Stockwinners Market Radar for December 11, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
NCR | Hot Stocks20:34 EST NCR enters consent decree to resolve claims related to Kalamazoo River matter - NCR Corporation announces the resolution of the Michigan Kalamazoo River environmental cleanup and related Superfund litigation by entering in to a definitive consent decree with the United States Government and the State of Michigan, under which the company expects to conclude the longstanding matter. The decree is subject to court approval. Upon approval by the court, the decree will bring to an end a set of complex litigations that commenced in 2010. In particular the settlement will provide contribution protection to NCR that will foreclose Superfund litigation claims brought against it by the other companies that themselves had contributed to the pollution of the river. The cleanup work is expected to be performed over the next 20 years. NCR will seek significant contribution from NCR's indemnitors as it has in the past for other projects.
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RH | Hot Stocks19:27 EST RH CEO sold 500,000 common shares of company from Dec 9 through Dec 11 - RH announced that Chairman & Chief Executive Officer Gary Friedman sold an aggregate of 500,000 shares of RH common stock from December 9, 2019 through December 11, 2019 consisting of an option to purchase 100,000 shares, and 400,000 shares of common stock that Friedman owned outright. Friedman reported that the current sale of shares was made in order to fund a final payment obligation due under a marital dissolution agreement; the acquisition and improvement of real estate for a personal residence; and the repayment of outstanding balances under personal line of credit borrowings. The current sale represented approximately 6.9% of Friedman's aggregate ownership stake in RH. Following this sale, Friedman retains beneficial ownership of 6,730,158 shares, representing beneficial ownership of approximately 28.1% of RH's common stock. Friedman has also informed the company that he does not expect to sell additional shares at this time.
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CRWD | Hot Stocks19:17 EST Crowdstrike CFO sells 215K shares of common stock - In a regulatory filing, Crowdstrike disclosed that its CFO Burt Podbere sold 215K shares of common stock on December 9th. The total transaction size was $10.7M.
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GLD | Hot Stocks19:00 EST SPDR Gold Shares holdings rise to 886.22MT from 885.93MT - This is the first increase since November 25th.
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DLHC... | Hot Stocks18:57 EST Fly Intel: After Hours Movers - UP AFTER EARNINGS: DLH Holdings (DLHC) up 4.8%. ALSO HIGHER: FormFactor (FORM) up 13.7% after raising Q4 guidance. DOWN AFTER EARNINGS: Lululemon (LULU) down 4.2%... Quanex (NX) down 6.8%... Tailored Brands (TLRD) down 3.5%... Nordson (NDSN) down 1.8%... Mesa Air (MESA) down 1.2%... Oxford Industries (OXM) down 1.2%. ALSO LOWER: Akoutsis (AKTS) down 6.7% after equity offering. Movers as of 18:45ET.
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TTD | Hot Stocks18:57 EST Trade Desk CEO: We don't own any media - In an interview on CNBC's Mad Money, Trade Desk CEO Jeff Green said: We're an objective player because we don't own any media... We are a play on the open internet... We have to respect privacy, but also show relevant ads... Our partnerships in China have been really strong this year.
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RACE | Hot Stocks18:45 EST Ferrari enters into new EUR 350M credit facility - Ferrari announces that it has signed a EUR350M unsecured committed revolving credit facility, or New RCF, intended for general corporate and working capital purposes. The New RCF, entered into with a group of twelve banks, has a five-year tenor with two further one-year extension options, exercisable on the first and second anniversary of the signing date on Ferrari's request and on each bank's approval for its participation. This facility replaces the EUR500M committed revolving credit facility due November 2020, which has been cancelled. The New RCF provides a lower cost of capital as compared to the prior facility and confirms the support that Ferrari receives from a large panel of international key relashionship banks. Its lower size reflects an overall evaluation of the optimal capital structure of the company going forward.
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VMW... | Hot Stocks18:42 EST VMware's Poonen: Our networking business is on fire - In an interview on CNBC's Mad Money, VMware (VMW) COO, customer operations Sanjay Poonen said: We are the Tesla (TSLA) of networking... Everything we do is for the long term... We're going to become the indispensable nervous system for companies... Two key words customers are talking about are migration and modernization...Our partnership with Dell (DELL) is better than ever... Our business in China is growing.
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SMTC | Hot Stocks18:38 EST Semtech director sells 19.3K shares of common stock - In a regulatory filing, Semtech disclosed that its director Charles Ammann sold 19.3K shares of common stock on December 11th. The total transaction size was $910K.
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PANW | Hot Stocks18:22 EST Palo Alto Networks CEO: No systematic problem with our sales - In an interview on CNBC's Mad Money, Palo Alto Networks CEO Nikesh Arora said: What we've done in the past 18 months has exceeded my expectations... I could not be happier with the progress we've made with our products... Wall Street is too focused on short term outcomes... We have raised our guidance for our next-generation products... Firewalls are not dead... We are not a consumer internet business.
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PBYI | Hot Stocks18:08 EST Puma Biotechnology presents Phase II results of neratinib in breast cancer - Puma Biotechnology announced that results from an ongoing Phase II clinical trial of Puma's drug neratinib are being presented at the 2019 San Antonio Breast Cancer Symposium. Neratinib was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the U.S. as Nerlynx tablets. Nerlynx was granted marketing authorization by the European Commission for the extended adjuvant treatment of hormone receptor-positive HER2-positive early stage breast cancer in August 2018. The Phase II SUMMIT basket trial is a study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating HER2 or HER3 mutations. The interim efficacy summary of the breast cohort that received neratinib in combination with trastuzumab and fulvestrant showed that for the 17 efficacy evaluable patients, 9 patients - 53% - experienced a confirmed objective response, all of which were classified as partial responses, and 10 patients - 59% - experienced clinical benefit. The median duration of response has not been reached and the median progression-free survival was 9.8 months. At the time of data cut-off, five patients continued to receive treatment. The most frequently observed adverse event was diarrhea. No patient permanently discontinued neratinib due to diarrhea.
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GTHX | Hot Stocks18:05 EST G1 Therapeutics presents data from Phase 1b/2a trial of lerociclib at SABCS - G1 Therapeutics reported additional data from the Phase 1b/2a clinical trial investigating its oral CDK4/6 inhibitor lerociclib in combination with fulvestrant for the treatment of estrogen receptor-positive, HER2-negative breast cancer. Updated findings presented during a poster session at the 2019 San Antonio Breast Cancer Symposium, or SABCS, showed lerociclib, dosed without a drug holiday, has a differentiated safety and tolerability profile than observed in clinical trials with currently marketed CDK4/6 inhibitors. Preliminary efficacy findings were consistent with other CDK4/6 inhibitors used in combination with fulvestrant. The Phase 1b/2a trial is designed to evaluate the safety, tolerability and efficacy of lerociclib administered continuously in combination with fulvestrant as a treatment for ER+, HER2- breast cancer and identify the dose and schedule for future trials of lerociclib. Further investigation is ongoing, with longer-duration efficacy data required to determine the dose for future study in a Phase 3 clinical trial. The company expects to share an update in 2020.
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NH | Hot Stocks18:01 EST NantHealth presents new breast cancer research findings at SABCS - NantHealth announced new breast cancer research findings presented during a poster session at the San Antonio Breast Cancer Symposium. The Symposium, held at the Henry B. Gonzalez Convention Center in San Antonio, TX from December 10-14, provides state-of-the-art information on the experimental biology, etiology, prevention, diagnosis and therapy of breast cancer and premalignant breast disease, to an international audience of academic and private physicians and researchers. NantHealth's presentation examined how results of the phase 3 KATHERINE clinical trial, first presented at SABCS 2018 and simultaneously published in the New England Journal of Medicine, affected treatment patterns and regimen selections among general medical oncologists in the U.S. before and after the results were publicly released. Data from NantHealth's Eviti Connect, an evidence-based treatment intelligence and web-based oncology decision support platform, was analyzed to determine the rate of requests for treatment authorization for adjuvant Ado-trastuzumab emtansine in patients with HER2-positive early-stage breast cancer. Study results indicated an immediate increase in T-DM1 use in the months following SABCS 2018. Based on data pulled from Eviti Connect, 95 cases would have received adjuvant T-DM1 in Q1 2019 after 0 in Q4 2018. When comparing T-DM1 and Trastuzumab use in the adjuvant breast cancer setting for HER2-positive patients, T-DM1 use since December 2018 increased and Trastuzumab use decreased as a percentage of treatment plan requests for adjuvant HER2-positive patients. "Our research clearly shows that presenting clinical data at a leading conference like the San Antonio Breast Cancer Symposium, and having the data simultaneously published in a medical journal, influences a broad audience of oncologists," said Sandeep "Bobby" Reddy, MD, Chief Medical Officer, NantHealth. "As results indicate an immediate increase in T-DM1 use in the months following SABCS 2018, leveraging multiple communications platforms is an important and effective way to relay practice-changing clinical data to practicing oncologists in the U.S. These forums and supporting scientific journals expose researchers, academics and medical professionals to the latest studies and ideas in the field for which they can apply to their practice."
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TWTR AAPL | Hot Stocks17:51 EST Twitter announces support for iOS Live Photos that will show as GIFs - Earlier today Twitter (TWTR) said that users can upload Live Photos from Apple's (AAPL) iPhone or iPad and they will show as GIFs on the social media platform. Twitter tweeted earlier:"Give the gift of GIFs. You can now upload your iOS Live Photos as GIFs anywhere you upload photos on Twitter." Reference Link
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GVA | Hot Stocks17:46 EST Granite Construction awarded $14M site development project in Illinois - Granite's wholly-owned subsidiary, Kenny Construction, has been awarded a $14M contract by Fermi Research Alliance for Long-Baseline Neutrino Facility Near Site Conventional Facilities Site Preparation Project at the Fermi National Accelerator Laboratory in Batavia, Illinois. The LBNF Near Site will be home for a portion of the international Deep Underground Neutrino Experiment, an international flagship science project hosted by the U.S. Department of Energy's Fermilab. Kenny is responsible for the site preparation construction to clear the proposed LBNF near the site of conflicting facilities. Construction began in December 2019 and will be complete by early 2021.
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FCAU | Hot Stocks17:34 EST UAW ratifies CBA with Fiat Chrysler - UAW Fiat Chrysler U.S. members ratified the 2019 Collective Bargaining Agreement by overall 71%, the UAW announced. The pattern agreement provides a pathway for temporary and full-time workers to top pay; creates parity on full-time worker health care; adds coverage for prescription drug costs for temporary workers; includes a signing bonus and wages that are consistent with pattern; and adds $4.5B in new investment in addition to the previously announced $4.5B investment that includes a new Detroit plant, the union said. The ratified contract also includes an economic package of a $9,000 per full-time member signing bonus, performance bonuses, two 3% annual raises and two 4% lump-sum payments and holds the line on out-of-pocket health care costs.
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LMPX | Hot Stocks17:23 EST LMP Automotive Chairman Samer Tawfik buys over $1.7M in company shares - LMP Automotive Chairman Samer Tawfik disclosed in a regulatory filing that he had purchased 131,646 shares of company stock at an average price of $13.15 per share on December 10 and December 11. The total transaction value of the purchase was $1,731,119.
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CEI | Hot Stocks17:05 EST Camber Energy responds to unusual market activity - Camber Energy commented that it is aware of the recent unusually high trading volume and increase in share price of its common stock since December 9 on the NYSE American. Camber confirms that although it is customarily involved in ongoing discussions with multiple parties regarding potential transactions, it is not currently aware of any material undisclosed information which is binding on the company, that may be contributing to the recent increase in trading volume and increase in market price. The ompany has no further updates to provide at this date. The company stated that it has provided, and will continue to provide, complete disclosure and updates with respect to any material events affecting its business, as they occur.
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AGI | Hot Stocks17:03 EST Alamos Gold sees FY20 production 425K-465K ounces of gold - Alamos Gold provided 2020 production and operating guidance. "Alamos remains on track to achieve 2019 production and cost guidance driven by a strong year from both of our Canadian operations. Young-Davidson is having a solid year operationally while making excellent progress on the construction of the lower mine expansion. Island Gold has already established another record for annual production and free cash flow, and with the ongoing exploration success we expect a further increase in both mineral reserves and resources with our year end update," said John A. McCluskey, President and Chief Executive Officer. Gold production is on track to be within the guidance range of 480,000 to 520,000 ounces. Similarly, total cash costs and all-in sustaining costs are expected to be consistent with guidance. The company sees 2020 production guidance of 425,000-465,000 ounces of gold, down from 2019 reflecting the previously guided lower production from Young-Davidson during the first half of 2020 while completing the tie-in of the upper and lower mines, as well as the end of production from El Chanate. The company sees total cash cost guidance of $770-$810 per ounces and all-in sustaining cost guidance of $1,020-$1,060 per ounces. Sees FY20 capital budget $180M-$205M. Sees 50% increase in dividend starting in the first quarter of 2020. Sees FY21 production increasing to approximately 500,000 ounces per year from existing operating mines.
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XOM | Hot Stocks16:59 EST Exxon Mobil's Milton sells 13,569 common shares - In a regulatory filing, Exxon Mobil vice president Bryan W. Milton disclosed the sale of 13,569 common shares of the company at a price of $69.4377 per share on December 10.
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MMNFF | Hot Stocks16:54 EST MedMen granted delivery-only license by the city of Mountain View, California - On November 21, the company was granted a delivery-only license by the city of Mountain View, California, which granted three delivery-only licenses in total. Mountain View is one of the largest suburbs in California's Bay Area and is home to several leading technology companies. The Mountain View delivery depot will serve as the Company's hub for serving the cities in the surrounding areas, which include Palo Alto, Menlo Park and Los Altos. Illinois: On December 2, the company closed on its acquisition of PharmaCann's Evanston, Illinois location pursuant to the Termination and Release Agreement dated October 7, entered into between the Company, PharmaCann, LLC and the other parties thereto. On December 5, 2019, the company announced that MedMen Red, one of MedMen's in-house lines of cannabis products, was made available in Nevada. MedMen Red flower and pre-rolls are available exclusively at MedMen's Paradise, Downtown Las Vegas and Spring Valley locations. Florida: The Company currently operates eight locations across the state of Florida and expects to open one more location in the heart of South Beach Miami in early calendar 2020.
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EQH | Hot Stocks16:53 EST AXA Equitable sells two run-off and closed-block companies - AXA Equitable has entered into a definitive agreement to sell U.S. Financial Life Insurance Company and MONY Life Insurance Company of the Americas to Heritage Life Insurance. The transaction is expected to close in early 2020. USFL and MLICA were acquired concurrent with the company's acquisition of the MONY Group in 2004 and have been in run-off since 2007. The businesses have combined net statutory reserves of approximately $1.0B. Total consideration to AXA Equitable Holdings was not disclosed and is subject to changes in financial condition prior to closing.
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MMNFF | Hot Stocks16:50 EST MedMen announces financial updates to strengthen balance sheet - MedMen Enterprises announced several financial arrangements and corporate updates that will strengthen the company's balance sheet and enhance overall corporate governance. Updates include: 1) the execution of financial agreements, which includes US$37M in financing; 2) an amendment to certain of the company's outstanding debt; 3) an expansion of the company's corporate SG&A initiatives through a new round of cost reductions; and 4) enhanced corporate governance with the company's co-founder Andrew Modlin granting a limited proxy to Ben Rose, Executive Chairman of the Board with respect to Mr. Modlin's Class A Super Voting Shares for a period of one year. "Today's announcements are a clear indicator of our ability to execute on capital allocation and cost saving initiatives to position MedMen for improved, long-term growth," said Adam Bierman, MedMen Co-founder and Chief Executive Officer. "Our long-term investors have shown confidence in our strategic direction and industry-leading retail brand. With this strong level of support, we can now further focus management's attention on maximizing our core assets while also reducing our corporate expenses to achieve positive EBITDA in calendar year 2020."
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ECA | Hot Stocks16:42 EST Encana to establish corporate domicile in U.S. - Encana filed its definitive Proxy Statement/Prospectus with the U.S. Securities and Exchange Commission and Canadian securities regulatory authorities related to its intention to establish corporate domicile in the United States. The Special Meeting of Security holders is planned for January 14, 2020 at 8 a.m. MT. Encana shareholders and incentive award holders as of the close of business on December 9, 2019 will be entitled to notice of and vote at the meeting. The single reorganization resolution, as further outlined in the definitive Proxy Statement/Prospectus, must be approved by at least two-thirds of votes cast. The resolution will accomplish three initiatives: To establish the Company's corporate domicile in the U.S. The migration to the U.S. from Canada is expected to expose the Company to increasingly larger pools of investment in U.S. index funds and passively managed accounts. Today, the majority of Encana's assets, people and production are in the U.S. The migration to the U.S. from Canada will better align our business operations with the corporate domicile, as well as our U.S.-based peers. Additional details can be found in the definitive Proxy Statement/Prospectus.
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WHLR | Hot Stocks16:38 EST Wheeler REIT nominees recommended by Glass Lewis - Wheeler REIT announced that proxy advisory firm Glass Lewis has issued its recommendation for shareholders to vote for the company's nominees. Excerpts from the report include: "(...) while there remain substantial challenges for the Trust, we believe the board has already been favorably augmented and is overseeing a sound restructuring program at this time. Upon review, we believe Stilwell has presented Wheeler investors little more than a fractionally updated iteration of its failed 2018 campaign, offering a substantially similar candidate slate and an alternative operating strategy which represents an improvement over the Dissident's previously vacant plan only as a simple matter of default (...) the pronounced gravity of the implied ethical concern demands unambiguous transparency toward other Wheeler investors. In this regard, we consider Mr. Stilwell's existing response -- which makes no effort to address the issue in direct terms or refute any of the now widely reported claims -- appears to fall fundamentally short of candor. (...) in the absence of further public disclosure on the matter, we believe this issue works against what we already consider to be a weak case by the Dissident."
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NDSN | Hot Stocks16:35 EST Nordson says backlog for the quarter was approximately $385M, down 1% YoY - Backlog for the quarter ended October 31 was approximately $385 million, a decrease of 1 percent compared to the same period a year ago. Impact from the fiscal 2019 acquisition of Optical Control GmbH was not significant. Backlog amounts are calculated at October 31, 2019 exchange rates.
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GAIN CPTA | Hot Stocks16:35 EST Gladstone Investment exits investment in Nth Degree - Gladstone Investment (GAIN) has sold its portfolio company Nth Degree to MSouth Equity Partners, an Atlanta-based private equity firm. As a result of this transaction, Gladstone Investment realized a significant capital gain on its equity investment and retained a minority equity investment in Nth Degree. Gladstone Investment acquired Nth Degree in partnership with Capitala Finance (CPTA) and Nth Degree's management team in 2015. Nth Degree, headquartered in Duluth, GA, is a provider of exhibit management services and event services to clients across the globe.
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FORM | Hot Stocks16:35 EST FormFactor trading resumes
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BKH | Hot Stocks16:33 EST Black Hills' Wyoming utility receives approval for consolidation, rate increase - Black Hills Corp. announced that its Wyoming natural gas utility, Black Hills Wyoming Gas, LLC, doing business as Black Hills Energy, received approval from the Wyoming Public Service Commission of a settlement agreement allowing the company to consolidate its base rates and tariffs and for a general rate increase. This approval is the final step in Black Hills' utility jurisdiction consolidation process for Wyoming. Previously, Black Hills received approval and legally consolidated its four natural gas utilities in the state. This settlement agreement allows Black Hills Energy to establish statewide customer rates and consolidate general tariffs, gas cost adjustments, and certain riders and adjustment clauses. The new rates will generate an estimated $13.3 million in new annual revenue starting March 1, 2020, to recover Black Hills Energy's investment in utility infrastructure and increased operating expenses. The new revenue is based on a return on equity of 9.4 percent and a capital structure of 50.23 percent equity and 49.77 percent debt. The settlement agreement also allows Black Hills Energy to establish the Wyoming Integrity Rider to recover the costs of investments for integrity management programs designed to improve system reliability and safety.
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MGEN | Hot Stocks16:32 EST Miragen Therapeutics announces Diana Escolar CMO, $20M stock purchase agreement - The company announced a plan to streamline its operations, which it expects will result in the reduction of approximately 18 employees over the next seven months. The reductions are primarily in positions relating to research and development and corresponding project, general and administrative support. Miragen estimates that it will incur approximately $700,000 in restructuring charges primarily for severance and other related costs for the employees impacted by the reduction in force over the next seven months. In addition, the company plans to enter into severance and retention bonus agreements with its remaining workforce. The company also announced that Paul Rubin, executive VP of R&D, is leaving the company effective December 31 to spend more time with his family. Rubin remains "excited" about the potential of the company's technology and will continue to provide guidance and advice to Miragen through a consulting arrangement. With the departure of Rubin, the company has named Diana Escolar, as CMO. Escolar joined the company in January 2018 and has served as Miragen's senior VP of clinical sciences. Escolar has helped to lead the clinical development strategies and implement the company's clinical programs over the last two years. the company signed a $20M common stock purchase agreement with Aspire Capital Fund. Immediately following the execution of the purchase agreement, Aspire Capital purchased 1,598,465 shares of common stock at a price of $0.6256 per share. Miragen has the right to sell up to the remaining $19M of its common stock to Aspire Capital over a 30-month period, at prices based on a formula linked to current market prices at or around the time of each sale. The company also issued 959,079 shares of common stock to Aspire Capital in consideration for entering into the purchase agreement. Aspire Capital has the obligation to purchase common stock from Miragen in amounts and based on timing determined by Miragen in its sole discretion, subject to certain limits. The Purchase Agreement does not contain any restrictions on the use of the proceeds, financial or other covenants or restrictions. The company expects to use proceeds from the sale of common stock under the purchase agreement to advance the development of MRG-229, as well as general corporate purposes including business development initiatives.
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COT | Hot Stocks16:32 EST Cott Corp. board approves share repurchase of up to $50M - Cott Corporation announced that the company's board of directors has approved a new 12-month share repurchase program of up to $50M. Cott's board of directors has determined that the repurchase of a portion of Cott's outstanding common shares is an appropriate use of available cash and is in the best interests of Cott and its shareowners. In order to facilitate repurchases, the Toronto Stock Exchange has approved Cott's notice of intention to make a normal course issuer bid for a portion of its common shares as appropriate opportunities arise from time to time. The total size of the repurchase is capped at $50 million. Repurchases will be made through the facilities of the TSX, the New York Stock Exchange and other alternative Canadian trading systems in accordance with applicable regulatory requirements, including Rule 10b-18 of the Securities Exchange Act of 1934. Cott may begin to purchase common shares on or about December 16, 2019.
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R | Hot Stocks16:31 EST Ryder announces new 1.5M share repurchase program - Ryder System announced that its Board of Directors has authorized a new share repurchase program to mitigate the dilutive impact of shares issued under the company's employee stock plans. The new program replaces Ryder's previous anti-dilutive program, which expired in December 2019. Under the new anti-dilutive program, Ryder management is authorized to repurchase up to 1.5M shares of common stock issued to employees under the company's employee stock plans from December 1, 2019 through December 11, 2021.
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APT | Hot Stocks16:24 EST Alpha Pro Tech adds additional $2M to share repurchase program - Alpha Pro Tech announced that its board has authorized a $2.0M expansion of the company's existing share repurchase program. With this authorized expansion, the company now has approximately $2.2M available to repurchase shares of the company's common stock, $0.2M of which remains from the previous expansion announced in December 2018.
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MGEN | Hot Stocks16:24 EST Miragen Therapeutics to cut Phase 2 SOLAR enrollment, focus pipeline on MRG-229 - Miragen Therapeutics announced a series of strategic changes across its business that are intended to reallocate its existing capital to deliver milestones in 2020. These changes include a revised development strategy aimed at delivering data in 2020 from a modified Phase 2 SOLAR clinical trial of cobomarsen in cutaneous T-cell lymphoma, or CTCL, consulting with the FDA to define a development path for cobomarsen in adult T-cell leukemia/lymphoma, or ATLL, and focusing future pipeline development efforts primarily on MRG-229, a novel second generation miR-29 mimic and potential treatment in patients with idiopathic pulmonary fibrosis (IPF). Together with its updated development strategy, the company is streamlining operations and reallocating its existing resources, which includes a workforce reduction that will impact approximately 18 employees. After changes to the SOLAR clinical trial and the reduction in workforce, the company believes its cash and cash equivalents will now be sufficient to fund its operations into Q4 of 2020. The company announced that it will stop the enrollment of new patients in its Phase 2 clinical trial of cobomarsen, SOLAR, effective as of the end of the year. Patients enrolled in the trial at that time will continue to be evaluated for safety and clinical response. The company initially planned to enroll up to 126 patients and now expects to enroll approximately 30 patients. Despite the reduction in patient enrollment, the company believes that evaluation of data from this set of patients can provide important evidence regarding the safety and efficacy of cobomarsen for the treatment of CTCL in a shorter period of time and require fewer resources. The company also believes that obtaining controlled clinical data from this cohort of patients may allow for a better assessment of the clinical potential of cobomarsen as compared to data from its Phase 1 trial. The company intends for this controlled clinical data to form the basis of determining what additional clinical investigation of cobomarsen in CTCL is warranted, if any, and what would be required to potentially obtain regulatory approval. Topline data from this amended trial is expected to be announced in Q3 of 2020. In addition to CTCL, Miragen is also evaluating cobomarsen in a Phase 1 basket trial of other cancers where the disease process appears to be correlated with an increase in miR-155 levels, ATLL, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. In this clinical trial, the company believes that cobomarsen has demonstrated promising interim results in several ATLL patients. Based on these interim results, the company is announcing that it is focusing its cobomarsen expansion indication efforts on ATLL and will request a meeting with the FDA to explore a potential expedited development pathway for cobomarsen in ATLL. The company expects to have a meeting with the FDA in Q2. The company is developing miR-29 mimics or replacements for miR-29, a microRNA that is found at abnormally low levels in a number of pathological fibrotic conditions. The company's lead microRNA-29 mimics are remlarsen and MRG-229. Remlarsen is the company's most advanced product candidate in fibrosis, which is currently being evaluated in a Phase 2 clinical trial assessing its safety, tolerability, and activity in the potential prevention or reduction of keloid formation in patients with a history of keloid scars, a form of pathological scarring. The company reported interim data from this clinical trial, which suggests that remlarsen was generally safe and well tolerated, treatment had no negative effect on healing reported and initial volume reductions in treated keloids compared to placebo in a subset of patients were observed. Based on this data, the company has decided to continue its analysis of patient data at the one-year primary endpoint of the clinical trial. With this data, the company may seek a collaboration partner for the future development of remlarsen. In addition, based on preclinical data with MRG-229, the company announced that its pipeline development efforts and allocation of future capital will be primarily focused on the development of MRG-229 for IPF. The company believes that the efficacy and safety profile of MRG-229 positions it as a potentially differentiated approach to the treatment of IPF. Miragen expects to report additional preclinical-safety and -efficacy data during the first half of 2020. This program is supported by a grant in collaboration with the National Institutes of Health and Yale University.
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PDSB MRK | Hot Stocks16:23 EST PDS Biotechnology says Dr. Jared Weiss principal investigator in Versatile study - PDS Biotechnology (PDSB) announced that Dr. Jared Weiss, an internationally recognized expert in the field of thoracic and head and neck cancers and Faculty at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, will be the Principal Investigator for the Company's Phase 2 VERSATILE-002 study in collaboration with Merck (MRK). In addition, the Company has established an independent Data Monitoring Committee, DMC, that will be responsible for reviewing and evaluating patient safety and efficacy data in the upcoming Phase 2 study. Dr. Jared Weiss serves as the Section Chief of Thoracic and Head and Neck Oncology and has served as principal investigator on numerous industrial and investigator initiated immunotherapy clinical trials. He is the Vice President of Cancergrace.org, a global resource with the goal of increasing patient education and family information on cancer and is an advocate and board member of the Lung Cancer Initiative of North Carolina. Dr. Weiss holds a Doctor of Medicine from Yale University School of Medicine and a B.S. in neuroscience from Brown University. Dr. Weiss completed his residency in internal medicine at Beth Israel Deaconess Medical Center; and his medical oncology fellowship at the Hospital of the University of Pennsylvania. The combination study will evaluate the efficacy and safety of PDS Biotech's lead Versamune-based immunotherapy, PDS0101, in combination with Merck's anti-PD-1 therapy, KEYTRUDA, pembrolizumab, in the first-line treatment of patients with recurrent or metastatic human papillomavirus-16 positive head and neck cancer. The study is expected to be initiated in the next three to four months. "I look forward to working with PDS Biotech in collaboration with Merck on this Phase 2 study to evaluate the novel combination of PDS0101 and KEYTRUDA," commented Dr. Jared Weiss. "PDS0101's unique ability to promote the in-vivo induction of high levels of HVP16-specific CD8+ killer T-cells could hold the potential to overcome a significant limitation of checkpoint inhibitors and potentially play a critical role in expanding their clinical efficacy to a broader population of patients."
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ZTS | Hot Stocks16:22 EST Zoetis raises quarterly dividend 22% to 20c per share - The board of directors of Zoetis has declared a first quarter 2020 dividend payable to holders of the company's common stock of 20c per share, an increase of 22% from the quarterly dividend rate paid in 2019. The dividend is to be paid on Tuesday, March 3, 2020, to holders of record on Friday, January 17, 2020. "Zoetis continues to drive revenue growth and increase its financial strength through a diverse and innovative product portfolio that provides solutions across the continuum of animal care," said Glenn David, Executive Vice President and Chief Financial Officer. "We are well-positioned to generate cash for future growth and value creation opportunities, and I am pleased to announce that we are increasing our dividend by 22% in 2020 as part of our commitment to returning excess capital to shareholders."
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CVA | Hot Stocks16:22 EST Covanta to build new energy-from-waste facility in Zhao County, China - Covanta has signed a concession agreement with Zhao County, China for the construction and operation of a new Energy-from-Waste facility. The facility will provide a sustainable waste solution to the county and nearby jurisdictions. The project is being developed jointly by Covanta and a strategic local partner. China's EfW capacity targets are supported by a preferential tariff on the purchase of electricity from EfW facilities and other beneficial regulations that prioritize development of EfW infrastructure. In light of these policies, over 200 new EfW facilities are expected to be built between 2020 and 2030. A 30-year concession agreement guarantees waste supply under a build-own-operate-transfer structure. Facility construction is to be project financed, with total capital cost of approximately $100M. Covanta will be a project equity partner and will provide construction oversight services. Construction is expected to begin in early 2020 with completion in less than two years.
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AIG | Hot Stocks16:21 EST AIG extends tax asset protection plan - American International Group, Inc. announced that its Board of Directors has adopted Amendment No. 3 to AIG's Tax Asset Protection Plan. The Plan, which is designed to protect AIG's substantial tax assets, was scheduled to expire on December 14, 2019. Amendment No. 3 to the Plan extends the expiration date of the Plan to December 11, 2022 and makes minor technical changes to the Plan to remove provisions related to the U.S. Treasury's ownership of AIG equity interests that are no longer applicable since the U.S. Treasury no longer holds any equity interests in AIG. AIG's ability to use its tax attributes may be significantly limited if there were an "ownership change" as defined under Section 382 of the Internal Revenue Code and related Internal Revenue Service pronouncements. In general, an ownership change will occur when the percentage of AIG's ownership of one or more "5-percent shareholders" has increased by more than 50 percent over the lowest percentage owned by such shareholders at any time during the prior three years. The Plan is designed to reduce the likelihood that AIG will experience an ownership change by discouraging any person from becoming a 5-percent shareholder. There is no guarantee, however, that the Plan will prevent AIG from experiencing an ownership change.
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AB | Hot Stocks16:21 EST AllianceBernstein reports preliminary AUM $611B as of November 30 - Up from $601B at the end of October. The 1.7% increase was due to market appreciation, as well as total firmwide net inflows into all three distribution channels - Retail, Institutions and Private Wealth.
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UTX | Hot Stocks16:20 EST United Technologies names board members for future independent Carrier - United Technologies announced the appointments of an executive chairman and members of the board of directors for Carrier, a leading global provider of innovative HVAC, refrigeration, fire, security and building automation technologies. John Faraci, currently a member of the UTC Board of Directors, will serve as executive chairman of Carrier. David Gitlin, who was previously appointed president & CEO of Carrier, will join the board, as will current UTC director Jean-Pierre Garnier. The eight-member board will also include independent directors John Greisch, Charles Holley, Mike McNamara, Michael Todman and Virginia Wilson. The new board, which becomes effective upon the completion of Carrier's planned separation from UTC in 2020, is comprised of highly experienced executives from a diverse range of companies in sectors including technology, manufacturing, healthcare, asset management, and retail. They have led Fortune 100 companies, global finance functions, and international operations to deliver value to shareholders.
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OSG | Hot Stocks16:20 EST Overseas Shipholding, American Shipping extend tanker charters - Overseas Shipholding Group and American Shipping Company jointly announced that OSG has exercised options to extend its bareboat charter agreements with AMSC for four vessels currently under charter from AMSC. Each bareboat charter agreement was extended for additional three-year terms, commencing from December 2020 and ending in December 2023. OSG previously exercised its options to extend charter agreements for all of the six other vessels that it leases from AMSC. As a result, all ten bareboat charter agreements with AMSC have now been extended for additional periods. The bareboat charter agreements provide that the three- and five-year options for these vessels are available indefinitely. The lease payments for the bareboat charters are fixed throughout the option periods, and the options are on a vessel-by-vessel basis and can be exercised individually.
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UTX | Hot Stocks16:19 EST United Technologies names board members for future independent Otis - United Technologies announced the appointments of an executive chairman and members of the board of directors for Otis, the world's leading elevator and escalator company. Christopher Kearney, currently a member of the UTC Board of Directors, will serve as executive chairman of Otis. Judy Marks, who was previously appointed president & CEO of Otis, will join the board as will current UTC director Terry McGraw. The nine-member board will also include independent directors Jeffrey Black, Kathy Hopinkah Hannan, Shailesh Jejurikar, Margaret Preston, Shelley Stewart, Jr. and John Walker. The new board, which becomes effective upon the completion of Otis' planned separation from UTC in 2020, is comprised of deeply experienced executives from a diverse range of companies in sectors including high-tech manufacturing, asset management, consumer products, professional services and transportation. They have led companies as CEOs, presidents, COOs and CFOs.
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ASB | Hot Stocks16:19 EST Associated Banc-Corp Chief Credit Officer John Hankerd retiring in Q1 - Associated Banc-Corp announced changes involving its executive committee. Executive VP and Chief Credit Officer John Hankerd has announced his plans to retire from his role in 1Q20. Hankerd joined Associated in 2002 and has held multiple leadership roles in commercial and corporate banking. In anticipation of Hankerd's retirement, the company promoted Patrick Ahern to the position of Executive VP and Deputy Chief Credit Officer. Ahern will assume the Chief Credit Officer role in early 2020. Ahern joined Associated in 2010 and was promoted to Senior VP, Corporate Senior Credit Officer in 2018. He has more than 30 years of experience, including multiple leadership roles in commercial real estate and credit functions. He currently sits on the management committee and serves as treasurer for the Urban Land Institute - Chicago chapter.
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CLR COP | Hot Stocks16:18 EST Continental Resources names William Berry as CEO, Jack Stark as COO - Continental Resources (CLR) announced that effective January 1, 2020, Founder and CEO, Harold Hamm will step up to the role of Executive Chairman. William Berry has been appointed CEO and President Jack Stark will assume the additional role of COO. Bill Berry has spent over four decades in the oil and gas business, serving in a variety of roles, including as an executive with ConocoPhillips (COP).
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RRTS | Hot Stocks16:17 EST Roadrunner COO Michael Gettle to step down - Roadrunner announced that Michael Gettle, President and Chief Operating Officer, is leaving the company. He will continue to assist the company throughout the transition of his responsibilities over the next few months.
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CLGX | Hot Stocks16:16 EST CoreLogic initiates quarterly dividend of 22c per share - The dividend is payable on January 24, 2020 to shareholders of record on the close of business January 10, 2020.
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OCFC | Hot Stocks16:15 EST OceanFirst gets approvals for transactions with Two River, Country Bank - OceanFirst Financial announced that all regulatory approvals and all requisite shareholder approvals have been obtained in connection with OceanFirst's pending merger transactions with each of Two River Bancorp and Country Bank Holding Company. Two River Transaction: On December 5, Two River received the requisite shareholder approval for the merger of Two River and OceanFirst that was announced on August 9. As previously announced, the required regulatory approvals for the Two River Transaction have been obtained. OceanFirst and Two River expect the Two River Transaction to close effective on or about January 1. CYHC Transaction: On December 10, CYHC received the requisite shareholder approval for the merger of CYHC and OceanFirst that was announced on August 9. Additionally, on December 10, the New York State Department of Financial Services approved the CYHC Transaction. As previously announced, the Board of Governors of the Federal Reserve System and the Office of the Comptroller of the Currency each approved the CYHC Transaction on November 15. OceanFirst and CYHC expect the CYHC Transaction to close effective on or about January 1.
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LULU | Hot Stocks16:15 EST Lululemon down over 4% at $223.75 after Q3 results and updated guidance
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STRL | Hot Stocks16:14 EST Sterling Construction announces passing of chairman Milton Scott - Sterling Construction Company announced the passing of Milton L. Scott, a director and the chairman of the board of the company. Scott had been a member of the company's board since 2005 and was elected chairman of the board of directors of the company in March of 2015. In light of Scott's passing, on December 10, 2019, the company held a special meeting of the board of directors to appoint Thomas M. White as the chairman of the board, who will serve out the remainder of the chairman's term until the next shareholder meeting. White's appointment was part of the board's planned chairman succession plan.
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VCTR | Hot Stocks16:13 EST Victory Capital reports AUM of $149.5B as of November 30th vs $146.8B last month - Victory Capital reported assets under management of $149.5B on November 30, 2019.
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OFG BNS | Hot Stocks16:12 EST OFG receives regulatory approvals for Scotiabank Puerto Rico deal - OFG Bancorp (OFG) announced receipt of regulatory approvals from the Board of Governors of the Federal Reserve System, Federal Deposit Insurance Corporation and the Office of the Commissioner of Financial Institutions of Puerto Rico required for its banking subsidiary, Oriental Bank, to consummate the previously announced acquisition of the Puerto Rico and US Virgin Islands operations of Scotiabank (BNS). OFG's previously announced acquisition of Scotiabank's US Virgin Islands operations remains subject to receipt of final approval and related licenses from the US Virgin Islands Banking Board. OFG expects to complete the acquisition by December 31, 2019. Upon closing, Scotiabank's PR and USVI operations will further strengthen Oriental's position as the premier retail bank in Puerto Rico. Oriental will have the second largest market share in Puerto Rico in core deposits, branches, automated and interactive teller machines, mortgage servicing, and insurance brokerage, in addition to becoming the third largest bank in USVI by deposits. Upon closing and for a transitional period, Oriental will continue using the Scotiabank technology platforms. As a result, customers can interact with the bank, and use branches, as they do currently without any need for change. In addition, customers will be able to use all Oriental ATMs at no charge and make credit card, mortgage, auto and personal loan payments and make deposits by check through express mailboxes in all branches.
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OLP | Hot Stocks16:12 EST One Liberty Properties sells Texas property for $16.6M - One Liberty Properties announced that it sold an 87,500 square foot assisted living facility in Round Rock, Texas, for a sales price of $16.6M, of which $13.2M was used to repay the mortgage debt associated with the property. The company anticipates that during the three months ending December 31, it will recognize an approximate $435,000 gain from this sale, without giving effect to a $625,000 mortgage swap termination fee. Net of the fee and excluding the effect of a 2018 write-off related to this property, the sale will result in a net loss of approximately $190,000. The company will also recognize, in the quarter ending December 31, $584,000 in rental income reflecting its application of the security deposit of the tenant-debtor. The company intends to continue to pursue legal action against the guarantor of the lease for the damages it sustained.
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GILD | Hot Stocks16:11 EST Kite submits BLA to FDA for second CAR T cell therapy - Kite, a Gilead company, announced that it has submitted a Biologics License Application to the U.S. Food and Drug Administration for the investigational chimeric antigen receptor T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. The BLA submission is based on data from the Phase 2 ZUMA-2 trial, which demonstrated an overall response rate of 93 percent, including 67 percent with complete response, as assessed by an Independent Radiologic Review Committee following a single infusion of KTE-X19. In the safety analysis, Grade 3 or higher cytokine release syndrome and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred. Detailed findings from this trial were recently presented at the 61st American Society of Hematology Annual Meeting & Exposition in Orlando. Kite plans to submit a Marketing Authorization Application for KTE-X19 in the European Union in early 2020. KTE-X19 has been granted Breakthrough Therapy Designation by the FDA and Priority Medicines by the European Medicines Agency for relapsed or refractory MCL.
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NLS GPS | Hot Stocks16:09 EST Nautilus names Aina Konold CFO - Nautilus (NLS) announced that Aina Konold has been appointed Chief Financial Officer, effective on December 10, 2019. Previously, Konold held several executive level finance positions during her 20-year career with Gap (GPS) including senior leadership roles across financial planning and analysis, real estate strategy, and investor relations. Most recently, she was the founding CFO for Gap Inc. in China where she grew store count from four to over 175 stores.
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TNXP | Hot Stocks16:08 EST Tonix Pharmaceuticals awarded European patent - Tonix Pharmaceuticals Holding Corp. announced that the European Patent Office issued European Patent No. 2968992 to the company. This patent, "Eutectic Formulations of Cyclobenzaprine Hydrochloride and Mannitol," includes 14 claims directed to compositions comprising eutectics of cyclobenzaprine hydrochloride and mannitol and methods of making those compositions. This patent is expected to provide Tonix with market exclusivity until 2034.
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JACK | Hot Stocks16:08 EST Jack in the Box board initiates succession planning process for CEO Comma - The board of directors of Jack in the Box announced that it has retained Spencer Stuart to assist the company in identifying an individual to succeed its Chairman and Chief Executive Officer, Lenny Comma. Although Comma has not set a specific date to leave the company, he has informed the Board that he believes now is an appropriate time for the company to move forward with identifying a successor with whom Comma can work on a smooth and efficient transition of leadership. The Board's search will include both internal and external candidates. "I'm proud of what the company has been able to accomplish during my tenure as Chairman and CEO," said Comma. "Since 2014, we've sold Qdoba, finished our evolution to an asset-light brand by completing our refranchising efforts, gone through a rigorous strategic alternatives process, completed a very complex $1.3 billion securitization transaction, dramatically strengthened our operations leadership bench, and recently concluded our ninth straight year of system same-store sales growth." Comma continued, "I'm committed to working with the Board to identify a successor who will continue to grow this exceptional brand, and to working closely with that successor to assure a smooth and successful leadership transition for the company and its stakeholders, including our incredible guests, employees, franchisees, suppliers and, of course, shareholders."
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OKE | Hot Stocks16:08 EST Oneok completes Elk Creek pipeline - Oneok completed its Elk Creek Pipeline. Natural gas liquids volume is now flowing on the fully completed 900-mile pipeline, which extends from the Williston Basin to Oneok's existing Mid-Continent NGL facilities in Bushton, Kansas. Elk Creek has the capacity to transport up to 240,000 barrels per day of unfractionated NGLs and the capability to be expanded to 400,000 bpd with additional pump facilities. Oneok expects total Rocky Mountain NGL volume transported on the Elk Creek and Bakken NGL pipelines to reach more than 240,000 bpd by the end of 1Q20.
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TLRY | Hot Stocks16:08 EST Tilray Portugal receives second Good Manufacturing Practice certification - Tilray announced this morning that its wholly-owned subsidiary Tilray Portugal has received its Good Manufacturing Practice certification in accordance with European Union standards, for its manufacturing facility in Cantanhede, Portugal. The GMP certification was issued by Infarmed, the Portuguese National Authority of Medicines and Health Products. This is the second GMP certification for Tilray Portugal, which allows the facility to manufacture and export GMP-certified finished medical cannabis products, including dried flower and oils, from Portugal to international markets with legal medical cannabis regulations, the company said. "We are pleased with the continued momentum of our growth strategy across Europe with this additional GMP certification for Tilray's EU campus in Portugal," says Brendan Kennedy, Tilray CEO. "This will enable us to export a greater range of medical products to international patients, partners and markets. Our international strategy is an important component in driving profitability and long-term shareholder value."
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ALEC | Hot Stocks16:07 EST Alector appoints Shehnaaz Suliman COO - Alector announced the appointment of Shehnaaz Suliman as the company's president and COO. She joins Alector from Theravance Biopharma, where she served as senior VP, corporate development and strategy, a position she held from July 2017 to March 2019.
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OZK | Hot Stocks16:06 EST Bank OZK plans significant investment in solar energy power plant - Bank OZK announced plans for a significant investment for the construction of a solar power plant which will provide enough renewable energy to power its new corporate headquarters and up to 40 other Arkansas locations, according to Tim Hicks, Chief Administrative Officer. The Bank's investment of over $6M represents the largest investment in renewable energy by an Arkansas-based financial services company to date. The solar power plant, expected to be located in Central Arkansas, will be the third-largest commercial solar facility dedicated to a private sector customer in the State of Arkansas, and will have generating capacity of 4.8-megawatts DC of electricity.
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MN | Hot Stocks16:05 EST Manning & Napier reports preliminary AUM $19.3B as of November 30 - Consistent with October 31, and compared with $20.5B at September 30.
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YRCW | Hot Stocks16:05 EST YRC Worldwide says October LTL tonnage per day decreased approximately 4.5% - YRC Worldwide reported certain operating metrics for the first two months of fourth quarter 2019. At YRC Freight, October 2019 less-than-truckload, LTL, tonnage per day decreased approximately 4.5% compared to October 2018 and November 2019 LTL tonnage per day decreased approximately 10.2% compared to November 2018. Quarter-to-date through November 2019, LTL revenue per hundredweight decreased approximately 0.9% and LTL revenue per shipment increased approximately 1.8% compared to a year ago. At the Regional segment, October 2019 LTL tonnage per day decreased approximately 5.7% compared to October 2018 and November 2019 LTL tonnage per day decreased approximately 11.2% compared to November 2018. Quarter-to-date through November 2019, LTL revenue per hundredweight decreased approximately 0.8% compared to a year ago. LTL revenue per shipment remained flat when compared to last year. "The industrial freight slowdown, which started its decline more than 14 months ago, has created a freight volume headwind," said Darren Hawkins, Chief Executive Officer at YRC Worldwide. "The year over year comparisons for November were impacted due to operating conditions at a primary competitor in November of last year and a later Thanksgiving impacting retail. The December tonnage per day levels are trending more in line with October results from a year over year comparison."
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LSCC | Hot Stocks16:02 EST Lattice Semiconductor, SiFive collaborate over RISC-V processors - SiFive and Lattice Semiconductor Corporation announced they have agreed to collaborate to enable easy availability of SiFive scalable Core IP for developers using Lattice FPGA product families, including Lattice's new 28 nm CrossLink-NX FPGAs. "Lattice is pleased to be collaborating with SiFive to enable easy customer access to the SiFive Core IP on our small form factor, low power FPGAs," said Esam Elashmawi, Chief Marketing & Strategy Officer, Lattice Semiconductor. "SiFive's flexible and scalable RISC-V based Core IP running on our FPGAs will provide developers with a compelling hardware solution for emerging applications such as embedded vision and AI processing on Edge devices."
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ANFI | Hot Stocks16:01 EST Amira Nature Foods announces reverse stock split - Amira Nature Foods announced that on December 4, 2019, its board of directors approved a 20:1 reverse stock split of its ordinary shares. The company's ordinary shares will begin trading on a split adjusted basis on December 20, 2019. As a result of the reverse stock split, each twenty pre-split shares of the company's ordinary stock will automatically combine into one ordinary share without any action on the part of the holders, and the number of outstanding ordinary shares will be reduced from 44,421,835 to approximately 2,221,091 ordinary shares. The company's ordinary shares will continue to trade on the New York Stock Exchange under the symbol "ANFI" but will trade under a new CUSIP number. The reverse split is intended to increase the market price per share of the company's ordinary shares to allow the company to maintain its New York Stock Exchange listing.
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AMGN | Hot Stocks16:00 EST Amgen raises quarterly dividend 10% to $1.60 per share - Amgen announced that its Board of Directors declared a $1.60 per share dividend for the first quarter of 2020. The dividend will be paid on March 6, 2020, to all stockholders of record as of the close of business on Feb. 14, 2020. This represents a 10% increase from that paid in each of the previous four quarters. Since the company initiated a dividend in 2011, it has increased the dividend each year with the quarterly payout in 2019 up more than five-fold since its inception.
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FORM | Hot Stocks16:00 EST FormFactor trading halted, news pending
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TTEK | Hot Stocks15:58 EST Tetra Tech awarded $21M contract from EPA - Tetra Tech announced the U.S. Environmental Protection Agency's Office of Science and Technology awarded Tetra Tech a $21M, single-award contract to support the Agency's mission in assessing and managing threats to ecological and human health. EPA/OST is responsible for developing science-based and technological foundations to achieve clean water through national programs that protect people and the aquatic environment. Under the five-year contract, Tetra Tech will evaluate the fate and transport of contaminants and pathogens using advanced predictive models, and assess risks to ecological and human health. Scientists in Tetra Tech's in-house ecotoxicology laboratory will analyze water, fish tissue, and sediment samples to determine the geographic extent and severity of various contaminants of concern. Tetra Tech also will support EPA in compiling, maintaining, and performing advanced analytics on large-scale, national environmental datasets. Tetra Tech researchers will use the information from these datasets to prepare technical reports, design monitoring programs, and create guidance documents to advance the protection of ecological and human health.
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AYX | Hot Stocks15:43 EST Spruce Point says long Alteryx, calls short report rumor 'categorically false' - Spruce Point Capital tweeted: "We are LONG shares of Alteryx, Inc. $AYX It is our understanding that one factor driving today's selling in the stock is a belief that Spruce Point is planning on a releasing a short report. Categorically false. #fakenews ... We have NO plans to release a such a report and our historical diligence suggests $AYX is at the forefront of data analytics and has an extremely sticky market position with a long runway of growth opportunity #bullish" Reference Link
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FTNW | Hot Stocks15:04 EST FTE Networks Inc trading halted, news pending
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MGI | Hot Stocks15:02 EST MoneyGram extends partnership agreement with CVS for three years - MoneyGram (MGI) announced that it is extending its "longstanding partnership" with CVS (CVS). "We are extremely honored to extend our relationship with CVS for another three years. CVS likes to say that it prides itself on informally standing for 'convenience, value and service,' which aligns perfectly with our corporate vision. We look forward to a continued partnership that provides our shared customers with great service at a good value," said Alex Holmes, MoneyGram president and CEO.
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SPOT NFLX | Hot Stocks14:35 EST Netflix announces scripted series about Swedish start-up Spotify - Netflix (NFLX) announced the untitled scripted series about the scripted series about the Swedish start-up that shook the entire music industry and evolved into becoming one of the world's leading music services - Spotify (SPOT). The limited series is inspired by the book 'Spotify Untold' by authors Sven Carlsson and Jonas Leijonhufvud - both business reporters at Swedish Dagens Industri - and will be produced by Yellow Bird UK, a Banijay Group company and the production company behind the upcoming Netflix series Young Wallander. Acclaimed Per-Olav Sorensen will be directing and Berna Levin (Young Wallander, Hidden and The Girl in the Spider's Web) will serve as executive producer. Reference Link
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GOOG | Hot Stocks14:21 EST Google introduces E2 line of virtual machines with 'dynamic resource management' - In a blog posting from earlier, Google said: "General-purpose virtual machines are the workhorses of cloud applications.We are excited to announce our E2 family of VMs for Google Compute Engine featuring dynamic resource management to deliver reliable and sustained performance, flexible configurations, and the best total cost of ownership of any of our VMs. Now in beta, E2 VMs offer similar performance to comparable N1 configurations, providing: Lower TCO: 31% savings compared to N1, offering the lowest total cost of ownership of any VM in Google Cloud. Consistent performance: Your VMs get reliable and sustained performance at a consistent low price point. Unlike comparable options from other cloud providers, E2 VMs can sustain high CPU load without artificial throttling or complicated pricing. Flexibility: You can tailor your E2 instance with up to 16 vCPUs and 128 GB of memory. At the same time, you can provision only the resources that you need with 15 new predefined configurations or the ability to use custom machine types." Reference Link
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PNRG | Hot Stocks13:15 EST PrimeEnergy director Clint Hurt sells over $1.1M in company shares - PrimeEnergy director Clint Hurt disclosed in a filing that he had sold 7,379 shares of company stock at am average price of $152.95 per share on December 6. The total transaction value of the sale was $1,128,618.
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CSCO CMCSA | Hot Stocks12:45 EST Cisco announces 'Internet for the Future' strategy - Cisco (CSCO) unveiled further details behind its technology strategy for building a new internet "designed to push digital innovation beyond the performance, economic and power consumption limitations of current infrastructure." Cisco introduced Cisco Silicon One, which it calls "the industry's only networking silicon architecture of its kind." The company also released the new Cisco 8000 Series, which it calls "the world's most powerful carrier class routers built on the new silicon." Additionally, Cisco announced new purchasing options that it said "enable customers to consume the company's technology through disaggregated business models." Cisco added that it is working with "a group of pioneering customers on deployments and trials of the Cisco 8000 Series." STC, the "leading telecom services provider in the Middle East, Northern Africa region," marks the first customer deploying the new technology. Ongoing trials include Comcast (CMCSA) and NTT Communications among others.
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SPX SPY | Hot Stocks12:45 EST Gundlach says in next recession, U.S. will be worst stock market in world - DoubleLine CEO Jeffrey Gundlach is speaking on CNBC.
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SPX SPY | Hot Stocks12:41 EST Gundlach says Hillary Clinton would be strongest Democratic candidate - DoubleLine CEO Jeffrey Gundlach is speaking on CNBC.
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CNMD | Hot Stocks12:41 EST Conmed VP John Kennedy sells almost $700K in company shares - Conmed VP John Kennedy disclosed in a filing that he had sold 5,965 shares of company stock at an average price of $112.42 per share on December 9. The total transaction value of the sale was $670,585.
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SPX SPY | Hot Stocks12:40 EST Gundlach says Trump winning reelection more positive than negative for market - DoubleLine CEO Jeffrey Gundlach is speaking on CNBC.
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SPX SPY | Hot Stocks12:40 EST Gundlach says Elizabeth Warren is 'done' amid collapsing poll numbers - DoubleLine CEO Jeffrey Gundlach is speaking on CNBC.
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ETFC | Hot Stocks12:39 EST E-Trade says rumor that company has been approached 'patently false' - Says the rumor that the company has been approached and shunned that approach at least once is "patently false." The company says generating shareholder value is the top priority for the board and management team. "Bigger is not always better," the company adds. Comments taken from the Goldman Sachs U.S. Financial Services Conference.
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SPX SPY | Hot Stocks12:39 EST Gundlach says Elizabeth Warren is 'done' amid collapsing pool numbers - DoubleLine CEO Jeffrey Gundlach is speaking on CNBC.
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SPX SPY | Hot Stocks12:38 EST Gundlach says Bloomberg 'has no chance' to win nomination - DoubleLine CEO Jeffrey Gundlach is speaking on CNBC.
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SPX SPY | Hot Stocks12:36 EST Gundlach says his 'base case' is President Trump wins reelection - DoubleLine CEO Jeffrey Gundlach is speaking on CNBC.
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NSRGY | Hot Stocks12:33 EST Nestle to sell U.S. ice cream business to Froneri JV in $4B transaction - Nestle announced that it has reached an agreement to sell its U.S. ice cream business to Froneri, an ice cream-focused joint venture Nestle created in 2016 with PAI Partners, for a transaction value of $4B. "In 2016, Nestle and PAI Partners merged Nestle's European ice cream business in 20 countries and PAI-owned R&R to create Froneri, one of the world's largest ice cream companies. With a portfolio of iconic brands, unparalleled ice cream knowledge and focus as well as an agile and entrepreneurial management style, Froneri has been able to achieve rapid sales and profit growth, steadily gaining market share and reaching a turnover of around CHF 2.9 billion in 2018. Froneri, which already had operations in Europe, Latin America, Africa and Asia-Pacific will now have a strong presence in the U.S., the largest ice cream market in the world. The recent acquisitions of TipTop in New Zealand and Nestle's ice cream business in Israel have also increased Froneri's growing global footprint," the company stated. The transaction is expected to close in the first quarter of 2020, following the completion of customary regulatory approvals. Nestle will continue to manage its remaining ice cream businesses in Canada, Latin America and Asia as part of its current market structure.
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SPX SPY | Hot Stocks12:22 EST Gundlach says now is time to exit corporate bond market - DoubleLine CEO Jeffrey Gundlach is speaking on CNBC.
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SPY SPX | Hot Stocks12:12 EST Gundlach says phase one trade deal looks like phase 'point one' - DoubleLine CEO Jeffrey Gundlach is speaking on CNBC.
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SPY SPX | Hot Stocks12:12 EST Gundlach sees no trade deal with China before 2020 election - DoubleLine CEO Jeffrey Gundlach is speaking on CNBC.
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SPY SPX | Hot Stocks12:10 EST Gundlach says odds are against recession through end of 2020 - DoubleLine CEO Jeffrey Gundlach is speaking on CNBC.
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INTC | Hot Stocks12:03 EST Intel announces RealSense lidar camera L515 built for indoor applications - Intel announced the Intel RealSense lidar camera L515, the world's smallest and most power-efficient, high-resolution lidar that captures millions of depth points per second. Designed with proprietary technology that creates entirely new ways to incorporate lidar into smart devices to perceive the world in 3D, the L515 provides high-quality performance and millimeter accuracy to products that require vision capabilities. "Intel RealSense technology is used to develop products that enrich people's lives by enabling machines and devices to perceive the world in 3D. With the L515 depth camera, we are excited to bring high-resolution lidar performance to markets previously inaccessible to this technology,"Sagi BenMoshe, corporate vice president, Intel RealSense Group. Reference Link
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CYTK | Hot Stocks12:03 EST Cytokinetics treatment of amyotrophic lateral sclerosis granted orphan status - Cytokinetics' reldesemtiv was granted orphan status by the FDA as a treatment of amyotrophic lateral sclerosis, according to a post to the agency's website. Reference Link
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SPX SPY | Hot Stocks12:01 EST Gundlach says Fed will keep rates unchanged today - DoubleLine CEO Jeffrey Gundlach is speaking on CNBC.
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SSI | Hot Stocks12:00 EST Stage Stores falls -10.6% - Stage Stores is down -10.6%, or -71c to $6.00.
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GME | Hot Stocks12:00 EST GameStop falls -19.0% - GameStop is down -19.0%, or -$1.23 to $5.28.
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UNFI | Hot Stocks12:00 EST United Natural Foods falls -25.7% - United Natural Foods is down -25.7%, or -$2.54 to $7.33.
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CTRA | Hot Stocks12:00 EST Contura Energy rises 8.5% - Contura Energy is up 8.5%, or 56c to $7.11.
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KODK | Hot Stocks12:00 EST Kodak rises 12.7% - Kodak is up 12.7%, or 35c to $3.10.
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PACK | Hot Stocks12:00 EST Ranpak Holdings rises 12.9% - Ranpak Holdings is up 12.9%, or 76c to $6.63.
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USB | Hot Stocks11:56 EST U.S. Bancorp now sees Q4 NIM down about 9bps vs. previous 7bp guidance - Says expects to achieve positive operating leverage on a FY basis. Sees Q4 NII down y/y in the low single digits. Says loan growth "probably going to be a little bit softer" in the corporate side, says overall growth "pretty similar to what we've experienced" in the last few quarters. Comments taken from the Goldman Sachs U.S. Financial Services Conference.
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BMWYY... | Hot Stocks11:46 EST BMW to integrate Android Auto into its vehicles starting in mid-2020 - The BMW Group (BMWYY) announced that it is extending the reach of connectivity in its vehicles with the introduction of Android Auto (GOOG) starting in mid-2020. Android Auto, the latest digital and user-centric service addition to BMW, will allow customers to connect their Android smartphones wirelessly with their vehicle and, in doing so, enjoy access to useful information like suggested destinations and upcoming appointments just when it is needed. Android Auto in a BMW will be demonstrated live for the first time at the Consumer Electronics Show 2020 and will be available for customers in 20 countries from July 2020 for all vehicles with BMW Operating System 7.0.
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CHSCP | Hot Stocks11:33 EST CHS obtains exclusive rights to Corteva Agriscience sunflower breeding program - CHS announced that it has obtained exclusive breeding and distribution rights to the Corteva Agriscience confectionary sunflower and conoil sunflower programs in North America. This will expand the number of sunflower hybrids available to CHS contract growers and farmer-owners and provide more high-value market opportunities. Corteva sunflower variety nomenclature will remain constant, but will be rebranded under the CHS Royal Hybrid brand. For the 2020 growing season, Corteva Agriscience conoil hybrid sunflower seeds will be marketed directly through CHS Sunflower and select CHS retail locations. Beginning in 2021, CHS will add the full portfolio of Corteva Agriscience confectionary sunflower seed to the Royal Hybrid line up.
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TRXC | Hot Stocks11:31 EST TransEnterix announces one-for-thirteen reverse stock split - TransEnterix announced that, following approval of a reverse stock split range and authorized share reduction by stockholders at a special meeting of stockholders, the TransEnterix's board determined to effect a reverse stock split of TransEnterix's common stock at a ratio of one-for-thirteen. The reverse split will become effective at 5:00 pm ET on December 11.
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TM | Hot Stocks11:31 EST Toyota announces executive leadership changes in North America - Toyota Motor North America announced executive leadership changes. Effective April 1, 2020, Jim Lentz, chief executive officer TMNA, will retire after 38 years with the company. Tetsuo "Ted" Ogawa, chief operating officer TMNA, will succeed Lentz as CEO, reporting to Didier Leroy, TMNA Vice Chairman and president of business planning and operations, Toyota Motor Corporation.
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ALGT | Hot Stocks11:06 EST Allegiant Travel reports November scheduled service RPMs up 1.6% - Allegiant Travel reported preliminary passenger traffic results for November, reporting revenue passenger miles for scheduled service were up 1.6% from the same month of last year. Scheduled service available seat miles were up 4.2% year-over-year and total system ASMs, which include scheduled service and fixed fee contract, were up 3.7% in November compared to last year.
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HII | Hot Stocks11:05 EST Huntington Ingalls appoints Bharat Amin as EVP, CIO - Huntington Ingalls Industries announced that Bharat Amin has been named EVP and chief information officer. In this newly created position, Amin will be responsible for establishing the company's information technology and digital strategic direction with a focus on cyber security capabilities through engagement with HII's executive and division leadership teams. In collaboration with the business units, Amin will lead corporate IT governance and provide functional oversight. He will assume his new role on Jan. 1 and will report to Mike Petters, HII's president and CEO. Amin joins the HII executive team after serving as vice president and CIO for Newport News Shipbuilding division since 2014.
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LOGM | Hot Stocks10:59 EST LogMein trading resumes
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LOGM | Hot Stocks10:58 EST LogMeln up 6% after report of private equity takeover talks - Shares of LogMeIn are up $4.56, or 6.2%, to $78.60 after Bloomberg's Nabila Ahmed, Kiel Porter and Scott Deveau reported that private equity firm Francisco Partners Management has partnered with hedge fund Elliott Management to make a bid to take LogMeIn private for more than $4B. The report, which cites people familiar with the matter, said the investment firms are in advanced talks to buy LogMein and a deal could be announced in the coming weeks.
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LOGM | Hot Stocks10:54 EST LogMein trading halted, volatility trading pause
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ALKS | Hot Stocks10:40 EST FDA issues warning letter to Alkermes over print ad for Vivitrol - In a warning letter dated December 2 that was addressed to Alkermes Chairman and CEO Richard Pops, the FDA stated in part: "The Office of Prescription Drug Promotion of the U.S. Food and Drug Administration has reviewed a print advertisement for Vivitrol submitted by Alkermes,under cover of Form FDA 2253. The print ad is false or misleading because it omits important risk information associated with the use of Vivitrol. Thus, the print ad misbrands Vivitrol within the meaning of the Federal Food, Drug and Cosmetic Act and makes its distribution violative... OPDP requests that Alkermes immediately cease misbranding Vivitrol and/or cease introducing the misbranded drug into interstate commerce. Please submit a written response to this letter on or before December 16." Reference Link
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MGNX | Hot Stocks10:07 EST MacroGenics halted for volatility after dropping 11% to $8.33
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MGNX | Hot Stocks10:06 EST MacroGenics trading resumes
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KZIA | Hot Stocks10:06 EST Kazia Therapeutics says lead program selected for glioblastoma study - Kazia Therapeutics announced that its lead program, GDC-0084, has been selected to join GBM AGILE, an international, academic-led, multi-drug adaptive phase II / III study in glioblastoma. It is expected that data from GBM AGILE will be used to seek marketing approval for GDC-0084 from FDA and other regulatory agencies. The study is designated phase II / III and data from it is considered acceptable for product registration purposes by the FDA, Kazia said. It has entered into a preliminary agreement to commence planning and set-up activities for inclusion of GDC-0084 in GBM AGILE, with a view to commencing recruitment in Q2/Q3 of 2020, subject to a definitive agreement. Kazia plans to participate in GBM AGILE in place of a company-run registration study, and GBM AGILE will serve as the path-to-market for GDC-0084, it added. Dr Timothy Cloughesy, GBM AGILE Global Principal Investigator, commented, "We see an urgent need for new therapies in glioblastoma, and GBM AGILE has been designed to provide an opportunity for industry to test new therapeutic agents in a cutting-edge, registration-level study, at considerably lower cost and in a faster time than would typically be possible for a company-driven study. GDC-0084 has the potential to become an important treatment option for brain cancer, and this study is the best way to definitively determine its efficacy in this challenging disease." The study commenced recruitment of its first investigational arm in June 2019.
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MGNX | Hot Stocks10:04 EST MacroGenics: Margetuximab didn't reach statistical significance in analysis - MacroGenics presented updated results from the Phase 3 SOPHIA study comparing margetuximab plus chemotherapy versus trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer who have previously been treated with anti-HER2-targeted therapies. Margetuximab is an investigational, immune-enhancing monoclonal antibody derived from the Company's proprietary Fc-engineering technology platform. The data were presented today during an oral session at the San Antonio Breast Cancer Symposium by Dr. Hope Rugo, M.D., Director, Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center. Overall survival results favored margetuximab plus chemotherapy compared with trastuzumab and chemotherapy in the intention-to-treat population; however, these data did not reach statistical significance at this second interim analysis as of a September 2019 cut-off after 270 events. The final pre-specified OS analysis is planned after 385 events have accrued, which is projected to occur in the second half of 2020. A pre-specified exploratory objective of the study was to evaluate the effect of CD16A allelic variation on margetuximab activity. Among the genetically defined subpopulation of patients carrying a CD16A 158F allele, who represent approximately 85% of the human population, the median OS at the second interim analysis was prolonged by 4.3 months in the margetuximab arm compared to the trastuzumab arm.
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MGNX | Hot Stocks10:01 EST MacroGenics trading halted, volatility trading pause
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SGEN | Hot Stocks09:58 EST Seattle Genetics says tucatinib shows statistical benefit in breast cancer study - Seattle Genetics announced "positive" pivotal data from the HER2CLIMB trial evaluating tucatinib in patients with HER2-positive metastatic breast cancer were presented at the San Antonio Breast Cancer Symposium and simultaneously published in the New England Journal of Medicine. The HER2CLIMB trial compared tucatinib in combination with trastuzumab and capecitabine to trastuzumab and capecitabine alone in patients with unresectable locally advanced or metastatic HER2-positive breast cancer. The primary endpoint of progression-free survival showed that the addition of tucatinib was superior to trastuzumab and capecitabine alone, with a 46% reduction in the risk of disease progression or death. Estimated PFS at one year was 33% in the tucatinib arm, compared to 12% in the trastuzumab and capecitabine arm. Median PFS was 7.8 months in the tucatinib arm, compared to 5.6 months in the control arm. For patients with brain metastases at baseline, a key secondary endpoint, the tucatinib arm also demonstrated superior PFS compared to trastuzumab and capecitabine alone, the company said. Findings demonstrated that the tucatinib regimen resulted in a 52% reduction in the risk of disease progression or death, compared to the control arm. The confirmed objective response rate in the patient population with measurable disease at baseline was 40.6% in the tucatinib arm, compared with 22.8% for trastuzumab and capecitabine alone. Tucatinib in combination with trastuzumab and capecitabine was generally well tolerated, said Seattle. Discontinuation of tucatinib and placebo due to adverse events was 5.7% in the tucatinib arm and 3% in the control arm. Roger Dansey, Chief Medical Officer at Seattle Genetics, said, "Tucatinib demonstrated a statistically significant and clinically meaningful benefit in overall survival, progression-free survival and objective response rate compared to the control arm. We plan to submit a New Drug Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency by the first quarter of 2020, with the goal of bringing a much-needed new medicine to patients."
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GOOG GOOGL | Hot Stocks09:48 EST YouTube bans malicious insults based on race, sexual orientation - In an update to its harassment policy, YouTube said it will no longer allow anyone to post content that "maliciously insults" others based on protected traits like race, gender expression and sexual orientation. The company will now suspend members of its YouTube Partner Program for channels "that repeatedly brush up against our harassment policy," and said it may also consider removing content from the channel and potentially terminating the channel if the behavior continues. YouTube commented: "We remain committed to our openness as a platform and to ensuring that spirited debate and a vigorous exchange of ideas continue to thrive here. However, we will not tolerate harassment and we believe the steps outlined will contribute to our mission by making YouTube a better place for anyone to share their story or opinion." Reference Link
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HZNP | Hot Stocks09:48 EST FDA posts briefing documents for panel meeting to review Horizon Pharma BLA - The FDA has posted to its website the background information prepared by the Food and Drug Administration for the panel members of the Dermatologic and Ophthalmic Drugs Advisory Committee who are meeting on December 13 to discuss the biologics license application, or BLA, for teprotumumab solution for intravenous use, submitted by Horizon Pharma, proposed for the treatment of active Thyroid Eye Disease, or TED. In the documents, the FDA staff write: "Efficacy, as demonstrated by a reduction in proptosis, has been demonstrated in two adequate and well controlled studies...The overall incidence of Muscle spasms was higher in the teprotumumab group compared to the placebo group...The mechanism of action for the muscle spasms remains unknown. Physician labeling could include Warning/Precaution of the possibility of teprotumumab being associated with muscle spasms." Reference Link
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GMRE | Hot Stocks09:47 EST Global Medical REIT falls -8.0% - Global Medical REIT is down -8.0%, or -$1.13 to $13.00.
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UNFI | Hot Stocks09:47 EST United Natural Foods falls -13.0% - United Natural Foods is down -13.0%, or -$1.28 to $8.59.
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GME | Hot Stocks09:47 EST GameStop falls -14.0% - GameStop is down -14.0%, or -91c to $5.60.
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SBGL | Hot Stocks09:47 EST Sibanye-Stillwater rises 5.3% - Sibanye-Stillwater is up 5.3%, or 45c to $8.95.
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PACK | Hot Stocks09:47 EST Ranpak Holdings rises 5.5% - Ranpak Holdings is up 5.5%, or 32c to $6.19.
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CHH | Hot Stocks09:47 EST Choice Hotels rises 5.4% - Choice Hotels is up 5.4%, or $5.24 to $102.52.
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TWTR SQ | Hot Stocks09:41 EST Dorsey: Twitter funding team to develop decentralized standard for social media - Twitter (TWTR) CEO Jack Dorsey tweeted that the company is "funding a small independent team of up to five open source architects, engineers, and designers to develop an open and decentralized standard for social media. The goal is for Twitter to ultimately be a client of this standard." He added that "Twitter was so open early on that many saw its potential to be a decentralized internet standard, like SMTP (email protocol). For a variety of reasons, all reasonable at the time, we took a different path and increasingly centralized Twitter. But a lot's changed over the years." Dorsey, who is also the CEO of Square (SQ) also noted that "Square is doing exactly this for bitcoin with @sqcrypto. For social media, we'd like this team to either find an existing decentralized standard they can help move forward, or failing that, create one from scratch. That's the only direction we at Twitter, Inc. will provide." Reference Link
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AKER | Hot Stocks09:32 EST Akers Biosciences regains compliance with Nasdaq listing standards - Akers Biosciences announced that on December 10, 2019, it received notice from the Hearings Advisor of the Nasdaq Office of General Counsel that the Company successfully regained compliance with the minimum bid price requirements set forth under Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market and that the Company is in compliance with all other applicable listing standards. Therefore, the Company's scheduled hearing before the Nasdaq Hearing Panel has been cancelled and the Company's common stock will continue to be listed and trade on The Nasdaq Stock Market.
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PLPRF | Hot Stocks09:28 EST Plus Products transitions to HERBL as primary California distribution partner - Plus Products announced the transition of its primary California distribution partner from Calyx Brands to HERBL Distribution Solutions for the Company's cannabis products. "After an extensive review of the major California cannabis distributors, we determined that HERBL was best positioned to scale with PLUS and reliably deliver product to retailers at the lowest cost," said Jake Heimark, Co-founder & CEO of PLUS. "One of our goals at PLUS is to put our products on every shelf at an affordable price, and we believe HERBL is the perfect partner to help us reach that goal. Their substantial market reach and world class management team give us confidence that they will help PLUS further solidify our position as the largest cannabis-infused gummies brand in California." HERBL is a leader in the California market with active distribution to over 600 licensed retailers across the state, 240 more locations than the 360 licensed retailers in which PLUS cannabis-infused edibles are available. PLUS has an internal sales team of fifteen individuals working directly with HERBL's team to ensure a quick and efficient transition for the Company's current retail partners, and to open new accounts moving forward. PLUS, as a part of this transition, has entered into a settlement agreement with Calyx dated December 9, 2019, which addresses, among other things, the termination of the distribution arrangement between the two parties. In accordance with the terms of the settlement agreement, the Company has arranged with HERBL to take responsibility for distributing the Company's branded products inventory currently held by Calyx. Additionally, a qualified third party will assist in the collection of a portion of outstanding accounts receivable associated with the sales of PLUS branded products by Calyx. PLUS has also agreed to forbear any claims against Calyx and its parent company, Nutritional High, through June 5, 2020.
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MRMD | Hot Stocks09:25 EST Marimed to open dispensary in Middleborough, Massachusetts - MariMed received final authority from Massachusetts Cannabis Control Commission to commence RMD operations at its Panacea Wellness Dispensary in Middleborough. ARL Healthcare Inc., a wholly-owned MariMed subsidiary, plans to open two additional dispensary licenses in Massachusetts. The Panacea Wellness Dispensary in Middleborough, MA will open for medical use on December 19, 2019, at 10 AM. New Panacea patients can register directly at the state-of-the-art facility at 29 Harding St. beginning that day. The initial opening of Panacea Wellness will serve patients who hold a valid Medical Cannabis card in the state. There are over 60,000 patients enrolled in the Massachusetts medical cannabis program. The Company is expecting adult-use approval from the CCC within the next three months, pending a final inspection by the agency.
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TYHT | Hot Stocks09:21 EST Shineco signs $10M industry hemp fiber preliminary processing sales contract - Shineco announced that it signed a RMB70M, approximately $10M, industry hemp fiber preliminary processing sales contract with Chengongliao Science & Trade Co., an enterprise focusing on hemp processing in China. CSTC focus on the construction of the entire industrial hemp industry chain and it conducts business globally, covering various industries such as food, health products, and cosmetics. In addition, CSTC is constantly analyzing industry trend and industrial structure, proactively upgrade technology and product, and continuously improving the branding awareness.Pursuant to the Contract, CSTC agrees to purchase 4000 tons industry Hemp Fiber by a certain market price from the Company. The purchase amount of the Contract is up to RMB70M.
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MTBC | Hot Stocks09:19 EST MTBC announces release of telemedicine solution - MTBC announced the release of its proprietary new telemedicine solution, called talkPHR, which is designed to enable virtual patient encounters through MTBC's talkEHR.
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APDN | Hot Stocks09:18 EST Applied DNA Sciences, Old Port Oil to conduct first pilot to tag CBD oil - Applied DNA Sciences announced it will conduct a funded pre-commercial pilot to tag cannabidiol, or CBD, oil for Old Port Oil using its CertainT platform to tag, test and track the CBD oil product. Newly formed Old Port Oil, a cannabis processor company, will soon launch its first CBD product and turned to Applied DNA's CertainT platform to ensure its brand and IP protection and prove the origin of its CBD product proudly produced in Maine. Upon successful completion of the pilot project, Old Port Oil expects to ramp up commercial production in January and anticipates it will tag 100% of its inaugural product over the course of 2020.
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FOCS | Hot Stocks09:16 EST Focus Financial says Nexus Investment Management to join as partner firm - Focus Financial Partners announced that Nexus Investment Management has entered into a definitive agreement to join the Focus partnership. The transaction is expected to close in the first quarter of 2020, subject to regulatory approval and other customary closing conditions. Since 1988, Nexus has provided investment and wealth management services to high net worth individuals and families, foundations and endowments located across Canada. It has developed an integrated approach to portfolio management and wealth planning, establishing it as one of the most highly regarded firms in the Canadian independent market. This transaction continues Focus' expansion in international markets. Blair Franklin Capital Partners, a Toronto-based M&A advisory firm, served as financial advisor to Nexus for this transaction.
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PFG | Hot Stocks09:14 EST Principal Financial announces FY19 business unit revenue guidance - Sees FY19 Retirement & Income Solutions-Fee revenue $1.77B-$1.8B. Sees FY19 Retirement & Income Solutions - Spread revenue $615M-$630M. Sees FY19 Principal Global Investors revenue $1.3B-$1.33B. Sees FY19 Principal International revenue $940M-$970M. Sees FY19 Specialty Benefits revenue $2.33B-$2.34B. Sees FY19 Individual Life revenue $1.13B-$1.15B.
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BA | Hot Stocks09:12 EST Boeing falls after FAA head says 737 recertificaiton will extend into 2020 - Shares of Boeing are lower after Federal Aviation Administration chief Steve Dickson told CNBC this morning that regulators won't likely clear Boeing's 737 Max airplanes for flight until 2020. "Like I said there are a number of processes, milestones, that have to be completed. If you just do the math, it's going to extend into 2020," Dickson said in an interview. Boeing in November said it hoped the FAA would approve its redesign of the 737 Max by the end of this year and write new training standards for the plane in January. The stock is down $5.01 to $342.89 in premarket trading.
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GNBT | Hot Stocks09:12 EST Generex appoints Marvin Hausman to board of directors - Generex Biotechnology announced the appointment of Dr. Marvin S. Hausman, MD to the NuGenerex Immuno-Oncology Board of Directors. Hausman currently serves as Chairman of the Board & Chief Science and Technology Officer of Entia Biosciences, Inc.
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PRIM | Hot Stocks09:11 EST Primoris repurchases approx. 2.31M shares of common stock for $50M - Primoris Services Corporation announced that the Company has purchased 2,316,960 shares of common stock for an aggregate consideration of $50 million from Brian Pratt, a member of the Company's Board of Directors. The transaction completes the share repurchase program announced by the Company on November 4, 2019, and was funded with cash on hand. This represents approximately half of Mr. Pratt's holdings in Primoris. The repurchase agreement with Mr. Pratt contains a "standstill" covenant prohibiting Mr. Pratt from selling any additional shares of the Company's common stock through May 26, 2020. Mr. Pratt recently announced his intention to step down from the Board of the Company at the next regularly scheduled Board meeting in February 2020.
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D | Hot Stocks09:10 EST Dominion partners with Vanguard Renewables for dairy waste-to-energy projects - Dominion and Vanguard Renewables announced a more than $200M, nationwide strategic partnership to convert methane from U.S. dairy farms into clean, renewable natural gas. Multiple projects are under development in Georgia, Nevada, Colorado, New Mexico, and Utah with additional projects planned nationwide. Dominion Energy will own the projects and market the RNG, and Vanguard Renewables' subsidiary Clean Energy Investment USA dba Vanguard Renewables Ag will design, develop and operate the projects. By capturing methane from U.S. dairy farms and converting it into RNG, Dominion Energy's and Vanguard Renewables' strategic partnership will reduce annual CO2 equivalent emissions by more than 450,000 metric tons. Vanguard Renewables Ag focuses on the development and operation of dairy waste-to-energy projects that improve manure and nutrient management and produce clean energy.
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HPQ | Hot Stocks09:09 EST HP expands financing options with multi-vendor financing model - HP announced it has expanded its financing and leasing options for channel partners and customers. Through an extended partnership agreement with HPE Financial Services and a new strategic program with global finance company DLL Group, HP Integrated Financial Solutions will help accelerate and enhance the financing experience for customers and enable channel partners to grow their services-based businesses. By moving to a multi-vendor financing model with both HPEFS and DLL, HP Integrated Financial Solutions will help channel partners secure recurring revenue from their client base and offer more competitive payment options resulting in stronger customer engagement and the ability to bundle products and maximize opportunities. HP plans to extend the multi-vendor model in 2020 with the addition of new local and regional finance partners to ensure country coverage across emerging markets.
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BA... | Hot Stocks09:09 EST Fly Intel: Pre-market Movers - HIGHER: BioCryst (BCRX), up 3% after announcing it has submitted a new drug application to the FDA for approval of oral, once daily berotralstat for the prevention of hereditary angioedema attacks. UP AFTER EARNINGS: Photronics (PLAB), up 7%... Ollie's Bargain Outlet (OLLI), up 9%. DOWN AFTER EARNINGS: GameStop (GME), down 17%... American Eagle (AEO), down 7%... Children's Place (PLCE), down 16%... United Natural Foods (UNFI), down 10%. ALSO LOWER: Home Depot (HD), down 1% after providing its preliminary outlook for fiscal year 2020... Boeing (BA), down 1% after FAA chief Steve Dickson told CNBC this morning that regulators won't likely clear Boeing's 737 Max airplanes for flight until 2020... Iterum Therapeutics (ITRM), down 45% after results from its Sulopenem for Resistant Enterobacteriaceae, or SURE, 3 clinical trial in complicated intra-abdominal infections. The trial missed its primary endpoint of clinical response on Day 28 in the micro-MITT population... Madrigal Pharmaceuticals (MDGL), down 11% after 1.2M share spot secondary priced at $107.85 per share... Correvio (CORV), down 59% after an FDA Advisory Committee yesterday voted 11-2 against recommending approval of Brinavess for the rapid conversion of recent onset atrial fibrillation.
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PFG | Hot Stocks09:08 EST Principal Financial announces long-term targets - Sees 9%-12% annual growth in non-GAAP operating earnings and non-GAAP operating earnings per diluted share. Sees 15%-17% long-term targeted return on equity, excluding accumulated other comprehensive income other than foreign currency translation and targeted free cash flow of 70%-80% of net income each year, in excess of capital used to fund organic growth.
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WSTG | Hot Stocks09:06 EST Wayside Technology appoints Ross Crane to board of directors - Wayside Technology Group announces the appointment of Ross Crane to the Board of Directors effective December 11, 2019. With the appointment of Crane, Wayside's Board consists of six directors, all of whom are independent under the listing standards of NASDAQ and four of whom have been appointed in the past two years. From 2011 to 2019, he served as Executive Vice President, Chief Financial Officer for Nexeo Solutions.
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PHG | Hot Stocks09:05 EST Philips, Health First announce outcomes of 15-year tele-critical partnership - Royal Philips and Florida-based Health First announced the outcomes of their 15-year tele-critical partnership. Powered by Philips' acute telehealth platform eCareManager, Health First's VitalWatch eICU has demonstrated significant reductions in mortality and lengths of stay for the health system's sickest patient population. Leveraging eCareManager to synthesize patient data for actionable insights to support proactive care, Health First has created a centralized hub for patient care across venues beyond the ICU. Health First became Florida's first tele-ICU when the organization went live with VitalWatch in September 2004 and remains the only tele-ICU hub in Central Florida today. VitalWatch allows Health First's critical care physicians and nurses to monitor real-time vital signs, laboratory results, and patients' complete electronic medical records from a central location across 102 ICU beds at the four Health First hospitals. The VitalWatch staff can also direct a patient's care on the spot via live audio and video connections to the patient's room if needed. To date, the VitalWatch eICU program has resulted in: 23 percent reduction in overall mortality across the four hospitals as a whole; 49 percent reduction in ICU length of stay; and 35 percent reduction in lengths of stay throughout the four hospitals. VitalWatch monitors more than 10,000 patients each year. Annually, this vigilance has resulted in 48,000 interventions by eICU intensivists and registered nurses. Additionally, these teams have conducted more than 370,000 telemedicine assessments and managed 62,000 calls from bedside teams seeking to collaborate on patient care.
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BAC | Hot Stocks09:04 EST Bank of America CEO says Q4 investment banking revenue up 3%-4% y/y
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BAC | Hot Stocks09:04 EST Bank of America CEO says Q4 trading up 7%-8% y/y, led by FICC - Comments taken from the Goldman Sachs U.S. Financial Services Conference.
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MXCYY | Hot Stocks09:04 EST Metso to discontinue rubber, poly-met wear parts manufacturing in Ersmark - Metso continues to develop the global supply footprint in its Minerals Consumables business area by evaluating manufacturing capabilities in the EMEA region. As part of the initiative, the personnel negotiations concerning rubber and poly-met manufacturing operations in Sweden have resulted in a decision to discontinue the manufacturing in Ersmark, Sweden. The negotiations were announced in September. The decision affects approximately 150 manufacturing related positions in Ersmark. Manufacturing operations in Ersmark will be ramped down in stages from the beginning of Q2 2020 with full closure expected in Q3 2020.
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YMAB | Hot Stocks09:03 EST Y-mAbs Therapeutics announces naxitamab frontline data - Y-mAbs Therapeutics announced that positive frontline data for naxitamab will be presented at the Company's R&D event, which takes place in New York City today at 12 p.m. Eastern. Key opinion leaders, including Dr. Shakeel Modak, M.D., MRCP and Dr. Kim Kramer, M.D., both from Memorial Sloan Kettering Cancer Center and Dr. Jaume Mora, M.D., Ph.D. from SJD Barcelona Children's Hospital, will discuss the current treatment landscape and unmet medical needs for high-risk neuroblastoma and other solid tumors. Dr. Mora, who has experience treating frontline neuroblastoma patients with both naxitamab and a competing anti-GD2 antibody, will present clinical data from both antibodies. Data from an investigator sponsored frontline study of 34 patients with high-risk stage 4 neuroblastoma in first complete remission showed a 72% event free survival at 24 months for naxitamab patients, which compared favorably to the 63% reported at 24 months for a population of 89 patients treated with a competing anti-GD2 antibody. In addition, it was noted that only 20% of the patients treated with naxitamab received bone marrow transplant, as was the case for all patients treated with the competing anti-GD2 antibody. In terms of overall survival, the naxitamab patients achieved an 86% OS at 24 months, compared to 84% OS for the competing anti-GD2 antibody. The naxitamab treatment was well-tolerated, and the infusion related pain generally associated with anti-GD2 antibodies required significantly less opioids for naxitamab than for the competing anti-GD2 antibody. The use of morphica generally declined significantly after the first treatment cycle, and naxitamab required less than 15% of the morphine dose required by the competing anti-GD2 antibody. A second frontline study with naxitamab is currently ongoing at MSK in New York City, and Y-mAbs expects data from this study to be published in the first half of 2020. Y-mAbs is also planning a multicenter frontline study, which we expect to initiate in 2020.
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NUE | Hot Stocks09:02 EST Nucor to acquire TrueCore, terms not disclosed - Nucor announced that it is acquiring TrueCore, an insulated metal panel manufacturing company with a facility in Laurens, South Carolina. TrueCore produces insulated metal panels serving the cold storage market, with future plans for additional commercial and industrial applications. TrueCore currently has 26 employees and will become part of Nucor Buildings Group.
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DD | Hot Stocks09:01 EST DuPont to acquire Desalitech, terms not disclosed - DuPont announced it has signed an agreement to acquire Desalitech, a closed circuit reverse osmosis company. The transaction is expected to close in January 2020, subject to customary closing conditions and regulatory approvals. Financial terms of the agreement were not disclosed.
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CCBG | Hot Stocks08:51 EST Capital City Bank to acquire 51% of BrandMortgage, terms not disclosed - Capital City Bank announced its entry into a definitive agreement with BrandMortgage, whereby CCB will acquire 51% ownership of BrandMortgage. This strategic alliance reflects a shared commitment by both companies to deliver the highest quality mortgage services and expertise to homebuyers throughout the Southeast. Following the closing, mortgage services will be offered under the name of Capital City Home Loans. The alliance between Capital City Bank and BrandMortgage represents a combined 140 years in business and offers the advantage of expanded service areas, a wider array of products and options to meet the needs of homebuyers in all stages of life, and increased lending capacity through additional processing hubs and investors. Uniting the two companies' footprints will add 21 mortgage production offices to Capital City Bank's 57 full-service banking offices and will expand the availability of mortgage services throughout the Southeast. If the transaction had been completed in 2019, the mortgage volume of the combined operations would have been approximately triple CCB's historical level. Established in 1895 and headquartered in Tallahassee, Fla., Capital City Bank is a subsidiary of Capital City Bank Group and provides full banking and financial management services in 26 counties in Florida, Georgia and Alabama. BrandMortgage is headquartered in Lawrenceville, Ga. and is led by CEO and Managing Partner Greg Shumate and President and Managing Partner Alex Koutouzis. They currently provide mortgage services in Alabama, Georgia, Florida, Maryland, Mississippi, North Carolina, South Carolina, Tennessee, Virginia and Washington D.C. Under the terms of the definitive agreement, Shumate will be elected as an officer of Capital City Bank, and BrandMortgage will continue to operate independently from its headquarters in Lawrenceville, Ga. under the leadership of Shumate and Koutouzis. The financial terms of the transaction were not disclosed. The definitive agreement has been unanimously approved by the boards of directors of Capital City Bank and BrandMortgage. Completion of the transaction is subject to customary closing conditions, including receipt of required regulatory approvals, and is expected to close in the first quarter of 2020.
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OLN | Hot Stocks08:46 EST Olin shutting down two facilities in Freeport, Texas - Olin plans to permanently shut down a chlor alkali plant with a capacity of 230,000 tons and its Vinylidene Chloride production facility, both in Freeport, Texas. These closures are expected to be completed before the end of 2020. When completed, these actions are forecast to reduce Olin's annual operating costs by approximately $35M. Olin's Q4 results will contain approximately $65M of pretax non-cash restructuring charges, representing asset impairment charges, associated with these plans.
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GE | Hot Stocks08:43 EST General Electric, Agilyx announce collaboration in artificial intelligence - Agilyx announced a dynamic collaboration in artificial intelligence technology with the General Electric Company through its licensing business unit. Combining Agilyx's deep domain experience in chemical recycling with GE's vast experience in the application of Industrial AI, the two companies are aiming to increase the chemical recyclability of all post-use plastics from the current 10% to over 95%.
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CPST | Hot Stocks08:43 EST Capstone Turbine announces nine-year FPP contract with Distributed Generation - Capstone Turbine announced that E-Finity Distributed Generation, Capstone's exclusive distributor for the Mid-Atlantic, Southeastern United States and the Caribbean, signed a long-term factory protection plan, or FPP, service contract covering Capstone's single largest combined heat and power, or CHP, installation with five megawatts of Capstone Microturbines. The five new Signature Series C1000's are commonly ducted together to inject the turbines' exhaust thermal energy directly into a drying process for a large ceramic tile manufacturer in the United States. This nine-year FPP will provide service coverage, including engine overhauls, as well as all scheduled and unscheduled maintenance at a fixed cost for the entire nine-year term. The Capstone microturbines, commissioned in late October, are used for 24x7 electrical and thermal generation and are configured with Capstone dual-mode technology that will "island" the power plant and provide back-up electrical and thermal power to plant operations in the event of a local grid power outage.
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MATN | Hot Stocks08:39 EST Mateon Therapeutics establishes EdgePoint AI division - Mateon Therapeutics announced that they have established EdgePoint AI, as a division within Mateon, to develop and commercialize Mateon's AI Vision Fabric for pharmaceutical manufacturing. EdgePoint AI will have exclusive rights to the Mateon AI Fabric technologies, including patents, knowhow, and Mateon AI Vision related to pharmaceutical development and manufacturing. The platform will be known as TrustPoint AI Vision Fabric. The Company expects to spin off EdgePoint AI in the near future as a dividend to Mateon shareholders. The TrustPoint technology, is trained to automatically perform routine inspections that verify manual data documentation and digitally document the transfer/status change of materials using processes established by the manufacturer. The TrustPoint System with its machine vision AI functions will automate current manual entry processes while working within the manufacturer's quality systems. The technology is expected to streamline manufacturing operations resulting in substantial manufacturing cost reductions while maintaining compliance. The machine generated data from TrustPoint will be stored in a blockchain ledger, to ensure data integrity, immutability and auditability. The platform has broad application potential across virtually all types of pharmaceutical manufacturing including biologics, cell and gene therapy, small molecule manufacturing, bulk drug substance, fill finish, packaging and labeling. This technology is already employed in the retail sector for tracking customer purchases and in the Transportation industry to monitor and detect potential failure points. The goal of EdgePoint is to apply machine Vision AI technology in pharmaceutical manufacturing whether it is in house manufacturing or outsourced contract manufacturing organization/contract development and manufacturing organization facilities.
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FTV... | Hot Stocks08:38 EST Fortive appoints Mark Morelli as CEO, David Naemura as CFO of NewCo - Fortive (FTV) announced the appointments of Mark Morelli as President & CEO and David Naemura as CFO of NewCo, a global industrial company that Fortive previously announced it will form as part of its planned separation into two independent, publicly traded companies. Both Morelli and Naemura will assume their respective roles with NewCo in the first quarter of 2020. Fortive also announced its intention to appoint Karen Francis as the Chair of the Board of Directors of NewCo immediately prior to NewCo becoming a public company. Fortive continues to expect to complete the separation in the second half of 2020. Morelli was most recently CEO of Columbus McKinnon (CMCO). Naemura was most recently CFO of Gates Industrial (GTES).
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MYSZ | Hot Stocks08:37 EST MySize's smart measurement software reduces costs for DeMoulin - My Size reports it has "significantly reduced" DeMoulin's measurement-related costs, including shipping and returns, following the launch of the MySizeID smart measurement solution software development kit on DeMoulin's smartphone application in July 2019. DeMoulin is the oldest and largest manufacturer of music performance group apparel in the world. According to DeMoulin, incorporation of MySizeID into its smartphone app, has yielded "strong results and significant cost savings".
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GILD KNSA | Hot Stocks08:36 EST Gilead, Kiniksa announce collaboration on Phase 2 mavrilimumab study - Kite, a Gilead company (GILD), and Kiniksa (KNSA) announced that the companies have entered into a clinical collaboration to conduct a Phase 2, multicenter study of mavrilimumab, an investigational fully human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha, or GM-CSFRa, in combination with Yescarta in patients with relapsed or refractory large B-cell lymphoma. The objective of the study is to determine the effect of mavrilimumab on the safety of Yescarta. Kite will be the sponsor of this study and will be responsible for its conduct. Treatment related induction of GM-CSF has been identified through clinical, translational and preclinical studies as a potential key signal associated with side effects of chimeric antigen receptor T, or CAR T, cell therapy. Preclinical evidence shows the potential for interruption of GM-CSF signaling to disrupt CAR T cell mediated inflammation without disrupting anti-tumor efficacy.
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CMCO FTV | Hot Stocks08:35 EST Columbus McKinnon CEO Mark Morelli to depart to become CEO of Fortiv NewCo - Columbus McKinnon (CMCO) announced that Mark Morelli has informed the board of his intention to resign from his position as President, CEO and Director effective January 10, 2020 to accept the position of President and CEO of Fortive's NewCo. Mr. Morelli will continue in his capacity to transition his responsibilities over the next 30 days. Richard Fleming, Columbus McKinnon's Chairman of the board, will be named Interim CEO effective with Mr. Morelli's resignation. The board has initiated a search process for a new CEO.
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ATXI | Hot Stocks08:34 EST Avenue Therapeutics announces NDA submission for IV tramadol - Avenue Therapeutics announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for IV tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting. The NDA for IV tramadol is based on positive results from two pivotal Phase 3 clinical efficacy and safety trials in patients following bunionectomy and abdominoplasty surgeries, as well as an open-label safety study with a total of more than 500 patients who received the IV tramadol 50 mg dosing regimen. In addition, the NDA includes an epidemiology study on abuse of tramadol in the U.S. and in certain European countries where IV tramadol is available. The study finds that reports of abuse with tramadol are infrequent, both in absolute number and relative to other prescription opioids, and that abuse of tramadol via injection is uncommon relative to oral tramadol in countries where it is available.
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IDEX | Hot Stocks08:34 EST Ideanomics signs exclusive partnership with Chinese truck management platform - Ideanomics announced a strategic partnership with Linghao Zhitong 3000, an SaaS platform for shipping and logistics management in China. Ideanomics' Mobile Energy Global - or MEG - division will be the exclusive agent for truck purchasing and leasing services to Linghao Zhitong 3000's customer base, which is currently more than 230,000 trucks from over 1,000 fleet operators. Current growth forecasts for Linghao Zhitong extend that number of trucks to 300,000 for 2020 and reaching 500,000 by 2023. MEG will also provide procurement and leasing services to the long-distance market which EV does not currently support, until such time as charging network infrastructure and/or EV battery technology can support the longer distance truck operators. As part of the agreement, MEG and Linghao Zhitong will explore other business opportunities, including a lease financing consortium, insurance product solutions, fractionalized ownership programs, as well as the potential for a capital markets partnership.
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KNSA GILD | Hot Stocks08:33 EST Kiniksa, Kite announce collaboration for study of mavrilimumab w/ Yescarta - Kite, a Gilead Company (GILD), and Kiniksa Pharmaceuticals, Ltd. (KNSA) announced that the companies have entered into a clinical collaboration to conduct a Phase 2, multicenter study of mavrilimumab, an investigational fully human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha, in combination with Yescarta in patients with relapsed or refractory large B-cell lymphoma. The objective of the study is to determine the effect of mavrilimumab on the safety of Yescarta. Kite will be the sponsor of this study and will be responsible for its conduct. Treatment related induction of GM-CSF has been identified through clinical, translational and preclinical studies as a potential key signal associated with side effects of chimeric antigen receptor T cell therapy. Preclinical evidence shows the potential for interruption of GM-CSF signaling to disrupt CAR T cell mediated inflammation without disrupting anti-tumor efficacy. Yescarta was the first CAR T cell therapy to be approved by the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Mavrilimumab, alone or in combination with other therapies such as Yescarta, is investigational and has not been approved by the FDA or any regulatory authority for any uses. Efficacy and safety have not been established.
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GTES | Hot Stocks08:27 EST Gates Industrial CFO David Naemura departing, interim CFO appointed - Gates Industrial CFO David Naemura will depart the company effective January 31st, 2020. Naemura is leaving to become the CFO of a new company to be formed by Fortive in association with its planned separation into two independent publicly traded companies. David Wisniewski, Senior VP and Chief Accounting Officer, will assume the responsibility of interim CFO while the company conducts its search for a new CFO. Wisniewski joined Gates in April of 2018. Prior to joining Gates, he held roles of increasing responsibility in the finance and accounting functions at General Motors Company, most recently as Global Business Services CFO, and was previously a partner at Ernst & Young.
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PMBC | Hot Stocks08:19 EST Pacific Mercantile Bank provides financing to Mako Steel - Pacific Mercantile Bank announced that it has provided a credit facility to Mako Steel. The credit facility supplements the recent investment in Mako Steel made by New State Capital Partners, as well as provides for ongoing working capital needs. In addition to the financing, Mako Steel utilizes a full suite of Pacific Mercantile Bank's depository products and treasury management services. Founded in 1993, Mako Steel designs, supplies, and installs steel buildings for the self-storage industry.
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DARE | Hot Stocks08:15 EST Dare announces alignment with FDA on Phase 2b study of Sildenafil Cream - Dare Biosciences announced the outcome of a Type C meeting with the U.S. Food and Drug Administration where alignment was reached on the patient reported outcome instruments to be used in a Phase 2b clinical study of Sildenafil Cream, 3.6% to screen eligible patients with Female Sexual Arousal Disorder and to assess the efficacy of Sildenafil Cream in treating FSAD. The discussions with the FDA followed the completion of a content validity study of the proposed PRO instruments, a non-interventional study integral to initiating the at-home, product dosing portion of the Sildenafil Cream Phase 2b program. Of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction in men and is characterized primarily by an inability to attain or maintain sufficient genital arousal during sexual activity that causes distress or interpersonal difficulty. Despite several approved prescription products for ED, no pharmacologic options have yet been approved by the FDA for FSAD. Sildenafil, the active ingredient in Sildenafil Cream, is marketed in an oral dosage form under the brand name Viagra for the treatment of ED in men. Sildenafil Cream is a proprietary cream formulation of sildenafil specifically designed to increase blood flow to the genital tissue in women, leading to a potential improvement in genital arousal response during sexual activity. If successful in clinical studies, Sildenafil Cream has the potential to be the first FDA-approved pharmacologic treatment option for FSAD. In a Phase 2a trial, Sildenafil Cream increased measurable blood flow to the vaginal tissue in both pre- and post-menopausal women with FSAD compared to placebo cream. Further, data from a thermography study in healthy women demonstrated significantly greater increases in genital temperature after administration of Sildenafil Cream compared to after administration of placebo cream and no cream at all, indicating a positive impact on genital blood flow during the 30-minute testing session.As part of the Type C process, Dare and SST also confirmed with the FDA that no additional nonclinical or clinical data are required before initiating the Phase 2b at-home study. The companies also reviewed with the FDA what other data would be required to support a future New Drug Application submission, including additional nonclinical and clinical studies that may need to be completed before NDA submission. Dare and SST will continue to actively engage with the FDA in 2020 to help ensure any required studies and activities are completed over the balance of the development program to support an NDA submission that will be complete for review. The companies intend to initiate the Phase 2b at-home study in 2020. The Phase 2b is designed to evaluate Sildenafil Cream versus placebo over twelve weeks of dosing following both a non-drug and placebo run-in period.
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CSTM | Hot Stocks08:11 EST Constellium's Singen facility to offer ASI certified aluminum rolled solutions - Constellium SE announced that its casting and rolling operations in Singen, Germany, were granted the Chain of Custody certification by the Aluminium Stewardship Initiative. Singen previously received ASI's Performance Standard certificate, which ensures that the plant operates according to a strict set of governance, environmental, and social standards. Certification against both ASI standards means that Singen has the capability, combined with the sourcing of ASI metal, to supply to its customers independently certified, responsibly sourced and sustainably manufactured aluminium rolled solutions. Constellium continues to work to achieve ASI certification of other facilities. The company also collaborates with its key metal suppliers to support them in the certification journey, to be well positioned to offer more ASI certified products to its customers, and to promote the overall sustainability of the aluminum market.
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MLSS | Hot Stocks08:10 EST Milestone Scientific partners with RedOne Medical to distribute CompuFlo - Milestone Scientific announced that it has partnered with RedOne Medical, a medical device distributor and wholesaler serving the Department of Veterans Affairs, or VA, medical centers and Department of Defense, or DoD, hospitals, to distribute the CompuFlo Epidural System.
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AEO | Hot Stocks08:08 EST American Eagle down 7.6% after reporting Q3 results, giving Q4 guidance
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MD | Hot Stocks08:08 EST Mednax says 'welcomes constructive dialogue' with Starboard Value - In a regulatory filing, Mednax said it is "aware" that Starboard Value and Opportunity Master Fund Ltd has made an investment in the company and has met with Starboard as a new shareholder. Starboard has submitted nominations for a majority slate of directors at the company's 2020 Annual Meeting of Shareholders. Mednax said "The company's Board of Directors and leadership team value the views of all of the company's shareholders and welcome a constructive dialogue with Starboard."
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AZN | Hot Stocks08:08 EST AstraZeneca says 60.9% tumor response rate seen in trastuzumab deruxtecan trial - AstraZeneca and Daiichi Sankyo presented detailed data from the global pivotal Phase II single-arm DESTINY-Breast01 trial of trastuzumab deruxtecan, a HER2-targeting antibody drug conjugate and potential new medicine, in patients with HER2-positive metastatic breast cancer who received two or more prior HER2-targeted regimens. The primary endpoint of objective response rate, confirmed by independent central review, was 60.9% with trastuzumab deruxtecan monotherapy. Patients had a median of six prior therapies for metastatic disease. Patients achieved a disease control rate of 97.3% with a median duration of response of 14.8 months and median progression-free survival of 16.4 months. The median overall survival has not yet been reached, with an estimated survival rate of 86% at one year. The results were consistent across subgroups of patients. Jose Baselga, Executive Vice President, Oncology R&D, said: "The clinically meaningful and durable responses seen among these patients illustrate the potential of trastuzumab deruxtecan to establish a new standard of care. These results are impressive, as women with this advanced stage of breast cancer have already endured multiple prior therapies for HER2-positive metastatic breast cancer."
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DLTR | Hot Stocks08:07 EST Dollar Tree promotes Richard McNeely to CMO, Thomas O'Boyle to COO - Dollar Tree announced changes to its organizational structure and leadership team. These changes, effective immediately, follow the recently completed consolidation of the organization's two store support centers to the company's corporate office in Chesapeake, Virginia. Michael Witynski has been promoted to enterprise president of Dollar Tree and will lead the merchandising, store operations, and supply chain functions for the Dollar Tree and Family Dollar business segments. His principal focus will be on improving enterprise-wide operational efficiency and reducing distribution costs across both store brands. Richard McNeely has been promoted to chief merchandising officer, or CMO, of Dollar Tree and will lead the merchandising, marketing, and global sourcing functions for the Dollar Tree and Family Dollar business segments. His primary focus will be on improving enterprise-wide merchandising margins while improving value for the customer. Thomas O'Boyle has been promoted to COO of Dollar Tree, and will lead the store operations and real estate functions for the Dollar Tree and Family Dollar business segments. Among other things, he will be focused on optimizing real estate, improving customer experience and addressing recent issues around inventory shrink.
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VRA | Hot Stocks08:06 EST Vera Bradley expects to return to positive comparable sales growth this year - "In fiscal 2019, the first stage of Vision 20/20 was to restore brand and Company health. We have continued to build upon that progress in fiscal 2020. During the first nine months of this year, we once again improved the quality of sales in our full-line stores and on verabradley.com by increasing comparable full price selling in these two channels by approximately 7%. This is on top of a nearly 20 percent increase in the first nine months of last year. As we complete Year Two of our three-year journey, we remain steadfastly focused on growing our customer base, sales, and profitability," CEO Wallstrom concluded. "As a reminder, our key areas of focus for Fiscal 2020 are: Growth: Our plan is to return to positive comparable sales growth this year, and through the first nine months, Vera Bradley comparable sales were up 3.8%, in line with our expectations. Even in the face of a challenging North American handbag market, our improvement is being driven by exciting, innovative product, supported by data-driven marketing and a relentless focus on customer engagement and the consumer experience. Vera Bradley customer count is up double digits year-over-year. The acquisition of Pura Vida is adding to our growth as well. Operational Excellence: Mid-year, we began a two-year process of re-platforming our ERP and other key information systems to become more streamlined, nimble, and efficient in our technology and business processes. We have also successfully focused on mitigating the impact of increased tariffs. Ownership: We are reinforcing our unique culture as an ownership-based model, where every Associate can drive significant value creation through both individual and team efforts."
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CUZ TFC | Hot Stocks08:06 EST Cousins Properties sells Charlotte office tower to Truist Financial for $455.5M - Cousins Properties (CUZ) has sold Hearst Tower in Uptown Charlotte to Truist Financial, a merger between BB&T (TFC) and SunTrust, for $455.5M. The building will serve as Truist's headquarters. The transaction is expected to close in March 2020.
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ONCT | Hot Stocks08:05 EST Oncternal announces opening of Phase 1b expansion cohort of TK216 clinical trial - Oncternal Therapeutics announced that it has opened for enrollment a Phase 1b expansion cohort of its ongoing clinical trial evaluating TK216, a first-in-class, targeted, investigational small-molecule inhibitor of the E26 transformation-specific, or ETS, family of oncoproteins, in patients with relapsed or refractory Ewing sarcoma. "The decision to open an expansion cohort was based on favorable interim results from the dose-finding cohort of the trial, including a deep and sustained clinical response reported for one of the patients treated at the current, highest exposure dose regimen, who is without evidence of Ewing sarcoma after more than eight months on study and has tolerated treatments with TK216, alone and in combination with vincristine, well. TK216 has been generally well tolerated in this trial. Dose limiting toxicities consisted of transient and manageable myelosuppression, primarily neutropenia." The expansion cohort will further evaluate the recommended Phase 2 dose regimen of TK216 in combination with vincristine and is anticipated to enroll approximately 18 patients with relapsed or refractory Ewing sarcoma.
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LM | Hot Stocks08:04 EST Legg Mason reports preliminary AUM $790.5B as of November 30 - This month's AUM included long-term net outflows of $2.2B, driven by fixed income net outflows of $1.5B and equity net outflows of $1.1B, partially offset by alternative net inflows of $0.4B. Realizations totaled $0.2B. AUM also included liquidity net outflows of $2.2B and negative foreign exchange of $1.7B.
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DBX | Hot Stocks08:04 EST Dropbox says Yamini Rangan to step down as chief customer officer - In a regulatory filing, Dropbox announced that on December 10, Yamini Rangan decided to step down as Chief Customer Officer. Rangan will remain at Dropbox to help with the transition until January 3, 2020. Rangan will receive a transition payment of $500,000. Quentin Clark, whose decision to step down was previously announced in a regulatory filing with his last day at the company January 3, 2020, will also receive a transition payment of $500,000. Both Rangan and Clark will execute a general release of claims in favor of Dropbox and its affiliates containing customary non-disparagement covenants.
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COTY | Hot Stocks08:03 EST Coty appoints Pascal Baltussen as Chief Global Chief Procurement Officer - Coty announced the appointment of Pascal Baltussen as Global Chief Procurement Officer and a member of Coty's Executive Committee. Effective January 1, Pascal will report to Pierre Laubies, CEO, and will be based in Amsterdam. This follows the appointment of Richard Jones as Global Chief Supply Officer on November 1. Pascal spent the last nine years with Mars.
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KR WBA | Hot Stocks08:03 EST Kroger and Walgreens form group purchasing organization - Kroger (KR) and Walgreens (WBA) have formed a new group purchasing organization aimed at delivering purchasing efficiencies, lower costs and combined resources. The new joint venture will be called Retail Procurement Alliance. Kroger and Walgreens initially announced an exploratory pilot in October 2018 to develop a one-stop shopping experience, which launched in December 2018 as the Kroger Express concept in 13 Walgreens stores in Northern Kentucky.
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CORV | Hot Stocks08:02 EST Correvio announces plans to explore strategic options - Correvio announced plans to explore strategic options to maximize stakeholder value. Potential strategic alternatives that may be evaluated include, but are not limited to, an acquisition, merger, business combination or other strategic transaction involving the company or its assets. "Given yesterday's FDA's Cardiovascular and Renal Drugs Advisory Committee meeting outcome for Brinavess for the conversion of atrial fibrillation, we believe it is in the best interest of our stakeholders to expand our internal corporate development efforts and formally evaluate strategic alternatives for the company," said Mark H.N. Corrigan, MD, CEO of Correvio. "We have a strong and growing commercial portfolio of assets being sold across the globe and we will immediately begin preparations for a potential strategic transaction while we await the U.S. FDA's decision regarding Brinavess. We are also taking steps to reduce operating costs outside the core European commercial business and a transaction committee has been formed within the Board of Directors." To conserve its financial resources, Correvio intends to reduce its operating costs in North America, while concentrating its resources on only essential commercial and business development activities. Correvio has retained Piper Jaffray to assist in its review of strategic alternatives.
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NVLN | Hot Stocks07:48 EST Novelion Therapeutics provides update on effective date of liquidation - Novelion Therapeutics announced that a hearing date has not yet been scheduled for consideration of the Company's application materials, filed on November 18, 2019 with the Supreme Court of British Columbia, relating to Court orders sought by the Company in connection with the Company's voluntary liquidation and dissolution. As previously announced, the Company expects that such hearing date, once assigned, will also serve as the effective date of commencement of the Liquidation. The Company intends to publicly announce the date of the hearing as promptly as practicable after such date is received.
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GORO | Hot Stocks07:46 EST Gold Resource announces expansion of Mirador Mine - Gold Resource Corporation announced the expansion of its Mirador Mine with fifteen exploration drill hole results from its 2019 Alta Gracia projects drill program located at its Oaxaca Mining Unit, Mexico. Highlights include 3.72 meters grading 1.44 grams per tonne gold and 990 g/t silver, including 1.00 meter grading 2.84 g/t gold and 2,610 g/t silver in a step down hole to known mineralization. Gold Resource Corporation is a gold and silver producer, developer and explorer with operations in Oaxaca, Mexico and Nevada, USA. The Company has returned $112 million to its shareholders in monthly dividends since commercial production commenced July 1, 2010 and offers its shareholders the option to convert their cash dividends into physical gold and silver and take delivery. The Alta Gracia Project, which hosts the Mirador Mine, is located approximately sixteen kilometers north west of the Company's Aguila Project and mineral processing plant. High-grade Mirador ore is trucked to the Aguila mill for processing. The 2019 Alta Gracia drill campaign tested several step-out and in-fill target areas focused primarily on the Mirador mine's Independencia West vein. In March 2019 the Company announced Mirador mine development crosscut six meters of the Independencia vein which graded 992 g/t silver. The goal of this latest drill campaign was to test the extensions of this high-grade ore shoot.
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UNFI | Hot Stocks07:40 EST United Natural Foods down 10% to $8.85 after mixed Q1 results, FY20 guidance
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PAAS | Hot Stocks07:40 EST Pan American Silver reports initial mineral resource at La Colorada mine - Pan American Silver reported an initial mineral resource estimate for the large polymetallic deposit discovered in 2018 at the company's La Colorada mine in Zacatecas, Mexico. The inferred mineral resource totals 72.5 million tons, averaging 44 grams per ton of silver, 0.17% copper, 2.02% lead and 4.40% zinc, assuming a cut off value of $60 per ton after accounting for transportation, smelting and refining costs. The deposit remains open in nearly all directions for resource expansions. The majority of the mineralization is contained within a larger polymetallic mineralized skarn covering an area measuring 500 metres by 600 metres. In 2020, Pan American plans to invest $10M to drill 44,000 metres, focusing on infill and exploration drilling to further define, expand and add confidence to the inferred resource.
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ETFC | Hot Stocks07:37 EST E-Trade reports November DARTs up 32% y/y - E-Trade released its monthly activity report for November. Daily Average Revenue Trades, or DARTs, for November were 354,434, a 22% increase from October and a 32% increase from the year-ago period. Derivatives represented 33% of DARTs during the month.
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AAXN | Hot Stocks07:35 EST Axon's Body 2 cameras selected by Corrective Services New South Wales - Axon subsidiary Axon Public Safety Australia announced that the Corrective Services New South Wales is deploying 336 Axon Body 2 cameras backed by the digital evidence management system Axon Evidence. The This order was received in Q3 and is shipping now. Corrective Services NSW is deploying Axon technology to officers following a nine-month proof of concept.
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ARWR | Hot Stocks07:34 EST Arrowhead files IND for Phase 1b study of ARO-HIF2 for treatment of ccRCC - Arrowhead Pharmaceuticals announced that it has submitted an Investigational New Drug, or IND, application to the FDA for a Phase 1b adaptive dose-finding clinical study of ARO-HIF2, the company's investigational RNA interference, or RNAi, therapeutic being developed as a treatment for patients with clear cell renal cell carcinoma, or ccRCC. Javier San Martin, M.D., chief medical officer at Arrowhead, said: "ARO-HIF2 is Arrowhead's first TRiM enabled investigational RNAi therapeutic to target a cell type outside of the liver. Clear cell renal cell carcinoma, or ccRCC, is one of the most common forms of kidney cancer. Most patients with ccRCC have a mutation in the Von Hippel-Lindau gene, rendering them unable to degrade HIF-2alpha, which leads to accumulation during tumor hypoxia and promotes tumor growth. We believe this makes HIF-2alpha an attractive target for an RNAi-based intervention." Pending regulatory review, the company intends to initiate AROHIF21001, a Phase 1b adaptive design dose-finding clinical study in patients with advanced ccRCC to evaluate the safety of ARO-HIF2 and to determine the recommended Phase 2 dose. Additional secondary objectives include the assessment of pharmacokinetics and efficacy, based on Response Evaluation Criteria in Solid Tumors. An exploratory objective for AROHIF21001 will be gene target knockdown using tumor biopsy.
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NTEC NVS | Hot Stocks07:33 EST Novartis terminates Accordion Pill development agreement with Intec Pharma - Novartis (NVS) has terminated the Feasibility and Option agreement with Intec Pharma (NTEC) for the development of a custom-designed Accordion Pill, or AP, for a proprietary Novartis compound, despite the AP having met the technical and pharmacokinetic clinical specifications set forth by Novartis. Novartis, following an internal and revised commercial strategic assessment, advised Intec that this program no longer meets Novartis' mid to long-term strategic goals. Novartis agreed to pay Intec Pharma $1.5M on conclusion of the program. Under the terms of the agreement, the drug and therapeutic area were not disclosed. The company is in the process of restructuring the clinical manufacturing planned to support this program in order to reduce costs.
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BLCM | Hot Stocks07:32 EST Bellicum Pharmaceuticals licenses CaspaCIDe Safety Switch to MD Anderson - Bellicum Pharmaceuticals announced that The University of Texas MD Anderson Cancer Center exercised its option to license Bellicum's CaspaCIDe safety switch technology. Under terms of the original license agreement, MD Anderson's decision to exercise the option entitled Bellicum to receive an upfront payment of $5M, to be recognized in the fourth quarter 2019 financial results, and undisclosed future milestone payments and royalties on sales. The license agreement with Bellicum specifically covers use of the CaspaCIDe safety switch in MD Anderson's CD19-directed chimeric antigen receptor natural killer cell construct.
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PLCE | Hot Stocks07:29 EST Children's Place down 17% to $58.20 after lowering FY19 guidance - The company's Q4 outlook also trailed estimates.
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IAG | Hot Stocks07:16 EST IAMGold increases interest in Nelligan project by 24% for C$2.35M - Vanstar Mining Resources announced that IAMGOLD Corporation, their strategic partner in the development of the Nelligan project, exercised in advance its option to increase its undivided interest in the Nelligan project by 24% to now hold a 75% interest in the property. Vanstar retains a 25% interest and 1% NSR in the original claims. Under the terms of the amended agreement of February 2018, IAMGOLD has fulfilled all the required conditions by delivering a first NI43-101 estimate of mineral resources and by doing the remaining cash payment of C$2.35M. IAMGOLD can earn an additional 5% interest by delivering a feasibility study. The Nelligan project is located in the Chapais-Chibougameau region and consists of 158 claims within an area of 8,216 hectares. It is accessible all year long by different forest roads. The project hosts mineral resources consisting of inferred resources limited by a pit, totaling 96,990,000 MT at an average grade of 1.02 grams of gold per ton for 3,193,000 ounces of gold.
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PRQR | Hot Stocks07:13 EST ProQR Therapeutics doses first patient in Phase 1/2 Aurora trial of QR-1123 - ProQR Therapeutics announced the first patient dosed in the Phase 1/2 Aurora clinical trial of QR-1123 in patients with autosomal dominant retinitis pigmentosa. Initial data from the study are expected in 2021.
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BTAI | Hot Stocks07:12 EST BioXcel Therapeutics to expand BXCL701 study into multiple advanced solid tumors - BioXcel Therapeutics announced that the Company will advance the clinical evaluation of BXCL701 into multiple advanced solid tumors. BXCL701 is an orally active, systemic innate immunity activator with dual mechanisms of action. The open-label Phase 2 basket trial will take place at a leading cancer center in the U.S. The study is designed to evaluate the response rate of orally administered BXCL701, combined with Pembrolizumab in patients with advanced solid cancers. If successful, the study would provide an option for patients who have failed or are refractory to checkpoint therapy. Outcome measures will include progression-free-survival, overall survival, and duration of response, as well as the safety of the combined treatment.
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WSR | Hot Stocks07:11 EST Whitestone REIT acquires Las Colina Village, terms not disclosed - Whitestone REIT acquired Las Colinas Village, a 104,915 square foot center in Las Colinas, Texas, an upwardly mobile, young professional community of Irving, Texas along North Dallas' "Platinum Corridor." Las Colinas Village is located on an intersection with a daytime VPD of 187,000 and an average 3-mile radius HHI of $101,000 a year.
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VIE | Hot Stocks07:10 EST Viela Bio initiates Phase 2b trial of VIB4920 in Sjogren's syndrome - Viela Bio announced that the first patient has been dosed in a Phase 2b trial of VIB4920 for the treatment of Sjogren's syndrome-a chronic, systemic autoimmune disease involving inflammation and destruction of the salivary and lacrimal glands which leads to severe dryness and chronic pain. The Phase 2b trial is a randomized, double-blind and placebo-controlled trial designed to evaluate the efficacy and safety of VIB4920 in participants with Sjogren's syndrome. For additional information about this clinical trial, please visit clinicaltrials.gov, identifier NCT04129164.
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XCUR | Hot Stocks07:09 EST Exicure announces update from AST-008 trial, to enroll patients in Phase 2 study - Exicure announced an update from its Phase 1b/2 trial with AST-008 in patients with solid tumors. AST-008 is an investigational SNA consisting of toll-like receptor 9, or TLR9, agonists designed for immuno-oncology application and is being evaluated in combination with pembrolizumab in patients with solid tumors. The primary objective of the dose escalation portion of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AST-008 alone and in combination with pembrolizumab, and to produce a recommended Phase 2 dose. Fourteen patients have been enrolled and dosed with AST-008. No treatment-related serious adverse events or dose-limiting toxicities have been observed. The fifth and final dose escalation cohort is now open and enrolling. The study has enrolled five melanoma patients, four Merkel cell carcinoma, or MCC, patients, two cutaneous squamous cell carcinoma patients, two head and neck squamous cell carcinoma patients, and one mucosal melanoma patient. Prior to enrolling, most patients had progressive disease on anti-PD-L1 antibodies. AST-008 administration, alone or in combination with pembrolizumab, produced cytokine and chemokine expression and immune cell activation in patient blood indicative of desired immune activation. Of the 4 MCC patients, one patient, which had previously progressed on anti-PD-1 antibody therapy, has confirmed stable disease with decreased target lesion diameters for a period in excess of twelve weeks, while a second MCC patient experienced a target lesion complete response and a confirmed overall partial response longer than 24 weeks. Nine patients had progressive disease, two patients have not yet been evaluated and one is not evaluable. Detailed results are expected to be presented at major upcoming oncology meetings. Based on these early results, showing biomarker data and initial tumor responses, Exicure anticipates enrolling MCC patients, which have previously failed anti PD-1/PD-L1 therapy, in its Phase 2 study during Q1 of 2020.
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BCRX | Hot Stocks07:08 EST BioCryst submits NDA for oral, once daily berotralstat for HAE attacks - BioCryst Pharmaceuticals announced it has submitted a new drug application to the U.S. Food and Drug Administration for approval of oral, once daily berotralstat for the prevention of hereditary angioedema attacks.
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PTI | Hot Stocks07:08 EST Proteostasis begins trial of proprietary modulators in cystic fibrosis - Proteostasis announced positive, initial ex-vivo results of its proprietary cystic fibrosis, or CF, transmembrane conductance regulator - CFTR - modulators, PTI-801, PTI-808, and PTI-428, in individuals with CF who are ineligible for the current standard of care CFTR modulator therapies due to their genotype. The data are part of a pan-European strategic initiative which seeks to accelerate the development of, and access to, personalized therapies for CF patients, beginning with those for whom no currently approved CFTR modulator therapy is indicated. Early results support the initiation of enrollment of responding subjects into HIT-CF's clinical trial known as "CHOICES", which is designed to evaluate the translation of organoid ex-vivo response to potential clinical benefit, such as changes in FEV1 and sweat chloride. CHOICES, which is expected to initiate in mid-2020, will be the first ever personalized medicine-based study in CF, with initial data expected by the end of 2020. The results may serve as the basis for a potential Marketing Authorization Application with the European Medicines Agency in 2021 through a novel regulatory pathway. Results from the HIT-CF project to date will be presented in January 2020.
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UNFI | Hot Stocks07:06 EST United Natural Foods reports Q1 gross margin 12.81% of net sales - Gross margin for the first quarter was 12.81% of net sales compared to 14.38% of net sales for the first quarter of fiscal 2019, which included a $1.8M, or 0.06% of net sales, inventory fair value adjustment related to the Supervalu acquisition. The decline in the gross margin rate was primarily driven by the addition of Supervalu at a lower gross profit rate.
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JBLU | Hot Stocks07:04 EST JetBlue reports November traffic up 3.7% - JetBlue reported its preliminary traffic results for November. Traffic in November increased 3.7% from November 2018, on a capacity increase of 7.1%. Load factor for November was 80.8%, a decrease of 2.7 points from November 2018. JetBlue's preliminary completion factor for November was 99.9% and its on-time performance was 80.4%. JetBlue expects Q4 revenue per available seat mile to range between (3.5%) and (1.5%), driven by softer than expected close-in yields in late November, combined with the negative impact of weather over the Thanksgiving holiday peak.
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UNFI | Hot Stocks07:04 EST United Natural Foods CEO says 'we remain confident that UNFI is well-positioned' - "We entered the new fiscal year operating with an unmatched geographic footprint, the largest variety of products and services in the industry and the critical scale needed to succeed over the long term. We delivered first quarter results in-line with our expectations and are pleased to reaffirm our fiscal 2020 outlook for net sales, Adjusted EBITDA and Adjusted EPS," said Steven Spinner, Chairman and CEO. "We remain confident that UNFI is well-positioned today and for the future to deliver an industry-leading and sustainable supply chain platform for all customer channels. As we look to the remainder of fiscal 2020, we are committed to converting our sales momentum into improved earnings and cash flow."
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UNFI | Hot Stocks07:03 EST United Natural Foods backs FY20 adjusted EBITDA view $560M-$600M
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STAA | Hot Stocks07:03 EST STAAR Surgical announces FDA IDE clinical study approval - STAAR Surgical is announcing that the FDA in a letter dated December 6, 2019, stated that it has determined that STAAR has provided sufficient data to support initiation of a human clinical study in the United States of the EVO/EVO+ VISIAN Implantable Collamer Lens for Myopia, and EVO/EVO+ VISIAN Toric Implantable Collamer Lens for Myopia with Astigmatism. "Initiating the clinical trial is an important step towards the future availability of the EVO Visian ICL family of products in the U.S. STAAR's plan for the study includes 300 subjects with a primary endpoint at six months follow-up."
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LLY | Hot Stocks06:47 EST Eli Lilly opens LIBRETTO-431 clinical trial for selpercatinib - Eli Lilly announced the opening of the LIBRETTO-431 clinical trial for selpercatinib, also known as LOXO-292, for treatment-naive RET fusion-positive non-small cell lung cancer, or NSCLC, patients. Enrolled trial participants will be randomized to receive either selpercatinib or platinum-based and pemetrexed therapy with or without pembrolizumab as initial treatment of their advanced or metastatic RET fusion-positive NSCLC. LIBRETTO-431 is a randomized Phase 3 clinical trial of patients with treatment-naive RET fusion-positive NSCLC. The trial will enroll 400 patients with advanced or metastatic RET fusion-positive NSCLC who have received no prior systemic therapy for metastatic disease. Enrolled trial participants will be randomized 1:1 to receive either selpercatinib or platinum-based and pemetrexed therapy with or without pembrolizumab as initial treatment of their advanced or metastatic RET fusion-positive NSCLC. RET fusions may be identified using local testing. This trial's primary endpoint is progression-free survival and secondary endpoints include overall survival, overall response rate, duration of response and intracranial ORR. For patients randomized to the control arm, crossover is allowed at progression.
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LAZ | Hot Stocks06:46 EST Lazard reports preliminary AUM approximately $236.7B as of November 30 - The month's AUM included market appreciation of $3.8B; net outflows of $1.5B and foreign exchange depreciation of $1.4B.
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WDR | Hot Stocks06:45 EST Waddell & Reed reports preliminary AUM $69.4B as of November 30 - Compared to $68.9B on October 31. Net flows in the institutional channel included $572M related to the loss of a subadvisory relationship.
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AMZN | Hot Stocks06:21 EST U.K. CMA says Amazon's Deliveroo investment raises competition concerns - Earlier this year, Amazon announced a substantial investment in Deliveroo, which would give it a minority shareholding along with certain other rights, allowing it to participate in the management of the company. While Amazon would not take full control of Deliveroo's business, the CMA has assessed how the deal could enable it to influence Deliveroo's business strategy. "The CMA has also considered the possible effects this influence could have on competition in markets where the 2 companies compete at present - or could compete in the future. The CMA's initial investigation has found that the investment, in its current form, could harm competition in 2 ways. Firstly, it is concerned that the deal could damage competition in online restaurant food delivery by discouraging Amazon from re-entering the market in the UK. Currently, there are only a small number of companies that act as the middle-man between restaurants and customers, and Amazon offered this service in competition with Deliveroo until 2018, when it exited the market. Secondly, the CMA is concerned that the deal could also damage competition in the emerging market for online convenience grocery delivery, where the 2 companies have already established market-leading positions." The companies now have 5 working days to offer legally-binding proposals to the CMA to address the competition concerns identified. The CMA would then have 5 working days to consider whether to accept the offer instead of referring the case to an in-depth investigation. Reference Link
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SYBX | Hot Stocks06:08 EST Synlogic obtains maximum dosage for phenylketonuria candidate - Synlogic announced that data from the company's bridging study in healthy volunteers of a solid formulation of SYNB1618 support its continued development for the treatment of phenylketonuria, or PKU. Synlogic expects to initiate a Phase 2 clinical trial of SYNB1618 to evaluate its potential to lower blood phenylalanine, or Phe, in patients with PKU in the first half of 2020. "We are pleased with the results of this study, which have allowed us to select a maximum tolerated dose of the solid, oral formulation of SYNB1618 to move into a Phase 2 clinical trial," said Richard Riese, Chief Medical Officer. "Incorporating what we have learned, we expect to initiate a clinical trial in patients with PKU that will assess the Phe-lowering potential of SYNB1618 and confirm our modeling. We look forward to presenting the full data set from our bridging study at an appropriate scientific meeting, and to providing more detail regarding the Phase 2 clinical trial design at a later date." In addition to identifying a maximum tolerated dose, the study demonstrated that a dose ramp improved SYNB1618 tolerability and that pH buffering was required for maximum Phe-consuming activity of the strain.
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DIN | Hot Stocks06:08 EST Dine Brands' IHOP to launch new fast casual concept 'Flip'd' in spring 2020 - IHOP Restaurants announced plans to launch Flip'd by IHOP, a new fast-casual concept in the U.S. The new brand aims to fill a gap in the restaurant space by focusing on freshly-made breakfast foods and beverages with speed and convenience in mind, directly addressing a growing consumer demand in densely populated city centers. Popular lunch and dinner items, including the brand's Ultimate Steakburgers and Buttermilk Crispy Chicken will also be available. IHOP plans to open its first Flip'd concept in Atlanta next April with additional sites in New York City, Washington D.C., Denver, and San Francisco currently under exploration for 2020.
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GEL MUR | Hot Stocks06:06 EST Genesis Energy signs new deepwater GOM transportation agreements with Murphy Oil - Genesis Energy (GEL) announced that it has entered in to agreements with Murphy Exploration & Production Company, a subsidiary of Murphy Oil (MUR), and other interest owners, to provide downstream transportation services for 100% of the crude oil and natural gas production associated with the deepwater Gulf of Mexico Khaleesi / Mormont and Samurai field developments through the new King's Quay floating production system, owned by Murphy and investment funds managed by Ridgewood Energy. The King's Quay FPS, located in Green Canyon Block 433, will process up to 80,000 barrels per day of oil and up to 100M cubic feet of gas per day from the Khaleesi / Mormont and Samurai field developments. The Khaleesi and Mormont field developments are located in Green Canyon blocks 345, 389, 390, 434 and 478, and the Samurai development is located in Green Canyon Block 432. The King's Quay FPS is specifically designed to be able to host additional subsea developments in the future as producers continue to explore and develop neighboring prospects in the Green Canyon area of the Gulf of Mexico.
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NEX | Hot Stocks06:03 EST NexTier Oilfield announces up to $100M capital return program - NexTier Oilfield announced that its board approved a capital return program under which NexTier may expend a total of up to $100M, which may be implemented between now and December 31, 2020, through stock repurchases, dividends or other capital return strategies. As part of the capital return program, the board approved a stock repurchase program of up to $50M of the company's common stock, subject to U.S. Securities and Exchange Commission regulations, stock market conditions, capital needs of the business and other factors.
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BYND | Hot Stocks06:02 EST Beyond Meat launches 'Beyond Beef' in Canada - Canadians can now enjoy even more options at their local grocer's fresh meat counter with the launch of Beyond Beef, a new product from Beyond Meat that's designed to look, cook and taste like ground beef. Canada is the first market outside of the U.S. to offer Beyond Beef.
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RHHBY | Hot Stocks05:46 EST Genentech says FDA accepts sBLA for Xolair for treatment of nasal polyps - Genentech, a member of the Roche Group, announced that the FDA has accepted the company's supplemental Biologics License Application, or sBLA, for Xolair for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. If approved, Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E, or IgE. The FDA is expected to make a decision on approval for this indication by Q3 2020.
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JKS | Hot Stocks05:44 EST JinkoSolar signs agreement with COSCO Shipping - JinkoSolar announced that the company has signed an agreement with COSCO Shipping Lines to use the Greek Port of Piraeus as a distribution hub for the shipment of its renewable energy products in Europe, and in particular for Greece, the Balkans and the EMEA region.
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GOL DAL | Hot Stocks05:26 EST Gol Linhas announces change in shareholding ownership - GOL Linhas (GOL) hereby informs its shareholders and the market in general that it has received a correspondence from its shareholder Delta Air Lines (DAL), dated December 10, informing that they have disposed, through negotiations in trading sessions of the B3 S.A. - Brasil Bolsa Balcao in the past few days, 32,926,025 preferred shares issued by the company, which represented more than 5% of the referred type of shares, and remained with 0 preferred shares issued by the company. Delta informed that: (i) it is a corporation duly organized and existing under the laws of the State of Delaware, the United States of America, and headquartered at 1030 Delta Boulevard, Atlanta Georgia 30354, U.S.A.; (ii) the aforementioned shareholding was held strictly for investment purposes, and Delta had no intention of altering the control of the administrative structure of GOL; (iii) other than the shares sold, Delta does not hold any other securities or derivatives in connection with or referred to shares of GOL; and (iv) Delta has not entered into any contracts or agreements regulating the exercise of voting rights or the purchase or sale of securities of GOL. After today's sale of shares by Delta, GOL Airlines is now one of the most liquid stocks on the B3 Brazilian Stock Exchange, with a free float of approximately 47% of total shares outstanding and an expected average daily trading volume of R$200 million per day. This new level of market float is expected to place GOL as the most liquid airline stock in Latin America and amongst most liquid of all publicly traded stocks in Brazil.
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TALO | Hot Stocks05:14 EST Talos Energy announces acquisition of Gulf of Mexico portfolio - Talos Energy announced that the company has entered into a series of definitive agreements to acquire a broad portfolio of U.S. Gulf of Mexico producing assets, exploration prospects and acreage from affiliates of ILX Holdings, Castex Energy and Venari Resources for $640M as of the effective date. Specifically, Talos has signed definitive agreements to acquire all producing assets, primary term acreage and prospects of ILX Holdings, all producing assets and certain primary term acreage and prospects of ILX Holdings II, all primary term acreage and prospects of ILX Holdings III and certain subsidiaries of the Castex 2014 and Castex 2016 entities. In a separate transaction, Talos executed a purchase and sale agreement and closed on the acquisition of all primary term acreage and prospects from Venari Resources. The Acquired Assets produced approximately 19 thousand barrels of oil equivalent per day ("MBoe/d") during the third quarter of 2019 and had proved and probable reserves of approximately 68 million barrels of oil equivalent as of the effective date of July 1. 83% of the Proved reserves are considered Proved Developed. In addition, the Transaction includes over 40 identified exploration prospects located on a total acreage footprint of approximately 700,000 gross acres. Closing of the ILX Acquisitions and Castex Acquisitions is expected in the first quarter of 2020.
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