conducted in two parts, with the first part evaluating the safety of a 2.5 mg/kg/dose and a 6.25 mg/kg/dose of defibrotide based on a standard 3+3 design. Part two will evaluate the safety and efficacy of defibrotide at the recommended dose for the prevention of CAR-T-associated neurotoxicity. The primary endpoint is the incidence of CAR-T-associated neurotoxicity by CAR-T Day +30. Approximately 35 eligible patients will be enrolled at six medical centers across the United States.
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APLE | Hot Stocks16:18 EDT Apple Hospitality REIT acquires boutique hotel in Richmond, Virginia - Apple Hospitality REIT announced the acquisition of a 55-room independent boutique hotel in Richmond, Virginia, for a purchase price of approximately $7M, or $125,000 per key.
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AXS | Hot Stocks16:16 EDT Axis Capital sees Q3 pre-tax catastrophe losses $150M-$175M - Axis Capital Holdings Limited announced a preliminary pre-tax loss estimate for Hurricane Dorian, Japanese typhoons and other weather-related events in the range of $150M to $175M, net of estimated recoveries from reinsurance and retrocessional covers, and including the impact of estimated reinstatement premiums. The estimate includes full limit losses from aggregate excess of loss reinsurance treaties that were also impacted by other 2019 catastrophe and weather-related events. The company's loss estimate is consistent with industry insured losses of approximately $6B for Hurricane Dorian and $8B for third quarter Japanese typhoons. The company's loss estimate is based on its ground-up assessment of losses from individual contracts and treaties exposed to the affected regions, including preliminary information from clients, brokers and loss adjusters. Industry insured loss estimates, market share analyses and catastrophe modeling analyses were also taken into account where appropriate. Due to the nature of these events, including the complexity of loss assessment, factors contributing to the losses and the preliminary nature of the information available to prepare this estimate, the actual net ultimate amount of losses for these events may differ materially from this current estimate.
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SIRI | Hot Stocks16:16 EDT Sirius XM increases quarterly dividend 10% - SiriusXM announced that its board declared a quarterly cash dividend of 1.331c per share of common stock, reflecting an increase of 10% over the previous quarter's dividend. This regular quarterly dividend is payable in cash on November 29 to stockholders of record at the close of business on November 8.
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FCPT | Hot Stocks16:13 EDT Four Corners Property Trust acquires Krystal restaurant property for $1.4M - Four Corners Property Trust announced the acquisition of a corporate-operated Krystal restaurant property for $1.4M via a sale and leaseback transaction. The property is located in Tennessee and is occupied under a triple-net lease with a fifteen-year term. The transaction was priced at a capitalization rate consistent with our previous acquisitions of similar restaurants.
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XONE | Hot Stocks16:10 EDT ExOne trading halted, news pending
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BURG | Hot Stocks16:08 EDT Chanticleer Holdings in merger pact with Sonnet BioTherapeutics - Chanticleer Holdings and Sonnet BioTherapeutics a privately-held clinical stage biopharmaceutical company announced they have entered into a definitive merger agreement under which the shareholders of Sonnet will become the majority owners of Chanticleer's outstanding common stock as more fully described below upon the closing of the merger. Subject to shareholder approval by both Chanticleer and Sonnet and approval of the Nasdaq Stock Market, the proposed merger will result in a publicly-traded company operating under the Sonnet name under the proposed Nasdaq ticker symbol "SONN" that will focus on advancing Sonnet's pipeline of oncology candidates and the strategic expansion of Sonnet's technology platform into other human diseases. "This merger is an exciting next step for Sonnet that complements Sonnet's committed financing of up to $100 million and further supports our commitment to advancing our novel oncology product candidates with the ultimate goal of overcoming persistent challenges in cancer care," said Pankaj Mohan, PhD, Founder and Chief Executive Officer of Sonnet. "As we become a publicly-traded entity, we look forward to accelerating the execution of our proprietary platform technology for innovating immune therapeutics that includes our pipeline of clinical and pre-clinical therapeutic candidates." Immediately following the closing of the merger, the former Sonnet shareholders will hold approximately 94% of the outstanding shares of common stock of the combined company and the shareholders of Chanticleer prior to the merger will retain ownership of approximately 6% of the outstanding shares of Chanticleer. In addition, the spin-off entity will receive a five year warrant to purchase approximately 2% of the number of shares issued and outstanding of the Chanticleer at the time of completion of the merger at a purchase price of $0.01 per share. Additionally, terms of the merger include a payment of $6,000,000 to Chanticleer from Sonnet, a portion of which is intended to repay certain of Chanticleer's outstanding indebtedness in conjunction with a spin-off of all of the existing Chanticleer assets and liabilities. The balance of this payment will be retained by the spin-off entity for working capital and general corporate purposes.
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ACRS | Hot Stocks16:05 EDT Aclaris Therapeutics divests Rhofade - Aclaris Therapeutics announced it has divested Rhofade cream, 1% and related intellectual property assets to EPI Health. The divestiture of Rhofade is a key component of Aclaris' recently announced strategic plan to refocus resources on the development of its immuno-inflammatory development programs. Aclaris and EPI Health have entered into a purchase agreement whereby Aclaris sold the worldwide rights to Rhofade, which includes the assignment of certain licenses for related intellectual property assets. Pursuant to the terms of the agreement, EPI Health has agreed to pay Aclaris total cash consideration of up to $55M, consisting of an upfront payment of $35M and potential sales milestone payments of up to $20M in the aggregate upon the achievement of specified levels of net sales of products covered by the agreement. In addition, EPI Health has agreed to pay Aclaris, a specified high single-digit royalty calculated as a percentage of net sales, on a product-by-product and country-by-country basis, subject to specified reductions, limitations and adjustments and 25% of any upfront, license, milestone, maintenance or fixed payment received by EPI Health from a licensee or sublicensee in any territory outside of the United States, subject to specified exceptions. Concurrently with the closing of this transaction, Aclaris repaid in full its $30M term loan with Oxford Finance LLC. As a result of these changes, Aclaris anticipates that its current cash, cash equivalents and marketable securities on hand, including the upfront proceeds received from EPI Health, and the repayment of the outstanding term loan, will be sufficient to fund its operations into Q3 of 2021, without giving effect to any potential new business development transactions or financing activities.
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KIN | Hot Stocks16:04 EDT Kindred Biosciences' Mirataz receives positive opinion from CVMP in the EU - Kindred Biosciences announced that the European Medicines Agency's Committee for Medicinal Products for Veterinary Use has adopted a positive opinion recommending marketing authorization of Mirataz for bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions. Furthermore, KindredBio announced that it recently filed for regulatory approval of Mirataz in Canada. A marketing authorization decision from the European Commission is anticipated within approximately two months. Regulatory approval is subject to the typical risks inherent in such a process. In Canada, the validation of the Canadian submission will be complete in the next 30 to 45 days and once accepted for review, the review timeline is approximately one year. The CVMP's positive opinion is based on results from both clinical and non-clinical studies in which Mirataz resulted in significant weight gain in cats in as little as 14 days following topical application of 2 mg per day. Mirataz was approved by the FDA in May for the management of weight loss in cats.
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HUD | Hot Stocks16:04 EDT Hudson to acquire 34 Brookstone U.S. airport locations - Hudson Group announced it has signed an agreement to acquire assets related to the operation of Brookstone stores in U.S. airports from Apex Digital, Inc. Hudson has also obtained the right to be the exclusive airport retailer to operate Brookstone stores through a license agreement with Bluestar Alliance, LLC, owner of the Brookstone brand and trademarks. The agreement covers 34 airport stores, of which 30 are currently open and operating. Of these 34 stores, 33 stores are in airports where Hudson has existing operations.
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ALXN | Hot Stocks16:04 EDT Alexion appoints Tanisha Carino as chief corporate affairs officer - Alexion announced the appointment of Tanisha Carino as executive VP and the company's first chief corporate affairs officer. Carino will join Alexion on November 4 and will serve on the company's executive committee. In her role, Carino will oversee the creation of a newly integrated corporate affairs function that encompasses Alexion's corporate affairs activities, including relations with domestic and international governments and global communications. Prior to joining Alexion, Carino served as the executive director of FasterCures, a Center of the Milken Institute.
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IMUX | Hot Stocks16:03 EDT Immunic says enrollment complete in Phase 2 EMPhASIS trial of IMU-838 - Immunic announced that the final patient was enrolled and randomized today in the company's phase 2 EMPhASIS trial of IMU-838 for the treatment of relapsing-remitting multiple sclerosis. Patient enrollment was completed well ahead of the original trial schedule. As previously announced, enrollment and randomization of the last patient had been expected during the first half of 2020.
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SYNA | Hot Stocks16:02 EDT Synaptics appoints Dean Butler CFO - Synaptics announced the appointment of Dean Butler as its new CFO, to be effective on October 21. Butler most recently served as VP of Finance at Marvell. Butler also held key financial positions at Broadcom and Maxim Integrated. Effective October 21, Kermit Nolan has resigned his role as interim CFO and will resume his previous role as corporate VP and Chief Accounting Officer.
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FPRX | Hot Stocks16:02 EDT Five Prime announces restructuring, will cut 70 positions - Five Prime Therapeutics, Inc. announced a corporate restructuring to extend the company's cash runway without impacting or delaying the data timelines of its clinical programs. The company will retain a small research group focused on advancing three wholly-owned, late-stage research assets and will increasingly rely on outsourcing and contracted capabilities. The company will eliminate approximately 70 positions across all functions. Seventy percent of these positions will be eliminated by the end of 2019, with the remainder occurring in 2020. The company is also initiating activities to reduce its corporate facilities footprint by either subletting a significant portion of its leased space or subletting the entirety of its building and relocating to smaller facilities. The company believes these actions will improve its potential to bring value to patients, employees and shareholders. The company expects that the restructuring, planned facility expense reduction and other cost-saving efforts will result in approximately $20 million in annualized cost savings, extending the company's cash runway. Five Prime estimates that it will incur approximately $3 million of pre-tax charges for severance and other costs related to the restructuring, primarily in 2019. The company is reaffirming its financial guidance and anticipates ending 2019 with $148 to $153 million in cash, cash equivalents and marketable securities.
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ALK | Hot Stocks16:02 EDT Alaska Air reports combined September traffic up 6.4%, capacity up 3.5% - Load factor increased 2.2 points to 83%.
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BURG | Hot Stocks16:00 EDT Chanticleer Holdings Inc trading halted, news pending
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ACRS | Hot Stocks16:00 EDT Aclaris Therapeutics trading halted, news pending
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FPRX | Hot Stocks16:00 EDT Five Prime trading halted, news pending
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AMZN | Hot Stocks15:38 EDT Amazon announces first Idaho fulfillment center - Amazon announced plans to open its first fulfillment center in Idaho, creating more than 1,000 full-time jobs. The facility will be located in Nampa, Idaho, and will open in 2020.
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EV | Hot Stocks15:03 EDT Eaton Vance raises quarterly dividend 7.1% - The board of Eaton Vance declared a quarterly dividend of 37.5c per share on its common stock. The new quarterly rate represents an increase of 7.1% over the 35c per share declared in each of the company's last four fiscal quarters. The dividend is payable November 15 to shareholders of record on October 31.
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CARG | Hot Stocks14:43 EDT HMI Capital reports 5.68% passive stake in CarGurus - In a regulatory filing, HMI Capital disclosed a 5.68% stake in CarGurus, which represents 5,165,000 shares. The filing does not allow for activism.
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ARPO | Hot Stocks14:33 EDT Aerpio announces trial data for primary open angle glaucoma treatment - Aerpio Pharmaceuticals announced interim results from its Phase 1b clinical trial of a topical ocular formulation of AKB-9778 in development as a potential treatment for primary open angle glaucoma,POAG. "We are encouraged by the early safety findings and potential efficacy signal of this ongoing Phase 1b trial," said Kevin Peters, M.D., Chief Scientific Officer of Aerpio Pharmaceuticals. "The conventional outflow tract is responsible for the majority of fluid drainage from the front of the eye, which is critical for maintaining normal IOP and is often the site of pathology implicated in the increased IOP in patients suffering from POAG. Recent mouse and human genetic data establish a key role for the Tie2 pathway in the development and maintenance of Schlemm's canal, a key component of the conventional outflow tract. AKB-9778, a potent small molecule Tie2 activator, has shown IOP lowering effects after subcutaneous administration in two sequential Phase 2 studies in patients with diabetic retinopathy and normal IOP. We now look forward further to evaluating AKB-9778's safety and activity on IOP in patients with ocular hypertension and POAG."
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OSUR | Hot Stocks13:55 EDT OraSure granted FDA marketing authorization for OraQuick Ebola Test - The U.S. Food and Drug Administration has allowed marketing of a rapid diagnostic test to detect Ebola virus antigens in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola, the agency announced. The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for the Ebola Virus Disease, the agency noted. The FDA granted marketing authorization of the OraQuick Ebola Test to OraSure Technologies.
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BTI... | Hot Stocks13:52 EDT CDC raises estimate of lung injury cases associated with vaping to 1,299 - The CDC announced the updated number of confirmed and probable lung injury cases and deaths associated with e-cigarette product use, or vaping. As of October 8, 2019, 1,299 lung injury cases associated with the use of e-cigarette, or vaping, products have been reported to CDC from 49 states, the District of Columbia, and 1 U.S. territory. Twenty-six deaths have been confirmed in 21 states, the CDC added. The CDC had previously said that as of October 1, 1,080 confirmed and probable lung injury cases associated with e-cigarette product use, or vaping, were reported by 48 states and the U.S. Virgin Islands. The Fly notes that Altria (MO) has a 35% stake in Juul. Other publicly traded companies in the tobacco space include British American Tobacco (BTI), Imperial Brands (IMBBY) and Philip Morris (PM). Reference Link
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PCG | Hot Stocks13:47 EDT PG&E says approximately 600,000 customers still without power
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PCG | Hot Stocks13:47 EDT PG&E says power restored to about 126,000 customers by 6am Thursday - On Thursday morning, October 10, Pacific Gas and Electric Company reported that improving weather conditions in some parts of the areas affected by the Public Safety Power Shutoff have allowed for safety inspections, repairs and restoration in some areas to begin. Approximately 126,000 customers were restored by 6 a.m. Thursday. There are still currently approximately 600,000 customers without power as a result of the PSPS event, which began on early Wednesday. There were no reported fires related to PG&E equipment in the PSPS impact zone. "We faced a choice between hardship or safety, and we chose safety. We deeply apologize for the inconvenience and the hardship, but we stand by the decision because the safety of our customers and communities must come first," said Michael Lewis, Senior Vice President, Electric Operations.
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FSCT... | Hot Stocks13:34 EDT Forescout pummeled, Cisco falls amid weakening enterprise spending view - Shares of publicly-traded companies in the network security space are trading lower after Forescout Technologies (FSCT) announced preliminary results for its third quarter. Forescout slashed its view on sales and profit for the quarter, as sales are seen getting pushed out to future quarters amid a weakening in the global macroeconomic environment. EXPECTATIONS FALL: Forescout now sees total Q3 revenue of $90.6M-$91.6M as compared to its prior view of $98.8M-$101.8M. Non-GAAP operating loss for Q3 is expected to be in the range of $1.6M-$1.4M, compared to the company's prior guidance range for an operating profit of $2.6M-$3.6M. Forescout CEO Michael DeCesare said, "Q3 results were impacted by extended approval cycles which pushed several deals out of the third quarter. This was most pronounced in EMEA against the backdrop of a challenging macro-economic environment. These deals were not lost to competitors and we are working to get them over the finish line." JPMorgan analyst Sterling Auty downgraded ForeScout to Neutral from Overweight after the company announcement. Auty cut his price target for ForeScout shares to $35 from $54. He also called this the "first notable negative preannouncement" in the software sector and thinks investors will be watching carefully to see if there are further issues that will cause multiples in the space to contract further. ENTERPRISE SPENDING DROUGHT: Adding to the negativity in the Enterprise space was a Cisco Systems (CSCO) downgrade from Goldman Sachs. Goldman Sachs analyst Rod Hall downgraded Cisco Systems to Neutral from Buy with a price target of $48, down from $56. Large enterprise spending will continue to weaken and telecom spending activity will remain depressed in the near term, Hall stated. The analyst noted that Goldman's Enterprise Activity Index deteriorated in September, while his latest reseller survey was also incrementally negative on enterprise spending trends. PRICE ACTION: Shares of Forescout are down over 35.5% to $25.26 while Cisco is down over 2%. OTHERS TO WATCH: Other companies to watch in the enterprise and security space include A10 Networks (ATEN), Check Point (CHKP), CyberArk (CYBR), Cyren (CYRN), and Fortinet (FTNT).
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MRK | Hot Stocks13:10 EDT Merck granted orphan status for Keytruda in carcinoma - The FDA granted Merck orphan status for Keytruda as a treatment of biliary tract carcinoma. Reference Link
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INCY | Hot Stocks13:08 EDT Incyte granted orphan status for lymphoma treatment - The FDA granted Incyte orphan status for parsaclisib, its treatment of extranodal marginal zone lymphoma. Reference Link
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EVRG | Hot Stocks13:02 EDT Evergy announces solar energy agreement with The City of West Plains - The City of West Plains, Mo., will partner with Evergy to provide solar power to the community. Evergy will build a new solar array in West Plains that will generate 9.6 megawatts of energy, enough to power 1,200 homes.
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SMIT | Hot Stocks13:00 EDT Schmitt Industries Inc trading resumes
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GKOS | Hot Stocks12:45 EDT Ivantis petition for review of Glaukos patent denied by USPTO - The U.S. Patent and Trademark Office's Patent Trial and Appeal Board announced in a ruling posted to its website that it will not institute an inter partes review as to any of the challenged claims of the '858 patent. Ivantis filed a petition requesting inter partes review of claims 51-54, 56, 57, 60, 61, 63, and 71 of U.S. Patent No. 6,626,858 held by Glaukos. The '858 patent describes shunt devices and a method for continuously decompressing elevated intraocular pressure in eyes affected by glaucoma, the decision noted.
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SMIT | Hot Stocks12:34 EDT Schmitt Industries to sell SBS business line for $10.5M - Schmitt Industries announced that it has entered into a definitive agreement to sell its Schmitt Dynamic Balance Systems, or "SBS," business line to Tosei Engineering Corp. and Tosei America for a purchase price of $10.5M in cash, subject to customary closing adjustments. The transaction, which was approved by Schmitt's board of directors, is expected to close in the fourth quarter of calendar year 2019 following a 30-day go shop period. Michael Zapata, Chairman and CEO of Schmitt, commented, "I'm proud of the Schmitt team and what we've accomplished in a short period of time and I am confident that Tosei is the best strategic partner to maximize the SBS business line's performance to continue supporting SBS customers. Tosei is a market leader in the machine tool market, and the combined entity will feature one of the deepest product portfolios in the grinding industry to go along with SBS's superior quality and service."
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SMIT | Hot Stocks12:26 EDT Schmitt Industries Inc trading halted, news pending
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AMZN AAPL | Hot Stocks12:06 EDT Amazon Music announces availability on Apple TV 4K - Amazon Music (AMZN) announces its new app for Apple TV 4K (AAPL) and Apple TV HD running tvOS 12.0 and later. "Starting today, customers can download the Amazon Music app from the App Store for Apple TV and get access to stream millions of songs and thousands of playlists and stations on Apple TV 4K and Apple TV HD, including access to a wide range of global playlists like Pop Culture, which highlights the most buzzworthy songs across the current pop music landscape, and Rap Rotation, Amazon Music's new home for hip-hop in heavy rotation," the company said in a blog statement. The Amazon Music app for Apple TV is available today to customers in the U.S., U.K., Australia, New Zealand, Brazil, Canada, France, Italy, Spain, Germany, Mexico, Japan, and India. Reference Link
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RYAM | Hot Stocks12:03 EDT Rayonier Advanced Materials up 8% after price hikes on cellulose products - Earlier today, Rayonier Advanced Materials will increase prices of its high-alpha and high-viscosity Cellulose Specialties products, including acetate, ethers, micro-crystalline cellulose, nitrocellulose and other grades) by 6%, effective immediately, or as contracts allow. These price changes are necessary to partially offset ongoing inflationary pressures and sustain investment in its best-in-class, capital-intensive manufacturing capabilities to ensure its ability to continue to support its customers' needs for high-quality products. Shares of Rayonier Advanced Materials are up 8% or 33c to $4.46 in midday trading on Thursday.
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APHA | Hot Stocks12:00 EDT Aphria falls -9.4% - Aphria is down -9.4%, or -50c to $4.89.
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KRA | Hot Stocks12:00 EDT Kraton falls -27.7% - Kraton is down -27.7%, or -$8.33 to $21.74.
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PCG | Hot Stocks12:00 EDT PG&E falls -29.6% - PG&E is down -29.6%, or -$3.25 to $7.73.
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BE | Hot Stocks12:00 EDT Bloom Energy rises 9.1% - Bloom Energy is up 9.1%, or 28c to $3.35.
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DAC | Hot Stocks12:00 EDT Danaos rises 15.2% - Danaos is up 15.2%, or $1.37 to $10.37.
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PUMP | Hot Stocks12:00 EDT ProPetro Holding rises 24.8% - ProPetro Holding is up 24.8%, or $1.96 to $9.86.
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BE | Hot Stocks11:57 EDT Bloom Energy, CalBoio in pact to generate renewable energy from dairy waste - Bloom Energy and California Bioenergy announced a collaboration to deploy the companies' commercial solution for the conversion of dairy waste into renewable electricity without combustion. CalBio's dairy digester technology with Bloom Energy's solid oxide fuel cell technology delivers an end-to-end solution for the capture of methane and generation of renewable electricity. The solution has been designed such that the electricity will power electric vehicles (EVs) throughout California. In integrating these proven technologies, the two companies have created the world's first commercial solution to generate non-combusted electricity from dairy waste to power EVs.
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PBYI | Hot Stocks11:38 EDT Puma Biotechnology falls after Bernie Sanders calls out 20% price hike - Puma Biotechnology (PBYI) increased the price of its breast cancer treatment Nerlynx by 20% in nine months, Ed Silverman of STAT News reported yesterday. Today, Presidential candidate and Senator Bernie Sanders responded to a STAT reporter asking if anybody will notice with a tweet saying, "I noticed, and I'm pretty damn sure patients with breast cancer and their families will notice too." Shares of Puma Biotechnology are down 4.5%, or 35c, to $7.30 in late morning trading. Reference Link
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AAL | Hot Stocks11:35 EDT American Airlines realigns operations and commercial leadership teams - American Airlines announced that Kerry Philipovitch, Senior Vice President of Customer Experience, will retire from the airline at the end of 2019. Philipovitch's retirement is part of a long-planned personal desire to move into a new phase of her life and the airline has been preparing for this day for some time. With this announcement, American is realigning its Operations and Commercial teams around four key pillars of the business: Operations, Network Strategy, Revenue and Customer Experience. The following four leaders will assume responsibility for these teams and each individual will report to Isom: David Seymour, Senior Vice President of Operations, Vasu Raja, Senior Vice President of Network StrategyDon Casey, Senior Vice President of Revenue, Kurt Stache, Senior Vice President of Customer Experience. "This is an opportunity to sharpen our focus on the key parts of our airline: running a reliable operation, expanding the world's best network, maximizing all aspects of revenue to ensure American thrives forever, and delivering a superior customer journey as we create a world-class customer experience," continued Isom. "This restructure puts innovative and extremely capable leaders at the forefront of these initiatives."
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DAL | Hot Stocks10:29 EDT Delta Air Lines says expects to retain market share it picked up this summer
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DAL | Hot Stocks10:21 EDT Delta Air Lines says on track to return approx. $3B to shareholders this year
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DAL | Hot Stocks10:20 EDT Delta Air Lines sees employee costs adding 1 point to 2020 non-fuel CASM
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DAL | Hot Stocks10:10 EDT Delta Air Lines says premium product revenue rose 9% in Q3
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DAL | Hot Stocks10:07 EDT Delta: 'On track' to produce 5th straight year of adj. pre-tax profits above $5B
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DAL | Hot Stocks10:06 EDT Delta Air Lines says expects to achieve 7% topline growth for FY19 - Comments taken from Q3 earnings conference call.
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HUM | Hot Stocks10:04 EDT Humana expands partnership with Accolade with $20M strategic investment - Accolade and Humana announced an expansion of their existing partnership that includes a $20M strategic investment from Humana. The investment comes as Humana affirms its commitment to advance member engagement within its offerings for commercial employer groups, leveraging Accolade to strengthen its consumer-optimized health platform. Humana and Accolade first announced their partnership in March 2019, where both companies agreed to integrate their capabilities to create a differentiated healthcare and benefits experience for individuals and their employers. The companies are expanding their partnership agreement as they continue to create personalized and simplified member experiences and leverage new opportunities around solution flexibility, service delivery, partner integration, and economic value in healthcare. Specifically, the strategic investment will allow the two organizations to tailor the Humana with Accolade solution for a broader base of fully-insured and ASO prospects and clients. The investment will enable robust integrations and seamless engagement options that make it easy for new members to access convenient and affordable care. Humana and Accolade will also significantly expand geographies in 2020 and beyond, while building out the teams needed to support product and market expansion.
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HEXO | Hot Stocks10:00 EDT HEXO Corp falls -18.2% - HEXO Corp is down -18.2%, or -67c to $3.01.
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KRA | Hot Stocks10:00 EDT Kraton falls -21.1% - Kraton is down -21.1%, or -$6.35 to $23.72.
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PCG | Hot Stocks10:00 EDT PG&E falls -29.0% - PG&E is down -29.0%, or -$3.19 to $7.79.
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BKE | Hot Stocks10:00 EDT The Buckle rises 4.5% - The Buckle is up 4.5%, or 85c to $19.95.
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BORR | Hot Stocks10:00 EDT Borr Drilling rises 5.9% - Borr Drilling is up 5.9%, or 31c to $5.59.
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PUMP | Hot Stocks10:00 EDT ProPetro Holding rises 17.2% - ProPetro Holding is up 17.2%, or $1.36 to $9.26.
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WHR | Hot Stocks09:56 EDT Whirlpool announces new head of strategy and business development - Holger Gottstein will join Whirlpool as senior vice president of strategy and business development, as well as the company's executive committee, effective January 1, 2020, the company announced. Gottstein will lead strategy and business planning processes for Whirlpool, including mergers and acquisitions, new business development, and other strategic initiatives. Gottstein joins Whirlpool Corporation from Boston Consulting Group, where he served as managing director & senior partner and has held various leadership roles, Whirlpool said.
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PHG | Hot Stocks09:47 EDT Philips falls -8.9% - Philips is down -8.9%, or -$4.06 to $41.62.
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KRA | Hot Stocks09:47 EDT Kraton falls -21.7% - Kraton is down -21.7%, or -$6.52 to $23.55.
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PCG | Hot Stocks09:47 EDT PG&E falls -25.0% - PG&E is down -25.0%, or -$2.75 to $8.23.
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BORR | Hot Stocks09:47 EDT Borr Drilling rises 5.9% - Borr Drilling is up 5.9%, or 31c to $5.59.
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PSTG | Hot Stocks09:47 EDT Pure Storage rises 6.1% - Pure Storage is up 6.1%, or 99c to $17.35.
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PUMP | Hot Stocks09:47 EDT ProPetro Holding rises 22.3% - ProPetro Holding is up 22.3%, or $1.76 to $9.66.
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MDR | Hot Stocks09:44 EDT McDermott strength attributed to report on progress with lenders - Shares of McDermott International are up 15c, or 9%, to $1.91 in early trading. Contacts tell The Fly that the early strength is being attributed to a report from Debtwire regarding the company making progress toward a deal with its lenders.
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AMRX | Hot Stocks09:40 EDT Amneal Pharmaceuticals announces launch of generic Invega - Amneal Pharmaceuticals announced that it has launched its generic version of Invega extended-release tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg.
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CRTO | Hot Stocks09:28 EDT Criteo partners with Pixalate for ad fraud detection - Criteo announced a global partnership with Pixalate, a cross-platform ad fraud detection and prevention solution. Through this partnership, Pixalate will supplement Criteo's existing IVT detection engine. Pixalate, a service for the detection and filtration of Sophisticated Invalid Traffic across desktop and mobile web, mobile in-app, and over-the-top media/connected TV advertising, will work in tandem with Criteo as an anti-fraud solution, to address General Invalid Traffic and SIVT across Criteo's current suite of products and emerging channels.
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DSX | Hot Stocks09:21 EDT Diana Shipping announces time charter contract for m/v Polymnia - Diana Shipping announced that, through a separate wholly-owned subsidiary, it has entered into a time charter contract with Al Ghurair Resources International L.L.C., Dubai, for one of its Post-Panamax dry bulk vessels, the m/v Polymnia. The gross charter rate is $14,500 per day, minus a 5% commission paid to third parties, for a period of minimum twelve months to about fourteen months. The charter is expected to commence on October 23, 2019. The "Polymnia" is a 98,704 dwt Post-Panamax dry bulk vessel built in 2012. This employment is anticipated to generate approximately $5.22M of gross revenue for the minimum scheduled period of the time charter.
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SSNT | Hot Stocks09:20 EDT SilverSun Technologies board of directors approves $2M stock repurchase program - SilverSun Technologies announced that its Board of Directors has authorized a new stock repurchase program, under which the Company may repurchase up to $2M of its outstanding common stock. Under this new stock repurchase program, SilverSun may repurchase shares in accordance with all applicable securities laws and regulations, including Rule 10b-18 of the Securities Exchange Act of 1934, as amended. The extent to which SilverSun repurchases its shares, and the timing of such repurchases, will depend upon a variety of factors, including market conditions, regulatory requirements and other corporate considerations, as determined by SilverSun's management. The repurchase program may be extended, suspended or discontinued at any time. The Company expects to finance the program from existing cash resources.
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GNBT | Hot Stocks09:19 EDT Generex announces presentation on clinical data of Excellagen - Generex Biotechnology Corporation announced that Lois Chandler, inventor of Excellagen and an advisor to subsidiary, Olaregen Therapeutix, will be presenting the poster entitled "Wound Conforming Matrix Containing Purified Homogenate of Dermal Collagen Promotes Rapid Healing of Diabetic Neuropathic Foot Ulcers: Subset Analysis of Randomized Controlled Trial" during a special poster reception on October 13, 2019, at Caesars Palace, Las Vegas, the official site of the SAWC Meeting. The poster will present clinical data demonstrating significant acceleration of healing rates in patients with chronic diabetic neuropathic foot ulcers following a single application of Olaregen's Excellagen and increased wound closure incidences as compared with Standard of Care.
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HRL | Hot Stocks09:17 EDT Hormel Foods targeting organic net sales growth 2%-3% - Targeting operating profit growth 5%-7%. Sees 15% of net sales from Innovation by 2020. Sees $1B in CapEx planned in the next three years. Comments taken from the company's investor day presentation slides.
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DAL | Hot Stocks09:13 EDT Delta Air Lines reports Q3 traffic up 5.6%, capacity up 3.9%
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AJG | Hot Stocks09:12 EDT Arthur J. Gallagher acquires Florida-based The Doyle Group - Arthur J. Gallagher acquired Ponte Vedra Beach, Florida-based The Doyle Group, and its affiliates, collectively doing business as Direct To PolicyHolder. Terms of the transaction were not disclosed. Founded in 2010, DTPH is an e-commerce affinity platform focused on the efficient acquisition, conversion and retention of professional liability insurance policyholders in the allied healthcare and wellness fields. Nick Doyle and his associates will continue to operate from their current location under the direction of Kevin Garvin, head of Gallagher's North American Affinity operations.
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CLSK | Hot Stocks09:11 EDT CleanSpark appoints Zach Bradford as CEO to succeed Matthew Schultz - CleanSpark announced that as part of its evolving business and drive to profitability, it has implemented a key strategic shift in management and expanded and better aligned its Board of Directors. Matthew Schultz will be moving from his role as CEO to Chairman of the Board and CleanSpark's president and CFO Zach Bradford will assume the CEO position while retaining his title as president. Larry McNeill, the previous Chairman has stepped down from the Chairman role but will remain a key member of the Board. In addition, Bryan Huber a Co-founder who has also served as the Company's COO since 2016 is stepping off the Board to allow for a majority independent Board but will remain with the company as the new CIO. Mr. Anthony Vastola, who has been with the CleanSpark since 2014 and has been the Company's CSO since August, is being appointed as the new COO. Bradford's CFO position is being filled by Lori Love. Love most recently served as the CFO for P2K Labs. In order to increase corporate governance and transition to a majority independent board, the Board appointed two new members, Roger Beynon and Thomas Wood. Beynon most recently worked for his own firm Beynon & Associates.
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AIG | Hot Stocks09:09 EDT AIG appoints John Panagakis as CEO, First Principles Capital Management - AIG has elected John Panagakis as CEO, First Principles Capital Management, the unit of AIG Investments that serves institutional clients across the global fixed income securities and derivatives markets. He will be based in New York and report to Douglas Dachille, Chief Investment Officer of AIG. Panagakis joins FPCM from TIAA Nuveen, where he spent more than 30 years in a variety of asset management, operational and advisory leadership roles, most recently as Executive Vice President, Head of International Advisory Services.
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SGBX | Hot Stocks09:08 EDT SG Blocks partners with CMC Development Group on $15M housing project - SG Blocks announced that it has partnered with CMC Development Group/Creative Container and Spaces/Eco Development on a 100 unit building in Atlanta, known as The Ridge Avenue project - a $15M affordable housing project. Ridge Avenue is the first deal of a new partnership between SG Blocks and CMC, which provides exclusive right of first refusal access to CMC's deals and pipeline, subject to reasonable limits. In exchange for access to CMC's backlog and pipeline projects and recommendation of SG Blocks to other businesses, SG Blocks will provide CMC 50,000 restricted stock units vesting over two years. The Ridge Avenue project is a residential project subject to SG Blocks' recently announced license agreement with CPF MF. As a result, CPF MF will arrange for the design build of the container based modular building for the project and SG Blocks will be entitled to the related fees under the license agreement.
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INFO | Hot Stocks09:07 EDT IHS Markit acquires Novation Analytics, terms not disclosed - IHS Markit announced the acquisition of Novation Analytics, a specialist provider of software solutions, data analysis and advisory services to the automotive industry.
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DOMO SQ | Hot Stocks09:06 EDT Domo announces Domo for Square - Domo (DOMO) announced a new application, Domo for Square (SQ), which empowers merchants that have multiple Square accounts to easily unlock real-time business insights and value from all their Square data. Sellers can easily bring together Square data into one place, making it easier to collect, analyze, and distribute.
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LC | Hot Stocks09:05 EDT LendingClub announces launch of digital loan transaction platform called 'LCX' - LendingClub announced the launch of LCX, a first-of-its-kind electronic marketplace designed to connect a broader array of institutional investors to its new digital platform. LCX delivers dynamic pricing and same day settlement of fully funded whole loans. It continues to unlock the power of the marketplace model by reducing friction in the settlement process, from several weeks to a single day, and allowing faster deployment of capital. The new platform also offers additional real-time insights on demand at the loan level, and provides the initial infrastructure needed for the development of a secondary market that will improve liquidity and value for this mainstream asset class. This combination of speed, access and transparency represents a substantial innovation in consumer loan transaction technology.
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TGEN | Hot Stocks09:04 EDT Tecogen sells chiller to large NYC residential building - Tecogen announced the sale of a 400 ton Tecochill natural gas-fired chiller to a large residential building located in New York City. The unit will provide air conditioning for the building during the cooling months, and the waste heat will be recovered and used to generate domestic hot water for use throughout the building. The Tecochill system replaces an inefficient absorption chiller that required replacement. "Many large residential buildings in New York that heat with steam during the winter months use steam-based absorption chillers for cooling in the summer months," noted Jeff Glick, Vice President of East Coast Sales at Tecogen. "The Tecochill system uses less than one-third of the energy used by typical steam-based absorption systems. Using steam power to drive the absorption process is cost prohibitive compared to the Tecochill natural gas-fired compressor chiller system because of the energy inefficiency of the steam driven process and absorption chilling."
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PEN | Hot Stocks09:03 EDT Penumbra enrolls first patient in CHEETAH study - Penumbra announced enrollment of the first patient into the CHEETAH study, a prospective, multi-center U.S. study to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. Introduced in 2018, as part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
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GRUB | Hot Stocks09:03 EDT Just Salad partners exclusively with Grubhub to launch Health Tribes - Just Salad is exclusively partnering with Grubhub to launch a new virtual restaurant, Health Tribes. The digital-only concept features a variety of diet-specific recipes that will be available exclusively on Grubhub and orderjustsalad.com beginning Thursday, October 10th.
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LRAD | Hot Stocks09:02 EDT LRAD Corporation reports FY19 U.S. law enforcement sales of $1M - LRAD Corporation announced that its U.S. law enforcement sales in fiscal year 2019 were up 93% over fiscal 2018 to a record $1M. The Company's law enforcement sales averaged $683,000 annually over the four previous fiscal years.
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AIG | Hot Stocks09:02 EDT AIG appoints John Panagakis as CEO, First Principles Capital Management - AIG has elected John Panagakis as CEO, First Principles Capital Management, the unit of AIG Investments that serves institutional clients across the global fixed income securities and derivatives markets. He will be based in New York and report to Douglas Dachille, Chief Investment Officer of AIG. Panagakis joins FPCM from TIAA Nuveen, where he spent more than 30 years in a variety of asset management, operational and advisory leadership roles, most recently as Executive Vice President, Head of International Advisory Services.
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POAHY BA | Hot Stocks09:02 EDT Porsche, Boeing sign MOU to explore premium urban air mobility market - Porsche (POAHY) and Boeing (BA) signed a Memorandum of Understanding to explore the premium urban air mobility market and the extension of urban traffic into airspace. With this partnership, both companies will leverage their unique market strengths and insights to study the future of premium personal urban air mobility vehicles. As part of the partnership, the companies will create an international team to address various aspects of urban air mobility, including analysis of the market potential for premium vehicles and possible use cases. Boeing, Porsche and Boeing subsidiary Aurora Flight Sciences are also developing a concept for a fully electric vertical takeoff and landing vehicle. Engineers from both companies, as well as Porsche subsidiaries Porsche Engineering Services GmbH and Studio F.A. Porsche, will implement and test a prototype.
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ONCS | Hot Stocks09:00 EDT OncoSec trading resumes
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DAL... | Hot Stocks08:57 EDT Fly Intel: Pre-market Movers - HIGHER: Ra Pharmaceuticals (RARX), up 102% after entering into a merger agreement pursuant for which UCB will acquire the company for $48 per share in cash... Bed Bath & Beyond (BBBY), up 17% after naming Mark Tritton, formerly of Target (TGT), as its new CEO... Qorvo (QRVO), up 3.5% after Cowen analyst Karl Ackerman upgraded shares to Outperform from Market Perform with a price target of $90, up from $75... Pure Storage (PSTG), up 5% after Goldman Sachs analyst Rod Hall upgraded the stock to Buy from Neutral with a price target of $21, up from $18. DOWN AFTER EARNINGS: Delta Air Lines (DAL), down 4%. LOWER: PG&E (PCG), down 31% after The Wall Street Journal reported Judge Dennis Montail opened the door for a rival chapter 11 plan from Elliott and other bondholders that are allied with victims of wildfires, stripping the company of the sole right to propose a chapter 11 plan covering billions of dollars of damages from fires linked to PG&E equipment... HEXO Corp (HEXO), down 22% after reporting preliminary Q4 revenue and withdrawing FY20 outlook... Village Farms (VFF), down 10% after announcing C$25M bought deal offering of common shares.
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ALTR | Hot Stocks08:57 EDT Altair acquires Polliwog Co., terms not disclosed - Altair announced the acquisition of Polliwog Co. a software company based near Seoul, providing EDA software to the rapidly growing electronics industry. Polliwog expands Altair's solution portfolio for system-level engineering to the PCB design and analysis market. Its impressive customer roster includes major consumer electronics companies, such as Samsung and LG Electronics. The products include a powerful PCB modeler, simulation solvers, and design verification tools, and integrates seamlessly into customer environments that use any of the leading ECAD PCB design solutions.
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AKTX | Hot Stocks08:56 EDT Akari Therapeutics announces Phase II clinical data in bullous pemphigoid - Akari Therapeutics announces that positive data from an ongoing bullous pemphigoid Phase II clinical trial will be presented at the 28th European Academy of Dermatology and Venereology Congress in Madrid, Spain. The presentation will be posted onto Akari's website at Akari Therapeutics. In patients with BP there is evidence that both terminal complement activation and the lipid mediator leukotriene B4 have a central role in driving the disease. Ex vivo data in BP patients, recently published in the August 2019 edition of JCI Insight showed a pronounced accumulation of LTB4 and C5 and its activation products in the inflamed skin of BP disease patients underlying the rationale for treatment with nomacopan which is a bifunctional inhibitor of both C5 and LTB4. The Phase II trial, which includes up to nine mild-to-moderate bullous pemphigoid patients, is a six-week open-label single-arm study evaluating safety and efficacy. Patients entering the trial were typically on the topical steroid mometasone which was stopped by day 21. The main efficacy measure is the Bullous Pemphigoid Disease Area Index which along with blistering is a frequently used evaluation of the extent and severity of this skin disease. Results showed that nomacopan, dosed daily subcutaneously, was well tolerated in six elderly patients, and that there were no reported drug-related serious adverse events. This safety profile mirrors over 20 cumulative patient-years of data from patients treated with nomacopan across four other conditions in clinical development where no drug-related serious adverse events have been observed. Four of the six patients were classified as at the upper limit of moderate BP. Moderate to severe patients represent about two-thirds of BP patients and are likely to benefit most from the potential to reduce or avoid steroids. These patients, who showed only a minor improvement on mometasone prior to initiation on nomacopan, saw a mean 41% and 63% decline in BPDAI score at day 21 and 42, respectively, and a 59% and 68% decline in blister score at day 21 and 42, respectively. One of the moderate patients had a flare up post day-28, which is not an uncommon on treatment as BP is a recurrent autoimmune disease. Of the two mild patients, one patient showed a 100% decline in blisters by Day 21, sustained to day 42, and a decline in BPDAI score of 55% and 45% by day 21 and day 42, respectively. The other patient showed no response either on nomacopan or when switched to rescue steroids at day 28. This patient entered the trial after disease relapse while on steroid treatment. Three of the patients who responded received mometasone steroids tapered to zero by day 21. Two other patients were on nomacopan only, with no steroids, and showed a similar beneficial response with a mean 39% and 79% drop in BPDAI activity at day 21 and day 42, respectively, and a 57% and 93% drop in blisters at day 21 and 42, respectively.
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ZKIN | Hot Stocks08:54 EDT ZK International Group wins $5.8M pipes and fittings supply bid - ZK International's wholly-owned subsidiary Zhejiang Zhengkang Industrial was amongst the five winning bidders to supply stainless steel pipes and fittings for Phase VI of Shenzhen's Community Pipeline Network Upgrade Program managed by Shenzhen Water Group. Twenty enterprises participated in the bidding of the Program that valued at approximately $19.4M. ZK International is expected to supply up to $5.8M worth of its stainless steel pipes and fittings for the Program.
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NEWT | Hot Stocks08:48 EDT Newtek Business Services raises quarterly dividend to 71c per share - Newtek Business Services announced that its Board of Directors declared a fourth quarter 2019 cash dividend of 71.1c per share, which represents a 42.0% increase over the fourth quarter 2018 cash dividend. The fourth quarter 2019 dividend is payable on December 30, 2019 to shareholders of record as of December 16, 2019. With the payment of the fourth quarter 2019 dividend, the Company would be in line with its 2019 annual dividend guidance of $2.15 per share, which would represent a 19.4% increase over the 2018 annual cash dividend of $1.80 per share.
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MYOV | Hot Stocks08:46 EDT Myovant Sciences announces presentation of Phase 3 LIBERTY 1 & 2 results - Myovant Sciences announced that results from its Phase 3 LIBERTY 1 & 2 studies of relugolix combination therapy in women with heavy menstrual bleeding associated with uterine fibroids will be presented in the late-breaking oral session at the 2019 American Society for Reproductive Medicine Scientific Congress, which is being held October 12-16 in Philadelphia, Pennsylvania. Both Phase 3 studies met their primary efficacy endpoint with relugolix combination therapy demonstrating significant reduction in heavy menstrual bleeding in women with uterine fibroids. Key secondary endpoints including a reduction in mean menstrual blood loss volume, achievement of amenorrhea, reduction in pain associated with uterine fibroids, improvement in anemia, reduction in distress from bleeding and pelvic discomfort, and reduction in uterine volume were also met in both studies with statistical significance. The safety profile of relugolix combination therapy in both studies was generally well-tolerated with bone health maintained and vasomotor symptoms comparable to those in the placebo group. In addition, Myovant Sciences will present a poster on the development and validation of the bleeding and pelvic discomfort scale, a patient-reported outcome for women with heavy menstrual bleeding associated with uterine fibroids.
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EGLE | Hot Stocks08:43 EDT Eagle Bulk Shipping takes delivery of M/V Santos Eagle - Eagle Bulk Shipping announced that it has taken delivery of the fourth of six Ultramax drybulk vessels, it has recently agreed to acquire. The ship, which has been renamed the M/V Santos Eagle, is a 2015-built, high specification scrubber-fitted SDARI-64 Ultramax vessel built at Jiangsu New Hantong Ship Heavy Industry Co., Ltd. Proforma for the two remaining acquisition vessels, which have yet to be delivered, the Company's fleet will total 50 ships, including 20 Ultramax drybulk vessels acquired over the last 36 months.
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MXCYY | Hot Stocks08:42 EDT Metso says Finnish Financial Supervisory Authority approves supplement - The Finnish Financial Supervisory Authority has on October 10, 2019, approved a supplement to the Finnish language demerger prospectus relating to the combination of Outotec Oyj and Metso Corporation's Minerals business The supplement relates to the stock exchange releases of Outotec and Metso published on October 8, 2019, regarding the credit ratings assigned to the combined company, Metso Outotec Corporation, resulting from the combination of Outotec and the Metso Minerals Business.
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JAGX | Hot Stocks08:39 EDT Jaguar Health to explore potential license agreements for Mytesi in China - Jaguar Health announced that the company has engaged Angel Pond Capital LLC to explore potential licensing agreements and collaborations for Mytesi in China. Angel Pond was founded by Ted Wang, a former Goldman Sachs partner. "Jaguar has engaged Angel Pond as an advisor to help facilitate and negotiate the out-license of our Mytesi and crofelemer technology in China, including identifying additional potential strategic partners in China beyond those Jaguar has already engaged in discussions and due diligence. Cancer therapy-related diarrhea is our lead potential follow-on indication for Mytesi, and cancer is a leading cause of death in China - making the country a compelling region for addressing the unmet medical need of the devastating diarrhea associated with cancer treatment," Lisa Conte, Jaguar's president and CEO commented. Jaguar's Mytesi product is approved by the U.S. Food and Drug Administration for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Mytesi is the only FDA-approved first-in-class anti-diarrheal drug studied specifically in adults with HIV/AIDS in a chronic therapy setting.
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ONCS MRK | Hot Stocks08:39 EDT OncoSec receives $30M investment in Tavo license by China Grand Pharma - OncoSec entered into a strategic transaction with Grand Decade Developments, a direct, wholly-owned subsidiary of China Grand Pharmaceutical and Healthcare, and its affiliate, Sirtex Medical US. OncoSec will receive a $30M investment from CGP and its affiliate Sirtex at $2.50 per share, an approximate 25% premium to the average share price over the last 20 days since October 9. The transaction is subject to shareholder approval. Upon the closing of this transaction, CGP and Sirtex together will hold 53% of OncoSec common shares and will be entitled to three of nine seats on the OncoSec Board of Directors. Should CGP seek to offer to acquire the remaining shares of OncoSec within the 12 months following the closing of the transaction, the offer price for the outstanding shares of OncoSec must be the greater of $4.50 per share. OncoSec will grant Grand Decade and its affiliates an exclusive license to develop, manufacture, commercialize, or otherwise exploit OncoSec's current and future products in Greater China and 35 other Asian countries. Grand Decade will pay up to 20% royalties on the net sales of such products in the Territory. Sirtex will support and assist OncoSec with pre-marketing activities for TAVO and VLA in exchange for low single-digit royalties on TAVO and VLA net sales outside the Territory. If approved, this transaction will provide OncoSec with funding to complete its two ongoing clinical trials of TAVO in combination with Merck's (MRK) Keytruda. OncoSec anticipates filing for accelerated approval in the U.S. following the completion of its KEYNOTE-695 trial in 2020.
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CPST | Hot Stocks08:38 EDT Capstone Turbine secures DC powered marine microturbine project for superyacht - Capstone Turbine announced that it has secured an order for its first-ever direct drive C65 diesel microturbine generator for marine use after receiving Approval in Principle from Lloyd's Register in Rotterdam on the innovative new design. Seven Turbine Power BV, Capstone's exclusive distributor for Belgium, Denmark, and the Netherlands, helped with the Lloyd's certification process and secured the marine project with a local, high-end shipbuilder. The microturbine is scheduled to be shipped before the end of the year and is set to be commissioned by the summer of 2020.
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MOS | Hot Stocks08:38 EDT Mosaic announces temporary curtailment at Esterhazy mine - Mosaic announced that it will temporarily curtail production at its Esterhazy mine, which when combined with a previously announced potash curtailment, brings total curtailments to up to 600,000 tonnes. The curtailment is not expected to impact the pace of development at the Esterhazy mine K3 project. The increased curtailment is based on increasing inventories as a result of a short-term slowdown in global potash markets and increased risks of a delay in Chinese contract settlement. If the full amount of the curtailment is realized in lower fourth quarter 2019 sales, it would result in a negative impact of approximately $150M in adjusted EBITDA. "While near-term fertilizer markets remain challenging, we continue to expect a very strong application season in Brazil and North America, and a better supply and demand balance in 2020," said President and CEO Joc O'Rourke. The company plans to provide updated market commentary when it reports earnings, after close November 4.
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X | Hot Stocks08:38 EDT U.S. Steel sees Q3 adjusted EPS (26c)-(20c), consensus (33c) - Sees Q3 revenue $3.04B-$3.075B, consensus $3.02B. The company said, "We expect adjusted EBITDA to be in a range of $134M - $144M, which excludes approximately $9M of estimated third quarter impacts from the December 24, 2018 fire at our Clairton coke making facility and approximately $54M of estimated restructuring charges. Stronger shipments and better than expected manufacturing performance in our Flat-rolled segment, as well as a contingency gain from recovered claims arising out of the bankruptcy of a supplier drove better than expected results. "
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FREQ | Hot Stocks08:37 EDT Frequency Therapeutics commences dosing for FX-322 study - Frequency Therapeutics announced that dosing has commenced in a Phase 2a clinical study of FX-322, a locally administered investigational drug candidate designed to regenerate auditory hair cells and restore hearing function. The objectives of the Phase 2a study are to further establish the positive hearing signal observed in Frequency's Phase 1/2 study of FX-322, as well as continue to evaluate safety and define the potential dosing regimen. FX-322 is being developed for the treatment of sensorineural hearing loss, or SNHL, the most common type of hearing loss. The company also announced that the FDA has granted fast track designation for FX-322. At present, there are no FDA-approved medicines for SNHL. In a Phase 1/2 study, FX-322 demonstrated a statistically significant and clinically meaningful improvement in key measures of hearing loss, including clarity of sound and word recognition, with no serious adverse events observed.
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RLMD | Hot Stocks08:36 EDT Relmada Therapeutics commences trading on Nasdaq - Relmada Therapeutics announces that the company's common stock will begin trading on The Nasdaq Capital Market beginning at 9:30 a.m. ET, Thursday October 10, under its existing symbol, "RLMD."
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TROW | Hot Stocks08:35 EDT T. Rowe Price reports preliminary AUM $1.13T at September 30 - Client transfers from mutual funds to other portfolios, including trusts and separate accounts, were $5.3B in September and $7.5B for the quarter-ended September 30. This brings total client transfers for the year-to-date period ended September 30 to $19.5B.
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UTHR | Hot Stocks08:34 EDT United Therapeutics concludes RT234 collaboration with Respira Therapeutics - United Therapeutics has decided to conclude its collaboration with Respira Therapeutics based on a strategic prioritization of assets within United Therapeutics' product development portfolio. Respira, a clinical-stage specialty pharmaceutical company developing next-generation cardiopulmonary disease-targeted inhalation products, has regained full worldwide research, development, and licensing rights to the company's novel inhaled drug-device combination product, RT234. RT234 recently concluded successful Phase 1 clinical studies and is currently in Phase 2 studies for a pulmonary arterial hypertension indication. Respira and United Therapeutics entered into a strategic collaboration in April 2017 for the co-development and exclusive license of RT234 for pulmonary hypertension indications in North America markets. Respira has no further obligation to United Therapeutics regarding the RT234 program, and United Therapeutics has no future development funding obligations. United Therapeutics will retain its minority preferred equity stake in Respira.
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BTAI | Hot Stocks08:34 EDT BioXcel Therapeutics says cash position sufficient to fund data readouts
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BTAI | Hot Stocks08:33 EDT BioXcel Therapeutics expects data readout from Pancreatic Cancer trials in 1H20
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YGYI | Hot Stocks08:33 EDT Youngevity to purchase certain assets of BeneYOU, terms not disclosed - Youngevity and BeneYOU, a nutritional and beauty products company announced that the parties have executed a non-binding Letter of Intent whereby Youngevity International will purchase certain assets of BeneYOU. The parties have acknowledged their plans to execute a definitive Asset Purchase Agreement in the coming weeks with an intention to close the transaction by the end of October.
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BTAI | Hot Stocks08:33 EDT BioXcel Therapeutics expects BXCL701 Phase 1b/2 data readout in Q4
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THO | Hot Stocks08:32 EDT Thor Industries raises quarterly dividend 2.5% to 40c from 39c per share - The regular dividend is payable on November 8 to shareholders of record at the close of business on October 25.
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BTAI | Hot Stocks08:31 EDT BioXcel Therapeutics expects BXCL501 Phase 1b data in 1H20
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BTAI | Hot Stocks08:31 EDT BioXcel Therapeutics expects BXCL501 Phase 3 trial results in 1H20
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BTAI | Hot Stocks08:29 EDT BioXcel Therapeutics affirms expected timeline for upcoming milestones - BioXcel Therapeutics affirmed its expected timeline regarding upcoming milestones. "We believe our recent equity offering represents a key step in driving the success of our clinical programs and providing sufficient funding to support key data readouts, including clinical results from our lead neuroscience program, BXCL501, as well as our immuno-oncology program, BXCL701," commented Vimal Mehta, Ph.D., Chief Executive Officer of BTI.BXCL501, a differentiated, novel agent intended for treatment of agitation in neuropsychiatric diseases, demonstrated statistically significant results in a Phase 1b trial in agitated Schizophrenia patients with clinically meaningful, rapid and durable reduction in agitation. In addition, the results from the Phase 1 trial with IV dexmedetomidine in Alzheimer's Disease patients produced rapid calming effects, as previously announced. "Given there are no FDA approved therapies and that antipsychotics have black-box warnings for elderly patients with dementia, we believe this is an opportune time to continue to advance the clinical development of BXCL501 in geriatric dementia, which has the potential to be a well-tolerated, noninvasive treatment," continued Mehta. "We are further encouraged by the progress we have made in our BXCL701 program, with the first data readout expected from the treatment emergent neuroendocrine prostate cancer program in the fourth quarter of 2019. In addition, we received U.S. Food and Drug Administration Orphan Drug Designation for BXCL701 for the treatment of Acute Myeloid Leukemia, representing a potential expansion of the program into hematological malignancies."
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HTGM QGEN | Hot Stocks08:27 EDT HTG Molecular expects Qiagen agreement to become non-exclusive in oncology - HTG Molecular Diagnostics (HTGM) provided an update regarding its ongoing efforts related to the development, manufacture and commercialization of companion diagnostic assays. In November 2016, HTG entered into a Master Assay Development, Commercialization and Manufacturing Agreement with Qiagen Manchester Limited, a wholly owned subsidiary of QIAGEN (QGEN). This master agreement was exclusive as to both HTG and QML in the field of oncology, and non-exclusive in all other fields. As previously disclosed, HTG expects the master agreement to become non-exclusive in the field of oncology at either HTG's or QML's election commencing November 16, 2019. As a result, HTG expects that: With respect to the two companion diagnostic programs that remain active under the master agreement, HTG will continue to abide by its existing obligations and complete all contracted work. Opportunities for the development of new RNA companion diagnostics that are based on the HTG EdgeSeq technology will be contracted directly by HTG with BioPharma customers. These new companion diagnostic opportunities are expected to leverage the existing HTG-Illumina Diagnostic Development Agreement, which has been in place since 2014 and continues to provide HTG with access to Illumina's diagnostic sequencers and associated sequencing chemistries. In the event that an HTG RNA companion diagnostic program reaches the point where global commercialization is required, HTG will be free to partner with any number of third parties, including possibly QML, with respect to distribution and other commercialization activities.
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ONCS | Hot Stocks08:25 EDT OncoSec trading halted, news pending
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BGFV RRGB | Hot Stocks08:25 EDT Big 5 Sporting appoints Stephen Carley to board of directors - Big 5 Sporting Goods (BGFV) announced the appointment of Stephen Carley to its board of directors. Carley was previously CEO of Red Robin Gourmet Burgers (RRGB).
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FOMX | Hot Stocks08:23 EDT Foamix to present data on topical product candidates for acne, rosacea - Foamix Pharmaceuticals announced it will present results from nine clinical trials in five posters relating to its investigational topical product candidates FMX101 for the treatment of moderate-to-severe acne and FMX103 for the treatment of moderate-to-severe papulopustular rosacea in adults, at the 39th Annual Fall Clinical Dermatology Conference. Poster highlights include: Long-term safety and efficacy data from the open-label extension of two Phase III studies of FMX101 in patients with moderate-to-severe acne for a total treatment period of up to 52 weeks. Data from three 12-week Phase III studies that showed the safety and tolerability of FMX101 in pediatric patients with moderate-to-severe acne. An ex-vivo permeation and penetration assessment in human skin, in which FMX101 and FMX103 delivered similar concentrations of minocycline to the epidermis and sebaceous appendage. These three posters will also be published in an upcoming edition of SKIN, The Journal of Cutaneous Medicine, the official journal of the National Society for Cutaneous Medicine. Foamix will present results of a comparative trial of FMX101 versus five commercially available acne treatments in miscibility with sebum. Additionally, Foamix will present study endpoints achieved with FMX103 in patients with moderate-to-severe papulopustular rosacea in two Phase III 12-week pivotal clinical studies. Foamix previously announced that the U.S. Food & Drug Administration has set an action date of October 20, 2019 under the Prescription Drug User Fee Act for FMX101 for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in adults and pediatric patients nine years of age and older. A New Drug Application for FMX103 for the treatment of moderate-to-severe papulopustular rosacea in adults has also been submitted and is awaiting acceptance by the FDA. The safety and efficacy of FMX101 and FMX103 have not been established and there is no guarantee that they will receive health authority approval or become commercially available.
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MBIO BMY | Hot Stocks08:20 EDT Mustang Bio announces City of Hope receives $4.1M in grant awards - Mustang Bio (MBIO) congratulated City of Hope on its receipt of $4.1M in grant awards for a clinical trial of MB-101 in combination with nivolumab and ipilimumab in patients with recurrent malignant glioma. The trial, which is now enrolling patients, is the first human study to combine IL13Ralpha2 CAR T cells with checkpoint inhibitors, as well as the first to locally deliver CAR T cells with combination treatment with systemic nivolumab treatment. With nivolumab and ipilimumab products provided by Bristol-Myers Squibb (BMY), patients in the randomized Phase 1 trial will receive MB-101 dosed weekly combined with nivolumab, an anti-PD-1 antibody, dosed every other week. Patients on the experimental arm will additionally receive ipilimumab - an anti-CTLA-4 antibody - and nivolumab, each dosed once 14 days prior to the start of combination therapy with MB-101 plus nivolumab. To launch the trial, the National Institutes of Health awarded $3.3M over five years to Behnam Badie, M.D., City of Hope's Heritage Provider Network Professor in Gene Therapy and chief of its Division of Neurosurgery, and Christine Brown, Ph.D., City of Hope's Heritage Provider Network Professor in Immunotherapy and associate director of its T Cell Therapeutics Research Laboratory. Drs. Brown and Badie also received $800,000 from Gateway for Cancer Research.
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TRHC | Hot Stocks08:18 EDT Tabula Rasa HealthCare's SinfoniaRx partners with Drake University - Tabula Rasa HealthCare will deepen its clinical intelligence footprint through subsidiary company SinfoniaRx's strategic partnership with Drake University's College of Pharmacy & Health Sciences. The College, located in Des Moines, Iowa, is a nationally ranked academic program known for leadership and innovation. The partnership will provide community pharmacies additional revenue opportunities through enhanced clinical and telehealth services.
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KTOS | Hot Stocks08:16 EDT Kratos Defense receives initial $2M C5ISR contract award - Kratos Defense & Security Solutions announced that its C5ISR Modular Systems Division has recently received an initial $2M contract award from a national security related customer in support of a large Combat system program. The combat system program that Kratos is now designed in on and supporting is currently expected to ultimately grow and become one of the largest in Kratos' C5ISR business unit. Kratos' C5ISR Modular Systems Division is an industry leader in supporting Command, Control, Communications, Computing, Combat, Intelligence, Surveillance and Reconnaissance Systems. Platforms of Kratos C5ISR include missile, radar, unmanned system, directed energy, missile defense, surface combatant and ground vehicle. Work under this new contract award is expected to be performed in secure Kratos manufacturing facilities. Due to customer related, competitive and other considerations, no additional information will be provided related to this program.
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CHFS | Hot Stocks08:15 EDT CHF Solutions says JAHVH receives final approval for heart failure study - CHF Solutions announced that James A. Haley Veterans' Hospital and Clinics, located in Tampa, Florida, has received Institutional Review Board approval to initiate an outpatient study using the Aquadex FlexFlow systemto assist in the management of fluid overload in patients suffering from heart failure. In July 2018, CHF Solutions had announced that the Department of Veterans Affairs had awarded blanket purchase agreement for up to $6.5M to the Company to supply the ultrafiltration therapy for a period of up to 5 years. This is the first study of its kind to be conducted exclusively through the United States Veterans Administration.
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ENPH | Hot Stocks08:12 EDT Venture Solar leverages Enphase Energy's home energy management products - Enphase Energy announced that Venture Solar is leveraging Enphase home energy management products to expand its service territory into Connecticut and Massachusetts. Venture Solar has optimized the technical and equipment aspects of its residential solar installation business by leveraging the plug-and-play simplicity of the Enphase IQ home energy platform.
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IMMP | Hot Stocks08:10 EDT Immutep receives A$2.5M tax incentive from French government - Immutep announced that it has received a EUR1,568,399, or A$2,546,929, research and development tax incentive payment in cash from the French Government under its Credit d'Impot Recherche scheme. Immutep qualifies to receive CIR tax incentive through its subsidiary Immutep S.A.S. due to the research and development conducted in its laboratory at Chatenay-Malabry in southwestern Paris. The funds will be used to support the ongoing and planned global clinical development of eftilagimod alpha and the preclinical development of IMP761.
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MDRX | Hot Stocks08:09 EDT Allscripts business unit joins Harvard Pilgrim to develop FDA Sentinel System - Veradigm, an Allscripts business unit announced that its Life Sciences business unit joins the Harvard Pilgrim Healthcare Institute and other collaborating partners to continue to develop the FDA Sentinel System, the largest multisite distributed database in the world dedicated to drug safety. The award focuses on two areas: first, managing the Sentinel Operations Center, which builds upon the Institute's 10 years of experience developing and operating the Sentinel System and second, developing a new Sentinel Innovation Center.
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CRNC | Hot Stocks08:09 EDT Cerence partners with Mila - Quebec Artificial Intelligence Institute - Cerence announced it is now a resident partner of Mila - Quebec Artificial Intelligence Institute, an academic institution dedicated to supporting researchers specializing in the field of deep learning. The partnership enables Cerence and Mila to further research and advance cutting-edge work in machine learning and enhance automotive AI applications. As part of the relationship, Cerence researchers will work with Mila interns on projects and contribute to research, publications, and presentations in an AI lab at Mila's Montreal headquarters, just a short distance from Cerence's Montreal office, one of its key global R&D sites with nearly 450 employees.
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SGEN | Hot Stocks08:07 EDT Seattle Genetics initiates Phase 3 clinical trial of tucatinib - Seattle Genetics announced dosing of the first patient in HER2CLIMB-02, a randomized phase 3 clinical trial evaluating investigational agent tucatinib versus placebo, in combination with standard-of-care ado-trastuzumab emtansine, for patients with locally advanced or metastatic HER2-positive breast cancer. This trial is intended to support registration in the U.S. Tucatinib is an oral, small molecule tyrosine kinase inhibitor that is highly selective for HER2.
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TLND MSFT | Hot Stocks08:07 EDT Talend announces availability of Talend Cloud on Microsoft Azure - Talend (TLND) announced Talend Cloud is now available on Microsoft (MSFT) Azure, offering a secure and scalable Integration Platform-as-a-Service for collecting, transforming and cleaning data. With embedded data quality and native integration performance, Talend Cloud on Microsoft Azure delivers the trusted data companies need to make real-time business decisions, accelerate advanced analytics, and meet regulatory compliance requirements.
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ALDR | Hot Stocks08:06 EDT Alder Biopharmaceuticals announces first human dosing in Phase 1 ALD1910 study - Alder BioPharmaceuticals announced dosing of the first patient in a Phase 1 clinical study to evaluate ALD1910 as a preventive treatment for migraine. ALD1910 is an investigational monoclonal antibody that inhibits pituitary adenylate cyclase-activating polypeptide. ALD1910 represents a potential new therapeutic option, focusing on a new pathway in migraine prevention that is distinct from the inhibition of calcitonin gene-related peptide, a neuropeptide believed to play a key role in mediating and initiating migraine attacks. PACAP and its receptors have been found across the pain-processing pathway, and increased levels of PACAP have been found in blood samples of patients experiencing a migraine attack. In preclinical studies, ALD1910 has been shown to be a selective, high-affinity antibody that demonstrated in vivo engagement of the PACAP target. The Phase 1 double-blind, placebo-controlled study of ALD1910 will enroll approximately 100 healthy men and women between the ages of 18 and 55 and will assess the safety, tolerability and pharmacokinetic profile of ALD1910 at various doses. Initial results are expected in the second half of 2020.
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ON | Hot Stocks08:04 EDT Orange France selects wi-fi chipset from ON Semiconductor for Livebox 5 - Quantenna Connectivity Solutions, a division of ON Semiconductor (ON), has announced that Orange France has once again selected ON Semiconductor for its latest gateway, Livebox 5. The new gateway boasts up to 2Gbps speed, making it easy and convenient for all family members to share the connection to enjoy their favorite connected devices and most demanding applications. It also comes with a compact design made of recycled plastics and has an overall carbon footprint lowered by nearly thirty percent compared to the previous generation.
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AMRS AMZN | Hot Stocks08:04 EDT Amyris' Pipette brand launches on Amazon.com - Amyris launched its Pipette brand on Amazon.com. As of October 3, Pipette was available at Pipettebaby.com, buybuyBABY.com, Amazon.com, and Dermstore.com. By month end, Pipette will be available across all brick-and-mortar buybuyBaby stores nationwide and available on Walmart.com by the end of November. Pipette is expected to drive strong top-line sales performance for Amyris in Q4 and beyond. To date, Pipette has received hundreds of consumer reviews with 96% of them rating the brand's products at 4 stars or better. "Through Q3 we have more than doubled product revenue over the same period in 2018. We are on track for about 300% product revenue growth in Q4 over the same period last year," said John Melo, Amyris President and CEO. Continued Melo, "We are delivering on our promise of doubling recurring revenue or better year on year, maintaining our gross margin between 55-65% and significantly reducing our EBITDA losses by as much as half. (...)"
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HEPA | Hot Stocks08:04 EDT Hepion names Dr. Stephen Harrison as Consultant Medical Director - Hepion Pharmaceuticals announced that Stephen Harrison, M.D., has been appointed as Consultant Medical Director. Dr. Harrison is currently a Visiting Professor of Hepatology at the Radcliffe Department of Medicine, University of Oxford. He is also the Medical Director for Pinnacle Clinical Research and the President of Summit Clinical Research.
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ADXS | Hot Stocks08:03 EDT Advaxis, UCLA enter collaboration for glioblastoma immunotherapy research - Advaxis announced a research collaboration agreement with the University of California Los Angeles, or UCLA, to conduct preclinical studies evaluating the company's Lm technology in mouse tumor models of glioblastoma multiforme, or GBM. Specifically, the collaboration with Dr. Vaithi Arumugaswami's group at UCLA's Department of Molecular and Medical Pharmacology will investigate anti-tumor immunity and anti-tumor responses generated by Lm vaccines that express diverse glioblastoma neoantigens.
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BSTC | Hot Stocks08:03 EDT BioSpecifics names Kevin Buchi as CEO - BioSpecifics named life sciences industry veteran Kevin Buchi CEO of BioSpecifics. He will also serve on the company's board of directors. Buchi is currently the chairman of the board of directors at Dicerna Pharmaceuticals and a director of Amneal Pharmaceuticals and Benitec Biopharma Ltd. Buchi was most recently president and CEO at TetraLogic Pharmaceuticals from 2012-2016.
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KRYS | Hot Stocks08:02 EDT Krystal Biotech receives positive EMA opinion on orphan designation for KB105 - Krystal Biotech announced that the European Medicines Agency Committee for Orphan Medicinal Products issued a positive opinion on Krystal's application for orphan designation of KB105, for the treatment of transglutaminase-1 deficient autosomal recessive congenital ichthyosis. KB105 was previously granted orphan drug designation by the United States Food and Drug Administration in August 2018. The positive opinion issued by COMP will be sent to the European Commission which is expected to grant the orphan designation within 30 days.
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LM | Hot Stocks08:01 EDT Legg Mason reports preliminary AUM $781.8B as of September 30 - This month's AUM included long-term net outflows of $1.2B, driven by net outflows of $1.1B in fixed income and $0.6B in equities, partially offset by net inflows of $0.5B in alternatives. AUM also included net liquidity inflows of $3.7B, partially offset by negative foreign exchange of $0.4B.
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MITO | Hot Stocks08:00 EDT Stealth BioTherapeutics Corporation (ADS) trading resumes
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KRA | Hot Stocks07:52 EDT Kraton lowers 2019 adjusted EBITDA view 10%-15% from previous $370M-$390M view - Expects Q3 Adjusted EBITDA $80M and Q3 net income $21M. Continued deterioration in market demand in China and Asia associated with ongoing trade tensions and the impact of tariffs, as well as weakening demand in Europe, particularly for automotive and compounding applications, impacted sales of HSBC product grades for the company's Polymer segment during Q3. In addition, results for the Polymer segment were affected by soft paving and roofing demand, reflecting elevated customer inventories following a weak Q2 and ample supply availability from market participants, which contributed to intensified competitive market conditions.
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MEDIF | Hot Stocks07:50 EDT Medipharm Labs closes $38.7M upsized credit facility - MediPharm Labs announced its wholly-owned subsidiary, MediPharm Labs Inc. has closed a credit agreement with a top 5 Canadian Schedule 1 bank for an aggregate $38.7M. The Credit Facility was upsized from the previously announced committed term sheet of $20M, and is comprised of a revolving term facility, a non-revolving term facility and a non-revolving delayed draw term facility. The Company's $38.7M Credit Facility was upsized from the previously announced committed term sheet of $20M. The revolving term facility is for up to $25M subject to the Company's borrowing base, can be drawn in Canadian or Australian dollars, has a 1-year term and is to be used for Canadian and Australian working capital. The $5.7 million non-revolving term facility was fully drawn on closing, has a 3-year term and was used to refinance and reduce the interest expense of an existing mortgage. The non-revolving delayed draw term facility of up to $8M has a 3-year term and is to be used to fund capital expenditures. The Credit Facility will bear interest at the Bank's prime lending rate plus a certain per cent per annum dependent upon the Company's debt to EBITDA ratio. The Credit Facility has a first ranking general security interest in the Company's assets and can be repaid without penalty.
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THERF THTX | Hot Stocks07:48 EDT Theratechnologies begins trading on Nasdaq Capital Market - Theratechnologies announced that its common shares will begin trading on the NASDAQ Capital Market under the symbol "THTX". The Company will maintain its common share listing on the Toronto Stock Exchange under the symbol "TH".
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ENLV | Hot Stocks07:45 EDT Enlivex Therapeutics announces presentation of Allocetra-OTS preclinical data - Enlivex Therapeutics announced that the European and Int'l Shock Societies selected, for an oral presentation, "Pathogen- and damage-associated molecular patterns are immune modified by apoptotic cell adjuvant therapy for acute sepsis in a cecal ligation and puncture mice model, and avoids multi-organ failure and improves survival" to be presented at the XVIIIth Congress of the European Shock Society and IXth Congress of the Int'l Federation of Shock Societies. The presentation details results of preclinical studies, which were designed to evaluate the effect of Allocetra-OTS immunotherapy on subjects with highly-severe sepsis. The data showed ten-fold increased survival for study subjects who were treated with Allocetra-OTS therapy and antibiotics and fluids, as compared to subjects treated solely with antibiotics and fluids. Specifically, the levels of cytokine storms and organ failures were dramatically lower in the Allocetra-OTS group, leading to improved survival. ALLOCETRA by Enlivex was designed to provide a novel immunotherapy mechanism of action that targets life-threatening clinical indications that are defined as "unmet medical needs", including prevention or treatment of complications associated with bone marrow transplantations and/or hematopoietic stem cell transplantations; organ dysfunction and acute multiple organ failure associated with sepsis; and enablement of an effective treatment of solid tumors via immune checkpoint rebalancing.
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AZRX HEPA | Hot Stocks07:42 EDT AzurRx BioPharma appoints James Sapirstein as president, CEO - AzurRx BioPharma (AZRX) announced that James Sapirstein has been appointed to serve as the Company's president and CEO following the resignation of Thijs Spoor from the same positions. Sapirstein most recently served as CEO and board member for ContraVir Pharmaceuticals, now known as Hepion Pharmaceuticals (HEPA). Spoor will remain on AzurRx's Board of Directors.
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ALXN MITO | Hot Stocks07:41 EDT Alexion, Stealth BioTherapeutics to co-develop, commercialize elamipretide - Alexion Pharmaceuticals (ALXN) and Stealth BioTherapeutics (MITO) announced an agreement for an option to co-develop and commercialize elamipretide for mitochondrial diseases. Currently being evaluated in a Phase 3 study in people with primary mitochondrial myopathy, or PMM, - a genetic mitochondrial disease - elamipretide is a novel, potential first-in-class therapy that targets mitochondrial dysfunction. There are currently no therapies approved to treat PMM, which is characterized by debilitating skeletal muscle weakness, chronic fatigue and exercise intolerance. Under the terms of the agreement, Alexion will have the opportunity to exercise the option following the delivery of results from the Phase 3 study currently underway in PMM.
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FOLD | Hot Stocks07:39 EDT Amicus sees 'clear path' to projected $500M+ Galafold revenue in 2023 - Amicus Therapeutics announced preliminary unaudited revenue for the third quarter of 2019 in advance of its Analyst Day. Analyst Day will highlight the financial strength and outlook of the Company in addition to recent progress and updates related to its early- and late-stage rare disease portfolio, including a late-stage biologic AT-GAA with breakthrough therapy designation for Pompe disease, a clinical-stage intrathecal AAV gene therapy with positive interim results in CLN6 Batten disease, and a robust gene therapy pipeline. Amicus Analyst Day 2019 The company said, "Key Takeaway: Galafold continues strong launch performance and cornerstone of Amicus success with 1,000+ net global Galafold patients treated and clear path to projected $500M+ in 2023 and $1B+ peak revenue. Financial outlook strengthened with current cash now revised to well into 1H 2022 through major portfolio milestones and global growth. AT-GAA for Pompe advances toward approval as "crown jewel" of Amicus portfolio with peak revenue potential of $1B-$2B, with exclusivity well into 2030s.Portfolio of gene therapy programs and technologies provides foundation for future, including two clinical-stage programs, a Pompe gene therapy clinical candidate declared to move into IND-enabling studies, and eight additional preclinical gene therapies"
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TW | Hot Stocks07:38 EDT Tradeweb Markets reports September ADV up 47.3% y/y to $872B - Tradeweb Markets reported a new record for average daily volume, or ADV, of $872B in aggregate for the month of September, representing an increase of 47.3% year over year.
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FOLD | Hot Stocks07:36 EDT Amicus says cash runway projection extends into 1H22 - The company said, "Following a diligent review of current and outer year operating and capital expense projections, and robust outlook for Galafold revenue, Amicus now expects to end 2019 with more than $420M in cash on hand and has extended the cash runway projection from 2021 to well into the first half of 2022. "
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ALNY | Hot Stocks07:35 EDT Alnylam files marketing authorization application for patisiran in Brazil - Alnylam announced that the marketing authorization application of patisiran for the treatment of patients with hereditary transthyretin-mediated, or hATTR, amyloidosis with polyneuropathy has been filed with the Brazilian Health Regulatory Agency,or ANVISA. Patisiran has been granted priority review by ANVISA. Alnylam expects a decision from ANVISA in the first half of 2020. Patisiran, which will be commercialized following regulatory approval under the brand name Onpattro, is Alnylam's first investigational drug submitted for review in Brazil. If approved, it will be the first product to be launched and marketed by Alnylam in the country and the first ever RNAi therapeutic to be approved in Latin America.
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MITO | Hot Stocks07:27 EDT Stealth BioTherapeutics Corporation (ADS) trading halted, news pending
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CPE CRZO | Hot Stocks07:11 EDT Callon Petroleum files definitive proxy statement for merger with Carrizo Oil & Gas - Callon Petroleum (CPE) has filed definitive proxy materials with the SEC in connection with the company's pending all-stock acquisition of Carrizo Oil & Gas (CRZO). Callon will commence mailing the joint proxy statement / prospectus to its shareholders on or about October 11. The Callon Special Meeting of Shareholders to vote on the transaction is scheduled for November 14. All shareholders of record of Callon common stock as of the close of business on October 7 will be entitled to vote. Highlights of the transaction include: Callon will have an approximate 200,000 net acre footprint in the Permian Basin and Eagle Ford Shale, including over 90,000 net acres in the Delaware Basin, and approximately 2,500 total gross horizontal drilling locations. Callon expects this combination to be immediately accretive to EPS, CFPS and FCFPS, debt adjusted growth per share and net asset value per share. The company also expects $100M of incremental free cash flow in 2020, and double that in 2021. The combination is expected to generate synergies of $850M in net present value, delivering over $2 per share of value to Callon shareholders. The company expects to achieve annual run-rate operational synergies of $65M-$85M driven by Delaware drilling and completion cost savings and improved Permian production uptime, as well as cash G&A savings of $35M-$45M per year. Callon has established a target of $300M-$400M of additional monetization proceeds for the combined company by year-end 2020. The board of Directors of the combined company will consist of 11 members, including Callon's eight current board members and three individuals from the Carrizo Board.
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VLRX | Hot Stocks07:09 EDT Valeritas announces presentation of preclinical h-Patch cannabidiol study - Valeritas Holdings announced a poster presentation at the American Epilepsy Society's Annual Meeting. On July 30th, Valeritas announced results from a preclinical pharmacokinetic study of cannabidiol subcutaneous infusion with two dosing regimens delivered via its proprietary h-Patch wearable drug delivery device. The company believes this study represents the first report of CBD delivered via subcutaneous infusion in any preclinical model. Valeritas' h-Patch is a drug delivery technology that can facilitate the subcutaneous delivery of injectable medicines to patients across a broad range of therapeutic areas. The company's V-Go is an FDA-cleared product that utilizes the h-Patch technology. To date, more than 20M V-Go insulin delivery devices have been sold in the United States.
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CGC STZ | Hot Stocks07:08 EDT Canopy Growth names David Klein as Chair of Board of Directors - Canopy Growth (CGC) is pleased to announce that David Klein has been appointed Chair of its Board of Directors, effective immediately. Klein currently serves as the Executive Vice President and CFO of Constellation Brands (STZ).
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RADA | Hot Stocks07:07 EDT RADA Electronic announces $6M in new orders - RADA Electronic Industries announced that it has received $6M in new orders during August and September of 2019. Over 90% of the new orders are for RADA's multi-mission, software-defined tactical radar systems. Applications for the radar systems are mainly for C-UAV solutions, and for V-SHORAD and APS solutions.
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CSIQ | Hot Stocks07:06 EDT Canadian Solar awarded 393.7 MWp in solar power projects in Brazil - Canadian Solar has been awarded three solar photovoltaic projects totaling 393.7 MWp in two recent Private Corporate Auctions held in Brazil in Q3. Canadian Solar will develop and build two projects, one in the State of Pernambuco - 190.5 MWp - and the other in the State of Ceara - 76.2 MWp. Construction is expected to start in 2021, and the projects will reach commercial operation before the end of 2022. Most of the energy generated will be purchased by COPEL Energia under two 15-year Power Purchase Agreements. In addition, the company will develop and build a 127 MWp project in the State of Minas Gerais, expected to reach commercial operation before January 2023. Canadian Solar now has over 2 GWp of awarded and contracted PPAs in Latin America.
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DAL | Hot Stocks07:06 EDT Delta Air Lines CEO says 'demand for the Delta product remains healthy' - "Our powerful brand and competitive strengths drove another quarter of great results for our people, customers and owners. Our people bring our brand to life on every flight and I'm pleased to recognize their outstanding efforts with over $1 billion in profit sharing accrued so far this year," said Ed Bastian, Delta's CEO. "Demand for the Delta product remains healthy, positioning the company for a strong close to 2019 with expectations for more than 20% earnings growth, over $4 billion in free cash flow and a 5th year of pre-tax earnings over $5 billion."
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DAL | Hot Stocks07:06 EDT Delta Air Lines reports Q3 CASM-Ex up 2.4% - Total unit revenue, adjusted, increased 2.5%; Total unit revenue and total unit revenue adjusted increases were driven by healthy leisure and corporate demand and an approximate one point benefit from the amended American Express agreement. Consolidated operating cost per available seat mile decreased 2.1% compared to the September 2018 quarter, primarily due to lower fuel costs and higher capacity. Non-fuel unit cost increased 2.4% compared to the prior year period, driven by employee costs, record passenger volumes and weather.
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PLUG | Hot Stocks07:05 EDT Plug Power, WSU partner to implement cryogenic hydrogen cooling technology - Plug Power showcases a partnership with Washington State University's Hydrogen Properties for Energy Research Labs to develop cryogenic hydrogen cooling technology to focus on one of the logistical issues of delivering hydrogen at scale: efficient storage and transfer. The proposed sub-cooling solution will enable improvements to the transportation and storage of liquid hydrogen to fueling stations. It will allow Plug Power's fleet vehicle customers, including material handling lift truck fleets, to achieve lower fuel costs due to lower back-end costs of transportation and storage. In the future, this innovation will improve the operational efficiency of GenFuel liquid hydrogen architecture, which is critical for the high-volume hydrogen fueling needed to support the burgeoning on-road fuel cell electric vehicle market. Plug Power and WSU's project comes in three phases. The project is currently in its first phase, during which the teams must advance the fundamental understanding of the technology at cryogenic temperatures. WSU is uniquely positioned to conduct this research due to the university's cryogenic hydrogen lab. The next phase will also take place at the lab, where analytical modeling will be developed and validated to ensure the design is optimized for Plug Power's cryogenic hydrogen applications. Finally, a field test will take place on full scale Plug Power hydrogen storage systems to validate operational performance improvements.
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JBLU | Hot Stocks07:05 EDT JetBlue reports September traffic up 3.4% - JetBlue reported its preliminary traffic results for September. Traffic in September increased 3.4% from September 2018, on a capacity increase of 2.5%. Load factor for September was 80.3%, an increase of 0.6 points from September 2018. JetBlue's preliminary completion factor for September was 97.9% and its on-time performance was 82%. Q3 revenue per available seat mile is expected to decrease approximately 0.9% year-over-year. This is consistent with its revised guidance range of down 2% to flat.
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BR | Hot Stocks07:04 EDT Broadridge acquires Fi360 - Broadridge has entered into a purchase agreement to acquire Fi360, a provider of fiduciary-focused software, data and analytics for financial advisors and intermediaries across the retirement and wealth ecosystem. Fi360 also provides the accreditation and continuing education for the Accredited Investment Fiduciary Designation, the leading designation focused on fiduciary responsibility. Fi360 supports industry needs through analytical and reporting software that helps investment professionals document investment processes and evaluate products. The acquisition is expected to close in November. Terms of the transaction were not disclosed.
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GKOS | Hot Stocks07:03 EDT Glaukos completes patient enrollment in U.S. IDE trial for iStent infinite - Glaukos announced the completion of patient enrollment in its FDA Investigational Device Exemption, or IDE, trial for the iStent infinite Trabecular Micro-Bypass System. In the trial, 72 subjects were implanted with the iStent infinite at 15 separate clinical sites. All surgeons performing the iStent infinite procedures were board-certified glaucoma specialists. The trial's primary effectiveness endpoint is a 20% or greater reduction in mean diurnal IOP from baseline at 12 months postoperative on the same or fewer topical ocular hypotensive medications. Glaukos plans to use the trial results as the basis for seeking FDA approval of the iStent infinite.
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DAL | Hot Stocks07:03 EDT Delta Air Lines sees Q4 TRASM, adjusted up 0%-2% y/y - Sees Q4 CASM -ex up 4%-5% y/y; Sees Q4 system capacity up ~4.5% y/y; Pre-tax margin 9.5%-11.5%; fuel price $2.00-$2.20.
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PRNB | Hot Stocks07:02 EDT Principia Biopharma announces preliminary data of PRN1008 from Phase 2 trial - Principia Biopharma announced preliminary data from its Phase 2 pemphigus, open-label, trial. Among all 15 patients in Part B of the Phase 2 trial, six patients have reached a complete response thus far, with four patients remaining on treatment who have the potential to still reach CR. There were five patients who were unable to achieve a CR. To date, nine of the 15 patients enrolled in Part B have achieved a PDAI score of 1 or 0. The primary efficacy endpoint results have been similar in Part A and Part B. In Part B, a starting dose of 400mg once daily was tested and it was determined to be less effective. At the recommendation of the Safety Monitoring Committee, all patients were escalated to twice daily dosing. Regarding safety, the preliminary data are consistent with Part A and no additional serious adverse events have been reported at doses up to 600mg twice daily. Additional data from this trial will be submitted for presentation at an upcoming medical conference and, with the last patient enrolled in June, Principia anticipates providing a further update by the end of the year. Principia earlier this year announced positive Phase 2 Part A trial data that included 27 patients with pemphigus in an open-label trial to evaluate PRN1008's potential to induce rapid onset of clinical response, enable tapering and/or avoidance of corticosteroids use, and lower autoantibody levels. In Part A, the observed CR rate was 25 percent for those patients who had been on therapy for 12 weeks. Principia is currently enrolling patients in a global, randomized, double-blind, placebo-controlled, pivotal, Phase 3 clinical trial, the PEGASUS study, in approximately 120 patients to evaluate PRN1008 versus placebo, using a background treatment of tapering doses of corticosteroids. The trial entry criteria include patients with moderate to severe pemphigus who are either newly diagnosed or relapsing with chronic disease. This demographic will potentially represent three quarters of the pemphigus patient population. The primary efficacy endpoint is the ability of PRN1008 to achieve durable complete remission on very low-dose CS after 36 weeks of treatment. Durable complete remission is defined as a state in which all lesions have healed, and no new lesions have appeared for a period of at least eight weeks. Key secondary endpoints include cumulative CS use and time to complete remission. After 36 weeks, all patients will be treated with active PRN1008 therapy in an open-label extension period of 24 weeks. PRN1008 has been granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of patients with PV and by the European Commission for treatment of patients with pemphigus.
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CATO | Hot Stocks07:02 EDT Cato Corp. reports September SSS up 5% - Cato Corporation reported sales for September 2019 of $70.5M, up 2% compared to sales of $69.4M for September 2018. Same-store sales in September were up 5% compared to September 2018. CEO John Cato stated, "September same-store sales benefited from the negative impact of Hurricane Florence last year. September tariffs have been implemented, and we remain cautiously optimistic as we evaluate the impact of these and future tariffs." As of October 5, 2019, the company operated 1,299 stores in 31 states, compared to 1,350 stores in 33 states as of October 6, 2018.
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MD | Hot Stocks06:53 EDT Mednax signs agreement to sell MedData business to Frazier Healthcare - Mednax and Frazier Healthcare Partners have entered into a definitive agreement under which Mednax will sell its MedData business to Frazier. MedData is a provider of technology-enabled management services for hospitals, health systems and healthcare providers. Mednax will receive cash consideration of approximately $250M at closing, as well as economic consideration of up to $50M contingent on short and long-term performance of MedData. The company classified MedData as discontinued operations beginning in Q1. Mednax also anticipates certain cash tax benefits from the transaction in the coming quarters. Mednax expects to use net proceeds from the sale for debt repayment, share repurchases and strategic acquisitions.
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BKE | Hot Stocks06:52 EDT The Buckle reports September net sales up 2.5% to $77.3M, SSS up 3% - The Buckle announced that comparable store net sales, for stores open at least one year, for the 5-week period ended October 5, increased 3% from comparable store net sales for the 5-week period ended October 6, 2018. Net sales for the 5-week fiscal month ended October 5, increased 2.5% to $77.3M from net sales of $75.4M for the prior year 5-week fiscal month ended October 6, 2018. Comparable store net sales year-to-date for the 35-week period ended October 5, increased 1% from comparable store net sales for the 35-week period ended October 6, 2018. Net sales for the 35-week fiscal period ended October 5, increased 0.5% to $559.6M from net sales of $556.6M for the prior year 35-week fiscal period ended October 6, 2018.
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RETA ABBV | Hot Stocks06:48 EDT Reata Pharmaceuticals reacquires developing and marketing rights from AbbVie - Reata Pharmaceuticals (RETA) has reacquired development, manufacturing and commercialization rights concerning its proprietary Nrf2 activator product platform originally licensed to AbbVie (ABBV) for territories outside of the U.S. nited with respect to bardoxolone methyl and worldwide with respect to omaveloxolone and other next-generation Nrf2 activators. Reata now possesses exclusive, worldwide rights to develop, manufacture and commercialize bardoxolone methyl, omaveloxolone, and all other next-generation Nrf2 activators, excluding certain Asian markets for bardoxolone. As consideration, AbbVie will receive a total of $330M in cash, primarily for rights to bardoxolone. Reata will make an upfront payment of $75M in 2019, with the remainder payable in installments in 2Q20 and 4Q21. In addition, AbbVie will receive low single-digit, tiered royalties from worldwide sales of omaveloxolone and certain next-generation Nrf2 activators, and no royalties on bardoxolone. Reata has also entered into an amendment to its loan and security agreement with Oxford Finance and Silicon Valley Bank. The amended agreement makes $75M available to Reata upon positive, topline, registrational data from either the CARDINAL study of bardoxolone methyl in patients with Alport syndrome or the MOXIe study of omaveloxolone in patients with Friedreich's ataxia. Overall, the term loan facility increased by $30M to $155M.
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LAZ | Hot Stocks06:47 EDT Lazard reports preliminary AUM approximately $230.9B as of September 30 - The month's AUM included market appreciation of $4.5B; foreign exchange depreciation of $0.5B and net outflows of $1.9B.
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WDR | Hot Stocks06:46 EDT Waddell & Reed reports preliminary AUM $68.8B as of September 30 - Compared to $69.6B on August 31.
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EBS | Hot Stocks06:39 EDT Emergent BioSolutions' chikungunya vaccine receives EMA prime designation - Emergent BioSolutions' chikungunya virus virus-like particle vaccine candidate, CHIKV VLP, was granted PRIority MEdicines, or PRIME, designation by the Committee for Medicinal Products for Human Use of the European Medicines Agency during its September meeting. The PRIME scheme is designed to enhance support for the development of medicines that target an unmet medical need and that may offer a major therapeutic advantage over existing treatments, or benefit patients without preventative or treatment options. The development plan contemplates initiation of a pivotal trial in 2020. The CHIKV VLP vaccine candidate is licensed from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. It received Fast Track designation from the FDA in May 2018.
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NGD | Hot Stocks06:36 EDT New Gold reports total Q3 production 128,899 gold equivalent ounces - Reports Q3 gold production 91,087 ounces, 168,159 ounces of silver and 20.1 million pounds of copper. 2019 total production guidance is 465K-520K gold equivalent ounces. The Rainy River Mine reported Q3 gold equivalent production of 76,092 ounces. Production is on track to meet annual guidance of between 250,000 to 275,000 gold equivalent ounces. The New Afton Mine delivered Q3 gold equivalent production of 52,807 ounces, 16,007 ounces of gold and 20.1 million pounds of copper. Production is on track to meet guidance of between 215,000 to 245,000 gold equivalent ounces.
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MMS | Hot Stocks06:31 EDT Maximus raises quarterly dividend 12% to 28c from 25c per share - The dividend is payable on November 29 to shareholders of record on November 15. On an annual basis, this brings the company's cash dividend to $1.12.
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GM | Hot Stocks06:23 EDT General Motors reports Q3 China vehicle sales down 17.5% to 689,531 - General Motors' joint ventures delivered 689,531 vehicles in China in the third quarter, a 17.5% y/y decline. Sales declined in the midst of the continued soft vehicle market. GM is in the process of introducing a record of about 20 new and refreshed models in China this year with an expanded and improved product mix. GM has increased its focus on midsize/large SUVs and luxury vehicles to keep up with strong demand in these segments by launching seven new models in the past three months and unveiling three models that are planned for launch in the fourth quarter.
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FLR | Hot Stocks06:19 EDT Fluor Joint Venture completes pipe spool fabrication work for Kuwait project - Fluor's joint venture COOEC-Fluor Heavy Industries fabrication yard in Zhuhai, China, has completed the pipe spool fabrication portion of its scope of work in support of the Kuwait Integrated Petroleum Industries Al-Zour project in Kuwait. COOEC-Fluor delivered more than 95,000 pipe spools by fabricating 337,000 linear meters of carbon, alloy and stainless steel pipe. The fabricated pipe spools were delivered to a Fluor-led joint venture that is currently working to deliver two engineering, procurement, fabrication and construction packages for key process support units, utilities and infrastructure for the Al-Zour refinery project in Kuwait. Upon completion, the new complex is expected to be one of the largest refineries in the world and produce 615,000 barrels of oil per day.
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TGT BBBY | Hot Stocks06:18 EDT Target announces resignation of Chief Merchant Mark Tritton - Target (TGT) yesterday announced the resignation of its chief merchant Mark Tritton. With this departure, Christina Hennington and Jill Sando will assume interim leadership of the retailer's merchandising organization. In January 2019, Target named both Hennington and Sando senior vice presidents and general merchandising managers, reflecting their expanded responsibilities with the company. During this interim period, Hennington and Sando will report directly to CEO Brian Cornell. This operating structure will remain in place until further notice, and the company does not plan to initiate an external search at this time. The Fly notes that Tritton was named president and CEO of Bed Bath & Beyond (BBBY) on Wednesday.
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PUMP | Hot Stocks06:11 EDT ProPetro board elects Anthony Best as lead independent director - In light of Gobe's appointment as Executive Chairman, the independent directors of the Board elected Anthony Best to serve as lead independent director of the Board on October 3, 2019. The lead independent director's authority, responsibilities and duties are detailed in the company's Corporate Governance Guidelines, and include: presiding over all meetings of the Board at which the Chairman of the Board is not present, including any executive sessions of the independent directors; approving Board meeting schedules and agendas; and acting as the liaison between the independent directors and the CEO and Chairman of the Board.
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PUMP | Hot Stocks06:10 EDT ProPetro: Additional time to be required to file Form 10-Q - As previously disclosed, due to the Audit Committee's review, the company has not filed its quarterly report on Form 10-Q for the quarter ended June 30, 2019 with the SEC. Although fact finding associated with the Audit Committee's review has been substantially completed, additional time will be required for new members of the company's management team who are responsible for certifying the accuracy of the company's financial information and the effectiveness of the company's disclosure controls and procedures to be in a position to so certify. Management will also require additional time to evaluate the impact of any identified material weaknesses on the company's prior filings. The company's conclusions regarding any material weaknesses could result in a requirement to amend prior SEC filings. In addition, the company's independent registered public accounting firm will require additional time in order to evaluate the internal review and associated findings, as well as the company's proposed remediation plan and the impact that any identified material weaknesses may have on its prior opinions.
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PUMP | Hot Stocks06:09 EDT ProPetro says likely to conclude 'one more more material weaknesses'
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PUMP | Hot Stocks06:09 EDT ProPetro announces substantial completion of fact finding for internal review - ProPetro yesterday announced a number of changes to its Executive Leadership Team in connection with the substantial completion by the Audit Committee of fact finding associated with its previously disclosed internal review. Fact-Finding Key Items: Substantially completed fact finding for previously disclosed internal review. The Audit Committee and management have not identified to date any items that would require restatement of the Company's previously reported balance sheets, statements of operations, statements of shareholders' equity or statements of cash flows. Announced new management appointments along with improved organizational structure to strengthen internal controls. The company is continuing to review one or more related party transactions. The related party transactions currently under review involve real estate transactions and do not involve any of the company's current or former customers or vendors. The Audit Committee and management have not identified to date any items that would require restatement of the Company's previously reported balance sheets, statements of operations, statements of shareholders' equity or statements of cash flows. However, the Audit Committee's internal review has identified a number of internal control deficiencies. As a result of these internal control deficiencies, the company's management is likely to conclude that there were one or more material weaknesses that resulted in the company's internal control over financial reporting and disclosure controls and procedures not being effective as of a prior date. To address the internal and disclosure control deficiencies noted above, the Board and management have implemented certain, and are continuing to evaluate and expect to implement a number of additional, remedial measures. Since the Original Form 8-K, the company has formed a Disclosure Committee, appointed Trey Wilson as the company's Chief Disclosure Officer, and revised and expanded key Company policies to enhance its internal and disclosure control environment. The company is also adopting enhanced documentation and revising key accounting policies and procedures with an emphasis on transactions involving related parties or potential conflicts of interest and travel and entertainment and expense reimbursement. Although significant work has been completed and a number of control deficiencies are in the process of being remediated, management has not yet completed its evaluation of certain internal control deficiencies identified as a result of the internal review, but it is likely to conclude that there were one or more material weaknesses that resulted in the company's disclosure controls and procedures not being effective. The company expects to include additional information with respect to any identified material weaknesses in future filings with the SEC.
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PRQR | Hot Stocks06:08 EDT ProQR Therapeutics' sepofarsen shows vision improvement in Phase 1/2 results - ProQR Therapeutics announced 'positive' top-line results from the PQ-110-001 study, a Phase 1/2 dose range finding, first-in-human trial of sepofarsen in patients with Leber's congenital amaurosis 10 due to the p.Cys998X mutation in the CEP290 gene. "We reported today that patients receiving sepofarsen had a clinically meaningful improvement in vision, and in some cases the patient's vision improved to a level that could be deemed life changing (...)" said Stephen Russell, Principal Investigator at the University of Iowa. "LCA10 is a severe inherited retinal disease that leads to blindness, and for which there is currently no treatment." David Rodman, ProQR's Executive VP of R&D, said, "(...) The top-line data from this study strengthen our confidence in the design of the ongoing Phase 2/3 trial, which could be the sole registration trial for the sepofarsen program (...) " Top-line data is expected in the first half of 2021. The 12-month top-line results from the Phase 1/2 trial confirm durable activity of sepofarsen for up to one year in patients with LCA10. Results also support assumptions . The target registration dose was associated with a clinically meaningful and statistically significant improvement in vision and had a favorable benefit/risk profile, a six-month dosing frequency, as used in Illuminate, was associated with durable improvements in vision, the response observed at 12 months in the target registration dose was equal to or greater than the response at the 3-month interim analysis, and the study population were more likely to respond to treatment with sepofarsen. Sepofarsen was observed to be well-tolerated with manageable safety findings.
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CTVA | Hot Stocks06:05 EDT Corteva CTO Neal Gutterson to retire in 2020 - Corteva announced that Neal Gutterson, senior VP and CTO, has indicated his intent to retire from the company in the second half of 2020. Gutterson remains committed to Corteva and to leading the R&D organization until his successor is selected and for a period after to assure a smooth transition. The company has engaged an executive recruitment firm to identify a replacement. Gutterson joined DuPont Pioneer in 2014 as the VP of Ag Biotech R&D and assumed his current global role in 2016 prior to Corteva Agriscience's spin-off from DowDuPont.
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RARX | Hot Stocks06:01 EDT UCB acquires RA Pharmaceuticals for $48 per share in cash or $2.1B - UCB and Ra Pharmaceuticals (RARX) announced their entry into a merger agreement pursuant for which UCB will acquire Ra Pharma. Under the terms of the agreement, Ra Pharma shareholders will receive $48 in cash for each Ra Pharma share at closing. The boards of both companies have unanimously approved the transaction, which remains subject to approval by Ra Pharma shareholders and to obtaining antitrust clearance. Upon closing, Ra Pharma shareholders will receive $48 for each Ra Pharma share, which represents a transaction value of approximately $2.1B, net of Ra Pharma cash. The cash consideration represents an approximately 93% premium to Ra Pharma shareholders based on the 30-day volume weighted average closing stock price of Ra Pharma prior to signing. UCB and Ra Pharma expect to complete the transaction by the end of Q1 2020. The acquisition will not impact UCB's 2019 financial guidance. Jean-Christophe Tellier, CEO UCB said: "Ra Pharma is an excellent strategic fit addressing multiple areas of UCB's patient value growth strategy. Upon closing, the acquisition will add to our strong internal growth opportunities - six potential product launches in the next five years, strengthening our neurology and immunology franchises with late and early-state pipeline projects. In addition, the combination will provide us with the opportunity to become a leader in treating people living with myasthenia gravis, an auto-antibody mediated neurological orphan disease with high unmet medical need, as well as adding a highly productive technology platform to our innovation engine."
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PM | Hot Stocks05:23 EDT Philip Morris sets carbon neutrality target for all factories by 2030 - Philip Morris announced its aim that all its factories become carbon neutral by 2030. The announcement comes as PMI celebrates its factory in Klaipeda, Lithuania, as its first carbon neutral manufacturing facility.
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HCM | Hot Stocks05:22 EDT Chi-Med, Innovent expand global collaboration - Innovent Biologics and Hutchison China MediTech, or Chi-Med, announced the expansion of their global collaboration agreement to evaluate the safety and efficacy of Innovent's Tyvy, a fully human anti-programmed cell death protein 1 monoclonal antibody, in combination with Chi-Med's surufatinib, a novel inhibitor of vascular endothelial growth factor receptor, or VEGFR, fibroblast growth factor receptor 1, or FGFR1, and colony stimulating factor-1 receptor in patients with advanced solid tumors. The expansion builds on the existing global collaboration agreement between the two companies on sintilimab in combination with Chi-Med's highly selective VEGFR inhibitor, fruquintinib.The expansion of the global collaboration will allow Innovent and Chi-Med to jointly explore the potential application of Tyvyt and surufatinib combination therapy in solid tumors with global unmet medical needs. Clinical studies with this new combination will be conducted both in the United States and in China. The combination of Tyvyt and surufatinib is expected to have synergistic anti-tumor effects by simultaneously targeting multiple cell types and signaling pathways in the tumor microenvironment. Preclinical studies have suggested that surufatinib is able to inhibit angiogenesis, block the accumulation of tumor associated macrophages and promote infiltration of effector T cells into tumors, all of which could contribute to improve anti-tumor activity of Tyvy.
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